KalVista Pharmaceuticals(US:KALV)2025-09-11 11:45Product Approval and Market Authorization - EKTERLY (sebetralstat) received FDA approval on July 3, 2025, becoming the first and only oral, on-demand therapy for hereditary angioedema (HAE) in patients aged 12 years and older[81] - The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK granted marketing authorization for EKTERLY in July 2025, providing up to 10 years of market exclusivity[83] - The European Medicines Agency (EMA) adopted a positive opinion for sebetralstat, with a final decision from the European Commission expected in October 2025[84] Financial Performance - Product revenue for the three months ended July 31, 2025, was $1.426 million, compared to zero for the same period in 2024, due to the commercial launch of EKTERLY[88] - Net cash used in operating activities was $54.5 million for the three months ended July 31, 2025, compared to $40.2 million for the same period in 2024, reflecting a significant increase in net loss adjustments[103] - The net loss for the three months ended July 31, 2025, was $60.0 million, adjusted for stock-based compensation and other factors, compared to a net loss of $40.4 million in the same period in 2024[103] Expenses - Research and development expenses decreased by $11.452 million to $15.162 million for the three months ended July 31, 2025, primarily due to reduced spending on EKTERLY and other R&D activities[90] - Selling, general and administrative expenses increased by $27.082 million to $44.683 million for the three months ended July 31, 2025, driven by higher personnel costs and commercial expenses[92] - Total operating expenses for the three months ended July 31, 2025, were significantly impacted by the increase in selling, general and administrative expenses, reflecting the company's focus on commercialization efforts[92] Cash Flow and Financing - Net cash provided by investing activities was $21.3 million for the three months ended July 31, 2025, down from $37.2 million in the prior year, primarily due to changes in marketable securities transactions[104] - Net cash provided by financing activities increased to $23.2 million in the three months ended July 31, 2025, compared to $3.0 million in the same period in 2024, driven by a milestone payment related to FDA approval[105] - The company reported a net decrease in cash, cash equivalents, and restricted cash of $7.3 million for the three months ended July 31, 2025, contrasting with a slight increase of $59,000 in the prior year[102] Contracts and Accounting - The company has ongoing contracts with research organizations and clinical trial sites, which are generally cancelable and not included in the contractual obligations table[106] - There have been no material changes to the company's critical accounting estimates in the three months ended July 31, 2025[107] - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[109] Licensing and Partnerships - KalVista Pharmaceuticals received a one-time payment of $22 million from DRI Healthcare following FDA approval, increasing the royalty rate on net sales up to $500 million from 5% to 6%[87] - The company entered into a License, Supply and Distribution Agreement with Kaken Pharmaceutical for exclusive commercialization rights in Japan, receiving an upfront payment of $11 million[100] Royalty Liabilities - The company experienced a significant increase in the royalty liability of $22.0 million related to the drawdown of the milestone payment after FDA approval of EKTERLY[105]