KalVista Pharmaceuticals(KALV) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Sales of EKTERLY reached $13.7 million for the launch period through September 30, including $1.4 million recorded in July, indicating strong early demand [22][24] - Total operating expenses for the period were $59.7 million, comprising approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses [23] - Gross to net revenue came in toward the low end of the expected range, primarily due to lower copay utilization typical for this time of year [22] Business Line Data and Key Metrics Changes - The U.S. launch of EKTERLY has seen 937 start forms, representing over 10% of the HAE community, with rapid uptake across all patient segments [15][21] - The average number of cartons per shipment is on the high end of expected ranges, aligning with utilization among high-burden patients [22] - Patients refilling prescriptions are doing so every three to four weeks, compared to the typical three to four refills per year for most injectable therapies [17] Market Data and Key Metrics Changes - The approval footprint for EKTERLY continues to grow, with recent approvals in Australia and ongoing discussions for pricing and reimbursement in the U.K. and Japan [5][20] - Awareness levels among healthcare providers are exceptionally high, with 100% of tier one HCPs and 95% of all target HCPs reporting awareness of EKTERLY [16] Company Strategy and Development Direction - The company aims to establish EKTERLY as the foundational therapy for HAE treatment, focusing on aggressive execution and global expansion [24][25] - The strategy includes evaluating optimal access strategies in geographies where the company will not launch independently and completing more agreements for distribution [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in EKTERLY's potential to become the leading treatment for HAE, supported by strong early adoption and patient satisfaction [4][24] - The company anticipates some seasonal slowdown in demand during the holiday period but remains optimistic about long-term growth as awareness and confidence in EKTERLY build [52][72] Other Important Information - The company has recently hired key personnel, including a Chief Operating Officer and a Chief People Officer, to support its growth strategy [7] - The company is fully financed through profitability following a recent convertible note offering, allowing it to focus on executing the EKTERLY launch [7][23] Q&A Session Summary Question: Trends for types of patients switching to EKTERLY - Management noted that roughly half of the patients switching to EKTERLY report two or more attacks per month, indicating a high burden of disease [28][29] Question: Refill rates and access dynamics - Refill rates for high-burden patients are significantly higher than typical, with expectations for normalization as the patient population broadens [37][38] Question: Insurance negotiations and payer policies - The company is seeing favorable policies from regional and national payers and anticipates wrapping up discussions with larger payers early in 2026 [71] Question: Expected patient trialing EKTERLY - Management expects oral therapies to displace injectables over time, with a broad distribution of patients switching to EKTERLY, including those with lower disease burdens [59][60] Question: Inventory and shipment dynamics - The company is experiencing inventory builds as specialty pharmacies prepare for expected demand, indicating a disciplined approach to growth [69]