Bristol-Myers Squibb Co
NYSE:BMY
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Bristol-Myers Squibb Co
Earnings Call Analysis
Q1-2024 Analysis
Bristol-Myers Squibb Co
The first quarter of 2024 was a busy and productive period for the company, marking a solid beginning for the year. The performance of the commercial portfolio was strong and aligned with expectations, despite some headwinds from inventory adjustments and gross-to-net impacts. Key brands such as Eliquis, Opdualag, Reblozyl, Yervoy, and Breyanzi showed robust performance, contributing significantly to the company's revenue.
The company made notable progress in advancing its pipeline, which includes important approvals and the initiation of new trials. Two critical cell therapy approvals were achieved, and a new Phase III registrational trial for Opdualag in non-small cell lung cancer is set to begin. Additionally, the potential of milvexian, an oral Factor XIa inhibitor, is being explored in ongoing trials for atrial fibrillation (AFib) and acute coronary syndrome (ACS).
During the quarter, the company completed four significant acquisitions, enhancing its long-term growth prospects. The integration of assets from these acquisitions, such as RayzeBio, is expected to strengthen the portfolio and provide a diversified growth engine. Key products from these acquisitions, including KarXT from Karuna and a first-in-class bispecific ADC from SystImmune, are positioned to enhance the company's market presence.
The company reaffirmed its guidance, expecting low single-digit revenue growth for 2024 at both reported and constant currency rates. The gross margin is anticipated to be approximately 74%, with total operating expenses forecasted to increase in the low single-digit range. The company's non-GAAP EPS guidance remains between $7.10 and $7.40. The company aims to maintain an operating margin of at least 37% through the next year, and expects $250 million in other expenses primarily due to interest costs from recent debt financing.
A new productivity initiative aims to save approximately $1.5 billion by the end of 2025. These savings will be achieved through measures such as clinical expense reductions, site rationalization, and headcount reductions. The savings will offset incremental operating expense increases from recent acquisitions and support reinvestment into higher ROI opportunities, thereby improving the company's long-term growth profile.
The company generated approximately $2.8 billion in cash flow from operations in the first quarter, resulting in around $10 billion in cash and marketable debt securities by March 31. The strategic approach to capital allocation remains firm, with a commitment to dividends and a plan to repay around $10 billion of debt over the next two years. This disciplined financial strategy aims to ensure long-term growth and financial stability.
Strong growth was reported for several key brands. For example, Abecma returned to growth following the KarMMa-3 approval, while Camzyos continued to show positive momentum with real-world evidence supporting its efficacy. The company's focus on expanding patient access and market share across its portfolio is poised to drive sustained growth.
The company is poised for ongoing growth and development. The promising contributions from new acquisitions, strategic cost savings, and expanding market share for key products all contribute to a strong future outlook. Efforts remain focused on driving both short-term performance and long-term expansion, ensuring continued success and value creation for shareholders.
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Welcome to the Bristol-Myers Squibb First Quarter 2024 Earnings Conference Call. [Operator Instructions] Please note, today's event is being recorded.
I would now like to turn the conference over to Tim Power, Vice President and Head of Investor Relations. Please go ahead.
Thank you, and good morning, everyone. Thanks for joining us this morning for our first quarter 2024 earnings call. Joining me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer; and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Lenkowsky, our Chief Commercialization Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to bms.com that you can use to follow along with for Chris and David's remarks.
Before we get started, I'll read our forward-looking statement. During this call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these 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. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com.
And with that, I'll hand it over to Chris.
Thank you, Tim, and good morning, everyone. Q1 was a busy quarter for us and a good start to 2024. Starting on Slide 4, and knowing what an active quarter we had, I wanted to start by telling you how we think about our performance across four dimensions.
First, the performance of our commercial portfolio was good and broadly in line with our expectations, even with some products impacted by inventory or gross to nets. Second, we made solid progress advancing our pipeline. Third, we closed four import transactions that strengthened our long-term growth profile during Q1. And fourth, we're taking decisive actions to improve productivity.
Taken together, Q1 performance was broadly aligned to our internal expectations. And importantly, there is no change to the underlying business outlook we provided in February. As you know, we've included the accounting impact of the recently closed transactions in our non-GAAP EPS guidance.
Let's turn to Slide 5 for some details. I'll start with some highlights on commercial performance. We've seen real strength across key brands, including Eliquis, Opdualag, Reblozyl, Yervoy and Breyanzi. And though the BCMA space remains competitive, our objective is to return Abecma to growth over time with the KarMMa-3 approval as we move into a larger patient population.
Turning to Opdivo, Camzyos and SOTYKTU. What's important about all three brands is that demand grew while revenue was impacted by other factors such as inventory and gross to nets. Today, we are seeing the inventory patterns for Opdivo and Camzyos normalizing. And for SOTYKTU, we're steadily building commercial script volume as access continues to improve this year. David will give you more details, but taken together, the commercial performance in Q1 is in line with our expectation and sets us up for the year.
Second, we made important progress advancing our pipeline. This includes two important cell therapy approvals, the initiation of new registration trials and important proof-of-concept data for Opdualag in lung cancer from a prespecified analysis of our Phase II during Q1. We're looking forward to starting a Phase III registrational trial versus standard of care in a segment consisting of about 20% to 30% of non-small cell lung cancer patients.
And not on this slide, but important for patients is milvexian, which has the potential to be the only oral Factor XIa medicine in AFib and ACS. The trials are continuing following the most recent DSMB review with enrollment accelerating.
Third, we closed four important deals during the quarter. Across all four, we have added assets, capabilities and expertise that strengthen our ability to drive long-term growth as we exit the 2020s. Our team is driving performance of Krazati, the Rayze radioligand plant in Indiana is now operational. We're in the process of filing an application to supply clinical product for RYZ101 from the site. SystImmune's first-in-class bispecific ADC is advancing into global clinical trials in tumors, including lung and over time, breast cancer. And we are very excited about the potential of KarXT from Karuna, which I will review on Slide 6.
