Summary of Genmab FY Conference Call - March 11, 2026 Company Overview - **Company**: Genmab (NasdaqGS: GMAB) - **Key Focus**: Late-stage pipeline products including EPKINLY, Rina-S, and petosemtamab Key Points Industry and Pipeline Developments - **2026 Significance**: A pivotal year for Genmab with multiple important readouts expected from its late-stage pipeline [2][3] - **FDA Breakthrough Therapy Designation**: All three key products (EPKINLY, Rina-S, petosemtamab) have received this designation, enhancing their development prospects [2] EPKINLY - **Upcoming Readouts**: - Potential full approval for refractory DLBCL in the first half of 2026 - Frontline DLBCL readout expected later in 2026 [4][10] - **Confidence in Trials**: High confidence in upcoming trials despite previous monotherapy trial not meeting overall survival endpoints due to confounding factors [5][6] - **Primary Endpoint**: Progression-Free Survival (PFS) is the primary endpoint for the upcoming trials, which is aligned with regulatory expectations [8] - **Commercial Potential**: If successful, EPKINLY could significantly expand its market, potentially reaching an additional 90,000 to 100,000 patients in frontline settings [13] Rina-S - **Key Study**: RAINFOL-01 study for second-line plus ovarian cancer is set to report in the second half of 2026 [22] - **Efficacy Data**: Previous data showed an overall response rate (ORR) exceeding 50%, with confidence in replicating this in upcoming trials [23] - **Market Opportunity**: Combined patient population for ovarian and endometrial cancer is approximately 120,000, with a favorable split [24] Petosemtamab - **Expected Data**: Anticipated readouts from one or two head and neck cancer trials in the second half of 2026 [30] - **Efficacy Metrics**: Previous data indicated a 63% overall response rate when combined with pembrolizumab, significantly higher than pembrolizumab monotherapy [32] - **Future Plans**: Plans to initiate a phase 3 trial in locally advanced head and neck cancer by the end of 2026 [33] Financial Outlook - **Peak Year Sales Estimates**: - EPKINLY: $3 billion+ - Rina-S: $2 billion+ - Petosemtamab: Multi-billion range [41] - **Growth Prospects**: Strong growth anticipated even after the loss of DARZALEX royalties, supported by a robust pipeline and ongoing clinical development plans [42] Operational Strategy - **Market Approach**: Genmab is building its own distribution network in key markets (U.S., Japan, Germany) while considering partnerships in other regions [38] - **Operational Efficiency**: The company is confident in managing operational expenses while scaling its business [39] Competitive Landscape - **Differentiation**: Rina-S is positioned as a potential best-in-class asset with a comprehensive clinical profile and ongoing trials across multiple indications [27][29] Additional Insights - **Thought Leader Feedback**: Positive feedback from thought leaders regarding EPKINLY's PFS data and its potential in combination therapies [7][18] - **Regulatory Engagement**: Ongoing discussions with regulators to ensure alignment on trial endpoints and data expectations [8] This summary encapsulates the critical insights and projections discussed during the Genmab FY conference call, highlighting the company's strategic focus on its late-stage pipeline and the anticipated impact on its market position and financial growth.

