Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 47

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 47
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 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-service 
 Medicaid utilization to include the utilization of Medicaid managed care organizations as well;                              |

| ● | expansion                                                                                                                           
 of the list of entity types eligible for participation in the Public Health Service 340B drug pricing program, or the 340B program, 
 to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals, 
 but exempting “orphan drugs” from the 340B ceiling price requirements for these covered entities;                                   |

| ● | a                                                                                                                               
 Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness 
 research, along with funding for such research; and                                                                             |

| ● | establishment                                                                                                                 
 of the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower 
 Medicare and Medicaid spending, including prescription drug spending.                                                         |

Since its enactment, certain provisions of the ACA have been subject to judicial, executive, and legislative challenges and may be subject to additional challenges in the future. In addition, other legislative changes have been proposed and adopted since the ACA was enacted. For example, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory Medicaid