The team is on track and focused on two objectives: First, launch preparations are underway and on track for KarXT; second, we are executing against a robust clinical program for this important asset. On this slide, you can see the significant unmet need in schizophrenia and highlights of data recently presented for KarXT. These data demonstrate its compelling long-term efficacy as KarXT was associated with significant improvements in symptoms of schizophrenia across all efficacy measures without evidence of metabolic or movement disorder side effects.
This reinforces the very attractive profile for this medicine as an important advancement for patients and a significant commercial opportunity for the company. Underpinning our efforts to navigate this decade is an enhanced focus on driving operational productivity and efficiency, and we have made some notable progress already this year.
Let's go to Slide 7. At a company level, we have clearly identified brands and programs that are most critical to both near and latter half of the decade performance. Across the organization, we have initiated efforts to delayer and streamline decision-making. And within R&D, we are optimizing the portfolio to focus our internal efforts on higher ROI programs. These are programs with compelling science, significant commercial value and in therapeutic categories where BMS is positioned and resourced to win. As a result of these actions, we anticipate cost savings of approximately $1.5 billion by the end of 2025, which will allow us to reinvest in high priority growth brands and R&D programs.
With our heightened focus on improving productivity and efficiencies, we're strengthening the company's long-term growth profile. This is a snapshot of what has been a very busy start to the year. And while we clearly have more work to do this year, we're off to a good start.
Let me close on Slide 8. Overall, our business outlook remains unchanged. We remain confident that we will deliver top line growth for the year consistent with what we communicated in February. And our underlying non-GAAP EPS forecast has also remained unchanged.
We are taking important actions to effectively manage the decade. Our management team is focused on ensuring the disciplined execution required to deliver both this year and set us up for the longer term. I want to thank the employees of BMS, including new team members from our recent acquisitions for their contributions and commitment to delivering for patients.
Let me now hand it over to David. David?
Thank you, Chris, and good morning, everyone. As Chris highlighted, we're off to a good start to the year with top line growth as shown on Slide 10. As a reminder, 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.
Building our momentum coming out of last year, we're executing against our plan to drive our growth portfolio, which delivered approximately 11% sales increase in the first quarter compared to the prior year and now represents approximately 40% of our total revenue. This growth was broad-based, with most growth brands recording significant increases in the quarter. Our legacy portfolio also contributed to overall sales growth in the quarter, with strong sales of Eliquis, which remains an important cash flow generator for the company.
Now turning to the first quarter performance of our key brands, and starting with oncology on Slide 11. On this slide, you can see the impact of our strategy and broadening our I-O franchise and expanding in new targeted solid tumor therapies. Global sales of Opdivo were impacted by inventory work down and timing of orders in the U.S., partially offset by demand growth. As we said in the past, we expect to see growth at a more modest pace than 2024.
And Opdualag, a standard of care treatment in first-line melanoma, generated strong quarterly sales with U.S. sales growth primarily driven by strong market share. We are very encouraged by the future expansion potential of Opdualag, not only in adjuvant melanoma, but also in our plans to develop it in first-line lung cancer. This, along with the anticipated launch of our Opdivo subcutaneous formulation next year, we will extend our I-O franchise well into the next date. Our targeted solid tumor therapies expanded with the addition of Krazati after the completion of Mirati acquisition in late January.
Our reported sales represent a partial quarter. And on a pro forma basis, Krazati global sales in Q1 were approximately $27 million, primarily in the U.S. With recent conditional marketing approval by the European Commission, we look forward to bringing Krazati to more patients towards the end of the year. Augtyro's first quarter performance reflects positive early sales trends. We remain focused on driving awareness and penetration based upon its potential best-in-class profile.
Now moving to Slide 12 and our cardiovascular franchise. Eliquis remains the market-leading oral anticoagulant worldwide. Q1 sales in the U.S. grew 12%, primarily due to strong demand, including increased market share. Internationally, sales were roughly in line with prior year. Camzyos generated strong sales in the quarter, nearly tripling its performance versus Q1 of last year.
In the U.S., sales were driven by demand growth including an almost 25% increase in commercial dispenses since Q4 of 2023. Sequentially, U.S. sales of Camzyos were impacted by the inventory dynamics of approximately $20 million and gross to net impacts from the typical copay reset at the start of the new year. We expect the momentum of Camzyos to continue, supported by the compelling real-world evidence in over 1,500 patients presented earlier this month at ACC.
Let's now turn to Slide 13 and discuss our hematology business. Our legacy brand, Revlimid, saw sales decline in the first quarter. Utilization of free drug program normalized in the quarter. We continue to anticipate variability in Revlimid sales quarter-to-quarter based upon historic dispensing patterns in specialty pharmacies. As anticipated, there is an increased volumes of U.S. generics starting in March.
Turning to Reblozyl, growth in the quarter was driven primarily by the strong U.S. launch of the broader commands label and first-line MDS. International sales growth benefited from the new market launches, and we look forward to bringing Reblozyl to more patients with the recent first-line approvals in the EU and Japan.
In cell therapy portfolio, global Breyanzi sales growth reflected the strength of the clinical profile and improved manufacturing capacity. Consistent with what we previously communicated, starting in Q2, we expect Breyanzi to benefit from the recent new indications and expanded manufacturing capacity.
With Abecma, U.S. performance in the quarter was impacted by ongoing competitive pressures. Future demand will benefit from the recent KarMMa-3 approval, which expands the addressable patient population. Internationally, Abecma demand growth was offset by unfavorable pricing pressures to secure access.
Now moving to immunology on Slide 14. Zeposia sales in the quarter were primarily due to demand of new patient starts in multiple sclerosis. SOTYKTU sales performed in line with our expectation. During the quarter, we delivered on our goal of achieving roughly 10,000 commercially paid prescriptions. Sales in the quarter reflected increased demand and expanded commercial access. In addition, we expect to add another large PBM later this year that will expand access coverage by approximately 30 million lives.
Now turning to Slide 15. I will walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. As expected, gross margin decreased compared to the prior year, primarily due to product mix. Excluding acquired in-process R&D, first quarter operating expenses increased mainly due to the impact of the recent acquisitions and higher cost to support the overall portfolio. We expect this growth to be mitigated later in the year through savings and productivity initiatives I will speak to shortly.
Other income and expense declined as expected in the first quarter, primarily due to lower PD-1 royalty rate and the financing costs associated with the recent transactions. Acquired in-process R&D in the quarter was $12.9 billion, primarily due to the previously disclosed onetime charge of $12.1 billion for the Karuna transaction and $800 million for SystImmune. Our tax rate in the quarter was impacted by the onetime nondeductible in-process R&D charge for Karuna.
Before the impact of acquired in-process R&D, our first quarter earnings would have been $1.89. Taking into account the impact from the recent transactions, including acquired in-process R&D, we reported an earnings per share loss of $4.40.
Now moving to the balance sheet and capital allocation on Slide 16. Cash flow from operations remained strong with approximately $2.8 billion generated in the quarter, resulting in approximately $10 billion in cash and cash equivalents and marketable debt securities on hand as of March 31.
Our strategic approach to capital allocation remains unchanged. We are committed to the dividend. And as we said previously, we plan to utilize our cash flow to repay approximately $10 billion of debt over the next 2 years. And we remain financially disciplined around business development to further strengthen the company's long-term growth profile.
Next, let's turn to Slide 17 to discuss our productivity initiative. As Chris described earlier, we have taken action to increase productivity and efficiency and focus our efforts on the assets and opportunities with the highest potential ROI and those most likely to drive our long-term growth. As part of this process, we are making deliberate choices to prioritize the assets that will have the greatest clinical benefit to impact areas of high unmet need and where we can deliver the most value for patients.
We will disproportionately invest in higher-return opportunities, which improves our portfolio ROI and strengthens our growth profile in the second half of the decade. After a thoughtful process, we have made the decision to discontinue and externalize several clinical assets. We anticipate cost savings from these actions of approximately $1.5 billion by the end of 2025, thereby absorbing the incremental OpEx expense from the recent deals. These cost savings will come from across the organization and include reductions in direct clinical expense, site rationalization and elimination of open roles and reduction in headcount. As we realize these savings, we will reinvest in the highest potential opportunities.
Now turning to Slide 18. I'll walk through the impact of our recently closed acquisition on our EPS guidance. As you can see on this slide, if you take our previously stated non-GAAP EPS guidance range of $7.10 to $7.40 from February and include the previously stated impact of deal dilution and the onetime impact of acquired in-process R&D, our revised range continues to reflect the strong outlook of the business as we told you in February.
Now let's walk through the details of our guidance on Slide 19, starting with revenue. As is our practice, we provide revenue guidance on a reported basis as well as on an underlying basis, which assumes currency remains consistent with prior year. We continue to expect 2024 total revenues to increase in the low single-digit range at reported rates as well as excluding foreign exchange. This reflects our confidence in the growing momentum of our growth portfolio, including products such as Opdivo, Reblozyl, Breyanzi, Camzyos and SOTYKTU. And as a reminder, the sotatercept royalty will be included in the other growth revenue line.
We continue to expect gross margin to be approximately 74%. And as we saw last year, we should see a sequential dip in Q2 related to our sales mix. Excluding acquired in-process R&D, we continue to expect our total operating expenses to increase in the low single-digit range, reflecting incremental costs associated with the recent acquisitions, partially offset by the realization of internal savings through the productivity initiatives I mentioned earlier.
Given the timing of the deal closures, we expect to come in at the upper end of our guidance range with an expected step-up in Q2 and the remaining OpEx to be more evenly spread across the back half of the year. We remain aligned with our previous operating margin to target at least 37% through next year.
For OI&E, we now expect approximately $250 million of expense primarily reflecting the debt financing costs from Karuna and RayzeBio. The tax rate was affected by onetime nondeductible expense of the Karuna acquired and processed R&D charge, which impacted our non-GAAP net income. Excluding this impact, the estimated underlying tax rate in the quarter was about 19.5%. And as a result, we now see full year underlying tax rate of about 18%.
Before we move to Q&A, let me take a minute to read some of the key highlights on our call today. We grew the top line, we advanced the pipeline, and we are executing our productivity initiative and our expectations for the underlying strength of the business remains unchanged from the beginning of the year. Finally, I'd like to recognize our BMS employees around the world for their unwavering hard work and commitment as we continue to make progress in strengthening the company's long-term growth profile and bringing truly transformational medicines to patients.
With that, I'll now turn the call over to Tim for Q&A.
Thanks, David. Can we go to the first question, please?
[Operator Instructions] Our first question comes from Geoff Meacham with Bank of America.
Just had one for Chris or maybe for David. On the cost savings, how much would you say was legacy Bristol, either workforce or facilities versus optimizing integration of all your recent deals? I guess I'm trying to get a sense for whether you think there's further optimization to come as you guys focus on the new launch portfolio.
Jeff, I'll let David answer that.
Yes. Thanks, Jeff, for the question. The majority of the savings come from the historical BMS. As we talked about, the main drivers of the $1.5 billion savings really came into three buckets. First was really looking at the portfolio, obviously, with the Mirati, Karuna and with RayzeBio, we have really important portfolios that we're bringing into the overall portfolio. That gave us the opportunity to look at that and maximize the ROI of -- in totality of the portfolio as well as adjusting for some updates on new data and the competitiveness.
The second thing that we really looked at for legacy BMS is how do we become more agile, quicker decision-making and streamline the organization by removing layers of management so decisions can be more quickly. And there, we talked about the roughly 2,200 impacted employees as a result of those changes.
And then lastly, we went through all of our third-party relationships, continuing to look for efficiencies in third-party service providers, and that was the last category. And a lot of those activities are also legacy BMS. So the vast majority of the savings are coming from our in-house existing operations.
Our next question comes from Chris Shibutani with Goldman Sachs.
Obviously, a lot of moving parts operationally, strategically. I think investors have been keen to get a sense for how you're thinking about potentially a trough level of earnings. I think the notion that there might be some visibility into where you could begin to see some growth, and I know in your vocabulary, you mused about exiting the decade and into the next. Help us with where you are with that thinking since we haven't had that clarity with all the moving parts. But how are you thinking about the potential to communicate that kind of timeline and model?
Okay. Chris, I'll take that one. And I think there, embedded in that question, maybe two things. First is how we're thinking about how we're going to guide around this trough and then there's maybe a second question in there, which is when we think we'll see that trough and what's the timing of it.
With respect to the first question, look, we've been engaging with investors on this topic over the last number of months. A bit of context here, given the industry dynamics, we -- certainly, I believe companies in this industry need to be judicious with respect to providing long-term guidance. But we get why you are asking the question here, because it's something that we're going to need to continue to engage with investors on to strike the right balance in terms of how we think about providing guidance on this topic.
One uncertainty that we know that's related to this question, though, is the impact of IRA on Eliquis. And once that price is public, and remember, that's going to happen in the September time frame, we'll provide the impact of Eliquis both on the top line as well as on EPS.
In terms of how we think about the timing of the trough, based on our current plans, we start to see an impact in 2026. And then as we said earlier in the year, we anticipate to be returning to growth before the end of the decade. And then obviously, we're clearly focused on accelerating both the timing and the pace of growth in the back half of the decade, and that's going to influence timing as well.
Our next question comes from Chris Schott with JPMorgan.
Just a two-parter, coming back to the restructuring. I guess the first part is, is the redeployment of savings going to be mostly focused on the R&D side or on SG&A? And just related to that, in terms of investment in the growth drivers, it seems like elements such as payer dynamics and competitive launches are impacting uptake of some of the new launch assets. So I'm just interested in which products do you see having the greatest potential for improvement with further investment, and how you, I guess, balanced SG&A versus either further R&D or just dropping some of those savings to the bottom line as you're considering kind of how to redeploy that $1.5 billion.
Thanks, Chris. Let me just say a couple of words and then I'll turn it over to David for the first part of your question, then Adam can come in on the back end. First, as David mentioned, when we thought about these efficiencies, we were really thinking along three lines: the need to invest in the pipeline; ensuring that we had adequate investment for our growth products; and then needing to be more agile and focused as an organization. In terms of how we think about allocating those redeployment opportunities, I would say, generally speaking, they're in that order with the majority going back into R&D.
But David, do you want to start?
And yes, Chris, thanks for the question. The way to think about it, about 2/3 of the savings associated in the R&D area and about 1/3 is in MS&A. But importantly, if you really think about the acquisitions that we've just done, if you think about Mirati and Krazati, in particular, really important development programs in first-line lung, both the doublet as well as the triplet.
And then if you think about Karuna, and Adam can talk further about this, we see multiple indications -- billion-dollar indications in this space. We talked about schizophrenia, the adjuvant schizophrenia as well is moving into Alzheimer's with agitation and psychosis. So there's significant investments that you have to make there.
And then if you think about radioligand and RayzeBio, we see multiple INDs being able to come out of this. We're also -- we finished the manufacturing facility in Indianapolis. We're going to be able to supply our clinical studies out of that. So significant investments in those three areas, which through all of that as well as reprioritizing our existing BMS portfolio, what we've been able to do is increase the ROI of the portfolio. But just as importantly, we increased the growth profile of the company in the second half of the decade.
So there's a lot of work that's going under the surface in order to continue to maximize the value of the portfolio and strengthen the growth profile of the company. Adam?
Yes. Chris, thanks for the question. So we're making good progress across the totality of our growth portfolio. As David shared, we saw strong year-on-year demand growth across the majority of our growth products. And we continue to be focused on accelerating our key brands. And we're doing what we said we would do as we continue to drive our growth portfolio.
So just a few of the products that I think is important to mention. Opdualag has become a new standard of care in first-line metastatic melanoma, grew 76%. Reblozyl continue to deliver strong performance post first-line. COMMANDS approval grew over 70% as well.
We have increased investment at the end of last year behind products like SOTYKTU, Breyanzi and Camzyos. Camzyos continues to demonstrate strong growth. We had 25% growth of new patients added on to commercial drug quarter-over-quarter. Breyanzi, we also increased our investment. We're a much stronger supply position today than we were last year and increasingly being recognized as a best-in-class CAR-T. And as David mentioned, we're readying for the launch of KarXT in September, which is a very significant multibillion-dollar opportunity.
I would say that a product like Abecma has been more challenging for us. But we have an opportunity now with the KarMMa-3 approval to work to return Abecma to growth over time as we move into a larger patient population. But adding it all up, we continue to make good progress in delivering strong commercial execution and performance.
Our next question comes from Evan Seigerman with BMO.
Kind of a follow-up to what we've been talking about. So when you talk about the cost savings being reinvested, do you mean that you're going to manage your margins by titrating the reinvestment of the cost savings? Are you going to deploy the $1.5 billion kind of informed by the science or potential for growth?
And then a follow-up, as you mentioned you're going to discontinue and externalize several clinical assets. Any commentary as to which ones you're thinking about? That would be great.
Thanks, Evan. We'll have David start, and then Samit.
Yes. Thank you, Evan. As I said in my prepared remarks, we're looking at our operating margins as we previously communicated in that 37% range. So that $1.5 billion of savings that we'll achieve by the end of next year, that's being reinvested both in the portfolio as I described earlier, particularly with the acquisitions that we did. But we've also had good progress like Opdualag lung where we're going to continue those clinical studies as well. And all of that put together, as I was saying, really strengthens not only the ROI, but the growth profile of the business in the second half of the decade. And I'll turn it over to Samit on the assets that we're looking at to externalize.
Yes. Thank you, David. And just to build on what David said, from a pipeline perspective, we took a very thoughtful approach to see -- from our rich pipeline, what are the assets that we are not going to be continuing on our own. So first thing that we looked at is the evolving science from the ongoing exploration of our clinical assets. An example over there where we look at CTLA-4 in our pipeline that we were developing, we had set the bar with ipilimumab, which is already a high bar to then look at the data and then we decided that if the data are not going to be better than ipilimumab, we shouldn't be continuing that program, so we decided not to continue with that.
Similarly, when we looked at external and internal data for the SIRP alpha program, that did not meet the muster, and we wanted to look at the real return on that investment as well for patients. And so we are not going to continue that program.
The second way we looked at it is that the science may be really good. Data evolution is really good, but does it really make sense from -- for a company our size to continue a program if it's not going to be ultimately a growth driver. So from that perspective, if you think about BET 158, where the data are pretty good in myelofibrosis, but really, from our perspective, does not meet the threshold to be a driver for our growth potential. So that program, we are not going to be continuing.
