Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 266

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 266
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 reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage
and reimbursement for our products, if approved, could limit our ability to market those products and decrease our ability to
generate product revenue.

We
expect that coverage and reimbursement by government and private payors will be essential for most patients to be able to afford
these treatments. Accordingly, sales of our compounds will depend substantially, both domestically and abroad, on the extent to
which the costs of our compounds will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management
organizations, or will be reimbursed by government authorities, private health coverage insurers and other third-party payors.
Coverage and reimbursement by a third- 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 us
to provide to the payor supporting scientific, clinical and cost-effectiveness data. We 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, we may not be able to successfully commercialize our compounds. Even if coverage is provided, the approved
reimbursement amount may not be adequate to realize a sufficient return on our investment.

45 

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 us. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health
systems. It