Artes Medical
Filed Pursuant to Rule 424(b)(4)
Registration No. 333-134086
PROSPECTUS
4,600,000 Shares
Common Stock
Prior to this offering, there has been no public market for our
common stock. The initial public offering price of our common
stock is $6.00 per share. Our common stock has been approved for
quotation on the Nasdaq Global Market under the symbol
ARTE.
We have granted the underwriters an option to purchase, on the
same terms and conditions set forth below, a maximum of 690,000
additional shares if the underwriters sell more than
4,600,000 shares in this offering.
Certain of our existing stockholders have indicated an interest
in purchasing up to approximately 800,000 shares of our
common stock in this offering at the initial public offering
price. However, because indications of interest are not binding
agreements or commitments to purchase, our underwriters may
determine not to sell shares in this offering to our existing
stockholders, or our stockholders may decide not to purchase
shares in this offering.
Investing in our common stock involves risks. See Risk
Factors beginning on page 9.
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Underwriting | |
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Discounts and | |
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Proceeds to Artes | |
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Price to Public | |
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Commissions | |
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Medical, Inc. | |
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Per share
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$6.00 |
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$0.42 |
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$5.58 |
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Total
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$27,600,000 |
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$1,932,000 |
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$25,668,000 |
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Delivery of the shares of common stock will be made on or about
December 26, 2006.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
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Cowen and Company |
Lazard Capital Markets |
Stifel Nicolaus
The date of this prospectus is December 19, 2006.
TABLE OF CONTENTS
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F-1 |
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You should rely only on the information contained in this
prospectus. We have not, and the underwriters have not,
authorized anyone to provide you with different information. If
anyone provides you with different or inconsistent information
you should not rely on it. We are not, and the underwriters are
not, making an offer to sell these securities in any
jurisdiction where an offer or sale is not permitted. You should
assume that the information appearing in this prospectus is
accurate as of the date on the front cover of this prospectus
only, regardless of the time of delivery of this prospectus or
of any sale of our common stock. Our business prospects,
financial condition and results of operations may have changed
since that date.
No action is being taken in any jurisdiction outside of the
United States to permit a public offering of the common stock or
possession or distribution of this prospectus in that
jurisdiction. Persons who come into possession of this
prospectus in any jurisdiction outside of the United States are
required to inform themselves about and to observe any
restrictions as to this offering and the distribution of this
prospectus applicable to that jurisdiction.
PROSPECTUS SUMMARY
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This prospectus summary highlights selected information
appearing elsewhere in this prospectus. Because this is only a
summary, it does not contain all the information that may be
important to you. You should carefully read this prospectus in
its entirety before investing in our common stock, especially
the risks of investing in our common stock, which we discuss
later in Risk Factors, and our financial statements
and related notes beginning on page F-1. Unless the context
requires otherwise, the words Artes, we,
the Company, us and
our refer to Artes Medical, Inc. and our subsidiary,
Artes Medical Germany GmbH (formerly MediPlant GmbH
Biomaterials & Medical Devices). |
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Artes Medical, Inc.
Overview
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We are a medical technology company focused on developing,
manufacturing and commercializing a new category of injectable
aesthetic products for the dermatology and plastic surgery
markets. On October 27, 2006, the U.S. Food and Drug
Administration, or the FDA, approved ArteFill, our
non-resorbable aesthetic injectable implant for the correction
of facial wrinkles known as smile lines, or nasolabial folds.
Currently, there are two categories of injectable aesthetic
products used for the treatment of facial wrinkles: temporary
muscle paralytics, which block nerve impulses to temporarily
paralyze the muscles that cause facial wrinkles, and temporary
dermal fillers, which are injected into the skin or deeper
facial tissues beneath a wrinkle to help reduce the appearance
of the wrinkle. Unlike existing temporary muscle paralytics and
temporary dermal fillers, which are comprised of materials that
are completely metabolized and absorbed by the body, ArteFill is
a proprietary formulation comprised of polymethylmethacrylate,
or PMMA, microspheres and bovine collagen, or collagen derived
from calf hides. PMMA is one of the most widely used artificial
materials in implantable medical devices, and is not absorbed or
degraded by the human body. Following injection, the PMMA
microspheres in ArteFill remain intact at the injection site and
provide a permanent support structure to fill in the existing
wrinkle and help prevent further wrinkling. As a result, we
believe that ArteFill will provide patients with aesthetic
benefits that may last for years. |
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We conducted a controlled, randomized, double-masked,
prospective, multi-center U.S. clinical trial of 251 patients,
in which 128 patients received ArteFill, and 123 patients
received a control of either
Zyderm®
or
Zyplast®,
the leading bovine collagen-based temporary dermal fillers at
that time. Patients who received ArteFill in our clinical trial
showed wrinkle correction that persisted six months after
treatment. In contrast, patients who received the collagen
control in our clinical trial had returned to their
pre-treatment status by their six-month evaluation. As provided
in the study protocol, we offered all control group patients the
opportunity to be treated with ArteFill at their six-month
evaluation, and 91% of these patients accepted our offer. The
safety profiles for ArteFill and the collagen control were
comparable. In the 111 patients who were treated with
ArteFill and remained in the study at 12 months after
treatment, ArteFill demonstrated continued safety and wrinkle
correction. We did not evaluate the patients who received the
collagen control at 12 months after treatment because these
patients had either elected to be treated with ArteFill at their
six-month evaluation period or had returned to their
pre-treatment status. Our promotion of the efficacy benefits of
ArteFill is limited to the six-month efficacy evaluation period
that we established as the official endpoint in our
U.S. clinical trial. |
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We are currently conducting ongoing evaluations of the patients
who received ArteFill in our U.S. clinical trial and
qualify for long-term follow-up. The evaluation of the first
69 patients indicates that these patients have experienced
sustained aesthetic improvement five years after their initial
treatment with ArteFill and have expressed high levels of
satisfaction with their ArteFill treatment. The lead
investigator in our U.S. clinical trial presented the
preliminary findings of our five-year
follow-up patient
evaluations, which included the results of evaluations for these
69 patients, at a conference of the American Society of
Plastic Surgeons held in San Francisco, California in October
2006. The interim data have also been published in the
September 1, 2006 supplement to Plastic and
Reconstructive Surgery, a peer-reviewed journal. |
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1
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We intend to commence commercial shipments of ArteFill during
the first quarter of 2007. We plan to sell ArteFill to
dermatologists, plastic surgeons and cosmetic surgeons in the
United States primarily through a direct sales force initially
comprised of up to 25 sales professionals. We initially intend
to target dermatologists, plastic surgeons and cosmetic surgeons
whom we have identified as having performed a large number of
procedures involving injectable aesthetic products. Based on our
market research, we believe that a majority of injectable
aesthetic procedures are performed by approximately 1,000
physicians who are concentrated in major urban centers in the
United States. In connection with our product launch, we will
train physicians in the technique of injecting ArteFill with the
goal of optimizing patient and physician satisfaction with our
product. After establishing ArteFill in the United States, we
plan to explore opportunities to register and sell ArteFill in
selected international markets. |
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Injectable Aesthetic Market Opportunity
Aesthetic procedures include non-surgical and surgical
treatments to improve or enhance a patients physical
appearance. According to the American Society for Aesthetic
Plastic Surgery, or the ASAPS, injectable aesthetic treatments
are the largest and the fastest growing segment of the
non-surgical aesthetic treatment market. Injectable aesthetic
products are administered through a syringe into the facial skin
or deeper facial tissues in order to reduce the appearance of
facial wrinkles and scars and to add fullness to the lips and
cheeks. The ASAPS reported that, in 2005, approximately
4.9 million injectable aesthetic procedures were performed
in the United States, and U.S. consumers spent
approximately $2.2 billion on injectable aesthetic
treatments. Based on market research conducted by Medical
Insight, Inc., we believe that physicians purchased
approximately $600 million of injectable aesthetic products
for these treatments. Most aesthetic procedures are considered
elective procedures, the cost of which must be paid for directly
by patients, and are not reimbursable through government or
private health insurance.
Currently, there are two categories of injectable aesthetic
products: temporary muscle paralytics and temporary dermal
fillers. Temporary muscle paralytics block nerve impulses to
temporarily paralyze the muscles that cause facial wrinkles.
Temporary dermal fillers are injected into the skin or deeper
facial tissues to plump up the skin under a wrinkle
or scar, or to add fullness to tissues such as lips and cheeks.
However, the substances contained in these products are
completely metabolized and absorbed by the body over time,
resulting in significant limitations, including:
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repeat injections required for patients to sustain aesthetic
benefits; |
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cumulative cost of repeat injections; |
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risk to physician practices of patient attrition; and |
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limited utility in conjunction with aesthetic surgical
procedures. |
Industry research conducted by Medical Insight, Inc. projects
that the market for injectable dermal filler treatments will
expand at a compound annual growth rate through 2011 of more
than 25% in the United States and 20% throughout the rest of the
world. We believe this projected growth is based in part on the
introduction of new longer-lasting products, an increasing
demand for minimally invasive and cost-effective treatments that
offer immediate results, a favorable demographic shift due to
the aging of the baby boomers, and a growing emphasis on
self-image driven by the media and an increasingly
youth-oriented culture.
ArteFill Our Injectable Aesthetic Product
ArteFill is a novel and proprietary aesthetic injectable implant
for the correction of nasolabial folds, or smile lines. In
October 2006, the FDA approved ArteFill for commercial sale in
the United States. ArteFill is the first product in a new
category of non-resorbable aesthetic injectable products for the
dermatology and plastic surgery markets. Unlike existing
temporary muscle paralytics and temporary dermal fillers, which
are comprised of materials that are completely metabolized and
absorbed by the body, ArteFill is comprised of a proprietary
combination of PMMA microspheres and purified bovine collagen.
Following injection, the microspheres remain intact at the
injection site and provide a permanent support structure to fill
in the
2
existing wrinkle and help prevent further wrinkling. As a
result, we believe that ArteFill will provide patients with
aesthetic benefits that may last for years. We believe that
ArteFill will offer the following benefits:
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enduring aesthetic improvements; |
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compelling value proposition to patients; |
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high levels of patient satisfaction; |
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differentiated, high value product for physician
practices; and |
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complement to surgical and non-surgical aesthetic treatments. |
Our Strategy
Our goal is to become a leading medical technology company
focused on developing, manufacturing and commercializing a new
category of injectable aesthetic products for the dermatology
and plastic surgery markets. We plan to achieve this goal
through the following strategies:
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establish ArteFill as a leading injectable aesthetic product; |
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provide physicians with comprehensive education and training
programs; |
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drive the adoption of ArteFill through a direct sales and
marketing effort; and |
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expand our product offering by acquiring complementary products,
technologies or businesses. |
Risks Associated with Our Business
Our business is subject to numerous risks, as discussed more
fully in the section entitled Risk Factors
immediately following this prospectus summary. From inception
through September 30, 2006, we had an accumulated deficit
of approximately $71.6 million. We expect to continue to incur
significant losses in the future as we commercialize ArteFill,
and we may never generate sufficient revenues to achieve or
sustain profitability. Because we have limited operating
experience and plan to enter into the rapidly evolving market
for injectable aesthetic products, we may not be able to
successfully predict or react to relevant industry developments
and business trends. Although the FDA has approved ArteFill for
sale in the United States, we will not be able to achieve our
business objectives if we cannot effectively build and use our
sales and marketing organization to achieve sufficient market
acceptance of ArteFill. We also face significant competition
from companies with greater resources and well-established sales
channels, which may make it difficult for us to achieve market
penetration. In addition, ArteFill will be subject to ongoing
regulatory review, and any failure to comply with continuing
regulation by the FDA or other regulatory bodies could subject
ArteFill to a product recall or other regulatory action, which
would seriously harm our business.
3
Additional Information
Our business was incorporated in Delaware in 1999. Our principal
executive offices are located at 5870 Pacific Center
Boulevard, San Diego, California 92121, and our telephone
number is
(858) 550-9999.
Our website is located at http://www.artesmedical.com.
The information contained in, or that can be accessed through,
our website is not part of this prospectus.
Artes
Medical®,
Artes®,
our logo,
ArteFill®,
The Art of Soft Tissue
Augmentationtm,
The First to
Lasttm,
and Enduring
Beauty®
are our trademarks. We have rights to these trademarks in the
United States and have registrations issued and pending in the
United States and other countries. All other service marks,
trademarks, trade names and brand names referred to in this
prospectus are the property of their respective owners.
This prospectus contains market data and industry forecasts that
were obtained from industry publications, third-party market
research and publicly available information. These publications
generally state that the information contained therein has been
obtained from sources believed to be reliable, but the accuracy
and completeness of such information is not guaranteed. While we
believe that the information from these publications is
reliable, we have not independently verified, and make no
representation as to the accuracy of, such information.
4
The Offering
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Common stock offered by us |
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4,600,000 shares |
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Common stock to be outstanding after this offering |
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15,634,343 shares |
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Use of proceeds |
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We estimate that the net proceeds from this offering will be
approximately $21.9 million, or approximately
$25.7 million if the underwriters exercise their
over-allotment option in full, based on the initial public
offering price of $6.00 per share. We intend to use the net
proceeds from this offering to build our sales and marketing
organization and implement promotional and advertising campaigns
related to the commercial launch of ArteFill; to conduct our
long-term, post-market safety study of ArteFill; to further
automate and expand capacity at our manufacturing facilities;
and to conduct further studies to evaluate the feasibility,
safety and efficacy of ArteFill for other aesthetic
applications. We intend to use the remainder of the net proceeds
from this offering for working capital and for other general
corporate purposes. See Use of Proceeds. |
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Nasdaq Global Market symbol |
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ARTE |
The number of shares of our common stock to be outstanding
immediately after this offering is based on:
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10,758,441 shares of common stock outstanding as of
September 30, 2006 after giving effect to the conversion of
all outstanding shares of our preferred stock into
9,367,511 shares of common stock, which will become
effective at the closing of this offering; |
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107,754 shares of our common stock issuable upon the exercise of
preferred stock and common stock warrants outstanding as of
September 30, 2006, at a weighted average exercise price of
$5.58 per share, which the warrant holders have elected to
exercise in cash, contingent and effective upon the closing of
this offering; and |
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168,148 shares of our common stock issuable upon the exercise of
preferred stock and common stock warrants outstanding as of
September 30, 2006, which the warrant holders have elected to
exercise through a cashless exercise provision of
the warrants, contingent and effective upon the closing of this
offering, based on the initial public offering price of $6.00
per share. No shares of common stock will be issued to warrant
holders who have elected to exercise their warrants through
cashless exercise provisions if the exercise price
of their warrants exceeds the initial public offering price of
$6.00 per share. If not exercised through a cashless
exercise, these warrants would have been exercisable for
767,583 shares of common stock, at a weighted average
exercise price of $5.47 per share. |
The number of shares of our common stock outstanding immediately
after this offering excludes:
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1,869,676 shares of our common stock issuable upon the
exercise of stock options outstanding as of September 30,
2006, at a weighted average exercise price of $5.85 per
share; |
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335,246 shares of our common stock issuable upon the
exercise of outstanding stock options granted after
September 30, 2006, at a weighted average exercise price of
$10.63 per share; |
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3,640,843 shares of our common stock available for future
grant under our 2006 Equity Incentive Plan, which number
excludes the cancellation of 121,355 outstanding stock options
canceled after September 30, 2006, at a weighted average
exercise price of $6.30 per share, which will become effective
upon the closing of this offering, and the annual increases in
the number of shares authorized under this plan beginning
January 1, 2007; |
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2,490,189 shares of our common stock issuable upon the
exercise of preferred stock and common stock warrants
outstanding as of September 30, 2006, at a weighted average
exercise price of $6.98 per share; and |
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28,235 shares of common stock issuable upon the exercise of
a preferred stock warrant granted after September 30, 2006,
at an exercise price of $10.63 per share. |
Unless otherwise indicated, all information in this prospectus
assumes:
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that the underwriters do not exercise their option to purchase
up to 690,000 additional shares of our common stock to
cover over-allotments, if any; |
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the completion of a 1-for-4.25 reverse split of our outstanding
common stock immediately before the closing of this offering; |
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the conversion, upon the closing of this offering, of all of the
outstanding shares of preferred stock into 9,367,511 shares
of common stock; |
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no options, warrants or shares of common stock were issued after
the date of this prospectus, and no outstanding options or
warrants were exercised after September 30, 2006; |
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the amendment and restatement of our certificate of
incorporation and bylaws, which will become effective at the
closing of this offering; |
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the adoption of our 2006 Equity Incentive Plan, which will
become effective upon the closing of this offering; and |
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that none of the estimated offering expenses payable by us on
the closing of this offering have been paid. However, as of
September 30, 2006, we have paid in cash approximately
$2.7 million of these expenses. |
Certain of our existing stockholders have indicated an interest
in purchasing up to approximately 800,000 shares of our
common stock in this offering at the initial public offering
price. However, because indications of interest are not binding
agreements or commitments to purchase, our underwriters may
determine not to sell shares in this offering to our existing
stockholders, or our stockholders may decide not to purchase
shares in this offering.
6
Summary Consolidated Financial Data
The following summary consolidated financial data should be read
in conjunction with Selected Consolidated Financial
Data, Managements Discussion and Analysis of
Financial Condition and Results of Operations and our
audited consolidated financial statements and related notes
included elsewhere in this prospectus. We derived the summary
consolidated statements of operations data for the years ended
December 31, 2003, 2004 and 2005 and the summary
consolidated balance sheet data as of December 31, 2005
from our audited consolidated financial statements included
elsewhere in this prospectus. The summary consolidated financial
data at September 30, 2006 and for the nine months ended
September 30, 2005 and 2006 are derived from our unaudited
consolidated financial statements, which are included elsewhere
in this prospectus. Our historical results are not necessarily
indicative of our future results.
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Nine Months Ended | |
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Years Ended December 31, | |
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September 30, | |
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2003 | |
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2004 | |
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2005 | |
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2005 | |
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2006 | |
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(in thousands, except per share data) | |
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(unaudited) | |
Consolidated Statements of Operations Data:
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Expenses:
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Research and development
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$ |
974 |
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$ |
3,634 |
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$ |
10,189 |
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$ |
6,754 |
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$ |
5,698 |
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Selling, general and administrative
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2,976 |
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5,155 |
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10,137 |
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6,723 |
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11,463 |
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Total expenses
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3,950 |
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8,789 |
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20,326 |
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13,477 |
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17,161 |
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Loss from operations
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(3,950 |
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(8,789 |
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(20,326 |
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(13,477 |
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(17,161 |
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Interest expense, net
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(2,170 |
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(4,028 |
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(4,416 |
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(3,518 |
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(1,907 |
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Other income (expense), net
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(22 |
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2,041 |
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(11 |
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351 |
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Loss before benefit for income taxes
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(6,120 |
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(12,839 |
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(22,701 |
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(17,006 |
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(18,717 |
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Benefit for income taxes
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454 |
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458 |
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141 |
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148 |
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Net loss
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$ |
(6,120 |
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$ |
(12,385 |
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$ |
(22,243 |
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$ |
(16,865 |
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$ |
(18,569 |
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Historical net loss per common share:
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Basic and diluted
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$ |
(5.76 |
) |
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$ |
(11.20 |
) |
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$ |
(18.76 |
) |
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$ |
(14.38 |
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$ |
(13.81 |
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Weighted average shares - basic and diluted
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1,062,825 |
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1,106,188 |
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1,185,387 |
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1,172,419 |
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1,344,503 |
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Pro forma net loss per common share (unaudited):
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Basic and diluted
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$ |
(5.15 |
) |
|
|
|
|
|
$ |
(1.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares - pro forma basic and diluted (unaudited)
|
|
|
|
|
|
|
|
|
|
|
4,319,411 |
|
|
|
|
|
|
|
9,885,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation is included in the following categories: |
|
|
|
Capitalized to inventory
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
214 |
|
|
|
|
Research and development
|
|
|
|
|
|
|
91 |
|
|
|
256 |
|
|
|
113 |
|
|
|
267 |
|
|
|
Selling, general and administrative
|
|
|
159 |
|
|
|
1,042 |
|
|
|
1,038 |
|
|
|
389 |
|
|
|
1,324 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
159 |
|
|
$ |
1,133 |
|
|
$ |
1,294 |
|
|
$ |
502 |
|
|
$ |
1,805 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
The following table presents a summary of our consolidated
balance sheet as of September 30, 2006:
|
|
|
|
|
on an actual basis; |
|
|
|
on a pro forma as adjusted basis to give effect to the
conversion of all outstanding shares of convertible preferred
stock, as of September 30, 2006, into shares of common
stock; the issuance of 107,754 shares of our common stock
issuable upon the exercise of preferred stock and common stock
warrants outstanding as of September 30, 2006, at a
weighted average exercise price of $5.58 per share, which the
warrant holders have elected to exercise in cash, contingent and
effective upon the closing of this offering; the issuance of
168,148 shares of our common stock upon the exercise of
preferred stock and common stock warrants outstanding as of
September 30, 2006, which the warrant holders have elected to
exercise through a cashless exercise provision of
the warrants, contingent and effective upon the closing of this
offering, based on the initial public offering price of $6.00
per share; and the sale of the shares of our common stock we are
offering in this offering at the initial public offering price
of $6.00 per share, after deducting underwriting discounts
and commissions and estimated offering expenses to be paid by us. |
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2006 | |
|
|
| |
|
|
|
|
Pro forma | |
|
|
Actual | |
|
as adjusted | |
|
|
| |
|
| |
|
|
(in thousands) | |
|
|
(unaudited) | |
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents(1)
|
|
$ |
12,789 |
|
|
$ |
34,683 |
|
Working capital
|
|
|
12,403 |
|
|
|
34,297 |
|
Total assets
|
|
|
29,745 |
|
|
|
51,639 |
|
Current portion of capital lease obligations
|
|
|
44 |
|
|
|
44 |
|
Long-term debt and capital lease obligations, less current
portion(2)
|
|
|
31 |
|
|
|
31 |
|
Convertible preferred stock
|
|
|
38 |
|
|
|
|
|
Common stock
|
|
|
1 |
|
|
|
16 |
|
Additional paid-in capital
|
|
|
94,144 |
|
|
|
116,061 |
|
Deficit accumulated during the development stage
|
|
|
(71,648 |
) |
|
|
(71,648 |
) |
Total stockholders equity
|
|
|
22,535 |
|
|
|
44,429 |
|
|
|
(1) |
The pro forma as adjusted amount does not include the impact of
approximately $2.7 million of estimated offering costs
already paid in cash by us as of September 30, 2006. |
|
(2) |
The pro forma as adjusted amount does not include the draw down
of $5.0 million under the Companys term loan credit
facility, which occurred in November 2006. See Note 11
of Notes to Consolidated Financial Statements. |
8
RISK FACTORS
Any investment in our common stock involves a substantial
risk of loss. You should consider carefully the risks and
uncertainties described below, together with all the other
information contained in this prospectus, before you decide
whether to purchase our common stock. The risks and
uncertainties described below are not the only ones we face. Our
business, financial condition or results of operations could be
materially harmed by any of these risks. In that case, the
trading price of our common stock could decline, and you may
lose part or all of your investment.
Risks Related to Our Business
|
|
|
We have limited operating experience and a history of net
losses and may never achieve or maintain profitability. |
We have a limited operating history and have focused primarily
on research and development, product engineering, clinical
trials, building our manufacturing capabilities and seeking FDA
approval to market ArteFill. We currently have no products in
commercial distribution. We received FDA approval to market
ArteFill on October 27, 2006, and we intend to commence
commercial shipments of ArteFill during the first quarter of
2007. All of our other product candidates are still in the early
stages of research and development. As a result, we have not
recorded any revenues to date. We have incurred significant net
losses since our inception, including net losses of
approximately $12.4 million in 2004, $22.2 million in
2005 and $18.6 million for the nine months ended
September 30, 2006. At September 30, 2006, we had an
accumulated deficit of approximately $71.6 million. For the
nine months ended September 30, 2006, we used net cash in
operating activities of $16.5 million. We will need to
incur significant sales, marketing and manufacturing expenses in
connection with the commercial launch of ArteFill and expect to
incur significant operating losses for the foreseeable future.
We cannot predict the extent of our future operating losses and
accumulated deficit, and we may never generate sufficient
revenues to achieve or sustain profitability. Even if we do
achieve profitability, we may not be able to sustain or increase
profitability. Further, because of our limited operating history
and because the market for injectable aesthetic products is
relatively new and rapidly evolving, we have limited insight
into the trends that may emerge and affect our business. We may
make errors in predicting and reacting to relevant business
trends, which could harm our business. Before investing, you
should consider an investment in our stock in light of the
risks, uncertainties and difficulties frequently encountered by
early-stage companies in new and rapidly evolving markets such
as ours. We may not be able to successfully address any or all
of these risks. Failure to adequately do so could cause our
business, results of operations and financial condition to
suffer.
|
|
|
Our operating results may fluctuate significantly in the
future, and we may not be able to correctly estimate our future
operating expenses, which could lead to cash shortfalls. |
Our operating results may fluctuate significantly in the future
as a result of a variety of factors, many of which are outside
of our control. These factors include:
|
|
|
|
|
the level of demand for ArteFill; |
|
|
|
the costs of our sales and marketing activities; |
|
|
|
the introduction of new technologies and competing products that
may make ArteFill a less attractive treatment option for
physicians and patients; |
|
|
|
our pricing strategy and ability to protect the price of
ArteFill against price erosion due to the availability of
alternative treatments; |
|
|
|
our ability to attract and retain personnel with the skills
required for effective operations; |
|
|
|
product liability and other litigation; |
|
|
|
the amount and timing of capital expenditures and other costs
relating to conducting our long-term, post-market safety study
for ArteFill, further automating and expanding capacity at our |
9
|
|
|
|
|
manufacturing facilities and conducting further studies
regarding the use of ArteFill for other aesthetic applications; |
|
|
|
government regulation and legal developments regarding our
products in the United States and in the foreign countries in
which we operate; |
|
|
|
our ability to receive, and the timing in which we may receive,
approval from various foreign regulatory bodies to market
ArteFill outside the United States; and |
|
|
|
general economic conditions affecting the ability of patients to
pay for elective cosmetic procedures. |
Because we have not commenced commercial shipments of our
product, and due to the emerging nature of the injectable
aesthetic product market in which we will compete, our
historical financial data is of limited value in estimating
future operating expenses. Our projected expense levels are
based in part on our expectations concerning future revenues.
However, our ability to generate any revenues depends on the
successful commercial launch of ArteFill. Moreover, the amount
of any future revenues will depend on the choices and demand of
physicians and patients, which are difficult to forecast
accurately. We believe that patients are more likely to pay for
elective cosmetic procedures when the economy is strong, and as
a result, any material adverse change in economic conditions may
negatively affect our revenues. We may be unable to reduce our
expenditures in a timely manner to compensate for any unexpected
shortfall in revenues. Accordingly, a significant shortfall in
demand for our products could have an immediate and material
adverse effect on our business, results of operations and
financial condition. Further, our manufacturing costs and sales
and marketing expenses will increase significantly as we expand
our operations to commercialize ArteFill. To the extent that
expenses precede or are not followed by increased revenue, our
business, results of operations and financial condition may be
harmed.
An investigation by the FDA or other regulatory agencies,
including the current investigation by the FDAs Office of
Criminal Investigations, which we believe may concern improper
uses of our product before FDA approval, could harm our
business.
During negotiations with the parties involved in the litigation
with Elizabeth Sandor discussed below, Dr. Gottfried
Lemperle, our former Chief Scientific Officer and a former
member of our board of directors, informed us that his counsel
had contacted an investigator in the FDAs Office of
Criminal Investigations to determine whether any investigation
of Dr. Gottfried Lemperle was ongoing. In March 2006,
Dr. Gottfried Lemperles counsel informed us that an
investigator at the FDA informed her that the FDA has an open
investigation regarding us, Dr. Gottfried Lemperle and his
son, Dr. Stefan Lemperle, our former Chief Executive
Officer and a former director, that the investigation had been
ongoing for many months, that the investigation would not be
completed within six months, and that when the investigation is
completed, it could be referred to the U.S. Attorneys
Office for criminal prosecution. In November 2006, we contacted
the FDAs Office of Criminal Investigations. That office
confirmed the ongoing investigation involving the Company, but
declined to provide any details of the investigation, including
the timing, status, scope or targets of this investigation.
To our knowledge, prior to or following this inquiry, neither
Dr. Gottfried Lemperle, Dr. Stefan Lemperle nor any of our
current officers or directors has been contacted by the FDA in
connection with an FDA investigation. As a result, we have no
direct information from the FDA regarding the subject matter of
this investigation. We believe that the investigation may relate
to the facts alleged in the Sandor litigation and the following
correspondence from and to the FDA. In July 2004, we received a
letter from the FDAs Office of Compliance indicating that
the FDA had received information suggesting that we may have
improperly marketed and promoted ArteFill prior to obtaining
final FDA approval. In addition, we received a letter from the
FDAs MedWatch program, the FDAs safety information
and adverse event reporting program, on April 21, 2005,
which included a Manufacturer and User Facility Device
Experience Database, or MAUDE, report. The text of the MAUDE
report contained facts similar to those alleged by the plaintiff
in the Sandor litigation.
10
We responded to the FDAs correspondence in August 2004 and
again in May 2006. In our responses, we informed the FDA that
based on our internal investigations, Dr. Gottfried
Lemperle had used Artecoll, a predecessor product to ArteFill,
on four individuals in the United States. Artecoll has been
manufactured and sold by unrelated third parties outside the
United States under a CE mark since 1996. In 2004, we acquired
all worldwide intellectual property rights related to Artecoll
and a facility used to produce PMMA microspheres. Following this
acquisition, we requested these third parties to cease
manufacturing and distributing their product named Artecoll. We
have never manufactured, sold or received any revenues from
Artecoll. We initially named the product used in our clinical
trials as Artecoll, but later changed the name of our product
candidate to ArteFill to reflect refinements that we have made
to the PMMA microsphere manufacturing process following our
acquisition of the rights to Artecoll.
We also stated in our correspondence to the FDA that we found no
evidence that any of the Artecoll used in the U.S. clinical
study was used improperly before or after receipt of the
approvable letter from the FDA in January 2004. We also informed
the FDA that we could not conclusively determine the source of
the Artecoll used on the four individuals, that
Dr. Gottfried Lemperles use of Artecoll was not part
of a study or any activity sponsored by us and that
Dr. Gottfried Lemperle had resigned from his position as
Chief Scientific Officer and as a member of our board of
directors. In addition to our correspondence to the FDA, we also
informed the FDA of these matters during its inspection of our
manufacturing facilities in San Diego, California in April
2006. In May 2006, we received the FDAs Establishment
Inspection Report, or EIR, for its investigation of our San
Diego manufacturing facility. The EIR referenced two anonymous
consumer complaints received by the FDA. The first complaint,
received by the FDA in December 2003, alleges that Dr. Stefan
Lemperle promoted the unapproved use of ArteFill, providing,
upon request, a list of local doctors who could perform
injections of ArteFill. The second complaint, received by the
FDA in June 2004, alleges complications experienced by an
individual who had been injected with ArteFill by Dr. Gottfried
Lemperle in his home. The second complaint further alleges that
Dr. Stefan Lemperle marketed unapproved use of ArteFill. In May
2006, we terminated Dr. Gottfried Lemperles
consulting relationship with us. Dr. Gottfried Lemperle no
longer provides services to us in any capacity.
In July 2006, the FDA requested us to submit an amendment to our
pre-market approval, or PMA, application for ArteFill containing
a periodic update covering the time period between
January 16, 2004, the date of our approvable letter, and
the date of the amendment. The FDA requested our periodic update
to include, among other things, all information available to us
regarding individuals who had been treated with Artecoll outside
our clinical trials and any adverse events these individuals had
experienced. In response to this request, we completed
additional inquiries regarding Dr. Gottfried
Lemperles unauthorized uses of Artecoll outside our
clinical trials in contravention of FDA rules and regulations.
In August 2006, we filed an amendment to our pre-market approval
application that included the periodic update requested by the
FDA. In the amendment, we informed the FDA that as a result of
our additional inquiries, we had identified nine individuals who
had been treated with Artecoll in the United States by
Dr. Gottfried Lemperle, four of whom we had disclosed to
the FDA in our prior correspondence. We also informed the FDA
that 16 individuals had been treated with Artecoll by physicians
in Mexico or Canada, where Artecoll is approved for treatment,
in connection with physician training sessions conducted in
those countries. Further, we informed the FDA that
Dr. Stefan M. Lemperle, our then-serving Chief Executive
Officer and director, had been injected with Artecoll in the
United States in 2004 by his father, Dr. Gottfried
Lemperle. Prior to the time we conducted the additional
inquiries to prepare our periodic update for the FDA,
Dr. Stefan M. Lemperle had failed to disclose to us, or to
the FDA, that he had been injected with Artecoll in
contravention of FDA rules and regulations. In October 2006, our
board of directors removed Dr. Stefan Lemperle from the position
of Chief Executive Officer, and in November 2006, Dr. Stefan
Lemperle resigned as a director and employee. Dr. Stefan
Lemperle no longer provides services to us in any capacity. We
received FDA approval to market ArteFill on October 27,
2006.
We intend to cooperate fully with any inquiries by the FDA or
any other authorities regarding these and any other matters. We
have no information regarding when any investigation may be
concluded, and we are unable to predict the outcome of the
foregoing matters or any other inquiry by the FDA or any other
authorities. If the FDA or any other authorities elect to
request additional information from us or to
11
commence further proceedings, responding to such requests or
proceedings could divert managements attention and
resources from our operations. We would also incur additional
costs associated with complying with any such requests or
responding to any such proceedings. Additionally, any negative
developments arising from such requests or the investigation
could potentially harm our relationship with the FDA. Any
adverse finding resulting from the ongoing FDA investigation
could result in a warning letter from the FDA that requires us
to take remedial action, fines or other criminal or civil
penalties, the referral of the matter to another governmental
agency for criminal prosecution and negative publicity regarding
our company. Any of these events could harm our business and
negatively affect our stock price.
|
|
|
We expect to derive substantially all of our future
revenue from sales of Artefill, and if we are unable to achieve
and maintain market acceptance of ArteFill among physicians and
patients, our business, operating results and financial
condition will be harmed. |
We expect sales of ArteFill to account for substantially all of
our revenue for at least the next several years. Accordingly,
our success depends on the acceptance among physicians and
patients of ArteFill as a preferred injectable aesthetic
treatment. Even though we have received FDA approval to market
ArteFill in the United States, we may not achieve and maintain
market acceptance of ArteFill among physicians or patients.
ArteFill is the first product in a new category of
non-resorbable aesthetic injectable products in the United
States. As a result, the degree of market acceptance of ArteFill
by physicians and patients is unproven and difficult to predict.
We believe that market acceptance of ArteFill will depend on
many factors, including:
|
|
|
|
|
the perceived advantages or disadvantages of ArteFill compared
to other injectable aesthetic products and alternative
treatments; |
|
|
|
the safety and efficacy of ArteFill and the number and severity
of reported adverse side effects, if any; |
|
|
|
the availability and success of other injectable aesthetic
products and alternative treatments; |
|
|
|
the price of ArteFill relative to other injectable aesthetic
products and alternative treatments; |
|
|
|
our success in building a sales and marketing organization and
the effectiveness of our marketing, advertising and
commercialization initiatives; |
|
|
|
the willingness of patients to wait 28 days for treatment
following the bovine collagen skin test that is required in
connection with ArteFill; |
|
|
|
our ability to provide additional clinical data regarding the
potential long-term aesthetic benefits provided by ArteFill; |
|
|
|
our success in training physicians in the proper use of the
ArteFill injection technique and the convenience and ease of
administration of ArteFill; |
|
|
|
the success of our physician practice support programs; and |
|
|
|
publicity concerning ArteFill or competing products and
alternative treatments. |
We cannot assure you that ArteFill will achieve market
acceptance among physicians and patients. Because we expect to
derive substantially all of our revenue for the foreseeable
future from sales of ArteFill, any failure of this product to
satisfy physician or patient demands or to achieve meaningful
market acceptance will seriously harm our business.
|
|
|
We face significant competition from companies with
greater resources and well-established sales channels, which may
make it difficult for us to achieve market penetration. |
The market for injectable aesthetic products is extremely
competitive, subject to rapid change and significantly affected
by new product introductions and other market activities of
industry participants. Our competitors primarily consist of
companies that offer non-permanent injectable aesthetic products
approved
12
by the FDA for the correction of facial wrinkles, as well as
companies that offer products that physicians currently use
off-label for the correction of facial wrinkles. These companies
include:
|
|
|
|
|
Allergan, Inc., which markets and sells
Botox®
Cosmetic, a temporary muscle paralytic and the most widely used
injectable aesthetic product in the United States,
CosmoDerm®
and
CosmoPlast®,
which are human collagen-based temporary dermal fillers,
Zyderm®
and
Zyplast®,
which are bovine collagen-based temporary dermal fillers, and
Hylaform®,
Hylaform®
Plus,
Captique®
and
Juvedermtm,
which are temporary dermal fillers comprised primarily of
hyaluronic acid, a jelly-like substance that is found naturally
in living organisms and acts to hydrate and cushion skin tissue; |
|
|
|
Medicis Pharmaceutical Corporation, which markets and sells
Restylane®,
the leading temporary dermal filler comprised primarily of
hyaluronic acid; |
|
|
|
BioForm Medical, Inc., which markets and sells
Radiessetm,
which is approved by the FDA for vocal cord augmentation,
radiographic tissue marking and the treatment of oral and
maxillofacial defects, or the loss of facial structure and skin
tissue, and is currently under review by the FDA for other uses,
including aesthetic applications; and |
|
|
|
Dermik Laboratories, a subsidiary of sanofi-aventis, which
markets and sells
Sculptra®,
which is approved by the FDA for restoration and/or correction
of the signs of facial fat loss in people with human
immunodeficiency virus. |
Some of these companies are publicly traded and enjoy
competitive advantages, including:
|
|
|
|
|
superior name recognition; |
|
|
|
established relationships with physicians and patients; |
|
|
|
integrated distribution networks; |
|
|
|
large-scale FDA-approved manufacturing facilities; and |
|
|
|
greater financial resources for product development, sales and
marketing and patent litigation. |
In addition, in March 2006, Allergan completed its acquisition
of INAMED Corporation, which was a manufacturer of various
temporary dermal fillers. As a result of this transaction, the
market for injectable aesthetic products experienced a
significant concentration of products within a single entity
with greater resources and the ability to provide an expanded
range of products and services. These companies and others have
developed and will continue to develop new products that compete
with our products, and the consolidation of such companies may
result in competition from entities with even greater financial
and other resources.
After establishing ArteFill in the United States, we plan to
explore opportunities to register and sell ArteFill in selected
international markets. We primarily intend to use third-party
distributors in international markets, although we may build
direct sales forces to market ArteFill in certain concentrated
markets. Due to less stringent regulatory requirements, there
are many more injectable aesthetic products available for use in
international markets than are approved for use in the United
States. As a result, we may face even greater competition in
these markets than in the United States.
Many of our competitors spend significantly greater funds on the
research, development, promotion and sale of new and existing
products. These resources can enable them to respond more
quickly to new or emerging technologies and changes in customer
requirements. Even if we attempt to expand our technological
capabilities in order to remain competitive, research and
discoveries by others may make ArteFill a less attractive
alternative for physicians and patients. For all the foregoing
reasons, we may not be able to compete successfully against our
current and future competitors. If we cannot compete effectively
in the marketplace, our potential for profitability and our
results of operations will suffer.
13
|
|
|
We have been involved in product litigation in the past,
and we may become involved in product litigation in the future,
and any liability resulting from product liability or other
related claims may negatively affect our results of
operations. |
Dermatologists, plastic surgeons, cosmetic surgeons and other
practitioners who administer ArteFill, as well as patients who
have been treated with ArteFill or any of our future products,
may bring product liability and other claims against us. In
August 2005, Elizabeth Sandor, an individual residing in
San Diego, California, filed a complaint against us and
Drs. Gottfried Lemperle, Stefan Lemperle and Steven Cohen
in the Superior Court of the State of California for the County
of San Diego. The complaint, as amended, set forth various
causes of action against us, including product liability, fraud,
negligence and negligent misrepresentation. The complaint also
alleged that Dr. Gottfried Lemperle, our co-founder, former
Chief Scientific Officer and a former member of our board of
directors, treated Ms. Sandor with Artecoll and/or ArteFill
in violation of medical licensure laws, that the product was
defective and unsafe because it had not received FDA approval at
the time it was administered to Ms. Sandor, and that
Ms. Sandor suffered adverse reactions as a result of the
injections. In addition, the complaint alleged that
Drs. Gottfried Lemperle and Stefan Lemperle, our other
co-founder, former Chief Executive Officer and a former
director, falsely represented to her that the product had
received an approvability letter from the FDA, and was safe and
without the potential for adverse reactions. The complaint also
alleged medical malpractice against Dr. Cohen, the lead
investigator in our U.S. clinical trial, for negligence in
treating Ms. Sandor for the adverse side effects she
experienced. We notified our directors and officers
liability insurance carrier of Ms. Sandors claims and
requested both a defense and indemnification for all claims
advanced by Ms. Sandor. Our insurance carrier declined
coverage. On June 1, 2006, the parties filed a stipulation
to dismiss the case without prejudice and toll the statute of
limitations. The case was dismissed on June 5, 2006, and
the plaintiff is allowed to refile the case at any time within
18 months from that date. See Business
Legal Proceedings.
Any negative publicity surrounding these events or any refiling
of this case may harm our business and negatively impact the
price of our stock. Additionally, if it is determined that
Dr. Gottfried Lemperle or Dr. Stefan Lemperle did not
act in his individual capacity or that we are liable because of
the actions of Dr. Cohen, we may need to pay damages, which
would reduce our cash and could cause a decline in our stock
price. Further, if any of the individuals injected with Artecoll
by Dr. Gottfried Lemperle in the United States, or if any
of those individuals injected with Artecoll during the physician
training sessions conducted in Mexico and Canada bring claims
against the Company as a result of these injections, we may need
to pay damages, which would reduce our cash and could cause a
decline in our stock price. As of the date of this filing, none
of these individuals has filed a claim against the Company in
connection with an injection of Artecoll, except for
Ms. Sandor. There could be other individuals who were
injected with Artecoll who are not known to the Company, who
could bring similar claims against the Company.
To limit our product liability exposure, we have decided to
restrict sales of ArteFill to physicians who have successfully
completed our physician training program. We cannot provide any
assurance that such a training program will help avoid
complications resulting from the administration of ArteFill. In
addition, although we plan to sell our product only to
physicians, we will not be able to control whether other medical
professionals, such as nurse practitioners or other cosmetic
specialists, administer ArteFill to their patients, and we may
be unsuccessful at avoiding significant liability exposure as a
result. We currently maintain limited product liability
insurance in an amount of up to $5 million per incident and
as of December 1, 2006 we will have additional coverage of
$20 million per incident, but any insurance we obtain may
not provide adequate coverage against any asserted claims. In
addition, such additional insurance may not provide coverage for
claims which may be asserted in the future by individuals
injected with Artecoll by Dr. Gottfried Lemperle or during
the physician training sessions conducted in Mexico and Canada.
We also may be unable to obtain insurance in the future on
acceptable terms, or at all. In addition, regardless of merit or
eventual outcome, product liability and other claims may result
in:
|
|
|
|
|
the diversion of managements time and attention from our
business and operations; |
|
|
|
the expenditure of large amounts of cash on legal fees, expenses
and payment of settlements or damages; |
14
|
|
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decreased demand for ArteFill among physicians and patients; |
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voluntary or mandatory recalls of our products; or |
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injury to our reputation. |
If any of the above consequences of product liability litigation
occur, it could adversely affect our results of operations, harm
our business and cause the price of our stock to decline.
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We have never commercialized any product, and the
successful commercialization of ArteFill will require us to
build a sophisticated sales and marketing organization. |
We have no prior experience with commercializing any product,
and we will need to deploy a sophisticated sales and marketing
organization in order to successfully commercialize ArteFill. We
are building a direct sales force to be comprised of up to
25 sales professionals and plan to target dermatologists,
plastic surgeons and cosmetic surgeons whom we have identified
as having significant experience with the tunneling injection
technique used in ArteFill treatments. Selling ArteFill to
physicians will require us to educate them on the comparative
advantages of ArteFill over other injectable aesthetic products
and alternative treatments. Experienced sales representatives
may be difficult to locate and all sales representatives will
need to undergo extensive training. We anticipate that it will
take up to six months for our sales representatives to achieve
full productivity. We will need to incur significant costs to
build our internal sales force. Based on our current operating
plan, we expect to incur costs of approximately
$8.0 million to $12.0 million over a
12-month period in
connection with establishing and building our sales force. There
is no assurance that we will be able to recruit sufficiently
skilled sales representatives, or that any new sales
representatives will ultimately become productive. If we are
unable to recruit and retain qualified and productive sales
personnel, our ability to commercialize ArteFill and to generate
revenues will be impaired, and our business and financial
prospects will be harmed.
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We have limited manufacturing experience, and if we are
unable to manufacture ArteFill in commercial quantities
successfully and consistently to meet demand, our growth will be
limited. |
Prior to receiving FDA approval, we manufactured ArteFill,
including the PMMA microspheres used in the product, in limited
quantities sufficient only to meet the needs for our clinical
studies. We plan to manufacture ArteFill in commercial
quantities at our facility in San Diego, California. We
currently manufacture the PMMA microspheres used in ArteFill at
our facility in Frankfurt, Germany and intend to implement
redundant capabilities for the production of PMMA microspheres
at our San Diego facility. To be successful, we will need
to manufacture ArteFill in substantial quantities at acceptable
costs. We currently have limited resources and manufacturing
experience and have only manufactured ArteFill in small
quantities. To produce ArteFill in the quantities that we
believe will be required to meet anticipated market demand, we
will need to increase and automate the production process
compared to our current manufacturing capabilities, which will
involve significant challenges and may require additional
regulatory approvals. The development of commercial-scale
manufacturing capabilities will require the investment of
substantial additional funds and hiring and retaining additional
technical personnel who have the necessary manufacturing
experience. For example, we currently use a manual process to
fill syringes with ArteFill and may need to hire additional
personnel for this process in order to meet commercial demand if
we are unable to automate the process as intended. The
implementation of an automated manufacturing process is a
significant manufacturing change that will require development,
validation and documentation, and the preparation and submission
to the FDA of a Prior Approval Supplement to our PMA
application. The FDAs review of a Prior Approval
Supplement typically does not require a facility inspection, but
the FDA will have six months to review the supplement. We may
not successfully complete any required increase or automation of
our manufacturing process in a timely manner or at all. If there
is a disruption to our manufacturing operations at either
facility, we would have no other means of producing ArteFill
until we restore and re-qualify our manufacturing capability at
our facilities or develop alternative manufacturing facilities.
Additionally, any damage to or destruction of our U.S. or
German facilities or our equipment, prolonged power outage or
contamination at either of our facilities would significantly
impair our ability to produce ArteFill. Our lack of manufacturing
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experience may adversely affect the quality of our product when
manufactured in large quantities and therefore result in product
recalls. Any recall could be expensive and generate negative
publicity, which could impair our ability to market ArteFill and
further affect our results of operations. If we are unable to
produce ArteFill in sufficient quantities to meet anticipated
customer demand, our revenues, business and financial prospects
would be harmed. In addition, if our automated production
process is not efficient or does not produce ArteFill in a
manner that meets quality and other standards, our future gross
margins, if any, will be harmed.
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The results provided by ArteFill are highly dependent on
its technique of administration, and the acceptance of ArteFill
will depend on the training, skill and experience of
physicians. |
The administration of ArteFill to patients requires significant
training, skill and experience with the tunneling injection
technique. We intend to provide training to physicians in order
to ensure that they are trained to inject ArteFill using the
tunneling injection technique, and plan to offer ArteFill only
to physicians who have completed our training program. However,
untrained or inexperienced physicians may obtain supplies of
ArteFill from third parties without our authorization and may
perform injections using an improper technique, causing
suboptimal aesthetic results or adverse side effects in
patients. Side effects that may occur as a result of improper
injection technique include:
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swelling or redness; |
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lumpiness at the injection site; and |
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the development of a granuloma, or an inflammatory reaction to a
foreign body that results in redness and hardening of tissue at
the injection site. |
In addition, even physicians who have been trained by us and
have significant experience may administer ArteFill using an
improper technique or in areas of the body where it is not
approved for use by the FDA. This may lead to negative
publicity, regulatory action or product liability claims
regarding ArteFill or our company, which could reduce market
acceptance of ArteFill and harm our business.
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We may experience negative publicity regarding ArteFill or
predecessor products sold outside of the United States,
which may harm our business. |
In the past, predecessor products to ArteFill, such as Artecoll,
have generated or received publicity in news and other media.
ArteFill is a third-generation product that resulted from
product improvements and improvements to the manufacturing
process used to generate these predecessor products. Artecoll
has been manufactured and marketed outside of the United States
under a CE mark by unrelated parties since 1996. Any future
publicity regarding our company, ArteFill or predecessor
products may include coverage that is negative in nature, which
could reduce market acceptance of ArteFill and harm our business
or reputation. Such negative publicity may arise from numerous
events or concerns, including the following:
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concerns about the safety of ArteFill or the predecessor
products; |
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negative side effects, or alleged or perceived negative side
effects, relating to the use of ArteFill or the predecessor
products; |
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concerns about the safety of competing products, such as
temporary muscle paralytics or temporary dermal fillers, or
aesthetic treatments generally; |
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negative side effects, or alleged or perceived negative side
effects, relating to the use of these competing products; |
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any product recalls relating to ArteFill or competing products; |
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negative side effects or safety issues resulting from any
off-label use of ArteFill; |
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administration of ArteFill by unlicensed or untrained
individuals; and |
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any lawsuits or administrative actions that we or our officers
or directors may be party to or involved in. |
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Any negative publicity regarding ArteFill, its predecessor
products or our company could impair our ability to generate
revenues from the sale of ArteFill and harm our business and
financial prospects.
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Sales of ArteFill could be harmed due to patients
allergic reactions to the bovine collagen component of ArteFill,
the need to test for such allergic reactions before treatment
with ArteFill or patients reluctance to use animal-based
products. |
ArteFill contains bovine collagen. Although the bovine collagen
that we use is purified, patients can experience an allergic
reaction. Accordingly, the instructions for use that accompany
ArteFill require that all patients must be tested for any such
allergies at least 28 days prior to treatment with
ArteFill. If patients test positive for allergic reactions to
the bovine collagen at higher rates than we expect, sales of
ArteFill will be lower than anticipated. The need for a skin
test in advance of treatment with ArteFill also may render
ArteFill less attractive to patients who seek an immediate
aesthetic treatment. The
28-day interval between
testing and treatment may also result in the loss of some
potential patients who, regardless of test results, fail to
reappear for treatment after administration of the skin test. In
addition, some potential patients may have reservations
regarding the use of animal-based products. As a result of these
factors, physicians may recommend alternative aesthetic
treatments over ArteFill, which would limit or reduce our sales
and harm our ability to generate revenues.
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Our ability to manufacture and sell ArteFill could be
harmed if we experience problems with the supply of calf hides
from the closed herd of domestic cattle from which we derive the
bovine collagen component of ArteFill. |
We derive the bovine collagen component of ArteFill from calf
hides supplied through a herd that is isolated, bred and
monitored in accordance with both FDA and United States
Department of Agriculture, or USDA, guidelines to minimize the
risk of contamination from bovine spongiform encephalopathy, or
BSE, commonly referred to as mad cow disease. BSE is a chronic,
degenerative disorder that affects the central nervous system.
We currently rely on a sole domestic supplier, Lampire
Biological Labs, Inc., for the calf hides from which we produce
the purified bovine collagen used in ArteFill. If this herd were
to suffer a significant reduction or become unavailable to us
through disease, natural disaster or otherwise for a prolonged
period, we would have a limited ability to access a supply of
acceptable calf hides from a similarly segregated source. In
addition, if there were to be any widespread discovery of BSE in
the United States, our ability to access bovine collagen may be
impaired even if our herd is unaffected by the disease, if third
parties begin to demand calf hides from our herd. Although we
have not experienced any problems with our supply of calf hides
in the past, a significant reduction in the supply of acceptable
calf hides due to contamination of our suppliers herd, a
supply shortage or interruption, or an increase in demand beyond
our current suppliers capabilities could harm our ability
to produce and sell ArteFill until a new source of supply is
identified, established and qualified with the FDA. Any delays
or disruptions in the supply of calf hides would negatively
affect our revenues. We currently have an 18 months
supply of calf hides in stock and intend to establish and
maintain a supply of calf hides that will last for more than two
years. If our stockpiled supply is damaged or contaminated, and
we are unable to obtain acceptable calf hides in the time frames
desired, or at all, our business and results of operations will
be harmed.
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ArteFill is not yet supported by long-term clinical data
and may therefore prove to be less effective than initially
thought. |
We currently lack published long-term clinical data for
completed trials supporting the aesthetic benefits of ArteFill
beyond six months. We are currently conducting ongoing,
five-year follow-up
evaluations of patients who received ArteFill in our
U.S. clinical trial and who qualify for long-term
follow-up. When completed, we intend to submit the results of
these five-year
follow-up evaluations
to the FDA and to a peer-reviewed scientific journal for
publication. Dr. Steven Cohen, the lead investigator in our
U.S. clinical trial, presented the preliminary findings of
the five-year follow-up
study, which included the results of evaluations for
69 patients, at a conference of the American Society of
Plastic Surgeons held in San Francisco, California in October
2006. The interim data for the 69 patients have also been
published in the September 1, 2006 supplement to
Plastic
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and Reconstructive Surgery, a peer-reviewed journal.
There can be no assurance that we will be successful in
obtaining FDA approval to claim that the aesthetic benefits of
ArteFill extend beyond six months.
In addition, without published peer-reviewed data for completed
trials regarding the safety and efficacy of ArteFill beyond six
months, physicians may be slow to adopt ArteFill. Further,
future studies of patients injected with ArteFill may indicate
that the aesthetic benefits of ArteFill do not meet the
expectations of physicians or patients. Such data would slow
market acceptance of ArteFill, significantly reduce our ability
to achieve expected revenues and could prevent us from becoming
profitable.
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We have increased the size of our company significantly in
connection with the commercial launch of ArteFill, and
difficulties managing our growth could adversely affect our
business, operating results and financial condition. |
We have hired a substantial number of additional personnel in
connection with the commercial launch of ArteFill, and such
growth has and could continue to place a strain on our
management and our administrative, operational and financial
infrastructure. From January 1, 2005 to November 27,
2006, we have increased the size of our company from 12 to 109
employees. Based on our current operating plan, we expect to
incur costs of approximately $8.0 million to
$12.0 million over a 12-month period in connection with
establishing and building our internal sales force and sales
management to market ArteFill. Thereafter, we will hire
additional sales and manufacturing personnel as necessary to
meet customer demand for ArteFill. Our ability to manage our
operations and growth requires the continued improvement of
operational, financial and management controls, reporting
systems and procedures, particularly to meet the reporting
requirements of the Securities Exchange Act of 1934 after we
become subject to those requirements. If we are unable to manage
our growth effectively or if we are unable to attract additional
highly qualified personnel, our business, operating results and
financial condition may be harmed.
Under the label approved by the FDA, we are limited to
marketing and advertising ArteFill for the treatment of
nasolabial folds with efficacy benefits of six months.
Our U.S. clinical trial demonstrated the efficacy of
ArteFill for the treatment of nasolabial folds, or smile lines,
at primary efficacy endpoints of up to six months by comparison
to the control products. As a result, the FDA requires us to
label, advertise and promote ArteFill only for the
treatment of nasolabial folds with an efficacy of six months.
This limitation restricts our ability to market or advertise
ArteFill and could negatively affect our growth. If we wish to
market and promote ArteFill for other indications or claim
efficacy benefits beyond six months, we would have to conduct
further clinical trials or studies to gather clinical
information for the FDA, which would be costly and take a number
of years. Even if we submitted additional clinical data to the
FDA to support other PMA applications or additional follow-up
study data to support extended efficacy claims, there can be no
assurance that we would be successful in obtaining approval to
market ArteFill for other indications or to claim efficacy
benefits beyond six months. In addition, we will not be
permitted to market, advertise or promote ArteFill for
off-label uses, which are uses that the FDA has not approved.
Off-label use of ArteFill may occur in areas such as the
treatment of other facial wrinkles, creases and other soft
tissue defects. While off-label uses of aesthetic products are
common and the FDA does not regulate physicians choice of
treatments, the FDA does restrict a manufacturers
communications regarding such
off-label use. As a
result, we may not actively promote or advertise ArteFill for
off-label uses, even if physicians use ArteFill to treat such
conditions. This limitation will restrict our ability to market
our product and may substantially limit our sales. The
U.S. Attorneys offices and other regulators, in
addition to the FDA, have recently focused substantial attention
on off-label promotional activities and, in certain cases, have
initiated civil and criminal investigations and actions related
to such practices. If we are found to have promoted
off-label uses of
ArteFill in violation of the FDAs marketing approval
requirements, we could face warning letters, significant adverse
publicity, fines, legal proceedings, injunctions or other
penalties, any of which would be harmful to our business.
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If changes in the economy and consumer spending reduce
demand for ArteFill, our sales and profitability could
suffer. |
We intend to position ArteFill as a premium-priced product in
the injectable aesthetic product market. Treatment with ArteFill
will be an elective procedure, directly paid for by patients
without reimbursement. As a result, sales of ArteFill will
require that patients have sufficient disposable income to spend
on an elective aesthetic treatment. Adverse changes in the
economy may cause consumers to reassess their spending choices
and choose less expensive alternative treatments over ArteFill,
or may reduce the demand for elective aesthetic procedures in
general. A shift of this nature could impair our ability to
generate sales and could harm our business, financial condition
and results of operations.
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We are dependent on our key management personnel. The loss
of any of these individuals could harm our business. |
We are dependent on the efforts of our current key management,
including Christopher J. Reinhard, our Executive Chairman of the
Board of Directors, Diane S. Goostree, our President and Chief
Executive Officer and Peter C. Wulff, our Chief Financial
Officer. We are a party to an employment offer letter agreement
with Ms. Goostree. In addition, we have entered into
employment agreements with Russell Anderson, our Vice
President Product Development and Engineering and
Lawrence Braga, our Vice President Manufacturing. We
may terminate our relationships with Ms. Goostree and
Messrs. Anderson and Braga at any time, with or without
cause. Under each of their agreements, if employment is
terminated by us other than for good cause or under certain
other circumstances, including a change of control with respect
to our company, the executive is entitled to receive, among
other things, severance compensation equal to nine months of her
then-current base salary, payable in a lump sum, in the case of
Ms. Goostree, and three months salary continuation
payments at their then-current base salary, in the case of
Messrs. Anderson and Braga. All of our other officers and
employees are employed at will. Although we are not aware of any
present intention of these persons to leave our company, any of
our key management personnel or other employees may elect to end
their employment with us and pursue other opportunities at any
time. We do not have and have no present intention to obtain key
man life insurance on any of our executive officers or key
management personnel to mitigate the impact of the loss of any
of these individuals. The loss of any of these individuals, or
our inability to recruit and train additional key personnel,
particularly senior sales and marketing and research and
development employees, in a timely manner, could harm our
business and our future product revenues and prospects. The
market for skilled employees for medical technology and
biotechnology companies in San Diego is competitive, and we
can provide no assurance that we will be able to locate skilled
and qualified employees to replace any of our employees that
choose to depart. If we are unable to attract and retain
qualified personnel, our business will be significantly harmed.
Legal proceedings with our former officers and employees
could be costly and could divert our management teams
attention from our business and operations.
