Company Overview - Genmab A/S is an international biotechnology company focused on improving patient lives 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 Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 7:45 AM EDT [1] Strategic Vision - By 2030, Genmab aims to transform the lives of patients with cancer and other serious diseases through its proprietary pipeline, which includes bispecific T-cell engagers, antibody-drug conjugates, and next-generation immune checkpoint modulators [2]

Core Perspective - Genmab A/S announced that the U.S. FDA has granted Breakthrough Therapy Designation to rinatabart sesutecan (Rina-S) for treating adult patients with recurrent or progressive endometrial cancer who have experienced disease progression after prior treatments [2][7] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform the lives of patients with cancer and other serious diseases by 2030 [10][11] Product Development - Rina-S is an investigational antibody-drug conjugate targeting folate receptor alpha (FRα) and is currently undergoing late-stage development, including ongoing Phase 1/2 and Phase 3 trials for various cancers [4][8] - The Breakthrough Therapy Designation is supported by results from the Phase 1/2 RAINFOL™-01 trial, which showed encouraging responses in heavily pretreated endometrial cancer patients [3][7] Clinical Trial Insights - The RAINFOL™-01 trial is an open-label, multicenter study designed to evaluate the safety and efficacy of Rina-S in solid tumors expressing FRα, with multiple cohorts focusing on different cancer types [5][8] - The trial's B2 cohort included 64 patients with advanced or recurrent endometrial cancer who had progressed after anti-PD-(L)1 and platinum-based chemotherapy [3][6] Market Context - Endometrial cancer is the second most prevalent gynecologic cancer globally, with increasing incidence and limited treatment options for advanced cases, highlighting the need for innovative therapies like Rina-S [6][8]

Core Insights - Genmab A/S has released results from the Phase 3 EPCORE FL-1 trial, showing that subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) significantly improves outcomes for adult patients with relapsed or refractory follicular lymphoma [1][2] Study Results - The trial met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating a 79% reduction in the risk of disease progression or death [2] - Results will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will support global regulatory submissions [3] Regulatory Developments - The U.S. FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2, based on significant ORR and PFS improvements from interim analysis [4] - The FDA has set a target action date of November 30, 2025, for the sBLA [5] Market Performance - Genmab reported revenue of $1.64 billion for the first half of 2025, up from $1.38 billion year-over-year, with second-quarter sales of $925 million exceeding consensus estimates [6] - The 19% revenue increase was driven by higher royalties from collaborations and increased sales of Epkinly [7] - The company raised its fiscal year 2025 sales guidance to between $3.5 billion and $3.7 billion, surpassing consensus expectations [7]

Core Viewpoint - Genmab A/S Sponsored ADR (GMAB) has seen a 3.8% increase in share price over the past four weeks, closing at $22.69, with a potential upside of 33.8% based on Wall Street analysts' mean price target of $30.36 [1] Price Targets - The average price target consists of seven estimates ranging from a low of $20.00 to a high of $46.00, with a standard deviation of $8.82, indicating variability among analysts [2] - The lowest estimate suggests an 11.9% decline from the current price, while the highest estimate indicates a 102.7% upside [2] Analyst Sentiment - Analysts show a consensus that GMAB will report better earnings than previously estimated, which historically correlates with stock price increases [4][11] - The Zacks Consensus Estimate for the current year has increased by 0.1% over the past month, with one estimate rising and no negative revisions [12] Zacks Rank - GMAB holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for upside [13] Conclusion on Price Targets - While the consensus price target may not be a reliable measure of the extent of GMAB's potential gains, it does provide a useful indication of the expected direction of price movement [14]

