NASDAQ:LFWD ReWalk Robotics Q1 2023 Earnings Report $1.41 +0.02 (+1.44%) Closing price 05/2/2025 04:00 PM EasternExtended Trading$1.42 +0.01 (+0.35%) As of 05/2/2025 07:56 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast ReWalk Robotics EPS ResultsActual EPS-$0.49Consensus EPS -$0.56Beat/MissBeat by +$0.07One Year Ago EPSN/AReWalk Robotics Revenue ResultsActual Revenue$1.23 millionExpected Revenue$2.00 millionBeat/MissMissed by -$770.00 thousandYoY Revenue GrowthN/AReWalk Robotics Announcement DetailsQuarterQ1 2023Date5/11/2023TimeN/AConference Call DateThursday, May 11, 2023Conference Call Time8:30AM ETUpcoming EarningsReWalk Robotics' Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled on Wednesday, May 14, 2025 at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by ReWalk Robotics Q1 2023 Earnings Call TranscriptProvided by QuartrMay 11, 2023 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Good morning, and welcome to the ReWalk Robotics First Quarter 2023 Earnings Conference Call. All participants will be in a listen only mode for the duration of the call. Please note that this event is being recorded today. I would now like to turn the conference over to Chief Financial Officer, Mike Lawlis. Please go ahead, sir. Speaker 100:00:42Thanks, Joe. Good morning, and welcome to ReWalk Robotics' Q1 2020 earnings call. I'm Mike Lawless, ReWalk Robotics' Chief Financial Officer and with me on today's call is Larry Jasinski, ReWalk's Chief Executive Officer. Earlier this morning, ReWalk issued a press release detailing financial results for the 3 months ended March 31, 2023. The press release and a webcast of this call can be accessed through the Investor Relations section of the ReWalk website atrewalk.com. Speaker 100:01:12Before we get started, I'd like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance may be considered forward looking statements within the meaning of the Private Securities Litigation Reform Act. These forward looking statements are based on information available to ReWalk Management as of today and involve risks and uncertainties, including those noted in our press release and ReWalk's filings with the SEC. Such forward looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward looking statements. ReWalk specifically disclaims any intent or obligation to update these forward looking statements whether as a result of new information, future developments or otherwise, except as required by law. Speaker 100:02:03A replay will be available shortly after completion of the call accessible from the dial in information in today's press release. The archived webcast will be available in the Investor Relations section of the company's website. For the benefit of those who may be listening to the replay or the archived webcast, this call was held and recorded on May 11, 2023. Since that date, ReWalk may have made subsequent announcements related to topics discussed. So please reference the company's most recent financial most recent press releases and SEC filings for the most up to date information. Speaker 100:02:37With that, I'll turn the Speaker 200:02:38call over to Reebok's CEO, Larry Jasinski. Thanks, Mike. Welcome, everyone. We appreciate your time with us today. We achieved positive results in Q1 and specifically had continued progress on each of our major areas of focus to drive the business over the next 3 years. Speaker 200:02:57We are on track in all respects. The goals remain to move forward with the Centers for Medicare and Medicaid Services, CMS to rebuild our active case submission base post COVID with the acceptance of the state court ruling for direct supply in Germany to advance the design of the ReWalk personal exoskeleton to further improve the user experience and to identify additional product offerings to build our critical and strategic mass. Sales in Q1 were $1,230,000 in line with internal expectations and in line to support year over year growth driven over the second half of twenty twenty three. The United States has expanded cases with the VA and Germany had a significant increase in submissions in Q1, which will translate to improved second half twenty twenty three sales. Expenses were also in line with internal expectations. Speaker 200:04:00Mike will address this further in the financial results section. Our ongoing efforts with CMS to expand coverage of exoskeletons for Medicare beneficiaries is a key element of our strategic path and a defining point for the exoskeleton industry. We have gained widespread acceptance from SCI societies and key companies in this market. Creating a repeatable process to secure payment for the ReWalk device for Medicare beneficiaries is an essential priority for us. The Medicare SCI population is the largest population segment of individuals who could benefit from this technology and therefore our single largest potential market segment in our single largest potential market, the United States. Speaker 200:04:49The ReWalk personal exoskeleton is innovative. It has been designed as a breakthrough device by the FDA and was cleared through the de novo pathway. Being on the leading edge is both an opportunity and a challenge. The opportunity is that the value is recognized. There are lots of individuals in the federal agencies at the highest levels that are working to help ensure the device is available to patients. Speaker 200:05:15The challenge is that CMS and its local Medicare Administrative Contractors, MACs, haven't directly processed anything quite like this previously. So the process by which these claims are handled must be created to ensure that payment is consistent and timely. The reality is that implementing these new procedures can take time despite the support and guidance that we have continued to receive from leadership within CMS and the MAX. And the only way to refine this is to submit claims in order to test the process, to clarify what needs to be clarified and to fix what needs to be fixed. The good news is that we have made significant progress to this point. Speaker 200:05:58For this strategy, we submitted our 1st Medicare claim and in Q1, early Q2 has seen advancement and meaningful feedback on this claim. As we anticipated, the lack of an established process for submitting claims to the coverage of personal exoskeletons has presented issues that need to be addressed in order for the claim to be paid. We received questions on benefit category, documentation and pricing methodology. We even had some simple administrative challenges from Medicare's claims portal operations. Again, this was to be expected given that this is the first time an exoskeleton claim is moving through the Medicare process. Speaker 200:06:36Fortunately, both CMS and the MAC involved in this claim have engaged with us to move Claimant forward for this beneficiary. Importantly, no significant or insurmountable issues have been identified. Our strategy to submit one claim to start was purposeful. Based upon this experience, we are now ready to submit our next round of claims for additional patient beneficiaries. We aim to submit claims for approximately 10 additional SCI Medicare beneficiaries in Q2 and have received significant positive interest from many more SCI patients and their providers who will be in the queue to follow shortly. Speaker 200:07:17Overall, navigating a new category and process for payment is more tedious than any of us would like, but this is progressing in a meaningful manner. We have put a great team together to support this effort and we will be relentless because this truly is in the best interest of both patients and our healthcare system. I am confident that with the support we have received from both CMS leadership and the MAX involved, we will continue to make material progress one step at a time. At the same time, we are preparing for the future. We have built our organization to enable scaling of our efforts to manage a growing number of claims. Speaker 200:07:56This includes putting an experienced program manager in place, defining and implementing quality standards and operating procedures to operate as a CMS supplier and adding a medical director with a background in physical medicine and rehabilitation and in CMS claims oversight to help with our upcoming claims preparation. We have made progress on all of these initiatives. We will expand the structure further to support increased claims in 2024 2025. I am confident that the results of our efforts will positively shape the industry in the long term. To reiterate again, this is important because over half of all SCI patients are covered by Medicare and Medicaid within 5 years of injury. Speaker 200:08:42So the results of these initiatives will ultimately define beneficiary access to the only technology solution that makes it possible for them to stand, walk, ascend and descend stairs and perform activities of daily living in their home and community. We also have technical progress in parallel with the CMS MAC processes. On March 7, we announced the achievement of FDA clearance for our STAIRS enabled ReWalk personal exoskeleton. This FDA clearance broadens the ability for utilization of the system by removing limits that are a physical reality in areas where people want to walk. Examples are, visiting the home of friends or family where they have steps at the entry and no ramp, areas where there are no curb cutouts on city sidewalks, or using the front door of a business that has an accessible access around back. Speaker 200:09:35Expanding access to everyday walking in everyday environments is a major leap for those who are blocked from too many activities or locations. The design includes the software and controls to ascend or descend steps and curves and enhanced structural components of the ankle and thigh to further improve the robustness of the design. Our extreme example is Simon Kinleysides in England, who achieved a Guinness World Record last year after climbing 1444 steps in a 51 story building in one day, which shows the durability of the system. I congratulate him. Our real focus is everyday life and this FDA clearance offers increased opportunities to experience the benefits of walking in everyday environments even when those environments contain obstacles such as stairs or curbs. Speaker 200:10:29We remain active on a significant number of paths to increase our critical mass and develop long term strategic mass. We are actively seeking opportunities to grow our portfolio of solutions in neurorehabilitation both by way of acquisition and distribution partnerships. This growth will help to expand our relationships with customers and will enable new opportunities to scale our business in the broader neuro rehabilitation market. I'd now like to turn the call over to Mike for a review of the financial details. Mike? Speaker 100:10:59Thanks, Larry. As discussed during our last earnings call, the Q4 2022 performance reflected our success in converting near term opportunities in our pipeline to revenue. As a