Nuwellis — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net sales for the three months ended September 30, 2026, were $2.2 million, essentially unchanged from the prior-year quarter, driven by a $0.4 million backorder fulfillment in the prior year; sales increased 12% sequentially.
• Net sales for the nine months ended September 30, 2026, increased 13% to $6.6 million compared to $5.8 million in the prior-year period.
• Gross margin expanded to 69.5% in the third quarter of 2026 from 65.2% in the prior-year quarter, and improved to 71.7% year-to-date from 59.4% in the prior-year period, attributed to higher average selling prices and contract manufacturing efficiencies.
• Operating expenses decreased to $3.6 million in the third quarter of 2026 from $4.1 million in the prior-year quarter, reflecting a 13% reduction.
• Loss from operations improved 24% year-over-year to $2.1 million in the third quarter of 2026, compared to $2.7 million in the prior-year quarter.
• Net loss for the third quarter of 2026 was $2.0 million, compared to a net income of approximately $0.5 million in the prior-year quarter, which included a significant noncash gain from changes in the fair value of warrant liabilities.
• Cash and cash equivalents stood at $8.3 million as of September 30, 2026, up from $1.1 million at December 31, 2025.
• Total assets increased to $13.4 million as of September 30, 2026, from $6.1 million at December 31, 2025.
• Total liabilities increased to $3.6 million as of September 30, 2026, from $3.5 million at December 31, 2025.
• Warrant liabilities were recorded at $399,000 as of September 30, 2026.
• Financing expense for the nine months ended September 30, 2026, was $6.1 million, compared to $10.6 million in the prior-year period.
• Change in fair value of warrant liabilities contributed a $4.5 million gain for the nine months ended September 30, 2026.

Guidance and Future Outlook:

• Management stated that the expanded installed base of consoles creates a larger opportunity to grow recurring circuit revenue.
• The company expressed belief that recent strategic achievements position it for sustainable growth and long-term value creation.
• Forward-looking statements indicate anticipated growth in 2026 and beyond, subject to risks including execution of commercialization strategy and ability to raise sufficient funds.

Business Segments and Product Lines:

• The pediatric segment remained a significant growth driver, with net sales increasing 20% in the third quarter of 2026 and 26% year-to-date compared to prior-year periods.
• Console unit sales increased 88% year-to-date, with 32 Aquadex consoles sold in the first nine months of 2026 compared to 17 in the prior-year period.
• Eight Aquadex consoles were sold in the third quarter of 2026, compared to 12 in the prior-year quarter.
• The company submitted a 510(k) premarket notification to the FDA to expand the Aquadex SmartFlow System indication to include pediatric patients weighing five kilograms and above.
• A multicenter study titled "Kidney Support in Infants and Children using Aquadex: Findings From the ULTRA-Peds Registry" was accepted for publication in Pediatric Nephrology.
• Entered into a co-promotion and distribution agreement with Atrility Medical for its AtriAmp postoperative cardiac rhythm monitoring device.
• Secured exclusive U.S. distribution rights for the pediatric Zorro-Flow external urine collection system.
• Intangible assets increased to $93,000 as of September 30, 2026, from zero at December 31, 2025.

Market and Competitive Landscape:

• The company leverages its existing pediatric and critical care sales force to support new product distribution agreements.
• The transition to a contract manufacturing model has provided benefits to gross margins.
• The company focuses on safety, precision, and scalability across patient populations in cardiorenal conditions.

Risks and Challenges:

• Risks include the ability to execute on commercialization strategy, potential inability to raise sufficient funds for operations, and post-market clinical data collection activities.
• Risks also encompass benefits of products to patients, product development and commercialization expectations, market and physician acceptance, competitive product offerings, and intellectual property protection.
• Risks associated with integrating acquired businesses and realizing anticipated synergies were noted.

Management Commentary and Tone:

• Mike McCormick, President and Chief Executive, highlighted meaningful progress in strengthening the company commercially and financially, noting that console unit sales nearly doubled year-to-date.
• Management acknowledged the tough comparison against the prior-year quarter due to backorder fulfillment but emphasized strong underlying momentum in the pediatric segment.
• Management cited disciplined cost management and gross margin expansion as key drivers in narrowing the operating loss and cash use.
• Management expressed confidence that the 510(k) submission and new distribution agreements broaden the product offering in a capital-efficient manner.

Other Key Points:

• In July 2026, the Company raised $3.4 million in gross proceeds from a direct offering.
• Concurrently with the direct offering, the Company received $3.3 million in gross proceeds from the cash exercise of warrants.
• During the third quarter of 2026, the Company received $1.4 million in net proceeds from common shares sold under its ATM (At-The-Market) program.
• The Company acquired Rendiatech, resulting in deferred consideration of $113,000 (current) and $200,000 (non-current) as of September 30, 2026.
• Non-cash IP R&D from the Rendiatech acquisition was recorded at $757,000 for the nine months ended September 30, 2026.
• Series C warrants were converted to equity with a value of $5.0 million during the nine months ended September 30, 2026.
• Series D warrant exercises generated $1.4 million in proceeds during the nine months ended September 30, 2026.
• Common stock issued as consideration in the asset acquisition totaled $162,000, with deferred costs issued as consideration totaling $313,000.
• Series J Convertible Preferred Stock increased from 137 shares outstanding at December 31, 2025, to 170 shares outstanding at September 30, 2026.
• Series F Convertible Preferred Stock decreased from 127 shares outstanding at December 31, 2025, to 27 shares outstanding at September 30, 2026.
• Common stock issued and outstanding increased to 540,912 shares as of September 30, 2026, from 5,342 shares at December 31, 2025.
• A conference call and webcast were scheduled for 9:00 a.m. Eastern time on November 12, 2026.