Bristol-Myers Squibb Company (BMY) Earnings Call Transcript & Summary

This is Navin Jacob, welcome to the UBS Global Healthcare Conference. Our next session is with Bristol-Myers Squibb. As I said, my name is Navin Jacob. I cover large-cap pharma and Biotech. Thanks for being with us. And from Bristol, we have Samit Hirawat, EVP and Chief Medical Officer; as well as David Elkins, EVP and Chief Financial Officer. Thank you, gentlemen, for joining us today.

Great, Navin.

So what we're going to do this afternoon is have a fireside session with the folks from Bristol, which will be driven by me. But folks online, you are able to actually ask questions over the internet. At the bottom of your screen, you should be able to submit those questions. They will be anonymous, and I will try and read out as many questions as I can towards the end of our 45-minute session here.

Maybe, David, we can start with you, just given that during Q1, a lot of -- yourself and your peers were seeing still some residual lag from the pandemic, particularly to certain therapeutic areas. A number of oncology and hematology products came in a little bit lighter. How is the trajectory for Opdivo and other heme products, specifically as it relates to sort of foot traffic associated with the pandemic, both the U.S. and international? Are you seeing things getting back to pre-pandemic levels?

Yes. Thanks for the question. And we, as well as some of our peers saw an impacting with the resurgence of COVID. But also, as you know, there's some significant weather that hit the Midwestern part of the United States as well, which, we think, probably added to that. We saw new patient volumes were down across oncology and hematology as well. So the market is still disproportionately off limits to in-person medical and commercial interaction. But so far, the business, overall, has remained pretty resilient through that, and we reaffirmed our guidance based upon what we were seeing in the business. And we anticipate, in the second half of the year, returning more to normal. And we've been encouraged by what we're seeing out in the field with vaccination rates going up. And in some other parts of the business, like our cardiovascular and immunology parts of the business, starting to get access into seeing physicians. So we're encouraged by what we're seeing and anticipate that it will be more back to normal as far as interactions in the second half of the year.

And then a little bit longer-term as far as Opdivo is concerned over the course of the next 1 to 2 years. How do we think about growth drivers, especially as you see some competitors coming into the marketplace, such as Lilly or Chinese manufacturers or Regeneron that could affect pricing in the PD-1 space?

Yes. Again, look, we feel really good about Opdivo's trajectory over the next couple of years, and our return to growth. We've had several clinical and regulatory successes over the last year, and that gives us confidence about our ability to grow the second half of this year as we go into next year. And a couple of things. We're pleased with how first-line lung launch has been going and the recent launches of nivo plus CABO in first-line RCC with our 9ER study. With first approval, I-O agent in first-line gastric as well. And adjuvant and esophageal. All those things make us feel -- give us confidence in the ability to grow. We also expect our first approval in adjuvant, a muscle-invasive bladder cancer as well with the PDUFA date in September of this year, and we expect to submit a review our positive clinical trial data on CheckMate-648, which could round out a presence across the upper GI cancer areas across histology as well as tumor locations. So I feel really good just about all the data we're having approvals this year. And outside of these, over the next few years, we have additional trials in early-stage lung, such as our Checkmate 73L and Stage 3 unresectable lung cancer. And so plenty of other neoadjuvant and preadjuvant studies that we're anticipating getting those clinical readouts, and Samit can talk more about those. But we have a lot to look forward in the I-O portfolio. Thoughts on price competition, the second part of your question, as we think about the number of PD-1 entrants in the marketplace, we really look at it from 2 dimensions. There's competitive impact of having additional players in the marketplace, but we've been able to navigate competition well, and we think we're well placed with the relationships that we have with stations, but as well as the strength of our sales and marketing organization. And we believe 2 things really have to happen for commoditization of the market. First, someone needs to come in with a low-cost entrant. And the second, there needs to be a perceived interchangeability by physicians and payers. And given this is very much a market as we're just talking about based upon data and having the clinical studies to support the program, we think that's the most important thing and what we'll remain focused on and ensuring that patients are treated with products that have the clinical data to support the efficacy and safety profile that we have. So we remain confident in our ability to grow over the next couple of years.

