ADC Therapeutics S.A. Q3 FY2025 earnings call

• CEO Ameet Mallik discussed focusing on execution, ZENLATA's performance with net revenues $15.8M, progress on key trials (LOTUS V, LOTUS VII), IND enabling for PSMA ADC, and $60M private placement strengthening cash runway to 2028. • CMO Mohamed Zaki shared updated Phase II IIT data for ZENLATA in relapsed/refractory follicular lymphoma with 98.2% overall response rate and 83.6% complete response rate. • CFO Pepe Carmona reviewed financial results: net loss decreased, cash and cash equivalents $234.7M at quarter end, $60M PIPE financing strengthening balance sheet, and data catalysts in 2025-2026 for LOTUS V, LOTUS VII, and MZL ZENLATA programs.

Net product revenues were $15.8 million in the third quarter. ZENLATA is the key product, with net product revenues reflecting variability in customer ordering patterns. In indolent lymphomas, the Phase II IIT of ZENLATA in combination with rituximab for relapsed or refractory follicular lymphoma showed encouraging data, and the Phase II IIT in relapsed or refractory marginal zone lymphoma continues enrolling. The PSMA targeting ADC's IND enabling activities are on track to complete by year-end.

• Expect data catalysts in LOTUS V, LOTUS VII, and MZL ZENLATA programs in remainder of 2025 and 2026. • LOTUS V expected to provide top-line results in 2026 once prespecified PFS events reached. • LOTUS VII to provide clinical update on efficacy evaluable patients with min 6 months follow-up before end of 2025. • Cash runway extended to at least 2028 with $60M private placement.

• Forward-looking statements subject to known and unknown risks and uncertainties, actual results may differ materially. • Non-GAAP measures should be considered in addition to GAAP.

Q: Maybe I'm intrigued by Pepe's comments that we're seeing accelerated enrollment post the June data release. Not surprising, of course, but can you frame how many patients we might get later this quarter? And then in terms of your target enrollment, out of 100 or so patients, are you adjusting that target? And is it possible that that target could be reached sooner rather than later?

A: Thanks for the question, Eric. Yeah, no. We've been pleased that since the EHA and ICML update, we've had even greater interest in the trial, and enrollment has definitely accelerated. We're still targeting the roughly 100 patients that we've been targeting to enroll. It will occur quicker than when we originally anticipated. We're not giving an exact timeline, but we're still confirming the first half of next year to have that completed. And then in terms of the upcoming data release, are you still targeting 40 or forty plus? Well, we'll give you know, as you recall, we had enrolled originally twenty patients in each dose, then we continue to expand at the 150 dose, right? So it'll clearly be more than the original twenty and twenty. But it won't be fully all 100. And, also, I want to make sure you heard what Pepe said is that we're going to be sharing updates on all efficacy evaluable patients with a minimum six months follow-up. This is because it provides more stable, meaningful updates, both in terms of the depth of the response but also the durability of response. That was, as you can recall, some of the questions we received in the early updates is we had very limited follow-up. So now we're focused on where the data is more stable, and that's really when patients with a minimum six-month follow-up.

Q: Hi, good morning. Thanks for taking our questions. This is Jenna Li on the line. Could you talk about in the context of the upcoming LOTUS V and LOTUS VII data and the submission timelines, when should we expect to see an inflection point for ZENLATA sales? And could you also give some qualitative comments on the pace of revenue ramp-up once you have those potentially positive data or approval in hand?

A: Yes. I think you're asking about the milestones and then also the revenue inflection. So first, I would say, for LOTUS VII, we expect to share an interim update on data later this year. And, obviously, we expect to have full data sometime by the end of next year or into 2027. As you can see, what we guided to is publication and or compendia inclusion sometime between the end of next year and 2027. With LOTUS V, we expect to share top-line results in 2026, and then have approval sometime in 2027. So if you didn't get the revenue ramp-up for those two following compendia inclusion and approvals, which we expect for both, the first half of 2027, we expect revenues to ramp up subsequent to that.

Q: Hey. This is Sarah on for Michael. Thanks so much for taking my question. So I just wanted to get your thoughts on with these newer agents moving into frontline DLBCL, is that something that you are or would consider pursuing for ZENLATA?

A: Yeah. No. I think the frontline will be because if you look at the frontline setting, for decades, really, R-CHOP was the standard of care. Then only a couple of years ago, saw 0.1 of the biggest things being studied right now are bispecifics. I think there's some excitement about if those could have potential still to be determined, I think, still a little bit of ways away from seeing those readouts. And in terms of our future development, we'll consider how that goes for this combination post the readout of 100 patients and any support would depend on a partner too. I don't see us likely funding a phase three study with this in the frontline or the second-line setting with this combination purely on our own.

Q: Hey, thanks for taking my question. I just want to ask on sort of the split of community and academic. I know you've talked about LOTUS V potentially being more positioned in the broadly applicable therapies and LOTUS VII more for the academic. But I guess I'm curious how neat you think those breakdowns actually are going to be and sort of how you're going to balance ultimately where patients are found and how you want to focus your sales force across academic and community to sort of pursue the opportunity where it is.

