Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 145

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 145
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 wholly owned subsidiary of Ligand.

Unless the context otherwise requires, the “Company” refers to LNHC.

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 Form 8-K/A 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. |

| ● | Unexpected                                                                                                                                  
 results in the analysis of raw materials, the API or drug product or problems with the execution of or quality systems supporting           
 the analytical testing work, whether conducted internally or by third-party service providers, could adversely affect our commercialization 
 activities.                                                                                                                                 |

Components of Results of Operations

Revenue

Revenue in all periods is primarily related to recognition of deferred revenue from a collaboration agreement with Sato Pharmaceutical Co., Ltd. (“Sato Agreement”). For information about Sato Agreement, see Note (3), Sato Agreement in the notes to our condensed financial statements.

Research and Development Expenses

Research and development expenses include all direct and indirect development costs incurred for the development of ZELSUVMI. These expenses include salaries and related costs, including stock-based compensation and travel costs for research and development personnel, allocated facility costs, laboratory and manufacturing materials and supplies, consulting fees, product development, preclinical studies, clinical trial costs, licensing fees and milestone payments under license agreements and other fees and costs related to the development of drug