Arvinas Inc Q3 2024 Earnings Call Transcript

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

Question: Manoj Eradath - Jefferies Financial Group Inc. - Analyst : Hi. This is Manoj in for Akash. Thanks for taking our question. So just one, should investors' base case be that Pfizer moves with their CDK4 combo with the vepdeg, not only for the first line, but also for the second line, why would IBRANCE or any other CDK4/6 combination be used at all in your pivotal studies if CDK4 inhibition shows meaningfully better hematotoxicity?

Question: Manoj Eradath - Jefferies Financial Group Inc. - Analyst : Should the base case be like Pfizer moves with the CDK4 inhibitor combo with vepdeg in the first line and second line?

Question: Manoj Eradath - Jefferies Financial Group Inc. - Analyst : Yes.

Question: Manoj Eradath - Jefferies Financial Group Inc. - Analyst : Yes, thank you.

Question: Brad Canino - Stifel, Nicolaus & Company, Inc. - Analyst : Good morning and thank you for the updates. Question for me on the upcoming abemaciclib combo data. Could you help frame that expectation relative to the palbo combo data you presented last year where you had the 11-month PFS, strong response rates, activity in both ESR1 mutant and wild type? Is that the bar as we think about additional CDK combos that you will be unveiling over the next several quarters in these pre-treated Phase 1b populations? Thank you.

Question: Brad Canino - Stifel, Nicolaus & Company, Inc. - Analyst : Got it. Thank you.

Question: Etzer Darout - BMO Capital Markets - Analyst : Great. Thanks for taking the question. Thank you for the updates today. Just a question around the fulvestrant control arm for VERITAC-2. We've gotten questions on that, sort of, if you could maybe frame your expectations? And do you think if there's anything we can read through to the Lilly upcoming data sets around where that control arm lands and where -- how it actually could perform for VERITAC-2? Anything incremental on your expectations around that? 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. OCTOBER 30, 2024 / 12:00PM, ARVN.OQ - Q3 2024 Arvinas Inc Earnings Call

Question: Etzer Darout - BMO Capital Markets - Analyst : Great, thank you.

Question: Ellie Merle - UBS Securities LLC - Analyst : Hey, guys, thanks for taking the question. So I guess into VERITAC-2, how are you thinking about the potential for success in the non-ESR1 population? And if you could sort of review the reasons you think that this could be successful? And then what do you think is the minimum threshold for success here on PFS to be able to get this broader label across ESR1 and non-ESR1 patients? Thanks.

Question: Ellie Merle - UBS Securities LLC - Analyst : Great, thanks.

Question: Li Watsek - Cantor Fitzgerald & Co. Inc. - Analyst : Hey. Good morning, guys, and thanks for taking our questions. I guess for the Phase 3 combo trials in front line and second line, wondering if you can elaborate a little bit on the key regulatory inputs that you still need before you nail down the final design? And how much of that is still dependent on the data that you need to generate?

Question: Ted Tenthoff - Piper Sandler Companies - Analyst : Great. Thank you very much. And thanks, guys, for hosting this call today. It's nice to get to hear from you and get the update. I know there's a lot going on. I know most of the questions have been on vepdeg, but just to ask with Novartis and 766, what's the latest there? And how do you and they anticipate advancing that in prostate cancer? Thank you.

Question: Ted Tenthoff - Piper Sandler Companies - Analyst : Thanks, John.

Question: Tazeen Ahmad - BofA Securities Inc. - Analyst : Thanks. Good morning. Maybe to switch topics to ARV-102, can you talk about the size of the PD population that you're specifically examining that have this elevated LRRK2? And how are you going to use the biomarker to determine segmentation of the population?

Question: Michael Schmidt - Guggenheim Securities Inc. - Analyst : Hey, thanks for taking my question. I just had a follow up on ARV-102 and the Phase 1 study. How should investors interpret the Phase 1 data in healthy volunteers next year? Are there specific PD markers perhaps other than LRRK2 degradation that you're assessing? And how predictive are those for potentially improving outcomes longer term?

Question: Tyler Van Buren - TD Cowen - Analyst : Hey, guys. Thanks for hosting the call. I just want to follow up on your response to an earlier question for the VERITAC-2 trial readout. So if the control fulvestrant arm does three to four months on median PFS and you hope to see a few months better per your earlier comment or a three-month plus delta in the ITT population or a near doubling, how do you expect median PFS to improve for both arms for the ESR1 population analysis?

