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

Plongez dans le monde innovant de Fennec Pharmaceuticals Inc. (FENC), une entreprise de biotechnologie pionnière révolutionnant l'oncologie pédiatrique à travers des solutions pharmaceutiques de pointe. En répondant stratégiquement aux besoins médicaux critiques non satisfaits dans les maladies rares de l'enfance, Fennec transforme la recherche scientifique complexe en traitements qui changent la vie qui offrent de l'espoir où la médecine traditionnelle est absente. Leur toile de modèle commercial méticuleusement conçu révèle une approche sophistiquée pour développer des médicaments spécialisés qui promettent d'améliorer considérablement les résultats des soins de santé pédiatriques et de fournir des interventions révolutionnaires aux jeunes patients vulnérables.

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: partenariats clés

Institutions de recherche pharmaceutique

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

Institution	Focus de la collaboration	Année établie
Hôpital de recherche pour enfants St. Jude	Développement de médicaments en oncologie pédiatrique	2016
Duke University Medical Center	Recherche d'essais cliniques	2018

Organisations de fabrication de contrats

Les principaux partenariats de fabrication comprennent:

• Patheon Pharmaceuticals (une société scientifique Thermo Fisher)
• Lonza Group AG

Centres de traitement en oncologie pédiatrique

Le réseau de collaboration comprend:

Centre de traitement	Emplacement	Portée du partenariat
Memorial Sloan Kettering Cancer Center	New York, NY	Essais cliniques pour le pendarme
Dana-Farber Cancer Institute	Boston, MA	Recrutement et recherche des patients

Organismes de réglementation

Partenariats réglementaires critiques:

• Administration américaine de l'alimentation et du médicament (FDA)
• Agence européenne des médicaments (EMA)

Réseaux de recherche médicale académique

Détails de la collaboration de recherche:

Réseau	Focus de recherche	Valeur de collaboration
Groupe d'oncologie pour enfants	Recherche sur le cancer pédiatrique	Soutien annuel de la recherche de 1,2 million de dollars
Institut national du cancer	Soutien en essai clinique	Financement de subventions de 850 000 $

Investissement total de partenariat: environ 3,5 millions de dollars par an

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: Activités clés

Développement de traitements pharmaceutiques pédiatriques

Fennec Pharmaceuticals se concentre sur le développement du pendarme (thiosulfate de sodium) pour l'otoprotection chez les patients atteints de cancer pédiatrique. En 2023, la société a terminé l'essai clinique de phase 3 pour prévenir la perte auditive induite par le cisplatine chez les patients pédiatriques.

Focus du traitement	État actuel	Population de patients
Pendarme (thiosulfate de sodium)	FDA Nouvelle demande de médicament soumise	Patients atteints de cancer pédiatrique

Effectuer des essais cliniques pour des médicaments contre les maladies rares

Les activités de développement clinique sont centrées sur l'oncologie pédiatrique et les traitements de maladies rares.

• Total des dépenses d'essais cliniques en 2022: 4,2 millions de dollars
• Essais cliniques actifs: 1 étude principale pour le pendarme
• Focus de la recherche: Otoprotection dans la chimiothérapie du cancer pédiatrique

Obtention des approbations réglementaires

La stratégie réglementaire implique des interactions ciblées de la FDA pour l'approbation du Pedmark.

Jalon réglementaire	Date	Statut
FDA Nouvelle application de médicament	Novembre 2023	Soumis

Gestion du pipeline de développement de médicaments

Stratégie de développement de médicaments ciblé avec un pipeline pharmaceutique limité mais ciblé.

• Candidat au médicament principal: pendarme
• Investissement en R&D en 2022: 5,1 millions de dollars
• Concentration de pipeline: soins de soutien à l'oncologie pédiatrique

Commercialiser des produits pharmaceutiques pédiatriques spécialisés

Préparation pour l'introduction potentielle du marché du pendarme.

Aspect de commercialisation	Stratégie	Investissement projeté
Préparation du marché	Spécialistes ciblés en oncologie	2,5 millions de dollars

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: Ressources clés

Équipe de recherche pharmaceutique spécialisée

En 2024, Fennec Pharmaceuticals maintient une équipe de recherche axée sur les maladies pédiatriques rares. L'équipe se compose de 12 chercheurs spécialisés ayant une expertise en développement pharmaceutique.

Composition de l'équipe de recherche	Nombre de professionnels
Chercheurs de doctorat	7
Spécialistes de la recherche clinique	5

Portefeuille de propriété intellectuelle

Fennec Pharmaceuticals tient 3 brevets pharmaceutiques actifs liés aux formulations de médicaments pédiatriques.

• Brevet pour pendark® (thiosulfate de sodium) pour l'otoprotection
• Brevet pour le développement de médicaments en oncologie pédiatrique
• Méthodologie de traitement des maladies rares

Données et recherche sur les essais cliniques

L'entreprise a accumulé des données d'essai cliniques de 2 essais cliniques de phase III terminés En 2024.

Métriques des essais cliniques	Points de données
Participants aux patients totaux	218
Investissement en recherche	6,3 millions de dollars

Technologies de formulation de médicaments propriétaires

Fennec Pharmaceuticals a développé Technologies uniques d'administration de médicaments spécialement conçu pour les patients pédiatriques.

• Technologie de formulation posologique spécifique à la pédiatrie
• Mécanisme d'absorption de médicament amélioré
• Technologie du prototype d'effet secondaire réduit

Financement stratégique et capital d'investissement

Ressources financières au quatrième trimestre 2023:

Source de capital	Montant
Equivalents en espèces et en espèces	14,7 millions de dollars
Total des capitaux propres des actionnaires	37,2 millions de dollars
Budget de recherche et de développement	5,9 millions de dollars

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: propositions de valeur

Solutions pharmaceutiques pédiatriques innovantes

Fennec Pharmaceuticals se concentre sur le développement Pendarme (thiosulfate de sodium), un médicament de prévention de la perte auditive induite par la chimiothérapie ciblée pour les patients atteints de cancer pédiatrique.

Caractéristique des médicaments	Détails spécifiques
Indication cible	Perte auditive induite par le cisplatine pédiatrique
Étape clinique	Approbation de la FDA en attente
Population potentielle de patients	Environ 4 000 à 5 000 patients atteints de cancer pédiatrique chaque année

Traitements ciblés pour les maladies rares de l'enfance

Intervention pharmaceutique spécialisée pour des défis spécifiques en oncologie pédiatrique.

• Mécanisme unique pour prévenir la perte auditive pendant la chimiothérapie
• Toxicité systémique minimale
• Préservation de la fonction sensorielle critique

Interventions médicales spécialisées de haute qualité

Paramètre d'intervention	Métrique quantitative
Investissement en recherche	12,4 millions de dollars (2023 Exercice)
Dépenses d'essais cliniques	8,7 millions de dollars
Durée de protection des brevets	Jusqu'en 2037

Répondre aux besoins médicaux non satisfaits en oncologie pédiatrique

Opportunité de marché pour la prévention des pertes auditives dans le traitement du cancer pédiatrique.

• Aucune solutions actuelles approuvées par la FDA pour la perte auditive induite par le cisplatine
• Taille du marché potentiel estimé à 150 à 200 millions de dollars par an
• Besoins médicaux non satisfaits en oncologie pédiatrique

Approches thérapeutiques avancées avec un minimum d'effets secondaires

Le thiosulfate de sodium démontre un potentiel de protection auditive avec un impact systémique limité.

Attribut thérapeutique	Évaluation quantitative
Efficacité de la protection auditive	Réduction jusqu'à 75% du risque de perte auditive
Sécurité du traitement Profile	Toxicité systémique minimale observée dans les essais cliniques
Économies potentielles	Estimé 50 000 $ à 100 000 $ par patient en soins auditifs à long terme

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: relations clients

Engagement direct avec les prestataires de soins de santé pédiatriques

Fennec Pharmaceuticals maintient un engagement direct à travers:

Canal de fiançailles	Fréquence	Spécialistes de la cible
Conférences en oncologie	4-6 par an	Oncologues pédiatriques
Réunions de conseil médical	2-3 par trimestre	Spécialistes pédiatriques

Collaboration en cours de recherche médicale

Les mesures de collaboration de recherche comprennent:

• Partenariats de recherche actifs: 7 collaborations institutionnelles
• Investissement annuel de recherche: 2,3 millions de dollars
• Engagement des essais cliniques: 3-4 essais simultanés

Programmes de soutien aux patients et d'éducation

Infrastructure de soutien des patients:

Type de programme	Couverture	Portée annuelle
Programme d'aide aux patients	Patients de traitement pedmark®	Environ 200-250 patients
Réseau de soutien familial	Centres d'oncologie pédiatrique à l'échelle nationale	Plus de 35 établissements de santé

Services de consultation médicale technique

Détails du service de consultation:

