Kiniksa Pharmaceuticals reported strong commercial performance for its flagship product ARCALYST, with fourth quarter 2024 net product revenue reaching $122.5 million and full-year revenue of $417.0 million, marking a significant 79% growth from the previous year.
"Strong commercial execution in 2024 resulted in 79% year-over-year ARCALYST sales growth to $417.0 million. We believe substantial opportunity remains for ARCALYST, and expect 2025 sales of between $560 and $580 million," stated Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa.
ARCALYST Market Penetration and Patient Adoption
Since its launch, ARCALYST has demonstrated strong market acceptance, with more than 2,850 prescribers writing prescriptions for recurrent pericarditis. The average duration of therapy has reached approximately 27 months, indicating strong patient retention. Currently, about 13% of the target 14,000 multiple-recurrence patients are actively receiving ARCALYST treatment.
Strategic Pipeline Development
The company announced significant progress in its cardiovascular pipeline, particularly with KPL-387, a novel fully human immunoglobulin G2 monoclonal antibody. Following successful interactions with the FDA, Kiniksa plans to initiate a Phase 2/3 clinical trial for KPL-387 in recurrent pericarditis by mid-2025, with Phase 2 data expected in the second half of 2026.
KPL-387's development aims to provide patients with a more convenient monthly subcutaneous injection option in a liquid formulation. The drug works by binding to interleukin-1 receptor 1 (IL-1R1), effectively inhibiting IL-1α and IL-1β signaling.
Portfolio Optimization and Financial Position
In line with its strategic focus on cardiovascular indications, Kiniksa announced the discontinuation of abiprubart development in Sjögren's Disease. The company will explore strategic alternatives for this asset while maintaining its focus on core cardiovascular programs.
The company's financial position remains strong, with $243.6 million in cash, cash equivalents, and short-term investments as of December 31, 2024, compared to $206.4 million at the end of 2023. Notably, Kiniksa carries no debt and expects to maintain positive cash flow on an annual basis under its current operating plan.
Future Outlook
Looking ahead to 2025, Kiniksa has provided guidance for ARCALYST net product revenue between $560 million and $580 million, reflecting continued confidence in the product's growth trajectory. The company's strategic focus on cardiovascular indications, coupled with its strong commercial execution and pipeline advancement, positions it well for sustained growth in the coming years.
