KalVista Pharmaceuticals (KALV) Q3 2026 earnings summary

Executive summary

• EKTERLY, the first oral on-demand therapy for hereditary angioedema (HAE), launched in the U.S. and Germany, showing strong early adoption, high demand, and $13.7M in Q3 net product revenue, with 937 start forms and 423 unique prescribers in the U.S.

• Regulatory approvals span the U.S., EU, Switzerland, U.K., and Australia, with launches in Germany and further expansion planned in Japan and Singapore.

• Clinical data from KONFIDENT-KID and KONFIDENT-S trials highlight EKTERLY's efficacy, safety, and high patient satisfaction, supporting its foundational role in HAE treatment.

• Early commercial momentum is reflected in rapid uptake, high prescriber engagement, and strong refill rates among high-burden patients.

• The company operates as a single business segment focused on rare disease therapies.

Financial highlights

• Q3 2025 net product revenue reached $13.7M, with cost of revenue at $1.2M and gross margin of approximately 91%.

• Net loss for Q3 2025 was $49.5M, or $0.92 per share, compared to $39.1M, or $0.84 per share, in Q3 2024.

• Total operating expenses were $59.7M, with $12M in R&D and $46.5M in SG&A.

• Cash, cash equivalents, and marketable securities totaled $309.2M as of September 30, 2025.

• Gross-to-net was at the low end of expectations, mainly due to lower copay utilization.

Outlook and guidance

• Cash position and projected EKTERLY revenues are expected to fund operations through profitability, supported by recent convertible note offerings.

• SG&A expenses are expected to remain consistent as investment in EKTERLY's global launch continues.

• Formal payer access in the U.S. is expected in early 2026, with ongoing expansion in Europe and Japan.

• Management anticipates continued operating losses as global commercialization and development for pediatric and additional indications continue.

• Ongoing global regulatory submissions and pediatric studies aim to expand EKTERLY's market and indications.