Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 112

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 112
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 large and established companies. These competitors also compete with LNHC in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or that may be necessary for, LNHC’s programs. The commercial success of LNHC’s products and product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payers and others in the medical community. The commercial success of LNHC’s products, including ZELSUVMI and any other products for which it may obtain regulatory approval, will depend in part on the medical community, patients and third-party payers accepting LNHC’s products and product candidates as effective and safe. If these products do not achieve an adequate level of acceptance, LNHC may not generate significant product revenue and may not become profitable. The degree of market acceptance of LNHC’s products will depend on a number of factors, including:

| • | the safety and efficacy of the products, and advantages over alternative treatments; |

| • | the labeling of any approved product; |

| • | the prevalence and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling; |

| • | the prevalence of the disease or condition for which the product is approved; |

| • | the emergence, and timing of market introduction, of competitive products; |

| • | the effectiveness of LNHC’s and its collaboration partners’ marketing strategy; |

| • | obtaining and maintaining adequate pricing and reimbursement; and |

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| • | sufficient third-party insurance coverage or governmental reimbursement, which may depend on LNHC’s ability to provide compelling evidence that a product meaningfully improves health outcomes to support such insurance coverage or reimbursement. |

Even if a product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be known until after it is launched. Any failure to achieve market acceptance of LNHC’s products will harm its business, results and financial condition. Furthermore, government agencies, as well as private organizations involved in healthcare, from time to time publish guidelines or recommendations to healthcare providers and patients. Such guidelines or recommendations can be very influential and may adversely affect product usage directly (for example, by recommending a decreased dosage of a product in conjunction with a concomitant therapy) or indirectly (for example, by recommending a competitive product over a product of LNHC’s). Consequently, LNHC does not know if physicians or patients will adopt or use