Got it. And then Samit, you have an upcoming ASCO event. And one of the key showcases there will be relatlimab and the anti LAG-3. You're going to be showcasing PFS data there? I think the folks are waiting also to see the OS benefit. It is still a little immature the data to showcase that. But how do we get comfort, I suppose, that the PFS benefit that you've shown will translate to an OS benefit? And then how are you thinking about the overall profile of relatlimab, and where that will play in the melanoma space, which, obviously, you've done very well with Opdivo and Yervoy? Just wondering how we think about positioning of the asset as well?

Yes. I mean, thanks for that question. We are very, obviously, pleased with the progress on our overall I-O franchise. And this is the third I-O therapy within the BMS portfolio beyond, of course, nivolumab and then Yervoy and now comes relatlimab, which is added on top of a very active single-agent therapy melanoma. And as has been published and shown now to the abstract and the data will be presented, we are showing a doubling of the PFS in this population, where certainly, as you said, we've done really well with Opdivo plus Yervoy. But still, if you think about more than 60% of the patients still not getting the doublet therapy. So that's where, I think, the real benefit really lies over the doublet combination of Opdivo plus Yervoy versus when we're looking at the newcomer Opdivo plus relatlimab. So it's about optionality, not necessarily competing versus that previously established doublet. Because still today, 1/3 of the patients are being treated with single-agent PD-1 and 1/3 of the patients are not getting I-O based regimen. So that's where there is a need to continue to evolve in terms of providing benefit for these patients with melanoma will be. True, that we will be showcasing the PFS, will be showing the overall safety profile of the combination, which we're quite pleased about in terms of the manageability of it. I think it is very important to continue to follow these patients and evolve from an overall survival data perspective where we are currently blinded on as well as the response rate that we are currently blinded on. But we've seen in the past that for I-O agents is a longer-term follow-up that really starts to separate the tail of the curve. And starts to show the results. So we have to just wait. It's an event-driven endpoint. So we have to wait and watch on that one. And as that data becomes available, we, of course, certainly be very happy to share that information as well. I think strategically, it's very important to understand that this is approach that fits very well with our portfolio, especially in the co-formulated first fixed dose combination of Opdivo plus relatlimab that we're going to be bringing out now to this study.

And what are patients in the Opdivo model arm? What are they allowed to -- are they allowed to crossover to the anti LAG? Or can they move on to a doublet I-O of Opdi Yervoy? Or what are they allowed to do? Just wondering what the potential impact could be to the OS curve.

So because the overall survival is our key endpoint within the trial, crossover within the trial is not allowed. So patients who are on nivolumab arm cannot go into receive nivo plus relatlimab. But certainly, as you very well pointed out, they can go on to receive other doublets in the second line, et cetera, as far the clinical practice or what their physician decides. We cannot limit that. We cannot mandate that because it's clinical practice. But relatlimab will be protected from that perspective. We'll see what the data, ultimately, will roll out of changeover. But we have methodologies in place in terms of doing the analysis of looking at up to the time when the event occurs a progression-free and then from there onwards growth survival as well based on adjusting for the crossovers to I-O therapies in the future.

Got it. And then we do actually have a question from the audience as it relates to the relatlimab program. Beyond first-line melanoma, what other indications do you see fitting well for anti-LAG-3, whether it's lung cancer -- non-small cell lung cancer or other indications? And just -- I guess I'll just kind of add to that. When you think about anti-LAG-3 as a mechanism, where do you see that fitting the best from an indication standpoint?

