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.

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]

Core Insights - The third-quarter 2025 reporting cycle for the Medical sector is commencing, with major firms expected to release earnings results in the coming weeks, particularly in pharma/biotech and medical devices [1] - Johnson & Johnson has set a positive tone for the earnings season by exceeding estimates and raising its sales expectations for 2025 [1] - Roche has reported solid growth in the first nine months of 2025, driven by high demand for key drugs, leading to an upward revision of its earnings per share growth expectations for 2025 [2] Earnings Trends - As of October 22, 13.3% of Medical sector companies, representing 26.8% of the sector's market capitalization, have reported earnings, with 87.5% exceeding earnings estimates and the same percentage surpassing revenue expectations [3] - Year-over-year earnings increased by 7.4%, while revenues rose by 9.8%. However, third-quarter earnings for the Medical sector are projected to decrease by 4.3%, with sales expected to rise by 8.1% compared to the previous year [3] Company Performance Expectations - Eli Lilly is expected to report strong results driven by demand for GLP-1 drugs and other oncology and immunology products, with a consensus estimate of $16.01 billion in sales and $6.02 per share in earnings [7][8] - Merck is anticipated to see growth from its cancer drug Keytruda, with estimates of $17.06 billion in sales and $2.36 per share in earnings [12] - AbbVie is projected to benefit from sales of Rinvoq, Skyrizi, and newer drugs, with estimates of $15.59 billion in sales and $1.80 per share in earnings [13][14] - Bristol Myers is expected to report revenues influenced by growth portfolio sales, with estimates of $11.83 billion in sales and $1.51 per share in earnings [15][16] - Gilead Sciences is likely to see revenue support from its HIV therapies, with estimates of $7.46 billion in sales and $2.15 per share in earnings, although impacted by changes in Medicare Part D [19][20]

Core Insights - AbbVie has developed a significant oncology franchise, expanding from blood cancer drugs to include therapies for solid tumors, totaling five oncology products [1] - The oncology segment contributed over 11% to AbbVie's revenues in the first half of 2025, with a year-over-year growth of 5% [2] - Third-quarter 2025 oncology sales are estimated at $1.71 billion, reflecting nearly 2% growth year-over-year, despite declining sales of Imbruvica due to competition [3] AbbVie's Oncology Performance - AbbVie's oncology sales are projected to reach $1.71 billion in Q3 2025, with contributions from Venclexta, Epkinly, and Elahere, while Imbruvica continues to face challenges [7] - The recent approval of Emrelis for lung cancer is expected to provide modest revenue contributions in the upcoming quarter [3][7] Competitive Landscape - Major competitors in the oncology market include AstraZeneca, Merck, and Pfizer, with AstraZeneca's oncology sales accounting for nearly 43% of its total revenues, growing 11% in the first half of 2025 [5] - Merck's Keytruda, a PD-L1 inhibitor, represented over 48% of its total revenues in the first half of 2025, highlighting its significance in the oncology space [6] - Pfizer's oncology revenues grew 9% operationally in the first half of 2025, driven by several key drugs, now making up over 25% of its total revenues [6]

Core Viewpoint - AbbVie Inc. (NYSE:ABBV) is positioned as a high-growth mega-cap stock with a price target increase to $240 from $215, indicating a potential upside of nearly 10% following the resolution of litigation with generic drugmakers, allowing early market entry of generic Rinvoq [1] Group 1: Financial Performance and Market Position - AbbVie Inc. is expected to surpass market expectations due to the delayed entry of generic competition until 2037, four years after the 2033 expiration of the composition of matter patent [2] - The company has delivered a year-to-date return that outperforms the market by 14.31% [2] Group 2: Strategic Developments - AbbVie is expanding its neuroscience portfolio through the acquisition of Gilgamesh's bretisilocin and has improved overall guidance, reinforcing its position as a leading stock for the upcoming years [3] - The company is recognized for its consistent dividend track record, contributing to its reputation as a reliable investment [3] Group 3: Company Overview - AbbVie Inc. is a research-focused biopharmaceutical company based in Illinois, providing medicines and therapies internationally, with core offerings including Humira, Skyrizi, Rinvoq, Imbruvica, and Epkinly [4]

