$49.1 million global net product revenue of EKTERLY® (sebetralstat) for the eight months ended December 31, 2025
1,702 patient start forms received in the US from launch through end of February, reflecting continued rapid adoption of first and only oral on-demand treatment for hereditary angioedema (HAE)
EKTERLY launched in Japan by partner Kaken Pharmaceutical Co., LTD
Company to host conference call today at 8:30am ET
FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today reported financial results for the eight months ended December 31, 2025, and provided a corporate update. As previously announced, the Company changed its fiscal year from ending April 30 of each year to ending December 31 of each year. There was an eight-month transition period from May 1, 2025 to December 31, 2025 and these results are presented within the condensed consolidated financial statements.
“As we enter the next phase of the EKTERLY launch, we are seeing the benefits of disciplined execution and increasing real-world experience with the first and only oral on-demand therapy for HAE,” said Ben Palleiko, CEO of KalVista. “The trend towards high adoption continues, as evidenced by steady underlying demand and increasing utilization from patients seeking the benefits of an oral on-demand option. Internationally, EKTERLY’s early performance in Germany, the recent launch in Japan by our partner Kaken Pharmaceutical and our plans to initiate additional market expansions in 2026, reinforce our confidence in the appeal across global markets. We remain focused on expanding access to EKTERLY worldwide while advancing our pediatric filing in patients aged 2–11 later this year. Together, we believe these efforts position EKTERLY to become the foundational therapy for people living with HAE.”
EKTERLY® (sebetralstat) Commercial Progress
Clinical and Regulatory Progress
Transition Period Financial Results
Earnings Conference Call and Webcast KalVista management will host a conference call and webcast to discuss the results at 8:30 a.m. ET on Wednesday, March 25, 2026. The live audio webcast will be accessible on the Investors section of the Company’s website at https://ir.kalvista.com/event-calendar. An archived replay will be available on the site approximately two hours after completion of the event.
About EKTERLY® (sebetralstat) EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With a US regulatory filing planned for 2026 to expand use to children aged 2–11, and additional filings anticipated in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information, including the full US Prescribing Information, visit EKTERLY.com.
About KalVista Pharmaceuticals, Inc. KalVista is a global pharmaceutical company dedicated to delivering life-changing therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.
Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "position," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, our financial projections and anticipated cash runway, the success of our efforts to commercialize EKTERLY®, including revenues from sales of EKTERLY, our ability to successfully obtain additional foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE, the timing of regulatory filings and product launches, our plans for international expansion, expectations regarding market adoption and utilization trends, and our ability to establish and maintain strategic partnerships. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our transition report on Form 10-KT for the transition period from May 1, 2025 to December 31, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
KALVISTA PHARMACEUTICALS, INC. Consolidated Balance Sheets (in thousands except share and per share amounts) (Unaudited) |
||||||||
|
|
December 31, |
|
|
April 30, |
|
||
|
|
2025 |
|
|
2025 |
|
||
Cash, cash equivalents & Marketable securities |
|
$ |
300,214 |
|
|
$ |
220,617 |
|
Other current assets |
|
|
19,933 |
|
|
|
21,073 |
|
Total current assets |
|
|
320,147 |
|
|
|
241,690 |
|
Other assets |
|
|
15,228 |
|
|
|
9,080 |
|
Total assets |
|
$ |
335,375 |
|
|
$ |
250,770 |
|
|
|
|
|
|
|
|
||
Current liabilities |
|
$ |
57,355 |
|
|
$ |
45,167 |
|
Long-term liabilities |
|
|
280,731 |
|
|
|
110,212 |
|
Total Liabilities |
|
338,086 |
|
|
155,379 |
|
||
Stockholders’ (deficit) equity |
|
|
(2,711 |
) |
|
|
95,391 |
|
Total liabilities and stockholders’ (deficit) equity |
|
$ |
335,375 |
|
|
$ |
250,770 |
|
KALVISTA PHARMACEUTICALS, INC. Consolidated Statements of Operations (in thousands, except share and per share amounts) (Unaudited) |
||||||||
|
|
For the Eight Months Ended |
||||||
|
|
December 31, |
||||||
|
|
2025 |
|
|
2024 |
|
||
Product revenue, net |
|
$ |
49,078 |
|
|
$ |
— |
|
Cost of revenue |
|
|
3,081 |
|
|
|
— |
|
Research and development |
|
|
33,371 |
|
|
|
52,166 |
|
Selling, general and administrative |
|
|
124,663 |
|
|
|
64,864 |
|
Total operating expenses |
|
|
161,115 |
|
|
|
117,030 |
|
Operating loss |
|
|
(112,037 |
) |
|
|
(117,030 |
) |
Total other income |
|
|
1,480 |
|
|
|
6,576 |
|
Loss before income taxes |
|
|
(110,557 |
) |
|
|
(110,454 |
) |
Income tax (benefit) expense |
|
|
(1,033 |
) |
|
|
— |
|
Net loss |
|
$ |
(109,524 |
) |
|
$ |
(110,454 |
) |
Net loss per share, basic and diluted |
|
$ |
(2.03 |
) |
|
$ |
(2.30 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
53,870,007 |
|
|
|
47,958,970 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20260325488975/en/
Investors: Ryan Baker Head, Investor Relations (617) 771-5001 [email protected] Media: Molly Cameron Sr. Director, Corporate Communications (857) 356-0164 [email protected]
Source: KalVista Pharmaceuticals, Inc.