Executive Summary / Key Takeaways

• Genmab is undergoing a strategic transformation, shifting towards a wholly-owned commercial model, significantly expanding its late-stage pipeline with high-impact assets like EPKINLY, Rina-S, and acasunlimab, which are poised to drive substantial revenue growth by the end of the decade.
• The company demonstrates robust financial performance, with total revenue growing 19% and operating profit surging 56% in the first half of 2025, fueled by strong recurring revenues from royalty products and accelerating sales of its proprietary medicines.
• EPKINLY is establishing itself as a best-in-class bispecific in B-cell lymphomas, with recent positive Phase III data in follicular lymphoma and a November 2025 FDA action date for second-line FL, positioning it for peak sales exceeding $3 billion.
• Genmab's strategic acquisitions, notably ProfoundBio and the announced Merus acquisition, are rapidly bolstering its wholly-owned pipeline with differentiated assets like Rina-S, which is advancing into multiple Phase III trials with blockbuster potential.
• Despite significant R&D investments to accelerate its pipeline, Genmab maintains a strong financial foundation with approximately $3 billion in cash and provides an optimistic 2025 guidance, projecting 15% revenue growth and 26% operating profit growth at the midpoint.

The Antibody Innovator: Setting the Scene for Growth

Genmab A/S, incorporated in 1998 in Copenhagen, Denmark, has carved a formidable niche as a biotechnology company dedicated to developing innovative antibody-based products for cancer and other diseases. The company's foundational strength lies in its proprietary technology platforms, particularly DuoBody for bispecific antibodies and its recently expanded ADC (Antibody-Drug Conjugate) platforms. This specialized focus allows Genmab to develop highly targeted therapies, differentiating it from larger, more diversified pharmaceutical conglomerates. Its overarching strategy is to evolve into an integrated biotech innovation powerhouse, accelerating its late-stage pipeline and maximizing the success of its commercialized medicines to drive significant revenue growth.

The biotechnology industry is characterized by high R&D costs, stringent regulatory hurdles, and a constant need for specialized expertise, creating substantial barriers to entry. Genmab leverages these dynamics by focusing on differentiated antibody designs and strategic partnerships, which enhance its R&D capabilities and capital efficiency. While larger competitors like AbbVie (ABBV), Johnson & Johnson , Merck (MRK), Bristol-Myers Squibb (BMY), and Roche possess broader global footprints and diversified revenue streams, Genmab's agility and specialized expertise in antibody therapeutics allow it to compete effectively in specific, high-unmet-need segments. The company's collaborative model, exemplified by its partnerships with AbbVie and Johnson & Johnson, has historically enabled it to bring innovative medicines to market, such as DARZALEX and EPKINLY, while its recent strategic shifts underscore a move towards greater proprietary ownership and control over its pipeline.

Technological Edge: The Core of Genmab's Differentiated Approach

Genmab's competitive advantage is deeply rooted in its innovative antibody technology platforms, which enable the creation of highly specific and potent therapeutic candidates.

The DuoBody technology is central to Genmab's bispecific antibody development, exemplified by epcoritamab (EPKINLY/TEPKINLY). This technology allows for the creation of antibodies that can bind to two different targets simultaneously, enhancing therapeutic efficacy. For EPKINLY, this translates into a differentiated clinical profile that balances powerful efficacy, manageable safety, and seamless subcutaneous administration. Management highlights EPKINLY's superior efficacy, noting it has shown "better efficacy, higher CR rates, both in follicular lymphoma and then definitely also diffuse [large] B-cells" compared to competitors like mosunetuzumab. The subcutaneous administration offers a significant patient convenience advantage, which competitors are attempting to replicate but have not yet fully achieved. Furthermore, with subsequent optimization, EPKINLY's CRS (Cytokine Release Syndrome) rates are as low as those of its rivals. This technological differentiation is crucial for EPKINLY's market positioning as a potential core therapy across B-cell lymphomas.

The HexaBody platform is another proprietary technology designed to enhance antibody effector functions through hexamerization. While the HexaBody-OX40 (GEN1055) program in solid tumors was discontinued due to a lack of differentiation from other assets and a less promising development path, the company remains confident in the platform's potential. Management noted that the HexaBody-OX40 program "did show all the things that we were anticipating and hoping for both in terms of a much, much stronger signal in terms of the biology, but also in terms of overcoming the bell-shaped curve," indicating the platform's mechanistic validity. Genmab plans to bring a new HexaBody asset into the clinic by the end of 2025, underscoring its continued commitment to this innovative approach.

