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) October 19, 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)
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:
|_| 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 240.13a-4(c))
TABLE OF CONTENTS
-----------------
Item 9.01 Financial Statements and Exhibits.
Item 2.02 Results of Operations and Financial Condition
SIGNATURE
EXHIBIT INDEX
EX - 99.1 Press release
Item 9.01 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 October 19, 2004
Item 2.02 Results of Operations and Financial Condition
On October 19, 2004, Pain Therapeutics, Inc. issued a press release
announcing its results for the quarterly period ending September 30, 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: October 19, 2004 By: /s/ Peter S. Roddy
-----------------------
Peter S. Roddy
Chief Financial Officer
EXHIBIT INDEX
Exhibit
Number Description
------ -------------------------------------
99.1 Press Release, dated October 19, 2004
Exhibit 99.1
Pain Therapeutics Announces Third Quarter 2004 Financial Results
SOUTH SAN FRANCISCO, Calif., Oct. 19 /PRNewswire-FirstCall/ --
Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today
reported financial results for the three and nine months ended September 30,
2004.
The net loss for the quarter ended September 30, 2004 was $9.2 million, or
$0.26 per share, compared to a net loss of $6.0 million, or $0.21 per share in
the third quarter of 2003. The net loss for the nine months ended September
30, 2004 was $28.5 million, or $0.80 per share, compared to a net loss of
$14.9 million, or $0.54 per share for nine months ended September 30, 2003.
Cash, cash equivalents and marketable securities totaled $53.6 million at
September 30, 2004. This amount excludes proceeds from a recently completed
$58 million public offering.
"Our financial results tie into the successful completion of clinical and
corporate milestones," said Remi Barbier, president and chief executive
officer. "Even though we now have more money in the bank as a result of our
recent public offering, we intend to maintain fiscal discipline throughout the
organization. We see no change in financial guidance for 2004. We continue
to believe our cash requirements for 2004 will be approximately $37 million,
plus or minus 10 percent."
Research and development expenses for the third quarter of 2004 increased
to $8.5 million from $5.4 million for the same three-month period in 2003.
Research and development expenses for the nine months ended September 30, 2004
increased to $26.2 million from $12.9 million for the same nine-month period
in 2003. The increase in research and development expenses was primarily due
to costs related to the Phase III clinical programs with Oxytrex(TM) and
PTI-901 as well as the continued development of Remoxy(TM).
General and administrative expenses for the second quarter of 2004
increased to $0.9 million from $0.7 million for the same period in 2003.
General and administrative expenses for the nine months ended September 30,
2004 increased to $2.9 million from $2.5 million for the same period in 2003.
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.
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 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
prospectus supplement dated October 6, 2004.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2004 2003 2004 2003
Operating expenses (1):
Research and development $8,547 $5,358 $26,224 $12,861
General and
administrative 861 735 2,904 2,456
Total operating
expenses 9,408 6,093 29,128 15,317
Operating loss (9,408) (6,093) (29,128) (15,317)
Other income:
Interest income 177 124 668 385
Net loss $(9,231) $(5,969) $(28,460) $(14,932)
Basic and diluted loss
per common share $(0.26) $(0.21) $(0.80) $(0.54)
Weighted-average shares
used in computing basic
and diluted loss per
common share 35,594 27,999 35,507 27,502
(1) Included in research and development and general and administrative
expenses are stock based compensation expenses of $20 thousand
and ($27) thousand for the three-month periods ended September 30,
2004 and 2003, respectively, and $332 thousand and $60 thousand
for the nine-month periods ending September 30, 2004 and 2003,
respectively.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
BALANCE SHEETS
(in thousands)
September 30, December 31,
2004 2003(2)
(Unaudited)
Assets
Current assets:
Cash, cash equivalents and
marketable securities $53,559 $77,429
Prepaid expenses 415 1,321
Total current assets 53,974 78,750
Property and equipment, net 1,753 1,688
Other assets 75 75
Total assets $55,802 $80,513
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $831 $2,231
Accrued development expense 5,780 1,210
Accrued compensation and benefits 375 369
Other accrued liabilities 141 141
Total liabilities 7,127 3,951
Stockholders' equity:
Common stock 36 35
Additional paid-in-capital 151,469 150,732
Deferred compensation -- (7)
Accumulated other comprehensive
income (loss) (122) 50
Deficit accumulated during the
development stage (102,708) (74,248)
Total stockholders' equity 48,675 76,562
Total liabilities and stockholders'
equity $55,802 $80,513
(2) Derived from audited financial statements.
SOURCE Pain Therapeutics, Inc.
-0- 10/19/2004
/CONTACT: Christi Waarich, Senior Manager of Investor Relations of Pain
Therapeutics, Inc., +1-650-825-3324, or cwaarich@paintrials.com; or media,
Kathy Nugent, Ph.D. of Burns McClellan, +1-212-213-0006, for Pain
Therapeutics, Inc./
/Web site: http://www.paintrials.com /
(PTIE)
CO: Pain Therapeutics, Inc.
ST: California
IN: BIO HEA MTC
SU: ERN