KalVista Pharmaceuticals, Inc. Q1 FY2026 earnings call

Ben Palleiko's Highlights

• FDA approved EKTERLY as the first oral on-demand therapy for acute HAE attacks in adults and pediatric patients 12 and older. Initiated U.S. launch immediately, with early uptake greater than expected.
• Regulatory progress: Europe's CHMP gave positive opinion for sebetralstat, U.K. MHRA granted marketing authorization, Japan approval expected end 2025, and Canadian partnership progressing.

Nicole Sweeny's Highlights

• Strong patient interest with over 4,000 individuals joining the patient database within weeks of approval. Received 460 patient start forms in 8 weeks ending August 29.
• Field sales focused on engaging top 1,000 HAE treating physicians, with 253 unique prescribers activated and 38% starting multiple patients.
• KalVista Care hub services operational to help patients navigate access and financial support.

Brian Piekos' Highlights

• Financials: $60.4 million in operating expenses, $15M in R&D and $45M in SG&A. Cash and investments of $191M as of July 31, 2025. Expect operating expenses to remain consistent for EKTERLY launch.

The company reported net revenue of $1.4 million for the launch period of EKTERLY, the first and only oral on-demand therapy for acute HAE attacks. This revenue primarily came from stocking orders by specialty pharmacies and the commercial distribution network. There are no other product segments detailed in this quarter as EKTERLY is the main focus.

Forward-looking Statements

• Anticipate U.K. commercial launch of EKTERLY in the first half of 2026.
• Staged launch in Europe over 12-18 months starting with Germany.
• Japan approval expected end 2025 with launch in early 2026 via Kaken Pharmaceutical.
• Cash and investments expected to fund operations into 2027.

Risks Discussed

• Regulatory approval processes taking longer than expected for global launches.
• Challenges with insurance coverage and prior authorizations for patient access.
• Market adoption variability, though early signs are positive but uncertainty remains.

Q: Can you further speak to the Quickstart program and the process of prior authorizations and medical exemptions?

A: The Quickstart program provides immediate access to EKTERLY at no charge. Patients submit start forms, and KalVista works with physician offices to pursue medical exceptions for paid access.

Q: What are your expectations for timing to get paid drug and how to translate patient start forms to paid drug?

A: Formal coverage policies typically take up to 6 months, but Quickstart and medical exception processes are proceeding as planned.

Q: Are you able to confirm the insurance process where patients first receive 2 doses initially and then paid drug if insurance is approved?

A: Patients typically receive 2 boxes initially. Refills are dependent on physician prescription, usually PRN for flexibility based on disease burden.

Q: Any feedback on side effects observed thus far?

A: Overall, adverse event reports have been minimal, with no significant GI discomfort or laryngeal attacks reported.

Q: Can you provide a July versus August breakdown of the 460 start forms?

A: The 460 start forms include those with Quickstart, and paid shipments are starting to go out as medical exception processes are completed.

Q: How should we think about stockpiling as a dynamic in revenue going forward?

A: Similar to other rare disease launches, specialty pharmacies are expected to hold 2 to 4 weeks of inventory long-term, with early launch inventory potentially fluctuating.