Oct 29, 2026 earnings call — Updated full-year net sales guidance
Raised full-year net sales guidance to $5.210 billion-$5.300 billion.
Revenue $1.6B (est $1.5B) · EPS $-3.60 (est $-3.93) · Next-quarter revenue outlook $5.2B–$5.3B
Key quotes
"Jakafi had another strong quarter with growth across all indications, and sales from our core business, excluding Jakafi, increased 37% from prior year."
"we achieved important regulatory milestones, including the approval and launch of OPZELURA for moderate AD in the EU in the third quarter."
"Third, we continued to advance our late-stage pipeline, including trial initiations and expansion efforts for key programs like G12D, TGFβ×PD-1, and 989."
Analyst Q&A 17
frontline 989 and CALR data update
Q (Tazeen Ahmad · BofA): The analyst asked what key items to focus on in the upcoming frontline MF update for 989 and CALR this quarter.
A: Management said they will present an update at ASH on first-line data. They described about 55 frontline patients (about 20 ineligible for Jakafi and about 40 treatment-naive), split roughly two-thirds single agent and one-third combination, and noted the presentation data cut is about four months later than the abstract.
"At ASH, we are going to present, as promised, an update on the first-line data." — Pablo Cagnoni
definition of prior JAK inhibitor treatment
Q (Gustav · Barclays): The analyst asked how prior JAK inhibitor treatment will be defined in the second-line MF pivotal for 989, and whether patients will be defined as resistant, refractory, or intolerant, and if there is any minimum duration or dose required.
A: Management said the definition is standard: patients who do not achieve ideal SVR35 or ideal spleen or symptom responses to Jakafi, and intolerance is usually thrombocytopenia or anemia as determined by physicians. They said there is no minimum duration or dose specified in the protocol and the prior Jakafi dose before entering the second-line study is not predetermined.
"There is no minimum duration, I do not believe." — Pablo Cagnoni
OPZELURA demand and net sales
Q (Sylvia · JPMorgan): The analyst asked for more detail on the strength of OPZELURA and whether management could quantify gross-to-net this quarter and how it differed from third quarter 2025.
A: Management said they invested to expand the sales force and access earlier in the year and that key metrics—underlying prescription demand and new patient starts—have been strong for several months. Mohamed quantified U.S. net sales grew 25% on a pro forma basis and said overall demand grew 24% year-over-year, with new patient volume growing 2x the market.
"Just to reiterate, in the U.S., we grew net sales 25% on a pro forma basis, which basically accounts for the GTN benefit that you would have seen from the line extension settlement that we declared." — Mohamed Issa
axa+rux GVHD readout timing
Q (Eric · Mizuho): The analyst asked why the first-line axatilimab plus ruxolitinib GVHD readout moved from Q4 2026 to Q1 2027 and what the tradeoffs were.
A: Management said they wanted more than just the primary endpoint and prefer to show durability of response, subsequent therapy, and a comprehensive safety review at a scientific meeting. They therefore shifted the presentation to the first quarter of 2027 to present the fuller dataset.
"We want to present that in a scientific meeting, and the most appropriate one is in the first quarter of 2027." — Pablo Cagnoni
frontline 989 development requirements
Q (Brian Abrahams · RBC): The analyst asked what monotherapy or combo activity would be needed and what KOLs would expect to justify developing 989 as a frontline alternative or add-on for treatment-naive CALR patients.
A: Management said they need the more comprehensive ASH data with longer follow-up, including single agent and combination with Jakafi, plus a Type C meeting with FDA about using a composite endpoint. They will make a decision on the frontline study after those FDA conversations and the full dataset, and could run a three-arm study (Rux vs Rux+989 vs 989 alone) depending on the data and FDA input.
"So once we complete those conversations with the FDA, and once we have the full data set, we will make a decision on the frontline study." — Pablo Cagnoni
pipeline shape and near-term milestones
Q (Evan Seigerman · BMO): The analyst asked management to summarize pipeline progress over the past year and what to focus on over the next year besides lslR at ASH.
