Summary of Kiniksa Pharmaceuticals International Conference Call Company Overview - Kiniksa Pharmaceuticals is a growth-oriented organization focused on developing novel therapies for debilitating diseases, particularly recurrent pericarditis [3][4][19] - The company has established leadership in the recurrent pericarditis market with its product ARCALYST, generating over $1 billion in net product revenue since FDA approval [3][4] Financial Performance - Kiniksa increased its net revenue guidance for 2025 to between $670 million and $675 million, reflecting strong commercial performance [4][19] - In Q3, Kiniksa reported $180.9 million in net product revenue for ARCALYST, a 61% year-over-year increase compared to Q3 2024 [5][19] - The company maintains a strong financial position with over $350 million in cash reserves [4][20] Market Penetration and Growth Opportunities - Kiniksa has only penetrated 15% of the multiple recurrence population, indicating significant growth potential [3][6] - Approximately 80% of ARCALYST prescriptions are for patients with two or more recurrences, while 20% are for patients on their first recurrence, up from 15% the previous year [5][6] - The company is focused on educating healthcare professionals about the chronic nature of recurrent pericarditis to improve patient retention on treatment [28][29] Pipeline Development - KPL-387, a new drug in development for recurrent pericarditis, received orphan drug designation from the FDA and is currently in a phase 2/3 clinical trial [4][19] - The phase 2 portion of the trial is expected to read out in the second half of 2026, with the goal of launching KPL-387 by 2028-2029 [4][18] - KPL-387 is designed for monthly dosing and aims to provide a highly efficacious and well-tolerated treatment option [14][35] Physician and Patient Engagement - Kiniksa is working to ensure a positive prescribing experience for physicians, which is expected to lead to repeat prescriptions and peer-to-peer education [8][9] - The company has expanded the number of specialized care centers for pericardial diseases from 2 to 18 in collaboration with the American Heart Association [9][10] - Market research indicates that over 75% of patients would choose KPL-387 as their preferred treatment option, and more than 90% of healthcare professionals would likely prescribe it [11][35] Conclusion - Kiniksa is well-positioned for future success with a robust strategy to maximize the commercial opportunity of ARCALYST and advance its clinical portfolio [19][20] - The company is committed to addressing the unmet needs of patients suffering from recurrent pericarditis through innovative therapies and strong market engagement strategies [3][4][19]

Company Overview - Kiniksa Pharmaceuticals International, plc is a biopharmaceutical company focused on improving the lives of patients with debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet needs, particularly in cardiovascular indications [3] Upcoming Event - Kiniksa management will present at the Jefferies Global Healthcare Conference in London on November 17, 2025, at 2:30 p.m. GMT (9:30 a.m. ET) [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]

Core Insights - The article discusses the author's investment journey, emphasizing a value-investing strategy focused on small to mid-cap stocks [1] Group 1: Investment Strategy - The company adopts a value-investing strategy, prioritizing not overpaying for stocks to mitigate risks associated with overpriced equities [1] - Stocks are typically held until growth prospects diminish or the price-to-earnings ratio justifies a sale [1] Group 2: Community Engagement - The motivation for writing on Seeking Alpha is to share insights and analyses with a broader audience, aiming to build a community of like-minded investors [1]

Financial 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]

Core Insights - Kiniksa Pharmaceuticals International, plc reported quarterly earnings of $0.23 per share, missing the Zacks Consensus Estimate of $0.33 per share, representing an earnings surprise of -30.30% [1] - The company posted revenues of $180.86 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 8.91% and showing a year-over-year increase from $112.21 million [2] - The stock has gained approximately 105.3% since the beginning of the year, significantly outperforming the S&P 500's gain of 16.9% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.42 on revenues of $175.84 million, and for the current fiscal year, it is $1.05 on revenues of $636.48 million [7] - The estimate revisions trend for Kiniksa Pharmaceuticals was favorable prior to the earnings release, resulting in a Zacks Rank 1 (Strong Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Kiniksa belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook for stocks within this sector [8] - Another company in the same industry, XOMA Royalty, is expected to report a quarterly loss of $0.02 per share, reflecting a year-over-year change of +94.9%, with revenues anticipated to be $12.59 million, up 74.8% from the previous year [9]

Financial Data and Key Metrics Changes - ARCALYST revenue grew to $180.9 million in Q3 2025, representing a 61% year-over-year increase and a $24 million increase from the previous quarter [7][17] - Net income for Q3 2025 was $18.4 million, compared to a net loss of $12.7 million in the same quarter last year [17] - Operating expenses increased by 29% year-over-year to $156.8 million, primarily due to collaboration expenses related to ARCALYST [17] Business Line Data and Key Metrics Changes - The adoption of IL-1 inhibition with ARCALYST has driven significant revenue growth, with a 118% year-over-year increase in ARCALYST collaboration profit to $126.6 million [17] - The average duration of therapy for patients on ARCALYST increased to approximately 32 months, indicating higher patient satisfaction and retention [10][25] Market Data and Key Metrics Changes - The company reported that approximately 20% of ARCALYST prescriptions were written for patients following their first recurrence, indicating a shift in treatment patterns [7] - The total prescriber count for ARCALYST reached over 3,825, with more than 350 new prescribers added in Q3 2025 [10][48] Company Strategy and Development Direction - The company aims to maintain its market leadership in recurrent pericarditis through the continued growth of ARCALYST and the development of KPL-387, which has received orphan drug designation from the FDA [6][14] - The strategic focus includes evolving the treatment landscape for recurrent pericarditis and increasing education among healthcare professionals [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of ARCALYST, raising full-year net sales guidance to between $670 million and $675 million [5][12] - The management highlighted the importance of the recent ACC guidelines in promoting IL-1 pathway inhibition as a new standard of care, which is expected to further drive adoption [29][31] Other Important Information - The company maintained a strong cash position, with a cash balance of approximately $352.1 million, increasing by about $44 million in Q3 2025 [17] - The phase 2 dose-focusing portion of the KPL-387 trial is on track to report data in the second half of 2026 [16] Q&A Session Summary Question: Feedback on ARCALYST duration increase - Management noted positive feedback from both patients and healthcare professionals regarding the increased duration of therapy, with a significant reduction in event rates post-treatment [22][25] Question: Incorporation of updated ACC guidelines - The updated guidelines affirm the positioning of IL-1 pathway inhibition as a second-line treatment, which has been integrated into promotional efforts [28][30] Question: Growth dynamics for ARCALYST - The growth dynamics were attributed to increased prescriber confidence and awareness, aided by the ACC guidelines [41][48] Question: Drivers for KPL-387 phase 3 decision - The phase 2 study is designed to confirm the efficacy of the 300 mg subcutaneous dose, which is expected to be the primary focus for the phase 3 trial [42] Question: Increase in prescribers - The increase in prescribers was driven by greater confidence in ARCALYST as a treatment choice and targeted marketing efforts [46][50]

Financial Data and Key Metrics Changes - ARCALYST revenue grew to $180.9 million in Q3 2025, representing a 61% year-over-year increase and approximately $24 million growth over the previous quarter [16][6] - Operating expenses increased by 29% year-over-year to $156.8 million, primarily due to collaboration expenses linked to ARCALYST sales growth [16] - Net income for Q3 2025 was $18.4 million, compared to a net loss of $12.7 million in the same quarter last year [16] Business Line Data and Key Metrics Changes - The adoption of IL-1 and IL-1 inhibition for recurrent pericarditis has driven significant gains in active commercial patients and therapy duration [16] - The average duration of therapy for ARCALYST increased to approximately 32 months, indicating higher patient satisfaction and retention [9][24] Market Data and Key Metrics Changes - The company reported that only 15% of the multiple recurrence patient population has been penetrated, indicating substantial growth potential for ARCALYST [4] - Approximately 20% of ARCALYST prescriptions are now written for patients following their first recurrence, showing an increase in early treatment adoption [6] Company Strategy and Development Direction - Kiniksa Pharmaceuticals aims to maintain its market leadership in recurrent pericarditis through the continued growth of ARCALYST and the development of KPL-387, which has received orphan drug designation from the FDA [5][4] - The company is focused on evolving the treatment landscape for recurrent pericarditis by increasing education and driving the utilization of IL-1 inhibition as the new standard of care [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of ARCALYST, raising full-year net sales guidance to between $670 million and $675 million [4][12] - The management team highlighted the importance of continued education and support for healthcare professionals to enhance the adoption of ARCALYST [10] Other Important Information - The FDA granted KPL-387 orphan drug designation for the treatment of pericarditis, which includes recurrent pericarditis, enhancing its development prospects [5] - The company maintains a strong cash position, with a cash balance of approximately $352.1 million, indicating robust financial health [16] Q&A Session Summary Question: Feedback on ARCALYST duration increase - Management noted positive feedback from both patients and healthcare professionals regarding the efficacy and satisfaction of ARCALYST, with a significant reduction in event rates when treatment is maintained [20][24] Question: Incorporation of updated ACC guidelines - The updated guidelines affirm the use of IL-1 pathway inhibition as a second-line treatment, which Kiniksa has incorporated into its promotional materials to enhance physician awareness [25][28] Question: Growth dynamics for ARCALYST - The company reported a decrease in growth dynamics from 9.5% to 8.9% year-to-date, consistent with historical patterns influenced by industry dynamics [37] Question: Increase in prescribers - The company experienced the highest increase in prescribers since launch, with over 350 new prescribers in Q3, attributed to increased confidence and awareness of ARCALYST [41][42] Question: Restart rates for patients - Approximately 45% of patients who initially stop treatment with ARCALYST return to therapy, with a quick re-initiation process due to existing payer approvals [50][51] Question: Competitive landscape and upcoming data - Management acknowledged the anticipation of phase 2 data from a competitor but emphasized the long-term efficacy demonstrated by ARCALYST in managing recurrent pericarditis [54][56]

