Proprietary Technology Addressing the Rx-to-OTC Switch Self-Care Market Valued at over $38 Billion annually

Rhea-AI Summary

Petros Pharmaceuticals (NASDAQ:PTPI) announces a strategic shift to focus on developing its proprietary technology platform for Rx-to-OTC switch solutions across multiple therapeutic areas. The company is targeting the self-care market, valued at over $38 billion with a projected 5.6% annual growth rate over the next decade.

The company's technology platform, combining SaaS and Software as a Medical Device (SaMD), aims to facilitate Rx-to-OTC switches for various drugs. Petros is exploring quantum computing partnerships to enhance its AI technology by incorporating health records. As part of this strategic pivot, the company has deprioritized its previous focus on STENDRA's Rx-to-OTC switch.

Positive

• Company targeting $38 billion self-care market with 5.6% CAGR
• Developed proprietary technology platform for Rx-to-OTC switches
• Potential for multiple pharmaceutical partnerships

Negative

• Abandonment of STENDRA Rx-to-OTC switch as primary objective
• Technology platform pending FDA approval
• Uncertain timeline for revenue generation from new strategy

Insights

Market Research Analyst

The pivot towards developing an Rx-to-OTC switch technology platform represents a significant strategic shift for Petros Pharmaceuticals. Targeting the $38 billion self-care market with an expected 5.6% CAGR presents a broader revenue opportunity compared to focusing solely on STENDRA. The SaaS/SaMD approach could provide recurring revenue streams through pharmaceutical partnerships, potentially offering better scalability than single-product commercialization. However, the success heavily depends on FDA approval and industry adoption. The abandonment of STENDRA as primary focus raises concerns about previously invested resources and near-term revenue prospects. This strategic pivot, while ambitious, introduces higher execution risks and longer time-to-market considerations.

Tech Expert

The integration of quantum computing and AI into pharmaceutical regulatory processes marks an innovative approach to drug accessibility. While the technical details are sparse, the platform's potential to automate and streamline Rx-to-OTC switch decisions could revolutionize the industry's traditional approach. However, several critical challenges need addressing: regulatory validation of AI-driven decisions, quantum computing's practical applications in healthcare data processing and cybersecurity concerns with sensitive health records. The technology's success will largely depend on its ability to meet stringent FDA requirements for SaMD certification and demonstrate reliable, reproducible results across different drug categories.

Working to identify quantum computing partnerships to strengthen our AI technology to include critical health records to better enable Rx to OTC switch candidates across multiple indications

NEW YORK, NY / ACCESSWIRE / December 17, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over the counter ("OTC") drug development programs, today announces a shift in its corporate strategy to focus on the development of its proprietary technology platform as a prospective Rx-to-OTC switch solution across a multitude of conditions and existing Rx only therapies. If this Software as a Service ("SaaS") and Software as a Medical Device (SaMD) concept is ultimately approved by the FDA, it could significantly serve 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.

Fady Boctor, Petros' President and Chief Commercial Officer, commented, "During the past few years, as we focused on bringing STENDRA from Rx-to-OTC, we developed a methodology using our technology platform that we believe would facilitate the execution of an Rx-to-OTC switch for a wide variety of prospective drugs. We think that the development of this technology, considering recent FDA and HHS policies, along with advancements in artificial intelligence and quantum computing, presents a more lucrative and lasting commercial opportunity for Petros' value potential."

Petros has developed a proprietary technology-assisted platform that, based on multiple research studies, could help pharmaceutical companies pursue Rx-to-OTC switches. The Company believes that further advancement of this technology, combined with the processing and calculative power of quantum computing, could provide significant opportunities for future pharma partnerships among companies seeking to extend access and commercial viability of their products through an OTC switch.

In light of the Company's new focus to monetize its proprietary Rx-to-OTC switch technology, the completion of the STENDRA Rx-to-OTC switch is no longer the Company's primary objective.

About Petros Pharmaceuticals
Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging $38 billion self-care market by providing expanded access to key prescription pharmaceuticals as OTC treatment options. The Company is currently developing a proprietary SaaS platform designed to assist pharmaceutical companies in meeting FDA standards to assist in the Rx-to-OTC switch.

About the Pathway from Rx to OTC
The process of switching a prescription medication to OTC first involves the design of a Drug Facts Label ("DFL") that is well understood by potential consumers. Then, data must show that consumers can make an appropriate informed decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish this, the FDA ordinarily requires a consumer tested OTC DFL. Such testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting.

The regulations that the FDA is currently in the process of finalizing introduced Additional Conditions for Nonprescription Use ("ACNU") criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process. Petros is developing a technology platform (SaaS) to assist companies in navigating this pathway.

Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ("Petros," "we," "our," "us" or the "Company") management's assumptions, expectations, projections, intentions, and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop," "goal," "plan," "predict", "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should," "target," "strategy" and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its proprietary Rx-to-OTC switch technology Petros' ability to comply with obligations as a public reporting company; Petros' ability to maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates, including its proprietary Rx-to-OTC switch technology. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has filed, or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements.

The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws.

Contacts
Investors:
CORE IR
ir@petrospharma.com

Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com

SOURCE: Petros Pharmaceuticals, Inc.

View the original press release on accesswire.com

FAQ

What is the market value of the Rx-to-OTC switch self-care market targeted by PTPI?

The Rx-to-OTC switch self-care market targeted by PTPI is valued at over $38 billion annually, with an expected compound annual growth rate of 5.6% over the next 10 years.

What is PTPI's new strategic focus announced in December 2024?

PTPI announced a shift in focus to developing its proprietary technology platform as a solution for Rx-to-OTC switches across multiple conditions and therapies, moving away from its previous STENDRA Rx-to-OTC switch priority.

What type of technology is PTPI developing for Rx-to-OTC switches?

PTPI is developing a proprietary platform that combines Software as a Service (SaaS) and Software as a Medical Device (SaMD), enhanced with AI and quantum computing capabilities.

How does PTPI plan to monetize its Rx-to-OTC switch technology?

PTPI plans to monetize its technology through pharmaceutical partnerships with companies seeking to extend access and commercial viability of their products through OTC switches.