Company: PTHS
Filing Date: 2025-09-29
Form Type: 424B3
Source: 0001753926-25-001561
Chunk: 43

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-29
Form: 424B3
Chunk 43
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 the prices we may obtain and may have a negative impact on our business and results of operations.

In the United States and some foreign jurisdictions there have been, and continue to be, a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, restrict or regulate post-approval activities with respect to ZELSUVMI and affect our ability to profitably sell our products. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States and elsewhere, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative and regulatory initiatives. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we may receive for ZELSUVMI or any product candidates approved for sale. New and changing laws and regulations may also create uncertainty about how such laws and regulations will be interpreted and applied. If we are found to have violated laws and regulations, it could materially adversely affect our business, results of operations and financial condition.

The ACA was signed into law in 2010. The ACA substantially changed the way healthcare is financed by both governmental and private insurers and significantly affects the U.S. pharmaceutical industry. Among the provisions of the ACA of importance to our business, including, without limitation, our ability to commercialize and the prices we may obtain for any product candidates that are approved for sale, are the following:

| ● | an                                                                                                                             
 annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, 
 apportioned among these entities according to their market share in certain government healthcare programs, although this fee  
 does not apply to sales of certain products approved exclusively for orphan indications;                                       |

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| ● | expansion                                                                                                                               
 of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals 
 with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate              
 liability;                                                                                                                              |

| ● | expansion                                                                                                                    
 of manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded  
 and generic drugs, revising the “average manufacturer price” definition, and extending rebate liability from fee-for