ADC Therapeutics SA

Good morning, ladies and gentlemen, and welcome to ADC Therapeutics First Quarter 2025 earnings call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a -and-answer session. If anyone has any difficulties hearing the conference, please press star zero for operator assistance at any time. I would not like to turn the conference call over to Marcy Graham, Investor Relations and Corporate Affairs Officer. Please go ahead.

Thank you, Operator. Today, we issued a press release announcing our

first quarter 2025 financial results and business updates. This release and the slides we will use in today's presentation are available on the Investor section of the ADC Therapeutics website. I'm joined on today's call by our Chief Executive Officer, Amit Malik, who will discuss our operational performance and recent business highlights. Our Chief Medical Officer, Mohamed Zaki, who will discuss our clinical programs and updates, followed by our Chief Financial Officer, Pepe Carmona, who will review our first quarter 2025 financial results. We will then open the call for 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 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 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, Amit Malik.

Amit? Thanks Marcy, and hello, Luan. Thank you for joining us on today's call. The first quarter of 2025 represented a solid period of continued performance for our company. Throughout the quarter, we continued to focus on execution and delivering on our commercial strategy, maintaining our place as a treatment option for third-line plus DLBCL patients. Total first quarter revenues were $23 million, which included net product revenues of $17.4 million. This is in line with the first quarter sales in 2024 and compares favorably to $16.4 million in the fourth quarter of 2024. We had an additional $5.6 million in milestone and royalty payments included in total revenue for the quarter. Additionally, as just announced this morning, we are pleased to have data from LOTUS 7 accepted for presentation at EHA, the European Hematology Association Congress, and at ICML, the International Conference on Malignant Lymphoma, both in June. We are encouraged by the promising LOTUS 7 EHA abstract data demonstrating the potential for Zinlanta plus Glofidimab to be a -in-class combination in a highly competitive market. For reference, we have seen complete response rates in other bi-specific combination trials in the range of 47 to 62 percent. Abstract data as of January 2025 shows Zinlanta plus Glofidimab demonstrated an overall response rate of 95.5 percent and a complete response rate of 90.9 percent in the 22 efficacy-evaluable patients with further updated data to be presented at the meeting next month. We have recent enrollment of 40 patients in our LOTUS 7 dose expansion arm and expect to share an additional update on LOTUS 7 in the second half of 2025. We are encouraged by the results we've reported so far and are assessing options for expanding enrollment to 100 patients at the recommended dose level, which will support regulatory discussions and is in line with recent examples of bi-specific combination therapies added to Compendia. Once sufficient data with longer follow-up is available, we plan to discuss the path forward for Zinlanta and Glofidimab with regulatory authorities and to pursue a Compendia strategy. LOTUS 5 remains on track to reach the pre-specified number of progression-free survival events by the end of 2025. After the pre-specified number of PFS events is reached and data are available, we expect to provide top-line data on this Phase III conservatory trial evaluating Zinlanta in combination with Botoximab and patients with Secondline Plus-DLBCL. Lastly, updated data from the Phase II IIT and Marginal Zone lymphoma being led by the Sylvester Comprehensive Cancer Center at University of Miami will also be presented at ICML. Moving beyond Zinlanta, the trial sponsored by the University of Texas MD Anderson Cancer Center evaluating ADCT602, which targets CD22, and patients with relapsed or refractory B-cell acute lymphoblastic leukemia is being discontinued based on available clinical data. I would like to thank the physicians and patients who participated in this trial. We were pleased to have data from preclinical studies of our exotecant-based ADCs targeting CLAWDN6, PSMA, and ASCT2 featured at the American Association for Cancer Research Annual Meeting last month. Here the most advanced targets are PSMA and CLAWDN6, and we continue to seek potential research collaborations to further advance our programs. I'm excited about the multiple upcoming catalysts ahead within our cash runway, which is expected to fund operations into the second half of 2026. As a single agent therapy and third line plus DLBCL, Zinlanta has a profile of rapid, deep, and durable efficacy, as well as manageable safety with simple and convenient administration. Beyond our current indication, we believe in the potential to reach significantly more patients while growing the commercial opportunity by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas. The data we've seen across these settings so far has been consistently encouraging with the potential to be highly differentiating. We know physicians make treatment choices based on efficacy, safety, and accessibility in the context of individual patient needs. We believe efficacy is the primary driver of decision making for treatments that are accessible and suitable for a given DLBCL patient. Zinlanta plus Rituximab in Lotus V and Zinlanta plus Glofidimab in Lotus VII offer distinct approaches to addressing unmet needs in patients with DLBCL. In Lotus V, we believe the combination of Zinlanta plus Rituximab may offer a competitive second line plus efficacy with a favorable safety and convenient dosing schedule for patients who cannot access or are not suitable for or progress on a CAR-T or bispecific based therapy. In Lotus VII, based upon the recent data we shared, we believe Zinlanta plus Glofidimab has the potential to be the preferred bispecific combination in second line plus DLBCL with highly competitive efficacy and a manageable safety profile. With sufficient data from these trials, we plan to pursue regulatory and compendia strategies. Now I will turn the call over to our Medical Officer, Mohamed Zaki, to provide an overview of the Lotus VII abstract data accepted for presentation at EHA and ICML next month. Mohamed?

