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As filed with the Securities and Exchange Commission on November 14, 2006
Registration No. 333-[ ]
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
Akorn, Inc.
(Exact name of Registrant as specified in its charter)
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Louisiana
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72-0717400 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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2500 Millbrook Drive, Buffalo Grove, Illinois 60089
(Address, including zip code, of Registrants principal executive offices)
Arthur S. Przybyl
President and Chief Executive Officer
Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove, Illinois 60089
(847) 279-6100
(Name, Address and Telephone Number of Agent for Service)
Copies to:
Kurt L. Kicklighter, Esq.
Luce, Forward, Hamilton & Scripps LLP
600 W. Broadway, Suite 2600
San Diego, California 92101
(619) 236-1414
Approximate date of commencement of proposed sale to public: As soon as practicable after the
effective date of this Registration Statement.
If the only securities being registered on this form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the following box. þ
If this form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, please check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
If this form is a registration statement pursuant to General Instruction I.D. or a post-effective
amendment thereto that shall become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box. o
If this form is a post-effective amendment to a registration statement filed pursuant to General
Instruction I.D. filed to register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the following box. o
CALCULATION OF REGISTRATION FEE
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Title Of Each Class |
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Proposed |
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Proposed |
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Of Securities To Be |
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Amount To Be |
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Maximum Offering |
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Maximum Aggregate |
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Amount Of |
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Registered |
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Registered |
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Price Per Unit |
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Offering Price |
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Registration Fee |
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Common Stock |
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1,000,000 |
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$4.35 (1) |
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$4,350,000 |
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$465.45 |
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(1) |
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Estimated solely for the purpose of calculating the registration fee, pursuant to Rule
457(c), based on the average of the high and low prices of the Registrants common stock as
reported on the American Stock Exchange for November 10, 2006, which date is within five
business days prior to the initial filing date of this Registration Statement. |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary
to delay its effective date until the Registrant shall file a further amendment which specifically
states that this Registration Statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall
become effective on such date as the Securities and Exchange Commission, acting pursuant to said
Section 8(a), may determine.
The information contained in this prospectus is not complete and may be changed. The selling
stockholder may not sell these securities pursuant to this prospectus until the registration
statement filed with the Securities and Exchange Commission is effective. This prospectus is not
an offer to sell these securities and is not soliciting an offer to buy these securities in any
state where the offer or sale is not permitted.
Prospectus dated [ ], subject to completion
PROSPECTUS
1,000,000 Shares
Akorn, Inc.
Common Stock
This prospectus relates to the resale of 1,000,000 shares of our common stock by the selling
stockholder identified in this prospectus on page 11, which have been issued to the selling
stockholder. The selling stockholder may sell the shares of common stock described in this
prospectus in public or private transactions, at prevailing market prices, or at privately
negotiated prices. The selling stockholder may sell shares directly to purchasers or through
brokers or dealers. Brokers or dealers may receive compensation in the form of discounts,
concessions or commissions from the selling stockholder. We will not receive any of the proceeds
from the sale of the shares by the selling stockholder. The selling stockholder will receive all
of the proceeds from the sale of the shares and will pay all underwriting discounts and selling
commissions, if any, applicable to the sale of the shares. We will pay the expenses of
registration of the sale of the shares. It is not possible at the present time to determine the
price to the public in any sale of the shares by the selling stockholder and the selling
stockholder reserves the right to accept or reject, in whole or in part, any proposed purchase of
shares. Accordingly, the public offering price, the amount of any applicable underwriting
discounts and commissions and the net proceeds to the selling stockholder will be determined at the
time of such sale by the selling stockholder.
Our common stock is traded on the American Stock Exchange under the symbol AKN. On November
10, 2006, the last reported sales price of our common stock was $4.45 per share.
Investing in our common stock involves risks.
See Risk Factors beginning on page 3.
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.
The date of this prospectus is [ ], 2006
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS |
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FORWARD-LOOKING STATEMENTS AND FACTORS AFFECTING FUTURE RESULTS |
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SUMMARY |
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RISK FACTORS |
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3 |
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Although our financial condition has recently improved, we have experienced operating
losses, working capital deficiencies and negative cash flows from operations on an annual
basis, and these losses and deficiencies may continue in the
future
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3 |
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We have invested significant resources in the development of lyophilization manufacturing
capability, and we may not realize the benefit of these efforts and expenditures
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3 |
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We depend on a small number of distributors, the loss of any of which could have a material adverse effect
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Our improved 2006 results reflect a single sale transaction that we do not expect to be repeated
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Certain of our directors are subject to conflicts of interest
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We may require additional capital to grow our business and such funds may not be available to us
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Our growth depends on our ability to timely develop additional pharmaceutical products
and manufacturing capabilities
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We have entered into several strategic business alliances which may not result in
marketable products
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4 |
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Our success depends on the development of generic and off-patent pharmaceutical products
which are particularly susceptible to competition, substitution policies and reimbursement
policies
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We can be subject to legal proceedings which may prove costly and time-consuming even if meritless
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Our revenues depend on sale of products manufactured by third parties, which we cannot control
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Dependence on key executive officers
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We must continue to attract and retain key personnel to be able to compete successfully
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We are subject to extensive government regulations that increase our costs and could
subject us to fines, prevent us from selling our products or prevent us from operating our
facilities
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We may implement product recalls and could be exposed to significant product liability
claims; we may have to pay significant amounts to those harmed and may suffer from adverse
publicity as a result
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The FDA may authorize sales of some prescription pharmaceuticals on a non-prescription
basis, which would reduce the profitability of our prescription products
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Our industry is very competitive. Additionally, changes in technology could render our products obsolete
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Many of the raw materials and components used in our products come from a single source
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Our patents and proprietary rights may not adequately protect our products and processes
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Concentrated ownership of our common stock and our registration of shares for public sale
creates a risk of sudden changes in our share price
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8 |
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Exercise of warrants and the conversion of preferred stock may have a substantial
dilutive effect on our common stock
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The terms of our preferred stock may reduce the value of our common stock
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Our obligations to pay dividends on our preferred stock decrease the returns available to
our common shareholders
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9 |
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We experience significant quarterly fluctuation of our results of operations, which may
increase the volatility of our stock price
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Penny Stock rules may make buying or selling our common stock difficult
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The requirements of being a public company may strain our resources and distract management
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SELLING STOCKHOLDER |
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PLAN OF DISTRIBUTION |
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11 |
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USE OF PROCEEDS |
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LEGAL MATTERS |
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EXPERTS |
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WHERE YOU CAN FIND MORE INFORMATION |
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INFORMATION INCORPORATED BY REFERENCE |
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(i)
ABOUT THIS PROSPECTUS
You should rely only on the information contained or incorporated by reference in this
prospectus and any applicable prospectus supplements. We have not authorized anyone to provide you
with different information. The selling stockholder is not offering to sell or seeking offers to
buy shares of our common stock in jurisdictions where offers and sales are prohibited. The
information contained in this prospectus is accurate only as of the date of this prospectus,
regardless of the time of delivery of this prospectus or of any sale of our common stock.
References in this prospectus to Akorn, us, we, our, or the Company refer to Akorn,
Inc. and its subsidiary, Akorn (New Jersey), Inc., as the context requires. The phrase this
prospectus refers to this prospectus and any applicable prospectus supplement and the documents
incorporated by reference in this prospectus, unless the context otherwise requires.