result, our focus during Q1 2023 was to continue to deliver revenue while adding to our commercial pipeline and lay the foundation for growth in 2023. For the Q1 of 2023, we accomplished both of these objectives with solid revenue and an improved pipeline. ReWalk reported revenue of $1,200,000 up $400,000 or 40% in the Q1 of 2023 as compared to $900,000 in the Q1 of 2022. Speaker 100:11:36This was in line with our internal budget and we remain on track to our internal growth targets for the fiscal year. The increase in revenue compared to Q1 'twenty two was a result of improved ReWalk sales performance in the U. S, partially offset by less traction in the EU. We also grew revenue from our distributed product line, the MyoCycle FES training cycles. In Q1 2023, revenue was over $200,000 up 14% versus revenue in Q1 2022. Speaker 100:12:07The sequential decline versus Q4 2022, we believe to be a result of the timing of trade shows and seasonal buying patterns of our customers. We expect to build sales volumes of Miocycles sequentially as we move through the rest of the year. Turning to our pipeline metrics within the current markets for the ReWalk product line, which includes individuals covered by the Veterans Administration or workers' compensation insurance in the U. S. And by private insurance in Germany, the current pipeline of active rentals consists of 18 cases, including 14 in Germany, 12 insurance and 2 South Pay and 4 VA rentals. Speaker 100:12:43Our overall number of cases in process is 71 with 53 in Germany and 14 in the U. S. As a reminder, these pipeline figures do not include cases that would be eligible for Medicare reimbursement since although we have established Medicare coverage, CMS CMS is still in the process of establishing a benefit category designation under which we can be reimbursed. If our progress with CMS successfully results in the establishment of an acceptable reimbursement mechanism and payment rate, we expect to add our list of already identified Medicare eligible patients for inclusion in our future pipeline figures. Moving to gross margin, in Q1 'twenty three, our gross profit was $571,000 or 46.4 percent of revenue, up 16 percentage points as compared to $265,000 or 30.3 percent of revenue in Q1 'twenty two. Speaker 100:13:35This increase in gross margin was primarily driven by several factors. The impact of higher revenue volumes leveraging our fixed production costs, higher average sales prices on the ReWalk devices and reduced freight and overhead expenses. Operating expenses in Q1 'twenty three were $4,900,000 up $400,000 or 9 percent as compared to $4,500,000 in Q1 'twenty two. Within the functions, R and D spending decreased by $200,000 or 17%, primarily due to lower spending and professional services due to the completion of the STAIRS project and the accomplishment of significant milestones on the ReWalk 7 project. Selling and marketing expenses increased $300,000 or 14%, primarily due to higher consulting fees associated with CMS reimbursement related activity and travel expenses. Speaker 100:14:28General and administrative expenses increased $200,000 or 17% due to higher employee related expenses and professional service fees, partially offset by lower insurance costs. Our net loss for the Q1 of 2023 was $4,300,000 or $0.07 per share as compared to a net loss of $4,400,000 or $0.07 per share in the Q1 of 2022. We ended the quarter with $61,900,000 of cash and equivalents and no debt. Our operating cash usage in Q1 was $4,900,000 which was a decrease from $5,500,000 in Q1 of 2022. However, this is an increase sequentially from Q4 'twenty two because the Q1 of each fiscal year is seasonally the highest quarter for cash consumption. Speaker 100:15:15The timing of annual payments for items such as insurance renewals as well as the payment of annual variable compensation typically occur in Q1. We expect quarterly operating cash usage to decline in Q2 and remain lower than Q1 level for the rest of 2023. We believe our cash balance provides us ample resources to fund the growth of our existing business, including our efforts to expand reimbursement coverage of the ReWalk device as well as to pursue attractive business development opportunities to acquire additional complementary products. We believe both of these investment areas are crucial for us to build scale and accelerate our path to profitability. During Q1 'twenty three, we repurchased approximately $771,000 of ReWalk ordinary shares. Speaker 100:16:05As you may recall, our initial 6 month authorization from the Israeli court for the repurchase program expired in January of this year. So we filed a motion with the court for permission to continue with repurchases for a second 6 month period, which the court approved. We created a new 10b5-1 plan for the 2nd 6 month period, which automatically repurchases shares when the criteria of the plan are met. Now I would like to briefly comment on our financial outlook for Q2, 2023 and the full year 2023. Based on the current pipeline for ReWalk Systems, we expect Q2 revenue to be similar to the level in Q1 of Q1 revenue with growth accelerating in the second half of the year. Speaker 100:16:45For the full year 2023, we anticipate revenue growth of approximately 15% to 20% versus the results in full year 2022. Importantly, these outlooks for Q2 and FY2023 do not include revenue from sales to Medicare eligible patients. While we will be shipping more ReWalk devices to users and submitting claims to Medicare during Q2, as Larry described, these transactions will not contribute to revenue until the MACs begin to process and pay claims. Until that process gets underway and we have visibility to the processing timetable and payment rates, we will continue to exclude the impact of potential Medicare payments from our financial outlook. With that, I'll turn the call back to Larry for further remarks. Speaker 100:17:30Thank you, Mike. Speaker 200:17:33We laid out our goals for 2023 at the start of the year and I on each of them after each quarter. To restate the goals, to achieve sales growth via our workman's compensation and VA activity in the United States along with more contracted insurers in Germany. Number 2, to expand our portfolio of products through distribution agreements or product line acquisitions and number 3, to leverage these activities to move towards breakeven profitable operations with our current capital. To measure our progress in Q1, I have 7 areas I would like to highlight. 1st, expansion of CMS case submissions. Speaker 200:18:16Our processes and infrastructure for qualifying and processing claims is operational to meet our goals in 2023. We added experienced talent in terms of preparing the pipeline for submissions, expanded clinical experience with recruiting a medical director with significant experience managing CMS claims, who is also a physical medicine and rehabilitation physician, typically noted as a PM and R physician or physiatrist with clinical experience treating spinal cord injury patients. Our interaction with the CMS and the MAX in Q1 has provided us a better opportunity to understand the structure and approach they recommend giving the newness of exoskeletons. We will submit 10 or more claims in Q2 with a target of submitting 35 to 50 Medicare claims for 2023. The information gained with claim 1 are key steps that support achieving our goal. Speaker 200:19:13We have now tested the system, identified the requirements and streamlined the claims process. Given these critical steps, we expect to have a repeatable system that will expand in 2024. Progress with establishing coverage for Medicare benefits is especially meaningful for this population as approximately 30% of U. S. Individuals spinal cord injury are covered under Medicare and another 25% are covered under Medicaid within 5 years after their injury. Speaker 200:19:422nd, expansion of VA training centers. We now have 5 active centers in the U. S. And our goal is to expand that by 5 or more over the remainder of the calendar year. We have new sites recruiting veterans, additional certification training scheduled and active discussions with 6 new centers present. Speaker 200:20:033rd, in Germany, we have now presented updates to DGUV and are scheduling discussions with additional groups for our direct supply contracts now that we have post the acceptance in Q4 of direct supply from the court proceedings. We were able to increase submissions in Q1 to a record level and those cases will impact revenue in Q3 and Q4. 4th, product acquisition. We recognize the operating value and financial efficiency of expanding to multiple adjacent product offerings. We have demonstrated success with our integration of distribution products. Speaker 200:20:43These considerations remain highly active and we report on these initiatives as they reach conclusions. 5th, data expansion. On May 9, at ISPORE, which is the Professional Society For Health Economics and Outcomes Research, had a publication titled Powered exoskeletons for personal use in the home and community may be associated with lower health resource utilization cost in veterans with SCI. This study compared outcomes with 31 exoskeleton users to 54 wheelchair only users. The results demonstrated that powered exoskeletons for personal use, PEP, may be associated with lower utilization cost in veterans with SCI. Speaker 200:21:30Also, a greater proportion of the exoskeleton group had lower health resource utilization cost the year after the prescription than the wheelchair only group. 