Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 8

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 8
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5

Our revenues from motixafortide or any product candidate for which
regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory
approval, the accepted price for the product, the ability to get reimbursement at any price, and the terms and conditions of our commercialization
agreement with our partner for that territory. While we retain the right to potentially meaningful milestones or royalty payments under
the Gloria License Agreement and the Ayrmid License Agreement, it could take many years before such milestones are achieved, resulting
in such royalty payments being made, if at all.

The timing and amount of any milestone and royalty payments we
may receive from our licensees, as well as the commercial success of our products will depend on, among other things, the efforts, allocation
of resources, negotiation of pricing and reimbursement and successful commercialization of our products by our licensees. As a result,
even if we generate product revenues, we may not become profitable and may need to obtain additional funding to continue operations.

APHEXDA, or any other therapeutic
candidate that may receive approval to sell the product in the future, may fail to achieve the degree of market acceptance by physicians,
patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for APHEXDA
or any other therapeutic candidate may be smaller than our estimates.

APHEXDA or any other therapeutic candidate that may be approved
in the future by the appropriate regulatory authorities for marketing and sale, may fail to gain sufficient market acceptance by physicians,
patients, third-party payors and others in the medical community. Physicians are often reluctant to switch their patients from existing
therapies even when new and potentially more effective or convenient treatments enter the market. APHEXDA competes with the standard of
care using stem cell mobilization and its generic versions.

Efforts to educate the medical community and third-party payors
on the benefits of APHEXDA over its competition have required significant resources and may not ultimately be successful. If APHEXDA,
or any other therapeutic candidate that may be approved in the future for marketing and sale in the future, does not achieve an adequate
level of market acceptance, we may not generate significant revenues and we may not become profitable. The degree of market acceptance
of APHEXDA, or any other therapeutic candidate that may be approved in the future, will depend on a number of factors, including: