Total Revenue Growth: 19% increase in the first half of 2025. Operating Profit Growth: 56% increase in the first half of 2025. Cash Position: Approximately $3 billion at the end of the first half of 2025. EPKINLY Sales: $211 million in global sales, a 74% year-over-year increase. TIVDAK Sales: $78 million in global sales, a 30% increase compared to the previous year. Recurring Revenue Growth: 27% increase, driven by royalties from DARZALEX and Kesimpta. DARZALEX Net Sales: Nearly 22% growth, totaling $6.8 billion for the first half of the year. Operating Expenses: Slightly less than $1 billion, up 6% over the first half of last year. Net Profit: $531 million for the first half of 2025. 2025 Revenue Guidance: Projected range of $3.5 billion to $3.7 billion, with a 15% growth at the midpoint. Operating Profit Guidance: Projected range of $1.1 billion to $1.4 billion, with a 26% growth at the midpoint.

Warning! GuruFocus has detected 4 Warning Signs with GMAB.

Release Date: August 07, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

Genmab AS (NASDAQ:GMAB) reported a 19% increase in total revenue for the first half of 2025, driven by increased recurring revenue. Operating profit grew by 56%, despite strategic investments in high-impact programs. The company completed a share buyback, demonstrating confidence in its future and commitment to shareholder value. Genmab AS (NASDAQ:GMAB) ended the first half with approximately $3 billion in cash, providing financial flexibility for growth and expansion. The EPCORE FL-1 study met its dual endpoints of progression-free survival and overall response rate, supporting global regulatory submissions.

Negative Points

The company faces potential risks from delayed or unsuccessful development projects, as highlighted in their forward-looking statements. There is ongoing uncertainty regarding regulatory approvals, particularly with the FDA's current chaotic state. The HexaBody-OX40 program was discontinued due to lack of differentiation, raising questions about the HexaBody platform. Genmab AS (NASDAQ:GMAB) is facing competitive pressure in the bispecific antibody market, particularly from other CD20 bispecifics. The company must navigate potential geopolitical impacts on its business, although no significant impact is anticipated for 2025.

Q & A Highlights

Q: What is your latest thinking on the positioning of EPCORE versus other C20 bispecifics in the competitive landscape, both in terms of clinical development and your commercial experience? A: Jan van de Winkel, CEO, and Tahamtan Ahmadi, CMO, emphasized Genmab's strong position with EPCORE, highlighting its broad and aggressive development plan. They noted that EPCORE has a head start in second-line follicular lymphoma and is progressing well in frontline studies. Brad Bailey, CCO, added that EPCORE's dual indication approval in over 60 countries is a differentiator, and they are seeing accelerating uptake in the community setting.

Story Continues

Q: How confident are you in filing RAINFOL-01 Part C for accelerated approval, and is there any risk of pushback from the FDA on EPCORE FL-1 to wait until OS is more mature? A: Judith Klimovsky, CDO, expressed confidence in the RAINFOL-01 Part C filing, stating that the accelerated approval is based on strong ORR and duration of response data. Regarding EPCORE FL-1, she mentioned active and positive engagement with the FDA, with the sBLA already accepted and a PDUFA date set for November, indicating confidence in the approval process.

Q: Could you outline your initial launch strategy for EPKINLY if approved in November, and how should we think about revenue contribution in '25 and '26? A: Brad Bailey, CCO, stated that the focus will be on expanding into earlier lines of therapy, particularly in the community setting where they have seen accelerating uptake. He emphasized the importance of second-line follicular lymphoma as a meaningful opportunity for both patients and the brand.

Q: What is the rationale for discontinuing HexaBody-OX40 in solid tumors, and how confident are you in the HexaBody platform? A: Jan van de Winkel, CEO, and Tahamtan Ahmadi, CMO, explained that the decision was based on prioritizing late-stage programs and focusing on assets with the most promising development paths. They remain confident in the HexaBody platform, with plans to bring a new asset into the clinic by the end of the year.

Q: How are you thinking about EPKINLY's opportunity and differentiation versus [lysumio] in follicular lymphoma? A: Tahamtan Ahmadi, CMO, highlighted that EPKINLY has a significant head start with positive Phase 3 results in second-line follicular lymphoma. He noted EPKINLY's better efficacy, higher CR rates, and subcutaneous administration as key differentiators, along with a strong safety profile.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.

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