KalVista Pharmaceuticals (NASDAQ:KALV) detailed early commercial traction for EKTERLY, its oral on-demand treatment for hereditary angioedema (HAE), and reviewed financial results for an eight-month fiscal 2025 transition period during its latest earnings call. Management said the company’s fiscal year-end changed to December 31 from April 30, creating an eight-month reporting period from May 1, 2025 through December 31, 2025.
EKTERLY launch performance and early demand signals
Chief Executive Officer Benjamin Palleiko said 2025 was “pivotal,” citing the “successful multinational launch of EKTERLY” and describing high early adoption, rising physician engagement, and positive patient feedback since the U.S. launch in July 2025. KalVista reported $35 million in global net product revenue in the fourth quarter and $49 million in net product revenue from launch through December 31, 2025, which Palleiko said reflected “steady and consistent growth” in the first six months after launch.
KalVista repeatedly emphasized refill behavior as a key indicator of utilization. Palleiko and Hester said that by the fourth quarter, refills represented the majority of units and revenue, which management interpreted as evidence that patients who try EKTERLY continue using it to treat subsequent attacks.
- For January and February 2026, KalVista recorded 384 new start forms.
- Hester said the company is adding about three new prescribers per day on average, and recently logged 10 new prescribers in a single day.
- Hester said 29 of the top 30 HAE prescribers in the U.S. have prescribed EKTERLY for multiple patients.
On patient mix, Hester said adoption continues to increase in the “high burden” segment while also broadening to mild and moderate disease activity. In response to a question on penetration among high-burden patients, she said KalVista was “roughly around one-third” and continuing to grow quarter over quarter.
International rollout: Germany, Japan, and broader partnerships
KalVista said it is expanding EKTERLY access outside the U.S. Palleiko stated that Germany’s launch is “off to a strong start,” with early adoption tracking similarly to the U.S., though on a smaller base. On Japan, management said partner Kaken Pharmaceutical initiated launch activities after EKTERLY was listed on the National Health Insurance Reimbursement Schedule. In the Q&A, management noted that KalVista had its first sale in Japan “last week,” while cautioning it was too early to extrapolate trends.
On longer-term geographic revenue mix, management said the U.S. typically represents the majority of sales for pharmaceutical products and suggested an approximately 85%/15% split between U.S. and ex-U.S. sales over time, “plus or minus a few points.”
Clinical and real-world evidence: KONFIDENT extension and treatment preference
Chief Medical Officer Paul Audhya reviewed new analyses from the sebetralstat clinical program presented at Western and AAAAI meetings, including updated findings from the KONFIDENT open-label extension. He said sebetralstat showed consistent effectiveness in nearly 2,500 attacks treated through September 2025.
Audhya highlighted several utilization and satisfaction metrics from the longitudinal data:
- A second dose was used in 19.3% of treated attacks, with a decreasing trend to about 12% over repeated attacks.
- Use of “conventional injectable treatments” occurred in 5.1% of attacks, trending down toward 2%.
- 91.1% of attacks were rated “neutral to extremely satisfied,” with a median overall score of “very satisfied.”
Audhya also described a preference analysis from KONFIDENT, noting that participants could choose sebetralstat or their historical injectable for each attack. Under that design, he said patients chose sebetralstat for more than 84% of attacks, and preference increased over time as patients treated more attacks.
Separately, management said EKTERLY was recommended as a first-line treatment for adolescents ages 12 and older in an International Guideline on pediatric HAE, which the company said underscored the strength of its clinical data and highlighted the importance of early intervention.
Pediatric filing plans and short-term prophylaxis exploration
Looking ahead, Palleiko said KalVista plans to submit a pediatric NDA in the third quarter of 2026 seeking approval for children ages 2 to 11, which could support a potential U.S. launch in 2027.
Management also discussed potential use in short-term prophylaxis (STP) around procedures. Audhya said KalVista has seen STP use in “about 50 procedures” that were fairly invasive, with encouraging results so far, and expects to share data at an upcoming clinical conference. He added that KalVista is initiating an additional trial to evaluate STP use. Executives framed STP and pediatrics as opportunities to address unmet needs, but cautioned they are not positioning them as major revenue step-changes at this stage.
Financial results reflect transition to a commercial-stage company
Chief Financial Officer Brian said net product revenue for the eight-month transition period ended December 31, 2025 was $49.1 million, including $35.4 million in the three months ended December 31. He noted that fourth-quarter revenue benefited from specialty pharmacy customers adding inventory ahead of holiday shutdowns, which was “worked through in January.”
Total operating expenses were $160.2 million versus $117 million in the prior-year period comparison provided by the company. Cost of revenue was $3.1 million, and Brian explained that inventory sold in 2025 was not fully reflected in cost of revenue because it was manufactured prior to FDA approval and expensed to R&D at the time of production.
- R&D expense: $33.4 million vs. $52.2 million, driven by lower clinical trial costs as KONFIDENT wound down, reduced discovery activities, a medical affairs reclassification to SG&A, and capitalization of manufacturing costs after FDA approval.
- SG&A expense: $124.7 million vs. $64.9 million, driven primarily by commercial launch activities and infrastructure build-out.
- Operating loss: $112 million vs. $117 million.
KalVista ended the period with $300 million in cash and investments, which management said it believes is sufficient to fund the company to profitability under its current operating plan. Looking forward, Brian said operating expenses are expected to remain relatively consistent on a 12-month adjusted basis, except that cost of revenue is expected to increase meaningfully as KalVista sells through remaining zero-cost inventory.
In the Q&A, management said it is not providing guidance at this stage of the launch. Executives also cited seasonal and operational dynamics that can affect near-term metrics, including deductible resets and severe winter weather, which management said temporarily impacted physician office activity and start-form processing.
About KalVista Pharmaceuticals (NASDAQ:KALV)
KalVista Pharmaceuticals is a clinical‐stage biotechnology company focused on the discovery and development of small‐molecule protease inhibitors for orphan and specialty disease indications. The firm’s scientific platform centers on selective inhibition of plasma kallikrein, a serine protease implicated in disorders characterized by vascular leak, edema and inflammation. KalVista’s approach leverages oral and intravitreal delivery formats to target both systemic and ophthalmic conditions.
The company’s lead programs include an oral plasma kallikrein inhibitor in clinical trials for the acute treatment of hereditary angioedema (HAE) attacks and an intravitreal kallikrein inhibitor being evaluated for diabetic macular edema.
