Nephros, Inc. (Nasdaq: NEPH) Investor Presentation April 2020 Safe - - PowerPoint PPT Presentation

nephros inc nasdaq neph investor presentation
SMART_READER_LITE
LIVE PREVIEW

Nephros, Inc. (Nasdaq: NEPH) Investor Presentation April 2020 Safe - - PowerPoint PPT Presentation

Nephros, Inc. (Nasdaq: NEPH) Investor Presentation April 2020 Safe Harbor Statement Certain statements in this management presentation constitute forward-looking statements. Such statements include those regarding the efficacy and


slide-1
SLIDE 1

Nephros, Inc. (Nasdaq: NEPH) Investor Presentation

April 2020

slide-2
SLIDE 2

Safe Harbor Statement

Certain statements in this management presentation constitute “forward-looking statements.” Such statements include those regarding the efficacy and intended use of our technologies under development, the timelines and strategy for bringing such products to market, the availability of funding sources for continued development of such products, and other statements that are not historical facts, including statements that may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include, but are not limited to, that (i) we face significant challenges in obtaining market acceptance of

  • ur products, which could adversely affect our potential sales and revenues; (ii) product-related deaths or serious injuries or product

malfunctions could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products; (iii) we face potential liability associated with the production, marketing and sale of our products, and the expense of defending against claims of product liability could materially deplete our assets and generate negative publicity, which could impair our reputation; (iv) to the extent our products or marketing materials are found to violate any provisions of the U.S. Food, Drug and Cosmetic Act (the “FDC Act”) or any other statutes or regulations, we could be subject to enforcement actions by the U.S. Food and Drug Administration (the “FDA”) or other governmental agencies; (v) we may not be able to obtain funding if and when needed or on terms favorable to us in order to continue operations; (vi) we may not have sufficient capital to successfully implement our business plan; (vii) we may not be able to effectively market our products; (viii) we may not be able to sell our water filtration products or chronic renal failure therapy products at competitive prices or profitably; (ix) we may encounter problems with our suppliers, manufacturers and distributors; (x) we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures; (xi) we may not be able to obtain appropriate or necessary regulatory approvals to achieve our business plan; (xii) products that appeared promising to us in research or clinical trials may not demonstrate anticipated efficacy, safety

  • r cost savings in subsequent pre-clinical or clinical trials; (xiii) we may not be able to secure or enforce adequate legal protection,

including patent protection, for our products; and (xiv) we may not be able to achieve sales growth in key geographic markets. More detailed information about us and the risk factors that may affect the realization of forward-looking statements, including the forward- looking statements in this management presentation, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and our other periodic reports filed with the SEC. We urge you to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

2

slide-3
SLIDE 3

Our Vision & Mission

3

Debris Retained Product Water Delivered

The DSU-H is FDA Cleared (bacteria & virus) to aid in infection control for up to 180-days

Nephros provides innovative and superior technologies that provide safe water solutions, delivered to our customers with unparalleled quality, reliability and service.

slide-4
SLIDE 4

Nephros: Three Business Segments

4

Established and growing water filtration base business plus a recently launched pathogen detection product and potentially transformative dialysis device to be launched in 2020

Water Filtration

§ 100% of historical revenue § Recurring revenue: razor / razor blade model § High gross margins (55-60%) § Cash flow breakeven § Impressive revenue growth: 62% average growth YoY for 15 consecutive quarters § Growing end-markets: hospitals, hospitality / food service, dialysis

Leading provider of ultrafilters to protect from waterborne pathogens

Pathogen Detection (PluraPath™)

Growing Base Business New Product Line Launches

HDF Dialysis

§ $8 billion highly fragmented global market § Real-time data (results in 1 hour) § 15 different assays simultaneously § DialyPathTM and SequaPathTM in the pipeline § Targeting 2020 relaunch § Over 15% of patients on HDF in Europe Mobile qPCR water-borne pathogen detection system Enables hemodialysis machine to perform hemodiafiltration treatment

slide-5
SLIDE 5

Daron Evans, MS, MBA President & CEO

  • CFO Nile Therapeutics, Inc. (now CAPR)
  • J&J, Arthur D. Little, Booz Allen & Hamilton
  • MBA Duke, BS Chem Eng, MS Biomed Eng

Andy Astor, MBA COO & CFO

  • President/CFO, OpenSCG (acquired by AMZN)
  • Founder/CEO EnterpriseDB, VP Asurion, VP D&B, EY
  • MBA Wharton, BA Mathematics Clark University

Michael Milman VP Research & Development

  • 10+ years Nephros, 15+ years design and dev.
  • R&D engineer with Stryker
  • BS Mechanical Engineering, Lehigh University

Vashone Thomas VP Quality and Regulatory

  • Previously Integrated Dental Systems
  • 10+ years quality leadership
  • MS Pace University

Shane Sullivan VP Sales

  • Nephros 7+ years
  • 10 years Regional Manager at Thermo Scientific
  • BS Business, USC
  • Molecular genetics, pathogen detection, food safety
  • Professor of Microbiology/Epidemiology, U Nevada
  • PhD Epidemiology

Kimothy Smith VP Pathogen Detection Products Greg Lucas President, Aether/Commercial

  • Founder/Owner Biocon/Aether Water Systems
  • Executive at Gallo Wines

Monet Carnahan VP Dialysis Products

  • Expert in Dialysis Technologies
  • Renal Care Perf. Improvement at Fresenius
  • 10+ years as Registered Nurse

Management Team

5

slide-6
SLIDE 6

Water Filtration

slide-7
SLIDE 7

What Does a Nephros Ultrafilter Do?

7

§ Nephros Ultrafilters protect patients and consumers from water-borne pathogens Debris Retained Product Water Delivered

The DSU-H is FDA Cleared (bacteria & virus) to aid in infection control for up to 180-days

Actual Backwash of a Nephros Ultrafilter After 6 Months

slide-8
SLIDE 8

Nephros Ultrafilters stop all bacteria, viruses, endotoxins

Nephros Proprietary Membrane Technology

8

Nephros Ultrafilters (0.005 μm pore size) Conventional Microfilters (0.2 μm pore size)

Endotoxins Bacteria

Nephros ultrafilter pore size: 40x smaller than conventional filters

Viruses § Conventional microfilters can stop most, but not all bacteria and are insufficient in filtering viruses and endotoxins

slide-9
SLIDE 9

3 – 28x competitor

Nephros Proprietary Membrane Technology

9

Nephros filters dramatically improve performance at a smaller cost per day vs. conventional filters

§ Nephros’ proprietary membrane technology offers smallest pore size without compromising flow rate and filter life KEY FEATURES IN WATER FILTERS

Filtration

(Pore Size)

Filter Life Flow Rate

(Membrane Surface Area)

LEADING COMPETITOR* NEPHROS

0.2 μm 0.005 μm

40x Smaller Pore Size

31-62 days 90 – 360 days

2 – 3x competitor

0.3-2.8 m2 0.06-0.1 m2

* versus Pall AquaSafe

slide-10
SLIDE 10

Multiple Competitive Advantages

10

  • 1. Intended to be used to filter EPA quality drinking water; retain bacteria, viruses and

endotoxin; provide ultrapure water for patient washing and drinking; produce water suitable for wound cleaning, cleaning of equipment used in medical procedures and washing of surgeon’s hands; not intended to provide water that can be used as a substitute for USP sterile water

Pall-AquasafeTM Nephros Filters

Pore Size 200nm 5nm Filter Life Up to 31-62 days Up to 90-360 days Number / Year 6-12 Change-outs 1-4 Change-outs Flow Rate Comparable Cost per Day Comparable Regulatory Two products FDA 510(k) cleared All products FDA 510(k) cleared Sales Model Direct sales, plus partnered with Nalco Distributor model: Garrett-Callahan, Chem-Aqua, HOH, TQM, Others

DSU-H HydraGuard™ S100 SSU-H

§ Multiple competitive advantages vs. the leading competitor

slide-11
SLIDE 11

Clinics

Total Addressable Market Over $1 Billion

11

1) Based on the number of potential filtration sites in US hospitals multiplied by $2/day 2) Based on internal estimates

~6,200

U.S. Sites 15%

% of Sites w/ NEPH Filters(2)

$400M

TAM(1)

620,000 Filters

Total Filters

20%

Penetration

1.24M Beds

Beds Hospitals

50,000+ U.S. Sites <1%

% of Sites w/ NEPH Filters

$500M+

TAM

3M+ Filters

Total Filters Commercial

~6,900

U.S. Sites

~5%

% NEPH Filters

$20M

TAM

30,000 Filters

Total Filters

100%

Penetration

10,000

RO Machines Hospitals Dialysis Commercial

slide-12
SLIDE 12

12

§ Sell through leading water management service companies § Utilize national and regional distributors § Minimal direct sales § Highly leveraged, asset-light model enables low cost of sales and high margins

Sales & Distribution Strategy

slide-13
SLIDE 13

Pathogen Detection

slide-14
SLIDE 14

§ June 2017: CMS mandates all healthcare facilities have a water management plan. Mandate requires: a) Healthcare facilities must have a plan b) Plan must be enforced and water must be tested c) Must take action if pathogens are detected

  • 1. Install filters
  • 2. Chemical cleanse (chlorine, etc.)

14

Pathogen Detection: Introducing PluraPath™

Current Nephros Sales

Benefits Assays Include:

1) On-site pathogen detection (no need to ship to lab) 2) Tested by own employees (not lab technicians) 3) Real-time results (in ~1 hour) 4) 15 pathogen panel tested simultaneously with a single water sample § Legionella §

  • E. coli

§ Pseudomonas § Shigella § Salmonella § Mycobacterium § Norovirus § Rotovirus § Mycobacterium § Camylobacter

PluraPath™ Enables Testing Sales Services and Products Offered by Water Service Partners

slide-15
SLIDE 15

Pathogen Detection: Introducing PluraPath™

15

Performs 15 separate DNA/RNA assays from a 1-liter water sample in approximately 1 hour Step 1: Collect 1-liter sample into sterile bag Step 2: Concentrate test sample w/ Nephros ultrafilter Step 3: Aliquot concentrate into an 8-well PCR test strip Step 4: Initiate portable real-time thermocycler Step 5: Thermocycler runs automatically for about 30 minutes Step 6: Upload data and review report w/ Nephros Mobile App

Custom Pelican Case for Easy Portability Portable, Real-time Open Source Thermocycler

§ Nephros uses the same distributors as the filtration business to market PluraPath™ § Largely Recurring Revenue § Expecting similar margins as the filtration business

slide-16
SLIDE 16

16

Transformation from a “water filter” company to a “water solutions” company

Additional Pathogen Detection Launches

§ Nephros will use its base pathogen detection technology to launch additional detection products

DialyPath™ SequaPath™

§ Dialysis clinics much shut down when contaminated § Current standard test (limulus amebocyte lysate (“LAL”)) routinely take over 48 – 72 hours and are shipped to a central laboratory § DialyPath™ uses PluraPath™ technology and is able to test endotoxins in real-time (1 hour) § Plan to launch DialyPath™ in Q2 2020 Entry into Dialysis Pathogen Detection Reduction in time to results Provide estimate of endotoxin levels equivalent to LAL Entry into Biome Mapping Services § Ability to process 96 samples at once § Ability to recognize over 20,000 different bacteria references in one day § Will offer this product as a service § Expected launch in late 2020 Provide estimated levels of 6 gram-negative bacteria Full building biome map Provides estimated levels of ANY known bacteria

slide-17
SLIDE 17

Specialty Renal Products, Inc. (SRP)

slide-18
SLIDE 18

2nd Generation HDF System Design Goals

18

  • Enable Nephrologists to quickly and easily offer HDF treatment to patients
  • Provide low capital cost solution vs. new HD/HDF combo machines;
  • Offer Mid-Dilution HDF technology

OLpūr H2H Module: Converts standard HD Systems to Online HDF Systems HDF Assist Module: Converts standard HD Systems to Online HDF Systems 2nd Gen HDF Project Design Targets:

  • Reduce set-up/change-over time by 90%
  • Reduce space requirement by over 80%
  • Provide disposable filter and tube set
  • Improve operator ease of use
  • Reduce HDF system cost by 95%
  • Eliminate nightly maintenance
slide-19
SLIDE 19

Financials

slide-20
SLIDE 20

$1,944 $2,320 $3,809 $5,687 $10,334

54.5% 55.8% 60.2% 56.3% 59.0%

2015 2016 2017 2018 2019 Total Revenue Gross Profit Margin

Income Statement Snapshot

20

Total Revenue & Gross Profit Margin(1)

($ in Thousands)

(1)

(2)

1) 2019 Total Revenue and Gross Profit Margin are an estimate from management in a 1/6/2020 press release 2) 2019 gross profit margin is LTM as of 9/30/2019 (no gross profit margin was given for Q4 in the 1/6/2020 press release)

§ Consistent revenue growth and stable high 50%’s gross profit margin

slide-21
SLIDE 21

Income Statement Highlights

21

2019Q4 2018Q4 Variance Full Yr 2019 Full Yr 2018 Variance

Consolidated

Revenue 3,161 1,612 96% 10,334 5,687 82% Gross Margin 60% 59% +1 59% 56% +3 EBITDA (39) (692) 94% (2,783) (2,890) 4% Adjusted EBITDA 602 (256) 335% (1,010) (1,771) 43% Net Profit/(Loss) (143) (664) 78% (3,179) (3,325) 4% Net CF from Op's 365 (448) 182% (2,276) (3,662) 38% EPS (0.03) (0.10) 75% (0.45) (0.50) 9%

Water Filtration

Revenue 3,161 1,612 96% 10,334 5,687 82% Gross Margin 60% 59% +1 59% 56% +3 EBITDA 238 (300) 179% (1,253) (1,980) 37% Adjusted EBITDA 874 136 544% 506 (861) 159% Net Profit/(Loss) 134 (147) 191% (1,648) (2,417) 32% Net CF from Op's 674 8 8331% (658) (3,127) 79%

slide-22
SLIDE 22

Balance Sheet & Capitalization Highlights

22

Balance Sheet (as of 12/31/19) (Values in 000s) Cash & Equivalents at 12/31/19 $4,166 1/31/2020 Capital Raise $6,765 Debt Revolver (8.5% interest) $560 $2.5M capacity, auto renews annually Secured Note (8.0% interest) $824 Matures 4/1/2023 Net Cash: $9,547 Capitalization Table (as of 4/2/20) Closing Share Price $6.15 Shares Outstanding 9.0M Market Cap $55M Options (WAEP: $5.51) 1.0M Warrants (WAEP: $3.37) 0.4M Fully Diluted Shares 10.4M

slide-23
SLIDE 23

Appendix

slide-24
SLIDE 24

Hospital Infection Control – 510(k) Portfolio

DSU-H & SSU-H In-Line Filters (0.005 µm) HydraGuard™ & HydraGuard™ Flush (0.005 µm)

6 Month 3 Month 3 Month 6 Month 12 Month

S100 Sink & Shower Point-of-Use Filters (0.1 µm)

§ $400 million market opportunity § Recent addition of Legionella risk prevention to CMS site inspections of hospitals and long-term care facilities increases focus on infection control

24

slide-25
SLIDE 25

Commercial Markets: Food Service and Hospitality

Sediment Cartridge Carbon Block Cartridge Carbon & Scale Cartridge Scale Control Cartridge

Commercial Filtration

Sediment, Taste, Odor, & Scale Control

§ Targeted for food service and industrial customers

  • Applications include ice machines, sinks and faucets

§ $500 million market opportunity

25

slide-26
SLIDE 26

DSU-D SSU-D SSU-Mini In-Line Filters (0.005 µm) EndoPur™10” EndoPur™20” EndoPur™30” Replacement Cartridges (0.005 µm)

12 Month 12 Month 12 Month 12 Month 12 Month 12 Month

Dialysis Water – 510(k) Portfolio

§ Filter water or bi-carbonate to assist in hemodialysis § $20 million market opportunity

26

slide-27
SLIDE 27

Thank you

Nephros, Inc. 380 Lackawanna Place South Orange, NJ 07079 P: 201.343.5202 www.nephros.com

Investor Relations Contacts: Kirin Smith, President PCG Advisory ksmith@pcgadvisory.com (646) 823-8656 Andy Astor, COO & CFO Nephros, Inc. andy@nephros.com 201.345.0824

Thank You