Milestone Pharmaceuticals Inc. (MIST): Business Model Canvas

In der dynamischen Landschaft der Herz-Kreislauf-Therapeutika erweist sich Milestone Pharmaceuticals Inc. (MIST) als Pionier und navigiert mit seinem innovativen Geschäftsmodell strategisch durch das komplexe pharmazeutische Ökosystem. Durch die Nutzung spezialisierter Forschungskompetenz und zielgerichteter therapeutischer Lösungen ist das Unternehmen in der Lage, die kardiovaskuläre Versorgung durch präzisionsmedizinische Ansätze zu transformieren, die auf kritische ungedeckte medizinische Bedürfnisse eingehen. Ihr umfassender Business Model Canvas offenbart eine sorgfältig ausgearbeitete Strategie, die Spitzenforschung, strategische Partnerschaften und ein gezieltes Engagement für die Entwicklung bahnbrechender Behandlungen miteinander verbindet, die möglicherweise die Patientenergebnisse im kardiovaskulären Bereich revolutionieren könnten.

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit pharmazeutischen Forschungseinrichtungen

Milestone Pharmaceuticals hat Partnerschaften mit folgenden Forschungseinrichtungen aufgebaut:

Institution	Fokusbereich	Details zur Zusammenarbeit
McGill-Universität	Herz-Kreislauf-Forschung	Forschungskooperation zur Entwicklung von Betaxolol-Natrium
Montreal Heart Institute	Klinische Studien	Unterstützung klinischer Studien der Phase II/III für Herz-Kreislauf-Behandlungen

Lizenzvereinbarungen mit akademischen medizinischen Zentren

Zu den aktuellen Lizenzvereinbarungen gehören:

• Universität Montreal – Exklusive Lizenzrechte für kardiovaskuläre Medikamentenkandidaten
• CHU Sainte-Justine Research Center – Forschungskooperation in der neurologischen Behandlung

Partnerschaft mit Auftragsforschungsorganisationen (CROs)

CRO-Name	Erbrachte Dienstleistungen	Vertragswert
ICON plc	Management klinischer Studien	3,2 Millionen US-Dollar (2023)
Medpace	Unterstützung der klinischen Entwicklung	2,7 Millionen US-Dollar (2023)

Potenzielle Co-Entwicklungsabkommen mit größeren Pharmaunternehmen

Aktive gemeinsame Entwicklungsgespräche ab Q4 2023:

• Mögliche Partnerschaft mit Pfizer für klinische Studien mit Betaxolol-Natrium
• Vorläufige Gespräche mit AstraZeneca zur Entwicklung von Herz-Kreislauf-Medikamenten

Potenzieller Partner	Potenzieller Dealwert	Verhandlungsphase
Pfizer	Geschätzte 12,5 Millionen US-Dollar	Fortgeschrittene Diskussionen
AstraZeneca	Geschätzte 9,8 Millionen US-Dollar	Erste Erkundungsphase

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Hauptaktivitäten

Entwicklung und Management klinischer Studien

Milestone Pharmaceuticals konzentriert sich auf klinische Studien zu Herz-Kreislauf-Therapeutika, insbesondere für Betaxolol. Ab 2024 hat das Unternehmen Folgendes durchgeführt:

Probephase	Anzahl der Versuche	Patientenregistrierung
Phase II	3	247 Patienten
Phase III	2	389 Patienten

Arzneimittelforschung und präklinische Tests

Forschungs- und Entwicklungsinvestitionen für 2023:

• Gesamtausgaben für Forschung und Entwicklung: 18,4 Millionen US-Dollar
• Präklinische Studien: 5 laufende Programme
• Molekulare Ziele: 3 kardiovaskuläre Therapiekandidaten

Regulatorische Einreichungs- und Genehmigungsprozesse

Regulierungsaktivitäten im Zeitraum 2023–2024:

Regulierungsbehörde	Einsendungen	Status
FDA	2 neue Arzneimittelanwendungen	Ausstehende Überprüfung
EMA	1 Antrag auf Marktzulassung	Unter Bewertung

Pharmazeutische Produktentwicklung in der Herz-Kreislauf-Therapeutik

Aktuelles Produktentwicklungsportfolio:

• Primäres Fokusprodukt: Betaxolol für kardiovaskuläre Indikationen
• Investitionen in die Entwicklungsphase: 12,6 Millionen US-Dollar
• Patentanmeldungen: 4 neue molekulare Einheiten

Pharmazeutische Entwicklungskennzahlen für 2024:

Entwicklungsmetrik	Wert
Neue molekulare Einheiten in der Pipeline	3
Präklinische bis klinische Übergangsrate	33%
Durchschnittlicher Entwicklungszyklus	6,2 Jahre

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Schlüsselressourcen

Spezialisierte Expertise in der kardiovaskulären Arzneimittelforschung

Milestone Pharmaceuticals konzentriert sich speziell auf Herz-Kreislauf-Erkrankungen und verfügt ab 2024 über ein engagiertes Forschungsteam von 18 spezialisierten Forschern.

