e10vk
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Form 10-K
|
|
|
þ |
|
Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the year ended December 31, 2006
|
|
|
o |
|
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
Commission File Number: 0-13976
AKORN, INC.
(Name of registrant as specified in its charter)
|
|
|
LOUISIANA
|
|
72-0717400 |
(State or other jurisdiction of
|
|
(IRS Employer Identification No.) |
incorporation or organization) |
|
|
2500 Millbrook Drive, Buffalo Grove, Illinois 60089
(Address of principal executive offices and zip code)
Registrants telephone number: (847) 279-6100
SECURITIES REGISTERED UNDER SECTION 12(b) OF THE EXCHANGE ACT:
|
|
|
Title of each class
|
|
Name of each exchange on which registered |
|
|
|
Common Stock, No Par Value
|
|
The NASDAQ Stock Market LLC |
SECURITIES REGISTERED UNDER SECTION 12(g) OF THE EXCHANGE ACT:
(None)
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of
the Securities Act. Yes o No þ
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or
Section 15(d) of the Act. Yes o No þ
Note Checking the box above will not relieve any Registrant required to file reports pursuant to
Section 13 or 15(d) of the Exchange Act from their obligation under those Sections.
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period
that the Registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers in response to Item 405 of Regulation S-K
is not contained in this form, and will not be contained, to the best of Registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (check one):
Large accelerated filer: o Accelerated filer: þ Non-accelerated filer: o
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the
Act). Yes o No þ
The aggregate market value of the voting stock of the Registrant held by non-affiliates (affiliates
being, for these purposes only, directors, executive officers and holders of more than 5% of the
Registrants common stock) of the Registrant as of June 30, 2006 was approximately $116,511,997.
The number of shares of the Registrants common stock, no par value per share, outstanding as of
March 8, 2007 was 86,374,771.
Documents incorporated by reference: Definitive Proxy Statement for the 2007 Annual Meeting
incorporated by reference into Part III, Items 10-14 of this Form 10-K.
Forward-Looking Statements and Factors Affecting Future Results
Certain statements in this Form 10-K constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act. When used in this document, the words
anticipate, believe, estimate and expect 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:
|
|
|
Our ability to comply with all of the requirements of the Food and Drug Administration,
including current Good Manufacturing Practices regulations; |
|
|
|
|
Our ability to obtain regulatory approvals of, commence operations at and obtain business
for our new lyophilization facility; |
|
|
|
|
Our ability to avoid defaults under debt covenants; |
|
|
|
|
Our ability to generate cash from operations sufficient to meet our working capital requirements; |
|
|
|
|
The effects of federal, state and other governmental regulation on our business; |
|
|
|
|
Our success in developing, manufacturing, acquiring and marketing new products; |
|
|
|
|
The success of our strategic partnerships for the development and marketing of new products; |
|
|
|
|
Our ability to bring new products to market and the effects of sales of such products on our financial results; |
|
|
|
|
The effects of competition from generic pharmaceuticals and from other pharmaceutical companies; |
|
|
|
|
Availability of raw materials needed to produce our products; and |
|
|
|
|
Other factors referred to in this Form 10-K and our other Securities and Exchange Commission filings. |
See Item 1A. Risk Factors on pages 8 through 15. You should read this report 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.
2
FORM 10-K TABLE OF CONTENTS
3
PART I
Item 1. Business
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 hospital drugs & injectables segments.
We classify our operations into three identifiable business segments, ophthalmic, hospital
drugs & injectables and contract services. These three segments are described in greater detail
below. For information regarding revenues and gross profit for each of our segments, see Item 8.
Financial Statements and Supplementary Data, Note M Segment Information.
Ophthalmic Segment. We market 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 & Injectables Segment. We market a line of specialty injectable pharmaceutical
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.
Contract Services Segment. We manufacture products for third party pharmaceutical and
biotechnology customers based on their specifications.
Manufacturing. We have manufacturing facilities located in Decatur, Illinois and Somerset, New
Jersey. See Item 2. Properties. We manufacture a diverse group of sterile pharmaceutical products,
including solutions, ointments and suspensions for our ophthalmic and hospital drugs & injectables
segments. Our Decatur facility manufactures products for all three of our segments. Our Somerset
facility manufactures ophthalmic solutions and ointment products. We have added freeze-dried
(lyophilized) manufacturing capabilities at our Decatur manufacturing facility and are currently
waiting for a Pre-Approval Inspection (PAI) from the U.S. Food and Drug Administration (FDA) to
begin using the lyophilization facility for commercial production. We intend to develop an
internal Abbreviated New Drug Application (ANDA) lyophilized product pipeline. See Item 1A. Risk
Factors Our growth depends on our ability to timely develop additional pharmaceutical products
and manufacturing capabilities.
Sales and Marketing. While we are working to expand our proprietary product base through
internal development and external product licensing development, the majority of our current
products are non-proprietary. We rely on our efforts in marketing, distribution, product
development and low cost manufacturing to maintain and increase our market share.
Our ophthalmic segment uses a three-tiered sales effort. Outside sales representatives sell
directly to retina surgeons and ophthalmic group practices. In-house sales (telemarketing) and
customer service (catalog sales) sell to office-based ophthalmic physicians and hospitals. A
national account group contracts with wholesalers, retail chains and other group purchasing
organizations that represent hospitals in the United States. Contract services markets our contract
manufacturing services through direct mail, trade shows and direct industry contacts.
Research and Development. In 2006, we received 11 ANDA product approvals from the Office of
Generic Drugs. As of December 31, 2006, we had 35 ANDA product submissions for generic
pharmaceuticals under review at the Office of Generic Drugs: 16 from internal development and 19
from various strategic agreements with nine external partners. In most, but not all, instances we
own the ANDAs that are produced by our strategic partnerships. We plan to continue to file ANDAs on
a regular basis as pharmaceutical products come off patent allowing us to compete by marketing
generic equivalents. See Government Regulation beginning on page seven.
4
In 2004 we began to enter into strategic partnerships for the development and marketing of a
number of products, a discussion of which is below:
Under an agreement we entered into in 2004 with Strides Arcolab Limited (Strides),
Akorn-Strides, LLC (the Joint Venture Company), of which we and Strides are both 50% owners, is
developing patent-challenge products and ANDA products for the U.S. hospital and retail markets.
We have each funded Akorn-Strides, LLC with $1,500,000. See Item 8. Financial Statements and
Supplementary Data, Note Q Business Alliances. As our strategic partner, Strides is
responsible for developing, manufacturing and supplying products that we will sell and market in
the United States on an exclusive basis.
Also in 2004, we and FDC Limited entered into a purchase and supply agreement, which would
provide us with an ophthalmic finished dosage form product pipeline for exclusive use in the United
States and Canada. FDC Limited is to develop and manufacture the ophthalmic products, which we will
market directly in the United States.
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, Ltd.
(Serum). Serum is currently building a facility in Pune, India for the manufacture of these
products. We will own the ANDAs and buy products developed under the agreement from Serum 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.
On November 16, 2004, we entered into an Exclusive License and Supply Agreement with Hameln
Pharmaceuticals (Hameln) for two Orphan Drug New Drug Applications (NDAs) Calcium-DTPA and
Zinc-DTPA which were both approved by the FDA in August 2004. These products are antidotes for
the treatment of radioactive poisoning. Under the terms of the agreement, we paid a one-time
license fee of 1,550,000 Euros ($2,095,000) for an exclusive license for five years, subject to
extension for successive two-year periods. Orphan drug exclusivity status is granted by the FDA for
a period of seven years from the date of approval of the NDA. Hameln manufactures both drugs, and
we market and distribute both drugs in the United States and Canada. We share revenues 50:50,
subject to adjustments. We pay any annual FDA establishment fees and for the cost of any
post-approval studies. On December 30, 2005 we were awarded a $21,491,000 contract from the United
States Department of Health and Human Services (HHS) for these products which we subsequently
sold to HHS in March of 2006. In December 2006 we sold HHS an additional $3,502,000 of these
antidote products.
During 2005, we paid M.D. Anderson $75,000 for the right to license a patent from The
University of Texas M.D. Anderson Cancer Center called M-EDTA Pharmaceutical Preparations of Uses
Thereof. Under the terms of the agreement we entered into with M.D. Anderson, we will also fund
clinical trials and pay a milestone license fee upon FDA approval and then pay royalties for the
life of the patent.
On March 7, 2006, we entered into a 10-year exclusive agreement with Cipla, Ltd. (Cipla), an
Indian pharmaceutical company located in Mumbai, India. Under the terms of the agreement, Cipla
manufactures and supplies an oral anti-infective ANDA drug product using our formulation, and we
are responsible for the ANDA regulatory submission and clinical development. We also fund the
purchase of specialized manufacturing equipment and pay Cipla milestone fees for Ciplas assistance
with ANDA development and submission. We agreed to purchase the product from Cipla and Cipla agreed
to supply the product to us on an exclusive basis in the United States. We will own the ANDA in the
United States.
On November 8, 2006, we entered into both a Development and Exclusive Distribution Agreement
(the Development and Exclusive Distribution Agreement) and a Development Funding Agreement
(Development Funding Agreement and together with the Development and Exclusive Distribution
Agreement, the Agreements) with Serum. Under the Agreements, Serum has agreed to appoint us as
the exclusive distributor for Rabies monoclonal antibody (the Product). In exchange for us
receiving exclusive marketing and distribution rights for the Product to North, Central, and South
America, we have agreed to help fund development of the Product through milestone payments. These
milestone payments include the successful completion of Phase I, Phase II, and Phase III clinical
trials and receipt of approval for a biologics license application from the FDAs Center for
Biologics Evaluation and Research. As the exclusive marketing and distribution partner of Serum for
the Product in America, we will receive 40% of the revenues from Product sales in North America and
50% of the revenues from Product sales in Central and South America. Also as part of the
Development and Exclusive Distribution Agreement, Serum grants us the first option right to obtain
exclusive marketing rights in North, Central, and South America for a second monoclonal antibody
product, Anti-D human monoclonal antibody (Anti-D). The exclusive marketing rights for Anti-D
would be consistent with the terms and conditions in the Agreements for the Product.
5
Additionally, Serum has granted us the first option right to expand the territory in which it has
exclusive rights to include Europe in exchange for minimum annual product sales requirements in
Europe.
Pre-clinical and clinical trials required in connection with the development of pharmaceutical
products are performed by contract research organizations under the direction of our personnel. No
assurance can be given as to whether we will file NDAs, or ANDAs, when anticipated, whether we will
develop marketable products based on any filings we do make, or as to the actual size of the market
for any such products, or as to whether our participation in such market would be profitable. See
Government Regulation on page seven and Item 1A. Risk Factors Our growth depends on our
ability to timely develop additional pharmaceutical products and manufacturing capabilities.
We also maintain a business development program that identifies potential product acquisition
or product licensing candidates. We have focused our business development efforts on products that
complement our existing product lines and that have few or no competitors in the market.
At December 31, 2006, twelve of our full-time employees were involved in product research and
business development.
Research and development costs are expensed as incurred. Such costs amounted to $11,797,000,
$4,510,000, and $1,861,000, for the years ended December 31, 2006, 2005, and 2004, respectively.
Patents, Trademarks and Proprietary Rights. We consider the protection of discoveries in
connection with our development activities important to our business. We have sought, and intend to
continue to seek, patent protection in the United States and selected foreign countries where
deemed appropriate. As of December 31, 2006, we had received seven U.S. patents and had four
additional U.S. patent applications pending.
We also rely upon trademarks, trade secrets, unpatented proprietary know-how and continuing
technological innovation to maintain and develop our competitive position. We enter into
confidentiality agreements with certain of our employees pursuant to which such employees agree to
assign to us any inventions relating to our business made by them while in our employ. However,
there can be no assurance that others may not acquire or independently develop similar technology
or, if patents are not issued with respect to products arising from research, that we will be able
to maintain information pertinent to such research as proprietary technology or trade secrets. See
Item 1A. Risk Factors Our patents and proprietary rights may not adequately protect our
products and processes.
Employee Relations. At December 31, 2006, we had 371 full-time employees, 310 of whom were
employed by us and 61 by our wholly owned subsidiary, Akorn (New Jersey), Inc. Akorn-Strides, LLC
has no employees. We believe we enjoy good relations with our employees, none of whom are
represented by a collective bargaining agent.
Competition. The marketing and manufacturing of pharmaceutical products is highly competitive,
with many established manufacturers, suppliers and distributors actively engaged in all phases of
the business. Most of our competitors have substantially greater financial and other resources,
including greater sales volume, larger sales forces and greater manufacturing capacity. See Item
1A. Risk Factors Our industry is very competitive. Additionally changes in technology could
render our products obsolete.
The companies that compete with our ophthalmic segment include Alcon Laboratories, Inc.,
Allergan Pharmaceuticals, Inc., Novartis and Bausch & Lomb, Inc. The ophthalmic segment competes
primarily on the basis of price and service.
The companies that compete with our hospital drugs & injectables segment include both generic
and name brand companies such as Hospira, Teva Pharmaceutical Industries, Abraxis Pharmaceutical
Products and Baxter International. The hospital drugs & injectables segment competes primarily on
the basis of price.
Competitors in our contract services segment include Baxter International, Hospira and
Patheon. The contract services segment competes primarily on the basis of price and technical
capabilities.
Suppliers and Customers. In 2006 purchases from Hameln represented approximately 13% of our
purchases and in both 2005 and 2004, purchases from Cardinal Health PTS, LLC accounted for
approximately 17% of our purchases. 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. The principal components of our products are active and inactive pharmaceutical
ingredients and certain packaging materials. Many of these components are available from only a
single source and, in the case of many of our ANDAs and NDAs, only
6
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.
In 2006 we sold $25,464,000 of our radiation DTPA antidote products to HHS which represented
36% of our sales in 2006. There were no sales to HHS in 2005. In addition, a small number of
large wholesale drug distributors account for a large portion of our gross sales, revenues and
accounts receivable. Those distributors are:
|
|
|
AmerisourceBergen Corporation (AmerisourceBergen) |
|
|
|
|
Cardinal Health, Inc. (Cardinal); and |
|
|
|
|
McKesson Drug Company (McKesson). |
These three wholesale drug distributors accounted for approximately 50% of our total gross
sales and 33% of our revenues in 2006, and 53% of our gross accounts receivable as of December 31,
2006. The difference between gross sales and revenue is that gross sales do not reflect the
deductions for chargebacks, rebates and product returns (See Item 7. Managements Discussion and
Analysis of Financial Condition and Results of Operations Critical Accounting Policies). The
percentages of gross sales, revenue and gross trade receivables attributed to each of these three
wholesale drug distributors for the years ended December 31, 2006 and December 31, 2005 were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
|
Gross |
|
Net |
|
Gross Accounts |
|
Gross |
|
Net |
|
Gross Accounts |
|
|
Sales |
|
Revenue |
|
Receivable |
|
Sales |
|
Revenue |
|
Receivable |
AmerisourceBergen |
|
|
13 |
% |
|
|
9 |
% |
|
|
12 |
% |
|
|
24 |
% |
|
|
16 |
% |
|
|
28 |
% |
Cardinal |
|
|
19 |
% |
|
|
13 |
% |
|
|
24 |
% |
|
|
28 |
% |
|
|
19 |
% |
|
|
29 |
% |
McKesson |
|
|
18 |
% |
|
|
11 |
% |
|
|
17 |
% |
|
|
17 |
% |
|
|
11 |
% |
|
|
19 |
% |
AmerisourceBergen, Cardinal and McKesson are distributors of our products as well as a
broad range of health care products for many other companies. None of these distributors is an end
user of our products. If sales to any one of these distributors were to diminish or cease, we
believe that the end users of our products would find little difficulty obtaining our products
either directly from us or from another distributor. However, 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, business, financial condition and
results of operations. We consider our business relationships with these three wholesalers to be in
good standing and have fee for services contracts with Cardinal and McKesson. We have also
established a fee for service contract with AmerisourceBergen, which began in January 2006. A
change in purchasing patterns, a decrease in inventory levels, an increase 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, business, financial
condition and results of operations. See Item 1A Risk factors We depend on a small number of
distributors, the loss of any of which could have a material adverse effect.
Backorders. As of December 31, 2006, we had approximately $737,000 of products on backorder as
compared to approximately $1,400,000 of backorders as of December 31, 2005. This decrease in
backorders is due to higher production levels in 2006. We anticipate filling all current open
backorders during 2007.
Government Regulation. Pharmaceutical manufacturers and distributors are subject to extensive
regulation by government agencies, including the FDA, the Drug Enforcement Administration (DEA),
the Federal Trade Commission (FTC) and other federal, state and local agencies. The federal Food,
Drug and Cosmetic Act (the FDC Act), the Controlled Substance Act and other federal statutes and
regulations govern or influence the development, testing, manufacture, labeling, storage and
promotion of products that we manufacture and market. The FDA inspects drug manufacturers and
storage facilities to determine compliance with its current Good Manufacturing Practices (cGMP)
regulations, non-compliance with which can result in fines, recall and seizure of products, total
or partial suspension of production, refusal to approve NDAs and criminal prosecution. The FDA also
has the authority to revoke approval of drug products.
7
FDA approval is required before any drug can be manufactured and marketed. New drugs require
the filing of an NDA, including clinical studies demonstrating the safety and efficacy of the drug.
Generic drugs, which are equivalents of existing, off-patent brand name drugs, require the filing
of an ANDA. An ANDA does not, for the most part, require clinical studies since safety and efficacy
have already been demonstrated by the product originator. However, the ANDA must provide data
demonstrating the equivalency of the generic formulation in terms of bioavailability. The time
required by the FDA to review and approve NDAs and ANDAs is variable and beyond our control.
FDA Warning Letter. The FDA issued a Warning Letter to us in October 2000 following a routine
inspection of our Decatur manufacturing facility. Since 2000, and in response to the violations cited by the FDA, we implemented a comprehensive
systematic compliance plan at our Decatur manufacturing facility. We maintained regular
communications with the FDA and provided periodic progress reports. During this time, the FDA initiated no enforcement action. On December 13, 2005, the FDA notified us that we had satisfactorily implemented corrective
actions and the FDA had determined that our Decatur manufacturing facility was in substantial
compliance with cGMP regulations. Consequently, the restrictions of the Warning Letter were
removed and we became eligible for new product approvals for products manufactured at our Decatur
manufacturing facility. Several such product approvals were received in 2006. While under the Warning Letter restrictions from 2000 to 2005, our inability to fully utilize
the capabilities of the Decatur manufacturing facility had a material adverse effect on our
business, financial condition and results of operations.
Product Recalls. There were no product recalls during 2006, 2005 or 2004.
DEA Regulation. We also manufacture and distribute several controlled-drug substances, the
distribution and handling of which are regulated by the DEA. Failure to comply with DEA regulations
can result in fines or seizure of product.
Environment. We do not anticipate any material adverse effect from compliance with federal,
state and local provisions that have been enacted or adopted regulating the discharge of materials
into the environment, or otherwise relating to the protection of the environment.
Foreign Sales. During 2006, 2005 and 2004, approximately $1,104,000, $3,666,000 and
$5,435,000, respectively, of our revenues were from external customers located in foreign
countries. The decline in volume is primarily due to one customer switching over to internally
sourcing an ophthalmic product they had previously purchased from us in 2005 and 2004.
Item 1A. Risk Factors.
We have experienced recent operating losses, working capital deficiencies and negative cash flows
from operations, and these losses and deficiencies may continue in the future.
Our recent operating losses may continue in the future and there can be no assurance that our
financial outlook will improve. For the years ended December 31, 2006, 2005 and 2004, our operating
losses were $4,905,000, $ 7,479,000 and $368,000, respectively. We generated a positive cash flow
from operations in 2006 of $2,509,000, however we generated negative flows of $148,000 and
$3,461,000 in 2005 and 2004, respectively. There can be no assurance that our results of
operations will reflect improvement in the future. If our results of operations do not 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. As of December 31, 2006, we had spent approximately
$22,433,000 on the lyophilization facility expansion and anticipate the need to spend approximately
$200,000 of additional funds (excluding capitalized interest) which will primarily be used for
testing and validation as the major capital equipment items are currently in place. In December
2006, we placed the sterile solutions portion of this operation in service which augments our
existing production capacities. The remaining $5,196,000 of construction in progress, which is
specific to lyophilization (freeze-dry) operations, is awaiting final review and a PAI by the FDA
for us to place this equipment into commercial production.
We are working toward the development of an internal ANDA lyophilized product pipeline and
expect manufacturing capabilities for lyophilized products to be in place by mid-2007. However,
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,
Cardinal and McKesson, accounted for approximately 50% of total gross sales and 33% of total
revenues in 2006, and 53% of gross trade receivables as of December 31, 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.
Certain of our directors are subject to conflicts of interest.
Dr. John N. Kapoor, Ph.D., the 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. (EJ Financial), 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 (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.
9
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 distributions 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 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
significantly lower than that 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.
10
We can be subject to legal proceedings against us, 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 actions 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. See Item 3. Legal Proceedings.
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, including our competitors in some instances. 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, DEA, FTC, 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 and/or state or local 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. See Item 1. Business Government Regulation.
FDA regulations. All pharmaceutical manufacturers, including us, are subject to regulation by
the FDA under the authority of the FDC Act. Under the FDC Act, the federal government has extensive
administrative and judicial enforcement authority over the activities of finished drug product
manufacturers to ensure compliance with FDA regulations. This authority includes, but is 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 cGMP, to recall products, to seek civil and monetary penalties and to
11
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 which
requires a regulatory submission. 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 pharmaceutical
products. The FDA imposes stringent mandatory requirements on the manufacture and distribution of
pharmaceutical products to ensure their safety and efficacy. 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
which was subsequently removed in 2005. See Item 1. Business FDA Warning Letter.
If the FDA changes its regulatory position, it could force us to delay or suspend our
manufacturing, distribution or sales of certain products. We believe that all of our current
products are in substantial compliance with FDA regulations and have received the requisite agency
approvals for their manufacture and sale. 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 and amendments thereto. 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. Any such change in
the status of a grandfathered product 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. See Item 1. Business DEA Regulation.
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 2006, 2005 or 2004.
12
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.
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
13
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 have
registered 71,785,437 shares held by certain of our investors for sale under registration
statements on a Form S-1 and Form S-3 filed with the Securities and Exchange Commission (SEC).
Sales of these shares on the open market could cause the price of our stock to decline.
Exercise of warrants and options 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
warrants or stock options 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. Holders of our outstanding warrants and options would receive 4,966,487
shares of our common stock at a weighted average exercise price of $2.88 per share. Any additional
financing that we secure likely will require the granting of rights, preferences or privileges
senior to those of our common stock which may 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. 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.
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.
Penny Stock rules may make buying or selling our common stock difficult.
As of March 8, 2007, the market price of our common stock exceeded $5.00 per share. However,
there can be no guarantee that it will continue to do so. If our market price falls below $5.00
per share, trading in our common stock may be 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 would require that
any broker-dealer that would have to recommend 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 would 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
14
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 (the Exchange Act) and the Sarbanes-Oxley Act of 2002 (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.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
Since August 1998, our headquarters and certain administrative offices, as well as a finished
goods warehouse, have been located in leased space at 2500 Millbrook Drive, Buffalo Grove,
Illinois. We lease approximately 48,000 square feet.
We own a 76,000 square foot facility located on 15 acres of land in Decatur, Illinois. This
facility is currently used for packaging, distribution, warehousing and office space. In addition,
we own a 55,000 square-foot manufacturing facility in Decatur, Illinois. Our Decatur facilities
support all three of our segments. We added 10,000 square feet to our Decatur manufacturing
facility to add the ability to provide lyophilization manufacturing services. However, this
lyophilization manufacturing facility still needs to go through validation and approval by the FDA,
which is anticipated in the first half of 2007. Manufacturing capabilities for lyophilized products
are projected to be in place by mid-2007. We currently do not need lyophilization capabilities,
but such capabilities would give us the capability to manufacture additional products for our
contract customers and allow us to pursue other ANDA products and to internally produce one of our
outsourced products. As of December 31, 2006, we had spent approximately $22,433,000 on the
lyophilization expansion and anticipate the need to spend approximately $200,000 of additional
funds (excluding capitalized interest), which will be focused primarily on validation testing. In
December 2006, we placed the building and sterile solutions portion of this operation ($17,237,000)
in service which augments our existing production capacities. The remaining $5,196,000 of
construction in progress, which is specific to lyophilization (freeze-dry) operations, is awaiting
final review and a PAI by the FDA for us to place this equipment into commercial production. We
are working toward the development of an internal ANDA lyophilized product pipeline and expect
manufacturing capabilities for lyophilized products to be in place by mid-2007.
Our wholly owned subsidiary, Akorn (New Jersey) Inc. also leases approximately 35,000 square
feet of space in Somerset, New Jersey. This space is used for manufacturing, research and
development and administrative activities related to our ophthalmic and hospital drugs and
injectables segments.
We do not have any idle manufacturing facilities, however, the capacity utilization at both
our Decatur and Somerset facilities was approximately 80% and 100%, respectively, during the year
ended December 31, 2006. We experienced improved utilization rates at our Decatur facility for 2006
in line with the December 2005 FDA finding that we are in substantial compliance with cGMP
regulations. We can produce approximately 65 batches per month if our Decatur and Somerset
facilities are all operating at normal capacity. Operating the manufacturing facilities at the
reduced level has led to lower gross margins due, in part, to unabsorbed fixed manufacturing costs.
Our current space in Decatur is considered adequate to accommodate our manufacturing needs for
the foreseeable future while we are expanding our manufacturing space at our Somerset production
facility to accommodate new product growth.
15
Item 3. Legal Proceedings.
We are party to legal proceedings and potential claims arising in the ordinary course of our
business. The amount, if any, of ultimate liability with respect to such matters cannot be
determined. Despite the inherent uncertainties of litigation, we at this time do not believe that
such proceedings will have a material adverse impact on our financial condition, results of
operations, or cash flows.
Item 4. Submission of Matters to a Vote of Security Holders.
No matters were submitted to a vote of security holders during the quarter ended December 31,
2006.
16
PART II
Item 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities.
The following table sets forth, for the fiscal periods indicated, the high and low sales
prices or closing bid prices for our common stock for the two most recent fiscal years and for the
first quarter of our current fiscal year. On February 7, 2007 our common stock was listed on the
NASDAQ Global Market under the symbol AKRX. Before such listing from November 24, 2004 until
February 6, 2007, our common stock was listed for trading on the American Stock Exchange under the
symbol AKN. From May 3, 2004 to November 23, 2004, our common stock was traded on the OTC
Bulletin Board under the stock symbol AKRN.OB. The market represented by the OTC Bulletin Board
is extremely limited and the price for our common stock traded on the OTC Bulletin Board is not
necessarily a reliable indication of the value of our common stock. The quotations for the periods
in which our common stock traded on the OTC Bulletin Board reflect inter-dealer prices, without
retail mark-up, markdown or commission and may not represent actual transactions. Trading prices
are based on published financial sources, information received from the American Stock Exchange,
OTC Bulletin Board and Reuters based on all transactions reported on the OTC Bulletin Board and
Reuters. Prior to trading on the OTC Bulletin Board our common stock was traded on the Pink Sheets
from June 25, 2002 until May 2, 2004.
|
|
|
|
|
|
|
|
|
|
|
High |
|
Low |
Year Ending December 31, 2007 |
|
|
|
|
|
|
|
|
1st Quarter (through March 9, 2007) |
|
$ |
6.48 |
|
|
$ |
5.00 |
|
Year Ended December 31, 2006 |
|
|
|
|
|
|
|
|
1st Quarter |
|
|
5.55 |
|
|
|
3.90 |
|
2nd Quarter |
|
|
5.37 |
|
|
|
3.61 |
|
3rd Quarter |
|
|
4.25 |
|
|
|
3.01 |
|
4th Quarter |
|
|
6.61 |
|
|
|
3.40 |
|
Year Ended December 31, 2005 |
|
|
|
|
|
|
|
|
1st Quarter |
|
$ |
3.95 |
|
|
$ |
2.65 |
|
2nd Quarter |
|
|
3.18 |
|
|
|
2.20 |
|
3rd Quarter |
|
|
3.80 |
|
|
|
2.17 |
|
4th Quarter |
|
|
4.91 |
|
|
|
3.12 |
|
As of March 8, 2007, the market price of our common stock exceeded $5.00 per share. However,
there can be no guarantee that it will continue to do so. If our market price falls below $5.00
per share, trading in our common stock may be 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 would require that
any broker-dealer that would have to recommend 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 would 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.
