• Revenue: $2.3 million for Q4 2024, a 9% decrease year-over-year.
• Consumables Utilization: Increased by 21% in Q4 2024.
• Critical Care Revenue Growth: 35% year-over-year increase in Q4 2024.
• Heart Failure Revenue: Decreased by 36% in Q4 2024.
• Pediatrics Revenue: Decreased by 20% in Q4 2024.
• Gross Margin: 58.4% in Q4 2024, up from 54.4% in the prior-year quarter.
• Selling, General, and Administrative Expenses: $2.9 million in Q4 2024, a 19% decrease from Q4 2023.
• Research and Development Expense: $831,000 in Q4 2024, down from $1.4 million in Q4 2023.
• Total Operating Expenses: $3.7 million in Q4 2024, a 25% decrease from Q4 2023.
• Operating Loss: $2.4 million in Q4 2024, improved from $3.6 million in Q4 2023.
• Net Loss Attributable to Common Shareholders: $1.5 million or $0.44 per share in Q4 2024, compared to $7.9 million or $54.48 per share in Q4 2023.
• Cash and Cash Equivalents: $5.1 million as of December 31, 2024, with no debt.

• Warning! GuruFocus has detected 3 Warning Signs with NUWE.

Release Date: March 11, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Nuwellis Inc (NASDAQ:NUWE) reported a 21% increase in consumables utilization, indicating growing adoption of their Aquadex system.
• The company achieved 35% year-over-year revenue growth in their critical care business, driven by higher console sales and consumable utilization.
• A recent peer-reviewed publication in JACC: Heart Failure demonstrated a 60% reduction in heart failure events at 30 days for patients using Aquadex therapy compared to traditional IV diuretics.
• Nuwellis received a favorable reimbursement change from CMS, increasing the facility reimbursement fee for Aquadex ultrafiltration therapy nearly fourfold, effective January 1, 2025.
• The company has no debt on its balance sheet, providing financial stability and flexibility for future initiatives.

Negative Points

• Nuwellis Inc (NASDAQ:NUWE) experienced a 9% decline in revenue for the fourth quarter of 2024 due to lower US console sales and international sales.
• Heart failure and pediatric customer categories saw revenue declines of 36% and 20%, respectively, due to lower console sales.
• The company had a voluntary recall of specific lots of blood circuit units, resulting in a non-recurring expense of approximately $150,000.
• Operating loss for the fourth quarter was $2.4 million, although this was an improvement from the previous year.
• The REVERSE-HF trial enrollment and the start of the Vivian clinical trial remain difficult to gauge, indicating potential delays in clinical validation efforts.

Q & A Highlights

Q: Can you describe any initial traction in the outpatient setting for Aquadex given the January 1 reimbursement change? A: John Erb, Interim CEO, mentioned that traction is beginning with several existing accounts setting up more permanent facilities for outpatient treatment. It may take another month or so to see these come online, but there is promising initial activity.

Q: How many Aquadex units were placed in Q4 2024, and what was the number for Q3 2024? A: Robert Scott, CFO, stated that 3 units were sold in Q4 2024, while 11 units were sold in Q3 2024.

Q: Can you guide us on when the REVERSE-HF trial will complete enrollment? A: John Erb, Interim CEO, indicated that it is difficult to predict the completion of enrollment. They are pleased with the investigators' involvement but cannot provide a specific timeline at this point.

Q: As you take over as interim CEO, are there any changes you plan to implement, and has the search for a permanent CEO begun? A: John Erb, Interim CEO, stated that there is no immediate need for big changes as the team is effective. The focus is on leveraging recent clinical evidence and reimbursement changes. A search firm has been hired for the CEO search, and some candidates have been identified.

Q: What are the key growth initiatives for Nuwellis in 2025? A: John Erb, Interim CEO, highlighted the focus on building clinical evidence and leveraging the improved CMS reimbursement for ultrafiltration in the outpatient setting. These initiatives aim to position Aquadex as a preferred solution in both inpatient and outpatient settings.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.