ADCT

Image source: The Motley Fool. Thursday, Aug. 13, 2026, at 8:30 a.m. ET Head of Investor Relations and Corporate Communications-Nicole Riley Chief Executive Officer-Ameet Mallik Chief Medical Officer-Mohamed Zaki Chief Financial Officer-Pepe Carmona Operator: Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q2 2026 Earnings Conference Call. [Operator Instructions] 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. Nicole Riley: Thank you, operator. Today, we issued a press release announcing our second quarter 2026 financial results and business update. This release and the slides we will use in today's presentation are available on the Investors 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? Ameet Mallik: 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. 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 demonstrate the most compelling combination data generated to date in second-line plus DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures. 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. With respect to the multicenter 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 breakthrough designation for MZL. 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. 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. 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 a 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. Now I would like to turn the call over to Mohamed, our CMO, to share more on our pipeline. Mohamed Zaki: Thank you, Ameet. I would now like to share more on our LOTIS-5 and LOTIS-7 studies as we continue to work toward 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. During this meeting, the FDA noted substantial concerns regarding the benefit risk or verification of clinical benefit observed in the 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 Ib trial combining ZYNLONTA with the highly effective bispecific glofitamab in second-line plus DLBCL patients. We recently announced completion of enrollment of 100 patients at the 150 micrograms per kg dose. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis, including vaccinations 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. The data on a larger number of patients with longer follow-up has been submitted to ASH for presentation. This data supports 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. 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 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. Jose Carmona: 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 6 months ended June 30, 2026, as compared to $0.8 million and $2.9 million for the same period 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. 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. The second quarter of 2026 included a onetime 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 and cash equivalents of $219.1 million as compared to $231 million as of March 31, 2026, a change primarily driven by cash used 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: 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 compendia 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. 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: [Operator Instructions] Your first question comes from Eric Schmidt with Cantor. Eric Schmidt: 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: Yes, 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 ZYNLONTA 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. We'll 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: And then on LOTIS-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, do you know exactly what you'll present? And is it consistent with that statement? Ameet Mallik: Yes. So we've already submitted the abstract for ASH, which contains obviously 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. We 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 LOTIS-7 data that was submitted to ASH. Eric Schmidt: And one more question, if I may, with regard to exploring a Phase III pathway for the combination in LOTIS-7. Is that something you're exploring with Roche or by yourselves? Ameet Mallik: I don't want to comment on that. Obviously, we have a great partnership with Roche, and 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 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 trial. So it's something we've been thinking about for a long time. The team has already been preparing on different design options, and we do plan to file for breakthrough designation this year and to discuss with the FDA potential designs. Operator: Your next question comes from Michael Schmidt with Guggenheim Securities. Unknown Analyst: This is Sarah on for Michael. Just wanted to follow on quickly on the Phase III plans, whether you could give any color on sort of time line for that now that it appears to be sort of more of the future-looking focus. And then additionally, I had a sort of a question on the LOTIS-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. Ameet Mallik: So first of all, I just want to emphasize we have a positive study for LOTIS-5. So we still are assessing possibilities to identify the best regulatory approach for LOTIS-5. I mean specifically, we're considering whether additional data risk management options or modifications to the potential label can address the FDA concern. So we are doing that. In parallel, given that we have, we think, potentially practice-changing data on hand with the LOTIS-7, we're also in parallel going to file for breakthrough designation and explore a Phase III 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 talk with the FDA on the final design to talk about timing and costs. But I just want to reemphasize that those 2 things are going in parallel. And then with regards to the 105-day safety window in terms of capturing AEs post the last dose, that's the same, by the way, in LOTIS-7 as well. And 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 the prophylactic measures taken. So in LOTIS-7, consistent with a lot of the other -- with 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. So while the time period that we're capturing AEs is very similar, there was a pretty big difference in terms of prophylaxis in the protocol between 5 and 7. Operator: Your next question comes from Maury Raycroft with Jefferies LLC. Unknown Analyst: This is James on for Maury. Can you provide more detail on the type of Grade 5 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 in LOTIS-7? Did other infections occur that aren't addressed by those vaccines? And I have a follow-up after that. Ameet Mallik: Yes. So the primary type of infections were bacterial, which is why we think that prophylaxis could play a role. Unknown Analyst: Got it. And how do you think about the potential read-through from LOTIS-5 Grade 5 signal to potential NCCN compendia inclusion and adoption of the ZYNLONTA glofitamab combination within the academic community? Could LOTIS-5 impact the NCCN language? And could there be any safety monitoring requirements? Ameet Mallik: Yes. I don't think there will be any read-through in terms of LOTIS-7 compendia inclusion. Two very different studies, 2 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 can't speak to the data that we have on hand, but I can speak to the prior disclosure that we had. We had a very low percent of Grade 5 events, approximately 4% if you look at our last disclosure we had in December on the 49 patients that we reported. So I do think there's a difference and we don't think there would be a read-through to LOTIS-7 or to any potential NCCN or compendia inclusion. Operator: We now have a question from Leonid Timashev with RBC Capital Markets. Unknown Analyst: Josh on for Leo here. I was wondering whether or not the FDA in their feedback in response to the Phase III, 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? Ameet Mallik: Yes. And I think typical in what you 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 it is typical with any other pre-sBLA meeting, they share concerns that they have with the data. And so right now, we're basically going through the feedback and assessing whether additional data risk management options or modification 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 LOTIS-5. Operator: [Operator Instructions] Your next question comes from Rob Burns with H.C. Wainwright. Unknown Analyst: This is Ahmed on for Rob. I was just wondering if you saw Q2 product revenue increase versus Q2 '25. And I was wondering if you've seen any changes in patient starts or unit demand dosing or physician prescribing behaviors since LOTIS-5 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? Ameet Mallik: Yes. So with regard to sales, we haven't seen any impact. If you look at the volume in Q2, very consistent with prior quarters. So -- and 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 the third-line plus setting, and we don't expect any impact on monotherapy sales. And then remind me again, I'm sorry, your second question. Unknown Analyst: No problem. I was wondering if... Ameet Mallik: Oh, just about patients 75 or older, right? Unknown Analyst: Yes. Ameet Mallik: Yes. We don't think it will 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 the 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. 