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

Thank you all so much for being here. And Lynelle, thank you so much for being here with us today. For those of you who don't know me, my name is Courtney Breen. I am the large-cap analyst here at Bernstein covering all of our U.S. names, Bristol included. And I am very, very proud and happy to share the stage today with Lynelle here from Bristol. She is the Head of the cell therapy business. And we're going to have a bit of a conversation around kind of particularly the potential in cell therapy, how it's landing in the hematology space, predominantly where it is today, where it might be going in the future. And so really, really excited to talk about this because I think we've got some proof points now, but there's a lot of innovation on the horizon, which is really, really exciting. Perhaps before we dig into that, I'd love to hear, Lynelle, you just open with a couple of comments from your side. Anything you want to say to set the stage and set some context about your background and the conversation we're going to have.

Yes. Well, first of all, thank you, Courtney, and thank you for Bernstein for having me and BMS represented here today. And certainly, I'm excited to have a 40-minute conversation about cell therapy. I have passionately been involved in this particular business for 4 years. And I think to myself, when I go back when it all started for BMS, we embarked -- we were launching the very first CAR-T in multiple myeloma. We were going to be launching the third to market CD19 CAR-T, and there was a lot of unknowns. There was unknowns about how durable would these CAR-Ts be? Would they be successfully able to move up into earlier lines? What was the access and reimbursement landscape really going to look like? How are you going to be moving it into global markets? And could you scale and scale in a way that could allow you to have a marketplace that was very viable. And so as we sit 4 years later, and I know after treating 13,000 patients, and we sit in a unique position as Bristol-Myers Squibb, where we have more manufactured clinical and translational data almost anyone else in this space. And it has afforded us the opportunity not only to grow our in-line assets, but it helps to accelerate our pipeline. And I think now when I sit here, we have near-term best-in-class, first-in-class CAR-Ts with our GPRC5D known as arlo-cel, our dual targeting CAR BCMA and GPRC5D in multiple myeloma as well as probably the asset you guys mostly asked us about, which is our CD19 NEX-T. And for obvious reasons, the field is really excited because they want to know, are these deep, durable treatment-free remissions with a onetime infusion, are they possible in diseases where functional cures were not even thought of 3 years ago. And so we're really, really excited about the potential of what CAR-T can bring to the autoimmune space as well as neuroinflammatory. And so for us, we're super excited about cell therapy. We understand some of the challenges with cell therapy, but we do believe we're at a really important inflection point to bring the promise of cell therapy to more populations, more people as we continue to grow the class and move into other disease areas.

Fantastic. That is a perfect opening for where I wanted to start because I did really want to start on some of those market factors and kind of how the health care systems have potentially limited some of the use that perhaps if you look back 10 years, people were hoping to see by this point. There has begun to be enhanced utilization, but then we've also got bispecifics perhaps coming in and competing with the class as well in certain places. As you look forward kind of 10 years into the future in the [ heme'd ] space, let's just kind of start there because there's many other places we can go. But in hematology, the next 10 years, what does good look like in terms of the potential for cell therapies? And what unlock are really important in terms of the health care system, be it access, be it kind of the way that the system works to ensure that these patients who need access can get access to these products.

