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Passing of Genmab A/S' Annual General Meeting
GlobeNewswire News Room· 2025-03-12 14:23
Core Points - Genmab A/S held its Annual General Meeting on March 12, 2025, where the Annual Report for 2024 was approved and the Board of Directors received discharge [2][5] - The company's profit for the year was DKK 7,844 million, which will be carried forward to retained earnings [3][5] - Six members of the Board of Directors were re-elected for a one-year term, and Deloitte was re-elected as the company's auditor [3][5][6] Financial Decisions - The 2024 Compensation Report was approved [3][5] - Proposals from the Board of Directors included amendments to the Remuneration Policy, remuneration for 2025, reduction of share capital by DKK 2,076,853 through cancellation of treasury shares, authorization to acquire treasury shares, and issuance of warrants [5][6] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics to improve patient lives [4][7] - Established in 1999 and headquartered in Copenhagen, Denmark, Genmab aims to transform the lives of patients with cancer and other serious diseases by 2030 [4][7]
Genmab Announces Johnson & Johnson Decision Regarding HexaBody®-CD38
Newsfilter· 2025-03-10 14:13
Core Viewpoint - Johnson & Johnson (J&J) has opted not to exercise its option for a worldwide license to develop, manufacture, and commercialize HexaBody-CD38, leading Genmab to halt further clinical development of the drug despite promising initial clinical data [1][2][8] Group 1: Clinical Data and Development - Initial clinical data for HexaBody-CD38 showed robust efficacy, with an overall response rate (ORR) of 55% in the intravenous arm compared to 52% in the subcutaneous daratumumab arm [4] - The Phase 2 expansion study assessed the objective response rate as the primary endpoint, comparing HexaBody-CD38 with daratumumab in patients with relapsed or refractory multiple myeloma [3][9] - Treatment emergent adverse events (TEAEs) above 20% in the HexaBody-CD38 arm included neutropenia, infusion-related reactions, anemia, and thrombocytopenia, with no new safety findings in the daratumumab arm [5] Group 2: Company Strategy and Pipeline - Genmab remains focused on its existing pipeline, which includes EPKINLY® (epcoritamab) and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab, both in Phase 3 development [2] - The company emphasizes disciplined investments in its late-stage proprietary clinical pipeline to ensure future growth [2] - Genmab's 2025 financial guidance remains unaffected by the decision regarding HexaBody-CD38 [6] Group 3: Future Communications - Genmab will host a conference call to discuss the implications of this announcement, scheduled for today at 5:00 PM CET [7]
Genmab Announces Johnson & Johnson Decision Regarding HexaBody®-CD38
Globenewswire· 2025-03-10 14:13
Core Viewpoint - Johnson & Johnson (J&J) has opted not to exercise its option for a worldwide license to develop, manufacture, and commercialize HexaBody-CD38, leading Genmab to halt further clinical development of the drug despite promising initial clinical data [1][2][8]. Group 1: Clinical Data and Development - Initial clinical data for HexaBody-CD38 showed robust efficacy, with an overall response rate (ORR) of 55% in the intravenous arm compared to 52% in the subcutaneous daratumumab arm [4]. - The Phase 2 expansion study assessed the objective response rate as the primary endpoint, comparing HexaBody-CD38 with daratumumab in patients with relapsed or refractory multiple myeloma [3][9]. - Treatment emergent adverse events (TEAEs) above 20% in the HexaBody-CD38 arm included neutropenia, infusion-related reactions, anemia, and thrombocytopenia, with no new safety findings in the daratumumab arm [5]. Group 2: Future Focus and Pipeline - Genmab remains confident in its existing pipeline, which includes EPKINLY (epcoritamab) and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab, both in Phase 3 development [2]. - The company intends to maintain a disciplined investment strategy focused on its promising late-stage proprietary clinical pipeline to ensure future growth [2]. Group 3: Financial Guidance and Communication - The decision by J&J does not impact Genmab's financial guidance for 2025 [6]. - Genmab will host a conference call to discuss the event, providing an opportunity for stakeholders to gain further insights [7].
