Good morning. Welcome to day three of the Barclays Global Healthcare Conference. I am pleased to welcome Bristol Myers Squibb to the stage. My name's Carter Gould. I cover U.S. biopharma here. I'm pleased to welcome Lynelle Hoch, President of Cell Therapy Organization for Bristol, as well as Wendy Short Bartie, who runs the hematology and oncology business. Welcome both. Thank you very much for joining us today. Thank you, Carter. All right. Great. So, obviously we've got a big day tomorrow, a big day today in terms of Breyanzi approval, but a big day tomorrow in terms of Abecma ODAC. Briefing documents came out yesterday. Maybe Lynelle, just start with sort of, you know, your takeaways from the documents, anything that surprised you, and maybe your level of confidence at this point. Yeah. So, as you said, it is a it's a big day, and a week for Bristol Myers Squibb overall, and certainly in cell therapy. So starting with your question specifically around the ODAC, yes, we've had the opportunity to obviously review our briefing book and also on the competitor's briefing book. And I have to say, as we felt going into this week and where we sit today, we're extremely confident in the discussion that we will have with the FDA. We've been looking forward to this discussion, as if you remember, our action date was in December. So we've been anxiously awaiting the opportunity to defend our data and have a good discussion, particularly about the question they have around OS. But just as a reminder, we have already successfully had approval for KarMMa-3 in Japan. We successfully navigated a SAG-O, which is actually the equivalent of an ODAC for Europe, and that resulted in a positive CHMP, you know, nod, and then also we've had approval in Switzerland. So we do feel very, very confident on the clinical benefit that Abecma can offer into earlier lines, one, because of our pivotal study with, showing, meeting our primary endpoint of PFS, but also we made the decision to make a patient-centric approach in our trial design by putting prespecified crossover for the trial of KarMMa-3, which did confound the results. We do look forward to being able to go and have a discussion with the advisory committee on our data, to be able to show the clinical benefits, and also to be able to show, the actual impact of the crossover. We, of course, you asked this last night, and I'm sure it's a question that on the minds of folks is about kind of the questions around early deaths. Again, we look very forward to the opportunity to show our data, particularly showing them the role of bridging and actually making sure you debulk patients and the benefit that has for CAR-T, but also really specifically showing in KarMMa-3 that the majority of the early deaths, those patients never received a Abecma in the Abecma arm. So, we do feel confident in the ODAC and the opportunity to have that discussion with the FDA and the advisory committee. Okay. So, on the back of that, assuming everything goes well on Friday and the forthcoming PDUFA goes in your way, how do you still feel about the long-term commercial competitiveness? It'd be great to get the label expansion, but, you know, relative to, you know, Legend out there, how are you thinking about your ability to compete still? Yes. As you've heard on our forthcoming earnings call from Adam and Chris and others, KarMMa-3 is a critical stimulus for our growth for Abecma for a few reasons, of course, because you move into earlier lines, larger population. But the other reason is this is where our profile will work hard for us. As you can remember, our overall profile, when you look at Abecma from an efficacy, safety, and manufacturing, those attributes of safety matter as you move into earlier lines. We've heard this over and over again from TLs. So I do think our profile will work harder for us. We'll be in a much better and more competitive position as we move into earlier lines. So I'm gonna ask you the same question I asked you last night, and that is in terms of how you think about differentiation on safety and specifically on the Parkinsonism relative to your competitors. So I can't speak to 'cause there's no head-to-head comparisons between the two drugs, but what I can say, what I hear from TL, TL do see a difference in the safety profiles, of these two drugs. And I do think, as you move into earlier lines, that profile for a Abecma will matter to physicians as they're making choices into earlier lines. 'Cause you have to remember, these patients with multiple myeloma live for a very, very long time. They will be exposed to multiple lines of therapy, and therefore they wanna be very choiceful as you're pulling a CAR-T into earlier lines on what's the tox profile you're gonna be exposing them to, and how that will impact them over the life of living with multiple myeloma. So I do think this is why, you know, we're confident in our overall profile. Okay. We're gonna come back to cell therapy in a minute. Plenty to talk about. Yeah. You also made some news yesterday around an update on the TIGIT program. It was probably one of the more, you know, additional catalysts people were paying attention to on, you know, for Bristol, this first-line lung opportunity. Stock responded negatively, at