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SEC Filings

S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 04/09/2007
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Table of Contents

risks that you should be aware of before you decide to buy our common stock. In particular, you should consider the following risks, which are discussed more fully in “Risk Factors” beginning on page 9:
 
  •      We are largely dependent on the success of our only two product candidates, Contrave and Empatic, and we cannot be certain that our planned clinical development programs will be sufficient to support NDA submissions or that either product candidate will receive regulatory approval or be successfully commercialized.
 
  •      Delays in the commencement, enrollment or completion of clinical testing for either of our product candidates could result in increased costs to us and delay or limit our ability to obtain regulatory approval.
 
  •      Contrave and Empatic may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or commercialization.
 
  •      We rely on third parties to conduct our clinical trials and manufacture our product candidates, and we cannot be sure that they will successfully carry out their contractual duties or meet expected deadlines.
 
  •      Our product candidates have not been, and may not be, approved for sale by regulatory authorities.
 
  •      Even if our product candidates are approved by regulatory authorities, we expect intense competition in the obesity marketplace.
 
  •      Although we have exclusive licenses to composition of matter patents covering the combinations of drug products in Contrave and Empatic, physicians may nevertheless seek to prescribe the individual components of our product candidates in different, generically-available forms, and pharmacies and benefit managers may seek to substitute generic products, in either case diminishing our market opportunity.
 
  •      We have had a history of losses since our inception and we expect that losses will continue and increase in future periods. Our net losses were $1.9 million in 2003, $7.7 million in 2004, $12.1 million in 2005 and $27.5 million in 2006. As of December 31, 2006, we had an accumulated deficit of $49.2 million.
 
Corporate Information
 
We were incorporated in Delaware in September 2002. Our principal executive offices are located at 12481 High Bluff Drive, Suite 160, San Diego, California 92130, and our telephone number is (858) 436-8600. Our website address is http://www.orexigen.com. The information on or accessible through our website is not part of this prospectus.
 
We have received a Notice of Allowance from the U.S. Patent and Trademark Office, or PTO, for the intent-to-use trademark application for our corporate logo for use in connection with pharmaceutical preparations and substances, including for the treatment of obesity, inducement of weight loss and prevention of weight gain. We have foreign trademark applications pending in Europe, Canada and Japan for the same mark. We have obtained foreign trademark registrations for the corporate name Orexigen Therapeutics, Inc. and the mark OREXIGEN in Japan and have pending trademark applications for the same mark in the United States, Canada and Europe. We have received a Notice of Allowance from the PTO for the intent-to-use trademark applications for the marks CONTRAVE and EMPATIC for use in connection with pharmaceutical preparations, including for the treatment of obesity and inducing weight loss. We have also obtained foreign trademark registration for the mark CONTRAVE in Japan and have applied for trademark registrations for the mark CONTRAVE in Europe and Canada and the mark EMPATIC in Europe, Canada and Japan. This prospectus also includes trademarks of other persons, including Acomplia®, Alli®, Depade®, Meridia®, Revia®, Trexan®, Vivitrol®, Wellbutrin®, Xenical®, Zimulti®, Zonegran® and Zyban®.


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