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Msg  6384 of 6705  at  3/3/2021 6:14:26 PM  by

teflon2000


Bristol-Myers Squibb Co. (BMY) Management Presents at Cowen Virtual 41st Annual Health Care Conference Call

 Transcript

Mar. 03, 2021 2:46 PM ETBristol-Myers Squibb Company (BMY), BMYMP

Bristol-Myers Squibb Co. (NYSE:BMY) Co

Bristol-Myers Squibb Co. (BMY) Management Presents at Cowen Virtual 41st Annual Health Care Conference Callwen Virtual 41st Annual Health Care Conference Call March 3, 2021 10:20 AM ET

Company Participants

Samit Hirawat - Executive Vice President and Chief Medical Officer

Conference Call Participants

Stephen Scala - Cowen and Company

Stephen Scala

Good morning and welcome to the Bristol-Myers Squibb session within the Cowen 41st Annual Health Care Conference. We're delighted to have Bristol with us again this year, representing the company is Samit Hirawat who is Executive Vice President and Chief Medical Officer.

There's so many new developments and new products and new initiatives at Bristol that -- it's a full-time job to keep track of them all. But the best person on the planet to give us an update on all of them is Samit.

So, Samit, thank you so much for spending this time with us.

Samit Hirawat

Thank you, Steve.

Question-and-Answer Session

Q - Stephen Scala

I'd like to start out by asking, Bristol has numerous -- has had numerous positive clinical trial readouts over the past year. What are the next clinical catalysts that you're looking forward to seeing over the next couple of years?

Samit Hirawat

Thanks, Steven. And certainly a pleasure to be here with you. And all the years I've had the pleasure of discussing many R&D related topics with you, and certainly very informative.

From a Bristol perspective, you're absolutely right, that 2020 was a year of a lot of positivity coming out of the pipeline. Looking at 2021 and a couple of years beyond that, as we've shared earlier in the year during our earnings call as well, the inflection points that are coming up.

So, if we take three categories of bringing in new medicines or new molecular entities, we had the approval of liso-cel already this year. We are looking forward to the approval in the near term for ide-cel. We've already filed in terms of the extension or new indications we've already filed Zeposia for ulcerative colitis and we'll see the approval hopefully, at the end of May. We've already shown the positive top line -- that we will be showing the positive top line for deucravacitinib later this year. So that is going to be into filing and hopefully available to patients next year for psoriasis.

But in addition to that, I think the next approvals coming for OPDIVO from the adjuvant indications perspective, lifecycle management of that product for additional readouts over the years. And then, of course, from the Factor XIa perspective, looking forward to the first readout of the first Phase 2 study in total knee replacement that will drive the future development process as well.

So, these are just a few of the infection points in 2021 and early 2022, but certainly are very healthy pipeline and looking forward to developing it and looking forward to more positives for the larger patient population with serious diseases.

Stephen Scala

Great. Let's spend a moment on deucravacitinib. So, when we get the full Phase 3, as you mentioned later this year, what would you suggest that investors focus on -- in Phase 2 deucravacitinib was about twice as effective in achieving PASI 75 as was OTEZLA, should that be the bar in Phase 2 or sometimes Phase 2 trials aren't quite as good. What -- how would you ask us to approach this data?

Samit Hirawat

Sure. And thanks for reminding everyone that there are two Phase 3 studies that have recently laid out. And we recently got confirmation. So, this is sort of breaking news in a way. We will have the ability to present both of these Phase 3 studies at AED [ph] in April. So, you will be able to see the full dataset, and certainly that will pave the way for our discussions with the authorities as we continue to get engaged in that side. We will not get into the specificity of the data. Now we are only six to eight weeks away, so you will get to see that yourself.

We do believe from our perspective, deucravacitinib will probably be the oral agent of choice because of the profile that we continue to see and as it is evolving with the data that we have. And the reason I say that is if you look at it from an efficacy perspective, not only is there the statistical significance that is required for the filings, et cetera.

