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Genmab(GMAB) - 2024 Q1 - Quarterly Report
2024-05-02 15:08
Exhibit 99.1 Genmab Announces Financial Results for the First Quarter of 2024 May 2, 2024 Copenhagen, Denmark; Interim Report for the First Quarter Ended March 31, 2024 Highlights "The acceptance for Priority Review by the U.S. FDA of the sBLAs for EPKINLY and Tivdak that we received in the first quarter are important events that support our commitment to continue to deliver innovative treatment options that have the potential to profoundly impact the lives of patients. These regulatory acceptances for prio ...
TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer
Newsfilter· 2024-04-29 22:40
Company Announcement Full approval based on global Phase 3 study demonstrating overall survival benefit of TIVDAK compared to chemotherapyTIVDAK is the first antibody-drug conjugate in this patient population to have positive overall survival data COPENHAGEN, Denmark; April 30, 2024 – Genmab A/S (NASDAQ:GMAB) and Pfizer Inc. (NYSE:PFE) announced today the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the tr ...
Biotech giant Genmab to acquire Seattle company ProfoundBio in $1.8B deal
GeekWire· 2024-04-03 15:28
ProfoundBio, a Seattle-based biotech firm developing drugs to treat ovarian and endometrial cancers, will be acquired by publicly traded Danish drugmaker Genmab in a $1.8 billion all-cash deal expected to close in the first half of this year, the companies announced Wednesday. ProfoundBio, which is headquartered in Seattle and has a R&D center in China, specializes in antibody-drug conjugates (ADCs), agents that recognize a molecular target via an antibody and deliver a toxin or other compound to cells. It ...
Genmab Buys ProfoundBio for $1.8B to Boost Oncology Portfolio
Investopedia· 2024-04-03 13:20
KEY TAKEAWAYSDanish drugmaker Genmab said Wednesday that it is buying privately held U.S. biotech firm ProfoundBio for $1.8 billion in cash as it expands its pipeline of cancer treatments.The takeover will give Genmab access to a portfolio of next-generation antibody-drug conjugates, or ADCs, including one to treat ovarian cancer.Genmab's planned purchase comes as a spate of drug giants expand their focus on boosting their portfolios of drugs to treat cancer. Danish drugmaker Genmab A/S (GMAB) said Wednesda ...
Genmab(GMAB) - 2023 Q4 - Earnings Call Transcript
2024-02-14 21:17
Genmab A/S (GMAB) Q4 2023 Results Conference Call February 14, 2024 12:00 PM ET Company Participants Jan van de Winkel - Co-Founder, President and Chief Executive Officer Anthony Mancini - Executive Vice President & COO Anthony Pagano - Executive Vice President & CFO Tahi Ahmadi Genmab - Executive VP, Chief Medical Officer Conference Call Participants James Gordon - JPMorgan Chase & Co Kaveri Pohlman - BTIG Peter Verdult - Citigroup Inc Sachin Jain - BofA Securities Jonathan Chang - Leerink Paul Jeng - Gugg ...
Genmab(GMAB) - 2023 Q4 - Annual Report
2024-02-14 18:49
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ◻ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ⌧ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ◻ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 1 ...
