Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 393

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 393
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 (berdazimer gel, 10.3%) as a topical prescription gel for the treatment of viral skin infections, with a focus on molluscum contagiosum. In January 2023, Novan submitted a New Drug Application to the U.S. Food and Drug Administration (the “FDA”) for berdazimer gel, 10.3% as a topical treatment for molluscum contagiosum which was subsequently approved by the FDA on January 5, 2024, and is commercially known as ZELSUVMI. As of the effective date of Novan Acquisition, all assets and liabilities acquired by Ligand in the Novan Acquisition have been held by LNHC, which is a wholly owned subsidiary of Ligand. Unless the context otherwise requires, the “Company,” for periods after the Novan Acquisition, refers to LNHC (“Successor”), and for the periods prior to the Novan Acquisition, refers to the corresponding part of Novan’s business that was subsequently acquired by Ligand in the Novan Acquisition and contributed into LNHC (“Predecessor”). As a result of the Novan Acquisition accounting, the results of operations, financial position and cash flows of the Predecessor and Successor are not directly comparable. Key Factors Affecting Our Results of Operations and Future Performance We believe that our financial performance has been, and in the foreseeable future will continue to be, primarily driven by multiple factors as described below, each of which presents growth opportunities for our business. These factors also pose important challenges that we must successfully address in order to sustain our growth and improve our results of operations. Our ability to successfully address these challenges is subject to various risks and uncertainties, including those described in the section of this prospectus titled “Risk Factors.”

| • | We must effectively implement and maintain sales, marketing and distribution capabilities for our products to successfully commercialize and generate revenues from our products. |

| • | Our products must achieve a broad degree of physician and patient adoption and use necessary for commercial success. The commercial success of our approved products depends significantly on the broad adoption and use of such products by physicians and patients for approved indications. |

| • | Our product revenues will be dependent on sales to a few significant wholesale customers and the loss of, or substantial decline in, sales to one of these wholesale customers could have a material adverse effect on our expected future revenues and profitability. |

| • | Delays or disruptions in our supply chain and the manufacturing of our product could adversely affect our sales and marketing efforts.