Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 1

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 1
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Item 3       Key information

A.     Reserved

B.     Capitalization and indebtedness
Not applicable.

C.     Reasons for the offer and use of proceeds
Not applicable. 

D.     Risk factors
Our business is subject to significant risks. You should carefully consider all of the information set forth in this annual report and in our other filings with the U.S. Securities and Exchange Commission, or the SEC, including the following risk factors which we face, and which are faced by our industry. Our business, financial condition, or results of operations could be materially adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the risks described below and elsewhere in this annual report and our other SEC filings. See “Special Note Regarding Forward-Looking Statements” above.
Risks related to product development and regulatory approval
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We are dependent on the success of our clinical-stage product candidates, including our oncology candidates (such as GLPG5101, and GLPG5301) and our immunology candidates (such as GLPG3667). We cannot give any assurance that any product candidate will complete clinical trials successfully or receive regulatory approval, which is necessary before it can be commercialized.
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Our business and future success is substantially dependent on our ability to develop successfully, obtain regulatory approval for, and then successfully commercialize our clinical-stage oncology and immunology product candidates, including GLPG5101, GLPG5301 and GLPG3667.
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4

Our product candidates will require additional clinical development, management of clinical and manufacturing activities, regulatory approval in multiple jurisdictions (if regulatory approval can be obtained at all), securing sources of commercial manufacturing supply, building of, or partnering with, a commercial organization, substantial investment and significant marketing, sales and distribution efforts before any revenues can be generated from product sales. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA, the EMA, the Medicines and Healthcare products Regulatory Agency (the “MHRA”), or any other comparable regulatory authority such as the Ministry of Health, Labour and Welfare in Japan (the “MHLW)/Pharmaceuticals and Medical Devices Agency in Japan (the “PMDA), and we may never receive such regulatory approval for any of our product candidates. We cannot assure you that our clinical trials for GLPG510