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

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 3
Chunk 12
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 or to commercialize such product candidate being tested in such trials.

We rely on a limited number of third-party manufacturers for our product supply.

To ultimately be successful, our antibody products must be manufactured in commercial quantities in compliance with regulatory requirements and at acceptable costs. J& J is responsible for the manufacture of daratumumab, amivantamab, teclistamab and talquetamab. Novartis International AG (“ Novartis”) is responsible for the manufacture of ofatumumab, Amgen Inc. (“ Amgen”) is responsible for the manufacture of teprotumumab, AbbVie is responsible for the manufacturing of epcoritamab, and Pfizer Inc. (“ Pfizer”) is responsible for the manufacturing of tisotumab vedotin.

For the product candidates we are entirely responsible for manufacturing, we currently rely on a limited number of CMOs and specific sites at those CMOs to manufacture and supply large quantities of our product candidates. We expect to negotiate contracts for commercial production on a product-by-product basis for products that we choose to commercialize on terms that make us responsible for manufacturing.

We are aware of only a limited number of companies on a worldwide basis that operate manufacturing facilities in which our product candidates can be manufactured under cGMP regulations. It would take a substantial period of time for a contract facility that has not been producing antibodies to begin producing antibodies under cGMP. We cannot be certain that we will be able to contract with any of these companies on acceptable terms, if at all. New suppliers would also need to have sufficient rights under applicable intellectual property laws to the method of manufacturing such ingredients. In addition, significant cancellation penalties and the long lead times required for initial orders or to make any changes to existing orders, including changing the scale of production, limit our flexibility in connection with product development, clinical trials or commercial sales. For example, we may be required to order products for the

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second part of a clinical trial or for a proposed follow-on clinical trial before we have initial results from the trial, which could result in a loss if we terminate the trial or need to make changes to the product.

We could also encounter difficulties, delays or inefficiencies in our supply chain, product manufacturing and distribution networks, as well as sales or marketing, due to regulatory actions, shut-downs, work stoppages or strikes, approval delays, withdrawals, recalls, penalties, supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely