Core Insights - Genmab A/S announced FDA approval for EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma, based on the Phase 3 EPCORE FL-1 study results [2][7][9] Group 1: Study Results - EPKINLY + R reduced the risk of disease progression or death by 79% compared to standard treatment R, with a hazard ratio of 0.21 [3] - The median progression-free survival (PFS) was not reached for EPKINLY + R, while it was 11.2 months for R [3] - Among patients treated with EPKINLY + R, 89% responded to treatment and 74% achieved a complete response, compared to 74% overall response rate and 43% complete response rate for R [3] Group 2: Safety Profile - The safety profile of EPKINLY + R was consistent with known safety profiles of the individual components, with common adverse reactions including rash, upper respiratory infections, and fatigue [4] - Cytokine release syndrome (CRS) occurred in 24% of patients, primarily low grade, with a single event of immune effector cell-associated neurotoxicity syndrome (ICANS) reported [4][21] Group 3: Industry Impact - The approval of EPKINLY + R represents a significant advancement for patients with follicular lymphoma, providing a chemotherapy-free treatment option that can be administered in outpatient settings [5][6] - Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma affecting approximately 15,000 new patients annually in the U.S., with current therapies considered incurable [5][26] Group 4: Future Prospects - EPKINLY + R is the first bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line setting, marking the third indication for EPKINLY [7] - Genmab and AbbVie are continuing to evaluate epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials [29][28]

Core Points - Genmab A/S announced plans to offer $1.5 billion of senior secured notes due 2032 and $1.0 billion of senior unsecured notes due 2033, alongside a new $2.0 billion senior secured term loan "B" facility [1] - The financing is part of the acquisition of Merus N.V., which includes previously syndicated credit facilities totaling $1.5 billion [1] - A preliminary offering memorandum has been provided to potential investors, containing undisclosed information and pro forma financial data related to the acquisition [2] Financial Information - The preliminary offering memorandum includes unaudited pro forma condensed combined financial information for the nine months ended September 30, 2025, and for the year ended December 31, 2024 [2] - Audited consolidated financial statements for the years ended December 31, 2024, 2023, and 2022 are also included, originally prepared in Danish Kroner and retranslated into US Dollars [2]

Core Viewpoint - Genmab A/S announced plans to offer $1.5 billion of senior secured notes due 2032 and $1.0 billion of senior unsecured notes due 2033 to finance the acquisition of Merus N.V. [1][2][3] Financing Details - The company is launching a new $2.0 billion senior secured term loan "B" facility, in addition to a previously syndicated $1.0 billion senior secured term loan "A" facility and a $500 million senior secured revolving credit facility [2] - The net proceeds from the offering of the Notes, along with borrowings under the New Credit Facilities and cash on hand, will be used to fund the acquisition of Merus and related expenses [3] Security and Guarantees - Prior to the acquisition closing, the Notes will be secured by segregated securities accounts of Genmab, with the gross proceeds held therein [4] - After the acquisition, the Secured Notes will be secured by a first priority security interest in certain assets of Genmab and its subsidiaries [4] Indenture Covenants - The indentures governing the Notes are expected to include customary covenants that restrict Genmab and its subsidiaries from incurring additional debt, paying dividends, and engaging in certain transactions without exceptions [5] Regulatory Information - The Notes will not be registered under the Securities Act of 1933 and will only be available to qualified institutional buyers or non-U.S. persons outside the United States [6]

Financial Data and Key Metrics Changes - Total revenue grew by 21% year-over-year, driven by increased recurring revenue, with recurring revenue up 26% [5][22][24] - Operating profit increased by 52%, reflecting strong financial performance despite strategic investments [5][25] - The company ended the first half of 2025 with approximately $3.4 billion in cash, providing flexibility for growth and expansion [5] Business Line Data and Key Metrics Changes - Sales from Epkinly and TIVDAK increased by 54% year-over-year, contributing 25% to total revenue growth [15][22] - Epkinly sales reached $333 million through Q3, representing a 64% year-over-year increase, establishing it as a leader in the third-line setting for diffuse large B-cell lymphoma and follicular lymphoma [17][19] - TIVDAK sales totaled $120 million year-to-date, with strong performance in both new and established markets [20] Market Data and Key Metrics Changes - Epkinly has received regulatory approvals in over 65 countries, with more than 50 countries now having dual indications [19] - The company is preparing for the launch of Epkinly in earlier lines of therapy, particularly in second-line follicular lymphoma, with an estimated 9,000 patients in this segment [42] Company Strategy and Development Direction - The proposed acquisition of Merus is seen as a transformative opportunity, advancing the company's evolution into a global biotech leader and expanding its revenue base [6][30] - The company aims to maximize the potential of its commercialized medicines while accelerating the development of its late-stage pipeline [5][6] - The focus remains on high-impact programs, with ongoing phase 3 trials for rinatabart sesutecan and Petosemtamab expected to drive future growth [7][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of rinatabart sesutecan and Petosemtamab as key growth drivers, with expectations for significant market opportunities [7][36] - The company anticipates continued strong performance and is on track to achieve double-digit revenue and profit growth for 2025 [26][28] Other Important Information - The company has initiated additional phase 3 clinical trials for rinatabart sesutecan, reinforcing its commitment to advancing its innovative pipeline [11][29] - The annual R&D updates and data review will be held virtually on December 11, 2025 [31] Q&A Session Summary Question: Competitive landscape of Petosemtamab and Rinatabart sesutecan - Management remains confident in the positioning of both drugs as best-in-class assets, with ongoing phase 3 trials supporting their development [34][36] Question: Commercial dynamics of Epkinly - The dual indication of Epkinly is beneficial for operationalization, and the company expects significant growth opportunities in earlier lines of therapy [40][41] Question: Termination of clinical development for 1042 - The decision was based on data not meeting internal development standards, leading to a halt in the program [51][52] Question: Confidence in Epkinly's upcoming PDUFA - Management expressed high confidence in the approval process, with no indications suggesting otherwise [55][57] Question: OpEx and profitability outlook for 2026 - The company maintains a disciplined investment approach, with expectations for significant profitability and operational efficiency [62][66]

