Bristol-Myers Squibb Q4 2024 Earnings Report

Actuate Therapeutics EPS Results

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

Actuate Therapeutics Revenue Results

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

Actuate Therapeutics Announcement Details

• Quarter: Q4 2024
• Date: 2/6/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, February 6, 2025
• Conference Call Time: 8:00AM ET

Actuate Therapeutics (NASDAQ:ACTU), Inc., a clinical-stage biopharmaceutical company, focuses on developing therapies for the treatment of cancers. The company's lead product candidate is Elraglusib Injection, a novel glycogen synthase kinase-3 inhibitor to treat metastatic pancreatic ductal adenocarcinoma. It also develops Elraglusib for the treatment of Ewing sarcoma, metastatic melanoma, and colorectal cancer. The company was formerly known as Apotheca Therapeutics, Inc. and changed its name to Actuate Therapeutics, Inc. in October 2015. The company was incorporated in 2015 and is based in Fort Worth, Texas.

Actuate Therapeutics Q4 2024 Earnings Call Transcript

Presentation

[Operator]

Welcome to the Bristol Myers Squibb Fourth Quarter twenty twenty four Earnings Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Chuck Traiano, Senior Vice President and Head of Investor Relations. Please go ahead.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Thank you, and good morning, everyone. We appreciate you joining our fourth quarter twenty twenty four 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 Lunkowski, our Chief Commercialization Officer and Sumit Herawat, 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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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 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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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 and L are on a non GAAP basis. And with that, I'll hand it over to Chris.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 established as 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 fourth quarter and full year accomplishments. Then I will speak to the promise we see with Cobenphi and the steady cadence of clinical data catalysts that will begin this year, further defining our future growth potential.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 and D milestones. Looking at the full year, let's turn to Slide five. I'm pleased with the progress we have made executing on our multi year plan.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

For the year, the growth portfolio delivered double digit revenue growth led by Briyonzy, Chemsaios, Breblazil and Opdulag. In the latter part of the year, we reestablished our presence in neuroscience with The US approval and launch of Cobinvy, which is the first novel mechanism for the treatment of schizophrenia in decades. We also received US approval of Opdivo Qvantiq 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

As part of this effort, we reallocated significant spend towards high potential growth opportunities, achieving most of our targeted 1,500,000,000 in savings. We expect to capture the remainder this year. Additionally, we put considerable focus in 2024 on improving R and D productivity. As a result, we have been able to accelerate several programs in our late stage pipeline. Notable include CHEMZYOS, where we completed enrollment in the Odysee non obstructive HCM study six months earlier than expected and now anticipate top line results next quarter.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

With Kobenphi, the ADEPT2 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 twenty twenty six. This is due to our focus on accelerating patient recruitment following the acquisition of KORuna. And with our Iberdomide Excalibur trial in relapsedrefractory 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

As a continuation of that, we are taking deliberate steps to become a leaner, more focused company and have identified an additional $2,000,000,000 in savings. We expect approximately $1,000,000,000 of these savings to be realized this year and the remainder by the end of twenty twenty seven. 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 six. The US approval of Coventry and 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 readouts starting this year and every year thereafter for the remainder of the decade.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

This year, we're initiating seven phase three studies across three indications, Alzheimer's disease agitation, Alzheimer's disease cognition, and bipolar one disorder. And next year, we plan to begin phase three studies in autism spectrum disorder irritability. The significant ramp up in spending on CoBinvy illustrates our focus on continuing to invest behind key growth drivers while simultaneously maintaining financial discipline. Moving to slide seven, we are entering a data rich period with multiple catalysts over the next twenty four 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 Kobinci ARISE study in adjunctive schizophrenia.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Then in 2026, we expect to have registrational data for numerous potential first and or best in class medicines, including Milvexion in acute coronary syndrome and secondary stroke prevention, admiralparin in idiopathic pulmonary fibrosis, and mesigdemide in multiple myeloma. We also expect to have registrational data for Arlocell or GPRC5D CAR T in multiple myeloma and for RAYS101 in GEP NETs. We believe these readouts will further de risk 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 eight. In terms of the top line, we estimate revenue to be approximately $45,500,000,000 reflecting, as expected, the near term impact of generics across multiple products and the continued strength of our growth portfolio.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

