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U.S. business Bristol Myers Squibb was founded in the early 1800s and aims to combine the reach and resources of a global pharma company with the entrepreneurial spirit and agility of a biotech firm. European sites in Germany, Ireland, Switzerland, Belgium, France and the U.K. host employees. Global flexibility guidelines aim to optimize working patterns for each individual around their role, family responsibilities, health needs and personal preferences. A sense of purpose runs through the company, from influencing EU policies to philanthropy; an employee giving program, administered by the BMS Foundation, doubles staff's financial contributions to eligible charitable organizations. In 2022 the organization donated £2 million to NHS cancer services, charities and patient groups.

The corporations on our annual list posted aggregate revenues of $41 trillion for the second year in a row.

Industries included in the sector are insurance and managed care, medical products and facilities, pharmacy services, and pharmaceutical companies.

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Modern Board 2023-Bristol Myers Squibb

Last year, the New York–based Bristol-Myers Squibb tied ESG initiatives to executive compensation in a first for the pharmaceutical company. That effort came after a 2022 initiative to have 25% of clinical trials in diverse communities. CEO Giovanni Caforio chairs the 11-member board, of whom 10 are independent directors. Other directors include Peter Arduini, president and CEO of GE Healthcare, and Paula Price, who most recently served as Macy’s chief financial officer. Deepak Bhatt, director of Mount Sinai Heart, is the latest board appointment, tapped for his extensive cardiovascular research and clinical trial expertise. In June, the board <a href="https://www.fiercebiotech.com/biotech/bms-strikes-roche-rivalry-41b-acquisition-turning-point">approved the acquisition</a> of cancer drug company Turning Point Therapeutics for $76 a share in a deal totaling $4.1 billion. The firm is still scouting for new M&amp;A deals, Caforio said in its latest earnings call, as the pharma giant tries to offset a sales loss from two drugs that lost patent exclusivity last year. Also in 2022, the company laid off roughly 170 employees due to redundancies from its 2019 acquisition of Celgene. Women and minorities separately make up 36% of the board. Current chief operating officer Christopher Boerner will succeed Caforio when he steps down in November.

Fortune Modern Board 25

The Fortune 500, in its 69th year in 2023, ranks the biggest U.S. companies by revenue.

F500-2023-095-Bristol Myers Squibb

The New York City–based pharmaceutical giant had a lackluster 2022, dropping 13 spots on the Fortune 500 as its revenue decreased by 0.5% and profits dropped 9.5% from the prior year. 
<ul> 
 	<li>In 2022, Revlimid, a cancer drug, lost exclusivity in the U.S., which allowed generics to eat into its market share. Once a company blockbuster, the drug saw a 22% decrease in revenue from $12.8 billion in 2021 to approximately $10 billion in 2022.</li> 
 	<li>Bristol-Myers Squibb’s other top drugs, Eliquis, an anticoagulant, and Opdivo, used for chemotherapy, brought in 21% and 15% more revenue, respectively, for 2022.</li> 
 	<li>The company faces a steep patent cliff ahead as exclusivity for Eliquis and Opdivo is set to expire in 2028, and BMS is actively investing to find another drug to add to its portfolio, spending $9.5 billion in 2022 on research and development.</li> 
</ul>

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Aggregate sales hit $37.8 trillion last year—an increase of 19%, the highest annual growth rate in the list’s history.

Modern Boards 2022 Bristol Myers Squibb

The board at pharmaceutical company Bristol-Myers Squibb scored high on age dispersion, and for having a high number of senior independent nonexecutive directors. Bristol-Myers Squibb’s board has three current CEOs, including its own, Giovanni Caforio, and Peter Arduini, CEO of GE Healthcare. Also on the board is Derica Rice, former CVS Health EVP and president of CVS Caremark, the pharmacy benefits management (PBM) business. 
 
Though the company is facing a patent cliff, <a href="https://seekingalpha.com/article/4496603-bristol-myers-squibb-on-track">analysts are optimistic</a> that BMS’s strong pipeline and cash flow will help carry the company in the long run. In 2021 BMS brought in <a href="https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Reports-Fourth-Quarter-and-Full-Year-Financial-Results-for-2021/default.aspx">$46.4 billion</a> in revenue, exceeding its annual target and registering 9% year-on-year growth. The company also <a href="https://www.fiercepharma.com/pharma/bristol-myers-ceo-caforio-takes-pay-cut-employee-metric-drags-down-bonus">reported strong</a> performance on supply-chain reliability and COVID-19 response, with a 99% vaccination rate among its employees in the U.S. and Puerto Rico. BMS published its first <a href="https://www.bms.com/about-us/global-diversity-and-inclusion/diversity-and-inclusion-report.html">global diversity and inclusion report</a> in 2021, setting goals to achieve gender parity at the executive level globally and to double the number of Black and Latinx/Hispanic executives in the U.S. by the end of 2022. 
 
BMS <a href="https://news.bms.com/news/details/2022/Bristol-Myers-Squibb-to-Highlight-Long-Term-Growth-Strategy-at-J.P.-Morgans-40th-Annual-Healthcare-Conference/default.aspx#:~:text=Bristol%20Myers%20Squibb%20plans%20to,dividend%20and%20share%20repurchase%20program.">plans to leverage</a> up to $45 billion in free cash flow in the next two years to execute a capital allocation strategy prioritizing business development and returns to shareholders. The company <a href="https://www.marketwatch.com/story/bristol-myers-squibb-sets-5-bln-accelerated-stock-buyback-bmy-271644409304">recently executed</a> a $5 billion accelerated share repurchase agreement during the first quarter, part of a multiyear $15 billion buyback program.