But it is clinically meaningful improvement versus the currently used oral medication, which is OTEZLA and because of its mechanism of action through TYK2 specificity in terms of inhibition of IL-12/23, I think the safety profile will also define itself. So something to look at to pay attention to both from an efficacy perspective and safety perspective. And because of that specificity and where it is hitting in terms of the pathways, it opens up the space for looking at future indications as a broader medicine for autoimmune diseases of multiple indications, such as IBD SLE, et cetera, that will start to show data later in the year.

Stephen Scala

Why don't we spend a moment on some of those potential new indications? I think there were five or six that were mentioned at the R&D event you hosted in June. Can you kind of just maybe rank them the top two or three in terms of their potential and ability to really influence the trajectory on the molecule -- of the molecule? What are the ones that you think could really be a meaningful commercially?

Samit Hirawat

Absolutely. Being an R&D person, let me say that, first of all, from a mechanistic perspective, it is a differentiator in medicine that will have applicability probably to a larger extent in multiple autoimmune diseases. So, first of all, psoriasis we just talked about, but then we also have shared the data in psoriatic arthritis in the Phase 2 study. We are imminently starting the Phase 3 program in the psoriatic arthritis space, as you will see coming through.

You know that we have studies that are already ongoing in ulcerative colitis. And the Phase 2 study will have a readout at the end of this year, and that will pave the way for future development options for that disease.

We will have the Phase 2 readout for systemic lupus erythematosus as well at the end of the year or very early next year. So, looking forward to that, which will also then lead us into that indication. Study also ongoing in Crohn's disease and that data evolves in 2022. And so that will lead us to that indication in the future of data supportive.

And then there are multiple other indications that will continue to emerge and we'll pay attention to them as we build towards a larger program for deucravacitinib in the future.

Stephen Scala

I should have mentioned at the outset any investor on the line has a question. You can either email me or Mike, or you can submit it online and we will read your question to Samit.

Maybe we can move on and let me preface this by saying Sanofi was at our conference yesterday. And as you can imagine, they were citing some of the potential risks with agents, which were worked through the pathway that deucravacitinib works through. And they were basically arguing that there's a common pathway and all agents, whether they're regardless of their configuration within the JAK family are funneled through the same pathway. And therefore, there's this potential risk. Why is that not correct, Samit?

Samit Hirawat

So, I think scientifically speaking, and we've done multiple experiments, and we should certainly start to understand that not all pathways work in the same way and not all the molecules are JAK inhibitors. Certainly, we know what the concerns are around the JAK inhibitors.

When we think about deucravacitinib and the reason we continue to say that it's a TYK2 inhibitor is because we've done the medicine chemistry. Our scientists have really designed the molecule for that specificity to work through that pseudo kinase domain of TYK2 to have a very specific downstream effect on IL-12 inhibition, IL-23 inhibition and interferon health inhibition.

And what that leads us is into that profile from both efficacy perspective, which as you will see the data will continue to show how it lines up with those inhibitors of IL-12/23. And from a safety perspective that we are not seeing those signals of lab abnormalities. We are not seeing signals of those cardiovascular events or VTEs, that would be of concern.

So, we do believe from a preclinical perspective, from a clinical data perspective, it just informing our hypothesis. We feel very comfortable as we look forward to presenting these data and taking them to the authorities. Now, of course, what the authorities will decide based on the data will conform to that. But we do believe that the differentiation that we have brought together in the design of the molecule and the conduct of the trials and the data that we've been able to generate differentiates itself.

Stephen Scala

Okay. Great. One more question on this topic, and then we'll move on to other topics. So, Bristol has a follow on TYK2 in development. How is it differentiated from deucravacitinib?

Samit Hirawat

So, at the current time, it's in a very early Phase 1 -- early Phase 2 study. And primarily the way I think about it is that you always want to have a backup plan just in case the first one doesn't pan out, but I wouldn't really raise any alarm signals that -- one that we are going to accelerate that for some reason. It has to show its own activity. It has to show differentiated profile versus deucravacitinib. Now that we have the Phase 3 results already in hand, but nothing that we have today that we can talk about in terms of differentiation of that molecule.