This includes CoBinpi, 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 twenty four 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, EVP & CFO at Bristol-Myers Squibb Company]

Thank you, Chris, and good morning, everyone. I'll begin my review of our 2024 financial results focusing on our fourth 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.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

Starting with Slide 11, sales in the fourth quarter grew 9% to approximately $12,300,000,000 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 REBIZEL, Briyansi, Khemzias and Optilag 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, SpryCell and POMOLYST. Overall, our performance in the fourth quarter capped off a very good year for our company, making progress in building a foundation for long term sustainable growth.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

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 Qventiq, and we expect low single digit growth for this product and Opdivo taken together.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

With Opdilag, 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.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

Sales benefited from uptake in newly launched markets. Moving to cardiovascular on Slide 13, Eliquis delivered over $3,000,000,000 in fourth quarter sales. U. S. Sales grew 19% benefiting primarily from continued strong demand and the typical inventory build.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

Importantly, as you think about the impact to Eliquis from Medicare Part D redesign, Q1 U. S. 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 Kymsaios, sales in the fourth quarter more than doubled, benefiting from higher demand and a large inventory bill.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

As a standard of care and obstructive HCM, Chemsaios continued to show strong momentum as evidenced by the approximate 1,300 new patients added to the commercial drug in the fourth quarter. Additionally, we recently received a label update for Chemsaios in Europe to ease the echo monitoring requirements in the maintenance setting for obstructive HEM. 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 U. S. Let's turn to hematology on Slide 14.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

REBIZEL delivered more than 70% growth, reflecting solid uptake across first and second line MDS associated anemia patients. Sales in The U. S. Benefited from demand and included onetime gross to net benefit. Outside The U.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

S, REBIZEL sales more than doubled, driven by demand across newly launched markets in Europe and a strong launch in Japan. In cell therapy, Brianca's fourth quarter sales more than doubled, driven by its best in class profile and strong demand growth across all its proved indications. Now moving to immunology on Slide 15. Global sales of SITC-two grew more than 30%. U.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

S. 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 SORTICT2 specifically, this will temper our reported sales in the first half of the year until demand volume can offset these impacts.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

I will wrap up reviewing our performance for the quarter on Slide 16 with neuroscience and Cobenphi. Cobenphi sales in the fourth quarter were approximately $10,000,000 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 Cobenfe's differentiated efficacy and safety profile. Let's now move to P and L on Slide 17.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

As expected, gross margin declined about two forty basis points in the fourth quarter, driven primarily by product mix. Excluding in process R and D, operating expenses increased approximately 8%, largely driven by R and D investments, partially offset by our ongoing cost savings program. Regarding our operating expenses, we made significant progress during 2024 against our 1,500,000,000 strategic productivity initiative. As of the end of the fourth quarter, we realized approximately $1,100,000,000 in savings and expect the remaining $400,000,000 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 14.9% in the prior year, primarily driven by earnings mix.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

For the full year, excluding in process R and D charges, our effective tax rate was 18%. Overall, diluted earnings per share were

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

$1.67 for the quarter and full year diluted

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

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 $11,200,000,000 in cash equivalents and

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

marketable securities as of December 31. We generated

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

strong cash flow from flow from operations of approximately $4,400,000,000 in the fourth 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 twenty twenty four, we have repaid approximately $6,000,000,000 of the $10,000,000,000 of debt we committed to pay down relative to our 03/31/2024 balance. Our capital allocation priorities also include returning cash to shareholders through our commitment to the dividend.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

2025 marks our ninety third 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 call 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 $2,000,000,000 of incremental run rate operating expense savings with approximately $1,000,000,000 to be achieved in 2025 and the remainder by the end of twenty twenty seven. 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.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

