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KalVista Pharmaceuticals (KALV) investor relations material
KalVista Pharmaceuticals Transition period summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
- EKTERLY's oral HAE therapy drives rapid adoption and global expansion, reshaping the market.KALV
Corporate presentation25 Mar 2026 - Oral on-demand HAE therapy adoption accelerates, boosting treatment rates and market growth.KALV
The Citizens Life Sciences Conference 202611 Mar 2026 - Ekterly's rapid adoption and high satisfaction are fueling strong refill-driven revenue growth.KALV
TD Cowen 46th Annual Health Care Conference4 Mar 2026 - Sebetralstat's rapid, broad efficacy and global launch plans aim to transform HAE treatment.KALV
2024 Cantor Fitzgerald Global Healthcare Conference20 Jan 2026 - Sebetralstat targets a $900M+ HAE market with a June 2025 US launch and global expansion planned.KALV
Stifel 2024 Healthcare Conference13 Jan 2026 - Oral HAE therapy sebetralstat nears approval, poised to transform on-demand treatment.KALV
Jefferies London Healthcare Conference 202413 Jan 2026 - EKTERLY's oral HAE therapy drives rapid growth, global expansion, and a robust rare disease pipeline.KALV
Corporate Presentation9 Jan 2026 - EKTERLY's rapid, global launch is driven by robust data, early treatment, and strong market demand.KALV
Cantor Global Healthcare Conference 20255 Jan 2026 - Oral HAE therapy sebetralstat nears approval, with strong data and high launch expectations.KALV
TD Cowen 45th Annual Healthcare Conference26 Dec 2025
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