sv3
As filed with the Securities and Exchange Commission on August 23, 2005.
Registration No. 333-__________
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION
STATEMENT
AND POST-EFFECTIVE AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT NO. 333-119168
UNDER THE SECURITIES ACT OF 1933
Akorn, Inc.
(Exact name of Registrant as specified in its charter)
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Louisiana
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2834
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72-0717400 |
(State or other jurisdiction of
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(Primary Standard Industrial
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(I.R.S. Employer |
incorporation or organization)
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Classification Code Number)
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Identification No.) |
2500 Millbrook Drive, Buffalo Grove, Illinois 60089
(Address, including zip code, of Registrants principal executive offices)
Arthur S. Przybyl
President and Chief Executive Officer
Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove, Illinois 60089
(847) 279-6100
(Name, Address and Telephone Number of Agent for Service)
Copies to:
Kurt L. Kicklighter, Esq.
Luce, Forward, Hamilton & Scripps LLP
600 W. Broadway, Suite 2600
San Diego, California 92101
(619) 236-1414
Approximate date of commencement of proposed sale to public: As soon as practicable after the
effective date of this Registration Statement.
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. £
If any of the securities being registered on this form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. R
If this form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act of 1933, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. £
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act
of 1933, check the following box and list the Securities Act of 1933 registration statement number
of the earlier effective registration statement for the same offering. £
If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the
following box. £
CALCULATION OF REGISTRATION FEE
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Proposed maximum |
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Proposed |
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Title of each class of |
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Amount to be |
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offering price |
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maximum aggregate |
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Amount of |
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securities to be registered |
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registered |
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per security |
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offering price |
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registration fee |
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Common Stock |
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4,011,286 |
(1) |
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$2.71(2) |
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$ |
10,870,585 |
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$ |
1,280 |
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(1) |
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Includes 3,567,936 shares of common stock that could become issuable in respect of dividends
on our Series A Preferred Stock and Series B Preferred Stock from July 1, 2005 through
December 31, 2007, and 443,350 shares of common stock that are or could become issuable in
respect of earned and unpaid interest on our Convertible Tranche A Promissory Note and
Convertible Tranche B Promissory Note from September 1, 2005 through December 20, 2006.
Pursuant to Rule 429 under the Securities Act of 1933, the prospectus included in this
Registration Statement relates to 64,964,680 shares of common stock of the Registrant,
4,011,286 shares of which are registered hereby and the balance of which were previously
registered pursuant to Post-Effective Amendment No. 2 to a Registration Statement on Form S-1
(Registration No. 333-119168), as to which this Registration Statement constitutes
Post-Effective Amendment No. 3. As of August 1, 2005,
270,393 of the previously registered shares have been sold by selling security holders. |
(2) |
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Estimated solely for the purpose of calculating the registration fee, pursuant to Rule
457(c), based on the average of the high and low prices of the Registrants common stock as
reported on the American Stock Exchange for August 18, 2005, which date is within 5 business
days prior to the initial filing date of this Registration Statement. |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary
to delay its effective date until the Registrant shall file a further amendment which specifically
states that this Registration Statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall
become effective on such date as the Securities and Exchange Commission, acting pursuant to said
Section 8(a), may determine.
Pursuant to Rule 429 under the Securities Act of 1933, the prospectus included in this Registration
Statement is a combined prospectus and relates to the Registration Statement on Form S-1 (No.
333-119168) that was previously filed by the Registrant, as to which this constitutes
Post-Effective Amendment No. 3. Such Post-Effective Amendment shall hereafter become effective
concurrently with the effectiveness of this Registration Statement in accordance with Section 8(c)
of the Securities Act of 1933.
Prospectus dated August 23, 2005, subject to completion
PROSPECTUS
The information contained in this prospectus is not complete and may be changed. The selling
stockholders may not sell these securities pursuant to this prospectus until the registration
statement filed with the Securities and Exchange Commission is effective. This prospectus is not an
offer to sell these securities and is not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
64,964,680 Shares
Akorn, Inc.
Common Stock
This prospectus relates to the resale of 64,964,680 shares of our common stock by the selling
stockholders identified in this prospectus, which have been issued or reserved for issuance upon
the conversion or exercise of presently outstanding shares of Series A 6.0% Participating
Convertible Preferred Stock, shares of Series B 6.0% Participating Convertible Preferred Stock,
warrants and convertible notes, including shares estimated to be issuable in satisfaction of
accrued and unpaid dividends and interest on shares of preferred stock and convertible notes,
respectively.
We are registering 64,964,680 shares of our common stock for resale by the selling
stockholders identified in this prospectus on pages 14 through 17. The selling stockholders may
sell the shares of common stock described in this prospectus in public or private transactions, at
prevailing market prices, or at privately negotiated prices. The selling stockholders may sell
shares directly to purchasers or through brokers or dealers. Brokers or dealers may receive
compensation in the form of discounts, concessions or commissions from the selling stockholders. We
will not receive any of the proceeds from the sale of the shares by the selling stockholders. The
selling stockholders will receive all of the proceeds from the sale of the shares and will pay all
underwriting discounts and selling commissions, if any, applicable to the sale of the shares. We
will, in the ordinary course of business, receive proceeds from the issuance of shares upon
exercise of the warrants described in this prospectus. 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 stockholders and each selling stockholder reserves the
right to accept or reject, in whole or in part, any proposed purchase of shares. Accordingly, the
public offering price, the amount of any applicable underwriting discounts and commissions and the
net proceeds to the selling stockholders will be determined at the time of such sale by the selling
stockholders.
Our common stock is traded on the American Stock Exchange under the symbol AKN. On August
18, 2005, the last reported sales price of our common stock was $2.65 per share.
Investing in our common stock involves risks.
See Risk Factors beginning on page 5.
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 [_________], 2005
TABLE OF CONTENTS
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Page |
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ABOUT
THIS PROSPECTUS |
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1 |
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FORWARD-LOOKING STATEMENTS AND FACTORS AFFECTING FUTURE RESULTS |
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1 |
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SUMMARY |
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RISK FACTORS |
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5 |
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SELLING STOCKHOLDERS |
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PLAN OF DISTRIBUTION |
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USE OF PROCEEDS |
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LEGAL MATTERS |
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EXPERTS |
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WHERE YOU CAN FIND MORE INFORMATION |
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INFORMATION INCORPORATED BY REFERENCE |
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(i)
ABOUT THIS PROSPECTUS
You should rely only on the information contained or incorporated by reference in this
prospectus and any applicable prospectus supplements. We have not authorized anyone to provide you
with different information. The selling stockholders 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, unless the context
otherwise requires.
FORWARD-LOOKING STATEMENTS AND FACTORS AFFECTING FUTURE RESULTS
Certain statements in this prospectus, any prospectus supplement and the documents
incorporated by reference in this prospectus, constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act. When used in this prospectus, any
prospectus supplement and the documents incorporated by reference 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 5; |
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Our ability to resolve our Food and Drug Administration compliance issues at our
Decatur, Illinois manufacturing 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 to operate and grow our business; |
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The effects of federal, state and other governmental regulation of our business; |
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Our success in developing, manufacturing and acquiring new products; |
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Our success in developing, manufacturing and distributing new products through our
joint venture and licensing agreements; |
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Our ability to complete and validate our lyophilization facility and receive Food and
Drug Administration approval on a timely basis; |
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Our ability to bring new products to market and the effects of sales of such products on our financial results; |
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The effects of competition from generic pharmaceuticals and from other pharmaceutical companies; |
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Availability of raw materials needed to produce our products; and |
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Other factors referred to in this prospectus, any prospectus supplement and the
documents incorporated by reference in this prospectus. |
These and other factors may cause our actual results to differ materially from any
forward-looking statement. Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee future results, levels of activity,
performance, or achievements. You should not place undue reliance on these forward-looking
statements. Unless required by law, we undertake no obligation to update any of the forward-looking
statements after the filing of this prospectus to conform such statements to actual results or to
changes in our expectations, whether as a result of new information, future events or otherwise.
1
SUMMARY
This summary does not contain all of the information you should consider before buying shares
in this offering. You should read this entire prospectus carefully, including Risk Factors, any
prospectus supplement and the documents incorporated by reference in this prospectus before making
an investment decision.
Company Overview
We manufacture and market diagnostic and therapeutic pharmaceuticals in specialty areas such
as ophthalmology, rheumatology, anesthesia and antidotes, among others. Our customers include
physicians, optometrists, 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 has operations in New Jersey and is involved in manufacturing,
research and development, and administrative activities related to our ophthalmic and injectable
segments. We also have a number of strategic alliances discussed elsewhere in this prospectus for
the development and marketing of products.
We classify our operations into three identifiable business segments: ophthalmic, injectable
and contract services.
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.
Injectable Segment. We market a line of specialty injectable pharmaceutical products,
including antidotes, anesthesia, and products used in the treatment of rheumatoid arthritis and
pain management. These products are marketed to hospitals through wholesalers and other national
account customers, as well as directly to medical specialists.
Contract Services Segment. We manufacture products for third-party pharmaceutical and
biotechnology customers based on their specifications.
