The companies on the Global 500 employ 70.2 million people, and their revenue represents more than one-third of the world’s GDP.

Fortune Global 500

With a combined revenue of $21 trillion and $2.1 trillion in profits, the 2026 Fortune 500 is the definitive list of America's largest companies.

Fortune 500

The 300 companies on this year’s list brought in over $12.5 trillion in revenue for the latest 12 months, with the median revenue figure at $24 billion.

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2025 Best Workplaces Europe_Bristol-Myers-Squibb-photo-2

Bristol-Myers Squibb ranks 34 on this year’s Fortune 100 Best Companies to Work For – Europe list.

Fortune 100 Best Companies To Work For – Europe

The corporations on our annual list of the world's 500 largest companies combined to generate $41.7 trillion in revenue over the past year.

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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.

Fortune Sector Leaders: Health Care

The Fortune 500, in its 70th year in 2024, ranks the biggest U.S. companies by revenue.

The 200 companies on this list are transforming industries from the inside out.

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The corporations on our annual list of the world’s largest companies delivered a record $41 trillion in aggregate revenues.

Fortune collaborated with the Diligent Institute to rank the most innovative boards of directors among S&P 500.

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>

Just as it dominates our economy, Big Tech now dominates Fortune’s annual ranking of corporate reputation.

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

This year’s Fortune 500 marks the 68th running of the list.

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.

After a year in which humanity leaned more heavily than ever on tech giants, see which companies topped Fortune's ranking of corporate reputation.

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.

This year's Fortune 500 marks the 66th running of the list.

F500-2020-115-Bristol-Myers-Squibb

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This year's Fortune 500 marks the 65th running of the list.

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Business insiders have spoken: Asked which companies they most admire, more than 4,100 executives, directors, and analysts chose these top 50 All-Stars.

This year's Fortune 500 marks the 61st running of the list. Wal-Mart claims the top spot again. See who made the list.

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.

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

legacy

Bristol-Myers Squibb

bristol-myers squibb

Welcome to the Bristol Myers Squibb second 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. 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 second 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. 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 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. Good morning, everyone, and thank you for joining our Q2 2026 earnings call. We delivered another excellent quarter driven by disciplined execution across the business. Our progress towards transitioning the portfolio to fuel durable long-term growth is reflected in our growth portfolio's strong Q2 performance. At the same time, we're delivering strong performance from our existing business. We're also advancing a broad and differentiated pipeline while maintaining financial flexibility to invest in the highest value opportunities for patients and shareholders. Together, these efforts continue to strengthen the foundation we're building and increase our confidence in our ability to grow the company as we exit the decade. Let me walk you through some of the highlights of our performance, beginning with our Q2 results on Slide four. Our growth portfolio continued its strong performance with sales up 14%.

Key assets including REBLOZYL, BREYANZI, CAMZYOS, Opdivo, and Qvantig continued to perform well, with 10 products in our overall portfolio achieving double-digit growth. This performance demonstrates both the value creation of our portfolio and the continued execution of our commercial organization. Based on the strength of our results, we are increasing our full year 2026 revenue and adjusted EPS guidance. David will provide additional details shortly. Building on our end-market performance, our pipeline of differentiated assets is an important driver of our long-term growth, and we're making significant progress there as well. We had an exciting ASCO in June, where we shared data that reinforces the breadth of innovation across our leading oncology franchise. To highlight a few examples, in hematology, we presented positive phase III data from the mezigdomide SUCCESSOR-2 study evaluating mezigdomide for patients with relapse or refractory multiple myeloma.

The study showed a statistically significant and clinically meaningful improvement in progression-free survival. This further strengthens our confidence in the CELMoD class and its potential to drive the advancement of future myeloma treatment. In solid tumors, we saw encouraging phase III data from two iza-bren studies supporting our strategy of building differentiated ADC capabilities across multiple difficult-to-treat solid tumors. We are also initiating our fourth global phase III study in first-line EGFR mutant non-small cell lung cancer. For pemetrexed, we shared encouraging early phase II global data in combination with chemotherapy for first-line non-small cell lung cancer. In terms of our expanding development program, we are initiating a new phase II novel study combining pemetrexed with imzokitug, our CCR8 antibody. These programs reinforce the power of our innovation engine and support our strategy of combining different modalities to deliver transformational medicines and improve patient outcomes.