The recent acquisition of ProfoundBio has significantly expanded Genmab's capabilities in ADC (Antibody-Drug Conjugate) platforms. This acquisition brought Rinatabart Sesutecan (Rina-S) into the wholly-owned pipeline, a next-generation ADC. Rina-S is designed to broaden and deepen activity beyond first-generation folate receptor alpha (FRα) approaches. A key technological differentiator for Rina-S is its novel proprietary hydrophilic linker technology, which contributes to a "differentiated safety profile, avoiding interstitial lung disease and corneal toxicity seen with other ADC therapies". This is a critical advantage, as these toxicities have been limiting factors for other ADCs. The data for Rina-S also supports its efficacy "irrespective of the level of folate receptor alpha expression," which significantly expands its potential patient population across diverse tumor types, including those with low to medium FRα expression. This broad applicability is a direct benefit of the underlying ADC technology and its linker design.

Genmab's R&D initiatives are strategically aligned with these technological strengths. The company is exploring the potential of T-cell redirection, particularly in solid oncology, where it has been challenging to replicate the success seen in hematologic malignancies. Its collaboration with Revitope aims to complement internal discovery efforts and expand opportunities in this space, utilizing technologies that are complementary to its DuoBody platform. The ongoing development of GEN1042 (CD40x4-1BB) also highlights Genmab's focus on immune-activating bispecifics, with management expressing excitement about its potential for combination therapies with ADCs and other concepts. These technological advancements and R&D efforts are not merely scientific pursuits; they are integral to Genmab's strategy for building a sustainable competitive moat, driving higher efficacy, improving safety profiles, and ultimately enhancing financial performance through market leadership and expanded patient access.

Strategic Evolution and Pipeline Acceleration

Genmab is actively transforming its business model, strategically shifting towards a wholly-owned commercialization approach and aggressively expanding its late-stage pipeline. This evolution is designed to capture greater value from its innovative medicines and secure long-term growth.

A pivotal moment in this transformation was the acquisition of ProfoundBio in May 2024. This "historic event" brought Rinatabart Sesutecan (Rina-S) and next-generation ADC platforms into Genmab's wholly-owned portfolio. Rina-S is viewed as a potential best-in-class treatment for ovarian cancer and other FRα-expressing solid tumors, with an anticipated first approval in 2027 and peak sales exceeding $2 billion in ovarian and endometrial cancers. The rapid integration of ProfoundBio is evident in Genmab's plan to have three Phase III trials for Rina-S underway by the end of 2025, including one ongoing in platinum-resistant ovarian cancer and new trials in endometrial cancer and platinum-sensitive ovarian cancer.

Further solidifying its wholly-owned model, Genmab took full control of the acasunlimab (GEN1046) program in June 2024 after BioNTech (BNTX) opted out due to strategic portfolio prioritization. Genmab is "very, very pleased to have it now wholly owned" and intends to progress it aggressively, potentially seeking regional partners for territories like China in the future. Acasunlimab, an immune activator, is advancing into a Phase III trial in PD-L1 positive non-small cell lung cancer (NSCLC) by the end of 2024, with overall survival as the primary endpoint and docetaxel as the control arm. A Phase II study in advanced melanoma is also launching. Peak sales for acasunlimab are anticipated to be around $1 billion.

Most recently, on September 29, 2025, Genmab announced its intent to acquire Merus , a move aimed at further expanding its late-stage pipeline and accelerating its transition into a wholly-owned model. This demonstrates Genmab's proactive approach to inorganic growth that aligns with its strategic objectives.

This strategic prioritization has also necessitated tough decisions. Genmab terminated early-stage clinical programs (GEN1047, GEN3017, GEN1056) and decided against Phase III development for Tivdak in head and neck cancer, as these programs did not meet the company's high bar for differentiated therapeutic candidates. Similarly, the HexaBody-OX40 (GEN1055) program was discontinued in solid tumors due to a lack of differentiation and less promising development path. These actions underscore Genmab's disciplined approach to capital allocation, focusing resources on assets with the highest potential for long-term value creation.

Commercial Momentum and Market Penetration

Genmab's commercialized medicines and royalty-generating products are demonstrating strong momentum, underpinning the company's financial growth and validating its strategic investments.

In the first half of 2025, total revenue grew by 19%, primarily driven by a 27% increase in recurring revenue. This recurring revenue, which represented 97% of total revenue in H1 2025 (up from 90% in H1 2024), highlights the improving quality and stability of Genmab's revenue profile.

