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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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)
May 4, 2006
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PAIN THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware 000-29959 91-1911336
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
416 Browning Way
South San Francisco, California 94080
(Address of principal executive offices, including zip code)
(650) 624-8200
(Registrant's telephone number, including area code)
(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))
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ITEM 2.02. RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
On May 4, 2006, Pain Therapeutics, Inc. (the "Company") issued a press release
announcing the Company's financial results for the first quarter March 31, 2006.
A copy of the press release has been furnished as an exhibit to this report and
is incorporated by reference herein.
The information in this Current Report on Form 8-K and in Exhibit 99.1 shall not
be deemed to be "filed" for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by
reference into any registration statement or other document filed or furnished
pursuant to the Exchange Act or the Securities Act of 1933, as amended, except
as shall be expressly set forth by specific reference in such document.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits.
The following exhibit is furnished as part of this Current Report on Form 8-K.
EXHIBIT
NUMBER DESCRIPTION
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99.1 Press Release of Pain Therapeutics, Inc. dated May 4, 2006.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
PAIN THERAPEUTICS, INC.
/s/ Peter S. Roddy
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Peter S. Roddy
Vice President and
Chief Financial Officer
Dated: May 4, 2006
EXHIBIT INDEX
Exhibit
Number Description
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99.1 Press Release of Pain Therapeutics, Inc. dated May 4, 2006.
Exhibit 99.1
FOR MORE INFORMATION CONTACT:
Peter S. Roddy Carney Duntsch (Media)
Vice President & Chief Financial Officer Burns McClellan
Pain Therapeutics, Inc. 212-213-0006
proddy@paintrials.com
650-825-3330
PAIN THERAPEUTICS' FIRST QUARTER 2006 FINANCIAL RESULTS
REFLECT OPERATING AND FINANCIAL STRENGTH
SOUTH SAN FRANCISCO, Calif. - May 4, 2006 - Pain Therapeutics, Inc. (Nasdaq:
PTIE), a biopharmaceutical company, reported first quarter 2006 financial
results today. Net income for the quarter ended March 31, 2006 was $0.9 million,
or $0.02 per share, compared to a net loss of $8.6 million, or $0.20 per share
in the first quarter of 2005.
Cash, cash equivalents and marketable securities were $209.8 million at
March 31, 2006.
"We are pleased to report solid operating and financial performance for the
first quarter of 2006, with an increasing contribution from our alliance with
King Pharmaceuticals, Inc., solid control over our expenses, an on-track
clinical campaign with Remoxy(TM), significant regulatory progress with
Oxytrex(TM) and good prospects of filing at least one additional IND this year
for an undisclosed abuse-resistant drug candidate," said Remi Barbier, president
and chief executive officer.
"We are reconfirming our 2006 financial guidance," said Peter S. Roddy, V.P. &
Chief Financial Officer. "We continue to expect our net cash requirements for
the full year 2006 will be approximately $15 million, plus or minus 10%."
-more-
PIPELINE OF MEDICINES CONTINUES TO ADVANCE
"The first quarter of 2006 marked a strong start of an important year for Pain
Therapeutics' pipeline," said Nadav Friedmann, PhD, MD., Chief Operating &
Clinical Officer.
During the quarter we commenced a pivotal Phase III program with Remoxy, an
abuse-resistant form of twice-daily oxycodone. The Remoxy trial benefits from a
Special Protocol Assessment from the FDA. We believe the clinical program that
was negotiated with the FDA provides a clear path for product approval. About 20
clinical sites across the U.S. are now initiated for the Remoxy study. In March,
we had positive discussions with the FDA regarding a pivotal Phase III program
for Oxytrex, a novel opioid painkiller with minimal physical dependence. We plan
to advance Oxytrex into a pivotal Phase III program by year-end 2006. Then in
April, we announced that we now manufacture a naltrexone dose of 0.0001 mg per
tablet. This represents a 10-fold lower dose of naltrexone. We think this
remarkable technical achievement may hold favorable clinical or regulatory
advantages, such as a more direct comparison of Oxytrex to oxycodone.
FIRST-QUARTER FINANCIAL HIGHLIGHTS
o In December 2005, we entered into a definitive strategic alliance with King
Pharmaceuticals, Inc. ('King') to develop Remoxy and three other
abuse-resistant opioid painkillers. Collaboration revenue of $8.8 million
reflects reimbursement from King of our collaboration expenses incurred
during the first quarter of 2006.
o King gave us an upfront payment of $150 million cash in December 2005. For
accounting purposes, each quarter through mid-2011 we plan to recognize a
portion of this cash payment as 'Program fee revenue'. We recognized
Program fee revenue of $6.6 million this quarter.
o On January 1, 2006 we adopted Statement No. 123(R), Share-Based Payment, or
FAS 123R, as required by the Financial Accounting Standards Board. In
adopting FAS 123R, we began to recognize non-cash equity related expenses
in our financial statements.
o Research and development expenses increased to $12.9 million from $8.1
million in the first quarter of 2005. The increase was primarily related to
Remoxy, including the initiation of a pivotal Phase III study, and
development activities related to other abuse-resistant opioid drug
candidates.
o General and administrative expenses increased to $2.0 million from $1.0
million in the first quarter of 2005. This increase was primarily due to
recognition of non-cash equity related expenses following the adoption of
FAS 123R.
o We have a provision for income taxes of $1.7 million. This amount consists
of the first quarter portion of currently estimated alternative minimum tax
of $2.6 million for the full year 2006. This provision for income taxes
will fluctuate between quarters during 2006.