So certainly, this is just the beginning for relatlimab, and we are seeing the first data in the first-line melanoma patient population, but the natural progression from here, of course, would be to look into the adjuvant setting, and you'll see that study going up very soon in progressing the combination of nivo plus VALOR in the adjuvant setting for melanoma patients. We currently have the Phase II program that is already ongoing. The first one in non-small cell lung cancer looking at nivo and chemo versus nivo/chemo, it's a Phase II study, which will set us up for not only looking at the doses, but also in terms of looking at initial safety, efficacy in combination and sets us up for the Phase III program starting late this year, early next year. And then, of course, looking at hepatocellular carcinoma to generate that proof-of-concept from a Phase II study that we can then take forward into the Phase III program, again, looking to the next year. Beyond that, we continue to evaluate where else the applicability would be best. We will continue to follow the science. We'll continue to follow the data from preclinical as well as external data perspective, and that will then lead us to the additional indications in the future.

Got it. And then sticking within the I-O theme, at one point, you were talking about developing a subcutaneous PD-1. Merck has kind of showcased some early data with theirs. Can you remind us where you are in development with your subcu PD-1?

So we have just actually initiated the Phase III program for the subcutaneous nivo or PD-1 inhibitor. It is a noninferiority study. We are evaluating that in the patient population that has been previously treated, that is renal cell carcinoma patient population. The Checkmate-60-70 is the number for that. It's on ClinicalTrials.gov. It is just the reading now. So we are looking forward to read out of the data, and that will set us up for the registration and bringing it to the patients.

And so what's the registration of that then, Samit? Is it -- if you read out on that, can you get and -- you show -- do you have to show by equivalence? What are the metrics that you're looking at? Do you have to show clinical endpoints, hard clinical endpoints? And if so -- and if it is -- does work, it looks the exact same as intravenous, can you get broad approval across all the indications that IV Opdivo is approved for?

Yes. So the general intent usually in these studies is to show the bioequivalence, and those are the primary endpoints related to this overall clinical pharmacology parameters that you have to define, and that's what the intent is. We'll have to collect the hard data points as well as from an efficacy and safety perspective. That will become support of doing the discussions with the health authorities. But in general, the primary endpoint is the clinical pharmacology part of it in showing the noninferiority compared to those parameters and then bringing it forward. In general, the application would then apply to all indications, but those are, again, going to be a points of discussion, as we go forward with the health authorities. If there are carve-outs that we don't know.

And what would an ideal path forward be here for subcutaneous? Do you co-formulate it with other novel products and/or would you use it and sell it as an individual PD-1 by itself?

So it's a little bit early to be really commenting on that yet. We do know that this is a recombinant human hyaluronidase PH-20, right? So it's it's got that in terms of the formulation of it. And you know that we have backup CTLA programs that are currently running. We have the co-formulated of our fixed-dose combination of VALOR and nivo at this time that we talked about earlier. So the possibilities are numerous. But it's a little early to talk about fixed-dose combinations in the subcutaneous formulation. So those are thoughts that will start to -- we'll start to pursue in the coming time, but nothing that is prime time at this time.

Got it. And then I saw you recently entered into a collaboration for anti-TIGIT. Curious about that product, it's a bispecific. Or what's the other -- I think you had a chance to dig into that. But what's the other target on that antibody and what tumor types are you looking at for anti-TIGIT?

So from the other target on that bispecific, we are obviously not disclosing that right now due to competitive reasons, but certainly very, very excited to have that in our overall pipeline. It's of high interest, of course, with emerging clinical evidence that TIGIT, as a target, is important, but having a bispecific provides us with a probably differentiated option for development in this particular exciting space. As you know, our internalTIGIT as an inner Fc domain, right? And this one comes with the augmented, very active Fc domain. So signs is not clear yet whether that is required or not. But certainly, it gives us both ways of dealing with a TIGIT target as well as being a bispecific trying to address other pathways that are open by combining it as well as looking at a single-agent activity. In terms of pursuing indications, the obvious one, based on what data has been shown and generated this far, is going to be non-small cell lung cancer, but that doesn't mean that we will close the doors on the others, and we'll have to just continue to look at where the science leads from a preclinical as well as the clinical perspective as we go into the clinical realm. As you know, the IND is yet to be filed. And as we file the IND start the Phase I, which could encompass a much broader tumor type, and then from there on, signal generation and then leads to the next-generation of indications that we will pursue.

