Bristol-Myers Squibb (BMY)
Q4 2011 Earnings Call
January 26, 2012 10:30 am ET
Charles Bancroft - Chief Financial Officer, Executive Vice President and Member of Management Council
Giovanni Caforio - President of U.S. Pharmaceuticals
Beatrice Cazala - Executive Vice President of Commercial Operations
Previous Statements by BMY
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Lamberto Andreotti - Chief Executive Officer, Member of Management Council, Director, Member of Science & Technology Committee and Member of Executive Committee
John Elicker - Investor Relations Executive
Charles Anthony Butler - Barclays Capital, Research Division
David Risinger - Morgan Stanley, Research Division
Mark J. Schoenebaum - ISI Group Inc., Research Division
Seamus Fernandez - Leerink Swann LLC, Research Division
Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division
Jami Rubin - Goldman Sachs Group Inc., Research Division
Christopher Schott - JP Morgan Chase & Co, Research Division
John T. Boris - Citigroup Inc, Research Division
Catherine J. Arnold - Crédit Suisse AG, Research Division
Good day, and welcome to today's Bristol-Myers Squibb 2011 Fourth Quarter Earnings Conference Call. This call is being recorded. At this time, I would like to turn the call over to Mr. John Elicker, Senior Vice President, Investor Relations. Please go ahead, Mr. Elicker.
Thank you, Alicia, and good morning, everybody. Thanks for joining us on the call today to discuss our fourth quarter results. Joining me this morning are Lamberto Andreotti, our Chief Executive Officer; Charlie Bancroft, our Chief Financial Officer, and they'll have prepared remarks. And then joining also for Q&A, Elliott Sigal, our Chief Scientific Officer; Beatrice Cazala, our Commercial Lead for Global Commercialization, as well as responsibility for Europe; and Giovanni Caforio, who runs our U.S. business.
Before we get started, I'll 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 8-K. These documents are available from the SEC, the BMS website or from Bristol-Myers Squibb 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 to these non-GAAP financial measures to the most comparable GAAP measures are available on the company's website.
Thank you, John, and good morning, everyone. Well, we have just completed a very good, very important year for us, one during which we delivered solid result while setting the stage for a strong future. We grew our sales by 9%, and we are very proud of the performance of our innovative and diversified portfolio, as exemplified by the growth of many of our key brands like ORENCIA, SPRYCEL, BARACLUDE, ONGLYZA and YERVOY. We made some promising advances, with respect to our pipeline, the most important of which were those regarding ELIQUIS. And I believe we continue to be good stewards of shareholder capital as we executed multiple strategic transactions, while at the same time, we increased our dividend and continued our share repurchase program.
Two of the most notable development in 2011 concerned YERVOY and ELIQUIS. As you will recall, YERVOY was launched in the U.S. in March with a broad indication for therapy for metastatic melanoma with a significant overall survival benefit demonstrated in 2 Phase III studies.
YERVOY was also approved in Europe and launched in a number of countries there including Germany, while we are working through the process of access and reimbursement in the rest of the region. The safe performance of YERVOY definitely proves a significant success -- a significant acceptance by the oncologist community.
With respect to ELIQUIS, the big news came over the summer with the announcement of the ARISTOTLE study results. The ARISTOTLE results demonstrated its superiority of ELIQUIS we were referring with respect to both safety and efficacy in patients with atrial fibrillation. In fact, it was a triple win, and that the study demonstrated a significant reduction in stoke, bleeding and mortality, making ELIQUIS the only new oral anticoagulant to show a significant reduction in all these 3 areas. This reinforced the earlier AVERROES study, which demonstrated that superiority of ELIQUIS to aspirin regarding efficacy with no increase in the risk of bleeding.
We are preparing the launch of ELIQUIS as we are expecting regulatory decision this year on the atrial fibrillation indication in both the U.S. where the PDUFA date is March 28 and in Europe. We've also filed it in Japan and various other countries.
Taken altogether, the sales, launches, the business transactions and the clinical advances, 2011 was certainly a great year in the life of our company. That said, with all these positive events, the nature of our business often entails setbacks, too. The complete response letter concerning dapagliflozin received last week from the FDA is a case in point. We are very disappointed by this FDA decision as we remain confident in the benefits risk balance of dapagliflozin, and we know there's a big unmet medical needed in diabetes that requires new therapies. We are committed to working through the approval processes with the health authorities here in the U.S. and around the world.