ARCALYST Performance and Market - ARCALYST has generated over $1 billion in revenue since its launch[7] - Expected 2025 ARCALYST revenue is projected to be between $625 million and $640 million[7, 51] - ARCALYST has achieved approximately 15% penetration into the target population of recurrent pericarditis patients as of Q2 2025[7, 23, 29] - Approximately 80% of ARCALYST prescriptions are for patients with ≥3rd recurrence[23] - Approximately 20% of ARCALYST prescriptions are for patients in their 1st recurrence[23] - Payer approval for ARCALYST exceeds 90% of completed cases[28] - Approximately 45% of patients restarted ARCALYST therapy following initial discontinuation within ~8 weeks[37, 40] - The average total duration of ARCALYST therapy is approximately 30 months[28, 40] Financial Position - Kiniksa reported Q2 2025 cash reserves of approximately $308 million[8] - Kiniksa's operating plan is expected to remain cash flow positive on an annual basis[7, 78] - ARCALYST net sales for Q2 2025 were $156.8 million, compared to $103.4 million in Q2 2024[77] KPL-387 Development - A Phase 2/3 trial for KPL-387 in recurrent pericarditis has been initiated, with Phase 2 dose-focusing data expected in the second half of 2026[8]

[Financial & Operational Highlights](index=1&type=section&id=Financial%20%26%20Operational%20Highlights) 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](index=1&type=chunk)[3](index=3&type=chunk) - The cash balance increased by **$39.4 million** during the quarter, reaching **$307.8 million** as of June 30, 2025[1](index=1&type=chunk)[9](index=9&type=chunk) [Portfolio Execution](index=1&type=section&id=Portfolio%20Execution) Portfolio execution is driven by strong ARCALYST commercial performance and active advancement of KPL-387 and KPL-1161 in the clinical pipeline [ARCALYST (rilonacept)](index=1&type=section&id=ARCALYST%20%28rilonacept%29) 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](index=4&type=chunk) - The average total duration of ARCALYST therapy for recurrent pericarditis reached approximately **30 months** by the end of Q2 2025[4](index=4&type=chunk) - As of Q2 2025 end, approximately **15%** of the target 14,000 patients with multiple recurrences were actively receiving ARCALYST treatment[4](index=4&type=chunk) [KPL-387](index=2&type=section&id=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](index=5&type=chunk) - 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](index=3&type=chunk)[5](index=5&type=chunk) [KPL-1161](index=2&type=section&id=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](index=6&type=chunk) - KPL-1161 is being developed with a target profile of **quarterly subcutaneous (SC) dosing**[6](index=6&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Kiniksa achieved significant revenue growth and transitioned to profitability in Q2 2025, maintaining a strong balance sheet with no debt [Financial Results (Q2 2025)](index=2&type=section&id=Financial%20Results%20%28Q2%202025%29) 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](index=9&type=chunk) [Financial Position (as of June 30, 2025)](index=2&type=section&id=Financial%20Position%20%28as%20of%20June%2030%2C%202025%29) 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](index=9&type=chunk) [Financial Guidance](index=2&type=section&id=Financial%20Guidance) 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](index=3&type=chunk)[9](index=9&type=chunk) - The company expects its current operating plan to remain **cash flow positive** on an annual basis[9](index=9&type=chunk) [Appendix: Financial Statements](index=6&type=section&id=Appendix%3A%20Financial%20Statements) This appendix provides unaudited consolidated statements of operations and selected balance sheet data for specified periods [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) 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](index=7&type=section&id=Selected%20Consolidated%20Balance%20Sheet%20Data) 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 |

Core Insights - Kiniksa Pharmaceuticals reported a strong commercial performance in Q2 2025, with ARCALYST net product revenue reaching $156.8 million, reflecting a 52% year-over-year growth [1][2][8] - The company has raised its 2025 ARCALYST net sales guidance to between $625 million and $640 million, up from a previous range of $590 million to $605 million [2][13] - Kiniksa is advancing its clinical pipeline, with the initiation of the Phase 2/3 clinical trial for KPL-387 in recurrent pericarditis, expecting data in the second half of 2026 [4][15] Financial Performance - Total revenue for Q2 2025 was $156.8 million, compared to $108.6 million in Q2 2024 [8][22] - The net income for Q2 2025 was $17.8 million, a significant improvement from a net loss of $3.9 million in Q2 2024 [13][22] - Operating expenses for Q2 2025 totaled $136.6 million, up from $108.7 million in Q2 2024, with collaboration expenses increasing due to ARCALYST profitability [8][22] Product and Pipeline Updates - ARCALYST has been prescribed by over 3,475 prescribers for recurrent pericarditis, with an average treatment duration of approximately 30 months [7] - As of Q2 2025, about 15% of the target 14,000 multiple-recurrence patients are actively receiving ARCALYST treatment [7] - KPL-387 is in the dose-focusing portion of its Phase 2/3 trial, with plans for a pivotal trial to follow [4][15] Cash Position - Kiniksa's cash balance increased by $39.4 million in Q2 2025, reaching $307.8 million, with no debt reported [1][13][23] - The company expects to maintain a cash flow positive operating plan on an annual basis [13]

Core Viewpoint - Kiniksa Pharmaceuticals International, plc will host a conference call on July 29, 2025, to discuss its second quarter 2025 financial results and recent portfolio execution [1]. Group 1: Conference Call Details - The conference call will take place at 8:30 a.m. Eastern Time [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 call [2]. Group 2: Company Overview - Kiniksa is a biopharmaceutical company focused on developing therapies for debilitating diseases, particularly in cardiovascular indications [3]. - The company aims to discover, acquire, develop, and commercialize novel therapies for diseases with unmet needs [3]. - Kiniksa's portfolio is based on strong biological rationale or validated mechanisms, offering potential for differentiation in the market [3].

ARCALYST Performance and Market - Kiniksa expects ARCALYST net product revenue of $220 million to $230 million in 2023, representing approximately 84% growth at the midpoint[13,51] - ARCALYST has achieved only about 5% penetration of the target recurrent pericarditis population as of the end of 2022[13] - Approximately 14,000 recurrent pericarditis patients in the U S suffer from persistent underlying disease[28] - The addressable U S opportunity for ARCALYST is estimated to be approximately 14,000 patients, with about 7,000 new patients entering the target pool annually[33,36] - In Q2 2023, ARCALYST product revenue reached $54.5 million, representing approximately 100% year-over-year growth[38] Financial Position and Licensing Agreements - Kiniksa's cash position was $185 million as of Q2 2023[13,21] - The company's cash runway extends into at least 2027, supported by a profitable ARCALYST collaboration and revenue from out-licensing agreements[13,21] - Kiniksa received a $22 million upfront payment from Huadong Medicine and is eligible for up to approximately $640 million in milestones and royalties[24] - Kiniksa has received $100 million in upfront and near-term payments from the Genentech transaction, and is eligible for up to approximately $600 million in milestones[24] KPL-404 Development - KPL-404, a potentially best-in-class asset, is currently in a Phase 2 study for rheumatoid arthritis[14,18] - The Phase 2 trial for KPL-404 in rheumatoid arthritis is a multiple-ascending-dose study evaluating PK and safety, transitioning into a parallel dose efficacy portion[72]

Group 1 - The article does not provide specific insights or analysis on any companies or industries [1]

Industry Overview - The biotech industry has shown resilience amid global trade tensions, with ongoing geopolitical issues presenting challenges, yet the demand for innovative medical treatments remains strong [1] - Strategic collaborations and acquisitions are increasingly common as large pharma and biotech companies seek to expand their product portfolios and pipelines, particularly in the context of AI-driven drug discovery [2][9] - The Zacks Biomedical and Genetics industry is currently ranked 86, placing it in the top 35% of over 246 Zacks industries, indicating a decent outlook driven by consistent demand for medical advancements [15] Market Trends - The focus on high-profile drug performance and innovative pipeline development is critical, with significant R&D expenditures required to create breakthrough treatments [6] - Successful commercialization is essential for drug uptake, often leading smaller biotech firms to collaborate with larger companies for shared sales or royalties [7] - The recent emphasis on AI technology for drug discovery is expected to attract further investment into the biotech sector [11] Company Performance - Exelixis, Inc. (EXEL) is positioned well with its lead drug, Cabometyx, which is gaining traction in the oncology market, and its shares have surged 31% year to date [35][36] - Verona Pharma (VRNA) has seen a 94.8% increase in shares year to date, driven by the uptake of its drug Ohtuvayre for COPD, with further growth anticipated [24] - Alkermes (ALKS) is benefiting from strong sales of its proprietary drugs and has a Zacks Rank of 1, with EPS estimates for 2025 rising to $1.79 [26][27] - Immunocore Holdings (IMCR) focuses on TCR bispecific immunotherapies and has gained 11.4% year to date, with ongoing studies expected to enhance its market position [30][32] - Kiniska Pharmaceuticals (KNSA) is experiencing growth with its FDA-approved drug Arcalyst and has seen a 37.7% increase in shares [39][40]

Group 1 - Kiniksa Pharmaceuticals (NASDAQ: KNSA) has shown strong performance this year, with the stock advancing slightly more than 40% since the last update [2] - The positive performance is attributed to significant changes in the company's pipeline and the development of next-generation IL-1 therapies [2] Group 2 - The Growth Stock Forum provides a model portfolio of 15-20 stocks, a top picks list of up to 10 stocks expected to perform well, and trading ideas targeting short-term and medium-term moves [2]

Summary of Kiniksa Pharmaceuticals International (KNSA) FY Conference Call Company Overview - Kiniksa Pharmaceuticals is a growth-oriented, well-capitalized organization focused on addressing unmet needs in the cardiovascular space, particularly recurrent pericarditis [5][6] - The company has a commercial stage product, Arclis, which was approved in 2021 and has shown significant revenue growth [5][6] Financial Performance - Kiniksa increased its revenue guidance for 2025 to between $590 million and $605 million [5] - The company reported significant growth in Q1 2025 compared to Q4 2024, driven by three key factors: an increase in prescriber base, longer durations of therapy, and the impact of the Medicare Part D redesign [10][11] Product Performance - Arclis has seen an increase in the prescriber base, with approximately 3,150 prescribers, including around 300 new prescribers in Q1 2025 [11][24] - The average duration of therapy for Arclis has increased from 27 months to 30 months [11] - The Medicare Part D redesign has improved affordability for patients, contributing to a transition of patients from free goods to commercial drugs [12][10] Clinical Development - Kiniksa is advancing its clinical portfolio, including KPL 387, a monoclonal antibody for recurrent pericarditis, which is set to enter a phase 2/3 clinical study in mid-2025 [6][46] - KPL 1161, another monoclonal antibody, is in IND enabling studies with undisclosed indications [6] Market Dynamics - The company is targeting a prescriber base of approximately 25,000 cardiologists and rheumatologists, indicating significant room for growth [24][26] - The treatment landscape for recurrent pericarditis is evolving, with more centers of excellence focusing on the disease [24] Manufacturing Strategy - Kiniksa is transitioning the manufacturing of Arclis to Samsung Biologics in South Korea, which is part of a planned technology transfer [40][41] - The company anticipates that potential tariffs on imported drug substances will have an immaterial impact on gross margins [42][43] Future Outlook - Kiniksa aims to continue innovating and providing treatment options for recurrent pericarditis, with a focus on expanding the use of Arclis and advancing its pipeline products [71][72] - The company reported a cash balance of approximately $268 million, indicating strong financial health and capacity for future growth [72] Key Takeaways - Kiniksa Pharmaceuticals is well-positioned in the recurrent pericarditis market with a strong product pipeline and financial backing - The company is actively expanding its prescriber base and improving patient access through strategic initiatives like the Medicare Part D redesign - Future clinical developments, including KPL 387, are expected to enhance treatment options for patients suffering from recurrent pericarditis [6][71]

Financial Performance & Growth - Kiniksa expects ARCALYST net revenue for 2025 to be between $590 million and $605 million[7, 34] - The company's Q1 2025 net revenue grew by approximately 75% year-over-year[13] - Kiniksa's Q1 2025 cash reserves are approximately $268 million[8, 35] - ARCALYST has achieved only about 13% penetration into its target population as of the end of Q4 2024[7, 18] Clinical Development - Kiniksa is developing KPL-387 for recurrent pericarditis, with a Phase 2/3 trial expected to begin in mid-2025 and Phase 2 data expected in the second half of 2026[7, 34] - The company is conducting IND-enabling activities with KPL-1161[7, 34] - KPL-387 is a fully human IgG2 monoclonal antibody that binds to IL-1R1, inhibiting IL-1α & IL-1β cytokine-mediated signaling[22] Commercial Strategy - Kiniksa's strategy focuses on driving future growth through innovation and execution, maximizing the current commercial opportunity for ARCALYST, and advancing its clinical portfolio[34] - The company aims to support the creation of an efficient network of care with regional centers of excellence and educate on data related to duration of disease and treatment to support longer-term persistence on ARCALYST[18]