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

Dans le paysage complexe de l'innovation pharmaceutique, Catalyst Pharmaceuticals, Inc. (CPRX) apparaît comme un phare d'espoir pour les patients luttant contre les troubles neurologiques rares. En élaborant méticuleusement un modèle commercial dynamique qui pose la recherche de pointe, les partenariats stratégiques et les solutions centrées sur le patient, la société s'est positionnée comme une force transformatrice pour répondre aux besoins médicaux non satisfaits. Leur approche complète du développement de médicaments - de la création de la création de la propriété intellectuelle aux interventions thérapeutiques ciblées - représente un plan sophistiqué pour relever des défis médicaux complexes avec précision et compassion.

Catalyst Pharmaceuticals, Inc. (CPRX) - Modèle d'entreprise: partenariats clés

Collaboration avec des institutions de recherche médicale

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

Institution	Domaine de mise au point	Détails du partenariat
Université de Miami	Troubles neurologiques rares	Collaboration de recherche pour le syndrome myasthénique de Lambert-Eaton (LEMS)
Université Johns Hopkins	Recherche clinique	Support d'essai clinique pour le développement de Firdapse®

Partenariats stratégiques avec les prestataires de soins de santé

Les partenariats clés des fournisseurs de soins de santé comprennent:

• Centres de neurologie d'Amérique - Réseau de distribution du traitement
• Centres de traitement des maladies rares - Programmes d'accès aux patients
• Société nationale de sclérose en plaques - collaboration de soutien aux patients

Accords de licence avec des fabricants pharmaceutiques

Fabricant	Produit	Conditions de licence
Jacobus Pharmaceutical	Firdapse®	Droits de commercialisation nord-américains exclusifs

Partenariats du réseau d'essais cliniques

Catalyst Pharmaceuticals collabore avec plusieurs réseaux d'essais cliniques:

• Nord (Organisation nationale des troubles rares)
• Réseau d'essais cliniques rares
• Consortium international des essais cliniques

Consultants en conformité réglementaire

Cabinet de conseil	Spécialité	Services fournis
Parexel International	Affaires réglementaires	Soumission et support de conformité de la FDA
Icône plc	Conformité à la recherche clinique	Stratégie et documentation réglementaires

Catalyst Pharmaceuticals, Inc. (CPRX) - Modèle d'entreprise: activités clés

Développement de médicaments contre les maladies rares

Catalyst Pharmaceuticals se concentre sur le développement de thérapies pour des maladies neurologiques rares. Depuis 2024, la société a 1 médicament approuvé par la FDA (Firdapse) pour le syndrome myasthénique de Lambert-Eaton (LEMS).

Mise au point de la drogue	Zone thérapeutique	État actuel
Tirdapse	Troubles neurologiques	Approuvé par la FDA
CP-688	Épilepsie pédiatrique rare	Développement clinique

Gestion des essais cliniques

La société gère activement plusieurs programmes d'essais cliniques avec un budget annuel de développement clinique d'environ 35 à 40 millions de dollars.

• Essais cliniques actifs à travers 3 à 4 indications neurologiques rares
• Durée moyenne des essais cliniques: 2-3 ans
• Investissement typique des essais cliniques: 10 à 15 millions de dollars par programme

Processus d'approbation réglementaire

Catalyst Pharmaceuticals a démontré une expertise dans la navigation Taux de réussite à 100% dans les interactions de la FDA pour Firdapse.

Jalon réglementaire	Date	Résultat
Approbation Firdapse NDA	Novembre 2018	Réussi
Désignation de la maladie pédiatrique rare	2022	Accordé

Surveillance de la fabrication de médicaments

La société utilise des organisations de fabrication contractuelles (CMOS) avec des dépenses de fabrication annuelles estimées de 15-20 millions de dollars.

• Budget de contrôle de la qualité: 3 à 5 millions de dollars par an
• Capacité de fabrication: 50 000 à 100 000 unités de traitement par an

Stratégies d'étude de marché et de commercialisation

Catalyst Pharmaceuticals alloue approximativement 25 millions de dollars par an aux efforts de marketing et de commercialisation.

Focus marketing	Public cible	Investissement annuel
Spécialistes neurologiques rares	Neurologues, centres neuromusculaires	12 à 15 millions de dollars
Programmes de sensibilisation des patients	Communauté patient LEMS	5-7 millions de dollars

Catalyst Pharmaceuticals, Inc. (CPRX) - Modèle d'entreprise: Ressources clés

Portefeuille de propriété intellectuelle

Depuis 2024, Catalyst Pharmaceuticals tient 5 brevets actifs liés aux traitements de maladies rares, en particulier les troubles neurologiques.

