Coya Therapeutics (NasdaqCM:COYA) FY Conference December 02, 2025 08:45 AM ET Company ParticipantsArun Swaminathan - CEOConference Call ParticipantsCory Kasimov - Senior Biotech AnalystCory KasimovYeah, there we go. Good morning, everybody. My name is Cory Kasimov, one of the senior biotech analysts here at Evercore ISI. It's my pleasure to host our next discussion with Coya Therapeutics and the company's CEO, Arun Swaminathan. I hope I got that right. Arun, thanks very much for being here today. Really app ...

Summary of Air Products and Chemicals Conference Call Company Overview - **Company**: Air Products and Chemicals (NYSE: APD) - **Industry**: Industrial gases - **History**: 85 years of operation, active in approximately 50 countries - **Core Business**: Supplies industrial gases, equipment, and expertise to various sectors including refining, chemicals, metals, electronics, manufacturing, medical, and food - **Leadership**: CEO Eduardo Menezes and CFO Melissa Schaeffer, with Menezes having over 30 years of industry experience since joining in February 2025 [1][2] Key Projects Louisiana Project - **Scale**: Producing 750 million cubic feet of hydrogen daily, with 80% intended for ammonia production and 20% for hydrogen pipeline [4] - **Status**: Seeking agreements with ammonia producers to manage the ammonia facility; project is larger than similar projects in the Gulf Coast [5] - **Timeline**: Expecting to provide updates within two weeks regarding project direction [5] Neom Project - **Construction Progress**: On track for completion by 2027; plans to sell ammonia as an interim product until green hydrogen offtake begins later in the decade [8] - **Market Strategy**: Focus on arbitrage between power and capital costs between Saudi Arabia and Europe; potential to produce competitive green hydrogen in Europe [9][10] - **Regulatory Environment**: EU regulations on renewable fuel usage are evolving, with expectations for implementation by 2030 [11] Financial Outlook - **CapEx**: Projected at $4 billion for 2026, including investments in Louisiana and Neom; cash flow neutrality expected by 2026 [15][16] - **Deconsolidation**: Neom's debt will be removed from financials in 2027, improving balance sheet metrics [17] - **Cost Savings**: Aiming for $100 million in additional cost savings through efficiency measures [38] Market Conditions - **U.S. Market**: Low growth environment; challenges include tariffs and labor issues affecting new investments [31][32] - **Asia Market**: Strong growth in Korea and Taiwan driven by electronics; China remains competitive but with limited growth [33] - **Europe Market**: Affected by product influx from China; local manufacturers facing challenges due to regulatory complexities [34] Helium Market - **Current Status**: Helium market is long, affecting pricing; Air Products has a significant exposure due to its historical position as a leading supplier [37] Operational Efficiency - **AI Integration**: Air Products is exploring AI applications for operational efficiency, with initiatives in power management and vendor engagement [43][44][45] Conclusion - **Strategic Focus**: Air Products is refocusing on core industrial gas strengths while managing large-scale projects like Neom and Louisiana; the company aims to balance growth with operational efficiency amidst challenging market conditions [29][30]

Summary of REGENXBIO FY Conference Call Company Overview - **Company**: REGENXBIO (NasdaqGS: RGNX) - **Industry**: Gene Therapy Key Milestones and Programs - **Hunter Program**: PDUFA date set for February 2026, marking a significant milestone after nine years of development [2][9] - **Duchenne Program**: Top-line data expected in early Q2 2026, with enrollment completed in October 2025 [2][9] - **Subretinal Program for Wet AMD**: Top-line data anticipated late next year, with the market size projected to exceed $10 billion by launch [3][28] Manufacturing Capabilities - REGENXBIO has invested significantly in its manufacturing facility in Rockville, designed to meet modern gene therapy standards [7][26] - The facility has been inspected with no observations, which is considered a de-risking factor for the company [10][26] Commercialization Strategy - Partnership with NS Pharma for commercialization of the Hunter program, allowing REGENXBIO to focus on manufacturing and supply chain control [12][26] - The company has a long-standing relationship with the MPS Society, aiding in patient identification for the ultra-rare disease [13] Market Position and Differentiation - REGENXBIO's one-time gene therapy approach is expected to significantly reduce the burden of care compared to traditional treatments, such as enzyme replacement therapy [14] - The company aims to be the first gene therapy to enter the Enzyme Replacement Therapy (ERT) market, which is a notable milestone [15] Data and Expectations - Upcoming data readouts are critical, with a focus on safety and efficacy in younger patient populations for the Duchenne program [20][21] - The company anticipates a successful BLA filing in mid-2026, contingent on positive data outcomes [24] Financial Position - Current cash balance is projected to sustain operations into early 2027, with additional non-dilutive financing expected [43] - Potential monetization of a Priority Review Voucher (PRV) associated with the Hunter program's approval could provide further financial support [43] Investor Insights - REGENXBIO has emphasized its long-term commitment to gene therapy, leveraging its extensive experience and knowledge in the field [45][46] - The company aims to maintain transparency with investors regarding data and safety as it transitions into a commercial entity [46] Conclusion - REGENXBIO is positioned for a pivotal year in 2026 with multiple key milestones, including PDUFA dates and data readouts that could significantly impact its market presence and stock performance [44]

