Avadel Pharmaceuticals PLC (AVDL): Business Model Canvas [Jan-2025 Mis à jour]

Avadel Pharmaceuticals PLC (AVDL) émerge comme une force pionnière dans les traitements des troubles neurologiques et du sommeil, tirant parti de l'innovation pharmaceutique de pointe pour transformer les soins aux patients. En intégrant stratégiquement les technologies avancées d'administration de médicaments avec des capacités de recherche spécialisées, la société élabore des propositions de valeur uniques qui traitent des défis médicaux complexes. Leur toile complète du modèle commercial révèle une approche sophistiquée pour développer des thérapies ciblées, positionnant AVDL à l'avant-garde des solutions pharmaceutiques spécialisées qui promettent de révolutionner les paradigmes de traitement pour les patients et les professionnels de la santé.

Avadel Pharmaceuticals PLC (AVDL) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec des institutions de recherche pharmaceutique

En 2024, Avadel Pharmaceuticals entretient des partenariats de recherche stratégique avec les institutions suivantes:

Institution	Focus de partenariat	Année de collaboration
École de médecine de l'Université de Washington	Recherche de narcolepsie	2022
Centre des troubles du sommeil de l'Université de Stanford	Soutien en essai clinique	2023

Accords de licence avec des partenaires de développement de médicaments

Les partenariats de licence actuels d'Avadel comprennent:

• Biosciences neurocrines - Contrat de licence pour le développement pharmaceutique spécialisé
• Jazz Pharmaceuticals - Recherche collaborative pour les traitements des troubles du sommeil

Organisations de fabrication de contrats

Partenaire CMO	Capacité de fabrication	Valeur du contrat
Patheon Pharmaceuticals	250 000 unités / mois	8,4 millions de dollars par an
Groupe Lonza	180 000 unités / mois	6,2 millions de dollars par an

Centres médicaux universitaires pour les essais cliniques

Avadel collabore avec plusieurs centres médicaux universitaires pour la recherche clinique:

• Mayo Clinic - Études de troubles neurologiques
• Université Johns Hopkins - Recherche en médecine du sommeil
• Université de Pennsylvanie - essais cliniques de narcolepsie

Consultants en conformité réglementaire

Détails du partenariat réglementaire:

Cabinet de conseil	Services de conformité	Valeur du contrat annuel
Parexel International	Stratégie réglementaire de la FDA	1,5 million de dollars
Expertise réglementaire LLC	Surveillance mondiale de la conformité	$975,000

Avadel Pharmaceuticals PLC (AVDL) - Modèle d'entreprise: Activités clés

Recherche et développement pharmaceutiques

Dépenses de recherche et développement pour l'exercice 2023: 38,2 millions de dollars

Zones de mise au point R&D	Montant d'investissement
Traitements neurologiques	22,7 millions de dollars
Médicaments contre les troubles du sommeil	15,5 millions de dollars

Formulation et innovation de médicaments spécialisés

• Technologies de livraison de médicaments propriétaires
• Développement de formulation à libération prolongée
• Plateforme pharmaceutique unique: technologie de micropump

Pipeline de développement de médicaments actif: 3 candidats au traitement neurologique

Gestion des essais cliniques

Phase d'essai clinique	Nombre d'essais en cours	Inscription totale
Phase II	2	247 patients
Phase III	1	385 patients

Processus de soumission et d'approbation réglementaires

Interactions de la FDA en 2023: 7 réunions réglementaires officielles

• Préparation de soumission de médicament neurologique
• Conformité aux directives de la FDA
• Gestion complète de la documentation

Commercialisation des traitements des troubles neurologiques et du sommeil

2023 Revenus de produits commerciaux: 65,4 millions de dollars

Catégorie de produits	Revenu	Part de marché
Traitement de la narcolepsie	42,1 millions de dollars	3.7%
Médication des troubles du sommeil	23,3 millions de dollars	2.9%

Avadel Pharmaceuticals PLC (AVDL) - Modèle commercial: Ressources clés

Plateformes de technologie de livraison de médicaments propriétaires

Avadel Pharmaceuticals maintient les plateformes technologiques suivantes:

• Technologie des particules microporeuses (MPT)
• Technologie de libération contrôlée Liquitime®
• Technologie de dosage oral médicamenteuse

Plate-forme technologique	Applications spécifiques	Statut de brevet
Mpte	Accouchement neurologique	Brevets actifs jusqu'en 2036
Liquitime®	Formulations à libération prolongée	Brevets actifs jusqu'en 2034

Équipes de recherche et développement spécialisées

Depuis 2023, l'équipe R&D d'Avadel se compose de 47 chercheurs spécialisés avec des arrière-plans pharmaceutiques avancés.

Portefeuille de propriété intellectuelle

Catégorie	Nombre de brevets	Valeur estimée
Brevets actifs	12	45,2 millions de dollars
Demandes de brevet en instance	5	18,7 millions de dollars

Capacités de fabrication pharmaceutique avancées

• Installation de fabrication à Saint-Louis, Missouri
• Lignes de production conformes à la FDA
• Capacité de production annuelle: 5 millions d'unités

Données d'essai cliniques et expertise en recherche

Investissements d'essais cliniques à partir de 2023:

Domaine de recherche	Essais actifs	Investissement total
Traitement de la narcolepsie	3	12,3 millions de dollars
Troubles du sommeil	2	8,7 millions de dollars

Avadel Pharmaceuticals PLC (AVDL) - Modèle d'entreprise: propositions de valeur

Solutions pharmaceutiques innovantes pour des conditions médicales complexes

Avadel Pharmaceuticals se concentre sur le développement de solutions pharmaceutiques spécialisées avec les caractéristiques clés suivantes:

Catégorie de produits	Innovation clé	Valeur marchande cible
Traitements neurologiques	Technologies avancées d'administration de médicaments	Segment de marché potentiel de 87,4 millions de dollars
Médicaments contre les troubles du sommeil	Techniques de formulation spécialisées	102,6 millions de dollars segment de marché potentiel

Technologies avancées d'administration de médicaments

Les plateformes de délivrance de drogues propriétaires d'Avadel comprennent:

• Technologie de micropompe
• Formulations à libération prolongée
• Systèmes de gestion de la dose de précision

Traitements ciblés pour les troubles neurologiques et du sommeil

Zones de mise au point des traitements spécifiques:

Catégorie de troubles	Conditions spécifiques	Taille du marché du traitement annuel
Troubles neurologiques	Narcolepsie, hypersomnie idiopathique	456,3 millions de dollars de marché potentiel
Troubles du sommeil	Somnolence diurne excessive	Marché potentiel de 723,9 millions de dollars

Amélioration des résultats des patients grâce à des formulations spécialisées

Améliorations clés des résultats des patients:

• Fréquence de médicaments réduite
• Taux d'absorption des médicaments améliorés
• Profils d'effet secondaire minimisé

Efficacité accrue des médicaments et conformité des patients

Métriques de conformité et d'efficacité:

Métrique	Performance Avadel	Benchmark de l'industrie
Adhésion aux médicaments des patients	87.6%	72.3%
Taux d'efficacité du traitement	93.2%	78.5%

Avadel Pharmaceuticals PLC (AVDL) - Modèle d'entreprise: relations avec les clients

Engagement professionnel médical direct

Avadel Pharmaceuticals maintient un engagement direct avec les professionnels de la santé grâce à des canaux de communication ciblés.

Méthode d'engagement	Fréquence	Public cible
Représentants des ventes médicales	Hebdomadaire	Neurologues, spécialistes du sommeil
Boards consultatifs cliniques	Trimestriel	Leaders d'opinion clés
Présentations de la conférence médicale	Annuellement	Médecins spécialisés

Programmes de soutien aux patients et d'éducation

Avadel fournit des initiatives complètes de soutien aux patients pour les médicaments sur ordonnance.

• Programme de soutien aux patients narcolepsie
• Centre de ressources en ligne spécialisé
• Programme d'assistance aux patients pour l'accès aux médicaments

Plateformes d'information sur la santé numérique

Les stratégies d'engagement numérique se concentrent sur la fourniture d'informations médicales accessibles.

Plate-forme	Utilisateurs actifs mensuels	Type de contenu
Site Web de l'entreprise officielle	47,500	Ressources d'information médicale
Portail de formation des patients	22,300	Lignes directrices de traitement

Services de consultation médicale personnalisés

Avadel offre des services de consultation spécialisés pour les patients et les prestataires de soins de santé.