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 $1,500,000,000 cost savings program, where savings were mainly reinvested, this expanded program will see the incremental $2,000,000,000 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.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

As Chris said earlier, we estimate revenue in 2025 to be approximately $45,500,000,000 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 in the legacy portfolio due to the stacking of LOEs and anticipated headwinds from foreign exchange of approximately $500,000,000 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 and L line items, we expect our gross margin to be approximately 72%, which reflects the impact of product mix. Excluding in process R and D, we expect total operating expenses to show a meaningful decline to approximately $16,000,000,000 driven by the expanded cost savings program I just mentioned. We anticipate our overall expenses to be more evenly phased throughout the year.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

Operating margin is expected to be approximately 37% for 2025. We're expecting OI and E income of approximately $30,000,000 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.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

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 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 twenty four months and will de risk our pipeline and provide more certainty on the future shape of our company.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

And with that, certainty on the future shape of our company. And with that, I'll now turn the call back over to Chuck for Q and A.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Thanks, David and Chris for the prepared remarks. Allison, could we please poll for questions?

[Operator]

Sure. And we will now begin the question and answer session. The first question today will come from Chris Schott of JPMorgan. Please go ahead.

[Chris Schott, Managing Director at JP Morgan]

Great. Thanks so much. Just two quick ones for me. First on Cobenphi, 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 the space?

[Chris Schott, Managing Director at JP Morgan]

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 $2,000,000,000 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 if 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Great.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Thanks, Chris. So, in regards to Cobenphi, we're very pleased what we're seeing with Cobenphi 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

I'm also pleased with the number of trialists we're seeing since launch and we have an opportunity to further expand and increase adoption with the 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 team educating customers on Coventi's 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

And as we said, with a ramp in the back half of this year. But taken together, 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks, Adam. And Chris, with respect

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 then maybe just give you two quick vignettes on that. We plan to initiate seven Phase three programs starting this year on CoBinpi clearly illustrating that we'll continue to invest in our pipeline.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 Chemsios, Opdivo and Briandzi. 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 that it makes sense for us to capitalize on those opportunities now.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 year's program. It gives us more financial flexibility.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

That financial flexibility gives us strategic flexibility. 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 business is.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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, Head of Global Pharma Equity Research at Berenberg]

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

[Luisa Hector, Head of Global Pharma Equity Research at Berenberg]

Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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, POMOLIS, DURENCIA and CAMZYOS, for example, that's going to offset the Eliquis favorability as we see increasing growth 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

But as we've said previously, we would project this to be roughly net neutral across our portfolio this year. As it relates to cindacumab, given the data that we have seen, we've made the decision not to commercialize cindacumab. And we are going to continue to prioritize investments and 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 ZAPOSIA in UC as we saw the unsuccessful trial in Crohn's disease and based on our competitive positions with ZAPOSIA and IBD, we made that decision as well.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Thanks, Adam. Next question please, Allison.

[Operator]

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

[Geoff Meacham, Managing Director at Citi]

Good morning, guys. Thanks so much for the question. I had another one on Coventy. I know, Chris, you highlighted the expansion opportunities on Slide six. I guess, are there others that you could add or accelerate beyond what you have?

[Geoff Meacham, Managing Director at Citi]

I guess the main question is since the Imraclidine 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 imminent. What are the potential puts and takes on IRA revisions? Obviously, there's been a lot of chatter on what discounting could look like in the outer years. Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 COPINVIA. Obviously, the competitive dynamics and changes on the competitive front have an impact at the short term on that product. We have always been focused on delivering that product as quickly as possible to patients.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 Sam and Adam want to comment.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Yes, absolutely true what Chris just said because if you think about the dual muscarinic 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

I'll just add, Sumit. Our focus has been on ensuring a successful launch where generics, atypicals have about 80% market share and Cobenpi has significant safety and efficacy advantage there. 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 mechanism of action. So we didn't expect competition from other muscarinic in schizophrenia until late twenty six or early twenty seven and the failure of imraclidine, we have a clear path forward in schizophrenia and we're excited about the opportunity with COPENFE. And we believe that we're going to drive meaningful growth for COPENFE really into the middle of the next decade.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

concerns that we have with that law and we see the

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

need to have a have a number of fixes that will avoid some of the more damaging aspects of the law and some of the more perverse 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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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

[Operator]

And the next question will come from Kurt Shibutani of Goldman Sachs. Please go ahead.

