Bristol-Myers Squibb Co. Q2 2026 Earnings Call

Welcome to the Bristol Myers Squibb second Quarter 2020 earnings conference call. All. Participants will be in a listen only mode Should you need assistance, please signal a conference specialist by pressing the star key followed by zero after two. Today's presentation. There will be an opportunity to ask questions To ask a question, you may press star. Then one on your telephone keypad To withdraw your question, please press star. Then two. Please note this event is being recorded. I would. Now like to turn the conference over to Chuck Triano, Senior Vice President and Head of Investor Relations. Please go ahead.

Thank you and good morning, everyone. We appreciate you joining our second quarter 2020 earnings call. With 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 is Adam Lenkowsky, our chief commercialization Officer. And Cristian Massacesi, our Chief Medical Officer and head of Global Drug Development. Earlier this morning, we posted our quarterly slide presentation to bms.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll remind everybody that during this call, we will make statements about the company's future plans and prospects that constitute forward looking statements. Actual results may differ materially from those indicated by those forward looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date, and we specifically disclaim any obligation to update forward looking statements. Even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items.

Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com. Finally, unless otherwise stated, all comparisons are made from the same period in 2025 and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. All references to our personnel are on a non-GAAP basis. And with that, I'll hand it over to Chris. Thanks, Chuck.

Good morning, everyone, and thank you for joining our Q2 2026 earnings call. We delivered another excellent quarter driven by disciplined execution across the business. Our progress towards transitioning the portfolio to fuel durable, long term growth is reflected in our growth portfolio's strong Q2 performance. At the same time, we're delivering strong performance from our existing business. We're also advancing a broad and differentiated pipeline while maintaining financial flexibility to invest in the highest value opportunities for patients and shareholders. Together, these efforts continue to strengthen the foundation we're building and increase our confidence in our ability to grow the company as we exit the decade. Let me walk you through some of the highlights of our performance, beginning with our Q2 results on slide four. Our growth portfolio continued its strong performance with sales up 14%. Key assets, including Reblozyl, Breyanzi, Camzyos, Opdualag and Movantik continued to perform well with ten products in our overall portfolio, achieving double digit growth. This performance demonstrates both the value creation of our portfolio and the continued execution of our commercial organization. Based on the strength of our results, we are increasing our full year 2026 revenue and adjusted EPS guidance. David will provide additional details shortly.

Building on our in-market performance, our pipeline of differentiated assets is an important driver of our long term growth, and we're making significant progress there as well. We had an exciting Asco in June where we shared data that reinforces the breadth of innovation across our leading oncology franchise. To highlight a few examples in hematology, we presented positive phase three data from the Msigdb successor two study evaluating musique De for patients with relapsed or refractory multiple myeloma. The study showed a statistically significant and clinically meaningful improvement in progression free survival. This further strengthens our confidence in the cell Mod class and its potential to drive the advancement of future myeloma treatment in solid tumors. We saw encouraging phase three data from two isoprene studies supporting our strategy of building differentiated ADC capabilities across multiple difficult to treat solid tumors. We are also initiating our fourth global phase three study in first line EGFR mutant non-small cell lung cancer for which we shared encouraging early phase two global data in combination with chemotherapy for first line non-small cell lung cancer. And in terms of our expanding development program, we are initiating a new phase two novel novel study combining with.

Our CCR eight antibody. These programs reinforce the power of our innovation engine and support our strategy of combining different modalities to deliver transformational medicines and improve patient outcomes. Turning now to our near-term pipeline milestones. We anticipate during the remainder of 2026 on slide five, we've talked about our ambition to translate a data rich pipeline into durable, long term growth drivers, and we continue to expect pivotal readouts across our therapeutic areas by the end of this year. These near-term readouts represent compelling opportunities, including at present, a potential first in class medicine that could redefine the standard of care in pulmonary fibrosis. Our local and relapsed or refractory multiple myeloma. Iberdomide progression free survival data milvexian and secondary stroke prevention. Res 101 in Gep-nets. And sotyktu and lupus, a disease affecting millions of patients with very limited treatment options. Each of these pipeline opportunities carries the potential to redefine treatment standards, addressing large, underserved, patient populations and helping to accelerate our long term growth trajectory. Together, they represent multibillion dollar peak sales potential and reflect the full depth and breadth of what we're building for Milvexian. We now expect the atrial fibrillation study to read out in the first quarter of 2027.

