Incyte Q1 Earnings Call Highlights

Key Points

• Strong start to 2026: Q1 revenue rose 21% to $1.27 billion and net sales were up 20% to $1.1 billion (Jakafi $758M), Incyte reaffirmed full‑year 2026 net sales guidance of $4.77–$4.94 billion while investing more in late‑stage programs, which lifted R&D and operating expenses.
• Povorcitinib momentum: The FDA accepted the HS filing and two Phase III vitiligo trials (STOP‑V1/STOP‑V2) met primary endpoints with the 30 mg dose showing robust F‑VASI75 responses and a consistent 52‑week safety profile, supporting a planned regulatory submission in H1 2027.
• Broader late‑stage pipeline and commercial gains: Hematology/oncology sales jumped 116% to $204M led by Niktimvo, Monjuvi and Zynyz, and Incyte is advancing pivotal Phase III programs including INCA033989 (mutant CALR) and KRAS G12D inhibitor INCB161734 in first‑line PDAC.

Incyte NASDAQ: INCY reported what management described as a strong start to 2026, driven by broad-based demand across its commercial portfolio and continued advancement of multiple late-stage pipeline programs. During the company’s first-quarter earnings call, executives highlighted 20% year-over-year net sales growth, regulatory progress for povorcitinib in hidradenitis suppurativa (HS), and newly announced positive phase III results for povorcitinib in nonsegmental vitiligo.

First-quarter results show broad portfolio growth

Chief Executive Officer Bill Meury said first-quarter total revenue rose 21% year-over-year to $1.27 billion, while net sales increased 20% to $1.1 billion. “Sales increased for every marketed product, both in the U.S. and internationally, and was driven by strong prescription and volume demand across the portfolio,” Meury said.

Jakafi first-quarter sales were $758 million, up 7% year-over-year. Meury said prescription demand increased 6% with “broad-based growth across all indications, MF, PV, and GVHD,” adding that new patient starts remained strong and formulary coverage remained broad. Incyte anticipates approval and launch of Jakafi XR in the middle of the year, and Meury said the company estimates the extended-release product could reach 10% to 30% of Jakafi’s business by 2029.

Excluding Jakafi, Meury said Incyte’s “core business” grew 63% year-over-year, supported by contributions across hematology, oncology, and immunology. Opzelura sales totaled $143 million, up 20% from the prior year, including $106 million in the U.S. (up 12%) and $37 million internationally (up 56%). Meury said underlying U.S. prescription demand for Opzelura rose 17% year-over-year. He reiterated that Opzelura remains under review in Europe for moderate atopic dermatitis, with approval and launch expected in the second half of 2026.

In hematology and oncology, net sales grew 116% to $204 million. Meury said Niktimvo, Monjuvi, and Zynyz were the largest contributors. Niktimvo recorded $55 million in first-quarter sales; Meury said “virtually every BMT center in the U.S.” is using the product and that it has captured 32% of the third-line-plus market within 12 months. Monjuvi sales were $49 million, up 67% year-over-year, driven by uptake in follicular lymphoma after approvals in the U.S. and international markets. Zynyz sales were $41 million, with Meury citing “rapid and robust adoption” in squamous cell anal carcinoma (SCAC).

Guidance reaffirmed; expenses rise with late-stage investment

VP and Chief Accounting Officer Tom Tray said GAAP R&D expenses were $516 million, up 18% year-over-year, reflecting continued investment in late-stage programs including INCA033989 (mutant CALR), INCB161734 (KRAS G12D), and INCB123667 (CDK2). GAAP SG&A was $328 million, up 1% year-over-year. Tray said ongoing operating expenses rose 14% versus a 19% increase in ongoing revenues, contributing to “a continued increase in operating leverage and margins.”

Tray said the company reaffirmed full-year 2026 guidance, including total net sales of $4.77 billion to $4.94 billion (10% to 13% growth year-over-year). The outlook includes:

• Jakafi net sales of $3.22 billion to $3.27 billion
• Opzelura net sales of $750 million to $790 million
• Hematology and oncology product net sales of $800 million to $880 million

Total GAAP R&D and SG&A operating expenses are expected to be $3.495 billion to $3.675 billion, while cost of sales is expected to remain about 9% of net sales.

Povorcitinib advances in HS and vitiligo

Meury said the FDA accepted Incyte’s regulatory application for povorcitinib in moderate to severe HS, noting the filing was submitted ahead of schedule and supported by data across both pre- and post-biologic patients. He positioned 2026 as a year in which the company is “transition[ing] Incyte beyond a single cornerstone product,” with povorcitinib among the programs intended to help build the next phase of growth beyond Jakafi.

