On February 28, 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 fourth quarter and full-year 2022 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, FEB 28, 2023, View Source [SID1234627850]).
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"Kiniksa executed across its cardiovascular and emerging autoimmune franchises in 2022," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Within the cardiovascular franchise, we are focused on increasing brand awareness of ARCALYST, the only FDA-approved treatment for recurrent pericarditis, and pursuing collaborative study agreements for mavrilimumab in rare cardiovascular diseases. In our emerging autoimmune franchise, we believe KPL-404, our CD40 antagonist, has significant potential for differentiation in targeting chronic autoimmune diseases. We are advancing the Phase 2 trial of KPL-404 in rheumatoid arthritis into the efficacy portion and expect data in the first half of 2024. Additionally, our profitable ARCALYST collaboration, non-dilutive capital from strategic out-licensing transactions, and continued financial discipline support these efforts while providing cash runway into at least 2025."
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)
· ARCALYST net product revenue was $39.9 million and $122.5 million for the fourth quarter and full-year 2022, respectively.
· Since launch, greater than 800 prescribers have written ARCALYST prescriptions for recurrent pericarditis, with 22% having written prescriptions for 2 or more patients.
· As of the end of the fourth quarter of 2022, there was a greater than 90% payer approval rate of completed patient cases for recurrent pericarditis.
· As of the end of the fourth quarter of 2022, ARCALYST average total duration of therapy was approximately 18 months after accounting for the approximately 45% of recurrent pericarditis patients who had discontinued therapy and restarted treatment.
- ARCALYST average initial duration of therapy remained approximately 12 months as of the end of the fourth quarter of 2022.
· As of the end of the fourth quarter of 2022, approximately 5% of the target 14,000 multiple-recurrence pericarditis patients were actively on ARCALYST treatment.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)
· Kiniksa has completed enrollment of the second and final cohort of the multiple ascending dose portion of the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. Following completion of this portion of the trial, the proof-of-concept portion will begin. 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 fourth quarter of 2022 was $61.9 million, compared to $18.7 million for the fourth quarter of 2021. Total revenue for the full-year 2022 was $220.2 million, compared to $38.5 million for the full-year 2021.
- Total revenue for the fourth quarter of 2022 included $39.9 million in ARCALYST net product revenue and $21.9 million in license and collaboration revenue from Roche and Genentech, a member of the Roche Group (Genentech). Kiniksa did not report license and collaboration revenue in the fourth quarter of 2021.
- Total revenue for the full-year 2022 included $122.5 million in ARCALYST net product revenue and $97.7 million in license and collaboration revenue from Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd and Genentech. Kiniksa did not report license and collaboration revenue in 2021.
· Total operating expenses for the fourth quarter of 2022 were $55.8 million, compared to $54.9 million for the fourth quarter of 2021. Total operating expenses for the full-year 2022 were $210.4 million, compared to $195.2 million for the full-year 2021.
- Total operating expenses for the fourth quarter of 2022 included $6.4 million in non-cash, share-based compensation expense, compared to $6.1 million for the fourth quarter of 2021.
- Total operating expenses for the full-year 2022 included $25.1 million in non-cash, share-based compensation expense, compared to $25.2 million for the full-year 2021.
· Net income for the fourth quarter of 2022 was $4.5 million, compared to a net loss of $36.3 million for the fourth quarter of 2021. Net income for the full-year 2022 was $183.4 million, compared to a net loss of $157.9 million for the full-year 2021.
- Net income for the full-year 2022 included a $172.3 million tax benefit primarily due to the release of a valuation allowance on non-cash deferred tax assets.
· As of December 31, 2022, Kiniksa had $190.6 million of cash, cash equivalents, and short-term investments and no debt.
Financial Guidance
· Kiniksa expects ARCALYST net product revenue for the full-year 2023 of between $190 million and $205 million.
· Kiniksa expects that its cash and cash equivalents will fund its current operating plan into at least 2025.
Conference Call Information
· Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, February 28, 2023, to discuss fourth quarter and full-year 2022 financial results and to provide a corporate update.
· 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.