This is an event driven study, and the updated timing from late 2026 reflects the pace of events. As a reminder, the study is being monitored by an independent data monitoring committee, which continues to endorse the study and with the passage of time as the study progresses, we are increasingly encouraged about Milvexian as potential and look forward to seeing the results of this important study. With respect to the development program in Alzheimer's psychosis, based on the pace of enrollment in the adept two and four studies and relapse events accruing more slowly than projected in adept one, we now anticipate top line data readouts from the Adept program to begin in early 2027 and be spread across the year, with the potential interim analysis for adept one later this year. While we await those readouts, we look forward to sharing safety and efficacy data later this year from the open label lead in portion of adept one, as well as data from adept three, which is the open label rollover study for patients who have already completed the adept one, two, and four studies. These data reinforce our continued confidence in the potential for this medicine in Alzheimer's psychosis.

Finally, our phase three. Balsam one and two studies evaluating cobin in bipolar one disorder continue to enroll well, and we anticipate reading out in the first half of 2027. In addition to these upcoming data readouts, we're also beginning to see the next stage of our pipeline strategy come into focus. As recent clinical progress translates into regulatory decisions. We are awaiting the August 17th date for Iberdomide and are ready for the launch of this important medicine, which has the potential to be the first commercialized cell model. This would represent a brand new class of treatment for myeloma, a historically difficult to treat illness with a patient population that could significantly benefit from new innovative options. And we're pleased that the FDA accepted our NDA for Msigdb with the date of May 13th, 2027. Together, Iberdomide and Msigdb continue to reinforce our confidence in the long term potential of our protein degradation platform. The FDA also recently accepted our supplemental NDA for Camzyos and adolescents with obstructive hypertrophic cardiomyopathy and assigned a September 30th PDUFA date. At the same time, we continue to actively plan our previously announced phase three study evaluating Camzyos in patients with Non-obstructive hypertrophic cardiomyopathy and expect to initiate the study by the end of the year.

I want to step back for a moment and take stock of where we are and why I'm energized by what's to come. Our growth portfolio is delivering today and our differentiated pipeline is on the verge of multiple pivotal readouts with the potential to introduce more than ten new medicines by the end of the decade, including Iberdomide and Mesigyna, both of. Which have upcoming due dates. In addition, we also anticipate over 30 meaningful life cycle management opportunities during that same period. Our priorities are clear continue executing with discipline and translate differentiated science into transformational medicines for patients. Turning to slide six. We continue to evolve how we operate as a company. Over the past few years. We've made significant progress rewiring BMS into a more agile, focused and efficient organization. This includes expanding the use of AI to help our teams move faster, execute better, and operate more effectively. Over the past several years, BMS has embedded AI across its research and enterprise operations and demand for compute has grown alongside the scale and maturity of our AI capabilities. In support of this expansion, we've recently announced partnership agreements with both Anthropic and Nvidia. Concretely, this will help our scientists do three things.

Understand disease biology more deeply. Design and test candidate molecules faster, and make earlier, better informed decisions about which programs to move forward. At the same time, we remain disciplined in how we manage our resources. Our focus on productivity continues to generate meaningful savings when combined with our strong free cash flow generation and balance sheet. These efforts continue to fortify the company's financial foundation. Before I turn the call over to David, I'll emphasize that the strong financial foundation we've built provides us with the optionality and flexibility to continue investing in growth drivers, pursuing business development opportunities, and returning cash to shareholders. And with that, David, over to you.

Thank you, Chris, and good morning, everyone. We delivered another strong quarter with results continuing to highlight the underlying strength of our growth portfolio. Comprised of many products that are early in their life cycles. Our performance is also supported by disciplined investment and growth oriented initiatives. Results were further bolstered by Eliquis. Based on this first half, momentum and confidence in our second half outlook, we are raising our full year guidance for both revenue and adjusted diluted EPS. Let me begin with a review of our second quarter results. Starting with slide eight. Total revenue in the second quarter increased 5% year over year to approximately $13 billion, with strong performance of our growth portfolio, offsetting legacy portfolio decline, growth, portfolio revenue rose 14% to $7.6 billion. Now representing nearly 60% of total revenue. As Chris referenced, multiple products contributed to this growth, as this portfolio continues to emerge as a broadening foundation for durable long term growth. Further supported by the broad pipeline within the legacy portfolio. Eliquis delivered demand driven growth of 21%, which nearly all set declines from generic entry across the remainder of the legacy portfolio. Despite full generic availability in the US. Revlimid revenue remains more resilient.

