Bristol Myers Squibb Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
April 25, 2024

Key Takeaways

  • Commercial performance was broadly in line with expectations, with key brands like Eliquis, Opdualag, Yervoy and Briyansy showing real strength and inventory patterns normalizing.
  • Pipeline advancement included two cell therapy approvals, initiation of new registrational trials, and promising proof-of-concept data for Opdualag in lung cancer moving toward a Phase III study.
  • Strategic transactions closed four deals to bolster long-term growth, notably Karuna’s CAR XT launch preparations, an operational RAISE radioligand plant, a global bispecific ADC program, and the Mirati acquisition adding Cryzati.
  • Productivity initiative aims to streamline decision-making and optimize R&D, targeting approximately $1.5 billion of cost savings by end of 2025 to reinvest in high-priority growth brands and programs.
  • Full-year outlook remains unchanged, with non-GAAP EPS guidance and low single-digit revenue growth expected, reflecting confidence in top-line momentum despite deal-related charges.
AI Generated. May Contain Errors.
Earnings Conference Call
Bristol Myers Squibb Q1 2024
00:00 / 00:00

There are 19 speakers on the call.

Operator

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.

Speaker 1

Thank you, and good morning, everyone. Thanks for joining us this morning for our Q1 2024 earnings call. Joining me this morning with prepared remarks are Chris Berner, our Board Chair and Chief Executive Officer and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Lankowski, our Chief Commercialization Officer and Sumit Herawat, 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.

Speaker 1

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 representing our estimates as of any future date. We specifically disclaim any obligation to update forward looking statements even if our estimates change.

Speaker 1

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.

Speaker 2

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 4 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. 2nd, we made solid progress advancing our pipeline.

Speaker 2

3rd, we closed 4 important transactions that strengthened our long term growth profile during Q1. And 4th, 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.

Speaker 2

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, Opdulag, Robloxil, Yervoy and Briyonzy. And though the BCMA space remains competitive, our objective to return ABECMA to growth over time with the Karma 3 approval as we move into a larger patient population. Turning to Opdivo, KEMZYOS and Sotiktu.

Speaker 2

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 KAMZYOS normalizing and for SOTIC II, 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. 2nd, we made important progress advancing our pipeline. This includes 2 important cell therapy approvals, the initiation of new registrational trials and important proof of concept data for Optulag in lung cancer from a pre specified analysis of our Phase 2 during Q1.

Speaker 2

We're looking forward to starting a Phase 3 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 the slide, but important for patients is Mobexion, 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. 3rd, we closed 4 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.

Speaker 2

Our team is driving performance of Crozzati. The RAISE radioligand plant in Indiana is now operational. We're in the process of filing an application to supply clinical product for RAYS-one hundred and one from the site. Systemimmune's 1st 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 CAR XT from Karuna, which I will review on Slide 6.

Speaker 2

The team is on track and focused on 2 objectives. 1st, launch preparations are underway and on track for CarXT. 2nd, 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 CAR XT. These data demonstrate its compelling long term efficacy as CAR XT was associated with significant improvements in symptoms of schizophrenia across all efficacy measures without evidence of metabolic or movement disorder side effects.

Speaker 2

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.

Speaker 2

And within R and 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 $1,500,000,000 by the end of 2025, which will allow us to reinvest in high priority growth brands and R and 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.

Speaker 2

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.

Speaker 2

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?

Speaker 3

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 on our momentum coming out of last year, we are executing against our plan to drive our growth portfolio, which delivered approximately 11% sales increase in the Q1 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.

Speaker 3

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 Q1 performance of our key brands and starting with oncology on Slide 11. On this slide, you can see the impact of our strategy in broadening our IO 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.

Speaker 3

As we said in the past, we expect to see growth at a more modest pace in 2024. Optulag, a standard of care treatment in first line melanoma, generated strong quarterly sales with the U. S. Sales growth primarily driven by strong market share. We are very encouraged by the future expansion potential of Optilag, not only in adjuvant melanoma, but also in our plans to develop it in first line lung cancer.

Speaker 3

This, along with the anticipated launch of our Opdivo subcutaneous formulation next year, we will extend our I O franchise well into the next decade. Our targeted solid tumor therapies expanded with the addition of Krizati after the completion of Mirati acquisition in late January. Our reported sales represent a partial quarter and on a pro form a basis, Christophte global sales in Q1 were approximately $27,000,000 primarily in the U. S. With the recent conditional marketing approval by the European Commission, we look forward to bringing Crysvati to more patients toward the end of the year.

Speaker 3

Octyra's Q1 performance reflects positive early sales trends. We remain focused on driving awareness and penetration based upon its potential best in class profile. Worldwide. Q1 sales in the U. S.

Speaker 3

Grew 12%, primarily due to strong demand, including increased market share. Internationally, sales were roughly in line with prior year. KAMZYOS 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 dispensers since Q4 of 2023.

Speaker 3

Sequentially, U. S. Sales of KANZYOS were impacted by the inventory dynamics of approximately $20,000,000 and gross to net impacts from the typical co pay reset at the start of the new year. We expect the momentum of KENSIERS to continue, supported by the compelling real world evidence in over 1500 patients presented earlier this month at ACC. Let's now turn to Slide 13 and discuss our hematology business.

Speaker 3

Our business. Our legacy brand Revlimid saw sales decline in the Q1. 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.

Speaker 3

S. Generics starting in March. Turning to REBLISEL, growth in the quarter was driven primarily by the strong U. S. Launch of the broader COMMANDS label and first line MDS.

Speaker 3

International sales growth benefited from the new market launches and we look forward to bringing REBLISEL to more patients with the recent first line approvals in the EU and Japan. In cell therapy portfolio, global Briyansi sales growth reflected the strength of the clinical profile and improved manufacturing capacity. Consistent with what we previously communicated, starting in Q2, we expect Brianca to benefit from the recent new indications and expanded manufacturing capacity. With Abekma, U. S.

Speaker 3

Performance in the quarter was impacted by ongoing competitive pressures. Future demand will benefit from the recent Karma 3 approval, which expands the addressable patient population. Internationally, Beqmet demand growth was offset by unfavorable pricing pressures to secure access. Now moving to immunology on Slide 14, Sapozia sales in the quarter were primarily due to demand of new patient starts in multiple sclerosis. Sotiktu sales performed in line with our expectation.

Speaker 3

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 30,000,000 lives. Now turning to Slide 15, I will walk you through the remainder of our P and 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.

Speaker 3

Excluding acquired in process R and D, 1st quarter operating expenses increased mainly due to the impact of the recent acquisitions and higher costs 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 Q1 primarily due to lower PD-one royalty rate and the financing costs associated with the recent transactions. Acquired and Process R and D in the quarter was $12,900,000,000 primarily due to the previously disclosed one time charge of $12,100,000,000 for the Corona transaction and $800,000,000 for Systemune. Our tax rate in the quarter was impacted by the one time non deductible in process R and D charge for Karuna.

Speaker 3

Before the impact of acquired in process R and D, our first quarter earnings would have been $1.89 taking into account the impact from the recent transactions, including acquired in process R and 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 operation remained strong with approximately $2,800,000,000 generated in the quarter, resulting in approximately $10,000,000,000 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 $10,000,000,000 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.

Speaker 3

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.

Speaker 3

We anticipate cost savings from these actions of approximately $1,500,000,000 by the end of 2025, thereby absorbing the incremental OpEx expense from the recent deals. These cost savings will come from across the organization, 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 one time impact of acquired in process R and D, our revised range continues to reflect the strong outlook of the business as we told you in February.

Speaker 3

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, REBLISEL, Brianca, KYMZYOS and Sotiktu. And as a reminder, the Sotatercept royalty will be included in the other growth revenue line.

Speaker 3

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 and 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 initiative 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 and E, we now expect approximately $250,000,000 of expense, primarily reflecting the debt financing costs from Karuna and Raised Bio.

