424B3
Filed
pursuant to Rule 424(b)(3)
Registration Statement No. 333-160077
PROSPECTUS
1,888,530 Shares
Akorn, Inc.
Common Stock
This prospectus relates to the resale of 1,888,530 shares of our common stock by the selling
security holders identified in this prospectus in the section below entitled SELLING SECURITY
HOLDERS. Those shares are owned by the selling security holders or reserved for issuance upon the
exercise of outstanding warrants. The selling security holders may sell those shares in public or
private transactions, at prevailing market prices, or at privately negotiated prices. They may
sell the shares directly to purchasers or through brokers or dealers. Brokers or dealers may
receive compensation in the form of discounts, concessions or commissions from the selling security
holders. We will not receive any of the proceeds from the sale of the shares by the selling
security holders. The selling security holders will receive all the proceeds and will pay all
underwriting discounts and selling commissions, if any, applicable to the sale of the shares. We
(Akorn, Inc.) will, in the ordinary course of business, receive proceeds from the issuance of
shares upon exercise of the warrants described in this prospectus, unless such warrants are
exercised on a cashless basis. We will pay the expenses of registration of the sale of the shares.
It is not possible at the present time to determine the price to the public in any sale of the
shares by the selling security holder, and each selling security holder reserves the right to
accept or reject, in whole or in part, any proposed purchase of shares. Accordingly, the public
offering price, the amount of any applicable underwriting discounts and commissions and the net
proceeds to the selling security holders will be determined at the time of each such sale by a
selling security holder. The resale of the shares of our common stock described in this prospectus
was originally registered on our registration statement on Form S-3, Registration No. 333-133307,
filed with the SEC on April 14, 2006, effective on April 28, 2006.
Our common stock is traded on the Nasdaq Global Market under the symbol AKRX. On June 11,
2009, the last reported sales price of our common stock was $0.99 per share.
Our principal executive offices are located at 1925 W. Field Court, Suite 300, Lake Forest,
Illinois 60045. Our telephone number is (847) 279-6100.
Investing in our common stock involves risks.
See Risk Factors beginning on page 3.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is July 15, 2009
TABLE OF CONTENTS
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(i)
ABOUT THIS PROSPECTUS
You should rely only on the information contained or incorporated by reference in this
prospectus and any applicable prospectus supplements. We have not authorized anyone to provide you
with different information. The selling security holders are not offering to sell or seeking
offers to buy shares of our common stock in jurisdictions where offers and sales are prohibited.
The information contained in this prospectus is accurate only as of the date of this prospectus,
regardless of the time of delivery of this prospectus or of any sale of our common stock.
References in this prospectus to Akorn, us, we, our, or the Company refer to Akorn,
Inc. and its subsidiary, Akorn (New Jersey), Inc., as the context requires. The phrase this
prospectus refers to this prospectus and any applicable prospectus supplement and the documents
incorporated by reference in this prospectus, unless the context otherwise requires.
FORWARD-LOOKING STATEMENTS AND FACTORS AFFECTING FUTURE RESULTS
Certain statements in this prospectus constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act. When used in this prospectus, the words
anticipate, believe, could, should, propose, continue, estimate, expect, intend,
may, plan, predict, project, will and similar expressions are generally intended to
identify forward-looking statements. Any forward-looking statements, including statements
regarding our intent, belief or expectations are not guarantees of future performance. These
statements involve risks and uncertainties, and actual results may differ materially from those in
the forward-looking statements as a result of various factors, including but not limited to:
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The factors described in this prospectus under the heading Risk Factors beginning
on page 3; |
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Our ability to continue to comply with all of the requirements of the U.S. Food and
Drug Administration (FDA), including current Good Manufacturing Practices (cGMP)
regulations; |
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Our ability to obtain regulatory approvals for products manufactured in our new
lyophilization facility; |
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Our ability to avoid defaults under debt covenants; |
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Our ability to generate cash from operations sufficient to meet our working capital
requirements; |
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Our ability to obtain additional funding or financing to operate and grow our
business; |
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The effects of federal, state and other governmental regulation on our business; |
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Our success in developing, manufacturing, acquiring and marketing new products; |
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Our success in gaining additional market share for our Tetanus-Diphtheria (Td)
vaccine purchased by hospitals and physicians through our key wholesalers, distributors
and direct sales channels; |
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Our ability to make timely payments to our Td vaccine supplier; |
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The success of our strategic partnerships for the development and marketing of new
products; |
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Our ability to bring new products to market and the effects of sales of such products
on our financial results; |
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The effects of competition from generic pharmaceuticals and from other pharmaceutical
companies; |
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Our ability to successfully transition to a new senior management team and to find a
non-interim CEO; |
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Availability of raw materials needed to produce our products; and |
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Other factors referred to in this prospectus and our other Securities and Exchange
Commission (SEC) filings. |
You should read this prospectus completely with the understanding that our actual results may
differ materially from what we expect. Unless required by law, we undertake no obligation to
update publicly any forward-looking statements, whether as a result of new information, future
events or otherwise.
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SUMMARY
This summary does not contain all of the information you should consider before buying shares
in this offering. You should read this entire prospectus carefully, including Risk Factors, any
prospectus supplement and the documents incorporated by reference in this prospectus before making
an investment decision.
Company Overview
We manufacture and market diagnostic and therapeutic pharmaceuticals in specialty areas such
as ophthalmology, rheumatology, anesthesia and antidotes, among others. In addition, we market and
distribute vaccines purchased from outside sources. 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 four identifiable business segments,
ophthalmic, hospital drugs & injectables, biologics & vaccines and contract services. These four
segments are described in greater detail below.
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.
Biologics & Vaccines Segment. We market adult Td vaccines. We also expanded into flu vaccine
in 2008. We expect to add other vaccines produced by third party biologics manufacturers in the
future. These vaccines are marketed directly to hospitals and physicians as well as through
wholesalers and national distributors.
Contract Services Segment. We manufacture products for third party pharmaceutical and
biotechnology customers based on their specifications.
Offering Overview
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Issuer
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Akorn, Inc. |
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Address and Phone Number
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1925 W. Field Court, Suite 300, Lake Forest, Illinois 60045 (847) 279-6100 |
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Nasdaq Global Market Trading Symbol
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AKRX |
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Website
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www.akorn.com (information found on our website is not part of this prospectus) |
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Securities Offered
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Up to 1,888,530 (1) shares of our common stock, no par value by the
selling security holders. |
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Use of Proceeds
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We will not receive any proceeds from the sale of shares of our common stock
covered by this prospectus. We will receive proceeds from the exercise of the
warrants described in this prospectus except in the case of any cashless
exercise. |
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Risk Factors
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In analyzing an investment in our common stock offered by this prospectus, you
should carefully consider the information set forth under Risk Factors. |
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(1) |
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Includes 999,641 shares of common stock issuable upon exercise of outstanding warrants. The
number of shares of common stock is subject to adjustment to prevent dilution resulting from stock
splits, stock dividends or similar events. Therefore, pursuant to Rule 416, we are also
registering such indeterminate number of shares as may be issuable in connection with such events.
