Pain Therapeutics Reviews Mid-Year Progress, Reports Second Quarter 2009 Financial Results
- Hemophilia and Melanoma Data Expected by Year End - - Net Loss for the Quarter Ended June 30, 2009 was $34,000 - - $182.2 Million of Cash, or $4.33 Cash per Share, No Debt as of June 30, 2009 -
SAN MATEO, Calif., Aug. 4, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reviewed mid-year progress with its drug candidates and reported financial results for the quarter ended June 30, 2009.
"2009 is shaping up to be a year of significant progress across our entire business," said Remi Barbier, President and Chief Executive Officer of Pain Therapeutics. "By year end 2009, we expect to announce top-line results from on-going studies with our drug candidates in two important disease areas - hemophilia and melanoma. Financially, we remain committed to a strong balance sheet and a modest cash burn rate, while we wait for King Pharmaceuticals, Inc., our commercial partner on abuse-resistant pain medications, to re-submit the NDA for Remoxy(r) in 2010."
Net loss for the quarter ended June 30, 2009 was $34,000, or $0.00 per share, compared to net loss of $1.0 million, or $0.02 per share, for the second quarter of 2008. Net loss for the six months ended June 30, 2009 was $1.9 million, or $0.04 per share, compared to net income of $1.5 million, or $0.04 per share, for the six months ended June 30, 2008.
Pain Therapeutics had cash, cash equivalents and marketable securities of $182.2 million, or about $4.33 cash per share, and no debt as of June 30, 2009.
Remoxy Remains Top Priority
Pain Therapeutics remains committed to the regulatory success of Remoxy, our lead drug candidate. Remoxy is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use. We are developing Remoxy, and other abuse-resistant painkillers, with King Pharmaceuticals, Inc. We 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.
* Pursuant to the terms of a strategic alliance, King funds all development expenses incurred by us for Remoxy and three other abuse-resistant pain medications. * From 2005 to 2008, we and King jointly managed a Phase III clinical program and a New Drug Application (NDA) for Remoxy. In mid-2008, the U.S. Food and Drug Administration (FDA) accepted the Remoxy NDA with Priority Review. * In December 2008, we received from the FDA a Complete Response Letter which indicated additional non-clinical data is required to support the approval of Remoxy. The FDA has not requested or recommended additional clinical efficacy studies prior to approval. * In March 2009, King assumed sole responsibility for the regulatory approval of Remoxy. This shift of responsibility does not change the economic terms of our strategic alliance with King. * In July 2009, King met with the FDA to discuss Remoxy. As a result of this meeting, King anticipates a resubmission of the Remoxy NDA in 2010. * Upon FDA approval of Remoxy, we will receive from King a $15.0 million cash milestone payment and a running royalty equal to 20% of net sales of drugs developed under this strategic alliance, except as to the first $1.0 billion in cumulative net sales, which royalty is set at 15%.
Broad Commitment to Biotechnology
Our corporate strategy is to spend carefully but to keep innovation at the top of our agenda. We are making disciplined investments focused on advancing novel drugs in two important disease areas - hemophilia and melanoma. We own all commercial rights to our novel drug candidates. We expect to announce new data in both disease areas by year end 2009.
* A radio-labeled monoclonal antibody program, developed at Albert Einstein College of Medicine, is aimed at treating patients with late-stage (metastatic) melanoma. This drug is called PTI-188. * In 2008, we completed a first-in-man clinical study with PTI-188. In this study, researchers in Israel administered PTI-188 to 12 patients diagnosed with metastatic melanoma. Encouraging data were observed, and later published at the 2008 Meeting of the Society for Nuclear Medicine. * In May 2009, we announced the initiation of a new Phase I study in metastatic melanoma in Israel using PTI-188. This study is on-going. Thus far, researchers have treated two cohorts of patients. We expect to enroll a third cohort of patients in this study by year end 2009. * We have a gene transfer program, developed at Stanford University, aimed at correcting an underlying genetic defect in patients with hemophilia. Importantly, no viral vector is utilized. We expect to complete a significant pre-clinical study with this technology by year end 2009.
Second Quarter Financial Results
* Collaboration revenue for Q2 2009 was $2.6 million, compared to $7.0 million for Q2 2008 and reflects reimbursement of our development expenses under our strategic alliance with King. * Research and development expenses for Q2 2009 decreased to $5.1 million from $11.2 million for Q2 2008. This decrease was mostly due to decreased spending for Remoxy and the other abuse-resistant product candidates under our strategic alliance with King. Research and development expenses included non-cash stock-related compensation costs of $0.9 million for Q2 2009 and $1.0 million for Q2 2008. * General and administrative expenses for Q2 2009 decreased to $1.4 million from $1.9 million for Q2 2008. This decrease was mostly due to lower operating costs. General and administrative expenses included non-cash stock-related compensation costs of $0.7 million for each of Q2 2009 and Q2 2008. * Interest income for Q2 2009 decreased to $0.2 million from $1.5 million in Q2 2008. This decrease was due to decreases in interest rates on our investments in marketable securities.
Updated 2009 Financial Guidance
This section contains forward-looking guidance about the financial outlook for Pain Therapeutics, Inc.
We are updating financial guidance for the full year 2009. Based primarily on decreases in interest rates on our investments in marketable securities, we believe our net cash requirements for the full year 2009 will be about $12 million, up from previous estimates of $10 to $11 million.
"We continue to invest in the growth of our biotech pipeline, while recognizing the need to balance these investments with respect to our financial profile," said Pete Roddy, Vice President and Chief Financial Officer of Pain Therapeutics.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. Our lead drug candidate, Remoxy(r), is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use. We are also developing novel drugs in the area of hematology/oncology. We have in clinical development a monoclonal antibody to treat metastatic melanoma, a deadly form of skin cancer. We also have in pre-clinical development a drug to treat hemophilia, a genetic disorder in which patients are unable to stop bleeding. 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 timing of King's resubmission of the NDA for Remoxy in 2010; the cash requirements of the Company for 2009 and expected uses of such cash; expected timing of commencement or completion of clinical trials and non-clinical studies; and the Company's expected receipt and recognition of collaboration revenue, including reimbursement of the Company's ongoing development activities under the collaboration with King. 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 (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets, unanticipated additional research and development and other costs and the timing and receipt of funds from the Company's commercial partner, the potential for abuse resistant pain medications to be developed by competitors and potential competitors to the Company. 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 Six Months Ended June 30, Ended June 30, ------------------ ------------------ 2009 2008 2009 2008 ------- ------- ------- -------- Revenue Collaboration revenue $ 2,649 $ 6,960 $ 5,897 $ 18,012 Program fee revenue 3,587 3,587 7,174 7,174 ------- ------- ------- -------- Total revenue 6,236 10,547 13,071 25,186 Operating expenses Research and development 5,090 11,215 12,726 23,699 General and administrative 1,414 1,896 3,145 3,716 ------- ------- ------- -------- Total operating expenses 6,504 13,111 15,871 27,415 ------- ------- ------- -------- Operating loss (268) (2,564) (2,800) (2,229) Interest income 233 1,539 620 3,774 ------- ------- ------- -------- Income (loss) before benefit from income tax (35) (1,025) (2,180) 1,545 Benefit from income taxes (1) -- (322) -- ------- ------- ------- -------- Net income (loss) $ (34) $(1,025) $(1,858) $ 1,545 ======= ======= ======= ======== Net income (loss) per share Basic $ (0.00) $ (0.02) $ (0.04) $ 0.04 ======= ======= ======= ======== Diluted $ (0.00) $ (0.02) $ (0.04) $ 0.04 ======= ======= ======= ======== Weighted-average shares used in computing net income (loss) per share Basic 42,137 41,579 42,114 42,714 ======= ======= ======= ======== Diluted 42,137 41,579 42,114 43,974 ======= ======= ======= ======== CONDENSED BALANCE SHEETS June 30, Dec. 31, 2009 2008 (1) --------- --------- (Unaudited) Assets Current assets Cash, cash equivalents and marketable securities $ 182,217 $ 190,095 Other current assets 2,038 541 --------- --------- Total current assets 184,255 190,636 Non-current assets Property and equipment, net 641 774 Other assets 1,420 2,026 --------- --------- Total assets $ 186,316 $ 193,436 ========= ========= Liabilities and stockholders' equity Current liabilities Accounts payable and accrued development expense $ 1,466 $ 3,245 Deferred program fee revenue - current portion 14,348 14,348 Other accrued liabilities 2,255 2,521 --------- --------- Total current liabilities 18,069 20,114 Non-current liabilities Deferred program fee revenue - non-current portion 60,980 68,154 Other liabilities 1,414 882 --------- --------- Total liabilities 80,463 89,150 --------- --------- Stockholders' equity Common stock 42 42 Additional paid-in-capital 221,672 218,021 Accumulated other comprehensive income 99 325 Accumulated deficit (115,960) (114,102) --------- --------- Total stockholders' equity 105,853 104,286 --------- --------- Total liabilities and stockholders' equity $ 186,316 $ 193,436 ========= ========= (1) Derived from the Company's annual financial statements as of December 31, 2008, 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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