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Ekso Bionics Holdings, Inc. (EKSO)

Q4 2024 Earnings Call· Mon, Mar 3, 2025

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Transcript

Operator

Operator

Greetings. And welcome to the Ekso Bionics Holdings, Inc. Fourth Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone else requires operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Steven Kilmer. Thank you.

Steven Kilmer

Management

Thank you, operator, and good afternoon, everyone. Earlier today, Ekso Bionics Holdings, Inc. released financial results for the quarter and year ended December 31, 2024. A copy of the press release is available on our website. I would like to point out that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts shall be deemed to be forward-looking statements. All forward-looking statements, including statements regarding our business strategy, future financial or operational expectations, or our expectations of the regulatory landscape governing our products and operations, 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 the company's business, please see its filings with the Securities and Exchange Commission. Ekso Bionics Holdings, Inc. disclaims any obligation, except as required by law, to update or revise any financial or operational projections, its regulatory outlook, or other forward-looking statements, whether because of new information, future events, or otherwise. Any forward-looking statements made on this call speak only as of the date of this call. Representing Ekso Bionics Holdings, Inc. today are Scott Davis, our Chief Executive Officer, Jerome Wong, our Chief Financial Officer, and Jason Jones, our Chief Operating Officer. With that said, I will now turn the call over to Jerome.

Jerome Wong

Management

Thank you, Steve. Good afternoon, everyone, and welcome to our Fourth Quarter and Full Year 2024 Conference Call. On behalf of the management team and everyone at Ekso Bionics Holdings, Inc., I would like to thank you for your interest in our company. And for those of you who are shareholders, we appreciate your support. For the benefit of those who are new to the Ekso Bionics Holdings, Inc. story, I would like to take a moment to summarize our business. Ekso Bionics Holdings, Inc. designs, develops, and markets exoskeleton products that augment human strength, endurance, and mobility. The primary end market for our exoskeleton technology is healthcare. Our technology primarily serves people with physical disabilities or impairment in both physical rehabilitation and mobility. We operate as one operating and reportable segment with two markets: enterprise health and personal health. Our revenues are primarily generated through the sale and subscription of our Ekso NR device, our legacy wearable robotic exoskeleton specifically designed to be used in a rehabilitation setting to assist individuals recovering from both acute and chronic conditions. Our Ekso Indigo therapy device, our modular adjustable lightweight lower limb powered exoskeleton that can be custom-sized and fitted to patients for use in rehabilitation and wellness applications. Our Ekso Indigo personal device, which is a wearable lower extremity powered exoskeleton that enables certain individuals living with spinal cord injuries with the ability to stand and walk independently, along with the sale of support and maintenance contracts. I will turn the call over to Scott in a moment for an update on our commercial activities and growth plans. However, before I do, I would like to provide a brief summary of our financial results. To streamline things, all of the numbers I will refer to have been rounded, so they are…

Scott Davis

Management

Thank you, Jerome. While we're pleased to achieve record revenue in the 2024 fourth quarter, in many respects, our primary focus throughout those three months was on the future, particularly for Ekso Indigo Personal. As many of you know, CMS established pricing determination for the device in Q2 2024. Our main focus previous to this event was on post-acute care rehab hospitals and selling capital equipment within the legacy enterprise health market, with some focus on Veterans Administration for at-home devices. So establishing an effective market access function to operate within the CMS reimbursement framework was critical. As we discussed on our last call, after CMS provided pricing determination last year, we immediately set out to establish a go-to-market strategy aimed at notifying as many early physician and provider adopters as possible of the new CMS benefit category redetermination and the fee schedule listing. This regulatory change has created a significant opportunity to help Medicare enrollees living with a spinal cord injury by removing what has historically been a primary barrier to accessing our exoskeleton. Additionally, we began working closely with our extensive network of neurorehabilitation partners across the country focused on education efforts on appropriate patient selection and process for patients prescribed an Ekso Indigo Personal for the home and community setting. That good work was necessary but only part of what is required to drive the compelling growth opportunity that we continue to see ahead for the Ekso Indigo Personal starting in 2025. So throughout the year, we shifted our primary focus from building awareness and providing customer education to advancing our scalable go-to-market strategy for the personal channel. Significantly, in Q4, our earlier efforts led us to decide to make some key changes, which we believe will expand access to our technology and accelerate revenues in 2025…

Operator

Operator

Thank you. We will now be conducting a Q&A session. May you press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment while we poll for questions. And our first question comes from Li Chen with H.C. Wainwright. Please proceed with your question.

Li Chen

Analyst

Hello. This is Li in for RK. Thanks for the question. So my first question is, would you mind talking about your confidence in securing multi-unit orders for this year? And then second is how should we think of the volume of Indigo claims you plan to submit this year?

