Summary of Kiniksa Pharmaceuticals International (KNSA) Conference Call Company Overview - Kiniksa Pharmaceuticals is focused on developing novel therapies for unmet medical needs, particularly in cardiovascular indications, with a leadership position in the recurrent pericarditis market through its product Arcalist [5][6][10]. Financial Performance - Kiniksa increased its net revenue guidance for 2025 to between $590 million and $605 million, reflecting strong commercial performance [5][7]. - In Q1 2025, the company achieved profitability with net revenues of $137.8 million, a 75% year-over-year increase [7][17]. - Cash reserves reached $268 million, providing the company with the flexibility to invest in future growth opportunities [6][47]. Product Development - Kiniksa is advancing its clinical portfolio, particularly with KPL-387, a monoclonal antibody targeting the IL-1 signaling pathway for recurrent pericarditis [11][12]. - The Phase 2/3 clinical trial for KPL-387 is expected to initiate in mid-2025, with data readout anticipated in the second half of 2026 [5][17]. - The trial design includes a dose-focusing portion and a pivotal trial, allowing for a seamless transition between phases [14][42]. Market Penetration and Growth Strategy - Kiniksa has achieved approximately 13% penetration in the target population of patients with multiple recurrences of pericarditis, which is estimated at 14,000 patients [10][22]. - The company is focused on educating physicians about Arcalist and its benefits, which is expected to enhance prescribing rates [22][23]. - The average duration of therapy for patients has increased from 27 months to 30 months, indicating a growing recognition of recurrent pericarditis as a chronic condition [8][33]. Commercial Performance - The commercial team has successfully expanded the prescriber base, with around 300 new prescribers in Q1 2025, bringing the total to over 3,150 [7][8]. - Approximately 15% of patients prescribed Arcalist are treated during their first recurrence, with 85% on two or more recurrences [9][30]. - The payer approval rate for Arcalist exceeds 90%, indicating strong reimbursement support [31][32]. Clinical Insights - The clinical trial for KPL-387 aims to establish a monthly dosing regimen, with a focus on safety, tolerability, and efficacy [12][41]. - The primary efficacy endpoint for the pivotal trial will be the time to first adjudicated pericarditis recurrence [15][16]. - The company emphasizes the importance of timely diagnosis and treatment to improve patient outcomes and quality of life [27][30]. Future Outlook - Kiniksa is optimistic about its growth trajectory, with plans to leverage its strong financial position for future investments in both internal development and potential external opportunities [17][47]. - The company aims to bring KPL-387 to market by 2028-2029, enhancing its treatment options for patients with recurrent pericarditis [16][17]. Conclusion - Kiniksa Pharmaceuticals is well-positioned for future success, with a robust commercial performance, a promising clinical pipeline, and a strong financial foundation to support its growth initiatives [17][47].

Core Viewpoint - Kiniksa Pharmaceuticals is advancing its clinical trial for KPL-387, a monoclonal antibody targeting recurrent pericarditis, with a Phase 2/3 trial set to begin in mid-2025 and Phase 2 data expected in the second half of 2026 [1][2][3] Group 1: Clinical Trial Details - The Phase 2/3 clinical trial will evaluate the efficacy and safety of KPL-387 administered subcutaneously in patients with recurrent pericarditis, consisting of a dose-focusing portion, a pivotal portion, and long-term extensions [3][4] - The dose-focusing portion will enroll approximately 80 participants, randomized to receive different dosing regimens of KPL-387, with the primary efficacy endpoint being time to treatment response at Week 24 [4] - Following the dose-focusing portion, approximately 85 patients will be enrolled in the pivotal portion, which includes a single-blind run-in period followed by a double-blind randomized withdrawal period [5][6] Group 2: Drug Profile and Mechanism - KPL-387 is a fully human IgG2 monoclonal antibody that binds to the human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of IL-1α and IL-1β cytokines [9][10] - The drug aims to provide a monthly dosing option via a single subcutaneous injection in a liquid formulation, potentially expanding treatment options for recurrent pericarditis patients [10] Group 3: Company Overview - Kiniksa Pharmaceuticals focuses on developing novel therapies for diseases with unmet needs, particularly in cardiovascular indications, and aims to improve the lives of patients suffering from debilitating diseases [8]

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 [2] Upcoming Events - Kiniksa will present at the Jefferies 2025 Global Healthcare Conference on June 5 at 12:50 p.m. Eastern Time [3] - The company will also participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 10 at 8:00 a.m. Eastern Time, featuring a fireside chat [3] - Live webcasts of Kiniksa's presentations will be available on the company's website, with replays accessible approximately 48 hours after the events [1]

Group 1 - The biotech forum has seen significant discussions around covered call opportunities in recent quarters, indicating a focus on options trading strategies within the sector [1] - Kiniksa Pharmaceuticals (NASDAQ: KNSA) has experienced a notable increase in share price over the past week, suggesting positive market sentiment and potential trading opportunities for investors [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions and weekly market commentary, which may attract investors looking for insights and trading ideas [2]

– Pearce joins NHL Hall-of-Famer, Henrik Lundqvist, to educate patients and caregivers about the importance of accurate and early diagnosis of recurrent pericarditis, a chronic autoinflammatory disease of the heart that is often underdiagnosed or misdiagnosed – LONDON, April 30, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular in ...

Financial Performance - Total revenue for Q1 2025 was $137.785 million, a 72.5% increase from $79.858 million in Q1 2024[23] - Product revenue for Q1 2025 reached $137.785 million, compared to $78.885 million in Q1 2024, indicating strong growth in product sales[23] - Net income for Q1 2025 was $8.539 million, a significant improvement from a net loss of $17.704 million in Q1 2024[23] - For the three months ended March 31, 2025, the company reported net product revenue of $137,785, a 74.5% increase from $78,885 in the same period of 2024[45] - The net income for the three months ended March 31, 2025, was $8.5 million, a turnaround from a net loss of $17.7 million in the prior year[130] - The basic net income per share for the three months ended March 31, 2025, was $0.12, while the diluted net income per share was $0.11, compared to a basic and diluted loss per share of $(0.25) in 2024[102] Assets and Liabilities - Total current assets increased to $355.907 million as of March 31, 2025, up from $331.799 million at the end of 2024[21] - Total assets rose to $599.326 million as of March 31, 2025, compared to $580.553 million at the end of 2024[21] - Total liabilities decreased slightly to $141.837 million as of March 31, 2025, from $142.117 million at the end of 2024[21] - Shareholders' equity increased to $457.489 million as of March 31, 2025, up from $438.436 million at the end of 2024[21] - Cash and cash equivalents at the end of Q1 2025 were $157.132 million, down from $183.581 million at the end of 2024[27] - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $268,340, indicating a strong liquidity position[36] Operating Expenses - Operating expenses totaled $124.5 million, up from $96.4 million in 2024, primarily driven by increased collaboration expenses and selling, general, and administrative costs[130] - Research and development expenses for Q1 2025 were $19.325 million, a decrease from $26.334 million in Q1 2024[23] - Selling, general and administrative expenses rose to $43.5 million in Q1 2025, compared to $38.7 million in Q1 2024, an increase of $4.8 million[181] - Collaboration expenses increased to $43.8 million in Q1 2025 from $20.8 million in Q1 2024, a rise of $23.0 million[174] Cash Flow - Net cash provided by operating activities for Q1 2025 was $22.324 million, compared to $3.987 million in Q1 2024[27] - The company incurred net cash used in investing activities of $51.5 million in Q1 2025, a significant change from net cash provided of $25.5 million in Q1 2024, attributed to cash and short-term investment portfolio management[189] Revenue Recognition and Agreements - Under the Genentech License Agreement, the company received an upfront payment of $80,000 and is eligible for approximately $600,000 in contingent payments, with $570,000 remaining as of March 31, 2025[64] - The company received a total upfront cash payment of $22,000 under the Huadong Collaboration Agreements, with an additional $20,000 received in the first quarter of 2025 following a regulatory milestone[72] - The company has recognized $0.2 million of revenue from the $32.0 million transaction price under the ARCALYST license agreement as of March 31, 2025[148] - The Company recognized $10,000 of collaboration revenue during the year ended December 31, 2022, under the mavrilimumab Huadong Collaboration Agreement[78] Future Plans and Expectations - The company plans to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with data expected in the second half of 2026[135] - The company expects substantial research and development expenses in the coming years due to ongoing and planned clinical trials[160] - The company anticipates requiring additional capital for collaboration, licensing, or strategic transactions, as well as for product development and manufacturing if regulatory approvals are obtained[193] Regulatory and Market Challenges - The successful commercialization of ARCALYST and future products depends on favorable coverage and reimbursement from third-party payors, including governmental authorities and private health insurers[215] - Coverage and reimbursement barriers may significantly impact the demand and pricing of ARCALYST and any future product candidates[217] - The EU Regulation on Health Technology Assessment will apply from January 12, 2025, affecting the pricing and reimbursement process for new medicines and medical devices[218] - There is a risk that patients may discontinue ARCALYST treatment during transitions between specialty pharmacies, impacting business and financial results[214] Shareholder and Equity Information - Total unrecognized compensation expense related to outstanding unvested share option awards was $32,988, expected to be recognized over a weighted average remaining period of 2.31 years[57] - The 2018 Plan has 8,261,134 shares available for future grant as of March 31, 2025, following an increase of 2,900,642 shares on January 1, 2025[54] - The company has 10,992,948 share options outstanding as of March 31, 2025, with an average exercise price of $15.27[56]

Financial Data and Key Metrics Changes - Kynixa Pharmaceuticals reported net product revenue of $137.8 million in Q1 2025, representing a 75% year-over-year increase compared to Q1 2024 [6][10] - Operating expenses grew by 29% year-over-year, driven by costs associated with the growth of Arclis revenue and commercialization efforts [16] - The company achieved a net income of $8.5 million in Q1 2025, a significant improvement from a net loss of $17.7 million in the same quarter last year [17] Business Line Data and Key Metrics Changes - Arclis revenue increased by 75% year-over-year, driven by a substantial rise in active commercial patients [10][16] - The average duration of therapy for patients increased from approximately 27 months to 30 months, indicating a growing acceptance of the treatment among healthcare professionals [11][14] - The number of unique prescribers for Arclis grew to over 3,150, an increase of more than 1,150 from the same period in 2024 [12][14] Market Data and Key Metrics Changes - Approximately 70% of Arclis's payer mix is commercial, with recent changes to the Medicare Part D program improving patient affordability and contributing to a one-time increase in patients transitioning to paid therapy [11][12] - The gross-to-net ratio for Q1 2025 was 10.7%, down from 13.5% in Q1 2024, attributed to a shift in patient mix due to Medicare changes [42][44] Company Strategy and Development Direction - Kynixa is focused on expanding its commercial franchise with Arclis and advancing the KPL-387 program in recurrent pericarditis, with plans to initiate a Phase 2/3 clinical trial in mid-2025 [7][20] - The company aims to provide additional treatment options for patients with unmet needs, emphasizing the importance of long-term therapy for recurrent pericarditis [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong performance and ability to build on momentum throughout 2025, highlighting the effectiveness of their commercial strategies [6][20] - The management acknowledged the challenges posed by specialty drug headwinds but noted that these were outweighed by strong growth in prescribers and patient adherence [10][11] Other Important Information - Kynixa ended Q1 2025 with a cash balance of $268.3 million, indicating a positive cash flow for the period [18] - The company is in the process of transferring Arclis manufacturing to Samsung Biologics in South Korea, which is expected to have an immaterial impact on costs [19] Q&A Session Summary Question: What is driving the increased duration of therapy? - Management noted that the increase is due to healthcare professionals' growing understanding of recurrent pericarditis as a multi-year disease and positive patient experiences with the therapy [23][25] Question: How many prescriptions are from first recurrence? - Approximately 15% of patients on Arclis are on their first recurrence, with 85% on two or more recurrences, indicating a broad utilization of the treatment [31][32] Question: What initiatives are being taken to increase the prescriber base? - The company is focused on targeted execution in the field, digital marketing initiatives, and educating physicians about the disease and treatment options [38][40] Question: What is the outlook for Medicare Part D patients? - The majority of Medicare Part D patients transitioning to commercial therapy were previously on the patient assistance program, and this shift is seen as a one-time event [58][60]

Core Viewpoint - Kiniksa Pharmaceuticals reported a quarterly earnings of $0.11 per share, significantly exceeding the Zacks Consensus Estimate of $0.02 per share, and showing a substantial improvement from a loss of $0.25 per share a year ago, indicating a strong earnings surprise of 450% [1] Financial Performance - The company achieved revenues of $137.79 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 7.35%, and reflecting a year-over-year increase from $79.86 million [2] - Over the last four quarters, Kiniksa Pharmaceuticals has exceeded consensus EPS estimates two times and topped consensus revenue estimates four times [2] Stock Performance - Kiniksa Pharmaceuticals shares have increased approximately 8.5% since the beginning of the year, contrasting with a decline of -6% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is $0.08 on revenues of $138.46 million, and for the current fiscal year, it is $0.59 on revenues of $571.35 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Kiniksa Pharmaceuticals belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a favorable outlook as the top 50% of Zacks-ranked industries tend to outperform the bottom 50% by more than 2 to 1 [8]

