On October 31, 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 third quarter 2023 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, OCT 31, 2023, View Source [SID1234636532]).
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"We continue to advance all aspects of our business, including strong revenue growth with ARCALYST and clinical trial execution with KPL-404, and we have cash runway into at least 2027," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "On the commercial side, we are building the recurrent pericarditis market and are focused on helping as many patients as possible. We are currently tracking to the high end of our previously issued guidance of $220 million to $230 million in product revenue. Within our clinical development portfolio, we have completed enrollment in the third cohort of the Phase 2 trial of KPL-404 in rheumatoid arthritis. We now expect data from Cohorts 1-3 in the first quarter of 2024."
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)
· ARCALYST net product revenue was $64.8 million for the third quarter of 2023.
· Since launch, more than 1,450 prescribers have written ARCALYST prescriptions for recurrent pericarditis.
· As of the end of the third quarter of 2023, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 20 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.
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KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)
· Kiniksa completed enrollment of the third cohort of the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. The company now expects data from Cohorts 1-3 in the first quarter of 2024.
· Kiniksa is currently enrolling a fourth cohort (Cohort 4) of the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. The additional cohort will evaluate a fixed dose level administered as a single subcutaneous injection once monthly. The company expects data from Cohort 4 in the second quarter 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
· ARCALYST net product revenue for the third quarter of 2023 was $64.8 million, compared to $33.4 million for the third quarter of 2022.
- Total revenue for the third quarter of 2023 was $67.0 million, including $2.2 million in license and collaboration revenue, compared to total revenue for the third quarter of 2022 of $99.1 million, including $65.7 million in license and collaboration revenue.
· Total operating expenses for the third quarter of 2023 were $78.0 million, compared to $52.7 million for the third quarter of 2022.
- Total operating expenses for the third quarter of 2023 included $17.3 million in collaboration expenses, due to increasing ARCALYST profitability, compared to $4.6 million for the third quarter of 2022.
- Total operating expenses for the third quarter of 2023 included $6.8 million in non-cash, share-based compensation expense, compared to $6.0 million for the third quarter of 2022.
· Net loss for the third quarter of 2023 was $13.9 million, compared to net income of $224.1 million for the third quarter of 2022.
· As of September 30, 2023, Kiniksa had $201.1 million of cash, cash equivalents, and short-term investments and no debt.
Financial Guidance
· Kiniksa expects 2023 ARCALYST net product revenue of between $220 million and $230 million.
· Kiniksa expects that its cash, cash equivalents, and short-term investments will fund its current operating plan into at least 2027.
Conference Call Information
· Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, October 31, 2023, to discuss third 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.