Pain Therapeutics Reports Q1 2013 Financial Results
AUSTIN, Texas, April 24, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc.
(Nasdaq:PTIE) today reported financial results for the quarter ended March 31,
2013. Net loss for Q1 2013 was $408,000, or $0.01 per share in Q1 2013,
compared to a net profit of $30,000, or $0.00 per share in Q1 2012.
Cash and investments were $54.4 million at March 31, 2013.We continue to
expect net cash usage for the first half of 2013 to be under $5.0 million.We
have no debt.
"Pfizer met with the FDA on March 28, 2013, to discuss REMOXY," said Remi
Barbier, Chairman, President & CEO."Shortly, we expect to receive written
information from Pfizer regarding the outcome of this meeting.I expect this
information may guide a timetable for the future of REMOXY."
Q1 2013 Financial Detail
oResearch and development expenses decreased to $1.2 million in Q1 2013
from $1.6 million in Q1 2012, primarily due to reduced headcount. Non-cash
stock related research and development expenses decreased to $0.3 million
in Q1 2013 from $0.5 million in Q1 2012.
oGeneral and administrative expenses decreased to $1.2 million in Q1 2013
from $1.5 million in Q1 2012, primarily due to reduced operating costs.
Non-cash stock related general and administrative expenses were $0.4
million in both Q1 2013 and Q1 2012.
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 drug misuse and abuse.
oPfizer, Inc. (NYSE:PFE) is our exclusive, worldwide commercial partner for
REMOXY and three other abuse-resistant prescription pain medications
(except in Australia/New Zealand).
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.
oSince 2011, Pfizer has conducted complex investigations on REMOXY,
including several pilot pharmacokinetic studies to assess modifications to
the REMOXY formulation.Based on Pfizer's extensive understanding of
REMOXY, we believe they have developed proposals to address all of the
concerns outlined in the June 2011 Complete Response Letter.Pfizer met
with the FDA in March to discuss these proposals.We have not yet received
minutes of Pfizer's recent meeting with the FDA.
REMOXY Deal Economics
*To date, we have received total cash payments of $185.0 million in program
fees and milestone payments under our strategic alliance with Pfizer.
*We are also eligible to receive from Pfizer up to an additional $120.0
million in clinical/regulatory milestone payments, including a $15.0
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 receipt of feedback from Pfizer about its meeting with
the FDA regarding REMOXY; the expected benefits and uses of such feedback; the
potential for Pfizer to address the issues outlined in the June 2011 Complete
Response Letter to the REMOXY NDA; the company's projected cash requirements
for the first half of 2013; potential future milestone payments and royalties
based on revenue from REMOXY; the potential development of other
abuse-resistant drug candidates; and funding obligations of Pfizer. 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, litigation and
other costs; the timing and receipt of funds from Pfizer; potential diversion
of resources from the pursuit of development and commercialization of drug
candidates subject to our strategic alliance with Pfizer; and the potential
for abuse-resistant pain medications or other competing products or therapies
to be developed by competitors and potential competitors or others.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 Exchange Commission.
– Financial Tables Follow –
PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three Months Ended March 31,
Program fee revenue $1,958 $2,724
Collaboration revenue -- 249
Total revenue 1,958 2,973
Research and development 1,183 1,609
General and administrative 1,218 1,512
Total operating expenses 2,401 3,121
Operating loss (443) (148)
Interest income 35 178
Net income (loss) $(408) $30
Net income (loss) per share, basic and $(0.01) $0.00
Weighted-average shares used in
computing net income (loss) per share
Basic 44,932 44,732
Diluted 44,932 44,756
CONDENSED BALANCE SHEETS
March 31, December 31,
Cash, cash equivalents and marketable $54,391 $56,254
Other current assets 127 253
Total current assets 54,518 56,507
Other assets 352 352
Total assets $54,870 $56,859
Liabilities and stockholders' equity
Accounts payable and accrued $748 $1,290
Deferred program fee revenue - current 7,832 7,832
Other accrued liabilities 1,114 877
Total current liabilities 9,694 9,999
Deferred program fee revenue - 31,329 33,287
Other liabilities 437 437
Total liabilities 41,460 43,723
Common Stock and additional 149,468 148,783
Accumulated other comprehensive income 1 4
Accumulated deficit (136,059) (135,651)
Total stockholders' equity 13,410 13,136
Total liabilities and stockholders' $54,870 $56,859
^(1) Derived from the Company's annual financial statements as of December 31,
2012, 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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