Q4 2025 Incyte Corp Earnings Call

February 10, 2026

Operator: Greetings and welcome to the Incyte fourth quarter and year-end 2025 financial results conference call and webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one on your telephone keypad, and we ask that you please limit yourselves to one question, then return to the queue. As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star zero. It's now my pleasure to turn the call over to your host, Alexis Smith, Vice President, Investor Relations. Please go ahead.

Speaker #2: As a recorded. If anyone should require operator *0. It's now my pleasure to turn the call over to your host, Alexis Smith, Vice President, Investor Relations.

Speaker #2: Please go

Alexis Smith: Thank you. Good morning and welcome to Incyte's fourth quarter and full-year 2025 earnings conference call. Before we begin, I encourage everyone to go to the investor section of our website to find the press release, related financial tables, and slides that follow today's discussion. On today's call, I'm joined by Bill, Pablo, and Tom, who will deliver our prepared remarks. Steven, Dave, Mateo, and Mohamed will also be available for the Q&A portion of today's call. I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. I will now hand the call over to Bill.

Q4 2025 Incyte Corp Earnings Call

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Q4 2025 Incyte Corp Earnings Call

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Tuesday, February 10th, 2026 at 1:00 PM

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William Meury: Alexis, thank you, and good morning, everyone. I'll cover two topics today. First, I'll give you an overview of our performance in 2025, then I'll turn to our outlook for 2026 and beyond and the steps we're taking with our core business and pipeline to transition Incyte. As I touched on at JPM, there are several achievements in 2025 that stand out. First, our business exceeded expectations on three levels: total sales, Jakafi sales, and our core business sales ex-Jakafi. Second, we fundamentally changed the shape and maturity of our pipeline. We moved multiple assets from early to late-stage development. We now have several outlier opportunities for the treatment of MPNs, pancreatic cancer, colorectal cancer, and HS that have the potential to drive revenue, earnings, and cash flow into the next decade.

William Meury: Finally, regulatory applications for Jakafi XR, Opzelura for moderate AD, and povorcitinib for HS in Europe were submitted on a timely basis. The point here is we have much greater visibility into the potential growth profile of the company now than we did at the start of 2025. Everything we accomplished this past year commercially, scientifically, and operationally has created the foundation for an inflection point in 2026 and beyond. Now I'll speak to our performance in 2025 and the outlook for 2026. Turning to revenue, the business performed exceptionally well this past year. Revenues in the fourth quarter totaled $1.51 billion, up 28% versus the prior year. For full-year 2025, revenue totaled $5.14 billion, up 21% year over year. This was driven by strong commercial performance and an increase in milestone and contract revenue.

Bill Meury: Finally, regulatory applications for Jakafi XR, Opzelura for moderate AD, and povorcitinib for HS in Europe were submitted on a timely basis. The point here is we have much greater visibility into the potential growth profile of the company now than we did at the start of 2025. Everything we accomplished this past year commercially, scientifically, and operationally has created the foundation for an inflection point in 2026 and beyond. Now I'll speak to our performance in 2025 and the outlook for 2026. Turning to revenue, the business performed exceptionally well this past year. Revenues in the fourth quarter totaled $1.51 billion, up 28% versus the prior year. For full-year 2025, revenue totaled $5.14 billion, up 21% year over year. This was driven by strong commercial performance and an increase in milestone and contract revenue.

William Meury: Net sales in the fourth quarter totaled $1.22 billion, representing a 20% increase versus the prior year. For full-year 2025, net sales were $4.35 billion, also up 20% year over year, exceeding both expectations and our guidance. Growth was broad-based with nearly every product contributing meaningfully. Focusing on our core business ex-Jakafi, sales totaled $1.26 billion, representing over $400 million in growth and a 53% increase versus 2024. Opzelura, Niktimvo, and Monjuvi were the largest absolute growth contributors. This core business is expected to grow over 30% in 2026 and has the potential to grow at a 15% to 20% five-year CAGR and approach $3 to $4 billion by 2030. Now, a few comments about the key products: Jakafi, Opzelura, and our hematology and oncology products. Starting with Jakafi on slide 9, fourth quarter and full-year sales exceeded expectations.

Bill Meury: Net sales in the fourth quarter totaled $1.22 billion, representing a 20% increase versus the prior year. For full-year 2025, net sales were $4.35 billion, also up 20% year over year, exceeding both expectations and our guidance. Growth was broad-based with nearly every product contributing meaningfully. Focusing on our core business ex-Jakafi, sales totaled $1.26 billion, representing over $400 million in growth and a 53% increase versus 2024. Opzelura, Niktimvo, and Monjuvi were the largest absolute growth contributors. This core business is expected to grow over 30% in 2026 and has the potential to grow at a 15% to 20% five-year CAGR and approach $3 to $4 billion by 2030. Now, a few comments about the key products: Jakafi, Opzelura, and our hematology and oncology products. Starting with Jakafi on slide 9, fourth quarter and full-year sales exceeded expectations.

William Meury: In the fourth quarter, sales were $828 million, an increase of 7% versus prior year. Full-year sales totaled $3.093 billion, representing an 11% increase year over year. Jakafi remains an integral part of our business, and keeping it healthy is a priority. It continues to serve as a funding source for our pipeline and for future product launches. A few comments on the fundamentals of this business. First, prescriptions increased 11% in the fourth quarter and 9% for the full year 2025 despite a growing base and competition. Second, demand was up across all three indications. PV will be the largest and fastest growing indication in 2026. And with a penetration rate of only 30% versus 60 to 70% in frontline MF, it should be a reliable and significant source of growth going forward. And finally, formulary coverage for Jakafi remains excellent with near-complete coverage across plans.

