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

Dans le paysage dynamique de l'innovation pharmaceutique, Apellis Pharmaceuticals apparaît comme une force pionnière, naviguant stratégiquement dans le monde complexe des traitements de maladies rares grâce à son modèle commercial méticuleusement conçu. En tirant parti de la technologie d'inhibition du complément de pointe et en se concentrant sur les thérapies révolutionnaires, Apellis redéfinit la médecine de précision, ciblant les besoins médicaux non satisfaits avec une approche sophistiquée qui pante la recherche scientifique, les partenariats stratégiques et les solutions de santé transformatrices. Leur toile commerciale unique révèle un récit convaincant de l'ambition scientifique, des prouesses technologiques et un engagement à aborder certaines des conditions médicales les plus difficiles auxquelles sont confrontés les patients aujourd'hui.

Apellis Pharmaceuticals, Inc. (APLS) - Modèle commercial: partenariats clés

Collaboration avec les institutions de recherche médicale pour les essais cliniques

Apellis Pharmaceuticals a établi des partenariats avec les institutions de recherche suivantes pour les essais cliniques:

Institution	Focus de recherche	Essais cliniques actifs
Hôpital général du Massachusetts	Recherche d'inhibiteur du complément	3 essais actifs à partir de 2024
Clinique de mayo	Thérapeutiques de maladies rares	2 essais actifs à partir de 2024
Centre médical de l'Université de Stanford	Troubles immunologiques	1 essai actif à partir de 2024

Partenariats stratégiques avec les réseaux de distribution pharmaceutique

Apellis a établi des partenariats de distribution avec:

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Couverture du réseau de distribution: 87% des établissements de santé américains En 2024.

Accords de licence avec des sociétés de biotechnologie

Entreprise partenaire	Type d'accord	Conditions financières
Novartis	Licence technologique de l'inhibiteur du complément	Paiement initial de 45 millions de dollars
Alexion Pharmaceuticals	Contrat de recherche collaboratif	Financement de recherche de 30 millions de dollars

Collaborations de recherche avec des centres médicaux universitaires

Collaborations académiques actuelles:

• École de médecine de Harvard
• Université Johns Hopkins
• Université de Pennsylvanie

Financement total de collaboration de recherche: 12,5 millions de dollars en 2024

Partenariats potentiels avec les entreprises de technologie de santé

Entreprise technologique	Zone de collaboration potentielle	Statut
Iqvia	Gestion des données des essais cliniques	Discussions en cours
Systèmes Veeva	Intégration de logiciels de recherche clinique	Évaluation préliminaire

Apellis Pharmaceuticals, Inc. (APLS) - Modèle d'entreprise: activités clés

Développer des thérapies inhibiteurs du complément

Apellis se concentre sur le développement de thérapies sur les inhibiteurs du complément avec des dépenses de R&D de 387,7 millions de dollars en 2022. Les principaux domaines d'intervention comprennent:

• Pegcetacoplan (empaveli) pour l'hémoglobinurie nocturne paroxystique (PNH)
• Plate-forme d'inhibiteur complémentaire APL-2
• Recherche de traitement des maladies rares

Catégorie de thérapie	Investissement (2022)	Étape de développement
Inhibiteurs du complément	387,7 millions de dollars	Essais cliniques avancés
Traitements de maladies rares	156,3 millions de dollars	Recherche en cours

Effectuer des recherches cliniques avancées et des essais

Les dépenses de recherche clinique ont atteint 254,6 millions de dollars en 2022, avec des essais en cours dans plusieurs domaines thérapeutiques.

• 7 programmes de développement clinique actifs
• 3 essais cliniques de phase 3 en cours
• 2 thérapies approuvées par la FDA

Développement et test de produits pharmaceutiques

Les investissements en développement de produits ont totalisé 214,5 millions de dollars en 2022.

Catégorie de produits	Coûts de développement	Focus de recherche
Inhibiteurs du complément	172,9 millions de dollars	Troubles immunologiques
Thérapies rares	41,6 millions de dollars	Protocoles de traitement spécialisés

Compliance réglementaire et processus de soumission de la FDA

Les dépenses de conformité réglementaire étaient de 42,3 millions de dollars en 2022.

• 2 nouvelles demandes de médicament (NDAS) soumises
• 1 désignation de thérapie révolutionnaire de la FDA
• Engagement réglementaire continu

Recherche continue dans les traitements de maladies rares

Investissement de recherche de maladies rares de 156,3 millions de dollars en 2022.

Domaine de recherche	Investissement	Conditions cibles
Troubles immunologiques rares	98,7 millions de dollars	PNH, atrophie géographique
Plates-formes thérapeutiques spécialisées	57,6 millions de dollars	Maladies médiées par le complément

Apellis Pharmaceuticals, Inc. (APLS) - Modèle commercial: Ressources clés

Talent scientifique et de recherche spécialisés

Au quatrième trimestre 2023, Apellis Pharmaceuticals a employé 438 employés à temps plein, avec environ 65% dédiés à la recherche et au développement.

