Q2 2024 ADC Therapeutics SA Earnings Call
Dede: Welcome to the ADC Therapeutics Second Quarter 2024 Financial Results Conference Call. My name is Dede and I will be your operator for today's call.
Dede: Call. My name is Dede, 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
Unknown Questioner: Hey guys, thanks for taking our questions this morning.
Dede: At this time, all participants are in a listen-only mode.
Marcy Graham: Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star, then 11 on your touchtone phone. I will now turn the call over to Marcy Graham, Investor Relations Officer for ADCT.
Marcy Graham: Thank you, operator. This morning, we should release our second quarter 2024 financial results and business update. This release and the slides we will use in today's presentation are available in the investor section of the ADC Therapeutics website. I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, 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.
Speaker Change: Marcy, you may begin.
Marcy Graham: Thank you, Operator. This morning, we should request release announcing our second quarter 2024 financial results and business updates.
Speaker Change: This release and the slides we will use in today's presentation are available on the investor section of the ADC Therapeutics website.
Speaker Change: I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, 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.
Marcy Graham: 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.
Speaker Change: 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.
Unknown Executive: 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 3 and in the company's filings with the SEC, including Form 10-K, 10-Q, and 8-K. ABC 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.
Speaker Change: These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance, and achievements could differ materially.
Speaker Change: They are identified and described in the accompanying presentation on slide three and in the company's filings with the SEC, including Form 10-K , 10-Q, and 8-K.
ABC Therapeutics: 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.
Unknown Executive: 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.
ABC Therapeutics: The company cautions investors not to place undue reliance on these forward-looking statements.
ABC Therapeutics: 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.
ABC Therapeutics: 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.
ABC Therapeutics: I will now turn the call over to our CEO , Ameet Mallik. Ameet?
Ameet Mallik: 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.
Ameet Mallik: Our first pillar and primary focus is hematology. Within this, we have a de-risked asset in Zenlanta, the key product in our prioritized portfolio.
Ameet Mallik: 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.
Ameet Mallik: The second pillar of our strategy is grounded in our emerging solid tumor pipeline. ADCT601 targeting Axel is our most advanced asset.
Ameet Mallik: Beyond this, we are advancing a broad portfolio of differentiated ADCs against solid tumor targets of interest driven by our novel Exotequin-based platform.
Ameet Mallik: In the second quarter of 2024, we continued our focus on execution, advancing programs on several fronts in our Zenmanta Expansion Plan while working to deliver on our commercial strategy.
Ameet Mallik: In the first half of 2024, we achieved commercial profitability with revenues of $34.9 million year-to-date.
Ameet Mallik: 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.
Ameet Mallik: Even in a highly competitive market, we've been able to secure our place as a treatment option for third-line patients with DLV-CL.
Ameet Mallik: That said, the commercial business is now self-funding, and it's expected to be so going forward.
Ameet Mallik: We are excited about the potential that grows in Monta beyond our current indication into earlier lines of DLVCL and in lymphomas, significantly expanding the commercial opportunity.
Ameet Mallik: We are progressing in our Second Life Plus expansion efforts.
Ameet Mallik: In our LOTUS 7 trial, enrollment remains on track in the Part 2 dose expansion of the Zunlata plus Clofidimab combination arm in Second Line plus DLBCL, and complete enrollment is expected by year end.
Ameet Mallik: We are also progressing our solid tumor programs. ADCT601, our novel axial 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.
Ameet Mallik: We plan to share an initial update from the Phase 1 trial in the second half of 2024.
Ameet Mallik: And since sharing a comprehensive update in April on our novel exoteque and base solid tumor platform, including early data on our four lead preclinical ADC candidates,
Ameet Mallik: We have selected one candidate to move forward, which we expect to disclose in 2025 and continue to explore potential partnership opportunities.
Ameet Mallik: As we have now reached commercial profitability for Zynlanta in 2024, I'd like to go deeper on the substantially larger potential opportunity for Zynlanta in earlier lines of DLBCL therapy and indolent lymphomas.