Bill Meury: In the fourth quarter, sales were $828 million, an increase of 7% versus prior year. Full-year sales totaled $3.093 billion, representing an 11% increase year over year. Jakafi remains an integral part of our business, and keeping it healthy is a priority. It continues to serve as a funding source for our pipeline and for future product launches. A few comments on the fundamentals of this business. First, prescriptions increased 11% in the fourth quarter and 9% for the full year 2025 despite a growing base and competition. Second, demand was up across all three indications. PV will be the largest and fastest growing indication in 2026. And with a penetration rate of only 30% versus 60 to 70% in frontline MF, it should be a reliable and significant source of growth going forward. And finally, formulary coverage for Jakafi remains excellent with near-complete coverage across plans.

William Meury: The pediatric launch for Opzelura for atopic dermatitis is off to a strong start in the United States, with sales already annualizing around $30 million. Both dermatologists and parents are increasingly seeking nonsteroidal options for atopic dermatitis driven by concerns about long-term steroid use. International sales for Opzelura in vitiligo doubled to $130 million in 2025. In 2026, we expect sales of $750 to $790 million, representing roughly a 15% increase at the midpoint. This estimate is based primarily on continued double-digit volume growth in the United States for atopic dermatitis in vitiligo, partially offset by price actions to expand formulary coverage, as well as sustained double-digit growth internationally off of a larger base as we lap the strong full-year launch for vitiligo in Europe. Most of the benefits of the moderate atopic dermatitis launch in Europe in the second half of this year are expected in 2027 and beyond.

Bill Meury: The pediatric launch for Opzelura for atopic dermatitis is off to a strong start in the United States, with sales already annualizing around $30 million. Both dermatologists and parents are increasingly seeking nonsteroidal options for atopic dermatitis driven by concerns about long-term steroid use. International sales for Opzelura in vitiligo doubled to $130 million in 2025. In 2026, we expect sales of $750 to $790 million, representing roughly a 15% increase at the midpoint. This estimate is based primarily on continued double-digit volume growth in the United States for atopic dermatitis in vitiligo, partially offset by price actions to expand formulary coverage, as well as sustained double-digit growth internationally off of a larger base as we lap the strong full-year launch for vitiligo in Europe. Most of the benefits of the moderate atopic dermatitis launch in Europe in the second half of this year are expected in 2027 and beyond.

William Meury: As I've said, our aim long-term is to nearly double the size of this business. The nonsteroidal segment of the AD market is growing 20% year-over-year, creating a significant tailwind as prescribing migrates from topical steroids to nonsteroidal options. We still have a modest share of each of those segments, so there is substantial headroom for growth. In addition to this, our international business and new indications will serve as meaningful catalysts for the next phase of expansion. And now on slide 11, we'll turn to our hematology and oncology products. Net product sales in the fourth quarter were $187 million, up 121% compared to prior year. Full-year 2025 sales were $583 million, representing an 83% increase compared to 2024 driven by Niktimvo, Monjuvi, and Zynyz. Niktimvo finished its first year at $152 million.

Bill Meury: As I've said, our aim long-term is to nearly double the size of this business. The nonsteroidal segment of the AD market is growing 20% year-over-year, creating a significant tailwind as prescribing migrates from topical steroids to nonsteroidal options. We still have a modest share of each of those segments, so there is substantial headroom for growth. In addition to this, our international business and new indications will serve as meaningful catalysts for the next phase of expansion. And now on slide 11, we'll turn to our hematology and oncology products. Net product sales in the fourth quarter were $187 million, up 121% compared to prior year. Full-year 2025 sales were $583 million, representing an 83% increase compared to 2024 driven by Niktimvo, Monjuvi, and Zynyz. Niktimvo finished its first year at $152 million.

William Meury: We achieved broad penetration and deep utilization of BMT centers, and we've reached more than 1,400 patients with 13,000 infusions. In line with expectations, Niktimvo is being used widely in the fourth-line setting with increasing preference in the third line. As it relates to Monjuvi, sales were up 20% versus prior year based on a strong launch in follicular lymphoma in the middle of 2025. As you know, we released data in January in frontline DLBCL, where Monjuvi plus lenalidomide showed a 25% improvement in PFS, improving on R-CHOP chemotherapy, which is a regimen that still accounts for 50% of the first-line DLBCL market. This year, we plan to present the data at an upcoming medical meeting, work to incorporate Monjuvi into appropriate guidelines, and submit an sBLA in the first half with a potential FDA approval by early 2027.

Bill Meury: We achieved broad penetration and deep utilization of BMT centers, and we've reached more than 1,400 patients with 13,000 infusions. In line with expectations, Niktimvo is being used widely in the fourth-line setting with increasing preference in the third line. As it relates to Monjuvi, sales were up 20% versus prior year based on a strong launch in follicular lymphoma in the middle of 2025. As you know, we released data in January in frontline DLBCL, where Monjuvi plus lenalidomide showed a 25% improvement in PFS, improving on R-CHOP chemotherapy, which is a regimen that still accounts for 50% of the first-line DLBCL market. This year, we plan to present the data at an upcoming medical meeting, work to incorporate Monjuvi into appropriate guidelines, and submit an sBLA in the first half with a potential FDA approval by early 2027.

William Meury: Looking ahead, we've set our full-year guidance for the hematology and oncology business at $800 to $880 million for the year, representing approximately a 40% to 50% increase compared to our performance in 2025. Now, three takeaways about 2026 that I'd like to reinforce before turning over the call to Pablo. First, our core business excluding Jakafi has the potential to be as large as Jakafi is today by 2030. A key part of that growth will come from product launches we expect late this year and early 2027. I mentioned XR, Opzelura, and Monjuvi earlier, so I want to make a few comments about where we are with povorcitinib. The NDA for povorcitinib and HS has been submitted, and we anticipate filing acceptance this quarter. As you know, HS is the first of potentially three indications, the others being PN and vitiligo.

Bill Meury: Looking ahead, we've set our full-year guidance for the hematology and oncology business at $800 to $880 million for the year, representing approximately a 40% to 50% increase compared to our performance in 2025. Now, three takeaways about 2026 that I'd like to reinforce before turning over the call to Pablo. First, our core business excluding Jakafi has the potential to be as large as Jakafi is today by 2030. A key part of that growth will come from product launches we expect late this year and early 2027. I mentioned XR, Opzelura, and Monjuvi earlier, so I want to make a few comments about where we are with povorcitinib. The NDA for povorcitinib and HS has been submitted, and we anticipate filing acceptance this quarter. As you know, HS is the first of potentially three indications, the others being PN and vitiligo.

William Meury: POVA has the potential to be the first FDA-approved oral treatment for HS. Here, we have an opportunity to capture patients at two critical inflection points. First, in the prebiologic setting, a population with no FDA-approved treatments today. These patients are cycling through antibiotics and steroids that don't address the underlying disease biology. Second, in the postbiologic setting, where IL-17s and TNFs are used but where partial responses are common. An effective oral option could be transformative in both treatment settings. We'll talk more about launch plans in future calls. Second, our pipeline has the breadth and depth to support top-tier growth and the potential to 2- to 3x our top line over time. In 2026 alone, we will have 14 pivotal trials underway across seven assets by the end of the year, and multiple data catalysts.

Bill Meury: POVA has the potential to be the first FDA-approved oral treatment for HS. Here, we have an opportunity to capture patients at two critical inflection points. First, in the prebiologic setting, a population with no FDA-approved treatments today. These patients are cycling through antibiotics and steroids that don't address the underlying disease biology. Second, in the postbiologic setting, where IL-17s and TNFs are used but where partial responses are common. An effective oral option could be transformative in both treatment settings. We'll talk more about launch plans in future calls. Second, our pipeline has the breadth and depth to support top-tier growth and the potential to 2- to 3x our top line over time. In 2026 alone, we will have 14 pivotal trials underway across seven assets by the end of the year, and multiple data catalysts.

Pablo Cagnoni: Thank you, Bill, and good morning, everyone. As Bill mentioned earlier, in 2025, the pipeline reached a new level of breadth and maturity, setting up a materially different outlook for the company going forward. First, our approved portfolio and regulatory footprint broadened with approvals for Monjuvi in follicular lymphoma, Zynyz in squamous cell anal carcinoma, and Opzelura in pediatric atopic dermatitis, alongside regulatory submissions for Jakafi XR, Opzelura, and povorcitinib. Second, positive clinical data meaningfully advanced multiple programs, including phase 3 registrational data for povorcitinib in hidradenitis suppurativa or HS, and early-stage results supporting pivotal development for the mutant CALR program in MF and ET, KRAS G12D in pancreatic cancer, and TGF beta receptor 2 x PD-1 bispecific in MSS colorectal cancer. In 2026, we will continue to build on this momentum through additional approvals, regulatory filings, pivotal data readouts, and trial initiations.

Pablo Cagnoni: Our hematology portfolio balances two priorities: expanding the addressable market of established products such as tafasitamab across the full spectrum of B-cell lymphomas and axatilimab in Graft-versus-Host Disease, and advancing novel therapies in myeloproliferative neoplasms via our MPN portfolio of targeted therapies. In GVHD, we're advancing Niktimvo in two first-line studies, evaluating it in combination with ruxolitinib as well as in combination with steroids. Data from these trials are expected in early 2027 and early 2028, respectively. Our MPN pipeline remains a key area of focus where we're advancing three targeted therapies: 989, our mutant CALR monoclonal antibody, 784, our mutant CALR x CD3 bispecific antibody, and 058, our JAK2 V617F small molecule inhibitor. Each of these programs is designed to address a well-defined disease driver with the potential for disease-modifying activity and the opportunity to fundamentally change how MPNs are treated.

Pablo Cagnoni: Looking ahead to upcoming milestones, we expect to report phase 1 data for 058 in the second half of this year and phase 1 data for 784 in 2027. With that context, I would like to turn to slide 17 to review our progress with 989 and the breadth of development efforts for this program. As a reminder, last year, we presented phase 1 data evaluating 989 in CALR-positive patients with essential thrombocythemia, and myelofibrosis. The data presented at EHA and ASH in 2025 reinforced the potential of our approach to directly target the oncogenic driver mutation, addressing both the underlying disease and key clinical manifestations. Importantly, these proof of concept results provide a strong foundation to advance 989 into pivotal phase 3 development. We expect to initiate our phase 3 trial evaluating 989 in second-line CALR-positive ET patients in mid-2026, following regulatory alignment in Q1.

