Core Insights - BioInvent International AB is presenting new data on its ongoing trial of BI-1206 in combination with rituximab and Calquence for non-Hodgkin's lymphoma at the 2025 ASH Annual Meeting [1] Company Summary - BioInvent is focused on the discovery and development of novel immune-modulatory antibodies for cancer immunotherapy [1] - The trial data indicates that the triple combination regimen is safe and well-tolerated [1] - Encouraging efficacy data has been reported as part of the trial findings [1] Industry Context - The presentation will take place at the American Society of Hematology Annual Meeting, highlighting the significance of the findings within the hematology field [1]

Financial Data and Key Metrics Changes - Consolidated revenue for Q2 FY 2026 was INR 8,805 crore ($992 million), reflecting a year-over-year growth of 9.8% and a sequential growth of 3% [5][6] - EBITDA margin stood at 26.7%, a decrease of 174 basis points year-over-year but flat sequentially [8][9] - Profit after tax attributable to equity holders was INR 1,437 crore ($162 million), a growth of 14% year-over-year, remaining flat on a quarter-over-quarter basis [10][11] - Operating working capital as of September 30, 2025, was INR 13,331 crore ($1.5 billion), with a free cash flow of INR 1,046 crore ($118 million) generated during the quarter [11][12] Business Line Data and Key Metrics Changes - North America generic business generated revenues of $373 million, a decline of 16% year-over-year and 7% sequentially, impacted by price erosion in key products [19] - European business reported revenue of €135 million, a growth of 150% year-over-year and 3% quarter-over-quarter, driven by the acquired nicotine replacement therapy portfolio [20] - Emerging market business delivered revenue of INR 1,655 crore, reflecting a growth of 14% year-over-year and 18% sequentially, supported by new product launches [20] - India business reported revenues of INR 1,578 crore, achieving a double-digit growth of 13% year-over-year and 7% sequentially [21] Market Data and Key Metrics Changes - The U.S. generics faced pressure from product-specific price erosion and lower Revlimid sales, while overall growth was supported by the integration of the consumer healthcare business [6][14] - The company moved up one place to the ninth position in the India pharmaceutical market, outpacing market growth with a moving annual total growth of 9.4% compared to the industry growth of 7.8% [21] Company Strategy and Development Direction - The company aims to grow its base, scale its presence in consumer healthcare, and advance innovative therapies and biosimilars [13][14] - Focused R&D investments are being made in complex generics, APIs, and biosimilars, with a strategic collaboration to enhance innovation [8][22] - The company is actively pursuing strategic collaborations and acquisitions to support sustainable growth and enhance capabilities [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit growth and steady profitability, despite challenges in the U.S. generics market [13][14] - The effective tax rate for the quarter was lower at 22.2%, primarily due to a favorable jurisdictional mix [10] - Management remains committed to returning to a 25% EBITDA margin in the next two years, focusing on key products and operational efficiency [58] Other Important Information - The company has received positive opinions for its biosimilar candidates and is making progress on key pipeline products [15][16] - The company retained its MSCI ESG rating of A for the second consecutive year, indicating strong sustainability performance [17][18] Q&A Session Summary Question: Expectations for Revlimid sales in Q3 - Management indicated that Revlimid sales will continue in Q3 but at a lower level than in Q2, possibly tapering off towards Q4 [27] Question: U.S. product pipeline and meaningful launches - Management acknowledged the challenges in the U.S. product pipeline but highlighted that significant growth will come from biosimilars and complex generics [28] Question: Legal status of Semaglutide in India - Management confirmed ongoing litigation regarding Semaglutide patents in India, awaiting a court decision [38] Question: Abatacept filing and risk mitigation strategies - Management confirmed plans to submit the BLA for Abatacept by December 2025, with a CMO in place to mitigate risks [40][41] Question: Growth drivers in India and impact of GST - Management stated that GST was not a significant obstacle and attributed growth to strategic execution and brand acquisitions [47] Question: Future margin outlook - Management remains confident in returning to a 25% EBITDA margin, addressing the impact of Revlimid sales decline through strategic initiatives [58]

Core Insights - Genmab A/S announced promising results from the Phase 1b/2 EPCORE NHL-2 trial, demonstrating the efficacy of epcoritamab in combination with R-ICE for patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) [2][4][5] Trial Results - The overall response rate (ORR) was reported at 87 percent, with a complete response (CR) rate of 65 percent and a partial response (PR) rate of 23 percent [2][6] - At six months, 81 percent of responses were ongoing, 74 percent of patients were progression-free, and 100 percent of patients were alive [2][6] - Among patients who progressed within 12 months after first-line treatment, the ORR was 85 percent and the CR rate was 55 percent [4] - For patients who progressed after 12 months from first-line therapy, the ORR was 91 percent and the CR rate was 82 percent [4] Safety Profile - The safety profile indicated low-grade cytokine release syndrome (CRS) with no treatment discontinuations due to treatment-emergent adverse events (TEAEs) [3][5] - The most common TEAEs included neutropenia (74 percent), anemia (68 percent), and thrombocytopenia (68 percent) [3] - Serious infections were reported in 16 percent of patients, with no Grade 5 TEAEs observed [3] Industry Context - DLBCL accounts for approximately 25-30 percent of all non-Hodgkin's lymphoma cases globally, with around 25,000 new cases diagnosed annually in the U.S. [6][7] - The investigational treatment with epcoritamab aims to address significant unmet needs in the management of R/R DLBCL and other hematologic malignancies [5][12] Future Development - Genmab is collaborating with AbbVie to further develop epcoritamab as a core therapy for B-cell lymphomas, with ongoing trials evaluating its use in various treatment lines [5][12] - The EPCORE NHL-2 trial is part of a broader clinical program aimed at advancing epcoritamab both as monotherapy and in combination therapies [8][12]

Core Viewpoint - Genmab A/S plans to submit a supplemental Biologics License Application (sBLA) for subcutaneous epcoritamab in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma in the first half of 2025 [1][3] Company Announcement - The sBLA submission is based on positive topline results from the Phase 3 EPCORE FL-1 trial, which showed that epcoritamab plus rituximab (R) met one of its dual primary endpoints of overall response rate (ORR) with a p-value of less than 0.0001 [2][7] - The safety profile of the combination therapy was consistent with known safety profiles of the individual components, and no new safety signals were observed [2][3] About Follicular Lymphoma (FL) - Follicular lymphoma is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all cases, with approximately 15,000 new cases diagnosed annually in the U.S. [4] - It is considered incurable with current standard therapies, and patients often experience shorter remission periods with each relapse [4] About the EPCORE FL-1 Trial - The EPCORE FL-1 trial is a Phase 3 open-label interventional study evaluating the safety and efficacy of epcoritamab plus rituximab and lenalidomide versus rituximab alone in patients with relapsed/refractory follicular lymphoma [5] About Epcoritamab - Epcoritamab is an IgG1-bispecific antibody developed using Genmab's DuoBody technology, designed to target CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells [6][7] - It is currently approved by the FDA as a monotherapy for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy [3][7] Collaboration and Future Plans - Genmab is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, and both companies are pursuing additional international regulatory approvals for the investigational indication [8][9] - Genmab and AbbVie are also evaluating epcoritamab in various hematologic malignancies across multiple ongoing Phase 3 trials [9]