Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 146

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 146
---
 product candidate to currently available therapies. A member state may approve a specific price for the medicinal
product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product
on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products
will allow favorable reimbursement and pricing arrangements for any of our product candidates. Historically, products launched in the
EU do not follow price structures of the U.S. and generally prices tend to be significantly lower.

Healthcare Reform

Payors, whether domestic or foreign, or governmental
or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically
adapted for therapies addressing rare diseases such as those we are developing. In both the United States and certain foreign jurisdictions,
there have been a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell our product
candidates profitably if and when approved for marketing. In particular, in 2010, the ACA was enacted, which, among other things, subjected
biologic products to potential competition by lower-cost biosimilars; addressed a new methodology by which rebates owed by manufacturers
under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased
the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program
to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual
fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in which manufacturers
must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage
gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. More generally, the
ACA expanded healthcare coverage through Medicaid expansion and the implementation of the “individual mandate” for health
insurance coverage.

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Beyond the ACA, there have been ongoing healthcare
reform efforts. Drug pricing and payment reform was a focus of the Trump administration and has been a focus of the Biden administration.
For example, federal legislation enacted in 2021 eliminates the statutory cap on Medicaid drug rebate program rebates (currently set
at 100% of a drug’s “average manufacturer price”), effective January 1, 2024. As another example, the IRA,