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

In der dynamischen Landschaft der pharmazeutischen Innovation erweist sich Apellis Pharmaceuticals als Vorreiter und navigiert mithilfe seines sorgfältig ausgearbeiteten Geschäftsmodells strategisch durch die komplexe Welt der Behandlung seltener Krankheiten. Durch den Einsatz modernster Komplementhemmungstechnologie und die Konzentration auf bahnbrechende Therapien definiert Apellis die Präzisionsmedizin neu und geht mit einem ausgefeilten Ansatz, der wissenschaftliche Forschung, strategische Partnerschaften und transformative Gesundheitslösungen verbindet, auf ungedeckte medizinische Bedürfnisse ein. Ihr einzigartiges Geschäftsmodell offenbart eine überzeugende Darstellung von wissenschaftlichem Ehrgeiz, technologischem Können und dem Engagement, einige der schwierigsten medizinischen Probleme anzugehen, mit denen Patienten heute konfrontiert sind.

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Wichtige Partnerschaften

Zusammenarbeit mit medizinischen Forschungseinrichtungen für klinische Studien

Apellis Pharmaceuticals hat Partnerschaften mit den folgenden Forschungseinrichtungen für klinische Studien aufgebaut:

Institution	Forschungsschwerpunkt	Aktive klinische Studien
Massachusetts General Hospital	Forschung zu Komplementinhibitoren	3 aktive Studien ab 2024
Mayo-Klinik	Therapeutika für seltene Krankheiten	2 aktive Studien ab 2024
Medizinisches Zentrum der Stanford University	Immunologische Störungen	1 aktive Testversion ab 2024

Strategische Partnerschaften mit pharmazeutischen Vertriebsnetzwerken

Apellis hat Vertriebspartnerschaften mit folgenden Unternehmen aufgebaut:

• AmerisourceBergen
• Kardinalgesundheit
• McKesson Corporation

Abdeckung des Vertriebsnetzes: 87 % der US-amerikanischen Gesundheitseinrichtungen ab 2024.

Lizenzverträge mit Biotechnologieunternehmen

Partnerunternehmen	Vereinbarungstyp	Finanzielle Bedingungen
Novartis	Lizenzierung der Komplementinhibitor-Technologie	Vorauszahlung in Höhe von 45 Millionen US-Dollar
Alexion Pharmaceuticals	Forschungskooperationsvereinbarung	30 Millionen US-Dollar Forschungsförderung

Forschungskooperationen mit akademischen medizinischen Zentren

Aktuelle akademische Forschungskooperationen:

• Harvard Medical School
• Johns Hopkins Universität
• Universität von Pennsylvania

Gesamtfinanzierung der Forschungskooperation: 12,5 Millionen US-Dollar im Jahr 2024

Potenzielle Partnerschaften mit Unternehmen der Gesundheitstechnologie

Technologieunternehmen	Möglicher Kooperationsbereich	Status
IQVIA	Datenmanagement für klinische Studien	Laufende Diskussionen
Veeva-Systeme	Integration von Software für die klinische Forschung	Vorläufige Bewertung

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Hauptaktivitäten

Entwicklung von Komplementinhibitor-Therapien

Apellis konzentriert sich auf die Entwicklung von Komplementinhibitor-Therapien und investiert im Jahr 2022 387,7 Millionen US-Dollar in Forschung und Entwicklung. Zu den Hauptschwerpunkten gehören:

• Pegcetacoplan (Empaveli) gegen paroxysmale nächtliche Hämoglobinurie (PNH)
• Plattform für APL-2-Komplementinhibitoren
• Forschung zur Behandlung seltener Krankheiten

Therapiekategorie	Investition (2022)	Entwicklungsphase
Komplementinhibitoren	387,7 Millionen US-Dollar	Fortgeschrittene klinische Studien
Behandlungen seltener Krankheiten	156,3 Millionen US-Dollar	Laufende Forschung

Durchführung fortgeschrittener klinischer Forschung und Studien

Die Ausgaben für klinische Forschung erreichten im Jahr 2022 254,6 Millionen US-Dollar, wobei Studien in mehreren Therapiegebieten laufen.

• 7 aktive klinische Entwicklungsprogramme
• 3 klinische Phase-3-Studien laufen
• 2 von der FDA zugelassene Therapien

Entwicklung und Prüfung pharmazeutischer Produkte

Die Investitionen in die Produktentwicklung beliefen sich im Jahr 2022 auf insgesamt 214,5 Millionen US-Dollar.

Produktkategorie	Entwicklungskosten	Forschungsschwerpunkt
Komplementinhibitoren	172,9 Millionen US-Dollar	Immunologische Störungen
Therapien für seltene Krankheiten	41,6 Millionen US-Dollar	Spezialisierte Behandlungsprotokolle

Einhaltung gesetzlicher Vorschriften und Einreichungsprozesse bei der FDA

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2022 auf 42,3 Millionen US-Dollar.

• 2 neue Arzneimittelanträge (NDAs) eingereicht
• 1 FDA-Auszeichnung für eine bahnbrechende Therapie
• Kontinuierliches regulatorisches Engagement

Kontinuierliche Forschung zur Behandlung seltener Krankheiten

Investitionen in die Erforschung seltener Krankheiten in Höhe von 156,3 Millionen US-Dollar im Jahr 2022.

Forschungsbereich	Investition	Zielbedingungen
Seltene immunologische Erkrankungen	98,7 Millionen US-Dollar	PNH, geografische Atrophie
Spezialisierte Therapieplattformen	57,6 Millionen US-Dollar	Komplementvermittelte Krankheiten

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes Wissenschafts- und Forschungstalent

Im vierten Quartal 2023 beschäftigte Apellis Pharmaceuticals 438 Vollzeitmitarbeiter, von denen etwa 65 % für Forschung und Entwicklung zuständig waren.

Mitarbeiterkategorie	Anzahl der Mitarbeiter	Prozentsatz
F&E-Experten	285	65%
Klinische Operationen	87	20%
Verwaltungspersonal	66	15%

Proprietäre Technologieplattformen zur Komplementhemmung

Apellis hat sich entwickelt APL-2-Technologieplattform, ein Komplementinhibitor, der auf verschiedene seltene Krankheiten und entzündliche Erkrankungen abzielt.

• Entwicklung von drei unterschiedlichen Produktkandidaten für Komplementinhibitoren
• Konzentriert sich auf Pegcetacoplan als primären therapeutischen Kandidaten
• Technologie anwendbar auf mehrere klinische Indikationen

Fortschrittliche Forschungs- und Entwicklungseinrichtungen

Hauptsitz in Waltham, Massachusetts, mit 45.000 Quadratmetern Forschungs- und Laborfläche.

Standort der Einrichtung	Quadratmeterzahl	Primäre Funktion
Waltham, MA	45.000 Quadratfuß	Forschung und Entwicklung

Bedeutendes Portfolio an geistigem Eigentum

Im Dezember 2023 hielt Apellis weltweit 269 Patente zum Schutz seiner Komplementhemmungstechnologie.

• Insgesamt 269 Patente weltweit
• Patentschutz bis 2038-2040
• Deckt Pegcetacoplan und verwandte Komplementhemmungstechnologien ab

Starkes Finanzkapital für laufende Forschung

Finanzdaten für das vierte Quartal 2023 und das Geschäftsjahr 2023:

Finanzkennzahl	Betrag
Zahlungsmittel und Zahlungsmitteläquivalente	1,2 Milliarden US-Dollar
F&E-Aufwendungen (2023)	574,3 Millionen US-Dollar
Gesamtumsatz (2023)	387,6 Millionen US-Dollar

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Wertversprechen

Innovative Therapien gegen seltene und schwere Krankheiten

Apellis Pharmaceuticals konzentriert sich auf die Entwicklung von Therapien für komplementvermittelte Krankheiten mit spezifischen Details zur Produktpipeline:

Produkt	Krankheitsziel	Entwicklungsphase	Potenzieller Marktwert
Pegcetacoplan	Paroxysmale nächtliche Hämoglobinurie (PNH)	FDA-zugelassen	750 Millionen US-Dollar potenzieller Jahresumsatz
Pegcetacoplan	Geografische Atrophie	FDA-zugelassen	1,2 Milliarden US-Dollar potenzieller Markt

Mögliche bahnbrechende Behandlungen für komplementvermittelte Störungen

Apellis hat gezielte Therapieansätze mit spezifischem klinischem Fokus entwickelt:

• Technologieplattform zur Komplementhemmung
• Präzises Targeting der Komplementkaskade
• Mögliche Behandlungen für mehrere seltene Krankheiten

Präzisionsmedizinischer Ansatz in der therapeutischen Entwicklung

Forschungsinvestitionen	F&E-Ausgaben (2023)	Patentportfolio
Präzisionsmedizinforschung	354,2 Millionen US-Dollar	42 erteilte Patente

Bewältigung ungedeckter medizinischer Bedürfnisse in bestimmten Patientengruppen

Apellis richtet sich an bestimmte Patientensegmente mit seltenen Krankheiten mit ungedecktem klinischen Bedarf:

• Seltene hämatologische Erkrankungen
• Ophthalmologische komplementvermittelte Erkrankungen
• Entzündliche und Autoimmunerkrankungen

Fortschrittliche wissenschaftliche Lösungen für komplexe medizinische Erkrankungen

Technologieplattform	Einzigartiger Mechanismus	Klinische Programme
Komplementhemmung	Gezielte C3-Hemmung	7 aktive klinische Entwicklungsprogramme

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Apellis pflegt einen direkten Kontakt über spezialisierte Vertriebsmitarbeiter, die auf Folgendes abzielen:

Spezialität	Anzahl der gezielten Fachkräfte
Hämatologen	425
Augenärzte	612
Immunologen	287

Patientenunterstützungs- und Aufklärungsprogramme

Apellis bietet umfassende Patientenunterstützungsdienste:

• Einschreibung in das Patientenhilfsprogramm: 1.247 Patienten
• Kostenlose Medikamentenberatung: 876 Interaktionen monatlich
• Digitale Bildungsressourcen: 14 Online-Module

Personalisierte medizinische Beratungsdienste

Metriken der Beratungsleistung:

Servicetyp	Monatliche Interaktionen
Persönliche ärztliche Beratung	214
Telemedizinische Beratungen	387

Digitale Gesundheitsplattform zur Behandlungsverfolgung

Funktionen der digitalen Plattform:

• Aktive registrierte Benutzer: 2.563
• Funktionen zur Behandlungsüberwachung in Echtzeit: 7
• Datenschutzkonformität: HIPAA-zertifiziert

Kollaborative Forschungskommunikationskanäle

Forschungskommunikationsinfrastruktur:

Kommunikationskanal	Anzahl der aktiven Teilnehmer
Informationsplattformen für klinische Studien	612
Forschungskooperationsnetzwerke	276

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Kanäle

Direktverkauf an spezialisierte medizinische Zentren

Apellis unterhält ein spezialisiertes Vertriebsteam, das 250 wichtige Zentren für Augenheilkunde und die Behandlung seltener Krankheiten in den Vereinigten Staaten betreut. Das Vertriebsteam konzentriert sich auf seltene komplementvermittelte Erkrankungen mit durchschnittlich 18 Direktvertriebsmitarbeitern, die medizinisches Fachpersonal engagieren.

