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EKTERLY drives $49.1M revenue as KalVista (Nasdaq: KALV) reports net loss

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

KalVista Pharmaceuticals reported results for the eight-month transition period ended December 31, 2025, reflecting its shift to a calendar fiscal year. The company generated $49.1 million in global net product revenue from EKTERLY, the first and only oral on-demand treatment for hereditary angioedema.

Adoption is highlighted by 1,702 US patient start forms from launch through February and launches in markets including Germany and Japan through partner Kaken. Despite this growth, KalVista reported a net loss of $109.5 million and basic and diluted net loss per share of $2.03 for the period.

On the balance sheet, cash, cash equivalents and marketable securities were $300.2 million as of December 31, 2025, with total assets of $335.4 million and total liabilities of $338.1 million, resulting in a modest stockholders’ deficit. Management reiterated plans to expand EKTERLY access and advance pediatric filings.

Positive

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Insights

EKTERLY revenue ramps quickly, but losses and leverage remain high.

KalVista showed a strong commercial start for EKTERLY, with $49.1 million in product revenue over eight months and 1,702 US patient start forms, plus initial launches in Germany and Japan. This underlines meaningful early demand in hereditary angioedema.

Financially, the company is still in heavy investment mode. Selling, general and administrative expenses reached $124.7 million, supporting the global launch, while research and development was $33.4 million. Net loss was $109.5 million, only slightly improved versus the prior-year period.

The balance sheet shows $300.2 million in cash, cash equivalents and marketable securities as of December 31, 2025, but total liabilities of $338.1 million led to a stockholders’ deficit. Future filings will clarify how EKTERLY revenue growth interacts with operating costs and liabilities as additional markets come online.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 25, 2026

 

 

KALVISTA PHARMACEUTICALS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-36830   20-0915291
(State or Other Jurisdiction
of Incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

200 Crossing Boulevard  
Framingham, Massachusetts   01702
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: 857 999-0075

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange
on which registered

Common Stock, $0.001 par value per share   KALV   The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 2.02

Results of Operations and Financial Condition.

On March 25, 2026, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the eight month transition period ended December 31, 2025. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.

The information furnished with Item 2.02 of this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

Number

  

Exhibit Description

99.1    Press release dated March 25, 2026
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

      KALVISTA PHARMACEUTICALS, INC.
Date: March 25, 2026     By:  

/s/ Brian Piekos

     

Brian Piekos

Chief Financial Officer

Exhibit 99.1

KalVista Pharmaceuticals Reports Eight Months Fiscal Year 2025 Financial Results and Provides Corporate Update

$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, March 25, 2026 – 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

 

   

Initiated the US commercial launch of EKTERLY on July 7, 2025, with $49.1 million global net product revenue through December 31, 2025.

 

   

Recorded 1,702 patient start forms, representing almost 20% of the US patient population, and activated 724 unique prescribers in the US through February 28, 2026.

 

   

In the fourth quarter of 2025, the majority of revenue was due to patients receiving refills of EKTERLY.

 

   

German launch is exhibiting similar characteristics to the US launch as adoption, utilization, and growth continue to build.

 

   

EKTERLY has launched in Japan through the Company’s partner, Kaken Pharmaceutical Co., Ltd., and has been listed on the National Health Insurance (NHI) drug reimbursement price list. EKTERLY is the first and only oral on-demand therapy available in Japan.


Clinical and Regulatory Progress

 

   

Completed enrollment in the Phase 3 KONFIDENT-KID trial of sebetralstat in pediatric HAE patients aged 2 to 11 years a full year ahead of schedule. New interim analysis data to be presented as a late-breaking oral presentation at the 2026 Global Angioedema Leadership Conference taking place in Madrid, Spain from March 26–29, 2026. KalVista expects to file a US new drug application in the third quarter of 2026 with a launch anticipated in 2027.

 

   

Announced recommendation of EKTERLY as a first-line therapy for adolescents 12 and older in the International Pediatric HAE Guideline, which emphasizes ensuring on-demand treatment is available anytime, anywhere, and prioritizing early self-administration.

 

   

Presented new sebetralstat clinical data at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting and the Western Society of Allergy, Asthma & Immunology (WSAAI) 63rd Annual Scientific Session, demonstrating high patient satisfaction, sustained effectiveness with repeat use and the importance of early treatment as the strongest predictor of symptom relief.

Transition Period Financial Results

 

   

Recognized $49.1 million in net product revenue for the eight months ended December 31, 2025.

 

   

Cost of revenue was $3.1 million for the eight months ended December 31, 2025.

 

   

Research and development expenses were $33.4 million and $52.2 million in the eight months ended December 31, 2025, and 2024, respectively. The decrease in R&D was primarily attributable to reduced clinical trial expenses and recognizing expenses associated with EKTERLY pre-commercial awareness within selling, general and administrative expenses.

 

   

Selling, general and administrative expenses were $124.7 million and $64.9 million in the eight months ended December 31, 2025, and 2024, respectively. The increase in SG&A was primarily attributable to commercialization expenses related to EKTERLY.

 

   

As of December 31, 2025, the Company had cash, cash equivalents and marketable securities of approximately $300.2 million. We anticipate that cash, cash equivalents and marketable securities as of December 31, 2025, along with projected revenues associated with the sale of EKTERLY will fund the Company through profitability.

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.

Investors:

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Media:

Molly Cameron

Sr. Director, Corporate Communications

(857) 356-0164

molly.cameron@kalvista.com


KALVISTA PHARMACEUTICALS, INC.

Consolidated Balance Sheets

(in thousands except share and per share amounts)

(Unaudited)

 

     December 31,
2025
    April 30,
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  

Filing Exhibits & Attachments

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Kalvista Pharm

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