Q4 2024 Bristol Myers Squibb Co Earnings Call
Welcome to the Bristol Myers Squibb fourth quarter 2024 earnings conference call.
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Speaker Change: Now I'd like to turn the conference over to Chuck Triano, Senior Vice President and head of Investor Relations. Please go ahead.
Speaker Change: Thank you and good morning, everyone. We appreciate you joining our fourth quarter 2024 earnings call. Joining me. This morning with prepared remarks are Chris Burner, Our board Chair and Chief Executive Officer, and David Elkins, Our Chief Financial Officer also participating in today's call are Adam Lin Koski, our chief commercialization Officer and summit here, what our chief medical.
Speaker Change: Officer and head of global drug development earlier. This morning, we posted our quarterly slide presentation to be M. S. Dot com that you can use to follow along with Christian 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.
Speaker Change: Really from those indicated by those forward looking statements as a result of various important factors, including those discussed in the company's S. E. 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.
Speaker Change: 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 P. M. S. Dotcom finally, unless otherwise stated all comparisons are made from.
Speaker Change: In 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. Thank you Chuck and thank you all for joining US. This morning, as well discuss today Twenty-twenty bore was a year of good execution across multiple.
Chris Burner: Couple fronts importantly, our performance last year establishes a solid foundation to continue our multiyear journey to achieve top tier sustainable growth by the end of the decade I will begin with some comments on our fourth quarter and full year accomplishments, then I will speak to the promise, we see with cobin P and the steady cadence of clinical data catalysts that will begin this.
Chris Burner: Year further defining our future growth potential I will end with an overview of our 2025 guidance starting on slide four we closed 2024 with strong fourth 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 five I'm pleased with the progress we've made executing on our multiyear plan for the year the growth portfolio delivered double digit revenue growth led by Briand Z Kim Dias rebel assault and Abdulla <unk> in the latter part of the year, we reestablished our presence.
Chris Burner: In neuroscience with the U S approval and launch of <unk>, which is the first novel mechanism for the treatment of schizophrenia. In decades. We also received U S approval of Opdivo Cube Antiguan late December this new subcutaneous formulation of Napoleon Mab will help extend the reach and impact of our immuno oncology franchise to patients into the <unk>.
Chris Burner: Decade throughout 'twenty, 'twenty, four operational excellence and financial discipline, where 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 of this year. Additionally, we put considered.
Chris Burner: We'll focus in 'twenty 'twenty four on improving R&D productivity as a result, we've been able to accelerate several programs and our late stage pipeline. Notable examples include Kim's iOS, where we completed enrollment in the Odyssey non obstructive HCM study six months earlier than expected and now anticipate topline results next quarter with Cobin P.
Chris Burner: The adept to study and all timers 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 Corona and with our Alberta might Excalibur 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 edition of M. R. D. 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.
Chris Burner: 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 detail. 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.
Chris Burner: This is a journey, but we're already seeing progress I'm confident the actions. We're taking are the right ones that will further advance our long term sustainable growth strategy turning to slide six the U S approval of Cobin P. In schizophrenia was an important achievement in 'twenty 'twenty four and the launch is off to a great start while we're focused on delivering on the schizophrenia indication.
Chris Burner: Today, we see the potential for additional benefit to patients and have made strategic investments in our broad clinical development program. We expect to have important data readouts, starting this year and every year thereafter for the remainder of the decade. This year, we're initiating seven phase III studies across three indications Alzheimers disease agitation Halsey.
Chris Burner: <unk> disease cognition, and bipolar one disorder and next year, we plan to begin phase III studies in autism spectrum disorder irritability, the significant ramp up in spending on Coke Denby illustrates our focus on continuing to invest behind key growth drivers, while simultaneously maintaining financial discipline moving to slide seven we are entering a D.
Chris Burner: 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 cobin P. Arise study an adjunctive schizophrenia, then in 2020 six.
Chris Burner: We expect to have Registrational data for numerous potential first and best in class medicines, including mill, Nexsan and acute coronary syndrome, and secondary stroke prevention Admiral power and in idiopathic pulmonary fibrosis and music demise in multiple myeloma. We also expect to have Registrational data for Arlo sell our G. P. R. C. Five D car T.
Chris Burner: In multiple myeloma and for raise 101 and GAAP 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 'twenty 'twenty by guidance and how we see this year playing out on slide eight in terms of the top line, we estimate revenue to be approximately 45 points.
$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 Dave.
Speaker Change: <unk> will provide more details on our guidance finally, turning to slide nine P. M. S 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 cobin V, which has the potential to be a significant contributor to growth over the coming years.
Speaker Change: 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.
Speaker Change: The steps, we are taking to reshape P. M S 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. Thank you, Chris and good morning, everyone. I'll begin my review of our 'twenty 'twenty four financial results focusing on our fourth quarter performance I'll follow up with the introduction.
Speaker Change: 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 'twenty 'twenty. Four 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.
Speaker Change: Slide 11 sales in the fourth 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 Chi brands like rebels L. Prion Z Kim Zions.
Speaker Change: Optimize all achieved significant growth within the legacy portfolio higher sales of Alex's were offset by the expected impact of increased generic volumes across several other brands, including Revlimid, a proxy spray so and palm list overall performance in the fourth quarter capped off a very good year for our company, making progress in building a foundation for long.
Speaker Change: Long term sustainable growth turning to product performance on slide 12, starting with oncology Opdivo delivered solid growth in the fourth quarter, primarily due to higher volume in 2025, we are focused on conversion and educating the U S market on the benefits of Opdivo <unk> and we expect low single digit growth for this product and opdivo taken together with.
Speaker Change: <unk>, we delivered another quarter of double digit growth driven by demand in the U S where it remains a standard of care in first line melanoma ex U S sales benefited from uptake in newly launched markets moving to cardiovascular on slide 13, I'll, let Chris delivered over $3 billion in fourth quarter sales U S sales grew 19% benefiting primarily from continued.
Speaker Change: Strong demand and the typical inventory build importantly, as you think about the impact to our quest for Medicare part D. Redesign Q1 U S sales growth will be tempered sequentially due to the implementation of the 10% manufacture responsibility and initial coverage phase the remaining quarters of 2025 should steadily increase particularly in the second half.