Financial Performance - ARCALYST Q3 2025 revenue reached $180.9 million, representing approximately 61% year-over-year growth[10] - The company raised full-year 2025 net revenue guidance to between $670 million and $675 million, up from the previous guidance of between $625 million and $640 million[10] - Total prescribers of ARCALYST exceeded 3,825 as of Q3 2025[20] - Repeat prescribers of ARCALYST were approximately 1,070 as of Q3 2025[20] - Cash, cash equivalents, and short-term investments amounted to approximately $352.1 million as of September 30, 2025[29] ARCALYST Market and Usage - Approximately 20% of ARCALYST prescriptions are for patients on their first recurrence of pericarditis[16] - The majority of ARCALYST prescribing continues to come from the 14,000 multiple recurrence population[16] - Average total duration of ARCALYST therapy is approximately 32 months[20] - Payer approval rate for ARCALYST is greater than 90% of completed cases[20] Pipeline Development - KPL-387 received US Orphan Drug Designation for pericarditis, with Phase 2 data expected in the second half of 2026[10]

Revenue Performance - ARCALYST (rilonacept) Q3 2025 net product revenue reached $180.9 million, reflecting a 61% year-over-year growth[1] - Total revenue for Q3 2025 was $180.9 million, compared to $112.2 million for Q3 2024, indicating significant growth[10] - Total revenue for the three months ended September 30, 2025, was $180.855 million, a 61% increase from $112.214 million in the same period of 2024[22] Income and Expenses - Net income for Q3 2025 was $18.4 million, a turnaround from a net loss of $12.7 million in Q3 2024[10] - Net income for the three months ended September 30, 2025, was $18.435 million, compared to a net loss of $12.693 million in the same period of 2024[22] - Total operating expenses for Q3 2025 were $156.8 million, up from $121.9 million in Q3 2024, including $63.3 million in collaboration expenses[10] - Operating expenses for the three months ended September 30, 2025, totaled $156.834 million, up from $121.872 million in the same period of 2024, reflecting a 28.7% increase[22] Cash and Assets - The cash balance increased by $44.3 million in Q3 2025, totaling $352.1 million, with no debt reported[10] - Cash, cash equivalents, and short-term investments rose to $352.102 million as of September 30, 2025, up from $243.627 million as of December 31, 2024, indicating a 44.7% increase[24] - Total assets as of September 30, 2025, increased to $712.333 million from $580.553 million as of December 31, 2024, representing a 22.7% growth[24] - Total shareholders' equity increased to $535.383 million as of September 30, 2025, compared to $438.436 million as of December 31, 2024, marking a 22.1% rise[24] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $62.244 million, down from $76.408 million in the same period of 2024, reflecting an 18.6% decrease[22] - KPL-387 has been granted Orphan Drug Designation for the treatment of pericarditis by the FDA[10] - Kiniksa plans to initiate the pivotal portion of the KPL-387 Phase 2/3 clinical trial after data from the dose-focusing portion is expected in the second half of 2026[10] Shareholder Information - The company reported a basic net income per share of $0.25 for the three months ended September 30, 2025, compared to a loss of $0.18 per share in the same period of 2024[22] - The company had a weighted average of 74,714,846 basic ordinary shares outstanding for the three months ended September 30, 2025, compared to 71,726,685 in the same period of 2024[22] Other Financial Metrics - The accumulated deficit as of September 30, 2025, was $476.337 million, an improvement from $521.143 million as of December 31, 2024[24] - Kiniksa's current operating plan is expected to remain cash flow positive on an annual basis[10] - The average total duration of ARCALYST therapy in recurrent pericarditis increased to approximately 32 months, compared to 27 months at the end of 2024[5] - The 2025 expected net product revenue for ARCALYST has been raised to between $670 million and $675 million, up from the previous guidance of $625 million to $640 million[3]

Core Insights - Kiniksa Pharmaceuticals reported a significant increase in net product revenue for ARCALYST, reaching $180.9 million in Q3 2025, which represents a 61% year-over-year growth [1][7] - The company raised its 2025 net sales guidance for ARCALYST to between $670 million and $675 million, up from a previous estimate of $625 million to $640 million [2][13] - KPL-387 received Orphan Drug Designation from the FDA for the treatment of pericarditis, indicating potential for expanded treatment options in this area [1][15] Financial Results - Total revenue for Q3 2025 was $180.9 million, compared to $112.2 million in Q3 2024 [7][22] - Net income for Q3 2025 was $18.4 million, a turnaround from a net loss of $12.7 million in Q3 2024 [13][22] - Cash balance increased by $44.3 million in Q3 2025, totaling $352.1 million as of September 30, 2025 [1][13] Portfolio Execution - The average total duration of ARCALYST therapy for recurrent pericarditis increased to approximately 32 months by the end of Q3 2025, up from 27 months at the end of 2024 [7] - Kiniksa is on track to report data from the Phase 2 dose-focusing portion of the KPL-387 Phase 2/3 trial in the second half of 2026 [2][7] - KPL-1161 is undergoing IND-enabling development activities, targeting quarterly subcutaneous dosing [5][16] Market Position - Over 3,825 prescribers have written ARCALYST prescriptions for recurrent pericarditis since its launch, indicating strong market adoption [7] - The company aims to enhance its IL-1α & IL-1β inhibition franchise with the development of KPL-387, potentially expanding its market penetration [2][15]