Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — Sunshine Heart — IPO Roadshow (March 2017)
39 slides from Nuwellis's IPO roadshow presentation, Mar 29, 2017
Slide 1: Forward Looking Statement
Forward Looking Statement This presentation contains forwardlooking statements. All forwardlooking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties. Various factors could cause actual results to differ materially from these stat
Slide 2: Statement about Free Writing Prospectus
Statement about Free Writing Prospectus •This presentation highlights basic information about us and the offering. Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you should consider before investing in our company. Ex
Slide 3: Risk Factors
Risk Factors •An investment in our securities has a high degree of risk. Before you invest you should carefully consider the risks and uncertainties described below, in the Preliminary Prospectus and elsewhere in our periodic and other reports filed with the U.S. Securities and Exchange Commission,
Slide 4: Aquadex Business Overview
Aquadex Business Overview Business and Product Overview Sunshine Heart provides Aquadex and its Aquapheresis technology, a form of ultrafiltration to reduce fluids in patients, particularly when diuretics are not effective. Acquired from Baxter in August 2016. FDA 510(k) market cleared and CE marked
Slide 5: Executive Leadership Team
Executive Leadership Team John Erb Chief Executive Officer, Chairman • 40+ years experience in medical devices • CE0 of 4 med-tech start-up companies • Chairman of 3 public boards • BA in Business Administration from California State University, Fullerton Megan Brandt VP of Regulatory Affairs and Qu
Slide 6: Board of Directors
Board of Directors John Erb Chief Executive Officer, Chairman • 40+ years experience in medical devices • CE0 of 4 med-tech start-up companies • Chairman of 3 public boards • BA in Business Administration from California State University, Fullerton Jon Salveson Non-Executive Member • Investment Bank
Slide 7: Board of Directors
Board of Directors John Erb Chief Executive Officer, Chairman 40+ years experience in medical devices CEO of 4 med:-tech start-up companies Chairman of 3 public boards Ain Business Administration from California State University, Fullerton Warren Watson Non-Executive Member + 35+ years of medical de
Slide 8: Indications For Use
Indications For Use The Aquadex FlexFlow® System is indicated for: • Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy • Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diureti
Slide 9: Aquapheresis Therapy
Aquapheresis Therapy •A simplified form of ultrafiltration (UF) –Removes both salt and water •Safe method to achieve euvolemia (dry weight) • Ease of Use –Highly automated setup and operation –Inpatient or outpatient settings –Peripheral or central venous access –Used often with 4:1 RN ratios in Ste
Slide 10: A Viable Option When Diuretics Fail
A Viable Option When Diuretics Fail •Aquapheresis provides complete control over rate and total volume of fluid removed •After Ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is restored¹ •Ultrafiltration effectively and safely decreases
Slide 11: Aquapheresis Removes More Salt than Diuretics Alone
Aquapheresis Removes More Salt than Diuretics Alone •Ultrafiltration removes isotonic fluid and therefore the greatest possible amount of sodium per unit of fluid withdrawn1 •No effect on serum electrolytes2 160 140 120 Sodium (mmoI/L) 80 60 40 20 0 VRA AA1RA Diuretics Ultrafiltration 1. Agostoni PG
Slide 12: Aquadex FlexFlow Console & Circuit
Aquadex FlexFlow Console & Circuit • Simple operator interface (two user settings) and tailored treatment • rate of withdrawal, 10 to 40ml/min. in 5ml increments • the desired rate of fluid removal, 10 to 500ml/hour in 10ml increments • Peripheral venous access and a transportable console (with batt
Slide 13: Venous Access Sites
Venous Access Sites Central orPeripheral Internal Jugular Vein External Jugular Vein Subclavian Vein Basilic Vein Antecubital Vein Lower Arm Vein Femoral Vein Hand Vein © 2017 Sunshine Heart, Inc.13
Slide 14: Upcoming Milestones
Upcoming Milestones •Outpatient clinical evaluation designed to decrease readmission rates and length of hospital stay while improving quality of life •A U.S. university has received FDA and IRB approval to move forward with an Investigational Device Exemption (IDE) pivotal study. The investigation
Slide 15: Upcoming Milestones
Upcoming Milestones G. SUNSHINE HEART ¢ Outpatient clinical evaluation designed to decrease readmission rates and length of hospital stay while improving quality of life ¢ AU.S. university has received FDA and IRB approval to move forward with an Investigational Device Exemption (IDE) pivotal study.