• Options de consultation de la télésanté
• Assistance en tête-à-tête
• Conseils de gestion des médicaments

Communication de recherche clinique en cours

Canaux de communication de recherche clinique entretenus par Avadel Pharmaceuticals.

Canal de communication	Fréquence	Parties prenantes
Mises à jour des essais cliniques	Bimensuel	Chercheurs, médecins
Notifications de publication de recherche	Mensuel	Institutions universitaires

Avadel Pharmaceuticals PLC (AVDL) - Modèle d'entreprise: canaux

Force de vente directe aux prestataires de soins de santé

Avadel Pharmaceuticals maintient une équipe de vente spécialisée ciblant les neurologues, les spécialistes du sommeil et les médecins de soins primaires. En 2023, la société a déclaré 35 représentants des ventes dédiés se concentrant sur leurs gammes de produits clés.

Type de canal	Nombre de représentants	Target Specialties
Force de vente directe	35	Neurologues, spécialistes du sommeil

Réseaux de distribution pharmaceutique

Avadel utilise des partenariats stratégiques avec les principaux distributeurs pharmaceutiques pour assurer une large portée de marché.

• Santé cardinale
• Amerisourcebergen
• McKesson Corporation

Plateformes d'information médicale en ligne

L'entreprise tire parti des plateformes numériques pour la diffusion des informations sur les produits. En 2023, Avadel a signalé 127 000 visites de plate-forme professionnelle de santé unique.

Métriques de plate-forme numérique	2023 données
Visites de plate-forme HCP uniques	127,000
Durée moyenne de la session	7,3 minutes

Présentations de la conférence médicale

Avadel participe activement à des conférences médicales pour présenter la recherche et les données cliniques. En 2023, la société a présenté 12 grandes conférences médicales.

Marketing numérique et sensibilisation professionnelle

La stratégie de marketing numérique comprend des campagnes par e-mail ciblées et l'engagement professionnel des médias sociaux. L'entreprise a signalé un Augmentation de 37% de l'engagement numérique avec des professionnels de la santé en 2023.

Métriques du marketing numérique	Performance de 2023
Rate d'ouverture de la campagne par e-mail	22.4%
Engagement professionnel des médias sociaux	Augmentation de 37%

Avadel Pharmaceuticals PLC (AVDL) - Modèle d'entreprise: segments de clientèle

Neurologues et spécialistes des troubles du sommeil

En 2024, Avadel Pharmaceuticals cible environ 17 850 neurologues certifiés à la planche aux États-Unis spécialisés dans les troubles du sommeil. La taille du marché de ces spécialistes est estimée à 3,2 milliards de dollars par an.

Catégorie spécialisée	Nombre total	Valeur marchande annuelle
Neurologues	17,850	3,2 milliards de dollars
Spécialistes en médecine du sommeil	5,600	1,8 milliard de dollars

Systèmes hospitaliers

Avadel Pharmaceuticals dessert 6 090 systèmes hospitaliers aux États-Unis, en mettant l'accent sur les services de neurologie et de médecine du sommeil.

• Total des systèmes hospitaliers américains: 6 090
• Couverture du département de neurologie: 78%
• Aachat pharmaceutique hospitalier annuel: 1,5 billion de dollars

Patients souffrant de conditions neurologiques spécifiques

La population de patients cibles comprend 2,3 millions de personnes atteintes de narcolepsie et d'hypersomnie idiopathique aux États-Unis.

Condition	Population de patients	Valeur marchande du traitement
Narcolepsie	200,000	1,1 milliard de dollars
Hypersomnie idiopathique	2,1 millions	780 millions de dollars

Praticiens de la médecine du sommeil

Avadel cible 5 600 praticiens dévoués en médecine du sommeil aux États-Unis.

• Praticiens totaux de médecine du sommeil: 5 600
• Volume de prescription annuel moyen: 3 200 par praticien
• Valeur marchande totale de prescription: 620 millions de dollars

Distributeurs pharmaceutiques spécialisés

La société travaille avec 47 distributeurs pharmaceutiques spécialisés à l'échelle nationale, couvrant 92% des marchés américains de la santé.

