UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 9, 2021
(Exact Name of Registrant as Specified in its Charter)
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No.
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(State or Other Jurisdiction of Incorporation or Organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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, , 55344
(Address of Principal Executive Offices) (Zip Code)
(952 ) 345-4200
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 |
Regulation FD Disclosure.
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On September 9, 2021, Nuwellis Inc. (the “Company”) posted on its website an updated slide presentation, which is attached as Exhibit 99.1 to this
Current Report on Form 8-K and is incorporated herein by reference. Representatives of the Company will use the presentation in various meetings with investors, analysts and other parties from time to time. Within the presentation, the Company
provided the following update regarding the COVID-19 Delta variant: “COVID Delta variant is limiting access and procedural volumes in some locations; this could adversely impact the Company’s sequential growth.”
The Company also provided an update on the implementation of its strategy, including market development for the pediatric segment and heart failure patients in an
outpatient setting.
In accordance with General Instruction B.2 of Form 8-K, the information included in this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to
Item 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
| Item 9.01 |
Financial Statements and Exhibits.
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| (d) |
Exhibits
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Exhibit No.
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Description
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Nuwellis, Inc. Investor Presentation September 2021
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Cover Page Interactive Data File (embedded within the XBRL document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Date: September 9, 2021
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NUWELLIS, INC.
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By:
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/s/ Nestor Jaramillo
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Name:
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Nestor Jaramillo
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Title:
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President and Chief Executive Officer
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Exhibit 99.1
S e p t e m b e r 2 0 2 1 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021
Nuwellis, Inc. 1
Forward Looking StatementThis presentation contains forward‐looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities and Exchange Act, as amended regarding our plans, expectations, beliefs, estimates, goals and outlook for the future that are intended to be
covered by the Private Securities Litigation Reform Act of 1995. Except for statements of historical fact, all forward‐looking statements are management’s present expectations and are not guarantees of future events and are subject to a
number of known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from those expressed in, or implied by, such forward-looking statements. In some cases, you can identify
forward-looking statements by terminology such as “may,” “will,” “could,” “would,” “should,” “plan,” “predict,” “potential,” “project,” “promising,” “expect,” “estimate,” “anticipate,” “intend,” “goal,” “strategy,” “milestone,” and similar
expressions and variations thereof. Various factors could cause actual results to differ materially from these statements including our ability to execute on our commercial strategy and to grow our Aquadex® business, the possibility that we
may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and
commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our expectations regarding anticipated synergies with and
benefits of the Aquadex business, our business strategy, market size, potential growth opportunities and the other risks set forth under the caption “Risk Factors” and elsewhere in our periodic and other reports filed with the U.S.
Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10‐K for the fiscal year ended December 31, 2020 and subsequent reports. We are providing this information as of the date of this presentation, and we undertake
no obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise.Although the Company believes that the forward‐looking statements are reasonable and based on
information currently available, it can give no assurances that the Company’s expectations are correct. All forward- looking statements are expressly qualified in their entirety by this cautionary statement.Financial and Statistical
DataThis presentation also contains estimates and other statistical data made by independent parties and by us relating to market shares and other data about our industry. These data involve a number of assumptionsand limitations and have
not been reviewed or audited by our independent registered accounting firm. You are cautioned not to give undue weight to such estimates.TrademarksThe trademarks included herein are the property of the owners thereof and are used for
reference purposes only. Such use should not be construed as an endorsement of such products. FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 22 Safe Harbor Statement Aquadex FlexFlow® and Aquadex SmartFlow®
are registered trademarks of Nuwellis, Inc.Aquadex ® is a trademark of Nuwellis, Inc.
