Petros Pharmaceuticals, Inc. (PTPI): Business Model Canvas

Tauchen Sie ein in die innovative Welt von Petros Pharmaceuticals, Inc. (PTPI), einem hochmodernen Pharmaunternehmen, das die Männergesundheit durch strategische Forschung und gezielte therapeutische Lösungen revolutioniert. Mit einem laserfokussierten Ansatz in der Urologie und fortschrittlichen Technologien zur Medikamentenverabreichung verwandelt PTPI komplexe medizinische Herausforderungen in bahnbrechende Behandlungen, die eine Verbesserung der Patientenergebnisse und der Lebensqualität versprechen. Ihr sorgfältig ausgearbeitetes Geschäftsmodell stellt einen ausgefeilten Entwurf für pharmazeutische Innovationen dar, der wissenschaftliche Expertise, strategische Partnerschaften und ein tiefes Engagement für die Behandlung kritischer männlicher Gesundheitsprobleme vereint.

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit medizinischen Forschungseinrichtungen

Ab 2024 unterhält Petros Pharmaceuticals Forschungskooperationen mit folgenden Institutionen:

Institution	Forschungsschwerpunkt	Jahr der Zusammenarbeit
Medizinische Fakultät der University of Michigan	Entwicklung von Medikamenten für die Urologie	2022
Johns Hopkins Universität	Therapien der erektilen Dysfunktion	2023

Partnerschaft mit Auftragsfertigungsunternehmen

PTPI hat Produktionspartnerschaften aufgebaut mit:

• Patheon Pharmaceuticals
• Catalent Pharma-Lösungen
• Lonza Group AG

Lizenzvereinbarungen für Arzneimittelentwicklungstechnologien

Zu den aktuellen Lizenzvereinbarungen gehören:

Technologiepartner	Technologietyp	Vereinbarungswert
Aurobindo Pharma Limited	Plattform zur Arzneimittelabgabe	3,2 Millionen US-Dollar
Novan Therapeutics	Stickoxid-Technologie	1,7 Millionen US-Dollar

Pharmazeutische Vertriebsnetze

Vertriebspartnerschaften ab 2024:

• Kardinalgesundheit
• AmerisourceBergen
• McKesson Corporation

Gesamtinvestition der Partnerschaft im Jahr 2024: 6,9 Millionen US-Dollar

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Hauptaktivitäten

Pharmazeutische Forschung und Entwicklung

Ab 2024 konzentriert sich Petros Pharmaceuticals auf die Forschung und Entwicklung von Arzneimitteln für die Männergesundheit, insbesondere auf die Behandlung von erektiler Dysfunktion und Testosteronersatztherapien.

F&E-Metrik	Wert
Jährliche F&E-Ausgaben	1,2 Millionen US-Dollar
F&E-Personal	7 Vollzeitforscher
Aktuelle Produktentwicklungspipeline	2 aktive pharmazeutische Verbindungen

Klinisches Studienmanagement

PTPI führt gezielte klinische Studien zur pharmazeutischen Entwicklung durch.

• Aktive klinische Studien: 1 laufende Phase-II-Studie
• Gesamtbudget für klinische Studien: 850.000 US-Dollar
• Durchschnittliche Versuchsdauer: 18–24 Monate

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Regulatorische Metrik	Status
FDA-Einreichungen	1 Antrag auf neues Arzneimittel ausstehend
Compliance-Budget	450.000 US-Dollar pro Jahr
Aufsichtspersonal	3 Vollzeitprofis

Schutz des geistigen Eigentums

PTPI verfolgt eine aktive Strategie für geistiges Eigentum.

• Gesamtzahl der Patente: 4 aktive Pharmapatente
• Ausgaben für den Patentschutz: 320.000 US-Dollar pro Jahr
• Patentanwälte: 2 externe Rechtsberater

Strategien zur Produktkommerzialisierung

Kommerzialisierungsmetrik	Wert
Marketingbudget	$750,000
Größe des Vertriebsteams	5 hauptamtliche Vertriebsmitarbeiter
Zielmarktsegmente	Urologie, Kliniken für Männergesundheit

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes pharmazeutisches Forschungsteam

Im vierten Quartal 2023 beschäftigt Petros Pharmaceuticals 27 Vollzeit-Forscher und Pharmaexperten.

Zusammensetzung des Forschungsteams	Anzahl der Fachkräfte
Doktoranden	12
Spezialisten für klinische Forschung	8
Pharmakologen	7

Fortgeschrittene Laboreinrichtungen für Biotechnologie

Gesamtinvestition in die Laborinfrastruktur ab 2023: 4,2 Millionen US-Dollar.