Scott Davis

Management

Thank you, Li. Thank you for your question. Thanks for joining us today. To answer your first question in terms of multi-unit orders, this is in reference to, I assume, our enterprise health business as it relates to some of our larger independent health delivery networks that are out there or larger network providers. As we had said, throughout 2024, it was an off-cycle year for those larger institutions as it related to their equipment purchases, and we expect and believe that in 2025, we are back within those standard procurement cycles for those larger customers. So the short answer is that we do expect more multi-unit orders occurring particularly back here in North America in 2025. Now, relative to the volume of claims submissions for CMS, as we stated, we have a current customer pipeline of individuals who we believe have effective and suitable claims relative to Medicare. That is about twenty-five individuals that we expect we will be putting through this year. In addition to that, we've really ramped up our marketing efforts throughout 2024, and we are getting individuals, you know, really daily who are coming into the queue and are interested in pursuing this technology. So we do see growth as we move through the year and we expect that it would be meaningful to the top line of our business as we move through the year and more importantly, we're really excited that we are starting to see individuals who can really benefit from using this technology in their day-to-day lives. So we remain quite excited about that.

Li Chen

Analyst

Okay. Thanks for the color. Another question is I see that the revenue in the Europe and the APAC regions are growing very nicely. Can you provide additional color on the growth trajectory you think will be in 2025 and beyond?

Scott Davis

Management

Sure. Well, in APAC, generally speaking, we have growth inside of APAC, generally year over year with our Ekso NR and our Indigo therapy devices. We also believe that in 2025, there's an opportunity for growth within the Indigo personal product line as well as there are reimbursement programs that exist in several of the regions in APAC. So, you know, we believe that that growth will continue to track. In Europe, particularly in 2024, we had really just exceptional growth in Europe as we had a huge opportunity within the French hospital systems where they were adding this technology into their neuro rehab programs. So as we are now in 2025, we believe that will begin to taper off and we'll get back to sort of what we call normal growth in that region, but we are projecting growth relative to our normal numbers in both of those regions in 2025.

Li Chen

Analyst

Got it. That's very helpful. Thank you very much. And congratulations on the quarter.

Scott Davis

Management

Thank you, Li.

Operator

Operator

Thank you. And our next question comes from Ben Haynor with Lake Street Capital. Please proceed with your question.

Ben Haynor

Analyst · Lake Street Capital. Please proceed with your question.

Good afternoon, gentlemen. Thanks for taking the questions. First off for me, just thinking about the patient interest that you're generating via your marketing activities for the personal units. And I think you mentioned, you know, almost daily, you're seeing folks enter the queue. You know, how many of those folks that do you do you know, get into the queue ultimately are, you know, well qualified, if you will, or you think that would benefit from taking them through the next steps?

Scott Davis

Management

Sure. Thanks, Ben. I appreciate your question and you joining today. We process a large and growing number of leads that are coming into our website. So we have a lot of interest from individuals who are, you know, many of whom are living with a spinal cord injury, but we have people who call us who have, you know, other mobility challenges related to, you know, other conditions as well. So, you know, our qualification process today is really taking individuals who are, you know, living with a spinal cord injury and meet the required FDA indication for use for the technology. From there, those individuals are screened just to ensure that they have the right health background and no preexisting conditions that would prevent them from effectively using the technology. And we also are prioritizing individuals with Medicare coverage with pure Medicare coverage today. What that means is that we have really different tiers of individuals who come in prioritizing Medicare first, but we have individuals who have Medicare Advantage, who have private insurance, who are otherwise well qualified for the technology. We continue to collect and foster those individuals' interest as we go forward. We expect over time that we'll be able to have reimbursement through those private insurance carriers over time. But today, we're prioritizing individuals with Medicare, who meet the physical requirements and health requirements for the technology. And, you know, in general, our number of qualified individuals that we talked about is about twenty-five that we have identified right now. But the reality is that there's an exponentially larger number of individuals that we continue to work with that we believe as this program becomes more mainstream and potentially moves into private insurance that will be good candidates in the future.

Ben Haynor

Analyst · Lake Street Capital. Please proceed with your question.

Okay. That's helpful color. And then on that latter point for the private payers, I mean, is that something that you can have Priya start helping with you with now, or is that, you know, down the road? What's the right way to think about that?

