KalVista Pharmaceuticals (NasdaqGM:KALV) Q3 2025 Earnings Call November 11, 2025 08:30 AM ET Company ParticipantsBen Palleiko - CEONicole Sweeny - Chief Commercial OfficerBrian Piekos - CFOPaul Audia - CMORyan Baker - Head of Investor RelationsConference Call ParticipantsNone - AnalystNone - AnalystJoe Schwartz - AnalystStacy Ku - AnalystDebanjana Chatterjee - AnalystMaury Raycroft - AnalystNone - AnalystOperatorThank you for standing by. Welcome to KalVista Pharmaceuticals' 2025 third-quarter financial upd ...

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 [22] - Total operating expenses for the period were $59.7 million, consisting of approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses [23] - Gross to net came in toward the low end of the expected range this quarter, driven largely by lower copay utilization typical for this time of year [23] Business Line Data and Key Metrics Changes - EKTERLY's adoption in the U.S. has been steady and linear, with strong demand for treating HAE attacks [4] - The company has received 937 start forms, representing more than 10% of the HAE community, indicating strong early engagement [15] - The average number of cartons per shipment is on the high end of the expected range, aligning with utilization among high-burden patients [22] Market Data and Key Metrics Changes - The approval footprint for EKTERLY continues to grow, with recent approvals in Australia, Germany, and ongoing discussions for launches in the U.K. and Japan [5][20] - In Germany, the launch recorded first-day commercial sales, validating prescriber enthusiasm [19] - 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] - Plans to complete more agreements for expanding access in geographies where the company will not launch on its own [5] - The company is committed to demonstrating the real-world benefits of EKTERLY through ongoing data generation and patient education [6] Management's Comments on Operating Environment and Future Outlook - Management is encouraged by EKTERLY's early momentum and rapid growth, reinforcing the belief in its long-term success [24] - The company expects refill patterns to normalize as adoption expands beyond the highest burden patients [17] - Management acknowledges potential disruptions to demand during the holiday season but remains optimistic about the fundamentals of demand [51] Other Important Information - The company has recently hired key personnel to strengthen its capabilities, including a Chief Operating Officer and a Chief People Officer [7] - The recent convertible note offering has fully financed the company through profitability, allowing a focus on executing the EKTERLY launch [7] Q&A Session Summary Question: Trends for types of patients switching to EKTERLY - Approximately half of the patients who have switched to EKTERLY self-report an attack rate of two or more attacks per month, indicating a high burden [28] Question: Refill rates and access dynamics - Refill frequencies for high-burden patients are currently about once a month, significantly higher than the typical three to four months for other therapies [38] Question: Insurance negotiations and payer policies - The company anticipates wrapping up discussions with larger payers and PBMs to establish favorable policies for EKTERLY early in 2026 [71]

Financial Data and Key Metrics Changes - Sales of EKTERLY reached $13.7 million for the launch period through September 30, which includes $1.4 million recorded in July [21] - Total operating expenses for the period were $59.7 million, consisting of approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses [23] - Gross to net came in toward the low end of the expected range this quarter, driven largely by lower copay utilization typical for this time of year [23] Business Line Data and Key Metrics Changes - The U.S. launch of EKTERLY has seen strong adoption, with 937 start forms received, representing over 10% of the HAE community [15] - 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, indicating a growing reliance on EKTERLY [17] Market Data and Key Metrics Changes - The approval footprint for EKTERLY continues to grow, with recent approvals in Australia, Germany, and ongoing discussions for launches in the U.K. and Japan [5][19] - 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 scaling in the U.S. while expanding access globally [24] - The strategy includes evaluating optimal strategies to expand access in geographies where the company will not launch on its own, with more agreements anticipated [5] Management's Comments on Operating Environment and Future Outlook - Management is encouraged by the early momentum and rapid growth of EKTERLY, reinforcing the belief in its long-term success as market awareness continues to grow [24] - The company expects refill patterns to normalize as adoption expands beyond the highest burden patients [17] Other Important Information - The company has recently hired key personnel, including a Chief Operating Officer and a Chief People Officer, to support its growth [6] - The company is fully financed through profitability, allowing it to focus on executing the EKTERLY launch while evaluating additional growth opportunities [6] Q&A Session Summary Question: Trends for types of patients switching to EKTERLY - Management noted that roughly half of the patients who switched to EKTERLY self-report an attack rate of two or more attacks per month, indicating a high burden [27] Question: Proportion of paid versus free drug - The paid rate for EKTERLY continues to grow, with successful use of medical exceptions for access [31] Question: Refill rates for high-burden patients - Refill frequencies for high-burden patients are currently about once a month, significantly higher than the average for other therapies [38] Question: Insurance negotiations and payer policies - The company is seeing favorable policies being established by regional and national payers, with expectations to finalize discussions early in 2026 [73] Question: Revenue trajectory in the next couple of quarters - Initial fills are expected to continue, but refill rates may decline as the burden of disease on patients decreases [75]

