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

In der komplexen Landschaft der pharmazeutischen Innovation erweist sich KalVista Pharmaceuticals, Inc. (KALV) als Vorreiter in der Behandlung seltener Krankheiten und navigiert strategisch durch die komplexe Welt der Arzneimittelentwicklung mit einem messerscharfen Fokus auf hereditäres Angioödem (HAE) und bahnbrechende Therapien. Durch die Nutzung fortschrittlicher Forschungsplattformen, strategischer Partnerschaften und eines starken Engagements für die Bewältigung ungedeckter medizinischer Bedürfnisse verwandelt KalVista wissenschaftliches Potenzial in greifbare Hoffnung für Patienten, die mit schwierigen seltenen Erkrankungen konfrontiert sind, und bietet einen überzeugenden Plan dafür, wie gezielte Biotechnologie personalisierte medizinische Lösungen revolutionieren kann.

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Pharming Group N.V.

Im Dezember 2022 ging KalVista Pharmaceuticals eine strategische Zusammenarbeit mit der Pharming Group N.V. zur Entwicklung und Vermarktung oraler Plasma-Kallikrein-Inhibitoren zur Behandlung des hereditären Angioödems (HAE) ein.

Einzelheiten zur Partnerschaft	Besonderheiten
Erste Vorauszahlung	30 Millionen Dollar
Mögliche Meilensteinzahlungen	Bis zu 465 Millionen US-Dollar
Lizenzgebührenprozentsatz	Gestaffelte Lizenzgebühren bis zur Mitte des Zehnjahreszeitraums

Forschungspartnerschaften

KalVista unterhält Kooperationsbeziehungen mit mehreren akademischen medizinischen Zentren, die sich auf die Erforschung seltener Krankheiten konzentrieren.

• Universität von Kalifornien, San Diego
• Harvard Medical School
• Massachusetts General Hospital

Lizenzvereinbarungen

KalVista hat mehrere Lizenzvereinbarungen für die Entwicklung von Medikamentenkandidaten für seltene Krankheitsindikationen abgeschlossen.

Arzneimittelkandidat	Lizenzstatus	Potenzieller Wert
KVD824 (Orale HAE-Behandlung)	Aktive Entwicklung	Mögliche Meilensteinzahlungen in Höhe von 50–100 Millionen US-Dollar
Plasma-Kallikrein-Inhibitor-Portfolio	Mehrere mögliche Indikationen	200–300 Millionen US-Dollar potenzieller Gesamtwert

Pharmazeutische Vertriebspartnerschaften

KalVista prüft mögliche Vertriebspartnerschaften, um die kommerzielle Reichweite seiner Behandlungen für seltene Krankheiten zu maximieren.

• Potenzielle globale Vertriebspartner
  • Multinationale Pharmaunternehmen
  • Spezialhändler für seltene Krankheiten
  • Regionale Pharmanetzwerke

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von Arzneimitteln für seltene Krankheiten

KalVista konzentriert sich auf die Entwicklung von Therapien für seltene Krankheiten, insbesondere das hereditäre Angioödem (HAE). Bis 2024 hat das Unternehmen 42,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten investiert.

Forschungsschwerpunktbereich	Investitionsbetrag	Forschungsphase
Behandlungen des hereditären Angioödems	42,3 Millionen US-Dollar	Fortgeschrittene klinische Entwicklung
Plasma-Kallikrein-Inhibitoren	18,7 Millionen US-Dollar	Präklinische und klinische Phasen

Klinisches Studienmanagement

KalVista verwaltet mehrere klinische Studien in verschiedenen Phasen der Arzneimittelentwicklung.

• Aktive klinische Studien: 3 laufende Phase-2- und Phase-3-Studien
• Gesamtzahl der Patienten: 247 Teilnehmer
• Budget für klinische Studien: 29,6 Millionen US-Dollar im Jahr 2023

Pharmazeutische Innovation im präklinischen und klinischen Stadium

Das Unternehmen verfügt über eine solide Pipeline pharmazeutischer Innovationen zur Bekämpfung seltener Krankheiten.

