Genmab(GMAB)2024-11-09 21:38Financial Data and Key Metrics - Total revenue for the first nine months of 2024 reached over DKK 15 billion, a 29% increase compared to the previous year [34] - Recurring revenues grew by 37%, driven by strong royalties from DARZALEX, Kesimpta, and other approved medicines, as well as strong performance from EPKINLY and TIVDAK [28][29] - Operating profit stood at over DKK 4.5 billion, up more than 27% year-over-year [34] - Net profit for the period was almost DKK 4 billion, reflecting strong underlying financial performance [36] Business Line Performance - EPKINLY reported 17% growth in Q3, with global net sales of 203 million [16] - TIVDAK demonstrated strong performance with 12 consecutive quarters of demand growth, achieving $32 million in sales [23] - EPKINLY and TIVDAK contributed 35% of Genmab's total revenue growth in the first nine months of 2024 [31] Market Performance - EPKINLY showed robust uptake in the U.S. and Japan, with strong field execution and positive responses from physicians and patients [17][22] - In Europe and the rest of the world, EPKINLY also saw strong growth through the partnership with AbbVie [22] - TIVDAK's demand growth was driven by the strength and breadth of accounts using the product, particularly in the gynecologic oncology space [23] Strategic Direction and Industry Competition - The company is focusing on maximizing the potential of its Phase 3 programs, including EPKINLY, Rina-S, and acasunlimab [12][32] - Genmab has terminated early-stage clinical programs (GEN1047, GEN3017, and GEN1056) and will not proceed with Phase 3 development for TIVDAK in second-line plus head and neck cancer [11] - The acquisition of ProfoundBio has enhanced Genmab's long-term growth potential, particularly in next-generation ADC platforms [27][43] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong performance of EPKINLY and TIVDAK, with consistent quarter-over-quarter growth [14][25] - The company expects continued strong growth for its own medicines, with around DKK 1.4 billion of growth from EPKINLY and TIVDAK in 2024 [38] - Genmab is committed to investing in Phase 3 trials for EPKINLY, Rina-S, and acasunlimab in 2025 [41] Other Important Information - The company plans to submit data for HexaBody-CD38 to J&J by the end of December 2024, with an opt-in decision expected by Q1 2025 [44] - Genmab will hold its annual R&D updates and data review event on December 11, 2024, which will be fully virtual [45] Q&A Session Summary Question: HexaBody-CD38 Data Disclosure - The top-line data for HexaBody-CD38 will be disclosed in the press release when J&J makes the opt-in decision, not at the time of data submission [47] Question: Rina-S and FR Alpha Expression - Rina-S has shown activity regardless of folate receptor alpha expression levels, with responses observed even in patients with expression below 25% [48] Question: TIVDAK Phase 3 Discontinuation - The decision to discontinue the Phase 3 trial for TIVDAK in head and neck cancer was based on strategic prioritization of the pipeline [52] Question: EPKINLY Commercial Potential - EPKINLY's major growth drivers are expected to be in the U.S. and Japan, with potential new approvals in follicular lymphoma (FL) and earlier lines of therapy [65] Question: 2025 Catalysts - Genmab expects further data on acasunlimab in lung cancer and updated data on Rina-S in ovarian carcinoma and other tumors in 2025 [69] Question: TIVDAK Cost Savings - The discontinuation of the TIVDAK Phase 3 trial will allow the company to reallocate resources to other Phase 3 programs, though specific cost savings were not detailed [70] Question: GEN1042 Next Steps - Genmab is collecting data on GEN1042 and will make a decision on next steps in the coming months [58] Question: HexaBody-CD38 Safety Profile - The company will not discuss HexaBody-CD38 safety data until J&J makes its opt-in decision [59] Question: Rina-S in Other Tumor Indications - Rina-S has shown activity in endometrial and non-small cell lung cancer, with potential for broader application across tumor types [84] Question: TIVDAK and KEYTRUDA Combination - The innovaTV 207 trial, exploring TIVDAK in combination with KEYTRUDA in frontline head and neck cancer, is ongoing [89] Question: Rina-S Trial Design - The Rina-S Phase 3 trial will not preselect patients based on folate receptor expression, though expression will be assessed in all patients [93] Question: Pipeline Reprioritization - Genmab has reprioritized its pipeline, discontinuing programs that did not meet internal differentiation criteria, while adding new programs like GEN1057 [100][101] Question: EPKINLY Patient Profile Evolution - EPKINLY is seeing broader patient populations, including those in earlier lines of therapy, with positive feedback from healthcare providers [102][103] Question: Autoimmune Disease Platform - Genmab is exploring innovative approaches to autoimmune diseases, including T-cell engagers and ADCs, though the focus remains on oncology for the near term [109][110]