FORWARD-LOOKING STATEMENTS AND FACTORS AFFECTING FUTURE RESULTS
Certain statements in this prospectus constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act. When used in this prospectus, the words
anticipate, believe, could, should, propose, continue, estimate, expect, intend,
may, plan, predict, project, will and similar expressions are generally intended to
identify forward-looking statements. Any forward-looking statements, including statements
regarding our intent, belief or expectations are not guarantees of future performance. These
statements involve risks and uncertainties and actual results may differ materially from those in
the forward-looking statements as a result of various factors, including but not limited to:
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The factors described in this prospectus under the heading Risk Factors beginning
on page 3; |
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Our ability to comply with all of the requirements of the Food and Drug
Administration, including current Good Manufacturing Practices regulations; |
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Our ability to obtain regulatory approvals of, commence operations at and obtain
business for our new lyophilization facility; |
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Our ability to generate cash from operations sufficient to meet our working capital requirements; |
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The effects of federal, state and other governmental regulation on our business; |
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Our success in developing, manufacturing, acquiring and marketing new products; |
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The success of our strategic partnerships for the development and marketing of new products; |
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Our ability to bring new products to market and the effects of sales of such products on our financial results; |
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The effects of competition from generic pharmaceuticals and from other pharmaceutical companies; |
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Availability of raw materials needed to produce our products; and |
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Other factors referred to in this prospectus and our other Securities and Exchange Commission filings. |
You should read this prospectus completely with the understanding that our actual results may
differ materially from what we expect. Unless required by law, we undertake no obligation to
update publicly any forward-looking statements, whether as a result of new information, future
events or otherwise.
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SUMMARY
This summary does not contain all of the information you should consider before buying shares
in this offering. You should read this entire prospectus carefully, including Risk Factors, any
prospectus supplement and the documents incorporated by reference in this prospectus before making
an investment decision.
Company Overview
We manufacture and market diagnostic and therapeutic pharmaceuticals in specialty areas such
as ophthalmology, rheumatology, anesthesia and antidotes, among others. Our customers include
physicians, optometrists, hospitals, wholesalers, group purchasing organizations and other
pharmaceutical companies. We are a Louisiana corporation founded in 1971 in Abita Springs,
Louisiana. In 1997, we relocated our headquarters and certain operations to Illinois. We have a
wholly owned subsidiary named Akorn (New Jersey), Inc., which operates in Somerset, New Jersey and
is involved in manufacturing, product development, and administrative activities related to our
ophthalmic and injectable segments. We classify our operations into three identifiable business
segments, ophthalmic, hospital drugs & injectables and contract services.
Ophthalmic Segment. We manufacture, market and distribute a line of diagnostic and
therapeutic ophthalmic pharmaceutical products. Diagnostic products, primarily used in the office
setting, include mydriatics and cycloplegics, anesthetics, topical stains, gonioscopic solutions,
angiography dyes and others. Therapeutic products, sold primarily to wholesalers and other
national account customers, include antibiotics, anti-infectives, steroids, steroid combinations,
glaucoma medications, decongestants/antihistamines and anti-edema medications. Non-pharmaceutical
products include various artificial tear solutions, preservative-free lubricating ointments, eyelid
cleansers, vitamin supplements and contact lens accessories.
Hospital Drugs & Injectable Segment. We manufacture, market and distribute a line of
specialty drugs and injectable pharmaceuticals products, including antidotes, anesthesia, and
products used in the treatment of rheumatoid arthritis and pain management. These products are
marketed to hospitals through wholesalers and other national account customers as well as directly
to medical specialists. This segment was previously classified as the injectable segment; however,
we recently changed the classification to reflect that an increasing amount of pharmaceuticals that
we deliver to hospitals are drugs other than injectable pharmaceuticals. The new classification
reflects that this segment includes both hospital drugs and injectable pharmaceuticals.
Contract Services Segment. We manufacture products for third party pharmaceutical and
biotechnology customers based on their specifications.
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Offering Overview |
Issuer
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Akorn, Inc. |
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Address and Phone Number
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2500 Millbrook Drive Buffalo Grove, Illinois 60089 (847) 279-6100 |
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American Stock Exchange Trading Symbol
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AKN |
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Website
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www.akorn.com (information found on our website is not part of this prospectus) |
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Securities Offered
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Up to 1,000,000 (1) shares of our common stock, no par value by the
selling stockholder. |
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Use of Proceeds
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We will not receive any proceeds from the sale of shares of our common stock
covered by this prospectus. |
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Risk Factors
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In analyzing an investment in our common stock offered by this prospectus, you
should carefully consider the information set forth under Risk Factors. |
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The number of shares of common stock is subject to adjustment to prevent dilution resulting
from stock splits, stock dividends or similar events. Therefore, pursuant to Rule 416, we are also
registering such indeterminate number of shares as may be issuable in connection with stock splits,
stock dividends or similar events. The holder of the securities registered hereunder has direct
registration rights for this offering. |
We have reserved for issuance the shares of our common stock identified in this prospectus. Each
of the above listed securities which are being sold by the selling stockholder were restricted
securities under the Securities Act of 1933, or the Securities Act, prior to this registration.
The selling stockholder will determine if and when it will sell its shares and if it will sell
their shares at the current market price or at negotiated prices at the time of the sale. Although
we have agreed to pay the expenses related to the registration of the shares being offered, we will
not receive any proceeds from the sale of the shares by the selling stockholder.
2
RISK FACTORS
You should carefully consider the following risk factors and all other information contained
in this prospectus and the documents incorporated by reference in this prospectus before investing.
Investing in our common stock involves a high degree of risk. The risks and uncertainties
described below are not the only ones we face. Additional risks and uncertainties not presently
known to us or that we currently believe are immaterial also may impair our business. If any of
the events described in the following risks occur, our business, results of operations and
financial condition could be materially adversely affected. In addition, the trading price of our
common stock could decline due to any of the events described in these risks, and you may lose all
or part of your investment.
Although our financial condition has recently improved, we have experienced operating losses,
working capital deficiencies and negative cash flows from operations on an annual basis, and these
losses and deficiencies may continue in the future.
Although we have experienced recent operating income and positive cash flows for the nine
months ended September 30, 2006, we experienced operating losses, working capital deficiencies and
negative cash flows from operations on an annual basis, which may continue in the future. There
can be no assurance that our financial outlook will continue to improve as it has for the nine
months ended September 30, 2006. For the nine months ended September 30, 2006, our operating
income was $1,399,000. For the years ended December 31, 2005 and 2004, our operating losses were
$7,479,000 and $368,000, respectively. Our operating activities provided us cash flows of
$1,872,000 for the nine months ended September 30, 2006, however, we experienced negative cash
flows from operations for the years ended December 31, 2005 and 2004 of $148,000 and $3,461,000,
respectively. There can be no assurance that our results of operations will continue to improve in
the future as they have for the nine months ended September 30, 2006. If our results of operations
do not continue to improve in the future, an investment in our common stock could be negatively
affected.
We have invested significant resources in the development of lyophilization manufacturing
capability, and we may not realize the benefit of these efforts and expenditures.
We are in the process of completing an expansion of our Decatur, Illinois manufacturing
facility to add capacity to provide lyophilization manufacturing services, a manufacturing
capability we currently do not have. Manufacturing capabilities for lyophilized products are
projected to be in service by the first quarter of 2007, but are contingent on validation and
approval of the lyophilization facility by the Food and Drug Administration, or the FDA. As of
September 30, 2006, we had spent approximately $22,096,000 on the lyophilization expansion and
anticipate the need to spend approximately $300,000 of additional funds (excluding capitalized
interest) to complete the expansion, which will primarily be used for validation testing as the
major capital equipment items are currently in place. In addition, we are working toward the
development of an internal Abbreviated New Drug Applications, or ANDAs, lyophilized product
pipeline. There is no guarantee that we will be successful in completing development of
lyophilization capability, or that other intervening events will not occur that reduce or eliminate
the anticipated benefits from such capability. For instance, the market for lyophilized products
could significantly diminish or be eliminated, or new technological advances could render the
lyophilization process obsolete, prior to our entry into the market. There can be no assurance
that we will realize the anticipated benefits from our significant investment into lyophilization
capability at our Decatur manufacturing facility, and our failure to do so could significantly
limit our ability to grow our business in the future.