A: Yeah. So I would I wouldn't do the breakdown in terms of academic community. What I'd say is for the more complex therapies, whether it's CAR T or bispecifics, so let's just talk about bispecifics because that's more applicable to LOTUS VII. They're not only used across all the academic subjects. They are used in more sophisticated community centers, and that may grow over time. So I wouldn't say the distinction is purely community versus academic. It's more of all of the academic can administer those products. And a portion of the community can administer those products. In that universe of institutions that can administer the product, obviously LOTUS VII is going to have a place. Then there's other therapies, like chemotherapy, ADCs, antibodies, which are more broadly accessible, and those can be administered across all settings. But they are still administered in the academic centers, and they're administered in all the community settings. So I wouldn't differentiate to say LOTUS VII is going to be purely academic and LOTUS V is going to be purely community. The reality is LOTUS VII, when a patient is suitable for it, and if the facility can administer the therapy, you're going to go with the highest efficacy product and combination that you can go with. We think LOTUS VII is really well positioned, and that will be used, again, in all the academic centers and a portion of the community. Exactly how much, we'll see over time how bispecifics are adopted by the community. With LOTUS V, either because of accessibility of the therapy or because of suitability for the patient, remember, there's some patients that have comorbidities or other conditions which may prevent them from getting an immune-based therapy. It may be a post-CAR T patient that's at risk of infection. It may be a patient with autoimmune disease. There may be other reasons why you're not going to want to give a bispecific-based therapy. And for other centers in the community, they're not going to have access to them. So for all those reasons, we think LOTUS V still plays a big role. We still see our base chemo regimens having a large share in the relapsed refractory market. So we think we have a good place, and that's really our strategy, to hopefully have leading efficacy in both of these segments, both the complex therapies and the more broadly accessible therapies.

Q: Hey, good morning Ameet, Mohamed, and Pepe. I know you've spoken about the opportunity in the second line, third line plus for relapsed refractory DLBCL with LOTUS VII, LOTUS V outcomes respectively. But can you give us more details on how you view each percentage increase in penetration in either the second or third line setting would add to the ZENLATA revenues to achieve your peak guidance ranges that you've noted? And then secondly, regarding the ZENLATA plus rituximab, for relapsed/refractory FL, data thus far at 84% CR rate seems to slide in nicely right after the T cell therapeutics. And then in line are slightly better than the bispecific. If this holds true, does this mostly take market share away from bispecifics or any opportunity to take from the T cell therapeutic options in FL?

A: Yeah. So I would say, you know, to answer your first about what's SharePoint worth, so think about in the second line setting, there's about twelve thousand patients in the U.S. And in the third line plus setting, there's six thousand patients. So depending on where you're getting the share, is it second line setting or third line plus every share point, obviously, multiplied by the number of patients. With monotherapy, we're typically seeing three cycles. Now remember, the first two doses of our product are 150 micrograms per kilogram, then it drops to 75. So it's weight-based, but oftentimes it could be two vials for the first two cycles and drop to one vial. What we're seeing with LOTUS V and LOTUS VII is somewhere between five to six cycles. So you can just do the subsequent calculation on vials. And then you know what our net price and our gross price is in the upper twenties, thousands. Net price is in the lower 20,000. So if you do the kind of calculation depending on what if you're talking about a SharePoint, the second line, a third line plus setting, that kind of gives you a rough estimate. Just by way of example, like in the LOTUS V, for example, if we were able to maintain our roughly 10% share that we have in the third line plus setting and translate that in the second line setting. But with increased duration of therapy in our net pricing, that would take our product, which is on a roughly $70 million run rate, what it's kind of been the last couple of years. To just over $200 million. Obviously, we were hoping with efficacy improvements, you actually gain share, and that's what leads to the guidance of $200 to $300 million. You can do similar calculations for LOTUS VII. Now turning to the indolent lymphomas. I think we're excited both about the data that Mohamed spoke about with the last refractory follicular lymphoma. And relapsed/refractory marginal zone lymphoma data that was presented at EHA and ICML. I think both right now are showing outstanding results. I would say in terms of the opportunity for potential adoption, right now we're basically funded to try to get into compendia for both. So obviously, we won't promote either of these indications. But what I could say is the unmet need and the level of competition is probably higher. Unmet need is higher in MZL, and the level of competition is lower in MZL versus follicular lymphoma. That's why we've emphasized that one a bit more. When you look at the different agents that are approved during compendia, the FCR rates are 29%, roughly 30%. Even if you look at subsequent data that's come out, maybe a bit higher than that, what we've been showing is closer to 70% CR rate in that MZL setting. In follicular, although the data is outstanding, and we hope to have a place there, it's a lot more competitive. There's literally more than 10 agents that have phase three trials including the bispecifics, and many other agents, who have large phase three studies with overall survival. And it's just a more competitive space. That's why we think the potential for uptake is just smaller, not because the data isn't excellent, but just because it's a much more competitive space.