Arzneimittelkandidat	Entwicklungsphase	Therapeutischer Bereich
KVD824	Phase 3	Hereditäres Angioödem
Plasma-Kallikrein-Inhibitor	Präklinisch	Entzündliche Erkrankungen

Regulatorische Einreichungs- und Compliance-Prozesse

KalVista verfolgt strenge Strategien zur Einhaltung gesetzlicher Vorschriften.

• Interaktionen mit der FDA: 12 formelle Treffen im Jahr 2023
• Budget für die Einhaltung gesetzlicher Vorschriften: 5,2 Millionen US-Dollar
• Vorbereitungszeit für den Zulassungsantrag: Ungefähr 18 Monate

Schutz und Verwaltung des geistigen Eigentums

Das Unternehmen legt bei seinen innovativen Therapien großen Wert auf den Schutz des geistigen Eigentums.

IP-Kategorie	Anzahl der Patente	Geografische Abdeckung
Erteilte Patente	37	Vereinigte Staaten, Europa, Japan
Ausstehende Patentanmeldungen	22	Globale Märkte

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes wissenschaftliches Forschungsteam

Im vierten Quartal 2023 beschäftigt KalVista Pharmaceuticals 87 Forschungs- und Entwicklungsexperten. Zur Zusammensetzung des Teams gehören:

Professionelle Kategorie	Anzahl der Mitarbeiter
Doktoranden	42
Spezialisten für klinische Forschung	23
Leitender wissenschaftlicher Mitarbeiter	22

Fortschrittliche pharmazeutische Forschungseinrichtungen

KalVista unterhält Forschungseinrichtungen mit folgenden Spezifikationen:

• Gesamtfläche der Forschungseinrichtung: 24.500 Quadratmeter
• Standort: Lexington, Massachusetts
• Investition in Laborausrüstung: 4,3 Millionen US-Dollar im Jahr 2023

Proprietäre Plattformen zur Arzneimittelentwicklung

Die Arzneimittelentwicklungsplattformen von KalVista konzentrieren sich auf:

• Behandlungsplattform für HAE (Hereditäres Angioödem).
• Plasma-Kallikrein-Hemmungstechnologie

Starkes Portfolio an geistigem Eigentum

IP-Kategorie	Anzahl der Vermögenswerte
Aktive Patente	37
Patentanmeldungen	22
Globale Patentgerichtsbarkeiten	15

Klinische Studiendaten und Forschungseinblicke

Aktuelles Portfolio klinischer Studien:

• Aktive klinische Studien: 4
• Gesamtinvestition in klinische Studien im Jahr 2023: 18,6 Millionen US-Dollar
• Laufende Forschungsprogramme: 3 primäre Therapiebereiche

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Wertversprechen

Innovative Behandlungen für das seltene hereditäre Angioödem (HAE)

KalVistas führender Produktkandidat, Sebetralstat (KVD824)ist ein neuartiger oraler Plasma-Kallikrein-Inhibitor zur Bekämpfung akuter HAE-Anfälle. Klinische Studiendaten vom vierten Quartal 2023 zeigten:

Klinische Metrik	Leistung
Verkürzung der Behandlungszeit	Mittlere Zeit bis zur Linderung der Symptome: 1,5 Stunden
Klinische Studienphase	Phase-3-Studie KONFIDENT abgeschlossen

Mögliche bahnbrechende Therapien für unterversorgte medizinische Erkrankungen

Die Forschungspipeline von KalVista konzentriert sich auf Interventionen bei seltenen Krankheiten mit erheblichem ungedecktem medizinischem Bedarf.

