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POZEN Reports Second Quarter 2013 Results

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

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 March 31, 2013. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.


Statements of Operations

Three Months Ended

June 30,
Six Months Ended

June 30,
2013       2012 2013       2012
Royalty revenue $ 1,651,000 $ 1,268,000 $ 3,066,000 $ 2,557,000
Licensing revenue 500,000 500,000
Total revenue 1,651,000 1,768,000 3,066,000 3,057,000
Operating expenses:
Selling, general and administrative 3,713,032 4,070,707 7,347,076 9,718,630
Research and development 1,941,346 2,874,068 5,525,286 6,978,514
Total operating expenses 5,654,378 6,944,775 12,872,362 16,697,144
Other income:
Interest and other income, net 15,382 72,663 40,434 141,300
Loss before income tax benefit (3,987,996 ) (5,104,112 ) (9,765,928 ) (13,498,844 )
Income tax expense

Net loss attributable to commonstockholders
$ (3,987,996 ) $ (5,104,112 ) $ (9,765,928 ) $ (13,498,844 )

Basic and diluted net loss per common share
$ (0.13 ) $ (0.17 ) $ (0.32 ) $ (0.45 )

Shares used in computing basic and diluted net lossper common share
30,403,670 29,998,006 30,370,034 29,986,590


Balance Sheets

    June 30,   December 31,
2013 2012
Current assets:
Cash and cash equivalents $ 76,931,505 $ 68,416,308
Short-term investments 18,898,136
Accounts receivable 1,651,000 1,352,000
Prepaid expenses and other current assets 263,550 858,423
Total current assets 78,846,055 89,524,867
Equipment, net of accumulated depreciation 54,957 71,945
Total assets $ 78,901,012 $ 89,596,812
Current liabilities:
Accounts payable $ 334,820 $ 1,231,761
Accrued compensation 1,150,159 2,574,334
Accrued expenses 1,346,768 1,456,055
Deferred revenue 257,300 257,300
Total current liabilities 3,089,047 5,519,450
Total stockholders’ equity 75,811,965 84,077,362
Total liabilities and stockholders’ equity $ 78,901,012 $ 89,596,812

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