Incyte (INCY) investor relations material

Strategic priorities and leadership vision

• Focus remains on oncology and immunology, particularly hematology and immune-mediated skin conditions, leveraging differentiated expertise and strong financials to drive growth into the next decade.

• Emphasis on converting scientific innovation into cash flow, with a team-oriented environment and robust internal R&D supported by a growing balance sheet.

• R&D resource allocation prioritizes hematology-oncology, followed by immunology, with all projects evaluated for return on investment and opportunity cost.

• Mission-critical MPN business and targeted oncology approach, with competitive positioning and early market entry as key strategies.

• AI is integrated across departments to enhance efficiency, particularly in regulatory processes, with over 20 AI agents in use.

Pipeline and product development updates

• Five targeted therapies in development for MF, PV, and ET, aiming to shift the market toward innovation-based, mutation-specific treatments.

• Monoclonal antibody 989 for mCALR mutations in MF and ET to present new data in December, with phase 3 trials for ET targeted to start by mid-2026.

• Jakafi XR, a once-daily formulation, expected to launch mid-2026, with exclusivity into the early 2030s and conversion rates projected between 10% and 30%.

• JAK2 V617F small molecule program is optimizing dosing for efficacy, with safety not currently a concern.

• Monjuvi is expanding beyond third-line use, with ongoing studies in sub-Q formulation and combinations, targeting results by 2026–2027.

Regulatory and clinical strategy

• Ongoing discussions with FDA for phase 3 trial design and endpoints, aiming to incorporate both traditional clinical and molecular endpoints for new therapies.

• Regulatory endpoints for ET and MF include hematologic response, symptom control, anemia benefit, and molecular response, with the goal of long-term disease modification.

• Combination and monotherapy strategies for 989 are being evaluated across multiple patient populations, including second-line and low-risk groups.

• Sub-Q dosing and patient-friendly schedules are under consideration to improve adherence and outcomes.