Got it. And then maybe back to David. So Revlimid, typically -- we'll be starting to see some generic center in '22, '23. Typically, when we think about small molecule cliff, 80% of sales are lost in year 1. But obviously, you have volume-based agreements in place with the generic manufacturers. So I think there's still some lack of clarity as to how this erosion curve might play out? How should we be thinking about that curve? Is it like a complex generic curve, a biosimilar curve? Not there are that many analogs for either of those, but any kind of color for how we should be thinking about this would be helpful?

Yes. And thanks for the question. I think as it relates to this, I mean, as we've been saying all along, that it's more of a slope than a cliff, given the generic settlements we have. It's really difficult for us to precisely give you an erosion curve because many of the settlements are confidential, and because we're still under active litigation with other generics. But what I can say is that we do view this as a slope, given the settlements that we have. And for those agreements that have been disclosed, U.S. entry comes next year with one party in March, and that will be in the single-digit range and grow for each consecutive year after that. And for the subsequent settlers, they can launch someday after March 22. But all in all, what we try to do, we provided medium-term outlook, which accounts for our LOEs that we have through 2025. And estimate that 90% of our business, by 2025, will be from our in-line products and new launches, excluding Revlimid and Pomalyst. So we expect revenue CAGR in the low to mid-single digits between now and 2025. And so more than offsetting both the confidence we have in Eliquis' continued growth, Opdivo's continued growth with all the tumor types I mentioned earlier, but as well with all the launches that we have. We got both cell therapies out there now, ZEPOSIA as you see launch coming. We're really pleased with no Reblozyl is going. And as you know, we also have the mavacamten PDUFA date coming up. So we have a lot of products. I didn't even mention all of them, but give us confidence in our ability to have a CAGR that's going through 2025 despite the Revlimid LOE.

Got it. And then with regards to capital allocation, you've highlighted business development is an important part of your strategy. In fact, I think you recently noted it as a #1 priority. You did a very interesting deal with MyoKardia -- for MyoKardia. What type of assets are you looking for, both from a stage development standpoint and a therapeutic area standpoint?

Yes. So we -- correct, sourcing innovation externally is critically important to our strategy. We have a broad set of capabilities and skills that we can apply through our key therapeutic areas, and that's where we're focused, solid tumor oncology, hematology, immunology and cardiovascular, as you rightly pointed out, with the mavacamten deal that we did late last year. Most of the opportunities we see are in the early space, like the Agenus 1 that we recently announced. But we look at deals of all sizes, and we'd love to get more deals like the mavacamten deal, which are broadly derisked and we can plug them right into our existing infrastructure and capabilities to get the products launched as quickly as possible globally. And that will further contribute to our growth into the second half of the decade. Now I think you're asking about -- the second part of your question was -- just if you could repeat the second part of your question?

Just on development in therapeutic areas?

Yes. So I think I answered most of those. It will be a mix of -- you'll probably see more of the early, but we're hopeful that some more of those -- there's later stage ones will get -- that would have a similar profile to mavacamten.

And then with regards to what you're deciding on choosing between dividend or share repo, you've reintroduced your share repo. And -- but you've also been growing your dividend. And so how do you think about what's more important there? And do you have -- do you set a target -- do you have sort of a target payout ratio in mind for the next few years?

No, we don't have a specific payout ratio in mind. But look, we've been very consistent in our capital allocation approach and strategy and returning capital to shareholders is critically important. And I think we've demonstrated that with our -- from a dividend perspective, the 12 years that we've increased our dividend. And that we know that's important to shareholders, and we'd love to continue to grow the dividend. But also, at the same time, as you know, deals come, you're constantly looking. But if we have cash, we're opportunistic about returning that to our shareholders. We're not looking to continue to build up cash balances. I think we've demonstrated, this year, being very prudent with our cash, paying down the debt. We did a further $4 billion of debt buyback, which just further strengthens the balance sheet and gives us more strategic flexibility in the future. But as well as on the share repurchases side, we took some of our cash and increased the share repurchases to $3 billion to $4 billion this year. We did about $1.5 billion last year, and if you remember, when we closed the Celgene transaction, we did an ASR at 7 -- $7 billion. So dividend is important. We're looking to continue to grow that. We're opportunistic on the share repurchase side. And -- but our #1 priority remains replenishing the portfolio and bringing in assets that help us grow into the second half of the decade.

