ADC Therapeutics SA

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Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q4 2025 Earnings Conference Call. At this time, all lines are in listen-only mode, and following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. I will now turn the call over to Nicole Riley, Head of Investor Relations and Corporate Communications for ADC Therapeutics. Nicole, please go ahead.

Thank you, Operator. Today, we issued a press release announcing our fourth quarter and full year 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, followed by our Chief Financial Officer, Pepe Carmona, who will review our fourth quarter and full year 2025 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 questions 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 fourth quarter full year 2025 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 Malek. Amit?

Amit Malek Thanks, Nicole, and hello, everyone. Thank you for joining us on today's call. We are pleased to share an update on our achievements in 2025 and our excitement for the future. Before I get into the details, I'd like to take a moment to reflect on the progress we've made over the past few years and why we believe this positions us strongly for the future. We have implemented a strategic plan to focus on Zenlanta with optimized lifecycle management. This includes advancing LOTUS 5, as well as initiating the bispecific combination study, LOTUS 7, and IITs and indolent lymphomas. By focusing the company, we reduced our operating cost structure by approximately 50%. At the same time, we refined our go-to-market model, which resulted in strengthened KOL advocacy and a sustained market position in the third line plus DLBCL setting, despite the entry of the bispecific class. Central to these achievements, we upgraded leadership and talent across the organization, which resulted in improved execution. Lastly, we strengthened our balance sheet through equity and BD and improved our strategic flexibility with an amended HCR agreement. Having set the strategic course for our company, we see three horizons for potential value creation. These are centered around final data disclosures, approval and companion inclusion, and ultimately delivering growth. As we advance across these horizons, our vision is to first establish Nalanta as a backbone therapy with a differentiated clinical profile across combinations and second-line plus DLBCL. Second, provide significant patient benefit in indolent lymphomas, including follicular lymphoma and marginal lymphoma. And third, achieve potential annual U.S. peak revenue opportunity of $600 million to $1 billion, assuming compendia inclusion and regulatory approval, with a highly leveraged cost structure, providing us with broader opportunities to invest in complementary hematology assets. 2025 was a year of substantial progress for our company. We further de-risked our portfolio with multiple exciting milestones achieved for key Zinlanta trials in both second-line plus DLBCL and through the indolent lymphoma IITs. We undertook a strategic reprioritization to focus resources on Zinlanta expansion opportunities. Positioning the company for long-term growth would significantly reduce operating expenses. And we significantly strengthened our balance sheet, providing us with the ability to deliver against our objectives. Among our accomplishments from a commercial perspective, we continue to focus on execution and delivering on our commercial strategy, maintaining Xenlanta as a differentiated treatment option for third-line plus DLBCL patients. Building off an unusually low Q3, performance was strong in Q4. with net product revenues of $22.3 million, primarily driven by variability in customer ordering patterns as well as activation of some new accounts. Sales for the year were $73.6 million and remain roughly stable in line with our expectations in the third line plus setting. Looking toward the second line plus setting where we believe the real growth opportunity lies, With Lotus 5, we expect to share top-line data in the second quarter of 2026, potentially bringing us another step closer to providing this combination treatment to significantly more patients. With Lotus 7, we expanded target enrollment to approximately 100 patients at the selected dose level and shared updated safety and efficacy data on 49 efficacy-evaluable patients in December. which we believe continues to support the potential for this regimen to be a best-in-class combination in a highly competitive market. In indolent lymphomas, promising phase two data was also shared in 2025 from the multi-center investigator-initiated trials of Xenlanta in combination with rituximab to treat relapsed or refractory follicular lymphoma, and of Xenlanta as a monotherapy to treat relapsed or refractory marginal lymphoma. with presentations at the International Conference on Malignant Lymphoma and the International Workshop on Non-Hodgkin Lymphoma. We anticipate publication of data across these IITs between the end of 2026 and mid-2027. Most recently, we were pleased to have entered into an amendment to our royalty purchase agreement with Healthcare Royalty. This update to the terms of our agreement is a reflection of ACR's conviction and the long-term value of Zimanta, and we believe these new terms give us greater strategic flexibility. Finally, from a corporate perspective, through strict capital management in 2025, including a strategic reprioritization and multiple financings, we ended the year with a cash balance of $261 million, with an expected cash runway at least into 2028. With this significant progress, we are confident in our path ahead as we work to make an impact for more patients moving forward. As a single-agent therapy and third-line plus BLBCL, Zinlata 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 by spanning 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 continue to believe that through expansion into these settings, DENLADA has the potential to reach peak annual revenues of $600 million to $1 billion in the U.S. Our current indication, as I noted earlier, has shown relative stability in net revenues over multiple quarters, demonstrating Zynlanta has a clear place in the market as a monotherapy. We believe Lotus 5 has the potential to lift peak annual revenue for Zynlanta to $200 million to $300 million as we expand into the second-line setting. Not