Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 81

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 81
---
 to potential future commercial demand of ZELSUVMI. Manufacturing API at its own, U.S.-based facility provides the Company
with critical control over the longest lead time and the most complex component of ZELSUVMI’s supply chain.

The
Company currently has sufficient API manufacturing capacity within its facility, as it is configured, to comfortably meet its
current sales forecasts to supply API for ZELSUVMI. In its current configuration, the Company has excess capacity to increase
utilization for additional API demand. Furthermore, the Company also has the ability to add additional manufacturing shifts and
team members to manufacture even greater quantities of API, if needed, for current and potential future partners or customers
of the NITRICIL technology. Effectively, the Company believes the current API theoretical manufacturing capacity could be roughly
doubled, if needed due to one or more of the following: a higher than expected sales demand for ZELSUVMI, demand from current
partners, such as Ligand, and potential future partnerships for ZELSUVMI and/or the NITRICIL platform. The Company does not expect
to need to invest in material or significant capital expenditures and other fixed costs to bring more manufacturing capacity on-line
in the foreseeable future. The Company does expect to incur certain levels of capital expenditures for on-going operations, maintenance
and improvements.

Drug
Product (ZELSUVMI)

The
Company has a long-standing strategic alliance with Orion Corporation (“Orion”), a Finnish full-scale pharmaceutical
company with broad experience in cGMP drug manufacturing. Orion manufactures the Company’s commercial supply of its ZELSUVMI
finished product. The drug product manufacturing and fill/finish process at Orion has been fully validated and qualified including
site registration batches, process validation batches, and commercial batches. Through its contractual relationship with Orion,
the Company has manufactured initial commercial launch quantities of ZELSUVMI. In addition, the Company has entered into a multi-year
supply agreement and provides monthly estimates and forecasts for on-going production of finished products. The Company’s
supply forecast is informed by the expected sales forecast, with adjustments such as MOH, safety stock, shelf life, and product
dating.

48

Intellectual
Property

Under
the license agreement with Ligand, dated March 24, 2025, the Company acquired exclusive rights to a robust IP portfolio that provides
material coverage for ZELSUVMI, which includes patents and patent applications covering the ZELSUVMI product and its use for treating
moll