KalVista Pharmaceuticals, Inc. (KALV): Business Model Canvas [Dec-2025 Updated]

You're looking at KalVista Pharmaceuticals, Inc. right after they got that huge EKTERLY approval, and honestly, the business model canvas tells a clear story: this defintely isn't just an R&D shop anymore. We're seeing a company with $220.6 million in the bank as of April 30, 2025, now pivoting hard into the commercial game with a direct U.S. sales force, while still managing global partnerships for ex-US markets. To truly understand the near-term risk-balancing those $116.3 million in G&A expenses for FY 2025 against the initial $1.4 million in net product revenue from Q1 FY 2026-you need to see how all nine building blocks fit together now that they have a product on the street. Dive into the breakdown below to see the full strategic picture.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Key Partnerships

You're looking at the partnerships KalVista Pharmaceuticals, Inc. has put in place to get EKTERLY (sebetralstat) to market globally. These alliances are crucial because they handle the heavy lifting of regional regulatory navigation and sales, letting KalVista Pharmaceuticals focus on its pipeline and US launch.

Licensing agreement with Kaken Pharmaceutical for Japan commercialization

KalVista Pharmaceuticals entered an exclusive agreement with Kaken Pharmaceutical, Co., Ltd. in April 2025 to commercialize sebetralstat in Japan. This deal is a significant non-US revenue driver.

The financial structure of this partnership includes specific, dated payments:

• Upfront payment received in June 2025: $11 million.
• Additional payment upon achieving a regulatory milestone anticipated in early 2026: up to $11 million.
• Potential commercial milestone payments: up to $2 million.
• Total potential upfront and milestone payments: $24 million.
• Royalties: expected to be in the mid-twenties as a percentage of sales, based on the Japan National Health Insurance (NHI) price.

Exclusive rights granted to Pendopharm for Canadian commercialization

On June 26, 2025, KalVista Pharmaceuticals granted Pendopharm, a division of Pharmascience Inc., the exclusive rights for regulatory approval and commercialization of sebetralstat in Canada. This move leverages Pendopharm's deep knowledge of the Canadian market.

What this estimate hides is that the specific financial terms of this agreement are not being disclosed publicly. Still, the goal is to bring EKTERLY to Canadian patients as the first oral on-demand treatment for hereditary angioedema (HAE).

Here's a quick look at the key commercialization partnerships:

Partner	Territory	Product Rights Granted	Upfront Payment (USD)	Royalty Structure
Kaken Pharmaceutical, Co., Ltd.	Japan	Commercialization	$11 million	Mid-twenties percentage of sales
Pendopharm (Pharmascience Inc. division)	Canada	Regulatory Approval and Commercialization	Undisclosed	Undisclosed

Contract Manufacturing Organizations (CMOs) for EKTERLY production

While specific CMO names aren't public, the operational costs reflect manufacturing activity post-approval. Cost of revenue for the three months ended September 30, 2025, was $1.2 million, which included EKTERLY manufacturing and inventory overhead costs incurred after US approval. For the three months ended July 31, 2025, this cost was $0.6 million. This suggests a variable cost structure tied to the commercial launch volume.

Global regulatory bodies (FDA, EMA, MHRA) for market access

Regulatory clearance is the primary gatekeeper for revenue generation. KalVista Pharmaceuticals has secured several key approvals for EKTERLY:

• FDA Approval: Granted on July 7, 2025. The PDUFA goal date was June 17, 2025.
• MHRA (UK) Authorization: Granted in July 2025.
• European Medicines Agency (EMA): Marketing Authorization Application (MAA) validation received in August 2024.
• EU and Switzerland Approvals: Received as of the third quarter ended September 30, 2025.
• Australia Approval: Received as of the third quarter ended September 30, 2025.
• Total Regulatory Approvals: Five as of September 30, 2025.

The US wholesale price for EKTERLY is set at $16,720 per dose (two tablets). A standard package contains two doses, costing $33,440.

Academic and clinical research institutions for pipeline development

Partnerships with research institutions underpin the data supporting EKTERLY and future pipeline assets. The Phase 3 KONFIDENT clinical trial, which established the drug's efficacy, randomized 136 HAE patients from 66 clinical sites across 20 countries. Furthermore, KalVista Pharmaceuticals presented new data at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13-16, 2025.