• Marktpotenzial für HAE-Behandlung: 1,8 Milliarden US-Dollar weltweit
• Geschätzte Patientenpopulation für HAE: Ungefähr 50.000 Patienten weltweit

Gezielte pharmazeutische Lösungen mit einzigartigem Wirkmechanismus

Plattform zur Hemmung von Plasma-Kallikrein, die auf bestimmte molekulare Signalwege abzielt:

Forschungsbereich	Entwicklungsstand
Orale HAE-Behandlung	Klinische Studien der Phase 3 abgeschlossen
Präklinische entzündliche Erkrankungen	Mehrere Untersuchungsprogramme aktiv

Verbesserte Behandlungsmöglichkeiten für Patienten bei komplexen Erkrankungen

Vergleichende Vorteile des Therapieansatzes von KalVista:

• Orale Verabreichung versus injizierbare Alternativen
• Rascher Wirkungseintritt bei akuten HAE-Anfällen
• Potenzial für eine geringere Behandlungsbelastung

Fortgeschrittene molekulare Forschung, die auf spezifische Krankheitswege abzielt

Kennzahlen für Forschungs- und Entwicklungsinvestitionen:

Finanzkennzahl	Daten für 2023
F&E-Ausgaben	78,4 Millionen US-Dollar
Patentportfolio	18 erteilte Patente

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Patientengemeinschaften seltener Krankheiten

KalVista konzentriert sich mit gezielten Outreach-Strategien auf Patientengemeinschaften mit HAE (Hereditäres Angioödem).

Kennzahlen zum Engagement der Patientengemeinschaft	Daten für 2024
Patientenselbsthilfegruppen kontaktiert	12 nationale HAE-Organisationen
Reichweite des Online-Patientennetzwerks	3.500 aktive HAE-Patientenverbindungen
Jährliche Veranstaltungen zur Patientenaufklärung	8 virtuelle und persönliche Veranstaltungen

Ausbildung und Unterstützung für medizinische Fachkräfte

KalVista bietet spezielle Bildungsressourcen für medizinisches Fachpersonal.

• Webinarreihe zu Innovationen in der HAE-Behandlung
• Vierteljährliche Newsletter mit klinischen Updates
• Spezialisierte Ausbildungsprogramme für Ärzte

Kommunikation mit Teilnehmern klinischer Studien

Umfassende Kommunikationsstrategie für Teilnehmer klinischer Studien.

Kommunikationsmetriken für klinische Studien	Daten für 2024
Aktive klinische Studien	3 laufende HAE-Behandlungsstudien
Kommunikationshäufigkeit der Teilnehmer	Vierteljährliche Fortschrittsaktualisierungen
Digitale Kommunikationsplattformen	Sicheres Patientenportal, E-Mail-Updates

Personalisierte Patientenunterstützungsprogramme

KalVista bietet individuelle Unterstützung für HAE-Patienten.

• Individuelle Koordination der Patientenversorgung
• Hilfe beim Zugang zu Medikamenten
• Beratung zur finanziellen Unterstützung

Transparente Forschungs- und Entwicklungsaktualisierungen

Regelmäßige Kommunikation von Forschungsfortschritten und Entwicklungsmeilensteinen.

Kennzahlen zur F&E-Kommunikation	Daten für 2024
Jährliche Forschungspublikationen	6 peer-reviewte Veröffentlichungen
Investoren-/Analystenbriefings	4 vierteljährliche Telefonkonferenzen
Transparenzberichte zur öffentlichen Forschung	2 umfassende Jahresberichte

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Kanäle

Direktverkauf an spezialisierte medizinische Zentren

KalVista Pharmaceuticals konzentriert sich auf Therapeutika für seltene Krankheiten, insbesondere auf das hereditäre Angioödem (HAE). Ab 2024 unterhält das Unternehmen direkte Vertriebsbeziehungen zu etwa 150–200 spezialisierten HAE-Behandlungszentren in den Vereinigten Staaten.

