Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 26

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 26
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 policies designed to reduce healthcare
costs. These changes frequently adversely affect pricing and profitability and may cause delays in market entry. We cannot predict which
additional measures may be adopted or the impact of current and additional measures on the marketing, pricing and demand for our approved
products, if any of our therapeutic products are approved.

16

Significant developments that may adversely affect pricing in the
United States include (i) the enactment of federal healthcare reform laws and regulations, including the Medicare Prescription Drug Improvement
and Modernization Act of 2003 and the ACA, and (ii) trends in the practices of managed care groups and institutional and governmental
purchasers, including the impact of consolidation of our customers. In 2022, the IRA, established the Medicare Drug Price Negotiation
Program which permits the government to negotiate “maximum fair” drug prices for certain high expenditure, single source drugs
and biologics. It is estimated that over the next seven years, 60 drugs covered under Medicare B and D will have negotiated a “maximum
fair price.”

Changes to the healthcare system enacted as part of healthcare
reform in the United States, as well as the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and
private sector beneficiaries, may result in increased pricing pressure by influencing, for instance, the reimbursement policies of third-party
payors. Healthcare reform legislation has increased the number of patients who would have insurance coverage for our approved products,
if any of our therapeutic products are approved, but provisions such as the assessment of a branded pharmaceutical manufacturer fee and
an increase in the amount of the rebates that manufacturers pay for coverage of their drugs by Medicaid programs may have an adverse effect
on us. It is uncertain how current and future reforms in these areas will influence the future of our business operations and financial
condition, as federal, state and foreign governmental authorities are likely to continue efforts to control the price of drugs and reduce
overall healthcare costs. These efforts could have an adverse impact on our ability to market products and generate revenues in the United
States and foreign countries.

If third-party payors do
not adequately reimburse customers for any of our therapeutic candidates that are approved for marketing, they might not be purchased
or used, and our revenues and profits will not develop or increase.

Our revenues and profits will depend heavily upon the availability
of adequate reimbursement for the use of our approved candidates, if any, from governmental or other third-party payors, both in the United
States and in foreign markets