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 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 our 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 or 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
Our Vision & Mission Nephros provides innovative and superior technologies that provide safe water solutions, delivered to our customers with unparalleled quality, reliability and service. Product Water Debris Retained Delivered The DSU-H is FDA Cleared (bacteria & virus) to aid in infection control for up to 180-days 3
Nephros: Three Business Segments Established and growing water filtration base business plus a recently launched pathogen detection product and potentially transformative dialysis device to be launched in 2020 Growing Base Business New Product Line Launches Water Filtration Pathogen Detection (PluraPath™) Leading provider of ultrafilters to protect from Mobile qPCR water-borne pathogen detection waterborne pathogens system $8 billion highly fragmented global market § § Real-time data (results in 1 hour) § 15 different assays simultaneously § 100% of historical revenue DialyPath TM and SequaPath TM in the pipeline § § Recurring revenue: razor / razor blade HDF Dialysis model Enables hemodialysis machine to § High gross margins (55-60%) perform hemodiafiltration § Cash flow breakeven treatment § Impressive revenue growth: 62% average § Targeting 2020 relaunch growth YoY for 15 consecutive quarters § Over 15% of patients on § Growing end-markets: hospitals, hospitality HDF in Europe / food service, dialysis 4
Management Team Daron Evans, MS, MBA Shane Sullivan VP Sales President & CEO • Nephros 7+ years • CFO Nile Therapeutics, Inc. (now CAPR) • 10 years Regional Manager at Thermo Scientific • J&J, Arthur D. Little, Booz Allen & Hamilton • BS Business, USC • MBA Duke, BS Chem Eng, MS Biomed Eng Andy Astor, MBA Greg Lucas COO & CFO President, Aether/Commercial • Founder/Owner Biocon/Aether Water Systems • President/CFO, OpenSCG (acquired by AMZN) • Executive at Gallo Wines • Founder/CEO EnterpriseDB, VP Asurion, VP D&B, EY • MBA Wharton, BA Mathematics Clark University Kimothy Smith Michael Milman VP Pathogen Detection Products VP Research & Development • Molecular genetics, pathogen detection, food safety • 10+ years Nephros, 15+ years design and dev. • Professor of Microbiology/Epidemiology, U Nevada • R&D engineer with Stryker • PhD Epidemiology • BS Mechanical Engineering, Lehigh University Vashone Thomas Monet Carnahan VP Quality and Regulatory VP Dialysis Products • Previously Integrated Dental Systems • Expert in Dialysis Technologies • 10+ years quality leadership • Renal Care Perf. Improvement at Fresenius • MS Pace University • 10+ years as Registered Nurse 5
Water Filtration
What Does a Nephros Ultrafilter Do? § Nephros Ultrafilters protect patients and consumers from water-borne pathogens Actual Backwash of a Nephros Ultrafilter After 6 Months Product Water Debris Retained Delivered The DSU-H is FDA Cleared (bacteria & virus) to aid in infection control for up to 180-days 7
Nephros Proprietary Membrane Technology Conventional microfilters can stop most, but not all bacteria and are insufficient in filtering viruses § and endotoxins Conventional Nephros Microfilters Ultrafilters (0.2 μm pore size) (0.005 μm pore size) Nephros Ultrafilters stop all Bacteria bacteria, viruses, endotoxins Viruses Endotoxins Nephros ultrafilter pore size: 40x smaller than conventional filters 8
Nephros Proprietary Membrane Technology Nephros’ proprietary membrane technology offers smallest pore size without compromising flow § rate and filter life KEY FEATURES IN WATER FILTERS NEPHROS LEADING COMPETITOR* Filtration 40x 0.2 μm 0.005 μm Smaller (Pore Size) Pore Size 2 – 3x Filter Life 31-62 days 90 – 360 days competitor Flow Rate 3 – 28x 0.06-0.1 m2 0.3-2.8 m2 competitor (Membrane Surface Area) Nephros filters dramatically improve performance at a smaller cost per day vs. conventional filters * versus Pall AquaSafe 9
Multiple Competitive Advantages Multiple competitive advantages vs. the leading competitor § Pall-Aquasafe TM 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 HydraGuard™ DSU-H Cost per Day Comparable Two products All products Regulatory FDA 510(k) cleared FDA 510(k) cleared Distributor model: Direct sales, plus Garrett-Callahan, Sales Model partnered with Chem-Aqua, HOH, Nalco TQM, Others S100 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 SSU-H 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 10
Total Addressable Market Over $1 Billion Hospitals TAM (1) Hospitals Beds Penetration Total Filters % of Sites w/ NEPH Filters (2) ~ 6,200 1.24M 20% 620,000 $400M 15% U.S. Sites Beds Filters Dialysis Clinics RO Machines Penetration Total Filters TAM % NEPH Filters ~ 6,900 10,000 100% 30,000 $20M ~ 5% U.S. Sites Filters Commercial Commercial Total Filters TAM % of Sites w/ NEPH Filters 50,000+ 3M+ $500M+ <1% U.S. Sites Filters 1) Based on the number of potential filtration sites in US hospitals multiplied by $2/day 2) Based on internal estimates 11
Sales & Distribution Strategy § 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 12
Pathogen Detection
Recommend
More recommend
