Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 151

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 151
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 require LNHC to devote resources to advertising and marketing new brands. Further, there can be no assurance that competitors will not infringe LNHC’s trademarks or that LNHC will have adequate resources to enforce its trademarks.**

**Risks Related to Legal and Regulatory Compliance Matters**

**Current and future healthcare reform legislation or regulation may increase the difficulty and cost for LNHC to commercialize ZELSUVMI and may adversely affect the prices LNHC may obtain and may have a negative impact on LNHC’s business and results of operations.

In the United States and some foreign jurisdictions there have been, and continue to be, a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, restrict or regulate post-approval activities with respect to ZELSUVMI and affect LNHC’s ability to profitably sell its products. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality**

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and/or expanding access. In the United States and elsewhere, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative and regulatory initiatives. LNHC expects that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that LNHC may receive for ZELSUVMI or any product candidates approved for sale. New and changing laws and regulations may also create uncertainty about how such laws and regulations will be interpreted and applied. If LNHC is found to have violated laws and regulations, it could materially adversely affect LNHC’s business, results of operations and financial condition. The ACA was signed into law in 2010. The ACA substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affects the U.S. pharmaceutical industry. Among the provisions of the ACA of importance to LNHC’s business, including, without limitation, its ability to commercialize and the prices LNHC may obtain for any product candidates that are approved for sale, are the following:

| • | an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs, although this fee does not apply to sales of certain products approved exclusively for orphan indications; |

| • | expansion of eligibility criteria for