Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 83

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 83
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 With respect to ZELSUVMI for the treatment
of molluscum contagiosum, the Company will be primarily competing with therapies such as other topical products, natural oils,
off-label drugs, natural remedies, cantharidin or medical procedures such as curettage, cryotherapy, and laser surgery.

International
Opportunities

The
Company, through its exclusive license of ZELSUVMI from Ligand, has the ability to further seek approval for and commercialize
ZELSUVMI through the rest of the world, except for Japan. The Company estimates molluscum contagiosum incidence and prevalence
rates in the European Union and Asia to be comparable to the United States. The Company has previously engaged in several international
discussions with distributors seeking supply or license agreements for ZELSUVMI in multiple ex-U.S. territories.

On
May 12, 2025, the Trump Administration issued an executive order titled Delivering Most-Favored-Nation Prescription Drug Pricing
to American Patients (the “2025 EO”). The 2025 EO outlines a plan to reduce prescription drug prices for Americans.
The 2025 EO directs multiple federal agencies, including the U.S. Department of Health and Human Services (“HHS”),
to take specific actions aimed at compelling drug manufacturers to lower drug prices in the United States in a manner comparable
with other developed nations.

49

On
May 20, 2025, HHS issued a press release stating that the Department “expects each drug manufacturer to commit to aligning
United States pricing for all brand products across all markets that do not currently have generic or biosimilar competition with
the lowest price of a set of economic peer countries.” From this statement, it appears that HHS intends to apply the most-favored-nation
(“MFN”) pricing only to single-source drugs (i.e., “brand-name” drugs without any approved generic or
biosimilar versions). In its May press release, HHS also advised that it will calculate the MFN price as the lowest price in a
country that is part of the Organisation for Economic Co-operation and Development and that has a per capita gross domestic product
(“GDP”) of at least 60% of the U.S. per capita GDP.

The
Company will continue to evaluate the 2025 EO and its potential impact to international opportunities for ZELSUVMI.

Going
Concern

During
the three and nine months
ended September 30, 2025, the Company