Financial Data and Key Metrics Changes - Total revenue grew by 19% in the first half of 2025, driven by increased recurring revenue [5][30] - Operating profit increased by 56%, reflecting strong financial performance despite strategic investments [6][35] - Cash reserves at the end of the first half were approximately $3 billion, providing flexibility for growth and expansion [6][30] - Recurring revenues represented 97% of total revenue, up from 90% in the same period last year [33] Business Line Data and Key Metrics Changes - Sales for Epkinley and TIVDAC increased by 60% year over year, contributing to 31% of total revenue growth [22][30] - Epkinley achieved $211 million in global sales, a 74% increase year over year [23] - TIVDAC sales totaled $78 million, reflecting a 30% increase compared to the previous year [27] Market Data and Key Metrics Changes - Epkinley received regulatory approvals in over 60 countries, with nearly 50 countries approving it for both DLBCL and FL indications [25] - The launch of Epkinley in Japan for third-line follicular lymphoma began in May, showing encouraging uptake [24][27] Company Strategy and Development Direction - The company aims to accelerate the development of its late-stage pipeline and maximize the potential of its commercialized medicines [5][39] - Plans to broaden the reach of RINA S with three Phase III trials expected to be underway by the end of the year [11][39] - The company is focused on expanding its pipeline both organically and inorganically to ensure sustainable long-term growth [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting strong financial foundations and disciplined capital allocation strategies [38][39] - The company anticipates continued growth for Epkinley and TIVDAC, with further data expected to support their market positions [39] Other Important Information - The FDA accepted the supplemental BLA for epiritamab with a target action date of November 30, 2025 [9][56] - The company is actively engaging with the FDA regarding regulatory submissions and believes there is no significant risk of pushback [56] Q&A Session Summary Question: Positioning of EPCO versus other CD20 bispecifics - Management feels confident about their broad and aggressive development plan, with a head start in second-line follicular lymphoma [44][45] - The company has received positive feedback from physicians and is encouraged by its leading sales position globally [48] Question: Confidence in filing RAINFALL-one for accelerated approval - Management is optimistic about filing for accelerated approval based on strong data and ongoing engagement with the FDA [55][56] Question: Initial launch strategy for Epkinley - The focus will be on earlier lines of therapy, particularly in the community setting, where uptake has been accelerating [63] Question: Development plans for RINA S outside ovarian cancer - The company is exploring RINA S in non-small cell lung cancer, with a Phase II study planned to assess both monotherapy and combination therapy [91][92] Question: Role of ADC combinations in lymphoma - Management sees potential for ADC combinations in diffuse large B cell lymphoma and believes bispecifics will become a backbone for novel combinations [87][88]

Financial Data and Key Metrics Changes - Total revenue grew by 19% in the first half of 2025, driven by increased recurring revenue [4][29] - Operating profit increased by 56%, reflecting strong financial performance despite strategic investments [5][33] - Cash reserves at the end of the first half were approximately $3 billion, providing flexibility for growth and expansion [5][29] - Recurring revenues represented 97% of total revenue, up from 90% in the same period last year [31] Business Line Data and Key Metrics Changes - Sales for Epkinley reached $211 million, a 74% year-over-year increase, contributing significantly to total revenue growth [22][29] - TIVDAC sales totaled $78 million, a 30% increase compared to the previous year, with strong performance in the US and Japan [26][29] - The growth of commercialized medicines is expected to increasingly contribute to overall revenue growth over time [21][29] Market Data and Key Metrics Changes - Epkinley has received regulatory approvals in over 60 countries, with nearly 50 countries approving it for both DLBCL and FL indications [24][29] - The FDA accepted the supplemental BLA for epiritamab with a target action date of November 30, 2025, indicating strong market potential [7][55] Company Strategy and Development Direction - The company aims to accelerate the development of high-impact late-stage programs and maximize the potential of commercialized medicines [4][39] - Plans to broaden the reach of RINA S with three Phase III trials expected to be underway by the end of the year [10][39] - The company is focused on expanding utilization of its medicines and bringing them to more patients globally [28][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting a strong financial foundation and disciplined capital allocation strategy [5][37] - The company anticipates continued growth in recurring revenues and operating profit, with improved financial guidance for 2025 [34][35] - Management is closely monitoring geopolitical situations but does not foresee significant impacts on financial guidance for 2025 [37] Other Important Information - The company completed a share buyback in June, reinforcing confidence in its future [5] - The Phase III Epcor FL1 trial met its dual endpoints, supporting the potential to transform treatment paradigms for patients [12][14] Q&A Session Summary Question: Positioning of EPCO versus other CD20 bispecifics - Management feels confident about their broad and aggressive development plan, with a head start in second-line follicular lymphoma [43][44] - They have received positive feedback from physicians and are moving into earlier lines of therapy [47][48] Question: Confidence in filing RAINFALL-one for accelerated approval - Management is confident in filing for accelerated approval based on strong data and ongoing engagement with the FDA [54][55] Question: Initial launch strategy for Epkinley - The focus will be on earlier lines of therapy, particularly in the community setting, with significant opportunities for patient expansion [62] Question: Development plans for RINA S outside ovarian cancer - The Phase II trial will explore RINA S in both monotherapy and combination settings, with a focus on EGFR mutated non-small cell lung cancer [93] Question: ADC combinations in lymphoma - Management sees potential for ADC combinations and believes bispecifics will become a backbone for novel combinations in the future [87][88]

Financial Performance - Total revenue increased by 19% from USD 1382 million to USD 1640 million[39] - Operating profit increased by 56% from USD 352 million to USD 548 million[39] - Recurring revenue grew by 27%[38] - Combined commercialized medicines sales increased by 60% from USD 181 million to USD 289 million[23] - Cash reserves stand at USD 29 billion[12] Product Performance - EPKINLY net sales increased by 74% to USD 211 million[27] - TIVDAK net sales increased by 30% to USD 78 million[32] - Rina-S® showed a confirmed ORR of 500% in endometrial cancer patients[17] Pipeline Development - EPCORE® FL-1 clinical trial met dual primary endpoints of ORR and PFS, reducing the risk of disease progression or death by 79%[14] - sBLA for EPKINLY® in 2L FL accepted with a PDUFA date of November 30, 2025[13] Guidance - Revenue guidance improved to USD 3500-3700 million, representing a 15% year-over-year growth[41] - Operating profit guidance improved to USD 1055-1405 million, representing a 26% year-over-year growth[41]

Financial Performance - Genmab's revenue for the first half of 2025 increased by 19% to $1,640 million, up from $1,382 million in the same period of 2024[11]. - Royalty revenue rose by 24% to $1,378 million, driven by higher net sales of DARZALEX and Kesimpta[11]. - Net sales of DARZALEX reached $6,776 million, a 22% increase from $5,570 million in the first half of 2024[11]. - Operating profit for the first half of 2025 was $548 million, compared to $352 million in the first half of 2024[13]. - Basic net profit per share for the first half of 2025 was $5.44, compared to $3.15 in the same period of 2024[19]. - Net profit for the first six months of 2025 was $531 million, an increase of 34% compared to $395 million in the same period of 2024[131]. - Revenue for Q2 2025 reached $925 million, a 19% increase from $779 million in Q2 2024[147]. - Net product sales for the first six months of 2025 were $176 million, compared to $109 million in the same period of 2024, marking a 62% increase[182]. Guidance and Projections - Genmab updated its full-year revenue guidance to a range of $3,500 - $3,700 million, with a midpoint of $3,600 million[14]. - Genmab expects 2025 revenue to be in the range of $3.5 - $3.7 billion, an increase from the previous guidance of $3.3 - $3.7 billion[21]. - Operating profit guidance for 2025 has been revised to a range of $1.1 - $1.4 billion, up from the previous range of $0.9 - $1.4 billion[24]. - Genmab maintains its operating expenses guidance for 2025 at $2.1 - $2.2 billion[23]. Research and Development - The company has a proprietary pipeline of 10 investigational medicines in clinical development, including EPKINLY and Tivdak[28]. - Epcoritamab (EPKINLY/TEPKINLY) is approved for certain B-cell malignancies in multiple territories, including the U.S., Europe, and Japan[32]. - The company is conducting over 40 clinical trials for Epcoritamab, including five Phase 3 trials[33]. - Acasunlimab (GEN1046) is in a Phase 3 trial for PD-L1 positive metastatic NSCLC, recruiting patients[42]. - GEN1042 (DuoBody-CD40x4-1BB) is co-developed with BioNTech, with ongoing clinical trials in solid tumors[47]. - GEN1160 is a CD70-targeted ADC currently in a Phase 1/2 clinical study for advanced renal cell carcinoma and nasopharyngeal carcinoma[51]. - GEN1286 is an ADC targeting EGFR and cMet, with a Phase 1/2 clinical study in advanced solid tumors currently recruiting[58]. Collaborations and Partnerships - Genmab's collaboration with AbbVie for Epcoritamab includes shared commercialization responsibilities in the U.S. and Japan[34]. - Genmab and Pfizer have a joint commercialization agreement for Tivdak, with Genmab leading operations outside the U.S. and China, while Pfizer leads in the U.S.[39]. - Genmab's collaboration with J&J focuses on developing bispecific antibodies using the DuoBody technology platform, leading to multiple approved therapies[81]. Financial Position - Total assets as of June 30, 2025, were $6,464 million, an increase from $6,414 million on December 31, 2024[137]. - Total liabilities decreased to $1,162 million as of June 30, 2025, from $1,277 million on December 31, 2024, a reduction of 9%[138]. - Shareholders' equity increased to $5,302 million as of June 30, 2025, up 3% from $5,137 million on December 31, 2024[139]. - Cash and cash equivalents at the end of Q2 2025 were $1,296 million, compared to $622 million at the end of Q2 2024[153]. Expenses and Costs - Total costs and operating expenses increased by 6% to $1,092 million, primarily due to pipeline expansion and profit-sharing amounts payable to AbbVie[13]. - Research and development expenses increased by 4% to $723 million in the first half of 2025, compared to $696 million in the same period of 2024, driven by the addition of ProfoundBio related expenses[109]. - Selling, general and administrative expenses rose by 11% to $270 million in the first half of 2025, compared to $243 million in the first half of 2024, primarily due to the expansion of commercialization capabilities[113]. Market and Sales Risks - The company anticipates risks related to sales performance of its products, including Tivdak and EPKINLY/TEPKINLY[26]. - Genmab's financial guidance is subject to change based on various factors, including collaboration milestones and market conditions[25]. - The company faces risks related to evolving trade policies and potential regulatory delays impacting clinical milestones and product launches[83].