There are several companies of your size that are looking to do deals. And the equity markets have been pretty favorable over the last few years to the biotech industry. So to that extent, does that make deals more challenging if there's that much competition either from equity markets or from other -- some of your larger competitors looking to do deals? What's your confidence in the ability to get deals done in this environment?

We remain very confident in being able to get deals in this environment. I think we've demonstrated that. We look to be a partner of choice. We're very flexible on deal structures based upon what the other company is looking for. I think we're very attractive as a buyer in that the value that the asset -- many of these assets have since they're in our therapeutic spaces. We can bring value right away, increase probability of success from the development in the regulatory side of things, but also have the commercial infrastructure to be very competitive in the marketplace and create value beyond the value that's in the current holders' hands. So we remain very optimistic. We're very active today. We're open for business, and we're continuing to foster relationships so that when material events happen, derisking events, like on MyoKardia, that we're able to move very quickly on those types of deals because we've educated ourselves on the assets that we're interested in. So a lot of this is just timing and waiting for the right opportunity.

Got it. Back to Samit on some of your pipeline assets. So Samit, in hematology and multiple myeloma specifically, there is increasing investor interest in CELMoD. You also have BCMA T-cell engager and CAR T. How should we be thinking about your strategy in multiple myeloma at a steady state assuming that all of these are successful in some degree or the other, where do -- or all these -- products positions for what population? Is there some cannibalization that may be occurring or maybe not between these products?

No. Thanks, again, Navin. I mean, the reality is in multiple myeloma, despite the advances we made. The disease remains incurable. And we've been certainly on a pursuit to find better drugs, which will have a larger transformative impact on the disease itself. And certainly, we've contributed our part through image thus far. But now our focus on the strategy over the coming years is based on 3 major pillars. Number 1, as you said, BCMA-directed therapies, and we are very happy with the data that we saw with our T-cell -- our CAR T cell Abecma, where we -- which is now accrued in the U.S. for fourth-line plus relapsed refractory multiple myeloma showing very high response rates as well as the CR rates that we've seen with durability there. The second and third run of that ladder of the BCMA is the T-cell engager, where we are now investigating a subcutaneous formulation to see if we can continue to see high efficacy, but minimizing the toxicity. And the third one is the ADC, which is still very early in the Phase I. The second part of the pillar is the CELMoD. There we have the opportunity to really see the future as replacement of the image thorough this new class of molecules which are the protein degraders. And two of those opportunities, hybrid amide and CC-480, could be a short-term new advances in bringing these medicines to late line, fourth-line-plus stations with multiple myeloma with the relapsed refractory disease. Then the third one, which is the most important pillar is the combinations thereof. And you'll start to see already this year, CELMoD combination going into the Phase III trial in 1 to 2 prior lines of treatment with iberdomide, standard of care versus standard of care combination. Then we will start to see, in the next year and the years after, combinations thereof of CAR T cell therapy with CELMoDs as well as other CELMoD therapy combinations. So overall strategy, we know that curing multiple myeloma will require a multipronged combination regimen as we look forward. And that's where the focus will be, that to be able to take the 2 CELMoDs to replace the 2 immense, and then continue to build on the efficacy with combinations with T-cell engager as well with the CAR T therapy.

And then a notable area that, from what I'm aware of at least within hematology that you're not involved and please correct me if I'm wrong, is CLL. A couple of other -- your competitors have gone into the space. Now it is also -- I'm just wondering, is that because it's -- you view that market as a little too competitive? It is a little bit crowded? Or just curious as to whether you're going after that space or purposely not going after that space?