2
The Offering
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Issuer
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Akorn, Inc. |
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Address and Phone Number
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2500 Millbrook Drive Buffalo Grove, Illinois 60089 (847) 279-6100 |
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American Stock Exchange Trading Symbol
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AKN |
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Website
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www.akorn.com (information found on our website is not part of this prospectus) |
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Securities Offered
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Up to 64,964,680(1) shares of our common stock, no par value by the
selling stockholders. |
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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 |
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covered by this prospectus. We will receive proceeds from the exercise of the
warrants described in this prospectus. |
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Risk Factors
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In analyzing an investment in our common stock offered by this prospectus, you
should carefully consider the information set forth under Risk Factors. |
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We are registering the following number of shares of common stock: |
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Issuable upon conversion of our Series A Preferred Stock |
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38,612,993 |
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Issuable upon exercise of warrants issued to holders of our Series A Preferred Stock (the Series A Warrants) |
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5,986,399 |
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Issuable upon conversion of our Series B Preferred Stock |
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5,463,912 |
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Issuable upon exercise of Series B Warrants |
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1,566,668 |
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Issuable upon exercise of warrants held by AEG Partners LLC pursuant to a Stock Purchase Warrant dated August
31, 2004 (the AEG Warrants) |
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1,200,000 |
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Issuable upon conversion of the Convertible Tranche A Promissory Note in the aggregate principal amount of
$3,000,000 (the Tranche A Note) |
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2,033,825 |
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Issuable upon conversion of the Convertible Tranche B Promissory Note in the aggregate principal amount of
$2,000,000 (the Tranche B Note) |
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1,701,921 |
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Issuable upon exercise of the Tranche A Common Stock Purchase Warrants issued to the holders of the Tranche A
Note (the Tranche A Warrants) |
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1,000,000 |
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Issuable upon exercise of the Tranche B Common Stock Purchase Warrants issued to the holders of the Tranche B
Note (the Tranche B Warrants) |
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667,000 |
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Issuable upon exercise of warrants issued on October 7, 2003 as compensation for personal guarantees of our
senior bank debt (the Guaranty Warrants) |
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960,000 |
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Issuable upon exercise of warrants issued on October 7, 2003 in conjunction with the issuance of subordinated
notes in the aggregate principal amount of $2,767,139 (the Note Warrants) |
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276,714 |
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Previously issued upon exercise of Series A Warrants |
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2,135,578 |
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Previously issued upon conversion of our Series A Preferred Stock |
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1,943,742 |
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Previously issued upon conversion of our Series B Preferred Stock |
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669,428 |
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Previously issued to The John N. Kapoor Trust dated September 20, 1989 |
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746,500 |
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TOTAL |
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64,964,680 |
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Our Series A Preferred Stock and our Series B Preferred Stock each accrue dividends, which if
not paid in cash as scheduled, increase the number of shares of common stock into which such
preferred stock is convertible. Included in the shares listed above are 3,567,936 shares of common
stock that could become issuable in respect of dividends on our Series A Preferred Stock and Series
B Preferred Stock from July 1, 2005 through December 31, 2007 and 443,350 shares of common stock
that are or could become issuable in respect of earned and unpaid interest on our Convertible
Tranche A Promissory Note and Convertible Tranche B Promissory Note from September 1, 2005 through
December 20, 2006. The number of shares of common stock set forth above 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, we are also registering such indeterminate number
of shares as may be issuable in connection with stock splits, stock dividends or similar events.
Other than holders of the Series B Preferred Stock and Series B Warrants, who have direct
registration rights for this offering, each of the holders of each of the other securities listed
above have piggy back registration rights for this offering.
3
We have reserved for issuance the shares of our common stock identified in this prospectus.
Each of the above listed securities which are being sold by the selling stockholders were
restricted securities under the Securities Act of 1933, or the Securities Act, prior to this
registration. The selling stockholders will determine if and when they will sell their shares and
if they will sell their shares at the current market price or at negotiated prices at the time of
the sale. Although we have agreed to pay the expenses related to the registration of the shares
being offered, we will not receive any proceeds from the sale of the shares by the selling
stockholders.
4
RISK FACTORS
You should carefully consider the following risk factors and all other information contained
in this prospectus and the documents incorporated by reference in this prospectus before investing.
Investing in our common stock involves a high degree of risk. The risks and uncertainties described
below are not the only ones we face. Additional risks and uncertainties not presently known to us
or that we currently believe are immaterial also may impair our business. If any of the events
described in the following risks occur, our business, results of operations and financial condition
could be materially adversely affected. In addition, the trading price of our common stock could
decline due to any of the events described in these risks, and you may lose all or part of your
investment.
Risks Related to Us
Our Decatur, Illinois manufacturing facility is the subject of an FDA warning letter.
The Food and Drug Administration, or FDA, issued a warning letter to us in October 2000
following a routine inspection of our Decatur manufacturing facility. An FDA warning letter is
intended to provide notice to a company of violations of the laws administered by the FDA and to
elicit voluntary corrective action. Until the violations identified in the warning letter are
corrected, the FDA frequently will withhold approval of any marketing applications (abbreviated new
drug applications, or ANDAs, and new drug applications, or NDAs ) submitted by the company and
will share contents of the warning letter with other government agencies (for example, the Veterans
Administration or Department of Defense) that may contract to purchase products from the company.
Failure to take effective corrective actions can result in FDA enforcement action such as monetary
fines, seizure of products, or injunction that could suspend manufacturing and compel recall of
product.
The warning letter addressed several deviations from regulatory requirements identified during
the inspection and requested that we take corrective actions. Since then, additional FDA
inspections in 2002, 2003 and 2004 found that certain deviations continued unresolved and
identified additional deviations. We have invested approximately $2,000,000 in facility
improvements, augmented personnel resources, enhanced process controls and have developed a
comprehensive corrective action plan. We have been in regular communications with the FDA and have
provided periodic reports of our progress in making corrections. In 2004, the FDA conducted two
additional inspections of our Decatur manufacturing facility. The first, concluded on April 7,
2004, identified several deviations for which we provided the FDA with proposed corrective actions.
The FDA initiated no enforcement action. Rather, the FDA notified us that another confirmatory
inspection would be made to determine whether the deviations identified had been corrected. The
confirmatory inspection concluded November 19, 2004. It identified deviations and we provided a
written response to the FDA identifying our corrective actions. We met with the FDA in January 2005
and provided the status of these corrective actions. The FDA has not initiated any enforcement
action. In a June 15, 2005 letter, the FDA provided comments and feedback on our response to the
findings of the November 2004 inspection. This letter stated that the FDA would conduct another
inspection of our Decatur manufacturing facility. It further advised that the upcoming inspection
must show correction of the findings of FDAs previous inspections and substantial compliance with
all applicable regulatory requirements, or, at a minimum, an ongoing credible effort to achieve
such compliance before it could consider changing the companys regulatory status. If the findings
of the next FDA inspection confirm substantial compliance, the FDA is expected to remove the
sanctions of the warning letter. If the FDAs inspection determines that our Decatur facility is
not in substantial compliance, the FDA may initiate enforcement action including the following: (1)
maintain the warning letter sanctions or issue a new warning letter; (2) seek a court-ordered
injunction which may include suspension of some or all operations at the Decatur manufacturing
facility until compliance is achieved and may require recall of products and monetary penalties
and/or other sanctions; or (3) seize our products produced at the Decatur manufacturing facility.
Any of these actions could significantly impair our ability to continue to manufacture and
distribute products, generate cash from our operations and may result in a covenant violation under
our senior debt.
To date, the noncompliance of our Decatur manufacturing facility has prevented us from
developing additional products at Decatur, some of which cannot be developed at our other
manufacturing facility. The inability to fully use our Decatur manufacturing facility has had a
material adverse effect on our business, financial condition and results of operations.
Unless and until we correct the FDA deviations at our Decatur manufacturing facility, it is
doubtful that the FDA will approve any applications that may be submitted by us for products to be
manufactured in Decatur. This has adversely impacted, and is likely to continue to adversely impact
our ability to grow sales.
5
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 and negative cash flows from operations may continue in the future
and there can be no assurance that our financial outlook will improve. For the six months ended
June 30, 2005 and 2004, we experienced operating losses of $2,441,000 and $2,084,000, respectively,
and for the years ended December 31, 2004 and 2003, our operating losses were $368,000 and
$6,276,000, respectively. We experienced negative cash flows from operations for the six months
ended June 30, 2005 and 2004 of $2,118,000 and $1,201,000, respectively, and for the years ended
December 31, 2004 and 2003 of $3,461,000 and $1,932,000, respectively. There can be no assurance
that our results of operations will improve in the future. If our results of operations do not
improve in the future, your investment in our common stock could be negatively affected.
We have invested significant resources in the development of lyophilization manufacturing
capability, and we may not realize the benefit of these efforts and expenditures.
We are in the process of completing an expansion of our Decatur, Illinois manufacturing
facility to add capacity to provide lyophilization manufacturing services, a manufacturing
capability we currently do not have. Subject to among other things, our ability to generate
operating cash flow or to obtain new financing for future operations, validation and approval of
the lyophilization facility by the FDA is anticipated in late 2005. Manufacturing capabilities for
lyophilized products are projected to be in place by mid-2006.
As of June 30, 2005, we had spent approximately $18,743,000 on the lyophilization expansion
and anticipate the need to spend approximately $2,000,000 of additional funds (excluding
capitalized interest) to complete the expansion. The majority of the additional spending will be
focused on validation testing of the lyophilization facility as the major capital equipment items
are currently in place. To this end, we expect to use a portion of the proceeds we obtained from
the sale of our Series B Preferred Stock to help fund validation efforts for the lyophilization
facility and to fund the development of an internal ANDA lyophilized product pipeline. However,
there is no guarantee that we will be successful in completing development of lyophilization
capability, or that other intervening events will not occur that reduce or eliminate the
anticipated benefits from such capability. For instance, the market for lyophilized products could
significantly diminish or be eliminated, or new technological advances could render the
lyophilization process obsolete, prior to our entry into the market. There can be no assurance
that we will realize the anticipated benefits from our significant investment into lyophilization
capability at our Decatur manufacturing facility, and our failure to do so could significantly
limit our ability to grow our business in the future.
We depend on a small number of distributors, the loss of any of which could have a material
adverse effect.
A small number of large wholesale drug distributors account for a large portion of our gross
sales, revenues and accounts receivable. The following three distributors, AmerisourceBergen
Corporation, Cardinal Health, Inc. and McKesson Drug Company, accounted for approximately 59% of
total gross sales and 44% of net revenues for the six months ended June 30, 2005, and 76% of gross
trade receivables as of June 30, 2005. AmerisourceBergen Corporation, Cardinal Health, Inc. and
McKesson Drug Company accounted for approximately 57% of total gross sales and 46% of net revenues
in 2004, and 74% of gross trade receivables as of December 31, 2004. In addition to acting as
distributors of our products, these three companies also distribute a broad range of health care
products for many other companies. The loss of one or more of these distributors, together with a
delay or inability to secure an alternative distribution source for end users, could have a
material negative impact on our revenue and results of operations and lead to a violation of debt
covenants. A change in purchasing patterns or 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 chairman and a significant shareholder who was formerly a director are subject to
conflicts of interest.
Dr. John N. Kapoor, Ph.D., our current chairman of our board of directors and our chief
executive officer from March 2001 to December 2002, and a principal shareholder, is affiliated with
EJ Financial Enterprises, Inc., a health care consulting investment company. EJ Financial is
involved in the management of health care companies in various fields, and Dr. Kapoor is involved
in various capacities with the management and operation of these companies. The 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. In addition, one of these companies,
NeoPharm, Inc., of which Dr. Kapoor is a director and major stockholder, entered into a loan
agreement with us and issued to us a promissory note in the original principal amount of $3,250,000
(the NeoPharm Note). On
6
May 16, 2005, we paid all principal and interest due under the NeoPharm
Note with a one-time cash payment of $2,500,000. We also owe EJ Financial $11,000, $18,000, $18,000
and $18,000 in consulting fees for each of 2004, 2003, 2002 and 2001, respectively, as well as
expense reimbursements of approximately $2,000, $2,000, $2,000 and $79,000 for 2004, 2003, 2002 and
2001, respectively. Further, the Kapoor Trust has loaned us $5,000,000 resulting in Dr. Kapoor
effectively becoming a major creditor of ours as well as a major shareholder. As a result of the
relationships described above, Dr. Kapoors interests may be different from yours. Potential
conflicts of interest could have a material adverse effect on our business, financial condition and
results of operations.
In addition, the Kapoor Trust, Mr. Arjun C. Waney and Argent Fund Management collectively hold
subordinated promissory notes issued by us in the aggregate principal amount of approximately
$2,767,000 (the 2003 Subordinated Notes). Mr. Waney, one of our former directors and a continuing
owner of 4.90% of our outstanding shares of common stock, serves as chairman and managing director
of Argent, 52% of which is owned by Mr. Waney. The 2003 Subordinated Notes mature on April 7, 2006
and bear interest at prime plus 1.75%, but interest payments are currently prohibited under the
terms of subordination arrangements with LaSalle Bank. Potential conflicts of interest could have
a material adverse effect on our business, financial condition and results of operations.
We may require additional capital to grow our business and such funds may not be available to
us.
We may require additional funds to grow our business. 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 due to our recent financial history. Without sufficient additional funding, we may be unable
to pursue growth opportunities that we view as essential to the expansion of our business,
including the development of lyophilization manufacturing capability at our Decatur manufacturing
facility. Further, the terms of such additional financing, if obtained, likely will require the
granting of rights, preferences or privileges senior to those of our common stock and result in
substantial dilution of the existing ownership interests of our common stockholders and could
include covenants and restrictions that limit our ability to operate or expand our business in a
manner that we deem to be in our best interest.
Our growth depends on our ability to timely develop additional pharmaceutical products and
manufacturing capabilities.
Our strategy for growth is dependent upon our ability to develop products that can be promoted
through current marketing and distributions channels and, when appropriate, the enhancement of such
marketing and distribution channels. We may not meet our anticipated time schedule for the filing
of ANDAs and NDAs or may decide not to pursue ANDAs or NDAs that we have submitted or anticipate
submitting. Our internal development of new pharmaceutical products is dependent upon the research
and development capabilities of our personnel and our infrastructure. There can be no assurance
that we will successfully develop new pharmaceutical products or, if developed, successfully
integrate new products into our existing product lines. In addition, there can be no assurance that
we will receive all necessary FDA approvals or that such approvals will not involve delays, which
adversely affect the marketing and sale of our products. Unless and until our issues pending before
the FDA are resolved, it is doubtful that the FDA will approve any NDAs or ANDAs we submit for
products to be manufactured at our Decatur manufacturing facility. Our failure to develop new
products, to successfully resolve the compliance issues at our Decatur manufacturing facility or to
receive FDA approval of ANDAs or NDAs, could have a material adverse effect on our business,
financial condition and results of operations. See Our Decatur, Illinois manufacturing facility
is the subject of an FDA warning letter.
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. In 2004, we entered into certain purchase and supply
agreements, license agreements, and a joint venture that are all designed to provide finished
dosage form products that can be marketed through our distribution pipeline. However, there can be
no assurance that any of these agreements will result in FDA-approved ANDAs or NDAs, or that we
will be able to market any such finished dosage form products at a profit. In addition, any
clinical trial expenses that we incur may result in adverse financial consequences to our business.
7
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
federal and state governments, as is reimbursement for generic drug dispensing. There can be no
assurance that substitution will be permitted for newly approved generic drugs or that such
products will be subject to government reimbursement. In addition, generic products that third
parties develop may render our generic products noncompetitive or obsolete. There can be no
assurance that we will be able to consistently bring generic pharmaceutical products to market
quickly and efficiently in the future. An increase in competition in the sale of generic
pharmaceutical products or our failure to bring such products to market before our competitors
could have a material adverse effect on our business, financial condition and results of
operations.
Further, there is no proprietary protection for most of the branded pharmaceutical products
that either we or other pharmaceutical companies sell. In addition, governmental and
cost-containment pressures regarding the dispensing of generic equivalents will likely result in
generic substitution and competition generally for our branded pharmaceutical products. We attempt
to mitigate the effect of this substitution through, among other things, creation of strong
brand-name recognition and product-line extensions for our branded pharmaceutical products, but
there can be no assurance that we will be successful in these efforts.
We are subject to legal proceedings against us, which may prove costly and time-consuming even
if meritless.
We are currently involved in several pending or threatened legal actions with both private
parties and certain government agencies. To the extent that our personnel must spend time and we
must expend resources to pursue or contest these various matters, or any additional matters that
may be asserted from the time to time in the future, this represents time and money that is not
available for other actions that we might otherwise pursue which could be beneficial to our future.
In addition, to the extent that we are unsuccessful in any legal proceedings, the consequences
could have a negative impact on our business, financial condition and results of operations.
Our revenues depend on sales 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 third-party manufacturers we use will be able to provide us with
sufficient quantities of our products or that the products supplied to us will meet our
specifications. Any delays or difficulties with third-party manufacturers could adversely affect
the marketing and distribution of certain of our products, which could have a material adverse
effect on our business, financial condition and results of operations.
Dependence on key executive officers.
Our success will depend, in part, on our ability to attract and retain key executive officers.
We are particularly dependent upon Dr. John N. Kapoor, Ph.D., chairman of our board of directors,
and Mr. Arthur S. Przybyl, our chief executive officer. The inability to attract and retain key
executive officers, or the loss of one or more of our key executive officers could have a material
adverse effect on our business, financial condition and results of operations.
We must continue to attract and retain key personnel to be able to compete successfully.
Our performance depends, to a large extent, on the continued service of our key research and
development personnel, other technical employees, managers and sales personnel and our ability to
continue to attract and retain such personnel. Competition for such personnel is intense,
particularly for highly motivated and experienced research and development and other technical
personnel. We are facing increasing competition from companies with greater financial resources for
such personnel. There can be no assurance that we will be able to attract and retain sufficient
numbers of highly skilled personnel in the future, and the inability to do so could have a material
adverse effect on our business, operating results and financial condition.
8
Risks Related to Our Industry
We are subject to extensive government regulations that increase our costs and could subject
us to fines and liabilities, 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, the Drug Enforcement
Administration, or DEA, the 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 regulatory requirements can result in fines, injunctions, penalties,
mandatory recalls or seizures, suspensions of production, recommendations by the FDA against
governmental contracts and criminal prosecution. Any of these could have a material adverse effect
on our business, financial condition and results of operations. New, modified and additional
regulations, statutes or legal interpretation, if any, could, among other things, require changes
to manufacturing methods, expanded or different labeling, the recall, replacement or
discontinuation of certain products, additional record keeping and expanded documentation of the
properties of certain products and scientific substantiation. Such changes or new legislation could
have a material adverse effect on our business, financial condition and results of operations.
FDA regulations. All pharmaceutical manufacturers, including us, are subject to regulation by
the FDA under the authority of the federal Food, Drug and Cosmetic Act, or the FDC Act. Under
the FDC Act, the federal government has extensive administrative and judicial enforcement powers
over the activities of pharmaceutical manufacturers to ensure compliance with FDA regulations.
Those powers include, but are not limited to, the authority to initiate court action to seize
unapproved or non-complying products, to enjoin non-complying activities, to halt manufacturing
operations that are not in compliance with Current Good Manufacturing Practices, to recall
products, and to seek civil monetary and criminal penalties. 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 our New Credit Facility.
We must obtain approval from the FDA for each pharmaceutical product that we market. The FDA
approval process is typically lengthy and expensive, and approval is never certain. Our new
products could take a significantly longer time than we expect to gain regulatory approval and may
never gain approval. Even if the FDA or another regulatory agency approves a product, the approval
may limit the indicated uses for a product, may otherwise limit our ability to promote, sell and
distribute a product or may require post-marketing studies or impose other post-marketing
obligations.
We and our third-party manufacturers are subject to periodic inspection by the FDA to assure
regulatory compliance regarding the manufacturing, distribution, and promotion of sterile
pharmaceutical products. The FDA imposes stringent mandatory requirements on the manufacture and
distribution of sterile pharmaceutical products to ensure their sterility. The FDA also regulates
drug labeling and the advertising of prescription drugs. A finding by a governmental agency or
court that we are not in compliance with FDA requirements could have a material adverse effect on
our business, financial condition and results of operations.
