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 | ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2024 reached over DKK 4.1 billion, representing a 46% year-over-year increase [47] - Recurring revenue grew by 42% in Q1, driven by strong royalties from DARZALEX, KESIMPTA, and other approved medicines, as well as net product sales for EPKINLY [45][22] - Operating profit exceeded DKK 800 million, up more than 90% compared to the previous year [47] Business Line Data and Key Metrics Changes - DARZALEX net sales were just under US$ 2.7 billion in Q1, reflecting a 19% year-over-year growth, primarily from frontline multiple myeloma share gains [15] - KESIMPTA achieved net sales of $637 million in Q1, marking a 66% year-over-year growth [16] - EPKINLY generated US$ 54 million in net sales for Q1, with over 90% coming from strong launch performance in the U.S. and Japan [17] - Tivdak delivered $27 million in net sales for Q1, marking the 10th consecutive quarter of demand growth [42] Market Data and Key Metrics Changes - DARZALEX's new patient share in frontline therapy is now 53%, showing over 14% absolute growth compared to the same time last year [91] - KESIMPTA continues to lead in new-to-brand share in seven of the ten major markets outside the U.S. [16] Company Strategy and Development Direction - The proposed acquisition of ProfoundBio is expected to enhance the company's mid to late-stage clinical pipeline and strengthen capabilities in the ADC space [30] - The company anticipates strong revenue growth of 19% for 2024, driven by royalty medicines and significant contributions from EPKINLY and Tivdak [24] - The focus remains on oncology, with plans to prioritize opportunities in this area while also exploring immunology and inflammation [78] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential of EPKINLY and Tivdak, which are expected to drive nearly 40% of total revenue growth in 2024 [24] - The company is committed to investing in R&D to support the advancement of its clinical programs, particularly for EPKINLY and Tivdak [49] - Management highlighted the importance of regulatory approvals and successful launches for future growth [45] Other Important Information - The FDA granted priority review for EPKINLY as a treatment for relapsed or refractory follicular lymphoma, with a PDUFA date of June 28 [9] - The company plans to update overall guidance no later than the second quarter 2024 earnings [58] Q&A Session Summary Question: Insights on recent FDA MRD negativity in first-line myeloma - Management noted that MRD negativity is beneficial for patients and allows for the development of novel mechanisms in frontline therapy [67] Question: Updates on GEN1046 and ASCO data - Management confirmed that they are operationalizing towards activating the study by the end of the year and emphasized the importance of overall survival as a key endpoint [68] Question: Thoughts on business development priorities - The focus remains on oncology, particularly the ProfoundBio acquisition, while also considering opportunities in immunology [78] Question: Competitive landscape for DARZALEX - Management indicated that while there are new competitors, DARZALEX has established a strong presence in earlier lines of therapy [116] Question: EPKINLY's market penetration and community adoption - Management reported a modest shift towards community practices, with ongoing efforts to expand usage beyond major academic centers [140]

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 ...