Pain Therapeutics Reports Q3 2012 Financial Results
On Track With Financial Guidance for 2012
AUSTIN, Texas, Nov. 8, 2012 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc.
(Nasdaq:PTIE) today reported financial results for the quarter and nine months
ended September 30, 2012. Net loss for Q3 2012 was $1.6 million, or $0.03 per
share, as compared to the net loss in Q3 2011 of $0.8 million, or $0.02 per
share. Net loss for the first nine months of 2012 was $1.7 million, or $0.04
per share, as compared to net loss for the first nine months of 2011 of $2.2
million, or $0.05 per share.
Cash and investments were $92.5 million at September 30, 2012.The Company has
no debt.Management continues to believe net cash usage for full-year 2012
will be under $10.0 million.
"Our financial strategy is to maintain tight fiscal discipline while awaiting
the resubmission of REMOXY to the FDA by our commercial partner, Pfizer," said
Remi Barbier, President & CEO."We believe this drug candidate is
well-partnered, has succeeded in a Phase III efficacy study, has published
results of abuse-resistance, has four issued patents and targets a large
marketplace.The value of these success factors may become more apparent as
Pfizer updates regulatory guidance for REMOXY in the first half of 2013."
Based on management's review of recent written correspondence between Pfizer
and the FDA, management believes Pfizer is well-positioned to address the
concerns described in the FDA's Complete Response Letter for REMOXY.
Q3 2012 Financial Detail
Research and development expenses increased to $2.4 million in Q3 2012 from
$2.0 million in Q3 2011, primarily due to higher non-cash stock-related
compensation costs. Research and development expenses decreased to $5.5
million in the first nine months of 2012 from $6.6 million in the first nine
months of 2011, primarily due to lower headcount and facilities costs.
General and administrative expenses increased to $2.0 million in Q3 2012 from
$1.8 million in Q3 2011, primarily due to higher non-cash stock-related
compensation costs. General and administrative expenses decreased to $5.0
million in the first nine months of 2012 from $5.1 million in the first nine
months of 2011, primarily due to lower headcount and facilities costs.
Our lead drug candidate is called REMOXY (oxycodone) Extended-Release Capsules
CII. REMOXY is an investigational drug with a unique, controlled release
formulation of oxycodone for patients with moderate-to-severe chronic
pain.REMOXY is designed to discourage common methods of tampering associated
with prescription analgesic misuse and abuse.
oPfizer is our exclusive, worldwide commercial partner for REMOXY and three
other abuse-resistant prescription pain medications (except in
oREMOXY received a Complete Response Letter in December 2008 and in June
2011.Pfizer has sole responsibility for addressing the concerns described
in the FDA's Complete Response Letter, at its own expense.
oOn November 1, 2012, Pfizer announced it plans to meet with the FDA in
March 2013 to discuss REMOXY.Pfizer also announced the initiation of a
new pharmacokinetic study with REMOXY.
REMOXY Deal Economics
*To date, we have received total cash payments of $185.0 million in program
fees and milestone payments under the strategic alliance with Pfizer in
connection with the development of REMOXY and three other abuse-resistant
*We are also eligible to receive up to an additional $120.0 million in
clinical/regulatory milestone payments, including a $15 million payment
upon FDA approval of REMOXY.
*Upon the commercial launch of REMOXY, we will receive from Pfizer a
royalty of 20% of net sales in the United States, except as to the first
$1.0 billion in cumulative net sales, which royalty is set at 15%. Outside
the United States, the royalty rate is 10%.
*We will also receive from Pfizer a supplemental royalty fee payment of
6.0% to 11.5% of net sales, depending on the range of total dollar sales
in each year. This supplemental payment is equal to the full amount of our
financial obligations to Durect Corporation (Nasdaq: DRRX), our exclusive
supplier of certain excipients in REMOXY.
*Our development expenses for REMOXY and three other abuse-resistant pain
medications that are in various stages of development, including
hydrocodone, hydromorphone and oxymorphone, are reimbursed by Pfizer.
*Pain Therapeutics retains commercial rights to REMOXY and three other
abuse-resistant drug candidates in Australia/New Zealand.We have not yet
announced a market entry strategy for these territories.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel
drugs.The FDA has not approved any of our drug candidates for commercial
sale. For more information, please visit www.paintrials.com.
Note Regarding Forward-Looking Statements: This press release contains
forward-looking statements for purposes of the Private Securities Litigation
Reform Act of 1995 (the "Act").Pain Therapeutics disclaims any intent or
obligation to update these forward-looking statements, and claims the
protection of the Safe Harbor for forward-looking statements contained in the
Act.Examples of such statements include, but are not limited to, any
statements relating to the size and potential markets for REMOXY, the
development and commercialization prospects of REMOXY, our projected net cash
usage for 2012, Pfizer's plans with respect to development of REMOXY,
potential future milestone payments and royalties based on revenue from
REMOXY, the potential development of other abuse resistant drug candidates,
funding obligations of Pfizer, or the benefits of REMOXY.Such statements are
based on management's current expectations, but actual results may differ
materially due to various factors. Such statements involve risks and
uncertainties, including, but not limited to, those risks and uncertainties
relating to difficulties or delays in obtaining regulatory approval of REMOXY
and in development, testing and pursuit of regulatory approval of our other
drug candidates, unexpected adverse side effects or inadequate therapeutic
efficacy of our drug candidates, difficulties or delays in commercialization
efforts with respect to our products, if any are approved for marketing, or
failure of such products to gain market acceptance, the uncertainty of patent
protection for our intellectual property or trade secrets, unanticipated
additional research and development and other costs, potential diversion of
resources from the pursuit of development and commercialization of drug
candidates subject to our strategic alliance with Pfizer as a result of the
acquisition of King Pharmaceuticals, Inc. by Pfizer, the potential for abuse
resistant pain medications or other competing products or therapies to be
developed by competitors and potential competitors or others and difficulties
resulting from, or risks associated with, pending litigation, including
diversion of resources and potential adverse judgments.For further
information regarding these and other risks related to the Company's business,
investors should consult the Company's filings with the Securities and
-Financial Tables Follow-
PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Nine months ended
September 30, 2012 September 30, 2012
Program fee revenue $2,725 $2,725 $8,173 $8,173
Collaboration revenue -- 24 249 564
Total revenue 2,725 2,749 8,422 8,737
Research and development 2,379 2,019 5,504 6,589
General and 2,001 1,753 4,975 5,078
Total operating expenses 4,380 3,772 10,479 11,667
Operating loss (1,655) (1,023) (2,057) (2,930)
Interest income 105 208 405 708
Net loss $(1,550) $(815) $(1,652) $(2,222)
Net loss per share, basic $(0.03) $(0.02) $(0.04) $(0.05)
used in computing net 44,601 44,631 44,703 43,987
loss per share, basic and
CONDENSED BALANCE SHEETS
September 30, December 31,
Cash, cash equivalents and $92,529 $98,131
Other current assets 378 358
Total current assets 92,907 98,489
Property and equipment, 352 474
net and other assets
Total assets $93,259 $98,963
Accounts payable and accrued $1,300 $1,378
Deferred program fee revenue - 10,897 10,897
Other accrued 1,603 997
Total current 13,800 13,272
Deferred program fee revenue - 32,690 40,863
Other liabilities 437 435
Total liabilities 46,927 54,570
Common Stock and
additional 180,187 176,470
Accumulated other 2 128
Accumulated deficit (133,857) (132,205)
Total stockholders' 46,332 44,393
Total liabilities and $93,259 $98,963
^(1) Derived from the Company's annual financial statements as of December 31,
2011, included in the Company's Annual Report on Form 10-K filed with the
Securities and Exchange Commission.
CONTACT: Peter S. Roddy
Vice President and Chief Financial Officer
Pain Therapeutics, Inc.
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