A: Management said the pipeline has matured and now includes a mix of higher-risk, higher-reward and more incremental assets. They noted specifically they have six assets in phase III and that investors should expect updates over the next 12 to 18 months including phase I updates, study initiations, and program expansion news.
"More specifically, we have six assets right now in phase III." — Bill Meury
deprioritizing PROC and MF endpoints
Q (Andrew Berens · Leerink Partners): The analyst asked why PROC for CDK2 was deprioritized and asked for color on MF endpoints and regulatory willingness to accept biomarker-driven endpoints in frontline.
A: Management said 667 showed encouraging activity but the trial would be hard to enroll and commercial prospects in platinum-resistant ovarian cancer looked limited given competing ADC data; they will continue the maintenance study and discuss data with FDA. On MF, they said a surrogate biomarker endpoint is not yet available (VAF is imperfect) and it is time to consider alternative endpoints beyond SVR35 and TSS50—like measures of normal hematopoiesis and spleen volume—and they will continue discussions with FDA.
"What we do believe, however, is that it is time in MF to consider alternative endpoints to SVR35 and TSS50." — Pablo Cagnoni
next-gen CALR antibody and bispecific role
Q (Salveen Richter · Goldman Sachs): The analyst asked what preclinical data will be shared for the next-generation CALR antibody, how to think about its profile vs 989 and competitors, and how the bispecific would be positioned.
A: Management said their next-generation CALR antibody is best-in-class based on their and competitors' preclinical data, describing it as 70 times more potent against non-Type 1 mutations with a much longer half-life and suitable for subcutaneous monthly dosing in a pen. They said bispecific positioning will depend on efficacy and safety data and might fit patients needing rapid tumor reduction, but its role could shrink if 989 data continues to improve.
"This novel medicine is 70 times more potent against non-Type 1 mutations, and it has a much longer half-life." — Pablo Cagnoni
734 plus petosemtamab combinations
Q (Jay Olson · Oppenheimer): The analyst asked about plans for combination strategies for 734 in PDAC and CRC, especially with petosemtamab, and about moving 734 earlier in treatment.
A: Management said they plan to study 734 in combination with petosemtamab and FOLFOX in colorectal cancer, starting with a phase I and aiming to move to frontline therapy as quickly as possible. They also said they chose petosemtamab because they believe it is the best next-generation EGFR inhibitor and placed the collaboration accordingly.
"The combination that we announced is in fact to study 734 in combination with petosemtamab and FOLFOX in patients with colorectal cancer." — Pablo Cagnoni
G12D enrollment and daraxonrasib impact
Q (Ash Verma · UBS): The analyst asked about enrollment strategy for the G12D program and whether post-progression daraxonrasib use could differ across arms and affect results.
A: Management said they modeled this extensively and will track post-progression daraxonrasib use during the study and can shift enrollment to countries where daraxonrasib is not approved if needed. They also said they already have more than enough U.S. patients enrolled to be sufficient for an FDA submission and will monitor use to ensure it does not differentially impact post-progression PFS2.
"I would say at this point, we already have more than enough patients enrolled in the U.S. to be sufficient for an FDA submission." — Pablo Cagnoni
JAK use limits in control arm and primary endpoint
Q (Gavin Clark-Gartner · Evercore): The analyst asked if there are limits on the percent of patients who can receive a JAK inhibitor in the best-available therapy arm, what they expect that number to be, and whether the primary endpoint is Type 1 only and how hierarchical testing will be handled.
A: Management said there is no limitation on the percent of patients who can receive a JAK inhibitor in the control arm and cautioned that washout differences affect response rates in second-line studies. They confirmed the primary endpoint is in Type 1 patients to ensure success; data in non-Type 1 patients will be collected but the primary analysis is Type 1.