If the FDA changes its regulatory position, it could force us to delay or suspend
indefinitely, our manufacturing, distribution or sales of certain products. While we believe that
all of our current pharmaceuticals are lawfully marketed in the United States under current FDA
enforcement policies or have received the requisite agency approvals for manufacture and sale, such
marketing authority is subject to withdrawal by the FDA. In addition, modifications or enhancements
of approved products are in many circumstances subject to additional FDA approvals which may or may
not be granted and which may be subject to a lengthy application process. Any change in the FDAs
enforcement policy or any decision by the FDA to require an approved NDA or ANDA for one of our
products not currently subject to the approved NDA or ANDA requirements or any delay in the FDA
approving an NDA or ANDA for one of our products could have a material adverse effect on our
business, financial condition and results of operations.
A number of products we market are grandfathered drugs that are permitted to be manufactured
and marketed without FDA-issued ANDAs or NDAs on the basis of their having been marketed prior to
enactment of relevant sections of the FDC Act. The
9
regulatory status of these products is subject
to change and/or challenge by the FDA, which could establish new standards and limitations for
manufacturing and marketing such products, or challenge the evidence of prior manufacturing and
marketing upon which grandfathering status is based. We are not aware of any current efforts by the
FDA to change the status of any of our grandfathered products, but there can be no assurance that
such initiatives will not occur in the future. Any such change in the status of our grandfathered
products could have a material adverse effect on our business, financial condition and results of
operations.
We are subject to extensive DEA regulation, which could result in our being fined or otherwise
penalized. We also manufacture and sell drugs which are controlled substances as defined in the
federal Controlled Substances Act and similar state laws, which established, among other things,
certain licensing, security and record keeping requirements administered by the DEA and similar
state agencies, as well as quotas for the manufacture, purchase and sale of controlled substances.
The DEA could limit or reduce the amount of controlled substances which we are permitted to
manufacture and market. On March 6, 2002, we received a letter from the United States Attorneys
Office, Central District of Illinois, Springfield, Illinois, advising us that the DEA had referred
a matter to that office for a possible civil legal action for alleged violations of the
Comprehensive Drug Abuse Prevention Control Act of 1970, 21 U.S.C. § 801 et. seq., and regulations
promulgated thereunder. The alleged violations relate to record keeping and controls surrounding
the storage and distribution of controlled substances. On November 6, 2002, we entered into a Civil
Consent Decree with the DEA. Under the terms of the Civil Consent Decree, without admitting any of
the allegations in the complaint from the DEA, we agreed to pay a fine of $100,000, upgrade our
security system and to remain in substantial compliance with the Comprehensive Drug Abuse
Prevention Control Act of 1970. If we failed to remain in substantial compliance during the
two-year period following the entry of the Civil Consent Decree, we, in addition to other possible
sanctions, might have been held in contempt of court and ordered to pay an additional $300,000
fine. We completed the upgrades to our security system in 2003 and have received no further notice
from the DEA in connection with the Civil Consent Decree. The two-year compliance period lapsed on
November 6, 2004. We were inspected by the DEA in February 2005 and the DEA has not informed us of
any further violations.
We may implement product recalls and could be exposed to significant product liability claims;
we may have to pay significant amounts to those harmed and may suffer from adverse publicity as a
result.
The manufacturing and marketing of pharmaceuticals involves an inherent risk that our products
may prove to be defective and cause a health risk. In that event, we may voluntarily implement a
recall or market withdrawal or may be required to do so by a regulatory authority. We have recalled
products in the past and, based on this experience, believe that the occurrence of a recall could
result in significant costs to us, potential disruptions in the supply of our products to our
customers and adverse publicity, all of which could harm our ability to market our products. There
were no product recalls in 2004. In February 2003, we recalled two products, Fluress and
Fluoracaine, due to container/closure integrity problems resulting in leaking containers. The
recall was classified by the FDA as a Class II Recall, which means that the use of, or exposure to,
a violative product may cause temporary or medically reversible adverse health consequences or that
the probability of serious health consequences as a result of such use or exposure is remote. We
had not received any notification or complaints from end users of the recalled products. Because we
had curtailed the production of these products due to the above container/closure integrity issues,
the financial impact to us of this recall was not material as our customers did not hold
significant inventories of these products. We began production of Fluress and re-started
distribution in September 2004. We have discontinued production of Fluoracaine.
Although we are not currently subject to any material product liability proceedings, we may
incur material liabilities relating to product liability claims in the future. Even meritless
claims could subject us to adverse publicity, hinder us from securing insurance coverage in the
future and require us to incur significant legal fees and divert the attention of the key employees
from running our business. Successful product liability claims brought against us could have a
material adverse effect on our business, financial condition and results of operations.
We currently have product liability insurance in the amount of $5,000,000 for aggregate annual
claims with a $50,000 deductible per incident and a $250,000 aggregate annual deductible. However,
there can be no assurance that such insurance coverage will be sufficient to fully cover potential
claims. Additionally, there can be no assurance that adequate insurance coverage will be available
in the future at acceptable costs, if at all, or that a product liability claim would not have a
material adverse effect on our business, financial condition and results of operations.
10
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: (1) we will be able to develop or acquire
commercially attractive pharmaceutical products; (2) additional competitors will not enter the
market; or (3) 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: (1) successfully
challenge our patents or proprietary rights; (2) obtain patents or proprietary rights that may have
an adverse effect on our ability to conduct business; or (3) 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 therefrom. 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.
11
Risks Related to an Investment in Our Common Stock
There is a limited market for our common stock.
The price at which you may be able to sell shares of our common stock is very unpredictable
because there are very few trades in our common stock. Because our common stock is so thinly
traded, a large block of shares traded can lead to a dramatic fluctuation in the share price.
Concentrated ownership of our common stock and our registration of shares for public sale
creates a risk of sudden changes in our share price.
The sale by any of our large shareholders of a significant portion of that shareholders
holdings could have a material adverse effect on the market price of our common stock. The
registration statement on Form S-3, of which this prospectus is a
part, registers up to 64,964,680
shares of our common stock for sale by certain of our investors. Sales of these shares on the open
market could cause the price of our common stock to decline.
Exercise of warrants and the conversion of subordinated debt and preferred stock may have a
substantial dilutive effect on our common stock.
If the price per share of our common stock at the time of exercise or conversion of any
preferred stock, warrants, options, convertible subordinated debt, or any other convertible
securities is in excess of the various exercise or conversion prices of such convertible
securities, exercise or conversion of such convertible securities would have a dilutive effect on
our common stock. As of June 30, 2005, holders of our convertible securities would receive
43,872,991 shares of our common stock upon conversion and holders of our outstanding warrants and
options would receive 15,926,356 shares of our common stock at a weighted average exercise price of
$1.77 per share. The amount of such dilution that may result from the exercise or conversion of
the foregoing, however, cannot currently be determined as it would depend on the difference between
our common stock price and the price at which such convertible securities were exercised or
converted at the time of such exercise or conversion. Any additional financing that we secure
likely will require the granting of rights, preferences or privileges senior to those of our common
stock and which result in substantial dilution of the existing ownership interests of our common
shareholders.
The terms of our preferred stock may reduce the value of your common stock.
We are authorized to issue up to a total of 5,000,000 shares of preferred stock in one or more
series. As of June 30, 2005, we had 242,172 shares of Series A Preferred Stock and 123,500 shares
of Series B Preferred Stock outstanding, and 4,601,828 additional shares of preferred stock remain
authorized for issuance. Our board of directors may determine whether to issue additional shares
of preferred stock and the terms of such preferred stock without further action by holders of our
common stock. If we issue additional shares of preferred stock, it could affect your rights or
reduce the value of our common stock. In particular, specific rights granted to future holders of
preferred stock could be used to restrict our ability to merge with or sell our assets to a third
party. These terms may include voting rights, preferences as to dividends and liquidation,
conversion and redemption rights, and sinking fund provisions. We continue to seek capital for the
growth of our business, and this additional capital may be raised through the issuance of
additional preferred stock.
Our obligations to pay dividends on our preferred stock decrease the returns available to our
common shareholders.
Our Series A Preferred Stock and Series B Preferred Stock both bear cumulative dividends at
the rate of 6.0%. These dividends are payable in cash, or in our discretion, in additional
conversion rights. If dividends are paid in cash, this decreases our working capital available for
operations. If dividends are paid in additional conversion rights, this results in further dilution
of the holders of our common stock. In either case, the equity per outstanding share of common
stock declines, which can cause a decrease in the value of our common stock.
12
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.
Trading in our common stock is subject to the penny stock rules. The SEC has adopted
regulations that generally define a penny stock to be any equity security that has a market price
of less than $5.00 per share, subject to certain exceptions. These rules require that any
broker-dealer that recommends our common stock to persons other than prior customers and accredited
investors, must, prior to the sale, make a special written suitability determination for the
purchaser and receive the purchasers written agreement to execute the transaction. Unless an
exception is available, the regulations require the delivery, prior to any transaction involving a
penny stock, of a disclosure schedule explaining the penny stock market and the risks associated
with trading in the penny stock market. In addition, broker-dealers must disclose commissions
payable to both the broker-dealer and the registered representative and current quotations for the
securities they offer. The additional burdens imposed upon broker-dealers by such requirements may
discourage broker-dealers from effecting transactions in our common stock, which could severely
limit the market price and liquidity of our common stock.
The requirements of being a public company may strain our resources and distract management.
As a public company, we are subject to the reporting requirements of the Securities Exchange
Act of 1934, or the Exchange Act, and the Sarbanes-Oxley Act of 2002. These requirements are
extensive. The Exchange Act requires that we file annual, quarterly and current reports with
respect to our business and financial condition. The Sarbanes-Oxley Act requires that we maintain
effective disclosure controls and procedures and internal controls for financial reporting. In
order to maintain and improve the effectiveness of our disclosure controls and procedures and
internal control over financial reporting, significant resources and management oversight is
required. This may divert managements attention from other business concerns, which could have a
material adverse effect on our business, financial condition and results of operations.