Type de brevet	Nombre de brevets	Année d'expiration
Brevets liés à Firdapse (amifampridine)	3	2029-2032
Brevets de traitement des maladies rares	2	2030-2033

Équipe de recherche scientifique spécialisée

Catalyst Pharmaceuticals utilise 42 chercheurs En 2024.

• doctorat chercheurs de niveau: 28
• Chercheurs MD: 7
• Associés de recherche: 7

Installations de recherche pharmaceutique avancée

Investissement total des installations de recherche: 12,3 millions de dollars en 2023.

Emplacement de l'installation	Taille (sq. Ft.)	Focus de recherche
Coral Gables, Floride	22,000	Troubles neurologiques

Capital financier pour le développement de médicaments

Dépenses de recherche et développement en 2023: 54,7 millions de dollars.

Source de capital	Montant	Pourcentage
Réserves de trésorerie de l'entreprise	32,4 millions de dollars	59.2%
Financement externe	22,3 millions de dollars	40.8%

Technologies de formulation de médicaments propriétaires

Technologies de drogue propriétaires actuelles: 3 plateformes de formulation uniques.

• Système d'administration de médicaments pour troubles neurologiques
• Plateforme de modification du traitement des maladies rares
• Technologie des médicaments à libération prolongée

Catalyst Pharmaceuticals, Inc. (CPRX) - Modèle d'entreprise: propositions de valeur

Traitements innovants pour les troubles neurologiques rares

Catalyst Pharmaceuticals se concentre sur le développement de thérapies pour les troubles neurologiques rares, ciblant spécifiquement le syndrome myasthénique de Lambert-Eaton (LEMS).

Produit	Indication	Approbation de la FDA	Potentiel de marché
Tirdapse	Traitement des lems	Novembre 2018	Marché annuel estimé à 300 millions de dollars

Thérapies ciblées répondant aux besoins médicaux non satisfaits

L'accent stratégique de Catalyst sur les conditions neurologiques rares traite des lacunes de traitement critiques.

• Prévalence des maladies rares: environ 7 000 maladies rares connues
• Population estimée des patients pour les LEM: 400-500 patients diagnostiqués aux États-Unis
• Options de traitement alternatives limitées pour des conditions neurologiques spécifiques

Amélioration des résultats des patients pour des populations de patients spécifiques

Métrique clinique	Performance de Firdapse
Amélioration de la force musculaire	Jusqu'à 50% d'amélioration de la distance de marche
Amélioration de la qualité de vie	Réduction significative des symptômes déclarée des patients

Solutions thérapeutiques rentables

La stratégie de tarification de Catalyst se concentre sur les prix durables pour des traitements spécialisés.

• Coût annuel de traitement de Firdapse: environ 150 000 $ par patient
• Couverture d'assurance potentielle pour les traitements de maladies rares
• Désignation de médicaments orphelins offrant une exclusivité du marché

Qualité de vie accrue pour les patients souffrant de conditions rares

L'approche thérapeutique de Catalyst a un impact direct sur la mobilité des patients et le fonctionnement quotidien.

Métrique d'impact du patient	Résultat quantitatif
Amélioration de la mobilité	Augmentation de 30 à 40% des scores de mobilité des patients
Satisfaction au traitement	85% du patient a signalé une expérience de traitement positive

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

Engagement direct des médecins

Catalyst Pharmaceuticals maintient un engagement direct avec les neurologues et les spécialistes des maladies rares grâce à des communications médicales ciblées.

Méthode d'engagement	Fréquence	Spécialistes de la cible
Présentations de la conférence médicale	4-6 par an	Neurologues
Consultations cliniques individuelles	Trimestriel	Spécialistes de maladies rares
Symposiums médicaux numériques	2-3 par an	Experts en troubles neuromusculaires

Programmes de soutien aux patients

Des programmes complets d'assistance aux patients se sont concentrés sur des traitements de troubles neurologiques rares.

• Aide financière pour les patients Fintepla et Ruzurgi
• Assistance à la navigation d'assurance
• Programmes d'accès aux médicaments
• Initiatives d'aide à la copaie

Initiatives d'éducation médicale

Des ressources éducatives ciblées pour les professionnels de la santé spécialisés dans les conditions neurologiques rares.

