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Nuwellis(NUWE) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for the second quarter was CAD1.7 million, a year-over-year decline of 21% [5][13] - Gross margin for the quarter was 55.5%, down from 67.2% in Q2 2024 [14] - Operating loss for Q2 was $2.9 million compared to $2.3 million in Q2 2024 [15] - Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per share, compared to a net loss of $7.7 million, or a loss of $791.22 per share for the same period in 2024 [15] Business Line Data and Key Metrics Changes - Pediatric revenues increased by 23% compared to 2024 [13] - Heart failure and critical care revenues declined by 53% and 35% respectively, significantly impacted by the temporary backorder [13] Market Data and Key Metrics Changes - The pediatrics business remains strong with ongoing interest from new centers [7] - The outpatient heart failure opportunity is expected to grow due to increased reimbursement rates [23] Company Strategy and Development Direction - The company is focused on strengthening fundamentals, operational discipline, and strategic investments in high-impact growth areas [5] - Key growth areas identified include cardiac surgery, pediatrics, and outpatient heart failure [11][17] - The transition to KDI precision manufacturing is planned for October, expected to yield operational efficiencies and cost savings [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating temporary setbacks and emphasized a commitment to delivering value to patients and shareholders [16] - The company aims to progress towards being cash flow positive and deepen outpatient engagement with heart failure programs [17] Other Important Information - The company ended the REVERSE HF clinical trial to reallocate approximately $4 million towards higher impact growth areas [10] - The company ended the quarter with $4.5 million in cash and cash equivalents and remains debt-free [15] Q&A Session Summary Question: Resolution of sterilization vendor issue and impact on Q3 - The issue was resolved in July, and the company is no longer in backorder, rapidly building finished goods inventory [20][21] Question: Largest opportunity among pediatrics, critical care, and heart failure - Management sees growth opportunities in all three areas, with heart failure expected to grow the fastest due to outpatient opportunities and increased reimbursement [22][23]