Genmab Conference Call Summary Company Overview - **Company**: Genmab (NasdaqGS: GMAB) - **Year**: 2025 was highlighted as a strong year for Genmab, with significant financial growth and advancements in their late-stage pipeline, including three key programs: EPKINLY, Rina-S, and pivekimab [3][4] Financial Performance - **Revenue Growth**: Strong revenue growth was reported, alongside disciplined operational expenditure management, leading to profit flowing to the bottom line [3] - **Pipeline Progress**: The company has three late-stage programs with meaningful clinical data expected to support potential launches in 2027 [4] Key Programs and Commercial Opportunities EPKINLY - **Market Potential**: EPKINLY is viewed as a blockbuster medicine with a potential market opportunity exceeding $3 billion [6] - **Therapeutic Indications**: The program is expanding into earlier lines of therapy, particularly in second-line follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) [6][8] - **Clinical Data**: Positive performance in initial phases and robust uptake in community settings were noted [8][27] - **Regulatory Timeline**: Expected readouts for frontline DLBCL and second-line DLBCL trials in 2026, with potential regulatory submissions leading to a launch in 2027 [15][16] Rina-S - **Market Potential**: Rina-S has a peak opportunity estimated at over $2 billion, targeting multiple subsegments in gynecologic oncology [9][10] - **Clinical Trials**: Three ongoing phase 3 trials are in progress, with the first registrational readout expected in 2026 [9][10] - **Differentiation**: The program is positioned as potentially best-in-class with differentiated efficacy and safety profiles, allowing for longer durations of therapy [34][35] Pivekimab - **Market Potential**: Pivekimab is also projected to be a multi-billion dollar opportunity, with two ongoing phase 3 trials in head and neck cancer [11][12] - **Regulatory Timeline**: Expected readouts for these trials in 2026, with a potential launch in 2027 [11][12] Commercialization Strategy - **Market Readiness**: Genmab has been building its commercial infrastructure in the U.S., Japan, and Europe, preparing for the launches of Rina-S and pivekimab [18][22] - **Track Record**: The company has successfully launched TIVDAK and EPKINLY, which provides confidence for future launches [24][22] Competitive Landscape - **EPKINLY vs. Competitors**: EPKINLY is positioned to penetrate earlier lines of treatment and gain market share against other CD20 bispecific therapies [25][26] - **Rina-S Differentiation**: Rina-S is expected to outperform existing ADCs in ovarian cancer due to its efficacy across various folate receptor alpha expression levels [34][35] Milestones and Catalysts for 2026 - **Key Readouts**: Two phase 3 readouts for EPKINLY in DLBCL, and the first registrational data for Rina-S and pivekimab are anticipated in 2026, leading to potential launches in 2027 [52][54] - **Focus on Deleveraging**: The company aims to reduce its debt from the acquisition of Merus, targeting a gross leverage ratio of three times or below by the end of 2027 [50][51] Conclusion - Genmab is positioned for significant growth with multiple late-stage programs expected to yield positive clinical data and commercial opportunities in the coming years. The company’s strategic focus on commercialization and market readiness, alongside a strong pipeline, sets a promising outlook for future performance [4][12][54]

Summary of Genmab's Conference Call Company Overview - **Company**: Genmab - **Event**: 46th Annual TD Cowen Healthcare Conference - **Key Speakers**: Anthony Pagano (CFO and Executive VP), Yaron Werber (Biotech Team) Core Industry Insights - **Oncology Focus**: Genmab is heavily invested in oncology, with three late-stage programs: EPKINLY, Rina-S, and pidocentimab, all of which have received FDA Breakthrough Therapy designations [2][3] - **Revenue Growth**: The company is experiencing strong revenue growth, particularly from proprietary products like EPKINLY and TIVDAK, with an increasing percentage of recurring revenue [7][8] - **Future Projections**: Genmab anticipates continued revenue growth into 2026 and beyond, driven by the success of its late-stage programs and a robust internal pipeline [3][4] Financial Performance - **Revenue Profile**: The revenue quality has improved year-over-year, with a notable increase in the contribution from proprietary products [7] - **TIVDAK Performance**: TIVDAK is expected to remain flat in terms of growth, contributing approximately $20 million, while EPKINLY is the primary driver of revenue growth [9][12] - **EPKINLY Sales**: EPKINLY had global sales of DKK 468 million last year, with expectations for growth in 2026, particularly in the second-line follicular lymphoma segment [17][19] Product Pipeline and Launches - **Rina-S and pidocentimab**: Both are expected to have registrational readouts in the second half of 2026, with potential launches in 2027 or 2028 [21][22] - **Market Potential**: Rina-S has a peak sales potential of over $2 billion, while EPKINLY is projected to reach $3 billion [27][31] - **Regulatory Process**: The timeline for product launches will depend on the regulatory process following data readouts [22][23] Debt and Profitability - **Debt Management**: Genmab took on $5.5 billion of debt for the Mirati acquisition and aims to reduce gross leverage to below 3 times by the end of 2027 [39][40] - **Profitability Commitment**: The company is committed to maintaining significant profitability in 2026 and 2027, focusing on efficient investments and operational productivity [40][41] Royalty Contributions - **Royalty Business**: The royalty revenue is primarily driven by DARZALEX and Kesimpta, with expectations for growth in 2026 [58][59] - **Emerging Products**: Tecfidera is expected to contribute positively, although it remains a smaller product in the portfolio [58] Additional Insights - **Synergy Realization**: The acquisition of Mirati is not primarily synergy-driven, but Genmab is looking for productivity improvements across its business [55][56] - **Clinical Trial Dynamics**: The company is open to adjusting clinical trial parameters to enhance outcomes and timelines [24][25] This summary encapsulates the key points discussed during the conference call, highlighting Genmab's strategic focus on oncology, financial performance, product pipeline, and future growth prospects.

