Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Event**: Guggenheim Emerging Outlook Biotech Summit 2026 - **Date**: February 11, 2026 Key Points on IgG4-RD and Obexelimab - **Pipeline Focus**: The primary focus is on obexelimab and its application in IgG4-related disease (IgG4-RD) [2][3] - **INDIGO Phase 3 Study Results**: - Reported a **56% risk reduction** in time to disease flare with a hazard ratio of **0.4** [3] - Approximately **75% of patients** were free from flares, indicating strong efficacy [3] - In the open-label extension, **92% of evaluable patients** remained flare-free at six months [4] - **Safety Profile**: - Serious adverse events were comparable to placebo, with no significant increase in infections [4][5] - The subcutaneous administration showed similar injection site reactions to placebo, enhancing its safety profile [5] Market Research Insights - **Market Research Study**: Conducted with **80 participants**, primarily rheumatologists and gastroenterologists [6] - **Prescribing Likelihood**: - **64%** of physicians indicated they would likely prescribe obexelimab [8] - Expected market share allocation: **47%** for obexelimab, with the remainder split between Uplizna and rituximab [8] - **Patient Population Insights**: - Physicians reported treating an average of **18 patients** per year with IgG4-RD [6] - The drug is seen as suitable for older patients or those with concurrent illnesses [9] Commercialization Strategy - **Market Opportunity**: Estimated market size for IgG4-RD treatment in the U.S. is between **$3-$4 billion**, with expectations for obexelimab to exceed **$1 billion** in sales [41][42] - **Patient Population**: Approximately **20,000 diagnosed patients** in the U.S. currently, with potential for growth through increased education and diagnosis [40] - **Launch Timeline**: - BLA filing expected in **Q2 2026** for the U.S. and in the second half of the year for Europe [56] - Initial launch will feature prefilled syringes, followed by an autoinjector within a year [56] Lupus Program Insights - **Sunstone Study**: - Results expected in **Q4 2026**, focusing on the **BICLA primary endpoint** [62] - Emphasis on strict screening criteria to ensure a pure patient population for accurate results [65] - **Biomarker Program**: A gene pattern identified in **30% of lupus patients** may indicate higher responsiveness to treatment [80] BTK Inhibitor Insights - **Orelibrutinib**: Positioned as a potent option for progressive MS, with ongoing trials to demonstrate its efficacy [90] - **Comparison with Competitors**: Fenebrutinib showed promising results compared to Ocrevus, indicating a competitive landscape for BTK inhibitors [88] Future Developments - **New Molecules**: - TYK2 and IL-17 oral molecules are set to enter clinical trials soon, with promising characteristics noted [95][97] - **Rapid Development**: The IL-17 molecule is expected to move quickly through clinical phases, with outcomes anticipated by the end of the year [97] Conclusion - Zenas BioPharma is positioned to capitalize on its robust pipeline, particularly with obexelimab for IgG4-RD, and is preparing for significant market entry and expansion in the coming years. The company is also actively pursuing additional indications, including lupus and progressive MS, with a focus on safety and efficacy in patient populations.

Core Insights - Amgen Inc. (NASDAQ:AMGN) is recognized as one of the 15 Best Wide Moat Dividend Stocks to invest in [1] - RBC Capital raised its price target for Amgen to $360 from $335, maintaining an Outperform rating, citing strong fourth-quarter performance driven by key drugs [2] - Amgen's fourth-quarter results exceeded Wall Street expectations, with shares experiencing a modest increase due to confidence in its weight-loss drug MariTide [3] Financial Performance - Quarterly revenue increased by 9% year-over-year to $9.9 billion, surpassing the consensus estimate of $9.5 billion [4] - Adjusted earnings per share were reported at $5.29, significantly above expectations of $4.73, despite ongoing pricing pressures [4] - Product sales volumes rose by 10%, while net prices declined by 4%, resulting in a 7% quarter-over-quarter growth [5] Future Outlook - Amgen anticipates adjusted earnings per share between $21.60 and $23.00 for 2026, with Wall Street estimating $22.09 [5] - The company forecasts full-year revenue of $37 billion to $38.4 billion, compared to analysts' expectations of $37.1 billion [5] - Amgen is actively conducting six Phase 3 trials for its weight-loss drug MariTide and plans to initiate additional studies in diabetes patients later this year [4] Company Strategy - Amgen focuses on developing, manufacturing, and delivering medicines for challenging diseases, with a strategy centered on high unmet medical needs [6] - The company's pipeline is designed to support growth beyond its established products, indicating a long-term commitment to innovation in the healthcare space [4][6]

Core Viewpoint - Amgen Inc. is experiencing strong performance and positive analyst outlook despite facing some challenges, with a maintained "Buy" rating and an increased price target from Cowen & Co. [1][5] Financial Performance - Amgen's fourth-quarter performance in 2025 exceeded expectations for both revenue and earnings per share, supporting a positive outlook from analysts [2][5] - The stock price is currently $338.59, reflecting a 1.80% decrease or $6.20 drop, with a market capitalization of approximately $182.32 billion [4] Growth Prospects - Key products like Repatha and Uplizna are expected to drive future growth, offsetting losses from Prolia and Xgeva [2][5] - Despite regulatory uncertainties and pipeline attrition, Amgen's long-term prospects remain strong, bolstered by positive data from Repatha and progress with MariTide [3][5] Market Activity - The stock has fluctuated between $338.59 and $349.50 today, with a yearly high of $353.25 and a low of $261.43 [4]

Core Insights - Amgen (AMGN) reported Q4 2025 adjusted earnings of $5.29 per share, exceeding the Zacks Consensus Estimate of $4.76 per share, with total revenues of $9.9 billion, a 9% year-over-year increase, surpassing the estimate of $9.5 billion [2][7] Revenue Performance - Total product revenues increased by 7% year-over-year to $9.37 billion, with a 10% rise in volume offset by a 4% negative impact from pricing [3] - Other revenues reached $499 million, up approximately 35% year-over-year [3] Key Drug Performance - Evenity sales were $599 million, a 39% increase year-over-year, surpassing the estimate of $565 million [4] - Repatha generated $870 million, up 44% year-over-year, exceeding the estimate of $812 million [4] - Prolia revenues were $1.05 billion, down 10% year-over-year but still beating the estimate of $975 million [5] - Xgeva revenues fell 20% year-over-year to $447 million, missing the estimate of $454 million [8] - Blincyto sales were $413 million, an 8% increase year-over-year, but missed the estimate of $435 million [9] - Otezla sales were $625 million, flat year-over-year, beating the estimate of $621 million [9] - Enbrel revenues declined 48% year-over-year to $532 million, missing the estimate of $636 million [10] - Tezspire recorded sales of $474 million, a 60% increase year-over-year, exceeding the estimate of $421 million [10] Cost and Margin Analysis - Adjusted operating margin decreased by 3.5 percentage points to 42.8% in Q4 [14] - Adjusted operating expenses rose 16% to $5.86 billion, with R&D expenses increasing by 26% to $2.13 billion [14] Full-Year Results - For the full year 2025, sales rose 10% to $36.8 billion, beating the estimate of $36.4 billion [15] - Adjusted earnings for 2025 were $21.84 per share, a 10% increase year-over-year, surpassing the estimate of $21.29 per share [15] 2026 Guidance - Amgen expects total revenues in the range of $37.0 billion to $38.4 billion for 2026, with adjusted earnings projected between $21.60 and $23.00 per share [17] - Adjusted operating margin is anticipated to be approximately 45% to 46% for 2026 [17] Pipeline Developments - Amgen is advancing MariTide, a GIPR/GLP-1 receptor, with six phase III obesity studies underway [19][20] - Enrollment has been completed in two pivotal studies for MariTide, with ongoing studies for cardiovascular disease and heart failure [21] - Plans to initiate phase III studies for MariTide in type II diabetes are set for later in 2026 [22]

