Incyte Corp Announces Positive Topline Results From Two Phase 3 Clinical Trials- Conference 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 my questions. I had a question perhaps for the physician on the call. Could you talk about how these top-line results for povorcitinib and the overall profile perhaps in HS position the drug relative to the biologics that are on the market? And what percentage of patients do you think would ultimately be candidates for this therapy in your opinion? Thanks so much. Unidentified Company Representative Joslyn?

Question: Tazeen Ahmad - BofA Global Research - Analyst : Okay, great, thanks for taking my question. This is also for the physician. If you have to compare it to other treatments available right now in the market to treat patients versus ones that could also come on to the market, what percent of patients do you think you would recommend this drug to today? And then if I could, could I ask the Incyte team what the gating factors are remaining for the filing of the sNDA? Because you said you're not going to potentially get to that until end of this year or early next.

Question: David Lebowitz - Citi - Analyst : Thank you very much for taking my question. When you have a patient -- new patient coming into practice, and you are opposed with this data for the oral versus the data we've seen to this point with the biologics, what goes to your decision-making process in determining how you choose the biologic or the oral for their first option?

Question: Jessica Fye - JPMorgan - Analyst : Hey, guys, good morning. Thanks for taking my question. Maybe kind of following up on this topic around where the product could be positioned in biologic naive versus experienced patients. Do you think the label for povo will include biologic naive or be confined to biologic experienced patients? And then do you think the data for the biologic experience subgroup could get on the label? 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. MARCH 17, 2025 / 12:00PM, INCY.OQ - Incyte Corp Announces Positive Topline Results From Two Phase 3

Question: Jay Olson - Oppenheimer & Co., Inc. - Analyst : Hey, thank you for providing this update. We have a question about dose response, which seemed clear in Phase 2, but in both of these Phase 3 studies, the 45 mg and 75 mg doses had similar activity at 12 weeks. So can you talk about any reasons why there was less dose response in these studies? And since most patients should have been in the studies for a while, can you comment on high-level efficacy beyond week 12 and whether or not you saw any dose response after week 12?

Question: Matt Phipps - William Blair & Company - Analyst : Good morning. Thanks for taking my question. As the day stands today, I guess, do you see any reason to commercialize both the 45 and 75 mg dose, given particularly the similar efficacy in 75 mg have higher levels of acne? And then I realize a bit of a different patient population, but any learnings from the STOP-HS trial that can be used to maybe tweak the Opzelura trials in the more moderate HS population?

Question: Marc Frahm - TD Cowen - Analyst : Thanks for taking my question. Maybe just on the idea of the efficacy being a little bit better in the biologic experienced patients. Can you speak to what fraction of the biologic experienced patients have seen IL-17 inhibitors versus just TNF? And does that same pattern of efficacy being a bit better kind of hold in the IL-17 experienced population? Or is it mostly confined to the TNF experienced population? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 17, 2025 / 12:00PM, INCY.OQ - Incyte Corp Announces Positive Topline Results From Two Phase 3

Question: Marc Frahm - TD Cowen - Analyst : Okay, thanks. It's helpful.

Question: Derek Archila - Wells Fargo Securities, LLC - Analyst : Hey, good morning, and thanks for taking the questions. This question is for Dr. Kirby. I guess do you think the non-safety data generated so far from povo and HS is sufficient for use in naive patients? I guess, is your view that povo would probably largely used just in experienced patients?

Question: Brian Abrahams - RBC Capital Markets - Analyst : Hey, good morning, guys. Thanks so much for taking my question. Can you remind us of the imputation methodology used in this study for patients who may have discontinued or needed to start antibiotics? How that compares to the other contemporary Phase 3 HS studies and maybe how that played into the results at all?

Question: Kelly Shi - Jefferies - Analyst : Thank you for taking my questions. Maybe for Dr. Kirby, would you consider using povo in combination with other biologics given the high unmet need for HS? And also, how do you integrate higher stringent endpoints like HiSCR 90 and 100 along with 50 and 75 to reassess the overall efficacy profile of povo?

Question: Srikripa Devarakonda - Truist Securities - Analyst : Hey, guys, thank you so much for taking my question. I was wondering if you have a sense of percentage of patients who have comorbid disease that could preclude a JAK inhibitor, not knowing whether povo is going to get a black box learning or not. Safety looks good now, but in that context. And given what we have seen with the Phase 2 data, do you have a sense of how long the patient could be on a drug? How comfortable would you be keeping the patient on the drug for?

Question: Andy Chen - Wolfre Research - Analyst : Hey, thank you for taking the question. It's another question for Dr. Kirby. If you can take a five-year view into the future of HS, by which time we most likely have secukinumab biosimilars, my guess is that payers will require adalimumab and secukinumab biosimilars first. So the question is, after these biosimilars, would physicians prioritize potentially a stronger bimekizumab? Or would you try povorcitinib, which is a different mechanism? So I know you mentioned that treatment selection is often aligned with patient preferences, but I don't think patients really think about mechanisms.

Question: James Shin - Deutsche Bank - Analyst : Hey, good morning, guys. Thanks for the question. One for Dr. Kirby. A lot of emphasis on pain, rapid pain addressing the pain. What proportion of patients would opt for safe povorcitinib versus, say, [Bimzelx]? And then related to the trial, was there -- what was the increase in lipids and cholesterol? Was it in line with JAKs, the previous JAKs?

Question: Malcolm Hoffman - BMO Capital Markets - Analyst : Hi, Malcolm Hoffman on for Evan. Thanks for taking my question. Looking at the reduction of flares, it looks like both 45-milligram and 75-milligram doses were not satisfied for HS1. Can you talk about how meaningful or not meaningful this is? Could this be a point of that physicians pause on? Or do you think -- now expect this to be a meaningful detractor? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 17, 2025 / 12:00PM, INCY.OQ - Incyte Corp Announces Positive Topline Results From Two Phase 3

Question: Reni Benjamin - Citizens - Analyst : Hey, guys, thanks for taking the questions. The rapid onset is a standout feature. Can you just quantify how quickly patients saw benefits? Like did they see it even earlier than week 3? And how this differentiates versus, let's say, biologics? And just a related question. In the subgroup of patients that were naive, was that group statistically significant? Or was the positive results for the entire intent to treat really driven by those that were exposed by or exposed to biologics prior?