Ekso Bionics - Q3 2024

Transcript

Operator (participant)

Greetings, and welcome to the Ekso Bionics Quarter Three 2024 Financial Results Call. 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, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Matt Steinberg, FINN Partners. Thank you. You may begin.

Matt Steinberg (Partner of Investor Relations)

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 ended September thirtieth, twenty twenty-four. 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 facts should be deemed to be forward-looking statements.

All forward-looking statements include 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 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. The third quarter reflected a period of transition and progress, particularly within our personal line of Ekso Health devices. Notably, in August, the approval and reimbursement of the initial CMS claim for our Ekso Indego Personal represented a significant milestone for Ekso and importantly, patients with spinal cord injuries. After CMS established pricing determination for our Ekso Indego Personal in April, we immediately executed our field communication strategy to ensure that all targeted healthcare providers were made aware of the new CMS access and coverage policy that could impact thousands of Medicare and Medicaid patients living with a spinal cord injury. Additionally, we've been working closely with our extensive network of neurorehabilitation centers across the country, focused on education efforts on appropriate patient selection, screening, trialing, onboarding, and skills training for patients prescribed an Ekso Indego Personal for both at home and in community settings.

I also want to highlight the success we've had with investing in various digital marketing programs and strategies designed to raise product and policy awareness, which have resulted in an influx of new qualified leads. Additionally, we continue to develop and evolve our educational access resources to support prescribing healthcare providers in navigating through the insurance process efficiently and effectively. We remain committed to enhancing our collaboration with healthcare providers by ensuring that our innovative solutions meet their needs and by streamlining our processes with their feedback. I want to emphasize that this is a program that takes time to build. We're excited to see that across all targeted sectors, our pipeline is steadily increasing, which we believe will enable us to scale this program over time.

With multiple claims now submitted through our DME to Medicare, we will continue to focus our efforts on continued customer education to improve process efficiencies. We are actively engaging with new potential customers. This not only enhances our understanding of their needs, but also allows us to showcase the benefits of the Ekso Indego Personal device. We are committed to expanding access to our innovative Ekso Indego Personal technology and empowering more qualified individuals to achieve greater mobility and independence. We look forward to providing updates on our continued work with the SCI community and eventually individuals with neurological conditions who could potentially benefit from our technology once we're able to obtain the necessary indications. Now I'll share an overview of our third quarter performance. We generated quarterly sales of $4.1 million and sold 33 Ekso Health devices in the third quarter of 2024.

U.S. sales were affected by fluctuations in procurement cycles for our integrated delivery network, or IDN customers, that have persisted since the start of twenty twenty-four. This was compounded by several customers delaying capital purchases into the fourth quarter and into early twenty twenty-five. However, our demand and pipeline for Ekso Health products remain strong, and we're focused on delivering our innovative devices to individual clinics and hospitals while expanding our global customer base. We believe our expanding network of leading neurorehabilitation centers recognizes the clinical and economic benefits of our innovative EksoNR device. Currently, EksoNRs are deployed in nine of the top 10 rehabilitation centers in the United States, which we believe is an indicator that our technology is becoming a standard of care for lower extremity neurorehabilitation. We plan to leverage our strong reputation to drive growth for both our EksoNR and our Ekso Indego Therapy devices.

As we continue to strengthen our distribution network and expand our pipeline of opportunities, we remain confident in our ability to grow our presence among neurorehabilitation centers and enhance patient outcomes. Internationally, demand remains strong, mirroring our robust performance in the first half of the year. Sales in Europe achieved record levels in the quarter, as neurorehabilitation centers in the region are adopting our potentially life-changing technology. In addition to placing more devices worldwide, we also expanded our international distribution network, which has allowed us to achieve greater operating leverage in foreign markets, which we believe positions us well for continued success on a global scale. As we look ahead, we are committed to further developing our relationships with our IDNs to secure larger multi-unit capital contracts across North America.

This initiative is a key component of our ongoing commercial strategy to expand our market presence, and we are optimistic about our future prospects in the growing pipeline of potential deals. Now, I'd like to provide a brief update on our industrial segment, EksoWorks. In the third quarter, sales of Ekso's EVO exoskeleton were impacted by labor strikes in U.S. manufacturing industries. Nonetheless, we are committed to raising awareness about the benefits that EVO offers for workers engaged in demanding overhead tasks, including reduced fatigue, increased productivity, and fewer workplace injuries. EVO is suitable for a range of industries, notably in automotive, aerospace, construction, and renewable energy verticals, and numerous other sectors where overhead work is necessary. Now shifting to our operations, where we continue to create more efficiencies throughout our business.

Our improvements in supply chain and inventory management, along with efficiencies gained in production, resulted in strong gross margins for the quarter, despite a concentration of our revenue being sold in Europe, which reflected lower ASPs, as is typical with distribution. Overall, we are pleased to have improved our operating margins in the quarter by reducing our operating expenses. In summary, this was a quarter of progress for Ekso Bionics, marked by the receipt of initial CMS claims reimbursement for our Ekso Indego Personal and increased global demand for EksoNR. With our total product portfolio that has the potential to reach a large addressable market in excess of $13 billion across the continuum of care, we believe we are trending in the right direction for future growth.

At this time, I'd like to turn the call over to our Chief Financial Officer, Jerome Wong, to review our third quarter financial results.

Jerome Wong (CFO)

Thank you, Scott. We generated quarterly sales of $4.1 million in the third quarter of 2024, compared to $4.6 million for the third quarter of 2023. Gross profit for the third quarter of 2024 was $2.2 million, representing a gross margin of approximately 53.5%, compared to gross margin of 53.3% in the third quarter of 2023. The increase in gross margin was primarily driven by cost savings in supply chain and a reduction in service costs, partially offset by lower margin sales related to increased volume through distribution. Operating expenses for the third quarter of 2024 were $4.8 million, compared to $5.4 million for the third quarter of 2023. The decrease was primarily due to lower headcount, discretionary payroll, and consulting costs.

Net loss applicable to common stockholders for the third quarter decreased to $2.1 million, or $0.10 per basic and diluted share, from a net loss of $3.4 million, or $0.24 per basic and diluted share, for the same period in 2023. Now, turning to our financial results for the first nine months of 2024. Revenue was $12.8 million for the nine months ended September thirtieth, 2024, compared to $13.4 million for the same period in 2023. We sold a total of 99 Ekso Health devices in the first nine months of 2024.

Gross profit for the nine months ended September 30, 2024, was $6.8 million, representing a gross margin of approximately 53%, compared to a gross margin of 50% in the third quarter of 2023. The increase in gross margin was primarily driven by cost savings and supply chain and a reduction in service costs, partially offset by lower margin sales related to increased volume through distribution. Operating expenses for the nine months ended September 30, 2024, were $15 million, compared to $18.4 million for the same period in 2023. The decrease was primarily due to lower headcount, discretionary payroll, accounting, consulting, and legal costs.

Net loss applicable to common stockholders for the nine months ended September 30th, 2024, was $7.9 million, or $0.42 per basic and diluted share, compared to a net loss of $12 million, or $0.88 per basic and diluted share, for the same period in 2023. Cash and restricted cash as of September 30th, 2024, was $8.3 million, compared to $8.6 million as of December 31st, 2023. In September, we closed an underwritten public offering, resulting in net proceeds of approximately $5 million. Please see our quarterly report on 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 be conducting a question and answer session. If you'd 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 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up a handset before pressing the star keys. One moment while we poll for questions. And our first question comes from RK, H.C. Wainwright.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Good afternoon, Scott, and Jerome.

Scott Davis (CEO)

Hey, RK.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Few questions from me. So it's good to see that you had 33 placements during the quarter. I'd like to know, of these 33 placements, how many of them were ex-US? Because you're saying that the ex-US geographies are doing pretty good.

Scott Davis (CEO)

Yeah, correct. Approximately half of those were in Europe and several of them in APAC. So I would say the majority of those placements were outside of US. And, you know, within, you know, those devices we had, in terms of revenue, we had about 20% of revenue that was reflected by the personal product.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Okay, perfect. And then, in terms of client claims that you filed with CMS, you were saying that you're pretty much caught up with terms of filing. So, is there a way you can give us the number in terms of how many have been filed and what % of those filed have been reimbursed at?

Scott Davis (CEO)

Sure. You know, on the personal devices, I can give you a sense of this. We've submitted multiple claims, you know, year to date, the majority of which happened in the third quarter, and to date, our DME partner has received reimbursement on one claim. We've had two claims that have come back and required additional information for resubmittal, but in general, we almost doubled the sales of personal health products from Q2 to Q3, and you know, we believe, you know, today that represents, as I said, about 20% of our sales for the quarter. I will say that, you know, the claims that we are submitting are taking some time to move through the reimbursement process.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Okay. And then, the last question from me is regarding the buying cycles of some of your customers. You were saying that some of the folks have been pushing, and they're buying into fourth quarter of this year and first quarter of 2025. So based on what you're seeing, what do you think is generally the backlog now, in the sense that you have a lead but has not been filled because of their pushback? And, you know, is there a way for us to kind of figure out, you know, how that backlog is getting taken care of?

Scott Davis (CEO)

Yeah. In terms of backlog, we have ordered backlog that is, you know, on the books right now for Q4. You know, I think the way to think about this is that, you know, we have continued strong demand in Europe and as it relates to North America, you know, this has been a bit of an off-cycle year for us with our IDNs. We had very strong sales in 2022 and 2023 relative to our IDN procurements, and 2024 remains impacted by being slightly off cycle with these customers in North America.

However, we do believe that we're coming around again to renewal cycles, which we anticipate will positively impact us in 2025 and in Q4 as well. So, you know, we have strong pipeline and demand which supports future growth on our enterprise segment as well as in our personal segment.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Okay.