Turning now to our near-term pipeline milestones we anticipate during the remainder of 2026 on slide five. We've talked about our ambition to translate a data-rich pipeline into durable long-term growth drivers, and we continue to expect pivotal readouts across our therapeutic areas by the end of this year. These near-term readouts represent compelling opportunities, including admilparant, a potential first-in-class medicine that could redefine the standard of care in pulmonary fibrosis, arlo-cel in relapse or refractory multiple myeloma, iberdomide progression-free survival data, milvexian in secondary stroke prevention, RYZ101 in GEP-NETs, and Sotyktu in lupus, a disease affecting millions of patients with very limited treatment options. Each of these pipeline opportunities carries the potential to redefine treatment standards, addressing large underserved patient populations and helping to accelerate our long-term growth trajectory. Together, they represent multibillion-dollar peak sales potential and reflect the full depth and breadth of what we're building.

For milvexian, we now expect the atrial fibrillation study to read out in the first quarter of 2027. This is an event-driven study, and the updated timing from late 2026 reflects the pace of events. As a reminder, the study is being monitored by an independent data monitoring committee, which continues to endorse the study. With the passage of time, as the study progresses, we are increasingly encouraged about milvexian's potential and look forward to seeing the results of this important study. With respect to the COBENFY development program in Alzheimer's psychosis, based on the pace of enrollment in the ADEPT-2 and ADEPT-4 studies and relapse events accruing more slowly than projected in ADEPT-1, we now anticipate top-line data readouts from the ADEPT program to begin in early 2027 and be spread across the year with the potential interim analysis for ADEPT-1 later this year.

While we await those readouts, we look forward to sharing safety and efficacy data later this year from the open label lead-in portion of ADEPT-1, as well as data from ADEPT-3, which is the open label rollover study for patients who have already completed the ADEPT-1, -2, and -4 studies. These data reinforce our continued confidence in the potential for this medicine in Alzheimer's psychosis. Finally, our phase III BALSAM-1 and -2 studies evaluating COBENFY in bipolar I disorder continue to enroll well, and we anticipate reading out in the first half of 2027. In addition to these upcoming data readouts, we're also beginning to see the next stage of our pipeline strategy come into focus as recent clinical progress translates into regulatory decisions.

We are awaiting the August 17th PDUFA date for iberdomide and are ready for the launch of this important medicine, which has the potential to be the first commercialized CELMoD. This would represent a brand-new class of treatment for myeloma, a historically difficult-to-treat illness with a patient population that could significantly benefit from new innovative options. We're pleased that the FDA accepted our NDA for mezigdomide with a PDUFA date of May 13th, 2027. Together, iberdomide and mezigdomide continue to reinforce our confidence in the long-term potential of our protein degradation platform. The FDA also recently accepted our supplemental NDA for CAMZYOS in adolescents with obstructive hypertrophic cardiomyopathy and assigned a September 30th PDUFA date.

At the same time, we continue to actively plan our previously announced phase III study evaluating CAMZYOS in patients with non-obstructive hypertrophic cardiomyopathy and expect to initiate the study by the end of the year. I want to step back for a moment and take stock of where we are and why I'm energized by what's to come. Our growth portfolio is delivering today, our differentiated pipeline is on the verge of multiple pivotal readouts with the potential to introduce more than 10 new medicines by the end of the decade, including iberdomide and mezigdomide, both of which have upcoming PDUFA dates. In addition, we also anticipate over 30 meaningful lifecycle management opportunities during that same period. Our priorities are clear: continue executing with discipline and translate differentiated science into transformational medicines for patients. Turning to slide six, we continue to evolve how we operate as a company.

Over the past few years, we've made significant progress rewiring BMS into a more agile, focused, and efficient organization. This includes expanding the use of AI to help our teams move faster, execute better, and operate more effectively. Over the past several years, BMS has embedded AI across its research and enterprise operations, demand for compute has grown alongside the scale and maturity of our AI capabilities. In support of this expansion, we've recently announced partnership agreements with both Anthropic and NVIDIA. Concretely, this will help our scientists do three things: understand disease biology more deeply, design and test candidate molecules faster, and make earlier, better-informed decisions about which programs to move forward. At the same time, we remain disciplined in how we manage our resources. Our focus on productivity continues to generate meaningful savings.

When combined with our strong free cash flow generation and balance sheet, these efforts continue to fortify the company's financial foundation. Before I turn the call over to David, I'll emphasize that the strong financial foundation we've built provides us with the optionality and flexibility to continue investing in growth drivers, pursuing business development opportunities, and returning cash to shareholders. With that, David, over to you.

