Kiniksa(KNSA) - 2025 Q2 - Quarterly Results

Financial & Operational Highlights Kiniksa reported strong Q2 2025 results, driven by ARCALYST revenue growth, raised full-year guidance, and initiated a pivotal clinical trial ARCALYST Net Product Revenue | Metric | Q2 2025 (USD) | YoY Growth | | :--- | :--- | :--- | | ARCALYST Net Product Revenue | $156.8 million | 52% | ARCALYST Net Product Revenue Guidance | Guidance | Previous (USD) | Updated (USD) | | :--- | :--- | :--- | | 2025 ARCALYST Net Product Revenue | $590 - $605 million | $625 - $640 million | - Initiated the pivotal Phase 2/3 clinical trial of KPL-387 for recurrent pericarditis, with Phase 2 data anticipated in the second half of 2026[1][3] - The cash balance increased by $39.4 million during the quarter, reaching $307.8 million as of June 30, 2025[1][9] Portfolio Execution Portfolio execution is driven by strong ARCALYST commercial performance and active advancement of KPL-387 and KPL-1161 in the clinical pipeline ARCALYST (rilonacept) ARCALYST demonstrates strong market penetration and sustained therapy duration in recurrent pericarditis patients - Since its launch, over 3,475 prescribers have written ARCALYST prescriptions for recurrent pericarditis[4] - The average total duration of ARCALYST therapy for recurrent pericarditis reached approximately 30 months by the end of Q2 2025[4] - As of Q2 2025 end, approximately 15% of the target 14,000 patients with multiple recurrences were actively receiving ARCALYST treatment[4] KPL-387 KPL-387 is actively recruiting for its Phase 2/3 trial, with data expected in late 2026 and potential market entry by 2028/2029 - Patient recruitment is underway for the dose-focusing portion of the Phase 2/3 clinical trial in recurrent pericarditis[5] - Data from the Phase 2 portion of the trial is expected in the second half of 2026, with potential market entry projected for the 2028/2029 timeframe[3][5] KPL-1161 KPL-1161 is undergoing IND-enabling development, targeting a convenient quarterly subcutaneous dosing profile - The company is conducting Investigational New Drug (IND)-enabling development activities for KPL-1161[6] - KPL-1161 is being developed with a target profile of quarterly subcutaneous (SC) dosing[6] Financial Performance Kiniksa achieved significant revenue growth and transitioned to profitability in Q2 2025, maintaining a strong balance sheet with no debt Financial Results (Q2 2025) Q2 2025 financial results show significant revenue growth and a shift to net income, driven by ARCALYST sales Q2 2025 Financial Metrics | Financial Metric | Q2 2025 (USD) | Q2 2024 (USD) | | :--- | :--- | :--- | | Total Revenue | $156.8 million | $108.6 million | | Total Operating Expenses | $136.6 million | $108.7 million | | Net Income (Loss) | $17.8 million | ($3.9 million) | - The increase in total operating expenses was primarily driven by a rise in collaboration expenses related to ARCALYST's profitability, which grew to $52.4 million from $30.0 million year-over-year[9] Financial Position (as of June 30, 2025) The company's financial position as of June 30, 2025, reflects a strong cash balance and no outstanding debt Selected Balance Sheet Data | Balance Sheet Item | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $307.8 million | $243.6 million | | Total Assets | $661.2 million | $580.6 million | | Total Shareholders' Equity | $495.0 million | $438.4 million | - As of June 30, 2025, Kiniksa had no debt[9] Financial Guidance Kiniksa raised its full-year 2025 ARCALYST revenue guidance and expects to remain cash flow positive annually - Raised 2025 ARCALYST net product revenue guidance to between $625 million and $640 million, up from the prior range of $590 million to $605 million[3][9] - The company expects its current operating plan to remain cash flow positive on an annual basis[9] Appendix: Financial Statements This appendix provides unaudited consolidated statements of operations and selected balance sheet data for specified periods Consolidated Statements of Operations This section presents the unaudited consolidated statements of operations for the three months ended June 30, 2025 and 2024 Consolidated Statements of Operations (Thousands USD) | Metric | Three Months Ended June 30, 2025 (Thousands USD) | Three Months Ended June 30, 2024 (Thousands USD) | | :--- | :--- | :--- | | Total revenue | $156,797 | $108,631 | | Product revenue, net | $156,797 | $103,394 | | Total operating expenses | $136,637 | $108,748 | | Cost of goods sold | $18,603 | $12,322 | | Collaboration expenses | $52,418 | $30,014 | | Research and development | $18,753 | $24,017 | | Selling, general and administrative | $46,863 | $42,395 | | Income (loss) from operations | $20,160 | ($117) | | Net income (loss) | $17,832 | ($3,908) | | Net income (loss) per share—diluted | $0.23 | ($0.06) | Selected Consolidated Balance Sheet Data This section provides selected unaudited consolidated balance sheet data as of June 30, 2025, and December 31, 2024 Selected Consolidated Balance Sheet Data (Thousands USD) | Balance Sheet Item | As of June 30, 2025 (Thousands USD) | As of December 31, 2024 (Thousands USD) | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $307,782 | $243,627 | | Working capital | $302,484 | $231,178 | | Total assets | $661,150 | $580,553 | | Total shareholders' equity | $495,007 | $438,436 |