NASDAQ:LFWD ReWalk Robotics Q4 2023 Earnings Report $1.39 -0.02 (-1.42%) Closing price 04:00 PM EasternExtended Trading$1.36 -0.03 (-1.87%) As of 07:13 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-$0.35Consensus EPS -$0.91Beat/MissBeat by +$0.56One Year Ago EPSN/AReWalk Robotics Revenue ResultsActual Revenue$6.88 millionExpected Revenue$7.20 millionBeat/MissMissed by -$320.00 thousandYoY Revenue GrowthN/AReWalk Robotics Announcement DetailsQuarterQ4 2023Date2/27/2024TimeN/AConference Call DateTuesday, February 27, 2024Conference 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)Earnings HistoryCompany ProfilePowered by ReWalk Robotics Q4 2023 Earnings Call TranscriptProvided by QuartrFebruary 27, 2024 ShareLink copied to clipboard.There are 5 speakers on the call. Operator00:00:00Good morning, and welcome to the 4th Quarter and Full Year 2023 Lifeword Earnings Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Mike Lawless, CFO of LifeWard. Please go ahead. Speaker 100:00:43Thank you, Drew. Good morning and welcome to LifeWard's Q4 2023 earnings call. I'm Mike Lawless, LifeWard's Chief Financial Officer and with me on today's call is Larry Jasinski, our Chief Executive Officer. Earlier this morning, LifeWard issued a press release detailing our financial results for the 3 months and full year ended December 31, 2023. The press release and a webcast of this call can be accessed through the Investor Relations section of the LifeWard website at golifeword.com. Speaker 100:01:13Before we get started, I would 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 Life Board's management as of today and involve risks and uncertainties, including those noted in our press release and our filings with the Securities and Exchange Commission. Such forward looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward looking statements. LifeWorks 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 our website. For the benefit of those who may be listening to the replay or an archived webcast, this call was held and recorded on February 27, 2024. Since that date, LifeWard may have made subsequent announcements related to topics discussed. So please reference the company's most recent press releases and SEC filings for the most up to date information. Speaker 100:02:36And with that, I'll turn the call over to Larry. Go ahead. Thank you, Mike. Speaker 200:02:41Good day to all. 2023 was a very successful year, achieving milestones that have set us up for exciting growth and expansion. Our investment and success in gaining Medicare payment for exoskeletons, acquisition of commercially successful and highly innovative anti gravity products, the strategic building of a scalable organization with combined talent of the new entity Lifeword and ongoing technology leadership with new products are the key milestones of 2023. We believe 2024 is our year to capitalize on these achievements as we will move forward with our sales strategy. In addition to revenue growth, we are poised to leverage our existing operations to minimize our cost that puts us on a path to profitability in 2026. Speaker 200:03:35The key highlights for 2023 and the 4th quarter include a 151% increase in annual revenue to $13,900,000 in 2023, a 2 16% increase in Q4 revenue to $6,900,000 from prior year Q4 the rebranding of the company as Lifeword to reflect our vision and mission integration of the commercial and operational resources of the former ReWalk and Altergy businesses to unify the teams and leverage the inherent strengths of both organizations, resulting in $3,000,000 in annual net savings to be realized in 2024. A public presentation at the November 29 HICPIC session where we stated our case for higher price reimbursement due to the advancements in technology since our original application in 2019. Importantly, we achieved a Medicare reimbursement structure for the ReWalk personal exoskeleton in 2023. We also built internal infrastructure to meet requirements to process Medicare claims. Developed and gained FDA clearance for breakthrough products for stair and curb climbing technology and move forward with innovative new designs of anti gravity technology to launch mid-twenty 24 and afterwards. Speaker 200:05:03Now, as we turn to 2024, final pricing for our breakthrough exoskeletons is expected in the coming weeks and will take effect on April 1, 2024. In preparation, we have completed roughly 35 submissions to date and plan to submit another 60 to 75 claims over the course of 2024. As clinician support develops, we intend to expand our supporting infrastructure appropriately. Both the pace and success of our submissions for reimbursement will define the rate of growth for exoskeletons in the last three quarters of 2024 and into 2025. For 2024, with our anti AlterG anti gravity systems, we are preparing for a mid year launch of a new system designed specifically for the needs of smaller private practice clinics, where we see opportunity for growth. Speaker 200:05:57Across late 2023 early 2024, we completed reorganizing as a single operating entity with the name LifeWard. How do we describe Lifeword? We're