ADC Therapeutics SA Q1 FY2026 Earnings Call

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q1 2026 Earnings Conference Call. The operator provided instructions to participants. This call is being recorded on Monday, May 4, 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications. Please go ahead.

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

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 timeline 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 of 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, will begin to unlock the value of our lifecycle 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?

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 a $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 three 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, we are 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 accompanying 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 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 compendia strategies once sufficient data are available. I will now turn the call back over to Ameet.

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.

The operator provided instructions to participants. Your first question comes from Maury Raycroft with Jefferies.

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?

Yes. Thanks for the question. What I can tell you is we're on track to read the data. We are completely blinded to the data; I don't have 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 share the data this quarter.

Got it. Okay. And for when you reach the 262 events, is there anything more on that you're saying from a timing perspective?

Yes, we're not commenting on exactly where we stand on the event count. But what I can tell you is we're on track to obtain the top-line results in the second quarter.

Okay. Understood. Maybe one other quick question. Just following the site-level interventions you implemented to address the early dropout and censoring, do you have any perspective, potentially from the IDMC, to provide any indication that censoring rates improved after those changes? Any additional color on that could be helpful.

I can't comment further. What I can tell you is the last IDMC look, which was from a safety standpoint, was last fall. That recommendation was to proceed as planned. There haven't been any other looks from the IDMC at the data since then.

Next question comes from Michael Schmidt with Guggenheim.

I have a couple. Maybe first commercially, the $20 million in 1Q is about 15% growth annually. I know you mentioned ordering pattern, but it just seems more growth than we've seen in recent quarters. 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 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 hazard ratios, et cetera, in the top-line release?

Yes. Thanks, Michael. So first, on sales, as you recall, Q3 was quite low and Q4 was quite strong; last year we had $16.8 million in one quarter and $22.3 million in another quarter, and now we're at $20 million. I think it's too soon to call a change in trend right now. What we're seeing is very good execution. We're pleased that we've been able to maintain our share despite a very competitive environment. There is quarter-to-quarter variability; Q3 was one of the lower quarters and Q4 one of the higher quarters in the last couple of years. After two quarters in that $20-plus million range, it's encouraging, but too soon to call a trend. If this continues, it may cause us to adjust where we think the range will be, but at this point given the variability we've seen, we consider this within the range of normal demand and customer order variability. With regards to LOTIS-5, we plan to share all the relevant information on the primary endpoint, of course the median PFS and hazard ratio, any information that we have on key secondary endpoints, as well as top-line safety data. We want to make sure the disclosure is clear and that the information is well understood. A lot of subgroup analyses and other details that are typically less relevant for top-line results but critical for a medical conference or publication would come later in the year.

Your next question comes from Eric Schmidt with Cantor.

A couple of questions for me also on LOTIS-5. First, with regard to procedures, do I take those comments to mean that you're now in a quiet period? Is that starting after today?

We actually started the quiet period; we have to do earnings, of course, but we haven't been engaging with analysts or investors since April 1. So for the whole quarter up to when we disclose the data, we have limited engagement.

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 overall 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 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?

Yes. In addition to PFS, which obviously will be mature, we will provide the information that we have on overall survival. Whether it's mature or shows a trend, we will include whatever OS information we have, as well as other key secondary endpoints such as response rate and duration of response. I can't comment right now on how many OS events we have, but whatever information is available will be part of the disclosure.

And then maybe one modeling question for Pepe. The change that we saw with personnel moving from R&D into cost of goods— is that an ongoing transition? Are we expecting COGS to be higher in subsequent quarters as well?

It is going to continue throughout all quarters from now on. It's a reallocation of those expenses into cost of goods sold, and we will capitalize inventory over time, but cost of goods sold are going to increase because these fixed costs are now being allocated to manufacturing.

The operator provided instructions to participants. Your next question comes from Sudan Loganathan with Stephens.

My first question: what do you believe the immediate impacts post the LOTIS-5 top-line results in the second quarter could be? For instance, if it is positive with a good PFS readout, how might this change how ZYNLONTA is prescribed or reviewed in the second half of this year, even prior to complete listing? And secondly, I wanted to ask about the IITs—how does that add incremental value over the next year or two?

Sure. Once we get to the top-line readout, assuming it's positive, we would pursue two primary paths. One is to prepare and submit the sBLA; that process typically takes four to five months, and we expect to file before the end of this year. That could lead to approval thereafter next year. In addition, we plan to submit the data to a medical congress and for publication by the end of this year to share the full details; that disclosure would form the basis for submitting to compendia. We expect compendia inclusion sometime in the first part of next year and then potential regulatory approval sometime thereafter in 2027. We don't expect any material revenue impact this year; we expect 2026 revenues to be largely in line with previous years, and we expect revenue growth to accelerate next year, as we would only start broader promotion once we have formal approval, likely around the middle of next year. Regarding the IITs, we have both marginal zone and follicular lymphoma investigator-initiated trials. Data from the full studies will be disclosed sometime between the end of this year and the middle of next year. We expect publications around that same time and then submissions for compendia inclusion after that. In addition, we're evaluating the regulatory approach and would pursue regulatory pathways for lymphomas in parallel as we move forward.

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

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.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.