Bristol-Myers Squibb Q4 2024 Earnings Report

Bristol-Myers Squibb EPS Results

• Actual EPS: $1.67
• Consensus EPS: $1.47
• Beat/Miss: Beat by +$0.20
• One Year Ago EPS: N/A

Bristol-Myers Squibb Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $11.57 billion
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Bristol-Myers Squibb Announcement Details

• Quarter: Q4 2024
• Date: 2/6/2025
• Time: Before Market Opens

The Bristol-Myers Squibb (NYSE:BMY) Company is a leading global biopharmaceutical company with a long and impressive history of innovating and developing medicines that improve the lives of patients around the world. Founded in 1887 when William McLaren Bristol and John Ripley Myers purchased the Clinton Pharmaceutical Company, the company was initially named Bristol, Myers and Company. Its first nationally recognized product, Sal Hepatica, was released in the 1890s.

Bristol Myers-Squibb offers chemically synthesized drugs and biologics administered through injections or infusions to patients. The company's pharmaceutical portfolio includes a large number of well-known products. BMS's primary research and development sites are in New Jersey, California, Spain, Massachusetts, New York, Belgium, Japan, India and Massachusetts. The company's products sell to wholesalers and distributors around the world.

Bristol Myers-Squibb has a robust pipeline of investigational medicines in its pipeline. In addition, the company has established strategic collaborations and partnerships with various companies, successfully launching new products. These partnerships and investments generate portions of the company's revenue. 

Bristol Myers-Squibb has acquired several companies over the years, including Medarex in 2009, ZymoGenetics in 2010, Inhibitex Inc. in 2012, Amylin Pharmaceuticals in 2012, iPierian in 2014, Flexus Biosciences in 2015, Cardioxyl in 2015, Padlock Therapeutics in 2016, Cormorant Pharmaceuticals in 2017, IFM Therapeutics in 2017, Celgene in 2019, Otezla in 2019, Forbius in 2020, MyoKardia in 2020 and Turning Point Therapeutics in 2022.

In 2005, the company divested individual consumer products and its subsequent consumer products businesses. In December 2014, the company received FDA approval for its cancer drug, Opdivo, used to treat skin cancers that do not respond to drug therapies. In 2019, the company divested its consumer health business, UPSA, to Taisho. 

The company has also faced several scandals, lawsuits and investigations over the years, the biggest of which is the ongoing $1 billion lawsuit from Guatemala for the company's role in a 1940s experiment that infected hundreds with syphilis. In 2001 BMS faced an accounting scandal that resulted in a restatement of revenues from 1999 to 2001. In 2002, BMS faced a lawsuit based on illegally maintaining a monopoly on Taxol, a chemotherapy medication. The former head of the pharma group and the ex-CFO were indicted for federal securities violations in 2005. In July of 2006, an FBI raid on the company's corporate offices revealed that the company took steps to delay the release of a generic version of one of its drugs.  

BMS began a significant restructuring in 2009, focusing on the pharmaceutical business and biologic products, productivity initiatives and cost-cutting. The U.S. attorney forced the company into oversight and appointed a monitor as part of a deferred prosecution agreement. Lou Schmukler joined Bristol-Myers Squibb in 2010 as global product development and design president. 

In 2013, Forbes magazine ranked the company as the drug company of the year. Dr. Giovanni Caforio took the reigns as CEO in 2015. In 2017, reports began to surface that activist investor Carl Icahn took a stake in the company, widely seen as a signal for a potential future takeover. 

As Bristol-Myers Squibb continues to experience success and growth, the company is committed to delivering innovative treatments to patients and staying ahead of the curve in the biopharmaceutical industry. With its focus on research and development and a long and rich history of delivering innovative medicines, BMS offers an excellent long-term investment opportunity.

Bristol-Myers Squibb Q4 2025 Earnings Call Transcript

Presentation

[Operator]

Welcome to the Bristol-Myers Squib 4th-Quarter 2024 Earnings Conference Call. All participants will be in 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 to. 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, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thank you, and good morning, everyone. We appreciate you joining our 4th-quarter 2024 earnings call. Joining me this morning with prepared remarks are Chris Berner, our Board Chair and Chief Executive Officer; and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Linkowski, our Chief Commercialization Officer; and Sumit, our Chief Medical Officer and Head of Global Drug Development. Earlier this morning, we posted our quarterly slide presentation to bms.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll remind everybody that during this call, we will make statements about the company's future plans and prospects that constitute forward-looking statements.

Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date, and we specifically disclaim any obligation to update forward-looking statements even if our estimates change.

We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com. Finally, unless otherwise stated, all comparisons are made from the same-period in 2023 and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign-exchange. All references to our P&L are on a non-GAAP basis.

And with that, I'll hand it over to Chris.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thank you, Chuck, and thank you all for joining us this morning. As we'll discuss today, 2024 was a year of good execution across multiple fronts. Importantly, our performance last year establishes a solid foundation to continue our multi-year journey to achieve top-tier sustainable growth by the end-of-the decade. I will begin with some comments on our 4th-quarter and full-year accomplishments. Then I will speak to the promise we see with Kobinfi and the steady cadence of clinical data catalysts that will begin this year, further defining our future growth potential. I will end with an overview of our 2025 guidance.

Starting on Slide 4, we closed 2024 with strong 4th-quarter performance, reflecting another quarter of double-digit percentage increase for our growth portfolio. In addition, we saw strong performance across key parts of the company and achieved notable commercial and R&D milestones. Looking at the full-year, let's turn to Slide 5. I'm pleased with the progress we have made executing on our multi-year plan. For the year, the growth portfolio delivered double-digit revenue growth led by Breyanzi, Camzyos, Reblozyl and. In the latter part of the year, we reestablished our presence in neuroscience with the US approval and launch of, which is the first novel mechanism for the treatment of schizophrenia in decades.

We also received US approval of Opdivo in late December. This new subcutaneous formulation of nivolumab will help extend the reach and impact of our immuno-oncology franchise to patients into the next decade. Throughout 2024, operational excellence and financial discipline were top priorities for us. As part of this effort, we reallocated significant spend towards high-potential growth opportunities, achieving most of our targeted $1.5 billion in savings. We expect to capture the remainder this year. Additionally, we put considerable focus in 2024 on improving R&D productivity.

As a result, we have been able to accelerate several programs in our late-stage pipeline. Notable examples include CAMZYOS, where we completed enrollment in the Odyssey non-obstructive HCM study six months earlier-than-expected and now anticipate top-line results next quarter. With, the ADEPT-2 study in Alzheimer's disease psychosis is expected to have a top-line readout in the second-half of this year versus our original expectation of 2026. This is due to our focus on accelerating patient recruitment following the acquisition of Karuna. And with our ibertomide trial in relapsed/refractory multiple myeloma, enrollment is complete and we have an opportunity for a data readout this year also ahead of schedule due to the recent addition of MRD as a co-primary endpoint.

Looking ahead, we will continue to sharpen our focus on operational excellence. You saw the early steps of this strategy last year. As a continuation of that, we are taking deliberate steps to become a leaner, more focused company and have identified an additional $2 billion in savings. We expect approximately $1 billion of these savings to be realized this year and the remainder by the end of 2027. David will provide more details shortly. These actions are consistent with our strategy of investing in our growth portfolio and promising areas of science while maintaining financial discipline.

As I've said, this is a journey, but we're already seeing progress. I'm confident the actions we are taking are the right ones that will further advance our long-term sustainable growth strategy. Turning to Slide 6. The US approval of in schizophrenia was an important achievement in 2024 and the launch is off to a great start. While we're focused on delivering on the schizophrenia indication today, we see the potential for additional benefit to patients and have made strategic investments in a broad clinical development program. We expect to have important data readout starting this year and every year thereafter for the remainder of the decade.

This year, we're initiating seven Phase-3 studies across three indications, Alzheimer's disease agitation, Alzheimer's disease cognition and bipolar 1 disorder. And next year, we plan to begin Phase-3 studies in autism spectrum disorder irritability. The significant ramp-up in spending on illustrates our focus on continuing to invest behind key growth drivers while simultaneously maintaining financial discipline. Moving to Slide 7, we are entering a data-rich period with multiple catalysts over the next 24 months across a significant number of assets. In 2025, we have multiple important registrational catalysts, as you can see on this slide, including several that I already mentioned, as well as the ARISE study in adjunctive schizophrenia.

