Kiniksa(US:KNSA)2025-10-28 20:15Financial Performance - Total revenue for Q3 2025 reached $180.9 million, a 61% increase compared to $112.2 million in Q3 2024[23] - Product revenue for the nine months ended September 30, 2025, was $475.4 million, up 61% from $294.5 million in the same period of 2024[23] - Net income for Q3 2025 was $18.4 million, compared to a net loss of $12.7 million in Q3 2024, marking a significant turnaround[23] - The company reported a comprehensive income of $18.3 million for Q3 2025, compared to a comprehensive loss of $12.6 million in Q3 2024[23] - For the nine months ended September 30, 2025, Kiniksa Pharmaceuticals reported a net income of $44,806, compared to a net loss of $34,305 for the same period in 2024[27] - For the three months ended September 30, 2025, total revenue was $180,855, an increase of 61% compared to $112,214 for the same period in 2024[131] - Product revenue for the nine months ended September 30, 2025, reached $475,437, up 61% from $294,493 in the prior year[131] - Net income for the three months ended September 30, 2025, was $18,435, compared to a net loss of $12,693 for the same period in 2024[103] - For the nine months ended September 30, 2025, the company reported a net income of $44.8 million, while the accumulated deficit stood at $476.3 million[143] Assets and Liabilities - Total assets increased to $712.3 million as of September 30, 2025, up from $580.6 million at the end of 2024, reflecting a growth of 22.7%[21] - Total current assets rose to $475.5 million, a 43% increase from $331.8 million at the end of 2024[21] - Shareholders' equity increased to $535.4 million as of September 30, 2025, compared to $438.4 million at the end of 2024, representing a growth of 22%[21] - The company’s total liabilities increased to $177.0 million as of September 30, 2025, compared to $142.1 million at the end of 2024, an increase of 24.6%[21] - Cash and cash equivalents were $174.9 million as of September 30, 2025, down from $183.6 million at the end of 2024[21] - Cash and cash equivalents at the end of the period were $174,858, up from $97,376 at the end of September 2024[27] - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $352,102[36] - As of September 30, 2025, the company had committed to minimum purchase commitments totaling $204,982 under various agreements, with $86,572 due within one year[124] Research and Development - Research and development expenses for Q3 2025 were $24.2 million, slightly down from $26.1 million in Q3 2024[23] - The company expects substantial research and development expenses in the coming years due to ongoing and planned clinical trials for its product candidates[161] - Research and development expenses decreased to $62.2 million for the nine months ended September 30, 2025, down from $76.4 million in 2024, a reduction of 18.6%[191] - Direct costs for the KPL-387 program were $11.4 million for the three months ended September 30, 2025, compared to $6.8 million for the same period in 2024, reflecting an increase of $4.6 million[179] - Direct costs for the KPL-387 program were $25.0 million for the nine months ended September 30, 2025, compared to $9.5 million in 2024, an increase of 163.2%[192] Collaboration and Licensing Agreements - The company entered into a license agreement with Genentech in August 2022, granting exclusive worldwide rights to develop and commercialize vixarelimab and related antibodies[62] - The Company received an upfront payment of $80,000 under the Genentech License Agreement, with additional cash payments totaling $35,000 received in 2023 and 2024 for development milestones[63][66]. - As of September 30, 2025, the Company is eligible to receive approximately $600,000 in contingent payments under the Genentech License Agreement, with about $570,000 remaining[63][66]. - The Company recognized $5,261 in collaboration revenue under the Genentech License Agreement during the nine months ended September 30, 2024, primarily due to a $5,000 development milestone[68]. - The Company entered into two Huadong Collaboration Agreements in February 2022, receiving a total upfront cash payment of $22,000, which included $12,000 for ARCALYST and $10,000 for mavrilimumab[69][71]. - Following a regulatory milestone in 2024, the Company received an additional cash payment of $20,000 from Huadong in the first quarter of 2025[72]. - The Company is eligible to receive up to approximately $50,000 in contingent sales-based milestone payments for ARCALYST, all of which remain outstanding as of September 30, 2025[72]. - Under the Biogen Agreement, the Company is obligated to make payments of up to $179,000 upon achieving specified clinical and regulatory milestones, with $165,000 remaining as of September 30, 2025[85]. - The Company has recognized $10,000 of collaboration revenue under the mavrilimumab Huadong Collaboration Agreement during the year ended December 31, 2022, prior to its termination in April 2025[77]. - As of September 30, 2025, $31,811 of the transaction price is recorded in non-current deferred revenue related to the ARCALYST Huadong Collaboration Agreement[82]. - The Company did not recognize any revenue under the ARCALYST Huadong Collaboration Agreement during the three and nine months ended September 30, 2025[82]. Expenses - Operating expenses for the three months ended September 30, 2025, totaled $156,834, compared to $121,872 for the same period in 2024, reflecting a 29% increase[131] - Selling, general and administrative expenses were $49.1 million for the three months ended September 30, 2025, an increase of $2.7 million from $46.4 million in the same period of 2024[183] - Selling, general and administrative expenses increased to $139.5 million for the nine months ended September 30, 2025, from $127.5 million in 2024, an increase of 9.5%[197] - Collaboration expenses increased to $63.3 million for the three months ended September 30, 2025, compared to $29.3 million for the same period in 2024, reflecting a rise of $34.0 million[176] - Collaboration expenses rose to $159.5 million for the nine months ended September 30, 2025, compared to $80.1 million in 2024, marking a 99.0% increase[190] - The Company recognized $63,282 and $159,446 in expenses related to the profit-sharing agreement with Regeneron for the three and nine months ended September 30, 2025, respectively, compared to $29,152 and $79,218 for the same periods in 2024[96] Tax and Regulatory - The income tax provision for the three months ended September 30, 2025 was $8,722, compared to $5,492 for the same period in 2024[108][109] - The company recorded an income tax provision of $20.8 million for the nine months ended September 30, 2025, compared to $15.1 million in 2024, an increase of 37.5%[198] - The company recorded deferred tax assets due to intra-entity transfers, representing the difference between stepped-up tax bases and book bases for financial statement purposes[122] - The FDA granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis in October 2025[137] - ARCALYST received FDA approval in March 2021 for the treatment of recurrent pericarditis, with an estimated U.S. prevalent population of approximately 40,000 patients[136] Inventory and Cash Flow - As of September 30, 2025, total inventory was $46,423, an increase from $31,218 as of December 31, 2024, reflecting a 48.6% rise[47] - The cost of goods sold for the three months ended September 30, 2025, was $20.3 million, a slight increase of $0.1 million from $20.1 million in the same period of 2024[175] - Cost of goods sold increased to $56.7 million for the nine months ended September 30, 2025, from $43.0 million in the same period of 2024, representing a 31.9% increase[188] - Net cash provided by operating activities was $84.1 million for the nine months ended September 30, 2025, compared to $6.9 million in 2024, an increase of 1,116.5%[204] - Net cash used in investing activities increased to $118.2 million for the nine months ended September 30, 2025, from $27.6 million in 2024, a rise of 328.6%[205] Strategic Focus - The company is focused on developing novel therapies for cardiovascular diseases, indicating a strategic emphasis on unmet medical needs in this area[29] - The company operates as a single segment focused on developing therapies for cardiovascular diseases with significant unmet medical needs[129] - The company expects to incur significant expenses related to the commercialization of ARCALYST and the advancement of product candidates through clinical development[207] - The company plans to conduct a supplemental Phase 2 transition study for KPL-387 to evaluate dosing regimens transitioning from standard therapies[137] Internal Controls - There were no changes in internal control over financial reporting during the three months ended September 30, 2025, that materially affected internal control[219] - Key areas of focus include accrued research and development expenses, revenue recognition, uncertain tax positions, and realizability of deferred tax assets[220]