Company and Industry Summary Company: Zai Lab Key Financial Performance - 4Q total revenue increased by 17% year-over-year to $127.6 million, with FY25 revenue growing by 15% to $460.2 million [1] - Adjusted operating loss narrowed by 25% year-over-year, indicating improved operational efficiency [1] - Research and development (R&D) and sales expenses as a percentage of revenue decreased compared to 2024 [1] - Year-end cash reserves were robust, reaching $789.6 million [1] Clinical Development Highlights - Zoci: Global registration clinical trials for 2/3L SCLC are progressing rapidly, with three major data catalysts expected in 2026: intracranial efficacy for 2L+ SCLC, data for extra-pulmonary NEC, and 1L SCLC combination data (+PD-L1 ± chemotherapy) [1] - ZL-1503 (IL-13/IL-31Rα): Global Phase 1/1b trial is ongoing, with first human data expected in 2H26 [1] - ZL-6201 (LRRC15 ADC): Phase 1 trial has been initiated and is continuing to enroll participants [1] - ZL-1222 (PD-1/IL-12): Preclinical data updates are expected in 1H26, with IND application research anticipated to be completed within 2026 [1] - ZL-1311 (MUC17 TCE): IND application is expected to be completed by the end of 2026 [1] - Zai Lab is systematically laying out TCE and exploring additional immune cell factor directions beyond IL-12, with more details to be disclosed throughout the year [1] Company: Eiger BioPharmaceuticals Product Development and Market Strategy - Eiger is focused on increasing penetration and duration of therapy (DOT) for gMG and CIDP patients with its IV/SC formulations [2] - KarXT is set to be commercially launched in China in 2Q26, with preparations underway for 2027 insurance access [2] - Povetacicept and Elegrobart are expected to have critical data readouts for IgAN and TED in 1H26 [2] - Zoci (DLL3 ADC): Anticipated data for small lung intracranial and NEC in 1H26, with 1L SCLC registration clinical trials and new MOA combination clinical trials starting in 2026 [2] - ZL-1503 (IL-13/IL-31Rα): First human data is expected in 2026, focusing on pharmacokinetics, pharmacodynamics, and biomarker data in healthy subjects [2] - KarXT (schizophrenia) is set for launch; TIVDAK (cervical cancer) and TTFields (pancreatic cancer) are also being introduced in China [2]

Core Insights - Zai Lab is advancing its global oncology pipeline with a focus on zoci, a DLL3-targeting antibody-drug conjugate, which is in a global registrational Phase III study for small cell lung cancer (SCLC) and neuroendocrine carcinomas (NECs) [2][6][3] - The company anticipates an accelerated approval submission for zoci in 2027 and a first global approval in 2028, with promising clinical activity demonstrated in patients with brain metastases [1][6][3] - Zai Lab's commercially profitable business in China is funding its global R&D efforts, with fourth-quarter revenue increasing by 17% year-over-year to $127.6 million and a full-year revenue of $460 million [5][14] Pipeline Development - Zai Lab has initiated a global registrational Phase III study for zoci, targeting approximately 480 patients, with enrollment expected to reach 75% by the end of 2026 [2][6] - Additional pipeline developments include ZL-6201, which has received U.S. IND clearance and is entering a global Phase I study, and ZL-1222, which is progressing through IND-enabling studies [4][8] - The company is also advancing ZL-1503 for atopic dermatitis and plans to present initial data for NECs in the first half of 2026 [9][10] Financial Performance - Zai Lab reported a 19% improvement in operating loss to $229.4 million for the full year, with cash reserves of $790 million as it aims for corporate cash-flow breakeven [5][21] - R&D expenses decreased by 6% year-over-year, while SG&A expenses also saw a reduction, contributing to improved financial leverage [20][21] - The company expects a more measured growth profile in 2026, influenced by pricing dynamics and competition, while maintaining a long-term growth trajectory supported by guideline expansions [15][22] Strategic Focus - Zai Lab is focusing on building a globally innovative company, leveraging its China business for stability and funding [3] - The company is exploring first-line SCLC combination strategies and strengthening its oncology platform through targeted collaborations [13] - Zai Lab plans to initiate the commercial launch of KarXT in the second quarter of 2026, emphasizing disease awareness and clinical confidence [17]

