Genmab A/S Q2 FY2026 earnings call

Core Business Strategy & Financial Discipline

• Management's top priorities remain accelerating late-stage pipeline development, maximizing value from commercialized products, and maintaining disciplined capital allocation
• The company grew total revenue and adjusted operating profit (18% year-over-year growth) while making focused strategic investments in late-stage programs, launch preparation, and Mirans integration
• The revenue base is becoming increasingly diversified and durable, with half of growth coming from new commercial products rather than legacy products, strengthening the quality of the business

Pipeline Clinical Progress

• Announced positive statistically significant and clinically meaningful progression-free survival top-line results from the Phase III APCOR DL-BCL4 trial for apcaritumab, building evidence of apcaritumab combination versatility across multiple lines of therapy
• Received European approval for tepkinli plus lenalidomide and rituximab for second-line follicular lymphoma, making tepkinli the first and only bispecific-based therapy approved in Europe for this indication
• Based on encouraging early clinical data, the company is initiating two new global Phase III trials for pitocentamab (EGFR-LGR5 bispecific antibody) in frontline and second-line RAS/RAF wild-type unresectable/metastatic colorectal cancer, versus current standard of care
• All key late-stage programs remain on track for Phase III readouts in H2 2026, with potential approvals and launches planned for 2027

Commercial Execution

• Epkinley has seen rapid uptake of its chemo-free fixed-duration second-line follicular lymphoma regimen, with most new site activations coming from community practices and over 90% of key customers ordering across two or more sites; it holds dual indication approval for DLBCL and follicular lymphoma without a 24-hour hospitalization requirement
• Recent approvals for Epkinley's second-line follicular lymphoma regimen have been secured in Europe and China via partner AbbVie, with a Japanese second-line launch planned for late 2026 to drive further growth
• TIBDAC secured reimbursement in the UK, with ongoing reimbursement discussions in other new launch markets, and continues to expand site activation globally for advanced cervical cancer
• The company is building out commercial capabilities to support upcoming launches of RINA-S and pitocentamab in 2027

GENMAP's total first half 2026 revenue grew 25% year-over-year, with broad-based growth across its commercial portfolio. Darzalex grew 21% year-over-year and contributed approximately half of the company's total year-over-year revenue growth. The proprietary commercial segment had total sales of $396 million, growing 37% year-over-year, accounting for 50% of year-over-year revenue growth alongside Darzalex. Epkinley generated $312 million in first half sales, growing 48% year-over-year (28% quarter-over-quarter), representing 78.8% of proprietary segment revenue and 312/396 = 78.8% of proprietary sales. TIBDAC generated $84 million in first half sales, growing across the U.S., Japan, and European launch markets, representing 21.2% of proprietary segment revenue. The remainder of the company's portfolio grew 35% year-over-year overall.

• Management has upgraded full-year 2026 financial guidance, now expecting total revenue of $4.3 billion to $4.5 billion, representing 19% year-over-year growth at the midpoint, up from 19% 14% growth expected under prior guidance (a 5% increase to expected revenue at the midpoint) • The midpoint revenue upgrade of $195 million is split approximately equally between stronger-than-expected performance from Darzalex and Epkinley • Operating expense guidance is increased by only 2% to a new midpoint of $2.88 billion, to accommodate incremental investment for the two new pitocentamab Phase III trials announced during the call • Full-year operating profit guidance is upgraded 7% to a range of $1.1 billion to $1.4 billion, with most revenue outperformance translating to higher operating profit while continuing to invest in high-value growth opportunities • The effective tax rate is expected to continue fluctuating during Mirans integration, and will normalize over the next 12 to 18 months

• All forward-looking statements are subject to material risks, including the risk of delayed or unsuccessful clinical development projects, which could cause actual results to differ materially from management expectations • Late-stage trial outcomes are uncertain, and efficacy/safety results may not meet statistical or clinical requirements for approval • Increasing competition in key target indications (including head and neck cancer, colorectal cancer, and ovarian cancer) from competitor products may erode expected market share and commercial opportunity • Uncertainty remains around FDA discussions on which apcaritumab trial will serve as the confirmatory trial for its new indication, with a final decision dependent on upcoming frontline trial results

• Clinical trial readout timelines are subject to change based on event-driven endpoint requirements, which can lead to delays versus initial projections

Q: Why is the pitocentamab second/third line head and cancer trial readout delayed to Q1 2027, and what is the status of overall survival data and FDA confirmatory trial plans for the APCOR DL-BCL4 trial? / A: The delay is solely due to event-driven timing projections for the trial's overall survival endpoint, which is now expected to mature in Q1 2027; the trial is already fully enrolled. Overall survival data for APCOR DL-BCL4 is still too immature to report, and full data will be presented at an upcoming medical conference. Discussions with the FDA are ongoing to determine whether the frontline or second-line trial will serve as the confirmatory study, and a decision will depend on frontline trial results.

Q: What explains the one-year delay to the interim analysis for the frontline APCOR DLBCL2 trial for apcaritumab? / A: Management confirmed that the top-line interim analysis will be released in Q4 2026 as newly guided, and declined to provide additional detail on prior timeline projections ahead of data readout. The company noted this is the most important trial in the apcaritumab franchise, and all details will be shared once the data is finalized.

Q: How is pitocentamab differentiated from competing EGFR bispecifics in colorectal cancer, and is a combination with RAS-directed therapies a viable future strategy? / A: Management states that available Phase II data for pitocentamab shows higher response rates and a better safety profile (particularly lower skin-related toxicity) than competing amivantamab across multiple indications, supporting its best-in-class profile, which led the company to initiate Phase III trials despite competitors already having trials underway. The company is actively engaged in discussions to develop combinations with novel RAS-directed therapies in colorectal cancer, and more details will be shared in the near future.

Q: What is the status of patent protection for Epkinley, and are there any stocking issues that would affect full-year growth modeling? / A: There are currently no stocking issues for Epkinley, and growth in the community setting is driven by organic physician adoption of its differentiated dual-indication profile. Management declined to discuss detailed IP strategy on the call, but noted that current patent protection for Epkinley extends into the mid-2030s, with on-going IP strategy to extend protection further where possible.