[Chris Shibutani, Analyst at Goldman Sachs]

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?

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Maybe I'll start and then turn it over to Samit. I think Chris, you've correctly pointed out there 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 and 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 catalyst that are coming forward over the next twenty four months is that we have been focused on ensuring we hit the timelines that we set internally and where possible accelerate.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

And Simon Steen has done a nice job of helping us do that. So Simon, do you want to comment on specifics?

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Yes, 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 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.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

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 to the patients and to commercialization. All of that has helped. And the examples are right in front of you.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Last year, we were able to accelerate and deliver the psoriatic arthritis data early. This year, we'll be able to give KANZYOS 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 SOTYK2. And of course, that mindset will go in all of these seven trials that we've talked about for Cobenvy as well.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

And

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

just to put a finer point on what Sam had 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 on time is we think critical and we've made good progress in 2024. And as Amit said, we're heads down continuing to execute on that.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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, Managing Director, Senior Equity Research Analyst at Bank of America]

Thank you very much. I have a couple of questions. So the revenue guidance for '25 is about $1,000,000,000 less than consensus. In as much as you've looked at consensus, where are you seeing the biggest differences? Could Coventry be one of those contributors of the delta?

[Tim Anderson, Managing Director, Senior Equity Research Analyst at Bank of America]

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 has felt like maybe 2028, '20 '20 '9. Is that still the right way to think about it? And could a product like Coventry or some of these other programs possibly pull that forward?

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 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 POMOLAZE, which lost exclusivity in Europe as well as in The U. S.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Price on Abraxane 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, EVP & CFO at Bristol-Myers Squibb Company]

Yes. Tim, thank you for the question. And just as a reminder, Bloomberg's for the total company sitting around 46.2%, we're guiding approximately 45.5. If you remember in my prepared remarks, so there's a headwind of currency, which we don't believe has been built in, which is around $500,000,000 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 highlighting is around the legacy portfolio in particular, Resilmate coming down to two, two point five as well as the other generic impacts that we mentioned on the call.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

But overall, we feel pretty good where we are versus consensus.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 Covinfe 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 debt gain. So we're going to continue to be focused on finding ways to use capital to continue to accelerate the growth profile.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

be

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

transparent about our performance against on these calls.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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

[Operator]

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

[Mohit Bansal, Analyst at Wells Fargo]

Great. Thank you very much for taking my question. My question is regarding Aliquest. So I mean, so there was some thoughts about Aliquest getting some tailwind because of RDA design given that there's no doughnut hole now and maybe there is like given the price point, the impact of RDA 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?

[Mohit Bansal, Analyst at Wells Fargo]

Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Yes, Mohit, thanks for the question. As I mentioned, we're going to see favorability with Eliquis this year in The U. S. Due to 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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 when we look at where we are positioned in the market in The U. S, we have a market share that continues to grow linearly. Our share in The U.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

S, NBRx is roughly 75%. And we know that with Xarelto out of the market, we've got a great opportunity to continue to drive this important brand for the company.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Great. Thanks, Adam. Next question, please.

[Operator]

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

[Trung Huynh, Executive Director - Equity Research 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?

