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Ekso Bionics Holdings, Inc. (EKSO)

Q3 2016 Earnings Call· Wed, Nov 9, 2016

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Transcript

Operator

Operator

Greetings and welcome to the Ekso Bionics' 2016 Third Quarter Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Miss. Debbie Kaster with Gilmartin Group. Thank you. You may begin.

Debbie Kaster

Analyst

Thank you, Audrey [ph], and thank you all for participating in today’s call. Joining me from Ekso Bionics are Thomas Looby, President and Chief Executive Officer; and Max Scheder-Bieschin, Chief Financial Officer. Earlier today, Ekso Bionics released financial results for the quarter ended September 30, 2016. A copy of the press release is available on the Company’s website. Before we begin, I’d like to remind you that management will make statements during the call that includes forward-looking statements within the meaning of federal securities laws which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements including without limitation our examination of historical operating trends and our future financial expectations are based upon management’s current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. Ekso disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 9, 2016. I will now turn the call over to Thomas Looby. Tom?

Tom Looby

Analyst

Thank you, Debbie, and thanks everyone for dialing into our call this afternoon. I’m really proud of the great strides we have made at Ekso Bionics in the last several months with an approval to address more than 20 times, the patient population of any other exoskeleton technology in the market. Our team is focused on both short-term operational objectives to accelerate market adoption of our product as well as our long-term goal to established Ekso Bionics standard of care. Ekso Bionics has always had great engineers in the most cutting-edge Ekso exoskeleton technology. We are a human-centric robotics companies with singular focus is to help people realize their own inherent capabilities. For more than 11 years, our technical teams have pushed the boundaries on what was thought possible in both healthcare and able-bodied exoskeleton. But to help the greatest number of people and healthcare and industrial applications, we have to have more than just the best technology. We also need to run smart company that is why I’m so pleased to report on the progress our team has made in the last few months as we surround our technical excellence with the solid business that is focused on both short-term and long-term success. A few headlines from the quarter. In the last six months, we have concentrated on operational improvements which have brought us some great results. We shift 11 units in Q3, the first full quarter with our new label from the FDA, up from 8 units in Q2. We have now sold rented over 200 units to over 130 rehabilitation and hospital customers in North America and Europe. We saw continued improvement in our average direct sales price, up now to four successive quarters. We improved our medical device gross margin, which is up from 0% in…

Max Scheder-Bieschin

Analyst

Thanks, Tom. Now to some financial highlights, please see our accompanying earnings release and 10-Q for further details regarding the quarter. Total recorded revenue for the quarter was 1.6 million. Device and related revenue was 1.5, an increase from the 1.1 million for the same period last year. As you will note in our 10-Q, we now provide detail to breakout device revenue between medical and industrial. Of our device-related revenue, 1.1 million came from a medical business and 406,000 came from our nascent industrial business. This industrial revenue is up from 139 in Q2 as we are starting to see growing faction in sales of the Ekso arm. Revenue for engineering services unit was $101,000 compared with 1.8 million in Q3 2015. This reflects a strategic shift that Tom spoke about earlier this year to focus our engineering team on our next generation home mobility device. Our overall gross profit for the quarter was $403,000 for a gross margin of 25%, this compares to a gross margin of 16% for the same period last year. Gross margins for our medical business in Q3 were 25% as compared to 0% for the same period last year, driven in part by higher ASPs and in part by an improvement in our service business. Gross margin for industrial business services was 29% in Q3. Operating expenses for the quarter were $7.3 million as compared to $5.6 million for the same period in 2015. The increase was driven in part by the sales clinical and marketing investments we are making since our April clearance, and the increased R&D investment, we are making for the next generation home mobility product. Net loss for the quarter was 11.5 million, or 8.5 million before non-cash preferred deemed dividend expense as compared to a $5.2 million loss for the same period in 2015. Given that all the preferred shareholders have converted, we do not foresee any further non-cash preferred deemed dividend expenses. Cash used in operating activities for the quarter was 6.4 million. As of September 30, 2016, we have 12.8 million in cash and no debt. With that, I will turn the call back to Tom.

Tom Looby

Analyst

Thanks Max. Along with great technology one of the things that set Ekso Bionics apart is our strategy to establish our brand within the rehabilitation environment and to later expand into the home mobility market. We believe this is the smart approach because the rehab setting is where every patient needs to go first where a lot of the dollars are spent, and it is where we can best impact the trajectory of recovery for spinal cord in stroke patients. Our ultimate hope is to get these patients up and walking and to help reduce lifetime care costs. The rehabilitation clinic is where devices like ours are most capable safe and cost effective. It is also where we are best able to establish the trust of the medical practitioners who are the present day and future recommenders of mobility solutions. Because of our strategy to optimize the solutions for rehab, Ekso Bionics is a clear leader in both unit placements with over 200 to-date as well as site installation at over 130 centers. No other robotic exoskeleton comes close to these numbers. This initial success does not reflect the fact that we now also have a stroke label, a 20 times increased in patient population only we can address. Each year approximately 650,000 patients survive a stroke and 175,000 patients incur spinal cord injuries in the U.S. alone. We estimate that approximately 250,000 of these stations can be treated with our Ekso GT. Our success is also due to the unique design and fit of our product, which was carefully and specifically engineered for use in the rehabilitation clinic. The Ekso GT is easy to get into and out of, which translates into maximum productivity during each session while many competitive devices can take 30 minutes to get on and…

Operator

Operator

Ladies and gentlemen, at this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Imron Zafar with Suntrust Robinson Humphrey. Please state your question.

Imron Zafar

Analyst

I wanted to first ask about sort of the outlook for GT placement over the next few quarters. I know obviously you had the year-now, not having strong by the enforcement discretion and you have obviously the stroke label. I know you noted a 30% increase in demos since those overhang removals, but can you just talk about maybe what type of a quarterly unit placement run rate we should think about. Maybe exiting 2017 where we are now and where you think we could be as you look at the backlog just developed over the past couple of quarters? Thank you.

Tom Looby

Analyst

Imron, I think to your question. Yes, we are very excited now to get on the road and to talk about this label. We are really just exiting our first full quarter as you mentioned. And what we are surprised about is maybe we shouldn’t then surprised is that, customers just like the FDA were even regarding exoskeleton as devices for stroke, and now that we have the label, we are the only ones that can go and actually develop that market. So, our sales our marketing teams are making really good strides there. It has seen a 30% increase in the demos. We see that continuing as we go through quarters. What we are projecting I think for exiting Q4 2017 is probably about 10 units per month at that point time with still some room for additional acceleration.

Imron Zafar

Analyst

And then on, the home market -- I am sorry, if I missed this but is the timeline unchanged there in terms of getting regulatory approval and commercial launch sort of way next year early 2018?

Tom Looby

Analyst

You are talking about regulatory approval for what?

Imron Zafar

Analyst

The home segment.

Tom Looby

Analyst

For the home segment, yes, so we are very excited about what we are doing, and not all this is for public consumption, but we are now really making great strides. Again, we have a really good history. We probably have the most steps ever created with robotic exoskeleton. This has shown us a lot of knowledge about what to do, I think in the home. But we as a company believe, it's not going to be a one size fits all market. There are patients or users who are going to have major injuries and some of that are going to have minor injuries, so the technology platform that we are producing inside, we are going to have to package in different ways for those different patients. So that’s an issue that we are going to have to talk to the FDA about, putting the testing and so on. So, as you know, it's not just about the R&D, but it's about the regulatory path and the clinical path to get there. So, I think that we are on our timeline to be sure, but we see that it's probably being something in early 2019 must be first products.

Imron Zafar

Analyst

2019, okay. Thank year you. And then Max, a question for you. I guess sort of an extension to my first question about GT outlook for next few quarters on the top line, can you just talk about how we should be thinking about investments operating expenses over the course of 2017, just in light of the new label and the extended market opportunities and then as you start to think about enter into the home segment thereafter? Thank you.

