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).
- 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.
- 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.
- Pfizer 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.
- 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.
- 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.
- 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 $1.0 billion in cumulative net sales, which royalty is set at 15%. Outside the United States, the royalty rate is 10%.
- We will also receive from Pfizer a supplemental royalty fee payment of 6.0% to 11.5% of net sales, depending on the range of total dollar sales in each year. This supplemental payment is equal to the full amount of our financial obligations to Durect Corporation (Nasdaq:DRRX), our exclusive supplier of certain excipients in REMOXY.
- Our development expenses for REMOXY and three other abuse-resistant pain medications that are in various stages of development, including hydrocodone, hydromorphone and oxymorphone, are reimbursed by Pfizer.
- Pain Therapeutics retains commercial rights to REMOXY and three other abuse-resistant drug candidates in Australia/New Zealand. We have not yet announced a market entry strategy for these territories.
|PAIN THERAPEUTICS, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
|Three Months Ended December 31,||Year Ended December 31,|
|Program fee revenue||$ 2,468||$ 2,724||$ 10,641||$ 10,897|
|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|
|Net loss||$ (1,796)||$ (391)||$ (3,446)||$ (2,613)|
|Net loss per share - basic and diluted||$ (0.04)||$ (0.01)||$ (0.08)||$ (0.06)|
|Weighted-average shares used in computing net loss per share - basic and diluted||44,903||44,671||44,753||44,160|
|CONDENSED BALANCE SHEETS|
|Cash, cash equivalents and marketable securities||$ 56,254||$ 98,131|
|Other current assets||253||358|
|Total current assets||56,507||98,489|
|Property and equipment, net||--||122|
|Total assets||$ 56,859||$ 98,963|
|Liabilities and stockholders' equity|
|Accounts payable and accrued development expenses||$ 1,290||$ 1,378|
|Deferred program fee revenue - current portion||7,832||10,897|
|Other accrued liabilities||877||997|
|Total current liabilities||9,999||13,272|
|Deferred program fee revenue - non-current portion||33,287||40,863|
|Accumulated other comprehensive income||4||128|
|Total stockholders' equity||13,136||44,393|
|Total liabilities and stockholders' equity||$ 56,859||$ 98,963|
|(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. firstname.lastname@example.org (512) 501-2450