Core Insights - The article discusses Stephen's unique approach to analyzing healthcare and tech stocks using his proprietary "Dizzy Framework," which aims to mitigate common behavioral errors in investment decision-making [1] Group 1: Investment Framework - The "Dizzy Framework" is designed to counteract behavioral biases such as chasing market noise and adhering too rigidly to prior beliefs [1] - The framework emphasizes the importance of the quality and timing of information, promoting a patient and disciplined investment approach [1] - Stephen's analysis translates complex scientific and market dynamics into actionable investment theses [1] Group 2: Influences and Background - Stephen's background includes experience as a Registered Nurse (RN) and an MBA, which informs his investment analysis [1] - Influences on Stephen's investment philosophy include concepts from "Superforecasting" and "Fooled by Randomness," highlighting a probabilistic approach to predictions [1] Group 3: Personal Interests - In his personal time, Stephen enjoys family activities, managing a fantasy baseball team, and contemplating existential questions [1]

Group 1 - Genmab A/S is recognized as a global leader in antibody-based therapies, with significant commercial successes and advancements in late-stage clinical trials in 2025 [1][4] - The company markets therapies such as Tivdak for cervical cancer and Epkinly for lymphoma, while also developing a strong pipeline focused on high-need oncology indications [1][4] - A notable achievement for Genmab this year is the FDA's Breakthrough Therapy Designation for rinatabart sesutecan (Rina-S), which is aimed at treating recurrent or progressive endometrial cancer [2][4] Group 2 - Genmab's bispecific antibody epcoritamab shows promising results as an outpatient therapy for diffuse large B-cell lymphoma (DLBCL), with 92% of patients able to receive their first full dose in an outpatient setting [3] - The company is expanding the global reach of its marketed therapies, Tivdak and Epkinly, while utilizing its KYSO antibody platform to enhance its pipeline [4]

Core Insights - AbbVie has a strong immunology franchise with blockbuster drugs and has also developed a substantial oncology franchise with key products like Imbruvica and Venclexta [1] Oncology Franchise Development - AbbVie and Genmab's Epkinly was approved for relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma, while Emrelis was approved for non-squamous non-small cell lung cancer [2] - The acquisition of Immunogen added Elahere to AbbVie's oncology portfolio, contributing to double-digit revenue growth for Elahere and Epkinly in the first half of 2025 [2] - AbbVie's oncology segment generated $3.3 billion in revenue in the first half of 2025, a 4.2% increase year over year, driven by Venclexta and new drugs [3] Innovation in Oncology - AbbVie is enhancing its oncology portfolio with antibody-drug conjugates (ADCs), which are seen as a disruptive innovation in cancer treatment [4] - The company has two ADCs in its commercial portfolio and two additional next-generation ADCs in late-stage development, along with others in early-stage development [4] Pipeline and Growth Potential - A key candidate in AbbVie's oncology pipeline is etentamig/ABBV-383, targeting relapsed/refractory multiple myeloma [5] - Despite competitive pressure on Imbruvica, AbbVie's oncology business is well-positioned for growth in the coming years [5] Competitive Landscape - Major competitors in the oncology space include AstraZeneca, Merck, Bristol-Myers, and Pfizer, with AstraZeneca's oncology sales comprising around 43% of total revenues and growing 16% in the first half of 2025 [6] - Merck's Keytruda accounts for about 50% of its pharmaceutical sales, with a 6.6% sales increase to $15.1 billion in the first half of 2025 [7] - Pfizer's oncology revenues grew 9% in the first half of 2025, driven by various drugs, while AbbVie's oncology revenues rose 4.2% to $3.3 billion [8] Financial Performance and Valuation - AbbVie's stock has increased by 21.2% this year, outperforming the industry [10] - The company's shares trade at a price/earnings ratio of 15.54, higher than the industry average of 14.64 [13] - The Zacks Consensus Estimate for 2025 earnings has slightly decreased to $12.02 per share, while the estimate for 2026 has increased to $14.31 per share [16]

