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As filed with the Securities and Exchange Commission on November 5, 2010
Registration No. 333-155431
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
POST-EFFECTIVE AMENDMENT NO. 3 TO
FORM S-8
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
DUSA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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New Jersey
(State or Other Jurisdiction
of Incorporation or Organization)
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22-3103129
(I.R.S. Employer
Identification No.) |
25 Upton Drive
Wilmington, Massachusetts 01887
(Address of Principal Executive Offices) (Zip Code)
DUSA Pharmaceuticals, Inc. 2006 Equity Compensation Plan, As Amended
DUSA Pharmaceuticals, Inc. 1996 Omnibus Plan, As Amended
(Full Title of the Plan)
Nanette W. Mantell, Esq.
Reed Smith LLP
Princeton Forrestal Village
136 Main Street Suite 250
Princeton, New Jersey 08543-7839
(609) 514-8541
(Name and Address and Telephone of Agent for Service)
Copies to:
Robert F. Doman, President and Chief Executive Officer
DUSA Pharmaceuticals, Inc.
25 Upton Drive
Wilmington, Massachusetts 01887
(978) 657-7500
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one)
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Large accelerated filer o
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Non-accelerated filer þ
(do not check if smaller reporting company)
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Smaller reporting company o |
INTRODUCTORY STATEMENT
This Post-Effective Amendment to Registration Statements on Form S-8 constitutes
Post-Effective Amendment No. 3 to Registration Statement on Form S-8, Registration No. 333-155431,
filed November 18, 2008. This Post-Effective Amendment is being filed solely for the purpose of
updating the reoffer prospectus that forms a part of this Post-Effective Amendment relating to the
resale of control securities to be acquired by selling shareholders listed under the Selling
Securityholders section of the prospectus. The selling shareholders have acquired or will acquire
the securities pursuant to DUSAs various equity compensation plans. The reoffer prospectus
contained herein has been prepared in accordance with the requirements of Part I of Form S-3 and,
pursuant to General Instruction C of Form S-8, may be used for reoffers or resales of the shares
that have been or will be acquired by the selling security holders.
The inclusion of the individuals listed under the Selling Securityholders section of the
prospectus does not constitute a commitment to sell any or all of the stated number of shares of
common stock. The number of shares offered shall be determined from time to time by each selling
securityholder at their sole discretion and such individuals are listed as selling securityholders
solely to register the shares that each has received or will receive under DUSAs various equity
compensation plans.
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PROSPECTUS
357,500 Shares of Common Stock by Selling Securityholders
DUSA Pharmaceuticals, Inc.
The shares of common stock of DUSA Pharmaceuticals, Inc. covered by this prospectus may be
offered and sold to the public by certain selling securityholders of DUSA. The selling
securityholders have acquired or will acquire the shares under DUSAs 1996 Omnibus Plan, as amended
and the 2006 Equity Compensation Plan, as amended.
Our common stock is quoted on the Nasdaq Global Market under the symbol DUSA. On
November 4, 2010, the closing price of a share of our common stock on the Nasdaq Global Market
was $2.74 per share.
Investing
in our common stock involves risks. See Risk Factors beginning on page 2.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved these securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is November ___, 2010.
TABLE OF CONTENTS
You should rely only on the information contained in this prospectus or any supplement,
including the documents that we incorporate by reference. We have not authorized anyone to provide
you with information different from that which is contained in or incorporated by reference to this
prospectus. We are offering to sell shares of common stock and seeking offers to buy shares of
common stock only in jurisdictions where offers and sales are permitted. The information contained
in this prospectus is accurate only as of the date of the prospectus, regardless of the time of
delivery of this prospectus or of any sale of the common stock.
DUSA PHARMACEUTICALS, INC.
We are a vertically integrated dermatology company that is developing and marketing
Levulan® photodynamic therapy, or PDT, and other products for common skin conditions.
Our marketed products include Levulan® Kerastick® 20% Topical Solution with
PDT, the BLU-U® brand light source, and ClindaReach®.
We devote most of our resources to advancing the development and marketing of our
Levulan® PDT/PD technology platform. In addition to our marketed products, our drug,
Levulan® brand of aminolevulinic acid HCl, or ALA, in combination with light, has been
studied in a broad range of medical conditions. When Levulan® is used and followed with
exposure to light to treat a medical condition, it is known as Levulan® PDT. The
Kerastick® is our proprietary applicator that delivers Levulan®. The
BLU-U® is our patented light device.
The Levulan® Kerastick® 20% Topical Solution with PDT and the
BLU-U® were launched in the United States, or U.S., in September 2000 for the treatment
of non-hyperkeratotic actinic keratoses, or AKs, of the face or scalp under a former dermatology
collaboration. AKs are precancerous skin lesions caused by chronic sun exposure that can develop
over time into a form of skin cancer called squamous cell carcinoma. In addition, in September 2003
we received clearance from the United States Food and Drug Administration, or FDA, to market the
BLU-U® without Levulan® PDT for the treatment of moderate inflammatory acne
vulgaris and general dermatological conditions.
We merged with Sirius Laboratories, Inc., or Sirius, a dermatology specialty pharmaceuticals
company, in March 2006. Nicomide® was its key product, a vitamin-mineral product
prescribed by dermatologists, but we no longer market Nicomide®. We do market
ClindaReach® for the treatment of acne, which we acquired from Sirius.
We manufacture our Levulan® Kerastick®. We are also responsible for the
regulatory, sales, marketing, customer service and other related activities for all of our
products, including our Levulan® Kerastick®. We are marketing
Levulan® PDT under an exclusive worldwide license of patents and technology from PARTEQ
Research and Development Innovations, the licensing arm of Queens University, Kingston, Ontario,
Canada. We also own or license certain other patents relating to our BLU-U® device and
methods for using pharmaceutical formulations which contain our drug and related processes and
improvements. In the United States, DUSA®, DUSA Pharmaceuticals, Inc.®,
Levulan®, Kerastick®, BLU-U®, Nicomide®,
Nicomide-T®, ClindaReach®, Meted®, and Psoriacap® are
registered trademarks which we own. Several of these trademarks are also registered in Europe,
Australia, Canada, and in other parts of the world. Numerous other trademark applications are
pending.
As of September 30, 2010, we had an accumulated deficit of approximately $144,563,000. Our
financial goal for 2010 is to be cash flow positive and profitable on an annual basis, however, we
cannot guarantee that our products will achieve significant enough market acceptance or generate
sufficient revenues to achieve these goals or to sustain profitability if it is achieved. We must
increase sales from current levels in order for us to reach profitability on an annual basis. We
cannot provide assurance that an increase in sales will necessarily cause us to be profitable.
As of September 30, 2010, we had a staff of 89 employees, including 2 part-time employees who
worked across all operating functions at DUSA.
Unless the context otherwise requires, the terms we, our, us, the Company and DUSA
refer to DUSA Pharmaceuticals, Inc., a New Jersey corporation.
We were incorporated on February 21, 1991, under the laws of the State of New Jersey. Our
principal executive office is located at 25 Upton Drive, Wilmington, Massachusetts 01887
(telephone: (978) 657-7500) (web address: www.dusapharma.com).
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RISK FACTORS
Investing in our common stock is very speculative and involves a high degree of risk. You
should carefully consider and evaluate all of the information in, or incorporated by reference in,
this report. The following are among the risks we face related to our business, assets and
operations. They are not the only ones we face. Any of these risks could materially and adversely
affect our business, results of operations and financial condition, which in turn could materially
and adversely affect the trading price of our common stock and you might lose all or part of our
investment.
This report contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that involve risks and uncertainties, such as statements of our
plans, objectives, expectations and intentions. We use words such as anticipate, believe,
expect, future and intend and similar expressions to identify forward-looking statements. Our
actual business, financial condition and results of operations could differ materially from those
anticipated in these forward-looking statements for many reasons, including the factors described
below and elsewhere in this report. You should not place undue reliance on these forward-looking
statements, which apply only as of the date of this report.
Risks Related To DUSA
We May Not Be Profitable On An Annual Basis And May Not Be Profitable In The Future Unless We Can
Successfully Market And Sell Significantly Higher Quantities Of Our Products.
If We Do Not Become Profitable, We May Need More Capital
We have approximately $16,981,000 in cash, cash equivalents and marketable securities as of
September 30, 2010. Our cash, cash equivalents and marketable securities should be sufficient for
current operations for at least the next 12 months. If we are unable to become profitable on an
ongoing basis in the near term, we may have to reduce our headcount, curtail certain variable
expenses, or raise funds through financing transactions. We cannot predict whether financing will
be available at all or on reasonable terms.
If A Competitive Product Is Successful Our Revenues Could Decline, and Our Ability To Become
Profitable Could Be Delayed
On May 30, 2006, we entered into a patent license agreement with Photocure ASA whereby we
granted a non-exclusive license to Photocure under the patents we license from PARTEQ, for esters
of ALA. Furthermore, we granted a non-exclusive license to Photocure for its existing formulations
of its Hexvix® and Metvix® (known in the United States as
Metvixia® ) products for any of our patents that may issue or be licensed by us in the
future. Photocure received FDA approval to market Metvixia® for treatment of AKs in July
2004, and this product, which is directly competitive with our Levulan®
Kerastick® product, is commercially available. On October 1, 2009, Photocure announced
that it had sold Metvix/Metvixia to Galderma, S.A., a large dermatology company, and on January 11,
2010, Galderma announced a co-promotion agreement with PhotoMedex for Metvixia under which Galderma
is providing marketing support and distribution. PhotoMedex sales force is promoting Metvixia and
Galdermas Aktilite lamp to healthcare professionals throughout the United States. While we are
entitled to royalties on net sales of Metvixia, Galderma and PhotoMedex together have considerably
more resources than we have; which could adversely affect our ability to maintain or increase our
market share and make it more difficult for us to be profitable on an ongoing basis. In addition,
Leo Pharma, a Danish corporation that acquired Peplin in 2009, has announced that in 2012 it will
be launching PEP005 for the treatment of AKs. This product could negatively impact the market
penetration of our PDT products.
