Incyte Reports 2025 First Quarter Financial Results and Provides Updates on Key Clinical Programs

– Total revenues of $1,053 million in the first quarter (Q1'25) (+20% Y/Y); total product revenues of $922 million in Q1'25 (+26%Y/Y)

– Jakafi^® (ruxolitinib) net product revenues of $709 million in Q1'25 (+24% Y/Y); increasing full year 2025 Jakafi guidance to a new range of $2,950 - $3,000 million from $2,925 - $2,975 million

– Opzelura^® (ruxolitinib) cream net product revenues of $119 million in Q1'25 (+38% Y/Y)

– Niktimvo^™ (axatilimab-csfr) net product revenues of $14 million in the first two months of U.S. launch demonstrating strong commercial execution and high patient need

– New, 18-week data from ongoing Phase 3 study of povorcitinib in hidradenitis suppurativa (HS) demonstrates continued improvement in HiSCR from Week 12 in addition to high response rates in placebo-crossover patients

– Positive Phase 2 topline results for povorcitinib in chronic spontaneous urticaria (CSU) demonstrates proof-of-concept in new indication

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

WILMINGTON, Del.--(BUSINESS WIRE)--$INCY--Incyte (Nasdaq:INCY) today reports 2025 first quarter financial results, and provides a status update on the Company’s clinical development portfolio.

"The double-digit revenue growth in the first quarter driven by the continued growth of Jakafi and Opzelura and the recent launch of Niktimvo, puts us on track to achieve our full year objectives," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We also continued to advance our innovative pipeline, which will be critical for driving long-term growth. The positive Phase 3 results for povorcitinib in hidradenitis suppurativa in addition to the proof-of-concept in chronic spontaneous urticaria, strengthens the potential of povorcitinib as a multibillion-dollar product addressing patient needs across the five indications currently in development.”

Key Commercial Highlights

Jakafi^® (ruxolitinib):

Net product revenues for the first quarter 2025 of $709 million (+24% Y/Y):

• Net product revenue growth in the first quarter of 2025 versus the same quarter in the prior year, was driven by an increase in paid demand, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025.

Opzelura^® (ruxolitinib) cream:

Net product revenues for the first quarter 2025 of $119 million (+38% Y/Y):

• U.S. net product revenue of $95 million in the first quarter of 2025 increased 20% compared to the first quarter of 2024 driven by patient demand and refills in both atopic dermatitis (AD) and vitiligo, partially offset by a reduction in channel inventory. Opzelura inventory levels were within normal range at the end of the first quarter of 2025.
• Ex-U.S. net product revenues of $23 million in the first quarter of 2025 were primarily driven by continued growth in sales in Germany and France, as well as the recent launches in Italy and Spain.

Pipeline Updates

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

• The Phase 1 studies evaluating mutCALR in myelofibrosis (MF) and essential thrombocythemia (ET) and JAK2V617Fi in MF are enrolling patients. Initial proof of concept data for both studies are anticipated in 2025.
• A Phase 2 trial evaluating axatilimab (Niktimvo^™) in combination with ruxolitinib (Jakafi) in patients with newly diagnosed chronic GVHD is ongoing and enrolling patients.
• A Phase 3 trial evaluating axatilimab in combination with corticosteroids in patients with newly diagnosed chronic GVHD is ongoing and enrolling patients.

Other Hematology/Oncology – key highlights

• Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments.
• The Phase 3 study evaluating tafasitamab as first-line treatment for DLBCL is ongoing. The Phase 3 data are anticipated in the second half of 2025.
• The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in the second half of 2025.

Inflammation and Autoimmunity (IAI) – key highlights

Ruxolitinib Cream

• In March 2025, results from two Phase 3 studies (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in patients with prurigo nodularis (PN) were presented in a late-breaking oral session at the American Academy of Dermatology annual meeting. The TRuE-PN1 study met the primary endpoint of a > 4-point improvement from baseline in Worst-Itch Numeric Rating Scale (WI-NRS4) at Week 12 and all key secondary endpoints. The TRuE-PN2 study did not reach statistical significance for the primary endpoint, resulting in the key secondary endpoints with nominal p-values. These key secondary endpoints still demonstrate positive trends for ruxolitinib cream 1.5% versus vehicle. These data will inform planned discussions with regulatory authorities on submission.
• A Phase 3 trial for ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) is on track to initiate in the first half of 2025 following achieving alignment on the study design with FDA.

