Revenue Performance - ARCALYST net product revenue for 2024 reached $416.4 million, reflecting a 79% year-over-year growth[1] - Kiniksa expects 2025 ARCALYST net product revenue to be between $560 million and $580 million[6] - There is substantial opportunity for Kiniksa to drive further ARCALYST revenue through its commercial strategy[2] Patient Engagement - Approximately 13% of the target population of 14,000 multiple-recurrence patients were actively on ARCALYST therapy by the end of 2024[5] - More than 2,850 prescribers have written ARCALYST prescriptions since its launch[5] - The average total duration of ARCALYST therapy in recurrent pericarditis was approximately 27 months as of the end of Q4 2024[5] Financial Position - Kiniksa had $243.6 million in cash, cash equivalents, and short-term investments as of December 31, 2024[11] - Kiniksa anticipates remaining cash flow positive on an annual basis[11] - Kiniksa's financial profile supports the pursuit of additional value-creating opportunities[2] Clinical Development - The company is advancing its clinical portfolio to bring new therapies to patients with unmet medical needs[2]

Core Insights - Kiniksa Pharmaceuticals reported strong sales growth for ARCALYST, achieving $417.0 million in net product revenue for the full year 2024, a 79% increase year-over-year [2][10] - The company expects ARCALYST net product revenue to reach between $560 million and $580 million in 2025 [2][10] - Kiniksa plans to discontinue the development of abiprubart in Sjögren's Disease and focus on cardiovascular indications [2][7] Financial Performance - Total revenue for Q4 2024 was $122.5 million, compared to $83.4 million in Q4 2023 [10][25] - Full year 2024 total revenue was $423.2 million, up from $270.3 million in 2023 [10][25] - The net loss for Q4 2024 was $8.9 million, compared to a net income of $25.2 million in Q4 2023 [10][25] - For the full year 2024, the net loss was $43.2 million, compared to a net income of $14.1 million in 2023 [10][25] Product Development - Kiniksa is advancing KPL-387 for recurrent pericarditis, with a Phase 2/3 clinical trial expected to start in mid-2025 [2][8][10] - KPL-387 aims to provide a single monthly subcutaneous injection option for patients [2][7] - KPL-1161 is also being developed with a target profile of quarterly subcutaneous dosing [7][9] Market Position - Since the launch of ARCALYST, over 2,850 prescribers have written prescriptions for recurrent pericarditis [7] - As of Q4 2024, approximately 13% of the target 14,000 multiple-recurrence patients were actively on ARCALYST treatment [7]

Core Insights - Kiniksa Pharmaceuticals plans to initiate a Phase 2/3 clinical trial of KPL-387 for recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026 [1][2][4] - KPL-387 is a monoclonal antibody targeting IL-1R1, which may allow for monthly subcutaneous dosing, enhancing treatment options for patients [2][4][8] - The company will discontinue the development of abiprubart for Sjögren's Disease and is exploring strategic alternatives for this asset [1][4][13] Company Strategy - Kiniksa focuses on developing therapies for diseases with unmet needs, particularly in cardiovascular indications [1][4] - The company has successfully commercialized ARCALYST, generating over $800 million in product revenue since its launch in 2021, and has become cash flow positive annually [2][4] - Kiniksa aims to increase its market penetration in recurrent pericarditis with ARCALYST while advancing KPL-387 [2][4] Product Development - KPL-387 is currently undergoing a Phase 1 clinical trial, with topline data supporting the potential for monthly subcutaneous dosing [4][8] - Kiniksa is also advancing KPL-1161, another monoclonal antibody with a target profile of quarterly subcutaneous dosing [4][9] - The company has engaged with the FDA regarding the development of KPL-387 and plans to initiate further clinical trials [2][4][13]

Core Viewpoint - Kiniksa Pharmaceuticals International, plc will host a conference call on February 25, 2025, to discuss its fourth quarter and full year 2024 financial results and recent portfolio execution [1]. Group 1: Conference Call Details - The conference call is scheduled for 8:30 a.m. Eastern Time on February 25, 2025 [1]. - A live webcast will be available on the company's website, and participants can register for telephone access [2]. - A replay of the event will be accessible on Kiniksa's website approximately 48 hours after the event [2]. Group 2: Company Overview - Kiniksa is a biopharmaceutical company focused on developing novel therapies for debilitating diseases, particularly in cardiovascular indications [3]. - The company's portfolio is based on strong biologic rationale or validated mechanisms, offering potential for differentiation in the market [3].

