Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 148

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 148
---
 example, revisions to regulations under the federal anti-kickback statute would remove
protection for traditional Medicare Part D discounts offered by pharmaceutical manufacturers to pharmacy benefit managers and health
plans. Pursuant to court order, the removal was delayed and recent legislation imposed a moratorium on implementation of the rule until
January 2032. As another example, the IRA drug price negotiation program has been challenged in litigation filed by various pharmaceutical
manufacturers and industry groups.

There have also been efforts by federal and
state government officials or legislators to implement measures to regulate prices or payment for pharmaceutical products, including
legislation on drug importation. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation
Program (SIP) proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will
be implemented, United States or Canada. Other states have also submitted Section 804 Importation Program (“SIP”) proposals
that are pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products
covered by those programs. Recently, there has been considerable public and government scrutiny of pharmaceutical pricing and proposals
to address the perceived high cost of pharmaceuticals. There have also been recent state legislative efforts to address drug costs, which
generally have focused on increasing transparency around drug costs or limiting drug prices.

General legislative cost control measures
may also affect reimbursement for our product candidates. The Budget Control Act, as amended, resulted in the imposition of reductions
in Medicare (but not Medicaid) payments to providers in 2013 that remain in effect through 2032 unless additional Congressional action
is taken. Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that
may be implemented and/or any significant taxes or fees that may be imposed on us could have an adverse impact on our results of operations.

Adoption of new legislation at the federal
or state level could affect demand for, or pricing of, any future products if approved for sale. We cannot, however, predict the ultimate
content, timing or effect of any federal and state reform efforts. There is no assurance that federal or state healthcare reform will
not adversely affect our future business and financial results.

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Other Healthcare Laws

Pharmaceutical companies are subject to additional
healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they
conduct