Nuwellis, Inc. Q1 FY2025 earnings call

• First quarter results: Revenue up 3% y-o-y with growth in pediatrics and heart failure. - Clinical support: Journal of the American College of Cardiology Heart Failure published AVOID-HF trial findings showing 60% reduction in heart failure events, and Outcomes and Community Hospitals study showed reduced heart failure readmission rates. - Reimbursement: Aquadex reassigned to new outpatient reimbursed level by CMS, increasing facility reimbursement fee nearly 4x to $1,639 per day. - Outpatient strategy: Building pipeline of target outpatient facilities, with momentum in outpatient setting. - Manufacturing: Products manufactured in-house in Minnesota with only small portion of raw materials sourced internationally.

Nuwellis generated $1.9 million in revenue for the first quarter of 2025, a 3% increase year-over-year. Consumables utilization grew 4% and U.S. console sales increased, partially offset by a decrease in international sales. By customer category, pediatrics saw 38% growth and heart failure 28% growth, driven by consumable utilization increase. Critical care sales decreased 25% due to one large customer acquiring excess inventory in late 2024. Critical care represents approximately 40% of current business, pediatrics ~40%, and the outpatient heart failure market is an addressable opportunity of ~$773 million.

• Continue progress into the year, capitalizing on momentum to position Aquadex as standard of care. - Expect outpatient market expansion as hospitals implement clinics and start treating patients, with growth expected in later quarters. - Continuing patient enrollment in REVERSE-HF clinical study, nearing halfway mark of 372 patients. - Vivian clinical trial to start later this year/early next year after further device development and FDA IDE submission.

• Tariffs: Limited exposure as manufacturing is in-house with small international raw material sourcing. - Operational: Logistical challenges for hospitals in implementing outpatient clinics, though working through these.

Q: Jonathan Aschoff asked about the drop in critical care sales and if it's seasonal.

A: John Erb said it was due to a large customer acquiring excess inventory in Q4 2024, not seasonality, and expects critical care to stabilize.

Q: Asked about expanding outpatient pipeline and outpatient application of Aquadex.

A: Hospitals are identifying locations and nursing resources for outpatient clinics, expecting revenue growth starting this quarter.

Q: Asked about Phase 3 trial enrollment and Vivian trial timeline.

A: REVERSE-HF trial enrollment nearing halfway, issues from Q4 recall solved, and Vivian trial to start later this year/early next year after device development and FDA IDE submission.