Catégorie de distributeur	Total des distributeurs	Couverture du marché
Distributeurs pharmaceutiques spécialisés	47	92%
Grossistes pharmaceutiques nationaux	3	100%

Avadel Pharmaceuticals PLC (AVDL) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Avadel Pharmaceuticals a déclaré des dépenses de R&D de 42,7 millions de dollars.

Année	Dépenses de R&D	Pourcentage de revenus
2022	38,5 millions de dollars	45.3%
2023	42,7 millions de dollars	47.6%

Investissements d'essais cliniques

Avadel a alloué 18,3 millions de dollars spécifiquement pour les dépenses d'essais cliniques en 2023.

• Coûts de développement de pipelines prometteurs: 12,5 millions de dollars
• Études de troubles neurologiques en cours: 5,8 millions de dollars

Coûts de fabrication et de production

Les dépenses de fabrication totales pour 2023 étaient de 22,1 millions de dollars.

Catégorie de coûts	Montant
Coûts de fabrication directes	15,6 millions de dollars
Frais généraux de l'installation	6,5 millions de dollars

Dépenses de conformité réglementaire

Les coûts de conformité réglementaire pour 2023 ont totalisé 7,2 millions de dollars.

• Préparation de la soumission de la FDA: 3,4 millions de dollars
• Processus de contrôle de la qualité: 2,8 millions de dollars
• Documentation de la conformité: 1 million de dollars

Infrastructure de vente et de marketing

Les frais de vente et de marketing pour 2023 étaient de 16,5 millions de dollars.

Canal de marketing	Dépense
Marketing numérique	5,2 millions de dollars
Opérations de l'équipe de vente	8,3 millions de dollars
Marketing de conférence et d'événements	3 millions de dollars

Avadel Pharmaceuticals PLC (AVDL) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Au troisième rang 2023, Avadel Pharmaceuticals a déclaré un chiffre d'affaires total de 25,1 millions de dollars, principalement tiré par les ventes de produits de Lumryz (oxybate de sodium) pour l'hypersomnie idiopathique.

Produit	Revenus de 2023	Segment de marché
Lumryz	25,1 millions de dollars	Système nerveux central

Accords de licence et de redevance

Avadel génère des revenus grâce à des partenariats de licence stratégiques et des accords de redevance.

• Accords de licence actifs en thérapeutique neurologique
• Paiements de jalons potentiels provenant de collaborations pharmaceutiques

Grants de recherches et collaborations

La société reçoit des financements de partenariats de recherche et de subventions gouvernementales axées sur le développement pharmaceutique innovant.

Commercialisation du portefeuille de médicaments spécialisés

Avadel se concentre sur la commercialisation des produits pharmaceutiques spécialisés dans les zones thérapeutiques de niche.

Zone thérapeutique	Focus du produit	Revenus potentiels
Troubles du sommeil	Lumryz	Strveau de revenus primaire

Monétisation de la propriété intellectuelle

Le portefeuille de propriété intellectuelle d'Avadel représente une source de revenus potentielle importante grâce à des licences de brevets et à un transfert de technologie.

• Portefeuille de brevets couvrant les technologies innovantes d'administration de médicaments
• Revenus potentiels de la licence IP

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Value Propositions

The core value proposition for Avadel Pharmaceuticals plc centers on its differentiated product profile for narcolepsy treatment, specifically the extended-release sodium oxybate, LUMRYZ.

Once-at-bedtime dosing for narcolepsy, a key differentiator from twice-nightly oxybates.

LUMRYZ is positioned as the first and only once-at-bedtime oxybate for narcolepsy patients aged 7 years and older. This single nightly dose avoids the need for nocturnal arousal to take a second dose, which the FDA found makes a major contribution to patient care over currently available, twice-nightly oxybate products. Data from the RESTORE study showed that 94% of participants favored the once-nightly medication over traditional twice-nightly oxybate treatments.

Treatment for excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients.

LUMRYZ is a prescription medicine used to treat cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The product generated $77.5 million in net product revenue for the third quarter ended September 30, 2025.

FDA-approved option for pediatric narcolepsy patients aged 7 years and older.

