ENDRA Life Sciences Inc. Q3 FY2020 Earnings Call

Good day, ladies and gentlemen. And welcome to your ENDRA Life Sciences Third Quarter 2020 Earnings Conference Call. All lines have been placed on a listen-only mode and the floor will be opened for your questions and comments following the presentation. At this time, it is my pleasure to turn the floor over to your host for today, Ms. Kim Golodetz. Ma'am, the floor is yours.

Thank you, Jess. This is Kim Golodetz with LHA, ENDRA’s recently engaged investor relations firm. Good afternoon and welcome to ENDRA’s third quarter 2020 business update and financial results conference call. ENDRA issued a press release on this topic earlier this morning. For those of you who don’t have a copy of the release, you can access it in the Investors section of ENDRA’s website at www.endrainc.com.

Thank you, Kim. Good afternoon, everyone. Thank you for joining us today to review ENDRA’s third quarter 2020 performance and 2020 business update. Along with David and me on today’s call are Renaud Maloberti, ENDRA’s Chief Commercial Officer; Michael Thornton, Chief Technology Officer, and as I mentioned, David Wells, our CFO. Let me go through today's agenda. First, I'll highlight our recent achievements including major milestones achieved in the last week, before handing it over to David to review the financials. Then Renaud will provide details on commercial activities with an initial focus on Europe where we have our first regulatory approval and, finally, we'll open the call for Q&A. For those of you who may be new to the ENDRA story, we're the pioneer of thermo acoustic enhanced ultrasound also known as TAEUS. TAEUS is a disruptive technology platform that allows clinicians to quickly visualize tissue in ways similar to an MRI, but at 50 times lower cost. TAEUS is simple to use as it can complete scans within minutes at the point of patient care. It works with existing ultrasound systems, which are in widespread global use. We have a collaboration with GE Healthcare, which supports our commercialization plans, but TAEUS is compatible with all major manufacturers of ultrasound. As we've shared before, there is an acute need for practical tools like TAEUS to assess and monitor liver fat to help more than one billion people globally affected by nonalcoholic liver disease or NAFLD and nonalcoholic steatohepatitis, also called NASH. Accordingly, the NAFLD, NASH diagnostic market is our primary initial focus and I continue to be very encouraged by our progress this year.

Thank you, François. Our third quarter 2020 financial results are as follows. Our operating expenses increased to $3.3 million for the quarter ended September 30, 2020, up from $2.6 million for the same period in 2019. This includes a total of $600,000 for non-cash charges, mainly equity compensation. Our research and development spending increased year-over-year by approximately $300,000 as we prepared our TAEUS system for commercial launch, including the necessary regulatory approvals, and our sales and marketing costs increased by a nominal $40,000 for the quarter as COVID-19 restrictions limited travel and in-person attendance at industry conferences. Our general and administrative costs increased by approximately $275,000 due to employment-related expenses, which included non-cash charges for stock compensation. Additional spending on costs associated with being a publicly traded company including investor relations and increased costs for insurance. Our net operating loss for the quarter ended September 30, 2020 was $3.3 million as compared to a net loss of $2.6 million for the quarter ended September 30, 2019. The portion of our net loss attributable to common shareholders, which includes funding-related non-cash charges, was $3.7 million and $3.4 million for the quarters ended September 30, 2020 and 2019 respectively. In Q3 2020, this amount is related to the exercise of certain outstanding warrants. Our operating net loss also includes non-cash charges, which totaled $1.9 million for Q3 2020 and are comprised primarily of charges for equity-based compensation and amortization of debt discount. Our net loss per share for the quarter ended September 30, 2020 was $0.15 per share. Our cash balance at September 30, 2020 was $3.8 million. This is after raising approximately $5 million in the early exercise of warrants held by long-term shareholders during this quarter. We remain diligent and vigilant, balancing our available cash and needs for cash against our outstanding equity and capitalization structure. We have and will continue to approach this balancing in several ways. First, by managing our burn rate through reductions where possible as we did in April with wage and fees converted to stock by our management and Board of Directors. We will spend only what we feel is prudent and focused on the market success for TAEUS. Second, by not allowing our balance sheet to consume cash unnecessarily for fixed assets or poorly timed increases in inventory. This is what we mean when we have said in the past about our asset-light operating model and third, by maintaining active communication with our long-time shareholders, building relationships with potential new investors and continuing to refine and retool the message about ENDRA's value to the market. This remains a critical path activity for ENDRA and will be for some time to come.

