Source: Seeking Alpha
Gilead Sciences, Inc. (NASDAQ:GILD)
Q2 2014 Earnings Conference Call
July 23, 2014 05:00 PM ET
Patrick O’Brien – VP, IR
John Martin – Chairman and CEO
John Milligan – President and COO
Norbert Bischofberger – EVP, Research and Development and CSO
Paul Carter – EVP, Commercial Operations
Robin Washington – EVP and CFO
Geoff Meacham – JPMorgan
Geoffrey Porges – Bernstein
Mark Schoenebaum – ISI Group
Brian Abrahams – Wells Fargo
Matthew Roden – UBS Securities
Michael Yee – RBC Capital Markets
Phil Nadeau – Cowen & Company
Yaron Werber – Citi
Ian Somaiya – Nomura Security
Ravi Mehrotra – Credit Suisse
Robyn Karnauskas – Deutsche Bank
Josh Schimmer – Piper Jaffray
Howard Liang – Leerink
Brian Skorney – Robert W Baird
Matthew Harrison – Morgan Stanley
Thomas Wei – Jefferies & Company
Terence Flynn – Goldman Sachs
Ladies and gentlemen, thank you for standing-by and welcome to the Gilead Sciences’ Second Quarter 2014 Earnings Conference Call. My name is Samiya, and I will be your conference operator today. At this time, all participants are in a listen-only-mode and as a reminder this conference call is being recorded.
I would now like to turn the call over to Patrick O’Brien, Vice President of Investor Relations. Please go ahead.
Patrick O’Brien – VP, IR
Thank you, Sam. Good afternoon, everyone. We issued a press release this afternoon providing earnings results for the second quarter, which is available on our Web site where you can also find detailed slides that support today’s call.
For our prepared remarks and Q&A, I am joined by our Chairman and Chief Executive Officer, John Martin; our President and Chief Operating Officer, John Milligan; our Executive Vice President of Research & Development, Norbert Bischofberger; our Executive Vice President of Commercial Operations, Paul Carter; and our Executive Vice President and Chief Financial Officer, Robin Washington.
Before we begin our formal remarks, we want to remind you that we will be making forward-looking statements, including plans and expectations, with respect to our product candidates and financial projections, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause our actual results to differ materially from these statements. A description of these risks can be found in our latest SEC disclosure documents and recent press releases.
In addition, Gilead does not undertake any obligation to update any forward-looking statements made during this call. We will also be using non-GAAP financial measures to help you understand our underlying business performance. The GAAP to non-GAAP reconciliations are provided in our press release as well as on our Web site.
I would now like to turn the call over to John Martin.
John Martin – Chairman and CEO
Thank you, Patrick, and thank you all for joining us today. I am pleased with our progress and would like to highlight a number of key milestones achieved during the quarter. Just today the U.S. Food & Drug Administration approved Zydelig for the treatment of three B-cell malignancies, chronic lymphocytic leukemia, follicular B-cell lymphoma and small lymphocytic lymphoma. Zydelig is the first in our new class oral medicines that targets PI3K delta and we are pleased to provide this additional treatment option for patients.
Moving to hepatitis C, the rapid adoption of Sovaldi reflects wide spread recognition across the medical community as the benefits of this break through products can brings two patients suffering from hepatitis C. Since approval more than 70,000 patients in United States and 10,000 patients in the EU have been treated with Sovaldi containing regimens. Sovaldi offers higher cure rates with shortened treatment duration at a cost that is comparable to that of alternative treatment options and for many patients who have failed treatment with older regimens Sovaldi provides a new possibility for a cure.
Gilead has generated and is continuing to generate clinical data that support the scientific and medical evidence for treating hepatitis C as many stages of the disease. In fact across all our hepatitis C clinical studies over 6,000 patients have been treated and cured to-date.
In Japan our new drug application has been submitted to Japan’s pharmaceutical and medical devices agency for approval of sofosbuvir in combination with ribavirin for the treatment of genotype 2 infected patients. In the Phase 3 study supporting this application, 97% of patients, dose for 12 weeks with sofosbuvir ribavirin achieving an SVR12, this filing represents Gilead’s first drug application in Japan and they have approved Sofosbuvir would be the first product to be launched and marketed by Gilead in that country.
Our innovation and investment in improving the treatment for hepatitis C continues with the single tablet regimen of ledipasvir/sofosbuvir for patients infected with genotype 1 hepatitis C virus. FDA has assigned a PDUFA date of October 10th and the European Union approval is expected to come later in this year.
In Japan the ledipasvir/sofosbuvir marketing authorization application will be filed in the fourth quarter of this year. This application will be supported by results of a Phase 3 clinical trial conducted in Japan in which genotype 1 infected patients were treated with ledipasvir/sofosbuvir with or without ribavirin for 12 weeks. 22% of the patients have cirrhosis. Overall the SVR12 rate was 99% and the cohort that received ledipasvir/sofosbuvir without ribavirin the SVR rate was 100%.
Ensuring patient access to Sovaldi and all our medicines has been and will continue to be a top priority for Gilead. And we have been actively engaging with payors compelling the benefits of Sovaldi. In addition, we are committed to making Sovaldi available to patients in developed countries and have recently entered agreement with Egypt a country that has the highest presence of hepatitis C in the world.