Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 106

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 106
---
 will pay for the product once coverage is approved. Third-party payors may limit coverage to specific
products on an approved list, or formulary, which might not include all of the approved products for a particular indication. We may need
to conduct expensive pharmacoeconomic studies to demonstrate the cost-effectiveness of our drug candidates for formulary coverage and
reimbursement, in addition to the costs required to obtain FDA or other comparable regulatory approvals. Even with such studies, our drug
candidates may be considered less safe, less effective or less cost-effective than existing products, and third-party payors may not provide
coverage and reimbursement for our drug candidates, in whole or in part.

In addition, particularly in the United States
and increasingly in other countries, we are required to provide discounts and pay rebates to state and federal governments and agencies
in connection with purchases of our drug candidates that are reimbursed by such entities. It is possible that future legislation in the
United States and other jurisdictions could be enacted to potentially impact reimbursement rates for the drug candidates we are developing
and may develop in the future and could further impact the levels of discounts and rebates paid to federal and state government entities.
Any legislation that impacts these areas could impact, in a significant way, our ability to generate revenues from sales of drug candidates
that, if successfully developed, we bring to market. Political, economic and regulatory influences are subjecting the healthcare industry
in the United States to fundamental changes. There have been, and we expect there will continue to be, legislative and regulatory proposals
to change the healthcare system in ways that could significantly affect our future business.

In the European Union, pricing and reimbursement
schemes vary widely from country to country. Some Member States provide that products may be marketed only after a reimbursement price
has been agreed, whereas other Member States may require the completion of additional studies that compare the cost-effectiveness of a
particular drug candidate to currently available therapies or so-called health technology assessments, in order to obtain reimbursement
or pricing approval. For example, the European Union provides options for its Member States to restrict the range of products for which
their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. Member States
may approve a specific price for a product or may instead adopt a system of direct or indirect controls on the profitability of the company
placing the product on the market. Other Member States allow companies to fix their own prices for products, but the competent authorities
in such Member States