Speaker 3

The tax rate was affected by one time nondeductible expense of the Karuna acquired and processed R and 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 and 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 remain 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 company's long term growth profile and bringing truly transformational medicines to patients.

Speaker 3

With that, I'll now turn the call over to Tim for Q and

Speaker 4

A. Thanks, David. Could we go to the first question, please?

Operator

Absolutely. Our first question comes from Geoff Meacham with Bank of America. Please go ahead.

Speaker 5

Good morning, everyone. Thanks for the question. 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 what do you think there's further optimization to come as you guys focus on the new launch portfolio?

Speaker 5

Thank you. Good morning, Jeff. I'll let David answer that.

Speaker 6

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 $1,500,000,000 savings really came into 3 buckets. First was really looking at the portfolio.

Speaker 6

Obviously, with the Mirati, Karuna and with Raised Bayo, we have really important portfolios that we're bringing into the overall portfolio. That gave us 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 made 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 3rd party relationships, continuing to look for efficiencies in 3rd party service providers, and that was the last category.

Speaker 6

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.

Speaker 4

Thanks, David. Can we go to the next question, please?

Operator

Our next question comes from Chris Shibutani with Goldman Sachs. Please go ahead.

Speaker 7

Thank you. Good morning. 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

Speaker 5

level of

Speaker 7

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 use 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 level?

Speaker 5

Okay. Thanks, Chris. I'll take that one. And I think they're embedded in that question maybe 2 things. First is how we're thinking about how we're going to guide around this drop.

Speaker 5

And then there's maybe a second question in there, which is when we think we'll see that drop 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 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 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.

Speaker 5

And once that price is public, and remember that's going to happen in the September timeframe, will 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. But thanks for the question, Chris.

Speaker 4

Right. We go to the next question please, Rocco.

Operator

Our next question comes from Chris Schott with JPMorgan. Please go ahead.

Speaker 8

Great. Thanks so much. Just a 2 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 and D side or on SG and 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.

Speaker 8

So I'm just interested in which products you see having the greatest potential for improvement with further investment and how you, I guess, balanced SG and A versus either further R and D or just dropping some of those savings to the bottom line as you're considering kind of how to redeploy that $1,500,000,000 Thank you.

Speaker 5

Thanks, Chris. Let me just say a couple of words, and 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 and D. But David, do you want to start?

Speaker 6

Yes. And Chris, thanks for the question. The way to think about it, about twothree of the savings associated in the R and D area and about onethree is in MS and A. But importantly, if you really think about the acquisitions that we've just done, if you think about Mirati and CRISATI in particular, really important development programs in first line lung, both the doublet as well as the triplet. Then if you think about Karuna, and Adam can talk further about this, we see multiple indications, $1,000,000,000 indications in this space.

Speaker 6

We talked about schizophrenia excuse me, 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 RAISE Bio, we see multiple INDs being able to come out of this. We're also we finished a manufacturing facility in Indianapolis. We're going to be able to supply our clinical studies out of that.

Speaker 6

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

Speaker 9

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.

Speaker 9

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. OPTILAG has become a new standard of care in first line metastatic melanoma, grew 76%.

Speaker 9

REBLAZIL continues 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 Cetik II, Briyansy and CAMZYOS. CAMZYOS continues to demonstrate strong growth. We had 25% growth of new patients added onto commercial drug quarter over quarter.

Speaker 9

Briansy, we also increased our investment. We're in a much stronger supply position today than we were last year and increasingly being recognized as the best in class CAR T. And as David mentioned, we're readying for the launch of CAR XT in September, which is a very significant multibillion dollar opportunity. I would say that product like Beccma has been more challenging for us. But we have an opportunity now with the Karmad 3 approval to work to return Abekma to growth over time as we move into a larger patient population.

Speaker 9

But adding it all up, we continue to make good progress in delivering strong commercial execution and performance.

Speaker 4

Thanks, Adam. Rocco, go to the next question, please.

Operator

Absolutely. Our next question comes from Evan Seigerman with BMO. Please go ahead.