Thank you, Chris, good morning, everyone. We delivered another strong quarter, with results continuing to highlight the underlying strength of our growth portfolio, comprised of many products that are early in their lifecycles. Our performance is also supported by disciplined investment and growth-oriented initiatives. Results were further bolstered by ELIQUIS. Based on this first half momentum and confidence in our second half outlook, we are raising our full-year guidance for both revenue and adjusted diluted EPS. Let me begin with a review of our second quarter results. Starting with slide eight, total revenue in the second quarter increased 5% year-over-year to approximately $13 billion, with strong performance of our growth portfolio offsetting legacy portfolio decline. Growth portfolio revenue rose 14% to $7.6 billion, now representing nearly 60% of total revenue.

As Chris referenced, multiple products contributed to this growth as this portfolio continues to emerge as a broadening foundation for durable long-term growth, further supported by the broad pipeline. Within the legacy portfolio, ELIQUIS delivered demand-driven growth of 21%, which nearly offset declines from generic entry across the remainder of the legacy portfolio. Despite full generic availability in the U.S., REVLIMID revenue remains more resilient. Turning to product performance on slide nine, starting with oncology. Sotyktu continued its strong launch trajectory with revenue of $261 million and is now annualizing at over $1 billion. For OPDIVO, revenue decreased 4% to approximately $2.5 billion, primarily driven by continued conversion to OPDIVO Qvantig in the U.S. In the quarter, we saw some inventory build at the wholesale level, reversing some of the drawdown we referenced in the first quarter.

OPDUALAG delivered another quarter of strong double-digit growth, which continues to be driven by demand globally and its leading position as a standard of care in first-line melanoma in the U.S. Turning to slide ten, REBLOZYL grew 29%, reflecting solid uptake in first-line MDS-associated anemia, continued strength in the second-line setting, and further penetration in the first-line Rh-negative population. BREYANZI posted 41% growth in the second quarter, driven by its best-in-class profile and strong demand across approved indications in both the U.S. and international markets. As in prior years, we anticipate the typical summer demand patterns to moderate growth in the third quarter. Moving to cardiovascular and immunology on slide eleven. ELIQUIS revenue was approximately $4.5 billion, up 21%, driven by strong demand through continued market share gains.

As a result of the price decrease implemented at the start of the year, U.S. second-half sales are expected to benefit from the elimination of the accumulated CPI penalty in certain government channels. CAMZYOS's revenues increased 59% to $416 million, reflecting continued promotional efforts, new patient prescriber additions, and deeper penetration into the community setting. Moving to immunology. Global revenue for Sotyktu grew 23%. We are supporting the recent indication for psoriatic arthritis in adults, and we look forward to the phase III readouts in lupus later this year. I will wrap up our product performance review on slide 12 with neuroscience. COBENFY grew 81% to $63 million in revenue in the quarter, reflecting continued steady progress in the schizophrenia market. Moving to the P&L on slide 13. Gross margin in the second quarter was 71.4%, reflecting product mix.

Operating expenses for the second quarter were $4.1 billion. We continue to benefit from our strategic productivity initiative, which provides us both the ability to reduce expenses in identified areas, as well as the flexibility to invest in multiple growth-oriented opportunities. Our effective tax rate in the quarter was 16.5%, reflecting jurisdictional earnings mix. Overall, diluted earnings per share were $2.04 for the quarter. Turning to the balance sheet and capital allocation highlights on slide 14. We remain in a strong financial position, with approximately $11.5 billion in cash equivalents and marketable securities as of June 30th. In the second quarter, we generated approximately $3.4 billion in operating cash flow and paid down an additional $1.2 billion in debt. In terms of capital allocation, we maintain a strategic and 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. Moving to guidance on slide 15. We are increasing our full year 2026 financial guidance for both revenue and adjusted diluted EPS based upon our strong first half results and our current projections for the balance of the year while maintaining our projections for gross margin, other income and expense, and our tax rate. Incorporated into these revisions are projected higher ELIQUIS revenue growth of 20%-25% and a less pronounced total legacy portfolio revenue decrease now expected to be between 4% and 6%.

We have slightly increased our projected operating expenses for the year to account for accelerated pre-launch activities supporting our CELMoDs, iberdomide and mezigdomide, the expanding pomalidomide development program, and opportunities to further support the growth portfolio. To reiterate Chris's comment, our strategy remains focused on driving execution across the organization to build momentum in our growth portfolio and advance our pipeline while maintaining financial flexibility to balance investment in future growth with disciplined shareholder-friendly capital allocation. In closing, our strong performance in the quarter reinforces our confidence to deliver long-term value for our patients and shareholders. With that, I'll now turn the call back over to Chuck for Q&A.