Core Insights - AbbVie's stock has increased by 11.5% in the past month due to strong second-quarter performance, beating earnings and sales estimates with earnings of $2.97 per share, a 12.1% year-over-year increase [1][2] Financial Performance - Revenues reached $15.42 billion, reflecting a 6.6% year-over-year increase, driven by strong sales of key drugs such as Rinvoq and Skyrizi, alongside contributions from newer drugs like Ubrelvy and Elahere [2][3] - AbbVie raised its revenue and EPS guidance for 2025, expecting adjusted EPS between $11.88-$12.08 and total revenues around $60.5 billion, up from previous estimates [3] Product Performance - AbbVie has successfully launched new immunology drugs, Skyrizi and Rinvoq, which are expected to replace declining sales from Humira, generating combined sales of $11.6 billion in the first half of 2025 [5][7] - Skyrizi and Rinvoq are projected to achieve combined sales exceeding $25 billion in 2025 and over $31 billion by 2027, with Skyrizi annualizing at nearly $18 billion and Rinvoq at over $8 billion [8][9] Oncology and Neuroscience Growth - The oncology segment generated $3.3 billion in the first half of 2025, a 4.2% year-over-year increase, supported by new drug launches and the addition of antibody-drug conjugates [11][13] - Sales in the neuroscience portfolio increased by 20.3% to nearly $5 billion, driven by products like Botox Therapeutic and newer migraine treatments [14] Acquisition Strategy - AbbVie has engaged in over 30 M&A transactions since early 2024, focusing on immunology, oncology, and neuroscience to enhance its early-stage pipeline [15][16] - Recent acquisitions include Capstan Therapeutics, adding a potential first-in-class CAR-T therapy to its immunology pipeline [16] Challenges and Market Dynamics - Humira's sales have declined over 50% in the first half of 2025 due to biosimilar erosion, with expectations of continued decline as more plans adopt exclusionary formularies [17] - Sales of Juvederm fillers have also decreased by 22.2% in the first half of 2025, impacted by macroeconomic challenges and weakened consumer sentiment [18] Stock Performance and Valuation - AbbVie's stock has gained 19.3% year-to-date, outperforming the industry and S&P 500 [19] - The stock trades at a price/earnings ratio of 15.31, higher than the industry average of 14.46, indicating a relatively high valuation compared to some peers [22] Future Outlook - AbbVie anticipates returning to mid-single-digit revenue growth in 2025, driven by the performance of Skyrizi and Rinvoq, with no significant loss of exclusivity events expected for the remainder of the decade [28][29]

Core Insights - Genmab A/S has released results from the Phase 3 EPCORE FL-1 trial, showing that subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) significantly improves outcomes for adult patients with relapsed or refractory follicular lymphoma [1][2] Study Results - The trial met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating a 79% reduction in the risk of disease progression or death [2] - Results will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will support global regulatory submissions [3] Regulatory Developments - The U.S. FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2, based on significant ORR and PFS improvements from interim analysis [4] - The FDA has set a target action date of November 30, 2025, for the sBLA [5] Market Performance - Genmab reported revenue of $1.64 billion for the first half of 2025, up from $1.38 billion year-over-year, with second-quarter sales of $925 million exceeding consensus estimates [6] - The 19% revenue increase was driven by higher royalties from collaborations and increased sales of Epkinly [7] - The company raised its fiscal year 2025 sales guidance to between $3.5 billion and $3.7 billion, surpassing consensus expectations [7]