Incyte Corp Q4 2024 Earnings Call Transcript

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

Question: Paul Jeng - Guggenheim Securities, LLC - Analyst : Hey, good morning. Thanks for taking our question. This is Paul on for Michael. We have two on the pipeline. First on Opzelura. Can you set some expectations for the upcoming Phase 3 in prurigo nodularis? What's the clinical bar here given there's no topical therapies available? And then secondly, just on the CDK2 program. Are there any plans to provide another clinical update on the Phase 1 ovarian cancer study, perhaps with longer follow-up at the expansion dose levels? And what are the gating factors to formalizing a pivotal study dose selection? Thank you.

Question: Tazeen Ahmad - BofA Global Research - Analyst : Hi guys, good morning. Thanks for taking my questions. As it relates to Opzelura, can you give us a sense of how you got to guidance for this calendar year, specifically, how are you thinking about the number of tubes that are going to be used for the two approved indications? And then maybe one question on povo or for the HS data that's due in the first half of this year, what would you consider to be not only statistically significant but also clinically meaningful data? Thanks.

Question: David Lebowitz - Citi Investment Research - Analyst : Thank you very much for taking my question. Given the IRA out-of-pocket has moved to its go-forward levels, 1,000 per year, can you run us through what the processes that a patient must go through to actually ensure that the cap is put in place. What steps do they need to take? And how long do you think it might be until the benefit of that starts showing up in sales?

Question: David Lebowitz - Citi Investment Research - Analyst : Thanks for taking the question.

Question: Jessica Fye - JPMorgan - Analyst : Hey guys, good morning. Thanks for taking my questions. A couple on povo in HS. So I think north of 60% of the patients in your Phase 3 trials are biologic-naive. Are you going to seek a label that includes biologic-naive patients? Or do you expect it will be labeled for post biologic patients? And then within the trials, are you powered for both the biologic naive and experienced subgroups? And is there anything you can say about the powering assumptions there?

Question: Jessica Fye - JPMorgan - Analyst : Pablo, can I follow up on one of the responses to, I think it was Tazeen's question. When you said, if you show something that's close to what you showed in Phase 2, that would be super competitive. Because I think the Phase 2 deltas on HiSCR50 differed a little bit, if you look at the 16-week versus the 12-week time point. And I think in Phase 3, it's a 12-week. So when you say close to Phase 2, do you mean close to the 12-week cut of Phase 2 or close to the 16-week?

Question: Salveen Richter - Goldman Sachs & Company, Inc. - Analyst : Good morning. Thanks for taking my question. Just a follow-up here on povo. With regard to the Phase 2 data, and we saw this drop from week 12 to week 16. Could you just speak about the read-through to this trial and the risk that may play out there? And then also in your 2025 guidance, just speak to us about how you model for Part D redesign for Jakafi? Thank you.

Question: James Shin - Deutsche Bank Securities Inc. - Analyst : Hey, good morning, guys. I just wanted to follow up on povo STOP-HS1 and 2 Phase 3 trials. How will you disclose this data? Will we get a press release with HiSCR top line followed by full data at the medical conference? And then any update on the X2 program for CSU? Thank you.

Question: Vikram Purohit - Morgan Stanley & Co. LLC - Analyst : Hi, good morning. Thanks for taking our questions. We had just one on the proof-of-concept data sets expected for [you and keller] then also for JAK2V617Fi for later this year. Could you just help us kind of frame what we can expect to learn and what you're setting at the bar for success for these data sets and what the hurdle is going to be for moving these programs forward?. Thank you.

Question: Marc Frahm - TD Cowen - Analyst : Hey, thanks for taking my questions. Maybe just a one nuance question on Stop-HS. Just Pablo, you mentioned earlier often these trials do have a little bit of a decline in treatment effect from Phase 2 to Phase 3. In HS specifically, we've seen kind of changes in antibiotic use and how that's treated with an SAP to maybe drive some of that effect. Can you remind us just how antibiotic use is being treated, what's treated in Phase 2 and how that may or may not differ in the Phase 3 trial? And then for Christiana, on the absolute guidance, can you break down some of the assumptions there on US versus ex US growth, just given the kind of label changes that are happening, but also increasing reimbursement outside the US?