Financial Data and Key Metrics Changes - Amgen delivered strong operational performance in 2025, achieving double-digit growth in revenues and earnings per share [4] - Non-GAAP operating margin was 46% for the full year, with non-GAAP R&D spending increasing 22% year-over-year to a record $7.2 billion [33][34] - Generated $8.1 billion in free cash flow for the full year, reflecting operational momentum and rigorous management of working capital [34] Business Line Data and Key Metrics Changes - Repatha sales grew 36% year-over-year, surpassing $3 billion, driven by increased urgency in treating patients [22] - Evenity sales increased 34% to $2.1 billion, with a 41% growth in the U.S. market [22] - Uplizna sales rose 73% year-over-year to $655 million, reflecting strong demand across all approved indications [25] - The rare disease portfolio grew 14% year-over-year to nearly $5.2 billion [25] - Innovative oncology portfolio grew 11% year-over-year, generating $8.7 billion in sales [30] Market Data and Key Metrics Changes - The U.S. market for Repatha is expected to see increased proactive management of LDL cholesterol due to new clinical guidelines [23] - Evenity leads the bone builder segment with over 60% market share [22] - Tezspire sales grew 52% year-over-year to nearly $1.5 billion, positioning it as a leading therapy for severe uncontrolled asthma [28] Company Strategy and Development Direction - Amgen is focusing on six key growth drivers for 2026: Repatha, Evenity, Tezspire, rare disease, innovative oncology, and biosimilars [35] - The company is committed to advancing innovation in areas of high unmet medical need while maintaining rigorous financial discipline [39] - Amgen plans to leverage AI across the value chain to enhance therapeutic discovery and development [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of MariTide and its differentiated treatment for obesity and related conditions [8] - The company anticipates 2026 to be a springboard year for future growth, despite expected declines from increased competition in certain products [35][36] - Management highlighted the importance of the VESALIUS-CV trial data in promoting Repatha for primary prevention [66] Other Important Information - Amgen retired $6 billion of debt in 2025, strengthening its balance sheet [34] - The company expects capital expenditures of about $2.6 billion in 2026 to support growth and pipeline launches [38] Q&A Session Summary Question: Insights on MariTide and obesity portfolio - Management highlighted the extensive development of MariTide across various indications and the potential for competing broadly in the obesity field [44][45] Question: Dazodalibep for primary Sjögren's syndrome - Management expressed confidence in the ongoing phase III studies and the compelling hypothesis behind the drug's mechanism [48][50] Question: Uplizna's market opportunity and usage - Management discussed the potential for increased awareness and diagnosis of IgG4-related disease, with Uplizna showing strong initial uptake [56][58] Question: Repatha's market strategy amid competition - Management emphasized the unique data package of Repatha and its established role in both primary and secondary prevention [66][69]

Financial Data and Key Metrics Changes - Amgen delivered strong operational performance in 2025, achieving double-digit growth in revenues and earnings per share [4] - Non-GAAP operating margin for the full year was 46%, with free cash flow generated at $8.1 billion [35][36] - Non-GAAP R&D spending increased 22% year-over-year to a record $7.2 billion, reflecting investments in late-stage pipeline opportunities [33][34] Business Line Data and Key Metrics Changes - Repatha sales grew 36% year-over-year, surpassing $3 billion, driven by increased urgency in treating patients [22] - Evenity sales increased 34% to $2.1 billion, with a 41% growth in the U.S. market [22] - Uplizna sales rose 73% year-over-year to $655 million, reflecting strong demand across approved indications [25][26] - The rare disease portfolio grew 14% year-over-year to nearly $5.2 billion [25] - Innovative oncology portfolio generated $8.7 billion in sales, with Imdelltra achieving $627 million in sales [31] Market Data and Key Metrics Changes - The biosimilars portfolio contributed over $3 billion in sales, with a 37% increase year-over-year [31] - Tezspire sales grew 52% year-over-year to nearly $1.5 billion, positioning it as a leading therapy for severe uncontrolled asthma [29] Company Strategy and Development Direction - Amgen is focusing on six key growth drivers for 2026: Repatha, Evenity, Tezspire, rare disease, innovative oncology, and biosimilars [36] - The company is committed to advancing innovation in areas of high unmet medical need while maintaining financial discipline [40] - Amgen plans to leverage AI across the value chain to enhance therapeutic discovery and development [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of MariTide and its differentiated treatment for obesity and related conditions [8] - The company anticipates continued strong performance in 2026, despite expected declines from increased competition in certain products [36][37] - Management highlighted the importance of updating clinical guidelines to encourage proactive LDL cholesterol management [23] Other Important Information - Amgen is engaged in ongoing discussions with the FDA regarding Tavneos, a treatment for ANCA-associated vasculitis [32] - The company has made significant investments in capital expenditures to support volume growth and prepare for pipeline product launches [36] Q&A Session All Questions and Answers Question: Insights on MariTide and obesity portfolio - Management emphasized the development of MariTide across various indications and the potential for competing broadly in the obesity field [44][45] Question: Dazodalibep for primary Sjögren's syndrome - Management expressed confidence in the ongoing phase 3 studies and the compelling hypothesis behind the drug's mechanism [48][49] Question: Uplizna's market opportunity and usage - Management discussed the potential for increased awareness and diagnosis of IgG4-related disease, as well as the positive initial uptake of Uplizna in generalized myasthenia gravis [51][56] Question: Repatha's market strategy amid competition - Management highlighted the unique data package supporting Repatha's use in both primary and secondary prevention, emphasizing its established trust among prescribers [64][66] Question: Tepezza and AMG 732 for TED - Management confirmed ongoing studies for Tepezza and its strong evidence base, while also discussing the competitive landscape [74][76]

