Q4 2025 Earnings Call Transcript

All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note, today's 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 fourth quarter 2025 earnings call. With me this morning with prepared remarks are Christopher 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 Christopher Boerner and David Elkins' remarks. Before we get started, I'll remind everybody that during this call, we will make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date, and we specifically disclaim any obligation to update forward-looking statements even if our estimates change.

We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com. Finally, unless otherwise stated, all comparisons are made from the same period in 2024, and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. All references to our P&L are on a non-GAAP basis.

And with that, I'll hand it over to Christopher Boerner. Thanks, Chuck. Welcome, and thank you for joining us this morning.

2025 was a year of focused execution across the business. We believe our results further demonstrate the ongoing strength in our growth portfolio as we advance our multiyear plan to rewire Bristol-Myers Squibb Company for long-term growth. These efforts enabled us to enter 2026 with good momentum. Let me start by highlighting our recent progress on slide four.

We closed the year with strong fourth-quarter performance. Our growth portfolio grew 15% year over year in Q4 and 17% for the full year. In terms of building out breadth, with newer products, Opdualag, Breyanzi, and Camzyos each contributed over $1 billion in sales for the full year, while Reblozyl delivered over $2 billion. These are differentiated durable products early in their life cycles with meaningful runway ahead that further strengthen the foundation for long-term growth.

And on a full-year basis, it is worth pointing out that despite a decline of roughly $4 billion in revenue from our legacy portfolio, the growth portfolio nearly offset all of that. CoBinfy and Qvantik also continued to progress well and in line with our expectations. With CoBinfy, we saw steady growth as we expanded access and deepened adoption across community and hospital settings. And we expect this steady growth to continue throughout the year.

Qvantik continued to receive positive early feedback from users with improved practice efficiency and patient preferences as the main drivers. David Elkins will provide more detail on our portfolio's performance shortly. Turning to recent clinical and regulatory highlights. In December, Breyanzi received FDA approval as the first and only CAR T cell therapy for adults with relapsed or refractory marginal zone lymphoma.

It is now approved across five cancer types, strengthening its leadership position among CD19-directed CAR Ts. In December, with our partners at BioNTech, we also shared the first global phase two data for pemigatinib in locally advanced or metastatic triple-negative breast cancer. These data showed encouraging antitumor response and a manageable safety profile in both the first and second-line treatment settings. Triple-negative breast cancer remains an aggressive disease where there is an urgent need for new treatment options.

And within the overall pemigatinib development partnership, we recently announced three additional planned studies resulting in eight registrational studies we expect to have underway by year-end. We are pleased to announce that two of these studies in non-small cell lung cancer are now initiating in unresectable stage three disease and in first-line high PD-L1 expression. We also just posted details regarding our global phase three study Break Free SSC for Zolacel, our CD19 CAR T, now initiating in patients with active systemic sclerosis. Finally, we very much look forward to the first oral data presentation of Nablometastat, a potential first-in-class PRMT5 inhibitor.

This will be combination data in the pancreatic setting and will be showcased at the ESMO Targeted Anticancer Therapies Conference next month. These milestones reinforce the momentum of our pipeline with more readouts to come this year, which I'll talk about on slide five. As we shared last month, this is a data-rich period for 10 new medicines and over 30 meaningful launch opportunities by 2030. The increasing pace of pivotal readouts later this year will serve to better define the potential of our pipeline candidates. We are confident in our ability to deliver an attractive and durable growth profile heading into the next decade.

The breadth and depth of these opportunities are illustrated on this slide. This year alone, we expect to report top-line registrational data for six potential new products. Nilvexin in both atrial fibrillation and secondary stroke prevention, admilparent in idiopathic pulmonary fibrosis, iberdomide, where we have already demonstrated a significant improvement in MRD negativity rates, mozignamide and arlocell in relapsed or refractory multiple myeloma, and raise one zero one in second line plus GAP nets. We also anticipate meaningful pivotal line extension readouts for SOTIC two and lupus and CoBINFI in Alzheimer's disease psychosis.

Most of these readouts will occur in the second half of the year. And we have more data readouts coming beyond 2026. Together, these represent an attractive set of near-term catalysts that can meaningfully enhance the long-term growth profile of our current growth portfolio. We communicated at the start of last year that getting the long term right means executing well in the near and medium terms. As you can see from our results, we continue to deliver the organization in 2025. Maintaining this strong say-to-do ratio by delivering on our commitments has now been embedded in our culture and will continue to be core to how we operate.

As you have seen in our financials, we delivered on our cost savings initiative in 2025 and we'll continue to expand the use of AI to help us move faster, operate leaner, and reinvest strategically in growth. Our financial strength continues to allow us to invest in our business and bring exciting science into the company through the pursuit of high-return business development. Our North Star remains to deliver industry-leading sustainable growth into the 2030s and beyond. Now let me give you a high-level overview of our 2026 guidance on Slide six, and David Elkins will speak to it in more detail shortly.

We currently anticipate 2026 revenue in the range of $46 to $47.5 billion. This range reflects continued strong performance from our growth portfolio and a projected revenue decline for our legacy portfolio of between 12-16% given the ongoing LOE impacts. Within the legacy portfolio, we project Eliquis growth this year to be in the range of 10% to 15%. This is driven by continued global demand growth and the recent price reduction which expands patient access and eliminates the associated inflation penalty.

We expect lower operating expenses compared to last year, due to our ongoing cost savings program. And we expect adjusted diluted earnings per share of between $6.05 and $6.35. With that, I'll turn it over to David Elkins. Thank you, Christopher Boerner, and good morning, everyone.

I will begin my review of our 2025 financial results focusing on our fourth-quarter performance. I will follow up with the introduction of our non-GAAP financial guidance for 2026 and some considerations to help you better understand our financial outlook for this year. We had very strong commercial and financial performance in 2025, marked by focused execution on driving top-line growth and generating strong cash flow while strengthening our balance sheet and continuing to manage our cost structure. We've entered 2026 in a position of strength with a solid foundation, which we can continue to build upon to deliver on our long-term growth strategy.

Starting with slide eight, total revenue in the fourth quarter was flat year over year at approximately $12.5 billion. Our growth portfolio continued its positive momentum, with revenue increasing 15% to $7.4 billion and representing close to 60% of our total revenue in the quarter. Key brands including Reblozyl, Breyanzi, Camzyos, and our IO portfolio all achieved significant growth and were further supported by our early launches of CoBinfy and Qvantik. Within the legacy portfolio, higher revenue from Eliquis was offset by the continued impact of increased generic volumes across several other brands.

All in, we are very pleased with the results in the fourth quarter and the full year. As our growth portfolio performance continues to reshape and redefine Bristol-Myers Squibb Company as we strive to be one of the fastest-growing pharmaceutical companies into the next decade. Turning to product performance on slide nine, starting with oncology. Opdivo again delivered solid growth in the fourth quarter, with revenue up 7% to nearly $2.7 billion.

This was driven by new indications and continued share growth within the first-line non-small cell lung cancer setting. Qvantik's launch continued to progress well with revenue of $133 million in the quarter. With Opdualag, delivered another quarter of strong double-digit growth, driven by demand in the U.S. where it remains a standard of care in first-line melanoma. Turning to slide 10. Reblozyl delivered 21% growth with performance reflecting solid uptake across first and second-line MDS-associated anemia patients.

Over the past two years, we've delivered a very strong launch for Reblozyl. In cell therapy, Breyanzi's fourth-quarter revenue continued to show impressive growth with revenue up 47%, driven by its desirable profile and continued strong demand across its approved indications. We continue to be encouraged by Breyanzi's growth prospects into 2026. Moving to cardiovascular on slide 11. Eliquis delivered nearly $3.5 billion in fourth-quarter revenue, an increase of 6%. This was driven by demand growth and market share gains with U.S. revenue increasing 4%.

Turning to Camzyos, revenue in the fourth quarter grew 57% to $353 million, benefiting from continued demand growth globally. In the U.S., we expanded the number of physicians who are prescribing the drug, and outside of the U.S., we have now launched in over 50 countries. Now moving to immunology. Global revenue of Sotyktu grew 3%.

We look forward to our upcoming PDUFA date for psoriatic arthritis and our phase three readouts for lupus and Sjogren's disease. I will wrap up by reviewing our product performance for the quarter on slide 12 with neuroscience. CoBinfy revenue in the fourth quarter was $51 million, with continued steady uptake among prescribers and patients. CoBinfy's uptake has surpassed all schizophrenia comparators and relevant analogs in the first year of launch, and we continue to expect steady growth throughout the year.

Let's move to the P&L on slide 13. As expected, gross margin declined 210 basis points in the fourth quarter to 71.9%, driven primarily by product mix, notably Eliquis and Revlimid. Regarding our operating expenses, we made significant progress during 2025 against our $2 billion strategic productivity initiative. As of the end of the fourth quarter, we delivered on a target of approximately $1 billion in savings in 2025, and are on track to realize the remaining billion dollars over 2026 and 2027. Excluding in-process R&D, operating expenses for the full year were $16.6 billion, a decrease of $1.2 billion from 2024. This reflects our ongoing cost savings program partially offset by continued investment behind growth initiatives.

Our effective tax rate in the quarter was 22.1%, compared to 19.9% in the prior year. With the effective tax rate in 2025 reflecting the one-time non-tax deductible in-process R&D charge related to the Orbital acquisition. Overall, diluted earnings per share were $1.26 for the quarter, and full-year diluted earnings per share came in at $6.15. Both include a net charge related to in-process R&D and licensing income, which totaled 60¢ per share in the quarter and $1.40 for the full year. Now turning to the balance sheet and capital allocation highlights on slide 14. Our financial position remains strong with approximately $11 billion in cash equivalents and marketable securities as of 12/31/2025. We completed our targeted $10 billion of debt paydown ahead of schedule and generated strong cash flow from operations of approximately $2 billion in the fourth quarter.

In terms of capital allocation, we continue to ensure we employ a strategic and balanced approach. Business development remains a top priority, while also returning cash to shareholders through our commitment to the dividend. Now let me walk you through our non-GAAP 2026 guidance on slide 15 starting with revenue. As Christopher Boerner mentioned earlier, we estimate revenue to be between $46 and $47.5 billion in 2026. We expect our gross margin to be between 69 to 70%.

This reflects the impact of product mix, notably the combination of higher Eliquis and lower Revlimid and Pomalyst revenue. We expect total operating expenses to decline from 2025 levels to approximately $16.3 billion. Our cost savings program has provided us with the flexibility to increase commercial where appropriate and support newer development programs, such as our partnership on pemigatinib and our orbital therapeutics program. Even with these investments, we expect to reduce costs year over year.

We are expecting our OI and E expense of approximately $700 million, which reflects the expiry of our royalty-bearing license of diabetes products at the end of 2025. We expect to maintain our tax rate of approximately 18%. Considering these factors, we expect to deliver non-GAAP earnings per share in the range of $6.05 to $6.35. Before closing, let me provide some insight regarding our expected quarterly progression of revenue for 2026. As it relates to quarterly phasing, we expect our typical sequential revenue decrease in the first quarter due to the seasonal inventory destocking we see each year following the build in the fourth quarter.

And two points on Eliquis. First, anticipate that the second-half revenue will trend higher than the first half of the year. And second, in terms of Eliquis-specific updated guidance. We currently expect 2027 Eliquis sales compared to 2026 to show a step down in the range of $1.5 to $2 billion, which is broadly consistent with analysts' existing estimates.