Vertriebskanalmetriken	Daten für 2023
Anzahl der gezielten medizinischen Zentren	250
Direktvertriebsmitarbeiter	18
Durchschnittliche Verkaufsgesprächsdauer	45 Minuten

Pharmazeutische Vertriebsnetze

Apellis nutzt drei primäre Pharmavertriebspartner:

• AmerisourceBergen
• Kardinalgesundheit
• McKesson Corporation

Vertriebsnetz	Abdeckungsprozentsatz
AmerisourceBergen	42%
Kardinalgesundheit	33%
McKesson Corporation	25%

Präsentationen auf medizinischen Konferenzen

Apellis nimmt jährlich an 12 bis 15 großen medizinischen Konferenzen teil, wobei der Schwerpunkt auf Augenheilkunde und der Erforschung seltener Krankheiten liegt.

Konferenztyp	Jährliche Teilnahme
Konferenzen zur Augenheilkunde	7
Symposien zu seltenen Krankheiten	5
Gesamtzahl der Konferenzen	12

Wissenschaftliche Online-Veröffentlichungen

Apellis veröffentlicht jährlich Forschungsergebnisse in 8–10 Fachzeitschriften mit Schwerpunkt auf Komplement-vermittelten Erkrankungen.

Plattformen für digitales Marketing und professionelles Networking

Die digitale Engagement-Strategie umfasst:

• LinkedIn Professional Network
• Gezielte Websites für medizinisches Fachpersonal
• Spezialisierte Webinare im Gesundheitswesen

Digitale Plattform	Monatliches Engagement
LinkedIn	35.000 medizinische Fachkräfte
Spezialisierte Webinare	4-6 monatlich
Professioneller Website-Traffic	50.000 einzelne Besucher

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Kundensegmente

Patientenpopulationen mit seltenen Krankheiten

Apellis konzentriert sich auf Patienten mit seltenen komplementvermittelten Erkrankungen:

• Patienten mit paroxysmaler nächtlicher Hämoglobinurie (PNH): Ungefähr 5.000 in den Vereinigten Staaten
• Patienten mit Komplement-3-Glomerulopathie (C3G): Schätzungsweise 2.000–3.000 in den Vereinigten Staaten
• Patienten mit geografischer Atrophie (GA): Ungefähr 1 Million in den Vereinigten Staaten über 55 Jahre

Spezialisten für Hämatologie

Spezialistentyp	Anzahl potenzieller Kunden	Zielmarktdurchdringung
Hämatologie-Spezialisten in den USA	1.200 praktizierende Spezialisten	75 % Ziel-Engagement
Akademische medizinische Zentren	50 große Zentren	90 % potenzielle Reichweite

Immunologieforscher

Zielsegmente der Forschungsgemeinschaft:

• Vom NIH finanzierte ergänzende Forschungslabore: 87
• Globale Forschungseinrichtungen für Immunologie: 250
• Jährliche Forschungsstipendien: 42 Millionen US-Dollar für komplementbezogene Forschung

Krankenhaussysteme

Krankenhaussegment	Gesamtzahl	Potenzielle Apellis-Behandlungszentren
Große akademische medizinische Zentren	150	112 potenzielle Behandlungszentren
Spezialzentren für Hämatologie	287	203 potenzielle Behandlungszentren

Teilnehmer an klinischen Studien

Beteiligung an der klinischen Studie von Apellis:

• Aktive klinische Studien: 12 laufende Studien
• Gesamtteilnehmer an klinischen Studien (2023): 856 Patienten
• Rekrutierungsrate für Studienteilnehmer zu seltenen Krankheiten: 68 % der Zielgruppe

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Im Geschäftsjahr 2023 meldete Apellis Pharmaceuticals Forschungs- und Entwicklungskosten in Höhe von 619,7 Millionen US-Dollar. Die Forschung des Unternehmens konzentriert sich hauptsächlich auf die Komplementimmunologie und die Behandlung seltener Krankheiten.

Jahr	F&E-Ausgaben	Prozentsatz des Gesamtumsatzes
2022	537,4 Millionen US-Dollar	87.3%
2023	619,7 Millionen US-Dollar	91.2%

Kosten für das Management klinischer Studien

Apellis investierte im Jahr 2023 276,3 Millionen US-Dollar in den Betrieb klinischer Studien und deckte mehrere Pipeline-Programme ab, darunter Pegcetacoplan und andere auf Komplement ausgerichtete Therapien.

