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On Wednesday, 21 May 2025, ADC Therapeutics (NYSE:ADCT) presented at the RBC Capital Markets Global Healthcare Conference 2025. CEO Amit Malik outlined both the promising prospects and challenges for the company’s lead product, ZIMMANTA, in treating DLBCL and indolent lymphomas. The discussion centered on market share expansion, upcoming trial data, and strategic financial planning.
Key Takeaways
- ADC Therapeutics aims for ZIMMANTA to reach peak US sales between $600 million and $1 billion.
- The company ended Q1 2024 with $196 million in cash, extending its runway into the second half of 2026.
- ZIMMANTA currently holds a 10% market share in the third-line plus DLBCL setting.
- Upcoming LOTUS-5 and LOTUS-7 trial data are expected to significantly impact future growth.
Financial Results
- Q1 2024 Cash Position:
- ADC Therapeutics reported $196 million in cash.
- Cash Runway:
- Funds are expected to last until the second half of 2026.
- Net Cash Burn:
- The company burns $30-35 million quarterly, with $10 million allocated to the LOTUS-5 trial and another $10 million to research expenses.
- Peak Sales Potential:
- ZIMMANTA’s US sales could peak at $600 million to $1 billion, pending successful market expansion.
Operational Updates
- ZIMMANTA Market Share:
- Holds a 10% share in third-line plus DLBCL therapies.
- LOTUS-5 Trial:
- Completed enrollment, with results expected by end-2024 or early 2025.
- LOTUS-7 Trial:
- Completed dose expansion with 40 patients; further data to be presented at EHA and ICML.
- Indolent Lymphoma Studies:
- Ongoing Phase 2 IITs in follicular and marginal zone lymphoma.
- Solid Tumor Pipeline:
- Advancing exatecan-based ADCs, with one program moving through IND this year.
Future Outlook
- Growth Trajectory:
- Significant growth anticipated starting in early 2027, driven by LOTUS trials and indolent lymphoma expansion.
- Regulatory Strategy:
- Plans to engage with the FDA in late 2024 for ZIMMANTA’s phase 3 designs.
- Partnership Strategy:
- Actively seeking collaborations to advance the solid tumor pipeline.
Q&A Highlights
- Population Enrollment:
- LOTUS-5 has less Asian enrollment; LOTUS-7 is primarily US-based.
- Combination Therapies:
- LOTUS-5 combines ZIMMANTA with rituximab, showing promising efficacy.
For more detailed insights, readers are encouraged to refer to the full transcript.
Full transcript - RBC Capital Markets Global Healthcare Conference 2025:
Greg Renza, Biotech Analyst, RBC: Everyone to the twenty twenty five RBC Global Healthcare Conference. My name is Greg Renza, one of the biotech analysts here at RBC, and we’re pleased to be joined by ADC Therapeutics, just just now and joining us from the company. In addition to the to the full team, of course, we have representing ADC, Amit Malik, chief executive officer. Amit, great great to see you. Look forward to to a discussion.
A great deal going on in the space. A great deal going on with with Zinlanta, certainly with EHA coming up with recently reporting earnings and and seeing the the trajectory of Zinlanta in the market today. And maybe the way we can get started is for those less acquainted with ADC Therapeutics, just have you give a brief intro to the company.
Amit Malik, Chief Executive Officer, ADC Therapeutics: Sure. Well, thanks, Craig. I appreciate the opportunity. So ADC Therapeutics is an antibody drug conjugate company. We have end to end capabilities from research through commercialization, and our strategy is really focused on two different pillars.
The first is on ZIMMANTA, which is our commercialized product, where we have multiple different studies to expand the use into earlier lines of DLBCL as well as into indolimphomas. And our second pillar, which is an early stage solid tumor pipeline, the most advanced of which is exoticon based programs, in particular those targeting PSMA and qualms to the most advanced.
Greg Renza, Biotech Analyst, RBC: Fantastic. Maybe a good way to do this is just to have you maybe share some of the updates about how Zalanta is doing in the market with the recent disclosures just last week, and maybe setting, you know, some context for the performance in late line DLBCL, and then we’ll go on to the data and the updates that are coming.
