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)
August 4, 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 August 4, 2009 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit 99.1. Press release dated August 4, 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: August 4, 2009 | /s/ PETER S. RODDY Peter S. Roddy Vice President & Chief Financial Officer |
| Exhibit Index | ||
| 99.1 | Press release dated August 4, 2009 | |
EXHIBIT 99.1
Pain Therapeutics Reviews Mid-Year Progress, Reports Second Quarter 2009 Financial Results
- Hemophilia and Melanoma Data Expected by Year End -
- Net Loss for the Quarter Ended June 30, 2009 was $34,000 -
- $182.2 Million of Cash, or $4.33 Cash per Share, No Debt as
of June 30, 2009 -
SAN MATEO, Calif., Aug. 4, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reviewed mid-year progress with its drug candidates and reported financial results for the quarter ended June 30, 2009.
"2009 is shaping up to be a year of significant progress across our entire business," said Remi Barbier, President and Chief Executive Officer of Pain Therapeutics. "By year end 2009, we expect to announce top-line results from on-going studies with our drug candidates in two important disease areas - hemophilia and melanoma. Financially, we remain committed to a strong balance sheet and a modest cash burn rate, while we wait for King Pharmaceuticals, Inc., our commercial partner on abuse-resistant pain medications, to re-submit the NDA for Remoxy(r) in 2010."
Net loss for the quarter ended June 30, 2009 was $34,000, or $0.00 per share, compared to net loss of $1.0 million, or $0.02 per share, for the second quarter of 2008. Net loss for the six months ended June 30, 2009 was $1.9 million, or $0.04 per share, compared to net income of $1.5 million, or $0.04 per share, for the six months ended June 30, 2008.
Pain Therapeutics had cash, cash equivalents and marketable securities of $182.2 million, or about $4.33 cash per share, and no debt as of June 30, 2009.
Remoxy Remains Top Priority
Pain Therapeutics remains committed to the regulatory success of Remoxy, our lead drug candidate. Remoxy is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use. We are developing Remoxy, and other abuse-resistant painkillers, with King Pharmaceuticals, Inc. We believe Remoxy represents the rare combination of a well-partnered, late-stage drug asset with a unique profile, and whose clinical efficacy has been substantially de-risked.
* Pursuant to the terms of a strategic alliance, King funds
all development expenses incurred by us for Remoxy and three
other abuse-resistant pain medications.
* From 2005 to 2008, we and King jointly managed a Phase III
clinical program and a New Drug Application (NDA) for Remoxy.
In mid-2008, the U.S. Food and Drug Administration (FDA)
accepted the Remoxy NDA with Priority Review.
* In December 2008, we received from the FDA a Complete
Response Letter which indicated additional non-clinical data
is required to support the approval of Remoxy. The FDA has
not requested or recommended additional clinical efficacy
studies prior to approval.
* In March 2009, King assumed sole responsibility for the
regulatory approval of Remoxy. This shift of responsibility
does not change the economic terms of our strategic alliance
with King.
* In July 2009, King met with the FDA to discuss Remoxy. As
a result of this meeting, King anticipates a resubmission
of the Remoxy NDA in 2010.
* Upon FDA approval of Remoxy, we will receive from King a
$15.0 million cash milestone payment and 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%.
Broad Commitment to Biotechnology
Our corporate strategy is to spend carefully but to keep innovation at the top of our agenda. We are making disciplined investments focused on advancing novel drugs in two important disease areas - hemophilia and melanoma. We own all commercial rights to our novel drug candidates. We expect to announce new data in both disease areas by year end 2009.
* A radio-labeled monoclonal antibody program, developed at
Albert Einstein College of Medicine, is aimed at treating
patients with late-stage (metastatic) melanoma. This drug
is called PTI-188.
* In 2008, we completed a first-in-man clinical study with
PTI-188. In this study, researchers in Israel administered
PTI-188 to 12 patients diagnosed with metastatic melanoma.
Encouraging data were observed, and later published at the
2008 Meeting of the Society for Nuclear Medicine.
* In May 2009, we announced the initiation of a new Phase I
study in metastatic melanoma in Israel using PTI-188. This
study is on-going. Thus far, researchers have treated two
cohorts of patients. We expect to enroll a third cohort of
patients in this study by year end 2009.
* We have a gene transfer program, developed at Stanford
University, aimed at correcting an underlying genetic defect
in patients with hemophilia. Importantly, no viral vector
is utilized. We expect to complete a significant pre-clinical
study with this technology by year end 2009.
Second Quarter Financial Results
* Collaboration revenue for Q2 2009 was $2.6 million, compared
to $7.0 million for Q2 2008 and reflects reimbursement of
our development expenses under our strategic alliance with
King.
* Research and development expenses for Q2 2009 decreased to
$5.1 million from $11.2 million for Q2 2008. This decrease
was 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 $0.9
million for Q2 2009 and $1.0 million for Q2 2008.
