ADC Therapeutics FY2025 Q3 Earnings Call Summary and Q&A Highlights: Clinical Progress and Strategic Financial Moves
Earnings Call
Nov 10
[Management View] Net Product Revenue: $15.8 million for the quarter, down from $18 million in the same period in 2024. Operating Expenses: $45 million (non-GAAP), a 12.1% decrease, primarily driven by lower R&D costs. Net Loss (GAAP): $41 million, or $0.30 per share, compared to $44 million, or $0.42 per share, a year earlier. Cash Position: $234.7 million at quarter end, with pro forma cash of $292.3 million after a $60 million private placement completed in October. ZYNLONTA (ZENLATA) Clinical Progress: Phase III LOTUS V trial continues enrollment, with top-line results expected in 2026.
[Outlook] Performance guidance: Projected peak annual revenue expansion to $200 million–$800 million across DLBCL settings contingent on successful clinical outcomes and regulatory milestones. Future plans: IND-enabling activities for a PSMA-targeted ADC are on track for completion by year-end.
[Financial Performance] YoY/QoQ trends: Net product revenue declined YoY, while operating expenses decreased by 12.1%. Net loss moderated due to reduced R&D and G&A expenses.
[Q&A Highlights] Question 1: Maybe I am intrigued by Pepe's comments that we are 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 target could be sooner rather than later? Thank you. Answer: Thanks for the question, Eric. Yeah. No. We have been pleased that since the EHA and ICML update, we have had even greater interest in the trial, and enrollment has definitely accelerated. We are still targeting the roughly 100 patients that we have been targeting to enroll. It will occur quicker than when we originally anticipated. We are not giving you an exact timeline. We are still confirming the first half of next year to have that completed. And then in terms of the upcoming data release, Amit, are you still targeting 40 or forty plus? Well, we will 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 will clearly be more than the original twenty and twenty. But it will not be fully all 100. And, also, I want to make sure you heard what Pepe said is that we are 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 are focused on where the data is more stable, and that is really when patients with a minimum six-month follow-up. Okay. Thank you very much.
Question 2: 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? Thank you so much. Answer: Yes. I think you are 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 did not 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. Jenna Li: So sorry. Just a quick follow-up. Did you also have any comments on the pace of ramp-up following, each first half of 2027? Ameet Mallik: Yeah. I mean, I do not want to guide to the exact ramp-up. What I will say is if you look at other launches, whether it is the bispecifics or Polivy in frontline or others. I would say the majority of the ramp-up happens during the first two years post-launch or approval or compendia listing of a new indication. It is typically the majority that is going to happen in the first two years. Jenna Li: That is super helpful. Thank you so much.
Question 3: 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? Thanks so much. Answer: 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 is 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 will consider how that goes for this combination post the readout of 100 patients and any support would depend on a partner too. I do not 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. Sarah: Thanks so much. Ameet Mallik: Yeah. We are watching the space closely.
Question 4: Hey, thanks for taking my question. I just want to ask on sort of the split of community and academic. I know you have talked about LOTUS V potentially being more positioned in the broadly applicable therapies and LOTUS VII more for the academic. But I guess I am curious how neat you think those breakdowns actually are going to be and sort of how you are 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. Thanks. Answer: Yeah. So I would not do the breakdown in terms of academic community. What I would say is for the more complex therapies, whether it is CAR T or bispecifics, so let us just talk about bispecifics because that is more applicable to LOTUS VII. They are not only used across all the academic subjects. They are used in more sophisticated community centers, and that may grow over time. So I would not say the distinction is purely community versus academic. It is 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 are 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 are administered in all the community settings. So I would not 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 the facility can administer the therapy, you are 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 will 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 are 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 is at risk of infection. It may be a patient with autoimmune disease. There may be other reasons why you are not going to want to give a bispecific-based therapy. And for other centers in the community, they are 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 is really our strategy, to hopefully have leading efficacy in both of these segments, both the complex therapies and the more broadly accessible therapies.
Question 5: Hey, good morning, Ameet, Mohamed, and Pepe. I know you have 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 have 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? Glad to get your details on those things. Thanks. Answer: Yeah. So I would say, you know, to answer your first about what SharePoint is worth, so think about in the second line setting, there are about twelve thousand patients in the U.S. And in the third line plus setting, there are six thousand patients. So depending on where you are 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 are 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 is weight-based, but oftentimes it could be two vials for the first two cycles and drop to one vial. What we are 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 are 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 has 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 is 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 are 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 IC. I think both right now are showing outstanding results. I would say in terms of the opportunity for potential adoption, right now we are basically funded to try to get into compendia for both. So obviously, we will not 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 is why we have 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 has come out, maybe a bit higher than that, what we have 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 is a lot more competitive. There are 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 is just a more competitive space. That is why we think the potential for uptake is just smaller, not because the data is not excellent, but just because it is a much more competitive space.
[Sentiment Analysis] Tone of analysts: Generally positive, with interest in clinical progress and financial stability. Tone of management: Confident and optimistic about future growth and clinical outcomes.
[Quarterly Comparison] | Key Metrics | Q3 2025 | Q3 2024 | |------------------------|---------------|---------------| | Net Product Revenue | $15.8 million | $18 million | | Operating Expenses | $45 million | $51.2 million | | Net Loss (GAAP) | $41 million | $44 million | | Cash Position | $234.7 million| $250.9 million|
[Risks and Concerns] - Variability in customer ordering patterns affecting revenue stability. - Dependence on successful clinical outcomes and regulatory approvals for future revenue growth. - Competitive landscape in indolent lymphomas, particularly follicular lymphoma.
[Final Takeaway] ADC Therapeutics reported a year-over-year decline in net product revenue and a moderation in GAAP net loss, supported by operational cost reduction and disciplined capital allocation. Management highlighted ongoing clinical advancement for ZENLATA across multiple trials, emphasizing recent efficacy data updates and planned regulatory disclosures through 2026–2027. The company secured a significant private placement after quarter-end, substantially extending its liquidity horizon and enabling continued investment in both flagship and pipeline assets. The outlook remains positive, contingent on successful clinical outcomes and regulatory milestones.
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