Kiniksa Pharmaceuticals International Plc Q1 FY2025 earnings call

• Kiniksa started 2025 strongly, with ARCALYST's net product revenue reaching $137.8 million in Q1 2025, a 75% year-over-year growth.
• ARCALYST has been on the market for 4 years, with expanding adoption by new and repeat prescribers, high payer approval rates, and a multiyear disease duration.
• Q1 2025 marks the fourth anniversary of ARCALYST's FDA approval in recurrent pericarditis.
• ARCALYST net sales guidance has been increased to between $590 million and $605 million for 2025, up from the prior range of $560 million to $580 million.
• KPL-387 is on track to initiate its Phase II/Phase III clinical trial in mid-2025, with Phase II data expected in the second half of 2026.
• Kiniksa remains cash flow positive, ending Q1 2025 with $268.3 million in cash.
• ARCALYST is currently manufactured by Regeneron in the US, and its transfer to Samsung Biologics in South Korea is underway, with tariffs expected to have an immaterial impact on cost of goods sold.

ARCALYST generated net product revenue of $137.8 million in the first quarter of 2025, representing a 75% year-over-year increase. ARCALYST contributed significantly to the overall revenue, with this $137.8 million being the net product revenue for Q1 2025.

• ARCALYST net sales guidance for 2025 is increased to between $590 million and $605 million, up from the previous range of $560 million to $580 million.
• KPL-387 is scheduled to initiate its Phase II/Phase III clinical trial in mid-2025, with Phase II data anticipated in H2 2026.
• Kiniksa expects to remain cash flow positive on an annual basis.

• Potential tariffs on pharmaceuticals could affect ARCALYST cost of goods sold if extended, but the transfer to Samsung Biologics in South Korea is expected to limit the impact to immaterial levels.
• Uncertainties exist regarding the future dynamics of Medicare Part D patients, including potential disenrollment and opt-outs.

Q: Could you comment on what could be driving the increased usage duration of ARCALYST and feedback from patient experience?

A: Drivers include healthcare professionals understanding it's a multiyear disease, patients tolerating therapy well, and patient services program supporting adherence.

Q: Regarding patient penetration, can you comment on scripts from first recurrence and R&D cost?

A: Around 15% of scripts are from first recurrence, R&D was flat on an adjusted basis, with KPL-387 in development.

Q: Initiatives to increase prescriber base and gross to net?

A: Focus on field execution and digital marketing, gross to net in Q1 2025 was 10.7%, lower than Q1 2024 due to Medicare Part D changes.

Q: New unique prescribers coming from community setting?

A: Focus on specialty cardiologists, not community setting, following patient journey for resource allocation.

Q: Development of KPL-387 trial design and switch component?

A: Phase II/III trial to start mid-2025, details to come, clinicaltrials.gov for updates.

Q: How many new physicians driven by Medicare Part D and continuation of benefit?

A: Vast majority of Medicare Part D patients were historic on PAP, a onetime bolus, with uncertainties on future dynamics.