only would this double the addressable patient population, but with an improved clinical profile versus our current indication as a monotherapy, we expect to gain share in the second line plus setting and improve duration of therapy. With Lotus 7, we estimate we can expand the total opportunity for Zinlanta in DLBCL to $500 million to $800 million in peak annual revenue with both regulatory approval and compendia listing. If the data continues to be compelling, we believe Zinlanta plus clofidamab has the potential to transform the future lymphoma treatment paradigm by becoming the preferred bispecific combination in the second-line plus DLBCL setting. On top of this, we see additional potential for Xanlanta in relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma. If the encouraging initial data in the Phase II IITs are maintained in larger patient numbers, We believe these indolent lymphomas could provide additional peak annual revenue for Zynlanta of 100 to 200 million with both regulatory approval and compendia listing, primarily driven by MZL. Let's drill down a little more into the specifics of the DLBCL treatment landscape to explain why we believe Zynlanta has the opportunity to play a significant role. In both the second and third line plus settings, there are two main segments. The first segment includes complex therapies which require unique infrastructure and expertise to handle logistical requirements and patient management. These are primarily confined to the academic centers and more sophisticated community centers and include therapies like CAR T, transplant, and bispecifics. The second segment comprises more broadly accessible therapies which all physicians can administer in the outpatient setting and include ADCs, monoclonal antibodies, and chemotherapy. The launch of bispecifics as monotherapy in the Third Line Plus setting has resulted in an evolution of the treatment landscape, where we estimate there's currently a 60-40 split between complex and broadly accessible segments. In the Second Line setting, where bispecifics have not yet been approved or added last year to NCCN guidelines for use in combination, we expect that they will continue to gain share and grow the use of complex therapies. Through Lotus 5 and 7, we believe Zynlanta combinations have the potential to raise the bar on efficacy in second-line plus DLBCL in their respective treatment segments, establishing Zynlanta as a backbone therapy with a differentiated clinical profile across combinations and offering complementary approaches to addressing unmet needs. In Lotus 5, our Phase III confirmatory study, we are combining Zynlanta with the most widely used agent, rituximab, in patients with second-line plus DLBCL. As a reminder, initial data from the safety lead-in portion showed an overall response rate of 80% and a complete response rate of 50% with no new safety signals, demonstrating that this combination has the potential to provide competitive second-line plus efficacy with a favorable safety profile, allowing broad accessibility. In LOTUS 7, our Phase 1b trial, We are combining Xylanta with the highly effective bispecific glufidamab in second-line plus patients. In December, we reported updated data from the trial, which demonstrated a 90% best overall response rate and a 78% complete response rate across 49 efficacy-available patients with a minimum of six-month follow-up. Not only did this support a clinically meaningful benefit for patients, but the data also showed the combination continues to generally be well tolerated with a manageable safety profile. Taken together, we are encouraged by the expanding dataset, which we believe demonstrates the potential for Zynlanta plus clofidimab to be a best-in-class combination in a highly competitive market. When you look at the CR rates across these two treatment segments, we believe the emerging clinical profiles Zynlanta plus clofidimab and Lotus 7 positions us well among complex therapies. And at the same time, the clinical profiles in Lantoplus rituximab and LOTUS-5 has the potential to differentiate us among broadly accessible therapies. Together, we believe these combinations have the potential to double the addressable patient population as we move into second line and increase the duration of therapy, moving on average from three cycles to five to six cycles. We have established a place for Zinlanta monotherapy today in later lines because it works quickly. CR is when achieved or durable, and it has manageable safety and a convenient dosing schedule. As compared to our current indication as a monotherapy, we believe an improved CR rate in a broader patient population with Lotus 5 will make Zinlanta more relevant among both academic and community treaters, especially for patients who cannot access, are not suitable for, or progress on a CAR-T or bispecific-based therapy. When you take into account the fact that there are approximately 12,000 patients in the second line, in addition to the approximately 6,000 in our currently addressable third line plus patient population, and the average number of cycles is an amount that would increase from approximately three to five, we believe that once in the second line setting, we will be positioned to reach more patients with additional cycles and will capture share accordingly. In the second-line setting, every 10 points of share translates to approximately $200 million in revenue, and every 10 points of share in the third-line plus setting to approximately $100 million, based on the expected longer duration of therapy for this combination. We have already achieved an approximately 10% share in the third-line plus setting as a monotherapy with a CR rate lower than that of competitive combination-based therapies. Therefore, if we maintain the 10% share we have today in the third-line plus setting, achieving only 5 to 10% share in the second-line setting would translate to roughly $200 to $300 million in peak sales opportunity for the Zonata plus rituximab combination alone. Taken together with the DLBCL five specific combination and indolent lymphoma opportunities, we believe we could deliver on our vision of a combined potential peak annual revenue of $600 million to $1 billion in the U.S., assuming compendia listings and regulatory approvals. Now, I will turn the call over to Pepe Carmona, our CFO, who will discuss financial results for the fourth quarter.

Pepe? Thank you, Amit.

On the financial front, Zinlanta net product revenues in the fourth quarter of 2025 were $22.3 million as compared to $16.4 million in the same quarter in 2024. On a full year basis, net product revenues were $73.6 million versus $69.3 million in 2024, with an underlying volume broadly flat. Total operating expenses were $41 million and $202.9 million for the fourth quarter and full year ended December 31st, 2025, respectively. On a non-GAAP basis, total adjusted operating expenses were $39.4 million and $181.3 million for the quarter and full year ended December 31st, 2025, respectively. Total adjusted operating expenses were down over prior year by 15% and 6% respectively. The reduction in total adjusted operating expenses for the fourth quarter was primarily driven by lower R&D expenses. The decrease in total adjusted operating expenses for the full year was across all major lines of the income statement. We continue to be disciplined in our allocation towards potential value creation while driving efficiencies across the portfolio. On a gap basis, we reported a net loss of $6.4 million for the fourth quarter of 2025, or 4 cents per basic undiluted share, as compared to a net loss of $30.7 million, or 29 cents per basic undiluted share, for the same period in 2024. Net loss for the full year ended December 31st, 2025 was $142.6 million or a net loss of $1.12 per basic undiluted share as compared to a net loss of $157.8 million or a net loss of $1.62 per basic undiluted share for the full year ended December 31st, 2024. The lower net loss over both periods was primarily due to a higher cumulative catch-up adjustment gain associated with our deferred royalty obligation and reduced R&D expenses, partially offset by a restructuring impairment and related costs incurred in connection with the strategic reprioritization and restructuring plans. You can find the reconciliation of GAAP to non-GAAP measures for the fourth quarter and year-to-date in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation. At the end of the quarter, we had cash and cash equivalents of $261.3 million compared to $250.9 million as of December 31st, 2024. We significantly strengthened our balance sheet in 2025 by entering into a $100 million pipe financing in June 2025 and a $60 million pipe financing in October 2025, providing an expected cash runaway at least into 2028. We expect to have multiple data catalysts in 2026 across the SYNLONDA program. For lots five, we expect to provide top-line data in the second quarter of 2026. We expect to publish full results by the year end. Assuming the results are positive, we'll file a supplemental biologic license application submission to the FDA with potential publication and compendia inclusion in the first half of 2027 and confirmatory approval to follow in mid-2027. With lot of seven, we plan to share the next update with full data at a medical meeting and through publication by the end of 2026. In addition, assuming positive results, we plan to pursue compendia inclusion as well as assess a regulatory strategy. With indolent informants, we expect additional data to be shared at medical conferences by the lead investigators 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 Amit.

Thank you, Pepe. To close, we achieved meaningful progress across our Dinanta Clinical Program and DLBCL, and through investigator-initiated trials in indolent lymphomas this past year. And we believe we have laid the foundation for multiple anticipated value-created catalysts ahead, as Pepe just highlighted. With a strengthened cash runway, we are confident we will drive significant potential long-term growth beginning in 2027. We can now open the line for questions. Operator?

Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. And if you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. And your first question comes from Murray Raycroft from Jefferies. Please go ahead.

Hi, good morning. Congrats on the progress and thanks for taking my questions. I'm going to ask one on Lotus 5. At a high level, how are PFS events tracking relative to the 262 events required to trigger the top line analysis? Is there any chance the readout could get bumped into third quarter? And then wondering if you can clarify what will be included in the top line and whether CR durability could be included in that update, or is that more likely to be reserved for a later medical conference?