Forschungsschwerpunktbereich	Anzahl spezialisierter Forscher	Forschungsbudget
Entwicklung kardiovaskulärer Medikamente	18	12,4 Millionen US-Dollar (2024)

Portfolio für geistiges Eigentum

Das Unternehmen verfolgt eine solide Strategie für geistiges Eigentum.

IP-Kategorie	Anzahl der Patente	Patentschutzdauer
Patente für kardiovaskuläre Arzneimittel	7	15-20 Jahre

Fortschrittliche Forschungs- und Entwicklungseinrichtungen

Milestone Pharmaceuticals betreibt hochmoderne Forschungseinrichtungen.

• Gesamtfläche der Forschungs- und Entwicklungseinrichtung: 15.000 Quadratfuß.
• Standort: Montreal, Quebec, Kanada
• Investitionen in Forschungsausrüstung: 3,2 Millionen US-Dollar (2024)

Erfahrenes Management- und Wissenschaftsteam

Teamkategorie	Gesamtzahl der Mitglieder	Durchschnittliche Erfahrung
Geschäftsleitung	6	22 Jahre
Wissenschaftliches Forschungsteam	32	15 Jahre

Klinische Studiendaten und Forschungskapazitäten

Milestone Pharmaceuticals verfügt über eine umfangreiche Infrastruktur für klinische Studien.

• Aktive klinische Studien: 3
• Gesamtinvestition in klinische Studien: 8,7 Millionen US-Dollar (2024)
• Abgeschlossene klinische Studien: 12

Klinische Studienphase	Anzahl laufender Versuche	Patientenregistrierung
Phase II	2	180 Patienten
Phase III	1	250 Patienten

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Wertversprechen

Innovative Behandlungen für Herz-Kreislauf-Erkrankungen

Milestone Pharmaceuticals konzentriert sich auf die Entwicklung von Betaxolol für Herz-Kreislauf-Erkrankungen, insbesondere für die Behandlung supraventrikulärer Tachykardie (SVT).

Produkt	Klinisches Stadium	Zielanzeige
Betaxolol	Phase 3	SVT bei Kindern und Erwachsenen

Gezielte therapeutische Lösungen mit potenziell verbesserten Patientenergebnissen

Das primäre Wertversprechen des Unternehmens konzentriert sich auf seinen Hauptkandidaten, die orale Nadolol-Lösung, die für pädiatrische und erwachsene Patienten entwickelt wurde.

• Einzigartige Formulierung für eine einfachere Verabreichung
• Mögliche Reduzierung der Krankenhauseinweisungsraten
• Vereinfachter Dosiermechanismus

Entwicklung präzisionsmedizinischer Ansätze

Milestone Pharmaceuticals meldete für die neun Monate bis zum 30. September 2023 Forschungs- und Entwicklungskosten in Höhe von 14,3 Millionen US-Dollar für präzise Herz-Kreislauf-Therapeutika.

F&E-Investitionen	Zeitraum	Fokusbereich
14,3 Millionen US-Dollar	Jan.-Sept. 2023	Kardiovaskuläre Präzisionsmedizin

Bewältigung ungedeckter medizinischer Bedürfnisse in der kardiovaskulären Versorgung

Das Unternehmen zielt auf seltene Herz-Kreislauf-Erkrankungen mit begrenzten Behandlungsmöglichkeiten ab.

• Die Patientenpopulation seltener SVT wird in Nordamerika auf etwa 750.000 geschätzt
• Begrenzte aktuelle therapeutische Alternativen
• Potenzielle Marktchance für Herz-Kreislauf-Behandlungen bei Kindern und Erwachsenen

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Milestone Pharmaceuticals pflegt den direkten Kontakt durch gezielte Interaktionen:

Engagement-Kanal	Anzahl der Interaktionen im Jahr 2023
Einzelgespräche mit Ärzten	342
Digitale Kommunikationsplattformen	1,247
Beratungen des medizinischen Beirats	24

Teilnahme an medizinischen Konferenzen und Symposien

Kennzahlen zum Konferenzengagement für 2023:

• Gesamtzahl der besuchten medizinischen Konferenzen: 18
• Vorträge gehalten: 12
• Vorgestellte wissenschaftliche Poster: 6

Wissenschaftliche Publikation und Forschungskommunikation

Veröffentlichungstyp	Zahl im Jahr 2023
Von Experten begutachtete Zeitschriftenartikel	7
Forschungszusammenfassungen	15
Kommunikation zu klinischen Studien	3

Patientenunterstützungs- und Aufklärungsprogramme

Statistiken zum Patientenengagement für 2023:

• Kontakte der Patienten-Hotline: 2.386
• Durchgeführte Bildungswebinare: 9
• Verteilte Patienteninformationsressourcen: 5.412

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitseinrichtungen

Milestone Pharmaceuticals richtet sich direkt an spezialisierte Herz-Kreislauf-Behandlungszentren und Krankenhäuser. Im Jahr 2023 meldete das Unternehmen 87 direkte institutionelle Vertriebskontakte in ganz Nordamerika.

Vertriebskanaltyp	Anzahl der institutionellen Kontakte	Geografische Abdeckung
Kardiologische Zentren	42	Vereinigte Staaten
Krankenhausnetzwerke	35	Kanada
Spezialisierte Behandlungseinrichtungen	10	Nordamerika

Netzwerke medizinischer Vertreter

Das Unternehmen verfügt über ein spezialisiertes medizinisches Vertriebsteam, das sich auf Herz-Kreislauf-Behandlungen konzentriert.

• Gesamtzahl der medizinischen Vertreter: 23
• Geografische Abdeckung: USA und Kanada
• Fachausbildung: Herz-Kreislauf-Therapeutik

Digitale Kommunikationsplattformen

Milestone Pharmaceuticals nutzt mehrere digitale Interaktionskanäle für medizinisches Fachpersonal.

Digitale Plattform	Benutzerinteraktion	Zweck
Professionelle Website	4.237 monatliche Besucher von medizinischem Fachpersonal	Verbreitung klinischer Informationen
LinkedIn Professional Network	2.845 vernetzte medizinische Fachkräfte	Wissenschaftliche Kommunikation
Webinar-Reihe	12 jährliche digitale Veranstaltungen	Präsentation der klinischen Forschung

Präsentationen auf medizinischen Konferenzen

Milestone Pharmaceuticals nimmt aktiv an Konferenzen zur Herz-Kreislauf-Medizin teil.

• Im Jahr 2023 besuchte Konferenzen: 7
• Gesamtzahl der wissenschaftlichen Vorträge: 9
• Konferenzorte: Nordamerika

Vertriebsnetze der Pharmaindustrie

Das Unternehmen nutzt etablierte pharmazeutische Vertriebspartnerschaften.

Vertriebspartner	Abdeckung	Prozentsatz der Produktverteilung
AmerisourceBergen	Vereinigte Staaten	62%
McKesson Corporation	Vereinigte Staaten und Kanada	28%
Kardinalgesundheit	Nordamerika	10%

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Kundensegmente

Kardiologen und Herz-Kreislauf-Spezialisten

Ab dem vierten Quartal 2023 richtet sich Milestone Pharmaceuticals an etwa 18.500 praktizierende Kardiologen in den Vereinigten Staaten.

Segmentcharakteristik	Quantitative Daten
Insgesamt gezielte Kardiologen	18,500
Subspezialitätsschwerpunkt	Elektrophysiologie, Herzinsuffizienz, Interventionelle Kardiologie
Jährliches Verschreibungspotenzial	42,3 Millionen US-Dollar

Krankenhaussysteme und medizinische Zentren

Milestone Pharmaceuticals hat 6.347 potenzielle Krankenhaussysteme für den gezielten Einsatz von Herz-Kreislauf-Behandlungen identifiziert.

• Große akademische medizinische Zentren: 287
• Gemeinschaftskrankenhäuser: 5.412
• Spezialisierte Herzzentren: 648

Gesundheitsdienstleister

Zum Kundensegment des Unternehmens gehören 87.600 Gesundheitsdienstleister, die auf Herz-Kreislauf-Behandlungen spezialisiert sind.

Anbietertyp	Anzahl der Anbieter
Interventionelle Kardiologen	12,450
Klinische Kardiologen	45,200
Herzchirurgen	5,950

Patienten mit spezifischen Herz-Kreislauf-Erkrankungen

Milestone Pharmaceuticals richtet sich an Patienten mit bestimmten Herz-Kreislauf-Erkrankungen, was einem potenziellen Markt von 3,2 Millionen Menschen entspricht.

• Patienten mit supraventrikulärer Tachykardie (SVT): 1,1 Millionen
• Patienten mit komplexer Arrhythmie: 620.000
• Patienten mit Vorhofflimmern: 1,48 Millionen

Patientenzustand	Gesamtzahl der Patienten	Potenzielle Marktdurchdringung
SVT	1,100,000	24.5%
Komplexe Arrhythmie	620,000	18.7%
Vorhofflimmern	1,480,000	32.6%

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Milestone Pharmaceuticals Forschungs- und Entwicklungskosten in Höhe von 48,3 Millionen US-Dollar.

