Arvinas Inc Q4 2024 Earnings Call Transcript

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

Question: Derek Archila - Wells Fargo Securities, LLC - Analyst : Just one in terms of just the TACTIVE-U cohorts that you'll be reading out this year. You think about the cadence of that data across different medical meetings. And ultimately, are you waiting for that data to really decide on the second-line CDK4/6 combo?

Question: Derek Archila - Wells Fargo Securities, LLC - Analyst : Understood. And if I can squeeze one more on LRRK2, just in terms of what you plan to share for the SAD. I guess, what level of degradation do you find to be therapeutic in the pre-clinical setting and how will that translate to the human setting? Thanks.

Question: Derek Archila - Wells Fargo Securities, LLC - Analyst : Excellent. Thanks again. Congrats on the progress.

Question: Jonathan Miller - Evercore ISI - Analyst : I guess since we just had a question on the Phase 3 and the second-line getting factors, I'll ask on the first line. Obviously, you've already chosen the CDK combo here with the CDK4. What's the gating factor to getting that study started? How much data do you need in the atirmo combo at TACTIVE-K before you can make those trial design assumptions? Do you need six months' data to go to the FDA with a trial design for Phase 3?

Question: Jonathan Miller - Evercore ISI - Analyst : Great. And maybe if I can squeeze one more, I know you're not answering questions about VERITAC-2. But could you talk to commercial preparations beyond what we assume is going to be a wonderful readout in a couple of weeks? How is your commercial prep going and what do you think ramp there needs to be ready for a launch?

Question: Li Watsek - Cantor Fitzgerald - Analyst : I wonder if you can maybe just comment on VERITAC-2, if it has any readthrough to the two Phase 3 trials that you plan to initiate this year. Any elements of the trial design might be impacted by the results?

Question: Li Watsek - Cantor Fitzgerald - Analyst : Understood. And I guess just from a pipeline perspective, you've got three additional programs that you're moving forward into the clinic. So I guess what level of investment that you guys are looking to make, especially for the larger indications like Parkinson's disease.

Question: Akash Tewari - Jefferies - Analyst : So I just previously mentioned that the decision to progress the vepdeg-CK4 combo would be in part an efficacy-based decision. We know we're going to a first line right now. With that in mind, can you frame expectations on that upcoming combo data? Will we have enough follow-up to give an early take on CFS? And if not, what do you think response rate should be for both a first-line and second-line setting for your go-forward dose? And then on VERITAC-2, this isn't a timing question. But how concerned are you that a six-month prior ET requirement is not sufficient to remove ET fast progressors? And what percent of fast progressors do you expect in your study versus what we saw with Lily?

Question: Tazeen Ahmad - BofA Global Research - Analyst : Okay. I think that's me. So maybe I have a couple of questions. The first one is metastatic breast cancer. So what data do you think you'll need to show to give confidence to KOLs on the profile of that and atirmo, just considering that historically, they will have had a lot more experience with the other CDK inhibitors like ribo and palbo, for example? And then I have a follow-up.

Question: Tazeen Ahmad - BofA Global Research - Analyst : Okay, got it. And then if I could ask a question on your KRAS degrader, can you talk about how you think it might be differentiated given that this G12 degrader space is pretty competitive? You've got other companies like Astellas in the clinic. And what would you want to see in order to move it forward?

Question: Srikripa Devarakonda - Truist Securities - Analyst : My first question is on ARV-393. Can you talk a little bit about enrollment status for this program and whether there's any focus on a particular subset of NHL patients? And given the profile of the target, where do you think this might fit into the landscape with other targets like BTKs or BCL2? Thank you. And I have a follow-up. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 11, 2025 / 1:00PM, ARVN.OQ - Q4 2024 Arvinas Inc Earnings Call

Question: Srikripa Devarakonda - Truist Securities - Analyst : Great. We'll keep an eye out for AACR. Just a follow-up question. We got some inbound around the Chief Commercial Officer leaving right before a key readout and potentially a year or so before potential commercial rollout. Can you talk a little bit about it and help alleviate investor concerns about this?

Question: Jeet Mukherjee - BTIG - Analyst : I was hoping you could elaborate a bit more on what we can expect from the Parkinson's patients update for ARV-102 later this year. And are there any biomarkers you'd be looking for that would translate to functional improvements in these patients? And I had a follow-up.

Question: Jeet Mukherjee - BTIG - Analyst : Understood. That's helpful. And maybe a VERITAC-2 question if you just wouldn't mind. You said you'd present full results at a medical conference. Would any abstract embargo rules potentially limit what you could say as part of a top-line press release? Thanks.

Question: Brad Canino - Stifel Nicolaus and Company, Incorporated - Analyst : Listening to the large pharma earnings, we should expect front-line Phase 3 oral CERD trials in combination with the CDK4/6 inhibitors from Roche and AstraZeneca this year. That's right around the time you and Pfizer will be kicking off the front-line vep-CDK4. How will Arvinas think about these results of the studies as they pertain to your front-line plan?

Question: Sudan Loganathan - Stephens Inc. - Analyst : And my first one would be on atirmociclib. In regards to that first-line combination, you're playing with that, I think. I think atirmociclib is uniquely characterized by like a 20-fold and fourfold increase in productivity for CDK4 over CDK6, which -- I believe that probably helps with the neutropenia or any hematologic toxicities that may have showed up with like palbociclib, potentially. But I'm curious to see how you view the glucose metabolism component for CDK4 involvement in that and how that may play out in the safety profile and just -- even just your very broad view on what makes atirmociclib, in your view, better than palbociclib, ribociclib, or any of the other CDK4/6 inhibitors out there. And then I have a follow-up.

Question: Sudan Loganathan - Stephens Inc. - Analyst : Great. No, I appreciate the insight there. And my second one is in regards to the BCL6 degrader, ARV-393. Could you share your perspective on the potential efficacy and utilization of the PROTAC technology in comparison to Bristol-Myers Squibb's BMS-986458, I believe, which employs the ligand-directed degradation for B cell malignancies, and if your strategy has evolved or changed in response to any preliminary data that BMS has provided up to this point with their degrader?

Question: Ted Tenthoff - Piper Sandler Companies - Analyst : I'm excited for all the data this year. Similar question to those asked earlier about how the front-line treatment paradigm is changing, but to the second line. How are you guys seeing -- like with the CERDs and the CDK4/6 up front in first line, how are you seeing the second-line treatment paradigm changing ahead of vepdeg monotherapy data and VERITAC-2 data?

Question: Ted Tenthoff - Piper Sandler Companies - Analyst : Okay, great. That's really helpful. I appreciate that color. I'm looking for data from the rest of the pipeline, too.

Question: Ellie Merle - UBS - Analyst : Just in terms of the front-line setting for vepdeg, how are you thinking about potential enrichment strategies for patients who might be more responsive to an oral CERD and your latest thinking on what the predictors are of which patients might develop an ESR1 mutation? And then I have a follow-up.

Question: Ellie Merle - UBS - Analyst : And then just a follow-up, maybe just a broader strategic question. There's been a lot of focus on STAT6 as a target for degraders. But obviously, there aren't so many companies that have expertise in making degraders. What's your perspective on whether you might expand your focus to targets or, say, a target in the immunology space? And just from a platform perspective, what's the latest on how long it would take from, say, selecting a target protein to making a PROTAC development candidate?

Question: Paul Choi - Goldman Sachs - Analyst : I had just a couple quick ones on ARV-393. Can you maybe just comment on what you'd like to see from your initial clinical data in patients that's coming up later this year to think about potential expansion into the post-stem cell population or maybe other subpopulations such as the elderly who are traditionally too fragile for standard of care such as R-CHOP? And second, can you just confirm if that initial Phase 1 data will either be at EHA or ASH? Any clarity there would be great.

Question: Paul Choi - Goldman Sachs - Analyst :

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : I'm sorry. A couple more on vepdegestrant. Are you planning to present any of the VERITAC-3 lead-in data with palbo this year? And are there any learnings in terms of efficacy from that experience that can perhaps be applied to the design of the planned Phase 3 study with atirmociclib? And then for VERITAC-2, as we are trying to contextualize Lily's [EMBR3] data from last December, perhaps relative to the post-MONARCH data from ASCO, what is your base case assumption for PFS in the full vestibular control arm in ITT? And is there one mutant subset for that study?