The holders of the securities registered hereunder have direct registration rights for this
offering. |
We have reserved for issuance the shares of our common stock identified in this prospectus. Each
of the above securities being offered by the selling security holders were restricted securities
under the Securities Act of 1933, (Securities Act,) prior to this registration and the
registration on our registration statement on Form S-3, Registration No. 333-133307, filed with the
SEC on April 14, 2006. The selling security holders will determine if and when it will sell their
shares and if they will sell their shares at the current market price or at prices negotiated at
the time of the sale.
2
RISK FACTORS
You should carefully consider the following risk factors and all other information contained in
this prospectus and the documents incorporated by reference in this prospectus before investing.
Investing in our common stock involves a high degree of risk. The risks and uncertainties
described below are not the only ones we face. Additional risks and uncertainties not presently
known to us or that we currently believe are immaterial also may impair our business. If any of
the events described in the following risks occur, our business, results of operations and
financial condition could be materially adversely affected. In addition, the trading price of our
common stock could decline, or in all events not rise, due to any of the events described in these
risks, and you may lose all or part of your investment.
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, 2008, 2007 and 2006, our operating
losses were $7,183,000, $19,815,000 and $4,905,000, respectively. We generated a positive cash flow
from operations in 2006 of $2,509,000, however, we generated negative cash flows of $5,420,000 and
$24,891,000 in 2008 and 2007, respectively. If our results of operations do not improve we would
have to implement a restructuring plan in order to preserve our cash flow and continue business
operations.
There is substantial doubt as to our ability to continue as a going concern.
As a result of our lack of liquidity, limited capital resources, continued losses and
accumulated debt, we have concluded that there is substantial doubt as to our ability to continue
as a going concern, and our independent registered public accounting firm has included in their
report on our 2008 consolidated financial statements which is included in our annual report on Form
10-K filed with the SEC on March 30, 2009, an explanatory paragraph describing certain conditions
that have given rise to this uncertainty. These factors may make it more difficult for us to obtain
additional funding to meet our obligations. Our ability to continue as a going concern is dependent
upon our ability to generate or obtain sufficient cash to meet our obligations on a timely basis.
Our losses from 2001 until December 31, 2008, have totaled $85,128,000. Based on our operating
plan, our existing working capital is not sufficient to meet the cash requirements to fund our
planned operating expenses, capital expenditures, and working capital requirements through December
31, 2009 without additional sources of cash or the deferral, reduction or elimination of
significant planned expenditures. Currently, we have no commitments to obtain additional capital,
and there can be no assurance that financing will be available in amounts or on terms acceptable to
us, if at all. See also Risks relating to our Credit Agreement and Inadequate liquidity could
materially adversely affect our business operations in the future.
Risks relating to our Credit Agreement
Our lender has restricted our ability to draw on our Credit Agreement. We are party to a
Credit Agreement (Credit Agreement), initially with General Electric Capital Corporation as agent
for the lenders from time to time party to the Credit Agreement and for itself as a lender, which
was assigned to EJ Funds LP (EJ Funds) on March 31, 2009, and modified by the Modification,
Warrant and Investor Rights Agreement dated April 13, 2009, between us and EJ Funds (Modification
Agreement). Pursuant to the Credit Agreement as modified by the Modification Agreement, among
other things, EJ Funds agreed to extend loans to us under a revolving credit facility of up to
$5,650,000.
The limitation on our ability to borrow under the Credit Agreement could have important
adverse consequences on our future operations, including: making it more difficult for us to meet
our payment and other obligations; reducing the availability of our cash flow to fund working
capital, capital expenditures, acquisitions and other general corporate purposes, and limiting our
ability to obtain additional financing for these purposes; limiting our flexibility in planning
for, or reacting to, and increasing our vulnerability to, changes in our business, the industries
in which we operate and the general economy; and placing us at a competitive disadvantage compared
to our competitors that have fewer restrictions on borrowing or greater access to capital. If we
are unable to convince EJ Funds to remove the restriction on our ability to borrow under the Credit
Agreement or obtain otherwise suitable financing, we may not be able to meet our payment and other
obligations which could significantly and materially harm our business and we may not be able to
continue as a going concern. There is no guarantee that we will be successful in convincing EJ
Funds to increase our ability to borrow or that we will be able to obtain otherwise suitable
financing.
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Our ability to continue as a going concern depends on our compliance with the terms of our
Credit Agreement and Modification Agreement, and on the availability of additional financing. Our
Credit Agreement and the Modification Agreement contain a number of agreements and covenants that
we may not be able to comply with. Should a default be declared, we might have to repay any money
borrowed thereunder. This would threaten our ability to continue as a going concern. Alternative
financing could replace our relationship with EJ Funds, but if we are forced to seek that
financing, we do not believe it would be on favorable terms and there can be no assurance as to the
amount of any financing that might be available.
Inadequate liquidity could materially adversely affect our business operations.
We require substantial liquidity to implement long-term cost savings and restructuring plans,
continue capital spending to support product programs and development of advanced technologies,
meet scheduled term debt and lease maturities, and run our normal business operations. If we
continue to operate at or below the minimum cash levels necessary to support our normal business
operations, we may be forced to further curtail capital spending, research and development and
other programs that are important to the future success of our business. As discussed above, EJ
Funds has responded to the weakening of our liquidity position by limiting our ability to borrow
under the Credit Agreement. It is likely that, if we were to lose our ability to access amounts
under the Credit Agreement, we would be unable to find additional capital or alternative financing
necessary to sustain our current business operations. If we fail to obtain sufficient funding for
any reason, we would not be able to continue as a going concern.
Our lack of liquidity has caused us to be unable to make payments when due under our Exclusive
Distribution Agreement with Massachusetts Biologic Laboratories.
Due to our limited liquidity, we were unable to make a payment of approximately $3,375,000 for
Td vaccine products which was due to our strategic partner, Massachusetts Biologic Laboratories of
the University of Massachusetts (MBL), by February 27, 2009 under our modified Exclusive
Distribution Agreement with MBL dated March 22, 2007 (the MBL Distribution Agreement). While we
made a partial payment of $1,000,000 to MBL on March 13, 2009, we were also unable to make another
payment of approximately $3,375,000 due to MBL on March 28, 2009. Accordingly, we entered into a
letter agreement with MBL on March 27, 2009 (the MBL Letter Agreement), pursuant to which we
agreed to pay MBL the $5,750,000 remaining due for these Td vaccine products plus an additional
$4,750,000 in consideration of the amendments to the MBL Distribution Agreement payable according
to a periodic payment schedule through June 30, 2010. In addition, pursuant to the MBL Letter
Agreement, the MBL Distribution Agreement was converted to a non-exclusive agreement. Dr. John
Kapoor, the Chairman of our board of directors and one of our principal shareholders, provided MBL
with a standby letter of credit to secure our obligation to pay amounts due to MBL, and we were
released from our obligation to purchase further Td vaccine products from MBL. In addition,
pursuant to the MBL Letter Agreement, MBL agreed not to declare a breach or otherwise act to
terminate the MBL Distribution Agreement, provided that we comply with the MBL Letter Agreement,
the MBL Distribution Agreement (as amended by the MBL Letter Agreement) and any agreements required
to be entered into pursuant to the MBL Letter Agreement.