Yeah, thanks so much for the question. So we are confident in the Q2 timing of the top line readout, so we expect to be able to hit the events in time, and we will be able to share top line data in Q2. We're very confident in that. In terms of what we expect to share, we're going to share the primary endpoint, which is PFS, for the trial. That's what the study's powered to show. In addition, we're going to share all the secondary endpoints that are mature as of the time of the top line data. as well as key safety tables. So we want to make sure that we're as transparent as possible with the market without compromising obviously publication that we expect to happen by the end of the year.

Got it. That's helpful. Thanks for taking my questions. Yeah, thank you. I appreciate it.

Thank you. And your next question comes from Michael Smith from Guggenheim. Please go ahead.

Hey guys, good morning. Thanks for taking my questions. Another one on Lotus 5 and sort of just thinking about your market projections and second line DLBCL. I think you spoke about an incremental $200 to $300 million opportunity, assuming maintaining sort of a 10% share. in that setting, and I was just wondering if that is perhaps too conservative. I'm just curious how you think about the market, especially now that we've seen Monjuvi perhaps moving into first line. We see some of the bispecific antibody data reading out, you know, perhaps below expectations, and so I'm just curious if there's upside perhaps to your Lotus 5 opportunity assessment, and then I had a follow-up question.

Yeah, I mean, I think based on the profile we saw in the safety run and if the final results look similar, we're obviously very highly confident that we can play a meaningful role in second-line plus TLVCL with this combination. To your point, we've already achieved an approximately 10% share in the third-line plus setting as a monotherapy. And I would say, you know, it has some attributes that physicians really like, the fact that it works very quickly, very durable CRRs, manageable safety profile, convenient dosing, One of the drawbacks right now is we have a less than competitive CR rate because we're competing against combinations. So, of course, now with the combination, we expect to have competitive and potentially even differentiating CR rates with a positive phase three study. So, we do feel confident we should be able to maintain that share in the 10% range in the third line plus setting. If we're able to maintain that same 10% in second line, that would translate to $300 million. The exact, I would say... Peak sales opportunity, we're going to know when we know the clinical profile because we think we can achieve this even with a competitive profile relative to other competitors. If we have a more differentiated profile, you know, potentially we could do more. But we'll revisit the peak sales opportunity once we know the final clinical profile of the combination.

Yeah, that makes sense. And then just another question, Lotus 5. So I'm just curious whether you've allowed crossover in this study. especially as it pertains to, you know, getting an early look at overall survival, you know, whether that's something that could perhaps be achieved. And then the other question, you know, related to that I had is, you know, how are you thinking about potential use of bioseasic antibodies post-progression, perhaps impacting OS? Obviously, that could happen in either arms of the study, but I'm just curious, you know, in general, perhaps, You know, how meaningful or how important you think OS could be as a differentiator in this setting, which obviously was not achieved by some of the other programs in second line?

Yeah, so we obviously don't know whether and how the subsequent therapies are between the different arms. So that's, you know, whether there were CAR-T bispecifics, as you said, or any other therapies, we're not obviously certain because we're completely blinded. in terms of the study, obviously, you know, subsequent therapies can affect overall survival. I think the way we look at this is, you know, we have a positive, you know, if we have a positive PFS without any detrimental effect to overall survival and overall a positive benefit risk profile, we think that we'll have a very good submission for the FDA.

Thank you. And your next question comes from Eric Schmidt from Cantor.

Please go ahead.

Hi, team. This is Alexa on for Eric, and congrats on a great year. So one question for me. So R&D spend was down about $10 million from the previous quarter. So do you expect what we're seeing in Q4 to be the current run rate going forward? All right. Thanks, guys.

Thanks, Alexa. Appreciate the question. So, Pepe, I'll turn that question to you around R&D spending Q4 and what we expect going forward.

Yes, thanks for the question. So, we expect that as we move to 2026 and 2027, R&D expenses should go down, assuming we maintain the current number of trials and the current pipeline that we have. As the lot of 5, Kyle, will continue to wind down, and then lot of 7 will get to a peak, but then will go down. So, RMB expenses are expected to fluctuate quarter over quarter, but in general for 26 and 27 to be going down.

Thank you so much.

Thank you. And your next question comes from Sudan Locanson from Stevens. Please go ahead.