Risk Factors Investing in our securities includes a high degree of risk. You should consider
carefully the specific factors discussed below, together with all of the other information contained in our SEC filings. If any of the following risks actually occurs, our business, financial condition, results of operations and future
prospects would likely be materially and adversely affected. This could cause the market price of our securities to decline and could cause you to lose all or part of your investment. Risks include but are not limited to:We have a limited
history of operations and limited experience in sales and marketing, and we might be unsuccessful in increasing our sales and cannot assure you that we will ever generate substantial revenue or be profitable. We have incurred operating
losses since our inception and anticipate that we will continue to incur operating losses in the near-term.Our near-term prospects are highly dependent on revenues from a single product, the Aquadex system. We face significant challenges in
expanding market acceptance of the Aquadex system, whichcould adversely affect our potential revenues.We have limited commercial manufacturing experience and could experience difficulties in producing commercial volumes of the Aquadex
system and related components or may need to depend on third parties for manufacturing.We believe that we will need to raise additional capital to fund our operations. If additional capital is not available, we will have to delay, reduce or
cease operations.We depend upon third-party suppliers, including single-source suppliers, making us vulnerable to supply problems and price fluctuations.If we cannot develop adequate distribution, customer service and technical support
networks, then we may not be able to market and distribute the Aquadex system effectively and our sales will suffer.We may face significant risks associated with international operations, which could have a material adverse effect on
business, financial conditions and results of operations.The COVID-19 pandemic and other public health threats or outbreaks of communicable diseases could have a material adverse effect on our operations and overall financial performanceWe
are a “smaller reporting company” under federal securities laws and the company cannot be certain whether the reduced reporting requirements applicable to such companies will make the common stock less attractive to investors. FOR INVESTOR
PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 3
is dedicated to transforming the lives of patients suffering from fluid overload
through science, collaboration, and innovation. FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 44
Fluid Overload is a condition where there is too much fluid in the bloodstream, vital organs and
interstitial space Fluid overload is the leading cause of death for critically ill patients in the ICU within 90 days3In pediatric patients, fluid overload is associatedwith significant increases in mortality4-5 90% of all heart failure
hospitalizations aredue to symptoms of fluid overload 1Fluid overload is the leading cause of hospital readmission post 30 days following cardiac surgery2 # FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021
Nuwellis, Inc. 5 1. Costanzo MR, et al. JACC. 2017 May 16;69(19):2428-2445. 2. Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. 3. Vaara ST et al. Crit Care.2012; 16: 1-11. 4. Sutherland SM, et al. Am J Kidney Disease.2010; 5(2):
316-25. 5. Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99.
Diuretics:Standard of care with significant limitations >40% of heart failure patients have poor
diureticresponse1High risk of rehospitalization2Long-term use of diuretics has been associated with kidney damage2-5Diuretics provide insufficient symptom relief and are associated with worsening heart failure; increased mortality after
discharge2 1. Testani JM, et al. Circ Heart Fail. 2016;9(1):e002370. 2. Costanzo MR, et al. JACC. 2017;69(19)2428-2445. 3.Felker MG & Mentz RJ. JACC. 2012;59(24):2145-53.4. Al‐Naher et al. Br J Clin Pharmacol. 2018 Jan; 84(1): 5–17. 5.
Butler J et al. Am Heart J. 2004 Feb;147(2):331-8. FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 6
7 SIMPLE FLEXIBLE SMARTFOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021
Nuwellis, Inc. Safe and easy to use and flexible in applicationPredictably removes excess fluidNo significant changes to kidney function1Stabilizes or improves cardiac hemodynamics2-5Compared to diuretics, reduces
hospitalization per patient per year by 81%1Rehospitalizations for patients after receiving ultrafiltration withAquadex were 48% fewer than the national average at 30 days1Reduces length of hospital stay when initiated early, resulting in
average savings of $3,975 (14%)6-7 A superior solution for fluid overload Watson R et al. J Cardiac Fail. 2020; 26(10): s56. 2. Kiziltepe, U, et al. Ann Thorac Surg. 2001;71(2): 684-93. 3. Sahoo, TK, et al. Indian J Thorac Cardiovas Surg.
