All right, great! Well, we're very pleased to have TSVT here with the CEO, Chip Baird, and Vicki Eatwell, CFO. Maybe to start, you know, a lot has happened for you guys over the past six months. You had the, the restructuring, sale of your assets to Regeneron, and then more recently, the third line approval. Maybe just kind of high level, how are you guys positioned going into the second half? Yeah, sure. Matt, thanks for the question. Just start by saying thanks to you and the whole Goldman research team and the broader bank for having us here today. Excited to be here. We'll also say we may make forward-looking statements, so we refer you to our safe harbor and encourage people to do their own homework. We are five months into the year and couldn't be more pleased in terms of the execution and how it's gone so far and what that sets up for in the second half. So, with the sale of the R&D assets to Regeneron, with the successful ODAC meeting and now approval in the third line, with the dramatic changes into our cost structure, we feel very good looking ahead. What those changes mean for us, and really, we get this question a lot from investors, but where are the proof points? I think the first proof point you'll see actually is more on the cost side of the equation. So we have dramatically changed the shape of the company to be Abecma focused, and we've changed the cost structure. And so you should expect to see in the second quarter, a dramatic reduction in the cost structure for the company in OpEx. We'll report that in the July, August time frame. The other thing that is even more important is the return to growth for Abecma. And there, we were approved in the third line setting on April 5th, which is a big day for the company. The way Abecma works, the way most CAR-Ts work, is that from enrollment of a patient to apheresis of the patient, to treatment of the patient, to recognizing the revenue, is about a two-month journey from beginning to end. So the impact of this March larger third line label, we may see small elements of that towards the end of the quarter, but really, it's gonna be the third quarter where you can see in the revenue picture, that return to growth. That doesn't mean that there aren't green shoots or things to be excited about, but in terms of what we can report, we expect that more in the second half of the year, beginning in the third quarter. You know, and we can get into kind of why we believe on that return to growth and, like, what that picture is. But, you know, at a high level, we have some things that are well known and established about the product in terms of a consistent safety profile. We have a manufacturing process that is well-honed now, three years in since commercial launch. So, 25-day turnaround, better than 90% in spec rate. Those things matter with CAR-T patients. I think the real new part of the story that comes with the third line label, that comes with the KarMMa-3 data set, real world evidence, is the efficacy profile of the product. And there, we think we have a competitive efficacy profile. We can get into it more in the conversation here, but all of those things are gonna come together, I think, to drive a real return to growth, and we're excited to to demonstrate that. The last thing I'll say is just with the changes that we've made to the company, we now have runway into 2027, and so we are not in a stance where we need additional capital infusions. We do not expect to take dilution. Mm-hmm. You know, again, we would love to see a steep curve, but whatever the shape of the curve is, as long as it's positive, we have time to play that out, and we're excited to do it. Great. Maybe diving a little bit more into the third line launch, what are the key dynamics in terms of manufacturing capacity, both for you and J&J? Mm-hmm. Competitive dynamics, both... I know now, no longer you, you don't have to worry about bispecifics- Mm-hmm but you do have a maybe more competitive kind of traditional therapy landscape. Mm-hmm. What are the key things you're focused on there? And then physician preferences kind of tied into that, and physician preferences in this earlier line, and then finally, patient access for cell therapy. Yeah. Yeah. Yeah. So, there's a lot there, so just hold me accountable if I don't hit them all. But you know, from a manufacturing perspective, we have the supply we need to meet the demand that we're experiencing today, and we have room to grow. So that's a great position to be in, and it means that for patients who are interested in the product, there's not a delay, which again, for particularly rapidly progressing patients, that matters. And we have, as I said before, a very high in-spec rate, which also matters. You know, from a patient access perspective, we've increased now to 115 sites in the United States. We expect to continue to add to that. Of course, we cover all of the major academic centers, but you know, to get to all the patients, you need a geographic distribution, and we're getting there on that. So we feel good about that. You know, from a physician perspective and from a competitive perspective, we studied triple-class exposed patients in the KarMMa-3 study. That is a patient population that has seen some very effective earlier line therapies, and so we think for those triple-class exposed patients, having a CAR-T product, like Abecma, really meets an unmet need. And so I think that sets up nicely. Again, in terms of other innovative therapies, there are now two CAR-Ts approved in this line of therapy; it's a much bigger market. We were in a market that was 4,000 