On November 6, 2006, we filed a demand for arbitration with
the American Arbitration Association against Melvin Ehrlich, who
served as our President and Chief Operating Officer from
January 15, 2004 through April 5, 2004. In the
arbitration, we are seeking declaratory relief regarding the
number of shares of common stock Mr. Ehrlich is entitled to
purchase under a warrant we issued to him in connection with his
employment agreement. We believe Mr. Ehrlich vested in and,
therefore, is entitled to purchase 26,070 shares of common
stock based on the length of time he provided services to our
company. These warrant shares have an exercise price of $4.25
per share and are subject to a 180-day market standoff period in
connection with our proposed offering. Mr. Ehrlich contends
that he is entitled to purchase up to 470,588 shares of
common stock, at an average exercise price of $7.44 per share,
contingent upon our satisfaction of certain milestones,
including the FDAs approval of ArteFill, the FDAs
certification of our manufacturing facilities and the completion
of this offering. He claims that the language in the warrant
allows him to continue to vest in the warrant shares after his
employment with us ended, regardless of whether he provided any
assistance to us to satisfy the milestones set forth in the
warrant. We reject this interpretation
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of the warrant and plan to pursue our request for declaratory
relief vigorously and to defend against any claims
Mr. Ehrlich asserts.
Following discussions at a series of weekly board meetings in
October 2006, our board approved a plan on October 26, 2006
to reduce our operating costs and to reorganize our business
operations, including our sales and marketing organization, to
focus our efforts on the U.S. market and on physician-based
training and sales programs. In connection with this cost
reduction plan and reorganization, we terminated the employment
of William von Brendel, our former Vice President of Worldwide
Sales and International Markets, Harald T. Schreiber, our former
Chief Creative Officer, and a manager in our sales and marketing
organization on October 27, 2006. In connection with their
termination, we believe we have paid all amounts owed to
Messrs. von Brendel and Schreiber under the terms of
their employment agreements. On the date of their termination,
we also offered to pay Messrs. von Brendel and Schreiber three
months severance and to extend the expiration date of
their respective stock options from 90 days to one year
after the date of termination of their employment, in exchange
for their execution of a general release.
On November 2, 2006, we were served with a demand for
arbitration with the American Arbitration Association by
Mr. Schreiber pursuant to the dispute resolution provisions
in his employment agreement. Mr. Schreiber seeks
compensatory damages of an unspecified amount and alleges
several causes of action, including wrongful termination, fraud,
breach of contract and the implied covenant of good faith and
fair dealing, and hostile work environment. We believe that many
of Mr. Schreibers claims contradict the terms of his
employment agreement, and we deny his allegations. To avoid the
costs of arbitration, we have issued a settlement offer to
Mr. Schreiber. There can be no assurance that our offer
will be acceptable to Mr. Schreiber, or that we will reach
a settlement with Mr. Schreiber. If we do not reach an
agreement with Mr. Schreiber, we will defend the case
vigorously.
On November 16, 2006, we were served with a demand for
arbitration with the American Arbitration Association by
Mr. von Brendel pursuant to the dispute resolution
provisions in his employment agreement. Mr. von Brendel seeks
compensatory damages of an unspecified amount and alleges
various causes of action, including wrongful termination and
breach of contract, fraud and the implied covenant of good faith
and fair dealing. We deny Mr. von Brendels allegations and
believe that many of his claims contradict the terms of his
employment agreement. To avoid the costs of arbitration, we have
issued a settlement offer to Mr. von Brendel. There can be no
assurance that our offer will be acceptable to Mr. von Brendel,
or that we will reach an agreement with Mr. von Brendel. If we
do not reach an agreement with Mr. von Brendel, we will defend
the case vigorously.
We maintain employment practices liability insurance in an
amount of up to $2.0 million in the aggregate for claims
made during any one-year insurance period. Our insurance carrier
has agreed to provide coverage and defense for these actions,
subject to customary reservation of rights. We cannot assure you
that our insurance carrier will provide coverage for all
outstanding claims, or any employment-related claims asserted in
the future based on our recent management changes, or that any
coverage will be adequate to cover these claims. In addition,
regardless of merit or eventual outcome, our existing actions,
and any potential actions resulting from our recent management
changes, may result in the expenditure of a significant amount
of cash on legal fees, expenses, payment of settlements or
damages. Further, these actions may divert our management
teams time and attention from our business and operations.
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We may rely on third parties for our international sales,
marketing and distribution activities. |
Although we plan initially to market and sell ArteFill to
physicians in the United States through our own sales force, we
may in the future rely on third parties to assist us in sales,
marketing and distribution, particularly in international
markets. If and when our dependence on third parties for our
international sales, marketing and distribution activities
increases, we will be subject to a number of risks associated
with our dependence on these third parties, including:
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lack of day-to-day
control over the activities of third-party contractors; |
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third-party contractors may not fulfill their obligations to us
or otherwise meet our expectations; |
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third-party contractors may terminate their arrangements with us
on limited or no notice or may change the terms of these
arrangements in a manner unfavorable to us for reasons outside
of our control; and |
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disagreements with our contractors could require or result in
costly and time-consuming litigation or arbitration. |
If we fail to establish and maintain satisfactory relationships
with these third-party contractors, our revenues and market
share may not grow as anticipated, and we could be subject to
unexpected costs which would harm our results of operations and
financial condition.
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To the extent we engage in marketing and distribution
activities outside the United States, we will be exposed to
risks associated with exchange rate fluctuations, trade
restrictions and political, economic and social
instability. |
If ArteFill is approved for sale in foreign markets and we begin
marketing ArteFill in these markets, we will be subject to
various risks associated with conducting business abroad. A
foreign government may require us to obtain export licenses or
may impose trade barriers or tariffs that could limit our
ability to build our international presence. Our operations in
some markets also may be adversely affected by political,
economic and social instability in foreign countries, including
terrorism. To the extent that we attempt to expand our sales
efforts in international markets, we may also face difficulties
in staffing and managing foreign operations, longer payment
cycles and problems with collecting accounts receivable and
increased risks of piracy and limits on our ability to enforce
our intellectual property rights. In addition, for financial
reporting purposes, results of operations of our foreign
subsidiary will be translated from local currency into
U.S. dollars based on average monthly exchange rates. We
currently do not hedge our foreign currency transactions and
therefore will be subject to the risk of changes in exchange
rates. If we are unable to adequately address the risks of doing
business abroad and build an international presence, our
business, financial condition and results of operations may be
harmed.
If we acquire any companies or technologies, our business
may be disrupted and the attention of our management may be
diverted.
In July 2004, we acquired assets and intellectual property from
FormMed Biomedicals AG in connection with the establishment of
our manufacturing facility in Germany. This transaction had an
effective date as of January 1, 2004. Since the completion
of this acquisition, we have spent approximately $750,000 to
improve and upgrade the physical facilities, manufacturing
processes and quality control systems at that facility to be in
compliance with both U.S. and international regulatory quality
requirements. We may make additional acquisitions of
complementary companies, products or technologies in the future.
Any acquisitions will require the assimilation of the
operations, products and personnel of the acquired businesses
and the training and motivation of these individuals.
Acquisitions may disrupt our operations and divert
managements attention from
day-to-day operations,
which could impair our relationships with current employees,
customers and strategic partners. We may need to incur debt or
issue equity securities to pay for any future acquisitions. The
issuance of equity securities for an acquisition could be
substantially dilutive to our stockholders. In addition, our
profitability may suffer because of acquisition-related costs or
amortization or impairment costs for acquired goodwill and other
intangible assets. We may not realize the intended benefits of
any acquisitions if management is unable to fully integrate
acquired businesses, products, technologies or personnel with
existing operations. We are currently not party to any
agreements, written or oral, for the acquisition of any company,
product or technology, nor do we anticipate making any
arrangements for any such acquisition in the foreseeable future.
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Our business, which depends on a small number of
facilities, is vulnerable to natural disasters,
telecommunication and information systems failures, terrorism
and similar problems, and we are not fully insured for losses
caused by such incidents. |
We conduct operations in two facilities located in
San Diego, California and Frankfurt, Germany. These
facilities could be damaged by earthquake, fire, floods, power
loss, telecommunication and information systems failures or
similar events. Our insurance policies have limited coverage
levels of up to approximately $9.1 million for property
damage and up to $5.0 million for business interruption in
these events and may not adequately compensate us for any losses
that may occur. We currently pay annual premiums totaling
approximately $40,000 for this coverage. In addition, terrorist
acts or acts of war may cause harm to our employees or damage
our facilities. Further, the potential for future terrorist
attacks, the national and international responses to terrorist
attacks or perceived threats to national security, and other
acts of war or hostility have created many economic and
political uncertainties that could adversely affect our business
and results of operations in ways that we cannot predict. We are
uninsured for these types of losses.
We are recording non-cash compensation expense that may
result in an increase in our net losses for a given
period.
Deferred stock-based compensation represents an expense
associated with the recognition of the difference between the
deemed fair value of common stock at the time of a stock option
grant or issuance and the option exercise price or price paid
for the stock. Deferred stock-based compensation is amortized
over the vesting period of the option or issuance. At
December 31, 2005, deferred stock-based compensation
related to option grants and stock issuances totaled
approximately $2.7 million. Effective January 1, 2006,
we prospectively adopted Statement of Financial Accounting
Standards (SFAS) No. 123R, Share-Based Payment (SFAS
No. 123(R)). SFAS No. 123(R) required us to reclassify
the $2.7 million of deferred stock-based compensation to
additional paid-in capital. The $2.7 million will be
expensed on a straight-line basis as the options or stock vest,
generally over a period of four years. We also record non-cash
compensation expense for equity stock-based instruments issued
to non-employees. SFAS No. 123(R) now requires us to record
stock-based compensation expense for equity instruments granted
to employees and directors. In June 2006, we offered certain
holders of warrants that were issued in exchange for services an
opportunity to amend their warrants to eliminate the automatic
expiration upon the closing date of our initial public offering
if not exercised prior, and to allow the warrants to continue in
effect under their existing terms until March 2007. In
June 2006, we also offered certain holders of warrants that
were issued in connection with our prior bridge loan financings
an opportunity to amend their warrants to eliminate the
automatic expiration upon the closing date of our public
offering if not exercised prior, and to allow the warrants to
continue in effect under the terms of the original warrants. The
warrant holders were given the option to amend their warrants
until June 23, 2006. Based on the preferences of our
warrant holders, we recorded a warrant modification expense of
$1,376,000 during the nine months ended September 30, 2006.
Of the warrant modification expense of $1,376,000, $477,000 was
recorded as interest expense because these original warrants
were issued in connection with financings. The remaining
$899,000 was recorded as consulting expense, comprised of
$66,000 in research and development expense and $833,000 in
selling, general and administrative expense because these
original warrants were issued in exchange for services. As a
result of these amendments, warrants to purchase approximately
2,490,189 shares of common stock will be outstanding after
completion of our initial public offering. The impact of these
amendments was being charged to expense as of the modification
date, as there is no implicit service period associated with the
warrants, and no bridge loans remain outstanding. Non-cash
compensation expense associated with future equity compensation
awards may result in an increase in our net loss, and adversely
affect our reported results of operations.
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Changes in, or interpretations of, accounting rules and
regulations, such as expensing of stock options, could result in
unfavorable accounting charges or require us to change our
compensation policies. |
Accounting methods and policies for public companies, including
policies governing revenue recognition, expenses, accounting for
stock options and in-process research and development costs, are
subject to further review, interpretation and guidance from
relevant accounting authorities, including the SEC. Changes to,
or
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interpretations of, accounting methods or policies in the future
may require us to reclassify, restate or otherwise change or
revise our financial statements, including those contained in
this prospectus. For example, the Financial Accounting Standards
Board has adopted a new accounting pronouncement requiring the
recording of expense for the fair value of stock options
granted. The impact of the adoption of SFAS No. 123(R)
for stock options granted to employees and directors from
January 1, 2006 through September 30, 2006 was
$8,763,600. This amount will be charged to expense over the
requisite service period, which is generally four years, on a
straight-line basis. The amount charged to expense related to
the adoption of SFAS No. 123(R) during the nine months
ended September 30, 2006 was $749,000. We rely heavily on
stock options to motivate current employees and to attract new
employees. As a result of the requirement to expense stock
options, we may choose to reduce our reliance on stock options
as a motivation tool. If we reduce our use of stock options, it
may be more difficult for us to attract and retain qualified
employees. However, if we do not reduce our reliance on stock
options, our reported net losses may increase, which may have an
adverse effect on our reported results of operations.
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Impairment of our significant intangible assets may reduce
our profitability. |
The costs of our acquired patents and technology are recorded as
intangible assets and amortized over the period that we expect
to benefit from the assets. As of September 30, 2006, the
net acquired intangible assets comprised approximately 13.0% of
our total assets. We periodically evaluate the recoverability
and the amortization period of our intangible assets. Some
factors we consider important in assessing whether or not
impairment exists include performance relative to expected
historical or projected future operating results, significant
changes in the manner of our use of the assets or the strategy
for our overall business, and significant negative industry or
economic trends. These factors, assumptions, and changes therein
could result in an impairment of our long-lived assets. Any
impairment of our intangible assets may reduce our profitability
and harm our results of operations and financial condition.
Risks Related to Our Intellectual Property
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Our ability to achieve commercial success will depend in
part on obtaining and maintaining patent protection and trade
secret protection relating to ArteFill and our technology and
future products, as well as successfully defending our patents
against third party challenges. If we are unable to obtain and
maintain protection for our intellectual property and
proprietary technology, the value of ArteFill, our technology
and future products will be adversely affected, and we will not
be able to protect our technology from unauthorized use by third
parties. |
Our long-term success largely depends on our ability to maintain
patent protection covering our product, ArteFill, and to obtain
patent and intellectual property protection for any future
products that we may develop and seek to market. In order to
protect our competitive position for ArteFill and any future
products, we must:
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prevent others from successfully challenging the validity or
enforceability of, or infringing, our issued patents and our
other proprietary rights; |
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operate our business, including the manufacture, sale and use of
ArteFill and any future products, without infringing upon the
proprietary rights of others; |
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successfully enforce our patent rights against third parties
when necessary and appropriate; and |
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obtain and protect commercially valuable patents or the rights
to patents both domestically and abroad. |
We currently have one U.S. patent and corresponding patents
in 14 international jurisdictions that cover our product,
ArteFill, and alloplastic implants, which are implants
containing inert materials that are compatible for use in or
around human tissue, made of smooth, round, injectable polymeric
and non-polymeric microspheres, which can be used for soft
tissue augmentation. The U.S. patent covering this
invention, U.S. Patent No. 5,344,452, will expire in
September 2011. Although we applied for an extension of the term
of this patent until 2016, we cannot assure you that the
U.S. Patent and Trademark Office, or the U.S. PTO,
will grant the extension for the full five years or at all. In
addition, our competitors or other patent
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holders may challenge the validity of our patents or assert that
our products and the methods we employ are covered by their
patents. If the validity or enforceability of any of our patents
is challenged, or others assert their patent rights against us,
we may incur significant expenses in defending against such
actions, and if any such challenge is successful, our ability to
sell ArteFill may be harmed.
Protection of intellectual property in the markets in which we
compete is highly uncertain and involves complex legal and
scientific questions. It may be difficult to obtain additional
patents relating to our products or technology. Furthermore, any
changes in, or unexpected interpretations of, the patent laws
may adversely affect our ability to enforce our patent position.
Other risks and uncertainties that we face with respect to our
patents and other proprietary rights include the following:
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our issued patents may not be valid or enforceable or may not
provide adequate coverage for our products; |
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the claims of any issued patents may not provide meaningful
protection; |
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our issued patents may expire before we are able to successfully
commercialize ArteFill or any future product candidates or
before we receive sufficient revenues in return; |
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patents issued to us may be successfully challenged,
circumvented, invalidated or rendered unenforceable by third
parties; |
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the patents issued or licensed to us may not provide a
competitive advantage; |
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patents issued to other companies, universities or research
institutions may harm our ability to do business; |
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other companies, universities or research institutions may
independently develop similar or alternative technologies or
duplicate our technologies and commercialize discoveries that we
attempt to patent; |
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other companies, universities or research institutions may
design around technologies we have licensed, patented or
developed; |
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because the information contained in patent applications is
generally not publicly available until published (usually
18 months after filing), we cannot assure you that we have
been the first to file patent applications for our inventions or
similar technology; |
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the future and pending applications we will file or have filed,
or to which we will or do have exclusive rights, may not result
in issued patents or may take longer than we expect to result in
issued patents; and |
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we may be unable to develop additional proprietary technologies
that are patentable. |
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Our other intellectual property, particularly our trade
secrets and know-how, are important to us, and our inability to
safeguard it may adversely affect our business by causing us to
lose a competitive advantage or by forcing us to engage in
costly and time-consuming litigation to defend or enforce our
rights. |
We rely on trademarks, copyrights, trade secret protections,
know-how and contractual safeguards to protect our non-patented
intellectual property, including our manufacturing processes.
Our employees, consultants and advisors are required to enter
into confidentiality agreements that prohibit the disclosure or
use of our confidential information. We also have entered into
confidentiality agreements to protect our confidential
information delivered to third parties for research and other
purposes. There can be no assurance that we will be able to
effectively enforce these agreements or that the subject
confidential information will not be disclosed, that others will
not independently develop substantially equivalent confidential
information and techniques or otherwise gain access to our
confidential information or that we can meaningfully protect our
confidential information. Costly and time-consuming litigation
could be necessary to enforce and determine the scope of our
confidential information, and failure to maintain the
confidentiality of our
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confidential information could adversely affect our business by
causing us to lose a competitive advantage maintained through
such confidential information.
Disputes may arise in the future with respect to the ownership
of rights to any technology developed with consultants, advisors
or collaborators. These and other possible disagreements could
lead to delays in the collaborative research, development or
commercialization of our products, or could require or result in
costly and time-consuming litigation that may not be decided in
our favor. Any such event could have a material adverse effect
on our business, financial condition and results of operations
by delaying or preventing our ability to commercialize
innovations or by diverting our resources away from
revenue-generating projects.
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Pursuant to the terms of an intellectual property
litigation settlement, we have licensed some of our technology
to a competitor. |
In October 2005, we and Dr. Martin Lemperle, the brother of
Dr. Stefan M. Lemperle, our former Chief Executive Officer
and a former director, entered into a settlement and license
agreement with BioForm Medical, Inc. and BioForm Medical Europe
B.V., or the BioForm entities, pursuant to which all outstanding
disputes and litigation matters among the parties were settled.
In connection with the settlement, we granted to the BioForm
entities, which are competitors of us, an exclusive, world-wide,
royalty-bearing license under certain of our patents to make and
sell implant products containing calcium hydroxylapatite, or
CaHA, particles and a non-exclusive, world-wide, royalty-bearing
license under the same patents to make and sell certain other
non-polymeric implant products. These license grants allow
BioForm to market and sell its Radiesse and
Coaptite®
products and other potential future products. While these
products are currently approved only for vocal cord
augmentation, radiographic tissue marking and the treatment of
oral and maxillofacial defects in the United States, we believe
that Radiesse is under review by the FDA for the treatment of
facial wrinkles and is available for such use outside the United
States. If BioForm obtains FDA approval to develop, market and
sell Radiesse, Coaptite or any other CaHA implant product for
indications similar to ArteFill, our ability to generate
revenues from sales of ArteFill may be impaired. In addition, if
we become involved in litigation or if third parties infringe or
threaten to infringe our intellectual property rights in the
future, we may choose to make further license grants with
respect to our technology, which could further harm our ability
to market and sell ArteFill.
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Our business may be harmed, and we may incur substantial
costs as a result of litigation or other proceedings relating to
patent and other intellectual property rights. |
A third party may assert that we (including our subsidiary) have
infringed, or one of our distributors or strategic collaborators
has infringed, his, her or its patents and proprietary rights or
challenge the validity or enforceability of our patents and
proprietary rights. Our competitors, many of which have
substantially greater resources than us and have made
significant investments in competing technologies or products,
may seek to apply for and obtain patents that will prevent,
limit or interfere with our ability to make, use and sell future
products either in the United States or in international
markets. Further, we may not be aware of all of the patents and
other intellectual property rights owned by third parties that
may be potentially adverse to our interests. Intellectual
property litigation in the medical device and biotechnology
industries is common, and we expect this trend to continue. We
may need to resort to litigation to enforce our patent rights or
to determine the scope and validity of a third partys
patents or other proprietary rights. The outcome of any such
proceedings is uncertain and, if unfavorable, could
significantly harm our business. If we do not prevail in this
type of litigation, we or our distributors or strategic
collaborators may be required to:
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pay actual monetary damages, royalties, lost profits and/or
increased damages and the third partys attorneys
fees, which may be substantial; |
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expend significant time and resources to modify or redesign the
affected products or procedures so that they do not infringe a
third partys patents or other intellectual property
rights; further, there can be no assurance that we will be
successful in modifying or redesigning the affected products or
procedures; |
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obtain a license in order to continue manufacturing or marketing
the affected products or services, and pay license fees and
royalties; if we are able to obtain such a license, it may be
non-exclusive, giving |
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our competitors access to the same intellectual property, or the
patent owner may require that we grant a cross-license to our
patented technology; or |
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stop the development, manufacture, use, marketing or sale of the
affected products through a
court-ordered sanction
called an injunction, if a license is not available on
acceptable terms, or not available at all, or our attempts to
redesign the affected products are unsuccessful. |
Any of these events could adversely affect our business strategy
and the value of our business. In addition, the defense and
prosecution of intellectual property suits, interferences,
oppositions and related legal and administrative proceedings in
the United States and elsewhere, even if resolved in our favor,
could be expensive, time consuming, generate negative publicity
and could divert financial and managerial resources. Some of our
competitors may be able to sustain the costs of complex
intellectual property litigation more effectively than we can
because they have substantially greater financial resources.
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Our ability to market ArteFill in some foreign countries
may be impaired by the activities and intellectual property
rights of third parties. |
Although we acquired all of the international intellectual
property rights related to Artecoll and the ArteFill technology
platform in 2004, we are aware that third parties located in
Germany and the Netherlands have in the past, and may be
currently, manufacturing and selling products for the treatment
of facial wrinkles under the name Artecoll outside the United
States. Following the establishment of ArteFill in the United
States, we plan to explore opportunities to market and sell
ArteFill in select international markets. To successfully enter
into these markets and achieve desired revenues internationally,
we may need to enforce our patent and trademark rights against
third parties that we believe may be infringing on our rights.
The laws of some foreign countries do not protect intellectual
property, including patents, to as great an extent as do the
laws of the United States. Policing unauthorized use of our
intellectual property is difficult, and there is a risk that
despite the expenditure of significant financial resources and
the diversion of management attention, any measures that we take
to protect our intellectual property may prove inadequate in
these countries. Our competitors in these countries may
independently develop similar technology or duplicate our
products, thus likely reducing our sales in these countries.
Furthermore, some of our patent rights may be limited in
enforceability to the United States or certain other select
countries, which may limit our intellectual property rights
abroad.
Risks Related to Government Regulation
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ArteFill will be subject to ongoing regulatory review, and
if we fail to comply with continuing U.S. and foreign
regulations, ArteFill could be subject to a product recall or
other regulatory action, which would seriously harm our
business. |
Even though the FDA has approved the commercialization of
ArteFill in the United States, the manufacturing, labeling,
packaging, adverse event reporting, storage, advertising,
promotion and record-keeping related to ArteFill continue to be
subject to extensive ongoing regulatory requirements. We are
subject to ongoing FDA requirements for submission of safety and
other post-market information and reports, including results
from any post-marketing studies or vigilance required as a
condition of approval. In particular, the FDA has required us to
monitor the stability of the bovine collagen manufactured at our
U.S. facility for sufficient time to support an 18-month
expiration date, and to conduct a post-market study of 1,000
patients to examine the significance of delayed granuloma
formation for a period of five years after their initial
treatment. The FDA and similar governmental authorities in other
countries have the authority to require the recall of ArteFill
in the event of material deficiencies or defects in design,
manufacture or labeling. Any recall of ArteFill would divert
managerial and financial resources and harm our reputation among
physicians and patients.
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Additionally, in connection with the ongoing regulation of
ArteFill, the FDA or other regulatory authorities may also:
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impose labeling and advertising requirements, restrictions or
limitations, including the inclusion of warnings, precautions,
contraindications or use limitations that could have a material
impact on the future profitability of our product candidates; |
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impose testing and surveillance to monitor our products and
their continued compliance with regulatory requirements; and |
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require us to submit products for inspection. |
Any manufacturer and manufacturing facilities we use to make our
products will also be subject to periodic unannounced review and
inspection by the FDA. If a previously unknown problem or
problems with a product or a manufacturing and laboratory
facility used by us is discovered, the FDA or foreign regulatory
agency may impose restrictions on that product or on the
manufacturing facility, including requiring us to withdraw the
product from the market. Material changes to an approved
product, including the way it is manufactured or promoted,
require FDA approval before the product, as modified, can be
marketed. If we fail to comply with applicable regulatory
requirements, a regulatory agency may:
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issue warning letters; |
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impose fines and other civil or criminal penalties; |
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suspend or withdraw regulatory approvals for our products; |
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refuse to approve pending applications or supplements to
approved applications filed by us; |
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delay, suspend or otherwise restrict our manufacturing,
distribution, sales and marketing activities; |
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close our manufacturing facilities; or |
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seize or detain products or require a product recall. |
If any of these events were to occur, we would have limited or
no ability to market and sell ArteFill, and our business would
be seriously harmed.
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If we, or the supplier of the calf hides used in our
collagen, do not comply with FDA and other federal regulations,
our supply of product could be disrupted or terminated. |
We must comply with various federal regulations, including the
FDAs Quality System Regulations, or QSRs, applicable to
the design and manufacturing processes related to medical
devices. In addition, Lampire Biological Labs, Inc., the
supplier of the calf hides used in our collagen, also must
comply with manufacturing and quality requirements imposed by
the FDA and the USDA. If we or our supplier fail to meet or are
found to be noncompliant with QSRs or any other requirements of
the FDA or USDA, or similar regulatory requirements outside of
the United States, obtaining the required regulatory approvals,
including from the FDA, to use alternative suppliers or
manufacturers may be a lengthy and uncertain process. A lengthy
interruption in the manufacturing of one or more of our products
as a result of non-compliance could adversely affect our product
inventories and supply of products available for sale which
could reduce our sales, margins and market share, as well as
harm our overall business and financial results.
The discovery of previously unknown problems with ArteFill may
result in restrictions on the product, including withdrawal from
manufacture. In addition, the FDA may revisit and change its
prior determinations with regard to the safety or efficacy of
ArteFill or our future products. If the FDAs position
changes, we may be required to change our labeling or cease to
manufacture and market our products. Even prior to any formal
regulatory action, we could voluntarily decide to cease the
distribution and sale of, or to recall ArteFill if concerns
about its safety or efficacy develop. In their regulation of
advertising, the FDA and the Federal Trade Commission, or FTC,
may issue correspondence alleging that our advertising or
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promotional practices are false, misleading or deceptive. The
FDA and the FTC may impose a wide array of sanctions on
companies for such advertising practices, which could result in
any of the following:
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incurring substantial expenses, including fines, penalties,
legal fees and costs to comply with applicable regulations; |
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changes in the methods of marketing and selling products; |
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taking FDA-mandated corrective action, which may include placing
advertisements or sending letters to physicians rescinding or
correcting previous advertisements or promotions; or |
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disruption in the distribution of products and loss of sales
until compliance with the FDAs position is obtained. |
If any of the above sanctions are imposed on us, it could damage
our reputation, and harm our business and financial condition.
In addition, physicians may utilize ArteFill for uses that are
not described in the products labeling or differ from
those tested by us and approved by the FDA. While such
off-label uses are common and the FDA does not
regulate physicians choice of treatments, the FDA does
restrict a manufacturers communications on the subject of
off-label use. Companies cannot promote FDA-approved
products for off-label uses, but under certain limited
circumstances they may disseminate to practitioners articles
published in peer-reviewed journals. To the extent allowed by
law, we intend to distribute peer-reviewed articles on ArteFill
and any future products to practitioners. If, however, our
activities fail to comply with the FDAs regulations or
guidelines, we may be subject to warnings from, or enforcement
action by, the FDA.
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We have a manufacturing facility in Frankfurt, Germany,
and will be subject to a variety of regulations in jurisdictions
outside the United States that could have a material adverse
effect on our business in a particular market or in
general. |
We presently manufacture the PMMA microspheres used in ArteFill
at our manufacturing facility in Germany. In addition, we intend
to expand our operations and market ArteFill in other foreign
markets, including Canada and selected countries in Europe. We
are currently subject to a variety of regulations in Germany and
expect to become subject to additional foreign regulations as we
expand our operations. Our failure to comply, or assertions that
we fail to comply, with these regulations, could harm our
business in a particular market or in general. To the extent we
decide to commence or expand operations in additional countries,
government regulations in those countries may prevent or delay
entry into, or expansion of operations in, those markets. For
example, the government of the Netherlands has received a
request to conduct an investigation into the safety of permanent
injectable aesthetic products, which could lead to restrictions
on the sale or use of these products, or heighten the
requirements for qualifying or licensing these products for
sale. Government actions such as these could delay or prevent
the introduction of ArteFill in international markets and limit
our ability to generate revenues.
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We may be subject, directly or indirectly, to state
healthcare fraud and abuse laws and regulations and, if we are
unable to fully comply with such laws, could face substantial
penalties. |
Our operations may be directly or indirectly affected by various
broad state healthcare fraud and abuse laws. In particular, our
activities with respect to ArteFill will potentially be subject
to anti-kickback laws in some states, which prohibit the giving
or receiving of remuneration to induce the purchase or
prescription of goods or services, regardless of who pays for
the goods or services. These laws, sometimes referred to as
all-payor anti-kickback statutes, could be construed to apply to
certain of our sales and marketing and physician training and
support activities. In particular, our provision of practice
support services such as marketing or promotional activities
offered to trained and accredited physicians could be construed
as an economic benefit to these physicians that constitutes an
unlawful inducement of the physicians to recommend ArteFill to
their patients. If our operations, including our anticipated
business relationships with physicians who use ArteFill, are
found to be in violation of these laws, we or our officers may
be subject to civil or criminal penalties, including large
monetary penalties, damages, fines and imprisonment. If
enforcement action were to occur, our business and financial
condition would be harmed.
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Risks Related to Our Common Stock
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We may be subject to the assertion of claims by our
stockholders relating to prior financings, which could result in
litigation and the diversion of our managements
attention. |
Investors in certain of our prior financings may allege that we
failed to satisfy all of the requirements of applicable
securities laws in that certain disclosures to these investors
regrading our capitalization may not have been accurate in all
material respects, paperwork might not have been timely filed in
certain states and/or certain offerings may not have come within
a private-placement safe harbor. We believe that any such claims
would not succeed because we believe we have complied with these
laws in all material respects, such claims would be barred
pursuant to applicable statutes of limitations or such claims
could be resolved through compliance with certain state
securities laws. However, to the extent we do not succeed in
defending against any such claims and any such claims are not
barred or resolved, they could result in judgments for damages.
Even if we are successful in defending these claims, their
assertion could result in litigation and significant diversion
of our managements attention and resources.
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The price of our common stock may be volatile, and you may
not be able to sell your shares at or above the initial offering
price. |
Prior to this offering, there has been no public market for our
common stock. An active and liquid trading market for our common
stock may not develop or be sustained following this offering.
The market price for our common stock may decline below the
initial public offering price and our stock price is likely to
be volatile. You may not be able to sell your shares at or above
the initial public offering price. The stock markets in general,
and the markets for medical technology stocks in particular,
have experienced extreme volatility that has often been
unrelated to the operating performance of particular companies.
These broad market fluctuations may adversely affect the trading
price of our common stock. There have also been periods,
sometimes extending for many months and even years, where
medical technology stocks, especially of smaller earlier stage
companies like us, have been out of favor and trading prices
have remained low relative to other sectors.
Price declines in our common stock could result from general
market and economic conditions and a variety of other factors,
including:
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reports of adverse side effects resulting from treatment with
ArteFill; |
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adverse actions taken by regulatory agencies with respect to
open investigations, including the ongoing investigation by the
FDAs Office of Criminal Investigations involving
Drs. Gottfried and Stefan Lemperle and our company; |
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other adverse actions taken by regulatory agencies with respect
to our products, manufacturing processes or sales and marketing
activities or those of our competitors; |
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developments in any lawsuit involving us, our intellectual
property or our product or product candidates; |
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announcements of technological innovations or new products by
our competitors; |
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announcements of adverse effects of products marketed or in
clinical trials by our competitors; |
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regulatory developments in the United States and foreign
countries; |
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announcements concerning our competitors or the medical device,
cosmetics or pharmaceutical industries in general; |
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developments concerning any future collaborative arrangements; |
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actual or anticipated variations in our operating results; |
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lack of securities analyst coverage or changes in
recommendations by analysts; |
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deviations in our operating results from the estimates of
analysts; |
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sales of our common stock by our founders, executive officers,
directors, or other significant stockholders or other sales of
substantial amounts of common stock; |
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changes in accounting principles; and |
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loss of any of our key management, sales and marketing or
scientific personnel and any claims against us by current or
former employees. |
Litigation has often been brought against companies whose
securities have experienced volatility in market price. If
litigation of this type were to be brought against us, it could
harm our financial position and could divert managements
attention and our companys resources.
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We will have broad discretion in how we use the net
proceeds from this offering, and we may not use them
effectively. |
Our management will have considerable discretion in the
application of the net proceeds of the offering. We currently
intend to use the net proceeds from this offering to fund
expenses related to building our sales and marketing
organization and implementing promotional and advertising
campaigns related to the commercial launch of ArteFill,
conducting our long-term, post-market safety study of
approximately 1,000 patients treated with ArteFill, further
automating and expanding capabilities at our manufacturing
facilities and conducting further studies to evaluate the
feasibility, safety and efficacy of ArteFill for other aesthetic
applications and use in aesthetic reconstructive surgery, and
for working capital and general corporate purposes. We may also
use a portion of the net proceeds to acquire or to invest in
businesses, products or technologies that we believe are
complementary to our own, or to obtain the right to use such
complementary technologies. However, our plans may change and we
could spend the net proceeds in ways that do not necessarily
enhance the value of our common stock.
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If you purchase our common stock in this offering, you
will incur immediate and substantial dilution in the book value
of your shares. |
If you purchase shares in this offering, the value of your
shares based on our actual book value will immediately be less
than the offering price you paid. This reduction in the value of
your equity is known as dilution. This dilution occurs in large
part because our earlier investors paid substantially less than
the initial public offering price when they purchased their
shares. Investors purchasing common stock in this offering will,
therefore, incur immediate dilution of $3.41 in net tangible
book value per share of common stock, based on the initial
public offering price of $6.00 per share. Investors may
incur additional dilution upon the exercise of outstanding stock
options and outstanding warrants. In addition, if we raise funds
by issuing additional securities, the newly issued shares will
further dilute your percentage ownership of our company.
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A significant portion of our total outstanding shares are
restricted from immediate resale but may be sold into the market
in the near future. If there are substantial sales of our common
stock, the price of our common stock could decline. |
Sales of substantial amounts of our common stock in the public
market after the offering could adversely affect the price of
our common stock. After this offering, we will have
15,634,343 shares of common stock outstanding. All of the
shares offered under this prospectus will be freely tradable
without restriction or further registration under the federal
securities laws, unless purchased by our affiliates
as that term is defined in Rule 144 under the Securities
Act of 1933. The remaining 11,034,343 shares outstanding
upon the closing of this offering may be sold pursuant to
Rule 144, 144(k) or 701 of the Securities Act, unless the
holders of these shares are subject to the
lock-up agreements, or
other contractual arrangements, discussed below. The holders of
an aggregate of 11,606,882 shares of our outstanding common
stock and shares of common stock issuable upon the exercise of
outstanding warrants will have rights to cause us to file a
registration statement on their behalf and to include their
shares in registration statements that we may file on behalf of
other stockholders. Sales by our current stockholders of a
substantial number of shares after this offering, or the
expectation that such sales may occur, could significantly
reduce the market price of our common stock. After the
completion of this offering, substantially all of our current
stockholders will be bound by a
180-day
lock-up agreement, or
other contractual
30
arrangements, that prohibits these holders from selling or
transferring their stock for 180 days following the
offering, other than in specific circumstances. However, Cowen
and Company, LLC and Lazard Capital Markets LLC, on behalf of
the underwriters, at their discretion, can waive the
restrictions of the
lock-up agreement, and
we can waive the restrictions of the contractual arrangements,
at an earlier time without prior notice or announcement and
allow our stockholders to sell their shares of our common stock
in the public market. If the restrictions of the
lock-up agreement, or
other contractual arrangements, are waived, shares of our common
stock will be available for sale into the market, subject only
to applicable securities rules and regulations, which may cause
our stock price to decline. The
lock-up agreements with
the underwriters are subject to limited extension under certain
circumstances if analysts publish reports about our company or
we make announcements about our business within 15 days of
expiration of the lock-up. In addition, certain of our directors
and executive officers may choose to establish programmed
selling plans under
Rule 10b5-1 under
the Securities Exchange Act of 1934, as amended, or the Exchange
Act, for the purpose of effecting sales of common stock after
the expiration of the
lock-up period.
Promptly following this offering, we intend to register
approximately 5.7 million shares of common stock that
underlie outstanding stock options or are authorized for
issuance under our employee benefit plans. Once we register
these shares, they can be freely sold in the public market upon
issuance, subject to vesting provisions, restrictions under the
securities laws and the
lock-up agreements, or
other contractual arrangements, described above. If any of our
stockholders cause a large number of securities to be sold in
the public market, the sales could reduce the trading price of
our common stock. These sales also could impede our ability to
raise capital in the future.
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|
|
You could experience substantial dilution of your
investment as a result of subsequent exercises of our
outstanding warrants and options. |
As of September 30, 2006, we had reserved approximately
4.9 million shares of our common stock for potential
issuance upon the exercise of warrants and options (including
outstanding warrants to purchase preferred stock and common
stock, options already granted under our stock option plans,
non-plan stock options already granted and shares reserved for
future grant under our stock option plans), which represented
approximately 30.8% of our common stock on a fully diluted basis
(assuming the conversion into common stock of all outstanding
preferred stock and the exercise of all outstanding warrants and
options). Of the 4.9 million shares of common stock
reserved at September 30, 2006, 1.9 million shares of
common stock are reserved for outstanding stock options at a
weighted average exercise price of $5.85 per share;
2.5 million shares of common stock are reserved for
outstanding warrants to purchase preferred stock and common
stock, after considering the impact of the warrant holder
elections eliminating the automatic expiration and extending the
terms of the warrants upon the closing of our initial public
offering, at a weighted average exercise price $6.98 per
share (on an as-converted to common stock basis); and
0.5 million shares of common stock are reserved for future
stock option grants under our 2001 Plan. In addition, we have
reserved 3,640,843 shares of our common stock for future
grant under our 2006 Equity Incentive Plan, which will become
effective upon the closing of this offering. The issuance of
these additional shares could substantially dilute your
ownership interest in our company.
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|
|
Our certificate of incorporation, our bylaws and Delaware
law contain provisions that could discourage another company
from acquiring us and may prevent attempts by our stockholders
to replace or remove our current management. |
Provisions of our certificate of incorporation and bylaws that
we intend to adopt prior to the completion of this offering and
Delaware law may discourage, delay or prevent a merger or
acquisition that stockholders may consider favorable, including
transactions in which you might otherwise receive a premium for
your shares. In addition, these provisions may frustrate or
prevent any attempts by our stockholders to replace or remove
our current management by making it more difficult for
stockholders to replace or remove our board of directors. These
provisions include:
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authorizing the issuance of blank check preferred
stock without any need for action by stockholders; |
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providing for a classified board of directors with staggered
terms; |
31
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requiring supermajority stockholder voting to effect certain
amendments to our certificate of incorporation and bylaws; |
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eliminating the ability of stockholders to call special meetings
of stockholders; |
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prohibiting stockholder action by written consent; and |
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establishing advance notice requirements for nominations for
election to the board of directors or for proposing matters that
can be acted on by stockholders at stockholder meetings. |
We are also subject to provisions of the Delaware corporation
law that, in general, prohibit any business combination with a
beneficial owner of 15% or more of our common stock for five
years unless the holders acquisition of our stock was
approved in advance by our board of directors. Together, these
charter and statutory provisions could make the removal of
management more difficult and may discourage transactions that
otherwise could involve payment of a premium over prevailing
market prices for our common stock.
32
INFORMATION REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including the sections titled Prospectus
Summary, Risk Factors, Managements
Discussion and Analysis of Financial Condition and Results of
Operations and Business, contains
forward-looking statements. The words may,
continue, estimate, intend,
plan, will, believe,
project, expect, could,
would, anticipate and similar
expressions may identify forward-looking statements, but the
absence of these words does not necessarily mean that a
statement is not forward-looking. These forward-looking
statements include, among other things, statements about:
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our ability to establish and maintain the sales and marketing
organization required for successful commercialization of
ArteFill; |
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the timing of our commercial shipments of ArteFill, including
our shipments of the skin tests required before treatment with
ArteFill; |
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our ability to achieve and maintain market acceptance of
ArteFill among physicians and patients; |
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our projected expenditures on sales and marketing,
manufacturing, physician training and support, and research and
development activities; |
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the comparative advantages of ArteFill over temporary muscle
paralytics, temporary dermal fillers and other competing
products or treatments; |
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our ability to successfully complete our five-year post-market
safety study of ArteFill and a post-market study regarding the
incidence of allergic reactions to the bovine collagen used in
ArteFill; |
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our ability to expand our supply of calf hides for purposes of
producing our bovine collagen; |
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our existing stockholders willingness to purchase up to
approximately 800,000 shares of our common stock in this
offering at the initial public offering price; |
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our ability to establish, maintain and protect our intellectual
property rights in ArteFill and our other proprietary
technologies; and |
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our anticipated use of the proceeds from this offering and our
estimates regarding anticipated operating expenses, future
revenues from the commercialization of ArteFill and our capital
requirements. |
Any or all of our forward-looking statements in this prospectus
may turn out to be inaccurate. We have based these
forward-looking statements on our current assumptions and
projections about future events and financial trends that we
believe may affect our business, financial condition and results
of operations. They may be affected by inaccurate assumptions we
might make or by known or unknown risks and uncertainties,
including the risks, uncertainties and assumptions described in
Risk Factors. In light of these risks, uncertainties
and assumptions, the forward-looking events and circumstances
discussed in this prospectus may not occur as contemplated, and
our actual results could differ materially from those
anticipated or implied by the forward-looking statements.
These forward-looking statements speak only as of the date of
this prospectus. Unless required by law, we do not intend to
publicly update or revise any forward-looking statements to
reflect new information or future events or otherwise. You
should, however, review the factors and risks we describe in the
reports we will file from time to time with the SEC after the
date of this prospectus. See Where You Can Find More
Information.
33
USE OF PROCEEDS
We estimate that the net proceeds to us from the sale of the
4,600,000 shares of common stock we are offering will be
approximately $21.9 million, based on the initial public
offering price of $6.00 per share, after deducting
underwriting discounts and commissions and the estimated
offering expenses payable by us. If the underwriters exercise
their over-allotment
option in full, we estimate the net proceeds to us from this
offering will be approximately $25.7 million, based on the
same assumptions.
Of the net proceeds we will receive in this offering, we expect
to use approximately:
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$12.0 million to build our sales and marketing organization
and implement promotional and advertising campaigns related to
the commercial launch of ArteFill; |
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$5.0 million to conduct our long-term, post-market safety
study of approximately 1,000 patients treated with
ArteFill, as a condition of regulatory approval; |
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$2.5 million to further automate and expand capacity at our
manufacturing facilities; and |
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$2.0 million to conduct further studies to evaluate the
feasibility, safety and efficacy of ArteFill for other aesthetic
applications, such as the treatment of acne scars and wounds,
and use in aesthetic reconstructive surgery. |
We intend to use the remainder of our net proceeds for working
capital and general corporate purposes. We may also use a
portion of our net proceeds to acquire or to invest in
businesses, products or technologies that we believe are
complementary to our own, or to obtain the right to use such
complementary technologies. We currently have no commitments
with respect to any acquisition or investment.
The amounts and timing of our actual expenditures may vary
significantly depending upon numerous factors, including the
timing of our initial commercial shipments of ArteFill, the
progress of our commercialization efforts, and our operating
costs and capital expenditures. We will retain broad discretion
in the allocation of the net proceeds of this offering, and we
reserve the right to change the specific allocation of use of
these proceeds. Pending use of the net proceeds from this
offering, we intend to invest the net proceeds of this offering
in short-term, interest-bearing, investment-grade securities. We
cannot predict whether the proceeds invested will yield
favorable returns. We believe that our available cash, together
with the net proceeds of this offering and the funds available
under our credit facility, will be sufficient to meet our
capital requirements for at least the next 12 months.
DIVIDEND POLICY
We have never declared or paid any cash dividends on our capital
stock and we do not currently anticipate declaring or paying
cash dividends on our capital stock in the foreseeable future.
We currently intend to retain all of our future earnings, if
any, to finance the operation and expansion of our business. Any
future determination relating to our dividend policy will be
made at the discretion of our board of directors and will depend
on a number of factors, including future earnings, capital
requirements, financial conditions, future prospects,
contractual restrictions and covenants and other factors that
our board of directors may deem relevant.
34
CAPITALIZATION
The following table summarizes our capitalization as of
September 30, 2006:
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on an actual basis; and |
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|
on a pro forma as adjusted basis to give effect to the
conversion of all outstanding shares of convertible preferred
stock as of September 30, 2006 into shares of common stock;
the issuance of 107,754 shares of our common stock issuable
upon the exercise of preferred stock and common stock warrants
outstanding as of September 30, 2006, at a weighted average
exercise price of $5.58 per share, which the warrant holders
have elected to exercise in cash, contingent and effective upon
the completion of this offering; the issuance of
168,148 shares of our common stock upon the exercise of
preferred stock and common stock warrants outstanding as of
September 30, 2006, which the warrant holders have elected
to exercise through a cashless exercise provision of
the warrants, contingent and effective upon the completion of
this offering, based on the initial public offering price of
$6.00 per share; and the sale of the shares of our common stock
we are offering in this offering at the initial public offering
price of $6.00 per share, after deducting underwriting
discounts and commissions and estimated offering expenses
payable by us. |
|
You should read the following table in conjunction with
Managements Discussion and Analysis of Financial
Condition and Results of Operations, Description of
Capital Stock and our financial statements and related
notes appearing elsewhere in this prospectus.
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As of September 30, | |
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2006 | |
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| |
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|
Pro forma | |
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|
Actual | |
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as adjusted | |
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| |
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| |
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|
(in thousands, except | |
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|
share and par value | |
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data) | |
Long-term obligations, less current portion(1)
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$ |
31 |
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$ |
31 |
|
Stockholders equity:
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Convertible preferred stock, $0.001 par value:
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50,000,000 shares authorized, actual;
10,000,000 shares authorized pro forma as adjusted;
37,891,897 shares issued and outstanding, actual; no shares
issued and outstanding, pro forma as adjusted
|
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38 |
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Common stock, $0.001 par value: 150,000,000 shares
authorized, actual; 200,000,000 shares authorized pro forma
as adjusted; 1,390,930 shares issued and outstanding,
actual; and 15,634,343 shares issued and outstanding pro
forma as adjusted
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1 |
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16 |
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Additional paid-in capital
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94,144 |
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116,061 |
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Deficit accumulated during the development stage
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(71,648 |
) |
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(71,648 |
) |
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Total stockholders equity
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22,535 |
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44,429 |
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Total capitalization
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$ |
22,566 |
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$ |
44,460 |
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(1) The pro forma as adjusted amount does not include the
draw down of $5 million under the Companys term loan
credit facility, which occurred in November 2006. See
Note 11 of Notes to the Consolidated Financial Statements.
35
The above table is based upon shares outstanding as of
September 30, 2006 and excludes:
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1,869,676 shares of our common stock issuable upon the
exercise of stock options outstanding as of September 30,
2006, at a weighted average exercise price of $5.85 per
share; |
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335,246 shares of our common stock issuable upon the
exercise of outstanding stock options granted after
September 30, 2006, at a weighted average exercise price of
$10.63 per share; |
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3,640,843 shares of our common stock available for future
grant under our 2006 Equity Incentive Plan, which will become
effective upon the closing of this offering, and the annual
increases in the number of shares authorized under this plan
beginning January 1, 2007; |
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2,490,189 shares of our common stock issuable upon the
exercise of preferred stock and common stock warrants
outstanding as of September 30, 2006, at a weighted average
exercise price of $6.98 per share; and |
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28,235 shares of common stock issuable upon the exercise of
a preferred stock warrant granted after September 30, 2006
at an exercise price of $10.63 per share. |
36
DILUTION
If you invest in our common stock, your interest will be diluted
immediately to the extent of the difference between the public
offering price per share you will pay in this offering and the
pro forma net tangible book value per share of our common stock
immediately after this offering.
Our pro forma net tangible book value as of September 30,
2006 was approximately $18.7 million, or $1.73 per
share. Pro forma net tangible book value per share is determined
by dividing the amount of our total tangible assets less our
total liabilities of $18.7 million by the pro forma
number of shares of common stock totaling 10,758,441 shares
after giving effect to the conversion of all outstanding shares
of our preferred stock as of September 30, 2006 into shares
of our common stock, which will become effective at the closing
of this offering.
After giving effect to the sale of the 4,600,000 shares of
common stock we are offering at the initial public offering
price of $6.00 per share, and after deducting underwriting
discounts and commissions and our estimated offering expenses
payable by us, and giving effect to the issuance of
275,902 shares of common stock from the exercise of certain
warrants in connection with this offering, our pro forma as
adjusted net tangible book value as of September 30, 2006
would have been approximately $40.6 million, or
$2.59 per share.
This amount represents an immediate increase in pro forma net
tangible book value of $0.86 per share to our existing
stockholders and an immediate dilution of $3.41 per share
to new investors. The following table illustrates this
calculation on a per share basis:
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Initial public offering price per share
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$ |
6.00 |
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Pro forma net tangible book value per share of common stock as
of September 30, 2006
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$ |
1.73 |
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Pro forma increase per share attributable to the offering
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.86 |
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Pro forma as adjusted net tangible book value per share of
common stock after this offering
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2.59 |
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Dilution per share to new investors
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$ |
3.41 |
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If the underwriters exercise their over-allotment option in
full, our pro forma as adjusted net tangible book value will
increase to $2.72 per share, representing an increase to
our existing stockholders of $1.03 per share, and there
will be an immediate dilution of $3.28 per share to new
investors.
The following table summarizes, on a pro forma as adjusted basis
as of September 30, 2006, after giving effect to this
offering, and the pro forma adjustments referred to above, the
total number of shares of our common stock purchased from us and
the total consideration and average price per share paid by
existing stockholders and by new investors:
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Total shares | |
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Total consideration | |
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Average price | |
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Number | |
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Percent | |
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Amount | |
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Percent | |
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per share | |
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Existing stockholders
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11,034,343 |
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70.6 |
% |
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$ |
81,556,051 |
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74.7 |
% |
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$ |
7.39 |
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New investors
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4,600,000 |
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29.4 |
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27,600,000 |
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25.3 |
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6.00 |
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Total
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15,634,343 |
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100 |
% |
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$ |
109,156,051 |
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100 |
% |
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$ |
6.98 |
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If the underwriters exercise their over-allotment option in
full, the following will occur:
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the pro forma as adjusted percentage of shares of our common
stock held by existing stockholders will decrease to
approximately 67.6% of the total number of pro forma as adjusted
shares of our common stock outstanding after this
offering; and |
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the pro forma as adjusted number of shares of our common stock
held by new public investors will increase to 5,290,000, or
approximately 32.4% of the total pro forma as adjusted number of
shares of our common stock outstanding after this offering. |
37
The tables and calculations above are based on
11,034,343 shares of our common stock outstanding as of
September 30, 2006 after giving effect to:
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the conversion of all outstanding shares of preferred stock into
9,367,511 shares of common stock; |
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the issuance of 107,754 shares of our common stock upon the
exercise of preferred stock and common stock warrants
outstanding as of September 30, 2006, at a weighted average
exercise price of $5.58 per share, which the warrant holders
have elected to exercise in cash, contingent and effective upon
the closing of this offering; and |
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the issuance of 168,148 shares of our common stock upon the
exercise of preferred stock and common stock warrants
outstanding as of September 30, 2006, which the warrant holders
have elected to exercise through a cashless exercise
provision of the warrants, based on the initial public offering
price of $6.00 per share. |
The tables and calculations above exclude:
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1,869,676 shares of our common stock issuable upon the
exercise of stock options outstanding as of September 30,
2006, at a weighted average exercise price of $5.85 per
share; |
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335,246 shares of our common stock issuable upon the
exercise of outstanding stock options granted after
September 30, 2006, at a weighted average exercise price of
$10.63 per share; |
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3,640,843 shares of our common stock available for future
grant under our 2006 Equity Incentive Plan, which number
excludes the cancellation of 121,355 outstanding stock
options cancelled after September 30, 2006, at a weighted
average exercise price of $6.30 per share, which will
become effective upon the closing of this offering, and the
annual increases in the number of shares authorized under this
plan beginning January 1, 2007; |
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2,490,189 shares of our common stock issuable upon the
exercise of preferred stock and common stock warrants
outstanding as of September 30, 2006, at a weighted average
exercise price of $6.98 per share; |
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28,235 shares of common stock issuable upon the exercise of
a preferred stock warrant granted after September 30, 2006
at an exercise price of $10.63 per share; and |
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the impact of approximately $2.7 million of estimated
offering costs payable by us that we have previously paid in
cash as of September 30, 2006. |
The preceding discussion and tables assume no exercise of any
options and warrants outstanding as of September 30, 2006,
except as specifically described above.
38
SELECTED CONSOLIDATED FINANCIAL DATA
The following selected consolidated financial data should be
read in conjunction with Managements Discussion and
Analysis of Financial Condition and Results of Operations
and our audited consolidated financial statements and related
notes included elsewhere in this prospectus. We derived the
consolidated statement of operations data for the years ended
December 31, 2001 and 2002, as well as the consolidated
balance sheet data as of December 31, 2001, 2002 and 2003,
from our audited consolidated statements not included in this
prospectus. We derived the consolidated statements of operations
data for the years ended December 31, 2003, 2004 and 2005,
as well as the consolidated balance sheet data as of
December 31, 2004 and 2005, from our audited consolidated
financial statements included elsewhere in this prospectus. The
consolidated statement of operations data for the nine months
ended September 30, 2005 and 2006, and the consolidated
balance sheet data as of September 30, 2006, are derived
from our unaudited consolidated financial statements, which are
included elsewhere in this prospectus. Our historical results
are not necessarily indicative of operating results to be
expected in future periods.
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Nine Months Ended | |
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Years Ended December 31, | |
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September 30, | |
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2001 | |
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2002 | |
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2003 | |
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2004 | |
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2005 | |
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2005 | |
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2006 | |
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(unaudited) | |
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(in thousands, except share and per share amounts) | |
Consolidated Statements of Operations Data:
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Expenses:
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|
|
|
|
|
|
|
|
Research and development
|
|
$ |
2,811 |
|
|
$ |
1,457 |
|
|
$ |
974 |
|
|
$ |
3,634 |
|
|
$ |
10,189 |
|
|
$ |
6,754 |
|
|
$ |
5,698 |
|
|
Selling, general and administrative
|
|
|
2,096 |
|
|
|
1,975 |
|
|
|
2,976 |
|
|
|
5,155 |
|
|
|
10,137 |
|
|
|
6,723 |
|
|
|
11,463 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses
|
|
|
4,907 |
|
|
|
3,432 |
|
|
|
3,950 |
|
|
|
8,789 |
|
|
|
20,326 |
|
|
|
13,477 |
|
|
|
17,161 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(4,907 |
) |
|
|
(3,432 |
) |
|
|
(3,950 |
) |
|
|
(8,789 |
) |
|
|
(20,326 |
) |
|
|
(13,477 |
) |
|
|
(17,161 |
) |
Interest expense, net
|
|
|
(134 |
) |
|
|
(914 |
) |
|
|
(2,170 |
) |
|
|
(4,028 |
) |
|
|
(4,416 |
) |
|
|
(3,518 |
) |
|
|
(1,907 |
) |
Other income (expense), net
|
|
|
99 |
|
|
|
|
|
|
|
|
|
|
|
(22 |
) |
|
|
2,041 |
|
|
|
(11 |
) |
|
|
351 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before benefit for income taxes
|
|
|
(4,942 |
) |
|
|
(4,346 |
) |
|
|
(6,120 |
) |
|
|
(12,839 |
) |
|
|
(22,701 |
) |
|
|
(17,006 |
) |
|
|
(18,717 |
) |
Benefit for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
454 |
|
|
|
458 |
|
|
|
141 |
|
|
|
148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(4,942 |
) |
|
$ |
(4,346 |
) |
|
$ |
(6,120 |
) |
|
$ |
(12,385 |
) |
|
$ |
(22,243 |
) |
|
$ |
(16,865 |
) |
|
$ |
(18,569 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$ |
(4.66 |
) |
|
$ |
(4.10 |
) |
|
$ |
(5.76 |
) |
|
$ |
(11.20 |
) |
|
$ |
(18.76 |
) |
|
$ |
(14.38 |
) |
|
$ |
(13.81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares - basic and diluted
|
|
|
1,060,117 |
|
|
|
1,060,117 |
|
|
|
1,062,825 |
|
|
|
1,106,188 |
|
|
|
1,185,387 |
|
|
|
1,172,419 |
|
|
|
1,344,503 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss per common share (unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(5.15 |
) |
|
|
|
|
|
$ |
(1.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares - pro forma basic and diluted (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,319,411 |
|
|
|
|
|
|
|
9,885,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation is included in the following categories:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized to inventory
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
214 |
|
|
|
Research and development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
91 |
|
|
|
256 |
|
|
|
113 |
|
|
|
267 |
|
|
|
Selling, general and administrative
|
|
|
|
|
|
|
|
|
|
|
159 |
|
|
|
1,042 |
|
|
|
1,038 |
|
|
|
389 |
|
|
|
1,324 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
159 |
|
|
$ |
1,133 |
|
|
$ |
1,294 |
|
|
$ |
502 |
|
|
$ |
1,805 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39
See our consolidated financial statements and related notes for
a description of the calculation of the historical and pro forma
net loss per common share and the weighted-average number of
shares used in computing the historical and pro forma per share
data.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of | |
|
|
As of December 31, | |
|
September 30, | |
|
|
| |
|
| |
|
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
625 |
|
|
$ |
55 |
|
|
$ |
36 |
|
|
$ |
2,269 |
|
|
$ |
6,930 |
|
|
$ |
12,789 |
|
Working capital (deficit)
|
|
|
(27 |
) |
|
|
(2,036 |
) |
|
|
(2,659 |
) |
|
|
(3,792 |
) |
|
|
(2,974 |
) |
|
|
12,403 |
|
Total assets
|
|
|
1,122 |
|
|
|
220 |
|
|
|
450 |
|
|
|
10,296 |
|
|
|
20,320 |
|
|
|
29,745 |
|
Long-term debt and capital lease obligations, less current
portion
|
|
|
1,511 |
|
|
|
2,255 |
|
|
|
371 |
|
|
|
5,323 |
|
|
|
66 |
|
|
|
31 |
|
Stockholders equity (deficit)
|
|
|
(1,347 |
) |
|
|
(4,139 |
) |
|
|
(2,628 |
) |
|
|
(4,594 |
) |
|
|
5,537 |
|
|
|
22,535 |
|
40
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial
condition and results of operations should be read in
conjunction with our consolidated financial statements and
accompanying notes included elsewhere in this prospectus. In
addition to the historical information, this discussion and
other parts of the prospectus contain forward-looking statements
based upon current expectations that involve risks and
uncertainties. As a result of several factors, including those
set forth under Risk Factors and elsewhere in this
prospectus, our actual results and the timing of selected events
may differ materially from those anticipated in these
forward-looking statements.
