Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 77

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 77
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 reimbursement methodologies for drugs. In some international markets, the government controls the pricing,
which can affect the profitability of drugs. Current government regulations and possible future legislation regarding health care
may affect coverage and reimbursement for medical treatment by third-party payors, which may render our compounds, if approved,
not commercially viable or may adversely affect our anticipated future revenues and gross margins.

We
cannot predict the extent to which our business may be affected by these or other potential future legislative or regulatory developments.
However, future price controls or other changes in pricing regulation or negative publicity related to the pricing of pharmaceutical
drugs generally could restrict the amount that we are able to charge for our future products, which would adversely affect our
anticipated revenue and results of operations.

The
insurance coverage and 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