Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — Investor Presentation (January 2024)
50 slides from Nuwellis's investor presentation, Jan 8, 2024
Slide 1: January 2024 Investor Presentation
1 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. January 2024 Investor Presentation
Slide 2: Safe Harbor Statement
Aquadex FlexFlow® and Aquadex SmartFlow® are registered trademarks of Nuwellis, Inc. Aquadex ® is a trademark of Nuwellis, Inc. 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
Slide 3: Overview
Overview 2 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. The Problem: Fluid Overload The Market Opportunity Nuwellis Solutions Market Validation Growth Strategy Financial Snapshot Team
Slide 4: Nuwellis, Inc. Our Mission
Nuwellis, Inc. 4 Our Mission 4 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis is dedicated to transforming the lives of patients suffering from Fluid Overload through science, collaboration, and innovation.
Slide 5: The Problem
The Problem Fluid Overload presents a significant public health challenge that impacts both patient outcomes and hospital resources. 5 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 6: What is Fluid Overload?
What is Fluid Overload? Fluid Overload is an excess of fluid in the bloodstream, vital organs and interstitial space that results in an array of patient symptoms Tiredness Shortness of breath 5 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Pulmonary edema (excess fluid
Slide 7: Three patient categories grapple with the impact of Fluid Overload
The market faces an urgent challenge as three patient categories grapple with the debilitating impact of Fluid Overload across multiple hospital specialty units Fluid Overload is the leading cause of hospital readmission post 30 days following cardiac surgery2 1. Costanzo MR, et al. JACC. 2017 May 1
Slide 8: The Healthcare Burden of Heart Failure/Fluid Overload
6.5 million US adults with Heart Failure and 40-45% will die within five years of their diagnosis6 With Fluid Overload as the leading cause of HF hospitalization, it also presents a considerable economic burden on hospitals 10 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, I
Slide 9: Cardiac surgery patients requiring readmission
Nearly 1 of 5 patients who undergo cardiac surgery require readmission Source: Iribarne A, et al. Ann Thorac Surg. 2014 Oct; 98(4): 1274-80. 1. Vaara ST et al. Crit Care.2012; 16: 1-11. 2. Pradeep, A. et al. HSR Proc IC and Car An. 2010 Mar; 2(4): 287-296. 3. Costanzo MR, et al. J Am Coll Cardiol. 2
Slide 10: Pediatric patients with Fluid Overload face increased mortality
Pediatric patients that experience Fluid Overload are vulnerable and have an increased mortality rate 1. Sutherland SM, et al. American Journal of Kidney Diseases, vol. 55, no. 2, pp. 316‐325, February 2010. 2. Gillespie RS, et al. Pediatric Nephrology, vol. 19, no. 12, pp. 1394‐1399, December 2004.
Slide 11: Diuretics have significant limitations leaving a gap in clinical care
Diuretics, the current standard of care, have significant limitations leaving a gap in clinical care 1. Costanzo MR, et al. JACC. 2017;69(19)2428‐2445. 2. Felker MG & Mentz RJ. JACC. 2012;59(24):2145‐53. 3. Al‐Naher et al. Br J Clin Pharmacol. 2018 Jan; 84(1): 5–17. 4. Butler J et al. Am Heart J. 20
Slide 12: $2B+ Addressable Market Opportunity
$2B+ Addressable Market Opportunity Across our three strategic patient categories, we have an enormous opportunity to improve outcomes for Fluid Overload patients across multiple hospital specialty units. 11 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 13: Large and expanding addressable market
See Appendix. Approved for use in pediatric patients weighing 20 kg or more. With a large and expanding addressable market, Nuwellis stands at the forefront of a transformative healthcare opportunity Outpatient market opportunity adds $0.5B+ to addressable market (heart failure and advanced liver di
Slide 14: Near-term and mid to long-term opportunities
Near-term opportunities (U.S.) Mid to Long-term opportunities (U.S.) In addition to the ongoing pediatric and HF segments, we will expand our use cases to address new critical care needs 1. Derived from: https://www.grandviewresearch.com/industry‐analysis/coronary‐artery‐bypass‐graft‐cabg‐market and
Slide 15: Differentiated Solutions
Differentiated Solutions Nuwellis has been in the business of fluid management since 2016, and we’re only getting started. 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 16: Robust foundation: collaborations, patents, products
We have strategically built a robust foundation, positioning the company to effectively address a significant market opportunity Collaborations Patent Portfolio Products Console Circuit Peripheral Access Accuracy & Safety Guided Therapy Robust clinical foundation reinforces strategic technology expa
Slide 17: Our hero therapy: Aquadex