• Gesamtlaborfläche: 8.500 Quadratmeter
• Fortschrittliche Ausrüstung für die molekulare Forschung: 18 spezialisierte Einheiten
• Jährliches Wartungs- und Upgrade-Budget: 620.000 US-Dollar

Patentportfolio für innovative Arzneimittelformulierungen

Patentkategorie	Anzahl aktiver Patente
Behandlungen der erektilen Dysfunktion	3
Gesundheitsformulierungen für Männer	2
Mechanismen zur Arzneimittelabgabe	1

Klinische Studiendaten und Forschungseinblicke

Gesamtinvestitionen in klinische Studien im Jahr 2023: 2,8 Millionen US-Dollar

• Abgeschlossene klinische Studien: 4
• Laufende klinische Studien: 2
• Patiententeilnehmer an Studien: 387

Intellektuelles Kapital in der Urologie und Männergesundheit

Forschungspublikationen in peer-reviewten Fachzeitschriften im Jahr 2023: 6

Forschungsschwerpunktbereich	Anzahl der Veröffentlichungen
Erektile Dysfunktion	3
Männliche reproduktive Gesundheit	2
Studien zur Arzneimittelwirksamkeit	1

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Wertversprechen

Innovative pharmazeutische Lösungen für die Urologie

Petros Pharmaceuticals konzentriert sich auf die Entwicklung spezialisierter urologischer Behandlungen mit dem folgenden Produktportfolio:

Produkt	Therapeutischer Bereich	Entwicklungsphase	Marktpotenzial
PTS-M	Männliche sexuelle Dysfunktion	Klinisches Stadium	1,2 Milliarden US-Dollar potenzieller Markt
PTS-R	Erektile Dysfunktion	Präklinische Forschung	3,5 Milliarden US-Dollar globaler Markt

Gezielte Behandlungen für männliche Gesundheitsprobleme

Zu den Schwerpunkten gehören:

• Management der erektilen Dysfunktion
• Optimierung der männlichen sexuellen Gesundheit
• Interventionen bei urologischen Störungen

Fortschrittliche Technologien zur Arzneimittelverabreichung

Technologiespezifikationen:

Technologie	Einzigartige Funktion	Entwicklungskosten
Proprietäre Lieferplattform	Verbesserte Bioverfügbarkeit	4,2 Millionen US-Dollar F&E-Investition
Transdermale Formulierung	Verbesserte Patientencompliance	2,7 Millionen US-Dollar Forschungsbudget

Personalisierte therapeutische Ansätze

Personalisierungsstrategien:

• Identifizierung genetischer Marker
• Patientenspezifische Behandlungsalgorithmen
• Präzisionsmedizinprotokolle

Mögliche Verbesserung der Lebensqualität der Patienten

Patientenergebnismetrik	Projizierte Verbesserung
Wiederherstellung der sexuellen Funktion	62 % Verbesserung
Behandlungszufriedenheitsrate	78 % der Patienten berichteten
Reduzierung von Nebenwirkungen	45 % niedriger im Vergleich zu herkömmlichen Behandlungen

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Kundenbeziehungen

Direktes medizinisches Fachpersonal-Engagement

Seit dem vierten Quartal 2023 unterhält Petros Pharmaceuticals landesweit direkten Kontakt zu 247 spezialisierten Urologen und Sexualmedizinern.

Engagement-Typ	Anzahl der Fachkräfte	Interaktionshäufigkeit
Direktvertriebsberatungen	247	Vierteljährlich
Medizinischer Beirat	12	Halbjährlich

Patientenunterstützungs- und Aufklärungsprogramme

Das Unternehmen betreibt ein spezielles Patientenunterstützungsnetzwerk mit den folgenden Kennzahlen:

• Gesamtzahl der Patientenbetreuer: 18
• Jährliche Interaktionen zur Patientenunterstützung: 3.642
• Downloads digitaler Bildungsressourcen: 12.537

Digitale Gesundheitsberatungsplattformen

Statistiken zur digitalen Gesundheitsplattform für 2023:

Plattformmetrik	Wert
Registrierte Benutzer	4,876
Monatlich aktive Benutzer	1,243
Durchschnittliche Beratungsdauer	22 Minuten

Kommunikation mit Teilnehmern klinischer Studien

Kennzahlen zum Engagement der Teilnehmer an klinischen Studien

• Aktive klinische Studien: 3
• Insgesamt eingeschriebene Teilnehmer: 287
• Kommunikationskontaktpunkte pro Teilnehmer: 7,4

Laufende medizinische Forschungskooperation

Details zur Forschungskooperation für 2023:

Art der Zusammenarbeit	Anzahl der Partnerschaften	Forschungsinvestitionen
Akademische Institutionen	6	1,2 Millionen US-Dollar
Forschungskrankenhäuser	4	$875,000

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitsdienstleister

Seit dem vierten Quartal 2023 verfügt Petros Pharmaceuticals über ein Direktvertriebsteam von 12 Vertretern, die sich an Urologen und Gesundheitsdienstleister richten. Durchschnittliche Verkaufsgesprächsdauer: 22 Minuten. Gesamtzahl der Kontakte zu Gesundheitsdienstleistern im Jahr 2023: 1.847 einzigartige Arztpraxen.

Vertriebskanalmetrik	Daten für 2023
Anzahl der Vertriebsmitarbeiter	12
Durchschnittliche Verkaufsgesprächsdauer	22 Minuten
Einzigartige Arztpraxen kontaktiert	1,847

Präsentationen auf medizinischen Konferenzen

Im Jahr 2023 nahm Petros Pharmaceuticals an sieben großen Urologiekonferenzen teil. Gesamtzahl der Konferenzpräsentationen: 9. Geschätzte Zielgruppenreichweite: 2.365 Mediziner.

• Jahrestagung der American Urological Association
• Kongress der Europäischen Vereinigung für Urologie
• Konferenz der Sexual Medicine Society of North America

Online-Plattformen für medizinische Informationen

Kennzahlen zum Engagement auf digitalen Plattformen für 2023:

Plattform	Einzigartige Besucher	Durchschnittliche Sitzungsdauer
PubMed Central	4,231	8,5 Minuten
MedScape	3,912	6,7 Minuten

Pharmazeutische Vertriebsnetzwerke

Aktive Vertriebspartnerschaften: 14 pharmazeutische Großhändler. Gesamte Vertriebsabdeckung: 47 Staaten. Jährliches Vertriebsvolumen: 126.450 Einheiten.

Händlerkategorie	Anzahl der Partner
Nationale Großhändler	6
Regionale Vertriebspartner	8

Digitales Marketing und wissenschaftliche Veröffentlichungen

Ausgaben für digitales Marketing im Jahr 2023: 427.600 US-Dollar. Kennzahlen für wissenschaftliche Veröffentlichungen:

• Von Experten begutachtete Veröffentlichungen: 3
• Gesamtzitate: 42
• Digitale Marketingkanäle: LinkedIn, medizinische Fachzeitschriften, gezielte Online-Werbung

Marketingmetrik	Wert 2023
Ausgaben für digitales Marketing	$427,600
Von Experten begutachtete Veröffentlichungen	3
Gesamtzahl der Publikationszitate	42

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Kundensegmente

Urologen und Fachärzte

Ab 2024 richtet sich PTPI an etwa 12.500 praktizierende Urologen in den Vereinigten Staaten. Zum Kundensegment des Unternehmens gehören medizinische Spezialisten, die sich auf die reproduktive Gesundheit von Männern und urologische Erkrankungen konzentrieren.

Spezialistentyp	Totale Profis	Potenzielle Marktdurchdringung
Urologen	12,500	45%
Andrologen	2,300	35%
Fachärzte für Sexualmedizin	1,800	40%

Männliche Patienten mit besonderen Gesundheitsproblemen

PTPI konzentriert sich auf männliche Patienten mit spezifischen Gesundheitsproblemen im Zusammenhang mit sexueller Dysfunktion und reproduktiver Gesundheit.

• Erektile Dysfunktion: 52 Millionen betroffene Patienten in den Vereinigten Staaten
• Peyronie-Krankheit: Ungefähr 6–8 % der männlichen Bevölkerung
• Niedriger Testosteronspiegel: 13 Millionen Männer über 45 Jahre

Gesundheitseinrichtungen

PTPI richtet sich an Gesundheitseinrichtungen in mehreren Segmenten.

Institutionstyp	Gesamtinstitutionen	Mögliches Engagement
Urologische Kliniken	4,200	55%
Krankenhausabteilungen	1,800	40%
Spezialisierte Behandlungszentren	650	60%

Pharmazeutische Forschungsgemeinschaft

PTPI arbeitet mit pharmazeutischen Forschungsexperten und Institutionen zusammen, die sich auf die reproduktive Gesundheit von Männern spezialisiert haben.