Pablo Cagnoni: In December, tafasitamab was approved in both Europe and Japan in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma, following at least one prior line of systemic therapy, further expanding its global footprint. In January, we reported positive top-line results from the pivotal phase 3 frontline trial, which evaluated tafasitamab and lenalidomide in combination with R-CHOP as a first-line treatment for newly diagnosed high-grade DLBCL with IPI of 3-5. The study met its primary endpoint of progression-free survival and achieved its key secondary endpoint of event-free survival by investigator assessment with no new safety signals observed. We plan to present additional data from the frontline study, including overall survival and subgroup analyses, at an upcoming medical congress this year. Based on these results, the sBLA for first-line DLBCL remains on track for submission in the first half of 2026.

Pablo Cagnoni: If approved, Monjuvi has the potential to address the full spectrum of B-cell lymphomas. Turning now to oncology. Our oncology portfolio focuses on advancing novel therapies that target well-validated but historically difficult pathways in high-incidence cancers, including colorectal, pancreatic, and ovarian cancer. Starting with 890, our first-in-class TGFβR2 x PD-1 bispecific antibody. Based on data we present at ESMO and following alignment with the FDA, we initiated a phase 3 study in December evaluating 890 in combination with FOLFOX and bevacizumab compared to placebo in combination with FOLFOX, bevacizumab in first-line MSS colorectal cancer patients. Next, 667, our CDK2 inhibitor, has been evaluated in patients with platinum-resistant ovarian cancer with cyclin E1 overexpression, a biomarker-defined population with significant medical need.

Pablo Cagnoni: In combination with standard of care therapies, 734 demonstrated a manageable tolerability profile when combined with gemcitabine plus nab-paclitaxel and modified FOLFIRINOX without compromising chemotherapy dose intensity. Taken together, these data support the potential for 734 to be meaningfully integrated into frontline treatment for patients with PDAC. Earlier this year, we gained alignment with the FDA on the registrational program and are on track to initiate our phase 3 trial in first-line PDAC in Q1 2026. If approved, 734 would represent the first G12D targeted therapy for the treatment of patients with pancreatic cancer. With pivotal trials now underway for CDK2, TGFβR2 x PD-1, and KRAS G12D, our strategic focus is turning to how we can expand these programs across additional tumor types and clinical settings. Our objective is to broaden the potential impact of these programs and reach more patients over time.

Pablo Cagnoni: We expect to provide updates during 2026. Finally, in IAI, we have a JAK anchor franchise with topical to oral solutions across mild to severe immune-mediated dermatological conditions. First, an update with Opzelura. In early 2025, we shared results from the phase 3 program in Prurigo Nodularis, where Opzelura met its primary endpoint, demonstrating statistically significant improvement in itch compared to placebo in one of two registrational studies. In January, we received FDA feedback indicating that an additional clinical efficacy study would be required to support registration for this indication. As a result, we have decided to pause further development of Opzelura MPM at this time. Opzelura has also been evaluated in a large phase 3 registrational program as a topical treatment for mild to moderate Hidradenitis Suppurativa, with results expected from the 2HS1 and 2HS2 trials later this year.

Pablo Cagnoni: Hidradenitis Suppurativa is also the most advanced indication for povorcitinib, our novel JAK1 small molecule inhibitor. Earlier this year, we presented 24-week phase 3 data that further reinforced the differentiated clinical profile of povorcitinib, demonstrating deep and sustained improvements across multiple key endpoints. Importantly, povorcitinib also showed a rapid and robust reduction in skin pain and draining tunnels, a defining symptom for patients and a critical treatment goal for clinicians. From a regulatory standpoint, we submitted the MAA to the EMA during Q4 2025 and anticipate acceptance of the NDA filing by the FDA in Q1 2026. Beyond HS, our phase 3 registrational trials in vitiligo and PN continue to progress well. In vitiligo, we anticipate data from our two registrational phase 3 trials, STOPV1 and STOPV2, in mid-2026. In PN, we anticipate data from our STOPPN1 and STOPPN2 studies, expected by year-end.

Pablo Cagnoni: Finally, we continue to explore its broader potential with phase 2 proof of concept data in asthma anticipated in the second half of 2026. Overall, 2026 is a pivotal year for Opzelura and povorcitinib, with important key regulatory and clinical milestones across all evaluated indications. To close, we have a catalyst-rich year ahead with multiple late-stage data readouts, regulatory milestones, and pivotal trial initiations across our three core franchises, underscoring the breadth, depth, and maturity of our pipeline. We look forward to an exciting year of execution and to providing continued visibility as these milestones unfold. With that, I'll turn the call over to Tom for a financial update on the quarter. Thanks, Pablo. As Bill mentioned earlier, our total revenues and product revenues for the quarter were $1.51 billion and $1.22 billion, respectively, increasing 28% and 20% from the prior year.

Pablo Cagnoni: Ongoing operating expenses for the full year 2025 increased 11% year over year compared to a 19% increase in ongoing revenues during the same period, leading to a continued increase in operating leverage and margins. I'll now turn the call back over to Bill. Thanks, Tom. Before we close, I want to reiterate our revenue guidance and address our expense outlook for 2026. As mentioned earlier, we have set full year 2026 revenue guidance of $4.77 to 4.94 billion, representing a 10% to 13% increase from prior year. This includes net revenue expectations for Jakafi of $3.22 to 3.27 billion, Opzelura of $750 to 790 million, and Hematology/Oncology of $800 to 880 million. Sales for our core business ex-Jakafi will range between $1.57 and 1.69 billion, representing roughly a 30% growth rate at the midpoint in 2026.