Then in 2026, we expect to have registrational data for numerous potential first and/or best-in-class medicines, including Milvexian in acute coronary syndrome and secondary stroke prevention, in idiopathic pulmonary fibrosis and in multiple myeloma. We also expect to have registrational data for or GPRC5D, CAR-T in multiple myeloma and for in GEP nets. We believe these data readouts will further derisk the pipeline and provide meaningful insight into the future growth profile of the company. Now let me give you an overview of our 2025 guidance and how we see this year playing out on Slide 8.

In terms of the top-line, we estimate revenue to be approximately $45.5 billion, reflecting, as expected, the near-term impact of generics across multiple products and the continued strength of our growth portfolio. As it relates to the bottom-line, we expect our 2025 non-GAAP earnings per share to be in the range of $6.55 to $6.85. This reflects the expanded savings program I mentioned earlier. David will provide more details on our guidance. Finally, turning to Slide nine. BMS is evolving into a fundamentally different company with a clear multi-year plan, strong execution and an accelerating pipeline. We now have a younger and more diversified growth portfolio. This includes Cobinfi, which has the potential to be a significant contributor to growth over the coming years.

We have a multitude of important data readouts over the next 24 months with the potential to launch 10 or more new medicines and pursue over 30 indication expansion opportunities over the next five years and we remain focused on the therapeutic areas where we have a long track-record of success and delivering transformational medicines to patients. We are confident in the steps we are taking to reshape BMS and by the end-of-the decade, we expect to have a transformed portfolio of marketed products driving top-tier sustainable growth. Now, I'll turn it over to David.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

Thank you, Chris, and good morning, everyone. I will begin my review of our 2024 financial results, focusing on our 4th-quarter performance. I will follow-up with the introduction of our non-GAAP financial guidance for 2025 and some important considerations to help you better understand our financial outlook for this year. Our performance in 2024 is marked by focused execution on driving top-line growth, generating strong cash-flow and managing our cost structure.

We have entered 2025 with a stronger foundation to deliver on our long-term growth strategy. Starting with Slide 11, sales in the 4th-quarter grew 9% to approximately $12.3 billion, driven by volume growth across the portfolio and higher inventory levels in the market. Our growth portfolio delivered another strong quarter with sales up 23% and represented slightly more than half of our revenue. Key brands like Rebazel, Breyanzi, and all achieved significant growth.

Within the legacy portfolio, higher sales of Eliquis were offset by the expected impact of increased generic volumes across several other brands, including Revlimid, Abraxane, and Pomelist. Overall, our performance in the 4th-quarter capped off a very good year for our company, making progress in-building a foundation for long-term sustainable growth. Turning to product performance on Slide 12, starting with oncology. Opdivo delivered solid growth in the 4th-quarter, primarily due to higher-volume. In 2025, we are focused on conversion and Educating the US market on the benefits of Opdivo, and we expect low single-digit growth for this product and Opdivo taken together. With Opdelag, we delivered another quarter of double-digit growth driven by demand in the US where it remains the standard-of-care in first-line melanoma. Ex-US sales benefited from uptake in newly-launched markets. Moving to cardiovascular on Slide 13, Eliquis delivered over $3 billion in 4th-quarter sales. US sales grew 19%, benefiting primarily from continued strong demand and the typical inventory build. Importantly, as you think about the impact to Eliquis from Medicare Part-D redesign, Q1 US sales growth will be tempered sequentially due to the implementation of the 10% manufacturer responsibility in the initial coverage phase. The remaining quarters of 2025 should steadily increase, particularly in the second-half of the year due to the elimination of the coverage gap. Turning to Camzyos, sales in the 4th-quarter more than doubled, benefiting from higher demand and a large inventory build. As a standard-of-care and obstructive HCM, Camzyos continued to show strong momentum as evidenced by the approximate 1,300 new patients added to commercial drug in the 4th-quarter. Additionally, we recently received a label update for Camzyos in Europe to ease the echo monitoring requirements in the maintenance setting for obstructive HCM. Importantly, we are pleased to announce today that we have a PDUFA date in April for a similar easing of the REMS echo monitoring requirements in the US let's turn to hematology on Slide 14. Delivered more than 70% growth, reflecting solid uptick across first and second-line MDS associated anemia patients. Sales in the US benefited from demand and included one-time gross-to-net benefit. Outside the US, Rebazel sales more than doubled, driven by demand across newly-launched markets in Europe and a strong launch in Japan. In-cell therapy, Breyanzi's 4th-quarter sales more than doubled, driven by its best-in-class profile and strong demand growth across all its approved indications. Now moving to immunology on Slide 15. Global sales of Sotyktu grew more than 30%. US sales benefited from higher demand, tempered by gross-to-net impacts from higher rebates associated with expanded access coverage. Starting in 2025, we further improved our access position with 80% of covered lives having zero-step edits, which will help us drive demand growth. As a result of this improved access position, however, we expect additional headwinds from higher rebates, notably across the immunology franchise. Regarding Sotyktu specifically, this will temper our reported sales in the first-half of the year until demand volume can offset these impacts. I will wrap-up reviewing our performance for the quarter on Slide 16 with Neuroscience and. Sales in the 4th-quarter were approximately $10 million and represent roughly two months of sales and initial stocking, and we've seen strong prescription uptake during these early months of launch. Feedback from both patients and physicians has been favorable, highlighting the benefits of differentiated efficacy and safety profile. Let's now move to the P&L on Slide 17. As expected, gross margin declined about 240 basis-points in the 4th-quarter, driven primarily by-product mix. Excluding in-process R&D, operating expenses increased approximately 8%, largely driven by R&D investments, partially offset by our ongoing cost-savings program. Regarding our operating expenses, we made significant progress during 2024 against our $1.5 billion strategic productivity initiative. As of the end-of-the 4th-quarter, we realized approximately $1.1 billion in savings and expect the remaining $400 million to be realized in 2025. Our effective tax-rate for the quarter was 19.9% compared to 14.9% in the prior year, primarily driven by earnings mix. For the full-year, excluding in-process R&D charges, our effective tax-rate was 18%. Overall, diluted earnings per share were $1.67 for the quarter and full-year diluted earnings per share came in at $1.15. Turning to the balance sheet and capital allocation highlights on Slide 18. Our financial position remains strong with approximately $11.2 billion in cash equivalents and marketable securities as of December 31. We generated strong cash-flow from operations of approximately $4.4 billion in the 4th-quarter. In terms of capital allocation, we continue to ensure we employ a strategic and balanced approach. Business development remains a priority as does our plan to pay-down debt. As of the end of 2024, we have repaid approximately $6 billion of the $10 billion of debt we committed to pay-down relative to our, 31 March 2024 balance. Our capital allocation priorities also include returning cash to shareholders through a commitment to the dividend. 2025 marks our 93rd consecutive year of dividend payments. On Slide 19, I'll provide more detail on our expanded strategic productivity initiative that Chris mentioned earlier. Building on the work we did to capture cost-savings last year, we identified additional opportunities to streamline operations, further leverage technology and drive greater efficiency in our ways of working. As a result, we expanded the existing program to include approximately $2 billion of incremental run-rate operating expense savings with approximately $1 billion to be achieved in 2025 and the remainder by the end of 2027. Under this expanded initiative, savings will be driven by changes in organizational design and efforts to enhance operational efficiency, with each accounting for roughly 50% of the targeted savings. Within organizational design, we will continue to optimize and streamline our workforce to better align with the future needs of the business. To further optimize resources and enhance productivity, we will drive operational efficiencies across multiple areas of the business. In contrast to the initial $1.5 billion cost-savings program where savings were mainly reinvested, this expanded program will see the incremental $2 billion in savings drop to the bottom-line. Overall, our focus is to become a leaner, more efficient company while investing behind our growth portfolio and promising areas of science. With that in mind, let me walk you through our non-GAAP 2025 guidance on Slide 20, starting with revenue. As Chris said earlier, we estimate revenue in 2025 to be approximately $45.5 billion, primarily reflecting the near-term impact of generics across multiple products and the continued strength of our growth portfolio. We expect an 18% to 20% decline in the legacy portfolio due to the stacking of LOEs and anticipated headwinds from foreign-exchange of approximately $500 million. This will be partially offset by higher revenue and continued strong performance of our key growth brands. Now continuing with our 2025 guidance for certain P&L line items, we expect our gross margin to be approximately 72%, which reflects the impact of product mix. Excluding in-process R&D, we expect total operating expenses to show a meaningful decline to approximately $16 billion, driven by the expanded cost-savings program I just mentioned, we anticipate our overall expenses to be more evenly phased throughout the year. Operating margin is expected to be approximately 37% for 2025. We're expecting OI&E income of approximately $30 million and 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 approximately $6.55 to $6.85. Before closing, let me provide some insight regarding our expected quarterly progression of revenue for 2025. As it relates to quarterly phasing, we expect the first-quarter to be impacted by the typical inventory destocking we see each year following the build-in Q4, as well as the additional gross-to-net pressures from Medicare Part-D redesign, which will be accentuated within Eliquis. As I said earlier, we expect Eliquis revenue for the remaining quarters of 2025 to steadily increase, particularly in the second-half. As a result of this, we expect the legacy portfolio to decline approximately 10% to 12% on a sequential basis, reflecting these dynamics and continued generic impacts as previously communicated. However, on a total company basis, we expect the inventory and gross-to-net dynamics to normalize beginning in Q2 with second-half revenues to be higher than the first-half of the year. In closing, our strong performance in 2024 has strengthened our confidence in our ability to deliver long-term value for our patients and shareholders. We remain focused on executing our growth strategy and rightsizing our cost structure. We also look-forward to multiple data catalysts, which will accelerate over the next 24 months and will derisk our pipeline and provide more certainty on the future shape of our company. And with that, I'll now turn the call-back over to Chuck for Q&A.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thanks, David and Chris for their prepared remarks. Allison, can we please poll for questions?

Questions and Answers

[Operator]

Sure. And we will now begin the question-and-answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick-up your handset before pressing the keys. To withdraw your question, please press star then to. At this time, we will pause for a moment to assemble our roster. The first question today will come from Chris Schott of JP Morgan. Please go-ahead.

[Chris Schott, Analyst at JP Morgan Cazenove]

Great. Thanks so much. Just two quick ones for me. First on, it seems like feedback and coverage dynamics are progressing well. Can you just elaborate on how you're thinking about the ramp of the drug from here as we balance, as you highlight, kind of entrenched physician prescribing habits against what seems like a relatively poor standard-of-care and pretty large unmet need in this space. I'm just trying to get a sense of like the ramp, how you're thinking about it for '25.

And the second one is just on the cost program. Once you're done with this incremental $2 billion, should we think about additional cost opportunities as you go through that 2028 LOE cycle? Or is this going to really put the company in the, I guess, the right place as we think about the longer-term model and longer-term business? So basically kind of thinking about is the '27 run-rate kind of a good way to think about this or is there another step-down as we head into Eliquis and Opdivo? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks for the questions

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

, Chris. I'll have Adam take the first question and then I'll take the second. Adam.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Great. Thanks, Chris. So regards to, we're very pleased what we're seeing with with three months post-launch and the launch is really off to a strong start. We're now at approximately 1,000 TRxs per week. And we made very good progress achieving our access goals. So for Medicaid and Medicare, we're tracking ahead of our expectations. We've achieved over 90% Medicaid access and over 80% Medicare access. Recall, those two payers represent over 80% of the covered lives in this category. And as expected, the majority have one-step edit post generic. We're also making very good progress with commercial payers. The feedback over the last several months has been very positive. There's been a lot of enthusiasm around the efficacy and safety profile. I'm also pleased with the number of trialists that we're seeing since launch, and we have an opportunity to further expand and increase adoption with roughly 30,000 psychiatrists.

So as you say, this is the first new mechanism-of-action in decades in the treatment of schizophrenia. And so we're out with our teams educating customers on differentiated profile and we're breaking reflexive prescribing habits and that's going to take some time. So we would expect to see continued strong uptake through 2025. And as we said, with a ramp-in the back-half of this year. But taken together, you know, we are really pleased with what we're seeing so-far and we plan to make this a very big product for the company over-time.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

Thanks, Adam. And Chris, with respect to the second part of your question on the cost program, let me say a few things. First, as you think about this cost program, keep in mind that our focus as a company continues to be on investing for growth. That's investing in the products that we have today, investing in the pipeline, both the late-stage pipeline as well as promising early areas of science. And maybe just give you two quick vignettes on that. We plan to initiate seven Phase-3 programs starting this year-on, clearly illustrating that we'll continue to invest in our pipeline. And then Adam can speak to this, but we made significant up investments in commercial last year, which explains, we believe part of the progress that we've made on products like Camzyos, Opdivo and. So investing in growth is a priority for us and that's the top priority. With respect to the cost programs, just a bit of context. As we were executing on last year's program, we cataloged a number of opportunities for us to become a more agile company to become more nimble and speedy in terms of how we operate.

And given where we are on that program as well as where we are with respect to LOEs, we think it makes sense for us to capitalize on those opportunities now. So that's really driven the timing of this announcement, and we think it puts us in a good position going-forward. With respect to this -- the follow-up to that, which is, will there be additional cost-cutting efforts there, I think we're always going to align the organization to the needs of the business. This is an extension of last year's program. It gives us more financial flexibility. That financial flexibility gives us strategic flexibility, but we're always going to be focused on ensuring that we've rightsized the organization and we've got the right level of spend given where the business is.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thanks, Chris. Allison, can we go to our next question?

[Operator]

Next question will come from Louisa Hector of Berenberg. Please go-ahead.

[Luisa Hector, Analyst at Berenberg Bank]

Hello, thank you for taking my questions. I just wanted to check your assumption for Part-D redesign, if you can quantify it on in 2025. And then just an update on. I don't see it on the slides, but any update on the filing plans there? Thank you.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thanks for the question, Louis. I'll have Adam take both of those questions.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Thanks, Louisa. Good morning. As it relates to Part-D redesign, there are pushes and pulls. Overall, we're going to see favorability with Eliquis due to the elimination of the coverage gap. And with that, we're not going to see the historical dynamics with Eliquis where first-half sales have been higher than the second-half sales. In fact, what we're going to see in Q1 is going to be the lowest quarter of sales for Eliquis, in fact, mid-single-digit sequential growth from Q4 to-Q1 globally and we'll see second-half sales be higher than first-half sales. But for the full-year, we expect strong year-on-year growth for Eliquis.

So when you look at products like Revlimid,, and Camzyos, for example, that's going to offset the Eliquis favorability as we see increasing gross-to-net pressures starting in Q1 as patients enter the catastrophic phase. And as you know, we're responsible for 20% in the catastrophic phase and 10% in the initial coverage phase. But as we've said previously, we project this to be roughly net neutral across our portfolio this year. As it relates to sendakimab, given the data that we have seen, we've made the decision not to commercialize sendakimab.

And we're going to continue to prioritize investments in opportunities where we have a competitive advantage. We can deliver the highest-return for the company in areas where we believe that we have an opportunity to deliver potentially transformational outcomes for patients. We made a similar decision late last year with in UC as we saw the unsuccessful trial in Crohn's disease and based on our competitive position with IBD, we made that decision as well.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thanks, Adam. Next question, please, Alison.

[Operator]

The next question will come from Jeff of Citi. Please go-ahead.

