POZEN reports Q2 2009 results, submits new drug application

July 28, 2009 By: NCTechNews Category: Pharmaceuticals

(Chapel Hill, N.C.) POZEN Inc. (NASDAQ: POZN), today announced results for the second quarter ended June 30, 2009. POZEN reported a net loss of $(4.3) million, or $(0.14) per share on a diluted basis, for the second quarter of 2009, compared to net income of $13.3 million, or $0.43 per share on a diluted basis, for the second quarter of 2008.

For the second quarter of 2009, POZEN reported revenue of $4.9 million resulting from the amortization of upfront payments received pursuant to the collaboration agreement with AstraZeneca of $3.1 million, royalties of $0.9 million on sales of Treximet® (sumatriptan and naproxen sodium), and revenue from development work performed under the AstraZeneca agreement of $0.9 million. Revenue for the second quarter ended June 30, 2008 totaled $33.1 million, and includes a $20.0 million milestone for the New Drug Application (NDA) approval of Treximet, and $8.6 million of revenue for development work.

Operating expenses for the second quarter of 2009 totaled $9.3 million as compared to $20.3 million for the comparable period in 2008. The decrease in operating expenses was primarily due to a decrease in costs associated with the PN and PA development programs, partially offset by legal costs incurred to defend our intellectual property.

At June 30, 2009, cash, cash equivalents and short-term investments totaled $48.0 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, after receipt of the expected $10.0 million milestone payment from AstraZeneca in the third quarter.

POZEN reported a net loss of $(7.7) million, or $(0.26) per share on a diluted basis, for the six month period ended June 30, 2009, compared to a net income of $6.0 million, or $0.19 per share on a diluted basis, for the same period in 2008.

For the six months ended June 30, 2009, POZEN reported revenue of $13.7 million compared to $41.0 million for the same period in 2008. The decrease in revenue was primarily due to $7.0 million less development revenue in 2009 and the prior year $20.0 million milestone payment for Treximet.

Operating expenses for the six months ended June 30, 2009 were $21.8 million as compared to $36.2 for the same period in 2008. The decrease in operating expenses was primarily due to a decrease in costs for the PN and PA development programs, partially offset by higher legal costs incurred to defend our intellectual property.

Year to date net sales of Treximet totaled $39.3 million for GlaxoSmithKline in 2009, generating YTD royalty revenue of $2.0 million for POZEN. According to IMS Health, total prescriptions of Treximet in the second quarter of 2009 were 16.3% higher than the first quarter of 2009.

The NDA for VIMOVO (naproxen/esomeprazole magnesium) was submitted in June 2009.

Pursuant to the collaboration agreement, POZEN expects to receive a $10 million milestone payment from AstraZeneca upon acceptance of the NDA by the U.S. Food and Drug Administration (FDA). Of the 140 million osteoarthritis patients in the world, 50% are at gastrointestinal risk. Only 25% of those at risk receive a co-prescribed gastro-protective agent, and of those who do, the majority is non-compliant, representing a large unmet need. VIMOVO is being developed for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing NSAID-associated gastric ulcers.

The Company is planning to begin Phase 3 studies for PA32540 in the fall of 2009. POZEN does not plan to seek a license partner for PA32540 until after the commercialization strategy for the PA products is finalized.

POZEN will hold a webcast to present second quarter 2009 results and management’s outlook on Tuesday, July 28, 2009 at 11:00 a.m. Eastern time. The webcast can be accessed live and will be available for replay at www.pozen.com.

POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN’s efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet®, which was approved in 2008 by the United States Food and Drug Administration for the acute treatment of migraine attacks, with or without aura, in adults, and with AstraZeneca for VIMOVO™, the proposed trade name for the proprietary fixed dose combination of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers.

The Company’s common stock is traded on The NASDAQ Stock Market under the symbol “POZN”. For detailed company information, see POZEN’s website: www.pozen.com.

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