Ekso Bionics - Q2 2024

Transcript

Operator (participant)

Thank you for your patience. Apologies that you were experiencing some technical difficulties on our end. Thank you so much for waiting. Good evening, and welcome to the Ekso Bionics Q2 2024 Financial Results Call. At this time, all participants are on a listen-only mode. A brief question-and-answer session will follow the 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, with FINN Partners. Thank you, Matt. You may begin.

Matt Steinberg (Partner)

Thank you, operator, and thank you all for participating in today's call. Joining me from Ekso Bionics are Scott Davis, Chief Executive Officer, and Jerome Wong, Chief Financial Officer. Earlier today, Ekso Bionics released financial results for the quarter ending June 30, 2024. 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 this call that includes 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. These 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 operating expectations, or 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 Ekso's businesses, please see its filings with the Securities and Exchange Commission. Ekso 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 Ekso Bionics' Chief Executive Officer, Scott Davis.

Scott Davis (CEO)

Thank you, Matt. We kicked off the second quarter on a positive note with our at-home Ekso Indego Personal device receiving a payment decision from CMS for lump sum Medicare reimbursement, and continued the momentum throughout the quarter by generating record quarterly sales in our EksoHealth segment. We're pleased with the progress and even more excited about the potential of bringing our innovative robotic exoskeleton devices to more patients across the continuum of care, from the clinic to the home. As initial claims for reimbursement have been submitted for the Ekso Indego Personal, and as we have gained momentum in working with our current customer base to make this potentially life-changing technology available to more individuals living with an SCI, we remain encouraged by the possibility of meeting this multi-billion dollar personal mobility health addressable market in the U.S.

I'll touch more on this major development shortly, but first, I'll share an overview of our second quarter performance. We generated record quarterly sales of $5 million and sold 37 EksoHealth devices in the second quarter of 2024. Performance in the quarter was driven by continued growth in our enterprise health business, which is comprised of our EksoNR and our Ekso therapy devices. We believe our growing worldwide network of leading neurorehabilitation centers continues to recognize the clinical and economic value of our innovative EksoNR. Today, there are EksoNR devices at nine of the top ten rehab centers in the U.S., which we believe is an indicator that EksoNR is becoming the standard of care for lower extremity neurorehabilitation.

We believe we are well positioned to build upon this momentum and drive growth for both our EksoNR and our Ekso Indego therapy devices, as we continue to strengthen our distribution network and deepen our pipeline of opportunities. While we're pleased with the quarterly sales volume of the EksoHealth devices, U.S. sales were slightly affected by typical fluctuations in procurement cycles for our larger integrated delivery network or IDN customers. We anticipate these cycles leveling out later this year. In spite of these challenges, we maintained strong sales to individual clinics and hospitals and expanded our global customer base, which is a testament to the dedicated efforts of our global commercial teams. Internationally, demand remains strong, mirroring our robust performance in the first quarter. Notably, our pace in the EMEA region was driven by adoption of robotics within neurorehabilitation programs by the French public health system.

Sales in Asia also contributed to our international growth, with multiple orders for Ekso Indego Therapy, as neurorehabilitation centers in the region are adopting our potentially life-changing technology for individuals with lower extremity impairments. Not only did we place more devices globally, but we also expanded our international distribution network, which enabled us to gain greater operating leverage abroad. Looking ahead, we remain focused on continued development of our relationships with IDNs to secure larger multi-unit capital deals across North America as an initiative that is integral to our ongoing commercial strategy aimed at expanding our market footprint. We are optimistic about future prospects and our pipeline of potential deals. Now turning to an Ekso Indego Personal update.

We previously announced CMS confirmation that Healthcare Common Procedure Coding System, or HCPCS code K1007, falls under Medicare's brace benefit category and should be used to bill Medicare for the Ekso Indego Personal. At the start of the second quarter, CMS established a Medicare reimbursement level of $91,031. With pricing determination in place and initial claims pending reimbursement, we have achieved an important milestone that we expect will now enable us to significantly expand access to the thousands of Medicare and Medicaid-covered individuals living with a spinal cord injury. We believe these individuals now have the potential to achieve improved health and new levels of independence through the use of our Ekso Indego Personal in their daily lives.

This is just the beginning of what we view as a possible inflection point in expanding access to our potentially transformative technology for individuals who can most benefit from its daily use. As part of our scalable go-to-market strategy to drive patient engagement, we've been collaborating with our large network of neurorehabilitation centers throughout the country to facilitate patient screening and begin training and onboarding individuals so they can use the Ekso Indego Personal at home and in community settings. Additionally, we are conducting educational webinars featuring end users to showcase how they integrate the Ekso Indego Personal into their daily lives. We invite you to view these inspiring stories on our social media channels, including Facebook, LinkedIn, and X.

Early demand trends resulting from Medicare CMS reimbursement of the Ekso Indego Personal are promising, as evidenced by the increasing traffic through our website and growing pipeline of interest from individuals currently living with an SCI. These potential users are learning firsthand about the Ekso Indego Personal's purposeful design and how it can offer them potentially life-changing benefits in their daily lives. Moving forward, we are increasing our content marketing efforts, leveraging patient testimonials, and continuing to educate potential users, therapists, and clinicians on the device's potentially life-changing mobility benefits. We believe these initiatives have been crucial in driving further interest and adoption in the market, and we are thrilled that our differentiated exoskeleton devices are now accessible to a larger patient population. We are committed to ensuring that more qualified individuals can gain access to the Indego personal and are bullish on the potentially robust growth opportunity.

We look forward to providing updates on our continued work with the SCI community and future possibilities of adoption from individuals with neurologic conditions who could potentially benefit from our technology. Now I'd like to turn to an update on our industrial segment, EksoWorks. During the quarter, device revenue increased by approximately $150,000 from the same period a year ago, as we shipped the bulk of EVOs internationally. These shipments include a large pace supplier in Germany and a distribution partner in Korea. We are working to continue to raise awareness of the benefits that EVO provides for workers with strenuous overhead jobs, such as reduced fatigue, increased productivity, and a lower frequency of workplace injuries. EVO fits into a variety of industries, including automotive, aerospace, construction, and renewable energy, with multiple additional vertical segments possible where overhead work is required.

As we look ahead, we believe that Ekso is a pioneer in this nascent market and that we are poised to take a great share by continuing to target customers who could drive potentially large volumes of EVO devices in their various industrial segments. Turning to our operations, we remain focused on achieving positive cash flow through scaling our top-line growth while continually gaining operating efficiencies. Over the past year, under the leadership of Jason Jones, our Chief Operating Officer, we have worked to bolster our operating leverage while enhancing our inventory management. As Jerome will detail shortly, these initiatives helped us increase our gross margins in the second quarter by 500 basis points compared to the second quarter of 2023.

We believe that our disciplined approach to spending, combined with our improved operating efficiencies and scalable strategy, have us on the right path as we work to generate positive cash flow. In summary, it was a significant quarter for Ekso Bionics, highlighted by key CMS accomplishments for our Ekso Indego Personal device and continued execution of our commercial strategy that resulted in a record sales quarter. With a product portfolio that now potentially offers a broad reach to a significantly larger addressed end market across the continuum of patient care, we believe we are well positioned for future growth. At this time, I'd like to turn the call over to our Chief Financial Officer, Jerome Wong, to review our second quarter financial results.

Jerome Wong (CFO)

Thank you, Scott. We generated record quarterly sales of $5 million in the second quarter of 2024, compared to $4.7 million for the second quarter of 2023. Gross profit for the second quarter of 2024 was 2.6 million dollars, representing a gross margin of approximately 52%, compared to gross profit of $2.3 million in the second quarter of 2023, representing a gross margin of 48%. The increase in gross margin was primarily due to an increase in the average selling price for the EksoNR and lower EksoHealth device and service costs. Operating expenses for the second quarter of 2024 were $5 million, compared to $6.5 million for the second quarter of 2023.

The decrease was primarily due to lower general and administrative expenses, due to lower headcount, discretionary payroll, consultants, and labor costs.

