Gilead Sciences (GILD)
Q3 2011 Earnings Call
October 27, 2011 5:00 pm ET
Robin L. Washington - Chief Financial Officer, Principal Accounting Officer and Senior Vice President
John F. Milligan - President and Chief Operating Officer
Kevin B. Young - Executive Vice President of Commercial Operations
Susan Hubbard - Vice President of Investor Relations
John C. Martin - Chairman of the Board and Chief Executive Officer
Norbert W. Bischofberger - Chief Scientific Officer and Executive Vice President of Research & Development
Andrew Cheng - Senior Vice President of Development Operations
Jim Birchenough - BMO Capital Markets U.S.
Sapna Srivastava - Goldman Sachs Group Inc., Research Division
Brian Abrahams - Wells Fargo Securities, LLC, Research Division
Michael J. Yee - RBC Capital Markets, LLC, Research Division
Rachel L. McMinn - BofA Merrill Lynch, Research Division
Thomas J. Russo - Robert W. Baird & Co. Incorporated, Research Division
Robyn Karnauskas - Deutsche Bank AG, Research Division
Joshua Schimmer - Leerink Swann LLC, Research Division
Bret Holley - Oppenheimer & Co. Inc., Research Division
Ravi Mehrotra - Crédit Suisse AG, Research Division
Geoffrey C Meacham - JP Morgan Chase & Co, Research Division
Maged S. Shenouda - Stifel, Nicolaus & Co., Inc., Research Division
Thomas Wei - Jefferies & Company, Inc., Research Division
Andrew Peters - UBS Investment Bank, Research Division
M. Ian Somaiya - Piper Jaffray Companies, Research Division
Previous Statements by GILD
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Ladies and gentlemen, thank you for standing by and welcome to Gilead Sciences Third Quarter 2011 Earnings Conference Call. My name is Veronica, and I will be your conference operator today. [Operator Instructions] As a reminder, this conference call is being recorded today, October 27, 2011. I would now like to turn the call over to Susan Hubbard, Vice President of Investor Relations. Please go ahead.
Thank you, Veronica. Good afternoon, everyone and welcome to Gilead's Third Quarter 2011 Earnings Conference Call. We issued a press release this afternoon, providing earnings results for the quarter. This press release is available on our website, as are the slides that provide much more detail around the topics covered on today's call.
Your speakers for today will be John Martin, Chairman and Chief Executive Officer; Robin Washington, Senior Vice President and Chief Financial Officer; and Norbert Bischofberger, Executive Vice President of R&D and Chief Scientific Officer. John Martin will review the third quarter milestones, Robin will discuss our financial results and commercial performance and then Norbert will provide an update on our research and development progress and discuss our future outlook and opportunities.
John Milligan, President and Chief Operating Officer, Kevin Young, Executive Vice President of Commercial operations; and Andrew Cheng, Senior Vice President of HIV therapeutics and development operations are here as well, to answer your questions later in the call. I would also like to note that we just issued a press release announcing today's completion of the U.S. NDA filing for our Quad drug. Norbert will discuss this significant milestone in further detail later in the call.
I would like to remind you that we will be making statements relating to future events, expectations, trends, objectives and financial results, that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
These statements are based on certain assumptions and are subject to a number of risks and uncertainties that could cause our actual results to differ materially from those expressed in any forward-looking statements. I refer you to our latest SEC disclosure documents and recent press releases for a detailed description of risk factors and other matters related to our business.
In addition, please note that we undertake no obligation to update or revise these forward-looking statements. We will be making certain references to financial measures that are on a non-GAAP basis. We reconcile GAAP and non-GAAP numbers in the press release we just issued as well as on our corporate website. I will now turn the call over to John Martin to provide the highlights on the quarter.
John C. Martin
Thank you, Susan. I'm very pleased with our progress during the third quarter. First in August, U.S. FDA approved Complera, the second single tablet regimen for the treatment of HIV, combining Truvada with Tibotec's Rilpivirine. Product was shipped to wholesalers and pharmacies within 24 hours of approval. In Europe, this product is called Eviplera, and has received a positive opinion from the CHMP. Before the end of the year, the European Commission is expected to give final approval and launches of Eviplera in various European countries will follow in 2012.
At the September ICAAC conference in Chicago, Complera was the focus of a late-breaker poster, which featured results from study 111, a study designed to assess whether patients can safely switch from Atripla to Complera. The data demonstrated that all 49 patients in the study maintained biologic suppression, 12 weeks after the switch to Complera.
To further define the profile for Complera, we have 2 Phase IIIb studies underway. The first is an open label comparison of Atripla to Complera, to assess the benefits of single tablet regimens, which because of ease, simplicity and convenience, may lead to higher compliance of better biologic outcomes. This 48-week study, is fully enrolled with 799 patients. The second study is designed to support switching from a protease inhibitor containing regimen to the single tablet regimen of Complera.
In this study, 482 patients, fully suppressed on a protease inhibitor regimen were randomized to either continue on their existing regimen or switch to Complera. Also during the quarter, we completed the purchase of the biologics manufacturing facility in certain process development assets, located in Oceanside, California.
This facility is currently designed and equipped to produce biologics for toxilogical Phase I and Phase II clinical studies. We retained many of the site's biologics manufacturing specialists and process development scientists, and will use the facility for the process development and manufacture of GS 6624 and other antibodies currently in preclinical development. This acquisition provides us with the resources and expertise to accelerate internal biologics research and development programs, and to take advantage of external opportunities in the future.