(nasd) DUSA $2.06 DUSA Pharmaceuticals Reports First Quarter 2008 Corporate Highlights and Financial Results
Wednesday, May 07 2008 - 6:30
$-0.04 (%-1.90)
WILMINGTON, MASSACHUSETTS--(Marketwire - May 7, 2008) - DUSA Pharmaceuticals, Inc.(R) (NASDAQ GM:DUSA), a dermatology company that is developing and marketing Levulan(R) photodynamic therapy (PDT) and other products targeting patients with common skin conditions, reported today its corporate highlights and financial results for the first quarter ended March 31, 2008.
Total product revenues were $7.9 million in the first quarter of 2008, up 19% from $6.7 million in the first quarter of 2007. PDT revenues totaled $5.8 million, up 28% from $4.6 million for the comparable 2007 period. The increase in PDT revenues was attributable to a 36% increase in Kerastick(R) revenues, driven by 21% domestic volume growth, as well as international expansion into both Latin America and Korea. Overall Kerastick sales volumes increased 36% from 38,370 units in the first quarter of 2007 to 52,110 units in the first quarter of 2008. Non-PDT revenues were flat at $2.1 million. Non-PDT revenues were primarily driven by the sales of Nicomide(R) which were adversely impacted by the residual levels of the River's Edge product remaining in the distribution channel following the settlement of the litigation between the Company and River's Edge.
DUSA's net loss on a GAAP basis for the first quarter of 2008 was ($1.3) million or ($0.05) per common share, compared to a net loss of ($3.4) million or ($0.17) per common share in the first quarter of 2007.
DUSA's non-GAAP net loss for the first quarter of 2008 was ($0.6) million or ($0.03) per share common, compared to a net loss of ($3.1) million or ($0.16) per share common in the first quarter of 2007, an improvement of 81%. The first quarter 2008 non-GAAP net loss excludes share-based compensation expense of $0.3 million and a non-cash loss on the change in the fair value of warrants of $0.3 million. Please refer to the "Use of Non-GAAP Financial Measures" section and the accompanying financial table included at the end of this release for a reconciliation of GAAP results to non-GAAP results for the three month periods ending March 31, 2007 and 2008, respectively.
As of March 31, 2008, total cash, cash equivalents, and U.S. government securities were $22.9 million, compared to $23.0 million at December 31, 2007. During the first quarter, the Company received a milestone payment from Stiefel Laboratories, Inc. ($0.4 million); as well as, made a milestone payment to the former Sirius shareholders (-$0.3 million). Cash expenditures for the first quarter of 2008, net of non-recurring items, were $0.2 million.
Other updates:
- International Expansion.
- On March 6, 2008, the Company announced that Stiefel Laboratories,
Inc., DUSA's marketing partner for Latin America, had received final
pricing approval for Levulan(R) Kerastick(R) for the treatment of
actinic keratoses (AKs) in Brazil by the Regulatory Chamber of
Medicines (Camara de Regulacao do Mercado de Medicamentos) (CMED).
The product was subsequently launched in Brazil in early April 2008.
The product is now available in Latin America in Argentina, Brazil,
Chile, Colombia, and Mexico.
- Product Development.
- On March 31, 2008, the Company reported that it had completed
enrollment in its Phase IIb clinical trial of Levulan(R) PDT for the
treatment of moderate to severe acne. A total of 266 patients were
accrued at 14 clinical trial sites across the country. The company
expects top-line results to become available in the fall of 2008.
- On May 1, 2008, the Company announced that the National Cancer
Institute (NCI) has launched a Phase I clinical trial using its
aminolevulinic acid product. The study examines an entirely new
approach for the prevention of oral cancer, which may affect more
than 30,000 Americans this year. Chronic mouth lesions, the most
common of which is a condition known as oral leukoplakia, are early
indicators of oral cancer. There is currently no effective treatment
for preventing the progression of oral leukoplakia to cancer. The
long-term goal is to examine aminolevulinic acid (ALA) photodynamic
(PDT) therapy as a preventive treatment for oral cancer by the
selective removal of oral leukoplakia.
- Operations.
- On April 28, 2008, the Company reported that it had been notified by
Actavis Totowa, LLC, the manufacturer of Nicomide, that Actavis will
cease manufacturing several prescription vitamins, including
Nicomide, due to continuing discussions with the U.S. Food and Drug
Administration. As previously disclosed by DUSA, Actavis Totowa had
received notice that the FDA considers prescription dietary
supplements to be unapproved new drugs. DUSA has inventory supplies
of Nicomide, either in the distribution channel or at wholesalers, to
last approximately 6 months at current sales levels. DUSA is
evaluating alternative manufacturing, labeling and distribution
strategies in order to maintain Nicomide on the market.
- Personnel.
- Subsequent to the end of the quarter, on April 21, 2008, the Company
announced that the role of D. Geoffrey Shulman, MD, Chairman of the
Board and Chief Strategic Officer, is expected to change as a result
of a serious health condition. Dr. Shulman, the Company's founder,
served as Chief Executive Officer from 1991 to 2007, and Chairman of
the Board from 1991 to 2003 and again since 2005. Dr. Shulman expects
to be on short term disability commencing in June 2008. DUSA expects
that he will remain on the Board of Directors and will continue as an
employee of the Company in a reduced role.
Management Comments:
"We are pleased with our first quarter 2008 financial results," stated President and CEO Robert Doman. "Our financial statements continue to show improvement. Kerastick revenues increased 36% year over year driven by a 28% increase in US revenues, our quarterly non-GAAP loss improved by 81%, and our quarterly cash burn was reduced to ($0.2) million. In addition, gross margins reached an all time high of 79% for the quarter."
"We also achieved two key operational milestones during the first quarter of 2008 with the receipt of Kerastick pricing approval in Brazil and the completion of enrollment in our Phase IIb clinical trial for moderate to severe acne," continued Doman.
"We look forward to further capitalizing on our PDT franchise opportunities through continued domestic growth, international expansion into new markets, and the addition of new clinical indications," concluded Doman.
Revenues Table, Condensed Consolidated Balance Sheets, Condensed Consolidated Statement of Operations and GAAP to Non-GAAP reconciliation follow:
Revenues for the three-month and twelve-month periods were comprised of the
following:
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