patients in the, in the, what I'll call a fifth line plus setting. We're now collectively in a market that is more than 16,000 patients in the United States. So, that is... We like the size of that opportunity. We're geared for it. We have a commercial team that is focused on, on delivering in that setting. Mm-hmm. What's a fair estimate for what percent of those 16,000 will be open and kind of easy access to CAR-T? I think it's gonna grow over time. You know, and again, I think we're eight weeks into launch, so, you know, some of these dynamics, if you ask me in a quarter or two, we'll probably have a better sense. But certainly, I think from a patient perspective, the one and done nature of the therapy, the deep and durable responses we've seen, I think make it something that you actually see a patient pull for access to CAR and access earlier, right? You know, we've talked about in the fifth line plus setting, the sequencing of CAR relative to TCEs. And again, when you have a CAR-T available, key opinion leaders would agree that medically, you're gonna drive a better outcome by delivering. Now, in a third line setting, TCEs, again, will be a later therapeutic option, but that the CARs will likely- In terms of the percent of patients, I mean, you don't have the bispecifics. Mm-hmm. Is it fair to assume maybe kind of an equal proportion of patients up from the 4K scaling up to the 16K that would pursue a course? Yeah, I think this is the big question, is how far, as a, you know, we can talk about brand share in a minute. From a class share perspective, how deep can CAR-Ts go into the third line? I think that's an open topic that'll be driven, I think, in the short term by collective capacity for the sponsors in the space. But over time, I would come to a physician experience with the product and, you know... But again, we were close to 50% class share in the fifth line plus setting. And again, I think you get to similar numbers of third line plus setting. That's a very meaningful market, and you know, us making the investments that we've made in terms of scale. Great. Maybe stepping back a little bit, maybe you could give us an overview of the development strategy for Abecma in the earlier lines. I know you guys are looking at the maintenance setting in first line. Mm-hmm. Could that change? Could you look at more? And why did you decide to go after that specific group? Sure. No, it's a good question. So, recall, we've last year started KarMMa-9, which is targeted at newly diagnosed patients who've had a suboptimal response to transplant. And again, when you know, roughly 30,000 patients at the top of the funnel diagnosed with myeloma each year in the United States, you know, a set of those are transplant eligible, a set of those are not transplant eligible. Within the transplant-eligible patients, even with the transplant and now quad therapy following up after that, you know, roughly half of those patients do not achieve complete response. And so that's a meaningful patient population. We've seen from KarMMa-2C, so an earlier study already completed, looking at a similar set of patients. These are patients who had less than a very good partial response, so even kind of a worse prognosis. For those patients, we've had a 77% CR rate, so tough patient population, 77% CR rate. And when they've had len maintenance, no one responds to date. So it gives confidence that this is a study that has a high likelihood of success. And again, as a patient population that, you know, there aren't other options or, or potent options like this available. So we, we, we think it's a good strategy. We're aggressively enrolling that now, BMS. Too soon to say, you know, when will we have data, as we're still on sort of the front end of that enrollment. Could add to the overall opportunity for the product. Mm-hmm. Just contrasting the development plan to maybe Carvykti- Yeah. Could we see this evolve? Could you guys go after more in the first line, or is, is it- You know, I think it's- At this point. ... it's too, too soon to say on that. I, you know, again, I think the strategy there, you know, there's at least, you know, CARTITUDE-6, looking at replacing transplants. So, you know, it's tough to say. I think we have a set of patients in that frontline setting for whom, you know, based on data we've already seen, we think we can make an impact. Mm-hmm. Maybe going back to the third line setting, kind of longer term, obviously, you have Carvykti now that you'll compete with. You won't have bispecifics. So next, I guess, 2025, 2026, it's kind of just you guys, plus the conventionals. Mm-hmm. And then bispecifics will come in as combos- Mm-hmm ... and maybe some other CAR-Ts and ADCs. How are you thinking about those different competitors? Is there anything that's particularly on your radar? And just kind of what's your longer-term outlook for the third-line- Mm-hmm - plus market? Yeah. I think the third line is a big opportunity for CAR-T. I think again, conventional has always been used the best product you have as soon as you can. And so, again, there's a lot of-- As you know, myeloma is an incredibly dynamic development space and constantly, you know, new products being developed, next-gen products being developed. So, you know, we'll see how those play out over time. But again, I think getting physicians and treatment centers comfortable with the product, knowing what to expect, knowing if there is a side effect, how do we handle that side effect? How do we-- That experience with the product can be invaluable commercially and over time. I think, you know, what we can control