Finance: draft 13-week cash view by Friday.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Key Activities

You're looking at the core engine room of KalVista Pharmaceuticals, Inc. right now, post-launch. The key activities are all about shifting from pure R&D to commercial execution while keeping the pipeline moving. It's a delicate balance, and the numbers tell the story of that transition.

Commercial launch and marketing of EKTERLY (sebetralstat) in the U.S.

The primary activity is driving the commercialization of EKTERLY (sebetralstat) following its landmark approval. KalVista Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval on July 7, 2025. The U.S. commercial launch started on the very same day, July 7, 2025.

Early demand signals are strong, which is what you want to see when you transition to a commercial entity. For the period ended August 29, 2025, KalVista Pharmaceuticals, Inc. received 460 patient start forms. That figure represents nearly 5% of the reported U.S. Hereditary Angioedema (HAE) patient population.

Financially, the initial revenue capture for the quarter ended July 31, 2025, was $1.4 million in net product revenue from U.S. sales, with the drug becoming commercially available in mid-July. The associated cost of revenue, which includes manufacturing and inventory overhead incurred post-approval, was $0.6 million for that same three-month period. The commercial push is reflected in the Selling, General and Administrative (SG&A) expenses, which hit $44.7 million for the three months ended July 31, 2025, a significant jump from $17.6 million the prior year. Management sees the total market opportunity for EKTERLY at $1.5 billion, with peak sales estimated by Jefferies analyst Maury Raycroft to reach $700 million.

Ongoing global regulatory submissions for sebetralstat (six submissions underway)

KalVista Pharmaceuticals, Inc. is actively managing the global rollout. As of the fiscal year ended April 30, 2025, there were six additional global regulatory submissions under review. The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom granted marketing authorization in July 2025. For the European Union, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, with the European Commission final decision anticipated in October 2025. This sets up the first EU launch, expected in Germany in Q4 2025.

International partnership activity is also a key activity here, securing future revenue streams.

Territory/Partner	Key Financial/Regulatory Event	Amount/Date
Japan (Kaken Pharmaceutical)	Upfront payment received in June 2025	$11 million
Japan (Kaken Pharmaceutical)	Additional payment anticipated upon regulatory milestone	$11 million
Japan (Kaken Pharmaceutical)	Royalties expected as a percentage of sales	Mid-twenties percent
Canada (Pendopharm)	Exclusive rights granted for regulatory and commercialization	Undisclosed terms

Research and development (R&D) of the Factor XIIa inhibitor program

Even with the commercial focus, R&D continues, though spending has shifted. Research and development expenses for the fiscal year ended April 30, 2025, totaled $71.7 million, a decrease from $86.2 million in fiscal year 2024. For the most recent reported quarter ending July 31, 2025, R&D spending was $15.2 million, down from $26.6 million in the same period of 2024. This reduction is attributed to lower clinical trial expenses and the reclassification of certain EKTERLY pre-commercial awareness costs into SG&A. The development strategy for the Factor XIIa program was refined for fiscal year 2025.

Managing global supply chain and drug inventory

The shift to commercial sales necessitates managing the supply chain for EKTERLY production and inventory overhead. The cost of revenue recognized in the first quarter of commercial sales (three months ended July 31, 2025) included $0.6 million in EKTERLY manufacturing and inventory overhead costs. The company's cash position reflects the funding required for this scale-up, holding $220.6 million in cash, cash equivalents, and marketable securities as of April 30, 2025, which decreased to approximately $191.5 million by July 31, 2025.

Post-marketing surveillance and lifecycle extension (e.g., ODT formulation)

Lifecycle management is already underway to expand the utility of sebetralstat. This involves ongoing trials for different patient populations and formulations.

• The KONFIDENT-KID trial is evaluating EKTERLY in pediatric patients aged 2 to 11 years using an orally disintegrating tablet (ODT) formulation.
• KalVista Pharmaceuticals, Inc. planned to transition participants in the KONFIDENT-S trial to the ODT formulation in Q4 2024.
• This ODT formulation supports a planned supplemental New Drug Application (sNDA) filing anticipated by mid-2026.

In the UK, EKTERLY received Orphan Designation, granting up to 10 years of market exclusivity upon addition to the Orphan Register.

