Ekso Bionics Holdings, Inc.

Greetings and welcome to the ExoBionics fourth quarter 2023 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow a formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Matt Steinberg, FinPartners. Thank you. You may begin.

Thank you, Operator, and thank you all for participating in today's call. Joining me from Exobionics are Scott Davis, Chief Executive Officer, Jerome Wong, Chief Financial Officer, and Jason Jones, Chief Operating Officer. Earlier today, Exobionics released financial results for the quarter and year ended December 31, 2023. A copy of the press release is available on the company's website. Before we begin, I would like to remind you 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 fact should 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 our businesses, please see our filings with the Securities and Exchange Commission. EXO 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. I will now turn the call over to ExoBionics Chief Executive Officer Scott Davis.

Thank you, Matt. We're excited to have closed out 2023 on a positive note, highlighted by record annual revenues of $18.3 million, an increase of 42% from the prior year period. Our solid results reflect continued improvements in consistency of returns from our scalable commercial strategy, in addition to the early contributions of our Indigo product lines that we acquired in late 2022. On today's call, I'll briefly review our fourth quarter 2023 results and share other business updates. Starting with our Q4 results, we generated revenue of $4.8 million in the fourth quarter of 2023. 36% increase from the same period in 2022. During the quarter, we sold 38 ExoHealth devices. Throughout our enterprise ExoHealth segment, inpatient rehabilitation facilities continue to leverage our advanced exoskeleton technology to help stroke, traumatic brain injury, multiple sclerosis, and spinal cord injury patients on the road to recovery. Our clinically proven patient improvements in functional outcomes support our efforts to elevate the standard of care for neuro-rehabilitation. Additionally, the economic value proposition for neuro-rehab providers that implement our ExoNR and ExoIndigo therapy devices into their programs have been shown to increase patient throughput and drive higher patient volumes. Altogether, we continue to translate these compelling data points into our commercial strategy by selling both multi-unit orders and multi-unit renewals to our vast network of operators. The output from our commercial team led to a record year of ExoHealth devices sold. For the full year 2023, we sold 151 ExoHealth devices, up 51% from 2022 levels. We believe we are well positioned to build upon this momentum to drive sustained growth for our ExoHealth enterprise devices as we continue to strengthen our distribution network and expand our pipeline of opportunities. Earlier this year, we were pleased to have launched our GateCoach software for XONR. GateCoach is our next generation gate therapy software for XONR that simplifies the use of robotics. The intention is to improve user trust in technology, provide impactful dynamic feedback, and offer specific guidance acting as an extra set of clinical eyes. We believe GateCoach will reduce training demands and increase utilization, making the device more intuitive and easier to use for both patients and physical therapists, and marking a milestone in improvement of our product portfolio. Users of XONR recently introduced to GateCoach through initial survey results have exhibited support for this software upgrade, with nearly all users finding it to be intuitive. Feedback also indicated that guidance from GateCoach makes XONR easier to use. is useful for new or less experienced therapists at the clinic, and is believed to further help patients achieve their clinical goals. A demonstration of this exciting new software can be found on our website. Now turning to an update on our ExoIndigo Personal device. On February 29th, CMS announced that it deferred payment determination for personal exoskeletons, including the ExoIndigo Personal. As part of its communication, CMS requested additional examples of non-Medicare payer data that would support a payment determination for products to qualify under HCPCS code K1007, such as our Indigo Personal. We intend to provide materials to CMS to help provide additional commercial details supporting a reimbursement rate. Until a reimbursement rate has been established, we will provide relevant support to help our customers process Medicare claims on a case-by-case basis. As we've done throughout 2023, we will continue to offer our Indigo personal device to veterans through the VA's established reimbursement program. The lightweight, packable, modular design of this device allows individuals living with a spinal cord injury to more easily bring it along with them for use in their communities, and the advanced gait feature allows them to achieve average walking speeds, an important consideration if navigating crosswalks. XO is committed to delivering well-built, affordable products and to help enable this potentially life-changing technology reach a higher number of individuals living with a spinal cord injury. We look forward to our continued work with CMS and the SCI community. On the international front, we achieved solid performance across EMEA and APAC regions as we generated an increase in sales volume built on the strength of our distribution network. Not only are we getting more placements, but our network enables us to gain operating leverage abroad. Notably, in the fourth quarter, we generated multi-unit EXO NR sales across Eastern Europe. Looking ahead, we continue to focus on building relationships with larger customers in these regions as we invest in our international footprint to support EXO's ongoing growth across the globe. Now I'd like to turn to an update on our industrial segment, EXO Works. In 2023, we drove notable progress in our industrial product line, especially on the operational side with the implementation and initial supply of EVOs from our new high volume contract manufacturer. By reducing supply constraints and substantially lowering costs for our contract manufacturer relationship, we believe we'll be able to better meet the supply and pricing demands of our potentially high volume industrial customer pipeline. Based on this, we feel we are poised for continued growth and market expansion. While revenue contributions from our industrial segment have recently been at modest levels, we remain steadfast in our commitment to maximize EVOS placement in large industrial settings, leveraging a significant emerging market opportunity. Overall, I'm enthusiastic with our record-breaking revenue performance in 2023. We're focused on building out the market across the continuum of care for pioneering exo-health devices and believe we are well-positioned to deliver on our objectives. Now, I will turn the call over to Jason Jones, our Chief Operating Officer, for an operational update.

Thank you, Scott. I'm pleased to report several key achievements and developments within EXO's operations in 2023. First, we've bolstered our operating leverage, reflecting a more efficient and scalable operational model. While our revenues grew by 42% year-over-year in 2023, our operating expenses increased by only 11%. We believe this is indicative of the operating leverage we're able to achieve going forward as we continue to manage expenses. Further, our efforts in inventory management have allowed us to reduce our inventory on hand by 3% as of the end of 2023 compared to the prior year despite strong revenue growth. We believe there is still room to improve on inventory efficiency. In Q4, we also completed the transition for our Ohio team from Parker-Hannifin's IT system to a new electronic quality management and product lifecycle management system. This new system is expected to be the foundation of our product development and quality processes going forward, with the entire company plan to transition over throughout 2024. We believe that consolidating our teams onto a single system will improve collaboration across our sites, and once fully implemented, will reduce audit and compliance costs. At this time, I'd like to turn over the call to our Chief Financial Officer, Jerome Wong, to review our fourth quarter and full year financial results.

Thank you, Jason. We generated an increase in the fourth quarter of 2023 revenues of 36% to $4.8 million compared to $3.6 million for the fourth quarter of 2022. Increase in revenue is primarily due to an increase in the volume of XONR and Indigo device sales. Gross profit for the fourth quarter was $2.4 million, representing a gross margin of approximately 49% compared to a gross profit of $1.7 million and a gross margin of 47% for the same period of 2022. The 41% increase in gross profit was primarily driven by an increase in ExoHealth device sales. Margin expansion was primarily due to lower ExoHealth device and service costs. Operating expenses for the fourth quarter of 2023 were $5.8 million compared to $6.1 million for the fourth quarter of 2022. A 5% decrease was primarily due to a decrease in general and administrative expenses stemming from lower legal expenses. Net loss applicable to common stockholders for the fourth quarter was $3.2 million or 22 cents per basic and diluted share compared to a net loss of $3.2 million or 24 cents per basic and diluted share for the same period of 2022. Operating cash burn for the fourth quarter was $1.6 million compared to $3.7 million in the fourth quarter of 2022. Turning to our full year 2023 results, revenue increased by 42% to $18.3 million compared to $12.9 million for the same period in 2022. The increase in revenue was primarily driven by an increase in ExoHealth device sales of $5.9 million. Gross profit for the full year ended December 31, 2023, was $9.1 million, representing a gross margin of approximately 50%, compared to a gross profit of $6.2 million for the same period in 2022, representing a gross margin of 48%. The increase in gross profit was a result of lower device and service costs and product mix. Operating expenses for the 2023 full year were 24%, compared with $21.8 million for the prior year period. The increase in operating expenses was primarily related to the acquisition and integration of HMC. Net loss applicable to common stockholders for the 2023 full year was $15.2 million, or $1.10 per basic and diluted share, compared to a net loss of $15.1 million, or $1.16 per basic and diluted share. for the 2022 full year. Cash used in operating activities in the 2023 fiscal year was $12.1 million. As of December 31, 2023, the company had cash on hand of $8.6 million. Subsequent to year end, XL closed on a registered direct offering with certain institutional investors, resulting in total net proceeds to the company of approximately $3.9 million. Please see our Form 10-K filed earlier today for further details regarding the quarter and full year. Operative, you may now open the line for questions.

Thank you. And ladies and gentlemen, at this time we will conduct our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, ask a question. Press star 1 on your touch-tone phone. Stand by while we poll for questions. Our first question comes from RK with HC Wainwright. Please state your questions.

Thank you. Good afternoon, Scott and Jerome. Hello, RK. The question is on Indigo pricing. So I did hear that you're still in discussions with CMS on the final pricing, and up until they come up with a number, it's case by case. So what do you need to do in terms of – helping CMS come to a decision so that we have a price that will become effective on April 1st, which is not too far from here.

Yeah. Thank you, RK. So, with CMS's recent announcement, they have requested additional commercial pricing evidence. when this meeting took place in November. EXO had provided commercial pricing information to CMS. However, in the November timeframe, we were not officially approved through PDAC for our Indigo personal device, which was done on December 9th. As a result, it appears that CMS did not include this pricing information in their evaluation. So we plan to provide this information to CMS along with any additional details that they require. And in the interim, we'll continue to work with our customers to provide commercial pricing information to support their Medicare claims on a case-by-case basis.

Okay. So does this mean... we might have to wait for the next cycle to start, which is November 1st, for a final pricing, or there's a possibility that things can get resolved before April 1st?

Yeah, there's a, you know, we, you know, spoke with our consulting experts who are in this area, and CMS typically has biannual meetings where they publish their pricing determinations However, we are told that it's possible that they could issue a correction prior to that biannual meeting. We'll certainly know more as we work through this process. In the time being, we're going to continue to support CMS by providing the requested additional pricing detail to support this final payment determination.

Okay. Thanks for that. And then thinking through the growth in sales, especially in the fourth quarter and also for the entire year, 36% growth year-over-year in the fourth quarter is really something to be proud of. How much of this sales increase is sustainable I'm just trying to understand, did you open up new areas, new areas where the sales are happening, or do you have some new accounts where you expect to see more of this multi-unit sales slash multi-unit leases to happen going into 24 and beyond? Sure.

Great question. One of the things that we've been hard at work on is building a strong pipeline and a scalable go-to-market strategy inside of our organization. And much of that relates to our enterprise health customers, customers who are using our NR or indigo therapy to treat patients in clinics. We have been saying quarter over quarter that we have an increased number of multi-unit orders coming in as we become more of a standard of care inside of these IDNs. And what we are seeing are a combination of new IDNs who are coming online with their programs and rolling them out to additional hospitals. And in addition to that, We've been doing this now for a couple of years, so we also have renewals of programs with existing IDN customers. So we continue to grow our pipeline with these larger operators in North America. In addition to that, we are seeing significant growth in Europe. You know, we have distribution relationships in Europe that are continuing to grow and evolve and expand geographically. So between the geographic expansion, the scalable go-to-market strategies, and the work with the integrated delivery networks, we are seeing this growth, and we believe that this growth will continue going forward.

Okay, and then the last question from me is on the operating expenses. In addition to what you're doing at the Ohio plant, are there additional cost containment programs in place? And should we expect some operating margin expansion in 24?

Yeah, this is something that we continually work on, RK. You know, we did a lot of work on this in 2023, and we really saw the positive effects of that in the back half of the year. We had a lot of costs in the early part of 2023 that were associated, you know, with, you know, our HMC acquisition. We had, you know, legal and accounting costs that were associated with that that you saw in the first half that you didn't see in the back half. So again, those costs, one-time costs, we don't anticipate those going into this year, but we are doing all we can to maintain the utmost in operating efficiencies in terms of cost control, in terms of inventory management, You know, we continue to work on that as well as work on cost improvements to help keep the margin trend line going in the right direction.

Okay. Thank you. Thanks for taking all my questions.

Thank you, RK.

Thank you. And a reminder to the audience, ask a question, press star 1. Our next question comes from Ben Hainer with Alliance Global Partners. Please state your question.

Good afternoon, gentlemen. Thanks for taking the questions. Can you hear me okay? Yep, we can hear you fine, Ben. Okay, great. Just a couple of big picture ones for me. On kind of the referral path for the personal units, how do you see that changing versus kind of what's in place now as the CMS kind of has made the decisions that they've made and deferred the decision on pricing and what's the right way for investors to think about, you know, how those referral pathways happen, what docs do in terms of if there's reimbursement in place, are they more likely to write a prescription, anything in color on how you see that developing would be helpful.

Okay, yep, understood. So, you know, I think... You know, two parts to this question. One, you know, one important and clear indicator is that the, you know, the HCPCS code, you know, K1007, you know, has been approved so doctors can prescribe against this code. That hasn't changed. That was announced back in November timeframe. And what we're waiting for is final payment determination on a fixed amount. In the interim, what will happen along with any Medicare submission that comes through, there will need to be some backup of commercial pricing documentation, historical commercial pricing documentation. So along with the approval request from the doctors will be a package That also includes recent purchases of the equipment. And again, at XO, we have several years of documentation that we can provide them supporting a, you know, reimbursement rate that, you know, that could be viewed by CMS. So in general, the process is there. It's really considered a case-by-case until final price determination has been set. But in the interim for those who are putting claims in, now it will need to be accompanied by that commercial pricing information.

