Gilead Sciences' CEO Discusses Q4 2011 Results - Earnings Call Transcript

Gilead Sciences (GILD)

Q4 2011 Earnings Call

February 02, 2012 5:00 pm ET

Executives

Susan Hubbard - Vice President of Investor Relations

John F. Milligan - President and Chief Operating Officer

Robin L. Washington - Chief Financial Officer, Principal Accounting Officer and Senior Vice President

Kevin B. Young - Executive Vice President of Commercial Operations

Norbert W. Bischofberger - Chief Scientific Officer and Executive Vice President of Research & Development

John C. Martin - Chairman of the Board and Chief Executive Officer

Analysts

Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division

Mark J. Schoenebaum - ISI Group Inc., Research Division

Rachel L. McMinn - BofA Merrill Lynch, Research Division

Matthew Roden - UBS Investment Bank, Research Division

Yaron Werber - Citigroup Inc, Research Division

Sapna Srivastava - Goldman Sachs Group Inc., Research Division

Brian Abrahams - Wells Fargo Securities, LLC, Research Division

Robyn Karnauskas - Deutsche Bank AG, Research Division

M. Ian Somaiya - Piper Jaffray Companies, Research Division

Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division

Thomas Wei - Jefferies & Company, Inc., Research Division

Thomas J. Russo - Robert W. Baird & Co. Incorporated, Research Division

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Ravi Mehrotra - Crédit Suisse AG, Research Division

Philip Nadeau - Cowen and Company, LLC, Research Division

Brian Skorney - Brean Murray, Carret & Co., LLC, Research Division

Jim Birchenough - BMO Capital Markets U.S.

Presentation

Operator

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Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Fourth Quarter 2011 Earnings Conference Call. My name is Stacy, and I will be your conference moderator for today. [Operator Instructions] As a reminder, this conference call is being recorded today, February 2, 2012. I would now like to turn the call over to Ms. Susan Hubbard, Vice President of Investor Relations. Please go ahead.

Susan Hubbard

Thank you, Stacy. Good afternoon, everyone, and welcome to Gilead's Fourth Quarter 2011 Earnings Conference Call. We issued a press release this afternoon providing earnings results for the quarter and full year 2011. Its press release is available on our website as are the slides that provide much more detail around the topics covered on today's call. I'm joined today by our President and Chief Operating Officer, John Milligan, who will review the key milestones and strategic initiatives from 2011; followed by our CFO, Robin Washington, who will provide additional details on our financial results and our 2012 guidance; Kevin Young, EVP of Commercial Operations will discuss our commercial performance; and then Norbert Bischofberger, EVP of R&D, will provide an R&D update and key milestones. John Martin, Chairman and CEO, will close out the prepared remarks by outlining our strategic initiatives for the year ahead.

As a reminder, during today's call, we will be making forward-looking statements regarding our financial outlook in addition to regulatory and product development plan. These statements are subject to risks and uncertainties that may cause actual results to differ from those expressed in any forward-looking statement.

A description of these risks can be found on our latest SEC disclosure documents and recent press releases. In addition, please note we undertake no duty to update or revise them. We will also use non-GAAP financial measures to help you understand our underlying business performance. The GAAP reconciliations are provided in our press release as well as on our corporate website.

I will now turn the call over to John Milligan.

John F. Milligan

Thank you, Susan. Thank you all for joining us today. Our team's hard work over the last several years resulted in many significant financial, commercial and R&D milestones in 2011. We saw record revenues for ATRIPLA, Truvada, AmBisome, Ranexa, Letairis and Cayston. We also achieved record market share for our combined HIV portfolio as well as our cardiopulmonary products. Robin and Kevin will review these outstanding financial and commercial results with you and then Norbert will describe some of our many R&D accomplishments.

Single-tablet regimens are becoming the standard of care for HIV treatment, and as you know, it is Gilead's ongoing strategy to provide HIV patients with additional options for simplified regimens. During the fourth quarter, the European Commission granted approval of the Truvada rilpivirine, single-tablet regimen for the treatment of HIV. This product, marketed in the EU as Eviplera and as Complera in the U.S., constitutes our second single-tablet regimen and began launching in 2011 in the U.S., Canada, the U.K. and Austria.

Regulatory submissions for approval were made in the U.S. and EU during 2011 for Quad, which if approved will be Gilead's third single-tablet regimen for the treatment of HIV infection. The NDA was filed less than 6 weeks after data lock. These accelerated timelines for collecting and analyzing the data and filing in both the U.S. and EU were made possible by the dedication and skill of our R&D teams.

Just 2 weeks ago, FDA approved lower strength tablets and an oral powder formulation of Viread for the treatment of HIV-1 infection in pediatric patients from ages 2 to 12. We are pleased to provide this important therapeutic option for younger HIV patients and are working to make the pediatric formulations of Viread available in the U.S. and abroad.

For a number of years, we've been collaborating with various organizations to explore the use of Truvada for pre-exposure prophylaxis or PrEP. Several studies have shown that the use of Truvada in uninfected at-risk adults can reduce HIV transmission. Based on these observations, a supplemental NDA was submitted to FDA in December for the approval of Truvada for prevention of HIV infection among uninfected high-risk adults. To get expert advice on this application, FDA is determined that an advisory committee meeting for the antiviral division will be held in the May timeframe.

We continue to believe that there's room for significant innovation in the area of HIV and during the year announced a new collaboration with Tibotec to develop the first single-tablet regimen containing a protease inhibitor. Tibotec's PI, darunavir, has now been successfully combined into a single pill with emtricitabine and our investigational agents, cobicistat and GS-7340. And we anticipate clinical studies to begin later this year. In addition, a Phase II study was initiated in the fourth quarter of 2011 for a single-tablet regimen containing emtricitabine, elvitegravir, cobicistat and GS-7340.

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