Genmab’s Q1 2024 Results Signal Strong Momentum in Oncology Innovation

Genmab A/S (NASDAQ: GMAB), a leading biotechnology company focused on oncology therapies, delivered robust financial results for the first quarter of 2024, underscoring its transition into a fully integrated biopharma leader. The quarter saw revenue surge by 46% year-over-year to DKK 4.14 billion, driven by strong performance in its royalty streams and commercialized products, alongside strategic moves to bolster its pipeline.

Financial Performance: A Diverse Revenue Engine

Genmab’s revenue growth was fueled by:
1. Royalties: A 29% increase to DKK 3.1 billion, primarily from Janssen’s DARZALEX® (daratumumab), which reported USD 2.69 billion in net sales, up 19% year-over-year.
2. Commercialized Products:
- EPKINLY® (epcoritamab): Generated $54 million in net sales, with 90% of revenue from the U.S. and Japan.
- TIVDAK® (tisotumab vedotin): Achieved $27 million in sales, marking its 10th consecutive quarter of growth.
3. Milestone Payments: A one-time payment from AbbVie further bolstered results.

Operating profit nearly doubled to DKK 801 million (+90% YoY), while net financial income surged to DKK 915 million, benefiting from a strengthening U.S. dollar. Genmab reaffirmed its 2024 revenue guidance of DKK 18.7–20.5 billion, with EPKINLY and TIVDAK expected to contribute nearly 40% of total growth.

Regulatory and Clinical Milestones: A Pipeline on Track

The quarter was marked by significant progress in key programs:
- EPKINLY®: The FDA granted Priority Review for an expanded indication in relapsed/refractory follicular lymphoma (PDUFA date: June 28, 2024). The drug also received a NCCN 2A recommendation, positioning it as a preferred treatment in this setting.
- TIVDAK®: The FDA converted its accelerated approval to full approval for recurrent/metastatic cervical cancer, validated by a 30% improvement in overall survival in the Phase 3 RAINBOW trial. A Japan filing for cervical cancer was also submitted in April.
- Phase 3 Initiatives: Genmab launched a trial evaluating EPKINLY in combination therapy for untreated follicular lymphoma and advanced GEN1046 (a PD-L1/4-1BB bispecific) toward a Phase 3 trial in lung cancer.

Strategic Acquisitions and Pipeline Expansion

Genmab’s proposed USD 1.8 billion acquisition of ProfoundBio highlights its ambition to build an end-to-end pipeline. The deal adds Rina-S (PF-06939990), an ADC targeting ovarian cancer, which is expected to seek regulatory approval by 2027. With Rina-S, Genmab aims to capitalize on ADCs’ growing role in oncology, a market projected to reach $14.5 billion by 2030 (EvaluatePharma).

Risks and Considerations

• Regulatory Delays: While the FDA’s PDUFA date for EPKINLY in follicular lymphoma is imminent, any delay could impact timelines.
• Pipeline Toxicity: GEN1046’s liver toxicity, while manageable, remains a monitoring priority.
• Currency Risks: Genmab’s shift to USD as its functional currency (effective 2025) could amplify exchange rate volatility.

Conclusion: A Biotech on the Rise

Genmab’s Q1 results reflect a company strategically positioned to capitalize on its oncology portfolio’s potential. With EPKINLY and TIVDAK driving near-term growth, and ProfoundBio’s ADC platform unlocking long-term opportunities, the company is well-equipped to navigate an increasingly competitive market.

Key data points reinforce this outlook:
- Revenue Growth: 46% YoY increase to DKK 4.14 billion, with operating profit up 90%.
- Pipeline Value: Rina-S’s blockbuster potential (peak sales >$1 billion) and ongoing Phase 3 trials in high-unmet-need indications.
- Strategic Focus: A $1.8 billion acquisition underscores Genmab’s commitment to owning its pipeline, reducing reliance on partnerships.

Investors should monitor EPKINLY’s June PDUFA decision, TIVDAK’s Japan approval, and Rina-S’s development as key catalysts. While risks remain, Genmab’s financial resilience, diversified revenue streams, and innovation-driven strategy position it as a compelling play in the oncology space.

For further analysis, track Genmab’s stock performance and pipeline updates closely. The next 12 months could solidify its status as a leader in bispecific therapies and ADCs.