"No, there is no limitation in the percentage of patients that can receive a JAK inhibitor." — Pablo Cagnoni
pan-RAS combos and G12V interest
Q (John Newman · Canaccord Genuity): The analyst asked whether Incyte has considered combinations with a pan-RAS inhibitor and whether they would consider licensing or pursuing a G12V program.
A: Management said they do not rule out a combination with a pan-RAS inhibitor and are continuing to evaluate options; they have done preclinical work that suggests value. They also said they are interested in expanding their KRAS franchise and would not rule out addressing G12V patients at some point.
"On the pan-RAS, we don't rule out doing a combination with the pan-RAS." — Pablo Cagnoni
frontline registration and next-gen timing
Q (Michael Schmidt · Guggenheim): The analyst asked whether a frontline registration strategy would focus on Type 1 patients with a long endpoint or include a broader population, and how to position next-gen vs 989.
A: Management said they will let the ASH data guide the frontline strategy and continue to develop 989 to address all CALR-mutated patients; a three-arm study including Jakafi might be a potential path. They also said the next-generation program is designed for faster dose escalation and to start pivotal trials quickly, with a goal to begin pivotal trials in 2028.
"Right now, we continue to develop 989 to try to address the needs of all patients with CALR mutations." — Pablo Cagnoni
DAWN-302 population and control arm expectations
Q (Amit Amin · H.C. Wainwright): The analyst asked what supports replacing second-line chemo with the 734+cetuximab combo and whether the DAWN-302 second-line cohort will be large enough to show benefit separate from third-line results.
A: Management said they expect the study will be driven toward third-line patients because the control arm allows LONSURF+Bev, regorafenib, or fruquintinib, and therefore the trial population will likely shift later. They added they expect the DAWN-302 control arm to underperform the overall SUNLIGHT study because DAWN-302 will be in Bev-exposed patients, which supports a higher probability of success for DAWN-302 relative to that benchmark.
"I expect that the study will involve predominantly third-line patients because the control arm will allow LONSURF Bev, which was the winning arm of the SUNLIGHT study, as well as regorafenib or fruquintinib." — Pablo Cagnoni
povorcitinib label scenarios for HS
Q (Jacob · Wells Fargo): The analyst asked about possible label scenarios for povorcitinib in HS and which analogs to consider for launch planning.
A: Management said there are two basic label scenarios: a pre- and post-biologic population (preferred) or a post-biologic population only, and both are workable paths. They said they are planning for both plausible outcomes and believe the data can support a broad label, with analog choices depending on the final dataset.
"We studied both a pre- and post-biologic population, and so that would be clearly the preferred label scenario." — Bill Meury
INCA036978 target and OPZELURA in HS upside
Q (Imogen Mansfield · Cantor Fitzgerald): The analyst asked what INCA036978 targets and whether it is CALR, and also asked about OPZELURA peak sales potential in mild-to-moderate HS.
A: Management said they will not disclose the target now but described the antibody as mutation-agnostic and potentially targeting CALR, V617F, and MPL. They also said there may be a couple hundred thousand mild-to-moderate HS patients and that capturing 10%–15% could be a 5%–10% lift for OPZELURA, potentially producing $50 million–$100 million incremental sales depending on the data.
"If you picked up 10%-15% of that or more, it could be a 5%-10% lift on OPZELURA." — Bill Meury
954 (V617F) clinic timing and preclinical signs
Q (Tara Bancroft · TD Cowen): The analyst asked when 954 (V617F) will enter the clinic and what preclinical data would indicate an improved clinical profile versus 958.
A: Management said the next-gen V617F program 954 will enter the clinic in early 2027 (no exact date disclosed). They said they improved selectivity between wild type and V617F mutant cells (not JAK1/JAK2 selectivity), improved formulation, and saw better preclinical toxicology on the margin versus the prior program, which supports moving the program forward.
"The entry in the clinic for next-gen, the V617F nine five four, will be early 2027." — Pablo Cagnoni