Overview
We are a medical technology company focused on developing,
manufacturing and commercializing a new category of injectable
aesthetic products for the dermatology and plastic surgery
markets. On October 27, 2006, the FDA approved ArteFill,
our non-resorbable aesthetic injectable implant for the
correction of facial wrinkles known as smile lines, or
nasolabial folds. Currently, there are two categories of
injectable aesthetic products used for the treatment of facial
wrinkles: temporary muscle paralytics, which block nerve
impulses to temporarily paralyze the muscles that cause facial
wrinkles, and temporary dermal fillers, which are injected into
the skin or deeper facial tissues beneath a wrinkle to help
reduce the appearance of the wrinkle. Unlike existing temporary
muscle paralytics and temporary dermal fillers, which are
comprised of materials that are completely metabolized and
absorbed by the body, ArteFill is a proprietary formulation
comprised of polymethylmethacrylate, or PMMA, microspheres and
bovine collagen, or collagen derived from calf hides. PMMA is
one of the most widely used artificial materials in implantable
medical devices, and is not absorbed or degraded by the human
body. Following injection, the PMMA microspheres in ArteFill
remain intact at the injection site and provide a permanent
support structure to fill in the existing wrinkle and help
prevent further wrinkling. As a result, we believe that ArteFill
will provide patients with aesthetic benefits that may last for
years.
We intend to commence commercial shipments of ArteFill during
the first quarter of 2007. Our strategy is to establish ArteFill
as a leading injectable aesthetic product. We plan to drive the
adoption of our product through a direct sales and marketing
effort to dermatologists, plastic surgeons and cosmetic surgeons
in the United States. We initially intend to target
dermatologists, plastic surgeons and cosmetic surgeons whom we
have identified as having performed a significant number of
procedures involving injectable aesthetic products. In
connection with our product launch, we intend to provide
physicians with comprehensive education and training programs.
We believe our education and training programs will enable
physicians to improve patient outcomes and satisfaction. After
establishing ArteFill in the United States, we plan to explore
opportunities to register and sell ArteFill in selected
international markets. In addition, we may expand our product
offering by acquiring complementary products, technologies or
businesses.
Since our inception in 1999, we have incurred significant losses
and have never been profitable. We have devoted substantially
all of our efforts to product development and clinical trials,
to acquire international rights to certain intangible assets and
know-how related to our technology, and to establish commercial
manufacturing capabilities. To date, we have generated no
revenues. As of September 30, 2006, our deficit accumulated
during the development stage was approximately
$71.6 million.
We have financed our operations through private placements of
preferred stock and convertible debt. As of December 31,
2005, we have raised $34.0 million through private
placements of preferred stock, $6.9 million in
subscriptions for the purchase of Series E convertible
preferred stock and $6.0 million through the issuance of
convertible debt that remained outstanding as of
December 31, 2005. In addition, as of September 30,
2006, we raised an additional $36.1 million in a private
placement of Series E convertible preferred stock. Since
inception, we have raised $77.0 million through private
equity financings. As of September 30, 2006, our cash and
cash equivalents were $12.8 million.
41
Financial Operations Overview
Since inception in 1999, we have not generated any product
sales. We intend to commence commercial shipments and begin
generating product sales from ArteFill during the first quarter
of 2007.
Cost of sales will consist primarily of expenses related to the
manufacturing and distribution of ArteFill, including expenses
related to our direct and indirect manufacturing personnel,
quality assurance and quality control, manufacturing and
engineering, supply chain management, facilities and occupancy
costs. We will also incur expenses related to manufacturing
yield losses, product returns and rejects, procurement from our
manufacturing materials supply and distribution partners and
amortization of deferred stock-based compensation for our direct
and indirect manufacturing personnel.
From January 1, 2003 through September 30, 2006, we
have not incurred any cost of sales expenses, since we did not
commercially manufacture any product during that period.
Initially, we expect cost of sales to increase substantially to
meet projected sales volume demand for ArteFill. While the
direct material costs for ArteFill are expected to represent a
small portion of our cost of sales, our manufacturing cost
structure includes a large fixed cost component that will be
spread out over future production unit volumes. We anticipate
the economies of scale of manufacturing our product and future
automation efforts will be a significant factor in reducing
future unit manufacturing costs to generate improved gross
margins.
|
|
|
Selling, General and Administrative Expenses |
Our selling, general and administrative expenses will be
comprised of the following:
|
|
|
|
|
sales and marketing expenses, which primarily consist of the
personnel and related costs of our U.S. sales force,
customer service, marketing and brand management functions,
including direct costs for advertising and promotion of our
product; and |
|
|
|
general and administrative costs, which primarily consist of
corporate executive, finance, legal, human resources,
information systems, investor relations and general
administrative functions. |
From January 1, 2003 through September 30, 2006, we
spent an aggregate of approximately $29.7 million on
selling, general and administrative expenses, which represented
approximately 59% of total operating expenses. After this
offering, we anticipate substantial increases in our selling,
general and administrative expenses as we add personnel to our
direct U.S. sales force and expand our other marketing
functions. The size of the increase depends on the size of our
sales force, as well as the extent of marketing, advertising and
promotional efforts either directly or through third parties. We
also anticipate increases in general and administrative costs as
we add personnel to meet the anticipated expansion of our
product commercialization efforts and become subject to investor
relations, financial reporting and corporate governance
obligations applicable to publicly held companies.
|
|
|
Research and Development Expenses |
A significant majority of our research and development expenses
consist of expenses incurred by external service providers for
preclinical, clinical trials, technology and regulatory
development projects. Research and development expenses also
include costs incurred for process development and validation to
scale up our commercial operations to meet cGMP manufacturing
requirements prior to final approval from the FDA to market our
product. We have also incurred personnel costs related to
internal development of our product. Because we have been
focused on obtaining final FDA approval for ArteFill, we
currently maintain a limited in-house research and development
organization for new product development and have concentrated
our resources on manufacturing and process development to meet
FDA cGMP requirements. In January 2004, we received an
approvable letter from the FDA for our PMA application,
indicating that ArteFill is safe and effective for the
correction of facial wrinkles known as smile lines, or
nasolabial folds. In January 2006, we submitted an amendment to
our PMA application to address certain conditions to final
marketing approval set
42
forth in the FDAs approvable letter, and in April 2006,
the FDA completed comprehensive pre-approval inspections of our
manufacturing facilities in San Diego, California and
Frankfurt, Germany. On May 3, 2006, the FDA issued an EIR,
indicating that its inspection of our facilities was completely
closed, requiring no further action on the part of our company
related to the inspection. On October 27, 2006, the FDA
approved ArteFill for commercial sale in the United States.
We expense research and development costs as they are incurred.
From January 1, 2003 through September 30, 2006, we
spent an aggregate of approximately $20.5 million on
research and development expenses, which represented
approximately 41% of total operating expenses, excluding the
impact of stock-based compensation charges. We currently plan to
conduct limited research and clinical development activities to
evaluate the feasibility, safety and efficacy of ArteFill for
other aesthetic applications, such as the treatment of acne
scars and wounds, and use in aesthetic reconstructive surgery.
We also plan to explore applications of our injectable
microsphere platform technology in non-aesthetic medical
applications through collaborative arrangements with strategic
partners.
|
|
|
Amortization of Acquired Intangible Assets |
Acquired intangible assets, consisting of core technology and
international patents, are recorded at fair market value as of
the acquisition date. Fair market value is determined by an
independent third party valuation and is amortized over the
estimated useful life. This determination is based on factors
such as technical
know-how and trade
secret development of our core PMMA technology, patent life,
forecasted cash flows, market size and growth, barriers to
competitive entry and existence and the strength of competing
products.
Critical Accounting Policies and Estimates
This discussion and analysis of our financial condition and
results of operations is based on our consolidated financial
statements, which have been prepared in accordance with
generally accepted accounting principles in the United States.
The preparation of financial statements requires us to make
estimates and assumptions that affect the reported amounts of
assets, liabilities, expenses and related disclosures. Actual
results could differ from those estimates. While our significant
accounting policies are described in more detail in Note 1
of the Notes to Consolidated Financial Statements included
elsewhere in this prospectus, we believe the following
accounting policies to be critical to the judgments and
estimates used in the preparation of our consolidated financial
statements:
Since inception, we have not had any sales of our product. We
intend to commence commercial shipments of ArteFill during the
first quarter of 2007. We will recognize revenue from product
sales when (i) there is persuasive evidence that an
arrangement exists, (ii) delivery of the product has
occurred and title has transferred to our customers,
(iii) the selling price is fixed and determinable and
(iv) collection is reasonably assured. Provisions for
discounts to customers, returns or other adjustments will be
recorded as a reduction of revenue and provided for in the same
period that the related product sales are recorded based upon
analysis of historical discounts and returns. When terms of sale
are Free on Board, or FOB, shipping point, revenue will be
recognized at the time of shipment and when the terms of sale
are FOB destination point, revenue will be recognized when the
products have reached the destination point and other criteria
for revenue recognition have been met. Shipping and handling
charges are invoiced to customers based on the amount of
products sold. Shipping and handling fees are recorded as
revenue and the related expense is recorded as cost of sales.
We expect a substantial amount of our business to be transacted
using credit cards. We may offer an early payment discount to
certain customers. We also may provide customers with certain
product return rights in the case of damaged or defective
product. Once we have experience with actual product sales and
customer product returns, we will determine the appropriate
reserve for product returns. Our inability to accurately
estimate product returns in the future may cause us to defer
recognition of revenue.
43
|
|
|
Allowance for Doubtful Accounts |
Once we have experience in actual collections with our
customers, we will analyze the collectibility of our accounts
receivable, historical bad debts, customer concentrations,
customer credit-worthiness, current economic trends and changes
in customer payment terms in evaluating whether an allowance
needs to be made during the period. The expense related to the
allowance for doubtful accounts is recorded in selling, general
and administrative.
Inventories are stated at the lower of cost or market, with cost
being determined under a standard cost method, which
approximates a
first-in, first-out
basis. Our inventories are evaluated and any non-usable
inventory is expensed. In addition, we reserve for any inventory
that may be excess or potentially non-usable. Charges for such
write-offs and reserves are recorded as a component of cost of
sales. Changes in demand in the future could cause us to have
additional write-offs and reserves.
|
|
|
Impairment of Long-Lived Assets |
We review long-lived assets, including property and equipment
and intangibles, for impairment whenever events or changes in
business circumstances indicate that the carrying amount of the
assets may not be fully recoverable. An impairment loss would be
recognized when estimated undiscounted future cash flows
expected to result from the use of the asset and its eventual
disposition is less than its carrying amount. Impairment, if
any, is measured as the amount by which the carrying amount of a
long-lived asset exceeds its fair value. To date, we have not
recorded any impairment losses.
Intangible assets are comprised of acquired core technology and
patents recorded at fair market value less accumulated
amortization. Amortization is recorded on the straight-line
method over the estimated useful lives of the intangible assets.
Asset Valuation Allowance
Significant management judgment is required in determining our
provision for income taxes, our deferred tax assets and
liabilities and any valuation allowances recorded against our
net deferred tax assets. We have historically had net losses and
have not been required to provide for income tax liabilities. We
have established a valuation allowance with respect to all of
our U.S. deferred tax assets. Changes in our estimates of future
taxable income may cause us to reduce the valuation allowance
and require us to report income tax expense in amounts
approximating the statutory rates.
Deferred Tax Liability
A deferred tax liability was created on the date of purchase of
our wholly-owned German-based manufacturing subsidiary as there
was no allocation of the purchase price to the intangible asset
for tax purposes, and the foreign subsidiarys tax basis in
the intangible asset remained zero. Emerging Issues Task Force,
or EITF, Issue No. 98-11, Accounting for Acquired
Temporary Differences in Certain Purchase Transactions That Are
Not Accounted for as Business Combinations, requires the
recognition of the deferred tax impact of acquiring an asset in
a transaction that is not a business combination when the amount
paid exceeds the tax basis of the asset on the acquisition date.
Further, EITF 98-11 requires the use of simultaneous
equations to determine the assigned value of an asset and the
related deferred tax liability.
Stock-Based Compensation Expense
Effective January 1, 2006, we adopted Statement of
Financial Accounting Standards (SFAS) No. 123R,
Share-Based Payment (SFAS No. 123(R)), which
revises SFAS No. 123, Accounting for Stock-Based
44
Compensation and (SFAS No. 123), supersedes
Accounting Principles Board Opinion No. 25, Accounting
for Stock Issued to Employees (APB 25).
SFAS No. 123(R) requires that share-based payment
transactions with employees and directors be recognized in the
financial statements based on their grant-date fair value and
recognized as compensation expense over the requisite service
period. Prior to January 1, 2006, we accounted for our
stock-based employee and director compensation plans using the
intrinsic value method under the recognition and measurement
provisions of Accounting Principles Board Opinion (APB) 25,
Accounting for Stock Issued to Employees, and related
guidance. We adopted SFAS No. 123(R) effective
January 1, 2006, prospectively for new equity awards issued
subsequent to January 1, 2006, therefore prior period
results have not been restated. The adoption of SFAS
No. 123(R) in the first quarter of 2006 resulted in the
recognition of additional stock-based compensation expense for
the nine months ended September 30, 2006 of $749,000. Of
this amount, $89,000 has been capitalized to inventory, $76,000
is included in research and development expenses and $584,000 is
included in selling, general and administrative expenses.
Under SFAS No. 123(R), we calculated the fair value of the
stock option grants using the Black-Scholes option-pricing
model. For the nine months ended September 30, 2006, the
fair value was based on the following weighted average
assumptions: the expected term of 6.0 years; the expected
volatility of 60%, the risk free interest rate of 4.55% and 0%
for the dividend yield. Future expense amounts for any
particular quarterly or annual period could be affected by
changes in our assumptions or changes in market conditions.
The weighted average expected term for the nine months ended
September 30, 2006 reflects the application of the
simplified method set out in SEC Staff Accounting Bulletin
No. 107 (SAB 107), which was issued in March 2005. The
simplified method defines the expected term as the average of
the contractual term of the options and the weighted average
vesting period for all option tranches.
Estimated volatility for the nine months ended
September 30, 2006 also reflects the application of
SAB 107 interpretive guidance and, accordingly incorporates
historical volatility of similar public entities.
Total unrecognized stock-based compensation costs related to
unvested stock option and warrant awards at September 30,
2006 is $7,751,000, all of which arose from the adoption of SFAS
No. 123(R). The unrecognized cost is expected to be
recognized on a straight-line basis over a weighted average
period of four years.
Equity instruments issued to non-employees are recorded at their
fair values as determined in accordance with SFAS 123,
Accounting for Stock-Based Compensation, and Emerging
Issues Task Force
(EITF) 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling
Goods and Services, and are periodically revalued as the
options vest and are recognized as expense over the related
service period. During the years ended December 31, 2003,
2004, 2005, and for the nine months ended September 30,
2005 and 2006, and for the period from August 24, 1999
(inception) through September 30, 2006, we recognized
$159,000, $1,024,000, $959,000, $303,000, $495,000 and
$2,691,000, respectively, for stock options and warrants issued
to non-employees.
Deferred Stock-Based Compensation
Deferred stock-based compensation, which is a non-cash charge,
results from employee stock option grants at exercise prices
that, for financial reporting purposes, are deemed to be below
the estimated fair value of the underlying common stock on the
date of grant. Given the absence of an active market for our
common stock through 2005, our board of directors considered,
among other factors, the liquidation preferences, anti-dilution
protection and voting preferences of the preferred stock over
the common stock in determining the estimated fair value of the
common stock for purposes of establishing the exercise prices
for stock option grants.
As a result of initiating this offering process, and based on
discussions with our investment bankers, we have revised our
estimate of the fair value of our common stock for periods
beginning on and after July 1, 2004 for financial reporting
purposes. Our management, all of whom qualify as related
parties, determined that the stock options granted on and after
July 1, 2004 were granted at exercise prices that were
below the
45
reassessed fair value of our common stock on the date of grant.
We completed the reassessment of the fair value without the use
of an unrelated valuation specialist and started with the
proposed valuation from our investment bankers, considering a
number of accomplishments in 2004 and 2005 that would impact our
valuation, including achievement of key clinical milestones,
hiring executive officers, and the increased possibility of
completing this offering. Accordingly, deferred stock-based
compensation of $740,000 was recorded within stockholders
equity (deficit) during 2004 which represented the difference
between the weighted-average exercise price of $4.25 and the
weighted-average fair value of $6.38 on 324,705 options
granted to employees during 2004. Deferred stock-based
compensation of $2,383,000, net of forfeitures, was recorded
within stockholders equity (deficit) during 2005 which
represented the difference between the weighted-average exercise
price of $5.31 and the weighted-average fair value of $9.18 on
620,000 options granted to employees during 2005.
The deferred stock-based compensation is being amortized on a
straight-line basis over the vesting period of the related
awards, which is generally four years. The expected future
amortization expense for deferred stock-based compensation for
stock options granted through December 31, 2005, is
$789,000, $789,000, $703,000 and $458,000 for the years ending
December 31, 2006, 2007, 2008 and 2009, respectively.
During the years ended December 31, 2003, 2004, 2005, and
for the nine months ended September 30, 2005 and 2006, and
for the period from August 24, 1999 (inception) through
September 30, 2006, we recognized $0, $109,000, $335,000,
$199,000, $561,000 and $1,005,000, respectively, in expense
related to deferred stock-based compensation.
Upon the adoption of SFAS No. 123(R) on January 1,
2006, this deferred stock-based compensation was reclassified
against additional paid-in capital.
The above listing is not intended to be a comprehensive list of
all of our accounting policies. In many cases, the accounting
treatment of a particular transaction is specifically dictated
by generally accepted accounting principles, or GAAP. See our
consolidated financial statements and notes thereto included in
this report, which contain accounting policies and other
disclosures required by GAAP.
Results of Operations
|
|
|
Comparison of Nine Months Ended September 30, 2005 to
September 30, 2006 |
Research and development. Research and development
expense decreased by $1.1 million from $6.8 million
for the nine months ended September 30, 2005 to
$5.7 million for the nine months ended September 30,
2006. The decrease was primarily attributable to our transition
from the process development stage to the manufacturing of our
product. Included in our research and development expenses is
$0.9 million of amortization of core technology and patents
for each of the nine months ended September 30, 2005 and
September 30, 2006. Also included in research and
development expenses for the nine months ended
September 30, 2006 is a one-time warrant modification
charge of $0.1 million.
Selling, general and administrative. The following table
sets forth our selling, general and administrative expense for
the nine months ended September 30, 2005 and
September 30, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of | |
|
|
2005 | |
|
2006 | |
|
Change | |
|
|
| |
|
| |
|
| |
Sales and marketing
|
|
$ |
1,957 |
|
|
$ |
4,157 |
|
|
$ |
2,200 |
|
General and administrative
|
|
|
4,766 |
|
|
|
7,306 |
|
|
|
2,540 |
|
|
|
|
|
|
|
|
|
|
|
Total selling, general and administrative
|
|
$ |
6,723 |
|
|
$ |
11,463 |
|
|
$ |
4,740 |
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing expense increased by $2.2 million from
$2.0 million for the nine months ended September 30,
2005 to $4.2 million for the nine months ended
September 30, 2006. The increase was primarily attributable
to (i) $1.0 million in payroll and travel expenses for
additional personnel and (ii) $0.3 million for the
development of marketing and promotion programs and
(iii) $0.9 million in non-cash compensation expense,
including a one-time warrant modification charge of
$0.6 million.
46
General and administrative expense increased by
$2.5 million from $4.8 million for the nine months
ended September 30, 2005 to $7.3 million for the nine
months ended September 30, 2006. The increase was primarily
attributable to (i) a $1.6 million increase due to
additional executive and administrative personnel and related
travel expenses; (ii) $0.6 million in facilities
occupancy costs; (iii) a $0.7 million decrease in
professional service fees primarily related to lower legal
costs; (iv) $0.9 million in non-cash compensation
expense, which included a one-time warrant modification charge
of $0.2 million and (v) $0.1 million in office
related expenses.
Interest expense, net. Net interest expense decreased by
$1.6 million from $3.5 million for the nine months
ended September 30, 2005 to $1.9 million for the nine
months ended September 30, 2006. The net decrease was
primarily attributable to non-cash interest expense associated
with common stock warrants issued with a convertible promissory
note offset by an increase in interest income earned on our cash
balances. Included in interest expense for the nine months ended
September 30, 2006 is a one-time warrant modification
charge of $0.5 million.
Income tax benefit. We recognized an income tax benefit
of $141,000 and $148,000 for the nine months ended
September 30, 2005 and 2006, respectively. The income tax
benefit arose from the amortization of the deferred tax
liability attributable to the intangible asset acquired in the
purchase of our wholly-owned German-based manufacturing
subsidiary. A deferred tax liability was created on the date of
purchase as there was no allocation of the purchase price to the
intangible asset for tax purposes, and the foreign
subsidiarys tax basis in the intangible asset remained
zero. EITF 98-11 requires the recognition of the deferred
tax impact of acquiring an asset in a transaction that is not a
business combination when the amount paid exceeds the tax basis
of the asset on the acquisition date. Further, EITF 98-11
requires the use of simultaneous equations to determine the
assigned value of an asset and the related deferred tax
liability.
|
|
|
Comparison of Year Ended December 31, 2004 to
December 31, 2005 |
Research and development. Research and development
expense increased by $6.6 million from $3.6 million
for the year ended December 31, 2004 to $10.2 million
for the year ended December 31, 2005. The increase was
primarily attributable to (i) an increase of
$2.1 million in expenses related to process development,
contract service, materials and process validation;
(ii) payroll and travel costs of approximately
$3.1 million for additional personnel and
(iii) facilities occupancy costs of $1.4 million all
of which were directly attributable to the
scale-up of commercial
operations to manufacture our product to meet both FDA cGMP and
other regulatory agencies requirements. Included in our
research and development expenses is $1.2 million of
amortization of core technology and patents for each of the
years ended December 31, 2004 and December 31, 2005.
Selling, general and administrative. The following table
sets forth our selling, general and administrative expense for
the years ended December 31, 2004 and December 31,
2005 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of | |
|
|
2004 | |
|
2005 | |
|
Change | |
|
|
| |
|
| |
|
| |
Sales and marketing
|
|
$ |
339 |
|
|
$ |
2,777 |
|
|
$ |
2,438 |
|
General and administrative
|
|
|
4,816 |
|
|
|
7,360 |
|
|
|
2,544 |
|
|
|
|
|
|
|
|
|
|
|
Total selling, general and administrative
|
|
$ |
5,155 |
|
|
$ |
10,137 |
|
|
$ |
4,982 |
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing expense increased by $2.4 million from
$339,000 for the year ended December 31, 2004 to
$2.8 million for the year ended December 31, 2005. The
increase was primarily attributable to
(i) $1.4 million in payroll and travel expenses for
additional personnel; (ii) $847,000 for the development of
marketing and promotion programs and (iii) $121,000 for
marketing consultants.
General and administrative expense increased by
$2.5 million from $4.8 million for the year ended
December 31, 2004 to $7.3 million for the year ended
December 31, 2005. The increase was primarily attributable
to (i) a $1.4 million increase due to additional
executive and administrative personnel and related travel
expenses; (ii) $1.0 million in legal expenses and
(iii) $100,000 in other expenses.
47
Interest expense, net. We recognized net interest expense
of $4.4 million for the year ended December 31, 2005,
an increase of $400,000 from $4.0 million for the year
ended December 31, 2004. The increase was primarily
attributable to non-cash interest expense associated with common
stock warrants issued with a convertible promissory note.
We recognized other income of $2.1 million for the year
ended December 31, 2005, primarily due to a litigation
settlement payment.
Income tax benefit. We recognized an income tax benefit
of $454,000 and $458,000 for the years ended December 31,
2004 and 2005, respectively. The income tax benefit arose from
the amortization of the deferred tax liability attributable to
the intangible asset acquired in the purchase of our
wholly-owned German-based manufacturing subsidiary. A deferred
tax liability was created on the date of purchase as there was
no allocation of the purchase price to the intangible asset for
tax purposes, and the foreign subsidiarys tax basis in the
intangible asset remained zero. EITF 98-11 requires the
recognition of the deferred tax impact of acquiring an asset in
a transaction that is not a business combination when the amount
paid exceeds the tax basis of the asset on the acquisition date.
Further, EITF 98-11 requires the use of simultaneous
equations to determine the assigned value of an asset and the
related deferred tax liability.
|
|
|
Comparison of Year Ended December 31, 2003 to
December 31, 2004 |
Research and development. Research and development
expense increased by $2.6 million from $974,000 for the
year ended December 31, 2003 to $3.6 million for the
year ended December 31, 2004. The increase was primarily
attributable to (i) $1.2 million of amortization
expense related to our core technology and patents; (ii) an
increase of $637,000 in expenses related to process development,
contract service, materials and process validation;
(iii) payroll and travel costs of approximately $389,000
for additional personnel and (iv) facilities occupancy
costs of $404,000, all of which were directly attributable to
the scale-up of
commercial operations to manufacture our product to meet FDA
cGMP and other regulatory agencies requirements.
Selling, general and administrative. The following table
sets forth our selling, general and administrative expense for
the years ended December 31, 2003 and 2004 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of | |
|
|
2003 | |
|
2004 | |
|
Change | |
|
|
| |
|
| |
|
| |
Sales and marketing
|
|
$ |
314 |
|
|
$ |
339 |
|
|
$ |
25 |
|
General and administrative
|
|
|
2,662 |
|
|
|
4,816 |
|
|
|
2,154 |
|
|
|
|
|
|
|
|
|
|
|
Total selling, general and administrative
|
|
$ |
2,976 |
|
|
$ |
5,155 |
|
|
$ |
2,179 |
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing expense increased by $25,000 from $314,000
for the year ended December 31, 2003 to $339,000 for the
year ended December 31, 2004. The increase was primarily
attributable to payroll and travel expenses for additional
personnel, for the development of marketing and promotion
programs and for marketing consultants.
General and administrative expense increased by
$2.1 million from $2.7 million for the year ended
December 31, 2003 to $4.8 million for the year ended
December 31, 2004. The increase was primarily attributable
to (i) a $411,000 increase due to additional executive and
administrative personnel costs and (ii) $1.7 million
in legal and other expenses.
Interest and other expense, net. We recognized net
interest expense of $4.0 million for the year ended
December 31, 2004, an increase of $1.8 million from
$2.2 million for the year ended December 31, 2003. The
increase was attributable to non-cash interest expense
associated with common stock warrants issued with a convertible
promissory note.
Income tax benefit. We recognized an income tax benefit
of $0 and $454,000 for the years ended December 31, 2003
and 2004, respectively. The income tax benefit for fiscal 2004
arose from the amortization of the deferred tax liability
attributable to the intangible asset acquired in the purchase of
our wholly-owned
48
German-based manufacturing subsidiary. A deferred tax liability
was created on the date of purchase as there was no allocation
of the purchase price to the intangible asset for tax purposes,
and the foreign subsidiarys tax basis in the intangible
asset remained zero. EITF 98-11 requires the recognition of
the deferred tax impact of acquiring an asset in a transaction
that is not a business combination when the amount paid exceeds
the tax basis of the asset on the acquisition date. Further,
EITF 98-11 requires the use of simultaneous equations to
determine the assigned value of an asset and the related
deferred tax liability.
Income Taxes
Due to uncertainty surrounding the realization of the
U.S. deferred tax assets through future taxable income, we
have provided a full valuation allowance on those assets and no
benefit has been recognized for the U.S. net operating loss
and other U.S. deferred tax assets. Accordingly, deferred
tax valuation allowances have been established as of
December 31, 2003, 2004 and 2005 to reflect these
uncertainties.
As of December 31, 2005, we had net operating loss
carryforwards of approximately $43.0 million and
$43.0 million available to reduce future taxable income, if
any, for federal and California income taxes, respectively. The
net operating loss carryforwards begin to expire in 2019 and
2009 for federal and California income tax purposes,
respectively. Utilization of the net operating loss
carryforwards may be subject to an annual limitations due to the
ownership percentage change limitations provided by the Internal
Revenue Code of 1986 and similar state provisions. The annual
limitation may result in the expiration of the net operating
loss carryforwards before utilization.
Liquidity and Capital Resources
Since our inception in 1999, our operations have never been
profitable and we have an accumulated deficit of approximately
$71.6 million. Our operations have been financed through
private placements of convertible preferred stock and
convertible debt, as well as operating and capital leases. As of
December 31, 2005, we had raised $34.1 million through
private placements of preferred stock, $6.9 million through
subscriptions received for the purchase of Series E
convertible preferred stock and $6.0 million through the
issuance of convertible promissory notes. As of
December 31, 2005, our cash and cash equivalents were
$6.9 million. In addition, from January to September 2006,
we raised an additional $36.1 million in proceeds from the
sale of Series E convertible preferred stock. Since
inception, we have raised $77.0 million in private equity.
As of September 30, 2006, our cash and cash equivalents
were $12.8 million. All of our cash equivalents have
original maturities of three months or less.
Net cash used in operating activities. During the nine
months ended September 30, 2006, our operating activities
used cash of approximately $16.5 million, compared to
approximately $9.8 million for the nine months ended
September 30, 2005, an increase of $6.7 million. The
increase in cash used was due primarily to an increase in the
net loss of approximately $1.7 million, primarily
attributable to an increase in operating expenses, offset by
$1.5 million in adjustments for non-cash expenses and a
$6.5 million net decrease in operating assets and
liabilities primarily due to payments on accounts payable and
accrued expenses and an increase in inventory.
During the year ended December 31, 2005, our operating
activities used cash of approximately $13.1 million,
compared to approximately $4.8 million for the year ended
December 31, 2004, an increase of $8.3 million. The
increase in cash used was due primarily to an increase in the
net loss of approximately $9.9 million, primarily
attributable to an increase in research and development
expenses, offset by $1.4 million in adjustments for
non-cash expenses and a $200,000 net decrease in operating
assets and liabilities.
During the year ended December 31, 2004, our operating
activities used cash of approximately $4.8 million,
compared to approximately $2.8 million for the year ended
December 31, 2003, an increase of $2.0 million. The
increase in cash used was due primarily to an increase in the
net loss of approximately
49
$6.3 million, primarily attributable to an increase in
research and development expenses, offset by $4.6 million
in adjustments for non-cash expenses and a $321,000 net
increase in operating assets and liabilities.
Net cash used in investing activities. Our investing
activities used cash of approximately $3.3 during the nine
months ended September 30, 2006, compared to
$5.5 million for the nine months ended September 30,
2005. Investing activities during the nine months ended
September 30, 2006 and 2005 were comprised of $1.4 and
$3.9 million, respectively, of purchases of plant and
production equipment and tenant improvements related to the
expansion of our offices and the build-out of our production and
manufacturing facilities. During the nine months ended
September 30, 2005, we used $1.5 million of cash to
purchase our German-based manufacturing subsidiary, Artes
Medical Germany GmbH (formerly Mediplant GmbH Biomaterials &
Medical Devices). During the nine months ended
September 30, 2006, we used cash of $1.9 million for
long-term deposits and other assets, primarily capitalized as
initial public offering costs. During the nine months ended
September 30, 2005, we generated cash of $110,000 due to
changes in our long-term deposits and other assets.
Our investing activities used cash of approximately
$7.8 million during the year ended December 31, 2005,
compared to $2.5 million for the year ended
December 31, 2004. Investing activities in 2005 and 2004
were comprised of $4.6 million and $816,000, respectively,
of purchases of plant and production equipment and tenant
improvements related to the expansion of our offices and the
build-out of our production and manufacturing facilities. We
also used $2.3 million and $1.7 million in 2005 and
2004, respectively, of cash to purchase our German-based
manufacturing subsidiary, Artes Medical Germany GmbH, and in
2005 we used cash of $950,000 for long-term deposits and other
assets.
Our investing activities used cash of approximately
$2.5 million during the year ended December 31, 2004
compared to $250,000 for the year ended December 31, 2003.
Investing activities in 2004 were comprised of $1.7 million
in cash used to purchase our German-based manufacturing
subsidiary and $816,000 in equipment and tenant improvement
investments in our San Diego manufacturing facility. During
the same period in 2003, we used cash of $250,000 for long-term
deposits and other assets.
Net cash provided by financing activities. Cash provided
by financing activities was approximately $25.7 million for
the nine months ended September 30, 2006, compared to
approximately $15.1 million for the nine months ended
September 30, 2005. Financing activities during the nine
months ended September 30, 2006 resulted in
$31.8 million in proceeds from the issuance of preferred
stock, $431,000 in proceeds from the exercise of stock options,
repayments of $6.5 million on convertible notes payable and
$40,000 in repayments on capital lease obligations. During the
nine months ended September 30, 2005, our financing
activities resulted in $7.0 million in proceeds from the
issuance of convertible promissory notes, $4.5 million in
proceeds from the issuance of preferred stock, $3.4 million
in proceeds from subscriptions for preferred stock, $130,000 in
equipment financing obligations, net of repayments and $25,000
in proceeds from the exercise of stock options.
Cash provided by financing activities was approximately
$25.5 million for the year ended December 31, 2005,
compared to approximately $9.6 million for the year ended
December 31, 2004. Financing activities in 2005 resulted in
$7.0 million in proceeds from the issuance of convertible
promissory notes, $11.5 million in proceeds from the
issuance of preferred stock, $6.9 million in proceeds from
subscriptions for preferred stock and $116,000 in equipment
financing obligations, net of repayments during the year ended
December 31, 2005. During the same period in 2004, our
financing activities resulted in $6.1 million in proceeds
from the issuance of convertible promissory notes and
$3.5 million in proceeds from the issuance of preferred
stock. For the same period in 2003, we raised proceeds of
$1.5 million from the issuance of convertible promissory
notes and $1.6 million from the issuance of preferred stock.
In November 2006, we entered into a loan and security agreement
with Comerica Bank, pursuant to which we obtained a credit
facility consisting of a revolving line of credit in the amount
of up to $5.0 million and a term loan in the amount of up
to $5.0 million. Interest on the revolving line of credit
and the term loan will be at prime plus 2%. The revolving line
and term loan mature in November 2007 and 2010, respectively. We
are required to maintain a cash balance equal to 1.25 times our
indebtedness to Comerica Bank. In addition, the loan and
security agreement includes several restrictive covenants,
including requirements that we obtain the consent of Comerica
Bank prior to entering into any change of control event,
incurring other indebtedness or making distributions to our
stockholders. To secure the credit facility, we granted Comerica
50
Bank a first priority security interest in our assets and agreed
not to encumber our intellectual property rights without the
prior consent of Comerica Bank. On November 30, 2006, we
drew down the $5.0 million term loan under the credit
facility. We also granted Comerica Bank a warrant to purchase
28,235 shares of common stock, at an exercise price of
$10.63 per share.
Until we can generate significant cash from our operations, we
expect to continue to fund our operations with existing cash
resources that were primarily generated from the proceeds of
offerings of our equity securities, including the proceeds of
this offering. Based on our current operating plan, we expect to
incur costs of approximately $8.0 million to
$12.0 million over a 12-month period in connection with
establishing and building our internal sales force and sales
management to market ArteFill. We believe that the net proceeds
from this offering, together with the interest thereon, our cash
and cash equivalents at September 30, 2006 and the funds
available under our credit facility, will be sufficient to meet
our anticipated cash requirements with respect to the commercial
launch of ArteFill, the automation and scale-up of our
manufacturing capabilities and our research and development
activities and to meet our other anticipated cash needs through
the first quarter of 2008. In addition, we may finance future
cash needs through the sale of additional equity securities,
debt financing and other strategic transactions. However, we may
not be successful in obtaining strategic transactions to
commercialize our core technology in other medical applications
with third parties. In addition, our existing cash and cash
equivalents may not be adequate and additional equity or debt
financing may not be available when needed on acceptable terms,
or at all. Insufficient funds may require us to delay, reduce
the scope of or eliminate one or more of our product launch
programs, or to relinquish distribution rights to a third party
on less favorable terms than we would otherwise choose. Failure
to obtain adequate financing may also adversely affect our
ability to operate as a going concern. If we raise additional
funds by issuing equity securities, substantial dilution to
existing stockholders would likely result. If we raise
additional funds by incurring debt financing, the terms of the
debt may involve significant cash payment obligations as well as
covenants and specific financial ratios that may restrict our
ability to operate our business.
Our cash as of September 30, 2006, is expected to last
through the first quarter of 2007. Our future capital
requirements are difficult to forecast and will depend on many
factors, including, among others:
|
|
|
|
|
the costs of establishing and maintaining the sales and
marketing organization required for successful commercialization
of ArteFill; |
|
|
|
the success of our product launch and growth in sales and
related collections; |
|
|
|
the costs and effectiveness of our sales, marketing, advertising
and promotion activities related to ArteFill, including
physician training and education; |
|
|
|
the costs related to maintaining and expanding our manufacturing
and distribution capabilities; |
|
|
|
the costs relating to changes in regulatory policies or laws
that affect our operations; |
|
|
|
the level of investment in research and development to maintain
and improve our competitive position, as well as to maintain and
expand our technology platform; |
|
|
|
the costs of filing, prosecuting, defending and enforcing patent
claims and other intellectual property rights; |
|
|
|
the costs of, and our ability to enter into, foreign
distribution agreements in certain concentrated international
markets; and |
|
|
|
our need or determination to acquire or license complementary
products, technologies or businesses. |
If at any time sufficient capital is not available, either
through existing capital resources or through raising additional
funds, we may be required to delay, reduce the scope of,
eliminate or divest one or more of our sales and marketing
programs, manufacturing capabilities, research and development
programs, or our entire business. We may raise additional funds
through public or private offerings, debt financings, capital
51
leases, corporate collaborations or other means. Due to the
uncertainty of financial markets, financing may not be available
to us when we need it on acceptable terms or at all. Therefore,
we may raise additional capital from time to time when market
conditions are favorable, or if strategic considerations require
us to do so, even if we have sufficient funds for planned
operations.
The following summarizes our long-term contractual obligations
as of December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period | |
|
|
| |
|
|
Total | |
|
2006 | |
|
2007 | |
|
2008 | |
|
After 2008 | |
Contractual Obligations |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(in thousands) | |
Equipment lease obligations
|
|
$ |
115 |
|
|
$ |
49 |
|
|
$ |
45 |
|
|
$ |
21 |
|
|
$ |
|
|
Operating lease obligations
|
|
|
5,921 |
|
|
|
867 |
|
|
|
956 |
|
|
|
985 |
|
|
|
3,113 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
6,036 |
|
|
$ |
916 |
|
|
$ |
1,001 |
|
|
$ |
1,006 |
|
|
$ |
3,113 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our long-term obligations consist primarily of our facilities
leases that expire in March and December 2011 and our equipment
financing obligations that expire in April and July 2008.
In addition, pursuant to a separation agreement with
Dr. Gottfried Lemperle, we have paid Dr. Gottfried
Lemperle an aggregate of $400,000 through May 2006. We also paid
$500,000 to Stifel, Nicolaus & Company, Incorporated in
May 2006 in connection with a settlement agreement.
In November 2006, we entered into a separation agreement and
mutual general release with Dr. Stefan Lemperle in
connection with his resignation as a director and employee.
Pursuant to the agreement, we have paid Dr. Stefan Lemperle
a severance payment of $250,000, plus an additional $81,250 in
lieu of any bonus payments related to fiscal years 2005 and
2006. We also agreed to make severance payments to
Dr. Stefan Lemperle in an aggregate amount of $300,000,
payable in 12 monthly installments of $25,000 per month,
commencing in December 2006. Dr. Stefan Lemperle is
eligible to receive an additional severance payment of $400,000,
contingent upon the closing of this offering or another
qualifying transaction before March 31, 2007.
In November 2006, we entered into a loan and security agreement
with Comerica Bank, pursuant to which we obtained a credit
facility consisting of a revolving line of credit in the amount
of up to $5 million and a term loan in the amount of up to
$5 million. Interest on the revolving line of credit and
the term loan will be at prime plus 2%. On November 30,
2006, we drew down the $5.0 million term loan under the
credit facility.
We have entered into employment agreements with Diane Goostree,
our President and Chief Executive Officer, Russell Anderson, our
Vice President Product Development and Engineering
and Lawrence Braga, our Vice President
Manufacturing, pursuant to which we are obligated to make
certain severance payments to these individuals in the event
their employment with us is terminated under certain
circumstances.
Related Party Transactions
For a description of our related party transactions, see
Related Party Transactions elsewhere in this
prospectus.
Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet activities.
Quantitative and Qualitative Disclosures about Market Risk
The primary objective of our cash management activities is to
preserve our capital for the purpose of funding operations while
at the same time maximizing the income we receive from our
investments without significantly increasing risk. As of
December 31, 2005, we had cash and cash equivalents in a
bank operating
53
account that provides daily liquidity and through an overnight
sweep account that is a money market mutual fund and invests
primarily in money market investments and corporate and
U.S. government debt securities. Due to the liquidity of
our cash, cash equivalents and investment securities, a 1%
movement in market interest rates would not have a significant
impact on the total value of our cash, cash equivalents and
investment securities. We do not have any holdings of derivative
financial or commodity instruments, or any foreign currency
denominated transactions.
Inflation
The impact of inflation on our business has not been material to
date.
Recent Accounting Pronouncements
In November 2004, the Financial Accounting Standards Board, or
FASB, issued SFAS No. 151, Inventory Costs, an
amendment of Accounting Research Bulletin, or ARB, No. 43,
Chapter 4. This statement amends the guidance in ARB
No. 43, Chapter 4, Inventory Pricing, to
clarify the accounting for abnormal amounts of unallocated
overhead resulting from abnormally low production (or idle
capacity), freight, handling costs, and wasted material
(spoilage). This statement requires that those items be
recognized as current-period charges. In addition, this
statement requires that allocation of fixed production overheads
to the costs of conversion be based on the normal capacity of
the production facilities. The provisions of this statement will
be effective for inventory costs during the fiscal years
beginning after June 15, 2005. We are evaluating the impact
the adoption of this statement will have on our financial
condition and results of operations.
53
BUSINESS
Overview
We are a medical technology company focused on developing,
manufacturing and commercializing a new category of injectable
aesthetic products for the dermatology and plastic surgery
markets. On October 27, 2006, the FDA approved ArteFill,
our non-resorbable aesthetic injectable implant for the
correction of facial wrinkles known as smile lines, or
nasolabial folds. Currently, there are two categories of
injectable aesthetic products used for the treatment of facial
wrinkles: temporary muscle paralytics, which block nerve
impulses to temporarily paralyze the muscles that cause facial
wrinkles, and temporary dermal fillers, which are injected into
the skin or deeper facial tissues beneath a wrinkle to help
reduce the appearance of the wrinkle. Unlike existing temporary
muscle paralytics and temporary dermal fillers, which are
comprised of materials that are completely metabolized and
absorbed by the body, ArteFill is a proprietary formulation
comprised of polymethylmethacrylate, or PMMA, microspheres and
bovine collagen, or collagen derived from calf hides. PMMA is
one of the most widely used artificial materials in implantable
medical devices, and is not absorbed or degraded by the human
body. Following injection, the PMMA microspheres in ArteFill
remain intact at the injection site and provide a permanent
support structure to fill in the existing wrinkle and help
prevent further wrinkling. As a result, we believe that ArteFill
will provide patients with aesthetic benefits that may last for
years.
We conducted a controlled, randomized, double-masked,
prospective, multi-center U.S. clinical trial of 251 patients,
in which 128 patients received ArteFill, and 123 patients
received a control of either
Zyderm®
or
Zyplast®,
the leading bovine collagen-based temporary dermal fillers at
that time. Patients who received ArteFill in our clinical trial
showed wrinkle correction that persisted six months after
treatment. In contrast, patients who received the collagen
control in our clinical trial had returned to their
pre-treatment status by their six-month evaluation. As provided
in the study protocol, we offered all control group patients the
opportunity to be treated with ArteFill at their six-month
evaluation, and 91% of these patients accepted our offer. The
safety profiles for ArteFill and the collagen control were
comparable. In the 111 patients who were treated with
ArteFill and remained in the study at 12 months after
treatment, ArteFill demonstrated continued safety and wrinkle
correction. We did not evaluate the patients who received the
collagen control at 12 months after treatment because these
patients had either elected to be treated with ArteFill at their
six-month evaluation period or had returned to their
pre-treatment status. Our promotion of the efficacy benefits of
ArteFill is limited to the six-month efficacy evaluation period
that we established as the official endpoint in our
U.S. clinical trial.
We intend to commence commercial shipments of ArteFill during
the first quarter of 2007. We plan to sell ArteFill to
dermatologists, plastic surgeons and cosmetic surgeons in the
United States primarily through a direct sales force initially
comprised of up to 25 sales professionals. We initially intend
to target dermatologists, plastic surgeons and cosmetic surgeons
whom we have identified as having performed a large number of
procedures involving injectable aesthetic products. These
physicians are geographically concentrated in major urban
centers in the United States. In connection with our product
launch, we will train physicians in the technique of injecting
ArteFill with the goal of optimizing patient and physician
satisfaction with our product. After establishing ArteFill in
the United States, we plan to explore opportunities to
register and sell ArteFill in selected international markets.
Market Opportunity
Aesthetic procedures include non-surgical and surgical
treatments to improve or enhance a patients physical
appearance. According to the American Society for Aesthetic
Plastic Surgery, or the ASAPS, there were approximately
9.3 million non-surgical aesthetic procedures performed in
the United States in 2005, representing a total consumer market
of more than $4.1 billion. The leading non-surgical
aesthetic procedure in 2005 was the administration of injectable
aesthetic products, followed by laser hair removal,
microdermabrasion, chemical peel and the treatment of varicose
veins. Women represented 91.7% of the
54
patients who underwent non-surgical aesthetic procedures in
2005. Most non-surgical aesthetic procedures are considered to
be elective procedures, the cost of which must be paid for
directly by patients, and is not reimbursable through government
or private health insurance.
Based on published membership numbers of professional medical
associations, we believe that approximately 24,000 physicians in
the dermatology, plastic surgery and cosmetic surgery
specialties perform aesthetic procedures in the United States.
Based on our market research, we believe that a majority of
injectable aesthetic procedures are performed by approximately
1,000 physicians who are concentrated in major urban
centers in California, Florida, New York, Texas, Nevada, Arizona
and Illinois.
|
|
|
Injectable Aesthetic Treatment Market |
According to the ASAPS, injectable aesthetic treatments are the
largest and the fastest growing segment of the non-surgical
aesthetic treatment market. Injectable aesthetic products are
administered through a syringe into the facial skin or deeper
facial tissues in order to reduce the appearance of facial
wrinkles and scars and to add fullness to the lips and cheeks.
The ASAPS reported that, in 2005, approximately 4.9 million
injectable aesthetic procedures were performed in the
United States, and U.S. consumers spent approximately
$2.2 billion on injectable aesthetic treatments. Based on
market research conducted by Medical Insight, Inc., we believe
that physicians purchased approximately $600 million of
injectable aesthetic products for these treatments.
Industry research conducted by Medical Insight, Inc. projects
that the market for injectable dermal filler treatments will
expand at a compound annual growth rate through 2011 of more
than 25% in the United States and 20% throughout the rest of the
world. We believe the rapid growth in the injectable aesthetic
treatment market has been, and will continue to be driven
largely by:
|
|
|
|
|
the introduction of new products that offer improved aesthetic
benefits and longer lasting results; |
|
|
|
an increasing demand for minimally invasive and cost-effective
aesthetic treatments that offer immediate results; |
|
|
|
the aging of the baby boomer demographic segment, which
currently represents over 25% of the U.S. population; |
|
|
|
a growing emphasis on self-image driven by the media and an
increasingly youth-oriented culture; |
|
|
|
an increasing willingness of physicians to use products beyond
their labeled indications; and |
|
|
|
a growing trend among physicians to offer elective aesthetic
treatments to generate additional income. |
Currently, there are two categories of injectable aesthetic
products: temporary muscle paralytics and temporary dermal
fillers. Temporary muscle paralytics block nerve impulses to
temporarily paralyze the muscles that cause facial wrinkles.
Temporary dermal fillers are injected into the skin or deeper
facial tissues to plump up the skin under a wrinkle
or scar or to add fullness to tissues such as lips and cheeks.
Because the substances contained in these products are
completely metabolized and absorbed by the body over time,
repeat injections typically are required to maintain the
aesthetic effect.
55
The most widely used injectable aesthetic products currently
approved by the FDA for use in the United States for the
correction of facial wrinkles include:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approximate | |
|
|
|
|
|
|
Number of | |
|
|
|
|
|
|
Procedures | |
Product Category |
|
Leading Brands |
|
Ingredient |
|
Performed in 2005 | |
|
|
|
|
|
|
| |
Temporary Muscle Paralytics
|
|
Botox®
Cosmetic |
|
Botulinum toxin type A |
|
|
3,300,000 |
|
Temporary Dermal Fillers
|
|
Captiquetm
Hylaform®
Hylaform®
Plus
Restylane® |
|
Hyaluronic acid (HA) |
|
|
1,200,000 |
|
|
|
CosmoDerm®
CosmoPlast®
Zyderm®
Zyplast® |
|
Human or bovine collagen |
|
|
200,000 |
|
Physicians also may use other injectable products off-label,
beyond their FDA-approved labeled indications, to treat facial
wrinkles and scars. For example, physicians used
Radiessetm,
a calcium hydroxylapatite, or CaHA, based gel approved by the
FDA for vocal cord augmentation, radiographic tissue marking,
and oral and maxillofacial defects, or the loss of facial
structure and skin tissue, in approximately 40,000 aesthetic
procedures in 2005. In addition, physicians used
Sculptra®,
an injectable filler consisting of a combination of saline and
poly-L lactic acid, or PLLA, microspheres approved by the FDA
for the restoration and/or correction of the signs of facial fat
loss in people with human immunodeficiency virus, or HIV, in
approximately 35,000 aesthetic procedures in 2005. Similar to
the FDA-approved temporary dermal fillers listed above, the
substances contained in Radiesse and Sculptra are completely
metabolized and absorbed by the body over time.
Injectable aesthetic treatments usually involve multiple
injections into the area to be corrected, and may require more
than one office visit to obtain the desired aesthetic effect.
Treatments typically are administered in less than 30 minutes.
Patients often will receive a local anesthetic or nerve block,
typically by injection, to reduce pain during treatment,
especially for the treatment of sensitive areas around the lips.
The instructions for use of all treatments that contain bovine
collagen require physicians to administer a skin test for
allergic reactions to bovine collagen approximately 30 days
before a patients first treatment with the bovine
collagen-based product. Historically, approximately 3% of
patients test positive for bovine collagen allergies. We believe
the rate of allergic reactions to bovine collagen is inversely
related to the purity of the collagen.
|
|
|
Market Dynamics for Injectable Aesthetic Treatments |
The market for injectable aesthetic treatments is characterized
by the following:
Rapid market acceptance of innovative and/or longer lasting
aesthetic products. Injectable aesthetic products that offer
new or improved benefits and/or longer lasting aesthetic effects
have often achieved rapid market acceptance. Recent examples
include:
|
|
|
|
|
Botox. Botox treatments are the most common aesthetic
procedure performed in the United States. According to the
ASAPS, approximately 3.3 million Botox treatments for
aesthetic use were performed in the United States in 2005. Since
1997, Botox treatments have experienced a compound annual growth
rate of 63%, including a 16% procedure growth rate from 2004 to
2005. |
|
|
|
Restylane. Launched in January 2004, Restylane, a product
comprised primarily of hyaluronic acid, a jelly-like substance
that is found naturally in living organisms and acts to hydrate
and cushion skin tissue, has become the leading temporary dermal
filler approved by the FDA for the correction of facial
wrinkles. According to the ASAPS, the number of hyaluronic
acid-based procedures has increased significantly over the past
two years, from approximately 120,000 procedures in 2003, to
900,000 procedures in 2004 and to 1.2 million procedures in
2005. We believe this increase was mainly |
56
|
|
|
|
|
attributable to the market launch of Restylane, which provides
patients with a moderately longer lasting aesthetic benefit
compared to prior leading temporary dermal fillers, such as the
collagen-based Zyderm and Zyplast, and does not require a skin
test prior to treatment like bovine collagen-based products. |
Off-label use of available products. Physicians often use
injectable aesthetic products beyond their specific FDA-approved
indications. Off-label usage is common across medical
specialties because physicians often use their professional
judgment to decide whether an off-label use is the best
treatment option for their patients. The FDA does not regulate
the behavior of physicians in their choice of treatment options.
The FDA does, however, strictly prohibit a manufacturers
promotion, advertising and labeling of all off-label uses. FDA
penalties for promoting products off-label can include adverse
publicity, warning letters, fines, civil and criminal penalties,
injunctions and product seizures.
The following table highlights common off-label uses for several
major injectable aesthetic products as compared to their
FDA-approved indications:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approved by the |
|
|
|
|
|
|
|
|
FDA for the |
|
|
|
|
Product |
|
Leading |
|
Treatment of |
|
FDA-Approved |
|
Common Off-Label |
Formulation |
|
Brand(s) |
|
Facial Wrinkles |
|
Indications |
|
Uses |
|
|
|
|
|
|
|
|
|
Botulinum toxin type A |
|
Botox |
|
|
Yes |
|
|
Moderate to severe frown lines |
|
Forehead wrinkles; crows feet; and vertical neck bands |
Hyaluronic acid |
|
Captique Hylaform Restylane Juvederm |
|
|
Yes |
|
|
Moderate to severe facial wrinkles and folds, such as smile lines |
|
Forehead wrinkles; lip augmentation; and acne scars |
Bovine or human collagen |
|
CosmoDerm CosmoPlast Zyderm Zyplast |
|
|
Yes |
|
|
Soft tissue contour deficiencies such as wrinkles and acne scars |
|
Lip augmentation |
Calcium hydroxylapatite (CaHA) |
|
Radiesse |
|
|
No(1) |
|
|
Vocal cord augmentation, radiographic tissue marking, and oral
maxillofacial defects |
|
Smile lines; frown lines; crows feet; and lip augmentation |
Poly-L lactic acid (PLLA) |
|
Sculptra |
|
|
No |
|
|
Facial fat loss associated with HIV |
|
Smile lines; marionette lines; and facial contours |
|
|
(1) |
Radiesse is currently under review by the FDA for additional
applications, which we believe may include the treatment of
facial wrinkles. |
Use of injectable aesthetic products as complementary
treatments. Physicians commonly offer their patients
aesthetic treatments that incorporate multiple products or
procedures. For example, physicians commonly use more than one
injectable aesthetic product during a single treatment procedure
to achieve a desired result, such as combining Botox with a
dermal filler. Physicians also increasingly use longer lasting
injectable aesthetic products during surgical procedures, such
as facelifts, nose reconstructions and breast augmentation or
reconstruction.
Growing consumer base for injectable aesthetic
treatments. Increasing consumer awareness and social
acceptance of injectable aesthetic procedures have driven more
patients to consider these procedures for the first time.
Additionally, during initial patient consultations or following
an initial aesthetic treatment, physicians who perform aesthetic
procedures commonly inform their patients about other available
injectable aesthetic products and cosmetic treatment options.
57
|
|
|
Limitations of Current Treatments |
All injectable aesthetic products currently approved by the FDA
for the treatment of facial wrinkles contain substances that are
readily absorbed and completely metabolized by the body,
rendering their aesthetic effects relatively short-lived. The
following table highlights the time lapse between treatments
generally required to maintain a desired aesthetic effect with
existing FDA-approved products, as reported by the ASAPS:
|
|
|
|
|
|
|
|
|
|
|
Time Lapse between | |
Product Categories |
|
Representative Brands |
|
Treatments | |
|
|
|
|
| |
Botulinum toxin type A
|
|
Botox Cosmetic |
|
|
4 to 6 months |
|
Hyaluronic acid
|
|
Captique Hylaform Restylane |
|
|
4 to 12 months |
|
Bovine or human collagen |
|
CosmoDerm CosmoPlast Zyderm Zyplast |
|
|
3 to 6 months |
|
The temporary duration of these products limits their usefulness
to physicians and patients in the following ways:
|
|
|
|
|
Patients must undergo repeat injections to sustain aesthetic
benefits. In order to sustain the desired aesthetic
benefits, patients must undergo repeat injections, which involve
additional pain and inconvenience as a result of the multiple
facial injections and the recovery time associated with each
treatment. Some patients who undergo repeat injections may
develop scars and discoloration in the target tissue area, as
well as experience a decrease in the aesthetic effect of each
successive treatment over time. |
|
|
|
Cumulative cost of repeat injections. The cumulative cost
of repeat treatments required to maintain the desired aesthetic
benefits with currently available injectable aesthetic products
may decrease the appeal of these products to patients over time.
Based on data from the ASAPS, a patient treated with Botox
Cosmetic would need to undergo between 10 to 15 treatments over
a five year period to maintain the aesthetic benefit. A patient
treated with Restylane would need to undergo between five to 15
treatments to maintain the aesthetic benefit over a similar five
year period. Based on pricing data reported by the ASAPS, the
cumulative cost to the consumer of these treatments would be at
least $5,000 over five years. |
|
|
|
Risk to physician practices of patient attrition. The
expense, pain and inconvenience of a repeat injection regimen
can decrease patient satisfaction with injectable aesthetic
treatments and lead patients to discontinue treatments. Based on
our market research and discussions with physicians, we believe
that a significant percentage of patients suspend or cease
injectable aesthetic treatments within one year after their
first treatment. Patients who discontinue the use of injectable
aesthetic products may stop going to the physicians office
altogether, resulting in the physician losing the opportunity to
market additional products and services to these patients. |
|
|
|
Current products may have limited utility in conjunction with
aesthetic surgical procedures. Physicians sometimes use
injectable aesthetic products during surgical procedures, such
as facelifts, nose reconstructions or other facial
reconstruction procedures. The aesthetic effects provided by
these products, however, have a much shorter duration than the
aesthetic effects provided by surgical procedures. As a result,
surgeons have not widely adopted currently available injectable
aesthetic products for use in conjunction with surgical
procedures. |
Injectable products, such as Radiesse and Sculptra, that are
used off-label for the correction of facial wrinkles, present
similar limitations because they also contain substances that
are completely metabolized and absorbed by the body over time.
In addition, the aesthetic correction provided by Sculptra
typically is not
58
visible until several weeks after the initial treatment. We also
believe that the viscosity of Sculptra limits its off-label use
primarily to deep facial contour deficiencies and severe
wrinkles.
Due to these limitations, and given the growth and rapid
adoption of new, improved products within the market for
injectable aesthetic products, we believe that a significant
market opportunity exists for a safe and effective injectable
aesthetic product that can provide patients with immediate and
enduring aesthetic effects.
Our Solution ArteFill
ArteFill is a novel and proprietary injectable aesthetic implant
for the correction of nasolabial folds, or smile lines. In
October 2006, the FDA approved ArteFill for commercial sale in
the United States. ArteFill is the first product in a new
category of non-resorbable aesthetic injectable products for the
dermatology and plastic surgery markets. Unlike existing
temporary muscle paralytics and temporary dermal fillers, which
are comprised of materials that are completely metabolized and
absorbed by the body, ArteFill is a proprietary formulation
comprised of PMMA microspheres and purified bovine collagen.
Following injection, the PMMA microspheres in ArteFill remain
intact at the injection site and provide a permanent support
structure to fill in the existing wrinkle and help prevent
further wrinkling. As a result, we believe that ArteFill will
provide patients with aesthetic benefits that may last for
years. ArteFill has been shown to be safe and effective in our
U.S. clinical trials. We intend to commence commercial
shipments of ArteFill during the first quarter of 2007.
We believe that ArteFill will offer the following benefits to
physicians and patients:
|
|
|
|
|
Enduring aesthetic improvements. We have developed
ArteFill to provide patients with aesthetic benefits that we
believe may last for years. Based on clinical trial data, the
FDA has determined that ArteFill is safe and effective and has
allowed us to characterize it as a non-resorbable aesthetic
injectable implant. ArteFill is the first non-resorbable
injectable aesthetic product approved by the FDA for the
treatment of nasolabial folds. Patients who received ArteFill in
our clinical trial showed wrinkle correction that persisted six
months after treatment. In contrast, patients who received the
collagen control in our clinical trial had returned to their
pre-treatment status by their six-month evaluation. As provided
in the study protocol, we offered all control group patients the
opportunity to be treated with ArteFill at their six-month
evaluation, and 91% of these patients accepted our offer. In the
111 patients who were treated with ArteFill and remained in
our clinical trial at 12 months after treatment, ArteFill
demonstrated continued safety and wrinkle correction. We did not
evaluate the patients who received the collagen control at 12
months after treatment because at their six-month evaluation
period, these patients had either elected to be treated with
ArteFill or had returned to their pre-treatment status. Our
promotion of the efficacy benefits of ArteFill is limited to the
six-month efficacy evaluation period that we established as the
official endpoint in our U.S. clinical trial. |
|
|
|
Compelling value proposition to patients. We believe
patients treated with ArteFill, versus currently available
temporary injectable aesthetic products, will incur meaningfully
lower cumulative costs over time to maintain the desired
aesthetic effect. As a result, we believe ArteFill will present
patients with a compelling value proposition because it will
allow patients to avoid the cost of repeat injections required
by existing temporary injectable aesthetic products. |
|
|
|
High levels of patient satisfaction. We believe that the
enduring aesthetic improvements provided by ArteFill may
generate high levels of patient satisfaction by decreasing the
discomfort, cost and inconvenience associated with frequent
re-injections, which are required for existing injectable
aesthetic products. As a result, we believe that the increased
levels of patient satisfaction provided by our product will
contribute to longer term physician- patient relationships. |
|
|
|
Differentiated, high value product for physician
practices. We believe that the longer lasting aesthetic
benefits of ArteFill will enable physicians to offer their
patients a premium injectable aesthetic product and generate
additional practice revenue per procedure. |
59
|
|
|
|
|
Complement to surgical and non-surgical aesthetic
treatments. Because of its ability to provide patients with
aesthetic benefits that may last for years, we believe that
physicians may choose to adopt ArteFill as a valuable complement
to the various surgical and non-surgical aesthetic treatments
they provide to their patients. |
Our Strategy
Our goal is to become a leading medical technology company
focused on developing, manufacturing and commercializing a new
category of injectable aesthetic products for the dermatology
and plastic surgery markets. We plan to achieve this goal
through the following strategies:
|
|
|
|
|
Establish ArteFill as a leading injectable aesthetic
product. ArteFill is the first product in a new category of
non-resorbable aesthetic injectable products for the dermatology
and plastic surgery markets. We believe ArteFill will provide
patients with aesthetic benefits that may last for years.
Therefore, we intend to differentiate ArteFill from other
injectable aesthetic products and position ArteFill as the
premier enduring injectable aesthetic product for the treatment
of nasolabial folds. We plan to work closely with key opinion
leaders to drive physician and patient awareness of the unique
benefits of ArteFill. |
|
|
|
Provide physicians with comprehensive education and training
programs. In connection with the commercial launch of
ArteFill, we intend to implement a comprehensive physician
education and training program to foster consistent and
high-quality injection procedures and results. Our education and
training program will include web-based training, in-office and
off-site training seminars, as well as physician-to-physician
training. We believe our education and training programs will
enable physicians to improve patient outcomes and satisfaction. |
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Drive the adoption of our products through a direct sales and
marketing effort. We have recently begun to build our direct
sales team and initially intend to launch ArteFill with up to
30 full-time sales professionals. We initially intend to
target dermatologists, plastic surgeons and cosmetic surgeons
whom we have identified as having historically performed a
significant number of procedures involving injectable aesthetic
products. Based on our market research, we believe that a
majority of injectable aesthetic procedures are performed by
approximately 1,000 physicians concentrated in several
major urban centers in the United States. As part of our
marketing efforts, we intend to provide physicians with
training, marketing programs and practice support services with
respect to the use of ArteFill. We also plan to use targeted
marketing, advertising and promotional activities to educate
consumers about the benefits of ArteFill. |
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Expand our product offering by acquiring complementary
products, technologies or businesses. We may expand our
aesthetic product offerings by acquiring complementary products,
technologies or businesses that may be sold by our direct sales
force to dermatologists, plastic surgeons and cosmetic surgeons.
We also plan to explore additional uses of our injectable
microsphere platform technology in markets outside of personal
aesthetics through collaborative arrangements with strategic
partners. |
Our Product
ArteFill is composed of PMMA microspheres (20% by volume)
suspended in a water-based carrier gel (80% by volume)
containing bovine collagen and lidocaine, a local anesthetic.
ArteFill is a smooth, opaque, off-white gel. We intend to sell
ArteFill in kits containing five sterile pre-filled syringes. We
also will provide individual skin test kits, with each kit
containing five skin test syringes filled with our manufactured
bovine collagen.
PMMA Microspheres
ArteFill is a proprietary combination of round and smooth PMMA
microspheres, ranging from 30 to 50 microns in diameter,
suspended in a bovine collagen-based solution. PMMA is a
biocompatible synthetic polymer manufactured to the standards
required for use as a long-term medical grade implant. PMMA is
one
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of the most widely used artificial materials in implantable
medical devices and has been used for more than 60 years in
medical implants such as intraocular lenses and dental
prostheses. Scientific studies have shown that PMMA microspheres
are both biocompatible and safe for use in humans as soft tissue
fillers. These studies also show that human enzymes are unable
to metabolize PMMA because of its chemical structure. As a
result, PMMA microspheres are not degraded or absorbed by the
human body following injection.
The size, shape and smoothness of the PMMA microspheres utilized
in a soft tissue filler are important to the products
biocompatibility. Scientific studies have shown that round and
smooth microspheres, such as those contained in ArteFill, cause
less adverse tissue response compared to other irregular shapes.
We believe that PMMA microspheres with diameters of 30 to 50
microns are within the optimal size range for use in soft tissue
fillers because PMMA microspheres of this size are small enough
to be easily injected through a standard 26-gauge needle, but
are large enough to prevent migration from the implantation site
and to avoid removal of the microspheres by white blood cells.
We manufacture our PMMA microspheres at our manufacturing
facility in Frankfurt, Germany. We have developed a proprietary
manufacturing process that generates round and smooth
microspheres from medical grade PMMA. This proprietary process
ensures that our PMMA microspheres are of the proper size and
shape to meet the FDAs stringent quality requirements.
Bovine Collagen
We manufacture the bovine collagen contained in ArteFill at our
manufacturing facility in San Diego, California. Bovine
collagen has been used by plastic surgeons and dermatologists to
treat wrinkles and scars for over 25 years. To ensure both
safety and quality, we use a proprietary manufacturing process
to produce a highly purified and partly denatured bovine
collagen solution from calf hides. Historically, approximately
3% of patients test positive for allergies to bovine
collagen-based products. We believe that our collagen is among
the most highly purified injectable collagens in the medical
industry, and accordingly, may cause a lower incidence rate of
allergic reactions in patients, providing us with a competitive
advantage over other bovine collagen-based injectable aesthetic
products. None of the 391 patients in our U.S. clinical
trials tested positive for allergic reactions to our purified
bovine collagen. We plan to conduct a post-market study under an
FDA-approved protocol regarding the incidence of allergic
reactions to our collagen to determine whether the FDA would
approve treatment with ArteFill without a skin test.
We take numerous precautions to help ensure that our bovine
collagen is free from BSE. We purchase our supply of calf hides
from a herd that is isolated, bred and monitored in accordance
with both FDA and USDA guidelines. This closed herd provides a
reliable source of raw material, with backup capabilities in
case of natural disasters. We purchase only the hides of male
calves younger than six months of age. Studies of BSE outbreaks
have found that BSE typically manifests itself in female cattle
between 40 and 60 months of age. The youngest calf ever
detected with BSE was 19 months of age. These studies also
have found that BSE is more than 100 times more prevalent in
adult females than adult males. We currently have an
18 months supply of calf hides in frozen storage at
our manufacturing facility and intend to establish and maintain
a supply of calf hides that will last for more than two years.
The FDA has required that we continue to monitor the stability
of our bovine collagen for a sufficient period of time to
support the 18-month expiration date in our product label.
Lidocaine
ArteFill contains a local anesthetic, lidocaine (0.3%).
Lidocaine reduces patient discomfort during and after the
injection process, making ArteFill injections more convenient
for patients and physicians than other injectable aesthetic
products that do not contain a local anesthetic.
Storage and handling
We intend to sell ArteFill in kits containing five sterile
pre-filled syringes, sealed within a thermoformed tray. These
kits must be maintained in refrigerated storage at standard
domestic refrigerator temperatures
(4° to 8° C) for the duration of the
product shelf life. We ship each kit inside a container designed
to maintain
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the 4° to 8° C temperature requirement
during overnight transit. We believe most physicians who are
currently treating their patients with injectable aesthetic
products already have refrigerated storage capabilities in their
offices.
Our Proprietary Microsphere Technology
ArteFill is based on our proprietary combination of PMMA
microspheres and bovine collagen, which we believe serves to
stimulate the natural growth of a patients collagen in the
treated area. The bovine collagen in ArteFill provides for the
initial correction of a wrinkle and serves to maintain an even
distribution of the PMMA microspheres at the injection site,
while the PMMA microspheres act as a scaffold for the
patients own collagen deposition. After implantation, the
bovine collagen is gradually metabolized and absorbed by the
patients body. At the same time, the collagen-coated PMMA
microspheres stimulate fibroblasts, which are cells naturally
present in the patients body, to produce collagen that
encapsulates each individual microsphere. The PMMA microspheres
are designed not to migrate from the injection site while the
patients own collagen replaces the bovine collagen
component of ArteFill. The treated area eventually consists of
the patients own collagen encapsulating each of the PMMA
microspheres. We believe that the encapsulation of the PMMA
microspheres by the patients own collagen will provide
aesthetic improvements that may last for years.
ArteFill Treatment
ArteFill will be administered primarily in an out-patient
clinical setting, such as a physicians office. Treatment
with ArteFill is expected to require between 15 and 30 minutes.
Similar to the application of several widely used temporary
dermal fillers, the physician administers ArteFill through a
commonly used tunneling injection technique, in which the
physician moves the needle linearly beneath the skin wrinkle.
The physician can use the thickness of the needle as a gauge to
help determine the correct depth of the injection. Because
physicians are encouraged to avoid over-correction during the
initial injection, patients may require one or two
touch-up treatments in
intervals of at least two weeks to achieve the desired
aesthetic results.
As with all bovine collagen-based products, the instructions for
use of ArteFill require physicians to administer a skin test to
screen each patient for an allergic reaction to bovine collagen
before the patients first treatment. The skin test
involves the physician injecting our purified bovine collagen
into the patients forearm skin and the patient monitoring
the treatment area for 28 days. If there are no signs of
irritation during the
28-day monitoring
period, the patient can proceed with the ArteFill treatment. We
believe that our collagen is among the most highly purified
injectable collagens in the medical industry and that our
collagen accordingly may result in a lower rate of allergic
reactions in patients, providing us with a competitive advantage
over other bovine collagen-based injectable aesthetic products.
We plan to conduct a post-market study under an FDA-approved
protocol regarding the incidence of allergic reactions to our
collagen to determine whether the FDA would approve treatment
with ArteFill without a skin test.
Our Physician Training and Education Program
The goal of our training program is to maximize patient and
physician satisfaction with ArteFill by fostering consistent and
high-quality injection procedures. In the first quarter of 2007,
we intend to commence a comprehensive training program in order
to ensure that physicians are trained to inject ArteFill using a
common tunneling injection technique. We intend to offer
ArteFill only to physicians who have successfully completed our
training program. We will initially focus on training those
physicians whom we have identified as having significant
experience in performing injectable aesthetic procedures using
the tunneling injection technique. We have designed our training
program to be adaptable to each physicians level of prior
experience with this technique. Our training program includes
the following modules:
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Web-based Training. We will offer physicians a 30 minute
web-based interactive tutorial on ArteFills scientific
background, clinical trial information, injection technique and
treatment guidelines. |
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In-office Training. We will offer physicians who have
significant experience with the tunneling injection technique a
training program in their offices. The training will include an
injection technique video, an injection training manual and
reference materials. |
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Hands-on Training. Other physicians will participate in a
half-day educational program that provides in-depth injection
technique training. The program will include live demonstrations
and hands-on practice injecting ArteFill using training masks.
We will also provide training support, an injection training
manual and reference materials. |
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Physician-to-Physician Training. We will establish a peer
training program, through which physicians who are highly
skilled in the tunneling injection technique and have completed
our training program may participate in training other
physicians. |
Sales and Marketing
We intend to commence commercial shipments of ArteFill during
the first quarter of 2007. We are currently building a direct
sales force in the United States to sell ArteFill into the
dermatology and plastic surgery markets. We initially intend to
target dermatologists, plastic surgeons and cosmetic surgeons
whom we have identified as having performed a large number of
procedures involving injectable aesthetic products. We will
initially market ArteFill through our sales and marketing
organization, which will include up to 25 full-time sales
representatives. We anticipate that as demand for ArteFill
increases, we may expand our sales force to between 60 and 80
sales representatives.
Within the dermatology and plastic surgery markets, we believe
that there are approximately 24,000 physicians in the United
States, including approximately 14,000 dermatologists, 7,500
plastic and reconstructive surgeons and 2,500
facial/ear-nose-and-throat plastic surgeons. However, we believe
that only approximately 5,000 of these physicians offer
injectable aesthetic products to their patients. Furthermore, we
believe that a majority of injectable aesthetic procedures are
performed by approximately 1,000 physicians who are concentrated
in major urban centers in the United States, including
California, Florida, New York, Texas, Nevada, Arizona and
Illinois. Our initial sales effort will target these highly
experienced physicians and we expect that the size of our direct
sales organization will be appropriate to support our commercial
launch. We believe that targeting physicians highly experienced
with the injection technique used to administer ArteFill will
help drive market adoption.
We believe that the advantages of ArteFill over currently
available injectable aesthetic treatments for the correction of
facial wrinkles will allow us to position ArteFill as a premium
injectable aesthetic product. According to our market research,
we believe temporary injectable aesthetic products are not
meeting all of the needs of patients and physicians for lasting
treatment results, value and convenience. Based on its product
attributes, we believe ArteFill fills a void that currently
exists in the market for injectable aesthetic products. We plan
to market ArteFill to physicians at a premium price, supported
by the positioning of ArteFill as the first non-resorbable
aesthetic injectable implant for the treatment of nasolabial
folds. Based on our market research, we believe patients will be
willing to pay a premium price for ArteFill because the cost of
ArteFill will be lower than the cumulative costs of the
treatment regimen required by currently available temporary
injectable aesthetic products.
As part of our marketing strategy, we have developed programs to
support physicians and their practices and to foster a mutual
commitment to patient satisfaction. Specifically, these programs
include:
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technical skill support programs, such as advanced injection
training symposia; |
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promotional materials that provide a physicians patients
with information about ArteFill treatments; |
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marketing programs to assist physicians in developing their
patient base for ArteFill; and |
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participation in our web-based physician locator service. |
We also intend to market ArteFill to physicians through
scientific presentations at medical conferences and symposia,
advertising in scientific journals, industry trade publications
and our website. Following our
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product launch, we will continue to publish scientific articles
to expand physician awareness of our product, and we intend to
offer clinical forums with recognized expert panelists to
discuss their experience with ArteFill. We plan to build
consumer awareness of ArteFill through physician office
marketing programs, health and lifestyle magazine advertisements
and our website.
After establishing ArteFill in the United States, we also plan
to explore opportunities to register and sell ArteFill in
selected countries outside the United States.
Manufacturing
We have established our 43,000 square foot dedicated
manufacturing facility and corporate headquarters in
San Diego, California for the production of ArteFill. At
this facility, we utilize a proprietary manufacturing process to
produce purified and partly denatured bovine collagen from calf
hides for the water-based carrier gel, which includes 3.5%
purified bovine collagen. Our proprietary process includes viral
inactivation, extraction, purification and sterile filtration of
the collagen. Our viral inactivation procedure employs two
separate validated process steps to inactivate potential viruses
in the bovine corium, or inner layer of the calf skin. In
addition, we treat our bovine collagen with sodium hydroxide to
inactivate potential viruses. We create the final product at
this facility by evenly suspending our PMMA microspheres within
the water-based carrier gel, which includes 0.3% lidocaine,
through our proprietary sterile mixing and syringe filling
process. We then package the sterile pre-filled syringes into
kits.
We conduct our manufacturing operations at our San Diego
facility using sterile and calibrated equipment in dedicated
controlled rooms suitable for maintaining product sterility
consistent with Good Manufacturing Practice, or GMP,
regulations. Our clean room facilities include equipment
sterilizers and a water purification system, and are controlled
by an integrated building management system that monitors and
regulates air handling and temperature. Our product packaging
and labeling capabilities include sealing validations, sterile
barriers, transit testing, stability testing, as well as
process-validated labeling and barcode generation. We believe
our San Diego facility will be capable of supporting our
manufacturing, distribution and product development requirements
for the foreseeable future.
We currently manufacture our PMMA microspheres at our
1,750 square foot dedicated manufacturing facility in
Frankfurt, Germany. We utilize a proprietary manufacturing
process that generates round and smooth microspheres from
medical grade PMMA. The process extracts microspheres ranging
from 30 to 50 microns in diameter, and ensures that no more than
1% of the total number of microspheres are smaller than
20 microns in diameter. We then sterilize and package the
microspheres and ship them to our San Diego manufacturing
facility for final inspection and use in ArteFill. We believe
our Frankfurt facility has sufficient capacity to meet our needs
for PMMA microspheres for the foreseeable future. We intend to
implement redundant capabilities for the production of PMMA
microspheres at our San Diego facility. In addition, we
plan to further improve and automate our production process in
San Diego.
Manufacturing facilities that produce medical devices intended
for distribution in the United States and internationally are
subject to regulation and periodic unannounced review by the FDA
and other regulatory agencies. Manufacturing facilities that
produce medical devices intended for sale and distribution in
the European Economic Community, or EEC, are subject to
regulatory requirements of the Medical Devices Directive, or
MDD, as well as various International, or ISO, and European
National, or EN, standards. In Europe, Notified Bodies are
responsible for the enforcement of MDD regulations. In January
2006, KEMA, a European Notified Body, issued to us a quality
system certificate indicating that our facilities are in
compliance with ISO 13485, the internationally recognized
quality system standard for medical device manufacturers.
In March 2006, the FDA completed inspections of our
manufacturing facility and our contract sterilizer in Frankfurt,
Germany, with no observations noted. In addition, in April 2006,
the FDA completed a comprehensive pre-approval inspection of our
primary manufacturing facility in San Diego, California. During
this inspection, the FDA noted four minor observations, all of
which were corrected and annotated to the inspection report as
corrected. On May 3, 2006, the FDA issued an EIR,
indicating that its inspection of our manufacturing facilities
was completely closed, requiring no further action on the part
of our company
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related to the inspection. On October 27, 2006, the FDA
issued final certification of our facilities in connection with
its approval of ArteFill for sale in the United States.
We have manufactured ArteFill, including the PMMA microspheres
contained in the product, in limited quantities sufficient only
to meet the needs for our clinical studies. We currently have
limited resources, facilities and experience in commercially
manufacturing sufficient quantities to meet expected demand for
ArteFill. While we believe that our current facilities will be
sufficient to manufacture an adequate supply to meet initial
demand for ArteFill, in order to produce ArteFill in the
quantities we anticipate will be necessary to meet market
demand, we will need to increase our manufacturing capacity
significantly over the current level.
Material Agreements
In July 2004, we acquired assets and intellectual property from
FormMed BioMedicals AG, or FormMed, related to the development
and manufacture of PMMA microspheres used in the production of
ArteFill. This transaction had an effective date of
January 1, 2004. The assets acquired included rights to all
of FormMeds rights to any U.S. and international patents,
patent applications and trademarks related to the ArteFill
platform technology and Artes Medical Germany GmbH (formerly
MediPlant GmbH Biomaterials & Medical Devices), or
MediPlant, a facility for the manufacture of the PMMA
microspheres. The aggregate purchase price for these assets was
$4.3 million, which was paid in installments through
December 2005. We pledged certain of the acquired patents to
FormMed to secure our obligations with respect to the purchase
of the assets. This pledge was released in October 2005 in
connection with our settlement agreement with FormMed and
Dr. Martin Lemperle, the brother of Dr. Stefan M. Lemperle,
our former Chief Executive Officer and a former director, as
described below. We currently have no continuing financial
obligations under the acquisition agreement with FormMed.
We have in place an intercompany manufacturing and supply
agreement with our wholly-owned subsidiary, MediPlant, pursuant
to which MediPlant exclusively manufactures and supplies to us
the PMMA microspheres used in ArteFill. Under the terms of this
agreement, pricing for the PMMA microspheres is based on
MediPlants actual documented production costs, determined
in accordance with generally accepted accounting principles in
the United States, subject to adjustment, plus an additional
manufacturing profit. This agreement has an indefinite term, but
may be terminated by either us or MediPlant for cause, or by us
in the event of a supply failure or for convenience at any time
upon ninety days prior written notice of termination to
MediPlant.
We also have in place a supply agreement with Lampire Biological
Labs, Inc., or Lampire, pursuant to which Lampire sells to us
bovine corium, which is a highly purified and partly denatured
bovine collagen solution from which we manufacture the bovine
collagen contained in ArteFill. Under the terms of this
agreement, pricing is based on unit fees for the acquisition of
calves and for processing. Lampire has agreed to process the
bovine corium in strict accordance with general and
manufacturing process requirements to ensure safety and quality,
and to ensure that our bovine collagen is free from BSE. This
agreement has an initial term of one year and is subject to
automatic renewals of successive one-year periods.
In October 2005, we and Dr. Martin Lemperle entered into a
settlement and license agreement with BioForm Medical, Inc. and
BioForm Medical Europe B.V., pursuant to which all outstanding
disputes and litigation matters among the parties were settled.
Under the agreement, we granted to the BioForm entities an
exclusive, world-wide, royalty-bearing license under certain of
our patents to make and sell implant products containing CaHA
particles, and a non-exclusive, world-wide, royalty-bearing
license under the same patents to make and sell certain other
non-polymeric implant products, and the BioForm entities paid us
a technology access fee of $2.0 million for these rights. Under
the terms of the agreement, we are entitled to bring suit, at
our own expense, to enforce the licensed patents against any
third party infringers and to retain any and all damages,
including damages for harm to the sales of BioForm, its
affiliates or its sublicensees, obtained by us in our efforts to
stop the infringement. BioForm has agreed to provide reasonable
cooperation to us in connection with any such enforcement
action. In the event we are involved in a bankruptcy proceeding
or discontinue our business, then BioForm may, at it own expense
and for its own benefit, enforce the
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licensed patents. The settlement and license agreement remains
in effect so long as any of the patents licensed under the
agreement continues to have at least one valid and enforceable
claim that has not expired, lapsed, or been disclaimed or
permanently abandoned. We may terminate the license grants under
the agreement only if BioForm fails to make timely payment of a
royalty amount determined to be due to us by an arbitrator.
BioForm may terminate the agreement only if all licensed patents
that remain in force are in force solely by virtue of extensions
to the original patent terms, and the extensions do not cover
any products of BioForm or its sublicensees under the agreement.
In October 2005, we also entered into a settlement agreement
with FormMed and Dr. Martin Lemperle, pursuant to which we
paid to FormMed an aggregate cash fee of 427,500 Euro and issued
7,214 shares of common stock to FormMed in full
satisfaction of certain production costs disputed under the
FormMed asset acquisition agreement described above. We also
paid to Dr. Martin Lemperle an aggregate cash fee of
150,000 Euro and issued 2,549 shares of common stock to
Dr. Martin Lemperle in full satisfaction of his claims for
reimbursement of certain legal expenses. In addition, our pledge
of certain patents to FormMed under our asset acquisition
agreement with FormMed was released in connection with these
payments. We have no continuing financial obligations under the
settlement agreement with FormMed and Dr. Martin Lemperle.
In November 2006, we entered into a loan and security agreement
with Comerica Bank, pursuant to which we obtained a credit
facility consisting of a revolving line of credit in the amount
of up to $5.0 million and a term loan in the amount of up
to $5.0 million. Interest on the revolving line of credit
and the term loan will be at prime plus 2%. The revolving line
and term loan mature in November 2007 and 2010, respectively. We
are required to maintain a cash balance equal to 1.25 times our
indebtedness to Comerica Bank. In addition, the loan and
security agreement includes several restrictive covenants,
including requirements that we obtain the consent of Comerica
Bank prior to entering into any change of control event,
incurring other indebtedness or making distributions to our
stockholders. To secure the credit facility, we granted Comerica
Bank a first priority security interest in our assets and agreed
not to encumber our intellectual property rights without the
prior consent of Comerica Bank. On November 30, 2006, we
drew down the $5.0 million term loan under the credit
facility. In connection with the loan and security agreement, we
issued Comerica Bank a warrant to
purchase 28,235 shares of common stock at an exercise
price of $10.63 per share.
Competition
The market for injectable aesthetic products is intensely
competitive, subject to rapid change and significantly affected
by new product introductions. We will compete against other
medical technology and pharmaceutical companies who market
aesthetic products. In the United States, we will compete
primarily with companies that offer temporary injectable
aesthetic products approved by the FDA for the correction of
facial wrinkles, such as Medicis Pharmaceutical Corporation and
Allergan, Inc. In addition, we will compete with companies that
offer products that physicians currently use off-label for the
correction of facial wrinkles, including BioForm Medical, Inc.
and Dermik Laboratories, a subsidiary of sanofi-aventis. A
number of companies, such as Mentor Corporation, are currently
developing new products that may be used for the treatment of
facial wrinkles, although we believe none of them involve a
non-resorbable injectable aesthetic implant. We also will
compete with companies that offer different treatments for
facial wrinkles, including topical cosmeceuticals and creams,
chemical peels, laser skin treatments and microdermabrasion.
To compete effectively, we will need to demonstrate that
ArteFill is a unique and attractive alternative to these other
products and treatments. We believe the principal competitive
factors in our market include:
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safety and efficacy; |
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immediate and enduring aesthetic results; |
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cost-effectiveness to patients and physicians; |
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reduced pain and recovery time before a patient can return to
normal activities; |
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effectiveness of marketing and distribution; and |
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ability to leverage existing relationships with physicians and
distributors. |
In addition, in March 2006, Allergan completed its acquisition
of INAMED Corporation. As a result of this transaction, the
market for injectable aesthetic products experienced a
significant concentration of products within a single entity
with greater resources and the ability to provide an expanded
range of products and services and pricing programs. These
companies and others have developed and will continue to develop
new products that compete with our products.
Government Regulation
ArteFill is classified as a medical device and is subject to
extensive and rigorous regulation by the FDA, as well as by
other federal and state regulatory bodies in the United States
and comparable authorities in other countries. FDA regulations
govern the following activities that we perform, or that are
performed on our behalf, to ensure that medical products
distributed domestically or exported internationally are safe
and effective for their intended uses:
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product design, development and manufacture; |
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product safety, clinical testing, labeling and storage; |
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pre-marketing clearance or approval; |
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record-keeping procedures; |
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product marketing, sales and distribution; and |
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post-marketing surveillance, reporting of deaths or serious
injuries and medical device reporting. |
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FDAs Pre-market Clearance and Approval Requirements |
Unless an exemption applies, each medical device we wish to
distribute commercially in the United States will require
either prior 510(k) clearance or PMA from the FDA. Medical
devices are classified into one of three classes
Class I, Class II, or Class III
depending on the degree of risk associated with each medical
device and the extent of control needed to ensure safety and
effectiveness. Devices deemed to pose lower risks are placed in
either Class I or II, which requires the manufacturer
to submit to the FDA a
pre-market notification
requesting permission to commercially distribute the device.
This process is generally known as 510(k) clearance. Some low
risk devices are exempted from this requirement. Devices deemed
by the FDA to pose the greatest risk, such as life-sustaining,
life-supporting or implantable devices like ArteFill, or devices
deemed not substantially equivalent to a previously cleared
510(k) device, are placed in Class III, requiring PMA.
ArteFill is a Class III device that required approval of a
PMA application.
When a 510(k) clearance is required, we must submit a pre-market
notification to the FDA demonstrating that our proposed device
is substantially equivalent to a previously cleared and legally
marketed 510(k) device or a device that was in commercial
distribution before May 28, 1976 for which the FDA has not
yet called for the submission of a PMA application. By
regulation, the FDA is required to clear or deny a 510(k)
pre-market notification within 90 days of submission of the
application. As a practical matter, clearance often takes
significantly longer. The FDA may require further information,
including clinical data, to make a determination regarding
substantial equivalence. If the FDA determines that the device,
or its intended use, is not substantially equivalent to a
previously cleared device or use, the FDA will place the device,
or the particular use, into Class III. We currently do not
have any products in development that would qualify for 510(k)
clearance.
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Pre-market Approval Pathway |
A PMA application must be submitted to the FDA if the device
cannot be cleared through the 510(k) process. The PMA
application process is much more demanding and uncertain than
the 510(k) pre-market
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notification process. A PMA application must be supported by
extensive data, including but not limited to technical,
preclinical, clinical trials, manufacturing and labeling to
demonstrate to the FDAs satisfaction the safety and
effectiveness of the device. After a PMA application is
submitted and the FDA determines that the application is
sufficiently complete to permit a substantive review, the FDA
will accept the application for review. The FDA has
180 days to review an accepted PMA application,
although the review of an application generally occurs over a
significantly longer period of time and can take up to several
years. During this review period, the FDA may request additional
information or clarification of the information already
provided. Also, an advisory panel of experts from outside the
FDA may be convened to review and evaluate the application and
provide recommendations to the FDA as to the approvability of
the device. In addition, the FDA will conduct a pre-approval
inspection of the manufacturing facility to ensure compliance
with QSRs. New PMA applications or PMA application supplements
are required for a significant modification to the manufacturing
process, labeling and design of a device that is approved
through the PMA process. PMA supplements often require
submission of the same type of information as a PMA application,
except that the supplement is limited to information needed to
support any changes from the device covered by the original PMA
application and may not require as extensive clinical data or
the convening of an advisory panel. FDA review of most PMA
applications and PMA supplements is subject to payment of a user
fee, ranging from $18,000 to $259,000 (in fiscal year 2006),
with reduced fees applicable to small business concerns.
Clinical trials are almost always required to support a PMA
approval and are sometimes required for 510(k) clearance. In the
United States, these trials generally require submission of an
application for an Investigational Device Exemption, or IDE, to
the FDA. The IDE application must be supported by appropriate
data, such as animal and laboratory testing results, showing
that it is safe to test the device in humans and that the
testing protocol is scientifically sound. The IDE must be
approved in advance by the FDA for a specific number of patients
unless the product is deemed a non-significant risk device
eligible for more abbreviated IDE requirements. Clinical trials
for significant risk devices may not begin until the IDE
application is approved by the FDA and the appropriate
institutional review boards, or IRBs, at the clinical trial
sites. Our clinical trials must be conducted under the oversight
of an IRB at the relevant clinical trial sites and in accordance
with FDA regulations, including but not limited to those
relating to good clinical practices. We are also required to
obtain patients informed consent that complies with both
FDA requirements and state and federal privacy regulations. We,
the FDA or the IRB at each site at which a clinical trial is
being performed may suspend a clinical trial at any time for
various reasons, including a belief that the risks to study
subjects outweigh the benefits. Even if a trial is completed,
the results of clinical testing may not demonstrate the safety
and efficacy of the device, may be equivocal or may otherwise
not be sufficient to obtain approval of the product. Similarly,
in Europe the clinical study must be approved by the local
ethics committee and in some cases, including studies with
high-risk devices, by the Ministry of Health in the applicable
country.
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Regulatory Status of ArteFill |
In April 2002, we submitted to the FDA a PMA application for our
product candidate. We initially named the product used in our
clinical trials as Artecoll, but later changed the name of our
product candidate to ArteFill to reflect refinements that we
made to the PMMA microsphere manufacturing process. In February
2003, an independent expert advisory panel on general and
plastic surgery devices recommended that our PMA application be
considered approvable. The FDA adopted the recommendations of
the panel, and in January 2004 the FDA issued a letter informing
us that our PMA application was approvable, subject to the
fulfillment of two conditions. The first condition to approval
required us to demonstrate that we can manufacture the bovine
collagen component of ArteFill at a dedicated manufacturing
facility according to FDA quality requirements. The second
condition to approval was the submission of a post-market study
protocol for examining the potential incidence of delayed
granuloma formation in patients treated with ArteFill. A
granuloma is an inflammatory reaction to a foreign body that
results in redness and hardening of tissue at the injection
site. Granuloma formation has been reported to occur in patients
treated with all dermal fillers. In the case of temporary dermal
fillers, this condition can dissipate when these fillers
68
biodegrade and are reabsorbed by the body. In the case of
ArteFill, which is a non-resorbable aesthetic injectable implant
containing PMMA microspheres that will not be absorbed or
degraded by the human body, it is believed that granuloma
formation could occur at any time after injection, although we,
the FDA and the medical community currently do not have
long-term data regarding the incidence rate of granuloma
formation in patients treated with ArteFill. As a result, the
FDA has required us to conduct this post-market study to examine
whether treatment with ArteFill affects the incidence rate of
granuloma formation. We are required to identify the methods by
which we will monitor approximately 1,000 patients for
granuloma formation for a period of five years after the date of
their initial treatment. The FDA has informed us that our
proposed protocol is acceptable.
In January 2006, we submitted an amendment to our PMA
application to address the conditions set forth in the
FDAs approvable letter. In March 2006, the FDA completed
inspections of our manufacturing facility and our contract
sterilizer in Frankfurt, Germany, with no observations noted. In
addition, the FDA completed a comprehensive pre-approval
inspection of our primary manufacturing facility in
San Diego, California, in April 2006. During this
inspection, the FDA noted four minor observations, all of which
were corrected and annotated to the inspection report as
corrected. On May 3, 2006, the FDA issued an EIR,
indicating that its inspection of our manufacturing facilities
was completely closed, requiring no further action on the part
of our company related to the inspection. On October 27,
2006, the FDA approved ArteFill for the correction of facial
wrinkles known as smile lines, or nasolabial folds.
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Pervasive and Continuing Regulation |
After a device is placed on the market, numerous regulatory
requirements continue to apply. These include:
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the FDAs QSRs, which requires manufacturers, including
third-party manufacturers, to follow stringent design, testing,
control, documentation and other quality assurance procedures
during all aspects of the manufacturing process; |
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labeling regulations and FDA prohibitions against the promotion
of products for uncleared, unapproved or off-label uses; |
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clearance or approval of product modifications that could
significantly affect safety or efficacy or that would constitute
a major change in intended use; |
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medical device reporting, or MDR, regulations, which require
that manufacturers report to the FDA if their device may have
caused or contributed to a death or serious injury or
malfunctioned in a way that would likely cause or contribute to
a death or serious injury if the malfunction were to
recur; and |
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post-market surveillance regulations, which apply when necessary
to protect the public health or to provide additional safety and
effectiveness data for the device. |
We have registered with the FDA as a medical device manufacturer
and have applied for a manufacturing license from the California
Department of Health Services, or CDHS. We are subject to
unannounced inspections by the FDA and the Food and Drug Branch
of CDHS, or FDB, to determine our compliance with the QSR and
other regulations, and these inspections may include the
manufacturing facilities of our suppliers. Failure to comply
with applicable regulatory requirements can result in
enforcement action by the FDA, which may include any of the
following sanctions:
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warning letters, fines, injunctions, consent decrees and civil
penalties; |
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repair, replacement, refunds, recall or seizure of our products; |
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operating restrictions, partial suspension or total shutdown of
production; |
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refusing our requests for 510(k) clearance or PMA of new
products, new intended uses or modifications to existing
products; |
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withdrawing 510(k) clearance or PMAs that have already been
granted; and |
69
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ArteFill Instructions for Use |
In connection with approving our PMA application for ArteFill,
the FDA also reviewed and approved our Instructions for Use of
ArteFill, or our product label. Our product label provides that
ArteFill is indicated for the correction of nasolabial folds in
the general population, but is contraindicated for use in
patients that:
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have a positive reaction to our ArteFill skin test; |
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have a history of severe allergies manifested by a history or
presence of multiple severe allergies; |
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are allergic or hypersensitive to the anesthetic lidocaine
contained in ArteFill; |
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have a history of allergies to any bovine collagen products; |
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are prone to thick scar formation and/or excessive scarring; or |
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are undergoing or planning to undergo desensitization injections
to meat products. |
ArteFill also is contraindicated for augmentation in the body of
the lip.
Our product label further provides that ArteFill should not be
used in patients that have skin outbreaks near the injection
site until any outbreak clears and cautions that patients may
experience increased bruising or bleeding at the injection site
if they are taking aspirin or anti-inflammatory drugs or have
any medical condition that affects their blood. In addition,
physicians, in order to help their patients make an informed
treatment decision, should ask patients if they:
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have had any treatments for smile lines in the last
6 months; |
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are receiving ultra-violet light therapy; or |
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are currently on immuno-suppressive medications or are suffering
from any skin disease. |
The product label also provides that the most common adverse
events associated with ArteFill injections, similar to those
observed with other dermal fillers, are lumpiness, persistent
swelling or redness and increased sensitivity at the injection
site.
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Promotion and Advertising Restrictions |
We may promote and advertise ArteFill only for the correction of
nasolabial folds. We are also limited to promoting the efficacy
benefits of ArteFill for six months. However, physicians may
prescribe ArteFill for uses that are not described in its
FDA-approved labeling
and for uses that differ from those tested by us and approved by
the FDA. Such off-label uses are common across medical
specialties. Physicians may believe that such off-label uses are
the best treatment for many patients in varied circumstances.
The FDA does not regulate the behavior of physicians in their
choice of treatments. The FDA does, however, strictly prohibit a
manufacturers communications regarding off-label uses.
Companies cannot actively promote
FDA-approved devices
for off-label uses. If the FDA believes we are promoting
ArteFill for off-label uses, we could be subject to negative
publicity, warning letters, fines, civil and criminal penalties,
injunctions and product seizures.
As a manufacturer of Class III medical devices, our
manufacturing processes and facilities are subject to regulation
and review by international regulatory agencies for products
sold internationally. A medical device may only be marketed in
the European Union, or the EU, if it complies with the Medical
Devices Directive (93/42/ EEC), or the MDD, and bears the CE
mark as evidence of that compliance. To achieve this, the
medical devices in question must meet the essential requirements
defined under the MDD relating to safety and performance, and we
as manufacturer of the devices must undergo verification of our
regulatory compliance by a third party standards certification
provider, known as a notified body. In January 2006, we
70
received a quality system certificate from a notified body,
demonstrating our compliance with ISO 13485:2003, the
internationally recognized quality system standard for medical
device manufactures. The ISO 13485:2003 certificate
represents the first step toward demonstrating compliance with
the appropriate medical and statutory requirements for receipt
of the CE mark in the EU and for marketing approval in Canada.
After establishing ArteFill in the United States, we plan to
explore opportunities to register and sell ArteFill in selected
international markets, which would require us to apply for the
CE mark and other foreign regulatory approvals. The regulation
of our product outside of the United States varies by country.
For instance, in Canada and Mexico, ArteFill would be regulated
as a medical device, and we may submit for regulatory
authorization to commercialize ArteFill in both Canada and
Mexico. Certain countries may regulate our product as a
pharmaceutical product, which would require us to make extensive
filings and obtain regulatory approvals before
commercialization. Certain other countries may restrict its
import or sale. Other countries have no applicable regulations
regarding the import or sale of products similar to ours,
creating uncertainty as to what standards we may be required to
meet.
Our present and future business has been and will continue to be
subject to various other laws and regulations, including state
and local laws relating to such matters as safe working
conditions and disposal of potentially hazardous substances.
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State and Federal Physician and Healthcare Regulation |
Physicians are also subject to various state laws and
regulations that govern the practice of medicine, prohibit
physicians from accepting payment or remuneration for patient
referrals or goods or services, restrict referrals for certain
services where a physician has a financial relationship with an
entity to whom referrals are made, and mandate certain
disclosure requirements for physicians who refer patients to
organizations with whom physicians have a significant beneficial
interest. These laws include those known as anti-kickback laws
and physician self-referral laws. Violations of these laws can
lead to fines, civil monetary penalties, incarceration and other
administrative sanctions by state or federal agencies. We intend
to educate our employees and independent contractors regarding
these rules and regulations, and to comply with all applicable
laws, rules and regulations that may govern the relationships
between us and the physicians or healthcare organizations who
purchase or administer ArteFill to their patients.
Clinical History
ArteFill is the culmination of more than 20 years of
research and development. In 1999, we acquired the
U.S. intellectual property rights to ArteFill. In 2004, we
acquired all other remaining worldwide intellectual property
rights related to ArteFill. These rights included (i) the
know-how and trade secrets associated with the bovine collagen
manufacturing process used to produce ArteFill and (ii) the
know-how, trade secrets and certain assets, including a
manufacturing facility in Frankfurt, Germany, relating to the
manufacture of the PMMA microspheres contained in ArteFill.
Following our acquisition of this technology, we have made
further refinements to the PMMA manufacturing process that we
believe improve the characteristics and purity of the PMMA
microspheres. In addition, to meet the FDAs requirements
for final marketing approval of our PMA application and to
prepare for commercialization in the United States, we have
established our own dedicated QSR compliant manufacturing
facility in San Diego, California to produce the bovine
collagen used in ArteFill and to complete the manufacturing,
packaging and labeling processes for ArteFill.
To support our PMA application, we completed a double-blind,
prospective, controlled, randomized, multi-center clinical trial
in the United States in 2001. In this trial, patients were
randomized (1:1) either to receive ArteFill, or to receive
either Zyderm or Zyplast, the leading bovine collagen-based
temporary dermal fillers, as a control. A total of 251 subjects
(128 ArteFill, 123 control) were treated at eight dermatology or
plastic surgery centers in the United States.
Follow-up periods for
both safety and efficacy were at one, three and six months.
Patients treated with ArteFill were also evaluated at 12 months.
71
The primary effectiveness endpoint was a comparison of the
cosmetic correction provided by ArteFill versus the control
treatments at the end of a six-month period after injection. The
cosmetic correction was evaluated by means of a validated Facial
Fold Assessment Scale, or FFA Scale, using standardized
photographs as reference. The numerical values for the FFA Scale
are presented in the table below.
Facial Fold Assessment Scale Ratings
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Score | |
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Description |
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Depth (mm) | |
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0 |
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No folds |
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1 |
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Folds just perceptible |
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0.1 |
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2 |
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Shallow folds with some defined edges |
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0.2 |
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3 |
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Moderately deep folds with some well-defined edges |
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0.5 |
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4 |
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Deep folds with most edges well-defined and some redundant folds |
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1.0 |
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5 |
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Very deep folds with most edges well-defined and some redundant
folds |
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2.0 |
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Comparisons to the standardized reference photos were made by
masked observers at pre-treatment and at
follow-up visits at one
month, three months and six months after treatment. FFA Scale
improvement was determined by subtracting each patients
FFA score on the applicable evaluation date from the
patients FFA score prior to treatment. Safety was
evaluated by comparing the incidence and severity of adverse
clinical events during and for 12 months after treatment.
A total of 229 women and 22 men between the ages of 28 and 82
(mean 52.2 years) were enrolled in the study. There were no
significant differences in the distribution of age, gender and
the facial area treated for the two treatment groups. At six
months after treatment, the mean FFA score improvement in
subjects who received ArteFill for the treatment of nasolabial
folds was 0.8, as compared to a mean FFA score improvement of
0.0 among subjects who received the collagen control treatments.
This difference in the level of FFA score improvement in the two
groups was statistically significant (p<0.001). The
difference between the treatments as measured by the improvement
in FFA score from baseline was evident beginning three months
after treatment.
In addition, the nasolabial fold area showed significantly
greater improvement for subjects treated with ArteFill at 12
months than for subjects treated with collagen control at six
months, consistent with the comparison of the two treatment
groups at six months. There were no statistically significant
differences between the ArteFill and control groups for
treatment of glabellar folds, or frown lines, upper lip lines or
mouth corners at six months after treatment. The following graph
represents results from our clinical trial comparing ArteFill
and Zyderm or Zyplast, based on FFA scale improvement over six
months.
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At six months after treatment, which was the primary efficacy
evaluation endpoint, the wrinkle correction in the patients
treated with ArteFill persisted, while the patients treated with
the collagen returned to their pre-treatment status. At the
six-month evaluation, the control group subjects were offered
the opportunity to be treated with ArteFill. Of the 123 subjects
in the original control group, 116 completed the
six-month evaluation
and were offered ArteFill as a crossover treatment. Of these,
106 (91%) chose to be treated with ArteFill. In the
111 patients who were treated with ArteFill and remained in
the study at 12 months after treatment, ArteFill
demonstrated continued safety and wrinkle correction. We did not
evaluate the patients who received the collagen control at
12 months after treatment because these patients had either
elected to be treated with ArteFill at their six-month
evaluation period or had returned to their pre-treatment status.
There were no unexpected or serious adverse events reported in
patients treated with ArteFill in the clinical trial. Adverse
events reported for ArteFill were similar to but lower in number
than the adverse events reported for the control group.
Throughout the clinical trial, there were no significant
differences in the adverse event rates reported for the two
treatments. Based on the results of our clinical trial, on
October 27, 2006 the FDA approved ArteFill for the
correction of nasolabial folds.
Prior to commencing our U.S. clinical trial, we conducted
an open label, multi-center, single-arm clinical trial study
under a conditional FDA IDE approval. The purpose of this study
was to assess the safety of ArteFill for the correction of soft
tissue defects in the face. A total of 157 subjects were
enrolled and were monitored at three, six and 12 months
post-treatment. 126 of the 157 (80.2%) subjects completed the
one-year study. There were no implant-related severe illness,
trauma or death among the subjects treated with ArteFill. A
total of 18 adverse events in 17 subjects were reported, most of
which were mild to moderate events. Only one severe adverse
event related to treatment with ArteFill was reported. The
adverse event, a granuloma, was treated with Cipro and, later,
surgical excision of the implant. The only other severe adverse
event reported in the study resulted from use of the product in
a manner contrary to the study protocol.
In our U.S. clinical trial we evaluated patients for
12 months after treatment. This evaluation showed that
aesthetic benefits of ArteFill persisted and safety remained
throughout the one-year study period. Based on this data, the
FDA has determined that ArteFill is safe and effective and has
allowed us to characterize it as a non-resorbable aesthetic
injectable implant. We believe that the aesthetic effects of
ArteFill may last for many years.
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We currently lack published long-term clinical data for
completed trials supporting the aesthetic benefits of ArteFill
beyond six months. However, we are currently conducting ongoing,
five-year follow-up
evaluations of patients who received ArteFill in the
U.S. clinical trial and who qualify for long-term
follow-up. When completed, we intend to submit the results of
these five-year
follow-up evaluations
to the FDA and to a peer-reviewed scientific journal for
publication. The evaluation of the first 69 patients
indicates that these patients have experienced sustained
aesthetic improvements five years after initial treatment with
ArteFill and express high levels of satisfaction with ArteFill
treatment. Dr. Steven Cohen, the lead investigator in our
U.S. clinical trial, presented preliminary findings of the
five-year follow-up
study, which included the results of evaluations for
69 patients, at a conference of the American Society of
Plastic Surgeons held in San Francisco, California in October
2006. These interim data for the 69 patients have also been
published in the September 1, 2006 supplement to Plastic
and Reconstructive Surgery, a peer-reviewed journal.
Research and Development
We incurred research and development expenses of
$1.0 million, $3.6 million and $10.2 million in
fiscal 2003, 2004 and 2005, respectively, and $5.7 million
in the first nine months of 2006, primarily related to the
development of our manufacturing processes for ArteFill. We
currently plan to conduct limited research and clinical
development activities to explore potential improvements and
enhancements to ArteFill for aesthetic applications. We also
plan to explore applications of our injectable microsphere
platform technology in non-aesthetic medical applications
through collaborative arrangements with strategic partners.
These fields may include gastroesophageal reflux disease, female
stress urinary incontinence, spinal disc degeneration, sleep
apnea and snoring.
Intellectual Property
We rely on a combination of patent, trademark, copyright, trade
secret and other intellectual property laws, nondisclosure
agreements and other measures to protect our proprietary rights.
We currently hold five issued U.S. patents, and have seven
pending U.S. patent applications. We also have five issued
foreign patents, and multiple foreign patent applications
pending in Australia, Canada, Japan, Mexico and Europe. Our
primary U.S. patent, No. 5,344,452, which we refer to
as the 452 patent, covers our product, ArteFill, and does
not expire until September 2011. We have applied for an
extension of the term of the 452 patent with the
U.S. Patent and Trademark Office, or the U.S. PTO,
under Title II of the Drug Price Competition and Patent
Term Restoration Act. If the U.S. PTO grants our
application, the term of the 452 patent may potentially be
extended until September 2016. Our other four U.S. patents
have projected expiration dates from April 2, 2021 through
February 6, 2023. These other patents are primarily related
to injection devices, but do not currently cover or provide
patent protection for ArteFill. These other patents may provide
patent protection for future products, primarily in the
gastroenterology and urology areas. The foreign patents that are
counterparts to the 452 patent expire in December 2009. We
believe that our 452 patent family protects our rights to
ArteFill in the United States, Austria, Belgium, France,
Germany, Hong Kong, Italy, Liechtenstein, Luxembourg, the
Netherlands, Singapore, Spain, Sweden, Switzerland and the
United Kingdom. We also have an Australian patent covering an
injection device.
We have obtained registrations for the trademarks ArteFill,
Artes, Artes Medical and Enduring Beauty in the United States
and certain foreign jurisdictions. In addition, we have filed an
application to register the trademark The Art of Soft Tissue
Augmentation in the United States and certain foreign
jurisdictions, and we have filed applications to register the
trademark The First to Last in the United States. All of these
applications are pending.
We also rely on trade secrets, technical know-how, contractual
arrangements and continuing innovation to protect our
proprietary technology and maintain our competitive position. We
seek to protect our proprietary information and other
intellectual property by requiring our employees, consultants,
contractors, outside scientific collaborators and other advisors
to execute non-disclosure and invention assignment agreements on
commencement of their employment or engagement.
74
In October 2005, in connection with the settlement of all
outstanding disputes and litigation matters among us, BioForm
Medical, Inc. and BioForm Medical Europe, B.V., we granted to
the BioForm entities an exclusive, world-wide, royalty-bearing
license under certain of our patents to make and sell implant
products containing CaHA particles, and a non-exclusive,
world-wide, royalty-bearing license under the same patents to
make and sell certain other non-polymeric implant products. See
Material Agreements above.
Employees
As of November 27, 2006, we had 109 full-time
employees, including six full-time employees located in
Frankfurt, Germany. In the United States, we have
23 manufacturing employees, 17 quality assurance and
regulatory employees, 34 sales and marketing employees,
including 19 direct sales professionals, nine employees in
research and development and 20 general and administrative
employees. None of our employees are covered by a collective
bargaining agreement, and we consider our relationship with our
employees to be good.
Our management team has recently undergone several changes. At a
board meeting held on October 26, 2006, our board of
directors determined that it was in the best interests of our
company and our stockholders to remove Dr. Stefan M.
Lemperle from his position as our Chief Executive Officer. This
decision by our board of directors was based on the unanimous
recommendations of our audit and nominating and corporate
governance committees, which are comprised of our independent
non-employee directors, presented to the board on
October 2, 2006. On November 17, 2006, we entered into
a separation agreement and general release with Dr. Stefan
Lemperle, pursuant to which he resigned as a member of our board
of directors and as an employee.
Following discussions at a series of weekly board meetings in
October 2006, our board approved a plan on October 26, 2006
to reduce our operating costs and to reorganize our business
operations, including our sales and marketing organization, to
focus our efforts on the U.S. market and on physician-based
training and sales programs. In connection with this cost
reduction plan and reorganization, we terminated the employment
of William von Brendel, our former Vice President of Worldwide
Sales and International Markets, Harald T. Schreiber, our former
Chief Creative Officer, and a manager in our sales and marketing
organization on October 27, 2006.
In connection with their termination, we believe we have paid
all amounts owed to Messrs. von Brendel and Schreiber under the
terms of their employment agreements. On the date of their
termination, we also offered to pay Messrs. von Brendel and
Schreiber three months severance and to extend the
expiration date of their respective stock options from
90 days to one year after the date of termination of their
employment, in exchange for their execution of a general
release. As discussed below under Legal
Proceedings, Mr. Schreiber filed a demand for
arbitration against us on November 2, 2006 and Mr. von
Brendel filed a demand for arbitration against us on
November 16, 2006.
Facilities
We lease a 35,000 square foot building for our corporate,
manufacturing and research and development headquarters in
San Diego, California under a seven-year lease that expires
in December 2011. Our facility includes 14,000 square feet
of clean room space, 15,000 square feet of manufacturing,
support and laboratory space and 6,000 square feet of
administrative office space. We have the first right of refusal
to purchase the facility during the term of the lease, as well
as the right to extend the lease term for an additional
5 years. We also sublease 8,000 square feet of
additional office space in an adjacent building under a six-year
sublease that expires in March 2011. In addition, we lease a
1,750 square foot manufacturing facility in Frankfurt,
Germany, where we manufacture the PMMA microspheres used
exclusively in ArteFill. The lease for our Frankfurt facility
had an initial term of three years and is subject to automatic
one-year extensions unless written notice of termination is
given by either party at least six months prior to the beginning
of the extension term. We believe that our existing facilities
are adequate to meet our needs for the foreseeable future.
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Legal Proceedings
In August 2005, Elizabeth Sandor, an individual residing in
San Diego, California, filed a complaint against us,
Drs. Gottfried Lemperle, Stefan Lemperle and Steven Cohen
in the Superior Court of the State of California for the County
of San Diego. The complaint, as amended, set forth various
causes of action against us, including product liability, fraud,
negligence and negligent misrepresentation, and alleged that
Dr. Gottfried Lemperle, our co-founder, former Chief
Scientific Officer and a former member of our board of
directors, treated Ms. Sandor with Artecoll and/or ArteFill
in violation of medical licensure laws, that the product was
defective and unsafe because it had not received FDA approval at
the time it was administered to Ms. Sandor, and that
Ms. Sandor suffered adverse reactions as a result of the
injections. In addition, the complaint alleged that
Dr. Gottfried Lemperle and his son, Dr. Stefan Lemperle,
our other co-founder, former Chief Executive Officer and a
former director, falsely represented to her that the product had
received an approvability letter from the FDA and was safe and
without the potential for adverse reactions. The complaint also
alleged medical malpractice against Dr. Cohen, the lead
investigator in our U.S. clinical trial, for negligence in
treating Ms. Sandor for the adverse side effects she
experienced. Ms. Sandor sought damages in an unspecified
amount for pain and suffering, medical and incidental expenses,
loss of earnings and earning capacity, punitive and exemplary
damages, reasonable attorneys fees and costs of
litigation. On June 1, 2006, the parties filed a
stipulation to dismiss the case without prejudice and toll the
statute of limitations. The case was dismissed on June 5,
2006, and the plaintiff is allowed to refile the case at any
time within 18 months from that date.
During our recent negotiations with the parties involved in the
Sandor litigation, Dr. Gottfried Lemperle informed us that
his counsel had contacted an investigator in the FDAs
Office of Criminal Investigations to determine whether any
investigation of Dr. Gottfried Lemperle was ongoing. In
March 2006, Dr. Gottfried Lemperles counsel informed
us that an investigator at the FDA informed her that the FDA has
an open investigation regarding us, Dr. Gottfried Lemperle
and Dr. Stefan Lemperle, that the investigation had been
ongoing for many months, that the investigation would not be
completed within six months, and that at such time the
investigation is completed, it could be referred to the U.S.
Attorneys Office for criminal prosecution. In November
2006, we contacted the FDAs Office of Criminal
Investigation. That office confirmed the ongoing investigation,
but declined to provide any details of the investigation,
including the timing, status, scope or targets of the
investigation.
To our knowledge, prior to, or following this inquiry, neither
Dr. Gottfried Lemperle, Dr. Stefan Lemperle nor any of our
current officers or directors has been contacted by the FDA in
connection with an FDA investigation. As a result, we have no
direct information from the FDA regarding the subject matter of
this investigation. We believe that the investigation may relate
to the facts alleged in the Sandor litigation and the following
correspondence from and to the FDA. In July 2004, we received a
letter from the FDAs Office of Compliance indicating that
the FDA had received information suggesting that we may have
improperly marketed and promoted ArteFill prior to obtaining
final FDA approval. In addition, we received a letter from the
FDAs MedWatch program, the FDAs safety information
and adverse event reporting program, on April 21, 2005,
which included a Manufacturer and User Facility Device
Experience Database, or MAUDE, report. The text of the MAUDE
report contained facts similar to those alleged by the plaintiff
in the Sandor litigation.
We responded to the FDAs correspondence in August 2004 and
again in May 2006. In our responses, we informed the FDA that
based on our internal investigations, Dr. Gottfried
Lemperle had used Artecoll, a predecessor product to ArteFill,
on four individuals in the United States. Artecoll has been
manufactured and sold by third parties outside the United States
under a CE mark since 1996. In 2004, we acquired all worldwide
intellectual property rights related to Artecoll. Following this
acquisition, we requested these third parties to cease
manufacturing their product named Artecoll. We currently do not
manufacture, and we have never manufactured, distributed or
received any revenues from Artecoll. We initially named the
product used in our clinical trials as Artecoll, but later
changed the name of our product candidate to ArteFill to reflect
refinements that we have made to the PMMA microsphere
manufacturing process following our acquisition of the rights to
Artecoll.
76
We stated in our correspondence to the FDA that we found no
evidence that any of the Artecoll used in the U.S. clinical
study was used improperly before or after receipt of the
approvable letter from the FDA in January 2004. We also informed
the FDA that we could not conclusively determine the source of
the Artecoll used on these individuals, that Dr. Gottfried
Lemperles use of Artecoll was not part of a study or any
activity sponsored by us and that Dr. Gottfried Lemperle
had resigned from his position as Chief Scientific Officer and
as a member of our board of directors. In addition to our
correspondence to the FDA, we also informed the FDA of these
matters during its inspection of our manufacturing facilities in
San Diego, California in April 2006. In May 2006, we
received the FDAs EIR for its investigation of our San
Diego manufacturing facility. The EIR referenced two anonymous
consumer complaints received by the FDA. The first complaint,
received by the FDA in December 2003, alleges that Dr. Stefan
Lemperle promoted the unapproved use of ArteFill, providing,
upon request, a list of local doctors who could perform
injections of ArteFill. The second complaint, received by the
FDA in June 2004, alleges complications experienced by an
individual who had been injected with ArteFill by Dr. Gottfried
Lemperle in his home. The second complaint further alleges that
Dr. Stefan Lemperle marketed unapproved use of ArteFill. In May
2006, we terminated Dr. Gottfried Lemperles
consulting relationship with us. Dr. Gottfried Lemperle no
longer provides services to us in any capacity. In October 2006,
our board of directors removed Dr. Stefan Lemperle from the
position of Chief Executive Officer, and in November 2006, Dr.
