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5/7/2020
Good day and welcome to the Bristol-Myers Squares Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead.
Thanks, Chloe, and good morning, everyone. Thanks for joining us this morning for our first quarter. With me this morning with prepared remarks are Chief Executive Officer and David Elkins, our Chief Financial Officer, also participating in today's call for the Q&A. session are Chris Berner and Sumit Hirawat, our Chief Medical Officer and Global Drug Development. As you'll note, we've posted slides to BNS.org, David and Giovanni's remarks. Before we get started, I'll read our forward-looking statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by those forward-looking truths, including those discussed in the company's SEC filings. These forward-looking truths, as of today, should not be relied upon as representing our estimates as of any future date. We specifically explain any obligation to update forward-looking statements, even if our estimates change, or non-GAAP financial measures which were adjusted to exclude certain specified items. Reconciliations of those non-GAAP financial measures to the Most comparable gap measures are available at bms.com.
Thank you, Tim, and good morning, everyone. I hope that you and your families are healthy and managing safely through these unprecedented times. The COVID-19 pandemic is profoundly impacting our lives, families, and in the last months, our company has focused on how we can help and effectively continue the supply of our medicines to patients globally, while play safety of our workforce. Teams around the world have risen to the challenge. During this pandemic, it has been abundantly a critical role in the prevention. have turned to us to identify and develop the diagnostic tests, effective treatments, and vaccines to prevent the knowledge, development expertise, and manufacturing capabilities are what will ultimately help us prevail. On slide four, let me start with what Bristol-Myers Squibb is doing to support the COVID, the global COVID response in four key areas, our science, our communities, our on the R&D front, we have identified approximately 1,000 compounds in our discovery library that we are making available globally to screen for potential molecules to treat COVID-19, certain medicines in our portfolio that could be included in near with a focus on the inflammatory COVID-19. We are also participating in cross-industry groups designed to foster collaboration. The Foundation COVID-19 Therapeutics Accelerator, the California, the National Institutes of Health, among others. First, our resources on how we can Bristol-Myers Squibb Foundation has provided over 170 grants to human service organizations and countries around the world in order to address gaps in the response to COVID-19. We have equipment to healthcare providers on the front lines in China, Italy, and the U.S. And very important to support our patients. We have expanded our existing patient and employed patients in the U.S. who have lost their health insurance due to the pandemic by offering access to any branded Bristol-Myers Square. We are working with healthcare providers in new ways through effective virtual engagements to ensure to treat their patients while minimizing potential spread of COVID-19. We adjusted our clinical trial operations where patients providers and our employees and to avoid stressing the overall healthcare system all clinical trial activities end of the year where local contrary although the impact on evaluated fully recruit the trials are at lower risk of delays across the globe. First, our essential workers continue to work at our sites to ensure our medicines reach patients who depend on them. Most of our people are working from home to keep essential workers safe and we are supporting our teams with increased flexibility to ensure care for those at home. Our employees who are licensed healthcare workers and wish to volunteer to provide medical services to patients during the pandemic are supported with full salary and benefits. Now, turning to the quarter. We had excellent performance financially and from a pipeline perspective. Ordinary pipeline execution in the first quarter on slide five. Very well on all key Starting with approvals, in late March, Ziposia was approved in the U.S. multiple sclerosis with a best-in-class label. And we also received a positive CHNP Ziposia in Europe. In April, we received FDA approval for Reblozil in MDS. This is the second indication for this medicine. The opportunity we have with this first to treat anemia. Additionally, we just announced a CHMP positive opinion for Reblosil for both beta-tactile and MDS in Europe. With respect to submission, priority review for Lysosil in FOMA in the U.S. Now, with the PDUFA rate extended to November 16. We completed our FDA submission for Idacel. which is an exciting next step in bringing the first CAR-T candidate to adult patients with multiple myeloma. And we very recently announced a new review for CC486 in first-line AML. With respect to lung cancer, we received a priority review in the U.S. and CHMP validation in the EU for Checkmate 9LA for Obdivo plus Yervoy plus Limited Chemo in first-line lung cancer. And we're looking forward to Checkmate 227 next week. Lastly, from a clinical research perspective, we recently reported positive top-line results from two positive pivotal Phase III studies in our IO pipeline. Checkmate 9ER, evaluating Obdivo in combination with Cabometics in first-line RCC, and Checkmate 743, where Obdivo plus Yervoy demonstrated survival benefit in first-line mesothelioma. We look forward to working with global health authorities to bring these new combination regimens to patients who are waiting for new treatment options. This has been a truly remarkable quarter. All of these exciting accomplishments would not have been possible without the focus and dedication of our global teams. Moving to slide six, we've had a very good quarter financially, despite the emergence of the pandemic. Our business is strong. In the first quarter, we delivered $10.8 billion in sales. Related buying patterns, this represents a pro forma underlying growth of 8% versus last year. Our performance was strong across brands and geographies. as a result of excellent commercial execution across the board. David will provide more details in his remarks, including the shifts we're seeing in buying patterns for some of our medicines. Let me now provide more details on how we are managing the business in the current environment. Our supply chain remains intact. We are continuing to manufacture API without disruption, and we have safety stock of raw materials and finished product. It has naturally caused some logistic complications and we are navigating this successfully. Our integration work is proceeding well. We continue to build on the hard work from 19 that allowed us to hit the ground running, operate with great efficiencies. We've seen an acceleration in the cultural cohesion of our new company during the work from home period. as the current environment has brought us together in even greater ways. We are on track to deliver 2.5 billion in synergies by the end of 2022. Finally, as we see countries moving to phase two of the pandemic and reopening parts of their economies, our focus has shifted to recovery, and we are accelerating planning for restart of many of our operations. We will do this gradually as conditions evolve, while continuing to keep the safety and health of our workforce, our patients, and our communities as our highest priorities. So looking forward, while industry-wide dynamics may create volatility in our business in the short term, and there is significant uncertainty regarding the dynamics of the evolution of the pandemic, we are executing well. We remain well positioned, and I am excited about the potential of the company. With that, I'll hand it over to David to walk you through our financials for this quarter and how we are thinking about our future. David?
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