Pain Therapeutics' First Quarter 2006 Financial Results Reflect Operating and Financial Strength
Thursday May 4, 4:01 pm ET
SOUTH SAN FRANCISCO, Calif., May 4 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE - News), 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%."
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
-- 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.
-- 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.
-- On January 1, 2006 we adopted Statement No. 123®, 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.
-- 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.
-- 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.
-- 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.
Conference Call and Webcast Information
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.
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