Povorcitinib (INCB54707)

• In April 2025, Incyte announced positive topline results from the Phase 2 study evaluating povorcitinib in patients with chronic spontaneous urticaria (CSU). The study met the primary endpoint at Week 12 of change from baseline in the Urticaria Activity Score summed over 7 days (UAS7). Povorcitinib was well tolerated with no new safety signals observed. These data will support planned discussions with regulatory agencies and will be presented at an upcoming medical conference.
• In March 2025, positive results from the Phase 3 studies (STOP-HS1 and STOP-HS2) of povorcitinib in patients with HS were presented and demonstrated that both studies met their primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 and at both tested doses (45mg and 75mg). In addition, at Week 12, patients treated with povorcitinib achieved deep levels of clinical response with a greater proportion achieving HiSCR75, reduction in flares, >3-point decrease in the Skin Pain Numeric Rating Scale (NRS) score and Skin Pain NRS30. Furthermore, povorcitinib demonstrated rapid onset of response, including rapid skin pain reduction. Additional longer-term data demonstrate that at Week 18, HiSCR rates continue to improve over Week 12 in patients treated with povorcitinib including high levels of response in those patients previously treated on placebo and crossed over to active povorcitinib treatment. These data support the planned regulatory submission of povorcitinib for the treatment of HS worldwide.
• Two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with PN versus placebo are ongoing and enrolling patients.
• A Phase 2 trial evaluating povorcitinib in asthma is ongoing and enrolling. Data are anticipated in the second half of 2025.

Other - key highlights

• In February 2025, Incyte and Genesis Therapeutics, Inc. (Genesis) entered into a strategic collaboration focused on the research, discovery and development of novel small molecule medicines, with an initial focus on collaboration targets selected by Incyte. Incyte receives exclusive rights to develop and commercialize collaboration products leveraged through Genesis’ GEMS artificial intelligence (AI) platform.

2025 First Quarter Financial Results

The financial measures presented in this press release for the three months ended March 31, 2025 and 2024 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.

Financial Highlights

Revenue Details

Product and Royalty Revenues Total net product and royalty revenues for the quarter ended March 31, 2025 increased 23% over the prior year comparative period. Total net product revenues for the quarter ended March 31, 2025 increased 26% over the prior year comparative period primarily driven by the following:

• Jakafi net product revenue increased 24% versus the prior year comparable period, driven by an increase in paid demand of 10% reflecting continued demand growth in all indications, the positive impact of the Part D redesign under the Inflation Reduction Act, partially offset by growth in 340B, and 7% favorable impact from less de-stocking compared to the first quarter of 2024. Jakafi inventory levels were within normal range at the end of the first quarter of 2025.
• Opzelura net product revenue increased 38% due to continued growth in new patient starts and refills in the U.S. with U.S. paid demand up 24% versus the first quarter of 2024, partially offset by a reduction in channel inventory, and increased contribution from ex-U.S. driven by continued uptake in Germany and France, as well as growth from the recent launches in Italy and Spain. Opzelura inventory levels were within normal range at the end of the first quarter of 2025.
• Minjuvi/Monjuvi net product revenue increased 24% as a result of the first quarter of 2025 reflecting three months of net product revenues in the U.S., compared to two months of net product revenue in the first quarter of 2024 due to the acquisition of U.S. rights to Monjuvi, which closed in February 2024.
• Niktimvo net product revenue driven by the commercial launch of the product during the first quarter of 2025.

Operating Expenses

Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended March 31, 2025 increased 20% and 22% respectively, compared to the same period in 2024 primarily due to increased royalty expense.

Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended March 31, 2025 increased 2% and 3%, respectively, compared to the same period in 2024, reflecting continued investment in our late stage development assets and timing of certain expenses.

Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2025 increased 8% and 9%, respectively, compared to the same period in 2024 primarily due to timing of consumer marketing activities and of certain other expenses.

Other Financial Information

Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended March 31, 2025, compared to the same period in 2024, was primarily due to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig.

Operating income GAAP and Non-GAAP operating income for the three months ended March 31, 2025 increased 123% and 76%, respectively, compared to the same period in 2024, driven primarily by growth in net product revenue.

Cash, cash equivalents and marketable securities position As of March 31, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.4 billion and $2.2 billion, respectively.

2025 Financial Guidance

Incyte's guidance for the fiscal year 2025 is summarized below. Incyte is raising its full year 2025 Jakafi revenue guidance. Guidance for Opzelura includes net product revenue for pediatric atopic dermatitis which has an anticipated approval in the second half of 2025. Guidance for other oncology net product revenues include net product revenue for Monjuvi in follicular lymphoma and Zynyz in squamous cell anal carcinoma. Approvals for these indications are anticipated in the second half of 2025. Guidance for research and development excludes the $15 million of expense for the full year 2025 related to our recently announced collaboration with Genesis.

Conference Call and Webcast Information

Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13753168.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13753168.

The conference call will also be webcast live and can be accessed at investor.incyte.com.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

About Jakafi^® (ruxolitinib)

Jakafi^® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is a registered trademark of Incyte.

About Opzelura^® (ruxolitinib) Cream

Opzelura^® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Opzelura and the Opzelura logo are registered trademarks of Incyte.

About Monjuvi^® (tafasitamab-cxix)

Monjuvi^® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

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