Core Insights - The company reported a total revenue of $127.6 million for Q4 2025, representing a 17% year-over-year increase, and an annual total revenue of $460.2 million, up 15% year-over-year [1] - The net loss for Q4 2025 was approximately $50.4 million, narrowing by 38.29% year-over-year, while the annual net loss was about $175.5 million, a reduction of 31.73% year-over-year [1] - As of December 31, 2025, the company had cash and cash equivalents, short-term investments, and restricted cash totaling $789.6 million [1] Revenue and R&D Expenditure - Q4 2025 product revenue net was $127.1 million, a 17% increase from $108.5 million in Q4 2024, and the annual product revenue net was $457.2 million, up 15% from $397.6 million in 2024 [1] - R&D expenditure for Q4 2025 was $61.6 million, compared to $52.3 million in Q4 2024, while the total R&D expenditure for 2025 was $220.9 million, down from $234.5 million in 2024 [1] Strategic Developments - The reduction in net loss was attributed to product revenue growth outpacing operating expenses and a shift from foreign exchange losses to gains, although offset by decreased interest income [2] - The company plans to commercialize KarXT in the first half of 2026 and is actively developing targeted commercialization strategies and preparing for potential inclusion in the NRDL by 2027 [2] - Key data readouts for Povetacicept and elegrobart are expected in 2026, which may drive regional revenue growth [2] Leadership Insights - The CEO highlighted significant progress in the global innovation pipeline and steady advancement in commercialization efforts, emphasizing the importance of executing around key catalysts in 2026 [2] - The COO noted that KarXT is a crucial growth engine for the company, gaining recognition for its innovative mechanism and potential impact on schizophrenia patients, while also preparing for the approval of TIVDAK [2]

Core Insights - The company reported a total revenue of $127.6 million for Q4 2025, representing a 17% year-over-year increase, and an annual total revenue of $460.2 million, up 15% year-over-year [1] - The net loss for Q4 2025 was approximately $50.4 million, narrowing by 38.29% year-over-year, while the annual net loss was about $175.5 million, a reduction of 31.73% year-over-year [1] - As of December 31, 2025, the company had total cash, cash equivalents, short-term investments, and restricted cash amounting to $789.6 million [1] Revenue and R&D Expenditure - Q4 2025 product revenue netted $127.1 million, a 17% increase from $108.5 million in Q4 2024, and the annual product revenue netted $457.2 million, up 15% from $397.6 million in 2024 [1] - The R&D expenditure for Q4 2025 was $61.6 million, compared to $52.3 million in Q4 2024, while the annual R&D expenditure was $220.9 million, down from $234.5 million in 2024 [1] Strategic Developments - The reduction in net loss was attributed to product revenue growth outpacing operating expenses and a shift from foreign exchange losses to gains, although offset by decreased interest income [2] - The company plans to commercialize KarXT in the first half of 2026 and is actively developing targeted commercialization strategies and real-world evidence generation [2] - The CEO highlighted significant progress in the global innovation pipeline and emphasized the importance of executing around key catalysts in 2026 to prepare for future commercial growth [2]

