Company: PRTA
Filing Date: 2025-08-04
Form Type: 10-Q
Source: 0001559053-25-000031
Chunk: 75

Company: PROTHENA CORP PUBLIC LTD CO
Filing Date: 2025-08-04
Form: 10-Q
Item: Part II, Item 1A
Chunk 75
---
 granted. As a result, we or our collaborators might obtain marketing approval for a drug in a particular country, but then be subject to price regulations that delay commercial launch of the drug, possibly for lengthy time periods, and negatively impact our ability to generate revenue from the sale of the drug in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more drug candidates, even if our drug candidates obtain marketing approval.

U. S. and other governments continue to propose and pass legislation designed to reduce the cost of healthcare. In the U. S., we expect that there will continue to be federal and state proposals to implement similar governmental controls. In addition, recent changes in the Medicare program and increasing emphasis on managed care in the U. S. will continue to put pressure on pharmaceutical product pricing. For example, in 2010, the U. S. Patient Protection and Affordable Care Act, as amended by the U. S. Health Care and Education Reconciliation Act (collectively, the “ ACA”), was enacted. The ACA

substantially changed the way healthcare is financed by both governmental and private insurers and significantly affects the pharmaceutical industry. Among the provisions of the ACA of importance to the pharmaceutical industry are the following:

• an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;

• an increase in the minimum rebates a manufacturer must pay under the U. S. Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively;

• expansion of healthcare fraud and abuse laws, including the U. S. False Claims Act (“ FCA”) and the U. S. Anti-Kickback Statute, new government investigative powers and enhanced penalties for non-compliance;

• extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

• expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;

• a licensure framework for follow-on biologic products;

• expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

• implementation of the federal Physician Payments Sunshine Act, which requires pharmaceutical