Ameet Mallik: 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. With that, I would like to turn the call over to Pepe.
Ameet Mallik: 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 dollars in peak sales.
Ameet Mallik: Our LOTUS 5 trial continues to advance and we are pleased to announce a positive outcome on the Interim Futility Analysis.
Ameet Mallik: If positive, we believe this trial will lead to full approval for Zanlanta, potentially as early as the end of 2026, and expand our indication into Second Line Plus DLBCL in combination with Rituximab, a treatment frequently used in the community setting.
Ameet Mallik: 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 ZMATA label.
Ameet Mallik: In our LOTUS-7 trial, combining Xenlanta with five specifics, 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 1 of the dose escalation.
Ameet Mallik: Enrollment is ongoing in Part 2, Dose Expansion with Zymlanta plus glifidimab in Second Line plus DLVCL, and we expect to complete enrollment and plan to share additional efficacy and safety data before year-end.
Speaker Change: We are excited by the opportunity to demonstrate that this in-laws accommodation can improve efficacy versus either agent and reduce the potential need for hospitalization associated with bi-specifics, thereby expanding accessibility in a community setting.
Ameet Mallik: Beyond DLBCL, we also see the potential to expand into the second-line settings.
Ameet Mallik: of Indolent Lymphomas, based on initial data from investigator-initiated trials.
Ameet Mallik: at the University of Miami exploring Zanlanta monotherapy in marginal zone lymphoma and Zanlanta plus rituximab in follicular lymphoma.
Ameet Mallik: 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.
Speaker Change: Based on the high CRH seen thus far in these studies, we believe there is the potential to provide marginal zone and follicular lymphoma patients years of remission.
Ameet Mallik: As there remains 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.
Ameet Mallik: We anticipate more will be shared on these two trials at future medical meetings.
Ameet Mallik: Within solid tumors, we continue to investigate ADCT601 targeting AXL in a phase 1 study.
Ameet Mallik: AXL is expressed in multiple tumor types and it has been shown that the high expression of AXL is correlated to lower overall survival across many cancer types including sarcoma, pancreatic cancer, and non-small cell lung cancer.
Ameet Mallik: 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.
Ameet Mallik: From our four lead ADC candidates, Navi2B, ClaudeN6, PSMA, and ASCT2, we have now selected one to move forward to IND, which we expect to disclose in 2025.
Ameet Mallik: Preclinical work suggests that our four lead candidates each have a high therapeutic index reflecting the proprietary design of the ADC.
Ameet Mallik: 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.
Pepe Carmona: Thank you, Ameet. I will now take you through a brief summary of our second quarter results. Moving to the P&L, as you already heard, long-term net 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 2021.
Ameet Mallik: With that, I would like to turn the call over to Pepe.
Pepe Carmona: Thank you, Ameet. I will now take you through a brief summary of our second quarter results.
Pepe Carmona: Starting with our balance sheet, as of June 30th, we had cash-to-cash equivalents of approximately $300 million.
Speaker Change: The Lontanet 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.
Pepe Carmona: 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.
Pepe Carmona: For the remainder of 2024, we will continue to take a very disciplined approach to our capital allocation.
Pepe Carmona: 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.
Pepe Carmona: was $0.38 per basic and diluted share. On a non-gap basis, adjusted net loss was $24.4 million or an adjusted net loss of $0.25 per basic and diluted share.
Pepe Carmona: The decrease in both reported and adjusted net loss compared with the second quarter of 2023 was primarily due to lower operating expenses.
Pepe Carmona: With our strong balance sheet, we believe we are well financed to continue to pursue our corporate strategy.
Speaker Change: 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.
Pepe Carmona: We expect to achieve this by fully supporting our commercialization efforts in the U.S. directly and through our partnership Ex-U.S., and by investing behind potential expansion into early lives of TLBCL and indolent informants.
Speaker Change: In Solid Tumors, our aim is to pursue multiple ADC candidates in parallel and increase our shots on goal, mainly through our novel extratica-based research platform.
Speaker Change: In addition to the candidate we are taking forward to IND, we will determine on a case-by-case basis whether we wish to progress additional candidates internally or seek to partner in order to share the development and financial risks.
Speaker Change: Finally, I would like to highlight that we have multiple potential value-driving milestones which we expect in the second half of this year. These catalysts include expected completion of enrollment in LOTUS 5,
Speaker Change: Initial efficacy and safety data from blood of seven part two expansion and an initial read of ADCD 601 in Axel in both sarcoma and pancreatic cancer.
Speaker Change: In the first half of 2025, we expect mature data for our LOTUS-7 and AXEL trials and anticipate indominant lymphoma data will be shared at medical meetings in 2024 or 2025.
Speaker Change: With that, I will turn the call back to Ameet.
Ameet Mallik: 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.
Speaker Change: We have achieved commercial profitability within Manta by driving operating efficiencies while maintaining our customer-facing coverage and medical support. We continue to be on track for each of our planned key research and development milestones, and we maintained our disciplined approach to capital allocation.
Speaker Change: 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?
Speaker Change: Thank you. We will now begin the question and answer session.
Speaker Change: If you have a question, please press star then 1-1 on your touchtone phone.
Speaker Change: If you wish to be removed from the queue, please press star 11 again. If you are using a speakerphone, you may need to pick up the handset first before pressing the numbers.
Speaker Change: Once again, if you have a question, please press star then 1-1 on your touch-tone phone. One moment.
Speaker Change: Eric Schmidt from Cantor Fitzgerald is online with a question.
Speaker Change: Thank you for taking my question and congrats on the progress. Maybe first for Ameet on the Lotus 5 interim look, was there any other...
Speaker Change: Statistical consideration given other than a potential futility analysis? Could there have been, say, a trial resizing or any other outcome other than halting the study?
Speaker Change: 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.
Speaker Change: without any modifications.
Speaker Change: So in terms of what they looked at, this was an interim analysis for futility with pre-specified efficacy boundaries.
Speaker Change: boundaries based on PFS, which, as you know, is the primary efficacy endpoint, and that passed per IDMC review.
Speaker Change: The IDFC 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 pretreated population.
Speaker Change: Their recommendation was to continue the study without any modifications, and certainly, for us, just increases our confidence around the study.
Speaker Change: And you haven't disclosed what those PFS boundaries are, I assume.
Speaker Change: Yeah, we haven't disclosed.
Speaker Change: Okay, and then...
Speaker Change: 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 forum might take place, which might be at medical meetings, which might be corporate events or press releases?
Speaker Change: 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 Lotus 7, which is probably one of the big ones, this would be likely through a corporate disclosure, simply because
Speaker Change: As we've disclosed in the past, we want to enroll 40 patients in our trial by the end of the year.
Speaker Change: The data we're going to have available, we'll make available, are for any patients that have cleaned at least 12 weeks scans, so that any responses have been confirmed.
Speaker Change: So basically, once you get to late August , you kind of get to the cutoff of what's going to be shown. We want to 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.
Speaker Change: Similar with Axel, where we're currently doing, dosing a number of patients in pancreatic cancer as well as in sarcoma and have just begun screening patients in non-post-mortem cancer, we want to make sure that we can share the data that we have. And so as you can imagine, cut-offs for Congresses like Ash and others.
Speaker Change: happened already or already happened actually in August . So that'll be again a couple disclosures. So those are probably two of the biggest disclosures.
Speaker Change: What I would say is in terms of ambulant lymphomas, whether it's this year or next year, the next set of updates will be at medical meetings.
Speaker Change: Great, thank you very much.
Speaker Change: Yeah, thank you. Thank you.
Speaker Change: Kelly Shee from Jeffries is online with a question.
Kelly Shee: Thank you for taking my questions and congrats on the progress. Maybe in terms of the variability in order and pattern for the launch, you commented in past release, could you provide more color on this front?
Speaker Change: Is this a variability in terms of the academic and community split in prescription and also maybe common distributing inventory channels and also growth to net? Thank you.
