Bristol Myers Squibb Q2 2026 Earnings Report

Bristol Myers Squibb EPS Results

• Actual EPS: $2.04
• Consensus EPS: $1.60
• Beat/Miss: Beat by +$0.44
• One Year Ago EPS: $1.46

Bristol Myers Squibb Revenue Results

• Actual Revenue: $12.97 billion
• Expected Revenue: $11.74 billion
• Beat/Miss: Beat by +$1.23 billion
• YoY Revenue Growth: +5.70%

Bristol Myers Squibb Announcement Details

• Quarter: Q2 2026
• Date: 7/30/2026
• Time: Before Market Opens
• Conference Call Date: Thursday, July 30, 2026
• Conference Call Time: 8:15AM ET

Bristol Myers Squibb (NYSE:BMY) is a global biopharmaceutical company headquartered in Princeton, New Jersey, focused on discovering, developing and delivering medicines for serious diseases. The company's core activities include research and development, clinical development, manufacturing and commercialization of prescription pharmaceuticals across multiple therapeutic areas. BMS concentrates on advancing therapies in oncology, hematology, immunology, cardiovascular disease and specialty areas through both small molecules and biologics.

BMS's marketed portfolio and late‑stage pipeline reflect a strong emphasis on cancer and immune‑mediated conditions. Notable products developed or marketed by the company include immune checkpoint inhibitors and combination oncology regimens, anticoagulant therapies, and immunomodulatory agents. The company maintains a sizable R&D organization and invests in clinical development, translational science and collaborative research to expand indications for existing therapies and to advance novel modalities such as targeted agents and cell‑based approaches.

The modern Bristol Myers Squibb was formed through the 1989 merger of Bristol‑Myers and Squibb, and it expanded materially with the acquisition of Celgene in 2019, which significantly broadened its hematology and oncology franchise and added a substantial product and pipeline base. BMS has a history of pursuing strategic licensing agreements, partnerships and acquisitions to complement internal discovery efforts and to access new technologies and therapeutic candidates.

BMS operates globally, serving patients and healthcare systems across North America, Europe, Asia and other regions through direct commercial operations and partner networks. The company is led by a senior executive team responsible for corporate strategy, R&D and global operations; as of the most recent public disclosures the company’s chief executive officer is Giovanni Caforio. Bristol Myers Squibb continues to prioritize innovation, regulatory engagement and collaborations with academic and industry partners to address unmet medical needs.

Bristol Myers Squibb Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Second-quarter results exceeded expectations: Revenue increased 5% to approximately $13 billion, with the growth portfolio up 14% to $7.6 billion and adjusted EPS of $2.04. Management raised its full-year 2026 revenue and adjusted EPS guidance.
• Positive Sentiment: Growth was broad-based, led by ELIQUIS demand growth of 21%, BREYANZI growth of 41%, CAMZYOS growth of 59%, REBLOZYL growth of 29%, and continued momentum for Sotyktu and Opdivo Qvantig. Management now expects ELIQUIS revenue growth of 20%-25% for 2026.
• Positive Sentiment: The company highlighted multiple potential pipeline catalysts, including late-2026 readouts for amilparant, Sotyktu in lupus, milvexian in secondary stroke prevention, and several oncology programs. Iberdomide’s FDA decision is expected August 17, 2026, while mezigdomide has a May 2027 PDUFA date.
• Negative Sentiment: Timelines for important studies have moved later: milvexian’s atrial-fibrillation readout is now expected in the first quarter of 2027, while COBENFY’s ADEPT program readouts will begin in early 2027 and extend through the year. Management attributed the delays to slower event accrual and efforts to preserve study quality, while maintaining confidence in the programs.
• Positive Sentiment: Bristol Myers Squibb reported approximately $3.4 billion in second-quarter operating cash flow, $11.5 billion in cash and marketable securities, and another $1.2 billion of debt repayment. Productivity savings and financial flexibility are supporting continued pipeline investment, potential business development, and shareholder returns.

Presentation

[Operator]

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.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

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.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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%.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[David Elkins, CFO at Bristol Myers Squibb]

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.

[David Elkins, CFO at Bristol Myers Squibb]

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.

[David Elkins, CFO at Bristol Myers Squibb]

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.