Well, I guess we need to do a better job of communicating it because we are in CLL. In fact, we have a -- our Breyanzi study that is ongoing in third-line-plus CLL patients population, and that should read out at the end of this year, and we will be able to share that data. We also presented some earlier data of single-agent Breyanzi as well as the ibrutinib combination at ASH or AACR. And showing really good outcomes or early response rates in these heavily pretreated patients. So we are really looking forward to sharing that. And as soon as that's available, we will continue to evolve. And then, of course, we have more strategies in development to bring treatments further up in line. Beyond CLL, we, of course, just to plug that in, in terms of the CELMoD platform or the protein degradation platform, hematology pipeline is very rich, actually. We do have early molecules in development for lymphoma. If we think about CC-282, starting to generate data that will be very important in the future. We have 90,009, looking at AML as, again, a protein degrader. We have a SIRP alpha, as you also mentioned, looking into AML as well. So the overall breadth of our hematology pipeline is quite wide and really promising, and we will continue to generate that data and share that in the coming years.

Got it. And then your TYK2 deucravacitinib, you showed very interesting strong data in psoriasis as an oral. We're also developing it for GI. On the one hand, you guys are lot less penetrated there, but there are oral assets there that look quite potent to JAKs and S1Ps. You have your own ZEPOSIA. What's your home for to -- in ulcerative colitis and Crohn's disease?

So absolutely, you're right. We are quite pleased with the data that we've seen thus far for deucrava in the Phase III trials for psoriasis. Of course, the supportive data are also in psoriatic arthritis, where we're just beginning the Phase III program as well. And the goal for -- and ZEPOSIA, of course, then brings in the first data for IBD towards the end of this year, looking at early -- or the first readout of -- for ulcerative colitis for deucrava as well. So the goal of any asset in development for ulcerative colitis or for Crohn's disease is really to provide meaningful improvement, not only in patient's symptoms, but also slowing down their disease and the endoscopic improvement in the clinical remissions as well. And as IL-12/IL-23 integrin alpha inhibitor read away, how -- they've shown, generally, if you look at IL-12/IL-23 inhibitors, they've shown good activity in IBD. So we are very hopeful that we can continue to further that science and show that an oral agent can bring in efficacy that could look like a biologic or close to that. So in terms of thinking of the future, with the readout coming now for the first readout that is coming now at the end of this year for ulcerative colitis with deucrava, we will start to think about when to initiate the Phase III program based on the data. The distinction between the time when ZEPOSIA will be available, which is, by the end of this month, we will have the PDUFA date in the U.S. and in the future and the other geographies. The time from ZEPOSIA to ulcerative colitis is at least -- to deucrava is a few years. So we have time over there. The second part is, unfortunately, these patients will cycle through multiple treatments. And physicians and patients are looking for new mechanisms of actions to really be able to continue the remission process for this disease. So in the coming years, when deucrava -- if deucrava is supportive, and deucrava is available for that indication, I think it will be an opportune time to continue to grow that GI franchise as well as bring relief to patients that a new mechanism of action, which has activity in business.

And then you're also pursuing the deucrava in lupus, which is an interesting completely underdeveloped space. Obviously, there's been very limited that's worked in that space. And what is it that you've seen, thus far, preclinically that makes you interested in pursuing your TYK2 pathway in lupus? And can you remind us of your timing of readouts in lupus?

So sure. As I was saying earlier, deucrava has a 3-pronged downstream effect based on the inhibition of TYK2, which is IL-12/IL-23, and most importantly, for SLE perspective or a lupus perspective, is a Type 1 interferons inhibition. So preclinically, we know that Type 1 interferon plays an important role in the overall pathophysiology of lupus in lupus SLE. And we also know that, in clinical studies, Type 1 interferon and IL-12/23 blockers have shown promising data. So based on that, we are hopeful that we'll see activity of deucrava in SLE. We have 2 studies ongoing, one on SLE, one in lupus. The readout -- our first readout in SLE is at the end of this year, very early 2022. And lupus nephritis will take time for enrollment. That would be in 2023.

