Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 77

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 77
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 under the Medicaid Drug Rebate Program by increasing the minimum rebate amount for both branded and generic drugs and revised
the definition of “average manufacturer price,” or AMP, which may also increase the amount of Medicaid drug rebates manufacturers
are required to pay to states. The legislation also expanded Medicaid drug rebates and created an alternative rebate formula for certain
new formulations of certain existing products that is intended to increase the rebates due on those drugs. The Centers for Medicare &
Medicaid Services, or CMS, which administers the Medicaid Drug Rebate Program, also has proposed to expand Medicaid rebates to the utilization
that occurs in the territories of the U.S., such as Puerto Rico and the Virgin Islands. Further, beginning in 2011, the PPACA imposed
a significant annual fee on companies that manufacture or import branded prescription drug products and required manufacturers to provide
a discount, equal to 70% off, effective as of 2019, the negotiated price of prescriptions filled by beneficiaries in the Medicare Part
D coverage gap, referred to as the “donut hole.” Legislative and regulatory proposals have been introduced at both the state
and federal level to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

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Moreover, payment methodologies
may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery
models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in which
manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted
federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription
drugs under government payor programs, and review the relationship between pricing and manufacturer patient programs. We also expect that
additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal
government will pay for healthcare products and services, which could result in reduced demand for our drug candidates, if approved for
commercialization.

In Europe, the United Kingdom
withdrew from the European Union on January 31, 2020, and entered into a transition period that expired on December 31, 2020. A significant
portion of the previous regulatory framework in the United Kingdom was derived from the regulations of the European Union. In 2021, the
United Kingdom’s Medicines and Healthcare products Regulatory Agency