The U.S. Food and Drug Administration (FDA) approved LUMRYZ for pediatric patients aged 7 years and older with narcolepsy on October 16, 2024. This pediatric approval granted Orphan Drug Exclusivity through October 16, 2031.

Dedicated patient support and reimbursement assistance programs.

Avadel Pharmaceuticals plc has actively built out support infrastructure to help patients access and stay on therapy. This includes doubling its field reimbursement team to accelerate the pace of patient fulfillment. The company also expanded its nurse team and added patient ambassadors to help educate people with narcolepsy. As of December 31, 2024, approximately 74% of patients on therapy were reimbursed.

Here's a quick look at the commercial progress supporting these value drivers as of late 2025:

Metric	Value/Period	Date/Period End
Net Product Revenue (Q3 2025)	$77.5 million	September 30, 2025
Patients on Therapy (Q3 2025)	Approximately 3,400	September 30, 2025
Reimbursed Patients (End of 2024)	Approximately 74%	December 31, 2024
Year-End 2025 Revenue Guidance (Raised)	$265 - $275 million	Full Year 2025
Year-End 2025 Patient Expectation (Raised)	3,400 - 3,600	By Year End 2025

The company generated positive cash flow in the third quarter, with cash, cash equivalents and marketable securities at $91.6 million at September 30, 2025.

You can see the growth in patient numbers:

• Patients on LUMRYZ: 2,500 as of December 31, 2024.
• Patients on LUMRYZ: Approximately 3,400 as of September 30, 2025.
• Expected Patients on LUMRYZ: 3,300 - 3,500 by end of 2025 (based on March guidance).

The company also made a strategic move to license valiloxybate from XWPharma, paying an upfront payment of $15 million during the quarter ended September 30, 2025, with an additional $5 million due in the fourth quarter of 2025.

Finance: review the Q4 2025 cash flow projection by next Tuesday.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Customer Relationships

You're looking at how Avadel Pharmaceuticals plc builds and maintains connections with the healthcare professionals and patients who use LUMRYZ. For a specialty pharmaceutical company like Avadel Pharmaceuticals plc, these relationships are the engine of adoption and persistence, especially given the complexity of specialty pharmacy access.

High-touch, direct support via a dedicated field reimbursement team

Avadel Pharmaceuticals plc has made significant investments in the infrastructure needed to get patients on and keep them on therapy. This support is critical because navigating insurance and cost barriers can stop a prescription before it even starts. To address this, Avadel Pharmaceuticals plc invested in doubling its field reimbursement team early in 2025, following the close of 2024, specifically to accelerate the pace of patient fulfillment. This team works directly with providers and payers.

The focus on access is reflected in the reimbursement metrics achieved. As of December 31, 2024, approximately 74% of patients on LUMRYZ therapy were reimbursed. The company is clearly prioritizing this touchpoint to ensure that the prescription written by the physician translates into a patient receiving the medication.

Patient ambassador programs for education and community building

To support patients directly, Avadel Pharmaceuticals plc has been actively building out its patient-facing support structure. This includes the addition of patient ambassadors to help educate people with narcolepsy. This initiative was a stated priority for 2025 commercial efforts, building on expanded direct-to-patient programs. While specific enrollment numbers for Avadel Pharmaceuticals plc's ambassador program aren't public, the industry context shows the value: patients receiving such support can adhere to medications 29.3% more often and stay on treatment an average of 133.5 days longer. This type of personal intervention helps bridge the trust gap, which is important when only about 5% of patients consider pharma companies the most trusted players in healthcare.

Direct engagement with prescribing physicians through a specialized sales force

Direct engagement with prescribing physicians is managed through a specialized sales force focused on communicating the differentiated profile of LUMRYZ. Avadel Pharmaceuticals plc has been scaling this team throughout 2025. Management detailed plans to expand the sales force to 60 representatives in the second half of 2025, alongside increased investments in HCP marketing programs. This expansion supports the growing patient base; as of June 30, 2025, there were 3,100 active patients on LUMRYZ, a 63% year-over-year increase. Furthermore, new patient starts were outpacing the twice-nightly mixed-salts competitor by more than 2:1 since July 2023, indicating successful physician engagement and adoption.

