Genmab(GMAB)
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Genmab to Hold 2024 R&D Update and ASH Data Review Meeting
GlobeNewswire News Room· 2024-12-11 13:20
Media Release Event to be held virtually via live webcast and archived on www.genmab.com Copenhagen, Denmark; December 11, 2024 – Genmab A/S (Nasdaq: GMAB) will hold its 2024 R&D Update and ASH Data Review Meeting today, December 11, 2024 at 11:00 AM Eastern Time (5:00 PM CET / 4:00 PM GMT). The event will take place virtually in English and can be attended via live webcast. To register for the webcast, click https://genmab-post-ash-2024.open-exchange.net/. An archive of the webcast will be available on Gen ...
Capital Increase in Genmab as a Result of Employee Warrant Exercise
GlobeNewswire News Room· 2024-12-03 21:35
Company Announcement COPENHAGEN, Denmark; December 3, 2024 – Genmab A/S (Nasdaq: GMAB) will increase its share capital by 10,355 shares as a consequence of the exercise of employee warrants. The increase is effected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following price per share of nominally DKK 1: 554 shares at DKK 962.00,3,436 shares at DKK 1,025.00,4,942 shares at DKK 1,032.00,305 shares at DKK 1,050.00, and1,118 sha ...
Transactions With Shares and Linked Securities in Genmab A/S Made by Managerial Employees and Their Closely Associated Persons
GlobeNewswire News Room· 2024-12-03 12:07
Company Announcement COPENHAGEN, Denmark; December 3, 2024 – Genmab A/S (Nasdaq: GMAB) – In accordance with Article 19 of Regulation No. 596/2014 on Market Abuse and Implementing Regulation 2016/523, this document discloses the data of the transactions made in Genmab A/S (Nasdaq: GMAB) made by managerial employees and their closely associated persons. The company’s managerial employees and their closely associated persons have given Genmab A/S power of attorney on their behalf to publish trading in Genmab s ...
Grant of Restricted Stock Units and Warrants to Employees in Genmab
GlobeNewswire News Room· 2024-11-21 19:48
Company Announcement COPENHAGEN, Denmark; November 21, 2024 – Genmab A/S (Nasdaq: GMAB) announced today that the Board decided to grant 10,273 restricted stock units and 10,853 warrants to employees of the Company and the Company's subsidiaries. Each restricted stock unit is awarded cost-free and provides the owner with a conditional right to receive one share in Genmab A/S of nominally DKK 1. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genma ...
Genmab(GMAB) - 2024 Q3 - Earnings Call Transcript
2024-11-09 21:38
Financial Data and Key Metrics - Total revenue for the first nine months of 2024 reached over DKK 15 billion, a 29% increase compared to the previous year [34] - Recurring revenues grew by 37%, driven by strong royalties from DARZALEX, Kesimpta, and other approved medicines, as well as strong performance from EPKINLY and TIVDAK [28][29] - Operating profit stood at over DKK 4.5 billion, up more than 27% year-over-year [34] - Net profit for the period was almost DKK 4 billion, reflecting strong underlying financial performance [36] Business Line Performance - EPKINLY reported 17% growth in Q3, with global net sales of $82 million and year-to-date sales of $203 million [16] - TIVDAK demonstrated strong performance with 12 consecutive quarters of demand growth, achieving $32 million in sales [23] - EPKINLY and TIVDAK contributed 35% of Genmab's total revenue growth in the first nine months of 2024 [31] Market Performance - EPKINLY showed robust uptake in the U.S. and Japan, with strong field execution and positive responses from physicians and patients [17][22] - In Europe and the rest of the world, EPKINLY also saw strong growth through the partnership with AbbVie [22] - TIVDAK's demand growth was driven by the strength and breadth of accounts using the product, particularly in the gynecologic oncology space [23] Strategic Direction and Industry Competition - The company is focusing on maximizing the potential of its Phase 3 programs, including EPKINLY, Rina-S, and acasunlimab [12][32] - Genmab has terminated early-stage clinical programs (GEN1047, GEN3017, and GEN1056) and will not proceed with Phase 3 development for TIVDAK in second-line plus head and neck cancer [11] - The acquisition of ProfoundBio has enhanced Genmab's long-term growth potential, particularly in next-generation ADC platforms [27][43] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong performance of EPKINLY and TIVDAK, with consistent quarter-over-quarter growth [14][25] - The company expects continued strong growth for its own medicines, with around DKK 1.4 billion of growth from EPKINLY and TIVDAK in 2024 [38] - Genmab is committed to investing in Phase 3 trials for EPKINLY, Rina-S, and acasunlimab in 2025 [41] Other Important Information - The company plans to submit data for HexaBody-CD38 to J&J by the end of December 2024, with an opt-in decision expected by Q1 2025 [44] - Genmab will hold its annual R&D updates and data review event on December 11, 2024, which will be fully virtual [45] Q&A Session Summary Question: HexaBody-CD38 Data Disclosure - The top-line data for HexaBody-CD38 will be disclosed in the press release when J&J makes the opt-in decision, not at the time of data submission [47] Question: Rina-S and FR Alpha Expression - Rina-S has shown activity regardless of