Company Announcement Genmab to assume sole responsibility for the continued development and potential commercialization of acasunlimab BioNTech has opted not to participate in the further development of the acasunlimab program under the parties' existing collaboration agreement The overall collaboration between the companies to continue unchanged COPENHAGEN, Denmark; August 5, 2024 – Genmab A/S (NASDAQ:GMAB) announced today that it will assume sole responsibility for the continued development and potential ...

The biotechnology industry had a rough first-half 2024 after a decent performance in 2023. The majority of biotech players do not generate enough revenues to fund their operations and are dependent on external funds. A biotech company starts generating revenues following a successful FDA approval and the launch of any drug. Under this circumstance, a high interest rate regime is detrimental to the biotech industry. The primary reason for the industry's weak performance year to date is that the Fed refrained ...

"Many people living with follicular lymphoma that has either relapsed or is refractory to existing therapies experience significant treatment challenges with poor prognosis," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This positive opinion recognizes the unmet need in the European Union for patients whose follicular lymphoma is considered difficult-to-treat and that epcoritamab may represent a new therapeutic option." Positive CHMP opinion based on results from the Phase 1/2 EPCORE® ...

Company Announcement COPENHAGEN, Denmark; June 28, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY®), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or ...

COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) announces that itsshare buy-back program has been completed on June 26, 2024. The share buy-back program was expected to be completed no later than December 16, 2024. Details of each transaction are included as an appendix to this announcement. The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 ('MAR') and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." ...

Company Announcement Approval based on results from Phase 1/2 EPCORE® NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients with challenging-to-treat R/R FL EPKINLY offers an off-the-shelf, T-cell engaging treatment option that enables treatment across practice settings to address high clinical need EPKINLY is the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell ly ...

Company Announcement COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. With this approval, EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population. This indication is ap ...

Company Announcement COPENHAGEN, Denmark; May 21, 2024 – Genmab A/S (Nasdaq: GMAB). On March 15, 2024, Genmab announced the initiation of a share buy-back program to repurchase up to DKK 3.5 billion worth of shares. The share buy-back program is expected to be completed no later than December 16, 2024. The following transactions were executed under the program from May 13, 2024 to May 17, 2024: | | Trading Platform | No. of | Average price | Total value (DKK) | | --- | --- | --- | --- | --- | | | | shares | ...

财务数据和关键指标变化 - 公司总收入在第一季度达到40.1亿丹麦克朗,同比增长46% [37][40] - 经常性收入(包括版税和自有产品销售)同比增长42% [36][37] - 经营利润达到8.15亿丹麦克朗,同比增长超过90% [40] - 净利润为13.3亿丹麦克朗 [41] 各条业务线数据和关键指标变化 - DARZALEX销售额达到27亿美元,同比增长19%,主要来自于在一线多发性骨髓瘤的市场份额增长 [22][23] - KESIMPTA销售额达到6.37亿美元,同比增长66%,在美国以外的10个主要市场中有7个成为新品种的市场份额领导者 [24] - TECVAYLI、TALVEY和RYBREVANT等新上市的DuoBody双特异性抗体产品也实现了强劲增长 [25] - 自有商业化产品EPKINLY第一季度销售54百万美元,主要来自于美国和日本的强劲上市表现 [26][27] - TIVDAK第一季度销售27百万美元,连续第10个季度实现需求增长 [29] 各个市场数据和关键指标变化 - EPKINLY在美国和日本的上市表现强劲 [26][27] - TIVDAK在美国和日本的销售持续增长 [29][30] 公司战略和发展方向及行业竞争 - 公司拟收购ProfoundBio,将进一步增强公司在ADC领域的能力,并有望在2027年获得Rina-S的首次批准 [7][8][44] - 公司正在加快推进EPKINLY在弥漫大B细胞淋巴瘤和滤泡性淋巴瘤的临床开发 [10][11][27] - TIVDAK在美国获得了转换为正式批准的首个ADC,并已在日本提交新药申请 [12][14][30] - 公司正在与BioNTech合作开发GEN1046,计划于2024年底启动关键性试验 [18][57][58][59] 管理层对经营环境和未来前景的评论 - 公司保持了强劲的经营业绩和财务状况,为未来的投资和发展奠定了坚实的基础 [36][37][48] - 公司将继续专注于肿瘤领域,同时也在关注免疫和炎症领域的机会 [68] - 公司将继续保持高度的投资纪律,同时也不会回避对具有高潜力的中后期管线进行必要投资 [133][134][136] 问答环节重要的提问和回答 问题1 **Sachin Jain 提问** 对于DARZALEX在一线多发性骨髓瘤中MRD阴性数据的影响,以及这对J&J在决定是否继续开发HexaBody的关键决策指标有何影响 [54] **Tahi Ahmadi 回答** MRD阴性数据为多发性骨髓瘤的新药开发提供了新的机会,J&J也认识到这一点。公司将继续推进HexaBody的开发 [57][58] 问题2 **Vikram Purohit 提问** 对于GEN3014,公司何时会公布数据,以及J&J做出决定的时间窗口 [66][67] **Tahi Ahmadi 回答** 公司已经与J&J明确约定了数据集和时间窗口,预计将在今年年底前公布数据,J&J将在数据公布后的相对较短时间内做出决定 [68][69] 问题3 **Xian Deng 提问** 对于GEN1046的安全性,尤其是肝毒性方面的长期数据,以及ASCO会议上的数据截止时间和临床试验设计 [74][75][76] **Tahi Ahmadi 回答** 目前GEN1046的肝毒性数据显示是可控的,没有观察到累积性肝毒性。ASCO会议上将公布更新的数据,临床试验设计将探索PD-L1阳性患者群体 [79][80][81]

Quarter End Results Forward looking 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 (including development plans and objectives relating to our ...