Stephen Scala

Okay. Let's move to cardiology and then we'll move on to oncology where my colleague, Mike, also has some questions. On cardiology, so we're all very excited about your Factor XIa, is the Phase 2 total knee hip -- total knee replacement trial on track for readout in the second half of the year? I know, you had indicated, and it's very understandable that COVID might have an impact on that. So, what is the latest update on that trial?

Samit Hirawat

Sure. So, we are still very confident that we'll have the readout of the total knee replacement study in the middle of this year, in the second half of this year. And then, for the secondary stroke prevention study, which is very important, I think for overall definition of the molecule from both safety perspective, dose defining perspective, and an early indication of safety, because the secondary stroke prevention study really is looking at the background therapy of anti-platelet agents and how Factor XIa can be safely combined. And that study should readout in the early part of 2022.

The proximity of the two readouts does allow us the ability to not only build a clinical development plan and be putting it in front and center in terms of our excellence and execution of the Phase 3 when we are ready to do them. But looking forward to those two readouts and then defining the overall profile for the product and then taking it forward.

Stephen Scala

Okay. When you were answering about the total knee replacement, you mentioned midyear, and then you also said H2. So, can we assume it's going to be early in H2?

Samit Hirawat

Seemingly that way -- that's how I would look at it, but don't have the exact date yet.

Stephen Scala

Okay. And so this is another pathway, which with other molecules in past years, issues have arisen. So, how often are safety checks and are you comfortable with the safety profile so far?

Samit Hirawat

Well, there is a data safety monitoring board that is overseeing the Phase 3 or Phase 2 development program. These are randomized trials, very large randomized trials. So, there are periodic safety checks through the DSMB and no alarms have been raised thus far in terms of us having to intervene at any point.

So, we are comfortable with the emergence of the data. We, obviously, don't have the unblinded look at the data yet, so, keeping it kosher from that perspective.

Stephen Scala

Okay. And is there a head to head with Eliquis in the plan somewhere down the road or is that not a trial that would need to be done?

Samit Hirawat

Well, I think, it will depend on the -- on what the indications that we're going to pursue and what the indication that required Eliquis as a control arm. Those are elements that are going to have to be discussed not only within the company, within the sponsors of the study, but also with our partners, as well as with the regulatory agencies that what would be required if we were to pursue indications that currently are in the label for Eliquis as well. So, too early to comment on that, but certainly, something that we'd have to continue to debate.

Stephen Scala

Okay. And here as well, you have a backup. Is it similar to the TYK area where you just want to have a backup just in case, or is there anything differentiated about BMS 209?

Samit Hirawat

No. I think that the same principles that apply that you always want to have the backup plan. Because if you believe in the science, if you believe in the target, if you believe that that mechanism is important and you're going to take it forward, then you want to have a couple of opportunities in your hand so that you pick the best one to take forward. And we have no alarms that have been raised for the current incumbent and the front runner. So, again, working at the regular pace for the backup molecule.

Stephen Scala

Okay. Let me ask -- moving to oncology. Let me ask one question, then I'll send it to Mike. So, the first line renal space is ever evolving, rapidly changing and large opportunity. So, given the recent data, how do you size up the efficacy and safety profiles of the various regimens, including those that Bristol has?

Samit Hirawat

Sure. See, look, I think from a patient perspective and how physicians are treating patients with renal cell cancer in the first line, there are three major elements. One is, of course, IO/IO combination. Second is IO/TKI combination, and third is single agent TKI. When we look at what OPDIVO and OPDIVO/Yervoy have brought to the forefront. We had the first study that readout for OPDIVO/Yervoy and we saw the overall outcome, which now is -- now four years of follow-up that shows us that we still don't have a median for the duration of response. And so, for those patients with intermediate and high-risk renal cell cancer, I think it is important that it's a very, very critical element for the treatment option that physicians have for those patients.

With 9ER, what we have seen is the expansion of that in terms of having the low-risk patients also included now. So you have the ability to treat or use IO with TKI for treatment of patients with renal cell cancer.