During the call, Incyte also announced positive results from two phase III registration studies of povorcitinib in adults with nonsegmental vitiligo. President and Global Head of R&D Pablo J. Cagnoni said the STOP-V1 and STOP-V2 trials enrolled more than 900 patients and evaluated povorcitinib versus placebo for 52 weeks. He said povorcitinib achieved the primary endpoint in both studies: at week 52, patients receiving a 30 mg dose demonstrated statistically significant and clinically meaningful improvements versus placebo on F-VASI 75 (at least a 75% reduction in Facial Vitiligo Area Scoring Index). He added that statistically significant improvements were also seen on key secondary measures, including T-VASI 50 at week 52.

Cagnoni said the 30 mg dose was well-tolerated and that the overall 52-week safety profile was consistent with prior studies, with no new safety signals observed. He said treatment-emergent adverse events of special interest were low (2% to 3%) and similar between povorcitinib and placebo groups, and “there were no major adverse cardiovascular events.” He noted one VTE event in the povorcitinib group occurred in a patient with multiple confounding risk factors. Cagnoni said the results support a regulatory application planned for the first half of 2027, and that additional data are expected to be shared in the second half of 2026. He also said data in prurigo nodularis are expected by year-end.

Late-stage pipeline: CALR, KRAS G12D, and other pivotal programs

In hematology, Cagnoni detailed progress for INCA033989 (referred to as “989”), a mutant CALR monoclonal antibody. He said Incyte had a positive end-of-phase meeting with the FDA and plans to initiate a phase III study in previously treated essential thrombocythemia (ET) patients with mutant CALR by mid-year. The phase III trial will compare 989 to best available therapy in type 1 and non-type 1 mutant CALR-positive ET patients who are resistant or intolerant to at least one prior cytoreductive therapy, using a flexible dosing schedule that begins at 750 mg IV every two weeks with a single escalation option to 2,500 mg based on early platelet response. The primary endpoint is durable complete hematologic response at week 24, with mutant CALR variant allele frequency reduction as a key secondary endpoint.

On the call, Cagnoni said the company expects a “pretty substantial” update at EHA, citing longer follow-up, expanded enrollment, and more translational data. He said Incyte expects to report ET data in approximately 100 patients and myelofibrosis (MF) data in about 40 to 45 second-line single-agent patients plus roughly 15 to 16 patients in combination with ruxolitinib.

In oncology, Cagnoni said Incyte initiated a phase III study of KRAS G12D inhibitor INCB161734 in combination with chemotherapy in first-line pancreatic ductal adenocarcinoma (PDAC). He emphasized the combination profile with standard chemotherapy regimens and said the company plans to share efficacy and safety data from the phase I combination studies in first-line PDAC in the second half of 2026. He also clarified that the phase III study was never paused following a review of pneumonitis events; Europe temporarily held phase I enrollment for administrative updates to consent forms and the investigator brochure, while U.S. enrollment continued.

Cagnoni also outlined ongoing pivotal programs including a phase III study of INCA33890 in combination with FOLFOX bevacizumab in first-line MSS colorectal cancer, and the MAESTRO program for CDK2 inhibitor INCB123667 in platinum-resistant ovarian cancer with cyclin E1 overexpression. He said a planned phase III first-line maintenance study is expected to begin in the second half of 2026.

Commercial strategy and leadership updates

Management discussed how povorcitinib could coexist with Opzelura in vitiligo, with Meury describing a “topical to oral solution” that could support natural treatment sequencing. EVP and Head of U.S. Commercial Mohamed Issa said Incyte estimates 1.5 million people in the U.S. are living with vitiligo, with 20% to 30% seeking treatment. He said patients with lower body surface area involvement may be well-suited to topical therapy, while patients with BSA greater than 10 may be more likely to use systemic therapy.

Meury also highlighted executive changes, including the appointment of Suketu Upadhyay as Chief Financial Officer, Pablo J. Cagnoni as President and Global Head of R&D, Steven Stein as EVP, Chief Medical Officer and Head of Late-stage Development, and Mohamed Issa as EVP and Head of U.S. Commercial. Meury said U.S. commercial operations have been integrated into a single organization to establish consistent capabilities across analytics, market access, sales operations, and patient services, with the goal of creating a “launch-ready organization in 2026.”

About Incyte NASDAQ: INCY

Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company's research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases.

The company's flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera.

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