As of March 8, 2007, we had 86,374,771 shares of common stock outstanding, which were held by
approximately 575 stockholders of record. This number does not include stockholders for which
shares are held in a nominee or street name. The closing price of our common stock on March 8,
2007 was $6.00 per share. The transfer agent for our common stock is Computershare Investor
Services, LLC, 2 North LaSalle Street, Chicago, Illinois 60602.
We did not pay cash dividends in 2006, 2005, or 2004 and do not expect to pay dividends on our
common stock in the foreseeable future. Moreover, we are currently prohibited from making any
dividend payment under the terms of our various financing relationships. See Item 7. Managements
Discussion and Analysis of Financial Condition and Results of Operations Financial Condition and
Liquidity beginning on page 22.
On August 23, 2005, we filed a Registration Statement on Form S-3 (File No.333-127794) (the
S-3) with the SEC, which was declared effective on September 7, 2005. Pursuant to Rule 429 under
the Securities Act of 1933, the prospectus included in the S-3 is a combined prospectus and relates
to the previously filed Registration Statement on Form S-1 (File No.333-119168) (the S-1), as to
which the S-3 constitutes Post-Effective Amendment No. 3. Such Post-Effective Amendment became
effective concurrently with the effectiveness of the S-3. The S-3 relates to the resale of
64,964,680 shares, no par value per share, of our common stock by the selling stockholders
identified in the S-3, which have been issued or reserved for issuance upon the conversion or
exercise of shares of our
17
Series A Preferred Stock, shares of Series B Preferred Stock, warrants and convertible notes,
including shares estimated to be issuable or that have been issued in satisfaction of
accrued and unpaid dividends and interest on shares of preferred stock and convertible notes,
respectively. Of the 64,964,680 shares of our common stock registered under the S-3, 60,953,394 of
such shares were registered under the S-1. The shares of common stock registered by the S-3 and the
S-1 represent the number of shares that have been issued or are issuable upon the conversion or
exercise of the Series A Preferred Stock, Series B Preferred Stock, warrants and convertible notes
described in the Registration Statement, including shares estimated to be issuable in satisfaction
of dividends accrued and unpaid through December 31, 2007 on such securities. All shares of Series
A Preferred Stock, Series B Preferred Stock and all convertible notes have been converted to shares
of our common stock.
With respect to the S-1, we estimated the aggregate offering price of the amount registered to
be $182,246,053, which was derived from the average of the bid and asked prices of our common stock
on September 17, 2004, as reported on the OTC Bulletin Board(R). With respect to the S-3, we
estimated the aggregate offering price of the amount registered to be $10,870,585, which was
derived from the average of the high and low prices of our common stock as reported on the American
Stock Exchange on August 18, 2005. Such amounts were estimated solely for the purpose of
calculating the amount of the registration fee pursuant to Rule 457(h) under the Securities Act of
1933. As of March 9, 2007, we are aware of the sale of 6,981,565 shares of common stock by selling
stockholders under the S-3 or the S-1. We do not know at what price such shares were sold, or how
many shares of common stock will be sold in the future or at what price. We have not and will not
receive any of the proceeds from the sale of the shares by the selling stockholders. The selling
stockholders 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, in the ordinary course of business, receive proceeds from the issuance of shares upon
exercise of the warrants described in the S-3 or the S-1, which we will use for working capital and
other general corporate purposes.
EQUITY COMPENSATION PLANS
Equity Compensation Plans Approved by Stockholders.
Our stockholders approved each of the Akorn, Inc. 1988 Incentive Compensation Plan (1988
Plan), under which any of our officers or key employees was eligible to receive stock options as
designated by our board of directors, and the Akorn, Inc. 1991 Stock Option (the 1991 Directors
Plan), under which options were issuable to our directors. The 1988 Plan expired on November 2,
2003 and the 1991 Directors Plan expired December 7, 2001. The Akorn, Inc. 2003 Stock Option Plan
(2003 Stock Option Plan) was approved by the board of directors on November 6, 2003 and approved
by our stockholders on July 8, 2004. On March 29, 2005, our board of directors approved the Amended
and Restated Akorn, Inc. 2003 Stock Option Plan (the Amended 2003 Plan), effective as of April 1,
2005, and this was subsequently approved by our stockholders on May 27, 2005. The Amended 2003 Plan
is an amendment and restatement of the 2003 Stock Option Plan and provides us with the ability to
grant other types of equity awards to eligible participants besides stock options. The aggregate
number of shares of our common stock that may be issued pursuant to awards granted under the
Amended 2003 Plan is 5,000,000. As of December 31, 2006, there were 3,155,000 options and 350,000
restricted stock awards outstanding under the Amended 2003 Plan.
The following table sets forth certain information as of December 31, 2006, with respect to
compensation plans under which our shares of common stock were issuable as of that date. We have
no equity compensation plans that have not been approved by our security holders.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities |
|
|
|
|
|
|
|
|
|
|
|
remaining available |
|
|
|
Number of |
|
|
|
|
|
|
for future issuance |
|
|
|
securities to be |
|
|
|
|
|
|
under equity |
|
|
|
issued upon |
|
|
Weighted-average |
|
|
compensation plans |
|
|
|
exercise of |
|
|
price of |
|
|
(excluding |
|
|
|
outstanding |
|
|
outstanding |
|
|
securities |
|
|
|
options, warrants |
|
|
options, warrants |
|
|
reflected in the |
|
Plan Category |
|
and rights |
|
|
and rights |
|
|
first column) |
|
Equity Compensation plans approved by security holders: |
|
|
3,505,375 |
|
|
$ |
3.40 |
|
|
|
1,177,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
3,505,375 |
|
|
$ |
3.40 |
|
|
|
1,177,236 |
|
|
|
|
|
|
|
|
|
|
|
18
Item 6. Selected Financial Data
The following table sets forth our selected consolidated financial information as of and for
the years ended December 31, 2006, 2005, 2004, 2003, and 2002.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
2002 |
OPERATIONS DATA (000s) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
71,250 |
|
|
$ |
44,484 |
|
|
$ |
50,708 |
|
|
$ |
45,491 |
|
|
$ |
51,419 |
|
Gross profit |
|
|
26,880 |
|
|
|
14,944 |
|
|
|
18,202 |
|
|
|
12,148 |
|
|
|
20,537 |
|
Operating loss (1) |
|
|
(4,905 |
) |
|
|
(7,479 |
) |
|
|
(368 |
) |
|
|
(6,276 |
) |
|
|
(3,565 |
) |
Interest and other expense (2) |
|
|
(1,055 |
) |
|
|
(1,113 |
) |
|
|
(2,650 |
) |
|
|
(6,220 |
) |
|
|
(3,148 |
) |
Pretax loss |
|
|
(5,960 |
) |
|
|
(8,592 |
) |
|
|
(3,018 |
) |
|
|
(12,496 |
) |
|
|
(6,713 |
) |
Income tax provision (benefit) (3) |
|
|
3 |
|
|
|
17 |
|
|
|
8 |
|
|
|
(171 |
) |
|
|
6,239 |
|
Net loss |
|
|
(5,963 |
) |
|
|
(8,609 |
) |
|
|
(3,026 |
) |
|
|
(12,325 |
) |
|
|
(12,952 |
) |
Preferred stock dividends and adjustments (4) |
|
|
(843 |
) |
|
|
(4,082 |
) |
|
|
(34,436 |
) |
|
|
|
|
|
|
|
|
Net loss available to common stockholders |
|
$ |
(6,806 |
) |
|
$ |
(12,691 |
) |
|
$ |
(37,462 |
) |
|
$ |
(12,325 |
) |
|
$ |
(12,952 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
73,988 |
|
|
|
26,095 |
|
|
|
20,817 |
|
|
|
19,745 |
|
|
|
19,589 |
|
Diluted |
|
|
73,988 |
|
|
|
26,095 |
|
|
|
20,817 |
|
|
|
19,745 |
|
|
|
19,589 |
|
PER SHARE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
$ |
0.95 |
|
|
$ |
1.57 |
|
|
$ |
2.27 |
|
|
$ |
0.58 |
|
|
$ |
0.58 |
|
Net loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
(0.09 |
) |
|
|
(0.49 |
) |
|
|
(1.80 |
) |
|
|
(0.62 |
) |
|
|
(0.66 |
) |
Diluted |
|
|
(0.09 |
) |
|
|
(0.49 |
) |
|
|
(1.80 |
) |
|
|
(0.62 |
) |
|
|
(0.66 |
) |
Price: High |
|
|
6.61 |
|
|
|
4.91 |
|
|
|
4.30 |
|
|
|
2.35 |
|
|
|
4.00 |
|
Low |
|
|
3.01 |
|
|
|
2.17 |
|
|
|
2.00 |
|
|
|
0.45 |
|
|
|
0.60 |
|
BALANCE SHEET (000s) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
$ |
39,654 |
|
|
$ |
15,694 |
|
|
$ |
22,393 |
|
|
$ |
10,595 |
|
|
$ |
13,239 |
|
Net property, plant & equipment |
|
|
33,486 |
|
|
|
31,071 |
|
|
|
31,893 |
|
|
|
33,907 |
|
|
|
35,314 |
|
Total assets |
|
|
82,083 |
|
|
|
57,095 |
|
|
|
66,922 |
|
|
|
59,415 |
|
|
|
63,538 |
|
Current liabilities, including debt in default (5) |
|
|
10,253 |
|
|
|
15,460 |
|
|
|
11,160 |
|
|
|
11,959 |
|
|
|
43,803 |
|
Long-term obligations, less current installments (6) |
|
|
1,516 |
|
|
|
602 |
|
|
|
8,436 |
|
|
|
36,065 |
|
|
|
8,383 |
|
Shareholders equity |
|
|
70,314 |
|
|
|
41,033 |
|
|
|
47,326 |
|
|
|
11,391 |
|
|
|
11,352 |
|
CASH FLOW DATA (000s) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From operating activities |
|
$ |
2,509 |
|
|
$ |
(148 |
) |
|
$ |
(3,461 |
) |
|
$ |
(1,932 |
) |
|
$ |
9,357 |
|
From investing activities |
|
|
(4,377 |
) |
|
|
(1,857 |
) |
|
|
(838 |
) |
|
|
(1,743 |
) |
|
|
(5,315 |
) |
From financing activities |
|
|
22,895 |
|
|
|
(1,314 |
) |
|
|
8,191 |
|
|
|
3,529 |
|
|
|
(9,033 |
) |
Change in cash and cash equivalents |
|
|
21,027 |
|
|
|
(3,319 |
) |
|
|
3,892 |
|
|
|
(146 |
) |
|
|
(4,991 |
) |
|
|
|
(1) |
|
Operating loss includes the following (in thousands): (a) long-lived asset impairment charges
of (i) $2,037 in 2004, (ii) $2,362 in 2002. |
|
(2) |
|
Interest and other expense include the following (in thousands): (a) loss on Exchange
Transaction of $3,102 in 2003 and (b) dividends and discount accretion related to our Series A
Preferred Stock of $1,064 in 2004 and $589 in 2003. See Item 7. Managements Discussion and
Analysis of Financial Condition and Results of Operations Financial Conditions and
Liquidity. After the July 2004 shareholder approval relating to our Series A Preferred Stock,
such dividends and accretion did not impact net income (loss) but continued to impact earnings
(loss) per share until the Series A Preferred Stock was converted to shares of our common
stock on January 13, 2006. |
|
(3) |
|
Income tax provision (benefit) includes (in thousands) a $9,216 charge in 2002 to establish a
full valuation allowance against our net deferred income tax assets. Such net assets continued
to be fully offset by a valuation allowance. |
19
|
|
|
(4) |
|
Pursuant to the July 2004 shareholder approval that resulted in our Series A Preferred Stock
being recharacterized as equity rather than debt, dividends and adjustments related to our
preferred stock, while not impacting net loss, do result in increased losses available to
common stockholders when computing basic and diluted loss per share. A significant portion of
these adjustments for 2004 relate to accreting the carrying value of the preferred stock up to
its stated value. See Item 8. Financial Statements and Supplementary data Note H,
Preferred Stock. |
|
(5) |
|
Current liabilities include (in thousands) $3,250 and $35,565 of debt in default as of
December 31, 2004 and 2002 respectively. The 2002 debt was refinanced in 2003 as part of the
Exchange Transaction while the $3,250 debt was retired in 2005. See Item 7. Managements
Discussion and Analysis of Financial Condition and Results of Operations Financial
Conditions and Liquidity. |
|
(6) |
|
Long-term obligations include (in thousands) $21,132 of Series A Preferred Stock as of
December 31, 2003. Pursuant to the July 2004 shareholder approval relating to our Series A
Preferred Stock, these securities were reclassified into shareholders equity. |
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
RESULTS OF OPERATIONS
We added key management personnel, including a new vice president of global quality in 2005
and a new chief financial officer in 2004. Management has reduced our cost structure, improved our
processes and systems and implemented new controls over capital and operational spending. We
anticipate sales growth through internal product development efforts, additional contract services
opportunities which we are actively pursuing and ongoing progress we are seeing with our strategic
partners on new products development. Management believes these activities will improve our results
of operations, cash flow from operations and our future prospects.
Our revenues are derived from sales of diagnostic and therapeutic pharmaceuticals by our
ophthalmic segment, from sales of diagnostic and therapeutic pharmaceuticals by our hospital drugs
and injectables segment, and from contract services revenue.
The following table sets forth the percentage relationships that certain items from our
Consolidated Statements of Operations bear to revenues for the years ended December 31, 2006, 2005
and 2004.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended |
|
|
December 31, |
|
|
2006 |
|
2005 |
|
2004 |
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmic |
|
|
27 |
% |
|
|
51 |
% |
|
|
59 |
% |
Hospital Drugs & Injectables |
|
|
60 |
|
|
|
31 |
|
|
|
24 |
|
Contract Services |
|
|
13 |
|
|
|
18 |
|
|
|
17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
100 |
|
|
|
100 |
|
|
|
100 |
|
Gross profit |
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmic |
|
|
9 |
% |
|
|
18 |
% |
|
|
29 |
% |
Hospital Drugs & Injectables |
|
|
26 |
|
|
|
13 |
|
|
|
6 |
|
Contract Services |
|
|
3 |
|
|
|
3 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Gross Profit |
|
|
38 |
|
|
|
34 |
|
|
|
36 |
|
Selling, general and administrative expenses |
|
|
26 |
|
|
|
37 |
|
|
|
26 |
|
Amortization and write-downs of intangibles |
|
|
2 |
|
|
|
4 |
|
|
|
7 |
|
Research and development expenses |
|
|
17 |
|
|
|
10 |
|
|
|
4 |
|
Operating loss |
|
|
(7 |
) |
|
|
(17 |
) |
|
|
(1 |
) |
Net loss |
|
|
(8 |
)% |
|
|
(19 |
)% |
|
|
(6 |
)% |
COMPARISON OF TWELVE MONTHS ENDED DECEMBER 31, 2006 AND 2005
Consolidated revenues increased 60%, or $26,766,000 for the year ended December 31, 2006
compared to the prior year.
Ophthalmic segment revenues decreased 14%, or $3,131,000, primarily due to reduced sales of
diagnostic and anesthetic products. Hospital Drugs and Injectables segment revenues increased 210%
or $28,770,000 for the year, reflecting the increased volumes of
20
anesthesia and antidote products.
In particular, sales of $25,464,000 of DTPA radiation antidote products to HHS were a primary
driver for the sales increase in this category. This large order level for DTPA is not
expected to recur, although we do anticipate continued orders for this antidote product. Contract
services revenues increased by 14%, or $1,127,000, mainly due to increased order volumes on
contract products.
The chargeback and rebate expense, a component of net revenues, for the year ended December
31, 2006 increased to $26,295,000 from $24,391,000 in 2005, due to a general increase in the
product sales mix of higher chargeback and rebate percentage items along with increased price
competition. Note that sales of our DTPA antidote product to HHS were not subject to chargeback or
rebate expense.
Consolidated gross profit of $26,880,000 was 38% for 2006 as compared to a gross profit of
$14,944,000 or 34% for 2005. The gross profit of our ophthalmic segment decreased $2,000,000 or
25% due to a less favorable product mix and increased price competition. Our hospital drugs and
injectables segment gross profit increased $12,374,000 or 216% mainly due to sales of DTPA
radiation antidote products to HHS as noted above. Our contract services segment gross profit
improved $1,562,000 or 138% from the prior year mainly due to an improved sales mix combined with
process cost reductions.
Selling, general and administrative (SG&A) expenses increased 13%, to $18,603,000 for 2006
from $16,405,000 for 2005, mainly due to FAS 123R stock compensation expense of $1,229,000 in 2006,
increased FDA fees of $537,000 and consulting fees for Sarbanes-Oxley 404 implementation of
$435,000.
Research and development (R&D) expense increased significantly, by 162% in 2006, to
$11,797,000 from $4,510,000 for the year 2005, mainly due to R&D expenses related to lyophilization
testing and validation, clinical studies costs for our new ophthalmic anesthetic product (Akten)
and funding for product development with our strategic partners including costs for development of
an oral anti-infective product. We anticipate continued higher spending levels in our R&D for new
product development activities.
Interest expense decreased to $604,000 in 2006 from $2,325,000 in 2005, which represents a 74%
decrease. This decrease is primarily due to lower outstanding borrowings in 2006 as we paid off
debt and generated interest income in the latter part of 2006. This was partially offset by higher
interest rates in 2006.
Other income (expense) in 2006 was ($451,000) which was mainly due to an early debt retirement
fee of $391,000 to retire high-interest debt in the first quarter of 2006.
We recorded a valuation allowance to reduce the deferred income tax assets to the amount that
is more likely than not to be realized. Accordingly, the income tax expense (benefit) recorded for
2006 and 2005 represents various minimum federal/state income tax expenses.
As a result of the matters described above, net loss for 2006 was $5,963,000 versus a net loss
in 2005 of $8,609,000, a $2,646,000 decrease in loss. After consideration of preferred stock
dividends and adjustments in 2006 of $843,000 and 2005 of $4,082,000 related to specific accounting
for our preferred stock (see Item 8. Financial Statements and Supplementary Data, Note H
Preferred Stock), loss per share for 2006, on both a basic and diluted basis, was $0.09 on
weighted average shares outstanding of 73,988,000 compared to a basic and diluted loss per share
for 2005 of $0.49 on weighted average shares outstanding of 26,095,000.
COMPARISON OF TWELVE MONTHS ENDED DECEMBER 31, 2005 AND 2004
Consolidated revenues decreased 12% for the year ended December 31, 2005 compared to the prior
year.
Ophthalmic segment revenues decreased 24%, or $7,153,000, primarily due to reduced sales of
diagnostic and anesthetic products. Injectable segment revenues increased 11% or $1,378,000 for
the year, reflecting the increased volumes of anesthesia and antidote products. Contract services
revenues decreased by 5%, or $449,000, mainly due to lower volumes of contract research project
work.
The chargeback and rebate expense, a component of net revenues, for the year ended December
31, 2005 increased to $24,391,000 from $16,915,000 in 2004, due to a general increase in the
product sales mix of higher chargeback and rebate percentage items along with increased price
competition.
21
Consolidated gross profit of $14,944,000 was 34% for 2005 as compared to a gross profit of
$18,202,000 or 36% for 2004. The gross profit of our ophthalmic segment decreased $6,417,000 or
44% due to a less favorable product mix and increased price
competition. Our hospital drugs and injectables segment gross profit increased $2,452,000 or
75% due to a sales mix shift toward higher margin antidote products and additional manufacturing
volume efficiencies for these products. Our contract services segment gross profit improved
$707,000 or 165% from the prior year mainly due to a reduction in unfavorable plant manufacturing
variances at our Decatur manufacturing facility.
SG&A expenses increased 23%, to $16,405,000 for 2005 from $13,300,000 for 2004, due to the
2005 management bonuses ($1,479,000), reduced bad debt recoveries in 2005 ($777,000) and increased
FDA fees ($557,000).
Amortization and write-down of intangibles decreased by $1,901,000 due to an impairment charge
of $2,037,000 in 2004 related to product license intangible assets for Biolon, Erythromycin,
Cromolyn Sodium, AKWA Tears and Tears Renewed products. The carrying value of the intangible assets
for these products was reduced to zero in 2004.
R&D expense increased significantly, by 142% in 2005, to $4,510,000 from $1,861,000 for the
year ended December 31, 2004, mainly due to R&D expenses related to lyophilization validation
($1,073,000) and product development expenses for Akorn-Strides, LLC ($757,000). We anticipate
continued growth in our R&D spending for new product development activities.
Interest expense decreased to $2,325,000 in 2005 from $4,218,000 in 2004, which represents a
45% decrease. This decrease is primarily due to a decrease in Series A Preferred Stock interest
expense ($1,064,000) and a decrease in deferred financing for warrants ($874,000). The residual
difference is mainly due to lower outstanding borrowings in 2005 as a result of using a portion of
our Series B Preferred Stock issuance in August 2004 to pay down bank debt and retire a promissory
note held by NeoPharm, Inc. (NeoPharm) in 2005. This was partially offset by higher interest
rates in 2005.
Other income (expense) in 2005 was $1,212,000 due to gains related to retirement of the
promissory note held by NeoPharm. The gain of $1,562,000 in 2004 was mainly the result of
settlements of disputes which resulted in a gain on the sale of our investment in Novadaq
Technologies, Inc. (Novadaq) and a lower than accrued payout on a prior dispute settlement. See
Item 8. Financial Statements and Supplementary Data, Note E Investment in Novadaq Technologies.
We recorded a valuation allowance to reduce the deferred income tax assets to the amount that
is more likely than not to be realized. Accordingly, the income tax expense (benefit) recorded for
2005 and 2004 represents various minimum federal/state income tax expenses.
As a result of the matters described above, net loss for 2005 was $8,609,000 versus a net loss
in 2004 of $3,026,000, a $5,583,000 increase in loss. After consideration of preferred stock
dividends and adjustments in 2005 of $4,082,000 and 2004 of $34,436,000 related to specific
accounting for our preferred stock (see Item 8. Financial Statements and Supplementary Data, Note H
Preferred Stock), loss per share for 2005, on both a basic and diluted basis, was $0.49 on
weighted average shares outstanding of 26,095,000 compared to a basic and diluted loss per share
for 2004 of $1.80 on weighted average shares outstanding of 20,817,000.
FINANCIAL CONDITION AND LIQUIDITY
Overview
As a result of the factors outlined above, we have experienced losses from operations in 2006
and 2005 of $4,905,000 and $7,479,000, respectively and the net losses for these years were
$5,963,000 and $ 8,609,000, respectively.
As of December 31, 2006, we had cash and cash equivalents of $21,818,000. Our net working
capital at December 31, 2006 was $29,401,000 versus a net working capital of $234,000 at December
31, 2005, resulting primarily from the increased cash levels from stock issuances and the decrease
in debt as we retired our major debt instruments in the first quarter of 2006 (see discussion
below). This reduced current debt by $6,650,000 from the prior year level.
During the year ended December 31, 2006, we generated $2,509,000 in cash from operations as
the net loss was offset by non-cash expenses of $6,379,000 for the period, a $785,000 change in
working capital items and a $1,308,000 increase in the product warranty reserve related to our DTPA
antidote product (see Critical Accounting Policies below). During 2005, we used $148,000 in cash
from operations as the net loss was offset by $6,957,000 in non-cash expenses and a $2,966,000
reduction in working capital items
22
(mainly attributable to lower receivables with wholesalers)
while the non-cash gain on retirement of debt reduced the operating cash flow. Investing activities
for 2006 generated a $4,377,000 reduction in cash flow mainly due to capital expenditures for
production
equipment. Investing activities during 2005 required $1,857,000 in cash and included
$1,782,000 of property, plant, and equipment additions to our lyophilization facility and other
manufacturing equipment in 2005. Financing activities for 2006 provided $22,895,000 in cash
primarily due to the $18,078,000 net proceeds from the March 2006 common stock and warrants
offering and an additional $3,543,000 from the September 2006 private placement with Serum.
Financing activities for 2005 used $1,314,000 in cash primarily due to the $2,500,000 payment to
retire the NeoPharm promissory note offset by $1,556,000 received from the sale of stock and
exercise of warrants.
On October 7, 2003, a group of investors (the Investors) purchased all of our then
outstanding senior bank debt from The Northern Trust Company (Northern Trust), a balance of
$37,731,000, at a discount and exchanged such debt with us (the Exchange Transaction) for (i)
257,172 shares of our Series A Preferred Stock, (ii) subordinated promissory notes in the aggregate
principal amount of approximately $2,767,000 (the 2003 Subordinated Notes), (iii) warrants to
purchase an aggregate of 8,572,400 shares of our common stock with an exercise price of $1.00 per
share (Series A Warrants), and (iv) $5,473,862 in cash from the proceeds of the term loan under
the Credit Facility described in a following paragraph. The 2003 Subordinated Notes and cash were
issued by us to (a) The John N. Kapoor Trust dated 9/20/89 (the Kapoor Trust), the sole trustee
and sole beneficiary of which is Dr. John N. Kapoor, our chairman of the board of directors and the
holder of a significant stock position in Akorn, (b) Arjun Waney, a holder of a significant stock
position in Akorn, and (c) Argent Fund Management Ltd., for which Mr. Waney serves as Chairman and
Managing Director and 52% of which is owned by Mr. Waney. We also issued warrants (Note Warrants)
to the holders of the 2003 Subordinated Notes to purchase an aggregate of 276,714 shares of common
stock with an exercise price of $1.10 per share and paid a portion of the legal fees of the
Investors.
Simultaneously with the consummation of the Exchange Transaction, we entered into a credit
agreement with LaSalle Bank National Association (LaSalle Bank) providing us with two term loans
(collectively, the Term Loans) which consisted of a $5,500,000 term loan A, and a $1,500,000 term
loan B, totaling $7,000,000, and a revolving line of credit of up to $5,000,000 (the Revolver) to
provide for working capital needs (the Credit Facility) secured by substantially all of our
assets. Our obligations under the Credit Facility were guaranteed by the Kapoor Trust and Mr.
Waney. In exchange for this guaranty, we issued additional warrants (the Guaranty Warrants) to
purchase 880,000 and 80,000 shares of common stock to the Kapoor Trust and Mr. Waney, respectively,
with an exercise price of $1.10 per share. Such guarantees have since been released by LaSalle
Bank.
On August 23, 2004, we completed a private placement of 141,000 shares of our Series B
Preferred Stock at a price of $100 per share, convertible into common stock at a price of $2.70 per
share, with warrants to purchase 1,566,667 additional shares of our common stock exercisable until
August 23, 2009, with an exercise price of $3.50 per share (Series B Warrants). The net proceeds
to us after payment of investment banker fees and expenses and other transaction costs of
approximately $1,056,000 were approximately $13,044,000.
A portion of the net proceeds of the private placement of the Series B Preferred Stock paid
off the outstanding debt from LaSalle Bank. The remainder of the net proceeds was used for working
capital, payment of the NeoPharm promissory note, validation and testing of our new lyophilization
facility and general corporate purposes.
An additional common stock private placement offering was completed on March 8, 2006 which
yielded net proceeds to us of approximately $18,078,000 which was used to reduce debt and fund
additional product development activities and build a fund for future product development spending.
On March 20, 2006 we retired the 2003 Subordinated Notes for a cash payment of $3,288,000 which
included principal and interest. In September 2006, we issued 1,000,000 shares of our common stock
in a private placement with Serum at a price of $3.56 per share. The offering price was $3,560,000
and the net proceeds to us, after payment of approximately $17,000 in expenses, were approximately
$3,543,000.
As of December 31, 2006, we had approximately $ 21,818,000 in cash and approximately
$7,369,000 of undrawn availability under the Credit Facility with LaSalle Bank. We believe that our
realigned balance sheet, access to our line of credit and capital markets and our cash flows from
operations will be sufficient to operate our business for the next twelve months.
Facility Expansion
We are in the final stages 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.
23
As of December 31, 2006, we had spent approximately $22,433,000 on the lyophilization
expansion and anticipate the need to spend approximately $200,000 of additional funds to complete
the expansion related to the lyophilization equipment. These
additional funds will primarily be used for testing and validation as the major capital equipment
items are currently in place. In December 2006, we placed the building and sterile solutions
portion of this operation ($17,237,000) in service which augments our existing production
capacities. The remaining $5,196,000 of construction in progress, which is specific to
lyophilization (freeze-dry) operations, is awaiting final review and a PAI by the FDA for us to
place this equipment into commercial production. We anticipate the PAI review in the first half of
2007. In addition, we are working toward the development of an internal ANDA lyophilized product
pipeline for these operations.
Credit Facility
As stated above, and further described in Item 8. Financial Statements and Supplementary Data,
Note G Financing Arrangements, we entered into a Credit Facility with LaSalle Bank in 2003. The
Credit Facility included the Term Loans, as well as the Revolver secured by substantially all of
our assets. The Credit Facility will mature on September 30, 2008. The Term Loans carried interest
at prime plus 1.75% and required principal payments of $195,000 per month commencing October 31,
2003, with the payments first to be applied to term loan B. The Revolver bears interest at prime
plus 0.50 % (previously prime plus 1.50%). The Term Loans were paid off with the proceeds from our
Series B Preferred Stock offering in August 2004 and we had a zero balance on the Revolver at
December 31, 2006.
Availability under the Revolver is determined by the sum of (i) 80% of eligible accounts
receivable, (ii) 50% of raw material, finished goods and component inventory excluding packaging
items, not to exceed $5,000,000, and (iii) the difference between 90% of the forced liquidation
value of machinery and equipment ($4,092,000) and the sum of $1,750,000 and the outstanding balance
under term loan B (the term B loan was retired in August 2004). The Credit Facility contains
certain restrictive covenants including but not limited to certain financial covenants such as
EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) to interest expense and
Senior Debt to EBITDA ratios. If we are not in compliance with the covenants of the Credit
Facility, LaSalle Bank has the right to declare an event of default and all of the outstanding
balances owed under the Credit Facility would become immediately due and payable. The Credit
Facility also contains subjective covenants providing that we would be in default if, in the
judgment of the lenders, there is a material adverse change in our financial condition. We
negotiated an amendment to the Credit Facility effective December 31, 2003 that clarified certain
covenant computations and waived certain technical violations. Because the Credit Facility also
requires us to maintain our deposit accounts with LaSalle, the existence of these subjective
covenants, pursuant to EITF Abstract No. 95-22, require that we classify outstanding borrowings
under the Revolver as a current liability (zero as of December 31, 2006).
On August 13, 2004, we entered into the First Amendment to the Credit Facility (the First
Amendment). Among other things, the First Amendment amended certain of our financial covenants and
LaSalle Bank agreed to waive certain events of default arising out of our noncompliance with
certain of our obligations. Certain financial conditions in the Kapoor Trust guaranty were also
amended as a result of the First Amendment.
On August 26, 2004, we entered into the Second Amendment to the Credit Facility (the Second
Amendment), which released the Kapoor Trust guaranty and eliminated certain event of default
provisions that were related to the Kapoor Trust guaranty. In addition, on August 27, 2004, LaSalle
Bank cancelled each of the irrevocable standby letters of credit posted by Dr. Kapoor and Mr.
Waney.
On October 8, 2004, we entered into the Third Amendment to the Credit Facility (the Third
Amendment) which waived events of default associated with the warrants issuance to AEG Partners,
LLC (see Preferred Stock and Warrants discussion below) and the NeoPharm promissory note default
(discussed below). In addition, the Third Amendment amended definitions of the Computation Period
and EBITDA to Interest Expense Ratio for covenant calculations.
On September 30, 2005, we entered into the Fourth Amendment to Credit Facility, (the Fourth
Amendment) which, among other things, extended the term through September 30, 2008 and increased
the revolving commitment amount under the Credit Facility from $5,000,000 to $10,000,000.
On March 1, 2006, a subsequent Amendment, Waiver and Consent to Credit Agreement was made
effective which adjusted the Credit Facility debt covenant computations for the periods ended
December 31, 2005 and March 31, 2006. The revisions adjusted the defined EBITDA for certain R&D
expenses and the interest coverage formula to exclude interest paid on the NeoPharm promissory note
retirement and thereby resolved a default on the debt covenants of the Credit facility at December
31, 2005. In addition it provided consent for the private placement of common stock in March of
2006 and waived certain defaults therefrom.
24
On March 5, 2007, another Amendment, Waiver and Consent to Credit Agreement was made effective
which adjusted the Credit Facility debt covenant computations for the periods ended December 31,
2006 and beyond. The revisions adjusted the defined EBITDA for certain R&D expense levels and
waived defaults prior to this revision.
Subordinated Debt
In 2001, we entered into a $5,000,000 convertible subordinated debt agreement including a
$3,000,000 Tranche A note (Tranche A Note) and a $2,000,000 Tranche B note (Tranche B Note)
with the Kapoor Trust (collectively, the Convertible Note Agreement). Under the terms of the
Convertible Note Agreement, both Tranche A Note and Tranche B Note, which were due December 20,
2006, bore interest at prime plus 3% and were issued with detachable warrants (the Tranche A
Warrants and the Tranche B Warrants) to purchase shares of common stock. Interest payments were
prohibited under the terms of a subordination arrangement. The convertible feature of the
Convertible Note Agreement, as amended, allowed for conversion of the subordinated debt plus
interest into our common stock, at a price of $2.28 per share of common stock for Tranche A and
$1.80 per share of common stock for Tranche B. The Company negotiated an early settlement of the
Tranche A Note and the Tranche B Note in March 2006. The associated principal and accumulated
interest of approximately $7,298,000 was retired by conversion into 3,540,281 shares of the
Companys common stock on March 31, 2006. A debt retirement fee of approximately $391,000 was paid
as an inducement to retire these notes prior to the original maturity date of December 20, 2006.
In December 2001, we entered into a $3,250,000 five-year loan (the NeoPharm Note) with
NeoPharm to fund the completion our lyophilization facility located in Decatur, Illinois. Dr.
Kapoor, our chairman, is also a director of NeoPharm and holds a substantial stock position in
NeoPharm, as well as in Akorn. Under the terms of the NeoPharm Note evidencing the loan, interest
accrued at the initial rate of 3.6% to be reset quarterly based upon NeoPharms average return on
its cash and readily tradable long and short-term securities during the previous calendar quarter.
In consideration for the loan, under a separate processing agreement between us and NeoPharm, we
agreed to provide NeoPharm with access to at least 15% of the capacity of its lyophilization
facility each year upon completion of the lyophilization facility.
The NeoPharm Note was subordinate to our senior debt owed to LaSalle Bank but was senior to
the subordinated debt owed to the Kapoor Trust. On October 6, 2004, we received a notice from
NeoPharm indicating that an event of default had occurred on the NeoPharm Note. The notice stated
that an event of default was triggered when the processing agreement between NeoPharm and Akorn,
which was contractually obligated to go into effect on or before October 1, 2004, failed to occur.
The processing agreement failed to become effective, in part, because of our inability to remove
the sanctions imposed by the FDA on our Decatur manufacturing facility.
The event of default under the NeoPharm Note also triggered a cross-default provision under
the Convertible Note Agreement. The Kapoor Trust waived the cross-default. Because of this
default, we recorded the $3,250,000 of debt and $362,000 of accrued interest as current obligations
as of December 31, 2004. On May 16, 2005, we paid all principal and interest due under the NeoPharm
Note with a one-time cash payment of $2,500,000 and terminated the processing agreement between
NeoPharm and us. On May 13, 2005, we entered into a Waiver and Consent to Credit Agreement with
LaSalle Bank pursuant to which LaSalle Bank agreed to waive events of default arising out of our
noncompliance with our obligations under the Credit Facility resulting from our pay-off of the
NeoPharm Note.
As part of the Exchange Transaction, we issued the 2003 Subordinated Notes to the Kapoor
Trust, Arjun Waney and Argent Fund Management, Ltd. The 2003 Subordinated Notes were to mature on
April 7, 2006 and bore interest at prime plus 1.75%. On March 20, 2006 the Company retired the
2003 Subordinated Notes with a cash payment of $3,288,000 which included the original $2,767,000
principal balance plus the accrued interest up to the date of payment.
Other Indebtedness
In June 1998, we entered into a $3,000,000 mortgage agreement with Standard Mortgage
Investors, LLC, of which there were outstanding borrowings of $602,000 and $938,000 at December 31,
2006 and 2005, respectively. The principal balance is payable over 10 years, with the final payment
due in June 2008. The mortgage note bears a fixed interest rate of 7.375% and is secured by the
real property located in Decatur, Illinois.
The fair value of the debt obligations approximated the recorded value as of December 31,
2006.
25
Preferred Stock and Warrants
Series A Preferred Stock
Prior to its conversion, the Series A Preferred Stock accrued dividends at a rate of 6.0% per
annum, which rate was fully cumulative, accrued daily and compounded quarterly. While the dividends
could have been paid in cash at our option, such dividends were being deferred and were converted
into our common stock. All shares of Series A Preferred Stock had liquidation rights in preference
over junior securities, including the common stock, and had certain anti-dilution protections. The
Series A Preferred Stock and unpaid dividends were convertible at any time into a number of shares
of common stock equal to the quotient obtained by dividing (x) $100 per share plus any accrued but
unpaid dividends on that share by (y) $0.75, as such numbers could be adjusted from time to time
pursuant to the terms of the Restated Articles of Incorporation. All shares of Series A Preferred
Stock were to convert to shares of common stock on the earlier to occur of (i) October 8, 2006 and
(ii) the date on which the closing price per share of common stock for at least 20 consecutive
trading days immediately preceding such date exceeds $4.00 per share. Until our shareholders
approved certain provisions regarding the Series A Preferred Stock (the Stockholders Approval),
which occurred in July 2004, the Series A Preferred Stock was also redeemable in October 2011.
Holders of Series A Preferred Stock had full voting rights, with each holder entitled to a number
of votes equal to the number of shares of common stock into which its shares could be converted.
The initial amount recorded for the Series A Preferred Stock, as described in Item 8.
Financial Statements and Supplementary Data, Note H Preferred Stock, was $5,174,000 below its
stated value. Until the July 8, 2004 Stockholders Approval date we had been accreting this
difference over the time period from issuance to the mandatory redemption date in October 2011.
Accretion was $267,000 in 2004 and $220,000 in 2003.
Pursuant to FASB No. 150 Accounting for Certain Financial Instruments with Characteristics
of Both Liabilities and Equity, as amended, the Series A Preferred Stock was originally reflected
as a liability because of its mandatory redemption feature. That characterization remained through
July 8, 2004 and as such, dividends have been reflected as interest expense in the statement of
operations through July 8, 2004. As a result of the Stockholders Approval on July 8, 2004, the
carrying value of the Series A Preferred Stock was reclassified into shareholders equity and
future dividends are reflected as adjustments to accumulated deficit and are shown in the financial
statements as impacting income (loss) available to common stockholders. Additionally, and in
accordance with EITF Abstract No. 00-27, we also recorded in July 2004 the value of the conversion
option imbedded at issuance in each share of Series A Preferred Stock, subject to limitations
described in the EITF. That value, approximately $20,874,000, reduced the carrying value of the
Series A Preferred Stock to near zero with the offsetting excess to common stock. The carrying
value of the Series A Preferred Stock was then adjusted to its full aggregated stated value, plus
unpaid dividends (approximately $26,552,000) with a charge directly to accumulated deficit. That
charge did not impact net earnings for the third quarter of 2004, but substantially reduced
earnings available to common stockholders and generated a loss per share for that period.
Effective as of January 13, 2006, pursuant to the automatic conversion provisions set forth in
our Restated Articles of Incorporation, all 241,122 outstanding shares of Series A Preferred Stock
immediately and automatically converted into an aggregate of 36,796,755 shares of our common stock,
no par value.
As set forth in our Restated Articles of Incorporation, all outstanding shares of Series A
Preferred Stock immediately and automatically converted into shares of our common stock on the day
after the closing price per share of the common stock exceeded $4.00 for 20 consecutive trading
days. The closing price per share of the Common Stock as reported on the American Stock Exchange
exceeded $4.00 for 20 consecutive trading days as of the close of the market on January 12, 2006.
Consequently, all outstanding shares of Series A Preferred Stock automatically converted into
shares of our common stock on January 13, 2006. No shares of Series A Preferred Stock remain
outstanding. Akorn received no consideration in connection with the automatic conversion.
Series B Preferred Stock
On August 23, 2004, we issued an aggregate of 141,000 shares of Series B Preferred Stock at a
price of $100 per share, convertible into common stock at a price of $2.70 per share, to certain
investors, with Series B Warrants to purchase 1,566,667 additional shares of common stock
exercisable until August 23, 2009, with an exercise price of $3.50 per share. The net proceeds to
us after payment of investment banker fees and expenses and other transaction costs of
approximately $1,056,000 were approximately $13,044,000. A portion of the proceeds was used to pay
off the Term Loans and reduce the Revolver to zero. That early pay down and resulting elimination
of certain personal guarantees of that debt resulted in the write-off of $245,000 of unamortized
deferred financing fees. Remaining proceeds were used for working capital and other general
corporate purposes, including validation testing of our
26
lyophilization facility. In accounting for
the issuance of the Series B Preferred Stock and Series B Warrants, we recorded additional
charges directly to accumulated deficit of $5,998,000. That charge did not impact net earnings
for the third quarter, but substantially reduced earnings available to common stockholders and
earnings per share for that period.
Prior to its conversion, the Series B Preferred Stock accrued dividends at a rate of 6.0% per
annum, which rate was fully cumulative, accrued daily and compounded quarterly. While the dividends
could be paid in cash at our option, such dividends were deferred and added to the Series B
Preferred Stock balance. Each share of our Series B Preferred Stock, and accrued and unpaid
dividends with respect to each such share, was convertible by the holder thereof at any time into a
number of shares of our common stock equal to the quotient obtained by dividing (x) $100 plus any
accrued but unpaid dividends on such share by (y) $2.70, as such numerator and denominator could be
adjusted from time to time pursuant to the anti-dilution provisions of our Restated Articles of
Incorporation governing the Series B Preferred Stock. We had the option of converting all shares of
Series B Preferred Stock into shares of our common stock on any date after August 23, 2005 as to
which the closing price per share of the common stock for at least 20 consecutive trading days
immediately preceding such date exceeded $5.00 per share.
As required under the terms of the Series B Preferred Stock transaction, we completed the
registration with the SEC of the common shares into which the Series B Preferred Stock is
convertible in October 2004, among others. Had the registration statement not become effective
within 270 days from August 23, 2004, each holder would have had the right to compel us to purchase
its shares of Series B Preferred Stock for cash in an amount equal to $115 per share (the Put
Option). As a result of the Put Option, and pursuant to SEC rules and regulations, our Series B
Preferred Stock was reflected outside of the shareholders equity section of our consolidated
balance sheet until the registration statement became effective. Due to that registration, the
holders of the Series B Preferred Stock could no longer put their shares back to us, and
accordingly, the Series B Preferred Stock was reclassified into equity in October 2004.
Immediately after the private placement of the Series B Preferred Stock, the purchasers of
Series B Preferred Stock held approximately 31% of the aggregate voting rights represented by
outstanding shares of common stock and Series B Preferred Stock. Immediately after the Series B
Preferred Stock private placement and assuming the exercise of all outstanding conversion rights,
warrants and options to acquire common stock, the purchasers of Series B Preferred Stock would hold
approximately 9% of the common stock, on a fully-diluted basis. Prior to the Series B Preferred
Stock private placement, the purchasers of Series B Preferred Stock held approximately 5% of the
outstanding voting securities and would have held approximately 18% of the common stock on a
fully-diluted basis.
All outstanding shares of our Series B Preferred Stock were to immediately and automatically
convert into shares of common stock on the day after the closing price per share of the common
stock exceeded $5.00 for 20 consecutive trading days and this occurred as of the close of the
market on the American Stock Exchange on December 13, 2006. Consequently, all 66,000 outstanding
shares of Series B Preferred Stock immediately and automatically converted into an aggregate of
2,804,800 shares of common stock on December 14, 2006. As of December 31, 2006, no shares of
Series B Preferred Stock remain outstanding. Akorn received no consideration in connection with the automatic conversion.
Warrants
The Series A Warrants issued in connection with the Exchange Transaction for 8,572,400 shares
of common stock at an exercise price of $1.00 per share were exercisable at any time prior to
expiration on October 7, 2006. The Guaranty Warrants for 960,000 shares of common stock at an
exercise price of $1.10 per share were issued in consideration of the debt guaranty as part of the
Exchange Transaction. Also, as part of the Exchange Transaction, we issued the Note Warrants for
276,714 shares of common stock at an exercise price of $1.10 per share. In addition, there were
Tranche A Warrants and Tranche B Warrants that were outstanding prior to the Exchange Transaction
for 1,000,000 and 667,000 shares of common stock with per share exercise prices of $2.85 and $2.25,
respectively. As of December 31, 2006, all of the outstanding Series A Warrants, Guaranty
Warrants, Note Warrants, Tranche A, and Tranche B Warrants were exercised.
The Series B Warrants are exercisable at any time prior to expiration on August 23, 2009. The
warrants for 1,566,667 shares of common stock were issued on August 23, 2004 and have an exercise
price of $3.50 per share. As of December 31, 2006, 555,555 warrants were exercised. As of
December 31, 2006, there were 1,011,112 outstanding Series B Warrants.
As further described in Item 8. Financial Statements and Supplemental Data, Note N
Commitments and Contingencies, we have issued to AEG Partners, LLC (AEG) warrants (the AEG
Warrants) to purchase 1,250,000 shares of our common stock at an exercise price of $0.75 per
share. AEG exercised 200,000 of the AEG Warrants during 2006 and 800,000 AEG Warrants remain
outstanding as of December 31, 2006.
27
On March 8, 2006 we issued 4,311,669 shares of our common stock in a private placement with
various investors at a price of $4.50 per share which included warrants to purchase 1,509,088
additional shares of common stock. The warrants are exercisable for a five year period at an
exercise price of $5.40 per share and may be exercised by cash payment of the exercise price or by
means of a cashless exercise. The aggregate offering price of the private placement was
approximately $19,402,000 and the net proceeds to us, after payment of approximately $1,324,000 of
commissions and expenses, was approximately $18,078,000. The net proceeds were allocated based on
the relative fair market values of the common stock and warrants with $16,257,000 allocated to the
common stock and $1,821,000 allocated to the warrants.
CONTRACTUAL OBLIGATIONS
(In Thousands)
The following table details our future contractual obligations as of December 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment Due by Period |
|
|
More than |
|
Description |
|
Total |
|
|
Less than 1 year |
|
|
1-3 years |
|
|
3-5 years |
|
|
5 years |
|
Current and Long Term-Debt |
|
$ |
602 |
|
|
$ |
394 |
|
|
$ |
208 |
|
|
$ |
|
|
|
$ |
|
|
Operating Leases |
|
|
10,635 |
|
|
|
1,125 |
|
|
|
2,375 |
|
|
|
2,416 |
|
|
|
4,719 |
|
Interest Payments on Debt |
|
|
35 |
|
|
|
31 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total: |
|
$ |
11,272 |
|
|
$ |
1,550 |
|
|
$ |
2,587 |
|
|
$ |
2,416 |
|
|
$ |
4,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
In Thousands, Except Per Share Amounts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income (Loss) |
|
|
|
|
|
|
Gross |
|
|
|
|
|
Per Share |
|
Per Share |
|
|
Revenues |
|
Profit |
|
Amount |
|
Basic |
|
Diluted |
Year Ended December 31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1st Quarter |
|
$ |
29,730 |
|
|
$ |
11,733 |
|
|
$ |
3,126 |
|
|
$ |
0.05 |
|
|
$ |
0.04 |
|
2nd Quarter |
|
|
12,475 |
|
|
|
4,955 |
|
|
|
(1,963 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
3rd Quarter |
|
|
14,490 |
|
|
|
5,951 |
|
|
|
(1,067 |
) |
|
|
(0.02 |
) |
|
|
(0.02 |
) |
4th Quarter |
|
|
14,555 |
|
|
|
4,241 |
|
|
|
(6,059 |
) |
|
|
(0.07 |
) |
|
|
(0.07 |
) |
Year Ended December 31, 2005: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1st Quarter |
|
$ |
10,181 |
|
|
$ |
3,343 |
|
|
$ |
(2,287 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.13 |
) |
2nd Quarter |
|
|
12,578 |
|
|
|
4,852 |
|
|
|
(67 |
) |
|
|
(0.04 |
) |
|
|
(0.04 |
) |
3rd Quarter |
|
|
10,985 |
|
|
|
3,668 |
|
|
|
(2,614 |
) |
|
|
(0.14 |
) |
|
|
(0.14 |
) |
4th Quarter |
|
|
10,740 |
|
|
|
3,081 |
|
|
|
(3,641 |
) |
|
|
(0.18 |
) |
|
|
(0.18 |
) |
CRITICAL ACCOUNTING POLICIES
Revenue Recognition
We recognize product sales for our ophthalmic and hospital drugs and injectables business
segments upon the shipment of goods or upon the delivery of goods, depending on the sales terms.
The contract services segment, which produces products for third party customers, based upon their
specification, at a pre-determined price, also recognizes sales upon the shipment of goods or upon
delivery of the product or service as appropriate. Revenue is recognized when all of our
obligations have been fulfilled and collection of the related receivable is probable. Provision for
estimated doubtful accounts, chargebacks, rebates, discounts and product returns is made at the
time of sale and is analyzed and adjusted, if necessary, at each balance sheet date.
Allowance for Chargebacks and Rebates
We enter into contractual agreements with certain third parties such as hospitals and
group-purchasing organizations to sell certain products at predetermined prices. The parties have
elected to have these contracts administered through wholesalers that buy the product from us and
subsequently sell it to those third parties. When a wholesaler sells products to one of the third
parties that are subject to a contractual price agreement, the difference between the price paid to
us by the wholesaler and the price under the specific contract is charged back to us by the
wholesaler. We track sales and submitted chargebacks by product number and contract for each
28
wholesaler. Utilizing this information, we estimate a chargeback percentage for each product. We
reduce gross sales and increase the
chargeback allowance by the estimated chargeback amount for each product sold to a wholesaler.
We reduce the chargeback allowance when we process a request for a chargeback from a wholesaler.
Actual chargebacks processed can vary materially from period to period based upon actual sales
volume through the wholesalers. However, our provision for chargebacks is fully reserved for at the
time when sales revenues are recognized.
We obtain certain wholesaler inventory reports to aid in analyzing the reasonableness of the
chargeback allowance that will be paid out in the future. We assess the reasonableness of our
chargeback allowance by applying the product chargeback percentage based on historical activity to
the quantities of inventory on hand per the wholesaler inventory reports and an estimate of
in-transit inventory that is not reported on the wholesaler inventory reports at the end of the
period. In accordance with our accounting policy, our estimate of the percentage amount of
wholesaler inventory that will ultimately be sold to a third party that is subject to a contractual
price agreement is based on a six-quarter trend of such sales through wholesalers. We use this
percentage estimate (95% as of December 31, 2006) until historical trends or new information
indicate that a revision should be made. On an ongoing basis, we evaluate our actual chargeback
rate experience and new trends are factored into our estimates each quarter as market conditions
change. In the first quarter of 2004, we obtained more precise information from the wholesalers to
estimate the amount of in-transit inventory, which lowered our estimate of in-transit inventory.
This resulted in us recognizing approximately $500,000 less in chargeback expense in the first
quarter of 2004. We have used this new information on a going forward basis as a more accurate
estimate of in-transit inventory. Additionally, in the second quarter of 2004, we, in accordance
with our policy, reduced our estimate of the percentage amount of wholesaler inventory that will
ultimately be sold to a third party that is subject to a contractual price agreement. This
reduction was made in reaction to a six-quarter trend of such sales being below our previous
estimates, thereby confirming that the reduced percentage was other than temporary. This estimate
change resulted in approximately $480,000 less in chargeback expense in the second quarter of 2004.
In the fourth quarter of 2005, we reviewed our sales trends through wholesalers and revised the
estimated percentage amount of wholesaler inventory that will ultimately be sold to a third party
that is subject to a contractual price agreement which resulted in a $408,000 increase in
chargeback expense in the fourth quarter 2005. We again reviewed and revised this same percentage
estimate in the fourth quarter of 2006 which resulted in a $446,000 increase in the chargeback
expense in the fourth quarter of 2006. We intend to use this revised estimate on a going forward
basis until historical trends indicate that additional revisions should be made.
Similarly, we maintain an allowance for rebates related to fee for service contracts and other
programs with certain customers. Rebate percentages vary by product and by volume purchased by each
eligible customer. We track sales by product number for each eligible customer and then apply the
applicable rebate percentage, using both historical trends and actual experience to estimate our
rebate allowance. We reduce gross sales and increase the rebate allowance by the estimated rebate
amount when we sell our products to our rebate-eligible customers. We reduce the rebate allowance
when we process a customer request for a rebate. At each balance sheet date, we analyze the
allowance for rebates against actual rebates processed and make necessary adjustments as
appropriate. Actual rebates processed can vary materially from period to period. However, our
provision for rebates is fully reserved for at the time when sales revenues are recognized.
The recorded allowances reflect our current estimate of the future chargeback and rebate
liability to be paid or credited to our wholesaler and other customers under the various contracts
and programs. For the years ended December 31, 2006, 2005, and 2004, we recorded chargeback and
rebate expense of $26,295,000, $24,391,000 and $16,915,000, respectively. The allowance for
chargebacks and rebates was $8,370,000 and $7,634,000 as of December 31, 2006 and 2005,
respectively.
Allowance for Product Returns
Certain of our products are sold with the customer having the right to return the product
within specified periods and guidelines for a variety of reasons, including but not limited to
pending expiration dates. Provisions are made at the time of sale based upon tracked historical
experience, by customer in some cases. In evaluating month-end allowance balances, we consider
actual returns to date that are in process, the expected impact of product recalls and the
wholesalers inventory information to assess the magnitude of unconsumed product that may result in
a product return to us in the future. We estimate our sales returns reserve based on a historical
percentage of returns to sales utilizing a twelve month look back period. One-time historical
factors or pending new developments that would impact the expected level of returns are taken into
account to determine the appropriate reserve estimate at each balance sheet date. The sales
returns level can be impacted by factors such as overall market demand and market competition and
availability for substitute products which can increase or decrease the end-user pull through for
sales of our products and ultimately impact the level of sales returns. Actual returns experience
and trends are factored into our estimates each quarter as market conditions change.
