Company: PTPI
Filing Date: 2025-01-24
Form Type: S-1
Source: 0001410578-25-000047
Chunk: 38

Company: Petros Pharmaceuticals, Inc.
Filing Date: 2025-01-24
Form: S-1
Chunk 38
---
 Stendra® in the future, it may face a wide range of risks similar to those previously associated with the development and commercialization of Stendra®. If the Company decides to resume the manufacturing, development and commercialization of Stendra® in the future, it may face a wide range of risks similar to those previously associated with the marketing, development and commercialization of Stendra®, including operational, regulatory and market challenges. These risks may adversely affect the Company’s financial performance, reputation and long-term strategic objection. Such risks include, but are not limited to:

| ● | we will depend on a limited number of customers for a significant portion of our sales of Stendra® and the loss of, or a significant shortfall in demand from, these customers could have a material adverse effect on our financial condition and operating results; |

| ● | events having a material adverse effect on Stendra® sales may result in a significant adverse impact on our revenues; |

| ● | we may experience delays or problems in the supply of Stendra® if Patheon experiences delays in or fails to establish and validate its ability to manufacture supply of the Company’s Stendra® product, which could materially and adversely affect our ability to obtain sufficient quantity of Stendra® API to meet market demand; |

21

| ● | Petros will rely on a combination of several different channels to promote Stendra® to physicians and patients in the United States and internationally; |

| ● | changes in product or product candidate manufacturing or formulation may result in additional costs or delay; |

| ● | we may experience pricing pressure on the price of our products due to social or political pressure to lower the cost of drugs, which would reduce our revenue and future profitability, if achieved; |

| ● | Stendra® may face competition from generic drug products and other similar drug products; |

| ● | we may continue to pursue, under FDA guidance and approval, switching its flagship pharmaceutical product, Stendra®, from prescription only designation to OTC or non-prescription designation. As this process requires a number of studies, often numerous iterations of each stage, if FDA requires reiterations beyond scope of project estimation, this may significantly hinder project development, potentially delaying pathway and requiring additional capital to continue; |

| ● | if we are unable to advance Stendra® OTC designation, in clinical development, obtain regulatory approval and ultimately commercialize it, or experience significant delays in doing so, its business may be materially harmed; |

| ● | our license agreement for Stendra® is a sublicense