Incyte Releases Q2 2024 Financials and Key Clinical Updates

In the second quarter of 2024, Incyte reported a 9% increase in total revenues year-over-year, surpassing $1.0 billion for the quarter. The commercial performance was notably driven by strong patient demand for Opzelura® (ruxolitinib) and growth in all indications for Jakafi® (ruxolitinib). Hervé Hoppenot, Chief Executive Officer of Incyte, highlighted the strategic intensification on their clinical programs, reflecting confidence in their commercial portfolio and clinical pipeline. A significant share repurchase of $2.0 billion was completed, further underscoring their long-term value outlook.

Pipeline Transformation

Incyte has strategically reviewed its pipeline and is now focusing on high-impact programs. Key areas include:

1. IAI/Dermatology: Emphasis on povorcitinib and MRGPRX2 and MRGPRX4 programs, recently acquired from Escient Pharmaceuticals.
2. MPNs/GVHD: Advancing mCALR, JAK2V617Fi, BETi, and ALK2i projects.
3. Oncology: Developing CDK2i, KRASG12Di, and TGFßR2×PD-1 programs.

Development of small molecule PD-L1 inhibitors, LAG-3 monoclonal antibodies, TIM-3 monoclonal antibodies, and LAG-3xPD-1 bispecific programs will be discontinued.

Recent Updates

Incyte announced positive topline results from two Phase 3 clinical studies evaluating retifanlimab (Zynyz®) in squamous cell anal carcinoma (SCAC) and non-small cell lung cancer (NSCLC). Both studies met primary endpoints, with retifanlimab showing good tolerance and no new safety signals. Detailed data will be presented in the second half of 2024.

In June 2024, Incyte repurchased 33,325,849 shares of its common stock for approximately $2.0 billion. This repurchase represented about 14.8% of the Company’s total outstanding shares as of June 7, 2024.

In May 2024, Incyte completed the acquisition of Escient Pharmaceuticals, gaining novel small molecule therapeutics for systemic immune and neuro-immune disorders, including EP262 and EP547.

In April 2024, Incyte entered a collaboration and license agreement with China Medical System Holdings Limited for the development and commercialization of povorcitinib in various regions.

Product Performance

- Jakafi: Net product revenues for the second quarter reached $706 million, a 3% year-over-year increase. Patient demand grew by 9%, though net product revenue growth was slightly lower due to higher channel inventory levels at the end of the second quarter of 2023.
- Opzelura: Showed significant growth with net product revenues of $122 million, marking a 52% increase year-over-year. This was driven by patient demand, refills, and expanded payer coverage in both atopic dermatitis and vitiligo. In Europe, net product revenues were $11 million, with full reimbursement achieved in Spain, Italy, and France by the end of the quarter.

Additional Pipeline Updates

For Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD), ongoing trials include:
- Ruxolitinib XR (QD) for myelofibrosis, polycythemia vera, and GVHD.
- Combination trials of ruxolitinib with zilurgisertib and ruxolitinib with BETi are progressing.
- Axatilimab (anti-CSF-1R) pivotal Phase 2 study for chronic GVHD is under review.

In hematology and oncology:
- Pemigatinib (Pemazyre®) is in Phase 3 for cholangiocarcinoma and approved in the U.S. and Japan for myeloid/lymphoid neoplasms.
- Tafasitamab (Monjuvi®/Minjuvi®) is in various Phase 3 trials for diffuse large B-cell lymphoma (DLBCL) and other conditions.
- Retifanlimab (Zynyz®) has ongoing Phase 3 trials for squamous cell anal cancer and non-small cell lung cancer.

In inflammation and autoimmunity, particularly dermatology:
- Ruxolitinib cream (Opzelura®) continues to show efficacy in treating conditions such as hidradenitis suppurativa and prurigo nodularis, with several Phase 3 trials planned or ongoing.
- Povorcitinib is in Phase 2 trials for asthma and chronic spontaneous urticaria, with a Phase 3 study in prurigo nodularis expected to start in 2024.

With these advancements and strategic shifts, Incyte is positioning itself for continued growth and innovation in the biopharmaceutical industry.

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