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

– Total net product revenues of $693 million in Q1'23 (+14% Y/Y)

– Jakafi® (ruxolitinib) net product revenues of $580 million (+7% Y/Y) in Q1'23; raising the bottom end of full year guidance to new range of $2.55 - $2.63 billion for FY 2023

– Opzelura® (ruxolitinib) cream approved as the first and only treatment for repigmentation of nonsegmental vitiligo in Europe; continued strong U.S. launch in atopic dermatitis and vitiligo

– Multiple positive data readouts from dermatology portfolio at AAD and EHSF 2023

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

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

"Our first quarter results demonstrate continued year-over-year double-digit revenue growth driven by Jakafi, which grew across all indications, and Opzelura, which is on track to become one of the most successful dermatology launches in recent years. In addition, we further expanded our commercial portfolio with several regulatory approvals including Opzelura for vitiligo in Europe.” said Hervé Hoppenot, Chief Executive Officer, Incyte. "Furthermore, in Q1 we made a decision to focus our development efforts on eight programs that have high potential value for us and discontinued six other programs. This allows us to optimize our allocation of resources on programs that can have a high impact for patients and for Incyte."

Key Product Sales Performance

Jakafi:

Net product revenues of $580 million:

• Net product revenues grew 7% compared with the first quarter of 2022, driven by strong underlying patient demand growth (+7% Y/Y) including an 8% growth in new patients. Total patients grew across myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).

• Net product revenues were unfavorably impacted by:
  • Higher gross-to-net deductions, compared to fourth quarter of 2022, as a result of the Medicare coverage gap and higher commercial patient deductibles at the beginning of the plan year, as well as an increase in 340B orders.
  • Lower than normal levels of channel inventory at the end of Q1, representing an $11 million impact.

Opzelura:

Net product revenues of $57 million:

• Net product revenues grew 343% compared with the first quarter of 2022, driven by growth in patient demand and expansion in payer coverage as the launch in atopic dermatitis (AD) and vitiligo continues.

• Compared to the fourth quarter of 2022, net product revenues were unfavorably impacted by:
  • Increase in co-pay assistance due to higher commercial patient deductibles at the beginning of the plan year, consistent with first quarter dynamics and higher Medicaid utilization volume.
  • Acceleration of refills in December 2022 driven by patient demand in advance of annual deductible reset or health plan changes that negatively impacted refills during the months of January and February this year.

Pipeline Updates

MPNs and GVHD – key highlights

LIMBER (Leadership In MPNs and GVHD BEyond Ruxolitinib): Our LIMBER development program encompasses multiple monotherapy and combination strategies, with the goal of improving upon the standard of care in MF, PV, GVHD and now, essential thrombocythemia (ET).

• Combination trials of ruxolitinib BID with zilurgisertib (ALK2) and INCB57643 (BET) are ongoing and progressing well.

• In early development, INCA33989 (mCALR) is on track for initiating first-in-human study in MF and ET in 2023. Additionally, a Phase 1 study evaluating ruxolitinib BID in combination with Cellenkos' CK0804 in MF is continuing to recruit patients.

• AGAVE-201, a global pivotal Phase 2 trial of axatilimab in patients with cGVHD is ongoing and results are on track for mid-2023. A Phase 1/2 combination trial of axatilimab in combination with ruxolitinib is being planned.

• The Phase 3 LIMBER-304 trial, evaluating parsaclisib in combination with ruxolitinib BID in suboptimal responders in MF and the Phase 3 LIMBER-313 trial, evaluating parsaclisib in combination with ruxolitinib BID in first-line MF, were discontinued following results of interim analyses that indicated that the studies were unlikely to meet their primary endpoints in the intent-to-treat patient population. The studies were not stopped due to safety.

• The U.S. Food and Drug Administration (FDA) issued a complete response letter for ruxolitinib extended-release (XR) tablets for once-daily (QD) use in the treatment of certain types of MF, PV and GVHD. Incyte will work with the FDA to determine appropriate next steps.

Other Hematology/Oncology – key highlights

Zynyz™ (retifanlimab-dlwr) approved for Merkel cell carcinoma in the U.S.: Zynyz, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), received accelerated approval for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This represents the first regulatory approval for Incyte's PD-1 inhibitor, which is also being evaluated in pivotal trials in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the anal canal (SCAC).

