Bristol-Myers Squibb (BMY)
Q3 2012 Earnings Call
October 24, 2012 10:00 am ET
John E. Elicker - Senior Vice President of Public Affairs and Investor Relations
Lamberto Andreotti - Chief Executive Officer, Director, Member of Executive Committee and Member of Science & Technology Committee
Charles A. Bancroft - Chief Financial Officer and Executive Vice President
Giovanni Caforio - President of U.S. Pharmaceuticals
Beatrice Cazala - Executive Vice President of Commercial Operations
Previous Statements by BMY
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Marc Goodman - UBS Investment Bank, Research Division
Jami Rubin - Goldman Sachs Group Inc., Research Division
Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division
Gregory B. Gilbert - BofA Merrill Lynch, Research Division
Mark J. Schoenebaum - ISI Group Inc., Research Division
Catherine J. Arnold - Crédit Suisse AG, Research Division
Steve Scala - Cowen and Company, LLC, Research Division
Seamus Fernandez - Leerink Swann LLC, Research Division
Christopher Schott - JP Morgan Chase & Co, Research Division
Charles Anthony Butler - Barclays Capital, Research Division
David Risinger - Morgan Stanley, Research Division
Good day, and welcome to today's Third Quarter 2012 Earnings Release Conference Call. As a reminder, this call is being recorded. At this time, I'd like to turn the call over to Mr. John Elicker, Senior Vice President, Public Affairs and Investor Relations. Please go ahead, Mr. Elicker.
John E. Elicker
Thank you, Lea, and thanks, everybody, this morning for joining us on the call. I know it's a busy morning for all of you. With me today, we have Lamberto Andreotti, our CEO; Charlie Bancroft, our Chief Financial Officer, with, as you may know, also additional commercial responsibilities. Both Lamberto and Charlie will have prepared remarks. And then joining us for Q&A are Elliott Sigal, our Chief Scientific Officer; and Beatrice Cazala, Executive Vice President of Commercial Operations; and Giovanni Caforio, our President of U.S. Pharmaceuticals business.
So let me take care of the legal requirement. 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. 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 SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any subsequent date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change.
We will also discuss non-GAAP financial measures adjusted to exclude certain specified items. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available at our website, bms.com.
Well, thank you, John, and good morning, everyone. This was a challenging quarter for a number of reasons, and especially due to the discontinuation of the 094 development program. While I am disappointed, very disappointed with that situation, I'm certainly proud of the way we handled it, quickly and decisively to preserve patient safety. Importantly, we remain committed to and focused on delivering against our strategy. Nothing has changed in that regard. We remain fully committed to business development in our therapeutic areas of focus and we remain fully committed to the field of hepatitis C.
Further, a lot happened during the quarter that continues to give me confidence that we are on the right track. The strong performance of our key and new products, the clinical and regulatory advances, particularly those related to YERVOY, anti-PD-1 and ELIQUIS; the simplification of our long-term alliance with Sanofi; and of course, the completion of the Amylin acquisition and the expansion of our alliance with AstraZeneca.
Let me just spend a few minutes on some of these highlights. Commercially, I was encouraged by the performance of a number of key products, namely ORENCIA, SPRYCEL, Baraclude, ONGLYZA and YERVOY, which has experienced solid growth partly due to progress with access and reimbursement abroad. All of these products had a strong quarter, all experienced double-digit growth.
Clinically, immuno-oncology remains a key part of our future and we made progress last quarter on 2 fronts. At the European Society for Medical Oncology, we presented long-term survival data on YERVOY, data that is very important, very valuable for patients with metastatic melanoma. And we also began Phase III trials on anti-PD-1, 2 for lung cancer and 1 for renal cancer. And we are expecting to begin soon, possibly later this year, a Phase III trial for melanoma.
On the regulatory front, there were significantly developments with respect to 2 key products: ELIQUIS and FORXIGA. Regarding ELIQUIS, we received a positive opinion from the CHMP in Europe, and we are expecting a decision by the end of the year. In Japan, our application is progressing and could lead to a decision by the end of the year. And in the U.S., we now have a new PDUFA date on March 17 from the FDA. Regarding FORXIGA, we are hoping for a decision in Europe by year's end, and in the U.S., we now have Klaricid at path forward with the FDA and are planning to resubmit our application by the middle of 2013.
Regarding hepatitis C, we believe we still have some interesting opportunities. Data on some of them will be presented at the AASLD conference next month. And in Japan, we pursue our genotype 1b strategy and expect to file an oral regimen by the end of next year.