Amit Malik, Chief Executive Officer, ADC Therapeutics: Sure. Yeah, maybe just to give a little context. When you move into that relapsedrefractory setting within DLBCL, the market really kind of segments into two broad categories. The first is more complex therapies that require specialized infrastructure, expertise, and patient management. These are cellular therapies and bispecific based therapies, which have very high efficacy, but not every physician is able to administer them.
And then you have broadly accessible therapies like ADCs and chemotherapy, which can really be administered by any sort of physician, including in the community setting, and really diversely almost any patient. So those are the two segments of our strategy. Right now, we’re approved via the accelerated approval pathway as a monotherapy in the third line plus setting. Just to give you context between those two segments, the cellular therapies and bispecifics have about 60% of that third line plus setting. The more broadly accessible therapies have about 40%.
We have about 10% market share, so meaning 25% of that 40% is what we’re doing. I feel very pleased about our performance because we’ve been able to maintain that despite bispecifics were only launched about two years ago, have taken over about a third of the market. And so that segment, which is about 25% of complex therapies, has grown to 60%, and yet we’ve maintained a roughly 10% share. So we’ve been able to gain ground in in new centers and with new patient groups, so I feel good about that, but even more excited about what’s coming next in terms of further studies.
Greg Renza, Biotech Analyst, RBC: Yeah, absolutely. And maybe just following up here, when it comes to the community versus the academic setting and just the potential untapped market there, the impact of CAR Ts and bispecifics that you’ve alluded to. How is that evolving? I know even in ODAC yesterday, which I’d love to get your views on several moving parts. Just walk us through the sort of ADC perspective.
Amit Malik, Chief Executive Officer, ADC Therapeutics: Sure. So as I mentioned, if you look at the dynamics, I mean, frontline hasn’t changed very much over the last several decades. Really, our CHOP has been the mainstay. The one, of course, change that’s happened over the last couple of years is that pull of the R CHOP got approved. About a third of the patients frontline get that therapy.
That’s been the one advancement. Frontline’s a very high bar, obviously, because more than sixty percent of patients get cured in that frontline setting with the existing standard of care. So the bar is extremely high. Once you move into second line, CAR Ts make up about twenty percent of the therapies. And right now, bispecific combinations are in the guidelines, but none have yet been approved.
And so the really the majority of that market is the broadly accessible therapies like ADCs and monoclonal antibodies and and chemotherapies. Once you move to the third third line setting, and plus, you have CAR T transplant, and bispecifics taking about 60% of the market, and then broadly accessible therapies like us and chemotherapy taking up the remaining 40% of the market. What I’m excited about is that we really can play in both segments extremely well. So we have a strategy with a confirmatory phase three study, which is combining ZINLANTA plus rituximab. Our base therapies are the most commonly used amongst those broadly accessible therapies.
We’ve already completed enrollment of the study. We expect to hit the prespecified PFS events by the end of this year, and then hop to have top line results either end of this year or early next year, depending on when we get the events. In that segment, we’ve already shown in the first twenty patients in our safety run-in, we’ve shown efficacy data, which is an eighty percent overall response rate, a fifty percent CR rate, and with manageable safety profile, we’re gonna be presenting data, so the abstracts are out at EHA, where the median duration response for the CRs wasn’t reached even two years later. That’s similar to what we saw with the monotherapy. So it’s very durable when you get into CR we’ve seen with ZIMMANTA.
On the other hand, for the more complex therapies, we believe we have the opportunity to have the best in class bispecific combination therapy. We have a collaboration with Roche studying ZIMMANTA plus glafitamab, where we’ve seen unprecedented efficacy. Recently, there was an abstract that we published that was shared that’s going to be presented at both EHA and ICML, showing an overall response rate of over ninety five percent and a CR rate of ninety one percent across the first twenty two evaluable patients. This is the dose expansion of Xelanta. We’ve now completed 40 patients in the dose expansion, and we plan to share a larger dataset with much longer follow-up at EHA and then also at ICML.