Hi, good morning. Thanks for taking my question. The first one, you know, given the amended health care royalty agreement, they expect to cash from way into 2028. You know, how should we think about the capital allocation priorities between commercial investment behind the NANTA or advancing combination strategies and then the potential business development angle, especially considering the remaining deferred royalty and term loan obligations?

Yeah, I'll start off and then Pepe feel free to add.

So, you know, I would say that right now we feel pretty confident with our cash runway guidance that even with relatively stable revenues until we get to the new indications, which we expect to happen in 2027 with Lotus 5, and as well as with the cost guidance that Pepe just mentioned, for all the activities that we have currently planned, our current Lotus 5, our current Lotus 7, our current IITs, all of our current ongoing activity, as well as investing more pre-launch in both commercial and medical affairs activities. Those are all the assumptions that we have in our current guidance. Obviously, if we were to do any additional lifecycle management or new activities, that would not be currently based within our cash runway guidance that we have right now. We think the ACR agreement provides strategic flexibility now, because obviously by reducing the... reducing the change in control payment just allows more strategic flexibility and optionality for the company going forward. And so we were really pleased by that. In exchange, of course, they continued the royalties, which given that our COGS is low to mid single digit, when you add in the royalty agreement, the gross margin is still quite good for this property when you add both of those things in. But Pepe, is there anything else you would add to what I just said?

Yeah, I think you gave all the details. At the end of the day, we were solely focused on driving CELANTA growth, and that's by completing the LOTUS 5, LOTUS 7, and indoor uniformity trials. That capital has been allocated and is part of our cash runway, as well as all the pre-launch activities and launch activities of CELANTA in 2027 in the second line setting. It does also cover some of those expenses related to a loan. So it's all included. We believe we have a really strong cash position right now to execute on our plan.

Thanks. And if I could, just a second one real quick, I wanted to ask about if you can give any details on maybe your market strategy, you know, as you get some of these last final data readouts this year and, you know, looking, going towards the regulatory, you know, pathway first happened next year. Could you give us any details on how your marketing strategy could change to get into the DLBCL space, the second line space? Thanks.

I mean, the good thing is we have a very good footprint. So our field force already covers about 90% of the potential of DLBCL. We have a full MSL team as well and a strong headquarter team. So we will make some incremental increases both in the commercial and MSL footprint, as well as some additional expenses in terms of A&P and other expenses on a headquarters basis. But I would say incremental because we think we're already pretty well covered. Obviously, when you do the pre-launch and launch activities, and we can expand into a much bigger population, the second-line population, which we think also with a better profile than we have today, those incremental investments are going to help us. to make sure that we drive an education around the product use, particularly when we anticipate a Lotus 5 approval sometime in the middle of next year. We think Lotus 5 obviously is also key because once we get to the top line readout next year, it really actually unlocks the total value of the lifecycle management plan for Zinlanta because that is our full approval. And we think that the total opportunity that we have for Zinlanta, not just with Lotus 5, but you know, assuming we can have regulatory approvals and compendia for the other indications, it can take the total peak revenue opportunity for Zalanta to $600 million to $1 billion. So we think that Zalanta, but as far as we know, Q2 is really a key unlocking event to start driving the value of the total asset potential.

Great. Thanks.

Thank you.

And your last question comes from Leonid Timyshev from RBC Capital Markets. Please go ahead.

Hey, guys. Thanks for taking my question. I just wanted to ask on sort of the current commercial run rate for Zinlanta. I guess you've had a couple of stronger quarters. I guess at what point do you think that becomes a trend where you're actually seeing genuinely more enthusiasm and use from investigators in the current label indication, or is this still seasonality? And maybe what does that tell you about, you know, potential future launch of Zinlanta as you expand the indication? Thanks.

Yeah, I mean, I think we're pleased that, you know, over the last couple of years, since buy specifics have launched, we've basically been able to maintain our share within a space that's gotten a lot more competitive. So I think we feel really good about that. If you look, you know, more broadly at 2025 versus 2024, volumes are roughly stable. You know, there's some slight increase in sales, mainly driven to slight increases in net price. So, you know, we don't provide any annual net price. revenue guys, but we expect this year sales again to remain broadly in line with what we've seen in the recent years. And the real inflection point will start when we get the approval for Lotus 5 next year, where we think we can really significantly increase the potential sales opportunity for Zonlanta.

Thank you. There are no further questions at this time. You may proceed with the conference.

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. Operator, you may now end the call.

Ladies and gentlemen, this does conclude your conference call for today. We thank you very much for your participation. You may now disconnect. Have a great day.