Core Insights - Genmab A/S will present new research from its late-stage portfolio at the 2025 ASCO Annual Meeting from May 30 to June 3 in Chicago, Illinois [1] - The presentations will include results from a Phase 1/2 trial of rinatabart sesutecan (Rina-S) for recurrent/advanced endometrial cancer and long-term follow-up data from the EPCORE NHL-1 study of epcoritamab in relapsed/refractory diffuse large B-cell lymphoma [2][8] Company Commitment - Genmab emphasizes its commitment to advancing antibody science for patients needing alternative treatment options, particularly for endometrial cancers with rising mortality rates [3] - The company is encouraged by Rina-S as a potential treatment option for endometrial cancer and continues to evaluate epcoritamab as a core therapy across B-cell malignancies in collaboration with AbbVie [3][15] Event Details - Genmab will host a virtual review of the Rina-S data presented at ASCO on June 2 at 4:00 PM CDT, with details available on their investor relations website [4] Abstracts and Presentations - Abstracts accepted for presentation at ASCO include key studies on Rina-S and epcoritamab, with specific presentation times outlined [5][7]

Company Overview - Genmab A/S is an international biotechnology company focused on improving the lives of patients through innovative antibody therapeutics [2][3] - Established in 1999 and headquartered in Copenhagen, Denmark, Genmab has a global presence across North America, Europe, and Asia Pacific [3] Product Pipeline and Vision - Genmab has developed a proprietary pipeline that includes bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators, and effector function-enhanced antibodies [2] - The company's vision by 2030 is to transform the lives of people with cancer and other serious diseases through groundbreaking antibody medicines, referred to as "knock-your-socks-off" (KYSO) therapies [2] Upcoming Events - Judith Klimovsky, Chief Development Officer of Genmab, will participate in a fireside chat at the 2025 Jefferies Global Health Care Conference on June 5, 2025, at 9:20 EDT [1]

Core Insights - Genmab A/S is a biotech innovator focusing on antibody engineering and has a strategy that includes direct commercialization of its products Tivdak and Epcoritamab, as well as monetizing through partnerships and licensing drugs like Darzalex and Kesimpta [1] Group 1 - The company retains its value through innovative antibody engineering [1] - Genmab's strategy involves both direct product sales and partnerships for drug monetization [1]

Core Insights - Genmab is presenting 14 abstracts on epcoritamab at the 30th European Hematology Association Congress, showcasing its development across various patient populations and treatment settings [1][4] - Epcoritamab is a T-cell engaging bispecific antibody designed for treating diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) [6][7] Development Program - The abstracts include data from Phase 1/2 trials evaluating epcoritamab in combination with other therapies for relapsed/refractory DLBCL and previously untreated DLBCL [2][4] - Key trials include EPCORE NHL-2 and NHL-5, focusing on combinations with rituximab and polatuzumab vedotin [2][5] Presentation Details - Oral presentations will occur on June 15, 2025, featuring significant findings from the EPCORE NHL-2 and NHL-5 trials [5] - Additional results from NHL-1 and NHL-3 trials will be presented as posters, highlighting three years of follow-up data [2][5] Regulatory Status - Epcoritamab has received regulatory approval in specific lymphoma indications in the U.S., Japan, and the EU, and is co-developed with AbbVie [7][10] - The companies are pursuing further international regulatory approvals for additional indications [7] Future Directions - Genmab and AbbVie are conducting five ongoing Phase 3 trials to evaluate epcoritamab's efficacy as a monotherapy and in combination therapies across various hematologic malignancies [8][9] - The companies aim to establish epcoritamab as a core therapy for B-cell malignancies [4][8]