Thanks, David. Everybody, if you could, please help us pose questions, operator, and we'll get started with the Q&A session.

We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. We ask that you please limit yourself to one question. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question today comes from Geoff Meacham with Citi. Please go ahead.

Hey, guys. Thanks for the question. Congrats on the quarter. Chris or Cristian, I guess I just wanted to talk about the ADEPT and milvexian studies going into 2027. I know they're event-driven, maybe can you talk a little bit about what this means relative to your initial assumptions? Is there something in the patient population maybe that has changed or that is perhaps different than what you guys initially assumed? Just wanted to get a little bit more context for both of those. Thank you.

Morning, Geoff. Thanks for the question. Cristian?

Good morning, Geoff. Thanks for the question. Let me start with COBENFY with ADEPT. First, let me explain the reasons for the delay. Chris highlighted in his opening remarks, let me dig into it. In ADEPT 1, we are recruiting events, psychotic relapses, and we are having now slower pace of how we are recruiting these events than predicted. This can be seen overall in a positive way.

ADEPT 1 will be the first interim analysis to read out by the end of this year or beginning of next year. In ADEPT 2 and ADEPT 4 is different because like for the rest of COBENFY program, the first priority has been to ensure the highest quality in terms of the patients we are including in the trial, the conduction of the study. If you think about it, this is one of the best ways to ensure for these trials the highest chance of success. This is very important also to support the registration. So this scrutiny in preserving quality and increasing quality impacted the enrollment phase. The second point I want to make is about where we are now. I think we have implemented now several measures to accelerate this enrollment, and I think the pace and the projections on timelines are solid.

Finally, related to your question on ADEPT program overall, there has been no change in any way in our confidence in both the underlying science, the scientific rationale, and also the study designs that we are implementing in ADEPT program. We continue to believe that COBENFY can provide a substantial benefit to patients with Alzheimer's disease and psychosis. Actually, this is the main reasons we decided to share the open label data of ADEPT 1 and the rollover ADEPT 3 data in one of the next meeting or forums later this year. Moving to milvexian, as you said, and Chris said, first of all, we remain blinded, but this shifting into first quarter 2027 of Afib timelines is, again, simply a reflection of the way, the pace we are recruiting events. It is lower than predicted.

DMC continued to oversee the study in a regular way and continue to endorse the conduction of the study. I see favorably this delay because actually give us more confidence that we are a target for both the primary endpoint, non-inferiority, and the secondary endpoint, superiority on bleedings. I remain very excited milvexian can be the first Factor XI drug to be at parity on efficacy with ELIQUIS, but beating ELIQUIS on bleedings.

Great. Thanks for the detail, Cristian. Let's take our next question, please.

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

Great. Thanks so much. Just following up on milvexian, I guess beyond just the non-inferiority primary endpoint, I think there's a debate on the street of what type of hazard ratio you need to see for this drug to get broad adoption, cannibalizing sizable pieces of ELIQUIS versus just targeting maybe an underserved segment of the AF market. Can you just help frame out what you think you'd need to see from that study for this to be a very large opportunity for Bristol versus what would be maybe more of just an incremental new product for the company, just in terms of how strong that data has to be? If I just throw a second one in really quickly. On the guidance increase, can you just talk a little bit about the drivers of the upside for the growth portfolio that's implied in the guidance?

I guess, are there any standout assets that are driving that upside? Thanks so much.

Thanks for the question, Chris. I'll ask Adam to start, then David, you can jump in on guidance.

Great. Thank you, Chris. Good morning. milvexian represents a significant commercial opportunity, and we know there is a need for a medicine that has low bleeding risk, lower than ELIQUIS, and can play across both Afib and SSP. As far as the atrial fibrillation opportunity, this is a very large market. There are approximately 10 million patients diagnosed and treated in the U.S. We know this market well. We know the customers well, and we know what it takes to compete and win. Fear of bleeding continues to be the main reason why clinicians continue to hold back from using more Factor Xa in more patients. Despite what we see today with ELIQUIS, there's still roughly 40% of patients who should be anticoagulated who are undertreated, underdosed, or discontinue treatment, and that's driven largely by physician concerns around bleeding risk.