Speaker Change: 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.
Pepe Carmona: So if you look at, you know, 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
Speaker Change: 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.
Speaker Change: So, you know, they may order for 5-10 patients, and for the next 5-10 patients, and then not need to order for 3 or 4 months.
Speaker Change: And so that happens a lot also at some smaller accounts where you just see order patterns. 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.
Speaker Change: What I would say is that, you know, despite an increasingly competitive environment, we're still seeing a strong place for Zananta in the academic settings. We're seeing a lot of use either where bispecifics can't be used or post-bispecifics.
Speaker Change: And I think really, especially in an academic setting, there's a clear understanding of how and when to use.
Speaker Change: 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.
Speaker Change: The variability comes with just, you know, 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 Zolanta, you can get more or less. That's why we do see typically month to month and even quarter to quarter variability.
Speaker Change: Thank you. Thank you.
Speaker Change: The Grosvenor side, Kelly, we saw a favorable product period adjustment this quarter. I would expect that to be just a one-off. In general, if you look at the year-to-date or even the Q1, that's what you should expect as we go for the balance of the year.
Speaker Change: Thank you very much. And also, I have a follow-up regarding the Solid Tumor Program 601 targeting EXO. So, what is the relative proportion of the sarcoma versus pancreatic cancer patients?
Speaker Change: will be enrolled and to be shown like data by the end of the year and also like any particular sub-tabs we're going to focus on sarcoma enrollment. Thank you.
Speaker Change: Yeah, so for sarcoma, we're focused on soft tissue sarcoma.
Speaker Change: And in terms of enrollment, actually both are enrolling at a pretty good pace, to be honest. I mean, as you know, there's...
Speaker Change: You know, very high access expression, so we don't even need to select patients for sarcoma, although it's rare.
Speaker Change: The not needing to select obviously 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've seen continued you know good enrollment and similarly with pancreatic
Speaker Change: Again, these tend to be very late-line patients, right, that have already failed, you know, multiple prior therapies. And, you know, the prognosis for these patients isn't great.
Speaker Change: So there we're doing an enriched strategy, we're looking at
Speaker Change: you know, 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 axomers versus those that don't. That's the work that's ongoing. I think we'll have a meaningful number in both of those tumors.
Speaker Change: In non-spousal 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-spousal lung cancer. As we've said previously, we expect that to come more in the first half of next year.
Speaker Change: Terrific, thank you very much.
Speaker Change: Thank you. Thank you.
Speaker Change: Michael Schmidt from Guggenheim is online with a question.
Michael Schmidt: Hey, good morning. Thanks for taking my questions.
Speaker Change: So, Roche recently reported positive data from their STAR-GLO study evaluating their T20 bispecific antibody and second line DL-BCL.
Speaker Change: How do you expect that to affect market dynamics in that setting and perhaps the opportunity from Zalanda? Obviously, you're evaluating both Lotus 5 and Lotus 7 studies in that same setting.
Speaker Change: 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 really a good approach.
Speaker Change: You know, so maybe just to talk about the implications of...
Speaker Change: of what Starglow is going to mean for both LOTUS 5 and for LOTUS 7. On the LOTUS 5 front, I think as you're aware, the primary endpoint is median PFS. And in our trial, we're doing Zymlanta plus Rituximab versus R-Jamox.
Speaker Change: 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.
Speaker Change: 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-5 because the study is powered with even a two-month difference to be a positive study. Obviously, we would hope to do much better than that because we want to make sure it's clinically relevant as well, but to us, that kind of...
Speaker Change: clearly showed that we believe Zinlanda can be better than the Gemox. If, you know, rituximab is obviously constant across both ARMS and MODIS-V, but we believe Zinlanda has the opportunity to prove to be better than Gemox.
Speaker Change: but also to do this where we don't have...
Speaker Change: We've not seen any new safety signals as we've reported before, but there's also no CRS, no ICANNs, and this makes it a very accessible option in the community, either in the second line setting.
