KalVista Pharmaceuticals (KALV) Q1 2026 earnings summary

Executive summary

• EKTERLY (sebetralstat) received FDA approval in early July 2025 as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks in patients aged 12 and older, with immediate U.S. launch and strong initial uptake.

• Nearly 5% of the U.S. HAE population submitted prescriptions within weeks of launch, with 460 patient start forms and 253 unique prescribers in the first eight weeks.

• Regulatory progress includes positive CHMP opinion in Europe, UK MHRA approval, and anticipated launches in Europe, UK, Japan, and Canada over the next 12–18 months.

• License agreement signed with Kaken Pharmaceutical for Japanese commercialization, with $11 million upfront payment received.

• Orphan drug status in the EU and UK provides up to 10 years of market exclusivity.

Financial highlights

• First sales of EKTERLY generated $1.4 million in net revenue for the launch period, primarily from specialty pharmacy stocking orders.

• Net loss for the quarter was $60.1 million, or $1.12 per share, compared to $40.4 million, or $0.87 per share, in the prior year.

• Research and development expenses decreased to $15.2 million from $26.6 million year-over-year.

• Selling, general and administrative expenses rose to $44.7 million from $17.6 million year-over-year, reflecting commercialization costs.

• Cash, cash equivalents, and marketable securities totaled $191.5 million as of July 31, 2025, expected to fund operations into 2027.

Outlook and guidance

• Operating expenses are expected to remain consistent through the remainder of 2025 as investments in EKTERLY's launch continue.

• EMA decision on EU approval for sebetralstat anticipated in early October 2025, with staged launches in Europe, UK (H1 2026), and Japan (early 2026).

• Fiscal year end is changing to December 31, with future reporting on a calendar quarter basis.

• Ongoing studies for EKTERLY in children aged 2–11 and regulatory applications under review in key global markets.

• Management anticipates continued operating losses as commercialization ramps up and post-approval obligations are met.