Nephros, Inc.

Good day and welcome to the Nefros, Inc. Fourth Quarter 2021 Financial Results Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Kieran Smith with PCG Advisory. Please go ahead.

Good afternoon, everyone. This is Kieran Smith with PCG Advisory. Thank you all for participating in NEPHRO's fourth quarter 2021 conference call. Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements regarding the operations and future results of Nefros. I encourage you to review Nefros' filings with the Securities and Exchange Commission, including, without limitation, the company's forms 10-K and 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Factors that may affect the company's results include, but are not limited to, the impact of the COVID-19 pandemic, Nefros' ability to successfully, timely, and cost-effectively develop, seek, and obtain regulatory clearance for its products and services offerings, the rate of adoption of its products and services by hospitals and other healthcare providers, success of its commercialization efforts, and its effect on the business of existing and new regulatory requirements, and other economic and competitive factors. The content of this conference call contains time-sensitive information that is accurate only as of the date of the live call, today, February 23rd, 2022. The company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call, except as required by law. I would now like to turn the call over to NetROSA's President and Chief Executive Officer, Andy Astor. Andy, please go ahead.

Thank you, Karen, and good afternoon, everyone. With me on the call today is Wes Lobo, our Chief Commercial Officer. Some of you might recall that Wes joined Nefros a little over a year ago and happy anniversary, Wes. And I thought it would be beneficial for you all to hear what he and his teams have been working on. I will begin the call with a summary of Nefros' recent progress toward its revenue guidance of 25 to 30% growth or 13 to 13 and a half million dollars. I am pleased to report that we've had a strong start to the first few weeks of 2022. And to name a few examples, number one, we are now shipping filters on a nationally recognized quick service restaurant deal, which will add about $250,000 in revenues in 2022. We also continue to pursue several other large opportunities in the food service and beverage industries. Two. We have become a strategic supplier for two major dialysis companies. We expect these deals to add at least half a million or $500,000 in revenue over the next 12 months. Other significant dialysis customers are also in the pipeline. Three, we are making excellent progress in our pathogen detection systems group, including significant commercial discussions with at least three leading firms in the microbiological testing space. Also, as noted in our recent shareholder letter, PDS, our pathogen detection group, has achieved CDC's ELITE certification for our laboratories, which has helped establish nephros as a leading developer and manufacturer of QPCR assays for both environmental and RUO, or research use only, testing. Four, with respect to specialty renal products, or SRP, and the HDF Assist Module, we have completed our responses on 10 of the 14 topics raised by the FDA and are on schedule to resubmit for 510 clearance by the end of this quarter, Q1. Based on our high level of confidence, we have just hired an SRP Director of Commercial Operations whose job will be to manage the commercial launch of the HDF Assist Module and all aspects of the sales, marketing, logistics, and training related to the commercial launch of HDF. Five, we are planning to launch our new website and lead generation infrastructure in the next 45 to 60 days. And six, finally, our core business and hospital filtration sales remain strong, including customer retention rates exceeding 90%, and adding an average of more than one new customer site every day. We believe all of the above points are strong indicators of progress and are cause for optimism. To be clear, though, not all of these will be showing significant results in Q1 or even Q2. Building scalability will have a bigger return in the second half of 2022, and more importantly, sets us up for sustainable growth in the long run. I will say this. The Nefros leadership team is working tirelessly to deliver tangible results in the coming months to return us to the growth performance you have come to expect from Nefros, and that we all believe that we can deliver. So I'll now turn the call over to Wes Lobo, our Chief Commercial Officer, for a closer look at some of our sales and marketing activities, and then I'll return to review our financial results. Wes, please go ahead.

Thank you, Andy. Good afternoon, everyone. It's a pleasure to be joining you on today's earnings call. So over the past year, I've had the opportunity to meet our healthcare and commercial customers and partners, both virtually and in person. I've been in hospitals with our sales and service teams to see firsthand what we do and how we do it. My main learning is that we are a niche market player in infection control for healthcare, and what we do, we do extremely well. When we get in front of a potential customer, we have a very high rate of success. Our challenge has been the ability to broaden the reach of a value proposition to a wider audience. To use a sports analogy, we have a high batting average. We need more at bats. We are addressing this opportunity through three lenses, brand and marketing, business development, and customer service. First, our brand and marketing team has been working diligently over the past few months to overhaul and launch a new Nepros brand that better articulates who we are and how we help our customers. In scope, to name a few elements, is a new website, updated product and company collateral, lead generation initiatives, and more channels through which to connect with our customers. We will be publicly launching our new brand and messaging at the Granger Show next week in Orlando, and we expect to launch the new website in the next 45 to 60 days. Our goal is to make Nefros easier to find, easier to contact, and to clearly communicate our value proposition in an easy to understand and measurable way. On the business development front, We've organized around our three primary filtration segments of healthcare, dialysis, water, and commercial, as well as pathogen detection. While the pandemic has caused significant stress on the healthcare market over the past two years, the market opportunity and expected growth from favorable CMS guideline changes continue to make healthcare primary focus for nephros. Between hospitals, long-term care, and skilled nursing facilities, there are over 50,000 locations in the U.S. alone. According to the AIA consensus construction forecast, new construction and retrofit expansion spending in healthcare is expected to grow at mid-single digits in 2022 and 2023. With continued expansion of healthcare facilities and more beds being added to the addressable market, we have a lot of runway to accelerate growth and expand our share within healthcare networks through a targeted value proposition with our channel partners. For example, We can now supplement our infection control filters by providing our healthcare customers with filtration solutions to include taste, odor, scale, and more. Over the past two years, we've had nice pull-through growth of the commercial filters being sold as part of a solution with our infection control filters in healthcare. In fact, in one recent example, a California-based hospital that uses our inline infection control filters for their ice machines was unhappy with the taste of their water, so their patients and staff were using bottled water. They asked if we could help, and by supplementing their infection control filters with our carbon filters for taste and odor, they now enjoy drinking water from their dispenser and have cut down on pallets of plastic bottled water. This is one of many examples of accomplishing our goal to be a resource for science, solutions, and services to our customers. In dialysis water, we have strong OEM relationships where filters play a key role in dialysis machines delivering safe dialysis water to patients by retaining bacteria and endotoxins. We were recently qualified as a strategic supplier by a high growth dialysis company and we are working on similar strategic relationships with a handful of dialysis machine providers. We expect our dialysis water business to continue its strong growth trajectory as we work to solidify our OEM relationships. In commercial filtration, we are focused on the food service and beverage market, especially quick service restaurants or QSRs. As Andy stated earlier, We recently started shipping filters for beverage machines to a large national chain, QSR, a quarter of a million dollar opportunity. And we're working on similar opportunities with globally recognized partners and regional chains. These commercial opportunities are multi-tiered and more complex than healthcare and therefore take longer to develop. However, we believe we have a healthy pipeline and will continue to nurture and develop these opportunities. Moving from filtration to our pathogen detection business, last year, We had a nice few wins across healthcare, multifamily housing, and recreation hospitality. We grew from 30,000 in revenue in 2020 to 188,000 in 2021. And more importantly, we gained experience and feedback on our products and services from end customers, consultants, service providers, and agencies. Our industry-leading assortment of assays are applicable to many different markets and customer types. Our focus in the short term is to shore up our relationship with at least two potential testing partners as a supplier of qPCR test strips and kits. We anticipate our pathogen detection business to demonstrate sustainable growth in 2022 and to build a foundation for accelerated growth going forward. Finally, to the topic of customer service. We are well known for our industry-leading service when it comes to emergency and outbreak response business. We are working to supplement this service with a more structured approach to the full customer journey to provide a terrific customer experience and improve our customer retention rate. While our current retention rate of greater than 90% is good, we know it can be better, and each extra percent of customer retention means improved customer experience and higher revenue. As you can see, our team is working on many exciting growth opportunities, which we believe will have measurable benefits in 2022 and beyond. A year ago, I stated my enthusiasm for joining the NetPro's team and having the privilege and opportunity to tell our story. We've been working to do just that, and in the coming weeks, Our team is excited to share the story of how NEPHRO seeks to improve the human relationship with water by providing leading accessible technology and resources for advancing water safety and water quality. Thank you. And I'll turn the call over back to Andy now.

