Genmab A/S Reports Robust Revenue from Darzalex While Advancing Oncology Pipeline

Commercial Performance of Darzalex

Genmab A/S, a Danish biotechnology company listed on the OMX Nordic Exchange, disclosed that the global partnership with Johnson & Johnson generated nearly USD 14.4 billion in net sales for its flagship monoclonal‑antibody product, Darzalex, in 2025. This figure confirms Darzalex’s entrenched position as a leading therapeutic for multiple myeloma, reflecting sustained prescription volume across the United States and Europe.

The company indicated that further financial details will be released during the forthcoming quarterly conference, and analysts have projected a modest decline in earnings per share (EPS) relative to the previous fiscal year. The slight EPS dip is attributed primarily to higher operating expenses associated with ongoing regulatory and manufacturing capacity expansions, rather than a deterioration in product performance.

Phase‑III Clinical Update on Epcoritamab

In the therapeutic arena, Genmab’s bispecific antibody, epcoritamab, entered a phase‑III trial evaluating efficacy in patients with diffuse large B‑cell lymphoma (DLBCL). The study did not meet its primary endpoint of overall survival (OS) improvement, yet demonstrated a statistically significant benefit in progression‑free survival (PFS).

  • Efficacy Outcomes

  • Progression‑Free Survival: Median PFS extended by 4.3 months versus standard-of-care controls (HR = 0.72, 95 % CI 0.61–0.84).

  • Overall Survival: No clinically meaningful difference (HR = 0.95, 95 % CI 0.83–1.09).

  • Safety Profile

  • Cytokine Release Syndrome (CRS): Occurred in 12 % of participants; grade ≥ 3 CRS was 1 %.

  • Infusion‑related reactions: 8 % of patients reported mild to moderate reactions, managed successfully with pre‑medication.

  • Neutropenia and infections: Comparable incidence to the control arm, suggesting no new safety signals.

The mixed efficacy results have led to a muted market reaction among analysts, with most commentators focusing on the drug’s favorable PFS signal and manageable safety profile. Genmab has indicated that the company will pursue regulatory submission contingent on additional data to reinforce survival benefit, potentially through expanded indications or combination strategies.

Regulatory and Market Context

  • Darzalex

  • Maintains full regulatory clearance in the United States (FDA) and the European Union (EMA).

  • The partnership structure with Johnson & Johnson facilitates global distribution and access, contributing to the high net‑sales volume reported.

  • Epcoritamab

  • Pending submission to the FDA and EMA’s Committee for Advanced Therapies (CAT).

  • Given the phase‑III data, regulatory authorities may request supplementary post‑marketing studies to clarify the survival benefit.

Practical Implications for Patient Care

  • Multiple Myeloma: The substantial sales of Darzalex reflect continued confidence among clinicians, indicating that patients are benefitting from its efficacy and tolerability profile. Healthcare systems should continue to allocate budgetary resources for this agent while monitoring cost‑effectiveness as new competitors enter the market.

  • Diffuse Large B‑cell Lymphoma: Though overall survival was not improved, the PFS advantage positions epcoritamab as a potential second‑line therapy, particularly for patients who cannot tolerate intensive chemotherapy. The low incidence of severe CRS and manageable safety profile may encourage adoption in specialized oncology centers.

Analyst Perspective

Deutsche Bank’s latest commentary highlights potential upside in Genmab’s oncology portfolio, citing the durable revenue stream from Darzalex and the pipeline strength. Analyst consensus remains cautiously optimistic, noting that the company’s ability to translate clinical successes into commercial performance will be critical as it navigates regulatory milestones for epcoritamab.

Conclusion

Genmab A/S demonstrates a stable commercial footing through Darzalex while concurrently pursuing innovative therapies such as epcoritamab. The company’s forthcoming quarterly disclosures and upcoming regulatory submissions will be pivotal in determining future earnings trajectories and the overall impact on oncology therapeutic landscapes.