Thank you, David. From a commercial perspective, following the receipt of the CE mark throughout the third quarter, we accelerated our efforts in the market and building our brand to commence the commercialization of ENDRA's TAEUS in Europe. In the US, we continued building awareness in advance of FDA clearance. As François mentioned in his opening remarks, our commercial strategy centers on three key elements. The first commercial element is to establish evaluation sites in key markets. Despite the month-long COVID-19 impact on normal operations for healthcare facilities, our team successfully secured our first European evaluation site at the Johannes Gutenberg University outside Frankfurt, Germany during the quarter. We are also in the final legal review of evaluation sites in France and Switzerland and expect to finalize this agreement before year-end. We'll formally announce the site when they start scanning patients in the coming months, contingent on European business operations remaining open in light of COVID. One good example of our progress on this key commercial front is the news announced last week that our TAEUS system is now installed at Rocky Vista University. This is our first installation in the US, and it will be followed in the coming weeks with installations at other evaluation sites, namely the University of Pittsburgh Medical Center and the Medical College of Wisconsin. The data from these studies and evaluation sites will be used to bolster the clinical evidence and further establish the clinical utility of the TAEUS ultrasound device in patients with NAFLD to help accelerate commercialization in Europe and eventually the US, once the FDA clearance is secured. The second commercial element centers on building a small European sales team to work alongside GE's sales teams. On our last quarterly call, we announced that we hired our first salesperson in the UK and I'm happy to report that he is already making meaningful progress despite the challenges posed by COVID-19 travel restrictions. With this additional resource, we have been able to attend our first UK-focused liver conference, start the national health system enrollment process, and hold daily calls with UK clinicians that we believe will turn into customers. Given the pandemic, we've been careful not to hire people too early before the European market and healthcare systems open up. With that in mind, we now have someone in Germany who will support our evaluation site and ENDRA's TAEUS market adoption in this important European market. We also have a strong pipeline of candidates in other markets. We expect our salespeople to be able to capitalize on the extensive pre-marketing initiative that ENDRA has been conducting for the last several years and leverage ENDRA's global customer relationship database of over 4,000 clinicians. We expect the level of success to coincide with the rate at which hospitals return to more normal operational conditions in Europe. As discussed in previous calls, this commercial strategy will drive sales in the following ways: the sales reps will support and ensure the success of our clinical partners in each country or region. Our salespeople will also work with GE salespeople in each country or region to introduce ENDRA technology to existing and new GE ultrasound customers in radiology. Lastly, the ENDRA sales reps will drive awareness, interest, and trial for ENDRA's technology outside of GE's focus in radiology, specifically targeting clinicians in hepatology, endocrinology, and primary care. The third element of our commercial strategy is to increase ENDRA's e-marketing and education efforts. In the most recent quarter, we've built upon our previous work here by releasing additional educational videos and white papers, and we also translated our website into additional languages. ENDRAinc.com is now available in German, French, Italian, Spanish, and Chinese in addition to English. As a reminder, these efforts add to the library of tools and information now available to our sales team and potential clinical customers. Since many trade shows and conferences have been moved to a virtual setting, you'll recall that we built a digital trade show last quarter that allows us to attend global trade shows and conferences virtually and offer our potential customers a memorable virtual experience and the ability to learn and interact digitally with peers and the ENDRA team. The Annual Liver Meeting organized by the American Association for the Study of Liver Diseases took place virtually this past weekend and I am happy to report that this reaffirmed the increasing need for point-of-care invasive assessment tools for NAFLD as well as for providing information on the progress of NAFLD and NASH drugs. In addition, we connected with multiple potential customers visiting our booths and expressed interest in our solution. We believe ENDRA's virtual exhibition is open year-round on our website, so clinicians can learn about our innovative liver TAEUS liver solution on their own time, independent of conference dates. In summary, we continue to make meaningful progress towards our first TAEUS system sale; the global pandemic is not over yet, but we remain hopeful for our TAEUS solution to address the growing NAFLD and NASH challenge. The future of TAEUS and ENDRA looks bright and I look forward to updating you on our progress in future calls. Now, I will turn the call over to François, who will make some final remarks.

Thanks very much, Renaud and David. I'll wrap up the call before Q&A by emphasizing we're happy to deploy our first clinical system in the US and remain focused on ramping up commercialization activities in Europe, supporting the FDA review of our 510-K submission in the US, and exploring partnerships in the pharmaceutical sector. I look forward to providing investors with updates in the coming weeks and months as we make specific progress on all these fronts. With that, I'd like to open up the call for questions, operator?