Thank you, Amit. We are excited today to report updated results from the Lotus VII study, evaluating a six-duration combination of Zinlanta and Glofidimab in patients with relapsed refractive DLBCL. The primary endpoint is safety and durability with the second endpoint of efficacy, TK, and immunogenicity. As we discussed, those escalations were completed last year with early signs of antituber activity and no DLTs were observed. We are well into those expansions, having enrolled 40 patients with this combination at either the 120 or 150 micrograms per K dose levels of Zinlanta combined with the approved dose of Glofidimab. As we turn to the data, we are surely encouraged by the results thus far for this study. As described here, the baseline characteristics of the patients enrolled, including being refractive to prior therapy as well as antisocial prior therapy, are similar to those we have seen in other bi-specific combination trials. Turning to safety, no new safety signals were observed, and the combination was well-tolerated. The successes observed during the study were manageable and were consistent with the known age of the two agents. Only low-grade adverse events of CRS and TK were observed. Turning to the efficacy results, a .5% overall response rate was seen in the 22 patients who were available for efficacy, with 20 patients or .9% achieving a complete response based on organocritteria. All but one of those patients remained in complete response as of the data count. We believe the LUDAS7 results so far are exceptional compared to current and emerging therapies in the second line plus DLPCL. The impressive efficacy and manageable safety profile seen to date in this trial with the combination of Xanlanta and Glufidomab, two potent anti-cancer agents with unique mechanical action, is encouraging. The data reinforces our belief in the potential for the regimen to change the treatment paradigm for with aggressive lymphoma. Though we are limited in what we can speak to until the EHA embargo lifts, we look forward to providing a more comprehensive look at results from our LUDAS7 trial in June when updated data are shared during a post-deprecation at EHA and a subsequent oral presentation at ICML. We expect to host a corporate webcast to further discuss the data shared at that time. Now I will turn the call over to Pepi Carbanu, our CFO, who will discuss financial results for the first quarter. Pepi?