Speaker Change: For the year due to the elimination of the coverage gap turning to <unk> sales in the fourth quarter more than doubled benefiting from higher demand and a large inventory build as the standard of care in obstructive HCM Kim diodes continued to show strong momentum as evidenced by the approximate 1300, new patients on commercial drug in the fourth quarter. Additionally.
Speaker Change: We recently received a label update for Kim Zeiss in Europe to ease their echo monitoring requirements in the maintenance setting for obstructive HCM importantly, we're pleased to announce today that we have a producer date in April for similar easing of the Rems acro monitoring requirements in the U S. Let's turn of hematology on slide 14 rebels out delivered more than seven.
Speaker Change: The percent growth, reflecting solid uptake across first and second line M. D. S associated anemia patients sales in the U S benefited from demand and included one time gross to net benefit outside U S. Rebozo sales more than doubled driven by demand across newly launched markets in Europe, and a strong launch in Japan in cell therapy beyond these fourth quarter sales more.
Speaker Change: <unk> 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 Citic, two grew more than 30% U S sales benefited from higher demand tempered by gross to net impacts from higher rebates associated with expanded access coverage starting in 2025.
Speaker Change: 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 sort of tick through specifically this will temper our reported sales in the first half of the year.
Speaker Change: Until demand volume can offset these impacts our wrap up reviewing our performance for the quarter on slide 16, with neuroscience and Trabelsi da Vinci sales in the fourth 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 pay.
Speaker Change: <unk> and physicians has been favorable highlighting the benefits of <unk> 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 fourth quarter, driven primarily by product mix, excluding in process R&D operating expenses increased approximately 8%.
Speaker Change: Largely driven by R&D investments, partially offset by our ongoing cost savings program regarding our operating expenses, we made significant progress during 'twenty 'twenty four against our 1.5 billion dollar strategic productivity initiatives. After the end of the fourth quarter, we realized approximately $1.1 billion in savings and expect the remaining $400 million would be realized in 2020.
Speaker Change: Five.
Speaker Change: 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.
Speaker Change: It 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 31st we generate strong cash flow from operations of approximately $4.4 billion in the fourth quarter in terms of capital allocation we can.
Speaker Change: Tinian 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 'twenty 'twenty four we have repaid approximately $6 billion of the $10 billion of debt, we committed to pay down relative to our March 31, 2024 balance our capital allocation priorities also include returning cash to.
Speaker Change: <unk> shareholders through our commitment to the dividend 20 twenty-five marks are 93rd consecutive year of dividend payments on slide 19, I'll provide more detail on our expanded strategic productivity initiatives that Chris mentioned earlier building on the work we did to capture cost savings last year, we identified additional opportunities to streamline operations further leveraged.
Speaker Change: 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 initiatives savings will be driven by changes.
Speaker Change: 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.
Speaker Change: Couple areas of the business in contrast to the initial 1.5 billion dollar cost savings program, where savings were mainly reinvested. This expanded program will see the incremental $2 billion in savings dropped 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.
Speaker Change: And let me walk you through our non-GAAP 2025 guidance on slide 20, starting with revenue as Chris said earlier, we estimate revenue in 2020 five to be approximately $45.5 billion, primarily reflecting a near term impact of generics across multiple products and the continued strength of our growth portfolio, we expect an 18% to 20% decline.
Speaker Change: Align in the legacy portfolio due to the stacking of Eloise 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.
Speaker Change: 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 expect.
Speaker Change: <unk>, Oh, I any 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 <unk>.
Speaker Change: 25, 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 eloquence as I said earlier, we expect <unk> revenue for the remaining core.
Speaker Change: There's a 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.
Speaker Change: 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 'twenty 'twenty four 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 right sizing our cost structure. We also look forward to multiple.
Speaker Change: Data catalysts, which will accelerate over the next 24 months and we 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: Thanks, David and Chris for the prepared remarks, Alison can we please poll for questions.
Alison: Sure and we will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.
Speaker Change: If you are using a speakerphone please pick up your handset before pressing the keys.
Speaker Change: Your question. Please press Star then two at this time, we will pause for a moment to assemble our roster.
Speaker Change: The first question today will come from Chris Schott of J P. Morgan. Please go ahead.
Chris Schott: Great. Thanks, So much just two quick ones for me first on carbon fee seems like feedback and coverage dynamics are progressing well can you just elaborate on how youre 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 the.
Chris Schott: Space I'm trying get a sense of like the ramp how youre thinking about it for 25.
Chris Schott: 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 low cycle, whereas it's going to really put the company in the.
Chris Schott: The right place as we think about the longer term model and longer term business. So basically kind of thinking about it is the 27 run rate kind of a good way to think about this or is there another step down as we head into Ela question Opdivo. Thank you.
Speaker Change: Thanks for the questions, Chris I'll have Adam take the first question then I'll take the second.
Speaker Change: Great. Thanks, Chris So in regards to <unk>, we're very pleased what we're seeing with co bank fee with three months post launch and the launch is really off to a strong start we're now at approximately a thousand tier access per week.
Speaker Change: And we made very good progress achieving our access so for Medicaid and Medicare were tracking ahead of our expectations, we've achieved over 90% Medicaid access.
Speaker Change: And over 80% Medicare access recall those too.
Speaker Change: Payers represent over 80% of the covered lives in this category and as expected the majority at one step at it post generic we're also making very good progress with commercial payers.
Speaker Change: The feedback over the last several months has been very positive and a lot of enthusiasm around the efficacy and safety profile.
Speaker Change: Also pleased with the number of trailers that were seeing since launch and we have an opportunity to further expand and increase adoption with roughly 30000 psychiatrist so.
Speaker Change: 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 these differentiated profile and we're breaking reflexive prescribing habits and that is going to take some time. So we would expect to see continued strong uptake through 2025, as we said with a ramp in.
Speaker Change: The back half of this year, but taken together.
Speaker Change: We are really pleased what we're seeing so far and we plan to make this a very big product for the company over time, 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.
Speaker Change: Investing in the pipeline both the late stage pipeline as well as promising early areas of science and then maybe just give you two quick vignettes on that.
Speaker Change: We plan to initiate seven phase III program, starting this year on <unk> clearly illustrating that we will 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 <unk> Opdivo and bring on these so <unk>.
Speaker Change: And growth is a priority for us and that's a top priority.
Speaker Change: 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 allo is we think that it makes it.
Speaker Change: 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.