Pablo Cagnoni: As it relates to expenses, I think we've achieved the right balance between maintaining financial discipline and ensuring we are not underfunding strategic initiatives or compromising our growth prospects. We will continue to get leverage out of this business where we can so that we can create financial breathing room to invest where it matters most. Ultimately, what we're solving for is the steepest possible growth curve post 2029 and durable earnings and cash flow. We expect total GAAP R&D and SG&A operating expenses to be $3.495 billion to $3.675 billion in 2026. At the midpoint, this represents a 4% increase versus prior year, driven primarily by targeted investments in our late-stage pipeline and launch readiness while maintaining tight control elsewhere. We expect R&D to be up roughly 10% from last year, consistent with advancing programs that we believe can meaningfully shape the company's future.

Bill Meury: As it relates to expenses, I think we've achieved the right balance between maintaining financial discipline and ensuring we are not underfunding strategic initiatives or compromising our growth prospects. We will continue to get leverage out of this business where we can so that we can create financial breathing room to invest where it matters most. Ultimately, what we're solving for is the steepest possible growth curve post 2029 and durable earnings and cash flow. We expect total GAAP R&D and SG&A operating expenses to be $3.495 billion to $3.675 billion in 2026. At the midpoint, this represents a 4% increase versus prior year, driven primarily by targeted investments in our late-stage pipeline and launch readiness while maintaining tight control elsewhere. We expect R&D to be up roughly 10% from last year, consistent with advancing programs that we believe can meaningfully shape the company's future.

Pablo Cagnoni: 80% of our investment in R&D is concentrated in the seven programs Pablo reviewed earlier. As it relates to SG&A, G&A will be down 10% compared to last year, while sales and marketing are modestly higher to support the key launches in the second half of the year. Together, SG&A will remain relatively flat year over year, reflecting deliberate reallocation rather than broad-based spending. Finally, we anticipate cost of goods to remain relatively stable in the 8% to 9% range of net sales. We have an excellent set of opportunities in front of us and a path to replace Jakafi. What matters most right now, like at any company, is execution, getting things done, which means orchestrating product launches, running multiple phase 3 trials to tight timelines, and managing the business at a detailed level. With that, I'll turn the call over to the operator for Q&A. Thank you.

Bill Meury: 80% of our investment in R&D is concentrated in the seven programs Pablo reviewed earlier. As it relates to SG&A, G&A will be down 10% compared to last year, while sales and marketing are modestly higher to support the key launches in the second half of the year. Together, SG&A will remain relatively flat year over year, reflecting deliberate reallocation rather than broad-based spending. Finally, we anticipate cost of goods to remain relatively stable in the 8% to 9% range of net sales. We have an excellent set of opportunities in front of us and a path to replace Jakafi. What matters most right now, like at any company, is execution, getting things done, which means orchestrating product launches, running multiple phase 3 trials to tight timelines, and managing the business at a detailed level. With that, I'll turn the call over to the operator for Q&A. Thank you.

Pablo Cagnoni: Maybe to start with Pablo, for the CALR pivotal programs, just your latest thoughts as you've gotten into designing the phase 3s as to just kind of how to address the potential differences for 989 and dosing for some of the different CALR mutations to ensure full potency. Is the best approach to start low, titrate up for those that need it, or maybe prospectively kind of route people to different starting doses, or is it just simplify things and max out dose for everyone? And then maybe just a quick clarifying thing on the commentary around Opzelura pricing. Just how much of that was driven by your entry into new markets and needing to access those versus maybe some of the competitive launches putting pressure on the existing indications? Yeah. Go ahead. Go ahead, Pablo. Take the first one. Thanks for the questions, Marc. Okay. Good morning, Marc.

Hey, thanks for taking the question in Congress, on progress. Um, maybe to start with Pablo for the kalhar pivotal programs, just your latest thoughts, as you've gotten into designing, the phase 3. That's to just kind of how to address the potential, um, differences for 989 and dosing for some of the different kalhar mutations to, you know, to ensure full potency. You know, that's approach to start low titrate up, um, for those that need it or maybe, you know, prospectively kind of wrap people to different starting, doses or or is it just, you know, simplify things, and max out those for everyone and then maybe just a quick clarifying thing on the commentary around opler pricing. Just how much of that was driven by, um, the entry into your entry into new markets and needing to access those versus, um, maybe some of the competitive launches putting pressure on the the existing indications.

Pablo Cagnoni: We're also going to discuss the primary endpoint of the study, which obviously will be some version of hematologic response, but the question there is the timing for the evaluation of the primary endpoint, which we would like to discuss with the agency. So all in all, I think we're in a good position. I think we submitted a good package. We look forward to interacting with the agency, and we'll provide an update later this year. Yeah. Thanks, Pablo. And Mark, as it relates to Opzelura, not a competitive issue. We take a very long-term view of Opzelura. We have exclusivity to the end of the next decade. We just launched a pediatric indication. We potentially could have an HS indication. The market is really moving, as you know, as I mentioned, prescribing migrates from steroidal topicals to non-steroidal topicals.

