On July 25, 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 second quarter 2023 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, JUL 25, 2023, View Source [SID1234633413]).

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"Kiniksa continues to make significant progress in bringing ARCALYST, the first and only FDA-approved therapy for recurrent pericarditis, to patients in need. As a result of increased call frequency and expanded reach with target prescribers, we are seeing increased prescriber adoption and patient enrollments. We are still in the early stages of building the recurrent pericarditis market and remain encouraged by the high level of patient satisfaction, payer approval rates, and duration of therapy. These key metrics provide conviction in raising our 2023 ARCALYST sales guidance to between $220 million and $230 million," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Within our pipeline, we continue to enroll patients in the KPL-404 Phase 2 trial in rheumatoid arthritis and expect data in the first half of 2024. Additionally, we have a strong financial position and our cash reserves, combined with our continued ARCALYST commercial execution and financial discipline, now provide cash runway into at least 2027."

Portfolio and Collaboration Execution

ARCALYST (IL-1α and IL-1β cytokine trap)

• ARCALYST net product revenue was $54.5 million for the second quarter of 2023.

• Since launch, more than 1,250 prescribers have written ARCALYST prescriptions for recurrent pericarditis.

• As of the end of the second 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.

KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)

• Kiniksa is enrolling patients in 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.

Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

• In the second quarter of 2023, Kiniksa recognized a $15.0 million development milestone related to a new indication under its global license agreement with Genentech, a member of the Roche Group (Genentech).

Financial Results

• Total revenue for the second quarter of 2023 was $71.5 million, compared to $27.0 million for the second quarter of 2022.

- Total revenue for the second quarter of 2023 included $54.5 million in ARCALYST net product revenue and $17.0 million in license and collaboration revenue, compared to $27.0 million in ARCALYST net product revenue and $0.0 million in license and collaboration revenue for the second quarter of 2022.

• Total operating expenses for the second quarter of 2023 were $74.6 million, compared to $46.3 million for the second quarter of 2022.

- Total operating expenses for the second quarter of 2023 included $6.5 million in non-cash, share-based compensation expense, compared to $6.7 million for the second quarter of 2022.

• Net income for the second quarter of 2023 was $15.0 million, compared to a net loss of $20.0 million for the second quarter of 2022.

- Net income for the second quarter of 2023 included a $16.2 million tax benefit primarily due to the release of a valuation allowance on non-cash deferred tax assets.

• As of June 30, 2023, Kiniksa had $185.0 million of cash, cash equivalents, and short-term investments and no debt.

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Financial Guidance

• Kiniksa now expects 2023 ARCALYST net product revenue of between $220 million and $230 million compared to prior guidance 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 2027.

Conference Call Information

• Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, July 25, 2023, to discuss second 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.