Thank you, Wes. That was great. I will now review our financial results. We reported fourth quarter net revenue of 2.8 million and 18% increase over prior year and full year revenue of 10.4 million, a 22% increase over prior year. The 10.4 million represents a revenue record, I'm sorry, a record revenue year for NEPROS, albeit by a small margin. And furthermore, we have now delivered four consecutive quarters of year-over-year growth averaging 19%. Net consolidated loss for the quarter was a million, $1 million, compared with 0.8 million in 2020, And net consolidated loss for the year was 3.9 million compared with 4.5 million in 2020. Consolidated adjusted EBITDA in the quarter was negative 0.4 million compared with negative 0.5 in 2020. And consolidated adjusted EBITDA for the year was negative 2.6 million compared with negative 3.6 million in 2020. Consolidated gross margins in the quarter were 53% compared with 56% in 2020. Consolidated gross margins for the year were 55% compared with 57% in 2020. We do continue to expect future gross margins to be in the range of 55 to 60% despite this quarter's fall to slightly under that range. Consolidated R&D expenses in the quarter were 0.5 million compared to 0.6 million in 2020. And consolidated R&D expenses for the year were 2.2 million compared with 2.8 million in 2020. Consolidated SG&A or sales general and admin expenses in the quarter were 2 million compared to 1.4 in 2020. And consolidated sales general and administrative expenses for the year were 7.7 compared with 6.5 million in 2020. Our cash balance on December 31, 2021, was $7 million, 7.0. Please refer to today's press release for more details about the calculation of adjusted EBITDA and its reconciliation to GAAP net income or loss, and additional information about our results, including our water filtration, pathogen detection, and renal products business segments will be found in our filing on Form 10-K, which we plan to file on or about March 2, 2022. That concludes the financials. I'll now make a couple of closing comments. In our last earnings call in early November, I said we were pleased with the results, but that we were not satisfied. In that call, I stated our intention to accelerate our growth trajectory by investing in scalable commercial and operational infrastructures and balancing short-term results with long-term sustainable growth. We are staying true to those objectives, and the results are beginning to show, as evidenced by the examples I listed early in this call, as well as by Wes's comments. As always, I would like to thank each of our NEFROS employees and our strategic partners for their unwavering focus on providing unsurpassed products and services to our customers, and thanks also to Our devoted investors represented on this call largely for your continued confidence and, frankly, your patience. Please continue to stay in touch. You can always reach out to me at andy.aster, A-S-T-O-R, at necros.com. This concludes our formal presentation remarks. We will now take questions from the audience. Operator or Chad, please open the call for questions. Thanks very much.

We will now begin our question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using your speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster.

Thank you.

And our first question will come from Mark Weisenberger with B. Reilly Securities. Please go ahead.

Thank you. Good afternoon. I appreciate the insight into the commercial win. I'm wondering if you could just rehash those details again. And additionally, what percent of the overall footprint does what you're currently servicing represent for this customer in aggregate? And is this kind of an initial pilot that maybe as we move through the year should expand from the stats that you talked about earlier?

Sure. Hi, Mark. What I said was, and Mark, I'm sorry, go ahead. We will add about a quarter of a million dollars in revenue in 2022. We don't have the exact numbers yet. And it is not a pilot. The testing is over, and this is a nationwide rollout. But as I've said before, both in private conversations and I think also on these calls, the market of food service and hospitality has a unit value that is much lower, or I should say a site value that's much lower than in healthcare. It's usually in the hundreds of dollars, if that, And so this is a large contract with multiple thousand locations, and that is the expected annual revenue, roughly a quarter of a million dollars, give or take.