And then, of course, we continue to look at our desire to be either first-in-class or best-in-class product profile. So from that perspective, we continue to focus on what we will continue versus not. Overall, I would say, Evan, that we have about -- discontinued about 12 programs at this time. But it's a continuum. And so throughout the year, we'll continue to look at these same principles and see what else we need to take out from our pipeline and either externalize it or not be able to develop it further.
Our next question comes from Seamus Fernandez with Guggenheim Securities.
So just wanted to check in on your thoughts around IRA and the impacts associated with that as we approach 2026 in particular. And if you might be able to provide us any color on progress or process in the "negotiations" or price fixing that may come from the U.S. government.
And then just the second question, hoping you might comment, help frame for us the Opdualag opportunity in lung cancer and when we might gain some incremental visibility on that. Is it going to be more from clinical trials hitting clinicaltrials.gov, and we'll get some information in that regard first? Or will we actually see the data in this potential subset?
Thanks for the question, Seamus. Maybe I'll start, have Adam weigh in a little bit more on IRA. With respect to the ongoing discussions with CMS, we're not going to be commenting. As I said earlier, we will have the outcome of that public in September and we'll be able to provide more insight at that point. But Adam, you can speak to some of the other aspects of IRA and then Samit.
Yes. Thank you, Chris and Seamus, thanks for the question. As it relates to IRA, there are obviously multiple components to it. There's the negotiation. There's also the change in the Part D benefit design. So in 2024, we don't anticipate significant impact across our portfolio, across Eliquis, Revlimid or other brands. We do expect, though, more substantial changes to the Part D benefit next year since the products are impacted by the redesign. We are carefully evaluating each product individual dynamics now and we'll see into the future. And we're monitoring very closely to understand the impact of, for example, out-of-pocket caps and other shifts that are happening in the system.
So as we move from a $3,500 cap to a $2,000 cap, we would expect to see more patients' ability to fill their medicines and improve as it becomes lower at the pharmacy counter. But obviously, we'll need to do more -- see more data before we can provide additional details.
Thank you, Adam. And then thanks, Seamus, for the question. For Opdualag, let's just take a step back and understand what we were planning to do and try to do. So for Opdualag, we conducted a study of Opdualag plus chemotherapy in first-line non-small cell lung cancer. At first, we wanted to define the dose. So we tested a couple of doses in the first part of the study. And in the second part of the study, then we randomize the patient to receive Opdualag plus chemotherapy versus nivolumab plus chemotherapy.
And as we have said before, what we wanted to understand, is the drug applicable for all patients? Or are we going to find a differential activity in a subset of patients? And what we have said is we have found a subgroup of patients where the drug's activity is good and encourages us to now go into a Phase III trial. And so we are looking forward to presenting the data in the second half of this year as well as initiating the trial versus standard of care in the second half of this year. And we are planning that, we'll be executing that. As soon as we have that ready, you will be hearing about it.
In addition to that, Opdualag, is of course, other opportunities. As you know, we are already waiting for the data for the adjuvant melanoma trial and we're looking forward to the data evolution towards the back end of this year in first-line hepatocellular carcinoma as well.
Our next question comes from Terence Flynn with Morgan Stanley.
Maybe a two-part for me on the CAR-T franchise. David, I think you mentioned something about Abecma ex-U.S. pricing dynamics, some change there to help boost access. Can you just provide a little bit more detail if that was a one-off in a specific country or what's going on there?
And then on Breyanzi, Gilead has talked more recently about moving in the U.S. out to some of these secondary community hospitals as they think about expanding, particularly in the second-line label indication. And so is that something that you guys are considering as well? Or do you feel pretty good about your current footprint for Breyanzi at the primary academic hospitals?
Thanks, Terence. I'll let Adam take both of those.
So as it relates to Breyanzi, what we saw in the quarter was we were able to stabilize the decline in the U.S. Sales were roughly flat versus last quarter. What you're referring to internationally is we did see strong demand growth, which we expect to continue, but that demand growth was offset by negative pricing skewing reimbursement, mainly in Germany. So that's where that took place.
And now with KarMMa-3, it gives us the opportunity to have a different conversation with our customers about our data in a larger patient population. And our objective is to return Abecma to growth over time as we move into this larger patient population.
Now for Breyanzi, we're very excited about this product. In Q1, we increased sales over 50% versus the prior year. We anticipate robust growth this year, because not only just in accelerated growth in DLBCL, as Breyanzi is increasingly recognized as the best-in-class CD19, we also expect to see expanded indications. We just received approval in the U.S. for CLL and with additional approvals anticipated next month in follicular lymphoma and mantle cell lymphoma. And this is going to roughly double the addressable market for Breyanzi.
We're also very encouraged by our expanded manufacturing capacity and now in a much stronger position to meet demand. We're seeing about 20% outpatient use today for Breyanzi, and we expect that to continue based on the differentiated safety profile. So taken together, we're very excited about the growth profile of Breyanzi.
Our next question comes from Tim Anderson at Wolfe Research.
This is Adam on for Tim at Wolfe Research. So just on SOTYKTU, can you give us some updated market share metrics, things like new-to-brand share or versus Otezla in the oral category percent use in first-line versus later lines, that sort of thing? And also, any details on when the free drug program might begin to wind down?
Sure. I'll take that, Adam. Thanks for the question. So we're continuing to make progress with SOTYKTU, and we're executing our plan. We delivered in the quarter what we said we would do, and that's reaching approximately 10,000 paid prescriptions. That's what we shared in January, and we expect to roughly double that to 20,000 paid prescriptions in Q4. So that's where we're focused on driving today.
Remember, we also said there would be an increase in gross to net due to broader rebating needed to secure improved access, and this impacted sales in Q1. But the volume that we'll see will more than offset that throughout the year. So we talked about improving our access position. And aside from the wins that we announced last year in CVS and Cigna and ESI, we saw access improvement with SOTYKTU, which was added to Optum. And as David mentioned, we do expect to announce additional improved formulary access including a large PBM with approximately 30 million lives.
