Exclusive License Agreement for U.S. Rights to
PA8140/PA32540 Signed with Sanofi US
POZEN Inc. (NASDAQ:POZN), a pharmaceutical company
committed to transforming medicine that transforms lives, today
announced results for the third quarter ended September 30,
2013.
Recent Corporate Highlights
- In September, POZEN and Sanofi US
announced the signing of an exclusive license agreement for the
commercialization of PA8140/PA32540. Under the terms of the
agreement, Sanofi US will have exclusive rights to commercialize
all PA combinations that contain 325 mg or less of enteric-coated
aspirin in the United States. POZEN received an upfront payment of
$15 million and will be eligible for pre-commercial milestone
payments of up to $20 million and other future milestone payments
and royalties on product sales. The upfront payment will be
amortized over fifteen months starting in September 2013.Sanofi US
will have responsibility for all sales, marketing, ongoing
manufacturing and future development for the licensed PA products
in the U.S. POZEN will retain responsibility for obtaining approval
of the New Drug Application (NDA), after which time POZEN will
transfer the NDA to Sanofi US. The NDA was submitted in March 2013
and accepted for filing in May 2013 by the U.S. Food and Drug
Administration (FDA) and has a user fee action date of January 24,
2014.
- As part of POZEN’s ongoing interactions
and requests for information from the FDA during its review of the
NDA for PA8140/PA32540, the FDA has requested a teleconference,
which has been scheduled for mid-November. POZEN will discuss and
address the FDA’s request for information with respect to the
existing clinical pharmacology data on PA8140.
- POZEN is focusing its efforts on
obtaining FDA approval of PA8140/PA32540, transitioning all
know-how to Sanofi US, completing the remaining Phase 1 study and
MAA filing for PA10040, evaluating the possibility of a MAA filing
using existing data for the use of PA in secondary cancer
prevention, attempting to partner all un-partnered assets, and
reducing staff and expenses as warranted by business conditions. In
addition, POZEN’s management team and board of directors are
evaluating possible ways of returning value to shareholders,
including cash distributions of surplus corporate cash.
- Liz Cermak, Executive Vice President
and Chief Commercial Officer, has announced her retirement from
POZEN. Ms. Cermak led many facets of our PA program including
POZEN’s efforts to secure the best agreement possible for
shareholders with Sanofi US. POZEN will complete its commercial
obligations to Sanofi US before the end of the fourth quarter, thus
allowing Ms. Cermak the opportunity to retire at the end of the
year.
- In August, results of a POZEN-funded,
community based study, demonstrating that concomitant proton pump
inhibitor (PPI) therapy improves adherence in low-dose aspirin
(ASA) users, was presented at the European Society of Cardiology
Congress 2013 in Amsterdam.
- POZEN and AstraZeneca AB executed two
agreements in September relating to VIMOVO® (naproxen /
esomeprazole magnesium). An amendment to parties’ 2006 license and
collaboration agreement clarified the intellectual property
provisions of the agreement to expressly exclude products that
contain aspirin. The other agreement provided, among other things,
that in the event that AstraZeneca divests its rights to
commercialize VIMOVO in the US, AstraZeneca will be relieved of its
obligation to guarantee the performance of the acquiring
party.
- Q3 2013 global net sales of VIMOVO by
AstraZeneca, as defined under our agreement, were $23 million, up
72% vs. Q3 2012 and down 1% from Q2 2013. POZEN earned a royalty of
$1.6 million in Q3 2013.
Third Quarter Results
For the third quarter of 2013, POZEN reported revenue of $2.6
million compared to total revenue of $0.9 million for the third
quarter of 2012. Revenue for 2013 was comprised of the royalty for
sales of VIMOVO of $1.6 million and amortization of the upfront
payment for PA8140/PA32540 of $1.0 million. Revenue for 2012 came
entirely from the royalty for the sales of VIMOVO.
Operating expenses for the third quarter of 2013 totaled $7.4
million, as compared to $6.7 million for the comparable period in
2012. The increase in operating expenses in the third quarter of
2013 was primarily a result of one-time costs associated with the
PA8140/PA32540 agreement with Sanofi US totaling $1.6 million.
POZEN reported a net loss of ($4.8) million, or ($0.16) loss per
share for the third quarter of 2013, compared to a net loss of
($5.7) million, or ($0.19) per share, for the third quarter of
2012.