I'm sure what you're alluding to now is the new emergence of the data from the clear study. Of course, we've seen that. And it's important to realize that you can't just put all eggs in one basket and say, they're all the same, because you have to start to see what the differentiation might be in terms of patient populations that have been enrolled in those studies versus the 9ER study. What's the emergency -- the safety profile. And very importantly, what is the follow-up time? And so having that four year follow-up for IO/IO, having more number of the intermediate high-risk and not just the low-risk patients included in the 9ER study and having a safety profile that is well understood for 9ER at this time and having probably one of the best TKI combinations, I think that put us in a place where we know it is a competitive space, but we are used to it in the renal cell space right from the beginning of the days. So, we feel very confident that our profile will certainly pass muster and physicians and patients will have the opportunity to use it to be extended if they should.

Stephen Scala

Mike, I'll turn it to you.

Unidentified Analyst

Great. Thanks, Steve. Let me -- I was wondering if you could talk a little bit about the CELMoDs in your portfolio. Maybe there are several, maybe you give us a lay of the landscape? How are they similar or different from marketed agents? How are they similar or different from each other? And how well-characterized are their targets? How are you positioning them indication?

Samit Hirawat

Sure. And thank you. Because it's a large question and not just specific to multiple myeloma, so I'm glad about that. So, CELMoD certainly from a platform perspective, a very promising way of looking at targeting and building drugs for targets that we're concerned to be non -- are undruggable, right?

So, from a CELMoDs perspective, which leads us into the protein homeostasis and protein degradation aspect of the platform becomes very important and we've begun to see the emergence of the data. When we think about [indiscernible] degraders, such as the first CELMoDs in multiple myeloma CC-220 and CC-480, that is telling us that our hypothesis is sitting well. We've seen the response rates two years ago for CC-220, with 30% plus response rate. And with 480, we've started to see the 50% plus response rate as this presented recently last year, actually 2020.

From the multiple myeloma perspective, the way we look at the two agents are, there is a higher potency for one, and therefore we do see a profile that has a little bit more neutropenia for 480, as opposed to iberdomide or 220. And we have the larger expansion arms now ongoing for both studies. First of them, the 220 will readout this year, 480 will readout next year. And depending on the magnitude of response -- duration of response, we will be able to then have conversations with regulatory authorities in multiple myeloma.

But beyond that, we have several other agents in development. There is a 282 -- CC282 in lymphoma that is being pursued as well in addition to the other -- the others that I talked about. We have new agents that are being also looked at in the leukemia space. So, I think, we are just at the beginning of the CELMoDs and beginning of discovery of these new molecules that are going to be protein degraders, and really a very promising area where we will be able to go through our library that we've been able to now build and bring new molecules for a multitude of diseases. And just as an extension of that protein degradation platform, we're also looking at LAG of a target. So, such as the first one, which is in the clinic is the androgen receptor degrader, and that is in the prostate cancer setting in the Phase 1 trial. So once that data evolves, we'll learn more.

Unidentified Analyst

Great. So you touched on this a moment ago, but could you give us a little more detail around filing timelines for iberdomide you mentioned phase -- early phase data in multiple myeloma at the end of the year. Is that sort of on an accelerated approval pathway in your mind? Or how do you actually think about filing?

Samit Hirawat

So for -- as I said earlier, for both of the studies, so CC-220, or iberdomide, we're looking at the readout of that fourth line plus population data within this year. And so, depending again, as I said, it depends on the magnitude of the results and the durability of those responses that we will hopefully see, will dictate as to how to approach and when to approach regulatory authorities, and what type of approval.

For 480, we are in -- we have just begun the expansion phase. So that readout will be next year. And depending again, on the similar attributes of response and durability and the patient population that will be enrolled in this study, will dictate as to the approach and how we go.

Very importantly, though, if you think about the overall multiple myeloma strategy, we have to not only think about CELMoDs, but the combinations of those CELMoDs with standard-of-care and future therapies. And so, this year we are also launching the Phase 3 program in the earliest setting for iberdomide that you will start to see, and that will pave the way for bringing these CELMoDs to an earlier line of treatment, because the ultimate game is to be able to compete versus IMiDs and at some point replace them.

