Analyst Conference Summary

biotechnology

conference date: April 29, 2025 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2025 (Q1, first quarter 2025)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $ billion, up % sequentially from $1.18 billion, and up % from $ million in the year-earlier period.

Net income was $ million, up % sequentially from $201 million, and about flat from $ million year-earlier.

Diluted EPS was $, up % sequentially from $1.02, and up % from $ year-earlier.

Guidance:

Conference Highlights:

Hervé Hoppenot, Incyte CEO, said ""

Ruxolitinib extended-release (XR) met the bioequivalence criteria set by the FDA. Data anticipated to be submitted to the FDA by year-end 2025.

Incyte expects 18 key milestones in 2025. Four new product launches, three Phase 3 initiations, four pivotal readouts, and seven proof of concept data readouts.

In January 2025 the FDA approved Niktimvo 9mg and 22 mg vials. In Q3 2024 Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, got FDA approval for chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. With Syndax Pharmaceuticals.

In Q3 2024 Incyte submitted an sNDA for ruxolitinib cream for pediatric atopic dermatitis. Expects approval in 2H 2025. Phase 3 results for prurigo nodularis is expected in 2025.

Zynyz (retifanlimab) Phase 3 data for squamous cell anal carcinoma was positive. Plans to file an sNDA in Q4 2024. Also had positive results in Phase 3 NSCLC trial, with full data to be presented in Q4 2024.

In Q4 2024 announced full, positive results from Phase 3 Monjuvi trial in follicular lymphoma at ASH. sNDA submitted Q4 2024 with approval possible in 2H 2025.

In December 2024 Zynyz sBLA filed for squamous cell anal carcinoma; could get approve in 2H 2025.

In October 2024, sNDA submitted for ruxolitinib cream (Opzelura) in pediatric atopic dermatitis, with approval anticipated in the second half of 2025.

Povorcitinib is in studies for hidradenitis suppurativa, vitiligo, prurigo nodularis, chronic spontaneous urticaria, and moderate/sever asthma, with some data readouts in 2025.

INCB000262 (MRGPRX2)is in Phase 2 trials for CSU, chronic inducible urticaria, and atopic dermatitis. Data for the trials is due in Q1 2025.

Jakafi patent protection now expected to expire towards the end of 2028. But Opzelura protected until 2040.

Product revenue was $ billion; royalties $ million; milestone and contract revenue $0 million.

Jakafi royalty revenue is from sales by Novartis outside the U.S.

Non-GAAP numbers: Net income $ million, up % sequentially from $281 million, and up % from $ million year-earlier. Diluted EPS $, up % sequentially from $1.43, and up % from $ year-earlier.

Cash and equivalents ended at $ billion, up sequentially from $2.2 billion. No debt.

Incyte has numerous other trials in multiple therapies and indications underway, plus preclinical agents.

See also Incyte pipeline.

GAAP operating expenses were: cost of product revenue $ million. $ million for research and development; $ million for selling, general and administrative expenses; $0 million collaboration profit sharing; and a $ million gain for change in value of a contingent consideration. Total costs $ billion. Leaving income from operations of $ million. Interest and other income was $ million. Unrealized loss on investment was $ million. Income taxes $ million.

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