[Geoff, Analyst at Smith Barney Citigroup]

Great. Good morning, guys. Thanks so much for the question. I had another one on. I know, Chris, you highlighted the expansion opportunities on Slide 6. I guess, are there others that you could add or accelerate the -- beyond what you have? I guess the main question is since the emraclidine failure, are there changes to the investment plan that you're contemplating? And then on the policy front, want to get your perspective as RFKJ's nomination or a confirmation looks, I think, fairly eminent. What are the potential puts and takes on IRA revisions? Obviously, been a lot of chatter on what discounting could look like in the outer years. Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Sure. I'll take the first part of that question and then turn it over to Samit and Adam, and then I'll come back and talk about the policy bit. Just let me give you a top-line on. Obviously the competitive dynamics and changes on the competitive front have an impacted the short-term on that product. We have always been focused on delivering that product as quickly as possible to patients. However, we do believe that those competitive dynamics provides a more significant long-term opportunity for us. And so we have put a full-court press on ensuring that we do everything we can to capitalize on that opportunity in the long-term and that includes accelerating programs where possible. So maybe Samit and Adam want to comment.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Yeah, absolutely true what Chris just said, because if you think about the dual muscarinic agonism, mechanism-of-action that the drug carries, it opens up the door for investigating and exploring many of the dementia associated psychosis and agitation disorders. So we will continue to explore where the drug could be applied, where additional indications could be added and how we can accelerate the development of this molecule and as well as continue to look into our pipeline, what other molecules we can bring forward in the neuropsychiatric space to be able to manage the unmet medical need that exists for these patients at this time.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

I'll just add, Samit, our focus has been on ensuring a successful launch where generics atypicals have about 80% market-share and has significant safety and efficacy advantages there. And as Samit just mentioned, we see the unique efficacy advantages around the three domains of schizophrenia hitting on positive symptoms, negative symptoms and cognition due to its unique mexis action. So we didn't expect competition from other muscarinics in schizophrenia until late '26 or early '27 and the failure of emraclidine, we have a clear path forward in schizophrenia and we're excited about the opportunity with. And we believe that we're going to drive meaningful growth for really into the middle of the next decade.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

On the policy front, maybe just a few things. First, as a company, as you well know, we have a long history of working across both sides of the aisle. We actually look-forward to working with the new Congress as well as President Trump's administration, including nominees like RFK once those nominees obviously are confirmed. Our focus as a company is going to continue to be on policies that strengthen the ecosystem for innovation that make sure that we're ensuring to address the needs of patients and our employees. Also, I would add ensuring that the FDA has what it needs to fulfill its mission.

And so that's going to be our focus as a company. With respect to IRA specifically, I do think there's an opportunity for us to address in the coming administration some of the challenges as one of the first companies to go through the IRA price setting process. We've been very clear on concerns that we have with that law and we see the need to have a number of fixes that will avoid some of the more damaging aspects of the law and some of the more perverse incentives -- incentives. And I would highlight addressing the bill penalty and addressing the spillover impact as two of the most important areas that we'll be focused on. And of course, there are other policy priorities. But in general, we look-forward to working with this administration and we think we've got some opportunities to do so.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thank you, Chris. Next question, please, Allison.

[Operator]

And The next question will come from Chris Shibutani of Goldman Sachs. Please go-ahead.

[Chris Shibutani, Analyst at The Goldman Sachs Group]

Thank you. Good morning. I'm struck by the ability to do several things at the same time while trying to realign your costs and integrate these businesses. There have been several advancements of timelines in terms of data readouts and there's also been an absence of slippage across integrating aspects of the pipeline that are very important. What are the keys in your opinion to being able to deliver on this progress and in particular, the advancement of timelines.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Maybe I'll start and then turn it over to Samit. I think, Chris, you've correctly pointed out there are a lot of moving parts, but I would say one of the reasons that we've been fixated on operational excellence becoming a more nimble and focused organization is making sure that we're staying absolutely focused on those things that are going to drive value to the company and value to shareholders. And so one of those things has been a very laser-like focus on R&D productivity.

The work that we've done in that regard has enabled us to accelerate a number of programs that are going to add value for the company. In fact, one of the reasons we have this wave of catalysts that are coming forward over the next 24 months is that we have been focused on ensuring we hit the timelines that we set internally and where possible accelerate and Simon's team has done a nice job of helping us do that. So, Simon, do you want to comment on specifics? Y

[Samit Hirawat, Chief Medical Officer and Head of Development at Bristol-Myers Squibb]

Eah, absolutely. Thank you for the question, Chris. As Chris just said, the laser-focus is the start, but then again, following the principles we laid out a few years back, in fact, between Robert and myself from the research and discovery perspective, the cause of biology to discover the drugs, matching the modality to the mechanisms and then picking the right diseases. And then after that, accelerating that proof of proof-of-concept generation.

But then if you look at the late development, we broke down the process into multiple pieces and dig deeper into where we were doing well, whereas where were the spaces where we had the opportunity to shorten the timelines. And there we identified several opportunities and then we started to dig deeper into it. The other thing we did last year is also prioritize our portfolio and made certain decisions what we will pursue versus what we will not pursue.

Some assets, some trials were stopped and then we started focusing on where the most amount of scientific rigor was there to be able to achieve the proof-of-concept. And once that was achieved, how do we then accelerate that into generation of the data to bring the drug through the patients and to commercialization. All of that has helped. And the examples that are right in front of you, last year, we were able to accelerate and deliver the psoriatic arthritis data early. This year, we'll be able to give data early. This year, we'll be able to bring in ADAPT. And now we are working on the next trial as well as we think about multiple myeloma, LPA1 and IPF as well as SLE trials for Sotyktu. And of course, that mindset will go in all of these seven trials that we've talked about for as well. So overall, very pleased with the progress we've made, but we have a little bit more distance to go and we'll continue to focus on our portfolio to deliver that.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

And just to put a finer point on what Samit said, Chris, we have the potential for 15 or more registrational trials that will read-out by the end of next year. And so the work that Samit's team is doing to ensure that those are delivered, delivered on-time is we think critical and we've made good progress in 2024. And as Samit said, we're heads-down continuing to execute on that.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

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

[Operator]

And the next question will come from Tim Anderson of Bank of America. Please go-ahead.

[Tim Anderson, Analyst at Bank of America]

Thank you very much. I have a couple of questions. So the revenue guidance for '25 is about $1 billion less than consensus. In as much as you've looked at consensus, where are you seeing the biggest differences? Could Cobenti be one of those contributors of the delta? And then a longer-term question on earnings. In the past, Chris, you've suggested trough earnings would really be in the very late 2020s. And to me it felt like maybe 2028, 2029, is that still the right way to think about it? And could a product like or some of these other programs possibly pull that forward?

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks for the questions, Tim. Maybe I'll start and then turn it over to David for the first part of your question, then I'll come back for the second part. Look, with respect to how we thought about -- thought about guidance and the outlook for this year. I think you as well as, I think everybody knows the LOE exposure that we have as a company as expected this year, we're seeing the increased step-down on Revlimid as well as the stacking of full-year impacts of products like, which lost exclusivity in Europe as well as in the US price on a braxane and our guidance reflects that. But keep in mind, those are short-term impacts.

And the long-term, which is what we're focused on, we feel-good about the progression that we're making on the new product portfolio. And then as we discussed just in the last question, we have an exciting set of assets that are going to be reading out that will frame out what the company looks like in the back part of the decade. And then maybe I'll ask David to fill-in some of the specifics on the LOEs and the guidance.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

Yes. Tim, thank you for the question. And just as a reminder, Bloomberg's for the total company is sitting around 46.2 million, we're guiding approximately 45.5 million. If you remember in my prepared remarks, said there is a headwind of currency, which we don't believe has been built-in, which is around $500 million. So as we look at where we are versus consensus from a revenue perspective, we're broadly in-line with where it is. Any minor differences is really as we keep you highlighting is around the legacy portfolio, in particular, coming down to 2.5 as well as the other generic impacts that we mentioned on the call. But overall, we feel pretty good where we are versus consensus.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

With respect to the trough question, first, I think the way you're thinking about the trough in general is the right way to think about it. As we've said before, we're not going to be giving long-term guidance as a standard course. This reflects the philosophy that we have that we're going to guide to what we and you can hold us accountable for. But what we've also been very clear on is that our focus continues to be on driving top-tier growth exiting this decade. And specifically, that means increasing the velocity of growth that we have in the last couple of years, exiting this decade and into the next.

So as it relates to trough, we're working to do everything we can to change the timing, the depth and duration of that. And how we do that is to continue to do more of what we frankly did last year, drive brand -- growth brand performance, accelerate the pipeline so that we derisk some of these future catalysts as quickly as possible. Use our capital to accelerate growth. Frankly, that's what we did when we acquired Karuna to bring a product like into the portfolio.