least for a portion of the day. When we talked last night, you seemed much more positive on the outcome. Wendy, maybe outline kind of your takeaways from the data and, you know, why you're so positive here. Well, thank you for the question, Carter. We're actually excited about the results. Let's take a step back. We conducted a very large phase II study that really was designed to interrogate the question, "What happens if you add LAG-3 onto a PD-1 in chemotherapy, and would you be able to get incremental efficacy over PD-1 chemotherapy?" We were trying to identify what patient population we could see the incremental efficacy, and we're really pleased with the results of that phase II study. In fact, we did identify a very important and sizable patient population, 20%-30% of eligible patients, that would benefit from a LAG-3 plus PD-1 plus chemo versus PD-1 chemotherapy alone. In fact, we're so excited about the data that our intention is to proceed with a phase III study before the end of this year. and again, we think that this is important because while the bar is quite high when you consider PD-1 in chemotherapy, our confidence is high based on the data that we've seen from the phase II study results. Okay. And this group was prespecified? This was a prespecified group, correct? Okay. And maybe just put that then where that would sit in the broader kind of lung portfolio for Bristol. What do you think? Yeah. So if you think about where Bristol Myers Squibb is from a lung cancer perspective, you know, we continue to be very committed to our Opdivo /Yervoy combination, plus or minus chemo in first-line, non-small cell lung cancer. With the recent acquisition of Mirati, we now have a targeted asset for KRAS non-small cell lung cancer in the second-line setting. And with the recent approval of our asset, Augtyro, for first-line, ROS-positive non-small cell lung cancer, the ability to bring Opdivo plus chemotherapy to market in the first-line setting just allows us to continue to expand BMS's presence in the first-line, non-small cell lung cancer setting. We know that the patient population is large. Some patients are appropriate for immunotherapy-based combinations. Others require targeted therapies to which their disease will be exquisitely sensitive. We're building out our portfolio to meet the spectrum of non-small cell lung cancer patients where they are. Okay. So I know we're not gonna define that prespecified group today, but at what point can we see the data or and then see the phase III design? And to be clear, you know, we're not talking about that subgroup or that specified population today because this is a highly competitive market. And so we do need to kind of temper what we share relative to the competitive set. But you can expect to see the data sometime this fall at the latest. Okay. Okay. Okay. Great. Maybe moving back to cell therapy. Mm-hmm. I alluded to it at the start. You do have the CLL approval here in the very near future. Maybe as you just think about the line extensions here for Breyanzi and the ability to, you know, drive a continued, you know, another layer of growth, can you just talk about the opportunity there? Yeah. Let me let me first start saying, yes, today is our PDUFA date for CLL, assuming approval today. We will be the first and only CAR-T to receive an approval in relapse refractory CLL or SLL. And this is extraordinarily meaningful. If you know the history of CAR-T, it's actually one of the first places CAR-T was studied with CLL. But because of the nature of the disease and the dysfunction of the T cells, it's been very challenging for CAR-T to have success in showing clinical benefit across efficacy and safety. So we're extremely proud that BMS and, and specifically Breyanzi was successful in showing that clinical benefit and look forward to the opportunity to bring this transformation to patients. When we think about CLL, and as you know, we've also had received accelerated approval and have PDUFA dates in May for follicular as well as MCL. When you look at the totality of those three indices in addition to becoming unconstrained on vector, we really do see the opportunity to double the addressable patient population we'll be able to reach with our best-in-class Breyanzi. Well, now, when you think about that op so obviously the label would expand. At the same time, we've heard from peers in the space that there are sort of capacity constraints at the academic center level. How can you kinda continue to drive growth if it seems like the academic centers are gonna maybe be limited in how much more they you know will open up beds, etc.? Yeah. So a couple things there. First thing and foremost, we're looking to expand our treatment site footprint. So we're currently at 120 sites. We'll be at 180 by the end of the year, so expanding that footprint. The other key is making sure you drive patients out of the community, into these treatment centers. So we also have put effort into our community sales forces to be driving referrals into this expanded footprint. Okay. In terms of competitive threat from bispecifics here, how do you see that? We've heard, again, noise from peers that they're sort of nipping at the heels. Certainly seen that in myeloma, but at least