KalVista Pharmaceuticals, Inc. Q1 FY2025 earnings call

• Ben Palleiko noted 2025 was pivotal with EKTERLY's successful multinational launch, $35M in Q4 global net product revenue, U.S. launch metrics like 1,702 patient start forms and 724 unique prescribers, Germany launch strong start, Japan and Latin America progress. Focus on pediatric opportunity with NDA submission in 2026 Q3 for children 2 - 11.
• Paul Audhya discussed new sebetralstat clinical data from meetings, longitudinal data showing consistent performance, high patient satisfaction, preference over injectables in studies, and international pediatric guideline recommending EKTERLY as first-line for adolescents 12 +.
• Nicole Sweeny talked about U.S. launch progress with 384 new start forms in Jan - Feb 2026, over 1,700 start forms total, 724 unique prescribers, refills being majority of units and revenue, impact of winter weather on start forms, and market research showing top drivers of EKTERLY use as oral administration and early attack treatment.

For the 8 months ended December 31, 2025, global net product revenue was $49.1 million, with $35.4 million in the fourth quarter. Cost of revenue was $3.1 million. Research and development expenses were $33.4 million, SG&A expenses were $124.7 million. Operating loss was $112 million. EKTERLY's launch in the U.S. had 1,702 patient start forms and 724 unique prescribers as of February 28. Germany launch has strong early adoption, Japan launch activities initiated, and Latin America partnership for sebetralstat.

Operating expenses expected to remain relatively consistent when adjusted for 12 - month period except cost of revenue will increase as sell through remaining zero - cost inventory. Company doesn't provide guidance currently as it's early in launch and prefer to convey consistent trends. Anticipate launch to be consistent and linear with quarter - to - quarter fluctuations not indicating fundamental change.

Q: Tazeen Ahmad asked about ex - U.S. launches nuancing and peak sales split.

A: Ben Palleiko said German trends track U.S., Japan launch too early to extrapolate. Peak sales split likely U.S. 85% plus or minus.

Q: Paul Matteis asked about patient types started and linear growth in start forms.

A: Nicole Sweeny said seeing growth in high - burden, mild, and moderate disease patients. Brian Piekos said small impact to Q1 gross - to - net from co - pay assistance.

Q: Stacy Ku asked about refill trends, high - burden patient penetration, and start form adds.

A: Nicole Sweeny said refills 1 - 3 cartons per refill, high - burden patients refill more frequently, share of high - burden patients growing. Ben Palleiko said seasonality like weather and deductible resets impact start forms but launch expected linear.

Q: Amy on for Maury Raycroft asked about refill rates and sales shaping.

A: Benjamin Palleiko said no guidance yet, consistent trends. Nicole Sweeny said refills 1 - 3 cartons per refill, high - burden patients more frequent.

Q: Will on for Joe Schwartz asked about U.S. market penetration and on - demand market growth.

A: Benjamin Palleiko said market should transition to oral therapies, treatment rates should go higher, $1.5B TAM achievable by converting to orals.

Q: Serge Belanger asked about payer reimbursement and short - term prophylaxis.

A: Nicole Sweeny said leveraging mix of medical exception and policies, focusing on remaining PBMs. Paul Audhya said ongoing studies on short - term prophylaxis, data encouraging.

Q: Catherine on for Jon Wolleben asked about impact on generic icatibant prescriptions.

A: Benjamin Palleiko said still early in launch, not seeing tremendous impact yet but will become more apparent through the year