KalVista Pharmaceuticals(KALV) - 2026 Q2 - Quarterly Report

FDA Approval and Product Launch - EKTERLY (sebetralstat) received FDA approval on July 3, 2025, as the first and only oral, on-demand therapy for hereditary angioedema (HAE) in patients aged 12 years and older[89]. - The company generated revenue from product sales for the first time in the three months ended September 30, 2025, following FDA approval of EKTERLY on July 3, 2025[104]. - EKTERLY is under review with regulatory authorities in Japan and Singapore, indicating potential future market expansion[87]. Financial Performance - Product revenue for the three months ended September 30, 2025, was $13.7 million, a 100% increase compared to the same period in 2024, attributed to the commercial launch of EKTERLY in the U.S.[96]. - The operating loss for the three months ended September 30, 2025, was $46.1 million, a 6% increase from the prior year[96]. - The total operating expenses for the nine months ended September 30, 2025, were $168.4 million, a 26% increase compared to the same period in 2024[97]. - Other (expense) income decreased by $5.7 million for the three months ended September 30, 2025, primarily due to an increase in interest expense and unfavorable changes in foreign currency exchange rates[103]. Expenses and Cash Flow - Research and development expenses decreased by $6.7 million (36%) for the three months ended September 30, 2025, primarily due to reduced spending on sebetralstat[99]. - Selling, general and administrative expenses increased by $21.7 million (88%) for the three months ended September 30, 2025, driven by higher personnel costs and commercial expenses[102]. - Cash used in operating activities was $127.0 million for the nine months ended September 30, 2025, compared to $91.7 million for the same period in 2024, representing a 39% increase[114]. - Cash provided by financing activities was $164.4 million for the nine months ended September 30, 2025, primarily from the sale of convertible notes of $139.4 million[116]. - Cash provided by investing activities was $19.9 million for the nine months ended September 30, 2025, compared to cash used of $55.7 million in the same period in 2024, a change of 136%[115]. Strategic Agreements and Payments - The company received a one-time payment of $22 million from DRI Healthcare following FDA approval, increasing the royalty rate on initial sales from 5% to 6%[94]. - The company received an upfront payment of $100.0 million from a royalty purchase agreement with DRI, along with a one-time cash payment of $22.0 million after obtaining FDA approval of sebetralstat[109]. - The company entered into a License, Supply and Distribution Agreement with Kaken Pharmaceutical Co., Ltd., receiving an upfront payment of $11.0 million and potential milestone payments totaling approximately $13.0 million[110]. Cash Position - As of September 30, 2025, the company had an increase in cash, cash equivalents, and restricted cash of $61.3 million, a significant increase of 799% compared to the prior year[113]. - The company filed a registration statement with the SEC to offer and sell securities with an aggregate public offering price of up to $300 million[106].