Organizations on this annual list positively impact people and communities across multiple countries.

World's-Best-Workplaces-2022-BMS

World’s 25 Best Workplaces

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The New York City–based pharmaceutical company delivered strong financial results in 2021, with total revenue growing 9% year over year to $46.4 billion. Bristol-Myers Squibb enjoyed strong sales for drugs like Revlimid and Opdivo, used in the treatment of certain cancers; and Eliquis, an anticoagulant. Its product-development pipeline also looks healthy: In 2021, the company obtained more than 20 regulatory approvals for new medicines.

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Total revenue for the world’s biggest companies fell 4.8% to $31.7 trillion this year—the first decline in half a decade.

<span data-sheets-value="{&quot;1&quot;:2,&quot;2&quot;:&quot;The New Jersey–based drugmaker jumped up 40 places on this year’s list—with 62.6% revenue growth—because of the additional sales that came with its $74 billion acquisition of Celgene in 2019. Sales of BMS’s anticoagulant Eliquis and its immuno-oncology drug Yervoy also showed strong growth in 2020. The company won 13 additional drug or formulation approvals in the U.S., European Union, and Japan last year; it also acquired MyoKardia, a biotech focused on cardiovascular diseases, for $13.1 billion in November 2020.&quot;}" data-sheets-userformat="{&quot;2&quot;:12673,&quot;3&quot;:{&quot;1&quot;:0},&quot;10&quot;:2,&quot;11&quot;:4,&quot;15&quot;:&quot;Calibri&quot;,&quot;16&quot;:11}">The New Jersey–based drugmaker jumped up 209 places on this year’s Global 500 list—with 62.6% revenue growth—because of the additional sales that came with its $74 billion acquisition of Celgene in 2019. Sales of BMS’s anticoagulant Eliquis and its immuno-oncology drug Yervoy also showed strong growth in 2020. The company won 13 additional drug or formulation approvals in the U.S., European Union, and Japan last year; it also acquired MyoKardia, a biotech focused on cardiovascular diseases, for $13.1 billion in November 2020.

This year’s Fortune 500 marks the 67th running of the list.

F500-2021-75-Bristol-Myers Squibb

<span data-sheets-value="{&quot;1&quot;:2,&quot;2&quot;:&quot;The New Jersey–based drugmaker jumped up 40 places on this year’s list—with 62.6% revenue growth—because of the additional sales that came with its $74 billion acquisition of Celgene in 2019. Sales of BMS’s anticoagulant Eliquis and its immuno-oncology drug Yervoy also showed strong growth in 2020. The company won 13 additional drug or formulation approvals in the U.S., European Union, and Japan last year; it also acquired MyoKardia, a biotech focused on cardiovascular diseases, for $13.1 billion in November 2020.&quot;}" data-sheets-userformat="{&quot;2&quot;:12673,&quot;3&quot;:{&quot;1&quot;:0},&quot;10&quot;:2,&quot;11&quot;:4,&quot;15&quot;:&quot;Calibri&quot;,&quot;16&quot;:11}">The New Jersey–based drugmaker jumped up 40 places on this year’s list—with 62.6% revenue growth—because of the additional sales that came with its $74 billion acquisition of Celgene in 2019. Sales of BMS’s anticoagulant Eliquis and its immuno-oncology drug Yervoy also showed strong growth in 2020. The company won 13 additional drug or formulation approvals in the U.S., European Union, and Japan last year; it also acquired MyoKardia, a biotech focused on cardiovascular diseases, for $13.1 billion in November 2020.

For an astounding 13th straight year, Apple claims the top spot in Fortune’s annual ranking of corporate reputation, based on a survey of almost 3,800 executives, directors, and analysts.

This year's Fortune Global 500 generated $33.3 trillion in revenues and $2.1 trillion in profits.

G500-2020-487-Bristol-Myers Squibb

The biopharmaceutical company manufactures medicines for diseases including cancer, diabetes, and psychiatric disorders.

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F500-2020-115-Bristol-Myers-Squibb

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Wal-Mart stayed on top as its sales crept closer to half-a-trillion dollars. Apple moved into the top five. And UnitedHealth Group continued its steady climb. 

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Bristol-Myers Co. and Squibb Corp. merged in 1989 to form what’s now one of the world’s largest pharmaceutical companies. Bristol-Myers Squibb develops, licenses, manufactures, and delivers biopharmaceutical products for the treatment and management of diseases including HIV/AIDS, cancer, blood disorders, and cardiovascular and fibrotic conditions.

Q1 2026

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Bristol-Myers Squibb (BMY): Company Profile, Stock Price, News, Rankings

legacy

Bristol-Myers Squibb

bristol-myers squibb

fWelcome to the Bristol Myers Squibb First Quarter 2026 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. 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 first quarter 2026 earnings call. With me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also participating in today's call is Adam Lenkowsky, our Chief Commercialization Officer, and Cristian Massacesi, 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. Reconciliation 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 2025, 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. With that, I'll hand it over to Chris.

