Pain Therapeutics Reports 2012 Financial Results
Pain Therapeutics Reports 2012 Financial Results
Innovation, Disciplined Spending Expected in 2013
AUSTIN, Texas, Feb. 6, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc.
(Nasdaq:PTIE) today reported financial results for the full year ended
December 31, 2012. Net loss was $3.4 million in 2012, or $0.08 per share,
compared to a net loss of $2.6 million in 2011, or $0.06 per share.
"We are excited by the prospect of having important regulatory readouts on
REMOXY^® in 2013," said Remi Barbier, Chairman, President & CEO. "In the
interim, we'll maintain our existing corporate strategy to spend modestly and
to keep innovation at the top of our agenda."
At December 31, 2012, cash and equivalents were $56.3 million. The Company has
no debt. Management expects net cash usage for the first half of 2013 to be
under $5.0 million.
2012 Financial Detail
* In December 2012, Pain Therapeutics completed a special nondividend
distribution to shareholders totaling $34.0 million, or $0.75 per share.
* Revenue decreased to $10.9 million in 2012 from $11.5 million in 2011,
primarily due to lower collaboration revenue from reimbursements of
research and development expenses under our collaboration agreement with
Pfizer, Inc. (NYSE:PFE).
o Research and development expenses decreased to $7.6 million in 2012 from
$8.3 million in 2011, primarily due to lower headcount and
facilities-related costs. Research and development expenses included $3.2
million in non-cash stock related compensation costs in 2012 (including
$0.8 million related to the nondividend distribution in December 2012) and
$2.7 million in 2011.
o General and administrative expenses increased to $7.2 million in 2012 from
$6.7 million in 2011, primarily due to higher non-cash stock related
compensation costs, offset in part by lower headcount and
facilities-related costs. General and administrative expenses included
$3.4 million in non-cash stock related compensation costs in 2012
(including $1.0 million related to the nondividend distribution in
December 2012) and $2.8 million in 2011.
About REMOXY
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.
o Pfizer is our exclusive, worldwide commercial partner for REMOXY and three
other abuse-resistant prescription pain medications (except in
Australia/New Zealand).
o REMOXY 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.
REMOXY Deal Economics
o To date, we have received total cash payments of $185.0 million in program
fees and milestone payments under our strategic alliance with Pfizer in
connection with the development of REMOXY and three other abuse-resistant
drug candidates.
o We are also eligible to receive up to an additional $120.0 million in
clinical/regulatory milestone payments, including a $15.0 million payment
upon FDA approval of REMOXY.
o 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%.
o 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.
o 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.
o 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 potential regulatory readouts or other regulatory
feedback regarding REMOXY development; 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.
PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Year Ended December 31,
December 31,
2012 2011 2012 2011^(1)
Revenue
Program fee revenue $ 2,468 $ 2,724 $ 10,641 $ 10,897
Collaboration revenue -- 23 249 587
Total revenue 2,468 2,747 10,890 11,484
Operating expenses
Research and development 2,101 1,711 7,605 8,300
General and administrative 2,209 1,620 7,182 6,698
Total operating expenses 4,310 3,331 14,787 14,998
Operating loss (1,842) (584) (3,897) (3,514)
Interest income 46 193 451 901
Net loss $ (1,796) $ (391) $ (3,446) $ (2,613)
Net loss per share - basic $ (0.04) $ (0.01) $ (0.08) $ (0.06)
and diluted
Weighted-average shares used
in computing net loss per 44,903 44,671 44,753 44,160
share - basic and diluted
CONDENSED BALANCE SHEETS
December 31,
2012 2011^(1)
(Unaudited)
Assets
Current assets
Cash, cash equivalents and marketable $ 56,254 $ 98,131
securities
Other current assets 253 358
Total current assets 56,507 98,489
Non-current assets
Property and equipment, net -- 122
Other assets 352 352
Total assets $ 56,859 $ 98,963
Liabilities and
stockholders' equity
Current liabilities
Accounts payable and accrued development $ 1,290 $ 1,378
expenses
Deferred program fee revenue - current 7,832 10,897
portion
Other accrued liabilities 877 997
Total current liabilities 9,999 13,272
Non-current liabilities
Deferred program fee revenue - 33,287 40,863
non-current portion
Other liabilities 437 435
Total liabilities 43,723 54,570
Stockholders' equity
Common stock 45 45
Additional paid-in-capital 148,738 176,425
Accumulated other 4 128
comprehensive income
Accumulated deficit (135,651) (132,205)
Total stockholders' equity 13,136 44,393
Total liabilities and $ 56,859 $ 98,963
stockholders' equity
(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.
proddy@paintrials.com
(512) 501-2450
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