We depend on a small number of distributors, the loss of any of which could have a material
adverse effect.
A small number of large wholesale drug distributors account for a large portion of our gross
sales, revenues and accounts receivable. The following three distributors, AmerisourceBergen
Corporation, Cardinal Health, Inc. and McKesson Drug Company, accounted for approximately 69% of
total gross sales and 46% of total revenues in 2005, and 76% of gross trade receivables as of
December 31, 2005. These three customers accounted for approximately 78% of our gross accounts
receivable balances, for 49% of our gross revenues and 32% of our net revenues for the nine months
ended September 30, 2006. In addition to acting as distributors of our products, these three
companies also distribute a broad range of health care products for many other companies. The loss
of one or more of these distributors, together with a delay or inability to secure an alternative
distribution source for end users, could have a material negative impact on our revenue and results
of operations and lead to a violation of debt covenants. A change in purchasing patterns,
inventory levels, increases in returns of our products, delays in purchasing products and delays in
payment for products by one or more distributors also could have a material negative impact on our
revenue and results of operations.
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Our improved 2006 results reflect a single sale transaction that we do not expect to be
repeated.
Our major customer for the nine month period ended September 30, 2006 was the United States
Department of Health and Human Services, or HHS, which purchased $21,962,000 of our injectable
antidote products during the first quarter of 2006. We did not sell to HHS in 2005. We do not
anticipate additional injectable antidote sales of this magnitude now or in the future.
Certain of our directors are subject to conflicts of interest.
Dr. John N. Kapoor, Ph.D., chairman of our board of directors, our chief executive officer
from March 2001 to December 2002, and a principal shareholder, is affiliated with EJ Financial
Enterprises, Inc., a health care consulting investment company. EJ Financial is involved in the
management of health care companies in various fields, and Dr. Kapoor is involved in various
capacities with the management and operation of these companies. The John N. Kapoor Trust dated
9/20/89, or the Kapoor Trust, the beneficiary and sole trustee of which is Dr. Kapoor, is a
principal shareholder of each of these companies. As a result, Dr. Kapoor does not devote his full
time to our business. Although such companies do not currently compete directly with us, certain
companies with which EJ Financial is involved are in the pharmaceutical business. Discoveries made
by one or more of these companies could render our products less competitive or obsolete.
Potential conflicts of interest could have a material adverse effect on our business, financial
condition and results of operations.
We may require additional capital to grow our business and such funds may not be available to
us.
We may require additional funds to grow our business. However, adequate funds through the
financial markets or from other sources may not be available when needed or on terms favorable to
us due to our recent financial history. Further, the terms of such additional financing, if
obtained, likely will require the granting of rights, preferences or privileges senior to those of
our common stock and result in substantial dilution of the existing ownership interests of our
common stockholders and could include covenants and restrictions that limit our ability to operate
or expand our business in a manner that we deem to be in our best interest.
Our growth depends on our ability to timely develop additional pharmaceutical products and
manufacturing capabilities.
Our strategy for growth is dependent upon our ability to develop products that can be promoted
through current marketing and distribution channels and, when appropriate, the enhancement of such
marketing and distribution channels. We may not meet our anticipated time schedule for the filing
of ANDAs and New Drug Applications, or NDAs, or may decide not to pursue ANDAs or NDAs that we
have submitted or anticipate submitting. Our internal development of new pharmaceutical products
is dependent upon the research and development capabilities of our personnel and our strategic
business alliance infrastructure. There can be no assurance that we or our strategic business
alliances will successfully develop new pharmaceutical products or, if developed, successfully
integrate new products into our existing product lines. In addition, there can be no assurance
that we will receive all necessary FDA approvals or that such approvals will not involve delays,
which adversely affect the marketing and sale of our products. Our failure to develop new
products, to maintain substantial compliance with FDA compliance guidelines or to receive FDA
approval of ANDAs or NDAs, could have a material adverse effect on our business, financial
condition and results of operations.
We have entered into several strategic business alliances which may not result in marketable
products.
We have entered several strategic business alliances that have been formed to supply us with
low cost finished dosage form products. Since 2004, we have entered into various purchase and
supply agreements, license agreements, and a joint venture that are all designed to provide
finished dosage form products that can be marketed through our distribution pipeline. However,
there can be no assurance that any of these agreements will result in FDA-approved ANDAs or NDAs,
or that we will be able to market any such finished dosage form products at a profit. In addition,
any clinical trial expenses that we incur may result in adverse financial consequences to our
business.
Our success depends on the development of generic and off-patent pharmaceutical products which
are particularly susceptible to competition, substitution policies and reimbursement policies.
Our success depends, in part, on our ability to anticipate which branded pharmaceuticals are
about to come off patent and thus permit us to develop, manufacture and market equivalent generic
pharmaceutical products. Generic pharmaceuticals must meet the same quality standards as branded
pharmaceuticals, even though these equivalent pharmaceuticals are sold at prices that are
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significantly lower than those of branded pharmaceuticals. Generic substitution is regulated
by the federal and state governments, as is reimbursement for generic drug dispensing. There can
be no assurance that substitution will be permitted for newly approved generic drugs or that such
products will be subject to government reimbursement. In addition, generic products that third
parties develop may render our generic products noncompetitive or obsolete. There can be no
assurance that we will be able to consistently bring generic pharmaceutical products to market
quickly and efficiently in the future. An increase in competition in the sale of generic
pharmaceutical products or our failure to bring such products to market before our competitors
could have a material adverse effect on our business, financial condition and results of
operations.
Further, there is no proprietary protection for most of the branded pharmaceutical products
that either we or other pharmaceutical companies sell. In addition, governmental and
cost-containment pressures regarding the dispensing of generic equivalents will likely result in
generic substitution and competition generally for our branded pharmaceutical products. We attempt
to mitigate the effect of this substitution through, among other things, creation of strong
brand-name recognition and product-line extensions for our branded pharmaceutical products, but
there can be no assurance that we will be successful in these efforts.
We can be subject to legal proceedings which may prove costly and time-consuming even if
meritless.
In the ordinary course of our business, we can be involved in legal actions with both private
parties and certain government agencies. To the extent that our personnel may have to spend time
and resources to pursue or contest any matters that may be asserted from time to time in the
future, this represents time and money that is not available for other activities that we might
otherwise pursue which could be beneficial to our future. In addition, to the extent that we are
unsuccessful in any legal proceedings, the consequences could have a negative impact on our
business, financial condition and results of operations.
Our revenues depend on sale of products manufactured by third parties, which we cannot
control.
We derive a significant portion of our revenues from the sale of products manufactured by
third parties. There can be no assurance that our dependence on third parties for the manufacture
of such products will not adversely affect our profit margins or our ability to develop and deliver
our products on a timely and competitive basis. If for any reason we are unable to obtain or
retain third-party manufacturers on commercially acceptable terms, we may not be able to distribute
certain of our products as planned. No assurance can be made that the manufacturers we use will be
able to provide us with sufficient quantities of our products or that the products supplied to us
will meet our specifications. Any delays or difficulties with third-party manufacturers could
adversely affect the marketing and distribution of certain of our products, which could have a
material adverse effect on our business, financial condition and results of operations.
Dependence on key executive officers.
Our success will depend, in part, on our ability to attract and retain key executive officers.
We are particularly dependent upon Dr. John N. Kapoor, Ph.D., chairman of our board of directors,
and Mr. Arthur S. Przybyl, our chief executive officer. The inability to attract and retain key
executive officers, or the loss of one or more of our key executive officers could have a material
adverse effect on our business, financial condition and results of operations.
We must continue to attract and retain key personnel to be able to compete successfully.