So we remain focused on securing zero steps by 2025. And when you have that better access position, the need for a bridge becomes less and less important. And so basically, when you look at -- when you have better access, patients are moved faster into commercial product because they go directly to the specialty pharmacy.
As far as market share, look, this is a highly competitive market. We look at launch analogs at the top of the funnel or written prescriptions, and SOTYKTU performance is ahead of products like TREMFYA, COSENTYX at the same time ago launch. We are laser focused on share growth versus Otezla, which is a critical area of focus and becoming the oral standard of care in the market over time.
Our next question comes from Dave Risinger with Leerink Partners.
And thanks for all of the detailed perspectives that you're sharing. So I'm hoping that you can help with other income prospects in the future, including the look for AstraZeneca, other incomes, run rate and the anticipated step down in coming years.
Thanks, Dave. David?
Yes. So this year was the big step down in the PD-1 rate. And then the other thing impacting that is the diabetes that will step down next year as well.
The other thing to keep in mind, as I said in the prepared remarks is on the interest for the additional debt that we just did. That was the big change in the guidance that we just provided for this year, going from $250 million of OI&E income down to $250 million of expense. And the bulk of that is related to the additional interest cost, which is around $13 billion with 5.3% interest rate. And that's slightly offset by the royalty income.
And our next question comes from Mohit Bansal with Wells Fargo.
I actually want to probe the trough guidance comment a little bit further. It does seem like that you are considering it. But if that is the case, can you talk a little bit about the puts and takes there regarding timing of such guidance? I'm asking because it depends on when you think the trough is, if it is '26 or '28. Because, I mean, you might not want to provide if it is '28, but just now because it is still a little bit uncertain regarding the timing of it. So what are the puts and takes regarding the timing of it when you eventually decide to provide it?
Yes. So maybe I'll start and then David can chime in if he has any additional -- anything else that he would like to provide. I think the way we're thinking about the trough guidance, and again, it's something that we have been engaged with investors for the last number of months. I think the way I would think about it is, first and foremost, probably the underlying question on guidance right now is what is the impact of IRA on Eliquis. We will, as I said earlier, be in a position in September when the price for Eliquis coming out of the IRA process is known and public, at that point, to talk about what that price is and the impact of -- on Eliquis on both the top line as well as on EPS.
And then in terms of how we're thinking about the timing of the trough, again, and we said this back at the beginning of the year, we see the impact starting in 2026 and our plan is to be growing by the end of this decade. David, anything else you would add?
I think you covered it, Chris.
Our next question is from Carter Gould with Barclays.
I wanted to dig into Camzyos for a second. You did have data at ACC and sort of the current rate or the one with that seemed very positive. And just when you think about that REMS registry data and the potential to potentially get the REMS modified down the road, should we be reading into that data? Any level of confidence or anything on that front you want to message?
And I guess along those lines as well just, I believe housekeeping on -- did I hear a $20 million inventory impact in the quarter? I know that something was called on the slides, but I'm not sure that was quantified. Any help there would be great, too.
Yes. Thanks, Carter. Maybe Samit can start and then Adam. .
Yes. Thank you, Carter, for the question. So for Camzyos, we remain obviously very confident in the overall profile of Camzyos. It has been a very transformational therapy for patients. And as you mentioned, the data at ACC clearly showed from the patients that have been treated in the real world that there is transformational outcome. And from a safety perspective, with 80% of the patients being treated, the 2.5- and the 5-milligram dose, the overall outcomes remain really, really positive as well as the impact on the ejection fraction is minimal at best.
So certainly, it gives us an opportunity to collate that data and find the conversations continuing with the FDA at appropriate times. Remember, we've also got the nonobstructive hypertrophic cardiomyopathy study that we'll be reading out early next year. So that will provide another opportunity for us to also engage deeper into conversations for the REMS program as a whole and how we can bring this therapy to more patients as well as decrease the burden on the patients.
With that, let me pass it on to Adam to comment more.
Yes. Thanks for the question. We're pleased with Camzyos' performance in the quarter. And we saw a nice acceleration in new patient starts. We saw about a 25% increase in patients added to commercial dispense, but that was offset as you mentioned, by approximately $25 million inventory work down from Q4 to Q1. And we saw a slight gross to net impact as well from copay restart that happened at the beginning of the year.
What we see from Camzyos is consistent positive feedback from physicians and patients. It's very positive. We're also making very good progress in the launch internationally as we work to secure reimbursement. So we're seeing good momentum for Camzyos and we feel good about the performance of this important product now until the end of the year, for sure.
And our next question comes from Steve Scala with TD Cowen.
This is a different version of earlier questions, but there are a number of potential obstacles in Bristol's future, Eliquis IRA price and patent expiration, Opdivo patent expiration, other patent expirations, et cetera. But based on your replies to those earlier questions, it sounds like that Bristol views the IRA price of Eliquis as the single biggest obstacle to profits in the next decade. Is that the conclusion that you'd like us to draw?
And then the second question is that it was noted, Revlimid free drug was lower in Q1. Just to confirm, is that consistent with prior Revlimid guidance? And what is the reason it is lower? Was there just fewer patients requesting free drug? Or did Bristol change the terms?
So Steve, I'll start, and then I'll ask the last part of your question. We've highlighted the issue around the Eliquis price and the negotiations, because that is an important consideration in the midterm as we think about this sort of transition period that we're going through that we've talked about in the middle of the decade. And so we'll have greater insight into what that impact is later this year, and we'll be able to provide more of an estimate for the impact both on top line and on EPS as we get into the back half of the decade at that time.
What I would say, though, as I step back, I mean, clearly, you've articulated that -- the importance of Eliquis. And as we've discussed in the past, we have a number of LOEs that we faced during the course of the decade. But I think it's important to note as well that we've talked a lot about the importance of the growth portfolio that we had. We saw nice double-digit growth with that portfolio in the quarter.
We actually are now -- about 40% of the overall business is comprised by that portfolio of products. And remember, this is a diversified portfolio of assets across each of our therapeutic areas, and we feel good about the potential of that portfolio going not only through the end of this year, but to be a catalyst for growth in the back half of the decade. And then we saw very nice progress with the pipeline over the course of the quarter.
