Incyte Reports Q4 and Year-End 2024 Results, Provides 2025 Financial Outlook and R&D Milestones
Incyte (Nasdaq: INCY) has announced its financial results for the fourth quarter and full year ended December 31, 2024, along with its financial guidance for 2025.
Incyte’s performance in 2024 marked a significant milestone, with a 15% increase in overall revenue. This growth was driven by strong performances from Jakafi and Opzelura, in addition to notable advancements in their research and development pipeline. Hervé Hoppenot, the CEO of Incyte, highlighted, “Looking ahead to 2025, we expect continued robust revenue growth and greater diversification, along with several pivotal milestones that will shape the future of Incyte. Last year, we set a goal of achieving over 10 impactful product launches by 2030. In 2025, key catalysts across our portfolio will bring us closer to this goal.”
2025: Key Catalysts Ahead
Incyte aims to achieve at least 18 significant milestones in 2025, including:
- Four New Product Launches:
- Niktimvo™ for 3L+ chronic graft-versus-host disease (GVHD)
- Ruxolitinib cream for pediatric atopic dermatitis (AD)
- Tafasitamab for relapsed/refractory follicular lymphoma (FL)
- Retifanlimab for squamous cell anal carcinoma (SCAC)
- At Least Three Phase 3 Study Initiations:
- BET inhibitor for 2L myelofibrosis (MF)
- Ruxolitinib cream for mild to moderate hidradenitis suppurativa (HS)
- CDK2 inhibitor for ovarian cancer
- Four Pivotal Readouts:
- Povorcitinib for moderate to severe HS
- Ruxolitinib cream for prurigo nodularis (PN)
- Tafasitamab for 1L diffuse large B-cell lymphoma (DLBCL)
- Ruxolitinib XR for MF, polycythemia vera (PV), and GVHD
- Seven Proof of Concept Readouts:
- Povorcitinib for chronic spontaneous urticaria (CSU) and asthma
- MutCALR for MF and essential thrombocythemia (ET)
- JAK2V617F mutant-specific inhibitor for MF
- KRASG12D and TGFβR2xPD-1 for solid tumors
Key Company Developments
- Ruxolitinib Extended-Release (XR): A bioequivalence study has been completed, with results expected to be submitted to the U.S. FDA by the end of 2025 after stability studies are finalized.
- Niktimvo™ Approval: In January 2025, Incyte and Syndax Pharmaceuticals announced the FDA approval of Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes, with the U.S. launch underway.
- Tafasitamab in FL: In December 2024, pivotal results from the inMIND trial were presented at the ASH Annual Meeting, showing that tafasitamab in combination with lenalidomide and rituximab improved progression-free survival in relapsed or refractory FL patients. FDA approval for this indication is expected in the second half of 2025.
- BET Inhibitor (INCB057643): Data from the 2024 ASH Annual Meeting showed that treatment with INCB057643 in myelofibrosis (MF) was well-tolerated, with notable improvements in anemia, spleen size, and symptom burden. A Phase 3 monotherapy study is planned for 2025.
- Retifanlimab (Zynyz®): The supplemental Biologics License Application (sBLA) for retifanlimab in advanced squamous cell anal carcinoma was submitted to the FDA, with approval expected in the second half of 2025.
- Ruxolitinib Cream (Opzelura®): A supplemental new drug application (sNDA) for ruxolitinib cream in pediatric atopic dermatitis was filed with the FDA, and approval is expected by late 2025.
Jakafi and Opzelura Performance
- Jakafi:
- Q4 2024 net product revenues reached $773 million, with 2024 total revenues of $2.79 billion.
- This reflects an 11% increase in Q4 compared to Q4 2023 and an 8% increase for the full year, driven by a 14% increase in paid demand in Q4 and a 9% increase for 2024 overall, across all indications.
- Opzelura:
- Q4 2024 net product revenues totaled $162 million, with full-year 2024 revenues of $508 million.