13
SELLING STOCKHOLDERS
We are registering 64,964,680 shares of our common stock for resale by the selling
stockholders named below. The term selling stockholders includes each stockholder named below and
such stockholders transferees, pledgees, donees or other successors.
Background
In this registration statement, we are registering 5,463,912 shares of common stock issuable
upon the conversion of shares of Series B Preferred Stock, all of which were purchased by
institutional investors in a private placement offering pursuant to subscription agreements between
us and each institutional investor dated August 18, 2004, including shares estimated to be issuable
in satisfaction of dividends accrued and unpaid through December 31, 2007. These selling
stockholders also received Series B Warrants to purchase an aggregate of 1,566,668 shares of common
stock, which have an exercise price of $3.50 per share of common stock. We are registering the
shares of common stock issuable upon conversion of the shares of Series B Preferred Stock pursuant
to registration rights in each of the subscription agreements to permit the institutional investors
and their respective transferees to resell the shares when they deem appropriate.
In addition, we are registering (a) 38,612,993 shares of common stock issuable upon conversion
of our Series A Preferred Stock, plus (b) 5,986,399 shares of common stock issuable upon exercise
of the Series A Warrants held by the holders of our Series A Preferred Stock, plus (c) 3,735,746
shares of common stock in the aggregate issuable upon conversion of the Tranche A Note and the
Tranche B Note including shares estimated to be issuable in satisfaction of interest accrued and
unpaid through December 20, 2006, and 1,667,000 shares of common stock issuable upon exercise of
the Tranche A Warrant and the Tranche B Warrant, plus (d) 1,200,000 shares of common stock issuable
upon exercise of the AEG Warrants, plus (e) 960,000 shares of common stock issuable upon exercise
of the Guaranty Warrants, plus (f) 276,714 shares issuable upon exercise of the Note Warrants, plus
(g) 2,135,578 shares of common stock previously issued upon exercise of the Series A Warrants, plus
(h) 669,428 shares of common stock previously issued upon conversion of our Series B Preferred
Stock, plus (j) 1,943,742 shares of common stock previously issued upon conversion of our Series A
Preferred Stock, plus (k) 746,500 shares of common stock held by
the Kapoor Trust. The holders of the foregoing securities have piggy back registration rights in
this offering.
The following table sets forth (1) the names of the selling stockholders; (2) the number of
shares of our common stock held by the selling stockholders that may be offered for resale pursuant
to this prospectus as of August 1, 2005, including the number of shares of our common stock
potentially issuable in satisfaction of accrued and unpaid dividends through December 31, 2007 as
to the preferred stock and accrued and unpaid interest through December 20, 2006 as to the
convertible notes; (3) the number and percentage of shares of our common stock that the selling
stockholders beneficially own prior to the offering for resale of any of the shares of our common
stock being registered hereby as of June 30, 2005; and (4) the number and percentage of shares of
common stock to be beneficially owned by the selling stockholders after the offering of the shares
of our common stock being registered hereby, assuming all of the shares registered hereby are sold
by the selling stockholders. We will not receive any proceeds from the resale of our common stock
by the selling stockholders. We will receive proceeds from the conversion of the warrants described
in the previous two paragraphs, which we will use for general corporate purposes.
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Shares Beneficially |
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Shares
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Owned After the |
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No. of Shares |
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Prior to the Offering(3) |
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Offering(4) |
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Offered(2) |
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AEG Partners LLC(5) |
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1,200,000 |
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4.41 |
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* |
|
Abu Alam |
|
|
48,193 |
|
|
|
170,507 |
|
|
|
* |
|
|
|
125,216 |
|
|
|
* |
|
Argent Fund Management Ltd.(6) |
|
|
520,103 |
|
|
|
947,579 |
|
|
|
3.58 |
% |
|
|
458,500 |
|
|
|
1.76 |
% |
Arun K. Puri Living Trust(7) |
|
|
1,927,777 |
|
|
|
1,811,667 |
|
|
|
6.51 |
% |
|
|
|
|
|
|
* |
|
Baystar Capital II, L.P.(8) |
|
|
2,674,885 |
|
|
|
2,490,719 |
|
|
|
8.77 |
% |
|
|
|
|
|
|
* |
|
The John N. Kapoor Trust(16) |
|
|
27,935,660 |
|
|
|
30,352,002 |
|
|
|
58.34 |
% |
|
|
4,088,900 |
|
|
|
15.42 |
% |
JRJAY Public Investments, LLC(9) |
|
|
1,586,768 |
|
|
|
1,689,568 |
|
|
|
6.50 |
% |
|
|
|
|
|
|
|
|
Merlin BioMed Long Term |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Appreciation, L.P.(10) |
|
|
169,025 |
|
|
|
150,255 |
|
|
|
* |
|
|
|
|
|
|
|
* |
|
Merlin BioMed Offshore Fund(11) |
|
|
394,396 |
|
|
|
350,597 |
|
|
|
1.33 |
% |
|
|
|
|
|
|
* |
|
Millennium Partners, L.P.(12) |
|
|
743,119 |
|
|
|
743,119 |
|
|
|
2.84 |
% |
|
|
|
|
|
|
* |
|
Morgan Stanley & Co. Incorporated(13) |
|
|
563,422 |
|
|
|
644,453 |
|
|
|
2.43 |
% |
|
|
143,600 |
|
|
|
* |
|
Pequot Capital Management, Inc.(14) |
|
|
18,239,336 |
|
|
|
17,897,612 |
|
|
|
43.68 |
% |
|
|
900,000 |
|
|
|
3.46 |
% |
Arthur S. Przybyl |
|
|
202,416 |
|
|
|
1,272,672 |
|
|
|
4.67 |
% |
|
|
1,082,447 |
|
|
|
4.00 |
% |
John Sabat |
|
|
192,779 |
|
|
|
280,197 |
|
|
|
1.07 |
% |
|
|
99,031 |
|
|
|
* |
|
Shritin Shah |
|
|
48,193 |
|
|
|
74,041 |
|
|
|
* |
|
|
|
28,750 |
|
|
|
* |
|
Neill Shanahan |
|
|
19,277 |
|
|
|
91,409 |
|
|
|
* |
|
|
|
73,293 |
|
|
|
* |
|
Sigma Capital Associates, LLC(15) |
|
|
338,053 |
|
|
|
700,511 |
|
|
|
2.66 |
% |
|
|
400,000 |
|
|
|
1.54 |
% |
Jerry Treppel |
|
|
481,945 |
|
|
|
472,917 |
|
|
|
1.79 |
% |
|
|
20,000 |
|
|
|
* |
|
Arjun C. Waney |
|
|
3,995,558 |
|
|
|
5,187,338 |
|
|
|
17.42 |
% |
|
|
1,424,000 |
|
|
|
5.47 |
% |
Gulu C. Waney |
|
|
1,894,022 |
|
|
|
2,830,212 |
|
|
|
10.22 |
% |
|
|
1,052,300 |
|
|
|
4.05 |
% |
Jai S. Waney |
|
|
1,349,445 |
|
|
|
2,059,417 |
|
|
|
7.55 |
% |
|
|
791,250 |
|
|
|
3.04 |
% |
Wheaten Healthcare Partners LP(17) |
|
|
440,308 |
|
|
|
440,308 |
|
|
|
1.69 |
% |
|
|
|
|
|
|
* |
|
TOTAL |
|
|
64,964,680 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
|
* |
|
Represents less than 1%. |
|
(1) |
|
Dr. Kapoor, the trustee and sole beneficiary of the Kapoor Trust, has served as the chairman
of our board of directors since May 1995 and from December 1991 to January 1993. Dr. Kapoor
served as our chief executive officer from March 2001 to December 2002. Mr. Przybyl is our
president and chief executive officer, positions he has held since September 2002 and February
2003, respectively. Each of Messrs. Przybyl and Treppel has served on our board of directors
since November 2003. Mr. Waney served on our board of directors from November 2003 through May
2005, and serves as chairman and managing director of, and owns 52% of, Argent Fund Management
Ltd. Mr. Treppel is the managing member of the general partner of Wheaten Healthcare Partners
LP. AEG served as our restructuring consultant during 2002 and 2003. To our knowledge, the
persons named in the table have sole voting and investment power with respect to all shares of
common stock shown as beneficially owned by them, subject to community property laws, where
applicable, and the information contained in the footnotes to this table. |
|
(2) |
|
Our Series A Preferred Stock and our Series B Preferred Stock each accrue dividends, which if
not paid in cash as scheduled, increase the number of shares of common stock into which such
preferred stock is convertible. Included in the shares listed above are 3,567,936 shares of
common stock that could become issuable in respect of dividends on our Series A Preferred
Stock and Series B Preferred Stock from July 1, 2005 through December 31, 2007 and 443,350
shares of common stock that are or could become issuable in respect of earned and unpaid
interest on our Convertible Tranche A Promissory Note and Convertible Tranche B Promissory
Note from September 1, 2005 through December 20, 2006. 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 stock splits, stock dividends or similar events. |
|
(3) |
|
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 30, 2005,
by the exercise of stock options, warrants or otherwise. |
|
(4) |
|
Percentage of shares of common stock beneficially owned by each stockholder after the
offering is based upon 26,008,912 shares of our common stock outstanding as of June 30, 2005,
plus shares of common stock issuable within 60 days of such date upon the conversion of
preferred stock or notes and exercise of warrants held by that particular holder. However, we
did not treat as outstanding the common stock issuable upon the conversion of preferred stock
and related dividends or notes and related interest and the exercise of warrants held by
persons other than the particular holder. |
|
(5) |
|
Lawrence M. Adelman, Craig J. Dean and Michael P. Goldsmith, members of AEG Partners LLC,
have shared voting and investment power over the securities. |
|
(6) |
|
Arjun C. Waney, chairman, managing director and 52% owner of Argent Fund Management Ltd., has
voting and investment power over the securities. Mr. Waney disclaims beneficial ownership over
the securities. |
15
|
|
|
(7) |
|
Arun K. Puri is the trustee of the Arun K. Puri Living Trust and is the natural person with
voting and investment power over the securities. |
|
(8) |
|
Baystar Capital Management, LLC is the general partner of Baystar Capital II, L.P. Lawrence
Goldfarb is the sole managing member of Baystar Capital Management, LLC.