Finance: Finance needs to confirm the cash runway projection based on the $191.5 million cash balance as of July 31, 2025, which management stated covers the company into 2027.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Key Resources

You're looking at the core assets KalVista Pharmaceuticals, Inc. (KALV) relies on to drive its business, especially now that EKTERLY is on the market. These aren't just abstract concepts; they are the tangible and intangible things that make the value proposition possible.

The most critical resource is EKTERLY (sebetralstat) itself, which represents the first and only oral on-demand HAE therapy. This shifts the treatment paradigm away from injectables, which is a massive value driver for patients. The U.S. Food and Drug Administration (FDA) approval came on July 8, 2025, for acute attacks in people 12 years of age and older.

Underpinning this product is the Intellectual Property (IP) protecting the plasma kallikrein inhibitor platform. KalVista has a history of patent filings covering enzyme inhibitors and specific solid forms of the compound. As of January 2024, the company's grant share, based on the ratio of grants to total patents, stood at 42%. This IP fortress is what secures their first-mover advantage in the oral on-demand space.

Financial strength is a key resource, especially post-launch. You need capital to fund the commercial build-out. KalVista reported cash, cash equivalents, and marketable securities of $220.6 million as of April 30, 2025. To give you a more current view, cash, cash equivalents and restricted cash was reported at $124,964 thousand as of September 30, 2025. The investment in the specialized commercial sales force focused on U.S. HAE specialists is reflected in the Selling, general and administrative expenses, which reached $46.5 million for the three months ended September 30, 2025.

The foundation of the regulatory approval and commercial confidence rests on the Clinical data from the Phase 3 KONFIDENT trial. This trial was the largest ever conducted in HAE, randomizing 136 participants. The data clearly demonstrated the superiority of EKTERLY over placebo for the primary endpoint of time to beginning of symptom relief.

Here's a quick look at the key efficacy numbers from the KONFIDENT trial:

Dose/Group	Median Time to Beginning of Symptom Relief (Hours)	Attack Resolution by 24 Hours (%)
EKTERLY 300 mg	1.61	42.5%
EKTERLY 600 mg	1.79	49.5%
Placebo	6.72	27.4%

Furthermore, the open-label extension, KONFIDENT-S, provided real-world evidence, showing that for 1,089 attacks treated by patients who switched from injectables, 84% of attacks were rated as satisfied. This clinical proof is a non-negotiable asset for market adoption.

Also, note the strategic partnerships that extend the resource base globally. KalVista entered an exclusive agreement with Kaken Pharmaceutical in Japan, receiving an upfront payment of $11 million in June 2025, and another with Pendopharm for Canadian rights. These deals provide non-dilutive capital and commercial reach outside the U.S. focus.

• EKTERLY is approved in the United States, European Union, United Kingdom, Switzerland, and Australia.
• Interim data from the pediatric trial, KONFIDENT-KID, showed a median time to symptom relief of 1.5-hours in pediatric patients.
• The company had 50,523,274 shares of common stock issued and outstanding as of August 29, 2025.

Finance: draft 13-week cash view by Friday.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Value Propositions

You're looking at the core reason KalVista Pharmaceuticals, Inc. is making waves in the rare disease space; it all boils down to what EKTERLY (sebetralstat) offers patients who live with Hereditary Angioedema (HAE). This isn't just another drug; it's a fundamental shift in how acute attacks are managed.

First and only oral, on-demand treatment for acute HAE attacks (EKTERLY).

EKTERLY is the first and only oral on-demand treatment approved for acute HAE attacks in people aged 12 years and older across several major markets. You see approvals in the United States, the European Union, the United Kingdom, and Switzerland as of late 2025. This oral route is the holy grail for many HAE patients who previously relied on injections. The company posted net product revenue of $13.7 million for the third quarter ending September 30, 2025. For context on pricing, the wholesale price is set at $16,720 per dose (two tablets), meaning a package containing two doses costs $33,440.

Enhanced patient convenience and adherence over injectable therapies.

The burden of injectable therapies is significant, and the data clearly shows patients want out. A cross-sectional survey highlighted that a staggering 86% of patients reported delaying or avoiding injectable on-demand treatment administration. The reasons are concrete: 28% cited injection aversion, and 27% cited lack of privacy. Honestly, when you have a treatment that removes the needle, adherence naturally improves. In fact, 89% of patients surveyed expressed a preference for an oral on-demand treatment. For those who have already switched, the patient satisfaction is high; in the KONFIDENT-S study, 84% of treated attacks were rated as satisfied, very satisfied, or extremely satisfied by patients switching from injectables. To be fair, in Germany, 53% of respondents still experienced injection site reactions with their previous therapies.