Financial Data and Key Metrics Changes - Total revenue increased by 19% to $3.7 billion in 2025, driven by strong execution across the royalty portfolio and commercialized medicines [24][26] - Operating profit expanded to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales [25][29] - Sales of proprietary medicines totaled $632 million, up 54% year over year, accounting for approximately 28% of total revenue growth [16][24] Business Line Data and Key Metrics Changes - EPKINLY achieved $468 million in sales for the year, representing a 67% year-over-year increase, driven by its dual indication in diffuse large B-cell lymphoma and follicular lymphoma [17][19] - TIVDAK generated $164 million in sales, representing a 26% year-over-year increase, highlighting its continued market leadership in recurrent or metastatic cervical cancer [20][21] Market Data and Key Metrics Changes - EPKINLY closed 2025 with regulatory approvals in more than 65 countries, nearly all featuring the dual indication [17] - TIVDAK's launch in Germany showed strong, consistent uptake and positive physician feedback, indicating a successful entry into new markets [21][22] 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, with a focus on sustainable growth into the 2030s [5][6] - The acquisition of Merus is expected to enhance the late-stage portfolio with petosemtamab, providing multiple value-creating catalysts in 2026 and beyond [8][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in executing key data readouts in 2026 and subsequent high-impact launches in 2027, emphasizing a disciplined approach to capital allocation and investment prioritization [30][29] - The company anticipates continued momentum in EPKINLY and its royalty portfolio, with a revenue growth guidance of 14% for 2026 [26][29] Other Important Information - The company has five combined breakthrough therapy designations for its late-stage programs, indicating significant long-term growth potential [9] - Management highlighted the importance of maximizing first-mover advantage in second-line follicular lymphoma in the U.S. and anticipated approvals in Europe and Japan [19][20] Q&A Session Summary Question: Next steps for EPKINLY following EPCORE DLBCL-1 study results - Management confirmed that the 05 study showed positive progression-free survival but missed overall survival, with ongoing discussions with regulatory agencies regarding the data set [33][34] Question: Update on outpatient data for EPKINLY - Management indicated that the outpatient study is crucial for modifying the label and facilitating administration in the community [41][44] Question: Expectations for Rina-S pivotal phase II readout - Management stated that the study is designed to support accelerated approval based on overall response rate and duration of response [50][51] Question: Expectations for EPCORE DLBCL-4 trial outcomes - Management expressed optimism that the trial will lead to registration in second-line and third-line settings, differentiating it from other studies [55][56] Question: Thoughts on pembro approval in PROC and implications for Rina-S - Management acknowledged the approval as a good option for patients but believes Rina-S can be more transformative for a broader population [61] Question: EPKINLY frontline DLBCL trial expectations - Management emphasized that the primary endpoint is progression-free survival, with expectations for EPKINLY to be transformative in combination with R-CHOP [66][68]

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]

Corbus Pharmaceuticals Holdings (NasdaqCM:CRBP) Update Summary Company Overview - **Company**: Corbus Pharmaceuticals Holdings - **Focus**: Development of CRB-701, an antibody-drug conjugate (ADC) targeting head and neck cancer, cervical cancer, and bladder cancer Key Industry Insights - **Market Opportunity**: There is a significant unmet need in the head and neck cancer market, particularly for patients who have undergone multiple lines of therapy and have limited treatment options available [15][41] - **Patient Demographics**: The median number of prior lines of therapy for patients in the study was three, indicating a heavily pretreated population [6][17] Core Points and Arguments - **Differentiated Product Profile**: CRB-701 has a unique pharmacokinetic profile with a drug-antibody ratio of two, allowing for higher total antibody delivery and a more favorable safety profile compared to other ADCs [5][6] - **Dosing Regimen**: The drug can be administered every three weeks, which is appreciated by physicians and may improve patient compliance [4][23] - **Safety and Efficacy**: The overall burden of treatment-emerging adverse events is low, with a grade 3 adverse event level of around 35%, significantly lower than competitors like TIVDAK, which reported 59% [7][32] - **Patient Case Studies**: Anecdotal evidence from patient case studies demonstrates the potential for CRB-701 to provide significant clinical benefits, including long-term survival and improved quality of life [12][13][14] Additional Important Insights - **Recruitment Success**: The trial's design was patient-friendly, allowing for faster recruitment by including patients with a broader range of health statuses and prior treatments [20][21] - **Biomarker Considerations**: There is ongoing discussion about the role of biomarkers, such as nectin-4 levels, in predicting treatment response, with current data suggesting that expression levels may not be a reliable predictor [55][60] - **Future Directions**: The immediate clinical need for CRB-701 is identified as a monotherapy option for patients in the second or third line of treatment, particularly those who have progressed after immunotherapy and platinum-based therapies [41][42] Conclusion Corbus Pharmaceuticals is positioned to address a significant unmet need in the treatment of head and neck cancer with CRB-701, which offers a differentiated safety and efficacy profile compared to existing therapies. The company is focused on leveraging its unique product characteristics and patient-friendly trial design to enhance recruitment and ultimately improve patient outcomes in a challenging treatment landscape.