Bristol-Myers Squibb Company

Good day, and welcome to the Bristol-Myers Squibb Second Quarter 2024 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to Tim Power, Vice President, Head of Investor Relations.

Please go ahead. Thank you and good morning, everyone. Thanks for joining us this morning for our second quarter 2024 earnings call. Joining me this morning with prepared remarks are Chris Berner, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Linkowski, our Chief Commercialisation Officer, and Sumit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to bms.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll read our forward-looking statement. During this call, we make 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 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 certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com. And with that, I'll hand it over to Chris.

Thanks, Tim, and thanks, everyone, for joining us this morning. Starting on slide four, our second quarter results reflect continued progress against our strategy to position BMS for long-term sustainable growth. In Q2, we continue to strengthen commercial performance with uptake accelerating across a number of our marketing products. Growth portfolio revenues increased 18% year-over-year, or 21% excluding the impact of foreign exchange. This portfolio is on track to be a larger component of our overall mix moving forward. We also advanced our pipeline, demonstrating the strength of our portfolio and the development of our first or best-in-class assets. This includes U.S. regulatory approvals for Breonzi, Crisati, and Octiro. We also achieved a number of milestones this quarter for our IO franchise, including European approval in first-line bladder cancer, presented data at ASCO in first-line liver cancer, and are progressing to a more convenient subcutaneous formulation of nivolumab, where we now have a PDUFA date from the US FDA of December 29th. The EMA is also reviewing our sub-Q application. Before we get into more details around quarterly performance, On slide five, I'd like to step back and take stock of where we are as a company and where we are headed. As discussed previously, we are focusing on reshaping BMS to achieve sustained top-tier growth and maximize long-term value. We're doing this by focusing on three key objectives. First, we are focusing our portfolio on transformational medicines where we have a competitive advantage. This means advancing and, where possible, accelerating first- or best-in-class treatments across our therapeutic areas, prioritizing pipeline assets with meaningful growth potential, and discontinuing programs that no longer meet our threshold for return on investment. Through these actions, we are ensuring our R&D efforts are focused on programs where BMS has a right to win and where we can deliver compelling ROI to shareholders. Second, we are actively driving greater operational excellence throughout the organization. This includes streamlining our operations and focusing the organization on what matters most, becoming more efficient in how we operate, improving R&D productivity, and driving a culture that emphasizes speed and accountability. We're executing on our cost reduction efforts and are on track to achieve the $1.5 billion in cost savings we announced in Q1. Third, we are strategically allocating capital for long-term growth and returns. We remain focused on ensuring we are investing behind our growth portfolio and most critical pipeline assets. Business development and partnerships remain important for us and we continued to strengthen our balance sheet while maintaining our commitment to returning cash to shareholders taken together these actions are ensuring we're focused on the highest value activities across the organization tightening our execution where needed and accelerating our ability to deliver important medicines to patients on that note Turning to slide six, our objective of generating top-tier growth requires us to deliver on the potential of our pipeline. In hematology oncology, we're driving leadership by extending our IO business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals. In cardiovascular, we are leveraging decades of expertise to deliver new treatment options in thrombosis, heart failure, and cardiomyopathies. In immunology, we're focusing our R&D efforts on therapies that reset the immune system with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with CAR-XT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance nicely. On slide seven, let me update you on our progress with CAR-XT specifically. We have two main objectives, preparing for the upcoming launch and executing against a robust clinical program to expand this important therapy into multiple indications. We are rapidly building out the necessary infrastructure ahead of CAR XT's anticipated FDA approval in late September. We're excited about the commercial potential for this product. Adam can speak more about our launch prep in Q&A. As previously discussed, we are also expanding CAR XT to additional indications with data expected in adjunctive schizophrenia in 2025 and Alzheimer's disease psychosis in 2026. Our plans to start trials in both Alzheimer's agitation and bipolar disorder are on track. Finally, we have also initiated planning for two new indications for this product in autism spectrum disorders and Alzheimer's cognition. On slide 8, I want to highlight a few important pipeline milestones across our therapeutic areas this year. In hematology oncology, we're extending our IO franchise with nivolumab sub-Q and lung data for Opdulag. With the anticipated launch of the subcutaneous formulation of nivolumab at the end of this year, we continue to estimate that at least 30 to 40 percent of U.S. patients being treated with IV will convert to the more convenient subcutaneous administration across multiple indications. This ultimately allows patients to benefit from the standard of care cancer medicine into the next decade. With OptuLAG, we plan to share Phase II proof-of-concept data soon. This supports initiation of a Phase III study in a subset of patients with first-line non-small cell lung cancer later this year. In immunology, we expect to see data this year for CD19 NextT. By resetting the immune system, we believe this therapy can deliver meaningful benefits for patients across multiple indications. We have also completed enrollment of our two Phase III trials for SOTIC2 in psoriatic arthritis and now expect to see data later this year. Looking ahead, on slide 9, we will begin to see important data readouts for our pipeline in the second half of this year with momentum building through 2026. A few to focus on include LPA1 in pulmonary fibrosis, our registrational multiple myeloma pipeline including GPRC5D cell therapy, and our cell mods ibernamide and mesignamide And of course, Milvexian, which has the potential to be the only oral factor 11A inhibitor in atrial fibrillation. All have the potential to deliver significant benefits for patients and form a large commercial opportunity for the company. With increasing pipeline momentum, we are confident in our ability to further strengthen our growth profile. Let me close with our outlook on slide 10. Given the strength of our Q2 results and the confidence we have in the remainder of the year, we now expect to deliver... top-line growth at the upper end of our guidance range. We are also raising our guidance range for full-year EPS. David will discuss these updates in more detail shortly. Let me summarize by noting that in Q2, we took notable steps forward on our journey to drive sustained long-term growth. While there is more work to do, We are strengthening the foundation for that growth by progressing what is a catalyst-rich pipeline, growing our commercial portfolio, and maintaining a strong balance sheet that provides strategic flexibility. I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster. Let me now hand it over to David.