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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) April 24, 2003
Pain Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware 000-29959 91-1911336
(State or other jurisdiction (Commission File Number) (I.R.S. Employer
of incorporation) Identification Number)
416 Browning Way, South San Francisco 94080
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (650) 624-8200
N/A
(Former name or former address, if changed since last report)
TABLE OF CONTENTS
Item 7. Financial Statements and Exhibits.
Item 9. Regulation FD Disclosure (pursuant to "Item 12. Results of Operations
and Financial Condition")
SIGNATURE
EXHIBIT INDEX
EX - 99.1 Press release
Item 7. Financial Statements and Exhibits.
(c) Exhibits
The following exhibits are filed with this report on Form 8-K:
Exhibit
Number Description
------ -----------
99.1 Press Release, dated April 24, 2003
Item 9. Regulation FD Disclosure (pursuant to "Item 12. Results of Operations
and Financial Condition")
In accordance with SEC Release No. 33-8216, the following information,
intended to be furnished under "Item 12. Results of Operations and Financial
Condition," is instead furnished under "Item 9. Regulation FD Disclosure." The
information in this Form 8-K and the Exhibit attached hereto shall not be deemed
"filed" for purposes of Section 18 of the Securities Exchange Act of 1934, nor
shall it be deemed incorporated by reference in any filing under the Securities
Act of 1933, except as shall be expressly set forth by specific reference in
such filing.
On April 24, 2003, Pain Therapeutics, Inc. issued a press release
announcing its results for the quarterly period ending March 31, 2003. A copy of
this press release is attached hereto as Exhibit 99.1.
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 thereunto duly authorized.
PAIN THERAPEUTICS, INC.
a Delaware corporation
Date: April 28, 2003
By: /s/ Peter S. Roddy
-----------------------
Peter S. Roddy
Chief Financial Officer
EXHIBIT INDEX
Exhibit
Number Description
- ------ -----------
99.1 Press Release, Dated April 24, 2003
Exhibit 99.1
For More Information Contact:
Christi Waarich
Manager of Investor Relations
Pain Therapeutics, Inc.
cwaarich@paintrials.com
650-825-3324
FOR IMMEDIATE RELEASE
PAIN THERAPEUTICS ANNOUNCES
FIRST QUARTER 2003 FINANCIAL RESULTS
SOUTH SAN FRANCISCO, Calif. - April 24, 2003 - Pain Therapeutics, Inc. (Nasdaq:
PTIE), a medical research company, today reported financial results for the
three months ended March 31, 2003.
The net loss for the quarter ended March 31, 2003 was $4.6 million, or $0.17 per
share, compared to a net loss of $4.0 million, or $0.15 per share in the first
quarter of 2002.
Cash and cash equivalents totaled $45.7 million at March 31, 2003. The Company
continues to expect its cash requirements for 2003 to be approximately $20
million.
"We are pleased to have met our clinical and financial goals in the first
quarter of 2003," said Remi Barbier, Pain Therapeutics' president and chief
executive officer. "We remain focused on developing Oxytrex(TM) and look forward
to announcing the initiation of a Phase III pivotal trial in June of this year,
pending safety results of a 21-day study."
Research and development expenses for the first quarter of 2003 increased to
$3.8 million from $2.8 million in the first quarter of 2002 primarily due to
costs related to the continued enrollment in a 21-day safety study with
Oxytrex(TM).
General and administrative expenses decreased to $1.0 million in the first
quarter of 2003 from $1.5 million in the first quarter of 2002 primarily due to
lower non-cash equity related expenses as well as lower common occupancy
expenses.
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Financial Outlook
Cash requirements are expected to continue to be slightly higher in the second
half of 2003 compared to the first half of 2003. Our cash requirements and
expenses will continue to fluctuate on a quarter-to-quarter basis and will
depend on the timing of our clinical trials and development expenses for
Oxytrex(TM) as well as the development of our other product candidates.
Upcoming Announcements
o May - Corporate presentation at the CIBC World Markets Biotechnology
Conference
o June - Corporate presentation at the Needham & Company Biotechnology
Conference
o June - Announce results of our 21-day safety trial with OxytrexTM
o June - Announce initiation of a Phase III clinical study with
OxytrexTM
o June - Announce results of a pilot study in 50 patients treated with
PTI-901, our proprietary drug for patients with irritable bowel
syndrome
About Opioid Painkillers
Opioid ('narcotic') painkillers are drugs derived from opium and the poppy
plant. The clinical use of opioid drugs to treat severe pain is widely accepted
throughout the world. In the United States, opioid drugs exceed $3 billion in
annual sales and account for over five percent of all prescription drug sales.
Despite widespread use, opioid painkillers have debilitating effects that limit
their usefulness at all doses. Chronic use may lead to tolerance, dependence,
abuse, or, more rarely, addiction. As a result, some patients prefer to suffer
through pain rather than endure the ill effects of opioid drugs. The
under-treatment of pain is a serious and growing problem in the U.S. For
example, according to the National Institutes of Health, over 40 million
Americans are unable to find relief from their pain.
About Pain Therapeutics, Inc.
We are a medical research company specializing in the discovery and development
of novel proprietary painkillers. We believe our lead drug candidate, OxytrexTM,
may offer more pain relief (with no increase in side-effects) or lower
tolerance/dependence, withdrawal effects or addiction potential compared to
conventional forms of oxycodone. The market for oxycodone exceeded $1.5 billion
in the United States in 2002. Pain Therapeutics is traded on NASDAQ under the
symbol PTIE. For more information, please visit our website at
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 and it is Pain Therapeutics' intent that such statements be
protected by the safe harbor created thereby. Examples of such statements
include, but are not limited to, any statements relating to the timing or
anticipated results of the Company's clinical development of its drug
candidates, the potential benefits of the Company's drug candidates, the size of
the potential market for the Company's products, upcoming announcements by the
Company, and net cash requirements and other expenses. 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, unexpected adverse side effects
or inadequate therapeutic efficacy of the Company's drug candidates that could
slow or prevent product approval or market acceptance (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, the Company's ability to
obtain additional financing if necessary and unanticipated research and
development and other costs. 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, including its Form 10-K for
the year ended December 31, 2002 and its subsequent quarterly filings. The
BUTTERFLY DESIGN/LOGO is a registered trademark of Pain Therapeutics, Inc.
-Financial Tables Follow-
-more-
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATION
(in thousands except per share data)
(Unaudited)
Three months ended
March 31,
------------------------
2003 2002
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Operating expenses: (1)
Research and development $ 3,788 $ 2,815
General and administrative 970 1,506
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Total operating expenses 4,758 4,321
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Operating loss (4,758) (4,321)
Other income:
Interest income 141 295
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Net loss $ (4,617) $ (4,026)
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Basic and diluted loss per share $ (0.17) $ (0.15)
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Weighted-average shares used in computing
basic and diluted loss per share 27,157 26,909
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(1) Included in research and development and general and administrative
expenses are stock based compensation expenses of $103 and $342 for the
three months ended March 31, 2003 and 2002.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
BALANCE SHEETS
(Unaudited) (in
thousands)
March 31, December 31,
2003 2002
----------- ------------
Assets
Current assets:
Cash and cash equivalents $ 45,664 $ 50,091
Interest receivable 46 55
Prepaid expenses 326 1,101
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Total current assets 46,036 51,247
Property and equipment, net 1,917 2,003
Other assets 75 75
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Total assets $ 48,028 $ 53,325
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Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 1,728 $ 2,648
Accrue compensation and benefits 389 273
Accrued liabilities 202 180
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Total current liabilities 2,319 3,101
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Stockholders' equity
Common stock 27 27
Additional paid-in-capital 103,248 103,254
Deferred compensation (195) (304)
Notes receivable from stockholders (123) (122)
Deficit accumulated during the development stage (57,248) (52,631)
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Total stockholders' equity 45,709 50,224
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Total liabilities and stockholders' equity $ 48,028 $ 53,325
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