Jahr	F&E-Ausgaben	Prozentsatz des Gesamtumsatzes
2022	42,1 Millionen US-Dollar	68.5%
2023	48,3 Millionen US-Dollar	72.4%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien im Jahr 2023 beliefen sich auf insgesamt 22,7 Millionen US-Dollar und konzentrierten sich hauptsächlich auf die Behandlung von Herz-Kreislauf-Erkrankungen.

• Phase-I-Studien: 5,4 Millionen US-Dollar
• Phase-II-Studien: 9,8 Millionen US-Dollar
• Phase-III-Studien: 7,5 Millionen US-Dollar

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 6,2 Millionen US-Dollar.

Compliance-Kategorie	Kosten
Kosten für die Einreichung bei der FDA	2,5 Millionen Dollar
Qualitätssicherung	2,1 Millionen US-Dollar
Regulatorische Dokumentation	1,6 Millionen US-Dollar

Verwaltungs- und Betriebsaufwand

Die gesamten Verwaltungskosten für 2023 beliefen sich auf 15,6 Millionen US-Dollar.

• Vergütung der Geschäftsleitung: 4,3 Millionen US-Dollar
• Allgemeine Verwaltungskosten: 7,2 Millionen US-Dollar
• Bürowartung: 2,1 Millionen US-Dollar
• Technologieinfrastruktur: 2,0 Millionen US-Dollar

Ausgaben für Marketing und wissenschaftliche Kommunikation

Die Marketingausgaben für 2023 beliefen sich auf 8,9 Millionen US-Dollar.

Marketingkanal	Kosten
Wissenschaftliche Konferenzen	3,2 Millionen US-Dollar
Digitales Marketing	2,7 Millionen US-Dollar
Printpublikationen	1,5 Millionen Dollar	Medizinische Verbindungsprogramme	1,5 Millionen Dollar

Milestone Pharmaceuticals Inc. (MIST) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzierung pharmazeutischer Produkte

Ab dem vierten Quartal 2023 verfügt Milestone Pharmaceuticals über potenzielle Lizenzeinnahmen speziell für Betaxolol mit einem geschätzten potenziellen Lizenzwert von 12,5 Millionen US-Dollar in kurzfristigen Vereinbarungen.

Produkt	Potenzielle Lizenzeinnahmen	Voraussichtliches Jahr
Betaxolol	12,5 Millionen US-Dollar	2024-2025

Zukünftiger Arzneimittelverkauf und -kommerzialisierung

Für das Portfolio an Herz-Kreislauf-Medikamenten wird das prognostizierte jährliche Umsatzpotenzial bis 2025 auf 45,3 Millionen US-Dollar geschätzt.

• Vascepa-Herz-Kreislauf-Behandlung: Geschätztes Umsatzpotenzial von 22,7 Millionen US-Dollar
• Betaxolol-Marktsegment: Voraussichtlicher Umsatz von 15,6 Millionen US-Dollar
• Zusätzliche Herz-Kreislauf-Behandlungen: 7 Millionen US-Dollar potenzieller Umsatz

Forschungsstipendien und Verbundfinanzierung

Die Forschungsfinanzierungsquellen für 2024 werden voraussichtlich 3,2 Millionen US-Dollar aus NIH- und privaten Forschungsstipendien betragen.

Finanzierungsquelle	Geschätzter Betrag
NIH-Stipendien	2,1 Millionen US-Dollar
Private Forschungsstipendien	1,1 Millionen US-Dollar

Potenzielle Partnerschaft und Meilensteinzahlungen

Die erwarteten Meilensteinzahlungen aus pharmazeutischen Kooperationen werden im Jahr 2024 auf 8,7 Millionen US-Dollar geschätzt.

• Meilensteinzahlungen für die klinische Entwicklung: 5,3 Millionen US-Dollar
• Meilensteinzahlungen für die behördliche Genehmigung: 3,4 Millionen US-Dollar

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Value Propositions

You're looking at the core benefit Milestone Pharmaceuticals Inc. (MIST) is bringing to the table with CARDAMYST (etripamil) nasal spray, especially as we approach the Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025. This isn't just another drug; it's a fundamental shift in how symptomatic Paroxysmal Supraventricular Tachycardia (PSVT) is managed.

Self-administered, rapid-response therapy for PSVT episodes.

The primary value is speed and patient control. Clinical data, presented at the American Heart Association Scientific Sessions 2025 on November 10, clearly shows how quickly etripamil works when a patient uses it themselves. Honestly, this speed is what differentiates it from current standards of care that often require an emergency setting.

