Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 22

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 22
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 the pricing review
period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains
subject to continuing governmental control even after initial approval is granted. As a result, we or our licensees might obtain marketing
approval for a product in a particular country but then be subject to price regulations that delay commercial launch of the product, possibly
for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale of the product in that country.
Adverse pricing limitations may hinder our ability to recoup our or their investment in one or more therapeutic candidates, even if our
therapeutic candidates obtain marketing approval.

Patients who are provided with medical treatment for their conditions
generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Therefore, our ability, and
the ability of any licensees to successfully commercialize any of our therapeutic candidates will depend in part on the extent to which
coverage and adequate reimbursement for these products and related treatments will be available from third-party payors. Third-party payors
decide which medications they will cover and establish reimbursement levels. The healthcare industry is acutely focused on cost containment,
both in the United States and elsewhere. Government authorities and other third-party payors have attempted to control costs by limiting
coverage and the amount of reimbursement for particular medications, which could affect our ability to sell APHEXDA profitably. These
payors may not view APHEXDA as cost-effective, and coverage and reimbursement may not be available to customers or may not be sufficient
to allow our products to be marketed on a competitive basis. Cost-control initiatives could cause us or our licensees to decrease the
price we might establish, which could result in lower than anticipated product revenues. If the prices for our products, if any, decrease
or if governmental and other third-party payors do not provide coverage or adequate reimbursement, our prospects for revenue and profitability
will suffer.

14

There may also be delays in obtaining coverage and reimbursement
for newly approved drugs, such as APHEXDA, and coverage may be more limited for APHEXDA than for other drug products with similar indications
approved by the FDA or comparable foreign regulatory authorities. Moreover, eligibility for reimbursement does not imply that any therapeutic
will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution.
Reimbursement rates may vary, for example, according to the use