ADC Therapeutics SA

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q2 2026 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, August 13, 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Operator. Today we issued a press release announcing our second quarter 2026 financial results and business updates. This release and the slides we will use in today's presentation are available on the investor section of the ADC Therapeutics website. I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, who will discuss our operational performance and recent business highlights, followed by our Chief Medical Officer, Mohamed Zaki, who will provide clinical and regulatory updates, and lastly, our Chief Financial Officer, Pepe Carmona, who will review our second quarter 2026 financial results. We will then open the call to questions. Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance, and achievements could differ materially. They are identified and described in the accompanying slide presentation and in the company's filings with the SEC, including Form 10-K, 10-Q, and 8-K. ADC Therapeutics is providing this information as of today's date and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events, or circumstances, except as required by law. The company cautions investors not to place undue reliance on these forward-looking statements. Today's presentation also includes non-GAAP financial reporting. These non-GAAP measures should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with GAAP. You should refer to the company's second quarter 2026 earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures. I will now turn the call over to our CEO, Ameet Mallik. Ameet?

Thank you, Nicole. We are pleased to share that Zinlanza's commercial performance in the second quarter of 2026 continue to be broadly in line with recent quarters. We remain confident in the roles Zinlanta will continue to play as a differentiated single-agent treatment option for third-line plus DLBCL patients. Turning to our pipeline progress, as previously disclosed, we announced top-line results for LOTUS 5 in June. Based on this data, we held a pre-SVLA meeting with the FDA, and following the meeting, we are assessing the best regulatory path forward. Mohamed will share more details regarding the FDA feedback and our regulatory strategy. Further to this, the full LOTUS V data have now been submitted for presentation at ASH and we are preparing to submit for publication with compendia submission to follow. For LOTUS VII, we were pleased to complete enrollment of 100 patients at the selected dose level of Xenlanta plus clofidimab as shared in June and have submitted an abstract to ASH for presentation of the data, which we continue to believe demonstrates the most compelling combination data generated to date in Second Line Plus DLBCL, with a safety profile generally consistent with prior Lotus 7 disclosures. With these data, we believe that Zynlanta Plus Clofitimab offers an opportunity to take a leading Second Line position in the context of the evolving competitive landscape solidifying Xenlanta as a foundational therapy in DLBCL. Beyond this, we are preparing to submit for publication of the LOTUS-7 data with compendia submission to follow. Simultaneously, we are exploring the potential regulatory pathway for this combination and expect to submit for breakthrough designation this year. With respect to the multicenter investigator-initiated trials of Xenlanta in indolent lymphomas, updated marginals on lymphoma data was submitted to ASH with publication and compendia submission to follow. Presentation of updated follicular lymphoma data is anticipated in the second quarter of 2027 with publication and compendia submission to follow. We also intend to assess potential regulatory pathways for these endolymphomas and expect to submit for a breakthrough designation for . Moving now to corporate updates. We announced a strategic reorganization in June. As part of this, we implemented a reduction in our workforce of approximately 17%, as well as additional operational efficiencies, resulting in cost savings of approximately $10 million on an annualized basis. As shared at that time, with these changes, we are resourced to deliver on our key clinical, regulatory, and manufacturing activities while maintaining the full externally facing footprint to support the continued commercialization of Zynlanta in the Third Line Plus DLVCL setting. Finally, we ended the second quarter of 2026 with a healthy cash balance of $219.1 million, maintaining our expected cash runway at least into 2028 and enabling us to deliver against our strategy. Now we'd like to take a moment to remind everyone of our strategy to grow Zynlanta. Currently, Zenlanta plays a clear role in the Third Line Plus DLBCL setting. As monotherapy, Zenlanta has a well-established profile of rapid, deep, and durable efficacy, as well as manageable safety with simple and convenient administration. Since FDA accelerated approval in 2021, Zenlanta monotherapy has been used in treating approximately 5,000 patients in the US. We believe this is just a starting point as we see the potential for Zenlanta to reach significantly more patients by expanding use into earlier Lantus therapy in DLBCL and into indolent lymphomas. Now I would like to turn the call over to Mohamed, our CMO, to share more on our pipeline.

Thank you, Ameet. I would now like to share more on our Lotus 5 and Lotus 7 studies as we continue to work towards expansions in Lantus in earlier lines of DLBCL. As a reminder, LUTUS-5 is our Phase III confirmatory study of the long-term, in combination with rituximab versus Argemux, in patients with second-line DPCL, which recently read out and met the primary endpoint of progression-free survival. As noted, we held a meeting with the FDA in early August to present and discuss the totality of the LUTUS-5 data, along with the Provincial Regulatory Pathway. During this meeting, The FDA noted substantial concerns regarding the benefit risk or verification of clinical benefit observed in LUTAS 5 trials. As such, the company is now assisting the regulatory path forward. We plan to provide an update on regulatory strategy and timing in the future. Beyond this, the data has been submitted to ASH. We are simultaneously pursuing publication for LUTAS 5 and potential compendia inclusions starting in 2027. Turning now to LUTAS 7, our Phase 1b trial combining Zolanta with the highly effective bispecific glufetamab in second line plus DLGCL patients. We recently announced completion of enrollment of 100 patients at the 150 microgram per kick dose. Of note, Consistent with other Glucetimab trials, the protocol for LUTF-7 recommends prophylaxis, including vaccination for virus, fungal, and bacterial infections, including PGP and Herbsvirus, which was not part of the LUTF-5 protocol. Here, we continue to be encouraged by the promising LUTF-7 data shared to date, which we believe demonstrates the potential for Zenonta plus Glufetamab to be the best in-class combination. With data on larger number of patients with longer follow-up has been submitted to ASH for presentation. These data support the company's belief that the Lanta plus Glufetamab demonstrates the most compelling combination data generated to date in second-line DLPCL with a safety profile. generally consistent with prior LUTAS 7 disclosures. Separately, we are preparing for submission of the full LUTAS 7 data for publication and, following that, plan to submit to Compendia for potential inclusion starting in 2027. In addition, based on this potentially track-changing LUTAS 7 data, the company plans to submit for breakthrough designation this year and is assessing a phase three trial for the combination of Zenlanta plus Gruvitamab. Moving forward, we plan to work closely with the FDA to determine the best path forward to achieve the full approval and advance the Zenlanta combinations into earlier lines of therapy in DL-PCL. In the meantime, we remain confident that the loan that will continue to play a meaningful role for patients with B-cell malignancies within its currently approved third line plus VLDCL settings. With that, I would like to turn the call over to Peter Carmona, our CFO.

Thank you, Mohamed. On the financial front, The Montanet product revenues in the second quarter of 2026 were $18.6 million as compared to $18.1 million in the same quarter in 2025. Cost of product sales was $2.3 million and $6 million for the second quarter and six months ended June 30, 2026 as compared to $0.8 million and $2.9 million for the same periods in 2025. The increases compared to prior year are primarily driven by a changing focus of personnel from research and development clinical supply activities to commercial manufacturing activities. Total operating expenses were $44.7 million for the second quarter. On an on-gap basis, total adjusted operating expenses were $37.2 million for the quarter and were down by 22% over the prior year, primarily driven by lower R&D expenses. Ameet noted, we expect to save an additional $10 million on an annual basis as a result of the strategic reorganization we announced in June. On a gap basis, we reported a net loss of $16.6 million for the second quarter of 2026 as compared to a net loss of $56.6 million for the same period in 2025. The second quarter of 2026 included a one-time expense related to the strategic reorganization, while the year-ago quarter included restructuring, impairment, and related costs from the June 2025 strategic reprioritization and restructuring plan. On a non-GAAP basis, the adjusted net loss was $16.3 million for the second quarter of 2026 as compared to a net loss of $28.7 million for the same period in 2025. The lower net loss on a non-GAAP basis was primarily due to lower operating expenses. The year-over-year changes on a per-share basis were additionally impacted by the higher number of weighted average shares outstanding. You can find the reconciliation of GAAP to non-GAAP measures for the second quarter in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation. At the end of the second quarter, we had cash equivalence of $219.1 million as compared to $231 million as of March 31st, 2026, a change primarily driven by cash use in operations. This provides us with an expected cash runway at least into 2028. With that, I will turn the call back over to Ameet. Ameet?

