KalVista Pharmaceuticals(KALV) - 2026 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported $1.4 million in net revenue for EKTERLY during the launch period, primarily from stocking orders by specialty pharmacies [13] - Total operating expenses for the period were $60.4 million, with approximately $15 million in R&D expenses and $45 million in SG&A expenses, driven by external spending related to the EKTERLY launch [13] - The company had approximately $191 million in cash and investments as of July 31, 2025, expected to fund operations into 2027 [14] Business Line Data and Key Metrics Changes - EKTERLY is positioned as the first and only oral on-demand therapy for acute HAE attacks, with initial launch metrics showing that nearly 5% of the U.S. HAE population has submitted a prescription [4][7] - The company has activated 253 unique prescribers, with 38% starting multiple patients on EKTERLY [11] - Early demand has come from patients previously on other therapies, with strong interest from a broad base of providers [11][12] Market Data and Key Metrics Changes - In Europe, sebetralstat received a positive CHMP opinion for the treatment of acute HAE attacks, with a final decision expected in October [7] - The UK MHRA granted marketing authorization for EKTERLY, with a commercial launch anticipated in the first half of 2026 [8] - The company is progressing towards anticipated approval in Japan by the end of the year [8] Company Strategy and Development Direction - The company aims to transform the treatment paradigm for HAE with EKTERLY, focusing on global expansion and establishing it as the foundational therapy for HAE [4][15] - The management emphasizes the importance of executing a disciplined commercial strategy and driving meaningful long-term value creation for shareholders [8][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong early response to EKTERLY, highlighting the unmet need in HAE and the transformational potential of the therapy [15] - The company anticipates that operating expenses will remain consistent as they continue to invest in the EKTERLY launch [13] Other Important Information - The company is changing its fiscal year end to December 31, starting with the quarter ending September 30, 2025 [14] - The quick start program provides immediate access to EKTERLY at no charge while working with physician offices to gain paid access [19][29] Q&A Session Summary Question: Can you further speak to the quick start program and expectations for timing to paid drug? - The quick start program provides immediate access to EKTERLY at no charge, with efforts to gain paid access through medical exceptions [19][20] Question: How many of the 4,000 patients in the database are individual patients or caregivers? - The majority of patients in the database are individual patients, with efforts to engage them through local education programs [23] Question: What are your expectations for launch metrics moving forward? - The company plans to share more KPIs as the launch progresses, including repeat prescribers and utilization rates [28] Question: Can you provide a breakdown of the 460 start forms? - All 460 start forms received quick start access, with some paid shipments already going out [34] Question: What feedback have you received regarding side effects observed so far? - Adverse events reported have been minimal, with no significant GI-related issues noted during the launch [37][38]