And in fact, as a result of that and what we see as the long-term potential, we believe we've accelerated the velocity of growth as we exit this decade. So we're going to continue to be focused on finding ways to use capital to continue to accelerate the growth profile. And we're going to become more nimble as a company, so we can move quickly to capitalize on those. That's what we're focused on and that's what we're going to be transparent about our performance against on these calls.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thank you, Chris. So Allison, let's move to the next question.

[Operator]

Our next question will come from Mohi Bansal of Wells Fargo. Please go-ahead.

[Mohit Bansal, Analyst at Wells Fargo & Company]

Great. Thank you very much for taking my question. My question is regarding AliQuest. So I mean, look, there was some thoughts about getting some tailwind because of RD InDesign given that there is no doughnut hole now and maybe there is like given the price point, the impact of design may not be a lot. So in the context of that, how are you thinking about the growth for this brand for this year? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks for the question, Mohit. Adam, you want to take that?

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Yeah, Mohit, thanks for the question. As I mentioned, we're going to see favorability with Eliquis this year in the US through the Part-D redesign with the elimination of the coverage gap. And so I talked about the dynamics historically where the first-half sales were higher than the second-half sales. So we're going to see something very different this year where Q1 sales will be the lowest quarter for Eliquis and we'll see higher sales in the second-half of the year.

For the year, we expect strong double-digit growth for Eliquis overall. And we look at where we are position in the market in the US, we have a market-share that continues to grow linearly. Our share in the US NBRx is roughly 75% and we know that with Zorelto out-of-the market, we've got a great opportunity to continue to drive this important brand for the company.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thanks, Adam. Next question, please.

[Operator]

Next question will come from Trang Hun of UBS. Please go-ahead.

[Trung Huynh, Analyst at UBS Group]

Hi guys. Thanks for taking my question. Just two, please. So firstly, can you just give us some color on the gross margin cadence for 2025, you touched upon 1Q dynamics, but should we just follow the Revlimid step-downs for the year? Is there any other considerations that we should think about here? And then just wondering if you can give us any early insights into the access and coverage of Opdivo and any thoughts on the uptake for '25? Thanks.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks for the questions from David, you want to take the first one and then Adam you can comment on the second.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

As you said, the step-down will be mainly driven by Revlimed and volumes coming through with those gross margins being slightly

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Higher than the average. And the only other consideration, obviously is Eliquis. And I think as Adam had covered, typically Eliquis is larger in the first-half of the year than the second-half of the year. This year that's going to be inverted in that our lowest quarter for Eliquis will be the first-quarter, but our sales will be higher in the second-half of the year than the first-half of the year. So that would be the other consideration as you think through the gross margin of the company in total.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

Yeah. So as it relates to Optivo, these are very early days. The team is out in the field educating healthcare practitioners on the benefits of subcu versus IV. As we said previously, we believe physicians will convert at least 30% to 40% of the IV business ahead of our LOE in late 2028, which will extend the franchise into the 2030s. We have seen so-far some very positive feedback early-on is around usage in adjuvant patients, patients who are treated in combination with Yervoy like in first-line metastatic melanoma, first-line RCC. The feedback specifically has been positive regarding the three to five-minute infusion time really taking off that treatment burden for both physicians and for patients.

We've also seen a number of NCCN guidelines updated for your reimbursement question to include within just a few weeks after approval. I think the most common question that we're getting is around the reimbursement dynamics here. And we've said conversion from IV subcu in the first-half of the year is going to take some time, mainly due to a temporary J-code, which is routine for any new product in this category. And conversion will accelerate in the second-half of the year once we transition to a permanent J-code on July 1. And so we're excited about the launch and what this means for patients, physicians and importantly, the durability of our IO franchise.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thank you, Adam. Let's go to our next question, please.

[Operator]

Next question will come from Evan of BMO Capital Markets. Please go-ahead.

[Evan Seigerman, Analyst at BMO Capital Markets]

Hi, guys. Thank you so much for taking my question. One on BD, more specifically, now that we're on this side of the debate with approved and in efficacy, can you walk us through kind of your process in determining why you went for when you wanted to get into schizophrenia and on kind of a more mechanistic perspective, what's happening with? We saw a nice step-up. What are you seeing in the field that's driving the uptake there? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks for the questions, Evan. I'll start and then turn it over to Adam. There's no magic bullet with respect to how you approach business development from our standpoint, but I think there were a few things that we did well with the Karuna acquisition that will frame how we continue to do business development. First, I would note that the senior leadership team of the company-owned the decision to move forward with that acquisition.

Capital allocation is critically important as we've discussed. Business development is a top priority for us as a company. It's important as we navigate the back part of this decade. And when you're allocating investor capital at that scale, it's critical that senior leaders take ownership and accountability for it. So we did that. Second, we were very disciplined in the approach. It started with making sure that we really like the science. We considered multiple options and we zeroed in on the science that was coming out of Karuna as compelling in our view. And beyond that, we felt strongly that this had an opportunity to strengthen our therapeutic areas as well as to give us opportunities to accelerate growth in the back part of the decade.

And of course, we were very disciplined on the financials. We needed to make sure that we could put a compelling case together that it would add value to the company and ultimately to shareholders. You actually saw how we executed against that post the decision to acquire in that we spent a lot of time with the Heritage Karuna team to fully develop this asset in ways that they were unable to do so. And we think that's important in terms of how we think about the long-term opportunity. And maybe the last lesson learned that I'd highlight is we moved very quickly. And so those lessons, I think will frame out how we continue to do business development at the company. And then Adam, do you want to take the second question?

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Yeah, Evan, regarding Camzyos, we've seen strong steady and consistent growth from Camzyos, as you heard from David's opening remarks, year-end 2024, there were approximately 12,000 patients in the hub and roughly 9,500 patients on commercial drug. So we've established a strong revenue base and we expect continued growth from the expansion of our prescriber base. We're seeing high persistency and duration of therapy.

And we're continuing to add new patients each and every week. So our focus is now on increasing depth of prescribing in the larger COEs, while at the same time increasing breadth in some of the smaller institutions and larger community practices and we're making some good progress there. We also have a couple of things David mentioned, one, we look-forward to the PDUFA date that's coming in April. So similar to what we've seen in Europe, our goal is to ease the burden of echo requirements for patients and physicians and we expect that to open up additional capacity at the COEs. And as a result, physicians will be able to treat more patients. And as you're also aware, we have a data readout in non-obstructive HCM and we're looking-forward to seeing the Odyssey data in Q2 and that will expand the eligible patient population by about 30% or so.

And so that's going to allow Camzyos to have a nice first-mover advantage in both indications and across the full-spectrum of patients with symptomatic HCM.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thank you, Adam. Let's take our next question, please.

[Operator]

Next question will come from Akash Tewari of Jefferies. Please go-ahead.

[Akash Tewari, Analyst at Jefferies Financial Group]

Hey, hey, thanks so much. So what's the risk around the adjunct schizophrenia trial for because we haven't seen a lot of companies run that specific trial and if they have, they've often failed. So why wouldn't the probability of success for this trial be more like a 50-50 coin flip. And on the label update, are you aiming for six-month echo monitoring requirements? And if so, how do you think that will help expand access into the community setting? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks for the question, Samit and Adam.

[Samit Hirawat, Chief Medical Officer and Head of Development at Bristol-Myers Squibb]

Yeah, sure. Thank you for the question. On the adjective schizophrenia, remember where we started-off and how patients are treated in the in the real-world. So we obviously have developed the drug as a monotherapy, but these patients were primarily -- before they got onto the trial were receiving the D2 agonist. And thereafter, there was a washout period, patients came on the drug and then of course, the trial evaluated the primary endpoint in EMERGENT 1, 2 and 3 at a shorter window. But remember, at EMERGENT 4 and 5 have now read-out with a 52-week follow-up. Many of those patients obviously are also taking concomitant medications in the background. So -- and we've seen that efficacy continue to be maintained within -- as we look towards the 52-week data point as well. So overall, from that perspective, we are confident on the overall safety profile that is emerging on that. And then, of course, from a blinded data perspective, the study has continued at this point. So now we are only a few months away from the readout for that trial.

And of course, on-top of that, we will look at ADAPT trials also reading out beginning at the back-end of this year. Coming to, just a point that I would like to make is it is very important that we continue to decrease the burden on the sites, on the patients and the treating physicians. And from that perspective, it was important, the data that we've collected from the real-world as well as from the clinical trials suggests that the overall safety profile of is maintained.

Many of the patients are treated actually at the lowest doses of 2.5 and 5 milligrams. And considering all of that data is where we approach the health authorities and you've already seen the action taken in Europe and now looking-forward to the April action as we think about the maintenance for these patients with longer duration in-between echoes as we look to the US reviews as well. Adam, if you want to add anything?

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Just adding just one bit, you can point you to the European label. The label was updated late last year to reduce the frequency of echo monitoring for patients taking Camzyos from every 12 weeks to once every six months when patients are in the maintenance phase. So that's after week-12. And what we would expect is not so much in the community, but this will open up additional capacity at the centers of excellence. And as a result, physicians will be able to treat more patients.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

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

[Operator]

Next question will come from Terence Flynn of Morgan Stanley. Please go-ahead.

[Terence Flynn, Analyst at Morgan Stanley]

Great. Thanks for taking the questions. Maybe two for me. David, I just wanted to clarify on the new productivity initiative, should we think about the run-rate for year-end '27 as being $15 billion? So an incremental $1 billion off of the $16 billion now. I just wanted to make sure I understood it correctly. And then on ibertamide, the addition of the MRD endpoint, did FDA sign-off on that? And if so, are you able to get approval on just an MRD endpoint or do you need follow-up data from the PFS? And anything you can say about what kind of efficacy delta you'd need on MRD? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks, Karen David Amit.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

Yeah, this is thanks for the question. Yes, you have that right. So we said an incremental to $2 billion program, all that dropping to the bottom-line. We said $1 billion of that would drop this year with operating expenses of $16 billion. The further $1 billion achieved by 2027 would get you to operating expenses of $15 billion. In terms of thinking about iberidamide, of course, quite excited that based on the discussions that you probably followed from the ODAC setting perspective MRD as an endpoint is more-and-more becoming important because in multiple myeloma, there are multiple lines of therapies that are available, but still no cure available for patients with multiple myeloma. So it is important that we continue to figure out how to accelerate the process of drug development and that's why newer endpoints are needed. So of course, we've discussed with the FDA the ability to include MRD as one of the primary endpoints in the clinical trial, and we'll certainly be reading that out most likely in this year. Now everything in the regulatory world will be dependent on the risk-benefit ratio and the overall magnitude that we will observe at the end-of-the day.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

So when the data is available, that's when we will engage with the regulators in terms of how they will see that data and what else they would need. Remember, we have not taken our PFS as the second primary endpoint within the trial as well. So of course, the patients will be followed for PFS and as well as the secondary endpoints, which is overall survival as well. So we are going to collect maximal data from the clinical trial and engage the authorities based on the magnitude and the timing of the readout.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks, Amit. The only thing, Terrence, I would add and David got it right with respect to how the cost-savings will flow is to -- as I said earlier on this call, keep in mind that as we think about the overall cost structure, as we see compelling opportunities for growth that exist, we're going to make sure that we continue to invest in those. So just keep that in mind is framing all of this discussion around cost. Right.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thank you. Let's move to our next question, please.

[Operator]

Our next question will come from Courtney Brain of Bernstein. Please go-ahead.

[Courtney Breen, Analyst at Bernstein SG]

Thanks so much for taking my call today. My question today on the call. Two-parts. I think you spoke a little bit about business development and-answer before and referenced it as the top priority from a capital allocation perspective. Can you just talk a little bit about kind of TA alignment, kind of what good looks like, particularly in the context of the organization you have right now. I think last year was a little bit of digesting the deals that you've done quickly. And so wanting to understand kind of how you're thinking about that appetite now and over the course of the year.

And then the second was just around kind of fee and specifically kind of gross-to-net evolution as we're thinking about this access evolving from kind of initial private-pay to more of the of the government setting to then adding on a little bit of the commercial environment. That would be really helpful to understand how you're expecting that to flow. Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Both good questions. I'll start and then turn it over to Adam. As we said earlier, and as you reiterated, business development is a top priority for us. Think about that both in terms of partnerships and where it makes sense acquisitions. And the way we think about therapeutic areas is that we're really focused on strengthening our position in the core therapeutic areas that we have today. And that we can do by bringing promising areas of science into the company as well as looking for assets that can improve the growth profile of the company.

And I think you saw shortly after I became CEO in 2023, we did both of those things. What's important and the way we think about it is that we need to like the science and feel that we're the rightful owners of it. The financials have to make sense. And again, we've included in that thinking, strengthening the growth profile as a key factor we're considering. And we have to believe that we can drive value for the company and ultimately for shareholders.

And as we look across the core therapeutic areas that we have today, we see opportunities as we see opportunities to strengthen our position in those therapeutic areas. The nice thing is that we're in a very strong financial position. And as I said earlier, that financial strength and flexibility gives us strategic flexibility and that flexibility includes doing business development where it makes sense.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Great. Thank you, Chris. Always answer the question around gross-to-net, Courtney. Thanks for the question. It relates to gross-to-net be, the brand is going to continue to lean heavily towards the public sector, Medicare and Medicaid. And you think about the evolution of schizophrenia and schizophrenia indications or our Alzheimer's indications, whether it be Alzheimer's psychosis or Alzheimer's cognition, these are patients who are going to be in Medicare or Medicaid. Commercial patients are less than 10%, you will see that more commonly in some of the indications such as autism and in bipolar disorder, but the majority of the brand will largely be in the public sector where there are Medicaid best price.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

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

[Operator]

Next question will come from Seamus Fernandez of Guggenheim Securities. Please go-ahead.

[Seamus Fernandez, Analyst at Guggenheim]

Oh, great. Thanks for the question. So just quickly on, I was hoping you could talk about the patient experience that you're seeing so-far in the field. We know that patients certainly feel better cognitively, but there are questions around the tolerability and the VID dosing. So just interested to know if there's any early signs of sort of the durability and how you're managing the GI profile that's been talked about a bit by some thought leaders in that regard. And then the second question is just as we think about the overall kind of multiple myeloma opportunity, just hoping to get a sense of where you think novel oral drugs like ibertamide or could appropriately fit within the context of the overall multiple myeloma market given the availability of generic Revlimed and? Thanks.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks, Seamus, Adam. And then maybe Sama can chime in as well.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Yeah, Seamus, thanks for the questions. We've been really pleased with what we're hearing from both physicians and patients. The feedback has been very positive with a lot of enthusiasm on the efficacy and the safety profile. So what we're hearing is patients are seeing improvement in positive symptoms as early as the first week of treatment and on really the lowest dose, 50 milligrams. And we're also hearing good successes on negative symptoms and what we were really excited about this asset for improvement in clarity of thought, improvement of cognition, patients being able to reengage with their families and even start thinking about going back to work.

The AEs, what we've heard from physicians, they're manageable including the nausea and vomiting because what we're seeing is the majority of physicians in the real-world are treating patients at the lowest dose. They're starting with 50 milligrams, they're taking a week or two before they titrate up to the next doses at 100, unlike what you saw in the clinical trials, which moved to 125 milligrams within the first eight days of the trial. So that has been incredibly positively received. And so we're not hearing a lot of the GI tolerability issues from physicians, but our teams are out there making sure that we're educating on what to expect.

As it relates to BID, we know that on average patients are on seven pills per day. And so we're not hearing this as a major objection to prescribing. And we -- last thing I'll mention is we've got an ongoing study looking at taking with food that will read-out this year, so that will also improve the ease of prescribing for physicians and make it easier for patients as well.

[Samit Hirawat, Chief Medical Officer and Head of Development at Bristol-Myers Squibb]

So I'll just take it off from there. And one thing that I would just add-on. So prior to, what drugs were doing was treating the symptoms of schizophrenia, meaning the positive symptoms primarily. With, now we are treating schizophrenia, meaning also impacting the negative symptoms and we are seeing the impact on cognition as we have recently published the data on multiple myeloma switching gears, it's important to understand where the patients are treated and what the drugs are available. If you think about the cell therapies and the T-cell engagers or bispecifics, they are to be primarily used in the academic setting -- settings, whereas most of the patients with multiple myeloma, especially with the relapsed-refractory disease are being treated in the community setting where it is very difficult to get these therapies with the side-effect management and the REMS program that go along with them.