Financial Performance - Genmab's revenue for Q1 2025 increased by 19% to $715 million, up from $603 million in Q1 2024, driven by higher royalties from DARZALEX and Kesimpta[6] - Royalty revenue rose by 30% to $589 million in Q1 2025, compared to $452 million in Q1 2024, primarily due to increased net sales of DARZALEX and Kesimpta[6] - Operating profit for Q1 2025 was $188 million, an increase from $116 million in Q1 2024[10] - Net profit for Q1 2025 was $195 million, slightly up from $192 million in Q1 2024[10] - Genmab maintains its 2025 revenue guidance of $3.34 billion to $3.66 billion, with a projected midpoint of $3.5 billion[11] - Total costs and operating expenses for Q1 2025 were $527 million, an increase of 8% from $487 million in Q1 2024[10] - Milestone revenue decreased to $12 million in Q1 2025 from $50 million in Q1 2024, a decline of 76% due to a significant milestone achieved in the prior year[83] - Collaboration revenue increased to $16 million in Q1 2025 from $14 million in Q1 2024, a 14% increase driven by higher net sales of Tivdak[85] Product Sales and Royalties - Net sales of DARZALEX by J&J were $3,237 million in the first three months of 2025[58] - Net sales of DARZALEX were $3,237 million in Q1 2025, a 20% increase from $2,692 million in Q1 2024, with royalty revenue of $450 million[76] - Net sales of Kesimpta were $899 million in Q1 2025, a 41% increase from $637 million in Q1 2024, generating $90 million in royalty revenue[79] - Global net sales of EPKINLY/TEPKINLY were $90 million in Q1 2025, a 73% increase from $52 million in Q1 2024, driven by strong growth in 3L+ DLBCL and expansion to 3L+ FL[86] Research and Development - Genmab's product pipeline includes over 10 antibody products in clinical development, with ongoing collaborations for EPKINLY and Tivdak[20] - Epcoritamab (approved as EPKINLY and TEPKINLY) has received regulatory approvals in multiple territories including the U.S. and Europe for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy[24] - Genmab has a broad clinical development program for Epcoritamab, including five ongoing Phase 3 trials and additional trials in planning[26] - Acasunlimab (GEN1046) is designed to induce an antitumor immune response and is currently recruiting for a Phase 3 trial in metastatic NSCLC[30] - Rinatabart Sesutecan (Rina-S) has shown a confirmed objective response rate of 55.6% in heavily pre-treated ovarian cancer patients during a Phase 2 trial[32] - GEN1059, a bispecific antibody targeting EpCAM and 4-1BB, is in a Phase 1/2 clinical trial for solid tumors[43] - GEN1160, a CD70-targeted ADC, is currently recruiting for a Phase 1/2 clinical study in advanced renal cell carcinoma and nasopharyngeal carcinoma[40] - GEN1286, an ADC targeting EGFR and cMet, is in a Phase 1/2 clinical study for advanced solid tumors[44] Financial Position - Genmab's cash and cash equivalents at the end of Q1 2025 were $1.619 billion, compared to $2.127 billion at the end of Q1 2024[10] - Total assets as of March 31, 2025, were $6,586 million, an increase from $6,414 million on December 31, 2024[108] - Shareholders' equity increased by $159 million, or 3%, to $5,296 million as of March 31, 2025, compared to $5,137 million on December 31, 2024[111] - Cash provided by operating activities increased by $68 million to $287 million in the first three months of 2025, driven by higher operating profit[103] - Total financial income decreased to $101 million in the first three months of 2025 from $168 million in the same period of 2024, primarily due to lower gains on marketable securities[95] - The company reported a basic net profit per share of $3.06 for the first three months of 2025, compared to $2.96 in the same period of 2024[119] Shareholder Actions - During the first three months of 2025, Genmab acquired 316,630 of its own shares, representing approximately 0.5% of share capital, at a total cost of $63 million[164] - The company initiated a share buy-back program to reduce capital and fulfill commitments under the RSU program, authorized to acquire up to 10% of share capital until March 11, 2030[163] - For the first three months of 2025, Genmab granted 633,505 RSUs with a weighted average fair value of DKK 1,602.57, compared to 436,774 RSUs with a fair value of DKK 2,015.91 in the same period of 2024[159] Legal and Regulatory Matters - Genmab is facing legal challenges, including a patent infringement complaint from Chugai and a trade secret complaint from AbbVie, but has not recorded any provisions related to these matters[173][175] Strategic Direction - The company aims to transform the lives of patients with innovative antibody therapeutics by 2030, focusing on next-generation antibody technology platforms[179] - Genmab has entered multiple strategic collaborations to support the expansion of its innovative pipeline[50]

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]