-more-
CONFERENCE CALL AND WEBCAST INFORMATION
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Pain Therapeutics will host a conference call today at 1:30 p.m. Pacific
Time/4:30 p.m. Eastern Time to discuss this announcement. To participate in the
conference call, please dial 866-578-5801 (within the U.S.) or 617-213-8058
(outside the U.S.) fifteen minutes prior to the start of the call. The call
reference number is 37288731. A playback of the conference call will also be
available. To access the playback, please dial 888-286-8010 (within the U.S.) or
617-801-6888 (outside the U.S.) and enter reservation number 72207618. A webcast
of the conference call will be available online at www.paintrials.com.
ABOUT PAIN THERAPEUTICS, INC.
- -----------------------------
We are a biopharmaceutical company that develops novel drugs. We have two
investigational painkillers, Remoxy and Oxytrex, in Phase III clinical programs.
Both drug candidates target different segments of the multi-billion dollar
market to treat severe chronic pain, such as persistent low-back pain or pain
due to advanced stages of osteoarthritis. We own all commercial rights to
Oxytrex.
OUR ALLIANCE WITH KING PHARMACEUTICALS, INC.
- --------------------------------------------
In December 2005, we closed a strategic alliance with King Pharmaceuticals
for Remoxy and three other abuse-resistant opioid painkillers. King paid us $150
million in cash as an up-front payment. King is also obligated to pay us up to
$150 million in cash based on the successful achievement of certain clinical or
regulatory milestones for Remoxy and three other abuse-resistant opioid
painkillers. King funds all development expenses and is obligated to pay us a
20% royalty on net sales of drugs, except as to the first $1 billion in
cumulative net sales, for which the royalty is set at 15%. In exchange, King
received worldwide commercial rights to Remoxy and three other abuse-resistant
drugs developed under the alliance.
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, scope or expected outcome of the Company's clinical development of
its drug candidates, the potential benefits of the Company's drug candidates,
the Company's expected cash requirements and provision for taxes in 2006, 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.
-Financial Tables Follow-
-more-
PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31,
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2006 2005
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Revenue:
Program fee revenue $ 6,550 $ -
Collaboration revenue 8,776 -
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Total revenue 15,326 -
Operating expenses (1):
Research and development 12,854 8,122
General and administrative 1,970 1,038
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Total operating expenses 14,824 9,160
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Operating income (loss) 502 (9,160)
Other income:
Interest income 2,088 571
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Income (loss) before provision for income taxes 2,590 (8,589)
Provision for income taxes 1,713 -
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Net income (loss) $ 877 $ (8,589)
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Earnings per share
Basic $ 0.02 $ (0.20)
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Diluted $ 0.02 $ (0.20)
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Weighted-average shares used to compute earnings per share
Basic 43,995 43,664
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Diluted 45,505 43,664
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(1) Included in research and development and general and administrative
expenses are non-cash equity related expenses of $957 thousand and $728
thousand, respectively, totaling $1,685 thousand for the three months ended
March 31, 2006. The non-cash equity related expense was immaterial for the
three months ended March 31, 2005.
-more-
PAIN THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
March 31, December 31,
2006 2005(2)
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(Unaudited)
ASSETS
Current assets:
Cash, cash equivalents and marketable securities $ 209,788 $ 212,652
Collaboration revenue receivable 4,234 889
Prepaid expenses 125 623
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Total current assets 214,147 214,164
Property and equipment, net 1,556 1,556
Other assets 75 75
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Total assets $ 215,778 $ 215,795
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 820 $ 998
Accrued development expense 6,318 4,461
Deferred program fee revenue - current portion 26,200 26,200
Accrued compensation and benefits 775 501
Other accrued liabilities 1,847 187
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Total current liabilities 35,960 32,347
Non-current liabilities:
Deferred program fee revenue - non-current portion 113,538 120,088
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Total liabilities 149,498 152,435
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Stockholders' equity:
Common stock 44 44
Additional paid-in-capital 208,868 206,489
Accumulated other comprehensive loss (815) (479)
Accumulated deficit (141,817) (142,694)
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Total stockholders' equity 66,280 63,360
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Total liabilities and stockholders' equity $ 215,778 $ 215,795
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(2) Derived from audited financial statements
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