In closing, our strong performance in 2025 demonstrated our confidence in our ability to deliver long-term value for our patients and shareholders. We remain focused on executing our growth strategy, advancing our pipeline, and optimizing our cost structure. We look forward to updating you on multiple data readouts this year. And with that, now turn the call back over to Chuck Triano for Q&A.

Thank you.

We'll now begin the question and answer session. And today's first question comes from Seamus Fernandez with Guggenheim Securities. Please go ahead.

Great. Thanks for the questions and congrats on the good quarter and the guide. Now that we're past the guidance, this is a question for the overall team, but know, it's been a long time since we've seen, as you know, an overall analyst community, a series of phase three pivotal catalysts that Bristol-Myers Squibb Company has ahead of it in 2026. Christopher Boerner, I know you counted six. There may be in addition to that, potential benefits from royalty agreements around sotatercept and cadence.

Just wondering if you could help us position the areas that you see the most kind of relative upside. The CELMoDs are obviously something that Bristol-Myers Squibb Company has been working on for a very long time, and we're just on the cusp of seeing the material data. We've got Novexian and a very different approach that Bristol-Myers Squibb Company took to dosing in a recent publication that plays along those lines. To sort of explain that.

Ed Milperant, I think, is an underappreciated story that was maybe negatively impacted by comparisons to a competitor asset. There's just a whole host of opportunities here that we see in the overall story this year. Hoping you might be able to help position some of those for us as we move through the balance of the year. Thanks so much.

Thanks for the question, Seamus. And agree with the overall sentiment. And maybe I will start and then I'll turn it over to Cristian Massacesi and Adam Lenkowsky and they can provide their perspectives. I think that when we look at what's particularly exciting for this year, I would highlight a few things.

First of all, we've got good growth just in the products that we have on the market today and I think that growth is going to continue into this year. As you know, we have a slew of data readouts coming this year, now just a few months away. For six products. And when you look at the actual number of phase threes, we could have over 10 Phase three data readouts this year alone with more coming in '27 and then another big slew of them coming in 2028. The things that I think stand out for me, you've already mentioned them actually.

The CELMoD program is beginning to bear fruit. We've already demonstrated PFS data for iverdemide. We'll see follow-up data on that with PFS this year. We've got admiral burn data coming.

We've got the Melvexian data and I agree also with your assessment of that where you know, I think we'll see the SSP data from a competitor today. But as I look at our profile, I think we have the potential to be best in class there. And of course, in AFib, we have the potential to be the only factor eleven oral therapy there which is obviously a big opportunity. But maybe I'll ask Cristian Massacesi and Adam Lenkowsky to quickly add anything to that.

So thank you, Christopher Boerner. Thank you, Seamus Fernandez for the question. Let me go a little bit more on the technical side because as you said, we have a very data-rich year. With 10 at least ten pivotal readouts I like to cluster them also in terms of area therapeutic areas.

In hematology, I think you mentioned Excalidari, adeptomide, we will have the PFS. MRD is already readout positive. We can share the data because, of course, the PFS was coming. We wanted to preserve the integrity of the study.

But we are very confident that what we have seen in MRD can translate also benefit in PFS. We will have the second cell monitor readout, MESI, and this is an add-on study. We had MEZI on top of KD versus KD. So considering the level of activity we have seen with this drug, I am confident on this first readout with the second CELMoD, a very important drug.

And then we have also Arlocell. Arlocell is a Phase II registrational study. The Phase III is ongoing. In myeloma.

In patient post BCMAs GPC5D CART. This is an entry with another card that is very, very relevant for us. So myeloma, rich here, I am very, very confident in what we have seen so far and what I'm expecting. Then we go into go as you said, Amiparantha.

Amiparantha I'm very happy because what I have seen is Phase III conducting and enrolling patients that are very similar to what we have seen in two. And you remember in Phase II, had a very good reduction of the risk of decline of FVC. Sixty percent in IPF and more than seventy percent in So IPF is coming this year, is closer. Actually, we'd be very, very closer compared to what we guided before.

So this is very exciting. Very high medical need. Maldexygen, I think Christopher Boerner already spoke about. Stroke has already been derisked in my view from the data we will see in few hours.

There is no reason to believe that we will have a different, if not better, outcome. And the AFib, the confidence is all there. Then I would not underestimate that program. The Adept program is coming by the end of the year as we guided.

We are on track. All of this is moving at pace. So as you said, four different therapeutic areas where we'll have a major readout and these are very transformative regimen. Adam Lenkowsky, you want to?

I think, and you covered it extremely well. Why don't we go to the next? Thank you. Thank you.

Our next question today comes from Christopher Schott at JPMorgan. Please go ahead.

Great. Thanks very much. Just two for me. First, just elaborate on Eliquis dynamics for 2026 contributing to growth this year.

Maybe just a bigger picture one on business development priorities. Just elaborate a little bit more terms of your focus right now. Is this more on deepening presence in existing therapeutic areas? Or maybe pursuing more corona-like kind of expansions into new spaces?

And maybe as part of that, I know as you just highlighted, you've got a lot of important readouts coming this year. Should we think about Bristol-Myers Squibb Company waiting to see how these programs pan out and that that might help guide where you wanna go with BD, or is that not a rate limiter for the company? Thank you. Thanks for the question, Christopher Schott.

I will start on the BD question. I'll turn it over to Adam Lenkowsky. So as was said earlier, BD continues to be a top priority. As you well know we have always sourced innovation both internally and externally.

And the good news here is that we're in a very strong position as you alluded to with the late-stage pipeline. We don't need to chase deals. That said, we're going to continue to be looking out for opportunities to add strength and depth to our portfolio. In terms of the opportunities we're looking for, we've got a lot of opportunity to continue to build depth across each of our areas.

So if an opportunity is in an area that we know well scientifically where we can add clinical or commercial value and ultimately deliver that value to patients the company and shareholders. We obviously have the financial ability and the muscle to. And so that's generally how we'll be approaching BD this year. And timing-wise, I think that obviously we're going to be opportunistic.

Adam Lenkowsky?

Christopher Schott, thanks for the question. Let me start by saying that we continue to see strong performance with Eliquis. And this performance will continue throughout 2026. We have approximately 75% anorex share in the U.S. And we will continue to grow that.

Now the broader pricing dynamics starting this year for Eliquis was the impetus for us to reevaluate our pricing strategy. And, of course, there's some pushes and pulls. Recall the IRA price was effectuated January 1, and this includes the removal of the Medicare Part D liability both in the initiation and in the catastrophic phase. We also finalized our $0 Medicaid agreement with administration and we took a step back and we're able to reassess our commercial contracting strategy as well.

The roughly 40% WAC reduction eliminates inflationary penalties or CPI penalties of statutory rebates that have been accumulating over many years for the brand. And taken together, the continued increase in Eliquis market share in the United States coupled with these net pricing changes they're gonna enable Eliquis to be an important driver of growth this year.

Great. Thank you, Adam Lenkowsky.

Rocco, let's go to the next question.

Yes, of course, absolutely. And our next question today comes from Michael Yee at UBS. Please go ahead.

Great. Thank you. Two questions. One on Milvexian and AFib.

Previously, you've suggested that there are lower blinded safety event rates bleeding, particularly. Can you just remind us how often that study is looked at? And whether that generally continues with DSMB safety looks across blinded rates into 2026 here and how you feel about that? And then second, just following up on the BD question, I know that you obviously want to focus on key strength areas.

Is metabolic obesity a fair question or a fair area that investors should be understanding of? And is that still an area that actually you would engage in? Thank you.

Thanks for the questions. Let me start with metabolics, and I'll turn it over to Cristian Massacesi. Look, metabolics is obviously an exciting area. You've seen it this week.

We continue to pay attention to the evolution of that market and of course the science. That said, we're really looking at opportunities to build breadth and depth in our existing therapeutic area. These are areas we obviously know well. We can assess the science and commercial opportunities, which is significantly important, particularly as we think more broadly.

And it's also an area the areas that we can best add value from a patient company and shareholder standpoint. So that's our primary focus. Cristian Massacesi?

So thank you, Michael Yee, for the question. As you know, we completed the enrollment in Librexia as a fibrillation study. We have more than 20,000 patients. And we well passed the point for instance in which oceanic atrial fibrillation study terminated by the DMC because of lack of efficacy.

And as you said, the DMC regularly continue to endorse the tire progression and this happened also very recently. They check efficacy and safety. We remain blinded to the study. What I can tell you is that recently and there is a lot of data that tell us what is the bleeding rates with Eliquis.

And in AFib study, it's a net to add maldexan helquis. And we remain blinded, but what the GMC is telling us and what we see in a blinded fashion in terms of bleeding rates, give us confidence that we are still very much on target to achieve the benefit that we hope showing that Eliquis and Murbexana similar in terms of efficacy, but that Malvexan can bring a benefit in reducing importantly the bleeding risks measured bleeding risk and also non-measured clinically relevant bleeding risks. These are we are fully on track on this and the study is coming this year.

Thank you, Cristian Massacesi. Next question please.

Absolutely. Our next question today comes from Courtney Breen with Bernstein. Please go ahead.

Hi, guys. Thanks so much for taking the question today. I just wanted to double click on Eliquis question as well as on cost savings in 2026. I know your intention is to take more cost savings in the 2026 period. And so it would be great if you can kind of perhaps characterize those relative to what you're able to achieve through the year in 2025?

And then on Eliquis, thanks for giving the details around kind of some of those 2026 dynamics. I think you made some additional comments on that '26 to '27 transition of a $1.5 to $2 billion further step down. Can you just help us understand kind of what is driving that primary change at that moment time relative to this new baseline on pricing that we've just spoken through now. So much.

Thanks for the question, Courtney Breen. I'll ask David Elkins to take both and go from there.

Yes. So on the cost savings program, as you saw this year, we've made really great progress against the $2 billion strategic productivity initiative. Achieving over $1 billion of that. And sitting here today, got really solid line of sight into the additional $1 billion which will be spread over 'twenty six and 'twenty seven.

So you'll continue to see a step down our expense base. What I'd also say is it's also enabled us to reinvest in growth drivers, some up and we did last year with Probensi as well as Camzyos but also with a couple of the deals that we did with Orbital Therapeutics. As well as FUMITAMAG, we'll be analyzing those costs here in 'twenty six, and we're still reducing our cost basis as a result of that.

Do you want to just hit on Eliquis dynamics this year and then you and David Elkins can speak to '26 to '27?

Yeah. So I spoke about the Eliquis dynamics, and as Courtney Breen said, around the pricing changes that took place effective January 1, including the removal of the Medicare Part D liability and the 40% WACC reduction. So we wanted to guide against 2026. David Elkins will talk about our decision not to guide for 2027, which had started, you know, when Christopher Boerner initially became CEO in a decision not to provide longer-term guidance. David Elkins, do you want to expound on that?

Yes, Courtney Breen, and thanks for your question. If you remember back in August 2024, when the IRA came out, there's a lot of questions about what that impact was. So we provided guidance at that point in time. We thought it was important just to update you on that 27%.

So what we said this year is that we expect Eliquis to grow 10%, 15%. And as you think about next year in my prepared remarks, I said that, you should expect a similar step down about 1.5% to $2 billion from $26,000,000,000 to $27,000,000,000 which is consistent with the step down consensus has now. So hopefully, that's helpful. And Courtney Breen, just a reminder, Chuck Triano here.

Remember, the EU patents largely expire late in 'twenty six, so that's going to be a factor in 'twenty seven that we'll see. As well in terms of driving the step down.

Operator, can we take the next question?

Absolutely. Our next question comes from Mohit Bansal with Wells Fargo. Please go ahead.

Great. Thank you very much for taking my question. I have a question on LPA1. So from the feedback we have received from some KOLs is that the talk toxicity burden that is associated with the existing standard of care, Combo therapy may be reserved for most severe patients. And for the widespread use of LPA one monotherapy, patients may still want to see some kind of efficacy benefit over existing therapies here.

I don't know how you're thinking about it, but would love to get your thoughts on, like, what it takes for a new therapy like LPA one to become a new standard of care either as a monotherapy or a combo therapy in this space. Thank you.

Thanks for the question, Mohit Bansal. Adam Lenkowsky? Mohit Bansal, thanks for the question. So IPF and are progressive pulmonary diseases and prognosis these diseases is not dissimilar to what we see with some metastatic cancer diagnosis.

In fact, there's less than fifty percent five-year overall survival rate. So there's significant need for newer therapies that provide greater and tolerability. What we're excited about with Admiralty which is our LPA1 that this is a potential first-in-class product that we believe could redefine the standard of care in pulmonary fibrosis. Offering improved efficacy and improved tolerability profile.

Remember, I know it works by slowing the progression and could actually potentially halt the progression of disease. And we look at the adverse event profile we're seeing low rates of GI tolerability, which has been a real challenge for some of the older therapies as well as some of newer therapies that are recently introduced to the market. To help manage their disease. In fact, about fifty percent of patients abandon treatment by twelve months.

We also see some newer agents, you know, have some formulations that may limit uptake. So we would expect to see Edmilpront used in combination and as a monotherapy similar to how we're studying the drug and we really look forward to the data readout in the second half of this year. Thanks, Adam Lenkowsky. Let's move to our next question please.

Thank you. And our next question today comes from Terence Flynn at Morgan Stanley. Please go ahead.

Hi. Thanks so much for taking the question. I just had two. One is just on the milvaxia and Afib study.

Cristian Massacesi, wondering if you can speak to what you view as a clinically meaningful delta versus Eliquis that would be enough to support broader payer coverage there. And then just David Elkins, on the guidance the math that we're doing suggests kind of mid-single-digit growth year over year on the growth portfolio, which includes Opdivo. Just wanna know that that we're in the right ballpark there. Thank you.

Thanks for the question, Terence Flynn. Maybe Cristian Massacesi and Adam Lenkowsky combined on Novaxin and then David Elkins.

Thank you, Terence Flynn, for the question. The study primary endpoint is showing non-inferiority versus Eliquis, that's apixaban. On efficacy. And you know, Terence Flynn, we selected those that is was very scrutinized and to balance activity, potential activity and, of course, bleeding risks.

This is why we are using one hundred milligram BID. It is a dose that much higher for instance that we use in stroke. Prevention. So I would say there is a possibility that of course, MELDEX can show a better outcome.

But the real and percent point is showing non-inferiority. Let's not forget about oceanic Afib actually did not was able to show that level of similar activity versus apixaban. Then after the non-inferiority will be met, we're to test the superiority for bleedings. So this is also where we want to show a clinically meaningful differentiation on the bleeding rates.

I don't give you the deltas and everything. Of course, we believe that if the study will be a target, it will be clinic seen as clinically meaningful. Adam Lenkowsky, you want to? Yes, Terence Flynn, thanks for the question.

So Mugaxin represents significant commercial opportunity, particularly in Afib. Afib a very large market and, you know, we believe that MobXion has the potential to replace first-generation DOACs. And this is a market that we know very well. Fear of bleeding continues to be the main reason why clinicians hold back from using factor tens in more patients.

Roughly forty percent of patients remain either untreated or undertreated leaving them at risk for a stroke. And, you know, they had significant concerns around bleeding. And so we know safety is important. We believe a differentiated bleeding profile will drive demand versus standard of care.

We've had a number of payer discussions already. That suggest that the potential of improved benefit-risk profile will be a strong value proposition, and we would also expect there to be an economic benefit of using Novaxin over Eliquis in terms of bleeding events. That are avoided. So we look forward to the data readout at the 2026. And we're confident this product has multibillion-dollar potential.

Yes. And Terence Flynn, you're absolutely right. In your math and thinking about the growth portfolio. We feel really good about the growth portfolio, mid-single-digit growth.

But also we have the risk of like a Red Sea and generics coming this year, which would impact that growth portfolio. But we feel really good about where we exited 2025 and about the prospects heading into '26 now. Right. Thanks, David Elkins.

Let's take our next question please.

Thank you. And our next question today comes from Jeff Meacham from Citi. Please go ahead.

Great. Morning, everyone. Thanks so much for the question. I have a couple.

So one for Adam Lenkowsky, I guess, on CoBINCI. There's a lot of excitement earlier last year, you just given its mechanism and lack of innovation in the category, but we really haven't seen an inflection point in sales. I guess, is there a bottleneck in access that you really have to still work through? I'm just trying to figure out the steps to see sequential acceleration.

And then on PUMITAMIG, I guess for maybe for Christopher Boerner or Cristian Massacesi, is there a dataset, a tipping point maybe of data that you wanna see before you really scale up the Phase III investment? And just given its foundational mechanism, what's the upper end of either Phase III studies or tumor types that you ultimately have a capacity for the drug? Thank you. We'll start with Adam Lenkowsky and then Cristian Massacesi can handle the question.

Great. Thank you, Jeff Meacham. So we're pleased with the progress that we made in Coventry's first full year on the market. In fact, Coventry delivered over 100,000 TRxs since launch, and that surpassed all relevant schizophrenia analogs.

We have very strong access, virtually 100% access across Medicaid and Medicare and now we're approaching 70% commercial access. So that is certainly not a bottleneck. You know, we made good progress in Q4 as you're able to see with an acceleration of NRxs as well as increases in both new NRP trialists after our full field force expansion within place in both the community and the hospitals. We see continued opportunity for growth in schizophrenia.

As we stated, we're confident in our ability to deliver continued steady growth and new indications are going to be the driver of inflections there. But hear from physicians, the feedback continue to remain positive. We are making very good progress with adding the number of trialists, which continue to grow steadily. And importantly, what we have seen is that those physicians who've had a positive experience with Coventry have shown an increased propensity to repeat prescribing.

So this year, we'll present several new Phase four studies including a switch study later on in the quarter, which is the top question that we get from physicians on how to switch from a D2 over to Cobenfi. We'll have real-world data as well to support that and we're increasing investment in peer to. So taken together, we are making good progress. And based on all the leading indicators we're seeing, we believe Coventry has the potential to become a leading treatment in schizophrenia over time and we're confident could be a big drug for the company.

Thanks for the question, Jeff Meacham. The let me break down your question in. The first thing is the confidence. First of all, we have data sets in triple negative and in small cell lung cancer, showing that the drug is active.

And there are also very large data sets from competitive assets that reinforce the message. The second thing is more on these are two very well clinically validated targets. PD-one, PDL-one and the VEGF. And you know that when you deliver mechanism through bispecifics sometimes you increase the selectivity and this can be even more powerful than just delivering the two mechanism into two different drugs.

Then when you look, we are actually already scaled up the development of this drug. The confidence is very high. We believe the strategy is very simple. We want to replace and then we want to expand.

We want to replace where PD-one, PD L1 inhibitors are playing today in those indications through this bispecific. And then we want to expand because we believe that bringing VEGF on top of PD L1 inhibition so we can also tackle some of the indication where PD-one, PD L1 inhibitors are now working well enough or not at all. So this is the reason why we already have started or are in flight to start seven pivotal studies across multiple indications. And there is an eighth one that we announced in head and neck.

And when you look at the indication, course, there is a concentration in small cell lung cancer, very important indication, but this goes beyond gastric colon head and neck, breast. So this is a program that as a top priority in oncology and we represent the backbone of our portfolio. The next wave will be to novel novel and that will be the next wave of studies where we will continue to improve on regimens that we are creating today.

Excellent. Thanks, Cristian Massacesi. Let's move to the next question please.

Thank you. And our next question today comes from Asad Haider with Goldman Sachs. Please go ahead.

Great. Thanks for taking the question and congrats on the quarter. Most of my questions have been answered, but maybe one for Adam Lenkowsky. Just any update on how the Opdivo subQ formulation launch is progressing?

We've had four quarters on the market now, two with the J code. Do you believe you're still on track for the 30% to 40% patient conversion by 2028? And any color on the types of patients who are utilizing it would be helpful. Thank you.

Great. Thanks, Asad Haider. So we're very pleased with the Juvantik launch performance in its first full year on the market. We're encouraged as we're seeing use across multiple tumor types, we're seeing uptake across monotherapy indications as well as in the combination setting.

So patients who are treated for RCC, GI, melanoma. As you said, we did receive our permanent J code last July, which eased the reimbursement process for physicians. And post that, we've seen a nice acceleration of new accounts adopting. We're focused on continuing to drive depth and breadth of account conversion and reinforcing the benefits that we know are there for both practices and for patients.

And we're tracking well against our expectations and remain very confident in our expectation that physicians will convert 30% to 40% of the IV business ahead of the LOE. So we're pleased to performance and what this means for patients and for physicians.

Right. Thanks, Adam Lenkowsky. Let's go to the next question, please.

And our next question today comes from David Risinger with Leerink Partners. Please go ahead.

Yes, thanks very much. So I have two questions please. First, with respect to Edinopuran, could you just talk about the hypotension risk and how you would contextualize that for us? And then second, would be helpful to just better understand what is in the guidance and what you're assuming for generic competition.

So for Eliquis, could you just talk us through when you're expecting generic entry in major markets ex U.S? In '26 and '27. And then, for Orencia, how many players do you anticipate launching and when? Thanks so much.

Thanks for the question. I'll ask Cristian Massacesi to start and then David Elkins.

Thanks, David Risinger for the question. The hypotension and syncope episode was one of the tolerability risks that we had with ameprantin in the Phase two. But what I can tell you that actually in the context of the Phase three, this is going very well. Let give you a little bit more context.

When we run the Phase two, we tested two doses at thirty and sixty milligram. And of course, there was a dose relation outcome in terms of efficacy and also safety. But then when we completed the study, we have seen that the risk of syncope was well managed. And actually we decided to because there was a dose evaluation on efficacy, we decided to introduce in the Phase three one hundred and twenty milligram.

And actually we are currently running the Phase three studies IPF and with one and twenty and sixty. And one hundred twenty there was a run-in just to assess safety and the risk of hypertension, the DMC allowed us to go in Phase three and in a blinded we didn't see any rate that raised any concern. So this is definitely associated to the profile of the drug is very well managed even when you go with a higher dose. That of course can translate it to a better efficacy.

Yes. Just to add, Cristian Massacesi, what we're hearing from physicians is that this is a very manageable side effect. And when you look at the totality of the drug, not only have we seen exciting results around FTC, I talked about earlier, when you look at the the rates of GI toxicity that have really plagued some of the assets that are out there today. As well as some of the newer products that are coming to the market that have significant costs, cough issues or dyspnea issues that can lead to, you know, significant exacerbations.

I think, you know, we have an opportunity to truly be a best-in-class product both from an efficacy and a safety standpoint.

Yes. And the question on Eliquis, talked about it in total that 1.5 to $2 billion step down as we go into 2016 that is driven by generic entries we're assuming are going to happen. It's really spread throughout. It's a country-by-country basis on how that goes in.

We're in litigation. We're in appeals in several of those markets. So we have to see how that plays out. But we've made broad-based assumptions about generic entry.

Yes. And think the last part of the question, David Risinger, was around So Orencia continues to perform well with great cash flow for the organization. As far as a biosimilar for Orencia, we do know that Doctor. Reddy Labs has posted a, you know, opportunity to to file their manufacturing facility is out of India and we've had this product now since 2006. And we recognize the challenges that it takes to manufacture product like Orencia.

And so, you know, we do expect to see continued cash flow from this important product for patients.

And David Risinger, would just underscore in the EU, country by country for sure. The bigger countries are clustered around late in the year, in the November timeframe late in the year. And with that, can we go to our next question, please?

Absolutely. Our next question today comes from David Amsellem with Piper Sandler. Please go ahead.

Hey, thanks. So wanted to ask about Combemfi and a bigger picture question there. A number of companies developing their own m one, m fours, and in some cases without a peripherally acting anticholinergic. So I wonder how you think those agents down the road could impact CoBIMP growth, if at all?

That's number one. And then number two is you just talk more to how big of a priority is it to add a late-stage or commercial-ready psychiatry-focused asset or assets where you could leverage the commercial infrastructure that you've built to support Kibimpe. Again, how big of a priority? How aggressive do you wanna be here?

Thank you.

Well, let me start on the business development question, then I'll ask Adam Lenkowsky and Cristian Massacesi to address the specifics of the Coventry pipeline question or competitive question. So from a business development standpoint, as I said earlier, our focus is on continuing to build out breadth and depth in each of our therapeutic areas. Obviously, we've shown willingness to do business development to build out our presence in neuroscience and I think you can expect that if there are attractive opportunities where the science is compelling and where the financials allow us to add value to the company and ultimately to shareholders in the neuro space, we would certainly be looking at it.

Adam Lenkowsky?

Thanks for the question. When we're doing the work for Corona, we were really excited by the novel mechanism of action. Not just the fact that it was working on muscarinic, but the fact that the m one, m four component of that, which we saw brings an opportunity for increased and improved cognitive benefit and schizophrenia as well as negative symptoms. And we're seeing that in the market today.

Additionally, when you look at the incredible lifecycle management program that we have in place with significant number of studies that are ongoing in Alzheimer's disease in Alzheimer's disease psychosis, Alzheimer's disease cognition as well as agitation coupled with bipolar disorder, this has the opportunity to be a very significant drug in the neuropsychiatric space. And we also have a very significant head start on other competitors coming. And I'll turn it to Cristian Massacesi to talk about Coventry and also the pipeline as well that we have from the Kuna acquisition. So David Amsellem, you raise an important point.

There are many there is there are M4 agonist, there are M4 PAM positive allosteric modulators. You have other M1, M4 that are emerging. First of all, we are ahead of everybody else. This is the first point.

The second is we still don't know how M4 agonist or M4 pump can can play out versus an M1, M4 inhibitor like Kuventis. And we don't still don't know if you change your peripheral radical energetic drug how this can impact brain penetration and additional the control of some of the cholinergic symptoms. We believe that Covenxi with exanomelin and Trospion has the right approach. As Adam Lenkowsky said, we have a very rich pipeline from corona from our internal research that, of course, keep investigating these mechanisms.

And we will disclose at the right time how these programs are progressing. And we are focusing very much on these receptors. And of course, we have assets that go beyond that. Because some of them are as to control symptoms in Alzheimer, others are disease modifier assets.

So our Alzheimer pipeline is very rich and we are very excited about it actually.

Thank you, Cristian Massacesi. Next question, please.

Thank you. And our next question today comes from Jason Gerberry with Bank of America. Please go ahead.

Hey, guys. Thanks for squeezing me in. So just for me on Novvexime, can you remind us why you opted not to enrich in the SSP trial for atherosclerosis? And do you think that in any way poses a risk in terms of reading across from the positive efficacy result from the buyer data later later today in SSP?

Then my second question is just know, as we look at the CELMoDs and and the second line plus refractory multiple myeloma space. It's obviously getting increasingly complicated with recent data from the bispecifics. And so I'm just kinda curious how you guys are thinking about, you know, the relative positioning here if if data are confirmatory on phase three. Obviously, there's a lot to be kind of sussed out with your data, but do do you see these as agents that maybe you know, appeal more to community providers, more as, like, third, fourth line drugs, or do you think they get used earlier?

Just any color on how you see it kind of positioning within an increasingly complicated space? Well, me start and I'm going to ask Adam Lenkowsky and then Christopher Boerner can chime in on your Milvaxian question. As we look at Selmab program generally, we're very excited about the data that we've already seen. And about the commercial potential, particularly in light of some of changes taking place in that landscape.

But Adam Lenkowsky, do you want elaborate?

Thanks for the question. Just building on Christopher Boerner's comment. We've got good momentum coming off the ASH meeting last year, and we see excitement building around our overall CELMoD portfolio. Iverdamide vizigimod and glulcademide.

Hematology. And this is a market, Jason Gerberry, that we know very well. This is a competitive market. It's a fragmented market.

There remains a need for more effective and safe treatment options that can address the majority of patients, particularly those that are treated in the community setting. And roughly seventy percent to eighty percent of patients treated in the community. Now while Rev and POM based combinations are the backbone of treatment across early lines of multiple myeloma. There's an opportunity to improve upon their depth and durability is an opportunity to improve on their tolerability and we expect iverdemide will provide that balance of high potency manageable toxicity profile, combinability with anti CD38 with the convenience of an oral treatment.

We continue to hear positive feedback from physicians. So our goal is to make both IBRA and Mezi foundational in multiple myeloma, replacing image in earlier lines of treatment. So this is going to be for iveratomized, a second line product, large used in the community in combination with daratumumab. Ultimately, longer term, we believe that these can serve as partners for TCEs and cell therapy.

