Analyst Conference Summary

biotechnology

conference date: February 10, 2025 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2024 (Q4, fourth quarter 2024)

Forward-looking statements

Overview: Excellent revenue increase of 16% y/y, but keep in mind Jakafi patent expires end of 2028.

Basic data (GAAP):

Revenue was $1.18 billion, up 4% sequentially from $1.14 billion, and up 17% from $1.01 million in the year-earlier period.

Net income was $201 million, up 90% sequentially from $106 million, and about flat from $201 million year-earlier.

Diluted EPS was $1.02, up 85% sequentially from $0.55, and up 15% from $0.89 year-earlier.

Guidance:

Jakafi product revenue $2.93 to $2.98 billion. Opzelura $630 to $670 million. Other oncology revenud $415 to $455 million. Non-GAAP: cost of revenue 7.5% to 8.0% of those revenues. R&D $1.78 tp $1.81 billion. SG&A $1.16 to $1.19 billion.

Conference Highlights:

Hervé Hoppenot, Incyte CEO, said "2024 was an important year for Incyte, with a 15% increase in total revenues, driven by strong growth from both Jakafi and Opzelura, as well as significant progress across our R&D pipeline. Looking ahead to 2025, we anticipate a year of continued strong revenue growth and diversification, as well as several defining milestones that will serve as an inflection point for Incyte. A year ago, we set the goal to achieve more than 10 impactful product launches by 2030. In 2025, a number of key catalysts across the entire portfolio will bring that goal closer to reality."

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 $1.02 billion; royalties $159 million; milestone and contract revenue $0 million.

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

Non-GAAP numbers: Net income $281 million, up 34% sequentially from $210 million, and up 18% from $239 million year-earlier. Diluted EPS $1.43, up 34% sequentially from $1.07, and up 35% from $1.06 year-earlier.

Cash and equivalents ended at $2.2 billion, up sequentially from $1.8 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 $88 million. $466 million for research and development; $327 million for selling, general and administrative expenses; $0 million collaboration profit sharing; and a $4 million gain for change in value of a contingent consideration. Total costs $877 billion. Leaving income from operations of $302 million. Interest and other income was $21 million. Unrealized loss on investment was $10 million. Income taxes $113 million.

Q&A Selective Summary:

Opzelura cream in PN clinical bar? We expect Phase 3 data this half. If we are in the vicinity of the Phase 2 data we think that will be good. Rux cream is very well tolerated.

CDK2 clinical trials should start this year. Update later this year.

Opzelura guidance on tubes? It is up 24% to 32%, includes pediatric launch, increased contribution from Europe. Based on patient activation rates, including tubes for Vitilago. Increasing numbers of patients are seeking therapy. We plan additional initiatives to drive further growth. But Q1 tends to dip from Q4.

IRA out of pocket rule? Is reduced to $2,000 per year. Patients can have this spread through the year, but we may not see that right away.

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