Financial Data and Key Metrics Changes - Kynixa Pharmaceuticals reported a net product revenue of $137.8 million in Q1 2025, representing a 75% year-over-year increase compared to Q1 2024 [7][11] - Operating expenses grew by 29% year-over-year, driven by cost of goods sold and SG&A expenses related to Arclis commercialization [17] - The company achieved a net income of $8.5 million in Q1 2025, a significant improvement from a net loss of $17.7 million in the same quarter last year [17] Business Line Data and Key Metrics Changes - Arclis revenue grew 75% year-over-year to $137.8 million, driven by an increase in active commercial patients [11][17] - The number of unique prescribers for Arclis increased to over 3,150, with a growth of more than 1,150 from the same period in 2024 [13][14] - The average duration of therapy for patients increased from approximately 27 months to 30 months, indicating a growing appreciation for the treatment's long-term benefits [12][15] Market Data and Key Metrics Changes - The company noted a one-time increase in patients due to federal changes in the Medicare Part D program, which improved patient affordability [12][13] - Approximately 70% of Arclis's payer mix is commercial, with the Medicare program changes leading to a bolus of patients converting to paid therapy [12][13] Company Strategy and Development Direction - Kynixa is focused on expanding its commercial franchise with Arclis and advancing the KPL-387 program in recurrent pericarditis, with plans to initiate a Phase 2/3 clinical trial in mid-2025 [9][20] - The company is dedicated to helping as many patients as possible with Arclis and aims to bring additional treatment options to patients with unmet needs [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong performance and ability to build on momentum throughout 2025 [7][20] - The management highlighted the importance of understanding recurrent pericarditis as a multi-year disease, which has influenced prescribing practices [12][27] Other Important Information - Kynixa ended Q1 2025 with a cash balance of $268.3 million, indicating a net cash flow of approximately $25 million for the period [18] - The company is in the process of transferring Arclis manufacturing to Samsung Biologics in South Korea, which is expected to have an immaterial impact on cost of goods sold [19] Q&A Session Summary Question: What is driving the increased usage and patient experience feedback? - Management noted that the increase in duration is driven by healthcare professionals' understanding of the chronic nature of the disease and positive patient experiences with therapy [23][25][27] Question: How many prescriptions are from first recurrence and R&D cost trends? - Approximately 15% of patients on Arclis are on their first recurrence, with the majority on two or more recurrences. R&D costs have declined but are expected to remain stable moving forward [31][32][34] Question: What initiatives are being taken to increase the prescriber base? - The company is focused on targeted execution in the field and digital marketing initiatives to educate physicians about Arclis and its benefits [38][40][41] Question: How many new physicians were driven by Medicare Part D? - The majority of Medicare Part D patients were historic patients transitioning from free goods to commercial therapy, not new prescribers [60][62] Question: Will the trial for KPL-387 resemble Arclis's pivotal study? - The company is not sharing specific details about the KPL-387 trial design at this time but is moving forward with regulatory interactions [55][56]

Revenue Performance - ARCALYST (rilonacept) Q1 2025 net product revenue was $137.8 million, representing a 75% year-over-year growth[1]. - Total revenue for Q1 2025 was $137.8 million, compared to $79.9 million for Q1 2024[10]. - Kiniksa expects 2025 ARCALYST net product revenue to be between $590 million and $605 million, up from previous guidance of $560 million to $580 million[10]. Financial Results - Net income for Q1 2025 was $8.5 million, compared to a net loss of $17.7 million for Q1 2024[10]. - Total operating expenses for Q1 2025 were $124.5 million, compared to $96.4 million for Q1 2024[10]. Cash and Investments - As of March 31, 2025, Kiniksa had $268.3 million in cash, cash equivalents, and short-term investments, with no debt[10]. - Cash, cash equivalents, and short-term investments increased to $268,340,000 as of March 31, 2025, up from $243,627,000 on December 31, 2024, representing a growth of 10.5%[28]. - Working capital rose to $258,640,000, an increase of 11.9% from $231,178,000 at the end of 2024[28]. Asset and Equity Growth - Total assets increased to $599,326,000, reflecting a growth of 3.0% from $580,553,000 as of December 31, 2024[28]. - The accumulated deficit decreased to $(512,604,000) from $(521,143,000), indicating an improvement in financial position[28]. - Total shareholders' equity increased to $457,489,000, up 4.4% from $438,436,000 at the end of 2024[28]. Clinical Development - Average total duration of ARCALYST therapy in recurrent pericarditis increased to approximately 30 months, up from 27 months at the end of Q4 2024[5]. - KPL-387 Phase 2/3 clinical trial in recurrent pericarditis is on track to initiate in mid-2025, with Phase 2 data expected in 2H 2026[1]. Operational Considerations - The company continues to monitor potential implications of tariffs on pharmaceuticals imported into the United States[10]. - Kiniksa plans to transfer drug substance manufacturing for ARCALYST to Samsung Biologics in South Korea, expecting any future impact on gross margin to be immaterial[10].