Net loss applicable to common stockholders for the second quarter was $2.4 million, or $0.13 per basic and diluted share, compared to a net loss of $2.2 million, or $0.31 per basic and diluted share for the same period of 2023. Now turning to our financial results for the first half of 2024. Revenue was $8.7 million for the six months ended June 30th, 2024, compared to $8.8 million for the same period in 2023. We sold a total of 66 EksoHealth devices in the first half of 2024.

Gross profit for the six months ended June 30, 2024, was $4.6 million, representing a gross margin of approximately 53%, compared to gross profit of $6.3 million for the same period in 2023, representing a gross margin of 48%. The increase in gross margin was primarily due to an increase in the average selling price for the EksoNR and lower EksoHealth device and service costs. Operating expenses for the first half of 2024 are $10.2 million, compared to $13 million for the same period of 2023. The decrease was primarily due to the absence of costs associated with the acquisition and integration of the Human Motion and Control business unit from Parker-Hannifin in the comparable period, and lower discretionary payroll, consultant, and legal costs.

Net loss applicable to common stockholders for the six months ended June 30, 2024, was $5.8 million, or $0.33 per basic and diluted share, compared to a net loss of $8.6 million or $0.64 per basic and diluted share for the same period in 2023. Cash and restricted cash as of June 30, 2024, was $5.9 million, compared to $8.6 million as of December 31, 2023. Please see our quarterly report on a Form 10-Q filed earlier today for further details regarding the quarter. Operator, you may now open the line for questions.

Operator (participant)

Thank you. We will now proceed to the question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment please while we call for questions. Thank you. Our first question comes from the line of Ben Haynor with Lake Street Capital Markets. Please proceed with your question.

Ben Haynor (Senior Research Analyst)

Good day, gentlemen. Thanks for taking the questions. First off, for me, just on the, the interest pipeline that you're getting from, for Indego Personal, where is that materializing from? Is that, mostly individuals contacting you guys directly? Is it, clinics getting patients your way? Where is that coming from?

Scott Davis (CEO)

So good afternoon, Ben. Thank you for your question. So it's coming from a variety of places. We have individuals who are coming directly to our website, who have either seen our social media or, you know, have found information about this technology through their physicians or clinics. They would come to us and ask questions and find out about it directly. So we see a constant flow of individuals living with a spinal cord injury who are asking those questions of us. In addition to that, we have had numerous individuals that have come through clinics or existing customers that we work with already.

We have had calls directly from either the centers themselves or from physicians who have contacted us for additional information as they have patients who are interested in this technology. So, the summary is we're seeing interest coming in directly from individuals with a spinal cord injury, from CTs and clinics that are associated with our NR programs and also through physicians.

Ben Haynor (Senior Research Analyst)

Is there... You know, proportionally, is it, you know, 50/50? You know, 70 individuals, 30% clinics. Is there any way you could characterize that sort of proportionality?

Scott Davis (CEO)

Yeah, I think today we're seeing it's really a relatively even mix, you know, across it. You know, I don't have in front of me the details on exactly what the mix is, but to me, looking at it, it feels like it's about a 50/50 mix to us as we review it.

Ben Haynor (Senior Research Analyst)

Okay, fair enough. And do you expect that to change over time? I know you, you mentioned doing the investments in content marketing, you know, existing patients, webinars and such. But are there changes that you foresee develop or-?

Scott Davis (CEO)

... Yeah, there's almost a direct correlation. You know, as we go out and we do a webinar, you know, we get a significant amount of interest through the webinar, both from the healthcare community, as well as from individuals who may have joined the webinar. As we do individual campaigns with centers that we're working with, again, that whole, you know, individuals typically they'll end up either contacting us or the center, depending on how we've set up the marketing for it. But, generally speaking, every time we put some information out, we get, you know, we tend to get an influx of leads based on that campaign or webinar. So, today, it's really, you know, following that.

I think longer term, as there's more individuals who are familiar with the technology, you know, we're starting to see a little bit of a grassroots effort, you know, through social media, that is ramping up.