Great. Appreciate that additional insight. You talked about kind of scalability is setting up for a bigger second half of the year. The last few years, the second half represented – about 52% of overall sales. Should we expect any deviation to that this year based on your scalability comments?

You know, it's hard to set specific numbers for what the second half of the year looks like. I don't think that what you just said was the... If I look back at 2019, for example, I think it was more like 60% in the back half of the year. So first of all, I'm not sure it's as evenly spread as your observation. But more importantly, Mark, the difference this year is not that we're saying the second half of the year will be big, will be larger because of market trends, but rather because the scalable infrastructure and the work that we're building in are expected to build over time. And so I think it is our expectation that we'll see increased acceleration through the year and also into next year.

With regards to your calendar 22 guide, I'm wondering if you could talk about the level of emergency response that you're kind of baking in, and how does that compare relative to calendar 2019? I believe the emergency response has kind of been below trend in both calendar 20 and maybe 21. I don't think Legionella outbreaks took time off as a result of COVID, so where's the primary delta relative to normalized trends or is it kind of weakness maybe in larger hospitals or long-term care facilities? I don't know. I'd love to hear your thoughts. And also, when do you think maybe you get back to normalized levels in the emergency response segment of business?

Well, emergency response was deeply, deeply depressed, close to zero in 2020, but that was not the case last year. Emergency response last year was in the normal range. We usually say that if you zoom out, it's about 15%, although it varies tremendously because it is, by definition, unpredictable. It is emergency. And we're expecting similar levels of 15-ish percent as we continue to grow and we will learn, frankly, whether or not emergency response will scale at the same rate or faster or slower as we grow because we've never been there before, so we'll have to see. But as a starting point, you know, 15% or so is about right.

Great. Appreciate it. And then just a final one for me. If you could talk about the demand resulting from recent CMS and Joint Commission guidelines, how that's progressed at the end of the year, how it's progressing thus far in 2022, and how close of an analog is the 2017 time period turning out to be thus far and going forward? Thank you.

Thank you, Mark. You know, it's a hard thing to measure. When we were in the 2017, 2018, and even 2019, in the field, there was a lot of talk about the new CMS guidelines. And for those on the call who may not be familiar with this, these are guidelines on water management plans that every healthcare institution in the country is required to follow. They started in June of 2017 with a set of guidelines, and those guidelines are being or have been tightened starting on January 1, 2022. And I would say that we're seeing the same thing. It is a big issue. Hospitals or healthcare institutions are dealing with it differently. It's more of a rising tide. You don't really notice the impact on a day-by-day basis, even though it's a hot topic. But it very much influenced our growth in the 2017 to 2019, and frankly, I expect it to continue to do the same thing in 2022 to 24. Thanks, Mark. I appreciate it. Great, thank you.

And the next question will come from Anthony Vendetti with Maxim Group. Please go ahead.

Yes, thanks. There was some static there, so I don't know if you answered this, Andy. So the new water management standard went into effect 1-1-22. Did that new standard increase interest in your products and services? And if so, is there a way to quantify to what level in terms of either the pipeline or the growth that you can attribute to that new standard?

You know, I don't have a, and I'm sorry about the noisy line, I don't have a quantification of that My experience in the 2017 to 19 timeframe was that it was more like a rising tide that more healthcare institutions were interested in water management plans, which we do not per se do, but we do the remediation that comes from water management planning. And it obviously had a very helpful impact I don't know how to quantify the specific impact of the guidelines on what we're seeing in the market. Wes, would you differ from my perspective? You're in the field a little more.