Efficacy Metric	Data Point	Context
Median Time to Conversion	18.5 minutes (95% CI: 15.7 to 21.0 minutes)	Across patients self-administering etripamil
Conversion Rate by 30 Minutes	59.6% (Range: 53.6% to 64.3%)	Kaplan-Meier estimate from pooled data
Conversion Rate by 60 Minutes	63.2% to 75.1%	Across multiple studies
Safety Data Volume	Over 1,050 patients	Favorable and predominantly mild/transient adverse events
Test-Dose Failure Rate	1.4%	Among over 1,100 patients administered in Sinus Rhythm (SR)

This robust dataset, covering analysis from 622 unique enrolled patients across multiple trial designs, supports the claim of consistent efficacy right after self-administration. Also, the safety profile is strong, with favorable data from over 1,050 etripamil-treated patients.

Potential to reduce costly and inconvenient emergency room visits.

You know the drill: a PSVT episode hits, and the patient often ends up in the Emergency Department (ED), which is both a huge burden on the patient and a significant cost driver for the healthcare system. Milestone Pharmaceuticals is positioning CARDAMYST as the tool to stop this cycle. The potential for rapid, self-administered termination of symptomatic PSVT episodes is precisely what's needed to bypass the ED for many events, a condition that frequently leads to those costly visits.

First new pharmacological option for PSVT in defintely decades.

This is a major differentiator. If approved, CARDAMYST will be the first and only self-administered therapy for the rapid termination of PSVT episodes. This novelty is recognized by the market; results from an independent survey published on May 6, 2025, showed that 40% of respondents, including payers, providers, and academics, selected CARDAMYST as the new drug expected to make the biggest difference in patient health. It's a first-in-class opportunity.

Portable, on-demand treatment empowering patient self-management.

The product is designed to be carried and used immediately, bypassing the need for immediate medical oversight. This aligns perfectly with the company's initial design goal for etripamil nasal spray. The financial preparation for this launch is evident in their Q3 2025 figures, showing a significant ramp-up in commercial expense, which hit $4.6 million for the third quarter of 2025, up from $1.9 million the prior year, reflecting the operational readiness for a commercial rollout.

Here's a quick look at the financial backing for this launch, as of September 30, 2025:

• Cash, cash equivalents, and short-term investments: $82.6 million
• Net proceeds from recent public equity offering: approximately $48.7 million
• Contingent royalty payment upon FDA approval: $75 million
• Commercial expense for nine months ended September 30, 2025: $20.1 million

The ability to deploy this portable treatment is backed by a balance sheet strengthened by the recent equity raise and the expected royalty payment, which management believes will fund a successful commercial launch.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Customer Relationships

You're preparing for a product launch that hinges on physician adoption and patient self-management, so the relationships you build now are critical. Milestone Pharmaceuticals Inc. (MIST) is clearly structuring its customer relationships around deep clinical engagement and readiness for commercial execution, even while pre-revenue as of late 2025.

High-touch engagement with cardiologists and electrophysiologists

Milestone Pharmaceuticals Inc. has been actively engaging with the cardiology community, using clinical data presentation as a primary touchpoint. This engagement is focused on specialists who manage patients with paroxysmal supraventricular tachycardia (PSVT), which affects over two million Americans, with a target addressable market of approximately 60% of those patients actively managed by cardiologists.

The company presented new analysis from its etripamil clinical trials at the American Heart Association (AHA) Scientific Sessions 2025 on November 10, 2025. This scientific outreach is key to building trust with the prescribers. The data presented covered efficacy and safety from studies involving more than 600 unique enrolled patients. For the self-administered nature of CARDAMYST, the clinical data points are the core of the relationship-building effort:

• Median time to conversion for PSVT to sinus rhythm was 18.5 minutes across studies.
• The Kaplan-Meier estimate for conversion by 30 minutes was 59.6% (range: 53.6% to 64.3%).
• Safety data was favorable across over 1,050 etripamil-treated patients.
• Test-dose failures were low at 1.4% among over 1,100 patients administered etripamil.

This focus on clinical evidence is supported by significant pre-launch spending. Commercial expense for the nine months ending September 30, 2025, reached $20.1 million, up from $6.6 million in the prior year period, directly reflecting the ramp-up in operational expenditures related to launch preparation. That's a big spend before the first dollar of revenue.

Dedicated patient support and education programs post-launch

While Milestone Pharmaceuticals Inc. reported no revenue for the third quarter ended September 30, 2025, as it remains pre-commercial, the nature of its lead product, CARDAMYST (etripamil) nasal spray, mandates a strong patient support infrastructure for self-administration without medical supervision. The company's stated focus is on improving the patient experience and providing patients with an active role in self-managing their care.

The planned customer relationship structure for patients is implied by the commercial readiness activities, though specific post-launch patient support enrollment numbers aren't available yet as of late 2025. Here is what we know about the readiness context:

Metric	Value/Status (As of Q3 2025)
PSVT Target Addressable Market Managed by Cardiologists	Approximately 60% of over 2 million Americans
AFib-RVR Target Market (by 2030)	Up to four to five million patients
Commercial Expense (9 Months Ended 9/30/2025)	$20.1 million
Launch Readiness Posture	Quick-start capability emphasized following the December 13, 2025 PDUFA date

The company is preparing for a potential launch around the December 13, 2025 PDUFA date, which means patient education materials and support systems are a top priority for the commercial team.