• Équipe dévouée des affaires médicales: 6 spécialistes
• Temps de réponse: dans les 24 à 48 heures
• Canaux de consultation: téléphone, e-mail, réunions virtuelles

Communication transparente sur les développements du traitement

Métriques de transparence de la communication:

Canal de communication	Fréquence	Public
Mises à jour des essais cliniques	Trimestriel	Fournisseurs de soins de santé, investisseurs
Présentations des relations avec les investisseurs	Bi-annuellement	Actionnaires, analystes financiers

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: canaux

Ventes directes vers les hôpitaux pédiatriques

Fennec Pharmaceuticals se concentre sur les ventes directes vers des hôpitaux spécialisés en oncologie pédiatrique. En 2024, la société cible environ 180 centres de traitement du cancer pédiatrique aux États-Unis.

Type de canal	Nombre d'institutions cibles	Taux de pénétration
Hôpitaux en oncologie pédiatrique	180	62%
Centres de cancer des enfants	95	41%

Présentations de la conférence médicale

Fennec Pharmaceuticals utilise des conférences médicales comme canal critique pour la sensibilisation des produits et l'adoption clinique.

• Participation annuelle à 12-15 conférences en oncologie
• Association moyenne de la conférence: 3 500 professionnels de la santé
• Les conférences ciblées comprennent la société américaine d'hématologie / oncologie américaine

Réseaux de distribution pharmaceutique

L'entreprise tire parti de plusieurs canaux de distribution pharmaceutique pour la livraison de produits.

Partenaire de distribution	Couverture du marché	Volume de distribution annuel
Amerisourcebergen	National	65% de la distribution totale
Santé cardinale	National	35% de la distribution totale

Plateformes d'information médicale en ligne

Fennec Pharmaceuticals maintient les canaux numériques pour les professionnels de la santé et les chercheurs.

• Trafic de site Web: 42 000 visiteurs uniques mensuellement
• Téléchargements de ressources numériques: 1 250 par trimestre
• Participation du webinaire: 350-450 professionnels de la santé par session

Canaux de communication professionnels de la santé

L'entreprise emploie des stratégies de communication spécialisées pour les professionnels de la santé.

Méthode de communication	Fréquence	Atteindre
Campagnes par e-mail directes	Trimestriel	5 200 spécialistes d'oncologie
Publicités de journal médical	Bimensuel	7 publications d'oncologie spécialisées
Sensibilisation des représentants médicaux ciblés	Mensuel	95 centres de traitement du cancer clés

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: segments de clientèle

Spécialistes en oncologie pédiatrique

Taille du marché cible: environ 2 500 spécialistes en oncologie pédiatrique aux États-Unis en 2023.

Caractéristiques du segment	Données statistiques
Nombre de spécialistes en oncologie pédiatrique	2,500
Références moyennes des patients par spécialiste	12-15 patients par an

Hôpitaux pour enfants

Couverture complète du réseau: 220 hôpitaux pour enfants spécialisés aux États-Unis.

Segment de l'hôpital	Données quantitatives
Hôpitaux totaux pour enfants	220
Patients atteints de cancer pédiatrique annuel traité	17,500

Centres de traitement des maladies rares

Paysage de traitement spécialisé: 87 centres de traitement des maladies rares dédiées en Amérique du Nord.

• Centres de traitement des maladies rares totales: 87
• Volume annuel des patients atteints de maladies rares: 3200
• Pénétration potentielle du marché: 45%

Institutions de recherche médicale pédiatrique

Écosystème de recherche: 135 institutions de recherche médicale pédiatriques aux États-Unis.

Métriques de l'institution de recherche	Données numériques
Institutions de recherche pédiatrique totale	135
Financement de la recherche annuelle	2,3 milliards de dollars

Les familles à la recherche de traitements médicaux spécialisés

Analyse démographique cible pour les traitements de maladies rares pédiatriques.

• Familles de patients potentiels totaux: 12 500
• Dépenses de santé annuelles moyennes par famille: 45 000 $
• Taux de couverture d'assurance: 68%

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Fennec Pharmaceuticals a déclaré des dépenses en R&D de 4,72 millions de dollars, contre 5,29 millions de dollars en 2022.

2022

5,29 millions de dollars

2023

4,72 millions de dollars

Exercice fiscal	Dépenses de R&D

Investissements d'essais cliniques

Les investissements totaux d'essais cliniques pour le développement de pendark® étaient d'environ 23,4 millions de dollars à 2023.

Coûts de conformité réglementaire

Les dépenses annuelles de conformité réglementaire pour Fennec Pharmaceuticals ont été estimées à 1,5 million de dollars en 2023.

Fabrication et production

Les coûts de fabrication pour PEDMARK® étaient d'environ 2,3 millions de dollars en 2023.

Catégorie de coûts	Montant (2023)
Matières premières	$850,000
Travail de production	$750,000
Entretien de l'équipement	$700,000

Marketing et sensibilisation professionnelle

Les frais de marketing pour 2023 ont totalisé 3,1 millions de dollars.

• Participation de la conférence professionnelle: 450 000 $
• Campagnes de marketing numérique: 750 000 $
• Coûts opérationnels de l'équipe de vente: 1,9 million de dollars

Fennec Pharmaceuticals Inc. (FENC) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

La source de revenus primaire de Fennec Pharmaceuticals provient de son peintre de médicament approuvé par la FDA (thiosulfate de sodium) pour la prévention de la perte auditive pédiatrique. Au quatrième trimestre 2023, la société a rapporté:

Produit	Ventes annuelles	Segment de marché
Claquement	4,2 millions de dollars	Oncologie pédiatrique

Licence de propriété intellectuelle

Les revenus de licence pour les technologies pharmaceutiques propriétaires et les processus de développement de médicaments:

• Les accords de licence de propriété intellectuelle ont généré 1,1 million de dollars en 2023
• Le portefeuille de brevets comprend 7 brevets de technologie pharmaceutique active

Subventions de recherche

Sources de financement de la recherche:

Source d'octroi	Montant d'octroi	Focus de recherche
National Institutes of Health (NIH)	$750,000	Pédiatrie en oncologie Soins de soutien
Fondation de recherche sur le cancer	$350,000	Développement de médicaments

Partenariats stratégiques

Génération de revenus collaboratifs:

• Partenariat avec les centres de traitement en oncologie générant 600 000 $ par an
• Accords de distribution pharmaceutique contribuant 450 000 $ en 2023

Remboursements du gouvernement

Réimpression des revenus de remboursement:

Catégorie de remboursement	Revenus annuels	Programme de soins de santé
Remboursements de l'assurance-maladie	2,3 millions de dollars	Traitement en oncologie pédiatrique
Remboursements de Medicaid	1,7 million de dollars	Prévention de la perte auditive

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Value Propositions

You're looking at the core reason Fennec Pharmaceuticals Inc. exists: the unique value delivered by PEDMARK® (sodium thiosulfate injection). This isn't just another drug; it's the first solution to a devastating, common side effect of life-saving cancer treatment.

First and only FDA-approved therapy to reduce cisplatin-induced ototoxicity

PEDMARK® holds the distinction of being the first and only therapy approved by the U.S. Food and Drug Administration (FDA) specifically indicated to reduce the risk of ototoxicity (hearing loss) linked to cisplatin in pediatric patients aged 1 month and older with localized, non-metastatic, solid tumors. This exclusivity is a massive part of the value proposition, as it means no other approved product offers this targeted protection.

Addresses a critical, previously unmet medical need in childhood cancer

Before PEDMARK® received FDA approval in September 2022, there were no preventative agents available for this hearing loss. Cisplatin chemotherapy is vital for treating solid tumors, but the side effect is severe: permanent, irreversible hearing loss affects between 60 percent and 90 percent of children treated, depending on the chemotherapy dose and duration. Annually, more than 10,000 children in the U.S. and Europe may receive this platinum-based chemotherapy. The potential market need is underscored by the fact that approximately 500,000 patients in the U.S. are diagnosed annually with cancers potentially treated with platinum-based chemotherapy.

Preserves hearing and improves quality of life for pediatric cancer patients

The value here is directly measured in preserved function. Data from the investigator-initiated Phase 2/3 STS-J01 clinical trial in Japan showed significant improvement in hearing preservation when PEDMARK® was added to cisplatin treatment. The drug helps children avoid lifelong reliance on hearing aids. Here's the quick math on the hearing loss incidence reduction:

Assessment Criteria	Hearing Loss Rate with Cisplatin Alone (Historical)	Hearing Loss Rate with PEDMARK® + Cisplatin (STS-J01 Trial)
ASHA Criteria	56 percent to 63 percent	24 percent and 16 percent
Brock Grade Scaling	56 percent to 63 percent	24 percent and 16 percent

What this estimate hides is the profound impact on a child's development; also, the drug showed no interference with the chemotherapy's effectiveness, evidenced by an approximate 95 percent clinical response rate in that trial. Fennec Pharmaceuticals Inc. reported net product sales of $9.7 million for the second quarter of 2025 and $12.5M for the third quarter of 2025, showing growing adoption of this value.

Recommended by NCCN guidelines for AYA and pediatric patients

Clinical recognition solidifies the value proposition. The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Adolescent and Young Adult (AYA) Oncology to include PEDMARK®. Specifically, the recommendation for the AYA population carries a 2A endorsement. This level of guidance helps drive adoption in treatment protocols across the U.S.

Unique formulation in single-dose, ready-to-use vials

The physical delivery of the product is part of the value for the provider. PEDMARK® is supplied as a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials intended for intravenous use. This ready-to-use format simplifies administration in the complex oncology setting, which is crucial since the FDA has directed that PEDMARK® is not substitutable with other sodium thiosulfate products.

You can see the commercial traction building with the Q3 2025 revenue hitting $12.5M. Finance: draft 13-week cash view by Friday.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Customer Relationships

You're looking at how Fennec Pharmaceuticals Inc. builds and maintains its connections with the healthcare ecosystem supporting PEDMARK. It's not just about selling a drug; it's about supporting a complex care pathway to prevent ototoxicity (hearing loss) from cisplatin chemotherapy.

High-touch support via the Fennec HEARS™ patient program

Fennec Pharmaceuticals Inc. heavily relies on its revamped Fennec HEARS™ patient support program. This program is central to the customer relationship, ensuring a seamless, supportive experience for both healthcare providers (HCPs) and the Adolescent and Young Adult (AYA) cancer patients. The focus here is on improving adherence by removing friction points in the patient journey.

The program has seen positive momentum, specifically noting quarter-over-quarter growth in enrollment in the Fennec HEARS™ and Specialty Pharmacy Program as of the second quarter of 2025. This growth is directly tied to the program's enhanced offerings.

• Strengthened HCP and patient services.
• Expanded payer reimbursement support.
• Streamlined access to home nursing resources.

Direct engagement with oncologists and institutional pharmacy directors

The commercial strategy centers on deep engagement within key accounts. Fennec Pharmaceuticals Inc. has been executing a targeted sales strategy that has yielded measurable results in account acquisition and retention. This direct approach is what drives product adoption in both academic and community settings.

In the second quarter of 2025, the company achieved double digit new accounts, showing notable quarter-over-quarter growth across both large community practices and academic centers. This momentum is supported by the fact that PEDMARK has been added to the formulary of a large national oncology group, which includes numerous community-based oncology practices across the U.S. The AYA market, which Fennec Pharmaceuticals Inc. estimates at approximately 20,000 individuals between ages 15 and 39 annually, is a key target for this direct engagement.

The financial investment underpinning this direct engagement is substantial, with Selling and Marketing Expenses recorded at $4.4 million in the second quarter of 2025.

Dedicated payer reimbursement support and streamlined access

Access is a critical relationship component in specialty pharma. Fennec Pharmaceuticals Inc. has made expanded payer reimbursement support a key feature of its patient support offerings. This effort directly supports the treating physician and patient by simplifying the financial hurdles associated with accessing PEDMARK.

The company's focus on securing access is reflected in the overall commercial success, with Net Product Sales reaching $9.7 million in the second quarter of 2025, a 33% increase year-over-year. This growth is explicitly attributed to expanded focus and growth in the AYA population and the successful growth and retention of existing accounts.

Educational outreach to increase awareness of ototoxicity prevention

Building the relationship involves educating the broader care team on the unmet need for ototoxicity prevention. Fennec Pharmaceuticals Inc. has focused on increasing awareness of the need for PEDMARK by hosting multiple advisory boards with leading academic centers and participating in notable conferences. Furthermore, efforts are underway to educate beyond oncologists, involving ENTs, audiologists, nurses, and pharmacists.

A concrete example of this educational success is the inclusion of PEDMARK in the National Community Oncology Drug Administration's (NCODA) Positive Quality Intervention (PQI). This PQI provides clinical data and guidance to multidisciplinary oncology care teams on the use, administration, and timing of PEDMARK.

The effectiveness of the product itself, which underpins the educational message, is compelling. The Japan trial showed hearing loss rates of only 24% (ASHA criteria) and 16% (Brock grade) with PEDMARK, compared to historical cisplatin-only rates of 56% and 63%, respectively.

Building long-term adherence with existing accounts

The relationship is sustained through demonstrated value and execution, leading to account retention. The company highlights the successful growth and retention of existing accounts within the AYA population as a driver of its sequential net product sales growth of 10% in the second quarter of 2025 over the first quarter of 2025, where sales were $8.8 million.

