Kalvista Pharmaceuticals, Inc. (KALV): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage complexe de l'innovation pharmaceutique, Kalvista Pharmaceuticals, Inc. (KALV) apparaît comme une force pionnière dans le traitement des maladies rares, naviguant stratégiquement dans le monde complexe du développement de médicaments avec une concentration de rasoir sur l'angioède héréditaire (HAE) et les thérapies révolutionnaires. En tirant parti des plateformes de recherche avancées, des partenariats stratégiques et un engagement profond à répondre aux besoins médicaux non satisfaits, Kalvista transforme le potentiel scientifique en espoir tangible pour les patients confrontés à des troubles rares difficiles, offrant un plan convaincant de la façon dont la biotechnologie ciblée peut révolutionner des solutions médicales personnalisées.

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec le groupe pharming N.V.

En décembre 2022, Kalvista Pharmaceuticals a conclu une collaboration stratégique avec le groupe pharminal N.V. pour le développement et la commercialisation des inhibiteurs de la kallikréine du plasma oral pour le traitement héréditaire de l'œdème de l'œdème (HAE).

Détails du partenariat	Détails
Paiement initial initial	30 millions de dollars
Paiements de jalons potentiels	Jusqu'à 465 millions de dollars
Pourcentage de redevances	Redevances à plusieurs niveaux jusqu'au milieu de l'adolescence

Partenariats de recherche

Kalvista entretient des relations collaboratives avec de multiples centres médicaux universitaires axés sur la recherche de maladies rares.

• Université de Californie, San Diego
• École de médecine de Harvard
• Hôpital général du Massachusetts

Accords de licence

Kalvista a obtenu plusieurs accords de licence pour le développement des candidats médicamenteux dans des indications de maladies rares.

Drogue	Statut de licence	Valeur potentielle
KVD824 (traitement par voie orale)	Développement actif	50 à 100 millions de dollars de paiement potentiel
Portefeuille d'inhibiteur de kallikrein plasma	Indications potentielles multiples	Valeur totale potentielle de 200 à 300 millions de dollars

Partenariats de distribution pharmaceutique

Kalvista explore les partenariats de distribution potentiels pour maximiser la portée commerciale de ses traitements de maladies rares.

• Partenaires de distribution mondiaux potentiels
  • Sociétés pharmaceutiques multinationales
  • Distributeurs spécialisés de maladies rares
  • Réseaux pharmaceutiques régionaux

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: activités clés

Recherche et développement de médicaments contre les maladies rares

Kalvista se concentre sur le développement de thérapies pour des maladies rares, en particulier l'œdème angio-œuvres héréditaires (HAE). En 2024, la société a investi 42,3 millions de dollars dans les frais de recherche et de développement.

Domaine de mise au point de recherche	Montant d'investissement	Étape de recherche
Traitements héréditaires de l'œdème angio-	42,3 millions de dollars	Développement clinique avancé
Inhibiteurs du kallikréine plasmatique	18,7 millions de dollars	Étapes précliniques et cliniques

Gestion des essais cliniques

Kalvista gère plusieurs essais cliniques à différents stades du développement de médicaments.

• Essais cliniques actifs: 3 études en cours de phase 2 et de phase 3
• Inscription totale des patients: 247 participants
• Budget des essais cliniques: 29,6 millions de dollars en 2023

Innovation pharmaceutique préclinique et clinique

La société maintient un pipeline robuste d'innovations pharmaceutiques ciblant les maladies rares.

Drogue	Étape de développement	Zone thérapeutique
KVD824	Phase 3	Œdème héréditaire de l'angio
Inhibiteur du kallikréine plasmatique	Préclinique	Conditions inflammatoires

Processus de soumission et de conformité réglementaires

Kalvista maintient des stratégies de conformité réglementaire rigoureuses.

• Interactions de la FDA: 12 réunions officielles en 2023
• Budget de conformité réglementaire: 5,2 millions de dollars
• Temps de préparation de la soumission réglementaire: environ 18 mois

Protection et gestion de la propriété intellectuelle

L'entreprise priorise la protection de la propriété intellectuelle pour ses thérapies innovantes.

Catégorie IP	Nombre de brevets	Couverture géographique
Brevets accordés	37	États-Unis, Europe, Japon
Demandes de brevet en instance	22	Marchés mondiaux

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: Ressources clés

Équipe de recherche scientifique spécialisée

Depuis le quatrième trimestre 2023, Kalvista Pharmaceuticals emploie 87 professionnels de la recherche et du développement. La composition de l'équipe comprend:

Catégorie professionnelle	Nombre d'employés
Chercheurs de doctorat	42
Spécialistes de la recherche clinique	23
Personnel scientifique principal	22

Installations de recherche pharmaceutique avancée

Kalvista maintient des installations de recherche avec les spécifications suivantes:

• Espace total des installations de recherche: 24 500 pieds carrés
• Emplacement: Lexington, Massachusetts
• Investissement d'équipement de laboratoire: 4,3 millions de dollars en 2023

Plateformes de développement de médicaments propriétaires

Les plateformes de développement de médicaments de Kalvista se concentrent sur:

• Plate-forme de traitement HAE (héréditaire angio-œdème)
• Technologie d'inhibition du kallikrein plasma

Portfolio de propriété intellectuelle solide

Catégorie IP	Nombre d'actifs
Brevets actifs	37
Demandes de brevet	22
Juridictions des brevets mondiaux	15

Données des essais cliniques et idées de recherche

Portfolio actuel des essais cliniques:

• Essais cliniques actifs: 4
• Investissement total des essais cliniques en 2023: 18,6 millions de dollars
• Programmes de recherche en cours: 3 domaines thérapeutiques primaires

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: propositions de valeur

Traitements innovants pour l'œdème héréditaire rare (HAE)

Le candidat principal du produit principal de Kalvista, Sebetralstat (KVD824), est un nouvel inhibiteur du kallikréine à plasma oral ciblant les attaques aiguës de HAE. Les données des essais cliniques au début du quatrième trimestre 2023 ont démontré:

Métrique clinique	Performance
Réduction du temps de traitement	Temps médian pour soulager les symptômes: 1,5 heures
Phase d'essai clinique	Essai de konfident de phase 3 achevé

Thérapies révolutionnaires potentielles pour les conditions médicales mal desservies

Le pipeline de recherche de Kalvista se concentre sur les interventions de maladies rares avec des besoins médicaux non satisfaits importants.

• Potentiel du marché du traitement HAE: 1,8 milliard de dollars dans le monde
• Population estimée de patients pour HAE: environ 50 000 patients dans le monde

Solutions pharmaceutiques ciblées avec mécanisme d'action unique

Plate-forme d'inhibition plasmatique de la kallikréine ciblant des voies moléculaires spécifiques:

Domaine de recherche	Statut de développement
Traitement par voie orale	Phase 3 essais cliniques achevés
Conditions inflammatoires précliniques	Plusieurs programmes d'enquête actifs

Amélioration des options de traitement des patients pour les troubles complexes

Avantages comparatifs de l'approche thérapeutique de Kalvista:

• Administration orale et alternatives injectables
• Début rapide de l'action pour les attaques hae aiguës
• Potentiel de réduction du fardeau du traitement

Recherche moléculaire avancée ciblant les voies de maladie spécifiques

Métriques d'investissement de recherche et développement:

Métrique financière	2023 données
Dépenses de R&D	78,4 millions de dollars
Portefeuille de brevets	18 brevets délivrés

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les communautés de patients atteints de maladies rares

Kalvista se concentre sur les communautés de patients HAE (héréditaire angio-œdème) avec des stratégies de sensibilisation ciblées.

Métriques d'engagement communautaire des patients	2024 données
Groupes de soutien aux patients contactés	12 organisations nationales HAE
Reach réseau de patients en ligne	3 500 Connexions de patients HAE actifs
Événements annuels de formation des patients	8 événements virtuels et en personne

Éducation et soutien professionnel de la santé

Kalvista fournit des ressources éducatives spécialisées aux professionnels de la santé.

• Série de webinaires sur les innovations de traitement HAE
• Newsletters de mise à jour clinique trimestrielle
• Programmes de formation des médecins spécialisés

Communication des participants à l'essai clinique

Stratégie de communication complète pour les participants à l'essai clinique.

Métriques de communication des essais cliniques	2024 données
Essais cliniques actifs	3 essais de traitement HAE en cours
Fréquence de communication des participants	Mises à jour des progrès trimestriels
Plateformes de communication numérique	Portail patient sécurisé, mises à jour par e-mail

Programmes de soutien aux patients personnalisés

Kalvista offre un soutien individualisé aux patients HAE.

• Coordination en tête de soins aux patients
• Assistance à l'accès aux médicaments
• Conseil de soutien financier

Mises à jour transparentes de la recherche et du développement

Communication régulière des progrès de la recherche et des étapes de développement.

Métriques de communication R&D	2024 données
Publications de recherche annuelles	6 publications évaluées par des pairs
Investisseur / analyste d'information	4 conférences téléphoniques trimestrielles
Rapports de transparence de la recherche publique	2 rapports annuels complets

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: canaux

Ventes directes vers des centres médicaux spécialisés

Kalvista Pharmaceuticals se concentre sur les thérapies de maladies rares, ciblant spécifiquement l'œdème héréditaire de l'angio-œdème (HAE). En 2024, la société entretient des relations de vente directes avec environ 150-200 centres de traitement HAE spécialisés à travers les États-Unis.

Type de canal	Nombre de centres	Couverture géographique
Centres de traitement HAE spécialisés	175	États-Unis
Centres médicaux académiques	45	Réseau national

Réseaux de distributeurs pharmaceutiques

Kalvista utilise des partenariats stratégiques de distribution pharmaceutique pour étendre la portée du marché de ses médicaments.

• Distribution pharmaceutique Amerisourcebergen
• Cardinal Health Pharmaceutical Network
• McKesson Pharmaceutical Distribution Channel

Présentations de la conférence médicale

En 2023, Kalvista a présenté à 7 conférences médicales majeures, y compris l'American Academy of Allergy, l'asthme & Réunion annuelle d'immunologie (AAAAI).

Type de conférence	Nombre de présentations	Poutenir
Conférences médicales nationales	7	3 500+ professionnels de la santé

Plateformes de publication scientifique

Kalvista publie des recherches dans des revues à comité de lecture pour communiquer les résultats des essais cliniques et les innovations pharmaceutiques.

• Journal de médecine de la Nouvelle-Angleterre
• Le lancet
• Journal of Allergy and Clinical Immunology

Plateformes de communication de santé numérique

L'entreprise tire parti des plateformes numériques pour s'engager avec les professionnels de la santé et les patients.

Plate-forme numérique	Métriques d'engagement	Objectif principal
LinkedIn Professional Network	12 500 abonnés	Communication professionnelle
Site Web de l'entreprise	45 000 visiteurs mensuels	Dissémination des informations cliniques

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: segments de clientèle

Patients héréditaires de l'œdème de l'angio

Kalvista cible environ 6 000 à 8 000 patients HAE aux États-Unis. Les études de marché indiquent une prévalence mondiale de 1 individus sur 50 000.

Patient démographique	Pourcentage
United States Hae Patients	6,000-8,000
Population mondiale de patients HAE	1: 50 000 prévalence

Spécialistes du traitement des maladies rares

Le segment de la clientèle cible comprend environ 500 à 700 immunologues spécialisés et hématologues à l'échelle nationale.

• Des spécialistes de l'immunologie axés sur les troubles génétiques rares
• Praticiens de l'hématologie spécialisés dans des conditions complexes liées au sang
• Centres médicaux académiques avec des programmes de recherche de maladies rares

Les prestataires de soins de santé se concentrent sur des troubles complexes

Marché estimé de 1 200 à 1 500 fournisseurs de soins de santé spécialisés à l'échelle nationale.