Rapid and consistent symptom relief for HAE attacks.

Speed matters when an attack hits, especially those involving the larynx or abdomen. EKTERLY offers what is described as injectable-like efficacy through a convenient pill. Here's a quick look at the timing metrics from the clinical data:

Metric	Data Point	Study/Context
Median Time to Dosing (Pediatrics)	30-minutes	KONFIDENT-KID interim results
Median Time to Symptom Relief (Pediatrics)	1.5-hours	KONFIDENT-KID interim results
Median Time to Symptom Relief (Larynx/Abdomen)	1.3 hours	Phase 3 extension study
Median Time to Treatment (Europe)	16 minutes (10 minutes in adolescents 12-17)	KONFIDENT-S
Median Time to Symptom Relief (Europe)	1.6 hours	KONFIDENT-S

The ability to treat attacks when they are still mild is a key benefit, as 35% of attacks in the KONFIDENT-S trial were still mild at the time of sebetralstat treatment.

Treatment for a rare disease (HAE) with significant unmet medical need.

HAE is definitely a rare disorder, affecting roughly 1 in 10,000 to 1 in 50,000 people globally. The market reflects this high-value, low-incidence patient base. The global Hereditary Angioedema Therapeutics Market size was valued at USD 5.86 billion in 2025. Analysts project this market will grow to USD 12.79 billion by 2030, showing a strong 16.9% CAGR. Furthermore, a vast patient pool exists with unmet needs, partly because many patients are initially misdiagnosed with conditions like appendicitis or gastrointestinal disorders. Early US launch traction shows this need; KalVista received 460 patient start forms in the first eight weeks post-FDA approval on July 7, 2025, representing almost 5% of the reported US HAE patient population at that time.

The value proposition is further supported by the following patient characteristics:

• HAE is typically characterized by unpredictable flares.
• Attacks can affect the throat (airways), face, hands, and feet.
• The disorder is potentially life-threatening.
• Pediatric data suggests a higher attack frequency than previously thought.

Potential for a foundational therapy in HAE management worldwide.

The market sees EKTERLY as a potential game-changer, moving beyond existing rescue therapies. Analysts project peak sales of about $470 million across the U.S. and Europe. However, KalVista Pharmaceuticals, Inc. itself sees a larger market opportunity for EKTERLY, estimating it at $1.5 billion. The company anticipates that cash on hand as of September 30, 2025, which was approximately $309.2 million, along with projected EKTERLY revenues, will fund the company through profitability. The first-mover advantage is key to holding share in this evolving market, especially as the company pursues approval for its orally disintegrating tablet formulation for children aged 2 to 11.

Finance: draft 13-week cash view by Friday.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Customer Relationships

You're launching a first-in-class oral therapy for a rare disease, so the relationship with the Hereditary Angioedema (HAE) community isn't just important; it is the foundation of your commercial success. KalVista Pharmaceuticals, Inc. has clearly prioritized deep, empathetic engagement across the entire patient ecosystem.

High-touch engagement with HAE patient advocacy and support groups.

KalVista Pharmaceuticals, Inc. has woven community feedback directly into its strategy. The perspective of the HAE community is at the heart of everything the company does, which is a necessary stance when bringing a novel oral treatment to market. The company specifically acknowledged the steadfast collaboration and commitment from advocacy organizations like the HAEA and HAEi, recognizing their role in making the EKTERLY® (sebetralstat) approval possible. This high-touch approach is evidenced by the presentation of new patient satisfaction data at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting.

Patient services programs to ensure timely access and reimbursement.

Innovation is only half the battle; access is critical, especially in rare disease treatment. To address this, KalVista Pharmaceuticals, Inc. launched KalVista Cares, a comprehensive patient support program in the U.S.. This program is designed to guide patients through the entire treatment journey, which includes navigating insurance complexities, receiving personalized services, and securing financial assistance. The goal is to make care easier, more accessible, and less stressful for the patient population.

Dedicated medical affairs and field teams for physician education.

The commercial relationships with prescribing physicians are being driven by a focused field presence following the July 7, 2025, FDA approval of EKTERLY®. The commercial team is actively engaging to educate and activate physicians to support informed treatment decisions. The success of this engagement is quantifiable through early adoption metrics, showing strong initial community uptake across all HAE patient segments, including prophylaxis users and adolescents.

