Archer Aviation (NYSE:ACHR) FY Conference January 13, 2026 11:45 AM ET Company ParticipantsAdam Goldstein - CEOConference Call ParticipantsNone - AnalystChris Pierce - Senior AnalystChris PierceGood morning, everyone. Welcome to the 20th Annual Needham Growth Conference. My name is Chris Pierce with the Needham Research Team. It's my pleasure to welcome Adam Goldstein, CEO, Archer Aviation. Why don't you give us 30 seconds to on company history, why you decided to start the company, then we can move into so ...

Onto Innovation (NYSE:ONTO) FY Conference Summary Company Overview - **Company**: Onto Innovation (NYSE:ONTO) - **Event**: 28th Annual Needham Growth Conference - **Date**: January 13, 2026 Key Industry Insights - **AI Impact**: AI is a significant driver in the semiconductor industry, with NVIDIA projecting a 40% CAGR over the next few years, influencing demand and supply dynamics [6][7] - **Revenue Ties**: In 2025, 61% of Onto's revenue was derived from customers directly supporting the AI supply chain, indicating a strong correlation with AI growth [7] - **Market Outlook**: The outlook for 2026 is expected to be at least 10% stronger in the first half compared to the second half of 2025, reflecting improved customer sentiment [7] Product and Technology Developments - **AI Value Chain**: Onto is positioned in several areas of the AI value chain, including Gate-All-Around nodes, advanced packaging inspection, and 3D metrology [8][9] - **New Technologies**: The company is focusing on co-packaged optics and charge metrology, which are expected to contribute significantly to revenue growth, with an estimated additional opportunity of $1 billion [10][12] - **Dragonfly Platform**: The Dragonfly G3 has seen less decline than expected, with new applications being added. The upcoming Dragonfly G5 is expected to enhance resolution and throughput significantly [14][15] Financial Performance and Projections - **Operating Margin Improvement**: Onto aims for at least a 30% improvement in operating margin for 2026, driven by overseas manufacturing, new product value, and synergies from the SDI acquisition [18][19] - **Revenue Growth Drivers**: Growth is anticipated from advanced nodes and packaging, particularly in HBM and AI-related applications [21][30] Market Position and Competitive Landscape - **OSAT Engagement**: Onto is benefiting from the outsourcing of capabilities to OSATs, which are increasingly involved in AI packaging, enhancing Onto's market position [23][24] - **Lithography Business**: The JetStep system for panel-level packaging is gaining traction, with customers recognizing the importance of inline process control [25][27] Geopolitical Considerations - **China Exposure**: Onto's limited exposure to China provides some protection against geopolitical volatility, while the shift of manufacturing to Asia is expected to enhance engagement with Chinese customers [32][34] Customer Engagement and Value Proposition - **Value Quantification**: Onto emphasizes the importance of solving customer problems through reliable measurements and faster processing, which justifies their pricing strategy [36] - **Sustainable Advantage**: The company's understanding of customer challenges and its ability to address complex issues in packaging and inspection are seen as key differentiators in maintaining a competitive edge [37] Conclusion Onto Innovation is strategically positioned to leverage the growth in AI and advanced semiconductor technologies, with a strong focus on enhancing product capabilities and improving operational efficiencies. The company is optimistic about its growth trajectory in 2026, driven by innovative technologies and a robust market demand.

Protagonist Therapeutics (NasdaqGM:PTGX) FY Conference January 13, 2026 11:15 AM ET Company ParticipantsDinesh Patel - President and CEOArturo Molina - CMOSamuel Saks - CDAAsif Ali - EVP and CFOConference Call ParticipantsBrian Cheng - Senior Biotech AnalystNone - AnalystBrian ChengGood morning, everyone. Thanks for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng. I'm the Senior Biotech Analyst here at the firm. On stage, we have the CEO of Protagonist Therapeutics ...