Max Scheder

Analyst

Sure. On the R&D front, you’ve seen some increases on our investments there as we move our engineers from our engineering services, which was a billable revenue business and where they're focusing on the next generation home mobility Ekso device. So, you've seen some ramp up in the R&D, and we don’t anticipate significant increases there for the medial effort. On the sales and marketing side, we continue to make investments in studies, our own company-sponsored studies and proceeding towards reimbursement. So, you’ll see some increase on that side and a little bit more variable increase as more units get placed as well.

Operator

Operator

Our next question comes from the line of Jeffrey Cohen with Ladenburg Thalmann & Company.

Jeffrey Cohen

Analyst · Ladenburg Thalmann & Company.

I was wondering if you could give us a little more color as far as the sales organization at this point about the [indiscernible] as well as some of the international markets thus far and how that will work through 2017?

Tom Looby

Analyst · Ladenburg Thalmann & Company.

Yes. Right now, we have direct resources in the United States, and there we’re talking about direct sales people as well as clinical experts that sort of stand alongside of our sales force. We have the same thing in the core group of countries in Europe running by that it's the direct selling and direct clinical support in Germany, Switzerland, Austria and the UK and Nigeria. And we then do have distributors in other areas that often come along with that their own clinical expertise. What we’ve done in the last couple of months is focused on a lot of the sales operational side to support those groups, so that they're better educated. They’re starting with harder leaves, as we mentioned in our prepared statements that marketing has done a very good job of getting the message out about stroke. And then when the people are doing their self discovery, they are initiating the sales cycles on their own. We think this can help us short met sales cycle. So, we’ve talked about this in previous calls that we want to get the message out and then really have our sales people, take people through that sales cycle more quickly. We are seeing evidence of this in the first full quarter with our FDA label, and that’s why we have a sort of optimism that we will get to that three times run rate at the end of 2017, that we were predicting.

Jeffrey Cohen

Analyst · Ladenburg Thalmann & Company.

Okay. When you talk about three times run rate, can you give me some further color on that?

Tom Looby

Analyst · Ladenburg Thalmann & Company.

Yes. We were coming right of enforcement discretion where we had to be relatively silent or about a year and half at least in United States. We were, I think very happy with the number of units, but more happy with the ASPs that we were able to get in Q2. But we had about 10 units in that particular quarter. I think what we’re saying is that we would like to get 10 units per month as a run rate at the end of 2017. It’s going to be a ramp to be sure because it’s an education; it’s a change management challenge for us as we get this message out to the clinic. But Q3 could not have been better for us with the first full quarter with that label

Jeffrey Cohen

Analyst · Ladenburg Thalmann & Company.

And could you talk about some of those activities in the large European markets that you've been going after?

Tom Looby

Analyst · Ladenburg Thalmann & Company.

Yes, first, I'll start with our new leader over there who has been with us since the middle of September. I personally know Matthias and saw him out because we wanted to do what he is largely done two to three other times before in his career, which is to have the very firm sales operations, but more than just sales a complete organization over there. So, he is a seasoned distributor manager. He is a seasoned product manager and a direct sales manager as well. So, he is bringing all those capabilities with him. So, really in the last month and half, I've seen a really a step change function in the management and the organization of that team over there. I think it bodes well for us. They are doing a lot of what we are talking about on U.S. side again the capital equipment in marketplace. So how you will get into tenders earlier, how you write in language that supports the adoption of our product; and we are advantaged there because our product does more within the rehabilitation clinic than others. One thing I would also mention is we all know about the product adoption lifecycle, and early adapters the scientists and the large clinics with scientific budget adopt first. What that mean they can take a lot of intake all e-commerce and all different technologies. As we start to get into the second wave of adoption, it's going to have to be the product that makes the most sense logistically with regard to work flow, with regard to throughput of patients and that’s why it feels like we are advantaged in both Europe and United States when we get this message out.

Operator

Operator

That does conclude our question and answer session. At this time I'll turn it back to management for closing remarks.

Tom Looby

Analyst

We simply like thank you for taking the time to join our call today. I know it's been a busy day for many of you. Have a great evening. Thank you very much.