So we'll be studying that there. We presented data with Pfizer's TCE at ASH. So once approved, we expect good adoption over time in the community in second line as most patients just don't have access to cell therapies or bispecifics due to safety and accessibility challenges. So our teams are readying for the launch of iverteimide.

We know the work that we need to do to establish both iver and Mezi in this competitive market and we're excited to bring them to patients.

So Jason Gerberry, thank you. It's very good technical question you're asking. But let me help you to clarify. Some of the eligibility criteria set from the stroke study that Bayer is running and our Librexa stroke studies can be different.

But when you look, we didn't disclose our baseline patient and disease characteristics. Like they did and in few hours we will see they also did the. But I can tell you that the two studies are very similar in patient population. When you look at the events that are causing the stroke, you have three categories, large artery atherosclerosis, these are events that are coming faster.

You have events that are coming from lacunar strokes. These are when the occlusion or small arteries in the brain. And then strokes that are coming from embolic events that you don't know the source unknown source. So this will not be very different between the two studies.

And we believe that there is nothing and by the way, we control the number of events coming from La Cuner. So we will not have a disproportion of that because it's capped. In terms of event. So this give us confidence that the two studies and the way we run our study at least is the right way.

Thank you, Cristian Massacesi. Next question please.

Thank you. And our next question today comes from Evan Seigerman at BMO Capital Markets. Please go ahead.

Malcolm Hoffman on for Evan Seigerman. Thanks for taking our question. I wanted to ask two commercial questions real quick. So first on OptoLeg, in the fourth quarter, we saw in The U.

S. A particularly strong growth even relative to maybe prior years in 2024. Can you talk about some of the dynamics that may be contributing here? Obviously, the standard of care on melanoma, but are there particular physician engagement efforts that are contributing in The U. And then secondarily on Reblozol, I know highly penetrated in MDS anemia.

Can you just help contextualize how much more room there is for growth in this indication? Thanks.

Yes, thanks for the question. So Omtolag has become a standard of care in first-line metastatic melanoma in The United States. Oplalag is now approaching four years post-launch and has over 30% market share. In fact, you look at the totality of Bristol-Myers Squibb Company market share in metastatic melanoma, we're now over 65%.

So our objective is to continue to expand our share. It's still roughly fifteen percent of patients that continue on PD-one monotherapy. So there's an opportunity there to source that business this year. Additionally, we started to launch internationally in markets like Australia, UK, France, that will contribute to growth in 2026. We also expect an all-commerce indication in Europe in Q2 which will drive significant growth internationally.

So we see opportunities to increase sales of Ophalaag in The U. S. And as well as ex U. S.

With broader label. As far as Reblovil, as you mentioned, Reblozyl delivered continued strong growth. As you heard from both David Elkins and Christopher Boerner, Rebazil is now annualizing over $2 billion of sales worldwide. We're continuing to drive demand across first-line RS positive and first-line RS negative patients.

We expect to see continued strong growth, particularly in the RS negative patients where there's an opportunity for growth. We saw a very rapid uptake initially post command in RS positive. And RS negative provides the greatest opportunity for growth in The United States. Outside of The US, in many markets, we're just starting to launch and get reimbursed in first line.

So overall, we see continued solid growth for Reblozyl in first line this year and we expect strong performance.

Thanks, Adam Lenkowsky. And operator, we'll have one more question then Christopher Boerner will make a brief closing. Thank you.

Thank you. And our final question today comes from Stephen Scala with TD Cowen. Please go ahead.

Thank you so much and apologies. This is an Eliquis question. But I don't think this product has grown double-digit in several years but then will in 2026. And it's still not absolutely clear why there will be a step down in 'twenty seven. If the 2026 is boosted by a higher commercial price, why won't that also boost 2027?

I understand about OUS patent expirations, but OUS in its totality is only $4 billion and I think some patents have been off for years. I would I think it's striking for a product to go from double-digit in one year to $1 billion declines in the following. So it seems like what you're really saying is U. S.

Prices coming down in twenty seven point two it's not clear why. And related to this, how did the contributing 7,000,000,000 of Eliquis API to the US government impact the P and L? Thank you.

Great, Stephen Scala. Thanks for the question. Just at a higher level. Number one, we continue to see strong demand performance with Eliquis and that's going to continue in twenty twenty six.

When you look at the price reduction that took place in The United States, that will eliminate the inflationary penalties, CPI penalties of the rebates this year and into next year. When we look at in totality, you're right. Roughly 70% of the Eliquis business is in The US. This is a very large brand.

And so we expect in November that we will lose exclusivity in Europe, and we would expect rapid and steep decline like we have seen with other small molecules outside of The US. And so that's why we would expect to see that step down in 2027. And just on your question on the strategic reserve, that's not a material impact on the overall business, just given the magnitude of the business as well as just amount of product that will be provided in that reserve. So no impact there. So thanks for the questions and maybe just in conclusion, we've spent as we've discussed on these calls for the last number of quarters significant time on execution as a company across functions.

And I think what you see in the numbers we put up today is that we're doing what we said we would do. We've become much more focused. We strengthen, execute, across, all of the relevant functions in the organization. We've built a growth portfolio that has very strong momentum coming into the year.

We have a pipeline as has been discussed on this call of differentiated assets that is now within months of meaningful data readout. And finally, we've continued to strengthen the company financially and that of course gives us strategic flexibility not only return capital to shareholders, but continue to add substrate for growth. I'm incredibly proud of the strong foundation we have coming into this year, which we couldn't have contributed to without the commitment and dedication of my colleagues at Bristol-Myers Squibb Company. So thank you all for joining us today.

As always, the team is going to be available for any follow-ups. Have a great rest of the day.

Thank you. That concludes today's conference call. We thank you all attending today's presentation. You may now disconnect your lines and have a wonderful day.