Financial Data and Key Metrics Changes - Total revenues grew by 30% in Q3 2025 compared to the same quarter last year, reaching $97.3 million [2][19] - Operating profit increased to $15.8 million, nearly four times last year's result [2][19] - Operating cash flow was $32 million, restoring cash position to levels seen at the end of 2024 [2][19] - Gross profit grew by 33% to $90.2 million, resulting in a gross margin of 93% compared to 91% in the same quarter of 2024 [19][63] Business Line Data and Key Metrics Changes - Ruconest revenue increased by 29% year-on-year to $82 million, driven by new prescribers and patient enrollments [3][7] - Joenja's revenue grew by 35% year-on-year, generating $15.1 million, with a 25% increase in patients on treatment [3][11] - The company anticipates adding new growth sources for Joenja with pediatric indications and geographic expansion [3][12] Market Data and Key Metrics Changes - The company upgraded its full-year 2025 revenue guidance to $360-$365 million from the previous $335-$350 million [4][21] - The strong performance in Q3 reflects a solid foundation for growth, transitioning from a single-asset company to a biotech with two high-growth products [4][5] Company Strategy and Development Direction - The company aims to optimize capital deployment towards high-growth initiatives and enhance financial discipline [4][25] - Pharming is focused on building a leading global rare disease company, leveraging its strong capabilities in rare diseases [5][24] - The company is advancing its pipeline with two programs that have over $1 billion sales potential each [5][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth prospects of Ruconest, emphasizing its unique value for severe HAE patients [9][24] - The anticipated pediatric launch of Joenja is expected to be a significant growth driver, with preparations on track for a January 2026 approval [12][24] - Management highlighted the importance of maintaining financial discipline and ensuring efficient capital allocation [25][21] Other Important Information - The company is taking steps to reduce G&A headcounts to optimize capital deployment [4] - The recent publication in Cell suggests a higher prevalence of APDS, potentially expanding the patient population significantly [15][16] Q&A Session Summary Question: Impact of new oral therapy on Ruconest and revenue from pediatric patients on Joenja - Management does not see Ruconest competing with sebetralstat, as it serves a different patient population with more severe needs [28][29] - For Joenja, a significant number of pediatric patients identified are expected to convert to therapy quickly after approval [29] Question: Timeline for Ruconest withdrawal outside the US and competitive threats - The withdrawal is planned for the first half of next year, driven by financial sustainability concerns [36] - Management believes Ruconest serves a unique patient population and does not anticipate significant competitive threats [37] Question: Revenue guidance uplift and contributions from Ruconest and Joenja - The revenue guidance uplift is attributed to strong performances from both Ruconest and Joenja, with expectations for continued growth [54][55] Question: Capital allocation priorities and M&A plans - The company is focused on disciplined capital allocation and is not in a rush for M&A, looking for value-accretive opportunities [44][45] Question: Progress on the basket PID trial - The phase two proof-of-concept study is progressing well, with expected readouts in the second half of 2026 [46]

Investment Rating - The report indicates a positive investment outlook for the hereditary angioedema (HAE) treatment sector, particularly following the approval of the first oral on-demand treatment, sebetralstat [14][21]. Core Insights - The report highlights the urgent need for effective HAE treatments due to the high risk of life-threatening episodes, with nearly half of HAE patients facing potential asphyxiation [10][16]. - Sebetralstat, approved by the FDA, is noted for its rapid onset of action, achieving near-complete inhibition of plasma kallikrein within 15 minutes of administration [21]. - The KONFIDENT trial results demonstrate that sebetralstat significantly reduces symptom relief time compared to placebo, with median relief times of 1.61 hours for the 300 mg dose and 1.79 hours for the 600 mg dose [20][21]. Summary by Sections Section 1: HAE Overview - HAE is characterized by recurrent episodes of angioedema without urticaria, with a prevalence of approximately 1.5 per 100,000 individuals [7]. - The disease can lead to severe complications, including laryngeal edema, which has a mortality rate of up to 40% among patients [7][10]. Section 2: Current Treatment Landscape - Existing treatments include long-term preventive therapies (LTP) and on-demand treatments for acute episodes [10][11]. - The global HAE drug market reached $2.9 billion in 2022, with $2 billion attributed to long-term prevention and $900 million to acute on-demand treatments [13]. Section 3: Sebetralstat Approval and Efficacy - Sebetralstat is the first oral on-demand treatment for HAE, approved on July 7, 2025, and is expected to address unmet needs in the treatment landscape [21]. - The KONFIDENT trial, involving 136 patients across 20 countries, confirmed the efficacy and safety of sebetralstat, showing significant improvements in symptom relief and severity reduction compared to placebo [21]. Section 4: Future Developments - Pharvaris is developing deucrictibant, a competitive oral antagonist for HAE, with promising Phase II trial results indicating effective management of HAE attacks [26]. - The report anticipates further advancements in HAE treatments, with ongoing clinical trials expected to yield additional data in the coming years [26].

Group 1 - KalVista (NASDAQ: KALV) is nearing commercialization of its lead asset, sebetralstat, which targets the hereditary angioedema treatment market [1] - A significant FDA decision date is approaching, indicating potential regulatory approval for sebetralstat [1] - Successful de-risking events in the pediatric program and the development of strategic partnerships are underway, enhancing the company's growth prospects [1] Group 2 - The company operates in a sector that is expected to experience exponential expansion, aligning with high-growth investment strategies [1] - The focus on disruptive technologies and innovative enterprises is central to the company's investment approach [1]