Yeah, it's a great question. I think from what I've seen so far is it's too early. I know that it did go into effect on 1-1-22. And what I've seen and what I've heard is there's a mix of healthcare facilities, right, that prior to this going into effect were already stressed in terms of manpower and coverage, whether it was maintenance, facility upkeep, you know, et cetera. So there's a combination of still education that's going on. You see a lot of, you know, whether it's through different consulting agencies and, you know, organizations who are still out there doing a lot of education as they go through with their health care communities and again working with the maintenance engineering and operations staff but we have seen you know I think Andy you mentioned it in the last earnings call we have seen facilities that we're contracting with now new new health care facilities that we're contracting with that are seeking out our product or asking about it as a result of implementing the water management plans so we are seeing and ask as a result of it. But we're also seeing that there's still a lot of questions about exactly what it means. There's still a lot of education going on. And so my view is that it's going to be a slow walk up in the first few months that we're going through right now. And the role that we play in it, and it's part of what I mentioned before about just getting more fast, the role we play in it is to just try to cast a wider net on helping the healthcare community through education on what it means, how it impacts them, and how we can help.

Okay, yeah, no, that's helpful. And then just to, that was a good caller on the restaurant contract, Andy, but just on the specialty renal products, so you've completed 10 of the 14 questions. You expect to resubmit to the FDA for the 510 by the end of 1Q22. Is that a 90-day clock that starts once you resubmit? That's one part of the question. And then the second part is you mentioned in the beginning of the call in your prepared remarks, you have in your orders or your backlog of orders, you have 500,000 from two HDF customers. Is that contingent upon this product being approved? or is that a different contract?

Oh, I wish that was the case, Anthony, but that's not. So first of all, it is a 90-day clock that restarts when we resubmit. So we're planning on resubmitting at the end of March, and we are – what we have found is that the FDA is – unpredictable and can be quite slow in its responses, but we are making headway with them, and I do believe that we will resubmit at the end of March, and I do believe that roughly 90 days later, we should be getting a response from them. What you heard in terms of the half a million dollars was for a couple of of dialysis water purification contract. In other words, we have three filtration businesses, as you'll recall. We have hospitals infection control, we have dialysis water purification, and we have our hospitality and food service business. The half a million dollars that I mentioned was in the dialysis water purification. That's completely different than the HDF business, which I talked about a little bit later.

Okay, now that clarifies it. That was very helpful. Okay, good. Okay, those are my questions. Thanks very much. I'll hop back to you.

My pleasure, Anthony. Good to hear from you.

Thank you. And the next question will come from Neil Cataldi with Blueprint Capital. Please go ahead.

Hi, guys. Thanks for the color tonight. A few of mine were already asked, but I'll just follow up on two. Regarding the QSR opportunity, could you tell us how long you were working on this? And has anything changed that might mean more of these start to hit or Does this win effectively open the door, validate your ability to capture others?

It's a great question, Neil, and good to hear your voice. If I said forever we've been working on it, would you believe me? We've been working on it for quite some time, probably over, certainly over a year, and maybe a little longer than that. And I don't think that it represents a change for, I don't think there's an industry change that caused it to happen. I do think that our persistence and our integrity and our relationship building has paid off. And we're not starting from zero in the other opportunities that we are pursuing. And as the word gets around, which it will, of our filters in several thousand locations and our ability to deliver and perform and our reputation grows, I do think that it will help us win additional business.

Okay. So I remember like two years ago you were talking about a big a big opportunity and it sounds like this is a, this is a different one and maybe, maybe that one's still out there. Could you, could you help us understand why they, why they chose to switch? Was it a cost, you know, comparison or was it some other feature? Why they chose to switch at all? Or were you, were you designed into a new machine or I don't know, is there any, Any background on why they chose you versus other competitors that have filters?

They had reasons, which I won't discuss, that they wanted to get away from their provider and vice versa. They wanted to change their filtration solution, and they went looking for products through a... So they were serviced by a company, and that company went looking for providers, found us, selected us, tested us, partnered with us, and so we were selected. So, frankly, it was not a, you know, it was not a, it was a cold selection process.

Got it, so there's a middleman partner that you have a relationship with?

There was barely a relationship there. The middleman partner knew of us, but they also knew of everybody else, and we were evaluated along with others.

Got it, great. Okay, one other question I have on the pathogen side. I think you mentioned some partners that you're working on there. Anything you can elaborate with? I imagine they're distributors of some sort, and if so, what type of hospital reach might they have?