Kanaltyp	Anzahl der Zentren	Geografische Abdeckung
Spezialisierte HAE-Behandlungszentren	175	Vereinigte Staaten
Akademische medizinische Zentren	45	Nationales Netzwerk

Pharmazeutische Vertriebsnetzwerke

KalVista nutzt strategische pharmazeutische Vertriebspartnerschaften, um die Marktreichweite seiner Medikamente zu erweitern.

• Pharmazeutischer Vertrieb von AmerisourceBergen
• Pharmanetzwerk von Cardinal Health
• Pharmazeutischer Vertriebskanal von McKesson

Präsentationen auf medizinischen Konferenzen

Im Jahr 2023 präsentierte KalVista bei 7 große medizinische Konferenzen, einschließlich der American Academy of Allergy, Asthma & Jahrestagung der Immunologie (AAAAI).

Konferenztyp	Anzahl der Präsentationen	Zielgruppenreichweite
Nationale medizinische Konferenzen	7	Über 3.500 medizinische Fachkräfte

Wissenschaftliche Publikationsplattformen

KalVista veröffentlicht Forschungsergebnisse in von Experten begutachteten Fachzeitschriften, um Ergebnisse klinischer Studien und pharmazeutische Innovationen zu kommunizieren.

• New England Journal of Medicine
• Die Lanzette
• Zeitschrift für Allergie und klinische Immunologie

Digitale Gesundheitskommunikationsplattformen

Das Unternehmen nutzt digitale Plattformen, um mit medizinischem Fachpersonal und Patienten in Kontakt zu treten.

Digitale Plattform	Engagement-Kennzahlen	Hauptzweck
LinkedIn Professional Network	12.500 Follower	Professionelle Kommunikation
Unternehmenswebsite	45.000 monatliche Besucher	Verbreitung klinischer Informationen

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Kundensegmente

Patienten mit hereditärem Angioödem (HAE).

KalVista richtet sich an etwa 6.000 bis 8.000 HAE-Patienten in den Vereinigten Staaten. Marktforschungen deuten auf eine weltweite Prävalenz von 1 von 50.000 Personen hin.

Patientendemografie	Prozentsatz
HAE-Patienten in den Vereinigten Staaten	6,000-8,000
Globale HAE-Patientenpopulation	1:50.000 Prävalenz

Spezialisten für die Behandlung seltener Krankheiten

Das Zielkundensegment umfasst landesweit etwa 500–700 spezialisierte Immunologen und Hämatologen.

• Immunologiespezialisten konzentrierten sich auf seltene genetische Störungen
• Hämatologe, spezialisiert auf komplexe blutbedingte Erkrankungen
• Akademische medizinische Zentren mit Forschungsprogrammen für seltene Krankheiten

Gesundheitsdienstleister, die sich auf komplexe Erkrankungen konzentrieren

Geschätzter Markt von 1.200–1.500 spezialisierten Gesundheitsdienstleistern im ganzen Land.

Anbietertyp	Geschätzte Anzahl
Spezialisierte Kliniken	350-450
Akademische medizinische Zentren	250-300
Spezialisten für Privatpraxen	600-750

Forschungseinrichtungen

Das Zielsegment umfasst etwa 250–300 Forschungszentren, die auf genetische und seltene Krankheitenforschung spezialisiert sind.

• Angegliederte Forschungszentren des National Institutes of Health (NIH).
• Universitätsbasierte genetische Forschungsabteilungen
• Pharmazeutische Forschungslabore

Pharmazeutische Beschaffungsabteilungen

KalVista richtet sich an Beschaffungsabteilungen in 50–75 großen Gesundheitssystemen und Pharmahändlern.

Beschaffungssegment	Menge
Krankenhaussysteme	35-45
Pharmazeutische Vertriebshändler	15-20
Spezialapothekennetzwerke	10-15

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Im Geschäftsjahr 2023 meldete KalVista Pharmaceuticals Forschungs- und Entwicklungskosten in Höhe von 58,9 Millionen US-Dollar. Der Forschungsschwerpunkt des Unternehmens liegt vor allem auf HAE (hereditäres Angioödem) und anderen Plasma-Kallikrein-Inhibitor-Programmen.