Catégorie des employés	Nombre d'employés	Pourcentage
R&D Professionals	285	65%
Opérations cliniques	87	20%
Personnel administratif	66	15%

Plateformes de technologie de la technologie des compléments propriétaires

Apellis a développé Plate-forme technologique APL-2, un inhibiteur du complément ciblant diverses maladies rares et conditions inflammatoires.

• A développé trois produits de produit d'inhibiteur de complément distinct
• Axé sur la pegcetacoplan en tant que candidat thérapeutique primaire
• Technologie applicable à plusieurs indications cliniques

Installations de recherche et développement avancées

Siège situé à Waltham, Massachusetts, avec 45 000 pieds carrés de recherche et de laboratoire.

Emplacement de l'installation	En pieds carrés	Fonction primaire
Waltham, MA	45 000 pieds carrés	Recherche et développement

Portfolio de propriété intellectuelle importante

En décembre 2023, Apellis détenait 269 brevets mondiaux protégeant sa technologie d'inhibition du complément.

• 269 ​​brevets totaux dans le monde
• Protection des brevets s'étendant jusqu'en 2038-2040
• Couvre la pegcetacoplan et les technologies d'inhibition du complément connexes

Capital financier solide pour la recherche en cours

Données financières pour le quatrième trimestre 2023 et l'exercice 2023:

Métrique financière	Montant
Equivalents en espèces et en espèces	1,2 milliard de dollars
Dépenses de R&D (2023)	574,3 millions de dollars
Revenu total (2023)	387,6 ​​millions de dollars

Apellis Pharmaceuticals, Inc. (APLS) - Modèle d'entreprise: propositions de valeur

Thérapies innovantes ciblant les maladies rares et sévères

Apellis Pharmaceuticals se concentre sur le développement de thérapies pour les maladies médiées par le complément avec des détails spécifiques sur le pipeline de produits:

Produit	Cible de la maladie	Étape de développement	Valeur marchande potentielle
Peignetacoplan	Hémoglobinurie nocturne paroxystique (PNH)	Approuvé par la FDA	750 millions de dollars de revenus potentiels annuels
Peignetacoplan	Atrophie géographique	Approuvé par la FDA	Marché potentiel de 1,2 milliard de dollars

Traitements de percée potentielles pour les troubles médiés par le complément

Apellis a développé des approches thérapeutiques ciblées avec une concentration clinique spécifique:

• Plateforme de technologie d'inhibition du complément
• Ciblage de précision de la cascade du complément
• Traitements potentiels pour plusieurs maladies rares

Approche de la médecine de précision dans le développement thérapeutique

Investissement en recherche	Dépenses de R&D (2023)	Portefeuille de brevets
Recherche de médecine de précision	354,2 millions de dollars	42 brevets accordés

Répondre aux besoins médicaux non satisfaits dans des populations de patients spécifiques

Apellis cible des segments de patients rares spécifiques avec des besoins cliniques non satisfaits:

• Troubles hématologiques rares
• Conditions médiées par le complément ophtalmologique
• Maladies inflammatoires et auto-immunes

Solutions scientifiques avancées pour des conditions médicales complexes

Plate-forme technologique	Mécanisme unique	Programmes cliniques
Inhibition du complément	Inhibition ciblée de C3	7 programmes de développement clinique actifs

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

Engagement direct avec les professionnels de la santé

Apellis maintient l'engagement direct grâce à des représentants commerciaux spécialisés Ciblage:

Spécialité	Nombre de professionnels ciblés
Hématologues	425
Ophtalmologistes	612
Immunologues	287

Programmes de soutien aux patients et d'éducation

Apellis offre des services complets de soutien aux patients:

• Inscription du programme d'aide aux patients: 1 247 patients
• Services de consultation de médicaments gratuits: 876 interactions mensuelles
• Ressources éducatives numériques: 14 modules en ligne

Services de consultation médicale personnalisés

Métriques du service de consultation:

Type de service	Interactions mensuelles
Consultations en tête-à-tête	214
Consultations de télémédecine	387

Plateforme de santé numérique pour le suivi du traitement

Capacités de plate-forme numérique:

• Utilisateurs enregistrés actifs: 2 563
• Caractéristiques de surveillance du traitement en temps réel: 7
• Conformité à la confidentialité des données: certifié HIPAA

Canaux de communication de recherche collaborative

Infrastructure de communication de recherche:

Canal de communication	Nombre de participants actifs
Plateformes d'information sur les essais cliniques	612
Réseaux de collaboration de recherche	276

Apellis Pharmaceuticals, Inc. (APLS) - Modèle d'entreprise: canaux

Ventes directes vers des centres médicaux spécialisés

Apellis maintient une force de vente spécialisée ciblant 250 centres d'ophtalmologie clés et de traitement des maladies rares aux États-Unis. L'équipe de vente se concentre sur maladies rares à médiation du complément Avec une moyenne de 18 représentants des ventes directes engageant des professionnels de la santé.

Métriques du canal de vente	2023 données
Nombre de centres médicaux ciblés	250
Représentants des ventes directes	18
Durée moyenne des appels de vente	45 minutes

Réseaux de distribution pharmaceutique

Apellis utilise trois principaux partenaires de distribution pharmaceutique:

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Réseau de distribution	Pourcentage de couverture
Amerisourcebergen	42%
Santé cardinale	33%
McKesson Corporation	25%

Présentations de la conférence médicale

Apellis participe à 12 à 15 conférences médicales majeures chaque année, en mettant l'accent sur l'ophtalmologie et la recherche de maladies rares.

Type de conférence	Participation annuelle
Conférences en ophtalmologie	7
Symposiums de maladies rares	5
Conférences totales	12

Publications scientifiques en ligne

Apellis publie des recherches dans 8 à 10 revues à comité de lecture par an, en mettant l'accent sur les maladies médiées par le complément.

Plate-forme de marketing numérique et de réseautage professionnel

La stratégie d'engagement numérique comprend:

• LinkedIn Professional Network
• Sites Web de professionnels médicaux ciblés
• Webinaires spécialisés de soins de santé

Plate-forme numérique	Engagement mensuel
Liendin	35 000 professionnels de la santé
Webinaires spécialisés	4-6 mensuellement
Trafic de site Web professionnel	50 000 visiteurs uniques

Apellis Pharmaceuticals, Inc. (APLS) - Modèle d'entreprise: segments de clientèle

Populations de patients atteints de maladies rares

Apellis se concentre sur les patients atteints de maladies rares médiées par le complément:

• Patients paroxystiques de l'hémoglobinurie nocturne (PNH): environ 5 000 aux États-Unis
• Complément 3 patients de glomérulopathie (C3G): estimé 2 000 à 3 000
• Patients d'atrophie géographique (GA): environ 1 million aux États-Unis de plus de 55 ans

Spécialistes de l'hématologie

Type spécialisé	Nombre de clients potentiels	Pénétration du marché cible
Spécialistes d'hématologie aux États-Unis	1 200 spécialistes praticiens	75% d'engagement cible
Centres médicaux académiques	50 centres majeurs	90% de sensibilisation potentielle

Chercheurs en immunologie

Target Research Community Segments:

• Laboratoires de recherche du complément financé par les NIH: 87
• Institutions de recherche sur l'immunologie mondiale: 250
• Financement annuel de subvention de recherche: 42 millions de dollars en recherche liée au complément

Systèmes hospitaliers

Segment de l'hôpital	Nombre total	Centres de traitement potentiels d'apellis
Grands centres médicaux académiques	150	112 centres de traitement potentiels
Centres d'hématologie spécialisés	287	203 centres de traitement potentiels

Participants à l'essai clinique

Apellis Clinical Trial Engagement:

• Essais cliniques actifs: 12 études en cours
• Participants totaux d'essai cliniques (2023): 856 patients
• Taux de recrutement des participants d'essai de maladie rare: 68% de la population ciblée

Apellis Pharmaceuticals, Inc. (APLS) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Depuis 2023 Exercice, Apellis Pharmaceuticals a déclaré des dépenses de R&D de 619,7 millions de dollars. Les recherches de l'entreprise se concentrent principalement sur l'immunologie du complément et les traitements de maladies rares.

Année	Dépenses de R&D	Pourcentage du total des revenus
2022	537,4 millions de dollars	87.3%
2023	619,7 millions de dollars	91.2%

Coûts de gestion des essais cliniques

Apellis a investi 276,3 millions de dollars dans les opérations d'essais cliniques au cours de 2023, couvrant plusieurs programmes de pipeline, notamment Pegcetacoplan et d'autres thérapies ciblées du complément.

• Essais de phase 3 pour l'atrophie géographique: 124,5 millions de dollars
• Essais paroxystiques de l'hémoglobinurie nocturne (PNH): 89,2 millions de dollars
• Recherche sur les maladies médiées par le complément: 62,6 millions de dollars

Investissements de conformité réglementaire

Les coûts de conformité réglementaire et d'assurance qualité pour 2023 ont totalisé 47,3 millions de dollars, ce qui représente les investissements critiques dans le maintien des normes de la FDA et de l'EMA.

Acquisition et rétention de talents

Le total des dépenses de personnel pour 2023 a atteint 263,4 millions de dollars, avec un ensemble moyen de rémunération de 215 000 $ par employé scientifique spécialisé.

Catégorie des employés	Nombre d'employés	Compensation totale
Chercheur	342	73,5 millions de dollars
Développement clinique	214	46,2 millions de dollars
Affaires réglementaires	87	18,7 millions de dollars

Équipement et technologie scientifiques avancés

Les investissements technologiques et d'équipement en 2023 s'élevaient à 92,6 millions de dollars, en se concentrant sur les plateformes avancées de recherche de recherche et de biologie informatique.

• Équipement de laboratoire: 42,3 millions de dollars
• Systèmes de recherche informatique: 33,7 millions de dollars
• Logiciel scientifique spécialisé: 16,6 millions de dollars

Apellis Pharmaceuticals, Inc. (APLS) - Modèle d'entreprise: Strots de revenus

Ventes potentielles de produits pharmaceutiques

Au troisième trimestre 2023, Apellis a déclaré un chiffre d'affaires total de 198,5 millions de dollars, principalement de Syfovre (Pegcetacoplan) pour l'atrophie géographique. Les revenus des produits en 2023 de l'année à l'année ont été projetés d'environ 770 millions de dollars à 810 millions de dollars.

Produit	Source de revenus	2023 Revenus estimés
Syfovre	Traitement d'atrophie géographique	770 $ - 810 millions de dollars

Subventions et financement de recherche

Au 31 décembre 2023, Apellis avait reçu un financement de recherche et des subventions totalisant 14,3 millions de dollars.

Licence de propriété intellectuelle

Apellis a plusieurs accords de licence, avec des paiements de jalons potentiels et des redevances de la propriété intellectuelle.

Partenaire	Type d'accord	Valeur de jalon potentielle
Privilège	Licence IP	Jusqu'à 200 millions de dollars

Accords de partenariat stratégique

• Collaboration avec AstraZeneca pour la recherche sur les inhibiteurs du complément
• Stronce de revenus de partenariat potentiel du développement collaboratif

Future commercialisation des produits thérapeutiques

Apellis a plusieurs programmes de stade clinique avec des revenus potentiels de commercialisation future:

Zone thérapeutique	Produit candidat	Étape de développement
Hémoglobinurie nocturne paroxystique	Peignetacoplan	Phase 3
Troubles immunitaires	Plusieurs candidats	Préclinique / phase 1

Apellis Pharmaceuticals, Inc. (APLS) - Canvas Business Model: Value Propositions

The value propositions for Apellis Pharmaceuticals, Inc. (APLS) center on delivering first-in-class, C3-targeting therapies for serious, rare diseases, providing tangible clinical benefits where options were previously limited or non-existent.

SYFOVRE is positioned as the first and leading FDA-approved therapy for Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). Long-term data from the GALE extension study shows that continuous treatment with SYFOVRE delayed GA lesion growth by approximately 1.5 years when compared to a sham/projected sham control in patients with nonsubfoveal GA. Specifically, from baseline to Month 60, the every-other-month (EOM) dosing group showed a 27% reduction in GA lesion growth (p < 0.0001), while the monthly group showed a 31% reduction (p < 0.0001). As of the second quarter of 2025, SYFOVRE held 55% of new patient starts and exceeded 60% total market share. The global population affected by GA is estimated to be more than one million Americans and five million people worldwide.

EMPAVELI is the first C3-targeting therapy approved by the U.S. Food and Drug Administration (FDA) on July 28, 2025, for Paroxysmal Nocturnal Hemoglobinuria (PNH), and more recently for C3 Glomerulopathy (C3G) and primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) in patients aged 12 and older. For C3G and primary IC-MPGN, the Phase 3 VALIANT study demonstrated a statistically significant 68% reduction in proteinuria compared to placebo (p<0.0001). The diseases C3G and primary IC-MPGN are estimated to affect approximately 5,000 people in the United States and up to 8,000 in Europe.

The unique mechanism of both medicines is targeting C3, which is the central protein in the complement cascade, a part of the body's immune system. This targeted approach provides a treatment option for rare kidney diseases with high unmet need, where up to 50% of patients progress to end-stage kidney disease (ESKD) within five to 10 years of diagnosis without treatment. Furthermore, up to approximately 90% of patients who receive a kidney transplant for these conditions experience disease recurrence.

Apellis Pharmaceuticals, Inc. is seeing commercial traction, with U.S. net product sales reaching $178 million in the third quarter of 2025, comprising $151 million from SYFOVRE and $27 million from EMPAVELI. Following the C3G/IC-MPGN launch, the company received 152 new patient start forms for EMPAVELI in the first two months. The company reported cash and cash equivalents of $479.2 million as of September 30, 2025.

The flexible dosing schedule for SYFOVRE is a key feature, allowing administration once every 25 to 60 days into each affected eye. The standard dose is 15 mg (0.1 mL) of a 150 mg/mL solution per injection.

Here is a summary of key financial and statistical metrics as of late 2025:

Metric	Product/Area	Value (Late 2025 Data)
U.S. Net Product Sales (3Q 2025)	Total	$178 million
SYFOVRE U.S. Net Product Revenue (3Q 2025)	SYFOVRE	$151 million
EMPAVELI U.S. Net Product Revenue (3Q 2025)	EMPAVELI (C3G/IC-MPGN launch)	$27 million
Total Revenue (3Q 2025)	Total	$458.6 million
Earnings Per Share (3Q 2025)	EPS	$1.67
Cash and Cash Equivalents (Sep 30, 2025)	Balance Sheet	$479.2 million
SYFOVRE Market Share (2Q 2025)	Geographic Atrophy	Exceeding 60% total market share
GA Patient Population (U.S. Estimate)	Unmet Need	More than one million Americans
C3G/IC-MPGN Patient Population (U.S. Estimate)	Unmet Need	Approximately 5,000 people
EMPAVELI WAC (Annualized)	C3G/IC-MPGN Pricing	$505,000 per patient
SYFOVRE Lesion Growth Delay (vs Sham)	Efficacy (Post Hoc)	Approximately 1.5 years

The value proposition is also supported by the breadth of clinical experience:

• SYFOVRE dosing schedule flexibility: every 25 to 60 days.
• EMPAVELI VALIANT study size: 124 patients.
• C3G/IC-MPGN patients progressing to ESKD without treatment: up to 50% in 5-10 years.
• Post-transplant recurrence rate for C3G/IC-MPGN: up to 90%.

Apellis Pharmaceuticals, Inc. (APLS) - Canvas Business Model: Customer Relationships

You're managing a commercial-stage biopharma focused on rare diseases, so your customer relationships aren't just about sales; they're about intensive support for patients facing serious, often life-altering conditions. This means the relationship is high-touch, especially for a newly launched product like EMPAVELI in C3G and primary ICMPGN.

For the recent EMPAVELI launch in C3G and primary IC-MPGN, Apellis Pharmaceuticals, Inc. tracked early engagement closely. Through the end of September 2025, the company reported receiving 152 new patient start forms for EMPAVELI in these indications, covering the first two months post-approval. This initial metric is crucial for rare disease launches. Also, about 50 patients from the prior Expanded Access Program (EAP) were in the process of converting to commercial drug by the end of 2025. For the established PNH patient base, Apellis Pharmaceuticals, Inc. continues to see high patient compliance rates, holding steady at 97%.

Dedicated patient assistance programs are central to ensuring access, particularly given the complexity of rare disease treatment. Apellis Pharmaceuticals, Inc. manages this through the ApellisAssist program. For SYFOVRE, the Co-Pay Program is structured to assist commercially-insured patients by covering eligible co-pay and co-insurance costs, offering up to $25,000 in annual financial assistance, which can let eligible patients pay as little as $0 per treatment up to that limit. It's worth noting that the utilization of SYFOVRE free goods was elevated in Q3 2025, impacting revenue by approximately $15 million.

The direct engagement with specialized physicians-nephrologists for EMPAVELI and retina specialists for SYFOVRE-is vital for navigating access and driving adoption. The ApellisAssist team is actively working with prescribers to manage the expected prior authorization hurdles for EMPAVELI, aiming to minimize delays. Early feedback from the nephrology community regarding EMPAVELI has been described as enthusiastic, recognizing its compelling efficacy profile. For SYFOVRE, Apellis Pharmaceuticals, Inc. maintained market leadership in the geographic atrophy (GA) market, exceeding an estimated 60% total market share and capturing 52% of new patient starts during the third quarter of 2025. The company is also leveraging technology, like developing artificial intelligence tools, to enhance physician feedback and patient care.

Investor relationships are managed through transparent communication around commercial execution and financial health. The Q3 2025 earnings call provided concrete figures that underscore the commercial traction and financial stability. Here's a quick look at the numbers shared:

Metric	Q3 2025 Value	Context/Comparison
Total Revenue	$458.6 million	Up from $196.8 million in Q3 2024; included a $275.0 million upfront payment from Sobi.
Net Income	$215.7 million	Turnaround from a net loss of $57.4 million in Q3 2024.
Cash & Cash Equivalents	$479.2 million	As of September 30, 2025.
EMPAVELI U.S. Net Product Revenue	$27 million	Reflecting strong early launch in C3G/IC-MPGN and PNH compliance.
SYFOVRE U.S. Net Product Revenue	$150.9 million	Total SYFOVRE doses delivered were approximately 101K.
Operating Expenses	$235 million	Down from $244 million in the same quarter last year.

The relationship with the financial community is supported by clear metrics on product performance and market penetration. For the rare kidney disease segment, the addressable market for EMPAVELI (C3G and primary IC-MPGN) is estimated to include approximately 5,000 people in the United States. The company's ability to support patients through access hurdles is a key topic in these investor discussions, as is the ongoing development pipeline, which includes plans to initiate pivotal studies in FSGS and DGF by year-end 2025.

