First Oral HAE Treatment Surpasses $50 Million in Sales, U.S. Biotech Shows Profit Confidence

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) announced that, after shifting its fiscal year-end from April 30 to December 31, it reported financial results for the eight-month transition period in 2025. Revenue from EKTERLY, its oral on-demand therapy for acute attacks of hereditary angioedema (HAE), reached approximately $49.1 million (about KRW 660 billion). In the U.S., the company has secured over 1,700 patient-start forms and more than 700 prescribing physicians. Initial sales have also begun in Germany and Japan, where EKTERLY has been listed on the national health insurance system through partner Kaken Pharmaceutical.

Bolstered by cash and short-term investments totaling roughly $302 million (about KRW 400 billion), KalVista expects to fund both continued EKTERLY revenue growth and a path to profitability. The company has completed early enrollment in the Phase 3 KONFIDENT-KID trial—targeting children aged 2–11—and plans to submit a U.S. pediatric indication application in the third quarter of 2026, with a projected launch in 2027.

Earlier in 2025, EKTERLY became the first oral on-demand treatment for HAE acute attacks to gain approvals in the U.S., the European Union, the U.K., and Switzerland. European launches are underway on a country-by-country basis, beginning with Germany in the fourth quarter of 2025. In December 2025, Japanese regulatory authorities approved EKTERLY for patients aged 12 and older, and following its inclusion in Japan’s national health insurance, commercial sales have commenced via Kaken Pharmaceutical—further extending KalVista’s global revenue base.

KalVista, a U.S. biotech focused on therapies for the rare disease hereditary angioedema, is advancing global commercialization of EKTERLY through pediatric indication expansion and regional partnerships. Until now, on-demand HAE treatment relied on intravenous or subcutaneous injectables; with EKTERLY’s approval as the first oral on-demand option, the market is entering a new phase of competition centered on treatment convenience and accessibility.