Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 110

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 110
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 the availability of third-party coverage and adequate reimbursement for ZELSUVMI for the treatment of molluscum contagiosum and any product candidates that receive regulatory approval; |

| • | the prevalence and severity of any side effects; and |

| • | any restrictions on the use of LNHC’s products together with other medications. |

The failure of healthcare professionals or patients to perceive the benefits of using ZELSUVMI for the treatment of molluscum contagiosum instead of other alternative therapies, such as curettage, cantharidin application or cryotherapy, would adversely affect the commercial success of ZELSUVMI for the treatment of molluscum contagiosum. If LNHC is unable to establish effective sales, marketing and distribution capabilities for ZELSUVMI for the treatment of molluscum contagiosum or any product candidate that may receive regulatory approval, LNHC may not be successful in commercializing ZELSUVMI for the treatment of molluscum contagiosum or LNHC’s product candidates if and when they are approved. LNHC has not yet commercially launched ZELSUVMI for the treatment of molluscum contagiosum. To achieve commercial success for it and any other product candidate for which LNHC may obtain regulatory approval, LNHC will need to establish an effective sales and marketing organization. LNHC has been building a focused sales and marketing organization to launch ZELSUVMI in the United States, but it may not be large enough to support the commercial launch and market acceptance of ZELSUVMI that LNHC expects, and will need to expand if LNHC receives approval of other product candidates. There are inherent risks to establishing and maintaining a standalone commercial organization, which is also time-consuming and requires significant financial resources. Factors that create risk and may inhibit LNHC’s efforts to commercialize LNHC’s products on its own include:

| • | LNHC’s inability to recruit, train and retain adequate numbers of effective sales and marketing personnel; |

| • | the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing any future products; |

| • | inability to obtain favorable insurance coverage of any approved product; |

| • | the lack of complementary products to be offered by sales personnel, which may put LNHC at a competitive disadvantage relative to companies with more extensive product lines; and |

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| • | unforeseen costs and expenses associated with creating an independent sales and marketing organization. |

If LNHC is unable to establish