Our hero therapy: 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Aquadex® A clinically superior solution for Fluid Overload The only device of its kind in the market
Slide 18: Aquadex: proven and predictable solution for Fluid Overload
Aquadex A proven and predictable solution for Fluid Overload. Reintroduced in 2016 An estimated 25,700 patients treated across all three of our customer categories9 From proprietary technology to unmatched advantages in Fluid Overload therapy, Aquadex has the potential to be the standard of care Pro
Slide 19: How the Aquadex system works
Filtered blood returns to the patient via the infusion line 5 The blood is pushed through the filter by the blood pump (0‐40 ml per minute) 2 The ultrafiltration pump withdraws fluid across filter membrane using negative pressure Hematocrit sensor monitors preset hematocrit limits 3 Ultrafiltration
Slide 20: Aquadex is the only device that gently and predictably removes fluid
While the competitive landscape does address Fluid Overload, Aquadex is the only device in the market that gently and predictably removes fluid Potential for more timely/effective treatment (UF) with Aquadex More flexible and predictable treatment (UF) with Aquadex Draw less blood, more predictably
Slide 21: Pediatric revenue growth and outcomes
$1.1 $1.8 $2.1 $2.7 2019 2020 2021 2022 Pediatric Revenue ($M) Received 510(k) and launched commercially in Q1 2020. We’ve seen a steady increase in our pediatric business, providing patients with high mortality an opportunity at life1 1. Source: Menon S, et al. CJSN, 2019; 14: 1432‐40. Aquadex is c
Slide 22: Coming soon: Vivian
Coming soon: 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Vivian™ Our pediatric solution On track for H1 2025 launch
Slide 23: Introducing Vivian pediatric CRRT system
1. Sutherland SM, et al. American Journal of Kidney Diseases, vol. 55, no. 2, pp. 316‐325, February 2010, 2. Gillespie RS, et al. Pediatric Nephrology, vol. 19, no. 12, pp. 1394‐1399, December 2004., 3. Menon S, et al. CJSAN, vol 14, October 2019. Introducing Vivian™ Launch best‐in‐class pediatric C
Slide 24: Novel technology with a strong IP portfolio
External Pump Detection Hemolysis/ Blood Leak Detector Accounting for Density Auto Clamp 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Transport Mode Self‐loading/ Self‐emptying Bags Open vs. Closed Loop Filter Clotting Prevention Source Line Connection Peripheral F
Slide 25: Strategic Collaborations
Strategic Collaborations Our collaborations with DaVita and SeaStar are expanding market access, bolstering technology offerings, and accelerating Nuwellis growth trajectory. 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 26: DaVita pilot to commercialization
DaVita pilot to commercialization 900+ hospital partnerships1 2,500+ clinic1 6,500+ employees1 In June of 2023, we launched a supply and collaboration agreement with DaVita to expand the access of Aquadex therapy for Fluid Overload patients Collaboration Strategy 11.6B in revenue in 20221 1. Used wi
Slide 27: SeaStar Distribution and Licensing Agreement
SeaStar Distribution and Licensing Agreement Launch market‐first SCD‐PED device (2024) Offer new product to existing Nuwellis pediatric customers Develop relationships at new pediatric accounts to support Vivian launch in 2025 Explore Nuwellis manufacturing viability for SCD Strengthen Nuwellis pedi
Slide 28: Market Validation
Market Validation Real‐world testimonials and clinical studies provide meaningful validation for Nuwellis' products. 14 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 29: Abington Hospital real-world ultrafiltration results
Abington Hospital Jefferson Health Retrospective, single center analysis 334 consecutive acutely decompensated heart failure patients Cohort of patients in study were sicker than those in other clinical trials Treated with adjustable‐rate UF using Aquadex Weight loss due to fluid removal Unchanged k
Slide 30: Ultrafiltration as an option to overcome shortcomings of diuretics
“Extracorporeal ultrafiltration has emerged as an option to overcome shortcomings of diuretics” Predictable, adjustable, and more efficient fluid removal with ultrafiltration compared to diuretics Applicability in other clinical settings, such as cardiac surgery, burn and other specialty units Poten
Slide 31: REVERSE-HF Clinical Study with Aquadex
With over 16 sites and 80+ patients enrolled, we are in the midst of executing our REVERSE-HF Clinical Study with Aquadex Planning + Enrollment Execution Analysis + Publication Protocol design based on AVOID‐HF trial Target 20 sites Goal; enroll 372 patients by end of 2024 30 | FOR INVESTOR PURPOSES
Slide 32: Growth Strategy
Growth Strategy We aim to achieve sustainable expansion and market leadership through strategic growth plans and tactics. 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 33: Four key growth efforts
Our strategic growth plan emphasizes four key efforts Grow Utilization increase the number of circuits per console Grow Penetration increase the number of consoles per hospital Grow number of New Accounts Initiate New Indications 1 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuw
Slide 34: Tactics aligned to growth plan for 2024 to 2026
We will implement tactics aligned to our growth plan to drive revenue for 2024 to 2026, focusing on sales and marketing efforts Execute Strategies CV Surgery / CC / HF / Peds Physical presence and productive days readmission Leverage Proforma and Evidence to drive earlier intervention for diuretic r
Slide 35: Financial Snapshot
Financial Snapshot Nuwellis forecasts a financially robust future, aligning our funding ask with our strategic growth plan. 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 36: Annual revenue and cash position
With a track record of consistent financial success, we're confident that our growth strategy will lead to meaningful revenue expansion Annual Revenue ($000) $5,511 $4,998 $8,543 $7,921 $7,441 2018 2019 2020 2021 2022 CASH $4.9 million as of Sept 30, 2023 NO DEBT 30 | FOR INVESTOR PURPOSES ONLY: NOT
Slide 37: 2023 quarterly results
Our 2023 quarterly results reflect improving operational efficiencies ($000) $3,000 $2,500 $2,000 $1,500 $1,000 $500 $‐ Q1 2023 Q2 2023 Q3 2023 Revenue $8,000 $7,000 $6,000 $5,000 $4,000 $3,000 $2,000 Q1 2023 Q2 2023 Q3 2023 Operating Expense $‐ $(1,000) $(2,000) $(3,000) $(4,000) $(5,000) $(6,000)
Slide 38: Key milestones 2023-2025E
Enroll 80th patient in REVERSE‐HF clinical trial Execute DaVita Supply & Collaboration agreement FDA 510(k) clearance of 12cm dual‐lumen length catheter (dELC) Anticipated IDE approval for Vivian™ Commercial introduction of SCD for pediatric AKI following HDE approval (pending) Completion of DaVita
Slide 39: Team
Team Led by industry veterans, our team is well positioned to grow Nuwellis to meet the market need. 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 40: Diverse leadership team with extensive industry experience
Our diverse leadership team boasts extensive industry experience and a successful history of commercialization Seasoned Leadership: Over 200 years' collective experience in clinical practice and the medical device industry, with significant tenures at industry leaders such as Medtronic, Boston Scien
Slide 41: Investment Overview
Investment Overview Nuwellis is committed to making Aquadex the standard of care for fluid management. 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 42: Investment Highlights
Investment Highlights 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. $2B+ TAM Positive ROI Clinical Evidence Scalable Consumables Commercial Infrastructure Product Pipeline Leadership Team $2B+ and growing addressable market in critical need Attractive clinical + eco
Slide 43: Thank you!
Thank you! 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 44: Appendix
Appendix 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc.
Slide 45: History of Nuwellis: from restart to growth
History of Nuwellis: from restart to growth ACT I 2017‐2019 ACT III 2022‐2023 ACT IV 2024‐2026 Establish Company Vision, Direction, Strategy Set the Stage for Faster Growth Execute Repurchased assets from Baxter and transferred manufacturing to Eden Prairie Committed the organization to the Vision:
Slide 46: Company history
Company history 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. Incorporated in Delaware on August 22, 2002 In January 2010, Gambro, a Denver‐based medical device company, purchased CHF Solutions In September 2013, Baxter International completed its acquisition of Gam
Slide 47: Change practice guidelines to ultrafiltration
1. Pinney S et al Poster presented HFSA Annual Meeting 2022. 2. Haas D et al. Ten year real world experience with ultrafiltration for the management of acute decompensated heart failure. American Heart Journal, 2022. 3. Beckles DL et al. The Use of Simple Ultrafiltration Technology as a Fluid Manage
Slide 48: Selling strategy & account targeting tools
Selling strategy & account targeting tools GOAL: Increase total number of active accounts & drive utilization 1. Top 10 Accounts: Maintain 3. Identify: New Accounts 2. 11-30 Accounts: Pull-through Use Top 10 Account Analysis to plan support activities to ensure these accounts maintain current levels
Slide 49: REVERSE-HF Activated Study Sites & Enrollment
REVERSE-HF Activated Study Sites & Enrollment Site Activation Date Northwell Health, Lennox Hill Hospital 20 May 2022 Abington Memorial Hospital 11 Aug 2022 University of California, San Francisco (UCSF) 06 Sep 2022 BayCare Healthcare Systems (Morton Plant) 13 Sep 2022 San Diego Cardiac Center 02 No
Slide 50: Market size sources
Market size sources 30 | FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2024 Nuwellis, Inc. 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