Stefan Lemperle resigned as a director and employee.
Dr. Stefan Lemperle no longer provides services to us in
any capacity.
In July 2006, the FDA requested us to submit an amendment to our
pre-market approval application for ArteFill containing a
periodic update covering the time period between
January 16, 2004, the date of our approvable letter, and
the date of the amendment. The FDA requested our periodic update
to include, among other things, all information available to us
regarding individuals who had been treated with Artecoll outside
our clinical trials and any adverse events these individuals had
experienced. In response to this request, we completed
additional inquiries regarding Dr. Gottfried
Lemperles unauthorized uses of Artecoll outside our
clinical trials in contravention of FDA rules and regulations.
In August 2006, we filed an amendment to our pre-market approval
application that included the periodic update requested by the
FDA. In the amendment, we informed the FDA that as a result of
our additional inquiries, we had identified nine individuals who
had been treated with Artecoll in the United States by
Dr. Gottfried Lemperle, four of whom we had disclosed to
the FDA in our prior correspondence. We also informed the FDA
that 16 individuals had been treated with Artecoll by
physicians in Mexico or Canada, where Artecoll is approved for
treatment, in connection with physician training sessions
conducted in those countries. Further, we informed the FDA that
Dr. Stefan M. Lemperle, our then serving Chief Executive
Officer and director, had been injected with Artecoll in the
United States in 2004 by his father, Dr. Gottfried
Lemperle. Prior to the time we conducted the additional
inquiries to prepare our periodic update for the FDA,
Dr. Stefan M. Lemperle had failed to disclose to us, and to
the FDA, that he had been injected with Artecoll in
contravention of FDA rules and regulations. In October 2006, our
board of directors removed Dr. Stefan Lemperle from the
position of Chief Executive Officer, and in November 2006, Dr.
Stefan Lemperle resigned as a director and employee.
Dr. Stefan Lemperle no longer provides services to us in
any capacity. We received FDA approval to market ArteFill on
October 27, 2006.
On November 6, 2006, we filed a demand for arbitration with
the American Arbitration Association against Melvin Ehrlich, who
from January 15, 2004 through April 5, 2004, was our
President and Chief Operating Officer. In the arbitration, we
are seeking declaratory relief regarding the number of shares of
common stock Mr. Ehrlich is entitled to purchase under a
warrant we issued to him in connection with his employment
agreement. We believe Mr. Ehrlich vested in and, therefore,
is entitled to purchase 26,070 shares of common stock based on
the length of time he provided services to our company. These
warrant shares have an exercise price of $4.25 per share, and
are subject to a 180-day market standoff period in connection
with our proposed offering. Mr. Ehrlich contends that he is
entitled to purchase up to 470,588 shares of common stock, at an
average exercise price of $7.44 per share, contingent upon our
satisfaction of certain milestones, including the FDAs
approval of ArteFill, the FDAs certification of our
manufacturing facilities and the completion of this offering. He
claims that the language in the warrant allows him to continue
to vest in the warrant shares after his employment with us
ended, regardless of whether he provided any assistance to the
Company to satisfy the milestones set forth in the warrant. We
reject this interpretation
77
of the warrant, and plan to vigorously pursue our request for
declaratory relief and to defend against any claims
Mr. Ehrlich asserts. The hearing is expected to be held in
San Diego, California.
In October 2006, we made a number of changes in our management
team. On October 27, 2006, we terminated the employment of
Harald T. Schreiber, our former Chief Creative Officer, and
William von Brendel, our former Vice President
Worldwide Sales and International Markets, in accordance with
the terms of their written employment agreements with us and in
connection with a cost reduction plan and a reorganization of
our business operations, including our sales and marketing
organization, to focus on the U.S. market and physician-based
training and sales programs. On November 2, 2006, we were
served with a demand for arbitration with the American
Arbitration Association by Mr. Schreiber pursuant to the
dispute resolution provisions in his employment agreement.
Mr. Schreiber seeks compensatory damages of an unspecified
amount and alleges several causes of action, including wrongful
termination, fraud, breach of contract and the implied covenant
of good faith and fair dealing, and hostile work environment. We
believe that many of Mr. Schreibers claims contradict
the terms of his employment agreement, and we deny his
allegations. To avoid the cost of arbitration, we have issued a
settlement offer to Mr. Schreiber. There can be no assurance
that our offer will be acceptable to Mr. Schreiber, or that we
will reach a settlement with Mr. Schreiber. If we do not
reach an agreement with Mr. Schreiber, we will continue to
defend the case vigorously.
On November 16, 2006, we were served with a demand for
arbitration with the American Arbitration Association by
Mr. von Brendel pursuant to the dispute resolution
mechanism provided in his employment agreement. Mr. von Brendel
seeks compensatory damages of an unspecified amount and alleges
various causes of action, including wrongful termination and
breach of contract, fraud and the implied covenant of good faith
and fair dealing. We deny Mr. von Brendels
allegations and believe that many of his claims contradict the
terms of his employment agreement. To avoid the costs of
arbitration, we have issued a settlement offer to Mr. von
Brendel. There can be no assurance that our offer will be
acceptable to Mr. von Brendel, or that we will reach an
agreement with Mr. von Brendel. If we do not reach an
agreement with Mr. von Brendel, we will defend the case
vigorously.
We maintain employment practices liability insurance in an
amount of up to $2.0 million in the aggregate for claims
made during any one year insurance period. Our insurance carrier
has agreed to provide coverage and defense for these actions,
subject to a customary reservation of rights. We cannot assure
you that our insurance carrier will provide coverage for all
outstanding claims, or any employment related claims asserted in
the future based on our recent management changes, or that any
coverage will be adequate to cover these claims. In addition,
regardless of merit or eventual outcome, our existing actions,
and any potential actions resulting from our recent management
changes, may result in the expenditure of a significant amount
of cash on legal fees, expenses, payment of settlements or
damages. Further, these actions may divert our management
teams time and attention from our business and operations.
78
MANAGEMENT
Executive Officers and Directors
Set forth below are the name, age and position and a brief
account of the business experience of each of our executive
officers and directors as of November 27, 2006.
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Name |
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Age | |
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Position(s) |
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| |
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Christopher J. Reinhard
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52 |
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Executive Chairman of the Board of Directors |
Diane S. Goostree
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50 |
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President and Chief Executive Officer and Director |
Peter C. Wulff
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47 |
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Chief Financial Officer |
Karla R. Kelly, J.D.
|
|
|
52 |
|
|
Chief Legal Officer, General Counsel and Corporate Secretary |
Adelbert L. Stagg, Ph.D.
|
|
|
60 |
|
|
Vice President Regulatory Affairs and Chief
Compliance Officer |
Russell J. Anderson
|
|
|
50 |
|
|
Vice President Product Development &
Engineering |
Larry J. Braga
|
|
|
45 |
|
|
Vice President Manufacturing |
Susan A. Brodsky-Thalken
|
|
|
53 |
|
|
Vice President U.S. Sales and Training |
Frank M. Fazio
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|
|
37 |
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Vice President Marketing |
Daren J. Barone(1)
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|
|
42 |
|
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Director |
John R. Costantino(1)
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|
|
60 |
|
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Director |
Lon E. Otremba(1)
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49 |
|
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Director |
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|
(1) |
Member of the audit committee, compensation committee, and
nominating and corporate governance committee. |
Christopher J. Reinhard has been our Executive Chairman
of the Board of Directors since June 2004. Since December 2003,
Mr. Reinhard has also served as Chairman of the Board and
Chief Executive Officer of Cardium Therapeutics, Inc., a
publicly traded medical technology company. From July 2002 to
December 2004, Mr. Reinhard served as Chief Executive
Officer of Collateral Therapeutics, Inc., a publicly traded
biotechnology company. Prior to the acquisition of Collateral
Therapeutics, Inc. by Schering AG in July 2002,
Mr. Reinhard worked for Collateral Therapeutics in a
variety of roles from June 1995 to July 2002, including Chief
Financial Officer and President. Mr. Reinhard holds a B.S.
in Finance and an M.B.A. from Babson College.
Diane S. Goostree has been our Chief Executive Officer
since November 2006 and our President since March 2006. She also
served as our Chief Operating Officer from March 2006 to
November 2006. From September 2002 to February 2006,
Ms. Goostree was employed with SkinMedica, Inc., a
dermatology specialty pharmaceutical company, most recently
serving as Senior Vice President, Corporate Development and
Operations. From May 2002 to September 2002, Ms. Goostree served
as a consultant for SkinMedica, Inc. From November 2000 to May
2002, Ms. Goostree served as Vice President, Business
Development at Elan Pharmaceuticals, Inc., a publicly traded
biotechnology company. Prior to that, Ms. Goostree worked
for Dura Pharmaceuticals, Inc., a publicly traded pharmaceutical
company, in a variety of roles, including Regional Sales
Director, and most recently as Vice President of Business
Development from September 1995 until its acquisition by Elan
Pharmaceuticals in November 2000. Ms. Goostree holds a B.S.
in Chemical Engineering from the University of Kansas and an
M.B.A. from the University of Missouri in Kansas City.
Peter C. Wulff has been our Chief Financial Officer since
January 2005. From May 2001 to May 2004, Mr. Wulff served
as Vice President Finance, Chief Financial Officer, Treasurer
and Assistant Secretary of CryoCor, Inc., a publicly traded
medical device company. From November 1999 to May 2001,
Mr. Wulff was Chief Financial Officer and Treasurer at
Natural Alternatives International, Inc., a publicly traded and
international nutritional supplement manufacturer.
Mr. Wulff holds a B.A. in both Economics and Germanic
Languages and an M.B.A. in Finance from Indiana University.
Mr. Wulff is also a Certified Management Accountant.
79
Karla R. Kelly, J.D. has been our Chief Legal Officer
since June 2006. Prior to that, she was our Vice President,
Legal Affairs from December 2005 to June 2006. She also has been
our General Counsel and Corporate Secretary since December 2005.
Ms. Kelly has provided legal services to us since 1999.
Prior to joining us, Ms. Kelly practiced out of her own law
firm, Karla R. Kelly, a Professional Law Corporation, from
February 2003 to December 2005. From August 1998 to January
2003, Ms. Kelly practiced as Special Counsel with the law
firm of Luce Forward Hamilton & Scripps LLP in
San Diego, California. Ms. Kelly holds a B.A. in
Nursing from the College of St. Catherine and a J.D. from the
George Washington University National Law Center.
Adelbert L. Stagg, Ph.D. has been our Vice
President, Regulatory Affairs and Chief Compliance Officer since
March 2005. From August 1998 to March 2005, Dr. Stagg
served as Senior Director, Regulatory Affairs of Allergan, Inc.,
a publicly traded pharmaceutical company. In 1999,
Dr. Stagg was the recipient of the Hammer Award
from the Vice President of the United States of America for
industry leadership in working with the FDA. Dr. Stagg
holds a B.A. in both Zoology and History from Andrews University
and a Ph.D. in both Physiology and Pharmacology from Duke
University. He also completed a postdoctoral fellowship in the
department of cardiology at Duke University.
Russell J. Anderson has been our Vice President, Product
Development and Engineering since June 2005. From February 2004
to May 2005, he served as our Vice President, Engineering and
Manufacturing. Mr. Anderson was a Project Engineer at
NuVasive, Inc., a publicly traded medical device company, from
February 2003 to February 2004. From October 2002 to November
2003, Mr. Anderson was also a product development
consultant for Boston Scientific Corp. and Target Therapeutics,
Inc., both publicly traded medical device companies. From April
2001 to October 2002, Mr. Anderson was Director of
Engineering at Novare Surgical Systems, Inc., a privately held
medical device company. Mr. Anderson holds a B.S. in
Environmental Engineering from California Polytechnic State
University and an M.B.A. from California State University in
Hayward.
Larry J. Braga has been our Vice President, Manufacturing
since June 2005 and previously served as Senior Director,
Collagen Manufacturing since June 2004. From April 2000 to May
2004, he served as Director of Manufacturing at Anosys, Inc., a
privately held vaccine development company. From November 1997
to April 2000, Mr. Braga served as Senior Process Engineer
at Cohesion Technologies Inc., a publicly traded medical device
company. Mr. Braga holds a B.S. in biological sciences from
California State University in Hayward. He also holds a
California pharmacy exemptee license.
Susan A. Brodsky-Thalken has been our Vice President,
U.S. Sales and Training since October 2006. From April 2006 to
October 2006, she served as our Executive Director, U.S.
Marketing and Aesthetic Market Development. From February 2003
to April 2006, Ms. Brodsky-Thalken was a principal at AAP, Inc.
providing consulting services to the aesthetic medical device
industry. From April 2002 to January 2003,
Ms. Brodsky-Thalken served as Vice President, Sales of
INAMED Corporation, a publicly traded medical device company.
From February 1995 to March 2002,
Ms. Brodsky-Thalken served as Regional Sales Director for
INAMED Corporation. Ms. Brodsky-Thalken studied Biological
Science at San Francisco State University.
Frank M. Fazio has been our Vice President, Marketing
since June 2006. From March 2005 to May 2006, Mr. Fazio
served as Director, Market Development of INAMED Corporation, a
publicly traded medical device company. From May 2002 to March
2005, Mr. Fazio served as Director, Facial Aesthetics of
INAMED Corporation. From April 2001 to May 2002, Mr. Fazio
was a Principal at AMC Consulting, providing consulting services
to companies in the medical device industry. Mr. Fazio
holds a B.S. in Molecular and Cellular Biology from the
University of Arizona.
Daren J. Barone has been a director since December 2004.
Mr. Barone is Chief Executive Officer of The Barone Group,
a capital management firm specializing in real estate
development and investments. From June 1989 to April 2003,
Mr. Barone was Chief Executive Officer at Watkins
Contracting, Inc., an environmental remediation company.
Mr. Barone is actively involved with the Juvenile Diabetes
Research Foundation and on the board of directors for the USO in
San Diego.
80
John R. Costantino has been a director since June 2006.
Since January 2006, Mr. Costantino has also served as
Managing General Partner of NGN Capital LLC, a venture capital
advisory firm focusing on the healthcare and biotechnology
industries. He has served as Vice President of Walden Capital
Partners L.P., a Small Business Investment Company (SBIC), since
1994, and has been a Managing Director at Walden Partners Ltd.,
a merchant bank providing consulting and investing services,
since 1992. Mr. Costantino currently also serves on the
board of directors of GE Funds, GE Investment Funds, Inc., GE
Institutional Funds and GE LifeStyle Funds, each management
investment companies. Mr. Costantino holds a B.S. from
Fordham University and a J.D. from Fordham Law School. He is
also a Certified Public Accountant.
Lon E. Otremba has been a director since March 2006. He
is the Principal Managing Partner of Lon E. Otremba, Strategic
and Operational Management Advisory, a management advisory firm.
Mr. Otremba most recently served as Chief Executive Officer
and a director of Muzak, LLC, a leading provider of commercial
music services, from September 2003 to July 2005. Prior to
joining Muzak, Mr. Otremba served as Executive Vice
President, Strategic Planning and Operations of the AOL
Interactive Marketing Group of Time Warner, from May 2002 to
August 2003, and as Executive Vice President, Strategic
Planning, of the AOL Time Warner Local Partnership Group from
February 2001 to April 2002. From November 2000 to January 2002,
Mr. Otremba served as Chief Executive Officer and a
director of a privately held technology company.
Mr. Otremba currently also serves on the board of directors
of Cardium Therapeutics, Inc., a publicly traded medical
technology company, and on the board of a non-profit,
independent school in Roslyn, New York. Mr. Otremba holds a
B.A. in marketing and economics from Michigan State University.
Medical/Scientific Advisory Board
We have established a medical/scientific advisory board
consisting of individuals whom we have selected for their
particular expertise in the fields of dermatology, plastic
surgery and cosmetic surgery. We anticipate that our
medical/scientific advisory board members will consult with us
regularly on matters relating to:
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our sales and marketing strategy; |
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our research and development programs; |
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opportunities for strategic collaborations; |
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new technologies relevant to our research and development
programs; and |
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scientific and technical issues relevant to our business. |
Several members of our medical/scientific advisory board are
employed by academic institutions and may have commitments to,
or agreements with, other entities that may limit their
availability to us. Members of our medical/scientific advisory
board may also serve as consultants to other pharmaceutical
and/or
81
medical device companies, including those that may be our
competitors. The following persons are members of our
medical/scientific advisory board:
|
|
|
Name |
|
Specialty |
|
|
|
Harvey Abrams, M.D.
|
|
Dermatology |
Jeffrey Adelglass, M.D.
|
|
Facial Plastic Surgery |
Sassan Alavi, M.D.
|
|
Facial Plastic Surgery |
Fredric Brandt, M.D.
|
|
Dermatology |
Alastair Carruthers, M.D.
|
|
Dermatology |
Jean Carruthers, M.D.
|
|
Cosmetic Surgery |
Paul Chasan, M.D.
|
|
Plastic Surgery |
Steve Fagien, M.D.
|
|
Aesthetic Surgery |
Richard Fitzpatrick, M.D.
|
|
Dermatology |
Miles Graivier, M.D.
|
|
Plastic Surgery |
John Joseph, M.D.
|
|
Cosmetic Surgery |
Rhoda Narins, M.D.
|
|
Dermatology |
Dennis Nigro, M.D.
|
|
Plastic Surgery |
Merrel Olesen, M.D.
|
|
Plastic Surgery |
Marta Rendon, M.D.
|
|
Dermatology |
Mark Rubin, M.D.
|
|
Dermatology |
Thomas L. Tzikas, M.D.
|
|
Facial Plastic Surgery |
Luitgard Wiest, M.D.
|
|
Dermatology |
Upon joining our medical/scientific advisory board, each member
receives a warrant to purchase 5,882 shares of our
common stock at an exercise price equal to the then-current fair
market value, as determined by our board of directors. These
warrants generally have a five-year term and vest in equal
monthly installments over 48 months. In addition to their
initial warrants, we granted an option to purchase
5,882 shares of common stock to Dr. Alastair
Carruthers at an exercise price of $1.49 per share under our
2001 Stock Option Plan in November 2001, we granted to
Dr. Rhoda Narins a warrant to
purchase 5,882 shares of our common stock in March
2006, and we issued 2,352 shares of common stock to
Dr. Mark Rubin in May 2006 in consideration for
extraordinary services as members of our medical/scientific
advisory board. Dr. Narins additional warrant vests
in equal monthly installments over 48 months and has a
five-year term.
Board Composition
Our board of directors currently has five members
Christopher Reinhard (Executive Chairman), Daren Barone, John
Costantino, Diane Goostree and Lon Otremba. Messrs. Barone,
Costantino and Otremba are not, and have never been, employed by
our company or our subsidiary. Our board of directors has
determined that Messrs. Barone, Costantino and Otremba are
independent directors within the meaning of
Rule 4200(a)(15) of the National Association of Securities
Dealers listing standards. Upon the completion of this offering,
our amended and restated certificate of incorporation will
provide that our board of directors will be divided into three
classes, each with staggered three-year terms. At each annual
meeting of stockholders, or special meeting in lieu thereof,
after the initial classification of the board of directors, the
successors to directors whose terms will then expire will be
elected to serve from the time of election and qualification
until the third annual meeting following the election or special
meeting in lieu thereof. This classification of the board of
directors may have the effect of delaying or preventing changes
of control or management. See Description of Capital
Stock Anti-Takeover Provisions of Our Amended and
Restated Certificate of Incorporation and Bylaws and Delaware
Law. Our Class I directors, whose terms will expire at the
2007 annual meeting of stockholders, will be Daren Barone and
Lon Otremba. Our Class II directors, whose terms will expire at
the 2008 annual meeting of stockholders, will be Christopher
Reinhard and John
82
Costantino. Our Class III director, whose term will expire
at the 2009 annual meeting of stockholders, will be Diane
Goostree.
Board Committees
Our board of directors has established an audit committee, a
compensation committee and a nominating and corporate governance
committee. Pursuant to our bylaws, our board of directors may
from time to time establish other committees to facilitate the
management of our business and operations.
Our audit committee consists of Messrs. Barone, Costantino and
Otremba, with Mr. Barone serving as its chair. The audit
committee is responsible for assuring the integrity of our
financial control, audit and reporting functions and reviews
with our management and our independent auditors the
effectiveness of our financial controls and accounting and
reporting practices and procedures. In addition, the audit
committee reviews the qualifications of our independent
auditors, is responsible for their appointment, compensation,
retention and oversight and reviews the scope, fees and results
of activities related to audit and non-audit services. We
believe that our audit committee members meet the requirements
for independence and financial literacy under the current
requirements of the Sarbanes-Oxley Act of 2002, the Nasdaq
Global Market and SEC rules and regulations. In addition, our
board of directors has determined that Mr. Costantino is an
audit committee financial expert. We have made these
determinations based on information received by our board of
directors, including questionnaires provided by the members of
our audit committee. We believe that our audit committee
complies with the applicable requirements of the Sarbanes-Oxley
Act of 2002, the Nasdaq Global Market and SEC rules and
regulations. We intend to comply with future requirements to the
extent they become applicable to us. We have adopted an audit
committee charter. The meeting schedule for the audit committee
has not yet been established, but we expect that the committee
will meet no less frequently than quarterly.
Our compensation committee consists of Messrs. Barone,
Costantino and Otremba, with Mr. Otremba serving as its chair.
The compensation committees principal responsibilities are
to administer our stock plans and to set the salary and
incentive compensation, including stock option grants, for our
Chief Executive Officer and senior management. We believe that
our compensation committee members meet the requirements for
independence under the current requirements of the
Sarbanes-Oxley Act of 2002, the Nasdaq Global Market and SEC
rules and regulations. We have made this determination based on
information received by our board of directors, including
questionnaires provided by the members of our compensation
committee. We believe that our compensation committee complies
with the applicable requirements of the Sarbanes-Oxley Act of
2002, the Nasdaq Global Market and SEC rules and regulations. We
intend to comply with future requirements to the extent they
become applicable to us. We have adopted a compensation
committee charter. The meeting schedule for the compensation
committee has not yet been established, but we expect that the
committee will meet at least once a year.
|
|
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Nominating and Corporate Governance Committee |
Our nominating and corporate governance committee consists of
Messrs. Barone, Costantino and Otremba, with Mr. Costantino
serving as its chair. The nominating and corporate governance
committee is responsible for reviewing and making
recommendations on the composition of our board and selection of
directors, periodically assessing the functioning of our board
of directors and its committees, and making recommendations to
our board of directors regarding corporate governance matters
and practices. We believe that our nominating and corporate
governance committee members meet the requirements for
independence under the current requirements of the
Sarbanes-Oxley Act of 2002, the Nasdaq Global Market and SEC
rules and regulations. We have made this determination based on
information received by our board of directors, including
questionnaires provided by the members of our nominating and
corporate governance committee. We believe that our nominating
and corporate governance committee complies with the applicable
83
requirements of the Sarbanes-Oxley Act of 2002, the Nasdaq
Global Market and SEC rules and regulations. We intend to comply
with future requirements to the extent they become applicable to
us. We have adopted a nominating and corporate governance
committee charter. The meeting schedule for the nominating and
corporate governance committee has not yet been established, but
we expect that the committee will meet at least once a year.
We strive to operate within a comprehensive plan of corporate
governance for the purpose of defining responsibilities, setting
high standards of professional and personal conduct and assuring
compliance with these responsibilities and standards. We have
implemented changes to our corporate governance structure and
procedures in response to the Sarbanes-Oxley Act of 2002 and the
adopted changes in the Nasdaq Global Markets listing
standards regarding corporate governance. We believe that our
current corporate governance structure and procedures comply
with existing corporate governance requirements. We will strive
to maintain our board of directors and committees in full
compliance with these corporate governance requirements on an
ongoing basis. We will also continue to regularly monitor
developments in the area of corporate governance.
Compensation Committee Interlocks and Insider
Participation
No member of our compensation committee is an officer, former
officer or employee of our company. No interlocking relationship
exists between any of our executive officers or compensation
committee members, on the one hand, and the executive officers
or compensation committee members of any other entity, on the
other hand, nor has any such interlocking relationship existed
in the past.
Director Compensation
In March 2006, our board of directors approved a compensation
program pursuant to which we will pay each of our non-employee
directors an annual retainer of up to $24,000, payable in
amounts of $5,000 on a quarterly basis, plus an additional
$1,000 for each quarterly board meeting attended. We also will
pay an additional $12,000 per year to each member of the
audit committee, payable on a quarterly basis. We reimburse each
non-employee director for
out-of-pocket expenses
incurred in connection with attending our board and committee
meetings. The cash compensation paid to our directors may be
adjusted from time to time as our board of directors may
determine.
We have in the past granted to our directors options to purchase
shares of common stock under our 2001 Stock Option Plan, or the
2001 Plan, or issued them warrants to purchase shares of our
common stock. In March 2006, our board of directors approved the
issuance of an option to purchase 23,529 shares of common
stock to each of our non-employee directors under the 2001 Plan.
These options vest at a rate of 1/48th per month over a period
of four years from the date of grant, subject to full
acceleration upon a change of control. Our board of directors or
the compensation committee of our board of directors may, at its
discretion, implement a policy regarding the issuance of stock
options or other equity-based awards to our non-employee
directors under our 2006 Equity Incentive Plan, or the 2006
Plan, after the completion of this offering. All options subject
to automatic grants to our non-employee directors under the 2006
Plan will be non-statutory stock options.
During fiscal 2005, upon initial election or appointment to the
board of directors, each non-employee director was issued a
warrant to purchase 17,647 shares of our common stock.
Mr. Barone received a warrant to
purchase 17,647 shares of our common stock upon his
election to the board of directors in April 2005. This warrant
has a ten-year term,
and has an exercise price equal to the fair market value of our
common stock, as determined by our board of directors on the
date of grant. This warrant vests in equal monthly installments
over a period of four years from the date of grant. In December
2005, Mr. Barone received an additional warrant to purchase
11,764 shares of common stock in consideration for his
services as a director. This warrant has a five-year term, and
has an exercise price equal to the fair market value of our
common stock, as determined by our board of directors on the
date of grant. This warrant also vests in equal monthly
installments over a period four years from the date of grant.
We are party to a directors agreement with
Mr. Reinhard, pursuant to which, among other things, we
issued him a warrant to purchase 152,941 shares of our common
stock. In January 2006, we issued
84
Mr. Reinhard an additional warrant to purchase 35,294
shares of our common stock, in consideration for services
performed during fiscal 2005. See Certain Relationships
and Related Party Transactions Directors
Agreement and Warrants Issued to Christopher Reinhard.
In November 2006, our board of directors granted NGN Capital LLC
an option to purchase up to 31,796 shares of common stock,
at an exercise price of $10.63 per share, in connection with
Mr. Costantinos service as a director on our board of
directors. The options vest in equal monthly installments over a
48-month period
commencing in June 2006.
Limitation of Liability and Indemnification of Officers and
Directors
Our amended and restated certificate of incorporation, which
will become effective upon the completion of this offering,
limits the liability of our directors to the maximum extent
permitted by Delaware law. Delaware law provides that a
corporation may eliminate the personal liability of its
directors for monetary damages for breach of their fiduciary
duties as directors, except liability for any of the following
acts:
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breach of their duty of loyalty to us or our stockholders; |
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acts or omissions not in good faith or that involve intentional
misconduct or a knowing violation of law; |
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unlawful payments of dividends or unlawful stock repurchases or
redemptions; and |
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any transaction from which the director derived an improper
personal benefit. |
Our amended and restated certificate of incorporation also
provides that we will indemnify our directors, officers,
employees and other agents to the fullest extent permitted by
the Delaware General Corporation Law.
Our amended and restated bylaws, which will become effective
upon the completion of this offering, provide that (i) we
are required to indemnify our directors and officers to the
fullest extent permitted by the Delaware General Corporation
Law, subject to certain very limited exceptions, (ii) we
are required to advance expenses, as incurred, to our directors
and executive officers in connection with a legal proceeding to
the fullest extent permitted by the Delaware General Corporation
Law, subject to certain very limited exceptions and
(iii) the rights conferred in the amended and restated
bylaws are not exclusive.
We have entered into indemnification agreements with each of our
directors and executive officers to give these individuals
additional contractual assurances regarding the scope of the
indemnification set forth in our amended and restated
certificate of incorporation and bylaws and to provide
additional procedural protections. We intend to enter into
indemnification agreements with any new directors and executive
officers in the future. We have obtained directors and
officers insurance providing coverage for all of our
directors and officers for certain liabilities. We believe that
these provisions and this insurance are necessary to attract and
retain qualified directors and officers.
In August 2005, Elizabeth Sandor, an individual residing in
San Diego, California, filed a complaint against us,
Drs. Gottfried Lemperle, Stefan Lemperle and Steven Cohen,
in the Superior Court of the State of California for the County
of San Diego. The complaint, as amended, set forth various
causes of action against us, including product liability, fraud,
negligence and negligent misrepresentation, and alleged that
Dr. Gottfried Lemperle, our
co-founder, former
Chief Scientific Officer and a former member of our board of
directors, administered injections of Artecoll and/or ArteFill
to Ms. Sandor in violation of medical licensure laws, that
the product was defective and unsafe because it had not received
FDA approval at the time it was administered to Ms. Sandor,
and that Ms. Sandor experienced adverse reactions as a
result of the injections. The complaint also alleged that
Dr. Gottfried Lemperle and his son, Dr. Stefan Lemperle,
our other co-founder, former Chief Executive Officer and a
former director, falsely represented to her that the product had
received an approvability letter from the FDA, and was safe and
without the potential for adverse reactions. See
Business Legal Proceedings. We notified
our directors and officers liability insurance
carrier of Ms. Sandors claims and requested both a
defense and indemnification for all claims advanced by
Ms. Sandor. Our insurance carrier has declined coverage. We
disclaim any liability for the actions of any person acting in
his individual capacity and not as our agent.
85
As reported in Business Legal
Proceedings, the FDAs Office of Criminal
Investigations is conducting an investigation which we believe
may concern improper uses of our product prior to FDA approval
by us, Dr. Gottfried Lemperle, a former officer and
director, and Dr. Stefan M. Lemperle, a former officer and
director. Although we have confirmed than this investigation is
ongoing, we have received no confirmation of the subject matter
of this investigation. We have not been, and to our knowledge,
neither Drs. Gottfried Lemperle nor Stefan M. Lemperle nor
any of our other former or current officers and directors have
been contacted by the FDA regarding this investigation. If any
proceeding or action is instituted by the FDA or another
government agency against any of our former or current officers
and directors regarding improper uses of our product prior to
FDA approval, the officers and directors named in these
proceedings or actions may request indemnification by the
Company. Similarly, if any of our officers and directors are
named as parties in the pending legal actions by
Messrs. Schreiber and von Brendel described in
Business Legal Proceedings, these
officers may request indemnification by the Company. Other than
the matters described above, we are not aware of any pending or
threatened litigation or proceeding that might result in a claim
for indemnification against us.
Executive Compensation
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Summary compensation table |
The following table summarizes the compensation paid to, awarded
to or earned during the fiscal year ended December 31, 2005
by our former Chief Executive Officer and our four other most
highly compensated executive officers whose annual compensation
during fiscal 2005 exceeded $100,000. We refer to our former
Chief Executive Officer and the executive officers listed in the
table below as our named executive officers in this
prospectus.
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Long term | |
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compensation | |
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Annual Compensation ($) |
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Securities | |
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underlying | |
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Other annual |
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options | |
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All other | |
Name and principal position(s) |
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Salary (1) | |
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Bonus (2) | |
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compensation(3) |
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(# of shares) | |
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compensation ($) | |
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Christopher J. Reinhard(4)
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$ |
112,608 |
(5) |
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$ |
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$ |
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35,294 |
(6) |
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Executive Chairman of the Board of Directors |
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Peter C. Wulff
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148,519 |
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70,588 |
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Chief Financial Officer |
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Stefan M. Lemperle, M.D.(7)
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253,172 |
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$ |
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Former Chief Executive Officer and former President |
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Gottfried Lemperle, M.D., Ph.D.(8)
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187,882 |
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70,000 |
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Former Vice President of Research and Development and former
Chief Scientific Officer |
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William von Brendel(9)
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162,346 |
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29,411 |
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Former Vice President of Worldwide Sales and International
Markets |
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(1) |
Includes amounts deferred at the election of each named
executive officer under our 401(k) plan. |
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(2) |
In March 2006, our board of directors approved a bonus pool of
$950,000 to be allocated among our employees in consideration
for their performance during fiscal 2005. We anticipate that the
compensation committee will approve individual bonus allocations
to our executive officers from this pool after completion of
this offering. |
86
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(3) |
In accordance with Item 402(b)(2)(iii)(C)(1) of
Regulation S-K
promulgated under the Securities Act of 1933, the other annual
compensation in this table does not include various perquisites
and other personal benefits received by a named executive
officer that does not exceed the lesser of $50,000 or 10% of
such officers salary and bonus disclosed in this table. |
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(4) |
Christopher J. Reinhard is employed with us on a part-time
basis as our Executive Chairman of the Board of Directors. As a
result, he is deemed to be an executive officer of our company. |
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(5) |
Represents $21,168 paid in cash and $91,440 paid in the form of
shares of our common stock at the fair market value for our
common stock, as determined by our board of directors, as of
each payment date in accordance with our standard payroll
schedule. |
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(6) |
Represents 35,294 shares of common stock issuable upon the
exercise of a warrant granted to Mr. Reinhard in January
2006 in consideration for services in his capacity as our
Executive Chairman of the Board of Directors during fiscal 2005.
See Related Party Transactions Directors
Agreement and Warrants Issued to Christopher Reinhard. |
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(7) |
Dr. Stefan M. Lemperle served as our Chief Executive Officer
from August 1999 to October 2006. |
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(8) |
Dr. Gottfried Lemperle resigned from his positions as Vice
President of Research and Development and Chief Scientific
Officer in March 2006. Pursuant to a separation agreement
entered into with Dr. Lemperle in connection with his
resignation, we paid Dr. Lemperle a cash bonus of $70,000
in March 2006, in consideration for his performance during
fiscal 2005. |
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(9) |
Mr. William von Brendel served as our Vice President of
Worldwide Sales and International Markets from July 2004 to
October 2006. |
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Option grants in fiscal year 2005 |
In April 2001, our board of directors adopted, and our
stockholders approved, our 2001 Stock Option Plan, or the 2001
Plan. All options granted prior to the closing of this offering
are governed by the terms of the 2001 Plan, except for 58,117
options that were granted from November 1999 to April 2001 under
our 2000 Stock Option Plan or pursuant to individual option
agreements (net of cancellations).
During the fiscal year ended December 31, 2005, we granted
options to purchase a total of 610,588 shares of our common
stock at an average exercise price of $5.31 per share to
our employees, including certain of our named executive
officers. Generally, options granted under the 2001 Plan vest in
48 successive equal monthly installments after the date of grant
or the vesting start date determined by our board of directors.
The options granted to Mr. von Brendel and Mr. Wulff
during the fiscal year ended December 31, 2005 vest in 48
successive equal monthly installments after the date of grant.
Under the terms of our 2001 Plan, any options to purchase shares
of our common stock that expire or are otherwise terminated are
returned to the option pool and become available for future
grant under the plan. Options expire ten years from the date of
grant.
The exercise price per share of each option granted to our named
executive officers was equal to the fair market value of our
common stock, as determined by our board of directors on the
date of the grant. The exercise price is payable in cash, by
promissory note or in shares of our common stock previously
owned by the optionee. In determining the fair market value of
the stock granted on the grant date, our board of directors
considered many factors, including:
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the illiquid nature of our securities as a nonpublic company; |
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the prices of preferred stock issued by us to outside investors
in arms-length transactions; |
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the rights, preferences and privileges of our preferred stock
over our common stock; and |
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the likelihood that our common stock would become liquid through
an initial public offering, a sale of our company or another
event. |
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The following table provides information concerning grants of
options to purchase shares of our common stock under the 2001
Plan to our named executive officers during the fiscal year
ended December 31, 2005. We did not grant any stock
appreciation rights covering our common stock to our named
executive officers during the fiscal year ended
December 31, 2005.
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Potential realizable | |
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value at assumed | |
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annual rates of | |
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Number of | |
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stock price | |
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securities | |
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Percentage of total | |
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appreciation | |
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underlying | |
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options granted | |
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Exercise | |
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for option term(2) | |
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options | |
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to employees | |
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price | |
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Expiration | |
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Name |
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granted | |
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in fiscal year(1) | |
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per share | |
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date | |
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5% | |
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10% | |
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Christopher J. Reinhard
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$ |
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$ |
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$ |
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Peter C. Wulff
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47,058 |
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7.7 |
% |
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5.31 |
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4/22/2015 |
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49,172 |
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73,082 |
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23,529 |
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3.9 |
% |
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5.31 |
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12/15/2015 |
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25,186 |
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38,281 |
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Stefan M. Lemperle, M.D.
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Gottfried Lemperle, M.D., Ph.D.
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William von Brendel
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29,411 |
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4.8 |
% |
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5.31 |
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12/15/2015 |
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31,482 |
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47,851 |
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(1) |
Based on 610,588 options granted during the fiscal year ended
December 31, 2005 under the 2001 Plan, including grants to
our named executive officers. |
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(2) |
Potential realizable values are computed by (a) multiplying
the number of shares of common stock subject to a given option
by the initial public offering price of $6.00 per share,
(b) assuming that the aggregate stock value derived from
that calculation compounds at the annual 5% or 10% rate shown in
the table for the entire term of the option and
(c) subtracting from that result the aggregate option
exercise price. The 5% and 10% assumed annual rates of stock
price appreciation are mandated by the rules of the SEC and do
not represent our estimate or projection of future common stock
prices. |
Aggregated option
exercises in last fiscal year and fiscal year-end option
values
There were no option exercises by our named executive officers
during the fiscal year ended December 31, 2005. The
following table summarizes the value of options held by them as
of December 31, 2005. There was no public trading market
for our common stock as of December 31, 2005. Accordingly,
the value of unexercised
in-the-money options
listed below has been calculated on the basis of the initial
public offering price of $6.00 per share, less the
applicable exercise price per share multiplied by the number of
shares underlying the options.
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Number of securities | |
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Value of unexercised | |
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Shares | |
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underlying unexercised options | |
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in-the-money options | |
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acquired | |
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at December 31, 2005 | |
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at December 31, 2005 | |
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upon | |
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Value | |
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Name |
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exercise | |
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realized | |
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Exercisable | |
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Unexercisable | |
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Exercisable | |
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Unexercisable | |
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Christopher J. Reinhard
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130,882 |
(1) |
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22,058 |
(1) |
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$ |
90,309 |
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$ |
15,220 |
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Peter C. Wulff
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10,784 |
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59,804 |
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7,441 |
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41,265 |
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Stefan M. Lemperle, M.D.
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70,588 |
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318,528 |
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Gottfried Lemperle, M.D., Ph.D.
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38,235 |
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55,882 |
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141,728 |
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131,801 |
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William von Brendel
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11,909 |
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49,266 |
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20,841 |
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55,040 |
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(1) |
Represents shares issuable upon the exercise of warrants to
purchase common stock at an exercise price of $5.31 per share
granted to Mr. Reinhard. See Management
Director Compensation. |
88
Employment, Severance and Change of Control Agreements
We have entered into employment agreements with Russell
Anderson, our Vice President Product Development and
Engineering and Lawrence Braga, our Vice President
Manufacturing.
Pursuant to the employment agreements, each of
Messrs. Anderson and Braga is required to devote his full
business time to his services to us. The annual base salaries of
Messrs. Anderson and Braga are set forth in their
respective employment agreements. The employment agreements do
not provide for automatic annual increases in salary, but our
board of directors may, in its discretion, review the annual
base salaries and approve increases to the base salaries.
Pursuant to their employment agreements, Messrs. Anderson
and Braga received options to purchase common stock at the
then-current fair market value under our 2001 Stock Option Plan.
We may terminate our relationship with Messrs. Anderson and
Braga at any time, with or without cause. Their employment
agreements provide each executive with certain severance
benefits in the event his employment is terminated other than
for good cause, as defined in the agreements. Specifically, in
the event of such a termination, the executive will receive
three months of salary continuation payments at his then-current
base salary and up to three months of medical, dental, long-term
disability and retirement benefits as then available to
full-time employees (except in the event the executive
voluntarily resigns, in which case he will not be entitled to
the continuation of medical, dental, long-term disability and
retirement benefits). Pursuant to their employment agreements,
each of Messrs. Anderson and Braga are also entitled to
receive his respective severance benefits described above in the
event that we effect a change of control, and the executive
resigns as a result of the change of control and the failure of
the acquiring or surviving company to agree to his existing
employment terms with us.
We have also entered into an employment offer letter agreement
with Diane Goostree, our President and Chief Executive Officer
and a director on our board of directors. This agreement, as
amended, provides for an initial annual base salary of $300,000.
In addition, Ms. Goostree received a bonus of $75,000 as an
incentive for accepting our offer of employment and a bonus of
$50,000 as compensation for a bonus that Ms. Goostree
became ineligible to receive from her previous employer as a
result of her acceptance of our offer. If Ms. Goostree
voluntarily resigns other than for good reason, as defined in
the agreement, within the first 24 months of her
employment, a prorated portion of the $75,000 incentive bonus
will be due to us. Ms. Goostree is also eligible to receive
an annual performance-based bonus of up to 50% of her annual
base salary, which will be based on both company and individual
objectives and is subject to board approval. Pursuant to the
offer letter agreement, Ms. Goostree received an option to
purchase 117,647 shares of common stock under our 2001
Stock Option Plan at the then-current fair market value.
Ms. Goostree is an at-will employee. Her employment offer
letter provides her with certain severance benefits in the event
her employment is terminated other than for good cause, as
defined in the agreement, if she resigns for good reason or if
her termination results from a change of control, as defined in
the agreement. Specifically, in the event of such a termination,
Ms. Goostree will receive a lump-sum payment equal to nine
months of her then-current annual base salary and nine months of
continued health insurance coverage under COBRA, as well as any
unpaid salary, earned bonus amounts, unused paid time off and
reimbursable business expenses through the date of termination.
In the event of a termination in connection with a change of
control, any unvested stock options held by Ms. Goostree
that would otherwise lapse upon the change of control will be
subject to accelerated vesting in the amount that would have
vested over the nine months after her termination, subject to
board approval. Ms. Goostree has agreed to resign as a director
on our board of directors effective immediately upon the date
she resigns or is removed from her office as Chief Executive
Officer.
Following our internal investigation in March 2006, we entered
into a separation agreement with Dr. Gottfried Lemperle in
connection with his retirement and resignation as our Vice
President of Research and Development, Chief Scientific Officer
and a director. Under the terms of the agreement, we agreed to
pay Dr. Gottfried Lemperle a cash bonus of $70,000 for his
performance during fiscal year 2005 and to retain
Dr. Gottfried Lemperle as a consultant to us for an initial
term of up to 24 months beginning March 15, 2006,
subject to an extension for an additional 12 months under
certain circumstances. In connection with the separation
agreement, Dr. Gottfried Lemperle also entered into a
voting agreement with us, pursuant to which he has agreed to
vote all shares of voting capital stock owned by him as directed
by a majority of our board of directors on all matters presented
for a vote of our stockholders. In May 2006, we terminated the
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consulting arrangement as permitted under the terms of the
separation agreement, and we paid Dr. Gottfried Lemperle a
lump sum payment of $366,667, the amount to which he would have
been entitled had he completed the initial term of the
separation agreement.
On November 17, 2006, we entered into a separation
agreement and mutual general release with Dr. Stefan M.
Lemperle in connection with his resignation as a director and as
an employee. Pursuant to the agreement, we have paid
Dr. Stefan Lemperle a severance payment of $250,000, plus
an additional $81,250 in lieu of any bonus payments related to
fiscal years 2005 and 2006. We also agreed to make severance
payments to Dr. Stefan M. Lemperle in an aggregate amount
of $300,000, payable in 12 monthly installments of $25,000
per month, commencing in December 2006, and to provide COBRA
coverage to Dr. Stefan M. Lemperle for a period of
12 months from the date of his resignation. Dr. Stefan
M. Lemperle is eligible to receive an additional severance
payment of $400,000, contingent upon our completion of this
offering or another qualifying transaction, as defined in the
agreement, before March 31, 2007. In connection with the
agreement, we also amended the terms of the outstanding stock
options held by Dr. Stefan M. Lemperle to provide for the
full acceleration of all unvested shares under his stock
options, and we have agreed to issue to Dr. Stefan M.
Lemperle a warrant to purchase up to 117,647 shares of
common stock, subject to certain conditions and in an amount
determined in accordance with the terms of the agreement. In
consideration for these payments and benefits, Dr. Stefan
M. Lemperle has provided a general release of claims against us
and has agreed to cooperate with us in various matters,
including assisting us in responding to questions raised by the
FDA or other regulatory bodies, facilitating the completion of
our initial public offering and assisting us with the resolution
of outstanding claims against us by certain former employees.
In July 2004 and July 2005, respectively, we also entered into
employment agreements with William von Brendel, our former Vice
President Worldwide Sales and International Markets,
and Harald T. Schreiber, our former Chief Creative Officer, on
terms substantially similar to those under our employment
agreements with Messrs. Anderson and Braga. Mr. von
Brendel was additionally entitled to whole life insurance under
his employment agreement, and Mr. Schreiber also received,
in addition to his option grant, (i) a warrant to
purchase 10,000 shares of common stock at an exercise
price of $4.25 per share in consideration for consulting
services provided to us prior to his employment, (ii) a
warrant to purchase 5,882 shares of common stock at an
exercise price of $5.31 in consideration for the assignment of
certain intellectual property rights to us in connection with
his employment and (iii) a warrant to
purchase 11,764 shares of common stock at an exercise
price of $5.31 in consideration for certain promotional services
performed by Mr. Schreiber for us. In connection with a
reduction in costs and the reorganization of our sales and
marketing organization, we terminated the employment of
Messrs. von Brendel and Schreiber on October 27, 2006.
Mr. Schreiber filed a demand for arbitration against us on
November 2, 2006. Mr. von Brendel filed a demand for
arbitration against us on November 16, 2006. We are
currently in settlement discussions with both Messrs. Schreiber
and von Brendel. See Business Legal
Proceedings.
Equity Compensation Plan Information
2006 Equity Incentive
Plan
Our 2006 Equity Incentive Plan, which we refer to as the 2006
Plan, is intended to serve as the successor equity incentive
program to our 2001 Stock Option Plan, or the 2001 Plan. We
expect that our 2006 Plan will be adopted by our board of
directors and stockholders prior to the completion of this
offering, and that our 2006 Plan will become effective upon
completion of this offering. Upon completion of this offering,
all shares of stock remaining available for issuance and not
subject to outstanding options under the 2001 Plan will become
part of the available pool of shares under our 2006 Plan, and no
further option grants will be made under the 2001 Plan. The
options granted under the 2001 Plan will continue to be governed
by their existing terms, unless our compensation committee
elects to extend one or more features of our 2006 Plan to those
options. The 2006 Plan will terminate on the earlier of
(i) ten years after its adoption by our board of directors
or by our stockholders, whichever adoption is earlier, or
(ii) when the board of directors terminates the 2006 Plan.
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Stock options, stock appreciation rights, or SARs, stock awards
and cash awards may be granted under the 2006 Plan. Each is
referred to as an award in the 2006 Plan. Options granted under
the 2006 Plan may be either incentive stock options,
as defined under Section 422 of the Internal Revenue Code
of 1986, as amended, or nonstatutory stock options.
Share Reserve. We have reserved an aggregate
5,882,352 shares of our common stock, including the shares
from our 2001 Plan and our 2000 Plan described below, for
issuance under the 2006 Plan. Awards generally shall not reduce
the share reserve until the earlier of vesting or the delivery
of the shares pursuant to an award. Shares reserved under the
plan also include (i) shares of common stock available for
issuance as of the effective date of this offering under the
2001 Plan and 2000 Plan plus (ii) shares of common stock
issued under the 2001 Plan, 2000 Plan or the 2006 Plan that are
forfeited or repurchased by us at or below the original purchase
price or that are issuable upon exercise of awards granted
pursuant to the 2001 Plan, 2000 Plan or the 2006 Plan that
expire or become unexercisable for any reason without having
been exercised after the effective date of this offering, plus
(iii) shares of common stock that are restored by our board
of directors or its compensation committee pursuant to
provisions in the 2006 Plan that permit options to be settled in
shares on a net appreciation basis at our election.
Automatic Annual Increase of Share Reserve. The 2006 Plan
provides that the share reserve will be cumulatively increased
on January 1 of each year, beginning January 1, 2007 and
for nine years thereafter, by a number of shares that is equal
to the lesser of (a) 5% of the number of our companys
shares issued and outstanding prior to the preceding
December 31, (b) 2,352,941 shares and (c) a
number of shares set by our board of directors.
Administration. The 2006 Plan will be administered by the
Compensation Committee of our board of directors or a delegated
officer in certain instances. The Compensation Committee or
officer is referred to in the 2006 Plan as the administrator.
Eligibility. Awards under the 2006 Plan may be granted to
our employees, directors and consultants. Incentive stock
options may be granted only to our employees. The administrator,
in its discretion, approves awards granted under the 2006 Plan.
Termination of Awards. Generally, if an awardees
service to us terminates other than by reason of death,
disability, retirement or for cause, vested options and SARs
will remain exercisable for a period of three months following
the termination of the awardees service. Unless otherwise
provided for by the administrator in the award agreement, if an
awardee dies or becomes totally and permanently disabled while
an employee or consultant or director, the awardees vested
options and SARs will be exercisable for one year following the
awardees death or disability, or if earlier, the
expiration of the term of such award.
Nontransferability of Awards. Unless otherwise determined
by the administrator, awards granted under the 2006 Plan are not
transferable other than by will, a domestic relations order, or
the laws of descent and distribution and may be exercised during
the awardees lifetime only by the awardee.
Exercise Price of Options. The administrator determines
the exercise price of options at the time the options are
granted. The exercise price of an incentive stock option may not
be less than 100% of the fair market value of the our common
stock on the date of grant. The exercise price of a nonstatutory
stock option may not be less than par value of our common stock.
The fair market value of our common stock will generally be the
closing sales price as quoted on the Nasdaq Global Market.
Exercise of Option; Form of Consideration. The
administrator determines the vesting schedule (if any)
applicable to options. The administrator may grant options that
are exercisable for unvested shares of common stock. To the
extent that an optionee exercises an unvested option, we
generally have the right to repurchase any or all of such
unvested shares for either the exercise price paid by the
optionee for such shares or the lower of the (i) exercise
price paid by the optionee for such shares or (ii) current
fair market value of such shares, as determined in accordance
with the 2006 Plan, upon termination of optionees
employment or other relationship with us. This repurchase right
lapses at the same rate as the vesting schedule applicable to
the shares underlying the option. The means of payment for
shares issued on exercise of an option are specified in each
award agreement. The 2006 Plan permits payment to be made by any
lawful
91
means including cash, check, wire transfer, other shares of our
common stock (with some restrictions), broker-assisted same day
sales or cancellation of any debt owed by us or any of our
affiliates to the optionholder or in certain instances a
delivery of cash or stock for any net appreciation.
Term of Options. The term of an option may be no more
than ten years from the date of grant. No option may be
exercised after the expiration of its term. Any incentive stock
option granted to a ten percent stockholder may not have a term
of more than five years.
Stock Appreciation Rights. The administrator may grant
SARs alone, in addition to, or in tandem with, any other awards
under this plan. An SAR entitles the participant to receive the
amount by which the fair market value of a specified number of
shares on the exercise date exceeds an exercise price
established by the administrator. The excess amount will be
payable in ordinary shares, in cash or in a combination thereof,
as determined by the administrator. The terms and conditions of
an SAR will be contained in an award agreement. The grant of an
SAR may be made contingent upon the achievement of objective
performance conditions.
Stock Awards. The administrator may grant stock awards
such as bonus stock, restricted stock or restricted stock units.
Generally such awards will contain vesting features such that
awards will either not be delivered, or may be repurchased by us
at cost, if the vesting requirements are not met. The
administrator will determine the vesting and share delivery
terms. In the case of restricted stock units the administrator
may in its discretion offer the awardee the right to defer
delivery. Stock awards may be settled in cash or stock as
determined by the administrator.
Amended and Restated
2001 Stock Option Plan
In April 2001, we adopted our 2001 Stock Option Plan, or the
2001 Plan, which was approved by our stockholders in April 2001.
Our board of directors most recently amended and restated the
plan in August 2005 and our stockholders approved the amended
and restated plan in August 2005. The 2001 Plan provides for the
grant of incentive stock options, as defined under
Section 422 of the Internal Revenue Code, to employees and
for the grant of non-statutory stock options to employees,
consultants, and non-employee directors. A total of
2,352,941 shares of our common stock have been authorized
and reserved for issuance under the 2001 Plan. As of
September 30, 2006, options to purchase a total of
1,813,916 shares of common stock, with a weighted average
exercise price of $5.98 per share, were outstanding under
the 2001 Plan.
Upon the effectiveness of our initial public offering, we will
no longer issue any additional options under the 2001 Plan.
Although no future options will be granted under this plan, all
options previously granted under the 2001 Plan will continue to
be outstanding and will be administered under the terms and
conditions of the 2001 Plan.
Our board of directors, or a committee thereof, will continue to
administer the 2001 Plan. The exercise price of all incentive
stock options granted under the 2001 Plan must be at least equal
to the fair market value of the common stock on the date of
grant. The exercise price of all non-statutory stock options
granted under the 2001 Plan shall be determined by our board of
directors or a committee thereof, but in no event may be less
than 85% of the fair market value on the date of grant. With
respect to any optionee who owns stock possessing more than 10%
of the voting power of all our classes of stock, the exercise
price of any incentive stock option or non-statutory stock
option granted must equal at least 110% of the fair market value
on the grant date. The 2001 Plan provides for an option term of
up to 10 years, but not to exceed five years for incentive
stock options granted to 10% stockholders. Generally, options
granted under the 2001 Plan vest in 48 successive equal monthly
installments after the date of grant.
If an optionees service terminates for any reason other
than death, disability or cause, the optionee may exercise his
or her vested options prior to the earlier of their expiration
date or three months following the date of termination. In the
event the optionees service terminates as a result of the
optionees death, the options vested as of the date of
death may be exercised prior to the earlier of their expiration
date or 6 months from the date of the optionees
death. In the event the optionees service terminates as a
result of the optionees disability, the options vested as
of the date of disability may be exercised prior to the earlier
of their
92
expiration date or one year from the date of the optionees
disability. If an optionees service is terminated by the
company for cause, all outstanding options shall terminate upon
the earlier of their expiration date or the date of the
occurrence giving rise to termination for cause.
All stock options granted under the 2001 Plan are
non-transferable other than by will or the laws of descent and
distribution following the optionees death.
In the event of a corporate transaction where the acquiror
assumes or replaces options granted under the 2001 Plan, options
issued under the 2001 Plan will not be subject to accelerated
vesting unless provided otherwise by agreement with the optionee
or unless our board of directors or a committee thereof
accelerates such vesting. In the event of a corporate
transaction where the acquiror does not assume or replace
options granted under the 2001 Plan, such outstanding options
will become fully vested and exercisable 30 days prior to
the consummation of the corporate transaction. In the event of a
corporate transaction where the acquiror does not assume options
granted under the 2001 Plan, such outstanding options will
terminate upon the consummation of the corporate transaction.
2000 Stock Option
Plan
In May 2000, we adopted our 2000 Stock Option Plan, or the 2000
Plan, which was approved by our stockholders in May 2000. The
2000 Plan provides for the grant of incentive stock options, as
defined under Section 422 of the Internal Revenue Code, to
employees and for the grant of non-statutory stock options to
employees, consultants, and non-employee directors. A total of
235,294 shares of our common stock have been authorized and
reserved for issuance under the 2000 Plan. As of
September 30, 2006, options to purchase a total of
25,880 shares of common stock, with a weighted average
exercise price of $2.34 per share, were outstanding under
the 2000 Plan.
The 2000 Plan was terminated and superceded by adoption and
approval of the 2001 Plan, effective April 2001. No additional
options have been issued under the 2000 Plan since April 2001.
Upon the effectiveness of our initial public offering, all
options previously granted under the 2000 Plan will continue to
be outstanding and will be administered under the terms and
conditions of the 2000 Plan.
Our board of directors, or a committee thereof, will continue to
administer the 2000 Plan. The exercise price of all incentive
stock options granted under the 2000 Plan must be at least equal
to the fair market value of the common stock on the date of
grant. The exercise price of all non-statutory stock options
granted under the 2000 Plan shall be determined by our board of
directors or a committee thereof, but in no event may be less
than 85% of the fair market value on the date of grant. With
respect to any optionee who owns stock possessing more than 10%
of the voting power of all our classes of stock, the exercise
price of any incentive stock option or non-statutory stock
option granted must equal at least 110% of the fair market value
on the grant date. The 2000 Plan provides for an option term of
up to 10 years, but not to exceed five years for incentive
stock options granted to 10% stockholders. Generally, options
granted under the 2000 Plan vest in 48 successive equal monthly
installments after the date of grant.
If an optionees service terminates for any reason other
than death, disability or cause, the optionee may exercise his
or her vested options prior to the earlier of their expiration
date or three months following the date of termination. In the
event the optionees service terminates as a result of the
optionees death, the options vested as of the date of
death may be exercised prior to the earlier of their expiration
date or 6 months from the date of the optionees
death. In the event the optionees service terminates as a
result of the optionees disability, the options vested as
of the date of disability may be exercised prior to the earlier
of their expiration date or one year from the date of the
optionees disability. If an optionees service is
terminated by the company for cause, all outstanding options
shall terminate upon the earlier of their expiration date or the
date of the occurrence giving rise to termination for cause.
All stock options granted under the 2000 Plan are
non-transferable other than by will or the laws of descent and
distribution following the optionees death.
In the event of a corporate transaction where the acquiror
assumes or replaces options granted under the 2000 Plan, options
issued under the 2000 Plan will not be subject to accelerated
vesting unless provided
93
otherwise by agreement with the optionee or unless our board of
directors or a committee thereof accelerates such vesting. In
the event of a corporate transaction where the acquiror does not
assume or replace options granted under the 2000 Plan, such
outstanding options will become fully vested and exercisable
30 days prior to the consummation of the corporate
transaction. In the event of a corporate transaction where the
acquiror does not assume options granted under the 2000 Plan,
such outstanding options will terminate upon the consummation of
the corporate transaction.
Individual Option
Grants
Prior to the establishment of the 2000 Plan, from November 1999
to May 2000, we granted options to purchase shares of common
stock pursuant to individual option agreements. These options
either were fully vested upon grant, or vested in equal monthly
installments over a period of three or four years. As of
September 30, 2006, options to purchase a total of
29,880 shares of common stock, with a weighted average
exercise price of $0.51 per share, were outstanding under
these individual option agreements.
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RELATED PARTY TRANSACTIONS
The following is a description of each transaction or series of
transactions during the past three fiscal years, to which we
have been a party, and in which the amount involved exceeds
$60,000 and in which any of our directors, named executive
officers or other executive officers, any holder of more than 5%
of our common stock or any member of the immediate family of any
of these persons had or will have a direct or indirect material
interest, other than the compensation arrangements (including
with respect to equity compensation) described in
Management. We believe that we have executed all of
the transactions described below on terms no less favorable to
us than we could have obtained from unaffiliated third parties.
