Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 265

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 265
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 access, all of which
would adversely affect our business, financial condition, results of operations and prospects.

Further,
there are several factors that could contribute to making the actual number of patients who receive CC8464, CT2000 and CT3000
less than the potentially addressable market. These include the increased use of currently available medication for mild cases
as physicians gain a better understanding diagnosis and treatment of EM and iSFN, the discovery of novel medications for EM and
iSFN and the lack of widespread availability of, and limited reimbursement for, new therapies in many underdeveloped markets.

44 

Government
price controls or other changes in pricing regulation could restrict the amount that we are able to charge for CC8464, CT2000
and CT3000, if approved, or any of our other future compounds that may be approved in the future, which would adversely affect
our revenue and results of operations.

We
expect that coverage and reimbursement of pharmaceutical costs may be increasingly restricted both in the U.S. and internationally.
The escalating cost of health care has led to increased pressure on the health care industry to reduce costs. Drug pricing by
pharmaceutical companies recently has come under increased scrutiny and continues to be subject to intense political and public
debate in the U.S. and abroad. Government and private third-party payors have proposed health care reforms and cost reductions.
A number of federal and state proposals to control the cost of health care, including the cost of drug treatments, have been made
in the US. Specifically, there have been several recent U.S. Congressional inquiries and proposed bills designed to, among other
things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs and
reform government program 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