Q4 2012 Results Earnings Call
February 25, 2013 4:30 p.m. ET
Timothy Morris - CFO
Leland Wilson - CEO
Michael Miller - Chief Commercial Officer and Senior Vice President
Peter Tam - President and Director
Cory Kasimov - JP Morgan
Steve Byrne - Bank of America
Marko Kozul - Leerink Swann
Lee Kalowski - Crédit Suisse
Thomas Wei - Jefferies & Company
Alan Carr - Needham & Company
Simos Simeonidis - Cowen & Company
Jonathan Aschoff - Brean Capital
Jason Butler - JMP Securities
Good day, ladies and gentlemen, and welcome to the VIVUS fourth quarter and year end 2012 results call. [Operator Instructions] I would now like to introduce your host for today’s conference, Mr. Tim Morris. Sir, you may begin.
Thank you, operator. Before we begin, I'd like to remind you that during this conference call, VIVUS will make certain statements that are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995.
These statements may be identified by the use of forward-looking words such as anticipate, believe, estimate, expect, forecast, intend, likely, may, opportunity, potential, plan, predict, and should, among others.
These forward-looking statements are based on VIVUS's current expectations, 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, and investors should read the risk factors set forth in the VIVUS Form 10-K for the year ended December 31, 2011, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.
During the November 12 investor teleconference, and then in January 2013, during the JPMorgan healthcare conference, we provided an update on the actual number of Qsymia prescriptions dispensed for the rolling four-week period ended November 23 and December 21, 2012.
On today’s call, we will provide a similar update for the subsequent rolling four-week period ending January 18 and February 15 2013. In addition, as previously stated, we make no attempt to reconcile this information to data provided by third-party prescription reporting services.
I will now turn the call over to Mr. Leland Wilson, CEO of VIVUS.
Thank you, Tim. Hello and thank you for joining us today. With me on the call, along with Tim, are Peter Tam, our president, and Michael Miller, our chief commercial officer.
The focus of today’s call is to provide an overview of the 2012 highlights and financial results, update you regarding the launch of Qsymia, and share our vision for how Qsymia will become successful in the near future.
2012 represented a landmark year for VIVUS, during which we earned FDA approval of two products, Qsymia, our unique combination of phentermine and extended release topiramate for obesity, and STENDRA our next-generation PDE5 inhibitor for erectile dysfunction. We are proud of the entire team here at VIVUS for these tremendous accomplishments.
You may have seen a report last week in Bloomberg about a recent study published in JAMA. This study found among patients undergoing weight loss surgery, the cost of hospital stays due to complications exceeded the savings from obesity-related illnesses.
The study’s lead author was quoted as saying, “Bariatric surgery isn’t going to be the answer to healthcare costs,” while Kenneth Thorpe, chairman of health policy and management at Emory University’s Rollins School of Public Health, was quoted as saying, “We need more options to address the issues around overweight and obesity that are less interventional and save money.”
Studies with findings of this nature are among the reasons we believe that current trends strongly favor a robust, largely untreated market for oral obesity medications such as Qsymia. It has been 5 months since we launched Qsymia, the first FDA-approved once-daily oral medication that has been shown to achieve an average weight loss of 10% in obese patients.
We continue to see steady growth in Qsymia prescriptions, prescribers, and patients. As we work to build our position with thought leaders, we also continue to make progress with payers and we are working closely with the FDA to gain approval to expand our distribution outlets to include certified retail pharmacies.
Monetizing STENDRA through a regional commercialization of alliances remains high on our priority list as well, and we are pleased that several key development milestones have been reached that will help accelerate this process.
Mike will now speak to the specifics of the Qsymia launch. Peter will provide an update of our REMS modification request with the FDA and the status of the cardiovascular outcome trial study. Tim will then outline the financial results for the year end, and give an update of the STENDRA partnering efforts. Lastly, we’ll take your questions.
Now, I’ll turn the call over to Mike for some specifics on the Qsymia launch.
Thank you, Leland, and good afternoon, everyone. As Leland mentioned, we continue to see positive trends in the prescription growth and gain traction with patients, providers, and payers. The launch has not been without challenges, but we are working hard to address each and every one.
The challenges include the REMS mail order only certified pharmacy network. This has been both an access and prescribing burden issue. We believe that certified retail pharmacy access will significantly help this issue, and once we attain that, providers will be able to simply send their patients to certified retail pharmacies with prescriptions - or they can call them in - in a traditional manner. Patients will be able to fill prescriptions for Qsymia consistent with the manner in which their other prescriptions are filled, without delay or lapses in treatment.
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