Of course, in that analysis, there’ll be a lot more data than what’s seen in the abstract. To note, I would say also in our studies, especially because you asked about ODAC, and and there was obviously a lot around the Asian versus non Asian population just to address that head on. We don’t go into specifics, obviously, for ongoing randomized phase three studies, because getting into patient characteristics baseline characteristics without efficacy doesn’t really make sense. I mean, we we present all that together. What I can say with our LOTUS five study, though, is we have significantly less Asian enrollment in our study, and a much larger study.
So we have a 420 patient randomized study, one to one randomization. So there’s a lot of differences in the profile, I think, of the study design as well as in the population. LOTUS seven, which is the data I mentioned that has a ninety one percent complete response rate, is entirely enrolled in The US and Europe, the majority of which is in The US.
Greg Renza, Biotech Analyst, RBC: Excellent. Excellent. And then as as far as taking the the LOTUS data, the LOTUS seven seven data, just just talk about the the potential anticipation of the next steps, the the the FDA engagement just after this data and the next steps there?
Amit Malik, Chief Executive Officer, ADC Therapeutics: Yeah, I mean, we’re really excited about the data, because when you look at all the bispecific combination studies that have read out anywhere from phase one studies through phase three, the CR rates, which we know is a very good predictability of durability, have all been in the range of forty seven percent to sixty two percent. So that’s the range. CAR Ts, of course, are a bit above that. You see that them them ranging in kind of the mid sixties to the low seventies in terms of CR rate. So for us, if we were even in the mid sixties, it’d be highly differentiated.
We thought if we could get above seventy percent CR rate, you clearly become the best in class efficacy agent amongst the bispecific combinations. So to see ninety one percent in our first twenty two patients is obviously outstanding data. The way we plan to move forward is twofold. One is we’re assessing options now to expand our at the at at our selected dose to a hundred patients. We know that about a hundred patients is what’s allowed three different bispecific combinations to get preferred and NCCN guidelines.
Mhmm. We think we could have that enrolled, you know, pending the funding by early next year or certainly in the first half of next year, and then and then, you know, be able to share that data with a with a year of follow-up and and potentially get into guidelines as soon as 2027. And then when you look at the regulatory side, now that we have the dose expansion, all 40 patients completed, we’re waiting for the scans of that. We plan to engage with the FDA in the second half of the year Mhmm. On the dose selection as well as potential phase three designs.
Gotcha. Okay.
Greg Renza, Biotech Analyst, RBC: Alright. Very good. And then as as you quote some base assumptions about the commercial opportunity, 2 to 2 to 300,000,000 in in the LOTUS five area, a lot of nice layers, may maybe just help us break down the understanding of of of how that works, how it translates to the value for the company.
Amit Malik, Chief Executive Officer, ADC Therapeutics: Sure. So you start with, in the third line setting, you’re about 6,000 patients. When you move to second line, you go to 12,000 patients. So you double the population by moving to the second line setting. In addition, we know that our duration of therapy right now in third line plus as a monotherapy is about three cycles.
When you get to second line, we’re seeing on average five to six cycles. You’re gonna see double the population with much longer durability and, of course, a better clinical profile because what we’ve seen as a monotherapy is CR rates of roughly twenty five percent. What we’ve seen in the safety of running for LOTUS five is fifty percent, and we’ve seen over ninety percent with LOTUS seven. So clearly, much better clinical profile in a larger patient population with a longer duration of therapy. So even if you were just to take the LOTUS five, for example, our roughly ten percent share that we see in the third line setting, even if we were just to maintain that share, you get well over $200,000,000 Right.
Obviously, with some improvement in share, given you have a much better clinical profile, we get to 2 to $300,000,000 opportunity versus our roughly $70,000,000 in sales that we have in the third line setting. With LOTUS seven, because we do think that bispecifics combinations have the potential to be the largest segment in that second line plus setting, we believe we have a chance to play a leadership role that could bring the total opportunity for ZIMMANTA, inclusive of LOTUS five and our current indication, to five to eight hundred million dollars. Beyond that, we also have additional opportunities in endo lymphomas, which could add even further
Greg Renza, Biotech Analyst, RBC: Yeah.
Amit Malik, Chief Executive Officer, ADC Therapeutics: To to the potential of ZIMMANTA. So we think there’s a lot of opportunity for growth. And really, over the next, you know, several months, we’re gonna have a lot of data derisking events, which allow for us to start, we think, a much more significant growth trajectory starting in early twenty twenty seven.
Greg Renza, Biotech Analyst, RBC: And with the other other indications in the expansion, maybe just recap a little bit the the ASH data in follicular and marginal zone, just take home message there. What should we expect to see next, and how much of a priority is that as far as the expansion equation?
Amit Malik, Chief Executive Officer, ADC Therapeutics: Yeah. So we have two different phase two IITs. One is looking at the relapsed refractory high risk follicular lymphoma patient population. In the first thirty nine evaluable patients at at ASH, the investigator presented seventy seven percent complete response rate. It’s a very robust complete response rate, especially in the population where these weren’t only high risk patients, but more than half of which were POD24.
So it’s a pretty tough to treat patient population. We know that follicular is much more competitive. There’s a lot of phase three studies, but we think we may have an opportunity. We’ve already gone into NCCN guidelines with actually that patient data in the nonpreferred status, but we think with the 100 patient study, we have the opportunity potentially to get in preferred, especially for the patient patients that can benefit the most, which are these high risk patients. We’ll also consider different regulatory strategies for FL as well.
For marginal zone lymphoma, that’s a much it’s it’s a much rarer population. There’s only three to four thousand relapsed refractory MZL patients in The US, and there haven’t been any randomized purely MZL studies ever conducted. So when you look at the there’s been two approvals and two additional regimens in the guidelines, mostly the BTK inhibitors dominate this space. They’ve all been based on anywhere from thirty six to sixty eight patients, and there hasn’t been a CR rate more than twenty nine percent. The ASH data, which is in the first twenty three patients of a 50 patient study, showed a CR rate of seventy percent, and with a manageable safety profile.
So the profile looks really interesting. Based on the study, we plan to engage with the FDA and other regulatory authorities on a potential approval based on the study, but also, we’ll, of course, submit to NCCN guidelines. Just to give you a sense of how big the MZL opportunity is, you know, the the total theoretical market opportunity, if you add three to 4,000 patients times the five to six cycles of ZENLATA that you get times our net price, that’s a total market opportunity of $500,000,000 in peak sales. So for every 10% share that we’re able to achieve, if we’re successful, that would translate into roughly $50,000,000 Mhmm. Per year additionally, just for every 10% share.
So I think Marshall Zone’s an additionally good opportunity in particular. And follicular will be a little bit tougher because of the competitive landscape, but we think there’s a potential opportunity at least in those high risk patient populations. Great.
Greg Renza, Biotech Analyst, RBC: Great. And, yes, 2025 is certainly a year for for for news and data points, we never want to overlook the the the pipeline of meat. So maybe we can talk a little bit about the pipeline evolution, solid tumors, the next gen ADCs that you that you’re contemplating taking forward and how that fits into the to the broader scheme of your strategy.
Amit Malik, Chief Executive Officer, ADC Therapeutics: Yeah. So I mean, we’ve really been focused. The most advanced part of our portfolio is really focused on exatecan based ADCs, focusing on, I think, some pretty big solid tumor targets, the two most advanced of which are PSMA and Claudine six. We’re going to be moving one of those through IND this year. We haven’t disclosed which one.
And the strategy has been, from a capital allocation standpoint, we’re investing really the majority of our money against Emanta because we see a near term opportunity to really get to a significant growth trajectory and even get to market independence at some point for the company. So on the solid tumor side, we are investing to a point, but but investment, particularly when we get to the clinical stage, will depend on collaborations and partnerships. And we’re in a number of different discussions around that as we speak.
