Company: PTPI
Filing Date: 2025-02-19
Form Type: 424B4
Source: 0001410578-25-000164
Chunk: 40

Company: Petros Pharmaceuticals, Inc.
Filing Date: 2025-02-19
Form: 424B4
Chunk 40
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 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 that is dependent on Vivus’ license agreement with a third party; and |

| ● | Vivus has granted a license to Hetero USA, Inc. and Hetero Labs Limited to manufacture and commercialize the generic version of Stendra® in the United States once it comes off patent. |

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Risks Related to Petros’ Personnel Because Petros is a small company with limited resources, it may be unable to attract qualified personnel. Because of the specialized nature of its business, Petros’ ability to develop products and to compete with its current and future competitors largely depends upon its ability to attract, retain and motivate highly qualified managerial, marketing, engineering, consulting and scientific personnel. Petros faces intense competition for qualified employees and consultants from biopharmaceutical companies, research organizations and academic institutions. Attracting, retaining or replacing these personnel on acceptable terms may be difficult and time-consuming given the high demand in its industry for similar personnel. There is intense competition for qualified personnel in this business sector, and we cannot assure you that Petros will be able to attract the qualified personnel necessary for the development of its business. Petros will need to expand its operations and increase its size, and it may experience difficulties in managing growth. As Petros begins to sell its platform service, it may need to increase personnel headcounts with respect to sales