Well, what I said was three leading firms in the microbiological testing space, and I'm not going to comment further on what or who they are, but they're not the traditional hospital distributors that we've been working with on the filtration side, even though there's also opportunities growing on that front.

Okay. All right, great. Thanks, guys. Great call tonight. Look forward to talking soon.

You too. Thanks, Neil.

Once again, if you have a question, please press star, then 1. The next question will come from Jason Hirschman with Hudson 215 Capital. Please go ahead.

Hi, Andy. Hi, Wes. How are you guys doing today? Doing great, Jason. Nice to hear your voice. Nice to hear you for voice, too. You've talked about batting averages. You've talked about getting more at bats. So I'm just going to continue the baseball talk and bring up slugging percentage and ask if there's a way to maybe perhaps, I mean, you mentioned the bundling, maybe just, you know, for one hospital, but going forward, bundle some kind of On the hospital side, is it the commercial side of the hospital and also even pathogen detection solutions to a single customer? Is that something that you can see may grow to be a bigger part of your business or a bigger opportunity going forward?

It's a great question, Jason. The answer is yes. And Wes, would you like to talk about the cross-selling opportunities?

Sure. Yeah. Yeah. Thanks for the question, Jason. So there's a natural adjacency between our pathogen detection business and our healthcare business. And as I said earlier, our, you know, the assortment of assays that we have really can go into many different vertical markets, but specifically for healthcare, this is where we play most. There's that adjacency and we've already seen success in joint calls where we're going in to speak about one and the other comes up and vice versa. And so that's part of our business development is to see sort of how much of a run we have there. You know, coming back to slugging percentage, I mean, really it's about extra base hits, right? And so, you know, in terms of dollar value, our deals, right, for the most part, save a large, you know, international QSR account that's in the multi, you know, hundreds of thousands, save that type of opportunity. Most of our deals, as Andy said before, are sort of a low dollar volume per transaction or per site. And, you know, when I say get more fast, you know, singles are great because we want to, the more we have of them, the more predictable and the more, you know, you kind of set your clock to it versus hoping for the home run. So I'll keep that analogy. So that's sort of general frame of mind, but even with pathogen detection sort of coupling it with pull-through and filtration solutions in healthcare, the actual dollar value of the transaction wouldn't necessarily be a lot higher, but certainly it's something that we not only could do but are already doing when we're going in to speak with. And that also depends on who you're speaking with as a customer target audience. And so it is something that's in the works. It is absolutely sort of within the scope of the business development work we're doing. It's a great point you're bringing up. I also wanted to level set that. you know, doing that joint sale doesn't necessarily take it from a, and I'm sort of using hypotheticals here, you know, a hundred dollars sale to a $500 sale.

Sure. Sure. And I understand that. And I appreciate the additional color. I just also, I would think perhaps it would, it would aid some of the customer retention, the more things you get into a particular customer, of course, but, but we'll see, you know, great quarter and looking forward to you hitting your guidance this year and we'll keep our fingers crossed that we're, we're, we're, we're done with the pandemics part of the pandemic at least.

And thank you. Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Andy Astor for any closing remarks.

Thanks very much, Chad. And thanks, uh, Kieran and Wes for, uh, for being on the call with me today and sharing the mic. Um, And thanks to everybody for dialing in. We had a really good showing today. It's been a tough few months. You know, we've – sorry, 2020 and 2021, while we grew out of the pandemic impacts of 2020, it took us a whole year to do that. And then the stock price dropped. took a tanking and along with many others over the last couple of months, and it's been a challenging time. I'm here to tell you that we've never stopped believing, we have never stopped working, and we think we are beginning to see the benefits of not panicking, of not changing our business model, of not trying to fix it with one blow. We're putting one foot in front of the other. We put a strategy in place. We're executing on that strategy. We've got a great team, and I hope you'll all stick with it because I think there's great times ahead. Thanks again for coming, everybody. Take care, and I look forward to seeing you all soon. Bye-bye.

And thank you, sir. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.