Bristol-Myers Squibb (BMY)
Q2 2010 Earnings Call
July 22, 2010 10:30 am ET
Beatrice Cazala - Member of Management Council, President of Global Commercialization and President of Europe Operations
Previous Statements by BMY
» Bristol-Myers Squibb Q1 2010 Earnings Call Transcript
» Bristol-Myers Squibb Company Q4 2009 Earnings Call Transcript
» Bristol-Myers Squibb Co. Q3 2009 Earnings Call Transcript
Elliott Sigal - Chief Scientific Officer, Executive Vice President, Member of Management Council, Member of Executive Committee, Member of Science & Technology Committee and President of Research & Development
Lamberto Andreotti - Chief Executive Officer, President, Chief Operating Officer, Director, Member of Management Council, Member of Science & Technology Committee and Member of Executive Committee
Charles Bancroft - Chief Financial Officer and Member of Management Council
Tony Hooper - Member of Management Council and President of Americas Operations
John Elicker - Investor Relations Executive
John Boris - Citigroup Inc
Tim Anderson - Bernstein Research
Jami Rubin - Goldman Sachs Group Inc.
Steve Scala - Cowen and Company, LLC
Christopher Schott - JP Morgan Chase & Co
Seamus Fernandez - Leerink Swann LLC
Charles Butler - Barclays Capital
Good day, and welcome to today's Second Quarter 2010 Earnings Release Conference Call. [Operator Instructions] At this time, I'd like to turn the call over to Mr. John Elicker, Vice President, Investor Relations. Please go ahead, Mr. Elicker.
Thanks, Jennifer, and good morning, everybody. Thanks for joining us. We're here to discuss our second quarter results. You've seen the release out this morning. With me today for prepared remarks are Lamberto Andreotti, our Chief Executive Officer; and Charlie Bancroft, our Chief Financial Officer. After the prepared remarks, we'll go to Q&A. And also joining us for Q&A are Elliott Sigal, Head of R&D; as well as Beatrice Cazala; and Tony Hooper, our two Commercial leads.
Before we get started, let me take care of the legal language. During this call, we'll make statements about the company's future plans and prospects, that constitute forward-looking statements for purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's most recent annual report on Form 10-K and reports on Form 10-Q and Form 8-K. These documents are available from the SEC, the Bristol-Myers Squibb website or from BMS Investor Relations.
In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our estimates change.
During the call, we'll also discuss certain non-GAAP financial measures, adjusted to include certain costs expenses, gains and losses and other specified items. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available on our website.
Well, thank you, John. Good morning, everyone. We have completed another quarter in which our efforts have been successfully devoted to the key elements of our strategy: Profitable and quality growth, driven by an innovative and diversified portfolio and pipeline; productivity; attention to balance sheet and capital structure; and fulfillment of the expectations of shareholders, customers and employees.
Our solid second quarter financial results, along with the progress we are making in advancing our pipeline clearly demonstrated our focus and contributes not only to positive short-term performance, but also establishes a strong foundation for future growth and future profitability.
Our performance is good despite the headwind resulting from the implementation of the healthcare reform in the U.S. and from the economic crisis in Europe. Both had an impact on our prices and our earnings, and Charlie, later on, will speak more about these impacts in his comments.
For my part this morning, I would like to talk mostly about the significant data reported over the past several months for both in-line and pipeline products. They reinforce the confidence we have in our extremely productive R&D as a key pillar to continue to build the new biopharma company that we are becoming. The news from ASCO [American Society of Clinical Oncology], ADA [American Diabetes Association] and elsewhere was encouraging for several key molecules, including ipilimumab for metastatic melanoma, SPRYCEL for first-line CML, dapagliflozin for Type II diabetes and apixaban for strong stroke prevention in atrial fibrillation.
ASCO was a very successful meeting for us this year. First, we presented positive data for ipilimumab from Study 020, in second-line metastatic melanoma. This study demonstrated a significant improvement in overall survival at both one and two years. Based on this data, we have submitted our filing in both Europe and the U.S. The EU filing has been validated, while we are waiting for the acceptance of the BLA [Biologics License Application] in the U.S.
In addition, based on the results of the positive Phase II study, we also decided to initiate Phase III development in non-small cell lung cancer later this year. As a reminder, ipilimumab is already in Phase III for the adjuvant treatment of melanoma for prostate cancer.
Also at ASCO, in the head-to-head trial comparing SPRYCEL to GLEEVEC in first-line CML, the primary endpoint was met, with SPRYCEL demonstrating superior efficacy compared to GLEEVEC in complete cytogenic response at 12 months. SPRYCEL also showed significantly higher rates of major molecular response, as well as faster responses versus GLEEVEC. Our submission in Europe has been validated and in the U.S., we have been granted a priority review, with an action date of October 28. For the second-line indication that is already approved, we now have positive four-year follow-up results for both overall survival and progression free survival.