6th, organic product improvement. The next advancement of the ReWalk system is nearing completion of late stage development and final preparations for FTE and CE submission. We expect to submit this newest design for FTE review and CE review in the second half of twenty twenty three. And 7th, financially, 2023 includes further investment to continue building the required reimbursement in health economic operational infrastructure to support Medicare, VA and private payers. Speaker 200:22:13Our Investor Relations program has increased resources now to communicate the breadth of activity. Our company slide deck has been updated to provide more information is now on our website. With the recent and pending milestones, we are now presenting at new investor conferences and with non deal ROADSHO activities with the help of our Investor Relations firm, LifeSci Advisors. In conclusion, our overall strategic direction continues to be building the core SCI product line as insurance access is more widely accepted. While in parallel, adding adjacent critical and strategic mass as a neuro rehabilitation technology and product consolidator. Speaker 200:22:58We understand and are seeking to complete this level of expansion and growth to achieve a breakeven profitable operation on our current capital. I also wish to thank our shareholders for their continued commitment in supporting these life changing technologies as we expand this business in 2023 2024. I look forward to providing further updates each quarter and through communication of each milestone achieved. I'd now like to answer any questions you may have. So operator, if you could open this up to our audience, we would appreciate that. Operator00:23:32We will now begin the question and answer And our first question here will come from Swayampakula Ramakanth with H. C. Wainwright. Please go ahead with your question. Speaker 300:24:08Thank you. This is RK from H. C. Wainwright. Good morning, Larry and Mike. Speaker 300:24:14I appreciate you doing this call. Certainly, this quarter seems to be pretty strong, started off on a good foot. In terms of submissions to the Germany workers' comp and other insurances that you're talking about. What do you think of the timing or is there anything that you can give us to see how soon the conversion could happen? Or do you see them going to be lumpy during the second quarter and the second half? Speaker 200:25:03This is Larry. I'll answer it first. We see that the record submissions and the number that we got in Q1 are likely to convert in Q3, Q4. Whether they occur in Q3 or Q4 is more variable, so there's a little bit of lumpiness to us. And then of course the submissions we get in here in Q2 would be more geared towards Q4. Speaker 200:25:25So the increase in submissions we're beginning to see on the positive side post COVID, we've got new interest. Our leads are back to pre COVID levels. Our limiters primarily have been the rehab centers are not still staffed at levels to where the dates at which we schedule the users are not as soon as we'd like tomorrow and they're giving us like a week after tomorrow. But other than that, they're progressing reasonably well. So the predicted timing for most of these is 6 to 9 months for a submission to translate to revenue. Speaker 300:26:04Perfect. On the CMS expansion, the reimbursement expansion, I mean, so can you give us a little bit more color as to why you're so confident that you learned enough from one case that you think the not only the smoothness of the submission, but also in terms of them processing the claims is going to be better as in either in the second quarter or in the second half? Speaker 200:26:51I'm going to answer that 2 ways. First, our confidence starts with our product. We absolutely and relentlessly will push this because the data is that good. And what I'm seeing at CMS is a recognition and not a challenge of that. This changes lives and CMS seems to want to take care of its beneficiaries. Speaker 200:27:12So a lot of that is in the data and the science is why we're confident. But there's a parallel element. They've chosen to interact with us. We have had a reasonable number of interactions, some of them inefficient. They couldn't answer things the way we wanted, but they work to help get things through. Speaker 200:27:30They've not given us anything that tells us they're going a different path. And we've certainly talked to them a fair amount in this process. And the advice of putting in additional cases is coming from CMS. Speaker 300:27:48And then as you said, since they are coming to you more than you running after them, does that mean the processing time is going to do you have any idea on the processing time just like what you talked about Germany being anywhere from 3 to 6 months or is it just too early to call it? Speaker 200:28:14I'm afraid it's just too early to call it. I described for them it's a brand new process too and they're trying to fit it in within rules and guidelines they have and this product is so innovative and unique it doesn't fit very well in their structure And that's been the biggest headache we've had so far. They've been trying to figure out where to put it and how to process it. And they part of them processing it the way they are now with the MAX is the MAX have a little more flexibility. And I think we'll see more structure built over time through CMS. Speaker 200:28:45But they haven't given us timelines. That's why it's not yet in our financials forecast. But we believe that's a function of us finishing the process. Speaker 300:28:56Okay. Regarding the VA training centers, VA is one organization that has seen this product for the longest of time. With COVID or basically no COVID at this point, so what are you seeing in terms of people getting trained and also them trying to speed up? Is there are there the same similar issues as in the German training centers in terms of people them having enough personnel to train and other such issues? Speaker 200:29:44That varies greatly by site. There are some sites that are well resourced and able to do it. And as we look at the newer centers, some of them are ones that are well resourced, so that's why they jumped in. The others have progressed towards a model of they'll still handle the patient, but they've used the community care networks, the CCNs, as a place to do the training, which has dealt with their staffing challenges. And that seems to be a formula of some of the other VAs like. Speaker 200:30:14The addition was somewhere we were at 3 in the past. We noted that they're now 5. So we've gone up by 2 since we last talked to you and we're looking at another 5. The coverage for these individuals will start to broaden. One of our other limits was we were really limited to a very small geographic area where the few centers were. Speaker 200:30:35As we get to 10, we'll have a greater geographic push and that will allow many of these people that have been waiting a path to get their exoskeleton. So the VA has reopened, but we want more of them opened. So getting these next five matters and if we're ending the year with at least 10 active centers, we're going to get to be able to fill the request of a large percentage of the ones that have been waiting over these past few years. Speaker 300:31:04Thank you. One last question from me is, so getting to use the exoskeleton to climb stairs, as you said, is certainly a huge benefit for some or all of the users. So how is that translating into potential patients trying to come in and say, now that you have it, so you have everything that I want, so can I get trained? That sort of the conversation. How much of that is increasing and what do you what are your comments on that end of things? Speaker 200:31:47The specific patients, they look at it as the more they can use this the better, the ones that are more favorable. And when you take away limitations, they are more favorable in the product. But I would generally say most of them are already favorable, and it was a matter of finding a way to get it paid for. So the CMS and VA coverage is going to get the majority of the audience. What this will really do is make it a better product for the beneficiaries of CMS and better product for the VA because the users will use it more. Speaker 200:32:17And that's what they really want. So that is the bigger value. It takes away obstacles, but it's generally so far taken away obstacles from people who already wanted it. Speaker 300:32:28Perfect. Thank you very much for taking all my questions. Operator00:32:41Our next question here will come from Martin Pawlick with KNCR. Please go ahead with your question. Speaker 400:32:49Good morning, gentlemen. Two questions, if you can hear me. I'd like to ask you first with regard to the commentary you provided, which was quite useful and helpful in terms of providing more transparency. That you've reserved for the conference call itself. In the past, you've actually done that, providing more clarity, going through those bullet points. Speaker 400:33:29I don't know what motivated you not to make any comments on that. But remember, not everybody is necessarily on this call. As we know, there's just a few investors who come on. But that information is just not there. So I think there's got to be a better way to do this. Speaker 400:33:47If you're going to give us information, go through all these bullet points, give us the progress points. Among the things you don't tell us is your outlook statement and the actual text of the release. So let me ask you a few questions on that. Based on what you're saying, it seems to be a very much second half loaded results here. When you say 15% to 20% year over year growth for second half. Speaker 400:34:14Are we talking about actually second half of results last year because the second half of twenty twenty two was $3,100,000 in revenues? What should we surmise about the actual outlook for the second half based on what you're saying? Are you suggesting a run rate of revenues or revenues of about $3,500,000 to 4,000,000 dollars Let's start with that first question. Speaker 100:34:45Hi, Marty. This is Mike. So the 15% to 20% comment related to full year 2023 versus full year 2022. So that would imply a growth rate north of 15% to 20% for the second half, if you're looking at second half in isolation, because we're adding together the growth in the first half and the growth in the second half and the growth in the second half is going to be higher. So adding the 2 together, the growth year over year is right now based on what we've our view of the outlook is 15% to 20%, excluding any impact from Medicare, which again we can't comment on until such time that we have more clarity on what the status of the Medicare reimbursement is going to be. Speaker 400:35:34Okay. So that actually suggests $5,500,000 revenues in 2022. You'll exceed that number pretty solidly. Yet, you didn't think it was valuable enough to put it in a commentary because when one sees the revenue number, it's back to just the kind of rate the kind of numbers we're seeing all over the place. Obviously, Q4 was very strong, Q3 was very weak. Speaker 400:36:05And when you go back and forth, it seems to me where is the transparency that could have come through in your actual detailed summary. Curious also, do you see gross margin breaking through the 50% area over the kind of revenue run rate you expect in the second half? Speaker 100:36:31So we need at this stage, we need higher volumes to achieve that level of gross margin. We need higher revenue volumes to leverage our fixed costs to be able to reach that level. Speaker 400:36:49So based on this quarter of 47% gross margin, I believe there was. If you're looking at the second half, you would think that gross margin would be considerably higher for Leer's second half revenues. Is that correct? Speaker 100:37:06I'm not going to guide to margins for the year or for the second half. Right now, I'm more comfortable talking about top line. We certainly believe that with higher volumes, we will achieve higher margins. Part of the challenge with our margins right now is that it's off a very small revenue base. So as we build that quarterly revenue volume, the margins will increase as a result of that. Speaker 100:37:33But until we get there, I'd rather not comment specifically on discrete levels. Speaker 400:37:40With regard to the notion that you can get it to breakeven or profitability, I'm wondering if