I think it's always important to start with why has CAR-T not taken off like you see, for example, I spent a big part of my career in checkpoint inhibitors, the PD-1 space. And you would launch a new indication with the PD-1s in about 6 to 9 months, you were at peak class share, and you were anywhere between 60 and 70 depending on the actual indication, and it was pretty quick. But there was obviously factors in play there that are not in play for CAR-T because if you look at the efficacy and the transformational impact for patients, not too different than what you see with checkpoint inhibitors. You're giving people curative intent and the probably benefit of a CAR-T, it's a onetime infusion. So you take somebody from being reminded that they are a patient with every dose, every swallow the pill, every tox, every side effect to being a person again after experiencing CAR-T. And so from that standpoint, what you really start unpacking is what are those limitations. And those limitations initially, everybody thought it was the manufacturers couldn't scale. And candidly, that was true, including BMS. But once the manufacturers were able to figure out how to move and automate in certain components as well as scale operationally, now we are unlimited in our ability to supply the marketplaces, including moving up into earlier lines. And so then you really started unveiling what were the real dynamics in play here that were limiting a CAR-T. And it's pretty simple when you really take a step back and look at it. One is the CAR-Ts are not delivered in every community practice. And so most patients, 70% of them are treated in community practices around the United States. That dynamic is consistent in Germany. It also exists in Japan. Probably the one unique market is France, where CAR-T class is its highest in the world. It's at 40% CAR-T class is in France. And that's because it's an ecosystem that basically operates as one between community and academic center. And therefore, patients come into the fold to determine what is the best mode and modality of treatment and then they go get that treatment. In the United States, patients -- most of the patients are initially diagnosed with their community medical oncologists. And it's at that time, will the community medical oncologists refer that patient to a CAR-T center or potentially reach to another modality that's available to them. And this is where TCs have certainly put pressure on CAR-Ts. I think when you talk to every single physician, I mean almost every single physician to a physician, they will say, CAR-T is curative intent. A TC is not. And so I always challenge physicians in the community with, if this was your loved one, what would you want? And to a person, they want them on a CAR-T. And the reason is because they recognize what the intent of the treatment is. And so really it goes into their mind of I have to think about the patients, will they have the right treatment team around them? Will they be able to be at the treatment center for that length of time? Will they be able to have the right support. And so one of the big green shoots that recently happened for us was the reduction of REMS and the reduction of some of the patient burden in the label because as one physician told me, 4 weeks at a treatment center an academic center is like a sentence, versus 2 weeks is a vacation. Now I won't say who said that, and I won't determine whether that's true and either and maybe it depends on the academic center. But the bottom line is the point is 2 weeks is more rational for a patient and their caregiver to be away from family and other commitments to go receive a CAR-T. So I do think we expect some momentum coming from that decision. I also think the other dynamic is even if and when that momentum starts really building and you start seeing referrals increasing community physicians start seeing that they can get their patient back in 2 weeks, there will still be physicians and patients who want to stay physically treated in the community, which is why we have a huge push right now on bringing CAR-T to the community, literally infused in the community at a community center. And we have 2 community centers today who deliver CAR-T in the community, that's Virginia Oncology and Tennessee Oncology, both successfully delivering CAR-T. As a matter of fact, Virginia Oncology treated over 90 patients. Dr. Simmons has been publishing on this, and he's successfully and safely delivered CAR-T. So I do think that's the other big green shoot is being able to bring CAR-T to the mega community centers so that CAR-T can be delivered closer to home.

Absolutely. And kind of perhaps zooming in even more near term to kind of delivering on some of this potential. We've seen Bristol perform pretty strongly over the last couple of quarters in the CAR-T space. Kind of -- is this down to kind of the manufacturing unlocks, the kind of out-of-spec kind of scenarios becoming more manageable. You've obviously had some new indications come in. We've had the REMS kind of, what are the most important factors that have enabled you to start competing in a way where if you contrast this with some of your other CAR-T competition that are going up directly up against Breyanzi, we're seeing slowdown there. And so what's different about what's supporting this particular performance for Bristol near term?

Yes. It's important to remind people kind of the journey Breyanzi has been on. So Breyanzi, when we initially launched, we were 3 years to market after the initial 2 CAR-Ts launched in the market. And we were constrained for our first 3 years. So that is not an ideal launch. But 3 months after being constrained and after working through a widening of our spec, it only took us 3 months to become the #1 CD19 CAR-T in the United States. We are now #1 in Germany, Japan and France. So it is that best-in-class profile that has really seen the surge. So when we talk about our current robust strong performance on Breyanzi, that's really the profile working very hard for us. It's also the fact we have the broadest set of indications for B-cell malignancies. We expect also we have a PDUFA date this December for MCL. So it's that profile from efficacy, safety and manufacturing that has afforded us the opportunity. I think now, as I articulated, we do hope to see based on moving into the community and seeing some of that community growth. We also see much of Breyanzi's growth is in the outpatient. Again, back to a differentiation of Breyanzi. Breyanzi's safety profile allows people to move Breyanzi into the outpatient where those patients can be literally infused, sent home and monitored they're close to the center for a couple of weeks, and that is unique to its profile. And so what we are seeing now is most even academic centers are putting Breyanzi into the outpatient, which frees up capacity for them in their inpatient unit for CAR-Ts that they have to deliver in the inpatient. And so for us, we think both profile and the REMS would afford us the opportunity to continue to grow. Now what I will say is CAR-Ts do have seasonality dynamics in the summer months. So we do anticipate seeing some seasonality, but we're really excited to see the second half grow for Breyanzi. Now as far as the REMS, everyone always asks me, how much do you think that class is going to grow. Honestly, it's interesting. Only 2 out of 10 patients today who are eligible for CAR-T are receiving CAR T. And so for -- and that should not be -- back to my point, if I were a patient and I think about being in the United States where health care and access to innovative care should be equal at minimum to France. The question really is how do we get it to higher levels. And that's what we're working hard to do. But it will take time. Just the fact that the label updated, each center has their own SOPs. So each center will determine, am I going to implement this update immediately or take time. And we've done market research with all the major centers that deliver CAR-T today. And I think it's mixed. Some are immediately implementing the 2 weeks staying at the center and 2 weeks back into the community. Others are doing it patient dependent. So a high-risk patient versus some are doing it CAR-T specific. So they're picking certain CAR-Ts. They feel that they could administer outpatient. Of course, we're on the good end of that decision. And then some are still like doing a wait and see, like I want to wait and see. So I don't think that while the REMS is a green shoot, I don't think we're going to see this immediate pop for the CAR-T class. I think this will be something that takes time.

