Genmab (GMAB) investor relations material

Key pipeline milestones and outlook

• Three late-stage assets—EPKINLY, Rina-S, and petosemtamab—each have FDA Breakthrough Therapy Designation and are expected to deliver potentially registrational readouts in 2026, with possible launches in 2027 for Rina-S and petosemtamab.

• EPKINLY is positioned for material line extensions into earlier lines of DLBCL, with upcoming readouts in both second-line and frontline settings; primary endpoints focus on PFS, not overall survival.

• Rina-S is advancing in platinum-resistant ovarian and endometrial cancers, with robust efficacy across expression levels and a phase II readout expected in H2; phase III trials are fully recruited.

• Petosemtamab is progressing in head and neck cancer, with phase IIIs expected to read out in H2; prior data showed a strong response rate and rapid onset of action in combination with pembrolizumab.

• Expansion opportunities and additional indications are being pursued for all three assets, with a focus on best-in-class, first-in-class, and broadest-in-class positioning.

Commercial and operational strategy

• Commercial potential for EPKINLY could expand to 90,000–100,000 more patients if approved for earlier lines, with frontline representing about half the brand's value.

• Rina-S and petosemtamab are expected to be multi-billion dollar brands, with Rina-S targeting a combined ovarian and endometrial cancer population of around 120,000 patients.

• Distribution strategy includes direct commercialization in key markets (US, Japan, major EU countries) and partnerships or distributorships elsewhere, leveraging proven launch capabilities.

• Expansion beyond academic centers is underway, increasing access and convenience for patients in community settings.

• Operational expenditure guidance remains unchanged, with confidence in scaling the business as new products launch.

Financial outlook and growth prospects

• Peak year sales estimates: EPKINLY $3B+, Rina-S $2B+, petosemtamab multi-billion; these are underpinned by current clinical plans.

• Growth is expected to continue even as DARZALEX royalties phase out, supported by a strong proprietary pipeline and ongoing royalty streams from other products.

• Internal R&D is expected to yield additional late-stage assets by 2027–2029, further supporting long-term growth into the 2030s.