VIVUS CEO Discusses Q3 2010 Results - Earnings Call Transcript
VIVUS, Inc. (
)
Q3 2010 Earnings Call
November 8, 2010 4:30 p.m. ET
Executives
Tim Morris – SVP, Finance and CFO
Leland Wilson – CEO
Peter Tam – President and COO
Analysts
Chris James – McNicoll, Lewis & Vlak
Alan Carr – Needham & Co.
Michael Tong – Wells Fargo Securities
Steve Bial [ph] – Bank of America
Thomas Wei – Jefferies & Co.
Adam Cutler - Canaccord
Presentation
Operator
Compare to:
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VIVUS Inc. Q2 2010 Earnings Call Transcript
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VIVUS, Inc. Q1 2010 Earnings Call Transcript
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VIVUS Inc. Q2 2008 Earnings Call Transcript
Good day, ladies and gentlemen, and welcome to the VIVUS third quarter 2010 results conference call. At this time, all participants are on a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. (Operator instructions) As a reminder, this conference call is being recorded.
I would now like to turn the call over to your host, Mr. Tim Morris. Please go ahead, sir.
Tim Morris
Thank you, operator. Before we get started, I’d like to remind you that during this conference call, VIVUS may make certain statements in this call that are considered forward-looking within the meeting of the Private Securities Litigation Reform Act of 1995.
These statements maybe identified by the use of forward-looking words, such as anticipate, believed, planned, estimated, and intend, and among others. These forward-looking statements are based on VIVUS current expectation and actual results could differ materially.
There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substances of VIVUS written response to the FDAs complete response letter, the FDAs interpretation of the information VIVUS submits, relating to the teratogenicity and cardiovascular safety, the FDAs interpretation of the data from our SEQUEL study, or OB-305. Their request, if any, to conduct additional clinical trials, substantial competition, uncertainties of paten production and litigation, alliance on sole-source suppliers, limited sales, and marketing resources, and dependence upon third parties, risk related to the development of innovative products, and risk related to the failure to obtain FDA clearances or approval, and non-compliance with FDA regulation
As with any pharmaceutical in development, there are significant risk in the development and regulatory approval and commercialization of new products. There are no guarantees that our response to the FDA with the CRL will be sufficient to satisfy FDAs safety concern, and that the FDA will not require us to conduct any additional studies, or that any product will receive regulatory approval, or any indication or prove to be commercially successful.
VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS Form 10-K for the year ending December 31, 2009, and periodic reports filed with the Securities and Exchange Commission.
I will now turn the call over to Mr. Leland Wilson, CEO of VIVUS.
Leland Wilson
Thank you, Tim. Good afternoon, and thank you for joining us today. Joining me on the call, along with Tim is VIVUS's President, Peter Tam.
On today's call we will first review the Qnexa CRL received on October 28, 2010, and our planned response. Then we will summarize our results for OB-305, the SEQUEL study we released in late September. We will then provide an update on EU filing for Qnexa, followed by an update on avanafil. We’ll then summarize the MUSE transaction, and finally we’ll provide an update on the cash balance and guidance for the end of the year.
As we previously discussed on October 28, 2010, we received the complete response letter, or CRL from the FDA regarding the Qnexa NDA. The FDA issued the CRL to communicated decision that the NDA cannot be approved in its present form.
We are preparing our response to the FDAs request for information, and are on schedule to submit our response by December 15.
The CRL included request for additional analyses to help the FDA further assess teratogenicity and cardiovascular safety. For teratogenicity, the FDA requested a comprehensive assessment of topiramate and Qnexa to radiogenic potential.
As part of our response, we are compiling analysis integrating existing nonclinical and clinical data, including published research on topiramate. Our response will include a detailed plan to mitigate any potential risk in women of child-bearing potential.
For cardiovascular safety, the FDA asked VIVUS to provide evidence that the elevations in heart rate associated with Qnexa do not increase the risk for major adverse cardiovascular events. In our response, we’ll provide several new analyses which would include data from our SEQUEL and sleep apnea studies. Data from SEQUEL and sleep apnea studies were not included in the original NDA. The CRL also included a request for submission of the final study report from the two-year SEQUEL study.
Peter will review the results from the SEQUEL study momentarily.
Top-line results from this study, were announced by VIVUS on September 21, 2010, and final study report is being prepared as part of our response to the FDA.
The FDA also requested a safety update of any new adverse events since the last safety update.
Finally, the FDA stated that it proved connection with the scheduled fourth drug, due to the phentermine component. FDAs comment on final labeling and REMS are expected after the written requirement is accepted.
We believe we have sufficient data from existing studies with Qnexa to satisfy the FDA’s request. In the CRL, no new clinical studies were requested. However, in the event that FDA concerns are not alleviated by the information of our response, additional clinical studies may be required. We’re working with our regulatory advisors and the FDA to optimize our response strategy. We are on schedule to submit our answers to the questions raised in the CRL by mid-December.
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