Thanks, Chuck. Welcome and thank you for joining our first quarter earnings call. We delivered a solid Q1 and continue to improve our say-do ratio with disciplined execution across the business as we continue to best position the company for long-term sustainable growth. Our strategy remains grounded in three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio, and maintaining disciplined, shareholder-friendly capital allocation. We saw progress across all three in the quarter. Let me start by highlighting our performance on slide four. We started off the  year with solid results across our key marketed products. In the quarter, growth portfolio sales were up 9% year-over-year, with contributions from a broad range of assets, including Reblozyl, Breyanzi, Camzyos, Opdualag, Qvantig and Cobenfy.

These are differentiated, durable assets that treat serious diseases and remain early in their life cycles. They continue to strengthen our foundation for long-term growth. Overall, our growth portfolio performed in line with our expectations for this quarter. Outside of the growth portfolio, Eliquis performed well and grew in line with the range we provided on our Q4 call. David will provide more details on the financials shortly. Turning to our recent regulatory and clinical milestones. In Q1, we made progress advancing our broad and diversified pipeline. Regarding our CELMoDs, iberdomide and mezigdomide, our iberdomide filing for relapsed or refractory multiple myeloma was accepted by the FDA with breakthrough therapy designation and priority review with a PDUFA date of August 17th. This is an important step for our protein degradation platform, potentially enabling us to bring the first CELMoD to market.

For mezigdomide, we reported positive phase III interim data from the SUCCESSOR-2 study, demonstrating a meaningful improvement in progression-free survival in patients with relapsed or refractory multiple myeloma. This marks the second positive pivotal readout from our oral CELMoD program and further strengthens our conviction in the platform. We will also present the full data at ASCO and are actively planning regulatory submissions based upon the data. For our ADC iza-bren, we shared positive phase III interim top-line results in patients with previously treated triple-negative breast cancer based on a study conducted in China. We will present these exciting data along with the positive phase III China study results for iza-bren in previously treated esophageal squamous cell carcinoma at ASCO. At the same time, we continue to broaden the reach of our end market portfolio through lifecycle expansion.

We received approvals for Sotyktu in psoriatic arthritis and Opdivo for two new classical Hodgkin lymphoma indications. We also reported positive phase IV switch data for Cobenfy, positive phase III data for Camzyos in adolescents with obstructive HCM, and positive phase II data for Reblozyl in Alpha Thalassemia. Stepping back, these updates reflect the diversity and breadth of our pipeline, both in terms of therapeutic areas and modalities, as well as continued execution across the business. Moving to slide five. As we've said, the latter part of 2026 is shaping up to include an increasing cadence of pivotal readouts that are expected to further define and de-risk our long-term growth profile. Among the phase III readouts expected late in the year are milvexian in atrial fibrillation and secondary stroke prevention, Cobenfy in Alzheimer's psychosis, admilparant in IPF, and iberdomide PFS data.

We anticipate these readouts will help us further diversify and broaden our portfolio and are part of our efforts to deliver more than 10 new medicines and 30 meaningful lifecycle management opportunities by the end of the decade. Turning to slide six. Central to delivering on these opportunities and enabling sustained long-term growth are our efforts to drive top-tier R&D productivity. In our development organization, we continue to improve execution across drug development by upgrading talent, streamlining decision-making, and instituting tighter management of core clinical activities. We are also focused on enhancing the quality and depth of our early to midstage pipeline. Underpinning these efforts are investments we are making in core R&D infrastructure, including broadening the use of AI tools together with laboratory automation and people trained in the right ways of working.

In research and early development, target selection and molecule design can have an outsized impact on long-term value. We've set a target to reach lead molecule identification approximately 50% faster while applying greater rigor so that only the most differentiated molecules advance. In late development, we're using AI to streamline clinical operations, compress development timelines, and enhance quality oversight. Over time, we expect these efforts to deliver a 30% reduction in cycle times versus just a few years ago. Among others, we have ongoing partnerships with Faro, enabling us to design trials more efficiently and Evinova's Cost Optimizer tool. These ongoing efforts across R&D are top priorities for 2026. The organization's continued focus on financial discipline enables us to make these and other important investments.

We remain on track to deliver the remainder of our $2 billion in cost savings from our strategic productivity initiative by the end of 2027. With respect to capital allocation, business development remains an important focus. As always, we will continue to index on opportunities where we add strategic value and where we can deliver attractive returns. As our post-LOE growth profile becomes clearer, we'll naturally place greater emphasis on expanding our early and midstage portfolio to support growth into the 2030s. In summary, based on our performance, we see the business currently tracking towards the upper end of our guidance ranges. Looking forward, we have continued momentum in our growth portfolio, broad potential in our pipeline, and the ability to invest in our business while becoming more focused and efficient in how we operate. With that, I'll turn it over to David.

Thank you, Chris, and good morning, everyone. Our performance in 2026 is off to a strong start, as highlighted by our first quarter results. We delivered solid R&D, commercial, and financial performance while continuing to manage our cost structure. Our persistent focus on execution has further strengthened our foundation as we position the company for long-term sustainable growth. I will begin with a review of our first quarter results and then discuss our financial outlook for the remainder of the year. Starting with slide eight, total revenue in the first quarter was up 1% year-over-year at approximately $11.5 billion. Our growth portfolio continued to perform well, with global revenue increasing 9% to $6.2 billion.

As Chris mentioned, several products that are still early in their life cycles are driving growth as we intentionally expand our business across a wider range of key assets. Within the legacy portfolio, we saw solid growth from Eliquis, which was offset by the continued impact of increased generic entry across several other brands. All in, we are very pleased with our results in the quarter as we build upon our objective to reshape and redefine BMS as one of the fastest-growing pharmaceutical companies into the next decade. Turning to product performance on slide nine, starting with oncology. Opdivo revenue decreased 8% to approximately $2.1 billion, with most of this decline coming from the U.S. This is primarily driven by an Opdivo inventory drawdown at the wholesaler level, where inventories are at the low end of the typical range.

