Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 55

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 55
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 also prohibit certain marketing- 
 related activities including the provision of gifts, meals, or other items to certain health care providers. Some states restrict       
 the ability of manufacturers to offer co-pay support to patients for certain prescription drugs. Some states require the posting        
 of information relating to clinical studies and their outcomes. Other states and cities require identification or licensing of          
 sales representatives. In addition, several states require pharmaceutical companies to implement compliance programs or marketing       
 codes of conduct; and                                                                                                                   |

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 foreign laws and regulations, including restrictions imposed on the promotion and marketing of medicinal products in the EU member       
 states and other countries, restrictions on interactions with healthcare professionals and requirements for public disclosure            
 of payments made to physicians. Laws (including those governing promotion, marketing and anti-kickback provisions), industry regulations 
 and professional codes of conduct often are strictly enforced. Even in those countries where we may decide not to directly promote       
 or market our products, inappropriate activity by our international distribution partners could have implications for us.                |

Ensuring that our business arrangements and interactions with healthcare professionals, third-party payors, patients and others comply with applicable healthcare laws and regulations will require substantial resources. Various state, federal and foreign regulatory and enforcement agencies continue actively to investigate violations of healthcare laws and regulations, and the United States Congress continues to strengthen the arsenal of enforcement tools.

It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to costly investigations, significant civil, criminal and administrative monetary penalties, imprisonment, damages, fines, disgorgement, exclusion from government funded healthcare programs, such as Medicare and Medicaid, contractual damages, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could substantially disrupt our operations or financial results. Any action against us for violation of these laws or regulations, even if we successfully defend against us, could cause us to incur significant legal expenses and generate negative publicity, which could harm our financial condition and divert our management’s attention from the operation of our business.

Changes in and actual or perceived failures to comply with applicable data privacy, security and protection laws, regulations, standards and contractual obligations may adversely affect our business, operations and financial performance.

We and our partners are or may become subject to federal, state, and foreign laws, requirements and