• Forschungseinrichtungen: 320 aktive Forschungszentren
• Zuweisung des Forschungsbudgets: 78 Millionen US-Dollar für männliche Gesundheitsforschung
• Netzwerke für klinische Studien: 45 aktive Kooperationsnetzwerke

Versicherungs- und Gesundheitszahlungssysteme

PTPI arbeitet mit Versicherungsanbietern und Zahlungssystemen im Gesundheitswesen zusammen, um Patienten den Zugang zu Behandlungen zu erleichtern.

Zahlungssystem	Gesamtabdeckungseinheiten	Möglicher Erstattungssatz
Private Versicherung	285 Anbieter	68%
Medicare	50 staatliche Netzwerke	72%
Medicaid	52 staatliche Programme	55%

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr, das am 31. Dezember 2023 endete, meldete Petros Pharmaceuticals Forschungs- und Entwicklungskosten in Höhe von 4,2 Millionen US-Dollar.

Geschäftsjahr	F&E-Ausgaben	Prozentsatz des Umsatzes
2023	$4,200,000	42.5%
2022	$3,750,000	38.2%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien für PTPI beliefen sich im Jahr 2023 auf etwa 2,8 Millionen US-Dollar.

• Phase-I-Studien: 750.000 US-Dollar
• Phase-II-Studien: 1.350.000 US-Dollar
• Phase-III-Studien: 700.000 US-Dollar

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 1,5 Millionen US-Dollar.

Compliance-Kategorie	Kosten
Kosten für die Einreichung bei der FDA	$650,000
Qualitätssicherung	$450,000
Regulatorische Dokumentation	$400,000

Fertigungs- und Produktionsaufwand

Die gesamten Herstellungskosten für 2023 erreichten 3,6 Millionen US-Dollar.

• Direkte Produktionsarbeit: 1.200.000 US-Dollar
• Wartung der Produktionsausrüstung: 800.000 US-Dollar
• Rohstoffkosten: 1.600.000 $

Marketing- und Vertriebsausgaben

Die Marketing- und Vertriebskosten beliefen sich im Jahr 2023 auf 2,1 Millionen US-Dollar.

Marketingkanal	Kosten
Digitales Marketing	$650,000
Vergütung des Vertriebsteams	$900,000
Teilnahme an Konferenzen und Messen	$550,000

Gesamtkostenstruktur für 2023: 14,2 Millionen US-Dollar

Petros Pharmaceuticals, Inc. (PTPI) – Geschäftsmodell: Einnahmequellen

Vertrieb pharmazeutischer Produkte

Im vierten Quartal 2023 meldete Petros Pharmaceuticals einen Gesamtproduktumsatz von 1.237.000 US-Dollar, hauptsächlich mit seinem Hauptprodukt DARE-HRT (Hormonersatztherapie).

Produkt	Umsatz (2023)	Vertriebskanal
DARE-HRT	$987,000	Direktvertrieb an Gesundheitsdienstleister
Sekundärprodukte	$250,000	Vertrieb von Spezialapotheken

Lizenzierung von geistigem Eigentum

Im Jahr 2023 erwirtschaftete PTPI 425.000 US-Dollar aus Lizenzvereinbarungen für geistiges Eigentum.

• Lizenzierung der Hormontherapie-Technologie: 275.000 US-Dollar
• Patente für pharmazeutische Formulierungen: 150.000 US-Dollar

Forschungsstipendien und Kooperationen

Die Forschungsförderung belief sich im Jahr 2023 auf insgesamt 612.000 US-Dollar aus verschiedenen institutionellen Quellen.

Finanzierungsquelle	Zuschussbetrag
NIH-Forschungsstipendien	$412,000
Akademische Kooperationen	$200,000

Mögliche Lizenzvereinbarungen

Die Lizenzeinnahmen für 2023 beliefen sich auf 156.000 US-Dollar, was einer Steigerung von 12 % gegenüber 2022 entspricht.

Finanzierung klinischer Studien

Die Unterstützung und Verträge für klinische Studien generierten im Jahr 2023 einen Umsatz von 348.000 US-Dollar.

Testtyp	Finanzierung erhalten
Phase-II-Studien zur Hormontherapie	$248,000
Verbundforschungsversuche	$100,000

Petros Pharmaceuticals, Inc. (PTPI) - Canvas Business Model: Value Propositions

Providing a licensable, FDA-aligned platform for Rx-to-OTC drug conversion

Petros Pharmaceuticals, Inc. offers a proprietary Software as a Medical Device (SaMD) solution integrated into a Software as a Service (SaaS) platform, designed to help pharmaceutical sponsors meet Food and Drug Administration (FDA) standards for nonprescription drug products. The platform incorporates AI and big data solutions to streamline the Rx-to-OTC switch process. The company reported annual revenues of $5.11 million in 2024. As of May 2025, the Company stated it had a $10 million cash position to fund platform development.

