KalVista Pharmaceuticals (NasdaqGM:KALV) Q1 2026 Earnings Call September 11, 2025 08:30 AM ET Company ParticipantsRyan Baker - Head - IRBenjamin Palleiko - Director & CEONicole Sweeny - CCOBrian Piekos - CFOPaul Matteis - MD & Head - Therapeutics ResearchTazeen Ahmad - MD - US Equity ResearchPete Stavropoulos - Director - Biotech Equity ResearchDebanjana Chatterjee - Vice PresidentConference Call ParticipantsStacy Ku - Biotechnology Equity Research AnalystMaury Raycroft - Equity Research AnalystWill Soghiki ...

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 [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 ECTERLEET 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 - ECTERLEET is positioned as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks, with a positive community response and early uptake exceeding expectations [4][6] - Almost 5% of the entire U.S. HAE population has submitted a prescription for ECTERLEET since the launch [7] - The company activated 253 unique prescribers, with 38% starting multiple patients on ECTERLEET [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 ECTERLEET, 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 this year [8] Company Strategy and Development Direction - The company aims to redefine the standard of care for HAE with ECTERLEET, focusing on global expansion and commercial strategy execution [15] - Investments in commercial infrastructure prior to approval are yielding positive results in the launch of ECTERLEET [6] - The company is exploring partnerships worldwide to enhance market access for ECTERLEET [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong early response to ECTERLEET, highlighting the unmet need in HAE and the potential for the product to transform treatment [15] - The company anticipates that operating expenses will remain consistent as it continues to invest in the ECTERLEET launch [13] - Management noted that the rapid adoption of ECTERLEET reinforces its belief in the product's potential [15] 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 allows immediate access to ECTERLEET at no charge while pursuing medical exceptions for 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 ECTERLEET at no charge, with efforts to gain paid access through medical exceptions [19][20] 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 [23] Question: What are your expectations for launch metrics moving forward? - The company plans to share more detailed KPIs as the launch progresses, including repeat prescribers and utilization metrics [28] Question: Can you provide a breakdown of the 460 start forms? - All 460 start forms received were through the quick start program, 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] 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: How many patients are in the OLE and what is the expected timeline for transitioning to commercially reimbursed scripts? - The OLE includes several dozen U.S.-based patients, with a gradual transition expected as demand increases [56] Question: What has been the outcome of outreach efforts to raise awareness about ECTERLEET? - The company has engaged in local education programs and attended patient summits to raise awareness and facilitate adoption [58]

Financial Data and Key Metrics Changes - The company reported $1.4 million in net revenue for the launch period, primarily from stocking orders by specialty pharmacies [12] - 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, reflecting a quarter-over-quarter increase in SG&A driven by external spending related to the ECTERLEET launch [12][13] - The company had approximately $191 million in cash and investments as of July 31, 2025, which is expected to fund operations into 2027 [13][14] 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 initial launch metrics showing that nearly 5% of the entire U.S. HAE population has submitted a prescription [4][6] - The company has activated 253 unique prescribers, with 38% starting multiple patients on ECTERLEET, indicating strong early adoption [10] - The field sales team has reached over 72% of the total physician base, including 96% of tier one physicians [11] 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, and a staged launch anticipated over the next 12 to 18 months [6] - The UK MHRA granted marketing authorization for ECTERLEET, with a commercial launch expected in the first half of 2026 [7] - The company is progressing towards anticipated approval in Japan by the end of this year [7] Company Strategy and Development Direction - The company aims to redefine the standard of care for HAE with ECTERLEET, focusing on executing its commercial strategy with discipline and driving global expansion [15] - The management emphasizes the importance of early treatment and adherence to treatment guidelines to achieve total disease control for HAE patients [5] - The company is also exploring partnerships for regulatory filings in Canada and discussions with potential partners worldwide [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong response to ECTERLEET, highlighting the rapid adoption and engagement from patients and physicians [15] - The company anticipates that operating expenses will remain consistent as it continues to invest in the ECTERLEET launch [12] - Management noted that the early demand for ECTERLEET has exceeded expectations, indicating a broad interest across various patient demographics [42] Other Important Information - The company is transitioning its fiscal year end to December 31, with the next reporting period capturing the three-month period from July through September [14] - The management team includes key executives such as the CEO, CCO, and CFO, who are actively involved in the call [2][3] 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 [19][20] 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 [23] Question: What are the expectations for launch metrics moving forward? - The company plans to share more detailed KPIs as the launch progresses, including actual doses prescribed [25][27] 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 to patients [33] Question: Any feedback on side effects observed so far? - Adverse event reports have been minimal, with no significant GI-related adverse events reported [36][38] Question: What is the expected cadence for shifting patients from OLE to commercially reimbursed scripts? - The transition from OLE to commercial scripts is gradual, with no dramatic immediate shifts expected [56] Question: What are the expectations for formulary coverage? - The company anticipates parity access to branded therapies, with ongoing efforts to secure coverage [66]