|View printer-friendly version|
POZEN Reports Third Quarter 2013 Results
Exclusive License Agreement for U.S. Rights to PA8140/PA32540 Signed with Sanofi US
Recent Corporate Highlights
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. The upfront payment will be amortized over fifteen months starting in September 2013.
Sanofi US will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S.
POZENwill retain responsibility for obtaining approval of the New Drug Application (NDA), after which time POZENwill transfer the NDA to Sanofi US. The NDA was submitted in March 2013and accepted for filing in May 2013by the U.S. Food and Drug Administration( FDA) and has a user fee action date of January 24, 2014.
As part of POZEN’s ongoing interactions and requests for information
FDAduring its review of the NDA for PA8140/PA32540, the FDAhas requested a teleconference, which has been scheduled for mid-November. POZENwill discuss and address the FDA’s request for information with respect to the existing clinical pharmacology data on PA8140.
POZENis focusing its efforts on obtaining FDAapproval of PA8140/PA32540, transitioning all know-how to Sanofi US, completing the remaining Phase 1 study and MAA filing for PA10040, evaluating the possibility of a MAA filing using existing data for the use of PA in secondary cancer prevention, attempting to partner all un-partnered assets, and reducing staff and expenses as warranted by business conditions. In addition, POZEN’s management team and board of directors are evaluating possible ways of returning value to shareholders, including cash distributions of surplus corporate cash.
Liz Cermak, Executive Vice President and Chief Commercial Officer, has announced her retirement from POZEN. Ms. Cermak led many facets of our PA program including POZEN’s efforts to secure the best agreement possible for shareholders with Sanofi US. POZENwill complete its commercial obligations to Sanofi US before the end of the fourth quarter, thus allowing Ms. Cermak the opportunity to retire at the end of the year.
In August, results of a
POZEN-funded, community based study, demonstrating that concomitant proton pump inhibitor (PPI) therapy improves adherence in low-dose aspirin (ASA) users, was presented at the European Society of Cardiology Congress2013 in Amsterdam.
POZENand AstraZeneca ABexecuted two agreements in September relating to VIMOVO® (naproxen / esomeprazole magnesium). An amendment to parties’ 2006 license and collaboration agreement clarified the intellectual property provisions of the agreement to expressly exclude products that contain aspirin. The other agreement provided, among other things, that in the event that AstraZenecadivests its rights to commercialize VIMOVO in the US, AstraZenecawill be relieved of its obligation to guarantee the performance of the acquiring party.
Q3 2013 global net sales of VIMOVO by
AstraZeneca, as defined under our agreement, were $23 million, up 72% vs. Q3 2012 and down 1% from Q2 2013. POZENearned a royalty of $1.6 millionin Q3 2013.
Third Quarter Results
For the third quarter of 2013,
Operating expenses for the third quarter of 2013 totaled
Nine Month Results
For the nine months ended
Operating expenses for the nine months ended
Third 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
Nine Months Ended
|Selling, general and administrative||5,182,501||4,444,194||12,529,577||14,162,824|
|Research and development||2,181,689||2,256,450||7,706,975||9,234,964|
|Total operating expenses||7,364,190||6,700,644||20,236,552||23,397,788|
|Interest and other income, net||13,997||65,300||54,431||206,600|
|Loss before income tax benefit||(4,767,193||)||(5,695,344||)||(14,533,121||)||(19,194,188||)|
|Income tax expense||—||—||—||—|
Net loss attributable to common
Basic and diluted net loss per common
Shares used in computing basic and
diluted net loss per common share
|September 30,||December 31,|
|Cash and cash equivalents||$||89,695,509||$||68,416,308|
|Prepaid expenses and other current assets||105,565||858,423|
|Total current assets||91,384,074||89,524,867|
|Equipment, net of accumulated depreciation||47,813||71,945|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||16,860,007||5,519,450|
|Total stockholders’ equity||72,571,880||84,077,362|
|Total liabilities and stockholders’ equity||$||91,431,887||$||89,596,812|
Bill Hodges, 919-913-1030
Chief Financial Officer
Stephanie Bonestell, 919-913-1030
Manager, Investor Relations & Public Relations