Mr. Goldfarb in his capacity as the managing member of Baystar
Capital Management, LLC, may be deemed to have the power to
vote or to direct the vote and to dispose or to direct the disposition of the shares
beneficially owned by Baystar Capital II, L.P. Mr. Goldfarb
disclaims beneficial ownership of the securities set forth in this prospectus except to
the extent of any indirect pecuniary interest therein. |
|
(9) |
|
Jeffrey R. Jay is the natural person with voting and investment power over the securities. |
|
(10) |
|
Merlin BioMed Group, LLC is the general partner of Merlin BioMed Long Term Appreciation LP.
Stuart T. Weisbrod, the managing member of Merlin BioMed Group, LLC, is the natural person
with voting and investment power over the securities. |
|
(11) |
|
Merlin BioMed Group, LLC is the general partner of Merlin BioMed Offshore Fund. Stuart T.
Weisbrod, the managing member of Merlin BioMed Group, LLC, is the natural person with voting
and investment power over the securities. |
|
(12) |
|
Millennium Management, LLC, a Delaware limited liability company, is the managing partner of
Millennium Partners, L.P., a Cayman Islands exempted limited partnership, and consequently may
be deemed to have voting control and investment discretion over securities owned by Millennium
Partners, L.P. Israel A. Englander is the sole managing member of Millennium Management, LLC.
As a result, Mr. Englander may be considered the beneficial owner of any shares deemed to be
beneficially owned by Millennium Management, LLC. The foregoing should not be construed in and
of itself as an admission by either Millennium Management, LLC or Mr. Englander as to
beneficial ownership of the shares owned by Millennium Partners, L.P. Certain affiliates of
Millennium Partners, L.P. are broker-dealers. Millennium Partners, L.P. purchased the
securities convertible or exercisable into the shares of common stock being offered by it
under this prospectus in the ordinary course of business, and at the time of the purchase of
such securities that are convertible or exercisable into the shares of common stock being
offered for resale under this prospectus, Millennium Partners, L.P. had no agreement or
understanding, directly or indirectly, with any person to distribute such securities or the
shares of common stock issuable upon conversion or exercise in violation of the Securities
Act. |
|
(13) |
|
Morgan Stanley & Co. Incorporated is a reporting company or a subsidiary of a reporting
company under the Exchange Act. Morgan Stanley & Co. Incorporated is a broker-dealer and, as
such, is an underwriter with respect to the shares it sells pursuant
to this prospectus. |
|
(14) |
|
Pequot Capital Management, Inc., is the investment manager/advisor to the below named funds
and exercises sole dispositive and investment power for all shares held of record by the funds
named below. Pequot Capital Management, Inc. holds voting power for all shares held of record
by the funds named below except for Premium Series PCC Limited, Cell 32, which voting power is
held by Premium Series PCC Limited, Cell 32. Arthur J. Samberg is the sole shareholder of
Pequot Capital Management, Inc. and disclaims beneficial ownership of the shares except for
his pecuniary interest. The number of shares being offered by this prospectus by Pequot
Capital Management, Inc. represent 963,890 shares held of record by Pequot Scout Fund, L.P.,
of which 797,223 shares of common stock are issuable upon conversion of Series A Preferred
Stock and 166,667 shares of common stock are issuable upon exercise of Series A Warrants;
963,890 shares held of record by Pequot Mariner Onshore Fund, L.P. (formerly known as Pequot
Navigator Onshore Fund, L.P.), of which 797,223 shares of common stock are issuable upon
conversion of Series A Preferred Stock and 166,667 shares of common stock are issuable upon
exercise of Series A Warrants; 6,479,631 shares held of record by Pequot Healthcare Fund,
L.P., of which 4,401,464 shares of common stock are issuable upon conversion of Series A
Preferred Stock, 920,167 shares of common stock have been issued upon exercise of Series A
Warrants, 929,633 shares of common stock are issuable upon conversion of Series B Preferred
Stock, and 228,367 shares of common stock are issuable upon exercise of Series B Warrants;
7,354,528 shares held of record by Pequot Healthcare Offshore Fund, Inc., of which 4,948,839
shares of common stock are issuable upon conversion of Series A Preferred Stock, 1,115,833
shares of common stock have been issued upon exercise of Series A Warrants, 1,100,697 shares
of common stock are issuable upon conversion of Series B Preferred Stock, 270,392 shares of
common stock are issuable upon exercise of Series B Warrants, and a transfer of 81,233 shares
of common stock to Pequot Healthcare Institutional Fund, L.P.; 577,466 shares held of record
by Pequot Healthcare Institutional Fund, L.P, of which 388,566 shares of common stock are
issuable upon conversion of Series A Preferred Stock, 81,233 shares of common stock
transferred from Pequot Healthcare Offshore Fund, Inc., and 21,230 shares of common stock
issuable upon exercise of Series B Warrants; 180,352 shares held of record by Premium Series
PCC |
16
|
|
|
|
|
Limited Cell 32, of which 144,785 shares of common stock are issuable upon conversion of
Series B Preferred Stock and 35,567 shares of common stock are issuable upon exercise of
Series B Warrants; and 1,719,579 shares held of record by Pequot Healthcare Holdings, LLC, of
which 1,422,246 shares of common stock are issuable upon conversion of Series A Preferred
Stock and 297,333 shares of common stock are issuable upon exercise of Series A Warrants. |
|
(15) |
|
Pursuant to an investment agreement, Sigma Capital Management, LLC has investment and voting
power with respect to the securities held by Sigma Capital Associates, LLC. Steven A. Cohen
controls Sigma Capital Management, LLC. Each of Sigma Capital Management, LLC and Mr. Cohen
disclaim beneficial ownership of any of the securities covered by this prospectus. |
|
(16) |
|
Dr. John N. Kapoor, trustee of the Kapoor Trust, is the natural person with voting and
investment power over the securities. |
|
(17) |
|
Jerry Treppel, the general partner of Wheaten Healthcare Partners LP, is the natural person
with voting and investment power over the securities. |
Of the shares set forth in the column Number of Shares Offered in the table above the
following table sets forth each selling stockholders (1) shares of common stock, (2) shares of
common stock issuable upon conversion of Series A Preferred Stock and related dividends, (3) shares
of common stock issuable upon exercise of Series A Warrants, (4) shares of common stock issuable
upon conversion of Series B Preferred Stock and related dividends, (5) shares of common stock
issuable upon exercise of Series B Warrants, and (6) shares of common stock issuable upon
conversion or exercise of warrants or any other security convertible into shares of common stock,
as applicable.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
|
|
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
Common |
|
|
Preferred |
|
|
Series A |
|
|
Preferred |
|
|
Series B |
|
|
|
|
|
|
|
Name |
|
Stock |
|
|
Stock(1) |
|
|
Warrants(2) |
|
|
Stock(3) |
|
|
Warrants(4) |
|
|
Other |
|
|
Total |
|
AEG Partners LLC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,200,000 |
(5) |
|
|
1,200,000 |
|
Abu Alam |
|
|
|
|
|
|
39,860 |
(6) |
|
|
8,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,193 |
|
Argent Fund Management Ltd. |
|
|
|
|
|
|
426,036 |
(7) |
|
|
89,067 |
|
|
|
|
|
|
|
|
|
|
|
5,000 |
(8) |
|
|
520,103 |
|
Arun K. Puri Living Trust |
|
|
|
|
|
|
1,594,444 |
(9) |
|
|
333,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,927,777 |
|
Baystar Capital II, L.P. |
|
|
92,976 |
|
|
|
|
|
|
|
|
|
|
|
2,026,353 |
(10) |
|
|
555,556 |
|
|
|
|
|
|
|
2,674,885 |
|
The John N. Kapoor Trust dtd
9/20/89 |
|
|
746,500 |
|
|
|
17,116,367 |
(11) |
|
|
3,578,333 |
|
|
|
|
|
|
|
|
|
|
|
6,494,460 |
(12) |
|
|
27,935,660 |
|
JRJAY Public Investments, LLC |
|
|
1,586,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,586,768 |
|
Merlin BioMed Long Term
Appreciation, L.P. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,692 |
(13) |
|
|
33,333 |
|
|
|
|
|
|
|
169,025 |
|
Merlin BioMed Offshore Fund |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
316,618 |
(14) |
|
|
77,778 |
|
|
|
|
|
|
|
394,396 |
|
Millennium Partners, L.P. |
|
|
576,452 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,667 |
|
|
|
|
|
|
|
743,119 |
|
Morgan Stanley & Co. Incorporated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
452,311 |
(15) |
|
|
111,111 |
|
|
|
|
|
|
|
563,422 |
|
Pequot Capital Management, Inc. |
|
|
2,036,000 |
|
|
|
12,755,561 |
(16) |
|
|
630,667 |
|
|
|
2,261,552 |
(17) |
|
|
555,556 |
|
|
|
|
|
|
|
18,239,336 |
|
Arthur S. Przybyl |
|
|
|
|
|
|
167,416 |
(18) |
|
|
35,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
202,416 |
|
John Sabat |
|
|
|
|
|
|
159,446 |
(19) |
|
|
33,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
192,779 |
|
Shritin Shah |
|
|
|
|
|
|
39,860 |
(20) |
|
|
8,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,193 |
|
Neill Shanahan |
|
|
|
|
|
|
15,944 |
(21) |
|
|
3,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,277 |
|
Sigma Capital Associates, LLC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
271,386 |
(22) |
|
|
66,667 |
|
|
|
|
|
|
|
338,053 |
|
Jerry Treppel |
|
|
|
|
|
|
398,612 |
(23) |
|
|
83,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
481,945 |
|
Arjun C. Waney |
|
|
|
|
|
|
3,188,891 |
(24) |
|
|
666,667 |
|
|
|
|
|
|
|
|
|
|
|
140,000 |
(25) |
|
|
3,995,558 |
|
Gulu C. Waney |
|
|
99,578 |
|
|
|
1,594,444 |
(26) |
|
|
200,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,894,022 |
|
Jai S. Waney |
|
|
|
|
|
|
1,116,112 |
(27) |
|
|
233,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,349,445 |
|
Wheaten Healthcare Partners LP |
|
|
356,974 |
|
|
|
|
|
|
|
83,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
440,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total: |
|
|
5,495,248 |
|
|
|
38,612,993 |
|
|
|
5,986,399 |
|
|
|
5,463,912 |
|
|
|
1,566,668 |
|
|
|
7,839,460 |
|
|
|
64,964,680 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Each share of Series A Preferred Stock is convertible into a number of shares of common stock
equal to the quotient obtained by dividing (x) $100 plus any accrued but unpaid dividends on
such share by (y) $0.75, as such numerator and denominator may be adjusted from time to time
pursuant to the anti-dilution provisions of our restated articles of incorporation. |
|
(2) |
|
Each Series A Warrant is convertible into one share of common stock, subject to anti-dilution
adjustments, at an exercise price of $1.00 per share of common stock. |
17
|
|
|
(3) |
|
Each share of Series B Preferred Stock is convertible into a number of shares of common stock
equal to the quotient obtained by dividing (x) $100 plus any accrued but unpaid dividends on
such share by (y) $2.70, as such numerator and denominator may be adjusted from time to time
pursuant to the anti-dilution provisions of our restated articles of incorporation. |
|
(4) |
|
Each Series B Warrant is convertible into one share of common stock, subject to anti-dilution
adjustments, at an exercise price of $3.50 per share of common stock. |
|
(5) |
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Shares of common stock issuable upon exercise of the AEG Warrants. |
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(6) |
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Includes 2,902 shares of common stock issuable under additional conversion rights accruing in
