KalVista 制药公司 SEC 10-Q 报告

KalVista Pharmaceuticals, Inc. has released its Form 10-Q report for Q3 2025, highlighting a product revenue of $1.4 million from the launch of EKTERLY, its new therapy for hereditary angioedema. The company reported an operating loss of $59 million and a net loss of $60.1 million. EKTERLY received FDA approval and is the first oral therapy for HAE. The company is expanding its market presence with regulatory submissions in various regions and anticipates continued losses as it commercializes EKTERLY and develops new products.

KalVista Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of therapies for rare diseases, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and key business activities, including the commercial launch of its new product EKTERLY.

Financial Highlights

Product revenue, net: $1.4 million, reflecting the commercial launch of EKTERLY in the United States following FDA approval.
Operating loss: $(59.0) million, driven by increased selling, general and administrative expenses related to the commercialization of EKTERLY.
Net loss: $(60.1) million, impacted by operating expenses and interest expenses related to the royalty obligation.
Net loss per share, basic and diluted: $(1.12), reflecting the net loss and weighted average common shares outstanding.

Business Highlights

New Product Launch: EKTERLY (sebetralstat), a novel, orally delivered small molecule plasma kallikrein inhibitor, was launched for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. This marks the first and only oral, on-demand therapy for HAE, approved by the FDA on July 3, 2025.
Regulatory Approvals: EKTERLY received marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The European Commission's final decision is expected in October 2025.
Geographical Performance: The company has expanded its market presence with regulatory submissions for EKTERLY under review in the EU, Japan, Switzerland, and other territories. Additionally, exclusive rights for regulatory approval and commercialization in Canada were granted to Pendopharm.
Sales Units: The company reported its first period of product sales for EKTERLY, generating $1.4 million in net product revenue for the three months ended July 31, 2025.
Operational Expansion: The company maintains a global presence with offices and research activities in multiple locations, including Framingham, Massachusetts; Cambridge, Massachusetts; Porton Down, UK; Salt Lake City, Utah; Zug, Switzerland; Tokyo, Japan; Berlin, Germany; and Dublin, Ireland.
Future Outlook: The company anticipates continued losses as it commercializes EKTERLY and develops additional product candidates. It plans to finance future cash needs through equity offerings, debt financing, corporate partnerships, and product sales.
Segment Information: The company operates as a single business segment, focusing on the development and commercialization of therapies for rare diseases, with the Chief Executive Officer as the chief operating decision-maker.

SEC Filing: KalVista Pharmaceuticals, Inc. [ KALV ] - 10-Q - Sep. 11, 2025