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Genmab to Participate in a Fireside Chat at the Citi Global Healthcare Conference in Miami
Globenewswire· 2025-11-24 12:00
Core Points - Genmab A/S announced that its Chief Financial Officer, Anthony Pagano, will participate in a fireside chat at the Citi Global Healthcare Conference on December 4, 2025 [1] - A webcast of the event will be available on Genmab's website [1] Company Overview - Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics [2] - The company has over 25 years of experience in developing next-generation antibody technology platforms, including bispecific T-cell engagers and antibody-drug conjugates [2] - Genmab aims to transform the lives of patients with cancer and serious diseases by 2030 with its proprietary antibody medicines [2] Company History and Presence - Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with a presence in North America, Europe, and Asia Pacific [3]
Genmab A/S (GMAB) Presents at Jefferies London Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-11-22 12:23
Core Viewpoint - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues, particularly when ad-blockers are in use [1] Group 1 - The article suggests that users may face restrictions if they have ad-blockers enabled, indicating a need for adjustments in browser settings to ensure smooth access [1]
Genmab (NasdaqGS:GMAB) 2025 Conference Transcript
2025-11-19 13:02
Summary of Genmab's Conference Call Company Overview - **Company**: Genmab - **Event**: Jefferies London Healthcare Conference - **Key Speakers**: CEO Jan van de Winkel, CFO Anthony Pagano Key Focus Areas Late-Stage Programs - Genmab is focusing on late-stage programs including: - **Epkinly** - **Rinatabart sesutecan** - **Acasunlimab** - **Patu Centamab** (acquisition of Merus) [2][3][4] Patu Centamab - **Description**: A bispecific antibody targeting EGFR, showing significant tumor shrinkage in clinical trials. - **Clinical Data**: - In frontline head and neck cancer, a **63% overall response rate** when combined with Pembrolizumab, tripling the benchmark response [9]. - In second-line settings, a **36% overall response rate** with impressive median progression-free survival of **11.4 months** [9]. - **Safety Profile**: New dosing schedules have improved infusion-related reactions, and a subcutaneous version is in development to further mitigate these issues [11]. - **Potential**: Beyond head and neck cancer, Patu Centamab is expected to have applications in other EGFR-positive tumors [6][12]. Epkinly - **Launch Performance**: Launched in May 2023, with potential to become a **$3 billion-plus global brand**. - **Recent Developments**: Positive data in second-line follicular lymphoma, with a significant hazard ratio of **0.21**, indicating a **79% risk reduction** for disease progression [21]. - **Commercial Strategy**: Focus on subcutaneous delivery and maintaining a balance of safety and efficacy [20]. Rinatabart sesutecan - **Characteristics**: Combines a good antibody with a hydrophilic linker, allowing for multiple toxin attachments without compromising pharmacodynamics [23]. - **Clinical Data**: Expected to have a clean safety profile with no ocular toxicity or interstitial lung disease observed [24]. - **Market Potential**: Peak year sales guidance upgraded to **$2 billion**, with a launch expected in **2027** [28]. Acasunlimab - **Clinical Development**: Ongoing studies in second-line plus lung cancer, with follow-up data expected to bolster confidence in its efficacy [30]. - **Sales Guidance**: Projected peak sales of around **$1 billion**, reflecting a conservative approach due to competition in the lung cancer market [31]. Financial Considerations - **Investment Strategy**: 2026 is expected to be an investment year, focusing on late-stage pipeline and commercialization capabilities [14][15]. - **EBITDA Growth**: Anticipated meaningful growth in EBITDA by **2027**, with projections of over **$1 billion** in sales for Patu Centamab by **2029** [16][17]. Other Considerations - **Pipeline Focus**: Genmab remains primarily focused on oncology, with over **90%** of activities in this area, while maintaining some preclinical work in immunology and inflammation [34][35]. - **Future Developments**: Plans to advance two bispecifics and one ADC from the organic pipeline by the end of the year [36]. Conclusion - Genmab is strategically positioned with a robust late-stage pipeline and a clear focus on maximizing the potential of its key assets, particularly Patu Centamab, Epkinly, and Rinatabart sesutecan, while managing investments and operational efficiencies to drive future growth.
Genmab Announces Pricing of Private Offering of Senior Secured Notes and Senior Unsecured Notes and Completion of Syndication of New Senior Secured Term Loan Facility
Globenewswire· 2025-11-18 21:01
Core Points - Genmab A/S announced the pricing of $1.5 billion of 6.250% senior secured notes due 2032 and $1.0 billion of 7.250% senior unsecured notes due 2033, with an issue price of 100.000% [1] - The company has completed the syndication of a new $2.0 billion senior secured term loan "B" facility, in addition to existing credit facilities [2] - The net proceeds from the notes offering will be used to fund the acquisition of Merus N.V. and related expenses [3] Financing Details - The total financing includes $1.5 billion in secured notes and $1.0 billion in unsecured notes, alongside a $2.0 billion senior secured term loan "B" facility [1][2] - The secured notes will be backed by segregated accounts prior to the acquisition closing, and will later be secured by a first priority interest in certain assets of Genmab and its subsidiaries [4] - The indentures governing the notes will include covenants that restrict Genmab and its subsidiaries from incurring additional debt and other financial activities [5] Regulatory Information - The notes have not been registered under the Securities Act and are available only to qualified institutional buyers or non-U.S. persons [6] - The offering does not constitute an offer to sell or a solicitation of an offer to purchase any securities [7]
Genmab Announces EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide Approved by the U.S. Food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma
Globenewswire· 2025-11-18 16:30
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]
Genmab Provides Certain Information Disclosed in Connection with Proposed Private Offering of Senior Secured Notes and Senior Unsecured Notes
Globenewswire· 2025-11-10 15:51
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]
Genmab Announces Proposed Private Offering of Senior Secured Notes and Senior Unsecured Notes and Syndication of New Senior Secured Term Loan Facility
Globenewswire· 2025-11-10 12:12
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]
Genmab(GMAB) - 2025 Q3 - Earnings Call Transcript
2025-11-06 18:00
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]
Genmab(GMAB) - 2025 Q3 - Earnings Call Presentation
2025-11-06 17:00
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]
Genmab(GMAB) - 2025 Q3 - Quarterly Report
2025-11-06 16:11
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].