Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 48

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 48
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, state legislatures and foreign governments have continued implementing cost containment programs, including
price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls
and cost containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could
further limit our net revenue and results. We may need to conduct expensive clinical studies to demonstrate the comparative cost-effectiveness
of our products. The product candidates that we develop may not be considered cost-effective and thus may not be covered or sufficiently
reimbursed. It is time consuming and expensive for us to seek coverage and reimbursement from third-party payors, as each payor will
make its own determination as to whether to cover a product and at what level of reimbursement. Thus, one payor’s decision to provide
coverage and adequate reimbursement for a product does not assure that another payor will provide coverage or that the reimbursement
levels will be adequate. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement
rate will be approved. Reimbursement may not be available or sufficient to allow us to sell our products on a competitive and profitable
basis.

Healthcare
Reform 

In
the United States and foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding
the healthcare system that could prevent or delay marketing approval of our investigational medicines, restrict or regulate post-approval
activities and affect our ability to profitably sell any approved products. The ACA, for example, contains provisions that subject biological
products to potential competition by lower-cost biosimilars and may reduce the profitability of drug products through increased rebates
for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain
Medicare Part D beneficiaries and, annual fees based on pharmaceutical companies’ share of sales to federal health care programs.
Current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria
and in additional downward pressure on the price for any approved products.

In
the United States, it is unclear whether the ACA will be overturned or further amended. We cannot predict what effect further changes
to the ACA would have on our business. Additionally, other federal health reform measures have been proposed and adopted in the United
States since the ACA was enacted, including the Budget Control Act of 2011, which includes provisions to reduce the federal deficit. The