This long-term view is supported by the company's patent protection for PEDMARK until 2039 in both the U.S. and internationally, providing a stable foundation for long-term relationships with prescribers and institutions.

Here's a quick look at the financial context supporting these commercial relationship efforts as of mid-2025:

Metric	Amount/Value (Latest Reported)	Period/Date
Net Product Sales	$9.7 million	Q2 2025
Selling and Marketing Expenses	$4.4 million	Q2 2025
General and Administrative Expenses	$7.0 million	Q2 2025
Cash and Cash Equivalents	$18.7 million	June 30, 2025
New Accounts Added	Double Digit	Q2 2025

Finance: draft 13-week cash view by Friday.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Channels

You're looking at how Fennec Pharmaceuticals Inc. gets PEDMARK® to the oncology centers that need it, and honestly, it's a focused, multi-pronged approach that's clearly gaining traction in 2025.

U.S. direct sales force targeting oncology centers

The core of the U.S. channel relies on a direct sales force that you can see reflected in the operating expenses. For the first quarter of 2025, Selling and Marketing Expenses were reported at $2.9 million, which then increased to $4.4 million in the second quarter of 2025, showing an intensification of field execution. This team uses a segmentation model and data-driven target lists to enhance field execution, which yielded measurable impact, driving the addition of multiple new accounts across both academic and community providers in Q1 2025. By Q2 2025, this resulted in double-digit new accounts.

This direct effort is clearly translating to sales, as the company achieved Q2 2025 Total Net Revenues of $9.7 million, up 33% over Q2 2024. The latest reported figure, Q3 2025 Net Product Sales, hit approximately $12.5 million.

Specialty pharmacy network for product fulfillment

Fennec Pharmaceuticals Inc. significantly strengthened its Fennec HEARS™ and Specialty Pharmacy Offering in 2025. This revamped patient support program is designed to smooth out the fulfillment process by offering:

• Strengthened HCP and patient services.
• Expanded payer reimbursement support.
• Streamlined access to home nursing resources.

The growth in enrollment in this program was noted in the second quarter of 2025, which is a key indicator of the channel's operational success in getting the product to the patient after the order is placed.

Licensing partner Norgine for Europe, U.K., Australia, and New Zealand

For ex-U.S. markets, the channel is managed through the exclusive licensing agreement with Norgine Pharmaceuticals Ltd.. This partnership has seen concrete commercial milestones achieved in 2025:

Territory/Event	Product Name	Date/Status in 2025
England and Wales	PEDMARQSI®	Commercial launch during the first quarter of 2025
Germany	PEDMARQSI®	Commercial launch in February 2025
Scotland	PEDMARQSI®	Scottish Medicines Consortium (SMC) acceptance announced in May 2025

The success in these launches is part of the global momentum, with management noting Norgine's ex-U.S. PEDMARQSI® launches as a key factor in the company's outlook.

Direct-to-provider ordering and institutional purchasing channels

The growth in the U.S. channel is explicitly tied to adoption within specific institutional settings. The commercial team's strategy drove growth in both large community practices and academic centers. One notable success in 2025 was the accelerated adoption across a major oncology provider network after they added PEDMARK® to its formulary. This indicates a successful institutional purchasing channel where formulary inclusion is a critical step for sustained volume.

The overall U.S. sales performance supports this, as net product sales for the first nine months of 2025 have already surpassed the total net product sales of $29.6 million for the entire 2024 fiscal year.

Medical science liaisons (MSLs) for clinical education

Clinical education is a key supporting channel, utilizing Medical Science Liaisons (MSLs) as part of the U.S. field force to educate the medical communities and patients about cisplatin-induced ototoxicity and the use of PEDMARK®. Furthermore, educational guidance is being disseminated through formal documents:

• NCODA PQI (Positive Quality Intervention) Issued for PEDMARK®.
• Aims to provide pharmacists, nurses, and oncologists with clinical data and guidance.
• Focuses on use, administration, and timing to prevent platinum-induced ototoxicity in pediatric patients and the AYA population.

This educational push supports the field force's direct engagement and helps drive the adoption mentioned in the community and academic centers.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Customer Segments

You're looking at the core groups Fennec Pharmaceuticals Inc. (FENC) targets with PEDMARK^®, the only FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity (CIO). The customer segments are defined by the patient population receiving the chemotherapy and the institutions/payers that facilitate and fund that care.

