Ekso Bionics Holdings, Inc. Price & Performance (EKSO)

At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, this conference is being recorded. It is now my pleasure introduce Steven Kilmer. Thank you. Thank you, operator.

Good afternoon, everyone.

Earlier today, Exco Bionics 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, 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 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. Xgold disclaims any obligation, except as required by law, to update or revise any financial or operational projections, as regulatory outlook [indiscernible] 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 ESCO Bionics 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. Thank you, Steve. Good afternoon, everyone. And welcome to our fourth quarter and full year twenty twenty four Conference call. On behalf of the management team and everyone at Exel Bionics, 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 story, I would like to take a moment to summarize our business. Ekso designs, develops and markets EksoSkeleton products that augment human strength, endurance and mobility. The primary end market for our exoskeleton technology is healthcare, where 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 to 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. [indiscernible] 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, 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 approximate. The company recorded revenue of $5,100,000 in the fourth quarter of twenty twenty four, an increase of 5% compared to $4,800,000 for the same period in 2023.

Gross profit for the fourth quarter was $2,700,000 representing a gross margin of approximately 53% compared to a gross profit a gross margin of 49% for the same period of 2023.

The increase in gross profit and gross margin was primarily due to Cost savings in supply chain and reduction in service costs. Operating expenses for the fourth quarter of twenty twenty four which consists of R and D, G and A, and sales and marketing expenses were $4,900,000 a 15% decrease compared to $5,800,000 for the fourth quarter This was primarily due to a decrease in headcount, discretionary payroll, consultant costs.

Net loss applicable to common stockholders for the fourth quarter was $3,400,000 or $0.14 per basic and diluted share compared to a net loss of $3,200,000 or $0.22 per basic and diluted share the same period of 2023. For the fourth quarter twenty twenty four, the company used $1,400,000 of net cash in operations, compared to $1,600,000 for the same period in 2023.

Turning now to our full year 2024 results.

Revenue of $17,900,000 was down from $18,300,000 for the same period in 2023.

I think it's fair to pause here for a moment to address the marginal year over year decline. It essentially came down to a difficult 2023 comparable driven by two main factors. First, we were on the procurement cycle with several of the large independent delivery networks in 2023. But not in 2024.

Second, 2023 was our first full year of having the Indigo Personal product line. Which we acquired from Parker Hannafin in late twenty twenty two. As part of that acquisition, we inherited an approximately $2,000,000 pipeline that Parker Hannafin had with the VA, but weren't able to fulfill due to the impact of COVID. We delivered most of those devices in 2023. And we're rebuilding that pipeline in DA through 2024. Gross profit for the full year ended 12/31/2024 was $9,500,000 representing a gross margin of approximately 53% compared to a gross profit of $9,100,000 for the same period in 2023. Representing a gross margin of 50%. The increase in gross profit a result of cost savings and supply chain and a reduction in service costs. Operating expenses for the 2024 full year were $20,000,000 a 17% decrease from $24,200,000 for the prior year period.

The improvement was a result of lower headcount discretionary payroll, consultant, legal and accounting costs.

Net loss applicable to common stockholders for the 2024 full year was $11,300,000 or $0.56 per basic and diluted share, compared to a net loss of $15,200,000 or $1.1 per basic and diluted share for the 2023 full year.

Cash used in operating activities in the 2024 fiscal year was $9,800,000 down from $12,100,000 for the same twelve month period in 2023. At 12/31/2024, the company had cash and restricted cash of $6,500,000 That's it for my summary of the fourth quarter full year 2024 results.

Please see our Form 10 ks for further details regarding the results. I'll now turn the call over to Scott.

Thank you, Jerome. [indiscernible] While we're pleased to achieve record revenue, in the twenty twenty four fourth quarter, in many respects, our primary focus throughout those three months was on the future, As many of you know, CMS established pricing determination for the device in Q2 twenty twenty four. 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 reimburse 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 adopt 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 neuro rehabilitation partners across the country focused on education efforts on appropriate patient selection and process for patients prescribed in 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 Significantly in Q4, our earlier efforts led us to deciding to make some key changes, which we believe will expand access to our technology and accelerate revenues in 2025 and beyond.

One of these key changes was engaging PREA Healthcare, a leading full spectrum reimbursement services and market access firm has been instrumental in the successful commercialization of over 300 medical devices.

Let me provide some perspective on why that move is so important. Through a national durable medical equipment or DME Partner. We submitted our first Medicare claim at the May. In July, we saw our first claim reimbursed. All subsequent claims are currently being managed through the appeals process and in Q4 we elected not to submit additional claims. But that's not to say that we haven't been busy. Fact, we've already built a backlog of more than 25 Medicare beneficiaries that we believe are great candidates for Ekso Indigo Personal and through our retargeting efforts are continually identifying new candidates who we believe are qualified. Moving forward, with Priya's help throughout the submission process, We anticipate submitting those claims to CMS over the next six to nine months. While we obviously cannot guarantee those claims will be submitted, in that timeframe or ultimately be paid, We are confident that Priya has the ability to provide us with strategic guidance leverage its expertise to help Ekso navigate the complexities of coding, coverage, and payment, ensuring that Ekso Indigo Personal reaches the individuals who need this potentially life changing mobility enhancing technology. Quite frankly, we didn't have that confidence without them.

Thus our reluctance to submit Medicare claims in the fourth quarter. In another move designed to broaden access to Ekso Ekso Personal, a few weeks ago, we named National Seating and Mobility as the company's exclusive distributor of the personal device within the complex rehabilitation technology CRT industry in The United States This marks our first entrance into the large and growing CRT space. With a network of over 180 locations and more than 2,400 team members who support more than 250,000 mobility solutions each year, We believe NSM is ideally suited to help us expand the distribution of Indigo Personal through this new strategic partnership. We are also ramping up pilots and partnerships with both regional and national DME suppliers who focus on traditional orthotics and prosthetics or O and P. All that said, I want to reiterate that this is a go to market program for the Ekso Indigo Personal that will continue to take time to But the good news is while the majority of our revenue in 2025 will still come from enterprise, we believe we will start to see increased contribution from our personal health products Now shifting briefly to operations. We are continuing to drive more efficiencies throughout our business.

Our improvements in supply chain and inventory management, along with efficiencies gained in production, resulted in strong gross margin for the fourth quarter. Overall, we are pleased to have improved our operating margins in the quarter. And while gross margin may continue to vary some quarter over quarter, we believe that it will continue to trend up as 2025 progresses.

In summary, the fourth quarter was another period of tremendous change and significant progress for Ekso Bionics, marked by record revenues, strong gross margins and the building of a scalable go to market strategy for Indigo Personal. Supported by both established and new industry leading DME and market access partner This ends our prepared remarks for today. With that, we are happy to take any questions you might have. Operator?

Thank you.

We will now be conducting a Q and A session.

And our first question comes from Lee Chen with H. C. Wainwright. Please proceed with your question. Hello. This is Lee in for RK. Thanks for the question. So my first question is, would you mind talking about your confidence in securing multi order multi unit orders for this year? And then second is how should we think of the volume of indigo claims do you plan to submit this year?

Lee, thank you. 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 [indiscernible] as it relates to some of our larger independent health delivery networks that are out there, our larger network providers. As we had said throughout 2024, we were 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 tenant 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 about 25 individuals that we expect we will be putting through this year. In addition to that, really ramped up our marketing efforts throughout 2024 and we are getting individuals 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 would be meaningful to the top line of our business as we move through 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 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 see you think will be in 2025 and beyond?

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 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 as we are now in 2025, we believe that 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 in both relative to our normal numbers in both of those regions in 2025.

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

Thank you, Lee.

Thank you.

Our next question comes from Ben Haynor with 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 almost daily you're seeing folks enter the [indiscernible] How many of those folks that do you do Get into the Q Ultimately, our well qualified, if you will, or you think that would benefit from taking them through the next steps?

Sure. Thanks, Ben. I appreciate question and you joining today. [indiscernible] large and growing number of leads that that are coming into our website. So we have a lot of interest from individuals who are many of whom are living with a spinal cord injury, but we have people who call us who have other mobility challenges related to to other conditions as well. So our qualification process today is really taking individuals who are living with a spinal cord injury and meet the required FDA indication for use for the technology. From there, those individuals are are screened just to ensure that they have the Right. [indiscernible] background and no preexisting conditions that would prevent them from effectively using the technology. 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 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 those individuals interest as we go forward. And 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 with Medicare who meet requirements and health requirements for the technology And in general, number of qualified individuals that we talked about is about 25 that we have identified right now, but 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 and potentially moves into private insurance that will be good candidates in the future.

Okay.

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

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 a 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 private insurance, it really kind of sets the precedent for 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 letters of medical necessity and no from physicians and all of this. This is all going it all translates into what will happen with with private insurance. So a lot of what we're building today lends itself to those additional payers as we expand the the program. But we're really trying to be conscientious as a 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 expectations for individuals who want and need access 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.

Okay, got it. And then on the 25 or so patients that are Medicare are there any commonalities between them? I mean, are they whether it's the time since they're spinal cord injury or age range or anything male, female, anything like that that stands out At this point, Ben, they really run the run the gamut We've had successful candidates. If we go back and we look at at Vicki 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. We have it really It's difficult to point to any specific demographic at this point. It 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 and and have the right coverage. But in addition to that, [indiscernible] motivated and self advocating. Because this is a new this is a new program, It's not as straightforward as going out and just getting a 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 So we're very clear in the process as we are screening these individuals that they what that is and that we just do a good job with education and level setting expectations for how the program works. So So today, it really does run the gamut. We're really excited as individuals start to get their their devices at home and hearing their stories over time and really be able to see sort of myriad of individuals that wind up being able to benefit from this Okay, got it. And then last CDN and Mobility as the exclusive to within the complex rehab technology industry. You kind of tell us more about how that relationship came about?

Maybe a little bit more on CRT industry for folks that don't necessarily getting to the weeds there and anything else that you might think here that you think might be helpful on that?

Yes, absolutely. So one of the key elements to this program being successful we've been having these discussions quarter over quarter. Our view of XO's view of the go to market strategy for this really involves working with best in breed players, individuals or companies that that have an expertise in as DMEs and that is that they're used to working with payers with physicians healthcare providers to be able to tie all these different elements together for reimbursement. It is a It is a complicated process. So it was early in in 2024 where we began to two 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. [indiscernible] CRT is [indiscernible] simple way of looking at it is they do a lot with with wheelchairs, with power wheelchairs, with mobility access for individuals who who need help there. And these are generally larger ticket items, complicated They all go through relatively complex reimbursement process. They work with with Medicare as well as with private insurers. Now what is unique, we've had direct meetings with with their CEO. I've met with him personally and there's a common 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 can lend this technology can lend itself to others with mobility challenges. So with this relationship, it really is sort of a natural evolution [indiscernible] for NSM, And for Ekso, it was really important to us to be able to work with one of the leading providers in this space and they really are the 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 and P or orthotics and prosthetics. We believe that that is effectively another targeted distribution group 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 and P as well.

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

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.

Thank you, operator, and thank you to everyone for joining us today. As pleased as we are with the progress made in 2024 on 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 Thank you. This does conclude today's teleconference. Thank you for your participation. May disconnect your lines at this time.