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: 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. Before you buy stock in Adc Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Adc Therapeutics wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $432,621!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,314!* That performance is why people listen. With a track record of beating the S&P 500 by nearly 5x, Stock Advisor offers a distinct advantage. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. ZYNLONTA monotherapy maintained consistent commercial performance in the third-line plus DLBCL setting, serving as a foundational revenue driver while the company pursues earlier-line expansions. The LOTIS-5 Phase III confirmatory trial met its primary endpoint of progression-free survival, yet faces regulatory uncertainty due to FDA concerns regarding the benefit-risk profile. Management attributes safety concerns in LOTIS-5 primarily to bacterial infections, noting that the trial protocol lacked the rigorous prophylactic measures now standard in newer studies. Strategic reorganization and a 17% workforce reduction were implemented to optimize the cost structure, extending the cash runway into 2028 while preserving commercial and clinical capabilities. The company is shifting focus toward the LOTIS-7 combination (ZYNLONTA plus glofitamab), which management believes offers a superior efficacy and safety profile for second-line DLBCL. Operational efficiencies and strategic reorganizations are expected to generate annual savings, though a recent shift in personnel focus from R&D to commercial manufacturing has driven an increase in the cost of product sales. Management is assessing multiple regulatory options for LOTIS-5, including potential label modifications or enhanced risk management strategies to address FDA feedback. Breakthrough designation filings for both the LOTIS-7 combination in DLBCL and ZYNLONTA in marginal zone lymphoma (MZL) are planned for late 2026. The company is actively designing a potential Phase III trial for the ZYNLONTA plus glofitamab combination to solidify a leading position in second-line therapy. Anticipated data presentations at ASH for LOTIS-5, LOTIS-7, and MZL are expected to serve as catalysts for potential compendia inclusion starting in 2027. Financial guidance assumes the current cash balance of $219.1 million is sufficient to fund operations through key clinical and regulatory milestones over the next two years. A strategic reorganization resulted in approximately $10 million in annualized cost savings through headcount reduction and operational streamlining. FDA feedback from the pre-sBLA meeting highlighted 'substantial concerns' regarding clinical benefit verification in LOTIS-5, creating a potential delay in full approval for the current indication. The company reported a one-time expense related to the June 2026 reorganization, though non-GAAP operating expenses decreased 22% year-over-year due to lower R&D spend. Management explicitly distinguished the safety profile of the monotherapy from the combination trials, asserting that monotherapy accelerated approval remains secure. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that FDA concerns were strictly limited to the ZYNLONTA plus rituximab combination trial and did not involve the single-agent profile. The company remains confident that the monotherapy will maintain its market position and accelerated approval status while they work to satisfy full approval requirements. The LOTIS-7 protocol includes mandatory prophylaxis for viral, fungal, and bacterial infections (including PJP and herpes), which was absent in the LOTIS-5 design. Management believes these prophylactic measures, consistent with other glofitamab trials, address the Grade 5 infection signals observed in the earlier LOTIS-5 study. ADC Therapeutics is independently preparing Phase III design options for the ZYNLONTA plus glofitamab combination while maintaining a collaborative dialogue with Roche. The company intends to discuss specific trial designs with the FDA following the planned breakthrough designation submission later this year. Management reported no change in physician prescribing behavior, patient starts, or unit demand for ZYNLONTA monotherapy following the LOTIS-5 update. Second-quarter volumes remained consistent with historical trends, reinforcing the asset's established role in third-line plus DLBCL.

Second quarter 2026 net product revenue of $18.6 million; cash and cash equivalents of $219.1 million as of June 30, 2026 LOTIS-7, LOTIS-5 and MZL IIT data submitted for presentation at ASH Company evaluating regulatory path for ZYNLONTA® to obtain full approval and advance into earlier lines of DLBCL following LOTIS-5 pre-sBLA meeting Company to host conference call today at 8:30 a.m. EDT LAUSANNE, Switzerland, Aug. 13, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the second quarter ended June 30, 2026, and provided recent operational updates. ZYNLONTA® commercial performance as a monotherapy in 3L+ diffuse large B-cell lymphoma (DLBCL) in the second quarter of 2026 continued to be broadly in line with recent quarters. Abstracts for LOTIS-5, LOTIS-7 and MZL IIT data have all been submitted to the 68th American Society of Hematology (ASH) Annual Meeting and Exposition and will be submitted for publication as well as potential compendia inclusion. The Company anticipates growth starting in 2027. Recently, the Company held a pre-supplemental Biologics License Application (sBLA) meeting with the U.S. Food and Drug Administration (FDA), during which the LOTIS-5 data was discussed. Following FDA meeting feedback regarding the benefit-risk observed in the LOTIS-5 trial, the Company is assessing the best regulatory path forward. Beyond this, enrollment in LOTIS-7 is now complete, and these data support the Company's belief that ZYNLONTA plus glofitamab demonstrates the most compelling combination data generated to date in 2L+ DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures. Based on this potentially practice-changing LOTIS-7 data, the Company is assessing a Phase 3 trial for the combination of ZYNLONTA plus glofitamab. As the Company continues to commercialize ZYNLONTA in the 3L+ DLBCL setting, we will work closely with the FDA to determine how to best obtain full approval and to advance ZYNLONTA combinations into earlier lines of therapy in DLBCL. "We are pleased by our second quarter performance, which reflects continued commercial momentum and strong operational discipline through ongoing cost reduction efforts. Over the course of this year, we have released LOTIS-5 data and completed the LOTIS-7 trial. With these data now in hand, we believe that ZYNLONTA plus glofitamab offers an opportunity to take a leading second-line plus position, in the context of the evolving competitive landscape, solidifying ZYNLONTA as a foundational therapy in DLBCL," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Additionally, following the FDA pre-sBLA meeting for the LOTIS-5 trial, we are assessing regulatory approaches to determine the best path forward." "As we work to advance ZYNLONTA into earlier lines of DLBCL, we remain confident that ZYNLONTA will continue to play a meaningful role for patients with B-cell malignancies, in the 3L+ DLBCL setting, and through potential compendia inclusion starting in 2027," said Mohamed Zaki, M.D., Ph.D., Chief Medical Officer of ADC Therapeutics. "We look forward to the presentation of the LOTIS-5, LOTIS-7 and MZL investigator-initiated trial data later this year and expect submission for publication. In addition, we expect to submit LOTIS-7 and MZL data to the FDA for Breakthrough Designation." Second Quarter 2026 Operational Updates and Upcoming Milestones LOTIS-5 pre-sBLA meeting held; Company evaluating regulatory path forward. In June 2026, the Company announced topline results from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab, which met the trial's primary endpoint of progression-free survival (PFS). The Company submitted full data to ASH. The Company recently held a pre-sBLA meeting with the FDA. During this meeting, the FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in this trial based on the imbalance in Grade 5 events, when assessed in the context of a marginal treatment benefit. Following this meeting, the Company is assessing the best regulatory path forward and plans to provide an update on regulatory strategy and timing in the near future. ZYNLONTA remains available under accelerated approval as a monotherapy in 3L+ DLBCL and the Company plans to continue to commercialize in this setting. LOTIS-7 trial completed enrollment. The LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with r/r DLBCL completed enrollment of 100 patients at the selected 150 µg/kg starting dose of ZYNLONTA. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis (including vaccinations) for viral, fungal, and bacterial infections (including PJP and herpesvirus), which was not a part of the LOTIS-5 protocol. The Company submitted LOTIS-7 data to ASH, which continues to demonstrate potential best-in-class bispecific combination data with a safety profile generally consistent with prior LOTIS-7 disclosures. The Company is preparing to submit the complete trial results for publication, which will then be submitted to compendia. The Company is also evaluating a regulatory pathway for this combination and plans to submit for Breakthrough Therapy designation (BTD) this year. Announced strategic reorganization to support ZYNLONTA growth opportunities and regulatory priorities. ADC Therapeutics implemented an approximately 17 percent workforce reduction globally and estimates that the reorganization will generate annualized estimated cost savings of approximately $10 million. The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. With these changes, the Company is resourced to deliver on its key clinical, regulatory, and manufacturing activities while maintaining its full externally facing medical affairs and commercial footprint to support ZYNLONTA. Investigator-Initiated trials (IITs) evaluating ZYNLONTA in additional B-cell malignancies continue to advance. The University of Miami Sylvester Comprehensive Cancer Center-led multi-center Phase 2 trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) and ZYNLONTA as a monotherapy to treat marginal zone lymphoma (MZL) are ongoing. Updated MZL data were submitted to ASH and the Company anticipates presentation of this data before the end of the year, with publication and compendia submission to follow. The Company also anticipates presentation of updated FL data in Q2 2027. The Company intends to assess potential regulatory pathways and plans to submit for BTD for MZL. Second Quarter 2026 Financial Results Product Revenues: Net product revenues were $18.6 million and $38.7 million for the second quarter and six months ended June 30, 2026, as compared to $18.1 million and $35.5 million for the same periods in 2025. The quarter-over-quarter increase was driven by higher price. The increase for the six-month period was primarily driven by volume increase, which reflects the normal variability in customer ordering patterns, as well as higher price. License Revenues and Royalties: License revenue and royalties were $0.6 million for the second quarter and $1.4 million for the six months ended June 30, 2026, as compared to $0.8 million and $6.4 million for the same periods in 2025. The decrease for the six-month period was primarily driven by a prior-year milestone received from our partner. Cost of Product Sales: Cost of product sales was $2.3 million and $6.0 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 increase in cost of product sales was primarily attributable to a $1.1 million increase for the second quarter and a $2.5 million increase for the six-month period in certain personnel costs. This reflects a change in focus of these personnel from research and development clinical supply activities to commercial manufacturing activities. Research and Development (R&D) Expense: R&D expense was $17.4 million and $37.2 million for the second quarter and six months ended June 30, 2026, as compared to $30.1 million and $59.0 million for the same periods in 2025. The decrease in R&D costs was primarily driven by a reduction in spending on discontinued programs and completion of the IND-enabling activities for our PSMA-targeting ADC. The decrease was also driven by a shift of certain personnel costs totaling $1.7 million for the quarter and $3.8 million for the six-month period to cost of product sales ($1.1 million QoQ/$2.3 million YoY), inventory capitalization, and selling and marketing expense, reflecting a change in focus of these personnel from research and development activities toward commercial manufacturing and fulfillment activities. Selling and Marketing (S&M) Expense: S&M expense was $12.6 million and $25.3 million for the second quarter and six months ended June 30, 2026, as compared to $10.1 million and $20.7 million for the same periods in 2025. The increase period-over-period was primarily due to higher marketing and advertising expenses and higher wages and benefits. General & Administrative (G&A) Expense: G&A expense was $9.7 million and $19.6 million for the second quarter and six months ended June 30, 2026, as compared to $8.8 million and $18.8 million for the same periods in 2025. The increase period-over-period was primarily due to increased professional and IT expenses, partially offset by lower wages and benefits. Restructuring, impairment and other related costs: In connection with the strategic reorganization and workforce reduction announced in June 2026, we incurred employee severance and related benefit costs of $2.7 million for the second quarter and six months ended June 30, 2026. In connection with the strategic reprioritization and restructuring plan announced in June 2025, we incurred $13.1 million in restructuring and impairment costs for the second quarter and six months ended June 30, 2025, which consisted of $6.7 million in employee severance and related benefit costs, and $6.4 million in non-cash impairment of assets in connection with the close down of the UK facility. Total Operating Expenses and Adjusted Total Operating Expenses: Total operating expenses were $44.7 million and $90.8 million for the second quarter and six months ended June 30, 2026, as compared to $63.0 million and $114.5 million for the same periods in 2025, a reduction of 29% and 21%, respectively. On a non-GAAP basis, total adjusted operating expenses were $37.2 million and $80.1 million for the second quarter and six months ended June 30, 2026, as compared to $47.8 million and $96.9 million for the same periods in 2025, a reduction of 22% and 17.3%, respectively. The reduction in total adjusted operating expenses was primarily driven by lower R&D expenses. Net Loss and Adjusted Net Loss: Net loss for the second quarter and six months ended June 30, 2026, was $16.6 million or $49.5 million, or a net loss of $0.11 and $0.32 per basic and diluted share, as compared to a net loss of $56.6 million and $95.2 million, or a net loss of $0.50 and $0.86 per basic and diluted share, for the same periods in 2025. On a non-GAAP basis, adjusted net loss for the second quarter and six months ended June 30, 2026, was $16.3 million or $36.0 million, or a net loss of $0.11 and $0.23 per basic and diluted share, as compared to a net loss of $28.7 million and $52.6 million, or a net loss of $0.25 and $0.48 per basic and diluted share, for the same periods in 2025. The lower net loss and adjusted net loss were primarily due to lower operating expenses, and on a per basic and diluted share basis, by a higher number of weighted average shares outstanding. Net loss was also favorably impacted by the change in fair value of warrants and the cumulative catch-up adjustment of the Company's deferred royalty obligation. Cash and Cash Equivalents: As of June 30, 2026, cash and cash equivalents were $219.1 million, compared to $261.3 million as of December 31, 2025, a change primarily driven by cash used in operations. The Company has an expected cash runway at least into 2028. Conference Call Details ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2026 financial results and provide a company update today at 8:30 a.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call. About ADC TherapeuticsADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA® (loncastuximab tesirine-lpyl). ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn. Use of Non-GAAP Financial Measures In addition to financial information prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP), this document also contains certain non-GAAP financial measures based on management's view of performance including: Adjusted total operating expensesAdjusted net lossAdjusted net loss per share Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-GAAP measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with GAAP. When preparing these supplemental non-GAAP measures, management typically excludes certain GAAP items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these GAAP items to be normal, recurring cash operating expenses; however, these items may not meet the GAAP definition of unusual or non-recurring items. Since non-GAAP financial measures do not have standardized definitions and meanings, they may differ from the non-GAAP financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other GAAP financial measures. The following items are excluded from adjusted total operating expenses: Share-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy. Restructuring, Impairment and Other Related Costs: We exclude from our adjusted financial measures costs associated with our execution of certain strategies and initiatives to streamline operations, achieve targeted cost reductions or reprioritize research and development activities. These costs may include employee severance, contract termination costs, facility closing and exit costs, asset impairment charges (which are non-cash) and other costs that we believe do not represent the performance of our business or have a direct correlation to our ongoing or future business operations. The following items are excluded from adjusted net loss and adjusted net loss per share: Share-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy. Certain Other Items: We exclude certain other significant items that we believe do not represent the performance of our business from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: restructuring, impairment and other related costs, changes in the fair value of warrant obligations and the effective interest expense associated with the senior secured term loan facility and the effective interest expense and cumulative catch-up adjustments associated with the deferred royalty obligation under the royalty purchase agreement with HealthCare Royalty Partners. See the attached Reconciliation of GAAP Measures to Non-GAAP Measures for explanations of the amounts excluded and included to arrive at the non-GAAP financial measures. About ZYNLONTA® ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com. ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; our ability to identify and execute on potential regulatory and compendia pathways; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA including our ability to adequately address the serious concerns related to the LOTIS-5 trial results raised by the FDA at the recent pre-sBLA submission meeting; the timing, submission and outcome of an sBLA related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA® as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA® in the United States and foreign jurisdictions and into earlier lines of therapy; whether future LOTIS-7 results will be consistent with or different from the prior disclosure, the timing, results and publication of the full LOTIS-7 trial data and potential compendia inclusion; future regulatory strategy for a Phase 3 trial for the combination of ZYNLONTA® plus glofitamab; our expected revenue growth in 2027 and the Company's ability to sustain or grow ZYNLONTA® revenue in the future; our expected cash runway into at least 2028 which assumes use of the minimum liquidity amount required to be maintained under its loan agreement covenants; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial strategy; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain or maintain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's clinical trials; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACT: Investors and MediaNicole RileyADC [email protected] +1 862-926-9040 View original content to download multimedia:https://www.prnewswire.com/news-releases/adc-therapeutics-reports-second-quarter-2026-financial-results-and-provides-operational-updates-302850226.html

Interested in ADC Therapeutics SA? Here are five stocks we like better. ZYNLONTA revenue remained stable: Second-quarter net product revenue rose to $18.6 million from $18.1 million a year earlier. Management said the existing third-line-plus DLBCL monotherapy indication remains unaffected by recent FDA feedback. FDA concerns cloud LOTIS-5: Regulators raised substantial concerns about the study’s benefit-risk profile and verification of treatment benefit, prompting ADC Therapeutics to reassess its regulatory strategy. The company is considering additional data, risk controls, or label changes. LOTIS-7 advances while costs fall: Enrollment was completed in the ZYNLONTA-glofitamab study, and the company plans to seek breakthrough therapy designation this year. Adjusted operating expenses fell 22% year over year, while a reorganization is expected to deliver approximately $10 million in annual savings. ADC Therapeutics (NYSE:ADCT) reported second-quarter 2026 net product revenue of $18.6 million for ZYNLONTA, up from $18.1 million in the prior-year period, while executives said the treatment’s commercial performance remained broadly consistent with recent quarters. The company also said it is reassessing the regulatory path for its LOTIS-5 confirmatory study after receiving FDA feedback that raised “substantial concerns” about the benefit-risk profile and verification of the treatment benefit observed in the trial. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be ZYNLONTA is currently approved under the FDA’s accelerated approval pathway as a single-agent treatment for patients with third-line-plus diffuse large B-cell lymphoma, or DLBCL. Chief Executive Officer Ameet Mallik said the company remains confident in the therapy’s role in that setting and does not expect the LOTIS-5 feedback to affect the existing monotherapy indication. “The discussions with the FDA were related only to the trial,” Mallik said during the company’s earnings call. “There was no feedback at all about the single agent.” → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand LOTIS-5 is a Phase III confirmatory trial evaluating ZYNLONTA in combination with rituximab against R-GemOx in patients with second-line DLBCL. The company said the study met its primary endpoint of progression-free survival and announced top-line results in June. However, following an early-August pre-supplemental biologics license application meeting, Chief Medical Officer Mohamed Zaki said the FDA expressed substantial concerns regarding the benefit-risk assessment and verification of the benefit observed in the study. → On Holding's Price Stumble May Be an Opening for a Company Built to Run ADC Therapeutics said it is assessing whether additional data, risk-management measures, or potential label modifications could address the agency’s concerns. The company did not provide a timeline for an updated regulatory strategy. In response to analyst questions regarding serious infections in LOTIS-5, Mallik said the primary type of infections involved bacterial infections. He noted that LOTIS-7, a separate study of ZYNLONTA in combination with glofitamab, includes recommendations for prophylaxis and vaccinations covering viral, fungal and bacterial infections, including Pneumocystis jirovecii pneumonia and herpes virus. Those measures were not included in the LOTIS-5 protocol. ADC Therapeutics submitted full LOTIS-5 data for presentation at the American Society of Hematology meeting and is pursuing publication. The company also expects to seek potential compendia inclusion beginning in 2027. The company completed enrollment of 100 patients at the selected ZYNLONTA dose level in LOTIS-7, a Phase Ib study evaluating ZYNLONTA plus glofitamab in second-line-plus DLBCL. ADC Therapeutics submitted an abstract containing data from most of the enrolled population to ASH. Mallik said the company believes the submitted data show compelling efficacy and safety, while Zaki said the combination has the potential to be a best-in-class regimen. The company did not disclose the updated data during the call. ADC Therapeutics plans to submit a request for breakthrough therapy designation for the ZYNLONTA-glofitamab combination this year and is evaluating a potential Phase III study. Mallik said the company is still gathering feedback from the medical community and would need to work with the FDA on a final trial design, making it too early to discuss timing or cost. Management said it does not expect the safety findings from LOTIS-5 to have implications for LOTIS-7 or for potential compendia inclusion of the latter regimen, citing differences in the study regimens and preventive-infection protocols. Mallik referenced the company’s prior December disclosure, which showed approximately 4% grade-five events among 49 patients in the earlier LOTIS-7 dataset. Beyond DLBCL, the company said updated investigator-initiated trial data in marginal zone lymphoma were submitted to ASH. Updated follicular lymphoma data are anticipated in the second quarter of 2027. ADC Therapeutics also plans to assess regulatory paths in indolent lymphomas and expects to seek breakthrough designation in marginal zone lymphoma. ADC Therapeutics reported total operating expenses of $44.7 million for the second quarter. On a non-GAAP basis, adjusted operating expenses were $37.2 million, a 22% decline from the prior-year quarter, primarily due to lower research and development expenses. The company recorded a GAAP net loss of $16.6 million, compared with a net loss of $56.6 million a year earlier. Its non-GAAP adjusted net loss was $16.3 million, compared with $28.7 million in the second quarter of 2025. In June, ADC Therapeutics announced a strategic reorganization that included a workforce reduction of approximately 17% and additional operational efficiencies. The company expects the actions to generate about $10 million in annualized cost savings while maintaining its commercial footprint for ZYNLONTA in third-line-plus DLBCL. Cash and cash equivalents totaled $219.1 million at June 30, down from $231 million at March 31, primarily because of cash used in operations. The company said its cash runway is expected to extend at least into 2028. Since receiving accelerated approval in 2021, ZYNLONTA monotherapy has been used to treat approximately 5,000 patients in the United States, according to Mallik. Management said it expects the therapy’s current commercial performance to remain stable and sees potential growth beginning in 2027 through expansion into earlier DLBCL treatment lines and indolent lymphomas. ADC Therapeutics SA is a clinical-stage biopharmaceutical company focused on the discovery and development of highly targeted antibody-drug conjugates (ADCs) designed to treat hematological malignancies such as non-Hodgkin lymphoma and acute myeloid leukemia. By marrying the specificity of monoclonal antibodies with potent cytotoxic payloads, the company aims to