Genmab(GMAB) - 2023 Q4 - Annual Report
2024-02-14 17:30
Organizational Growth and Infrastructure - Genmab reached a milestone of 2,000 team members internationally in 2023, reflecting significant organizational growth[6] - Genmab expanded its global infrastructure with the opening of a new headquarters in Copenhagen and the expansion of its R&D Center in Utrecht, housing 500 team members[24] - Genmab has over 2,200 team members across international locations, supporting its growing organization and presence[53] - The Accelerator facility in Utrecht, opened in 2023, supports Genmab's continued growth trajectory with state-of-the-art R&D capabilities[57] - Genmab's U.S. facility, opened in 2020, includes precision medicine laboratories and meets LEED Gold certification for sustainable design[59] - Genmab's Japan office in Roppongi uses renewable energy and fosters an environmentally friendly, collaborative environment[60] Financial Performance and Projections - Genmab's revenue for 2023 was DKK 16,474 million, with operating expenses of DKK 10,927 million, of which 70% was invested in R&D[28] - Genmab's market capitalization at the end of 2023 was DKK 142 billion[28] - Genmab's liquidity and capital resources included marketable securities of DKK 13,268 million and cash and cash equivalents of DKK 13,268 million[28] - Revenue for 2023 was DKK 16.474 billion, with a projected 2024 revenue range of DKK 18.7 – 20.5 billion, representing a 14% to 19% growth[36][38] - DARZALEX royalties are expected to contribute DKK 12.6 – 13.3 billion in 2024, based on estimated DARZALEX net sales of USD 10.9 – 11.5 billion[40] - Net product sales and collaboration revenue are projected to grow significantly, with a 2024 guidance of DKK 1.7 – 2.2 billion, up from DKK 728 million in 2023[36][39] - Operating expenses are anticipated to increase to DKK 12.4 – 13.4 billion in 2024, up from DKK 10.9 billion in 2023, to support portfolio advancement and future product launches[42] - Operating profit for 2024 is expected to range between DKK 4.6 – 7.1 billion, compared to DKK 5.3 billion in 2023[43] - Genmab's 2024 revenue growth is driven by higher royalties, net product sales, and collaboration revenue, particularly from DARZALEX, Kesimpta, Tivdak, and EPKINLY[39] - The 2024 financial guidance assumes a USD/DKK exchange rate of 6.8 and excludes potential impacts from new agreements that could materially affect results[45] - Risks to the 2024 outlook include variations in development activities, net sales of key products, and currency exchange rate fluctuations[45][46] Product Development and Approvals - Genmab's second product, Epcoritamab, was approved as EPKINLY in the U.S. and Japan and TEPKINLY in Europe, marking the first time Genmab led commercial efforts in these regions[15] - Genmab anticipates additional approvals for Epcoritamab in 2024 and the start of multiple Phase 3 trials to expand into earlier lines of therapy[15] - Tivdak (tisotumab vedotin) showed positive results in cervical cancer and head and neck cancer studies, leading to discussions with regulatory authorities for further development[16] - Acasunlimab (GEN1046) demonstrated promise in second-line non-small cell lung cancer, with plans to present data at a medical conference in 2024[18] - Genmab's partnership with Janssen resulted in three approved medicines: RYBREVANT, TECVAYLI, and TALVEY, the latter approved in both the U.S. and Europe in 2023[20] - The company plans to initiate Phase 3 trials for EPKINLY and Tivdak, aiming to expand their labels and clinical development programs[49] - EPKINLY/TEPKINLY (epcoritamab) received regulatory approvals in the U.S., Europe, and Japan for treating relapsed/refractory DLBCL and LBCL after two or more lines of systemic therapy[79][89] - The European Medicines Agency (EMA) validated a Type II variation application for epcoritamab as monotherapy for relapsed/refractory FL after two or more lines of systemic therapy, supported by data from the EPCORE NHL-1 trial[91][92] - Genmab and AbbVie have three ongoing Phase 3 trials for epcoritamab, including trials in relapsed/refractory DLBCL and newly diagnosed DLBCL[91] - The U.S. FDA granted Breakthrough Therapy Designation (BTD) for epcoritamab for the treatment of relapsed/refractory FL[94] - EPKINLY was added to the NCCN Clinical Practice Guidelines for B-cell Lymphomas as a preferred regimen for third-line and subsequent therapy for DLBCL patients[94] - Tivdak (tisotumab vedotin-tftv) is the first and only U.S. FDA approved ADC for recurrent or metastatic cervical cancer, with a 50:50 profit split between Genmab and Pfizer in the U.S., Japan, Europe, and China[103][104] - The innovaTV 301 Phase 3 trial for Tivdak met its primary endpoint of improved overall survival (OS) in September 2023, supporting global regulatory applications[103][107] - The NCCN updated their Clinical Practice Guidelines in Oncology for Cervical Cancer, moving Tivdak to "Preferred Regimens" for second-line or subsequent therapy in recurrent or metastatic cervical cancer[110] Pipeline and Clinical Trials - Genmab's proprietary pipeline includes nine antibodies in clinical development, with at least 50% responsibility for development[77] - Acasunlimab (GEN1046/BNT311) is a bispecific antibody co-developed by Genmab and BioNTech, with ongoing Phase 2 trials in NSCLC and advanced endometrial cancer[112][113] - GEN1042 (BNT312) is a bispecific antibody targeting CD40 and 4-1BB, with multiple clinical trials in solid tumors ongoing[114][116] - GEN3014, a HexaBody-based investigational medicine, is in a Phase 1/2 clinical trial for hematologic malignancies, comparing it to daratumumab in CD38 monoclonal antibody-naïve relapsed or refractory multiple myeloma patients[118][119] - GEN1047, a bispecific antibody targeting CD3 and B7H4, is in Phase 1/2 clinical trial (NCT05180474) for malignant solid tumors, currently in the dose-expansion phase[121] - GEN1053 (HexaBody-CD27, BNT313) is co-developed by Genmab and BioNTech, with a Phase 1/2 clinical trial ongoing in solid tumors[123] - GEN1056 (BNT322) is in a first-in-human Phase 1 clinical trial (NCT05586321) for advanced solid tumors, co-developed with BioNTech[124] - GEN3017, a bispecific antibody targeting CD3 and CD30, is in Phase 1/2 clinical trial for relapsed or refractory classical Hodgkin lymphoma and NHL[125] - Genmab submitted an IND for GEN1059/BNT314 (DuoBody-EpCAMx4-1BB) in August, with preclinical disclosure at the ESMO Congress in October[132] Collaborations and Partnerships - Genmab's partnership with Janssen resulted in three approved medicines: RYBREVANT, TECVAYLI, and TALVEY, the latter approved in both the U.S. and Europe in 2023[20] - Genmab and AbbVie share commercialization responsibilities for epcoritamab in the U.S. and Japan, with Genmab receiving tiered royalties between 22% and 26% on global sales outside these territories[89] - Genmab and BioNTech share all costs and future potential profits for Acasunlimab and GEN1042 on a 50:50 basis[112][114] - Genmab's collaboration with AbbVie includes potential milestone payments and tiered royalties between 22% and 26% on net sales for epcoritamab outside the U.S. and Japan, with up to USD 2.0 billion in potential milestone payments for four next-generation antibody candidates[165] - Genmab's collaboration with BioNTech includes two bispecific antibody products in clinical development, with an IND submitted for an additional bispecific program in August 2023[167] - Genmab's collaboration with Janssen has resulted in three approved DuoBody-based medicines, with Genmab eligible for milestone payments and royalties on net sales[169] - Genmab's collaboration with Novo Nordisk includes potential milestones and mid-single digit royalties on sales of Mim8, should it receive regulatory approval[170] Technology Platforms - Genmab's DuoBody technology platform has generated four approved medicines, with potential applications in cancer, autoimmune, infectious, cardiovascular, and central nervous system diseases[160] - Genmab's HexaBody technology platform is designed to increase antibody potency, with two HexaBody-based investigational medicines currently in clinical development[173] - Genmab's HexaBody technology platform has been combined with the DuoBody technology platform to create the DuoHexaBody technology platform, enhancing antibody therapeutics for a broad range of applications[173] - Genmab's HexaBody technology platform has been used to generate antibodies with enhanced complement-mediated killing, leading to potent, cytotoxic antibodies[173] - DuoHexaBody technology platform combines dual-targeting and enhanced potency, creating bispecific antibodies with target-mediated enhanced hexamerization[174] - HexElect technology platform combines dual-targeting with enhanced selectivity and potency, maximizing efficacy while minimizing toxicity[176] Royalties and Revenue Streams - DARZALEX and DARZALEX FASPRO, developed by Janssen, generated royalties for Genmab, with indications including multiple myeloma and light-chain amyloidosis[83] - Kesimpta (ofatumumab), developed by Novartis, generated royalties for Genmab for the treatment of relapsing multiple sclerosis[84] - TEPEZZA (teprotumumab-trbw), developed by Amgen, generated royalties for Genmab for the treatment of thyroid eye disease[84] - DARZALEX (daratumumab) achieved 2023 net sales of USD 9,744 million, with royalties between 12% and 20% for Genmab[136] - Kesimpta (ofatumumab) is approved in the U.S., EU, and Japan for RMS treatment, with Genmab receiving a 10% royalty on net sales[137][138] - TEPEZZA (teprotumumab-trbw) generates mid-single digit royalties for Genmab on net sales, following Amgen's acquisition of Horizon[139] - RYBREVANT (amivantamab) is the first approved medicine using Genmab's DuoBody technology, with royalties between 8% and 10% on net sales[143][144] - TECVAYLI (teclistamab) received U.S. FDA approval in October 2022 for relapsed or refractory multiple myeloma, developed under Genmab's DuoBody collaboration with Janssen[147] - TECVAYLI is the second therapy created using Genmab's proprietary DuoBody technology platform to receive regulatory approval, with Genmab eligible for mid-single digit royalties on net sales[148] - TALVEY (talquetamab) is the fourth therapy created using Genmab's DuoBody technology platform to receive regulatory approval, with Genmab eligible for mid-single digit royalties on net sales[153] Environmental and Social Responsibility - Genmab supports TCFD recommendations for climate-related financial disclosures and aims to reduce environmental footprint[180] - Genmab's Scope 1, 2, and 3 emissions totaled 147,721 tons CO2e in 2022, serving as a baseline for climate targets[189] - Genmab aims for a 42% reduction in Scope 1 and 2 emissions by 2030 compared to 2021 baseline and to reduce Scope 3 emissions through supplier engagement[189] - Genmab conducted scenario analysis on climate-related risks and opportunities across 1.5–2°C and 4°C warming scenarios[186][187] - Genmab's CSR strategy focuses on science-driven health innovations, employee well-being, ethics, and environmental sustainability[181][185] - Genmab's CSR governance is led by the Board of Directors, with oversight from the Nominating and Corporate Governance Committee and Audit and Finance Committee[183] - Total Scope 1 emissions in 2023 were 317 tCO2e, an increase from 283 tCO2e in 2022[192] - Total Scope 2 emissions in 2023 were 238 tCO2e, up from 111 tCO2e in 2022[192] - Electricity consumption in 2023 was 3,293 MWh, compared to 3,127 MWh in 2022[192] - Share of renewables in electricity consumption decreased to 76.8% in 2023 from 94.0% in 2022[192] - Genmab prioritizes the health, well-being, safety, and development of its employees as a cornerstone of its success[195] - Genmab engages with patient advocacy organizations to support patients and collaborate on educational events[196] - Genmab is committed to contributing to the sustainability of the communities where its employees live and work[197] Market and Disease Statistics - DLBCL accounts for approximately 30% of all NHL cases, with an estimated 30,400 U.S. cases in 2022[96] - FL accounts for 20% to 30% of all NHL cases and represents 10% to 20% of all lymphomas in the Western world[99] - In 2023, an estimated 13,960 new cases of invasive cervical cancer will be diagnosed in the U.S., with 4,310 adults expected to die from the disease[111] Strategic Initiatives and Future Plans - Genmab's strategy includes investing in its people and culture, scaling the organization, and broadening its antibody product and technology portfolio[48] - Genmab collaborates with pharma, biotech, and academia to develop next-generation antibody therapeutics[194] - Genmab has a diverse shareholder base, essential for its growth as a biotech innovation powerhouse[199] - Genmab focuses on attracting and retaining qualified employees to develop transformative treatments for cancer and other serious diseases[200]
Genmab(GMAB) - 2023 Q3 - Earnings Call Transcript
2023-11-07 19:32
Genmab A/S (GMAB) Q3 2023 Earnings Conference Call November 7, 2023 12:00 PM ET Company Participants Jan van de Winkel - Co-Founder, President & Chief Executive Officer Anthony Pagano - Executive Vice President & Chief Financial Officer Judith Klimovsky - Chief Development Officer Anthony Mancini - Chief Operating Officer Tahi Ahmadi - Chief Medical Officer Conference Call Participants Vikram Purohit - Morgan Stanley Jonathan Chang - Leerink Paul Jeng - Guggenheim Partners Etzer Darout - BMO Sachin Jain - B ...
Genmab(GMAB) - 2023 Q3 - Earnings Call Presentation
2023-11-07 17:33
Quarter End Results Forward-looking 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 ...
Genmab(GMAB) - 2023 Q3 - Quarterly Report
2023-11-07 16:12
Exhibit 99.1 Genmab Announces Financial Results for the First Nine Months of 2023 November 7, 2023 Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2023 Highlights "With regulatory approvals in Japan and Europe, EPKINLY/TEPKINLY is the first Genmab- owned medicine to become available to patients outside of the United States. In addition to being an important milestone for Genmab, these approvals mark an important milestone for patients in these territories who are in need of ...