Nuwellis, Inc. Q2 FY2024 earnings call

• Revenue for Q2 2024 was $2.2 million, up 6% YoY due to increased heart failure and critical care consumables utilization. - Pediatric segment had 10% revenue decline, but expanded Aquadex to a large Florida hospital network in mid-May. - Announced first commercial sale of QUELIMMUNE to Cincinnati Children's Hospital, a milestone in pediatric market penetration. - Gross margin was 67.2% in Q2 2024, up from 55.3% in Q2 2023 due to higher manufacturing volumes and lower fixed overhead. - SG&A expenses decreased 31% to $3.2 million in Q2 2024. - R&D expenses dropped to $558,000 in Q2 2024 from $1.5 million in Q2 2023. - Ended Q2 with $1 million in cash and no debt; closed a $2 million registered direct offering in July.

For the second quarter of 2024, Nuwellis generated $2.2 million in revenue, a 6% year-over-year increase. The heart failure and critical care consumables segment saw a 30% increase in utilization, driving growth. The pediatric segment had a 10% revenue decline, with console sales increase offset by consumables utilization decrease due to soft census in pediatric kidney disease. Heart failure and critical care contributed significantly to revenue growth, while pediatric was impacted by census softness. Revenue contribution: Heart failure and critical care drove the 6% YoY growth, pediatric had a 10% decline.

• R&D spend is expected to pick up with development of Vivian's software. - QUELIMMUNE has a control-limited launch target of reaching 10 hospitals by the end of 2024. - Reverse HF trial enrollment is ongoing, with expectation to complete patient enrollment by Q3 2025.

• DaVita pilot progress slower than anticipated due to contract amendments and protocol creation within hospitals. - IRB approvals required for each hospital for QUELIMMUNE, which is a time-consuming process. - Slower enrollment in the reverse HF trial attributed to summer months and complex interactions between parties.

Q: Can you talk about R&D trend guidance and if it's representative going forward?

A: R&D spend is anticipated to continue at current levels but may pick up with Vivian's software development.

Q: Talk about pediatric revenue percent and Florida hospital network progress with Aquadex?

A: Pediatric represents about 30% of revenue; one pediatric account opened this quarter, total 41 accounts using Aquadex. Positive traction in the 50 hospital network for Aquadex.

Q: Update on QUELIMMUNE patient treatment and DaVita pilot progress?

A: There have been multiple patients treated at Cincinnati Children's Hospital with QUELIMMUNE. DaVita pilot progress slower due to contract amendments and protocol creation in hospitals.

Q: Traction with 50 hospital network for Aquadex?

A: Good traction in the 50 hospital network, with hospital administration already familiar with Nuwellis.