And that's where it is very important to continue to develop small molecules, which are easy to deliver and can be combined with the standard-of-care therapies and that's exactly where and fit. And you know mezigdomide is being compared head-to-head versus thomalidomide and that's how you replace thomalidomide. And then of course, there's another trial looking head-to-head iberdomide versus, which certainly will read-out later, but it is a very important component of the overall development plan.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thanks,. Next question, please, Allison.

[Operator]

Our next question will come from David Rosinger of Partners. Please go-ahead.

[David Risinger, Analyst at Leerink Partners]

Yes, thanks very much and congrats on all the updates. Sorry, I have another call coming in here. So my apologies. They want me on -- they want me on the box to speak. So I have two questions. First, with respect to the performance in '25, so obviously, the worst worse that the LOEs perform in '25 The better the setup for the trajectory of growth for the company in '26. But if the loss of exclusivity products perform better-than-expected, then it makes it a little bit tougher to grow in '26. Could you just discuss that a little bit and provide some initial context for '26? I know that you're not providing guidance at this time. And then second, just with respect to Yervoy, it's been performing very strongly, growing 20% roughly in the 4th-quarter and roughly 20% for full-year 2025 -- sorry, 2024, can you comment on growth prospects for going-forward as well? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks, David. David, Elkins and then Adam.

[David Elkins, Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb]

Yeah. So just on your question around '25 and it's what to think about heading into '26. First, you know, look, Revlimid, as we said, we have additional generic entry coming. So about 70% of the market will be supplied by generics. Remember, for Revlimid, full generic entry in January of '26. So we'll be through that by the end-of-the year. And we have generic entry next year as well. And the only other headwind that I would mention is we provided that guidance on IRA, which really took out the worst-case scenario for Eliquis as we head into the IRA in '26 and '27.

But really, our focus remains on investing in the growth drivers. You saw the strong execution in that growth portfolio. That's now greater than 50% of our business. We exited double-digit growth last year. We feel really good about the position that we're in this year. And then as you think about going into '26 with that growth portfolio, you heard Adam talk about the additional indications in Canzyos and Sotyktu well as and we got some really important data readouts that we're going to be able to add-up to six new MMEs here over the next two years.

So that growth portfolio is really coming together. We're adding to that. And then you've heard all the commentary around Cobenzi further adding to that growth portfolio. So there's pushes and pulls there, but what's becoming clear is the strength of the growth profile as we go into the second-half of the decade here.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

As it relates to, we're seeing solid demand growth across our core indications, first-line long, first-line RTC as well as first-line melanoma where voice is using combination and that growth is coming both from the US and from our international markets. In the US, we continue to see good adoption in the community. And as you know, last year, we presented, I think is remarkable 10-year long-term data in first-line melanoma. I think the last thing I'd say is we're also preparing for launches this year in first-line HCC and first-line MSI-high CRC, both in combination with Irvoy, which will help drive errvoy performance. And we also have Opdivo Yervoy lung approval that's pending in China. So taken together, we would expect continued growth from Yervoy in '25.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

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

[Operator]

Next question will come from Matt Phipps of William Blair. Please go-ahead.

[Matt Phipps, Analyst at William Blair]

Hi, thanks for taking my questions. Following-up on the MRD primary endpoint for the trial, is there a time course of the FDA once as far as how much durability on that MRD? And why not add MRD endpoints to the trials? It does look like you already have MRD on the quintessential. And then similarly in multiple myeloma, is there a point at which Abecma -- what is kind of the profitability breakpoint for Abecma and does success of ARLO-cel really kind of negate the need for Abecma? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks, Matt, and Samit and Adam.

[Samit Hirawat, Chief Medical Officer and Head of Development at Bristol-Myers Squibb]

Sure. Thank you, Matt, for the question. So for multiple myeloma, look, MRD endpoint is something that is new from the perspective of using as a registration trial endpoint. And that's why we have to continue to follow the patients and provide the durability in terms of not only MRD, but also overall response rate, CR rate that we will see. And these will be the points of discussion with the FDA as we get into those time points once the magnitude is known for this endpoint as well as the events occur in the iberdomide trial.

In terms of how we are thinking about use of this particular endpoint for other trials, we are continuing to evaluate the potential to leverage an earlier MRD endpoint readout to accelerate the development of our multiple myeloma assets across-the-board, but it will all depend on the timing, the population as well as how the event accrual is occurring. Successor studies target a little bit more of a difficult-to-treat patient population. So we'll see how the event occurrence happens and that may become as one of the studies that we may consider an endpoint as well in the future, but not at this time.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

As it relates to, we know multiple myeloma is going to remain a very crowded and competitive space and there are multiple treatment options available. We remain committed to Abecma, but we're going to see continued competitive intensity and competitive pressures. So our focus is making sure that we're optimizing the value of Abecma and we're going to remain competitive in this space. As you heard earlier from Chris and David, we're very excited also about GPRC5D, which we believe is going to play a critically important role in the treatment of post BCMA CAR-T with a single infusion and an improved safety profile.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thanks, Adam., let's take our next question, please.

[Operator]

So our next question will come from Steven Scaler of TD Cowen. Please go-ahead.

[Steve Scala, Analyst at TD Cowen]

Well, thank you so much. I have two questions. First, Bristol's second-generation TYK2 completed Phase-2 in psoriasis in August of 2024, but hasn't progressed. So curious what the profile of this agent is, what are plans and is IBD within those plans? And secondly, Phase-3 readouts in stroke and ACS are expected in 2026, but later in the year. Curious if events are tracking for that 2026 readout? And is there any possibility at all for a 2025 readout for either trial? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Thanks, Steve, Summit.

[Samit Hirawat, Chief Medical Officer and Head of Development at Bristol-Myers Squibb]

Thanks, Steve, for both the questions. So first of all, for the backup TYK2, we completed those studies. We have the data. But as you know, we are continuing to progress our overall plans for Sotyktu at this time. And as we spoke earlier, we have to decide within our pipeline where we are going to really focus and prioritize. And at the current time, our focus is truly squarely on Sotyktu and maximizing that opportunity from a development and commercial perspective.

So at this time, that TYK2 is not in the development as you already have stated. From the SSP and ACS readout, events are tracking as well as the enrollment is going really well. We do not expect that readout in 2025. We expect that readout as we have stated at the back-end of 2026.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thank you, Charlotte. Next question, please.

[Operator]

Next question will come from of Truist Securities. Please go-ahead.

[Srikripa Devarakonda, Analyst at Truist Financial]

Hey guys, thank you so much for taking my question. I have a question. Congrats on getting the label update in EU. I was wondering with the label change in EU and potentially a change in the US as well. How do you see the peak opportunity now? And with ODYSE data upcoming this year, can you help set expectations for the readout? And then if I can squeak one in -- squeeze one in for. One of the tables we recently spoke to said that there was an issue with drug availability at average pharmacies is what he said. I was wondering if this is just a one-off or just does it just take time to ramp-up availability? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Yeah, so I can certainly take those,. Thank you. So as it relates to the label for Camzyos, as I said, we expect to have a PDUFA date in April of this year. And our goal is to continue to ease the burden of the echo requirements for both patients and physicians and this could open up additional capacity at the COEs. What we are seeing for Camzyos, which is consistent and steady growth. We have a very large revenue base that's building and we continue to expect growth from the expansion of prescribers and high persistency. Patients are staying on treatment for very long-time because they're feeling better.

And so that's going to help with the duration of therapy and we're focused on continuing to add new patients each and every week. As it relates to the Odyssey readout, maybe Samit, if you want to talk a little bit about it, but just as I mentioned, we're looking-forward to seeing top-line data in Q2. This is going to add if positive around a third of patients in HCM and have an opportunity to build upon the success of Camzydos with a strong first-mover advantage across both indications and we're certainly looking-forward to that data readout. And so I'll turn it to Samit to talk a little bit more about NHCM and then I'll quickly answer your Covent fee question performance.