- This represents a 48% increase in Q4 and a 50% increase for the full year, driven by strong demand in atopic dermatitis and vitiligo, along with growing contributions from Europe.
Pipeline Updates
- Myeloproliferative Neoplasms (MPNs) and GVHD:
- Ongoing Phase 1 studies for mutCALR in MF and essential thrombocythemia, as well as JAK2V617Fi in MF, with initial proof of concept data expected in 2025.
- A Phase 2 trial of axatilimab in combination with ruxolitinib for newly diagnosed chronic GVHD is underway.
- Hematology/Oncology:
- Incyte plans to initiate Phase 3 studies for its CDK2 inhibitor (INCB123667) in ovarian cancer in 2025 and is exploring its use in combination therapies.
- The Phase 3 study for tafasitamab in first-line DLBCL is ongoing, with results expected in the first half of 2025.
- Inflammation and Autoimmunity (IAI):
- Two Phase 3 trials of ruxolitinib cream in prurigo nodularis (PN) are fully enrolled, with data anticipated in 2025.
- Phase 3 trials for povorcitinib in HS and PN are also underway, with data for HS expected in the first half of 2025.
- Regulatory Approvals:
- Opzelura was granted approval by the Swiss Agency for Therapeutic Products for treating non-segmental vitiligo with facial involvement in February 2025.
- In October 2024, Opzelura received approval in Canada for treating both mild to moderate atopic dermatitis and vitiligo in patients 12 and older.
Other Programs
- Zilurgisertib (ALK2) for fibrodysplasia ossificans progressiva: The Phase 2 pivotal trial is ongoing.
With these milestones on the horizon, Incyte is poised for a transformative year in 2025.
2024 Fourth Quarter and Year-End Financial Results
The financial results presented in this release for the quarter and year ending December 31, 2024, and 2023 have been prepared according to U.S. Generally Accepted Accounting Principles (GAAP), unless specified as Non-GAAP financial measures. Management believes that Non-GAAP information is valuable for investors, especially when considered alongside Incyte’s GAAP disclosures. These Non-GAAP metrics help guide internal budgeting, financial planning, and performance monitoring. The Company adjusts certain expenses to better reflect its core operations, providing investors with an enhanced understanding of financial performance. These metrics align with industry peers’ disclosures.
It is important to note that Non-GAAP information is not based on a comprehensive set of accounting rules and should be used alongside, rather than as a replacement for, GAAP results. Different companies may define and calculate Non-GAAP measures in various ways.
Since exchange rate fluctuations can significantly impact period-to-period comparisons, the Company presents certain revenue results on a constant currency basis, in addition to reported figures. Constant currency figures adjust for foreign exchange impact by recalculating current-year results using the prior year’s exchange rates. These results are supplementary and not a substitute for GAAP figures, and may differ from similarly titled measures used by other companies.
