Fractyl Health, Inc. (GUTS) Discusses Commercialization Strategy for Investigational Post

Fractyl Health, Inc. (GUTS) Discusses Commercialization Strategy for Investigational Post-GLP-1 Procedural Therapy September 1, 2026 11:00 AM EDT Company Participants Brian Luque - Head of Investor Relations & Corporate Development Harith Rajagopalan - Co-Founder, CEO & Director Mike Zumdahl - Senior Vice President of Market Access & Commercial Strategy Lara Weber - CFO & Treasurer Conference Call Participants Folahan Ayoola Michael DiFiore - Evercore ISI Institutional Equities, Research Division Angela Qian - Canaccord Genuity Corp., Research Division Chase Knickerbocker - Craig-Hallum Capital Group LLC, Research Division Rohit Bhasin - Morgan Stanley, Research Division Jason Gerberry - BofA Securities, Research Division Jeffrey Cohen - Ladenburg Thalmann & Co. Inc., Research Division Joseph Pantginis - H.C. Wainwright & Co, LLC, Research Division Presentation Operator Good morning, and welcome to the Fractyl Health Commercial Strategy Day. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be available on the Fractyl Health website following the conclusion of the event. I will now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractyl Health. Please go ahead, Brian. Brian Luque Head of Investor Relations & Corporate Development Good morning, everyone, and thanks for joining us. I'm Brian Luque, Head of Investor Relations and Corporate Development at Fractyl Health. Today is our Commercial Investor Day. Our purpose this morning is to walk you through how we intend to commercialize Revita, our investigational procedural therapy for post-GLP-1 weight maintenance, assuming we're successful in our pivotal trial and in our regulatory submission. Before we begin, I'll turn to the legal disclaimer. During this presentation, we'll be making forward-looking statements, including statements about the timing and results of the REMAIN-1 pivotal cohort, our regulatory strategy and the potential use of the de novo pathway, coding, coverage and payment, the timing and content of a potential commercial launch, our expected financial performance, the potential sales and estimated