29
Actual
returns processed can vary materially from period to period. For the years ended December 31, 2006,
2005, and 2004, we
recorded a provision for product returns of $3,861,000, $3,122,000 and $1,956,000,
respectively. The allowance for potential product returns was $2,437,000 and $1,529,000 at December
31, 2006 and 2005, respectively.
Allowance for Doubtful Accounts
Provisions for doubtful accounts, which reflect trade receivable balances owed to us that are
believed to be uncollectible, are recorded as a component of SG&A expenses. In estimating the
allowance for doubtful accounts, we have:
|
|
|
Identified the relevant factors that might affect the accounting estimate for allowance
for doubtful accounts, including: (a) historical experience with collections and write-offs;
(b) credit quality of customers; (c) the interaction of credits being taken for discounts,
rebates, allowances and other adjustments; (d) balances of outstanding receivables, and
partially paid receivables; and (e) economic and other exogenous factors that might affect
collectibility (e.g., bankruptcies of customers, channel factors, etc.). |
|
|
|
|
Accumulated data on which to base the estimate for allowance for doubtful accounts,
including: (a) collections and write-offs data; (b) information regarding current credit
quality of customers; and (c) information regarding exogenous factors, particularly in
respect of major customers. |
|
|
|
|
Developed assumptions reflecting our judgments as to the most likely circumstances and
outcomes, regarding, among other matters: (a) collectibility of outstanding balances
relating to partial payments; (b) the ability to collect items in dispute (or subject to
reconciliation) with customers; and (c) economic and other exogenous factors that might
affect collectibility of outstanding balances based upon information available at the
time. |
For the years ended December 31, 2006, 2005, and 2004, we recorded a net expense/(benefit) for
doubtful accounts of ($150,000), $74,000, and ($43,000), respectively. The 2005 expense was mainly
due to one uncollectible account while the favorable experience in 2006 and 2004 was due to
recoveries and reduced reserve requirements which exceeded write offs and reduced previously
identified collectibility concerns. The allowance for doubtful accounts was $3,000 and $13,000 as
of December 31, 2006 and 2005, respectively. As of December 31, 2006, we had a total of $ 196,000
of past due gross accounts receivable, of which $54,000 was over 60 days past due. We perform
monthly a detailed analysis of the receivables due from our wholesaler customers and provide a
specific reserve against known uncollectible items for each of the wholesaler customers. We also
include in the allowance for doubtful accounts an amount that we estimate to be uncollectible for
all other customers based on a percentage of the past due receivables. The percentage reserved
increases as the age of the receivables increases.
Allowance for Discounts
Cash discounts are available to certain customers based on agreed upon terms of sale. We
evaluate the discount reserve balance against actual discounts taken. For the years ended December
31, 2006, 2005, and 2004, we recorded a provision for discounts of $1,595,000, $1,003,000 and
$925,000 respectively. The allowance for discounts was $236,000 and $244,000 as of December 31,
2006 and 2005, respectively.
Allowance for Slow-Moving Inventory
Inventories are stated at the lower of cost (average cost method) or market. See Item 8.
Financial Statements and Supplementary Data, Note D Inventories. We maintain an allowance for
slow-moving and obsolete inventory. For finished goods inventory, we estimate the amount of
inventory that may not be sold prior to its expiration or is slow moving based upon recent sales
activity by unit and wholesaler inventory information. We also analyzed our raw material and
component inventory for slow moving items. For the years ended December 31, 2006, 2005, and 2004,
we recorded a provision for inventory obsolescence of $652,000, $530,000 and $1,290,000,
respectively. The allowance for inventory obsolescence was $ 510,000 and $916,000 as of December
31, 2006 and 2005, respectively.
Warranty Liability
The DTPA product warranty relates to a ten year expiration guarantee on DTPA sold to HHS. We
are performing yearly stability studies for this product and, if the annual stability does not
support the ten-year product life, we will replace the product at no charge. Our supplier, Hameln
Pharmaceuticals, will also share this cost if we do not meet the DTPA stability requirement. If
the ongoing
30
product testing confirms the ten-year stability for DTPA we will not incur a replacement cost
and this reserve will be eliminated with a corresponding reduction to cost of sales after the
ten-year period.
Income Taxes
Deferred income tax assets and liabilities are determined based on differences between
financial reporting and tax bases of assets and liabilities, and net operating loss and other tax
credit carryforwards. These items are measured using the enacted tax rates and laws that will be in
effect when the differences are expected to reverse. We record a valuation allowance to reduce the
deferred income tax assets to the amount that is more likely than not to be realized.
Intangibles
Intangibles consist primarily of product licensing and other such costs that are capitalized
and amortized on the straight-line method over the lives of the related license periods or the
estimated life of the acquired product, which range from 3 years to 18 years. Accumulated
amortization at December 31, 2006 and 2005 was $16,260,000 and $14,875,000, respectively.
Amortization expense was $1,385,000, $1,508,000, and $1,372,000 for the years ended December 31,
2006, 2005, and 2004, respectively. We regularly assess the impairment of intangibles based on
several factors, including estimated fair market value and anticipated cash flows. In 2004, we
recorded impairment charges on certain intangible assets. See Item 8. Financial Statements and
Supplementary Data, Note S Asset Impairment Charges.
Stock-Based Compensation
Under SFAS No. 123(R), stock compensation cost is estimated at the grant date based on the
fair value of the award, and the cost is recognized as expense ratably over the vesting period. We
have historically used the Black-Scholes model for estimating the fair value of stock options in
providing the pro forma fair value method disclosures pursuant to SFAS No. 123 and have decided to
continue using this model under SFAS No. 123(R). Determining the assumptions that enter into the
model is highly subjective and requires judgment. We use an expected volatility that is based on
the historical volatility of our stock. The expected life assumption is based on historical
employee exercise patterns and employee post-vesting termination behavior. The risk-free interest
rate for the expected term of the option is based on the average market rate on U.S. treasury
securities in effect during the quarter in which the options were granted. The dividend yield
reflects historical experience as well as future expectations over the expected term of the option.
Also, under SFAS No. 123(R), we are required to estimate forfeitures at the time of grant and
revise in subsequent periods, if necessary, if actual forfeitures differ from those estimates.
After reviewing historical forfeiture information, we have decided to use 10% as an estimated
forfeiture rate.
RECENT ACCOUNTING PRONOUNCEMENTS
In February 2006, the Financial Accounting Standard Board (FASB) issued SFAS No. 155,
Accounting for Certain Hybrid Financial Instruments An Amendment of FASB Statements No. 133 and
140. This statement amends SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities, and No. 140, Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities. SFAS No. 155 permits fair value remeasurement for any hybrid
financial instrument that contains an embedded derivative that otherwise would require bifurcation.
This statement also establishes a requirement to evaluate interests in securitized financial assets
to identify interests that are freestanding derivatives or that are hybrid financial instruments
that contain an embedded derivative requiring bifurcation. SFAS No. 155 is effective for all
financial instruments acquired, issued, or subject to a remeasurement event occurring in fiscal
years beginning after December 15, 2006. We do not expect that the adoption of SFAS No. 155 will
have a significant impact on our consolidated financial statements.
In September 2005, the EITF reached a consensus on Issue No. 05-8, Income Tax Consequences of
Issuing Convertible Debt with a Beneficial Conversion Feature. Under EITF 05-8, the issuance of
convertible debt with a beneficial conversion feature results in a temporary difference for
purposes of applying Statement 109. The deferred taxes recognized for the temporary difference
should be recorded as an adjustment to paid-in capital. EITF 98-5 Accounting for Convertible
Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios and
EITF 00-27 Application of Issue No. 98-5 to Certain Convertible Instruments require that the
non-detachable conversion feature of a convertible debt security be accounted for separately if it
is a beneficial conversion feature. A beneficial conversion feature is recognized and measured by
allocating to additional paid-in capital a portion of the proceeds equal to the conversion
features intrinsic value. A discount on the convertible debt is recognized for the amount that is
allocated to additional paid-in capital. The debt discount is accreted from the date of issuance to
the stated redemption date of the convertible instrument or through the earliest conversion date if
the instrument does not have a stated redemption date. The
31
U.S. Federal Income Tax Code includes the entire amount of proceeds received at issuance as the tax
basis of the convertible debt security. The EITF 05-8 Consensus should be applied retrospectively
to all instruments with a beneficial conversion feature accounted for under EITF 98-5 and EITF
00-27 for periods beginning after December 15, 2005. The adoption of EITF 05-8 did not had have a
material impact on our financial statements.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections (SFAS
154), which replaces APB Opinion No. 20, Accounting Changes and SFAS No. 3, Reporting Accounting
Changes in Interim Financial Statements. SFAS 154 retained accounting guidance related to changes
in estimates, changes in a reporting entity and error corrections. However, changes in accounting
principles must be accounted for retrospectively by modifying the financial statements of prior
periods unless it is impracticable to do so. SFAS 154 is effective for accounting changes made in
fiscal years beginning after December 15, 2005. The adoption of SFAS 154 did not have a material
impact on our financial position, results of operations or cash flows.
In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No.
123R), which revised and replaced SFAS No. 123, Accounting for Stock-Based Payments and superseded
APB Opinion No. 25, Accounting for Stock Issued to Employees (APB 25). SFAS 123R requires the
measurement of all share-based payments to employees, including grants of employee stock options,
using a fair-value based method and the recording of such expense in its consolidated statements of
operations. The pro forma disclosures previously permitted under SFAS No. 123 are no longer an
alternative to financial statement recognition. The provisions for SFAS No. 123R are effective for
the first interim or annual reporting period beginning after June 15, 2005. We adopted SFAS No.
123R on January 1, 2006.
SFAS 123R permits public companies to adopt its requirements using one of two methods. The
first adoption method is a modified prospective method in which compensation cost is recognized
beginning with the effective date (i) based on the requirements of SFAS 123R for all share-based
payments granted after the effective date and (ii) based on the requirements of SFAS 123 for all
awards granted to employees prior to the effective date of SFAS 123R that remain unvested on the
effective date. The second adoption method is a modified retrospective method, which includes the
requirements of the modified prospective method described above, but also permits entities to
restate, based on the amounts previously recognized under SFAS 123 for purposes of pro forma
disclosures, either (i) all prior periods presented or (ii) prior interim periods in the year of
adoption.
We elected the modified prospective method and did not restate prior year amounts. The
adoption of SFAS 123Rs fair value method did have a significant impact on our results of
operations, although it had no impact on our overall financial position. Had we adopted SFAS 123R
in prior years, the impact of that adoption would have approximated the impact of SFAS 123, as
described in the disclosure of pro forma net earnings and pro forma earnings per share.
In November 2005, the FASB issued FASB Staff Position (FSP) No. 123(R)-3, Transition Election
Related to Accounting for Tax Effects of Share-Based Payment Awards (FSP 123(R)-3). We elected to
adopt the alternative transition method provided in FSP 123(R)-3 for calculating the tax effects of
stock-based compensation pursuant to SFAS 123-(R).
In June 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the
accounting for uncertainty in income taxes by prescribing a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. The interpretation also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, and disclosure. FIN 48 is
effective January 1, 2007. We are in the process of evaluating the impact that FIN 48 will have on
our Consolidated Financial Statements. At this time we do not believe that adoption of FIN 48 will
have a material impact on our financial position, results of operations or cash flows.
In September 2006 the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157), which
provides guidance on how to measure assets and liabilities that use fair value. SFAS 157 will
apply whenever another U.S. GAAP standard requires (or permits) assets or liabilities to be
measured at fair value but does not expand the use of fair value to any new circumstances. This
standard will also require additional disclosures in both annual and quarterly reports. SFAS 157
will be effective for financial statements issued for fiscal years beginning after November 15,
2007. The adoption of SFAS 157 is not expected to have a material impact on our results of
operations or financial position.
In September 2006, the SEC issued SAB No. 108, Considering the Effects of Prior Year
Misstatements when Quantifying Misstatements in Current Year Financial Statements. This Bulletin
addresses quantifying the financial statement effects of misstatements, including how the effects
of prior year uncorrected errors must be considered in quantifying misstatements in the current
year financial statements. This Bulletin is effective for fiscal years ending after November 15,
2006 and allows for a one-time
32
transitional cumulative effect adjustment to beginning retained earnings in the fiscal year adopted
for errors that were not previously deemed material, but are material under the guidance in SAB No.
108. The adoption of this Bulletin is not expected to have a material impact on our financial
statements.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
We are subject to market risk associated with changes in interest rates if we draw a balance
under our Credit Facility. Our only current interest rate exposure involves our Revolver debt under
the Credit Facility which bears interest at prime (8.25% as of December 31, 2006) plus 0.50%. The
balance on the Revolver at December 31, 2006 was zero. With the retirement of the Tranche A and
Tranche B notes and also the 2003 Subordinated Notes in March 2006 our interest rate exposure was
substantially diminished compared to our exposure for these prime-rate based instruments in 2005.
Our other long-term debt is for our mortgaged property in Decatur, Illinois at a fixed interest
rate of 7.375%. We estimate that a change of 1.0% in our variable rate debt from the interest rates
in effect at December 31, 2006 would result in a zero pre-tax change in annual interest expense
based on our existing zero drawdown against our revolving line of credit.
Our financial instruments consist mainly of cash, accounts receivable, accounts payable and
debt. The carrying amounts of these instruments, except debt, approximate fair value due to their
short-term nature. The carrying amounts of our bank borrowings under our debt instruments
approximate fair value because the interest rates are reset periodically to reflect current market
rates.
The fair value of the debt obligations approximated the recorded value as of December 31,
2006.
Item 8. Financial Statements and Supplementary Data
The following financial statements are included in Part II, Item 8 of this Form 10-K.
INDEX:
33
Report of Independent Registered Public Accounting Firm
Board of Directors and Shareholders
Akorn, Inc.
Buffalo Grove, Illinois
We have audited the accompanying consolidated balance sheets of Akorn, Inc. and Subsidiaries as of
December 31, 2006 and 2005 and the related consolidated statements of operations, shareholders
equity, and cash flows for each of the three years in the period ended December 31, 2006. These
financial statements are the responsibility of the Companys management. Our responsibility is to
express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements, assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the financial statements. We believe
that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Akorn, Inc. and Subsidiaries at December 31, 2006 and
2005 and the results of their operations and cash flows for each of the three years in the period
ended December 31, 2006, in conformity with accounting principles generally accepted in the United
States of America.
As disclosed in Note J to the consolidated financial statements, effective January 1, 2006, the
Company adopted the fair value method of accounting provisions of Statement of Financial Accounting
Standard No. 123 (revised 2004), Share Based Payment.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the effectiveness of Akorn, Inc. and Subsidiaries internal control over
financial reporting as of December 31, 2006, based on criteria established in Internal Control
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission
(COSO) and our report dated March 7, 2007 expressed an unqualified opinion thereon.
/s/ BDO Seidman, LLP
Chicago, Illinois
March 7, 2007
34
Report of Independent Registered Public Accounting Firm on
Internal Control over Financial Reporting
Board of Directors
Akorn, Inc.
Buffalo Grove, Illinois
We have audited managements assessment, included in the accompanying Item 9A, Managements Report
on Internal Control Over Financial Reporting, that Akorn, Inc. and Subsidiaries maintained
effective internal control over financial reporting as of December 31, 2006, based on criteria
established in Internal Control-Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (the COSO criteria). The Companys management is
responsible for maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting. Our responsibility is
to express an opinion on managements assessment and an opinion on the effectiveness of the
Companys internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, evaluating managements assessment, testing and evaluating the
design and operating effectiveness of internal control, and performing such other procedures as we
considered necessary in the circumstances. We believe that our audit provides a reasonable basis
for our opinion.
A companys internal control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles. A
companys internal control over financial reporting includes those policies and procedures that (1)
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of management and directors of the company;
and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or
detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that the Company maintained effective internal control over
financial reporting as of December 31, 2006, is fairly stated, in all material respects, based on
the COSO criteria. Also in our opinion, the Company maintained, in all material respects, effective
internal control over financial reporting as of December 31, 2006, based on the COSO criteria.
We have also audited, in accordance with the standards of the Public Company Accounting Standards
Board (United States), the consolidated balance sheets of Akorn, Inc. and Subsidiaries as of
December 31, 2006 and 2005, and the related consolidated statements of operations, shareholders
equity and cash flows for each of the three years in the period ended December 31, 2006 and our
report dated March 7, 2007 expressed an unqualified opinion on those consolidated financial
statements.
/s/ BDO Seidman, LLP
Chicago, Illinois
March 7, 2007
35
AKORN, INC.
CONSOLIDATED BALANCE SHEETS
(Dollars in Thousands, Except Share Data)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
ASSETS |
|
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
21,818 |
|
|
$ |
791 |
|
Trade accounts receivable (less allowance for doubtful accounts of $3 and $13 at
December 31, 2006 and 2005, respectively) |
|
|
4,781 |
|
|
|
3,222 |
|
Inventories |
|
|
11,734 |
|
|
|
10,279 |
|
Prepaid expenses and other current assets |
|
|
1,321 |
|
|
|
1,402 |
|
|
|
|
|
|
|
|
TOTAL CURRENT ASSETS |
|
|
39,654 |
|
|
|
15,694 |
|
PROPERTY, PLANT AND EQUIPMENT, NET |
|
|
33,486 |
|
|
|
31,071 |
|
OTHER ASSETS |
|
|
|
|
|
|
|
|
Intangibles, net |
|
|
8,825 |
|
|
|
10,210 |
|
Other |
|
|
118 |
|
|
|
120 |
|
|
|
|
|
|
|
|
TOTAL OTHER ASSETS |
|
|
8,943 |
|
|
|
10,330 |
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
82,083 |
|
|
$ |
57,095 |
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Current installments of debt |
|
$ |
394 |
|
|
$ |
7,044 |
|
Trade accounts payable |
|
|
4,719 |
|
|
|
3,046 |
|
Accrued compensation |
|
|
1,849 |
|
|
|
1,519 |
|
Accrued expenses and other liabilities |
|
|
3,291 |
|
|
|
3,851 |
|
|
|
|
|
|
|
|
TOTAL CURRENT LIABILITIES |
|
|
10,253 |
|
|
|
15,460 |
|
Long-term debt, less current installments |
|
|
208 |
|
|
|
602 |
|
Warranty liability |
|
|
1,308 |
|
|
|
¯ |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES |
|
|
11,769 |
|
|
|
16,062 |
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
|
|
|
|
|
SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Common stock, no par value 150,000,000 shares authorized; 85,990,964, and
27,618,745 shares issued and outstanding at December 31, 2006 and 2005, respectively |
|
|
150,250 |
|
|
|
67,339 |
|
Series A Preferred Stock, $1.00 par value 257,172 shares authorized and issued,
241,122 shares outstanding as of December 31, 2005 |
|
|
|
|
|
|
27,232 |
|
Series B Preferred Stock, $1.00 par value 170,000 shares authorized, 141,000 shares
issued, 106,600 outstanding as of December 31, 2005 |
|
|
|
|
|
|
10,758 |
|
Warrants to acquire common stock |
|
|
4,862 |
|
|
|
13,696 |
|
Accumulated deficit |
|
|
(84,798 |
) |
|
|
(77,992 |
) |
|
|
|
|
|
|
|
TOTAL SHAREHOLDERS EQUITY |
|
|
70,314 |
|
|
|
41,033 |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
|
$ |
82,083 |
|
|
$ |
57,095 |
|
|
|
|
|
|
|
|
See notes to the consolidated financial statements.
36
AKORN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Revenues |
|
$ |
71,250 |
|
|
$ |
44,484 |
|
|
$ |
50,708 |
|
Cost of sales |
|
|
44,370 |
|
|
|
29,540 |
|
|
|
32,506 |
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
|
|
26,880 |
|
|
|
14,944 |
|
|
|
18,202 |
|
Selling, general and administrative expenses |
|
|
18,603 |
|
|
|
16,405 |
|
|
|
13,300 |
|
Amortization and write down of intangibles |
|
|
1,385 |
|
|
|
1,508 |
|
|
|
3,409 |
|
Research and development expenses |
|
|
11,797 |
|
|
|
4,510 |
|
|
|
1,861 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
31,785 |
|
|
|
22,423 |
|
|
|
18,570 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING LOSS |
|
|
(4,905 |
) |
|
|
(7,479 |
) |
|
|
(368 |
) |
Interest expense |
|
|
(604 |
) |
|
|
(2,325 |
) |
|
|
(4,218 |
) |
Debt Retirement Gain/(Expense) |
|
|
(391 |
) |
|
|
1,212 |
|
|
|
|
|
Gain related to disputed settlements |
|
|
|
|
|
|
|
|
|
|
1,562 |
|
Other income/(expense) |
|
|
(60 |
) |
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE INCOME TAXES |
|
|
(5,960 |
) |
|
|
(8,592 |
) |
|
|
(3,018 |
) |
Income tax provision |
|
|
3 |
|
|
|
17 |
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
|
(5,963 |
) |
|
|
(8,609 |
) |
|
|
(3,026 |
) |
Preferred stock dividends and adjustments |
|
|
(843 |
) |
|
|
(4,082 |
) |
|
|
(34,436 |
) |
|
|
|
|
|
|
|
|
|
|
NET LOSS AVAILABLE TO COMMON STOCKHOLDERS |
|
$ |
(6,806 |
) |
|
$ |
(12,691 |
) |
|
$ |
(37,462 |
) |
|
|
|
|
|
|
|
|
|
|
NET LOSS PER SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
BASIC |
|
$ |
(0.09 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.80 |
) |
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
$ |
(0.09 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.80 |
) |
|
|
|
|
|
|
|
|
|
|
SHARES USED IN COMPUTING NET LOSS PER SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
BASIC |
|
|
73,988 |
|
|
|
26,095 |
|
|
|
20,817 |
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
73,988 |
|
|
|
26,095 |
|
|
|
20,817 |
|
|
|
|
|
|
|
|
|
|
|
See notes to the consolidated financial statements.
37
AKORN, INC.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2006, 2005 AND 2004
(In Thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants |
|
Retained |
|
|
|
|
Common Stock |
|
Series A |
|
Series B |
|
to acquire |
|
Earnings |
|
|
|
|
Addl Paid-In-Capital |
|
Preferred |
|
Preferred |
|
Common |
|
(Accum. |
|
|
|
|
Shares |
|
Amount |
|
Stock |
|
Stock |
|
Stock |
|
Deficit) |
|
Total |
|
|
|
BALANCES AT DECEMBER 31, 2003 |
|
|
19,826 |
|
|
$ |
25,506 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
13,724 |
|
|
$ |
(27,839 |
) |
|
$ |
11,391 |
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,026 |
) |
|
|
(3,026 |
) |
Reclassification of Series A Preferred Stock |
|
|
|
|
|
|
|
|
|
|
22,182 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,182 |
|
Issuance of Series B Preferred Stock and Warrants, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,914 |
|
|
|
3,130 |
|
|
|
|
|
|
|
13,044 |
|
Preferred stock dividends earned |
|
|
|
|
|
|
|
|
|
|
822 |
|
|
|
300 |
|
|
|
|
|
|
|
(1,122 |
) |
|
|
|
|
Intrinsic value of beneficial conversion features in convertible preferred stock |
|
|
|
|
|
|
25,826 |
|
|
|
(22,862 |
) |
|
|
(2,964 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Accretion to stated value of preferred stock |
|
|
|
|
|
|
|
|
|
|
27,232 |
|
|
|
6,094 |
|
|
|
|
|
|
|
(33,326 |
) |
|
|
|
|
Conversion of preferred stock into common stock |
|
|
2,236 |
|
|
|
1,822 |
|
|
|
(1,587 |
) |
|
|
(235 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants into common stock |
|
|
2,433 |
|
|
|
4,807 |
|
|
|
|
|
|
|
|
|
|
|
(2,771 |
) |
|
|
12 |
|
|
|
2,048 |
|
Intrinsic value of beneficial conversion features in convertible interest |
|
|
|
|
|
|
269 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
269 |
|
Adjustment of AEG warrant value due to dispute settlement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
77 |
|
|
|
|
|
|
|
77 |
|
Exercise of stock options |
|
|
594 |
|
|
|
1,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,233 |
|
Employee stock purchase plan issuances |
|
|
44 |
|
|
|
108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
108 |
|
|
|
|
BALANCES AT DECEMBER 31, 2004 |
|
|
25,133 |
|
|
|
59,571 |
|
|
|
25,787 |
|
|
|
13,109 |
|
|
|
14,160 |
|
|
|
(65,301 |
) |
|
|
47,326 |
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,609 |
) |
|
|
(8,609 |
) |
Preferred stock dividends earned |
|
|
|
|
|
|
|
|
|
|
1,563 |
|
|
|
783 |
|
|
|
|
|
|
|
(2,346 |
) |
|
|
|
|
Intrinsic value of beneficial conversion features in convertible preferred stock |
|
|
|
|
|
|
1,736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,736 |
) |
|
|
|
|
Conversion of preferred stock into common stock |
|
|
1,409 |
|
|
|
3,252 |
|
|
|
(118 |
) |
|
|
(3,134 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants into common stock |
|
|
350 |
|
|
|
652 |
|
|
|
|
|
|
|
|
|
|
|
(464 |
) |
|
|
|
|
|
|
188 |
|
Intrinsic value of beneficial conversion features in convertible interest |
|
|
|
|
|
|
353 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
353 |
|
Exercise of stock options |
|
|
693 |
|
|
|
1,287 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,287 |
|
Employee stock purchase plan issuances |
|
|
34 |
|
|
|
81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
81 |
|
Amortization of Deferred Compensation related to Restricted Stock Awards |
|
|
|
|
|
|
407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
407 |
|
|
|
|
BALANCES AT DECEMBER 31, 2005 |
|
|
27,619 |
|
|
|
67,339 |
|
|
|
27,232 |
|
|
|
10,758 |
|
|
|
13,696 |
|
|
|
(77,992 |
) |
|
|
41,033 |
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,963 |
) |
|
|
(5,963 |
) |
Preferred stock dividends earned |
|
|
|
|
|
|
|
|
|
|
55 |
|
|
|
536 |
|
|
|
|
|
|
|
(591 |
) |
|
|
|
|
Intrinsic value of beneficial conversion features in convertible preferred stock |
|
|
|
|
|
|
252 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(252 |
) |
|
|
|
|
Conversion of preferred stock into common stock |
|
|
41,275 |
|
|
|
38,581 |
|
|
|
(27,287 |
) |
|
|
(11,294 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants into common stock |
|
|
6,957 |
|
|
|
13,503 |
|
|
|
|
|
|
|
|
|
|
|
(10,655 |
) |
|
|
|
|
|
|
2,848 |
|
Conversion of convertible notes into common stock |
|
|
3,540 |
|
|
|
7,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,298 |
|
Net Proceeds from issuance of common stock and warrants |
|
|
5,312 |
|
|
|
19,800 |
|
|
|
|
|
|
|
|
|
|
|
1,821 |
|
|
|
|
|
|
|
21,621 |
|
Exercise of stock options |
|
|
1,107 |
|
|
|
1,672 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,672 |
|
Employee stock purchase plan issuances |
|
|
41 |
|
|
|
173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
173 |
|
Amortization of Deferred Compensation related to Restricted Stock Awards |
|
|
|
|
|
|
719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
719 |
|
Restricted Stock Awards withheld for payment of employee tax liability |
|
|
140 |
|
|
|
(316 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(316 |
) |
Accrue FAS123R Share Based Payment Expense |
|
|
|
|
|
|
1,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,229 |
|
|
|
|
BALANCES AT DECEMBER 31, 2006 |
|
|
85,991 |
|
|
$ |
150,250 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,862 |
|
|
$ |
(84,798 |
) |
|
$ |
70,314 |
|
|
|
|
See notes to the consolidated financial statements.
