Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 148

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 148
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 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 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