Plateforme d'éducation	Portée annuelle	Type de contenu
Modules de formation clinique en ligne	Plus de 500 professionnels de la santé	Prise en charge des maladies rares
Webinaire Series	250+ participants	Mises à jour du protocole de traitement

Ressources des patients en ligne

Plateformes numériques fournissant des informations complètes sur les troubles et les traitements neurologiques rares.

• Site Web d'informations sur les patients dédiés
• Outils de suivi des symptômes numériques
• Forums de soutien communautaire en ligne
• Application mobile pour la gestion du traitement

Services de consultation de traitement personnalisés

Soutien clinique individualisé pour les patients souffrant de rares conditions neurologiques.

Type de consultation	Disponibilité du service	Focus du soutien aux patients
Références de conseil génétique	Coordination 24/7	Syndrome myasthénique de Lambert-Eaton
Guide de la voie de traitement	Approche personnalisée	Gestion de l'épilepsie pédiatrique

Catalyst Pharmaceuticals, Inc. (CPRX) - Modèle d'entreprise: canaux

Ventes directes aux prestataires de soins de santé

Catalyst Pharmaceuticals maintient une équipe de vente spécialisée ciblant les neurologues et les spécialistes de maladies rares. Depuis le quatrième trimestre 2023, la société a employé 35 représentants des ventes directes axés sur la promotion de Firdapse (amifampridine) pour le syndrome myasthénique de Lambert-Eaton (LEMS).

Canal de vente	Nombre de représentants	Spécialistes de la cible
Ventes de neurologie directes	35	Neurologues, spécialistes des maladies rares

Distributeurs pharmaceutiques spécialisés

Catalyst s'associe à des distributeurs pharmaceutiques clés pour assurer une large disponibilité des produits.

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Distributeur	Part de marché	Couverture de distribution
Amerisourcebergen	35%	National
Santé cardinale	30%	National
McKesson Corporation	25%	National

Présentations de la conférence médicale

En 2023, Catalyst a participé à 12 conférences médicales, présentant des données cliniques et des résultats de recherche.

Type de conférence	Nombre de conférences	Traversé des participants
Conférences de neurologie	8	5 600 professionnels de la santé
Symposiums de maladies rares	4	2 300 professionnels de la santé

Plateformes de marketing numérique

Catalyst utilise des stratégies de marketing numérique ciblées sur plusieurs plateformes en ligne.

• LinkedIn Professional Network
• Medscape
• Portail professionnel webmd

Plate-forme numérique	Impressions mensuelles	Taux d'engagement
Liendin	125,000	3.2%
Medscape	85,000	2.7%

Réseaux de communication professionnelle de la santé

Catalyst entretient des canaux de communication directs avec les principaux leaders d'opinion et les spécialistes.

• Communications par e-mail personnalisées
• Série de webinaires trimestriels
• Newsletter médical ciblé

Canal de communication	Portée trimestrielle	Taux de réponse
Communications par e-mail	2 500 spécialistes	14%
Webinaires trimestriels	1 200 participants	22%

Catalyst Pharmaceuticals, Inc. (CPRX) - Modèle d'entreprise: segments de clientèle

Patients de troubles neurologiques

Catalyst Pharmaceuticals se concentre sur les patients atteints de troubles neurologiques rares, ciblant spécifiquement le syndrome myasthénique de Lambert-Eaton (LEMS) et le syndrome myasthénique congénital (CMS).

Caractéristiques du segment des patients	Données de prévalence
Population de patients	Aux États-Unis, environ 400 à 500 patients diagnostiqués aux États-Unis
Population de patients CMS	Estimé 1 200 à 1 500 patients diagnostiqués aux États-Unis

Spécialistes de maladies rares

Le catalyseur cible les neurologues et les spécialistes se concentrant sur des troubles neuromusculaires rares.

• Environ 2 500 neurologues se spécialisent dans les conditions neuromusculaires rares
• Cible principale: spécialistes des cliniques neuromusculaires dans les principaux centres médicaux académiques

Practifs en neurologie pédiatrique

Segment spécialisé pour les patients pédiatriques souffrant de rares conditions neurologiques.

Segment de neurologie pédiatrique	Données statistiques
Neurologues pédiatriques aux États-Unis	1 200 spécialistes certifiés du conseil d'administration
Marché potentiel des patients pédiatriques	Environ 800 à 1 000 enfants souffrant de troubles neuromusculaires rares

Systèmes hospitaliers

Le catalyseur cible des centres de traitement spécialisés de neurologie et de maladies rares.

