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spk07: Welcome to the ADC Therapeutics Second Quarter 2024 Financial Results Conference Call. My name is Deedee, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press star, then 1-1 on your touchtone phone. I will now turn the call over to Marcy Graham. Investor Relations Officer for ADCT. Marcy, you may begin.
spk08: Thank you, operator. This morning, we should announce in our second quarter 2024 financial results and business update. 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, and our CFO, Pepe Carmona, who will discuss recent business highlights and review our second quarter 2024 financial results. We'll 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 state harbor provisions of the US 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 presentation on slide three and in the company's filings of 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 in substitute for the information prepared in accordance with GAAP. You should refer to the company's second quarter earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures. I'll now turn the call over to our CEO, Anit Malik. Anit.
spk04: Thanks, Marcy, and thank you all for joining us. Today, I'd like to start by reminding everyone about our strategy to unlock the tremendous value we see in the company. Our first pillar and primary focus is hematology. Within this, we have a de-risked asset in Zanlanta, the key product in our prioritized portfolio. We continue to lay the foundation through our commercialization efforts in our existing third-line plus DLBCL indication while we pursue the substantially larger potential opportunities in earlier lines of DLBCL therapy and indolent lymphomas. The second pillar of our strategy is grounded in our emerging solid tumor pipeline. ADCT601 targeting Axil is our most advanced asset. Beyond this, we are advancing a broad portfolio of differentiated ADCs against solid tumor targets of interest driven by our novel exotique and base platform. In the second quarter of 2024, we continued our focus on execution, advancing programs on several fronts in our Zanlanta expansion plan while working to deliver on our commercial strategy. In the first half of 2024, we achieved commercial profitability with revenues of $34.9 million year to date. Our second quarter revenues of $17 million compared to revenues of $17.8 million in the first quarter of 2024 and $19.2 million during the same period in 2023. Even in a highly competitive market, we've been able to secure our place as a treatment option for third-line plus patients with DLBCL. We've observed quarter to quarter variability over time and we've seen continued competition in the third-line plus space with Bi-Specifics. That said, the commercial business is now self-funding and it's expected to be so going forward. We are confident in the roles in Zanlanta placed today in the third-line plus DLBCL setting given its clinical profile as a monotherapy with rapid and durable complete responses, manageable safety and ease of administration. Within our current indication, we see the potential to further strengthen our presence in the market even as the environment grows increasingly competitive. We are excited about the potential that grows in Zanlanta beyond our current indication into earlier lines of DLBCL and into lymphomas, significantly expanding the commercial opportunity. We are progressing in our second-line plus expansion efforts. Last week, Lotus 5, our phase three confirmatory study of Zanlanta in combination with BrutuxMap, passed futility and enrollment is nearing completion with full enrollment expected by the end of 2024 and with data likely by the end of 2025. In our Lotus 7 trial, enrollment remains on track in the part two dose expansion of the Zanlanta plus Clofidimab combination arm in second-line plus DLBCL and complete enrollment is expected by year end. An update on safety and efficacy in a valuable patient is expected by the end of 2024 with data on all patients anticipated in the first half of 2025. We are also progressing our solid tumor programs. ADCT601, our novel axle targeting ADC, continues to enroll sarcoma and pancreatic cancer patients as we optimize the dose and scheduling and have begun screening non-small cell lung cancer patients. We plan to share an initial update from the phase one trial in the second half of 2024. And since sharing a comprehensive update in April on our novel FCT can base solid tumor platform, including early data on our four lead preclinical ADC candidates, we have selected one candidate to move forward, which we expect to disclose in 2025 and continue to explore potential partnership opportunities. Throughout the quarter, we maintained our disciplined capital allocation strategy and decreased operating expenses in the second quarter by 23% year over year on a non-GAAP basis. This, in addition to our recent financing of $105 million, enabled us to extend our expected cash runway into mid-2026, providing the company with a stronger balance sheet to execute against our strategy. As we have now reached commercial profitability for