Core Insights - Genmab demonstrated significant progress in advancing its late-stage programs, with EPKINLY and Tivdak receiving approvals in additional territories, and Rina-S showing potential as a treatment for advanced ovarian cancer [2][7] Financial Performance - Genmab reported a revenue increase of 19% in Q1 2025, reaching $715 million compared to $603 million in Q1 2024, driven by higher royalties from DARZALEX and Kesimpta, as well as EPKINLY net product sales [7][8] - Royalty revenue rose to $589 million in Q1 2025, up 30% from $452 million in Q1 2024, attributed to increased net sales of DARZALEX and Kesimpta [8] - Net sales of DARZALEX reached $3,237 million in Q1 2025, a 20% increase from $2,692 million in Q1 2024 [8] - Total costs and operating expenses were $527 million in Q1 2025, an 8% increase from $487 million in Q1 2024, primarily due to product pipeline expansion and profit-sharing with AbbVie [8] - Operating profit for Q1 2025 was $188 million, compared to $116 million in Q1 2024 [8] - Net financial items resulted in income of $56 million in Q1 2025, down from $133 million in Q1 2024, mainly due to foreign exchange impacts from the change in functional currency [8] Outlook - Genmab is maintaining its 2025 financial guidance as published on February 12, 2025 [4] Other Matters - The functional currency of Genmab A/S has changed from DKK to USD effective January 1, 2025, with the presentation currency also changed to USD, affecting comparative figures for prior periods [5]

Core Viewpoint - Genmab A/S plans to submit a supplemental Biologics License Application (sBLA) for subcutaneous epcoritamab in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma in the first half of 2025 [1][3] Company Announcement - The sBLA submission is based on positive topline results from the Phase 3 EPCORE FL-1 trial, which showed that epcoritamab plus rituximab (R) met one of its dual primary endpoints of overall response rate (ORR) with a p-value of less than 0.0001 [2][7] - The safety profile of the combination therapy was consistent with known safety profiles of the individual components, and no new safety signals were observed [2][3] About Follicular Lymphoma (FL) - Follicular lymphoma is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all cases, with approximately 15,000 new cases diagnosed annually in the U.S. [4] - It is considered incurable with current standard therapies, and patients often experience shorter remission periods with each relapse [4] About the EPCORE FL-1 Trial - The EPCORE FL-1 trial is a Phase 3 open-label interventional study evaluating the safety and efficacy of epcoritamab plus rituximab and lenalidomide versus rituximab alone in patients with relapsed/refractory follicular lymphoma [5] About Epcoritamab - Epcoritamab is an IgG1-bispecific antibody developed using Genmab's DuoBody technology, designed to target CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells [6][7] - It is currently approved by the FDA as a monotherapy for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy [3][7] Collaboration and Future Plans - Genmab is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, and both companies are pursuing additional international regulatory approvals for the investigational indication [8][9] - Genmab and AbbVie are also evaluating epcoritamab in various hematologic malignancies across multiple ongoing Phase 3 trials [9]

Core Viewpoint - The article emphasizes the importance of value investing and highlights Genmab (GMAB) as a strong value stock based on various financial metrics and its current Zacks Rank [2][3][8] Financial Metrics - Genmab (GMAB) has a Zacks Rank of 2 (Buy) and a Value grade of A, indicating strong potential for value investors [3] - GMAB's PEG ratio is 2.09, which is lower than the industry average of 2.79, suggesting it may be undervalued relative to its expected earnings growth [4] - The P/B ratio for GMAB is 2.40, compared to the industry's average of 2.98, indicating an attractive valuation [5] - GMAB's P/S ratio stands at 4.14, which is lower than the industry average of 4.97, further supporting the notion of undervaluation [6] - The P/CF ratio for GMAB is 10.40, significantly lower than the industry's average of 12.87, suggesting a favorable cash flow outlook [7] Investment Outlook - The combination of GMAB's strong earnings outlook and favorable valuation metrics positions it as a compelling investment opportunity for value investors [8]

Editor's note: Seeking Alpha is proud to welcome Solomon Oshabaheebwa as a new contributing analyst. You can become one too! Share your best investment idea by submitting your article for review to our editors. Get published, earn money, and unlock exclusive SA Premium access.I am an independent investor and analyst with a background in Biomedical Engineering. Currently pursuing a PhD in the field, I leverage my research skills and biotech expertise to critically assess publicly traded companies, focusing o ...

