Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 107

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 107
---
 monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. Recently, many
countries in the European Union have increased the amount of discounts required for medicinal products, and such efforts could continue
as countries attempt to manage healthcare expenditures, especially in light of the severe fiscal and debt crises experienced by such countries.
The downward pressure on healthcare costs in general, particularly prescription products, has become intense. As a result, increasingly
high barriers are being erected to the entry of new products. Political, economic and regulatory developments may further complicate pricing
negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various Member States,
and parallel trade, i.e., arbitrage between low-priced and high-priced Member States, can further reduce prices.

34

In international markets, reimbursement and healthcare
payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. Future
legislation, or regulatory actions implementing recent or future legislation may have a significant effect on our business. Our ability
to successfully commercialize products depends in part on the extent to which reimbursement for the costs of our drug candidates and related
treatments will be available in the United States and worldwide from government and health administration authorities, private health
insurers and other organizations. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an adequate
reimbursement rate will be approved. Third-party reimbursement may not be sufficient to maintain price levels high enough to realize an
appropriate return on investment in product development. The adoption of certain proposals could limit the prices we are able to charge
for our drug candidates, the amounts of reimbursement available for our drug candidates, and limit the acceptance and availability of
our drug candidates. Therefore, substantial uncertainty exists as to the reimbursement status of newly approved healthcare products by
third-party payors.

Healthcare Reform and Potential Changes to Healthcare Laws

The FDA’s and other regulatory authorities’
policies may change, and additional government regulations may be enacted, that could prevent, limit or delay regulatory approval of our
drug candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies,
or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we
may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

A primary trend in the U.S. healthcare industry
and elsewhere