Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — Q1 2025 Earnings Presentation
25 slides from Nuwellis's earnings presentation, May 13, 2025
Slide 1: Making Aquadex the Standard of Care for Fluid Management
Making Aquadex the Standard of Care for Fluid Management Investor Presentation May 2025 1 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2025 Nuwellis, Inc.
Slide 2: Safe Harbor Statement
Safe Harbor Statement Financial and Statistical Data This presentation also contains estimates and other statistical data made by independent parties and by us relating to market shares and other data about Forward Looking Statement our industry. These data involve a number of assumptions and limita
Slide 3: Our Mission
Our Mission Nuwellis is dedicated to transforming the lives of patients suffering from Fluid Overload through science, collaboration, and innovation. 3 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2025 Nuwellis, Inc. 3
Slide 4: Nuwellis is at a Strategic Inflection Point
Nuwellis is at a Strategic Inflection Point Bridging Specialties in Care Critical Care + Pediatrics Expanding Outpatient Care Delivery • Now ~80% of our business, • Motivated by a 4x increase in • Strengthening integration between reflecting strong demand. reimbursement rates, enhancing cardiology a
Slide 5: Significant Growth in Critical Care and Pediatrics Drives Strategic Focus
Significant Growth in Critical Care and Pediatrics Drives Strategic Focus As critical care and pediatrics now constitute ~80% of our sales, Nuwellis is realigning its resources towards the Critical Care and Pediatrics customer categories to capitalize on their growth. TOTAL U.S. PRODUCT REVENUE2 $3.
Slide 6: Introducing New Outpatient Reimbursement Rate for Aquadex
Introducing New Outpatient Reimbursement Rate for Aquadex With the reassignment of CPT 0692T, daily reimbursement rates have significantly increased, making Aquadex a sustainable option for hospitals to provide essential outpatient care without financial loss. $1,800 $1,639 $1,600 4x Higher $1,400 R
Slide 7: Financial Incentive for Hospitals to Use Aquadex in Outpatient Setting
Financial Incentive for Hospitals to Use Aquadex in Outpatient Setting Our outpatient customer category boasts a strong pipeline, indicating significant, near-term revenue opportunities. Increased Reimbursement Recurring Revenue Cost Avoidance With reimbursements now up to $1,639, outpatient Aquadex
Slide 8: The Updated Reimbursement Opportunity is a Win-Win Across the Entire Healthcare Ecosystem
The Updated Reimbursement Opportunity is a Win-Win Across the Entire Healthcare Ecosystem PATIENTS HOSPITALS Gives easier access to improved, preventative care, Financially Viable Therapy enhancing overall quality of life. PAYOR NUWELLIS Promotes cost efficiency, reducing expenses across Drives busi
Slide 9: Expanding Opportunities Across Critical Customer Categories
Expanding Opportunities Across Critical Customer Categories Leveraging growth in critical care, pediatrics, and outpatient settings to maximize market reach and impact. $2.53B+ TAM Critical Care Heart Failure Pediatrics $900M Market4 $1B Market4 $130M Market4 Outpatient Treatment $773M Market4 4: Se
Slide 10: We Are Progressing Toward Key Milestones In The REVERSE-HF Trial
We Are Progressing Toward Key Milestones In The REVERSE-HF Trial Insights from the REVERSE-HF Trial will support outpatient and critical care strategies by validating the effectiveness of Aquadex therapy in reducing heart failure events. Q1 Study Completion First Patient February 150th Patient ANTIC
Slide 11: Our Strategic Growth Plan Emphasizes Four Key Efforts
Our Strategic Growth Plan Emphasizes Four Key Efforts We’ve structured our sales and marketing team to ensure seamless execution 1 Cardiac Surgery Business Strategic Focus 2 Accelerate Market Penetration in Outpatient 3 Product Portfolio Expansion via Partnerships 4 Continue Development of Pediatric
Slide 12: Strategic Focus on Critical Care for 2025
