EXCLUSIVE: “Prescription erectile dysfunction market could triple if an ED therapy is available OTC,” says Petros Pharma President – Petros Pharma (NASDAQ:PTPI)

Here is a summary of the questions and answers:

• Gasoline: Can you tell us more about your company and products and how you differentiate yourself from the competition?
• Fady Boctor: “We have a broad network and deep talent in the Rx-to-OTC switch market. We have decades of experience in the Rx, switch and FDA regulatory landscape. This enables us to leverage industry best practices and meaningful familiarity with the factor largest rate-limiting in process, FDA.
• Gasoline: Petros is pursuing increased access to its leading prescription erectile dysfunction therapy, Stendra (avanafil), a potential OTC designation. What could be the benefits of this move?
• Fady Boctor: The $1.4 billion prescription ED market could triple if an ED therapy were made available over the counter (OTC). Nearly 75% of men in the US avoid seeking prescription ED therapy because of the embarrassment and stigma of discussing it with a doctor. This presents an important opportunity to increase access and use among the 30 million men in the US who currently suffer from ED.
• During the recent Type C meeting between Petros and the FDA, the Agency also aligned with the company regarding the submission and review of its pivotal two-arm Self-Selection study, which is currently underway.
• Gasoline: What do you think is the future of the OTC prescription market and how does Petros Pharmaceuticals plan to capitalize on the opportunities?
• Fady Boctor: “The prospects for the Rx-to-OTC transition market are significant. With the FDA proposing new rules for assistive technology services, products that have never been used for OTC transition are now viable prospects.
• Gasoline: What is your strategy for expanding your portfolio and pipeline?
• Fady Boctor: “We then plan to apply our diverse and deep experience in the change process, including technological know-how, to bring those solutions to fruition.”
• Gasoline: Can you discuss the recently executed exclusive licensing agreement for the treatment of Peyronie’s disease?
• Fady Boctor: “This deal has been de-prioritized and withdrawn due to our focus on transitioning our leading prescription ED drugs to OTC.”
• Gasoline: Are there any plans the company has to enter women’s health?
• Fady Boctor: The women’s health sector has recently made significant progress in increasing OTC access and awareness. The company is continuously collaborating with various partners on potential therapeutics for women’s health that hold promise for transition to OTC status.
• Gasoline: As the company is focused on men’s health, what are the main challenges and opportunities?
• Fady Boctor: The main challenges in men’s health focus on two areas. First, the market is flooded with non-FDA-approved supplements that claim therapeutic benefits without rigorous clinical evidence, creating confusion and misinformation.
• Second, transitioning some pharmaceutical-grade products to over-the-counter status is complex and requires clear communication with consumers about safe and appropriate use.
• “We believe we are embracing this challenge as an opportunity.”
• Gasoline: Can you share the company’s growth prospects in the near and medium term?
• Fady Boctor: Our growth prospects are focused on transitioning the first prescription ED therapy to OTC status. It targets a significant portion of the multi-billion dollar ED market.

Price Action: PTPI stock closed at $0.41 on Friday.