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POZEN Reports Fourth Quarter & Year End 2013 Results
Company Confirms Strategic Goals of Maximizing Shareholder Value, Expense Control and Returning Excess Cash to Shareholders
2013 and Recent Corporate Highlights
September 2013, POZENand Sanofi US announced the signing of an exclusive license agreement for the commercialization of PA8140/PA32540. Under the terms of the agreement, Sanofi US will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZENreceived an upfront payment of $15 millionand will be eligible for pre-commercial milestone payments of up to $20 millionand other future milestone payments and royalties on product sales. Sanofi US has responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S. POZENretains responsibility for obtaining approval of the NDA, after which time POZENwill transfer the NDA to Sanofi US.
November 2013, AstraZeneca ABand Horizon Pharma USA, Inc.(NASDAQ: HZNP) announced that they entered into an agreement for Horizon to acquire the U.S. rights for VIMOVO® (naproxen / esomeprazole magnesium) delayed release tablets. Under the terms of the agreement, POZENwill continue to receive a 10% royalty on net sales of products sold in the United States, with guaranteed annual minimum royalty payments of $5 millionin 2014, and $7.5 millioneach year thereafter, provided that the patents owned by POZENwhich cover VIMOVO are in effect and no generic forms of VIMOVO are on the market. Also under the agreement, Horizon has assumed AstraZeneca’s right to lead the on-going Paragraph IV litigation for VIMOVO and will assume all patent-related defense costs relating to such litigation, including reimbursement for a specified amount of the cost of counsel retained by POZEN. AstraZenecawill continue to have rights to commercialize VIMOVO outside of the United States.
The POZEN Board of Directors declared a special cash distribution of
$1.75per share to all stockholders of record as of the close of business on December 11, 2013, and payment was made on December 30, 2013. This distribution represented a surplus of corporate cash and was treated as a return of capital to stockholders.
Results from POZEN’s Phase 1 study, PA10040-101, demonstrated that
PA10040, POZEN’s proprietary combination of aspirin (100 mg) and
omeprazole (40 mg), had comparable bioavailability, and is
bioequivalent to a
European Union(E.U.) reference listed enteric-coated (EC) aspirin (100 mg). The 100 mg dose of aspirin is most commonly used in Europeand in other ex-U.S. regions.
Q4 2013 global net sales of VIMOVO by
AstraZeneca, as defined under our agreement, were $25 million, up 36% vs. Q4 2012 and up 9% from Q3 2013. POZENearned a royalty of $1.7 millionin Q4 2013. Total 2013 net sales of VIMOVO were $91 million, up 42% from 2012, and POZENearned a royalty of $6.3 million, up 30% year on year. We anticipate continued growth in VIMOVO sales and royalties this year.
Fourth Quarter Results
For the fourth quarter of 2013,
Operating expenses for the fourth quarter of 2013 totaled
The Company reported a net loss of
Twelve Month Results
For the twelve months ended
Operating expenses for the twelve months ended
For the full year of 2013, the Company reported a net loss of
2014 Strategic Direction
The Company was pleased to return
Fourth Quarter Results Webcast
The Company's common stock is traded under the symbol “POZN” on The
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 a pH-sensitive coating of an aspirin core. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
Proposed PA8140/PA32540 Indications and Usage (Pending FDA Review and Approval)
PA8140/PA32540 Tablets contain 81 mg or 325 mg delayed release aspirin and 40 mg immediate-release omeprazole and are indicated for patients who require aspirin (1) to reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, (2) to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, (3) to reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris, (4) in patients who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated, and to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers.
Controlled studies with PA8140/PA32540 Tablets do not extend beyond 6 months.
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 www.vimovo.com.
Statements included in this press release that are not historical in
nature are “forward-looking statements” within the meaning of the “safe
harbor” provisions of the Private Securities Litigation Reform Act of
1995. You should be aware that our actual results, our ability to return
value to our stockholders, including any cash distributions, and our
future prospects could differ materially from those contained in the
forward-looking statements, which are based on current market data and
research (including third party and
Statements of Operations
Three Months Ended
Twelve Months Ended
|Selling, general and administrative||4,631,232||4,861,339||17,160,810||19,024,164|
|Research and development||2,238,076||2,631,591||9,945,049||11,866,554|
|Total operating expenses||6,869,308||7,492,930||27,105,859||30,890,718|
|Interest and other income, net||21,129||52,097||75,560||258,697|
|(Loss) net income attributable to common stockholders||$||(2,175,179||)||$||(6,088,833||)||
|Basic net (loss) income per common share||$||(0.07||)||$||(0.20||)||
|Shares used in computing basic net (loss) income per common share||30,582,255||30,310,446||30,449,721||30,091,985|
|Diluted net (loss) income per common share||$||(0.07||)||
|Shares used in computing diluted net (loss) income per common share||30,582,255||30,310,446||30,449,721||30,091,985|
|December 31,||December 31,|
|Cash and cash equivalents||$||32,827,732||$||68,416,308|
|Prepaid expenses and other current assets||794,665||858,423|
|Total current assets||35,295,397||89,524,867|
|Equipment, net of accumulated depreciation||38,979||71,945|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||17,545,651||5,519,450|
|Total stockholders’ equity||17,788,725||84,077,362|
|Total liabilities and stockholders’ equity||$||35,334,376||$||89,596,812|
Bill Hodges, Chief Financial Officer
Manager, Investor Relations & Public Relations