I don't think it makes sense to speculate on hazard ratio, but what I can say is, our study, as Cristian mentioned, was designed to demonstrate a superior bleeding profile compared to ELIQUIS with comparable efficacy. Afib patients with bleeding liability risk factors are more likely to experience HCP hesitation today for anticoagulation treatment. For example, patients who are elderly, low body weight represent a high unmet need. Patients who have renal impairment. milvexian has the potential not just to unlock those patients, but also we expect milvexian to shift first-line decision-making over time, allowing physicians to initiate and maintain milvexian treatment more confidently than they can even do today by using ELIQUIS.

Thank you. On guidance, Chris, look, you saw in the results it was pretty pervasive across the growth portfolio. We saw really strong growth. Opdualag was up 22%, REVLIMID 29%, BREYANZI, we continue to see great growth there at 41%, and CAMZYOS was at 59%. As we also talked about the Opdivo Qvantig, now we have 15% share, so well on our way to that 30%-40%. It's now annualizing over $1 billion. If you look at Opdivo Qvantig and Opdivo together, we're really pleased with the progress of that franchise. It really is the underlying business coupled with the strong performance from a demand perspective on ELIQUIS that gives us confidence in our guidance for the year.

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

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

Hi, guys. Thank you for taking my question. I'm going to not ask one on milvexian or the ADEPT program, but taking a step back, you've been clear that BD remains a really important part of your long-term growth strategy. Can you just walk me through what excites you in biotech these days and kind of where you would look? I know you're not going to give specifics, but what type of technologies or therapeutic areas do you think would best fit within Bristol's portfolio? Thank you.

Maybe I'll start, then I'll ask Cristian to chime in. Thanks for the question, Evan. Business development, as you know and as we've discussed repeatedly, continues to be a top allocation priority. The way I think about BD just at a macro level is we've got a very strong late-stage pipeline. You see that in the commentary that we've made just this morning. We certainly don't feel any compulsion to chase deals. As we've said consistently, if there's an opportunity that we can find that has a few things that are important to us, notably they're in therapeutic areas that we know well, they're areas where the science is compelling, and of course, we need to be able to make a compelling case financially that we can drive value to the company and to shareholders.

If those things come together and ideally continue to enable us to de-risk our near-term growth profile, we certainly have the financial flexibility and the capabilities to be in the mix. That's been our guiding philosophy around business development for some time now, and it continues to be our focus. Cristian, are there particular areas you would highlight?

Thanks, Evan, for the question. I would frame it in the way I'm excited by what is new, what is innovative in terms of new targets, but also the way you deliver your drugs against that target, the modalities. This is where I think internally, but also looking external innovation continues to be very important. I want to give you some concrete examples. We know better and better the biology of the diseases where we are operating. Think cancer. Think neuroscience, cardiovascular. It's identifying targets that are becoming more and more relevant, and then the way we deliver against them. I want to give an example of an internal project that is our CELMoD BCL6 is coming from our protein targeted degradation platform. BCL6 is a key target in lymphomas, driving lymphomas. Because it's transcription factor, we're unable to inhibit them.

With the degrader we can. This is just an example. Imagine the potential in neuroscience. We are building up our Alzheimer portfolio, and we start to understand more and more on the biology of Alzheimer. The question is, how can we deliver against amyloid, against Tau, against new targets? How we can have better drugs to get into the brain? The shuttles is an example. These are the kind of, I hope I give you concrete examples on what I think innovation can look like, especially looking then at the development part that ultimately is our job.

The next question comes from Emily Field with Barclays. Please go ahead.

Okay, thanks so much for taking my question. Question on COBENFY and the approved schizophrenia indication. You've talked about one of the drags on sales being that clinicians aren't titrating up quickly enough to the therapeutic dose. Just wondering if you could give us an update on how the educational efforts on optimizing that are going and when perhaps we could see that reflected in the sales trajectory. If I could just sneak in another one on TYK2 in lupus. Obviously, a lot of readouts coming in the lupus space over the next couple of years. I was just wondering if you could highlight your confidence in the TYK2 MOA in this obviously notoriously difficult space. Thank you.

Good morning, Emily. Adam, maybe you could start, and Cristian, you can chime in as well.

