KalVista Pharmaceuticals (KALV) investor relations material

Market overview and competitive landscape

• Hereditary angioedema (HAE) affects about 9,000 people in the U.S., with prevalence estimates ranging from 1 in 35,000 to 1 in 50,000.

• The U.S. HAE market is split between prophylaxis (70% of patients) and on-demand therapy, with nearly all patients requiring on-demand treatment due to breakthrough attacks.

• On-demand therapies have seen little innovation until recently, with most options being injectables or IVs, leading to under-treatment of attacks.

• The market for acute HAE therapies has remained stable at around 84,000 doses annually, translating to under $700 million in sales, but could reach $1.3–$1.4 billion if all doses were branded.

• Oral therapies are expected to displace injectables over time, increasing both market share and the number of attacks treated.

Product innovation and clinical impact

• EKTERLY is the first oral on-demand therapy for HAE, offering injectable-like efficacy with a strong safety profile.

• Clinical data show patients treat attacks much earlier with EKTERLY (average 9 minutes) compared to injectables (3.8 hours), especially benefiting adolescents.

• Open label extension studies indicate patients treat a higher proportion of attacks (85%+) with EKTERLY, compared to 50–60% historically.

• Early treatment significantly improves attack outcomes, as shown in recent clinical posters.

• The therapy is broadening access, with both high and low disease burden patients adopting it.

Commercial performance and growth metrics

• EKTERLY's launch has seen continuous, linear growth, with start forms and refill rates exceeding initial expectations.

• Refills now represent the majority of revenue, and refill frequency is higher than anticipated, with patients refilling every two months on average.

• Initial uptake was strongest among high disease burden patients (2+ attacks/month), but adoption is expanding across the broader patient population.

• Most new users are also on prophylaxis, mirroring current market trends, and are switching from leading on-demand injectables.

• Sales reached $35 million in Q4, with growth expected to continue, though no formal guidance was provided.