not just selling products, we're driving a movement. Lifeword exists to break barriers, redefine possibilities and to guide individuals towards horizons they might have deemed unreachable. Lifeword is not just a name, it's a call to action and an invitation to refine what's possible. Speaker 200:06:34Lifeword aspires to become the unrivaled global leader in pioneering life changing solutions. And our mission is to relentlessly drive innovation to change the lives of people with physical limitations or disabilities by improving their daily lives. Our values are best summed up as being driven, optimistic, empathetic, savvy and results focused. We will offer solutions in the form of multiple product offerings that match our mission and to operate as a profitable growing entity. How will we change the organization? Speaker 200:07:15I can say that we have scaled our capabilities to support our growth and penetration goals. In the field, we now have a single sales organization of 18 direct sales individuals covering the U. S, Canada and Germany. We've doubled our supporting field clinical staff, have a U. S. Speaker 200:07:34Network of over 30 field service providers, along with 19 distributors in the EU and 22 distributors for the rest of the world. For internal customer support, we have a dedicated medical director, an internal clinical customer support team to help each inquiring Medicare patient or physician, have an experience and structured reimbursement processing team and resources to maintain government, medical and society affairs focus for industry development. We have quality and operations efforts to meet our targeted sales goals. With the combination of the 2 companies, we have an experienced senior management team in all key areas with a track record of success. Simply stated, we are ready to take on this commercial plan and to achieve our goals. Speaker 200:08:28Where will these technological achievements, government policy successes and new organization take us? First, they remain consistent with our skills and our mission as innovative life changing products combined with exoskeleton coverage access in our 2 largest markets. We anticipate sales growth to achieve annual revenue of $28,000,000 to $32,000,000 depending on the pace and case acceptance level we achieve with Medicare. In parallel, we will reduce our operating loss each quarter in 2024 based on revenue growth, increasing gross margin contribution, gains from cost reduction efforts in 2023 2024 and synergistic leveraging of our expenses with a broader product offering. We forecast reaching profitability on our current cash in 2026. Speaker 200:09:21I'd now like to turn the call over to Mike Lolis for more financial detail. Mike? Thanks, Larry. Speaker 100:09:27Before I review the financial results, I want to remind everyone that our 4th quarter GAAP results include various costs and expenses related to the acquisition of Altergy, which can obscure visibility to the underlying operational performance of LifeWorks. In order to facilitate understanding of both the GAAP results and the operational results of LifeWorks, I want to discuss our performance in the Q4 of 2023 on both a GAAP and non GAAP basis, which excludes the purchase accounting adjustments, transaction expenses, restructuring charges, rebranding and integration costs, inventory charge and stock compensation expense. The reconciliation of the non GAAP to GAAP results is provided in today's earnings release, and I encourage you to reference these tables as I discuss the financials. Moving to revenue. Lifewell reported revenue of $6,900,000 in the Q4 of 2023 compared to $2,200,000 in Q4 of 2022, up $4,700,000 or over 200%. Speaker 100:10:24The increase in revenue is attributable to the acquisition of AlterG. Excluding AlterG sales, the Q4 of 2023 revenue was $2,200,000 up $700,000 sequentially from the Q3 of 2023 and in line with the $2,200,000 reported in the Q4 of 2022. ReWalk exoskeleton revenue in Q4 'twenty three was flat versus Q4 'twenty two on the same number of units sold, while the revenue from the sale of MISOYCLE FES training cycles declined slightly, but was offset with an increase of revenue from restore units. Turning to our pipeline metrics, our pace of active rentals consists of 24 cases, down 2 from last quarter, which is broken down with 21 in Germany and 3 VHA rentals. As of December 31, 2023, our overall number of ReWalk cases in process was 70 with 49 in Germany and 21 in the U. Speaker 100:11:25S. We ended the quarter with orders for 46 UltraG G systems in backlog, which is lower than the backlog at the end of Q3 'twenty three due to our internal focus on our commercial reorganization and integration activities. We expect the Ultra G backlog to return to higher levels in the coming quarters. As Larry discussed earlier, we expect to have submitted a cumulative 35 claims to Medicare by the end of February for reimbursement of ReWalk systems. To date, one of these claims has been paid and we expect that more will begin to be processed and paid by the Medicare contractors in the near future. Speaker 100:12:02This revenue from