Bristol-Myers Squibb Company

Good day and welcome to the Bristol-Myers Squibb first quarter 2025 earnings conference call. All participants will be in a listen only mode. Should you need assistance, please signal conference specialists 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. And to withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Mr. Chuck Triano, Senior Vice President and Head of Investor Relations. Please go ahead, sir.

Thank you, and good morning, everyone. We appreciate you joining our first quarter 2025 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 Lankowski, our chief commercialization officer, and Sumit Hirawat, our chief medical officer and head of global drug development. Earlier this morning, we posted our quarterly slide presentation to BMS.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll remind everybody that during this call, we will 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, and 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. Finally, unless otherwise stated, all comparisons are made from the same period in 2024 and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. All references to our P&L are on a non-GAAP basis. And with that, I'll hand it over to Chris.

Thanks, Chuck. Good morning, and thank you all for joining our first quarter earnings call. We had a strong Q1, driven by solid execution across the business and continued focus on our strategic priorities, maximizing our growth portfolio, accelerating our R&D pipeline, driving operational excellence, and strategically allocating capital. Our plans to transition the portfolio to deliver long-term sustainable growth are underway. Today, I will begin with some comments on our first quarter performance and highlight our recent accomplishments. Then I will discuss our pipeline and upcoming catalysts that can further strengthen our long-term growth potential. I'll end by addressing the current operating climate. Starting with performance on slide four, our growth portfolio again delivered double-digit sales growth driven primarily by strength in key marketed products including our IO portfolio, Breonzi, Reblazil, and Chemzios. And as expected, our legacy portfolio performance primarily reflected the impact of generic entries for certain older brands. So turning back to our growth portfolio, let me speak to our recent launches. As you'll recall, in October, we launched COBENFI, the first truly novel mechanism for the treatment of schizophrenia in decades, and we are pleased with the early prescription trends. Patient and physician feedback is very positive, reflecting its favorable tolerability and efficacy profile and noting that patients are observing cognitive benefits. In January, we launched Adivo Qvanti, the subcutaneous formulation of Novolumab, which is also receiving promising early feedback from practices and patients. And based on our performance in the first quarter, we are increasing our top and bottom line guidance. David will provide more details shortly. We continue to advance our pipeline during the quarter with several recent announcements. Opdivo plus Urovoi received FDA and EMA approvals for the treatment of first-line liver cancer and FDA approval for use in MSI-high colorectal cancer in the U.S., further solidifying its leadership in immuno-oncology. Brianzi was approved in the EU for treatment of follicular lymphoma. expanding our cell therapy presence in blood cancers. Chemzios received approval in Japan and a favorable label update in the U.S., which reduces the REMS echo monitoring requirement in the maintenance phase. In addition, Milvexian reached an important milestone in the quarter with the completion of enrollment in the Labrexia atrial fibrillation trial. This event-driven study remains on track to read out in 2027. Turning to slide five and our two recent top-line readouts, while we're disappointed that the Chemzayos-Odyssey study in non-obstructive HCM and the Kobinfi-Arise study in adjunctive schizophrenia did not meet their primary endpoints, I want to put the results in proper context. Although these are not the results that we had hoped for, neither outcome meaningfully alters our strategy or growth trajectory. For CAMSIOs, the study strongly suggests that non-obstructive and obstructive HCM behave distinctly. We do not expect these data to significantly impact peak sales, and our focus remains on our existing obstructive HCM indication, which represents the vast majority of the market opportunity. For COBINFI, although it did not demonstrate a statistically significant improvement as an adjunctive treatment in the ARISE trial, these data are encouraging, showing a noteworthy improvement for the majority of patients, as well as a tolerable safety profile. As we noted earlier this week, we will complete a full evaluation of the Phase 3 trial data and will plan to engage with the medical community and regulators to discuss these results and potential next steps. Also, it's important to remember there are no currently approved adjunctive therapies for schizophrenia. Our commercial strategy remains focused on monotherapy, which accounts for 70% to 80% of the market, where our goal is for COBINFI to become the foundational treatment. As I mentioned earlier, COBINFI's differentiated profile is resonating, and we're seeing strong early uptake. Looking ahead, we're confident in the strength of our portfolio and the breadth of opportunities in our pipeline. We expect several of these opportunities to come this year, such as the first look at one of the phase three trials for COBINFI and Alzheimer's disease psychosis, where there is significant unmet need. We also plan to initiate several new pivotal studies this year, including seven phase three studies for COBINFY across three indications, Alzheimer's agitation, Alzheimer's cognition impairment, and bipolar I, all expected to be underway by mid-year. At the same time, in oncology, we're advancing two next-wave solid tumor programs. First, our EGFR-PER3 antibody drug conjugate, Isobren, is expected to begin enrollment in a pivotal study in first-line triple-negative breast cancer in the coming months. And second, our androgen receptor degrader program in prostate cancer has begun enrolling patients in a pivotal study. We also expanded our registrational program for golcotomide, a potential first-in-class cell mod for lymphoma. The GOAL-SEQ-4 study in second-line plus follicular lymphoma will explore the combination of golcotomide with rituximab, where we know effective, chemo-free regimens are needed for patients. In total, we believe these programs represent significant opportunities over the back half of the decade given the unmet medical need. The numerous pivotal data readouts in the coming years have the potential to meaningfully enhance the long-term strength of our growth portfolio. Our commitment to innovating for patients remains strong as we advance first and or best-in-class medicines, both through internal discovery and business development, which remains a top priority. In terms of BD, we're actively pursuing opportunities that can enhance our growth profile where there's strong strategic alignment in financial rationale. And with our renewed organizational agility and balance sheet in a solid position, we have the flexibility to act decisively when we find the right opportunities. As we've said, maximizing long-term growth starts with strong execution this year and over the midterm. The growth portfolio is performing well and our pipeline is advancing. At the same time, we're taking deliberate actions to right-size our cost structure and become a more efficient company. Overall, I'm confident we will deliver on disciplined execution as we position the company for top-tier growth by the end of the decade. Before I turn it over to David, I'll just say a few words on the current global operating climate. There's a lot of uncertainty, whether related to tariffs, a potential economic downturn, or restructuring at the FDA and HHS. This backdrop notwithstanding, our focus continues to be on building a strong and resilient company that can navigate and manage through operating complexities. We remain confident in our ability to deliver for our patients, employees, and shareholders. Our strategy is clear and we're executing. We have a rich pipeline with strong growth potential. We act swiftly when we see opportunities, whether it's business development to bring in great science or pursuing efficiencies in our business. And finally, we are laser focused on execution, as you can see by our strong performance this quarter. With that, I'll turn it over to David.