Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 102

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 102
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other comparable regulatory approvals. Nonetheless, product candidates may not be considered medically necessary or cost effective in
light of cost-benefit analysis. Additionally, a payor’s decision to provide coverage for a drug product does not imply that an adequate
reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug product does not assure that
other payors will also provide coverage for the drug product. Third-party reimbursement may not be sufficient to maintain price levels
high enough to realize an appropriate return on investment in product development.

The containment of healthcare costs also has become a priority
of federal, state and foreign governments and the prices of drugs have been a focus in this effort. Governments have shown significant
interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution
of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions
with existing controls and measures, could further limit our net revenue and results. Coverage policies and third-party reimbursement
rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which a company
or its collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Outside the United States, ensuring adequate coverage and payment
for our therapeutic candidates will face challenges. Pricing of prescription pharmaceuticals is subject to governmental control in many
countries. Pricing negotiations with governmental authorities can extend well beyond the receipt of regulatory marketing approval for
a product and may require us to conduct studies that compare the cost effectiveness of our product candidates or products to other available
therapies. The conduct of such studies could be expensive and result in delays in our commercialization efforts.

Pricing and reimbursement schemes vary widely from country to country.
Some countries provide that drug products may be marketed only after a reimbursement price has been agreed. Some countries may require
the completion of additional studies that compare the cost-effectiveness of a particular drug candidate to currently available therapies
in order to obtain reimbursement. For example, the European Union provides options for its member states to restrict the range of drug
products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human
use. European Union member states may approve a specific price for a drug product, or it may instead adopt a system of direct or indirect
controls on the profitability of the company placing the drug product on the market. Other member states allow companies to fix their