Speaker Change: This is an extension of last year's program that gives us more financial flexibility that financial flexibility ability gives us strategic flexibility and but we're always going to be focused on ensuring that we've right sized the organization. We've got the right level of spend given where the businesses.
Alison: Thanks, Chris Alison can we go to our next question.
Speaker Change: The next question will come from Luisa Hector of Bahrenburg. Please go ahead.
Luisa Hector: Hello, Thank you for taking my questions.
Speaker Change: I just wanted to check your euro assumption.
Speaker Change: Part D redesign if you can quantify it.
Speaker Change: In 2025.
Speaker Change: Ben.
Speaker Change: Just an update on some Bakken that fit on site at any update on the filing plans that thank you.
Speaker Change: Thanks for the question Louise.
Speaker Change: I'll take both of those questions.
Speaker Change: Thanks, Louisa and good morning, as it relates to part D redesign there are pushes and pulls.
Speaker Change: Overall, we are going to see favorability with <unk> due to the elimination of the coverage gap and with that we're not going to see the historical dynamics, we our quest where first half sales.
Speaker Change: <unk> been higher than the second half sales in fact, we're going to see in Q1 is going to be the lowest quarter sales for <unk> at mid single digit sequential growth from Q4 to Q1 globally and we'll see second half sales to be higher than first half sales, but for the full year, we expect strong year on year growth for all the questions.
So when you look at products like Revlimid palm lists to rent and Cam diodes. For example, that's going to offset the aliquot favorability as we see increasing gross to net pressure starting in Q1.
Speaker Change: As patients enter the catastrophic phase and as you know were responsible for 20% in the catastrophic phase and 10% in the initial coverage phase, but as we've said previously we are projected to be roughly net neutral across our portfolio. This year.
Speaker Change: As it relates to used in Dhaka, Matt.
Speaker Change: Given the data that we have seen we've made the decision not to commercialize <unk> 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.
Speaker Change: Essentially transformational outcomes for patients. So we made a similar decision late last year with symposia in U C. As we saw the Kestrel trial in Crohn's disease, and based on our competitive position with Chipotle in IBD, we made that decision as well.
Speaker Change: Thanks, Adam next question please Jonathan.
Speaker Change: The next question will come from Geoff Meacham of Citi. Please go ahead.
Geoff Meacham: Great. Good morning, guys. Thanks, so much for the question I had another one on <unk> I know, Chris you highlighted the expansion opportunities on slide six I guess are there others that you could add or accelerate.
Geoff Meacham: Beyond what you have I guess the main question is since the them rapidly and failure are there changes to the investment plan that youre contemplating.
Speaker Change: And then on the policy front wanted to get your perspective.
Speaker Change: As a as RFK Jays nomination or a confirmation looks I think fairly eminent what are the potential puts and takes on an IRR a revisions obviously been a lot of chatter on what discount and could look like in the outer years. Thank you.
Speaker Change: Sure I'll take the first part of that question and then turn it over to summit and Adam and then.
Speaker Change: I'll come back and talk about the policy, but just let me give you a top line on <unk> obviously.
Speaker Change: The competitive dynamics and changes on the competitive front have an impact in 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 provide them more significant long term opportunity for us.
Speaker Change: 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 Simon I don't want to comment yeah, absolutely true what Chris just said because if you think about the dual.
Speaker Change: Muscarinic agonism mechanism of action that <unk> carries it opens up the door for <unk>.
Speaker Change: Investigating 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 continuing to look into our pipeline what other molecules we can bring forward.
Speaker Change: In the neuropsychiatric space to be able to manage the unmet medical need that exists for these patients at this time.
Speaker Change: I'll just add summit, our focus has been on ensuring a successful launch where generics.
Speaker Change: Typically about 80% market share and Cove, NV has significant safety and efficacy advantage there.
Speaker Change: As Tom just mentioned, we see the unique efficacy advantages around the three domains in schizophrenia hitting.
Speaker Change: Hitting on positive symptoms negative symptoms and cognition due to its unique mechanism of action. So we didn't expect competition from other muscarinic since schizophrenia until late 2006 early 'twenty seven and the failure of an rapidly and we have a clear path forward in schizophrenia, and we're excited about the opportunity with <unk>.
Speaker Change: And we believe that we're going to drive meaningful growth I'll come back to you really into the middle of the next decade 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 Trumps administration.
Speaker Change: <unk>, including nominees like RFA 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 insuring 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.
Speaker Change: And so that's going to be our focus as a company with respect to Iras, specifically I do think there is an opportunity for us to address in the coming administration.
Speaker Change: Some of the challenges is one of the first companies to go through the IRI price setting process. We've been very clear on concerns that we have without law and we see the need to have a number of fixtures 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 build an aldi and <unk>.
Speaker Change: Addressing the spillover impact as two of the most important areas that will 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 alright.
Chris: Alright, Thank you Chris.
Allison: Next question please Allison.
Speaker Change: And the next question will come from Kurt She battani of Goldman Sachs. Please go ahead.
Speaker Change: Thank you and 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.
Speaker Change: Advancements have timelines in terms of data Readouts and Theres also been an absence of slippage across integrating aspects of the pipeline that are very important what are the keys and European to be able to deliver on this.
Speaker Change: Progress in particular, the advancement of timelines.
Speaker Change: Maybe I'll start and then turn it over to summit.
Speaker Change: Chris you correctly pointed out there's 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.
Speaker Change: 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.
Speaker Change: 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 in some of his team has done a nice job of helping us do that so Simon you want to comment on specifics yeah, absolutely. Thank you for the question Chris.
As Chris has said the laser focus is the start but then again following the principles we laid out.
Speaker Change: A few years back in fact between Robert myself from the research and discovery perspective, the causal biology to discover the drugs matching the modality to them mechanisms and then picking the right diseases and then after that accelerating that proof of concept generation, but then if you look at the late development, we broke down the process into multiple pieces.
Speaker Change: Dig deeper into where we were doing well that is a variant of 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.
Speaker Change: The 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 bulk most amount of scientific rigor was there to be able to achieve the proof of concept and one that was achieved how do we then accelerate that into generation of the data to bring.
Speaker Change: The drug to the patients and to end two of commercialization all of that has helped in the examples that right in front of you last year, we were able to accelerate and deliver the psoriatic arthritis data early this year, we will be able to give games iOS data early this year, we'll be able to bring in adapt and now we are working on the next drive as well as we think about multiple myeloma.