Thermo Fisher Scientific FY Conference Summary Company Overview - **Company**: Thermo Fisher Scientific (NYSE:TMO) - **Revenue**: $44 billion - **Employees**: 120,000 - **R&D Investment**: Approximately $1 billion annually - **Market Share**: About 20% in the life sciences tools and diagnostics industry [4][7][20] Key Points from 2025 Performance - **Operational Success**: 2025 was characterized by excellent performance and effective navigation of market conditions, leading to significant advancements in growth strategy [3][12] - **End Markets**: The company serves four primary end markets: Pharma and biotech (56% of revenue), diagnostics and healthcare, academic and government, and industrial and applied [6][8] - **Market Trends**: Aging population and increasing demand for affordable healthcare are driving growth in the industry [8][9] - **Financial Growth**: Averaged 10% growth in top line over the last decade, with low double-digit growth in adjusted earnings per share and free cash flow [11] 2026 Outlook - **Market Context**: Positive sentiment in the biotech sector with improving funding and confidence in pharmaceutical investments [28] - **Growth Strategy**: Focus on executing growth strategy, gaining market share, and leveraging advanced AI capabilities for operational excellence [25][26] - **Revenue Growth Expectations**: Projected organic revenue growth of 3%-6% for 2026 and 2027, with expectations of 7%+ growth in 2028 and beyond [50][52] Capital Deployment and Acquisitions - **M&A Activity**: Active year with acquisitions including Solventum's purification and filtration business, a Sanofi manufacturing site, and a $9 billion acquisition of Clario [19][22] - **Strategic Fit**: Clario is expected to enhance Thermo Fisher's capabilities in clinical development and is projected to be accretive to earnings [48][49] Business Segment Performance - **Pharma Services**: High single-digit growth expected, benefiting from reshoring efforts and strong execution in clinical trials and drug product capabilities [34][36] - **Bioproduction**: Strong growth driven by leadership in media and single-use technologies, with the addition of Solventum expected to enhance the portfolio [37][38] - **Clinical Research**: Strong visibility and momentum in bookings, with a focus on accelerating drug development capabilities [40] - **Analytical Instruments**: Low single-digit organic growth, driven by innovation and demand from leading researchers despite a muted funding environment [41][43] Corporate Social Responsibility - **Environmental Initiatives**: Over 56% of global electricity sourced from renewable energy, on track to reach 80% by 2030 [24] - **Community Engagement**: Active in facilitating education and health equity initiatives globally [24] Conclusion - **Future Prospects**: Thermo Fisher is well-positioned for continued growth with a strong strategy, innovative product launches, and a commitment to operational excellence and corporate responsibility [26][29]

Teva Pharmaceutical Industries FY Conference Summary Company Overview - **Company**: Teva Pharmaceutical Industries (NYSE: TEVA) - **CEO**: Richard Francis - **Conference Date**: January 13, 2026 Core Industry and Company Strategy - Teva is transitioning from a leading global generics company to a leading biopharma company, a strategy initiated three years ago [2][3] - The "pivot to growth" strategy is based on four pillars: 1. Deliver on growth engines 2. Step up innovation 3. Create a generics powerhouse 4. Focus the business [3] Financial Performance - Teva has achieved 11 consecutive quarters of growth since early 2023, reversing a previous decline [5] - The company is experiencing a transformation in financials, with improvements in gross margin, free cash flow, EBITDA, and operating margin while reducing debt [6][30] - Revenue growth is primarily driven by the innovative business, which has doubled in the last three years [11] Innovative Products and Pipeline - Key innovative products include: - **Austedo**: Revenue expectations have increased from $1.4 billion to potentially $3 billion [9] - **Ajovy**: Targeting $1 billion in revenue with double-digit growth [9] - **Uzedy**: Projected to achieve $1.5-$2 billion in revenue [10] - Teva's pipeline includes several promising products: - **Duvakitug**: Entering phase 3 studies for ulcerative colitis (UC) and Crohn's disease (CD) [4] - **Anle138b**: Treatment for multiple system atrophy (MSA) with a significant unmet need [23] - **Anti-IL-15**: Targeting celiac disease and vitiligo, with multiple indications expected [19][25] Market Position and Competitive Landscape - Teva is positioning itself in high-value markets, including a $9 billion market for schizophrenia treatments [14] - The company aims for over $10 billion in peak sales across its innovative portfolio [13] - Teva's generics business is expected to grow at a low CAGR of 1%-2%, with a focus on biosimilars [26] Future Outlook - Teva anticipates a stable generics business while focusing on innovative growth, with a long-term vision extending over 20 years [5][31] - The company expects to maintain a 30% operating margin and continue growing EBITDA and free cash flow through 2027 [30] - Upcoming product launches include Olanzapine in 2026 and Daria in 2027, with a steady cadence of new products expected [36][38] Key Financial Metrics and Guidance - Revenue for 2026 is projected to be at the lower end of guidance due to the loss of $1.1 billion from generic Revlimid [29][41] - Despite this loss, Teva expects to grow EBITDA and operating margin, indicating a successful transformation of its portfolio [30] Conclusion - Teva is on a transformative journey towards becoming a leading biopharma company, with a strong focus on innovation and a robust pipeline of products that address significant unmet medical needs. The company is well-positioned for future growth, despite challenges in the generics market.

