Petros Pharmaceuticals, Inc. (PTPI): Business Model Canvas [Dec-2025 Updated]

You're digging into Petros Pharmaceuticals, Inc.'s new playbook, and it's a major pivot: they are betting the farm on a proprietary, AI-driven Software-as-a-Medical-Device (SaMD) platform to facilitate prescription-to-over-the-counter (Rx-to-OTC) drug switches, rather than relying on old product sales. To be fair, this transition is costly; they booked a $(17.7) million operating loss in 2024, but they still hold over $10 million in cash as of May 2025 to fund the intellectual property development. The whole game now is B2B licensing this FDA-aligned tech to big pharma, a necessary move since legacy sales only hit $5.11 million TTM revenue through Q3 2025. This is where the real value proposition lies.

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

You're mapping out the strategic alliances Petros Pharmaceuticals, Inc. (PTPI) is building to commercialize its technology, so let's look at the key players supporting this effort as of late 2025. These partnerships are defintely critical given the company's recent financial restructuring, including a 1-for-25 reverse stock split effective April 30, 2025, which reduced outstanding shares from 53,512,995 to approximately 2,140,520.

The core of the partnership strategy revolves around the development and deployment of their proprietary Software-as-a-Medical Device (SaMD) and Software-as-a-Service (SaaS) platform, which aims to streamline the prescription-to-over-the-counter (Rx-to-OTC) switch process. This platform is designed to tap into the emerging self-care market, currently valued at over $38 billion and expected to grow at a compound annual growth rate (CAGR) of 5.6% over the next decade.

Here's a breakdown of the essential collaborations underpinning the Petros Pharmaceuticals, Inc. (PTPI) strategy:

• Innolitics for Software-as-a-Medical Device (SaMD) platform development: This partnership focuses on integrating cloud-based components like AI and cybersecurity into the SaaS system.
• Renowned Big Data and analytics provider for identity verification: This collaboration strengthens the AI platform with features like Deep Fake detection and improved facial and ID recognition capabilities.
• Pharmaceutical companies for licensing the Rx-to-OTC switch platform: The platform is being built to be licensable across multiple high-value drug categories.
• Regulatory bodies like the FDA for platform alignment and approval: Ongoing discussions and development align with the FDA's final rule, 'Nonprescription Drug Product with an Additional Condition for Nonprescription Use' or ACNU.

We can summarize the structure and associated metrics in the table below. Keep in mind that while the company reported over $10 million in cash reserves, its last twelve months (LTM) revenue was $5.1 million, with a strong gross profit margin of 76%, but also a negative EBITDA of -$7.43 million.

The alignment with the FDA's ACNU framework is supported by internal testing data. The expanded Application Comprehension (App Comp) study, involving 400 patient-consumers, successfully achieved 4 of 5 among the most critical objectives and all 17 important objectives exceeding an 84% Lower Bound (LB) threshold. This data is intended to support the company's belief that its technology can expand access to current Rx medications as OTC products.

The focus on the Big Data partner is specifically around enhancing the identity validation component of the SaMD solution. Enhancements include the addition of Deep Fake detection and mitigation features, plus improved facial and ID recognition capabilities. This is a direct response to the need for robust, commercially viable solutions. Finance: draft 13-week cash view by Friday.

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

Developing and enhancing the proprietary AI-driven SaMD platform

Petros Pharmaceuticals, Inc. is diligently creating a scalable Software as a Medical Device (SaMD) approach, which is integrated into its SaaS-based technology. This platform is designed to help facilitate the Rx-to-OTC switch.

Key technology enhancements implemented as of May 2025 include:

• Addition of Deep Fake detection and mitigation features.
• Improved facial and ID recognition and matching capabilities.
• Enhanced image auto capture feature powered by machine learning technology.

The intended licensable platform is designed to provide patient self-selection tools and electronic health records integration.

Conducting FDA-aligned consumer comprehension studies (App Comp)

The Company conducted an expanded Application Comprehension (App Comp) study involving 400 patient-consumers across 31 objectives. The Company committed approximately $1.8 million to a Contract Research Organization (CRO) to perform these studies.

Results from the expanded study demonstrated success against FDA-aligned thresholds:

An initial study, which informed the larger one, showed 30 out of 31 objectives achieved LB thresholds meaningful to the FDA. For the initial STENDRA study, 29 out of 31 objectives scored >90% comprehension Point Estimate (PE), with 21 scoring 100% PE. This work supports the goal of accessing the emerging self-care market, currently estimated at over $38 billion with a projected CAGR of 5.6% over the next 10 years.

Securing new licensing agreements with pharmaceutical manufacturers

Petros Pharmaceuticals, Inc. is developing the technology to unlock substantial partnership opportunities with pharmaceutical companies seeking OTC conversion. The Company announced a partnership with Innolitics, a leading Software-as-a-Medical-Device Developer, in May 2025. Furthermore, the Company strengthened its partnership with a market-leading Big Data provider in May 2025. The partner in a February 2024 AI licensing agreement was described as a multi-billion-dollar AI software provider.

Maintaining regulatory compliance for the technology platform

The platform development is designed to conform with FDA guidance and the ACNU (Additional Conditions for Nonprescription Use) regulatory framework. The Company has been actively managing its public reporting obligations and listing standards.

Financial metrics relevant to operational continuity and compliance as of late 2024/early 2025 include:

• Net loss for the year ended December 31, 2024: $14.3 million.
• Cash and cash equivalents as of December 31, 2024: $3.7 million.
• Accumulated deficit as of December 31, 2024: $113.2 million.
• Negative working capital as of December 31, 2024: $10.7 million.
• Public offering completed, raising approximately $9.6 million.
• Nasdaq notified the Company on April 8, 2025, of non-compliance with the $2.5 million minimum stockholders' equity requirement.

The Company is working to regain compliance with Nasdaq's minimum bid price requirement, with a compliance period extended to May 12, 2025. Finance: draft 13-week cash view by Friday.

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

You're looking at the core assets Petros Pharmaceuticals, Inc. (PTPI) relies on to execute its strategy of becoming a leader in the technology-assisted Rx-to-OTC switch space. These aren't just ideas; they are tangible and intangible assets that form the foundation of their value proposition as a healthcare technology company.

The most significant resource is definitely the technology itself. Petros has been building a proprietary platform centered around Artificial Intelligence (AI) and Big Data to navigate the complex regulatory pathway for switching prescription drugs to over-the-counter (OTC) status, specifically meeting the FDA's Additional Conditions for Nonprescription Use (ACNU) criteria. This isn't just a simple app; it's a sophisticated Software as a Service (SaaS) and Software as a Medical Device (SaMD) concept.

Here's a quick breakdown of the technology components and some associated figures we have on record:

That cash position is a critical resource, especially for a development-stage tech company. As of May 2025, Petros Pharmaceuticals, Inc. reported having cash and cash equivalents exceeding $10 million. To be fair, other recent filings show a figure closer to $6.07 million, but the $10 million figure was highlighted in connection with their May 2025 strategic updates, suggesting a specific funding event or reporting context. This capital is intended to fully fund the platform's development, especially given the stated goal of a significantly reduced burn rate compared to late 2024.

Intellectual property (IP) is the moat around this technology. The IP centers on the SaMD component and the patient self-selection tools, which are designed to ensure consumers can safely self-select medications previously only available by prescription. This IP is being developed to be licensable, which is the core of their future revenue stream. The platform also includes features like Deep Fake detection and enhanced facial/ID recognition, which are key IP assets for secure patient verification.

You can't build this without the right people. The resource of experienced personnel is evident through their collaborations. For instance, their partnership with Innolitics, a leading developer in the SaMD space, brings in a multi-faceted team. This team includes:

• Software engineers
• Cybersecurity experts
• Regulatory consultants
• AI and machine learning processing experts

Furthermore, the company's leadership, like President and Chief Commercial Officer Fady Boctor, has experience guiding the company through previous Rx-to-OTC switch efforts, like STENDRA, which informed the methodology behind the current technology platform. That institutional knowledge is a resource you can't easily buy.

Finance: draft 13-week cash view by Friday.

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:

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:

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:

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:

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:

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:

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.