Nuwellis, Inc. Q4 FY2024 earnings call

• John Erb thanked Nestor Jaramillo for his contributions and stated he is working as interim CEO while searching for a permanent one. - In 2024, there were 9 new account wins. - A favorable reimbursement change effective January 1st 2025 allows entry into the outpatient market for Aquadex technology. - Fourth quarter gross margin was 58.4% due to higher consumables manufacturing volumes and lower fixed overhead. - SG&A expenses in the fourth quarter were $2.9 million, an improvement of approximately 19% from the prior year. - R&D expenses in the fourth quarter were $831,000, a decrease from the prior year period. - Operating loss in the fourth quarter was $2.4 million, an improvement of $1.2 million from the prior year.

Nuwellis generated $2.3 million in revenue for the fourth quarter of 2024, a 9% decrease year-over-year due to a decline in U.S. console sales and international sales, offset by a 21% increase in consumables utilization. The Critical Care business, the largest customer category, posted a 35% year-over-year quarterly revenue growth. Heart failure and pediatrics customer categories were down 36% and 20% respectively on lower console sales.

• Expect continued momentum in 2025 with clinical data growth and outpatient reimbursement opportunity. - Excited about strategic initiatives to build clinical evidence for Aquadex to be a standard of care. - Anticipate top line growth from outpatient market penetration. - Reverse HF trial is ongoing to further validate benefits.

• Forward-looking statements involve material risks and uncertainties that could cause actual results to differ from expectations. - Risks related to market trends, estimated results, and assumptions used in forward-looking statements.

Q: Can you guys describe any initial traction in the outpatient setting for Aquadex given that January 1st reimbursement change?

A: Traction is beginning with existing accounts working towards setting up permanent outpatient facilities, but it will take another month or so to see full online activity.

Q: How many Aquadex units, consoles were placed in 4Q ‘2024? And could you remind us what that number is also for 3Q ‘2024?

A: Q4 2024 sold 3 units, 3Q 2024 sold 11 units.

Q: Is it possible to guide us on when reverse HF trial will complete enrollment?

A: Difficult to gauge, continuing to enroll but premature to predict.

Q: How are you as interim CEO, any immediate changes, and search for permanent CEO?

A: No immediate big changes needed, search firm hired, some candidates reached out to and passed to search firm.