Zinlanta in 2024, I'd like to go deeper on the substantially larger potential opportunity for Zinlanta in earlier lines of DOBCL therapy and indolent lymphomas. Our LOTUS V and LOTUS VII trials are focused on expanding usage of Zinlanta into second line plus DOBCL. Assuming positive results based on these two studies, we are confident in our strategy to become the combination agent of choice in this setting with the potential to reach more than $500 million in peak sales. Our LOTUS V trial continues to advance and we are pleased to announce a positive outcome on the interim utility analysis. The independent data monitoring committee has reviewed the unblinded efficacy and safety data and recommended to continue the trial without modification. As we have now passed utility, we remain on track to complete enrollment by the end of this year, with the potential for a headline readout by the end of 2025. If positive, we believe this trial will lead to full approval for Zinlanta, potentially as early as the end of 2026 and expand our indication into second line plus DOBCL in combination with what we are talking about, a treatment frequently used in the community setting. This could triple the potential revenue opportunity by doubling the potential patient population and increasing the treatment duration by roughly 50% compared to the current Zinlanta label. In our LOTUS VII trial combining Zinlanta with BiSpecifx, we continue to be encouraged by the initial safety and tolerability profile, as well as the anti-tumor activity observed at the initial investigator assessment among the majority of patients in part one of the dose escalation. Enrollment is ongoing in part two dose expansion with Zinlanta plus Clofidimab in second line plus DOBCL, and we expect to complete enrollment and plan to share additional efficacy and safety data before year end. We are excited by the opportunity to demonstrate that this Zinlanta combination can improve efficacy versus either agent and reduce the potential need for hospitalization associated with BiSpecifx, thereby expanding accessibility in the community setting. Beyond DOBCL, we also see the potential to expand into the second line setting of indolent lymphomas based on initial data from investigator initiated trials at the University of Miami exploring Zinlanta model therapy in marginal zone lymphoma and Zinlanta plus Rituximab in follicular lymphoma. Early data from these studies demonstrate the potential for rapid, deep and durable efficacy with a fixed duration of therapy and a manageable side effect profile. Based on the high CRH seen thus far in these studies, we believe there's the potential to provide marginal zone and follicular lymphoma patients years of remission. As there remain significant unmet need across these indolent lymphomas, with sufficient data we plan to discuss the path forward with regulatory authorities as well as seek inclusion in compendia. We anticipate more will be shared on these two trials at future medical meetings. Within solid tumors, we continue to investigate ADTT601 targeting Axel in a phase one study. While others have explored Axel as a therapeutic target, we have a potentially differentiated profile with 601 due to its innovative design, incorporating a PBD toxin, as well as our patient selection approach with our validated biomarker assay. Axel is expressed in multiple tumor types and it has been shown that the high expression of Axel is correlated to lower overall survival across many cancer types, including sarcoma, pancreatic cancer and non-small cell lung cancer. In this trial, we continue to enroll sarcoma and pancreatic cancer patients as we optimize the dose and schedule and have begun screening in non-small cell lung cancer patients. With respect to our preclinical pipeline, our focus is on advancing differentiated ADC candidates against prostate, non-small cell lung, colorectal, endometrial and ovarian cancers. For each tumor type, the combination of incidence and five-year survival offers large potential opportunities and indicates that better treatment options are needed. Furthermore, in each case, chemotherapy remains a key part of the treatment armamentarium. From our four lead ADC candidates, NAVITB, CLAWDN6, PSMA and ASCT2, we have now selected one to move forward to IND, which we expect to disclose in 2025. In terms of stage, our NAVITB, CLAWDN6 and PSMA ADCs are in IND enabling studies and our ASCT2 ADC is in the drug candidate selection stage, which we expect to complete this year. And we continue to seek research collaborations to advance a broad portfolio as we believe each offers the potential to improve the standard of care for cancer patients and each utilizes our novel exotekin-based platform. Preclinical work suggests that our four lead candidates each have a high therapeutic index reflecting the proprietary design of the ADC. Given the unmet medical need coupled with the market opportunity, a successful outcome for our early research programs has the potential to transform the lives of patients and create significant value in the future. With that, I would like to turn the call over to Pepe.
spk01: Thank you, Amit. I will now take you through a brief summary of our second quarter results. Starting with our balance sheet, as of June 30th, we had cash cash equivalents of approximately $300 million. Moving to the P&L, as you already heard, the Londonet product revenues were $17 million for the second quarter and $34.9 million for the first six months of 2024, as compared to $19.2 million and $38.2 million for the same period in 2023. The quarter over quarter decrease is primarily due to lower sales volume partially offset by a higher price. The year today decreases primarily due to lower sales volumes, as well as higher gross to net deductions primarily due to the discarded drug rebate accrual partially offset by a higher price. Our total operating expenses on a non-GAAP basis, which excludes stock-based compensation, were down 23% compared to the second quarter of last year. This mainly reflected our focus on driving operating efficiencies, together with reduced R&D expenditures due to focused investment on our clinical studies and efficiencies in selling and marketing expenses. For the remainder of 2024, we will continue to take a very disciplined approach to our capital allocation. You can find the reconciliation of GAAP measures to non-GAAP measures in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation. Moving to the bottom of the P&L, on a GAAP basis, we reported the net loss of $36.5 million for the quarter. Or $0.38 per basic and diluted share. On a non-GAAP basis, adjusted net loss was $24.4 million, or an adjusted net loss of $0.25 per basic and diluted share. The decrease in both reported and adjusted net loss compared with the second quarter of 2023 was primarily due to lower operating expenses. With our strong balance sheet, we believe we are well-financed to continue to pursue our corporate strategy. As a reminder, hematology continues to be the primary focus of our capital allocation. And within this, our key objective is to create value by expanding the use of SINLONTA beyond our current indication. We expect to achieve this by fully supporting our commercialization efforts in the US directly and through our partnership XUS and by investing behind potential expansion into early lives of TLPCL and indolently formats. In solid tumors, our aim is to pursue multiple ADC candidates in parallel and increase our shots on goal, mainly through our novel XTATICAM-based research platform. In addition to the candidate we are taking forward to IND, we will determine on a -by-case basis whether we wish to progress additional candidates internally or seek to partner in order to share the development and financial risk. Finally, I would like to highlight that we have multiple potential value-driving milestones which we expect in the second half of this year. This catalyst include expected completion of enrollment in LOTUS V, initial efficacy and safety data from LOTUS VII Part II expansion, and an initial read of ADCD 601 in Axel in both sarcoma and pancreatic cancer. In the first half of 2025, we expect mature data for our LOTUS VII and Axel trials and anticipate indolently format data will be shared at medical meetings in 2024 or 2025. With that, I will turn the call back to Amit.
spk04: Thanks, Pepe. As we've illustrated today, we made significant progress in the second quarter and are excited about what's ahead in the second half of 2024. We have achieved commercial profitability with Zanonta by driving operating efficiencies while maintaining our customer-facing coverage and medical support. We continue to be on track for each of our plan key research and development milestones, and we maintained our disciplined approach to capital allocation. Looking ahead with a strong balance sheet to execute our strategy, I am confident that ADC Therapeutics is well positioned to drive value creation for all our stakeholders. With that, operator, could you please begin the Q&A session?
spk07: Thank you. We will now begin the question and answer session. If you have a question, please press star, then one, one on your touchtone phone. If you wish to be removed from the queue, please press star, one, one again. If you are using a speakerphone, you may need to pick up the handset first before pressing the numbers. Once again, if you have a question, please press star, then one, one on your touchtone phone. One moment.
spk06: Eric Schmidt from Cantor Fitzgerald is online
spk07: with a question.
spk05: Thank you for taking my question and congrats on the progress. Maybe first for Amit on the Lotus V interim look, was there any other statistical consideration given other than a potential futility analysis? Could there have been say a trial beside same or any other outcome other than halting the study?
spk04: Yeah, thanks Eric. That was a great question. So the Independent Data Monitoring Committee reviewed the unblinded efficacy and safety data and recommended to continue the trial without any modifications. So in terms of what they looked at, this was an interim analysis for futility with pre-specified efficacy boundaries based on PFS, which as you know is the primary efficacy endpoint. And that passed per IDMC review. The IDMC obviously also was looking at unblinded safety data and directly noted that the treatment emergent AEs were as expected in this very, as you can imagine, vulnerable and pre-treated population. So their recommendation was to continue the study without any modifications. And certainly for us, just increases our confidence around the study. And you haven't disclosed
spk05: what those PFS boundaries are, I assume?
spk04: Yeah,
spk05: we
spk04: haven't
spk05: disclosed. Okay, and then in terms of some of the upcoming milestones for the second half of the year, you've got several lined up. Can you be a little bit more specific about what form they might take place, which might be at medical meetings, which might be in corporate events or press releases?
spk04: Yeah, so most of them will be at the end of the year. Well, it'll be a combination, but I would say specifically if you look at Modus 7, which is probably one of the big ones, this would be likely through a corporate disclosure, simply because as we've disclosed in the past, we wanna enroll 40 patients in our trial by the end of the year. The data we're gonna have available, we'll make available for any patients that have cleaned at least 12-week scans so that any responses have been confirmed. So basically, once you get to late August, you kind of get to the cutoff of what's gonna be shown. We wanna make sure that we can show as much data as possible. We expect to have the full data from that trial in the first half of next year. Similarly with Axel, where we're currently doing, dosing a number of patients in pancreatic cancer, as well as in sarcomas, and have just begun screening patients in non-physiologic cancer. We wanna make sure that we can share the data that we have. And so as you can imagine, cutoffs for congresses like Ash and others have already happened actually in August. So that'll be, again, a company disclosure. So those are probably two of the biggest disclosures. What I would say is in terms of indolent lymphomas, whether it's this year or next year, the next set of updates will be at medical meetings. Great, thank you very much. Yeah, thank you.