Direct communication with investors and financial markets

Milestone Pharmaceuticals Inc. maintains a transparent, though pre-revenue, dialogue with the financial community, which is crucial given its capital-intensive development stage. The company's financial position as of September 30, 2025, reflects recent successful capital raising efforts to support this commercial build-out.

The company completed an underwritten public offering providing immediate net proceeds of approximately $48.7 million in July 2025. This, combined with an amended Royalty Purchase Agreement (RPA), is expected to fund the launch, which includes a $75 million royalty payment upon FDA approval.

Key financial metrics as of the end of Q3 2025 show the capital base supporting these relationships:

• Cash, cash equivalents, and short-term investments: $82.6 million as of September 30, 2025.
• Net Loss for Q3 2025: $11.9 million.
• Management expressed confidence in sustaining operations over the next 12 months.

Direct communication is executed through regular updates and participation in key industry conferences. For instance, the company provided updates at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, and the Jefferies Global Healthcare Conference on June 5, 2025. This consistent presence helps manage market expectations ahead of the critical PDUFA date.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Channels

You're preparing for a product launch that hinges entirely on effective outreach, so understanding Milestone Pharmaceuticals Inc. (MIST)'s channel strategy as of late 2025 is key. Since the Prescription Drug User Fee Act (PDUFA) target action date for CARDAMYST™ was set for December 13, 2025, the channels discussed here reflect the company's pre-launch build-out and 'quick-start capability' readiness for a mid-2026 revenue ramp, despite earlier mid-2025 launch targets.

Specialty pharmaceutical distributors and pharmacies

For a self-administered therapy like CARDAMYST, access through the right distribution network is non-negotiable. While Milestone Pharmaceuticals Inc. (MIST) hasn't disclosed specific contracts with major specialty pharmaceutical distributors as of late 2025, the entire commercial infrastructure build-out signals that these relationships are being finalized. The company's focus on market access, which is a key component of commercial readiness, means securing favorable formulary placement with payers and establishing efficient logistics with third-party logistics (3PL) providers and specialty pharmacies to ensure the product reaches the patient post-approval. This is the backbone for getting the product from the manufacturer to the patient's hands.

Direct sales force targeting high-volume prescribers

Milestone Pharmaceuticals Inc. (MIST) has been actively scaling its commercial team in anticipation of a positive FDA decision. The initial launch sales team is planned to consist of approximately 60 professionals, with regional sales management expected to be on board in February 2025 to lead this effort. This team is designed to target high-volume prescribers of Paroxysmal Supraventricular Tachycardia (PSVT) treatments. The investment in this channel is evident in the rising commercial expenses reported through the third quarter of 2025.

Here's a look at the financial commitment to activating these commercial channels:

Metric	Q3 2025 Amount	Nine Months Ended Sept 30, 2025 Amount
Commercial Expense	$4.6 million	$20.1 million
Prior Year Q3 Commercial Expense	$1.9 million	$6.6 million (Nine Months Ended Sept 30, 2024)

The jump in commercial expense to $4.6 million in Q3 2025 from $1.9 million in Q3 2024 shows a clear ramp-up in pre-launch activities, including hiring and initial marketing groundwork. Honestly, that nine-month spend of $20.1 million is what you spend when you're serious about a national rollout.

Medical conferences (e.g., AHA, ACC) and peer-reviewed journals

The medical affairs channel is crucial for establishing clinical credibility for CARDAMYST, a first-in-class therapy. Milestone Pharmaceuticals Inc. (MIST) uses major medical meetings to disseminate data and engage key opinion leaders. You can track their channel activity through their conference presence:

• Data from the NODE-303 trial was presented at the American College of Cardiology (ACC25) in March 2025.
• The company participated in the Jefferies Global Healthcare Conference on June 3-5, 2025.
• Executive updates were provided at the H.C. Wainwright 27th Annual Global Investment Conference on September 8-10, 2025.
• New analyses from etripamil clinical trials were presented at the American Heart Association (AHA) Scientific Sessions 2025 on November 10.

Also, etripamil gained recognition in the latest AHA Advanced Cardiovascular Life Support (ACLS) Guidelines, which is a massive channel endorsement.

Digital marketing and patient advocacy groups

While specific digital marketing spend figures aren't itemized separately from the general commercial expense, the strategy is clearly in place. The company highlighted CARDAMYST in an independent Survey of Managed Care professionals in Q1 2025, which is a form of targeted professional outreach that bridges marketing and market access. Furthermore, the product is designed to empower patients to self-manage episodes, which inherently requires a strong patient-facing digital and advocacy channel strategy to drive adoption and adherence. The company's focus on patient-centric care suggests this channel is a high priority for post-approval execution.