Scott Davis (CEO)

I'm not sure that's a full answer.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Thanks for taking all my questions.

Scott Davis (CEO)

Yep, you bet. Thank you.

Operator (participant)

Thank you. Our next question comes from Ben Haynor, Lake Street Capital.

Ben Haynor (Senior Research Analyst)

Good afternoon, gentlemen. Thanks for taking the questions. First off, for me, just following up on the IDNs. Have there been any? I know you mentioned it off, being off cycle, but has there been any distraction for any reason due to the CMS reimbursement for the personal units? I mean, have folks waited and tried to take a look at maybe adding some Indegos to the clinics or anything like that? Are there any dynamics at play related to the personal units?

Scott Davis (CEO)

Yeah, that's a great question. You know, in general, I would say the issue really isn't so much around distraction, you know, as it is, you know, a lot of these enterprise accounts are lumpy, and we had absolute record sales in North America in 2023. We're having absolute record sales in Europe this year. So, you know, some of this is just, you know, really following procurement cycles. We have, you know, certainly in Q3 in North America, we had, you know, multiple customers on the enterprise side that made the decision to delay their purchases to either Q4 or into 2025.

You know, just citing, you know, some uncertainties, sort of macroeconomic uncertainties that they had, you know, perhaps even relative to politics.

Ben Haynor (Senior Research Analyst)

Sure. That makes sense. And then, you know, Europe obviously is a bright spot here. How much insight do you have into how the remainder of the year could look, on that front? You know, should we expect international to be as strong in Q4 as it was in Q3, or what's the right way to think about that, to the extent you could share?

Scott Davis (CEO)

Yeah. Demand in Europe remains strong for us. We've also accumulated a solid backlog coming into the quarter there. So as we look at Europe in Q4, we believe that we will once again have a strong quarter there.

Ben Haynor (Senior Research Analyst)

Okay, so you don't have, like, a clear backlog entering Q4. It's just as strong as it was maybe entering Q3.

Scott Davis (CEO)

Yeah, we, you know, I'll say that we have, you know, coming into the quarter, we had at the end of Q3, we had more than a dozen devices in backlog at the end of Q3.

Ben Haynor (Senior Research Analyst)

Okay, great. That's helpful. And then on the label expansion that you mentioned earlier, into more neurological conditions, you know, is there anything that investors should be on the lookout for there? Is there, you know, kind of a timeline that you could speak to on any of these things?

Scott Davis (CEO)

Yeah, nothing definitive yet, but I will say that Ekso has a history of working very closely with some of the top neurological research hospitals and facilities in North America and throughout the world. And, you know, our clinical studies, which can often be quite expensive, particularly when you're looking at, you know, new FDA indications for use, we have been able to leverage those long-standing relationships with those centers. And with the new personal products, with our Indego family of products, we've had significant interest from those research hospitals to engage in those studies, to potentially expand indication for use for our Indego family of exoskeletons. So this is something that we are working on currently.

You know, the timeframe on these sorts of endeavors is somewhat undefined, but you know, it certainly takes some time to be able to do this. We're lucky to have partners who can help us, because it really helps us to contain the expenses that are related to you know, gaining those clinical trials.

Ben Haynor (Senior Research Analyst)

Okay, got it. And then lastly, for me, just one point of clarification. You said 20% of the revenue was the personal product. I'm not sure if I caught that. Was that overall, or was that for specifically the U.S. or international or any carve-out there?

Scott Davis (CEO)

Yeah, so in general, you know, our top line total revenue for the quarter, approximately 20% of that was directly related to our personal products.

Ben Haynor (Senior Research Analyst)

Got it. Okay, that's all I had, gentlemen. Thanks for taking the questions.

Scott Davis (CEO)

You bet. Thank you, Ben.

Operator (participant)

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

Scott Davis (CEO)

Okay. Thank you, Julian, and thank you to everyone for joining us today. In closing, we are pleased with the progress we made this quarter and the strides that we've made on both the reimbursement and the operational fronts. While we recognize that there is still work to be done, the initial reimbursement approval for our Ekso Indego Personal device marks an important milestone for us and the SCI community, enabling access for covered individuals at a fraction of the cost. We believe our ongoing collaboration with physicians and neurorehabilitation centers is vital to our success, and we are committed to providing the resources and educational support necessary to drive patient engagement. We believe that as more physicians become advocates for our devices, we will see a corresponding increase in submissions and approvals.

In terms of our enterprise customers, we're optimistic about the future as procurement cycles with IDNs normalize in the near term. We remain focused on collaborating with our partners to ensure that we can meet demand and capitalize on the opportunities ahead. As we continue to expand our reach, we believe we are well equipped for sustainable growth ahead, and as a result of our scalable commercial strategy, we closed the quarter with a strong pipeline of future placements. Moving forward, we're enthusiastic about building upon this progress. Thank you for your continued support, and we look forward to updating you on our progress in the coming quarters.

Operator (participant)

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