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: Continued strong y/y revenue growth.

Basic data (GAAP):

Revenue was $1.05 billion, down 11% sequentially from $1.18 billion, and up 20% from $881 million in the year-earlier period.

Net income was $158 million, down 21% sequentially from $201 million, and down 7% from $170 million year-earlier.

Diluted EPS was $0.80, down 22% sequentially from $1.02, and up 7% from $0.75 year-earlier.

Guidance:

unchanged from Incyte Q4 2024 except slightly raised Jakafi net product revenue to $2.95 to $3.0 million.

Conference Highlights:

Hervé Hoppenot, Incyte CEO, said "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. 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." Niktimvo had a successful launch. Jakafi growth is being driven in the PV indication. Most Incyte products are made in both the U.S. and Europe, so hopes to minimize tariff price risk.

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. Expects 10 high-impact launches by 2030.

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. Two Phase 3 results for prurigo nodularis reported positve data in March 2025. A Phase 3 ruxolitinib cream for mild to moderate hidradenitis suppurativa will begin in 1H 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 February 2025, Incyte and Genesis Therapeutics entered a strategic collaboration focused on the research, discovery and development of novel small molecule medicines. The initial focus is on collaboration targets selected by Incyte. Incyte receives exclusive rights to develop and commercialize collaboration products leveraged through the GEMS AI platform.

Povorcitinib in April 2025 announced positve Phase 2 reults for CSU (chronic spontaneous urticaria). In March 2025 reported positive Phase 3 results for two studies for Hidradenitis Suppurativa. 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 $0.92 billion; royalties $130 million; milestone and contract revenue $0 million.

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

Non-GAAP numbers: Net income $229 million, down 19% sequentially from $281 million, and up 72% from $133 million year-earlier. Diluted EPS $1.16, down 19% sequentially from $1.43, and up 100% from $0.58 year-earlier.

Cash and equivalents ended at $2.4 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 $73 million. $437 million for research and development; $326 million for selling, general and administrative expenses; $0 million collaboration profit sharing; and a $12 million loss for change in value of a contingent consideration. Total costs $848 billion. Leaving income from operations of $205 million. Interest and other income was $21 million. Unrealized loss on investment was $1 million. Income taxes $76 million.

Q&A Selective Summary:

Jakafi PV growth color? Excecuting well on marketing, pushing to treat earlier. Good growth and continuation of therapy. New treatment option would be in combination therapies, Jak has a unique profile.

Povo for CSU line? Most patients fail early therapies. Will benefit from an oral, but some will try a biologic first, but the biologics also hava a high failure rate.

The monoclonal antibody (INCA033989) first data for ET and MF with CALR should come out in 2025.

IP and tariff? Key patent ownership is in U.S.

Capital allocation and BD? Mainly internal pipeline evolution. With 7 proof of concept events happening, we could need money for Phase 3 programs. We do continue to look at external research partnerships. No guidance on share repuchases.

6174F? Update this year, but a small number of patients.

We expect approval for rux XR by the middle of 2026.

Tafasitmab for CD19 follicular lymphoma? Pleased with data so far.

Niktimvo sales color? Pleased with launch. 70% of target accounts already using. Primarilly for 4th or later line patients. They are seeing rapid responses, which will encourage physicians to move to earlier lines of therapy. Also, there was some inventory build, about one-third, but about half of patients were on free drug.

Timeline on HS submission depends on talks with regulators.

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