Strong Revenue and EBITDA Beat
Q1 2026 net revenue $127.4M vs $39.1M in Q1 2025 (up ~226%), driven by DefenCath ($97.5M) and Melinta portfolio ($29.9M). Adjusted EBITDA $70M vs $23.6M (up ~197%), demonstrating significant margin expansion and core operating strength.
Raised Full-Year Guidance
Company raised FY2026 net revenue guidance from $300–320M to $325–345M (midpoint +~8%), adjusted EBITDA guidance from $100–125M to $115–135M (midpoint +~11%), and DefenCath revenue guidance from $150–170M to $175–195M (midpoint +~15.6%).
DefenCath Strong Utilization and Customer Adoption
Q1 DefenCath sales $97.5M; management reports durable utilization growth and increased customer run rates (utilization uptick Q4→Q1). Key large customers (U.S. Renal Care, IRC, Fresenius) published/announced positive real-world results, supporting clinical adoption.
REZZAYO Phase III (ReSPECT) Top-Line Success
ReSPECT met primary endpoint: fungal‑free survival at day 90 60.7% (REZZAYO) vs 59.0% (standard), demonstrating non-inferiority across Candida, Aspergillus and Nosocomial pathogens and favorable secondary safety endpoints (fewer TEAEs leading to dose changes/withdrawal). sNDA submission planned H2 2026 with potential commercial launch in 2027.
Strong Cash Generation and Balance Sheet
Ended Q1 with $178.1M cash, generated $42.4M cash from operations in Q1 (despite large incentive rebate payments), and increased cash by $33.3M in the quarter. Company executed $11.1M in share repurchases under buyback program.
Acquisition Contribution and Portfolio Expansion
Melinta acquisition (closed Aug 2025) contributed $29.9M revenue in Q1 2026 and expanded product portfolio, supporting both top-line growth and strategic pipeline diversification (including BARDA-partnered pediatric/biodefense programs).