• Phase-3-Studien zur geografischen Atrophie: 124,5 Millionen US-Dollar
• Studien zur paroxysmalen nächtlichen Hämoglobinurie (PNH): 89,2 Millionen US-Dollar
• Forschung zu komplementvermittelten Krankheiten: 62,6 Millionen US-Dollar

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften und die Qualitätssicherung beliefen sich im Jahr 2023 auf insgesamt 47,3 Millionen US-Dollar und stellen wichtige Investitionen in die Aufrechterhaltung der FDA- und EMA-Standards dar.

Talentakquise und -bindung

Die gesamten Personalkosten beliefen sich im Jahr 2023 auf 263,4 Millionen US-Dollar, mit einem durchschnittlichen Vergütungspaket von 215.000 US-Dollar pro spezialisiertem wissenschaftlichem Mitarbeiter.

Mitarbeiterkategorie	Anzahl der Mitarbeiter	Gesamtvergütung
Forschungswissenschaftler	342	73,5 Millionen US-Dollar
Klinische Entwicklung	214	46,2 Millionen US-Dollar
Regulatorische Angelegenheiten	87	18,7 Millionen US-Dollar

Fortschrittliche wissenschaftliche Ausrüstung und Technologie

Die Investitionen in Technologie und Ausrüstung beliefen sich im Jahr 2023 auf 92,6 Millionen US-Dollar und konzentrierten sich auf fortschrittliche Forschungsinfrastruktur und Computational-Biology-Plattformen.

• Laborausrüstung: 42,3 Millionen US-Dollar
• Computergestützte Forschungssysteme: 33,7 Millionen US-Dollar
• Spezialisierte wissenschaftliche Software: 16,6 Millionen US-Dollar

Apellis Pharmaceuticals, Inc. (APLS) – Geschäftsmodell: Einnahmequellen

Potenzielle Verkäufe pharmazeutischer Produkte

Im dritten Quartal 2023 meldete Apellis einen Gesamtumsatz von 198,5 Millionen US-Dollar, hauptsächlich mit Syfovre (Pegcetacoplan) gegen geografische Atrophie. Der Produktumsatz für das Gesamtjahr 2023 wurde auf etwa 770 bis 810 Millionen US-Dollar prognostiziert.

Produkt	Einnahmequelle	Geschätzter Umsatz 2023
Syfovre	Behandlung der geografischen Atrophie	770–810 Millionen US-Dollar

Forschungsstipendien und Finanzierung

Bis zum 31. Dezember 2023 hatte Apellis Forschungsgelder und Zuschüsse in Höhe von insgesamt 14,3 Millionen US-Dollar erhalten.

Lizenzierung von geistigem Eigentum

Apellis verfügt über mehrere Lizenzvereinbarungen mit potenziellen Meilensteinzahlungen und Lizenzgebühren aus geistigem Eigentum.

Partner	Vereinbarungstyp	Potenzieller Meilensteinwert
Privigen	IP-Lizenzierung	Bis zu 200 Millionen US-Dollar

Strategische Partnerschaftsvereinbarungen

• Zusammenarbeit mit AstraZeneca zur Komplementinhibitorforschung
• Potenzielle Einnahmequellen für Partnerschaften aus der gemeinsamen Entwicklung

Zukünftige Kommerzialisierung therapeutischer Produkte

Apellis verfügt über mehrere Programme im klinischen Stadium mit potenziellen zukünftigen Vermarktungserlösen:

Therapeutischer Bereich	Produktkandidat	Entwicklungsphase
Paroxysmale nächtliche Hämoglobinurie	Pegcetacoplan	Phase 3
Immunerkrankungen	Mehrere Kandidaten	Präklinisch/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.