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KalVista Pharmaceuticals (KALV) investor relations material
KalVista Pharmaceuticals Q1 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q1 2026 earnings summary11 Sep, 2025
Executive summary
FDA approved EKTERLY/ECTERLEET 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 in July 2025 and strong initial uptake.
Early adoption exceeded expectations, with 460 patient start forms in the first eight weeks, representing nearly 5% of the U.S. HAE population, and broad engagement from patients, physicians, and payers.
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.
$22 million milestone payment received from DRI Healthcare following FDA approval, increasing royalty rate and milestone potential.
Financial highlights
First sales generated $1.4 million in net product revenue for the quarter ended July 31, 2025, primarily from U.S. specialty pharmacy 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 $45 million, up 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 as investments in the EKTERLY/ECTERLEET launch continue.
Cash position of $191 million as of July 31, 2025, expected to provide operational runway into 2027.
EMA decision on EU approval for sebetralstat anticipated in early October 2025, with ongoing regulatory reviews in Japan, Switzerland, and other territories.
Transitioning to a calendar fiscal year, with next report covering July–September 2025.
Ongoing studies for EKTERLY in children aged 2–11 and regulatory applications under review in key global markets.
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Cantor Crypto & AI Infrastructure Conference10 Nov, 2025
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Frequently asked questions
KalVista Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development, and commercialization of small molecule protease inhibitors, which are primarily aimed at treating diseases with significant unmet medical needs. The company focuses on advancing a portfolio of inhibitors targeting the kallikrein-kinin system, a key pathway in the human body related to swelling and inflammation. KalVista's research has produced sebetralstat, an oral treatment for hereditary angioedema (HAE), a rare and potentially life-threatening genetic condition characterized by spontaneous episodes of swelling. Additionally, the company is exploring oral Factor XIIa inhibitors, which are in preclinical development stages, for the prophylactic treatment of HAE, along with potential therapies for thrombosis and inflammation. The company is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.
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