Product development, regulatory approval and commercialization

Risks related to product development, regulatory approval and commercialization

The Group operates adequate standard operating procedures to secure the integrity and protection of its research and development activities and results, and the optimum allocation of its R&D budgets. The progress of the most important research and development programs is continuously monitored by the Executive Committee; they are discussed with the Board at least once per quarter, and Board members with expertise in clinical and scientific matters occasionally attend meetings with scientific staff to discuss and assess such programs. Nevertheless, due to Galapagos' limited resources and access to capital, Galapagos must and has in the past decided to prioritize development of certain product candidates; these decisions may prove to have been wrong and may adversely affect its business.

Galapagos is heavily dependent on the success of its product candidate filgotinib and its other product candidates. Galapagos may not be successful in its efforts to use and expand its novel, proprietary target discovery platform to build a pipeline of product candidates.

Galapagos' business and future success is substantially dependent on its ability to develop successfully, obtain regulatory approval for, and then successfully commercialize its product candidate filgotinib and its other product candidates. Galapagos is not permitted to market or promote any of its product candidates before it receives regulatory approval from the FDA, the EMA or any other comparable regulatory authority, and Galapagos may never receive such regulatory approval for any of its product candidates. Galapagos cannot give any assurances that its clinical trials for filgotinib or its other product candidates will be completed in a timely manner, or at all. Galapagos has never completed a Phase 3 trial or submitted an NDA. If filgotinib or any future product candidate is not approved and commercialized, Galapagos will not be able to generate any product revenues for that product candidate.

The regulatory approval processes of the FDA, the EMA and other comparable regulatory authorities are lengthy, time consuming and inherently unpredictable, and if Galapagos is ultimately unable to obtain regulatory approval for its product candidates, its business will be substantially harmed.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Results of earlier studies and trials as well as data from any interim analysis of ongoing clinical trials may not be predictive of future trial results and failure can occur at any time during the clinical trial process. If Galapagos experiences delays in the completion of, or termination of, any clinical trial of its product candidates, the commercial prospects of its product candidates will be harmed, and its ability to generate product revenues from any of these product candidates will be delayed. If filgotinib or any other product candidate is found to be unsafe or lack efficacy, Galapagos will not be able to obtain regulatory approval for it and its business would be materially harmed.

The rates at which Galapagos completes its scientific studies and clinical trials depend on many factors, including, but are not limited to, patient enrolment.

Patient enrolment is a significant factor in the timing of clinical trials and is affected by many factors including competing clinical trials, clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies and the relatively limited number of patients. Any of these occurrences may harm Galapagos' clinical trials and by extension, its business, financial condition and prospects.

Galapagos’ product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.

Undesirable side effects caused by Galapagos’ product candidates could cause Galapagos or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA or other comparable regulatory authorities. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm Galapagos’ business, financial condition and prospects significantly.