On April 13, 2009, we paid MBL $1,000,000 of the past due amount and on April 15, 2009, we and
MBL entered into a Settlement Agreement (the Settlement Agreement) to elaborate the Letter
Agreement. The Settlement Agreement provides that we will pay MBL the $4,750,000 remaining due for
delivered Td vaccine products plus an additional $4,750,000 as consideration for amendments to the
MBL Distribution Agreement (the Settlement Payments) payable according to a monthly payment
schedule through June 30, 2010. The Settlement Agreement provides that MBL may only draw on the
standby letter of credit if: (i) we fail to make any Settlement Payment when due, (ii) any
Settlement Payment made is set aside or otherwise required to be repaid by MBL, or (iii) we become
the debtor in a bankruptcy or other insolvency proceeding begun before October 6, 2010 and no
replacement letter of credit has been issued prior to the expiration of the current letter of
credit. Also on April 15, 2009, we and MBL entered into an amendment to the MBL Distribution
Agreement (the Amendment). The Amendment modifies the MBL Distribution Agreement to, among other
things, eliminate our future minimum purchase requirements under the MBL Distribution Agreement.
If for any reason we are unable to make any payment under the MBL Letter Agreement or
Settlement Agreement when due and MBL is unable to draw on the standby letter of credit, we would
be in breach of the MBL Letter Agreement and/or Settlement Agreement which could significantly and
materially harm our business and cause us to not be able to continue as a going concern.
We must obtain additional capital to continue our operations.
We will require additional funds to operate and grow our business. We may seek additional
funds through public and private financing, including equity and debt offerings. However, adequate
funds through the financial markets or from other sources may not be available when needed or on
terms favorable to us. Without sufficient additional funding, we may be required to delay, scale
back
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or abandon some or all of our product development, manufacturing, acquisition, licensing and
marketing initiatives, or operations. Further, such additional financing, if obtained, likely will
require us to confer rights senior to those of the common stock and result in substantial dilution
of the existing ownership interests of the common shareholders, 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.
Unstable market and economic conditions may have serious adverse consequences on our business.
Our general business strategy may be adversely affected by the recent economic downturn and
volatile business environment and continued unpredictable and unstable market conditions. If the
current equity and credit markets deteriorate further, or do not improve, it may make any necessary
debt or equity financing more difficult, more costly, and more dilutive. A prolonged or profound
economic downturn may result in adverse changes to product reimbursement, pricing or sales levels,
which would harm our operating results. There is a risk that one or more of our current service
providers, manufacturers and other partners may not survive these difficult economic times, which
would directly affect our ability to attain our operating goals on schedule and on budget. Failure
to secure any necessary financing in a timely manner and on favorable terms could have a material
adverse effect on our growth strategy, financial performance and stock price and could require us
to delay or abandon development plans. There is also a possibility that our stock price may decline
further, due in part to the volatility of the stock market and the general economic downturn.
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 have completed the final stages of an expansion of our Decatur, Illinois manufacturing
facility to add capacity to provide lyophilization manufacturing services, a manufacturing
capability we previously did not have. We spent $22,680,000 on the lyophilization facility
expansion, which is now complete. In December 2006, we placed the sterile solutions portion of
this operation in service which augments our existing production capacities. In December 2008 our
lyophilization (freeze-dry) operations were validated and placed in service.
We are producing our lyophilized IC Green product on this equipment and are working to
internally develop an abbreviated new drug application (ANDA) lyophilized products pipeline.
However, there is no guarantee that we will be successful in attaining additional lyophilization
customers or products, or that intervening events will not occur that reduce or eliminate the
additional 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. There can be no assurance that we will realize all the anticipated
benefits from this significant investment, 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 wholesalers, AmerisourceBergen
Corporation, Cardinal Health, Inc. and McKesson Drug Company, accounted for approximately 67% of
total gross sales and 57% of total revenues for the three months ended March 31, 2009, and 65% of
gross trade receivables as of March 31, 2009. 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 wholesalers, 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.
Our growth depends on our ability to timely develop additional pharmaceutical products and
manufacturing capabilities.
Our strategy for growth is dependent on 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 new drug applications (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,
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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 or additional costs, 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. Our joint
venture has generated several product introductions, however, there can be no assurance that these
agreements will result in additional FDA-approved ANDAs or NDAs, or that we will be able to market
any such additional products at a profit. In addition, any clinical trial expenses that we incur
may result in adverse financial consequences to our business.
Our growth and profitability is dependent on our ability to successfully market and distribute
new products, including vaccine products, through various distribution channels.
We continue to seek out and introduce new pharmaceutical/healthcare products. Our improved
financial performance is dependent on new product introductions, such as the biologics and vaccine
products discussed above. Any delays or an inability to successfully market and distribute such
products may result in adverse financial consequences to our business. In particular, continued
growth for our Td vaccine product is dependent on successful management of market penetration on
hospital group purchasing organization contracts.
We have accumulated substantial Td vaccine inventory which may be difficult to sell.
We have accumulated substantial Td vaccine inventory quantities which will require time to
sell and may require discounting to generate cash flow to fund operations for the company. In
addition, we have lost our exclusive distribution rights for this Td vaccine product as per the MBL
Letter Agreement dated March 27, 2009. While we anticipate selling at prices in excess of our
carrying value, extensive discounting to generate cash for our operations and/or discounting to
respond to competitor pricing could be required and, if so, this would adversely impact our profit
margins which could impact our ability to continue as a going concern.
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 uncompetitive or obsolete. There can be no
assurance that we will be able to consistently bring generic pharmaceutical products to market
quickly and efficiently in the future. An increase in competition in the sale of generic
pharmaceutical products or our failure to bring such products to market before our competitors
could have a material adverse effect on our business, financial condition and results of
operations.
Further, there is no proprietary protection for most of the branded pharmaceutical products
that either we or other pharmaceutical companies sell. In addition, governmental and
cost-containment pressures regarding the dispensing of generic equivalents will likely result in
generic substitution and competition generally for our branded pharmaceutical products. We attempt
to mitigate the effect of this substitution through, among other things, creation of strong
brand-name recognition and product-line extensions for our branded pharmaceutical products, but
there can be no assurance that we will be successful in these efforts.
We can be subject to legal proceedings against us, which may prove costly and time-consuming
even if meritless.
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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 our personnel spend time and other resources
to pursue or contest any matters that may be asserted from time to time in the future, this
represents time and money not available for other actions we might otherwise pursue which could be
beneficial to our future. In addition, to the extent that we are unsuccessful in any legal
proceedings, the consequences could have a negative impact on our business, financial condition and
results of operations.
Our revenues depend on sale of products manufactured by third parties, which we cannot
control.
We derive a significant portion of our revenues from the sale of products manufactured by
third parties, 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.
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 which is the
general partner of EJ Funds. 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. The Kapoor Trust is also one of our lenders through a
subordinated promissory note and EJ Funds is one of our lenders through the Credit Agreement.
Potential conflicts of interest could have a material adverse effect on our business, financial
condition and results of operations.
Dr. Subhash Kapre is a member of our board of directors and is the Executive Director of Serum
Institute of India, Ltd. (Serum). We are a party to several product development agreements with
Serum and additional future agreements or changes to existing agreements have the potential to
create a conflict of interest for Dr. Kapre.
Through stock ownership, his position on our board of directors, and his loans to us, Dr. John
Kapoor has substantial influence over our business strategies and policies.
Dr. John Kapoor owns, directly and indirectly, a substantial portion of our outstanding voting
common stock. Dr. Kapoor is also Chairman of our board of directors. Further, Dr. Kapoor is a
substantial creditor of ours. Because of this, Dr. Kapoor can strongly influence, and potentially
control, the outcome of our corporate actions, including the election of our directors and
transactions involving a change of control. Decisions made by Dr. Kapoor with respect to his, and
his related parties, ownership or trading of our common stock, or with regards to our outstanding
debt, could have an adverse effect on the market value of our common stock and an adverse effect on
our business.
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.
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.
Recent changes in our senior management may cause uncertainty in, or be disruptive to, our
business.
We have recently experienced significant changes in our senior management and our board of
directors. On January 29, 2009 Arthur Przybyl was given notice of his termination as President and
Chief Executive Officer. On the same day, the board of directors
7
formed a committee to oversee our operations until a new President and Chief Executive Officer
is appointed and begins service in those positions. The committee is comprised of Dr. John Kapoor,
Chairman of the board of directors, and Randall Wall and Jerry Ellis, both members of the board of
directors. On March 29, 2009, our board of directors appointed Jeffrey A. Whitnell, our then
current Sr. Vice President, Chief Financial Officer, Secretary and Treasurer, as our interim Chief
Executive Officer. On June 9, 2009, our board of directors announced Mr. Whitnells departure and
the appointments of Raj Rai as our interim Chief Executive Officer, Timothy A. Dick as our Chief
Financial Officer and Joseph Bonaccorsi as Senior Vice President, General Counsel and Secretary.
These changes in our senior management may be disruptive to our business, and, during the
transition period, there may be uncertainty among investors, vendors, employees and others
concerning our future direction and performance.
We must continue to attract and retain key personnel to be able to compete successfully.
Our performance depends, to a large extent, on the continued service of our key research and
development personnel, other technical employees, managers and sales personnel and our ability to
continue to attract and retain such personnel. Competition for such personnel is intense,
particularly for highly motivated and experienced research and development and other technical
personnel. We are facing increasing competition from companies with greater financial resources for
such personnel. There can be no assurance that we will be able to attract and retain sufficient
numbers of highly skilled personnel in the future, and the inability to do so could have a material
adverse effect on our business, operating results and financial condition and results of
operations.
We are subject to extensive government regulations that increase our costs and could subject
us to fines, prevent us from selling our products or prevent us from operating our facilities.
Federal and state government agencies regulate virtually all aspects of our business. The
development, testing, manufacturing, processing, quality, safety, efficacy, packaging, labeling,
record keeping, distribution, storage and advertising of our products, and disposal of waste
products arising from such activities, are subject to regulation by the FDA, Drug Enforcement
Administration (DEA), Federal Trade Commission, 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.
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 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.
8
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. In March 2007, we were again subject to a warning letter at
our Decatur facility which was removed in December 2007.
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 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 non-application drugs that are manufactured and marketed
without FDA-issued ANDAs or NDAs on the basis of their having been marketed prior to the 1962
Amendment of the FDC Act. The regulatory status of these products is subject to change and/or
challenge by the FDA, which could establish new standards and limitations for manufacturing and
marketing such products, or challenge the evidence of prior manufacturing and marketing upon which
grandfathering status is based. Any such change in the status of such 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,
licensing, security and record keeping requirements administered by the DEA and similar state
agencies, as well as quotas for the manufacture, purchase and sale of controlled substances. The
DEA could limit or reduce the amount of controlled substances which we are permitted to manufacture
and market.
We may implement product recalls and could be exposed to significant product liability claims;
we may have to pay significant amounts to those harmed and may suffer from adverse publicity as a
result.
The manufacturing and marketing of pharmaceuticals involves an inherent risk that our products
may prove to be defective and cause a health risk. In that event, we may voluntarily implement a
recall or market withdrawal or may be required to do so by a regulatory authority. We have recalled
products in the past and, based on this experience, believe that the occurrence of a recall could
result in significant costs to us, potential disruptions in the supply of our products to our
customers and adverse publicity, all of which could harm our ability to market our products. We
were prompted to initiate one product recall of our Cyanide Antidote Kit during 2008, due to the
third quarter recall notification by Becton, Dickinson and Company (BD), of its 60ml syringe.
This syringe is included as part of a packaged kit along with drug components manufactured and
sourced by us, to support the Cyanide Antidote Kit. Our recall of the Cyanide Antidote Kit was
necessitated by the BD recall, but has resulted in no patient impact and no shortage of product
supply to the marketplace. Our supporting efforts were reviewed by the FDA, as part of our due
diligence in apprising the agency of our reaction to the BD recall. We had no product recalls in
2007 or 2006.
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
9
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 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 declines in our share price.
10
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 many of our outstanding shares and shares issuable upon the exercise of convertible
securities for sale under registration statements filed with the SEC and some of our outstanding
shares not currently registered for sale can nevertheless be sold under exemptions from the SECs
registration requirements. 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
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 9,228,951 shares of
our common stock, absent any cashless exercise, at a weighted average exercise price of $3.49 per
share. Any additional financing that we secure likely will require that we grant rights senior to
those of our common stock which may result in substantial dilution of the existing ownership
interests of our common shareholders.
We may issue preferred stock and the terms of such 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, of which 4,572,828 shares have never been designated or issued. Our board of directors may
determine whether to issue shares of 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 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 the date of this Prospectus, the market price of our common stock does not exceed $5.00
per share. Because our market price has fallen 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 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.
Changes in accounting standards issued by the Financial Accounting Standards Board or other
standard setting bodies may adversely affect our reported revenues, profitability, and financial
condition.
11
Our financial statements are subject to the application of U.S. generally accepted accounting
principles, which are periodically revised or expanded. The application of accounting principles is
also subject to varying interpretations over time. Accordingly, we are required to adopt new or
revised accounting standards or comply with revised interpretations that are issued from time to
time by recognized authoritative bodies, including the Financial Accounting Standards Board and the
SEC. Those changes could adversely affect our reported revenues, profitability, and financial
condition.
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 over
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.
12
SELLING SECURITY HOLDERS
We are registering 1,888,530 shares of our common stock for resale by the selling security
holders. We (in most contexts) use the term selling security holders to mean the security
holders named below and their transferees, pledgees, donees or other successors. Of the shares we
are registering, 888,889 were issued to institutional investors in a private placement offering
pursuant to a securities purchase agreement dated March 1, 2006. These institutional investors also
received warrants to purchase shares of common stock, which have an exercise price of $5.40 per
share (the 2006 Warrants). We are registering the 1,888,530 shares pursuant to registration
rights in the securities purchase agreement to permit the selling security holders to resell the
shares if and when they deem appropriate. The 1,888,530 shares include 888,889 shares of
outstanding common stock and 999,641 shares of common stock issuable upon exercise of certain of
the 2006 Warrants.
The following table sets forth (1) the names of the selling security holders; (2) the number
of shares of our common stock held by the selling security holders that may be offered for resale
pursuant to this prospectus as of June 10, 2009; (3) the number and percentage of shares of our
common stock that the selling security holder beneficially own prior to the offering for resale of
any of the shares of our common stock being registered hereby as of June 10, 2009; and (4) the
number and percentage of shares of common stock to be beneficially owned by the selling security
holder after the offering of the shares of our common stock being registered hereby, assuming, as
to each selling security holder, that all of the shares registered hereby are sold by such selling
security holder. We will not receive any proceeds from the resale of our common stock by the
selling security holder. Unless exercised on a cashless basis, we will receive proceeds from the
exercise of the 2006 Warrants, which we will use for general corporate purposes.
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Shares Beneficially |
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Shares Beneficially Owned |
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Owned After the |
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No. of Shares |
|
Prior to the Offering (2) |
|
Offering (3) |
Name |
|
Offered (1) |
|
Number |
|
Percentage |
|
Number |
|
Percentage |
Capital Ventures International (5) |
|
|
78,750 |
|
|
|
78,750 |
|
|
|
(4 |
) |
|
|
0 |
|
|
|
0.00 |
% |
Jennison Health Sciences Fund, a
series of Prudential
Sector Funds,
Inc., d/b/a
JennisonDryden Sector Fund (6) |
|
|
341,250 |
|
|
|
341,250 |
|
|
|
(4 |
) |
|
|
0 |
|
|
|
0.00 |
% |
Pacific Select Fund Health
Sciences Portfolio (7) |
|
|
50,750 |
|
|
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50,750 |
|
|
|
(4 |
) |
|
|
0 |
|
|
|
0.00 |
% |
|
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|
|
|
|
|
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|
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|
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|
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|
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OTA LLC (8) |
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140,000 |
|
|
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251,111 |
|
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(4 |
) |
|
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111,111 |
|
|
|
(4 |
) |
UBS OConnor LLC FBO OConnor PIPES
Corporate Strategies
Master Ltd. (9) |
|
|
77,779 |
|
|
|
77,779 |
|
|
|
(4 |
) |
|
|
0 |
|
|
|
0.00 |
% |
H&Q Healthcare Investors (10) |
|
|
780,001 |
|
|
|
780,001 |
|
|
|
0.01 |
% |
|
|
0 |
|
|
|
0.00 |
% |
H&Q Life Sciences Investors (11) |
|
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420,000 |
|
|
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420,000 |
|
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(4 |
) |
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0 |
|
|
|
0.00 |
% |
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(1) |
|
The number of shares included in this prospectus is subject to adjustment to prevent dilution
resulting from stock splits, stock dividends, the issuance of common stock or securities
convertible into or exercisable for common stock at prices below certain thresholds or similar
events. Therefore, pursuant to Rule 416 under the Securities Act, we are also registering such
indeterminate number of shares as may be issuable in connection with such issuable events.
Included in this column are 999,641 shares of common stock acquirable upon exercise of certain
of the 2006 Warrants, which became exercisable on September 4, 2006. |
|
(2) |
|
Includes all shares beneficially owned, whether directly or indirectly, individually or
together with associates, jointly or as community property with a spouse and shares to which
each individual has the right to acquire beneficial ownership within 60 days of June 10, 2009. |
|
(3) |
|
The percentage of shares of common stock beneficially owned by each stockholder after the
offering is based upon 90,244,618 shares of our common stock outstanding as of June 10, plus
shares of common stock as to which that particular holder has the right to acquire beneficial
ownership within 60 days of June 10, 2009. |
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(4) |
|
Less than 0.005%. |
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(5) |
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Heights Capital Management, Inc., the authorized agent of Capital Ventures International
(CVI), has discretionary authority to vote and dispose of the shares held by CVI and may be
deemed to be the beneficial owner of these shares. Martin Kobinger serves as the Investment
Manager of Heights Capital Management, Inc., with power to direct investments and/or power to
vote the shares owned by this entity, and may be deemed to beneficially own the shares held by
this entity. Martin Kobinger |
13
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expressly disclaims ownership of such shares. The number of shares being offered by this
prospectus by CVI represent 78,750 shares of common stock issuable upon exercise of warrants. |
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(6) |
|
Jennison Associates LLC serves as sub-advisor to the Jennison Health Sciences Fund, with
power to direct investments and/or power to vote the shares owned by this entity, as well as
shares owned by certain other clients, and may be deemed to beneficially own the shares held
by this entity. Jennison Associates LLC expressly disclaims ownership of such shares.