* General and administrative expenses for Q2 2009 decreased
to $1.4 million from $1.9 million for Q2 2008. This decrease
was mostly due to lower operating costs. General and
administrative expenses included non-cash stock-related
compensation costs of $0.7 million for each of Q2 2009
and Q2 2008.
* Interest income for Q2 2009 decreased to $0.2 million from
$1.5 million in Q2 2008. This decrease was due to decreases
in interest rates on our investments in marketable securities.
Updated 2009 Financial Guidance
This section contains forward-looking guidance about the financial outlook for Pain Therapeutics, Inc.
We are updating financial guidance for the full year 2009. Based primarily on decreases in interest rates on our investments in marketable securities, we believe our net cash requirements for the full year 2009 will be about $12 million, up from previous estimates of $10 to $11 million.
"We continue to invest in the growth of our biotech pipeline, while recognizing the need to balance these investments with respect to our financial profile," said Pete Roddy, Vice President and Chief Financial Officer of Pain Therapeutics.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. Our lead drug candidate, Remoxy(r), is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use. We are also developing novel drugs in the area of hematology/oncology. We have in clinical development a monoclonal antibody to treat metastatic melanoma, a deadly form of skin cancer. We also have in pre-clinical development a drug to treat hemophilia, a genetic disorder in which patients are unable to stop bleeding. The FDA has not approved any of our drug candidates for commercial sale.
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, any statements relating to the timing of King's resubmission of the NDA for Remoxy in 2010; the cash requirements of the Company for 2009 and expected uses of such cash; expected timing of commencement or completion of clinical trials and non-clinical studies; and the Company's expected receipt and recognition of collaboration revenue, including reimbursement of the Company's ongoing development activities under the collaboration with King. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statemen ts involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing and pursuit of regulatory approval of the Company's drug candidates, 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 additional research and development and other costs and the timing and receipt of funds from the Company's commercial partner, the potential for abuse 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.
PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Six Months
Ended June 30, Ended June 30,
------------------ ------------------
2009 2008 2009 2008
------- ------- ------- --------
Revenue
Collaboration revenue $ 2,649 $ 6,960 $ 5,897 $ 18,012
Program fee revenue 3,587 3,587 7,174 7,174
------- ------- ------- --------
Total revenue 6,236 10,547 13,071 25,186
Operating expenses
Research and development 5,090 11,215 12,726 23,699
General and
administrative 1,414 1,896 3,145 3,716
------- ------- ------- --------
Total operating
expenses 6,504 13,111 15,871 27,415
------- ------- ------- --------
Operating loss (268) (2,564) (2,800) (2,229)
Interest income 233 1,539 620 3,774
------- ------- ------- --------
Income (loss) before
benefit from income tax (35) (1,025) (2,180) 1,545
Benefit from income taxes (1) -- (322) --
------- ------- ------- --------
Net income (loss) $ (34) $(1,025) $(1,858) $ 1,545
======= ======= ======= ========
Net income (loss) per share
Basic $ (0.00) $ (0.02) $ (0.04) $ 0.04
======= ======= ======= ========
Diluted $ (0.00) $ (0.02) $ (0.04) $ 0.04
======= ======= ======= ========
Weighted-average
shares used in
computing net income
(loss) per share
Basic 42,137 41,579 42,114 42,714
======= ======= ======= ========
Diluted 42,137 41,579 42,114 43,974
======= ======= ======= ========
CONDENSED BALANCE SHEETS
June 30, Dec. 31,
2009 2008 (1)
--------- ---------
(Unaudited)
Assets
Current assets
Cash, cash equivalents and marketable
securities $ 182,217 $ 190,095
Other current assets 2,038 541
--------- ---------
Total current assets 184,255 190,636
Non-current assets
Property and equipment, net 641 774
Other assets 1,420 2,026
--------- ---------
Total assets $ 186,316 $ 193,436
========= =========
Liabilities and stockholders' equity
Current liabilities
Accounts payable and accrued development
expense $ 1,466 $ 3,245
Deferred program fee revenue - current
portion 14,348 14,348
Other accrued liabilities 2,255 2,521
--------- ---------
Total current liabilities 18,069 20,114
Non-current liabilities
Deferred program fee revenue - non-current
portion 60,980 68,154
Other liabilities 1,414 882
--------- ---------
Total liabilities 80,463 89,150
--------- ---------
Stockholders' equity
Common stock 42 42
Additional paid-in-capital 221,672 218,021
Accumulated other comprehensive income 99 325
Accumulated deficit (115,960) (114,102)
--------- ---------
Total stockholders' equity 105,853 104,286
--------- ---------
Total liabilities and stockholders' equity $ 186,316 $ 193,436
========= =========
(1) Derived from the Company's annual financial statements as of
December 31, 2008, included in the Company's Annual Report on
Form 10-K filed with the Securities and Exchange Commission.
CONTACT: Pain Therapeutics, Inc.
Judy Ishida, Administrative Manager
650-645-1924
IR@paintrials.com