Genmab’s Q1 Surge: A Catalyst-Driven Ascend in Oncology Leadership

Genmab A/S (GMD) delivered a robust Q1 2025 performance, marking its evolution into a commercial-stage biotech powerhouse. With DARZALEX’s record sales, transformative pipeline advancements, and strategic financial positioning, the company is poised to capitalize on oncology’s growing therapeutic demands.

DARZALEX: The Engine of Growth

Genmab’s royalty-driven model remains its financial cornerstone, with DARZALEX (daratumumab) leading the charge. Q1 sales surged to $3.237 billion, a 20% year-over-year increase, fueled by demand for both its IV and subcutaneous formulations. U.S. sales accounted for 50% of global revenue, while international markets—including Europe and Japan—showed strong momentum. With Johnson & Johnson (J&J) maintaining aggressive commercialization, Genmab’s royalty intake rose 30% to $589 million, underpinning its $715 million total revenue (up 19% YoY).

Pipeline Momentum: From Trials to Markets

Genmab’s pipeline is now its second growth lever, with four late-stage programs advancing rapidly:

EPKINLY® (epcoritamab): A Dual-Target Breakthrough

EPKINLY’s $90 million in Q1 sales (up 73% YoY) reflect its rising adoption as a bispecific CD3/CD20 antibody for B-cell lymphomas. Recent wins include:
- Japan’s approval for relapsed/refractory follicular lymphoma (FL), its second indication in the market.
- NCCN’s Category 2a recommendation for first-line relapsed/refractory DLBCL, positioning it as a preferred therapy.
- Phase 3 data for first-line DLBCL and FL are expected in 2025, which could expand its addressable market to $2.1 billion by 2030 (EvaluatePharma).

Tivdak® (tisotumab vedotin): First-in-Class Cervical Cancer ADC

Approved in the EU and Japan for recurrent/metastatic cervical cancer, Tivdak’s sales rose 22% to $33 million, driven by its Category 1 NCCN recommendation as a preferred second-line therapy. With cervical cancer’s global incidence rising and limited treatment options, Tivdak’s $4.5 billion potential peak sales (analyst estimates) make it a critical diversification asset.

Rina-S® (rinatabart sesutecan): Aiming for Best-in-Class Ovarian Cancer Therapy

Data from the 2025 Society of Gynecologic Oncology Annual Meeting highlighted Rina-S’s 44% confirmed ORR in platinum-resistant ovarian cancer (PROC), with minimal safety concerns. Phase 3 trials in PROC and endometrial cancer are progressing, and if approved, Rina-S could capture a $1.3 billion market (GlobalData). However, its development contributed to a $40 million increase in operating expenses (to $527 million), underscoring Genmab’s commitment to high-risk, high-reward programs.

Financials and Strategy: A Roadmap for Growth

Genmab’s Q1 results reaffirm its 2025 guidance:
- Revenue: $3.34–3.66 billion (+12% midpoint YoY).
- Operating profit: $1.13 billion (+16% YoY).
- Cash balance: $3.2 billion, enabling $2.14 billion in R&D spending (+7% YoY) and potential shareholder returns.

Risks and Considerations

• Patent cliffs: DARZALEX’s U.S. patent expires in 2028, risking generic competition.
• Regulatory delays: Rina-S’s Phase 3 data (expected late 2025) and EPKINLY’s first-line approvals are critical milestones.
• Market saturation: DARZALEX’s growth may slow as it matures in multiple myeloma indications.

Conclusion: A Biotech on the Brink of Transformation

Genmab’s Q1 results signal a strategic inflection point. With DARZALEX’s sustained dominance, EPKINLY and Tivdak’s commercial ascension, and Rina-S’s potential to redefine ovarian cancer treatment, the company is transitioning from a royalty-dependent firm to a fully integrated oncology leader.

The $3.2 billion cash buffer and 2025 guidance (implying a $3.5 billion revenue midpoint) suggest resilience against near-term risks. Analyst consensus values Genmab at $14.30 per share (DAN) in 2025, with upside potential if Rina-S and EPKINLY’s Phase 3 trials succeed. Investors should monitor Q3 2025 data reads for Rina-S and EPKINLY’s first-line DLBCL trial, which could re-rate the stock to a $17–20 target range.

In a crowded oncology space, Genmab’s combination of validated late-stage assets, diverse revenue streams, and financial flexibility positions it as a compelling play for both growth and stability—a rare find in today’s biotech landscape.