Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 191

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 191
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 competing generics or biosimilars. This provision is limited in terms of the number of pharmaceuticals
whose prices can be negotiated in any given year and it only applies to drug products that have been approved for at least 9 years and
biologics that have been licensed for 13 years. Drugs and biologics that have been approved for a single rare disease or condition are
categorically excluded from price negotiation. Further, the new legislation provides that if pharmaceutical companies raise prices in
Medicare faster than the rate of inflation, they must pay rebates back to the government for the difference. The new law also caps Medicare
out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year.

Government regulations could impact
our ability to price our products

U.S. and international governmental
regulations that mandate price controls or limitations on patient access to our drugs under development, create coverage criteria or establish
prices paid by government entities or programs for our potential products could impact our business, and our future results could be adversely
affected by changes in such regulations or policies. In addition to the recent expansion of price controls in the U.S. in the IRA, the
adoption of restrictive coverage policies and price controls in new jurisdictions, more restrictive controls in existing jurisdictions
or the failure to obtain or maintain timely or adequate coverage and pricing could also adversely impact future revenue. We expect pricing
pressures and other cost containment measures for drugs and vaccines will continue globally.

In the U.S., pharmaceutical
product pricing is subject to government and public scrutiny and calls for reform, and many of our products are subject to increasing
pricing pressures as a result. We expect to see continued focus by the U.S. Congress and the Biden Administration on regulating pricing
and access to medicine. For example, in August 2022, the drug pricing provisions of the IRA were signed into law, which, among other things,
require manufacturers of certain drugs to engage in price negotiations with Medicare which will permit the CMS to set a maximum fair price
for selected drugs, impose rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replace
the Part D coverage gap discount program with a new discounting program. The drug pricing provisions of the IRA began to be implemented
in 2022 and implementation efforts are expected to continue over the next several years. In August 2023, the Biden Administration