Turning to product performance on slide nine, starting with oncology, Jovancic continued its strong launch trajectory with revenue of $261 million and is now annualizing at over $1 billion for Opdivo revenue decreased 4% to approximately $2.5 billion, primarily driven by continued conversion to Jovancic in the US. In the quarter, we saw some inventory build at the wholesale level, reversing some of the drawdown we referenced in the first quarter. We delivered another quarter of strong double digit growth, which continues to be driven by demand globally, and its leading position as a standard of care and first line melanoma in the US. Turning to slide ten. Reblozyl grew 29%, reflecting solid uptake in first line MDS associated anemia Continued strength in the second line setting and further penetration in the first line Rs negative population. Grenze posted 41% growth in the second quarter, driven by its best in class profile and strong demand across proved indications in both the US and international markets. As in prior years, we anticipate the typical summer demand patterns to moderate growth in the third quarter. Moving to cardiovascular and immunology on slide 11. Eliquis revenue was approximately $4.5 billion, up 21%, driven by strong demand through continued market share gains as a result of the price decrease implemented at the start of the year.

US second half sales are expected to benefit from the elimination of the accumulated CPI penalty in certain government channels, Camzyos revenues increased 59% to 416 million, reflecting continued promotional efforts. New patient prescriber additions and deeper penetration into the community setting. Now moving to immunology, global revenue for Sotyktu grew 23%. We are supporting the recent indication for psoriatic arthritis in adults, and we look forward to the phase three readouts in lupus later this year. I will wrap up our product performance review on slide 12 with neuroscience. Kvanvig grew 81% to $63 million in revenue in the quarter, reflecting continued steady progress in the schizophrenia market. Let's now move to the PNL on slide 13. Gross margin in the second quarter was 71.4%, reflecting product mix operating expenses for the second quarter were $4.1 billion. We continue to benefit from our strategic Productivity Initiative, which provides us both the ability to reduce expenses and identified areas, as well as the flexibility to invest in multiple growth oriented opportunities. Our effective tax rate in the quarter was 16.5%, reflecting jurisdictional earnings mix. Overall, diluted earnings per share were $2.04 for the quarter. Now, turning to the balance sheet and capital allocation highlights on slide 14, we remain in a strong financial position with approximately $11.5 billion in cash equivalents and marketable securities as of June 30th.

In the second quarter, we generated approximately $3.4 billion in operating cash flow and paid down an additional $1.2 billion in debt in terms of capital allocation, we maintain a strategic and balanced approach to deploying our strong cash flows, business development remains a priority, and we are regularly evaluating opportunities in the therapeutic areas we know best while continuing to return cash to shareholders through our commitment to the dividend. Moving to guidance on slide 15. We are increasing our full year 2026 financial guidance for both revenue and adjusted diluted EPS based upon our strong first half results and our current projections for the balance of the year, while maintaining our projections for gross margin, other income and expense, and our tax rate incorporated into these revisions are projected higher. Eliquis revenue growth of 20 to 25% and a less pronounced total legacy portfolio revenue decrease, now expected to be between 4 and 6%. We have slightly increased our projected operating expenses for the year to account for accelerated prelaunch activities, supporting our cell mods. Alberta and the. Expanding permitted development program and opportunities to further support the growth portfolio and reiterate Chris's comment. Our strategy remains focused on driving execution across the organization to build momentum in our growth portfolio and advance our pipeline, while maintaining financial flexibility to balance investment and future growth with disciplined, shareholder friendly capital allocation.

In closing, our strong performance in the quarter reinforces our confidence to deliver long term value for our patients and shareholders. And with that, I'll now turn the call back over to Chuck for Q&A.

Thanks. David.

And everybody, if you could please help us post questions, Operator, and we'll get started with the Q&A session.

We will now begin the question and answer session. To ask. A question you may press star, then one on your telephone keypad If you are using a speakerphone, please pick up your handset before pressing the keys. We ask that you please limit yourself to one question and to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question today comes from Jeff Meacham with Citibank. Please go ahead.

Hey, guys. Thanks for the question. Congrats on the quarter. Chris or Cristian. I just I guess I just wanted to talk about the the depth and milvexian studies going into 2027. I know they're event driven, but maybe can you talk a little bit about, you know, what this means relative to your initial assumptions? Is there something in the patient population maybe that, has changed or that, you know, is perhaps different than what you guys initially assumed? Just wanted to get a little bit more context for both of those. Thank you.

