Nephros, Inc. (Nasdaq: NEPH) Investor Presentation
April 2020
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
April 2020
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
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
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.
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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.
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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
Daron Evans, MS, MBA President & CEO
Andy Astor, MBA COO & CFO
Michael Milman VP Research & Development
Vashone Thomas VP Quality and Regulatory
Shane Sullivan VP Sales
Kimothy Smith VP Pathogen Detection Products Greg Lucas President, Aether/Commercial
Monet Carnahan VP Dialysis Products
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§ 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
Nephros Ultrafilters stop all bacteria, viruses, endotoxins
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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
3 – 28x competitor
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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
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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
Clinics
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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
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§ 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
§ 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
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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 §
§ Pseudomonas § Shigella § Salmonella § Mycobacterium § Norovirus § Rotovirus § Mycobacterium § Camylobacter
PluraPath™ Enables Testing Sales Services and Products Offered by Water Service Partners
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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
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Transformation from a “water filter” company to a “water solutions” company
§ 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
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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:
$1,944 $2,320 $3,809 $5,687 $10,334
54.5% 55.8% 60.2% 56.3% 59.0%
2015 2016 2017 2018 2019 Total Revenue Gross Profit Margin
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Total Revenue & Gross Profit Margin(1)
($ 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
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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%
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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
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
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Commercial Markets: Food Service and Hospitality
Sediment Cartridge Carbon Block Cartridge Carbon & Scale Cartridge Scale Control Cartridge
Sediment, Taste, Odor, & Scale Control
§ Targeted for food service and industrial customers
§ $500 million market opportunity
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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
§ Filter water or bi-carbonate to assist in hemodialysis § $20 million market opportunity
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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