Quarter End Results As part of Genmab's First Nine Months 2025 Financial Results presentation, we will discuss several products developed in collaboration with strategic partners or that are the result of product or technology licenses with other companies. This slide is an acknowledgement of those relationships. Period Ended September 30, 2025 © Genmab 2025 Forward looking statement This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and s ...

Financial Performance - Genmab's revenue for the first nine months of 2025 increased by 21% to $2,662 million compared to $2,198 million in the same period of 2024[5]. - Royalty revenue rose by 23% to $2,219 million, driven by higher net sales of DARZALEX and Kesimpta[6]. - Net sales of DARZALEX reached $10,448 million, an increase of 22% from $8,586 million in the first nine months of 2024[6]. - Operating profit for the first nine months of 2025 was $1,007 million, compared to $662 million in the same period of 2024[6]. - The company reported a net profit of $932 million for the first nine months of 2025, compared to $581 million in the same period of 2024[11]. - Genmab's total revenue for the third quarter of 2025 was $1,022 million, a 25% increase from $816 million in the third quarter of 2024[92]. - Total comprehensive income for the nine months ended September 30, 2025, was $954 million, compared to $584 million in 2024, reflecting a 63% increase[143]. Revenue Guidance and Projections - Genmab is maintaining its 2025 revenue guidance in the range of $3.5 billion to $3.7 billion[12]. - The projected royalties from DARZALEX are expected to be between $2.3 billion and $2.4 billion, based on estimated net sales of $13.7 billion to $14.1 billion[14]. - Genmab's operating profit guidance for 2025 is set between $1.1 billion and $1.4 billion[16]. Product Development and Pipeline - At the end of Q3 2025, Genmab's proprietary pipeline included nine antibody products in clinical development, with a focus on Epcoritamab and Tivdak[19]. - Epcoritamab (EPKINLY/TEPKINLY) has received regulatory approvals in multiple territories, including the U.S., Europe, and Japan, for adult patients with relapsed or refractory DLBCL and FL after two or more lines of systemic therapy[23]. - More than 40 clinical trials are ongoing for Epcoritamab across various treatment settings, including five Phase 3 trials[23]. - Tivdak is the first and only ADC approved for recurrent or metastatic cervical cancer in the U.S., Europe, and Japan, co-developed with Pfizer[27]. Collaborations and Acquisitions - The proposed acquisition of Merus is valued at approximately $8.0 billion, expected to close in early 2026[7]. - Genmab's collaboration with AbbVie for Epcoritamab includes shared commercialization responsibilities in the U.S. and Japan[24]. - Genmab completed the acquisition of ProfoundBio for a total consideration of $1.905 billion, including $1.718 billion for outstanding shares and $187 million for equity compensation[154]. Expenses and Costs - Total costs and operating expenses increased by 8% to $1,655 million, primarily due to the expansion of the product pipeline[6]. - Research and development expenses were $1,080 million in the first nine months of 2025, a 5% increase from $1,032 million in the same period of 2024[98]. - Selling, general and administrative expenses rose to $418 million in the first nine months of 2025, a 13% increase from $370 million in the first nine months of 2024[102]. Cash Flow and Financial Position - Net cash provided by operating activities rose by $148 million to $885 million for the nine months ended September 30, 2025, driven by a $340 million increase in net profit before tax[121]. - Cash and cash equivalents, including short-term marketable securities, totaled $1,761 million as of September 30, 2025, compared to $1,380 million on December 31, 2024[140]. - Shareholders' equity increased by $614 million, or 12%, to $5,751 million as of September 30, 2025, compared to $5,137 million on December 31, 2024[129]. Market and Regulatory Environment - Genmab faces risks related to evolving trade policies and potential delays in regulatory reviews that could impact clinical milestones and product launches[70]. - The FDA accepted for priority review the sBLA for Epcoritamab in combination with R for relapsed or refractory FL, with a target action date of November 30, 2025[28].

