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POZEN Reports Fourth Quarter & Year End 2012 Results

In the combined data from the two trials, 85.1% of subjects on enteric-coated aspirin (325 mg) reported adverse events compared to 71.8% of subjects on PA32540. The most commonly reported adverse events with PA32540 and enteric-coated aspirin (325 mg) were of the GI tract and include dyspepsia (11.3% vs. 30.2%), erosive gastritis (11.5% vs. 26.3%), and gastritis (17.5% vs. 16.0%) respectively. The incidence and nature of adjudicated MACE such as heart attacks was similar between the 2 treatment arms: 9 subjects (1.7%) on PA32540 experienced adjudicated MACE compared to 13 subjects (2.5%) on aspirin (325 mg).

About VIMOVO

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.

About Treximet

Treximet ® (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, Treximet 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 www.treximet.com.

Forward-Looking Statements

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 could differ materially from those contained in the forward-looking statements, which are based on current market data and research (including third party and POZEN sponsored market studies and reports), management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to license our PA product candidates on terms and timing acceptable to us, our inability to file a new drug application with the FDA for our PA product candidates in the timeframe we anticipate, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on AstraZeneca for the sales and marketing of VIMOVO ® ; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended September 30, 2012. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

 

POZEN Inc.

Statements of Operations

(Unaudited)

 
    Three Months Ended

December 31,

    Twelve Months Ended

December 31,

2012       2011 2012       2011
Revenue:    
Sale of royalty rights, net of costs $ $ 71,870,283

$

$ 71,870,283
Royalty revenue 1,352,000 1,130,000 4,849,000 15,080,234
Licensing revenue 500,000
Total revenue 1,352,000 73,000,283 5,349,000 86,950,517
Operating expenses:
Selling, general and administrative 4,861,339 6,978,795 19,024,164 21,752,299
Research and development 2,631,591 4,552,440 11,866,554 23,020,129
Total operating expenses 7,492,930 11,531,235 30,890,718 44,772,428
Other income:
Interest and other income, net 52,097 24,541 258,697 161,443
(Loss) income before income tax benefit (6,088,833 ) 61,493,589 (25,283,021 ) 42,339,532
Income tax expense
(Loss) net income attributable to common stockholders $ (6,088,833 ) $ 61,493,589 $ (25,283,021 ) $ 42,339,532
 
Basic net (loss) income per common share $ (0.20 ) $ 2.05 $ (0.84 ) $ 1.41
 
Shares used in computing basic net (loss) income per common share 30,310,446 29,974,525 30,091,985 29,924,944
 
Diluted net (loss) income per common share $ (0.20 ) 2.04 $ (0.84 ) $ 1.40
 
Shares used in computing diluted net (loss) income per common share 30,310,446 30,137,047 30,091,985 30,296,200
 

POZEN Inc.

Balance Sheets

(Unaudited)

 
    December 31,     December 31,
2012 2011
ASSETS
Current assets:
Cash and cash equivalents $ 68,416,308 $ 104,990,723
Short-term investments 18,898,136 14,629,416
Accounts receivable 1,352,000 1,130,000
Prepaid expenses and other current assets 858,423 700,326
Total current assets 89,524,867 121,450,465
Equipment, net of accumulated depreciation 71,945 102,910
Total assets $ 89,596,812 $ 121,553,375
 
 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,231,761 $ 2,269,271
Payable for unsettled investment purchases 5,752,735
Accrued compensation 2,574,334 2,168,341
Accrued expenses 1,456,055 3,577,606
Accrued contract costs 2,029,878
Deferred revenue 257,300 257,300
Total current liabilities 5,519,450 16,055,131
 
 
Total stockholders’ equity 84,077,362 105,498,244
Total liabilities and stockholders’ equity $ 89,596,812 $ 121,553,375




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