That slowly evolves. And kind of as you think about that eventual split of what might be achievable outpatient versus inpatient, what could the future look like in terms of how many patients are managed in a more outpatient way?

So I think it's really hard to put a number on it. I know everyone wants us to and I understand. But I think for us, it's very difficult to quantify that. I think what we -- how we think about it internally is make sure we're in the position to be able to supply in that place, and we feel very, very confident in that. And obviously, our goal is to make sure that the unlock for CAR-T happens for patients because to every patient I speak to that gets a CAR-T says the only thing I regret that was I didn't get it earlier that I went on to get other modalities where I was continually getting either infused or taking an oral and I had no idea I had an option like a CAR-T. And so for us, we will continue to work to get patients that ideal modality.

Absolutely. That makes a lot of sense. And maybe pivoting to kind of innovation, and I think there's quite a few fronts here. As we look at kind of your current later-stage pipeline, and you referenced a couple upfront, there is real innovation and kind of the targeting capability of the CAR-T, kind of you've got, your GPRC5D, you've got your dual kind of targeting options, which are kind of pushing the boundaries in terms of how we can apply CAR-T to some of these patients. There is also other innovations going on, the kind of idea of in vivo expansion, the idea of off-the-shelf CAR-T options, kind of as you think about long-term innovation in this space, what parameters are really important in innovation as you look at the portfolio that Bristol has or the portfolio that you would like Bristol to have over the long run?

I think it's a really, really great question. When we originally kind of got into the cell therapy business through the acquisition of Celgene, which acquired Juno and obviously, the partnership with Bluebird Bio. At that time, the world was an autologous world, but there was a further pitch growing on HD allos. And we took a very methodical approach of really understanding could an HD allo hit the efficacy bar that an auto CAR T could. And the first gen really struggled. And I think you guys have seen many of those companies kind of hit a certain state as a result of not hitting those kind of efficacy bars. But we have also recognized an autologous CAR-T will have a ceiling. And so if you believe in the power of cell therapy, then we need to be making and have been making investments to unpack off-the-shelf solutions as well as continuing to accelerate auto CAR-Ts because either in a world 10, 20 years from now where you might have coexisting auto versus HD allos versus in vivos or where a world where you start seeing some of these off-the-shelf take over auto CAR-T, you want to be in a position to be able to make multiple bets. And so for us, we're excited that we are -- we've been patient, and we've waited until we have the right construct and tested that construct in multiple different ways. And we have our first HD allo that we are -- we've taken into clinic. We have our first visit for an HD allo. It's an HD allo for CD19 specifically designed for autoimmune we do think the highest proof of concept is in autoimmune. We say that because if you look at why the HD allo CAR-Ts have struggled in oncology, it is because they can't get that same level of persistence that's needed for the durable tails that you see and need in oncology. And that might not be needed in autoimmune because after all, what they're seeing to get this deep B-cell aplasia through the periphery and through the tissue, it does not necessarily need the persistence, it needs the depth. And so we feel pretty confident with our HD allo construct that it might actually be something that can achieve that. So obviously, we'll prove that out in experiments and see if that scientifically works out. So we're quite excited to see that approach. But we've also been making investments in vivo. I think in vivo is an interesting platform. Obviously, it's much, much earlier and further out, but I think that is another great concept of can you potentially give a patient almost like a vaccine shot and provide them that same kind of CAR expression and so early data looks super intriguing and interesting. And so we've been watching that field quite closely.