Jennison Associates LLC is a wholly-owned subsidiary of Prudential Financial, Inc., which is a
publicly traded financial services company. The number of shares being offered by this
prospectus by Jennison Health Sciences Fund represent 341,250 shares of common stock issuable
upon exercise of warrants. |
|
(7) |
|
Jennison Associates LLC serves as sub-advisor to Pacific Select Fund-Health Sciences
Portfolio with power to direct investments and/or power to vote the shares owned by this
entity, as well as shares owned by certain other clients, and may be deemed to beneficially
own the shares held by this entity. Jennison Associates LLC expressly disclaims ownership of
such shares. Jennison Associates LLC is a wholly-owned subsidiary of Prudential Financial,
Inc., which is a publicly traded financial services company. The number of shares being
offered by this prospectus by Pacific Select Fund-Health Sciences Portfolio represent 50,750
shares of common stock issuable upon exercise of warrants. |
|
(8) |
|
Ira M. Levanthal has the power to direct investments and/or power to vote the shares owned by
this entity, and may be deemed to beneficially own the shares held by this entity. The number
of shares being offered by this prospectus by OTA LLC represent 140,000 shares of common stock
issuable upon exercise of warrants. |
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(9) |
|
UBS OConnor LLC, a Cayman Islands company, is the investment manager of OConnor PIPES
Corporate Strategies Master Ltd., a Cayman Islands company, and as its investment manager has
voting and investment control of the securities of OConnor PIPES Corporate Strategies Master
Ltd. UBS OConnor LLC is a wholly owned subsidiary of UBS AG. The number of shares being
offered by this prospectus by OConnor PIPES Corporate Strategies Master Ltd. represent 77,779
shares of common stock issuable upon exercise of warrants. |
|
(10) |
|
Hambrecht & Quist Capital Management, LLC is the investment adviser to H&Q Healthcare
Investors. Daniel R. Omstead, Ph.D. is President of Hambrecht & Quist Capital Management, LLC
and a member of the portfolio management team and, as such, has voting, dispositive and
investment control over the securities held by H&Q Healthcare Investors. Dr. Omstead disclaims
beneficial ownership of these securities. The number of shares being offered by this
prospectus by H&Q Healthcare Investors represent 202,223 shares of common stock issuable upon
exercise of warrants. |
|
(11) |
|
Hambrecht & Quist Capital Management, LLC is the investment adviser to H&Q Life Sciences
Investors. Daniel R. Omstead, Ph.D. is President of Hambrecht & Quist Capital Management, LLC
and a member of the portfolio management team and, as such, has voting, dispositive and
investment control over the securities held by H&Q Life Sciences Investors. Dr. Omstead
disclaims beneficial ownership of these securities. The number of shares being offered by
this prospectus by H&Q Life Sciences Investors represent 108,889 shares of common stock
issuable upon exercise of warrants. |
PLAN OF DISTRIBUTION
The selling security holders may, from time to time, sell any or all of their shares of common
stock on any stock exchange, market or trading facility on which the shares are traded or in
private transactions. These sales may be at fixed prices, at market prices at the time of sale, at
varying prices determined at the time of sale or at negotiated prices. The selling security
holders may use any one or more of the following methods when selling shares:
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ordinary brokerage transactions and transactions in which the broker-dealer solicits
purchasers; |
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block trades in which the broker-dealer attempts to sell the shares as agent but may
position and resell a portion of the block as principal to facilitate the transaction; |
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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an exchange distribution in accordance with the rules of the applicable exchange; |
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privately negotiated transactions; |
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short sales; |
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broker-dealers may agree with the selling security holder to sell a specified number of
such shares at a stipulated price per share; |
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a combination of any such methods of sale; and |
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any other method permitted pursuant to applicable law. |
The selling security holders may also sell shares under Rule 144 under the Securities Act, if
available, rather than under this prospectus. The selling security holders are not obligated to,
and there is no assurance that any of the selling security holders will, sell all or any of the
shares we are registering. The selling security holders may transfer, devise or gift such shares
by other means not
14
described in this prospectus. The selling security holders may also engage in short sales
against the box, puts and calls and other transactions in our securities or derivatives of our
securities and may sell or deliver shares in connection with these trades.
Broker-dealers engaged by the selling security holders may arrange for other brokers-dealers
to participate in sales. Broker-dealers may receive commissions or discounts from the selling
security holders (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated. The selling security holders do not expect these
commissions and discounts to exceed what is customary in the types of transactions involved. Any
profits on the resale of shares of common stock by a broker-dealer acting as principal might be
deemed to be underwriting discounts or commissions under the Securities Act. Discounts,
concessions, commissions and similar selling expenses, if any, attributable to the sale of shares
will be borne by the selling security holders. Any or all of the selling security holders may
agree to indemnify any agent, dealer or broker-dealer that participates in transactions involving
sales of their shares if liabilities are imposed on that person under the Securities Act. The
selling security holders that are also broker-dealers are underwriters within the meaning of the
Securities Act. Jennison Health Sciences Fund, a series of Prudential Sector Funds, Inc., d/b/a
JennisonDryden Sector Fund, Pacific Select FundHealth Sciences Portfolio and Capital Ventures
International, each a selling security holder, is each an affiliate of a broker-dealer. OTA LLC is
a broker-dealer. Jennison Health Sciences Fund, a series of Prudential Sector Funds, Inc., d/b/a
JennisonDryden Sector Fund, Pacific Select FundHealth Sciences Portfolio, OTA LLC and Capital
Ventures International each purchased the 2006 Warrants that are exercisable for the shares of
common stock being offered by it under this prospectus in the ordinary course of business. At the
time of the purchase, none of Jennison Health Sciences Fund, a series of Prudential Sector Funds,
Inc., d/b/a JennisonDryden Sector Fund, Pacific Select FundHealth Sciences Portfolio, OTA LLC or
Capital Ventures International had any agreement or understanding, directly or indirectly, with any
person to distribute such securities.
Each of selling security holders may from time to time pledge or grant a security interest in
some or all of the shares of common stock owned by it and, if it defaults in the performance of any
of its secured obligations, the pledgees or secured parties may offer and sell the shares of common
stock from time to time under this prospectus as it may be supplemented from time to time, or under
an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the
Securities Act amending the list of selling security holders to include the pledgee, transferee or
other successors in interest as selling security holders under this prospectus.
The selling security holders also may transfer the shares of common stock in other
circumstances, in which case the transferees, pledgees or other successors in interest will be the
selling beneficial owners for purposes of this prospectus.
Each of the selling security holders has advised us that it has not entered into any
agreements, understandings or arrangements with any underwriters or broker-dealers regarding the
sale of its shares of common stock, and that there is no underwriter or coordinating broker acting
in connection with a proposed sale of shares of common stock by it. If we are notified by any
selling security holder that any material arrangement has been entered into with a broker-dealer
for the sale of shares of common stock, if required, we will file a supplement to this prospectus.
If any selling security holder uses this prospectus for any sale of the shares of common stock, it
will be subject to the prospectus delivery requirements of the Securities Act, unless an exemption
therefrom is available.
The anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of our
common stock and activities of the selling security holders.
MATERIAL CHANGES
There have been no material changes in our affairs since December 31, 2008, which have not
been described in our Annual Report on Form 10-K for the year ended December 31, 2008, as filed on
March 30, 2009, and as amended on April 30, 2009, with the SEC, our Quarterly Report on Form 10-Q
for the quarter ended March 31, 2009, as filed on May 11, 2009 with the SEC, and our Current
Reports on Form 8-K filed with the SEC, all of which are incorporated herein by reference as
described below.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale by the selling security holders of any
of the shares of common stock offered for resale through this prospectus. All proceeds from the
resale of the shares of our common stock offered for resale through this prospectus will be for the
account of the respective selling security holder. Unless exercised on a cashless basis, we will
receive
15
proceeds of $5,398,061 from the exercise of the warrants, the shares of common stock issuable
upon the exercise of which may be offered for resale through this prospectus, which we will use for
general corporate purposes.
