- REMOXY® NDA Resubmission Still Anticipated Q4 2010 -
- Cash Distribution of $2.00 Per Share Payable to Shareholders in December 2010 -
SAN MATEO, Calif., Oct. 28, 2010 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for its third quarter of fiscal year 2010.
"We reported today another solid quarter as we prepare for our next phase of growth", said Remi Barbier, Chairman, President & CEO of Pain Therapeutics. "We continue to believe REMOXY represents the rare combination of a well-partnered, late-stage drug asset with a unique profile, and whose clinical efficacy has been substantially de-risked."
Third Quarter Financial Results
Our lead drug candidate, REMOXY, is a strong painkiller with a unique abuse-resistant formulation designed to reduce potential risks of intentional abuse or accidental misuse. REMOXY and three other abuse-resistant pain medications are being developed pursuant to our strategic alliance with King. King has sole responsibility for the commercialization of REMOXY worldwide, except for Australia and New Zealand.
Our corporate strategy is to spend carefully but to keep innovation at the top of our agenda. In Q3 2010, we continued to make disciplined investments in two important disease areas - melanoma and hemophilia. We own commercial rights to all of our drug candidates in hematology/oncology.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, we have three other drug candidates in clinical programs. This includes a novel monoclonal antibody-based treatment against metastatic melanoma. We are also developing a new treatment for patients with hemophilia, a genetic disorder in which patients are unable to stop bleeding. For more information about us, please visit www.paintrials.com.
The term "abuse-resistant" as used in this announcement is not intended to designate an indication or a medical claim but rather a general description of agents designed to address the misuse, abuse and diversion of opioids. The FDA has not approved any of our drug candidates for commercial sale.
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 timing of King's resubmission of the NDA for REMOXY in Q4 2010; the benefits to the commercialization of REMOXY, if approved, that may result from the completion of the Pfizer's announced acquisition of King; our expected receipt of milestone payments or other revenue under our collaboration with King; our expected net cash burn rate for 2010; the tax treatment of the special nondividend distribution; and 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 development, testing and pursuit of regulatory approval of the Company's drug candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates; the uncertainty of delay or abandonment of the announced acquisition of King by Pfizer; the uncertainty of patent protection for the Company's intellectual property or trade secrets; unanticipated additional research and development and other costs; the timing and receipt of funds from King; the potential for abuse resistant pain medications to be developed by competitors and potential competitors to the Company; and the potential for Pfizer, if the acquisition of King is completed, to hold rights to products or product candidates that may be competitive to REMOXY. 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)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Program fee revenue||$ 2,724||$ 3,587||$ 7,772||$ 10,761|
|Research and development||2,360||4,521||7,736||17,247|
|General and administrative||2,107||1,530||5,256||4,675|
|Total operating expenses||4,467||6,051||12,992||21,922|
|Loss before benefit from income taxes||(1,028)||(1,675)||(2,852)||(3,855)|
|Benefit from income taxes||--||(363)||--||(685)|
|Net loss||$ (1,028)||$ (1,312)||$ (2,852)||$ (3,170)|
|Net loss per share - basic and diluted||$ (0.02)||$ (0.03)||$ (0.07)||$ (0.08)|
|Weighted-average shares used in computing|
|net loss per share - basic and diluted||42,703||42,201||42,593||42,143|
|CONDENSED BALANCE SHEETS|
|September 30,||December 31,|
|Cash, cash equivalents and marketable securities||$ 179,742||$ 175,759|
|Other current assets||286||$ 2,712|
|Total current assets||180,028||178,471|
|Property and equipment, net||340||517|
|Total assets||$ 180,794||$ 182,005|
|Liabilities and stockholders' equity|
|Accounts payable and accrued development expenses||$ 1,361||$ 2,538|
|Deferred program fee revenue - current portion||10,897||14,348|
|Other accrued liabilities||2,431||1,625|
|Total current liabilities||14,689||18,511|
|Deferred program fee revenue - non-current portion||54,484||53,805|
|Accumulated other comprehensive income||693||347|
|Total stockholders' equity||111,191||108,252|
|Total liabilities and stockholders' equity||$ 180,794||$ 182,005|
|(1) Derived from the Company's annual financial statements as of December 31, 2009, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission.|
CONTACT: Pain Therapeutics, Inc. Judy Ishida, Administrative Manager 650-645-1924 IR@paintrials.com
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