2007;23(2): 116-24. 4. Boga et al. Perfusion. 2000;15:143-50. 5. Onoe et al. Perfusion. 2001;16:37-42.65. 6. Costanzo MR et al.JACC. 2005; 46(11); 2457-51. 7. Costanzo, et. al., ISPOR 23rd Annual Int’l Mtg., May 19-23, 2018, Baltimore, MD,
USA The only device of its kind in the market: Saving lives, time + money
Key Milestones – Solid Progress FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION
©2021 Nuwellis, Inc. 8 K E Y M I L E S T O N E S E X P E C T E D T I M I N G FDA 510(k) clearance of: Expanded use in pediatric population (≥ 20kg)Next generation Aquadex SmartFlow® console Complete Nationwide Access to
Ultrafiltration Therapy Possible with Nuwellis and Premier, Inc. Collaboration Complete Clinical Data Release at Heart Failure Society of America (HFSA) and American College of Cardiology (ACC) Complete Receive CPT Category III code
for therapeutic ultrafiltration Complete Single-Center Experience With Ultrafiltration Immediately Following Cardiac Surgery manuscript at Baylor Scott & White- Potentially advances Aquadex therapy in the medical guidelines to
earlier in treatment pathway Q4 2021 Commence enrollment in the Heart Failure Control randomized multicenter clinical trial- To make Aquadex therapy the first line of treatment and standard of care for re-hospitalized heart failure
patients Q4 2021 10-Year Experience With Ultrafiltration for the Management of ADHF: Real World Experience at Abington Hospital- Continue building clinical evidence to support adoption by healthcare providers Q1 2022 Evaluate
synergistic product opportunities- Accelerate growth and cost efficiencies through disciplined, opportunistic corporate development 2022
$900M Market H E A R TF A I L U R E $150M Market P E D I A T R I C $950M Market C R
I T I C A L C A R E TREATING THE MOST VULNERABLEFrom children1 to the elderly, our therapy is critical to improving care and outcomes FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 9 $2B 1. Approved
for use in pediatric patients weighing 20 kg or more. Aquadex SmartFlow:A novel treatment targeting growing underserved addressable market segments
Providing Pediatric Patients with High Mortality Risk an Opportunity at Life (1) Attributes Group
1: <10kg Group 2: 10-20kg Group 3: >20kg # of Patients N=72 N=13 N=34 Primary disease 43% kidney29% cardiac 54% kidney31% other 38% kidney28% cardiac Survival at end oftreatment (Aquadex) 43 (60%) 13 (100%) 33
(97%) Group 1 patients traditionally do not receive any kind of therapy1. Source: Menon S, et al. CJSN, 2019; 14: 1432-40. Aquadex is currently approved for use in pediatric patients weighing 20 kg or more. FOR INVESTOR PURPOSES ONLY:
NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 10
Growing Pediatric BusinessIn five quarters, we have more than doubled the number of active and
pipeline pediatric accounts Q1 2020 Q2 2021 10 24 29 45 34 74 # o f P e d i a t r i c A c c o u n t s > 100%increase in # of accts Active Pipeline Received 510(k) 11FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT
PROMOTION ©2021 Nuwellis, Inc. FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 11 in February 2020 and launched commercially in March 2020.
Aquadex SmartFlow® simply & predictablyremoves excess fluid post cardiac
surgery Additional fluid added to compensate for blood flowing through heart lung machine1 Immediately removing fluid post-surgeryReduces time to beextubated 2,3Shortens time in post op care and ICU length of stay3,4Improves
outcomes2-5 520KPatients/Year FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 12 DeVore A et al. Curr Treat Opts Cardiovasc Med. 2014; 16(2): 283Bundgaard-Nielsen M, et al. Acta Anaesthesiol Scand 2009;
53:843-851.Wiedemann HP, et al. N Engl J Med. 2006, 354:2564-75.Stein, A. et al. Critical Care. 2012;16(R99): 1-9.Miller TE et al. Can J Anesthes. 2015; 62: 158-68.
Fluid Overload is associatedwith greater mortality1 90 - d a y m o r t a l i t y b yi n t r a v e
n o u s f l u i d m e d i a n1.000Survival rates with No Excess Fluid0.975 0.950 0.925 0.900 Survival rates with Excess Fluid IVF <= Median IVF > Median0 10 20 30 40 50 60 70 80 90Survival (days) Excess fluid post- cardiac
surgery leads tothree-fold increasein mortality at 90 daysBSW manuscript may indicate clinically relevant improvement in outcomes 1. Pradeep, A. et al. HSR Proc IC and Car An. 2010 Mar; 2(4): 287-296FOR INVESTOR PURPOSES ONLY: NOT FOR
PRODUCT PROMOTION ©2021 Nuwellis, Inc. Source: Pradeep, A. et al. HSR Proc IC and Car An. 2010 Mar; 2(4): 287-296 13
HF HOSPITALIZATIONS 10-Year Real-World Experiencewith Ultrafiltration1 A B I N G TO N H O S P I
TA LJ E F F E R S O N H E A LT HRetrospective, single center analysis335 consecutive acutely decompensated heart failure patientsTreated with adjustable-rate UF using AquadexFluid removed weight lossUnchanged kidney function Average 2.14