LEGAL MATTERS
The validity of the shares of common stock being offered hereby will be passed upon for us by
Jones, Walker, Waechter, Poitevent, Carrère & Denègre, L.L.P., New Orleans, Louisiana.
EXPERTS
The consolidated financial statements of Akorn, Inc. appearing in Akorn Inc.s Annual Report
(Form 10-K) for the year ended December 31, 2008, and the effectiveness of Akorn Inc.s internal
control over financial reporting as of December 31, 2008 have been audited by Ernst & Young LLP,
independent registered public accounting firm, as set forth in their reports thereon (which report
on the consolidated financial statements contains an explanatory paragraph describing conditions
that raise substantial doubt about the Companys ability to continue as a going concern as
described in Note A to the consolidated financial statements), included therein, and incorporated
herein by reference. Such consolidated financial statements are incorporated herein by reference in
reliance upon such reports given on the authority of such firm as experts in accounting and
auditing.
The
consolidated financial statements as of December 31, 2007 and
for the two years in the period ended December 31, 2007 incorporated by
reference in this Prospectus have been so incorporated in reliance on the report of BDO Seidman,
LLP, an independent registered public accounting firm, incorporated herein by reference, given on
the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We have filed a Registration Statement on Form S-3 under the Securities Act, relating to the
shares of common stock being offered by this prospectus. This prospectus constitutes the
prospectus of Akorn, Inc., filed as part of the registration statement. It does not contain all
information in the registration statement, as certain portions have been omitted in accordance with
the rules and regulations of the SEC.
We are subject to the informational requirements of the Exchange Act, which requires us to
file reports, proxy statements and other information with the SEC. You may inspect any document we
file with the SEC at the SECs Public Reference Room at 100 F Street, N.E., Washington D.C. 20549.
Copies of such material can be obtained from the facility at prescribed rates. Please call the SEC
toll free at 1-800-SEC-0330 for information about its public reference room. Because we file
documents electronically with the SEC, you may also obtain this information by visiting the SECs
website at http://www.sec.gov or our website at http://www.akorn.com. You can also inspect reports
and other information we file at the offices of the Nasdaq Global Market, One Liberty Plaza, 165
Broadway, New York, NY 10006. Information contained in the web sites listed herein is not part of
this prospectus.
We will also provide to each person, including any beneficial owner, to whom a prospectus is
delivered, a copy of any or all of the information that has been incorporated by reference in this
prospectus but not delivered with the prospectus. Such information will be provided upon written
or oral request and at no cost to the requester. Any such request may be made by writing or
calling us at the following address or telephone number:
Akorn, Inc.
1925 W. Field Court, Suite 300
Lake Forest, Illinois 60045
Attention: General Counsel
(847) 279-6100
Exhibits to a document will not be provided unless they are specifically incorporated by
reference in that document.
Our statements in this prospectus about the contents of any contract or other document are not
necessarily complete. You should refer to the copy of our contract or other document we have filed
for complete information.
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You should rely only on the information incorporated by reference or provided in this
prospectus. We have not authorized anyone else to provide you with different information. The
selling security holders are not making an offer of these securities in any state where the offer
is not permitted. You should not assume that the information in this prospectus is accurate as of
any date other than the date on the front of the document. We furnish our shareholders with annual
reports containing audited financial statements.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to incorporate by reference some of the documents we file with it, which
means that we can disclose important information to you by referring you to those documents. This
prospectus incorporates important business and financial information about us which is not included
in or delivered with this prospectus. The information incorporated by reference is an important
part of, and is considered to be a part of, this prospectus, and information that we file later
with the SEC will automatically update and supersede this information.
We incorporate by reference the following documents:
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our Annual Report on Form 10-K for the year ended December 31, 2008, as filed on
March 30, 2009 and as amended on April 30, 2009; |
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our Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, as filed on
May 11, 2009; |
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our Current Reports on Form 8-K, including amendments thereto, filed with the SEC
since December 31, 2008, other than any information furnished pursuant to Item 2.02 or Item 7.01; |
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the description of our common stock contained in the section entitled Description of
Capital Stock and Convertible Securities, included in our Post Effective Amendment No. 2 to
Registration Statement on Form S-1, No. 333-119168 filed with the SEC on June 14, 2005, and any
amendment or report filed for the purpose of updating such description; and |
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all documents filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d)
of the Exchange Act, other than any information furnished pursuant to Item 2.02 or Item 7.01 of
Form 8-K, after the date of this prospectus and prior to the termination of the offering of shares
hereunder. |
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
Section 83A(1) of the Louisiana Business Corporation Law (LBCL) permits a corporation to
indemnify any person who was or is a party or is threatened to be made a party to any action, suit,
or proceeding, whether civil, criminal, administrative, or investigative, including any action by
or in the right of the corporation, by reason of the fact that he is or was a director, officer,
employee, or agent of the corporation, or is or was serving at the request of the corporation as a
director, officer, employee, or agent of another business, foreign or nonprofit corporation,
partnership, joint venture, or other enterprise, against expenses, including attorneys fees,
judgments, fines, and amounts paid in settlement actually and reasonably incurred by him in
connection with such action, suit, or proceeding if he acted in good faith and in a manner he
reasonably believed to be in, or not opposed to, the best interests of the corporation, and, with
respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was
unlawful.
Section 83A(2) of the LBCL provides that, in case of actions by or in the right of a
corporation, the indemnity shall be limited to expenses, including attorneys fees and amounts paid
in settlement not exceeding, in the judgment of the board of directors, the estimated expense of
litigating the action to conclusion, actually and reasonably incurred in connection with the
defense or settlement of such action, and that no indemnification shall be made in respect of any
claim, issue, or matter as to which such person shall have been adjudged by a court of competent
jurisdiction, after exhaustion of all appeals therefrom, to be liable for willful or intentional
misconduct in the performance of his duty to the corporation, unless, and only to the extent that
the court shall determine upon application that, despite the adjudication of liability but in view
of all the circumstances of the case, he is fairly and reasonably entitled to indemnity for such
expenses which the court shall deem proper.
Section 83(B) of the LBCL provides that to the extent that a director, officer, employee or
agent of a corporation has been successful on the merits or otherwise in defense of any such
action, suit or proceeding, or in defense of any claim, issue or matter therein, he shall be
indemnified against expenses (including attorneys fees) actually and reasonably incurred by him in
connection therewith.