you believe that's the case without an acquisition, meaningful acquisition that you're involved with. And I would like for you to make a comment about how important acquisitions are to this entire story. The adjacencies that you would expect from product extensions obviously can help. But when we're talking about a transformational look at the company via what an acquisition can provide for you, the synergies and costs and even revenues. How important is this? Speaker 400:38:26Because I don't see this as a commentary that suggests this is the single most important thing outside of CMS. Where do you see that as a priority? I'm happy to hear this from both you and Larry on this question. Speaker 200:38:43Well, we've stated both in our objective over the past 2 years, the intention to add product lines in order to leverage the cost structure that we have in place and the skill sets frankly that we offer. So it's very important and it's been a stated objective multiple times over the last few years. I think we've tried to update that in every quarter. I think it's important because it makes Speaker 400:39:07it easier to work with our customer base. Speaker 200:39:07It allows us to use a infrastructure that we built with certain types of expertise, whether it be in clinical or reimbursement or other areas. So it is an important business strategy of ours that we are pursuing, but we're pursuing it prudently. Whatever we add has got to be something that meets the criteria that we have set out as a company. We're not looking to add things just for the sake of adding and we're adding something that fits strategically and will enhance the business. And I think the real value of it, it shortens the path to profitability because the CMS path will take some time for a market that will be meaningful. Speaker 200:39:50By adding additional product lines, it will shorten that timeline, we believe, to profitability. Speaker 400:39:56It's clear to me, and I think as all investors are looking at the burn rate quarter to quarter, as that number continues. And clearly, there is the end goal, which is to turn this company around, get the scalability of not only the exoskeleton but also on the other products potentially. The notion that an acquisition is important, I wonder if you can just tell us, are you involved in some serious discussions with a particular acquisition target? I mean, because if you are, it's okay to say we haven't closed anything, we're not there yet, but I think we need to know whether you are actually in serious discussion with any potential targets. I think as investors, we should know that. Speaker 400:40:46Since this becomes a very critical reason why investors will say, okay, transformational acquisition is really still part of the story. Can you tell us where you are on the acquisition front or on the acquisition hunt? Speaker 200:41:03I can tell you that we have looked at many companies and have had discussions where we believe they make sense, but I can't comment beyond that. Speaker 400:41:14Even to say that you might be in a due diligence point with any particular acquisition targets, have you defined that target? At least is there one that you're saying will be the first of those potential targets that you can you're actually in some discussions with? Clearly, I don't expect to know that you're going to close anything at any time, but investors who are listening to this call would want to know how far along are you in these discussions? Speaker 200:41:43We have clearly defined targets that we believe would fit well with our company. But completing a process has a lot of elements to it and I can't comment further than that at this point until we get past all of the stages that it requires to make that public announcement. Speaker 400:42:05Larry, last question. With regard to profitability, do you see that possible, let's say, in the next 12 to 18 months with the current business model that you have in place? I mean, is that possible? And the reason is clearly because the $4,000,000 to $5,000,000 of cash burn per quarter means that we're going to run out of cash in a few years. And even as that is happening, the stock price per share is at some 40%, 50% discount to the actual net cash per share. Speaker 400:42:43That to me is a concern that we're seeing a slippery slope. We don't know where it's going to stop. Clearly, there's some very positive fundamentals around everything you've said today. I think it would have been much better if some of this was in print. But please comment on profitability. Speaker 400:43:06Can you be profitable without an acquisition? Speaker 200:43:11That depends on CMS. I mean, to answer that question to an extent. So there are circumstances where it certainly could be. We have developed models of what it would take to get us to profitability on our current cash. That is a combination of existing products and adding products. Speaker 200:43:32If coverage were more favorable and more easily achieved, it could be more easily done with the BREWALK product line as a standalone. But we think it's most efficiently done by having a few product lines with the same call points, the same physician groups, but adding things that are going to be accretive in a very short cycle. Speaker 400:43:55Okay. Thank you, gentlemen. Speaker 100:43:58Thanks, Marty. Thank you, Marty. Operator00:44:01And our next question will come from Dan Yargrove with NBS Investments. Please go ahead with your question. Speaker 500:44:08Yes, sir. Thank you for taking the call. I'd like some color on the repurchase program where it exists. You said earlier that I think in the Q1 it was $771,000 I was wondering if that's an inclusive number of everything that's been repurchased on the $8,000,000 or that's just a quarterly figure. So could you all give us some color on that? Speaker 500:44:32And secondly, I know that there can't be an act of strategy. It's based on what we do, but what's the progress or is there any strategy or is there any forward looking on trying to increase the stock price? Speaker 200:44:56You want to start with the buyback and I'll Yes, sure. Yes. Speaker 100:44:59Hi, Daniel. So this is Mike. So the $770,000 I quoted in the remarks earlier related to activity in Q1. So that was specific only to the Q1 of this year. Speaker 500:45:18It was the total amount then from the inception of the buyback to now. Do you have a number for that? Speaker 400:45:24$3,300,000 So, Speaker 100:45:28if that again, please? It was an there'd be an additional $2,500,000 that we purchased before last quarter. So it will be the combination of the $770,000,000 and the $2,500,000 or $3,300,000 in total. Speaker 500:45:46Okay. And so you all are on projection in the next 6 months cycle to get the rest purchased or is it going to take another execution of another 6 month turn to get it done? Speaker 100:46:01It's highly dependent on the share price and the volume of shares that are traded. So I can't give you that answer because we don't know until we get there. Speaker 200:46:15And I think the other half of the question is part of the answer where you asked about the price per share. And we believe that there are several things that should impact our stock price. Milestones are the biggest. The process of CMS changes this industry and it changes this company once we cross that milestone. The addition of other product lines also would change some of the profile of our company. Speaker 200:46:46So the milestone components we believe are reasonably close in, but with the government you can't define reasonably entirely for timing, but they're working with us. In parallel, you've seen a change in investment and time and money and talent for Investor Relations. And we believe that will help us bring in higher volumes and more investors built around the milestones in the long term path that we have. We are very aggressively in both of those areas using them as a vehicle to improve the price per share if we can achieve these milestones and communicate it well. Speaker 500:47:31I appreciate that because as a long term investor, I believe strongly in the product and I'm pretty much all in on it. We are and I just I'm interested in that idea of a better flow of information. It's hard to come by. So any efforts you could put into Investor Relations and a better free flow of information would be highly appreciated. And I'll leave it with that. Speaker 500:48:03Thank you very much. Speaker 200:48:05Thank you. And with the addition of LifeSci Advisors, I think they will help us a great deal as they do this with many companies. And I'd also Mike and I do our best to respond to every investor when they have questions. We obviously stay with only public information, but we're glad to take calls or emails or text at any time. Speaker 400:48:29Thank you. Operator00:48:32And this concludes our question and answer session. I would like to turn the conference back over to Larry for any closing remarks. Speaker 200:48:40Okay. I would like to thank everybody for the participation. And I think the question asked at the beginning around CMS expansion and our confidence in where this is going, very clearly this product works, our data is there and we see the market reacting to it slowly, but reacting to it. CMS has taken this far. When or if and how they finish it is still to be determined. Speaker 200:49:10But we have come a very long way over these past 6 to 12 months in CMS. And that's why you see us putting in 10 claims in Q2 and 35 to 50 for the year. Those are game changers. And I think that's the most important thing to watch as to when and how they develop. So with that, thank you. Speaker 200:49:31And for anybody who is looking for information, please reach to LifeSci Advisors, Mike or myself, and we will communicate everything that we can. Thank you. Operator00:49:43The conference has now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallReWalk Robotics Q1 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) ReWalk Robotics Earnings HeadlinesFirst Major U.S. Commercial Health Insurer Approves Purchase of ReWalk 7 Personal ExoskeletonApril 29, 2025 | globenewswire.comLifeward says Israeli soldier walks again with ReWalk Personal ExoskeletonApril 24, 2025 | markets.businessinsider.comTrump wipes out trillions overnight…Is there anybody more powerful than Donald Trump right now? In a single tariff announcement, he wiped out nearly $5 trillion in wealth from the S&P 500 and $6.4 trillion from the Dow Jones… Not to mention the countless trillions of dollars lost in every market around the world… leaving the major political powers scrambling in fear of Trump’s next move.May 4, 2025 | Porter & Company (Ad)Paralyzed Israeli Soldier Walks Again with Use of the ReWalk Personal ExoskeletonApril 24, 2025 | globenewswire.comLifeward launches sales of ReWalk 7 Personal Exoskeleton in the U.S.April 15, 2025 | markets.businessinsider.comLifeward Launches Sales of the ReWalk 7 Personal Exoskeleton in U.S. MarketApril 15, 2025 | globenewswire.comSee More ReWalk Robotics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like ReWalk Robotics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on ReWalk Robotics and other key companies, straight to your email. Email Address About ReWalk RoboticsReWalk Robotics (NASDAQ:LFWD), a medical device company, designs, develops, and commercializes technologies that enable mobility and wellness in rehabilitation and daily life for individuals with physical and neurological conditions in the United States, Europe, the Asia-Pacific, and internationally. It offers ReWalk personal exoskeleton and rehabilitation exoskeleton devices; ReStore, a soft exo-suit intended for use in the rehabilitation of individuals with lower limb disability due to stroke; AlterG Anti-Gravity System for use in physical and neurological rehabilitation and athletic training; MyoCycle devices; and ReBoot, a personal soft exo-suit for home and community use by individuals post-stroke. The company markets and sells its products directly to institutions and individuals, as well as through third-party distributors. The company was formerly known as Argo Medical Technologies Ltd. ReWalk Robotics Ltd. was incorporated in 2001 and is headquartered in Yokneam Illit, Israel.View ReWalk Robotics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Amazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernVisa Q2 Earnings Top Forecasts, Adds $30B Buyback PlanMicrosoft Crushes Earnings, What’s Next for MSFT Stock?Qualcomm's Earnings: 2 Reasons to Buy, 1 to Stay AwayAMD Stock Signals Strong Buy Ahead of Earnings Upcoming Earnings Palantir Technologies (5/5/2025)Vertex Pharmaceuticals (5/5/2025)Realty Income (5/5/2025)Williams Companies (5/5/2025)CRH (5/5/2025)Advanced Micro Devices (5/6/2025)American Electric Power (5/6/2025)Constellation Energy (5/6/2025)Marriott International (5/6/2025)Energy Transfer (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 6 speakers on the call. Operator00:00:00Good morning, and welcome to the ReWalk Robotics First Quarter 2023 Earnings Conference Call. All participants will be in a listen only mode for the duration of the call. Please note that this event is being recorded today. I would now like to turn the conference over to Chief Financial Officer, Mike Lawlis. Please go ahead, sir. Speaker 100:00:42Thanks, Joe. Good morning, and welcome to ReWalk Robotics' Q1 2020 earnings call. I'm Mike Lawless, ReWalk Robotics' Chief Financial Officer and with me on today's call is Larry Jasinski, ReWalk's Chief Executive Officer. Earlier this morning, ReWalk issued a press release detailing financial results for the 3 months ended March 31, 2023. The press release and a webcast of this call can be accessed through the Investor Relations section of the ReWalk website atrewalk.com. Speaker 100:01:12Before we get started, I'd like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance may be considered forward looking statements within the meaning of the Private Securities Litigation Reform Act. These forward looking statements are based on information available to ReWalk Management as of today and involve risks and uncertainties, including those noted in our press release and ReWalk's filings with the SEC. Such forward looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward looking statements. ReWalk specifically disclaims any intent or obligation to update these forward looking statements whether as a result of new information, future developments or otherwise, except as required by law. Speaker 100:02:03A replay will be available shortly after completion of the call accessible from the dial in information in today's press release. The archived webcast will be available in the Investor Relations section of the company's website. For the benefit of those who may be listening to the replay or the archived webcast, this call was held and recorded on May 11, 2023. Since that date, ReWalk may have made subsequent announcements related to topics discussed. So please reference the company's most recent financial most recent press releases and SEC filings for the most up to date information. Speaker 100:02:37With that, I'll turn the Speaker 200:02:38call over to Reebok's CEO, Larry Jasinski. Thanks, Mike. Welcome, everyone. We appreciate your time with us today. We achieved positive results in Q1 and specifically had continued progress on each of our major areas of focus to drive the business over the next 3 years. Speaker 200:02:57We are on track in all respects. The goals remain to move forward with the Centers for Medicare and Medicaid Services, CMS to rebuild our active case submission base post COVID with the acceptance of the state court ruling for direct supply in Germany to advance the design of the ReWalk personal exoskeleton to further improve the user experience and to identify additional product offerings to build our critical and strategic mass. Sales in Q1 were $1,230,000 in line with internal expectations and in line to support year over year growth driven over the second half of twenty twenty three. The United States has expanded cases with the VA and Germany had a significant increase in submissions in Q1, which will translate to improved second half twenty twenty three sales. Expenses were also in line with internal expectations. Speaker 200:04:00Mike will address this further in the financial results section. Our ongoing efforts with CMS to expand coverage of exoskeletons for Medicare beneficiaries is a key element of our strategic path and a defining point for the exoskeleton industry. We have gained widespread acceptance from SCI societies and key companies in this market. Creating a repeatable process to secure payment for the ReWalk device for Medicare beneficiaries is an essential priority for us. The Medicare SCI population is the largest population segment of individuals who could benefit from this technology and therefore our single largest potential market segment in our single largest potential market, the United States. Speaker 200:04:49The ReWalk personal exoskeleton is innovative. It has been designed as a breakthrough device by the FDA and was cleared through the de novo pathway. Being on the leading edge is both an opportunity and a challenge. The opportunity is that the value is recognized. There are lots of individuals in the federal agencies at the highest levels that are working to help ensure the device is available to patients. Speaker 200:05:15The challenge is that CMS and its local Medicare Administrative Contractors, MACs, haven't directly processed anything quite like this previously. So the process by which these claims are handled must be created to ensure that payment is consistent and timely. The reality is that implementing these new procedures can take time despite the support and guidance that we have continued to receive from leadership within CMS and the MAX. And the only way to refine this is to submit claims in order to test the process, to clarify what needs to be clarified and to fix what needs to be fixed. The good news is that we have made significant progress to this point. Speaker 200:05:58For this strategy, we submitted our 1st Medicare claim and in Q1, early Q2 has seen advancement and meaningful feedback on this claim. As we anticipated, the lack of an established process for submitting claims to the coverage of personal exoskeletons has presented issues that need to be addressed in order for the claim to be paid. We received questions on benefit category, documentation and pricing methodology. We even had some simple administrative challenges from Medicare's claims portal operations. Again, this was to be expected given that this is the first time an exoskeleton claim is moving through the Medicare process. Speaker 200:06:36Fortunately, both CMS and the MAC involved in this claim have engaged with us to move Claimant forward for this beneficiary. Importantly, no significant or insurmountable issues have been identified. Our strategy to submit one claim to start was purposeful. Based upon this experience, we are now ready to submit our next round of claims for additional patient beneficiaries. We aim to submit claims for approximately 10 additional SCI Medicare beneficiaries in Q2 and have received significant positive interest from many more SCI patients and their providers who will be in the queue to follow shortly. Speaker 200:07:17Overall, navigating a new category and process for payment is more tedious than any of us would like, but this is progressing in a meaningful manner. We have put a great team together to support this effort and we will be relentless because this truly is in the best interest of both patients and our healthcare system. I am confident that with the support we have received from both CMS leadership and the MAX involved, we will continue to make material progress one step at a time. At the same time, we are preparing for the future. We have built our organization to enable scaling of our efforts to manage a growing number of claims. Speaker 200:07:56This includes putting an experienced program manager in place, defining and implementing quality standards and operating procedures to operate as a CMS supplier and adding a medical director with a background in physical medicine and rehabilitation and in CMS claims oversight to help with our upcoming claims preparation. We have made progress on all of these initiatives. We will expand the structure further to support increased claims in 2024 2025. I am confident that the results of our efforts will positively shape the industry in the long term. To reiterate again, this is important because over half of all SCI patients are covered by Medicare and Medicaid within 5 years of injury. Speaker 200:08:42So the results of these initiatives will ultimately define beneficiary access to the only technology solution that makes it possible for them to stand, walk, ascend and descend stairs and perform activities of daily living in their home and community. We also have technical progress in parallel with the CMS MAC processes. On March 7, we announced the achievement of FDA clearance for our STAIRS enabled ReWalk personal exoskeleton. This FDA clearance broadens the ability for utilization of the system by removing limits that are a physical reality in areas where people want to walk. Examples are, visiting the home of friends or family where they have steps at the entry and no ramp, areas where there are no curb cutouts on city sidewalks, or using the front door of a business that has an accessible access around back. Speaker 200:09:35Expanding access to everyday walking in everyday environments is a major leap for those who are blocked from too many activities or locations. The design includes the software and controls to ascend or descend steps and curves and enhanced structural components of the ankle and thigh to further improve the robustness of the design. Our extreme example is Simon Kinleysides in England, who achieved a Guinness World Record last year after climbing 1444 steps in a 51 story building in one day, which shows the durability of the system. I congratulate him. Our real focus is everyday life and this FDA clearance offers increased opportunities to experience the benefits of walking in everyday environments even when those environments contain obstacles such as stairs or curbs. Speaker 200:10:29We remain active on a significant number of paths to increase our critical mass and develop long term strategic mass. We are actively seeking opportunities to grow our portfolio of solutions in neurorehabilitation both by way of acquisition and distribution partnerships. This growth will help to expand our relationships with customers and will enable new opportunities to scale our business in the broader neuro rehabilitation market. I'd now like to turn the call over to Mike for a review of the financial details. Mike? Speaker 100:10:59Thanks, Larry. As discussed during our last earnings call, the Q4 2022 performance reflected our success in converting near term opportunities in our pipeline to revenue. As a result, our focus during Q1 2023 was to continue to deliver revenue while adding to our commercial pipeline and lay the foundation for growth in 2023. For the Q1 of 2023, we accomplished both of these objectives with solid revenue and an improved pipeline. ReWalk reported revenue of $1,200,000 up $400,000 or 40% in the Q1 of 2023 as compared to $900,000 in the Q1 of 2022. Speaker 100:11:36This was in line with our internal budget and we remain on track to our internal growth targets for the fiscal year. The increase in revenue compared to Q1 'twenty two was a result of improved ReWalk sales performance in the U. S, partially offset by less traction in the EU. We also grew revenue from our distributed product line, the MyoCycle FES training cycles. In Q1 2023, revenue was over $200,000 up 14% versus revenue in Q1 2022. Speaker 100:12:07The sequential decline versus Q4 2022, we believe to be a result of the timing of trade shows and seasonal buying patterns of our customers. We expect to build sales volumes of Miocycles sequentially as we move through the rest of the year. Turning to our pipeline metrics within the current markets for the ReWalk product line, which includes individuals covered by the Veterans Administration or workers' compensation insurance in the U. S. And by private insurance in Germany, the current pipeline of active rentals consists of 18 cases, including 14 in Germany, 12 insurance and 2 South Pay and 4 VA rentals. Speaker 100:12:43Our overall number of cases in process is 71 with 53 in Germany and 14 in the U. S. As a reminder, these pipeline figures do not include cases that would be eligible for Medicare reimbursement since although we have established Medicare coverage, CMS CMS is still in the process of establishing a benefit category designation under which we can be reimbursed. If our progress with CMS successfully results in the establishment of an acceptable reimbursement mechanism and payment rate, we expect to add our list of already identified Medicare eligible patients for inclusion in our future pipeline figures. Moving to gross margin, in Q1 'twenty three, our gross profit was $571,000 or 46.4 percent of revenue, up 16 percentage points as compared to $265,000 or 30.3 percent of revenue in Q1 'twenty two. Speaker 100:13:35This increase in gross margin was primarily driven by several factors. The impact of higher revenue volumes leveraging our fixed production costs, higher average sales prices on the ReWalk devices and reduced freight and overhead expenses. Operating expenses in Q1 'twenty three were $4,900,000 up $400,000 or 9 percent as compared to $4,500,000 in Q1 'twenty two. Within the functions, R and D spending decreased by $200,000 or 17%, primarily due to lower spending and professional services due to the completion of the STAIRS project and the accomplishment of significant milestones on the ReWalk 7 project. Selling and marketing expenses increased $300,000 or 14%, primarily due to higher consulting fees associated with CMS reimbursement related activity and travel expenses. Speaker 100:14:28General and administrative expenses increased $200,000 or 17% due to higher employee related expenses and professional service fees, partially offset by lower insurance costs. Our net loss for the Q1 of 2023 was $4,300,000 or $0.07 per share as compared to a net loss of $4,400,000 or $0.07 per share in the Q1 of 2022. We ended the quarter with $61,900,000 of cash and equivalents and no debt. Our operating cash usage in Q1 was $4,900,000 which was a decrease from $5,500,000 in Q1 of 2022. However, this is an increase sequentially from Q4 'twenty two because the Q1 of each fiscal year is seasonally the highest quarter for cash consumption. Speaker 100:15:15The timing of annual payments for items such as insurance renewals as well as the payment of annual variable compensation typically occur in Q1. We expect quarterly operating cash usage to decline in Q2 and remain lower than Q1 level for the rest of 2023. We believe our cash balance provides us ample resources to fund the growth of our existing business, including our efforts to expand reimbursement coverage of the ReWalk device as well as to pursue attractive business development opportunities to acquire additional complementary products. We believe both of these investment areas are crucial for us to build scale and accelerate our path to profitability. During Q1 'twenty three, we repurchased approximately $771,000 of ReWalk ordinary shares. Speaker 100:16:05As you may recall, our initial 6 month authorization from the Israeli court for the repurchase program expired in January of this year. So we filed a motion with the court for permission to continue with repurchases for a second 6 month period, which the court approved. We created a new 10b5-1 plan for the 2nd 6 month period, which automatically repurchases shares when the criteria of the plan are met. Now I would like to briefly comment on our financial outlook for Q2, 2023 and the full year 2023. Based on the current pipeline for ReWalk Systems, we expect Q2 revenue to be similar to the level in Q1 of Q1 revenue with growth accelerating in the second half of the year. Speaker 100:16:45For the full year 2023, we anticipate revenue growth of approximately 15% to 20% versus the results in full year 2022. Importantly, these outlooks for Q2 and FY2023 do not include revenue from sales to Medicare eligible patients. While we will be shipping more ReWalk devices to users and submitting claims to Medicare during Q2, as Larry described, these transactions will not contribute to revenue until the MACs begin to process and pay claims. Until that process gets underway and we have visibility to the processing timetable and payment rates, we will continue to exclude the impact of potential Medicare payments from our financial outlook. With that, I'll turn the call back to Larry for further remarks. Speaker 100:17:30Thank you, Mike. Speaker 200:17:33We laid out our goals for 2023 at the start of the year and I on each of them after each quarter. To restate the goals, to achieve sales growth via our workman's compensation and VA activity in the United States along with more contracted insurers in Germany. Number 2, to expand our portfolio of products through distribution agreements or product line acquisitions and number 3, to leverage these activities to move towards breakeven profitable operations with our current capital. To measure our progress in Q1, I have 7 areas I would like to highlight. 1st, expansion of CMS case submissions. Speaker 200:18:16Our processes and infrastructure for qualifying and processing claims is operational to meet our goals in 2023. We added experienced talent in terms of preparing the pipeline for submissions, expanded clinical experience with recruiting a medical director with significant experience managing CMS claims, who is also a physical medicine and rehabilitation physician, typically noted as a PM and R physician or physiatrist with clinical experience treating spinal cord injury patients. Our interaction with the CMS and the MAX in Q1 has provided us a better opportunity to understand the structure and approach they recommend giving the newness of exoskeletons. We will submit 10 or more claims in Q2 with a target of submitting 35 to 50 Medicare claims for 2023. The information gained with claim 1 are key steps that support achieving our goal. Speaker 200:19:13We have now tested the system, identified the requirements and streamlined the claims process. Given these critical steps, we expect to have a repeatable system that will expand in 2024. Progress with establishing coverage for Medicare benefits is especially meaningful for this population as approximately 30% of U. S. Individuals spinal cord injury are covered under Medicare and another 25% are covered under Medicaid within 5 years after their injury. Speaker 200:19:422nd, expansion of VA training centers. We now have 5 active centers in the U. S. And our goal is to expand that by 5 or more over the remainder of the calendar year. We have new sites recruiting veterans, additional certification training scheduled and active discussions with 6 new centers present. Speaker 200:20:033rd, in Germany, we have now presented updates to DGUV and are scheduling discussions with additional groups for our direct supply contracts now that we have post the acceptance in Q4 of direct supply from the court proceedings. We were able to increase submissions in Q1 to a record level and those cases will impact revenue in Q3 and Q4. 4th, product acquisition. We recognize the operating value and financial efficiency of expanding to multiple adjacent product offerings. We have demonstrated success with our integration of distribution products. Speaker 200:20:43These considerations remain highly active and we report on these initiatives as they reach conclusions. 5th, data expansion. On May 9, at ISPORE, which is the Professional Society For Health Economics and Outcomes Research, had a publication titled Powered exoskeletons for personal use in the home and community may be associated with lower health resource utilization cost in veterans with SCI. This study compared outcomes with 31 exoskeleton users to 54 wheelchair only users. The results demonstrated that powered exoskeletons for personal use, PEP, may be associated with lower utilization cost in veterans with SCI. Speaker 200:21:30Also, a greater proportion of the exoskeleton group had lower health resource utilization cost the year after the prescription than the wheelchair only group. 6th, organic product improvement. The next advancement of the ReWalk system is nearing completion of late stage development and final preparations for FTE and CE submission. We expect to submit this newest design for FTE review and CE review in the second half of twenty twenty three. And 7th, financially, 2023 includes further investment to continue building the required reimbursement in health economic operational infrastructure to support Medicare, VA and private payers. Speaker 200:22:13Our Investor Relations program has increased resources now to communicate the breadth of activity. Our company slide deck has been updated to provide more information is now on our website. With the recent and pending milestones, we are now presenting at new investor conferences and with non deal ROADSHO activities with the help of our Investor Relations firm, LifeSci Advisors. In conclusion, our overall strategic direction continues to be building the core SCI product line as insurance access is more widely accepted. While in parallel, adding adjacent critical and strategic mass as a neuro rehabilitation technology and product consolidator. Speaker 200:22:58We understand and are seeking to complete this level of expansion and growth to achieve a breakeven profitable operation on our current capital. I also wish to thank our shareholders for their continued commitment in supporting these life changing technologies as we expand this business in 2023 2024. I look forward to providing further updates each quarter and through communication of each milestone achieved. I'd now like to answer any questions you may have. So operator, if you could open this up to our audience, we would appreciate that. Operator00:23:32We will now begin the question and answer And our first question here will come from Swayampakula Ramakanth with H. C. Wainwright. Please go ahead with your question. Speaker 300:24:08Thank you. This is RK from H. C. Wainwright. Good morning, Larry and Mike. Speaker 300:24:14I appreciate you doing this call. Certainly, this quarter seems to be pretty strong, started off on a good foot. In terms of submissions to the Germany workers' comp and other insurances that you're talking about. What do you think of the timing or is there anything that you can give us to see how soon the conversion could happen? Or do you see them going to be lumpy during the second quarter and the second half? Speaker 200:25:03This is Larry. I'll answer it first. We see that the record submissions and the number that we got in Q1 are likely to convert in Q3, Q4. Whether they occur in Q3 or Q4 is more variable, so there's a little bit of lumpiness to us. And then of course the submissions we get in here in Q2 would be more geared towards Q4. Speaker 200:25:25So the increase in submissions we're beginning to see on the positive side post COVID, we've got new interest. Our leads are back to pre COVID levels. Our limiters primarily have been the rehab centers are not still staffed at levels to where the dates at which we schedule the users are not as soon as we'd like tomorrow and they're giving us like a week after tomorrow. But other than that, they're progressing reasonably well. So the predicted timing for most of these is 6 to 9 months for a submission to translate to revenue. Speaker 300:26:04Perfect. On the CMS expansion, the reimbursement expansion, I mean, so can you give us a little bit more color as to why you're so confident that you learned enough from one case that you think the not only the smoothness of the submission, but also in terms of them processing the claims is going to be better as in either in the second quarter or in the second half? Speaker 200:26:51I'm going to answer that 2 ways. First, our confidence starts with our product. We absolutely and relentlessly will push this because the data is that good. And what I'm seeing at CMS is a recognition and not a challenge of that. This changes lives and CMS seems to want to take care of its beneficiaries. Speaker 200:27:12So a lot of that is in the data and the science is why we're confident. But there's a parallel element. They've chosen to interact with us. We have had a reasonable number of interactions, some of them inefficient. They couldn't answer things the way we wanted, but they work to help get things through. Speaker 200:27:30They've not given us anything that tells us they're going a different path. And we've certainly talked to them a fair amount in this process. And the advice of putting in additional cases is coming from CMS. Speaker 300:27:48And then as you said, since they are coming to you more than you running after them, does that mean the processing time is going to do you have any idea on the processing time just like what you talked about Germany being anywhere from 3 to 6 months or is it just too early to call it? Speaker 200:28:14I'm afraid it's just too early to call it. I described for them it's a brand new process too and they're trying to fit it in within rules and guidelines they have and this product is so innovative and unique it doesn't fit very well in their structure And that's been the biggest headache we've had so far. They've been trying to figure out where to put it and how to process it. And they part of them processing it the way they are now with the MAX is the MAX have a little more flexibility. And I think we'll see more structure built over time through CMS. Speaker 200:28:45But they haven't given us timelines. That's why it's not yet in our financials forecast. But we believe that's a function of us finishing the process. Speaker 300:28:56Okay. Regarding the VA training centers, VA is one organization that has seen this product for the longest of time. With COVID or basically no COVID at this point, so what are you seeing in terms of people getting trained and also them trying to speed up? Is there are there the same similar issues as in the German training centers in terms of people them having enough personnel to train and other such issues? Speaker 200:29:44That varies greatly by site. There are some sites that are well resourced and able to do it. And as we look at the newer centers, some of them are ones that are well resourced, so that's why they jumped in. The others have progressed towards a model of they'll still handle the patient, but they've used the community care networks, the CCNs, as a place to do the training, which has dealt with their staffing challenges. And that seems to be a formula of some of the other VAs like. Speaker 200:30:14The addition was somewhere we were at 3 in the past. We noted that they're now 5. So we've gone up by 2 since we last talked to you and we're looking at another 5. The coverage for these individuals will start to broaden. One of our other limits was we were really limited to a very small geographic area where the few centers were. Speaker 200:30:35As we get to 10, we'll have a greater geographic push and that will allow many of these people that have been waiting a path to get their exoskeleton. So the VA has reopened, but we want more of them opened. So getting these next five matters and if we're ending the year with at least 10 active centers, we're going to get to be able to fill the request of a large percentage of the ones that have been waiting over these past few years. Speaker 300:31:04Thank you. One last question from me is, so getting to use the exoskeleton to climb stairs, as you said, is certainly a huge benefit for some or all of the users. So how is that translating into potential patients trying to come in and say, now that you have it, so you have everything that I want, so can I get trained? That sort of the conversation. How much of that is increasing and what do you what are your comments on that end of things? Speaker 200:31:47The specific patients, they look at it as the more they can use this the better, the ones that are more favorable. And when you take away limitations, they are more favorable in the product. But I would generally say most of them are already favorable, and it was a matter of finding a way to get it paid for. So the CMS and VA coverage is going to get the majority of the audience. What this will really do is make it a better product for the beneficiaries of CMS and better product for the VA because the users will use it more. Speaker 200:32:17And that's what they really want. So that is the bigger value. It takes away obstacles, but it's generally so far taken away obstacles from people who already wanted it. Speaker 300:32:28Perfect. Thank you very much for taking all my questions. Operator00:32:41Our next question here will come from Martin Pawlick with KNCR. Please go ahead with your question. Speaker 400:32:49Good morning, gentlemen. Two questions, if you can hear me. I'd like to ask you first with regard to the commentary you provided, which was quite useful and helpful in terms of providing more transparency. That you've reserved for the conference call itself. In the past, you've actually done that, providing more clarity, going through those bullet points. Speaker 400:33:29I don't know what motivated you not to make any comments on that. But remember, not everybody is necessarily on this call. As we know, there's just a few investors who come on. But that information is just not there. So I think there's got to be a better way to do this. Speaker 400:33:47If you're going to give us information, go through all these bullet points, give us the progress points. Among the things you don't tell us is your outlook statement and the actual text of the release. So let me ask you a few questions on that. Based on what you're saying, it seems to be a very much second half loaded results here. When you say 15% to 20% year over year growth for second half. Speaker 400:34:14Are we talking about actually second half of results last year because the second half of twenty twenty two was $3,100,000 in revenues? What should we surmise about the actual outlook for the second half based on what you're saying? Are you suggesting a run rate of revenues or revenues of about $3,500,000 to 4,000,000 dollars Let's start with that first question. Speaker 100:34:45Hi, Marty. This is Mike. So the 15% to 20% comment related to full year 2023 versus full year 2022. So that would imply a growth rate north of 15% to 20% for the second half, if you're looking at second half in isolation, because we're adding together the growth in the first half and the growth in the second half and the growth in the second half is going to be higher. So adding the 2 together, the growth year over year is right now based on what we've our view of the outlook is 15% to 20%, excluding any impact from Medicare, which again we can't comment on until such time that we have more clarity on what the status of the Medicare reimbursement is going to be. Speaker 400:35:34Okay. So that actually suggests $5,500,000 revenues in 2022. You'll exceed that number pretty solidly. Yet, you didn't think it was valuable enough to put it in a commentary because when one sees the revenue number, it's back to just the kind of rate the kind of numbers we're seeing all over the place. Obviously, Q4 was very strong, Q3 was very weak. Speaker 400:36:05And when you go back and forth, it seems to me where is the transparency that could have come through in your actual detailed summary. Curious also, do you see gross margin breaking through the 50% area over the kind of revenue run rate