Fantastic. And I think there's lots of kind of add-ons that you can think of in the in vivo space of how do we get that immune system response to be as robust as possible and as reactive as possible as well. Maybe zooming in on those kind of key pipeline opportunities. I think arlo-cel is kind of the nearest on the horizon and the one that people are spending a lot of time a lot of time on. Multiple myeloma is a pretty mature market when it comes to innovation, when it comes to the -- sorry, the cell therapy opportunities, but also when it comes to kind of the bispecifics, and you've got some players there being very dominant across different modalities. How do you think about kind of your construct, why it's exciting and how you anticipate that entry in the market to look given the environment that you'll be entering?

Yes. So when you look at the multiple myeloma market, you still see a market where we haven't yet found a cure where we still have patients that are progressing. And now we have a market where we have patients that are quad, class exposed and really have nowhere to go. And so when we think about the role of GPRC5D, we see a growing marketplace of opportunity because more and more patients as BCMA TCs and CAR-Ts move up into earlier lines, you're having more of those patients that are quad exposed and needing a place to transition to after. And so what we're excited about arlo-cel it gives you optionality. And we talk to a lot of physicians. And initially, when we saw our data, we were really excited about its efficacy. I think what the 2 big ahas for the field were, one was it actually -- the efficacy looks great in BCMA naive as well as BCMA exposed. So that was very intriguing for physicians. So they were pushing us to look at BCMA naive. And then the second was really a safety profile. I think a lot of people understood that 5D was a relevant target in multi myeloma. But the challenge was ongoing pressure on that target really has very high unwanted tox profile. And so from our standpoint, based on what they've seen with the TC that was in the market. And so when they were able to see putting pressure on that antigen one time actually gives you the efficacy benefit, but without as much many of the liabilities of the on-target off-tumor toxicity. So from that standpoint, we really are excited about arlo-cel. So as you know, we have 2 registrational studies ongoing right now. The first one, obviously, that we expect for data for next year is our relapsed/refractory multiple myeloma for that quad-exposed population. So we're super excited about that based on what we saw in our Phase I. So we hope to see that data play out in our pivotal. And then, of course, we've also begun our earlier QUINTESSENTIAL-2 trial that, that actually is in the second line to fourth-line patient population. So we're quite excited about the promise of that asset and what it can bring in the marketplace.

And it certainly sounds because you're going after a different target, your kind of flexibility around sequencing is much more likely to kind of give you potential for utilization in a number of different places for a number of different patients. Is that how you taking the opportunity...

100% how we think about it. The one thing you can talk about multiple myeloma, there's lots of assets, but there's lots of strategies. In other words, it's very heterogeneous, not only in the patients, but also in how physicians treat. And I think having assets that give you utility across multiple different approaches is very flexible for physicians and flexible for patients. So I think that's what GPRC5D offers.

Absolutely. I think the more we see that physicians have tools at their disposal, the more art kind of that comes into the way that they deploy their science. As we look at kind of that pivotal readout in 2026, kind of what should we be expecting to see? Kind of how should we be thinking about that particular readout? And also, we're seeing a lot of changes in the FDA, HHS, et cetera. And I know that this is a line that all the companies are having to navigate and walk. Can you just talk about any interactions that you're having with kind of the bureaucracy and with the policy side of the equation? As to whether this will look different or similar to what we've seen be applied to cell therapy in the past.

Yes. So far, the FDA has not -- we've had no experiences that would make us feel as though that either advice they have been giving us on an ongoing basis has changed. And one of the greatest signals I've said to people that they have to remember, the label updates with the REMS, which started with Peter Marks, then handed over to Nicole Vern, but also brought over the loan by Bernad Prasad. So I honestly have not -- we have not seen any changes in the FDA's temperament. Obviously, there's been reasons that people have concerns and questions, et cetera. But when it comes to GPRC5D, this is an asset, the primary endpoints are not tied to MRD. I think that's everybody's question mark. This endpoint is not tied to that. And so we do expect no issues from that standpoint. And we hope that we can replicate what we saw in Phase I, which was a very promising efficacy and safety profile. So that's what we hope to bring to the market.