Thank you. We'll move first to Brooks O'Neil of Lake Street Capital Markets.

I have a couple of questions considering the clear disruption caused by COVID both in the US and globally. First, are you receiving any signals from the FDA that approval might not occur within the usual timeframe? If that’s the case, when could we expect to see that approval? Additionally, could you discuss the situation in Europe? From my discussions with other companies, it seems that COVID spikes have led to stricter shutdowns in many European countries. How do you anticipate this will impact your efforts to commercialize the system in the first half of 2021?

Regarding FDA, as we pointed out on the call, we've not received any indication from the FDA that there are issues. They have engaged with us quite proactively on various normal questions, and beyond that, I couldn't say when approval might come. I don’t want to speak to the approval cycles. All I know is that clearly approval cycles typically turn around the six-month mark from filing. It's possible with the COVID-19 situation that the FDA is at times de-focused, but we've not experienced that. So I remain very optimistic about receiving clearance, and we'll certainly update investors on any material changes that occur going forward. Regarding the EU and COVID, I don't want to make excuses. No one can control COVID, and the reality for us is we need to do what we're able to do. This involves recruiting good people, as we've done now in the UK and just recently in Germany. The legal discussions on the evaluation sites in Europe continue also when we don't need to be there in person, and as Renaud mentioned, we've been continuing to build on the momentum to raise awareness and interest since really starting this process and going to at least 14 clinical conferences globally since 2018. So it's important to remember that clinicians, as well as administrators, as well as companies like ENDRA and GE and others are hampered, and the world has changed, but in a sense, work where it's a great equalizer. These virtual booths that we are using have been very cost-effective to get the message out. We're getting a good deal of interaction. Clinicians are attending, participating, and we've got a good exchange and a good amount of lead collection. I don't want to minimize the impact of COVID. Clearly, there's concern, but I will say just from the one sample that we've had now for a couple of months with our UK sales rep, he’s very active. He's engaging; clinicians are now fully engaged on Zoom and other virtual conferences. He's making development calls, and I think that that will bode well for commercial sales. We're not yet ready to signal when those sales will occur, but certainly, we're in the process of making those sales calls and remain optimistic that 2021 will be a fully commercial year for ENDRA. I don't know if that answers your question.

That's great. Let me change the subject a bit and ask you about the capital position. First, excellent job on raising $5 million through the warrants. I'm curious if you anticipate any further contributions from that source. Second, I'd like to know your expectations regarding renegotiations with GE. Could they potentially become a capital partner, and are you confident they'll participate again in 2021? Lastly, your comments about drug partnerships and opportunities sound very promising. On a preliminary basis, do you see potential for a financial partnership that could support the capital aspect as well?

So Brooks, let me tackle the GE and the pharma question and then I'll ask David Wells to speak a little bit more in detail to the capitalization-specific question. What I can share with you about GE is, as you know, many people on the management team and the board are ex-employees of GE. We have strong relationships there, and our contacts at GE remain stable and are committed to helping ENDRA. The liver space, for all the reasons I've mentioned, is clearly an opportunity for GE and other players. They see the opportunity to improve tools to screen and monitor patients with liver disease. So GE's focus in liver remains strong. I don't want to signal more than simply I believe the contract will be renewed, but certainly, as we advance both through the commercialization ramp and building clinical evidence, I believe the relationship with GE certainly has potential to get deeper, and I believe in time, it will. I have publicly stated that our goal is not to be in the box and accessory business long-term. We have to prove our clinical and commercial uptake to start with the installed base of enhancing ultrasounds, but longer-term, our goal is to be in the licensing of TAEUS to companies like GE and otherwise. As for pharmaceutical companies, I remain really bullish about that opportunity. It seems to have really reopened since the beginning of the year, and pharma and contract research organizations that run these clinical trials for NAFLD and NASH drugs are approaching us and expressing interest. We’re not looking to replace MRI yet, but a cheap, easy, safe tool could really be attractive for them. So I would say let's manage an initial collaboration with a goal of partnering, gathering data, and having the pharmaceutical companies prove that value in their clinical trials, and I could see that growing in 2021 to a potentially strategic investment and commercial relationship, but let's go one step at a time, and I'm excited about getting that first step started very soon. I hope that helps. David, could you please speak a little bit to Brooks' initial question?

Sure, and actually, I'll kind of pick up where you left off, which is the statement one step at a time. That's really what we're doing now. Establishing choices, as I talked about earlier, whether it be unregistered warrants, which indirectly answer your question, are there additional warrants that are exercisable? The answer is yes. Then we also look at various market-based funding opportunities available to us from the strategic partnerships and non-dilutive academic research grants. I think the key here is to keep taking one step at a time to see how the company is being perceived in terms of overall value. See how the market is responding to some of the unique circumstances of 2020, COVID, and others, and continue to make our best decisions. I'm very proud of the decisions we have made over the years. We've made good choices about how we're going to capitalize ourselves, and we're going to continue to make those good decisions.

That's great, David. Thanks for all that color.

Thanks again, Brooks. Operator, do we have any more questions?

We'll move next to Ed Woo at Ascendiant Capital.

My question is on the reference sites and evaluation sites. Do you have plans beyond the three initially targeted in the US and three that you guys have targeted for Europe?

Yeah, thanks, Ed. Great question. Our thinking in terms of how fast we've scaled that is how well can we support it and what are we learning? It's more a question of staging multiple sites over time. The answer is yes. We want to have a reference site in each target market: the UK, France, Germany, Italy, Switzerland, and others, but we also want to support them well and learn in the process. Staggering them gradually over time is beneficial that way. In the US, we have three sites: the Mid-Atlantic University of Pittsburgh Medical Center, the Midwest Medical College of Wisconsin, and in the Southwest, the installation at Rocky Vista University. That gives us a good geographic distribution. Our criteria for selecting these sites was, one, geographic, because clinicians in France or clinicians in the Northeast like to hear about data and potentially want to visit and see the unit in clinical use at a site near them. The other elements are that we want these evaluators to clearly see the same potential for a tool like ours. Several of the evaluators, including the University of Pittsburgh, which is a liver center of excellence, approached us at the American Association for the Study of Liver Disease Conference. We view them as real partners. They must be objective; we don't run these studies or control them, but they have the right interest and commitment to making a successful case for their patients as well as for ENDRA and other clinicians. So yes, we'll continue to build out additional sites as we are able to support them, initially focusing on Europe and in the US. I hope that answers your question, Ed.

Yes, it does. And then regarding each evaluation site, how much involvement of both resources and money is involved for you guys to participate?

Yeah, great question. I won't reveal how much we are paying per patient because that's obviously confidential, but I will say that GE has been very helpful in providing us with ultrasound systems that we don't have to buy. We are deploying turnkey systems to these sites—our own system plus GE ultrasound systems—to enable a speedy and, as I mentioned, turnkey operation of these sites. These sites will scan patients ranging from 75 to 200 scanned on the MRI PDFs, which is the gold standard from a research perspective, and then scanned on our system for comparison. We expect these studies to take typically six to nine months. We'll see the results of these studies start to come out in the end of the first half of next year, but I also want to emphasize that commercially we're not waiting for that data to come out. Those are reference sites, evaluation sites, and our salespeople in each country are actively soliciting customers in our customer relationship management database and being introduced to customers by GE. So it's happening in parallel to our commercial sales. Once those evaluation sites complete their studies, we fully expect and will work very hard to keep them satisfied, so they will become commercial sites for us and commercial customers. I want investors to think about revenue for us next year, not in terms of singular sales associated with our sales reps, but really site-wide, healthcare system-wide sales. Without at all inferring that UPMC has made a commitment this way, it's public information that UPMC is a large healthcare system with at least 40 hospitals. So getting our foot in the door, generating goodwill, proving the case with our technology sets us up for a stronger, potentially commercial relationship. That's not the case today, but I want investors to start thinking ahead; a good commercial relationship with a site like UPMC could turn into a significant bulk buy for ENDRA. Okay, hope that's helpful, Ed.

Yes, that was very helpful, and I wish you guys good luck. Thank you.

With no other questions holding, Mr. Michelon, I'll turn the conference back to you for any additional or closing comments.

Yeah, thanks very much, Jess. Thank you, everyone, for joining us this evening. We're very excited about ENDRA's future, and we're pleased to have shared our plans with you this afternoon. I do want to mention that we do have an active Investor Relations program and are available for virtual meetings with the investment community. Please contact our IR partners if you'd like to schedule a meeting. Also, I want to mention that we're participating in two investment community conferences this week. Tomorrow, November 17, we'll be presenting at the Virtual Investor Summit at 1:30 Eastern Time, and on Thursday, November 19, we'll be participating in AGP's Virtual Healthcare Conference, which is a one-on-one format. Thank you again, everyone. I wish you well, and good afternoon.

Ladies and gentlemen, that will conclude today's programming. We thank you for your participation. You may disconnect at this time and have a great day.