Transactions with shares and linked securities in Genmab A/S made by managerial employees and their closely associated persons
Globenewswire· 2025-02-28 21:04
Company Overview - Genmab A/S is an international biotechnology company focused on improving the lives of patients through innovative antibody therapeutics [3][4] - Established in 1999 and headquartered in Copenhagen, Denmark, Genmab has a global presence in North America, Europe, and Asia Pacific [4] Business Strategy and Vision - The company aims to transform the lives of individuals with cancer and other serious diseases by 2030 through its proprietary pipeline of advanced antibody medicines [3] - Genmab's research includes next-generation antibody technology platforms, bispecific T-cell engagers, antibody-drug conjugates, and immune checkpoint modulators [3] Managerial Transactions - The managerial employees and their closely associated persons have authorized Genmab to publish their trading activities in Genmab shares [2][1]
Grant of Restricted Stock Units to Management and Employees and Grant of Warrants to Employees in Genmab
GlobeNewswire News Room· 2025-02-28 21:00
Core Points - Genmab A/S announced the granting of 614,676 restricted stock units and 517,191 warrants to management and employees [1] - The fair value of each restricted stock unit is DKK 1,608.50, while the exercise price for each warrant is also DKK 1,608.50 [1][3] - The restricted stock units will vest after three years, and the warrants will vest three years after the grant date, expiring at the seventh anniversary [2][4] Restricted Stock Units - Each restricted stock unit provides a conditional right to receive one share of Genmab A/S of nominally DKK 1 [1] - Vesting of restricted stock units for executive management is subject to performance criteria [1] - The fair value of each restricted stock unit is based on the closing market price on the date of grant [1] Warrants - Each warrant entitles the owner to subscribe for one share of nominally DKK 1, subject to payment of the exercise price [3] - The fair value of each warrant, calculated using the Black-Scholes formula, is DKK 501.65 [3] - The new warrants are granted under the terms set out in the warrant program adopted by the Board of Directors [4] Company Overview - Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics [5] - The company has a proprietary pipeline that includes bispecific T-cell engagers and next-generation immune checkpoint modulators [5] - Genmab aims to transform the lives of people with cancer and other serious diseases with its antibody medicines by 2030 [5]
EPKINLY® (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare for Additional Indication as a Treatment for Relapsed or Refractory Follicular Lymphoma
Globenewswire· 2025-02-20 13:00
Core Viewpoint - Genmab A/S has received approval from the Japan Ministry of Health, Labour and Welfare for EPKINLY (epcoritamab) to treat patients with relapsed or refractory follicular lymphoma (FL) who have undergone two or more prior lines of therapy, marking it as the first and only T-cell engaging bispecific antibody administered subcutaneously approved in Japan for this indication [2][8][11]. Group 1: Product Approval and Indications - EPKINLY is now approved for both relapsed or refractory follicular lymphoma and relapsed or refractory large B-cell lymphomas in Japan after two or more prior lines of therapy [2][8]. - The approval is based on results from the global Phase 1/2 EPCORE NHL-1 and the Japanese Phase 1/2 EPCORE NHL-3 clinical trials, which demonstrated strong efficacy and safety profiles [4][8]. Group 2: Clinical Trial Results - In the EPCORE NHL-1 trial, among 128 evaluable patients with R/R FL, the overall response rate (ORR) was 82% and the complete response (CR) rate was 62.5% [5]. - The Japanese trial (EPCORE NHL-3) showed an ORR of 95.2% and a CR rate of 76.2% among 21 evaluable patients, with 88.9% achieving minimal residual disease (MRD) negativity [9]. Group 3: Safety and Adverse Events - In the EPCORE NHL-1 trial, 93% of patients experienced treatment-emergent adverse events (TEAEs), with the most common being cytokine release syndrome (CRS) at 66.4% [6]. - In the EPCORE NHL-3 trial, 90.5% of patients reported TEAEs, with CRS occurring in 90.5% and injection site reactions in 71.4% [10]. Group 4: Company Commitment and Future Development - Genmab is committed to making EPKINLY available to patients and is pursuing additional international regulatory approvals for the investigational R/R FL indication and R/R DLBCL indication [11][15]. - The company continues to evaluate epcoritamab in various clinical trials across different hematologic malignancies, including ongoing Phase 3 trials [16][17].