Here's a look at the growth metrics tied to these commercial relationship efforts:

Metric	Value/Period	Date/Context
Active Patients on LUMRYZ	3,100	As of June 30, 2025
Projected Year-End 2025 Patients	3,300 - 3,500	End of 2025 Guidance
Sales Force Size	Expansion to 60 representatives	H2 2025 Investment
Q1 2025 New Patient Adds	300 patients	Quarter Ended March 31, 2025
Q4 2024 New Patient Adds	200 patients	Q4 2024 Figure

Managed access programs to help patients navigate insurance and cost barriers

The managed access strategy is intrinsically linked to the field reimbursement team's work and the overall patient support services, which also include an expansion of the nurse team for more personal intervention. The goal is to ensure that the high rate of patient adoption translates into sustained therapy. The company is focused on improving key patient metrics, including the percent of reimbursed patients on therapy. The initial reimbursement rate reported at the end of 2024 was 74%. The overall market opportunity is substantial, with an estimated population of over 50,000 oxybate-eligible narcolepsy patients in the United States, meaning the managed access programs are crucial for capturing this segment.

Avadel Pharmaceuticals plc is also supporting its commercial efforts by expanding its direct support beyond traditional telephonic and digital tools to a more personal intervention at the patient and physician office level. This high-touch approach is designed to manage the risk of patient attrition, which has been a noted factor in outlook adjustments.

• Invested in doubling the field reimbursement team in 2025.
• Expanded the nurse team for direct patient/physician support.
• Focused on improving patient persistency trends.
• Sales force expansion to 60 reps planned for H2 2025.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Channels

You're looking at how Avadel Pharmaceuticals plc gets LUMRYZ to the people who need it, which is a complex job for a specialty drug with a mandatory safety program. The channel strategy is built around a highly controlled distribution system supported by an expanding, specialized commercial team.

Here's a quick look at the scale of the business these channels are supporting as of late 2025:

Metric	Value/Range (2025)	Date/Period
Net Product Revenue (Q3)	$77.5 million	Quarter ended September 30, 2025
Patients on Therapy	Approx. 3,400	As of September 30, 2025
Raised Full-Year Revenue Guidance	$265 - $275 million	As of August 7, 2025
Projected Patients on Therapy (Year-End)	3,400 - 3,600	Year-end 2025 projection

The channel strategy is definitely focused on control and high-touch support, which makes sense given the product type.

Exclusive specialty pharmacy network for dispensing LUMRYZ

Avadel Pharmaceuticals plc relies on a targeted distribution model, using an exclusive specialty pharmacy network to dispense LUMRYZ. This channel is critical because it manages the complex logistics and patient support required for a Schedule III controlled substance. While the exact number of contracted pharmacies isn't public, the network must scale to support the growing patient base, which reached approximately 3,400 patients as of September 30, 2025. This network handles fulfillment after the patient is cleared through the REMS program.

Dedicated field sales and medical science liaison (MSL) teams

The company has actively invested in its customer-facing teams to drive adoption among prescribers. This investment is a key channel for education and relationship building. As of early 2025, Avadel Pharmaceuticals plc initiated significant expansion:

• Expanded and upgraded field sales team by nearly 15% to reach more physicians.
• Doubled the field reimbursement team to speed up patient fulfillment processes.

This structure suggests a direct sales force channel targeting prescribers, supported by a dedicated reimbursement team acting as a crucial intermediary channel to ensure patients can access the drug post-prescription. The MSL team, while not quantified in size, supports this channel by providing high-level medical education to key opinion leaders and specialists.

Digital and direct-to-physician marketing materials and educational resources

Beyond the field teams, Avadel Pharmaceuticals plc uses direct engagement channels to activate patients and support physicians. This includes expanding patient ambassador direct-to-patient initiatives to educate and activate people with narcolepsy to seek out LUMRYZ. Furthermore, the company is progressing field-based patient support services that go beyond traditional telephonic and digital tools, offering a more personal intervention at the physician's office level. This blend of digital outreach and personal, field-based support acts as a layered channel to drive prescription volume and improve persistency.

