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 22, 2004
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 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 22, 2004
Item 12. Results of Operations and Financial Condition
On April 22, 2004, Pain Therapeutics, Inc. issued a press release
announcing its results for the quarterly period ending March 31, 2004. A copy of
this press release is attached hereto as Exhibit 99.1.
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, as amended, 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.
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 22, 2004 By: /s/ Peter S. Roddy
------------------
Peter S. Roddy
Chief Financial Officer
EXHIBIT INDEX
Exhibit
Number Description
- ------- --------------------------------------------------------------------
99.1 Press Release, Dated April 22, 2004
Exhibit 99.1
Pain Therapeutics Announces First Quarter 2004 Financial Results
SOUTH SAN FRANCISCO, Calif., April 22 /PRNewswire-FirstCall/ -- Pain
Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today reported
financial results for the three months ended March 31, 2004.
The net loss for the quarter ended March 31, 2004 was $10.2 million, or
$0.29 per share, compared to a net loss of $4.6 million, or $0.17 per share in
the first quarter of 2003.
Cash, cash equivalents and marketable securities were $70.2 million at
March 31, 2004. The Company continues to expect its cash requirements for 2004
to be approximately $37 million, plus or minus ten percent.
"We are pleased with our clinical and financial results for the first
quarter of 2004," said Remi Barbier, president and chief executive officer.
"We met 100 percent of our written milestones on-time, on-budget."
Research and development expenses for the first quarter of 2004 increased
to $9.5 million from $3.8 million in the first quarter of 2003 primarily due
to clinical trial related expenses for Oxytrex(TM), PTI-901 and Remoxy(TM),
including the costs associated with the recent initiation of a second Phase
III study with Oxytrex.
General and administrative expenses decreased to $0.9 million in the first
quarter of 2004 from $1.0 million in the first quarter of 2003 primarily due
to lower non-cash equity related expenses.
No Changes to Financial Outlook
Cash, cash equivalents and marketable securities were $70.2 million at
March 31, 2004. We continue to expect our cash requirements for 2004 to be
approximately $37 million, plus or minus ten percent. We continue to expect
our net loss for 2004 to be approximately $39 million, plus or minus
10 percent. The net loss for 2004 is expected to be higher than the cash
requirements primarily due to non-cash expenses included in the net loss.
Our cash spending and expenses will continue to fluctuate on a
quarter-to-quarter basis depending on the timing of our clinical studies and
related expenses.
Expected Announcements Q2 2004
-- Remoxy Study Results: Phase I/pharmacokinetics and Anti-abuse Data in
Humans
-- Technical Presentation at American Pain Society Meeting
(May 6-9, Vancouver, Canada)
-- Clinical Progress Conference Call (Oxytrex, Remoxy, PTI-901)
About Pain Therapeutics, Inc.
We are a biopharmaceutical company that develops novel drugs. Our drugs
target severe chronic pain, such as pain associated with osteoarthritis,
low-back pain or irritable bowel syndrome. We have three unique drug
candidates in clinical development: Oxytrex, Remoxy and PTI-901. Our two most
advanced drugs, Oxytrex and PTI-901, are in Phase III clinical trials. Remoxy
is in Phase I clinical trials in the United Kingdom. We believe the target
market for our three drug candidates exceeds $3 billion per year. We currently
retain commercial rights to our drug candidates.
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 (the "Act"). PTI 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, the Company's expected cash requirements in 2004 and through
late-stage development of its drug candidates, the Company's net loss for
2004, the potential benefits of the Company's drug candidates and the size of
the potential market for the Company's products. 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,
2003 and its subsequent periodic filings.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended March 31,
2004 2003
Operating expenses (1):
Research and development $9,496 $3,788
General and administrative 937 970
Total operating expenses 10,433 4,758
Operating loss (10,433) (4,758)
Other income:
Interest income 270 141
Net loss $(10,163) $(4,617)
Basic and diluted loss per share $(0.29) $(0.17)
Weighted-average shares used in computing
basic and diluted loss per share 35,426 27,157
(1) Included in research and development and general and administrative
expenses are stock-based compensation expenses of $52 and $103 for the
quarters ended March 31, 2004 and 2003, respectively.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
BALANCE SHEETS
(Unaudited)
(in thousands)
March 31, December 31,
2004 2003(2)
Assets
Current assets:
Cash, cash equivalents and
marketable securities $70,185 $77,429
Prepaid expenses 355 1,321
Total current assets 70,540 78,750
Property and equipment, net 1,810 1,688
Other assets 75 75
Total assets $72,425 $80,513
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $5,105 $3,441
Accrued compensation and benefits 580 369
Other accrued liabilities 135 141
Total liabilities 5,820 3,951
Stockholders' equity
Common stock 35 35
Additional paid-in-capital 150,824 150,725
Accumulated other comprehensive income 157 50
Deficit accumulated during the
development stage (84,411) (74,248)
Total stockholders' equity 66,605 76,562
Total liabilities and stockholders' equity $72,425 $80,513
(2) Derived from audited financial statements.
SOURCE Pain Therapeutics, Inc.
-0- 04/22/2004
/CONTACT: Christi Waarich, Senior Manager of Investor Relations of Pain
Therapeutics, Inc., +1-650-825-3324; or media, Kathy Jones, Ph.D. of Burns
McClellan, +1-212-213-0006, or cwaarich@paintrials.com, for Pain Therapeutics,
Inc./
/Web site: http://www.paintrials.com /
(PTIE)
CO: Pain Therapeutics, Inc.
ST: California
IN: BIO MTC HEA
SU: ERN ERP CCA