hospitalizations Yearbefore Aquadex Ultrafiltration 1 Year After Aquadex ultrafiltrationAverage 0.4 hospitalizations 14.9% at 90 days27.3% at 1 year 24% at 30 days250% at 6 months HOSPITAL READMISSIONSNATIONAL AVERAGE12.4% at 30
days 1.Watson R et al. J Cardiac Fail. 2020; 26(10): s56. 2. Costanzo MR, et al. JACC. 2017 May 16;69(19):2428-2445 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 14 Significant quality of life
improvement for the patients and savings to the healthcare system and to the individual hospitals
HospitalsHospitals actively trying to reduce economic burden of heart failure (HF)Reduced patient
readmissions within 30- days may help decrease costly CMS penalties9Early intervention may help decrease patient hospital length of stay (LOS)5o Most US hospitals lose money on HF admissions: average LOS is ~5 days 6, while DRG payments
often cover ≤ 4 days7 NuwellisGreater cumulative impact on outcomes through earlier intervention on healthier patientsIncreased revenue by treating more patientsUniquely positioned to deliver outpatient therapy with peripheral venous
access PatientsImproved patient QoL:Earlier resolution when diuretic therapy cannot relieve congestion patient feels better faster1,2Reduce hospitalizations through proactive fluid management (rate per patient per year decreased by
81%)3Readmission avoidance1-3Reduced financial burden to patient and family4 Why Outpatient setting is attractive market? US HealthcareSystemConcern throughout the US healthcare system regarding the growing economic burden of HF
treatment.6, 8HF treatment is Medicare’slargest expenditure9CMS controlling HF spending through the Hospital Readmission Reduction Program focused on 30-day readmissions9o Readmissions after UF treatment with Aquadex was 48% less than nat’l
average at 30 days5 1. Costanzo MR et al. JACC. 2007; 48: 467-83. 2. Stamper J, Rawal A, & Jefferies. JACC. 2021; 77(18): 734. 3. Watson R & Hummell M. et al. HFSA poster session. 2020. 4. Costanzo MR, et al. J Med Econ. 2019;
22(6): 6, 577–583. 5. Costanzo MR et al. JACC. 2005; 46(11):2047-51. 6. Rizzo JA et al. 2013. Value in Health. https://www.valueinhealthjournal.com/action/showPdf?pii=S1098-3015%2813%2901533-7 7. Premier Applied Sciences Data 2021. 8.
Samsky MD et al. JAMA Cardiol. 2019; 4(5): 444-453. 9. www.cms.gov FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 15
Financial Metrics Quarterly Revenue$ in 000s 2 0 2 1 g r o w t h c o n s i d e r a t i o n
sExpand into new pediatric accountsIncrease utilization among existing pediatric accountsIncrease utilization to treat non-COVID 19 critically illpatients in ICUMaturing sales organization, strategy and structureCOVID Delta variant is
limiting access and procedural volumes in some locations; this could adversely impact the Company’s sequential growth C a s h$24.0M as of June 30, 2021 35% increase Y/Y31% increase Q/Q2,508 1,630 FOR INVESTOR PURPOSES ONLY: NOT FOR
PRODUCT PROMOTION ©2021 Nuwellis, Inc. 1166 1,863 1,904 2,044 1,918 Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21
FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 17 Investment
Highlights Attractive capital equipment + consumables revenue growth model$2 billion addressable market: pediatrics, critical care and heart failureLeveraging commercial infrastructure to rapidly penetrate pediatric and critical care
segments while maintaining presence in heart failureOptimizing therapy through differentiated product development, including dedicated pediatric device and diagnostics to guide therapyDemonstrating therapeutic value through increased
clinical evidenceAdvocating for medical-society guidelines and improved provider reimbursement, including payment for treating patients in the outpatient setting FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc.
Capitalization Table Common Shares Outstanding (Nasdaq:
NUWE) 6,532,018 Series F Convertible Preferred (1) 23,114 Warrants from 2020 Financings (2) 1,479,040 Other warrants (3) 152,766 Options 812,561 Fully Diluted Shares 8,999,499 NO D E B T C A S H$24.0 million (as of June 30,
2021) C a p i t a l i z a t i o n a s o f J u n e 3 0 , 2 0 2 1 NotesFrom November 2017 offering. Convertible at $5.50 per share, anti-dilution rights to next offering price.Consists of 130,170 warrants at $5.50, price protection down to
$1.65, exp. 1/25; 138,715 warrants at $11.18, exp. 9/25; 85,506 warrants at $11.15, exp. 10/25; 59,966 warrants at $12.30, exp. 11/25; 1,064,683 at $13.50, exp. 8/25.Consists of 19,196 warrants at $42.30, exp. 4/25; 40,638 warrants at
$29.83, exp. 11/24; and 92,932 warrantsexercisable at a weighted average exercise price of $360.96, expiring Feb 2022-Nov 2024. No anti-dilution rights. FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 18
Thank You FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. 19