[David Elkins, CFO at Bristol Myers Squibb]

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.

[David Elkins, CFO at Bristol Myers Squibb]

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.

[David Elkins, CFO at Bristol Myers Squibb]

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%.

[David Elkins, CFO at Bristol Myers Squibb]

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.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

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

[Operator]

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.

[Geoff Meacham, Analyst at Citi]

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.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

Morning, Geoff. Thanks for the question. Cristian?

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

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

[Operator]

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

[Chris Schott, Analyst at JPMorgan]

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?

[Chris Schott, Analyst at JPMorgan]

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

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[David Elkins, CFO at Bristol Myers Squibb]

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.

[Chris Schott, Analyst at JPMorgan]

Thanks, guys.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

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

[Operator]

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

[Evan Seigerman, Analyst at BMO Capital Markets]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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?

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Evan Seigerman, Analyst at BMO Capital Markets]

Thanks, Cristian.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

Let's take our next question, please.

[Operator]

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

[Emily Field, Analyst at Barclays]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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

[Operator]

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

[Asad Haider, Analyst at Goldman Sachs]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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?

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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

[Operator]

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

[Seamus Fernandez, Analyst at Guggenheim Securities]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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

[Operator]

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

[Michael Yee, Analyst at UBS]

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.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

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

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

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

[Operator]

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

[Jason Gerberry, Analyst at Bank of America]

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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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 amilparant 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.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

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.

[Jason Gerberry, Analyst at Bank of America]

Thanks, Adam.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

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

[Operator]

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

[David Amsellem, Analyst at Piper Sandler]

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.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

Cristian?

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

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.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

As you said, it's an exciting moment because what is emerging is that the tau clearance is impacting cognition in Alzheimer patient with mild impairment and cognitive impairment, and this can translate maybe into clinical benefit. As you can imagine, our phase II study will assess tau clearance, but will assess also some endpoints related to cognition and potential overall clinical benefit. This will give us the way forward for the next stage of the development.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

I'm very excited about this space in general. We have now a second mechanism validated, Tau on top of amyloid. I think now started to emerge also the discussion how we sequence this anti-amyloid versus anti-Tau drug, how we combine them. For us, it is an entry, because, of course, we are very much into this space and developing the next generation of assets that are shuttles to increase the brain penetration. Very excited about moponitat and see the data next year.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Thanks, Cristian. Great. Next question, please.

[Operator]

The next question comes from Luisa Hector with Berenberg. Please go ahead.

[Luisa Hector, Analyst at Berenberg]

Hello. Thank you for taking my question. I wanted to just check on milvexian a little bit around how nimble you can be around launch costs. Do you need to pull back on any investment due to this delay, or is it just a matter of a quarter is not a big deal? With that in mind, could you remind us the setup? I mean, ELIQUIS, you have the sales force, you've had the rebate, you've had some changes there with IRA and pricing. As we think about the future ELIQUIS and then milvexian hopefully launching, are there any constraints in that partnership with Pfizer on ELIQUIS that makes things more difficult when you launch milvexian? Just anything we should think about there, or your sales force and your rebate are kind of transferable. Thank you.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Adam, you want to take that?

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

Sure. Luisa, thanks for the question. As you said, milvexian represents a significant commercial opportunity. What's great about milvexian is we have the infrastructure that has been established now for many years with ELIQUIS. We have that in place today covering virtually all of the physicians in atrial fibrillation. It's also a high overlap with SSP as well, save for a small number of stroke neurologists that we'll be able to cover in the market today with our current Zeposia team. We really have the full infrastructure commercially set, and we're very much looking forward to launching. As far as the interplay with ELIQUIS LOE, as you're aware, is April of 2028, and this lines up very nicely with the filing and launch timelines of milvexian. We expect that ELIQUIS LOE to lead directly into the successful launch of milvexian.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Yeah. Just to follow up, there would be no constraints with respect to the relationship that we have with Pfizer in terms of our ability to successfully launch and commercialize milvexian. Thank you both. Let's move to the next question, please.

[Operator]

The next question comes from David Risinger with Leerink Partners. Please go ahead.

