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Petros Pharmaceuticals, Inc. (PTPI): Business Model Canvas [Jan-2025 Mis à jour] |
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Petros Pharmaceuticals, Inc. (PTPI) Bundle
Plongez dans le monde innovant de Petros Pharmaceuticals, Inc. (PTPI), une entreprise pharmaceutique de pointe révolutionnant la santé des hommes grâce à la recherche stratégique et à des solutions thérapeutiques ciblées. Avec une approche axée sur le laser sur l'urologie et les technologies avancées d'administration de médicaments, PTPI transforme les défis médicaux complexes en traitements révolutionnaires qui promettent d'améliorer les résultats des patients et la qualité de vie. Leur modèle commercial méticuleusement conçu représente un plan sophistiqué pour l'innovation pharmaceutique, le mélange d'expertise scientifique, les partenariats stratégiques et un engagement profond à traiter des problèmes de santé masculins critiques.
Petros Pharmaceuticals, Inc. (PTPI) - Modèle commercial: partenariats clés
Collaboration stratégique avec les institutions de recherche médicale
En 2024, Petros Pharmaceuticals entretient des partenariats de recherche avec les institutions suivantes:
| Institution | Focus de recherche | Année de collaboration |
|---|---|---|
| École de médecine de l'Université du Michigan | Développement de médicaments en urologie | 2022 |
| Université Johns Hopkins | Thérapies de dysfonction érectile | 2023 |
Partenariat avec les organisations de fabrication contractuelles
PTPI a établi des partenariats de fabrication avec:
- Patheon Pharmaceuticals
- Solutions pharmatriques catalennes
- Lonza Group AG
Accords de licence pour les technologies de développement de médicaments
Les accords de licence actuels comprennent:
| Partenaire technologique | Type de technologie | Valeur de l'accord |
|---|---|---|
| Aurobindo Pharma Limited | Plate-forme de livraison de médicaments | 3,2 millions de dollars |
| Novan Therapeutics | Technologie d'oxyde nitrique | 1,7 million de dollars |
Réseaux de distribution pharmaceutique
Partenariats de distribution à partir de 2024:
- Santé cardinale
- Amerisourcebergen
- McKesson Corporation
Investissement total de partenariat en 2024: 6,9 millions de dollars
Petros Pharmaceuticals, Inc. (PTPI) - Modèle d'entreprise: Activités clés
Recherche et développement pharmaceutiques
Depuis 2024, Petros Pharmaceuticals se concentre sur la recherche et le développement dans les produits pharmaceutiques de la santé des hommes, ciblant spécifiquement les thérapies de dysfonction érectile et de remplacement de la testostérone.
| Métrique de R&D | Valeur |
|---|---|
| Dépenses annuelles de R&D | 1,2 million de dollars |
| Personnel de R&D | 7 chercheurs à temps plein |
| Pipeline de développement de produits actuel | 2 composés pharmaceutiques actifs |
Gestion des essais cliniques
Le PTPI mène des essais cliniques ciblés pour le développement pharmaceutique.
- Essais cliniques actifs: 1 essai de phase II en cours
- Budget total des essais cliniques: 850 000 $
- Durée moyenne de l'essai: 18-24 mois
Processus de conformité réglementaire et d'approbation des médicaments
| Métrique réglementaire | Statut |
|---|---|
| Soumissions de la FDA | 1 nouvelle demande de médicament en attente |
| Budget de conformité | 450 000 $ par an |
| Personnel réglementaire | 3 professionnels à temps plein |
Protection de la propriété intellectuelle
PTPI maintient une stratégie de propriété intellectuelle active.
- Brevets totaux: 4 brevets pharmaceutiques actifs
- Dépenses de protection des brevets: 320 000 $ par an
- Avocats des brevets: 2 consultants juridiques externes
Stratégies de commercialisation des produits
| Métrique de commercialisation | Valeur |
|---|---|
| Budget marketing | $750,000 |
| Taille de l'équipe de vente | 5 représentants des ventes à temps plein |
| Segments de marché cibles | Urologie, cliniques de santé masculines |
Petros Pharmaceuticals, Inc. (PTPI) - Modèle d'entreprise: Ressources clés
Équipe de recherche pharmaceutique spécialisée
Depuis le quatrième trimestre 2023, Petros Pharmaceuticals emploie 27 chercheurs à temps plein et experts pharmaceutiques.
| Composition de l'équipe de recherche | Nombre de professionnels |
|---|---|
| Chercheurs de doctorat | 12 |
| Spécialistes de la recherche clinique | 8 |
| Pharmacologues | 7 |
Installations avancées de laboratoire de biotechnologie
Investissement total d'infrastructures en laboratoire en 2023: 4,2 millions de dollars.
