Cash Flow Positive in 2008
Remoxy(tm) NDA On-track for Q2 2008 Filing
Accelerated Growth of Biopharmaceutical Pipeline
SAN MATEO, Calif., Feb. 7, 2008 (PRIME NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for the year and fourth quarter ended December 31, 2007.
Net income for the year ended December 31, 2007 was $20.3 million, or $0.44 per diluted share, compared to net income of $6.2 million, or $0.14 per diluted share, for 2006. Net income for the quarter ended December 31, 2007 was $1.1 million, or $0.02 per diluted share, compared to a net loss of $5.7 million, or $0.13 per diluted share for the fourth quarter of 2006.
At December 31, 2007, the Company had cash, cash equivalents and marketable securities of $205.1 million.
"Our vision is to be a force for change in pain management," said Remi Barbier, Pain Therapeutics' president and chief executive officer. "We offer a variety of groundbreaking drug candidates in early and late-stages of development, coupled with tight fiscal discipline. This is our business model and it provided us with an extraordinary year of achievements in 2007. Now we're hungry for more. In 2008, we'll focus on executing our plan for revenue and earnings growth over the long term."
2008 Financial Guidance
* Pain Therapeutics anticipates being cash flow positive in 2008.
* Pain Therapeutics anticipates receiving $20.0 million of cash
milestone payments in 2008 under its strategic alliance with King
Pharmaceuticals, Inc., as follows:
* The Remoxy New Drug Application (NDA) filing remains on-track for
Q2 2008; acceptance of this NDA by the U.S. Food and Drug
Administration (FDA) triggers a $15.0 million cash milestone
payment from King Pharmaceuticals, Inc.
* Pain Therapeutics expects to file an Investigational New Drug
application (IND) for a new abuse-resistant opioid in 2008;
acceptance of this IND by the FDA triggers a $5.0 million cash
milestone payment from King Pharmaceuticals, Inc.
* Pain Therapeutics expects to accelerate the growth of its pipeline
of biopharmaceutical drugs. The Company anticipates spending $10.0
to $15.0 million developing biopharmaceutical products for
metastatic melanoma, hemophilia and other important disease areas.
All commercial rights to these biopharmaceutical drugs are owned
entirely by the Company.
* Pain Therapeutics has in place a stock buyback plan for up to $20.0
million of its common stock. In 2008, the Company may increase the
size of its buyback plan, depending on market conditions and other
factors.
2007 Financial Highlights
* Under our collaboration agreement, King reimburses our expenses
related to the development of Remoxy and other abuse-resistant
opioid painkillers, resulting in collaboration revenue.
Collaboration revenue for the year ended December 31, 2007 was
$42.7 million, compared to $22.7 million for the same period of
2006. Collaboration revenue in 2007 included approximately $10.4
million of costs incurred in 2006 that were reimbursed in the first
half of 2007. Collaboration revenue for the fourth quarter of 2007
was $10.5 million. In 2008, we expect to receive and recognize
collaboration revenue of $3.8 million for expenses we incurred in
2007.
* Research and development expenses for the fourth quarter ended
December 31, 2007 increased to $13.6 million from $13.3 million for
the same period of 2006. Research and development expenses for the
year ended December 31, 2007 increased to $47.7 million from $46.8
million for 2006. The increases are mostly due to increased
spending for Remoxy and melanoma. Research and development expenses
included non-cash stock-related compensation costs of $1.1 million
in the fourth quarter ended December 31, 2007 and $3.7 million in
the year ended December 31, 2007.
* General and administrative expenses increased to $2.1 million from
$2.0 million in the three months ended December 31, 2007 and 2006,
respectively, and to $8.1 million from $7.7 million in the year
ended December 31, 2007 and 2006, respectively. General and
administrative expenses included non-cash stock-related
compensation costs of $0.9 million in the three months ended
December 31, 2007 and $2.6 million in the year ended December 31,
2007.
* We have a stock buyback plan for up to $20.0 million of our common
stock. As of December 31, 2007, we have purchased $3.8 million of
our stock on the open market. We intend to hold repurchased shares
in treasury. The total number of shares to be purchased and the
timing of purchases will be based on several factors, including the
price of the common stock, general market conditions, corporate and
regulatory requirements and alternate investment opportunities.
This stock buyback program expires in March 2008 and may be
modified or discontinued at any time.
* We have not provided for income taxes for 2007 because we did not
have taxable income for the full fiscal year. Our income before
income taxes in 2007 includes program fee revenue. For tax
purposes, we recognized all of the related program fee revenue in
2006, which is the primary reason the Company did not have taxable
income in 2007.