We continue to monitor whether these levels will normalize over the balance of the year. We saw continued conversion to Qvantig, where the launch continues to progress well with revenues of $163 million. With Opdualag, we delivered another quarter of strong double-digit growth driven by demand globally, where it remains a standard of care in first-line melanoma. Turning to slide 10, Reblozyl delivered 15% growth, with performance continuing to reflect solid uptake across first and second-line MDS-associated anemia. In cell therapy, Breyanzi's first-quarter growth of 53% reflects its best-in-class profile and continued strong demand across its approved indications in both the U.S. and international markets. We remain encouraged by Breyanzi's continued momentum and growth prospects. Moving to cardiovascular and immunology on slide 11, Eliquis revenue was approximately $4.1 billion in the quarter, an increase of 13%.

We continued to see strong demand, given our U.S. price reduction that took effect at the beginning of the year, we also saw some wholesaler inventory build in the first quarter. We anticipate this build to reverse in the second quarter. Turning to Camzyos, revenue in the first quarter nearly doubled to $314 million, benefiting from continued demand growth globally. Moving to immunology, global revenue of Sotyktu grew 20%. The recent approval in psoriatic arthritis represents a continued presence in rheumatology while we await our phase III readouts in lupus and Sjögren's disease. I will wrap up our product performance on slide 12 with neuroscience, where Cobenfy revenue in the first quarter was $56 million, representing continued steady growth. Let's move to the P&L on slide 13.

As expected, gross margin declined 280 basis points in the first quarter to 70.3%, which was primarily driven by product mix. Excluding in-process R&D, operating expenses for the first quarter were $3.9 billion, slightly above the same period last year. As compared to a year ago, the incremental investment related to Pumitamig, Qvantig, and Cobenfy was largely offset by savings from our strategic productivity initiative. This continues to provide additional flexibility to invest behind these growth-oriented opportunities. Our effective tax rate in the quarter was 18.3%, reflecting jurisdictional earnings mix. Overall, diluted earnings per share was $1.58 for the quarter, which includes a net charge of $0.03 a share related to in-process R&D and licensing income. Turning to the balance sheet and capital allocation highlights on slide 14.

Our financial position remains strong with approximately $11 billion in cash equivalents and marketable securities as of March 31st. In the first quarter, we generated approximately $1.1 billion in operating cash flow. This quarter's cash flow reflects roughly $1.2 billion in lower net cash collections due to Eliquis list price reductions. We expect this to be more than offset later in the year through lower rebate payments. In terms of capital allocation, we continue to take strategic and a balanced approach to deploying our strong cash flows. Business development remains a priority, and we are regularly evaluating opportunities in the therapeutic areas we know best, while continuing to return cash to shareholders through our commitment to the dividend. Now moving to guidance on slide 15. We are reaffirming our financial guidance for the full year of 2026.

Based upon the first quarter results and our current projections, we see our financial performance tracking towards the upper end of our established revenue and EPS guidance ranges. We will continue to provide updates as the year progresses. In closing, our strong performance in the quarter reinforces our confidence in our ability to deliver long-term value for our patients and shareholders. To reiterate Chris's comment, our strategy remains grounded in three priorities. Focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio, and maintaining disciplined, shareholder-friendly capital allocation. With that, I'll now turn the call back over to Chuck for Q&A.

We will now begin the question-and-answer session. The first question today comes from Asad Haider with Goldman Sachs. Please go ahead.

Great. Thanks, thanks for taking the question. Just maybe just to open, just given how consequential the clinical readouts at the end of this year are going to be for the company. Cristian, just starting with you, can you just level set us on your confidence in the key programs, specifically, for Milvexian AF and the Cobenfy ADEPT trials? Just any quantitative bars for success. Related for Chris, you know, how did the timing of these readouts impact the company's BD strategy, as you think about the different outcomes that could unfold with the results of each of these readouts? Where do you see opportunity as you scan the landscape ahead of these readouts? Any framing on potential size of the BD aperture would be helpful. Thank you.

Thanks for the question, Asad. Cristian, you want to start, and then I'll take the BD question.

Thank you. Thank you, Asad, for the question. Let me start with the fact that we have a very data-rich 2026, and even probably more 2027. Let me start with what we already achieved. Because in IM, I think, we had a positive MRD with iberdomide in EXCALIBER in 2025, and we are expecting the PFS later this year. You know, as Chris mentioned in his opening remarks, the PDUFA date for this filing is August 17th. We got a breakthrough designation, priority review, it's progressing at pace. We achieved the mezigdomide this year with SUCCESSOR-2 oral presentation at ASCO. Really looking forward to show you guys the data.

In IM, we will have a readout also with our Arlo-cel. That is a GPRC5D CAR T that is happening later this year. Moving cardiovascular, milvexian, as you were mentioning, are important readout. Both AFib and SSP continue to be expected by the end of the year. We are recruiting the events as an event-driven. Of course, we remain blinded. We are recruiting the events as planned. We have the DMC that regularly is reviewing the data. Even in the most recent meeting, they recommend to continue the studies as planned. BMS will be the only Factor XI company with Factor XI inhibitor in AFib.