Sure. Emily, let me just take the first part of your question about COBENFY. COBENFY continues to deliver steady growth, and we see significant upside coming from future label expansions. What we're seeing today in schizophrenia is a number of positive leading indicators for the brand that continues to give us confidence. We're encouraged by the positive trends in total script volumes. In fact, in the quarter, we saw roughly a 15% growth in TRx quarter-over-quarter. We're driving consistent increases in new prescribers, and physician feedback continues to be positive. That said, we have areas where we need to make further progress. We need to accelerate new patient starts as well as improve repeat prescribing. As we shared before, this is a disease state that prescribing behavior is deeply entrenched, and COBENFY will continue to grow by building more positive experiences in the market.

As far as dosing, we have been educating physicians on the importance of rapidly titrating COBENFY to the effective dose of 125 ml, as we see far too many patients that remain on either the 50 ml or 100 ml dose. What we have seen, though, is an increase in 125 ml prescribing since introducing our phase IV SWITCH study, which will both help maximize efficacy, but we need to see further increases in the dose shift towards the 125 ml. Taken together, we have a meaningful opportunity to continue to build confidence and bring clarity on how to maximize COBENFY use. Overall, we do expect COBENFY to grow consistently throughout the year with significant upside through a very broad LCM program. As far as Sotyktu in lupus, this is a market that is very different than the PSO market.

Sotyktu remains really a strategically important asset, which we believe could see renewed momentum with our new indications. SLE, which will read out this year, and Sjögren's will be out next year. In particular, a real need exists for more effective treatments. Those include treatments that reduce steroid dependence. That includes treatments that are associated with fewer side effects. What we saw in our phase II study gives us a lot of confidence. That study was one of the largest and most compelling in SLE to date, having met both the primary and key secondary efficacy endpoints. We believe we have a real opportunity to differentiate Sotyktu based on overall clinical responses, efficacy in skin and joint involvement, the ability to reduce steroid dependence, and also associated toxicity.

We very much look forward to our SLE data readout this year, as this could really catalyze growth for the brand.

Thanks Adam, and thanks Emily, for asking about these important readouts that will happen this year, both studies. As Adam say, the confidence stays on the phase II. Adam explained very well why the phase II were positive and positive for primary, most secondary points. It's not very typical in this space. Where I'm pleased is on the fact that we have been able to mimic the phase II study into the phase III studies. This is very important because when I look at patient demographics, disease characteristics, trial management, endpoints, everything is very matching. There are, in immunology, you have some kind of risks, sometimes related to placebo response. I think that our teams and investigators did a very good job in managing that risk in terms of checking carefully, steroid tapering, and actively monitoring the primary endpoint. Really looking forward on the readouts this year.

I think, as Adam said, this can be a very important oral drug to bring to these patients.

Great. Thanks, both. Let's move to the next question operator. Thank you.

The next question comes from Asad Haider with Goldman Sachs. Please go ahead.

Great. Thanks for taking the questions, congratulations on the quarter. Maybe for Cristian on amilparant. This now seems to be becoming the key clinical event for the balance of the year, given the updates that you guys just described. Just perhaps just level set us on expectations as we sharpen our pencils ahead of this readout. Can you contextualize where this fits into the IPF landscape if the clinical benefit turns out to be in line with currently available drugs, which have improved FVC by roughly 40%-50%? What would be the use case for adding it in? On the PPF side, is that trial still tracking to read out closely after IPF? Anything you can tell us on the filing strategy. Thank you.

Thanks, Asad. I'll start with Cristian and then maybe Adam, you can chime in as well.

Thanks. Thanks, Asad, for the question. You're right, this is becoming a very important readout and guided by the end of this year. Let me start with the mechanism of action. LPA1 is a very important novel target because it's not working only on the fibrotic and inflammatory pathway, but also potentially on the epithelium repair pathway. This is novel. We believe that amilparant can be first and best in class against the LPA1. The conviction on the phase III, again, sits on the phase II results, both in IPF and PPFs. You know the results were very positive for FVC primary endpoint. What we did, and we were able to do also in this setting, was ensure consistency how we run the phase II into the phase IIIs. Again, in terms of endpoints, population, overall criteria. There is an important aspect I want to highlight.

In phase III, we have two shots on goal in each of the studies, IPF and PPF, because we are testing two doses, 60 mg, it is the dose that emerged from the phase II, but also 120 mg that was introduced later. We know there is a dose relation activity, and this give us more chances with both doses. Also looking overall at the study conduction and how the blinded data emerging on the safety side very well. Overall, I have to say I'm really looking forward to these readouts because the profile of this drug can be very helpful for patients with both IPF and PPF. To IPF guided this year, PPF, to the second part of your question, will be just a few months after, so very same ballpark timelines beginning next year. Adam, you want to speak about the positioning?