Here's a quick look at the initial commercial relationship traction as of late 2025:

Metric	Value/Period	Source Context
Patient Start Forms Received (Cumulative)	937 (Less than 4 months post-launch)	Q3 2025 Update
Estimated HAE Community Penetration	More than 10%	Q3 2025 Update
Net Product Revenue (US Sales)	$1.4 million (Three months ended July 31, 2025)	Q3 2025 Financials
Attacks Treated with EKTERLY (KONFIDENT-S Trial)	Over 2,700 (As of October 31, 2025)	Q3 2025 Update

The German launch is also underway, validating the ex-U.S. interest in the oral therapy.

Direct relationship management with key opinion leaders (KOLs) in immunology.

Managing relationships with Key Opinion Leaders (KOLs) is crucial for establishing a new standard of care. KalVista Pharmaceuticals, Inc. has leadership with deep expertise in this area. For instance, the Chief Medical Officer, Paul K. Audhya, M.D., MBA, brings experience in global medical affairs and international product launches, having previously served in a similar role at Arena Pharmaceuticals. The company supports these relationships by presenting robust clinical data, such as patient satisfaction scores from the KONFIDENT-S trial and pediatric data from KONFIDENT-KID, at major medical congresses like the ACAAI 2025 meeting.

The focus of these KOL interactions centers on demonstrating the value proposition:

• High treatment satisfaction score of 2 (very satisfied) on a 7-point scale for patients switching from injectables.
• Rapid time to symptom relief, with a median of 1.5 hours in the 150 mg pediatric cohort.
• Addressing the substantial unmet need for convenient, non-injectable options.

Finance: review Q4 2025 cash burn projection by next Tuesday.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Channels

You're looking at how KalVista Pharmaceuticals, Inc. gets its first commercial product, EKTERLY (sebetralstat), into the hands of Hereditary Angioedema (HAE) patients as of late 2025. The channel strategy is clearly segmented between the direct U.S. effort and leveraging established partners internationally.

Direct KalVista Pharmaceuticals, Inc. commercial sales force in the U.S.

KalVista Pharmaceuticals, Inc. initiated the U.S. commercial launch of EKTERLY on July 7, 2025. This required an immediate ramp-up of commercialization activities, reflected in the Selling, general and administrative expenses (SG&A) jumping to $44.7 million for the three months ended July 31, 2025, compared to $17.6 million in the same period of 2024. The initial market penetration shows real traction; the company received 460 patient start forms for the period ending August 29, 2025. Honestly, that represents almost five percent of the reported HAE patient population in the US in just eight weeks post-launch. The company is definitely using its internal team to drive this initial adoption curve.

The early commercial success is evident in the financials, with Q3 2025 net product revenue hitting $13.69 million. This revenue stream is entirely dependent on the efficiency of the newly established U.S. channel.

Specialty pharmacies and distributors for drug delivery.

For a rare disease product like EKTERLY, distribution relies on a focused specialty pharmacy network, often referred to as limited distribution. KalVista Pharmaceuticals, Inc. selected a specific group of specialty pharmacies to manage dispensing and patient services for EKTERLY.

Here's the breakdown of the confirmed specialty pharmacy partners:

• CVS Specialty
• Accredo
• Optum
• Orsini, which was selected on July 7, 2025.

The use of these established specialty pharmacies helps manage the complex logistics of a rare disease drug, ensuring patients receive comprehensive support alongside their medication.

International licensing partners (Kaken, Pendopharm) for ex-US markets.

KalVista Pharmaceuticals, Inc. is using licensing agreements to access ex-US markets, which is a classic biotech channel strategy for global reach without building out separate infrastructure everywhere.

The key international channel agreements as of late 2025 are:

Partner	Market	Agreement Date/Payment Event	Financial Detail
Kaken Pharmaceutical, Co., Ltd.	Japan	Upfront payment received in June 2025.	$11 million upfront payment; additional $11 million upon regulatory milestone in early 2026. Royalties expected in the mid-twenties as a percentage of sales.
Pendopharm (division of Pharmascience Inc.)	Canada	Exclusive rights granted in June 2025.	Financial terms are not disclosed.

The agreement with Kaken also includes potential commercial milestone payments up to $2 million.