Fantastic. Fantastic. I think we'll be looking at that one very, very closely. The other thing that I wanted to ask is you're now looking at the dual targeting, is the next kind of cab off the rank as we think about after arlo-cel. What do you hope to achieve there, particularly in the context of the sequencing conversation we just had and kind of the use of BCMA kind of targeting agents across the board in multiple myeloma. How do you think about kind of this opportunity. And we've also seen kind of bispecifics kind of on the mAb side of the equation, cause different types of outcomes or different types of tox for patients as well as we look at kind of more dual targeting in the cell therapy space. Is there anything we need to watch out for there?

I think what people have to remember, there's still an enormously high unmet need in this newly diagnosed multiple myeloma patient population. As we think about the dual CAR, we are looking to try to bring an asset with curative intent up into that newly diagnosed patient population where the unmet need is still really high. There is still a lot of physicians who say in their mind, while some of the CAR-Ts have proven to show really great efficacy, they come with some liabilities and concerns and those liabilities make them wonder, should I be exposing a patient into an earlier line like a newly diagnosed patient or should I be waiting because of the risk-benefit equation. So what our hope is here is that we can balance both great efficacy and deep durable responses along with a safety profile that would allow it to address that still remaining high unmet medical need in newly diagnosed multiple myeloma. So we are obviously excited about this asset. We are moving forward at a very high pace in our dose-finding trial. And we're looking forward to hopefully being able to release data on that and really hopefully see what kind of asset we have. The reason we're excited about it as well is 2 things. One, if you remember, and it was an ASCO/ARGO, which seems like an eternity, when you started seeing bispecifics hitting 5D as well as, you were seeing tremendous efficacy. But what you were seeing was a lot of safety liabilities, which I think is what you're alluding to. And we do believe back to what we've seen with GPRC5D, when you put pressure on targets on time and especially excuse me, I should say, in a bispecific designed CAR, you are also getting the nature of avidity. So you're not only putting pressure once, you're getting avidity, which we do believe will buy down some of the side effect liabilities. Now obviously, data will have to prove that out. That's why we're doing the scientific experiment. But we do have a lot of enthusiasm for what this can bring. And I can tell you for the physicians who are involved in this trial, there's a lot of excitement building for this approach.

Fantastic. And I did see that you had the Iber data that came out this morning, also in the multiple myeloma space. We won't dive into that deeply here, but it seems like kind of Bristol is going to be in that position to be able to play across kind of a number of different assets as well, which is obviously valuable.

Super important for multiple myeloma leadership as a company.

Absolutely. I did want to make sure that we've had a good chance to spend some time on immunology. And this is because as I think about CAR-T, and I think the way that you set this up as well, this is the next frontier as we think about kind of where this innovation and technology can be deployed. Maybe just starting at the highest level, a very simple question. What kind of patients are potentially relevant for CAR-T when we think about immunology. Is it the sickest of the sick that have been kind of experiencing kind of very refractory kind of autoimmune diseases? Or is there a path to this being a broader patient population?

So right now, obviously, our trials are designed for kind of that refractory severe population. I think there's 2 things to remember. One, that's naturally where we should start, obviously, to kind of understand the risk benefit of the modality in this patient population. But what I have to always remind people, including internally, that hematology, when you compare the population that CAR-T is in today there versus the severe refractory population in autoimmune, you're talking anywhere between 3 to 5x the patient population size. And the reason for autoimmune disorders are much bigger populations than what we see in hematology. So already, you see a very sizable marketplace. But what we've also been seeing based on the data that's been already out there in the marketplace, including our own in auto-CAR-Ts, a lot of physicians are saying, well, listen, a lot of the severity has been organ involvement and organ damage. Some of it's not reversible, and this is why people have seen some of this proteinuria that exists in SLE, for example. And the reason for that is you can't reverse organ damage. And so there's a lot of physicians who are pushing us to try to move these things into more of these mild to moderate patient severity. Obviously, that will determine based on when these profiles completely read out because, of course, you want to be able to say, can you replicate what you did in kind of the early work in your later work? And if that does happen and you start seeing a risk-benefit profile be such, of course, you're going to see both patients and physicians want to move these into earlier lines or in this case, into patients without as much severity or organ involvement.

Fantastic. And just kind of understanding that scale of even the refractory patients is quite impactful when we think about the long-term opportunity, as you said.

And I can't help but go back for a second for the patients because I think about some of our patients that we've already treated with our CD19 CAR-T that we've published on or at AACR. I mean, these are patients in their 30s. I mean we -- these diseases are robbing them of their life. And so to think about what a CAR-T has now provided these patients who are now treatment-free and disease-free. I mean these were patients that were told about their diagnosis and they were told that they were going to be put on immune modulators through the rest of their life, some of them with such high doses of steroids that they would not be able to rear children and to be able to think that they could potentially get a CAR-T and have one of these responses and have a new lease on life. And so for us, the excitement is really palpable and what's potentially here for patients.

Absolutely. Absolutely. And I think kind of this investment in the CAR-T space and immunology has been part of a perhaps broader rethink of Bristol around immunology kind of we saw your spin-off more recently. And I think you spoke in that announcement in terms of really focusing on assets that have the potential to reset the immune system and promote tissue repair and that ability to invest in areas where Bristol is kind of best positioned to lead. As you think about kind of this similar to how we just mentioned on the multiple myeloma space, kind of multiple assets there that sit around the CAR-T space. Do you think about the ideal portfolio in the immunology space, kind of what role does CAR-T have in that strategy?

So when it comes to the immune reset, I think it's really the cornerstone, right? Because the efficacy bar has been established by auto CAR-Ts. So what everyone is now doing, including ourselves with the -- moving our HD allos CD19 into the clinic is trying to determine, can you reach that same efficacy bar with a more off-the-shelf solution so you can bring it into the community rheumatologists offices. And so when we think about kind of where CAR-T sits, we think it has set the bar. And the question is, can we replicate that with other shots on goal, and that's what we're continuing to explore as a company.

That's super exciting. And maybe just diving into the CD19 NEX-T. Tell me about that asset and why this asset feels like the right one for you to really pursue at this point in time with what we know about CAR-T in the immunology space.

The first thing that people need to know about our CD19 NEX-T is Breyanzi's construct that we put on to a shorter manufacturing process onto a single train. And so we have years and years of understanding translationally clinically in manufacturing from Breyanzi that has fueled our excitement on what this construct can bring from an efficacy and safety standpoint. So that understanding builds really great excitement. And then, of course, we've now seen this product perform in multiple different disease areas from SLE to MS to scleroderma and myositis, et cetera. And we're really excited about what it's performing and what we hoped it would do as far as getting deep B-cell aplasia, both in periphery and the tissue and making sure that we truly induce this immune reset. And what we're seeing is these patients indeed are coming off their immune modulators and are disease-free. So this for us is why we're really excited about this asset and its potential. It's why we also were really aggressive in our CDP, our clinical development plan. We have Breakthrough 1, Breakthrough 2 as well as our breakthrough SLE, all kind of in parallel. Typically, in autoimmune, you kind of test an asset in a disease, you wait to see what it does and then you kind of move into other diseases. And we have been so bold based on what we saw early that we wanted to go out into these basket trial designs to go after multiple populations at one time to be able to accelerate kind of our position across multiple indications, I should say.

Absolutely. And I think kind of this there's so many pressures on pharma companies and on kind of pharma innovation that it's becoming more and more important to take on risks like that because you've got competition coming or because you've got kind of -- maybe not in the CAR-T space in the same way, but you've got kind of the Inflation Reduction Act kind of kicking off your time. You've got kind of the need to run those parallel trials in a way that perhaps in the past would have been sequential. And so balancing that risk reward becomes really complex and really important. As we think about this innovation, kind of we've talked a bit about the science on the immunology side and why this is exciting. We began this conversation though with kind of why has this been hard for us to achieve real impact on a broad basis in heme. As we look forward in the immunology space, what needs to happen? And what are you doing today? And what do you anticipate doing over the next 3 to 5 years as you're advancing this asset in the clinic to make sure that kind of your rheumatologists, your other kind of immune doctors, inflammation and immune doctors around the world are in a position to deploy these products for the right patients at the right time.