Our performance depends, to a large extent, on the continued service of our key research and
development personnel, other technical employees, managers and sales personnel and our ability to
continue to attract and retain such personnel. Competition for such personnel is intense,
particularly for highly motivated and experienced research and development and other technical
personnel. We are facing increasing competition from companies with greater financial resources
for such personnel. There can be no assurance that we will be able to attract and retain
sufficient numbers of highly skilled personnel in the future, and the inability to do so could have
a material adverse effect on our business, operating results and financial condition and results of
operations.
We are subject to extensive government regulations that increase our costs and could subject
us to fines, prevent us from selling our products or prevent us from operating our facilities.
Federal and state government agencies regulate virtually all aspects of our business. The
development, testing, manufacturing, processing, quality, safety, efficacy, packaging, labeling,
record keeping, distribution, storage and advertising of our products, and disposal of waste
products arising from such activities, are subject to regulation by the FDA, Drug Enforcement
5
Administration, or DEA, the Consumer Product Safety Commission, the Occupational Safety and
Health Administration and the Environmental Protection Agency. Similar state and local agencies
also have jurisdiction over these activities. Noncompliance with applicable United States
regulatory requirements can result in fines, injunctions, penalties, mandatory recalls or seizures,
suspensions of production, recommendations by the FDA against governmental contracts and criminal
prosecution. Any of these could have a material adverse effect on our business, financial
condition and results of operations. New, modified and additional regulations, statutes or legal
interpretation, if any, could, among other things, require changes to manufacturing methods,
expanded or different labeling, the recall, replacement or discontinuation of certain products,
additional record keeping and expanded documentation of the properties of certain products and
scientific substantiation. Such changes or new legislation could have a material adverse effect on
our business, financial condition and results of operations.
FDA regulations. All pharmaceutical manufacturers, including us, are subject to regulation by
the FDA under the authority of the federal Food, Drug and Cosmetic Act Act, or the FDC Act.
Under the FDC Act, the federal government has extensive administrative and judicial enforcement
powers over the activities of pharmaceutical manufacturers to ensure compliance with FDA
regulations. Those powers include, but are not limited to, the authority to initiate court action
to seize unapproved or non-complying products, to enjoin non-complying activities, to halt
manufacturing operations that are not in compliance with current Good Manufacturing Practices, or
cGMP, to recall products, to seek civil and monetary penalties and to criminally prosecute
violators. Other enforcement activities include refusal to approve product applications or the
withdrawal of previously approved applications. Any such enforcement activities, including the
restriction or prohibition on sales of products we market or the halting of our manufacturing
operations, could have a material adverse effect on our business, financial condition and results
of operations. In addition, product recalls may be issued at our discretion, or at the request of
the FDA or other government agencies having regulatory authority for pharmaceutical products.
Recalls may occur due to disputed labeling claims, manufacturing issues, quality defects or other
reasons. No assurance can be given that restriction or prohibition on sales, halting of
manufacturing operations or recalls of our pharmaceutical products will not occur in the future.
Any such actions could have a material adverse effect on our business, financial condition and
results of operations. Further, such actions, in certain circumstances, could constitute an event
of default under the terms of our various financing relationships.
We must obtain approval from the FDA for each pharmaceutical product that we market. The FDA
approval process is typically lengthy and expensive, and approval is never certain. Our new
products could take a significantly longer time than we expect to gain regulatory approval and may
never gain approval. Even if the FDA or another regulatory agency approves a product, the approval
may limit the indicated uses for a product, may otherwise limit our ability to promote, sell and
distribute a product or may require post-marketing studies or impose other post-marketing
obligations.
We and our third-party manufacturers are subject to periodic inspection by the FDA to assure
regulatory compliance regarding the manufacturing, distribution, and promotion of sterile
pharmaceutical products. The FDA imposes stringent mandatory requirements on the manufacture and
distribution of sterile pharmaceutical products to ensure their sterility. The FDA also regulates
drug labeling and the advertising of prescription drugs. A finding by a governmental agency or
court that we are not in compliance with FDA requirements could have a material adverse effect on
our business, financial condition and results of operations.
We were previously subject to an FDA Warning Letter which the FDA issued to us in October 2000
following a routine inspection of our Decatur manufacturing facility. An FDA Warning Letter is
intended to provide notice to a company of violations of the laws administered by the FDA and to
elicit voluntary corrective action. The Warning Letter cited violations of regulatory requirements
identified during the 2000 inspection and requested that we take corrective actions. Under the
terms of the Warning Letter, we were unable to obtain any approvals to market new products and
government agencies were notified of our non-compliant status. Additional FDA inspections in 2002,
2003 and 2004 identified additional and recurring violations resulting in continuance of the
Warning Letter. During this time, the FDA initiated no enforcement action.
Since 2000, and in response to the violations cited by the FDA, we implemented a comprehensive
systematic corrective action plan at our Decatur manufacturing facility. We maintained regular
communications with the FDA and provided periodic progress reports.
On December 13, 2005, the FDA notified us that we had satisfactorily implemented corrective
actions and that the FDA had determined that our Decatur manufacturing facility was in substantial
compliance with cGMP regulations. Consequently, the restrictions of the 2000 Warning Letter were
removed and we became eligible for new product approvals for products manufactured at our Decatur
manufacturing facility.
6
If the FDA changes its regulatory position, it could force us to delay or suspend
indefinitely, our manufacturing, distribution or sales of certain products. While we believe that
all of our current pharmaceuticals are lawfully marketed in the United States under current FDA
enforcement policies or have received the requisite agency approvals for manufacture and sale, such
marketing authority is subject to withdrawal by the FDA. In addition, modifications or
enhancements of approved products are in many circumstances subject to additional FDA approvals
which may or may not be granted and which may be subject to a lengthy application process. Any
change in the FDAs enforcement policy or any decision by the FDA to require an approved NDA or
ANDA for one of our products not currently subject to the approved NDA or ANDA requirements or any
delay in the FDA approving an NDA or ANDA for one of our products could have a material adverse
effect on our business, financial condition and results of operations.
A number of products we market are grandfathered drugs that are permitted to be manufactured
and marketed without FDA-issued ANDAs or NDAs on the basis of their having been marketed prior to
enactment of relevant sections of the FDC Act. The regulatory status of these products is subject
to change and/or challenge by the FDA, which could establish new standards and limitations for
manufacturing and marketing such products, or challenge the evidence of prior manufacturing and
marketing upon which grandfathering status is based. We are not aware of any current efforts by
the FDA to change the status of any of our grandfathered products, but there can be no assurance
that such initiatives will not occur in the future. Any such change in the status of our
grandfathered products could have a material adverse effect on our business, financial condition
and results of operations.
We are subject to extensive DEA regulation, which could result in our being fined or otherwise
penalized. We also manufacture and sell drugs which are controlled substances as defined in the
federal Controlled Substances Act and similar state laws, which impose, among other things, certain
licensing, security and record keeping requirements administered by the DEA and similar state
agencies, as well as quotas for the manufacture, purchase and sale of controlled substances. The
DEA could limit or reduce the amount of controlled substances which we are permitted to manufacture
and market.
We may implement product recalls and could be exposed to significant product liability claims;
we may have to pay significant amounts to those harmed and may suffer from adverse publicity as a
result.
The manufacturing and marketing of pharmaceuticals involves an inherent risk that our products
may prove to be defective and cause a health risk. In that event, we may voluntarily implement a
recall or market withdrawal or may be required to do so by a regulatory authority. We have
recalled products in the past and, based on this experience, believe that the occurrence of a
recall could result in significant costs to us, potential disruptions in the supply of our products
to our customers and adverse publicity, all of which could harm our ability to market our products.
There were no product recalls in 2004, 2005 or to date in 2006. In February 2003, we recalled
two products, Fluress and Fluoracaine, due to container/closure integrity problems resulting in
leaking containers. The recall was classified by the FDA as a Class II Recall, which means that
the use of, or exposure to, a violative product may cause temporary or medically reversible adverse
health consequences or that the probability of serious health consequences as a result of such use
or exposure is remote. In March 2003, as a result of FDA inspections that occurred from December
10, 2002 to February 6, 2003, we recalled twenty-four lots of product produced from the period
December 2001 to June 2002 in one of our production rooms at our Decatur manufacturing facility.