Of course, with the presence also in SSP, this can allow us to continue to lead in the thrombotic space. Confidence remain absolutely unchanged for milvexian in this space. In neuroscience, we continue to expect the ADP studies, ADEPT-1, ADEPT-2, and ADEPT-4 by readouts by the end of the year. We are managing the studies and moving the studies more or less at the same with the same timelines, so they are lining up quite nicely. We need the two studies probably for an approval. This is the base case, but for a filing, but we will see how the evolution in this space is happening.

The confidence remain unchanged also for Cobenfy. Study designs, trial conduction, is now completely under control. Of course, the reason to believe in Cobenfy in this space are very clear. Prior data, the data that we have seen in schizophrenia and of course, the open label in ADEPT-1, where patient before being randomized received Cobenfy for 12 weeks, give us confidence in potentially bringing this drug in patient with Alzheimer's disease psychosis. Last but not least, to me, critical readout this year is admilparant in immunology in IPF and PPF. You know, this is a novel mechanism, LPA1. This is an inhibitor that can bring a novel mechanism to patient with this very very difficult to treat disease.

It's a first in class asset with a very differentiated profile, not only on efficacy side, but also on the safety side. IPF is guided by the end of the year. PPF will be just a few months later, probably beginning 2027. Very solid phase II data. I'm very pleased on the execution of the phase III programs. This is another important therapeutic option. As Chris mentioned, there is much more this year, next year. I have to say, it's an exciting time to be at BMS.

Thanks, Cristian. Asad, just on your BD question. Look, BD continues to be a top capital allocation priority for us. It's not impacted by the end of year readouts. We have a very strong late stage pipeline. We certainly don't need to chase deals. As we've said consistently, if there are opportunities that make sense for us to enhance near term growth, we have the financial flexibility to be in the mix. At the same time, we're building for the long term, and we're going to continue to add to our early and mid-stage pipeline as well. Of course, given the size of those deals, we can certainly do both.

Irrespective of phase of development, though, the opportunities we're looking for in areas we know well scientifically where we can add clinical and commercial value and ultimately, we can deliver value to patients and to our shareholders. We're size agnostic as we've been, and we certainly have the financial horsepower to go after multiple size deals.

Thanks, Chris. Let's take our next question, please, operator.

The next question comes from Geoff Meacham with Citi. Please go ahead.

Great. Morning, everyone. Thanks for the question. Cristian, on Pumitamig, I wanted to check on the cadence of data in, say, the next six to 12 months. Would you wait for more mature data on TSS before you really, you know, expand the number of trials, or are you ready to go right now? Real quick for Adam, just to talk through the Qvantig, you know, dynamics versus Opdivo and, you know, where you're seeing the biggest demand. Thanks.

Thank you, Geoff, for the question on Pumitamig. Let me start with ASCO. ASCO will be an important meeting this year for PD-1/VEGF inhibitors. You know, there are some competitor data in plenary that of course, increase the confidence in the class. We are presenting as a normal, our phase II data in non-small cell lung cancer in front line as a global data set after the China data we presented previously in other indications. In few days, the abstract will be released. Our strategy with Pumitamig is replace and expand. We want to replace PD-1, PD-L1 inhibitors, and we want to expand beyond that. We announce and we deliver seven pivotal studies across indications. All of them are ongoing, and all of them are recruiting actively.

What is very important in my view is also what we are doing beyond the first wave of trials. The confidence in my view, is becoming more and more tangible in terms of level of activity, a combinability that you have with PD-1/VEGF, PD-L1/VEGF inhibitors by specifics. In my view, this is potentially translatable across indications. Now, the next step, at least in our strategy, is novel combinations. You know, BMS has a very rich oncology portfolio. BioNTech has also an important portfolio of oncology assets. What we are doing, we are combining now. We started the combination of Pumitamig with these other drugs that represent an enabler for novel regimens, also using some combination with external partners.

On our internal side, we started the combination with our iza-bren ADC, which is an EGFR-HER3 ADC. You will see data, as Chris was mentioning, at ASCO in esophageal, in triple negative. It's a very active ADC, and I think with Pumitamig, it can represent a very powerful regimen. We started a combination with our PRMT5 inhibitor, our navlimetostat, a very dual type drug. In, in summary, I have to say that the partnership with BioNTech is moving very well because we are progressing the development of this drug with speed. We think we are very well positioned to make this drug as a potential new backbone in immune oncology and generating the next regimens as very powerful cancer patients across indications. Adam?

Yep. Geoff, thanks for the question. As it relates to Qvantig, we're pleased with the Qvantig launch performance. Our teams are executing well, and we're seeing use across multiple tumor types. We're seeing uptake in our monotherapy indications as well as in combination treatment, so in RCC, in gastric cancer, and in melanoma. We're continuing to hear positive feedback from community oncologists that Qvantig improves practice efficiency with a 3-minute in-office injection, and that patients prefer Qvantig when offered the opportunity versus the IV formulation. We've now delivered over 10% conversion from IV to Qvantig in the U.S. in just over a year on the market, and we're tracking well against our expectations. We remain confident in our expectation that physicians will convert approximately 30%-40% of IV business in the next two years.

Great. Can we move to our next question please, operator?

The next question comes from Alexandria Hammond with Wolfe Research. Please go ahead.

Hey, guys. Thanks for taking the question. On milvexian, given the size and breadth of the Librexia program, seems like there's probably a rich set of outcomes between a clean win and miss. Can you help us think through how you'd approach a subgroup analysis, particularly for patients where the risk-reward calculus might be more favorable for Factor XI? To the extent that the top line doesn't meet that primary endpoint cleanly, is there a path where a specific patient population still supports a meaningful commercial opportunity? Thank you.

