Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 9

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 9
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  the advantages of the treatment compared  

  the number of competitors approved for similar  

  the relative promotional effort and marketing    

  how the product is positioned in physician  

  the prevalence and severity of any side  

  the efficacy and safety of the product;  

  our ability to offer the product for sale  

  the product’s tolerability, convenience                         

  the willingness of the target patient population      

  limitations or warnings, including use restrictions,  

  the strength of sales, marketing and distribution  

  the timing of market introduction of our            

  adverse publicity about the product or favorable  

  potential product liability claims;  

6

  changes in the standard of care for the   
  targeted indications of the product; and  
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  availability and amount of coverage and                                                 

In addition, the potential market opportunities for APHEXDA and
any other therapeutic are difficult to estimate precisely. Our estimates of the potential market opportunities are predicated on many
assumptions, including industry knowledge and publications, third-party research reports and other surveys. While we believe that our
internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are
inherently uncertain and the reasonableness of these assumptions has not been assessed by an independent source. If any of the assumptions
prove to be inaccurate, the actual markets for our therapeutic candidate could be smaller than our estimates of the potential market opportunities.

Even if a therapeutic candidate
receives marketing approval, we or others may later discover that the product is less effective than previously believed or causes undesirable
side effects that were not previously identified, which could compromise our ability or that of any collaborators to market the product,
and could cause regulatory authorities to take certain regulatory actions.

It is possible that our clinical trials may indicate an apparent
positive effect of a therapeutic candidate that is greater than the actual positive effect, if any, or alternatively fail to identify
undesirable side effects. For example, despite the recent FDA marketing approval of APHEXDA in the United States, we, or others, including
our licensees, may discover that APHEXDA is less effective or tolerable than previously believed. If we, or others, discover that a product
is less effective than previously believed or causes undesirable side effects that were not previously identified, any of the following
adverse events could occur:

  regulatory authorities may withdraw their      
  approval of the product or seize the product;  
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