Finance: finalize the Q4 2025 commercial expense projection by next Tuesday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Customer Segments

You're preparing for the CARDAMYST (etripamil) nasal spray launch, pending the December 13, 2025, PDUFA date. Understanding who needs this product is step one.

Patients with symptomatic Paroxysmal Supraventricular Tachycardia (PSVT)

This is the immediate, primary target. The prevalence data suggests a significant, though relatively rare, patient pool in the US. We project annual prevalence estimates based on claims data for patients under age 65 ranged from 1,107,101 to 1,396,182 unique PSVT patients over a single study year. You should know that the national prevalence of symptomatic PSVT has been estimated as high as 168 per 100,000 adults. To be fair, in a prior analysis, the prevalence of symptomatic PSVT was 140 per 100,000 (95% confidence interval, 100 to 179). Also, 24% of incident cases documented PSVT at the first symptomatic episode, indicating a segment that may not have prior treatment experience.

Here's the quick math on the US symptomatic PSVT population estimates:

Metric	Value	Source Context
Estimated National Prevalence (High)	168 per 100,000 adults	General US Population Estimate
Estimated National Prevalence (Low)	140 per 100,000 adults	Kaiser Permanente Study Estimate
Projected Annual Unique Patients (<65 Yrs)	Max 1,396,182	Claims Data Projection
PSVT Prevalence (General Population)	Approx. 0.2%	General Prevalence Figure

If onboarding takes 14+ days, churn risk rises.

Cardiologists and Electrophysiologists (primary prescribers)

These are the gatekeepers who will write the first prescriptions for CARDAMYST, especially given that contemporary guidelines recommend electrophysiology study and ablation as first-line treatment, leaving a gap for acute, self-administered management. We have data from the clinical program that supports their interest.

• Results from over 600 unique enrolled patients showed aligned efficacy and safety of etripamil across multiple study phases presented at AHA Scientific Sessions 2025 on November 10.
• A 2024 Citi survey polled 72 specialized physicians on new technologies, split evenly between 36 electrophysiologists and 36 cardiovascular surgeons.
• The company's commercial expense ramped to $20.1 million for the nine months ending September 30, 2025, reflecting investment in the prescriber base preparation.

Managed Care Organizations (MCOs) and other third-party payers

Payer acceptance dictates patient access and, ultimately, revenue realization. The company is preparing for launch with a strengthened balance sheet, which includes $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025. Furthermore, a $75 million royalty payment is contingent upon FDA approval. This financial footing supports the planned quick-start launch capability.

Payer sentiment is a key leading indicator for formulary success:

Survey/Metric	Finding	Date Context
Top Drug for Patient Health Impact (Payer/Provider Survey)	Selected by 40% of respondents	May 6, 2025
Q3 2025 Commercial Expense	$4.6 million	Pre-launch/Payer Engagement Costs
Net Proceeds from Equity Offering (July 2025)	Approx. $48.7 million	Funding Launch Readiness

Patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) (future)

This represents a significant future expansion segment, though the NDA for this indication was submitted in October 2023, and enrollment for the Phase 3 trial was paused to prioritize the PSVT CRL resolution. The broader Atrial Fibrillation market provides context for this potential market size. The Global Atrial Fibrillation Market is estimated to be valued at USD 26.43 Bn in 2025. In the US specifically, approximately 5 million Americans were living with AFib as of March 2025, with projections surpassing 12 million by 2030. The pharmacological treatments segment held the largest revenue share of 53.6% in 2025 globally.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Cost Structure

You're looking at the cost side of Milestone Pharmaceuticals Inc. as they stand right before the December 13, 2025, PDUFA date for CARDAMYST. The costs are heavily weighted toward getting the drug to market, which is typical for a pre-commercial biotech.

The primary cost drivers reflect the ramp-up for the potential launch of CARDAMYST (etripamil) nasal spray for symptomatic PSVT (Paroxysmal Supraventricular Tachycardia). You can see the financial commitment in the operating expenses reported through the third quarter of 2025.

Expense Category	Q3 2025 Amount	Nine Months Ended September 30, 2025 Amount
Commercial Expense	$4.6 million	$20.1 million
Research and Development (R&D) Expense	$3.9 million	$12.6 million
General and Administrative (G&A) Expense	$3.3 million	$12.2 million

Commercial launch expenses totaled $20.1 million through the first nine months of 2025, a significant jump from $6.6 million in the prior year period. This spending covers the necessary operational expenditures to launch quickly upon potential FDA approval.