Any Failure To Comply With Ongoing Governmental Regulations In The United States And Elsewhere Will
Limit Our Ability To Market Our Products And Become Profitable.
The manufacture and marketing of our products are subject to continuing FDA review as well as
comprehensive regulation by the FDA and by state and local regulatory authorities. These laws
require, among other things:
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approval of manufacturing facilities, including adherence to good manufacturing and laboratory practices
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controlled research and testing of some of these products even after approval, |
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control of marketing activities, including advertising and labeling, and |
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state permits for the sale and distribution of products manufactured in and out-of-state. |
If we, or any of our contract manufacturers, fail to comply with these requirements, we may be
limited in the jurisdictions in which we are permitted to sell our products. Additionally, if we or
our manufacturers fail to comply with applicable regulatory approval requirements, a regulatory
agency may:
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send warning letters, |
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impose fines and other civil penalties on us, |
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seize our products, |
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suspend our regulatory approvals, |
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cease the manufacture of our products, |
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refuse to approve pending applications or supplements to approved applications filed by us, |
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refuse to permit exports of our products from the United States, |
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require us to recall products, |
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require us to notify physicians of labeling changes and/or product related problems, |
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impose restrictions on our operations, and/or |
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criminally prosecute us. |
We and our manufacturers must continue to comply with current Good Manufacturing Practice
regulations, or cGMP, and Quality System Regulations, or QSR, and equivalent foreign regulatory
requirements. The cGMP and QSR requirements govern quality control and documentation policies and
procedures. In complying with cGMP, QSR and foreign regulatory requirements, we and our third-party
manufacturers will be obligated to expend time, money and effort in production, record keeping and
quality control to assure that our products meet applicable specifications and other requirements.
Manufacturing facilities are subject to ongoing periodic inspection by the FDA, including
unannounced inspections. We cannot guarantee that our third-party supply sources, including our
sole source supplier for the active ingredient in Levulan® and the component parts in
the BLU-U®, or our own Kerastick® facility, will continue to meet all
applicable FDA regulations. If we, or any of our manufacturers, fail to maintain compliance with
FDA regulatory requirements, it would be time-consuming and costly to remedy the problem(s) or to
qualify other sources. These consequences could have a significant adverse effect on our financial
condition and operations. Additionally, if previously unknown problems with the product, a
manufacturer or its facility are discovered in the future, changes in product labeling restrictions
or withdrawal of the product from the market may occur. Any such problems could affect our ability
to become profitable on an ongoing basis.
During April 2010, we were advised that a receiver had been appointed for the laboratory that
we were using to perform analytical release testing and stability testing of our
Levulan® Kerastick® product due to non-payment of its bank loan. As a result,
that laboratory was no longer able to perform these services on an on-going basis. We are working
with this laboratory for the transfer of all samples, raw material and relevant technology. We
engaged the services of a new laboratory and have successfully transferred the technology and
analytical methods so that the new laboratory can perform all of the services we need. On May 5,
2010 following discussions with the FDA, we filed a 30-day Changes Being Effected (CBE-30)
supplement to validate the use of the new laboratory. FDA had no comment on the supplement during the 30 day period so we began shipping product as
permitted under FDA regulations. The FDA could still have comments on the CBE-30 and we would have
to respond. Any significant interruption in our ability to ship product caused by FDA could have a
negative effect on our revenues.
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If Product Sales Do Not Continue to Increase, We May Not Be Able To Advance Development Of Our
Other Potential Products As Quickly As We Would Like To, Which Would Delay The Approval Process And
Marketing Of New Potential Products, If Approved.
If we do not generate sufficient revenues from our approved products, we may be forced to
delay or abandon our development program for programs we may wish to initiate. The pharmaceutical
development and commercialization process is time consuming and costly, and any delays might result
in higher costs which could adversely affect our financial condition and results of operations.
Without sufficient product sales, we would need alternative sources of funding. There is no
guarantee that adequate funding sources could be found to continue the development of our
technology.
The Current Global Credit And Financial Market Conditions May Affect Our Business.
Sales of our products are dependent, in large part, on reimbursement from government health
and administration authorities, private health insurers, distribution partners and other
organizations. As a result of the current global credit and financial market conditions, government
authorities and private insurers may not satisfy their reimbursement obligations or may delay
payment. In addition, federal and state health authorities may reduce Medicare and Medicaid
reimbursements, and private insurers may increase their scrutiny of claims. A reduction in the
availability or extent of reimbursement could negatively affect our product sales and revenues.
Due to the tightening of global credit, there may be disruption or delay in the performance by
our third-party contractors, suppliers or collaborators. We rely on third parties for several
important aspects of our business, including the active ingredient in Levulan® and key
portion of the BLU-U®, portions of our product manufacturing, royalty revenues, conduct
of clinical trials and the supply of raw materials. If such third parties are unable to satisfy
their commitments to us, our business would be adversely affected.
If The Economic Slowdown Adversely Affects Our Customers Ability To Meet Our Payment Terms, Our
Cash Flow Would Be Adversely Affected And Our Ability To Achieve Profitability On An Annual Basis
Could Be Delayed.
If any of our large customers were to fail to pay us or fail to pay us on a timely basis for
their purchases of our products, our ability to maintain profitability on a sustainable on-going
basis could be delayed, and our financial position, results of operations and cash flows could be
negatively affected.
We Have Had Significant Losses And May Have Losses In The Future.
We have had a history of operating losses. We may continue to incur losses on an annual basis
unless sales of our products increase from present levels. We incurred net losses of $2,508,000,
$6,250,000 and $14,714,000 for the years ended December 31, 2009, 2008 and 2007, respectively, and
a loss of $203,000 for the nine-month period ended September 30, 2010. As of September 30, 2010,
our accumulated deficit was approximately $145,000,000. We expect to incur significant additional
research and development and other costs including costs related to preclinical studies and
clinical trials. Our costs, including research and development costs for our product candidates and
sales, marketing and promotion expenses for any of our existing or future products to be marketed
by us or our collaborators may exceed revenues in the future, which may result in future losses
from operations. We cannot predict whether any of our products will achieve significant enough
market acceptance or generate sufficient revenues to enable us to become profitable on an annual
basis, and to sustain profitability if it is achieved.
Our Ability To Use Net Operating Loss Carryforwards and Tax Credit Carryforwards To Offset Future
Taxable Income May Be Further Limited As A Result Of Past Or Future Transactions Involving Our
Common Stock.
Under Internal Revenue Code, or IRC, Section 382 the amount of our net operating loss
carryforwards and other tax attributes that we may utilize to offset future taxable income, when
earned, may be subject to certain limitations, based upon changes in the ownership of our common
stock. In general, under IRC Section 382, a corporation that undergoes an ownership change is
subject to limitations on its ability to utilize its pre-change net operating losses and certain
other tax assets to offset future taxable income. An ownership change occurs if the aggregate stock
ownership of certain shareholders increases by more than 50 percentage points over such
shareholders lowest percentage ownership during the testing period, which is generally three
years. Based on an IRC Section 382 study completed in early 2010, we have determined that an
ownership change occurred in 2007, and as a result, approximately $48.6 million of our net
operating loss carryforwards are expected to be available to us. Our net operating loss
carryforwards are subject to an annual limitation of approximately $3.0 million for the
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first five
years following the ownership change and $2.2 million annually thereafter through December 31,
2027. We further believe that it is reasonably possible that a future ownership change, which could
be the result of transactions involving our common stock that are outside of our control (such as
sales by existing shareholders), could occur. Future ownership changes could further restrict the
utilization of our net operating losses and tax credits, reducing or eliminating the benefit of
such net operating losses and tax credits.
If We Are Unable To Obtain The Necessary Capital To Fund Our Operations, We Will Have To Delay Our
Development Program And May Not Be Able To Complete Our Clinical Trials.
We may need substantial additional funds to fully develop, manufacture, market and sell other
potential products. We may obtain funds through other public or private financings, including
equity financing, and/or through collaborative arrangements. We may also choose to license rights
to third parties to commercialize products or technologies that we would otherwise have attempted
to develop and commercialize on our own which could reduce our potential revenues.
The availability of additional capital to us is uncertain. There can be no assurance that
additional funding will be available to us on favorable terms, if at all. Any equity financing, if
needed, would likely result in dilution to our existing shareholders, and debt financing, if
available, would likely involve significant cash payment obligations and could include restrictive
covenants that would adversely affect the operation of our business. Failure to raise capital, if
needed, could materially adversely affect our business, our financial condition, results of
operations and cash flows.
We Have Limited Patent Protection, And If We Are Unable To Protect Our Proprietary Rights,
Competitors Might Be Able To Develop Similar Products To Compete With Our Products And Technology.