All future transactions between us and our officers, directors
and principal stockholders and their affiliates will be approved
by the Audit Committee of our board of directors or a majority
of our board of directors, including a majority of the
independent and disinterested members of our board of directors,
and will be on terms no less favorable to us than those that we
could obtain from unaffiliated third parties. All of the share
and per share numbers in this Section assume the completion of a
one-for-4.25 reverse stock split of our outstanding common stock
and the conversion of all outstanding shares of preferred stock
into common stock, which events will occur in connection with
the closing of this offering.
Indications of Interest in Purchasing Shares in this Offering
by our Existing Stockholders
Certain of our existing stockholders have indicated an interest
in purchasing up to approximately 800,000 shares of our
common stock in this offering at the initial public offering
price. However, because indications of interest are not binding
agreements or commitments to purchase, our underwriters may
determine not to sell shares in this offering to our existing
stockholders, or our stockholders may decide not to purchase
shares in this offering.
Securities Issuances
From May 2002 to March 2003, we issued and sold convertible
promissory notes in the aggregate principal amount of $2,615,000
and warrants to purchase an aggregate of 615,294 shares of
Series C-1 preferred stock at an exercise price of
$4.25 per share to investors in a bridge loan financing
transaction. The securities issued in the bridge loan financing
included a convertible promissory note in the principal amount
of $743,005 and a warrant to purchase 174,824 shares
of our Series C-1 preferred stock issued to Creative
Microspheres, Inc., a private company beneficially owned by our
former Chief Executive Officer and a former director,
Dr. Stefan Lemperle. All outstanding principal and interest
under the promissory note issued to Creative Microspheres,
representing an aggregate amount of $809,614, were converted
into 109,497 shares of our Series C-1 preferred stock
in July 2003.
In June 2004, we issued and sold convertible promissory notes in
the aggregate principal amount of $6,736,427 and warrants to
purchase an aggregate of 634,016 shares of common stock at an
exercise price of $5.31 per share to investors in a bridge loan
financing transaction. Christopher J. Reinhard, our Executive
Chairman of the Board of Directors, acquired a promissory note
in the principal amount of $100,000 and a warrant to purchase
9,411 shares of common stock. All outstanding principal and
interest under the promissory note, representing an aggregate
amount of $106,992, were converted into 20,139 shares of
Series D preferred stock in May 2005.
From December 2005 to March 2006, we issued shares of
Series E preferred stock and warrants to purchase shares of
Series E preferred stock at an exercise price of
$10.62 per share to investors in a private placement
transaction completed in a series of closings, for aggregate
gross proceeds of approximately $50.7 million. The
securities purchased by investors in this private placement
transactions included:
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9,411 shares of Series E preferred stock and warrants
to purchase 1,882 shares of Series E preferred
stock, issued for an aggregate purchase price of $100,000 to
Lon E. Otremba, a member of our board of directors; and |
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an aggregate of 470,588 shares of Series E preferred
stock and warrants to purchase 141,176 shares of
Series E preferred stock, issued for an aggregate purchase
price of $5.0 million to NGN Biomed |
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Opportunity I, L.P. and NGN Biomed Opportunity I
GmbH & Co. Beteiligungs KG, affiliated funds of NGN
Capital LLC. John R. Costantino, a member of our board of
directors, is Managing General Partner of NGN Capital LLC. |
Amendments to Outstanding Warrants
In June 2006, certain holders of warrants to purchase common
stock issued by us to various individuals and entities in
consideration for services provided to us, and certain holders
of warrants to purchase common stock and warrants to purchase
preferred stock issued by us to various individuals and entities
in connection with their investments in our securities, elected
to amend their warrants. Before their amendment, these warrants
had terms ranging from five to 10 years from their issuance
date, but would terminate upon the completion of this offering
if not exercised before the completion of this offering. As
amended, the warrants will not terminate upon the completion of
this offering but instead, will continue in effect under their
existing terms until (i) March 15, 2007, in the case of
warrants issued in consideration for services provided, or (ii)
the natural expiration date under the terms of the warrants, in
the case of warrants issued in connection with investments in
our prior financings. The amended warrants include the following
warrants held by related parties:
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warrants to purchase 7,058 shares of common stock at
an exercise price of $5.31 per share held by Christopher J.
Reinhard, our Executive Chairman of the Board of Directors; |
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warrants to purchase 4,705 shares of common stock at
an exercise price of $5.31 per share held by
Dr. Stefan M. Lemperle, our former Chief Executive Officer
and a former director and employee; |
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warrants to purchase 174,824 shares of Series C-1
preferred stock at an exercise price of $4.25 per share
held by Creative Microspheres, Inc., a private company
beneficially owned by Dr. Stefan M. Lemperle; |
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warrants to purchase 17,647 shares of common stock at
an exercise price of $5.31 per share held by Daren J.
Barone, a member of our board of directors; |
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warrants to purchase 18,823 shares of common stock at
an exercise price of $5.31 per share held by DJB Holdings,
LLC, of which Mr. Barone is the managing member; |
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warrants to purchase 4,352 shares of common stock at
an exercise price of $8.50 per share held by WB Partners,
LP, of which Mr. Barone is a general partner; and |
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warrants to purchase 2,470 shares of common stock at
an exercise price of $5.31 per share held by Lisa Bea Alton
Anderson, the wife of Russell J. Anderson, our Vice President,
Product Development and Engineering. |
Indemnification Agreements
We intend to enter into indemnification agreements with our
directors and executive officers for the indemnification of and
advancement of expenses to these persons to the fullest extent
permitted by law. We also intend to enter into these agreements
with our future directors and executive officers.
Directors Agreement and Warrants Issued to Christopher
Reinhard
In June 2004, we entered into a directors agreement with
Christopher Reinhard, our Executive Chairman of the Board of
Directors. Pursuant to this agreement, we issued a warrant to
purchase 117,647 shares of common stock to
Mr. Reinhard in consideration for his services as our
Executive Chairman. The warrant is exercisable for up to an
additional 35,294 shares of common stock, which became
fully vested and exercisable upon our receipt of FDA approval
for ArteFill on October 27, 2006. The warrant has an
exercise price of $5.31 per share, subject to adjustment,
and may be exercised at any time until the earlier of
June 7, 2009, or the completion of a merger or sale of our
company or the sale of all or substantially all of our assets.
Pursuant to the directors agreement, we also agreed to
reimburse Mr. Reinhard for expenses incurred in connection
with his services as a director.
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In January 2006, we granted Mr. Reinhard an additional
warrant to purchase 35,294 shares of common stock at
an exercise price of $5.31 per share, in consideration for
services in his capacity as Executive Chairman of the Board of
Directors during fiscal 2005. The warrant may be exercised at
any time before January 3, 2011.
Acquisition of Assets from FormMed BioMedicals AG
In July 2004, we acquired assets and intellectual property from
FormMed BioMedicals AG, or FormMed, related to the development
and manufacture of PMMA microspheres used in the production of
ArteFill. This transaction had an effective date of
January 1, 2004. The assets acquired included rights to all
of FormMeds U.S. and international patents, patent
applications and trademarks related to the ArteFill platform
technology and Artes Medical Germany GmbH (formerly MediPlant
GmbH Biomaterials & Medical Devices), a facility for
the manufacture of the PMMA microspheres. The aggregate purchase
price for these assets was approximately $4.3 million,
which was paid in installments through December 2005. We pledged
certain of the acquired patents to FormMed to secure our
obligations with respect to the purchase of the assets. At the
time of the acquisition, Dr. Martin Lemperle was the
controlling shareholder of FormMed. Dr. Martin Lemperle is
the brother of Stefan Lemperle, our former Chief Executive
Officer and a former director. Dr. Martin Lemperle is also a
former director of our company.
Settlement Agreement with FormMed BioMedicals AG and Martin
Lemperle
In October 2005, we entered into a settlement agreement with
FormMed and Dr. Martin Lemperle, pursuant to which we paid
to FormMed an aggregate cash fee of 427,500 Euro in installments
through June 2006, and issued 7,214 shares of common stock
to FormMed in full satisfaction of certain production costs
disputed under the FormMed asset purchase agreement. We also
paid to Dr. Martin Lemperle an aggregate cash fee of
150,000 Euro and issued 2,549 shares of common stock to
Dr. Martin Lemperle in full satisfaction of his claims for
reimbursement of certain legal expenses. In connection with
these transactions, FormMed and Dr. Martin Lemperle entered
into a voting agreement with us, pursuant to which they have
agreed to vote all shares of voting capital stock held by them
as directed by a majority of our board of directors on all
matters presented to a vote of our stockholders.
Issuance of Common Stock to Directors in Consideration for
Personal Guarantees
In December 30, 2005, we amended the terms of certain
convertible promissory notes issued by us in connection with a
bridge financing transaction to, among other things, extend the
maturity date of the notes until February 2006. In connection
with the amendment, three members of our board of directors,
Stefan M. Lemperle, M.D., Christopher J. Reinhard
and Daren J. Barone, agreed to provide personal guarantees
on the debt under the notes. In consideration for the issuance
of these personal guarantees, we agreed to issue to each of
these directors 23,529 shares of common stock, which had a fair
market value $10.41 per share on the date of issuance of the
personal guarantees. We repaid all of the remaining debt under
the notes in February 2006.
Separation and Termination Agreements with Gottfried
Lemperle
In March 2006, we entered into a separation agreement with
Dr. Gottfried Lemperle in connection with his retirement
and resignation as our Vice President of Research and
Development, Chief Scientific Officer and a director. Under the
separation agreement, we agreed to retain Dr. Gottfried
Lemperle as a consultant for an initial term of up to
24 months. In May 2006, we entered into a termination
agreement with Dr. Gottfried Lemperle pursuant to which we
terminated this consulting arrangement. See
Management Employment, Severance and Change of
Control Agreements.
Separation Agreement with Stefan Lemperle
In November 2006, we entered into a separation agreement with
Dr. Stefan M. Lemperle in connection with his resignation as a
director and employee of our company. See
Management Employment, Severance and Change of
Control Agreements.
97
PRINCIPAL STOCKHOLDERS
The following table shows information with respect to the
beneficial ownership of our common stock as of October 31,
2006 by:
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each of our current directors; |
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each of our named executive officers as of December 31,
2005; |
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all of our current directors and executive officers as a
group; and |
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each person or group of affiliated persons or entities known by
us to beneficially own 5% or more of the outstanding shares of
our common stock. |
Beneficial ownership is determined in accordance with the rules
of the SEC. In computing the number of shares beneficially owned
by a person and the percentage ownership of that person, shares
of common stock subject to options and warrants held by that
person that are currently exercisable or exercisable within
60 days of October 31, 2006 are deemed outstanding,
but are not deemed outstanding for computing the percentage
ownership of any other person. Percentage of beneficial
ownership is based on (i) 11,034,343 shares of common
stock outstanding as of October 31, 2006, after giving
effect to the conversion of all shares of our preferred stock
into an aggregate of 9,367,511 shares of our common stock
that will become effective at the closing of this offering and
the issuance of 275,902 shares of common stock upon the exercise
of outstanding warrants contingent and effective upon the
closing of this offering, and (ii) 15,634,343 shares
outstanding immediately after this offering. To our knowledge,
except as set forth in the footnotes to this table and subject
to applicable community property laws, each person named in the
table has sole voting and investment power with respect to the
shares set forth opposite such persons name. Except as
otherwise indicated, the address of each stockholder is
c/o Artes Medical, Inc., 5870 Pacific Center Boulevard,
San Diego, California 92121.
Certain of our existing stockholders have indicated an interest
in purchasing up to approximately 800,000 shares of our
common stock in this offering at the initial public offering
price. However, because indications of interest are not binding
agreements or commitments to purchase, our underwriters may
determine not to sell shares in this offering to our existing
stockholders, or our stockholders may decide not to purchase
shares in this offering. The following table does not reflect
potential purchases by any of our existing stockholders.
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Percentage of shares | |
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beneficially owned | |
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Number of shares | |
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Before | |
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After | |
Name and address of beneficial owner |
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beneficially owned | |
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this offering | |
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this offering | |
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Directors and named executive officers
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Christopher J. Reinhard(1)
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272,533 |
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2.4 |
% |
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1.7% |
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Diane S. Goostree(2)
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27,941 |
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* |
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* |
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Peter C. Wulff(3)
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37,009 |
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* |
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* |
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Stefan M. Lemperle, M.D.(4)
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891,229 |
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7.8 |
% |
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5.6% |
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Gottfried H. Lemperle, M.D., Ph.D.(5)
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403,026 |
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3.6 |
% |
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2.6% |
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William von Brendel(6)
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33,867 |
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* |
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* |
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Daren J. Barone(7)
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149,759 |
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1.4 |
% |
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1.0% |
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Lon E. Otremba(8)
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34,822 |
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* |
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* |
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John R. Costantino(9)
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611,762 |
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5.5 |
% |
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3.9% |
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All directors and executive officers as a group
(12 persons)(10)
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1,265,196 |
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10.9 |
% |
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7.8% |
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* |
Represents beneficial ownership of less than one percent of our
outstanding common stock. |
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(1) |
Includes (i) 46,807 shares held by Christopher J.
Reinhard, (ii) 20,139 shares issuable upon conversion
of preferred stock held by Mr. Reinhard,
(iii) 195,293 shares issuable to Mr. Reinhard upon |
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the exercise of warrants vested as of 60 days following
October 31, 2006 and (iv) 10,294 shares issuable to
Mr. Reinhard upon exercise of options vested as of
60 days following October 31, 2006. |
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(2) |
Includes 27,941 shares issuable to Diane S. Goostree
upon the exercise of options vested as of 60 days following
October 31, 2006. |
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(3) |
Includes 37,009 shares issuable to Peter C. Wulff upon the
exercise of options vested as of 60 days following
October 31, 2006. |
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(4) |
Includes (i) 23,529 shares held by Dr. Stefan M.
Lemperle, (ii) 4,705 shares issuable to
Dr. Stefan Lemperle upon the exercise of warrants vested as
of 60 days following October 31, 2006,
(iii) 117,646 shares issuable to Dr. Stefan
Lemperle upon the exercise of options vested as of 60 days
following October 31, 2006, (iv) 245,294 shares
held by Creative Microspheres, Inc.,
(v) 259,672 shares issuable upon conversion of
preferred stock held by Creative Microspheres, Inc. and
(vi) 240,383 shares issuable to Creative Microspheres,
Inc. upon the exercise of warrants vested as of 60 days
following October 31, 2006. Dr. Stefan Lemperle, our
former Chief Executive Officer and a former director, is the
beneficial owner of the shares held by Creative Microspheres,
Inc. Seyed Hadi Sadr, the director and President of Creative
Microspheres, Inc., has sole voting and investment power with
respect to the shares held by Creative Microspheres, Inc.
Dr. Stefan Lemperle disclaims beneficial ownership of the
shares held by Creative Microspheres, Inc., except to the extent
of his pecuniary interest therein. The address for Creative
Microspheres, Inc. is c/o Sadr & Barrera, APLC,
401 West A Street, Suite 1815, San Diego, CA
92101. |
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(5) |
Includes (i) 56,058 shares issuable to
Dr. Gottfried Lemperle upon the exercise of warrants vested
as of 60 days following October 31, 2006,
(ii) 280,217 shares held by Opal Investments
Management, Inc. and (iii) 66,751 shares issuable upon
conversion of preferred stock held by Opal Investments
Management, Inc. Dr. Gottfried Lemperle, our former Vice
President of Research and Development and Chief Scientific
Officer and a former director, is the beneficial owner of the
shares held by Opal Investments Management, Inc., Seyed Hadi
Sadr, the director and President of Opal Investments Management,
Inc., has sole voting and investment power with respect to the
shares held by Opal Investments Management, Inc.
Dr. Gottfried Lemperle disclaims beneficial ownership of
the shares held by Opal Investments Management, Inc., except to
the extent of his pecuniary interest therein. The address for
Opal Investments Management, Inc. is c/o Sadr &
Barrera, APLC, 401 West A Street, Suite 1815,
San Diego, CA 92101. |
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(6) |
Includes (i) 2,352 shares issuable upon conversion of
preferred stock held by Kristine Jacques and
(ii) 31,515 shares issuable to William von Brendel
upon the exercise of options vested as of 60 days following
October 31, 2006. Kristine Jacques is the wife of
Mr. von Brendel. Mr. von Brendel served as our Vice
President-Worldwide Sales and International Markets until
October 2006. |
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(7) |
Includes (i) 11,765 shares issuable to Daren J. Barone
upon the exercise of warrants vested as of 60 days
following October 31, 2006, (ii) 23,529 shares
issuable to Mr. Barone upon the exercise of options vested
as of 60 days following October 31, 2006,
(iii) 25,925 shares held by DJB Holdings, LLC,
(iv) 43,601 shares issuable upon conversion of
preferred stock held by DJB Holdings, LLC
(v) 18,823 shares issuable to DJB Holdings, LLC upon
the exercise of warrants vested as of 60 days following
October 31, 2006; (vi) 21,764 shares issuable
upon conversion of preferred stock held by WB Partners, LP. and
(vii) 4,352 shares issuable to WB Partners, LP upon
the exercise of warrants vested as of 60 days following
October 31, 2006. Mr. Barone, a member of our board of
directors, is the managing member of DJB Holdings, LLC and has
sole voting and investment power with respect to the shares held
by DJB Holdings, LLC. Mr. Barone and Greg Watkins are
general partners of WB Partners, LP and share voting and
investment power with respect to the shares held by WB Partners,
LP. The address for DJB Holdings, LLC is 5776 Ruffin Road,
San Diego, California 92123. |
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(8) |
Includes (i) 9,411 shares issuable upon conversion of
preferred stock held by Lon E. Otremba,
(ii) 1,882 shares issuable to Mr. Otremba upon
the exercise of warrants vested as of 60 days following
October 31, 2006 and (iii) 23,529 shares issuable
to Mr. Otremba upon the exercise of options vested as of
60 days following October 31, 2006. |
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(9) |
Includes (i) 273,129 shares issuable upon conversion
of preferred stock held by NGN BioMed Opportunity I, L.P.,
(ii) 81,938 shares issuable to NGN BioMed
Opportunity I, L.P. upon the exercise of warrants vested as
of 60 days following October 31, 2006,
(iii) 197,458 shares issuable upon conversion of
preferred stock held by NGN BioMed Opportunity I
GmbH & Co. Beteiligungs KG and
(iv) 59,237 shares issuable to NGN BioMed
Opportunity I GmbH & Co. Beteiligungs KG upon
exercise of warrants vested as of 60 days following
October 31, 2006. NGN BioMed I, GP, L.P., which is the
sole general partner of NGN BioMed Opportunity I, L.P., and
NGN Capital LLC, which is the sole general partner of NGN
BioMed I, GP, L.P. and the managing limited partner of NGN
BioMed Opportunity I, GmbH & Co. Beteiligungs KG,
each may be deemed to share voting and investment power with
respect to all shares held by those entities.
Mr. Costantino is Managing General Partner of NGN Capital
LLC. Mr. Costantino disclaims beneficial ownership of the
shares held by NGN Capital LLC, NGN BioMed Opportunity I,
L.P., NGN BioMed Opportunity I GmbH & Co.
Beteiligungs KG and NGN BioMed I, GP, L.P., except to the
extent of his pecuniary interest therein. |
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(10) |
Excludes shares held by Dr. Stefan Lemperle, who was
removed from his position as an executive officer in October
2006 and resigned as a director in November 2006, shares held by
Dr. Gottfried Lemperle, who resigned as an executive
officer and a director in March 2006, and shares held by
William von Brendel, who was removed from his position
as an executive officer in October 2006. Includes 27,941 shares
issuable to Diane S. Goostree upon the exercise of options
vested as of 60 days following October 31, 2006. |
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DESCRIPTION OF CAPITAL STOCK
The description below of our capital stock and provisions of our
amended and restated certificate of incorporation and amended
and restated bylaws are summaries and are qualified by reference
to the amended and restated certificate of incorporation and the
amended and restated bylaws that will become effective upon
closing of this offering. These documents will be filed as
exhibits to the registration statement of which this prospectus
is a part. The descriptions of the common stock and preferred
stock reflect changes to our capital structure that will occur
upon the completion of this offering.
General
Our amended and restated certificate of incorporation authorizes
the issuance of up to 200,000,000 shares of common stock,
par value $0.001 per share, and 10,000,000 shares of
preferred stock, par value $0.001 per share. The rights and
preferences of any authorized but undesignated preferred stock
may be established from time to time by our board of directors.
As of September 30, 2006, there were issued and outstanding
1,390,930 shares of common stock and 8,915,740 shares
of preferred stock convertible into 9,367,511 shares of
common stock. As of September 30, 2006, we had 61 common
stockholders of record and 845 preferred stockholders of record.
We will have a total of 15,634,343 shares of common stock
outstanding immediately following this offering, assuming:
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4,600,000 shares of common stock offered by us in this
offering; |
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10,758,441 shares of common stock outstanding as of
September 30, 2006 after giving effect to the conversion of
all outstanding shares of our preferred stock into common stock
upon the closing of this offering; |
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107,754 shares of common stock issuable upon the exercise
of preferred stock and common stock warrants outstanding as of
September 30, 2006, which the warrant holders have elected
to exercise in cash, contingent and effective upon the closing
of this offering; and |
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168,148 shares of common stock issuable upon the exercise
of preferred stock and common stock warrants outstanding as of
September 30, 2006, which the warrant holders have elected
to exercise through the cashless exercise provisions
of the warrants, based on the initial public offering price of
$6.00 per share. |
Common Stock
Each holder of common stock is entitled to one vote for each
share on all matters submitted to a vote of the stockholders,
except matters that relate only to one or more of the series of
preferred stock and each holder does not have cumulative voting
rights. Accordingly, the holders of a majority of the shares of
common stock entitled to vote in any election of directors can
elect all of the directors standing for election, if they so
choose.
Subject to preferences that may be applicable to any then
outstanding preferred stock, holders of common stock are
entitled to receive ratably those dividends, if any, as may be
declared from time to time by the board of directors out of
legally available funds.
Holders of common stock have no preemptive or conversion rights
or other subscription rights, and there are no redemption or
sinking fund provisions applicable to the common stock. All
outstanding shares of common stock are fully paid and
nonassessable. The rights, preferences and privileges of the
holders of common stock are subject to, and may be adversely
affected by, the rights of the holders of shares of any series
of preferred stock currently existing or which we may designate
in the future.
101
Preferred Stock
Upon the completion of this offering, all outstanding shares of
preferred stock will be converted into an aggregate of
9,367,511 shares of common stock. Under our amended and
restated certificate of incorporation, our board of directors
will be authorized, subject to any limitations prescribed by
law, without stockholder approval, to issue up to an aggregate
of 10,000,000 shares of preferred stock in one or more
series and to fix the rights, preferences, privileges and
restrictions granted to or imposed upon the preferred stock,
including voting rights, dividend rights, conversion rights,
redemption privileges and liquidation preferences. The rights of
the holders of common stock will be subject to, and may be
adversely affected by, the rights of holders of any preferred
stock that may be issued in the future. The issuance of
preferred stock, while providing flexibility in connection with
possible acquisitions and other corporate purposes, could have
the effect of delaying, deferring or preventing a change in
control of our company. We have no present plans to issue any
shares of preferred stock.
Warrants
As of September 30, 2006, we had outstanding warrants to
purchase 2,490,189 shares of common stock, at a weighted
average exercise price of $6.98 per share. Of these warrants:
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warrants to purchase 78,817 shares of common stock must be
exercised in cash at any time prior to March 15, 2007; |
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warrants to purchase 1,189,432 shares of common stock must be
exercised in cash at any time prior to the expiration date of
the warrant, which is typically five years from the date of
issuance; and |
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warrants to purchase 1,221,940 shares of common stock that may
be exercised in cash or through cashless exercise
provisions of the warrants at any time prior to the expiration
date of the warrant, which is typically five years from the date
of issuance. |
In addition, in November 2006, we granted Comerica Bank a
warrant to purchase 28,235 shares of common stock at an
exercise price of $10.63 per share. This warrant may be
exercised any time prior to November 2016.
These warrant numbers do not include the following shares of
common stock issuable upon the closing of this offering:
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107,754 shares of common stock issuable upon the exercise
of preferred stock and common stock warrants outstanding as of
September 30, 2006, which the warrant holders have elected
to exercise in cash, contingent and effective upon the closing
of this offering; and |
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168,148 shares of common stock issuable upon the exercise
of preferred stock and common stock warrants outstanding as of
September 30, 2006, which the warrant holders have elected
to exercise through the cashless exercise provisions
of the warrants, based on the initial public offering price of
$6.00 per share. |
Stock Options
As of September 30, 2006, there were outstanding options to
purchase 1,869,676 shares of common stock, at a weighted
average exercise price of $5.85 per share, including options to
purchase 1,813,916 shares of common stock issued under our
2001 Stock Option Plan and 55,760 shares of common stock
issued under our 2000 Stock Option Plan and pursuant to
individual stock option agreements. In addition, in November
2006, we issued options to purchase up to 335,246 shares of
common stock, at a weighted average exercise price of $10.63 per
share, under our 2001 Stock Option Plan. We have also reserved
an additional 3,640,843 shares of common stock for future grant
under our 2006 Equity Incentive Plan, which will become
effective upon the closing of this offering.
Registration Rights
After the offering, the holders of an aggregate of
11,606,882 shares of our outstanding common stock and
shares of common stock issuable upon exercise of outstanding
warrants are entitled to certain registration
102
rights under an amended and restated investor rights agreement
we entered into with these holders. The amended and restated
investor rights agreement provides these stockholders with
customary demand, piggyback and
Form S-3
registration rights with respect to the shares of our common
stock that will be issued to them upon conversion of our
preferred stock upon the effectiveness of this registration
statement.
Under the terms of the amended and restated investor rights
agreement, holders of at least a majority of (i) the shares
of common stock issued upon conversion of our preferred stock,
including shares of preferred stock issuable upon the exercise
of warrants to purchase preferred stock issued in our prior
financing transactions and (ii) shares of common stock
issuable upon the exercise of warrants to purchase common stock
issued in our prior financing transactions, which we refer to as
registrable securities, will have the right to require us to
register their shares with the SEC for resale to the public. The
holders of our preferred stock will be entitled to exercise this
right at any time beginning on the earlier of January 1,
2008 or 180 days after the effective date of this
registration statement. In both cases, however, the registered
offering must be fully underwritten and the aggregate gross
proceeds, prior to deduction for underwriters discounts
and expenses, must exceed $25,000,000. Under the investor rights
agreement, we will not be required to effect more than two
demand registrations. We currently have not effected, or
received a request to effect, any demand registrations under our
existing investor rights agreements.
Under the terms of the amended and restated investor rights
agreement, if we file a registration statement for a public
offering of any of our securities (either for our own account or
upon exercise of demand registration rights) on a form that
would be suitable for a registration involving registrable
common stock, holders of registrable securities will have the
right to include their shares in the registration statement,
subject to certain limitations. These piggyback
registration rights will be exercisable beginning on the earlier
of January 1, 2008 or 180 days after the effective
date of this registration statement.
Under the terms of the amended and restated investor rights
agreement, at any time after we become eligible to file a
registration statement on
Form S-3, holders
of 30% of the registrable securities will be entitled to require
us to file a registration statement on
Form S-3; provided
that the aggregate gross proceeds of an offering pursuant to a
Form S-3
registration must be at least $1,000,000.
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Conditions and limitations; delay |
The registration rights described above will be subject to
certain conditions and limitations, including the right of the
underwriters of an offering to limit the number of shares to be
included in the registration. In the event any registered
offering involves an underwriting, each stockholders right
to participate in the offering is conditioned upon that
stockholders participation in the underwriting. In
addition, we will have the right to delay a demand registration
or request for registration on
Form S-3 during
certain periods before and after the filing of registration
statements by us, other than registrations of securities in
Rule 145 transactions or with respect to employee benefit
plans. We may also delay such registrations for one period not
to exceed 120 days in any
12-month period if our
board of directors believes it would be seriously detrimental to
us or our stockholders to file a registration statement.
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Expenses; indemnification |
We are generally required to bear the expenses of all
registrations, including reasonable fees and expenses of a
single counsel acting on behalf of all selling stockholders,
except underwriting discounts and selling commissions. The
amended and restated investor rights agreement also will contain
our commitment to indemnify the holders of registration rights
for losses attributable to statements or omissions by us
incurred with registrations under the agreement.
103
The registration rights granted under the amended and restated
investor rights agreement will terminate, with respect to each
holder of such registration rights, upon the earlier of
(i) five years following the closing of our initial public
offering and (ii) the date on which any holder of such
rights is eligible to sell such holders registrable common
stock under Rule 144 of the Securities Act within any
ninety-day period.
Anti-Takeover Effects of Provisions of Our Amended and
Restated Certificate of Incorporation and Bylaws and Delaware
Law
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Amended and restated certificate of incorporation and
bylaws |
Some provisions of Delaware law and our amended and restated
certificate of incorporation and bylaws contain provisions that
could make the following transactions more difficult:
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acquisition of us by means of a tender offer; |
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acquisition of us by means of a proxy contest or
otherwise; or |
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removal of our incumbent officers and directors. |
These provisions, summarized below, are expected to discourage
coercive takeover practices and inadequate takeover bids and to
promote stability in our management.
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Stockholder meetings. Our charter documents provide that
a special meeting of stockholders may be called only by a
resolution adopted by a majority of our board of directors. |
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Elimination of stockholder action by written consent. Our
amended and restated certificate of incorporation eliminates the
right of stockholders to act by written consent without a
meeting. |
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Undesignated preferred stock. The ability to authorize
undesignated preferred stock makes it possible for our board of
directors to issue one or more series of preferred stock with
voting or other rights or preferences that could impede the
success of any attempt to change control of our company. These
and other provisions may have the effect of deterring hostile
takeovers or delaying changes in control or management of our
company. |
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Requirements for advance notification of stockholder
nominations and proposals. Our bylaws establish advance
notice procedures with respect to stockholder proposals and the
nomination of candidates for election as directors, other than
nominations made by or at the direction of the board of
directors or a committee of the board of directors. |
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Amendment of bylaws. Any amendment of our bylaws by our
stockholders requires approval by holders of at least
66 2/3% of our then outstanding common stock, voting
together as a single class. |
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Staggered board. Our amended and restated certificate of
incorporation provides for the division of our board of
directors into three classes, as nearly equal in size as
possible, with staggered three-year terms. Under our amended and
restated certificate of incorporation and amended and restated
bylaws, any vacancy on the board of directors resulting from
death, resignation, removal, or other causes, other than a
vacancy with respect to a director who must be elected by the
holders of any class or series of stock (either in general or
under specified circumstances), may only be filled by either
(i) the affirmative vote of the holders of a majority of
the voting power of the then-outstanding shares of voting stock
of the Company entitled to vote generally in the election of
directors, voting together as a single class; or (ii) the
affirmative vote of a majority of the remaining directors then
in office, even though less than a quorum of the Board of
Directors. Subject to the rights of any class or series of stock
then outstanding, newly created directorships resulting from any
increase in the number of directors shall, unless the Board of
Directors determines by resolution that any such newly created
directorship shall be filled by the stockholders, be filled only
by the affirmative vote of the directors then in office, even
though less than a quorum of the Board of Directors, or by a
sole remaining director. The classification of the board of
directors and the limitations on the removal of directors and |
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filling of vacancies would have the effect of making it more
difficult for a third party to acquire control of us or of
discouraging a third party from acquiring control of us. |
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Amendment of amended and restated certificate of
incorporation. Amendments to certain provisions of our
amended and restated certificate of incorporation require
approval by holders of at least 66 2/3% of our then
outstanding common stock, voting together as a single class. |
These provisions are also designed to encourage persons seeking
to acquire control of us to first negotiate with our board of
directors.
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Delaware anti-takeover statute |
We are subject to Section 203 of the Delaware General
Corporation Law. This law prohibits a publicly held Delaware
corporation from engaging in any business combination with any
interested stockholder for a period of three years following the
date that the stockholder became an interested stockholder
unless:
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prior to the date of the transaction, the board of directors of
the corporation approved either the business combination or the
transaction which resulted in the stockholder becoming an
interested stockholder; |
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upon completion of the transaction which resulted in the
stockholder becoming an interested stockholder, the interested
stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the number of shares
outstanding those shares owned by persons who are directors and
also officers and by employee stock plans in which employee
participants do not have the right to determine confidentially
whether shares held subject to the plan will be tendered in a
tender or exchange offer; or |
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on or subsequent to the date of the transaction, the business
combination is approved by the board of directors and authorized
at an annual or special meeting of stockholders, and not by
written consent, by the affirmative vote of at least two-thirds
of the outstanding voting stock which is not owned by the
interested stockholder. |
Section 203 defines business combination to
include:
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any merger or consolidation involving the corporation and the
interested stockholder; |
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any sale, transfer, pledge or other disposition of 10% or more
of our assets involving the interested stockholder; |
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in general, any transaction that results in the issuance or
transfer by us of any of our stock to the interested stockholder; |
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in general, any transaction involving the corporation that has
the effect, directly or indirectly, of increasing the
proportionate share of our stock owned by the interested
stockholder; or |
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the receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation. |
In general, Section 203 defines an interested
stockholder as an entity or person beneficially owning 15%
or more of the outstanding voting stock of the corporation and
any entity or person affiliated with or controlling or
controlled by the entity or person.
Our amended and restated certificate of incorporation provides
that no director shall be personally liable to us or to our
stockholders for monetary damages for breach of fiduciary duty
as a director, except that the limitation shall not eliminate or
limit liability to the extent that the elimination or limitation
of such liability is not permitted by the Delaware General
Corporation Law as the same exists or may hereafter be amended.
105
The Nasdaq Global Market
Our common stock has been approved for listing on the Nasdaq
Global Market under the symbol ARTE.
Transfer Agent And Registrar
The transfer agent and registrar for our common stock is Mellon
Investor Services LLC. Its address is 400 South Hope Street, 4th
Floor, Los Angeles, CA 90071, and its telephone number is
(213) 553-9700.
106
SHARES ELIGIBLE FOR FUTURE SALE
Prior to this offering, there has been no public market for our
common stock, and we cannot assure you that a significant public
market for our common stock will develop or be sustained after
this offering. Future sales of substantial amounts of our common
stock, including shares of our outstanding common stock and
shares of our common stock issued upon exercise of outstanding
options and warrants, in the public market after this offering,
or the perception that these sales could occur, could adversely
affect the prevailing market price of our common stock and could
impair our future ability to raise capital through the sale of
equity securities.
Sale of Restricted Shares
Based on the number of shares outstanding as of
September 30, 2006, we will have approximately
15,634,343 shares of common stock outstanding after the
completion of this offering, and approximately
16,324,343 shares if the underwriters exercise their
over-allotment option in full. Of these shares, the
4,600,000 shares of common stock sold in this offering,
plus the additional 690,000 shares if the underwriters
exercise their over-allotment option in full, will be freely
transferable without restriction, unless purchased by our
affiliates, as that term is defined under Rule 144 of the
Securities Act of 1933, as amended.
The remaining 11,034,343 shares of common stock to be
outstanding immediately following the completion of this
offering, which are restricted securities, as well
as any other shares held by our affiliates, may not be resold
except pursuant to an effective registration statement or an
applicable exemption from registration, including an exemption
under Rule 144, Rule 144(k) or Rule 701 of the
Securities Act. As of the date of this prospectus, these
outstanding shares will be eligible for sale as follows:
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321,823 shares of common stock that are not subject to the
180-day
lock-up period
described below will be immediately eligible for sale in the
public market under Rule 144 or Rule 144(k) upon the
effective date of the registration statement of which this
prospectus is a part; and |
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10,712,520 shares of common stock that are subject to the
180-day
lock-up period
described below will be eligible for sale in the public market
under Rule 144, Rule 144(k) or Rule 701,
immediately upon expiration of the
180-day
lock-up period
described below, subject to the volume, manner of sale and other
limitations under those rules. |
Lock-Up Agreements
The holders of substantially all of our securities outstanding
prior to the closing of this offering, including all of our
officers and directors, have entered into
lock-up agreements with
the underwriters, or are subject to contractual arrangements
with us, pursuant to which they have generally agreed, subject
to certain exceptions, not to, without the prior written
approval of Cowen and Company, LLC and Lazard Capital Markets
LLC or us, as applicable, offer, sell, contract to sell or
otherwise dispose of, directly or indirectly, or hedge our
common stock or securities convertible into or exchangeable or
exercisable for our common stock. These restrictions will be in
effect for a period of 180 days after the date of this
prospectus. This
180-day
lock-up period with
respect to the lock-up
agreements with the underwriters and the contractual
lock-up arrangements
between us and our securityholders, for all but approximately
375,000 shares of common stock, may be extended under
certain circumstances where we release, or pre-announce a
release of, our earnings or material news or a material event
shortly before or after the termination of the
180-day period. At any
time and without public notice, Cowen and Company, LLC and
Lazard Capital Markets LLC may, in their discretion, release all
or some of the securities from their
lock-up agreements. The
180-day
lock-up period in the
lock-up agreements with the underwriters shall not apply to the
shares of common stock purchased by our securityholders, who are
not officers and directors, from the underwriters participating
in this offering or under the directed share program discussed
below. See Underwriting.
Neither Rule 144, Rule 144(k) nor Rule 701
described below supersede the contractual obligations of our
security holders set forth in the
lock-up agreements
described above.
107
Registration Rights
After the offering, the holders of an aggregate of
11,606,882 shares of outstanding common stock and shares of
common stock issuable upon exercise of outstanding warrants are
entitled to certain registration rights. By exercising their
registration rights and causing a large number of shares to be
registered and sold in the public market, these holders could
cause the price of our common stock to fall. In addition, any
demand to include their shares in our registration statements
could harm our ability to raise needed capital. For more
information on these registration rights, see Description
of Capital Stock Registration Rights.
Rule 144
In general, under Rule 144, as currently in effect, an
affiliate of ours who beneficially owns shares of our common
stock that are not restricted securities, or a person who
beneficially owns for more than one year shares of our common
stock that are restricted securities, may generally sell, within
any three month period, a number of shares that does not
exceed the greater of:
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1% of the number of shares of our common stock then outstanding,
which will equal approximately 156,343 shares immediately
after this offering (approximately 163,243 shares if the
underwriters exercise their over-allotment option in
full); and |
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the average weekly trading volume of our common stock on the
Nasdaq Global Market during the four preceding calendar weeks. |
Sales under Rule 144 are also subject to requirements with
respect to manner of sale, notice and the availability of
current public information about us.
Rule 144(k)
A person who was not our affiliate at any time during the three
months before the sale, and who has beneficially owned shares of
our common stock that are restricted securities for at least two
years, may sell those shares without regard to the volume
limitations, manner of sale provisions, notice requirements or
the requirements with respect to availability of current public
information about us. Affiliates must always sell pursuant to
Rule 144, even after the applicable holding periods have
expired.
Rule 701
Generally, an employee, officer, director or consultant who
purchased shares of our common stock before the effective date
of the registration statement of which this prospectus is a
part, or who holds options as of that date, pursuant to a
written compensatory plan or contract, may rely on the resale
provisions of Rule 701 under the Securities Act. Under
Rule 701, these persons who are not our affiliates may
generally sell their eligible securities, commencing
90 days after the effective date of the registration
statement of which this prospectus is a part, without having to
comply with the public information, holding period, volume
limitation or notice provisions of Rule 144. These persons
who are our affiliates may generally sell their eligible
securities under Rule 701, commencing 90 days after
the effective date of the registration statement of which this
prospectus is a part, without having to comply with
Rule 144s one-year holding period restriction.
Warrants
There were outstanding warrants to purchase
2,490,189 shares of our common stock, as of
September 30, 2006, after giving effect to the assumed
issuance of 275,902 shares of common stock upon the
exercise of warrants contingent and effective upon the closing
of this offering. In addition, in November 2006, we granted a
warrant to purchase 28,235 shares of common stock. Any
shares of common stock acquired upon the exercise of these
warrants after the completion of this offering will become
eligible for sale in accordance with Rule 144 or
Rule 144(k) after the date of exercise and subject to the
expiration of applicable contractual lock-up or market standoff
periods. As of the date of this prospectus, the holders of
outstanding warrants to purchase 38,234 shares of common
stock are not subject to lock-up agreements or other contractual
lock-up provisions.
108
Stock Options
There were outstanding options to purchase 1,869,676 shares of
our common stock, as of September 30, 2006. In November
2006, we granted options to purchase 335,246 shares of
common stock. In addition, we have reserved an additional
3,640,843 shares of our common stock for issuance under our
2006 Equity Incentive Plan, which will become effective on the
closing of this offering. We intend to register, under the
Securities Act of 1933, the shares of common stock underlying
these outstanding stock options and the shares of common stock
reserved for issuance under our 2006 Equity Incentive Plan on a
registration statement on
Form S-8 following
this offering. Subject to the
lock-up agreements,
vesting restrictions and the restrictions imposed under our
stock option plans, shares of common stock issued under our
stock option plans after the effective date of any registration
statement on
Form S-8 will be
available for sale in the public market without restriction to
the extent that they are held by persons who are not our
affiliates. As of the date of this prospectus, the holders of
outstanding options to purchase 88,952 shares of common
stock are not subject to lock-up agreements or other contractual
lock-up provisions.
109
MATERIAL UNITED STATES FEDERAL INCOME TAX CONSIDERATIONS
FOR
NON-U.S. HOLDERS OF OUR COMMON STOCK
The following discussion of certain material United States
federal income tax considerations relevant to
Non-U.S. Holders
(as defined below) of our common stock is for general
information only. Accordingly, all prospective
Non-U.S. Holders
of our common stock are urged to consult their own tax advisors
with respect to the U.S. federal, state and local and
foreign tax consequences of the acquisition, ownership and
disposition of our common stock.
As used in this prospectus, the term
Non-U.S. Holder
is a person who is an owner of our common stock other than:
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a citizen or resident of the United States; |
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a corporation or other entity taxable as a corporation for
U.S. federal income tax purposes created or organized in or
under the laws of the United States or of any political
subdivision of the United States; |
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an estate the income of which is includable in gross income for
United States federal income tax purposes regardless of its
source; or |
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a trust subject to the primary supervision of a U.S. court
and the control of one or more U.S. persons, or a trust
(other than a wholly owned grantor trust) that was treated as a
domestic trust despite not meeting the requirements described
above. |
This discussion does not address:
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U.S. federal income, estate or gift tax consequences other
than as expressly set forth below; |
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state, local or foreign tax consequences; |
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the tax consequences for the stockholders, beneficiaries or
holders of other beneficial interests in a
Non-U.S. Holder; |
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special tax rules that may apply to selected
Non-U.S. Holders,
including without limitation,
non-U.S. holders
of interests in domestic or foreign partnerships, partnerships,
banks or other financial institutions, insurance companies,
dealers in securities, traders in securities, tax-exempt
entities and United States expatriates; or |
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special tax rules that may apply to a
Non-U.S. Holder
that holds our common stock as part of a straddle, hedge,
conversion, synthetic security, or constructive sale transaction
for United States federal income tax purposes, or a
Non-U.S. Holder
that does not hold our common stock as a capital asset within
the meaning of Section 1221 of the United States Internal
Revenue Code of 1986, as amended, or the Code. |
If a partnership, including any entity treated as a partnership
for U.S. federal income tax purposes, is a holder, the tax
treatment of a partner in the partnership will generally depend
upon the status of the partner and the activities of the
partnership. A holder that is a partnership, and partners in
such partnership, should consult their own tax advisors
regarding the tax consequences of the purchase, ownership and
disposition of our common stock.
The following discussion is based on provisions of the Code,
applicable Treasury regulations and administrative and judicial
interpretations, all as of the date of this prospectus, and all
of which are subject to change, retroactively or prospectively.
We have not requested a ruling from the United States Internal
Revenue Service or an opinion of counsel with respect to the
United States federal income tax consequences of the purchase or
ownership of our common stock to a
Non-U.S. Holder.
There can be no assurance that the U.S. Internal Revenue
Service will not take a position contrary to such statements or
that any such contrary position taken by the U.S. Internal
Revenue Service would not be sustained.
YOU ARE URGED TO CONSULT YOUR TAX ADVISOR WITH RESPECT TO THE
APPLICATION OF THE U.S. FEDERAL INCOME TAX LAWS TO YOUR
PARTICULAR SITUATION
110
AS WELL AS ANY TAX CONSEQUENCES ARISING UNDER THE
U.S. FEDERAL ESTATE OR GIFT TAX RULES OR UNDER THE
LAWS OF ANY STATE, LOCAL, FOREIGN OR OTHER TAXING JURISDICTION
OR UNDER ANY APPLICABLE TAX TREATY.
Dividends
We do not anticipate paying cash dividends on our common stock
in the foreseeable future. See Dividend Policy. In
the event, however, that distributions are made on shares of our
common stock, such distributions paid to a
Non-U.S. Holder
generally will be subject to withholding of U.S. federal income
tax at a 30% rate on the gross amount of the distribution or
such lower rate as may be provided by an applicable income tax
treaty.
Dividends that are effectively connected with a
Non-U.S. Holders
conduct of a trade or business in the United States or
attributable to a permanent establishment in the United States
under an applicable income tax treaty, known as United
States trade or business income, are generally not subject
to the 30% withholding tax if the
Non-U.S. Holder
files the appropriate United States Internal Revenue Service
form with the payor. However, such U.S. trade or business
income, net of specified deductions and credits, is taxed at the
same graduated rates applicable to U.S. persons. Any
U.S. trade or business income received by a
Non-U.S. Holder
that is a corporation may also, under certain circumstances, be
subject to an additional branch profits tax at a 30%
rate or such lower rate as specified by an applicable income tax
treaty.
A Non-U.S. Holder
of our common stock who claims the benefit of an applicable
income tax treaty generally will be required to satisfy
applicable certification and other requirements prior to the
distribution date.
Non-U.S. Holders
are urged to consult their own tax advisors regarding their
entitlement to benefits under a relevant income tax treaty.
A Non-U.S. Holder
that is eligible for a reduced rate of U.S. withholding tax or
other exclusion from withholding under an income tax treaty but
that did not timely provide required certifications or other
requirements, or that has received a distribution subject to
withholding in excess of the amount properly treated as a
dividend, may generally obtain a refund or credit of any excess
amounts withheld by filing an appropriate claim for a refund
with the United States Internal Revenue Service.
Gain on Disposition of Common Stock
A Non-U.S. Holder
generally will not be subject to U.S. federal income tax in
respect of gain recognized on a disposition of our common stock
unless:
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the gain is U.S. trade or business income, in which case
the regular corporate income tax and the branch profits tax
described above may apply to a corporate
Non-U.S. Holder; |
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the
Non-U.S. Holder is
an individual who is present in the United States for more than
182 days in the taxable year of the disposition and meets
other requirements; |
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the
Non-U.S. Holder is
subject to tax pursuant to the provisions of the U.S. tax
law applicable to selected U.S. expatriates; or |
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we are or have been a United States real property holding
corporation for U.S. federal income tax purposes at any
time during the shorter of the five-year period ending on the
date of disposition or the period that the
Non-U.S. Holder
held our common stock. |
Generally, a corporation is a United States real property
holding corporation if the fair market value of its
United States real property interests equals or
exceeds 50% of the sum of the fair market value of its worldwide
real property interests plus its other assets used or held for
use in a trade or business. The tax imposed on stock in a
United States real property holding corporation
generally will not apply to a
Non-U.S. Holder
whose holdings, direct or indirect, have not exceeded 5% of our
common stock. We believe we have never been, are not currently,
and are not likely to become a U.S. real property holding
corporation for U.S. federal income tax purposes.
111
Federal Estate Tax
Common stock owned or treated as owned by an individual who is a
Non-U.S. Holder at
the time of death will be included in the individuals
gross estate for U.S. federal estate tax purposes, unless an
applicable estate tax or other treaty provides otherwise.
Information Reporting and Backup Withholding Tax
We must report annually to the United States Internal Revenue
Service and to each
Non-U.S. Holder
the amount of dividends paid to such holder and the tax withheld
with respect to such dividends. Copies of the information
returns reporting dividends and withholding may also be made
available to the tax authorities in the country in which the
Non-U.S. Holder is
a resident under the provisions of an applicable income tax
treaty or other agreement.
U.S. federal backup withholding generally will not apply to
payments of dividends made by us or our paying agents, in their
capacities as such, to a
Non-U.S. Holder of
our common stock, if the holder has provided the required
certification, under penalties of perjury, as to its
Non-U.S. Holder
status in accordance with applicable United States Treasury
Regulations.
The payment of the proceeds of the disposition of our common
stock by a holder to or through a U.S. office of a broker,
or through a foreign office of a broker who is a U.S. person or
a United States related person (as defined
below) generally will be subject to information reporting and
backup withholding tax unless the holder provides the requisite
certification of status as a
Non-U.S. Holder,
the broker has documentary evidence in its files that the holder
is a
Non-U.S. Holder
and the broker has no actual knowledge, or reason to know, to
the contrary or another exemption is established. For this
purpose, a United States related person is:
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a controlled foreign corporation for U.S. federal
income tax purposes; |
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a foreign partnership if, at any time during the taxable year,
(A) U.S. persons own more than 50% of the income or capital
interests in the partnership, or (B) the partnership is
engaged in a United States trade or business; |
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a foreign person 50% or more of whose gross income from all
sources for the three-year period ending with the close of its
taxable year preceding the payment, (or for such part of the
period that the person has been in existence), is derived from
activities that are effectively connected with the conduct of a
United States trade or business; or |
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some U.S. branches of foreign banks or insurance companies. |
Any amounts withheld under the backup withholding rules from a
payment to a
Non-U.S. Holder
that result in an overpayment of taxes will generally be
refunded, or credited against the holders U.S. federal
income tax liability, if any, provided that the required
information is furnished to the U.S. Internal Revenue Service.
112
UNDERWRITING
The underwriters named below, for whom Cowen and Company, LLC
and Lazard Capital Markets LLC are acting as representatives,
have agreed to purchase, subject to the terms of an underwriting
agreement, the number of shares listed opposite their names
below. The underwriters are committed to purchase and pay for
all of the shares if any are purchased, other than those shares
covered by the over-allotment option described below.
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Number | |
Underwriters |
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of Shares | |
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Cowen and Company, LLC
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1,812,400 |
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Lazard Capital Markets LLC
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1,812,400 |
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Stifel, Nicolaus & Company, Incorporated
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906,200 |
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National Securities Corporation
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23,000 |
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Maxim Group LLC
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23,000 |
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WBB Securities, LLC
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23,000 |
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Total
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4,600,000 |
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The underwriting agreement provides that the obligations of the
several underwriters to purchase shares of our common stock are
subject to the satisfaction of the conditions contained in the
underwriting agreement, which include that:
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the registration statement of which this prospectus is a part
has been declared effective; |
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the representations and warranties made by us to the
underwriters are true; |
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there is no material adverse change in our business; |
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the shares of our common stock to be sold in this offering have
been approved for listing on the Nasdaq Global Market; and |
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we deliver customary closing documents to the underwriters. |
The underwriters have advised us that they propose to offer the
shares initially to the public at $6.00 per share. The
underwriters propose to offer the shares to certain dealers at
the same price less a concession of not more than $0.22 per
share. The underwriters may allow and the dealers may reallow a
concession of not more than $0.10 per share on sales to
certain other brokers and dealers. After this offering, these
figures may be changed by the underwriters.
Certain of our stockholders have indicated an interest in
purchasing up to approximately 800,000 shares of our common
stock in this offering at the initial public offering price.
However, because indications of interest are not binding
agreements or commitments to purchase, the underwriters may
determine not to sell shares in this offering to our existing
stockholders, or our stockholders may decide not to purchase
shares in this offering.
We have granted to the underwriters an over-allotment option to
purchase up to an additional 690,000 shares of our common
stock from us at the same price as to the public, and with the
same underwriting discount, as set forth on the front cover of
this prospectus. The underwriters may exercise this option any
time during the 30-day
period after the date of this prospectus, but only to cover
over-allotments, if any. To the extent the underwriters exercise
the option, each underwriter will become obligated, subject to
certain conditions, to purchase approximately the same
percentage of the additional shares as it was obligated to
purchase under the underwriting agreement.
113
The following table shows the underwriting discounts and
commissions to be paid to the underwriters in connection with
this offering. These amounts are shown assuming both no exercise
and full exercise of the over-allotment option.
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No Exercise | |
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Full Exercise | |
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Per share
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$ |
0.42 |
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$ |
0.42 |
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Total to be paid by us
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$ |
1,932,000 |
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$ |
2,221,800 |
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We estimate that the total expenses of this offering payable by
us, excluding underwriting discounts and commissions, will be
approximately $3,774,000. We have agreed to indemnify the
underwriters against certain liabilities that may be based upon
an untrue statement of material fact contained in this
prospectus, including civil liabilities under the Securities
Act, or to contribute to payments that the underwriters may be
required to make in respect of those liabilities.
The underwriters have informed us that neither they, nor any
other underwriter participating in the distribution of this
offering, will make sales of our common stock offered by this
prospectus to accounts over which they exercise discretionary
authority without the prior specific written approval of the
customer.
The offering of our shares of common stock is made for delivery
when and if accepted by the underwriters and subject to prior
sale and to withdrawal, cancellation, or modification of this
offering without notice. The underwriters reserve the right to
reject an order for the purchase of shares in whole or part.
We and each of our directors, executive officers, and our
security holders collectively beneficially owning substantially
all of our outstanding securities, have entered into lock-up
agreements with the underwriters or are subject to contractual
arrangements with us providing that they will not offer, pledge,
sell, contract to sell, sell any option or contract to purchase,
purchase any option or contract to sell, grant any option,
right, or warrant to purchase, lend, or otherwise transfer or
dispose of, directly or indirectly, any shares of our common
stock or any securities convertible into or exercisable or
exchangeable for our common stock, or enter into any swap or
other arrangement that transfers to another, in whole or in
part, any of the economic consequences of ownership of our
common stock, whether any transaction is to be settled by
delivery of common stock or other securities, in cash or
otherwise, without the prior written consent of Cowen and
Company, LLC and Lazard Capital Markets LLC or us, as
applicable, for a period of 180 days after the date of this
prospectus.
Notwithstanding the foregoing, for the purpose of allowing the
underwriters to comply with NASD Rule 2711(f)(4), if
(1) during the last 17 days of the initial
180-day
lock-up period, we
release earnings results or material news or a material event
relating to us occurs or (2) prior to the expiration of the
initial 180-day
lock-up period, we
announce that we will release earnings results during the
16-day period beginning
on the last day of the initial
180-day
lock-up period, then in
each case the initial
180-day
lock-up period with
respect to the lock-up agreements between the underwriters and
our security holders and the contractual lock-up arrangements
between us and our security holders, for all but approximately
375,000 shares of common stock, may be extended until the
expiration of the
18-day period beginning
on the date of release of the earnings results or the occurrence
of the material news or material event, as applicable.
The lock-up agreements and the contractual arrangements do not
prevent a security holder from transferring such securities by
bona fide gift or by will or intestate succession to his or her
immediate family or to a trust, the sole beneficiary of which is
one or more of the security holder and his or her immediate
family. Cowen and Company, LLC and Lazard Capital Markets LLC
may waive their lock-up restrictions without public notice. Our
lock-up agreement with the underwriters does not limit our
ability to grant options to purchase common stock under our
stock option plans.
The 180-day lock-up
period in the lock-up agreement with the underwriters shall not
apply to the shares of common stock purchased by our security
holders, who are not officers or directors, from the
underwriters participating in this offering or under the
directed share program discussed below.
114
Prior to this offering, there has been no established trading
market for our common stock. The initial public offering price
for the shares of our common stock offered by this prospectus
was negotiated between us and the underwriters immediately prior
to this offering. Factors considered in determining the initial
public offering price included:
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the history of, and the prospects for, the industry in which we
compete; |
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our past and present operations; |
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our historical results of operations; |
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our prospects for future earnings; |
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the recent market prices of securities of generally comparable
companies; and |
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the general condition of the securities markets at the time of
this offering and other relevant factors. |
The initial public offering price of our common stock may not
correspond to the price at which our common stock will trade in
the public market subsequent to this offering, and an active
public market for our common stock may never develop or, if it
does develop, continue after this offering.
To facilitate this offering, the underwriters may engage in
transactions that stabilize, maintain, or otherwise affect the
price of our common stock during and after this offering.
Specifically, the underwriters may over-allot or otherwise
create a short position in our common stock for their own
account by selling more shares of our common stock than have
been sold to them by us. Short sales involve the sale by the
underwriters of a greater number of shares than they are
required to purchase in this offering. Covered short
sales are sales made in an amount not greater than the
underwriters option to purchase additional shares from us
in this offering. The underwriters may close out any covered
short position by either exercising their option to purchase
additional shares or purchasing shares in the open market. In
determining the source of shares to close out the covered short
position, the underwriters will consider, among other things,
the price of shares available for purchase in the open market as
compared to the price at which they may purchase shares through
the over-allotment option. Naked short sales are
sales in excess of this option. The underwriters must close out
any naked short position by purchasing shares in the open
market. A naked short position is more likely to be created if
the underwriters are concerned that there may be downward
pressure on the price of our common stock in the open market
after pricing that could adversely affect investors who purchase
in this offering.
In addition, the underwriters may stabilize or maintain the
price of our common stock by bidding for or purchasing shares of
our common stock in the open market and may impose penalty bids.
If penalty bids are imposed, selling concessions allowed to
syndicate members or other broker-dealers participating in this
offering are reclaimed if shares of our common stock previously
distributed in this offering are repurchased, whether in
connection with stabilization transactions or otherwise.
The effect of these transactions may be to stabilize or maintain
the market price of our common stock at a level above that which
might otherwise prevail in the open market. The imposition of a
penalty bid may also affect the price of our common stock to the
extent that it discourages resales of our common stock. The
magnitude or effect of any stabilization or other transactions
is uncertain. These transactions may be effected on the Nasdaq
Global Market or otherwise and, if commenced, may be
discontinued at any time.
A prospectus in electronic format may be made available on the
Internet sites or through other online services maintained by
the underwriters participating in this offering or by their
affiliates. In those cases, prospective investors may view
offering terms and this prospectus online and, depending upon
the underwriter, prospective investors may be allowed to place
orders online or through their financial advisor. The
underwriters may agree with us to allocate a specific number of
shares for sale to online brokerage account holders. Any such
allocation for online distributions will be made by the
underwriters on the same basis as other allocations.
115
Other than this prospectus in electronic format, the information
on any underwriters website and any information contained
in any other website maintained by the underwriters is not part
of this prospectus or the registration statement of which the
prospectus forms a part, has not been approved or endorsed by us
or the underwriters in its capacity as underwriter and should
not be relied upon by investors.
At our request, certain of the underwriters have reserved up to
5% of the shares of common stock being sold in this offering for
sale under a directed share program to our employees, directors,
officers, stockholders and other persons who are associated with
us and certain of their friends and family members. The
purchasers of these shares will not be subject to a lock-up
except to the extent these purchasers are subject to a lock-up
agreement with the underwriters as described above. The number
of shares available for sale to the general public in this
offering will be reduced to the extent that these reserved
shares are purchased by these purchasers. Any reserved shares
not purchased by these purchasers will be offered by certain of
the underwriters to the general public on the same basis as the
other shares in this offering. All sales of shares under the
directed share program will be made at the initial public
offering price set forth on the cover page of this prospectus.
Certain of the underwriters and their affiliates have performed
certain investment banking, advisory and commercial banking
services for us from time to time for which they have received
customary fees and expenses. From time to time in the ordinary
course of their respective businesses, some of the underwriters
and their affiliates may in the future engage in commercial
banking and/or investment banking transactions with our
affiliates and us. We paid Lazard Frères & Co. LLC
$392,000 in December 2005 for investment banking and advisory
services performed from October 2005 to December 2005.
