Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 146

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 146
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 to market with competing products,
whether approved as a direct ANDA competitor or as a Section 505(b)(2) NDA referencing one of our future drug candidates. If the FDA
approves generic versions of any of our products in the future, should they be approved for commercial marketing, such competitive products
may be able to immediately compete with us in each indication for which our product has received approval, which could negatively impact
our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on our investments.

In addition, while we are currently exploring potential patent protection
strategies for our lead drug candidate, PSX-001, there can be no assurance that our efforts to provide intellectual property protection
for PSX-001 will be successful. As such and if approved, we may experience significant competition in connection with our marketing efforts
for PSX-001.

Even
if we are able to commercialize any of our drug candidates, such products may become subject to unfavorable pricing regulations, third-party
reimbursement practices or healthcare reform initiatives, which would harm our business.

The
regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country.
Current and future legislation may change the approval requirements in ways that could involve additional costs and cause delays in obtaining
approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review
period begins after marketing approval is granted and, in some markets, prescription pharmaceutical pricing remains subject to continuing
governmental control even after initial approval is granted. As a result, we may obtain marketing approval for a product in a particular
country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods,
and negatively impact the revenues we are able to generate from the sale of the product in that country. Adverse pricing limitations
may hinder our ability to recoup our investment in one or more drug candidates, even if our drug candidates obtain marketing approval.

56

Our
or a partner’s ability to commercialize any drug candidates successfully also will depend in part on the extent to which coverage
and reimbursement for these drug candidates and related treatments will be available from government authorities, private health insurers
and other organizations. In the United States, reimbursement varies from payor to payor. Reimbursement agencies in Europe may be more
conservative than federal healthcare programs or private health plans in the United States. A primary