Kiniksa Pharmaceuticals International (KNSA) investor relations material

Strategic priorities and financial outlook

• Focused on expanding commercial success of ARCALYST in recurrent pericarditis, with revenue guidance for 2026 raised to $930–$945 million and strong Q1 growth reported.

• Advancing pipeline assets, notably KPL-387 (phase II/III) with phase II results expected in H2 2024 and phase III initiation by year-end.

• Preparing KPL-1161, a long-acting IL-1 receptor antagonist, for phase I trials by end of 2024, targeting quarterly dosing and broader autoinflammatory indications.

• Maintains robust financials with profitability and $468 million in cash reserves as of Q1.

• Committed to value creation and maintaining strategic flexibility for future growth.

Commercial performance and market evolution

• ARCALYST has achieved significant market penetration, reaching 18% of high-burden patients (two or more recurrences) and expanding into first recurrence patients.

• Q1 2024 saw the highest number of new prescribers and patient enrollments since launch, with over 4,550 total prescribers out of a 25,000-physician base.

• Shift in prescriber mix toward cardiologists, with rheumatologists still contributing but to a lesser extent; minimal primary care involvement.

• Both breadth (new prescribers) and depth (repeat prescribers, now 29% of total) are driving growth.

• Treatment paradigm has shifted from episodic to chronic management, with ARCALYST now used for long-term prevention.

Pipeline development and clinical innovation

• KPL-387 phase II/III trial uses a four-arm dose-finding design, focusing on monthly and biweekly dosing intervals, with phase II data expected H2 2024.

• KPL-387 targets IL-1R1 via monoclonal antibody, aiming for once-monthly dosing and self-administration, differentiating from ARCALYST’s cytokine trap approach.

• Phase III trial for KPL-387 will be global, double-blind, and event-driven, leveraging learnings from RHAPSODY and adapting to evolving clinical guidelines.

• KPL-1161, with Fc modifications for quarterly dosing, is positioned for broader autoinflammatory diseases, with phase I start planned for late 2024.

• Regulatory strategy for KPL-387 integrates phase II/III in a seamless protocol, aiming for pivotal registration with a single trial.