Okay, and so do you have any thoughts on potential reluctance to write restrictions if there's, you know, it's under a case-by-case basis, or don't you think that really has an impact?

Yeah, so in general, you know, we're not anticipating a reluctance, you know, per se. You know, again, this is... The reimbursement of an exoskeleton as a brace through a lump sum is a new program through CMS to begin with. So early on in the process, EXO has spent a decade building strong relationships with our healthcare provider network that's out there. We will continue to work with them to ensure they have the information that they need for the best opportunity to have a claim reimbursed. And, you know, again, you know, generally speaking, we have had, you know, a very positive reaction by our health community regarding this program.

Okay, got it. So basically early adopters are early adopters regardless of whether it's on a case-by-case basis or not for the most part. Is that fair? That is fair, correct. Okay, got it. That's very helpful. And then, you know, I think you talk about this in your deck, and I think you mentioned it on your last conference call, 160-odd thousand Medicare patients that have SCIs. What's your thoughts on those that are truly addressable and the sort of subpopulations that – you know, maybe particularly addressable and how easy those are to go after. Any color that would be helpful.

Sure. And, you know, I think there's a certain level of, you know, physicality and there's a screening process that individuals go through to ensure that they are good candidates for the technology. I think the way to to look at any, you know, program in its infancy like this is that, you know, early on, we anticipate a smaller percentage of individuals will go through the process, maybe, you know, 5%, and then, you know, longer term, we see this as, you know, in the 10% range as a general rule of thumb, you know, around this. There's, you know, it will be... You know, certainly it will reveal itself more as we start to work through the program.

Okay. And is that kind of 5% to 10% driven by more by new SEIs happening and more of the patients getting the personal access to skeletons? shortly after their injury rather than, you know, maybe they've had an SCI for 20 years, 5 years, 10 years, whatever it might be?

It's really a combination. You know, there are things like, you know, bone density and, you know, cardiovascular health and, you know, there's a number of elements that actually go into it. And no two individuals with spinal cord injuries are alike. I mean, you could have someone who's had an injury for a long period of time, but they've also done a lot to stay active. It really is driven on a case-by-case basis. But we have, you know, in working with our healthcare providers, we've provided good guidelines that can be used to help determine who's a candidate for the technology.

Okay, got it. And lastly, just to follow up on that, on those folks that, you know, may not fit the bill in terms of cardiovascular health or bone density, is that kind of a set number of new occurrences where, you know, 20% just right off the top, they're never going to qualify, or is there some certain X percent that... there's just absolutely no shot at?

Well, you know, again, I think, Ben, I'm not a medical expert in terms of that, but the guidance that, you know, the general information that we've received over the years is that, yes, I mean, there is a certain portion of the of the SCI population that absolutely, you know, just as, you know, where the technology is just are not candidates for, you know, for any of it. We need to make sure that, you know, whomever is doing this, that there is not a chance that it's going to injure them in any way. Patient safety is first and foremost. in our minds and in the minds of their healthcare providers. So again, our arduous screening processes that have been developed, and we developed these through the VA program that's been around for multiple years. This has managed to get quite a number of vets into the technology and also maintain a high degree of safety. So we're really relying on the healthcare providers providers and to ensure that we're maintaining that high level of safety, but putting the most people possible into the program where this technology could potentially help them.

Okay. Makes sense. That's it for me. Thanks for taking the questions, gentlemen, and good luck with CMS.

Appreciate it, Ben. Thank you.

Thank you. There are no further questions at this time. I'll turn the floor back to Scott Davis for closing remarks. Thank you. Right.

Thank you, Diego. And thanks to everyone joining us today. Overall, 2023 was a momentous year for exobionics, highlighted by record revenue growth. For our exo health business, our go-to-market strategy enabled us to drive more multi-unit orders from network operators that helped us achieve our strong revenue growth and improve our operating leverage. Now that we've added GateCoach software to ExoNR devices, we're addressing patient rehab needs by bringing these latest innovations to our Exoskeleton devices. From an operations perspective, we continue to optimize our expense and inventory management processes, which are being designed to enable us to scale our business and grow more efficiently. Looking forward, we're optimistic about our 2024 business outlook. and are excited as we build upon the momentum that was generated in 2023. We're looking forward to providing updates on our continued progress, and we thank you all for joining us today. Have a great day.

Thank you. This concludes today's conference. All parties may disconnect.