Bristol-Myers Squibb (BMY) Q1 2012 Earnings Call April 26, 2012 10:30 am ET Executives John Elicker - Investor Relations Executive 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
First, before we get started, let me take care of the legal requirements. 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 on our website.Lamberto? Lamberto Andreotti Well, thank you, John, and good morning, everyone. We have just completed another good quarter. The external environment is certainly not becoming easier, particularly in Europe. We had challenges across all dimensions, but Bristol-Myers Squibb is staying on course. We continue to execute our strategy in a consistent manner. Our focus remains balance on both short-term results and long-term growth as we keep increasing our sales and earnings, while delivering clinical and regulatory results. Taken together, we started the year from a good position. With respect to sales, we grew by 5%, and this growth was broad-based and included some of our more recent product launches. I was particularly pleased with the performance of our virology franchise and other key in-line brands, including ORENCIA, SPRYCEL and ONGLYZA. For YERVOY, we had strong stable demand in the U.S., and I am particularly encouraged by improving U.S. trends in recent weeks and increased adoption in the European markets. With respect to regulatory developments, we are moving forward on multiple fronts, 2 of which are especially significant. Regarding FORXIGA, which for those of you who do not know it yet, is the brand name for dapagliflozin, we have received a positive opinion from the CHMP in Europe. We expect the decision on marketing authorization in a few months and together, with AstraZeneca, we are already planning for an eventual launch.
We are glad about this European recognition of FORXIGA's benefit/risk profile for treating type 2 diabetes. And also, by the fact that the agency spoke specifically of the need for additional treatment options, while highlighting the significant unmet medical need in diabetes. We will work with the FDA to clarify a path forward in the U.S., and we continue the regulatory process in all other geographies.Regarding ELIQUIS, we are looking forward to the FDA's upcoming decision on the atrial fibrillation indication, which will hopefully be followed by decisions in Europe and Japan where we have also filed. In partnership with Pfizer, our focus now is on implementing the most effective launch plan. With respect to clinical developments, our pipeline remains robust and encouraging. As discussed at last week's EASL meeting, we are increasingly well positioned to meet the unmet medical need of the 170 million people worldwide who are chronically affected by hepatitis C. The data presented highlighted the broad portfolio of HCV assets that we have today, including a first-in-class NS5A inhibitor and demonstrated our diversified hepatitis C strategy based on multiple mechanism and combinations. Thanks to the acquisition of Inhibitex and its potent nuc, we have broadened our portfolio of investigational HCV compounds and increased the potential opportunities to provide the right regimen for diverse patient populations. This is a high priority for our company, and we are devoting significant resources to it. We are also making good progress with our immuno-oncology late stage pipeline, from our YERVOY development program, exploring additional indications in prostate and lung cancer, to our work with anti-PD-1 and other potential important asset entering Phase III for renal cell carcinoma, non-small cell lung cancer and melanoma. We plan to present data on anti-PD-1 at ASCO. Read the rest of this transcript for free on seekingalpha.com