Speaker Change: SBA one in IPF SLE trials for <unk> and of course that mindset will go in all of these seven drives that we've talked about for <unk> as well. So overall very pleased with the progress we've made but we have a little bit more distance to go and we will continue to focus on our portfolio to deliver that and just to put a finer point on what Simon said Chris.
Speaker Change: We have the potential for 15 or more registrational trials that will read out by the end of next year.
Speaker Change: So the work that Tom its team is doing to ensure that those are delivered delivered on time as we think critical and we've made good progress in 2024, and as Amin said, we're heads down and continuing to execute on that.
Speaker Change: Great. Thank you, let's move to the next question. Please.
Speaker Change: And the next question will come from Tim Anderson of Bank of America. Please go ahead.
Tim Anderson: Alright. Thank you very much I have a couple of questions.
Tim Anderson: So the revenue guidance for 25 is about 1 billion less than consensus and as much as you've looked at consensus where are you seeing the biggest differences could <unk> be one of those contributors of the delta.
Tim Anderson: And then a longer term question on earnings in the past, Chris you've suggested trough earnings.
Tim Anderson: It would really be in the very late 2000, Twenty's and to me it felt like maybe 2028 2029.
Tim Anderson: Is that still the right way to think about it.
Tim Anderson: And could a product like <unk> or some of these other programs.
Tim Anderson: Possibly pull that forward.
Tim Anderson: Thanks for the question Tim.
Tim Anderson: Maybe I'll start and then.
Tim Anderson: Turn it over to David for the first part of your question and then I'll come back for the second part.
Tim Anderson: 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 low exposure that we have as a company as expected this year, we're seeing the.
Tim Anderson: Increased stepped down on revlimid as well as the stacking of full year impact of products like <unk>, which lost exclusivity in Europe as well as in the U S price on a vaccine 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 felt good about the progress.
Tim Anderson: And that we're making on the new product portfolio and then as we discussed in the last question. We have is in.
Speaker Change: 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 LOE guidance.
Tim Anderson: Tim Thank you for.
Tim Anderson: The question and just as a reminder, you bloomberg's for the total company sitting around 46, two we're guiding approximately $45 five if you remember in my prepared remarks that there was 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 were broadly in line with where it is.
Tim Anderson: Minor differences is really as we keep.
Tim Anderson: Highlighting is around the legacy portfolio in particular, rather make coming down to two two and a half as well as the other generic impacts that we mentioned on the call, but overall, we feel pretty good where we are versus consensus with respect to the trough question.
Tim Anderson: First I think the way Youre thinking about the drop 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 of course. This reflects the philosophy that we have that we're going to guide to what we and you can hold us accountable for.
Tim Anderson: We've also been very clear on is that our focus continues to be on driving top tier.
Tim Anderson: 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 of the depth and duration of that and how we do that is to continue to do more of.
Tim Anderson: What we frankly did last year dry brain growth brand performance accelerate the pie broad 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 Corona to bring a product like <unk> into the portfolio.
Tim Anderson: 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, and 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.
Tim Anderson: We're going to be.
Tim Anderson: Transparent about our performance against on these calls alright, Thank you Chris Hello Allison.
So let's move to the next question.
Speaker Change: Our next question will come from Mohit Bansal of Wells Fargo. Please go ahead.
Mohit Bansal: Great. Thank you very much.
Speaker Change: For taking my question.
Speaker Change: My question is regarding <unk>, so I mean.
Speaker Change: There was some thought about illiquid getting something because the body is that given that.
Speaker Change: There's more donut hole now and.
Speaker Change: Maybe they'd like given the price point the impact of body design may not be a large so in the context of that how are you thinking about the growth for this brand for this this year. Thank you.
Mohit Bansal: Thanks for the question Mohit, Adam you want take that demo it. Thanks for the question as I mentioned.
Mohit Bansal: We're going to see favorability, we now look worse this year in the U S. Due to part D redesign with the elimination of the coverage gap.
Mohit Bansal: And so I talked about the dynamics historically, where in 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 <unk> and we will see higher sales.
Mohit Bansal: In the second half of the year for the year, we expect strong double digit growth for <unk> overall, and when we look at where we are position in the market in the U S. We have a market share that continues to grow linearly our share in the U S. <unk> is roughly 75% and we know that.
Mohit Bansal: <unk> out of the market, we've got a great opportunity to continue to drive this important brand for the company.
Mohit Bansal: Right.
Speaker Change: Thanks, Adam next question please.
Next question will come from Trung hung of UBS. Please go ahead.
Trung Hung: 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.
Trung Hung: 2025, you touched upon one key dynamics, but should we just follow the Revlimid step downs for the year is there any other considerations that we should think about here.
Speaker Change: And then just wondering if you can give us any early insights into the access and coverage of Opdivo can take and any thoughts on the uptake for 25. Thanks.
Speaker Change: Thanks for the questions from David You will take the first one then Adam you can come in on the second.
Speaker Change: And as you said.
Speaker Change: Does it step down will be mainly driven by Revlimid and <unk>.
Speaker Change: Volumes coming through with those gross margins being slightly higher.
Speaker Change: Than the average and the only other consideration obviously is Alex question I think is.
Speaker Change: Adam had covered typically Alex was larger in the first half of the year than the second half of the year. This year, that's going to be inverted and that our lowest quarter for electricity 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.
Speaker Change: Yes, so as it relates to Opdivo <unk>. These are very early days the teams out in the field educating healthcare practitioners on the benefits of sub Q versus IV. As we said previously we believe physicians will convert at least starting to 40% of the <unk>.
Speaker Change: Ivey business ahead of our low in late 2028, which will extend the franchise into the 20 <unk>.
Speaker Change: We have seen so far.
Speaker Change: Very positive feedback early on is around.
Speaker Change: Usage in adjuvant patients patients who are treated in combination with <unk> in first line metastatic melanoma first line RCC.
Speaker Change: The feedback specifically have been positive regarding the three to five minute infusion time, we're taking off that treatment burden for both physicians and for patients. We've also seen a number of mtc and guidelines updated or your reimbursement question too.
Speaker Change: Include Opdivo Keybanc within just a few weeks after approval.
Speaker Change: The most common question that we're getting is around the reimbursement dynamics here and we've had conversion from IV sub Q in the first half of the year, it's 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.
Speaker Change: Good.
Speaker Change: On July one and so we're excited about the launch and what this means for patients physicians and importantly, the durability of our Io franchise alright.
Speaker Change: Alright, Thank you Adam.
Let's go to our next question please.
Speaker Change: Next question will come from Evan Seeger men of BMO capital markets. Please go ahead.
Hi, guys. Thank you so much for taking my question one on BD more specifically now that we're on this side of the muscarinic debate with Kabam, Preapproved and Iraq, but did not turn in advocacy can you walk us through kind of your process in determining why you went for Corona when you want to get into schizophrenia.
Speaker Change: And on kind of a more mechanistic perspective, what's happening with tims, obviously saw a nice step up what are you seeing in the field that's driving the uptake there. Thank you.
Speaker Change: Thanks for the questions and then I'll start and then turn it over to idle there.
Speaker Change: No magic bullet with respect to how you approach business development from from our standpoint, but I think there were a few things that we.
Speaker Change: We did well with the Corona acquisition that will frame, how we continue to do business development first I would note that the senior leadership team of the company owned to the decision to move forward with that acquisition capital allocation is critically important as we discussed business development is a top priority for us as a key.
Speaker Change: 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 started with.
Speaker Change: Sure when we really like the science, we considered multiple options and we zeroed in on the science that was coming out of Corona as.
Speaker Change: Compelling in our view and beyond that we felt strongly that that had an opportunity to strengthen our therapeutic areas as well as to gives 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 and that it would add value.
Speaker Change: The company and ultimately to shareholders you actually saw how we executed against that post the decision to acquire.
Speaker Change: And that we spent a lot of time with the heritage Corona team too.
Speaker Change: Fully develop this asset in ways that they were unable to do so and we think thats 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.
Speaker Change: And so those lessons I think we'll frame out how we continue to do business development at the company.
Speaker Change: And then Adam do you want to take the second question, Yes, Evin regarding campus Iot we've seen strong.
Speaker Change: And consistent growth from <unk> as you heard from David's opening remarks.
Speaker Change: And 2024, there were approximately 12000 patients in the hub and roughly 9500 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 were continuing to add new patients each and every week. So our.
Speaker Change: <unk>.
Speaker Change: It is now on increasing depth of prescribing in the larger coes, while at the same time, increasing breadth and some of the smaller institutions and larger community practices and we're making some good progress there.
Speaker Change: We also have.
Speaker Change: Couple of things David mentioned, one we look forward to the <unk> date.
Speaker Change: That's coming in April so similar to what we've seen in Europe. Our goal is to ease the burden of eco requirements for patients and physicians and we expect that to open up additional capacity at the Coes and as a result of physicians to be able to treat more patients.
Speaker Change: 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.
Speaker Change: 30% or so and so that's going to allow cams iOS tablet nice first mover advantage in both indications and across the full spectrum of patients with symptomatic HCM.
Speaker Change: Thank you Adam let's take our next question. Please.
Speaker Change: Our next question will come from a cost Kumari of Jefferies. Please go ahead.
Kosi Kumari: Alright, thanks, so much so what's the risk around the adjunct because if any child for Quebec fee, because we haven't seen a lot of companies run that specific trial and if they have they are often failed.
Kosi Kumari: So why wouldn't the probability of success for this trial being more like a 50 50 quite flip and on the <unk> label update are you aiming for six months Echo monitoring requirements and if so how do you think that will help expand access into the community setting. Thank you.
Kosi Kumari: Thanks for the question Summit, then Adam Yes sure. Thank you for the question on the Adjunctive schizophrenia, remember, where we started off in how patients are treated in the in the real world. So we obviously have developed the drug as a monotherapy, but these patients who are primarily.
Kosi Kumari: <unk> got onto the trial, we're receiving the <unk>.
Kosi Kumari: Agonists and thereafter, there was a washout period patients came on the drug and then of course to drive value to the primary endpoint in an emerging one two and three at the shorter window, but remember at emergent thoughtful and Pfizer now read out with a 52 week follow up many of those patients. Obviously are also taking concomitant medications in the background.
Kosi Kumari: So and we've seen that efficacy continued 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 drug and of course Oh.
Of that we will look at.
Kosi Kumari: Adapt trials also reading out beginning at the backend of this year coming to Kim's iOS.
Kosi Kumari: 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 patient and the treating physicians and from that perspective. It was important the data that we've collected from the real world as well as in the clinical trials suggests that that overall safety profile of kindergartens maintained many of the patients are treated actually at the lowest dose.
Kosi Kumari: Two 5% and five milligrams and considering all of that data is.
Kosi Kumari: <unk> 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 that goes as we look to the U S.
Kosi Kumari: Reviews, as well Adam if you want add anything.
Kosi Kumari: Just adding just one bed and pointing you to the.
Kosi Kumari: The European label. The label was updated late last year to reduce the frequency of echo monitoring for patients taking <unk> from every 12 weeks to once every six months when patients are in the maintenance phase after a 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.
Kosi Kumari: And as a result physicians will be able to treat more patients.
Speaker Change: Thank you both so let's move to the next question. Please.
Speaker Change: Next question will come from Terence Flynn of Morgan Stanley. Please go ahead.
Terence Flynn: Great. Thanks for taking the questions maybe two for me.
Terence Flynn: David I just wanted to clarify on the the new productivity initiatives should we think about the run rate for year end 2007, as being 15 billion.
Terence Flynn: So an incremental billion dollars off of the 16 now just wanted to make sure I understood. It correctly and then on <unk>.
Terence Flynn: The addition of the <unk> endpoint.
Terence Flynn: Did the FDA sign off on that and if so.
Terence Flynn: Are you able to get approval on just in MLD 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 that Marty. Thank you.
David Elkins: Thanks, Darren David in summit.
David Elkins: Thanks for the question, Yes, you have that right. So.
David Elkins: Incremental to $2 billion program all of that dropping to the bottom line instead of $1 billion of that would drop this year with operating expenses of $16 billion to further $1 billion achieved by 2027 would get you to operating expenses of 15.
David Elkins: In terms of thinking about Alberta might of course quite excited that based on the discussions that you probably followed from the <unk> setting perspective, Mardi as an endpoint is more and more becoming important because.
David Elkins: 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. That's why newer endpoints are needed. So of course, we have discussed with the FDA. The ability to include MRV as one of the primary endpoints in the clinical trial.
David Elkins: And we'll certainly be the 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.
