NEW YORK - Petros Pharmaceuticals, Inc. (NASDAQ: PTPI), a company focused on expanding consumer access to medication through over the counter (OTC) pathway provides the below Letter to Shareholders.
To our valued shareholders
As we approach the fourth quarter of 2023, Petros has been quietly undergoing a change in approach to our business. As we have previously announced, our evolving focus has shifted from prioritizing the commercialization of prescription STENDRA, which continues to be a source of revenue for us, to developing and executing on a new pathway toward non-prescription or potentially over-the-counter access for our current lead product. As part of our strategy, we are utilizing new proposed FDA rules to safely bring mature Rx products to the market without the requirement of an authorized prescription. Importantly, we believe that the pathway we are developing may also serve as a template for bringing other mature Rx products that may be similarly appropriate to utilize.
Today we launch our newest investor presentation, which outlines the pathway, as well as a multitude of milestones along the way, some of which have already been achieved. These milestones range from the creation and testing of a consumer-facing label to help ensure that only those men appropriate for STENDRA use are accessing it, to the development of technology to help ensure the safety of those men. The development of this technology has already begun and provides several opportunities to utilize a variety of current advancements, including the potential use of machine learning/artificial intelligence. We are currently exploring several potential partnerships that we believe will help to create the optimal technology and to help position Petros into the future as a leader in the Rx to OTC switch.
Further, our management and certain members of our Board of Directors have experience in the execution of marketing former Rx products into the OTC arena, and we are gathering a team of additional advisors to help ensure that our work is in accordance with current and potential FDA regulations, and optimized to a market that must change its mindset from that of prescription medication to OTC.
We hope the new presentation provides ample explanation of our new approach, as well as the pathway we have laid out in terms of potential milestones in the near future. We look forward to sharing our progress along the way and thank you for your continued support of Petros Pharmaceuticals.
Sincerely, Fady Boctor, President and Chief Commercial Officer
About Petros Pharmaceuticals
Petros Pharmaceuticals is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over the Counter or nonprescription treatment options. Currently, Petros is pursing increased access for its flagship prescription ED therapy, STENDRA, for potential OTC or nonprescription designation. If ultimately approved and designated by the FDA for OTC or nonprescription access, STENDRA may be the first in its class to achieve the designation, also establishing company know how as a proven platform for other prospective prescription therapeutics.
About the OTC Pathway
The process of switching a prescription medication to over-the-counter (OTC) involves the design of a clear to laymen, shelf-friendly medication label, demonstrated comprehension of key safety parameters, and proven, appropriate consumer self-selection. The FDA ordinarily requires a consumer tested OTC Drug Facts label (DFL), Label Comprehension Studies (LCS), Self Selection Studies (SSS), and at least one Actual Use Trial (AUT) demonstrating safe and appropriate non-practitioner-guided, yet consumer-led use. Recently, a communication by FDA introduced Additional Conditions for Non-prescription Use (ACNU) criteria that may expand OTC access to several prescription medications and enable innovative tools to help support the switch process.
About STENDRA (avanafil)
Stendra (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company s sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as 15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. Stendra was designed and developed expressly for erectile dysfunction. The Company recently undertook a relaunch of Stendra, generating gross revenues of approximately $30 million in 2019. Petros intends to accelerate the relaunch of Stendra with a well-funded commercial organization and refocused strategy.
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 product candidates; Petros ability to comply with obligations as a public reporting company; Petros ability to regain and 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; risks related to Petros dependence on the commercialization of a single product, STENDRA; risks related to Petros ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates and the long term impact of the novel coronavirus ( COVID-19 ), and the related responses of governments, consumers, customers, suppliers, employees and the Company, on our business, operations, employees, financial condition and results of operations. 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 of 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.
Contact:
Email: ir@petrospharma.com
PETROS PHARMACEUTICALS 
