Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 114

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 114
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 in the U.S. until it enters into payor negotiations. If coverage and reimbursement are not available or available only to limited levels, LNHC may not be able to generate sufficient revenue to meet its operating costs or to achieve its revenue, cash flow breakeven or profitability goals in the timeframe that it expects, or at all. The market for ZELSUVMI for the treatment of molluscum contagiosum and LNHC’s future product candidates may not be as large as LNHC expects. Molluscum contagiosum is a skin disease that is currently undertreated. Even with approval of ZELSUVMI for the treatment of molluscum contagiosum in adult and pediatric patients one year and older, individuals may continue to decline treatment for molluscum contagiosum as, if left untreated, the diseases will eventually be resolved by the body’s immune system. In addition, LNHC’s estimates of the potential market opportunity for ZELSUVMI for the treatment of molluscum contagiosum include several key assumptions based on LNHC’s industry knowledge, industry publications, third-party research reports, IDC-10 claims data, and surveys of dermatologists commissioned by LNHC. These assumptions include the current treatment rates and/or prevalence of molluscum contagiosum and other skin diseases as well as the estimated coverage levels for ZELSUVMI. However, there can be no assurance that any of these assumptions are, or will remain, accurate. Furthermore, even if LNHC’s estimates relating to claims data

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and/or the prevalence of molluscum contagiosum and other skin diseases as well as the estimated coverage levels for ZELSUVMI for the treatment of molluscum contagiosum or any future product candidate LNHC may develop, as applicable, are accurate, the degree of market acceptance by the medical community and those infected by such skin diseases following regulatory approval could impact LNHC’s assumptions and reduce the market size for ZELSUVMI for the treatment of molluscum contagiosum and any other product that may be approved. Furthermore, the market research study LNHC commissioned surveying payor organizations has no bearing on the payors, and any assumptions or interpretations based on the results of this study, may ultimately be inaccurate. If the actual markets for ZELSUVMI for the treatment of molluscum contagiosum or any future product candidates are smaller than LNHC expect, LNHC’s revenues, if any, may be limited and it may be more difficult for it