ADC Therapeutics Q2 2026 Earnings Call Transcript

Key Takeaways

  • Negative Sentiment: FDA raised substantial benefit-risk concerns regarding the LOTIS-5 combination of ZYNLONTA and rituximab, leaving ADC Therapeutics assessing whether additional data, risk-management measures, or label changes can support a regulatory filing.
  • Positive Sentiment: LOTIS-7 enrollment reached 100 patients, and management described the ZYNLONTA-plus-glofitamab data submitted to ASH as potentially practice-changing, with plans to seek breakthrough designation and evaluate a Phase III trial.
  • Neutral Sentiment: Management said the FDA’s LOTIS-5 concerns were specific to the combination trial and did not affect ZYNLONTA monotherapy, which the company expects to remain available under accelerated approval in third-line-plus DLBCL.
  • Positive Sentiment: Q2 ZYNLONTA revenue was broadly stable at $18.6 million, while adjusted operating expenses fell 22% year over year; the June reorganization is expected to generate approximately $10 million in annual savings and extend cash runway into at least 2028.
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Earnings Conference Call
ADC Therapeutics Q2 2026
00:00 / 00:00

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Operator

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 13th, 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications. Please go ahead.

Nicole Riley
Nicole Riley
Head of Investor Relations and Corporate Communications at ADC Therapeutics

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 am 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.

Nicole Riley
Nicole Riley
Head of Investor Relations and Corporate Communications at ADC Therapeutics

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.

Nicole Riley
Nicole Riley
Head of Investor Relations and Corporate Communications at ADC Therapeutics

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.

Nicole Riley
Nicole Riley
Head of Investor Relations and Corporate Communications at ADC Therapeutics

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?

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Thank you, Nicole. We are pleased to share that ZYNLONTA's commercial performance in the second quarter of 2026 continued to be broadly in line with recent quarters. We remain confident in the role ZYNLONTA 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 LOTIS-5 in June. Based on this data, we held a pre-sBLA 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.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Further to this, the full LOTIS-5 data have now been submitted for presentation at ASH, and we are preparing to submit for publication with compendia submission to follow. For LOTIS-7, we were pleased to complete enrollment of 100 patients at the selected dose level of ZYNLONTA plus glofitamab, 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 LOTIS-7 disclosures.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

With these data, we believe that ZYNLONTA plus glofitamab offers an opportunity to take a leading second-line position in the context of the evolving competitive landscape, solidifying ZYNLONTA as a foundational therapy in DLBCL. Beyond this, we are preparing to submit for publication of the LOTIS-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.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

With respect to the multi-center investigator-initiated trials of ZYNLONTA in indolent lymphomas, updated marginal zone 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 indolent lymphomas and expect to submit for a breakthrough designation for MZL.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

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 ZYNLONTA in the third-line plus DLBCL setting.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

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, I'd like to take a moment to remind everyone of our strategy to grow ZYNLONTA. Currently, ZYNLONTA plays a clear role in the third-line plus DLBCL setting.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

As monotherapy, ZYNLONTA 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, ZYNLONTA monotherapy has been used in treating approximately 5,000 patients in the U.S. We believe this is just the starting point as we see the potential for ZYNLONTA to reach significantly more patients by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas. I would now like to turn the call over to Mohamed, our CMO, to share more on our pipeline.

Mohamed Zaki
Mohamed Zaki
Chief Medical Officer at ADC Therapeutics

Thank you, Ameet. I would now like to share more on our LOTIS-5 and LOTIS-7 studies as we continue to work towards expansion of ZYNLONTA in earlier lines of DLBCL. As a reminder, LOTIS-5 is our phase III confirmatory study of ZYNLONTA in combination with rituximab versus R-GemOx in patients with second-line DLBCL, 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 LOTIS-5 data, along with the potential regulatory pathway.

Mohamed Zaki
Mohamed Zaki
Chief Medical Officer at ADC Therapeutics

During this meeting, the FDA noted substantial concerns regarding the benefit-risk or verification of taken benefit observed in LOTIS-5 trial. As such, the company is now assessing 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 LOTIS-5 and potential compendia inclusion starting in 2027. Turning now to LOTIS-7, our phase I-B trial combining ZYNLONTA with the highly effective bispecific glofitamab in second-line plus DLBCL patients.

Mohamed Zaki
Mohamed Zaki
Chief Medical Officer at ADC Therapeutics

We recently announced completion of enrollment of 100 patients at the 150 µg per kg dose. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis, including vaccination for viral, fungal, and bacterial infections, including PJP and herpes virus, which was not part of the LOTIS-5 protocol. Here, we continue to be encouraged by the promising LOTIS-7 data shared to date, which we believe demonstrates the potential for ZYNLONTA plus glofitamab to be the best-in-class combination.

Mohamed Zaki
Mohamed Zaki
Chief Medical Officer at ADC Therapeutics

With data on larger number of patients with longer follow-up has been submitted to ASH for presentation. This data support the company's belief that ZYNLONTA plus glofitamab demonstrates the most compelling combination data generated to date in second-line DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures. Separately, we are preparing for submission of the full LOTIS-7 data for publication and following that, plan to submit to compendia for potential inclusion starting in 2027.

Mohamed Zaki
Mohamed Zaki
Chief Medical Officer at ADC Therapeutics

In addition, based on this potentially practice-changing LOTIS-7 data, the company plans to submit for breakthrough designation this year and is assessing a phase III trial for the combination of ZYNLONTA plus glofitamab. Moving forward, we plan to work closely with the FDA to determine the best path forward to achieve the full approval and advance the ZYNLONTA combinations into earlier lines of therapy in DLBCL. In the meantime, we remain confident that ZYNLONTA will continue to play a meaningful role for patients with B-cell malignancies within its currently approved third-line plus DLBCL setting. With that, I would like to turn the call over to Pepe Carmona, our CFO.

Pepe Carmona
Pepe Carmona
CFO at ADC Therapeutics

Thank you, Mohamed. On the financial front, ZYNLONTA net 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 change in focus of personnel from research and development clinical supply activities to commercial manufacturing activities.

Pepe Carmona
Pepe Carmona
CFO at ADC Therapeutics

Total operating expenses were $44.7 million for the second quarter. On a non-GAAP 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. As 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 GAAP 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.

Pepe Carmona
Pepe Carmona
CFO at ADC Therapeutics

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.

Pepe Carmona
Pepe Carmona
CFO at ADC Therapeutics

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 companion 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 and cash equivalents of $219.1 million as compared to $231 million as of March 31, 2026, a change primarily driven by cash dues 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?

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Thank you, Pepe. To close, we are pleased by the commercial performance and the role that ZYNLONTA monotherapy continues to play in third-line-plus DLBCL. We look forward to presentation of data from LOTIS-5, LOTIS-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 LOTIS-5 trial.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

At the same time, we believe we have an opportunity for ZYNLONTA plus glofitamab 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 ZYNLONTA beginning in 2027 as we work to make a meaningful difference in the lives of many more patients with B-cell malignancies. We can now open the line for questions. Operator?

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 set the handset before pressing any key. One moment, please, for your first question. Your first question comes from Eric Schmidt with Cantor. Please go ahead.

Eric Schmidt
Eric Schmidt
Analyst at Cantor

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

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Yeah. A great question. First of all the discussions with the FDA were related only to the trial. All their comments were specific to the combination of ZYNLONTA plus rituximab on the trial. There was no feedback at all about the single agent. 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 LOTIS-5 or through another study.

Eric Schmidt
Eric Schmidt
Analyst at Cantor

Thank you, Ameet. On LOTIS-7 and your characterization of the most recent efficacy data that you guys have seen as compelling and consistent in safety, have you essentially now seen the final ASH presentation, and do your comments pertain to that? In other words, do you know exactly what you will present, and is it consistent with that statement?

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Yeah. We have already submitted the abstract for ASH, which contains obviously the vast majority of the 100 patients that we enrolled. The belief that I am sharing with you about the fact that we think we have very compelling efficacy and safety data is reflective of that ASH abstract, where obviously for disclosure reasons, you can imagine we do not 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 LOTIS-7 data that was submitted to ASH.

Eric Schmidt
Eric Schmidt
Analyst at Cantor

Thank you. One more question, if I may, with regard to exploring a phase III pathway for the combination in LOTIS-7. Is that something you are exploring with Roche or by yourselves?

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

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

Eric Schmidt
Eric Schmidt
Analyst at Cantor

Thank you for taking my questions.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Yeah. Thank you, Eric.

Operator

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

Analyst at Guggenheim Securities

Hey, this is Sarah on for Michael. Thanks so much for taking my question. Just wanted to follow on quickly on the phase III 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. Additionally, had a sort of A question on the LOTIS-5 data. I know you mentioned the 105-day period for monitoring adverse events after treatment. I was wondering if you could comment on the timing of the deaths.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

First of all, I just want to emphasize we have a positive study for LOTIS-5. We still are assessing possibilities to identify the best regulatory approach for LOTIS-5. Specifically, we are considering whether additional data, risk management options, or modifications to the potential label can address the updates in terms of LOTIS-5. We are doing that in parallel given that we have, we think, potentially practice-changing data on hand with the LOTIS-7. We are also, in parallel, going to file for breakthrough designation and explore a phase III approach there.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

It is too premature at this point, as you can imagine, while we are 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. With regards to the 105-day safety window in terms of capturing AEs post-last dose, that is the same, by the way, in LOTIS-7 as well.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

One thing I want to emphasize is that, as Mohamed mentioned on the call, there was a big difference between LOTIS-5 and LOTIS-7, particularly with regards to prophylactic measures taken. In LOTIS-7, consistent with a lot of the other glofitamab trials that have been run, LOTIS-7 recommends prophylaxis, including vaccinations for viral, fungal, and bacterial infections. That was not part of the LOTIS-5 protocol. While the time period that we are capturing AEs is very similar, there was a pretty big difference in terms of prophylaxis and the protocol between five and seven.

Analyst at Guggenheim Securities

Appreciate it. Thank you.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Thank you.

Operator

Your next question comes from Maury Raycroft with Jefferies LLC. Please go ahead.

Analyst at Jefferies LLC

Hi. Good morning. This is James on for Maury. Thanks for taking our questions. Can you provide more detail on the type of grade five infections that were observed in LOTIS-5, and whether those events would have been expected to be mitigated by the prophylactic and vaccination strategies now incorporated into LOTIS-7? Did other infections occur that aren't addressed by those vaccines? I have a follow-up after that.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Yeah. The primary type of infections were bacterial, which is why we think that prophylaxis could play a role.

Analyst at Jefferies LLC

Got it. How do you think about the potential read-through from LOTIS-5 grade five signal to potential NCCN compendia inclusion and adoption of the ZYNLONTA plus glofitamab combination within the academic community? Could the LOTIS-5 impact the NCCN language, and could there be any safety monitoring requirements?

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Yeah, I don't think there will be any read-through in terms of LOTIS-7 compendia inclusion. Two very different studies, two different regimens. 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 cannot 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 is a difference, and we do not think there would be a read-through to LOTIS-7 or to any potential NCCN or compendia inclusion.

Analyst at Jefferies LLC

Got it. Very helpful. Thank you.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Thank you.

Operator

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

Analyst at RBC Capital Markets

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 III round, do 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.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Yeah, and I think typical in what you'd have in the pre-sBLA meeting, we share the data results and you're aligning on the package for an sBLA submission. During that, as typical with any other pre-sBLA meeting, they share concerns that they have with the data. Right now we're basically going through the feedback and assessing whether additional data, risk management options, or modifications to the potential label can help to address those update concerns. That's the basis of which we're evaluating our path forward for LOTIS-5.

Analyst at RBC Capital Markets

Thanks, guys.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Thank you.

Operator

As a reminder, if you wish to ask a question, please press star followed by the 1. Your next question comes from Rob Burns with H.C. Wainwright. Please go ahead.

Analyst at H.C. Wainwright

Hi, this is Ahmed on for Rob. Thank you for taking our questions. I was just wondering if you saw Q2 product revenue increase versus Q2 2025. I was wondering if you've seen any changes in patient starts or unit demand dosing or physician prescribing behaviors since LOTIS-5 disclosure. 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.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Yeah. With regards to sale, we haven't seen any impact. If you look at the volume in Q2, very consistent with prior quarters. We don't think that there will be. If you look overall over the past several quarters, the commercial performance of the monotherapy in the third line plus setting has been relatively consistent, and that's because ZYNLONTA has an established place in that third line plus setting, and we don't expect any impact on monotherapy sales. Remind me again, I'm sorry, your second question.

Analyst at H.C. Wainwright

No problem. I was wondering if-

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

Oh, just about patients 75 or older, right?

Analyst at H.C. Wainwright

Yes. Thank you.

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

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

Analyst at H.C. Wainwright

Thank you.

Operator

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

Ameet Mallik
Ameet Mallik
CEO at ADC Therapeutics

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.

Operator

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

Executives
    • Nicole Riley
      Nicole Riley
      Head of Investor Relations and Corporate Communications
    • Mohamed Zaki
      Mohamed Zaki
      Chief Medical Officer
    • Pepe Carmona
      Pepe Carmona
      CFO
Analysts