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]

Financial Performance - Total revenue grew by 21% to USD 2,662 million for the first nine months of 2025 [43] - Operating profit increased by 52% to USD 1,007 million for the first nine months of 2025 [12, 43] - Recurring revenue grew by 26% for the first nine months of 2025 [43] - Combined commercialized medicines sales increased by 54% to USD 453 million for the first nine months of 2025 [28] Product Performance - EPKINLY net sales reached USD 333 million, a 64% increase year-over-year for the first nine months of 2025 [31] - TIVDAK net sales reached USD 120 million, a 30% increase year-over-year for the first nine months of 2025 [36] Strategic Initiatives - The company is planning to acquire Merus to deliver the next decade of sustainable growth [12, 14] - The company anticipates a first launch for petosemtamab in 2027 [17] Rina-S® Data - Rina-S® 100mg/m2 led to a confirmed ORR of 50% and a DCR of 100% in patients with advanced or recurrent endometrial cancer [26]

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].

Core Points - Genmab A/S is initiating a cash tender offer to acquire all outstanding common shares of Merus N.V. for $97.00 per share [1] - The offer is part of a transaction agreement dated September 29, 2025, between Genmab, its subsidiary, and Merus [1] - Merus's Board of Directors has recommended that shareholders accept the offer [2] Offer Details - The tender offer will expire at 5:00 p.m. New York City time on December 11, 2025, unless extended [3] - If conditions are met, a subsequent offering period will commence on the first business day following the expiration [3] - The offer is not subject to a financing condition but is subject to other conditions, including a minimum tender condition [4] Shareholder Information - Merus shareholders are advised to review the tender offer documents filed with the SEC before deciding to tender their shares [5] - These documents can be accessed for free on the SEC's website or through the information agent for the tender offer [5] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics [6] - The company has a vision to transform the lives of patients with cancer and serious diseases through advanced antibody medicines by 2030 [6] - Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with a global presence [7]

Core Insights - Genmab A/S announced updated data from the Phase 1/2 RAINFOL-01 trial for rinatabart sesutecan (Rina-S) in advanced endometrial cancer patients, showing a 50.0% confirmed objective response rate (ORR) at a median follow-up of one year [1][3][5] Study Results - The study involved 64 heavily pretreated patients with advanced or recurrent endometrial cancer, with 50% ORR in the 100 mg/m² cohort, including two complete responses (CRs) [5] - In the 120 mg/m² cohort, the confirmed ORR was 44.1%, with one CR observed [6] - Among responders in the 100 mg/m² cohort, 63.6% maintained their responses at the one-year follow-up [3] Ongoing Trials - Continued evaluation of Rina-S is ongoing in the Phase 2 RAINFOL-01 trial and the Phase 3 RAINFOL-03 trial, focusing on its efficacy and safety in advanced or recurrent endometrial cancer [4] Safety Profile - Common treatment emergent adverse events (TEAEs) included cytopenias and low-grade gastrointestinal events, with no signals of ocular toxicities, neuropathy, or interstitial lung disease reported [6] Market Reaction - Following the announcement, Genmab's stock price decreased by 6.57%, trading at $30.99 [7]

Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 0.2% on Monday [1] Company-Specific Movements - Olema Pharmaceuticals Inc (NASDAQ:OLMA) shares fell 18.3% to $7.64 in pre-market trading following the announcement of new data from the Phase 1b/2 trial of palazestrant plus ribociclib in ER+/HER2- metastatic breast cancer at ESMO 2025 [1] - Concord Medical Services Hldgs Ltd (NYSE:CCM) experienced a decline of 24.4% to $4.15 in pre-market trading after a 6% drop on Friday [3] - Addex Therapeutics Ltd – ADR (NASDAQ:ADXN) dipped 15.6% to $9.23 in pre-market trading after a significant gain of 28% on Friday [3] - Exelixis Inc (NASDAQ:EXEL) shares fell 8.3% to $36.00 after announcing detailed results from the Phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with an immune checkpoint inhibitor in metastatic colorectal cancer, presented at ESMO 2025 and published in The Lancet [3] - Cellectis SA (NASDAQ:CLLS) shares declined 7.3% to $3.69 in pre-market trading [3] - Alumis Inc (NASDAQ:ALMS) saw a decline of 6.7% to $4.19 in pre-market trading [3] - Nanobiotix SA – ADR (NASDAQ:NBTX) fell 6.3% to $23.98 in pre-market trading after a 4% decline on Friday [3] - Genmab A/S – ADR (NASDAQ:GMAB) declined 4.1% to $31.81 in pre-market trading, with Rinatabart Sesutecan achieving a 50% objective response rate and two complete responses in advanced endometrial cancer [3] - Taysha Gene Therapies Inc (NASDAQ:TSHA) fell 4% to $4.53 in pre-market trading [3]