Genmab (GMAB) investor relations material

Key clinical development updates

• Three major late-stage assets—EPKINLY, Rina-S, and petosemtamab—have pivotal phase III readouts expected in Q4 2026, with potential to be first-in-class in their indications.

• Rina-S has five active phase III trials across ovarian and endometrial cancers, with the first readout in Q4 and additional signal-seeking studies in lung and GI tumors.

• Petosemtamab development expanded post-acquisition, with amended trial sizes and new phase III trials in colorectal cancer, plus plans for a locally advanced head and neck cancer trial by year-end.

• EPKINLY's frontline DLBCL phase III readout is scheduled for Q4, with confidence based on prior phase II/III data consistency.

• Data from petosemtamab in colorectal cancer will be presented at ESMO in October, supporting the decision to initiate phase III trials.

Competitive positioning and strategy

• Petosemtamab is positioned ahead of competitors in frontline head and neck cancer, with confidence in efficacy and safety versus Bicara and J&J's RYBREVANT.

• Rina-S aims to be first and broadest in the GYN oncology space, with a differentiated program including endometrial cancer, outpacing competitors like Eli Lilly, AstraZeneca, GSK, and Gilead.

• The company is leveraging early and robust data to inform trial expansion and maintain a competitive edge, especially in rapidly evolving markets.

• Multi-billion dollar peak sales potential is guided, with updates contingent on further clinical data, especially for new indications.

• The business model is evolving to integrate proprietary oncology launches with a strong royalty portfolio, supporting growth through and beyond DARZALEX LOE.

Commercialization and financial outlook

• Preparations are underway for the launch of Rina-S and petosemtamab in 2027, with confidence in commercial readiness and infrastructure.

• Additional investments in SG&A and R&D are planned to support broader development and upcoming launches.

• Amortization of acquisition costs for petosemtamab and Rina-S will begin upon launch, with DKK 7 billion and DKK 1+ billion to be amortized, respectively.

• The company expects to launch all three late-stage assets in 2027, with timelines dependent on regulatory review speed.

• Consensus estimates may need to adjust for new trial initiations and expanded development programs.