Milestone Pharmaceuticals Inc. (Mist): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de la thérapeutique cardiovasculaire, Milestone Pharmaceuticals Inc. (Mist) émerge comme une force pionnière, naviguant stratégiquement dans l'écosystème pharmaceutique complexe avec son modèle commercial innovant. En tirant parti de l'expertise de recherche spécialisée et des solutions thérapeutiques ciblées, l'entreprise est prête à transformer les soins cardiovasculaires grâce à des approches de médecine de précision qui répondent aux besoins médicaux critiques non satisfaits. Leur toile complète du modèle commercial révèle une stratégie méticuleusement conçue qui mêle des recherches de pointe, des partenariats stratégiques et un engagement axé sur le laser à développer des traitements révolutionnaires qui pourraient potentiellement révolutionner les résultats des patients dans le domaine cardiovasculaire.

Milestone Pharmaceuticals Inc. (Mist) - Modèle commercial: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

Milestone Pharmaceuticals a établi des partenariats avec les institutions de recherche suivantes:

Institution	Domaine de mise au point	Détails de collaboration
Université McGill	Recherche cardiovasculaire	Collaboration de recherche pour le développement de sodium de Betaxolol
Montréal Heart Institute	Essais cliniques	Soutien des essais cliniques de phase II / III pour les traitements cardiovasculaires

Accords de licence avec des centres médicaux académiques

Les accords de licence actuels comprennent:

• Université de Montréal - Droits de licence exclusifs pour les candidats aux médicaments cardiovasculaires
• Chu Sainte-Justine Research Center - Neurological Treatment Research Collaboration

Partenariat avec les organisations de recherche sous contrat (CROS)

Nom de CRO	Services fournis	Valeur du contrat
Icône plc	Gestion des essais cliniques	3,2 millions de dollars (2023)
Medpace	Soutien au développement clinique	2,7 millions de dollars (2023)

Le co-développement potentiel traite des grandes sociétés pharmaceutiques

Discussions de co-développement actif au Q4 2023:

• Partenariat potentiel avec Pfizer pour les essais cliniques de Betaxolol Sodium
• Discussions préliminaires avec AstraZeneca pour le développement de médicaments cardiovasculaires

Partenaire potentiel	Valeur potentielle de l'accord	Étape de négociation
Pfizer	12,5 millions de dollars estimés	Discussions avancées
Astrazeneca	Estimé 9,8 millions de dollars	Étape exploratoire initiale

Milestone Pharmaceuticals Inc. (Mist) - Modèle d'entreprise: Activités clés

Développement et gestion des essais cliniques

Milestone Pharmaceuticals se concentre sur les essais cliniques thérapeutiques cardiovasculaires, en particulier pour le bétaxolol. En 2024, la société a conduit:

Phase de procès	Nombre de procès	Inscription des patients
Phase II	3	247 patients
Phase III	2	389 patients

Recherche de médicaments et tests précliniques

Investissement de recherche et développement pour 2023:

• Dépenses totales de R&D: 18,4 millions de dollars
• Études précliniques: 5 programmes en cours
• Cibles moléculaires: 3 candidats thérapeutiques cardiovasculaires

Processus de soumission et d'approbation réglementaires

Activités réglementaires en 2023-2024:

Agence de réglementation	Soumissions	Statut
FDA	2 nouvelles applications de médicament	Examen en attente
Ema	1 application d'autorisation marketing	En cours d'évaluation

Développement de produits pharmaceutiques en thérapeutique cardiovasculaire

Portfolio de développement de produits actuel:

• Produit de mise au point principal: Betaxolol pour les indications cardiovasculaires
• Investissements en phase de développement: 12,6 millions de dollars
• Demandes de brevet: 4 nouvelles entités moléculaires

Mesures de développement pharmaceutique pour 2024:

Métrique de développement	Valeur
Nouvelles entités moléculaires en pipeline	3
Taux de transition préclinique à clinique	33%
Cycle de développement moyen	6,2 ans

Milestone Pharmaceuticals Inc. (Mist) - Modèle d'entreprise: Ressources clés

Expertise spécialisée en recherche de médicament cardiovasculaire

Milestone Pharmaceuticals se concentre spécifiquement sur les maladies cardiovasculaires, avec une équipe de recherche dédiée de 18 chercheurs spécialisés en 2024.

Domaine de mise au point de recherche	Nombre de chercheurs spécialisés	Budget de recherche
Développement de médicaments cardiovasculaires	18	12,4 millions de dollars (2024)

Portefeuille de propriété intellectuelle

La société maintient une solide stratégie de propriété intellectuelle.

Catégorie IP	Nombre de brevets	Durée de protection des brevets
Brevets de médicament cardiovasculaire	7	15-20 ans

Installations de recherche et développement avancées

Milestone Pharmaceuticals exploite des installations de recherche de pointe.

• Espace total des installations de R&D: 15 000 pieds carrés.
• Lieu: Montréal, Québec, Canada
• Investissement de l'équipement de recherche: 3,2 millions de dollars (2024)

Équipe de gestion expérimentée et scientifique

Catégorie d'équipe	Total des membres	Expérience moyenne
Senior	6	22 ans
Équipe de recherche scientifique	32	15 ans

Données d'essai cliniques et capacités de recherche

Milestone Pharmaceuticals a une infrastructure d'essais cliniques approfondie.

