Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 23

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 23
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 of the product and the clinical setting in which it is used. Reimbursement
rates may also be based on reimbursement levels already set for lower cost treatments or may be incorporated into existing payments for
other services.

In addition, increasingly, third-party payors are requiring higher
levels of evidence of the benefits and clinical outcomes of new technologies and are challenging the prices charged. We cannot be sure
that coverage will be available for any therapeutic candidate that we, or third parties, commercialize and, if available, that the reimbursement
rates will be adequate. Further, the net reimbursement for products may be subject to additional reductions if there are changes to laws
that presently restrict imports of products from countries where they may be sold at lower prices than in the United States. An inability
to promptly obtain coverage and adequate payment rates from both government-funded and private payors for any therapeutic candidate for
which we obtain regulatory approval could significantly harm our operating results and our overall financial condition.

We rely upon third-party
manufacturers to produce therapeutic supplies of motixafortide. If we manufacture any therapeutic candidates in the future, we will be
required to incur significant costs and devote significant efforts to establish and maintain manufacturing capabilities.

We do not currently have laboratories that are compliant with cGMP
and therefore cannot independently manufacture drug products for our current clinical trials or commercialization. We rely on third-party
manufacturers to produce the therapeutic supplies that enable us to perform clinical trials and supply commercial scale product. We have
limited personnel with experience in drug product manufacturing and we lack the resources and capabilities to manufacture any of our therapeutic
candidates on a commercial scale. The manufacture of pharmaceutical products requires significant expertise and capital investment, including
the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties
in production, particularly in scaling up initial production. These problems include difficulties with production costs and yields and
quality control, including stability of the therapeutic candidate.

We do not currently have any long-term agreements with third-party
manufacturers that guarantee the supply of therapeutic supplies and we rely on single source suppliers. When we require additional supplies
to complete our clinical trials or for commercialization, we may be unable to enter into agreements for clinical or commercial supply,
as applicable, with third-party manufacturers, or may be unable to do so on acceptable terms.

Reliance on third-party manufacturers entails risks to which we
would not be subject if we manufactured therapeutic candidates ourselves, including:

  reliance on the third party for regulatory  

  limitations on supply availability