Lazard Frères & Co. LLC referred this
transaction to Lazard Capital Markets LLC and will receive
a referral fee from Lazard Capital Markets LLC in
connection therewith.
In September 2004, we entered into an engagement letter with
Legg Mason Wood Walker, Inc., pursuant to which we agreed to
engage Legg Mason Wood Walker, Inc. as an exclusive placement
agent or underwriter with respect to future securities
offerings. We and Legg Mason Wood Walker, Inc. subsequently
agreed to amend the engagement letter to require that we engage
Legg Mason Wood Walker, Inc. only as a non-exclusive agent with
respect to future securities offerings, and in connection with
the amendment, we agreed to pay Legg Mason Wood Walker, Inc.
$526,213 in cash and to issue to Legg Mason Wood Walker, Inc. a
warrant to purchase 47,058 shares of Series E
preferred stock at a price per share of $10.63. In December
2005, Stifel, Nicolaus & Company, Incorporated acquired
Legg Mason Wood Walker, Inc.s investment banking business.
In May 2006, we entered into a settlement agreement with Stifel,
Nicolaus & Company, Incorporated. The parties agreed to
settle their respective claims and disputes arising from the
engagement letter, as amended. Pursuant to this settlement
agreement, we agreed to pay Stifel, Nicolaus & Company,
Incorporated $500,000 in cash and agreed to the terms of their
participation as an underwriter in this offering.
Pursuant to the terms of selected dealer agreements entered into
with National Securities Corporation in December 2005 and
February 2006, we engaged National Securities Corporation to act
as our placement agent with respect to private placements of our
Series E preferred stock. We paid cash commissions in an
aggregate amount of $3,549,100 and issued warrants to purchase
an aggregate of 324,621 shares of Series E preferred stock
at an exercise price of $10.63 per share to National
Securities Corporation in consideration for its services as
placement agent. In addition, we reimbursed National Securities
Corporation for certain legal and other expenses incurred in
connection with the private placements.
116
LEGAL MATTERS
Legal matters with respect to the validity of the common stock
offered hereby will be passed upon for us by Heller Ehrman LLP,
San Diego, California. Wilson Sonsini Goodrich &
Rosati, P.C., San Diego, California is counsel for the
underwriters in connection with this offering.
EXPERTS
The consolidated financial statements of Artes Medical, Inc. at
December 31, 2004 and 2005, and for each of the three years
in the period ended December 31, 2005, appearing in this
Prospectus and Registration Statement have been audited by
Ernst & Young LLP, independent registered public
accounting firm, as set forth in their report thereon appearing
elsewhere herein, and are included in reliance upon such report
given on the authority of such firm as experts in accounting and
auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on
Form S-1 under the
Securities Act of 1933 with respect to the common stock we are
offering. This prospectus, which constitutes a part of the
registration statement, does not contain all of the information
in the registration statement or the exhibits of the
registration statement. For further information with respect to
us and our common stock, we refer you to the registration
statement and to the exhibits to the registration statement.
Statements contained in this prospectus as to the contents of
any contract, agreement or other document to which we make
reference are not necessarily complete. In each instance, we
refer you to the copy of such contract, agreement or other
document filed as an exhibit to the registration statement, each
such statement being qualified in all respects by the more
complete description of the matter involved.
You may read and copy the registration statement of which this
prospectus is a part at the SECs Public Reference Room,
which is located at 100 F Street, N.E., Washington, D.C.
20549. You can request copies of the registration statement by
writing to the SEC and paying a fee for the copying cost. Please
call the SEC at
1-800-SEC-0330 for more
information about the operation of the SECs Public
Reference Room. In addition, the SEC maintains an Internet web
site, which is located at www.sec.gov, which contains reports,
proxy and information statements and other information regarding
issuers that file electronically with the SEC. You may access
the registration statement of which this prospectus is a part at
the SECs Internet web site. Upon completion of this
offering, we will be subject to the information reporting
requirements of the Securities Exchange Act of 1934, and we will
file reports, proxy statements and other information with the
SEC.
We maintain an Internet website at
http://www.artesmedical.com. We have not incorporated by
reference into this prospectus the information on our web site,
and you should not consider it to be a part of this prospectus.
This prospectus includes statistical data obtained from industry
publications. These industry publications generally indicate
that the authors of these publications have obtained information
from sources believed to be reliable but do not guarantee the
accuracy and completeness of their information. While we believe
these industry publications to be reliable, we have not
independently verified their data.
117
Artes Medical, Inc.
(a development stage company)
Index to Consolidated Financial Statements
F-1
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Artes Medical, Inc.
We have audited the accompanying consolidated balance sheets of
Artes Medical, Inc. (a development stage company) as of
December 31, 2004 and 2005, and the related consolidated
statements of operations, stockholders equity
(deficit) and cash flows for each of the three years in the
period ended December 31, 2005. These financial statements
are the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. We were not engaged to perform an
audit of the Companys internal control over financial
reporting. Our audits included consideration of internal control
over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of
the Companys internal control over financial reporting.
Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by
management, and evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the consolidated
financial position of Artes Medical, Inc. (a development stage
company) at December 31, 2004 and 2005, and the
consolidated results of its operations and its cash flows for
each of the three years in the period ended December 31,
2005, in conformity with U.S. generally accepted accounting
principles.
San Diego, California
May 4, 2006,
except for the third through the nineteenth paragraphs of
Note 11, as to which the date is
November 27, 2006
F-2
Artes Medical, Inc.
(a development stage company)
Consolidated Balance Sheets
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma | |
|
|
December 31, | |
|
|
|
Stockholders | |
|
|
| |
|
September 30, | |
|
Equity at | |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
September 30, 2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(unaudited) | |
|
(unaudited) | |
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
2,269 |
|
|
$ |
6,930 |
|
|
$ |
12,789 |
|
|
|
|
|
|
Prepaid expenses
|
|
|
130 |
|
|
|
204 |
|
|
|
274 |
|
|
|
|
|
|
Inventory, net
|
|
|
250 |
|
|
|
692 |
|
|
|
4,019 |
|
|
|
|
|
|
Other assets
|
|
|
299 |
|
|
|
374 |
|
|
|
78 |
|
|
|
|
|
|
Deferred financing costs
|
|
|
|
|
|
|
1,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
2,948 |
|
|
|
9,211 |
|
|
|
17,160 |
|
|
|
|
|
Property and equipment, net
|
|
|
921 |
|
|
|
4,926 |
|
|
|
5,419 |
|
|
|
|
|
Intellectual property, net
|
|
|
5,964 |
|
|
|
4,770 |
|
|
|
3,876 |
|
|
|
|
|
Deposits
|
|
|
222 |
|
|
|
233 |
|
|
|
239 |
|
|
|
|
|
Other assets
|
|
|
241 |
|
|
|
1,180 |
|
|
|
3,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
10,296 |
|
|
$ |
20,320 |
|
|
$ |
29,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders equity (deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
3,553 |
|
|
$ |
3,317 |
|
|
$ |
1,231 |
|
|
|
|
|
|
Accrued compensation and benefits
|
|
|
154 |
|
|
|
1,499 |
|
|
|
2,304 |
|
|
|
|
|
|
Accrued liabilities
|
|
|
740 |
|
|
|
1,585 |
|
|
|
1,108 |
|
|
|
|
|
|
Income taxes payable
|
|
|
43 |
|
|
|
70 |
|
|
|
70 |
|
|
|
|
|
|
Mediplant acquisition liability
|
|
|
2,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes payable (net of discount of $860 at
December 31, 2005)
|
|
|
|
|
|
|
5,665 |
|
|
|
|
|
|
|
|
|
|
Capital lease obligations, current portion
|
|
|
|
|
|
|
49 |
|
|
|
44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
6,740 |
|
|
|
12,185 |
|
|
|
4,757 |
|
|
|
|
|
Convertible notes payable (net of discount of $1,780 at
December 31, 2004)
|
|
|
5,323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligations, less current portion
|
|
|
|
|
|
|
66 |
|
|
|
31 |
|
|
|
|
|
Deferred rent
|
|
|
486 |
|
|
|
686 |
|
|
|
718 |
|
|
|
|
|
Deferred tax liability
|
|
|
2,341 |
|
|
|
1,846 |
|
|
|
1,704 |
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity (deficit):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.001 par
value, 2,050,839 shares authorized, issued and outstanding
at December 31, 2004 and 2005 and September 30, 2006
(unaudited); liquidation preference of $3,076 at
December 31, 2005 and September 30, 2006 (unaudited);
no shares issued or outstanding pro forma (unaudited)
|
|
|
2 |
|
|
|
2 |
|
|
|
2 |
|
|
$ |
|
|
|
Series B convertible preferred stock, $0.001 par
value, 679,239 shares authorized, issued and outstanding at
December 31, 2004 and 2005 and September 30, 2006
(unaudited); liquidation preference of $2,262 at
December 31, 2005 and September 30, 2006 (unaudited);
no shares issued or outstanding pro forma (unaudited)
|
|
|
1 |
|
|
|
1 |
|
|
|
1 |
|
|
|
|
|
|
Series C-1 convertible preferred stock, $0.001 par
value, 7,052,741 shares authorized, 4,437,741 issued and
outstanding at December 31, 2004 and 2005 and 4,487,741
issued and outstanding at September 30, 2006 (unaudited);
liquidation preference of $12,204 at December 31, 2005 and
$12,341 at September 30, 2006 (unaudited); no shares issued
or outstanding pro forma (unaudited)
|
|
|
4 |
|
|
|
4 |
|
|
|
4 |
|
|
|
|
|
|
Series D convertible preferred stock, $0.001 par
value, 11,500,000 shares authorized, none and 10,019,857
issued and outstanding at December 31, 2004 and 2005,
respectively and 10,019,857 issued and outstanding at
September 30, 2006 (unaudited); liquidation preference of
$20,040 at December 31, 2005 and September 30, 2006
(unaudited); no shares issued or outstanding pro forma
(unaudited)
|
|
|
|
|
|
|
10 |
|
|
|
10 |
|
|
|
|
|
|
Series E convertible preferred stock, $0.001 par
value, 10,000,000 shares authorized, none and 3,463,615
issued and outstanding at December 31, 2004 and 2005,
respectively and 25,000,000 authorized, 20,654,221 issued
and outstanding at September 30, 2006 (unaudited);
liquidation preference of $8,659 at December 31, 2005 and
$51,636 at September 30, 2006 (unaudited); no shares issued
or outstanding pro forma (unaudited)
|
|
|
|
|
|
|
3 |
|
|
|
21 |
|
|
|
|
|
|
Convertible preferred stock subscribed
|
|
|
3,543 |
|
|
|
6,900 |
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value 150,000,000 shares
authorized at December 31, 2004 and 2005; 1,138,644 and
1,229,553 shares issued and outstanding at
December 31, 2004 and 2005 and 1,390,930 issued and
outstanding at September 30, 2006 (unaudited),
respectively; 200,000,000 shares authorized pro forma;
10,758,441 shares issued and outstanding pro forma
(unaudited)
|
|
|
5 |
|
|
|
5 |
|
|
|
1 |
|
|
|
11 |
|
|
Common stock issuable
|
|
|
|
|
|
|
735 |
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital
|
|
|
23,318 |
|
|
|
53,635 |
|
|
|
94,144 |
|
|
|
94,172 |
|
|
Deferred stock-based compensation
|
|
|
(631 |
) |
|
|
(2,679 |
) |
|
|
|
|
|
|
|
|
|
Deficit accumulated during the development stage
|
|
|
(30,836 |
) |
|
|
(53,079 |
) |
|
|
(71,648 |
) |
|
|
(71,648 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity (deficit)
|
|
|
(4,594 |
) |
|
|
5,537 |
|
|
|
22,535 |
|
|
$ |
22,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity (deficit)
|
|
$ |
10,296 |
|
|
$ |
20,320 |
|
|
$ |
29,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-3
Artes Medical, Inc.
(a development stage company)
Consolidated Statements of Operations
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
|
|
|
August 24, 1999 | |
|
|
|
|
Nine Months | |
|
(Inception) | |
|
|
Years Ended December 31, | |
|
Ended September 30, | |
|
through | |
|
|
| |
|
| |
|
September 30, | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
(unaudited) | |
|
(unaudited) | |
|
(unaudited) | |
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$ |
974 |
|
|
$ |
3,634 |
|
|
$ |
10,189 |
|
|
$ |
6,754 |
|
|
$ |
5,698 |
|
|
$ |
26,603 |
|
|
Selling, general and administrative
|
|
|
2,976 |
|
|
|
5,155 |
|
|
|
10,137 |
|
|
|
6,723 |
|
|
|
11,463 |
|
|
|
35,062 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,950 |
) |
|
|
(8,789 |
) |
|
|
(20,326 |
) |
|
|
(13,477 |
) |
|
|
(17,161 |
) |
|
|
(61,665 |
) |
Interest income
|
|
|
1 |
|
|
|
|
|
|
|
52 |
|
|
|
27 |
|
|
|
503 |
|
|
|
669 |
|
Interest expense
|
|
|
(2,171 |
) |
|
|
(4,028 |
) |
|
|
(4,468 |
) |
|
|
(3,545 |
) |
|
|
(2,410 |
) |
|
|
(14,181 |
) |
Other income (expense), net
|
|
|
|
|
|
|
(22 |
) |
|
|
2,041 |
|
|
|
(11 |
) |
|
|
351 |
|
|
|
2,469 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before benefit for income taxes
|
|
|
(6,120 |
) |
|
|
(12,839 |
) |
|
|
(22,701 |
) |
|
|
(17,006 |
) |
|
|
(18,717 |
) |
|
|
(72,708 |
) |
Benefit for income taxes
|
|
|
|
|
|
|
454 |
|
|
|
458 |
|
|
|
141 |
|
|
|
148 |
|
|
|
1,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(6,120 |
) |
|
$ |
(12,385 |
) |
|
$ |
(22,243 |
) |
|
$ |
(16,865 |
) |
|
$ |
(18,569 |
) |
|
$ |
(71,648 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$ |
(5.76 |
) |
|
$ |
(11.20 |
) |
|
$ |
(18.76 |
) |
|
$ |
(14.38 |
) |
|
$ |
(13.81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares - basic and diluted
|
|
|
1,062,825 |
|
|
|
1,106,188 |
|
|
|
1,185,387 |
|
|
|
1,172,419 |
|
|
|
1,344,503 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss per common share (unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
|
|
|
|
|
|
|
$ |
(5.15 |
) |
|
|
|
|
|
$ |
(1.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares - pro forma basic and diluted (unaudited)
|
|
|
|
|
|
|
|
|
|
|
4,319,411 |
|
|
|
|
|
|
|
9,885,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-4
Artes Medical, Inc.
(a development stage company)
Consolidated Statements of Stockholders Equity (Deficit)
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
Accumulated | |
|
Total | |
|
|
Convertible | |
|
|
|
Common |
|
Convertible | |
|
Additional | |
|
Other | |
|
Deferred |
|
During the | |
|
Stockholders | |
|
|
Preferred Stock | |
|
Common Stock | |
|
Stock |
|
Preferred Stock | |
|
Paid-In | |
|
Comprehensive | |
|
Stock-Based |
|
Development | |
|
Equity | |
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Issuable |
|
Subscribed | |
|
Capital | |
|
Loss | |
|
Compensation |
|
Stage | |
|
(Deficit) | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
| |
|
| |
|
| |
|
|
|
| |
|
| |
|
Issuance of common stock for cash at $0.09 per share
|
|
|
|
|
|
$ |
|
|
|
|
735,294 |
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
84 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
85 |
|
|
Issuance of common stock for services
|
|
|
|
|
|
|
|
|
|
|
173,529 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
176 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
176 |
|
|
Issuance of Series A preferred stock for cash at
$1.50 per share
|
|
|
112,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
168 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
168 |
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(896 |
) |
|
|
(896 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 1999
|
|
|
112,266 |
|
|
|
|
|
|
|
908,823 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
428 |
|
|
|
|
|
|
|
|
|
|
|
(896 |
) |
|
|
(467 |
) |
|
Issuance of Series A preferred stock for cash at
$1.50 per share, net of issuance costs
|
|
|
1,912,902 |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,813 |
|
|
Issuance of Series A preferred stock for services
|
|
|
25,671 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114 |
|
|
Issuance of Series B preferred stock for cash at
$3.33 per share
|
|
|
489,187 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,418 |
|
|
Issuance of Series B preferred stock for services
|
|
|
1,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
|
|
Issuance of common stock for cash, in March, May, and September
|
|
|
|
|
|
|
|
|
|
|
151,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
508 |
|
|
Issuance of stock options to consultants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48 |
|
|
Unrealized loss on available-for-sale investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36 |
) |
|
|
|
|
|
|
|
|
|
|
(36 |
) |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,147 |
) |
|
|
(2,147 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,183 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2000
|
|
|
2,541,167 |
|
|
|
3 |
|
|
|
1,060,117 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
5,330 |
|
|
|
(36 |
) |
|
|
|
|
|
|
(3,043 |
) |
|
|
2,255 |
|
|
Series C preferred stock subscriptions at $7.00 per
share for cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
682 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
682 |
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
Issuance of Series B preferred stock in July for cash at
$3.33 per share, net of issuance costs
|
|
|
188,911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
620 |
|
|
Reclassification adjustment for losses realized in net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
36 |
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,942 |
) |
|
|
(4,942 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,906 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2001
|
|
|
2,730,078 |
|
|
|
3 |
|
|
|
1,060,117 |
|
|
|
1 |
|
|
|
|
|
|
|
682 |
|
|
|
5,951 |
|
|
|
|
|
|
|
|
|
|
|
(7,985 |
) |
|
|
(1,348 |
) |
|
Issuance of subscribed Series C preferred stock in March
|
|
|
88,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(622 |
) |
|
|
622 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Series C preferred stock, in March, for cash at
$7.00 per share, net of issuance costs
|
|
|
21,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99 |
|
|
Refund due to cancellation of Series C preferred stock
subscribed
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(60 |
) |
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
Issuance of warrants in connection with convertible notes from
May to November
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,489 |
|
|
Issuance of Series C preferred stock for services in March
|
|
|
2,730 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19 |
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,346 |
) |
|
|
(4,346 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
2,842,951 |
|
|
|
3 |
|
|
|
1,060,117 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
8,186 |
|
|
|
|
|
|
|
|
|
|
|
(12,331 |
) |
|
|
(4,141 |
) |
|
Issuance of common stock upon exercise of stock options in
November
|
|
|
|
|
|
|
|
|
|
|
17,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
|
|
Issuance of Series C-1 preferred stock for services in July
|
|
|
25,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
69 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
69 |
|
|
Issuance of warrants in connection with convertible notes from
January through March
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,126 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,126 |
|
|
Issuance of Series C-1 preferred stock for cash, in July,
at $2.75 per share, net of issuance costs
|
|
|
637,980 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,596 |
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
159 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
159 |
|
|
Issuance of warrant in June in connection with patent acquisition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34 |
|
|
Conversion of Series C preferred stock to Series C-1
preferred stock in July
|
|
|
174,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of principal and interest on promissory notes to
Series C-1 preferred stock in July
|
|
|
3,486,934 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,642 |
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,120 |
) |
|
|
(6,120 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
7,167,819 |
|
|
|
7 |
|
|
|
1,077,764 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
15,815 |
|
|
|
|
|
|
|
|
|
|
|
(18,451 |
) |
|
|
(2,628 |
) |
F-5
Artes Medical, Inc.
(a development stage company)
Consolidated Statements of Stockholders Equity (Deficit)
(continued)
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
Accumulated | |
|
Total | |
|
|
Convertible | |
|
|
|
Common | |
|
Convertible | |
|
Additional | |
|
Other |
|
Deferred | |
|
During the | |
|
Stockholders | |
|
|
Preferred Stock | |
|
Common Stock | |
|
Stock | |
|
Preferred Stock | |
|
Paid-In | |
|
Comprehensive |
|
Stock-Based | |
|
Development | |
|
Equity | |
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Issuable | |
|
Subscribed | |
|
Capital | |
|
Loss |
|
Compensation | |
|
Stage | |
|
(Deficit) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
| |
|
| |
|
| |
|
Issuance of common stock upon exercise of stock options, in
April and October
|
|
|
|
|
|
|
|
|
|
|
14,117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29 |
|
|
Issuance of common stock in connection with intellectual
property acquisition, in March and September
|
|
|
|
|
|
|
|
|
|
|
42,352 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
270 |
|
|
Issuance of common stock for services rendered in September
|
|
|
|
|
|
|
|
|
|
|
4,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37 |
|
|
Series D preferred stock subscriptions at $2.00 per
share for cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,543 |
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,096 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,096 |
|
|
Deferred stock compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
740 |
|
|
|
|
|
|
|
(740 |
) |
|
|
|
|
|
|
|
|
|
Issuance of warrants in connection with convertible notes from
January though September
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,335 |
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
109 |
|
|
|
|
|
|
|
109 |
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,385 |
) |
|
|
(12,385 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
7,167,819 |
|
|
|
7 |
|
|
|
1,138,644 |
|
|
|
1 |
|
|
|
|
|
|
|
3,543 |
|
|
|
23,322 |
|
|
|
|
|
|
|
(631 |
) |
|
|
(30,836 |
) |
|
|
(4,594 |
) |
|
Issuance of common stock upon exercise of stock options in March
|
|
|
|
|
|
|
|
|
|
|
5,882 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25 |
|
|
Issuance of common stock upon exercise of warrants in May
through October
|
|
|
|
|
|
|
|
|
|
|
23,731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
120 |
|
|
Issuance of common stock for services rendered in April through
December
|
|
|
|
|
|
|
|
|
|
|
51,528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
386 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
386 |
|
|
Issuance of common stock in connection with settlement agreement
in October
|
|
|
|
|
|
|
|
|
|
|
9,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102 |
|
|
Common stock issuable in exchange for guarantee on convertible
debt in December
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
735 |
|
|
Issuance of Series D preferred stock in exchange for
convertible notes and accrued interest, and cash, in May, at
$2.00 per share, net of issuance costs
|
|
|
9,754,761 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,543 |
) |
|
|
14,245 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,712 |
|
|
Issuance of Series D preferred stock at $2.00 in exchange
for services in May
|
|
|
265,096 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
367 |
|
|
Issuance of warrants in connection with Series D
convertible preferred stock in May
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
809 |
|
|
Issuance of warrants in connection with convertible note payable
in January through September
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,007 |
|
|
Issuance of warrants in connection with amendment of convertible
notes in December
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
276 |
|
|
Issuance of Series E preferred stock for cash, in December
2005, at $2.50 per share, net of issuance costs
|
|
|
3,089,615 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,706 |
|
|
Series E preferred stock subscriptions at $2.50 per
share for cash in December
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,900 |
|
|
Issuance of Series E preferred stock at $2.50 per
share in exchange for termination agreement in December
|
|
|
124,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
310 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
310 |
|
|
Issuance of Series E preferred stock at $2.50 per
share in exchange for amendment of convertible note payable in
December
|
|
|
250,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
625 |
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
959 |
|
|
Deferred stock compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,383 |
|
|
|
|
|
|
|
(2,383 |
) |
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
335 |
|
|
|
|
|
|
|
335 |
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(22,243 |
) |
|
|
(22,243 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
20,651,291 |
|
|
|
20 |
|
|
|
1,229,553 |
|
|
|
1 |
|
|
|
735 |
|
|
|
6,900 |
|
|
|
53,639 |
|
|
|
|
|
|
|
(2,679 |
) |
|
|
(53,079 |
) |
|
|
5,537 |
|
|
Issuance of common stock upon exercise of warrants and stock
options in March through September (unaudited)
|
|
|
|
|
|
|
|
|
|
|
78,036 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
381 |
|
|
Issuance of common stock for services in January through May
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
8,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89 |
|
|
Issuance of common stock in connection with intellectual
property in January (unaudited)
|
|
|
|
|
|
|
|
|
|
|
4,705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49 |
|
|
Issuance of Series E convertible preferred stock at $2.50
per share for cash, in January, net of issuance costs (unaudited)
|
|
|
3,994,000 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,750 |
) |
|
|
9,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,621 |
|
|
Issuance of Series E convertible preferred stock at $2.50
per share for cash, in February, net of issuance costs
(unaudited)
|
|
|
5,484,200 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(150 |
) |
|
|
12,444 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,300 |
|
|
Issuance of Series E convertible preferred stock at $2.50
per share for cash, in March, net of issuance costs (unaudited)
|
|
|
7,712,406 |
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,896 |
|
|
Issuance of Series C-1 convertible preferred stock upon
exercise of warrants for cash in May (unaudited)
|
|
|
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50 |
|
|
Issuance of common stock in connection with guarantee on
convertible debt (unaudited)
|
|
|
|
|
|
|
|
|
|
|
70,588 |
|
|
|
|
|
|
|
(735 |
) |
|
|
|
|
|
|
735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,805 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,805 |
|
|
Deferred stock compensation (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,679 |
) |
|
|
|
|
|
|
2,679 |
|
|
|
|
|
|
|
|
|
|
Warrant modification expense (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,376 |
|
|
Net loss and comprehensive loss (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,569 |
) |
|
|
(18,569 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2006 (unaudited)
|
|
|
37,891,897 |
|
|
$ |
38 |
|
|
|
1,390,930 |
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
94,144 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(71,648 |
) |
|
$ |
22,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-6
Artes Medical, Inc.
(a development stage company)
Consolidated Statements of Cash Flows
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months | |
|
Period from | |
|
|
|
|
Ended | |
|
August 24, 1999 | |
|
|
Years Ended December 31, | |
|
September 30, | |
|
(Inception) through | |
|
|
| |
|
| |
|
September 30, | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
(unaudited) | |
|
(unaudited) | |
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(6,120 |
) |
|
$ |
(12,385 |
) |
|
$ |
(22,243 |
) |
|
$ |
(16,865 |
) |
|
$ |
(18,569 |
) |
|
$ |
(71,648 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
35 |
|
|
|
1,148 |
|
|
|
1,742 |
|
|
|
1,210 |
|
|
|
1,786 |
|
|
|
4,863 |
|
|
Provision for obsolete inventory
|
|
|
|
|
|
|
117 |
|
|
|
120 |
|
|
|
|
|
|
|
200 |
|
|
|
437 |
|
|
Benefit for income taxes
|
|
|
|
|
|
|
(454 |
) |
|
|
(458 |
) |
|
|
(142 |
) |
|
|
(142 |
) |
|
|
(1,054 |
) |
|
Noncash interest expense associated with issuance of warrants
and convertible notes
|
|
|
1,870 |
|
|
|
4,002 |
|
|
|
4,308 |
|
|
|
3,412 |
|
|
|
2,348 |
|
|
|
13,273 |
|
|
Warrant modification expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
899 |
|
|
|
899 |
|
|
Stock-based compensation
|
|
|
159 |
|
|
|
1,133 |
|
|
|
1,294 |
|
|
|
502 |
|
|
|
1,805 |
|
|
|
4,445 |
|
|
Issuance of stock for services
|
|
|
69 |
|
|
|
38 |
|
|
|
558 |
|
|
|
419 |
|
|
|
90 |
|
|
|
1,066 |
|
|
Issuance of stock for settlement and termination agreements
|
|
|
|
|
|
|
|
|
|
|
412 |
|
|
|
|
|
|
|
|
|
|
|
412 |
|
|
Issuance of common stock for intellectual property
|
|
|
|
|
|
|
270 |
|
|
|
|
|
|
|
|
|
|
|
49 |
|
|
|
319 |
|
|
Loss on disposal of fixed assets
|
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
|
|
|
|
32 |
|
|
|
57 |
|
|
Deferred rent
|
|
|
(1 |
) |
|
|
474 |
|
|
|
200 |
|
|
|
147 |
|
|
|
32 |
|
|
|
718 |
|
|
Deferred taxes
|
|
|
|
|
|
|
(43 |
) |
|
|
(27 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
|
|
|
|
|
(160 |
) |
|
|
(562 |
) |
|
|
(122 |
) |
|
|
(3,527 |
) |
|
|
(4,249 |
) |
|
|
Prepaid expenses and other assets
|
|
|
|
|
|
|
(776 |
) |
|
|
(208 |
) |
|
|
(81 |
) |
|
|
226 |
|
|
|
(757 |
) |
|
|
Accounts payable
|
|
|
709 |
|
|
|
1,281 |
|
|
|
(398 |
) |
|
|
945 |
|
|
|
(2,085 |
) |
|
|
1,384 |
|
|
|
Accrued compensation
|
|
|
188 |
|
|
|
(20 |
) |
|
|
1,346 |
|
|
|
810 |
|
|
|
804 |
|
|
|
2,334 |
|
|
|
Accrued expenses
|
|
|
263 |
|
|
|
471 |
|
|
|
834 |
|
|
|
(53 |
) |
|
|
(478 |
) |
|
|
1,287 |
|
|
|
Income taxes payable
|
|
|
|
|
|
|
43 |
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(2,828 |
) |
|
|
(4,836 |
) |
|
|
(13,055 |
) |
|
|
(9,818 |
) |
|
|
(16,530 |
) |
|
|
(46,214 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,028 |
) |
Sale of short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,028 |
|
Acquisition of intellectual property, net of cash acquired
|
|
|
|
|
|
|
(1,730 |
) |
|
|
(2,250 |
) |
|
|
(1,500 |
) |
|
|
|
|
|
|
(3,980 |
) |
Purchases of property and equipment
|
|
|
|
|
|
|
(816 |
) |
|
|
(4,554 |
) |
|
|
(3,948 |
) |
|
|
(1,415 |
) |
|
|
(7,046 |
) |
Deposits and other assets
|
|
|
(250 |
) |
|
|
|
|
|
|
(950 |
) |
|
|
(110 |
) |
|
|
(1,878 |
) |
|
|
(3,133 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(250 |
) |
|
|
(2,546 |
) |
|
|
(7,754 |
) |
|
|
(5,558 |
) |
|
|
(3,293 |
) |
|
|
(14,159 |
) |
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of convertible notes payable
|
|
|
1,455 |
|
|
|
6,093 |
|
|
|
6,970 |
|
|
|
6,970 |
|
|
|
|
|
|
|
17,519 |
|
Proceeds from capital lease obligations
|
|
|
|
|
|
|
|
|
|
|
157 |
|
|
|
157 |
|
|
|
|
|
|
|
157 |
|
Payments on capital lease obligations
|
|
|
|
|
|
|
|
|
|
|
(41 |
) |
|
|
(28 |
) |
|
|
(40 |
) |
|
|
(81 |
) |
Proceeds from issuance of note payable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
416 |
|
Payments on note payable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(416 |
) |
Refund on canceled subscribed Series C preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(60 |
) |
Payments on convertible note payable
|
|
|
|
|
|
|
(50 |
) |
|
|
|
|
|
|
|
|
|
|
(6,525 |
) |
|
|
(6,575 |
) |
Proceeds from subscribed preferred stock
|
|
|
|
|
|
|
3,543 |
|
|
|
6,900 |
|
|
|
3,446 |
|
|
|
|
|
|
|
11,125 |
|
Proceeds from issuance of preferred stock, net
|
|
|
1,596 |
|
|
|
|
|
|
|
11,456 |
|
|
|
4,528 |
|
|
|
31,816 |
|
|
|
49,986 |
|
Proceeds from issuance of common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
595 |
|
Proceeds from exercise of stock options and warrants
|
|
|
8 |
|
|
|
29 |
|
|
|
28 |
|
|
|
26 |
|
|
|
431 |
|
|
|
496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
3,059 |
|
|
|
9,615 |
|
|
|
25,470 |
|
|
|
15,099 |
|
|
|
25,682 |
|
|
|
73,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(19 |
) |
|
|
2,233 |
|
|
|
4,661 |
|
|
|
(277 |
) |
|
|
5,859 |
|
|
|
12,789 |
|
Cash and cash equivalents at beginning of period
|
|
|
55 |
|
|
|
36 |
|
|
|
2,269 |
|
|
|
2,269 |
|
|
|
6,930 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$ |
36 |
|
|
$ |
2,269 |
|
|
$ |
6,930 |
|
|
$ |
1,992 |
|
|
$ |
12,789 |
|
|
$ |
12,789 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncash financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of subscribed preferred stock
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,543 |
|
|
$ |
|
|
|
$ |
6,900 |
|
|
$ |
11,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants and common stock in connection with
intellectual property acquisition
|
|
$ |
34 |
|
|
$ |
270 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
49 |
|
|
$ |
353 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible notes and interest into convertible
preferred stock
|
|
$ |
4,640 |
|
|
$ |
|
|
|
$ |
8,246 |
|
|
$ |
1,008 |
|
|
$ |
|
|
|
$ |
12,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of convertible notes payable as commission for financing
|
|
$ |
|
|
|
$ |
141 |
|
|
$ |
203 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
344 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of payables to convertible notes payable
|
|
$ |
|
|
|
$ |
234 |
|
|
$ |
95 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes
|
|
$ |
1 |
|
|
$ |
2 |
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
6 |
|
|
$ |
13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$ |
|
|
|
$ |
26 |
|
|
$ |
160 |
|
|
$ |
|
|
|
$ |
60 |
|
|
$ |
334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-7
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements
|
|
1. |
Organization and Summary of Significant Accounting
Policies |
Organization and Business
Artes Medical, Inc., (the Company), formerly known
as Artes Medical USA, Inc., was incorporated in Delaware on
August 24, 1999, and is focused on the development,
manufacture and commercialization of a new category of
injectable aesthetic products for the dermatology and plastic
surgery markets. The Companys initial product, ArteFill,
is a non-resorbable aesthetic injectable implant for the
correction of facial wrinkles known as smile lines, or
nasolabial folds.
The Company is a development stage company, and since inception
has been engaged in organizational activities, including
research and development, recruiting personnel, establishing
office and manufacturing facilities, preparing for
ArteFills regulatory market approval and the related
commercial scale-up of
ArteFill manufacturing, preparing for ArteFill product marketing
and distribution activities, and obtaining financing. Since
inception, and through December 31, 2005, the Company has
an accumulated deficit of $53.1 million.
Principles of Consolidation
The consolidated financial statements include the accounts of
the Company and Artes Medical Germany GmbH (formerly Mediplant
GmbH Biomaterials & Medical Devices) since its
acquisition effective January 1, 2004. All intercompany
accounts have been eliminated in consolidation.
Unaudited Pro Forma Stockholders Equity
The Companys board of directors has authorized the filing
of a registration statement with the Securities and Exchange
Commission to register shares of its common stock in an initial
public offering. Upon the closing of the initial public
offering, all of the shares of convertible preferred stock,
including common stock issuable under anti-dilution provisions,
will be converted into 9,367,511 shares of common stock.
The unaudited pro forma stockholders equity reflects the
conversion of all outstanding convertible preferred stock into
common stock as if such conversion had occurred at
September 30, 2006.
Use of Estimates
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that
affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ
from those estimates.
Interim Financial Information
The consolidated financial statements as of September 30,
2006 and for the nine months ended September 30, 2005 and
2006 and for the period from August 24, 1999 (inception) through
September 30, 2006 are unaudited. The unaudited
consolidated financial statements have been prepared on the same
basis as the audited consolidated financial statements, and, in
the opinion of management, include all adjustments, consisting
of only normal recurring accruals, necessary to state fairly the
financial information set forth therein, in accordance with
accounting principles generally accepted in the United States.
The results of operations for the interim period ended
September 30, 2006 are not necessarily indicative of the
results which may be reported for any other interim period or
for the year ending December 31, 2006.
F-8
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
1. |
Organization and Summary of Significant Accounting Policies
(continued) |
Cash and Cash Equivalents
The Company considers all highly liquid investments with an
original maturity of less than three months when purchased to be
cash equivalents.
Reclassifications
Certain prior year amounts have been reclassified to conform to
the current year presentation.
Fair Value of Financial Instruments
The carrying amount of cash, accounts payable, and accrued
liabilities are considered to be representative of their
respective fair values because of the short-term nature of those
instruments. The Company believes the carrying amount of the
notes payable approximate their respective fair values.
Concentration of Credit Risk
Financial instruments, which potentially subject the Company to
significant concentration of credit risk, consist primarily of
cash and cash equivalents. The Company maintains deposits in
federally insured financial institutions in excess of federally
insured limits. Management believes that the Company is not
exposed to significant credit risk due to the financial position
of the depository institutions in which those deposits are held.
Property and Equipment
Property and equipment are stated at cost and depreciated over
the estimated useful lives of the assets (three to seven years)
using the straight-line method. Leasehold improvements are
amortized over the lesser of the term of the related lease or
the useful life of the asset.
Impairment of Long-Lived Assets
In accordance with Statement of Financial Accounting Standards
(SFAS) No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, the Company
will record impairment losses on long-lived assets used in
operations when events and circumstances indicate that assets
might be impaired and the undiscounted cash flows estimated to
be generated by those assets are less than the carrying amount
of those assets. While the Companys current and historical
operating losses and cash flows are indicators of impairment,
the Company believes the future cash flows to be received
support the carrying value of its long-lived assets and,
accordingly, the Company has not recognized any impairment
losses through June 30, 2006.
Deferred Rent
Rent expense is recorded on a straight-line basis over the term
of the lease. The difference between rent expense and amounts
paid under the lease agreements is recorded as deferred rent in
the accompanying consolidated balance sheets. Landlord
construction allowances and other such lease incentives are
recorded as deferred rent and are amortized on a straight-line
basis as a reduction to rent expense.
Patent Costs
Costs related to filing and pursuing patent applications are
expensed as general and administrative expenses as incurred
since recoverability of such expenditures is uncertain.
F-9
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
1. |
Organization and Summary of Significant Accounting Policies
(continued) |
Research and Development Expenses
Research and development costs are expensed as incurred and
costs consist primarily of costs to further the Companys
research and development activities and include compensation and
other expenses for research and development personnel, costs
associated with clinical trials, non-clinical activities,
process development activities, regulatory activities, supplies
and development materials, costs for consultants,
research-related overhead expenses, amortization of purchased
technology, and depreciation.
Income Taxes
The Company uses the liability method of accounting for income
taxes as required by SFAS No. 109, Accounting for
Income Taxes. Under this method, deferred tax assets and
liabilities are determined based on the difference between the
financial reporting and the tax reporting basis of assets and
liabilities and are measured using the enacted tax rates and
laws that are expected to be in effect when the differences are
expected to reverse. The Company provides a valuation allowance
against net deferred tax assets unless, based upon the available
evidence, it is more likely than not that the deferred tax
assets will be realized.
Foreign Currency Translation and Transactions
The financial statements of foreign subsidiaries having the
U.S. dollar as the functional currency, with certain
transactions denominated in a local currency, are remeasured
into U.S. dollars. The remeasurement of local currency
amounts into U.S. dollars creates translation adjustments
that are included in net loss. Transaction and translation gains
or losses were not material to the financial statements for any
periods presented.
Comprehensive Income (Loss)
SFAS No. 130, Reporting Comprehensive Income,
requires that all components of comprehensive income (loss),
including net income (loss), be reported in the financial
statements in the period in which they are recognized.
Comprehensive income (loss) is defined as the change in equity
during a period from transactions and other events and
circumstances from nonowner sources. Net income (loss) and other
comprehensive income (loss), including foreign currency
translation adjustments and unrealized gains and losses on
investments shall be reported net of their related tax effect,
to arrive at comprehensive income (loss).
Stock-based Compensation
Effective January 1, 2006, the Company adopted Statement of
Financial Accounting Standards (SFAS) No. 123R,
Share-Based Payment (SFAS No. 123(R)) using the
prospective transition method, and therefore, prior period
results have not been restated. SFAS No. 123(R), which
revises SFAS No. 123, Accounting for Stock-Based
Compensation and (SFAS No. 123), supersedes Accounting
Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees (APB 25), and related
interpretations. Under this transition method, the compensation
cost related to all equity instruments granted prior to, but not
yet vested as of, the adoption date is recognized based on the
grant-date fair value which is estimated in accordance with the
original provisions of SFAS No. 123. Compensation costs
related to all equity instruments granted after January 1,
2006 is recognized at the grant-date fair values of the awards
in accordance with the provisions of SFAS No. 123(R).
Additionally, under the provisions of SFAS No. 123(R), the
Company is required to include an estimate of the number of
awards that will be forfeited in calculating compensation costs,
which is recognized over the requisite service period of the
awards on a straight-line basis.
F-10
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
1. |
Organization and Summary of Significant Accounting Policies
(continued) |
Stock-based Compensation (continued)
For purposes of calculating the stock-based compensation under
SFAS 123(R), the Company estimates the fair value of stock
options using a Black-Scholes option-pricing model which is
consistent with the model used for pro forma disclosures under
SFAS 123 prior to the adoption of SFAS 123(R). The
Black-Scholes option-pricing model was developed for use in
estimating the fair value of short lived exchange traded options
that have no vesting restrictions and are fully transferable. In
addition, the Black-Scholes option-pricing model incorporates
various and highly sensitive assumptions including expected
volatility, expected term and interest rates. The expected
volatility is based on the historical volatility of the
Companys common stock over the most recent period
commensurate with the estimated expected term of the
Companys stock options. The expected term of the
Companys stock options is based on historical experience.
In addition, in accordance with SFAS 123(R) share-based
compensation expense recognized in the statement of operations
for the first quarter of 2006 is based on awards ultimately
expected to vest and is reduced for estimated forfeitures. Prior
to the adoption of SFAS 123(R), the Company used the
minimum value method for valuing stock options granted to
employees and directors. In the Companys pro forma
information required under SFAS 123 for the periods prior
to 2006, the Company accounted for forfeitures as they occurred.
The assumptions used to estimate the fair value of stock options
granted to employee and directors during the nine-months ended
September 30, 2006 and 2005 are as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended | |
|
|
September 30, | |
|
|
| |
|
|
2006 | |
|
2005 | |
|
|
| |
|
| |
|
|
Actual | |
|
Pro Forma | |
Volatility
|
|
|
60 |
% |
|
|
0 |
% |
Expected term (years)
|
|
|
6.0 |
|
|
|
4.0 |
|
Risk free interest rate
|
|
|
4.55 |
% |
|
|
3.00 |
% |
Expected dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
The risk-free interest rate assumption was based on the United
States Treasurys rates for U.S. Treasury zero-coupon bonds
with maturities similar to those of the expected term of the
award being valued. The assumed dividend yield was based on the
Companys expectation of not paying dividends in the
foreseeable future. The weighted average expected life of
options was calculated using the simplified method as prescribed
by the SECs SAB No. 107 (SAB No. 107). This decision was
based on the lack of relevant historical data due to the
Companys limited historical experience. In addition, due
to the Companys limited historical data, the estimated
volatility also reflects the application of SAB No. 107,
incorporating the historical volatility of comparable companies
whose share prices are publicly available.
The weighted average grant-date fair value of stock options
granted during the nine months ended September 30, 2006 was
$7.10 per share.
During the nine months ended September 30, 2006, the
Company recorded approximately $749,000, as a result of the
adoption of SFAS No. 123(R). Of this amount, $89,000
has been capitalized to inventory, $76,000 is included in
research and development expenses and $584,000 is included in
selling, general and administrative expenses.
Total unrecognized stock-based compensation costs related to
non-vested stock options granted during the nine months ended
September 30, 2006 was approximately $7,751,000 as of
September 30, 2006, which
F-11
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
1. |
Organization and Summary of Significant Accounting Policies
(continued) |
Stock-based Compensation (continued)
related to 897,451 shares. This unrecognized cost is
expected to be recognized on a straight-line basis over a
weighted average period of approximately four years.
The following table illustrates the effect on net losses as if
the Company had applied the fair value recognition provisions of
SFAS 123 to determine stock-based compensation for the nine
months ending September 30, 2005:
|
|
|
|
|
|
|
Nine Months Ended | |
|
|
September 30, 2005 | |
(in thousands, except per share amounts) |
|
| |
|
|
(unaudited) | |
Net loss as reported
|
|
$ |
(16,865 |
) |
Add: Stock-based compensation included in net loss
|
|
|
199 |
|
Deduct: Stock-based employee and director compensation
determined under fair value method for all awards
|
|
|
(296 |
) |
|
|
|
|
Pro forma net loss
|
|
$ |
(16,962 |
) |
|
|
|
|
Basic and diluted net loss per share as reported
|
|
$ |
(14.38 |
) |
|
|
|
|
Basic and diluted pro forma net loss per share
|
|
$ |
(14.47 |
) |
|
|
|
|
Equity instruments issued to non-employees are recorded at their
fair values as determined in accordance with SFAS 123,
Accounting for Stock-Based Compensation, and Emerging
Issues Task Force (EITF) 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for
Acquiring, or in Conjunction with Selling Goods and
Services, and are periodically revalued as the options vest
and are recognized as expense over the related service period.
During the years ended December 31, 2003, 2004, 2005, and
for the nine months ended September 30, 2005 and 2006, and
for the period from August 24, 1999 (inception) through
September 30, 2006, we recognized $159,000, $1,024,000,
$959,000, $303,000, $495,000 and $2,691,000, respectively, for
stock options and warrants issued to non-employees.
Deferred Stock-Based Compensation
No employee related stock-based compensation expense was
reflected in the Companys reported net loss in any period
prior to 2004, as all options granted to employees had an
exercise price equal to the estimated fair value of the
underlying common stock on the date of the grant. Stock-based
compensation was recognized in 2004 for warrants granted to a
member of the Board of Directors as the exercise price of the
warrants was less than the estimated fair value of the
underlying common stock on the date of grant.
On September 13, 2005, the Company commenced the initial
public offering process, and based on discussions with its
investment bankers, reassessed the fair value of its common
stock going back to July 1, 2004. The Companys
management, all of whom qualify as related parties, determined
that the stock options granted from July 1, 2004 forward
were granted at exercise prices that were below the reassessed
fair value of the common stock on the date of grant. The Company
completed the reassessment of its fair value without the use of
an unrelated valuation specialist and started with the proposed
valuation from its investment bankers, considering a number of
accomplishments in 2004 and 2005 that would impact its
valuation, including achievement of key clinical milestones,
hiring executive officers, and the increased possibility of
completing an initial public offering. Accordingly, deferred
stock-based compensation of $740,000 was recorded within
Stockholders Equity (deficit) during 2004 which
represented the difference between the
F-12
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
1. |
Organization and Summary of Significant Accounting Policies
(continued) |
Deferred Stock-Based Compensation (continued)
weighted-average exercise price of $4.25 and the
weighted-average fair value of $6.38 on 324,705 options
granted to employees during 2004. Deferred stock-based
compensation of $2,383,000, net of forfeitures, was recorded
within Stockholders Equity (deficit) during 2005 which
represented the difference between the weighted-average exercise
price of $5.31 and the weighted-average fair value of $9.18 on
620,000 options granted to employees during 2005.
The deferred stock-based compensation is being amortized on a
straight-line basis over the vesting period of the related
awards, which is generally four years. The Company recorded
amortization of deferred stock-based compensation expense of
$109,000 and $335,000 during 2004 and 2005 and $444,000 for the
period from August 24, 1999 (inception) through
December 31, 2005.
The expected future amortization expense for deferred
stock-based compensation for stock options granted through
December 31, 2005, is as follows (in thousands):
|
|
|
|
|
2006
|
|
$ |
789 |
|
2007
|
|
|
789 |
|
2008
|
|
|
703 |
|
2009
|
|
|
458 |
|
|
|
|
|
Total
|
|
$ |
2,739 |
|
|
|
|
|
During the years ended December 31, 2003, 2004, 2005, and
for the nine months ended September 30, 2005 and 2006, and
for the period from August 24, 1999 (inception) through
September 30, 2006, we recognized $0, $109,000, $335,000,
$199,000, $561,000 and $1,005,000, respectively, in amortization
of deferred stock-based compensation which was provided for
prior to the adoption of SFAS 123(R).
Unrecognized deferred stock-based compensation related to
non-vested stock option and warrant awards granted prior to
January 1, 2006 was approximately $1,874,509 at
September 30, 2006.
F-13
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
1. |
Organization and Summary of Significant Accounting Policies
(continued) |
Deferred Stock-Based Compensation (continued)
Below is a summary of employee stock option grant activity, net
of forfeitures and exercises, and related fair value information
for the period from August 24, 1999
(inception) through November 27, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value of | |
|
Intrinsic | |
|
|
|
|
|
|
Common Stock | |
|
Value | |
|
|
Shares | |
|
Exercise | |
|
on Date of | |
|
Per | |
Grant date |
|
Granted | |
|
Price | |
|
Grant | |
|
Share | |
|
|
| |
|
| |
|
| |
|
| |
November 1999
|
|
|
17,647 |
|
|
$ |
0.43 |
|
|
$ |
0.43 |
|
|
$ |
|
|
November 1999
|
|
|
470 |
|
|
|
0.64 |
|
|
|
0.64 |
|
|
|
|
|
February 2000
|
|
|
5,882 |
|
|
|
0.64 |
|
|
|
0.64 |
|
|
|
|
|
May 2000
|
|
|
5,882 |
|
|
|
0.64 |
|
|
|
0.64 |
|
|
|
|
|
September 2000
|
|
|
5,882 |
|
|
|
2.34 |
|
|
|
2.34 |
|
|
|
|
|
December 2000
|
|
|
20,000 |
|
|
|
2.34 |
|
|
|
2.34 |
|
|
|
|
|
April 2001
|
|
|
2,352 |
|
|
|
2.34 |
|
|
|
2.34 |
|
|
|
|
|
November 2001
|
|
|
91,764 |
|
|
|
1.49 |
|
|
|
1.49 |
|
|
|
|
|
April 2002
|
|
|
11,764 |
|
|
|
1.49 |
|
|
|
1.49 |
|
|
|
|
|
March 2003
|
|
|
9,411 |
|
|
|
6.38 |
|
|
|
6.38 |
|
|
|
|
|
June 2003
|
|
|
27,058 |
|
|
|
6.38 |
|
|
|
6.38 |
|
|
|
|
|
September 2004
|
|
|
356,470 |
|
|
|
4.25 |
|
|
|
6.38 |
|
|
|
2.12 |
|
April 2005
|
|
|
183,823 |
|
|
|
5.31 |
|
|
|
6.93 |
|
|
|
1.62 |
|
June 2005
|
|
|
8,235 |
|
|
|
5.31 |
|
|
|
6.93 |
|
|
|
1.62 |
|
September 2005
|
|
|
9,411 |
|
|
|
5.31 |
|
|
|
9.39 |
|
|
|
4.08 |
|
December 2005
|
|
|
392,941 |
|
|
|
5.31 |
|
|
|
10.41 |
|
|
|
5.10 |
|
March 2006 (unaudited)
|
|
|
292,941 |
|
|
|
5.31 |
|
|
|
11.69 |
|
|
|
6.38 |
|
September 2006 (unaudited)
|
|
|
691,764 |
|
|
|
7.86 |
|
|
|
12.75 |
|
|
|
4.89 |
|
November 7, 2006 (unaudited)
|
|
|
691,764 |
|
|
|
7.86 |
|
|
|
12.75 |
|
|
|
4.89 |
|
November 27, 2006 (unaudited)
|
|
|
335,246 |
|
|
|
10.63 |
|
|
|
13.00 |
|
|
|
2.37 |
|
Upon the adoption of SFAS No. 123(R) on
January 1, 2006, deferred stock-based compensation was
reclassified against additional paid-in capital.
As of September 30, 2006, 1,869,783 options to purchase
common stock were outstanding, of this number 484,148 options
were vested and 1,385,635 options were unvested. The intrinsic
value of the vested and unvested stock options outstanding was
$4,151,850 and $8,757,119, respectively.
F-14
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
1. |
Organization and Summary of Significant Accounting Policies
(continued) |
The stock-based compensation expense that has been included in
the statement of operations for all stock-based compensation
arrangements was as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine Months | |
|
|
Ended | |
|
|
September 30, | |
|
|
| |
|
|
2005 | |
|
2006 | |
(in thousands, except per share amounts) |
|
| |
|
| |
|
|
(unaudited) | |
Capitalized to inventory
|
|
$ |
|
|
|
$ |
214 |
|
|
|
|
|
|
|
|
Research and development expense
|
|
$ |
113 |
|
|
$ |
267 |
|
Sales, general and administrative expense
|
|
|
389 |
|
|
|
1,324 |
|
|
|
|
|
|
|
|
|
|
$ |
502 |
|
|
$ |
1,591 |
|
|
|
|
|
|
|
|
Net effect on basic and diluted net loss per share
|
|
$ |
0.43 |
|
|
$ |
1.18 |
|
|
|
|
|
|
|
|
Recently Issued Accounting Standards
In November 2004, the FASB issued SFAS No. 151,
Inventory Costs, an amendment of ARB No. 43,
Chapter 4. This statement amends the guidance in ARB
No. 43, Chapter 4, Inventory Pricing, to
clarify the accounting for abnormal amounts of unallocated
overhead resulting from abnormally low production (or idle
capacity), freight, handling costs, and wasted material
(spoilage). This statement requires that those items be
recognized as current-period charges. In addition, this
statement requires that allocation of fixed production overheads
to the costs of conversion be based on the normal capacity of
the production facilities. The provisions of this statement will
be effective for inventory costs during the fiscal years
beginning after June 15, 2005. The Company is still
evaluating the impact the adoption of this statement will have
on its financial condition and results of operations.
|
|
2. |
Net Loss Per Common Share |
Basic net loss per common share is calculated by dividing the
net loss by the weighted-average number of common shares
outstanding for the period, without consideration for common
stock equivalents. Diluted net loss per common share is computed
by dividing the net loss by the weighted-average number of
common share equivalents outstanding for the period determined
using the treasury-stock method. For purposes of this
calculation, convertible preferred stock, stock options and the
outstanding warrants are considered to be common stock
equivalents and are only included in the calculation of diluted
net loss per share when their effect is dilutive.
F-15
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
2. |
Net Loss Per Common Share (continued) |
Historical outstanding anti-dilutive securities on an
as-if-converted method not included in the diluted net loss per
common calculation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended | |
|
|
December 31, | |
|
September 30, | |
|
|
| |
|
| |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
(unaudited) | |
Convertible preferred stock
|
|
|
1,686,545 |
|
|
|
1,712,800 |
|
|
|
5,307,180 |
|
|
|
4,492,212 |
|
|
|
9,367,511 |
|
Warrants to purchase preferred and common stock
|
|
|
638,431 |
|
|
|
1,566,653 |
|
|
|
2,423,758 |
|
|
|
2,366,486 |
|
|
|
3,365,534 |
|
Options to purchase common stock
|
|
|
375,003 |
|
|
|
560,470 |
|
|
|
1,149,000 |
|
|
|
2,405,176 |
|
|
|
1,869,676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,699,979 |
|
|
|
3,839,923 |
|
|
|
8,879,938 |
|
|
|
9,263,874 |
|
|
|
14,602,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma Net Loss per Common Share
Management believes that the additional disclosure below is
useful to investors because it shows what basic loss per share
would have been if the conversions of the Companys
preferred stock had occurred at the beginning of the respective
periods being reported rather than during the periods.
The calculation of unaudited pro forma basic and diluted net
loss per common share assumes the conversion of all shares of
Series A, Series B, Series C-1, Series D and
Series E convertible preferred stock into shares of common
stock using the as-if-converted method, as if such conversion
had occurred as of January 1, 2003, or the original
issuance date, if later.
F-16
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
2. |
Net Loss Per Common Share (continued) |
Pro Forma Net Loss per Common Share (continued)
The Companys pro forma net loss per share is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended | |
|
|
Years Ended December 31, | |
|
September 30, | |
|
|
| |
|
| |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
(unaudited) | |
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, as reported (in thousands)
|
|
$ |
(6,120 |
) |
|
$ |
(12,385 |
) |
|
$ |
(22,243 |
) |
|
$ |
(16,865 |
) |
|
$ |
(18,569 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share
|
|
|
1,062,825 |
|
|
|
1,106,188 |
|
|
|
1,185,387 |
|
|
|
1,172,419 |
|
|
|
1,344,503 |
|
Pro forma adjustments to reflect assumed weighted-average effect
of conversion of preferred stock on January 1, 2003, 2004
and 2005, respectively
|
|
|
1,163,291 |
|
|
|
1,712,800 |
|
|
|
3,134,024 |
|
|
|
3,447,913 |
|
|
|
8,540,499 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma shares used in basic and diluted pro forma net loss
per share
|
|
|
2,226,116 |
|
|
|
2,818,988 |
|
|
|
4,319,411 |
|
|
|
4,620,332 |
|
|
|
9,885,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and diluted net loss per share attributable to
common stockholders
|
|
$ |
(2.75 |
) |
|
$ |
(4.39 |
) |
|
$ |
(5.15 |
) |
|
$ |
(3.65 |
) |
|
$ |
(1.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On July 22, 2004, the Company acquired worldwide patents
and patent rights to polymethylmethacrylate (PMMA)
microspheres for polymer and alloplastic implants from a
shareholder of the Company for $500,000, excluding direct
acquisition related expenses of $34,000. The Company paid
$250,000 in December 2003 and the remaining $250,000 in
installments through July 2004. The Company took ownership of
this intellectual property effective January 1, 2004.
On July 22, 2004, the Company also acquired 100% of the
outstanding shares in Artes Medical Germany GmbH (formerly
Mediplant GmbH Biomaterials & Medical Devices)
(Mediplant) from FormMed Biomedicals AG. FormMed
Biomedicals AGs sole shareholder is a Company shareholder.
Mediplant possessed certain related trademarks and manufacturing
process know-how, for the manufacture of PMMA materials, an
integral component of the Companys product ArteFill. After
the acquisition, the Company initiated process development and
validation activities. Under the purchase agreement the Company
took effective control of Mediplant on January 1, 2004, and
began consolidating the financial statements of Mediplant with
those of the Company as of that date. The total purchase price
for this acquisition was $3,750,000, excluding direct
acquisition expenses of $265,000.
F-17
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
3. |
Acquisitions (continued) |
The acquisition of the worldwide patents and patent rights to
PMMA microspheres for polymer and alloplastic implants and
Mediplant were considered linked transactions. Both transactions
were considered asset acquisitions and were accounted for under
the purchase method of accounting; and, accordingly, the
purchased assets and liabilities assumed were recorded at their
estimated fair values at the date of the acquisition.
The following table summarizes the total purchase price,
estimated fair values of the assets acquired and liabilities
assumed, and the resulting net intangible assets acquired at the
date of the acquisition for both of the linked transactions (in
thousands):
|
|
|
|
|
|
|
|
|
|
Total purchase price, including acquisition related expenses
|
|
|
|
|
|
$ |
4,549 |
|
Allocated to assets and liabilities:
|
|
|
|
|
|
|
|
|
Tangible net assets acquired:
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
$ |
208 |
|
|
|
|
|
|
Other assets
|
|
|
33 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net tangible assets acquired
|
|
|
241 |
|
|
|
|
|
Total liabilities assumed
|
|
|
2,847 |
|
|
|
|
|
|
|
|
|
|
|
|
Net liabilities assumed
|
|
|
|
|
|
|
2,606 |
|
|
|
|
|
|
|
|
Net intangible assets acquired
|
|
|
|
|
|
$ |
7,155 |
|
|
|
|
|
|
|
|
Based on a third-party valuation, net intangible assets acquired
were allocated to patents of $287,000 and core technology of
$4,030,000. However, there was no allocation of the purchase
price to these intangibles for tax purposes, and
Mediplants tax basis in the intangibles remained zero.
