Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 100

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 100
---
 U.S. biopharmaceutical industry, including permitting the Centers for Medicare and Medicaid Services (the “CMS”),
for the first time, to negotiate prices with pharmaceutical companies for selected drugs.

Many legislative and regulatory proposals have sought to reduce drug
prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic
and biosimilar drugs. These legislature and regulatory changes may significantly adversely impact our business and profitability.

The IRA was passed on August 16, 2022 and, among other things,
allows for CMS to negotiate prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D,
beginning with ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by up to 15 Part D drugs in
2027, up to 15 Part B or Part D drugs in 2028, and up to 20 Part B or Part D drugs in 2029 and beyond. The legislation
subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering
a price that is not equal to or less than the negotiated “maximum fair price” under the law or for taking price increases
that exceed inflation. The legislation also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000. The
effect of the IRA on our business and the healthcare industry in general is not yet known. We cannot predict how CMS will interpret the
IRA or how the provisions of the law will affect our business once fully implemented.

52

At the state level, legislatures are increasingly passing legislation
and implementing regulations designed to control pharmaceutical and biologic product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, requirements for
substitution of generic products, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

These laws, and future state and federal healthcare reform measures
that may be adopted in the future, could adversely affect the prices we may obtain for any of our product candidates or the frequency
with which any such product candidate is prescribed or used. We expect to experience pricing pressures in connection with the sale of
any future approved product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations,
cost containment initiatives and additional legislative changes, all of which may adversely affect