Good morning, Jeff, and thanks for the question. Cristian.

Good morning Jeff. Thanks for the question. Let me start with the with the with the. That first, let me explain the reasons for the delay Chris I. Highlighted in the. In his opening remarks, let me dig into it in depth one. You know we are recruiting events, psychotic relapses, and we are having now slower pace of our recruiting. These events than predicted. So this is can be seen overall as a positive way. And any adept one will be the first interim analysis to readout by the end of this year or beginning of next year. In adept to an adept for is different because like for the rest of program, the first priority has been to ensure the highest quality in terms of the patients we are included in the trial. The conduction of the study. If you think about it, this is one of the best ways to ensure for these trials. The highest chance of success. And then this is very important. Also to support the registration. So this scrutiny in preserving quality and increasing quality impacted enrollment phase. The second point I want to make is about where we are now. I think we have implemented now several measures to accelerate this enrollment.

And I think the pace and the projections on timelines are solid. And finally, related to your question on that program, overall, there has been no change in any way in our confidence in both the underlying science, the scientific rationale, and also the study designs that we are implementing in a adept program. We continue to believe the we can provide a substantial benefit to patients with Alzheimer's disease and psychosis. And actually, this is the main reasons we decided to share the open label data of adept one and the rollover adept three data in one of the next meeting of forums later this year. Moving to Milvexian. As you. As you said, and Chris said, first of all, we remain blinded. But these shifting into first quarter 27 of AFib. Timelines is again, simply reflection of the way the pace we are recruiting events that is lower than predicted. DMC continue to oversee the. The. The study in a regular way and continue to endorse the conduction of the study. Eye. See favorably this delay because actually give us a more confidence that we are a target for both the primary endpoint Non-inferiority and the secondary endpoint superiority of Bleedings.

I remain very excited. Malbecs can. Be the first factor 11 drug to be at parity on efficacy with Eliquis Eliquis on Bleedings.

Great. Thanks for the detail. Cristian. Let's take our next question, please. The.

Next question comes from Chris Schott with J.P. Morgan. Please go ahead Great. Thanks so much. Just following up on Milvexian, I guess beyond just the Non-inferiority primary endpoint is a debate on the street of what type of hazard ratio you need to see for this drug to get broad adoption, cannibalizing sizable pieces of Eliquis. Versus just targeting maybe an underserved segment of the market. Can you just help frame out what you think you'd need to see from that study for this to be a very large opportunity for Bristol versus what would be maybe more of just an incremental new product for, for the company, just in terms of, you know, how strong that data has to be. And if I just throw a second one really quickly on the guidance increase, can you just talk a little bit about the drivers of the upside for the growth portfolio that's implied in the guidance, I guess, is there any standout assets that that that are driving that upside? Thanks so much.

Thanks for the question, Chris. I'll ask Adam to start. And.

Then David, you can jump in on guidance.

Great. Thank you Chris. Good morning. So Milvexian represents a significant commercial opportunity. And we know there is a need for a medicine that has low bleeding risk lower than Eliquis., and can play across both AFib and SSP. As far as the atrial fibrillation opportunity, this is a very large market. There are approximately 10 million patients diagnosed and treated in the U.S. We know this market well. We know the customers well, and we know what it takes to compete and win. Fear of bleeding continues to be the main reason why clinicians continue to hold back from using more factor ten, as in more patients. And despite what we see today with Eliquis, there's still roughly 40% of patients who should be anticoagulated who are undertreated there. Under with discontinued treatment. And that's driven largely by physician concerns around bleeding risk. And so, you know, I don't think it makes sense to speculate on hazard ratio, but you know, what I can say is, you know, our study, as Cristian mentioned, was designed to demonstrate a superior bleeding profile compared to Eliquis with comparable efficacy. And so, you know, AFib patients with bleeding liability risk factors are more likely to experience HCP hesitation today for anticoagulation treatment.

So for example, patients who are elderly, low body weight represent a high unmet need. Patients who have renal impairment and milvexian has the potential not just to unlock those patients, but also we expect Milvexian to shift first line decision making over time, allowing physicians to initiate and maintain milvexian treatment more confidently than they can even do today. By using Eliquis.