Our ability to compete successfully depends, in part, on our ability to defend patents that
have issued, obtain new patents, protect trade secrets and operate without infringing the
proprietary rights of others. We have no compound patent protection for our Levulan®
brand of the compound ALA. Our basic ALA patents are for methods of detecting and treating various
diseased tissues using ALA (or related compounds called precursors), in combination with light. We
own or exclusively license ALA patents and patent applications related to the following:
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methods of using ALA and its unique physical forms in combination with light to treat conditions such as
AKs and acne, |
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compositions and apparatus for those methods, and |
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unique physical forms of ALA. |
We also own patents covering our Kerastick® and BLU-U®, which also cover
our AK therapy. However, other third parties may have blue light devices or drug delivery devices
that do not infringe our patents.
The patents relating to methods of using ALA for detecting or treating disease, other than for
acne and our approved indication for AKs of the face or scalp, started to expire in July 2009. With
the newly allowed claims which issued on May 25, 2010, we have claims that cover our AK product
until 2019. The reexamination by the USPTO of one of the patents we license from PARTEQ, the
licensor of our ALA patents, that cover our approved product until 2013, has successfully concluded
with affirmation of our original claims and the addition of eight new claims.
We have limited ALA patent protection outside the United States, which may make it easier for
third parties to compete there. Our basic methods of treatment patents and applications have
counterparts in only six foreign countries, and certain countries under the European Patent
Convention. Even where we have patent protection, there is no guarantee that we will be able to
enforce our patents. Additionally, enforcement of a given patent may not be practicable or an
economically viable alternative.
Some of the indications for which we may develop PDT therapies may not be covered by the
claims in any of our existing patents. Even with the issuance of additional patents to us, other
parties are free to develop other uses
of ALA, including medical uses, and to market ALA for such uses, assuming that they have obtained
appropriate regulatory marketing approvals. ALA in the chemical form has been commercially supplied
for decades, and is not itself subject to patent protection. There are reports of third parties
conducting clinical studies with ALA in countries outside the United States where PARTEQ does not
have patent protection. In addition, a number of third parties are
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seeking patents for uses of ALA
not covered by our patents. These other uses, whether patented or not, and the commercial
availability of ALA, could limit the scope of our future operations because ALA products could come
on the market which would not infringe our patents but would compete with our Levulan®
product even though they are marketed for different uses.
Photocure ASA received FDA approval to market Metvixia® for treatment of AKs in
July 2004, and this product, which is directly competitive with our Levulan®
Kerastick® product, is commercially available. On October 1, 2009, Photocure announced
that it had sold Metvix/Metvixia to Galderma, S.A., a large dermatology company. On January 11,
2010, Galderma announced a co-promotion agreement with PhotoMedex for Metvixia under which Galderma
is providing marketing support and distribution. PhotoMedex sales force is promoting Metvixia and
Galdermas Aktilite lamp to healthcare professionals throughout the United States. While we are
entitled to royalties on net sales of Metvixia, Galderma and PhotoMedex together have considerably
more resources than we have, which could adversely affect our ability to maintain or increase our
market share.
While we attempt to protect our proprietary information as trade secrets through agreements
with each employee, licensing partner, consultant, university, pharmaceutical company and agent, we
cannot guarantee that these agreements will provide effective protection for our proprietary
information. It is possible that all of the following issues could negatively impact our ability to
be profitable:
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these persons or entities might breach the agreements, |
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we might not have adequate remedies for a breach, and/or, |
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our competitors will independently develop or otherwise discover our trade secrets. |
Litigation Is Expensive And We May Not Be Able To Afford The Costs.
The costs of litigation or any proceeding relating to our intellectual property or contractual
rights could be substantial even if resolved in our favor. Some of our competitors have far greater
resources than we do and may be better able to afford the costs of complex litigation. Also, in a
lawsuit against a third party for infringement of our patents in the United States, that third
party may challenge the validity of our patent(s). We cannot guarantee that a third party will not
claim, with or without merit, that our patents are not valid or that we have infringed their
patent(s) or misappropriated their proprietary material. We could get drawn into or decide to join,
litigation as the holder of the patent. Defending these types of legal actions involve considerable
expense and could negatively affect our financial results.
Additionally, if a third-party were to file a United States patent application, or be issued a
patent claiming technology also claimed by us in a pending United States application(s), we may be
required to participate in interference proceedings in the USPTO to determine the priority of the
invention. A third party could also request the declaration of a patent interference between one of
our issued United States patents and one of its patent applications. Any interference proceedings
likely would require participation by us and/or PARTEQ, which could involve substantial legal fees
and result in a loss or lessening of our patent protection.
Since We Now Operate The Only FDA Approved Manufacturing Facility For The Kerastick® And
Continue To Rely Heavily On Sole Suppliers For The Manufacture Of Levulan®, The
BLU-U®, ClindaReach®, And Meted®, Any Supply Or Manufacturing
Problems Could Negatively Impact Our Sales .
If we experience problems producing Levulan® Kerastick® units in our
facility, or if any of our contract suppliers fail to supply our requirements for products or
services, our business, financial condition and results of operations would suffer. Although we
have received approval by the FDA to manufacture the BLU-U® and the Levulan®
Kerastick® in our Wilmington, Massachusetts facility, at this time, with respect to the
BLU-U®, we expect to utilize our own facility only as a back-up to our current third
party manufacturer or for repairs.
Manufacturers and their subcontractors often encounter difficulties when commercial quantities of
products are manufactured for the first time, or large quantities of products are manufactured,
including problems involving:
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product yields, |
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quality control, |
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component and service availability, |
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compliance with FDA regulations, and |
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the need for further FDA approval if manufacturers make material changes to manufacturing processes
and/or facilities. |
We cannot guarantee that problems will not arise with production yields, costs or quality as
we and our suppliers manufacture our products. Any manufacturing problems could delay or limit our
supplies which would hinder our marketing and sales efforts. If our facility, any facility of our
contract manufacturers, or any equipment in those facilities is damaged or destroyed, we may not be
able to quickly or inexpensively replace it. Likewise, if there is quality or supply problems with
any components or materials needed to manufacturer our products, we may not be able to quickly
remedy the problem(s). Any of these problems could cause our sales to suffer and could increase
costs.
We Have Only Limited Experience Marketing And Selling Pharmaceutical Products Outside of the United
States And As A Result, Our Revenues From Product Sales May Suffer.
If we are unable to successfully market and sell sufficient quantities of our products,
revenues from product sales will be lower than anticipated and our financial condition may be
adversely affected. We are responsible for marketing our products in the United States and the rest
of the world, except Canada, Latin America and parts of Asia, where we have distributors. We
terminated our agreement with Stiefel, our former distributor in Latin America, on September 30,
2010. If our sales and marketing efforts fail, then sales of the Levulan®
Kerastick®, the BLU-U®, and other products will be adversely affected, which
would adversely affect our results of operations and financial condition.
The Commercial Success Of Any Product That We May Develop Will Depend Upon The Degree Of Market
Acceptance Of Our Products Among Physicians, Patients, Health Care Payors, Private Health Insurers
And The Medical Community.
Our ability to commercialize any product that we may develop will be highly dependent upon the
extent to which the product gains market acceptance among physicians, patients, health care payors,
such as Medicare and Medicaid, private health insurers, including managed care organizations and
group purchasing organizations, and the medical community. If a product does not achieve an
adequate level of acceptance, we may not generate material product revenues, and we may not become
profitable. The degree of market acceptance of our currently marketed products will depend on a
number of factors, including:
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the effectiveness, or perceived effectiveness, of our product in comparison to competing products, |
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the existence of any significant side effects, as well as their severity in comparison to any competing products, |
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potential advantages over alternative treatments, |
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the ability to offer our product for sale at competitive prices, |
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relative convenience and ease of administration, |
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the strength of marketing and distribution support, and |
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sufficient third-party coverage or reimbursement. |
If We Cannot Improve Physician Reimbursement And/Or Convince More Private Insurance Carriers To
Adequately Reimburse Physicians For Our Product, Sales May Suffer.
Without adequate levels of reimbursement by government health care programs and private health
insurers, the market for our Levulan® Kerastick® for AK therapy will be limited. While
we continue to support efforts to improve reimbursement levels to physicians and are working with
the major private insurance carriers to improve coverage for our therapy, if our efforts are not
successful, broader adoption of our therapy and sales of our products could be negatively impacted.
Although positive reimbursement changes related to AK were made over the last five years, some
physicians still believe that reimbursement levels do not fully reflect the required efforts to
routinely execute our therapy in their practices.
7
If insurance companies do not cover our products, reduce the amounts of coverage or stop
covering our products which are covered, our sales could be dramatically reduced.
We Have Only Three Therapies That Have Received Regulatory Approval Or Clearance, And We Cannot
Predict Whether We Will Ever Develop Or Commercialize Any Other Levulan® Products.
Our Potential Products Are In Early Stages Of Development And May Never Result In Any Additional
Commercially Successful Products.
Except for Levulan® PDT for AKs, the BLU-U® for acne, the
ClindaReach® pledget and other products we acquired in our merger with Sirius, all of
our other potential product candidates are being studied by independent investigators, or are at a
very early stage of development and subject to the risks of failure inherent in the development of
new pharmaceutical products and products based on new technologies. These risks include:
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delays in product development, clinical testing or manufacturing, |
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unplanned expenditures in product development, clinical testing or manufacturing, |
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failure in clinical trials or failure to receive regulatory approvals, |
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emergence of superior or equivalent products, |
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inability to market products due to third-party proprietary rights, and |
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failure to achieve market acceptance. |
We cannot predict how long the development of our investigational stage products will take or
whether they will be medically effective. We cannot be sure that a successful market will continue
to develop for our Levulan® drug technology.