Pediatric cancer patients (1 month+) receiving cisplatin chemotherapy

This segment represents the initial, FDA-approved indication for PEDMARK^®. The patient pool is defined by localized, non-metastatic solid tumors requiring cisplatin. The risk of hearing loss in this group is substantial, historically ranging from 40% to 60% in pediatric cancer patients. You see the protective effect clearly in the data from the investigator-initiated trial in Japan, where hearing loss rates dropped to 16% (Brock grade) and 24% (ASHA criteria) when PEDMARK^® was used alongside cisplatin. The overall tumor response rate remained approximately 95%, confirming no interference with the chemotherapy's anti-cancer effects.

Adolescent and Young Adult (AYA) cancer patients on cisplatin regimens

This is a significant growth vector for Fennec Pharmaceuticals Inc., as noted by management. The AYA segment (ages 15-39) is a high-value target, with over 20,000 patients annually in the U.S. and Europe receiving cisplatin-based regimens. This market is estimated to represent a $200+ million addressable opportunity. The National Comprehensive Cancer Network (NCCN) gives PEDMARK^® a 2A endorsement for this population, signaling strong clinical guidance for adoption. Fennec Pharmaceuticals Inc. reported surpassing greater than 90% reimbursement for PEDMARK^® in the AYA population as of Q3 2024, which is crucial for access in this group, often treated in community settings.

Academic and large community oncology treatment centers

These centers are the primary points of care where cisplatin is administered and where prescribing decisions for supportive care are made. Fennec Pharmaceuticals Inc. has focused its commercial execution on Tier 1-5 accounts, which collectively account for over 60% of U.S. cisplatin prescriptions. The company's Q1 2025 results showed growth across both academic and community providers, with early wins cited at institutions like Tampa General Hospital, Rady Children's Hospital, and Huntsman Cancer Institute. The European launch of PEDMARQSI^®, handled by Norgine, also saw commercial availability in Germany in February 2025, and in the U.K. and Wales during Q1 2025.

Institutional payers and government healthcare programs (CMS)

Market acceptance and sales depend heavily on securing coverage and adequate reimbursement from these entities. The company has actively worked to strengthen its Fennec HEARS™ patient support program to include expanded payer reimbursement support. The success in the AYA segment is directly tied to payer coverage, as evidenced by the reported 90% reimbursement achievement in Q3 2024. Uncertainty related to third-party coverage and reimbursement is a noted risk in filings, making this segment critical for revenue realization. The company's strong gross profit margins, reported at 93%, suggest favorable unit economics once access is secured.

Oncologists and pediatric oncologists who defintely prescribe cisplatin

These are the prescribers whose behavior Fennec Pharmaceuticals Inc. seeks to influence through education and support programs like Fennec HEARS™. The total addressable population is large; approximately 500,000 patients annually in the U.S. are diagnosed with cancers that could be treated with a platinum-based chemotherapy. The target prescribers are those managing the high-volume cisplatin patients in the pediatric and AYA segments. The company's recent financial performance reflects engagement with these prescribers, with Q3 2025 net product sales reaching a record high of approximately $12.5 million, up from $7.0 million in Q3 2024, showing four consecutive quarters of double-digit growth.

Here's a quick look at the patient incidence and the demonstrated protective effect:

Patient Group / Metric	Relevant Number / Rate	Context / Data Source
Annual U.S. & Europe AYA Cisplatin Patients	20,000+	Patients aged 15-39 receiving cisplatin-based regimens.
Historical Pediatric Ototoxicity Rate (Cisplatin Alone)	56% (ASHA) / 63% (Brock)	Historical rates from pivotal Phase 3 trials (ACCL0431/SIOPEL 6).
Ototoxicity Rate with PEDMARK® (Japan Study)	16% (Brock) / 24% (ASHA)	Topline results from STS-J01 investigator-initiated trial.
Tumor Response Rate with PEDMARK®	Approx. 95%	Demonstrates no attenuation of cisplatin antitumor activity.
Q3 2025 Net Product Sales	Approx. $12.5 million	Highest quarterly net product sales in Fennec Pharmaceuticals Inc.'s history.

The commercial focus is clearly on driving adoption within these defined patient pathways, which is translating to financial results, with the company reporting its first profitable quarter from operations as of Q3 2025. The company's market capitalization was $296M as of November 18, 2025, with a stock price of $8.66.

Finance: draft 13-week cash view by Friday.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Cost Structure

You're looking at the expenses driving Fennec Pharmaceuticals Inc.'s commercial stage, especially as they push PEDMARK® adoption in the U.S. The cost structure is heavily weighted toward commercialization and maintaining the regulatory foundation for their product.

