Arena Pharmaceuticals, Inc. (ARNA)
Q3 2012 Results Earnings Call
November 6, 2012 5:00 PM ET
Cindy McGee - Vice President, IR and Alliance Management
Jack Lief - President and CEO
Craig Audet - Senior Vice President, Operations and Head, Global Regulatory Affairs
Robert Hoffman - Chief Financial Officer
Dominic Behan - Chief Scientific Officer
Matt Lowe - JPMorgan
Lee Kalowski - Credit Suisse
Ted Tenthoff - Piper Jaffray
Thomas Wei - Jefferies
Steve Byrne - Bank of America
Alan Carr - Needham & Company
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Welcome and thank you for joining us. On today’s call we will review our third quarter financial results and provide a corporate update. Our update will include details of our collaboration with Ildong for South Korea that we just announced today.
Prepared remarks will be provided by Jack Lief, our President and Chief Executive Officer; Craig Audet, our Senior Vice President of Operations and Head of Global Regulatory Affairs; and Robert Hoffman, our Chief Financial Officer. Dominic Behan, our Chief Scientific Officer, will also be available to address your questions.
During this conference call, we will make forward-looking and other statements about our vision, views, goals, plans, expectations and future activities and events, including statements about BELVIQ and our drug candidate, including with regard to efficacy, safety, potential and future research and development, current and future collaborations, the regulatory process, commercialization and other statements that are not historical facts. Such statements may include the words plan, will, expect, believe, may, could, would or similar words.
You are cautioned to not place undue reliance on these forward-looking statements, which are only predictions and reflect the company’s beliefs, expectations and assumptions based on currently available information and speak only as of the time they are made. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995.
Risks and uncertainties that could cause actual results to differ materially from those described in our forward-looking statements include, drug development, the regulatory process and commercialization are uncertain, data and other information related to drug and drug candidates may not be as expected, favorable or sufficient for further development or commercialization, the results of our current collaboration and ability to enter into additional collaboration, the timing, outcome, uncertainly and cost of research and development, the regulatory process, manufacturing and commercialization, and other risks identified in our SEC reports. For a discussion of these and other factors, please refer to the Risk Factors in our SEC filings.
I will now turn the call over to Jack.
Thanks, Cindy. This is a busy and exciting time at Arena as we prepare for the launch of BELVIQ in the United States, pursue regulatory approval in marketing, collaborations for BELVIQ in additional territories and advance our earlier stage drug candidates.
The most significant event in our history is about to occur, the availability of our first internally discovered drug BELVIQ. So, first, I’d like to review our long-term vision for Arena.
I believe BELVIQ as a single agent will be an important treatment option that benefits physicians and patients in their efforts for successful chronic weight management. BELVIQ will be effectively commercialized around the world through strategic marketing and supply collaborations.
Our research and development will establish BELVIQ as a safe and effective treatment in combination with agents such as phentermine and metformin. BELVIQ will also be developed as a treatment for additional indications such as smoking cessation and independently or in collaboration, we will successfully develop our pipeline to deliver best-in-class treatments for a number of diseases.
Most importantly, we plan to realize our vision in a profitable manner that returns value to our stockholders. This means striking the right balance between pursuing development opportunities and managing expenses in light of BELVIQ revenue and shared costs with our collaborators. We thank you for your support, as we move forward on this exciting path.
On today’s call, Craig will provide updates on BELVIQ launch activities and our regulatory efforts and Robert will review our financials. I will then outline our plans to realize the global potential of BELVIQ, including through strategic collaborations with Ildong of South Korea.
Lastly, before opening the call to your questions, I will discuss the advancement of our pipeline and review our upcoming milestones.
I will now turn the call over to Craig.
As Jack mentioned, we’re working with Eisai to prepare for the U.S. launch of BELVIQ, following the completion of DEA scheduling. We are waiting the DEA’s publication of its recommended scheduling designation in the Federal register, which will mark the beginning of the 30-day public comment period. After this period, the DEA will address any comment it receives and publish its final scheduling decision.
In order to enable the availability of BELVIQ for patients as quickly as possible, following completion of the scheduling process, I’m pleased to report that we have recently delivered a portion of the U.S. launch supply to Eisai.
Our colleagues at Eisai believe BELVIQ will be one of the most important compounds in the history of their organization, based on the drug’s strong marketing position. Eisai is focused on delivering increasing sales of BELVIQ each year by expanding its sales force, following the initial market penetration and improved reimbursement.