Incyte (NASDAQ:INCY) Corporation reported double-digit revenue growth in Q3 2023, with product and royalty revenues reaching $914 million, driven by strong performances from Jakafi and Opzelura. The company also shared positive results from its clinical development efforts and provided updates on its pipeline of high potential programs.
Key takeaways from the call include:
- Jakafi's net sales were impacted by inventory variation, but Opzelura continued its growth trajectory, contributing $92 million in net product revenue.
- Incyte secured Small Biotech Exception status for ruxolitinib, exempting Jakafi from negotiation until 2029.
- Opzelura will be listed as a preferred brand on the CVS Caremark and Aetna formularies from 2024, improving access for patients.
- The company reported positive results for povorcitinib in prurigo nodularis and vitiligo.
- Incyte has initiated a Phase I study for its resident memory T cells treatment for vitiligo and dosed the first patient for a Phase I study of their anti-mutant CALR targeted monoclonal antibody.
- The company plans to file an IND for a program targeting the JAK2V617F mutation by the end of 2023.
- Incyte reported Q3 total product revenues of $783 million, a 10% YoY increase, and Jakafi net product revenues of $636 million for Q3.
- The company tightened its guidance range for Jakafi to $2.59 billion to $2.62 billion for 2023.
During the call, Incyte executives highlighted the potential of their pipeline programs, including a novel preclinical program targeting the JAK2V617F mutation. They also discussed their efforts to develop compounds that target new areas of biology and mentioned the possibility of combination therapies with Jakafi.
The company reported positive Phase III results for axatilimab in graft-versus-host disease and highlighted the potential of ALK2 in addressing hepcidin inhibition and improving hemoglobin levels. They also provided updates on their ruxolitinib cream program for atopic dermatitis and vitiligo, as well as their Opzelura program for other dermatologic conditions.
In terms of financials, Incyte reported a 10% year-over-year increase in Q3 total product revenues, reaching $783 million. Jakafi net product revenues amounted to $636 million for the quarter.
Incyte is also developing a drug targeting mutant CALR and JAK2V617F mutations, which could potentially eliminate the clone and modify the disease. They are excited about the potential of these new treatments but acknowledge that it is still early in the development process.
Finally, Steven Stein of Incyte Corporation discussed the progress of their XR program, which is currently under review by the FDA. The company aims to obtain XR approval before the loss of exclusivity (LOE) for their drug RUX. They also plan to start registration studies for their BET and ALK programs by the end of this year or early next year.
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