David Elkins: We will observe at the end of the day. 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 a second primary endpoint within the drivers also of course, the patients will be followed for PFS and as well as the secondary endpoint, which is overall survival as well. So we are going to come.
Speaker Change: Maxim of data from the clinical trial and engage the authorities based on the magnitude and the timing of the readout. Thanks, Amit the only thing I would add David David got it right with respect to how the cost savings will flow.
Speaker Change: 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 as framing all of this discussion around around cost alright. Thank you.
Speaker Change: Let's move to our next question please.
Speaker Change: Next question will come from Courtney brain of Bernstein. Please go ahead.
Courtney Brain: Thanks, So much for taking my call my question today in the call.
Courtney Brain: Two parts I think you spoke a little bit about business development and then answer this flooring and restaurants that is the top priority from a capital allocation perspective can you just talk a little bit about.
Courtney Brain: Ta alignment kind of what good looks like particularly in the context of your organization you have right now I think last year was a little bit of digesting the deals that you've done quickly.
Courtney Brain: Wanting to understand kind of how you're thinking about that appetite now and then of course and then the second was just around kind of condensate and specifically kind of gross to net evolution as we're thinking about this access involving from kind of initial private pay to more of that of the government setting to then adding on a little bit of the commercial environment.
Courtney Brain: It would be very helpful.
Courtney Brain: And how you're expecting that to flow. Thank you.
Speaker Change: 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.
Speaker Change: The way, we think about therapeutic areas is that were really focused on strengthening our position in the core therapeutic areas that we have today.
And that that we can do by bringing promising areas of science into the company.
Speaker Change: 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 in the way we think about it is that we need to like the science and feel that we are the rightful owners of it the financials have to make sense and again.
Speaker Change: Included in that thinking strengthening the growth profile is a key factor we are considering and.
Speaker Change: We have to believe that we can drive value for the company and ultimately for shareholders and as we look across our core therapeutic areas that we have today, we see opportunities as we see opportunities to.
Speaker Change: 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 with that.
Speaker Change: Financial strength and flexibility gives us strategic flexibility and that flexibility includes doing business development, where it makes sense.
Chris: Thank you Chris.
Speaker Change: Alright.
Speaker Change: I'll just answer the question around with us for that coordinate thanks for the question relates to gross to net the brand is going to continue to lean heavily towards the.
Speaker Change: The public sector, Medicare and Medicaid when you think about the.
Speaker Change: The evolution of schizophrenia, if any indications or our Alzheimer's indications, whether it be Alzheimer's disease psychosis, and Alzheimers cognition and these are patients who are going to be in Medicare and Medicaid.
Speaker Change: Commercial patients are less than 10% you will see that more commonly in some of the indications such as.
Speaker Change: Autism and bipolar disorder, but the majority of the brand will largely be in the public sector, where there are.
Speaker Change: Medicaid best price.
Speaker Change: Thanks, Adam let's move to the next question. Please.
Speaker Change: Next question will come from Seamus Fernandez of Guggenheim Securities. Please go ahead.
Seamus Fernandez: Oh, great. Thanks for the question. So just quickly on <unk> I was hoping you could talk about the patient.
Speaker Change: Patient experience that you're seeing so far in the field.
Speaker Change: We know that patients certainly feel better cognitively, but there are questions around the tolerability.
Speaker Change: And the dosing so just interested to know if there's any early.
Speaker Change: Fine.
Speaker Change: You know sort of the durability.
Speaker Change: And how you're managing the.
Speaker Change: 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 <unk>.
Speaker Change: Novel oral drugs like a bird of minor music to my.
Speaker Change: Could appropriately fit within the context of.
Speaker Change: The overall multiple myeloma market.
Speaker Change: Given the availability of generic Revlimid and panelists.
Speaker Change: Thanks, Seamus, Adam and then maybe something in China as well, yes, Seamus thanks for the questions.
Speaker Change: We've been really pleased with what we're hearing from both physicians and patients the feedback has been very positive.
Speaker Change: With a lot of enthusiasm on the efficacy and the safety profile. So what we're hearing is patients are seeing improvement in positive symptom as early as the first week of treatment and on really the lowest dose of 50 milligrams.
Speaker Change: And we're also hearing good successes on negative symptoms and you know what we 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.
Speaker Change: The aes.
Speaker Change: What we've heard from physicians they are manageable included 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 starting with 50 milligrams, they're taking a week or two before they titrate up to the next dose is at 100. Unlike what you saw in the <unk>.
Speaker Change: Clinical trials, which moved to 125 milligrams within the FERC eight DS.
Speaker Change: Of the trial, so that has been incredibly positively received.
Speaker Change: So we're not hearing a lot of the the G I.
Speaker Change: Top tolerability issues from from physicians, but our teams are out there, making sure that we're educating on what to expect as it relates to <unk>.
Speaker Change: We know that on average patients are on seven pills per day and so we're not hearing this has a major objection to prescribing and last thing I mentioned is we've got an ongoing study looking at taking <unk> with food that will read out. This year that will also improve the ease of prescribing for physicians and make it easy.
Speaker Change: Year for patients as well so I'll just take it from there and one thing that I would just add on Coventry. So prior to <unk>, what drugs are doing with treating the symptoms of schizophrenia, meaning the positive symptoms by Medicare.
Speaker Change: <unk> now we are treating schizophrenia meeting also impacting the negative symptoms and we are seeing the impact on cognition as we've recently published data on multiple myeloma switching gears. It is important to understand where the patients are treated and what the drugs that are available. If you think about the cell therapies and the T cell engages a bi specifics they ought to be primarily <unk>.
Speaker Change: Using the academic center settings, whereas most of the patients with multiple myeloma, especially with relapse refractory disease are being treated in the community setting where it is it is very difficult to get these therapies.
Speaker Change: Therapies that the side effect management in the Rems program that go along with them and Thats, 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 what I Britta mind music, they might fit and <unk> is being compared head to head versus <unk> and that's how you would replace some of that it might and then of course there is.
Speaker Change: Other trial looking head to head, Alberta might versus <unk> with certainly with readout later, but it is a very important component of the overall development plan.
Allison: Thanks, Amit next question please Allison.
Speaker Change: Our next question will come from David Ross <unk> of Leerink partners. Please go ahead.
David Ross: Yes, thanks, very much and congrats on all the updates.
Speaker Change: Thank you.
Speaker Change: Sorry, I have another call coming in here so.
