Pain Therapeutics Reports Operating Results (10-K)

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Feb 01, 2010
Pain Therapeutics (PTIE, Financial) filed Annual Report for the period ended 2009-12-31.

Pain Therapeutics has a market cap of $223.39 million; its shares were traded at around $5.29 with and P/S ratio of 10.86. PTIE is in the portfolios of Paul Tudor Jones of The Tudor Group.

Highlight of Business Operations:

Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. Our lead drug candidate is called REMOXY. REMOXY is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use. REMOXY and other abuse-resistant painkillers are being developed pursuant to a strategic alliance we have with King. King is obligated to fund development expenses incurred by us for REMOXY and other abuse-resistant painkillers pursuant to the terms of our strategic alliance. We will receive a $15.0 million cash milestone payment from King upon regulatory approval of REMOXY in the United States. We will also receive a royalty equal to 20% of net sales of drugs developed under this strategic alliance, except as to the first $1.0 billion in cumulative net sales, for which the royalty is set at 15%.

We also conduct basic research in collaboration with academic and other partners. Company sponsored research and development expenditures were $47.7 million in 2007, $45.8 million in 2008 and $21.1 million in 2009. We recorded contract revenue related to customer-sponsored research activities under our collaboration with King of $42.7 million in 2007, $29.4 million in 2008 and $6.2 million in 2009.

In 2008, we received $20.0 million in cumulative milestone payments from King for achieving clinical and regulatory milestones, including $15.0 million related to acceptance by the FDA of the NDA for REMOXY, and $5.0 million of acceptance by the FDA of the IND for PTI-721. In 2006, we received $5.0 million for the acceptance by the FDA of the IND for PTI-202. We could also receive from King up to $125.0 million in additional milestone payments in the course of clinical development of REMOXY and other abuse-resistant opioid painkillers under the strategic alliance. In addition, subject to certain limitations, King is obligated to fund development expenses incurred by us pursuant to the collaboration agreement.

We have an exclusive, worldwide Development and License Agreement, or the Durect Agreement, with Durect Corporation, or Durect, to use a patented technology that forms the basis for a number of oral gel-cap drug candidates, including REMOXY. We reimburse Durect for formulation and related work, and make milestone payments based on the achievement of certain technical, clinical or regulatory milestones. Aggregate payments to Durect from the inception of the Durect Agreement in late 2002 to December 31, 2009 were approximately $34.8 million. We paid Durect $1.0 million in upfront payments under the Durect Agreement and $1.7 million for achievement of certain clinical and regulatory milestones. We could pay up to another $7.6 million of potential payments under the Durect Agreement following achievement of certain clinical and regulatory milestones. We have sub-licensed to King certain rights to develop and to commercialize REMOXY and certain other opioid drugs formulated in part with technology we licensed from Durect. King controls preclinical, clinical, commercial manufacturing and sales and marketing activities for REMOXY and we control all of the preclinical, clinical, commercial manufacturing and sales and marketing activities for the other abuse-resistant opioid painkillers. King is obligated to reimburse us for all expenses for formulation and related work and for milestone payments we incur under our agreement with Durect.

We have licensed certain technology, including technology that we use in our monoclonal antibody program for the treatment of metastatic melanoma, from Albert Einstein College of Medicine, or AECOM, pursuant to a License Agreement, or AECOM Agreement. Under the AECOM Agreement, we have a worldwide exclusive license to the technology underlying the AECOM Agreement and all intellectual property rights arising from such technology. The AECOM Agreement requires us to pay AECOM up to $8.0 million in milestone payments, based on certain clinical development and commercial milestones, and royalties of 4% based on sales of licensed products If a product utilizing technology licensed under the AECOM Agreement is combined with a drug or other substance for which we are paying an additional royalty, the royalty that we pay to AECOM will be reduced by up to one-half based on the amount of such additional royalty. In connection with the AECOM Agreement, we also issued a warrant to purchase up to 150,000 shares of our common stock at an exercise price of $6.77 per share, with vesting subject to certain commercial milestones. This warrant expired unvested in January 2010. Aggregate payments to AECOM from the inception of the AECOM Agreement to December 31, 2009 were approximately $1.5 million, inclusive of an up-front payment of $200,000. We have not yet made any milestone payments to AECOM under this agreement.

We have licensed novel gene integration technology from Poetic pursuant to a License Agreement with Poetic, or the Poetic License. We have worldwide commercial rights and all intellectual property rights arising from the technology subject to the Poetic License in all indications in hemophilia and pain management. In connection with the Poetic License, we paid Poetic a $10,000 upfront fee and also issued a warrant to purchase up to 300,000 shares of our common stock at an exercise price of $8.86 per share that does not vest until certain commercialization milestones are met with respect to products relying on technology licensed under the agreement. This warrant is not currently vested and terminates in February 2027. Under the Poetic License, we are also obliged to pay Poetic milestone payments of up to $4.0 million in the aggregate, based on clinical and regulatory progress, and a royalty on net sales in the mid-single digit range. Other than

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