KalVista Pharmaceuticals (KALV) 24th Annual Needham Virtual Healthcare Conference summary

Regulatory and clinical update

• Sebetralstat is approaching a June 17 PDUFA date, with FDA review nearly complete and no outstanding issues or expected advisory committee.

• Six additional global filings are underway, with a German launch planned for later this year and further launches in 2026.

• The anticipated label is expected to be clean, reflecting robust efficacy and safety data, with possible max daily dosing similar to existing therapies.

• Clinical data show strong efficacy across all attack types, including laryngeal attacks, and a benign safety profile.

• An orally disintegrating tablet (ODT) formulation is in development for pediatric use and as an alternative for adults, with pediatric sNDA filing expected in the first half of next year.

Commercial launch and market preparation

• U.S. commercial launch is anticipated in July, with a field team of 32 reps already onboarded and engaging with key physicians.

• Market access, patient support, and supply chain teams are fully operational, with a mock launch completed to identify and address potential challenges.

• Pricing will be set within the $11,000–$16,000 per dose range, aligning with branded competitors and not with generics.

• Commercial payers represent about 70% of the market, with commercial coverage expected to come first.

• Ex-U.S. launches will be a mix of direct and partnership models, with Germany and the U.K. prioritized and potential partnerships in Japan and other regions.

Market opportunity and competitive landscape

• The on-demand HAE market is stable at around 85,000 doses per year, with most demand from Firazyr and generic icatibant users.

• Sebetralstat is expected to see strong initial demand, with both patient and physician support due to its oral, shelf-stable form and favorable safety profile.

• The product enables higher treatment rates for HAE attacks, addressing unmet needs due to the burdens of injectable therapies.

• Ex-U.S. markets are heavily weighted toward on-demand therapy, with lower rates of modern prophylaxis, supporting global opportunity.

• The U.S. is expected to account for about 80% of steady-state sales, with the remainder from international markets.