Got it. Perfect. And maybe back to David. David, you have quite a few assets that you're launching, currently. And hopefully, there's some more in the future. You're also investing in a lot of assets on the R&D side of things. Just maybe, first, with SG&A. Over the next 2 to 3 years, how should we be thinking about that line growing? Is it at -- is it close to sales growth rate? Is it more along the line of low single digits like inflation? Maybe we'll start there and then talk about R&D.

Yes, great. So I'll just talk about our OpEx spending overall, and it's a great question. Particularly, as it relates to this year and last year, it's -- if you look at our expenses last year with COVID, it was really -- it was a really unique year in that, at the first part of the year with COVID and things shutting down in March, Q1, Q2 and even Q3 was very light on the expense side. And then as things started to normalize, we were able to do more investments in the fourth quarter, and that was very unusual. What we had guided this year is MS&A growing in that low- to mid-single-digits this year and as well as the R&D spend as the clinical studies come back up and as the things open back up again that was going to grow in the mid-single-digits this year. And as far as the phasing of that, it's about almost 50% in the first half of the year, pretty evenly split, maybe slightly more in the second half of the year, which is typical for what our phasing is in a non-COVID environment. I'd say the other thing I'd point to as well is, we don't guide individual line items. We'll provide more insight to that towards the end of the year when we normally do. But look, we're continuing to invest behind the business. We have a lot of flexibility in allocating resources from older brands into the new launch brands. We have a record number of 8 brands that we're launching between this year and next year. And we have the ability to move resources around to support those. So -- and just as a reminder, when we did our longer-term guidance, earlier this year at JPMorgan, we gave the indication that we anticipate our operating margins to stay in that low 40% range through 2025. So we've got a lot of flexibility. We're investing to win. We're investing behind the launch products, and ensuring we're doing everything we can to address the portfolio. And we're really looking forward to the product launches that we have ongoing, and so -- as well as the ones that are coming next year.

I don't know what this JPMorgan is next year may be, you can give you a long-term guidance of the UBS Global Healthcare Conference. But just on -- maybe back to Samit quickly on -- before we run out of time. I do want to touch on your Factor XIa, the first of those Phase IIs reads out midyear. How are you defining success and that would get you excited about the Phase III? Is the go, no-go decision based on just this 1 Phase II trial? Or do you need to see both Phase II readouts before you move to Phase III?

Yes. We are certainly looking forward to it as well, Navin, honestly. Because this is certainly going to continue to increase our presence in the cardiovascular franchise. So what we're looking for is a profile for the Factor XIa inhibitor that could be similar in efficacy to the factor Xa with a better bleeding risk profile, which can open up, of course, future opportunities, not only as a single-agent, but as we think about combining with a background therapy of dual anti-platelet therapies. As you know, we and our partners with Janssen, we're running 2 studies. The first study that you talked about that will read out is the monotherapy totally replacement study, which is being run by Janssen. And that's where we will start to see the dose response from an efficacy perspective and, of course, a bleeding risk. But remember, this is only a 14-day dose. Second study that we are conducting is a secondary stroke prevention study, and that is looking at the combination of Factor XIa with dual anti-platelet background therapy compared to just a dual background platelet therapy. And that is 3-month dosing. The collective viewpoint will be very important to really gauge the -- not only the dose, not only the safety, not only the efficacy, but the long-term or longer-term delivery of Factor XIa. So that's why the collective nature and the complementarity of each trial for the other is very critical for the overall clinical development plan to be really executed. As you can imagine, the single-agent data will support the single-agent queues and indications where we'll go with single agent. But the increasing use of anti-platelet therapy as a background for some of the indications will also be important, and that's why the second study becomes important. So as data becomes available, as they are shareable, we will, and that will then generate the additional dialogue around what the indications we will pursue with our partnership with Janssen.

Got it. And you somewhat answered this question, the question I was about to ask, which is around other indications and submarkets. You're saying it will be dependent on how these read out. But what are certainly some of the aspirations that you have with Factor XIa, what are those submarkets and indications? Just so we have a sense -- understanding it's still somewhat early stage of what the potential could be?