38
AKORN, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Dollars in Thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,963 |
) |
|
$ |
(8,609 |
) |
|
$ |
(3,026 |
) |
Adjustments to reconcile net loss to net cash from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
3,344 |
|
|
|
5,239 |
|
|
|
4,075 |
|
Amortization of deferred financing fees |
|
|
28 |
|
|
|
74 |
|
|
|
1,208 |
|
Amortization of debt discount |
|
|
1,059 |
|
|
|
1,237 |
|
|
|
945 |
|
Impairment of long-lived assets |
|
|
|
|
|
|
|
|
|
|
2,037 |
|
Non-cash expense related to preferred stock |
|
|
|
|
|
|
|
|
|
|
1,064 |
|
Prepayments to Strides Arcolab Limited |
|
|
|
|
|
|
(250 |
) |
|
|
|
|
Gain on retirement of debt |
|
|
|
|
|
|
(1,212 |
) |
|
|
|
|
Non-cash stock compensation expense |
|
|
1,948 |
|
|
|
407 |
|
|
|
|
|
Gain related to dispute settlements |
|
|
|
|
|
|
|
|
|
|
(1,562 |
) |
Gain on disposal of long-lived assets |
|
|
|
|
|
|
|
|
|
|
(6 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Trade accounts receivable |
|
|
(1,559 |
) |
|
|
3,360 |
|
|
|
(4,956 |
) |
Inventories |
|
|
(1,455 |
) |
|
|
142 |
|
|
|
(2,614 |
) |
Prepaid expenses and other current assets |
|
|
81 |
|
|
|
(198 |
) |
|
|
(1,234 |
) |
Trade accounts payable |
|
|
1,673 ( |
|
|
|
2,351 |
) |
|
|
(14 |
) |
Product Warranty |
|
|
1,308 |
|
|
|
|
|
|
|
|
|
Royalty Liability |
|
|
1,517 |
|
|
|
|
|
|
|
|
|
Accrued customer liability |
|
|
256 - |
|
|
|
|
|
|
|
|
|
Accrued expenses and other liabilities |
|
|
272 |
|
|
|
2,013 |
|
|
|
622 |
|
|
|
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES |
|
|
2,509 |
|
|
|
(148 |
) |
|
|
(3,461 |
) |
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment |
|
|
(4,377 |
) |
|
|
(1,782 |
) |
|
|
(689 |
) |
Proceeds from sale of investments |
|
|
|
|
|
|
|
|
|
|
2,000 |
|
Proceeds from sale of long-lived assets |
|
|
|
|
|
|
|
|
|
|
6 |
|
Purchase of product intangibles and product licenses |
|
|
|
|
|
|
(75 |
) |
|
|
(2,155 |
) |
|
|
|
|
|
|
|
|
|
|
NET CASH USED IN INVESTING ACTIVITIES |
|
|
(4,377 |
) |
|
|
(1,857 |
) |
|
|
(838 |
) |
FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Repayments of long-term debt |
|
|
(3,103 |
) |
|
|
(370 |
) |
|
|
(6,730 |
) |
Repayment of NeoPharm Debt |
|
|
|
|
|
|
(2,500 |
) |
|
|
|
|
Net proceeds from common stock and warrant offering |
|
|
21,621 |
|
|
|
|
|
|
|
13,044 |
|
Change in line of credit |
|
|
|
|
|
|
|
|
|
|
(1,500 |
) |
Proceeds from exercise of stock warrants |
|
|
2,848 |
|
|
|
188 |
|
|
|
2,036 |
|
Proceeds under stock option and stock purchase plans |
|
|
1,529 |
|
|
|
1,368 |
|
|
|
1,341 |
|
|
|
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES |
|
|
22,895 |
|
|
|
(1,314 |
) |
|
|
8,191 |
|
|
|
|
|
|
|
|
|
|
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
21,027 |
|
|
|
(3,319 |
) |
|
|
3,892 |
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR |
|
|
791 |
|
|
|
4,110 |
|
|
|
218 |
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT END OF YEAR |
|
$ |
21,818 |
|
|
$ |
791 |
|
|
$ |
4,110 |
|
|
|
|
|
|
|
|
|
|
|
See notes to the consolidated financial statements.
39
AKORN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note A Business and Basis of Presentation
Business: Akorn, Inc. and its wholly owned subsidiary, Akorn (New Jersey), Inc. (collectively,
the Company) manufacture and market diagnostic and therapeutic pharmaceuticals in specialty areas
such as ophthalmology, rheumatology, anesthesia and antidotes, among others. Customers, including
physicians, optometrists, wholesalers, group purchasing organizations and other pharmaceutical
companies, are served primarily from three operating facilities in the United States. In September
2004, the Company, along with a venture partner, formed a mutually owned limited liability company,
Akorn-Strides, LLC (the Joint Venture Company). See Note Q Business Alliances.
Basis of Presentation: The accompanying financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and the satisfaction of liabilities in
the normal course of business. As a result of the debt refinancing and equity transactions
disclosed in Notes G and H, the Company has substantially reversed its historical liquidity
concerns. The Company believes that its current line of credit, together with cash generated from
operations, will be sufficient to meet its near-term cash requirements.
Note B Summary of Significant Accounting Policies
Consolidation: The accompanying consolidated financial statements include the accounts of
Akorn, Inc and its wholly owned subsidiary, Akorn (New Jersey) Inc. Intercompany transactions and
balances have been eliminated in consolidation.
Use of Estimates: The preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting period. Actual results could differ materially from
those estimates. Significant estimates and assumptions for the Company relate to the allowance for
doubtful accounts, the allowance for chargebacks, the allowance for rebates, the allowance for
product returns and discounts and the reserve for slow-moving and obsolete inventories, the
carrying value of intangible assets and the carrying value of deferred income tax assets.
Revenue Recognition: The Company recognizes product sales for its ophthalmic and hospital
drugs and injectables business segments upon the shipment of goods or upon the delivery of the
product or service as appropriate. Revenue is recognized when all obligations of the Company have
been fulfilled and collection of the related receivable is probable.
The contract services segment, which produces products for third party customers based upon
their specification and at a pre-determined price, also recognizes sales upon the shipment of goods
or upon delivery of the product or service as appropriate. Revenue is recognized when all
obligations of the Company have been fulfilled and collection of the related receivable is
probable.
Provision for estimated doubtful accounts, chargebacks, rebates, discounts and product returns
is made at the time of sale and is analyzed and adjusted, if necessary, at each balance sheet date.
Cash Equivalents: The Company considers all highly liquid investments with maturity of three
months or less when purchased, to be cash equivalents.
Accounts Receivable: The nature of the Companys business inherently involves, in the ordinary
course, significant amounts and substantial volumes of transactions and estimates relating to
allowances for doubtful accounts, product returns, chargebacks, rebates and discounts given to
customers. This is a natural circumstance of the pharmaceutical industry and not specific to the
Company and inherently lengthens the collection process. Depending on the product, the end-user
customer, the specific terms of national supply contracts and the particular arrangements with the
Companys wholesaler customers, certain rebates, chargebacks and other credits are deducted from
the Companys accounts receivable. The process of claiming these deductions depends on wholesalers
reporting to the Company the amount of deductions that were earned under the respective terms with
end-user customers (which, in turn, depends on which end-user customer with different pricing
arrangements might be entitled to a particular deduction). This process can lead to partial
payments against outstanding invoices as the wholesalers take the claimed deductions at the time
of payment.
40
Unless otherwise noted, the provisions and allowances for the following customer deductions
are reflected in the accompanying financial statements as reductions of revenues and trade accounts
receivable, respectively.
Chargebacks and Rebates: The Company enters into contractual agreements with certain third parties
such as hospitals and group-purchasing organizations to sell certain products at predetermined
prices. The parties have elected to have these contracts administered through wholesalers that buy
the product from the Company and subsequently sell it to these third parties. When a wholesaler
sells products to one of these third parties that are subject to a contractual price agreement, the
difference between the price paid to the Company by the wholesaler and the price under the specific
contract is charged back to the Company by the wholesaler. The Company tracks sales and submitted
chargebacks by product number and contract for each wholesaler. Utilizing this information, the
Company estimates a chargeback percentage for each product. The Company reduces gross sales and
increases the chargeback allowance by the estimated chargeback amount for each product sold to a
wholesaler. The Company reduces the chargeback allowance when it processes a request for a
chargeback from a wholesaler. Actual chargebacks processed by the Company can vary materially from
period to period based upon actual sales volume through the wholesalers. However, the Companys
provision for chargebacks is fully reserved for at the time when sales revenues are recognized.
Management obtains certain wholesaler inventory reports to aid in analyzing the reasonableness
of the chargeback allowance. The Company assesses the reasonableness of its chargeback allowance by
applying the product chargeback percentage based on historical activity to the quantities of
inventory on hand per the wholesaler inventory reports and an estimate of in-transit inventory that
is not reported on the wholesaler inventory reports at the end of the period. In accordance with
its accounting policy, the Companys estimate of the percentage amount of wholesaler inventory that
will ultimately be sold to a third party that is subject to a contractual price agreement is based
on a six-quarter trend of such sales through wholesalers. The Company uses this percentage estimate
(95% as of December 31, 2006) until historical trends indicate that a revision should be made. On
an ongoing basis, the Company evaluates its actual chargeback rate experience and new trends are
factored into its estimates each quarter as market conditions change. In the first quarter of 2004,
the Company obtained more precise information from the wholesalers to estimate the amount of
in-transit inventory, which lowered its estimate of in-transit inventory. This resulted in the
Company recognizing approximately $500,000 less in chargeback expense in the first quarter of 2004.
The Company is using this new information on a going forward basis as a more accurate
estimate of in-transit inventory. Additionally, in the second quarter of 2004, the Company, in
accordance with its policy, reduced its estimate of the percentage amount of wholesaler inventory
that will ultimately be sold to a third party that is subject to a contractual price agreement.
This reduction was made in reaction to a six-quarter trend of such sales being below the Companys
previous estimates, thereby confirming that the reduced percentage was other than temporary. This
estimate change resulted in approximately $480,000 less in chargeback expense in the second quarter
of 2004. In the fourth quarter of 2005, Management reviewed sales trends through wholesalers and
revised the estimated percentage amount of wholesaler inventory that will ultimately be sold to a
third party that is subject to a contractual price agreement which resulted in a $408,000 increase
in chargeback expense in the fourth quarter 2005. The Company again reviewed and revised this same
percentage estimate in the fourth quarter of 2006 which resulted in a $446,000 increase in the
chargeback expense in the fourth quarter of 2006. The Company intends to use this revised estimate
on a going forward basis until historical trends indicate that additional revisions should be made.
Similarly, the Company maintains an allowance for rebates related to contract and other
programs with certain customers. Rebate percentages vary by product and by volume purchased by each
eligible customer. The Company tracks sales by product number for each eligible customer and then
applies the applicable rebate percentage, using both historical trends and actual experience to
estimate its rebate allowance. The Company reduces gross sales and increases the rebate allowance
by the estimated rebate amount when the Company sells its products to its rebate-eligible
customers. The Company reduces the rebate allowance when it processes a customer request for a
rebate. At each balance sheet date, the Company analyzes the allowance for rebates against actual
rebates processed and makes necessary adjustments as appropriate. Actual rebates processed can vary
materially from period to period. However, the Companys provision for rebates is fully reserved
for at the time when sales revenues are recognized.
The recorded allowances reflect the Companys current estimate of the future chargeback and
rebate liability to be paid or credited to its wholesaler and other customers under the various
contracts and programs. For the years ended December 31, 2006, 2005, and 2004, the Company recorded
chargeback and rebate expense of $26,295,000, $24,391,000 and $16,915,000, respectively. The
allowance for chargebacks and rebates was $8,370,000 and $7,634,000 as of December 31, 2006 and
2005, respectively.
Sales Returns: Certain of the Companys products are sold with the customer having the right
to return the product within specified periods and guidelines for a variety of reasons, including
but not limited to, pending expiration dates. Provisions are made at the time of sale based upon
tracked historical experience, by customer in some cases. The Company estimates its sales returns
reserve based on a historical percentage of returns to sales utilizing a twelve month look back
period. One-time historical factors or pending
41
new developments that would impact the expected level of returns are taken into account to
determine the appropriate reserve estimate at each balance sheet date.. As part of the evaluation
of the balance required, the Company considers actual returns to date that are in process, the
expected impact of any product recalls and the wholesalers inventory information to assess the
magnitude of unconsumed product that may result in a sales return to the Company in the future. The
sales returns level can be impacted by factors such as overall market demand and market competition
and availability for substitute products which can increase or decrease the end-user pull through
for sales of the Companys products and ultimately impact the level of sales returns. Actual
returns experience and trends are factored into the Companys estimates each quarter as market
conditions change. Actual returns processed can vary materially from period to period. For the
years ended December 31, 2006, 2005, and 2004 the Company recorded a provision for product returns
of $3,861,000, $3,122,000 and $1,956,000, respectively. The allowance for potential product returns
was $2,437,000 and $1,529,000 at December 31, 2006 and 2005, respectively.
Doubtful Accounts: Provisions for doubtful accounts, which reflects trade receivable balances
owed to the Company that are believed to be uncollectible, are recorded as a component of selling,
general and administrative expenses. In estimating the allowance for doubtful accounts, the Company
has:
|
|
|
Identified the relevant factors that might affect the accounting estimate for allowance
for doubtful accounts, including: (a) historical experience with collections and write-offs;
(b) credit quality of customers; (c) the interaction of credits being taken for discounts,
rebates, allowances and other adjustments; (d) balances of outstanding receivables, and
partially paid receivables; and (e) economic and other exogenous factors that might affect
collectibility (e.g., bankruptcies of customers, channel factors, etc.). |
|
|
|
|
Accumulated data on which to base the estimate for allowance for doubtful accounts,
including: (a) collections and write-offs data; (b) information regarding current credit
quality of customers; and (c) information regarding exogenous factors, particularly in
respect of major customers. |
|
|
|
|
Developed assumptions reflecting managements judgments as to the most likely
circumstances and outcomes, regarding, among other matters: (a) collectibility of
outstanding balances relating to partial payments; (b) the ability to collect items in
dispute (or subject to reconciliation) with customers; and (c) economic and other exogenous
factors that might affect collectibility of outstanding balances based upon information
available at the time. |
For the years ended December 31, 2006, 2005, and 2004, the Company recorded a net
expense/(benefit) for doubtful accounts of ($150,000), $74,000, and ($43,000), respectively. The
2005 expense was mainly due to one uncollectible account while the favorable experience in 2006 and
2004 was due to recoveries and reduced reserve requirements which exceeded write offs and reduced
previously identified collectibility concerns. The allowance for doubtful accounts was $3,000 and
$13,000, as of December 31, 2006 and 2005, respectively. As of December 31, 2006, the Company had a
total of $196,000 of past due gross accounts receivable, of which $54,000 was over 60 days past
due. The Company performs monthly a detailed analysis of the receivables due from its wholesaler
customers and provides a specific reserve against known uncollectible items for each of the
wholesaler customers. The Company also includes in the allowance for doubtful accounts an amount
that it estimates to be uncollectible for all other customers based on a percentage of the past due
receivables. The percentage reserved increases as the age of the receivables increases.
Discounts: Cash discounts are available to certain customers based on agreed upon terms of
sale. The Company evaluates the discount reserve balance against actual discounts taken. For the
years ended December 31, 2006, 2005, and 2004, the Company recorded a provision for discounts of
$1,595,000, $1,003,000 and $925,000, respectively. The allowance for discounts was $236,000 and
$244,000 as of December 31, 2006 and 2005, respectively.
Inventories: Inventories are stated at the lower of cost (average cost method) or market (see
Note D Inventories). The Company maintains an allowance for slow-moving and obsolete inventory.
For finished goods inventory, the Company estimates the amount of inventory that may not be sold
prior to its expiration or is slow moving based upon recent sales activity by unit and wholesaler
inventory information. The Company also analyzes its raw material and component inventory for slow
moving items. For the years ended December 31, 2006, 2005, and 2004, the Company recorded a
provision for inventory obsolescence of $652,000, $530,000 and $1,290,000, respectively. The
allowance for inventory obsolescence was $510,000 and $916,000 as of December 31, 2006 and 2005,
respectively.
Intangibles: Intangibles consist primarily of product licensing and other such costs that are
capitalized and amortized on the straight-line method over the lives of the related license periods
or the estimated life of the acquired product, which range from 3 years to 18 years. Accumulated
amortization at December 31, 2006 and 2005 was $16,260,000 and $14,875,000, respectively.
Amortization
42
expense was $1,385,000, $1,508,000 and $1,372,000 for the years ended December 31, 2006, 2005, and
2004, respectively. The Company regularly assesses the impairment of intangibles based on several
factors, including estimated fair market value and anticipated cash flows.
During 2004, the Company recorded impairment charges of $2,037,000 related to product license
intangible assets for Biolon, Erythromycin, Cromolyn Sodium, AKWA Tears, and Tears Renewed in its
ophthalmic segment. The Company determined that projected profitability on the products was not
sufficient to support the carrying value of the intangible assets. The recording of these charges
reduced the carrying value of the intangible assets related to these product licenses to zero.
The amortization expense of acquired intangible assets, absent any further impairments, for
each of the five years ending December 31, 2011 will be as follows (in thousands):
|
|
|
|
|
For the year ended 12/31/07 |
|
$ |
1,355 |
|
For the year ended 12/31/08 |
|
$ |
1,354 |
|
For the year ended 12/31/09 |
|
$ |
1,354 |
|
For the year ended 12/31/10 |
|
$ |
1,354 |
|
For the year ended 12/31/11 |
|
$ |
1,313 |
|
Property, Plant and Equipment: Property, plant and equipment is stated at cost, less
accumulated depreciation. Depreciation is provided using the straight-line method in amounts
considered sufficient to amortize the cost of the assets to operations over their estimated service
lives or lease terms. The average estimated service lives of buildings, leasehold improvements,
furniture and equipment, and automobiles are approximately 30, 10, 10, and 5 years, respectively.
Depreciation expense was $1,959,000, $2,604,000 and $2,703,000 for 2006, 2005, and 2004,
respectively.
Net Loss Per Common Share: Basic net loss per common share is based upon weighted average
common shares outstanding. Diluted net loss per common share is based upon the weighted average
number of common shares outstanding, including the dilutive effect, if any, of stock options,
warrants and convertible securities using the treasury stock and if converted methods. However, due
to net losses in each of the last three years, the Company had no dilutive stock options, warrants
or convertible securities. Antidilutive shares excluded from the computation of diluted net loss
per share include 5,316,000, 59,661,000, and 59,229,000, for 2006, 2005, and 2004, respectively,
related to options, warrants and convertible securities.
Income Taxes: Deferred income tax assets and liabilities are determined based on differences
between financial reporting and tax bases of assets and liabilities, and net operating loss and
other tax credit carryforwards. These items are measured using the enacted tax rates and laws that
will be in effect when the differences are expected to reverse. The Company records a valuation
allowance to reduce the deferred income tax assets to the amount that is more likely than not to be
realized.
Fair Value of Financial Instruments: The Companys financial instruments include cash and cash
equivalents, accounts receivable, accounts payable and term debt. The fair values of cash and cash
equivalents, accounts receivable and accounts payable approximate fair value because of the short
maturity of these instruments. The carrying amounts of the Companys bank and subordinated
borrowings approximate fair value because the interest rates are reset periodically to reflect
current market rates.
Stock-Based Compensation: Under SFAS No. 123(R), stock compensation cost is estimated at the
grant date based on the fair value of the award, and the cost is recognized as expense ratably over
the vesting period. We have historically used the Black-Scholes model for estimating the fair
value of stock options in providing the pro forma fair value method disclosures pursuant to SFAS
No. 123 and have decided to continue using this model under SFAS No. 123(R). Determining the
assumptions that enter into the model is highly subjective and requires judgment. We use an
expected volatility that is based on the historical volatility of our stock. The expected life
assumption is based on historical employee exercise patterns and employee post-vesting termination
behavior. The risk-free interest rate for the expected term of the option is based on the average
market rate on U.S. treasury securities in effect during the quarter in which the options were
granted. The dividend yield reflects historical experience as well as future expectations over the
expected term of the option. Also, under SFAS No. 123(R), we are required to estimate forfeitures
at the time of grant and revise in subsequent periods, if necessary, if actual forfeitures differ
from those estimates. After reviewing historical forfeiture information, we have decided to use
10% as an estimated forfeiture rate.
43
Note C Allowance for Customer Deductions
The activity in various allowance accounts is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Doubtful Accounts Years Ended |
|
|
Returns |
|
|
|
December 31, |
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Balance at beginning of year |
|
$ |
13 |
|
|
$ |
435 |
|
|
$ |
609 |
|
|
$ |
1,529 |
|
|
$ |
1,393 |
|
|
$ |
1,077 |
|
Provision (recovery) |
|
|
(150 |
) |
|
|
74 |
|
|
|
(43 |
) |
|
|
3,861 |
|
|
|
3,122 |
|
|
|
1,956 |
|
Charges |
|
|
140 |
|
|
|
(496 |
) |
|
|
(131 |
) |
|
|
(2,953 |
) |
|
|
(2,986 |
) |
|
|
(1,640 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year |
|
$ |
3 |
|
|
$ |
13 |
|
|
$ |
435 |
|
|
$ |
2,437 |
|
|
$ |
1,529 |
|
|
$ |
1,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discounts |
|
|
Chargebacks and Rebates |
|
|
|
Years Ended December 31, |
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Balance at beginning of year |
|
$ |
244 |
|
|
$ |
234 |
|
|
$ |
94 |
|
|
$ |
7,634 |
|
|
$ |
5,406 |
|
|
$ |
4,804 |
|
Provision |
|
|
1,595 |
|
|
|
1,003 |
|
|
|
925 |
|
|
|
26,295 |
|
|
|
24,391 |
|
|
|
16,915 |
|
Charges |
|
|
(1,603 |
) |
|
|
(993 |
) |
|
|
(785 |
) |
|
|
(25,559 |
) |
|
|
(22,163 |
) |
|
|
(16,313 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of year |
|
$ |
236 |
|
|
$ |
244 |
|
|
$ |
234 |
|
|
$ |
8,370 |
|
|
$ |
7,634 |
|
|
$ |
5,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note D Inventories
The components of inventories are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Finished goods |
|
$ |
2,923 |
|
|
$ |
4,914 |
|
Work in process |
|
|
1,293 |
|
|
|
1,702 |
|
Raw materials and supplies |
|
|
7,518 |
|
|
|
3,663 |
|
|
|
|
|
|
|
|
|
|
$ |
11,734 |
|
|
$ |
10,279 |
|
|
|
|
|
|
|
|
The Company maintains an allowance for excess and obsolete inventory. The activity in this
account is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Balance at beginning of year |
|
$ |
916 |
|
|
$ |
660 |
|
|
$ |
917 |
|
Provision |
|
|
652 |
|
|
|
530 |
|
|
|
1,290 |
|
Charges |
|
|
(1,058 |
) |
|
|
(274 |
) |
|
|
(1,547 |
) |
|
|
|
|
|
|
|
|
|
|
Balance at end of year |
|
$ |
510 |
|
|
$ |
916 |
|
|
$ |
660 |
|
|
|
|
|
|
|
|
|
|
|
Note E Investment in Novadaq Technologies
In the first quarter of 2002, the Company received an equity ownership in Novadaq Technologies,
Inc., (Novadaq), of 4,000,000 common shares (representing approximately 16.4% of the outstanding
shares) as part of a settlement between the Company and Novadaq. The Company had previously
advanced $690,000 to Novadaq for development costs and recorded these advances as an intangible
asset. Based on the settlement, the Company had reclassified these advances as an Investment in
Novadaq. In the fourth quarter of 2002, the Company received an additional 132,000 shares of
Novadaq, valued at $23,000 which was recorded as a gain in 2002 pursuant to a pre-existing
agreement with another third party. In 2004, the Company and Novadaq reached an agreement on a
separate dispute whereby Novadaq repurchased the Companys holdings in Novadaq for $2,000,000. The
settlement resulted in a gain of $1,287,000 which is part of the $1,562,000 gain related to
disputed settlements in the 2004 Consolidated Statement of Operations. (See Note N Commitments
and Contingencies.)
Note F Property, Plant and Equipment
Property, plant and equipment consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Land |
|
$ |
396 |
|
|
$ |
396 |
|
Buildings and leasehold improvements |
|
|
18,071 |
|
|
|
9,393 |
|
Furniture and equipment |
|
|
37,826 |
|
|
|
27,866 |
|
Automobiles |
|
|
55 |
|
|
|
55 |
|
|
|
|
|
|
|
|
44
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
|
56,348 |
|
|
|
37,710 |
|
Accumulated depreciation |
|
|
(28,637) |
) |
|
|
(26,879 |
) |
|
|
|
|
|
|
|
|
|
|
27,711 |
|
|
|
10,831 |
|
Construction in progress |
|
|
5,775 |
|
|
|
20,240 |
|
|
|
|
|
|
|
|
|
|
$ |
33,486 |
|
|
$ |
31,071 |
|
|
|
|
|
|
|
|
Construction in progress represents capital expenditures principally related to the Companys
lyophilization facility. The accumulated lyophilization facility spending through December 31, 2006
was $22,433,000. The Company capitalized interest expense related to the lyophilization project of
$220,000 and $1,166,000 in 2004 and 2003, respectively. The Company estimates an additional
$200,000 in spending will be required to complete the expansion (excluding capitalized interest).
In December 2006, the Company placed $17,237,000 of this cost into service which is for the
facility and sterile solutions portion of this operation which augments its existing production
capacities. The remaining $5,196,000 of construction in progress, which is specific to
lyophilization (freeze-dry) operations, is awaiting final review and a Pre-Approval Inspection
(PAI) by the FDA for the Company to place this equipment into commercial production. The Company
anticipates a successful inspection and placing the lyophilization equipment in service in the
first half of 2007. There can be no assurance the Company will realize the anticipated benefits
from its investment into lyophilization capability and, if not, material impairment charges may be
required.
Note G Financing Arrangements
The Companys long-term debt consists of (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Convertible subordinated debentures |
|
$ |
|
|
|
$ |
5,000 |
|
Mortgage payable |
|
|
602 |
|
|
|
938 |
|
2003 Subordinated Notes |
|
|
|
|
|
|
2,767 |
|
|
|
|
|
|
|
|
|
|
|
602 |
|
|
|
8,705 |
|
Less unamortized discount on debt |
|
|
|
|
|
|
(1,059 |
) |
Less current installments |
|
|
(394 |
) |
|
|
(7,044 |
) |
|
|
|
|
|
|
|
Long-term debt |
|
$ |
208 |
|
|
$ |
602 |
|
|
|
|
|
|
|
|
Maturities of debt are as follows (in thousands):
|
|
|
|
|
Year ending December 31: |
|
|
|
|
|
|
|
|
|
2007 |
|
$ |
394 |
|
2008 |
|
|
208 |
|
|
|
|
|
Total |
|
$ |
602 |
|
|
|
|
|
In December 1997, the Company entered into a $45,000,000 (as amended) revolving credit
agreement with The Northern Trust Company (Northern Trust). Borrowings under this credit
agreement were secured by substantially all of the assets of the Company and bore floating interest
rates that were 7.25% at September 30, 2003. The Company went into default under the Northern Trust
credit agreement in 2002 and thereafter operated under an agreement under which Northern Trust
would agree to forbear from exercising its remedies (the Forbearance Agreement). The Forbearance
Agreement provided for additional borrowings and was extended on numerous occasions in 2003.
