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- **Revenue Mixed but Pro Forma Growth**: Q3 revenue $2.2M (-6% YoY), but pro forma +7% excluding one-time items. Sequential rise 29% driven by consumables and console sales.
- **Product Innovation Driving Adoption**: New 24-hour circuit and dual-lumen catheter expand outpatient use; 92% survival rate in pediatrics highlights clinical impact.
- **Financial Challenges and Strengths**: Gross margin decline to 65.2% due to manufacturing costs, but strong cash position ($3.1M) and $5.9M equity raise support growth.
- **Strategic Shifts**: Exiting international markets, transitioning manufacturing, and advancing outpatient care model to drive long-term growth.

**【CEO Summary Section】**
- **Q3 Momentum and Strategic Focus**: Highlighted progress in critical care, pediatrics, and heart failure with Aquadex therapy adoption. Introduced new 24-hour Aquadex circuit and dual-lumen catheter to enhance flexibility and scalability.
- **Pediatric Innovation**: Advanced Vivien CRRT system development with U.S. patent allowances and 92% survival rate data from ULTRA-Peds registry.
- **Operational Shifts**: Transitioned manufacturing to KDI, exited European operations, and raised $5.9M in equity to support U.S. growth.
- **Outpatient Expansion**: Delivered first Aquadex therapy in hospital-based outpatient setting under new CMS code, signaling proactive care model.

**【CFO Financial Commentary】**
- **Revenue Performance**: Q3 revenue $2.2M (-6% YoY), pro forma growth 7% excluding one-time SeaStar sales. Sequential increase 29% driven by 15% rise in consumables utilization and 4x U.S. console sales.
- **Gross Margin**: 65.2% (vs. 70% YoY) due to under-absorbed fixed overhead; expects margin expansion post-KDI transition.
- **Expense Growth**: Operating expenses $4.1M (+30% YoY) from sales force rebuild and R&D investments. Net income $0.56/share vs. $73.23 prior year (adjusted for reverse split).
- **Liquidity**: $3.1M cash, debt-free, with $5.9M raised in Q3 and June to support 2026 strategy.

**【Closing Remarks】**
- **Future Focus**: Emphasized three growth engines (critical care, pediatrics, outpatient heart failure) and thanked departing CFO Rob Scott for his contributions.

Nuwellis, Inc.(NUWE)-20251112-2025 Q3 Earnings call transcript

- **Q2 revenue decline**: $1.7M (-21% YoY) due to $400K sterilization backorder, now resolved.
- **Pediatrics strength**: +23% YoY growth, Aquadex uniquely approved for <20kg patients.
- **Strategic shifts**: 
  - $4M REVERSE-HF trial termination to fund growth
  - KDI manufacturing transition for cost savings
- **Outpatient opportunity**: 7 hospitals launching clinics with +344% reimbursement rate.
- **Financial health**: $4.5M cash, $12.6M net loss (-40% YoY loss per share).

**【Management Opening Remarks】**
- Nuwellis issued a press release detailing Q2 2025 financial results, with a reminder of forward-looking statement disclaimers.

**【CEO Summary Section】**
- Q2 revenue: $1.7 million (21% YoY decline), impacted by a $400,000 sterilization vendor backorder resolved in early July.
- **Pediatrics growth**: +23% YoY, driven by demand for Aquadex in small children with kidney dysfunction.
- **Critical care adoption**: Increasing use post-cardiac surgery for fluid management.
- **Heart failure focus**: Outpatient clinics leveraging $1,639/day reimbursement, with 7 hospitals setting up programs.
- Strategic moves:
  - Manufacturing transition to KDI Precision (Q4 2025 go-live) for cost savings.
  - Terminated REVERSE-HF trial, reallocating $4 million to high-impact growth areas.

**【CFO Financial Commentary】**
- **Revenue by category**: 
  - Pediatrics: $1.2M (65% of total)
  - Heart Failure: $0.3M (-53% YoY)
  - Critical Care: $0.2M (-35% YoY)
- **Gross margin**: 55.5% (-11.7pts YoY) due to under-absorbed overhead.
- **Operating expenses**: $3.9M (+2% YoY), with R&D up 21% to $0.7M.
- **Net loss**: $12.6M (-40% YoY loss per share), with $4.5M cash and no debt.
- **Capital raise**: $5M gross to support growth initiatives.