Question: Kelly Shi - Jefferies LLC - Analyst : Thank you for taking my questions. I have two. Firstly, can you share a little bit more color on [KRASG21D] program. In terms of POC data, what kind of like sample size and also tumor indications could we expect? And also based on the preclinical data achieved so far, do you think it hints any potential differentiation from other competitive G12D programs? And for Pablo, just quickly, I want to confirm, for the HiSCR75, 90 and 100,

Question: Brian Abrahams - RBC Capital Markets Wealth Management - Analyst : Hey, good morning. Thanks for taking my question. Maybe on the BET inhibitor, can you talk about the role you foresee for that in a post-Jakafi amount of therapy setting? And then what's your latest thinking on the frontline development path? What are you looking for out of the treatment that you've combo data to move forward? And are we still looking for results from that this year? Thanks.

Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst : Hey congrats on the quarter. For ruxolitinib XR -- also congrats on achieving bioequivalence. Can you just talk about your plans to commercialize rux XR and also the timeline for a fixed-dose combination with your BET inhibitor? Thank you.

Question: Matt Phipps - William Blair & Company, L.L.C. - Analyst : Yeah, thanks. Two for me. One, can you maybe just remind us on the learnings from the robust trial that were incorporated into front line where you think you can succeed when that trial fails? And then for the mutant-CALR program, is that just going to be monotherapy this year? Or could we also get some Jakafi combo? And can you remind us preclinically, if you saw any differential activity between type 1 versus type 2 mutations in CALR. 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. FEBRUARY 10, 2025 / 1:00PM, INCY.OQ - Q4 2024 Incyte Corp Earnings Call

Question: Andrew Berens - Leerink Partners - Analyst : Hey, thanks. Congrats on the good quarter in 2024. A couple more on Jakafi XR. I don't think you commented on the Cmax. Just wondering how that would looked as increase the dose to Cmin. And is there anything else that's gating approval either in the stability studies?

Question: Andy Chen - Wolfe Research, LLC - Analyst : Hey, thank you for taking the question. So on povo HS again, can you talk about specific protocol differences between your trial and other trials, especially from IL-17 antibodies? What have you learned from the trials? And what might you be doing differently to amplify your efficacy here? And then also in your base case scenario, are you expecting only the high dose to be approved or both doses? 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. FEBRUARY 10, 2025 / 1:00PM, INCY.OQ - Q4 2024 Incyte Corp Earnings Call

Question: Evan Seigerman - BMO Capital Markets - Analyst : Hi guys, thank you so much for taking my questions. Two for me. Just walk me through some of the initial assumptions for the pediatric Opzelura launch? What does this initial uptake curve look like? And how much is factored into your guidance? And second, kind of a hypothetical here. Would you ever consider an adalimumab head-to-head trial in HS versus povo, given that you want to establish yourself as a systemic standard of care in this market. I'm just thinking if this is a biosimilar market, you're coming in as a branded, and it could help you kind of getting a leg up here. 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 10, 2025 / 1:00PM, INCY.OQ - Q4 2024 Incyte Corp Earnings Call

Question: Ash Verma - UBS Investment Bank - Analyst : Great, thanks for taking my question. Just one. So on povo and HS, I wanted to understand what is your view of the potential upcoming readouts from competitors? You have [LIMBER]. How would that impact your value proposition for povo in this market? Thanks.

Question: Kripa Devarakonda - Truist Securities - Analyst : Hey guys, thank you so much for taking my question. On Jakafi, it think like PV is primarily driving growth. Can you talk about the patient population where you're getting uptake? And what the expectations are in terms of growth? Is it primarily through new patient adds or duration on therapy as well? And beyond rux XR and the V617F inhibitor, any additional life cycle management plans for your footprint in PV, which seems to be growing? 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 10, 2025 / 1:00PM, INCY.OQ - Q4 2024 Incyte Corp Earnings Call