On October 7, 2003, a group of investors (the Investors) purchased all of the Companys then
outstanding senior bank debt from Northern Trust , a balance of $37,731,000, at a discount and
exchanged such debt with the Company (the Exchange Transaction) for (i) 257,172 shares of Series
A 6.0% Participating Convertible Preferred Stock (Series A Preferred Stock), (ii) subordinated
promissory notes in the aggregate principal amount of $2,767,139 (the 2003 Subordinated Notes),
(iii) warrants to purchase an aggregate of 8,572,400 shares of the Companys common stock with an
exercise price of $1.00 per share (Series A Warrants), and (iv) $5,473,862 in cash from the
proceeds of the term loan under the Credit Facility described in a following paragraph. The 2003
Subordinated Notes and cash were issued by the Company to (a) The John N. Kapoor Trust dated
9/20/89 (the Kapoor Trust), the sole trustee and sole beneficiary of which is Dr. John N. Kapoor,
the Companys Chairman of the Board of Directors and the holder of a significant stock position in
the Company, (b) Arjun Waney, a holder of a significant stock position in the Company, and (c)
Argent
45
Fund Management Ltd., for which Mr. Waney serves as Chairman and Managing Director and 52% of
which is owned by Mr. Waney. The Company also issued to the holders of the 2003 Subordinated Notes
warrants to purchase an aggregate of 276,714 shares of common stock with an exercise price of $1.10
per share.
As a result of the Exchange Transaction, the Company recorded transaction costs of
approximately $3,102,000. The transaction costs consisted principally of cash and securities owed
to restructuring and investment banking professionals that provided services directly related to
the extinguishment of the Northern Trust debt.
In accounting for the Exchange Transaction, the Company first reduced the carrying amount of
the Northern Trust debt by the cash paid to Investors. The remaining carrying value was then
allocated among the three securities issued to fully extinguish the debt based on the relative fair
values of those securities. Accordingly, the Series A Preferred Stock, the 2003 Subordinated Notes
and the Series A Warrants were initially recorded at $20,874,000, $2,046,000 and $9,337,000,
respectively, before, in the case of the 2003 Subordinated Notes, the discount described below and
before, in the case of the stock securities, related issuance costs of $480,000. The fair value of
the Series A Warrants was estimated by the Company using the same method and estimates as described
for the warrants issued with the 2003 Subordinated Notes. All outstanding warrants as described
above were exercised prior to their October 7, 2006 expiration date.
Simultaneously with the consummation of the Exchange Transaction, the Company entered into a
credit agreement with LaSalle Bank National Association (LaSalle Bank) providing the Company with
two Term Loans (collectively, the Term Loans) which consisted of a $5,500,000 term loan A, and a
$1,500,000 term loan B totaling $7,000,000, and a revolving line of credit of up to $5,000,000 (the
Revolver) to provide for working capital needs (collectively, the Credit Facility) secured by
substantially all of the assets of the Company. The obligations of the Company under the Credit
Facility had been guaranteed by the Kapoor Trust and Mr. Waney. In exchange for this guaranty, the
Company issued additional warrants (Guarantee Warrants) to purchase 880,000 and 80,000 shares of
common stock to the Kapoor Trust and Mr. Waney, respectively, and had agreed to issue to each of
them, on each anniversary of the date of the consummation of the Exchange Transaction, warrants to
purchase additional shares of common stock; however, the guarantees were terminated before the
first anniversary, as described below. The warrants issued in exchange for these guarantees had an
exercise price of $1.10 per share. These warrants were exercised in 2006 and none of the warrants
remain outstanding as of December 31, 2006.
The Term Loans bore interest at prime plus 1.75% and were paid in full on August 23, 2004.
The Credit Facility was set to mature on October 7, 2005 and was renewed on September 30, 2005. The
renewed Credit Facility expires in September 30, 2008 and does not provide for term loans, but
includes a revolving line of credit (the Revolver). The Revolver bears interest at prime plus
0.50% (8.25% as of December 31, 2006). Availability under the Revolver is determined by the sum of
(i) 80% of eligible accounts receivable, (ii) 50% of raw material, finished goods and component
inventory excluding packaging items, not to exceed $5,000,000 and (iii) the difference between 90%
of the forced liquidation value of machinery and equipment ($4,092,000 as of August 2003) and
$1,750,000. The availability as of December 31, 2006 was approximately $ 7,369,000. The Credit
Facility contains certain restrictive covenants including but not limited to certain financial
covenants such as EDITDA to interest expense and Senior Debt to EBITDA ratios. The Credit Facility
also contains subjective covenants providing that the Company would be in default if, in the
judgment of the lenders, there is a material adverse change in the Companys financial condition.
Because the Credit Facility also requires the Company to maintain its deposit accounts with LaSalle
Bank, the existence of these subjective covenants, pursuant to EITF Abstract No. 95-22, requires
that outstanding borrowings under the Revolver be classified as a current liability. On August 13,
2004, the Company entered into the First Amendment to the Credit Facility. Among other things, the
First Amendment amended certain financial covenants and LaSalle Bank agreed to waive certain events
of default arising out of noncompliance with certain obligations. Certain financial conditions in
the Kapoor Trust guaranty were also amended as a result of the First Amendment. On August 26, 2004,
the Company entered into the Second Amendment to the Credit Facility, which released the Kapoor
Trust guaranty and eliminated certain event of default provisions that were related to the Kapoor
Trust guaranty. In addition, on August 27, 2004, LaSalle Bank cancelled each of the irrevocable
standby letters of credit posted by Dr. Kapoor and Mr. Waney. On October 8, 2004, the Company
entered into the Third Amendment to the Credit Facility (the Third Amendment) which waived events
of default associated with the warrants issuance to AEG Partners, LLC (AEG) and the NeoPharm
Promissory Note default. In addition, the Third Amendment amended definitions of the Computation
Period and EBITDA to Interest Expense Ratio for covenant calculations.
As part of the Exchange Transaction, the Company recorded $1,627,000 as deferred financing
costs, including the value of the Guarantee Warrants. This amount was being amortized as a
component of interest expense over the life of the related debt or guarantee. With the retirement
of the Term Loans and related guarantee terminations in the third quarter of 2004, the remaining
guarantee warrant amortization and deferred financing costs not related to the Revolver were
charged to interest expense, resulting in
46
$245,000 of additional amortization. Including these adjustments, amortization in 2006, 2005
and 2004 was $0, $74,000, and $1,208,000, respectively.
As more fully described in Note H, the Company issued additional preferred stock and warrants
on August 23, 2004. A portion of the related proceeds was used to pay off the Term Loans and pay
down the Revolver. The Company continues to maintain the Revolver which, as of December 31, 2006,
had an outstanding balance of zero.
In 2001, the Company entered into a $5,000,000 convertible subordinated debt agreement (the
Convertible Note Agreement) consisting of a $3,000,000 Tranche A note (Tranche A Note) and a
$2,000,000 Tranche B note (Tranche B Note) with the Kapoor Trust. Borrowings under the Convertible
Note Agreement were due December 20, 2006, bore interest at prime plus 3.0% and were issued with
detachable warrants to purchase approximately 1,667,000 shares of common stock. Interest could not
be paid under the Convertible Note Agreement until the termination of the Credit Facility. The
convertible feature of the convertible subordinated debt, as amended, allowed the Kapoor Trust to
immediately convert the subordinated debt plus interest into common stock of the Company, at a
price of $2.28 per share of common stock for Tranche A Note and $1.80 per share of common stock for
Tranche B Note. The Company negotiated an early settlement of the Tranche A Note and the Tranche B
Note in March 2006. The associated principal and accumulated interest of approximately $7,298,000
was retired by conversion into 3,540,281 shares of the Companys common stock on March 31, 2006. A
debt retirement fee of approximately $391,000 was paid as an inducement to retire these notes prior
to the original maturity date of December 20, 2006. The detachable warrants to purchase 1,667,000
shares of common stock were exercised on a cashless basis on November 15, 2006 and the associated
net common stock issuance was 807,168 shares.
The Company, in accordance with APB Opinion No. 14, recorded the convertible subordinated debt
and related warrants as separate securities. Furthermore, in accordance with Emerging Issues Task
Force (EITF) Abstract No. 00-27, the Company had also computed and recorded a separate amount
related to the intrinsic value of the conversion option related to the debt. The resultant debt
discount of $3,024,000, equivalent to the value assigned to the warrants and the intrinsic value
of the conversion option, was amortized and charged to interest expense over the life of the
subordinated debt. Additionally, as the accrued interest on the convertible subordinated debt was
also convertible into common stock, it could also result in separately recordable beneficial
conversion amounts. Such amounts are recorded when the price of the Companys common stock is
higher than the conversion rate when the interest is accrued. The beneficial conversion feature
amount related to interest was $0, $353,000 and $269,000 in 2006, 2005 and 2004, respectively, and
was recorded as an increase to paid-in-capital and as additional debt discount amortizable over the
remaining term of the convertible subordinated debt. Related debt discount amortization was
$946,000, $728,000 and $573,000 in 2006, 2005, 2004, respectively.
In December 2001, the Company entered into a $3,250,000 five-year loan (the NeoPharm Note)
with NeoPharm, Inc. (NeoPharm) to fund the Companys efforts to complete its lyophilization
facility located in Decatur, Illinois. Dr. Kapoor, the Companys chairman, is also a director of
NeoPharm and holds a substantial stock position in NeoPharm, as well as in the Company .Under the
terms of the NeoPharm Note evidencing the loan, interest accrued at the initial rate of 3.6% to be
reset quarterly based upon NeoPharms average return on its cash and readily tradable long and
short-term securities during the previous calendar quarter. In consideration for the loan, under a
separate processing agreement between the Company and NeoPharm, the Company, agreed to provide
NeoPharm with access to at least 15% of the capacity of its lyophilization facility each year upon
completion of the lyophilization facility.
The NeoPharm Note was subordinate to the Companys senior debt owed to LaSalle Bank but was
senior to the subordinated debt owed to the Kapoor Trust. On October 6, 2004, the Company received
a notice from NeoPharm indicating that an event of default had occurred on the NeoPharm Note. The
notice stated that an event of default was triggered when the processing agreement between NeoPharm
and the Company, which was contractually obligated to go into effect on or before October 1, 2004,
failed to occur. The processing agreement failed to become effective, in part, because of the
Companys inability to remove the sanctions imposed by the FDA on its Decatur manufacturing
facility.
The event of default under the NeoPharm Note also triggered a cross-default provision under
the Convertible Note Agreement and the Credit Facility. The Kapoor Trust waived the cross-default.
On October 8, 2004, the Company entered into a Third Amendment to the Credit Facility which, among
other things, amended certain of the financial covenants and LaSalle Bank agreed to waive certain
events of default arising out of noncompliance with certain obligations, including noncompliance
arising from the event of default under the NeoPharm Note. Because of this default, the Company
recorded the $3,250,000 of debt and $362,000 of accrued interest as current obligations as of
December 31, 2004. On May 16, 2005, the Company paid all principal and interest due under the
NeoPharm Note with a one-time cash payment of $2,500,000 and terminated the processing agreement
between NeoPharm and the Company. This settlement generated a gain of $1,212,000 in 2005 which is
included in Other Income in the Companys Consolidated Statement
47
of Operations. On May 13, 2005, the Company entered into a Waiver and Consent to Credit Agreement
with LaSalle Bank pursuant to which LaSalle Bank agreed to waive events of default arising out of
the Companys noncompliance with its obligations under the Credit Facility resulting from its
pay-off of the NeoPharm Note.
As part of the Exchange Transaction, the Company issued the 2003 Subordinated Notes to the
Kapoor Trust, Arjun Waney and Argent Fund Management, Ltd. in the amount of $2,767,000. The 2003
Subordinated Notes were to mature on April 7, 2006 and bore interest at prime plus 1.75% but
interest payments were prohibited under the terms of a subordination arrangement between LaSalle
and the note holders. The 2003 Subordinated Notes were subordinate to the Credit Facility but
senior to the Convertible Note Agreement. The Company also issued warrants (the Note Warrants) to
the holders of the 2003 Subordinated Notes to purchase an aggregate of 276,714 shares of common
stock with an exercise price of $1.10 per share. On March 20, 2006 the Company retired the 2003
Subordinated Notes with a cash payment of $3,288,000 which included the original $2,767,000
principal balance plus the accrued interest up to the date of payment. The 2003 Subordinated Notes
warrants to purchase 276,714 shares of common stock were exercised on a cashless basis during 2006.
The net common stock issuance was 199,412 shares.
The Company, in accordance with APB Opinion No. 14, recorded the initial issuance of the 2003
Subordinated Notes and Note Warrants as separate securities. The fair value of the Note Warrants
was estimated on the date of issuance using the modified Black-Scholes option pricing model with
the following assumptions: (i) dividend yield of zero, (ii) expected volatility of 127.5%, (iii)
risk free rate of 2.19%, and (iv) expected life of 3 years. As a result, the Company assigned a
value of $336,000 to Note Warrants and recorded this amount in shareholders equity and as a
discount, along with the spread between the face value of the debt and its initial recorded value
as described above, on the 2003 Subordinated Notes. Related debt discount amortization was
$114,000, $509,000, and $373,000 in 2006, 2005 and 2004, respectively.
In June 1998, the Company entered into a $3,000,000 mortgage agreement with Standard Mortgage
Investors, LLC of which there were outstanding borrowings of $602,000 and $938,000 at December 31,
2006 and 2005, respectively. The principal balance is payable over 10 years, with the final payment
due in June 2008. The mortgage note bears a fixed interest rate of 7.375% and is secured by the
real property located in Decatur, Illinois.
On March 8, 2006 the Company issued 4,311,669 shares of its common stock in a private
placement with various investors at a price of $4.50 per share which included warrants to purchase
1,509,088 additional shares of common stock. The warrants are exercisable for a five year period at
an exercise price of $5.40 per share and may be exercised by cash payment of the exercise price or
by means of a cashless exercise. The aggregate offering price of the private placement was
approximately $19,402,000 and the net proceeds to the Company, after payment of approximately
$1,324,000 of commissions and expenses, was approximately $18,078,000. The net proceeds were
allocated based on the relative fair market values of the common stock and warrants with
$16,257,000 allocated to the common stock and $1,821,000 allocated to the warrants.
In September 2006, the Company issued 1,000,000 shares of its common stock in a private
placement with Serum Institute of India, Ltd. at a price of $3.56 per share. The offering price was
$3,560,000 and the net proceeds to the Company, after payment of approximately $17,000 in expenses,
was approximately $3,543,000.
Note H Preferred Stock
Prior to conversion, the Series A Preferred Stock accrued dividends at a rate of 6.0% per
annum, which rate was fully cumulative, accrued daily and compounded quarterly. While the dividends
could be paid in cash at the Companys option, such dividends were deferred and added to the Series
A Preferred Stock balance. All shares of Series A Preferred Stock had liquidation rights in
preference over junior securities, including the common stock, and had certain anti-dilution
protections. The Series A Preferred Stock and unpaid dividends were convertible at any time into a
number of shares of common stock equal to the quotient obtained by dividing (x) $100 per share plus
any accrued but unpaid dividends on that share by (y) $0.75, as such numbers could be adjusted from
time to time pursuant to the terms of the Companys Restated Articles of Incorporation. All shares
of Series A Preferred Stock were to convert to shares of common stock on the earlier of (i) October
8, 2006 and (ii) the date on which the closing price per share of common stock for at least 20
consecutive trading days immediately preceding such date exceeded $4.00 per share. Until the
Companys shareholders approved certain provisions regarding the Series A Preferred Stock (the
Stockholders Approval), which occurred in July 2004, the Series A Preferred Stock had a mandatory
redeemable feature in October 2011.
Holders of Series A Preferred Stock had full voting rights, with each holder entitled to a
number of votes equal to the number of shares of common stock into which its shares could be
converted. Holders of Series A Preferred Stock and common stock would vote together as a single
class on all matters submitted to a shareholder vote, except in cases where a separate vote of the
holders of Series
48
A Preferred Stock was required by law or by the Companys Restated Articles of Incorporation.
The Companys Restated Articles of Incorporation provide that the Company cannot take certain
actions, including (i) issuing additional Series A Preferred Stock or securities senior to or on
par with the Series A Preferred Stock, (ii) amending the Companys Restated Articles of
Incorporation or By-laws to alter the rights of the Series A Preferred Stock, (iii) effecting a
change of control or (iv) effecting a reverse split of the Series A Preferred Stock, without the
approval of the holders of 50.1% of the Series A Preferred Stock.
Immediately after the Exchange Transaction, the Investors held approximately 75% of the
aggregate voting rights represented by outstanding shares of common and Series A Preferred Stock.
After the Exchange Transaction and assuming the exercise of all outstanding conversion rights,
warrants and options to acquire common stock, the Investors would hold approximately 77% of the
common stock, on a fully-diluted basis. Prior to the Exchange Transaction, the Investors held
approximately 35% of the outstanding voting securities and would have held approximately 42% of the
common stock on a fully-diluted basis.
The initially recorded amount of the Series A Preferred Stock, as described in Note G, was
$5,174,000 below its stated value. The Company, up through the Stockholders Approval date, had been
accreting this difference over the time period from issuance to the mandatory redemption date in
October 2011. Accretion in 2004 and 2003 was $267,000 and $220,000, respectively.
Pursuant to FASB No. 150, Accounting for Certain Financial Instruments with Characteristics
of Both Liabilities and Equity, as amended, the Series A Preferred Stock was originally reflected
as a liability because of its mandatory redemption feature. That characterization remained through
July 8, 2004 and as such, dividends were reflected as interest expense in the statement of
operations through July 8, 2004. As a result of the Stockholders Approval on July 8, 2004, the
carrying value of the Series A Preferred Stock was reclassified into shareholders equity and
subsequent accretion and dividends were reflected as adjustments to accumulated deficit and are
shown in the financial statements as impacting income (loss) available to common stockholders.
Additionally, and in accordance with EITF Abstract No. 00-27, the Company also recorded in July
2004 the value of the conversion option imbedded at issuance in each share of Series A Preferred
Stock, subject to limitations described in the EITF abstract. That value, approximately
$20,874,000, reduced the carrying value of the Series A Preferred Stock to near zero with an
offsetting credit to common stock. The carrying value of the Series A Preferred Stock was then
adjusted to its full aggregated stated value, plus unpaid dividends (approximately $26,552,000)
with a charge directly to accumulated deficit. That charge did not impact net earnings for the
third quarter of 2004, but substantially reduced earnings available to common stockholders and
earnings per share for that period.
As set forth in the Companys Restated Articles of Incorporation, all outstanding shares of
Series A Preferred Stock immediately and automatically converted into shares of Common Stock on the
day after the closing price per share of the Common Stock exceeded $4.00 for 20 consecutive trading
days. The closing price per share of the Common Stock as reported on the American Stock Exchange
exceeded $4.00 for 20 consecutive trading days as of the close of the market on January 12, 2006.
Consequently, on January 13, 2006 all 241,122 of the Companys outstanding shares of Series A
Preferred Stock automatically converted into an aggregate of 36,796,755 shares of Common Stock. No
shares of Series A Preferred Stock remain outstanding after this conversion.
On August 23, 2004, the Company issued an aggregate of 141,000 shares of Series B 6.0%
Participating Preferred Stock (Series B Preferred Stock) at a price of $100 per share, that was
convertible into common stock at a price of $2.70 per share, to certain investors, with warrants to
purchase 1,566,667 additional shares of common stock exercisable until August 23, 2009, with an
exercise price of $3.50 per share (the Series B Warrants) The net proceeds to the Company after
payment of investment banker fees and expenses and other transaction costs of approximately
$1,056,000 were approximately $13,044,000. A portion of the proceeds was used to pay off the Term
Loans and reduce the Revolver to zero. Remaining proceeds were used for working capital and other
general corporate purposes, including validation testing of the Companys Lyophilization facility.
In accounting for the issuance of the Series B Preferred Stock and Series B Warrants in 2004, the
Company recorded additional charges directly to accumulated deficit of $5,998,000. That charge did
not impact net earnings in 2004, but substantially reduced earnings available to common
stockholders and earnings per share for that period.
As required under the terms of the Series B Preferred Stock, the Company completed a
registration with the Securities and Exchange Commission in October 2004 of the common shares into
which the Series B Preferred Stock were convertible. Due to that registration, the holders of the
Series B Preferred Stock could no longer put their shares back to the Company. Accordingly, the
Series B Preferred Stock was reclassified into equity from debt in October 2004.
Immediately after the private placement, the purchasers of Series B Preferred Stock held
approximately 31% of the aggregate voting rights represented by outstanding shares of common stock
and Preferred Stock. After the private placement and assuming the exercise of all outstanding
conversion rights, warrants and options to acquire common stock, the purchasers of Series B
Preferred Stock would hold approximately 9% of the common stock, on a fully-diluted basis. Prior to
the private placement, the purchasers of
49
Series B Preferred Stock held approximately 5% of the outstanding voting securities and would
have held approximately 18% of the common stock on a fully-diluted basis.
Prior to its conversion, the Series B Preferred Stock accrued dividends at a rate of 6.0% per
annum, which rate was fully cumulative, accrued daily and compounded quarterly. While the dividends
could be paid in cash at the Companys option, such dividends were deferred and added to the Series
B Preferred Stock balance. Each share of Series B Preferred Stock, and accrued and unpaid dividends
with respect to each such share, was convertible by the holder thereof at any time into a number of
shares of our common stock equal to the quotient obtained by dividing (x) $100 plus any accrued but
unpaid dividends on such share by (y) $2.70, as such numerator and denominator could be adjusted
from time to time pursuant to the anti-dilution provisions of the Companys Restated Articles of
Incorporation governing the Series B Preferred Stock. The Company had the option of converting all
shares of Series B Preferred Stock into shares of the Companys common stock on any date after
August 23, 2005 as to which the closing price per share of the common stock for at least 20
consecutive trading days immediately preceding such date exceeds $5.00 per share. The closing price
per share of the common stock as reported on the American Stock Exchange exceeded $5.00 for 20
consecutive trading days as of the close of the market on December 13, 2006. Consequently, all
66,000 outstanding shares of Series B Preferred Stock immediately and automatically converted into
an aggregate of 2,804,800 shares of common stock on December 14, 2006. As of December 31, 2006, no
shares of Series B Preferred Stock remain outstanding.
Note I Leasing Arrangements
The Company leases real and personal property in the normal course of business under various
operating leases, including non-cancelable and month-to-month agreements. Payments under these
leases were $1,361,000, $1,696,000, and $1,549,000 for the years ended December 31, 2006, 2005, and
2004, respectively.
The following is a schedule, by year, of future minimum rental payments required under
non-cancelable operating leases (in thousands):
|
|
|
|
|
Year ending December, 31 |
|
|
|
|
2007 |
|
$ |
1,125 |
|
2008 |
|
|
1,166 |
|
2009 |
|
|
1,209 |
|
2010 and thereafter |
|
|
7,135 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
10,635 |
|
|
|
|
|
Note J Stock Options, Employee Stock Purchase Plan and Restricted Stock
Under the 1988 Incentive Compensation Program (the Incentive Program) which expired November
2, 2003, any officer or key employee of the Company was eligible to receive options as designated
by the Companys Board of Directors. The exercise price of the options granted under the Incentive
Program were not to be less than 50 percent of the fair market value of the shares subject to the
option on the date of grant, as determined by the Board of Directors. All options granted under the
Incentive Program during the years ended December 31, 2003 and 2002 have exercise prices equivalent
to the market value of the Companys common stock on the date of grant. Options granted under the
Incentive Program generally vest over a period of three years and expire within a period of five
years. Under the Amended and Restated Akorn, Inc. 2003 Stock Option Plan (the Amended 2003 Plan),
3,845,000 options have been granted to employees. These options generally vest over a period of
three years and expire within a period of five years.
Under the 1991 Stock Option Plan for Directors (the Directors Plan), which expired in
December 7, 2001, persons elected as directors of the Company were granted nonqualified options at
the fair market value of the shares subject to option on the date of the grant. Options granted
under the Directors Plan vested immediately and expire five years from the date of grant. Under
the 2003 Plan, 85,000 options have been granted to directors. The Amended 2003 Plan was approved by
the shareholders in May 2005.
Effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards No.
123 (revised 2004), Share Based Payment (SFAS 123(R)), applying the modified prospective method.
Prior to the adoption of SFAS 123(R), the Company applied the provisions of APB Opinion No. 25,
Accounting for Stock Issued to Employees, in accounting for its stock-based awards, and
accordingly, recognized no compensation cost for its stock plans other than for its restricted
stock awards.
Under the modified prospective method, SFAS 123(R) applies to new awards and to awards that
were outstanding as of December 31, 2005 that are subsequently vested, modified, repurchased or
cancelled. Compensation expense recognized during 2006 includes the portion vesting during the
period for (1) all share-based payments granted prior to, but not yet vested as of December 31,
50
2005, based on the grant date fair value estimated in accordance with the original provisions
of Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation
(SFAS 123) and (2) all share-based payments granted subsequent to December 31, 2005, based on the
grant-date fair value estimated using the Black-Scholes option-pricing model. The Company has
calculated its available APIC pool of net excess benefits using the alternative transition method
as defined in FASB 123R-3.
Stock option compensation expense of $1,229,000 was recognized during the year ended December
31, 2006. As a result of the Companys decision to adopt the modified prospective method, prior
period results have not been restated. For awards issued prior to January 1, 2006, the Company used
the multiple award method for allocating the compensation cost to each period. For awards issued on
or after January 1, 2006, concurrent with the adoption of SFAS 123(R), the Company has elected to
use the single-award method for allocating the compensation cost to each period.
Had compensation cost for the Companys stock-based compensation plans been determined based
on SFAS No. 123, the Companys loss and net loss per share for the years ended December 31, 2005
and 2004 would have been the pro forma amounts indicated below (in thousands, except for per share
data).
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
|
Net income (loss) as reported |
|
$ |
(8,609 |
) |
|
$ |
(3,026 |
) |
Add: stock-based employee compensation expense included in reported net income |
|
|
407 |
|
|
|
|
|
Deduct: total stock-based employee compensation expense determined under
fair-value-based method for all awards |
|
|
(1,441 |
) |
|
|
(3,223 |
) |
|
|
|
Pro forma net income (loss) |
|
|
(9,643 |
) |
|
|
(6,259 |
) |
Deduct: preferred stock dividends and adjustments |
|
|
(4,082 |
) |
|
|
(34,436 |
) |
|
|
|
Pro forma net loss available for common stockholders |
|
$ |
(13,725 |
) |
|
$ |
(40,695 |
) |
|
|
|
Basic and diluted loss per share of common stock |
|
|
|
|
|
|
|
|
Shares used in Computing Net Loss Per Share |
|
|
26,095 |
|
|
|
20,817 |
|
As reported |
|
$ |
(0.49 |
) |
|
$ |
(1.80 |
) |
Pro forma |
|
$ |
(0.53 |
) |
|
$ |
(1.95 |
) |
A summary of stock based compensation activity within the Companys stock-based compensation
plans for the year ended December 31, 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
Number of |
|
Weighted |
|
Remaining |
|
|
|
|
Shares |
|
Average |
|
Contractual Term |
|
Aggregate |
|
|
(in thousands) |
|
Exercise Price |
|
(Years) |
|
Intrinsic Value |
|
Outstanding at January 1, 2006 |
|
|
3,706 |
|
|
$ |
2.54 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,037 |
|
|
$ |
4.71 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1,300 |
) |
|
$ |
2.06 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(288 |
) |
|
$ |
3.91 |
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2006 |
|
|
3,155 |
|
|
$ |
3.22 |
|
|
|
2.9 |
|
|
$ |
9,560 |
|
|
Vested or expected to vest at December 31, 2006 |
|
|
3,040 |
|
|
$ |
3.18 |
|
|
|
0.3 |
|
|
$ |
9,334 |
|
|
Exercisable at December 31, 2006 |
|
|
2,130 |
|
|
$ |
2.69 |
|
|
|
2.4 |
|
|
$ |
7,583 |
|
|
The aggregate intrinsic value for stock options outstanding and exercisable is defined as
the difference between the market value of the Companys common stock as of the end of the period
and the exercise price of the stock options. The total intrinsic value of stock options exercised
was $3,917,000, $848,000 and $288,000 for the years ended December 31, 2006, 2005, and 2004,
respectively. As a result of the stock options exercised, the Company recorded cash received and
additional paid-in-capital of $1,672,000, $1,287,000, and $1,233,000 during the years ended
December 31, 2006, 2005, and 2004, respectively.