the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
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(7) |
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Includes 31,024 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
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(8) |
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Shares issuable upon exercise of Note Warrants. |
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(9) |
|
Includes 116,110 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
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(10) |
|
Includes 280,312 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006, December 31, 2006, March 31, 2007, June 30, 2007,
September 30, 2007 and December 31, 2007. |
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(11) |
|
Includes 1,246,438 shares of common stock issuable under additional conversion rights
accruing in the event cash dividends are not paid on September 30, 2005, December 31, 2005,
March 31, 2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
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(12) |
|
Includes 2,033,825 shares of common stock issuable upon conversion of the Tranche A Note and
related interest, 1,701,921 shares of common stock issuable upon conversion of the Tranche B
Note and related interest, 1,000,000 shares of common stock issuable upon exercise of the
Tranche A Warrant, 667,000 shares of common stock issuable upon exercise of the Tranche B
Warrant, 880,000 shares of common stock issuable upon exercise of Guaranty Warrants, and
211,714 shares of common stock issuable upon exercise of Note Warrants. |
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(13) |
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Includes 18,770 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006, December 31, 2006, March 31, 2007, June 30, 2007,
September 30, 2007 and December 31, 2007. |
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(14) |
|
Includes 43,799 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006, December 31, 2006, March 31, 2007, June 30, 2007,
September 30, 2007 and December 31, 2007. |
|
(15) |
|
Includes 62,569 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006, December 31, 2006, March 31, 2007, June 30, 2007,
September 30, 2007 and December 31, 2007. |
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(16) |
|
Includes 928,878 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
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(17) |
|
Includes 312,847 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006, December 31, 2006, March 31, 2007, June 30, 2007,
September 30, 2007 and December 31, 2007. |
18
|
|
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(18) |
|
Includes 12,191 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
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(19) |
|
Includes 11,613 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
|
(20) |
|
Includes 2,902 shares of common stock issuable under additional conversion rights accruing in
the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
|
(21) |
|
Includes 1,161 shares of common stock issuable under additional conversion rights accruing in
the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
|
(22) |
|
Includes 37,542 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006, December 31, 2006, March 31, 2007, June 30, 2007,
September 30, 2007 and December 31, 2007. |
|
(23) |
|
Includes 29,028 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
|
(24) |
|
Includes 232,220 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
|
(25) |
|
Includes 80,000 shares of common stock issuable upon exercise of Guaranty Warrants, and
60,000 shares of common stock issuable upon exercise of Note Warrants. |
|
(26) |
|
Includes 116,110 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
|
(27) |
|
Includes 81,278 shares of common stock issuable under additional conversion rights accruing
in the event cash dividends are not paid on September 30, 2005, December 31, 2005, March 31,
2006, June 30, 2006, September 30, 2006 and December 31, 2006. |
19
PLAN OF DISTRIBUTION
The shares of common stock offered for resale through this prospectus may be sold by the
selling stockholders and any of their pledgees, assignees and successors-in-interest (including
successors by gift, partnership distribution or other non-sale-related transfer effected after the
date of this prospectus), from time to time, in one or more transactions 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 stockholders may offer their shares of common stock in one or more of the
following transactions:
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On any national securities exchange or quotation service at which our common stock
may be listed or quoted at the time of sale; |
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In the over-the-counter market; |
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In private transactions; |
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Through options, swaps or other derivative securities (whether exchangelisted or otherwise); |
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By pledge to secure debts and other obligations; |
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In ordinary brokerage transactions and transactions in which the broker-dealer solicits purchases; |
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In block trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to facilitate the
transaction; |
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Through purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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In settlement of short sales; |
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Through the sale of a specified number of shares at a stipulated price per share by
agreement between broker-dealers and the selling stockholders; |
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Sales in other ways not involving market makers or established trading markets,
including direct sales to purchasers, sales effected through agents or other privately
negotiated transactions; |
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A combination of any of the above methods; or |
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Any other method permitted pursuant to applicable law. |
If required, we will distribute a supplement to this prospectus to describe material changes
in the terms of the offering.
The shares of common stock described in this prospectus may be sold from time to time directly
by the selling stockholders. Alternatively, the selling stockholders may from time to time offer
shares of common stock to or through underwriters, broker/dealers or agents. The selling
stockholders that are also broker-dealers are underwriters within the meaning of the Securities
Act. Morgan Stanley & Co. Incorporated, a selling stockholder, is a broker-dealer and, as such, is
an underwriter with respect to the shares it sells pursuant to this
prospectus. Millennium Partners, L.P., a selling stockholder, is an affiliate of a
broker-dealer. Millennium Partners purchased the securities convertible or exercisable into the
shares of common stock being offered by it under this prospectus in the ordinary course of
business, and at the time of the purchase of such securities that are convertible or exercisable
into the shares of common stock being offered for resale under this prospectus, Millennium Partners
had no agreement or understanding, directly or indirectly, with any person to distribute such
securities or the shares of common stock issuable upon conversion or exercise. The selling
stockholders and any broker or any broker-dealers, agents or underwriters that participate with the
selling stockholders in the distribution of the shares offered for resale through this prospectus
may also be deemed to be underwriters within the meaning of the Securities Act. In these cases,
any commissions received by these broker-dealers, agents or underwriters and any profit on the
resale of the shares offered for resale through this prospectus purchased by them may be deemed to
be underwriting commissions or discounts under the Securities Act. In addition, any profits
realized by the
20
selling stockholders may be deemed to be underwriting discounts and commissions
under the Securities Act. To the extent the selling stockholders may be deemed to be underwriters,
they will be subject to the prospectus delivery requirements of the Securities Act.
The selling stockholders may from time to time pledge or grant a security interest in some or
all of the shares and, if they default in the performance of any of their 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 provisions of the Securities Act amending the
list of selling stockholders to include the pledgee, transferee or other successors in interest as
selling stockholders under this prospectus.
The selling stockholders may also 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.
Any shares covered by this prospectus which qualify for sale pursuant to Rule 144 under the
Securities Act may be sold under Rule 144 rather than pursuant to this prospectus. The selling
stockholders are not obligated to, and there is no assurance that the selling stockholders will,
sell all or any of the shares we are registering. The selling stockholders may transfer, devise or
gift such shares by other means not described in this prospectus.
Under the Exchange Act, any person engaged in a distribution of our common stock may not
simultaneously engage in market-making activities with respect to our common stock for nine
business days prior to the start of the distribution. Each selling stockholder, and any other
person, who participates in a distribution of our common stock will be subject to the Exchange Act
which may limit the timing of purchases and sales of our common stock by such selling stockholder
or any such other person. These factors may affect the marketability of our common stock and the
ability of brokers or dealers to engage in market-making activities.
We will pay all expenses of this registration. These expenses include the filing fees of the
SEC, fees under state securities or blue sky laws, and accounting and legal fees. We estimate
that our expenses in connection with this registration will be approximately $83,280. All expenses
for the issuance of any supplement to this prospectus will be paid by us. The selling stockholders
may pay selling commissions or brokerage fees with respect to the sale of the resale shares by
them. Some of the selling stockholders will be indemnified by us against certain civil liabilities
under securities laws or will be entitled to contribution in connection therewith. We will be
indemnified by some of the selling stockholders against certain liabilities under securities laws
or will be entitled to contribution in connection therewith.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale by the selling stockholders 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
accounts of the selling stockholders. We will receive proceeds from the cash 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 financial statements incorporated by reference in this prospectus have been audited by BDO
Seidman, LLP, an independent registered public accounting firm, to the extent and for the periods
set forth in their report incorporated herein by reference, and are incorporated herein in reliance
upon such report given upon the authority of said firm as experts in auditing and accounting.