The primary cost drivers for Fennec Pharmaceuticals Inc. in the third quarter of 2025 reflect the ongoing investment required to support the U.S. launch and maintenance of PEDMARK®. Here's a snapshot of the key figures from the period ended September 30, 2025.

Cost Category	Q3 2025 Amount	Comparison Point (Q3 2024)
Selling and Marketing Expenses	$5.2 million	$4.6 million
General and Administrative (G&A) Expenses	$6.8 million	$6.1 million
Net Product Sales (Revenue Context)	$12.5 million	$7.0 million

That Selling and Marketing spend of $5.2 million in Q3 2025 shows the commitment to the U.S. launch; it was up from $4.4 million the prior quarter and $4.6 million year-over-year. That's where the money goes when you're building out a specialized commercial presence.

General and Administrative (G&A) costs were $6.8 million for the quarter. This line item bundles necessary overhead, including the costs associated with protecting and maintaining your intellectual property portfolio. What this estimate hides is the exact split between IP defense, routine overhead, and executive functions.

Manufacturing and Cost of Goods Sold (COGS) for PEDMARK are a direct cost against the $12.5 million in Q3 2025 net product sales. While the specific COGS number isn't broken out in the latest release, it's the variable cost directly tied to producing the drug that generated those sales. The company is focused on commercialization, so these costs scale with adoption.

Clinical development and regulatory maintenance costs are ongoing expenses necessary to support the product post-approval and explore new territories. You see this reflected in the overall operating expenses, even as the focus shifts to commercial execution. For instance, preliminary results from the investigator-initiated clinical trial (STS-J01) evaluating PEDMARK® in Japan are expected in the fourth quarter of 2025, which implies continued associated costs.

Personnel and compensation for the specialized commercial team are embedded within the Selling and Marketing and G&A figures. You can see how compensation components fluctuate:

• G&A expenses in Q1 2025 increased quarter-over-quarter primarily due to non-cash stock-based compensation.
• Looking back at fiscal 2023, non-cash expenses associated with equity remuneration increased by $1.4 million over 2022.
• Also in fiscal 2023, payroll and benefits related expenses rose by $1.1 million compared to 2022.
• The cash position as of September 30, 2025, stood at $21.9 million, which must cover these operating outlays.

Finance: draft 13-week cash view by Friday.

Fennec Pharmaceuticals Inc. (FENC) - Canvas Business Model: Revenue Streams

Fennec Pharmaceuticals Inc.'s revenue streams as of late 2025 are heavily anchored in the commercial success of its U.S. product, PEDMARK, supplemented by significant non-recurring and recurring income from its international partnership.

The primary driver for current operational revenue is the direct sale of the U.S. product, PEDMARK. You saw the latest quarterly performance:

• Net product sales of PEDMARK in the U.S. for Q3 2025 reached approximately $12.5 million.
• This Q3 2025 figure represented a 79% year-over-year growth for the quarter.

Looking at the cumulative performance for the year through the third quarter, the total net product sales were approximately $31.0 million for the first nine months of 2025. This total is derived from the reported quarterly sales:

• Q1 2025 Net Product Sales: approximately $8.8 million.
• Q2 2025 Net Product Sales: approximately $9.7 million.
• Q3 2025 Net Product Sales: approximately $12.5 million.

The second major component of the revenue stream comes from the exclusive licensing agreement with Norgine for PEDMARQSI in Europe, Australia, and New Zealand. This deal provides both immediate cash and future potential earnings.

The upfront and milestone payments structure is quite substantial:

Payment Type	Amount (EUR)	Amount (USD Equivalent)
Upfront Consideration	€40 million	$44 million or $43.6 million
Additional Milestones (Max)	Up to €210 million	Up to $229 million

Also, Fennec Pharmaceuticals Inc. is set to receive double-digit tiered royalties on PEDMARQSI net sales from Norgine in those licensed territories, with the tiers going up to the mid-twenties percent. This is recurring revenue tied directly to Norgine's commercial success in Europe, Australia, and New Zealand.

Finally, there is potential for future licensing revenue tied to ongoing clinical work outside the Norgine territories. Specifically, you're watching the results from Japan:

• Preliminary results from the investigator-initiated clinical trial (STS-J01) evaluating PEDMARK in Japan were expected in Q4 2025.

If those results are positive, it opens the door for potential future licensing revenue from new territories like Japan, which would represent another distinct revenue stream for Fennec Pharmaceuticals Inc.