Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 44

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 44
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ALVEY, which are handled by J&J; Kesimpta, handled by Novartis; and TEPEZZA, handled by Amgen, under the applicable agreements. Our partners Pfizer and AbbVie are responsible for the manufacturing processes for Tivdak and EPKINLY/TEPKINLY, respectively, under the applicable agreements. 
Currently, the majority of the products required for our clinical trials and pre-clinical trials are manufactured by a limited number of CMOs and specific sites at those CMOs. In addition, we rely on other third parties to perform additional steps in the manufacturing process, as well as analysis, shipping and storage of drug products and our product candidates. Although we rely on our cGMP manufacturers and suppliers, we have personnel with substantial manufacturing and production experience to oversee our relationships with such manufacturers and suppliers and provide the necessary technical, quality and regulatory oversight of our CMOs. We have also adopted procedures to promote compliance by our CMOs with relevant regulatory requirements and internal guidelines with respect to production qualifications, facilities and processes.
We believe our CMOs are, and any future CMOs will be, capable of producing sufficient quantities of drug products to support our currently planned commercialization, clinical trials and pre-clinical trials. We also believe that, while limited, there are alternative third-party manufacturers that have similar capabilities that would be capable of providing 

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sufficient quantities of commercial products and drug products for our planned clinical trials and pre-clinical trials. However, should our CMOs not be able to provide sufficient quantities of commercial products or drug product for our planned commercialization, clinical trials or pre-clinical trials, we would be required to seek other CMOs to provide this product, potentially resulting in a delay in such trials or delivery of our commercialized products.
Raw Materials
We currently rely on a third-party manufacturer for raw materials. Raw materials are available in quantities adequate to meet the needs of our business. The prices of the raw materials are subject to a service agreement. While we do not anticipate any significant price volatility, to the extent that we are exposed to price fluctuations, we expect the fluctuations to occur within a limited range and not have a material impact on our business, financial condition, liquidity, or operating results. 
Commercialization Strategy
Our approved products in development with collaboration partners are DARZALEX, RYBREVANT, TECVAYLI, and TALVEY marketed by J&J