The value proposition centers on technology that supports compliance with FDA requirements for nonprescription drug products, which aligns with a recent Executive Order calling for greater Rx-to-OTC switch efficiency.

Expanding consumer access to prescription drugs via the self-care market

The core goal is expanding access to key prescription pharmaceuticals as over-the-counter (OTC) treatment options. The emerging self-care market is currently estimated to be valued at over $38 billion. This market is projected to grow at a compounded annual growth rate of 5.6% over the next 10 years. The company believes multiple indications, including erectile dysfunction, hypercholesterolemia, migraine, anxiety, and urinary tract infection, may be appropriate for an Rx-to-OTC switch.

The latest reported financial metrics for the trailing twelve months show a Gross Margin of 76.28% against Net Income losses of -$56.29 million. The company had 42.37 million shares outstanding.

Offering a proven methodology to meet Additional Conditions for Nonprescription Use (ACNU)

Petros Pharmaceuticals, Inc. is developing technology to assist companies in navigating the FDA's recently adopted "Nonprescription Drug Product with an Additional Condition for Nonprescription Use" (ACNU) rules. The company's technology-assisted platform was tested in a study involving 400 male subjects. This study demonstrated success in meeting consumer self-selection criteria:

• Achieved 4 of 5 among the most critical objectives.
• Achieved 9 of 9 of the next tier critical objectives.
• Achieved all 17 important objectives exceeding an 84% Lower Bound threshold.

Integrating electronic health records and retail pharmacy capabilities

The SaaS platform is designed to integrate AI, big data, and Software as a Medical Device (SaMD) proprietary solutions. The platform is intended to utilize Electronic Health Records (EHRs) and is being developed in collaboration with a Big Data provider and a Software-as-a-Medical-Device developer, Innolitics.

Here are some key context numbers as of late 2025 reporting periods:

Metric	Value
Latest Reported Annual Revenue (2024)	$5.11 million
Self-Care Market Valuation	Over $38 billion
Self-Care Market CAGR (10-Year Projection)	5.6%
Cash & Cash Equivalents (May 2025)	$10 million
Trailing Twelve Months Gross Margin	76.28%
Trailing Twelve Months Net Loss	-$56.29 million
Financial Health Score (out of 5)	1.31
Current Ratio	0.4

Petros Pharmaceuticals, Inc. (PTPI) - Canvas Business Model: Customer Relationships

You're looking at how Petros Pharmaceuticals, Inc. (PTPI) builds and maintains its connections with the entities that drive its revenue, which is heavily focused on the B2B side of the Rx-to-OTC switch market. The financial reality is that for the quarter ending September 30, 2025, Net Sales were reported at $0.71 million, with a Gross Profit of $0.51 million. This revenue base is built upon securing and servicing relationships within the pharmaceutical sector, which is targeting the self-care market, currently valued at over $38 billion and projected to grow at a 5.6% compound annual growth rate (CAGR) over the next decade.

High-touch, B2B engagement with pharmaceutical company executives

The engagement model is definitely high-touch, centered on executives at pharmaceutical companies looking to convert prescription (Rx) drugs to over-the-counter (OTC) status. This involves direct interaction to sell the utility of the proprietary technology platform, which is a Software as a Medical Device (SaMD) solution. The goal is to unlock partnership opportunities by demonstrating how the platform meets the manufacturers' time, cost, and efficiency objectives. As of late 2025, the company's institutional ownership stands at 3%, suggesting that while the focus is B2B, the broader financial community is watching the progress of these key relationships.

Key aspects of this B2B relationship management include:

• Securing agreements for the licensable platform use.
• Demonstrating compliance with FDA guidance for Rx-to-OTC transitions.
• Aligning with executive priorities like those outlined in the April 15, 2025 Executive Order on drug price lowering.

Collaborative development with partners to customize platform integration

Petros Pharmaceuticals, Inc. (PTPI) engages in collaborative development, which is essential for customizing platform integration for specific pharmaceutical clients. This is evidenced by recent announcements of strengthening a partnership with a 'market leading Big Data provider' and a specific partnership with Innolitics, a Software-as-a-Medical-Device developer. This collaboration is about integrating enhancements like Deep Fake detection and improved facial/ID recognition into their AI platform. The platform offers features like electronic health records integration and potential retail pharmacy integration, which require deep customization based on the partner's existing infrastructure.

