POZEN Reports Second Quarter 2013 Results
NDA for PA8140/PA32540 Accepted for Review by FDA
CHAPEL HILL, N.C. -- August 6, 2013
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming
medicine that transforms lives, today announced results for the second quarter
ended June 30, 2013.
Recent Corporate Highlights
*POZEN announced that the U.S. Food and Drug Administration (FDA) accepted
for review, the New Drug Application (NDA) for PA8140/PA32540. Both
products are coordinated-delivery tablets combining immediate-release
omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a
pH-sensitive coating of an aspirin core. The FDA has assigned a user fee
goal date of January 24, 2014. POZEN is seeking approval for the secondary
prevention of cardiovascular disease in patients at risk for
aspirin-induced gastric ulcers.
*Results from POZEN’s Phase 1 study, PA10040-101, demonstrated that
PA10040, POZEN’s proprietary combination of aspirin (100 mg) and
omeprazole (40 mg), had comparable bioavailability, and is bioequivalent
to a European Union (E.U.) reference listed enteric-coated (EC) aspirin
(100 mg). The 100 mg dose of aspirin is most commonly used in Europe and
in other ex-U.S. regions.
*Data from a post-hoc analysis of diabetic subpopulation results from two
POZEN Phase 3 PA32540 (325 mg EC aspirin / 40 mg immediate-release
omeprazole) studies were presented at the American Diabetes Association’s
73^rd Scientific Session. Nearly 40% of patients in the Phase 3 studies
had diabetes and were on aspirin (325 mg) for secondary prevention of
cardiovascular (CV) events. In this subpopulation (n=400), PA32540 was
associated with a significantly lower rate of endoscopic gastroduodenal
ulcers as compared to taking aspirin alone (2.3% vs. 11.2%, p<0.001). A
lower rate of treatment discontinuation was also observed in this
subpopulation (1.4% vs. 5.9%, p=0.018).
*On July 26, 2013, the United States Court of Appeals for the Federal
Circuit denied a petition by Par Pharmaceuticals Inc. (Par) and Doctor
Reddy’s Laboratories (DRL) for a rehearing en banc in connection with its
September 2012 decision holding that U.S. Patent 7,332,183 covering the
Treximet formulation was valid, enforceable and infringed by their
respective Abbreviated New Drug Application (ANDA) products.
*Partnership discussions for PA continue to progress. While there can be no
assurances, the Company continues to expect to close a partnership deal in
*Q2 2013 global net sales of VIMOVO by AstraZeneca, as defined under our
agreement, were $23.3 million, up 19% from Q1 2013 and 41% vs. Q2 2012.
POZEN earned a royalty of $1.7 million in Q2 2013, a 30% increase over Q2
2012. As discussed in our Q1 Earnings Call, AstraZeneca is discontinuing
certain promotional activities in countries where they have not seen a
positive effect, including the U.S. and most of the E.U.
Second Quarter Results
For the second quarter of 2013, POZEN reported revenue of $1.7 million
compared to total revenue of $1.8 million for the second quarter of 2012.
Revenue for 2013 was royalty for sales of VIMOVO and revenue for 2012 was
comprised of $1.3 million VIMOVO royalty and $0.5 million licensing revenue of
Operating expenses for the second quarter of 2013 totaled $5.7 million, as
compared to $6.9 million for the comparable period in 2012. The decrease in
operating expenses in the second quarter of 2013 was primarily a result of
lower development and pre-commercialization costs for PA.
The Company reported a net loss of ($4.0) million, or ($0.13) loss per share
for the second quarter of 2013, compared to a net loss of ($5.1) million, or
($0.17) per share, for the second quarter of 2012.
First Half Results
For the first half of 2012 and 2013, POZEN reported revenue of $3.1 million.
Revenue in 2012 included $2.6 million of VIMOVO royalty and $0.5 million of
licensing revenue for MT400. Revenue in 2013 was comprised of only VIMOVO
Operating expenses for the first half of 2013 totaled $12.9 million, as
compared to $16.7 million for the comparable period in 2012. The decrease in
operating expenses in the first half of 2013 was primarily a result of lower
development and pre-commercialization costs for PA.
The Company reported a net loss of ($9.8) million, or ($0.32) loss per share
for the first half of 2013, compared to a net loss of ($13.5) million, or
($0.45) per share, for the first half of 2012.
At June 30, 2013, cash and cash equivalents totaled $76.9 million.
2013 Strategic Focus
The Company’s areas of strategic focus for 2013 remain: securing a commercial
partnership(s) for its PA products, completing the PA regulatory submission(s)
in the U.S. and potentially one or more other regions of the world, and
controlling expenses. The Company is estimating a net cash burn of less than
$22 million in 2013, excluding proceeds from any PA deals.
Second Quarter Results Webcast
POZEN will host a webcast to present second quarter 2013 results and
management’s outlook on Tuesday, August 6, 2013 at 11:00 a.m. (ET). The
webcast can be accessed live and will be available for replay at
POZEN Inc. is a small pharmaceutical company that specializes in developing
novel therapeutics for unmet medical needs and licensing those products to
other pharmaceutical companies for commercialization. By utilizing a unique
in-source model and focusing on integrated therapies, POZEN has successfully
developed and obtained FDA approval of two self-invented products in two
years. Funded by these milestones/royalty streams, POZEN is now creating a
portfolio of cost-effective, evidence-based integrated aspirin therapies
designed to enable the full power of aspirin by reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the
opportunities for its portfolio assets.
The Company's common stock is traded under the symbol “POZN” on The NASDAQ
Global Market. For more detailed company information, including copies of this
and other press releases, please visit www.pozen.com.
POZEN is creating a portfolio of integrated aspirin therapies - the PA product
platform. The products in the PA portfolio are intended to significantly
reduce GI ulcers and other GI complications compared to taking enteric-coated
or plain aspirin alone.
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 administered orally once a day and an indication will be sought for
use for the secondary prevention of cardiovascular disease in patients at risk
for aspirin-induced gastric ulcers.
Proposed PA 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
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 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 Six Months Ended
June 30, June 30,
2013 2012 2013 2012
Royalty $ 1,651,000 $ 1,268,000 $ 3,066,000 $ 2,557,000
Licensing — 500,000 — 500,000
Total revenue 1,651,000 1,768,000 3,066,000 3,057,000
general and 3,713,032 4,070,707 7,347,076 9,718,630
Research and 1,941,346 2,874,068 5,525,286 6,978,514
operating 5,654,378 6,944,775 12,872,362 16,697,144
other income, 15,382 72,663 40,434 141,300
income tax (3,987,996 ) (5,104,112 ) (9,765,928 ) (13,498,844 )
Income tax — — — —
attributable $ (3,987,996 ) $ (5,104,112 ) $ (9,765,928 ) $ (13,498,844 )
diluted net $ (0.13 ) $ (0.17 ) $ (0.32 ) $ (0.45 )
Shares used in
diluted net 30,403,670 29,998,006 30,370,034 29,986,590
June 30, December 31,
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
LIABILITIES AND STOCKHOLDERS' EQUITY
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
Bill Hodges, 919-913-1030
Chief Financial Officer
Stephanie Bonestell, 919-913-1030
Manager, Investor Relations & Public Relations
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