Incyte Corp at Guggenheim Global Healthcare Conference Summary

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

Question: Michael Schmidt - Guggenheim Securities - Analyst : <_ALACRA_META_ABSTRACT>So maybe just starting out of the high-level question, how has Incyte's R&D strategy and pipeline evolved in the last year or so? And what are some of the initiatives that you have implemented since joining the company?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. And can you talk about how you're balancing allocating resources internally versus looking at external source of innovation. How do you balance capital allocation, perhaps as we think about additional acquisitions like the transaction that was announced earlier this year?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And so in this context, was the share repurchase a onetime thing? Or is it something that could you envision, taking advantage of, in the future again?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. Okay. Superb. So Pablo, I wanted to talk about a few of your pipeline agents. And by the way, we have more time than the minutes up there. So just as a heads-up. So I'm going to run through the list essentially. So maybe just starting out with Jakafi XR. And so the question there is how do you think about Jakafi, the long-acting or once-daily Jakafi opportunity. Is that still a focus? Is there still a focus on perhaps extending Jakafi's life cycle beyond mid-2028, taking advantage of the long-acting form?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. So maybe a good segue to talk about your BET inhibitor, which, again, I think you previously already committed to sort of moving that into Phase III. And just in context of the reason disclosures from Novartis on some of the trial imbalances potentially in sort of secondary malignancies. Has that changed at all how you look at your program and in terms of advancement?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And just remind us what additional clinical data you have been generating relative to last year's ASH presentation and how those data will support your planned Phase III program?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And so looking at last year's data, there actually was activity as a single agent as well. And so is there a single-agent opportunity? Or should we think about more of a Jakafi combination?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. So we'll look forward to that. And then the ALK program is the other program that could potentially enhance sort of Jakafi's activity further? And just remind us where you stand with that and sort of what we should expect here at ASH for that?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. And then just sticking with MF. So the mutant-CALR antibodies, one that I think was highlighted preclinically at ASH a couple of years ago, you're in Phase I for some time now. And just remind us again, why is it so interesting as a target? And where are you in your Phase I study?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Can you talk about what are you looking for in Phase I? Is it as simple as SVR35? Or are there other markers that are important?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. And then ultimately, how would this be developed? Would this be an add-on to Jakafi or before or maybe after Jakafi initially?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. And then where does your JAK2 selective V617F inhibitor fit into this plan?

Question: Michael Schmidt - Guggenheim Securities - Analyst : So the endpoints or clinical assessment would be similar?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. Great. And then is there an opportunity to combine this with m-CALR, it's entirely different subsets of the [marker]?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. Okay. So maybe then shifting over to GVHD for a second on axatilimab, which was approved originally earlier this summer. And I know you've been waiting for the approval of the smaller vial sizes. So how are you progressing towards that? And then ultimately, the commercial launch?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And how do you expect the drug being used relative to Rezurock? Would you compete for the same patients, perhaps newly-diagnosed patients in the third-line setting, I would say, obviously, untreated patients? Or would it be -- are there -- is there opportunity to switch patients over from Rezurock? How do you think about the market dynamics? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 11, 2024 / 7:00PM, INCY.OQ - Incyte Corp at Guggenheim Global Healthcare Conference

Question: Michael Schmidt - Guggenheim Securities - Analyst : Yes. Great. And then perhaps switching to your inflammatory and autoimmune disease pipeline or portfolio starting with Opzelura, again, commercial drug. So the next thing that's going to happen here is probably the pediatric AD approval, right, in 2025. How much could that meaningfully change the commercial trajectory of Opzelura, you think?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. Great. And then I know you have data coming up also for Opzelura in prurigo nodularis in 2020 -- in the first half of '23, actually. And so yes, can you just talk about that commercial opportunity perhaps relative to AD or vitiligo or the drugs approved already? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 11, 2024 / 7:00PM, INCY.OQ - Incyte Corp at Guggenheim Global Healthcare Conference

Question: Michael Schmidt - Guggenheim Securities - Analyst : What duration of therapy would one expect in PN relative to AD and vitiligo?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. Great. So then maybe switching over to povorcitinib, oral JAK1 inhibitor, where we also expect a Phase III readout early next year in hidradenitis suppurativa which is obviously a rapidly evolving space. There's been recent approvals of Cosentyx and other agents advancing. And so beyond top line success in Phase III, I guess is there -- how do you think about the competitive dynamics in the space and where povorcitinib could fit in dependent on the Phase III data?

Question: Michael Schmidt - Guggenheim Securities - Analyst : And so on the black box topic, obviously, there's a class warning on oral JAKs. Do you expect there to be any kind of pushback or caution by patients based on the experience of oral JAK inhibitors right now? And how is the risk benefit profile perhaps in HS relative to other indications where JAKs are approved?

Question: Michael Schmidt - Guggenheim Securities - Analyst : And then one question that comes up that RINVOQ obviously also doing a study in HS. It has a much more established market presence in other areas. Sort of how do you feel povo is competitively positioned to RINVOQ?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. Okay. Superb. And then there are obviously other opportunities for povorcitinib, including PN, we just talked about it, where rapid itch resolution is perhaps an important factor. And we've seen some Phase II data already for povorcitinib there. But yes, how are you tracking towards launching that study?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. And then you've said you're also looking at CSU and asthma for povorcitinib, just maybe talk about sort of the two respective Phase II studies and what are you hoping to demonstrate.

Question: Michael Schmidt - Guggenheim Securities - Analyst : All right. Looking forward to that. And then just on vitiligo, where we talked about Opzelura, how important the duration aspect is long-term use of the topical. But you also have obviously povorcitinib and then, I believe, an IL-15 receptor beta biologic in development. Can you just talk about how you envision your sort of vitiligo portfolio to play out long term in terms of different mechanisms that you're developing.

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. Superb. And then shifting over to the two Escient assets, EP262 first. Yes, could you just discuss MRGPRX2 as a target in mast

Question: Michael Schmidt - Guggenheim Securities - Analyst : And so again, is the idea to have superior safety to perhaps relative to BTK or KIT? Or is there opportunity to improve efficacy as well?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. Understood. And then can you help set some expectations for the Phase II data in CSU that you'll report next year? And how many patients on the data set, I know, I think you tested two doses is initially, you added two doses in addition that. So just talk about the Phase II? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 11, 2024 / 7:00PM, INCY.OQ - Incyte Corp at Guggenheim Global Healthcare Conference

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. And when we look at the data, I guess, what is the right bar or the right comp for 6 weeks activity presumably. Are there other drugs that we could compare that against?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. And there are some other oral agents being developed, including a direct agonist, Evommune asset and then a negative allosteric modulator from [Zeterna]. How much visibility do you have potentially into how differentiating new drug is versus theirs? Or is it just impossible to say at this point?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. And then how do you think about other potential opportunities for this class of drugs, including atopic derma asthma, and do you have plans to expand development into those areas? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 11, 2024 / 7:00PM, INCY.OQ - Incyte Corp at Guggenheim Global Healthcare Conference

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. Makes sense. And then can you talk about the opportunity for EP547? And what are some of the areas where this could be potentially focused on?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. Great. So maybe then in the last 10 minutes or so shifting over to oncology, starting with tafasitamab. I know it's not been talked a lot about. But I'm just curious to understand the commercial opportunity in relapsed and refractory follicular lymphoma, perhaps relative to the currently marketed indication. Based on the positive MINT trial results?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And then I think you may have guided to reporting Phase III data of Tafa in first-line DLBCL next year as well, right? So which is an indication that has been notoriously difficult for others to beat our job. And so how confident are you in that study design?

Question: Michael Schmidt - Guggenheim Securities - Analyst : But not -- presumably not included in your $800 million.

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. Okay. And then just on your CDK2 program. Obviously, we saw some super interesting data at ESMO, especially in ovarian cancer. And so yes, I think the best data was at the lowest dose, the 50 milligram, if I'm not mistake.

Question: Michael Schmidt - Guggenheim Securities - Analyst : Yes. Can you just remind us how you're tracking towards RP2D identification and then initiating some of the trials that you talked about? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 11, 2024 / 7:00PM, INCY.OQ - Incyte Corp at Guggenheim Global Healthcare Conference

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And I think of the studies you talked about, the platinum-resistant ovarian cancer and then first-line maintenance, which is obviously a significant opportunity. What gives you confidence in ultimately being successful in the maintenance application which is probably the biggest opportunity.

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And then others have, looked at breast cancer for CDK2 inhibitors? Just talk about, in general, how you're planning to prioritize other opportunities for your CDK2?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And then so what are the next disclosures from the program that investors should look forward to?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. Okay. Great. Question on retifanlimab PD-1. And so I think for -- we talked about the squamous cell anal cancer opportunity just now. But in non-small cell lung cancer, I think you reported a positive study but it's unclear to me sort of what next steps are. So can you talk about if there's anything else for retifanlimab as investors think about some of the opportunities there?

Question: Michael Schmidt - Guggenheim Securities - Analyst : And then as investors think about the oncology pipeline longer term, what are other programs that you're actively investing in and where we could actually see some data at some point?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And then so earlier today, we talked about the historic fast follow approach that Incyte had in terms of pipeline development. And so yes, how would you describe your approach today? And what are other areas of focus for Incyte as you expand the pipeline going forward?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Great. All right. well, Pablo, with this, I think it's time to wrap up. So I really appreciate the deeper dive into the pipeline. And Christiana, thanks for being here as well.