Financial Highlights
(Unaudited, in thousands, except per share amounts)
| Three Months Ended December 31 | 2024 | 2023 | % Change (GAAP) |
|---|---|---|---|
| Total GAAP Revenues | $1,178,698 | $1,013,341 | 16% |
| Total GAAP Operating Income | $301,513 | $187,270 | 61% |
| Total Non-GAAP Operating Income | $376,265 | $267,702 | 40% |
| GAAP Net Income | $201,212 | $201,079 | 0% |
| Non-GAAP Net Income | $281,353 | $239,124 | 18% |
| GAAP Basic EPS | $1.04 | $0.90 | 16% |
| Non-GAAP Basic EPS | $1.46 | $1.07 | 36% |
| GAAP Diluted EPS | $1.02 | $0.89 | 15% |
| Non-GAAP Diluted EPS | $1.43 | $1.06 | 35% |
| Twelve Months Ended December 31 | 2024 | 2023 | % Change (GAAP) |
|---|---|---|---|
| Total GAAP Revenues | $4,241,217 | $3,695,649 | 15% |
| Total GAAP Operating Income | $61,366 | $620,525 | -90% |
| Total Non-GAAP Operating Income | $413,883 | $892,783 | -53% |
| GAAP Net Income | $32,615 | $597,599 | -95% |
| Non-GAAP Net Income | $227,591 | $795,449 | -71% |
| GAAP Basic EPS | $0.16 | $2.67 | -94% |
| Non-GAAP Basic EPS | $1.10 | $3.56 | -69% |
| GAAP Diluted EPS | $0.15 | $2.65 | -94% |
| Non-GAAP Diluted EPS | $1.08 | $3.52 | -69% |
Revenue Breakdown
(Unaudited, in thousands)
| Three Months Ended December 31 | 2024 | 2023 | % Change (as reported) | % Change (constant currency) |
|---|---|---|---|---|
| Net Product Revenues: | ||||
| Jakafi | $773,114 | $695,127 | 11% | 11% |
| Opzelura | $161,602 | $109,243 | 48% | 48% |
| Iclusig | $27,369 | $27,130 | 1% | 1% |
| Pemazyre | $23,142 | $20,653 | 12% | 12% |
| Minjuvi/Monjuvi | $32,807 | $8,994 | 265% | 265% |
| Zynyz | $1,373 | $582 | 136% | 136% |
| Total Net Product Revenues | $1,019,407 | $861,729 | 18% | 18% |
| Royalty Revenues: | | | | | | Jakavi | $114,187 | $103,892 | 10% | 13% | | Olumiant | $38,485 | $40,359 | -5% | -3% | | Tabrecta | $6,286 | $4,678 | 34% | NA | | Pemazyre | $333 | $683 | NM | NM | | Total Royalty Revenues | $159,291 | $149,612 | 6% | — | | Total Net Product and Royalty Revenues | $1,178,698 | $1,011,341 | 17% | 16% | | Milestone and Contract Revenues | $0 | $2,000 | NM | NM | | Total GAAP Revenues | $1,178,698 | $1,013,341 | 16% | 15% |
Key Product and Royalty Revenue Highlights
For the quarter and year ended December 31, 2024, total net product and royalty revenues increased by 17% and 14%, respectively, compared to the prior year, mainly driven by:
- Jakafi: Net product revenue grew 11% in Q4 and 8% for the full year, with a 14% increase in paid demand for the quarter. For the year, the growth was primarily driven by a 9% increase in paid demand.
- Opzelura: Net product revenue surged 48% in Q4 and 50% for the year, driven by new patient starts, refills in the U.S., and increased contributions from Europe.
- Minjuvi/Monjuvi: Net product revenue grew significantly by 265% for the quarter and 222% for the year, following the acquisition of exclusive global rights to tafasitamab in February 2024.
- Royalty Revenues: Overall, royalty revenues rose by 6% in Q4 and 11% for the full year, with Jakavi royalties contributing to the growth.
Operating Expenses Overview
(Unaudited, in thousands)
| Three Months Ended December 31 | 2024 | 2023 | % Change (GAAP) |
|---|---|---|---|
| GAAP Cost of Product Revenues | $88,485 | $69,751 | 27% |
| Non-GAAP Cost of Product Revenues | $82,427 | $63,575 | 30% |
| GAAP R&D Expenses | $466,034 | $444,494 | 5% |
| Non-GAAP R&D Expenses | $420,297 | $408,488 | 3% |
| GAAP SG&A Expenses | $326,710 | $293,865 | 11% |
| Non-GAAP SG&A Expenses | $299,709 | $270,673 | 11% |
Conclusion
Incyte’s financial performance for Q4 and the year ended December 31, 2024, demonstrates growth across key areas, particularly driven by the strong performance of Jakafi, Opzelura, and Minjuvi/Monjuvi. The increase in total net product and royalty revenues reflects ongoing strategic initiatives, while expenses for R&D and SG&A have grown in line with the company’s expansion. The company continues to focus on its core operations and maintaining a strong position in the market.
