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Genmab Announces Updated Results from Phase 2 EPCORE® NHL-6 Study Evaluating Epcoritamab Monotherapy in the Outpatient Setting in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Globenewswire· 2025-09-03 12:30
Media ReleaseCOPENHAGEN, Denmark; September 3, 2025 Trial demonstrated the feasibility of treating and monitoring adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in an outpatient setting Results showed that 92% of patients with R/R DLBCL received the first full dose of epcoritamab monotherapy in an outpatient settingAdverse event profile and efficacy were consistent with previously reported studies in R/R DLBCL patients Data also demonstrated 64.3% overall response rate w ...
Genmab to Participate in a Fireside Chat at the Morgan Stanley 23rd Annual Global Healthcare Conference
Globenewswire· 2025-08-26 13:31
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]
Genmab Receives FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S®) in Advanced Endometrial Cancer (EC)
Globenewswire· 2025-08-26 12:00
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]
Genmab/AbbVie Partnered Blood Cancer Combination Drug Cuts Risk Of Disease Progression By 79%
Benzinga· 2025-08-08 17:23
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]
Wall Street Analysts Believe Genmab (GMAB) Could Rally 33.8%: Here's is How to Trade
ZACKS· 2025-08-08 14:56
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]
Genmab(GMAB) - 2025 Q2 - Earnings Call Transcript
2025-08-07 17:02
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]
Genmab(GMAB) - 2025 Q2 - Earnings Call Transcript
2025-08-07 17:00
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]
Genmab(GMAB) - 2025 Q2 - Earnings Call Presentation
2025-08-07 16:00
Forward looking statement 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 products), ...
Genmab Announces Financial Results for the First Half of 2025
Globenewswire· 2025-08-07 15:08
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]
Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)
Globenewswire· 2025-08-07 14:30
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]