[Trung Huynh, Executive Director - Equity Research at UBS Group]

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 Quantic and any thoughts on the uptake for '25? Thanks.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks for the questions, Trung. David, you will take the first one and then Adam will be coming on the second.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

No, as you said, the step down will be mainly driven by REVLIMED and POMELUS, volumes coming through with those gross margins being slightly 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 would 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Yes. So as it relates to OpdivoCuvantec, these are very early days. The teams out in the field educating healthcare practitioners on the benefits of 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 twenty twenty eight, which will extend the

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

franchise into the 2030s.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

We have seen so far, some very positive feedback early on as 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 Opdivo QVANTIG 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 sub two 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 the category.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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' positions and importantly the durability of our IO franchise.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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

[Operator]

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

[Evan Seigerman, MD & Senior Research Analyst at BMO Capital Markets]

Hi, guys. Thank you so much for taking my question. One on BD, more Now that we're on this side of the Muscarinic debate with Coventry approved and Emiraquidy not showing in efficacy, can you walk us through kind of your process in determining why you went for KORUNA when you wanted to get into schizophrenia? And on kind of a more mechanistic perspective, what's happening with Kemzaris? We saw a nice step up.

[Evan Seigerman, MD & Senior Research Analyst at BMO Capital Markets]

What are you seeing in the field that's driving the uptake there? Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

It started with, making sure that we really liked 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

You actually saw how we executed against that post the decision to acquire, in that we spent a lot of time with the Heritage Corona 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 VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Yes. Evan, regarding Kymsios, we've seen strong steady and consistent growth from Kymsios. 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

And as you're also aware, we have a data readout in non obstructive HCM and we're Odysee data in Q2 and that will expand the eligible patient population by about thirty percent 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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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, Managing Director at Jefferies]

Hey, thanks so much. So what's the risk around the adjunct schizophrenia trial for KABENFE? 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 fiftyfifty coin flip? And on the Cymbiosis label update, are you aiming for six months ECHO monitoring requirements?

[Akash Tewari, Managing Director at Jefferies]

And if so, how do you think that will help expand access into the community setting? Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks for the question, Samit and Adam.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Sure. Thank you for the question. On the adjunctive schizophrenia, remember where we started off and how patients are treated in the real world. So we obviously have developed the drug as a monotherapy. These patients were primarily before they got onto the trial, were receiving the D2 agonists.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

And thereafter, there was a washout period, patients came on the drug and then of course the trial evaluated the primary endpoint in emergent one, two and three at the shorter window. But But remember, emergent four and five have now read out with a fifty two 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

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

fifty two week data point as well.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

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 Kymbzios, 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.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

And from that perspective, it was important the data that we've collected from the real world as well as from the clinical trial suggests that the overall safety profile of Chemsios is maintained. Many of the patients are treated actually at the lowest dose of two point five and five 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 the longer duration in between echoes as we look to The U. S. Reviews as well.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Adam, if you want to add anything?

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Just adding just one bit. You know, 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 twelve weeks to once every six months when patients are in the maintenance phase, so that's after week twelve. And what we would expect is not so much in the community, but this will open up additional capacity at centers of excellence and as a result, physicians will be able to treat more patients.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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, Equity Research 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 twenty seven as being $15,000,000,000 so an incremental $1,000,000,000 off of the $16,000,000,000 now?

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

Just wanted to make sure I understood it correctly. And then on Iberdomide, 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?

[Terence Flynn, Equity Research Analyst at Morgan Stanley]

Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks, Terrence. David and Samit.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

Yes. Thanks for the question. Yes, you have that right. So we said an incremental to $2,000,000,000 program, all that dropping to the bottom line. Instead of $1,000,000,000 of that would drop this year with operating expenses of $16,000,000,000 The further $1,000,000,000 achieved by 2027 would get you to operating expenses of $15,000,000,000

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

In terms of thinking about Iberdomide, 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'll observe at the end of 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.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Remember, we have not taken out 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 as framing all of this discussion around cost.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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

[Operator]

The next question will come from Courtney Breen of Bernstein. Please go ahead.

[Courtney Breen, Senior Research Analyst at Bernstein]

Thanks so much for taking my call today my question today in the call. Two parts, I think you spoke a little bit about business development in an 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 Codenthe 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 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?

