On February 28, 2024 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage 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 2023 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, FEB 28, 2024, View Source [SID1234640618]).

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"Kiniksa meaningfully advanced its business in 2023, primarily through robust ARCALYST net product revenue and collaboration profit growth. Significant growth remains with ARCALYST in recurrent pericarditis, and we expect to help an increasing number of patients in the years ahead. Importantly, we anticipate our robust commercial performance to contribute to our strong financial position and ability to drive growth across our business," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Additionally, abiprubart recently showed clinical effect in the first three cohorts of the Phase 2 trial in rheumatoid arthritis. We now expect to advance the asset into a Phase 2b trial in a new indication, funding for which is included in our current cash runway guidance. Data from the fourth cohort of the abiprubart Phase 2 trial are intended to inform trial design and are expected in April."

Portfolio and Collaboration Execution
ARCALYST (IL-1α and IL-1β cytokine trap)

ARCALYST net product revenue was $71.2 million and $233.2 million for the fourth quarter and full-year 2023, respectively.
Since launch in April 2021, more than 1,700 prescribers have written ARCALYST prescriptions for recurrent pericarditis.
As of the end of the fourth quarter of 2023, average total duration of ARCALYST therapy in recurrent pericarditis had increased to approximately 23 months.
As of the end of the fourth quarter of 2023, approximately 9% of the target 14,000 multiple-recurrence patients were actively on ARCALYST treatment.
A poster entitled Rilonacept Utilization in a Steroid-Sparing Paradigm for Recurrent Pericarditis: Real-World Evidence Demonstrating Increased Adoption is planned to be presented at the upcoming American College of Cardiology Scientific Session (ACC.24) in April 2024.
Abiprubart (anti-CD40 monoclonal antibody inhibitor of CD40-CD154 interaction)

Kiniksa previously announced topline data from the Phase 2 clinical trial of abiprubart in rheumatoid arthritis, showing that the trial met its primary efficacy endpoint: change from baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) versus placebo.
In Cohorts 1 and 2 (pharmacokinetic lead-in), multiple doses of abiprubart were well-tolerated.
In Cohort 3, the abiprubart 5 mg/kg subcutaneous (SC) weekly dose level achieved statistical significance. The 5 mg/kg SC biweekly dose level did not achieve statistical significance. Across both dose levels abiprubart reduced Rheumatoid Factor, a clinical marker of disease activity and an autoantibody pharmacodynamic marker of CD40 target engagement. Abiprubart was well-tolerated, with no dose-related adverse experiences observed.
Kiniksa expects data from the fourth cohort (Cohort 4) of the Phase 2 clinical trial in April 2024. Cohort 4 will evaluate a fixed dose level administered as a single subcutaneous injection once monthly.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

Kiniksa is evaluating potential partnership opportunities to advance development of mavrilimumab, which has generated positive data in mid-stage clinical trials across multiple indications.
Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

In the fourth quarter of 2023, Kiniksa recognized a $10.0 million development milestone related to a second new indication under its global license agreement with Genentech, a member of the Roche Group.
Financial Results

Total revenue for the fourth quarter of 2023 was $83.4 million, compared to $61.9 million for the fourth quarter of 2022. Total revenue for the full-year 2023 was $270.3 million, compared to $220.2 million for the full-year 2022.
Total revenue for the fourth quarter of 2023 included $12.2 million in license and collaboration revenue, compared to $21.9 million for the fourth quarter of 2022.
Total revenue for the full-year 2023 included $37.1 million in license and collaboration revenue, compared to $97.7 million for the full-year 2022.
Total operating expenses for the fourth quarter of 2023 were $83.3 million, compared to $55.8 million for the fourth quarter of 2022. Total operating expenses for the full-year 2023 were $295.5 million, compared to $210.4 million for the full-year 2022.
Total operating expenses for the fourth quarter of 2023 included $16.9 million in collaboration expenses, which are driven by ARCALYST collaboration profitability, compared to $7.5 million for the fourth quarter of 2022. Total operating expenses for the full-year 2023 included $56.5 million in collaboration expenses, compared to $24.1 million for the full-year 2022.
Total operating expenses for the fourth quarter of 2023 included $7.8 million in non-cash, share-based compensation expense, compared to $6.4 million for the fourth quarter of 2022. Total operating expense for the full-year 2023 included $27.1 million in non-cash, share-based compensation expense, compared to $25.1 million for the full-year 2022.
Net income for the fourth quarter of 2023 was $25.2 million, compared to net income of $4.5 million for the fourth quarter of 2022. Net income for the full-year 2023 was $14.1 million, compared to net income of $183.4 million for the full-year 2022.
Net income for the fourth quarter of 2023 included a tax benefit of $22.8 million, primarily due to the treatment of non-cash deferred tax assets, compared to a tax expense of $2.4 million for the fourth quarter of 2022.
Net income for the full-year 2023 included a tax benefit of $30.7 million, compared to a tax benefit of $172.3 million for the full-year 2022, both primarily due to the treatment of non-cash deferred tax assets.
As of December 31, 2023, Kiniksa had $206.4 million of cash, cash equivalents, and short-term investments and no debt.
Financial Guidance

Kiniksa expects 2024 ARCALYST net product revenue of between $360 million and $380 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 Wednesday, February 28, 2024, to discuss fourth quarter and full-year 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.