Thank you. And on guidance Chris. Look, it was you saw on the results. It was pretty pervasive across the growth portfolio. We saw really strong growth. You know, Optilab was up 22%. Reblozyl 29. Breyanzi we continue to see great growth there at 41%. And Camzyos was at 59%. And, you know, as we also talked about, the Kuvan. Now we got 15% share. So well, on our way to that 30 to 40%, it's now annualizing over a billion. So if you look at Tech and Opdivo together, we're really pleased with the progress of that franchise. So it really is the underlying business coupled with the strong performance of from a demand perspective on Eliquis, that gives us confidence in our guidance for the year.

Thanks, guys Let's take our next question, please. Operator.

The next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead.

Hi, guys. Thank you for taking my question. I'm going to not ask one on Milvexian or the adept program, but taking a step back. You've been clear that BD remains a really important part of your long term growth strategy. Can you just walk me through what what excites you in biotech these days and kind of where you would look? I know you're not going to give specifics, but what type of technologies or therapeutic areas do you think would best fit within Bristol's portfolio? Thank you.

So maybe I'll start and then I'll ask Kristian to chime in. Look, thanks for the question, Evan Business development. As you know, and as we've discussed repeatedly, continues to be a top allocation priority., you know, the way I think about BD just at a macro level is we've got a very strong late stage pipeline. You see that in the commentary that we've made just this morning., we certainly don't feel any compulsion to chase deals. But as we've said consistently, if there's an opportunity that we can find that has a few things that are important to us, notably, there in therapeutic areas that we know well, there are areas where the science is compelling. And of course, we need to be able to make a compelling case financially that we can drive value to the company and to shareholders. If those things come together. And ideally continue to enable us to de-risk our near-term growth profile, we certainly have the financial flexibility and the capabilities to be in the mix. And so that's been our guiding philosophy around business development. For some time now. And it continues to be our focus. But Cristian, are there particular areas you would highlight.

And thanks, Evan, for the question. And there are I would frame In two way. I'm excited by what is new, what is innovative in terms of new targets, but also the way you deliver your drugs against that target. The modalities. I think this is this is where I think,, internally also looking external innovation is very, very continue to be very important. I want to give you some concrete examples. We know better and better the biology of the diseases where we are operating. I think cancer thing. Neuroscience. Cardiovascular. Now it's a identifying targets that are becoming more and more relevant. And then the way we deliver against them. I want to give an example of an internal product that is our cell model BCL six is coming from our protein targeted degradation platform, you know, cell six is a key target in lymphomas drive lymphomas. But because it's description factor, we were unable to inhibit them. Now with that we can. This is just an example. Imagine the potential in neuroscience. We are building up our Alzheimer portfolio. And you know, we start to understand it more and more on the biology of Alzheimer. Now, the question is, how can we deliver against amyloid, against tau, against new targets, and how we can have a better drugs to get into the brain.

The shuttles is an example. So these are the kind of, I hope I gave you concrete examples on what I think innovation can look like, especially looking then at the development path that ultimately is our our job.

Thanks, Cristian.

Let's take our next question, please.

The next question comes from Emily Field with Barclays. Please go ahead.

Hi. Thanks so much for taking my question., a question on in the approved schizophrenia. Indication., you've talked about one of the drags on sales being that,, you know, clinicians aren't titrating up quickly enough to the therapeutic dose. So I was just wondering if you could give us an update on how the,, you know, educational efforts on optimizing that are going and when perhaps we could see that reflected in the sales trajectory. And if I could just sneak in another one on Tyk2 in lupus,, obviously a lot of, readouts coming in the lupus space over the next couple of years. So I was just wondering if you could,, highlight your confidence in the Tyk2 MOA,, in this obviously notoriously difficult space. Thank you Good morning Emily., so, Adam, maybe you could start in Cristian. You can chime in as well.

Sure. Emily, let me just take the first part of your question about company continues to deliver steady growth. And, you know, we see significant upside coming from future label expansions. What we're seeing today in schizophrenia is a number of positive leading indicators for the brand that continues to give us confidence. We're encouraged by the positive trends in total script volumes. In fact, in the quarter, we saw roughly a 15% growth in TRX quarter over quarter. We're driving consistent increases in new prescribers and physician feedback continues to be positive. That said, we have areas where we need to make further progress. We need to accelerate. New patient starts as well as improve, repeat prescribing. As we shared before, this is a disease state that prescribing behavior is deeply entrenched and will continue to grow by building more positive experiences in the market. As far as dosing, we have been educating physicians on the importance of rapidly titrating to the effective dose of 125mg. As we see. Far too many patients that remain on either the 50 or 100 milligram dose. But we have seen, though, is an increase in 125 milligram prescribing since introducing our phase four switch study, which will both help maximize efficacy.

