Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 115

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 115
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 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 to achieve or maintain profitability. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. The FDA strictly regulates marketing, labeling, advertising and promotion of prescription drugs. These regulations include standards and restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving the internet and off-label promotion. Any regulatory approval that the FDA grants, including the approval of ZELSUVMI, is limited to those specific diseases and indications for which a product is deemed to be safe and effective by FDA. While physicians in the United States may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, LNHC’s ability to promote ZELSUVMI or any future products will be narrowly limited to those indications that are specifically approved by the FDA. ZELSUVMI has been approved by the FDA for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older, and LNHC is not permitted to promote ZELSUVMI for other uses. If LNHC is found to have promoted such off-label uses, LNHC may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also required that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If LNHC cannot successfully manage the promotion of ZELSUVMI or any future product candidates, if approved, LNHC could become subject to significant liability, which would materially adversely affect its business and financial condition. Product liability lawsuits could cause LNHC to incur substantial liabilities and limit commercialization of any products that it may develop. LNHC faces an inherent risk of product liability exposure related to the commercial sales of ZELSUVMI, as well as the testing of LNHC’s potential future product candidates in human clinical trials. If LNHC cannot successfully defend itself against claims that ZELSUVMI or such product candidates caused injuries, LNHC will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result