Financial Data and Key Metrics Changes - Amgen delivered a 10% sales growth in 2025, with 14 products achieving over $1 billion in annual sales and 18 products reaching record sales [21][32] - Non-GAAP operating margin for the full year was 46%, with R&D spending increasing by 22% year-over-year to a record $7.2 billion [32][33] - Free cash flow generated for the full year was $8.1 billion, reflecting operational momentum and effective working capital management [33] Business Line Data and Key Metrics Changes - Repatha sales grew 36% year-over-year, surpassing $3 billion, driven by increased urgency in treating patients [21][22] - Evenity sales increased by 34% to $2.1 billion, with a 41% growth in the U.S. market [21][23] - Uplizna sales rose 73% year-over-year to $655 million, reflecting strong demand across all approved indications [24][25] - The rare disease portfolio grew 14% year-over-year to nearly $5.2 billion [24] - Tezspire sales grew 52% year-over-year to nearly $1.5 billion, positioning it as a leading therapy for severe uncontrolled asthma [28] Market Data and Key Metrics Changes - The U.S. market for Repatha is seeing improved patient access through broad formulary coverage and the launch of Amgen Now, a direct-to-patient program [22] - Evenity leads the bone builder segment with over 60% market share, with a significant opportunity remaining as nearly 90% of high-risk women remain untreated [23] - Uplizna is the most prescribed FDA-approved therapy for NMOSD in the U.S., supported by consistent new patient growth [25] Company Strategy and Development Direction - Amgen is focusing on six key growth drivers for 2026: Repatha, Evenity, Tezspire, rare disease, innovative oncology, and biosimilars [34][35] - The company is committed to advancing innovation in areas of high unmet medical need while maintaining rigorous financial discipline [38] - Amgen is leveraging AI across the value chain to enhance therapeutic discovery and development [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of MariTide and its differentiated treatment for obesity and related conditions [6][10] - The company anticipates 2026 total revenues in the range of $37.0 billion to $38.4 billion, with non-GAAP earnings per share between $21.60 and $23 [34][36] - Management acknowledged potential challenges from increased competition and pricing pressures but remains optimistic about the overall growth trajectory [36][38] Other Important Information - Amgen's innovative oncology portfolio grew 11% year-over-year, generating $8.7 billion in full-year sales [30] - The company is advancing multiple late-stage programs and has completed five key regulatory approvals in 2025 [9][19] Q&A Session All Questions and Answers Question: Insights on MariTide and obesity portfolio - Management highlighted the development of MariTide across various indications and expressed confidence in competing broadly in the obesity field [42][44] Question: Dazodalibep for primary Sjögren's syndrome - Management confirmed that both phase 3 studies are fully enrolled and expect completion later this year, expressing confidence in the drug's potential [47][49] Question: Uplizna's market opportunity and usage - Management discussed the potential for increased awareness and diagnosis of IgG4-related disease, noting strong initial uptake of Uplizna [51][56] Question: Confidence in Uplizna's phase 3 study in CIDP - Management expressed optimism about Uplizna's unique mechanism of action and the potential to help patients with CIDP [60][63] Question: Repatha's prescription sources and market evolution - Management indicated that approximately 40% of Repatha prescriptions come from primary care, with expectations for growth following the VASILIS data promotion [72][74] Question: Tepezza and AMG 732 for TED - Management confirmed ongoing studies for Tepezza and expressed confidence in its strong evidence base and market position [77][80]

Core Viewpoint - Amgen's drug Uplizna has received FDA approval for treating generalized myasthenia gravis (gMG) in adults with specific antibody profiles, marking a significant advancement in the treatment landscape for this rare disease [1][10]. Group 1: Drug Approval and Efficacy - Uplizna is the first CD19-targeted B-cell therapy approved for gMG, providing a twice-yearly dosing option, which is a notable advantage over existing therapies that require more frequent administration [2][10]. - The FDA's approval is based on data from the phase III MINT study, demonstrating strong efficacy in gMG patients [3][10]. - This approval represents the second for Uplizna in 2023 and its third overall in the U.S., following approvals for immunoglobulin G4-related disease and neuromyelitis optica spectrum disorder [4][10]. Group 2: Market Position and Competition - Uplizna enters a competitive market for gMG therapies, competing with argenx's Vyvgart/Vyvgart Hytrulo, J&J's Imaavy, and UCB's Rystiggo [6][10]. - While Uplizna, Vyvgart/Vyvgart Hytrulo, and Rystiggo are approved for adults, Imaavy has a broader age eligibility, being approved for patients aged 12 years and older [8]. Group 3: Financial Performance and Valuation - Amgen's shares have outperformed the industry year to date, indicating strong market performance [9][10]. - The company is currently trading at a price/earnings (P/E) ratio of 14.67, which is below the industry average of 16.59, suggesting a potential undervaluation [12]. - Earnings per share (EPS) estimates for 2025 and 2026 have increased in the past 30 days, reflecting positive market sentiment [13].

Core Insights - Amgen reported strong Q3 2025 earnings, with adjusted earnings of $5.64 per share, surpassing the Zacks Consensus Estimate of $5.00, and total revenues of $9.6 billion, exceeding the estimate of $8.9 billion, reflecting a 12% year-over-year increase [2][3] Financial Performance - Total product revenues increased by 12% year-over-year to $9.17 billion, driven by a 14% rise in volume, although partially offset by a 4% decline in pricing [3] - Other revenues rose by 19.3% year-over-year to $420 million, primarily due to higher royalty income [3] - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with operating expenses increasing by 18% to $5.25 billion [22] Key Product Performance - Prolia revenues reached $1.14 billion, up 9% year-over-year, significantly exceeding the Zacks Consensus Estimate of $911 million [6] - Evenity sales grew by 36% year-over-year to $541 million, surpassing the Zacks Consensus Estimate of $519 million [7] - Repatha generated revenues of $794 million, a 40% increase year-over-year, beating the Zacks Consensus Estimate of $720 million [7] - Biosimilar portfolio sales surged by 52% year-over-year to $775 million [5] Guidance and Outlook - Amgen raised its 2025 revenue and earnings outlook, expecting total revenues between $35.8 billion and $36.6 billion, and adjusted earnings per share in the range of $20.60 to $21.40 [24] - Adjusted operating margin is anticipated to be around 45%, with R&D expenses expected to grow at a mid-20s percentage rate year-over-year [25] Pipeline Developments - Enrollment has been completed in two phase III studies for MariTide, with approximately 5,000 adults enrolled [27] - Ongoing enrollment in two other phase III studies for atherosclerotic cardiovascular disease and heart failure [28]

Financial Data and Key Metrics Changes - The company reported a 10% revenue growth through the first nine months of the year, with product sales growth at 11% driven by a 14% volume growth [9][10] - In Q3, revenue growth was 12%, also driven by 14% volume growth, indicating strong momentum in the business [10] - Non-GAAP research and development expenses increased by 31% year over year in Q3, with a total of approximately $200 million spent on business development [12] Business Line Data and Key Metrics Changes - Repatha experienced a 30% year-over-year growth over the first nine months, with significant potential for future growth due to low penetration rates in the PCSK9 therapy market [13] - Evenity also grew by 30% year over year, holding a 60% market share in the U.S. bone builder market, with a large untapped patient population [14] - Tezspire achieved a remarkable 50% growth year over year, reaching $1 billion in sales in the U.S. for severe asthma [14] - The rare disease portfolio is annualizing at nearly $5 billion, growing 12% year over year, with Uplizna growing 50% year over year [15] - The innovative oncology segment grew by 11% year over year, driven by products like Blincyto and Imdeltra [15] Market Data and Key Metrics Changes - The company noted that the penetration rates for PCSK9 therapy remain low, indicating significant growth opportunities in the market [13] - The rare disease market is expanding, particularly for Uplizna, which has seen increased usage in IgG4-related diseases [15] Company Strategy and Development Direction - The company is focused on a volume-driven growth strategy, investing in innovation and science to enable longer, healthier lives [11] - Capital allocation priorities emphasize innovation, with a mid-20% allocation to R&D and a capital expenditure guide of $2.2 billion to $2.3 billion for the year [27][30] - The company is actively engaging with the government on pricing and access issues, aiming to enhance affordability for patients [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong momentum of the business and pipeline, highlighting the importance of innovation in the current environment [11][27] - The company anticipates increased competitive intensity in the biosimilar market, particularly for Prolia and Xgeva, but expects growth from its six major growth drivers [46][47] Other Important Information - The company is exploring opportunities in rare diseases and remains open to business development activities, including licensing and acquisitions [55] - The company has launched Amgen Now, a direct-to-consumer program aimed at increasing access to Repatha [32][40] Q&A Session Summary Question: What are the expectations for the impact of biosimilars on Prolia and Xgeva? - Management expects competitive intensity to increase, leading to revenue declines for Prolia and Xgeva, but anticipates growth from other product lines to offset this erosion [46][47] Question: How is the company navigating the pricing and access landscape? - The company has a history of successfully navigating pricing and access issues and remains confident in its ability to manage these challenges moving forward [36] Question: What is the company's strategy regarding rare diseases? - The company is pleased with its entry into the rare disease market and is open to further opportunities in this area, leveraging its existing capabilities [49][55]