Company Announcement - Genmab A/S reported worldwide net trade sales of DARZALEX (daratumumab) totaling USD 3,237 million in Q1 2025, with USD 1,829 million from the U.S. and USD 1,409 million from the rest of the world [1][5] - Genmab receives royalties on the worldwide net sales of DARZALEX, which includes both intravenous and subcutaneous products, under an exclusive license agreement with Johnson & Johnson [1][5] About Genmab - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics to improve patient lives, with a vision to transform cancer treatment by 2030 [2] - The company has a proprietary pipeline that includes bispecific T-cell engagers, antibody-drug conjugates, and next-generation immune checkpoint modulators [2] Company Background - Established in 1999, Genmab is headquartered in Copenhagen, Denmark, and has a presence in North America, Europe, and Asia Pacific [3]

Company Announcement - Genmab A/S has decided to reduce its share capital by DKK 2,076,853 through the cancellation of 2,076,853 shares with a nominal value of DKK 1 each [1] - The share capital reduction has been registered with the Danish Business Authority and is expected to be updated in Nasdaq's system by April 14, 2025 [1] - After the reduction, Genmab's total nominal share capital will be DKK 64,120,391, consisting of 64,120,391 shares, each with a nominal value of DKK 1 [1] About Genmab - Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics [2] - The company has developed next-generation antibody technology platforms and has a proprietary pipeline that includes bispecific T-cell engagers and antibody-drug conjugates [2] - Genmab aims to transform the lives of people with cancer and other serious diseases with its KYSO antibody medicines by 2030 [2] Company Background - Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with a presence in North America, Europe, and Asia Pacific [3]

Company Announcement COPENHAGEN, Denmark; April 7, 2025 – Genmab A/S (Nasdaq: GMAB). On March 25, 2025, Genmab announced the initiation of a share buy-back program to repurchase up to 2.2 million shares to reduce capital and to honor our commitments under the Restricted Stock Unit program. The share buy-back program is expected to be completed no later than July 10, 2025. The following transactions were executed under the program from March 31 to April 4, 2025: Trading PlatformNo. of sharesAverage price (D ...

Media Release COPENHAGEN, Denmark; March 31, 2025 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for TIVDAK (tisotumab vedotin), an antibody-drug conjugate (ADC), as monotherapy treatment for adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is the first and only ADC to be granted European Union (EU) marketing authorization for people living with recurrent or metastatic ce ...

The Japanese Ministry of Health, Labour and Welfare on Thursday approved Genmab A/S’ GMAB Tivdak (tisotumab vedotin) for advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy.Tivdak is the first and only antibody-drug conjugate (ADC) to be approved for cervical cancer in Japan.The approval is based on data from the Phase 3 innovaTV 301 clinical trial that evaluated the efficacy and safety of TIVDAK compared to chemotherapy in patients with advanced or recurrent cervical c ...

Media ReleaseCOPENHAGEN, Denmark; March 27, 2025 TIVDAK® is the first and only antibody-drug conjugate (ADC) approved for patients with advanced or recurrent cervical cancer in JapanApproval is based on results from the global Phase 3 innovaTV 301 trial, in which TIVDAK demonstrated superior overall survival compared to chemotherapyRising cervical cancer incidence and mortality rates in Japan signify need for new treatment options Genmab A/S (Nasdaq: GMAB) today announced that the Japan Ministry of Health, ...