Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 158

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 158
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. In December 2020, the U.S. Supreme Court held unanimously
that federal law does not preempt the states’ ability to regulate PBMs, and other members of the healthcare and pharmaceutical supply
chain, an important decision that may lead to further and more aggressive efforts by states in this area. Then, in mid-2022, the FTC launched
sweeping investigations into the practices of the PBM industry that could lead to additional federal and state legislative or regulatory
proposals targeting such entities’ operations, pharmacy networks, or financial arrangements. In addition, in the last few years,
several states have formed prescription drug affordability boards (“PDABs”), with the authority to implement upper payment
limits (“UPLs”), on drugs sold in their respective jurisdictions. There are several pending federal lawsuits challenging the
authority of states to impose UPLs, however.

Outside of the United States, particularly in the
European Union, the coverage status and pricing of prescription pharmaceuticals and biologics is subject to governmental control. In these
countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a
product. Furthermore, the requirements may differ across the EU Member States. To obtain coverage and reimbursement or pricing approval
in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our drug candidate to other
available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory
levels, our business could be harmed. Also, at a national level, actions have been taken to enact transparency and anti-gift laws (similar
to the U.S. Physician Payments Sunshine Act) regarding payments between pharmaceutical companies and healthcare professionals.

Our drug candidates contain cannabinoid and psychedelic substances,
the use of which may generate public controversy. Adverse publicity or public perception regarding our current or future drug candidates
may negatively influence the success of these therapies.

Our drug candidates contain cannabinoid and psychedelic
substances that may generate public controversy. Political and social pressures and adverse publicity could lead to delays in approval
of, and increased expenses for our current drug candidates and any future drug candidates we may develop. Opponents of these compounds
may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative
publicity in an effort to persuade the medical community to reject these products, if approved. Adverse publicity from misuse may adversely
affect the commercial success or market