Orexigen Therapeutics, Inc. (OREX)

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Orexigen Therapeutics, Inc. (OREX)

Q3 2012 Earnings Call

November 07, 2012, 05:00 pm ET


Heather Turner - SVP, General Counsel & Secretary

Mike Narachi - President & CEO

Mark Booth - Chief Commercial Officer

Preston Klassen - SVP & Head, Global Development

Jay Hagan - Chief Business Officer


Lee Kalowski - Credit Suisse

Steve Byrne - Bank of America



Welcome to the Third Quarter 2012 Orexigen Therapeutics Earnings Conference Call. My name is Loris and I will be your operator for today's call. At this time, all participants are in a listen-only mode and later we will conduct a question-and-answer session. Please note that this conference is being recorded.

I will now turn the call over to Heather Turner, the company’s General Counsel. Heather Tuner, you may begin.

Heather Turner

Hello and thank you for joining us this afternoon. I am joined on this call by Mike Narachi, Chief Executive Officer; Mark Booth, Chief Commercial Officer; Dr. Preston Klassen, Senior Vice President of Development and Jay Hagan, our Chief Business Officer.

Please note that all of the information discussed on this call this afternoon is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that during this call, the company's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings including the Form 10-Q the company plans to file this week.

The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, November 7th, 2012. Orexigen takes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

I will now had the call over to Mike Narachi, Orexigen’s Chief Executive Officer to provide an overview of today’s call. Mike?

Mike Narachi

Thanks Heather and thanks for joining us this afternoon. In addition to an overview of third quarter results and recent events, we’ll have Mark Booth briefly discuss the topline results we recently received from our updated market research. Jay Hagan will then discuss our financial results and the outlook for the remainder of 2012 and then we will open the call up for questions.

The last few months have been an exciting time for Orexigen. We have enrolled the Light Study far more quickly than originally expected which should result in a shorter time to accrual of the 87 MACE events needed to conduct an interim analysis.

We also announced last month that we received support from the FDA to explore a faster path for resubmission of the Contrave New Drug Application. We are working with the agency on the procedural details for this, but the plan would be for the Contrave resubmission to be under review at the time the interim analysis is provided, so that the agency can act upon the application as quickly as possible. If we are able to come to an agreement with the FDA and if the event rate in the Light Study is at or above our annualized target of 1.5%, Contrave could be approved by as early as Q4 next year.

In late October, we completed a follow-on public offering of common stock raising net proceeds of approximately $57 million. This additional capital strengthens our balance sheet as Orexigen moves in to what we hope to be a year of pivotal events.

Next year, in addition to the U.S. resubmission, we plan to submit a marketing authorization application in Europe using the centralized procedure. We met with regulators from three CHMP member states earlier this year and based on these meetings, we believe that the regulatory package we already have for Contrave supplemented with the interim data from the Light Study should be sufficient for review in Europe. We are in discussions with potential partners for rest of the world rights for Contrave and Empatic and we would aim to finalize a transaction sometime after we have the interim data from the Light Study.

I now want to turn the call over the Mark Booth, who will spend a few minutes discussing topline results of the updated market research that we recently conducted and our thoughts about how to grow the obesity therapeutics market. We plan to provide a more detailed overview of this research at an analyst event planned for December 18th in the New York City. Mark?

Mark Booth

Thanks, Mike. The market research we conducted is both extensive and insightful. We surveyed 1,000 physicians including primary care physicians, endocrinologists and OB/GYN’s and we conducted two different studies, both of which exposed the physicians to detailed product profiles of Contrave, Qsymia and Belviq. For the purposes of the research we performed for the discussion today, we assume Contrave will be approved and will be referred new obesity therapeutic to be introduced to the market.

Now the first study was a classic conjoined analysis designed to assess the impact that the Contrave Qsymia and Belviq product profiles will have on preference share. The study also evaluated the impact resourcing will have on the market. For the purposes of the study though we did not evaluate the impact on adoption that could result from the limited distribution channel, one of the colleagues is currently subject to, but we would assume that this would inhibit uptake.

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