Nuwellis (NUWE) Q2 2024 earnings summary

Executive summary

• Q2 2024 revenue reached $2.2 million, up 6% year-over-year, driven by increased consumables utilization in heart failure and critical care segments, while pediatric revenue declined due to lower census and consumables usage.

• Net loss attributable to common shareholders was $7.7 million, or $18.85 per share, compared to $4.8 million, or $127.65 per share, in Q2 2023.

• Operating loss narrowed to $2.3 million from $5 million year-over-year, reflecting significant cost reductions.

• First commercial sale and initial patient treatments of Quelimmune at Cincinnati Children's Hospital marked a milestone in pediatric critical care.

• Expanded Aquadex to pediatric patients in Florida and secured a purchase agreement with a 50-hospital network in Texas.

Financial highlights

• Gross margin improved to 67.2% from 55.3% in Q2 2023, attributed to higher manufacturing volumes and lower fixed overhead.

• SG&A expenses decreased to $3.2 million, and R&D expenses dropped to $558,000, both reflecting efficiency initiatives.

• Total operating expenses dropped 38% to $3.8 million.

• Cash and cash equivalents were $1.0 million as of June 30, 2024, with no debt.

• Net cash used in operating activities for the first half of 2024 was $5.6 million.

Outlook and guidance

• R&D spend expected to remain stable in the near term, with a potential increase as Vivian device development ramps up.

• Existing capital resources expected to support operations through October 31, 2024; additional capital will be sought via debt, equity, or a combination.

• Quelimmune guidance is limited due to the need for individual hospital IRB approvals; expansion depends on regulatory processes.

• REVERSE-HF trial remains on track for site enrollment completion by end of 2024 and patient enrollment by Q3 2025.

• Controlled, limited launch of Quelimmune targeting 10 hospitals by year-end.