**【Q&A Highlights】**
- **Vendor resolution**: Sterilization backorder resolved in early July, inventory replenished.
- **Growth priorities**: 
  - Pediatrics (FDA-cleared for <20kg patients)
  - Cardiac surgery (post-op fluid management)
  - Outpatient heart failure (7 clinics launching)
- **Outpatient focus**: 1st patient treated in July at Prisma Richland, targeting cash flow positive by end-2025.

- **Revenue Resilience**: Q1 2025 revenue up 3% YoY, driven by pediatric and heart failure growth despite critical care volatility.
- **Clinical Validation**: Aquadex reduces heart failure readmissions by 60% in real-world data; new CMS reimbursement boosts outpatient viability.
- **Cost Efficiency**: 31% YoY operating expense reduction to $4.1M; manufacturing outsourcing to cut costs further.
- **Outpatient Expansion**: $773M market opportunity with 4 hospitals launching outpatient clinics this quarter.
- **Pipeline Momentum**: REVERSE-HF trial halfway to enrollment; Vivian trial IDE submission expected late 2025.

**【CEO Opening Remarks】**
- Q1 2025 Revenue: $1.9M (+3% YoY), driven by 4% increase in consumables utilization and U.S. console sales.
- Key Growth Areas: Pediatrics (+38% YoY) and Heart Failure (+28% YoY) due to higher consumable usage.
- Critical Care Decline: 25% YoY drop due to a major customer's inventory buildup; expected normalization in Q2.
- Clinical Momentum: Aquadex shown to reduce heart failure readmissions by 60% in real-world data; new CMS outpatient reimbursement rate (+4x to $1,639/day) expands market access.
- Outpatient Strategy: Targeting $773M addressable market with 4 hospitals preparing to launch outpatient clinics this quarter.
- Tariff Resilience: Minimal international raw material reliance; no material impact from tariffs.

**【CFO Financial Highlights】**
- Gross Margin: 56% (vs. 64.1% YoY), down due to manufacturing variances and inventory adjustments.
- Operating Expenses: $4.1M (-31% YoY), with SG&A down 22% to $3.6M and R&D down 58% to $0.55M.
- Cash Position: $2.6M; no debt; focused on disciplined expense management.

**【Q&A Key Takeaways】**
- Pediatric Growth Sustainability: 2 new hospital accounts added; Aquadex uniquely suited for low blood volume pediatric cases.
- Outpatient Rollout Timeline: 4 hospitals launching Q2; expect meaningful revenue contribution from Q3 onward.
- Clinical Trial Progress: REVERSE-HF trial halfway to 372 patient enrollment; Vivian trial IDE submission expected late 2025.
- Cost Optimization: Manufacturing outsourcing to KDI expected to reduce expenses over next 12 months.

Nuwellis (NUWE)-13 May 25-2025 Q1 Earnings call transcript

- **Revenue resilience**: -9% YoY decline offset by +21% consumables growth, signaling clinical adoption.
- **Outpatient opportunity**: 4x reimbursement increase unlocks $1.6M/day revenue potential in new market.
- **Clinical validation**: Landmark JACC study validates Aquadex as superior to IV diuretics in heart failure.
- **Financial strength**: 81% YoY net loss reduction to $1.5M; $5.1M cash runway with no debt.

**【CEO Summary Section】**
- Q4 2024 revenue: $2.3 million (-9% YoY), driven by -21% console sales offset by +21% consumables utilization.
- Key wins: 9 new accounts in 2024, including 2 pediatric hospitals.
- Outpatient market expansion: CMS reimbursement increased 4x to $1,639/day effective Jan 2025, enabling new outpatient programs.
- Clinical evidence milestone: JACC:HF study showed Aquadex reduced heart failure events by 60% vs IV diuretics.

**【CFO Financial Commentary】**
- Gross margin improved to 58.4% (vs 54.4% YoY) due to higher consumables volumes.
- SG&A expenses down 19% to $2.9M, R&D down 42% to $0.8M, total opex -25% to $3.7M.
- Net loss narrowed to $1.5M (-81% YoY) due to cost cuts and $0.9M one-time gain.
- Cash balance: $5.1M with no debt.

**【Q&A Highlights】**
- Outpatient traction: Early-stage discussions with existing accounts to establish outpatient facilities.
- Q4 console sales: 3 units (vs 11 in Q3 2024).
- Clinical trials: Enrollment ongoing for Reverse HF and Vivian trials; timing uncertain.
- CEO search: Active with search firm; candidates identified but no timeline.

Nuwellis, Inc. (NUWE) Q4 2024 Earnings Call Transcript

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