Speaker 10

Hi, guys. Thank you so

Speaker 11

much for taking the question. 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 $1,500,000,000 kind of informed by the science or potential for growth? Then a follow-up, as you mentioned, you're going to discontinue and externalize several clinical assets.

Speaker 11

Any commentary as to which ones you're thinking about, that would be great. Thank you.

Speaker 5

We'll have David start and then sum it.

Speaker 6

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 $1,500,000,000 of savings that we'll achieve by the end of next year, that's being reinvested both in the portfolios I described earlier, particularly with the acquisitions that we did. But we've also had good progress like Optulag Lung, where we're going to continue those clinical studies as well.

Speaker 6

And all of that put together, as I was saying, really strengthens not only the ROI but the growth profile of the business in second half of the decade. And I'll turn it over to Sumit on the assets that we're looking at to externalize. Thank you, David. And just to just build on

Speaker 10

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-four 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 SERP1 alpha program, that did not meet the muster and we wanted to look at the real return on that investment as well for patients.

Speaker 10

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 our 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-one hundred and fifty eight, where the data are pretty good in myelofibrosis, but really from our perspective does not meet the threshold to be driver for our growth potential. So that program we are not going to be continuing.

Speaker 10

And then of course, we continue to look at our desire to be either 1st 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.

Speaker 4

Thanks, Sumit. Can we go to the next question please, Rocca?

Operator

Our next question comes from Seamus Fernandez with Guggenheim Securities. Please go ahead.

Speaker 12

Great. Thanks for the question. 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.

Speaker 12

Government? And then just the second question, hoping you might, Samit, help frame for us the Opdula lag 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?

Speaker 5

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 Summit.

Speaker 9

Yes. Thank you, Chris and Jamie. Thanks for the question. As it relates to IRA, there are obviously components to it. There's the negotiation.

Speaker 9

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

Speaker 4

the system. So as

Speaker 9

we move from a ability to fill ability to fill their medicines and improve as the cost comes lower at the pharmacy counter. But obviously, we'll need to do more see more data before we can provide additional details.

Speaker 10

Thank you, Adam. And then thanks, Sameer, for the question. For Opdulag, let's just take a step back and understand what we were planning to do and try to do. So for Obdulag, we conducted a study of Obdulag plus chemotherapy in first line non small cell lung cancer. At first, we wanted to define the dose.

Speaker 10

So we tested a couple of doses in the first part of the study. And in the second part of the study, then we randomized the patient to receive OPDULAC 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 3 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.

Speaker 10

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, Opdulag 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.

Operator

Our next question comes from Terence Flynn with Morgan Stanley. Please go ahead.

Speaker 11

Great. Thanks for taking the question. Maybe a 2 part for me on the CAR T franchise. David, I think you mentioned something about Beqma U. S.

Speaker 11

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 Brianca, 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 on the second line label indication.

Speaker 11

And so is that something that you guys are considering as well? Or do you feel pretty good about your current footprint for Briyonzi at the primary academic hospitals? Thank you.

Speaker 5

Thanks, Jaren. So I'll let Adam take both of those.

Speaker 9

Yes. Hi, Jaren. Thanks. So as it relates to Briyonzi, what we saw in the quarter was we were able to stabilize the decline in the U. S.

Speaker 9

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 price and skewer reimbursement mainly in Germany. So that's where that took place. And now with Karma 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 to Beckman to growth over time as we move into this larger patient population.

Speaker 9

Now for Briansy, 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 LBCL as Brianthe is increasingly recognized as the best in class CD19, we also expect to see expanded indications. We just received approval in the U. S.

Speaker 9

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 Briansy. 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 Briansy and we expect that to continue based on the differentiated safety profile. So taken together, we're very excited about the growth profile of Briansy.

Speaker 9

Can we go to the next question, please?

Operator

Absolutely. Our next question comes from Tim Anderson at Wolfe Research. Please go ahead.

Speaker 13

Hi, thanks. This is Adam on for Tim at Wolfe Research. So just on Sotek 2, 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? Thanks.

Speaker 9

Adam? Sure. I'll take that, Adam. Thanks for the question. So we'll continue to make progress with Sutuktu, and we're executing our plan.

