Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 267

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 267
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 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 we are
able to charge for our compounds. Accordingly, in markets outside the United States, the reimbursement for our 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 not cover or provide adequate payment for our compounds. Payors increasingly are considering new metrics as the basis for
reimbursement rates, such as average sales price, average manufacturer price, and Actual Acquisition Cost. The existing data for
reimbursement based on some of these metrics is relatively limited, although certain states have begun to survey acquisition cost
data for the purpose of setting Medicaid reimbursement rates, and CMS has begun making pharmacy National Average Drug Acquisition
Cost and National Average Retail Price data publicly available on at least a monthly basis. Therefore, it may be difficult to
project the impact of these evolving reimbursement metrics on the willingness of payors to cover candidate products that we or
our partners are able to commercialize. We expect to experience pricing pressures in connection with the sale of any of our product
candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional
legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures
and other treatments, has become intense. As a result, increasingly high barriers are being erected to the entry of new products
such as ours.

Risks
Related to Our Business Operations

We
may not be successful in our efforts to identify or discover additional compounds and may fail to capitalize on programs or compounds
that may be a greater commercial opportunity or for which there is a greater likelihood of success.

Beyond
the development and commercialization of CC8464, CT2000 and CT3000, the future success of our business depends upon our ability
to identify, develop and commercialize compounds based on the platform technology. CC8464