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Gilead Sciences (GILD)

Q4 2010 Earnings Call

January 25, 2011 5:00 pm ET


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

Susan Hubbard - Vice President of Investor Relations

John Martin - Chairman of the Board and Chief Executive Officer

John Milligan - President and Chief Operating Officer

Kevin Young - Executive Vice President of Commercial Operations

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


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Ladies and gentlemen, thank you for standing by, and welcome to Gilead Sciences Fourth Quarter 2010 Earnings Conference Call. My name is Stacy and I will be your conference operator today. [Operator Instructions] I would now like to turn the call over to Susan Hubbard, Vice President of Investor Relations. Please go ahead.

Susan Hubbard

Thank you, Stacy, and good afternoon, everyone. Welcome to Gilead's Fourth Quarter 2010 Earnings Conference Call. We issued a press release this afternoon in providing earnings results for the quarter. This press release is available on our website at, as are our slides that provide much more detail around the topics discussed today on this call.

Based on the feedback we've received from many of you that you preferred the approach we introduced last year with more abbreviated prepared comments, we will again keep them brief to allow more time for your questions.

Our first speaker today will be Norbert Bischofberger, Executive Vice President of R&D and Chief Scientific Officer, who will discuss the additional announcement we issued this afternoon, concerning our receipt of FDA's Refuse to File Letter associated with our New Drug Application for the Truvada/TMC278 single tablet regimen.

Following Norbert will be Robin Washington, Senior Vice President and Chief Financial Officer, who will provide financial highlights from the fourth quarter and full year 2010, and provide our 2011 financial guidance, and finally, John Martin, Chairman and Chief Executive Officer, who will discuss our view about the future and opportunities for the company. John Milligan, President and Chief Operating Officer; and Kevin Young, Executive Vice President of Commercial Operations are also here to answer your questions later in the call.

I'd first like to remind you that we will be making statements relating to future events, expectations, trends and 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 statement. 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 any of these forward-looking statements. We will be making certain references to financial measures that are on a non-GAAP basis, and provide a reconciliation between GAAP and non-GAAP numbers in the press release we just issued and on our corporate website. I will now first turn the call over to Norbert to discuss the recent FDA action.

Norbert Bischofberger

Thank you, Susan. As you saw in the press release we issued this afternoon, Gilead received a Refuse to File notification from FDA for our New Drug Application for the Truvada/TMC278 single tablet regimen for the treatment of HIV, which we submitted on November 23 of last year. As many of you already know, once an NDA is submitted, the FDA has up to 60 days to conduct their preliminary review to assess whether the NDA is sufficiently complete to permit a substantive review. If FDA determines the NDA is not sufficiently complete, the FDA will issue a Refuse to File letter.

With the Refuse to File communication we received, FDA refers only to insufficient information in one portion of the chemistry, manufacturing and control section included in our initial submission. Specifically, FDA stated that our application does not contain sufficient information on the analytical methodology used to establish acceptable levels of recently-identified degradants related to emtricitabine.

Our NDA submission referenced that TMC278 single agent NDA submitted by Tibotec on July 23, 2010, which is supported by two pivotal Phase III studies evaluating the safety and efficacy of TMC278 in treatment-naïve HIV-infected patients. Our NDA filing for the Truvada/TMC278 single tablet regimen is supported by a bioequivalence study conducted by Gilead, as well as a section on Chemistry, Manufacturing and Controls or CMC, which includes information on assuring identity, strength, quality and purity of the new drug product and evaluation of the manufacturing process and data from the stability program.

Since our submission and subsequent identification of these degradants, we've been working to validate the analytical methodology that it allows us to accurately quantify these degradants and assure that they are at an acceptable level. We believe that we have accomplished that process, and we will include this information in the refiling of the NDA.

We've had a very positive dialogue with FDA through the review period to date, and we believe this is a minor delay in the potential approvability of this drug. We expect to be in a position to refile the application before the end of the first quarter of this year.

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