Bristol-Myers Squibb Company

Hey, and welcome to the Bristol-Myers Squibb 2019 Fourth Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. John Elgar, Senior Vice President, Public Affairs and Investor Relations. Please go ahead, sir.

Good morning, Anna, and thanks, everybody, for joining us today as we talk about our quarter and, importantly, the outlook for 2020 and beyond. I'll take care of the legal requirements before I turn it over to Giovanni, both Giovanni and David Elkins. Our CFO will have prepared remarks and then joining us for Q&A as well are Salmat Hirawat, our Chief Medical Officer and Head of Development, Chris Berner, Chief Commercialization Officer, and Nadeem Ahmed, our President of the Hematology Business. 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 our estimates change. We will also focus our comments on our non-GAAP financial measures which are adjusted to exclude certain specified items. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available at our website. And just to remind everybody, in case you haven't seen them, there are slides to go along with today's call.

And with that, I'll turn it over to Giovanni. Thank you, John, and good morning, everyone. Welcome to our fourth quarter and full year 2019 earnings call. I am pleased to be here today to discuss the earning results of our new company for the first time. On slide four, let me start by reminding you who the new Bristol-Myers Squibb is today. Our mission hasn't changed. We are focused on discovering, developing, and delivering innovative medicines that help patients living with serious diseases. We aspire to be the leading biopharma company in the industry. Our strategic foundation remains centered on combining the scale and resources of a pharma company with the agility and speed of a biotech. I am proud of the strength and talent of our people who are focused on transforming patients' lives through science. Moving to slide five, I am more encouraged about our company's potential today than I was a year ago. The strength of our performance in 19 has positioned us very well for the future. As I look at 2019, we've delivered strong in-line performance across our businesses and geographies, and we've made important progress on our late-stage pipeline. I'm pleased with how integration is going so far, with good progress across our business units and functions, as we remain on track to deliver $2.5 billion in synergies. Of course, we have more work to do to integrate our processes, systems, and platforms, including IT, pricing, and accounting. Based on what I've seen to date, I'm confident about the successful integration of our company. Turning to our financial outlook, I feel really good about the financial strength of the company. Our guidance reflects the earnings power and significant EPS growth outlook that we have as a company. We continue to see potential for significant cash flows to support debt reduction and continued investment in innovation. Finally, as I look forward, we have an unprecedented number of new drug launches in the near-term horizon. These are all either first-in-class and or best-in-class medicines, and I am very encouraged by how prepared our teams are to maximize these launch opportunities. Now, let's move to the fourth quarter. Turning to slide six, I'll give you my perspective before David provides more color on product performance. We've delivered strong growth across multiple key brands, many with double-digit growth. With respect to the IO franchise, I'm pleased with the excellent work of our teams in this area. Opdivo grew on a full-year basis, and though we're seeing some pressure in the U.S., as expected, we saw growth internationally and continue to view 2020 as a year of transition for the brand. Looking forward, we have the potential for new launches, supporting an expected return to growth in 2021. This includes first-line lung cancer with studies 227 and 9LA, our first-line renal cancer opportunity with 9ER, and moving into earlier stage disease with a number of adjuvant opportunities. Regarding lung cancer, Let me talk briefly about Study 227. While we're disappointed by the position taken by the CHMP, we continue to view the combination of Obdivo and Yervoy as a differentiated regimen with the potential for long-term survival and one that should be available to patients globally. Going forward, we continue to focus on the review of Study 227 in the U.S., where it was granted priority with a PDUFA date in May. as well as the filing of 9LA in the U.S. and globally. In summary, I am very encouraged by the strength of commercial execution across the enterprise in oncology, hematology, cardiovascular, and immunoscience. This is a clear demonstration of our leading commercial capabilities, which will be important to deliver on the exciting potential near-term launch opportunities ahead. Let's turn to slide seven. In December, we attended our first medical meeting as a combined company at the American Society of Hematology, just a few weeks after we closed the cell gene transaction. Importantly, we saw very good data dash for our hematology pipeline, including pivotal data for three products which are potentially approaching launch and encouraging data from the early pipeline. I believe that this reinforces the opportunity we have to broaden the hematology portfolio and sustain a leadership position in multiple myeloma. Let's turn to slide eight. I feel good about the earnings power and growth outlook for the company moving forward. I am encouraged by the financial strength of the company this year. We see significant non-GAAP EPS growth from this year into next year, and we project continued non-GAAP EPS growth into 2022. So this will be moderated by the impact of generics on Revlimid. David will provide more details on this guidance, but I am pleased with the strength of our inline business, our launch opportunities, our financial flexibility, and the breadth of our pipeline. And with respect to our launch opportunities, we expect important potential milestones over just the next few months. In March, the U.S. approval of Ozonimod and multiple sclerosis. In April, the expansion of Reblosil in MDS. In May, the U.S. approval of Obdivoplast Yervoy in first-line lung cancer. Additionally, we continue to advance our regulatory filings for Lysosil IDASEL, and CC486. Taken together, the company is in a strong position, and this is reflected in the performance of our business and the outlook we are providing today. Turning to slide 9, to realize our potential, we will continue to deliver on the in-line business, drive integration and synergy capture, maximize the value of our launch opportunities, and advance our pipeline. Beyond this, I continue to be encouraged by our financial strength and flexibility, and how this enables us to continue to invest in innovation to deliver important medicines for patients. All of this is what gives me confidence in our near and long-term opportunities as a company. I'm looking forward to our Investor Day, which will be held on April 2nd in New York City. when my team and I will be able to talk in greater detail about the many opportunities ahead of us. Speaking of my team, I am very pleased to be joined today by David Elkins and Nadeem Ahmed. Welcome to both. At this point, I will hand it over to David, our new CFO, to walk you through the financials.