Thank you, Mohamed. On the financial front, the Xanlanta Net product revenues in the first quarter of 2025 were $17.4 million as compared to $17.8 million in the same quarter of 2024. Total revenues for the first quarter was $23 million, which includes the recognition of $5 million in licensing revenue related to a -Bio-BioBioXanlanta approval by Health Canada. The payment of the Myosin was received in the second quarter and not yet reflected in our cash and cash equivalence balance at March 31, 2025. Total operating expenses for the quarter were $49.1 million on a non-GAAP basis, representing a 5% net decrease over prior year, driven primarily by a reduction in SG&A. On a GAAP basis, we reported a net loss of $38.6 million for the first quarter of 2025, or 36 cents per basic and diluted share, as compared to a net loss of $46.6 million, or 56 cents per basic and diluted share, for the same period in 2024. The decrease in net loss of the quarter is primarily attributable to higher license revenues and royalties, as well as lower expenses. You can find the reconciliation of GAAP to non-GAAP measures in the companion financial tables of the press release issued earlier today and in the appendix of this presentation. As of March 31, 2025, cash and cash equivalents were $194.7 million compared to $250.9 million on December 31, 2024. This change was primarily driven by our net loss from operations for the quarter and was impacted by the timing of cash receipts and payments, including payment of the annual discarded drugs rebate, annual bonuses, and facing of milestones another partner reimbursements received in the second quarter of 2025. As we have highlighted today, we made significant progress in the first quarter. In 2025, we have several potentially de-riskings in long data catalysts, which we believe will unlock significant growth opportunities. In this quarter alone, we have key value driving milestones at upcoming medical meetings. This includes providing an update on lot of seven at the upcoming EHA conference with an NCOR oral presentation at ICML. We expect to host a corporate webcast to further discuss the data shared at that time. We also expect to have updated data from the MZL phase two investigator initiated trial to be shared by Dr. Losos from University of Miami at ICML. As we move forward, we also expect to present data on the 40 patients enrolled for our lot of seven trial in the second half of this year. Beyond this, we'll provide top line results from lot of five once the press specified number of PFS events is reached and data are available. We continue to progress our preclinical assets as shared at AACR and are engaged in discussions with potential partners. With an expected cash runway into the second half of 2026, I'm confident that ADC Therapeutics is well positioned to deliver on our catalysts and drive value creation for all our stakeholders. I will now turn the call back over to Amit.

Amit Bhandari Thank you, Pepe. I am pleased with how we are executing against our strategy and continue to be encouraged by the consistently promising Zanlanta data we are generating across our ongoing trials. We believe our revenue growth opportunity comes with expanded use of Zanlanta through regulatory approvals as well as inclusion and guidelines. And we are confident in the multiple pathways we have to achieve our peak revenue goal. We can now open the line for questions.

Operator? Operator Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one in a touch-down phone. Should you wish to cancel your request, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. Once again, that is star one. Should you wish to ask a question? Your first question is from Kelly Shape from Jeffries. Your line is now open.

Josefer Kelly Thank you. Good morning. Thanks for taking my questions. This is Josefer Kelly. Could you please provide some color and the follow-up time for the patients from the update today and also for the 18 patients who achieved a complete response last year? Any color and see our conversion time to durability will be great. Thank you.

Operator Okay, thanks for the question. You were asking about the follow-up time of the data that we showed in December as well as what the follow-up time is now with this latest update and any color on the conversion. So I'll turn that over to Mohammed to answer that first question. Mohammed Thank you. Josefer Kelly Yeah, the

patients that we're following up right now is according to the data, we're going into more assessment to be able to talk more into the durability of responses as we go forward. However, the high number of CR that we're seeing right now is very encouraging. It's actually considered a very strong biomarker for durability. So it's really too early to speak about durability or the degree of follow-up at this stage.

Yeah, but if you recall, in the Swimmer's plot that we showed in December, the longest patient was nearly a year, so close to a year. And obviously, this analysis is a couple months later. So you can just sort of interpolate that. But more data on the follow-up in Swimmer's plot will be coming at the presentation at EHA.

Operator Thank you. Appreciate it. And a follow-up if I may. So on the campaign strategy you mentioned you plan to engage with regulatory authorities, is it when you have data from 40 patients that are already enrolled or would you wait for 100 patients?

Josefer Kelly Yeah, we believe if you look at all the recent bi-specific combination examples, many were added to guidelines earlier this year as a preferred regimen. We believe we're going to need a publication including the approximate 100 patients with about a year of follow-up, just based on all the other recent examples. And we're currently assessing how

to pass that forward. Operator Very helpful. Thank you. Josefer Kelly Thank you.

Operator Thank you. Your next question is from Eric Schmidt from Canter. Your line is now open.

Eric Schmidt Thanks for taking my questions and congrats on a really nice update in terms of how these results are trending. Maybe just first, how many more patients should we expect to see at the conference itself, EHA?

Josefer Kelly Yeah, we've disclosed how many more, but obviously we've already indicated in this release that we have enrolled the 40 patients that we had discussed that we want to enroll already. So there'll obviously be more patients than the 22. We can't disclose the exact number because all the abstract, anything beyond what's in the abstract isn't barcode. So we don't want to risk that.

Eric Schmidt I think in the past you've said maybe 10 to 15 additional patients by the time of the EHA update relative to the December update last year. Is that still kind of ballparky?

Josefer Kelly Yeah, I'd say it's ballparky versus the December update.

Eric Schmidt Okay. And how are you thinking about the overall profile of the combination today? I mean, again, relative to the last update, you've got potentially one of the highest ever response rates and complete response rates we've seen, including in CAR T. Is it time to start thinking about this maybe as a more efficacious but equally safe combination? Is anything out there? Or do you still think that safety might turn out to be trending somewhat better than other combinations as well?

Josefer Kelly Yeah, so it's a great question. I mean, obviously from an efficacy standpoint, we think the data is very, very encouraging right now. If you look at all the other bi-specific combination trials data that's been out there, everything from phase one data to phase three data, the CR rates have been anywhere from 47 to 62% the best ever reported. And as you're aware, CAR T's are in the kind of mid-60s to low 70s in terms of CR rates. So if anything over 70% we think would be extremely differentiating from an efficacy standpoint. I think from a safety standpoint, as you can see in this data, we continue to see only low-grade CRS when I can, a manageable safety profile overall, low discontinuation we've disclosed in the past with this regimen. And I think more importantly than even those things is it's also the novel mechanism. If you look at a lot of the other bi-specific combinations, they're either combining chemo, which has some irreversible toxicities like neuropathy, or combining with polietuzumab, which has really become a mainstay front line. And some physicians are reluctant to retreat with polietuzumab in subsequent lines. And so the fact that we're a unique agent combining with a highly potent bi-specific like polifidamab, I think makes us a great combination partner.

All right, thank you very much. Thank you.

Thank you. Your next question is from Michael Schmidt from Guggenheim Securities. Your line is now open.

Hey, good morning guys. This is Rosian from Michael. Congrats on the data, Yihan. Thanks for taking our questions. So in regards to Lotus 5, I guess with the guidance of reaching PFS events by the end of 2025, do you still expect that top line data to be a 20-time event or is that going to be pushed to like an early 2026 data readout? And I guess along the lines of that, how much data can we expect from that top line? And I guess like in terms of data itself, what does the combination need to show in order to be competitive? I know the trials randomized against our genmox, but I'm curious on how you're thinking about potential branch marking against CAR-T regimens or STARGLOW.

Yeah, so in terms of the timing, we've always indicated this is a PFS-driven event trial, and so we have to hit the pre-specified number of PFS events before we can then cleanse the data, assess it, and then show the top line results. We still expect that those events to happen this year, but the data readout could happen end of this year or early next year, as we've indicated up to this point. We just want to make it clear that because it's PFS-driven, we can't control it, and it does take, as you know, probably two to three months to cleanse the data, do all the quality control, and so that could happen end of this year or early next year. So that's still similar timing to what we've disclosed in the past. Do you want to talk, Mohamed,

about her other questions? I'll

be very shamed. What do you need to achieve in order to be differentiated? Well, typically we have shown already in the 60 run-out 20 patient a 50% complete response and 80% overall response rate, and a PFS of 8.3 months. The trial design actually would be suggested that the trial be successful if we are actually two months stronger, four to six months. The control arm reads at four every six months. That's the hypothesis of the trial how it's designed and how it's powered. So we're very interested by the early data from the safety run-in, and we'll be sharing the top-line results, the outcome of the PFS of the study, and later on in a conference of publication, we'll be sharing more details

on

the outcome

of the study. Great. Thank you so much. Thank you.

