KalVista Pharmaceuticals (KALV) Transition period summary

Executive summary

• EKTERLY, the first oral on-demand treatment for hereditary angioedema (HAE), launched in the U.S. in July 2025, generating $49.1 million in global net product revenue during the eight months ended December 31, 2025, with rapid adoption and strong patient and physician engagement.

• 1,702 patient start forms received in the U.S. since launch, representing nearly 20% of the U.S. HAE population and 724 unique prescribers as of February 2026.

• EKTERLY launched in Germany and Japan, with global expansion plans and partnerships in Latin America to broaden access.

• EKTERLY is now recommended as a first-line therapy for adolescents in international guidelines, reflecting robust clinical data and high satisfaction.

• Completed enrollment in the Phase 3 KONFIDENT-KID trial for pediatric HAE patients a year ahead of schedule.

Financial highlights

• Net product revenue for the eight-month period ended December 31, 2025, was $49.1 million, with $35.4 million generated in Q4, aided by specialty pharmacy inventory build-up.

• Total operating expenses were $160.2 million, up from $117 million in the prior year period, reflecting commercial launch investments.

• Operating loss was $112 million, slightly improved from $117 million in the prior year period; net loss was $109.5 million.

• Cost of revenue was $3.1 million, with most inventory sold in 2025 previously expensed to R&D.

• R&D expenses decreased to $33.4 million due to lower clinical trial costs and reclassification of expenses.

Outlook and guidance

• Cash, cash equivalents, and marketable securities of $300.2 million at year-end 2025 are expected to fund operations through profitability.

• Operating expenses are expected to remain consistent on a 12-month basis, except for a meaningful increase in cost of revenue as zero-cost inventory is depleted.

• No formal revenue guidance provided due to early stage of launch, but management expects continued linear growth in patient demand and commercial metrics.

• NDA submission for pediatric use (ages 2–11) planned for Q3 2026, targeting a potential U.S. launch in 2027.

• Additional international market expansions are planned for 2026.