Analyst Conference Summary

biotechnology

conference date: July 29, 2025 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2025 (Q2, second quarter 2025)

Forward-looking statements

Overview: Strong quarter with Opzelura cream revenue up 35% y/y. Also boosted by a positive $242 million contract dispute settlement.

Basic data (GAAP):

Revenue was $1.22 billion, up 16% sequentially from $1.05 billion, and up 16% from $1.04 billion in the year-earlier period.

Net income was $405 million, up 156% sequentially from $158 million, and up from negative $445 million year-earlier.

Diluted EPS was $2.04, up 155% sequentially from $0.80, and up from negative $2.04 year-earlier.

Guidance:

Raised revenue guidance for 2025, with Jakafi at $3.0 to $3.05 billion, Opzelura $630 to $670 million, other products $500 to $520 million. R and D expense also raised slightly.

Conference Highlights:

Bill Meury, Incyte CEO, said "As I begin my tenure as CEO, I look forward to leading Incyte through its next phase of growth and value creation for patients, partners and shareholders. Our second quarter results reflect strong growth for Jakafi (ruxolitinib), Opzelura (ruxolitinib) cream and Niktimvo (axatilimab), positioning us well to deliver on our 2025 objectives. During the quarter, we achieved two regulatory milestones with the approvals of Zynyz (retifanlimab-dlwr) for squamous cell anal carcinoma and Monjuvi (tafasitamab-cxix) for follicular lymphoma, further expanding our ability to address patients' needs. Continued progress and diversification of our portfolio, including advancements with povorcitinib and mutCALR, are strengthening the foundation for sustainable, long-term growth." Believes Incyte has high potential for growth with new products and indications. Building a comprehensive plan for acceleration of product flow. 989 is very promissing. Has cash for both internal development and possible external adds.

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.

In Q2 2025 Zynzyz and Monjuvi got FDA approval for first-line for advanced squamous cell carcinoma of the anal canal and (combined with rituximab) for relapsed follicular lymphoma and (combined with lenalidomide) for refractory follicular lympohoma.

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 June 2025 positive Phase 1 data for INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) were presented. Believes 989 offers a potential path to a cure. Hopes to initiate pivotal trial in ET by 2026. A diagnostic is being developed.

Incyte Phase 3 studies for its CDK2 inhibitor (INCB123667) for ovarian cancer in planned to start in 2025. It is also evaluating INCB123667 in combination with other treatments.

Phase 3 data for tafasitamab for DLBCL is expected in 2H 2025.

In Q2 2025 positive topline results from the Phase 3 trial of rux cream with moderate atopic dermatitis were reported. More trials are ongoing. But the application for 2 to 11 year olds had its PDUFA date extended 3 months to September 19, 2025.

Believes can deliver 10 new launches by 2030.

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 $312 million, up 36% sequentially from $229 million, and up from negative $396 million year-earlier. Diluted EPS $1.57, up 35% sequentially from $1.16, and up from negative $1.82 year-earlier.

Cash and equivalents ended at $2.4 billion, flat sequentially from $2.4 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 79$ million. $495 million for research and development; $331 million for selling, general and administrative expenses; $0 million collaboration profit sharing; $23 million loss for change in value of a contingent consideration; offset by a positive $242 million contract dispute settlement. Total costs $685 million. Leaving income from operations of $530 million. Interest and other income was $24 million. Unrealized loss on investment was $4 million. Income taxes $153 million.

Q&A Selective Summary:

Relative importance of therapeutic areas? MPN is our most important therapeutic area. We have an asymetrical advantage in that group of blood cancers. Could have a series of inovations starting with 989. We have a credible path in I and I. We have a strategy for solid tumors.

EP data color, expectations? Mechanistically 989 would work the same way as ET, so the data could transfer to other diseases with same molecular bases. Combination with Rux for MF is a likely to show improvements.

617F initial data delay? Dose escalation, delay is due to needing a higher dose for effectiveness. Data in first half of 2026. Conviction on the mechanism is strong.

Povo competitive differentiation? On HS, it is one of the most challenging conditions in dermatology. It is inflamation soup with multiple pathways. Povo has competitive data on pain and flare control.

Niktimvo sales? Five months in, 10% penetration of 3rd - 4th line market. Could reach 1000 patients by end of year.

989? We must have single agent activity in MF. But also want to address various lines, including those who failed Jakofi. We expect single agent activity in MF.

Niktimvo peak opportunity? Reassured by what we have seen so far. But need to get it into combinations with Jakafi and steroids, also sub-q formulation, which all depend on ongoing development.

Monjuvi FL approval impact? Showed reduced risk v. standard of care. Expectations are in current guidance. Sees $200 million annual revenue by 2028.

Timeline on HS submission depends on talks with regulators.

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