Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 291

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 291
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 sustain profitability. In addition, governments may impose
price controls on any of our products that obtain marketing approval, which may adversely affect our future profitability.

In August 2022, President Biden signed into the
law the IRA, which among other things, contains multiple provisions that may impact the prices of drug products that are both sold into
the Medicare program and throughout the United States, including mandatory rebates to the federal government if a drug product’s
price increases faster than the rate of inflation and direct government negotiation of drug prices for certain Part D drugs (starting
for payment year 2026) and Part B drugs (starting for payment year 2028). If a drug product is selected by CMS for negotiation, it is
expected that the revenue generated from such drug will decrease. Additional state and federal healthcare reform measures are expected
to be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products
and services, which could result in reduced demand for certain pharmaceutical products or additional pricing pressures.

57

In some other countries, particularly the Member
States of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing
negotiations with governmental authorities can be a long and expensive process after the receipt of marketing approval for a drug candidate.
In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as
part of cost containment measures. 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 European Union member states and parallel
distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, we may be required
to conduct additional clinical trials that compare the cost-effectiveness of our drug candidates to other available therapies in order
to obtain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure
on prices or reimbursement levels within the country of publication and other countries. If reimbursement of our products is unavailable
or limited in scope or amount in a particular country, or if pricing is set at unsatisfactory levels, we may be unable to successfully
commercialize and achieve or sustain profitability for sales of any of our drug candidates that are approved for marketing in that country
and our business could be adversely affected.

We could become exposed to product liability claims that could
adversely affect our business.