Portfolio Execution ARCALYST (IL-1α and IL-1β cytokine trap) LONDON, July 23, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (NASDAQ:KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immunemodulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported second quarter 2024 financial results and recent portfolio execution. ARCALYST net product revenue was $103.4 million for the second quarter of 2024. Since launch in ...

Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa's immune-modulating assets, ARCALYST®, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more informatio ...

LONDON, July 16, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Tuesday, July 23, 2024 at 8:30 a.m. Eastern Time to report its second quarter 2024 financial results and recent portfolio execution. A live webcast will be accessible through the Investors & Media section of the company's website at www.kiniksa.com. Individuals interested in participating in the call via telephone may register here. Upon ...

Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa's immune-modulating assets, ARCALYST®, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more informatio ...

– Abiprubart Phase 2b clinical trial in Sjögren's Disease to evaluate treatment response across biweekly and monthly subcutaneous administrations – LONDON, July 09, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (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, today announced that it has commenced enrollment of the Phase 2b clinical trial of abipruba ...

– American Heart Association to work with champions at 15 healthcare sites to implement initiative activities and improve care quality – "We are proud to sponsor the American Heart Association's Addressing Recurrent Pericarditis initiative. Recurrent pericarditis is a rare, chronic, flaring disease, in which patients are frequently misdiagnosed or undertreated due to a lack of access to expert care. In addition to elevating awareness and knowledge around recurrent pericarditis, this initiative will also hel ...

Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa's immune-modulating assets, ARCALYST, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more information ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38492 Kiniksa Pharmaceuticals, Ltd. (Exact Name of Registrant as Specified in Its Charter) (State or Other Ju ...

Financial Data and Key Metrics - Q1 2024 net revenue for ARCALYST was $78.9 million, representing 85% YoY growth [20] - Total revenue for Q1 2024 was $79.9 million, driven by ARCALYST net product revenue [38] - ARCALYST collaboration operating profit grew 142% YoY to $40.2 million in Q1 2024 [39] - Net loss in Q1 2024 was $17.7 million, compared to $12.3 million in Q1 2023 [28] - Cash balance at the end of Q1 2024 was $213.6 million, reflecting net cash flow of $7.2 million [28] Business Line Data and Key Metrics - ARCALYST full-year sales guidance for 2024 increased to $370 million - $390 million, representing 63% YoY growth at the midpoint [5] - Total prescribers of ARCALYST grew to approximately 2,000 at the end of Q1 2024, marking the largest quarter-on-quarter growth since launch [8] - Greater than 90% payer approval rate for completed cases and an average duration of therapy of 23 months for ARCALYST [8] - 40% of new prescriptions in Q1 were written by repeat prescribers [22] Market Data and Key Metrics - Only 9% of the target population for ARCALYST has been addressed as of the end of 2023, indicating significant growth potential [25] - The RESONANCE Registry shows a paradigm shift in recurrent pericarditis management, with 65% of transitions in 2023 made to ARCALYST, a 2:1 preference over corticosteroids [11] Company Strategy and Industry Competition - The company plans to initiate a Phase 2b trial for Abiprubart in Sjögren's Disease in the second half of 2024, targeting a debilitating disease with no FDA-approved therapies [19][27] - ARCALYST is positioned as a steroid-sparing therapy, addressing the root cause of recurrent pericarditis through IL-1 pathway inhibition [33] - The company expects to remain cash flow positive on an annual basis, supported by strong commercial execution and financial discipline [29][31] Management Commentary on Operating Environment and Future Outlook - Management highlighted robust growth in ARCALYST, driven by increasing prescriber adoption and high physician and patient satisfaction [4][17] - The company is optimistic about the future of ARCALYST, with strong underlying business fundamentals and significant market opportunity [25][31] - Management emphasized the importance of the RESONANCE Registry in understanding disease management and driving evidence-based adoption of ARCALYST [71][92] Other Important Information - The company received a $10 million development milestone from Genentech in Q1 2024, previously recognized as revenue in Q4 2023 [28] - The Phase 2b trial for Abiprubart will evaluate subcutaneous administration with biweekly and monthly dosing regimens, aiming for differentiation in the Sjögren's Disease market [27][66] Q&A Session Summary Question: Growth in ARCALYST prescribers and sales force impact [46] - The growth in prescribers is attributed to both the expanded sales force, which now covers 11,000 physicians, and deeper penetration into top-tier academic centers [57][59] Question: Patient behavior trends and therapy restart rates [80] - Restart rates for ARCALYST therapy remain consistent at 45%, with no significant changes in patient behavior observed [80][81] Question: Competitive landscape for Abiprubart in Sjögren's Disease [53] - Abiprubart's differentiation lies in its subcutaneous dosing and strong biological activity, with a 40% reduction in rheumatoid factor across all dosing regimens [65][66] Question: ARCALYST market shift and physician paradigm [85] - The market is shifting towards using ARCALYST after initial treatments like Aspirin and Colchicine fail, particularly for patients with multiple recurrences [85][86] Question: Strategic importance of profitability vs pipeline expansion [70] - The company remains committed to both profitability and pipeline expansion, with a focus on creating value while maintaining cash flow positivity [74][75] Question: Plans for publishing RESONANCE Registry data [90] - The RESONANCE Registry is a key tool for understanding disease management, and the company plans to continue sharing insights from the registry [71][92]

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|--------------------------|------------------------------------|----------------------|-------|--------------------------|-------|----------------------------------------------------------------------------------------------------------|-------|-----------------------|-----------------|--------------|---------------------------------------------| | | 15% | 12% 00/ | 2% \n740 | | 4% \n29/0 | | | 100% | Rilonacept in RP \ ...