[Courtney Breen, Senior Research Analyst at Bernstein]

Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Great. Thank you, Chris. I'm sorry

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

to leave.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

And Alex answered the question around that. Courtney, thanks for the question. As it relates to gross to net, the brand is going to continue to lean heavily towards the public sector of Medicare and Medicaid. And you think about the evolution of schizophrenia and schizophrenia indications or our Alzheimer's indications, whether it be Alzheimer's, the psychosis or Alzheimer's cognition, these are patients who are going to be in Medicare or Medicaid.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Commercial patients are less than ten percent. 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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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, Senior Managing Director at Guggenheim Partners]

Great. Thanks for the question. So just quickly on Covancey, 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 BID 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?

[Seamus Fernandez, Senior Managing Director at Guggenheim Partners]

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 ibrutamide or mesiktumide could appropriately fit within the context of the overall multiple myeloma market given the availability of generic Revlimid and POMOLIS? Thanks.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks, Seamus. Adam and then maybe Samu can chime in as well.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Yes, 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 fifty 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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 fifty milligrams, they're taking a week or two before they titrate up to the next dose at one hundred, unlike what you saw in the clinical trials, which moved to one hundred and twenty five 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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 Coventy with food that will read out this year. So it will also improve the ease of prescribing for physicians and make it easier for patients as well.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

So I'll just take it out from there. And one thing that I would just add on Cybenphi. So prior to Cybenphi, what drugs were doing was treating the symptoms of schizophrenia, meaning the positive symptoms by Meredith. With Cybenphi, now we are treating schizophrenia, meaning also impacting the negative symptoms and we are seeing the impact on cognition as we have recently published data. On multiple myeloma switching gears, it's important to understand where the patients are treated and what the drugs are available.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

If you think about the cell therapies and the T cell engagers or bispecifics, they are to be primarily used in the academic settings, whereas most of the patients with multiple myeloma, especially with the relapsedrefractory 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 programs 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 Iberdomide, mesiktomide sit. You know mesiktomide is being compared head to head versus thromalidomide and that's how you replace thromalidomide and then of course there's another trial looking head to head iberdomide versus REVLIMID which certainly will read out later, but it is a very important component of the overall development plan.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Great. Thanks Amit. Next question please, Allison.

[Operator]

Our next question will come from David Risinger of Leerink Partners. Please go ahead.

[David Risinger, Senior Managing Director & Senior Research 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 the box to speak.

[David Risinger, Senior Managing Director & Senior Research Analyst at Leerink Partners]

So I have two questions. First, with respect to the performance in 'twenty five, so obviously the worse that the LOEs perform in 'twenty five, the better the setup for the trajectory of growth for the company in 'twenty six. But if the loss of exclusivity products performed better than expected, then it makes it a little bit tougher to grow in 'twenty six. Could you just discuss that a little bit and provide some initial context for 2026? I know that you're not providing guidance at this time.

[David Risinger, Senior Managing Director & Senior Research Analyst at Leerink Partners]

And then second, just with respect to Yervoy, it's been performing very strongly, growing 20% roughly in the fourth quarter and roughly 20% for full year 2025 sorry, 2024. Can you comment on growth prospects for Yervoy going forward as well? Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks, David. David, Elkins and Adam.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

Yes. So just on your question around 25% and what to think about heading into 26%. First, Revlimated, 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 twenty twenty six. So we'll be through that by the end of the year.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

And we have generic entry of POMOLIS 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 'twenty six and 'twenty seven. 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.