Medicare will be additive to the revenue from our traditional pipeline of VHA and workers' compensation cases. Moving to gross profit. In the Q4 of 2023, our GAAP gross profit was $2,400,000 or 35.5 percent of revenue as compared to $700,000 or 30.9 percent of revenue in the Q4 of 2022. On a non GAAP basis, gross profit was $3,200,000 or 47 percent of revenue for the Q4 of 'twenty three as compared to $52,800,000 for the Q4 of 'twenty two. The Q4 a year ago had a very favorable mix of product sales and favorable material costs, which contributed to the higher gross margin. Speaker 100:12:45In Q4 'twenty three, AlterG gross margin was accretive to the overall LightBoard consolidated gross margin. Moving to operating expenses. GAAP operating expenses were $8,600,000 in the Q1 in Q4 of 'twenty three, up $2,900,000 or 51 percent compared to $5,700,000 in Q4 'twenty two. Within the major OpEx categories, GAAP R and D expenses were $1,300,000 in Q4 '23 as compared to $1,100,000 in Q4 'twenty two. On a non GAAP basis, R and D expenses were $1,100,000 and flat with the amount in the Q4 of 2022. Speaker 100:13:26Altergy contributed $500,000 in the most recent quarter, while the R and D expenses for ReWalk declined due to lower spending on subcontractors and consultants from the conclusion of the STAIRS Curves project and reduction in spending on the ReWalk 7 project since we are at the final stage before FDA submission. GAAP selling and marketing expenses were $4,800,000 in Q4 'twenty three as compared to $2,700,000 in Q4 'twenty two. On a non GAAP basis, selling and marketing expenses were $4,000,000 up $1,400,000 or 52%. The majority of this increase came from the addition of the Altergy business, which contributed $1,300,000 in selling and marketing expenses. The rest of the increase was primarily due to higher consulting and professional service fees associated with CMS reimbursement related activity. Speaker 100:14:19GAAP general and administrative expenses were $2,400,000 as compared to $1,900,000 in the prior year's quarter. On a non GAAP basis, G and A expenses were $1,900,000 up $300,000 or 17%. The addition of the Alter G business contributed to all of this increase, while G and A from the ReWalk business declined. Our GAAP operating loss for the Q4 was $6,100,000 compared to an operating loss of $5,000,000 in the Q4 of 'twenty 2. The non GAAP operating loss was $3,800,000 in Q4 'twenty three as compared to $4,000,000 in Q4 'twenty two. Speaker 100:14:58The Q4 2023 results also reflect a $1,100,000 sequential improvement in the operating loss versus Q3 'twenty three. As was the case last quarter, the Altergy business had a positive operating profit in Q4 and contributed to the improvement in the non GAAP operating loss. Moving to the balance sheet. We ended the quarter with $28,100,000 in cash and cash equivalents and no debt. Cash used in operations within Q4 was $4,400,000 which includes some transition and integration costs. Speaker 100:15:37Next, I want to provide an update on the status of our listing requirements for NASDAQ. As you know, back in October, we were notified by NASDAQ that our 2nd grace period to regain compliance with the $1 bid price requirement had expired. We requested and received extensions from the NASDAQ hearings panel through March 31, 2024, based on the anticipated announcement of the final payment rates by CMS for exoskeletons, which would we believe would provide the clarity and certainty investors are seeking and positively impact our stock price such that a reverse stock split would not be necessary. At this stage, there are no further extensions available for us under the NASDAQ listing rules. We continue to expect a favorable stock response once the final payment rate is announced by CMS, but the timing of this is uncertain relative to our NASDAQ compliance deadline. Speaker 100:16:31We have our contingency plans in place for our Board to authorize a reverse stock split should the CMS announcement not take place in time for our deadline with NASDAQ. Okay, now moving to financial guidance. As a reminder, Medicare has still not provided a final payment rate for exoskeletons nor do we have the timetable at which the Medicare claims will begin to be processed and paid by the MAX. These two factors have a significant influence on our potential 2024 results. The following guidance is our attempt to factor in the uncertainty related to these two variables with the appropriate conservatism. Speaker 100:17:10For the full year 2024, we expect revenues of between $28,000,000 to $32,000,000 The growth in revenue is driven by a full year's contribution from the AlterG business, augmented by a new product introduction that we expect in mid-twenty 24 of a new entry level model of the Alter G. Additionally, we expect rewalt revenue will benefit from the expansion of the market coming from the new benefit category and payment rate by Medicare starting on April 1. We expect non GAAP gross margin to expand to the high 40% range, driven by volume leverage from a higher level of shipments of ReWalk devices and product cost improvements in the Alter G systems. We