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Kiniksa Pharmaceuticals International (KNSA) investor relations material
Kiniksa Pharmaceuticals International Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Commercial performance and market opportunity
ARCALYST has generated over $1 billion in net product revenue since FDA approval for recurrent pericarditis, with only 15% market penetration in the multiple recurrence population and further upside in first recurrence patients.
Net revenue guidance for 2025 was raised to $670–$675 million, reflecting strong sales momentum and a 61% year-over-year increase in Q3 2025 net product revenue to $180.9 million.
About 80% of ARCALYST prescriptions are for patients with two or more recurrences, while 20% are now for first recurrence, up from 15% last year, indicating earlier adoption in the disease course.
Physician education, streamlined prescribing, and network expansion from 2 to 18 specialized pericardial disease centers support growth.
The company maintains a strong financial position with over $350 million in cash reserves and ongoing annual cash flow positivity, enabling continued investment in growth and pipeline development.
Commercial strategy and market expansion
Commercial strategy includes broad label promotion, prescriber support, and network development.
Recognition of recurrent pericarditis as a chronic disease is driving demand for effective, well-tolerated treatments.
ARCALYST net revenue has grown substantially year-over-year, driven by earlier adoption and broader use.
Pipeline development and clinical strategy
KPL-387, a fully human monoclonal antibody targeting IL-1R1, is in phase 2/3 development for recurrent pericarditis, with orphan drug designation granted by the FDA in October and phase II data expected in the second half of 2026.
KPL-387 is designed for once-monthly subcutaneous dosing via autoinjector, with market research showing over 75% of patients and 90% of physicians would prefer or prescribe it over current options.
The phase 2/3 program includes a dose-focusing phase, pivotal phase III, and long-term extension, leveraging experience from the successful RHAPSODY trial.
A supplemental study will assess transitioning patients from other therapies to KPL-387, aiming for a comprehensive data package at launch.
IND-enabling activities are ongoing for KPL-1161, a quarterly IL-1 inhibitor, expanding the clinical pipeline.
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