spk06: Thank you. Kelly Shi from Jeffries is online with a question.
spk09: Thank you for checking my questions and congrats on the progress. Maybe in terms of the variability in order and pattern following along to your comment in past release, could you provide more color on this front? Is this a variability in terms of the academic and community split in prescription? And also maybe comments on distribution inventory channel and also goes to NET. Thank you.
spk04: Okay, so I'll comment on the order, the variability that we see by quarter and then I'll turn to Pepe to talk about gross to net in the quarter and how that's evolved. So if you look at quarter by quarter variability, a lot I would say is just month by month. So I'll just give you some examples. We may have a large academic institution, I'll give you a real example, that ordered for example in January, but they order significant amount of quantity because as you can imagine, we're a relatively rare disease and the number of cycles on average is about four. So you don't need a lot of vials per patient. So they may order for five, 10 patients and for the next five to 10 patients and then not need to order for three or four months. And so that happens a lot also at some smaller accounts where you just see order pattern. So we see certain months which are much higher and certain months which are much lower and depending on how the quarters get cut off, that can affect performance. And we've seen this in the past too since the launch where you see some up and down fluctuation. What I would say is that, despite increasingly competitive environment, we're still seeing a strong place for Zinlanta in the academic settings. We're seeing a lot of use either where bi-specific can't be used or post bi-specifics. And I think really, it's just in the academic setting, there's a clear understanding of how and when to use. Zinlanta you see much more stability in that setting. In the community, there's variability because you've seen some adoption of bi-specifics in very large community accounts, but of course the majority of accounts have not yet adopted bi-specifics. And the variability comes with just, when they see patients or not see patients. An average community physician may only see a patient every couple of months. So in any quarter, if you look at accounts, depending on what patients that show up and if they're suitable for Zinlanta, you can get more or less. That's why we do see typically month to month and even quarter to quarter variability.
spk01: Thank
spk08: you, very helpful.
spk01: On the gross net side, Kelly, we saw a favorable prior period adjustment this quarter. I would expect that to be just a one-off. In general, if you look at the year today, the Q1, that's what you should expect as we go for the balance of the year.
spk09: Thank you very much. And also I have follow up regarding the Solid Tumor Program 601, targeting EXO. So what is the relative proportion of a sarcoma versus pancreatic cancer patients will be enrolled and to be shown like data by the end of the year and also like any particular sub-tabs you're gonna focus on sarcoma enrollment. Thank you.
spk04: Yeah, so for sarcoma, we're focused on soft tissue sarcoma. And in terms of enrollment, actually both are enrolling at a pretty good pace, to be honest. I mean, as you know, there's very high access expression so we don't even need to select patients for sarcoma. So although it's rare, that not needing to select obviously and helps to drive up the numbers. And given the early signals that we saw, there's a lot of awareness within the community when you get to that late line setting, there's not a lot of options for these patients. So we see continued good enrollment and similarly with pancreatic. Again, these tend to be very late line patients, right? That have already failed multiple prior therapies. And the prognosis for these patients isn't great. So there we're doing an enriched strategy. We're looking at different levels of expression to understand where the cutoffs can be. And again, we'll have a number of patients now, I can't tell you exactly what the proportion will be of those who have expression of axle versus those that don't. That's the work that's ongoing, but I think we'll have a meaningful number in both of those tumors. In non-small cell lung cancer, given that we've just started screening and the proportion of axle expression is lower, I don't expect to be able to share an update on non-small cell lung cancer. As we've said previously, we expect that to come more in the first half of next year.
spk09: Terrific, thank you very much.
spk04: Yeah, thank you.
spk06: Thank you. Michael Schmidt from Guggenheim is online with a question.
spk00: Yeah,
spk03: hey, good morning. Thanks for taking my questions. So Roche recently reported positive data from their STARGLOW study evaluating their T25 specific antibody and second line DLBCL. How do you expect that to affect market dynamics in that setting and perhaps the opportunity for Zalanta obviously evaluating both Lotus V and Lotus VII studies in that same setting?