I'll have Cristian take that, and then Adam, you can add any color commentary as you need to.

I mean, Alex, let me start that to tell that we continue to be on track by the end of the year with both AFib and SSP. You know, these trials are remained driven. We remain blinded. As said, the DMC continues the oversight to the both studies. We are at a point in which this give us confidence that we are progressing on the right way with both efficacy and safety. Everything is continuing as planned. You know, in AFib, the study will test non-inferiority versus apixaban. Then we will have a superiority testing for bleedings.

Based on what we have seen in other trials recently and based on the expectation and how we size and power the study, I think, we are very much on track with both the endpoints to show non-inferiority and superiority in bleedings. Adam?

Yeah. Alex, as it relates to commercial opportunity, milvexian represents a significant opportunity commercially. There's a need for a medicine with low bleeding risk both in AFib and in SSP, and we think there's a significant advantage to having both indications. We would expect broad adoption. As we talked about previously, you know, fear of bleeding continues to be the main reason why physicians hold back from utilizing Factor Xa's in more patients. Despite the highly effective DOACs like Eliquis, roughly 40% of patients who should be anticoagulated are either untreated, so you're underdosed or they discontinue treatment, and that's driven largely by concerns around bleeding risk. This leaves a meaningful unmet need across a substantial number of patients. As a reminder, this study in AFib was designed to demonstrate a superior bleeding profile compared to Eliquis with comparable efficacy.

We believe this profile is gonna drive significant demand and will be important for both patients and providers. As Cristian said, we're looking forward to the data readout at the end of this year, and we think this has true blockbuster potential.

Great. Let's move to the next question, please.

The next question comes from Chris Schott with JPMorgan. Please go ahead.

Great. Thanks so much for the questions. Just two for me. Maybe first, can you just talk about Camzyos dynamics post your competitor approval? Just what are you seeing in the market, and just how are you thinking about that evolving? The second one for me was coming back to the CELMoDs. That was, you know, kind of some of this initial clinical data is read out. Can you just elaborate a little bit more the role in the market you see for those products based on these initial data sets, and how much of the, your excitement here is based more on the future readouts versus what we're seeing initially here? Thanks so much.

Thanks for the question, Chris. Adam, I think you can take both.

Thanks, Chris. Camzyos continues to have very good momentum. Our commercial teams are executing very well in the field. We are seeing continued strong new patient starts coupled with high persistency rates. Physician and patient feedback are very favorable, and physicians consistently cite the significant and rapid improvement in symptoms, and we're seeing very low drop-off rates. In fact, you know, we are approaching 25,000 patients now prescribed Camzyos in the U.S., with thousands more prescribed internationally. As far as, you know, what we're seeing in the field, you know, we've been planning for competition for some time. HCP has continued to reinforce that they see, you know, little differentiation. It's still early. Some physicians have started one or two patients on the competition and, you know, they are still operating, operationalizing their own REMS program.

We also hear consistently that the Camzyos REMS process is very clear, and the infrastructure and workflow that have been established now for four years, you know, are, you know, very clear. Thus, CLs have shared they'll use the Camzyos dosing and echo regimen at four weeks. We see this as a positive. Why is that? Because roughly 90% of patients on Camzyos are on the 5 mg starting dose. It's simply, you know, one dose titration to 10 mg. So, it's 5 or 10 representing 90% of our business, which is effective for the majority of patients. Camzyos patients feel better in a matter of weeks. Where we see from the competition requires multiple titration steps to reach an effective dose.

You know, our teams were well prepared for the launch of aficamten, and we remain confident that we'll be the leader in the space longer term. As it relates to, you know, to iberdomide, I think, you know, we're really excited about the launch of iber. I know that Chris and Cristian have talked about this. I think there are a few areas that, you know, I could point to. Number one, you know, with iberdomide, and this is an area that we know very, very well in multiple myeloma.

We see that, you know, for multiple myeloma, it's a highly competitive, it's a fragmented market, but there remains a need for more effective and safe options that can address the majority of patients, particularly those patients who are treated in the community setting, and that's 70%-80% of patients. When we hear from physicians, they're excited about oral, low-burdensome regimens that can provide a better experience for their patients. We're confident that iberdomide will provide a balance of high potency, manageable toxicity, combinability with daratumumab, with the convenience of an oral treatment that amplifies the efficacy of image-based regimens. Our goal is to make both iberdomide and mezigdomide foundational in multiple myeloma, replacing Revlimid and Pomalyst in second line over time in the community. Longer term, serving as partners for T cell redirecting therapies and cell therapy.

We know the work that we need to do to establish both iber and mezi in the market, and we're very excited to bring both of these important medicines to patients because we believe this is a real attractive commercial opportunity.

Adam, allow me to step in. Chris, I wanna use the opportunity you mentioned in the question on Camzyos, because I received, we received often the question about the non-obstructive HCM plans. I think first of all, let me start that the level of benefit expecting in a non-obstructive is different than an obstructive, because of the heterogeneity of patients and diseases is much higher. That said, we have learned a lot from ODYSSEY-HCM. We know better where the patients and which diseases they are affected by that can benefit most from a myosin inhibitor like Camzyos.

I wanna announce that we are planning now to run a new, more focused study in non-obstructive HCM, of course, the detail of it will be highlighted in clinicaltrials.gov. We are progressing this work.