We Must Receive Separate Approval For Any Drug or Medical Device Products Before We Can Sell Them
Commercially In The United States Or Abroad.
Any potential Levulan® product will require the approval of the FDA before it can
be marketed in the United States. Before an application to the FDA seeking approval to market a new
drug, called an NDA, can be filed, a product must undergo, among other things, extensive animal
testing and human clinical trials. The process of obtaining FDA approvals can be lengthy, costly,
and time-consuming. Following the acceptance of an NDA, the time required for regulatory approval
can vary and is usually one to three years or more. The FDA may require additional animal studies
and/or human clinical trials before granting approval. Our Levulan® PDT products are
based on relatively new technology. To our knowledge, the FDA has approved only four drugs for use
in photodynamic therapy, including Levulan® . This factor may lengthen the approval
process. We face much trial and error and we may fail at numerous stages along the way.
We cannot predict whether we will obtain any other regulatory approvals. Data obtained from
preclinical testing and clinical trials can be susceptible to varying interpretations which could
delay, limit or prevent regulatory approvals. Future clinical trials may not show that
Levulan® PDT is safe and effective for any new use we may study. In addition, delays or
disapprovals may be encountered based upon additional governmental regulation resulting from future
legislation or administrative action or changes in FDA policy.
Because Of The Nature Of Our Business, The Loss Of Key Members Of Our Management Team Could Delay
Achievement Of Our Goals.
We are a small company with only 89 employees, including 2 part-time employees, as of
September 30, 2010. We are highly dependent on several key officer/employees with specialized
scientific and technical skills
without whom our business, financial condition and results of operations would suffer, especially
in the photodynamic therapy portion of our business. The photodynamic therapy industry is still
quite small and the number of experts is limited. The loss of these key employees could cause
significant delays in achievement of our business and research goals since very few people with
their expertise could be hired. Our growth and future success will depend, in large part, on the
continued contributions of these key individuals as well as our ability to motivate and retain
other qualified personnel in our specialty drug and light device areas.
8
Collaborations With Outside Scientists May Be Subject To Restriction And Change.
We work with scientific and clinical advisors and collaborators at academic and other
institutions that assist us in our research and development efforts. These scientists and advisors
are not our employees and may have other commitments that limit their availability to us. Although
our advisors and collaborators generally agree not to do competing work, if a conflict of interest
between their work for us and their work for another entity arises, we may lose their services. In
addition, although our advisors and collaborators sign agreements not to disclose our confidential
information, it is possible that valuable proprietary knowledge may become publicly known through
them.
Risks Related To Our Industry
Product Liability And Other Claims Against Us May Reduce Demand For Our Products Or Result In
Damages.
We Are Subject To Risk From Potential Product Liability Lawsuits Which Could Negatively Affect Our
Business.
The development, manufacture and sale of medical products expose us to product liability
claims related to the use or misuse of our products. Product liability claims can be expensive to
defend and may result in significant judgments against us. A successful claim could materially harm
our business, financial condition and results of operations. Additionally, we cannot guarantee that
continued product liability insurance coverage will be available in the future at acceptable costs.
If we believe the cost of coverage is too high, we may self-insure.
Our Business Involves Environmental Risks And We May Incur Significant Costs Complying With
Environmental Laws And Regulations.
We have used various hazardous materials, such as mercury in fluorescent tubes in our research
and development activities. We are subject to federal, state and local laws and regulations which
govern the use, manufacture, storage, handling and disposal of hazardous materials and specific
waste products. We believe that we are in compliance in all material respects with currently
applicable environmental laws and regulations. However, we cannot guarantee that we will not incur
significant costs to comply with environmental laws and regulations in the future. We also cannot
guarantee that current or future environmental laws or regulations will not materially adversely
affect our operations, business or financial condition. In addition, although we believe our safety
procedures for handling and disposing of these materials comply with federal, state and local laws
and regulations, we cannot completely eliminate the risk of accidental contamination or injury from
these materials. In the event of such an accident, we could be held liable for any resulting
damages, and this liability could exceed our resources.
We May Not Be Able To Compete Against Traditional Treatment Methods Or Keep Up With Rapid Changes
In The Biotechnology And Pharmaceutical Industries That Could Make Some Or All Of Our Products
Non-Competitive Or Obsolete.
Competing Products And Technologies Based On Traditional Treatment Methods May Make Our Products Or
Potential Products Noncompetitive Or Obsolete.
Well-known pharmaceutical, biotechnology and medical device companies are marketing
well-established therapies for the treatment of AKs and acne. Doctors may prefer to use familiar
methods, rather than trying our products. Reimbursement issues affect the economic competitiveness
of our products as compared to other more traditional therapies.
Many companies are also seeking to develop new products and technologies, and receiving
approval for treatment of AKs and acne. Our industry is subject to rapid, unpredictable and
significant technological change. Competition is intense. Our competitors may succeed in developing
products that are safer, more effective or more desirable than ours. Many of our competitors have
substantially greater financial, technical and marketing resources than we have. In addition,
several of these companies have significantly greater experience than we do in developing products,
conducting preclinical and clinical testing and obtaining regulatory approvals to market products
for health care.
We cannot guarantee that new drugs or future developments in drug technologies will not have a
material adverse effect on our business. Increased competition could result in:
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price reductions, |
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lower levels of third-party reimbursements, |
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failure to achieve market acceptance, and |
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loss of market share, |
any of which could adversely affect our business, results of operations and financial condition.
Further, we cannot give any assurance that developments by our competitors or future
competitors will not render our technology obsolete or less advantageous.
On May 30, 2006, we entered into a patent license agreement with Photocure ASA whereby we
granted a non-exclusive license to Photocure under the patents we license from PARTEQ, for esters
of ALA. Furthermore, we granted a non-exclusive license to Photocure for its existing formulations
of its Hexvix® and Metvix® (known in the United States as
Metvixia® ) products for any of our patents that may issue or be licensed by us in the
future. Photocure received FDA approval to market Metvixia® for treatment of AKs in July
2004, and this product, which is directly competitive with our Levulan®
Kerastick® product, is commercially available and its price is comparable to the price
of Levulan®. On October 1, 2009, Photocure announced that it had sold Metvix/Metvixia to
Galderma, S.A., a large dermatology company. On January 11, 2010, Galderma announced a co-promotion
agreement with PhotoMedex for Metvixia under which Galderma is providing marketing support and
distribution. PhotoMedex sales force is promoting Metvixia and Galdermas Aktilite lamp to
healthcare professionals throughout the United States. While we are entitled to royalties on net
sales of Metvixia, Galderma and PhotoMedex together have considerably more resources than we have,
which could significantly hamper our ability to maintain or increase our market share.
Our Competitors In The Biotechnology And Pharmaceutical Industries May Have Better Products,
Manufacturing Capabilities Or Marketing Expertise.
We are aware of several companies commercializing and/or conducting research with ALA or
ALA-related compounds, including: Galderma/PhotoMedex, medac GmbH and photonamic GmbH & Co. KG
(Germany); Biofrontera, PhotoTherapeutics, Inc. (U.K.), and Photocure ASA (Norway). We also
anticipate that we will face increased competition as the scientific development of PDT advances
and new companies enter our markets. Several companies are developing PDT agents other than
Levulan® . These include: QLT Inc. (Canada); Axcan Pharma Inc. (U.S.); Miravant, Inc.
(U.S.); and Pharmacyclics, Inc. (U.S.). There are many pharmaceutical companies that compete with
us in the field of dermatology, particularly in the acne market.
We expect that our principal methods of competition with other PDT products will be based upon such
factors as:
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the ease of administration of our method of PDT, |
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the degree of generalized skin sensitivity to light, |
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the number of required doses, |
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the selectivity of our drug for the target lesion or tissue of interest, and |
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the type and cost of our light systems. |
Our primary competition in the acne market includes oral and topical antibiotics, other
topical prescription and over-the-counter products, as well as various laser and non-laser light
treatments. The market is highly competitive and other large and small companies have more
experience than we do which could make it difficult for us to penetrate the market. The entry of
new products from time to time would likely cause us to lose market share.
Risks Related To Our Stock
Our Common Stock May Not Continue To Trade On The Nasdaq Global Market, Which Could Reduce The
Value Of Your Investment And Make Your Shares More Difficult To Sell.
In order for our common stock to trade on the Nasdaq Global Market, we must continue to meet
the listing standards of that market. Among other things, those standards require that our common
stock maintain a minimum closing bid price of at least $1.00 per share. During 2009, our common
stock traded at prices near and below $1.00. If we do not continue to meet Nasdaqs applicable
minimum listing standards, Nasdaq could delist us from the
10
Nasdaq Global Market. If our common
stock is delisted from the Nasdaq Global Market, we could seek to have our common stock listed on
the Nasdaq Capital Market or other Nasdaq markets. However, delisting of our common stock from the
Nasdaq Global Market could hinder your ability to sell, or obtain an accurate quotation for the
price of, your shares of our common stock. Delisting could also adversely affect the perception
among investors of DUSA and its prospects, which could lead to further declines in the market price
of our common stock. Delisting may also make it more difficult and expensive for us to raise
capital. In addition, delisting might subject us to a Securities and Exchange Commission rule that
could adversely affect the ability of broker-dealers to sell or make a market in our common stock,
thus hindering your ability to sell your shares.
Our Stock Price Is Highly Volatile And Sudden Changes In The Market Value Of Our Stock Occur Making
An Investment Risky.
The price of our common stock has been highly volatile, which may create an increase in the
risk of capital losses for our shareholders. From January 1, 2008 to September 30, 2010, the price
of our stock has ranged from a low of $0.87 to a high of $2.75. The significant general market
volatility in similar stage pharmaceutical and biotechnology companies also made the market price
of our stock volatile.
Significant Fluctuations In Orders For Our Products, On A Monthly And Quarterly Basis, Are Common
Based On External Factors And Sales Promotion Activities. These Fluctuations Could Increase The
Volatility Of Our Stock Price.
The price of our common stock may be affected by the amount of quarterly shipments of our
products to end-users. Since our PDT products are still in relatively early stages of adoption, and
sales volumes are still low, a number of factors could affect product sales levels and growth rates
in any period. These could include the level of penetration of new markets outside of the United
States, the timing of medical conferences, sales promotion activities, and large volume purchases
by our higher usage customers. In addition, seasonal fluctuations in the number of patients seeking
treatment at various times during the year could impact sales volumes. These factors could, in
turn, affect the volatility of our stock price.
Future Sales Of Securities May Cause Our Stock Price To Decline.
As of September 30, 2010, there were outstanding options and warrants to purchase 4,568,000
shares of common stock, with exercise prices ranging from $1.08 to $27.31 per share for options,
and exercise prices ranging from $2.85 to $6.00 per share for warrants. In addition, there were
586,000 shares of unvested common stock. The holders of the options and warrants have the
opportunity to profit if the market price for the common stock exceeds the exercise price of their
respective securities, without assuming the risk of ownership. Also, if some or all of such shares
are sold into the public market over a short period of time, the value of all publicly traded
shares could decline, as the market may not be able to absorb those shares at then-current market
prices. Additionally, such sales may make it more difficult for us to sell equity securities or
equity-related securities in the future at a time and price that our management deems acceptable,
or at all. The holders may exercise their securities during a time when we would likely be able to
raise capital from the public on terms more favorable than those provided in these securities.
Effecting A Change Of Control Of DUSA Would Be Difficult, Which May Discourage Offers For Shares Of
Our Common Stock.
Our certificate of incorporation authorizes the board of directors to issue up to 100,000,000
shares of stock, 40,000,000 of which are common stock. The board of directors has the authority to
determine the price, rights, preferences and privileges, including voting rights, of the remaining
60,000,000 shares without any further vote or action by the shareholders. The rights of the holders
of our common stock will be subject to, and may be adversely affected by, the rights of the holders
of any preferred stock that may be issued in the future.
On September 27, 2002, we adopted a shareholder rights plan at a special meeting of our board
of directors. The rights plan could discourage, delay or prevent a person or group from acquiring
15% or more of our common
stock, thereby limiting, perhaps, the ability of certain of our shareholders to benefit from such a
transaction.
The rights plan provides for the distribution of one right as a dividend for each outstanding
share of our common stock to holders of record as of October 10, 2002. Each right entitles the
registered holder to purchase one one-thousandths of a share of preferred stock at an exercise
price of $37.00 per right. The rights will be exercisable subsequent to the date that a person or
group either has acquired, obtained the right to acquire, or commences or discloses an intention to
commence a tender offer to acquire, 15% or more of our outstanding common stock or if a person or
group is declared an Adverse Person, as such term is defined in the rights plan. The rights may
be redeemed by us at a redemption price of one one-hundredth of a cent per right until ten days
following the date the
11
person or group acquires, or discloses an intention to acquire, 15% or more,
as the case may be, of DUSA, or until such later date as may be determined by our board of
directors.
Under the rights plan, if a person or group acquires the threshold amount of common stock, all
holders of rights (other than the acquiring person or group) may, upon payment of the purchase
price then in effect, purchase shares of common stock of DUSA having a value of twice the purchase
price. In the event that we are involved in a merger or other similar transaction where we are not
the surviving corporation, all holders of rights (other than the acquiring person or group) shall
be entitled, upon payment of the purchase price then in effect, to purchase common stock of the
surviving corporation having a value of twice the purchase price. The rights will expire on October
10, 2012, unless previously redeemed. Our board of directors has also adopted certain amendments to
our certificate of incorporation consistent with the terms of the rights plan.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus includes or incorporates forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
as amended. All statements, other than statements of historical facts, included or incorporated in
this prospectus regarding our strategy, future operations, financial position, future revenues,
projected costs, prospects, plans and objectives of management are forward-looking statements. The
words anticipates, believes, estimates, expects, intends, may, plans, projects,
will, would and similar expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying words. We cannot guarantee
that we actually will achieve the plans, intentions or expectations disclosed in our
forward-looking statements and you should not place undue reliance on our forward-looking
statements. Actual results or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we make. We have included important
factors in the cautionary statements included or incorporated in this prospectus, particularly
under the heading Risk Factors, that we believe could cause actual results or events to differ
materially from the forward-looking statements that we make. Our forward-looking statements do not
reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or
investments we may make. We do not assume any obligation to update any forward-looking statements.
You should not unduly rely on forward-looking statements contained or incorporated by
reference in this prospectus. Actual results or outcomes may differ materially from those
predicted in our forward-looking statements due to the risks and uncertainties inherent in our
business, including among other items, beliefs regarding the ability for suppliers to meet our
future requirements or provide us with favorable terms, beliefs regarding potential reduction of
headcount, beliefs regarding an interruption in the supply of products or parts or any significant
price increase by sole source suppliers, expectations regarding the enrollment of patients into and
timing of results of clinical trials, beliefs regarding sales on non-reimbursed procedures and
softness in the international markets, expectations concerning manufacture of the BLU-U® in our
facility, intention to pursue licensing, marketing, co-promotion, other arrangements, additional
business or new technologies, beliefs regarding the status of clinical programs and beliefs
regarding potential efficacy, expectations regarding collection of payments from the License
Agreement with Rivers Edge, beliefs regarding the transfer to a new laboratory for analytical
testing of our Levulan® Kerastick® product and potential impact on revenues, beliefs concerning
achievement of higher margins on Kerastick sales and BLU-U® sales at low margins, beliefs regarding
the impact on our market share of the promotion of Metvixia, expectations to reduce spending if we
are unable to achieve profitability, expectations regarding the confidentiality of our proprietary
information, expectations to raise funds through financing transactions and whether such financing
will be available or at reasonable
terms, beliefs regarding regulatory and environmental compliance and impact of failures in
compliance, beliefs concerning patent disputes, expectations regarding the reexamination process of
our patents, beliefs regarding the impact of litigation and ability to afford the costs, ability
and intentions to defend and enforce our patents, the impact of a third-partys regulatory
compliance status and fulfillment of contractual obligations, expectations of increases or
decreases in the prices we charge for our products, our beliefs regarding the size of the market
for our products and our product candidate, expected use and sufficiency of cash resources, beliefs
regarding requirements of cash resources for our future liquidity,
12
and research and development
programs, beliefs regarding investments and economic conditions including the impact of our
customers failure to meet our payment or supply terms, expectations regarding outstanding options
and warrants and our dividend policy, anticipation of increases or decreases in personnel, beliefs
regarding the effect of reimbursement policies on revenues and acceptance of our therapies,
expectations for future strategic opportunities and research and development programs and expenses,
expectations for continuing operating losses and competition, expectations regarding the adequacy
and availability of insurance, expectations regarding general and administrative costs,
expectations regarding sales and marketing costs and research and development costs, levels of
interest income and our capital resource needs, the potential for additional inspection and testing
of our manufacturing facilities or additional FDA actions, beliefs regarding interest rate risks to
our investments and effects of inflation, beliefs regarding the impact of any current or future
legal proceedings, beliefs regarding dependence on key personnel, beliefs concerning product
liability insurance, beliefs regarding the enforceability of our patents, beliefs regarding the
entry into the market and impact of generic products on revenues, financial condition, results of
operations and profitability, beliefs regarding our sales and marketing efforts, beliefs regarding
competition with other companies and effect of increased reimbursement, beliefs regarding the
adoption of our products, expectations regarding additional milestone payments with respect to the
Sirius merger, beliefs regarding the use of our products and technologies by third parties, beliefs
regarding our compliance with applicable laws, rules and regulations, beliefs regarding available
reimbursement for our products, beliefs regarding the current and future clinical development and
testing of our potential products and technologies and the costs thereof, beliefs regarding the
volatility of our stock price, beliefs regarding the impact of our rights plan, beliefs regarding
the impact of future sales of securities, beliefs regarding the valuation of warrants, expectations
related to the change in revenues of our PDT and Non-PDT products, expectations regarding the
payment of remaining milestones to former Sirius shareholders, beliefs regarding market share and
market penetration, beliefs regarding obtaining and sustaining profitability, expectations
regarding the change in growth in our PDT Drug and Device Products segment, expectations regarding
our manufacturing facility, beliefs regarding our SOTR research and development program, beliefs
regarding Nasdaq listing, beliefs regarding Section 382 on our current and future NOLs, beliefs
regarding unknown problems with the product, a manufacturer or its facility in the future, beliefs
regarding financial position, results of operations and cash flows if needed capital is not raised,
beliefs regarding our ability to use net operating loss carryforwards and tax credit carryforwards
to offset future taxable income, beliefs regarding a future ownership change, beliefs regarding the
outcome if some or all of our shares are sold into the public market over a short period of time,
beliefs regarding our ability to sell equity securities or equity-related securities in the future,
beliefs regarding our expectation and ability to obtain funds through other public or private
financings, including equity financing, and/or through collaborative arrangements and its effect on
our existing shareholders, beliefs regarding the impact that any manufacturing or supply problems
could have on our sales and on our financial condition, beliefs regarding the scope of our patents,
beliefs regarding competition from other ALA products, beliefs concerning safety procedures for
hazardous materials, our compliance and risks of liability, expectations regarding the manufacture
of our products, beliefs regarding collaborations with outside scientists, expectations regarding
revenues from Nicomide®, and expectations regarding royalty payments.