Strategic Focus on Critical Care for 2025 Strategically optimizing the patient journey with targeted fluid management solutions that enhance outcomes at every stage. Alternative to Pre-Op Post-Op Recovery Conventional Optimization Methods Optimizes pre-surgery fluid levels, reducing Rapidly corrects
Slide 13: There is a critical and widespread incidence of acute kidney injury among cardiac surgery patients
There is a critical and widespread incidence of acute kidney injury among cardiac surgery patients As many as 80% of cardiac surgery patients may have stage 1 or greater CSA-AKI according to the strict, consensus-based guidelines AKI Prevalence in published by the Kidney Disease Improving Global Out
Slide 14: Aquadex: Our Solution
Our Solution Aquadex ® A clinically superior solution for Fluid Overload7 The only device of its kind in the market 7: Pinney, S et. al., J AM Coll Cardiol HF, 2025, ISSN 2213-1779 https://doi.org/10.1016/j.jchf.2024.11.018 14 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2025 Nuwellis, Inc
Slide 15: How the Aquadex system works
How the Aquadex system works Predictable and precise fluid removal 1 Blood is taken from 2 3 The blood is pushed The ultrafiltration the patient via the through the filter by pump withdraws withdrawal line using the blood pump fluid across the filter proprietary catheter membrane using technology (0
Slide 16: Vivian: Our pediatric solution
Vivian Our pediatric solution 16 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2025 Nuwellis, Inc.
Slide 17: Our Growth and Success in Pediatrics Drive the Development of a Dedicated Device
Our Growth and Success in Pediatrics Drive the Development of a Dedicated Device for High-Risk Conditions Improved patient survival at end of treatment Group 1: Group 2: 10- Group 3: Attributes8 <10kg 20kg >20kg # of Patients N = 72 N = 13 N = 34 4-10 circuits/pts 54% kidney 43% kidney 38% kidney Pr
Slide 18: Reappraisal of AVOID-HF Published in JACC: HF in 2025
Reappraisal of AVOID-HF Published in JACC: HF in 2025 Demonstrated Aquadex Significantly Reduces Heart Failure Hospitalizations9 Reassessed clinical benefit of ultrafiltration versus intravenous diuretics in 224 hospitalized heart failure patients. Key Reappraisal Conclusions: • Reanalysis confirmed
Slide 19: We Are Confident That Our Growth Strategy Will Lead To Meaningful Revenue Expansion
We Are Confident That Our Growth Strategy Will Lead To Meaningful Revenue Expansion And Improved Cash Flow U.S. TOTAL PRODUCT REVENUE CASH $2.6 million as of Heart Failure Critical Care Pediatrics March 31, 2025 19% 23% 27% 30% 35% 37% 39% 33% 35% NO DEBT 42% 45% 42% 40% 44% 48% 41% 31% 24% 23% 23%
Slide 20: Capitalization Overview
Capitalization Overview As of March 31, 2025 Common Equivalents Common Stock 4,373,968 Preferred Stock 69,039 Warrants (weighted avg. exercise price: $5.49) 5,325,058 Options (weighted avg. exercise price: $524.67) 3,385 Fully Diluted 9,771,450 20 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTIO
Slide 21: Nuwellis Leadership Team
Nuwellis Leadership Team Over 200 years of combined experience in clinical practice and the medical device industry, including major tenures at Medtronic, Boston Scientific, and Abbott/St. Jude Medical. John Erb Rob Scott Megan Cotts Neil Ayotte Interim Chief Executive Officer Chief Financial Office
Slide 22: Investment Highlights
Investment Highlights Capitalizing on strategic shifts and proven clinical outcomes to drive substantial market presence and financial success, poised for dramatic growth in 2025. Strategic Realignment Financial Growth Clinical Advancement • Focus on high-growth categories • Consistent upward trajec
Slide 23: Thank You
Thank You 23 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2025 Nuwellis, Inc.
Slide 24: Appendix
Appendix 24 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2025 Nuwellis, Inc.
Slide 25: Market size sources
Market size sources Heart Failure – Inpatient ($1B+) • Incidence of HF: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/ • Annual HF Hospitalizations: Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445 • Insufficient diuretic response: https://www.ahajournals.org/doi/10.1161/CI