Scott Davis

Management

Well, I think the way we think about that today is we think about it today for down the road. I think one of the most critical elements of this is ensuring that we have good and consistent success with individuals with Medicare and then we can build upon that as we begin to engage with Medicare Advantage or with private insurance. It really kind of sets the precedent for those private payers down the road. Now that being said, the way we work with Priya to understand coding and coverage and payments and all of the various required medical letters of medical necessity and from physicians and all of this, this is all going it all translates into what will happen with private insurance. So a lot of what we're building today lends itself to those additional payers as we expand the program. But, you know, we're really trying to be conscientious as an organization. It's a little more of a challenging road at this point with people who have private insurance, and we really want to level set expect individuals who want and need access to the technology. We're trying to be very clear and forthright with people on that this is a new program and it will as it is taking a bit of time to develop as we predicted. But with Priya helping us, it ensures that we're not taking missteps along the way and we're guiding people in the right direction.

Ben Haynor

Analyst · Lake Street Capital. Please proceed with your question.

Okay. Got it. And then on the twenty-five or so patients that are Medicare, are there any commonalities between them? I mean, are they, you know, whether it's time since their spinal cord injury or age range or anything male, female, anything like that that stands out?

Scott Davis

Management

You know, at this point, Ben, they really run the gamut. We've had successful candidates, you know, if we go back and we look at Vicky Garrison, I mean, she had been in a wheelchair for twenty years. And had an incredibly positive experience and continues to with our Indigo Personal. It really is difficult to point to any specific demographic at this point. It runs the gamut. I will say at this juncture, what we are really seeking out is that people fit the screening that they get the appropriate healthcare screening and have the right coverage. But in addition to that, they're motivated and self-advocating. Because this is a new program, it's not as straightforward as, you know, going out and just getting a wheelchair or a brace or a CPAP or something like that. This is a new program. So it does take a bit of time. There's a certain amount of training involved. There's a commitment by the individual for this. So we're very clear in the process as we are screening these individuals that they understand what that is and that we just do a good job with education and level setting expectations for how the program works. So today, it really does run the gamut. We're really excited as these individuals start to get their devices at home and hearing their stories over time and really be able to see the sort of myriad of individuals that wind up being able to benefit from this.

Ben Haynor

Analyst · Lake Street Capital. Please proceed with your question.

Okay. Got it. And then lastly, for me, on the National Seating and Mobility as the distributor within the complex rehabilitation technology industry. Can you kind of tell us more about how that relationship came about? You know, maybe a little bit more on the CRT industry for folks that don't necessarily get into the weeds there and, you know, anything else that you might think here that you think might be helpful on that.

Scott Davis

Management

Yeah. Absolutely. So one of the key elements to this program being successful and we've been having these discussions quarter over quarter. Our view of Ekso's view of the go-to-market strategy for this really involves working with best-in-breed players, individuals or companies that have an expertise in DMEs, and that is that they're used to working with payers, with physicians, with healthcare providers to be able to tie all these different elements together for reimbursement. It is a complicated process. So it was early in 2024 where we began to really classic business development of looking at who those top players were in the industry. And NSM is certainly one of the big players in this space. Now CRT is, I guess, the simple way of looking at it is they do a lot with wheelchairs, with power wheelchairs, with mobility access for individuals who need help there. And these are generally larger ticket items, complicated, they all go through a relatively complex reimbursement process. They work with Medicare as well as with private insurers. Now what is unique, we've had direct meetings with their CEO. I've met with him personally and there's a common customer set here. The individuals who need power wheelchairs and need these mobility aids, this is the next evolution in that path for them is to be able to stand and to be able to walk. And starting with individuals with spinal cord injury, but over time, there's a belief that this technology can lend itself to others with mobility challenges. So with this relationship, it really is sort of a natural evolution for NSM. And for Ekso, it was really important to us to be able to work with one of the leading providers in the space and they really are the biggest and the best we feel in that space. Now at the same time, we continue to work on business development with durable medical equipment providers who are focused also in O&P or orthotics and prosthetics. We believe that that is effectively another targeted distribution group to be able to work with. So while we're signed with NSM exclusively in their space, we are also beginning work with some regional and national DMEs who focus in O&P as well.

Ben Haynor

Analyst · Lake Street Capital. Please proceed with your question.

Okay. Great. That's very helpful. Thank you so much for taking the questions, guys.

Scott Davis

Management

Thank you, Ben.

Operator

Operator

Thank you. And with that, there are no further questions at this time. I'd like to turn the call back to Scott Davis for any closing remarks.

Scott Davis

Management

Thank you, operator, and thank you to everyone for joining us today. As pleased as we are with the progress made in 2024 on the sales, distribution, reimbursement, and operations fronts, we're now excited and energized by what we believe 2025 will bring in terms of overall commercial traction in both the enterprise and personal markets. We look forward to updating you as we progress.

Operator

Operator

Thank you. This does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time.