– Total FY’22 net product revenues grew 18% to $2.75 billion; total FY’22 revenues of $3.4 billion (+14% Y/Y)
– Jakafi® (ruxolitinib) net revenues of $647 million (+9% Y/Y) in Q4’22 and $2.41 billion (+13%) in FY’22; Jakafi net revenues guidance range of $2.53 – $2.63 billion for FY 2023
– Opzelura™ (ruxolitinib) Cream net revenues of $61 million in Q4’22 and $129 million in FY’22, driven by strong demand in atopic dermatitis, a successful launch in vitiligo and broadening formulary access
Conference Call and Webcast Scheduled Today at 8:00 a.m. ET
WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today reports 2022 fourth quarter financial results, provides 2023 financial guidance and provides a status update on the Company’s clinical development portfolio.
“We are well positioned for strong growth with our current product portfolio and we expect to deliver many important updates this year as we continue to execute on our growth and diversification strategy.”
“We are entering 2023 with significant momentum, following a year of strong commercial performance and progress of several important mid-to-late stage programs across our pipeline. Opzelura has now become the market share leader among branded agents for new atopic dermatitis patients and the adoption in vitiligo has been strong,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “We are well positioned for strong growth with our current product portfolio and we expect to deliver many important updates this year as we continue to execute on our growth and diversification strategy.”
Portfolio Updates
MPNs and GVHD – key highlights
LIMBER (Leadership In MPNs and GVHD BEyond Ruxolitinib) program: Important LIMBER updates were presented at the American Society of Hematology (ASH) Annual Meeting in December 2022:
- Parsaclisib + ruxolitinib in myelofibrosis (MF): Final results from the Phase 2 trial in MF patients with a suboptimal response to ruxolitinib demonstrated additional spleen volume response and symptom improvement with the addition of parsaclisib. Add-on parsaclisib was generally well-tolerated. A Phase 3 trial evaluating parsaclisib as an add-on to ruxolitinib in suboptimal responders is ongoing with results expected at the end of 2023.
- Zilurgisertib (ALK2) ± ruxolitinib in MF: Initial results from the Phase 1 study evaluating zilurgisertib as monotherapy or in combination with ruxolitinib in patients with anemia due to MF were presented, establishing proof of mechanism in improving anemia. Updated combination data with ruxolitinib are expected later this year.
- INCA33989 (mCALR) in MF and essential thrombocythemia (ET): A novel anti-mutant calreticulin (mCALR) monoclonal antibody was unveiled during the ASH plenary session. These data highlight Incyte’s discovery capabilities and research progress in MF and ET; two patient populations where 25-35% of patients have a CALR mutation. INCA33989 is expected to enter the clinic later this year.
Ruxolitinib extended release (XR) formulation: The New Drug Application (NDA) was accepted by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of March 23, 2023.
Axatilimab in chronic graft-versus-host disease (GVHD): In December, Syndax and Incyte announced that results from the Phase 1/2 trial of axatilimab in patients with recurrent or refractory chronic GVHD following two or more prior lines of therapy were published in the Journal of Clinical Oncology. The data demonstrate that treatment with axatilimab resulted in an overall response rate (ORR) by cycle 7, day 1 of 67% across all patients. AGAVE-201, a global pivotal Phase 2 trial of axatilimab in patients with cGVHD, is ongoing with results expected mid-2023. A Phase 1/2 combination trial of axatilimab with ruxolitinib in patients with newly-diagnosed cGVHD is expected to initiate later this year.
Jakafi patent extension: Incyte was granted pediatric exclusivity which adds six months to the expiration for all ruxolitinib patents, thereby extending the patent expiry for Jakafi through December 2028.
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Indication and status |
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Ruxolitinib XR (QD) (JAK1/JAK2) |
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Myelofibrosis, polycythemia vera and GVHD: NDA under review |
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Ruxolitinib + parsaclisib (JAK1/JAK2 + PI3Kδ) |
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Myelofibrosis: Phase 3 (first-line therapy) (LIMBER-313) Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) (LIMBER-304) |
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Ruxolitinib + INCB57643 (JAK1/JAK2 + BET) |
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Myelofibrosis: Phase 2 |
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Ruxolitinib + zilurgisertib (JAK1/JAK2 + ALK2) |
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Myelofibrosis: Phase 2 |
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Ruxolitinib + CK08041 (JAK1/JAK2 + CB-Tregs) |
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Myelofibrosis: Phase 1 (LIMBER-TREG108) |
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Axatilimab (anti-CSF-1R)2 |
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Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201) |
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Ruxolitinib + axatilimab2 (JAK1/JAK2 + anti-CSF-1R) |
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Chronic GVHD (newly diagnosed): Phase 1/2 in preparation |
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1 |
Development collaboration with Cellenkos, Inc. |
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Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. |