As of December 31, 2006, the total amount of unrecognized compensation cost related to
nonvested stock options was $1,157,000 which is expected to be recognized as expense over a
weighted-average period of 1.2 years.
51
Under both SFAS 123(R) and the fair value method of accounting under SFAS 123 (SFAS 123 Pro
Forma), the fair value of stock options granted is determined using the Black-Scholes model. The
Companys expected volatility was based on the historical volatility of its stock. The expected
life assumption is based on historical employee exercise patterns and employee post-vesting
termination behavior. The risk-free interest rate for the expected term of the option is based on
the average market rate on U.S. treasury securities in effect during the quarter in which the
options were granted. The dividend yield reflects historical experience as well as future
expectations over the expected term of the option. Also, SFAS No. 123(R) requires an estimate of
forfeitures at the time of grant and revision in subsequent periods, if necessary, if actual
forfeitures differ from those estimates. After reviewing historical forfeiture information, the
Company has decided to use 10% as an estimated forfeiture rate. The assumptions used in
estimating the fair value of the stock options granted during the period, along with the
weighted-average grant date fair values, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
2006 |
|
(SFAS 123 |
|
(SFAS 123 |
|
|
(SFAS 123(R)) |
|
Pro Forma) |
|
Pro Forma) |
|
|
|
Expected Volatility |
|
|
45% - 62 |
% |
|
|
59% - 83 |
% |
|
|
95 |
% |
Expected Life (in years) |
|
|
3.5 - 3.7 |
|
|
|
5.0 |
|
|
|
5.0 |
|
Risk-free interest rate |
|
|
4.6% - 5.0 |
% |
|
|
3.9% - 4.4 |
% |
|
|
3.4 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
|
|
|
|
Fair value per stock option |
|
$ |
1.89 |
|
|
$ |
1.70 |
|
|
$ |
2.05 |
|
The Akorn, Inc. Employee Stock Purchase Plan permits eligible employees to acquire shares of
the Companys common stock through payroll deductions not exceeding 15% of base wages, at a 15%
discount from market price. A maximum of 1,000,000 shares of the Companys common stock may be
acquired under the terms of the Plan. New shares issued under the plan approximated 42,000 in 2006,
34,000 in 2005 and 44,000 in 2004.
The Company also grants restricted stock awards to certain employees. Restricted stock awards
are valued at the closing market value of the Companys common stock on the day of grant, and the
total value of the award is recognized as expense ratably over the vesting period of the employees
receiving the grants. As of December 31, 2006, the total amount of unrecognized compensation
expense related to nonvested restricted stock awards was $1,178,000. The Company recognized
compensation expense of $719,000 and $407,000 during the years ended December 31, 2006 and 2005,
respectively, related to outstanding restricted stock awards.
On April 20, 2006, the Company granted 350,000 shares of restricted stock to certain officers.
The market value was $5.05 per share on that date and the Company recorded $1,767,500 as deferred
compensation expense. The shares fully vest on April 20, 2009 and $589,000 was recorded as
compensation expense in 2006.
The following is a summary of nonvested restricted stock activity:
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
Weighted Average |
|
|
(in thousands) |
|
Grant Date Fair Value |
|
Nonvested at December 31, 2005 |
|
|
208 |
|
|
$ |
2.61 |
|
Granted |
|
|
350 |
|
|
$ |
5.05 |
|
Vested |
|
|
(206 |
) |
|
$ |
2.61 |
|
Canceled |
|
|
(2 |
) |
|
$ |
2.61 |
|
|
Nonvested at December 31, 2006 |
|
|
350 |
|
|
$ |
5.05 |
|
|
Note K Income Taxes
The income tax provision (benefit) consisted of the following (in thousands):
52
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current |
|
|
Deferred |
|
|
Total |
|
Year ended December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
State |
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
3 |
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
15 |
|
|
$ |
|
|
|
$ |
15 |
|
State |
|
|
2 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
17 |
|
|
$ |
|
|
|
$ |
17 |
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
6 |
|
|
$ |
|
|
|
$ |
6 |
|
State |
|
|
2 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8 |
|
|
|
|
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
Income tax expense (benefit) differs from the expected tax expense (benefit) computed by
applying the U.S. Federal corporate income tax rate of 34% to income before income taxes as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Computed expected tax expense (benefit) |
|
$ |
(2,027 |
) |
|
$ |
(2,922 |
) |
|
$ |
(1,027 |
) |
Change in income taxes resulting from: |
|
|
|
|
|
|
|
|
|
|
|
|
State income taxes, net of federal income tax |
|
|
(287 |
) |
|
|
(414 |
) |
|
|
(145 |
) |
Nondeductible preferred stock accretion and other permanent differences |
|
|
(543 |
) |
|
|
161 |
|
|
|
926 |
|
Valuation allowance change |
|
|
2,860 |
|
|
|
3,192 |
|
|
|
254 |
|
|
|
|
|
|
|
|
|
|
|
Income tax expense (benefit) |
|
$ |
3 |
|
|
$ |
17 |
|
|
$ |
8 |
|
|
|
|
|
|
|
|
|
|
|
Net deferred income tax assets at December 31, 2006 and 2005 include (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Deferred income tax assets: |
|
|
|
|
|
|
|
|
Other accrued expenses |
|
$ |
839 |
|
|
$ |
826 |
|
Intangible assets |
|
|
649 |
|
|
|
750 |
|
Net operating loss carry forward |
|
|
15,756 |
|
|
|
13,475 |
|
Other |
|
|
3,730 |
|
|
|
3,128 |
|
|
|
|
|
|
|
|
|
|
|
20,974 |
|
|
|
18,179 |
|
|
|
|
|
|
|
|
Valuation allowance |
|
|
(20,192 |
) |
|
|
(17,332 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
782 |
|
|
|
847 |
|
Deferred income tax liabilities: |
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
(782 |
) |
|
|
(847 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The Company records a valuation allowance to reduce the deferred income tax assets to the
amount that is more likely than not to be realized. In performing its analysis of whether a
valuation allowance to reduce the deferred income tax asset was necessary, the Company evaluated
the data and determined the amount of the net deferred income tax assets that are more likely than
not to be realized. Based upon its analysis, the Company established a valuation allowance to
reduce the net deferred income tax assets to zero. The Company has net operating loss carry
forwards of approximately $40 million expiring from 2021 through 2026.
Note L Retirement Plan
All employees who have attained the age of 21 are eligible for participation in the Companys
401(k) Plan. The plan-related expense for the years ended December 31, 2006, 2005, and 2004,
totaled $344,000, $311,000, and $276,000, respectively. The employers matching contribution is a
percentage of the amount contributed by each employee and is funded on a current basis.
53
Note M Segment Information
The Company classifies its operations into three business segments, ophthalmic, hospital drugs
and injectables, and contract services. The ophthalmic segment manufactures, markets and
distributes diagnostic and therapeutic pharmaceuticals. The hospital drugs and injectables segment
manufactures, markets and distributes drugs and injectable pharmaceuticals, primarily in niche
markets. This segment was previously classified as the injectable segment, however the Company
recently changed the classification to reflect that an increasing amount of pharmaceuticals
delivered by the Company to hospitals are drugs other than injectable pharmaceuticals. The new
classification reflects that the segment includes both drugs and injectable pharmaceuticals. The
contract services segment manufactures products for third party pharmaceutical and biotechnology
customers based on their specifications. The Companys basis of accounting in preparing its segment
information is consistent with that used in preparing its consolidated financial statements.
Selected financial information by industry segment is presented below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmic |
|
$ |
19,528 |
|
|
$ |
22,659 |
|
|
$ |
29,812 |
|
Hospital Drugs & Injectables |
|
|
42,489 |
|
|
|
13,719 |
|
|
|
12,341 |
|
Contract Services |
|
|
9,233 |
|
|
|
8,106 |
|
|
|
8,555 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
71,250 |
|
|
$ |
44,484 |
|
|
$ |
50,708 |
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmic |
|
$ |
6,069 |
|
|
$ |
8,069 |
|
|
$ |
14,486 |
|
Hospital Drugs and Injectables |
|
|
18,114 |
|
|
|
5,740 |
|
|
|
3,288 |
|
Contract Services |
|
|
2,697 |
|
|
|
1,135 |
|
|
|
428 |
|
|
|
|
|
|
|
|
|
|
|
Total gross profit |
|
|
26,880 |
|
|
|
14,944 |
|
|
|
18,202 |
|
Operating expenses |
|
|
31,785 |
|
|
|
22,423 |
|
|
|
18,570 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(4,905 |
) |
|
|
(7,479 |
) |
|
|
(368 |
) |
Interest, Debt Retirement gain/(expense) & Other income (expense) |
|
|
(1,055 |
) |
|
|
(1,113 |
) |
|
|
(2,650 |
) |
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
$ |
(5,960 |
) |
|
$ |
(8,592 |
) |
|
$ |
(3,018 |
) |
|
|
|
|
|
|
|
|
|
|
The Company manages its business segments to the gross profit level and manages its operating
and other costs on a company-wide basis. Intersegment activity at the gross profit level is
minimal. The Company does not identify assets by segment for internal purposes, as certain
manufacturing and warehouse facilities support more than one segment.
Note N Commitments and Contingencies
(i) The FDA issued a Warning Letter to the Company in October 2000 following a routine
inspection of its Decatur manufacturing facility. Since 2000, and in response to the violations cited by the FDA, The Company implemented a
comprehensive systematic corrective action plan at its Decatur manufacturing facility. The Company
maintained regular communications with the FDA and provided periodic
progress reports. During this time, the FDA initiated no enforcement action. On December 13, 2005, the FDA notified the Company that it had satisfactorily implemented
corrective actions and the FDA had determined that its Decatur manufacturing facility was in
substantial compliance with cGMP regulations. Consequently, the restrictions of the Warning Letter
were removed and the Company became eligible for new product approvals for products manufactured at
its Decatur manufacturing facility. While under the Warning Letter restrictions from 2000 to 2005, the inability to fully utilize
the capabilities of the Decatur manufacturing facility had a material adverse effect on the
business, financial condition and results of operations of the Company.
(ii) On October 8, 2003, the Company, pursuant to the terms of the Letter Agreement dated
September 26, 2002 between the Company and AEG Partners LLC (AEG), terminated AEG. On August 2
and 3, 2004, the Company and AEG participated in a mandatory and binding arbitration hearing. The
arbitrator took the matter under submission and rendered his decision dated August 19, 2004, which
was received on August 23, 2004. The arbitrators decision directed the following: (1) payment to
AEG for the sum of $300,000, plus interest of 5% per annum from October 7, 2003 (approximately
$13,479), (2) issuance of warrants to AEG to purchase 1,250,000 shares of our common stock at an
exercise price of $0.75 per share, and (3) denial of AEGs request that the Company pay AEGs
attorneys fees and costs. As a result of the arbitrators decision, the Company reported a
one-time net gain of approximately $295,000 in the third quarter of 2004. It was determined none of
the anti-dilution provisions in our outstanding securities were triggered by the issuance of the
AEG Warrants. AEG exercised 200,000 warrants during the year ended December 31, 2006 and has
800,000 warrants remaining as of December 31, 2006.
(iii) The Company is a party in other legal proceedings and potential claims arising in the
ordinary course of its business. The amount, if any, of ultimate liability with respect to such
matters cannot be determined. Despite the inherent uncertainties of litigation, management of the
Company at this time does not believe that such proceedings will have a material adverse impact on
the financial condition, results of operations, or cash flows of the Company.
Note O Supplemental Cash Flow Information (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2006 |
|
2005 |
|
2004 |
Interest and taxes paid: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest (net of amounts capitalized) |
|
$ |
593 |
|
|
|
419 |
|
|
$ |
434 |
|
Income taxes |
|
|
2 |
|
|
|
72 |
|
|
|
2 |
|
Note: In March 2006, $7,298 in principal and interest related to convertible notes was retired by
conversion to the common stock of Akorn, Inc.
Note P Recent Accounting Pronouncements
In February 2006, the Financial Accounting Standard Board (FASB) issued SFAS No. 155,
Accounting for Certain Hybrid Financial Instruments An Amendment of FASB Statements No. 133 and
140. This statement amends SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities, and No. 140, Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities. SFAS No. 155 permits fair value remeasurement for any hybrid
financial instrument that contains an embedded derivative that otherwise would require bifurcation.
This statement also establishes a requirement to evaluate interests in securitized financial assets
to identify interests that are freestanding derivatives or that are hybrid financial instruments
that contain an embedded derivative requiring bifurcation. SFAS No. 155 is effective for all
financial instruments acquired, issued, or subject to a remeasurement event occurring in fiscal
years beginning after December 15, 2006. The Company does not expect that the adoption of SFAS No.
155 will have a significant impact on its consolidated financial statements.
In September 2005, the EITF reached a consensus on Issue No. 05-8, Income Tax Consequences of
Issuing Convertible Debt with a Beneficial Conversion Feature. Under EITF 05-8, the issuance of
convertible debt with a beneficial conversion feature results in a temporary difference for
purposes of applying Statement 109. The deferred taxes recognized for the temporary difference
should be recorded as an adjustment to paid-in capital. EITF 98-5 Accounting for Convertible
Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios and
EITF 00-27 Application of Issue No. 98-5 to Certain Convertible Instruments require that the
non-detachable conversion feature of a convertible debt security be accounted for separately if it
is a beneficial conversion feature. A beneficial conversion feature is recognized and measured by
allocating to additional paid-in capital a portion of the proceeds equal to the conversion
features intrinsic value. A discount on the convertible debt is recognized for the amount that is
allocated to additional paid-in capital. The debt discount is accreted from the date of issuance to
the stated redemption date of the convertible instrument or through the earliest conversion date if
the instrument does not have a stated redemption date. The U.S. Federal Income Tax Code includes
the entire amount of proceeds received at issuance as the tax basis of the convertible debt
security. The EITF 05-8 Consensus should be applied retrospectively to all instruments with a
beneficial conversion feature accounted for
under EITF 98-5 and EITF 00-27 for periods beginning after December 15, 2005. The adoption of
EITF 05-8 did not have a material impact on the Companys financial statements.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections (SFAS
154), which replaces APB Opinion No. 20, Accounting Changes and SFAS No. 3, Reporting Accounting
Changes in Interim Financial Statements. SFAS 154 retained accounting guidance related to changes
in estimates, changes in a reporting entity and error corrections. However, changes in
55
accounting
principles must be accounted for retrospectively by modifying the financial statements of prior
periods unless it is impracticable to do so. SFAS 154 is effective for accounting changes made in
fiscal years beginning after December 15, 2005. The adoption of SFAS 154 did not have a material
impact on the Companys financial position, results of operations or cash flows.
In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No.
123R), which revises and replaces SFAS No. 123, Accounting for Stock-Based Payments and supersedes
APB Opinion No. 25, Accounting for Stock Issued to Employees (APB 25). SFAS 123R requires the
measurement of all share-based payments to employees, including grants of employee stock options,
using a fair-value based method and the recording of such expense in its consolidated statements of
operations. The pro forma disclosures previously permitted under SFAS No. 123 will no longer be an
alternative to financial statement recognition. The provisions for SFAS No. 123R are effective for
the first interim or annual reporting period beginning after June 15, 2005. The Company has
adopted SFAS No. 123R effective January 1, 2006.
SFAS 123R permits public companies to adopt its requirements using one of two methods. The
first adoption method is a modified prospective method in which compensation cost is recognized
beginning with the effective date (i) based on the requirements of SFAS 123R for all share-based
payments granted after the effective date and (ii) based on the requirements of SFAS 123 for all
awards granted to employees prior to the effective date of SFAS 123R that remain unvested on the
effective date. The second adoption method is a modified retrospective method, which includes the
requirements of the modified prospective method described above, but also permits entities to
restate, based on the amounts previously recognized under SFAS 123 for purposes of pro forma
disclosures, either (i) all prior periods presented or (ii) prior interim periods in the year of
adoption.
The Company elected the modified prospective method and did not restate prior year amounts.
The adoption of SFAS 123Rs fair value method had a significant impact on the results of
operations, although it had no impact on the Companys overall financial position. However, had the
Company adopted SFAS 123R in prior years, the impact of that adoption would have approximated the
impact of SFAS 123, as described in the disclosure of pro forma net earnings and pro forma earnings
per share.
In November 2005, the FASB issued FASB Staff Position (FSP) No. 123(R)-3, Transition Election
Related to Accounting for Tax Effects of Share-Based Payment Awards (FSP 123(R)-3). The Company
elected to adopt the alternative transition method provided in FSP 123(R)-3 for calculating the tax
effects of stock-based compensation pursuant to SFAS 123-(R).
In June 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the
accounting for uncertainty in income taxes by prescribing a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. The interpretation also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, and disclosure. FIN 48 is
effective January 1, 2007. The Company is in the process of evaluating the impact that FIN 48 will
have on its Consolidated Financial Statements. At this time the Company does not believe that
adoption of FIN 48 will have a material impact on its financial position, results of operations or
cash flows.
In September 2006 the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157), which
provides guidance on how to measure assets and liabilities that use fair value. SFAS 157 will
apply whenever another U.S. GAAP standard requires (or permits) assets or liabilities to be
measured at fair value but does not expand the use of fair value to any new circumstances. This
standard will also require additional disclosures in both annual and quarterly reports. SFAS 157
will be effective for financial statements issued for fiscal years beginning after November 15,
2007. The adoption of SFAS 157 is not expected to have a material impact on the Companys results
of operations or financial position.
In September 2006, the SEC issued SAB No. 108, Considering the Effects of Prior Year
Misstatements when Quantifying Misstatements in Current Year Financial Statements. This Bulletin
addresses quantifying the financial statement effects of misstatements, including how the effects
of prior year uncorrected errors must be considered in quantifying misstatements in the current
year financial statements. This Bulletin is effective for fiscal years ending after November 15,
2006 and allows for a one-time transitional cumulative effect adjustment to beginning retained
earnings in the fiscal year adopted for errors that were not previously
deemed material, but are material under the guidance in SAB No. 108. The adoption of this
Bulletin did not have a material impact on the Companys financial statements.
56
Note Q Business Alliances
On April 21, 2004, the Company announced the signing of a memo of understanding with Strides
Arcolab Limited (Strides), a pharmaceutical manufacturer based in India. As a result of
negotiations following the execution of the memo of understanding, on September 22, 2004, the
Company entered into agreements with Strides for the development, manufacturing and marketing of
grandfathered products, patent-challenge products and ANDA products for the U.S. hospital and
retail markets. The joint venture operates in the form of a Delaware limited liability company,
Akorn-Strides, LLC (the Joint Venture Company). Strides will be responsible for developing,
manufacturing and supplying products under an OEM Agreement between it and the Joint Venture
Company. The Company will be responsible for sales and marketing of the products under an exclusive
Sales and Marketing Agreement with the Joint Venture Company. Strides and Akorn each own 50% of the
Joint Venture Company with equal management representation. Each contributed $1,250,000 in capital,
to be used to finance the preparation of ANDAs by Strides. As of December 31, 2004, the Company had
funded its $1,250,000 capital contribution to the Joint Venture Company. In February 2005, the
Company loaned an additional $1,250,000 to the Joint Venture Company that was advanced to Strides
to finance its capital contribution. Strides repaid this loan to the Company in December 2005.
Under the OEM Agreement, the respective contributions were advanced to Strides to finance the
preparation, development and filing with the FDA of ANDAs for generic drugs based on a mutually
agreed development schedule. The Joint Venture Company will have exclusive rights to FDA approved
generic drugs within the United States hospital, medical clinic, physician group and other
wholesale drug markets. If both managers agree, Strides and Akorn may make additional equivalent
capital contributions to finance subsequent ANDA preparation costs under a similar arrangement to
its initial capital contributions, including an additional loan by the Company to the Joint Venture
Company to finance Strides capital contribution. In 2005, Strides and the Company each contributed
$250,000 for additional ANDA development work. Pursuant to the requirements of FIN 46(R), because
the Company funded Strides capital contribution (even though that funding was supported by a
letter of credit ultimately in the Companys favor), the Company was required to consolidate the
Joint Venture Company until such time as its loan was collected. Accordingly, in the Companys
consolidated financial statements, its 2004 contribution to the Joint Venture Company was
eliminated. The advance of the initial $1,250,000 from the Joint Venture Company to Strides was
reflected as an other current asset and was amortized over the mutually agreed upon development
schedule period in 2004 and 2005. Because of this, the Company had recorded 100% of the Joint
Venture Company losses in its 2004 results of operations and the amortization expense for 2004 was
$375,000. In December 2005, the Company recorded a $1,250,000 reduction in its research and
development expense to recognize the change to a 50/50 loss sharing arrangement in line with the
Strides capital contribution in cash at risk in the Joint Venture Company. The total research and
development expense recorded by the Company related to the Joint Venture Company was $1,125,000 for
2005. Going forward, the Company will account for the Joint Venture Company earnings/losses on the
equity method of accounting in accordance with its 50% ownership interest.
On October 15, 2004, the Company entered into an agreement with Serum Institute of India, Ltd.
(Serum), in an exclusive drug development and distribution agreement for oncology and other
injectable drug products for the United States and Canada. Under the terms of the five-year
agreement Serum will develop and manufacture certain drug products and the Company will be
responsible for all regulatory submissions, will own the ANDAs and will buy the products from Serum
under a negotiated transfer price arrangement, which guarantees minimum annual purchases of
$1,000,000 per product in order to maintain exclusivity. Additionally, the Company will market and
sell the products in the United States and Canada under the Companys label.
On November 16, 2004, the Company entered into an agreement with Hameln Pharmaceuticals
(Hameln), a private German pharmaceuticals company, to license and supply to the Company two
Orphan Drug NDAs: Calcium-DTPA and Zinc-DTPA. The two drugs were approved on August 11, 2004 by
the FDA, and are indicated as antidotes for the treatment of radioactive poisoning. Sales for the
two drugs commenced in the fourth quarter of 2004. Under the agreement, Hameln provided the Company
an exclusive license for an initial term of five years with automatic successive two-year
extensions. The Company has paid a one-time 1,550,000 Euro ($2,095,000) license fee, which is
reflected as an intangible asset being amortized over a seven year period. The Company is
responsible for marketing and distributing both drugs in the U.S. and Canada. The Company will pay
Hameln the greater of 50% of its gross revenues or a minimum transfer price for the product. Hameln
will be responsible for the manufacturing of both drugs for the Company. The Company will be
responsible for the payment of any annual FDA establishment fees and for the cost of any post
approval studies.
On March 7, 2006 the Company entered into an exclusive drug manufacturing and supply agreement for
an oral anti-infective ANDA drug product with Cipla, Ltd., (Cipla) a leading Indian
pharmaceutical company located in Mumbai, India, Under the terms of the ten-year agreement, Cipla
will be responsible for the manufacturing and supply of the drug using the Companys formulation,
and the Company will be responsible for the ANDA regulatory submission and clinical development,
and for funding the purchase of specialized manufacturing equipment. The Company will pay Cipla
milestone fees for Ciplas assistance with ANDA development
57
and submission. Pursuant to the
agreement, the Company will purchase the product from Cipla and Cipla will supply the product to
the Company on an exclusive basis in the United States. The Company will own the ANDA in the
United States.
Note R Customer and Supplier Concentration
In 2006 the Company sold $25,464,000 of its radiation DTPA antidote products to the U.S.
Department of Health & Human Services (HHS) which represented 36% of its sales in 2006. There
were no sales to HHS in 2005. In addition, a small number of large wholesale drug distributors
account for a large portion of the Companys gross sales, revenues and accounts receivable.
AmerisourceBergen Health Corporation (Amerisource), Cardinal Health, Inc. (Cardinal) and
McKesson Drug Company (McKesson) are all distributors of the Companys products, as well as
suppliers of a broad range of health care products. The percentage impact that these customers had
on the Companys business as of and for the years ended as indicated is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
2004 |
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
Net |
|
Accts |
|
Gross |
|
Net |
|
Accts. |
|
Gross |
|
Net |
|
Accts |
|
|
Sales |
|
Revenue |
|
Receivable |
|
Sales |
|
Revenue |
|
Receivable |
|
Sales |
|
Revenue |
|
Receivable |
Amerisource |
|
|
13 |
% |
|
|
9 |
% |
|
|
12 |
% |
|
|
24 |
% |
|
|
16 |
% |
|
|
28 |
% |
|
|
14 |
% |
|
|
10 |
% |
|
|
17 |
% |
Cardinal |
|
|
19 |
% |
|
|
13 |
% |
|
|
24 |
% |
|
|
28 |
% |
|
|
19 |
% |
|
|
29 |
% |
|
|
25 |
% |
|
|
20 |
% |
|
|
51 |
% |
McKesson |
|
|
18 |
% |
|
|
11 |
% |
|
|
17 |
% |
|
|
17 |
% |
|
|
11 |
% |
|
|
19 |
% |
|
|
18 |
% |
|
|
16 |
% |
|
|
6 |
% |
No other customers accounted for more than 10% of gross sales, net revenues or gross
trade receivables for the indicated dates and periods.
If sales to Amerisource, Cardinal or McKesson were to diminish or cease, the Company believes
that the end users of its products would find little difficulty obtaining the Companys products
either directly from the Company or from another distributor.
In 2006, purchases from Hameln Pharmaceuticals represented approximately 13% of the Companys
purchases and in both 2005 and 2004, purchases from Cardinal Health PTS, LLC accounted for
approximately 17% of its purchases. The Company requires a supply of quality raw materials and
components to manufacture and package pharmaceutical products for its own use and for third parties
with which it has contracted. The principal components of the Companys products are active and
inactive pharmaceutical ingredients and certain packaging materials. Many of these components are
available from only a single source and, in the case of many of the Companys 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 the Companys development and marketing efforts. If for
any reason the Company is unable to obtain sufficient quantities of any of the raw materials or
components required to produce and package its products, it may not be able to manufacture its
products as planned, which could have a material adverse effect on the Companys business,
financial condition and results of operations.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
An evaluation was performed, under the supervision and with the participation of Company
management, including the Chief Executive Officer (CEO) and Chief Financial Officer (CFO), of
the effectiveness of the design and operation of the Companys
disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act
of 1934, as amended (the Act)). There are inherent limitations to the effectiveness of any
system of disclosure controls and procedures, including cost limitations, judgments used in
decision making, assumptions regarding the likelihood of future events, soundness of internal
controls, fraud, the possibility of human error and the circumvention or overriding of the controls
and procedures. Accordingly, even effective disclosure controls and procedures can provide only
reasonable, and not absolute, assurance of achieving their control objectives. Based on that
evaluation, management, including the CEO and CFO, has concluded that, as of December 31, 2006, the
Companys disclosure
58
controls and procedures were effective in all material respects at the
reasonable assurance level to ensure that information required to be disclosed in reports that the
Company files or submits under the Act is recorded, processed, summarized and timely reported in
accordance with the rules and forms of the SEC.
Managements Report on Internal Control Over Financial Reporting
Company management is responsible for establishing and maintaining adequate internal control over
financial reporting; as such term is defined in Rule 13a-15(f) under the Act. Under the
supervision and with the participation of Company management, including the CEO and CFO, an
evaluation was performed of the effectiveness of the Companys internal control over financial
reporting. The evaluation was based on the framework in Internal Control Integrated Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). There are
inherent limitations in the effectiveness of any internal control, including the possibility of
human error and the circumvention or overriding of controls. Accordingly, even effective internal
controls over financial reporting can provide only reasonable assurance with respect to financial
statement preparation. Further, because of changes in conditions, the effectiveness of internal
control may vary over time. Based on the evaluation under the framework in Internal Control
Integrated Framework issued by COSO, Company management concluded that the Companys internal
control over financial reporting was effective at the reasonable assurance level as of December 31,
2006.
Attestation Report of the Registered Public Accounting Firm
The Companys managements assessment of the effectiveness of its internal control over financial
reporting as of December 31, 2006 has been audited by BDO Seidman, LLP, an independent registered
public accounting firm, as stated in its report which appears above.
Changes in Internal Control Over Financial Reporting
In the fourth fiscal quarter ended December 31, 2006, there had been no change in the Companys
internal control over financial reporting that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
Item 9B. Other Information.
None.
59
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Incorporated by reference to the sections entitled I Proposals Proposal 1 Elections of
Directors, II Corporate Governance and Related Matters and IV Executive Compensation and
Other Information in the definitive proxy statement for the 2007 annual meeting.
Item 11. Executive Compensation.
Incorporated by reference to the sections entitled II Corporate Governance and Related Matters
Director Compensation and IV Executive Compensation and Other Information in the definitive
proxy statement for the 2007 annual meeting.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters.
Incorporated by reference to the section entitled III Security Ownership of Certain Beneficial
Owners and Management in the definitive proxy statement for the 2007 annual meeting.
Item 13. Certain Relationships and Related Transactions and Director Independence.
Incorporated by reference to the section entitled II Corporate Governance and Related Matters
Certain Relationships and Related Transactions in the definitive proxy statement for the 2007
annual meeting.
Item 14. Principal Accounting Fees and Services.
Incorporated by reference to the section entitled I Proposals Proposal 3. Ratification of
Selection of Independent Registered Public Accounting Firm in the definitive proxy statement for
the 2007 annual meeting.
60
PART IV
Item 15. Exhibits, Financial Statement Schedules
(a) |
|
(1) Financial Statements. The consolidated financial statements listed on the index to Item
8 of this Annual Report on Form 10-K are filed as a part of this Annual Report. |
|
(2) |
|
Financial Statement Schedules. All financial statement schedules have been omitted since
the information is either not applicable or required or is included in the financial
statements or notes thereof. |
|
|
(3) |
|
Exhibits. Those exhibits marked with a (*) refer to exhibits filed herewith. The other
exhibits are incorporated herein by reference, as indicated in the following list. Those
exhibits marked with a () refer to management contracts or compensatory plans or
arrangements. Portions of the exhibits marked with a (W) are the subject of a Confidential
Treatment Request Under 17 C.F.R. §§ 200.80(b)(4), 200.83 and 240.24b-2. |
|
|
|
Exhibit No. |
|
Description |
3.1
|
|
Restated Articles of Incorporation of Akorn, Inc. dated September 16, 2004, incorporated by reference
to Exhibit 3.1 to Akorn, Inc.s Registration Statement on Form S-1 filed on September 21, 2004. |
|
|
|
3.2
|
|
Amended and Restated By-laws of Akorn, Inc., incorporated by reference to Exhibit 3.2 to Akorn, Inc.s
Registration Statement on Form S-1 filed on June 14, 2005. |
|
|
|
3.3
|
|
Amendment to Bylaws of Akorn, Inc., incorporated by reference to Exhibit 3.1 to Akorn, Inc.s report
on Form 8-K filed on March 31, 2006. |
|
|
|
3.4
|
|
Amendment to Bylaws of Akorn, Inc., incorporated by reference to Exhibit 3.1 to Akorn, Inc.s report
on Form 8-K filed on December 14, 2006. |
|
|
|
4.1
|
|
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. |
|
|
|
4.2
|
|
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. |
|
|
|
4.3
|
|
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. |
|
|
|
4.4
|
|
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. |
|
|
|
4.5
|
|
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. |
|
|
|
4.6
|
|
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. |
|
|
|
4.7
|
|
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. |
|
|
|
4.8
|
|
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. |
61
|
|
|
Exhibit No. |
|
Description |
4.9
|
|
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. |
|
|
|
4.10
|
|
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. |
|
|
|
4.11
|
|
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. |
|
|
|
4.12
|
|
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. |
|
|
|
4.13
|
|
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. |
|
|
|
4.14
|
|
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. |
|
|
|
4.15
|
|
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. |
|
|
|
4.16
|
|
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.) |
|
|
|
4.17
|
|
Securities Purchase Agreement dated September 13, 2006, between Akorn, Inc. and Serum Institute of
India, incorporated by reference to Exhibit 4.1 to Akorn Inc.s report on Form 8-K filed September 14,
2006. |
|
|
|
10.1
|
|
Amended and Restated Akorn, Inc. 1988 Incentive Compensation Program, incorporated by reference to
Exhibit 10.2 to Akorn, Inc.s Registration Statement on Form S-1 filed on September 21, 2004. |
|
|
|
10.2
|
|
1991 Akorn, Inc. Stock Option Plan for Directors, incorporated by reference to Exhibit 10.3 to Akorn,
Inc.s Registration Statement on Form S-1 filed on September 21, 2004. |
|
|
|
10.3
|
|
Letter of Commitment to Akorn, Inc. from John. N. Kapoor dated April 17, 2001, incorporated by
reference to Exhibit 10.4 to Akorn, Inc.s report on Form 8-K filed on April 25, 2001 (Commission file
No. 000-13976). |
|
|
|
10.4
|
|
Convertible Bridge Loan and Warrant Agreement dated as of July 12, 2001, by and between Akorn, Inc.
and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit 10.1 to Akorn, Inc.s
report on Form 8-K filed on July 26, 2001 (Commission file No. 000-13976). |
|
|
|
10.5
|
|
The Tranche A Common Stock Purchase Warrant, dated July 12, 2001, incorporated by reference to Exhibit
10.2 to Akorn, Inc.s report on Form 8-K filed on July 26, 2001 (Commission file No. 000-13976). |
|
|
|
10.6
|
|
The Tranche B Common Stock Purchase Warrant, dated July 12, 2001, incorporated by reference to Exhibit
10.3 to Akorn, Inc.s report on Form 8-K filed on July 26, 2001 (Commission file No. 000-13976). |
62
|
|
|
Exhibit No. |
|
Description |
10.7
|
|
Registration Rights Agreement dated July 12, 2001, by and between Akorn, Inc. and The John N. Kapoor
Trust dated 9/20/89, incorporated by reference to Exhibit 10.4 to Akorn, Inc.s report on Form 8-K
filed on July 26, 2001 (Commission file No. 000-13976). |
|
|
|
10.8
|
|
Allonge to Revolving Note ($2 million) dated December 20, 2001 by and between Akorn, Inc. and The John
N. Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit 10.14 to Akorn, Inc.s
Registration Statement on Form S-1 filed on September 21, 2004. |
|
|
|
10.9
|
|
Allonge to Revolving Note ($3 million) dated December 20, 2001 by and between Akorn, Inc. and The John
N. Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit 10.15 to Akorn, Inc.s
Registration Statement on Form S-1 filed on September 21, 2004. |
63
|
|
|
Exhibit No. |
|
Description |
10.10
|
|
First Amendment to Convertible Bridge Loan and Warrant Agreement dated December 20, 2001 by and
between Akorn, Inc. and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit
10.16 to Akorn, Inc.s Registration Statement on Form S-1 filed on September 21, 2004. |
|
|
|
10.11
|
|
Supply Agreement dated January 4, 2002, by and between Akorn, Inc. and Novadaq Technologies, Inc.,
incorporated by reference to Exhibit 10.22 to Akorn, Inc.s report on Form 10-K for fiscal year ended
December 31, 2001 filed on April 16, 2002. |
|
|
|
10.12
|
|
Mutual Termination and Settlement Agreements by and between Akorn, Inc. and The Johns Hopkins
University/Applied Physics Laboratory dated. July 3, 2002, incorporated by reference to Exhibit 10.23
to Akorn, Inc.s report on Form 10-K for fiscal year ended December 31, 2001 filed on October 7, 2002. |
|
|
|
10.13
|
|
Second Amendment to Convertible Bridge Loan and Warrant Agreement dated August 31, 2002 by and between
Akorn, Inc. and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit 10.19 to
Akorn, Inc.s Registration Statement on Form S-1 filed on September 21, 2004. |
|
|
|
10.14
|
|
Amendment to Engagement Letter by and among Akorn, Inc. and AEG Partners LLC dated as of November 21,
2002 incorporated by reference to Exhibit 10.40 to Akorn, Inc.s report on Form 10-K for the fiscal
year ended December 31, 2002, filed on May 21, 2003. |
|
|
|
10.15
|
|
Third Amendment to Convertible Bridge Loan and Warrant Agreement dated December 31, 2002 by and
between Akorn, Inc. and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit
10.22 to Akorn, Inc.s Registration Statement on Form S-1 filed on September 21, 2004. |
|
|
|
10.16
|
|
Offer Letter dated January 22, 2003 from Akorn, Inc. to Arthur S. Przybyl, incorporated by reference
to Exhibit 10.41 to Akorn, Inc.s report on Form 10-K for the fiscal year ended December 31, 2003,
filed on May 21, 2003. |
|
|
|
10.17
|
|
Indemnification Agreement dated May 15, 2003 by and between Akorn, Inc. and Arthur S. Przybyl,
incorporated by reference to Exhibit 10.42 to Akorn, Inc.s report on Form 10-K for the fiscal year
ended December 31, 2002, filed on May 21, 2003. |
|
|
|
10.18
|
|
Credit Agreement dated October 7, 2003 among Akorn, Inc., Akorn New Jersey, Inc., the lenders party
thereto and LaSalle Bank National Association, as Administrative Agent, incorporated by reference to
Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed on October 24, 2003. |
|
|
|
10.19
|
|
Form of Indemnity Agreement dated October 7, 2003 between Akorn, Inc. and each of its directors,
incorporated by reference to Exhibit 10.1 to Akorn, Inc.s report on Form 10-Q for quarter ended
September 30, 2003, filed on November 19, 2003. |
|
|
|
10.20
|
|
Form of Subordination and Intercreditor Agreement dated October 7, 2003 among Akorn, Inc., Akorn (New
Jersey), Inc., LaSalle Bank and NeoPharm, incorporated by reference to Exhibit 10.4 to Akorn, Inc.s
report on Form 10-Q for quarter ended September 30, 2003, filed on November 19, 2003. |
|
|
|
10.21
|
|
Form of Fourth Amendment to Convertible Bridge Loan and Warrant Agreement dated October 7, 2003
between Akorn, Inc. and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit
10.5 to Akorn, Inc.s report on Form 10-Q for quarter ended September 30, 2003, filed on November 19,
2003. |
|
|
|
10.22
|
|
Limited Waiver Letter dated October 7, 2003 from The John N. Kapoor Trust dated 9/20/89, incorporated
by reference to Exhibit 10.34 to Akorn, Inc.s Registration Statement on Form S-1 filed on September
21, 2004. |
|
|
|
10.23
|
|
Form of Acknowledgment of Subordination dated October 7, 2003 between Akorn, Inc. and The John N.
Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit 10.6 to Akorn, Inc.s report on Form
10-Q for quarter ended September 30, 2003, filed on November 19, 2003. |
64
|
|
|
Exhibit No. |
|
Description |
10.24
|
|
Form of Subordination and Intercreditor Agreement dated October 7, 2003 among Akorn, Inc., Akorn (New
Jersey), Inc., LaSalle Bank and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to
Exhibit 10.7 to Akorn, Inc.s report on Form 10-Q for quarter ended September 30, 2003, filed on
November 19, 2003. |
|
|
|
10.25
|
|
Form of Subordination and Intercreditor Agreement dated October 7, 2003 among Akorn, Inc., Akorn (New
Jersey), Inc., LaSalle Bank and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to
Exhibit 10.8 to Akorn, Inc.s report on Form 10-Q for quarter ended September 30, 2003, filed on
November 19, 2003. |
|
|
|
10.26
|
|
Form of Subordination and Intercreditor Agreement dated October 7, 2003 among Akorn, Inc., Akorn (New
Jersey), Inc., LaSalle Bank and Arjun C. Waney, incorporated by reference to Exhibit 10.9 to Akorn,
Inc.s report on Form 10-Q for quarter ended September 30, 2003, filed on November 19, 2003. |
|
|
|
10.27
|
|
Form of Subordination and Intercreditor Agreement dated October 7, 2003 among Akorn, Inc., Akorn (New
Jersey), Inc., LaSalle Bank and Argent Fund Management Ltd, incorporated by reference to Exhibit 10.10
to Akorn, Inc.s report on Form 10-Q for quarter ended September 30, 2003, filed on November 19, 2003. |
|
|
|
10.28
|
|
Akorn, Inc. 2003 Stock Option Plan, incorporated by reference to Exhibit 10.35 to Akorn, Inc.s report
on Form 10-K for the fiscal year ended December 31, 2003, filed on March 30, 2004. |
|
|
|
10.29
|
|
Form of Akorn, Inc. Non-Qualified Stock Option Agreement, incorporated by reference to Exhibit 10.36
to Akorn, Inc.s report on Form 10-K for the fiscal year ended December 31, 2003, filed on March 30,
2004. |
|
|
|
10.30
|
|
Form of Akorn, Inc. Incentive Stock Option Agreement, incorporated by reference to Exhibit 10.37 to
Akorn, Inc.s report on Form 10-K for the fiscal year ended December 31, 2003, filed on March 30,
2004. |
|
|
|
10.31
|
|
Offer letter dated June 1, 2004 from Akorn, Inc. to Jeffrey A. Whitnell, incorporated by reference to
Exhibit 10.42 to Akorn, Inc.s report on Form 10-K for the fiscal year ended December 31, 2004, filed
March 30, 2005. |
|
|
|
10.32
|
|
Engagement Letter dated August 5, 2004 between Leerink Swann & Company and Akorn, Inc., incorporated
by reference to Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed on August 24, 2004. |
|
|
|
10.33
|
|
Waiver and Consent dated August 23, 2004, among LaSalle Bank National Association, the financial
institutions party thereto, Akorn, Inc. and Akorn (New Jersey), Inc., incorporated by reference to
Exhibit 10.2 to Akorn, Inc.s report on Form 8-K filed on August 24, 2004. |
|
|
|
10.34
|
|
Consent and Agreement of Holders of Series A 6.0% Participating Convertible Preferred Stock of Akorn,
Inc. dated as of August 17, 2004, incorporated by reference to Exhibit 10.3 to Akorn, Inc.s report on
Form 8-K filed on August 24, 2004. |
|
|
|
10.35
|
|
The AEG Stock Purchase Warrant, dated August 31, 2004, incorporated by reference to Exhibit 4.1 to
Akorn, Inc.s report on Form 8-K filed on September 9, 2004. |
|
|
|
10.36
|
|
Limited Liability Company Agreement dated September 22, 2004 between Akorn, Inc. and Strides Arcolab
Limited, incorporated by reference to Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed on
September 27, 2004. |
|
|
|
10.37
|
|
OEM Agreement dated September 22, 2004 between Akorn-Strides, LLC and Strides, incorporated by
reference to Exhibit 10.2 to Akorn, Inc.s report on Form 8-K filed on September 27, 2004. |
|
|
|
10.38
|
|
Sales and Marketing Agreement dated September 22, 2004 between Akorn, Inc. and Akorn-Strides, LLC,
incorporated by reference to Exhibit 10.3 to Akorn, Inc.s report on Form 8-K filed on September 27,
2004. |
65
|
|
|
Exhibit No. |
|
Description |
10.39
|
|
Promissory Note dated September 22, 2004 executed by Akorn-Strides, LLC for the benefit of Akorn,
Inc., incorporated by reference to Exhibit 10.4 to Akorn, Inc.s report on Form 8-K filed on September
27, 2004. |
|
|
|
10.40
|
|
Capital Contribution Agreement dated September 22, 2004 executed by Strides Arcolab Limited for the
benefit of Akorn-Strides, LLC, incorporated by reference to Exhibit 10.5 to Akorn, Inc.s report on
Form 8-K filed on September 27, 2004. |
|
|
|
10.41
|
|
Waiver Letter dated September 28, 2004 from The John N. Kapoor Trust dated 9/20/89, incorporated by
reference to Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed on September 30, 2004. |
66
|
|
|
Exhibit No. |
|
Description |
10.42
|
|
First Amendment to Credit Agreement dated August 13, 2004 among Akorn, Inc., Akorn New Jersey, Inc.,
Dr. John N. Kapoor, The John N. Kapoor Trust dated 9/20/90, the lenders party thereto and LaSalle Bank
National Association, as Administrative Agent, incorporated by reference to Exhibit 10.1 to Akorn,
Inc.s Report on Form 10-Q for the period ended June 30, 2004, filed on August 13, 2004. |
|
|
|
10.43
|
|
Second Amendment to Credit Agreement dated August 26, 2004 among Akorn, Inc., Akorn New Jersey, Inc.,
Dr. John N. Kapoor, The John N. Kapoor Trust dated 9/20/90, the lenders party thereto and LaSalle Bank
National Association, as Administrative Agent, incorporated by reference to Exhibit 10.1 to Akorn,
Inc.s report on Form 8-K filed on August 31, 2004. |
|
|
|
10.44
|
|
Third Amendment to Credit Agreement dated October 8, 2004 among Akorn, Inc., Akorn New Jersey, Inc.,
the lenders party thereto and LaSalle Bank National Association, as Administrative Agent, incorporated
by reference to Exhibit 10.53 to Akorn, Inc.s Pre-effective Amendment to Registration Statement on
Form S-1 filed October 13, 2004. |
|
|
|
10.45
|
|
Waiver and Consent dated October 8, 2004, among LaSalle Bank National Association, the financial
institutions party thereto, Akorn, Inc. and Akorn (New Jersey), Inc., incorporated by reference to
Exhibit 10.54 to Akorn, Inc.s Pre-effective Amendment to Registration Statement on Form S-1 filed
October 13, 2004 |
|
|
|
10.46
|
|
License and Supply Agreement November, 11 2004, between Hameln Pharmaceuticals Gmbh and Akorn, Inc.
incorporated by reference to Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed on November 17,
2004. |
|
|
|
10.47
|
|
Offer letter dated November 15, 2004, from Akorn, Inc. to Jeffrey A. Whitnell, for position of Senior
Vice President incorporated by reference to Exhibit 10.58 to Akorn, Inc.s report on Form 10-K filed
on March 30, 2005. |
|
|
|
10.48
|
|
Amended and Restated Akorn, Inc. 2003 Stock Option Plan incorporated by reference to Exhibit 10.59 to
Akorn, Inc.s report on Form 10-K filed on March 30, 2005. |
|
|
|
10.49
|
|
Amended and Restated Employee Stock Purchase Plan incorporated by reference to Exhibit 10.58 to Akorn,
Inc.s Registration Statement on Form S-1 filed May 10, 2005. |
|
|
|
10.50
|
|
Waiver and Consent to Credit Agreement dated May 13, 2005 between Akorn, LaSalle Bank, the financial
institutions party thereto and Akorn (New Jersey), Inc. incorporated by reference to Exhibit 10.1 to
the Companys report on Form 8-K filed on May 19, 2005. |
|
|
|
10.51
|
|
Note Repayment Agreement dated May 16, 2005, by and between NeoPharm, Inc. and Akorn, Inc.
incorporated by reference to Exhibit 10.63 to Akorn, Inc.s Registration Statement on Form S-1 filed
on June 14, 2005. |
|
|
|
10.52
|
|
Fourth Amendment to the Credit Agreement among Akorn, Inc., LaSalle Bank, the financial institutions
party thereto and Akorn (New Jersey), Inc., incorporated by reference to Exhibit 10.1 to Akorn, Inc.s
report on Form 8-K filed on October 5, 2005. |
|
|
|
10.53
|
|
Master Letter of Credit Agreement among Akorn, Inc., LaSalle Bank, the financial institutions party
thereto and Akorn (New Jersey), Inc., incorporated by reference to Exhibit 10.2 to Akorn, Inc.s
report on Form 8-K filed on October 5, 2005. |
|
|
|
10.54
|
|
Solicitation/Contract/Order for Commercial Items issued by the HHS to Akorn, Inc. on December 30, 2005. |
|
|
|
10.55
|
|
Executive Bonus Agreement by and between Akorn, Inc. and Arthur S. Przybyl dated December 27, 2005
incorporated by reference to Exhibit 99.1 to the Companys report on Form 8-K filed January 3, 2006. |
|
|
|
10.56
|
|
Executive Bonus Agreement by and between Akorn, Inc. and Jeffrey A. Whitnell dated December 27, 2005
incorporated by reference to Exhibit 99.2 to the Companys report on Form 8-K filed January 3, 2006. |
67
|
|
|
Exhibit No. |
|
Description |
10.57
|
|
Amendment, Waiver and Consent to Credit Agreement dated March 1, 2006, among LaSalle Bank, the
Lenders, Akorn, Inc. and Akorn (New Jersey) incorporated by reference to Exhibit 10.1 to Akorn, Inc.s
report on Form 8-K filed March 7, 2006. |
|
|
|
10.58
|
|
Waiver and Consent to Credit Agreement dated March 20, 2006 among Akorn, Inc., LaSalle Bank, the
financial institutions party thereto and Akorn (New Jersey), Inc., incorporated by reference to
Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed March 24, 2006. |
|
|
|
10.59
|
|
Waiver and Consent to Credit Agreement dated March 31, 2006 among Akorn, Inc., LaSalle Bank, the
financial institutions party thereto and Akorn (New Jersey), Inc., incorporated by reference to
Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed March 31, 2006. |
|
|
|
10.60
|
|
Executive Employment Agreement dated April 24, 2006 between Akorn, Inc., and Arthur S. Przybyl
incorporated by reference to Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed April 28, 2006. |
|
|
|
10.61W
|
|
Executive Bonus Agreement dated April 27, 2006 between Akorn, Inc., and Arthur S. Przybyl incorporated
by reference to Exhibit 10.2 to Akorn, Inc.s report on Form 8-K filed April 28, 2006. |
|
|
|
10.62W
|
|
Executive Bonus Agreement dated April 27, 2006 between Akorn, Inc., and Jeffrey A. Whitnell
incorporated by reference to Exhibit 10.3 to Akorn, Inc.s report on Form 8-K filed April 28,
2006. |
|
|
|
10.63
|
|
Waiver and Consent to Credit Agreement dated September 13, 2006, among LaSalle Bank National
Association, the financial institutions party thereto, Akorn, Inc. and Akorn (New Jersey), Inc.
incorporated by reference to Exhibit 10.1 to Akorn Inc.s report on Form 8-K filed September 14, 2006. |
|
|
|
10.64
|
|
Akorn, Inc. Director Compensation Agreement dated October 26, 2006, incorporated by reference to
Exhibit 10.2 to Akorn, Inc.s report on Form 10-Q filed November 9, 2006. |
|
|
|
10.65W
|
|
Development and Exclusive Distribution Agreement dated November 7, 2006 between Akorn, Inc. and Serum
Institute of India, Ltd. incorporated by reference to Exhibit 10.1 to Akorn Inc.s report on Form 8-K
filed November 14, 2006. |
|
|
|
10.66W
|
|
Development Funding Agreement dated November 7, 2006 between Akorn, Inc. and Serum Institute of India,
Ltd. incorporated by reference to Exhibit 10.2 to Akorn Inc.s report on Form 8-K filed November 14,
2006. |
|
|
|
10.67
|
|
First Amendment to OEM Agreement dated December 8, 2004 between Akorn-Strides, LLC and Strides Arcolab
Limited incorporated by reference to Exhibit 10.2 to Akorn Inc.s report on Form 8-K filed December
12, 2006. |
|
|
|
10.68
|
|
Second Amendment to OEM Agreement dated December 31, 2004 between Akorn-Strides, LLC and Strides
Arcolab Limited incorporated by reference to Exhibit 10.3 to Akorn Inc.s report on Form 8-K filed
December 12, 2006. |
|
|
|
10.69W
|
|
Third Amendment to OEM Agreement dated October 26, 2005 between Akorn-Strides, LLC and Strides Arcolab
Limited incorporated by reference to Exhibit 10.4 to Akorn Inc.s report on Form 8-K filed December
12, 2006. |
|
|
|
10.70
|
|
Fourth Amendment to OEM Agreement dated February 1, 2006 between Akorn-Strides, LLC and Strides
Arcolab Limited incorporated by reference to Exhibit 10.5 to Akorn Inc.s report on Form 8-K filed
December 12, 2006. |
|
|
|
10.71W
|
|
Fifth Amendment to OEM Agreement dated November 28, 2006 between Akorn-Strides, LLC and Strides
Arcolab Limited incorporated by reference to Exhibit 10.1 to Akorn Inc.s report on Form 8-K filed
December 12, 2006. |
|
|
|
10.72
|
|
Office Lease dated December 21, 2006, between Akorn, Inc. and Duke Realty Limited Partnership
incorporated by reference to Exhibit 10.1 to Akorn Inc.s report on Form 8-K filed December 28, 2006. |
68
|
|
|
Exhibit No. |
|
Description |
10.73
|
|
Amendment to Credit Agreement dated March 5, 2007 between Akorn, Inc., LaSalle Bank, the financial
institutions party thereto and Akorn (New Jersey), Inc. incorporated by reference to Exhibit 10.1 to
Akorn Inc.s report on Form 8-K filed March 6, 2006. |
|
|
|
10.74*
|
|
Addendum 1 to License and Supply Agreement dated November, 11 2004, between Hameln Pharmaceuticals
Gmbh and Akorn, Inc. |
|
|
|
10.75*
|
|
Guaranty and Collateral Agreement dated October 7, 2003, between Akorn, Inc., LaSalle Bank, the
grantors party thereto and Akorn (New Jersey), Inc. |
|
|
|
21.1
|
|
Subsidiaries of Akorn, Inc., incorporated by reference to Exhibit 21.1 to Akorn, Inc.s Pre-effective
Amendment to Registration Statement on Form S-1 filed October 13, 2004. |
|
|
|
23.1*
|
|
Consent of Registered Public Accountant |
|
|
|
31.1*
|
|
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2*
|
|
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1*
|
|
Certification of the Chief Executive Officer pursuant to 18 USC Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2*
|
|
Certification of the Chief Financial Officer pursuant to 18 USC Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
(b)
|
|
See (a)3 above. |
|
|
|
(c)
|
|
See (a)1 above. |
69
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
AKORN, INC.
|
|
|
By: |
/s/ ARTHUR S. PRZYBYL
|
|
|
|
Arthur S. Przybyl |
|
|
|
Chief Executive Officer |
|
|
Date: March 14, 2007
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the Registrant, and in the capacities and on the
dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
/s/ ARTHUR S. PRZYBYL
Arthur S. Przybyl |
|
Chief Executive Officer
(Principal Executive Officer)
|
|
March 14, 2007 |
/s/ JEFFREY A. WHITNELL
Jeffrey A. Whitnell |
|
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
|
|
March 14, 2007 |
/s/ DR. JOHN KAPOOR
Dr. John Kapoor |
|
Director, Board Chairman
|
|
March 14, 2007 |
/s/ JERRY N. ELLIS
Jerry N. Ellis |
|
Director
|
|
March 14, 2007 |
/s/ JERRY TREPPEL
Jerry Treppel |
|
Director
|
|
March 14, 2007 |
/s/ RONALD M. JOHNSON
Ronald M. Johnson |
|
Director
|
|
March 14, 2007 |
70