Pablo Cagnoni: This was about improving formulary coverage for the long term at the major PBMs so that it's a frictionless experience for dermatologists and patients. And I would expect the impact on ASP in 2026 to roll off in 2027 and beyond will be providing fewer discounts in the future than we did in the past. That's it. Thanks for the question. Thank you. Next question is coming from Tazeen Ahmad from Bank of America. Your line is now live. Hi, guys. Good morning. Thanks for taking my question. Also one on Opzelura. So can you just give us your sense of what the uptake is and the current approved indications and the average number of tubes that are being used? We understand the importance of being on formulary, but we'd also like to get a better sense of how to better model sales on a go-forward basis. Thanks. Yeah.

Pablo Cagnoni: I guess on the trial, with the IPI eligibility criteria, it seems like the trial would maybe have a higher enrichment of patients with a poorer prognosis. So I guess in this context, how should we think about the PFS benefit that you reported, and are there any implications here for Monjuvi's potential use across a broader front-line population? Thank you. Great questions. I'll have Pablo answer the second question, and then we'll double back and answer the first questions. Thanks, Pablo. So you're correct. This study was focused on patients on IPI 3 to 5, and that is a group with the worst prognosis than what has been reported by some of our competitors in the front-line DLBCL setting. I also would encourage you what we note today, obviously, as mentioned in the script, that about half the patients are still getting R-CHOP.

Uh, so you're correct. Uh, the study was focused on patients and IPI, 3 to 5, uh, and that is a group with the worst prognosis that what has been reported by some of our competitors in the Frontline dlbcl setting. Uh, I also would encourage you, uh, what we know today. Uh, obviously, as mentioned in the script that about half, the patients are still getting our chop. Um, and the recently introduced competitors in this space, do not address the need of all patients with dlbcl. As you know there's an entire subset of patients here with uh GCB. Uh, dlbcl that are not currently addressed by uh, 1 of the more recent entries, uh, in the in this space, we look forward to showing the full benefit of mubi in this patient population. Uh, we think that the benefit in PFS that we reported is very competitive, um, as you know, the safety profile of mubi is very well established in this context. So we'll discuss the results in more detail over the course of the year. Um, but we're very encouraged by what

Pablo Cagnoni: Right now, we're going to have, by the end of 2026, early 2027, a three-indication product. We'll finish this year somewhere in the range of the mid-$200 million. With an indication of front-line DLBCL, and I don't see it as a fight to the death between Polivy and Monjuvi, we have a very positive study in front-line DLBCL, clear separation in terms of PFS. It's simply an intensification strategy with Monjuvi being added to LEN and R-CHOP versus a substitution or a replacement strategy with Polivy. And so there's incremental revenue associated with Monjuvi that will support building this core business in 2030 to $3 to $4 billion. Mohamed, do you have anything to add? Yeah. Thanks, Rosie, for the question. First-line DLBCL represents the largest potential opportunity for Monjuvi with approximately 30,000 patients treated annually.

Pablo Cagnoni: 50% of those patients, as was mentioned, are still being treated with R-CHOP today. As Bill just described, Monjuvi is an addition to R-CHOP versus replacing R-CHOP. As Pablo mentioned, full spectrum of efficacy across all different types of patients with the PFS benefit that's been communicated, I think, positions Monjuvi not just for short-term growth but continues to make Monjuvi a meaningful contributor, as you heard from Bill and others, around our growth story in 2029 and beyond. Thanks for the question, Rosemary. Thank you. Next question today is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live. Thanks for taking my question. Maybe I'll ask about 890, your bispecific for colorectal cancer. Are we going to see any additional phase 1, 2 data in 2026, and does the pivotal study have an interim analysis? Thanks. Thanks, Eric.

Pablo Cagnoni: Pablo, you want to work with Steven, and you want to take that? Yes, Eric. Good morning. So yes, you will see additional data over the course of the year. That program, as I mentioned in my prepared remarks, was initiated. The phase 3 study was initiated already. We're in the process of expanding the footprint. We have identified more than 200 sites globally to execute this study, and we look forward to sharing updated data both in combination with FOLFIRINOX + bevacizumab as well as other combinations that we are implementing for that program. So you'll see more data over the course of the year. We'll give more clarity in the specific timing of those as the year progresses, depending on submissions to different conferences. Thanks, Eric. Thank you. Next question today is coming from Salim Syed from Mizuho Securities. Your line is now live. Hi.

Pablo Cagnoni: This is Eric Lavington on for Salim. Thanks for taking our question. I was just wondering if we could get a little bit more color on the Opzelura in PN and why the FDA was asking for another phase 3 or recommending it, if that has any read-through to the Opzelura in HS or if it, per chance, might have to do with trial designs for HS, PN. Thanks. Great. Thanks for the question. Steven Stein will answer that for you. Eric, thank you. You asked a few questions related to both PN and HS. So just in Pablo's prepared remarks, if you remember, we conducted two large phase 3s in prurigo nodularis. The one study was positive and statistically significant. The second study just missed. Based on comments during the year that the FDA made, we approached them if their combined analysis could suffice to get across the finish line.

Pablo Cagnoni: While the second study did barely miss the primary endpoint, it was very positive for the Investigator Global Assessment of treatment success. So we're convinced that Opzelura has strong efficacy in patients with prurigo nodularis. As I mentioned in my prepared remarks, we paused further development there. We're discussing whether we will or will not do an additional trial to try to support that indication. I obviously agree with Steven. I don't think there's any read-through to the HS indication. Thank you for the question. Thank you. Next question is coming from Salveen Richter from Goldman Sachs. Your line is now live. Good morning. Thanks for taking my question. Could you speak to the MKLR bispecific here? You've guided to phase I data next year. Maybe tell us more about this asset and how it could be differentiated from your current MKLR program.