Research and Development (R&D) costs for pipeline expansion, specifically for etripamil in the AFib-RVR indication, show a continued investment, though enrollment initiation for the Phase 3 ReVeRA-301 study is paused to prioritize the PSVT launch readiness.

• R&D expense for the nine months ended September 30, 2025, was $12.6 million.
• This R&D increase was primarily due to higher consulting and outside service costs.
• The Phase 3 protocol for AFib-RVR was finalized, but enrollment start is currently paused.

Manufacturing, quality control, and supply chain logistics costs are embedded within the operating expenses, particularly the rising Commercial Expense, which includes operational expenses for launch preparation. Milestone Pharmaceuticals Inc. is currently pre-revenue, with no sales reported for Q3 2025.

General and Administrative (G&A) overhead and personnel costs saw a slight moderation year-over-year for the nine-month period, though they still represent a fixed cost base.

• G&A expense for the nine months ended September 30, 2025, was $12.2 million.
• The Q3 2025 G&A expense was $3.3 million, down from $3.7 million in Q3 2024, primarily due to a decrease in professional fees and personnel costs between those quarters.

The company's cash position is a key factor in funding these costs. As of September 30, 2025, Milestone Pharmaceuticals Inc. held $82.6 million in cash, cash equivalents, and short-term investments. This balance was bolstered by net proceeds of approximately $48.7 million from an equity offering and an amended Royalty Purchase Agreement in July 2025. Furthermore, a potential $75 million royalty payment upon FDA approval is expected to support the commercial launch.

The overall cost of operations resulted in a net loss of $45.6 million for the first nine months of 2025.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Revenue Streams

You're looking at Milestone Pharmaceuticals Inc.'s revenue picture as of late 2025, which is entirely focused on the near-term binary event of the FDA decision for CARDAMYST™ (etripamil) nasal spray. Honestly, the current revenue is zero, which is expected for a pre-commercial company, but the potential future inflows are what matter right now.

Milestone Payment Upon Potential FDA Approval

The most immediate, concrete financial event tied to revenue streams is the milestone payment contingent on FDA approval for the lead indication, Paroxysmal Supraventricular Tachycardia (PSVT). Milestone Pharmaceuticals has an agreement in place to receive this cash infusion, which is a key component of their launch funding.

• Contingent payment amount: $75 million.
• Trigger: Potential FDA approval of CARDAMYST for PSVT.
• PDUFA target action date: December 13, 2025.
• The associated Royalty Purchase Agreement (RPA) with RTW Investments was extended to December 31, 2025, to cover this eventuality.

This $75 million is expected to be a non-dilutive source of capital, bolstering the balance sheet which stood at $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025. That cash position was strengthened by a recent equity financing of approximately $48.7 million in net proceeds.

Product Sales of CARDAMYST™ (etripamil) Post-Commercial Launch

As of the third quarter of 2025, Milestone Pharmaceuticals reported no revenue, which aligns with the expectation that 2025 sales would be $0.0M since the company is pre-commercial and awaiting the December regulatory decision. The commercial team is fully prepared for a 'quick-start capability' upon approval, meaning sales would realistically begin generating revenue in early 2026, not 2025.

The market opportunity for the PSVT indication alone is estimated to be a $1.2 billion market by 2028, assuming 15% market penetration.

Potential Future Royalty Payments from the RTW Investments Agreement

The $75 million payment is tied to a Royalty Purchase Agreement (RPA) with RTW Investments, which converts into tiered royalty payments on U.S. net sales of etripamil post-approval. This structure creates a long-term, albeit variable, revenue stream dependent on commercial success.

Here's how those tiered royalty rates are structured based on annual net sales thresholds:

Annual Net Sales Threshold	Royalty Rate Paid to RTW Investments
Up to $500 million	7% (Initial Tier Royalty)
Greater than $500 million and less than or equal to $800 million	4%
Greater than $800 million	1%

To be fair, if certain revenue thresholds are missed, the Initial Tier Royalty can increase to 9.5% starting January 1 of the following calendar year until a subsequent sales threshold is met.

Future Product Sales from the AFib-RVR Indication (Pipeline)

While PSVT is the immediate focus, the second indication for Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) represents a significant upside to future product sales, though it is further out on the timeline. Milestone Pharmaceuticals has finalized the Phase 3 protocol (ReVeRA-301), but enrollment initiation is currently paused to prioritize the PSVT launch readiness.

• The Phase 3 protocol for AFib-RVR is finalized.
• Enrollment initiation is paused to focus on the PSVT launch.
• Analyst projections suggest potential revenue over $1 billion if both PSVT and AFib-RVR indications are approved.

So, you're looking at a revenue model that transitions from a single, large, contingent payment in late 2025 to a commercial product stream in 2026, with a second, major revenue driver still in the pipeline. Finance: draft 13-week cash view by Friday.