Core Insights - OPKO Health and Entera Bio announced a first-in-class oral GLP-2 analog for treating Short Bowel Syndrome (SBS), selected for a poster presentation at the ESPEN Congress in September 2025 [1][2] Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing industry-leading positions in rapidly growing markets through its discovery, development, and commercialization expertise [6] - Entera Bio is a clinical-stage company developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology for significant unmet medical needs [5] Product Development - The oral GLP-2 tablet program combines OPKO's long-acting GLP-2 agonist with Entera's N-Tab™ technology, aimed at patients with SBS and related gastrointestinal disorders [2] - Current approved therapy for SBS, GATTEX (teduglutide), generates approximately $800 million in annual sales and requires daily subcutaneous injections [4] Market Context - Short Bowel Syndrome affects around 30,000 patients in the US and EU, leading to malabsorption and increased risk of malnutrition [4] - The introduction of an oral tablet format for GLP-2 therapy may improve patient compliance and enable personalized treatment [3]

Financial Data and Key Metrics Changes - For the full year 2024, the company achieved $916 million in net sales, meeting its financial guidance [14] - GAAP net income for 2024 was $1.8 million, with adjusted EBITDA of $100.6 million [28] - Total revenue for 2024 was $351.4 million, with cash and cash equivalents at $88.6 million at year-end [27][28] Business Line Data and Key Metrics Changes - LINZESS saw a 12% increase in prescription demand growth in Q4 2024 compared to Q4 2023, and 11% growth year-over-year for 2024 [13] - New-to-brand volume growth for LINZESS was 11% in Q4 2024 and 14% for the full year, marking eight consecutive quarters of double-digit growth [13] - Collaborative arrangements revenue was $88.4 million in Q4 2024 and $340.4 million for the full year [26] Market Data and Key Metrics Changes - The company is experiencing stabilization in Medicare utilization, which was a headwind in 2024, particularly in the second half of the year [14] - The market for short bowel syndrome is characterized by a smaller prescriber base, primarily located in specialized centers [11] Company Strategy and Development Direction - The company is focused on advancing apraglutide, aiming for it to become a blockbuster therapy for short bowel syndrome [7][9] - A rolling submission of the NDA for apraglutide has been initiated, with completion expected in Q3 2025 [9][19] - The company plans to implement a robust patient support service model for apraglutide, ensuring seamless care from prescription to treatment [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for LINZESS, despite anticipated pricing headwinds due to Medicare Part D redesign [14][30] - The company is focused on generating sustained profits and cash flows to support the advancement of apraglutide and repay debt [29][31] - Management is optimistic about the clinical evidence supporting apraglutide's potential to change treatment paradigms for short bowel syndrome [32] Other Important Information - The company reduced its total debt balance by approximately $115 million over the past 12 months [29] - The company has access to roughly $254 million in liquidity, including cash and undrawn revolver capacity [29] Q&A Session Summary Question: Confidence in initial learnings from virtual-based marketing and volume growth - Management indicated strong marketing support for LINZESS, with positive ROI from consumer advertising driving growth [37][40] Question: Cost savings recognition and R&D spending - Full impact of cost savings will be seen in Q2 2025, with R&D spending expected to remain stable in 2025 and potentially decrease in 2026 [44][45] Question: Confidence in maintaining compliance on debt covenants - Management expressed high confidence in maintaining covenant compliance throughout 2025 [50][51] Question: Patient characteristics achieving enteral autonomy with apraglutide - Patients achieving enteral autonomy include both stoma and CIC patients, with a significant number maintaining this status [56][59] Question: Timing of Medicare Part D redesign impact on LINZESS revenues - Management believes the impact will be more pronounced in the second half of 2025, but guidance accounts for this redesign [62][64] Question: Launch expenses for apraglutide and 2026 convertible notes - Launch expenses for apraglutide will ramp up as the launch date approaches, with a focus on strengthening the balance sheet to manage existing debt [68][70]