Speaker 9

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 what 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.

Speaker 9

So we talked about improving our access position. And aside from the wins that we announced last year in CVS and Cigna ESI, we saw access improvement with Sotek II, which was added to Optum. And as David mentioned, we do expect to announce additional improved formulary access, including a large PBM with approximately 30,000,000 lives. So we remain focused on securing 0 steps by 2025. And when you have that better access position, the need for a bridge becomes less and less important.

Speaker 9

And so basically, when you look at when you have better access, patients are move 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 the TIC II performance is ahead of products like TREMFYA, Cosentyx at the same time of the 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.

Speaker 4

Thanks, Adam. Rocco, could we go to the next question, please?

Operator

Yes, sir. Our next question comes from Dave Risinger with Leerink Partners. Please go ahead.

Speaker 11

Thanks very much 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 outlook for AstraZeneca other incomes, run rate and then the anticipated step down in coming years? Thanks very

Speaker 6

much. Thanks, Dave. David? Yes. So this year was the big step down in the PD-one rate.

Speaker 6

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 $250,000,000 of OI and E income down to $250,000,000 of expense. And the bulk of that is related to the additional interest cost, which is around $13,000,000,000 with 5.3 percent interest rate. And that's slightly offset by the royalty income.

Speaker 4

Thanks, David. We'll go to the next question, please.

Operator

And our next question comes from Mohit Bansal with Wells Fargo. Please go ahead.

Speaker 14

Hey, thank you very much for taking my question. I actually want to probe the trough guidance comment a little bit further. It does seem like that you are guidance? I'm asking because it depends on when you think the trough is, if it is 26 or if it is 28, because I mean you might not want to provide if it is 28 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?

Speaker 14

Thank you.

Speaker 5

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 something that we have been engaged with investors for the last number of months. I think the way I would think about it is, 1st 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.

Speaker 5

At that point to talk about what that price is and the impact 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?

Speaker 6

I think you covered it, Chris. Okay. Thanks.

Speaker 4

Thanks, Chris. Can we go to the next question please, Rocco?

Operator

Absolutely. Our next question is from Carter Gould with Barclays. Please go ahead.

Speaker 13

Good morning. Thanks for I wanted to dig into Kim Zios for a second. You did update at ACC and sort of the current rates are 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?

Speaker 13

Any level of confidence or anything on that front you want to message? And I guess along those lines as well, just I believe just housekeeping on did I hear a $20,000,000 inventory impact in the quarter? I know there's something that was called on the slides, but not sure that was quantified. Any help there would be great too. Thank you.

Speaker 5

Yes. Thanks, Carter. Maybe Sumit can start and then Adam.

Speaker 10

Thank you, Carter, for the question. So for KEMZYOS, we remain obviously very confident in the overall profile of KEMZYOS. 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 with the 2.5 in the 5 milligram dose, the overall outcomes remain really, really positive as well as the impact on the ejection fraction continuing with the FDA at appropriate times.

Speaker 10

Remember, we've also got the non obstructive 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.

Speaker 9

Yes, Carter, thanks for the question. We're pleased with CAMZIO's performance in the quarter. We saw a nice acceleration of new patient starts. We saw about a 25% increase in patients added to commercial dispense, but that was offset, as you mentioned, by approximately $25,000,000 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.

Speaker 9

What we see from Kamsios is consistent positive feedback from physicians and patients. It's very positive. We also are making very good progress in the launch internationally as we work to secure reimbursement. So we're seeing good momentum for CanPalis and we feel good about the performance of this important product from now until the end of the year for sure.

Speaker 4

Great. Let's go to the next question.

Operator

And our next question comes from Steve Scala with TD

Speaker 7

etcetera. But based on your replies to those earlier questions, it sounds like the 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?

Speaker 7

And what is the reason it is lower? Was there just fewer patients requesting free drug? Or did Bristol change the terms? Thank you.

Speaker 5

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 going through that we 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.

Speaker 5

We saw nice double digit growth with that portfolio in the quarter. We actually are now about 40% of the 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 that's coming from our growth portfolio and the pipeline.

Speaker 5

David?

Speaker 6

Yes. And on 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.

Speaker 6

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 a 1 point $5,000,000,000 to $2,000,000,000 step down this year and the same next year.

Speaker 6

So for this year, if you remember, we exited last year at $6,000,000,000 So we'll be in that $4,000,000,000 to 4 point $1,000,000,000 is our best view this year and then 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 2,008. 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.

Speaker 6

So 'twenty nine is when that LOE would start. And then three things I'd say about that as we think about that franchise. 1 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 Summit talk about Optulag and that combination. We're really excited, number 1, with its performance and standard of care in first line melanoma.

Speaker 6

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 optimize will come in. So as we think about that franchise, there's multiple avenues for that franchise to continue into the next decade.

Speaker 9

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 strong source of cash flow for the organization.

Speaker 4

Great. Let's go to the next question, please.

Operator

And our next question today comes from Chung Huynh with UBS. Please go ahead.

Speaker 15

Hi, guys. Trung Nguyen from UBS. Thanks for the question. 2 from me, if that's okay. Just one on the cost saving program.

Speaker 15

How is that $1,500,000,000 split between this year 2025? There's no change to your OpEx guide, but I think you noted savings were absorbed by the deals. Is 20 24 the main year you'll see most of these costs realized? And then just on the Beqma, you have Karma 3 on the label now. You noted it's going to be important for growth.

Speaker 15

How quickly can we start to see that helping? Is it realistic to see an inflection immediately? Thanks very much.

Speaker 6

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 3rd party spend, will receive that. And then you have it annualized fully next year.

Speaker 6

So that's really the difference between 2024 and 2025. But it's safe to say that most of all the actions we're taking, 90% of those are being done this quarter.

Speaker 9

Yes. Sean, as it relates to Abekma, we're certainly pleased with the regulatory approvals of Karma 3 in the 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 CARMEN-three data, Abekma's differentiated predictable safety profile, as well as the manufacturing reliability that we've had with Beqma.

Speaker 9

We're also focused on expanding our site footprint in the U. S. And around the globe, making Beqma available to more patients. So we believe that there is a place for multiple assets in this market. And our objective is to return Abekma to growth over time as we move into a larger patient population.

Speaker 4

Let's go to the next question, please.

Operator

Our next question comes from Matthew Phipps with William Blair. Please go ahead.

Speaker 16

Hi. Thanks for taking my questions. Adam, I was wondering if you can comment on, is there any path to grow Opdulilag in melanoma outside the United States or will additional data be needed? And then maybe for Samit, on CRYSTAL-twelve, 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?

Speaker 9

Yes, I'll start. Thanks for the question. First, I'd say we're pleased with our continued progress as OpTolac 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.

Speaker 9

And we still have further room to grow penetrating what's still around 15% monotherapy use.

Speaker 4

It's exciting because we're also starting

Speaker 9

to launch internationally in markets like Australia, in Canada, in 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 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-three 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, OpTulag truly has the potential to meaningfully extend our IO franchise well into the next decade.

Speaker 10

And thank you for the question. If I think about CRYSTAL trial, remember, this is a study with a primary endpoint of 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.

Speaker 4

Thanks, Sala. Let's go to the next question, please.

Operator

Our next question comes from Olivia Breyer with Cantor Fitzgerald. Please go ahead.

Speaker 17

Hey, good morning, guys, and thank you for the question. What does the commercial rollout strategy look like for CAR XT 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? Thank you.

Speaker 9

Adam? Yes, thanks for the question. So we're very excited about the opportunity to launch CorXT later this year. This is a very important drug with significant commercial potential. As we talked about, Core XT will be the 1st innovative therapy in schizophrenia approved for decades.

Speaker 9

And what we've shared is CoreXY offers Zypressa like efficacy without the significant adverse events that plagued the D2 such as weight gain, dyslipidemia, 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 pre launch efforts and made very good progress preparing for the launch. So Karuna had made good progress in sourcing a very experienced commercial organization.

