Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 73

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 73
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 party payor may depend upon several factors, including the third-party payor’s determination that use of a product is:

| • | a covered benefit under its health plan; |

| • | safe, effective and medically necessary; |

| • | appropriate for the specific patient; |

| • | cost-effective; and |

| • | neither experimental nor investigational. |

Obtaining coverage and reimbursement for a product from third-party payors is a time-consuming and costly process that could require Channel to provide to the payor supporting scientific, clinical and cost-effectiveness data. Channel may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. If coverage and reimbursement are not available, or are available only at limited levels, it may not be able to successfully commercialize its compounds. Even if coverage is provided, the approved reimbursement amount may not be adequate to realize a sufficient return on its investment. There is significant uncertainty related to third-party coverage and reimbursement of newly approved products. In the United States, third-party payors, including government payors such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered and reimbursed. The Medicare and Medicaid programs increasingly are used as models for how private payors and government payors develop their coverage and reimbursement policies. Outside the United States, international operations generally are subject to extensive government price controls and other market regulations and increasing emphasis on cost-containment initiatives in the European Union, Canada and other countries may put pricing pressure on Channel. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. It also can take a significant amount of time after approval of a product to secure pricing and reimbursement for such product in many counties outside the United States. In general, the prices of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for medical products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that Channel is able to charge for its compounds. Accordingly, in markets outside the United States, the reimbursement for its products will be reduced compared with the United States and may be insufficient to generate commercially reasonable product revenues. Moreover, increasing efforts by government and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for new products approved and, as a result, they may