this year and next year is just that execution, just building the experience with it, delivering, you know, from a supply chain and manufacturing perspective, and building the body of data. You know, that's. There's a lot of focus on cross-trial comparisons, which are fraught. But the real world evidence, and again, this is something we're doing commercially, is encouraging physicians to examine their own history with these different products and, you know, kind of ask questions in terms of what they've seen. I think as we build that body of data, I think that'll be a good thing for Abecma. Mm-hmm. And then any thoughts on just kind of the profile of the bispecific combos in third line? Do you think it'll look kind of similar, relatively speaking, as it has in later lines? Or, do you think CAR-T will kind of maybe- I think it's early to say. You know, we certainly follow them all. I think the one-and-done nature of CAR-T therapy is a powerful thing. It's. We've heard this from patients time and again, and again, the prospect of deep durable responses is real. So, you know, more to come, and, you know, when we have actual pivotal data from some of these combinations, we. I think we can answer that question better. Again, you know, the Myeloma's never been a winner take all kind of market, and so again, we were first to market. We're now, you know, together in this third line setting and, you know, we intend to make the most of it. Mm-hmm. And maybe moving to the financial side a little bit, you guys have guided to significant OpEx cuts over the next two years. How confident are you in your ability to reach that guidance? And then how are you thinking about cash flow positivity? Yeah. Thanks, Matt. We're confident. So just as a reminder, when we announced the sale of our R&D pipeline to Regeneron in late January, we had guided that we expect $150 million of savings in 2024, and $200 million, sorry, of savings in 2025. And the vast majority of that is as a result of the sale of that R&D and savings in R&D. I'd say 80%-90% of that is R&D, so we're confident. In addition to that, we have a very small team now, and so what that means is we can be really focused on efficient capital allocation and making sure that at every turn we're looking at how to be super expeditious with how we're spending money. And then in terms of, you know, a return to growth for Abecma, what do you see as kind of like the threshold for where you reach cash flow positivity, assuming you meet all of the guidance that you've put forth? Yeah. So, we expect cash flow breakeven at the company-wide level as soon as 2025. So that's what we've shared publicly, and we continue to believe that. Sorry. Mm-hmm. And then just speaking of margins with respect to the Abecma business, by itself, what's your outlook there in both the near term and longer term in terms of COGS and also SG&A? Yeah. Thanks, Matt. Over the last 12-18 months, we have seen volatility in COGS, certainly, and readers can see that in our financial statements. I would say that our COGS margin has been about 40%-50% in that last period. I think what a good margin looks like in cell therapy could be anywhere from 65%-80%. And so largely obviously dependent upon the volumes that we see and the return to growth. So we're excited to see improvement as we return to growth here over time. Maybe just in terms of the longer term, maybe overall profit margin, kind of taking out also the SG&A, do you think... Could you give any guidance on that, or is- Um- Is that kind of TBD? Yeah, that's TBD. I mean, we really we're focused on sort of gross margin as a standard metric there, and we haven't really guided to the profit net of SG&A expense. That'll obviously evolve over the next several years as well. Just to add, I think that the SG&A and R&D spend is pretty consistent kind of year-on-year between what we've seen and where we see it headed. So again, to Vicki's point, so long as we can get even modest growth, those margins get better and, you know, we can get to a breakeven stance as a company. So that, you know, we're not guiding specifically what's a precise number, but it's not assuming heroic growth. Mm-hmm. Great. So obviously you guys recently sold off your pipeline to Regeneron. Mm-hmm. They're now leading development of those assets. Could you give us... I I know that they're, from here on out, giving updates, but could you give us an update on where those programs stood at the time that you handed them off, and what the key kind of next data sets are? ... Yeah, I would just say, so, we had sold two phase one assets, so DARIC33 in AML, and, bbT369 in BNHL, and also, MUC16 had just received IND acceptance in the first quarter of 2024. And then the rest of that pipeline was preclinical. And so, as you mentioned, Matt, yourself, I think you should talk to Philip and the Regeneron Cell Medicines team about how that pipeline is progressing. But we're really excited to see where that platform and, and the programs within that platform go in the very capable hands of Regeneron. So now that, you know, obviously, you've handed off that pipeline, and you guys are working on cash flow positivity, how are you thinking about business development and capital allocation? Obviously, you've stated you're solely focused on Abecma business. But could we start to see you guys do other partnerships in terms of, like, scientifically? And then could you bring in maybe other assets later, after you kinda get cash flow inflection? Yeah, no, it's a great question. I think our focus today is to get to as a, as a company, not just as a, on the Abecma