Unique situation where we had 2 studies 1 positive, 1 negative. And as Pablo said, that's why, you know, the program's currently paused while we debate whether or not to conduct an additional study, there is no a read through to HS in our, uh, HS studies. We do in standard, um, Regular development, uh, again 2, large phase. 3s acrew in very well. As you know, our proof of concept data is very strong there, and obviously, we want those studies to be positive and get across the Finish Line, um, and I don't think public once said anything else. No, I just I was just uh, just a small comment on PN. While the second study did barely miss the primary input of edge. It was very positive for the investigator of global assessment or treatment success. So we're convinced that OBS Sola has strong efficacy in patients with pgal nodular areas. Um as I mentioned, in my prepared remarks, we pause for the development there, we're discussing whether we do we will or will not do an additional trial to try to support that indication.

Is going well. Um, as you might remember, we designed our car by CD3 tell engager by specific, uh, purposefully, uh, with the caller arm binding to a different epitope, from our color antibody, the reason for that is. Obviously, if patients, for some reason, do not respond to the color antibody, there would be ideal targets for the bicep specific. Now, in terms of understanding where exactly we'll place the device specific in the treatment Paradigm for patients with mpns. I think it's too soon for me to elaborate too much there. Um, we believe that there might be some patients that require more potent approach or that require a molecule that produces faster responses or perhaps that after initial responses to the call or antibody, for some reason progress, as we generate the efficacy data that we will have next year. For the device specific, we will get more clarity on to working position or in the treatment Paradigm in patients with mpns.

Now, in terms of the v617f program, uh, we remain fully convinced that if you hit this driver mutation, the fee 617 mm mutation page in APN, if we hit it hard enough we will get the same type of outcomes that we saw with the color antibody and mfn. This is a driver mutation, we have a small molecule inhibitor, we have very strong preclinical package that we present a repeatedly and we believe that, if we hit it hard enough, we will get the same kind of transformative, clinical effects and molecular effects that we saw with 9989, we just need to generate that data. We are now entering the clinic with a new formulation and we discussed recently a solid dispersion formulation we will have data later this year. And once we have that data, we'll tell you what the next steps of the program are. And Pablo also, the key is that with 617 F, we'll cover 3 MP in mfet, npv not just MF at ET and the mutation frequency. As you know, saline is 2 times.

Pablo Cagnoni: Then I can come back with the competitive landscape and the expansion of this program. Go ahead. Yeah, Jay, thank you for the question. So as Pablo said, in the updated ASCO GI, we had that 37% response rate. We had very encouraging data on duration of response, potentially a read-through from duration of treatment to PFS. So we're really encouraged. I think the second really important point there was the ability to combine our G12D inhibitor with both standard-of-care chemotherapy regimens in the front line, so Gemzar/Abraxane plus modified FOLFIRINOX, and the ability to deliver those regimens with the dose. So you can read through to that. Obviously, the study will go up on ClinicalTrials.gov as soon as it's open. That we intend to do a first-line study in combination with both chemotherapy regimens. We'll stratify accordingly.

I'm going to have Stephen comment on the trial design. Then I can come back with the competitive landscape and uh, expansion of this program. Go ahead. Yeah, Jay thank you for the question. So as you know, Pablo said in in the updated escogi, we had that 37% response rate was very encouraging data on duration of response, potentially a read through, from duration of treatment to PFS. So we really encourage. I think the second really important point there was the ability to combine our 12d. Inhibitor with both standard of care chemotherapy regimens in the front line. So Gemma breathing plus modified for for Inox and the ability to deliver those regimens with the dose. So you can read through to that. Obviously the study will go up on kales as soon as it's open that we intend to do a first line study in combination with both chemotherapy regimens. Will stratify accordingly. It'll probably be 50/50

Percent approximately each use and then it'll be a comparison to the chemotherapy with Standard Time to event end points. We may look at things along the way, uh, in terms of response rate, Etc. But it's a time to event study in that setting, um, in terms of other studies Beyond pedak. Obviously, this is a compound, uh, that we really like, I just alluded to the activity in pedak. We have interesting activity in other tumor types, where 12d is important like color, erectile cancer, and lung, Etc. So stay tuned to the developments there and including in Pak as well. This potential to potentially do things like adant or near adjuvant, um, studies as well, which you know will outline as soon as we're ready to do. So, so it's an important compound to us. We, um, you know, may well be the first 12d to get across the Finish Line. In terms of mutation specific therapy in a large tumor with massive unmet need and the ability to combine with both first line standards of care chemotherapy.

Pablo Cagnoni: We could be first or early in pancreatic, and we could be first and only in colorectal. And so right now, we have to execute this program and, as Pablo talked about and Steven, expand these programs. And we have the capabilities and the resources to maximize both assets. If we ever needed a partner, we would think about that carefully, expand our geographic reach, and we would do it on our terms. But we're sort of locked in on both of these. And I think competition is less important, and phase three execution is most important. Thank you. Our next question is coming from Matt Phipps from William Blair. Your line is now live. Great. This is Madeline on for Matt Phipps. Thanks for taking our question. On POVO in HS, did the pre-NDA discussions with the FDA discuss the potential to include biologic-naïve patients in the labeled indication?

Pablo Cagnoni: Thanks. Yeah. Thank you for the question. I'll let Steven Stein answer it. Yeah. So obviously, our study included both populations, prebiologic and postbiologic. In fact, about 33% to 36% of patients had biologic exposure. It showed the activity, which we updated during the year, showing extremely encouraging HiSCR response rate, that increase over time, excellent pain control, upwards of 70% of patients over time having little to no pain, and excellent data on draining tunnel. And that is included in both populations. The postbiologic activity is a little higher. We submitted the NDA, as we alluded to in our remarks, and that'll be by the end of Q1, should be signed off by the FDA. And we are seeking a label in both populations. Thanks. Thank you. Our next question today is coming from Vikram Purohit from Morgan Stanley. Your line is now live.

So uh, by by the second half of this year, we'll have a pretty substantial uh data set in patients with previously, untreated model fibrosis. And and we're randomizing patients to 989 versus a combination of 999, RX name. So we'll have a very good idea of what the efficacy is at that in that population. Now, let me make something very clear. I believe the data we have today with 99.99 that we presented at us that we have with 989 mostly in previously. Treated patients with MF a little bit of naive patients that were not allowed to report. For Jackfruit of 989 will support developing the first line setting. Um, we do need the data set that will present later this year in order to discuss with FDA, how to design and implement the phase 3 trials. But I am fully convinced that this medicine will be developable in first line MF. And we'll give you more clarity later this year.

Pablo Cagnoni: Regarding the XR, any preliminary conversations with payers on formulary access or early signs that give you confidence on the eventual launch here? Thank you. Yeah, it's a good question. We absolutely have had conversations with every major PBM. Here's how I would think about it. I think that Jakafi is the perfect product for an XR formulation because, if you think about it, it treats a chronic symptomatic disease to twice-a-day drug with a 3-hour half-life. And we know that once-a-day formulations produce an adherence gain of 15% to 25%. So there is a medical reason why this product should be put on formulary. That's point number one. Point number two is we have to set a price that makes sense for the PBMs and the health plans, for the patients, and for Incyte. And there is a price point that's going to make sense.

Pablo Cagnoni: As you remember, we signed a collaboration with Enable late last year, I believe in October of last year, to use their infusion device, which will allow very high volumes of infusion by the patients at home without the need to go to the doctor's office. It's a self-applied device. It takes about 10 to 15 minutes, and the patient does it without any major discomfort. It's not a device that patients have to work continuously. They just do it at the time of infusion, and then they can remove it and throw it away. So we believe that that device will give us the alternative to really have a very simple subcutaneous infusion experience for patients, pretty much regardless of the dose. But in terms of specifics, we need a little bit more data to fully answer the question. We'll have that data over the course of the year.

As you remember, uh, we, we signed a collaboration with, uh, with enable late. Last year, I believe in October of last year to using fuse device, um, which will allow very high volumes of infusion by the patients at home. Uh, without the need to go to the doctor's office is a self applied device, um, it takes about 1015 minutes and the patient does it without, you know, without any major discomfort is not a device that patients have to work continuously. They just do it during the time of infusion, and then they can remove it and throw it away. So we believe that that that device will give us the alternative to really have a very simple. Subcutaneous infusion experience for patients, pretty much regardless of the dose, but in terms of specifics, um, we need a little bit more data to fully answer the question. We'll have that data over the course of the year

Pablo Cagnoni: That's what the animal model data suggests, that there is a window, the ideal window of selectivity between the effect on the mutant and the V617 mutant and the wild type is around the IC35. We believe that with the current formulation, based on preclinical data, we should be able to achieve that level of exposure. That question will be answered relatively quickly over the course of this year, and we believe we'll then have clinical data in the second half of 2026. But the IC35 point is related to the selectivity of the molecule. Now, as I mentioned, I think towards the end of last year, and we reiterated at J.P. Morgan earlier this year, we do have backup programs in this space. We are fully committed to this target. We believe hitting this target hard will translate into clinical benefit in these patients.

Pablo Cagnoni: If we do those two things, povorcitinib is going to be a major driver of revenue for this company in HS. Then, of course, you layer in PN and vitiligo, and we have a very sizable product. That's how I would think about it. If you want to turn to the asthma piece. Look, we know from all the data that we've been generating over the past several years across a range of indications that povorcitinib is a very strong, very potent anti-inflammatory medicine. In that context, and knowing that asthma is an inflammatory disease, I think there's a strong rationale. There was a strong rationale when the study was started to develop povorcitinib in asthma, particularly in patients, obviously, that don't respond to inhaled corticosteroids or long-acting beta agonists, and particularly in patients with low eosinophilic asthma.

So look, I we know from all the data that we've been generating over the past several years across, a range of indications. That poverty is a very strong, very potent anti-inflammatory medicine, um, in that context and knowing that asthma is an inflammatory disease. I think this is a strong rationale. There was a strong rationale with the study was started to develop over Sydney and Asthma. Particularly in patients, obviously that don't respond to inhaled corticosteroid, to a long, acting beta Agonist and particularly in patients with lowest inhaling asthma. Now, we are conducting a well-designed randomized, phase 2 study, um, we will have the there later this year and based on that, we'll decide next steps but obviously there was a strong scientific rationale to do that and we look forward to sharing the data later this year.

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Q4 2025 Incyte Corp Earnings Call

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Q4 2025 Incyte Corp Earnings Call

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