Core Viewpoint - Kiniksa Pharmaceuticals International, plc will host a conference call on February 25, 2025, to discuss its fourth quarter and full year 2024 financial results and recent portfolio execution [1]. Group 1: Conference Call Details - The conference call is scheduled for 8:30 a.m. Eastern Time on February 25, 2025 [1]. - A live webcast will be available on the company's website, and participants can register for telephone access [2]. - A replay of the event will be accessible on Kiniksa's website within approximately 48 hours after the event [2]. Group 2: Company Overview - Kiniksa is a biopharmaceutical company focused on developing novel therapies for debilitating diseases, particularly in cardiovascular indications [3]. - The company's portfolio is based on strong biologic rationale or validated mechanisms, offering potential for differentiation in the market [3].

Core Insights - Kiniksa Pharmaceuticals reported a net product revenue of $416.4 million for ARCALYST in 2024, reflecting approximately 79% year-over-year growth [1][2] - The company anticipates ARCALYST net product revenue for 2025 to be between $560 million and $580 million [1][6] - Kiniksa expects to maintain a positive cash flow on an annual basis [1][6] Commercial Performance - As of the end of 2024, around 13% of the target population for recurrent pericarditis was on ARCALYST therapy, contributing to the revenue growth [2][6] - The average duration of ARCALYST therapy for recurrent pericarditis patients was approximately 27 months [6] Corporate Update - Kiniksa's leadership will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025 [4] - A live webcast of the presentation will be available on Kiniksa's website, with a replay accessible within 48 hours post-event [4] Company Overview - Kiniksa is focused on developing and commercializing therapeutic medicines for patients with significant unmet medical needs, particularly in cardiovascular and autoimmune diseases [5] - The company’s immune-modulating assets are based on validated mechanisms and aim to address underserved conditions [5]

Core Insights - Kiniksa Pharmaceuticals reported a preliminary unaudited net product revenue of $416.4 million for ARCALYST in 2024, reflecting approximately 79% year-over-year growth [1][2][6] - The company anticipates ARCALYST net product revenue for 2025 to be between $560 million and $580 million [1][6] - Kiniksa expects to maintain a cash flow positive status on an annual basis [1][6] Commercial Performance - As of the end of 2024, around 13% of the target population for recurrent pericarditis was on ARCALYST therapy, contributing to the revenue growth [2][6] - Since the launch of ARCALYST, over 2,850 prescribers have written prescriptions for the drug [6] - The average duration of ARCALYST therapy in recurrent pericarditis patients was approximately 27 months by the end of Q4 2024 [6] Corporate Update - Kiniksa's leadership, including Chairman and CEO Sanj K. Patel, presented at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025 [4] - The company is focused on advancing its clinical portfolio to address unmet medical needs [2][5] Product Information - ARCALYST is a recombinant dimeric fusion protein that inhibits interleukin-1 alpha and beta signaling, approved for treating recurrent pericarditis and other conditions [6][7] - The drug received Orphan Drug Exclusivity from the FDA for recurrent pericarditis in 2021 and Orphan Drug Designation from the European Commission for idiopathic pericarditis [7]

Core Viewpoint - Kiniksa Pharmaceuticals International will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, highlighting its focus on therapeutic medicines for unmet medical needs [1]. Company Overview - Kiniksa is a commercial-stage biopharmaceutical company dedicated to discovering, acquiring, developing, and commercializing therapeutic medicines for patients with debilitating diseases [3]. - The company specializes in immune-modulating assets that target underserved cardiovascular and autoimmune conditions, aiming for differentiation based on strong biological rationale or validated mechanisms [3]. Event Details - The presentation will take place at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) [1]. - A live webcast of the presentation will be available on Kiniksa's website, with a replay accessible approximately 48 hours after the event [2].

Group 1 - Kiniksa Pharmaceuticals will participate in a fireside chat at the 2024 Jefferies London Healthcare Conference on November 19, 2024, at 12:00 p.m. GMT [1] - A live webcast of the presentation will be available on Kiniksa's website, with a replay accessible within approximately 48 hours after the event [2] - Kiniksa is a commercial-stage biopharmaceutical company focused on developing therapeutic medicines for patients with significant unmet medical needs, particularly in cardiovascular and autoimmune conditions [3]

