On May 2, 2023 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, reported first quarter 2023 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, MAY 2, 2023, View Source [SID1234630845]).
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"Kiniksa continues to make great progress in developing the recurrent pericarditis market. ARCALYST, the first and only FDA-approved therapy for this disease, is reshaping the treatment paradigm. We are seeing signs of success from our field team expansion, with recent increases in prescriber adoption and patient enrollments. In addition to these metrics, given the high patient satisfaction, strong payer approval rates, and longer duration of therapy, we’ve raised our 2023 ARCALYST sales guidance to between $200 and $215 million," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "We are also now enrolling the final cohort of the KPL-404 Phase 2 trial in rheumatoid arthritis and expect data in the first half of 2024. Our cash reserves, combined with our continued ARCALYST commercial execution and financial discipline, provide cash runway into at least 2026."
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)
· ARCALYST net product revenue was $42.7 million for the first quarter of 2023.
· Since launch, more than 1,000 prescribers have written ARCALYST prescriptions for recurrent pericarditis.
· As of the end of the first quarter of 2023, there was a greater than 90% payer approval rate of completed patient cases for recurrent pericarditis.
· As of the end of the first quarter of 2023, average total duration of ARCALYST therapy in recurrent pericarditis increased to approximately 20 months.
- Average initial duration of therapy increased to approximately 14 months.
- Average total duration of therapy includes the approximately 45% of patients who restarted ARCALYST, within an average of 8 weeks, after having discontinued therapy.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)
· Kiniksa is enrolling the final cohort of the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. The company expects data from the trial in the first half of 2024.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)
· Kiniksa is pursuing collaborative study agreements to evaluate the potential of mavrilimumab in rare cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated.
Financial Results
· Total revenue for the first quarter of 2023 was $48.3 million, compared to $32.2 million for the first quarter of 2022.
- Total revenue for the first quarter of 2023 included $42.7 million in ARCALYST net product revenue and $5.7 million in license and collaboration revenue, compared to $22.2 million in ARCALYST net product revenue and $10.0 million in license and collaboration revenue for the first quarter of 2022.
· Total operating expenses for the first quarter of 2023 were $59.5 million, compared to $55.5 million for the first quarter of 2022.
- Total operating expenses for the first quarter of 2023 included $6.1 million in non-cash, share-based compensation expense, compared to $6.0 million for the first quarter of 2022.
· Net loss for the first quarter of 2023 was $12.3 million, compared to a net loss of $25.2 million for the first quarter of 2022.
· As of March 31, 2023, Kiniksa had $187.5 million of cash, cash equivalents, and short-term investments and no debt.
Financial Guidance
· Kiniksa now expects ARCALYST net product revenue for the full-year 2023 of between $200 million and $215 million.
· Kiniksa now expects that its cash and cash equivalents will fund its current operating plan into at least 2026.
Conference Call Information
· Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, May 2, 2023 to discuss first quarter 2023 financial results and recent portfolio execution.
· Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.