The majority of the lots recalled were for third party contract customer products. Subsequent to
this decision and after discussions with the FDA, eight of the original twenty-four lots were
exempted from the recall due to medical necessity. The recall was classified by the FDA as a Class
II Recall.
Although we are not currently subject to any material product liability proceedings, we may
incur material liabilities relating to product liability claims in the future. Even meritless
claims could subject us to adverse publicity, hinder us from securing insurance coverage in the
future and require us to incur significant legal fees and divert the attention of the key employees
from running our business. Successful product liability claims brought against us could have a
material adverse effect on our business, financial condition and results of operations.
We currently have product liability insurance in the amount of $5,000,000 for aggregate annual
claims with a $50,000 deductible per incident and a $250,000 aggregate annual deductible. However,
there can be no assurance that such insurance coverage will be sufficient to fully cover potential
claims. Additionally, there can be no assurance that adequate insurance coverage will be available
in the future at acceptable costs, if at all, or that a product liability claim would not have a
material adverse effect on our business, financial condition and results of operations.
7
The FDA may authorize sales of some prescription pharmaceuticals on a non-prescription basis,
which would reduce the profitability of our prescription products.
From time to time, the FDA elects to permit sales of some pharmaceuticals currently sold on a
prescription basis, without a prescription. FDA approval of the sale of our products without a
prescription would reduce demand for our competing prescription products and, accordingly, reduce
our profits.
Our industry is very competitive. Additionally, changes in technology could render our
products obsolete.
We face significant competition from other pharmaceutical companies, including major
pharmaceutical companies with financial resources substantially greater than ours, in developing,
acquiring, manufacturing and marketing pharmaceutical products. The selling prices of
pharmaceutical products typically decline as competition increases. Further, other products now in
use, under development or acquired by other pharmaceutical companies, may be more effective or
offered at lower prices than our current or future products. The industry is characterized by
rapid technological change that may render our products obsolete, and competitors may develop their
products more rapidly than we can. Competitors may also be able to complete the regulatory process
sooner, and therefore, may begin to market their products in advance of our products. We believe
that competition in sales of our products is based primarily on price, service and technical
capabilities. There can be no assurance that: (i) we will be able to develop or acquire
commercially attractive pharmaceutical products; (ii) additional competitors will not enter the
market; or (iii) competition from other pharmaceutical companies will not have a material adverse
effect on our business, financial condition and results of operations.
Many of the raw materials and components used in our products come from a single source.
We require a supply of quality raw materials and components to manufacture and package
pharmaceutical products for ourselves and for third parties with which we have contracted. Many of
the raw materials and components used in our products come from a single source and interruptions
in the supply of these raw materials and components could disrupt our manufacturing of specific
products and cause our sales and profitability to decline. Further, in the case of many of our
ANDAs and NDAs, only one supplier of raw materials has been identified. Because FDA approval of
drugs requires manufacturers to specify their proposed suppliers of active ingredients and certain
packaging materials in their applications, FDA approval of any new supplier would be required if
active ingredients or such packaging materials were no longer available from the specified
supplier. The qualification of a new supplier could delay our development and marketing efforts.
If for any reason we are unable to obtain sufficient quantities of any of the raw materials or
components required to produce and package our products, we may not be able to manufacture our
products as planned, which could have a material adverse effect on our business, financial
condition and results of operations.
Our patents and proprietary rights may not adequately protect our products and processes.
The patent and proprietary rights position of competitors in the pharmaceutical industry
generally is highly uncertain, involves complex legal and factual questions, and is the subject of
much litigation. There can be no assurance that any patent applications or other proprietary
rights, including licensed rights, relating to our potential products or processes will result in
patents being issued or other proprietary rights secured, or that the resulting patents or
proprietary rights, if any, will provide protection against competitors who: (i) successfully
challenge our patents or proprietary rights; (ii) obtain patents or proprietary rights that may
have an adverse effect on our ability to conduct business; or (iii) are able to circumvent our
patent or proprietary rights position. It is possible that other parties have conducted or are
conducting research and could make discoveries of pharmaceutical formulations or processes that
would precede any discoveries made by us, which could prevent us from obtaining patent or other
protection for these discoveries or marketing products developed there from. Consequently, there
can be no assurance that others will not independently develop pharmaceutical products similar to
or obsoleting those that we are planning to develop, or duplicate any of our products. Our
inability to obtain patents for, or other proprietary rights in, our products and processes or the
ability of competitors to circumvent or obsolete our patents or proprietary rights could have a
material adverse effect on our business, financial condition and results of operations.
Concentrated ownership of our common stock and our registration of shares for public sale
creates a risk of sudden changes in our share price.
The sale by any of our large shareholders of a significant portion of that shareholders
holdings could have a material adverse effect on the market price of our common stock. We are
registering, for sale by the selling stockholder identified herein, 1,000,000 shares of our common
stock under a registration statement on Form S-3 of which this prospectus is a part. We also
previously
8
registered 5,820,757 shares of our common stock for sale by some of our securityholders under
a registration statement on From S-3 filed with the Securities and Exchange Commission, or the
SEC, and an additional 64,964,680 shares of our common stock for sale by some of our
securityholders under a registration statement on a Form S-1 and a Form S-3 filed with the SEC.
Sales of any of these shares on the open market could cause the price of our stock to decline.
Exercise of warrants and the conversion of preferred stock may have a substantial dilutive
effect on our common stock.
If the price per share of our common stock at the time of exercise or conversion of any
preferred stock, warrants, options, or any other convertible securities is in excess of the various
exercise or conversion prices of such convertible securities, exercise or conversion of such
convertible securities would have a dilutive effect on our common stock. As of September 30, 2006,
holders of our convertible securities would receive 3,115,166 shares of our common stock upon
conversion and holders of our outstanding warrants and options would receive 7,671,348 shares of
our common stock at a weighted average exercise price of $2.76 per share. The amount of such
dilution that may result from the exercise or conversion of the foregoing, however, cannot
currently be determined as it would depend on the difference between our common stock price and the
price at which such convertible securities were exercised or converted at the time of such exercise
or conversion. For example, on January 13, 2006, all 241,122 outstanding shares of our Series A
6.0% Participating Convertible Preferred Stock, or Series A Preferred Stock, were converted into
36,796,755 shares of common stock, and on March 31, 2006, the Kapoor Trust converted an aggregate
of $7,297,653 of principal and accrued interest that we owed to the Kapoor Trust into 3,540,281
shares of our common stock. Any additional financing that we secure likely will require the
granting of rights, preferences or privileges senior to those of our common stock and will result
in substantial dilution of the existing ownership interests of our common shareholders.
The terms of our preferred stock may reduce the value of our common stock.
We are authorized to issue up to a total of 5,000,000 shares of preferred stock in one or more
series. As of December 31, 2005, we had 241,122 shares of our Series A Preferred Stock
outstanding, and on January 13, 2006, all of those shares, including the related accrued and unpaid
dividends, were converted into 36,796,755 shares of common stock. As of September 30, 2006, we had
74,195 shares of our Series B 6.0% Participating Convertible Preferred Stock, or Series B
Preferred Stock, outstanding, and 4,601,828 additional shares of preferred stock remained
authorized for issuance. Our board of directors may determine whether to issue additional shares
of preferred stock and the terms of such preferred stock without further action by holders of our
common stock. If we issue additional shares of preferred stock, it could affect the rights or
reduce the value of our common stock. In particular, specific rights granted to future holders of
preferred stock could be used to restrict our ability to merge with or sell our assets to a third
party. These terms may include voting rights, preferences as to dividends and liquidation,
conversion and redemption rights, and sinking fund provisions. We continue to seek capital for the
growth of our business, and this additional capital may be raised through the issuance of
additional preferred stock.
Our obligations to pay dividends on our preferred stock decrease the returns available to our
common shareholders.
Our Series B Preferred Stock bears cumulative dividends at the rate of 6.0%. These dividends
are payable in cash, or in our discretion, in additional conversion rights. If dividends are paid
in cash, this decreases our working capital available for operations. If dividends are paid in
additional conversion rights, this results in further dilution of our common shareholders. In
either case, the equity per outstanding common share declines, which can cause a decrease in the
value of our common stock.
We experience significant quarterly fluctuation of our results of operations, which may
increase the volatility of our stock price
Our results of operations may vary from quarter to quarter due to a variety of factors
including, but not limited to, the timing of the development and marketing of new pharmaceutical
products, the failure to develop such products, delays in obtaining government approvals, including
FDA approval of NDAs or ANDAs for our products, expenditures to comply with governmental
requirements for manufacturing facilities, expenditures incurred to acquire and promote
pharmaceutical products, changes in our customer base, a customers termination of a substantial
account, the availability and cost of raw materials, interruptions in supply by third-party
manufacturers, the introduction of new products or technological innovations by our competitors,
loss of key personnel, changes in the mix of products sold by us, changes in sales and marketing
expenditures, competitive pricing pressures, expenditures incurred to pursue or contest pending or
threatened legal action and our ability to meet our financial covenants. There can be no assurance
that we will be successful in avoiding losses in any future period. Such fluctuations may result
in volatility in the price of our common stock.
9
Penny Stock rules may make buying or selling our common stock difficult.
Trading in our common stock is subject to the penny stock rules. The SEC has adopted
regulations that generally define a penny stock to be any equity security that has a market price
of less than $5.00 per share, subject to certain exceptions. These rules require that any
broker-dealer that recommends our common stock to persons other than prior customers and accredited
investors, must, prior to the sale, make a special written suitability determination for the
purchaser and receive the purchasers written agreement to execute the transaction. Unless an
exception is available, the regulations require the delivery, prior to any transaction involving a
penny stock, of a disclosure schedule explaining the penny stock market and the risks associated
with trading in the penny stock market. In addition, broker-dealers must disclose commissions
payable to both the broker-dealer and the registered representative and current quotations for the
securities they offer. The additional burdens imposed upon broker-dealers by such requirements may
discourage broker-dealers from effecting transactions in our common stock, which could severely
limit the market price and liquidity of our common stock.
The requirements of being a public company may strain our resources and distract management.
As a public company, we are subject to the reporting requirements of the Securities Exchange
Act of 1934, or the Exchange Act, and the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley
Act. These requirements are extensive. The Exchange Act requires that we file annual, quarterly
and current reports with respect to our business and financial condition. The Sarbanes-Oxley Act
requires that we maintain effective disclosure controls and procedures and internal controls for
financial reporting. In order to maintain and improve the effectiveness of our disclosure controls
and procedures and internal control over financial reporting, significant resources and management
oversight is required. This may divert managements attention from other business concerns, which
could have a material adverse effect on our business, financial condition and results of
operations.
10
SELLING STOCKHOLDER
We are registering 1,000,000 shares of our common stock for resale by the selling stockholder
named below. The term selling stockholder includes such stockholders transferees, pledgees,
donees or other successors. All of the shares we are registering were issued to a single investor
in a private placement offering pursuant to a securities purchase agreement between us and such
investor dated September 13, 2006. We are registering the 1,000,000 shares of common stock
pursuant to registration rights in the securities purchase agreement to permit the investor and its
respective transferees, pledgees, donees or other successors to resell the shares when they deem
appropriate.
The following table sets forth (1) the name of the selling stockholder; (2) the number of
shares of our common stock held by the selling stockholder that may be offered for resale pursuant
to this prospectus as of September 30, 2006; (3) the number and percentage of shares of our common
stock that the selling stockholder beneficially owns prior to the offering for resale of any of the
shares of our common stock being registered hereby as of September 30, 2006; and (4) the number and
percentage of shares of common stock to be beneficially owned by the selling stockholder after the
offering of the shares of our common stock being registered hereby, assuming all of the shares
registered hereby are sold by the selling stockholder. We will not receive any proceeds from the
resale of our common stock by the selling stockholder.
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Shares Beneficially |
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Shares Beneficially Owned |
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Owned After the |
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No. of Shares |
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Prior to the Offering (2) |
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Offering (3) |
Name |
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Offered (1) |
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Number |
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Percentage |
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Number |
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Percentage |
Serum Institute of India Limited (4) |
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1,000,000 |
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(1) |
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The number of shares included in this prospectus is subject to adjustment to prevent dilution
resulting from stock splits, stock dividends, or similar events. Therefore, pursuant to Rule
416 under the Securities Act, we are also registering such indeterminate number of shares as
may be issuable in connection with stock splits, stock dividends or similar events. |
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Includes all shares beneficially owned, whether directly or indirectly, individually or
together with associates, jointly or as community property with a spouse and shares to which
each individual has the right to acquire beneficial ownership within 60 days of September 30,
2006. |
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Percentage of shares of common stock beneficially owned after the offering is based upon
81,000,130 shares of our common stock outstanding as of September 30, 2006, plus shares of
common stock as to which the holder has the right to acquire beneficial ownership within 60
days of September 30, 2006. |
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Dr. Cyrus S. Poonawalla is the chairman and managing director of Serum Institute of India
Limited. In such capacity, Dr. Poonawalla, may be deemed to have the power to vote or to
direct the vote and to dispose or to direct the disposition of the shares beneficially owned
by Serum Institute of India Limited. |
In October 2004, we entered into an exclusive drug development and distribution agreement for
oncology drug products for the United States and Canada with Serum Institute of India Limited. We
will own the ANDAs and buy products from Serum Institute of India Limited under a negotiated
transfer price arrangement. Once the products are approved, we will market and sell them in the
United States and Canada under our label. In addition, we plan to nominate the Executive Director
of Serum Institute of India Limited, Subash Kapre, to our board of directors.
PLAN OF DISTRIBUTION
The selling stockholder, and any of its transferees, pledgees, donees, assignees or other
successors-in-interest (including successors by gift, partnership distribution or other
non-sale-related transfer effected after the date of this prospectus), may, from time to time, sell
any or all of their shares of common stock on any stock exchange, market or trading facility on
which the shares are traded or in private transactions. These sales may be at fixed prices, at
market prices at the time of sale, at varying prices determined at the time of sale or at
negotiated prices. The selling stockholder may use any one or more of the following methods when
selling shares:
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ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
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block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the
block as principal to facilitate the transaction; |
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
11
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an exchange distribution in accordance with the rules of the applicable exchange; |
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privately negotiated transactions; |
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broker-dealers may agree with the selling stockholder to sell a specified number of such shares at a stipulated price per share; |
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a combination of any such methods of sale; and |
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any other method permitted pursuant to applicable law. |
The selling stockholder may also sell shares under Rule 144 under the Securities Act, if
available, rather than under this prospectus. The selling stockholder is not obligated to, and
there is no assurance that the selling stockholder will, sell all or any of the shares we are
registering. The selling stockholder may transfer, devise or gift such shares by other means not
described in this prospectus.
The selling stockholder may also engage in short sales against the box, puts and calls and
other transactions in our securities or derivatives of our securities and may sell or deliver
shares in connection with these trades.
Broker-dealers engaged by the selling stockholder may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the selling
stockholder (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated. The selling stockholder does not expect these commissions
and discounts to exceed what is customary in the types of transactions involved. Any profits on
the resale of shares of common stock by a broker-dealer acting as principal might be deemed to be
underwriting discounts or commissions under the Securities Act. Discounts, concessions,
commissions and similar selling expenses, if any, attributable to the sale of shares will be borne
by the selling stockholder. The selling stockholder may agree to indemnify any agent, dealer or
broker-dealer that participates in transactions involving sales of the shares if liabilities are
imposed on that person under the Securities Act.