maximize tumor cell eradication while limiting off-target toxicity. At the core of ADC Therapeutics' portfolio is loncastuximab tesirine-lpyl, a CD19-directed ADC that received accelerated approval from the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "ADC Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Net Product Revenue: $18.6 million in Q2 2026, compared to $18.1 million in Q2 2025. Product Sales: $2.3 million for Q2 2026 and $6 million for the six months ended June 30, 2026, versus $0.8 million and $2.9 million in the same periods of 2025. Total Operating Expenses: $44.7 million for Q2 2026; adjusted operating expenses were $37.2 million, down 22% year-over-year. Net Loss (GAAP): $16.6 million for Q2 2026, compared to a net loss of $56.6 million in Q2 2025. Adjusted Net Loss (non-GAAP): $16.3 million for Q2 2026, versus a net loss of $28.7 million in Q2 2025. Cash Position: $219.1 million in cash equivalents as of June 30, 2026, compared to $231 million as of March 31, 2026. Cost Savings: Approximately $10 million in annualized savings from a strategic reorganization, including a 17% workforce reduction. Warning! GuruFocus has detected 5 Warning Signs with ADCT. Is ADCT fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. ADC Therapeutics SA (NYSE:ADCT) reported Q2 2026 net product revenues of $18.6 million, slightly up from $18.1 million in Q2 2025, indicating stable commercial performance for Zynlonta in third-line plus DLBCL. The company completed enrollment of 100 patients in the LOTUS-7 trial, with data suggesting the Zynlonta plus glofitamab combination is the most compelling in second-line DLBCL, potentially positioning it as a best-in-class therapy. ADC Therapeutics SA (NYSE:ADCT) plans to submit for breakthrough therapy designation for the LOTUS-7 combination and is exploring a Phase 3 pathway, which could expand Zynlonta's use into earlier lines of therapy. The company reduced operating expenses by 22% year-over-year on an adjusted basis and implemented a strategic reorganization expected to save approximately $10 million annually, improving financial efficiency. ADC Therapeutics SA (NYSE:ADCT) ended Q2 2026 with a healthy cash balance of $219.1 million, providing a cash runway at least into 2028 to support key clinical and regulatory activities. The company is advancing multiple pipeline opportunities, including updated data for marginal zone lymphoma and follicular lymphoma, with potential for breakthrough designation in MZL, broadening Zynlonta's addressable market. The FDA expressed substantial concerns regarding the benefit-risk profile of the LOTUS-5 trial, which met its primary endpoint of progression-free survival, casting uncertainty on the regulatory path for full approval of Zynlonta plus rituximab. ADC Therapeutics SA (NYSE:ADCT) is reassessing the regulatory strategy for LOTUS-5, with no clear timeline for resolution, potentially delaying label expansion into second-line DLBCL. The LOTUS-5 trial observed grade 5 infections, primarily bacterial, which were not mitigated by prophylaxis, raising safety concerns that could impact the drug's perception and adoption. The company's strategic reorganization included a 17% workforce reduction, which may affect operational capacity and morale, despite cost savings. ADC Therapeutics SA (NYSE:ADCT) faces a competitive and evolving DLBCL landscape, and the delay in LOTUS-5 regulatory progress could allow competitors to gain market share in earlier lines of therapy. The company's net loss, while improved, remains significant at $16.6 million for Q2 2026, and the reliance on pipeline success for future growth carries inherent clinical and regulatory risks. Q: Given the FDA's concerns regarding the benefit-risk profile of the LOTUS-5 trial, was there any discussion about maintaining the current accelerated approval status for Zynlonta?A: Ameet Mallik, CEO, clarified that the FDA's feedback was specific to the LOTUS-5 trial combination of loncastuximab tesirine plus rituximab, not the single-agent therapy. He confirmed the company remains confident that the monotherapy will stay on the market with its accelerated approval and is committed to working with the FDA to satisfy full approval requirements, either through LOTUS-5 or another study. Q: Have you seen the final ASH presentation data for LOTUS-7, and do your comments about compelling efficacy and consistent safety pertain to that final dataset?A: Ameet Mallik, CEO, confirmed that the abstract submitted for ASH contains the vast majority of the 100 enrolled patients. He stated that the belief in the compelling efficacy and safety data is reflective of that abstract, though he could not share all details due to disclosure reasons. Q: Regarding the exploration of a Phase 3 pathway for the LOTUS-7 combination, is this being pursued with Roche or independently?A: Ameet Mallik, CEO, declined to comment on specifics but noted the strong partnership with Roche. He stated the company has been preparing different design options for a potential Phase 3 trial, plans to file for breakthrough designation this year, and will discuss the path forward with the FDA. Q: Can you provide more detail on the type of grade 5 infections observed in LOTUS-5, and would they have been mitigated by the prophylactic and vaccination strategies now incorporated in LOTUS-7?A: Ameet Mallik, CEO, stated that the primary type of infections were bacterial, which is why the company believes prophylaxis could play a role. He emphasized the significant protocol differences between LOTUS-5 and LOTUS-7, with the latter recommending prophylaxis including vaccinations for viral, fungal, and bacterial infections. Q: How do you think about the potential read-through from the LOTUS-5 grade 5 signal to potential NCCN Compendia inclusion and adoption of the Zynlonta plus glofitamab combination?A: Ameet Mallik, CEO, stated there is no read-through between LOTUS-5 and Compendia inclusion as they are two very different studies with different regimens and protocols. He referenced prior disclosures showing a low percentage of grade 5 events (approximately 4%) in the LOTUS-7 data from December, indicating a difference between the studies. Q: Did the FDA provide any indication of what an effective path forward might look like for the Phase 3, and what strategies are you considering?A: Ameet Mallik, CEO, explained that during the pre-sBLA meeting, the FDA shared concerns typical of such meetings. The company is now assessing whether additional data, risk management options, or modifications to the potential label can address the FDA's concerns, which forms the basis of evaluating the path forward for LOTUS-5. Q: Did you see any changes in patient starts, unit demand, dosing, or physician prescribing behaviors following the LOTUS-5 disclosure? Also, did the FDA focus on PFS in patients 75 or older?A: Ameet Mallik, CEO, confirmed that Q2 sales were consistent with prior quarters with no impact from the disclosure, as the monotherapy has an established place in the third-line plus DLBCL setting. He noted that older patients with infections may benefit from prophylaxis, but emphasized that each study is independent and there is no read-through from LOTUS-5 to other studies or the current indication. Q: Can you provide any color on the timeline for the Phase 3 plans for LOTUS-7, given it appears to be more of a future focus?A: Ameet Mallik, CEO, stated it is premature to discuss timing and cost while still gathering input from the medical community and collaborating with the FDA on a final design. He emphasized that the company is pursuing the LOTUS-5 regulatory path and the LOTUS-7 breakthrough designation and Phase 3 exploration in parallel. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

LAUSANNE, Switzerland, Aug. 6, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that it will host a conference call and live webcast on Thursday, August 13, 2026, at 8:30 a.m. EDT to report financial results for the second quarter of 2026 and provide operational updates. To access the conference call, please register here. The participant toll-free dial-in number is 1-800-836-8184 for North America and Canada. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA® (loncastuximab tesirine-lpyl). ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: whether future LOTIS-7 results will be consistent with or different from the prior disclosure, the timing, results and publication of the full LOTIS-7 trial; the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission and acceptance of an sBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA® as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA® in the United States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and impact of such options; our expected cash runway into at least 2028; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's clinical trials; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACTS:Investors and MediaNicole RileyADC [email protected]+1 862-926-9040 View original content to download multimedia:https://www.prnewswire.com/news-releases/adc-therapeutics-to-host-second-quarter-2026-financial-results-conference-call-on-august-13-2026-302844068.html