in, you know, in NHL, how are you thinking about that? Yeah. And listen, I think it's always great when you have multiple treatment modality and options because every patient can't receive every modality and every option that's available despite the fact that the indication might say so. I think what's key for us is reminding physicians of sequence and the importance of exposing patients to CAR-T in earlier lines because that is what we've seen, particularly data shown in multiple myeloma, that patients get the greatest long-term overall benefit when they're exposed to a CAR-T first and then onto a T cell engager. I also think it's a little bit different in lymphoma. We definitely hear from physicians depending on if it's a more indolent disease versus a more rapid disease. So let's talk about large B cell lymphoma. I think most physicians are very, you know, strong on their opinion, including the community, that patients need to be exposed to a CAR-T. You have a very high, you know, CR rate, and those patients are gonna go on to potentially have, you know, a deep, deep, long-durable response. And that's what in the more indolent diseases you're gonna see, you know, in follicular. I think you'll see it'll be a more competitive dynamic between bispecifics and CAR-Ts, and they'll be so more selective in which patients receive a CAR-T versus bispecifics. Maybe, Wendy, coming back to you, and as we think about the Reblozyl label expansion late last year, had a very strong 4Q. When you think about sort of the, the durability of that, that recent bolus, can you maybe expand upon that a little bit as well as the opportunity to, to maybe broaden the centers that you're in currently? Sure. We continue to expect to see continued growth into this year and beyond for Reblozyl in the first-line setting. So what we actually saw last year after the launch was rapid uptake in the first-line setting, both in the RS-positive and in the RS-negative patient population. Naturally, we saw uptake faster in the RS-positive patient population, which makes sense because that's where the second-line indication was approved. But we also saw growth in RS-negative. Where are we headed now? Our growth this year will really come from first-line RS-negative patients. That's the largest population. And specifically, we're focused on RS-negative patients with an EPO level of 200 and below. I think the other important thing to consider is while our initial launch success was both in the academic centers as well as in the community setting, we're really focused on driving uptake in the community setting because that's where the vast majority of these patients sit. More than 70% of MDS patients are treated in the community. I think, in terms of expansion further this year, we're really gonna be also focused on expanding our new user base. So right now, roughly two-thirds of our prescribers are physicians that were prescribing Reblozyl when it only had a second-line approval. One-third of our prescribers, which is exciting, are new to brand, where we can exceed our expectations will continue to grow the new-to-brand prescriber base. So it's clearly still early days in the launch, but, you know, sort of your view on direction and how that will evolve in earlier line settings relative to the initial, approved label? Yes. So I agree with you. It's early days of launch, but we've been committed since day one of this expanded approval to making sure we're educating our physicians on effective titration of Reblozyl because we know that when patients are titrated to the right dose, they're able to stay on therapy longer, which is really good for their outcomes. I also think we continue to educate our community through our certified nurse consultants as well as all of our customer-facing team. But I think it's also important to note that as we continue to drive uptake in the first-line setting and we're getting patients with EPO levels of 200 or below or patients who have lower transfusion burden, you're naturally gonna see the outcome of that being along the duration of therapy. Maybe last question on Reblozyl. Myelofibrosis, it's taken a while to kinda get going. You know, at this point, your level of confidence in sort of the timelines you've communicated and remind us exactly what those timelines are and how you think about that incremental opportunity over the indications you already have. We expect to see data from the independent study. That's the myelofibrosis study next year. We are confident that our timelines we're tracking consistent with what we previously communicated. We remain again, we remain committed and excited about the opportunity and unmet need induced by myelofibrosis. We see a significant unmet need, and we know that Reblozyl will be an effective treatment. We believe Reblozyl will be an effective treatment. Recent competitive data and, you know, acquisition by a larger company doesn't change that view in your mind? We still think that we have a strong place. I think the competitive asset that you may be referring to is intended, as discussed, to potentially be disease modifying, but only time will tell whether or not that's actually correct. Okay. Maybe going back to Lynelle, one of the things we've, you know, seen certainly