collaboration, but overall, all in to get to, to break even, to cash flow positive operations as quickly as we can. And so from here to there, you know, we will continue to be disciplined, not get distracted, not bring new things in. And to Vicki's point, I think that could be, a 2025 event, where we can say on a quarterly basis and moving towards an annual basis, that we're, breaking even, that we're, you know, we're cash flow positive. I think that's a huge proof point in a show me story, kind of, market overall. And it creates strategic optionality for the business. So we get the questions from investors: "Well, what would you do with that cash? Would you, you know, do business development? Would you dividend to shareholders? Would you..." And I think, you know, ask us again when we get there. You know, those are all things we've thought about together with the board, but, you know, the focus is, is clear, again, from here to there, as quickly as we can. And, you know, the two levers is the, the OpEx, which, which Vicki talked about, and which we have, you know, a good amount of control over, and you should start to see evidence of real soon here in the second quarter. And then the revenue growth, which again, I think we'll be able to start to show, in our quarterly, starting in the third quarter. Mm-hmm. And then, do you guys view yourselves as a possible M&A target, or how are you thinking about that aspect? Look, I think having a profitable commercial product in an innovative space like cell therapy is pretty rare and pretty valuable. So, again, I think our focus is to get to cash flow break even and positive, and I think that creates all sorts of strategic options, including M&A. And so... But again, we have to deliver some things here in 2024. I think five months in, we've delivered what we hoped to, and you know, the next couple quarters are gonna be pretty telling on that front. Mm-hmm. And then maybe moving to the BMS partnership. Mm-hmm. Could you guys speak to the current status of that partnership and where they stand on the outlook for Abecma? And then are they fully committed to this asset, just kind of given the transition that it's in right now? Mm-hmm. Do you think they would actually have any interest in fully owning Abecma? Yeah, I can comment on some, probably not all of that, but I would say it, at an alliance management level, at a senior leadership level, it's a terrific partnership. It's a terrific collaboration, and candidly, we could have never moved Abecma as far as we had on our own. You need the throw weight and the scale of a company like BMS to really deliver in cell therapy, commercially and from a manufacturer perspective. So on those fronts, they've been terrific partners. And you know, when you look at the looming LOE that you know, all pharmas are dealing with, BMS as well, you have to look for growth opportunities. You know, we've heard them say, and it seems pretty clear, that cell therapy is a key pillar as they think about the second half of the decade. Myeloma has been a huge long-term franchise for them, you know, dating back to even the Celgene acquisition and prior. So all those things position Abecma very well as being a very important commercial asset for them. You know, I think practically, we've seen them putting some of their best resources against Abecma in terms of commercial leadership, in terms of the team, the sales force, the MSLs, heads of manufacturing. All of those things are investments they're making, even the recent collaboration with Cellares to look at next gen manufacturing. They're investing in Abecma, Breyanzi, but also the pipeline behind it. So we feel like the commitment to cell therapy is real, the commitment to Abecma and the myeloma space is real, and, you know, we have confidence in their plan and what they're doing to deliver. It's harder to say, you know, what are they... Their long-term corporate development questions is, you know, it's a good question for their- Mm-hmm. - corp dev team. Mm-hmm. Yeah. Great. Well, maybe just to wrap up, you know, how should we look at the catalyst outlook from here until, you know, year-end? And is there anything else that you guys wanna highlight? Yeah, I mean, as I said, I think it's really clear what we're gonna see in the second quarter, which is a, you know, reduction in OpEx. And then starting in the third quarter, we'll get a sense of that return to growth. So, you know, we've said it, but I, you know, sometimes you have to say things five or six times, but the second quarter, you know, it's not, we're not pointing to as a big breakout quarter just yet. It's kind of what comes after that, and again, we're doing all the right things. BMS is doing all the right things to help drive that. You know, I think the revenue growth in the second half will start to teach us what that trajectory is. Our focus really is, you know, where, where do we end up at the end of the year? What, what is the exit trajectory as we head into 2025? Again, this is a product that a year ago did $118 million in the first quarter, so we know we can be at levels that are far higher than where we're at today. We can manufacture to those levels, and again, now we've got a much bigger opportunity, with the better data set to go after those patients. So we're excited about the future, and we've got the time to play it out and, I think the resolve to do it, so. Mm-hmm. Great. Yeah. Well, Chip, Vicki, thank you guys very much. Mm-hmm. Appreciate you guys coming here today. Yeah. Thanks, Matt. Thanks for having us.
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