DARZALEX, developed in partnership with Johnson & Johnson , continues to be a significant revenue driver. In the first half of 2025, DARZALEX net sales grew by nearly 22% to $6.8 billion, translating to over $1 billion in royalty revenue for Genmab. This growth is attributed to continued market share gains and strong performance in the frontline multiple myeloma setting, where DARZALEX is considered foundational to survival. For the full year 2025, DARZALEX sales are anticipated to be in the range of $12.6 billion to $13.4 billion.

Genmab's proprietary commercialized medicines, EPKINLY and Tivdak, are rapidly increasing their contribution. Combined sales for these two products were up 60% year-over-year in the first half of 2025, contributing 31% to total revenue growth.

EPKINLY (epcoritamab) is establishing itself as a key player in B-cell lymphomas. Global sales reached $211 million in the first half of 2025, a 74% year-over-year increase, driven by strong performance in the U.S. and Japan. EPKINLY is uniquely positioned as the "first and only bispecific approved as an off-the-shelf dual indication option in DLBCL and FL" across over 60 countries, with nearly 50 approvals for both indications. The launch in follicular lymphoma (FL) has been particularly encouraging, building on the uptake seen in large B-cell lymphoma (LBCL). A significant competitive advantage is EPKINLY's FL label, which does not require hospitalization, facilitating broader adoption in community settings. Genmab is actively working to extend this benefit to the DLBCL label, leveraging data from optimization cohorts and outpatient studies. The company anticipates peak sales for EPKINLY exceeding $3 billion.

Tivdak (tisotumab vedotin) continues its strong performance, with global sales totaling $78 million in the first half of 2025, up 30% from the prior year. It is regarded by physicians as "the global standard of care and the clear answer in second-line plus recurrent or metastatic cervical cancer" due to its proven survival benefit. Genmab is expanding its commercial footprint for Tivdak, having transitioned to full commercialization responsibilities outside the U.S. and China from Pfizer (PFE), effective January 1, 2025. This strategic move enables Genmab to lead launches in new markets, with Japan's independent launch in May 2025 and Germany anticipated as the first European launch soon.

Financial Strength and Disciplined Capital Allocation

Genmab's financial foundation remains exceptionally strong, providing the necessary flexibility to execute its ambitious growth strategy. The company ended the first half of 2025 with approximately $3 billion in cash, reinforcing its ability to fund continued growth and expansion.

This robust liquidity supports a disciplined capital allocation strategy that prioritizes:

• Accelerating late-stage pipeline development: Investments are heavily skewed towards high-impact Phase III programs like EPKINLY, Rina-S, and acasunlimab. R&D investments in these late-stage programs are projected to increase from 45% of total R&D spending in 2024 to over 55% in 2025.
• Maximizing commercialized medicines: Strategic investments are made to support launches and market penetration for EPKINLY and Tivdak.
• Pursuing focused business development and M&A: The acquisitions of ProfoundBio and the announced Merus (MRUS) acquisition exemplify this commitment to inorganic growth, targeting differentiated, antibody-based medicines, ideally at Phase III or Phase III-ready stages.
• Returning capital to shareholders: Genmab completed a share buyback in June 2025 and announced plans to repurchase an additional 1.9 million shares (approximately $370 million) in 2025, underscoring confidence in its future and commitment to shareholder value.

Genmab's operational discipline is evident in its ability to grow operating profit significantly even while making substantial strategic investments. In the first half of 2025, operating profit grew by an impressive 56%, despite total operating expenses increasing by 6% (excluding the ProfoundBio acquisition impact). For the full year 2025, operating expenses are expected to be in the range of $2.1 billion to $2.2 billion, reflecting this disciplined approach. The effective tax rate, which was 14.4% in 2024 due to deferred tax asset recognition, is anticipated to normalize closer to the Danish statutory rate of 22% moving forward. The integration of ProfoundBio operations may cause some tax rate volatility, but this is expected to normalize within 12 to 18 months.

Outlook and Growth Catalysts

Genmab has improved its 2025 financial guidance, projecting robust growth driven by its accelerating pipeline and commercial momentum. The company now expects total revenue for 2025 to be in the range of $3.5 billion to $3.7 billion, representing a strong 15% growth at the midpoint, an increase from its previous 12% guidance. This upward revision is primarily driven by the strong performance of DARZALEX and positive EPKINLY sales momentum. Recurring revenues are anticipated to grow 22% in 2025, up from the previous 18% guidance, further solidifying the quality of Genmab's revenue streams. Operating profit for 2025 is projected to be between $1.1 billion and $1.4 billion, with the midpoint reflecting over $1.2 billion and a significant 26% year-over-year growth.