Speaker 9

And our field medical and our access teams have already begun meaningful conversations with thought leaders and payers. Our pre launch 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.

Speaker 9

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 meeting with state Medicaid directors and the feedback on the product profile has been very, very positive.

Speaker 9

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 attain broad Medicaid coverage, we effectively see this as a 2025 launch. But we're very excited about the potential of CarXT and we plan to make this a very big product for Bristol Myers Squibb.

Speaker 4

Thanks, Adam. We're starting to run a little short in time, maybe 2 or 3 more. Can we go to the next one?

Operator

Our next question comes from James Shinn with Deutsche Bank. Please go ahead.

Speaker 11

Hey, good morning guys. Thanks for taking my question.

Speaker 13

I had a question on OPDUELIX Phase 2 for frontline small cell lung. I know full data set is set for readout in the second half, but can you share if what you've seen is any different or comparable to the other LAG-three small cell data set such as TACI?

Speaker 10

Certainly, I can take that question. Look, obviously can't comment on what others have seen. All we know is they've seen 6 patients worth of data. Hard to compare 6 patients worth of data with more than 200 patients treated with Opdulac 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 trial.

Speaker 10

And we remain confident in the profile of the drug to take it forward into the Phase 3.

Speaker 4

Okay. Let's go to the next one, please.

Operator

Our next question comes from kepara devarukhanda with Chivas Securities. Please go ahead.

Speaker 18

Hey guys, thank you so much for taking my question and for all the color on the call. I had a question about your acquisition of RAVEBIO and now that you've bought 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? Thank you.

Speaker 5

Well, let me start and then I'll ask Sumit 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 RAISE. The integration of that team has gone very well.

Speaker 5

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 and credible enthusiasm and the integration has gone well. But Sumit, maybe you and Adam can speak to details.

Speaker 10

Yes. Thank you for the question. For RAISE, 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 3 for the SSTR directed radioligand therapy. And that Phase 3 program is right now enrolling in the GAP net indication, well as the small cell lung cancer Phase 1 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.

Speaker 10

Thereafter, we're looking forward to additional IND filing later this year and that might then be able to start our very specific tumor directed indication within HCC at the back half of this year. And then thereafter, we're looking to see an IND generation coming from this platform as we go forward. Within 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 the 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.

Speaker 10

Adam, anything to add?

Speaker 9

Yes, I'll just add just a few things. Raised Bio was an important strategic acquisition that we believe continue to diversify our oncology portfolio. 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 RAISE Bio, this is going to be an IND engine.

Speaker 9

And the lead program RAISE-one hundred and one is already in Phase 3 development, as you heard earlier for GEP NET. But we have opportunities in small cell lung cancer, in breast cancer, potentially many other tumor types. So this is tremendously complementary to our existing portfolio.

Speaker 4

Let me go to our last question, if you don't mind, Rocco.

Operator

Absolutely. Our final question comes from Akash Tewari with Jefferies. Please go ahead.

Speaker 18

Good morning. Thanks for taking our questions. This is Ivy on for Akash. We just have two quick questions. The first one is a follow-up for CAR XT.

Speaker 18

So do you think patients on the drug will develop cardiac dyskinesia? If not, how will that help position CAR Xt in the skin refranial market? And then our second question is for CAR T. So why do you think CAR T for autoimmune is more attractive than CD19 bispecific? And also would you consider approaches that don't require lingual depletion?

Speaker 18

Thanks.

Speaker 10

Sanit? Sure. Thank you. First of all, great profile for CAR XC 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 tardial dyskinesia or 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.

Speaker 10

And then as David said earlier, with other indications as well for eddy psychosis, agitation, bipolar disorders and others that we're 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 that occurs 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.

Speaker 10

So those programs as they enroll patients, will generate the data and we are hoping to be able to present some data from SLE later this year. And certainly future approaches might include non lymphodepletion therapies, but we're not ready for that right now. Thank you. Thanks, Amit. And maybe I'll

Speaker 5

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 outlook remains unchanged from the beginning of the year.

Speaker 5

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.

Operator

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.

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