Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 290

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 290
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 are challenging the prices
charged for products. We cannot be sure that coverage will be available for any drug candidate that we commercialize and, if coverage
is available, what the level of reimbursement will be. Reimbursement may impact the demand for, or the price of, any drug candidate for
which we obtain marketing approval. Patients are unlikely to use our products, if they are approved for marketing, unless coverage is
provided, and reimbursement is adequate to cover a significant portion of the cost of such products.

There
may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the
purposes for which the drug is approved by the FDA, EMA, MHRA or other comparable regulatory agencies. Moreover, eligibility for reimbursement
does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,
sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may
not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may
be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services.
Net prices for drugs may be reduced by mandatory discounts or rebates required by federal healthcare programs or private payors and by
any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in
the United States. In the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting
their own reimbursement policies. In the European Union, reference pricing systems and other measures may lead to cost containment and
reduced prices. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors
for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital
needed to commercialize products and our overall financial condition.

Further,
there have been, and may continue to be, legislative and regulatory proposals at the U.S. federal and state levels and in other jurisdictions
directed at broadening the availability and containing or lowering the cost of healthcare. The continuing efforts of the government,
insurance companies, managed care organizations and other third-party payors to contain or reduce costs of healthcare may adversely affect
our ability to set prices for our products that would allow us to achieve or