EITF 98-11 requires the recognition of the deferred tax
impact of acquiring an asset in a transaction that is not a
business combination when the amount paid exceeds the tax basis
of the asset on the acquisition date. Further, EITF 98-11
requires the use of simultaneous equations to determine the
assigned value of an asset and the related deferred tax
liability. Using the prescribed methodology, the Company
assigned a value of $6,868,000 to the core technology and
$2,838,000 to the related deferred tax liability. The
weighted-average useful life of the patents and core technology
was estimated to be six years. Accumulated amortization at
December 31, 2005 was $96,000 for patents and $2,289,000
for core technology. Accumulated amortization at
September 30, 2006 was $132,000 for patents and $3,148,000
for core technology. Amortization expense for patents and core
technology is estimated to be $1,192,000 for each year from 2006
to 2009.
MediPlant Acquisition Settlement Agreement
In October 2005, the Company, FormMed Biomedicals AG, and
Dr. Martin Lemperle, one of the Companys founders,
entered into a settlement agreement to accelerate the two
installment payments due under the original purchase agreement
dated July 22, 2004, and to settle and mutually release all
parties regarding reimbursement of certain production and
development costs incurred by FormMed prior to the date of the
purchase agreement and reimbursement to Dr. Lemperle of
certain legal expenses. Upon final settlement of the litigation
with one of the Companys competitors (see Note 5) and
receipt of the settlement amount in 2005, the Company paid
FormMed $750,000 as the final payment and secured the release of
certain tangible and intangible assets held in escrow, as per
the original MediPlant purchase agreement.
The Company agreed to pay FormMed 428,000 Euro for the prior
production and development costs on a payment schedule through
June 30, 2006. In addition, the Company issued FormMed
7,214 shares of
F-18
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
3. |
Acquisitions (continued) |
MediPlant Acquisition Settlement Agreement (continued)
Company common stock as consideration for accrued interest. The
Company agreed to pay Dr. Martin Lemperle 150,000 Euro by
June 30, 2006 for all legal costs incurred as a result of
the settlement and litigation agreements with a competitor (see
Note 5). In addition, the Company issued Dr. Martin
Lemperle 2,549 shares of Company common stock as
consideration for accrued interest.
All parties agreed that both the cash payments and common stock
grant covers in full all prior period production, development
and legal costs incurred by FormMed and Dr. Martin
Lemperle. In the event that the Company completes an Initial
Public Offering (IPO) prior to June 30, 2006,
all unpaid amounts are payable within twenty (20) days upon
closing of such IPO.
Other Assets
Other current assets consist primarily of a receivable for
tenant improvement allowances provided by the Companys
landlord. Other noncurrent assets consist of capitalized direct
financing costs which are amortized to interest expense and
various deposits with vendors and professional service providers.
Deferred Financing Costs
Deferred financing costs consist of amounts related to the
issuance of common stock and common stock warrants issued in
connection with a modification of terms of certain convertible
notes payable. These amounts will be expensed to interest
expense using the effective interest method over the modified
term of the agreement.
Inventory
Inventory consists of raw materials used in the manufacture of
ArteFill. Inventory is carried at the lower of cost or market.
Cost is determined using the average-cost method with provisions
made for obsolete or slow moving goods.
Inventory consisted of the following at (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
September 30, | |
|
|
| |
|
| |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(unaudited) | |
Raw materials
|
|
$ |
367 |
|
|
$ |
929 |
|
|
$ |
2,130 |
|
Work in process
|
|
|
|
|
|
|
|
|
|
|
2,267 |
|
Less: reserve for obsolete inventory
|
|
|
(117 |
) |
|
|
(237 |
) |
|
|
(378 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
250 |
|
|
$ |
692 |
|
|
$ |
4,019 |
|
|
|
|
|
|
|
|
|
|
|
F-19
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
4. |
Balance Sheet Details (continued) |
Property and Equipment
Property and equipment consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
September 30, | |
|
|
| |
|
| |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(unaudited) | |
Furniture and fixtures
|
|
$ |
97 |
|
|
$ |
385 |
|
|
$ |
539 |
|
Office equipment
|
|
|
123 |
|
|
|
471 |
|
|
|
729 |
|
Lab equipment
|
|
|
390 |
|
|
|
1,820 |
|
|
|
2,273 |
|
Leasehold improvements
|
|
|
406 |
|
|
|
2,894 |
|
|
|
3,401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,016 |
|
|
|
5,570 |
|
|
|
6,942 |
|
Less accumulated depreciation and amortization
|
|
|
(95 |
) |
|
|
(644 |
) |
|
|
(1,523 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
921 |
|
|
$ |
4,926 |
|
|
$ |
5,419 |
|
|
|
|
|
|
|
|
|
|
|
Total depreciation expense for the years ended December 31,
2003, 2004 and 2005 and for the nine months ended
September 30, 2005 and 2006, and the period from
August 24, 1999 (inception) through September 30,
2006, was $35,000, $42,000, $549,000, $316,000, $892,000 and
$1,583,000, respectively.
|
|
5. |
Commitments and Contingencies |
The Company leases equipment under various equipment financing
arrangements ranging in term from one to three years with
interest rates ranging from 8.5% to 9.3%.
Future principal payments under the Companys equipment
financing arrangements are as follows (in thousands):
|
|
|
|
|
Years ended December 31,
|
|
|
|
|
2006
|
|
$ |
49 |
|
2007
|
|
|
45 |
|
2008
|
|
|
21 |
|
|
|
|
|
Total
|
|
$ |
115 |
|
|
|
|
|
The Company executed a new building lease, which commenced
January 1, 2005 and expires in December 2011. On
June 1, 2005, the Company executed a new building lease for
additional office space. The lease began on June 1, 2005
and expires on March 30, 2011. Various types of office
equipment are also being leased under operating leases.
F-20
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
5. |
Commitments and Contingencies (continued) |
Future annual minimum rental payments under the Companys
operating leases are as follows (in thousands):
|
|
|
|
|
Years ended December 31,
|
|
|
|
|
2006
|
|
$ |
867 |
|
2007
|
|
|
956 |
|
2008
|
|
|
985 |
|
2009
|
|
|
1,036 |
|
2010
|
|
|
1,087 |
|
Thereafter
|
|
|
990 |
|
|
|
|
|
Total minimum lease payments
|
|
$ |
5,921 |
|
|
|
|
|
Rent expense was $110,000, $435,000, $954,000, $625,000 and
$682,000 for the years ended December 31, 2003, 2004 and
2005 and for the nine months ended September 30, 2005 and
2006, respectively, and $2,478,000 for the period from
August 24, 1999 (inception) through September 30,
2006.
The Company is subject to various legal actions and proceedings
in the normal course of business. While the ultimate outcome of
these matters cannot be predicted with certainty, management
does not believe these matters will have a material adverse
effect on the Companys financial statements.
Litigation Settlement Agreement
On October 31, 2005, the Company and Dr. Martin
Lemperle, one of the Companys founders, resolved all of
their outstanding disputes and litigation matters with an
independent company competing in the aesthetics market (the
Competitor). According to the terms of the
settlement agreement, the Company has granted the Competitor an
exclusive, world-wide license under certain of its patents to
make and sell implant products containing Calcium
Hydroxylapatite particles, and a nonexclusive, world-wide
license under the same patents to make and sell certain other
nonpolymeric implant products. The Competitor paid the Company
$2,058,000 in November 2005 for the settlement plus past
royalties. This amount is included in other income in the 2005
consolidated statements of operations.
Legal Representation Settlement Agreement
In November 2005, the Company and a legal firm entered into a
settlement agreement regarding disputed legal expenses incurred
prior to 2004 while the legal firm was representing the Company
on a certain litigation matter. The Company paid $225,000 in
2005 for a negotiated amount of unpaid legal expenses in
exchange for a full and mutual release of claims between the two
parties.
|
|
6. |
Convertible Notes Payable |
In 2000 and 2001, the Company issued unsecured convertible notes
payable to stockholders of the Company in the amount of
$1,510,000 (2000 Notes). The 2000 Notes bore
interest at an annual rate of 8%. In July 2003, $1,477,000 of
principal and $335,000 in accrued interest was converted into
659,069 shares of Series C-1 preferred stock at a
conversion rate of $2.75 per share.
The remaining $33,000 of principal that was not converted and
$12,000 of accrued interest is included in convertible notes
payable on the December 31, 2004 and the $33,000 of
principal and $15,000 of accrued
F-21
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
6. |
Convertible Notes Payable (continued) |
interest is included in convertible notes payable on the
December 31, 2005 consolidated balance sheets. For the
years ended December 31, 2003, 2004 and 2005, and for the
nine months ended September 30, 2005 and 2006, and for
the period from August 24, 1999 (inception) to
September 30, 2006, the Company recorded $70,000, $4,000,
$4,000, $3,000, $1,000 and $353,000 of interest expense
associated with the 2000 Notes, respectively.
In 2002 and 2003, the Company issued unsecured convertible notes
payable to stockholders of the Company in the amount of
$2,615,000 (2002 Notes). The 2002 Notes bore
interest at an annual rate of 12%. In July 2003, $2,615,000 of
principal and $213,000 in accrued interest was converted into
2,827,864 shares of Series C-1 preferred stock at a
conversion rate of $1.00 per share.
For the years ended December 31, 2003, 2004 and 2005, and
for the nine months ended September 30, 2005 and 2006,
and for the period from August 24, 1999 (inception) to
September 30, 2006, the Company recorded $163,000, $0, $0,
$0, $0 and $213,000 of interest expense associated with the 2002
Notes, respectively.
In December 2003 and throughout 2004, the Company received
bridge loan financing by issuing unsecured convertible notes
payable (2004 Notes) in the amount of $6,736,000.
The 2004 Notes bore interest at an annual rate of 8%. In May
2005, $6,736,000 of principal and $501,000 in accrued interest
was converted into 5,789,801 shares of Series D
preferred stock at a conversion rate of $1.25 per share.
For the years ended December 31, 2004 and 2005, and for the
nine months ended September 30, 2005 and 2006, and for
the period from August 24, 1999 (inception) through
September 30, 2006, the Company recorded $322,000,
$179,000, $179,000, $0 and $501,000 of interest expense
associated with the 2004 Notes, respectively.
In connection with the 2004 Notes, the Company issued warrants
to purchase 634,016 shares of common stock to the
holders of the 2004 Notes during the year ended
December 31, 2004. The warrants are fully vested and have
an exercise price of $5.31. The proceeds from the 2004 Notes
were allocated to the carrying values of the notes and the
warrants on the basis of their relative fair values on the date
of issuance.
In accordance with
EITF 00-27,
Application of Issue No. 98-5 to Certain Convertible
Instruments, the Company initially recorded its convertible debt
net of a discount for the (i) the estimated fair value of
the warrants issued in the amount of $2,667,500 and
(ii) the intrinsic value of the related beneficial
conversion feature in the same amount for a total of $5,335,000.
The estimated fair value of the warrants was determined in
accordance with the Black-Scholes valuation model. The discount
associated with the warrants and beneficial conversion feature
is being amortized to interest expense over the term of the
outstanding convertible notes payable. Interest expense related
to the warrants and beneficial conversion features was
$3,555,000, $1,780,000, $1,780,000, $0 and $5,335,000 for the
years ended December 31, 2004 and 2005, and for the
nine months ended September 30, 2005 and 2006, and for
the period from August 24, 1999 (inception) to
September 30, 2006.
In May 2005, the Company received $6,970,000 in proceeds by
issuing unsecured convertible promissory notes (2005
Bridge Loan) that were to accrue simple interest at
10% per annum until the maturity date of November 3,
2005. At the sole discretion of the Company, the maturity date
was subject to a one-time extension to February 3, 2006.
The Company exercised its right of the one-time extension, the
applicable interest rate increased to 12% retroactively to the
date of issuance of the 2005 Bridge Loan. At the closing of the
next equity financing, the holders of the 2005 Bridge Loan
elected not to convert all or a portion of the outstanding
principal and accrued but unpaid interest into the new equity
shares at the per share price of those shares but rather to be
repaid the balance due under the 2005 Bridge Loan.
F-22
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
6. |
Convertible Notes Payable (continued) |
Simultaneously upon issuance of the 2005 Bridge Loan, the
Company issued warrants to purchase Series D convertible
preferred stock equal to 30% of the principal amounts of the
2005 Bridge Loan divided by the warrant exercise price of $2.00
per share or warrants to purchase 1,045,500 shares of
Series D convertible preferred stock. The warrants expire
in May 2010.
In accordance with
EITF 00-27,
Application of Issue No. 98-5 to Certain Convertible
Instruments, the Company initially recorded its convertible debt
net of a discount for the (i) the estimated fair value of
the warrants issued in the amount of $1,003,500 and
(ii) the intrinsic value of the related beneficial
conversion feature in the same amount for a total of $2,007,000.
The estimated fair value of the warrants was determined in
accordance with the Black-Scholes valuation model. The discount
associated with the warrants and beneficial conversion feature
is being amortized to interest expense over the term of the
outstanding convertible notes payable.
Interest expense related to the warrants and beneficial
conversion features was $1,772,000, $1,062,000, $235,000 and
$2,007,000 for the year ended December 31, 2005, and for
the nine months ended September 30, 2005 and 2006, and for
the period from August 24, 1999 (inception) to
September 30, 2006.
On September 30, 2005, outstanding principal amount of
$970,000 and accrued interest of $39,000 converted into
403,412 shares of Series E convertible preferred stock
at a rate of $2.50 per share.
The Company had $492,000 in accrued interest included in
convertible notes payable on the December 31, 2005 balance
sheet.
On December 30, 2005, the Company entered into an amendment
of the 2005 Bridge Loan with an investor representing an
outstanding principal amount of $5,500,000, whereby the Company
paid, in January 2006, a total of $3,246,000, consisting of
$3,000,000 of outstanding principal and $246,000 of accrued
interest, upon the second closing of the Series E
Financing. In February 2006, upon the third closing of
Series E convertible preferred stock, the Company paid an
additional $2,738,000, consisting of $2,500,000 of outstanding
principal and $238,000 of accrued interest, the final amount due
under the 2005 Bridge Loan.
Per the note amendment, the investor waived both its conversion
and redemption options under the original note and extended the
due date of the remaining outstanding principal of $2,500,000
from February 3, 2006 to February 15, 2006. As
additional consideration, the Company granted the investor a
stock grant of 250,000 shares of Series E convertible
preferred stock in December 2005. In addition, three Company
directors personally guaranteed the remaining outstanding
principal under the amended note agreement. In exchange for the
personal guarantees, the three Company directors were given
23,529 shares of common stock. At December 31, 2005,
the common stock had not yet been issued and is included as
common stock issuable in the 2005 consolidated balance sheet and
the consolidated statement of shareholders equity
(deficit).
|
|
7. |
Stockholders Equity (Deficit) |
Convertible Preferred Stock
In May 2005, the Company issued 5,789,801 shares of
Series D convertible preferred stock at $1.25 per
share and 4,230,055 shares of Series D convertible
preferred stock at $2.00 per share for a total of $15,197,000
and interest accrued to the holders of the 2004 convertible
notes payable (2004 Notes) of $500,000. The total investment is
comprised of $8,460,000 of Series D preferred stock
subscriptions converting to 4,230,055 shares of
Series D convertible preferred stock and $7,237,000 of
convertible promissory notes
F-23
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Convertible Preferred Stock (continued)
payable (2004 Notes), including accrued interest of $500,000,
converting to 5,789,801 shares of Series D convertible
preferred stock.
Certain purchasers of Series D convertible preferred stock
received a warrant to purchase one share of common stock for
each five shares of Series D convertible preferred stock
purchased, or 842,969 warrants to purchase common stock, at an
exercise price of $2.00 per share. The warrants may be
exercised any time for a period of five years. The purchasers
that were issued shares of Series D convertible preferred
stock in connection with the conversion of promissory notes
previously issued by the Company did not receive such warrants.
In August 2005, the Company obtained shareholder approval to
open an offering to sell approximately ten million shares of
Series E convertible preferred stock at $2.50 per
share for gross proceeds of $25 million (the
Series E Financing).
The Series E Financing closed in five rounds from December
2005 through March 2006 resulting in gross proceeds of
$50.7 million, including the conversion of $1,009,000 of
the outstanding 2005 Bridge Loan and related accrued interest.
On December 22, 2005, the first round closed with total
proceeds of $7.7 million, including the conversion of
$970,000 of the outstanding 2005 Bridge Loan and $39,000 of
accrued interest, resulting in the issuance of
3,213,615 shares of Series E convertible preferred
stock. Cash proceeds were received of $6.7 million for the
purchase of 2,686,203 shares. An additional
403,412 shares were issued for the conversion of $1,009,000
of the outstanding 2005 Bridge Loan including accrued interest
of $39,000.
In December 2005, the Company engaged a placement agent to
secure the sale of up to $10 million in additional
Series E convertible preferred stock. A purchaser of less
than $5.0 million of Series E convertible preferred
stock would receive a warrant to purchase one share of common
stock for each five shares of Series E convertible
preferred stock purchased, or 20% of the amount purchased. A
purchaser of $5.0 million or more of Series E
convertible preferred stock would receive a warrant to purchase
one share of common stock for each 14.0 shares of
Series E convertible preferred stock purchased, or 30% of
the amount purchased. The warrants have an exercise price of
$10.63 per share. The warrants may be exercised any time
for a period of five years.
On January 6, 2006, the Company closed the second round of
its Series E Financing. Upon closing, total gross proceeds
of $6,750,000 were received resulting in the issuance of
2,700,000 shares of Series E convertible preferred
stock and warrants for the future purchase of
702,000 shares of convertible Series E convertible
preferred stock at $2.50 per share. The warrants expire
January 6, 2011. In addition, the Company issued a warrant
for the future purchase of 16,875 shares of common stock at
$1.25 per share. This warrant expires January 6, 2011.
On January 13, 2006, the Company closed the third round of
Series E Financing. Upon closing, total gross proceeds of
$3,235,000 were received resulting in the issuance of
1,294,000 shares of Series E convertible preferred
stock and warrants for the future purchase of
536,440 shares of Series E convertible preferred stock
at $2.50 per share. The warrants expire January 13,
2011. In addition, the Company issued a warrant for the future
purchase of 8,088 shares of common stock at $1.25 per
share. This warrant expires January 13, 2011.
On February 14, 2006, the Company closed its fourth round
of Series E Financing. Upon closing, total gross proceeds
of $13,711,000 were received resulting in the issuance of
5,484,200 shares of Series E convertible
F-24
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Convertible Preferred Stock (continued)
preferred stock and warrants for the future purchase of
948,420 shares of convertible Series E convertible
preferred stock at $2.50 per share. The warrants expire
February 14, 2011. In addition, the Company issued a
warrant for the future purchase of 5,727 shares of common
stock at $1.25 per share. This warrant expires
February 14, 2011.
On March 28, 2006, the Company closed the fifth and final
round of Series E Financing. Upon closing, total gross
proceeds of $19,281,000 were received resulting in the issuance
of 7,712,406 shares of Series E convertible preferred
stock and warrants for the future purchase of
1,451,582 shares of Series E convertible preferred
stock at $2.50 per share. The warrants expire
March 28, 2011.
In October 2005, the Company entered into a termination
agreement with certain financial advisors. In exchange for the
termination agreement the Company issued 124,000 shares of
Series E convertible preferred stock at $2.50 per
share. The Company expensed $310,000 as stock-based compensation
during the year ended December 31, 2005 related to this
termination agreement.
As of December 31, 2005, the Company had received
$6.9 million in subscriptions for Series E convertible
preferred stock.
At December 31, 2004, 2005 and September 30, 2006, the
Company was authorized to issue 25,000,000 35,000,000 and
50,000,000 shares of preferred stock, respectively.
|
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December 31, | |
|
September 30, | |
|
|
| |
|
| |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(unaudited) | |
|
|
|
|
Shares Issued | |
|
Aggregate | |
|
|
|
Shares Issued | |
|
Aggregate | |
|
|
|
Shares Issued | |
|
Aggregate | |
|
|
Shares | |
|
and | |
|
Liquidation | |
|
Shares | |
|
and | |
|
Liquidation | |
|
Shares | |
|
and | |
|
Liquidation | |
|
|
Designated | |
|
Outstanding | |
|
Preference | |
|
Designated | |
|
Outstanding | |
|
Preference | |
|
Designated | |
|
Outstanding | |
|
Preference | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
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| |
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| |
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| |
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| |
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|
|
(in thousands) | |
|
|
|
|
|
(in thousands) | |
|
|
|
|
|
(in thousands) | |
Series A
|
|
|
2,050,839 |
|
|
|
2,050,839 |
|
|
$ |
3,076 |
|
|
|
2,050,839 |
|
|
|
2,050,839 |
|
|
$ |
3,076 |
|
|
|
2,050,839 |
|
|
|
2,050,839 |
|
|
$ |
3,076 |
|
Series B
|
|
|
679,239 |
|
|
|
679,239 |
|
|
|
2,262 |
|
|
|
679,239 |
|
|
|
679,239 |
|
|
|
2,262 |
|
|
|
679,239 |
|
|
|
679,239 |
|
|
|
2,262 |
|
Series C-1
|
|
|
7,052,741 |
|
|
|
4,437,741 |
|
|
|
12,204 |
|
|
|
7,052,741 |
|
|
|
4,437,741 |
|
|
|
12,204 |
|
|
|
7,052,741 |
|
|
|
4,487,741 |
|
|
|
12,341 |
|
Series D
|
|
|
11,000,000 |
|
|
|
|
|
|
|
|
|
|
|
11,500,000 |
|
|
|
10,019,857 |
|
|
|
20,040 |
|
|
|
11,000,000 |
|
|
|
10,019,857 |
|
|
|
20,040 |
|
Series E
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000,000 |
|
|
|
3,463,615 |
|
|
|
8,659 |
|
|
|
25,000,000 |
|
|
|
20,654,221 |
|
|
|
51,636 |
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,782,819 |
|
|
|
7,167,819 |
|
|
$ |
17,542 |
|
|
|
31,282,819 |
|
|
|
20,651,291 |
|
|
$ |
46,241 |
|
|
|
46,282,819 |
|
|
|
37,891,897 |
|
|
$ |
89,355 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Conversion
Each share of Series A, B, C-1, D and E convertible
preferred stock is convertible into one share of common stock at
the option of the holder at an initial conversion price of
$6.38, $14.15, $11.69, $8.50 and $10.63 per share,
respectively, subject to anti-dilution adjustments.
Each share of preferred stock shall automatically be converted
to common stock immediately prior to the closing of a firmly
written public offering pursuant to an effective registration
statement under the Securities Act of 1933, as amended, covering
the offer and sale of common stock of the Company in which the
per share price is at least $10.00 per share and the gross
proceeds exceed $25,000,000.
The Companys existing Fifth Amended and Restated
Certificate of Incorporation provides that each outstanding
share of preferred stock will automatically convert into shares
of common stock upon the earlier of: (i) the Companys
sale of its common stock in a firm commitment underwritten
public offering pursuant to a registration statement under the
Securities Act of 1933, as amended, the public offering price of
which is not less than $10.00 per share (adjusted to
reflect subsequent stock dividends, stock splits or recapitaliza-
F-25
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Conversion (continued)
tions) and which results in aggregate cash proceeds of at least
$25,000,000 (net of underwriting discounts and commissions);
(ii) the date on which the Company first becomes subject to
the periodic reporting requirements of Section 12(g) or
Section 15(d) of the Securities Exchange Act of 1934, as
amended; or (iii) the date specified by written consent or
agreement of the holders of a majority of the then outstanding
shares of preferred stock, voting together as a single class on
an as-converted-to
common stock basis. The Company has requested its preferred
stockholders to execute a written consent that provides for the
automatic conversion of the preferred stock immediately prior to
the closing date of the Companys proposed initial public
offering. The Company currently believes this written consent
will be executed by the holders of more than a majority of the
outstanding shares of preferred stock in accordance with
item (iii) above.
Dividends
The holders of the Series A, B, C-1, D and E convertible
preferred stock are entitled to receive noncumulative dividends
at $0.12, $0.26, $0.22, $0.16 and $0.20 per share,
respectively, per annum only when and if declared by the Board
of Directors. To date, the Board of Directors has not declared
any dividends.
Voting Rights
The holders of the Series A, B, C-1, D and E convertible
preferred stock are also entitled to the number of votes equal
to the number of shares of common stock into which each share of
preferred stock is convertible on the record date for the vote,
and have voting rights and powers equal to the common stock.
Liquidation
The holders of the Series A, B, C-1, D and E convertible
preferred stock are also entitled to receive liquidation
preferences at the rate of $1.50, $3.33, $2.75, $2.00 and
$2.50 per share, respectively. Liquidation payments are
made in preference to any payments to the holders of common
stock and will be made with the following priority to the
preferred stockholders: Series B, Series A,
Series C-1, Series D and then Series E.
Anti-Dilution Provisions
The issuance of Series C-1 convertible preferred stock in
2003 triggered the anti-dilution provisions of Series B
convertible preferred stock. The common shares that the
outstanding Series B preferred shares would convert into
increased by 111,585 to 790,824 shares of common stock.
The issuance of Series D convertible preferred stock in
2005 triggered the anti-dilution provisions of the Series B
and Series C-1 convertible preferred stock. The common
shares that the outstanding Series B preferred shares would
convert into increased by 125,444 shares to
919,368 shares of common stock and the common shares that
the outstanding Series C-1 preferred shares would convert
into increased by 1,664,097 shares to 6,101,838 shares
of common stock.
Stock Option Plans
In 2001, the Company adopted the 2001 Stock Option Plan (the
2001 Plan) for eligible employees, officers,
directors, advisors, and consultants that provides for the grant
of incentive and nonstatutory stock options. The 2001 Plan
supersedes the 2000 Stock Option Plan (the 2000
Plan). The Company has 2,352,941 shares of common
stock options authorized under the 2001 Plan. Terms of the stock
option
F-26
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Stock Option Plans (continued)
agreements, including vesting requirements, are determined by
the Board of Directors, subject to the provisions of the 2001
Plan. Options granted by the Company generally vest over four
years and vested options are exercisable from the date of grant
for a period of ten years. The exercise price of the incentive
stock options must equal at least the fair market value of the
stock on the date of grant.
The exercise price of nonstatutory stock options must equal at
least 85% of the fair market value of the stock on the date of
grant. The exercise price of any incentive stock option granted
to a 10% stockholder may be no less than 110% of the fair value
of the Companys common stock on the date of grant. As of
December 31, 2005, there were 28,235 and 1,090,882 options
outstanding under the 2000 and 2001 Plans, respectively, and
29,880 options granted outside the 2000 and 2001 Plans.
The Company recorded stock-based compensation for options
granted to nonemployees of $54,000, $112,000, $107,000, $79,000,
$78,000 and $406,000 for the years ended December 31, 2003,
2004 and 2005, and for the nine months ended September 30,
2005 and 2006, and for the period from August 24, 1999
(inception) through September 30, 2006, respectively.
The fair value of each option was determined using the
Black-Scholes valuation model and periodically re-measured and
recognized over the related service period.
F-27
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Stock Option Plans (continued)
The following table summarizes stock option activity under the
Plans, as well as outside the Plans (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average | |
|
|
Options | |
|
Exercise Price | |
|
|
| |
|
| |
August 24, 1999 (inception)
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
71 |
|
|
$ |
0.43 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 1999
|
|
|
71 |
|
|
|
0.43 |
|
|
Granted
|
|
|
187 |
|
|
|
1.36 |
|
|
Canceled
|
|
|
(29 |
) |
|
|
2.34 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2000
|
|
|
229 |
|
|
|
1.15 |
|
|
Granted
|
|
|
94 |
|
|
|
1.53 |
|
|
Canceled
|
|
|
(6 |
) |
|
|
0.64 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2001
|
|
|
317 |
|
|
|
1.28 |
|
|
Granted
|
|
|
11 |
|
|
|
1.49 |
|
|
Canceled
|
|
|
(8 |
) |
|
|
1.40 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2002
|
|
|
320 |
|
|
|
1.28 |
|
|
Granted
|
|
|
118 |
|
|
|
6.38 |
|
|
Exercised
|
|
|
(18 |
) |
|
|
0.43 |
|
|
Canceled
|
|
|
(46 |
) |
|
|
6.38 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2003
|
|
|
374 |
|
|
|
2.30 |
|
|
Granted
|
|
|
391 |
|
|
|
4.25 |
|
|
Exercised
|
|
|
(14 |
) |
|
|
2.04 |
|
|
Canceled
|
|
|
(191 |
) |
|
|
2.34 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2004
|
|
|
560 |
|
|
|
3.57 |
|
|
Granted
|
|
|
611 |
|
|
|
5.31 |
|
|
Exercised
|
|
|
(6 |
) |
|
|
4.25 |
|
|
Canceled
|
|
|
(16 |
) |
|
|
5.31 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2005
|
|
|
1,149 |
|
|
|
4.46 |
|
|
Granted (unaudited)
|
|
|
293 |
|
|
|
5.31 |
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
Canceled (unaudited)
|
|
|
(52 |
) |
|
|
4.55 |
|
|
|
|
|
|
|
|
Outstanding, March 31, 2006 (unaudited)
|
|
|
1,390 |
|
|
|
4.63 |
|
|
Granted (unaudited)
|
|
|
692 |
|
|
|
7.86 |
|
|
Exercised (unaudited)
|
|
|
(57 |
) |
|
|
4.51 |
|
|
Canceled (unaudited)
|
|
|
(20 |
) |
|
|
5.31 |
|
|
|
|
|
|
|
|
Outstanding, June 30, 2006 (unaudited)
|
|
|
2,005 |
|
|
|
5.74 |
|
|
Exercised (unaudited)
|
|
|
(6 |
) |
|
|
5.31 |
|
|
Canceled (unaudited)
|
|
|
(130 |
) |
|
|
4.46 |
|
|
|
|
|
|
|
|
Outstanding, September 30, 2006 (unaudited)
|
|
|
1,869 |
|
|
|
5.85 |
|
|
Exercised (unaudited)
|
|
|
|
|
|
|
|
|
|
Canceled (unaudited)
|
|
|
(121 |
) |
|
|
6.30 |
|
|
|
|
|
|
|
|
Outstanding, November 7, 2006 (unaudited)
|
|
|
1,748 |
|
|
|
5.85 |
|
|
Granted (unaudited)
|
|
|
335 |
|
|
|
10.63 |
|
|
|
|
|
|
|
|
Outstanding, November 27, 2006
|
|
|
2,083 |
|
|
|
6.59 |
|
|
|
|
|
|
|
|
F-28
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Stock Option Plans (continued)
The following table summarizes information about options
outstanding at December 31, 2005 under the 2000 and 2001
Plans and outside the Plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
Options Exercisable | |
| |
|
| |
|
|
Weighted- |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Remaining |
|
Weighted- | |
|
|
|
Weighted- | |
Grant Exercise | |
|
Number | |
|
Contractual |
|
Average | |
|
Number | |
|
Average | |
Price | |
|
Outstanding | |
|
Life |
|
Exercise Price | |
|
Exercisable | |
|
Exercise Price | |
| |
|
| |
|
|
|
| |
|
| |
|
| |
|
$0.43 - $0.64 |
|
|
|
29,880 |
|
|
4.0 years |
|
$ |
0.51 |
|
|
|
27,308 |
|
|
$ |
0.51 |
|
|
$1.49 - $2.34 |
|
|
|
131,764 |
|
|
5.7 years |
|
|
1.66 |
|
|
|
116,800 |
|
|
|
1.62 |
|
|
$4.25 - $6.38 |
|
|
|
987,352 |
|
|
9.3 years |
|
|
4.97 |
|
|
|
199,339 |
|
|
|
4.76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,148,996 |
|
|
8.7 years |
|
|
4.46 |
|
|
|
343,447 |
|
|
|
3.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
In February and May 2000, the Company issued in aggregate 16,666
fully vested warrants to purchase common stock at an exercise
price of $6.38 per share in connection with services
provided to obtain financing. The warrants expire ten years from
the date of grant. The value of the warrants was estimated using
the Black-Scholes valuation model and was not material to the
financial statements. As of September 30, 2006, 12,745
warrants to purchase common stock have been exercised.
In June 2003, the Company issued a warrant to
purchase 6,471 fully vested shares of common stock to a
member of the Board of Directors at an exercise price of
$5.40 per share in connection with services provided to
facilitate the acquisition of certain worldwide patents and
patent rights. The warrant expires in June 2014. The value of
the warrant was estimated using the Black-Scholes valuation
model and $34,000 was capitalized as intellectual property in
the December 31, 2004 balance sheet and is being amortized
over six years. The following assumptions were utilized in the
model: expected dividend yield of 0%, expected volatility of
75%, risk-free interest rate of 4%, and contractual life of ten
years. As of September 30, 2006, no warrants have been
exercised.
In connection with the 2002 Notes, the Company issued 1,125,505
and 1,489,495 warrants to purchase Series C-1 preferred
stock to the holders of the 2002 Notes during the years ended
December 31, 2002 and 2003, respectively. The warrants are
fully vested and have an exercise price of $1.00. The proceeds
from the 2002 Notes were allocated to the carrying values of the
notes and the warrants on the basis of their relative fair
values at the date of issuance. The fair value of the warrants
was calculated using the Black-Scholes option pricing model with
the following assumptions: expected dividend yield of 0%,
expected volatility of 75%, risk-free interest rate of 3%, and
contractual life of five years. As the fair value of the
warrants exceeded the carrying value of the 2002 Notes, the
allocated discount related to the warrants was limited to the
amount of the proceeds from the 2002 Notes. As a result,
$1,126,000 and $1,489,000 was recorded as a debt discount in
2002 and 2003, respectively. The discount was amortized over the
term the 2002 Notes were outstanding, which resulted in interest
expense of $745,000 and $1,870,000 in the years ended
December 31, 2002 and 2003, respectively. The discount was
fully amortized at December 31, 2003, as the 2002 Notes had
been converted to Series C-1 preferred stock. As of
September 30, 2006, 50,000 warrants have been exercised.
F-29
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Warrants (continued)
In connection with the 2004 Notes, the Company issued warrants
to purchase 634,016 shares of common stock to the
holders of the 2004 Notes during the year ended
December 31, 2004. The warrants are fully vested and have
an exercise price of $5.31. The proceeds from the 2004 Notes
were allocated to the carrying values of the notes and the
warrants on the basis of their relative fair values on the date
of issuance. Due to the value ascribed to the warrants, the
Company also recorded a beneficial conversion equal to the value
ascribed to the warrants. The fair value of the warrants was
calculated using the Black-Scholes option pricing model with the
following assumptions: expected dividend yield of 0%, expected
volatility of 75%, risk free interest of 3%, and contractual
life of five years. As a result, $5,335,000 was recorded as a
debt discount in 2004. The debt discount is being amortized over
the period during which the 2004 Notes are outstanding, which
resulted in interest expense of $3,555,000 and $1,780,000 in the
years ended December 31, 2004 and 2005, respectively. As of
September 30, 2006, warrants to purchase 2,823 shares
of common stock have been exercised.
In 2004, the Company issued a warrant to a member of the Board
of Directors to purchase 152,941 shares of common
stock at an exercise price of $5.31 per share. The warrant
expires in 2009. 117,647 of the warrant shares were immediately
vested and the remaining 35,294 warrant shares vest at
735 shares per month and the warrant shares vest earlier if
the Company receives final marketing approval for ArteFill. The
value ascribed to the 117,647 warrant shares was estimated using
the Black-Scholes valuation model and resulted in $495,000
expensed to compensation for the year ended December 31,
2004. The 35,294 warrants were deemed to be employee warrants.
As these warrants were issued with an exercise price less than
the deemed fair market value of the underlying shares at grant
date, the Company recorded the intrinsic value of $38,000 as
deferred compensation and is amortizing to compensation expense
over the term of the vesting period.
In September and November 2004, the Company issued in aggregate
100,000 fully vested warrants to purchase common stock at
exercise prices ranging from $4.25 to $8.50 per share in
connection with various consulting services provided to the
Company. The warrants expire from four to ten years from the
date of grant. The value of the warrants was estimated using the
Black-Scholes valuation model and resulted in $417,000 expensed
to compensation for the year ended December 31, 2004. As of
September 30, 2006, no warrants have been exercised.
In September 2004, the Company issued 17,343 fully vested
warrants to purchase common stock at exercise prices of $5.31
and $10.63 per share in lieu of interest on an outstanding
accounts payable balance. The warrants expire in five years. The
value of the warrants was estimated using the Black-Scholes
valuation model and resulted in $72,000 expensed to interest for
the year ended December 31, 2004. In connection with a
settlement agreement in October 2005 these warrants were
canceled.
In November 2004, the Company issued 8,235 fully vested warrants
to purchase common stock at an exercise price of $8.50 in
connection with Series D subscriptions as direct financing
related costs. There was no net impact to the consolidated
financial statements. The warrants expire November 22, 2009
and as of September 30, 2006, no warrants have been
exercised.
In September 2004, the Company issued 23,528 fully paid warrants
to purchase common stock in connection with services provided by
an employee to the Company. The warrants were to vest monthly in
an equal amount over a
12-month period. The
Company recorded $100,000 of compensation expense in 2004 based
on the fair value of the warrants as the warrants vested. On
December 31, 2004, 7,843 warrants were cancelled due to
termination of services. On May 17, 2005, the 15,685 vested
warrants were exercised.
F-30
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Warrants (continued)
In connection with the 2005 Bridge Loans, in 2005 the Company
issued warrants equal to 30% of the principal amount of the
Notes divided by the exercise price of $2.00 per share or
warrants to purchase 1,045,500 shares of Series D
convertible preferred stock. The warrants may be exercised any
time for a period of five years. The proceeds from the 2005
Bridge Loan were allocated to the carrying values of the notes
and the warrants on the basis of their relative fair values on
the date of issuance. Due to the value ascribed to the warrants,
the Company also recorded a beneficial conversion equal to the
value ascribed to the warrants. The fair value of the warrants
was calculated using the Black-Scholes option pricing model with
the following assumptions: expected dividend yield of 0%,
expected volatility of 75%, risk free interest of 3.0%, and
contractual life of five years. As a result, $2,007,360 was
recorded as a debt discount in 2005 and $1,772,000 was amortized
in 2005. As of September 30, 2006, no warrants have been
exercised.
In 2005, certain purchasers of Series D convertible
preferred stock received a warrant to purchase one share of
common stock for each five shares of Series D convertible
preferred stock purchased, or 198,310 warrants to purchase
common stock at an exercise price of $8.50 per share. The
warrants vest immediately and may be exercised any time for a
period of five years. The fair value of the warrants was
calculated using the Black-Scholes option pricing model with the
following assumptions: expected dividend yield of 0%, expected
volatility of 75%, risk free interest of 3.0%, and contractual
life of five years. As a result, $809,000 was recorded as equity
issuance costs in 2005 with no net impact on the financial
statements. As of September 30, 2006, no warrants have been
exercised.
On December 22, 2005, the Company issued warrants to
purchase up to 200,000 shares of Series E convertible
preferred stock at $2.50 per share. These warrants were
issued pursuant to a settlement agreement. The warrants vest
immediately and may be exercised any time for a period of seven
years. The fair value of the warrants was calculated using the
Black-Scholes option pricing model with the following
assumptions: expected dividend yield of 0%, expected volatility
of 75%, risk free interest of 4.5%, and contractual life of
seven years. As a result, $364,000 was recorded as stock-based
compensation. As of September 30, 2006, no warrants have
been exercised.
On December 22, 2005, the Company issued warrants to
purchase up to 4,543 shares of common stock at
$5.31 per share. These warrants were issued pursuant to a
settlement agreement. The warrants vest immediately and may be
exercised any time for a period of five years. The fair value of
the warrants was calculated using the Black-Scholes option
pricing model with the following assumptions: expected dividend
yield of 0%, expected volatility of 75%, risk free interest of
4.5%, and contractual life of five years. As a result, $35,000
was recorded as stock-based compensation. As of
September 30, 2006, no warrants have been exercised.
On December 30, 2005, the Company entered into an amendment
of the 2005 Bridge Loan with an investor (See Note 6). In
connection with the amendment, the Company issued warrant to a
member of the Board of Directors to
purchase 35,294 shares of common stock at an exercise
price of $5.31 per share. The warrant expires in 2010 all
of the warrant shares were immediately vested. The value
ascribed to the 35,294 warrant shares was estimated using the
Black-Scholes valuation model and resulted in $276,000
capitalized as deferred financing costs at December 31,
2005. The deferred financing costs will be expensed as
additional interest over the period in which the loan will be
repaid under the amendment.
F-31
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Warrants (continued)
The following table summarizes common and preferred stock
warrant activity from August 24, 1999
(inception) through November 27, 2006, on an as-if
converted to common stock basis:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average | |
|
|
Warrants | |
|
Exercise Price | |
|
|
| |
|
| |
Outstanding, August 24, 1999 (inception)
|
|
|
|
|
|
|
|
|
|
Issued
|
|
|
16,666 |
|
|
$ |
6.37 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2000
|
|
|
16,666 |
|
|
|
6.37 |
|
Outstanding, December 31, 2001
|
|
|
16,666 |
|
|
|
6.37 |
|
|
Issued
|
|
|
846,029 |
|
|
|
4.25 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2002
|
|
|
862,695 |
|
|
|
3.02 |
|
|
Issued
|
|
|
6,471 |
|
|
|
5.40 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2003
|
|
|
869,166 |
|
|
|
3.02 |
|
|
Issued
|
|
|
928,223 |
|
|
|
5.31 |
|
|
Exercised
|
|
|
(471 |
) |
|
|
5.31 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2004
|
|
|
1,796,918 |
|
|
|
4.21 |
|
|
Issued
|
|
|
684,111 |
|
|
|
7.61 |
|
|
Expired
|
|
|
(16,666 |
) |
|
|
6.37 |
|
|
Cancelled
|
|
|
(17,343 |
) |
|
|
5.82 |
|
|
Exercised
|
|
|
(23,261 |
) |
|
|
6.33 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2005
|
|
|
2,423,759 |
|
|
|
5.10 |
|
|
Issued (unaudited)
|
|
|
951,145 |
|
|
|
10.11 |
|
|
Exercised (unaudited)
|
|
|
(12,745 |
) |
|
|
6.37 |
|
|
|
|
|
|
|
|
Outstanding, March 31, 2006 (unaudited)
|
|
|
3,362,159 |
|
|
|
6.59 |
|
|
Exercised (unaudited)
|
|
|
(18,529 |
) |
|
|
3.36 |
|
|
|
|
|
|
|
|
Outstanding, June 30, 2006 (unaudited)
|
|
|
3,343,630 |
|
|
|
6.59 |
|
|
Issued (unaudited)
|
|
|
26,070 |
|
|
|
4.25 |
|
|
Cancelled (unaudited)
|
|
|
(4,166 |
) |
|
|
5.31 |
|
|
|
|
|
|
|
|
Outstanding, September 30, 2006 (unaudited)
|
|
|
3,365,534 |
|
|
|
6.59 |
|
|
Cancelled (unaudited)
|
|
|
(1,715 |
) |
|
|
5.31 |
|
|
|
|
|
|
|
|
Outstanding, November 7, 2006 (unaudited)
|
|
|
3,364,037 |
|
|
|
6.59 |
|
|
Granted (unaudited)
|
|
|
28,235 |
|
|
|
10.63 |
|
|
|
|
|
|
|
|
Outstanding, November 27, 2006 (unaudited)
|
|
|
3,392,272 |
|
|
|
6.62 |
|
|
|
|
|
|
|
|
F-32
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
7. |
Stockholders Equity (Deficit) (continued) |
Common Shares Reserved for Issuance
The following table summarizes common shares reserved for future
issuance on exercise or conversion of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
September 30, | |
|
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
|
|
|
(unaudited) | |
Convertible preferred stock as adjusted for anti-dilution
provisions in conjunction with Series C-1 shares issued
|
|
|
5,307,180 |
|
|
|
9,367,511 |
|
Warrants for common and preferred stock
|
|
|
2,423,758 |
|
|
|
3,365,534 |
|
Common stock options outstanding previous to 2001 Plan
|
|
|
58,117 |
|
|
|
55,760 |
|
Common stock options outstanding under 2001 Plan
|
|
|
1,090,880 |
|
|
|
1,813,916 |
|
Common stock options available for future grant
|
|
|
1,256,176 |
|
|
|
472,558 |
|
|
|
|
|
|
|
|
Total common shares reserved for issuance
|
|
|
10,136,111 |
|
|
|
15,075,279 |
|
|
|
|
|
|
|
|
At December 31, 2005, the Company had federal and
California tax net operating loss carryforwards of approximately
$43,044,000 and $43,034,000, respectively. The federal and state
tax loss carryforwards begin to expire in 2019 and 2009,
respectively, unless previously utilized.
Pursuant to Internal Revenue Code Sections 382 and 383, use
of the Companys net operating loss and tax credit
carryforwards may be subject to an annual limitation if
cumulative changes in ownership of more than 50% occur within a
three-year period.
Significant components of the Companys deferred tax assets
are shown below. A valuation allowance has been established to
offset the U.S. deferred tax assets, as realization of such
assets has not met the more likely than not threshold required
under SFAS No. 109.
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
|
(in thousands) | |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
$ |
9,977 |
|
|
$ |
17,146 |
|
|
Reserves and other
|
|
|
1,182 |
|
|
|
2,200 |
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
11,159 |
|
|
|
19,346 |
|
Valuation allowance for deferred tax assets
|
|
|
(11,144 |
) |
|
|
(19,346 |
) |
|
|
|
|
|
|
|
|
|
|
15 |
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
|
Foreign intangible
|
|
|
(2,341 |
) |
|
|
(1,831 |
) |
|
Other
|
|
|
(15 |
) |
|
|
(15 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities
|
|
|
(2,356 |
) |
|
|
(1,846 |
) |
|
|
|
|
|
|
|
Net deferred tax liabilities
|
|
$ |
(2,341 |
) |
|
$ |
(1,846 |
) |
|
|
|
|
|
|
|
F-33
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
8. |
Income Taxes (continued) |
The components of the benefit (expense) for income taxes are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2003 |
|
2004 | |
|
2005 | |
|
|
|
|
| |
|
| |
Current:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
State
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
|
|
|
|
|
|
|
(43 |
) |
|
|
(37 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(43 |
) |
|
|
(37 |
) |
Deferred:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
State
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
|
|
|
|
|
|
|
497 |
|
|
|
495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
497 |
|
|
|
495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
454 |
|
|
$ |
458 |
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of the statutory federal income tax benefit to
the Companys effective tax benefit (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
Tax benefit at federal statutory rate
|
|
$ |
2,081 |
|
|
$ |
4,365 |
|
|
$ |
7,718 |
|
State, net of federal benefit
|
|
|
357 |
|
|
|
749 |
|
|
|
1,324 |
|
Foreign tax
|
|
|
|
|
|
|
454 |
|
|
|
458 |
|
Change in valuation allowance excluding change applicable to
purchased intangibles
|
|
|
(2,435 |
) |
|
|
(4,034 |
) |
|
|
(8,202 |
) |
Change in valuation allowance applicable to purchased intangibles
|
|
|
|
|
|
|
84 |
|
|
|
5 |
|
Other foreign loss
|
|
|
|
|
|
|
(452 |
) |
|
|
(457 |
) |
Other permanent differences
|
|
|
(3 |
) |
|
|
(712 |
) |
|
|
(388 |
) |
|
|
|
|
|
|
|
|
|
|
Benefit for income taxes
|
|
$ |
|
|
|
$ |
454 |
|
|
$ |
458 |
|
|
|
|
|
|
|
|
|
|
|
Effective January 1, 2000, the Company adopted a defined
contribution 401(k) profit sharing plan (the
Plan) covering substantially all employees that meet
certain age requirements. Employees may contribute up to 100% of
their compensation per year (subject to a maximum limit by
federal law). The Plan does allow for employer matching. To
date, no employer match has been made.
|
|
10. |
Related-Party Transactions |
The Company receives services from entities affiliated with
stockholders of the Company. The Company paid $318,000, $0, $0,
$0, $0 and $389,000 during the years ended December 31,
2003, 2004, 2005, and for the nine months ended
September 30, 2005 and 2006 and for the period from
August 24, 1999 (inception) through September 30,
2006, respectively, for those services.
F-34
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
10. |
Related-Party Transactions (continued) |
During the year ended December 31, 2005, the Company paid
$2,250,000 in payments to a related party under the Mediplant
purchase agreement (see Note 3).
On December 30, 2005, the Company entered into an amendment
of the 2005 Bridge Loan with an investor (see Note 6). Per
the note amendment, the investor waived both its conversion and
redemption options under the original note and extended the due
date of the remaining outstanding principal. Three Company
directors personally guaranteed the remaining outstanding
principal under the amended note agreement. In exchange for the
personal guarantees, the three Company directors were given
23,529 shares of common stock. At December 31, 2005,
the common stock had not yet been issued and is included as
common stock issuable in the 2005 consolidated balance sheet and
the consolidated statement of shareholders equity
(deficit). On January 3, 2006, the common shares were
issued.
In January 2006, the Companys stockholders approved the
filing of two amendments to the Companys Fifth Amended and
Restated Certificate of Incorporation that would allow the
Company to complete an additional financing transaction
(Series E Financing). One amendment provides
for an increase in the authorized shares of Series E
convertible preferred stock from 10,000,000 shares to
25,000,000 shares, and a corresponding increase in the
number of total authorized shares of Preferred Stock for all
designations. The second amendment provides for certain changes
in voting rights, whereby (a) the holders of Preferred
Stock (voting together as a single class on an as-converted to
Common Stock basis) shall be entitled to elect one
(1) member of the Board of Directors, (b) the holders
of Common Stock (voting as a separate class) shall be entitled
to elect one (1) member of the Board of Directors and
(c) the holders of Common Stock and Preferred Stock (voting
together as a single class on an as-converted basis), shall be
entitled to elect all remaining members of the Board of
Directors. In addition, the shareholders approved the proposed
terms and conditions of the Series E Financing for which
the first round had closed on December 22, 2005 (see
Note 7).
In March 2006, the Company entered into a separation agreement
with a founder in connection with his retirement and
resignation. Under the terms of the agreement, the Company
agreed to pay a cash bonus of $70,000 for his performance during
fiscal year 2005 and to retain him as a consultant for an
initial term of up to 24 months beginning March 15,
2006, subject to an extension for an additional 12 months under
certain circumstances. In connection with the separation
agreement, the parties also entered into a voting agreement,
pursuant to which the founder agreed to vote all shares of
voting capital stock owned by him as directed by a majority of
the board of directors on all matters presented for a vote of
the stockholders. In May 2006, the Company terminated the
consulting arrangement as permitted under the terms of the
separation agreement and the Company paid a lump sum payment of
$366,667, the amount to which the founder would have been
entitled had he completed the initial term of the separation
agreement.
In May 2006, the Company paid $500,000 to Stifel, Nicolaus &
Company, Incorporated in connection with a settlement agreement.
On June 9, 2006, the Company granted 132,941 options to
purchase common stock to employees at a weighted average
exercise price of $7.86 per share. These options vest over
a four a year term with a six-month cliff. The grant-date fair
value of the underlying common stock was $12.75 per share.
For purposes of calculating the stock-based compensation expense
to be recognized under SFAS No. 123R, the Company
valued these employee stock options using the Black-Scholes
option pricing model with the following assumptions: an expected
term of 5.96 years; expected volatility of 60%; a risk free
interest rate of 4.55%; and a dividend yield of 0%. Stock-based
compensation related to these stock options was $1,186,500 and
will be recognized over a weighted average requisite service
period of approximately four years.
F-35
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
11. |
Subsequent Events (continued) |
On June 30, 2006, the Company granted 558,823 options to
purchase common stock to employees at a weighted-average
exercise price of $7.86 per share. These options vest over a
four-year term. The grant-date fair value of the underlying
common stock was $12.75 per share. For the purposes of
calculating the stock-based compensation expense to be
recognized under SFAS No. 123R, the Company valued
these employee stock options using the Black-Scholes option
pricing model with the following assumptions; expected
volatility of 60%; a risk free interest rate of 4.55%; and a
dividend yield of 0%. Stock-based compensation related to these
stock options was $4,987,500 and will be recognized over a
weighted average requisite service period of approximately four
years.
In June 2006, the Company offered certain holders of warrants
that were issued in exchange for services an opportunity to
amend their warrant agreements to eliminate the automatic
expiration upon the closing date of the Companys initial
public offering if not exercised prior, and to allow the
warrants to continue in effect under the amended agreement until
March 15, 2007. In return, the warrant holders agreed to
eliminate their ability to do cashless exercises of their
warrants.
In June 2006, the Company also offered certain holders of
warrants that were issued in connection with bridge loans an
opportunity to amend their warrant agreements to eliminate the
automatic expiration upon the closing date of the Companys
initial public offering if not exercised prior, and to allow the
warrants to continue in effect under the term of the original
warrant agreements. In return, the warrant holders agreed to
eliminate their ability to do cashless exercises of their
warrants. The bridge loans have been either repaid or converted
to convertible preferred stock in prior periods.
In June 2006, in connection with the offer to amend the terms of
the warrant agreements, certain medical/scientific advisory
members received accelerated vesting of their unvested warrants.
In June 2006, the Company amended the warrant agreements of
certain key individuals to eliminate the automatic expiration
upon the closing date of the Companys initial public
offering if not exercised prior, and to allow the warrants to
continue in effect under the terms of the original warrant
agreements.
These offers remained open until June 23, 2006. Based on
the warrant holders preferences, the Company recorded a
warrant modification expense of $1,376,000 during the nine
months ended September 30, 2006. Of the warrant
modification expense of $1,376,000, $477,000 was recorded as
interest expense because these original warrants were issued in
connection with financings. The remaining $899,000 was recorded
as consulting expense, comprised of $66,000 in research and
development expense and $833,000 in selling, general and
administrative expense because these original warrants were
issued in exchange for services. The Company expects that
warrants to purchase 2,490,189 shares of the Companys
common stock, at a weighted average exercise price of $6.98,
will be outstanding upon completion of the Companys
initial public offering.
In October 2006, the Company made a number of changes to its
management team. At a board meeting held on October 26,
2006, the Companys board determined that it was in the
best interests of the Company and its stockholders to remove Dr.
Stefan M. Lemperle from his position as Chief Executive Officer.
In addition, on October 26, 2006, the Companys board
approved a plan to reduce the Companys operating costs and
to reorganize its business operations, including the
Companys sales and marketing organization, to focus its
efforts on the U.S. market and on physician-based training and
sales programs. In connection with this cost reduction plan and
reorganization, the Company terminated the employment of William
von Brendel, Vice President of Worldwide Sales and International
Markets, Harold T. Schreiber, Chief Creative Officer, and a
manager in the Companys sales and marketing organization.
F-36
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
|
11. |
Subsequent Events (continued) |
On October 27, 2006, the FDA approved ArteFill, the
Companys non-resorbable aesthetic injectable implant for
the correction of facial wrinkles known as smile lines, or
nasolabial folds.
On November 2, 2006, the Company received a notice of
demand for arbitration from Mr. Schreiber in connection
with the termination of his employment. While the ultimate
outcome cannot be predicted, management does not believe that
the final resolution will have a material adverse effect on the
Companys financial statements.
On November 6, 2006, the Company filed a demand for
arbitration with the American Arbitration Association against
Melvin Ehrlich, who served as the Companys President and
Chief Operating Officer from January 2004 to April 2004. The
Company is seeking declaratory relief regarding the number of
shares of common stock Mr. Ehrlich is entitled to purchase
under a warrant issued to him in connection with his employment
agreement. While the ultimate outcome cannot be predicted,
management does not believe that the final resolution will have
a material adverse effect on the Companys financial
statements.
On November 16, 2006, the Company received a notice of
demand for arbitration from Mr. Von Brendel in connection
with the termination of his employment. While the ultimate
outcome cannot be predicted, management does not believe that
the final resolution will have a material adverse effect on the
Companys financial statements.
On November 17, 2006, the Company entered into a separation
agreement and mutual general release with Dr. Stefan M.
Lemperle in connection with his resignation as a director and as
an employee. Pursuant to the agreement, the Company has paid
Dr. Stefan Lemperle a severance payment of $250,000, plus
an additional $81,250 in lieu of any bonus payments related to
fiscal years 2005 and 2006. The Company also agreed to make
severance payments to Dr. Stefan M. Lemperle in an
aggregate amount of $300,000, payable in 12 monthly
installments of $25,000 per month, commencing in December 2006,
and to provide COBRA coverage to Dr. Stefan M. Lemperle for
a period of 12 months from the date of his resignation.
Dr. Stefan M. Lemperle is eligible to receive an additional
severance payment of $400,000, contingent upon the
Companys completion of this offering or another qualifying
transaction, as defined in the agreement (including an IPO),
before March 31, 2007. In connection with the agreement,
the Company also amended the terms of the outstanding stock
options held by Dr. Stefan M. Lemperle to provide for the
full acceleration of all unvested shares under his stock
options, and the Company has agreed to issue to Dr. Stefan
M. Lemperle a warrant to purchase up to 117,647 shares of
common stock, subject to certain conditions and in an amount
determined in accordance with the terms of the agreement. In
consideration for these payments and benefits, Dr. Stefan
M. Lemperle has provided a general release of claims against the
Company and has agreed to cooperate with the Company in various
matters, including assisting the Company in responding to
questions raised by the FDA or other regulatory bodies,
facilitating the completion of the initial public offering and
assisting with the resolution of outstanding claims against the
Company by certain former employees. The impact on the financial
statements of the separation agreement with Dr. Lemperle is
estimated to range from $1,800,000 to $2,300,000.
On November 22, 2006, a 1-for-4.25 reverse stock split was
approved by the Companys Board of Directors, which was
previously approved by the Companys stockholders. The
accompanying consolidated financial statements give retroactive
effect to the reverse stock split for all periods presented.
On November 22, 2006, the Company granted 335,246 options
to purchase common stock to employees at a weighted-average
exercise price of $10.63 per share. These options vest over
a four-year term. The grant-date fair value of the underlying
common stock was $13.00 per share. For purposes of calculating
the stock-based compensation expense to be recognized under SFAS
No. 123R, the Company valued these employee
F-37
Artes Medical, Inc.
(a development stage company)
Notes to Consolidated Financial Statements (continued)
|
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11. |
Subsequent Events (continued) |
stock options using the Black-Scholes option pricing model with
the following assumptions; expected volatility of 60%; a risk
free interest rate of 4.55%; and a dividend yield of 0%.
Stock-based compensation related to these stock options was
$2,806,847 and will be recognized over a weighted average
requisite service period of approximately four years.
On November 27, 2006, the Company entered into a loan and
security agreement with Comerica Bank, pursuant to which the
Company has obtained a credit facility with Comerica Bank,
consisting of a revolving line of credit in the amount of up to
$5,000,000 and a term loan in the amount of up to $5,000,000.
Interest on the revolving line and the term loan will be at
prime plus 2%. The revolving line and term loan mature on
November 27, 2007 and 2010, respectively. The agreement
requires the Company to meet certain liquidity ratios and there
are also limitations on mergers, acquisitions and distributions.
In addition the Company granted the bank a warrant to purchase
120,000 shares of Series E preferred stock at $2.50.
The fair value of the warrant plus the related beneficial
conversion feature of $253,600, will be recorded as debt
discount and amortized over the life of the credit lines. The
debt is secured by substantially all of the assets of the
Company.
F-38
4,600,000 Shares
Common Stock
PROSPECTUS
Cowen and Company
Lazard Capital Markets
Stifel Nicolaus
December 19, 2006
Through and including January 13, 2007 (25 days after the
date of this prospectus), all dealers effecting transactions in
these securities, whether or not participating in this offering,
may be required to deliver a prospectus. This is in addition to
the dealers obligation to deliver a prospectus when acting
as underwriters and with respect to their unsold allotments or
subscriptions.