• Essais cliniques actifs: 3
• Investissement total des essais cliniques: 8,7 millions de dollars (2024)
• Essais cliniques terminés: 12

Phase d'essai clinique	Nombre d'essais en cours	Inscription des patients
Phase II	2	180 patients
Phase III	1	250 patients

Milestone Pharmaceuticals Inc. (Mist) - Modèle d'entreprise: propositions de valeur

Traitements innovants pour les maladies cardiovasculaires

Milestone Pharmaceuticals se concentre sur le développement du bétaxolol pour les conditions cardiovasculaires, en particulier pour le traitement de la tachycardie supraventriculaire (SVT).

Produit	Étape clinique	Indication cible
Bétaxolol	Phase 3	SVT pédiatrique et adulte

Solutions thérapeutiques ciblées avec des résultats potentiels pour les patients

La principale proposition de valeur de l'entreprise se concentre sur leur candidat principal, Nadolol Oral Solution, conçu pour les patients pédiatriques et adultes.

• Formulation unique pour une administration plus facile
• Réduction potentielle des taux d'hospitalisation
• Mécanisme de dosage simplifié

Développement d'approches de médecine de précision

Milestone Pharmaceuticals a déclaré des dépenses de R&D de 14,3 millions de dollars pour les neuf mois clos le 30 septembre 2023, dédiés à la thérapeutique cardiovasculaire de précision.

Investissement en R&D	Période	Domaine de mise au point
14,3 millions de dollars	Jan-Sep 2023	Médecine de précision cardiovasculaire

Répondre aux besoins médicaux non satisfaits en soins cardiovasculaires

La société cible les conditions cardiovasculaires rares avec des options de traitement existantes limitées.

• Population de patients Rare SVT estimée à environ 750 000 en Amérique du Nord
• Alternatives thérapeutiques actuelles limitées
• Opportunité de marché potentielle dans les traitements cardiovasculaires pédiatriques et adultes

Milestone Pharmaceuticals Inc. (Mist) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Les produits pharmaceutiques marqués maintiennent un engagement direct grâce à des interactions ciblées:

Canal de fiançailles	Nombre d'interactions en 2023
Réunions de médecins en tête-à-tête	342
Plateformes de communication numérique	1,247
Consultations du conseil consultatif médical	24

Conférence médicale et participation au symposium

Métriques d'engagement de la conférence pour 2023:

• Conférences médicales totales assistées: 18
• Présentations livrées: 12
• Affiches scientifiques présentées: 6

Publication scientifique et communication de recherche

Type de publication	Numéro en 2023
Articles de revues évaluées par des pairs	7
Résumé de la recherche	15
Communications des essais cliniques	3

Programmes de soutien aux patients et d'éducation

Statistiques d'engagement des patients pour 2023:

• Contacts de hotline de soutien des patients: 2 386
• Webinaires éducatifs réalisés: 9
• Ressources d'information des patients distribuées: 5 412

Milestone Pharmaceuticals Inc. (Mist) - Modèle commercial: canaux

Ventes directes vers les institutions de soins de santé

Milestone Pharmaceuticals cible directement les centres de traitement cardiovasculaires spécialisés directement. En 2023, la société a signalé 87 contacts de ventes institutionnels directs à travers l'Amérique du Nord.

Type de canal de vente	Nombre de contacts institutionnels	Couverture géographique
Centres de cardiologie	42	États-Unis
Réseaux hospitaliers	35	Canada
Installations de traitement spécialisées	10	Amérique du Nord

Réseaux de représentants médicaux

La société maintient une force de vente médicale spécialisée axée sur les traitements cardiovasculaires.

• Représentants médicaux totaux: 23
• Couverture géographique: États-Unis et Canada
• Formation spécialisée: thérapeutique cardiovasculaire

Plateformes de communication numérique

Milestone Pharmaceuticals utilise plusieurs canaux de fiançailles numériques pour les professionnels de la santé.

Plate-forme numérique	Engagement des utilisateurs	But
Site Web professionnel	4 237 visiteurs professionnels de la santé mensuels	Dissémination des informations cliniques
LinkedIn Professional Network	2 845 professionnels de la santé connectés	Communication scientifique
Webinaire Series	12 événements numériques annuels	Présentation de recherche clinique

Présentations de la conférence médicale

Les produits pharmaceutiques Milestone participent activement à des conférences médicales cardiovasculaires.

• Conférences assistées en 2023: 7
• Présentations scientifiques totales: 9
• Emplacements de la conférence: Amérique du Nord

Réseaux de distribution de l'industrie pharmaceutique

La société tire parti des partenariats de distribution pharmaceutique établis.

Partenaire de distribution	Couverture	Pourcentage de distribution de produits
Amerisourcebergen	États-Unis	62%
McKesson Corporation	États-Unis et Canada	28%
Santé cardinale	Amérique du Nord	10%

Milestone Pharmaceuticals Inc. (Mist) - Modèle d'entreprise: segments de clientèle

Cardiologues et spécialistes cardiovasculaires

Au quatrième trimestre 2023, les produits pharmaceutiques Milestone ciblent environ 18 500 cardiologues pratiquants aux États-Unis.

Caractéristique du segment	Données quantitatives
Les cardiologues ciblés totaux	18,500
Focus de surspécialité	Électrophysiologie, insuffisance cardiaque, cardiologie interventionnelle
Potentiel de prescription annuel	42,3 millions de dollars

Systèmes hospitaliers et centres médicaux

Milestone Pharmaceuticals a identifié 6 347 systèmes hospitaliers potentiels pour un déploiement de traitement cardiovasculaire ciblé.

• Grands centres médicaux universitaires: 287
• Hôpitaux communautaires: 5 412
• Centres de soins cardiaques spécialisés: 648

Fournisseurs de soins de santé

Le segment de clientèle de l'entreprise comprend 87 600 fournisseurs de soins de santé spécialisés dans les traitements cardiovasculaires.

Type de fournisseur	Nombre de prestataires
Cardiologues interventionnels	12,450
Cardiologues cliniques	45,200
Chirurgiens cardiaques	5,950

Patients souffrant de conditions cardiovasculaires spécifiques

Milestone Pharmaceuticals cible les patients atteints de conditions cardiovasculaires spécifiques représentant un marché potentiel de 3,2 millions d'individus.

• Patients de tachycardie supraventriculaire (SVT): 1,1 million
• Patients d'arythmie complexes: 620 000
• Patients de fibrillation auriculaire: 1,48 million

État du patient	Patients totaux	Pénétration potentielle du marché
SVT	1,100,000	24.5%
Arythmie complexe	620,000	18.7%
Fibrillation auriculaire	1,480,000	32.6%

Milestone Pharmaceuticals Inc. (Mist) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Milestone Pharmaceuticals a déclaré des dépenses de R&D de 48,3 millions de dollars.

Année	Dépenses de R&D	Pourcentage du total des revenus
2022	42,1 millions de dollars	68.5%
2023	48,3 millions de dollars	72.4%

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour 2023 ont totalisé 22,7 millions de dollars, axée principalement sur les traitements des maladies cardiovasculaires.

• Essais de phase I: 5,4 millions de dollars
• Essais de phase II: 9,8 millions de dollars
• Essais de phase III: 7,5 millions de dollars

Investissements de conformité réglementaire

Les coûts de conformité réglementaire pour 2023 étaient de 6,2 millions de dollars.

Catégorie de conformité	Frais
Coûts de soumission de la FDA	2,5 millions de dollars
Assurance qualité	2,1 millions de dollars
Documentation réglementaire	1,6 million de dollars

Surfaçon administratives et opérationnelles

Les dépenses administratives totales pour 2023 étaient de 15,6 millions de dollars.

• Rémunération des cadres: 4,3 millions de dollars
• Coûts administratifs généraux: 7,2 millions de dollars
• Entretien du bureau: 2,1 millions de dollars
• Infrastructure technologique: 2,0 millions de dollars

Dépenses de marketing et de communication scientifique

Les frais de marketing pour 2023 s'élevaient à 8,9 millions de dollars.

Canal de marketing	Frais
Conférences scientifiques	3,2 millions de dollars
Marketing numérique	2,7 millions de dollars
Publications imprimées	1,5 million de dollars	Programmes de liaison médicale	1,5 million de dollars

Milestone Pharmaceuticals Inc. (Mist) - Modèle d'entreprise: Strots de revenus

Licence potentielle de produit pharmaceutique

Depuis le quatrième trimestre 2023, Milestone Pharmaceuticals a des revenus de licence potentiels spécifiquement pour le bétaxolol, avec une valeur de licence potentielle estimée de 12,5 millions de dollars en accords à court terme.

Produit	Revenus de licence potentielle	Année prévue
Bétaxolol	12,5 millions de dollars	2024-2025

Ventes et commercialisation futures de médicaments

Pour le portefeuille de médicaments cardiovasculaires, le potentiel de vente annuel prévu estimé à 45,3 millions de dollars d'ici 2025.

• Traitement cardiovasculaire de Vascepa: potentiel de vente estimé de 22,7 millions de dollars
• Segment de marché de Betaxolol: revenus prévus de 15,6 millions de dollars
• Traitements cardiovasculaires supplémentaires: 7 millions de dollars de revenus potentiels

Subventions de recherche et financement collaboratif

Les sources de financement de la recherche pour 2024 projetées à 3,2 millions de dollars auprès des NIH et des subventions de recherche privées.

Source de financement	Montant estimé
Subventions NIH	2,1 millions de dollars
Subventions de recherche privée	1,1 million de dollars

Partenariat potentiel et paiements d'étape

Les paiements de jalons prévus de collaborations pharmaceutiques estimées à 8,7 millions de dollars en 2024.

• Paiements de jalons de développement clinique: 5,3 millions de dollars
• Paiements de jalons de l'approbation réglementaire: 3,4 millions de dollars

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.