POZEN Reports PA32540 / PA8140 Updates and Second Quarter 2012 Financial Results
POZEN Inc.Bill Hodges, 919-913-1030Chief Financial OfficerorStephanie Bonestell, 919-913-1030Manager, Investor Relations & Public Relations
,a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the second quarter ended June 30, 2012.
For the second quarter of 2012, POZEN reported revenue of $1.8 million, comprised of $1.3 million VIMOVO royalty from AstraZeneca and $0.5 million license revenue of MT 400. For the second quarter of 2011, the Company reported total revenue of $4.6 million, resulting from royalty on sales of (sumatriptan / naproxen sodium) of $4.0 million, and $0.6 million from royalty on sales of VIMOVO. POZEN sold most of the future royalty and milestone payments under its collaboration and license agreement with Glaxo Group Limited, part of the GlaxoSmithKline group of companies (GSK), covering sales in the United States to a financial investor in November 2011.
Operating expenses for the second quarter of 2012 totaled $6.9 million, as compared to $11.0 million for the comparable period in 2011. The decrease in operating expenses in the second quarter of 2012 was primarily a result of the completion of the PA32540 Phase 3 studies.
The Company reported a net loss of $(5.1) million, or $(0.17) per share on a diluted basis, for the second quarter of 2012, compared to net loss of $(6.4) million, or $(0.21) per share on a diluted basis, for the second quarter of 2011.
For the six months ended June 30, 2012, POZEN reported revenue of $3.1 million compared to $9.0 million for the same period in 2011. The decrease in revenue is due to the prior year monetization of the royalty.
Operating expenses for the six months ended June 30, 2012 were $16.7 million compared to $21.3 million in the same period in 2011. The decrease in operating expenses is primarily due to the completion of the PA32540 studies.
The Company reported a net loss of $(13.5) million, or $(0.45) per share on a diluted basis for the six month period ended June 30, 2012, compared to a net loss of $(12.1) million, or $(0.40) per share on a diluted basis, for the same period in 2011.
At June 30, 2012, cash, cash equivalents and short-term investments totaled $95.3 million. Cash and short-term investments were $119.6 million at December 31, 2011. The 2012 decrease was a result of an early January payment for the late December purchase of $5.8 million of short-term investments, payment of accrued costs of $3.6 million, mainly related to PA32540 Phase 3 studies and payment of other cash expenses. The Company had an accounts receivable balance of $1.3 million from AstraZeneca at June 30, 2012.
In light of our recent discussions with the FDA regarding the NDA for PA32540, we are continuing to re-evaluate our financial outlook for the year, and we plan to update when we complete our assessment.
POZEN will host a webcast to present second quarter 2012 results and management’s outlook on Wednesday, August 1, 2012 at 11:00 a.m. (ET). The webcast can be accessed live and will be available for replay at .
POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestone/royalty streams, POZEN is now creating a portfolio of cost-effective, evidence based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the opportunity for its portfolio assets.
The Company's common stock is traded under the symbol “POZN” on The NASDAQ Global Market. For more detailed company information, including copies of this and other press releases, please visit .
POZEN is creating a portfolio of integrated aspirin therapies - the PA product platform. The products in the PA portfolio are intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone.
The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and an indication will be sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
VIMOVO™ (naproxen / esomeprazole magnesium) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.VIMOVO is not recommended for use in children younger than 18 years of age. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.
For Full Prescribing Information see .
(sumatriptan / naproxen sodium)was approved by the U.S. Food and Drug Administration (FDA) in April 2008 for the acute treatment of migraine attacks, with or without aura, in adults. The product is formulated with POZEN’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology™. This migraine medication contains sumatriptan, a 5-HT1 receptor agonist that mediates vasoconstriction of the human basilar artery and vasculature of human dura mater, which correlates with the relief of migraine headache. It also contains naproxen, an NSAID that inhibits the synthesis of inflammatory mediators. Therefore, sumatriptan and naproxen contribute to the relief of migraine through pharmacologically different mechanisms of action. As a result of this dual mechanism of action, has been shown to provide superior sustained pain relief compared to placebo and to both of the single mechanism of action components.
For Full Prescribing Information see .