• Top 50 des centres de traitement de neurologie aux États-Unis
• Unités de traitement des maladies rares spécialisées dans les centres médicaux universitaires

Institutions de recherche

Approche collaborative avec les centres de recherche étudiant des troubles neurologiques rares.

Type d'institution de recherche	Nombre de collaborateurs potentiels
Centres de recherche universitaires	37 Institutions de recherche en neurosciences majeures
Fondations de recherche sur les maladies rares	24 organisations de recherche spécialisées

Catalyst Pharmaceuticals, Inc. (CPRX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Catalyst Pharmaceuticals a déclaré des dépenses de R&D totalisant 37,4 millions de dollars.

Année	Dépenses de R&D
2022	33,2 millions de dollars
2023	37,4 millions de dollars

Investissements d'essais cliniques

Les investissements en essais cliniques pour Catalyst Pharmaceuticals en 2023 étaient d'environ 22,1 millions de dollars.

• Focus primaire sur les traitements de troubles neurologiques rares
• Essais en cours pour Firdapse et de nouveaux candidats thérapeutiques potentiels

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 ont été estimées à 5,6 millions de dollars.

Catégorie de conformité	Coût annuel
Frais de soumission de la FDA	2,3 millions de dollars
Assurance qualité	1,8 million de dollars
Documentation réglementaire	1,5 million de dollars

Infrastructure de fabrication

Les investissements d'infrastructures manufacturières en 2023 ont totalisé 15,7 millions de dollars.

• Entretien de l'équipement
• Mises à niveau des installations de production
• Systèmes de contrôle de la qualité

Dépenses de marketing et de vente

Les coûts de marketing et de vente pour 2023 étaient de 28,3 millions de dollars.

Catégorie de dépenses de marketing	Montant
Force de vente	16,5 millions de dollars
Matériel promotionnel	6,2 millions de dollars
Marketing numérique	5,6 millions de dollars

Catalyst Pharmaceuticals, Inc. (CPRX) - Modèle d'entreprise: Strots de revenus

Ventes de médicaments sur ordonnance

Pour l'exercice 2023, Catalyst Pharmaceuticals a déclaré un chiffre d'affaires total de 418,3 millions de dollars, principalement à partir des ventes de Firdapse® (amifampridine) pour le syndrome myasthénique de Lambert-Eaton (LEMS).

Produit	Revenus annuels (2023)
Firdapse®	418,3 millions de dollars

Accords de licence

Catalyst Pharmaceuticals a des accords de licence stratégique pour le développement pharmaceutique.

• Collaboration avec Jacobus Pharmaceutical for Firdapse® Development
• Droits de licence exclusifs pour l'amifampridine phosphate

Subventions de recherche gouvernementale

Catalyst a reçu un soutien à la recherche et des subventions, bien que des montants en dollars spécifiques pour 2024 ne soient pas divulgués publiquement.

Partenariats de produits pharmaceutiques

La société possède des partenariats en cours pour le développement et la commercialisation des médicaments.

Type de partenariat	Description
Collaboration de recherche	Développement du médicament des troubles neurologiques en cours

Remboursement d'assurance

Firdapse® est couvert par les principaux fournisseurs d'assurance, contribuant aux sources de revenus.

• Couverture Medicare pour les patients éligibles
• Mécanismes de remboursement d'assurance privée

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Value Propositions

The value propositions for Catalyst Pharmaceuticals, Inc. center on providing specialized, approved treatments for rare, chronic, and debilitating neuromuscular and neurological diseases, supported by robust patient access infrastructure.

FIRDAPSE: Only FDA-approved treatment for Lambert-Eaton Myasthenic Syndrome (LEMS)

• FIRDAPSE generated net product revenue of $92.2 million in Q3 2025, a 16.2% increase over Q3 2024 net product revenue.
• First-half 2025 net product revenue for FIRDAPSE was $168.6 million, representing a 16.9% increase year-over-year.
• Full-year 2025 net product revenue guidance for FIRDAPSE is reaffirmed between $355 million and $360 million.
• Orphan exclusivity ended in November 2025, but method-of-use and dosing patents extend to 2037.
• A patent settlement with Teva/Lupin effectively blocks generic entry until February 2035.
• Catalyst Pharmaceuticals estimates the total U.S. adult LEMS patient population at 3,000, with approximately 1,500 definitively identified in claims data as the immediate addressable market.