Your next question is from Sidon Oligonofen from Stevens. Your line is now open.

Hi. Good morning. I'm Mohamed Enteppe. Thank you for the update. I'm glad to see the continued improvement with the Lotus 7 data as it matures. My first question is on the progress with the Lotus 5 and Lotus 7, and when we can expect maybe conversations with regulators to occur, are the communications with regulators necessary since we're going after this compendia listing strategy? And if you did have a meeting with FDA regulators, what can be gained from it for listing and going forward listing on guidelines?

Yeah. So I'll start then and turn it to Mohamed.

So

meeting with regulatory agencies isn't required to continue to expand at a dose that we decide to select on, but obviously for any regulatory path forward, it is absolutely critical. And so we're assessing different regulatory pathways forward, and I know Mohamed and the team plan to meet with regulatory agencies in the second half of this year, but maybe you can comment further on that. Yeah. We're

planning to meet with regulators second half of this year to address or discuss the dose in addition also to a potential path forward for regulatory path. Compendia is a different parallel pathway. As Amit mentioned, that's two different paths, but they're actually going to be going in parallel when we have the right amount of patients, the right amount of follow-up.

Great. I appreciate that. If I can squeeze in a second question real fast regarding the data pipeline development, I noticed the 602 program was discontinued. Does that free up capital to bring one of the exit TKAN based ADCs to the IND filing and even maybe initiating a phase one with the one that emerges? And is there still a goal to potentially outlicense or partner out one of those critical assets that emerges from those developments maybe later this year or early next year?

Yeah. I'm going to turn this to Pepe to address both the cost piece, 602 as well as where we stand with BD efforts on our research programs.

Yeah. Thanks for the questions. The 602 program was a program partnered with MD Anderson with basically the cost implications of that study of eliminating that study is very low. It's not part of, it's not a large portion of our capital allocation. The investment that we have right now is mostly associated with Zinlonta and then bringing the research platform to a certain point in which we believe those targets are partnerable. The progress on the research BD efforts is ongoing. We have done an exhaustive review with different strategic and financial partners and we will be providing updates in

the near term. Thank you. I appreciate the answers and the details and congrats again on the progress. Thank you. Thank

you. Your next question is from Gregory Renzel from RBC Capital Markets. Your line is open.

Good morning, team. It's Anishanth for Greg. Congrats on the progress this quarter and thanks for taking our questions. Just a couple from us. First with Lotus 7 being in the spotlight, we just wanted to get a sense on how the data to be presented at EHA and ICML would set the stage for data to come later on for the 40 patients in the dose expansion arm. And secondly, with Lotus 5, what should we be expecting on the parameters to be presented and even as a safety run-in? Are there any key efficacy benchmarks you could point us to? Thanks so much.

Okay, so you're really asking me about what's coming at EHA and ICML for both the Lotus 7 presentation as well as the Lotus 5 presentation. So I'll turn that to Mohamed who can give a little more detail on that.

Yeah, we will be actually presenting more patients and longer follow-up, but we cannot share any more details on the precision data in-bar release. We can only speak about what's in the abstract at this time. That's what we're going to say. With regards to Lotus 5, we'll be sharing a little bit more on the durability of complete responses that has been reaching more than two years now without reaching the median of the SCEAD or duration of response. That's technically what is planned to be shared as the abstract suggests, but pretty much the information we cannot share anymore because

of limbo. Yeah, and obviously as you saw in the press release for Lotus 7, it's a poster presentation at EHA. It's an oral presentation at ICML and it'll be a full data presentation, so you can expect

all

the typical

things you'd want to see in a full data presentation. Great, thank you. Thank

you. There are no further questions at this time. I will now hand the call back over to Amit Malik, CEO, for the closing remarks.

Well, I want to thank you all for joining our call today and for your continued support. We look forward to keeping you updated on our progress. The operator, you can now leave on the call. Thank you.

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may all disconnect your lines.