- Espace total de laboratoire: 8 500 pieds carrés
- Équipement de recherche moléculaire avancée: 18 unités spécialisées
- Budget de maintenance et de mise à niveau annuelle: 620 000 $
Portefeuille de brevets pour les formulations de médicaments innovantes
| Catégorie de brevet | Nombre de brevets actifs |
|---|---|
| Traitements de la dysfonction érectile | 3 |
| Formulations de santé des hommes | 2 |
| Mécanismes d'administration de médicament | 1 |
Données des essais cliniques et idées de recherche
Investissements totaux d'essais cliniques en 2023: 2,8 millions de dollars
- Essais cliniques terminés: 4
- Essais cliniques en cours: 2
- Patient participants aux essais: 387
Capital intellectuel en urologie et santé des hommes
Publications de recherche dans des revues à comité de lecture en 2023: 6
| Domaine de mise au point de recherche | Comptage de publication |
|---|---|
| Dysfonction érectile | 3 |
| Santé reproductive masculine | 2 |
| Études d'efficacité des médicaments | 1 |
Petros Pharmaceuticals, Inc. (PTPI) - Modèle d'entreprise: propositions de valeur
Solutions pharmaceutiques innovantes pour l'urologie
Petros Pharmaceuticals se concentre sur le développement de traitements urologiques spécialisés avec le portefeuille de produits suivant:
| Produit | Zone thérapeutique | Étape de développement | Potentiel de marché |
|---|---|---|---|
| Pts-m | Dysfonctionnement sexuel masculin | Étape clinique | Marché potentiel de 1,2 milliard de dollars |
| Pts-r | Dysfonction érectile | Recherche préclinique | Marché mondial de 3,5 milliards de dollars |
Traitements ciblés pour les problèmes de santé masculins
Les principaux domaines d'intérêt comprennent:
- Gestion de la dysfonction érectile
- Optimisation de la santé sexuelle masculine
- Interventions des troubles urologiques
Technologies avancées d'administration de médicaments
Spécifications technologiques:
| Technologie | Caractéristique unique | Coût de développement |
|---|---|---|
| Plate-forme de livraison propriétaire | Biodisponibilité améliorée | 4,2 millions de dollars d'investissement en R&D |
| Formulation transdermique | Amélioration de la conformité des patients | Budget de recherche de 2,7 millions de dollars |
Approches thérapeutiques personnalisées
Stratégies de personnalisation:
- Identification des marqueurs génétiques
- Algorithmes de traitement spécifiques au patient
- Protocoles de médecine de précision
Amélioration potentielle de la qualité de vie des patients
| Métrique des résultats du patient | Amélioration projetée |
|---|---|
| Récupération des fonctions sexuelles | Amélioration de 62% |
| Taux de satisfaction au traitement | 78% du patient signalé |
| Réduction de l'effet secondaire | 45% inférieur par rapport aux traitements traditionnels |
Petros Pharmaceuticals, Inc. (PTPI) - Modèle d'entreprise: relations avec les clients
Engagement professionnel médical direct
Depuis le quatrième trimestre 2023, Petros Pharmaceuticals maintient un engagement direct avec 247 urologues spécialisés et praticiens de la santé sexuelle à l'échelle nationale.
| Type d'engagement | Nombre de professionnels | Fréquence d'interaction |
|---|---|---|
| Consultations de vente directe | 247 | Trimestriel |
| Conseil consultatif médical | 12 | Bi-annuellement |
Programmes de soutien aux patients et d'éducation
La société exploite un réseau de soutien aux patients dédié avec les mesures suivantes:
- Représentants totaux de soutien aux patients: 18
- Interactions annuelles de soutien aux patients: 3 642
- Téléchargements de ressources éducatives numériques: 12 537
Plateformes de consultation en santé numérique
Statistiques de la plate-forme de santé numérique pour 2023:
| Métrique de la plate-forme | Valeur |
|---|---|
| Utilisateurs enregistrés | 4,876 |
| Utilisateurs actifs mensuels | 1,243 |
| Durée de consultation moyenne | 22 minutes |
Communication des participants à l'essai clinique
Métriques d'engagement des participants à l'essai clinique
- Essais cliniques actifs: 3
- Total des participants inscrits: 287
- Points de contact de la communication par participant: 7.4
Collaboration en cours de recherche médicale
Détails de la collaboration de recherche pour 2023:
| Type de collaboration | Nombre de partenariats | Investissement en recherche |
|---|---|---|
| Institutions universitaires | 6 | 1,2 million de dollars |
| Hôpitaux de recherche | 4 | $875,000 |
Petros Pharmaceuticals, Inc. (PTPI) - Modèle d'entreprise: canaux
Ventes directes aux prestataires de soins de santé
Depuis le quatrième trimestre 2023, Petros Pharmaceuticals maintient une équipe de vente directe de 12 représentants ciblant les spécialistes de l'urologie et les prestataires de soins de santé. Durée moyenne des appels de vente: 22 minutes. Total des contacts du fournisseur de soins de santé en 2023: 1 847 pratiques médicales uniques.
| Métrique du canal de vente | 2023 données |
|---|---|
| Nombre de représentants commerciaux | 12 |
| Durée moyenne des appels de vente | 22 minutes |
| Pratiques médicales uniques contactées | 1,847 |
Présentations de la conférence médicale
En 2023, Petros Pharmaceuticals a participé à 7 grandes conférences d'urologie. Présentations totales de la conférence: 9. RECHERCHE AUTERNÉ ESTIMÉ: 2 365 professionnels de la santé.
- Réunion annuelle de l'American Urological Association
- Congrès de l'Association européenne de l'urologie
- Conférence de la Société de médecine sexuelle d'Amérique du Nord
Plateformes d'information médicale en ligne
Métriques d'engagement de la plate-forme numérique pour 2023:
| Plate-forme | Visiteurs uniques | Durée moyenne de la session |
|---|---|---|
| PubMed Central | 4,231 | 8,5 minutes |
| Medscape | 3,912 | 6,7 minutes |
Réseaux de distributeurs pharmaceutiques
Partenariats de distribution active: 14 distributeurs pharmaceutiques en gros. Couverture de distribution totale: 47 États. Volume de distribution annuel: 126 450 unités.
| Catégorie de distributeur | Nombre de partenaires |
|---|---|
| Grossistes nationaux | 6 |
| Distributeurs régionaux | 8 |
Marketing numérique et publications scientifiques
Dépens de marketing numérique en 2023: 427 600 $. Métriques de publication scientifique:
- Publications évaluées par des pairs: 3
- Total des citations: 42
- Canaux de marketing numérique: LinkedIn, revues médicales, publicité en ligne ciblée
| Métrique marketing | Valeur 2023 |
|---|---|
| Dépenses de marketing numérique | $427,600 |
| Publications évaluées par des pairs | 3 |
| Citations de publication totale | 42 |
Petros Pharmaceuticals, Inc. (PTPI) - Modèle d'entreprise: segments de clientèle
Urologues et médecins spécialistes
En 2024, PTPI cible environ 12 500 urologues pratiquants aux États-Unis. Le segment des clients de l'entreprise comprend des médecins spécialistes axés sur la santé reproductive masculine et les conditions urologiques.
| Type spécialisé | Total des professionnels | Pénétration potentielle du marché |
|---|---|---|
| Urologues | 12,500 | 45% |
| Andrologists | 2,300 | 35% |
| Spécialistes de la médecine sexuelle | 1,800 | 40% |
Patients masculins souffrant de problèmes de santé spécifiques
Le PTPI se concentre sur les patients masculins souffrant de problèmes de santé spécifiques liés à la dysfonction sexuelle et à la santé reproductive.
- Dysfonction érectile: 52 millions de patients touchés aux États-Unis
- Maladie de Peyronie: environ 6 à 8% de la population masculine
- Faible testostérone: 13 millions d'hommes de plus de 45 ans
Institutions de soins de santé
PTPI cible les établissements de santé dans plusieurs segments.
| Type d'institution | Total des institutions | Engagement potentiel |
|---|---|---|
| Cliniques d'urologie | 4,200 | 55% |
| Départements hospitaliers | 1,800 | 40% |
| Centres de traitement spécialisés | 650 | 60% |
Communauté de recherche pharmaceutique
PTPI s'engage avec des professionnels et des institutions de la recherche pharmaceutique spécialisés dans la santé reproductive masculine.
- Institutions de recherche: 320 centres de recherche actifs
- Attribution du budget de la recherche: 78 millions de dollars en recherche sur la santé masculine
- Réseaux d'essais cliniques: 45 réseaux collaboratifs actifs
Systèmes de paiement d'assurance et de santé
PTPI interface avec les fournisseurs d'assurance et les systèmes de paiement des soins de santé pour faciliter l'accès des patients aux traitements.
| Système de paiement | Entités de couverture totale | Taux de remboursement potentiel |
|---|---|---|
| Assurance privée | 285 fournisseurs | 68% |
| Médicament | 50 réseaux d'État | 72% |
| Medicaid | 52 programmes d'État | 55% |
Petros Pharmaceuticals, Inc. (PTPI) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice se terminant le 31 décembre 2023, Petros Pharmaceuticals a déclaré des dépenses de R&D de 4,2 millions de dollars.
| Exercice fiscal | Dépenses de R&D | Pourcentage de revenus |
|---|---|---|
| 2023 | $4,200,000 | 42.5% |
| 2022 | $3,750,000 | 38.2% |
Coûts de gestion des essais cliniques
Les dépenses des essais cliniques pour PTPI en 2023 ont totalisé environ 2,8 millions de dollars.
- Essais de phase I: 750 000 $
- Essais de phase II: 1 350 000 $
- Essais de phase III: 700 000 $
Investissements de conformité réglementaire
Les coûts de conformité réglementaire pour 2023 étaient de 1,5 million de dollars.
| Catégorie de conformité | Frais |
|---|---|
| Coûts de soumission de la FDA | $650,000 |
| Assurance qualité | $450,000 |
| Documentation réglementaire | $400,000 |
Manufacturing and Production Overhead
Les coûts de fabrication totaux pour 2023 ont atteint 3,6 millions de dollars.
- Travail à fabrication directe: 1 200 000 $
- Entretien de l'équipement de production: 800 000 $
- Coûts de matières premières: 1 600 000 $
Dépenses de marketing et de vente
Les frais de marketing et de vente pour 2023 étaient de 2,1 millions de dollars.
| Canal de marketing | Frais |
|---|---|
| Marketing numérique | $650,000 |
| Compensation de l'équipe de vente | $900,000 |
| Participation de la conférence et du salon | $550,000 |
Structure totale des coûts pour 2023: 14,2 millions de dollars
Petros Pharmaceuticals, Inc. (PTPI) - Modèle d'entreprise: Strots de revenus
Ventes de produits pharmaceutiques
Depuis le quatrième trimestre 2023, Petros Pharmaceuticals a rapporté des revenus totaux de produits de 1 237 000 $, principalement à partir de leur produit de plomb DARE-HRT (hormonothérapie de remplacement).
| Produit | Revenus (2023) | Canal de vente |
|---|---|---|
| Dare-hrt | $987,000 | Ventes de prestataires de soins de santé directs |
| Produits secondaires | $250,000 | Distribution de la pharmacie spécialisée |
Licence de propriété intellectuelle
En 2023, PTPI a généré 425 000 $ à partir des accords de licence de propriété intellectuelle.
- Licence de technologie de la thérapie hormonale: 275 000 $
- Brevets de formulation pharmaceutique: 150 000 $
Grants de recherches et collaborations
Le financement de la recherche en 2023 a totalisé 612 000 $ provenant de diverses sources institutionnelles.
| Source de financement | Montant d'octroi |
|---|---|
| Subventions de recherche NIH | $412,000 |
| Collaborations académiques | $200,000 |
Accords de redevances potentielles
Les revenus de redevances pour 2023 étaient de 156 000 $, ce qui représente une augmentation de 12% par rapport à 2022.
Financement des essais cliniques
Le soutien aux essais cliniques et les contrats ont généré 348 000 $ de revenus au cours de 2023.
| Type d'essai | Financement reçu |
|---|---|
| Essais hormones de phase II | $248,000 |
| Essais de recherche en collaboration | $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.
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