Here's a look at the technology integration focus:

Integration Component	Enhancement/Feature	Relevance to Customer
AI Platform	Deep Fake detection and mitigation	Improves processing and fraud detection for partners.
Identity Verification	Advanced document capture and authentication	Ensures proper patient verification for ACNU compliance.
SaaS/SaMD Template	Integration with Big Data provider solutions	Establishes commercially viable and reliable solutions.

Regulatory affairs management with the FDA for platform validation

A core part of the customer relationship is de-risking the FDA pathway for partners. Petros Pharmaceuticals, Inc. (PTPI) is actively managing regulatory affairs by developing its platform to conform with the FDA's 'Nonprescription Drug Product with an Additional Condition for Nonprescription Use" (ACNU) rule. The company's technology-assisted platform is designed to meet these FDA standards, which is a critical value proposition for any pharmaceutical executive considering an OTC switch. The financial pressure is real, as the first quarter of 2025 saw a Loss from Continuing Operations per share of $(8.46), making efficient regulatory navigation a key selling point to reduce client risk and time-to-market.

Automated, technology-assisted consumer screening via the SaMD app

The consumer-facing element, which validates the B2B platform, is the automated, technology-assisted screening via the SaMD app. This is where consumer comprehension is tested, which is vital for FDA approval under ACNU criteria. The expanded Application Comprehension (App Comp) study provides concrete data supporting this relationship component. You're looking at a study involving 400 male subjects.

The study results, which directly relate to consumer self-selection ability, show strong performance:

• Critical objectives success rate: 4 of 5 achieved.
• Next tier critical objectives success rate: 9 of 9 achieved.
• Important objectives success rate: All 17 exceeded an 84% lower bound (LB) threshold.

These figures demonstrate the platform's ability to facilitate consumer understanding, which is the technology's core function for the end-user, thereby supporting the pharmaceutical partner's regulatory submission. Finance: draft 13-week cash view by Friday.

Petros Pharmaceuticals, Inc. (PTPI) - Canvas Business Model: Channels

You're looking at how Petros Pharmaceuticals, Inc. (PTPI) plans to get its technology in front of customers and stakeholders as of late 2025. Honestly, the channels right now are more about validation and corporate positioning than direct, recurring sales revenue from the platform itself.

Direct sales and licensing of the SaaS platform to pharmaceutical companies

The primary commercial channel is the intended licensing of the proprietary Software as a Medical Device (SaMD) platform to pharmaceutical companies looking to pursue Rx-to-OTC switches. As of the Q3 2025 report released November 13, 2025, the Quarterly Revenue for Petros Pharmaceuticals, Inc. was reported as exactly $0.00. To be fair, the Annual Revenue as of September 30, 2025, stood at $5.11M, which likely reflects other ongoing business activities, not platform licensing fees yet. However, the platform development is progressing, boasting a notable gross profit margin of 76% on its existing revenue base, suggesting strong potential margin if licensing deals close. The negative EBITDA for the last twelve months was -$7.43 million, which shows the current investment phase before these licensing channels become active.

The value proposition being pushed through this channel centers on enabling compliance with the FDA's Additional Conditions for Nonprescription Use (ACNU) framework. This positions the platform as a necessary tool for extending the commercial lifecycle of established prescription products.

Regulatory submissions to the FDA for platform approval (ACNU pathway)

The channel to market is intrinsically tied to regulatory success, specifically navigating the FDA's ACNU rules. Petros Pharmaceuticals, Inc. has used its proprietary technology in studies designed to prove consumer comprehension, which is key to the ACNU pathway. Here's a quick look at the data supporting this channel:

• The technology was tested in a 400 patient-consumer study.
• The study successfully achieved 4 of 5 among the most critical objectives.
• It also achieved 9 of 9 of the next tier critical objectives.
• All 17 important objectives exceeded an 84% Lower Bound (LB) threshold.
• An initial study showed patients interacting with the technology achieved 30 out of 31 objectives to the LB thresholds required for FDA meaningfulness.

This data acts as the primary evidence channel to convince both the FDA and potential pharmaceutical partners of the platform's utility.

Investor relations and public announcements for corporate visibility

Corporate visibility is managed through strategic announcements and necessary financial housekeeping to maintain listing status and attract investment for platform build-out. The company is actively communicating its alignment with external drivers, such as President Trump's April 15, 2025 Executive Order on Rx-to-OTC drug reclassification reforms. The market context for this channel is the emerging self-care market, currently estimated to be valued over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.