* King made an upfront payment of $150.0 million in December 2005 as
part of our strategic alliance to develop Remoxy and other
abuse-resistant opioid painkillers. For accounting purposes, we
plan to recognize a portion of this cash payment as non-cash
"program fee revenue" each quarter over the estimated development
period. In Q4 2007, we changed our estimated development period to
Q3 2014, based on changes in the estimated timing of the completion
of development of the other abuse-resistant opioid painkillers.
Non-cash program fee revenue was $3.6 million in Q4 2007. Our
timetable for filing the NDA and commercialization for Remoxy is
not impacted by this change in estimate. We believe that we remain
on-track to file an NDA for Remoxy in Q2 2008.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In December 2007, we announced that Remoxy met the primary endpoint (p less than 0.01) of a pivotal Phase III study in over 400 patients with osteoarthritis; as a result, we plan to file an NDA for Remoxy in Q2 2008. We also have other drug candidates in clinical programs, including a novel radio-labeled monoclonal antibody to treat metastatic melanoma, PTI-202 and Oxytrex(tm). In addition, we are working on a new treatment for patients with hemophilia. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. 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, Inc. 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, scope or expected outcome of the Company's clinical development of its drug candidates, including filing an NDA for Remoxy in the second quarter of 2008, filing an IND for a new abuse-resistant opioid, the Company's expected pipeline, the Company's expected spending in 2008, including with respect to its pipeline development efforts, the Company's expected receipt and recognition of collaboration revenue, the time period for program fee revenue recognition, the potential milestone and other payments from King, including with respect to the expected NDA filing for Remoxy, the potential benefits of the Company's drug candidates. 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, regulatory approval, production and marketing of the Company's drug candidates and potential drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates and potential drug candidates that could slow or prevent regulatory filings, product approval or market acceptance (including the risk that current and past results of clinical trials and testing are not necessarily indicative of future results of clinical trials and testing), the uncertainty of patent protection for the Company's intellectual property or trade secrets, the Company's ability to obtain additional financing if necessary, unanticipated research and development and other costs, and the timing or receipt of payments from King. 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 Ended Year Ended
December 31, December 31,
------------------ ------------------
2007 2006 2007 2006
-------- -------- -------- --------
Revenue
Collaboration revenue $ 10,468 $ (214) $ 42,746 $ 22,717
Program fee revenue 3,587 6,550 23,238 26,201
Milestone revenue -- -- -- 5,000
-------- -------- -------- --------
Total revenue 14,055 6,336 65,984 53,918
Operating expenses
Research and development 13,559 13,290 47,730 46,803
General and administrative 2,134 1,963 8,085 7,668
-------- -------- -------- --------
Total operating expenses 15,693 15,253 55,815 54,471
-------- -------- -------- --------
Operating income (loss) (1,638) (8,917) 10,169 (553)
Interest and other income, net 2,769 2,552 10,136 9,668
-------- -------- -------- --------
Income (loss) before provision
for income taxes 1,131 (6,365) 20,305 9,115
Provision for (benefit from)
income taxes -- (653) -- 2,927
-------- -------- -------- --------
Net income (loss) $ 1,131 $ (5,712) $ 20,305 $ 6,188
======== ======== ======== ========
Net income (loss) per share
Basic $ 0.03 $ (0.13) $ 0.46 $ 0.14
======== ======== ======== ========
Diluted $ 0.02 $ (0.13) $ 0.44 $ 0.14
======== ======== ======== ========
Weighted-average shares used in
computing net income (loss)
per share
Basic 44,186 44,262 44,150 44,146
======== ======== ======== ========
Diluted 46,400 44,262 45,676 45,475
======== ======== ======== ========
PAIN THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
December 31,
----------------------
2007 2006(1)
---------- ----------
(Unaudited)
Assets
Current assets
Cash, cash equivalents and marketable
securities $ 205,071 $ 204,400
Other current assets 303 2,714
---------- ----------
Total current assets 205,374 207,114
Non-current assets
Property and equipment, net 1,607 1,267
Other assets 644 75
---------- ----------
Total assets $ 207,625 $ 208,456
========== ==========
Liabilities and stockholders' equity
Current liabilities
Accounts payable $ 3,624 $ 985
Accrued development expense 817 5,777
Deferred program fee revenue - current
portion 14,348 26,200
Income taxes payable -- 2,779
Other accrued liabilities 1,868 913
---------- ----------
Total current liabilities 20,657 36,654
Non-current liabilities
Deferred program fee revenue - non-current
portion 82,501 93,887
Other liabilities 553 --
---------- ----------
Total liabilities 103,711 130,541
---------- ----------
Stockholders' equity
Common stock 44 44
Additional paid-in-capital 221,415 214,749
Accumulated other comprehensive income (loss) 584 (372)
Accumulated deficit (118,129) (136,506)
---------- ----------
Total stockholders' equity 103,914 77,915
---------- ----------
Total liabilities and stockholders' equity $ 207,625 $ 208,456
========== ==========
(1) Derived from audited financial statements.