Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 110

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 110
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, which President Trump signed into law
in July 2025, modified the IRA’s exclusion protecting orphan drugs designated for a single rare disease indication from required
pricing negotiations by expanding it to apply to drugs designated for multiple rare diseases and by prohibiting Medicare price negotiations
until seven years after an orphan drug, or 11 years after an orphan biologic, is approved for a non-orphan indication, which will significantly
delay pricing negotiations for certain high-priced and widely used drugs.

At the state level, legislatures are increasingly
passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or
patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures,
and, in some cases, designed to encourage importation from other countries and bulk purchasing. In December 2020, the U.S. Supreme Court
held unanimously that federal law does not preempt the states’ ability to regulate pharmacy benefit managers (“PBMs”),
and other members of the healthcare and pharmaceutical supply chain, an important decision that has led to more aggressive efforts by
states in this area. The Federal Trade Commission (“FTC”) in mid-2022 also 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. Numerous PBM reforms are being considered in both the Senate and the House of
Representatives, including diverse legislative proposals such as eliminating rebates; divorcing service fees from the price of a drug,
discount, or rebate; prohibiting spread pricing; limiting administrative fees; requiring PBMs to report formulary placement rationale;
promoting transparency. Significant efforts to change the PBM industry as it currently exists in the U.S. may affect the entire pharmaceutical
supply chain and the business of other stakeholders, including pharmaceutical developers like us. In addition, regional healthcare authorities
and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products, and which suppliers will
be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our products or put pressure
on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.

In the European Union and the United Kingdom, similar
political, economic and regulatory developments may affect our ability to profitably commercialize any of our drug candidates, if approved.
In addition to continuing pressure on prices and cost containment measures, legislative developments in the United Kingdom or at the European
Union