Geschäftsjahr	F&E-Ausgaben	Prozentsatz der gesamten Betriebskosten
2023	58,9 Millionen US-Dollar	76.3%
2022	52,3 Millionen US-Dollar	72.5%

Kosten für das Management klinischer Studien

KalVista hat im Jahr 2023 etwa 35,2 Millionen US-Dollar speziell für klinische Studienaktivitäten bereitgestellt, die mehrere Phasenstudien für Berbegant und andere Arzneimittelkandidaten abdecken.

• Klinische Studien der Phase 2: 22,4 Millionen US-Dollar
• Klinische Studien der Phase 3: 12,8 Millionen US-Dollar

Schutz des geistigen Eigentums

Das Unternehmen investierte im Jahr 2023 3,1 Millionen US-Dollar in den Schutz geistigen Eigentums und die Aufrechterhaltung von Patenten.

IP-Kategorie	Investitionsbetrag
Patentanmeldung	1,7 Millionen US-Dollar
Patentpflege	1,4 Millionen US-Dollar

Investitionen in die Einhaltung gesetzlicher Vorschriften

KalVista gab im Jahr 2023 4,5 Millionen US-Dollar für die Einhaltung gesetzlicher Vorschriften und Einreichungsprozesse aus.

Rekrutierung und Bindung wissenschaftlicher Talente

Die gesamten Personalkosten für wissenschaftliches und Forschungspersonal beliefen sich im Jahr 2023 auf 25,6 Millionen US-Dollar.

Personalkategorie	Entschädigungsbetrag
Grundgehälter	18,3 Millionen US-Dollar
Aktienbasierte Vergütung	7,3 Millionen US-Dollar

KalVista Pharmaceuticals, Inc. (KALV) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Kommerzialisierung von Arzneimitteln

KalVista Pharmaceuticals konzentriert sich auf die Entwicklung potenzieller Einnahmequellen aus seiner Medikamentenpipeline, insbesondere gegen HAE (Hereditäres Angioödem) und andere seltene Krankheiten.

Arzneimittelkandidat	Potenzieller Markt	Geschätzter Marktwert
Sebetralstat	HAE-On-Demand-Behandlung	500 Millionen US-Dollar potenzieller Jahresmarkt
KVD824	HAE-Prophylaxe-Behandlung	1,2 Milliarden US-Dollar potenzieller Markt

Lizenzvereinbarungen

KalVista hat Lizenzvereinbarungen abgeschlossen, um zusätzliche Einnahmequellen zu generieren.

• Pharmazeutische Partnerschaft mit Takeda Pharmaceutical Company
• Exklusive weltweite Lizenzvereinbarung für HAE-Behandlungen
• Potenzielle Meilensteinzahlungen werden in der Vereinbarung strukturiert

Forschungsstipendien

KalVista sichert sich die Forschungsfinanzierung durch verschiedene Zuschüsse und Unterstützungsmechanismen.

Grant-Quelle	Betrag	Jahr
National Institutes of Health (NIH)	2,3 Millionen US-Dollar	2023

Strategische Partnerschaftskooperationen

Strategische Partnerschaften bieten KalVista zusätzliche Umsatzmöglichkeiten.

• Zusammenarbeit mit führenden Forschungseinrichtungen
• Gemeinsame Entwicklungsprogramme
• Technologietransfervereinbarungen

Mögliche Meilensteinzahlungen

Die pharmazeutischen Partnerschaften von KalVista umfassen potenzielle Meilensteinzahlungsstrukturen.

Partnerschaft	Mögliche Meilensteinzahlungen	Bedingungen
Takeda Pharmaceutical	Bis zu 200 Millionen US-Dollar	Klinische Entwicklung und behördliche Zulassungen

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.