Yes. We asked this very question when we decided to put this asset in the clinic was what would have to be true for this to be a meaningful market. And it's why right upon putting into clinic, we developed something called the Action Network. And it is a body of physicians who are advising us at the top rheumatologists along with hematologists and neurologists, informing not just how to clinically unpack a CD19 CAR-T, but also how do we actually create an ecosystem that allows for rheumatologists and hematologists to work more in partnership to both identify who's eligible for these CAR-Ts, but to ensure that these patients get access to CAR-T because we recognize if it was a struggle in lymphoma for only 2 in 10, it will be a bigger challenge in rheumatology. And so we have started the work now, not upon approvals to create an ecosystem that allows for CAR-T to be more broadly used.

Fantastic. And can you contrast for me kind of the U.S. versus the ex U.S. space here because I think health care systems look really different around the world. The treatment of physicians often look different. Even the kind of degree of innovation that's made it from the U.S. to the ex U.S., particularly in the immunology space can be quite drastically different. And so how do you see this becoming either a global product or more of a U.S. kind of opportunity in the first years?

We are certainly designing this to be a global product. And my first measuring stick on whether or not there is global interest is how well the trial is recruiting. And I can tell you globally, the trial is recruiting really well. And so there is a high desire in markets to be able to bring this type of innovation to patients. And so for us, that's why we are working not just in the United States to create this ecosystem. Many of the people on our action network are not just United States-based, but they're also European-based, et cetera. So we are looking to try to help support an ecosystem more broadly. But the dynamics you're talking about are real. There are some markets where those dynamics are harder where the receptivity to innovation and the price of innovation is not there. And obviously, that makes it a bit more challenging. But certainly, I think when it comes to the desire to deliver that kind of innovation to patients, that is very -- that exists in every country we've been bringing CAR-T into.

Absolutely. And so maybe in our last kind of few minutes, I would love to just get your thoughts on if you're sitting here in this role in kind of 5, 10 years in the future, what does cell therapy look like at Bristol by then? And kind of what will you feel kind of needs to be true for Bristol to have said that we've succeeded in delivering against the opportunities in the cell therapy space?

No, it's a great question. It's when we have our vision statement around unlocking the full potential of CAR-T is grounded in us delivering this transformational modality to over 100,000 patients. And I do know that when we first made that ambition 4 years ago, it didn't feel fully plausible, but you wanted to have people starting rallying behind something that seemed maybe a bit impossible, but to then see them along the way, making it possible. And we're getting there through strides of innovative science that's moving into other disease areas. We're getting there through moving to automation for our autologous, and we're going to get there also by moving to off-the-shelf designs and solutions. So for us, success looks like that not only do we achieve the 100,000 patients that we see patients in diseases where functional cure wasn't possible at is possible. And that to us will be something that I hope in 5 years, I can sit in front of you at this panel and say that we've done.

That is fantastic. And my final question because I think this is always a fun one is -- what are the questions that you get that you think kind of you want to clarify? Like is there something where you say people really misunderstand this thing about kind of cell therapy and about our opportunity going forward?

I do think it starts with when people kind of say why CAR-T. And then I remind them to put them in the shoes of a patient and say to themselves, would you like door #1 is 1 and 2 chance, and this is -- I'm talking about diffuse large B-cell lymphoma, but diffuse large B-cell lymphoma, you're progressing off R-CHOP within 12 months. Do you want door #1, which is a onetime infusion that you have a 1 in 2 chance for a cure? Or do you want door #2, where I'm not going to give curative intent, but I'm going to be able to treat you and you might have a long PFS, but you're going to be coming in for ongoing doses, et cetera. I mean I just don't know a person in the planet who chooses door #2. And so for me, it's that constant reminder of why door #1. It comes with additional complexities and other considerations. But for me, that's what we should be good about in the health care system is how do you remove those complexities so that more patients can choose who are #1.

That's fantastic. And one thing that you said earlier on that I do want to finish on, you spoke about the fact that kind of a 2-week vacation is very, very different.

That was the physician who said that.

To the longer-term version. I have just spent 5 weeks living out of a suitcase. And I can tell you 2 weeks living out of a suitcase is so much nicer than 5 weeks to be honest. I do resonate with that perspective. But thank you so much for time and all.

Thank you, Courtney.

This has been wonderful. I feel like we've managed to dive into a whole lot of detail around kind of where Bristol is going in the future and kind of what unlocks are required in the cell therapy space. And we're really excited to see this innovation come to patients and have real impact. So thank you so much.

Perfect. Thank you so much, Courtney. Appreciate it.