Incyte Reports 2023 Third Quarter Financial Results and Provides Updates on Key Clinical Programs

Published

– Total revenues of $919 million in the third quarter (Q3'23) (+12% Y/Y)

– Jakafi® (ruxolitinib) net product revenues of $636 million (+3% Y/Y) in Q3'23, $1.9 billion (+8% Y/Y) YTD 2023, driven by growth in total patients across all indications; tightening full year 2023 guidance to a new range of $2.59 - $2.62 billion

– Opzelura® (ruxolitinib) cream net product revenues of $92 million (+141% Y/Y) in Q3'23, $229 million YTD 2023; continued uptake in atopic dermatitis (AD) and vitiligo and enhanced payer coverage

– Phase 2 study evaluating povorcitinib in prurigo nodularis (PN) met its primary endpoint

Conference Call and Webcast Scheduled Today at 8:00 a.m. ET

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today reports 2023 third quarter financial results, and provides a status update on the Company’s clinical development portfolio.

"Our double-digit revenue growth during the quarter was driven by sustained performance of Jakafi® (ruxolitinib) and an increasing contribution from Opzelura® (ruxolitinib) with continued strong patient demand and enhanced payer coverage," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We made significant progress with our early programs in myeloproliferative neoplasms (MPNs), including mCALR and JAK2V617F, which have the potential to be disease modifying therapies that represent a fundamentally new approach to the way patients with MPNs are treated. Additionally, we recently received positive top line results from the Phase 2 study of povorcitinib in prurigo nodularis (PN) and plans are underway to initiate a Phase 3 study in 2024. With approximately 100,000 treated PN patients in the U.S., povorcitinib has the potential to be an efficacious therapy for those patients who currently have limited treatment options.”

Key Company Updates

  • In September, Incyte was notified by the Centers for Medicare and Medicaid Services that ruxolitinib phosphate qualified for the Small Biotech Exception.
  • Beginning January 1, 2024, Opzelura will be listed as a Preferred Brand on the CVS Caremark and Aetna formularies impacting roughly 30 million commercial lives in the U.S.

Key Product Sales Performance

Jakafi:

Net product revenues for the quarter of $636 million:

  • Net product revenues grew 3% compared with the third quarter of 2022.
  • Channel inventory at the end of the third quarter of 2023 decreased by approximately $14 million versus the second quarter of 2023. Underlying demand in the third quarter of 2023 continued to grow both year-over-year and quarter-over-quarter.

Opzelura:

Net product revenues for the quarter of $92 million:

  • Net product revenues of $92 million grew 141% compared with the third quarter of 2022, driven by growth in patient demand, refills and expansion in payer coverage as the launch in AD and vitiligo continues.

Pipeline Updates

Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights

  • Combination trials of ruxolitinib twice daily (BID) with zilurgisertib (ALK2) and INCB57643 (BET) are ongoing and continue to enroll. Additional data from these studies are anticipated to be shared in the fourth quarter of 2023.
  • The Phase 1 study evaluating INCA033989 (mCALR) is ongoing and enrolling patients.
  • In October, we announced the development of a new program targeting the JAK2V617F mutation, which is present in 55-60% of myelofibrosis (MF) and essential thrombocythemia (ET) patients, and in 95% of polycythemia vera (PV) patients. INCB100658 is a small molecule inhibitor, targeting the JAK2V617F mutation and we expected to file the IND by year-end 2023.
 

 

 

Indication and status

Ruxolitinib XR (QD)

(JAK1/JAK2)

 

Myelofibrosis, polycythemia vera and GVHD

Ruxolitinib + zilurgisertib

(JAK1/JAK2 + ALK2)

 

Myelofibrosis: Phase 2

Ruxolitinib + INCB57643

(JAK1/JAK2 + BET)

 

Myelofibrosis: Phase 2

Ruxolitinib + CK08041

(JAK1/JAK2 + CB-Tregs)

 

Myelofibrosis: Phase 1 (LIMBER-TREG108)

Axatilimab (anti-CSF-1R)2

 

Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201)

Ruxolitinib + axatilimab2

(JAK1/JAK2 + anti-CSF-1R)

 

Chronic GVHD: Phase 1/2 in preparation

INCA033989

(mCALR)

 

Myelofibrosis, essential thrombocythemia: Phase 1

1 Development collaboration with Cellenkos, Inc.

2 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.

Other Hematology/Oncology – key highlights

Oral small molecule PD-L1 program: Combination studies evaluating INCB99280 in combination with axitinib (VEGF) and in combination with ipilimumab (CTLA-4) are enrolling. Two Phase 2 monotherapy studies evaluating INCB99280 in patients with select solid tumors who are checkpoint inhibitor naive and in metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC, are enrolling.

 

 

Indication and status

Pemigatinib (Pemazyre®)

(FGFR1/2/3)

 

Myeloid/lymphoid neoplasms (MLN): approved in the U.S. and Japan

Cholangiocarcinoma (CCA): Phase 3 (FIGHT-302)

Glioblastoma: Phase 2 (FIGHT-209)

Tafasitamab (Monjuvi®/Minjuvi®)1

(CD19)

 

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)

First-line DLBCL: Phase 3 (frontMIND)

Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (inMIND)

Retifanlimab (Zynyz®)2

(PD-1)

 

Merkel cell carcinoma (MCC): approved in the U.S.

Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303)

Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)

MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)

INCB99280

(Oral PD-L1)

 

Solid tumors (combination): Phase 1

Solid tumors (monotherapy): Phase 2

Cutaneous squamous cell carcinoma (cSCC): Phase 2

INCB99318

(Oral PD-L1)

 

Solid tumors: Phase 1

1 Development of tafasitamab in collaboration with MorphoSys.

2 Retifanlimab licensed from MacroGenics.

3 Clinical trial collaboration and supply agreement with Mirati Therapeutics.

Inflammation and Autoimmunity (IAI) – key highlights

Dermatology

Opzelura

  • New results of a pooled analysis of long-term extension (LTE) data from the pivotal Phase 3 TRuE-V program assessing Opzelura cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo who previously experienced limited or no response to treatment at Week 24 were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023 as a late-breaking oral presentation . These results showed patients who initially experienced limited or no facial or total body repigmentation at six months achieved improved repigmentation after continued treatment with Opzelura for up to two years.
  • Expanded results from the pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in children (age ≥2 to

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