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DUSA Pharmaceuticals Reports First Quarter 2009 Corporate Highlights and Financial Results
Tuesday, May 12, 2009 6:54 AM


(Source: MARKETWIRE)trackingDUSA Pharmaceuticals, Inc.(R) (NASDAQ: 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, 2009.

Highlights for the first quarter include:

-- Domestic PDT revenues for the first quarter of 2009 improved by $1.1 million or 21% as compared to the first quarter of 2008.

-- Domestic Kerastick(R) revenues for the quarter increased by $0.9 million or 19% year over year.

-- There were 81 BLU-U(R) units sold during the first quarter of 2009, representing a 45% increase over the first quarter of 2008.

Management Comments:

"While total revenues were down $0.8 million versus the prior year quarter, due primarily to the loss of Nicomide(R) revenues, our domestic PDT business continues to show strong growth," stated Robert Doman, President and CEO. "Domestic PDT revenues for the quarter improved to $6.3 million, representing a 21% increase year over year."

"We are pleased with the success we have experienced in our BLU-U(R) sales volumes over the last two consecutive quarters. We believe that the 45% year over year volume increase realized in the first quarter is indicative of the continued acceptance of our therapy by the medical dermatology community," continued Doman.

"International Kerastick(R) revenues were down $0.2 million versus the prior year quarter, due primarily to initial launch quantities sold in Korea during the first quarter of 2008. However, we are encouraged by the 13% sequential quarter over quarter volume growth in the international markets.

"In the coming months, we expect continued growth of our core PDT business driven in part by the BLU-U(R) units placed over the last few quarters. We will also be working to expand the therapeutic uses of our PDT products through both the expansion of our BLU-U(R) claims and the advancement of our solid organ transplant recipients (SOTRs) clinical trial," concluded Doman.

First Quarter 2009 Financial Results:

Total product revenues were $7.1 million in the first quarter of 2009, down 10% from $7.9 million in the first quarter of 2008. PDT revenues totaled $6.7 million, up $0.9 million or 15% from $5.8 million for the comparable 2008 period. The increase in PDT revenues was attributable to a 13% increase in Kerastick(R) revenues and a 35% increase in BLU-U(R) revenues. The Kerastick(R) revenue increase was driven by an 8% increase in our domestic Kerastick(R) volume and a 14% increase in our average selling price. Overall Kerastick(R) sales volumes were relatively flat year over year, there were 51,947 units sold in the first quarter of 2009 and 52,110 units sold in the first quarter of 2008. Domestic Kerastick(R) sales volumes increased by 3,366 units or 8% and were fully offset by a 3,529 unit decrease in our international sales volumes caused mainly by initial stocking orders placed in Korea during the first quarter of 2008. The BLU-U(R) revenue increase was driven by a 45% increase in sales volume. There were 81 units sold during the quarter, representing a 25 unit increase over the prior year quarterly total of 56 units. Non-PDT revenues totaled $0.4 million versus $2.1 million for the comparable 2008 period. Non-PDT revenues were adversely impacted by the absence of Nicomide(R) sales during the first quarter of 2009. In response to discussions with the Food and Drug Administration (FDA) regarding our marketing of certain products considered by the FDA to be marketed unapproved drugs, the Company stopped shipping Nicomide(R) into the wholesale channel in June of 2008.

DUSA's net loss on a GAAP basis for the first quarter of 2009 was ($1.6) million or ($0.07) per common share, compared to a net loss of ($1.3) million or ($0.05) per common share in the first quarter of 2008. The increase in our net loss was primarily the result of the year over year shortfall in our Non-PDT revenues which was partially offset by incremental PDT revenues, lower operating costs due to the absence of spending on our Phase IIb acne clinical trial which concluded in 2008, and a Prescription Drug User Fee Act (PDUFA) charge accrued in the prior year period.

DUSA's non-GAAP net loss for the first quarter of 2009 was ($1.3) million or ($0.05) per common share, compared to a net loss of ($0.6) million or ($0.03) per common share in the first quarter of 2008. 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, 2008 and 2009, respectively.

As of March 31, 2009, total cash, cash equivalents, and U.S. government securities were $17.9 million, compared to $18.9 million at December 31, 2008, a reduction of $1.0 million during the quarter.

Other Updates:

Clinical Development

-- On May 11, 2009, the Company announced the initiation of its Phase II clinical trial that will examine the safety and efficacy of broad area PDT for the treatment of actinic keratoses and the reduction of new non-melanoma skin cancer (NMSC) in high risk chronically immunosuppressed SOTRs. The 36 patient multi-center pilot study will examine SOTRs with a history of multiple annual squamous cell carcinomas to determine the efficacy of multiple courses of Levulan(R) plus BLU-U(R) treatments over a one year timeframe. The Company is seeking orphan drug designation (ODD) with respect to the prevention of cancer occurrence in these patients. An ODD application has been filed with the FDA and the Company is awaiting the agency's decision.

Nicomide(R)

-- On April 27, 2009, the Company announced that it had amended its existing non-exclusive license agreement with River's Edge, granting them an exclusive license to the patent that covers Nicomide(R) (U.S. Patent No. 6,979,468) and associated know-how, as well as a license to use the trademark associated with the licensed products.



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