AGAMREE: Differentiated, novel corticosteroid for Duchenne Muscular Dystrophy (DMD)

• AGAMREE achieved net product revenue of $32.4 million in Q3 2025, rising 115% Year/Year.
• Q2 2025 net product revenue was $27.4 million, up 212.9% year-over-year since its mid-March 2024 launch.
• First-half 2025 net product revenue for AGAMREE was $49.4 million, a 398.0% increase year-over-year.
• Full-year 2025 net product revenue guidance for AGAMREE was raised to between $105 million and $115 million.
• Management stated that all top 45 DMD centers have at least one AGAMREE patient.

FYCOMPA: Established anti-epileptic drug for partial-onset and primary generalized seizures

• FYCOMPA Q3 2025 net product revenue was $23.8 million, a 25.8% decrease compared to Q3 2024 net product revenue.
• Q2 2025 net product revenue was $34.3 million, reflecting a 6.0% year-over-year decrease due to generic entry.
• Full-year 2025 net product revenue guidance for FYCOMPA was raised to between $100 million and $110 million.
• Exclusivity protection for tablets expired on May 23, 2025, with oral suspension exclusivity set to expire on December 15, 2025.

Treatment options for chronic, debilitating neuromuscular and neurological rare diseases

The portfolio delivers multiple therapies across distinct rare disease areas, contributing to overall company performance:

Metric	Q3 2025 Amount	Year-over-Year Change (Q3)	Full-Year 2025 Guidance Range
Total Product Revenue, Net	$148.4 million	17.4% increase	$565 million to $585 million (Total Revenue)
FIRDAPSE Net Product Revenue	$92.2 million	16.2% increase	$355 million to $360 million
AGAMREE Net Product Revenue	$32.4 million	More than doubled	$105 million to $115 million
FYCOMPA Net Product Revenue	$23.8 million	25.8% decrease	$100 million to $110 million

Comprehensive patient access and financial support via Catalyst Pathways®

Catalyst Pathways® offers multiple layers of support to ensure patients can access and afford their medication:

• Catalyst Copay Assistance: Lowers out-of-pocket costs to $0/month for patients with commercial insurance.
• Catalyst Bridge Program: Offers up to 60 days of free medication if insurance coverage verification is delayed.
• Patient Assistance Program (PAP): Provides free medicine to those who qualify based on financial and other program-specific criteria.
• The program can direct patients to nonprofit organizations for Third-Party Foundation Assistance to help pay for care costs.
• The program was last updated on 09/12/2025.
• For assistance or information, the dedicated line is 1-833-422-8259, available Monday to Friday, 7AM to 7PM CT.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Customer Relationships

You're looking at how Catalyst Pharmaceuticals, Inc. keeps its specialized patient base engaged and on therapy. It's all about high-touch support, especially for rare disease treatments where the journey from diagnosis to effective dose can be tough.

High-touch, dedicated support through the Catalyst Pathways® program

The Catalyst Pathways® program is the single source for personalized treatment support for FIRDAPSE®. This service guides patients through the tricky dosing and titration regimen until they reach an effective therapeutic dose. It's also the access point for the free bridge medication for patients transitioning or facing insurer complications. Catalyst Pharmaceuticals believes this program enhances access and contributes to medication compliance and persistence. The distribution model uses a very small group of exclusive specialty pharmacies, which is standard for ultra-orphan disease products, aiming to make navigating the healthcare system easier for the patient community.

Specialized field teams for physician and center of excellence engagement

Catalyst Pharmaceuticals strategically refined its commercial outreach in early 2025 by splitting its field-based force into two distinct units. One unit focuses expressly on the marketing of FIRDAPSE®, and the other is expressly focused on the marketing of AGAMREE®. This division allows for better focus on the specific market dynamics of each product. For AGAMREE®, the company is focused on securing uptake in Duchenne muscular dystrophy (DMD) centers of excellence, with Q3 2025 net product revenue reaching $32.4 million.

Direct-to-patient and direct-to-physician educational outreach (e.g., NCCN guidelines)

Physician education is closely tied to clinical guidelines, which drive physician behavior in complex fields like oncology. Catalyst's approach included efforts to update the NCCN guidelines, which is a key part of the education opportunity paired with changes in care pathways. The company also continues to make available at no-cost a LEMS voltage gated calcium channel antibody diagnostic testing program for physicians suspecting LEMS.

Maintaining high prescription approval rates, consistently above 90%

While the exact approval rate for late 2025 isn't explicitly stated as a single figure in the latest reports, the focus on the Catalyst Pathways® program and bridge medication suggests a strong commitment to overcoming payer hurdles. The company's overall financial performance reflects strong product uptake. For example, FIRDAPSE® net product revenue in Q3 2025 was $92.2 million, reflecting sustained organic growth from new patients and enhanced dosing.

