Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 289

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 289
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 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 trend in the U.S. healthcare industry
and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage
and the amount of payments for particular products. For example, payors may limit coverage to specific drug products on an approved list,
also known as a formulary, which might not include all of the FDA-approved drugs for a particular indication. Payors may require use
of alternative therapies or a demonstration that a product is medically necessary for a particular patient before use of a product will
be covered. Additionally, payors may seek to control utilization by imposing prior authorization requirements.

Increasingly,
third-party payors are requiring that drug companies provide predetermined discounts from list prices and