Incyte Q4 2022: Total Revenues Hit $3.4 Billion, with New Drug Opzelura Growing Fast
By Mark Terry
February 7, 2023
Incyte, headquartered in Wilmington, Del., reported its fourth quarter, full-year 2022 financials, and 2023 guidance. The company reported quarterly revenues of $926.7 million with full-year revenues of $3.393 billion.
In the conference call with investors, company CEO Hervé Hoppenot noted that “2022 was another successful year in which we delivered strong performance and made significant progress across our oncology and dermatology pipeline.”
Although the company’s Jakafi/Jakavi (ruxolitinib) is its leading product, raking in $647.5 million for the quarter and $2.4 billion for the year, much of the focus was on the company’s newest drug, Opzelura (ruxolitinib) cream. Opzelura is indicated for topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in people 12 years and older. In July 2022, it was approved in the U.S. for nonsegmental vitiligo, the first FDA-approved drug to address repigmentation in these patients.
Hoppenot said, “Opzelura is a significant growth driver for Incyte…. Its launch has been very successful.”
Since its launch, 190,000 patients have been treated for vitiligo. Sales for 2022 were $129 million.
Growth for Opzelura is coming from both indications, with net product revenues hitting $61 million in the fourth quarter, a growth of 61% compared to the third. Incyte is also currently running a Phase III trial of the drug in pediatric atopic dermatitis with results expected by the end of the year. About 2 million pediatric AD patients between the ages of 2 to 11 are in the U.S. alone. The drug is also under review at the European Medicines Agency (EMA) with a Committee for Medicinal Products for Human Use (CHMP) opinion expected in the first half of this year.
The company is also working to expand Opzelura into new indications. In December, the company initiated a Phase II trial for mild to moderate hidradenitis suppurativa. Two Phase II trials are ongoing as well, one for lichen planus (LP) and lichen sclerosus (LS).
For the year, Incyte saw five regulatory approvals. Opzelura was approved in the U.S. for vitiligo. Pemazyre (pemigatinib) was approved in the U.S. for MLN with FGFR1 rearrangements. Jakavi was approved for acute and chronic graft-versus-host disease (GVHD) in Europe. Olumiant (baricitinib) was approved for alopecia areata (AA) in the U.S., Europe and Japan. And Tabrecta (capmatinib) was approved for non-small cell lung cancer (NSCLC) with MET exon-14 mutations in Europe.
Hopponet said the company’s four main drivers of sustainable growth were Jakafi with its LIMBER program (Leadership in MPNs and GVHD Beyond Ruxolitinib), Opzelura with more indications, the company’s strategic clinical development in oncology and dermatology, and its powerful discovery engine.
Barry Flannelly, Incyte’s General Manager, North America, noted that one of the key drivers of Jakavi for GVHD was the typical duration of treatment was 15 months. “We expect continued growth,” Flannelly said.
Speaking on the company’s clinical development program, Steven Stein, Chief Medical Officer, said that “Incyte made significant progress across our clinical portfolio for 2022” and they expect “multiple updates from the LIMBER program this year.”
The LIMBER program has three areas of focus: a once-daily formulation of ruxolitinib; ruxolitinib-based combinations with new targets such as PI3Kδ, BET and ALK2; and new therapeutic options.
The company also has a target action date with the FDA for Ruxolitinib XR (extended release) in March.
In December, Incyte presented LIMBER updates at the American Society of Hematology (ASH) meeting. This included final results from the Phase II trial of parsaclisib plus ruxolitinib in myelofibrosis patients with a suboptimal response to ruxolitinib. The trial showed additional spleen volume response and symptom improvement and the combination was generally well-tolerated. A Phase III trial of parsaclisib as an add-on to ruxolitinib in suboptimal responders is ongoing with a readout expected at the end of this year.
Incyte presented initial results from the Phase I trial of zilurgisertib as a monotherapy or in combination with ruxolitinib in anemia patients due to myelofibrosis. It demonstrated proof of mechanism in improving anemia. Additional combination data is expected later this year.
The company also presented a new novel anti-mutant calreticulin (mCALR) monoclonal antibody for myelofibrosis and essential thrombocythemia.
The company is also expecting pivotal data in mid-year for axatilimab for chronic GVHD.
Flannelly said, “We’re looking forward to another busy year in 2023.”
Christiana Stamoulis, Incyte’s Chief Financial Officer, provided 2023 financial guidance. The company is expecting Jakafi net product revenues of $2.53 to $2.63 billion (GAAP), with other hematology/oncology net product revenues of $215 to $225 million. Research and development expenses are expected to be $1.61 to $1.65 billion and selling, general and administrative expenses (SG&A) are projected to be $1.0 to $1.15 billion.
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Mark Terry is a freelance writer, editor, novelist and ghostwriter. He holds a degree in microbiology & public health and spent 18 years in infectious disease research and clinical and research genetics prior to his transition to a writing career. His areas of expertise include biotechnology, pharma, clinical diagnostics, and medical practice management. He has written literally thousands of articles, as well as market research reports, white papers, more than 20 books, and many other written materials. He currently lives in Michigan with his family.