Alcon (NYSE:ALC) FY Conference January 13, 2026 11:15 AM ET Company ParticipantsDavid Endicott - CEODavid Adlington - Head of the European Medtech and Services ResearchNone - Video NarratorTim Stonesifer - SVP and CFOConference Call ParticipantsNone - AnalystDavid AdlingtonGood morning, everybody. Welcome to day two of the JPMorgan Conference. I'm David Adlington. I head up the European Medtech and Services Research Team in London for JP. It's my pleasure to introduce, we've got David and Tim on stage. Over ...

Summary of Ionis Pharmaceuticals FY Conference Call Company Overview - **Company**: Ionis Pharmaceuticals (NasdaqGS:IONS) - **CEO**: Brett Monia - **Conference Date**: January 13, 2026 Key Industry Insights - Ionis has transitioned from an R&D organization to a fully integrated commercial biotechnology company, achieving its first two independent commercial launches in 2025: **Tringulza** and **Donzera** [4][5] - The company has a robust pipeline with **11 medicines in phase 3 development**, indicating a strong future for product approvals and revenue growth [6] Core Products and Launches - **Tringulza**: Approved for familial chylomicronemia syndrome (FCS), generating **$105 million** in net U.S. product sales in 2025 [13] - **Donzera**: Approved for hereditary angioedema (HAE) prophylaxis, launched in September 2025, with positive early prescription trends [8][9] - **Olezarsen**: Positioned as a new standard of care for severe hypertriglyceridemia (SHTG), with a peak revenue potential now upgraded to **over $2 billion** [17][35] Clinical Achievements - Six positive phase 3 data readouts leading to four approved medicines: Tringulza, Donzera, Wainua, and Qalsody [6] - Olezarsen demonstrated a **72% reduction** in fasting triglycerides and an **85% reduction** in acute pancreatitis event rates at 12 months [15][16] - Zolexarsen for Alexander disease shows unprecedented disease-modifying impact, with plans for NDA submission and launch in the second half of 2026 [21][24] Financial Projections - Anticipated **$4 billion** in potential annual peak product revenue from wholly owned pipeline and **$2 billion** from partner medicines, totaling **over $6 billion** at peak [26] - Expected to achieve cash flow break-even by **2028** with sustained positive cash flow thereafter [26] Market Strategy and Launch Preparations - The launch strategy for Olezarsen in SHTG is based on strong physician enthusiasm and a high unmet need, with a field team of **200 individuals** already hired and trained [33][31] - Pricing strategy for Olezarsen is projected between **$10,000 to $20,000** in the U.S., with ongoing engagement with payers to ensure access [37][38] Risks and Challenges - New product launches inherently carry uncertainty, but the demand for Olezarsen is expected to be strong due to the inadequacy of current treatments for SHTG [36] - The company is preparing for potential challenges in achieving broad access and acceptance among healthcare providers [37] Future Outlook - Ionis is well-positioned for continued growth with a steady cadence of new medicines expected to reach the market, including Olezarsen and Zolexarsen in 2026 [24][25] - The company aims to leverage its strong pipeline and market presence to drive revenue growth and enhance shareholder value [28]