These forward-looking statements are further qualified by important factors that could cause
actual results to differ materially from those in the forward-looking statements. These factors
include, without limitation, changing market and regulatory conditions, actual clinical results of
our trials, the impact of competitive products and pricing, the timely development, FDA and foreign
regulatory
approval, and market acceptance of our products, environmental risks relating to our products,
reliance on third-parties for the production, manufacture, sales and marketing of our products, the
availability of products for acquisition and/or license on terms agreeable to us, sufficient
sources of funds, the securities regulatory process, the maintenance of our patent portfolio and
ability to obtain competitive levels of reimbursement by third-party payors, none of which can be
assured. Results actually achieved may differ materially from expected results included in these
statements as a result of these or other factors.
You should read and interpret any forward-looking statements together with the following documents:
13
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our most recent Annual Report on Form 10-K; |
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our most recent Quarterly Report on Form 10-Q; |
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our most recent Current Reports on Form 8-K; |
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the risk factors contained in this prospectus under the caption Risk Factors; and |
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our other filings with the SEC. |
Any forward-looking statement speaks only as of the date on which that statement is made. We
will not update any forward-looking statement to reflect events or circumstances that occur after
the date on which such statement is made.
USE OF PROCEEDS
DUSA will not receive any proceeds from the sale of shares of common stock which may be sold
pursuant to this prospectus for the respective accounts of the selling securityholders. All such
proceeds, net of brokerage commissions, if any, will be received by the selling securityholders.
See the sections titled Selling Securityholders and Plan of Distribution.
SELLING SECURITYHOLDERS
This prospectus relates to shares of common stock to be offered by the selling
securityholders. The table below, including the footnotes, presents information regarding the
selling securityholders and the shares of our common stock that the selling securityholders may
offer and sell from time to time under this prospectus. The inclusion in the table of the
individuals named therein shall not be deemed to be an admission that any such individuals are
affiliates of DUSA.
The following is a list, as of September 30, 2010, of the selling securityholders and the
number of shares beneficially owned by each selling securityholder. The number of shares in the
column Number of Shares Owned represents the total number of shares that a selling security
holder currently owns or has the right to acquire within sixty (60) days of September 30, 2010.
The number of shares in the columns Number of Shares to be Offered represent all of the shares
that a selling securityholder may offer under this prospectus. The table and footnotes assume that
the selling securityholders will sell all of such shares. However, because the selling
securityholders may sell all or some of their shares under this prospectus from time to time, or in
another permitted manner, we cannot assure you as to the actual number of shares that will be sold
by the selling securityholders or that will be held by the selling securityholders after completion
of any sales. We do not know how long the selling securityholders will hold the shares before
selling them. Information concerning the selling securityholders may change from time to time and
changed information will be presented in a supplement to this prospectus if and when necessary and
required. Beneficial ownership is determined in accordance with Rule 13d-3(d) promulgated by the
SEC under the Securities Exchange Act of 1934, as amended.
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Number of |
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Number of |
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Number of |
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Name |
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Owned |
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Offered(1)
(2) |
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After Offering |
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After Offering |
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Alfred Altomari (3) |
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17,000 |
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15,000 |
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2,000 |
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David M. Bartash (4) |
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122,375 |
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106,875 |
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15,500 |
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* |
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Alexander W. Casdin (5) |
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235,000 |
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35,000 |
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200,000 |
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* |
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Jay M. Haft (6) |
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143,250 |
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98,750 |
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44,500 |
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* |
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Paul J. Hondros (7) |
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15,000 |
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15,000 |
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0 |
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* |
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Magnus Moliteus (8) |
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86,875 |
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71,875 |
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15,000 |
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* |
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David M. Wurzer (9) |
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20,000 |
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15,000 |
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5,000 |
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* |
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(1) |
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Represents shares beneficially owned by the named individual which have been granted under
the DUSA Pharmaceuticals, Inc. 1996 Omnibus Plan, as amended, and the DUSA Pharmaceuticals,
Inc. 2006 Equity Compensation Plan, as amended, including shares that such individual has the
right to acquire upon exercise of options vesting within sixty (60) days of September 30,
2010, but does not include shares underlying options which vest more than sixty (60) days from
such date. Also includes all shares previously issued to such individuals after the exercise
of options granted under the listed plans and shares of common stock otherwise acquired, or
beneficially owned, by such named individual. Unless otherwise noted, all persons referred to
above have sole voting and sole investment power. |
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Does not constitute a commitment to sell any or all of the stated number of shares of common
stock. The number of shares offered shall be determined from time to time by each selling
securityholder at their sole discretion. |
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Mr. Altomari has served as a director since July 2010. Beneficial ownership includes 2,000
shares of common stock and 15,000 shares of common stock underlying stock options granted to
Mr. Altomari which have vested as of September 30, 2010. |
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(4) |
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Mr. Bartash has served as a director since November 2001. Beneficial ownership includes
15,500 shares of common stock, 1,875 shares of restricted stock awards which have vested as of
September 30, 2010 and 105,000 shares of common stock underlying stock options granted to Mr.
Bartash which have vested as of September 30, 2010. |
|
(5) |
|
Mr. Casdin has served as a director since January 2009. Beneficial ownership includes 200,000
shares of common stock and 35,000 shares of common stock underlying stock options granted to
Mr. Casdin which have vested as of September 30, 2010. |
|
(6) |
|
Mr. Haft has served as the Chairman of the Board of Directors since December 2008. He has
served as a director since September 1996 and has also served as Chairman of the Board from
June 2003 to December 2004 and as Vice Chairman of the Board and Lead Director from December
2004 to December 2008. Beneficial ownership includes 44,500 shares of common stock, 3,750
shares of restricted stock awards which have vested as of September 30, 2010 and 95,000 shares
of common stock underlying stock options granted to Mr. Haft which have vested as of September
30, 2010. Under Rule 13d-3 of the Securities and Exchange Act of 1934, as amended, Mr. Haft
disclaims, but may be deemed to be the beneficial owner of, 34,500 shares of common stock held
indirectly by Mr. Hafts spouse. |
|
(7) |
|
Mr. Hondros has served as a director since July 2010. Beneficial ownership includes 15,000 shares of common stock underlying stock options granted to Mr. Hondros which have vested as of September 30, 2010. |
|
(8) |
|
Mr. Moliteus has served as a director since August 2003. Beneficial ownership includes 15,000
shares of common stock, 1,875 shares of restricted stock awards which have vested as of
September 30, 2010 and 70,000 shares of common stock underlying stock options granted to Mr.
Moliteus which have vested as of September 30, 2010. |
|
(9) |
|
Mr. Wurzer has served as a director since July 2010. Beneficial ownership includes 5,000
shares of common stock and 15,000 shares of common stock underlying stock options granted to
Mr. Wurzer which have vested as of September 30, 2010. |
15
PLAN OF DISTRIBUTION
Shares offered hereby may be sold from time to time directly by or on behalf of the selling
securityholders in one or more transactions on the Nasdaq Global Market or on any stock exchange on
which the common stock may be listed at the time of sale, in privately negotiated transactions, or
through a combination of such methods, at market prices prevailing at the time of sale, at prices
related to such prevailing market prices, at fixed prices (which may be changed) or at negotiated
prices. The selling securityholders may sell shares through one or more agents, brokers or dealers
or directly to purchasers. Such brokers or dealers may receive compensation in the form of
commissions, discounts or concessions from the selling securityholders and/or purchasers of the
shares or both (which compensation as to a particular broker or dealer may be in excess of
customary commissions).
In connection with such sales, the selling securityholders and any participating broker or
dealer may be deemed to be underwriters within the meaning of the Securities Act, and any
commissions they receive and the proceeds of any sale of shares may be deemed to be underwriting
discounts and commissions under the Securities Act.
In order to comply with certain state securities laws, if applicable, the shares may be sold
in such jurisdictions only through registered or licensed brokers or dealers. In certain states,
the shares may not be sold unless the shares have been registered or qualified for sale in such
state or an exemption from regulation or qualification is available and is complied with. Sales of
shares must also be made by the selling securityholders in compliance with all other applicable
state securities laws and regulations.
In addition to any shares sold hereunder, selling securityholders may, at the same time, sell
any shares of common stock owned by them in compliance with all of the requirements of Rule 144,
regardless of whether such shares are covered by this reoffer prospectus. There can be no
assurance that any of the selling securityholders will sell any or all of the shares offered by
them hereby.
DUSA will pay all expenses of the registration of the shares. DUSA has notified certain
selling securityholders of the need to deliver a copy of this reoffer prospectus in connection with
any sale of the shares.
LEGAL MATTERS
The
validity of the shares being offered hereby has been passed upon for DUSA by Reed Smith LLP. Nanette W. Mantell, Esq., a partner of Reed Smith LLP, serves as DUSAs Secretary, which is
an officer position.