Alkermes (ALKS) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to earnings of $0.52 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +100.00%. A quarter ago, it was expected that this drugmaker would post a loss of $0.57 per share when it actually produced a loss of $0.4, delivering a surprise of +29.82%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Alkermes, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $496.01 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 9.26%. This compares to year-ago revenues of $390.66 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Alkermes shares have added about 88.5% since the beginning of the year versus the S&P 500's gain of 8.3%. While Alkermes has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Alkermes was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.01 on $472.48 million in revenues for the coming quarter and -$0.42 on $1.81 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. ADC Therapeutics SA (ADCT), another stock in the same industry, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.19 per share in its upcoming report, which represents a year-over-year change of +62%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. ADC Therapeutics SA's revenues are expected to be $20.15 million, up 7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alkermes plc (ALKS) : Free Stock Analysis Report ADC Therapeutics SA (ADCT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Company to host conference call today at 4:30 p.m. EDT LAUSANNE, Switzerland, June 3, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT) today announced topline data from its Phase 3 LOTIS-5 confirmatory trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). ZYNLONTA plus rituximab achieved statistical significance on the trial's primary endpoint of progression-free survival (PFS) and demonstrated no detrimental effect on the key secondary efficacy endpoint of overall survival (OS). In addition, a higher complete response (CR) rate and duration of CRs (DoCR) were observed with ZYNLONTA plus rituximab. Overall, treatment emergent adverse event (TEAE) rates were similar between arms. Similar rates of overall Grade ≥3 TEAEs greater than 5% were observed across both arms, with hematologic TEAEs higher in the control arm and infection, hepatotoxicity, and edema/effusion higher in the test arm. Serious adverse events (SAEs), TEAEs leading to study drug withdrawal, and Grade 5 events were higher in the test arm, with the majority of Grade 5 TEAEs in the test arm occurring in patients aged 75 years or older. "In the context of a positive study, based on the totality of the data, we plan to discuss the benefit-risk profile of this combination with the U.S. FDA as we prepare for the planned supplemental Biologics License Application (sBLA) filing," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We would like to extend our thanks to the patients, investigators, and clinical teams who contributed to this important trial." The LOTIS-5 trial is a randomized, open‐label, two‐arm, multicenter study evaluating ZYNLONTA plus rituximab versus the standard immunochemotherapy rituximab gemcitabine‐oxaliplatin (R‐GemOx), for the treatment of r/r DLBCL after one or more lines of systemic therapy. The study met the primary endpoint of PFS (per independent review committee) with statistical significance (HR = 0.73; p-value = 0.008 two sided), with a median PFS of 6.1 months for ZYNLONTA plus rituximab vs 4.7 months for R-GemOx. Overall survival showed no detrimental effect with ZYNLONTA plus rituximab compared to the control arm (HR = 0.96, impacted by the earlier use and a higher rate of new anti-lymphoma treatment switching in the control arm). Overall response rate (ORR) was 58.1% vs. 45.2%, CR rate was 39.5% vs. 26.7%, median duration of response (DOR) was 9.2 months vs. 7.7 months, and median DoCR was 16.8 months vs. 12.3 months for ZYNLONTA plus rituximab compared to R-GemOx, respectively. Of patients achieving CR, 48.5% vs. 16.7% remained in CR at 24 months in favor of ZYNLONTA plus rituximab. Of note, results in North America were consistent with the overall study results. Overall, TEAE rates were similar between arms (98.5% vs. 97.5%). Higher rates of SAEs were seen in the test arm (49.0% vs. 34.5%). Grade ≥3 TEAEs observed in > 5% of patients were hematologic (40.7% vs. 59.4%), followed by infection/infestations (24.5% vs. 15.7%), then hepatotoxicity (17.2% vs. 8.1%) and oedema/effusion (7.4% vs. 0.5%) when comparing ZYNLONTA plus rituximab to R-GemOx. A higher rate of Grade 5 TEAEs was observed in the ZYNLONTA plus rituximab arm (27 pts/13.2%) vs. R-GemOx (9 pts/4.6%). Of note, the majority of Grade 5 TEAEs in the test arm occurred in patients aged 75 years or older. Higher rates of TEAEs leading to any drug withdrawal occurred in the ZYNLONTA plus rituximab arm (25.5% vs. 9.1%). In this study, the TEAE reporting window was defined as 105 days after the last dose of study treatment or the start of new anticancer therapy, whichever is earlier. The rates of TEAEs in this study were impacted by the longer overall TEAE observation time in the test vs. control arm. This difference is primarily driven by a higher rate of and earlier switching to subsequent therapies in the control arm. "LOTIS-5 was designed to address a clear unmet need in r/r DLBCL in patients who cannot access or who progress on a CAR-T or other complex therapies," said Mehdi Hamadani, MD, Professor of Medicine, Associate Director of Clinical Research, Section Chief of Hematologic Malignancies at Medical College of Wisconsin and principal investigator for the trial. "Based on these results, I believe this combination may provide an additional option in treating relapsed or refractory DLBCL." "Based on these topline results from LOTIS-5, we look forward to discussing next steps for this combination of ZYNLONTA plus rituximab with the U.S. FDA," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We intend to conduct a pre-sBLA meeting in August and are preparing for a planned sBLA submission in the fourth quarter of 2026." In addition, the Company will continue to evaluate a broad range of value maximizing alternatives, including but not limited to near-term cost reduction initiatives. For more information about LOTIS-5, please visit https://clinicaltrials.gov/ (identifier: NCT04384484). Conference Call Details ADC Therapeutics management will host a conference call and live audio webcast to discuss the LOTIS-5 results today at 4:30 p.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call. About ZYNLONTA®ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com. ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA® (loncastuximab tesirine-lpyl). ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA; the timing, submission and acceptance of an sBLA submission related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA in the United States and foreign jurisdictions; our ability to identify and execute value-maximizing options and the cost and impact of such options; our expected cash runway into at least 2028; our ability to comply with the terms of our indebtedness; changes in our regulatory and commercial strategy; the Company's ability to sustain or grow ZYNLONTA® revenue in the United States and potential peak revenue; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing, results and publication of the Company's clinical trials including LOTIS-7; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACTS: Investors and Media Nicole Riley ADC Therapeutics [email protected] +1 862-926-9040 View original content to download multimedia:https://www.prnewswire.com/news-releases/adc-therapeutics-announces-results-from-lotis-5-phase-3-confirmatory-clinical-trial-of-zynlonta-in-combination-with-rituximab-in-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-302790606.html

Management attributes the 15% year-over-year revenue growth primarily to normal customer ordering variability rather than a fundamental shift in market demand, which remains broadly stable. ZYNLONTA is positioned as a differentiated treatment for third-line plus DLBCL, characterized by rapid and durable efficacy with a manageable safety profile and convenient administration. The company is executing a life cycle management strategy to expand ZYNLONTA into earlier lines of therapy and indolent lymphomas, targeting peak U.S. annual revenues of $600 million to $1 billion. Operational efficiency improved through a 13% reduction in non-GAAP operating expenses, driven by lower R&D spending and disciplined capital allocation. Management believes the stability of product revenues over multiple quarters validates ZYNLONTA's established role in a highly competitive market environment. Strategic focus is shifting from research and development toward commercial manufacturing activities, reflected in the reallocation of certain personnel costs. Top-line data for the LOTIS-5 Phase III confirmatory trial is expected before the end of June 2026, which serves as the primary near-term value catalyst. Management anticipates an accelerated revenue growth trajectory starting in 2027, contingent upon positive clinical readouts and subsequent regulatory approvals. The company expects to submit a supplemental Biologics License Application (sBLA) for LOTIS-5 by year-end 2026, with potential compendia inclusion in the first half of 2027. Full data from the LOTIS-7 trial and various investigator-initiated trials in indolent lymphomas are anticipated between late 2026 and mid-2027. The current cash balance of $231 million is projected to support operations at least into 2028, providing a stable runway to reach upcoming clinical milestones. Cost of product sales increased due to a strategic shift in personnel allocation from R&D to commercial manufacturing, a trend expected to continue in future quarters. The company has entered a 'blackout period' regarding LOTIS-5 data, resulting in the cancellation of certain investor and analyst engagements until top-line results are disclosed. Future revenue projections for ZYNLONTA assume both successful regulatory approval and favorable compendia listing for new indications. Management noted that while recent revenue was strong, it is too early to call a definitive change in the long-term sales trend due to historical variability. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management confirmed they remain completely blinded to the data and did not specify if the 262-event threshold has been reached. The company is on track to lock the database, perform statistical analysis, and share top-line results within the second quarter of 2026. The top-line announcement will include primary endpoints such as median PFS and hazard ratios, along with key secondary endpoints and safety data. More granular sub-analyses will be reserved for medical conferences and formal publications later in the year. No immediate revenue impact is expected in 2026 following the LOTIS-5 readout; promotion will only begin after formal approval, likely in mid-2027. Compendia inclusion for LOTIS-5 is targeted for the first half of 2027, which typically precedes full regulatory approval. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Image source: The Motley Fool. Monday, May 4, 2026 at 8:30 a.m. ET Chief Executive Officer — Ameet Mallik Chief Financial Officer — Jose Carmona Head of Investor Relations — Nicole Riley Need a quote from a Motley Fool analyst? Email [email protected] Nicole Riley: Thank you, operator. Today, we issued a press release announcing our first quarter 2026 financial results and business updates. This release and the slides we will use in today's presentation are available on the Investors 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 Financial Officer, Pepe Carmona, who will review our first 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 first 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: Thank you, Nicole. We continue to make good progress in the first quarter of 2026 as we advance towards multiple important milestones for ZYNLONTA over the remainder of the year, beginning with the expected LOTIS-5 top line readout in the second quarter. From a commercial perspective, we continue to focus on execution and delivering on our commercial strategy, maintaining ZYNLONTA as a differentiated treatment option for third-line plus DLBCL patients. First quarter net product revenues were $20.0 million as compared to the prior year's first quarter net product revenues of $17.4 million. The increase was driven primarily by normal quarter-to-quarter variability in customer ordering with underlying demand broadly stable. Looking toward the second line plus setting where we believe the largest growth opportunity lies. For LOTIS-5, our Phase III confirmatory trial of ZYNLONTA plus rituximab, we expect to share top line data before the end of June, potentially bringing us another step closer to providing this combination to significantly more patients. While this time line is rapidly approaching, I do want to highlight that we are currently still blinded to the data. Turning to LOTIS-7. We expect to complete enrollment of approximately 100 patients at the selected dose level of ZYNLONTA plus glofitamab in the second quarter with full data anticipated by year-end. In indolent lymphomas, we continue to anticipate data publication between the end of 2026 and mid-2027 from the multicenter investigator-initiated trials ZYNLONTA in combination with rituximab to treat relapsed or refractory follicular lymphoma and of ZYNLONTA as a monotherapy to treat relapsed or refractory marginal zone lymphoma. We continue to pay close attention in the quarter to managing our cost base and optimizing our balance sheet. On a non-GAAP basis, we've reduced our total operating expenses by 13% versus Q1 2025, and we ended the first quarter of 2026 with a healthy cash balance of $231 million. This maintains our expected cash runway at least into 2028, enabling us to deliver against our strategy. We are building off the well-established role of ZYNLONTA as a single-agent therapy in third line plus DLBCL where ZYNLONTA has a profile of rapid, deep and durable efficacy, as well as manageable safety with simple and convenient administration. We believe the relative stability we've seen in net product revenues over multiple quarters demonstrates that ZYNLONTA has a clear place in this market. This is just a starting point as we believe in the potential for ZYNLONTA to reach significantly more patients by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas. The data we've seen across these settings so far have been consistently encouraging with the potential to be highly differentiating. Through expansion into these settings in DLBCL and into indolent lymphomas, we are confident that ZYNLONTA has the potential to reach peak annual revenues of $600 million to $1 billion in the U.S., assuming both compendia listing and regulatory approval. The upcoming LOTIS-5 trial readout, if positive, we'll begin to unlock the value of our life cycle management efforts with ZYNLONTA. Taken together with the upcoming data expected from LOTIS-7 and the indolent lymphoma studies, we expect to accelerate our revenue growth trajectory starting in 2027. Now I would like to turn the call over to Pepe Carmona, our CFO, who will discuss financial results for the first quarter. Pepe? Jose Carmona: Thank you, Ameet. On the financial front, ZYNLONTA net product revenues in the first quarter of 2026 were $20 million as compared to $17.4 million in the same quarter in 2025. Licensing revenues and royalties were lower this year due to $5 million milestone we received from our partner in the prior year period. Cost of product sales increased by $1.6 million to $3.6 million for the 3 months ended March 31, 2026. This increase reflects a shift in the allocation of certain personnel costs due to a change in focus from research and development activities to commercial manufacturing activities. Total operating expenses were $46.1 million for the first quarter. On a non-GAAP basis, total adjusted operating expenses were $42.9 million for the quarter. Total adjusted operating expenses were down by 13% over the prior year period, primarily driven by lower R&D expenses. As Ameet noted, when managing our costs carefully, and we remain disciplined in our capital allocation towards potential value creation while driving efficiency. On a GAAP basis, we reported a net loss of $33 million for the first quarter of 2026 or $0.21 per basic and diluted share as compared to a net loss of $38.6 million or $0.36 per basic and diluted share for the same period in 2025. On a non-GAAP basis, the adjusted net loss was $19.7 million for the first quarter of 2026, as compared to a net loss of $24 million for the same period in 2025. The lower net loss on both GAAP and non-GAAP basis was primarily due to reduced R&D expenses. The year-over-year reductions 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 first quarter in the compounding financial tables of the press release issued earlier today and in the appendix of this presentation. At the end of the first quarter, we had cash and cash equivalents of $231 million as compared to $261.3 million as of December 31, 2025. This provides us with an expected cash runway at least into 2028. Turning to upcoming milestones. We expect to have multiple data catalysts during the remainder of 2026 across the ZYNLONTA program. First, we expect to share the top line data for LOTIS-5 before the end of June with publication of full results anticipated by the year-end. As Ameet noted, we're currently blinded to the data. Until the top line data has been presented, we will remain in a blackout period, which means we may need to cancel our participation in any conferences as well as meetings with investors and analysts. Assuming the results are positive, we plan to submit a supplemental biologics license application to the FDA by year-end, with potential publication and compendia inclusion in the first half of 2027 and confirmatory approval to follow thereafter. With LOTIS-7, we are on track to complete enrollment in the second quarter. We plan to share the next update with full data at a medical meeting by the end of 2026. In addition, assuming positive results, we plan to pursue compendia inclusion as well as assess our regulatory strategy. With indolent lymphomas, we expect the lead investigator to share additional data at medical conferences between the end of 2026 and mid-2027, and we plan to assess regulatory and competing strategies once sufficient data are available. I will now turn the call