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

Financial Data and Key Metrics Changes - The company reported $1.4 million in net revenue for the launch period of ECTERLEET, primarily from stocking orders by specialty pharmacies [14] - 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 ECTERLEET launch [14] - The company had approximately $191 million in cash and investments as of July 31, 2025, expected to fund operations into 2027 [15] Business Line Data and Key Metrics Changes - ECTERLEET is positioned as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks, with a strong initial uptake, as nearly 5% of the U.S. HAE population submitted prescriptions shortly after launch [5][8] - The company has activated 253 unique prescribers, with 38% starting multiple patients on ECTERLEET [12] - Early demand has come from patients previously on other therapies, with a significant number of patients adopting ECTERLEET from various prophylactic therapies [11][13] 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 [8] - The UK MHRA granted marketing authorization for ECTERLEET, with a commercial launch anticipated in the first half of 2026 [9] - The company is progressing towards anticipated approval in Japan by the end of this year, with a launch planned for early 2026 [9] Company Strategy and Development Direction - The company aims to transform the treatment paradigm for HAE with ECTERLEET, focusing on global expansion and establishing it as the foundational therapy for HAE [5][16] - The management is committed to executing a disciplined commercial strategy while driving global expansion and delivering meaningful treatment to patients [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong community response to ECTERLEET, highlighting the unmet need it addresses [7] - The rapid adoption of ECTERLEET reinforces the belief that it can redefine the standard of care for HAE patients [16] Other Important Information - The company is changing its fiscal year end to December 31, starting with the quarter ending September 30, which will capture the three-month period from July through September [15] 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 ECTERLEET at no charge while pursuing medical exceptions for paid access [20][21] Question: How many of the 4,000 patients and caregivers signed up for ECTERLEET updates are individual patients? - The majority of the 4,000 individuals in the database are patients, with caregivers also included [24] Question: What are the expectations for launch metrics moving forward? - The company anticipates evolving KPIs, including actual doses prescribed as the launch progresses [29] Question: Can you provide a breakdown of the 460 start forms? - All 460 start forms received quick start access, and paid shipments have started going out [35] Question: What feedback has been received regarding side effects observed so far? - Adverse events reported have been minimal, with no significant GI-related issues noted during the launch [38][39] Question: Can you provide a July versus August breakdown of the start forms? - The demand has shown a sustained and continually growing level of interest, indicating a linear growth trajectory [42] Question: What is the expected cadence or timeline to shift patients to commercially reimbursed scripts? - The transition from OLE patients to commercial scripts is gradual, with no dramatic immediate shifts expected [58] Question: What has been the outcome of outreach and educational programs? - The company has engaged in local education programs and events to raise awareness about ECTERLEET, with positive outcomes noted [60]