Unidentified Analyst

Okay. You mentioned this as well while you touched upon the androgen receptor degrader, clearly the chemistry associated with CELMoDs and sort of lend itself to some opportunistic avenues that you could go down in terms of looking at other cancers, but also potentially other therapeutic areas. Is that an approach that Bristol is taking? Are you sort of screening your library periodically for targets that might be interesting, in say, immunology or neuroscience or others?

Samit Hirawat

Yes. So, as I said earlier, our understanding of our protein degradation continues to evolve and increase, but we do have several targets that have been identified, but we have not spoken about them publicly. So, I won't go deeper into that. But yes, the areas of our interests, we have several targets that we are continuing to build our molecules already for taking into the clinic. As I said earlier, we already got into lymphoma, we've gotten into multiple myeloma, solid tumors, and we'll continue to evolve. A very exciting field, I truly feel fortunate to be working in that field at this time.

Unidentified Analyst

Thanks. I'll turn it back to Steve.

Stephen Scala

Let's talk about some other exciting targets within your pipeline. Let's talk about maybe relatli …

Samit Hirawat

Relatlimab?

Stephen Scala

Yeah. And so, we're heading into an upcoming pivotal melanoma readout. Maybe you can kind of frame what our expectations should be for this readout?

Samit Hirawat

Sure. See, if you recall for LAG3, the strand started as a Phase 2, 3 study. So there was an interim look by the BMC to make sure that this trial can proceed from a Phase 2 and convert into a Phase 3 based on statistical principles. So, obviously, we crossed the significance boundaries, and that's why it transitioned into Phase 3, which is going to readout imminently. So, the specificity of the data will be available once we have the readout.

The idea around here is to be able to show superiority of the combination of relatlimab plus OPDIVO versus an active competitor OPDIVO itself. So, that superiority is going to be important. But more importantly, I think out of this trial, what we will see is also the emergence and outcome of the biomarker data, which will tell us how to proceed further.

What are the signals that we need to continue to chase and pursue for potentially additional indications or additional combinations thereof? Because I do believe, I think our philosophy will continue to evolve that newer IO agents are the newer checkpoint inhibitors and newer IO therapy is going to be applicable to all patients, or are we going to start to see a convergence into a precision medicine like mode where we have to preselect. So, I think that's what I'm looking for from relatlimab data will start to give us that signal of where we should really go and the specificity of that going forward.

Stephen Scala

Even more readouts are coming in the second half. Wempeg [ph], for instance, I think there are five pivotal trials that we reading out in the second half of this year. What is your level of confidence? Or how has your level of confidence changed on this in the last six months, maybe based on an interim look or other data? I mean, how are you feeling about these readouts?

Samit Hirawat

Steve, we've always spoken about that we'll continue to follow the data and the science that emerges, and therefore, our limitation in terms of how we want to evaluate the five tumor or five trials in the three indications, and renal cell of course, the melanoma and the bladder studies, just a minute correction that the first readout is anticipated in 2022, not in 2021. Some of that is COVID related and on so and so forth in terms of the overall impact on studies.

Having said that our intent is to certainly look at continuing to evolve from a superiority perspective, trying to demonstrate just starting with melanoma, but then also in renal cell, as well as in bladder, how that IL-2 combination or our perpetuation will evolve in terms of improving the outcomes for these patients. We, obviously, don't talk about interims and all that, because that's not the intent here, but certainly we were more comfortable with the data in these diseases when they were available from the early studies. And that's why we pursued these and not market studies.

Stephen Scala

Okay. Let's spend a moment on TIGIT. So, Bristol has a TIGIT, but it is not -- has not been advanced in pivotal trials that we know of. I think that in June, management said that you were determining whether the profile was unique or optimal in any way. Where does that process of evaluating this molecule stand?

Samit Hirawat

Yes. So, our TIGIT inhibitor is in Phase 1 study, defining the dose and the safety and the profile of the medicine to see if there are signals of activity that we can start to see. We are not yet ready to get into a later phase study or looking at combination data yet. We are, obviously, aware and have had discussions around where others are going like Roche or Merck and others, because those studies -- they were randomized studies. They generate the data.

