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POZEN Reports First Quarter 2014 Results
Net Income Increases to
POZENreported net income of $2.9 millionfor the first quarter and expects to be profitable for the year, based upon current projections.
Royalty revenue for Q1 2014 was
$4.5 million, an increase of $2.9 millionover the prior quarter and $3.1 millionover Q1 of 2013.
POZENremains committed to controlling expenses and recorded a reduction of $2.6 millioncompared to Q1 2013. As part of the expense control, the Company has reduced its R&D staff and other costs and will continue to reduce staff not required to support our ongoing business activities.
POZENannounced that its drug candidates PA8140/PA32540 (aspirin and omeprazole) delayed release tablets received a complete response letter (CRL) from the U.S. Food and Drug Administration( FDA). A CRL is issued by the FDAwhen the review of the file is completed and questions remain that preclude the approval of the new drug application (NDA) in its current form. In the CRL, the FDAnoted that, during an inspection of the manufacturing facility of an active ingredient supplier, inspection deficiencies were found. There were no clinical or safety deficiencies noted with respect to either PA8140 or PA32540 and no other deficiencies were noted in the CRL.
First Quarter Results
For the first quarter of 2014,
Operating expenses for the first quarter of 2014 totaled
The Company reported net income of
2014 Strategic Direction
The Company was pleased to return
First Quarter Results Webcast
The Company's common stock is traded under the symbol “POZN” on The
The first candidates are PA8140, containing 81 mg of aspirin, and PA32540, containing 325 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.
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
|Selling, general and administrative||2,823,518||3,634,043|
|Research and development||1,827,878||3,583,940|
|Total operating expenses||4,651,396||7,217,983|
|Interest and other income, net||7,411||25,051|
|Net income / (loss) attributable to common stockholders||$||2,904,691||$||(5,777,932||)|
|Basic net income / (loss) per common share||$||0.09||$||(0.19||)|
|Shares used in computing basic net income / (loss) per common share||30,743,966||30,336,398|
|Diluted net income / (loss) per common share||$||0.09||$||(0.19||)|
|Shares used in computing diluted net income / (loss) per common share||32,489,969||30,336,398|
|March 31,||December 31,|
|Cash and cash equivalents||$||27,143,450||$||32,827,732|
|Prepaid expenses and other current assets||711,047||794,665|
|Total current assets||32,403,173||35,295,397|
|Equipment, net of accumulated depreciation||34,024||38,979|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||10,614,267||17,545,651|
|Total stockholders’ equity||21,822,930||17,788,725|
|Total liabilities and stockholders’ equity||$||32,437,197||$||35,334,376|
Bill Hodges, Chief Financial Officer
Manager, Investor Relations & Public Relations