The next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead.

Hi, guys. Thank you so much for taking my question. Another one for Cristian. You really inherited the design and kind of the milvexian trials. Can you walk me through the aspects of the trial design, patient selection that, you know, increased your confidence in a potentially successful readout later this year?

Thank you, Evan, for the question. I think your question is referring to AFib specifically, I imagine, because.

Yeah. In AFib, let me tell you that, first of all, the data are solidly based on a phase II studies that we run in total knee replacement. That is a very good surrogate for antithrombotic drugs. We learned a lot from Eliquis in that space, and we know the predictivity value of that kind of population for antithrombotic agents. I think the very elegant, the refined work that has been done with milvexian was in selecting the dose for AFib. That was in that trial, we tested multiple dose levels, and ultimately we landed with 100 milligram twice a day. That is a much higher dose, for instance, that we are using in SSP.

It's a dose that gave us the confidence based all the work that has been done, the modeling and the work and then the phase II part, give us confidence to have at least the same level of efficacy that what we expected with apixaban, preserving of course the bleeding value. Going specifically to your question, the design of the study is to be able to show a non-inferiority versus apixaban in an end-to-end comparison in a very well sized study. We recruited 20,500 patients, very well powered for an inferiority margins. We disclose these margins. Of course, they go from 0.8 to 1.3.

We will then, when an inferiority will be met, test the superiority for bleedings. We test with split alpha for measured bleeding and no measured clinical relevant bleedings. I wanna link what Adam was telling. This is a measured problem in the clinical setting, being able to show that the drug provide benefit in terms of decreasing the bleedings will be very important in the marketplace. As said, the study is fully powered, well-designed, and pick, in my view, the right dose to being able to show what the study predefined criteria should meet.

Thanks, Cristian. Thanks, Evan, for the question.

Let's move to our next question, please, operator.

The next question comes from Michael Yee with UBS. Please go ahead.

Thank you. Following up on the design of the milvexian study. If you take a look at the recent AFib results, you can see that the stroke rates are quite historically a lot lower than they were back in the original days of Eliquis. Just thinking about whether you've taken that into consideration and to what extent you think that impacts the study design and whether you think that there's any chance that the study results will ultimately end up in 2027, which could end up being more positive for you than in 2026. Thank you.

Okay. Thank you, Michael, for the question. You know, we cannot disclose baseline characteristics and which kind of events we are recruiting. By the way, we are blind, of course, to the study. What I can tell you again is that the AFib study, Librexia study, has the right sample size and of course, has a predefined number of events. We are recruiting the events as expected. The events predefined number is for efficacy and of course for safety. We are on track by year-end. It's event-driven. We are in April. We will see later in the year if this event rate will change or not. For the moment, we are on track for any year-end readout.

Great. Thank you, Cristian. Next question please, operator.

The next question comes from Akash Tewari with Jefferies. Please go ahead.

Thanks so much. For your Cobenfy Alzheimer's psychosis studies, you have several trials, but I know ADEPT-4 requires patients to have a confirmed Alzheimer's diagnosis using both imaging and blood-based biomarkers. Can you talk about why you added that criteria for the study? Was it based on any issues you saw with the ADEPT-2 trial conduct? Just on CELMoDs, can you talk about your confidence on the SUCCESSOR-1 study, which goes head to head against Pomalyst, showing a clinically meaningful effect size based on the results you saw in SUCCESSOR-2? Thank you.

Thank you, Akash. The Cobenfy ADEPT-4 decision to go into a biomarker selected population was based in a try to decrease the heterogeneity in the patient population. As you know, ADEPT-2 was a study that was already ongoing in the moment we acquired Cobenfy. We wanted to have a more predefined patient population to be recruited into an Alzheimer's disease psychosis setting. This is why we took this approach of biomarker positivity. That can be done through plasma or radiologically.

I think of course, this is increase the confidence that the right patients are treated in the trial, even if increase a little bit the operational, the operational challenges because of course, we need a predefined number of patients biomarker positive to run. The screening failures are a little bit higher. This doesn't take out any confidence of the potential benefit you can see also maybe in a trial like ADEPT-2, where we do not have a biomarker positive study because ultimately you treat symptoms, but give more confidence that you have Alzheimer patients. This is the main reason. We are not the only one doing this, taking this approach in the space.

Going back to your second question on CELMoDs, I think SUCCESSOR-2 was a very good news, not only because it and as you mentioned, SUCCESSOR-2 is an add-on study on top of Kd, but because it came earlier than expected. We hit an interim PFS. You will see the data at ASCO, but you already know that when you hit an interim PFS, it means that you hit a bar that is higher according to what the study was designed for. This is answering your question on SUCCESSOR-1. We believe mezigdomide is a very potent CELMoD, is more potent than iberdomide, for instance, is a drug that can be very well combined with the standard of care regimens that we see.

A little bit less with anti-CD38. This is why iberdomide is doing that job. I believe that the level of efficacy we have seen and the design of the study let us believe that this drug can be better than Revlimid and pomalidomide. The confidence of SUCCESSOR-1 is high and of course, is higher bar because it's not an add-on, it's a replacement strategy, but I think the PFS is high.

