Bristol-Myers Squibb Company

Welcome to the Bristol-Myers Squibb Third 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. 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 Chuck Triano, Senior Vice President and Head of Investor Relations. Please go ahead.

Thank you and good morning, everyone. We appreciate you joining our third quarter 2025 earnings call. With 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 is Adam Lankowski, our chief commercialization officer, and we welcome Christian Massachesi, our recently appointed 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 third quarter earnings call. Q3 was another strong quarter reflecting focused execution across the business as we continue to make progress on our plan to position Bristol Myers Squibb for long-term sustainable growth. Building on the momentum from the first half of the year, we saw continued strong demand across our growth portfolio, achieved positive clinical and regulatory milestones, and further aligned our cost structure with the needs of our business. Let me start with a high-level review of our quarterly performance on slide four. Our growth portfolio delivered another strong quarter with sales increasing 17% year-over-year, strengthening the foundation we're building with assets that are early in their lifecycle. Growth was driven by multiple products, including our I.O. portfolio, Reblazil, Chemzios, and Brianzi. And due to our strong performance to date, we are again raising our top-line guidance and maintaining the midpoint of our bottom-line guidance. David will provide more details shortly. Our two recent launches performed well in Q3. Coventry is delivering steady growth as we continue to receive positive feedback from physicians on key indicators supporting our expectation that this is a meaningful first indication for Coventry. Qvantix launch is also tracking well. From a clinical and regulatory standpoint, I want to highlight a few recent updates. On the clinical data side, in our protein degradation platform, the Phase III Excalibur study for ibertamide in patients with relapsed or refractory multiple myeloma demonstrated a statistically significant improvement in MRD negativity rates. Now that we have these results in hand, we will be discussing these compelling data and potential paths forward with health authorities. The trial will continue to evaluate PFS, which is expected in 2026. CellMods have the promise to be a new foundation in the treatment of hematological malignancies. More broadly, our multi-pronged protein degradation platform has the opportunity to also address solid tumors, initially with our oral androgen receptor ligand directed degrader, among others. At the World Lung Conference last month, we presented Phase II data for Pumidamig with our partners at BioNTech. The clinical development program is both advancing and broadening for this important asset. Last month, we initiated the pivotal triple-negative breast cancer study and plan to share early data at the San Antonio Breast Cancer Symposium in December. Additionally, pivotal studies for Pramidamig and chemotherapy combinations are now initiating in first-line microsatellite-stable colorectal cancer and first-line gastric cancer. This week, we announced encouraging data at the American College of Rheumatology Convergence Conference, which continued to strengthen our conviction behind CD19 Next T in autoimmune diseases and SOTIC2 in rheumatology. We presented additional follow-up data for CD19 NextT in both lupus and scleroderma and presented the first disclosure of data in myositis. For SOTIC2, the long-term extension data from the Phase 2 Paisley study continues to validate its potential in lupus as we look forward to Phase 3 results. On the regulatory side, we achieved several milestones, which include our potential first-in-class bispecific ADC isobren receiving breakthrough therapy designation for previously treated advanced EGFR-mutated non-small-cell lung cancer. And earlier this month, the FDA granted fast-track designation to our anti-Tau antibody for the treatment of Alzheimer's disease, currently in a phase two study with data expected to read out in 2027. Together, these milestones highlight the potential of our pipeline to both enhance and sustain growth in the outer years by addressing critical areas of unmet need and the importance of advancing these programs quickly and efficiently. On the business development front, we recently announced we are acquiring Orbital Therapeutics to strengthen our cell therapy franchise, where we have industry-leading expertise. This acquisition will add a potential off-the-shelf, best-in-class asset, OTX 201, which can be administered in the community setting. This in vivo CAR-T represents a novel treatment approach that could redefine how we treat autoimmune diseases. We will also gain access to Orbital's differentiated RNA technology platform, which combines various RNA engineering and advanced delivery methods. In addition, we saw progress with our partner, Cystimmune, as we announced that the first patient was treated in the global Phase 2-3 trial of Isobrine in previously untreated triple-negative breast cancer ineligible for anti-PD-L1 drugs. In August, we closed the previously announced licensing agreement with Phylochem for exclusive worldwide rights to OncoACP3, potential best-in-class radiopharmaceutical therapeutic and diagnostic agent, with the opportunity to become a breakthrough treatment for prostate cancer. We continue to be excited about the overall opportunity with radiopharmaceuticals and believe Fiocam added to RAISE offer a transformational platform for cancer treatment. In terms of progress, we opened a U.S. manufacturing hub with the ability to deliver RAISE's next-generation radiopharmaceutical therapies directly to patients within just three days of production, a critical advantage due to the short shelf life of RPTs. The facility is currently manufacturing clinical doses of RAISE-101, which is in phase three clinical trials for GEP-Nets. Moving on to key data catalysts on slide five. As we've said before, we are entering a data-rich period. We continue to anticipate data readout for ADEPT-2 by the end of this year, and have two additional CoBINFI studies in Alzheimer's disease psychosis, both of which are expected to read out next year. We anticipate needing two of these three studies to read out positively to support regulatory approval. The pace of pivotal readouts will accelerate in 2026. As a reminder, over the next 12 to 24 months alone, We expect data for seven new molecular entities and seven meaningful lifecycle management opportunities. Among others, we will see data for admilparant and IPF, a fatal lung disease with high unmet need, cell mods ibertamide and mezignamide, which represent a significant step forward in the treatment of multiple myeloma, the broad milvexian program, where we are running three large phase three trials, to address ongoing unmet needs for patients with cardiovascular disease, including an AFib trial that could potentially open treatment to at least the 40% of AFib patients not suitable for factor XAs today, CoBENFI in a broad range of Alzheimer's-related neuropsychiatric conditions, and SOTIC2 in lupus and Sjogren's. Together, these represent an attractive set of near-term catalysts that can further shape our pipeline and longer-term growth trajectory, given the significant commercial potential of these indications. And looking out a bit further, by the end of this decade, we have the potential to introduce 10 new medicines to the market and at least 30 significant lifecycle management opportunities. This strategy is designed to set BMS on a clear path of strong and sustainable growth, which remains our guiding principle. Beyond the specific commercial and R&D highlights, the company continues to focus on strong financial discipline. Consistent with prior quarters, while we generated significant cash flow in the third quarter, we also continue to be prudent in managing our expenses as we align our cost structure with the projected shape of our business. In addition, we progressed our efforts in the quarter to rewire how we operate, including continuing to integrate digital technology and AI across the company. We anticipate these efforts will drive additional efficiencies going forward and significantly enhance the agility of the organization. So what does this mean? Between our growth portfolio performance, the business development activity I just referenced, including the BioNTech partnership, and combined with our broad pipeline and strong financial discipline, we feel even better about our longer-term growth potential. I want to take a moment and thank my colleagues around the globe who are committed to our mission to discover, develop, and deliver innovative and life-changing medicines to patients. With that, I'll turn it over to David.