The selling stockholder may from time to time pledge or grant a security interest in some or
all of the shares of common stock owned by it and, if it defaults in the performance of any of its
secured obligations, the pledgees or secured parties may offer and sell the shares of common stock
from time to time under this prospectus as it may be supplemented from time to time, or under an
amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities
Act amending the list of selling stockholders to include the pledgee, transferee or other
successors in interest as selling stockholders under this prospectus.
The selling stockholder also may transfer the shares of common stock in other circumstances,
in which case the transferees, pledgees or other successors in interest will be the selling
beneficial owners for purposes of this prospectus.
The selling stockholder has advised us that it has not entered into any agreements,
understandings or arrangements with any underwriters or broker-dealers regarding the sale of its
shares of common stock, nor is there an underwriter or coordinating broker acting in connection
with a proposed sale of shares of common stock by it. If we are notified by the selling
stockholder that any material arrangement has been entered into with a broker-dealer for the sale
of shares of common stock, if required, we will file a supplement to this prospectus. If the
selling stockholder uses this prospectus for any sale of the shares of common stock, it will be
subject to the prospectus delivery requirements of the Securities Act, unless an exemption
therefrom is available.
The anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of our
common stock and activities of the selling stockholder.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale by the selling stockholder of any of the
shares of common stock offered for resale through this prospectus. All proceeds from the resale of
the shares of our common stock offered for resale through this prospectus will be for the account
of the selling stockholder.
LEGAL MATTERS
The validity of the shares of common stock being offered hereby will be passed upon for us by
Jones, Walker, Waechter, Poitevent, Carrère & Denègre, L.L.P., New Orleans, Louisiana.
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EXPERTS
The financial statements incorporated by reference in this prospectus have been audited by BDO
Seidman, LLP, an independent registered public accounting firm, to the extent and for the periods
set forth in their report incorporated herein by reference, and are incorporated herein in reliance
upon such report given upon the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We have filed a Registration Statement on Form S-3 under the Securities Act, relating to the
shares of common stock being offered by this prospectus, and reference is made to such registration
statement. This prospectus constitutes the prospectus of Akorn, Inc., filed as part of the
registration statement, and it does not contain all information in the registration statement, as
certain portions have been omitted in accordance with the rules and regulations of the SEC.
We are subject to the informational requirements of the Exchange Act, which requires us to
file reports, proxy statements and other information with the SEC. You may inspect any document we
file with the SEC at the SECs Public Reference Room at 100 F Street, N.E., Washington D.C. 20549.
Copies of such material can be obtained from the facility at prescribed rates. Please call the SEC
toll free at 1-800-SEC-0330 for information about its public reference room. Because we file
documents electronically with the SEC, you may also obtain this information by visiting the SECs
website at http://www.sec.gov or our website at http://www.akorn.com. You can also inspect reports
and other information we file at the offices of the American Stock Exchange, 86 Trinity Place, New
York, NY 10006. Information contained in our web site is not part of this prospectus.
We will also provide to each person, including any beneficial owner, to whom a prospectus is
delivered, a copy of any or all of the information that has been incorporated by reference in this
prospectus but not delivered with the prospectus. Such information will be provided upon written
or oral request and at no cost to the requester. Any such request may be made by writing or
calling us at the following address or telephone number:
Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove, Illinois 60089
Attention: Chief Financial Officer
(847) 279-6100
Exhibits to a document will not be provided unless they are specifically incorporated by
reference in that document.
Our statements in this prospectus about the contents of any contract or other document are not
necessarily complete. You should refer to the copy of our contract or other document we have filed
for complete information.
You should rely only on the information incorporated by reference or provided in this
prospectus. We have not authorized anyone else to provide you with different information. The
selling stockholder is not making an offer of these securities in any state where the offer is not
permitted. You should not assume that the information in this prospectus is accurate as of any
date other than the date on the front of the document. We furnish our stockholders with annual
reports containing audited financial statements.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to incorporate by reference some of the documents we file with it, which
means that we can disclose important information to you by referring you to those documents. This
prospectus incorporates important business and financial information about us which is not included
in or delivered with this prospectus. The information incorporated by reference is an important
part of, and is considered to be a part of, this prospectus, and information that we file later
with the SEC will automatically update and supersede this information.
We incorporate by reference the following documents:
our Annual Report on Form 10-K for the year ended December 31, 2005, as filed on March 30, 2006;
13
our Quarterly Reports on Form 10-Q for each of the quarters ended March 31, 2006, June
30, 2006 and September 30, 2006, as filed on May 15, 2006, August 10, 2006 and November 9, 2006,
respectively;
our Current Reports on Form 8-K, including amendments thereto, filed with the SEC
since December 31, 2005, other than any information furnished pursuant to Item 2.02 or Item 7.01;
the description of our common stock contained in the section entitled Description of
Capital Stock and Convertible Securities, included in our Post Effective Amendment No. 2 to
Registration Statement on Form S-1, No. 333-119168 filed with the SEC on June 14, 2005, and any
amendment or report filed for the purpose of updating such description;
all documents filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act after the date of this prospectus and prior to the termination of the offering
of shares hereunder; and
all documents filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act, other than any information furnished pursuant to Item 2.02 or Item 7.01 of
Form 8-K, after the date of the initial registration statement and prior to the effectiveness of
the registration statement of which this prospectus forms a part shall be deemed to be incorporated
by reference in this prospectus and to be part of this prospectus from the date they are filed.
14
Until the completion of the resale of
the common stock included in this
prospectus, all dealers that effect
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.
Table of Contents
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About this Prospectus |
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1 |
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Forward-Looking Statements and Factors Affecting Future Results |
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1 |
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Summary |
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2 |
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Risk Factors |
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3 |
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Selling Stockholder |
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11 |
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Plan of Distribution |
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11 |
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Use of Proceeds |
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12 |
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Legal Matters |
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12 |
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Experts |
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13 |
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Where You Can Find More Information |
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13 |
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Information Incorporated by Reference |
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13 |
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The Resale of
1,000,000 Shares
of
Common Stock
Offered by
Selling Securityholders
AKORN, INC.
PROSPECTUS
Subject to Completion, [ ], 2006
We have not authorized any dealer, salesperson or other person to give you written information
other than this prospectus or to make representations as to matters not stated in this prospectus.
You must not rely on unauthorized information. This prospectus is not an offer to sell these
securities or our solicitation of your offer to buy the securities in any jurisdiction where that
would not be permitted or legal. Neither the delivery of this prospectus nor any of the sales made
hereunder after the date of this prospectus shall create an implication that the information
contained herein or our affairs have not changed since the date hereof.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The expenses in connection with the issuance and distribution of the securities being
registered in this registration statement are set forth in the following table. The selling
security holders will bear none of the following expenses. All amounts except the registration fee
are estimated.
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Registration Fees |
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$ |
465 |
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Transfer Agent Fees |
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1,000 |
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Legal Fees |
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10,000 |
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Accounting Fees |
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15,000 |
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Miscellaneous |
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1,000 |
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Total |
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$ |
27,465 |
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Item 15. Indemnification of Directors and Officers
Incorporated by reference to Item 15. Indemnification of Directors and Officers included in
Post-Effective No. 2 to our Registration Statement on Form S-1, No. 333-119168 filed with the SEC
on June 14, 2005.
Item 16. Exhibits
(a) Those exhibits marked with an asterisk (*) refer to exhibits filed herewith. The other
exhibits are incorporated herein by reference, as indicated in the following list.
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Exhibit No. |
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Description |
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4.1
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First Amendment dated October 7, 2003 to Registration Rights Agreement dated July 12, 2001
between Akorn, Inc. and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to
Exhibit 4.1 to Akorn, Inc.s report on Form 8-K filed on October 24, 2003. |
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4.2
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Form of Warrant Certificate, incorporated by reference to Exhibit 4.2 to Akorn, Inc.s report on
Form 8-K filed on October 24, 2003. |
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4.3
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Form of Warrant Agreement dated October 7, 2003 between Akorn, Inc. and certain investors,
incorporated by reference to Exhibit 4.3 to Akorn, Inc.s report on Form 8-K filed on October 24,
2003. |
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4.4
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Warrant Agreement dated October 7, 2003 between Akorn, Inc. and The John N. Kapoor Trust dated
9/20/89, incorporated by reference to Exhibit 4.4 to Akorn, Inc.s report on Form 8-K filed on
October 24, 2003. |
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4.5
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Warrant Agreement dated October 7, 2003 between Akorn, Inc. and Arjun C. Waney, incorporated by
reference to Exhibit 4.5 to Akorn, Inc.s report on Form 8-K filed on October 24, 2003. |
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4.6
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Warrant Agreement dated October 7, 2003 between Akorn, Inc. and The John N. Kapoor Trust dated
9/20/89, incorporated by reference to Exhibit 4.6 to Akorn, Inc.s report on Form 8-K filed on
October 24, 2003. |
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4.7
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Warrant Agreement dated October 7, 2003 between Akorn, Inc. and Arjun C. Waney, incorporated by
reference to Exhibit 4.7 to Akorn, Inc.s report on Form 8-K filed on October 24, 2003. |
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4.8
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Warrant Agreement dated October 7, 2003 between Akorn, Inc. and Argent Fund Management Ltd.,
incorporated by reference to Exhibit 4.8 to Akorn, Inc.s report on Form 8-K filed on October 24,
2003. |
II-1
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Exhibit No. |
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Description |
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4.9
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Registration Rights Agreement dated October 7, 2003 among Akorn, Inc. and certain investors,
incorporated by reference to Exhibit 4.9 to Akorn, Inc.s report on Form 8-K filed on October 24,
2003. |
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4.10
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Form of Subscription Agreement between Akorn, Inc. and certain investors, incorporated by
reference to Exhibit 4.1 to Akorn, Inc.s report on Form 8-K filed on August 24, 2004. |
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4.11
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Form of Common Stock Purchase Warrant between Akorn, Inc. and certain investors, incorporated by
reference to Exhibit 4.2 to Akorn, Inc.s report on Form 8-K filed on August 24, 2004. |
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4.12
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Warrant Purchase and Registration Agreement dated June 18, 2003 between Akorn, Inc. and AEG
Partners LLC, incorporated by reference to Exhibit 4.1 to Akorn, Inc.s report on Form 8-K filed
on August 27, 2004. |
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4.13
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Stock Registration Rights Agreement dated November 15, 1990 between Akorn, Inc. and The John N.
Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit 4.12 to Akorn, Inc.s
Registration Statement on Form S-1 filed on September 21, 2004. |
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4.14
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Stock Purchase Agreement dated November 15, 1990 between Akorn, Inc. and The John N. Kapoor Trust
dated 9/20/89, incorporated by reference to Exhibit 4.13 to Akorn, Inc.s Registration Statement
on Form S-1 filed on September 21, 2004. |
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4.15
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Form of Securities Purchase Agreement dated March 1, 2006, between Akorn, Inc. and certain
investors incorporated by reference to Exhibit 4.1 to Akorn, Inc.s report on Form 8-K filed on
March 7, 2006. |
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4.16
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Form of Warrant issued in connection with the Securities Purchase Agreement dated March 1, 2006
incorporated by reference to Exhibit 4.2 to Akorn, Inc.s report on Form 8-K filed March 7, 2006.
(All warrants are dated March 8, 2006. Please see Exhibit 99.1 of Akorn, Inc.s report on Form
8-K filed March 14, 2006, which is hereby incorporated by reference, for a schedule setting forth
the other material details for each of the warrants.) |
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4.17
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Form of Securities Purchase Agreement dated September 13, 2006, between Akorn, Inc. and Serum
Institute of India Limited incorporated by reference to Exhibit 4.1 to Akorn, Inc.s report on
Form 8-K filed on September 14, 2006. |
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5.1*
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Opinion of Jones, Walker, Waechter, Poitevent, Carrère & Denègre, L.L.P. |
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23.1*
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Consent of BDO Seidman, LLP, independent registered public accounting firm. |
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23.2*
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Consent of Jones, Walker, Waechter, Poitevent, Carrère & Denègre, LLP, incorporated by reference
to Exhibit 5.1 to this Registration Statement. |
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24.1
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Power of Attorney (incorporated by reference to the signature page of this Registration Statement) |
Item 17. Undertakings
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) to reflect in the prospectus any facts or events arising after the effective date of this
registration statement (or the most recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the information in this registration statement.
To reflect in the prospectus any facts or events arising after the effective date of the
registration statement (or the most recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and
any deviation from the low or high end of the estimated maximum offering range may be reflected in
the form of prospectus filed with the
II-2
Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than 20 percent change in the maximum aggregate offering price set forth in the
Calculation of Registration Fee table in the effective registration statement; and
(iii) to include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such information in
the registration statement; provided, however, that paragraphs (i), (ii) and (iii) do not apply if
the registration statement is on Form S-3 or Form F-3, and the information required to be included
in a post-effective amendment by those paragraphs is contained in reports filed with or furnished
to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in the registration statement, or is
contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration
statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof, and
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) That, for purposes of determining liability under the Securities Act of 1933, to any
purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than
prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the
registration statement as of the date it is first used after effectiveness. Provided, however,
that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the
registration statement or prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such first use, supersede or modify any
statement that was made in the registration statement or prospectus that was part of the
registration statement or made in any such document immediately prior to such date of first use.
The undersigned registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act of 1933, each filing of the registrants annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 that is incorporated by reference in
this registration statement shall be deemed to be a new registration statement relating to the
securities offered herein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act, and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred or paid by a
director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it
has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and
has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Buffalo Grove, State of Illinois, on November 14, 2006.
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AKORN, INC.
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By: |
/s/ Jeffrey A. Whitnell
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Jeffrey A. Whitnell |
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Chief Financial Officer,
Treasurer and Secretary |
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We, the undersigned officers and directors of Akorn, Inc., hereby severally constitute and
appoint each of Messrs. Arthur S. Przybyl and Jeffrey A. Whitnell as our true and lawful
attorneys-in-fact, with full power to each of them, to sign for us in our names in the capacities
indicated below, any amendments to this Registration Statement on Form S-3 including post-effective
amendments, and to file the same, with all exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission, and generally to do all things in our names
and on our behalf in our capacities as officers and directors to enable Akorn, Inc. to comply with
the provisions of the Securities Act of 1933, as amended, and all requirements of the Securities
and Exchange Commission, hereby ratifying and confirming our signatures as they may be signed by
our said attorneys-in-fact to said Registration Statement and any and all amendments thereto.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has
been signed below by the following persons in the capacities and on the dates indicated.
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Signature |
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Title |
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Date |
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/s/ Arthur S. Przybyl
Arthur S. Przybyl
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Director, President and Chief Executive Officer
(Principal Executive Officer)
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November 14, 2006 |
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/s/ Jeffrey A. Whitnell
Jeffrey A. Whitnell
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Chief Financial Officer, Treasurer and
Secretary (Principal Financial Officer
and Principal Accounting Officer)
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November 14, 2006 |
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Chairman and Director
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November ___, 2006 |
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/s/ Jerry N. Ellis
Jerry N. Ellis
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Director
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November 14, 2006 |
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/s/
Jerry Treppel |
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Director
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November 14, 2006 |
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Director
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November ___, 2006 |