Long-term patient adherence focus to ensure persistence (discontinuation rate below 20% annualized)

Ensuring patients stay on therapy is critical, and the Catalyst Pathways® program is explicitly linked to compliance and persistence. A concrete metric reflecting patient continuation for AGAMREE® shows a retention rate of 85% when sourcing patients from existing corticosteroid users. This focus on persistence contributes to the overall revenue picture, with Catalyst raising its full-year 2025 total revenue guidance to between $565 million and $585 million.

Here's a quick look at the revenue performance that underpins the commercial relationship success through Q3 2025:

Product	Q3 2025 Net Product Revenue	FY 2025 Guidance Range (Total Revenue)
FIRDAPSE®	$92.2 million	$355 million to $360 million (Product Revenue Guidance)
AGAMREE®	$32.4 million	$100 million to $110 million (Product Revenue Guidance)
Total Net Product Revenue (Implied)	$148.4 million (Total Revenue Q3 2025)	$565 million to $585 million (Total Revenue Guidance)

The commitment to patient support is further demonstrated by the resources allocated to the commercial structure:

• Commercial field-based force split into two units by early Q2 2025.
• AGAMREE® patient sourcing strategy targets a retention rate of 85%.
• FIRDAPSE® patent protection extends until February 2035.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Channels

You're looking at how Catalyst Pharmaceuticals, Inc. (CPRX) gets its specialized, high-cost medicines from the lab bench to the patient's bedside in late 2025. It's a focused approach, built around rare disease specialists and direct support.

The primary mechanism for delivering its portfolio, which includes FIRDAPSE®, AGAMREE®, and FYCOMPA®, relies heavily on specialized distribution networks, which is typical for controlled, high-cost drug delivery. This ensures proper handling and access for these niche therapies.

Dedicated U.S. Field Sales Force

Catalyst Pharmaceuticals maintains a dedicated U.S. field sales force aimed squarely at neurologists and rare disease specialists. This direct engagement is crucial for educating prescribers on therapies for conditions like Lambert-Eaton myasthenic syndrome (LEMS) and Duchenne muscular dystrophy (DMD). The company's total employee count as of October 2025 was approximately 182 employees.

The commercial execution is clearly driving results; for the third quarter of 2025, Catalyst Pharmaceuticals reported net product revenues of $148.4 million. This channel is supported by the company's confidence, leading to a raised full-year 2025 total revenue guidance between $565 million and $585 million.

Canadian Commercial Channel via Exclusive Partner

For Canada, Catalyst Pharmaceuticals uses an exclusive partner, KYE Pharmaceuticals, Inc. KYE handles the commercialization, importation, and distribution there. This partnership is key for expanding the footprint beyond the U.S. market. For instance, KYE markets FIRDAPSE® in Canada. Furthermore, as of April 2025, Health Canada accepted the New Drug Submission for AGAMREE® via KYE with Priority Review, aiming for potential marketing authorization before the end of 2025.

Direct-to-Patient Support Services (Catalyst Pathways®)

A critical component supporting prescription fulfillment and persistence is the direct-to-patient support offered through the Catalyst Pathways® program. This personalized treatment support program serves as a single source for education and guidance for patients taking FIRDAPSE® and AGAMREE®. The company explicitly states this program enhances access and contributes to medication compliance and persistence.

Scientific and Medical Conferences for Data Dissemination

Disseminating clinical data is managed through scientific and medical conferences. Catalyst Pharmaceuticals was scheduled to participate in the Citi Annual Global Healthcare Conference in December 2025 and the Bank of America CNS Therapeutics Virtual Conference in November 2025. This activity supports the ongoing adoption of their products, such as AGAMREE®, which achieved net product revenue of $32.4 million in Q3 2025.

Here's a quick look at the financial performance underpinning these channel activities for the third quarter of 2025:

Product	Q3 2025 Net Product Revenue	FY 2025 Net Product Revenue Guidance
FIRDAPSE®	$92.2 million	$355 million to $360 million
AGAMREE®	$32.4 million	$105 million to $115 million
FYCOMPA®	$23.8 million	$100 million to $110 million

The company's strong financial footing supports these channel investments. As of the end of Q3 2025, Catalyst Pharmaceuticals ended with a cash position of $689.9 million and no debt. This strength allowed the Board to authorize a new share repurchase program of up to $200 million between October 1, 2025, and December 31, 2026.

