KalVista Pharmaceuticals' EKTERLY Launch Marks a Pivotal Q1 2026
KalVista Pharmaceuticals (KALV -4.32%), a biopharmaceutical company developing and commercializing therapies for rare diseases, announced its earnings for the first quarter of fiscal 2026 on Sept. 11, 2025. The major headline was the commercial launch of EKTERLY (sebetralstat), the first and only oral treatment for acute hereditary angioedema (HAE) attacks, which received both U.S. Food and Drug Administration (FDA) and United Kingdom regulatory approval during the quarter. While early patient uptake exceeded management expectations, this achievement was accompanied by a significant surge in commercialization costs, highlighting both the scale of the market opportunity and the operational and financial challenges ahead. The quarter marked a major transition for the company as it moves from a research focus to commercial operations.
Q1 Fiscal 2026 Financial Performance
| Metric | Q1 Fiscal 2026 | Q1 Fiscal 2025 | Y/Y Change |
|---|
| EPS | $(1.12) | $(0.87) | N/A |
| Revenue | $1.4 million | $0 | N/A |
| R&D expense | $15.2 million | $26.6 million | (43%) |
| SG&A expense | $44.7 million | $17.6 million | 154% |
| Cash, cash equivalents & marketable securities | $191.5 million | $174.3 million | 9.9% |
Source: KalVista Pharmaceuticals. Note: Fiscal 2026's first quarter ended July 31, 2025. Fiscal 2025's Q1 ended July 31, 2024.
The Business and its Strategy
KalVista Pharmaceuticals is focused on treatments for rare diseases, specifically hereditary angioedema -- a genetic disorder that can cause severe and sometimes life-threatening swelling. EKTERLY, an oral plasma kallikrein inhibitor, is the company’s lead product. This drug aims to provide fast, convenient relief during HAE attacks and stands out for being the only oral option approved to date in a field previously dominated by injectable medications.
The company’s primary business focus is now on commercializing EKTERLY, particularly following its U.S. and U.K. regulatory approvals. Key priorities include increasing patient access, scaling up sales efforts, winning payer reimbursement, and preparing for further international expansion. Success will depend on its ability to translate strong early interest into filled prescriptions, secure insurance coverage, and expand to new geographies through additional approvals and partnerships.
Quarter in Review: Commercial Launch and Financial Developments
The company launched EKTERLY (oral on-demand therapy for hereditary angioedema) in the United States following FDA approval in July 2025. Within just eight weeks, it received 460 patient start forms (a measure of how many physicians initiated the paperwork needed to start patients on the medication). This represents nearly 5% of the reported HAE patient population in the U.S. This figure outpaced KalVista's own initial goals and signals substantial early demand within this rare disease community. However, KalVista did not specify how many of these start forms turned into ongoing prescriptions, which is a key step toward recurring revenue and broader patient adoption.
Revenue from EKTERLY in its first U.S. quarter reached $1.4 million -- its first-ever product sales. At the same time, the cost of revenue was $0.6 million for Q1 FY2026, newly reported as product sales commenced. Selling, general, and administrative (SG&A) expenses were $44.7 million -- up from $17.6 million a year earlier -- primarily due to commercialization expenses related to EKTERLY. Research and development (R&D) expenses for the quarter decreased to $15.2 million from $26.6 million in fiscal 2025's Q1, primarily due to reduced clinical trial expenses and the reclassification of EKTERLY pre-commercial awareness expenses to SG&A expenses.
Outside the U.S., KalVista advanced regulatory efforts in several markets. In July, the U.K. approved EKTERLY for HAE and granted orphan status. In Europe, the Committee for Medicinal Products for Human Use (CHMP) -- an arm of the European Medicines Agency -- issued a positive opinion on EKTERLY, with a final marketing decision expected from the European Commission in October 2025. Orphan designation in both the U.K. and Europe provides up to 10 years of market exclusivity, which is notable for protecting potential revenue streams as new geographies open up.
No new out-licensing deals or regional commercial agreements were announced this period, but prior arrangements remain in place. In Japan, a license with Kaken Pharmaceutical brings upfront and milestone payments, and Canada has similar partnership structures, supporting global expansion without heavy internal investment. There were no international commercial revenues yet this quarter, but the company is positioning for future launches with regulatory filings underway in the European Union, Japan, Australia, Singapore, and Switzerland.
Clinical and Financial Updates
EKTERLY’s clinical profile was further reinforced at several scientific meetings, with data showing median symptom relief in as little as 1.3 hours and a median end of attack progression of 19.8 minutes, closely aligning with its pivotal KONFIDENT trial as reported in the KONFIDENT-S study. The company continued pediatric studies (KONFIDENT-KID) and referenced ongoing efforts to broaden label indications, though with little new detail.
On the financial side, the company ended Q1 FY2026 with $191.5 million in cash, cash equivalents, and marketable securities, down from $220.6 million as of April 30, 2025. This cash “runway” is expected to cover the company into 2027, according to management. Net loss for the quarter widened to $60.1 million, compared to $40.4 million in the same period last year. The main driver of this was the commercialization costs associated with EKTERLY. Long-term liabilities increased to $136.3 million from $110.2 million for the quarter ended July 31, 2024. Operating loss also increased to $59 million from $44.2 million in the prior-year period.
This reflects accumulated losses and new long-term commitments as the company transitions from development-stage to commercial operations.
Looking Ahead: Guidance and Watchpoints
KalVista management did not provide specific financial guidance for the coming quarters, including no quantified forecasts for revenue, operating expenses, or market penetration. Previously, management had noted a cash runway into 2027, which remains unchanged based on the stated cash position at the end of the period. There was no update on when to expect revenue from outside the U.S. or on the pace of international launches, though regulatory milestones appear on track.
Going forward, investors should watch for U.S. prescription conversion rates, updates on payer reimbursement, progress toward European launch, and the ability to control commercialization expenses as sales ramp. International approvals, including a likely European Union decision in October 2025, could set up additional launches. The company’s current financial position supports continued operations, but also highlights the need to demonstrate sustained demand and margin improvement as EKTERLY expands into more markets. KALV does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
Industry Context and Competitive Landscape
KalVista operates in a competitive landscape of pharmaceutical companies targeting rare diseases. The hereditary angioedema (HAE) market, while niche, presents a significant opportunity due to the chronic and often debilitating nature of the condition. The approval and launch of EKTERLY provides KalVista with a first-mover advantage in the oral treatment segment, potentially disrupting a market traditionally reliant on injectable therapies. Competitors in the HAE space include companies offering injectable treatments and those developing alternative oral therapies. Factors that could impact KalVista's market share include the efficacy and safety profile of EKTERLY, its pricing and reimbursement strategy, and the availability of competing treatments.
The increasing focus on rare disease drug development globally, driven by regulatory incentives and unmet medical needs, suggests a favorable environment for KalVista. However, challenges remain in terms of patient identification, diagnosis, and access to specialized treatments. Collaboration with patient advocacy groups and healthcare providers will be crucial for KalVista to maximize the reach of EKTERLY and improve outcomes for HAE patients.
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