Nuwellis, Inc. Q4 FY2025 earnings call

• 2025 was a year of structural change and repositioning. Manufacturing transitioned to KDI precision manufacturing for long-term reliability. International commercial strategy was refined with reduced exposure in certain markets.
• Fourth quarter revenue increased, with U.S. console sales and international sales growth. Gross margin improved. Full-year revenue declined, but pediatrics grew.
• Strengthened financial leadership with Carissa Schultz as CFO. Focus on operational discipline, capital management, and strategic clarity around the cardio-renal continuum, including pediatric program advancement with NIH grant.

Fourth quarter 2025: Revenue was $2.4 million, an increase of 4% compared to the prior year quarter and 9% sequentially. U.S. console sales increased 208%. International sales increased 59% year-over-year, while critical care revenue declined 24% sequentially. Gross margin for the fourth quarter was 68.2%, an improvement of 9.9 percentage points compared to the prior year quarter. Full year 2025: Revenue was $8.3 million, a 5% decrease compared to the prior year. Pediatrics grew 8% and 14% year-over-year respectively, partially offset by a 19% decline in critical care. Full-year gross margin was 62%, 3% lower than the prior year. Operating expenses for the full year were $16.2 million, slightly lower than the prior year. Net loss attributable to common shareholders for the full year was $17.5 million.

• 2026 financial priorities include gross margin consistency, disciplined expense management, enhanced visibility into commercial conversion, and prudent capital deployment.
• Objective to translate strategic clarity into more predictable commercial performance, concentrating resources in cardiorenal populations, integrating Rendia Tech acquisition, relaunching Clarity product mid-year, and progressing Vivian pediatric solution.

• Forward-looking statements involve material risks and uncertainties that could cause actual results to differ from anticipated.
• Risks related to market trends, estimated results, and performance, as well as those in the company's filings with the SEC.

Q: Talk about sales force focus and incorporation of RENvTech products.

A: Reinforced direct sales team, refocused business away from some international areas, terminated expensive trial, NIH grant for pediatrics, RENvTech's value in critical care with potential to measure urine analytes; sales team at 24, focus on increased utilization in existing accounts, primarily critical care with Rendia Tech to enhance utilization in heart failure accounts