Medical conferences (e.g., EAACI 2025) for data dissemination.

Disseminating clinical data is a crucial channel for driving physician awareness and adoption, especially for a newly approved therapy. KalVista Pharmaceuticals, Inc. actively presented data at major medical meetings. The company presented new data at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 in Glasgow, UK, between June 13-16, 2025, where six scientific abstracts were accepted. Furthermore, data on pediatric use and patient satisfaction were presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting in November 2025.

For instance, the interim analysis from KONFIDENT-S, presented at EAACI 2025, detailed that for 1,089 attacks treated by patients who switched from injectable on-demand treatments, 84% were rated as satisfied.

Finance: draft 13-week cash view by Friday.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Customer Segments

Hereditary Angioedema (HAE) patients aged 12 years and older represent the core patient segment for EKTERLY (sebetralstat), which received FDA approval on July 7, 2025, for acute attacks in this population.

The initial commercial uptake in the US has been strong, with 460 patient start forms received for the period ended August 29, 2025. This early demand represented almost five percent of the reported HAE patient population in the US as of that date.

The addressable patient pool size is derived from HAE prevalence data across key markets:

Region	Estimated Prevalence Metric	Associated Patient Number/Range	Data Year/Context
Global	Pooled Prevalence	1.22 cases per 100,000 people (95% CI: 0.91, 1.53)	2025 (Meta-analysis data)
Global	General Incidence	1 in 50,000 people worldwide	2025
United States	Claims-Based Estimate (All Types)	8,694 diagnosed people (2.43 per 100,000)	2020
United States	Expert Physician Estimate (All Types)	6,595 diagnosed people (1.84 per 100,000)	2020
United States	HAEA Registry Monitoring	7,000 patients monitored	2025
EU5 + Japan (7MM)	Total Diagnosed Prevalent (2017)	14,435 cases	2017

The treatment is indicated for patients aged 12 years and older.

Allergists and Immunologists specializing in HAE treatment are critical prescribers, as EKTERLY is the first oral on-demand therapy, offering an alternative to existing injectable treatments. The treatment guidelines reinforce that all patients should be trained in self-administration of on-demand treatment. The oral formulation is positioned to allow for earlier treatment of all HAE attacks.

Payers and government health authorities, including private insurers and Medicare, determine market access. The availability and extent of reimbursement by these payors are essential for patient affordability. The Inflation Reduction Act ("IRA") enacted in August 2022 will eliminate the coverage gap under Medicare Part D beginning in 2025, requiring manufacturers to subsidize 10% of Part D enrollees' prescription costs for brand drugs below the out-of-pocket threshold.

International patient populations are targeted across approved and pending markets.

• United Kingdom (UK): Received marketing authorization from the MHRA in July 2025.
• European Union (EU): Received a positive opinion from the CHMP in July 2025, with the final European Commission decision expected in October 2025.
• Japan: KalVista entered an exclusive commercialization agreement with Kaken Pharmaceutical in April 2025, receiving an upfront payment of $11 million in June 2025. An additional $11 million is anticipated upon achieving a regulatory milestone in early 2026.
• Canada: Commercial partners are in place.

The global HAE drugs market was valued at an estimated USD 3.13 Bn in 2025.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Cost Structure

You're looking at the cost side of KalVista Pharmaceuticals, Inc. (KALV) as they transition from a pure-play R&D firm to a commercial entity with the EKTERLY (sebetralstat) launch. This shift dramatically changes the cost profile, moving significant spending into selling, general, and administrative (SG&A) areas.

The full fiscal year ended April 30, 2025, shows the scale of the pre-commercial investment. General and administrative (G&A) expenses reached $116.3 million for FY 2025, a big jump from $54.3 million in the prior year, primarily driven by pre-commercial planning for EKTERLY.

Research and development (R&D) expenses for FY 2025 were $71.7 million. This was actually a decrease from $86.2 million in FY 2024, which the company attributed to reduced clinical trial expenses and preclinical activities, plus some activities moving into the G&A bucket as pre-commercial awareness costs. Still, R&D remains a major cost center.

The most immediate view of the cost structure comes from the first fiscal quarter of FY 2026 (ended July 31, 2025), which captures the immediate impact of the U.S. commercial launch. Total operating expenses for that quarter were substantial at $60.4 million.