over the past six months is to sort of, we've referred to it at certainly in print as sort of a land grab in sort of the CD19 into autoimmune. You guys have been out, out in front. But, you know, talk about, you know, you know, Bristol's effort right, right now there and, how you how you sort of stay ahead of the competition here and to the extent that you think the, the importance of being first to market here. Yeah. Let me first just start with why it is so extraordinarily exciting of bringing a CD19 CAR into autoimmune. So if you've had the opportunity to see Georg's data, Georg's data was the data that kind of rocked everyone's world. The idea that you could give a severe lupus nephritis patient an opportunity to have a deep, durable treatment-free response after one infusion of a CD19-targeted CAR was extraordinary. He just showed a New England Journal update and showed that the patients are continuing to have deep, durable responses. He's also expanded that into other B cell-mediated autoimmune disorders and shown that same deep, durable treatment-free result in diseases like myositis and scleroderma. And so for us, we're extraordinarily excited about the opportunity. We also are in a unique position. We're in a unique position because we have a best-in-class CD19 construct in Breyanzi that now we have put on an optimized manufacturing process, which is now our CD19 NEX-T program. And I say that we're extraordinarily excited about that because we've had years of experience of understanding the overall profile of our CD19 construct, both from a safety and efficacy. And we also have a very strong understanding of manufacturing process. And so the experience and the capabilities we have in cell therapy, along with their depth of experience and understanding in autoimmune, puts BMS in a unique position to lead in this space. And we're super excited as well that our lead PI is Georg Schett, which makes it even more exciting to be working with a world-renowned thought leader in this space as we accelerate our program. So yes, it's a crowded space. Anytime you see transformational results, anytime you see a potential of bringing a potential cure—I mean, obviously, early, early days—to places and diseases that were considered incurable, you're gonna get a tremendous amount of activity and excitement from the industry. And we're excited to be one of those companies that we think is well positioned to lead based upon, as I said, the construct, you know, our thought leader that we're working very closely with is our lead PI, as well as our deep capabilities across CAR-T and autoimmune. Any key lessons from the CD19s, the BCMA in terms of importance of being first to market or other aspects you'd highlight? We think being first to market is really, really important here for a couple reasons. Unlike when we're treating in cancer, we're dealing with a, you know, an incidence space, right? So you're dealing with incidence space. If you are able to show, depending on how these profiles emerge through their pivotal data, if those profiles look as we are seeing in the early data and you're seeing these types of responses, you're gonna be dipping into a prevalence pool. So you're gonna be dipping into a much larger pool of patients. So that's why we think it's extremely important to being one of the very first companies into this space and being scalable. And that's why we have a huge focus across both of those dimensions. Okay. As we think about those individual indications, any sense on sort of timelines to data and maybe delineate the individual indications you're going after? Yes. We don't get into the specifics just to say that we're going after for all four populations. I didn't mention MS yet. We have an IND in MS, and we're also recruiting there as well. So again, our indications that we're currently recruiting are SLE, myositis, scleroderma, and MS. All of them are actively recruiting. We do hope to show data later this year. I guess one of the other questions we get all the time is, given we've seen the challenges in oncology, you know, then potentially massively expanding the population, how are you gonna be able to keep up with that? How is the field gonna be able to keep up with that? Yeah. So there's a few key things. One, there's been significant advancements from our first-generation autologous program to our pipelines. And that comes mostly in two areas. One, we're all using next-generation technology on vector, which means that you have high-yield, vector solutions that make vector a non-issue, moving forward. Secondly, and most importantly, is fully automating your manufacturing process end-to-end so that you actually are able to scale, because you take less footprint in your manufacturing buildings when you actually are fully automated. And it actually helps you with turnaround time, excuse me, and speed to patient. Okay. Maybe, certainly, something you can both talk about is sort of, you know, how you see the evolution of the multiple myeloma landscape. Certainly, in terms of your longer-term projections, a big part of that is the cell mods that are potentially gonna be launching the latter half of this decade. But I think from the outside looking in, you have a lot of different pieces that