Slide 16: Actual Revenue ($,000)
Actual Revenue ($,000) •The acquisition of the Aquadex business in August 2016 coupled with management’s new business strategy has resulted in increasing revenues. Quarterly Revenue – 2015 vs. 2016 $800 $700 Thousands ($,000) $500 $543 20152016 $746 $400 $300 $200 $100 $0 $0$0 Q3Q4 © 2017 Sunshine H
Slide 17: Grow Revenue with Existing and New Customers
Grow Revenue with Existing and New Customers Growth lever Drive utilization with existing in-patient customers Capture new customers in the in-patient market Move into adjacencies (e.g., outpatient, OUS) Actions Re-build salesforce Re-institute clinical support model Develop sales tools focused on v
Slide 18: Re-engaging and Revitalizing Hospital Accounts
Re-engaging and Revitalizing Hospital Accounts •In 2016, 55 hospital accounts accounted for 80% of revenue •In Q1-17 there are 115 hospital accounts that have ordered product from Sunshine Heart •23 dormant accounts revitalized in Q1-17 ©2017 Sunshine Heart, Inc.18
Slide 19: Reimbursement - Outpatient
Reimbursement - Outpatient •CMS established a new ICD-9 code (99.78) for Aquapheresis •CPT code 36516, Physician reimbursement •Appropriate use of existing CPT 36516 - Therapeutic Apheresis with extracorporeal selective adsorption or selective filtration and plasma re-infusion; reimbursement $75.00-
Slide 20: Reimbursement - Outpatient
Reimbursement - Outpatient Gc SUNSHINE HEART ¢ CMS established a new ICD-9 code (99.78) for Aquapheresis ¢ CPT code 36516, Physician reimbursement ¢ Appropriate use of existing CPT 36516 - Therapeutic Apheresis with extracorporeal selective adsorption or selective filtration and plasma re-infusion;
Slide 21: Defining the Market Opportunity
Defining the Market Opportunity U.S. Target Inpatient Aquadex Patients Patients in Thousands 800 600 978 685 479 200 0 Congestive Heart Failure Patients Treated with Diuretics Responsive to Diuretics 186 Readmissions from Initial Diuretic Treatment Target AQS Patients Aquadex Core Market CHF resulte
Slide 22: Symptoms and Treatment of Fluid Overload
Symptoms and Treatment of Fluid Overload Increased weight gain, particularly over short period Symptoms Swelling in legs and arms Fluid in abdomen Diuretic (e.g. Lasix/Furosemide) Treatment Secondary pharmacologics Ultrafiltration Congestive Heart Failure ~ 5 million people annually in the U.S. expe
Slide 23: ADHERE Registry Gathered Nationwide Acute Decompensated Heart Failure Data
ADHERE Registry Gathered Nationwide Acute Decompensated Heart Failure Data Clinical Status: All Enrolled Discharges at Time of Discharge N = 140,841 “To shorten lengths of stay, patients are discharged too early while they still have evidence of volume overload.”¹ ADHERE Scientific Advisory Committe
Slide 24: ADHERE Registry: Weight at Discharge
ADHERE Registry: Weight at Discharge Change in Weight During Hospitalization January 2001 to April 2006 (n=96,094) 30 Enrolled Discharges (%) 20 15 10 7% 6% 5 13% 26% 27% 48% of pts discharged with less than 5 lbs lost 21% of pts discharged with weight GAIN 16% 3% 2% 0 (<-20)(-20 to -15) (-15 to -10
Slide 25: A Single Center Experience
A Single Center Experience Good Samaritan Hospital – Dayton, OH •Independent study on 67 patients who received Aquapheresis –No 30-day readmissions for volume overload 62% of patients were not readmitted after Aquapheresis therapy for 8 months –Average of 5.7L removed per patient –Length-of-Stay whe
Slide 26: Hospital Readmission Reduction
•Hospital Readmission Reduction Readmission Data Readmission Rate 30 day readmissions 22%1 6 month readmissions 44%2,3 (FY 2013) •Requires CMS to reduce payments to hospitals with excess heart failure readmissions, among other conditions •Penalty: hospitals can lose 3% of Admitted patients with Emer
Slide 27: Affordable Care Act
Affordable Care Act G SUNSHINE HEART * Hospital Readmission Reduction Program effective as of Oct 1, 2012 30 day readmissions * Requires CMS to reduce payments to hospitals with excess heart failure 6 month readmissions 449623 readmissions, among other conditions Admitted patients with Emergency Dep
Slide 28: Clinical Trials
Clinical Trials TrialOverviewConclusions and Additional Considerations SAFE: Journal of Cardiac Failure 2003; 9(3):227–31 RAPID: J Am Coll Cardiol 2005; 46(11): 2043–6 EUPHORIA: J Am Coll Cardiol 2005;46 (11):2047–51 UNLOAD: J Am Coll Cardiol 2007;49 (6):675–83 CARRESS: N Engl J Med. 2012:367:2296-2
Slide 29: Aquapheresis not recommended in lieu of diuretics
* Sunshine Heart is not recommending the use of Aquapheresis in lieu of diuretics. The Aquadex FlexFlow System is indicated f or ultrafiltration treatment of fluid overload in the event of diuretic failure. 1. Yancy CW, et al. J Am Coll Cardiol. 2013 Oct 15; 62(16): e147 – e239. 2. Lindenfeld J, et
Slide 30: Sunshine Heart US Registry Study Concept
Sunshine Heart US Registry Study Concept: Observation Unit ADHF Management ADHF/ Enrollment Obs. Unit UF Therapy 90 Day Follow-up Outpatient •High-risk patients self-identify with ADHF hospitalization •Salvageable cases diverted from Emergency Department to Observation Unit/Clinical Decision Unit fo
Slide 31: Strategic Opportunity with AAHFN
Strategic Opportunity with AAHFN American Association of Heart Failure Nurses Industry Beat Sponsored email A monthly “sponsored” email delivered from AAHFN to their distribution list of about 3,100 members. •Featured announcement of Sunshine heart transitioning order fulfillment and we are taking o
Slide 32: Capitalization / Ownership Table; Investment Considerations
Capitalization / Ownership Table Investment Considerations
Slide 33: Capitalization / Ownership Table
Capitalization / Ownership Table Note: None of the warrants contain anti-dilution protection © 2017 Sunshine Heart, Inc.33
Slide 34: Investment Considerations
Investment Considerations 2 Underpenetrated in-patient market Addressable in-patient market size from fluid overload is 500K. 3 Untouched outpatient market Outpatient market size is 300K in the U.S. alone. 1 Established customer base 4 OUS growth opportunity Opportunity to expand utilization in curr
Slide 35: Thank you
Thank you ©2017 Sunshine Heart, Inc. www.sunshineheart.com
Slide 36: Thank you
C SUNSHINE HEART Thank you
Slide 37: Fluid Overload Hospitalization
Fluid Overload Hospitalization Congestive Heart Failure Fluid RetentionPostoperative Fluid Retention Congestive heart failure is a leading cause of fluid overload hospitalizations.1 90% of these patients present with symptoms of fluid overload. 2% of all US hospital admissions are for decompensated
Slide 38: Diuretic Therapy
Diuretic Therapy What is Diuretic Therapy? Diuretics are commonly known as “water pills” – they help your body get rid of unneeded water and salt through the urine What is Failure of Diuretic Therapy? • Diuretic failure criteria is established by the clinician or institution • Examples include*: – P
Slide 39: Diuretic Therapy
0 Diuretic Therapy GS SUNSHINE HEART What is Diuretic Therapy? Diuretics are commonly known as “water pills” — they help your body get rid of unneeded water and salt through the urine What is Failure of Diuretic Therapy? ¢ Diuretic failure criteria is established by the clinician or institution ¢ Ex