Speaker Change: or even in the academic setting for those who progress and in the third-line plus setting so I think
Speaker Change: It's going to be a great combination. There's still a lot of R-based chemo use that exists within the community. And so Xenlanta Plus, we talked about, has the opportunity to provide better efficacy with a better tolerability profile than what exists today.
Speaker Change: Now, if you look at Lotus 7, you know, StarGlow obviously showed over 13 months of PFS with GlowFit plus GemOx.
Speaker Change: 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 going to need to be comparable or better from an efficacy standpoint. That's what matters most when you talk about more potent therapies like biophysical combinations.
Speaker Change: And so I think it clearly set a bar around that. But we believe this in lots in GloFIT, as we've seen in early data, and we hope to show with the expansion data.
Speaker Change: can have a synergistic or even additive effect. And, you know, when you look at the fact that it's in Laptoplus for Tuxenlab in our early safety running data showed already 50% CR rates.
Ameet Mallik: We're, you know, we're hopeful. Obviously, we believe GloFIT is significantly more potent than Britaxinab, and combining GloFIT plus Enanta has the opportunity to do even better.
Speaker Change: We're hopeful, obviously, we believe Glofit is significantly more potent than Protoximab, but combining Glofit plus Imanta has the opportunity to do even better. I mean, we're hopeful that we can approach the 60% range.
Ameet Mallik: 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 in the dose escalation, which is reduced rates and grades of CRS, which can hopefully enable broader accessibility. Yeah, I think there's an opportunity to improve on both the advocacy and safety profile of what has happened.
Speaker Change: 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 in the dose escalation, which is reduced rates and grades of CRS, which can hopefully enable broader accessibility.
Speaker Change: 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. You know, when you look at not only some of the toxicities with the bi-specific, which we hope to reduce,
Speaker Change: in the way we're dosing Zanlanta, but also at Genmox where you see cumulative, irreversible adverse events, including neurotoxicity and neuropathy. Yeah, I think there's an opportunity to improve on both efficacy and safety profile relative to that.
Speaker Change: Great. Thanks, Mallik. And then just regarding the marginal cell lymphoma and the follicular lymphoma interim data that you had presented, obviously looks super impressive.
Speaker Change: I'm 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.
Speaker Change: Yeah, I think it's possible before the presentation, but I think what it's going to require is, you know, a presentation at a major medical congress and a concomitant publication. I think whenever you want to submit to Guidelines, you do need a publication and a key medical journal.
Speaker Change: And of course, it's going to be data-driven and driven also by the investigators of the study.
Speaker Change: We've seen, you know, for example, in Marginal Zone, the latest, the last...
Speaker Change: BTK inhibitor, which is added to the guidelines in a preferred position.
Speaker Change: at 36 patients.
Speaker Change: 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 going to be very data-driven and driven by not only the efficacy that we see, but the durability of that efficacy.
Speaker Change: And then when there's a sufficient number of patients that 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...
Speaker Change: EFC Compendia Inclusion
Speaker Change: Yeah, makes sense. Thank you.
Speaker Change: Thank you.
Speaker Change: Brian Cheng from J.P. Morgan is online with a question.
Marcy Graham: Great. Thanks, Malik.
Unknown Questioner: 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 in guidelines prior to, you know, 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.
Ameet Mallik: Yeah, I think it's possible before the presentation, but I think what it's going to require is, you know, a presentation at a major medical congress and a concomitant publication. I think whenever you want to submit to guidelines, you do need a publication in a key medical journal. And, of course, it's going to be data-driven and driven also by the investigators of the study. Yeah, makes sense. Thank you.
Brian Chen: Hey guys, thanks for taking our questions this morning.
Brian Chen: Maybe just going back to Salon de 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?
Speaker Change: What are you seeing currently in Asia's markets and how confident are you that you will be able to see continued growth for the rest of the year? Thanks.
Speaker Change: Please stand by, your conference will begin momentarily.
Ameet Mallik: www.adclinic.com
Speaker Change: This concludes today's conference call. Thank you for participating. You may now disconnect.
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