UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 18, 2008
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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| New Jersey
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0-19777
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22-3103129 |
(State or other
jurisdiction of
incorporation)
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(Commission File
Number)
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(IRS Employer
Identification
Number) |
25 Upton Drive
Wilmington, Massachusetts 01887
(Address of principal executive offices, including ZIP code)
(978) 657-7500
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Securities Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events.
On July 18, 2008, DUSA Pharmaceuticals, Inc. (“DUSA”) issued a press release, attached to and
made part of this report, announcing that Nicomide®, the principal product acquired as part of the
merger with Sirius Laboratories, Inc. in March 2006, will no longer be manufactured and marketed
as a prescription product. The decision comes as a proactive action in response to discussions
with the Food and Drug Administration (FDA).
DUSA has placed a voluntary hold on existing inventory of Nicomide® under its control pending
an upcoming meeting with the FDA. The disposition of this inventory will be determined by the
outcome of the meeting. In parallel, repackaging efforts are underway to re-label additional
inventory with DSHEA (Dietary Supplement Health and Education Act) compliant labeling.
DUSA’s total revenues for the full year ended December 31, 2007 and three-month period ended
March 31, 2008 were $27.7 million and $7.9 million, respectively. Of the total revenues for these
periods, $9.4 million and $2.1 million, respectively, were derived from the sale of
Non-Photodynamic Therapy (Non-PDT) products. Nicomide® represented the substantial majority of
DUSA’s Non-PDT revenues in both periods. DUSA expects both the price and volumes of the Nicomide®
DSHEA labeled product, to be considerably less than historical Nicomide® levels.
Except for historical information, this report, including the news release, contains certain
forward-looking statements that involve known and unknown risk and uncertainties, which may cause
actual results to differ materially from any future results, performance or achievements expressed
or implied by the statements made. These forward-looking statements relate to the disposition of
inventory, expectations regarding the price and volumes of a relabeled product, beliefs concerning
commercial strategies, focus for the business and position in the dermatology community.
Furthermore, the factors that may cause differing results include the uncertainties of regulatory
action, ability to market the product with DSHEA labeling, availability of capital, compliance with
regulatory regulations, and other risks identified in DUSA’s SEC filings from time to time.
Item 9.01 — Financial Statement and Exhibits.
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| Item No. |
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Description |
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99.1
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Press Release, dated July 18, 2008 |