Announcement • May 23
Seegene Launches Allplex MDRO Assay Under IVDR Seegene announced the European launch of its new antimicrobial resistance (AMR) testing product, Allplex MDRO Assay, which is CE marked under the EU In Vitro Diagnostic Regulation (IVDR). The assay is designed to support the detection of multidrug-resistant organisms (MDROs) associated with healthcare-associated infections (HAIs). The assay is designed to identify key multidrug-resistant pathogens and associated resistance genes in a single run, enabling rapid simultaneous detection across a broader range of MDRO targets. It also supports rapid first-line screening before the availability of culture-based results, helping enable timely infection prevention and control (IPC) responses in hospital settings. The launch reflects Seegene's strategy to expand its AMR testing capabilities in response to evolving infectious disease trends. As antimicrobial resistance continues to rise globally, the burden of healthcare-associated infections is increasing, driving demand for faster and more comprehensive diagnostic approaches. Public health agencies, including the U.S. Centers for Disease Control and Prevention (CDC), have continued to emphasize the importance of strengthened infection surveillance and control capabilities in healthcare settings. The Allplex MDRO Assay complements Seegene's existing Allplex Entero-DR Assay, enabling a combined testing approach that covers both antimicrobial-resistant enteric bacteria and additional high-risk MDRO targets. This combined approach can support broader infection-control efforts against antimicrobial-resistant organisms, while strengthening Seegene's overall AMR testing portfolio. The assay enables simultaneous detection of multiple resistance genes and can support same-day reporting depending on laboratory workflow. This can provide timely information to support infection-control responses and complement conventional culture-based workflows. It may also help support more efficient laboratory workflows in appropriate clinical settings. Seegene plans to further strengthen its diagnostic capabilities for healthcare-associated infections and advance its strategy in line with growing demand for enhanced infection surveillance and control. Product availability may vary by country and is subject to local regulatory requirements. The company is also developing the Allplex MRSA Assay for detection of methicillin-resistant Staphylococcus aureus (MRSA), which is targeted for launch next year as part of its broader AMR testing portfolio expansion strategy. Major Estimate Revision • May 14
Consensus EPS estimates increase by 52%, revenue downgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from ₩532.0m to ₩517.8m. EPS estimate rose from ₩1,116 to ₩1,697. Net income forecast to grow 84% next year vs 27% growth forecast for Biotechs industry in South Korea. Consensus price target of ₩39,500 unchanged from last update. Share price rose 33% to ₩32,000 over the past week. Valuation Update With 7 Day Price Move • May 11
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to ₩28,250, the stock trades at a forward P/E ratio of 25x. Average forward P/E is 21x in the Biotechs industry in South Korea. Total returns to shareholders of 34% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at ₩53,224 per share.