spk04: Yeah, look, I think the STARGLOW data was impressive from an efficacy standpoint. I think it validated that combinations of toxins with bi-specifics is a really good approach. So maybe just to talk about the implications of what STARGLOW is gonna mean for both Lotus V and for Lotus VII. On the Lotus V front, I think as you're aware, the primary endpoint is needed PFS. And in our trial, we're doing Zalanta plus for toxin valve versus R-GemOx. And there hasn't been a lot of modern data, especially large scale clinical data with R-GemOx in recent years, especially in the current treatment landscape. So seeing the data where, and if you look at the STARGLOW data, the R-GemOx arm had roughly 3.6 months of PFS. I think that provides us a clear opportunity to do better. I mean, so it gave us even more confidence, I would say, in Lotus V because the study's powered with even a two month difference to be a positive study. Obviously, we would hope to do much better than that because we wanna make sure it's clinically relevant as well. But to us, that kind of clearly showed that we believe Zalanta can be better than the GemOx. Retoxin valve is obviously constant across both arms in Lotus V, but we believe Zalanta has the opportunity to prove to be better than GemOx. But also to do this where we don't have, we've not seen any new safety signals as we reported before, but there's also no CRS, no ICANS, and this makes it a very accessible option in the community, either in the second line setting or even in the academic setting for those who progress in the third line plus setting. So I think it's gonna be a great combination. There's still a lot of R-based chemo use that exists within the community. And so Zalanta Plus, we talked about, has the opportunity to provide better efficacy with a better tolerability profile than what exists today. Now, if you look at Lotus VII, StarGlo obviously showed over 13 months of PFS with GloFit plus GemOx. So the efficacy bar and with about a 58% CR rate, so the efficacy bar I think is high. I think it's pretty clear that we're gonna need to be comparable or better from an efficacy standpoint. That's what matters most when you talk about more potent therapies like biophysicist recombinations. And so I think it clearly set a bar around that. But we believe that Zalanta and GloFit, as we've seen in early data and we hope to show with the expansion data, can have a synergistic or even additive effect. And when you look at the fact that Zalanta Plus Retuximab in our early safety running data showed already 50% CR rates, we're hopeful obviously we believe GloFit is significantly more potent than Retuximab and combining GloFit plus Zalanta has the opportunity to do even better. I mean, we're hopeful that we can approach the 60% range. And I think if you get to that level of efficacy, that's very, very meaningful. But in addition to that, we're hoping that we can continue to show what we saw on the dose escalation, which is reduced rates and grades of CRS, which can hopefully enable a broader accessibility in the community, especially to a non-systemic chemo-free combination for patients. And I think that's the opportunity we have in our dosing regimen. When you look at not only some of the toxicities with the Bi-Specific, which we hope to reduce in the way we're dosing Zalanta, but also GemOx, where you see cumulative irreversible adverse events, including neurotoxicity and neuropathy. I think there's an opportunity to improve on both the efficacy and safety profile for the second.
spk03: Great, thanks Malik. And then just regarding the marginal cell lymphoma and the follicular lymphoma interim data that you had presented, obviously looks super impressive. Just wondering if there may be an opportunity to include that into guidelines prior to publishing the full results sometime next year. Is that a possibility, or would you need to wait for completion of those two studies? Thank you so much.
spk04: Yeah, I think it's possible before the presentation, but I think what it's gonna require is a presentation at a major medical congress and a concomitant publication. I think whenever you wanna submit the guidelines, you do need a publication in a key medical journal. And of course, it's gonna be data-driven, and driven also by the investigators of the study. But we've seen, for example, in marginal zone, the last BtK inhibitor, which is added to the guidelines in a preferred position, had 36 patients. So it is possible that the data looks good and the data gets published before the full completion, in that case, of the study of 50 patients. But I can't commit yet. I think it's gonna be very data-driven, and driven by not only the efficacy that we see, but the durability of that efficacy. And then when there's a sufficient number of patients it can get published in a major journal. But obviously, given the unmet need in these areas, we're working closely with the investigators to make sure that once there is a meaningful amount of data, it can be published. And of course, then we would plan to talk to both regulators and go to seek compendia inclusion. Yeah,
spk03: makes
spk04: sense. Thank you.
spk06: Thank you. Brian Cheng from JP Morgan is in line with
spk07: the question.
spk02: Hey guys, thanks for taking our questions this morning. Maybe just going back to salon for sales, it seems that some of the variability can be explained by inventory build at some of the institutions. Can you comment on the growth in your, whether there is any growth in your prescriber base in academics versus community? What are you seeing? What are you seeing currently in the market and how confident are you that you will be able to see continued growth for the rest of the year? Thanks.
spk06: Please stand by, your conference will begin momentarily. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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