The support structure for EMPAVELI patients is comprehensive, involving dedicated personnel. When you enroll in ApellisAssist, you get a dedicated Apellis Care Educator (ACE), who has a nursing background, to provide 1-on-1 training on self-administration, either in-home or virtually. The ApellisAssist team is reachable at 1-866-MY-APL-ASSIST (1-866-692-7527), available 8 AM-8 PM ET, Monday-Friday. Also, they can connect you to a pharmacist 24 hours a day. The program also offers the Apellis Bridge Program to help cover temporary supply interruptions due to insurance changes.

For physicians specializing in these rare diseases, Apellis Pharmaceuticals, Inc. is focused on providing data that supports the value proposition. For instance, the 68% reduction in proteinuria seen in the VALIANT study for EMPAVELI is a key data point shared with nephrologists. The company is also focused on expanding the prescriber base for SYFOVRE through targeted educational initiatives and the planned introduction of a prefilled syringe. The sales force size, deemed sufficient for current targets, was noted to be between 50 to 60 persons as of early 2025.

Finance: draft the Q4 2025 patient assistance accrual estimate by next Tuesday.

Apellis Pharmaceuticals, Inc. (APLS) - Canvas Business Model: Channels

You're looking at how Apellis Pharmaceuticals, Inc. gets its two key products, SYFOVRE and EMPAVELI, into the hands of the right patients and providers as of late 2025. The channel strategy is clearly bifurcated between ophthalmology (SYFOVRE) and systemic rare diseases (EMPAVELI), with a distinct global partnership for ex-U.S. rights.

U.S. Direct Sales Force for SYFOVRE and EMPAVELI

While the exact headcount of the Apellis Pharmaceuticals, Inc. direct sales force isn't public, the channel effectiveness is measured by product uptake and delivery volume. For SYFOVRE, the channel successfully delivered approximately 94,000 SYFOVRE doses (commercial and sample vials) to physician practices in the fourth quarter of 2025. This indicates a substantial, trained field force supporting the ophthalmology segment. For EMPAVELI, the channel is measured by patient start forms following its mid-2025 approval for C3G and primary IC-MPGN. The company projects reaching 225 cumulative start forms or more by the end of 2025 for the new EMPAVELI indications.

Specialty Distributors and Pharmacies for Product Distribution

Distribution for systemic therapies like EMPAVELI often relies on a limited or exclusive specialty pharmacy network to manage cold chain requirements and REMS (Risk Evaluation and Mitigation Strategy) compliance. Historically, for pegcetacoplan (EMPAVELI), Apellis Pharmaceuticals, Inc. established a limited distribution arrangement. The initial specialty distribution partners included ASD Healthcare, Cardinal Health, McKesson Plasma & Biologics LLC, and McKesson Specialty Care Distribution LLC. PANTHERx Rare Specialty Pharmacy was also designated to dispense directly to patients. For SYFOVRE, the channel involves delivery directly to the treating physician offices, which also function as the dispensing point for the intravitreal injection.

Sobi's Commercial Network for Ex-U.S. Systemic Pegcetacoplan (Aspaveli)

Ex-U.S. commercialization for systemic pegcetacoplan, marketed as Aspaveli, is handled exclusively by Sobi. Sobi leverages its broad commercial footprint and deep rare disease expertise to reach patients globally, particularly for PNH, and following expected regulatory approvals for C3G and IC-MPGN. This partnership is financially significant for Apellis Pharmaceuticals, Inc., which received a $275 million upfront cash payment in July 2025 as part of a capped royalty purchase agreement, reducing its ex-U.S. royalty obligations to Sobi by 90% until defined caps are achieved.

Direct-to-Physician Delivery for SYFOVRE (Intravitreal Injection)

The channel for SYFOVRE is highly specialized, requiring direct delivery to the ophthalmology or retina specialist's office for the intravitreal injection procedure. This model ensures the product is available on-site for administration. In the third quarter of 2025, Apellis Pharmaceuticals, Inc. reported that SYFOVRE total injection demand grew 4% quarter-over-quarter. The volume of doses delivered reflects the channel's utilization: approximately 101,000 total doses were delivered in Q3 2025, with 86,000 being commercial vials. This direct-to-office channel supports SYFOVRE's market leadership, accounting for an estimated 52% of new patient starts in Q3 2025.

Key Channel Metrics and Financial Flows (Late 2025 Data)

Metric Category	Product/Channel	Value/Amount	Reporting Period/Context
U.S. Net Product Revenue	SYFOVRE	$151 million	Q3 2025
U.S. Net Product Revenue	EMPAVELI (Total)	$27 million	Q3 2025
SYFOVRE Doses Delivered	Commercial Vials	86,000	Q3 2025
SYFOVRE Market Share	New Patient Starts	52%	Q3 2025
EMPAVELI New Patient Starts	C3G/IC-MPGN Launch	152 forms	First two months post-launch in Q3 2025
Ex-U.S. Partnership Payment	Sobi Upfront Payment (Aspaveli)	$275 million	Received July 2025
Cash Position	Cash and Cash Equivalents	$479.2 million	As of September 30, 2025

The channel strategy for systemic products like EMPAVELI requires adherence to specific distribution agreements, which for the PNH indication involved a closed network of qualified pharmacies. For SYFOVRE, the channel is optimized for the in-office administration required for intravitreal injections.

The ex-U.S. channel relies entirely on Sobi's established infrastructure, which includes approximately 1,900 employees across Europe, North America, the Middle East, Asia, and Australia as of 2024.

• SYFOVRE is the leading treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
• EMPAVELI's new indications (C3G and primary IC-MPGN) expand its addressable market by approximately 5,000 patients.
• The direct-to-physician delivery model for SYFOVRE supports its market leadership position.
• The Sobi agreement provides Apellis Pharmaceuticals, Inc. with non-dilutive funding, strengthening the balance sheet to $479.2 million in cash as of September 30, 2025.

Finance: draft 13-week cash view by Friday.

Apellis Pharmaceuticals, Inc. (APLS) - Canvas Business Model: Customer Segments

You're looking at the core groups Apellis Pharmaceuticals, Inc. is targeting with its complement-inhibiting therapies. These segments are defined by the serious, often rare, diseases they suffer from, and the specialists who manage their care. Honestly, the company has successfully launched two distinct products across four serious indications, which is a major feat in biotech.

Geographic Atrophy (GA) patients secondary to AMD

This segment is served by SYFOVRE (pegcetacoplan injection). The addressable market in the U.S. is substantial, with an estimated 1 million people in the United States living with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). Apellis Pharmaceuticals, Inc. has established SYFOVRE as the market leader here. In the third quarter of 2025, SYFOVRE captured 52% of new patient starts and maintained a total market share exceeding an estimated 60%. Still, the penetration is relatively low; only about 10% of diagnosed GA patients are currently being treated with complement inhibitors. The U.S. net product revenue for SYFOVRE in Q3 2025 was $151 million.

Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

For PNH, the customer is the patient receiving EMPAVELI (pegcetacoplan). This segment shows high adherence, with patient compliance rates reported at 97%. The U.S. net product revenue generated from EMPAVELI for PNH in the first quarter of 2025 was $19.7 million.

Patients with rare kidney diseases: C3G and primary IC-MPGN

This is a newer, but critical, segment following the July 28, 2025, FDA approval of EMPAVELI for C3 Glomerulopathy (C3G) and primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) in patients aged 12 years and older. The estimated U.S. population for these two indications combined is around 5,000 people. The initial uptake is showing momentum; Apellis Pharmaceuticals, Inc. recorded 152 new patient start forms for EMPAVELI in C3G and primary IC-MPGN within the first two months post-launch (as of September 30, 2025). To be fair, the prognosis without treatment is grim, with roughly 50% of these patients progressing to kidney failure within five to 10 years. EMPAVELI U.S. net product revenue for Q3 2025, reflecting the early launch in these new indications and continued PNH use, was $27 million.

U.S. retina specialists, hematologists, and nephrologists

These are the key prescribers and gatekeepers for the respective patient populations. The prescribing community is segmented by specialty, directly correlating with the approved indications for Apellis Pharmaceuticals, Inc.'s products. You have retina specialists managing the GA patient base, hematologists for PNH, and nephrologists for the C3G and IC-MPGN patients. Physician adoption is driven by data; for instance, the nephrology community is responding to the positive Phase 3 VALIANT data published in The New England Journal of Medicine.

Here's a quick look at the patient populations and key metrics as of late 2025:

Indication	Product	U.S. Estimated Patient Population	Q3 2025 U.S. Net Product Revenue	Key Adoption/Compliance Metric
Geographic Atrophy (GA) secondary to AMD	SYFOVRE	~1 million people	$151 million	52% of new patient starts
Paroxysmal Nocturnal Hemoglobinuria (PNH)	EMPAVELI	Not specified	$27 million total EMPAVELI revenue in Q3 2025	97% patient compliance rate
C3G and Primary IC-MPGN	EMPAVELI	~5,000 people	Part of $27 million total EMPAVELI revenue in Q3 2025	152 new patient start forms by end of Q3 2025

The adoption landscape involves distinct prescribing behaviors. For GA, there's a noted 4% sequential growth in total injection demand in Q3 2025, though growth is expected to be steady near-term. For the kidney diseases, the initial focus is on converting those 152 start forms and managing the 4 to 6 week transition time from start form to actual treatment.

Finance: draft 13-week cash view by Friday.