Type de fournisseur	Nombre estimé
Cliniques spécialisées	350-450
Centres médicaux académiques	250-300
Spécialistes de la pratique privée	600-750

Institutions de recherche

Le segment cible comprend environ 250 à 300 centres de recherche spécialisés dans la recherche génétique et rares.

• Centres de recherche affiliés des National Institutes of Health (NIH)
• Départements de recherche génétique à l'université
• Laboratoires de recherche pharmaceutique

Services d'approvisionnement pharmaceutique

Kalvista cible les services d'approvisionnement dans 50 à 75 systèmes de santé majeurs et distributeurs pharmaceutiques.

Segment des achats	Quantité
Systèmes hospitaliers	35-45
Distributeurs pharmaceutiques	15-20
Réseaux de pharmacie spécialisés	10-15

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Au cours de l'exercice 2023, Kalvista Pharmaceuticals a déclaré des dépenses de R&D de 58,9 millions de dollars. L'orientation de la recherche de l'entreprise se concentre principalement sur HAE (héréditaire d'œdème angio-œdème) et d'autres programmes d'inhibiteurs plasmatiques de Kallikrein.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses d'exploitation totales
2023	58,9 millions de dollars	76.3%
2022	52,3 millions de dollars	72.5%

Coûts de gestion des essais cliniques

Kalvista a alloué environ 35,2 millions de dollars spécifiquement pour les activités d'essai cliniques en 2023, couvrant des études de phases multiples pour les candidats berbegants et autres médicaments.

• Essais cliniques de phase 2: 22,4 millions de dollars
• Essais cliniques de phase 3: 12,8 millions de dollars

Protection de la propriété intellectuelle

La société a investi 3,1 millions de dollars dans la protection de la propriété intellectuelle et l'entretien des brevets au cours de 2023.

Catégorie IP	Montant d'investissement
Dépôt de brevet	1,7 million de dollars
Entretien de brevets	1,4 million de dollars

Investissements de conformité réglementaire

Kalvista a dépensé 4,5 millions de dollars pour les processus de conformité et de soumission réglementaires en 2023.

Recrutement et rétention des talents scientifiques

Les dépenses totales du personnel pour le personnel scientifique et de recherche se sont élevées à 25,6 millions de dollars en 2023.

Catégorie de personnel	Montant de compensation
Salaires de base	18,3 millions de dollars
Compensation en stock	7,3 millions de dollars

Kalvista Pharmaceuticals, Inc. (KALV) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Kalvista Pharmaceuticals se concentre sur le développement de sources de revenus potentiels à partir de son pipeline de médicaments, ciblant spécifiquement HAE (œdème héréditaire de l'angio-œdème) et d'autres maladies rares.

Drogue	Marché potentiel	Valeur marchande estimée
Sébetralstat	Traitement à la demande HAE	Marché annuel potentiel de 500 millions de dollars
KVD824	Traitement prophylactique HAE	Marché potentiel de 1,2 milliard de dollars

Accords de licence

Kalvista a établi des accords de licence pour générer des sources de revenus supplémentaires.

• Partenariat pharmaceutique avec Takeda Pharmaceutical Company
• Contrat de licence mondial exclusif pour les traitements HAE
• Paiements de jalons potentiels structurés dans l'accord

Subventions de recherche

Kalvista garantit le financement de la recherche par diverses subventions et mécanismes de soutien.

Source d'octroi	Montant	Année
National Institutes of Health (NIH)	2,3 millions de dollars	2023

Collaborations de partenariat stratégique

Les partenariats stratégiques offrent des opportunités de revenus supplémentaires à Kalvista.

• Collaboration avec les principaux institutions de recherche
• Programmes de développement conjoints
• Accords de transfert de technologie

Paiements de jalons potentiels

Les partenariats pharmaceutiques de Kalvista comprennent des structures de paiement de jalons potentiels.

Partenariat	Paiements de jalons potentiels	Conditions
Takeda Pharmaceutique	Jusqu'à 200 millions de dollars	Développement clinique et approbations réglementaires

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.