Several key pipeline catalysts are expected to drive future growth:

• EPKINLY: The sBLA for epcoritamab in second-line follicular lymphoma in combination with R-square was accepted for priority review by the FDA, with a target action date of November 30, 2025. Furthermore, the EPCORE FL-1 study met its dual primary endpoints of progression-free survival and overall response rate in a preplanned interim analysis, with these "unprecedented positive results" forming the basis for global regulatory submissions. Genmab anticipates three potentially significant pivotal readouts for EPKINLY by the end of 2026, including frontline and second-line DLBCL, which could lead to substantial market expansion and regulatory filings.
• Rina-S: Genmab plans to have three Phase III trials underway by the end of 2025, including an ongoing trial in platinum-resistant ovarian cancer and new trials in endometrial cancer and platinum-sensitive ovarian cancer. A Phase II trial in non-small cell lung cancer is also slated to start dosing patients in Q4 2025. The first potential approval for Rina-S in ovarian cancer is anticipated in 2027.
• Acasunlimab: A Phase III trial in PD-L1 positive non-small cell lung cancer is expected to commence before the end of 2024, with overall survival as the primary endpoint. A Phase II study in advanced melanoma is also launching.
• HexaBody-CD38: A decision from Johnson & Johnson regarding their opt-in for HexaBody-CD38 is anticipated no later than Q1 2025, with top-line clinical data to be released upon that decision.

These initiatives, coupled with Genmab's increasing R&D investment in late-stage programs, underscore the company's commitment to translating its innovative science into commercial success.

Risks and Competitive Landscape

While Genmab's outlook is strong, investors should consider several pertinent risks. Regulatory hurdles, as highlighted by an analyst's comment on "chaos at the FDA," could impact approval timelines for pipeline assets. However, Genmab's development team expresses confidence in its regulatory pathways, citing breakthrough therapy designations and accepted sBLAs. The effective tax rate may experience volatility during the integration of ProfoundBio (PFBS) operations, though normalization is expected within 12 to 18 months.

The competitive landscape in oncology remains intense. In B-cell lymphomas, EPKINLY faces competition from other CD20 bispecifics like mosunetuzumab. Genmab believes EPKINLY holds a "significant head start" with positive Phase III data in second-line FL, while competitors have not yet reported similar results. EPKINLY's superior efficacy, higher complete response rates, and subcutaneous administration are key differentiators. In cervical cancer, Tivdak's position as "the only ADC with a proven survival benefit" and "clear standard of care" provides a strong competitive moat. For Rina-S, the presence of other folate receptor alpha-targeting therapies like mirvetuximab is a factor, but Genmab's strategy to not preselect for FRα expression in its Phase III trials, based on observed efficacy across the biomarker spectrum, aims to address a broader patient population. In NSCLC, acasunlimab enters a competitive space, but its differentiated profile and focus on PD-L1 positive, CPI-pretreated patients offer a unique opportunity.

Genmab's smaller scale compared to pharmaceutical giants like Johnson & Johnson (JNJ) or Roche (RHHBY) could lead to higher operational costs and potentially limit its global market expansion capabilities. However, its strategic partnerships and focused R&D allow it to maintain innovation speed and target niche markets effectively. The company's disciplined portfolio prioritization, including the discontinuation of less differentiated programs, reflects a proactive approach to managing pipeline risks and optimizing resource allocation.

Conclusion

Genmab is at a pivotal juncture, executing a strategic transformation that promises to redefine its position in the biotechnology landscape. By accelerating its late-stage pipeline, particularly with high-impact wholly-owned assets like EPKINLY, Rina-S, and acasunlimab, the company is laying a robust foundation for sustainable, long-term revenue growth. Its proprietary antibody technologies, including DuoBody and advanced ADC platforms, provide a critical competitive edge, delivering differentiated efficacy and safety profiles that address significant unmet medical needs.

The strong financial performance, characterized by surging operating profits and a healthy cash position, underscores Genmab's operational efficiency and disciplined capital allocation. With an optimistic 2025 guidance and a series of imminent pipeline catalysts, Genmab is poised to capitalize on its innovative science and expand its global commercial footprint. While competitive pressures and regulatory complexities persist, Genmab's unwavering focus on differentiated antibody medicines and its strategic evolution into an integrated biotech powerhouse position it as a compelling investment opportunity for those seeking exposure to a dynamic and innovative leader in oncology.