Nuwellis (NUWE) investor relations material

Executive summary

• Q3 2025 net sales were $2.2M, down 6–6.3% year-over-year, mainly due to lower international sales and prior year one-time items; nine-month sales were $5.8M, down 8.9%.

• Growth was driven by critical care, pediatrics, and heart failure, with new product launches and expanded adoption of Aquadex therapy, including first hospital-based outpatient therapies.

• Operational focus included U.S. market expansion, manufacturing transition to KDI Precision Manufacturing, and exit from European/international operations.

• The company terminated the REVERSE-HF clinical trial to prioritize higher-impact areas and expects $4M in savings over 2.5 years.

• Net income for Q3 2025 was $0.5M, driven by a $3.2M gain from warrant liabilities; nine-month net loss was $15.1M.

Financial highlights

• Q3 2025 revenue was $2.2M, down 6–6.3% year-over-year, but up 29% sequentially; proforma revenue grew 7% year-over-year excluding one-time and international impacts.

• Gross margin was 65.2%, down from 70% in Q3 2024, due to underabsorption of fixed overhead and unfavorable manufacturing variances.

• Operating expenses were $4.1M, up 30% year-over-year, reflecting investments in U.S. sales and engineering.

• Operating loss was $2.7M, compared to $1.5M in Q3 2024.

• Cash and cash equivalents at quarter end were $3.1M, down from $5.1M at year-end 2024; company remains debt-free.

Outlook and guidance

• Management anticipates continued U.S.-focused growth, leveraging new product launches and expanded outpatient therapy access.

• Expectation of incremental cost efficiency and margin expansion from the KDI Precision Manufacturing transfer starting next year.

• Existing capital resources are expected to support operations into Q1 2026; additional capital will be sought for growth and strategic initiatives.

• The company expects continued losses in the near term as it invests in U.S. market expansion and product development.