EXPERTS
The consolidated financial statements, incorporated in this prospectus by reference from DUSA
Pharmaceuticals, Inc.s Annual Report on Form 10-K for the year ended December 31, 2009, have been
audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated
in their report, which is incorporated herein by reference. Such financial statements have 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 with the SEC a registration statement on Form S-8 under the Securities Act with
respect to the shares of common stock offered hereby. This prospectus does not contain all of the
information set forth in the registration statement and the exhibits thereto. You can find
additional information regarding us and the common stock in the registration statement and the
exhibits. Statements
16
contained in this prospectus regarding the contents of any contract or any
other document to which reference is made are not necessarily complete, and, in each instance where
a copy of such contract or other document has been filed as an exhibit to the registration
statement, reference is made to the copy so filed, each such statement being qualified in all
respects by such reference.
We are subject to the informational requirements of the Securities Exchange Act of 1934, as
amended (the Exchange Act), and, in accordance therewith, file reports and other information with
the SEC. The registration statement, including exhibits, and the reports and other information
filed by us can be inspected without charge at the public reference facilities maintained by the
SEC at the SECs public reference room at 100 F Street, N.E., Washington, D.C. 20549. Copies of
such material can be obtained from such offices at fees prescribed by the SEC. The public may
obtain information on the operation of the Public Reference room by calling the SEC at
1-800-SEC-0330. The SEC maintains a World Wide Web site that contains reports, proxy and
information statements and other information regarding registrants that file electronically with
the SEC. The address of this site is http://www.sec.gov. In addition, you can also access
documents we file with the SEC at our website, http://www.dusapharma.com, which is not a part of
this prospectus and is not incorporated herein by reference.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents, which have been filed by us with the SEC pursuant to the Exchange
Act, are incorporated by reference in this prospectus as of their respective dates:
|
(a) |
|
Our Annual Report on Form 10-K and Form 10-K/A for the year ended December 31,
2009; |
|
|
(b) |
|
Our Quarterly Report on Form 10-Q for the quarters ended March 31, 2010, June
30, 2010 and September 30, 2010; |
|
|
(c) |
|
Our Schedule 14A filed with the SEC on June 17, 2010; |
|
|
(d) |
|
Our Current Report on Form 8-K filed with the SEC on May 10, 2010, May 13,
2010, June 4, 2010, June 24, 2010, August 2, 2010, August 6, 2010 and October 6, 2010; |
|
|
(e) |
|
All other reports filed pursuant to Section 13 or 15(d) of the Exchange Act
since December 31, 2009; and |
|
|
(f) |
|
The description of DUSAs common stock contained in its registration statement
on Form 8-A which was filed on January 3, 1992 and amended on Form 8-A filed on October
24, 1997, and in DUSAs Quarterly Report on Form 10-Q which was filed on November 12,
1997. |
All documents filed by us pursuant to Section 13(a), 13(c), 14 and 15(d) of the Exchange Act
after the date hereof and prior to the termination of the offering, other than information
furnished pursuant to Item 2.02 or Item 7.01 of Form 8-K or as otherwise permitted by SEC rules and
regulations, shall be deemed to
be incorporated by reference into this prospectus and to be a part hereof from the date of
filing of such documents. Any statement contained in a document incorporated or deemed to be
incorporated herein by reference shall be deemed to be modified or superseded for purposes of this
prospectus to the extent that a statement contained herein or in any other subsequently filed
document which also is or is deemed to be incorporated by reference herein modifies or supersedes
such statement.
We will provide without charge to any person, including any beneficial owner, to whom this
prospectus is delivered, upon written or oral request of such person, a copy of each document
incorporated by reference in the prospectus (other than exhibits to such documents unless such
exhibits are specifically incorporated by reference into this prospectus). We will provide such
copies at no cost, upon written or oral request, by writing or telephoning us at:
17
|
|
|
|
|
DUSA Pharmaceuticals, Inc.
25 Upton Drive
Wilmington, Massachusetts 01887
Attention: Mr. Richard Christopher
Telephone: (978) 657-7500
Attention: Mr. Richard Christopher
E-mail to: ChristopherR@DusaPharma.com |
Our World Wide Web site is located at www.dusapharma.com. Information on the Web site is
not incorporated by reference into this prospectus.
18
357,500 Shares
DUSA
PHARMACEUTICALS, INC.
Common Stock
PROSPECTUS
November , 2010
PART II
INFORMATION REQUIRED TO BE IN THE REGISTRATION STATEMENT
ITEM 3. Incorporation of Documents by Reference
The following documents, which have been filed by us with the SEC pursuant to the Exchange
Act, are incorporated by reference in this registration statement as of their respective dates:
|
(a) |
|
Our Annual Report on Form 10-K and Form 10-K/A for the year ended December 31,
2009; |
|
|
(b) |
|
Our Quarterly Report on Form 10-Q for the quarters ended March 31, 2010, June
30, 2010 and September 30, 2010; |
|
|
(c) |
|
Our Schedule 14A filed with the SEC on June 17, 2010; |
|
|
(d) |
|
Our Current Report on Form 8-K filed with the SEC on May 10, 2010, May 13,
2010, June 4, 2010, June 24, 2010, August 2, 2010, August 6, 2010 and October 6, 2010; |
|
|
(e) |
|
All other reports filed pursuant to Section 13 or 15(d) of the Exchange Act
since December 31, 2009; and |
|
|
(f) |
|
The description of DUSAs common stock contained in its registration statement
on Form 8-A which was filed on January 3, 1992 and amended on Form 8-A filed on October
24, 1997, and in DUSAs Quarterly Report on Form 10-Q which was filed on November 12,
1997. |
All documents filed by us pursuant to Section 13(a), 13(c), 14 and 15(d) of the Exchange Act
after the date hereof and prior to the termination of the offering, other than information
furnished pursuant to Item 2.02 or Item 7.01 of Form 8-K or as otherwise permitted by SEC rules and
regulations, shall be deemed to be incorporated by reference into this registration statement and
to be a part hereof from the date of filing of such documents. Any statement contained in a
document incorporated or deemed to be incorporated herein by reference shall be deemed to be
modified or superseded for purposes of this registration statement to the extent that a statement
contained herein or in any other subsequently filed document which also is or is deemed to be
incorporated by reference herein modifies or supersedes such statement.
ITEM 4. Description of Securities
Not applicable.
ITEM 5. Interests of Named Experts and Counsel
Not applicable.
ITEM 6. Indemnification of Directors and Officers
Article 5 of the Companys Certificate of Incorporation, as amended, and New Jersey Business
Corporation Act, N.J.S.A. 14A:2-7 provide as follows:
Any director and officer of the Corporation shall not be personally liable to the Corporation
or its shareholders for damages for breach of any duty owed to the Corporation or its shareholders,
except that this
II-1
provision shall not relieve a director or officer from liability for any breach of duty based
upon an act or omission (a) in breach of such persons duty of loyalty to the Corporation or its
shareholders; (b) not in good faith or involving a knowing violation of law; or (c) resulting in
receipt by such person of an improper personal benefit.
The Companys By-laws, as amended, pursuant to the New Jersey Business Corporation Act,
N.J.S.A. 14A:3-5, provide as follows:
ARTICLE IV
INDEMNIFICATION
Section 1. Actions by Others. The Corporation (1) shall indemnify any person
who was or is a party or is threatened to be made a party to any threatened, pending or completed
action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an
action by or in the right of the Corporation) by reason of the fact that he is or was a director,
officer or trustee of the Corporation or of any constituent corporation absorbed by the Corporation
in a consolidation or merger and (2) except as otherwise required by Section 3 of this Article, may
indemnify any person who was or is a party or is threatened to be made a party to any threatened,
pending or completed action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the Corporation) by reason of the fact
that he (a) is or was an employee or agent or the legal representative of a director, officer,
trustee, employee or agent of the Corporation or of any absorbed constituent corporation, or (b) is
or was serving at the request of the Corporation or of any absorbed constituent corporation as a
director, officer, employee, agent of or participant in another corporation, partnership, joint
venture, trust or other enterprise, or the legal representative of such a person against expenses,
costs, disbursements (including attorneys fees), judgments, fines and amounts actually and
reasonably incurred by him in good faith and in connection with such action, suit or proceeding if
he acted in a manner he reasonably believed to be in or not opposed to the best interests of the
Corporation, and with respect to any criminal action or proceeding, he had no reasonable cause to
believe that his conduct was unlawful. The termination of any action, suit or proceeding by
judgment, order, settlement, conviction, or upon a plea of nolo contendere or its
equivalent, shall not, of itself, create a presumption that the person did not meet the applicable
standard of conduct.
Section 2. Actions by or in the Right of the Corporation. The Corporation
shall indemnify any person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action or suit by or in the right of the Corporation to procure a
judgment in its favor by reason of the fact that he is or was a director, officer, trustee,
employee or agent of the Corporation or of any constituent corporation absorbed by the Corporation
by consolidation or merger, or the legal representative of any such person, or is or was serving at
the request of the Corporation or of any absorbed constituent corporation, as a director, officer,
trustee, employee, agent of or participant, or the legal representative of any such person in
another corporation, partnership, joint venture, trust or other enterprise against expenses
(including attorneys fees) actually and reasonably incurred by him in connection with the defense
or settlement of such action or suit if he acted in good faith and in a manner he reasonably
believed to be in or not opposed to the best interests of the Corporation and except that no
indemnification shall be made in respect of any claim, issue or matter as to which such person
shall have been adjudged to be liable to the Corporation unless and only to the extent that the New
Jersey Superior Court or the court in which such action or suit was brought shall determine upon
application that, despite the adjudication of liability but in view of all the circumstances of the
case, such person is fairly and reasonably entitled to indemnity for such expenses which the New
Jersey Superior Court or such other court shall deem proper.