So I think it's important to recognize that while IRA has an impact in the middle of the decade, we feel very good about being able to more than compensate for that with a very young and attractive growth profile coming from our growth portfolio and the pipeline. David?
Steve, on your question around Revlimid, just a couple of comments I'll make on that. One is what I said is that the free drug programs come down to normal levels. So no change in the program there. Just throughout last year, those levels came down in the start of this year. Remember, every calendar year, it starts again, back at traditional levels. So that was in relation to that comment.
The other thing as it relates to Revlimid is, as we said, there's no change to our guidance this year. As previously said, it was $1.5 billion to $2 billion step down this year and the same next year. So for this year, if you remember, we exited last year at $6 billion. So we'll be in that $4 billion to $4.5 billion is our best view this year and then a further step down next year.
So we'll be through the LOE of Revlimid basically at the end of next year. And then as Chris talked about, we'll get insight to what's happening with Eliquis from an IRA perspective when that price becomes public here in September. And recall that the LOE for Eliquis is in 2008.
And then lastly, the thing I'd say about from an LOE perspective as it relates to Opdivo, is that LOE is in December of 2028. So '29 is when that LOE would start. And then three things I'd say about that as we think about that franchise. One is we're looking forward to launching the subcutaneous formulation of that early next year. And we believe that will help that franchise continue into the next decade. I think you've heard Samit talk about Opdualag and that combination. We're really excited, number one, with its performance and standard of care in first-line melanoma, but also with the data that we're seeing in lung, we're really excited about continuing that program into Phase III and bringing that. And also, there's other tumor types that Opdualag will come in.
So as we think about that franchise, there's multiple avenues for that franchise to continue into the next decade.
Just adding one thing, Steve. Around Revlimid, we had seen some volatility in generic dispensing in the quarter, including some generic supply shortages. And so Revlimid and our legacy portfolio continues to be a strong source of cash flow for the organization.
And our next question today comes from Trung Huynh with UBS.
Trung Huynh from UBS. Two from me, if that's okay. Just one on the cost saving program. How is that $1.5 billion split between this year and 2025? There's no change to your OpEx guide, but I think you noted savings were absorbed by the deals. Is 2024 the main year you'll see most of these costs realized?
And then just on Abecma, you have KarMMa-3 on the label now. You noted it's going to be important for growth. How quickly can we start to see that helping? Is it realistic to see an inflection immediately?
Thanks for the question, Trung. David, then Adam.
Yes, the vast majority of the savings comes through this year. Because if you think through the actions that we're taking, whether it's positions, the portfolio actions, we made those actions immediately and the third-party spend, we'll receive that. And then you have it annualize fully next year. So that's really the difference between '24 and '25. But it's safe to say that most of all the actions we're taking, 90% of those are being done this quarter.
Yes. Trung, as it relates to Abecma, we're certainly pleased with the regulatory approvals of KarMMa-3 in a triple class-exposed setting in the U.S., in Europe and in Japan. This will remain a very competitive space with multiple products and modalities available. Our focus is on educating physicians on the KarMMa-3 data, Abecma's differentiated and predictable safety profile as well as the manufacturing reliability that we've had with Abecma.
We're also focused on expanding our site footprint in the U.S. and around the globe, making Abecma available to more patients. So we believe that there is a place for multiple assets in this market, and our objective is to return Abecma to growth over time as we move into a larger patient population.
Our next question comes from Matthew Phipps with William Blair.
Adam, I was wondering if you can comment on -- is there any path to grow Opdualag in melanoma outside the United States? Or will additional data be needed?
And then maybe for Samit. On KRYSTAL-12, I don't suppose you can give us any tidbits on trends and overall survival at this point. I know the study is ongoing there, but maybe, if not just confidence in that data set as it stands today being able to support full approval.
Yes. I'll start. Thanks for the question. First, I'd say we're pleased with our continued progress as Opdualag has become the standard of care in the United States in first-line metastatic melanoma. We saw over 70% growth versus prior year. And our market share now is above 25% in the U.S., and we still have further room to grow penetrating what's still around 15% monotherapy use.
It's exciting because we're also starting to launch internationally in markets like Australia, in Canada and Brazil as well as several European markets. We still have not had an opportunity to launch in Germany, but we are working on that negotiation. And we're hopeful that we have an opportunity to launch there sometime in the back end of this year and into next year.
Additionally, as spoken earlier, we're very pleased to have the proof-of-concept study with LAG-3 on top of PD-L1s and chemo in first-line lung cancer. And when you add that up, coupled with opportunities with lung and adjuvant melanoma, Opdualag truly has the potential to meaningfully extend our I-O franchise well into the next decade.
And thank you for the question. If I think about KRYSTAL-12, remember, this is a study with a primary end point in progression-free survival. And you will see the data being presented at ASCO. Overall survival data remains immature at this time, so I will not be able to comment on the specifics of that. But really excited for the confirmation of the single-arm study previously done now with the randomized study here.
Our next question comes from Olivia Brayer with Cantor Fitzgerald.
What does the commercial rollout strategy look like for KarXT as we look past that September PDUFA? And any thoughts around Medicaid negotiations?
And then when do you think we start to see some meaningful growth from that franchise, whether that's next year or more so in 2026?
Adam?
Yes. Thanks for the question. So we're very excited about the opportunity to launch KarXT later this year. This is a very important drug with significant commercial potential. As we talked about, KarXT will be the first innovative therapy in schizophrenia approved for decades. And what we've shared is KarXT offers Zyprexa-like efficacy without the significant adverse event that's plagued the D2 such as weight gain, lipidemia, EPS. And we know how compelling this is for physicians. We are rapidly preparing for the launch and the plans are going well, and we will be ready to launch by the summer, well in advance of our PDUFA date.
We've been focused on prelaunch efforts and made very good progress preparing for the launch. So Karuna had made good progress in sourcing a very experienced commercial organization and our field medical and our access teams have already begun meaningful conversations with thought leaders and payers. Our prelaunch efforts today are focused on driving awareness of this new mechanism. We're currently building out a large neuroscience field sales organization. In fact, we've increased the investment across multiple fronts to maximize the opportunity that we have.