My apologies.
Speaker Change: They want me they want me on the box to speak so I have two questions first with respect to the performance and twenty-five. So obviously the worst that the eloise perform in 'twenty five the better the setup for the trajectory of growth for the company in 2000.
Speaker Change: Six but its the loss of exclusivity products.
Speaker Change: Performed better than expected then it makes it a little bit tougher to grow in 2006 could you just discuss that a little bit and provide some initial context for 2006, I know that youre not providing guidance at this time and then second just with respect to your voice, it's been performing very strongly.
Speaker Change: <unk> growing 20% roughly in the fourth quarter and.
Speaker Change: Roughly 20% for full year 2020.
Speaker Change: Five sorry, 2024 can you comment on gross growth prospects for your voice going forward as well. Thank you.
David Elkins: Thanks, David David Elkins and Adam.
Speaker Change: So just on your question around 25 minutes.
What to think about heading into 'twenty six.
Speaker Change: First.
Speaker Change: Revlimid as we said we have additional generic entry coming so about 70% of the market will be supplied by generic remember for Revlimid full generic entry in January of 2006, So we'll be through that by the end of the year and we have generic entry of <unk> next year as well and the only other headwind that I would mention is we provided.
Speaker Change: Guidance on higher array, which really took out the worst case scenario for us as we head into the IRA in 'twenty six 'twenty seven but really our focus remains on investing in the growth drivers you saw the strong execution in that growth portfolio that is now greater than 50% of our business. We exited a double digit growth last year, we feel really good about the position that we're in.
Speaker Change: This year.
Speaker Change: And then as you think about going into 'twenty six with that group portfolio you heard him talk about the additional indications in <unk> too.
Speaker Change: As well as <unk>.
Speaker Change: We got some really important data readouts that we're going to be able to add up to six new enemies 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 prudency further adding to that growth portfolio. So theres pushes and pulls there, but what's becoming clear is.
Speaker Change: The strength of the growth profile as we go into the second half of the decade here.
Speaker Change: As it relates to <unk>, we're seeing solid demand growth across our core indications first line lung first line RCC as well as the first line melanoma, where you have always used in combination and that growth is coming both from the U S and from our international markets in the U S. We continue to see good adoption in the community and as you know last year we.
Speaker Change: Presented I think is remarkable 10 year long term data in first line melanoma I think the last thing I think is we're also preparing for launches. This year in first line HCC and first line MSI High Crs.
Speaker Change: CRC both in combination with <unk>, which will help drive your performance and we also have Opdivo you avoid long approval that's pending in China. So taken together, we would expect continued growth from <unk> 25.
Speaker Change: Thanks, Adam.
Speaker Change: Take the next question please.
Speaker Change: Next question will come from Matt Phipps of William Blair. Please go ahead.
Matt Phipps: Thanks for taking my questions following up on the <unk> primary endpoint for the Alberta <unk> trial.
Speaker Change: Is there a time course of the FDA wants as far as how much durability on that MRV and why not add Mardi endpoints to the MS. Victimised trials. It does look like you already have MLD on the Arlo, So quintessential too and then similarly in multiple myeloma is there a point at which the BEC or does it kind of the profitability breakpoint for a bank.
Matt Phipps: And the success of Arlo, so really kind of.
Matt Phipps: The need for Beckman thinking.
Matt Phipps: Thanks, Matt and Summit, then Adam Yes, sure. Thank you Matt for the question. So for multiple myeloma looked at Mardi endpoint is something that is new from the perspective of using as a registration trial endpoint and Thats why we have to continue to follow the patient central wide. The durability in terms of not only <unk>, but also overall response.
Matt Phipps: <unk> CR rate that we will see and this 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 Alberta might trough 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 <unk>.
Matt Phipps: Earlier, MRV endpoint readout to clear the development of 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.
Matt Phipps: Current 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.
Matt Phipps: As it relates to our back.
Matt Phipps: Myeloma can remain a very crowded and competitive space and there are multiple treatment options available we remain committed to that number 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 it back and we're going to remain competitive in the space as you heard earlier from Chris and David.
Matt Phipps: We're very excited also about <unk>, which we believe is going to play a critically important role in the treatment.
Matt Phipps: Post <unk> car T with a single infusion and an improved safety profile.
Speaker Change: Thanks, Adam.
Speaker Change: So let's take our next question please.
Speaker Change: Next question will come from Stephen scale of TD Cowen. Please go ahead.
Stephen Scale: Thank you so much I have two questions first Bristol's second generation tick two completed phase two in psoriasis in August of 2024, but hasnt progressed.
Stephen Scale: So curious what the profile of this agent is what are plans and as IBD within those plans and secondly mill vaccine phase III readouts in stroke and Acs are expected in 2026, but later in the year curious if events are tracking for that 2026 readout.
Stephen Scale: And is there any possibility at all for a 2025 readout for either trial. Thank you.
Speaker Change: Thanks Gene summit, Thanks, Steve for both the questions. So first of all for the back uptick two we completed those studies, we have the data, but as you know we are continuing to progress.
Speaker Change: Overall clients towards particularly at this time and as we spoke earlier, we have to decide it within our pipeline, where we are going to really focus and prioritize and at the current time, our focus is truly squarely on Sofia, two and maximizing that opportunity from a development and commercial perspective. So at this time that take two is not in the development as you already have stayed.
Speaker Change: It from the SSP in Acs readout events are tracking as well as the enrollment is going really well, we do not expect that to read out in 2025, we expect that read out as we have stated at the backend of 2026.
Speaker Change: All right. Thank you Charlotte next question. Please.
Speaker Change: Next question will come from creep at the bar conduct of tourists Securities. Please go ahead.
Speaker Change: Hey, guys. Thank you so much for taking my question I Hope it comes out of the question Congrats on getting the label update in EU.
Speaker Change: I was wondering what the label change in EU and potentially a change in the U S right.
Speaker Change: How do you see the peak opportunity now.
Honesty data upcoming this year can you help set expectations for the readout and then if I can.
Speaker Change: One in scoop.
Speaker Change: <unk> one of the Kols. We recently spoke to said that there was an issue agenda visibility.
Speaker Change: Pharmacy with what he said I was wondering if this is just a one off or is it does it just take time to ramp up availability. Thank you.
Speaker Change: Yes, so I can certainly take those but thank you so as it relates to the label for <unk>.