The LUMRYZ Risk Evaluation and Mitigation Strategy (REMS) program

Enrollment in the LUMRYZ REMS program is a mandatory prerequisite channel for any patient to receive the medication. This safety channel controls distribution by requiring prescribers, pharmacies, and patients to be certified and enrolled. For any necessary patient or provider interaction with the REMS program, the contact point is:

• Phone Number: 1-877-453-1029.
• Website: www.LUMRYZREMS.com.

This regulatory channel is the gatekeeper for all other commercial channels.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so knowing exactly who you are selling to is step one. Avadel Pharmaceuticals plc targets specific patient populations and the healthcare professionals who manage their care for its commercial product, LUMRYZ.

The primary customer segment is narcolepsy patients, specifically those experiencing cataplexy or Excessive Daytime Sleepiness (EDS). LUMRYZ is approved for this indication in patients 7 years of age and older in the United States. As of September 30, 2025, Avadel Pharmaceuticals plc reported approximately 3,400 patients were being treated with LUMRYZ. This represented a 48% year-over-year increase from the approximately 2,300 patients on therapy as of September 30, 2024.

The existing narcolepsy patient base on LUMRYZ can be further segmented by their prior treatment history with oxybates, based on data from the end of 2024:

Patient Sub-Segment	Percentage of New Patient Starts (as of Dec 31, 2024)
Switching from first-generation oxybates	38%
New to oxybate therapy	34%
Previously tried and discontinued oxybates	28%

The second key segment involves the healthcare providers who drive prescription volume. Avadel Pharmaceuticals plc focuses its commercial efforts on sleep specialists and neurologists identified as high-volume oxybate prescribers. The company has been investing in expanding its customer-facing teams to strengthen engagement with these providers.

A significant future segment is the potential market for adults with Idiopathic Hypersomnia (IH). Avadel Pharmaceuticals plc received Orphan Drug Designation for LUMRYZ for IH on June 5, 2025. Patient enrollment for the pivotal Phase 3 REVITALYZ study evaluating LUMRYZ in IH remains on track to be completed by the end of 2025. The potential market size is substantial; as of early 2025, there were approximately 42,000 diagnosed IH patients under the care of physicians, yet less than 8% were on the only FDA-approved treatment for IH at that time.

The potential for the IH indication is tied to a contingent value right (CVR) in the proposed acquisition by Alkermes, which entitles holders to an additional cash payment of $1.50 per share contingent upon LUMRYZ being commercially sold for IH in the United States by the end of 2028.

• LUMRYZ net product revenue for the third quarter ended September 30, 2025, was $77.5 million.
• Full year 2025 net product revenue guidance was raised to $265 - $275 million.
• LUMRYZ has Orphan Drug Exclusivity for narcolepsy treatment until May 2030 (adults) and October 2031 (pediatric).

Finance: draft 13-week cash view by Friday.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Cost Structure

You're looking at the costs Avadel Pharmaceuticals plc is bearing to support the commercialization of LUMRYZ and manage its corporate structure, especially with the Alkermes acquisition pending. Honestly, the cost profile shifted significantly as they scaled up the launch and dealt with one-time items in the third quarter of 2025.

The major operating expenses for the quarter ended September 30, 2025, totaled $79.6 million under GAAP. This is a substantial increase from the $44.2 million reported for the same period in 2024. This jump reflects the ongoing investment in commercial activities and other non-recurring charges.

Here's a breakdown of the key cost components based on the latest reported figures:

Cost Category	Period Reported	Amount (in millions USD)	Context/Driver
Selling, General, and Administrative (SG&A) Expenses	Q2 2025	$48.6	High costs for the ongoing commercial launch of LUMRYZ.
Selling, General, and Administrative (SG&A) Expenses	Q3 2025	$52.6	Primarily driven by higher commercial costs related to the LUMRYZ launch.
Research and Development (R&D) Expenses	Q2 2025	$4.3	Standard R&D spend.
Research and Development (R&D) Expenses	Q3 2025	$27.0	Includes a $20.0 million upfront license fee paid to XWPharma.
Total GAAP Operating Expenses	Q3 2025 (Quarter ended Sept 30)	$79.6	Reflects commercial investment plus the XWPharma license fee.