The financial statements for the year ended December 31, 2002 incorporated in this prospectus
and registration statement by reference from our Annual Report on Form 10-K for the year ended
December 31, 2004 have been audited by Deloitte & Touche LLP, an independent registered public
accounting firm, as stated in their report which is incorporated herein by reference, (which report
21
expresses an unqualified opinion and includes an explanatory paragraph relating to our ability to
continue as a going concern), and has been so incorporated in reliance upon the report of such firm
given upon their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed a Registration Statement on Form S-3 under the Securities Act, relating to the
shares of common stock being offered by this prospectus, and reference is made to such registration
statement. This prospectus constitutes the prospectus of Akorn, Inc., filed as part of the
registration statement, and it does not contain all information in the registration statement, as
certain portions have been omitted in accordance with the rules and regulations of the SEC.
We are subject to the informational requirements of the Exchange Act, which requires us to
file reports, proxy statements and other information with the SEC. Such reports, proxy statements
and other information may be inspected at public reference room of the SEC at Judiciary Plaza, 450
Fifth Street N.W., 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. Information contained in our web site is not part of this prospectus.
We will also provide to each person, including any beneficial owner, to whom a prospectus is
delivered, a copy of any or all of the information that has been incorporated by reference in this
prospectus but not delivered with the prospectus. Such information will be provided upon written
or oral request and at no cost to the requester. Any such request may be made by writing or
calling us at the following address or telephone number:
Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove, Illinois 60089
Attention: Chief Financial Officer
(847) 279-6100
Exhibits to a document will not be provided unless they are specifically incorporated by
reference in that document.
Our statements in this prospectus about the contents of any contract or other document are not
necessarily complete. You should refer to the copy of our contract or other document we have filed
for complete information.
You should rely only on the information incorporated by reference or provided in this
prospectus. We have not authorized anyone else to provide you with different information. The
selling stockholders 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 stockholders with annual
reports containing audited financial statements.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to incorporate by reference the information we file with them, 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 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, 2004, as filed on March 31, 2005; |
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our Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 and June 30,
2005, as filed on May 20, 2005 and August 8, 2005, respectively; |
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our Current Reports on Form 8-K filed on May 20, 2005, May 19, 2005, May 9, 2005,
April 19, 2005 and February 28, 2005; |
22
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our definitive Proxy Statement filed on April 13, 2005 in connection with our Annual
Meeting of Stockholders held on May 27, 2005; |
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the description of our common stock to be registered hereunder included 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 |
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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 after the date of this prospectus and prior to the termination of
the offering of shares hereunder. |
23
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The expenses in connection with the issuance and distribution of the securities being
registered in this registration statement are set forth in the following table. The selling
security holders will bear none of the following expenses. All amounts except the registration fee
are estimated.
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Registration Fees |
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$ |
1,280 |
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Transfer Agent Fees |
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1,000 |
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Legal Fees |
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25,000 |
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Accounting Fees |
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55,000 |
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Miscellaneous |
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1,000 |
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Total |
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$ |
83,280 |
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Item 15. Indemnification of Directors and Officers
Incorporated by reference to Item 15. Indemnification of Directors and Officers included in
Post-Effective No. 2 to our Registration Statement on Form S-1, No. 333-119168 filed with the SEC
on June 14, 2005.
Item 16. Exhibits
(a) Those exhibits marked with an asterisk (*) refer to exhibits filed herewith. The other
exhibits are incorporated herein by reference, as indicated in the following list.
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Exhibit No. |
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Description |
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4.1
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First Amendment dated October 7, 2003 to Registration Rights Agreement dated July 12, 2001
between the Company and The John N. Kapoor Trust dtd 9/20/89, incorporated by reference to
Exhibit 4.1 to the Companys report on Form 8-K filed on October 24, 2003. |
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4.2
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Form of Warrant Certificate, incorporated by reference to Exhibit 4.2 to the Companys report on
Form 8-K filed on October 24, 2003. |
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4.3
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Form of Warrant Agreement dated October 7, 2003 between the Company and certain investors,
incorporated by reference to Exhibit 4.3 to the Companys report on Form 8-K filed on October
24, 2003. |
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4.4
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Warrant Agreement dated October 7, 2003 between the Company and The John N. Kapoor Trust dtd
9/20/89 issued with respect to New Credit Facility guaranty, incorporated by reference to
Exhibit 4.4 to the Companys report on Form 8-K filed on October 24, 2003. |
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4.5
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Warrant Agreement dated October 7, 2003 between the Company and Arjun C. Waney issued with
respect to New Credit Facility guaranty, incorporated by reference to Exhibit 4.5 to the
Companys report on Form 8-K filed on October 24, 2003. |
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4.6
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Warrant Agreement dated October 7, 2003 between the Company and The John N. Kapoor Trust dtd
9/20/89 issued with respect to the Notes, incorporated by reference to Exhibit 4.6 to the
Companys report on Form 8-K filed on October 24, 2003. |
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4.7
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Warrant Agreement dated October 7, 2003 between the Company and Arjun C. Waney issued with
respect to the Notes, incorporated by reference to Exhibit 4.7 to the Companys report on Form
8-K filed on October 24, 2003. |
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4.8
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Warrant Agreement dated October 7, 2003 between the Company and Argent Fund Management issued
with respect to the Notes, incorporated by reference to Exhibit 4.8 to the Companys report on
Form 8-K filed on October 24, 2003. |
II-1
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4.9
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Registration Rights Agreement dated October 7, 2003 among the Company and certain investors,
incorporated by reference to Exhibit 4.9 to the Companys report on Form 8-K filed on October
24, 2003. |
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4.10
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Form of Subscription Agreement between the Company and certain investors, incorporated by
reference to Exhibit 4.1 to the Companys report on Form 8-K filed on August 24, 2004. |
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4.11
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Form of Common Stock Purchase Warrant between the Company and certain investors, incorporated by
reference to Exhibit 4.2 to the Companys report on Form 8-K filed on August 24, 2004. |
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4.12
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Warrant Purchase and Registration Agreement dated June 18, 2003 between the Company and AEG
Partners LLC, incorporated by reference to Exhibit 4.1 to the Companys report on Form 8-K filed
on August 27, 2004. |
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4.13
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Stock Registration Rights Agreement dated November 15, 1990 between the Company and The John N.
Kapoor Trust dtd 9/20/89, incorporated by reference to Exhibit 4.12 to the Companys
Registration Statement on Form S-1 filed on September 21, 2004. |
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4.14
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Stock Purchase Agreement dated November 15, 1990 between the Company and The John N. Kapoor
Trust dtd 9/20/89, incorporated by reference to Exhibit 4.13 to the Companys Registration
Statement on Form S-1 filed on September 21, 2004. |
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5.1*
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Opinion of Jones, Walker, Waechter, Poitevent, Carrère & Denègre, L.L.P. |
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23.1*
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Consent of BDO Seidman, LLP, independent registered public accounting firm. |
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23.2*
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Consent of Deloitte & Touche LLP, independent registered public accounting firm. |
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23.3*
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Consent of Jones, Walker, Waechter, Poitevent, Carrère & Denègre, LLP, incorporated by reference
to Exhibit 5.1 to this Registration Statement. |
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24.1
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Power of Attorney, incorporated by reference to the Signature Page of this Registration Statement |
Item 17. Undertakings
We hereby undertake:
(1) To file, during any period in which offers or sales are being made pursuant to this
registration statement, a post-effective amendment to this registration statement to include any
material information with respect to the plan of distribution not previously disclosed in the
registration statement or any material change to such information in the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof; and
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) For purposes of determining any liability under the Securities Act, each filing of the
Registrants annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act that is
incorporated by reference in the registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering thereof.
The undersigned Registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act of 1933, each filing of the Registrants annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 that is incorporated by reference in
this registration statement shall be deemed to be a new registration statement relating to the
securities offered herein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
II-2
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the Registrant pursuant to the
foregoing provisions or otherwise, the Registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act, and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the Registrant of expenses incurred or paid by a
director, officer or controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the Registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant certifies that it
has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and
has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Buffalo Grove, State of Illinois, on the 23rd day of
August, 2005.
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AKORN, INC.
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By: |
/s/ JEFFREY A. WHITNELL
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Jeffrey A. Whitnell |
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Chief Financial Officer,
Treasurer and Secretary |
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We, the undersigned officers and directors of Akorn, Inc., hereby severally constitute and
appoint each of Messrs. Arthur S. Przybyl and Jeffrey A. Whitnell as our true and lawful
attorneys-in-fact, with full power to each of them, to sign for us in our names in the capacities
indicated below, any amendments to this Registration Statement on Form S-3 including post-effective
amendments, and to file the same, with all exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission, and generally to do all things in our names
and on our behalf in our capacities as officers and directors to enable Akorn, Inc. to comply with
the provisions of the Securities Act of 1933, as amended, and all requirements of the Securities
and Exchange Commission, hereby ratifying and confirming our signatures as they may be signed by
our said attorneys-in-fact to said Registration Statement and any and all amendments thereto.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has
been signed below by the following persons in the capacities and on the dates indicated.
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Signature |
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Title
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Date |
/s/ ARTHUR S. PRZYBYL
Arthur S. Przybyl
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Director, President and Chief Executive Officer
(Principal Executive Officer)
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August 19, 2005 |
/s/ JEFFREY A. WHITNELL
Jeffrey A. Whitnell |
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Chief Financial Officer, Treasurer and
Secretary (Principal Financial Officer
and Principal Accounting Officer)
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August 19, 2005 |
/s/ JOHN N. KAPOOR
Dr. John N. Kapoor |
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Chairman and Director
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August 19, 2005 |
/s/ JERRY N. ELLIS
Jerry N. Ellis |
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Director
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August 19, 2005 |
/s/ JERRY TREPPEL
Jerry Treppel |
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Director
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August 19, 2005 |
/s/ RONALD M. JOHNSON
Ronald M. Johnson |
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Director
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August 19, 2005 |