Bristol-Myers Squibb Company

Good day and welcome to the Bristol-Myers Squibb Second Quarter 2025 Earnings Conference Call. All participants will be in a 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. 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 in Hidden Investor Relations. Please go ahead, sir.

Thank you, and good morning, everyone. We appreciate you joining our second 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 Lemkowski, our chief commercialization officer, and Samit 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. Welcome and thank you for joining our second quarter earnings call. In Q2, we continue to make good progress reshaping the company for long-term sustainable growth. I'm pleased with our performance and our financial results speak to that. Building on the momentum from the first quarter, we saw strong demand across our growth portfolio and continue to optimize our cost structure to match the needs of our business. Let's double-click on our quarterly performance on slide four. Our growth portfolio delivered another strong quarter with sales increasing 17% year-over-year primarily driven by demand across all key brands. David will provide more color on our portfolio's performance in his remarks. In addition to strong performance in our growth portfolio, we continue to make regulatory progress across the globe. In Europe, we secured approval for both Opdivo and neoadjuvant lung cancer and for Qvantik across multiple solid tumor indications. Additionally, in the U.S., we appreciate recent actions by the FDA that have resulted in streamlined patient monitoring requirements and the removal of RIMS programs for all cell therapies. This is expected to enable more patients to benefit from these transformative therapies over time. With respect to capital deployment, we announced strategic partnerships with BioNTech to expand and extend our immuno-oncology leadership, as well as with Phylochem to strengthen our radiopharmaceutical business and expand our focus in prostate cancer. I will discuss these deals in a moment. With the results achieved in the quarter, we are again raising our top-line guidance as well as our bottom-line guidance before considering acquired IPR&D charges in the quarter. Our recent launches of CoBinfi and CuVantic are progressing well. CoBinfi has delivered strong performance since launch, and we have consistently received positive feedback from physicians. They are seeing firsthand the medicine's differentiated profile with robust efficacy on both positive and negative symptoms and improved cognition. Regarding the U.S. launch of CuVantic, early feedback is encouraging with strong uptake. Delivering treatment in just three minutes saves time for patients, caregivers, and providers while also improving clinic efficiency, increasing patient comfort, and reducing treatment complexity. Additionally, fewer port procedures streamline care, allowing physicians to treat more patients. Now moving to recent business development initiatives on slide 5. First, we entered into a global strategic partnership with BioNTech to co-develop and commercialize BNT327, a potentially transformative PD-L1 VEGF bispecific that could set a new standard of care across multiple tumor types. We're excited to bring together BMS's deep scientific and clinical expertise, development and regulatory capabilities, and commercial infrastructure in the I.O. space with BioNTech's innovation on BNT327. With a strong partner, we're well-positioned to accelerate existing clinical trials, expedite time to market, and expand the number of indications. The combined capabilities of BMS and BioNTech give us the opportunity to place B&T 327 within the first wave of launches in this arena, either first or second to market, a critical advantage in terms of maximizing the commercial opportunity. B&T 327 has the potential to become another needle-moving IO therapy and accelerate our overall growth trajectory. The partnership is off to a great start. We are well underway in advancing a robust joint clinical development program that expands upon the initial indications by further developing BNT327 in numerous additional tumor types and combination. We look forward to sharing more information in the future. Separately, In terms of our early stage pipeline, we entered into a license agreement with Phylochem for exclusive worldwide rights to OncoACP3. This is a potential best-in-class radiopharmaceutical therapeutic and diagnostic agent with the opportunity to become a breakthrough treatment for prostate cancer. We believe this collaboration will further strengthen our position in the rapidly advancing radiopharmaceutical space. Earlier this week, we announced a transaction with Bain Capital to form a new company focused on advancing innovative immunology therapies. As part of this transaction, we outlicensed five assets to a newly formed company, including three clinical stage compounds and two phase one ready compounds. This deal represents a compelling opportunity to accelerate the development of these promising immunology assets while also allowing BMS to participate in future value creation through royalties, milestone payments, and at roughly 20% equity stake. BMS will continue to have a strong presence in immunology. We are focusing our immunology R&D efforts in areas where the company is best positioned to lead. These strategic BD initiatives demonstrate our ability and flexibility to continually identify opportunities to both source external innovation and also externalize pipeline assets where appropriate. This is all in support of our objectives. of driving improved growth in the outer years and attractive returns for shareholders. Moving to our key data catalysts on slide six. we're entering a data-rich period. In the next 12 to 24 months alone, we expect seven registration assets and seven meaningful lifecycle management opportunities. These represent important needle-moving events that can de-risk the pipeline and help shape our trajectory through the end of the decade. Recognizing we've had a few studies read out this year where results were not as expected, we are reviewing all of our near-term studies to best ensure the timely delivery of these programs with the highest probability of success. While we are encouraged by the overall breadth of our pipeline, I would highlight three new molecular entities with nearer-term data readouts. We expect readouts for milvexian in acute coronary syndrome and secondary stroke prevention next year and for atrial fibrillation in 2027. Data for admilparant and idiopathic pulmonary fibrosis is expected next year, and we're also expecting to see MRD negativity data in-house later this year and PFS data next year from the Phase III Excalibur study of ibertamide. This could provide additional validation of our CellMod platform as a next-generation potential standard of care in multiple myeloma. In terms of lifecycle management, we now have several ongoing registrational trials for cobinfi and Alzheimer's disease patients. These include studies in Alzheimer's psychosis, agitation, and cognition impairment. In addition, we are also enrolling a Phase III study in bipolar I disorder. In addition, we have attractive opportunities to invest in numerous oncology pivotal trials. BNT327 is enrolling in first-line non-small-cell lung cancer and small-cell lung cancer, and a study in first-line triple-negative breast cancer is expected to begin later this year. We're also advancing next-generation platforms that could redefine their respective categories. We are initiating two registrational studies for our PRM T5 inhibitor, one in non-small-cell lung cancer and another in pancreatic cancer based on encouraging early data with additional longer-term non-small-cell lung cancer results to be presented at World Lung. Additionally, we are now recruiting a pivotal study for our EGFR HER3-targeting ADC, isopren, in first-line triple-negative breast cancer and expect early data in non-small cell lung cancer and other solid tumors later this year. Lastly, in immunology, we are also now enrolling patients in a pivotal Phase II study for our CD19 NextT cell therapy in severe refractory lupus. Data readouts are expected to continue next year and throughout the end of the decade, providing an increasing line of sight into the strength of our pipeline. We are investing in and prioritizing areas where we see the strongest potential for high-value assets. We are doing what we said we would do, driving focused execution across the business and delivering solid results as we advance our multi-year plan to emerge as a top-tier sustainable growth company by the end of the decade. Finally, I want to welcome Dr. Christian Massacezzi to BMS, who will be joining us starting tomorrow as Executive Vice President, Chief Medical Officer, and Head of Development. It's a pivotal time to lead our development organization given the number of key pipeline advancements we are making in the months and years ahead, and I look forward to the impact that he will be bringing to our pipeline and the team. I also want to thank Samit for all of his contributions in leadership during his six years at BMS and his commitment to groundbreaking science on behalf of our patients worldwide. With that, I'll turn it over to David.