back over to Ameet. Ameet Mallik: Thank you, Pepe. To close, I am pleased with our start to 2026. We have achieved solid commercial performance while maintaining our strict capital discipline as we look forward to multiple anticipated value-creating catalysts, beginning with the expected LOTIS-5 readout. We are excited about delivering on our strategy and confident we can drive significant potential long-term growth starting in 2027. We can now open the line for questions. Operator: [Operator Instructions] Your first question comes from Maury Raycroft with Jefferies. Maurice Raycroft: Congrats on the progress. You mentioned on the call that you remain blinded to the data. Can you clarify if the database is locked at this point and when you reach the 262 events? And from a process standpoint, can you say what's happening currently? And what are the drivers that will allow you to unblind the data? Ameet Mallik: Yes. Thanks for the question. So what I can tell you is we're on track to be able to read the data. So the -- we're completely blinded to the data side. I don't know any information yet. But as soon as the database gets locked and we do the statistical analysis, we'll then be able to disclose top line data. So we're not at that point yet. But we are on track to basically to share the data this quarter. Maurice Raycroft: Got it. Okay. And for when you reach the 262 events, is there anything more on that you're saying? From a timing perspective? Ameet Mallik: Yes, we're not commenting on exactly where we're going to the events. But what I can tell you is we're on track to hit the -- to basically to get to the top line results this quarter in the second quarter. Maurice Raycroft: Okay. Understood. Maybe one other quick question. Just following the site level interventions you implemented to address the early dropout in censoring, do you have any perspective potentially from the IDMC to provide any indication that sensoring rates improved after those changes? I guess any -- any more color on that could be helpful. Ameet Mallik: I can't comment further. What I can tell you is the last IDMC look, which is from a safety standpoint, was last fall. And again, that recommendation wants to proceed as it is. There's been -- any other looks from the IDMC at the data. Operator: Next question comes from Michael Schmidt with Guggenheim. Michael Schmidt: I have a couple. Maybe first commercially, the $20 million in 1Q, it's about 15% growth annually. I know you mentioned ordering pattern, but it just seems more growth than we've seen in recent quarters. And just curious if there's anything else going on in terms of driving more volume perhaps in the approved indication in the market? And then the other question I just had on LOTIS-5, so great to hear that the data is still on track for this quarter. Could you just comment on how much of the result, you'll be able to disclose in the top line announcement? Will you be able to share things like median PFS or perhaps asset ratios, et cetera, in the top line release? Ameet Mallik: Yes. Thanks, Michael. So first, on sales, as you recall, Q3 was quite low and the Q4 was quite strong. So we had $16.8 million, the $22.3 million, now we're at $20 million. I think it's too soon to call a change in trend, to be honest right now. But I think what we're seeing is definitely very good execution. We're happy that we've been able to maintain our share despite a very competitive environment. And there is quarter-to-quarter variability as we saw in the Q3 was one of the lowest quarters in the Q4 is one of the higher quarters in the last couple of years. But I think after 2 quarters in that $20-plus million range, it's encouraging, but too soon to call the trend. So I think if this continues, that may cause us to sort of change where we think the range is going to be. But I think at this point, just given the variability that we've seen in the last couple of years, I think -- we think it's -- we're still in the range of normal demand within the content of custom order variability. With regards to LOTIS-5, we plan to share all the relevant information on the primary endpoints, of course, the median PFS, hazard ratio, any information that we have on key secondary endpoints as well as top line safety data. So we do want to make sure that the disclosure is clear with the information that we have and well understood what the result is. At the same time, a lot of sub analyses and other things that are typically less relevant for top line results, but critical for, let's say, a medical conference or publication. Those would be details that would come later in the year. Operator: Your next question comes from Eric Schmidt with Cantor. Eric Schmidt: A couple of questions for me also on LOTIS-5. First, with regard to procedures. Do I take that base comments to mean that you're now entering the quiet period? Is that starting after today? Ameet Mallik: We started actually a quiet period, we have to do earnings, of course, but we haven't been engaging with analyst or investors since April 1. So for the whole quarter until we disclose the data. Eric Schmidt: And then Ameet, on the information that you'll be able to disclose with regard to the top line data for LOTIS-5 this quarter. Will we get some thoughts on how survival is trending? I know the trial's primary endpoint is PFS and you're well powered there. But wondering if you'll be able to provide color on OS trends. And then if you know at this point, how many OS events or how mature the OS data might be at the time of the PFS top line look? Ameet Mallik: Yes. So in addition to TFS, which obviously will be mature, we will give the information that we have on overall survival. So whether it's mature or it's a trend, we will provide the information that we have on overall survival as well as the other key secondary endpoints as well like response rate, duration of response. So we plan to share all the information we have. I can't comment right now on how many events we have with regards to overall survival. But what I can tell you is it will be -- with whatever information we have, we will make a part of the disclosure. Eric Schmidt: And then maybe just one modeling it for Pepe. The change that we saw from personnel from R&D into cost of goods. Is that an ongoing transition? Are we expecting COGS to be inflated in subsequent quarters as well? Jose Carmona: It is going to continue throughout all quarters from now on. So it's a reallocation of those expenses into cost of goods, and we capitalize on time inventory, but the cost of goods are going to increase because of this fixed cost and now it's getting allocated. Operator: [Operator Instructions]. Your next question comes from Sudan Loganathan with Stephens. Sudan Loganathan: My first one, I wanted to ask what -- what you believe the immediate impacts post the LOTIS-5 top line results in the second quarter could be, for instance, if it is positive, good PFS readout, how this may change of ZYNLONTA is prescribed reviewed in the second half of this year, even prior to complete listing? And then secondly, I just wanted to ask, even push over to the IITs, how does that add some incremental value over the next year or 2? Ameet Mallik: Sure. Yes. So once we get to the top line readout, assuming it's positive, we then would work to kind of go down too fast. One is to prepare the sBLA submission that typically 4 to 5 months, we expect to have that certainly before the end of this year. And then that could lead to our approval thereafter next year. And then in addition, we plan to submit to a medical congress and publication by the end of this year. to share the full details as a result, that would be the basis that we would submit to compendia. So we expect that we could get compendia inclusion sometime in the first part of next year and then an approval sometime thereafter in 2027. So we don't expect any revenue impact this year. We expect this year to be largely in line with what the previous years are and only see revenue trajectory increase next year as we'll only start promoting the product once we have a formal approval sometime around the middle of next year. And your second question was around the IITs, correct? Sudan Loganathan: Yes. Yes. Ameet Mallik: Okay. So with the IITs, we have both marginal zone and follicular lymphoma IITs. Both of those -- let's call it the data on the full study will be disclosed sometime between the end of this year and the middle of next year. We expect publications to happen around that same time and then to be submitted for compendia inclusion after that. In addition, we're evaluating the regulatory approach for , but we would taking in lymphomas when we move forward in parallel. Operator: There are no further questions at this time. I will now turn the call over to Ameet Mallik for closing remarks. Ameet Mallik: Thank you all for joining the call today and for your continued support. We look forward to keeping you updated on our progress and look forward to speaking to you soon. Operator, you may now end the call. Thank you. Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Before you buy stock in Adc Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Adc Therapeutics wasn’t one of them. 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