Nuwellis (NUWE) Q4 2024 earnings summary

Executive summary

• Achieved nine new account wins in 2024 and entered the outpatient market for Aquadex technology following a favorable reimbursement change effective January 1, 2025.

• CMS increased reimbursement for Aquadex Ultrafiltration Therapy to $1,639 in outpatient settings, effective January 2025, supporting expansion opportunities.

• Published new clinical data in JACC: Heart Failure showing Aquadex therapy reduced heart failure events by 60% at 30 days compared to IV diuretics.

• Leadership transition underway with an interim CEO and an executive search firm engaged for a permanent replacement.

• Operating cost reductions of $5.9 million (26%) year-over-year, with continued efficiency initiatives.

Financial highlights

• Q4 2024 revenue was $2.3 million, a 9% year-over-year decrease due to lower U.S. console and international sales, partially offset by a 21% increase in consumables utilization.

• Gross margin improved to 58.4% from 54.4% in Q4 2023, driven by higher consumables manufacturing volumes and lower fixed overhead.

• Operating loss for Q4 was $2.4 million, improving from $3.6 million in Q4 2023.

• Net loss attributable to common shareholders was $1.5 million ($0.44 per share), a significant improvement from $7.9 million ($54.48 per share) in Q4 2023, aided by a $900,000 one-time gain from the termination of a distribution agreement.

• Cash and cash equivalents stood at $5.1 million at year-end 2024, with no debt.

Outlook and guidance

• Anticipates continued momentum in both inpatient and outpatient settings, leveraging increased reimbursement and new clinical evidence.

• Early traction in outpatient market with several existing accounts preparing to establish permanent outpatient facilities; broader impact expected in coming months.

• Ongoing enrollment in the REVERSE-HF trial, but timing for completion and top-line data remains uncertain.

• Expects continued market penetration and expansion in the outpatient setting.