Financial Performance - Product revenue for the three months ended September 30, 2024, was $112.2 million, a 65% increase from $64.8 million in the same period of 2023[18]. - Total revenue for the nine months ended September 30, 2024, reached $300.7 million, compared to $186.9 million for the same period in 2023, reflecting a 60% increase[18]. - The net loss for the three months ended September 30, 2024, was $12.7 million, compared to a net loss of $13.9 million for the same period in 2023[18]. - Net loss for the nine months ended September 30, 2024, was $34,305,000, compared to a net loss of $11,153,000 for the same period in 2023[22]. - Basic and diluted net loss attributable to ordinary shareholders for the three months ended September 30, 2024, was $(12,693) million, compared to $(13,855) million for the same period in 2023[115]. - The company reported a net loss of $34.3 million for the nine months ended September 30, 2024, compared to a net loss of $11.2 million in the same period of 2023[192]. Revenue Sources - Product revenue from ARCALYST for the three months ended September 30, 2024, was $112,214, representing a 73% increase from $64,802 in the same period of 2023[55]. - For the nine months ended September 30, 2024, product revenue was $294,493, up 82% from $161,956 in the prior year[55]. - Net revenue from the sale of ARCALYST reached $294.5 million for the nine months ended September 30, 2024, compared to $162.0 million for the same period in 2023, an increase of 81.6%[178]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $26.1 million, up from $17.1 million in the same period of 2023, indicating a 52% increase[18]. - Selling, general, and administrative expenses for the three months ended September 30, 2024, were $46.4 million, compared to $34.5 million in the same period of 2023, representing a 34% increase[18]. - Total operating expenses for the nine months ended September 30, 2024, were $327.0 million, up from $212.1 million in 2023, reflecting a 54.1% increase[179]. - Research and development expenses rose to $76.4 million for the nine months ended September 30, 2024, compared to $56.0 million in 2023, marking a 36.4% increase[183]. - Collaboration expenses increased to $80.1 million for the nine months ended September 30, 2024, compared to $39.6 million in 2023, a rise of 102.5%[183]. Cash and Investments - Cash and cash equivalents at the end of the period were $97,376,000, down from $117,828,000 at the end of September 2023[22]. - The company had cash, cash equivalents, and short-term investments totaling $223,780 as of September 30, 2024, which is expected to fund operations for at least twelve months[33]. - As of September 30, 2024, total unrecognized compensation expense related to unvested share option awards was $42,841, expected to be recognized over a weighted average remaining period of 2.58 years[67]. - The company’s total cash equivalents and short-term investments as of September 30, 2024, included $48,429 in money market funds and $126,404 in U.S. Treasury notes[49]. Financing and Capital Requirements - The company may require substantial additional financing to further its operational plans, which may not be obtainable on acceptable terms[11]. - The company expects to incur significant expenses related to the commercialization of ARCALYST and the development of product candidates, including ongoing clinical trials[200]. - The company anticipates requiring additional capital for collaboration, licensing, or strategic transactions, as well as for product manufacturing and marketing[202]. - Existing cash, cash equivalents, and short-term investments are expected to fund operating expenses for at least the next 12 months[202]. Collaboration Agreements - The Company entered into a license agreement with Genentech, receiving an upfront payment of $80,000 and additional cash payments totaling $55,000 for development milestones in 2023 and early 2024[75]. - The Company is eligible for approximately $600,000 in contingent payments under the Genentech License Agreement, with about $570,000 remaining as of September 30, 2024[75]. - The Company recognized $5,261 in collaboration revenue under the Genentech License Agreement during the nine months ended September 30, 2024, with $4,989 related to prior performance obligations[81]. - The Company received a total upfront cash payment of $22,000 under the Huadong Collaboration Agreements, with potential payments of up to $70,000 for rilonacept and $576,000 for mavrilimumab[83]. Research and Development Focus - The company is focused on developing therapeutic medicines for underserved cardiovascular and autoimmune conditions, indicating a strategic emphasis on unmet medical needs[24]. - The company is currently enrolling and dosing a Phase 2b clinical trial of abiprubart in Sjögren's Disease, following positive results from earlier cohorts in rheumatoid arthritis trials[141]. - The company has exclusive worldwide rights to develop and commercialize mavrilimumab, with ongoing evaluations for potential partnership opportunities[141]. Risks and Uncertainties - The company faces numerous risks and uncertainties in the research and commercialization of biologic products, impacting future funding requirements[203]. - The company has made significant estimates regarding revenue recognition, research and development expenses, and deferred tax assets, which may differ from actual results[31]. - Critical accounting policies involve significant judgment, particularly in accrued research and development expenses, revenue recognition, and realizability of deferred tax assets[205].