[Samit Hirawat, Chief Medical Officer and Head of Development at Bristol-Myers Squibb]

Yeah, I'll address the question very quickly. The paper from a methodology perspective as well as the baseline characteristics of the patients just published in JACC heart failure. So you can certainly pick it up from there and the primary endpoints of KCCQ and PV02 are well described as well as what the statistical methodology is. So of course, we are looking-forward to the readout and it's just -- I think in the next quarter, we'll be able to see the results and then we'll share that with you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Yeah, just really quickly on that. We are not hearing that. Our teams are out both with physicians, but they're also at the pharmacies

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

As well. So I do think that is potentially a one-off and we want to make sure that the is available broadly across the US so patients can get access to this really important product.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thanks, Adam. Let's go to our next question, please.

[Operator]

Next question will come from Olivia Breyer of Cantor Fitzgerald. Please go-ahead.

[Olivia Brayer, Analyst at Cantor Fitzgerald]

Hey, good morning. Thank you for the question. What data did you submit to the FDA for the less restrictive Camzyos? Did that include anything additional versus what was submitted to EMA? And are you asking the agency for the same two updates that were proposed in the in the December agenda? I think those are around monitoring frequency and the use of LVOT gradient. And then, Adam, I just wanted to clarify one point you made earlier. You said the European label was updated to reduce frequency. I think you said from every 12 weeks to once every six months. Just wanted to clarify that I heard that correctly.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thanks, Samit and Adam.

[Samit Hirawat, Chief Medical Officer and Head of Development at Bristol-Myers Squibb]

Maybe I can start-off. Thanks for the question, Olivia. We will not be able to give you the specifics at this time in terms of the day -- the asks of the FDA. Certainly, there are several of them and then we'll see which ones we are able to have a conversation and get from a relief for the patient perspective. And in terms of the data that were submitted, they come from both clinical trials as well as from the real-world evidence. So overall data package was very strong and we continue to have the dialog with the regulatory agencies.

[Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer at Bristol-Myers Squibb]

Yeah. And Olivia, just to clarify, again, the label in Europe was updated to reduce the frequency of echo monitoring for patients taking post week-12. So after week-12, as patients move into the maintenance phase instead of once a quarter, they're able to now have echoes once every six months.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Thank you, Adam. Next question, please.

[Operator]

Next question will come from James of Deutsche Bank. Please go-ahead.

[James, Analyst at Deutsche Bank Aktiengesellschaft]

Thank you for the question, guys. I just wanted to follow-up on the RISE question. What are BMY's expectations for the PANScore benefit? And then any color on how will be disclosed? Will the NPIC be toplined in the PR and will this be followed by a full dataset at Medical Congress? Thank you.

[Samit Hirawat, Chief Medical Officer and Head of Development at Bristol-Myers Squibb]

Amit. Thank you for the questions. Let me start with the second one for ADAPT. As has been recently done and previously done, at the top-line, when it reads out, we will be putting out a press release. But generally, we do not disclose the data. Those will be presented at our medical conference appropriately and for ARISE again, the magnitude that we are going to be looking for is going to be the difference between the two arms rather than as well as we look the difference that we observed from baseline to the time of readout. So both of those endpoints are going to be important apart from the, of course, the secondary endpoints.

Right now, we are not commenting on the overall magnitude. But here even small differences in terms of the points would be very, very important and clinically meaningful, as you know, in the neuropsychiatric space.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Right. Thank you,. Next question please.

[Operator]

Our next question will come from Sean of Raymond James. Please go-ahead.

[Sean McCutcheon, Analyst at Raymond James]

Hi, guys. Thanks for the question. Can you speak to the expectations for the cadence of data for the targeted radiotherapeutic portfolio and prioritization of further investment in BD and internal development following that investment in the infrastructure in that segment? Thanks.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Yeah. From the bio portfolio perspective, of course, the Phase-3 is already ongoing in. And this is in the patient population that is already received prior to. So it's -- and certainly the Phase-1 data was very strong and we'll continue to look for not only the response rate, but of course, progression-free survival is going to be important to continue to observe in this one as we look to the readout in 2026. As you know that we are also exploring the activity of this drug in-patients with small-cell lung cancer in a Phase-1 study and we recently started the breast cancer program as well.

And from the portfolio perspective, we have -- we're looking-forward to initiation of our Phase-1 program for GPC3 as a new target. And then of course, there's a pipeline behind it in the research space as well.

And the only thing I would add is that we continue to be looking for opportunities to enhance the acquisition of Rays. We believe in this platform and if it's appropriate and it makes sense for us both financially and scientifically, we would consider business development as well.

[Chuck Triano, Senior Vice-President and Head of Investor Relations at Bristol-Myers Squibb]

Great. Thanks, Chris. Operator, we'll take our last question and then we'll turn it to Chris for some closing remarks.

[Operator]

Next question will come from Alexandra Hammond of Wolfe Research. Please go-ahead.

[Alexandra Hammond, Analyst at Wolfe Research]

Thanks for squeezing me in. Just one on Bristol's long-term growth potential. So the team has mentioned an underappreciation of the pipeline. Can you apply the key assets you expect to drive revenue looking to the back-end of the decade, maybe your favorite child or two? Thank you.

[Chris Boerner, Chief Executive Officer at Bristol-Myers Squibb]

Yeah. Well, listen, I'll take that one. We feel great about the pipeline. We have a number of really exciting assets that are coming. We've spoken at length, obviously about. Clearly, we also are very excited about our Cell mod programs. We have multiple Cell mods that we've spoken about today, IBER and, but we haven't spoken about glucotamide. That's a potentially very meaningful product in lymphoma. Is important. So it's very difficult to pick a favorite child here whenever there's such a wealth of opportunity in the late-stage pipeline and we haven't even talked about the next wave of assets, which include some really exciting opportunities, including products like CD19, NexT, ARLDD, in prostate cancer as well as others.

And by the way, I forgot to mention in the first wave of assets, LPA1, which is also a very exciting opportunity. So a plethora of potential catalysts that will be playing out over the next 24 months and we look-forward to seeing them play-out and going from there. So I think with that, we'll close today's call. I appreciate everyone staying on. I know we went a bit long, but hopefully, we're able to get to virtually all of the questions. Let's take a step-back and maybe summarize where we are.

Our priorities as a company, hopefully, you've seen on this call are clear. We're focused on continuing to deliver very strong commercial execution and to deliver on the upcoming pipeline catalyst, some of which we just discussed. We're going to continue to have the ability to enhance value-creation through business development and all the while maintaining strong financial flexibility. As I look at 2024, we made very good progress and I want to recognize our colleagues for all the hard work that they had last year.

We continue to take decisive action to further rightsize our cost structure and invest in future growth. We believe -- we believe these are important next steps in continuing to execute on the multi-year journey that we're on. And of course, we remain committed to our overarching goal, which is to reshape BMS to deliver top-tier growth by the end-of-the decade and most importantly, generate attractive returns for shareholders. So thanks again for tuning in today. And as always, the team is available for follow-ups and have a good rest of the week.

[Operator]

Conference has now concluded. Thank you for attending today's presentation and you may now disconnect

Participants

Corporate Executives

• Chuck Triano, Senior Vice-President and Head of Investor Relations
• Chris Boerner, Chief Executive Officer
• David Elkins, Executive Vice President and Chief Financial Officer
• Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer
• Samit Hirawat, Chief Medical Officer and Head of Development

Analysts

• Chris Schott, JP Morgan Cazenove
• Luisa Hector, Berenberg Bank
• Geoff, Smith Barney Citigroup
• Chris Shibutani, The Goldman Sachs Group, Inc.
• Tim Anderson, Bank of America Co.
• Mohit Bansal, Wells Fargo & Company
• Trung Huynh, UBS Group AG
• Evan Seigerman, BMO Capital Markets
• Akash Tewari, Jefferies Financial Group Inc.
• Terence Flynn, Morgan Stanley
• Courtney Breen, Bernstein SG
• Seamus Fernandez, Guggenheim
• David Risinger, Leerink Partners
• Matt Phipps, William Blair
• Steve Scala, TD Cowen
• Srikripa Devarakonda, Truist Financial Co.
• Olivia Brayer, Cantor Fitzgerald
• James, Deutsche Bank Aktiengesellschaft
• Sean McCutcheon, Raymond James
• Alexandra Hammond, Wolfe Research