United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
February 5, 2009
Pain Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
000-29959 |
91-1911336 |
||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
2211 Bridgepointe Parkway, Suite 500, San Mateo, CA 94404
(Address of principal executive offices, including zip code)
(650) 624-8200
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): |
||
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |
Item 2.02. Results of Operations and Financial Condition.
On February 5, 2009 Pain Therapeutics, Inc. (the "Company") issued a press release announcing the Company's financial results for the three and twelve months ended December 31, 2008. A copy of the press release has been furnished as an exhibit to this report and is incorporated by reference herein.
The information in this Current Report on Form 8-K and in Exhibit 99.1 shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference into any registration statement or other document filed or furnished pursuant to the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such document.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits.
The following exhibit is furnished as part of this Current Report on Form 8-K.
Exhibit
Number
Description
99.1
Press Release of Pain Therapeutics, Inc. dated February 5, 2009.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Pain Therapeutics, Inc. |
||
| Dated: February 5, 2009 | /s/ PETER S. RODDY Peter S. Roddy Vice President & Chief Financial Officer |
EXHIBIT INDEX
| Exhibit Number |
Description | |
| 99.1 | Press Release of Pain Therapeutics, Inc. dated February 5, 2009. |
EXHIBIT 99.1
Pain Therapeutics Announces Year-End 2008 Financial Results, Outlines 2009 Business Priorities
, Feb. 5, 2009 (GLOBE NEWSWIRE) --
Net income of $0.35 per share for 2008
$190 Million of Cash on Hand, No Debt
Cash Requirements in 2009 Expected to be Under $10 Million
SAN MATEO, Calif., Feb. 5, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for the year ended December 31, 2008. The Company also provided an update on its cash position and outlined its business strategy for maintaining financial strength in 2009.
Net income for the year ended December 31, 2008 was $15.3 million, or $0.35 per diluted share, compared to net income of $20.3 million, or $0.44 per diluted share, for 2007. Net loss for the quarter ended December 31, 2008 was $1.4 million, or $0.03 per diluted share, compared to net income of $1.1 million, or $0.02 per diluted share for the fourth quarter of 2007.
At December 31, 2008, Pain Therapeutics had cash, cash equivalents and marketable securities of $190.1 million, no debt and approximately 42 million shares outstanding. The Company expects its cash requirements in 2009 will be under $10.0 million.
"We're bracing for a vital 2009," said Remi Barbier, Pain Therapeutics' chairman, president and chief executive officer. "We believe core strength in 2009 will be based on regulatory momentum with REMOXY(r) and clinical progress with the biotech side of Pain Therapeutics. We also recognize that financial wreckage has sent shock waves through every industry, ours included. In this environment, it's imperative to protect the strength of our balance sheet while supporting key science objectives in 2009."
2009 Financial and Operating Guidance
* Pain Therapeutics started 2009 with $190.1 million of cash
and investments and no debt.
* We expect cash requirements in 2009 will be under $10.0
million, which includes a significant investment in the
growth of our biotech pipeline. We retain commercial rights
to our entire biotech pipeline.
* Pursuant to the terms of a strategic alliance, our commercial
partner, King Pharmaceuticals, Inc., is obligated to fund
development expenses incurred by us for REMOXY and three
other abuse-resistant pain medications. Upon approval,
Pain Therapeutics will receive 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%.
* The U.S. Food and Drug Administration (FDA) believes
additional non-clinical data will be required to support the
approval of REMOXY. The FDA has not requested or recommended
additional clinical efficacy studies prior to approval. We
plan to meet with the FDA in Q2 2009. We believe this FDA
meeting will provide us with a more reliable context in which
to make projections about REMOXY.
* A monoclonal antibody program, developed at Albert Einstein
College of Medicine, is aimed at treating patients with
late-stage melanoma. We expect to complete a second Phase
I study with this technology in 2009. We are also exploring
the use of similar technology to treat other important
disease areas. This drug asset is unpartnered.
* A gene transfer program, developed at Stanford University,
is aimed at correcting an underlying genetic defect in
patients with hemophilia. We expect to complete a significant
animal study with this technology in 2009. We are also
planning a first-in-human clinical study with this
technology in 2009. This drug asset is unpartnered.
* In general, our R&D goals in 2009 will be to continue to
focus on clinical stage drugs that can benefit from our core
expertise in drug development, to outsource certain functions
that permit the efficient deployment of our resources and to
develop promising but unpartnered biotech assets.
2008 Financial Highlights
* Milestone revenue of $20.0 million for 2008 included a
$15.0 million milestone payment from King related to the
acceptance by the FDA of the New Drug Application for REMOXY
and a $5.0 million milestone payment from King related to
the acceptance by the FDA of an investigational new drug
application for PTI-721.
* Collaboration revenue for 2008 was $29.4 million, compared
to $42.7 million for 2007 and reflects reimbursement of our
development expenses under our strategic alliance with King.
* Research and development expenses for 2008 decreased to
$45.8 million from $47.7 million for 2007. Research and
development expenses for the fourth quarter of 2008 decreased
to $9.2 million from $13.6 million for the fourth quarter of
2007. These decreases were 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 $6.1 million for 2008 and $3.7 million
for 2007.
* General and administrative expenses for 2008 increased to
$9.2 million from $8.1 million for 2007. This increase was
mostly due to increased non-cash stock-related compensation
costs. General and administrative expenses included non-cash
stock-related compensation costs of $4.1 million for 2008
and $2.6 million for 2007.
* Our income tax benefit for 2008 was $0.6 million, primarily
because of the expected value of our tax credits and other
tax carry forwards.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, the Company has three drug candidates in clinical programs, including a novel radio-labeled monoclonal antibody to treat metastatic melanoma, as well as PTI-202 and PTI-721. Pain Therapeutics is also working on a new treatment for patients with hemophilia.
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, statements related to the development of REMOXY, including the timing and expected utility of a proposed meeting with the FDA; clinical development of other product candidates, including the timing of completion of clinical trials and animal studies for melanoma and hemophilia, respectively, and the initiation of clinical trials in hemophilia; and cash requirements for 2009 and potential uses of such cash. 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 obtaining regulatory approval for the Company's drug candidates, development and testing of the Company's drug candidates, including the risk of being required by regulatory authorities to conduct unanticipated additional clinical and studies or submit additional data, 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 research and development and other costs and the timing and receipt of funds from the Company's commercial partner for REMOXY, the potential for abuse and misuse 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.
CONTACT: Pain Therapeutics, Inc.
Christi Waarich, Senior Manager of Investor Relations
650-645-1924
cwaarich@paintrials.com