Yes. No, thanks for the question, Asad. amilparant has the potential to play a truly meaningful role in both IPF and PPF, as we expect an improved efficacy and tolerability profile. There is still a significant unmet need for new and improved therapies that slow disease progression, potentially even halting disease progression, that are well-tolerated and ultimately help patients better manage their disease. Now remember, GI tolerability remains a significant challenge with current agents in the market. In fact, 50%-60% of IPF patients continue to stop their medications by 12 months, and that's with current standard of care. What you've seen in the most recent launch, it clearly validates the market opportunity. That there is an opportunity to gain significant share as better tolerated and more effective new treatment options emerge.

What we're seeing happen in the market today is the emergence of a large second-line add-on and SWITCH market for the first time. We're seeing that with Jascayd, over 50% of their starts are coming after generic. Today, this is a roughly $4 billion market. We expect this market to grow significantly with improved treatments that could maybe double to $8 billion-$10 billion by the middle of the 2030s with improved treatment options. We believe that admilparant truly has the potential to be foundational as a first-branded option with the versatility of being used in combination. We very much look forward to the readout in the back half of this year.

All right. Thanks, both. Next question, please.

The next question comes from Seamus Fernandez with Guggenheim Securities. Please go ahead.

Oh, thanks so much for the question. Wanted to drill in a little bit on the CELMoDs. We've got two assets that are either filed or fileable with the agency. Just wanted to get a better sense of how in, let's say, 2028-2030, how you see the CELMoDs actually contributing to the growth revenue for the company. This does seem like a multibillion-dollar, perhaps even a double-digit billion-dollar potential opportunity if the earlier-stage studies read out positively. Even in the existing indications that you see today, what kind of contribution do you see coming from your CELMoD portfolio? Thanks.

Thanks, Seamus. Great question, obviously, we're quite excited about the platform and both Iber and Mezi, Adam, you can chime in.

Yeah. No, thank you, Seamus, for the question. Clearly, CELMoDs represent a significant commercial opportunity, we're confident that both iberdomide and mezigdomide will deliver very strong growth for the company. We're very much looking forward to iberdomide's PDUFA date, which is just a few weeks away, our commercial teams are launch-ready. We're also pleased to have a PDUFA date set for mezigdomide, as you had heard earlier on the call, which will come in May of next year. Let me just step back.

Recall that 70%-80% of patients are treated with multiple myeloma in the community, and both Iber and Mezi are able to provide a balance of high potency, they're able to provide a manageable and very familiar toxicity profile that are able to provide a better experience for patients with the convenience of an oral treatment that fits within the workflow of their practice. Iber will replace Pomalyst and REVLIMID in the leading triplet regimens in second-line and combined with daratumumab and will amplify the efficacy of current IMiD-based regimens. Our goal is to make Iber and Mezi foundational in multiple myeloma, replacing Rev and Pom in second-line over time.

We do expect strong adoption in the community, and PFS data should be available within just a few months after our approval, which will certainly help accelerate uptake, as some physicians are going to want to see PFS data before adopting. We are ready to launch. We know the work we need to do to establish both Iber and Mezi in the market. We're also excited about the upcoming readouts for golcadomide, which will be the third CELMoD in the market that has the opportunity to really revolutionize first-line LBCL and also play a significant role in second-line follicular lymphoma. We're excited to bring these important medicines to patients, and we know these three drugs will provide meaningful contributions to growth for the company.

Adam, thank you. Let's move to the next question, please.

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

Thanks. Two questions, both for Cristian. On IPF, can you just talk a little bit about the 120 dose that you're using and how you feel about how much more efficacy that could add and what exposure analysis data you might have seen there in the context of also blood pressure questions and how you feel about the risk-benefit of the 120? Perhaps just a clarification on milvexian. I know that everyone's asking about hazard ratios, but just so that you could confirm, I would assume that as a non-inferiority study, you expect the hazard ratios, certainly on the upper bound, to be well above 1.0, but as long as it's non-inferior, that that is a win for you. Just wanted to clarify and confirm. Thank you.

Thanks, Mike. Cristian, you can start, Adam, you can just chime in with any additional detail on milvexian.