[David Elkins, EVP & CFO at Bristol-Myers Squibb Company]

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 KEMZYOS and TIK2 as well as Revlisel. And we got some really important data readouts that we're going to be able to add up to six new NMEs 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 COPENSI 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 VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

As it relates to Yervoy, we're seeing solid demand growth across our core indications, first line long, first line RTC, as well as first line melanoma, where Yervoy is using combination. And that growth is coming both from The U. S. And from our international markets. In The U.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

S, we continue to see good adoption in the community. And as you know, last year we presented, I think, is remarkable ten 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 Yervoy, which will help drive Yervoy performance. We also have the OPDIMO Yervoy lung approval that's pending in China. So taken together, we would expect continued growth from Yervoy in 2025.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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

[Operator]

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

[Matthew Phipps, Group Head - Biotechnology at William Blair]

Thanks for taking my questions. Following up on the MRD primary endpoint for the ebertamide trial, is there a time course that the FDA wants as far as how much durability on that MRD? And why not add MRD endpoints to the mesigdemide trials? It does look like you already have MRD on the Arlocell Quintessential two. And then similarly in multiple myeloma, is there a point at which a BECMA what is kind of the profitability breakpoint for a BECMA?

[Matthew Phipps, Group Head - Biotechnology at William Blair]

And does success of Arlocell really kind of negate the need for Abekma? Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks, Matt. And Samit and Adam.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

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 iverdomide trial.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

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 X-ray or 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 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 VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Yes. As it relates to ABECMA, 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 Beqma and we're going to remain competitive in the 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

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

improved safety profile.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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

[Operator]

The next question will come from Stephen Scala of TD Cowen. Please go ahead.

[Steve Scala, Pharmaceutical Analyst at TD Cowen]

Thank you so much.

[Steve Scala, Pharmaceutical Analyst at TD Cowen]

I have two questions. First, Bristol's second generation TIC2 completed Phase two in psoriasis in August of twenty twenty four, but hasn't progressed. So curious what the profile of this agent is? What are plans and is IBD within those plans? And secondly, Milvexion Phase three readouts in stroke and ACS are expected in 2026, but later in the year.

[Steve Scala, Pharmaceutical Analyst at TD Cowen]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks, Steve. Samit.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Thanks, Steve, for both the questions. So first of all, for the backup TIK2, we completed those studies. We have the data. But as you know, we are continuing to progress our overall plans for SOTIC2 at this time. And as we spoke earlier, we have to decide within our pipeline where we are going to really focus and prioritize.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

And at the current time, our focus is truly squarely on Sotek two and maximizing that opportunity from a development commercial perspective. So at this time, that TIK two 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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Great. Thank you, Shailesh. Next question please.

[Operator]

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

[Kripa Devarakonda, Vice President - Equity Research at Truist Securities]

Hey guys, thank you so much for taking my question. I have a candidized question. Congrats on getting the label update in EU. I was wondering with the label change in EU and potentially a change in The U. S.

[Kripa Devarakonda, Vice President - Equity Research at Truist Securities]

As well, how do you see the peak opportunity now? And with Odysee data upcoming this year, can you help set expectations for the readout? And then if I can squeeze one in for Coventry. One of the KOs 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?

[Kripa Devarakonda, Vice President - Equity Research at Truist Securities]

Thank you.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Yes. So I can certainly take those, Kippa. 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 as a 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.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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 Odysee readout, maybe Sumit, 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 positive around a third of patients in HCM and have an opportunity to build upon the success of Kamsitos 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 Sumit to talk a little bit more about MHCM and then I'll quickly answer your Gobenphi question at the pharmacy.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Yes, I'll address the Odyssey question very quickly. The paper from methodology perspective as well as the baseline characteristics of the were just published in JACC heart failure. So you can certainly pick it up from there and the primary endpoints of KCCQ and PVO2 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 will be able to see the results and then we

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

will share that with you.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

Yes. Just really quickly on that. We are not hearing that. Our teams are out both with physicians, but they are also at the pharmacies as well. So, I do think that is potentially a one off and we want to make sure that the Coventry is available broadly across The U.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

S. So patients can get access to this really important product.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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 KENSIOS REMS? 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 December agenda?

[Olivia Brayer, Analyst at Cantor Fitzgerald]

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 twelve weeks to once every six months. Just wanted to clarify that I heard that correctly.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Thanks. Samit and Adam.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

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 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.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

So overall data package was very strong and we continue to have the dialogue with the regulatory agencies.

[Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company]

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

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Thank you, Adam. Next question please.

[Operator]

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

[James Shin, Director of Biopharma Equity Research at Deutsche Bank]

Thank you for the question guys. I just wanted to follow-up on the RISE question. What are BMY's expectations for the PAN Score benefit? And then any color on how ADAPT2 will be disclosed? Will the NPIC be top line in the PR?

[James Shin, Director of Biopharma Equity Research at Deutsche Bank]

And will this be followed by a full data set at that Medical Congress? Thank you.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Amit?

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

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, if it benefits out, we will be putting out a press release. But generally, we do not disclose the data.

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

Those will be presented at 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 and as well as we look the difference that we observe 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're 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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Great.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

Thanks, Usama. Next question please.

[Operator]

Hi, guys. Thanks for the question.

[Sean McCutcheon, Vice President - Biotechnology Equity Research at Raymond James Financial]

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

[Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company]

RAISE portfolio perspective, of course, Phase III is already ongoing in GAPNET and this is in the patient population that has already received prior Lutathera. So it's and certainly the Phase one 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 one study and we recently started a breast cancer program as well. And from the portfolio perspective, we have we're looking forward to initiation of our Phase one program for GPC3 III as a new target and then of course there's a pipeline behind it in the research space as well.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

And the only thing I would add is that we continue to be looking for opportunities to enhance the acquisition of RAISE. 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.

[Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company]

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.

[Alexandria Hammond, Director, Head of Therapeutics at Wolfe Research LLC]

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

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Yes. 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 Covinfe.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

Clearly, we also are very excited about our cell mod programs. We have multiple cell mods that we've spoken about today, Iber and mezi, but we haven't spoken about glottamide. That's a potentially very meaningful product in lymphoma. Lylexion 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

And we haven't even talked about the next wave of assets, which include some really exciting opportunities, including products like CD19, NextE, 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 twenty four 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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

I know we went a

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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.

[Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company]

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 right size our cost structure and invest in future growth. 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 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

Analysts

• Charles Triano, SVP & Head of Investor Relations at Bristol-Myers Squibb Company
• Christopher Boerner, CEO & Chairman at Bristol-Myers Squibb Company
• David Elkins, EVP & CFO at Bristol-Myers Squibb Company
• Chris Schott, Managing Director at JP Morgan
• Adam Lenkowsky, Executive VP, Chief Commercialization Officer & Head of U.S. Oncology at Bristol-Myers Squibb Company
• Luisa Hector, Head of Global Pharma Equity Research at Berenberg
• Geoff Meacham, Managing Director at Citi
• Samit Hirawat, Executive VP & Chief Medical Officer of Drug Development at Bristol-Myers Squibb Company
• Chris Shibutani, Analyst at Goldman Sachs
• Tim Anderson, Managing Director, Senior Equity Research Analyst at Bank of America
• Mohit Bansal, Analyst at Wells Fargo
• Trung Huynh, Executive Director - Equity Research at UBS Group
• Evan Seigerman, MD & Senior Research Analyst at BMO Capital Markets
• Akash Tewari, Managing Director at Jefferies
• Terence Flynn, Equity Research Analyst at Morgan Stanley
• Courtney Breen, Senior Research Analyst at Bernstein
• Seamus Fernandez, Senior Managing Director at Guggenheim Partners
• David Risinger, Senior Managing Director & Senior Research Analyst at Leerink Partners
• Matthew Phipps, Group Head - Biotechnology at William Blair
• Steve Scala, Pharmaceutical Analyst at TD Cowen
• Kripa Devarakonda, Vice President - Equity Research at Truist Securities
• Olivia Brayer, Analyst at Cantor Fitzgerald
• James Shin, Director of Biopharma Equity Research at Deutsche Bank
• Sean McCutcheon, Vice President - Biotechnology Equity Research at Raymond James Financial
• Alexandria Hammond, Director, Head of Therapeutics at Wolfe Research LLC