This quarter clearly illustrates the significant commercialization and sales force build-out costs you asked about. Selling, general and administrative (SG&A) expenses surged to approximately $45 million for the three months ended July 31, 2025, up from $17.6 million in the same period last year. Honestly, this SG&A spike is the cost of bringing EKTERLY to market.

Manufacturing and inventory overhead costs are now appearing as Cost of Revenue, which was reported as $0.6 million for the three months ended July 31, 2025. This is the first time Cost of Revenue was recognized, as no product sales occurred in the prior year period.

The R&D spending in Q1 FY 2026 was about $15.2 million, showing a continued, though lower, investment in pipeline work. Lifecycle extension activities, such as the pediatric trial (KONFIDENT-KID) using an orally disintegrating tablet formulation, are part of this ongoing R&D spend, though the overall R&D spend decreased year-over-year for the full FY 2025.

Here's a quick look at how the major expense categories stacked up for the full FY 2025 and the initial commercial quarter of FY 2026:

Cost Category	FY Ended April 30, 2025 (Full Year)	Q1 FY 2026 (Three Months Ended July 31, 2025)
General & Administrative (G&A) / SG&A	$116.3 million	$44.7 million
Research & Development (R&D)	$71.7 million	$15.2 million
Cost of Revenue (Manufacturing/Inventory Overhead)	Not explicitly stated for full year	$0.6 million

You should note the shift in focus:

• Pre-commercial planning expenses were a major driver of the FY 2025 G&A increase.
• The Q1 FY 2026 SG&A is directly attributable to commercialization expenses related to the EKTERLY launch.
• The company received an upfront payment of $11 million in June 2025 from Kaken for Japan rights, which helps offset costs, but the operational burn rate is high now.
• Cash, cash equivalents, and marketable securities stood at $191.5 million as of July 31, 2025, providing runway into 2027, which is key given these high operating costs.

Finance: draft 13-week cash view by Friday.

KalVista Pharmaceuticals, Inc. (KALV) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for KalVista Pharmaceuticals, Inc. as of late 2025, which are heavily weighted toward the recent commercial launch of EKTERLY and existing partnership structures. This is where the money comes from to fund the next phase of growth.

The primary, immediate revenue driver is the newly launched product, EKTERLY (sebetralstat), which is the first and only oral on-demand treatment for acute attacks of hereditary angioedema (HAE).

Net product revenue from U.S. sales of EKTERLY started strong, with the company recognizing $1.4 million in net product revenue for the three months ended July 31, 2025, which was KalVista Pharmaceuticals, Inc.'s first quarter of meaningful product sales following the U.S. commercial launch in July 2025.

Beyond direct product sales, KalVista Pharmaceuticals, Inc. secures cash through international licensing deals, which provide non-dilutive funding. A key example is the agreement with Kaken Pharmaceutical for commercialization rights in Japan.

This partnership generated immediate cash flow:

• Upfront payments from international licensing agreements included $11 million received from Kaken in June 2025.

The structure of these deals also builds in future, contingent revenue streams based on performance metrics:

Revenue Type	Partner/Territory	Specific Amount/Rate
Regulatory Milestone Payment	Kaken (Japan)	Additional $11 million anticipated in early 2026
Commercial Milestone Payments	Kaken (Japan)	Up to $2 million or up to approximately $13.0 million total in regulatory and sales milestones
Royalties on Net Sales	Kaken (Japan)	Expected to be in the mid-twenties percentage of sales based on the Japan National Health Insurance (NHI) price

The Factor XIIa inhibitor program represents potential future revenue, though the current focus has shifted to prioritize the commercialization of EKTERLY. Following a strategic review, KalVista Pharmaceuticals, Inc. planned to reduce spending on discovery and preclinical activities for this program by more than 75%, aiming for less than $5 million per year.

The revenue streams can be summarized by their source type:

• Net product revenue from U.S. sales of EKTERLY: $1.4 million in Q1 FY 2026.
• Upfront payments from international licensing agreements: $11 million from Kaken in June 2025.
• Regulatory and commercial milestone payments from partners: Up to $13.0 million total from Kaken milestones.
• Royalties on net sales from licensed territories: Mid-twenties percentage in Japan.
• Potential future revenue from pipeline assets like the Factor XIIa inhibitor: Spending on this program was targeted to be less than $5 million per year.

Finance: draft 13-week cash view by Friday.