Thank you, Mike, for the question on IPF. As I said, we introduced the 120 ml dose based on some work coming, modeling work, showing that there was a dose relation. You remember in the phase II, we tested 30 ml, 60 ml, 60 ml was the dose showing better and higher benefit, this is what we brought in phase III. At the start of the phase III, there was a randomized run-in introducing 120, DMC have seen this data and cleared that dose. We believe that there is a dose relation. As you mentioned, the real unknown for the conduction of the study was 120 safety profile in terms of hypotensions. What I can tell you is that DMC is monitoring regularly the study. We completed the recruitment. We are waiting the readout.

There was, in a blinded way, a very reassuring events safety profile rate. This increase the confidence that we have two shots on goal, the studies are fully powered for both doses. Related to milvexian, again, we remain blinded, you're right, the margins on non-inferiority are a range that is around 1, but the study is fully designed and powered to show another ratio of 1. This is what we expect, milvexian being as good as ELIQUIS in terms of stroke and systemic embolisms, then, of course, being better on bleedings.

Yeah. Just as far as what we're hearing from our physicians, I think, number one, physicians, payers, as we meet with them, they're not anchored on a specific percentage threshold. What they're looking for, though, is clinically meaningful reduction in major bleeding that translates into fewer events, fewer hospitalizations, and ultimately a lower cost in treating Afib patients. It's why ELIQUIS continues to play such a prominent role in the marketplace. Our customers focus on whether treatment enables them to have broader and more confident use of anticoagulation, preserving stroke protection while improving the safety margin has a potential to really meaningfully reshape the treatment dynamics that we see today.

We believe that the profile that we have described, and we fully expect, will drive significant demand and will be important for payers, patients, and providers.

Okay, thank you. Operator, let's take our next question, please.

The next question comes from Jason Gerberry with Bank of America. Please go ahead.

Hey, guys. Thanks for taking my question. Another one on IPF and maybe for Adam. Just given the really strong launch of Jascayd by BI, does this impact the bar for success, in your view? Does it elevate maybe the commercial bar for success? Or is potentially winning and differentiating versus Jascayd mainly on tolerability? Do you see the market potentially moving to polypharmacy, much like markets like pulmonary hypertension? Just wanted to get your perspective on some of those market considerations. Thanks.

Yeah. Jason, Go ahead thanks for the question. As we said, Cristian and I both shared, IPF and PPF remains a market with significant unmet needs, and those needs are in both efficacy and tolerability improvement. Admilpron, as the first ever LPA1 antagonist, has the potential to play a real significant role. We expect both improved efficacy and improved tolerability, specifically as it relates to GI toxicity, which even what we see today with some of the most recently approved products, has an overall rate of diarrhea of 40%, over 60% in combination. What we've seen with Admilpron in our phase II studies is a side effect profile that is comparable to placebo. I think, what you're getting at is right. Jascayd's launch validates the market opportunity and shows there's an opportunity to gain significant share as better tolerated and effective new treatment options emerge.

That's what we're seeing. We're seeing the creation of a second-line add-on market for the first time ever, as over 50% of new Jascayd starts are coming after generic Ofev or generic Esbriet as switch or add-on treatments. We'll see this part of the market grow substantially after generic use. Clearly, we'll see a big market in polypharmacy or in switch and add-on. As I talked about, this is a market that we think could double in size over time with improved treatment options. Admilpron certainly has the potential to be foundational, both as a first-branded option in monotherapy, with the versatility of being used in combination, given what we expect to be a really exciting efficacy profile and tolerability profile.

Great. Let's take our next question, please.

The next question comes from David Amsellem with Piper Sandler. Please go ahead.

Thanks. I had a question about your tau program with the data coming next year. Just with the recent data from Biogen's donanemab, their tau ASO, and just given the body of data for the Abeta therapies, wanted to get a better sense from you on what you'd like to see from CDR-SB some of the boxes and just the totality of the data that you get next year for moponitat in order to justify moving forward, and then also what you're seeing with that molecule that potentially differentiates it from donanemab. Thanks.

Thank you for the question, David. Our anti-tau antibody, moponitat, is a very potential best-in-class, important anti-microtubule binding region tau. I'm specific on this because there are many antibodies out there, but I think binding R1 and R3 domains in the MTBR, in the microtubule region, is believed to be very important because it is a critical area that lead to formation and spread of the tau tangles. The job of the drug is blocking this spread from one neuro to another. We did the phase I, and the phase I was very reassuring in terms of the safety and tolerability of the product. Now we completed the recruitment of the phase II. The readout of the phase II is going to be next year.

Bristol-Myers Squibb (BMY) Q2 2026 Earnings Call Transcript

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