Bristol-Myers Squibb Company

Stand by. Good day, everyone, and welcome to the Bristol-Myers Squibb 2019 Third Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference to Mr. John Elicker, Senior Vice President, Public Affairs and Investor, excuse me, Industrial Relations. Please go ahead, sir.

Thanks, Augustus, and good morning, everybody. We're here to discuss our Q3 earnings results with me, We have Giovanni Coforio, our Chairman and Chief Executive Officer, Charlie Bancroft, our Chief Financial Officer. They'll both have prepared remarks. Chris Berner, Chief Commercialization Officer, and Dr. Sumit Hirawat, Chief Medical Officer and Head of Drug Development, will be here for Q&A as well. I'll handle the legal requirements first. During the call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. 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 future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of these financial measures to the most comparable GAAP measures are available at our website.

Giovanni? Thank you, John, and good morning, everyone. I'm pleased to speak with you today about another great quarter in which we had strong operating performance, reported significant new data for our oncology franchise, and made important progress to close the pending acquisition of Celgene and integrate the two companies. Let me start with our oncology franchise and the recent results we announced for our lung cancer program. I believe we have an opportunity to play an important role in first-line lung cancer. We now have a second trial demonstrating an overall survival benefit for the combination of Oldevo plus low-dose airway in a first-line lung cancer population, regardless of PD-L1 status or histology. With the results of both Checkmate 9LA and 227, coupled with the strength of our commercial capability, I feel good about our ability to maximize the opportunity we see in the first-line lung cancer market. Let me quickly recap the findings from our two recent lung cancer studies. With Checkmate 227, we've learned that dual IO offers a unique potential for long-term survival in first-line lung cancer. Physicians have told us that the depth and durability of response is important, and we saw a clear contribution of parts when comparing Obdivo plus Yervoy to Obdivo monotherapy in PD-L1 expressors. We also saw that Obdivo plus Yervoy has better overall survival outcomes than the PD-1 chemo combination in PD-L1 negative patients. As we described at ESMO in September, it is our view that the dual IO regimen will play a role in the treatment of first-line lung cancer, and this is supported by the feedback we have received from physicians. We also know that due to rapidly progressing disease, some first-line lung cancer patients need chemotherapy. A key question for the CHECKMATE 9LA study was to determine whether a limited amount of chemo, two cycles, would be enough to stabilize the disease for those patients and manage the early part of the curve, allowing for the potential durability of effect of dual IL. We are pleased with the positive interim analysis from Checkmate 9LA, which demonstrated a meaningful overall survival benefit from our IO combination, concomitant with a limited course of chemo. We expect to report this data at an upcoming medical meeting, likely in 2020. We also look forward to sharing the findings with health authorities soon. At ESMO, We also presented important data that explored new approaches in difficult-to-treat tumors and reinforced the benefit of the Obdivo plus Yervoy regimen. In addition to our first-line lung cancer data, we presented Obdivo plus Yervoy five-year overall survival data in metastatic melanoma. We also presented important data for other types of tumors, including prostate, cervical, and esophageal cancer. We continue to see opportunities to broaden the use of our I.O. medicines to benefit more patients, and the breadth of data presented at ESMO is a good indication of our progress. I'm looking forward to future data readouts in our I.O. development program, including adjuvant beginning next year. As John mentioned, Samit Hirawat is here with us today. He can share his perspective on the full portfolio, as well as his priorities for the development organization during the Q&A. Now, let me turn to the third quarter results. We continued to deliver strong results driven by excellent commercial execution across our portfolio. Our teams have done a great job in a very competitive market for Obdivo, and were able to maintain strong market shares in key indications to date. Eliquis continues to show significant growth, with potential for expansion moving forward. The Eliquis profile is strengthening globally as the product is already established as the global standard of care. This quarter at ECC, we presented the largest real-world data set of French atrial fibrillation patients, which confirmed Eliquis' best-in-class profile. Charlie will provide more color on our performance in the quarter and the potential opportunities that we see ahead. Turning to our transaction with Celgene, I am pleased with the significant progress we've made to bring together two leading innovation companies, united by a shared focus on transforming patient lives through science. While the transaction has been pending, Celgene has continued to deliver on their business priorities. And today, they announced strong results for the third quarter. During the quarter, Celgene made significant progress on the late-stage pipeline. The FDA approved Inrebic or Fedratinib as the first new treatment in nearly a decade for patients with myelofibrosis. We were also encouraged to see the success of Celgene's CC486 study in acute myeloid leukemia patients looking for a maintenance option. I am very proud of the people at Bristol-Myers Squibb and Celgene. Both teams delivered terrific quarters and at the same time made meaningful progress toward closing the transaction and planning for integration. Importantly, we are on track to realize the expected 2.5 billion in run rate cost synergies by 2022. During the third quarter, we achieved two key milestones in the process to close the transaction. We received approval from the European Commission in July. In August, we announced an agreement between Celgene and Amgen to divest Otesla for $13.4 billion in cash, following the close of our acquisition of Celgene. FTC clearance is the remaining regulatory milestone to complete the Celgene transaction. We continue to expect to complete the combination of Bristol-Myers Squibb and Celgene before the end of 2019. In the meantime, we are focused on building the organization structure of the new company with the goal of delivering on the promise of this combination for our patients, our employees, and our shareholders. Following the announcement of my future leadership team in June, we announced internally the next layer of management in September. These leaders are now working on preparing for integration to ensure that we hit the ground running on day one. To conclude my remarks, I'd like to reiterate how pleased I am with our continued strong performance. I'm encouraged by the results we announced in our first-line lung program, reinforcing the benefit of the Obdivo plus low-dose Yervoy regimen and the potential opportunity to provide new treatment options to patients. As we move closer to completing the Celgene transaction, I'm even more excited about the potential of the combined company. Both businesses are performing well. The pipeline is progressing, and we have seen significant clinical and regulatory progress. I am looking forward to more news at ASH. Commercially, we're on track to support multiple future launch opportunities, and I'm confident we are ready for the integration and our ability to execute as a combined company. With that, I'll hand it over to Charmy.