you expect in the second half? Speaker 100:36:31So we need at this stage, we need higher volumes to achieve that level of gross margin. We need higher revenue volumes to leverage our fixed costs to be able to reach that level. Speaker 400:36:49So based on this quarter of 47% gross margin, I believe there was. If you're looking at the second half, you would think that gross margin would be considerably higher for Leer's second half revenues. Is that correct? Speaker 100:37:06I'm not going to guide to margins for the year or for the second half. Right now, I'm more comfortable talking about top line. We certainly believe that with higher volumes, we will achieve higher margins. Part of the challenge with our margins right now is that it's off a very small revenue base. So as we build that quarterly revenue volume, the margins will increase as a result of that. Speaker 100:37:33But until we get there, I'd rather not comment specifically on discrete levels. Speaker 400:37:40With regard to the notion that you can get it to breakeven or profitability, I'm wondering if you believe that's the case without an acquisition, meaningful acquisition that you're involved with. And I would like for you to make a comment about how important acquisitions are to this entire story. The adjacencies that you would expect from product extensions obviously can help. But when we're talking about a transformational look at the company via what an acquisition can provide for you, the synergies and costs and even revenues. How important is this? Speaker 400:38:26Because I don't see this as a commentary that suggests this is the single most important thing outside of CMS. Where do you see that as a priority? I'm happy to hear this from both you and Larry on this question. Speaker 200:38:43Well, we've stated both in our objective over the past 2 years, the intention to add product lines in order to leverage the cost structure that we have in place and the skill sets frankly that we offer. So it's very important and it's been a stated objective multiple times over the last few years. I think we've tried to update that in every quarter. I think it's important because it makes Speaker 400:39:07it easier to work with our customer base. Speaker 200:39:07It allows us to use a infrastructure that we built with certain types of expertise, whether it be in clinical or reimbursement or other areas. So it is an important business strategy of ours that we are pursuing, but we're pursuing it prudently. Whatever we add has got to be something that meets the criteria that we have set out as a company. We're not looking to add things just for the sake of adding and we're adding something that fits strategically and will enhance the business. And I think the real value of it, it shortens the path to profitability because the CMS path will take some time for a market that will be meaningful. Speaker 200:39:50By adding additional product lines, it will shorten that timeline, we believe, to profitability. Speaker 400:39:56It's clear to me, and I think as all investors are looking at the burn rate quarter to quarter, as that number continues. And clearly, there is the end goal, which is to turn this company around, get the scalability of not only the exoskeleton but also on the other products potentially. The notion that an acquisition is important, I wonder if you can just tell us, are you involved in some serious discussions with a particular acquisition target? I mean, because if you are, it's okay to say we haven't closed anything, we're not there yet, but I think we need to know whether you are actually in serious discussion with any potential targets. I think as investors, we should know that. Speaker 400:40:46Since this becomes a very critical reason why investors will say, okay, transformational acquisition is really still part of the story. Can you tell us where you are on the acquisition front or on the acquisition hunt? Speaker 200:41:03I can tell you that we have looked at many companies and have had discussions where we believe they make sense, but I can't comment beyond that. Speaker 400:41:14Even to say that you might be in a due diligence point with any particular acquisition targets, have you defined that target? At least is there one that you're saying will be the first of those potential targets that you can you're actually in some discussions with? Clearly, I don't expect to know that you're going to close anything at any time, but investors who are listening to this call would want to know how far along are you in these discussions? Speaker 200:41:43We have clearly defined targets that we believe would fit well with our company. But completing a process has a lot of elements to it and I can't comment further than that at this point until we get past all of the stages that it requires to make that public announcement. Speaker 400:42:05Larry, last question. With regard to profitability, do you see that possible, let's say, in the next 12 to 18 months with the current business model that you have in place? I mean, is that possible? And the reason is clearly because the $4,000,000 to $5,000,000 of cash burn per quarter means that we're going to run out of cash in a few years. And even as that is happening, the stock price per share is at some 40%, 50% discount to the actual net cash per share. Speaker 400:42:43That to me is a concern that we're seeing a slippery slope. We don't know where it's going to stop. Clearly, there's some very positive fundamentals around everything you've said today. I think it would have been much better if some of this was in print. But please comment on profitability. Speaker 400:43:06Can you be profitable without an acquisition? Speaker 200:43:11That depends on CMS. I mean, to answer that question to an extent. So there are circumstances where it certainly could be. We have developed models of what it would take to get us to profitability on our current cash. That is a combination of existing products and adding products. Speaker 200:43:32If coverage were more favorable and more easily achieved, it could be more easily done with the BREWALK product line as a standalone. But we think it's most efficiently done by having a few product lines with the same call points, the same physician groups, but adding things that are going to be accretive in a very short cycle. Speaker 400:43:55Okay. Thank you, gentlemen. Speaker 100:43:58Thanks, Marty. Thank you, Marty. Operator00:44:01And our next question will come from Dan Yargrove with NBS Investments. Please go ahead with your question. Speaker 500:44:08Yes, sir. Thank you for taking the call. I'd like some color on the repurchase program where it exists. You said earlier that I think in the Q1 it was $771,000 I was wondering if that's an inclusive number of everything that's been repurchased on the $8,000,000 or that's just a quarterly figure. So could you all give us some color on that? Speaker 500:44:32And secondly, I know that there can't be an act of strategy. It's based on what we do, but what's the progress or is there any strategy or is there any forward looking on trying to increase the stock price? Speaker 200:44:56You want to start with the buyback and I'll Yes, sure. Yes. Speaker 100:44:59Hi, Daniel. So this is Mike. So the $770,000 I quoted in the remarks earlier related to activity in Q1. So that was specific only to the Q1 of this year. Speaker 500:45:18It was the total amount then from the inception of the buyback to now. Do you have a number for that? Speaker 400:45:24$3,300,000 So, Speaker 100:45:28if that again, please? It was an there'd be an additional $2,500,000 that we purchased before last quarter. So it will be the combination of the $770,000,000 and the $2,500,000 or $3,300,000 in total. Speaker 500:45:46Okay. And so you all are on projection in the next 6 months cycle to get the rest purchased or is it going to take another execution of another 6 month turn to get it done? Speaker 100:46:01It's highly dependent on the share price and the volume of shares that are traded. So I can't give you that answer because we don't know until we get there. Speaker 200:46:15And I think the other half of the question is part of the answer where you asked about the price per share. And we believe that there are several things that should impact our stock price. Milestones are the biggest. The process of CMS changes this industry and it changes this company once we cross that milestone. The addition of other product lines also would change some of the profile of our company. Speaker 200:46:46So the milestone components we believe are reasonably close in, but with the government you can't define reasonably entirely for timing, but they're working with us. In parallel, you've seen a change in investment and time and money and talent for Investor Relations. And we believe that will help us bring in higher volumes and more investors built around the milestones in the long term path that we have. We are very aggressively in both of those areas using them as a vehicle to improve the price per share if we can achieve these milestones and communicate it well. Speaker 500:47:31I appreciate that because as a long term investor, I believe strongly in the product and I'm pretty much all in on it. We are and I just I'm interested in that idea of a better flow of information. It's hard to come by. So any efforts you could put into Investor Relations and a better free flow of information would be highly appreciated. And I'll leave it with that. Speaker 500:48:03Thank you very much. Speaker 200:48:05Thank you. And with the addition of LifeSci Advisors, I think they will help us a great deal as they do this with many companies. And I'd also Mike and I do our best to respond to every investor when they have questions. We obviously stay with only public information, but we're glad to take calls or emails or text at any time. Speaker 400:48:29Thank you. Operator00:48:32And this concludes our question and answer session. I would like to turn the conference back over to Larry for any closing remarks. Speaker 200:48:40Okay. I would like to thank everybody for the participation. And I think the question asked at the beginning around CMS expansion and our confidence in where this is going, very clearly this product works, our data is there and we see the market reacting to it slowly, but reacting to it. CMS has taken this far. When or if and how they finish it is still to be determined. Speaker 200:49:10But we have come a very long way over these past 6 to 12 months in CMS. And that's why you see us putting in 10 claims in Q2 and 35 to 50 for the year. Those are game changers. And I think that's the most important thing to watch as to when and how they develop. So with that, thank you. Speaker 200:49:31And for anybody who is looking for information, please reach to LifeSci Advisors, Mike or myself, and we will communicate everything that we can. Thank you. Operator00:49:43The conference has now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.Read morePowered by