Inovio Pharmaceuticals FY Conference Summary Company Overview - **Company**: Inovio Pharmaceuticals (NasdaqCM: INO) - **Focus**: Development of innovative therapies for HPV-related diseases, particularly recurrent respiratory papillomatosis (RRP) and other cancers. Key Points Industry and Disease Context - **Recurrent Respiratory Papillomatosis (RRP)**: - A rare disease caused by HPV types 6 and 11, leading to wart-like growths in the airways, affecting speech, swallowing, and breathing [3][4] - Current treatment involves repeated surgeries, which can lead to permanent vocal cord damage after multiple procedures [4] Product Development - **INO-3107**: - A DNA medicine delivered via a proprietary CELLECTRA device using electroporation, avoiding lipid nanoparticles or viral vectors [7][8] - Mechanism: Produces antigens targeting HPV E6 and E7 oncoproteins, generating cytotoxic T cells to destroy infected cells [9] - Clinical data shows a significant reduction in surgeries: - Median surgeries decreased from four to one in the first year post-treatment [11] - 28% of patients required no surgeries in the first year, increasing to 50% in the second year [11] Regulatory Status - **BLA Submission**: - Rolling submission completed on October 30, 2025, with expectations for acceptance feedback by year-end and a proposed PDUFA date in mid-2026 [13] Competitive Landscape - **Comparison with Precigen's PRGN-2012**: - PRGN-2012 is a gorilla-based adenoviral product requiring additional surgeries during treatment, contrasting with INO-3107's patient-centric approach [15][18] - Precigen's pricing is $115,000 per dose, totaling $460,000 for a four-dose regimen, excluding additional surgical costs [20] Market Potential - **Epidemiology**: - Estimated 14,000 active RRP cases in the U.S., with new cases at approximately 1.8 per 100,000 annually [22] - Inovio anticipates capturing a significant market share despite Precigen's entry, projecting single-digit penetration for Precigen in the first year [22] Future Development - **Pipeline Candidates**: - INO-3112 targeting HPV-positive head and neck cancers, with plans for a phase three trial [28] - INO-5401 for glioblastoma, also moving towards a randomized control trial [29] In Vivo Protein Production Technology - **Innovative Approach**: - Inovio's technology allows for the endogenous production of proteins, demonstrated with monoclonal antibodies against SARS-CoV-2, showing sustained production over 72 weeks [33] - Focus on long-term therapeutic protein production, with ongoing preclinical candidates [34][35] Financial Position - **Cash Reserves**: - Ended Q3 with approximately $51 million, with additional funds raising total cash to around $70 million, potentially reaching $100 million with warrant exercises [36][37] - Funds expected to support operations through the PDUFA date and facilitate launch preparations [37] Conclusion - Inovio Pharmaceuticals is positioned for a significant market entry with INO-3107, backed by promising clinical data and a robust pipeline, while navigating a competitive landscape with a focus on patient-centric treatment options [38]