So we also need to ensure that physicians have a positive first experience. So we're focused on building our customer model to make sure that we have the optimal physician caregiver and patient support. And as you alluded to, we know that achieving rapid access is important. And so this is a largely Medicaid and Medicare opportunity, around 70%, and our access teams are ready today. We will leverage our large access organization to ensure rapid access for patients. Our teams have already been out and meeting with state Medicaid directors, and the feedback on the product profile has been very, very positive.
So over half of state Medicaid programs either have no step edits or a single step edit. So our goal is to improve the quality of access to only one step edit, which you know is going to take some time, but we're very confident in our ability to achieve quality access for this product. So given a September '26 PDUFA and some of the timelines to obtain broad Medicaid coverage, we effectively see this as a 2025 launch, but we're very excited about the potential of KarXT and we plan to make this a very big product for Bristol-Myers Squibb.
Thanks, Adam. We're starting to run a little short on time, maybe take 2 or 3 more. Can we go to the next one?
Our next question comes from James Shin with Deutsche Bank.
I had a question on Opdualag Phase II for frontline multiple cell lung. I know the full data set is for readout in the second half, but can you share if what you've seen is any different or comparable to the other LAG-3 non-small cell data sets such as [ TACD ]?
Certainly, I can take that question. Look, obviously, I can't comment on what others have seen. All we know is they've seen six patients worth of data. Hard to compare six patients worth of data with more than 200 patients treated with Opdualag plus chemotherapy in the first-line setting.
What we have seen is overall review of our own data set, looking at the various endpoints that we looked at as well as the biomarkers we looked at in our [ profile ] and we remain confident in the profile of the drug to take it forward into the Phase III.
Our next question comes from Kripa Devarakonda with Truist Securities.
I had a question about your acquisition of RayzeBio and now that you've got enablement and we're seeing -- it's getting to be very competitive. Just wanted to see what the urgency and what this strategy is to build out the radiopharma pipeline. And also, when can we see more details on what the priorities are and also regarding actinium production going live?
Well, let me start and then I'll ask Samit and Adam to speak. Let me just at a high level, though, say, that we continue to be incredibly excited about radiopharmaceuticals as a platform. It's one of the fastest-growing platform in solid tumor oncology. We believe we have a best-in-class asset that we've acquired with Rayze.
The integration of that team has gone very well. We continue to be very excited and happy with the bringing online of the facility in Indianapolis. So in terms of us getting that asset, incredible enthusiasm and the integration has gone well. But Samit, maybe you and Adam can speak to details.
Yes. Thank you for the question. For Rayze, as Chris just mentioned, the platform is absolutely exciting and very encouraging data that we have seen emerging from the first program that is already in Phase III for the SSTR directed radioligand therapy. And that Phase III program is right now enrolling in the GEP-NET indication as well as the small cell lung cancer Phase I studies ongoing, and we are looking to see a couple of other indications added over there, and we're designing those trials as we speak and conduct those. So it holds a huge amount of promise because of the specificity of the directed radiation to the tumor itself.
Thereafter, we're looking forward to additional IND filing later this year, and that might then be able to start our actually very specific tumor-directed indication within HCC at the back half of this year. And then thereafter, we are looking to see an IND generation coming from this platform as we go forward.
With the Indianapolis manufacturing facility now up and running, we're looking forward to supplying the actinium part of it as well as the drug product towards the back half -- or back end to early part of next year, and that will certainly help in terms of continuing to supply and taking it forward. We are learning lessons from the front runners and those lessons will be very helpful as we go into the commercial stages in a couple of years.
Adam, anything to add?
Yes, I'll just add just a few things. RayzeBio was an important strategic acquisition that we believe continues to diversify our oncology portfolio. It's -- as Chris mentioned, we see this as a modality that's going to continue to grow over time. It will be a competitive space.
But what we liked about RayzeBio, this is going to be an IND engine. And the lead program RYZ101 is already in Phase III development, as you heard earlier, for GEP-NET. But we have opportunities in small cell lung cancer, in breast cancer and potentially many other tumor types. So this is tremendously complementary to our existing portfolio.
And maybe we could go to our last question, if you don't mind, Rocco?
Our final question comes from Akash Tewari with Jefferies.
This is Ivy on for Akash. We just have two quick questions. The first one is a follow-up for KarXT. So do you think patients on the drug will develop tardive dyskinesia? If not, how will that help position KarXT in the schizophrenia market?
And then our second question is for CAR-T. So why do you think CAR-T for autoimmune is more attractive than CD19 bispecifics? And also, would you consider approaches that don't require lymphodepletion?
Samit?
Sure. Thank you. First of all, great profile for KarXT that I think Adam has spoken about earlier from a safety profile perspective and the data has recently been presented also at the SIRS conference where we do not see the same toxicities that are seen with the atypical such as the tardive dyskinesia, the movement disorders as well as many of the other elements that have been spoken about, so I won't repeat. So that's why we are very confident on the profile and looking forward to bring it to the patients with schizophrenia. And then as David said earlier, with other indications as well for AD psychosis, agitation, bipolar disorders and others that we are exploring.
On the CAR-T side, certainly an advantage for a single infusion leading to good outcomes for patients, especially starting with SLE in the refractory setting, where patients have had multiple other treatments ongoing and organ dysfunction factors in these patients. That is the advantage, a single infusion, if that can cause tremendous transformational outcomes for these patients.
As you know, our program is quite large. So we are also looking at multiple sclerosis as well as systemic sclerosis as well as idiopathic myositis. So those programs as they enroll patients will generate the data, and we're hoping to be able to present some data from SLE this year and certainly, future approaches might include non-lymphodepletion therapies, but we're not ready for that right now.
Thanks, Samit. And maybe I'll just close by saying, first, thank you all for joining the call today. I know it is a very busy day for all of you. So maybe I'll just leave you with a few things. First, we're off to a very good start in 2024. Our performance this quarter reflects execution and actions that we've taken to strengthen the company's long-term growth profile. Our business out remains unchanged from the beginning of the year. And of course, we look forward to sharing our continued progress on future calls.
And with that, we'll close the call. And as always, the team is available to answer any questions you have following today's discussion, and I hope all of you have a very good day.
Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.