AUSTIN, Texas, Oct. 31, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter and nine months ended September 30, 2013. Net loss was $762,000, or $0.02 per share in Q3 2013, compared to a net loss of $1,550,000, or $0.03 per share in Q3 2012. Cash and investments were $51.0 million at September 30, 2013. "We still expect our net cash usage to be under $10 million in CY2013," said Remi Barbier, Chairman, President & CEO. "Based on recent developments, we also believe Pfizer has a robust plan to resubmit the REMOXY ® NDA. Key elements of this plan include doing a bioequivalence study and an abuse-potential study using REMOXY, all of which we believe may result in a stream of technical milestones now through 2015." Q3 2013 Financial Detail
- Program fee revenue reflects the non-cash revenue we recognize from upfront program fees received in prior years.
- Research and development expenses decreased to $1.4 million in Q3 2013 from $2.4 million in Q3 2012 and to $3.8 million in the first nine months of 2013 from $5.5 million in the first nine months of 2012, primarily due to lower cash-based compensation and lower non-cash stock related compensation. Non-cash stock related research and development expenses decreased to $1.0 million in the first nine months of 2013 from $2.0 million in the first nine months of 2012.
- General and administrative expenses decreased to $1.3 million in Q3 2013 from $2.0 million in Q3 2012, and to $3.7 million in the first nine months of 2013 from $5.0 million in the first nine months of 2012, primarily due to lower cash-based compensation and lower non-cash stock related compensation. Non-cash stock related general and administrative expenses decreased to $1.3 million in the first nine months of 2013 from $2.0 million in the first nine months of 2012.
Pfizer, Inc. (NYSE:PFE) is our exclusive, worldwide commercial partner for REMOXY ® (oxycodone) Extended-Release Capsules CII, except as to Australia and New Zealand.REMOXY Deal Economics
- We are eligible to receive from Pfizer a $15.0 million payment upon FDA approval of REMOXY.
- After 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 $1.0 billion in cumulative net sales, which royalty is set at 15%. Outside the United States, the royalty rate is 10%.
- We will also receive from Pfizer a supplemental payment of 6.0% to 11.5% of net sales, depending on the range of total dollar sales in each year, covered by the strategic alliance. This supplemental payment is tied to the full amount of our financial obligations to Durect Corporation (Nasdaq:DRRX), our exclusive supplier of certain excipients in REMOXY.
- In October 2013, Pfizer returned to us all rights with respect to abuse-resistant formulations of hydrocodone, hydromorphone and oxymorphone. These drug assets now vest exclusively in PTI without any royalty or other obligation to Pfizer. We are free to develop and commercialize these assets on our own or with a licensee of our choice, and may do so without notice or approval from Pfizer. Investigational New Drug (IND) applications for all three drug assets are in place with FDA. We have not yet made a decision to develop or to out-license these three drug assets.
|PAIN THERAPEUTICS, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Program fee revenue||$ 1,958||$ 2,725||$ 5,875||$ 8,173|
|Research and development||1,444||2,379||3,766||5,504|
|General and administrative||1,290||2,001||3,647||4,975|
|Total operating expenses||2,734||4,380||7,413||10,479|
|Net loss||$ (762)||$ (1,550)||$ (1,471)||$ (1,652)|
|Net loss per share, basic and diluted||$ (0.02)||$ (0.03)||$ (0.03)||$ (0.04)|
|Weighted-average shares used in computing net loss per share, basic and diluted||45,037||44,601||44,990||44,703|
|CONDENSED BALANCE SHEETS|
|September 30, 2013||December 31, 2012 (1)|
|Cash, cash equivalents and marketable securities||$ 51,027||$ 56,254|
|Other current assets||389||253|
|Total current assets||51,416||56,507|
|Total assets||$ 51,756||$ 56,859|
|Liabilities and stockholders' equity|
|Accounts payable and accrued development expenses||$ 1,273||$ 1,290|
|Deferred program fee revenue - current portion||7,832||7,832|
|Other accrued liabilities||550||877|
|Total current liabilities||9,655||9,999|
|Deferred program fee revenue - non-current portion||27,412||33,287|
|Common Stock and additional paid-in-capital||151,373||148,783|
|Accumulated other comprehensive income||1||4|
|Total stockholders' equity||14,252||13,136|
|Total liabilities and stockholders' equity||$ 51,756||$ 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: For More Information Contact: Peter S. Roddy Vice President and Chief Financial Officer Pain Therapeutics, Inc. firstname.lastname@example.org (512) 501-2450