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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) January 27, 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)
Item 7. Financial Statements and Exhibits.
(c) Exhibits.
Exhibit Description
- ------- -----------
99.1 Press Release issued by Pain Therapeutics, Inc., dated January 27, 2004
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 January 27, 2004, Pain Therapeutics, Inc. issued a press release
announcing its results for the year and three month periods ending December 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: January 27, 2004
By: /s/ Peter S. Roddy
-------------------------------
Peter S. Roddy
Chief Financial Officer
EXHIBIT INDEX
Exhibit
Number Description
- ------ -------------------------------------
99.1 Press release, dated January 27, 2004
Exhbiit 99.1
Pain Therapeutics Announces Fourth Quarter and Year End 2003 Financial Results
SOUTH SAN FRANCISCO, Calif., Jan. 27 /PRNewswire-FirstCall/ -- Pain
Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today reported
financial results for the fourth quarter and year ended December 31, 2003.
The net loss for the quarter ended December 31, 2003 was $6.7 million, or
$0.19 per share, compared to a net loss of $5.1 million, or $0.19 per share
for the fourth quarter of 2002. The net loss for the year ended December 31,
2003 was $21.6 million, or $0.73 per share, compared to a net loss of
$15.9 million, or $0.59 per share, for the same period of 2002.
At December 31, 2003 Pain Therapeutics' cash, cash equivalents and
marketable securities were $77.4 million.
"I am pleased with the progress we made in 2003 while keeping our spending
in line with expectations," said Remi Barbier, Pain Therapeutics' president
and chief executive officer. "From every point of view, we believe we are
better off today than we were a year ago. Oxytrex(TM) and PTI-901 are in
Phase III trials. We announced a new drug candidate, Remoxy(TM), which is
expected to be in Phase III by the end of 2004. We believe each of our three
drug candidates has the potential to achieve blockbuster status. We completed
a follow-on public offering. We added two terrific independent board members.
We met over 95 percent of our published milestones on time and on budget. And
we presented data at several technical forums, including the Society for
Neuroscience Meeting and the Scientific Meeting of the American College of
Gastroenterology."
Research and development expenses increased to $6.1 million in the fourth
quarter of 2003 from $3.8 million in the fourth quarter of 2002. Research and
development expenses increased to $18.9 million for the year 2003 from
$11.4 million for the year 2002. Research and development expenses in the
fourth quarter of 2003 included increased spending associated with the
initiation of a Phase I clinical trial with Remoxy in the first quarter of
2004. Research and development expenses in the fourth quarter of 2003 also
included on-going Phase III trial costs for Oxytrex and costs associated with
the initiation of the Phase III program with PTI-901.
General and administrative expenses decreased to $0.9 million in the
fourth quarter of 2003 from $1.6 million in the fourth quarter of 2002.
General and administrative expenses decreased to $3.3 million for the year
2003 from $5.5 million for the year 2002.
Financial Outlook
As previously announced, in 2004 our clinical goals are to conduct Phase
III clinical trials with Oxytrex and PTI-901 and to advance Remoxy from Phase
I into Phase III. These clinical goals will result in estimated cash
requirements in 2004 of $37 million, plus or minus 10 percent. We expect our
cash spending to decrease after the completion of Phase III trials.
The net loss for 2004 is expected to be approximately $39 million, plus or
minus 10 percent. The net loss for 2004 is expected to be higher than the
cash spending primarily due to non-cash expenses included in the net loss.
Cash spending and expenses will continue to fluctuate on a
quarter-to-quarter basis and continue to depend on the timing of clinical
trials and expenses related to all three clinical programs.
About Pain Therapeutics, Inc.
We are a biopharmaceutical company specializing in the development of
novel painkillers. We believe our unique insights into the biology and
biochemistry of pain allow us to develop new drug candidates that address
unmet clinical needs in pain management. We have two drug candidates in Phase
III clinical trials: Oxytrex for chronic pain and PTI-901 for patients with
Irritable Bowel Syndrome. Our third drug candidate, Remoxy, is an abuse
resistant, long-acting oxycodone. 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
blockbuster potential 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 S-3 as amended, filed
September 22, 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 Year ended
December 31, December 31,
2003 2002 2003 2002
Operating expenses (1):
Research and development $6,052 $3,776 $18,913 $11,396
General and administrative 882 1,552 3,338 5,523
Total operating expenses 6,934 5,328 22,251 16,919
Operating loss (6,934) (5,328) (22,251) (16,919)
Other income:
Interest income 250 193 634 994
Net loss ($6,684) ($5,135) ($21,617) ($15,925)
Basic and diluted loss per share ($0.19) ($0.19) ($0.73) ($0.59)
Weighted-average shares used in
computing basic and diluted loss
per share 35,362 27,139 29,483 27,039
(1) Included in operating expenses are stock based compensation expenses
of $79 and $68 for the quarters ended December 31, 2003 and 2002, and
$139 and $210 for the years ended December 31, 2003 and 2002,
respectively.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
BALANCE SHEETS
(in thousands)
December 31,
2003 2002 (2)
Assets
Current assets:
Cash and cash equivalents $12,027 $50,091
Marketable securities 65,402 55
Prepaid expenses 1,321 1,101
Total current assets 78,750 51,247
Property and equipment, net 1,688 2,003
Other assets 75 75
Total assets $80,513 $53,325
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $3,441 $2,648
Accrued compensation and benefits 369 273
Other accrued liabilities 141 180
Total liabilities 3,951 3,101
Stockholders' equity
Common stock 35 27
Additional paid-in-capital 150,732 103,254
Deferred compensation (7) (304)
Notes receivable from stockholders -- (122)
Accumulated other comprehensive
income 50 --
Deficit accumulated during the
development stage (74,248) (52,631)
Total stockholders' equity 76,562 50,224
Total liabilities and
stockholders' equity $80,513 $53,325
(2) Derived from audited financial statements.
SOURCE Pain Therapeutics, Inc.
-0- 01/27/2004
/CONTACT: Christi Waarich, Senior Manager of Investor Relations of Pain
Therapeutics, Inc., +1-650-825-3324, or cwaarich@paintrials.com/
/Web site: http://www.paintrials.com /
(PTIE)
CO: Pain Therapeutics, Inc.
ST: California
IN: HEA BIO MTC
SU: ERN ERP