But we need to see further increases in the dose shift towards the 125mg. But taken together, we have a meaningful opportunity to continue to build confidence and bring clarity on how to maximize use. And overall, we do expect to grow consistently throughout the year with significant upside through a very broad LCM program. As far as Sotyktu in lupus. This is a market that is very different than the. So market, so Tyk2 remains really a strategically important asset, which we believe could see renewed momentum with our new indications, SLE, which we'll read out this year, and Sjogren's will read out next year in particular, a real need exists for more effective treatments. Those include treatments that reduce steroid dependence. That includes treatments that are associated with fewer side effects. And what we saw in our phase two study gives us a lot. Of confidence That study was one of the largest and most compelling in SLE to date. Having met both the primary and key secondary efficacy endpoints. So we believe we have a real opportunity to differentiate Tyk2 based on overall clinical responses. Efficacy in skin and joint involvement, the ability to reduce steroid dependence, and also associated toxicity.

So we very much look forward to our SLE data readout this year, as this could really catalyze growth for the brand.

Thanks. Thanks, Adam, and thanks, Emily, for asking about this important readouts that will happen this year. Both both studies ,, as a as Adam. Said the confidence stays on the phase two Adam is playing very well. Why? The phase two were,, positive and positive for for primary or secondary endpoints. It's not very typical in this space now. I what I'm pleased is on the fact that we have been able to mimic the phase two study into the phase three studies. This is a very important because when I look at patient demographics and disease characteristics, a trial management endpoints, everything is very matching. And there are, you know, in immunology you have some kind of risks sometimes related to placebo response. I think that our teams and investigators did a very good job in managing that risk in terms of checking carefully, steroid tapering, and actively monitoring the primary endpoint. So really looking forward on the readouts this year. And I think, as Adam said, that this can be a very important oral drug to bring these patients.

Great. Thanks. Both., let's move to the next question. Operator. Thank you.

The next. Question comes from Asad Haider with Goldman Sachs. Please go ahead.

Great. Thanks for taking the questions and congratulations on the quarter. Maybe for Cristian on Admiral Parent., this now seems to be becoming the key clinical event for the balance of the year. Given the updates that you guys just described. So just perhaps just level set us on expectations as we sharpen our pencils ahead of this readout., you know, can you contextualize where this fits into the IPF landscape? If the clinical benefit turns out to be in line with currently available drugs, which have improved FVC by roughly 40 to 50%, what would be the use case for adding it in? And then on the PPF side, is that trial still tracking to read out closely after IPF? And then anything you can tell us on the filing strategy? Thank you.

Thanks. I'll start with Cristian and then maybe Adam can chime in as well.

Thanks. Thanks, for the question. You're right. This is becoming a very important readout and guided by the end of this year. Let me start with the mechanism of action. LPA one is a very important,, novel target because it's not working only on the fibrotic and inflammatory pathway, but also potentially on the epithelial repair pathway. And this is novel. We believe that Amy. Can be first and best in class., against LPA. One. And the conviction on the phase three again sits on the phase two results, both in IPF and PPF. You know, the results were very positive for FVC primary endpoint. What we did and we were able to do also in this setting was ensure consistency. How we run the phase two into the phase three. Again, in terms of endpoints, population, overall criteria, there is an important aspect I want to highlight. In phase three, we have two shots on goal in each of the studies. IPF and PPF. Because we are testing two doses, 60mg. That is the dose that emerged from the phase two might also 120mg. That was introduced later. We know. That there is a dose relation.. Activity. And this gives us a more chances with both doses.

Also looking overall at the study conduction and how the blinded data are emerging on the safety side very well ., over. All I have to say I'm really looking forward to this readouts because the profile of this drug can be very harmful for patients with both IPF and PPF to IPF guided this year, PPF to the second part of your question will be just a few months after. So very, very same ballpark timelines beginning next year. Adam you want to speak about the positioning?

