Arvinas Inc Q1 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Michael Schmidt - Guggenheim Securities - Analyst : Hey guys, good morning. Thanks for taking our questions. I just had a few follow up questions on Vepdeg. Maybe just help us understand a little bit more on how much of the decision to not advance the CDK4/6 inhibitor combinations was driven by emerging data on the class overall versus specifically the VERITAC-2 results. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 12:00PM, ARVN.OQ - Q1 2025 Arvinas Inc Earnings Call And in the second line setting, how do you think Vepdeg will be positioned relative to other oral (inaudible) and help us understand how much you need to invest in a commercial infrastructure as you potentially maybe co-commercializing the product in the US next year. Thanks so much.

Question: Andrew Berens - Leerink Partners - Analyst : Hi, thanks, and I'm sure you guys have had to make some difficult decisions over the last few weeks. So my question is about the future neuro efforts in LRRK2. You did give some color and prepared comments about the role of LRRK2 in neuro diseases, but wondering how much LRRK2 degradation you think is going to be clinically relevant and whether these would eventually be combination approaches.

Question: Andrew Berens - Leerink Partners - Analyst : Okay, and do you think it'll be a combination eventually?

Question: Andrew Berens - Leerink Partners - Analyst : Right. I'm asking whether you think it'll be on top of standard of care currently.

Question: Andrew Berens - Leerink Partners - Analyst : Yeah, okay. Thank you.

Question: Derek Archila - Wells Fargo Securities - Analyst : Results, like what type of results can we expect to see?

Question: Jonathan Miller - Evercore ISI - Analyst : Hi guys, thanks for taking my question. I'll do one more on vepdeg maybe since we haven't spoken about the first line potential there. You were a little more vague about the rationales for not proceeding with the [atirmociclib] Phase 3. Is your expectation that next gen estrogen receptor directed therapies are not going to be relevant in first line in general or is this more to do with vepdeg's profile or more to do with the (inaudible) profile or the data that you've seen in the combinations so far? So maybe I guess I'll start with that. And then secondly. On the BCL-6 program, how much data in NHL patients can we expect to see in the next handful of releases, and would you expect to be able to show ORRs or at least meaningful efficacy data that will allow us to comp to other recent NHL data sets?

Question: Jonathan Miller - Evercore ISI - Analyst : Do you expect to be --

Question: Jonathan Miller - Evercore ISI - Analyst : Do you expect to be in the active dosing range? Would you expect to be reaching dose levels that that are where you want them to be from the perspective of the level of degradation you're expecting to drive efficacy?

Question: Jonathan Miller - Evercore ISI - Analyst : Alright, thanks so much.

Question: Tazeen Ahmad - Bank of America - Analyst : Okay, I have a few questions as well. I think a few minutes ago you had talked about the market op opportunity for these, VERITAC-2 patients that that were positive in the study. You mentioned that for (inaudible), one third of the 25,000 patients are on that drug. Does your market data give you any feedback about what the profile of those one third of patients are, and is there anything different about the other two third, that could makeeptech potentially more attractive, for patients. And then, can you just provide any color on the remaining Pfizer milestones you expect to realize from here on out, and if there are any specifically related to the [KAT6] collaboration. And then the last one, I'm sorry if I missed this, but are you still planning on exploring Vepdeg in third line (inaudible)?

Question: Peter Lawson - Barclays Investment Bank - Analyst : Great. Thank you. Thanks for taking the questions. Just a couple of questions on the commercialization. So Vepdeg, have you kind of worked through the size of the sales force you need? And then your comments just around, Vepdeg in first line. Does the Pfizer partnership preclude you from going off and finding a different partner to run that first line study? Just if you could walk through kind of that process of potentially rekindling for a first line study.

Question: Peter Lawson - Barclays Investment Bank - Analyst : Thank you. And then just on the KAT6 combination, is that under the same kind of profit share terms of agreement with Pfizer or is that a separate entity? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 12:00PM, ARVN.OQ - Q1 2025 Arvinas Inc Earnings Call

Question: Peter Lawson - Barclays Investment Bank - Analyst : Great. Thanks for taking the questions.

Question: Paul Choi - Goldman Sachs - Analyst : Hi, thank you, good morning everyone, and thanks for taking the question. I just want to ask if you have any sort of gating items or any remaining things to do prior to scheduling your pre-NDA meeting, and will that come presumably post-ASCO here or just some clarity on the color of when you plan to meet with FDA would be helpful as part of your second half of this year filing timeline. And my, second question is just on the LRRK2 program in in Parkinson's just sort of when the next sort of data update could potentially be expected from that program. I think you know the early data that you presented looked interesting and promising. Just curious sort of what timelines for the next data set might be. Thanks for taking our questions.

Question: Paul Choi - Goldman Sachs - Analyst : Okay, thank you very much.

Question: Srikripa Devarakonda - Truist Securities, Inc. - Analyst : Hey guys, thank you so much for taking my question. I have a couple, first for ARV-393. I know you're currently enrolling Phase 1 trial, just wondering how easy it has been to enroll patients. You do seem to have a lot of centers open. And also based on the recent preclinical combo data that you presented at AACR, are you getting a better sense of where you think the drug and the combinations might fit in the landscape. And then just a question on your FDA communications with some of the changes happening at the FDA, is there any concern in terms of delayed timelines for meetings or review processes? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 12:00PM, ARVN.OQ - Q1 2025 Arvinas Inc Earnings Call

Question: Yigal Nochomovitz - Citigroup - Analyst : Alright, great, thank you very much for taking the questions. I have 3 questions. So the first one is, given the combo with the KAT6 and the Vepdeg, have you or Pfizer produced any preclinical work that would support that combo, or could you discuss the rationale for that combo on a scientific medical basis? Second question is. We haven't talked much about supply chain. Could you just review the structure and geographic location for the manufacturing supply chain for Vepdeg as well as where the IT is domiciled? And then the last question, John, you gave a very comprehensive answer with respect to the rationale for Pfizer stopping the frontline study. I'm just wondering if the factors related to the novel combo with the turmo as well as the potential to do or need to do a forearm study perhaps to tease out contribution of components was a relevant factor in that decision or not. Thank you.

Question: Yigal Nochomovitz - Citigroup - Analyst : Okay, thank you very much.

Question: Malcolm Hoffman - BMO Capital Markets - Analyst : Hi, this is Malcolm Hoffman on for Evan. Thanks for taking our question. I was thinking about the LRRK2 degrader again. I know by just announced today that enrollment in their Phase 2 study is now complete with results in 2026. I just wanted to ask how you are starting to think of the competitive positioning for your degrader versus others and what your confidence is that yours could be differentiated versus slightly more advanced programs. Thank you.

Question: Malcolm Hoffman - BMO Capital Markets - Analyst : Appreciate you guys, thank you.

Question: Li Wang Watsek - Cantor Fitzgerald & Co. - Analyst : Hey guys, thanks for taking our questions. Maybe a BD strategic question. Are you open to bringing in the external assets just given your balance sheet, and then you got three earlier assets in the pipeline, maybe talk a little bit about your conviction and development strategy there. Sounds like you're going to have some data later this year where you'll be making some decisions then. And then secondly just for the KAT6 combo, when should we expect to see the data and then what would be the bar that you have to head, given it's early Phase 1 trial. And then, can you clarify, is it going to be in the ESR1 mutant patients or it's going to be in [all commerce]. Thank you.

Question: Jeet Mukherjee - BTIG - Analyst : Great, thank you for taking the question. Was wondering if you've thought about potential NCCN guideline inclusion for some of your Vepdeg CDK4/6 data to support combination use just given some of the notable PFS data you had shown at San Antonio 2023 and thereby allowed doctors to use a CDK4/6 off-label in combination with Vepdeg in the second line setting. And My second question was just around your G12D degrader. Can you maybe talk about how that compares to [Stela's] degrader and some of the perhaps subpar efficacy and safety it had shown at last year at ESMO. Thanks.

Question: Sudan Loganathan - Stephens Inc. - Analyst : Hi, good morning, and thank you for taking my question this morning. I wanted to kind of dig deeper into the details for the ESR1 mutant patients again, that are naive to treatment. I believe you mentioned earlier on the call about approximately 5% are of ESR mutant is in the first line setting. Is Vepdeg with the monotherapy design actually going to be well positioned to be more of the standard of care even also in the first line that kind of demonstrate the ESR1 mutant as well, or will there be some additional trials or anything else that needs to be done there? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 12:00PM, ARVN.OQ - Q1 2025 Arvinas Inc Earnings Call And then with the total of about 40% I guess of second line patients at ESR mutant, is that only specific to first line patients that were treated on CDK4/6 inhibitors or also other treatments as well? Thanks.

Question: Sudan Loganathan - Stephens Inc. - Analyst : I appreciate it thanks for the clarity there.