Greg Renza, Biotech Analyst, RBC: That’s great. And you mentioned market independence, so it’s appropriate to to ask about what not just the capital allocation, what you’re allocating, maybe your cash position, and and how it diffuses to the rest of the organization.
Amit Malik, Chief Executive Officer, ADC Therapeutics: Yeah. So we ended q one with a hundred $96,000,000 in cash. That gives us a cash runway until the second half into the second half of twenty twenty six. Now a couple things to note that are important. So we burn, you know, anywhere from 30 to 30 5 million on average per quarter net.
That’s after sales. So net that’s our net kind of cash burn. But close to 10,000,000 of that is Lotus five, which we know is finished enrolling. We’re still seeing costs because you have a lot of patients in the study. But as we get into that second half of twenty twenty six, obviously, those costs start to go away.
And then we have another roughly 10,000,000, which is in our research expense, which is, mentioned before, a lot of that future funding will depend on a potential partnership or collaboration. So if we think of what what the needs will be, especially as 2027 starts a growth trajectory with multiple different growth opportunities that I mentioned with LOTUS five or LOTUS seven, potentially even with indolent lymphomas, the pathway towards market independence starts to become clear, you know, over the course of that period of time.
Greg Renza, Biotech Analyst, RBC: And you’ve mentioned partnerships with in with future collaborations and and future assets. What does an optimal partnership look like? How do you think about the decision tree for an ideal partner to move forward in advancing one of the assets?
Amit Malik, Chief Executive Officer, ADC Therapeutics: I think we’re open to the different structures. I think the key thing is we have multiple assets to move forward. As you know, to do things properly, take real money. Some of these require biomarker analysis. They they can involve multiple solid tumors.
Not only it’s, you know, as a single agent, but also in combination. You know, we think about PSMA, for example, the potential to combine with ARIs or, you know, when when it comes to clon-six and potentially combine with platinum. So the to do these studies and to really investigate the the total cost takes takes takes some real money. So that’s why we think when you get into solid tumors, partnering, especially when you get to that clinical stage, is a way for us to unlock more value and to and to have more shots on goal. The the way the collaboration restructure, I think we’re open to that.
Great.
Greg Renza, Biotech Analyst, RBC: Great. So in the last moments, I wanna see if the the audience in New York here has any any questions.
Amit Malik, Chief Executive Officer, ADC Therapeutics: Don’t know.
Greg Renza, Biotech Analyst, RBC: Dan, any any closing remarks before we break?
Amit Malik, Chief Executive Officer, ADC Therapeutics: Yeah, no, would just say, well, first of all, thanks for the opportunity. As I said, you know, within our core focus as Enlanta, we believe we have a tremendous opportunity. We’re moving from a small indication of third line plus, where we have monotherapy efficacy of roughly twenty five percent CR, to an environment where we can move into earlier lines of therapy with what we’ve seen so far in our early safety run-in, fifty percent CR with LOTUS five combined with rituximab, or an over ninety percent CR rate combined with glufetamab in the LOTUS seven setting. We think these opportunities combined with the potential opportunities with indolent lymphomas can bring this drug to a 600,000,000 to a billion dollar peak sales opportunity in The US. We have global partners as well where we benefit from milestones and royalties, which is further upside, especially as time goes on.
And because of where our cash runway is, we don’t need so much more to get us to that point where we get into the growth stage and then get eventually towards market independence. So we’re excited about the opportunity. We think we have a lot of exciting data, particularly this year. It will be a big data derisking year Mhmm. To set us up for what we think could be a really big growth trajectory starting in early twenty twenty seven.
Greg Renza, Biotech Analyst, RBC: It’s great. Well, thank you so much. Great to see you, and look look forward to to EHA and and all the updates this year.
Amit Malik, Chief Executive Officer, ADC Therapeutics: Yeah. Thank you very much, Greg.
Greg Renza, Biotech Analyst, RBC: Appreciate it. Thanks, everyone. Thanks, Steve.
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