Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 21

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 21
---
, convenience, price, the level of proprietary
and generic competition, and the availability of coverage and reimbursement from government and other third‑party payors. APHEXDA
sales will suffer, or the commercial opportunity may be reduced or eliminated if competitors develop and commercialize products that are
safer or more effective, have fewer or less severe side effects, or are more convenient or less expensive than any products that we may
develop. Competitors may also obtain FDA or other regulatory approval for their therapeutic candidates more rapidly than we or our licensees
may be able to do so for any existing or new therapeutic candidates of ours, which could result in their establishing a strong market
position before we are able to enter the market.

Mergers and acquisitions in the biotechnology and pharmaceutical
industries may result in even more resources being concentrated in favor of our competitors. Additionally, many competitors have greater
experience in product discovery and development, obtaining FDA and other regulatory approvals and commercialization capabilities, which
may provide them with a competitive advantage. If we or our licensees are not able to compete effectively, our business will not grow
and our financial condition and operations will suffer.

An important element of our strategy for identifying future products
is maintaining relationships with universities, medical institutions and biotechnology companies in order to in-license potential therapeutic
candidates, and we compete with respect to this in-licensing with a number of global pharmaceutical companies. The presence of these global
companies with significantly greater resources than we have may increase the competition with respect to the in-licensing of promising
therapeutic candidates. Our failure to license or otherwise acquire necessary technologies could materially and adversely affect our business,
financial condition and results of operations.

APHEXDA, or any other therapeutic
candidate that we or our licensees are able to commercialize, may become subject to unfavorable pricing regulations, third-party payor
reimbursement practices or healthcare reform initiatives, any of which could harm our business.

The commercial success of APHEXDA and any other therapeutic candidate
will depend substantially, both domestically and abroad, on the extent to which product costs will be paid by third-party payors, including
government health care programs and private health insurers. There is significant uncertainty related to third-party payor coverage and
reimbursement of newly approved drugs. Marketing approvals, pricing and reimbursement for new drug products vary widely from country to
country. Some countries require approval of the sale price of a drug before it can be marketed. In many countries,