CRMD Up More Than 40% YTD: Time to Buy, Sell or Hold the Stock?

Core Insights - CorMedix (CRMD) shares have surged 41.4% year-to-date, outperforming the industry (16.9% rise) and the S&P 500 [1][2] Product Performance - DefenCath, the company's lead therapy, was approved by the FDA in late 2023 as the first antimicrobial catheter lock solution in the U.S. [4] - DefenCath aims to reduce catheter-related bloodstream infections (CRBSIs) in adults with kidney failure undergoing hemodialysis [4] - In the first nine months of 2025, DefenCath generated $167.6 million in net sales, indicating strong market adoption [7] - The product is expected to continue growing due to higher outpatient utilization and potential label expansion into total parenteral nutrition [9] Acquisition Impact - CorMedix acquired Melinta Therapeutics for $300 million, adding seven therapies to its portfolio and diversifying revenue streams [10] - The Melinta acquisition contributed $12.8 million to CRMD's revenue in Q3 2025 [11] - Management sees a total addressable market exceeding $2 billion for antifungal prophylaxis, indicating significant growth potential [13] Competitive Landscape - CorMedix holds a first-mover advantage with DefenCath, but faces competition from major players like Pfizer and Amphastar Pharmaceuticals [14][15] - These competitors have stronger pipelines and resources, posing risks to CorMedix's market position [15][16] Financial Outlook - CorMedix shares trade at a price/book ratio of 2.40, below the industry average of 3.51 [17] - Earnings estimates for 2025 have improved from $1.85 to $2.87 per share, and for 2026 from $2.49 to $2.88 [18] - The company raised its full-year 2025 revenue guidance to $390-$410 million, up from at least $375 million [19] Investment Recommendation - Despite competitive risks, CorMedix's unique positioning and growing portfolio suggest an optimistic outlook, making it a strong buy at current valuations [21]