Cogent Biosciences FY Conference Summary Company Overview - **Company**: Cogent Biosciences (NasdaqGS:COGT) - **Lead Asset**: Bezuclastinib, a potent and selective KIT mutant inhibitor - **Focus**: Treatment of gastrointestinal stromal tumors (GIST) and systemic mastocytosis Key Points Industry and Market Opportunity - **Market Size**: The combined annual opportunity for non-advanced systemic mastocytosis and advanced systemic mastocytosis is approximately **$8 billion** [5] - **Competition**: Limited competition exists, primarily from Sanofi's Ayvakit for systemic mastocytosis and no competition in second-line GIST [5][10] - **Second-Line GIST Market**: Expected to be a **$4 billion** market with about **6,000 patients** annually becoming resistant to imatinib [10] Clinical Trials and Regulatory Submissions - **Pivotal Trials**: Three pivotal trials for bezuclastinib were positive in 2025, leading to NDA submissions: - **SUMMIT**: Non-advanced systemic mastocytosis (NDA submitted December 2025) - **PEAK**: GIST (NDA expected in April 2026) - **APEX**: Advanced systemic mastocytosis (NDA to follow PEAK) [2][3] - **Expected Launch**: Anticipated launch in the U.S. in the second half of 2026 for at least the non-advanced systemic mastocytosis indication [3] Financial Position - **Cash Reserves**: Approximately **$900 million** on the balance sheet, providing a cash runway into 2028 [4] - **Profitability Outlook**: Positioned to discuss profitability based on the timing of commercializations [4] Intellectual Property - **Patent Protection**: Strong intellectual property position with protection extending into the mid-2040s, including composition of matter and formulation patents [6][7] Clinical Efficacy - **GIST Trial Results**: - **Median Progression-Free Survival**: **16.5 months** - **Objective Response Rate**: Nearly **50%**, significantly higher than historical drugs [8][9] - **Symptomatic Improvement**: Notable improvements in overall symptoms and mast cell burden in systemic mastocytosis patients [11][12] Commercial Strategy - **Commercial Organization**: Building a team of approximately **100 employees** focused on access and patient community engagement [22][23] - **Expanded Access Program**: Ongoing program to provide access to bezuclastinib for patients, enhancing experience prior to full commercial launch [21] Future Developments - **Pipeline Expansion**: Plans to initiate trials for additional indications, including first-line GIST and combination therapies [18][19] - **New Assets**: Development of a selective JAK2 V617F inhibitor and a pan-KRAS inhibitor, with IND filings expected in 2026 [25][26] Pricing Strategy - **Benchmarking**: Pricing will be informed by existing KIT inhibitors, with current benchmarks around **$41,000 to $46,000** per month [39][40] International Expansion - **Partnerships**: Actively exploring partnerships for commercialization outside the U.S., particularly in Europe and other regions [41][42] Conclusion Cogent Biosciences is positioned for significant growth with its lead asset, bezuclastinib, targeting substantial market opportunities in rare diseases. The company is on track for multiple NDA submissions and a potential launch in 2026, backed by a strong financial position and a robust clinical pipeline.

Summary of Zimmer Biomet FY Conference Call (January 13, 2026) Company Overview - **Company**: Zimmer Biomet (NYSE: ZBH) - **Industry**: Medical Technology (MedTech), specifically Orthopedics Key Points and Arguments Company Transformation and Growth - Zimmer Biomet has undergone significant transformation over the past five years, shifting from a product-focused to a solutions-oriented approach, with an emphasis on cultural change [4][5] - The company reported a Compound Annual Growth Rate (CAGR) of 6.5% over the last five years, with revenue growth of 10% in 2021, 6.5% in 2022, and 7.5% in 2023 [5][6] - Adjusted earnings per share (EPS) for 2023 was $9.50, with a leverage of 200 basis points [5] U.S. Market Focus - The U.S. market accounts for 63% of Zimmer Biomet's revenue and over 51% of its debt [7] - The company aims to accelerate the transformation of its sales model in the U.S. to improve accountability and ownership [6][7] - A significant change in the U.S. sales model is planned, with a focus on specialization and direct sales [22] Innovation and Product Development - The company has shifted from launching eight products in 2018 to over 50 new products in the last three years, with 22 launched in 2025 alone [10][11] - Key innovations include the introduction of the first iodine-coated device aimed at preventing infections, set to launch in Japan in late 2025 [17][18] - The company is focusing on customer-centric innovation, addressing issues such as infection, efficiency, and patient outcomes [20][31] Market Dynamics - The orthopedic market is projected to grow at a rate of 4% to 4.25%, with Zimmer Biomet's performance tied to maintaining growth above this benchmark [13] - The company has seen consistent price positivity over the last seven quarters, indicating a favorable pricing environment [42] Financial Outlook - The company expects free cash flow to grow by 70% over the next five to six years, with 2026 anticipated to see free cash flow growth outpacing EPS growth [27][56] - Guidance for 2026 is tempered, aligning with the level of transformation expected, with projected organic growth of 3.5% to 4% [35][36] Strategic Investments - Zimmer Biomet has made three acquisitions in the past 14 months, including OrthoGrid and Paragon 28, to enhance its product offerings and market position [27][28] - The company plans to significantly increase its workforce dedicated to robotic solutions and ASCs (Ambulatory Surgery Centers) [24][25] Challenges and Execution - The company acknowledges the need for improved execution to ensure steady growth, addressing past inconsistencies in quarterly performance [20][21] - The transition to a specialized sales force is expected to create short-term disruptions but aims for mid- to long-term growth acceleration [46] Future Vision - By 2030, Zimmer Biomet aims to innovate beyond traditional implants, focusing on cartilage repair and leveraging data for predictive analytics in orthopedic care [32][33][34] Additional Important Insights - The company has improved employee engagement, making it to Forbes' World's Best Employers list for the first time [11] - Zimmer Biomet is committed to building a best-in-class company, focusing on operational excellence, innovation, and a strong company culture [30][34] This summary encapsulates the key points discussed during the conference call, highlighting Zimmer Biomet's strategic direction, market dynamics, and future aspirations in the orthopedic industry.

Edgewise Therapeutics Conference Call Summary Company Overview - **Company**: Edgewise Therapeutics (NasdaqGS:EWTX) - **Focus**: Biopharmaceutical company specializing in muscle diseases, particularly muscular dystrophy and cardiac conditions [2][4] Key Programs and Developments Muscular Dystrophy - **Sevasamtan**: Drug for muscular dystrophy, pivotal study enrollment completed in February 2025, data readout expected by the end of 2026 [2][4] - **Duchenne Program**: Positive data from studies showing decreased decline rates in patients previously treated with steroids and gene therapy [2][3] - **Becker Program**: Focus on a rare genetic disease with a unique mechanism of action targeting muscle damage, showing promising results in clinical trials [5][6][8] Cardiovascular Assets - **EDG-7500**: Cardiac sarcomere modulator with a strong safety profile, showing no changes in left ventricular ejection fraction (LVEF) [3][4][18] - **EDG-15400**: Second-generation molecule filed for IND, expected to enter HFpEF studies in the second half of 2026 [4][25] Financial Position - **Funding**: Successfully raised $200 million, with a total of $563 million in cash and no debt, providing a runway through 2028 [4][24] Market Potential - **Becker Disease Market**: Estimated at $5 billion, with 6,000 patients in the U.S. and 12,000 in major markets [14] - **Hypertrophic Cardiomyopathy (HCM) Market**: Potentially a $10 billion opportunity, targeting 165,000 symptomatic patients [23][24] Clinical Data and Efficacy - **Becker Program**: - 99% of patients in open-label extension remain on study, indicating durable response [8] - Statistically significant decreases in biomarkers of muscle damage [7][10] - NorthStar endpoint measures functional capacity, with a target of a 1-2 point change [8][11] - **EDG-7500**: - 89% of patients showed significant improvement in KCCQ scores [20] - No relationship between drug concentration and changes in ejection fraction, indicating a unique safety profile [22][23] Regulatory and Development Strategy - **FDA Engagement**: Plans to discuss trial designs for phase three studies in obstructive and non-obstructive HCM with the FDA [25][44] - **Commercial Strategy**: Building a commercial backbone for Sevasamtan while executing on HCM opportunities [49][50] Upcoming Milestones - **Data Readouts**: - Becker pivotal study results expected in December 2026 [25] - 12-week study data for EDG-7500 anticipated in the second quarter of 2026 [25] - **NDA Submissions**: Planned for 2027 following successful trial outcomes [24][25] Conclusion - Edgewise Therapeutics is positioned for significant growth with two differentiated assets in the muscular dystrophy and cardiovascular spaces, backed by strong financials and promising clinical data. The company is focused on executing its development and commercial strategies effectively to capitalize on the substantial market opportunities ahead [24][26]