Question: Jonathan Miller - Evercore ISI - Analyst : Hi, guys. Thanks for taking the question. I'd like to talk more about the vepdeg combo Phase 3s that you're talking about getting started next year. Can you contrast VERITAC-3 Phase 3 portion with these new Phase 3s that you're talking about? And it seems like the PR suggests you're focused on palbo and CDK4. It seems like you're not pursuing ribo or abema combos in first-line, at least it wasn't called out. So can you talk a little bit about how the data from -- what you're still waiting for from the TACTIVE trials to make the decisions about ultimate combo partner, a? And b, given the CDK4 combo data you mentioned will be available internally this year for use in deciding about those combination Phase 3, is it fair to expect that you would give some key details on the CDK4/vepdeg combo data when you decide on a Phase 3 course? Because I noticed you don't -- you haven't given guidance on when we could see that TACTIVE-K update.

Question: Khalil Fenina - The Goldman Sachs Group, Inc. - Analyst : Hi, everyone. This is Khalil calling in for Paul. Thank you so much for taking our question, and congratulations on the first earnings call. I guess a quick modeling question from us is, one, I guess, real quick is, as you have a lot of these earlier-stage assets entering the clinic or IND filings, how should we think about the cost ramp for next year, maybe the year after? And then just on the Novartis agreement, given the revenue recognition that you had this quarter, are we correct in thinking there's about $930 million in additional payments? Or is that -- how do you -- how should we think about like the cadence of that going forward? Thank you so much.

Question: Khalil Fenina - The Goldman Sachs Group, Inc. - Analyst : Yes, of course. So just given that we assume that the $120 million upfront payment has already occurred and then you reported today like $67 million or so in revenue from that agreement, our understanding is that there's a total of about $1 billion-ish in payments that are contingent on certain milestones. Obviously, those I don't think have been disclosed, but we were just wondering if you could share any color on how we should think about the cadence of revenue from that agreement in 2025? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 30, 2024 / 12:00PM, ARVN.OQ - Q3 2024 Arvinas Inc Earnings Call

Question: Khalil Fenina - The Goldman Sachs Group, Inc. - Analyst : Got it. That's really helpful. Thank you so much.

Question: Yigal Nochomovitz - Citigroup Inc. - Analyst : Hi, thank you for taking the questions. I just wanted to follow up on some of the questions regarding the front-line strategy and the comments Noah was making on contribution of components. So if it turns out that you pick -- you and Pfizer pick atirmo plus vepdeg, are you going to be able to do a trial where it's atirmo/vepdeg versus palbo/fulvestrant? Or given the consideration of contribution of components, is it going to potentially be more complicated with including a palbo/vepdeg arm as well as an atirmo/fulvestrant arm? I'm not sure how that would work, if you could comment. And then I'm just also curious if you've generated data today to support the fact that you won't have a DDI with atirmo and vepdeg. Thanks.

Question: Yigal Nochomovitz - Citigroup Inc. - Analyst : Okay, appreciate it. Thank you very much.

Question: Billal Jahangiri - Truist Securities, Inc. - Analyst : Hi, thanks for the call. This is Bill on for Kripa. We were wondering what's going to be the final deciding factor or maybe factors on choosing which combo to take forward? Is it strictly on efficacy? Or is there some sort of strategic IP factor involved too that you're thinking of as well? Thanks.

Question: Billal Jahangiri - Truist Securities, Inc. - Analyst : Great, thanks.

Question: Matt Biegler - Oppenheimer & Co. Inc. - Analyst : Hey, guys, thanks for squeezing me in. I realize we're at the top of the hour. It's like covering a large cap with a number of analysts here. I just wanted to ask about the statistical plan for VERITAC-2 to the extent you can tell us. Is it hierarchical testing? Or are the co-primary endpoints effectively the alpha split between them, between the ESR1 and the ITT population? And secondly, do you think a 0.7 hazard ratio would be good enough for an all-comers label? Thanks.

Question: Matt Biegler - Oppenheimer & Co. Inc. - Analyst : The hazard ratio?

Question: Matt Biegler - Oppenheimer & Co. Inc. - Analyst : Appreciate it. Thank you.

Question: Michael Schmidt - Guggenheim Securities Inc. - Analyst : Hi, guys. Thanks for taking the follow up. I just had a clarification question regarding your earlier comments on VERITAC-2. I think you said you expect about three to four months PFS for fulvestrant in the control arm. And yes, I was just wondering what are -- or are there any major differences in enrollment criteria relative to the post-MONARCH trial where fulvestrant obviously did much better than that?

Question: Michael Schmidt - Guggenheim Securities Inc. - Analyst : Great. Yes, it makes a lot of sense. I really appreciate that clarification.

Question: Jonathan Miller - Evercore ISI - Analyst : Hi, guys. Thanks so much squeezing in my follow up here. I figured since nobody has asked about it, I'd love to ask one question about the upcoming KRAS PROTAC programs that you're working on, the G12D and the pan-KRAS that you discussed during your prepared remarks. Can you compare these programs to other G12D or pan-KRAS approaches? And how do you think a degrader is going to be better suited than some of the other approaches, notably the inhibitors? How will a degrader compare to a RevMed-like molecular glue pan-KRAS approach?