Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 3

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 3
Chunk 3
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 revenue and resulting operating profit and near-term prospects are substantially dependent on J& J’s efforts and the success of this collaboration.

The royalties payable to us by J& J are limited in time and subject to reduction on a country-by-country basis for customary reduction events, including for lack of patent coverage or upon patent expiration or invalidation in the relevant country and upon the first commercial sale of a biosimilar product in the relevant country (for as long as the biosimilar product remains for sale in that country). Pursuant to the terms of the agreement, J& J’s obligation to pay royalties to us will expire on a country-by-country basis on the later of the date that is 13 years after the first sale of daratumumab in such country or upon the expiration or invalidation of the last-to-expire relevant Genmab patent covering daratumumab in such country. The first U. S., European and Japanese sales of daratumumab occurred in 2015, 2016 and 2017, respectively.

We have issued patents and pending patent applications covering daratumumab in numerous jurisdictions, including patents issued in the U. S., Europe and Japan. J& J owns a separate patent portfolio related to the subcutaneous formulation of daratumumab used in DARZALEX FASPRO/DARZALEX SC, but a binding arbitration determined that we are not entitled to royalties based on these separate patents.

Our issued U. S., European and Japanese patents covering daratumumab, after giving effect to issued U. S., European and Japanese patent term extensions (“ PTEs”) and supplementary protection certificates (“ SPCs”), expire in 2029, 2031 and begin to expire in 2030, respectively. Assuming constant underlying sales of DARZALEX, we expect that our royalties from sales of DARZALEX will begin to decline materially in 2029 following expiration of our U. S. patent rights on daratumumab. There can be no assurance that we will be able to replace all or any portion of lost DARZALEX royalty revenues through development and commercialization of other products or through acquisitions in a timely manner or at all.

In addition, there can be no assurance that DARZALEX sales will remain at or near current levels or will continue to grow while we remain entitled to royalites. In particular, DARZALEX is subject to intense competition in the MM therapy market. In addition to numerous other U. S Food and Drug Administration