Summary of Guardant Health FY Conference Call Company Overview - **Company**: Guardant Health (NasdaqGS:GH) - **Industry**: Life Sciences, Tools, and Diagnostics Key Financial Targets - **Revenue Target**: $2.2 billion by 2028, with a potential aspiration of $5 billion [2][4] - **Oncology Revenue**: Expected to be $1.4 billion by 2028, accounting for over 60% of total revenue [4][6] - **Biopharma Revenue**: Forecasted to grow from $200 million to $300 million by 2028 [5] - **Screening Revenue**: Projected to reach $500 million by 2028, representing approximately 25% of total revenue [6] Product Performance and Growth - **Guardant360**: Continues to grow at approximately 30% year-over-year, driven by increased orders per oncologist and new SMART apps [7][10] - **Reveal**: Fastest-growing oncology product, with potential for new indications and therapy monitoring applications [5][12] - **Shield**: Expected to contribute significantly to revenue, with a target of $500 million by 2028 [6] Market Dynamics - **Oncology Market**: Guardant360 has penetrated the oncology market well, with over 10,000 oncologists ordering the test annually [7] - **Liquid Biopsy**: The company believes that centralized lab business will remain dominant due to the complexity of services offered compared to hospital labs [24] Regulatory and Reimbursement Strategies - **ADLT Submission for Reveal**: Ongoing process with potential upside if approved, targeting an ASP of $1,000 by 2028 [14][16] - **Medicare Reimbursement**: Critical for achieving ASP targets and driving revenue growth [16] Operational Efficiency and Cost Management - **Cost of Goods Sold (COGS)**: Targeting $200 per test for Shield, with current costs below $500 [17][29] - **Gross Margin Targets**: Expecting gross margins of 65-70% across the product portfolio by 2028 [29][30] Sales and Marketing Strategy - **Sales Force Expansion**: Currently over 250 sales representatives, with plans for continued ramp-up [35] - **Partnership with Quest**: Aims to leverage Quest's extensive network to enhance market penetration [35] Future Outlook and Strategic Initiatives - **Breakeven Target**: Committed to achieving breakeven by the end of 2027, with no changes to the plan despite recent funding [26][27] - **M&A Opportunities**: Focused on acquiring technologies that enhance product offerings, with a preference for smaller deals [39][40] Clinical Trials and Product Development - **SERENA-6 Protocol**: Anticipated to be a significant catalyst for product adoption and market expansion [37][38] Conclusion - Guardant Health is positioned for strong growth in the oncology diagnostics market, with a clear strategy for revenue generation, operational efficiency, and market expansion through innovative products and strategic partnerships. The company remains focused on achieving its financial targets while navigating regulatory landscapes and enhancing its product offerings.

PROG (NYSE:PRG) M&A Announcement December 02, 2025 08:30 AM ET Company ParticipantsBobby Griffin - Managing DirectorBrian Garner - CFOJohn Baugh - VP of Investor RelationsSteve Michaels - President and CEOAnthony Chukumba - Managing DirectorConference Call ParticipantsBrad Thomas - Managing Director and Senior AnalystVincent Caintic - Managing Director and Specialty Finance AnalystOperatorGood day, and thank you for standing by. Welcome to the PROG Holdings Business Update conference call. At this time, all ...

PROCEPT BioRobotics (NasdaqGM:PRCT) FY Conference December 02, 2025 08:30 AM ET Company ParticipantsLarry Wood - CEOConference Call ParticipantsMatthew O'Brien - Senior Research AnalystMatthew O'BrienGood morning, everybody. Thanks for joining us. Matt O'Brien, one of the med tech analysts here at Piper. Extremely excited and lucky to have PROCEPT here joining us. From the company, we have Larry, who's the CEO, and then Kevin, who's the CFO of the company. Matt's down in the front row here, making sure I do ...

Gibson Energy (OTCPK:GBNX.F) 2025 Investor Day December 02, 2025 08:30 AM ET Company ParticipantsRiley Hicks - CFOKelly Holtby - SVP of Commercial Development for CanadaNone - Company RepresentativeBeth Pollock - VP of Capital Markets and Corporate DevelopmentDave Goss - SVP and COOSam Burwell - VPPatrick Kenny - Mnaging DirectorCurtis Philippon - President and CEOBlake Hotsell - SVP of CommercialConference Call ParticipantsMaurice Choy - AnalystBen Alexander - AnalystRobert Catellier - AnalystRobert Hope - ...

Viatris (NasdaqGS:VTRS) FY Conference December 02, 2025 08:30 AM ET Company ParticipantsDoretta Mistras - CFOPhilippe Martin - Chief R&D OfficerConference Call ParticipantsDavid Amsellem - Senior Research AnalystDavid AmsellemOkay, good morning, everyone. Let's kick things off. Welcome to the Piper Sandler Healthcare Conference. This is David Amsellem from the Biopharma Research Team, and we're delighted to have Viatris with us. Lots to talk about. We have Doretta Mistras, CFO, and Philippe Martin, Chief R& ...

Zoetis (NYSE:ZTS) Update / Briefing December 02, 2025 08:30 AM ET Company ParticipantsKristin Peck - CEORob Polzer - President of R&DKevin Esch - Senior VPWetteny Joseph - CFOKristin PeckGood morning, everyone, and welcome to our Innovation Webcast. It's truly an exciting time for animal health. Across our industry, we're seeing remarkable advances in science and technology, along with a growing appreciation for the essential role animals play in our lives and communities. The pace of innovation is accelera ...