Section 3. Successful Defense. To the extent that a person who is or was a
director, officer, trustee, employee or agent of the Corporation or of any constituent corporation
absorbed by the
II-2
Corporation by consolidation or merger, or the legal representative of any such person, has
been successful on the merits or otherwise in defense of any action, suit or proceeding referred to
in Section 1 or Section 2 of this Article, or in defense of any claim, issue, or matter therein, he
shall be indemnified against expenses (including attorneys fees) actually and reasonably incurred
by him in connection therewith.
Section 4. Specific Authorization. Any indemnification under Section 1 or
Section 2 of this Article (unless ordered by a court) shall be made by the Corporation only as
authorized in the specific case upon a determination that indemnification of the director, officer,
trustee, employee, agent, or the legal representative thereof, is proper in the circumstances
because he has met the applicable standard of conduct set forth in said Sections 1 and 2. Such
determination shall be made (1) by the Board of Directors by a majority vote of quorum consisting
of directors who were not parties to such action, suit or proceeding, or (2) if such a quorum is
not obtainable, a quorum of disinterested directors so directs, by independent legal counsel for a
written opinion, (3) by the shareholders.
Section 5. Advance of Expenses. Expenses incurred by any person who may have
a right of indemnification under this Article in defending civil or criminal action, suit or
proceeding may be paid by the Corporation in advance of the final distribution of such action, suit
or proceeding as authorized by the board of directors upon receipt of an undertaking by or on
behalf of the director, officer, trustee, employee, or the legal representative thereof, to repay
such amount unless it shall ultimately be determined that he is entitled to be indemnified by the
Corporation pursuant to this Article.
Section 6. Right of Indemnity not Exclusive. The indemnification and
advancement of expenses provided by this Article shall not exclude any other rights to which those
seeking indemnification may be entitled under the certificate of incorporation of the Corporation
or any by-law, agreement, vote of shareholders or otherwise; provided that no indemnification shall
be made to or on behalf of a Director, officer, trustee, employee, agent, or legal representative
if a judgment or other final adjudication adverse to such persons establishes that his acts or
omissions (a) were in breach of his duty of loyalty to the corporation or its shareholders, (b)
were not in good faith or involved a knowing violation of law or (c) resulted in receipt by such
person of an improper personal benefit.
Section 7. Insurance. The Corporation may purchase and maintain insurance on
behalf of any person who is or was a director, officer, trustee, employee or agent of the
Corporation or of any constituent corporation absorbed by the Corporation by consolidation or
merger of the legal representative of such person or is or was serving at the request of the
Corporation or of any absorbed constituent corporation as a director, officer, trustee, employee or
agent of or participant in another corporation, partnership, joint venture, trust or other
enterprise, or the legal representative of any such person against any liability asserted against
him and incurred by him in any such capacity, arising out of his status as such or by reason of his
being or having been such, whether or not the Corporation would have the power to indemnify him
against such liability under the provisions of this Article, the New Jersey Business Corporation
Act, or otherwise.
Section 8. Invalidity of any Provision of this Article. The invalidity or
unenforceability of any provision of this Article shall not affect the validity or enforceability
of the remaining provisions of this Article.
We also maintain directors and officers liability insurance which may, in some instances,
reimburse us for judgments against us or our directors or officers.
II-3
ITEM 7. Exemption from Registration Claimed.
Not applicable.
II-4
ITEM 8. Exhibits
|
|
|
Exhibit No. |
|
Description of Exhibit |
4.1
|
|
Common Stock specimen, filed as Exhibit 4(a) to the
Registrants Form 10-K for the fiscal year ended December 31,
2002, and is incorporated herein by reference |
|
|
|
4.2
|
|
Rights Agreement, dated as of September 27, 2002, between the
Registrant and American Stock Transfer and Trust Company filed
as Exhibit 4.0 to Registrants Current Report on Form 8-K
filed October 11, 2002, and is incorporated herein by
reference |
|
|
|
4.3
|
|
Rights Certificate relating to the rights granted to holders
of common stock under the Rights Agreement filed as Exhibit
4.0 to Registrants Current Report on Form 8-K, filed on
October 11, 2002, and is incorporated herein by reference |
|
|
|
5.1
|
|
Opinion of Reed Smith LLP |
|
|
|
23.1
|
|
Consent of independent registered public accounting firm |
|
|
|
23.2
|
|
Consent of Reed Smith LLP (included in Exhibit 5.1) |
|
|
|
24.1
|
|
Power of Attorney (contained on Signature Page) |
ITEM 9. Undertakings
(a) The undersigned registrant hereby undertakes:
(1) to file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) to include in any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) to reflect in the prospectus any facts or events arising after the effective date of this
registration statement (or the most recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the information set forth in this registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and
any deviation from the low or high end of the estimated maximum offering range may be reflected in
the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes
in volume and price represent no more than a 20% change in the maximum aggregate offering price set
forth in the Calculation of Registration Fee table in the effective registration statement;
(iii) to include any material information with respect to the plan of distribution not
previously disclosed in this registration statement or any material change to such information in
this registration statement;
provided, however, that paragraphs (a)(1)(i), and (a)(1)(ii) above do not apply if the registration
statement is on Form S-8 and the information required to be included in a post-effective amendment
by those paragraphs is contained in periodic reports filed with or furnished to the SEC by the
registrant pursuant to Section 13 or 15(d) of the Exchange Act that are incorporated by reference
in the registration statement.
II-5
(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.
(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.
(b) The undersigned registrant hereby undertakes that, 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 (and, where applicable, each filing of an
employee benefit plans annual report pursuant to 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.
(c) Insofar as indemnification for liabilities arising under the Securities Act 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 SEC
such indemnification is against public policy as expressed in the Securities 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 Securities Act and will be
governed by the final adjudication of such issue.
II-6
SIGNATURES
The Registrant: Pursuant to the requirements of the Securities Act of 1933, as amended, the
registrant certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-8 and has duly caused this registration statement on Form S-8 to
be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Wilmington,
Commonwealth of Massachusetts, on this 5th day of November, 2010.
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DUSA PHARMACEUTICALS, INC.
|
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By: |
/s/ Robert F. Doman
|
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Robert F. Doman |
|
|
|
President and Chief Executive Officer |
|
|
POWER OF ATTORNEY
Know All Men By These Presents, that each person whose signature appears below constitutes and
appoints Robert F. Doman and Richard C. Christopher, and each of them singly, as his/her true and
lawful attorney-in-fact and agent with full power of substitution and resubstitution, for him/her
and in his/her name, place and stead, in any and all capacities, to sign any or all amendments
(including post-effective amendments) to this registration statement or any related registration
statement, including any amendment to this registration statement for the purpose of registering
additional shares in accordance with General Instruction E to Form S-8, and to file the same, with
all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorney-in-fact and agent full power and authority to do and
perform each and every act and thing requisite and necessary to be done in connection with the
above premises, as fully to all intents and purposes as he/she might or could do in person, hereby
ratifying and confirming all that said attorney-in-fact and agent or his/her substitute or
substitutes, may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration
Statement on Form S-8 has been signed by the following persons in the capacities and on the dates
indicated:
|
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/s/ Alfred Altomari
|
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Director
|
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November 5, 2010 |
|
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Alfred Altomari
|
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Date |
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|
/s/ David M. Bartash
|
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Vice Chairman of the Board of Directors
|
|
November 5, 2010 |
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and Lead Director
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Date |
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|
/s/ Alexander W. Casdin
|
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Director
|
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November 5, 2010 |
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Alexander W. Casdin
|
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Date |
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/s/ Richard C. Christopher
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Vice President, Finance and Chief
|
|
November 5, 2010 |
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Financial Officer (principal financial
officer and principal accounting officer)
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|
Date |
II-7
|
|
|
|
|
/s/ Robert F. Doman
|
|
Director, President and Chief
|
|
November 5, 2010 |
|
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Executive Officer (principal executive officer)
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|
Date |
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|
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/s/ Jay M. Haft, Esq.
|
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Chairman of the Board of Directors
|
|
November 5, 2010 |
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and Director
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Date |
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/s/ Paul J. Hondros
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Director
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November 5, 2010 |
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Paul J. Hondros
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Date |
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/s/ Magnus Moliteus
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Director
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November 5, 2010 |
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Magnus Moliteus
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Date |
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/s/ David M. Wurzer
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Director
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November 5, 2010 |
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David M. Wurzer
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Date |
II-8
EXHIBIT INDEX
|
|
|
Exhibit No. |
|
Description of Exhibit |
4.1
|
|
Common Stock specimen, filed as Exhibit 4(a) to the
Registrants Form 10-K for the fiscal year ended December 31,
2002, and is incorporated herein by reference |
|
|
|
4.2
|
|
Rights Agreement, dated as of September 27, 2002, between the
Registrant and American Stock Transfer and Trust Company filed
as Exhibit 4.0 to Registrants Current Report on Form 8-K
filed October 11, 2002, and is incorporated herein by
reference |
|
|
|
4.3
|
|
Rights Certificate relating to the rights granted to holders
of common stock under the Rights Agreement filed as Exhibit
4.0 to Registrants Current Report on Form 8-K, filed on
October 11, 2002, and is incorporated herein by reference |
|
|
|
5.1
|
|
Opinion of Reed Smith LLP |
|
|
|
23.1
|
|
Consent of independent registered public accounting firm |
|
|
|
23.2
|
|
Consent of Reed Smith LLP (included in Exhibit 5.1) |
|
|
|
24.1
|
|
Power of Attorney (contained on Signature Page) |
II-9