As I said earlier, one has to keep on looking as to what are the elements that are going to be important in a TIGIT inhibitor. And then what populations are the ones that are showing the benefit of the combination of TIGIT with PD1 inhibitor. I think that's far and I'm guessing you would agree that the higher impact has been seen in those high PD1 expressing populations in non-small cell lung cancer. So, certainly, indication that, that others are following. We are behind in this one, and we have to now see where the data takes us as it evolves from our Phase 1 study. We are not there yet.

Stephen Scala

Okay. A couple other topics in our last few minutes, NASH. So, Bristol has a footprint in NASH. It doesn't get a lot of attention. FGF21, for instance, is a molecule in your pipeline. So what should we be thinking about Bristol's future in NASH?

Samit Hirawat

So, overall, fibrosis portfolio certainly is part of our pipeline. We have the FGF21 in NASH, two studies, FALCON 1 and FALCON 2 in F3 and F4 populations that are right now being conducted. We will see the data later this year, and that will define the path forward in terms of how the data evolves and how do we then follow the science. Should we be thinking of combinations, et cetera? But since these studies are again, blinded studies, we don't know ultimately what the data would tell us. And once that is available, we'll certainly talk more about it.

But certainly our overall fibrosis pipeline is composed not only of the NASH component, but also the fibrosis component with JAK 1 inhibitor, as well as LPA 1. So, pretty healthy from that perspective, but data will dictate ultimately where we end up and where we go and change it.

Stephen Scala

Okay. Another product, brand ibrutinib. So, Bristol has chosen immunology indications for the asset rather than what might be higher probability indications. Will it be tested in MS? If not, why not? What's the outlook for this molecule?

Samit Hirawat

So, I think, BTK inhibitors are pretty entrenched in the oncology space. You're very well aware of that from hem perspective and are broadly use. We have taken and chosen the path of utilizing a BTK inhibitor in a multi-pronged approach in autoimmune disease with rheumatoid arthritis, Sjogren's syndrome, SLE. Those are the patients being enrolled in our ongoing study.

At the current time, we don't have any plan to investigate it in MS. At this time, our focus is on Zeposia launch and we'll continue to evolve there. And then if the data can use the emergent dictate that we have to change our path to think different, we will. But at the current time, we would like to see the data as it emergence from the autoimmune diseases.

Stephen Scala

So, we're down to only one minute left. So, we talked about some of the -- more visible promising assets in late phase development. But Bristol has a deep -- early and mid stage pipeline. So what are one, two or three molecules that we haven't talked about, that maybe you haven't talked about in the past to investors that you look at and say, gosh, this could be big.

Samit Hirawat

We touched on a few. So, maybe I will pick one from all different phases. So, certainly, we've talked about it. But in our view, it is a new entrance to the BMS pipeline, which is mavacamten, which we do believe is a very effective drug that we will hopefully get the submission and then approval for that drug for patients with obstructive hypertrophic cardiomyopathy, but nothing really exists today that targets the underlying cause of the disease. And then growing on that will be additional indications of the future. So that's something very, very important.

Another one would be Reblozyl that we talk about, but we haven’t talked today. But certainly the next evolution of the data and from the COMMANDS study, as well as from the independent study in MDS and in myelofibrosis, respectively will really be very important from the future growth perspective.

We already touched on the protein homeostasis platform in the early phase. I won't belabor that again, but certainly in oncology, we do have a TGF-beta inhibitor. We do have IL-12 that we continue to also keep an eye on as the data will continue to evolve and how we can do the full combination thereof.

In the cell therapy space, we didn't touch much today in this discussion, but certainly ide-cel and liso-cel being the front runners, but how those will evolve from a combination perspective, or whether it be in multiple myeloma or lymphoma, the next readouts that will be coming out in the early settings of lymphoma for liso-cel will certainly be triggering another infection point for that particular therapy.

So, there are -- some of these elements that are critical to think of in addition to what we talked about already.

Stephen Scala

Great. We are at a time. So, Samit, I want to thank you for a great and thorough rundown, and we'll continue to watch the many positive and exciting things underway in the Bristol pipeline as the years unfold. So, thanks so much for your time today.

Samit Hirawat

Thank you, Steve and Mike. It's always a pleasure as always very informative for me as well.

Stephen Scala

Thank you.


 


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