Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 75

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 75
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 have a market development organization. To successfully commercialize CC8464, CT2000 and CT3000, if approved,
we will need to expand our capabilities to promote market access and build awareness. To successfully commercialize any other
products that may result from our development programs, we will need to further expand our market development organization, either
on our own or with a third party. The development of our own market development team will be expensive and time-consuming and
could delay any product launch. Moreover, we cannot be certain that we will be able to successfully develop this capability. We
may enter into collaboration agreements regarding any of our compounds with third parties to utilize their established marketing
and distribution capabilities, but we may be unable to enter into such agreements on favorable terms, if at all. If any future
collaborators do not commit sufficient resources to commercialize our products, or we are unable to develop the necessary capabilities
on our own, we will be unable to generate sufficient product revenue to sustain our business. We compete with many companies that
currently have extensive, experienced and well-funded medical affairs, marketing and sales operations to recruit, hire, train
and retain marketing and sales personnel. We also face competition in our search for third parties to assist us with the sales
and marketing efforts of our compounds. Without an internal team or the support of a third party to perform marketing and sales
functions, we may be unable to compete successfully against these more established companies.

Our
efforts to educate the medical community and third-party payors on the benefits of our compounds may require significant resources
and may never be successful. Such efforts may require more resources than are typically required due to the complexity and uniqueness
of our potential products. If any of our compounds are approved but fails to achieve market acceptance among physicians, patients
or third-party payors, we will not be able to generate significant revenues from such product, which could have a material adverse
effect on our business, financial condition, results of operations and prospects.

If
the market opportunities for CC8464, CT2000, CT3000 or our future compounds are smaller than we believe they are, our revenues
may be adversely impacted, and our business may suffer.

We
are currently focusing our research and product development efforts on CC8464 for the management of EM and iSFN, CT2000 for acute
and chronic eye pain, CT3000 for post-surgical pain and, potentially, other fields of neuropathic pain. Our understanding of both