potentially could fit different segment you know, different segments. And it's been challenging for, I think, for investors to figure out, "Okay. Well, if that's this asset's gonna go there, this asset's gonna go there." Meanwhile, CAR-T could be an answer to a lot of those different segments. So. Maybe I'll start. I'll start. And I'll bring Wendy in. I think when you think about multiple myeloma, it's a highly fragmented disease treated very different ways for those different patient populations. We're really proud that we have multiple different types of modalities that can treat different patients' needs across the journey of multiple myeloma. And so yes, a CAR-T gives somebody a one-time infusion, a long-time treatment-free, which is certainly liquid gold to a patient when you think about the with the long time that they're gonna live with the disease. But there are many patients who cannot receive CAR-Ts. Also, CAR-Ts in complements and sequencing and potentially combinations are also what we're exploring with cell mods, with T-cell engagers. So the fact that we have a full portfolio means we're gonna be able to treat more patients and address more needs in this very, you know, insidious disease. So for us, we feel very proud of our overall portfolio. I, I don't know, Wendy, if you wanna further comment on the CELMoDs and the T-cell engager. Yeah. I would agree with you, Lynelle. If you kinda start at the beginning of a patient's journey with multiple myeloma, when first diagnosed, they end up most will get a stem cell transplant. And after they get their transplant, if successful, they'll be treated with maintenance therapy. And historically, that's been Revlimid. Well, we believe iberdomide, one of our CELMoDs, would be an appropriate choice for those patients because what do we know? We know that iberdomide is more specific. We know that it's more potent and more efficient than Revlimid. We also know that the side effect profile is better than Revlimid. So it becomes a really important option as a maintenance therapy for patients. The other thing we know about iberdomide relative to Rev and Pom is that it works after patients have actually either not responded or progressed on Revlimid and Pom. So we know that it's a more effective agent. Beyond that, if a patient gets the stem cell and they don't respond, then it opens up a myriad of opportunities, as Lynelle mentioned, you know, cell therapy if appropriate. But you will still have some patients that are not able or choose not to go to cell therapy centers to be treated with cell therapy. You may have some patients who just wanna be treated in the community by their physicians. And again, CELMoDs are an important option because they're oral, and they're easily combinable. I think it's also important to note, and Lynelle mentioned this, fortunately, patients with multiple myeloma are living longer. When they live longer, there is a greater probability that their disease will ultimately progress on a current therapy, and they will need more options. We see CELMoDs being critically important. Now, we do have bispecific development as well. We believe that our bispecific alnuctamab is gonna be a next generation with enhanced efficacy over what we did today. I couldn't agree with Lynelle more. I see the role for cell therapy and bispecifics as a bridging therapy to cell therapy, as maintenance therapy, and as part of combinations, as core therapy in the future. As we come down to the last minute, I want to leave a question for both of you. You both have a lot more insight into, into what's going on internally at Bristol, into the trials, the platforms, how you guys see the market. What do you think is gonna be the biggest surprises over the next five years across the oncology and cell therapy business? Let me just say, I think it's an extraordinary time for BMS as we kinda move the next chapter of BMS. And we have an extraordinary pipeline, and we have a bevy of new products that we are launching around the world. And we're quite excited about the opportunity that presents itself in front of us. And when I think about the next five years - and obviously, I'll go back specific to cell therapy - listen, if we can bring the promise of a deep, durable treatment-free remission with one single infusion to diseases in B you know, in autoimmune disease, I think that will just be an unlocking of promise that would be just extraordinary. I, I agree. I think the promise of cell therapy and autoimmune disease is huge. But I'm also incredibly excited about our recent acquisition of RayzeBio. Through that acquisition, not only do we get an asset, but we get an IND engine and a manufacturing capacity in one acquisition. And I think the RayzeBio radiotherapy platform complements the work that Lynelle was leading for the organization with cell therapy platforms. I'm also incredibly excited about the SystImmune co-promotion, co-development opportunity. Again, it's an antibody-drug conjugate that allows BMS to further entrench itself potentially in lung cancer as well as into breast cancer. So I think there's a very, very bright future ahead for BMS. All right. Well, we'll have to leave it there. Bristol, thank you very much, and best of luck with it. Thank you. Thank you.