Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 4

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 3
Chunk 4
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 (“FDA”) approved treatments for the same indications, we are also aware of several additional investigational agents and technologies that are currently being studied for the treatment of MM, any of which may compete with DARZALEX in the future. If J& J is unable to successfully compete with these or other agents and technologies, DARZALEX sales could decline materially.

Future prospects for daratumumab are subject to the risks outlined below with respect to our other product candidates, including risks related to clinical trials, adverse events, regulatory requirements and approvals, intellectual property matters, competition, manufacturing, pricing, reimbursement and marketing. In addition, future prospects for daratumumab are also subject to the risk that we will be unable to successfully manage our relationship with J& J and other risks described herein that are applicable to all our collaborations.

Our launch of a new product or of an existing product in a new indication or territory is subject to a number of risks and uncertainties and may not be successful.

We are continuing to expand our commercialization capabilities, including sales, distribution and marketing, to allow us to market our own products for the indications and in the geographies we determine would be most effective to

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create value for patients and our shareholders. The continued commercialization of our existing products could be impaired, and the launch and commercialization of any future products could be delayed or impaired, due to a variety of factors, including supply constraints, delays or challenges in arranging a commercial infrastructure, delays in obtaining or failure to obtain pricing and reimbursement approvals, or other factors, including those described elsewhere herein.

We continue to grow our market-based commercialization operations in existing and additional new markets. Building comprehensive commercialization capabilities requires substantial investment of time and money and significant management focus and resources. We are competing with pharmaceutical and biotechnology companies with established commercialization and marketing capabilities. Without appropriate leveraging of our internal existing team or the support of third parties, we may be unable to compete successfully against these more established companies as we expand into new territories. In addition, we may be unable to develop productive relationships with local medical experts, patients and other key stakeholders or may face barriers due to cultural or regulatory differences. We also compete for staffing with transnational and local pharmaceutical and biotechnology firms and local medical, healthcare and research organizations. Accordingly, there can be no assurance that our efforts to build and expand comprehensive commercialization capabilities will be successful in an acceptable time frame, without disproportionately substantial expenses or at all.

Even if more of our proprietary product candidates obtains regulatory approval,