Apellis Pharmaceuticals, Inc. (APLS) - Canvas Business Model: Cost Structure

You're looking at the core spending areas for Apellis Pharmaceuticals, Inc. as they scale up commercial operations and push their pipeline forward. The cost structure is heavily weighted toward supporting their marketed products and advancing late-stage clinical assets.

Research and Development (R&D) remains a substantial fixed cost, reflecting the commitment to innovation beyond the current approved indications. For the second quarter of 2025, Apellis Pharmaceuticals, Inc. reported R&D expenses of $67.0 million.

To support the commercial launch and ongoing market presence of SYFOVRE and EMPAVELI, Selling, General & Administrative (SG&A) costs are significant. In Q2 2025, SG&A expenses reached $131.1 million. This spending covers the necessary infrastructure for sales, marketing, and general corporate overhead.

The direct costs associated with manufacturing and delivering product are captured in the Cost of Sales. For the third quarter of 2025, Apellis Pharmaceuticals, Inc. reported Cost of Sales as $24.5 million.

A major component of the variable cost structure involves funding the pipeline expansion. This includes substantial outlay for clinical trials to support new indications for EMPAVELI and further development of other candidates. Apellis Pharmaceuticals, Inc. was on track to initiate pivotal trials for EMPAVELI in focal segmental glomerulosclerosis (FSGS) and in delayed graft function (DGF) in the second half of 2025.

Here's a quick look at how some of the key operating expenses trended between Q2 and Q3 2025:

Expense Category	Q2 2025 Amount	Q3 2025 Amount
Research & Development (R&D) Expenses	$67.0 million	$68.2 million
Selling, General & Administrative (SG&A) Expenses	$131.1 million	$142.7 million
Cost of Sales	$13.6 million	$24.5 million

The investment in the pipeline is clearly visible in the R&D spend, which also covers work on assets like APL-3007. These clinical trial costs are essential for expanding the total addressable market for Apellis Pharmaceuticals, Inc. The company is also investing in development activities such as a pre-filled syringe and AI imaging tools.

The overall operating expense profile for the third quarter of 2025 was $235 million.

You can see the ongoing investment in commercial scale-up reflected in the SG&A increases:

• SG&A in Q3 2025 was $142.7 million, up from $131.1 million in Q2 2025.
• The Q3 increase was driven by higher general commercial activities and personnel costs.
• R&D expenses for Q3 2025 were $68.2 million.
• Cost of Sales in Q3 2025 was $24.5 million.

Finance: draft 13-week cash view by Friday.

Apellis Pharmaceuticals, Inc. (APLS) - Canvas Business Model: Revenue Streams

You're looking at the core income drivers for Apellis Pharmaceuticals, Inc. as of late 2025, specifically focusing on the third quarter figures which show a significant impact from strategic partnership milestones. Honestly, the revenue mix in Q3 2025 is heavily weighted by a one-time event, so you need to separate that from the recurring product sales.

The primary revenue streams for Apellis Pharmaceuticals, Inc. are derived from the U.S. commercial sales of its two approved products, SYFOVRE and EMPAVELI, supplemented by significant non-product revenue from collaborations, most notably the one with Sobi.

Here are the key components of the revenue picture for the third quarter of 2025:

• SYFOVRE U.S. net product sales reached $151 million in Q3 2025.
• EMPAVELI U.S. net product sales were $27 million in Q3 2025.
• Total net product sales for the quarter were $177.8 million, comprised of $150.9 million from SYFOVRE and $26.8 million from EMPAVELI.
• The company reported that SYFOVRE total injection demand grew 4% quarter-over-quarter.
• EMPAVELI saw positive early launch momentum in C3G and primary IC-MPGN, recording 152 new patient start forms through September 30, 2025.

The non-product revenue stream was dominated by a major transaction with Sobi related to the ex-U.S. rights for Aspaveli (pegcetacoplan):

• Licensing and other revenue included a $275 million upfront payment from Sobi in Q3 2025, connected to the Aspaveli royalty purchase agreement.
• Total licensing and other revenue for the quarter was reported at $280.8 million, suggesting an additional $5.8 million in other associated revenue.
• Royalties and milestone payments from the Sobi collaboration (Aspaveli) are structured under this agreement, with the upfront payment being the most substantial component for the quarter.

To give you a clearer view of the total revenue generation for the period, here is a breakdown of the reported figures:

Revenue Component	Q3 2025 Amount (USD)
SYFOVRE U.S. Net Product Sales	$151 million
EMPAVELI U.S. Net Product Sales	$27 million
Total U.S. Net Product Sales	$177.8 million
Sobi Upfront Payment (Licensing)	$275.0 million
Other Licensing and Collaboration Revenue	$5.8 million
Total Reported Revenue	$458.6 million

The total revenue for the third quarter of 2025 was $458.6 million, which is a substantial increase from the $196.8 million reported in the third quarter of 2024. This large swing was almost entirely due to the one-time $275 million upfront payment. Finance: draft 13-week cash view by Friday.