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
- Research 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.
- General 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.
- Pfizer, Inc. (NYSE:PFE) is our exclusive, worldwide commercial partner for REMOXY and three other abuse-resistant prescription pain medications (except in Australia/New Zealand).
- 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.
- Since 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.
- 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 $1.0 billion in cumulative net sales, which royalty is set at 15%. Outside the United States, the royalty rate is 10%.
- We will also receive from Pfizer a supplemental royalty fee payment of 6.0% to 11.5% of net sales, depending on the range of total dollar sales in each year. This supplemental payment is equal to the full amount of our financial obligations to Durect Corporation (Nasdaq:DRRX), our exclusive supplier of certain excipients in REMOXY.
- Our development expenses for REMOXY and three other abuse-resistant pain medications that are in various stages of development, including hydrocodone, hydromorphone and oxymorphone, are reimbursed by Pfizer.
- Pain Therapeutics retains commercial rights to REMOXY and three other abuse-resistant drug candidates in Australia/New Zealand. We have not yet announced a market entry strategy for these territories.
|PAIN THERAPEUTICS, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
|Three Months Ended March 31,|
|Program fee revenue||$ 1,958||$ 2,724|
|Research and development||1,183||1,609|
|General and administrative||1,218||1,512|
|Total operating expenses||2,401||3,121|
|Net income (loss)||$ (408)||$ 30|
|Net income (loss) per share, basic and diluted||$ (0.01)||$ 0.00|
|Weighted-average shares used in computing net income (loss) per share|
|CONDENSED BALANCE SHEETS|
|March 31, 2013||December 31, 2012 (1)|
|Cash, cash equivalents and marketable securities||$ 54,391||$ 56,254|
|Other current assets||127||253|
|Total current assets||54,518||56,507|
|Total assets||$ 54,870||$ 56,859|
|Liabilities and stockholders' equity|
|Accounts payable and accrued development expenses||$ 748||$ 1,290|
|Deferred program fee revenue - current portion||7,832||7,832|
|Other accrued liabilities||1,114||877|
|Total current liabilities||9,694||9,999|
|Deferred program fee revenue - non-current portion||31,329||33,287|
|Common Stock and additional paid-in-capital||149,468||148,783|
|Accumulated other comprehensive income||1||4|
|Total stockholders' equity||13,410||13,136|
|Total liabilities and stockholders' equity||$ 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. firstname.lastname@example.org (512) 501-2450