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Any indemnification under Section 83A of the LBCL, unless ordered by the court, shall be made
by a corporation only as authorized in a specific case upon a determination that the applicable
standard of conduct has been met, and such determination shall be made:
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By the board of directors by a majority vote of a quorum consisting of directors who were
not parties to such action, suit, or proceeding, or |
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If such a quorum is not obtainable and the board of directors so directs, by independent
legal counsel, or |
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By the shareholders. |
Section 83(D) of the LBCL permits defense expenses to be paid by a corporation in advance of
the final disposition of the action, upon receipt of an undertaking by or on behalf of the
director, officer, employee or agent to repay such amount, unless it shall ultimately be determined
that he is entitled to be indemnified by the corporation.
The indemnification provided for by Section 83 of the LBCL shall not be deemed exclusive of
any other rights to which the person indemnified is entitled under any by-law, agreement,
authorization of shareholders or directors, regardless of whether directors authorizing such
indemnification are beneficiaries thereof, or otherwise, both as to action in his official capacity
and as to action in another capacity while holding such office, and shall continue as to a person
who has ceased to be a director, officer, employee, or agent and shall inure to the benefit of his
heirs and legal representatives; however, no such other indemnification measure shall permit
indemnification of any person for the results of such persons willful or intentional misconduct.
Section 24 of the LBCL provides that the articles of incorporation of a corporation may
contain a provision eliminating or limiting the personal liability of a director or officer to the
corporation or its shareholders for monetary damages for breach of fiduciary duty as a director or
officer, provided that such provision shall not eliminate or limit the liability of a director or
officer:
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For any breach of the directors or officers duty of loyalty to the corporation or its
shareholders; |
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For acts or omissions not in good faith or which involve intentional misconduct or a
knowing violation of law; |
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Who knowingly or without the exercise of reasonable care and inquiry votes in favor of a
dividend paid in violation of Louisiana law, any other unlawful distribution, payment or
return of assets to be made to the shareholders or stock purchases or redemptions in violation
of Louisiana law; or |
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For any transaction from which the director or officer derived an improper personal
benefit. |
Article XII of the Companys articles of incorporation contains the provisions permitted by
Section 24 of the LBCL.
Article V of the Companys by-laws makes mandatory the indemnification of any of the Companys
officers, directors, employees or agents against any expenses, including attorneys fees,
judgments, fines and amounts paid in settlement actually and reasonably incurred by him by reason
of his position as the Companys director, officer, employee or agent or serving in such position
at the Companys request of any business, foreign or non-profit corporation, partnership, joint
venture or other enterprise, if he acted in good faith and in a manner that he reasonably believed
to be in, or not opposed to, the best interest of the Company, and, in the case of a criminal
action or proceeding, with no reasonable cause to believe that his conduct was unlawful. However,
in case of actions by or in the right of the Company, the indemnity shall be limited to expenses
(including attorneys fees and amounts paid in settlement not exceeding, in the judgment of the
Companys board of directors, the estimated expense of litigating the action to conclusion)
actually and reasonably incurred in connection with the defense or settlement of such action.
No indemnification is permitted under Article V of the Companys by-laws in respect of any
matter as to which a director or officer shall have been finally adjudged by a court of competent
jurisdiction to be liable for willful or intentional misconduct or to have obtained an improper
personal benefit, unless, and only to the extent that the court shall determine upon application
that, in view of all the circumstances of the case, he is fairly and reasonably entitled to
indemnity for such expenses which the court shall deem proper.
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Article V of the Companys by-laws also provides that to the extent that a director, officer,
employee or agent of the Company has been successful on the merits or otherwise in defense of any
such action, suit or proceeding, or in defense of any claim, issue or matter therein, he shall be
indemnified against expenses (including attorneys fees) actually and reasonably incurred by him in
connection therewith.
Any indemnification under Article V of the Companys by-laws, unless ordered by the court,
shall be made by the Company only as authorized in a specific case upon a determination that the
applicable standard of conduct has been met, and such determination shall be made:
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By the board of directors by a majority vote of a quorum consisting of directors who
were not parties to such action, suit, or proceeding, or |
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If such a quorum is not obtainable and the board of directors so directs, by independent
legal counsel, or |
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By the shareholders. |
Article V of the Companys by-laws also provides that the expenses incurred in defending such
action shall be paid by the Company in advance of the final disposition of such action, upon
receipt of an undertaking by or on behalf of the director, officer, employee or agent to repay such
amount, unless it shall ultimately be determined that he is entitled to be indemnified by the
Company as authorized under Article V. However, the Companys board of directors may determine, by
special resolution, not to have the Company pay in advance the expenses incurred by any person in
the defense of any such action.
Article V further provides that indemnification granted thereunder shall not be deemed
exclusive of any other rights to which a director, officer, employee or agent is or may become
entitled, both as to action in his official capacity and as to action in another capacity while
holding such office, and shall continue as to a person who has ceased to be a director, officer,
employee or agent and shall inure to the benefit of his heirs and legal representatives.
Article V also permits the Company to procure insurance on behalf of any person who is or was
the Companys director, officer, employee or agent, or is or was serving in such position at the
Companys request of any business, foreign or non-profit corporation, partnership, joint venture or
other enterprise, against any liability asserted against or incurred by him in any such capacity,
or arising out of his status as such, whether or not the Company would have the power to indemnify
him against such liability under the LBCL. The Company maintains a directors and officers
liability insurance policy.
Insofar as indemnification for liabilities arising under the Securities Act my be permitted to
directors, officers or person controlling the Company pursuant to the foregoing provisions, the
Company has been informed that in the opinion of the SEC, such indemnification is against public
policy as expressed in the Securities Act and is therefore unenforceable.
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Until the completion of the resale of
the common stock included in this prospectus,
all dealers that effect transactions in these
securities, whether or not participating in
this offering, may be required to deliver a
prospectus. This is in addition to the
dealers obligation to deliver a prospectus
when acting as underwriters and with respect to
their unsold allotments or subscriptions.
Table of Contents
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About this Prospectus
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Forward-Looking Statements and Factors
Affecting Future Results
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Summary
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Risk Factors
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Selling security holders
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Plan of Distribution
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Material Changes
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Use of Proceeds
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Legal Matters
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Experts
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Where You Can Find More Information
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Information Incorporated by Reference
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Disclosure of Commission Position on
Indemnification for Securities Act Liabilities
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The Resale of
1,888,530 Shares
of
Common Stock
Offered by
Selling Security Holders
AKORN, INC.
PROSPECTUS
July
15, 2009
We have not authorized any dealer, salesperson or other person to give you written information
other than this prospectus or to make representations as to matters not stated in this prospectus.
You must not rely on unauthorized information. This prospectus is not an offer to sell these
securities or our solicitation of your offer to buy the securities in any jurisdiction where that
would not be permitted or legal. Neither the delivery of this prospectus nor any of the sales made
hereunder after the date of this prospectus shall create an implication that the information
contained herein or our affairs have not changed since the date hereof.