Genmab: Positive 2025 Outlook, Johnson & Johnson's Decision Coming Soon
Seeking Alpha· 2025-02-18 07:25
Core Insights - Genmab (GMAB) reported strong Q4 2024 results, with revenue guidance for 2025 slightly ahead of Street consensus and expense guidance below expectations [2] Financial Performance - Q4 2024 results were strong, contributing to a rebound in the stock price following the earnings report [2] Future Outlook - The 2025 revenue guidance provided by Genmab is slightly above market expectations, indicating positive growth prospects [2]
Genmab(GMAB) - 2024 Q4 - Earnings Call Transcript
2025-02-14 14:32
Financial Data and Key Metrics Changes - In 2024, the company achieved a total revenue growth of 31%, driven by the success of eight commercialized medicines, including EPKINLY and TIVDAK [8][10] - Operating profit grew by 26%, reflecting strong business performance despite significant investments [9][10] - Recurring revenues increased by 35%, representing 91% of total revenue, up from 88% in 2023 [41][43] Business Line Data and Key Metrics Changes - EPKINLY generated $281 million in sales for the year, with $78 million in Q4, primarily from the U.S. and Japan [30][34] - TIVDAK produced $131 million in sales for the year, including $38 million in Q4, driven by strong utilization rates [36] - The company has 12 products or candidates in 30 clinical trials, including seven Phase III trials [11] Market Data and Key Metrics Changes - EPKINLY is positioned as the first and only bi-specific approved for dual indications in the U.S. and Japan, with anticipated approval for additional indications [15][34] - TIVDAK is regarded as the global standard of care in advanced cervical cancer, with expected approvals in new markets [36][38] Company Strategy and Development Direction - The company is focused on accelerating late-stage programs and maximizing the success of commercialized medicines, with significant investments planned for 2025 [7][23] - Strategic investments are being made in high-potential programs like EPKINLY, Rina-S, and Acasunlimab, with a disciplined approach to capital allocation [61][62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong execution and disciplined investments that have solidified the company's foundation for sustainable success [7][10] - The company anticipates continued growth in recurring revenues and plans to maintain a focus on high-impact late-stage programs [50][56] Other Important Information - The company plans to repurchase approximately 1.9 million shares, equivalent to around $370 million, reflecting confidence in future growth [63] - The effective tax rate decreased to 14.4% from 22.8% due to the recognition of deferred tax assets [47] Q&A Session Summary Question: Confidence in endometrial cancer opportunity for Rina-S - Management highlighted robust efficacy data expected to be presented publicly, driving excitement for the Phase III commitment [71][72] Question: Competitive landscape for EPKINLY in DLBCL - Management noted recent NCCN inclusion of GemOx with EPKINLY, enhancing its competitive positioning [78] Question: Market dynamics for EPKINLY in Q4 - A one-time accounting adjustment in Europe impacted Q4 numbers, but overall growth trajectory remains strong [87] Question: Peak sales estimate for Acasunlimab - Management explained that the estimate considers the competitive landscape and treatment intervals [84][91] Question: Clinical development plans for Rina-S in other solid tumors - The company is enrolling patients in non-small cell lung cancer and triple-negative breast cancer cohorts, with plans for further updates [140]
Genmab(GMAB) - 2024 Q4 - Earnings Call Presentation
2025-02-14 11:41
Year End Results © Genmab 2025 Period Ended December 31, 2024 Forward looking statement This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (includi ...
Genmab(GMAB) - 2024 Q4 - Annual Report
2025-02-12 18:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ◻ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ⌧ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ◻ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 1 ...