Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 21

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 3
Chunk 21
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In addition, our and our collaboration partners’ clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number

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and types of patients available for our and our collaboration partners’ clinical trials. We expect that we and our collaboration partners will conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our and our collaboration partners’ clinical trials at such clinical trial sites. Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to only use conventional therapies, such as chemotherapy and radiation, rather than enroll patients in any future clinical trial.

Even if we and our collaboration partners are able to enroll a sufficient number of patients in our clinical trials, delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our and our collaboration partners’ ability to advance the development of our product candidates.

Any approval granted for our products or product candidates in the U. S. does not assure approval of such products in Japan, the EU or other foreign jurisdictions.

In order to market and sell our drugs in Japan, the EU and other jurisdictions, we and our collaboration partners must obtain separate marketing approvals, and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The marketing approval process outside the U. S. generally includes all of the risks associated with obtaining FDA approval. In addition, many countries outside the U. S. require that the drug be approved for reimbursement before the drug can be approved for sale in that country. We and our collaboration partners may not obtain approvals from regulatory authorities outside the U. S. on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside of the U. S. does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

We may fail to obtain designations for expedited development or review or such designations may not lead to a faster development or regulatory review. Acceptance into an expedited review program or receipt of accelerated approvals does not assure ultimate full regulatory approval.

Fast Track Designation (“ FTD”), Break