Yes. No. Thanks for the question. So Milbrandt has the potential to play a truly meaningful role in both IPF and PPF, as we expect an improved efficacy and tolerability profile. There's still a significant unmet need for new and improved therapies that slow disease progression, potentially even halting disease progression that are well tolerated and ultimately help patients better manage their disease. Remember, GI tolerability remains a significant challenge with current agents in the market, and in fact, 50 to 60% of IPF patients continue to stop their medications by 12 months. And that's with current standard of care. And what you've seen in the most recent launch, it clearly validates the market opportunity that there is an opportunity to gain significant share as better tolerated. And in more effective new treatment options emerge. And so what we're seeing happen in the market today is the emergence of a large second line. Add on and switch market for the first time, we're seeing that with over 50% of their starts are coming after generics. So today this is a roughly $4 billion market. We expect this market to grow significantly with improved treatments that could maybe double to 8 to $10 billion by the middle of the 2030s, with improved treatment options.

And we believe that it truly has the potential to be foundational as a first branded option with the versatility of being used in combination. So we very much look forward to the readout in the back half of this year.

Thanks, both., next question please.

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

Oh. Thanks so much for the question. So,, wanted to drill in a little bit on the cell mods., you know, we've got two assets that are either filed or fillable with the agency., just wanted to get a better sense of how in, you know, let's say 2028 to 20, 30,, how? You see the cell mods actually contributing to the growth revenue for the company. This does seem like a multibillion dollar, perhaps even a double digit billion dollar potential opportunity if the earlier stage studies read out positively ., but even in the existing indications that you see today, what kind of contribution do you see coming from your Samad portfolio? Thanks.

Thanks, Seamus., great question. And obviously we're quite excited about the platform and both IBR and messy, but Adam, you can chime in.

Yeah. No, thank you Seamus for the question. So clearly cell mods represent a significant commercial opportunity, and we're confident that both Iberdomide and will deliver very strong growth for the company. And we're very much looking forward to Alberta meds for date, which is just a few weeks away. And our commercial teams are launch ready. We're also pleased to have a date set for Msigdb. As you heard earlier on the call, which will come in May of next year. Let me just step back. Recall that 70 to 80% of patients are treated with multiple myeloma in the community. And both IBR and Mezi are able to provide a balance of high potency. We're able to provide a manageable and very familiar toxicity profile. That are able to provide better experience for patients with the convenience of an oral treatment that fits within the workflow of their practice. So IBR will replace Pom list and Revlimid in the leading triplet regimens in second line, and combined with Daratumumab and will amplify the efficacy of current imid based regimens. Our goal is to make IBR and Mezi foundational in multiple myeloma, replacing rev and pom in second line over time, you know, we do expect strong adoption in the community and PFS data should be available within just a few months after our approval, which will certainly help accelerate uptake as some physicians are going to want to see PFS data before adopting.

But, you know, we are ready to launch. We know the work we need to do to establish both IBR and Mezi in the market. So we're also excited about the upcoming readouts for. Which will be the third cell mod in the market that has the opportunity to really revolutionize first line Lbcl and also play a significant role in second line follicular lymphoma. So we're excited to bring these important medicines to patients. And we know these three drugs will provide meaningful contributions to growth for the company.

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

The next question comes from Michael Yee with UBS. Please go ahead.

Thanks. Two questions, both for Cristian., on IPF. Can you just talk a little bit about the 120 dose that you're using and how you feel about,, how much more efficacy that could add and what exposure analysis data you might have seen there in the context of also blood pressure questions and how you feel about the risk benefit of the 120. And then just perhaps a clarification on, on Milvexian. I know that everyone's asking about hazard ratios, but just so that you could confirm, I would assume that as a non-inferiority study, you expect the hazard ratios, certainly on the upper bound to be well above 1.0. But as long as it's noninferior that that is a win for you. Just wanted to clarify and confirm. Thank you.

Thanks, Mike and Cristian. You can start. And then Adam, you can just chime in with any additional detail on Milvexian.

Thank you, Mike, for the question. On IPF. I, I, as I said, we introduced 120 milligram dose., based on,, some work coming modeling work showing that there was a dose relation, if you remember, in the phase two, we tested 30mg, 60mg, 60mg was the dose showing better? And higher benefit. And this is what we brought in phase three. Then at the start of the phase three, there was a randomized run in introducing 120 DMC. In this data and the clear that dose. We believe that there is a dose relation. The real. As you mentioned, the real unknown for the conduction of the study was 120 safety profile. In terms of hypertension. What I can tell you is that the MCs monitoring regularly the study we completed, the recruitment. We are waiting. The