[David Risinger, Analyst at Leerink Partners]

Thanks very much, and thanks for all the updates. Chris, regarding milvexian and atrial fibrillation, you had stated in your prepared remarks, quote, "An independent data monitoring committee continues to endorse the study, and with the passage of time as the study progresses, we are increasingly encouraged about milvexian," end quote. Can you please comment further on the endorsement, including how you're interpreting study continuation as a positive signal when the DMC is evaluating both efficacy and bleeding? I ask because it's already known and clear that milvexian is associated with much lower bleeding risk than ELIQUIS. That is not any surprise that lower bleeding would be positive in the trial. I'm more interested in your interpretation on the primary endpoint of efficacy with respect to your observations. Thank you.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Sure. Thanks, David. Maybe I'll start, and then Cristian, you can continue to chime in or extend upon your earlier comments. Look, we continue to see on a routine basis the DMC looking, as you note, at both safety and efficacy. If you look not only at the most recent reviews, but really just look at this over time, we've continued to see on this program a slowing of event rates along with the continued view that the efficacy continues to be in line with expectations to continue the study. The safety, as you point out, we had a lot of confidence in.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

In the backdrop of this broader program from a competitive standpoint, the fact that we continue to see DMC reviews and that as we look at the blinded data and see the event rate profile, we continue to gain confidence that this program has significant potential to read out in a way that would be a competitive product relative to the position that we have with ELIQUIS. Cristian, do you want to comment further?

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

Yeah, David. Let me use an analog in the same disease, Afib, with the same class drug. One study was in recent times stopped by the DMC based on regular data review because the events were going in a different direction. There was actually a potential detriment on the primary endpoint on strokes and embolisms in the investigational arm versus the comparator arm ELIQUIS. The DMC stopped the study because that was becoming a problem. Having DMC continues to assess the efficacy and safety data, as you say, and giving us very much closer to the final readout, the reassurance that the study can progress as planned is a good thing. Is a good thing because at least we are sure that we are not bringing anything that goes against the patients or detriment to the patient on efficacy.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

Remember that this study needs to show non-inferiority, needs to be as good as ELIQUIS on strokes. Considering the number of events that we recruited so far, the pace of the events and the DMC continuous review, this looks good. Then, as you said, the bleedings, probably milvexian going to be better than ELIQUIS. This is that expectations.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

If you just step back in this program generally, David, what I would say is that you continue to have very strong scientific rationale. We know the strong phase II data that we had. As you've highlighted, we know the safety and on efficacy, given the event profile and how it's evolving in a blinded fashion and DMCs continued to endorse the continuation of the study. You add all of that up, we feel very good about this program.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

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

[Operator]

The next question comes from Steve Scala with TD Cowen. Please go ahead.

[Steve Scala, Analyst at TD Cowen]

Oh, thank you so much. I have two questions. First, how will the increased growth of ELIQUIS in 2026 impact sales in 2027 and beyond? Is it a tailwind, a headwind, or neither in 2027? Is any portion of those revenues in 2026 sustainable? Secondly, after a number of phase III setbacks in recent years, Bristol actively addressed study conduct deficiencies. Curious where you stand relative to resolving them and are milvexian and COBENFY delays completely unrelated to any lingering study conduct issues, such as maybe assessment of primary events? Thank you.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Thanks for the question, Steve. Maybe Adam, you want to start with ELIQUIS, and then Cristian, you can address the second part of the question.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

Steve, thanks for the question. ELIQUIS continues to deliver strong demand growth. In fact, in the U.S., new to brand share is approaching 80%. As we said, coming into this year, we would see the benefit of the WAC reduction taken January 1st in the second half of the year, and thus sales in the U.S. in the second half would be higher than in the first half of the year. As David talked about, ELIQUIS sales this year are anticipated to grow roughly 20%-25% year-over-year. We still expect the $1.5 billion-$2 billion step down in 2027 that we referenced on the Q1 call. We'll clearly provide any appropriate update in conjunction with our 2027 guidance when issued.

[Adam Lenkowsky, Chief Commercialization Officer at Bristol Myers Squibb]

The U.S. sales certainly would carry forward to next year, offset by the patent expiry of ELIQUIS in Europe in mid Q4.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Cristian?