Monjuvi® (tafasitamab-cxix)/Minjuvi® (tafasitamab): Minjuvi continues to launch in new ex-US markets, having gained reimbursement in two additional countries this quarter, bringing the total of launch markets to six. At the American Association for Cancer Research (AACR), final five-year follow-up data from the Phase 2 L-MIND study were presented, which showed that Monjuvi plus lenalidomide followed by Monjuvi monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Pemazyre® (pemigatinib) continues to expand in ex-U.S. markets in cholangiocarcinoma and myeloproliferative neoplasms (MLNs): Pemazyre was approved in Japan by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of MLNs with FGFR1 fusion. MLNs are a rare, aggressive group of cancers characterized by an over-production of myeloid cells, or bone tissue, with the tendency to rapidly progress to an acute myeloid leukemia (AML). The launch of Pemazyre in cholangiocarcinoma (CCA) is ongoing in 10 key markets in Europe. In clinical development, FIGHT-210, evaluating pemigatinib in NSCLC, was discontinued.

Parsaclisib in warm autoimmune hemolytic anemia (wAIHA): Based on the challenging regulatory landscape associated with the PI3K class, development of parsaclisib in wAIHA has been discontinued.

Inflammation and Autoimmunity (IAI) – key highlights

Dermatology

Opzelura

• Opzelura approved for vitiligo in Europe: Opzelura was approved by the European Commission for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents 12 years of age and older. The EC decision is based on data from two pivotal Phase 3 clinical trials (TRuE-V1 and -V2), which showed treatment with Opzelura resulted in significant improvements in facial and total body repigmentation versus vehicle at Week 24 and among completers of an open-label extension at Week 52. Opzelura was well-tolerated with no serious treatment-related adverse events related to ruxolitinib cream.

• Opzelura 104-week safety and efficacy data in vitiligo provide insights into the value of long-term treatment: 104-week results from the long-term extension of the Phase 3 TRuE-V study were presented at the American Academy of Dermatology (AAD) Annual Meeting. The data demonstrated that many patients who achieved a high level of facial repigmentation (≥F-VASI90) at Week 52 were able to maintain durable response one year following withdrawal of treatment. In patients who did not achieve ≥F-VASI90 at Week 52 and continued treatment with Opzelura, improvements in facial and total body repigmentation, as shown by greater proportions of patients reaching F-VASI75 and T-VASI50, were observed through Week 104.

• Ruxolitinib cream in pediatric atopic dermatitis (AD): A Phase 3 trial of ruxolitinib cream in pediatric AD has completed enrollment with results expected by end of year. There are an estimated 2-3 million pediatric AD patients (ages 2-11) in the United States.

• Ruxolitinib cream in other indications: Incyte continues to expand the development of ruxolitinib cream into new indications as we seek to maximize the potential opportunity with the franchise. Phase 2 trials evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS), lichen planus (LP) and lichen sclerosus (LS) are ongoing. Additionally, two Phase 3 trials evaluating ruxolitinib cream in prurigo nodularis (PN) were initiated.

Povorcitinib

• Phase 2 results in hidradenitis suppurativa: 52-week results from the Phase 2 study evaluating povorcitinib (15mg QD, 45mg QD, 75mg QD) in HS were presented as an oral presentation at the European Hidradenitis Suppurativa Foundation (EHSF) Annual Meeting. The data demonstrated that continuation of treatment with povorcitinib 75 mg resulted in sustained and durable efficacy across all treatment arms, and importantly, 22-29% of patients treated for 52-weeks achieved HiSCR100, which is defined as a 100% reduction from baseline in total abscess and nodule (AN) count with no increase from baseline in abscess or draining tunnel count. Povorcitinib is currently in two Phase 3 studies in moderate to severe HS.

• Phase 2 results in vitiligo: 36-week results from the Phase 2b study evaluating povorcitinib in patients with extensive vitiligo were presented as an oral late-breaking presentation at the American Academy of Dermatology (AAD) Annual Meeting. The data demonstrated that treatment with oral povorcitinib was associated with substantial total body repigmentation in patients with extensive nonsegmental vitiligo, as measured by total Vitiligo Area Scoring Index (T-VASI) scores. Specifically, the study met its primary endpoint, and patients receiving povorcitinib experienced statistically superior improvements in T-VASI at Week 24 compared to placebo (povorcitinib 15 mg, –19.1%; 45 mg, –17.8%; 75 mg, –15.7% vs. placebo, +2.3%; least squares mean [LSM] difference, P