Thanks, Cristian. Let me just also say that I'm glad to hear so many questions on CELMoDs. The CELMoD program we're quite excited about. You're going to see exciting data at ASCO on iberdomide and mezigdomide. We shouldn't forget you'll also see data on golcadomide, which continues in my view to be a sleeper in the program just because of the high quality data that we've seen thus far. You'll see more of that data at ASCO. Of course, behind this, we've got additional degraders, BCL6 LDD, AR LDD. This program and this platform is quite deep, and it's nice to see these data maturing as they are across each and every one of these programs. It's exciting to see. Stay tuned for that at ASCO and beyond.

Thanks, Chris. Let's take our next question, please.

The next question comes from Louise Chen with Scotiabank. Please go ahead.

Hi. Thanks for taking my questions. I wanted to ask you, in addition to your ADEPT study for Cobenfy, I know you have several additional potential indications for Cobenfy. Which of those additional indications are you most excited by? Secondly, you have a lot of different modalities in your cell therapy franchise and pipeline. How do you see these all coming together to give Bristol a more comprehensive hold on the market? Thank you.

Cristian, and then Adam, you can provide color commentary.

ADP, because we believe that this is a huge medical need, and we believe that Cobenfy can bring benefit based on what we have seen in schizophrenia. You know, we are focusing our strategy in psychosis, specifically assessing hallucination delusions. This is something that we have seen a patient really having an improvement in schizophrenia. We wanted to have multiple shots on goal. This is why we have ADEPT-2 and ADEPT-4 that are similar studies. With the difference one is biomarker selected population, the other one not. We have ADEPT-1 that is more a study that will assess how Cobenfy will avoid relapsing. We also design ADEPT-5.

We are now four shots on goal in this program because the base case I was mentioning before is having at least two positive. Things are changing, maybe. We believe this is an important, an important setting. Cobenfy can bring benefit to patients. We wanna really have a multiple shots on goal. When thinking the other indication, bipolar disorder is the next one in line because we expecting results in 2027. We are testing Cobenfy specifically in mania, on the, in the context of bipolar disorders. You know, if you think this is a very similar in terms of the productive symptoms that we see in AD psychosis. We have AD agitation.

AD agitation is very related to psychosis because this is one symptom, so that we have seen Cobenfy already providing benefit. The confidence is high also for this. Agitation is coming in 2028, like cognition, AD cognition. Cognition is a probably different mechanism. Psychosis is probably mediated by muscarinic receptor 4, cognition probably by muscarinic receptor 1, but Cobenfy is working on both. This is where the confidence stay. I would say the Cobenfy we believe can bring a benefit in controlling these kind of symptoms at, in Alzheimer, in the bipolar patients, and is an anchor asset for our portfolio in neuroscience. We are building.

I really would like you to start to see how we are building our portfolio in Alzheimer's disease with a phase II asset, a multiple phase I assets that show the commitment that BMS has for this disease, because we wanna play in this in this disease.

Yeah, just to add, Cristian, you did a great job covering, you know, much of our lifecycle management program. From a commercialization standpoint, I would say, you know, stepping back, there are roughly 7 million patients diagnosed with Alzheimer's disease. Roughly 30%-50% have psychosis, and that's hallucinations and delusions. The vast majority have cognitive impairment. This presents a real significant unmet need where there are no approved treatments today. You know, we know that antipsychotics have significant safety limitations. They have movement disorders. They carry box warnings that are specific to elderly patients with dementia. They're often treated and used inappropriately rather than treating the underlying psychiatric diseases. You know, they leave patients with cognitive impairment, falls and fractures. These are all really serious issues in long-term care facilities.

We believe that Cobenfy has potential to play a very important role in treating a number of Alzheimer's diseases. Safety becomes increasingly important in an elderly population where Cobenfy is not associated with EPS sedation, doesn't carry a box warning. In those two areas, ADP and Alzheimer's disease cognition, Cobenfy would be the first and only product approved in those spaces.

Thank you, Adam. Louise, let me go back to your second question on cell therapy. You know, I could discuss about cell therapy strategy in hematology or in autoimmune disease. I wanna focus on autoimmune disease because probably is newer and I think is more important that we explain the strategy that we wanna put in place on the development, maybe in the commercial side. You know, I believe BMS has a very powerful platform in this space, and with one aim, a reset the immune system. To reset the immune system, this is the strategy that we wanna take, we decided to have a multimodal approach. This is why we have an autologous, an allogeneic, and an in vivo platform.

I have to say this set us apart compare many other players in this space. If you think of these products, this can be transformative for patient with autoimmune disease, because if you can eradicate B-cells, you can provide benefit to patient with a severe or moderate state of the disease. The vision can be to use this one time treatment before the patients start to have the organs damaged by the autoimmune diseases. The most advanced program is Zola-cel, our autologous CAR T, we have two ongoing pivotal studies, one in lupus and one in scleroderma. We have a multiple other indication ongoing, and we see a level of activity that is unprecedented.

We have in clinic now an allogenic CAR T that of course can represent a more accessible and scalable approach because from one donor you can manufacturing 100 cells. This can broaden up the access. The real transformative thing can be in vivo. We acquire Orbital, an mRNA in vivo platform, where you have the patients that are producing, manufacturing the cells in cell versus self. This is really can be transformative because it can really broaden up and give scalability in such a broad space like autoimmune disease. I hope I addressed the strategic. We wanna be a player. We wanna lead in this space. I think we are very well set to doing that.

Thanks, Cristian and Adam. Let's move to our next question, please.

The next question comes from Terence Flynn with Morgan Stanley. Please go ahead.

Bristol-Myers Squibb (BMY) Q1 2026 Earnings Call Transcript

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