Thank you, Pepe. To close, we are pleased by the commercial performance and the role that Xenlanta monotherapy continues to play in Third Line Plus DLBCL. We look forward to presentation of data from LOTUS 5, LOTUS 7, and MZL before year end with publication and potential companion inclusion to follow. Following the FDA pre-SBLA meeting, we are assessing regulatory approaches to determine the best path forward for the Lotus 5 trial. At the same time, we believe we have an opportunity for Zynlanta plus clofidamab to take a leading second-line position in DLBCL as a potential best-in-class bispecific combination and are actively assessing the potential regulatory path forward. Together, we anticipate we can grow Zynlanta beginning in 2027 as we work to make a meaningful difference and the lives of many more patients with B-cell malignancies. We can now open the line for questions.

Operator?

Thank you.

Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any key. One moment, please, for your first question. Your first question comes from Eric Smith with Kantor. Please go ahead.

Thanks for taking my question. I appreciate all the updates. Maybe just on the status of the current accelerated approval for Zinlanta, given the questions around risk-benefit from Lotus 5, was there any FDA discussion maintaining that accelerated approval status?

Yeah, it's a great question. So first of all, all the discussions with the FDA were related only to the trial. All their comments were specific to the combination of the MONTA plus rituximab on the trial. So there was no feedback at all about the single agent. So we remain confident that the monotherapy will stay on the market, will continue to have accelerated approval. and we're committed to working with the FDA to make sure that we can satisfy the full approval, either through Lotus 5 or through another study.

Thank you, Ameet. And then on Lotus 7 and your characterization of the most recent efficacy data that you guys have seen is compelling and consistent in safety. Have you essentially now seen the final ASH presentation and do your comments pertain to that? In other words, you know, Do you know exactly what you'll present and is it consistent with that statement?

Yeah, so we've already submitted the abstract for ASH, which contains the vast majority of the 100 patients that we enrolled.

So the belief that I'm sharing with you about the fact that we think we have very compelling efficacy and safety data is reflective of that ASH abstract. Obviously, for disclosure reasons, you can imagine we don't want to share all the details, but we do believe that We have very compelling data, both from an efficacy and a safety standpoint, within the Lotus 7 data that was submitted to ASH.

Thank you. And one more question, if I may, with regard to exploring a Phase 3 pathway for the combination in Lotus 7. Is that something you're exploring with Roche or by yourselves?

Yeah, I don't want to comment on that. Obviously, we have a great partnership with Roche. They've given us great feedback throughout, but what I would say is we've had lots of discussions, but also lots of thought, as you can imagine, even independent of the feedback we have today about a potential phase redesign, because we know that this data is so compelling that there could be significant upside to the asset by potentially pursuing phase redesign. So it's something we've been thinking about for a long time. The team has already been preparing on different design options that we do plan to file for a breakthrough designation this year and to discuss with the FDA potential designs.

Thank you for taking my questions. Yeah, thank you, Eric.

Your next question comes from Michael Schmidt with Guggenheim Securities. Please go ahead.

Hey, this is Sarah on for Michael. Thanks so much for taking my question. Just wanted to follow on quickly on the phase three plans, whether you could give any color on sort of timeline for that, now that it appears to be sort of more of the future looking focus. And then additionally had a sort of a question on the Lotus 5 data. So I know you've mentioned the 105 day period for monitoring adverse events after treatment. I was wondering if you could comment on the timing of the deaths.

So first of all, I just want to emphasize we have a positive study for Lotus 5.

So we still are assessing possibilities to identify the best regulatory approach for Lotus 5. I mean, specifically, we're considering whether additional data, risk management options, or modifications to the potential label can address the update concerns of Lotus 5. So we are doing that. In parallel, given that we have, you know, we think potentially practice changing data on hand with the Lotus 7, we're also in parallel going to file for breakthrough designation and explore a phase three approach there. So it's too premature at this point, as you can imagine, while we're still gathering input from the medical community and obviously have to collaborate with the FDA on a final design to talk about timing and cost. But I just want to reemphasize that those two things are going in parallel. And then With regards to the 105-day safety window, in terms of capturing AEs post-alaskos, that's the same, by the way, in LOTUS-7 as well. And one thing I want to emphasize is that, as Mohamed mentioned on the call, there was a big difference between LOTUS-5 and LOTUS-7, particularly with regards to the prophylactic measures taken. So in LOTUS-7, consistent with a lot of the other, with the other glorified trials that have been run, in Lotus 7 recommends prophylaxis including vaccinations for viral, fungal, and bacterial infections. That was not part of the Lotus 5 protocol. So while the time period that we're capturing AEs are very similar, there was a pretty big difference in terms of prophylaxis in the protocol between 5 and 7.

