Kiniksa Pharmaceuticals International (KNSA) 2025 Conference June 05, 2025 12:50 PM ET Speaker0 Alright. Okay. Good afternoon. Welcome to twenty twenty five Jefferies Global Healthcare Conference. My name is Roger Sung, one of the seniors cover SimiCA Biotech in The US. It is my pleasure to introduce our next printing company, Connexa, and then we have the chief commercial chief commercial officer Ross and then chief medical officer John. So, they will do a normal corporate presentation and then we'll save ...

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]