Ben Haynor (Senior Research Analyst)

Okay, got it. That's most helpful color. And then it looks like you made some nice progress on expenses, both gross margin-wise and operating expense-wise. Was there any drag in the quarter from Indego Personal units that you shipped out and had to recognize the costs but weren't able to recognize the revenue during the quarter?

Scott Davis (CEO)

No. Nope, they were. You know, we were able to. All the devices that we shipped in the quarter, we were able to recognize revenue on.

Ben Haynor (Senior Research Analyst)

Okay, got it. And how many Indego Personal units have been delivered to the CMS, precision?

Scott Davis (CEO)

So, as of today, we're not, you know, reporting that specifically or reporting that information. But I can tell you that, you know, our first handful of claims were submitted in Q2 and have advanced through the process to a pending status. We've also had, you know, an increase in our pipeline of individuals who are in varying stages of the process with new claims being submitted on a semi-regular basis.

Ben Haynor (Senior Research Analyst)

Okay, got it. Well, thanks for taking the questions, gentlemen, and congrats on the progress.

Scott Davis (CEO)

Appreciate it, Ben. Thank you.

Operator (participant)

Thank you. Our next question comes from the line of Li Chen with JPMorgan. Please proceed with your question.

Li Chen (Audit Director)

Hello, this is Li Chen in for R.C. I have one question regarding, regarding the insurance product. So based on your visibility of the current volume of inquiries from patients and centers, can you give us a sense of when the revenue in this stream can become meaningful? Just for curious about your thoughts. Thank you.

Scott Davis (CEO)

Yeah. Li Chen, thank you very much. Appreciate your question. So, you know, this is, yeah, this is a new, you know, a new program, new process. Payment determination was granted on April eleventh of this year, and we've been hard at work, ramping up a scalable process that allows us to reach more individuals with spinal cord injuries. And do this through a, you know, a methodology that leverages our 260+ neuro rehab clinics around the U.S. for, you know, onboarding and training. So, we are... We have been hard at work in this process within Q2, which is again, this past quarter was the first quarter that reimbursement was possible.

We were able to get our first handful of claims submitted and are progressing through the program. You know, the way that we looked at the program starting up, remember, we had a... You know, our basis has really been in on the enterprise health side of the business, and the bulk of our revenue has historically been generated from that. However, that being said, we are expecting and have belief that in the coming quarters we'll see an increasing number of Indego personal devices coming through the CMS reimbursement process.

So starting with, you know, a handful in Q2, as we expand into Q3, we have belief and pipeline to support, you know, a significant increase in the number that we have. So going from a handful to a couple handfuls to, you know, doubling that again, as we move into Q4. And in 2025, we believe that there will be a significant, that the Indego next Indego Personal will have a significant positive impact on our revenue in 2025 and growing beyond that. This, you know, this segment represents approximately a $2 billion funded addressable market.

You know, we're building a scalable process to be able to access that and find an efficient way to get this technology in the hands of the individuals who can use it.

Li Chen (Audit Director)

Thank you for color.

Scott Davis (CEO)

Thank you, Li Chen.

Operator (participant)

Thank you. There are no further questions at this time. I'd like to turn the floor back over to Scott Davis for closing comments.

Scott Davis (CEO)

Thank you, Alicia, and thank you to everyone joining us today. Since our acquisition of the Indego product line, we've made advancements in bringing our innovative wearable robotics to more patients and individuals who can potentially benefit from them. Now, with CMS coding and payment in place for the Ekso Indego Personal, and with the first claims having been submitted, we're excited about the prospects of bringing this technology to the larger SCI patient population. We believe our scalable go-to-market strategy will further establish Ekso as a major presence at leading neurorehabilitation centers, thereby elevating engagement levels with more individuals in need. At the same time, we've built a strong foundation for our EksoNR and Ekso Indego Therapy devices at post-acute care and outpatient neuro rehab centers, respectively.

As a result of our scalable commercial strategy, we closed the quarter with record sales and created a strong pipeline of future placements. Moving forward, we are enthusiastic about building upon these achievements and maintaining our commercial growth momentum. We look forward to providing updates on our continued progress. Thank you, and have a great day.

Operator (participant)

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