Appreciate it. Thank you.

Thank you.

Your next question comes from Mari Raycraft with Jefferies LLC. Please go ahead.

Hi, good morning. This is James on for more. Thanks for taking our questions. Can you provide more detail on the type of grade 5 infections that were observed in Lotus 5 and whether those events would have been expected to be mitigated by the prophylactic and vaccination strategies now incorporated into Lotus 7? Did other infections occur that aren't addressed by those vaccines? And I have thought well back to that.

Yeah, so the primary type of infections were bacterial, which is why we think that prophylactic could play a role.

Got it. And how do you think about the potential read-through from LOTUS 5, Grade 5 signal to potential NCC compendia inclusion and adoption of the dinlantaglifidimab combination within an academic community? Could the LOTUS 5 impact the NCC language, and could there be any safety monitoring requirements?

I don't think there will be any read-through in terms of LOTUS 7 compendia including Two very different studies, two different regimens. And as I mentioned, the protocol is different, which we think can help to contribute to some of the safety differences. Just as a reminder, obviously I can't speak to the data we have on hand, but I can speak to the prior disclosure that we had. We had a very low percent of grade five events, approximately 4%, if you look at our last disclosure we had in December on the 49 patients that we recorded. So I do think there's a difference, and we don't think that would be a read-through to Lotus 7.

or to any potential NCCN or any inclusion.

Very helpful. Thank you.

You now have a question from Leonid Timishev with RBC Capital Markets. Please go ahead.

Hi, guys. Josh on for Leo here. Thanks for taking my question. I was wondering whether or not The FDA, in their feedback in response to the Phase 3 run-up, did they provide any kind of indication of what an effective path forward might look like and what strategies you guys are thinking about at the time being? Thanks.

Yeah, and I think, you know, typical in what you'd have in the pre-SVLA meeting, we share the data results and you're aligning on the package for an SVLA submission. During that, as typical with any other of PS Daily, meaning they share concerns that they have with the data. And so right now, we're basically, you know, going through the feedback and assessing whether additional data risk management options or modifications to the potential label can help to address those FDA concerns.

And that's the basis of which we're evaluating our path forward for LISP5. Thanks, Chris. Thank you.

As a reminder, if you wish to ask a question, please press star followed by the one. Your next question comes from Rob Burns with HC Wainwright. Please go ahead.

Hi, this is Ameet on for Rob. Thank you for taking our questions. We're just wondering if you saw 2q product revenue increase versus 2q25. And I was wondering if you've seen any changes in patient starts or unit demand dosing or physician prescribing behaviors that slow despite disclosure. And then for my second question, I was wondering if in your conversations with the FDA, did they focus on the PFS in patients 75 or older and if that would influence eligibility criteria or future label. Thank you.

Yeah, so with regards to sale, we haven't seen any impact.

If you look at the volume in Q2, very consistent with prior quarters. And we don't think that there will be. If you look overall over the past several quarters, the commercial performance in the third line plus setting has been relatively consistent. And that's because

so a lot of that has established place in that third line of thought setting, and we don't expect any impact on monotherapy sales.

And then remind me again, I'm sorry, your second question? No problem. Oh, you're talking 175 or older, right? Yes, thank you.

Yeah. We don't think it'll have any impact on other studies.

You know, I think obviously, you know, older patients, specifically with infection, We think that the prophylaxis, you know, can play a role. And that's also why the protocol, again, I want to stress the LODIS 7 versus LODIS 5 are quite different. So the each study is on its own. You know, I don't think that there's a read-through on this. We certainly learned a lot from LODIS 5 and we're happy with the differences in the protocol, of course, that we're seeing in LODIS 7. So we don't see any read-through from LODIS 5 to either the current indication or other potential combinations.

Thank you.

There are no further questions at this time, so I will now turn the call over to Ameet Mallik for closing remarks. Please continue.

Well, thank you all for joining the call today and for your continued support.

We look forward to keeping you updated on our progress. Operator, you may now end the call.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.