folate receptor alpha expression levels, with responses observed even in patients with expression below 25% [48] Question: TIVDAK Phase 3 Discontinuation - The decision to discontinue the Phase 3 trial for TIVDAK in head and neck cancer was based on strategic prioritization of the pipeline [52] Question: EPKINLY Commercial Potential - EPKINLY's major growth drivers are expected to be in the U.S. and Japan, with potential new approvals in follicular lymphoma (FL) and earlier lines of therapy [65] Question: 2025 Catalysts - Genmab expects further data on acasunlimab in lung cancer and updated data on Rina-S in ovarian carcinoma and other tumors in 2025 [69] Question: TIVDAK Cost Savings - The discontinuation of the TIVDAK Phase 3 trial will allow the company to reallocate resources to other Phase 3 programs, though specific cost savings were not detailed [70] Question: GEN1042 Next Steps - Genmab is collecting data on GEN1042 and will make a decision on next steps in the coming months [58] Question: HexaBody-CD38 Safety Profile - The company will not discuss HexaBody-CD38 safety data until J&J makes its opt-in decision [59] Question: Rina-S in Other Tumor Indications - Rina-S has shown activity in endometrial and non-small cell lung cancer, with potential for broader application across tumor types [84] Question: TIVDAK and KEYTRUDA Combination - The innovaTV 207 trial, exploring TIVDAK in combination with KEYTRUDA in frontline head and neck cancer, is ongoing [89] Question: Rina-S Trial Design - The Rina-S Phase 3 trial will not preselect patients based on folate receptor expression, though expression will be assessed in all patients [93] Question: Pipeline Reprioritization - Genmab has reprioritized its pipeline, discontinuing programs that did not meet internal differentiation criteria, while adding new programs like GEN1057 [100][101] Question: EPKINLY Patient Profile Evolution - EPKINLY is seeing broader patient populations, including those in earlier lines of therapy, with positive feedback from healthcare providers [102][103] Question: Autoimmune Disease Platform - Genmab is exploring innovative approaches to autoimmune diseases, including T-cell engagers and ADCs, though the focus remains on oncology for the near term [109][110]
Genmab(GMAB) - 2024 Q3 - Quarterly Report
2024-11-06 16:11
Exhibit 99.1 Genmab Announces Financial Results for the First Nine Months of 2024 November 6, 2024 Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2024 Highlights "The third quarter of 2024 presented Genmab with additional opportunities to progress towards our goal of fundamentally transforming the lives of people with cancer and other serious diseases. The additional approval for TEPKINLY, along with positive data presentations for our promising late-stage assets acasunlim ...
Genmab Announces Financial Results for the First Nine Months of 2024
GlobeNewswire News Room· 2024-11-06 16:02
November 6, 2024 Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2024 Highlights European Commission (EC) granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapyGenmab announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimabGenmab revenue inc ...
Genmab Announces Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2024
GlobeNewswire News Room· 2024-10-15 10:25
Company Performance - Worldwide net trade sales of DARZALEX® in Q3 2024 totaled USD 3,016 million, with USD 1,684 million in the U.S. and USD 1,332 million in the rest of the world [1] - Genmab receives royalties on worldwide net sales of DARZALEX®, including both intravenous and subcutaneous products, under an exclusive license to Janssen Biotech, Inc [1] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics to improve patient lives [2] - The company has a 25-year history of inventing next-generation antibody technology platforms, including bispecific T-cell engagers, antibody-drug conjugates, and immune checkpoint modulators [2] - Genmab's vision is to transform the lives of people with cancer and serious diseases by 2030 through its KYSO® antibody medicines [2] Corporate Structure - Genmab was established in 1999 and is headquartered in Copenhagen, Denmark [3] - The company has an international presence across North America, Europe, and Asia Pacific [3]
Major Shareholder Announcement
GlobeNewswire News Room· 2024-10-04 17:55
Company Announcement - Genmab A/S announces that Baillie Gifford & Co holds voting rights to 3,301,530 shares, representing 4.99% of the share capital and voting rights as of October 3, 2024 [1] About Genmab - Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [2] - The company has developed next-generation antibody technology platforms, including bispecific T-cell engagers and antibody-drug conjugates, leveraging data sciences for its proprietary pipeline [2] Company Background - Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with a presence in North America, Europe, and Asia Pacific [3]
TEPKINLY® (epcoritamab) Receives Second European Commission Approval for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma
GlobeNewswire News Room· 2024-08-19 18:00
Company Announcement TEPKINLY is the first and only subcutaneous bispecific antibody approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy COPENHAGEN, Denmark; August 19, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the trea ...