Speaker Change: As I said, we expect.
Speaker Change: Just have a <unk> date in April of this year and our goal is to continue to ease the burden of the eco requirements for both patients and physicians and it's going to open up additional capacity at the Coes. What we are seeing for our campus iOS, which is consistent.
Speaker Change: Consistent and steady growth, we have a very large revenue base is building and we continue to expect growth from the expansion of prescribers.
Speaker Change: At a high persistency patients are staying on treatment for very long time, they are feeling better and so that's good.
Speaker Change: 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 some it if you want to talk 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 is positive around a third of patients.
Speaker Change: In HCM and have an opportunity to build upon the success of <unk> 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 summit to talk a bit more about an HCM and then I'll quickly answer your <unk> question.
Speaker Change: Yeah I'll address the Odyssey question very quickly the paper from a methodology perspective as well as the baseline characteristics of the patients who had just publish and JCB heart failure. So you can certainly pick it up from there and the primary endpoints of <unk> NPV or two are well described as well as the statistical methodology is so.
Speaker Change: Of course, we're looking forward to the readout and it's just I think in the next quarter, we will be able to see the results and then we'll share that with you, yes, just really quickly on that.
Speaker Change: Not hearing that our teams are out both with physicians, but theyre also at the pharmacies as well. So I do think that is essentially a one off and we want to make sure that the.
Speaker Change: Quebec is available broadly across the U S. So patients can get access to this really important product. Thanks Adam.
Speaker Change: Go to our next question please.
Speaker Change: The next question will come from Olivia Brayer of Cantor Fitzgerald. Please go ahead.
Olivia Brayer: Hey, good morning. Thank you for the question what data did you submit to the FDA for the less restrictive rems.
Speaker Change: Does that include anything additional versus what was submitted to EMA.
Speaker Change: And are you asking the agency for the same two updates that were proposed in the AR and the December agenda, I think those are around <unk>.
Speaker Change: Monitoring frequency and they use a L V O T gradient.
Speaker Change: Adam I just wanted to clarify one point you made earlier you said.
Speaker Change: The European label is updated to reduce frequency I think he said from every 12 weeks to once every six months just wanted to clarify that I heard that correctly.
Speaker Change: Thanks, some of them 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.
Speaker Change: 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 was submitted that they come from both clinical trials as well as from the real world evidence of overall data package was very strong and we continue to have the dial.
Speaker Change: But the regulatory agencies.
Olivia Brayer: Olivia just to clarify again the label in Europe was updated to reduce the frequency of echo monitoring for patients taking <unk> post week 12. So after week 12 as patients move into the maintenance phase.
Olivia Brayer: Once a quarter and they're able to now have echoes once every six months.
Adam: Thank you Adam next question please.
Speaker Change: Next question will come from James Chen with Deutsche Bank. Please go ahead.
Adam: Okay.
Speaker Change: Thank you for the question guys I just wanted to follow up on the rise question what are <unk> expectations for the Pan score benefit and then any color on how AD. It too will be disclosed will be NTIC be topline in the PR and will this be followed by a full data set at medical Congresses. Thank you.
Speaker Change: Thank you for the questions. Let me start with the second one for adapt as it has been recently done in previously done.
Speaker Change: At the top line if it reads out we will be putting out a press release, but generally we do not disclose the data read those will be presented at <unk>.
Speaker Change: Medical conference appropriately and for arise again.
Speaker Change: 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 Readouts of both of those endpoints are going to be important apart from the of course, the secondary endpoints right now we're not commenting on the overall magnitude, but here even small.
Speaker Change: The differences in terms of the points would be very very important and clinically meaningful as you know in the neuropsychiatric space right. Thank you Charlotte.
Speaker Change: Next question please.
Speaker Change: Our next question will come from Sean <unk> of <unk>.
Speaker Change: Raymond James Please go ahead.
Speaker Change: 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.
Speaker Change: Blowing that investment in the infrastructure.
Speaker Change: Segment. Thanks.
Speaker Change: Yes.
Speaker Change: Reyes.
Speaker Change: Our portfolio perspective of course, the phase III is already ongoing and GAAP net and this is in the patient population.
Speaker Change: And that has already received prior to the Terra so.
Speaker Change: And certainly the phase one data was very strong and we will continue to look for not only their sponsored 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 and a phase one study and we recently started the breast cancer program.
Well and from the portfolio perspective, we have a we're looking forward to initiation of our phase one program for <unk> 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.
Speaker Change: 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.
Speaker Change: We would consider business development as well.
Chris: Thanks, Chris Operator, we'll take our last question and then we'll turn it to Chris for some closing remarks.
Speaker Change: Next question will come from Alexandra Hamman of Wolfe Research. Please go ahead.
Alexandra Hamman: Thanks for squeezing me in just one bristol's long term growth potential.
Speaker Change: Jim has mentioned an under appreciation for the pipeline can you fly the key asset do you expect to drive revenue and looking at the back end of the decade, maybe your favorite child are too. Thank you.
Alexandra Hamman: Yes, well.
Alexandra Hamman: <unk>.
Alexandra Hamman: 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 <unk>. Clearly we also are very excited about our cell mod programs, we have multiple cell mods that we've spoken about today, Ivor and messy, but we haven't spoken about.
Alexandra Hamman: <unk>, that's a potentially very meaningful product in.
Alexandra Hamman: In lymphoma, and there was actually an important so it's very difficult to pick a favorite child here whenever theres, such a wealth of opportunity in our late stage pipeline and we haven't even talked about the next wave of assets, which include some really exciting opportunities including products like CD 19 next T <unk> in.
Alexandra Hamman: And and prostate cancer.
Alexandra Hamman: As well as others by the way I forgot to mention in the first wave of assets L. P. A one 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.
Alexandra Hamman: And play out and going from there so I think with that.
Alexandra Hamman: Will.
Speaker Change: Close today's call I appreciate everyone's staying on I know, we went a bit long, but hopefully we were 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 catalysts some of which.
Alexandra Hamman: We just discussed we're.
Alexandra Hamman: 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.
Alexandra Hamman: We continue to take decisive action to further rightsize, our cost structure and invest in future growth we believe.
Alexandra Hamman: 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 <unk>.
Alexandra Hamman: 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.
Alexandra Hamman: Yes.
Alexandra Hamman: And part is now concluded. Thank you for attending today's presentation and you may now disconnect.
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