Core Insights - Genmab has made significant progress in its strategic priorities, focusing on expanding access to innovative therapies and maximizing the potential of its commercialized medicines [2] - The company has updated its revenue and operating profit guidance for 2025, driven by increased royalty revenues from DARZALEX [4] Financial Performance - Revenue for the first half of 2025 reached $1,640 million, a 19% increase from $1,382 million in the same period of 2024, primarily due to higher royalties from DARZALEX and Kesimpta, as well as increased EPKINLY net product sales [6][7] - Royalty revenue was $1,378 million in the first half of 2025, up 24% from $1,111 million in the first half of 2024, attributed to higher net sales of DARZALEX and Kesimpta [7] - Operating profit for the first half of 2025 was $548 million, compared to $352 million in the first half of 2024 [7] 2025 Full Year Outlook - Revised revenue guidance for 2025 is set between $3,500 million and $3,700 million, with a midpoint of $3,600 million, an increase from the previous guidance of $3,340 million to $3,660 million [5] - Royalties are expected to be between $2,945 million and $3,090 million, with a midpoint of $3,017 million, up from the previous guidance of $2,785 million to $3,015 million [5] - Net product sales/collaboration revenue is projected to be between $425 million and $465 million, with a midpoint of $445 million [5] Pipeline Developments - Epcoritamab is advancing to earlier lines of therapy with a supplemental Biologics License Application (sBLA) submitted to the FDA for use in patients with relapsed or refractory follicular lymphoma [6] - Rina-S continues to show promising antitumor activity in endometrial cancer, with data presented at the 2025 ASCO Annual Meeting [6] Other Matters - Genmab has changed its functional currency and presentation currency from DKK to USD effective January 1, 2025, with retrospective adjustments made to prior periods [9]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE FL-1 trial for subcutaneous epcoritamab in combination with rituximab and lenalidomide, showing significant improvements in overall response rate (ORR) and progression-free survival (PFS) for patients with relapsed or refractory follicular lymphoma [2][6][4] - The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for epcoritamab plus rituximab, with a target action date of November 30, 2025, which could make it the first bispecific antibody combination available in the U.S. for second-line treatment of this condition [3][6] - Epcoritamab is designed to target CD3 on T cells and CD20 on B cells, facilitating T-cell-mediated killing of malignant B cells, and has received regulatory approval in various lymphoma indications [8][9] Trial Results - The EPCORE FL-1 trial met its dual primary endpoints, achieving an ORR of 95.7% (p-value < 0.0001) and a PFS hazard ratio of 0.21 (p-value < 0.0001), indicating a 79% reduction in the risk of disease progression or death [2][6][4] - The safety profile of epcoritamab in combination with rituximab was consistent with known safety profiles, with no new safety signals observed [4][6] Industry Context - Follicular lymphoma (FL) is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new cases annually in the U.S. [5] - Current treatment options for R/R FL often lead to declining response rates and shorter remission periods, with over 25% of patients potentially transforming to aggressive large-cell lymphoma [5][4] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [11][12] - The company is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, while pursuing additional international regulatory approvals [9][10]