Analyst Conference Summary

biotechnology

conference date: October 28, 2025 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2025 (Q3, third quarter 2025)

Forward-looking statements

Overview: Strong y/y revenue growth, but still highly dependent on Jakafi, with generics looming.

Basic data (GAAP):

Revenue was $1.37 billion, up 12% sequentially from $1.22 billion, and up 20% from $1.14 billion in the year-earlier period.

Net income was $424 million, up 5% sequentially from $405 million, and up 300% from $106 million year-earlier.

Diluted EPS was $2.11, up 3% sequentially from $2.04, and up 291% from $0.54 year-earlier.

Guidance:

Raised full year product revenue guidance to $4.23 to $4.32 billion.

Conference Highlights:

Bill Meury, Incyte CEO, said "Our third-quarter results demonstrate strong growth across our product portfolio, with net product revenues increasing 19% year-over-year, which highlights the momentum in our business and effective commercial execution. We are taking a deliberate approach to pipeline prioritization. We are actively reviewing our R&D efforts and focusing on high-value programs that are scientifically differentiated, address unmet medical needs, and have the potential to significantly drive Incyte’s next phase of growth." Maintaining market share with Jakafi. WM: Keep in mind Jakafi patent exclusivity is expected to expire in the U.S. in 2028, though that might be extended by court challenges, and Incyte will try to shift patients to the XR version.

Ruxolitinib extended-release (XR) bioequivalence data to be submitted to the FDA in Q4 2025.

In Q4 2025 Phase 1 results for INCA33890, a TGFBR2xPD-1 bispecific antibody showed clinical efficacy across multiple tumors, including microsatellite stable colorectal cancer (MSS CRC) with and without active liver metastases. Will initiate a registrational program evaluating INCA33890 in MSS CRC in 2026.

In Q4 2025 preliminary positive Phase 1 results were reported for INCB161734, a KRASG12D selective inhibitor, in heavily pretreated pancreatic ductal adenocarcinoma (PDAC) patients with a KRASG12D mutation.

In Q3 2025 the FDA approved Opzelura for pediatric atopic dermatitis. In October 2025 presented positive Phase 3 results for moderate atopic dermatitis. The EU filing for rux cream for AD is expected by year-end 2025.

Niktimvo for graft-v-host disease continues to grow rapidly, mostly in fourth line setting.

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. Regulatory submissions for povorcitinib in moderate to severe HS in the EU and the U.S. are anticipated by year end 2025 and early 2026, respectively. 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. The Phase 3 study evaluating (tafasitamab) Monjuvi for first-line diffuse large B-cell lymphoma (DLBCL) has data anticipated around year-end 2025.

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.

Novel biological pathways are the cornerstone of Incyte's cancer program. 3 programs are in early development. However, as of Q4 2025 decided to halt or suspend several programs: 33460, 57643, and povorcitinib for chronic spontaneous uticaria.

Looking for business development opportunities; hired a new leader for that. Doing a strategic review.

Jakafi patent protection now expected to expire towards the end of 2028. But Opzelura protected until 2040. And will try to move Jakafi patients to Jakafi XR.

Product revenue was $1.15 billion; royalties $171 million; milestone and contract revenue $45 million.

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

Non-GAAP numbers: Net income $498 million, up 60% sequentially from $312 million, and up 95% from $255 million year-earlier. Diluted EPS $2.26, up 44% sequentially from $1.57, and up 111% from $1.07 year-earlier.

Cash and equivalents ended at $2.9 billion, up 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 $99 million. $507 million for research and development; $329 million for selling, general and administrative expenses; $0 million collaboration profit sharing; $12 million loss for change in value of a contingent consideration. Total costs $922 million. Leaving income from operations of $444 million. Interest and other income was $26 million. Gain on investment was $9 million. Income taxes $58 million.

Q&A Selective Summary:

Upcoming mutcalr data? Standalone efficacy? Mutant calr antibody program, INCA033989 for MF and ET with CALR mutation. ASH update will include 50 patients on monotherapy. Will include translational endpoints.

Termination of povo for CSU program despite earlier positive Phase 2 results? Factors were competition, timing to market, differentiation, and market potential. Also regulatory bar in CSU set by FDA is high, so we decided to prioritize other programs. Will likely release data at a later date.

Niktimvo, failed Sanofi trial implications? There is controversy around GVHD in first line setting combined with steroids. Sanofi trial shows how hard it is to beat steroids. We are confident in our program.

BET inhibor program termination? Risk benefit calculus is complex. Not a clear enough path to market.

989 could create a long revenue and cash glow stream well into the next decade. Current ET therapy, hydroxyuria has residual symptoms. 989 should be much better. Is a $5 billion annual market. In MF would add to Jakafi or use it when patients progress from Jakafi, which they all do.

Reducing expenses is based on prioritizing the pipeline for long term growth.

For pipeline, we have 7 drivers that could create meaningful value. Not all of them have to work, does not expect all to work.

Enable, XR partnership? We like the device. They are a high-quality company. Expect to launch in mid-2026. Expecting 15 to 30% conversion. Expect slower erosion over time after loss of exclusivity. We are currently not working on using XR in combinations.

OpenIcon Analyst Conference Summaries Main Page

Incyte at Openicon

Search

More Analyst Conference Pages: