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POZEN Reports Second Quarter 2014 Results
Record Quarterly VIMOVO® Sales Generate >
POZENreported net income of $3.0 millionfor the second quarter and, based upon current projections, expects to be profitable for the year.
Royalty revenue from VIMOVO® (naproxen / esomeprazole
magnesium) for Q2 2014 was
$5.4 million, an increase of $0.9 millionover the prior quarter and $3.8 millionover Q2 of 2013.
POZENannounced that the resubmission of the New Drug Application (NDA) for PA8140/PA32540 was submitted to the U.S. Food and Drug Administration( FDA), and has been accepted for review. The FDAindicated the NDA would be treated as a Class 2 resubmission with a new user fee goal date of December 30, 2014.
POZENremains committed to controlling expenses and recorded an expense reduction of $1.2 millioncompared to Q2 2013. As part of the expense control, the Company has reduced its R&D staff and other costs and will continue to reduce costs not required to support the ongoing business activities.
Horizon Pharma, Inc., which acquired rights to market VIMOVO in the United Statesfrom AstraZenecain November 2013, announced that it was verbally notified by CVS Caremarkand Express Scripts, Inc.that VIMOVO would no longer be on their formularies and will be placed on their exclusion lists effective January 1, 2015. Horizon estimates that approximately 20-30% of VIMOVO prescriptions could be impacted by these decisions. While Horizon believes it has a strategy to mitigate the effect on VIMOVO sales, POZEN’s royalty revenue from net sales of VIMOVO beginning in 2015 may be negatively affected. POZENreceives a 10% royalty on net sales of VIMOVO sold by Horizon 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.
May 2014, as part of its intended acquisition of Treximet® (sumatriptan / naproxen sodium) from GlaxoSmithKline(GSK), Pernix Therapeutics Holdings, Inc.( Pernix) granted POZENa warrant to purchase 500,000 shares of Pernixcommon stock at an exercise price of $4.28. The common stock underlying the warrants will be registered by Pernixwith the Securities and Exchange Commissionand will be exercisable from the closing date of the acquisition until February 28, 2018. If the acquisition is not completed, the warrants will be cancelled. Previous restrictions on POZEN’s right to develop and commercialize additional certain dosage forms of sumatriptan / naproxen combinations outside of the United Statesand use of the approved U.S. New Drug Application will be eliminated upon closing of Pernix’s transaction with GSK.
Second Quarter Results
For the second quarter of 2014,
Operating expenses for the second quarter of 2014 totaled
The Company reported net income of
Six Month Results
For the first half of 2014,
Operating expenses for the first half of 2014 totaled
The Company reported net income of
2014 Strategic Direction
For 2014, the Company’s areas of strategic focus are: obtaining
Second 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.
Treximet® (sumatriptan / naproxen sodium) was approved
For Full Prescribing Information see www.treximet.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
Six Months Ended
|Selling, general and administrative||2,500,223||3,713,032||5,323,741||7,347,076|
|Research and development||1,926,392||1,941,346||3,754,270||5,525,286|
|Total operating expenses||4,426,615||5,654,378||9,078,011||12,872,362|
|Interest and other income, net||6,766||15,382||14,177||40,434|
|Net income / (loss) attributable to common stockholders||$||2,999,457||$||(3,987,996||)||$||5,904,148||$||(9,765,928||)|
|Basic net income / (loss) per common share||$||0.10||$||(0.13||)||$||0.19||$||(0.32||)|
|Shares used in computing basic net income / (loss) per common share||31,022,557||30,403,670||30,883,261||30,370,034|
|Diluted net income / (loss) per common share||$||0.09||$||(0.13||)||$||0.18||$||(0.32||)|
|Shares used in computing diluted net income / (loss) per common share||32,604,123||30,403,670||32,458,718||30,370,034|
|June 30,||December 31,|
|Cash and cash equivalents||$||31,790,885||$||32,827,732|
|Prepaid expenses and other current assets||491,418||794,665|
|Total current assets||37,763,619||35,295,397|
|Equipment, net of accumulated depreciation||29,625||38,979|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||9,102,986||17,545,651|
|Total stockholders’ equity||28,690,258||17,788,725|
|Total liabilities and stockholders’ equity||$||37,793,244||$||35,334,376|
Bill Hodges, Chief Financial Officer
Stephanie Bonestell Manager, Investor Relations & Public Relations