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

Thank you, Steve, for the question. Very broad one. Let me start with a general concept. A phase III trial can fail if the science doesn't hold. You cannot do a lot on that. Most of the time fails because also execution can be related to the execution. Execution means not only how you run the trial, but also the study design, the statistical assumptions, the comparator arm performance and so on. What we did as a general way of working was to identify in any of the ongoing studies potential risks and mitigate them. Because this is with none, it's impossible to have 100% probability of success in any of the registrational studies. You want to get as close as possible to that. This is what now we are working, integrating AI technology, data, and everything to have for each program this PTS improvement.

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

Milvexian and COBENFY delays are unrelated in a certain way because milvexian is event-driven, and actually the event is slowing down, I see favorably, because it bring us on what we were expecting. For COBENFY, quality is another potential aspect that can lead to failure of studies, and preserving quality is capital to increase success. This is one of the reason for ADEPT-2 and ADEPT-4 of the delay. ADEPT-1 again, is event-driven, and actually event count is lower can be a good sign.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Steve, let me just weigh in on maybe that last comment. Cristian's approaching his one-year anniversary at the company, and I just want to say I'm incredibly pleased with the progress that he and the team have made. He has been consistently focusing on making sure we have the right scientific talents and expertise across therapeutic areas. He's brought an incredible focus on being great operationally. He's made good progress on ensuring we've got the right infrastructure and ways of working. At the end of the day, we continue to make sure that we're investing in the right areas of science where the company can be successful. If you add all of that up, I feel very good that the R&D engine that he's helping to build is going to sustain the growth of this enterprise.

[Chuck Triano, SVP and Head of Investor Relations at Bristol Myers Squibb]

Great. Thanks. Operator, if we could please take our last question.

[Operator]

The last question today will come from Akash Tewari with Jefferies. Please go ahead.

[Akash Tewari, Analyst at Jefferies]

Hey, thank you. Just a clarification on milvexian. You previously mentioned both bleeding events and Afib events need to mature for the trial to stop. Are both bleeding and Afib tracking slower than expected, or have we already reached the required number of events for bleeding events already? Thank you.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Cristian?

[Cristian Massacesi, CMO and Head of Development at Bristol Myers Squibb]

Thank you, Akash. I don't drive on the number of events. What I can tell you, because we disclose this, we need to recruit 430 events for primary endpoint, strokes and embolisms, and 530 event for bleedings. We want to achieve both numbers before locking the database and have it read out, because the primary endpoint is very important, but also then how we test the superiority on bleedings is also very important. We are on track for this, and this will happen first quarter 2027.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Thanks, Cristian. Let me just say in closing that I just want to reiterate that a big focus of the team has been to drive what we call a say-to-do ratio, and I think what you're seeing in the performance for the quarter is that we're doing what we said we would do. Today's results really underscore the impact of what we see as a multi-year strategy to reshape our business and drive sustainable growth. We're delivering very strong commercial execution across our growth portfolio. We're advancing a broad and differentiated pipeline, while being very disciplined and maintaining the financial flexibility that we need to invest in future growth, while also of course, returning capital to shareholders. We continue to strengthen the company through focused execution, and we're very confident in the long-term trajectory of the business.

[Chris Boerner, Board Chair and CEO at Bristol Myers Squibb]

Finally, I'd like to just thank our colleagues around the world for their continued dedication to the mission that we have and to their focus on serving our patients. Thank you all for joining us today, and as always, we'll be available for any follow-up questions. Thanks.

[Operator]

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Participants

Executives

• Chuck Triano, SVP and Head of Investor Relations
• Chris Boerner, Board Chair and CEO
• David Elkins, CFO
• Cristian Massacesi, CMO and Head of Development
• Adam Lenkowsky, Chief Commercialization Officer

Analysts

• Geoff Meacham, Analyst at Citi
• Chris Schott, Analyst at JPMorgan
• Evan Seigerman, Analyst at BMO Capital Markets
• Emily Field, Analyst at Barclays
• Asad Haider, Analyst at Goldman Sachs
• Seamus Fernandez, Analyst at Guggenheim Securities
• Michael Yee, Analyst at UBS
• Jason Gerberry, Analyst at Bank of America
• David Amsellem, Analyst at Piper Sandler
• Luisa Hector, Analyst at Berenberg
• David Risinger, Analyst at Leerink Partners
• Steve Scala, Analyst at TD Cowen
• Akash Tewari, Analyst at Jefferies