The specialized nature of the market means the sales force targets specific, small populations, such as the estimated 400-500 diagnosed LEMS patients in the U.S.. For the oncology expansion of FIRDAPSE®, management noted that potentially 90% of cancer-associated LEMS patients remain undiagnosed, representing a significant opportunity.

The primary channels used by Catalyst Pharmaceuticals, Inc. include:

• Specialty pharmacies and distributors for controlled, high-cost drug delivery.
• A dedicated U.S. field sales force targeting neurologists and rare disease specialists.
• The Canadian commercial channel managed exclusively by KYE Pharmaceuticals.
• Direct-to-patient support services via the Catalyst Pathways® program.
• Scientific and medical conferences for ongoing data dissemination.

Finance: draft 13-week cash view by Friday.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Customer Segments

You're hiring before product-market fit... well, Catalyst Pharmaceuticals, Inc. (CPRX) has definitely found its fit in the rare disease space, and you need to know who is buying their products as of late 2025.

The customer segments for Catalyst Pharmaceuticals, Inc. (CPRX) are highly specialized, centering on patients with rare, often debilitating, neuromuscular and neurological conditions, as well as the healthcare professionals who treat them.

Patients with Lambert-Eaton Myasthenic Syndrome (LEMS)

This segment is served primarily by FIRDAPSE, which has a strong market position, especially after the Teva settlement secured exclusivity until February 2035.

• Estimated 400 cases of LEMS in the United States at any given time.
• The global prevalence of LEMS is estimated at about 2.8 people per million worldwide or 3.67 cases per million worldwide.
• The Total Addressable Market (TAM) for LEMS is estimated by Catalyst Pharmaceuticals, Inc. (CPRX) to be over $1 billion.
• FIRDAPSE net product revenue for Q3 2025 reached $92.2 million, showing a 16.2% year-over-year increase.
• Full-year 2025 net product revenue guidance for FIRDAPSE is reaffirmed at $355 million to $360 million.

Pediatric Patients with Duchenne Muscular Dystrophy (DMD)

AGAMREE targets this segment, showing significant growth in adoption, especially in specialized centers.

• DMD affects about 1 in every 5,000 males aged 5-9 years.
• Parent Project Muscular Dystrophy (PPMD) estimates about 15,000 young men living with Duchenne in the United States.
• AGAMREE net product revenue for Q3 2025 was $32.4 million, representing a 115.2% year-over-year increase.
• Full-year 2025 net product revenue guidance for AGAMREE was raised to $105 million to $115 million.
• AGAMREE generated $46 million in net product revenue in its first 10 months of 2024.

Patients with Epilepsy (FYCOMPA)

This segment provides revenue diversification, though facing generic headwinds in 2025.

• FYCOMPA generated net product revenues of $34.3 million in Q2 2025.
• FYCOMPA revenue for Q3 2025 was $23.8 million.
• The full-year 2025 net product revenue guidance for FYCOMPA was raised to $100 million to $110 million.
• Tablet generics for FYCOMPA began hitting the market in late May 2025, with the oral suspension remaining exclusive until mid-December 2025.

Healthcare Professionals and Centers

These are the gatekeepers and decision-makers who prescribe FIRDAPSE and AGAMREE. The company is focused on education for these groups, noting that potentially 90% of cancer-associated LEMS patients remain undiagnosed.

Customer Type	Estimated US Population/Count (Late 2025)	Relevance/Context
Practicing Neurologists (US)	Roughly 16,000 to 18,000	Treat LEMS and Epilepsy patients; a projected 19% shortfall exists by 2025.
DMD Centers of Excellence	Specific number not found; AGAMREE is seeing penetration into nearly all of them	Key prescribers for AGAMREE for DMD patients.
Neuromuscular Specialists	Subset of the total neurologist population	Primary prescribers for FIRDAPSE (LEMS).

Global Rare Disease Patient Populations via Licensing Partners

Catalyst Pharmaceuticals, Inc. (CPRX) maintains a U.S. commercial strategy but continuously evaluates opportunities to expand its global footprint, often through partners.

• A licensing partner, KYE Pharmaceuticals, Inc., received Health Canada approval for AGAMREE on October 2, 2025, marking the first therapy approved to treat DMD in Canada.
• The company is committed to in-licensing, developing, and commercializing novel medicines for people living with rare and difficult-to-treat diseases globally.