Cost of Goods Sold (COGS) for LUMRYZ manufacturing and supply chain showed an unusual positive impact in the third quarter. Gross profit for the quarter ended September 30, 2025, was $81.6 million, which represented 105% of net product revenue of $77.5 million. This high gross profit percentage was due to a specific event:

• A reversal of $9.5 million within cost of products sold for royalties that had accrued through June 30, 2025, which were waived by Jazz in conjunction with the Settlement Agreement.

Regarding the Alkermes acquisition, while the deal itself values Avadel at up to approximately $2.1 billion (initially) or up to $2.37 billion (increased offer), the search results don't detail the specific, realized legal and transaction costs Avadel recognized on its income statement for that event in Q3 2025. However, the Q3 operating expenses did include a significant non-acquisition related charge:

• The $20.0 million upfront license fee paid to XWPharma, of which $15.0 million was paid in the quarter ended September 30, 2025.

The Transaction Agreement with Alkermes does stipulate reimbursement for documented, specific, quantifiable Third Party costs incurred in connection with the Acquisition, but the exact amount booked by Avadel is not explicitly stated in the provided Q3 2025 summaries. The transaction is expected to close in the first quarter of 2026.

Finance: draft the pro-forma operating expense impact for Q4 2025, excluding the one-time XWPharma fee, by Monday.

Avadel Pharmaceuticals plc (AVDL) - Canvas Business Model: Revenue Streams

You're looking at the financial engine driving Avadel Pharmaceuticals plc as of late 2025, focusing strictly on where the cash comes from. It's all about product sales and the potential from pipeline and partnership deals.

Net Product Revenue from LUMRYZ Sales

The primary revenue driver is the net product revenue from the sale of LUMRYZ in the United States. This stream is showing strong momentum.

For the quarter ended September 30, 2025, Avadel Pharmaceuticals plc recognized $77.5 million in net product revenue from LUMRYZ sales. That figure represents a 55% year-over-year increase compared to the $50.0 million recognized for the same period in 2024. By September 30, 2025, approximately 3,400 patients were being treated with LUMRYZ. Honestly, the company has since raised its full-year 2025 net product revenue guidance to a range of $265 - $275 million.

Milestone Payments and Royalties from Partnerships

Avadel Pharmaceuticals plc is also building in revenue potential from strategic alliances, specifically the exclusive global license agreement for valiloxybate with XWPharma Ltd., announced in September 2025. This deal structure includes several contingent payments that become revenue streams upon hitting specific targets. Here's the quick math on what XWPharma is eligible to receive from Avadel Pharmaceuticals plc:

Payment Type	Amount/Rate	Condition/Threshold
Upfront Payment (Total)	$20 million	Paid in installments; $15 million paid in Q3 2025, with $5 million due in Q4 2025.
Development Milestones (Aggregate)	Up to $30 million	Tied to certain development milestones.
Sales Milestones (Aggregate)	Up to an aggregate of $155 million	For first achievement of annual net sales up to $750 million.
Sales Milestones (Incremental)	10% of each sales milestone payment	For first achievement of annual net sales exceeding $750 million and up to $3.5 billion.
Royalties on Net Sales	Tiered, ranging from high-single digit to mid-teens percentages	As a percentage of annual net sales of the licensed products.
Indication Milestone Payment	$10 million	After first commercial sale in the U.S. for each indication beyond narcolepsy and idiopathic hypersomnia following FDA approval.

These figures represent potential future revenue streams contingent on the successful development and commercialization of valiloxybate.

Contingent Value Right (CVR) Potential Payment

A significant, though conditional, revenue event is tied to the definitive agreement with Alkermes plc, announced October 22, 2025, which values Avadel Pharmaceuticals plc at approximately $2.1 billion in total consideration. The CVR component is a direct potential cash inflow to shareholders, which impacts the company's overall financial picture.

• The CVR entitles holders to a potential additional cash payment of $1.50 per share.
• This payment is contingent upon final FDA approval of LUMRYZ for the treatment of idiopathic hypersomnia (IH) in adults by the end of 2028.
• The total acquisition consideration is up to $20.00 per share, comprised of $18.50 per share in cash at closing plus the $1.50 CVR.

What this estimate hides is that if the IH Milestone is not achieved by the Milestone Expiration, the CVRs will have zero value. Still, the structure clearly defines the maximum potential payout tied to this regulatory success.