Incyte Raises Sales Outlook as Drug Revenue Climbs 14%

Incyte

WILMINGTON, DE — Incyte Corp. (Nasdaq: INCY) raised its full-year 2026 sales forecast after reporting a 14% increase in third-quarter revenue to $1.56 billion, as growth in its dermatology and oncology businesses continued to reduce the company’s dependence on its flagship blood cancer treatment, Jakafi.

The Wilmington-based pharmaceutical company reported $1.32 billion in product sales for the quarter ended Sept. 30, also up 14% from a year earlier. Sales of Opzelura increased 36%, while its hematology and oncology portfolio grew 38%.

Incyte increased its full-year product sales guidance to between $5.21 billion and $5.30 billion, reflecting stronger demand across its marketed treatments.

The revised forecast includes expected annual Opzelura sales of $1.10 billion to $1.12 billion and hematology and oncology sales of $890 million to $910 million. The company maintained its previous guidance for other financial categories.

The results underscore a shift in Incyte’s revenue mix as the company expands its commercial portfolio and invests in treatments intended to support growth beyond Jakafi.

Jakafi and Jakafi XR generated $827 million in third-quarter sales, a 4% increase from the comparable period in 2025. Incyte attributed the increase primarily to a 12% rise in paid demand across the treatments’ approved indications.

Opzelura, a topical treatment used for certain inflammatory skin conditions, generated $255 million in sales. Growth reflected increased patient demand for atopic dermatitis and vitiligo treatments, along with improved net pricing following a settlement involving an Opzelura line extension in the second quarter.

The company’s hematology and oncology portfolio recorded $235 million in sales, supported by increased demand for Niktimvo, Zynyz and Monjuvi/Minjuvi.

Together, Opzelura and the hematology and oncology portfolio generated $490 million in quarterly sales, compared with $827 million for Jakafi and Jakafi XR.

The commercial gains coincided with a sharp increase in reported research spending following Incyte’s acquisition of Vega Therapeutics in July.

Research and development expenses reached $1.79 billion under generally accepted accounting principles, compared with a substantially lower level a year earlier. The 254% increase was driven primarily by a one-time $1.23 billion acquired research and development charge associated with the transaction.

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Excluding the Vega-related charge, research and development expenses increased 11%, reflecting additional investment in late-stage clinical programs.

Incyte acquired Vega Therapeutics, a subsidiary of Star Therapeutics, for $1.25 billion, adding the investigational blood disorder treatment latarcibart to its development pipeline. The agreement also provides for up to $750 million in additional payments tied to sales milestones.

The acquisition contributed to a 260% decline in GAAP operating income compared with the prior-year quarter. Excluding the acquisition’s upfront consideration, GAAP operating income increased 18%, supported by higher revenue.

Non-GAAP operating income declined 226% on a year-over-year basis.

Selling, general and administrative expenses increased 11% to $364.3 million under GAAP, primarily reflecting activities associated with preparations for potential product launches.

Cost of sales totaled $108.7 million under GAAP and $102.2 million on a non-GAAP basis, representing approximately 8% of product sales.

Incyte ended September with $3.9 billion in cash, cash equivalents and marketable securities, compared with $3.6 billion at the end of 2025.

Chief Executive Officer Bill Meury identified growth outside Jakafi and the company’s expanding clinical pipeline as central to its longer-term strategy.

“Net sales growth was strong in both the U.S. and internationally, creating a durable core business beyond Jakafi,” Meury stated.

The company is pursuing several late-stage development programs across blood disorders, gastrointestinal cancers and inflammatory diseases, with multiple regulatory decisions and clinical trial results expected through 2027.

In hematology, Incyte is advancing INCA033989, an investigational antibody targeting mutated calreticulin, or CALR, in certain blood disorders.

A Phase 3 trial involving patients with CALR-mutated essential thrombocythemia who are resistant or intolerant to previous treatment began in mid-2026.

A separate Phase 3 trial in patients with myelofibrosis previously treated with a JAK inhibitor is expected to begin by the end of 2026 following discussions with the U.S. Food and Drug Administration.

Additional early-stage data involving INCA033989, both alone and in combination with ruxolitinib, are expected during the fourth quarter.

Incyte is also conducting a Phase 3 study of latarcibart for von Willebrand disease, an inherited bleeding disorder. The VIVID-6 trial is evaluating monthly injections to prevent bleeding, with initial results anticipated in early 2029.

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The company expects a potential U.S. approval and commercial launch of Monjuvi for newly diagnosed diffuse large B-cell lymphoma during the first quarter of 2027, subject to regulatory review.

Clinical results involving Niktimvo in combination with ruxolitinib for newly diagnosed chronic graft-versus-host disease are expected to be presented at a medical meeting in the first quarter of 2027.

In oncology, Incyte is expanding development of INCB161734, an investigational KRAS G12D inhibitor being studied in pancreatic and colorectal cancers.

Early clinical findings presented at the 2026 European Society for Medical Oncology Congress showed antitumor activity when the treatment was combined with standard chemotherapy in patients with metastatic pancreatic cancer.

A Phase 3 trial evaluating the combination as an initial treatment for metastatic pancreatic cancer is underway, with results expected in 2028.

Incyte plans to begin another Phase 3 study in 2027 evaluating the treatment following surgical removal of pancreatic tumors.

The company is also preparing a Phase 3 trial combining INCB161734 with cetuximab in previously treated colorectal cancer, with enrollment expected to begin during the first half of 2027.

Another investigational treatment, INCA33890, is being evaluated in combination with chemotherapy and bevacizumab for microsatellite-stable colorectal cancer.

Early trial findings presented at the oncology congress supported continued development, including an ongoing Phase 3 study with results anticipated in 2029.

In October, Incyte began a Phase 2 study of INCA33890 in patients with stage II or III colorectal cancer who have completed surgery and chemotherapy but continue to show circulating tumor DNA associated with residual disease.

The company also redirected development of INCB123667, an investigational CDK2 inhibitor, toward maintenance treatment for ovarian cancer.

Enrollment in a Phase 3 trial involving platinum-resistant ovarian cancer was discontinued as Incyte shifted its focus to earlier treatment settings.

A new Phase 3 study combining INCB123667 with bevacizumab as first-line maintenance therapy was scheduled to begin in the fourth quarter.

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In dermatology, Incyte is approaching several regulatory and clinical milestones that could expand the markets for Opzelura and povorcitinib.

The European Commission approved Opzelura in July for adults with moderate atopic dermatitis who cannot adequately use certain other topical treatments. The decision established a second approved indication for the drug in the European Union.

Phase 3 results evaluating ruxolitinib cream for mild to moderate hidradenitis suppurativa, a chronic inflammatory skin condition, are expected during the fourth quarter.

Incyte is also awaiting regulatory decisions involving povorcitinib, an investigational oral treatment for moderate to severe hidradenitis suppurativa.

European regulators issued a positive recommendation in September for patients who have not responded adequately to, cannot tolerate or cannot receive anti-TNF therapy.

A European Commission decision was expected during the fourth quarter, while a potential U.S. approval and launch could occur in the first quarter of 2027.

Additional Phase 3 data for povorcitinib in prurigo nodularis, a chronic inflammatory skin disease, are expected before year-end. Incyte also anticipates preliminary Phase 2 results involving the treatment in asthma.

Beyond its development programs, Incyte reached an agreement with the Centers for Medicare & Medicaid Services in August concerning pricing and access to Jakafi and Jakafi XR.

Under the agreement, state Medicaid programs will be able to obtain the treatments at prices aligned with those in a specified group of other advanced industrialized countries.

Incyte also expects the arrangement to exempt it from certain proposed future CMS pricing requirements, including the GUARD and GLOBE models.

The agreement introduces another element into the company’s financial outlook as federal drug-pricing policies increasingly influence pharmaceutical manufacturers’ commercial strategies.

Incyte’s stronger product sales and higher annual guidance provide additional revenue momentum as the company absorbs acquisition-related expenses and advances clinical programs that could determine its growth trajectory later in the decade.

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