Nine Month Results
For the nine months ended September 30, 2012 and 2013, POZEN
reported revenue of $4.0 million and $5.6 million, respectively.
Revenue in 2012 included $3.5 million of VIMOVO royalty and $0.5
million of licensing revenue for MT400. Revenue in 2013 was
comprised of $4.6 million of VIMOVO royalty and $1.0 million of
amortization of the upfront payment for PA8140/PA32540.
Operating expenses for the nine months ended September 30, 2013
totaled $20.2 million, as compared to $23.4 million for the
comparable period in 2012. The decrease in operating expenses in
the nine months ended September 30, 2013 was primarily a result of
lower development and pre-commercialization costs for PA, partially
offset by one-time costs associated with the Sanofi US
agreement.
POZEN reported a net loss of ($14.5) million, or ($0.48) loss
per share for the nine months ended September 30, 2013, compared to
a net loss of ($19.2) million, or ($0.64) per share, for the nine
months ended September 30, 2012.
Balance Sheet
At September 30, 2013, cash and cash equivalents totaled $89.7
million, which is $2.4 million more than our balance at December
31, 2012.
Third Quarter Results Webcast
POZEN will host a webcast to present third quarter 2013 results
and management’s outlook on Wednesday, November 6, 2013 at 11:00
a.m. (ET). The webcast can be accessed live and will be available
for replay at www.pozen.com.
About POZEN
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 has
created 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.
About PA
POZEN has created a portfolio of investigational integrated
aspirin therapies - the PA product platform. The products in the PA
portfolio are being developed with the goal of significantly
reducing 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
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.
Proposed PA8140/PA32540 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.
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.
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, 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 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 further license our PA product candidates on terms and
timing acceptable to us, 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 for all expected
indications, 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®, our dependence
on Sanofi US for the sales and marketing of PA8140/PA32540 in the
United States, if approved, and our dependence on Patheon for the
manufacture of PA8140/PA32540; 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 June 30, 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.
POZEN Inc.
Statements of Operations
(Unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2013 2012 2013
2012 Revenue: Royalty revenue $
1,583,000 $ 940,000 $ 4,649,000 $ 3,497,000 Licensing revenue
1,000,000 — 1,000,000 500,000 Total revenue 2,583,000 940,000
5,649,000 3,997,000 Operating expenses: Selling, general and
administrative 5,182,501 4,444,194 12,529,577 14,162,824 Research
and development 2,181,689 2,256,450 7,706,975 9,234,964 Total
operating expenses 7,364,190 6,700,644 20,236,552 23,397,788 Other
income: Interest and other income, net 13,997 65,300 54,431 206,600
Loss before income tax benefit (4,767,193 ) (5,695,344 )
(14,533,121 ) (19,194,188 ) Income tax expense — — — —
Net loss attributable to common
stockholders
$ (4,767,193 ) $ (5,695,344 ) $ (14,533,121 ) $ (19,194,188 )
Basic and diluted net loss per common
share
$ (0.16 ) $ (0.19 ) $ (0.48 ) $ (0.64 )
Shares used in computing basic and
diluted net loss per common share
30,476,562 30,084,315 30,405,543 30,019,165
POZEN Inc.
Balance Sheets
(Unaudited)
September 30, December 31, 2013
2012 ASSETS Current assets: Cash and cash equivalents
$ 89,695,509 $ 68,416,308 Short-term investments — 18,898,136
Accounts receivable 1,583,000 1,352,000 Prepaid expenses and other
current assets 105,565 858,423 Total current assets 91,384,074
89,524,867 Equipment, net of accumulated depreciation 47,813 71,945
Total assets $ 91,431,887 $ 89,596,812
LIABILITIES
AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable
$ 984,539 $ 1,231,761 Accrued compensation 1,924,833 2,574,334
Accrued expenses 1,693,335 1,456,055 Deferred revenue 12,257,300
257,300 Total current liabilities 16,860,007 5,519,450 Long-term
liabilities: Deferred revenue 2,000,000 — Total liabilities
18,860,007 5,519,450 Total stockholders’ equity
72,571,880 84,077,362 Total liabilities and stockholders’ equity $
91,431,887 $ 89,596,812
POZEN Inc.Bill Hodges, 919-913-1030Chief Financial
OfficerorStephanie Bonestell, 919-913-1030Manager, Investor
Relations & Public Relations