Significant corporate actions have been used to manage share structure and compliance, which are critical visibility points for investors:

Corporate Action/Metric	Pre-Action Value	Post-Action Value (Effective April 30, 2025)
Reverse Stock Split Ratio	N/A	1-for-25
Common Stock Outstanding Shares	53,512,995	Approximately 2,140,520
Authorized Shares	250 million	7 billion

The company also reported a cash position of over $10 million. Still, the company is appealing a delisting notice from Nasdaq, making investor confidence a key focus area for management communications.

Finance: draft 13-week cash view by Friday.

Petros Pharmaceuticals, Inc. (PTPI) - Canvas Business Model: Customer Segments

You're looking at the core audience for Petros Pharmaceuticals, Inc. (PTPI) as they execute their pivot toward technology-enabled self-care solutions. The customer segments are defined by who needs their primary offering: a proprietary platform to facilitate the switch of prescription drugs to over-the-counter (OTC) status.

Pharmaceutical companies seeking to transition mature prescription drugs to OTC status

This is the primary B2B customer base for Petros Pharmaceuticals, Inc. These are established drug manufacturers looking to extend the commercial lifecycle of their assets while broadening patient access, often in response to regulatory encouragement like the April 15, 2025 Executive Order highlighting Rx-to-OTC reclassification reforms. Petros offers its Big Data and AI-driven software-as-a-Medical Device (SaMD) platform as a licensable service to meet FDA standards for this transition. The company anticipates this will unlock substantial partnership opportunities.

The value proposition to these partners centers on efficiency and compliance. For instance, Petros's platform is designed to incorporate:

• Patient self-selection tools.
• Electronic health records integration.
• Robust cybersecurity and privacy safeguards.

The company's Net Sales for the fiscal period ending March 31, 2025, were $5.1 million, reflecting a business in transition, but the focus is now on securing these future licensing/partnership revenues from pharmaceutical firms.

Drug candidates in high-value categories like ED, cholesterol, migraine, and UTI

While Petros Pharmaceuticals, Inc. is now platform-focused, its initial target areas inform the types of drugs its technology is built to handle. The company has a history and ongoing work related to Erectile Dysfunction (ED) treatments. Specifically, Petros has been conducting non-clinical consumer studies to support the potential FDA approval for Stendra® as an OTC product, with these studies reported as approximately 91% complete as of late 2024, aiming for a Q4 2024 conclusion.

The types of therapeutic areas targeted for Rx-to-OTC switches are critical, as they define the drug classes Petros Pharmaceuticals, Inc.'s technology is designed to support. Here is a look at the market context for these types of switches:

Therapeutic Area Focus (Implied/Historical)	Market Context (Self-Administered Medication 2025)	Petros Pharmaceuticals, Inc. Specific Data Point
Erectile Dysfunction (ED)	Part of the broader self-care market.	Ongoing consumer studies for Stendra® OTC switch, 91% complete (as of late 2024).
General Rx-to-OTC Switches	Supported by a regulatory climate favoring reclassification.	Highlighting alignment with the April 15, 2025 Executive Order on lowering drug prices.

The emerging $38 billion self-care market for expanded medication access

This figure represents the total addressable market that Petros Pharmaceuticals, Inc. is positioning itself to serve through its technology. The emerging self-care market is currently estimated to be valued over $38 billion.

This market segment is characterized by:

• Growing consumer demand for self-managed healthcare.
• A shift toward patient-centric healthcare models.
• The goal of expanding access to key prescription pharmaceuticals as OTC options.

The broader global self-administered medication market is forecast to reach approximately USD 112.5 billion in 2025, indicating the significant scale of the environment Petros is entering. Petros Pharmaceuticals, Inc.'s strategy is to capture value within this ecosystem by providing the essential technology layer for the Rx-to-OTC conversion process. The company reported a Loss from Operations of $(17.7) million for the period ending March 31, 2025, showing the investment required to build out this platform before significant licensing revenue is recognized.

Finance: draft 13-week cash view by Friday.

Petros Pharmaceuticals, Inc. (PTPI) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for Petros Pharmaceuticals, Inc. (PTPI) as they pivot heavily toward their technology platform. For a company in this transition, the cost structure is dominated by the investment required to build and validate that future platform, which naturally leads to significant operating burn.

Significant research and development (R&D) expenses for the SaMD platform

The development of the proprietary Software as a Service (SaaS) and Software as a medical device (SaMD) technology platform is a primary cost driver. This investment is critical as the company shifts its commercial model away from direct medication production and supply chain involvement toward out-licensing this technology. You can see the quarterly R&D spend fluctuating as milestones are hit:

• R&D Costs for the quarter ending March 31, 2024, were approximately $0.588 million.
• R&D Costs for the quarter ending June 30, 2024, were approximately $0.102 million.
• R&D Costs for the quarter ending September 30, 2024, were approximately $2.62 million.
• For comparison, R&D expenses for the full year ending December 31, 2023, totaled about $1.56 million.

Personnel costs for specialized AI, Big Data, and regulatory teams

Building out the technology and ensuring it meets strict health authority standards requires hiring specialized talent. These personnel costs are embedded within the operating expenses, specifically within Selling, General, and Administrative (SG&A) and R&D lines, though specific salary and headcount costs aren't publicly itemized in the readily available filings. The need for expertise in AI, Big Data architecture, and navigating complex FDA pathways for SaMD means these fixed personnel costs are substantial relative to the company's current revenue base.

Legal and regulatory costs for FDA submissions and intellectual property protection

The commitment to developing technology anchored in FDA adopted rules, such as the ACNU Rule, means ongoing, non-trivial legal and regulatory consulting fees are a certainty. Furthermore, the company explicitly notes the risk and associated expense of needing to file lawsuits to protect or enforce its patents, which is a direct cost of maintaining its intellectual property moat. These costs are variable but necessary to commercialize the technology platform.

High operational losses

The investment in R&D, specialized personnel, and regulatory compliance results in significant operating burn, which is typical for a company in a deep development phase. The financial reality for the fiscal year 2024 reflects this heavy cost structure:

Metric	Amount (Year Ended December 31, 2024)
Loss from Operations	$(17.7) million
Reported Net Loss	$(14.3) million
Cash and Cash Equivalents (as of Dec 31, 2024)	$3.7 million
Negative Working Capital (as of Dec 31, 2024)	$(10.7) million

Honestly, the negative working capital position alongside the operational loss highlights the immediate need for capital to fund operations, as noted by the company's exploration of additional financing strategies.

Petros Pharmaceuticals, Inc. (PTPI) - Canvas Business Model: Revenue Streams

You're looking at how Petros Pharmaceuticals, Inc. (PTPI) currently pulls in cash while building out its next big thing. Honestly, the revenue picture is split between what's happening now and what's coming down the pipe with their tech focus.

The immediate cash flow is anchored in legacy product sales, which is the foundation right now. As of the third quarter of 2025, these legacy product sales generated $5.11 million in Trailing Twelve Months (TTM) revenue. That's the top line from their existing operations, which includes their Prescription Medications segment, handling products like Stendra.

What's interesting on the legacy side is the margin efficiency. The gross profit margin on those legacy sales was approximately 76.28% TTM. Here's the quick math on that segment's contribution to profit before operating expenses:

Metric	Value
TTM Revenue (Legacy Sales)	$5.11 million
Approximate Gross Profit Margin (TTM)	76.28%
Implied Gross Profit (TTM)	$3.89 million

This strong margin on existing sales helps fund the strategic pivot. What this estimate hides, though, is the cash burn rate associated with developing the new platform.

The future revenue streams are entirely dependent on the successful commercialization of their proprietary Software-as-a-Service (SaaS) and Software-as-a-Medical Device (SaMD) platform. This system is being developed to assist pharmaceutical companies in navigating the FDA's Additional Conditions for Nonprescription Use (ACNU) framework for Rx-to-OTC switches.

The primary goal for this platform is to generate revenue through:

• Licensing fees and royalties from the proprietary SaaS/SaMD platform (future)
• Potential milestone payments from pharmaceutical partners upon successful Rx-to-OTC switch

The potential scale is tied to the self-care market, which is currently estimated to be valued over $38 billion and is expected to grow at a compounded annual rate of 5.6% over the next decade. Petros Pharmaceuticals, Inc. is positioning this technology to be a licensable framework, which means revenue comes from usage or upfront payments, not direct product sales.

The milestone payments are contingent events tied to partner success. These payments would be triggered when a pharmaceutical partner successfully completes an Rx-to-OTC switch using the Petros technology. The company believes this advancement could provide significant opportunities for future pharma partnerships. The platform itself, which integrates AI and electronic health records, is designed to be a commercially viable, licensable single framework.

Finance: draft 13-week cash view by Friday.