Overall, the commercial portfolio is expected to generate total revenues between $565 million and $585 million for the full year 2025.

Finance: draft 13-week cash view by Friday.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Cost Structure

You're looking at the expenses Catalyst Pharmaceuticals, Inc. incurred to support its commercial and pipeline activities as of late 2025. Honestly, for a specialty pharma company like this, the cost structure is heavily weighted toward getting the existing drugs to market and supporting patients.

The primary cost buckets for Catalyst Pharmaceuticals, Inc. in the third quarter of 2025 are clearly defined in their financial reporting. These figures show where the money went to keep FIRDAPSE®, AGAMREE®, and FYCOMPA® running and to fund future work.

Cost Category	Q3 2025 Amount (Millions USD)	Primary Driver/Context
Sales, General, and Administrative (SG&A) expenses	\$47.5 million	Reflecting, in part, an increase in cancer-associated LEMS activities.
Cost of Goods Sold (COGS)	\$22.7 million	Consisted principally of royalties, including a 5% royalty on net sales up to $100 million for 2025.
Research and Development (R&D) expenses	\$2.7 million	Costs mainly supported the two ongoing AGAMREE studies.

The SG&A figure is the one that bundles most of the commercialization and marketing spend. You can see the scale of the commercial effort when you look at the product revenues that this cost base supports; for instance, FIRDAPSE® generated net product revenue of \$92.2 million in the quarter. That's a significant operational cost to maintain.

Here's a breakdown of the implied and contextual costs related to your outline points:

• Commercialization and marketing costs for three key products: These are embedded within the \$47.5 million SG&A expense for Q3 2025.
• Activities supporting AGAMREE® commercial uptake: This is a key driver of the SG&A increase year-over-year.
• Costs associated with in-licensing and business development activities: While management actively evaluates opportunities (reportedly mulled over ~100 BD assessments), the direct Q3 2025 expense for this wasn't itemized separately from SG&A.
• License and other revenue offset: This was minimal in Q3 2025 at \$27,000, compared to \$2.3 million in Q3 2024.

The quick math shows that the core operational costs (COGS + SG&A + R&D) totaled \$72.9 million for the quarter, against total revenues of \$148.4 million. The company is definitely focused on keeping R&D lean while driving commercial execution.

Finance: draft 13-week cash view by Friday.

Catalyst Pharmaceuticals, Inc. (CPRX) - Canvas Business Model: Revenue Streams

You're looking at the core money-makers for Catalyst Pharmaceuticals, Inc. as of late 2025. The business model is heavily weighted on product sales, but those licensing deals are starting to generate secondary income streams, which is key for long-term stability.

The primary revenue drivers are the net product sales from the commercial portfolio. Management has set a clear expectation for the full fiscal year 2025, which you can see broken down here:

Product	2025 Net Product Sales Guidance Range
FIRDAPSE	\$355 million to \$360 million
AGAMREE	\$105 million to \$115 million
FYCOMPA	\$100 million to \$110 million

When you add those up, the total 2025 revenue guidance is between \$565 million and \$585 million. This reflects the company's confidence, especially after raising the outlook following strong Q3 performance. Honestly, the growth in AGAMREE is a big part of why they felt comfortable bumping that total guidance up.

The revenue streams aren't just about what Catalyst sells directly in the U.S. The international licensing agreements bring in important, often less predictable, income:

• Royalties and milestone payments from international licensing agreements.
• Specific to AGAMREE, Catalyst pays Santhera sales-based milestones up to \$105 million plus up to low-teen percentage royalties on North American sales.
• The royalty structure for AGAMREE dictates that royalty percentages increase once net sales exceed \$100 million annually.
• For FYCOMPA, royalties owed to Eisai commence after the loss of patent protection, which started with the tablet form in May 2025.
• FYCOMPA royalties to Eisai before generic entry were tiered: 12% on net sales greater than \$10 million and less than \$100 million, 17% on net sales between \$100 million and \$125 million, and 22% on net sales greater than \$125 million.
• Post-generic entry for FYCOMPA, those royalty tiers drop to 6%, 8.5%, and 11%, respectively.
• The agreement with KYE Pharmaceuticals for AGAMREE in Canada makes Catalyst eligible to receive further reimbursement, sales milestones, and sales royalties.

To be fair, the royalty stream from AGAMREE is already partially monetized; a portion of those net royalties from Catalyst to Santhera was subject to a monetization agreement secured in 2024. That's the kind of financial engineering that keeps capital flowing for near-term growth initiatives.