So we have not actually publicly talked about the specific indications here. So I will reserve that because we need to align with our partners before we start to convey that. And then that is synthesized and finalized, we'll certainly share. But one can imagine, we are conducting a study in secondary stroke prevention. So we're looking at the background therapy of anti-platelet agents. And so those will certainly be in the back of our minds as we look at the data and decipher what the next indications to follow in the Phase III trials would be. Both companies have a very strong footprint in the cardiovascular space. So we will be able to execute. We're very confident of that, and we'll be able to come to a very good alignment around the indications to be pursued.

The mavacamten PDUFA, as you said, is this year. And so how should we be thinking about the label expectations for that product? And then maybe a question, I don't know if it's fair, I realize it's hard to talk about pricing before you see the drug. But David, to any extent, you're able to share how we can think about pricing for mavacamten or any analogs that you guys were looking at would be helpful.

Maybe I can start off with the PDUFA date, it was January of next year, 2022. And we are continuing to work with the regulators in terms of moving that file forward as soon as -- as much as possible. And as soon as the review can be completed, we obviously can't get into the specifics of how the label will look like and what the attributes will be in there. But certainly, first of all, very excited about the data in itself that we have showcased early on, but the recent cardiology conference also showcasing the evolution from the additional data and the disease-modifying aspects of mavacamten are very exciting, and we continue to look forward to additional data sharing of new trials that are ongoing and the VALOR trial that is a randomized trial versus the surgical intervention as that continues to enroll. So those are all data that will come to bear towards the end of the year in exchange. But David, anything on the pricing side?

No, it's really too soon to say anything about pricing at this point. I mean, we're really excited about the product. There's a huge unmet need in obstructive HCM. The patients really don't have too many other treatment options here and other than eventually progressing the surgery. So we need to wait and see the final label, engaging with the HMOs and payers determine the appropriate pricing of the product, and it's just too soon from a competitive perspective to say anything about the price.

And then maybe in the final minute here. Samit, you mentioned the adjuvant lung trial for Opdivo. How do we think about that opportunity because many non-small cell lung patients present as mets patients on a relevant basis. Is the adjuvant opportunity, 1x the size of the mets non-small cell opportunity? Or is it half or twice as much? Any kind of color would be helpful.

I would not want to comment on the size of the opportunity. But I think, from a medical and clinical perspective, it's a very important element that we're going to try and answer. And that's why, as David had alluded to earlier, we've covered the whole gamut, the neoadjuvant, the adjuvant and the peri-adjuvant as well as an unresectable population where we are continuing to enroll in the 73L study. It is true that even despite unresectable in the early stages, at the current time, chemotherapy is not alone enough to control the disease, and 80% of the patients will have a recurrence of disease, especially the 2B, 3A population. So it is important to continue to develop these therapies. And of course, the data that has evolved with the PD-L1 inhibitors and others that will come through will be important to continue to look at it. We've ourselves shared the data from the neoadjuvant trial in the pathologic complete response rate, which are very interesting, very important which will contribute to their overall development with science and the data pool as we continue to evaluate the disease-free survival endpoint of that trial. And as we look to the readout of the adjuvant, peri-adjuvant trials as well. So I think totality of the program that we have, as David said, will contribute to the overall Opdivo growth strategy. We've got about 20-plus indications already approved in the U.S., for example. And we are now adding, on top of that, every few months, we have an approval. And so we're very fortunate that the studies that we have planned. The teams have planned early on are being to readout and very happy that we are in a place of now beginning to see the impact on the upper GI malignancies, renal cell cancer or the doublets and then more to read out in the coming years, not only lung, but gastric and renal and other types of cancers.

Perfect. And with that, we are at the end of our session. I want to sincerely thank Samit Hirawat; and David Elkins from Bristol-Myers Squibb, for joining us today. Thank you so much, folks.

Thank you very Navin.

Have a nice day, Navin.