| POZEN Reports Third Quarter 2009 Results |
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29/10/2009 17:00 (22 Day 23:06 minutes ago) | |||||
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The FINANCIAL -- POZEN Inc. (NASDAQ: POZN), on October 28 announced results for the third quarter ended September 30, 2009.
POZEN reported a net income of $6.7 million, or $0.22 per share on a diluted basis, for the third quarter of 2009, compared to net loss of $(7.9) million, or $(0.26) per share on a diluted basis, for the third quarter of 2008.
For the third quarter of 2009, POZEN reported revenue of $14.3 million resulting from a $10 million milestone payment for the New Drug Application (NDA) filing for VIMOVO(TM) (naproxen/esomeprazole magnesium), the amortization of upfront payments received pursuant to the collaboration agreement with AstraZeneca of $3.1 million and royalties of $1.2 million on sales of Treximet(R) (sumatriptan and naproxen sodium). Revenue for the third quarter ended September 30, 2008 totaled $11.1 million, resulting from the amortization of upfront payments received pursuant to the collaboration agreements with AstraZeneca and GlaxoSmithKline of $3.2 million, $7.5 million of revenue for development work, and $0.4 million of royalties on sales of Treximet.
Operating expenses for the third quarter of 2009 totaled $7.7 million as compared to $19.5 million for the comparable period in 2008. The decrease in operating expenses was primarily due to a decrease in costs associated with the PN 400 development program.
At September 30, 2009, cash, cash equivalents and short-term investments totaled $51.3 million compared to $61.7 million at December 31, 2008. The Company continues to anticipate ending the year with greater than $45.0 million in cash and investments.
Nine-Month Results
POZEN reported a net loss of $(1.1) million, or $(0.04) per share on a diluted basis, for the nine month period ended September 30, 2009, compared to a net loss of $(1.9) million, or $(0.06) per share on a diluted basis, for the same period in 2008.
For the nine months ended September 30, 2009, POZEN reported revenue of $28.0 million compared to $52.1 million for the same period in 2008. The decrease in revenue was primarily due to $14.6 million less development revenue in 2009 and $10.0 million less in milestone payments in 2009.
Operating expenses for the nine months ended September 30, 2009 were $29.5 million as compared to $55.7 million for the same period in 2008. The decrease in operating expenses was primarily due to a decrease in costs for the PN 400 development program.
Corporate Highlights
VIMOVO(TM), formerly PN 400
The NDA for VIMOVO(TM) was submitted in June 2009. Pursuant to the collaboration agreement, POZEN received a $10 million milestone payment from AstraZeneca in September 2009. Results from the pivotal trials for VIMOVO were presented at the American College of Rheumatology Scientific Session in Philadelphia on October 19, 2009.
Corporate Strategy
POZEN has elected to retain control of its PA product candidates and has hired Elizabeth Cermak as Executive Vice President, Chief Commercial Officer to lead the commercialization strategy, starting with PA32540. PA32540 is currently under investigation for secondary CV/stroke prevention. Retaining control of its product candidates will require that the Company undertake and fund the pre-commercialization activities, but retains the potential upside in the value of the products.
PA Program
The Company initiated the two Phase 3 pivotal trials for PA32540 in October 2009, in addition to a one year long safety study. The primary endpoint for the pivotal trials is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin.
Treximet(R)
Year to date 2009 net sales of Treximet(R) totaled $63.4 million for GlaxoSmithKline, generating YTD royalty revenue of $3.2 million for POZEN.
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