Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 82

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 82
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uscum contagiosum; trademarks; and know-how and trade secrets covering various aspects of the nitric oxide NITRICIL Technology
Platform in addition to manufacturing, research, development, formulation, analytical chemistry and scientific know-how.

There
are 14 issued U.S. patents covering ZELSUVMI which are listed in the Orange Book and which are expected to expire during the time
period beginning in 2026 and ending in 2035. Upon the initial approval of ZELSUVMI, the Company applied for 1,280 days of patent
term extension (“PTE”) for the U.S. patent covering ZELSUVMI compositions. Assuming grant of the PTE application,
the term of this patent may be extended from February 27, 2034, to August 30, 2037.

Our
Customers

The
Company primarily sells its ZELSUVMI product to national wholesaler channels and specialty distributors. Our wholesalers and distributors
purchase products from us and, in turn, supply products to retail drug store chains, independent pharmacies and others. As of
September 30, 2025, three of the Company’s wholesaler customers accounted for more than 94% of its total gross accounts
receivable balance at 34%, 32% and 28%, respectively

Seasonality
of Business

Our
business may be affected by the standard annual insurance deductible resets, as well as the purchasing patterns and concentration
of our customers. In addition, certain conditions, such as molluscum, may be impacted by the warmer months and prescriptions may
also be impacted based on the activities of those who are prescribed our products, such as school and summer activities; however,
our business is not materially impacted by seasonality. There are no assurances that these historical trends will continue in
the future.

Competition

The
pharmaceutical industry is subject to rapidly advancing technologies, intense competition, and a strong emphasis on proprietary
products. The Company faces potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical
and biotechnology companies, compounding facilities, academic institutions, governmental agencies, and public and private research
institutions.

ZELSUVMI
is the first and only FDA-approved prescription pharmaceutical therapy for the treatment of molluscum contagiosum that can be
administered by patients or caregivers outside of a medical setting. The Company believes the key competitive factors affecting
the success of ZELSUVMI are likely to be its efficacy, safety, convenience, and pricing.