Core Insights - Genmab has made significant advancements in its late-stage portfolio, with Epcoritamab nearing availability for earlier treatment lines in follicular lymphoma and Rina-S receiving Breakthrough Therapy Designation for advanced endometrial cancer [2][6] - The proposed acquisition of Merus is expected to enhance Genmab's late-stage pipeline by adding petosemtamab, which has two Breakthrough Therapy Designations, and is anticipated to drive sustained growth into the next decade [2][8] Financial Performance - Genmab's revenue for the first nine months of 2025 reached $2,662 million, a 21% increase from $2,198 million in the same period of 2024, primarily driven by higher royalties from DARZALEX and Kesimpta, as well as increased net product sales of EPKINLY [6][7] - Royalty revenue increased to $2,219 million in the first nine months of 2025, up from $1,802 million in the same period of 2024, marking a 23% rise [7] - Operating profit for the first nine months of 2025 was $1,007 million, compared to $662 million in the same period of 2024 [7] Strategic Outlook - Genmab is maintaining its financial guidance for 2025 as published on August 7, 2025 [4] - The company has transitioned its functional and presentation currency from DKK to USD effective January 1, 2025, with retrospective adjustments made to prior periods [5] Acquisition Details - Genmab intends to acquire Merus for $97.00 per share in an all-cash transaction valued at approximately $8.0 billion, funded through cash on hand and $5.5 billion of non-convertible debt financing [8] - The acquisition is expected to close by early Q1 2026, subject to customary closing conditions [8]

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] Upcoming Events - Genmab's CEO Jan Van de Winkel and CFO Anthony Pagano will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on November 19, 2025, at 12:00 PM GMT [1] - A webcast of the event will be available on Genmab's website [1] Strategic Vision - By 2030, Genmab aims to transform the lives of individuals with cancer and other serious diseases through its innovative antibody medicines, referred to as "knock-your-socks-off" (KYSO) therapies [2]

Core Insights - Genmab A/S announced the presentation of over 20 abstracts on epcoritamab, a T-cell engaging bispecific antibody, at the upcoming American Society of Hematology (ASH) meeting, highlighting its potential in treating various B-cell non-Hodgkin's lymphoma subtypes [2][4]. Clinical Data and Presentations - The data from the epcoritamab development program will demonstrate its expanding clinical profile, particularly in earlier lines of therapy with a fixed treatment duration [3][7]. - Key presentations will include oral sessions on the efficacy of epcoritamab in first- and second-line settings for follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) [3][7]. - The Phase 3 EPCORE FL-1 trial results, evaluating epcoritamab in combination with rituximab and lenalidomide for relapsed or refractory FL, will be shared [4][7]. Event Details - Genmab will host a virtual 2025 R&D Update and ASH Data Review on December 11, 2025, to discuss the findings further [5]. - All abstracts accepted for presentation have been published and are accessible on the ASH website [6]. Abstract Highlights - The abstracts include significant findings such as high response rates and minimal residual disease (MRD) negativity in elderly patients with newly diagnosed LBCL [6][9]. - Additional presentations will cover the long-term efficacy of epcoritamab in various treatment combinations and settings, including its use as monotherapy for patients with Richter transformation [8][9]. Company Overview - Genmab is focused on developing epcoritamab as a core therapy for a range of B-cell malignancies, showcasing its commitment to advancing treatment options in hematologic cancers [4][14]. - The company is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, while pursuing further global regulatory approvals [14][15].

Core Insights - Genmab A/S is highlighted as one of the most profitable biotech stocks to consider for investment, with a Buy rating maintained by H.C. Wainwright analyst Ram Selvaraju and a price target set at $40 [1][2]. Group 1: Clinical Developments - The company has shown promising clinical developments, particularly with rinatabart sesutecan (Rina-S) for endometrial cancer, which demonstrated notable response rates in patients regardless of OFRα expression levels [2][3]. - These results are particularly encouraging when compared to existing treatments, which exhibit lower overall response rates, such as the combination of ELAHERE and Keytruda [3]. Group 2: Product Pipeline - Genmab A/S is an international biotechnology company focused on developing human antibody therapeutics for cancer and other diseases [4]. - The company's product pipeline includes DARZALEX for multiple myeloma, TEPEZZA for thyroid eye disease, and Arzerra for chronic lymphocytic leukemia [4].