Incyte Announces Q4 and Full-Year 2024 Financial Results, Shares 2025 Guidance and R&D Milestones
Incyte reported its financial results for the fourth quarter and full year ended December 31, 2024. The company also provided its financial outlook for 2025 and outlined key research and development (R&D) milestones expected in the coming year.
Strong 2024 Performance and Growth Outlook
“Incyte had a transformative year in 2024, achieving a 15% increase in total revenues, fueled by the robust performance of Jakafi and Opzelura, along with significant advancements in our R&D pipeline,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “As we enter 2025, we anticipate continued revenue growth and strategic diversification, with several pivotal milestones poised to drive further innovation and market expansion. Our long-term goal remains to launch more than 10 impactful products by 2030, and 2025 is set to be a defining year in achieving that objective.”
2025: A Pivotal Year for Incyte’s R&D Pipeline
Incyte is preparing for an ambitious 2025, with at least 18 critical milestones expected across its diverse therapeutic portfolio, including:
- Four new product launches:
- Niktimvo™ (axatilimab-csfr) for 3L+ chronic graft-versus-host disease (GVHD)
- Ruxolitinib cream (Opzelura®) for pediatric atopic dermatitis (AD)
- Tafasitamab (Monjuvi®) for relapsed/refractory follicular lymphoma (FL)
- Retifanlimab (Zynyz®) for squamous cell anal carcinoma (SCAC)
- Three pivotal Phase 3 study initiations:
- BET inhibitor for 2L myelofibrosis (MF)
- Ruxolitinib cream for mild-to-moderate hidradenitis suppurativa (HS)
- CDK2 inhibitor for ovarian cancer
- Four pivotal data readouts:
- Povorcitinib in moderate-to-severe HS
- Ruxolitinib cream in prurigo nodularis (PN)
- Tafasitamab in first-line diffuse large B-cell lymphoma (DLBCL)
- Ruxolitinib XR in MF, polycythemia vera (PV), and GVHD
- Seven proof-of-concept data readouts:
- Povorcitinib in chronic spontaneous urticaria (CSU) and asthma
- mutCALR inhibitor in MF and essential thrombocythemia (ET)
- JAK2V617F-specific inhibitor in MF
- KRASG12D and TGFβR2xPD-1 inhibitors in solid tumors
Recent Corporate Highlights
- A bioequivalence study of ruxolitinib XR was completed, with data expected to be submitted to the FDA by year-end 2025.
- Niktimvo™ (axatilimab-csfr) received FDA approval in January 2025 and is now commercially available in the U.S.
- Tafasitamab’s Phase 3 inMIND trial demonstrated a statistically significant improvement in progression-free survival (PFS) in patients with relapsed/refractory FL. FDA approval is expected in the second half of 2025.
- Incyte presented BET inhibitor (INCB057643) data at the 2024 ASH Annual Meeting, showing promising efficacy in MF and advanced myeloid neoplasms. A Phase 3 study in post-Jakafi patients is planned for 2025.
- Retifanlimab’s supplemental Biologics License Application (sBLA) was submitted to the FDA for SCAC, with approval anticipated in late 2025.
- Opzelura’s sNDA for pediatric atopic dermatitis was submitted to the FDA, with approval expected in the second half of 2025.
Jakafi and Opzelura Performance
- Jakafi:
- Q4 2024 net product revenue: $773 million (11% increase YoY)
- FY 2024 revenue: $2.79 billion (8% increase YoY)
- Revenue growth driven by strong demand across indications
- Opzelura:
- Q4 2024 net product revenue: $162 million (48% increase YoY)
- FY 2024 revenue: $508 million (50% increase YoY)
- Growth fueled by patient demand for atopic dermatitis and vitiligo treatment, as well as increasing contributions from Europe
Pipeline and Clinical Updates
Myeloproliferative Neoplasms (MPNs) & Graft-Versus-Host Disease (GVHD)
- Phase 1 studies evaluating mutCALR inhibitor in MF and ET and JAK2V617F-specific inhibitor in MF are ongoing, with proof-of-concept data expected in 2025.
- A Phase 2 study of axatilimab (Niktimvo™) in combination with ruxolitinib for newly diagnosed chronic GVHD is enrolling patients.
- A Phase 3 trial evaluating axatilimab plus corticosteroids in chronic GVHD is now underway.
Hematology & Oncology
- Incyte is launching a Phase 3 study for its CDK2 inhibitor (INCB123667) in ovarian cancer in 2025.
- Tafasitamab’s Phase 3 frontMIND study in first-line DLBCL is ongoing, with pivotal data expected in early 2025.
- Early-stage studies evaluating KRASG12D and TGFβR2×PD-1 inhibitors in solid tumors are progressing, with initial proof-of-concept data anticipated in 2025.
Inflammation & Autoimmunity (IAI) and Dermatology
- Two Phase 3 trials of ruxolitinib cream in PN are fully enrolled, with data expected in early 2025.
- A Phase 3 study of ruxolitinib cream in HS is set to begin following regulatory alignment.
- Opzelura received Swissmedic approval for non-segmental vitiligo with facial involvement in patients 12+ years old.
- Povorcitinib Phase 3 studies in HS are fully enrolled, with results anticipated in early 2025.