expect non GAAP operating expenses to decline from the Q4 2023 run rate level and our non GAAP operating loss will be reduced to the low double digit millions. We expect to exit 2024 with a significantly reduced quarterly operating loss, which provides visibility to achievement of future operating profit. Speaker 100:18:17Since we still have low visibility to the timing and pricing of Medicare payments, our guidance does not anticipate any Medicare revenue in Q1 'twenty four. Additionally, the Q1 is seasonally the lowest quarter of revenue for the AlterG systems and the new combined commercial team, which just came together in January, will also need time to achieve sales traction across the product portfolio. Taking these factors into account, we expect revenue in Q1 'twenty four to be in the range of $5,000,000 to $5,500,000 In the quarters that follow, we expect revenue will increase sequentially on Medicare claims beginning to be paid and the seasonal increase in Alter G revenue supplemented by the new Alter G product introduction expected in mid-twenty 24. With that, I'll turn the call back over to Larry for further remarks. Speaker 200:19:06Thank you, Mike. I would now like to provide more detail on our market goals, our ongoing technological advancements, our commercial operations and our financial goals. 1st, the success of CMS is something we seek to build on in the U. S. Market. Speaker 200:19:23We will work with CMS to optimize the submission process. In parallel, we will initiate interaction with U. S. Private commercial payers and workman compensation groups to seek similar coverage as provided by CMS. These processes are a multiyear approach and we will update accordingly as they progress. Speaker 200:19:45Technology advancement is central to our mission and to our growth expectations. Mid year, we plan to launch a new Ultra G anti gravity model, which has features and pricing specifically designed to address the needs of smaller clinics who have previously been unable to access anti gravity technology as a treatment option for their patients due to limited budgets and other constraints. We see this as an underserved market where this design can advance penetration for these smaller clinics. We have also progressed on technology that expands clinical applications with new features for larger rehab centers. We have not yet established a specific launch date for this product, but seek to launch in 2025. Speaker 200:20:30The ReWalk personal exoskeleton product line will soon be filing an FDA submission for a new iteration of the ReWalk design. It is part of the constant advancement of adding new features and improvements from our extensive interaction with our users. The timing for this launch will be defined by the FDA clearance and we are hopeful this launch will be able to occur in 2024. In addition, separate efforts are being made to establish our longer term pipeline for advancements with exoskeletons and we have incorporated artificial intelligence or AI into a functional prototype to improve usability and add new capabilities. This project is currently focused on testing and development and a timeline for launch we will develop accordingly. Speaker 200:21:19For commercial execution, we are shifting our U. S. Sales team's focus to be more physician orientated as a key element for referrals and market development. This utilizes our larger sales team with deeper clinic driven connections with the broader product offering. Marketing has organized supporting scientific material while working with our medical director to shift this to more to this more scalable approach. Speaker 200:21:47We will educate and assist the medical community to efficiently identify the eligible individuals who would benefit from ReWalk exoskeleton now that Medicare coverage is available. I would now like to address our operational direction for 2024. We expect revenue of $28,000,000 to $32,000,000 and as CMS progresses with our current 35 submissions and the additional $60,000,000 to $75,000,000 that we will do this year. We will be able to better define the pace and impact on the reduction and eventual elimination of our operating loss as the year goes on. We will adjust and work to reduce our operating losses each quarter in 2004 with sales Krausz to obtain synergy from combined operations and increased activity to reduce the cost of goods and improve margins as part of the process as we gain volume. Speaker 200:22:42Our goal is profitability in 2026 on our current cash. We set many milestones in our strategic plan of these past few years, and we have successfully reached them. We are optimistic and confident that LightBoard can now achieve the dream of access to life changing technology with parallel financial success. Thank you everybody for your time today. Operator, can we move to questions, please? Operator00:23:10Yes. We will now begin the question and answer session. The first question comes from Swayampakula Ramakanth with H. C. Wainwright. Operator00:23:55Please go Speaker 300:23:56ahead. Thank you. This is RK from H. C. Wainwright. Speaker 300:24:00Good morning, Larry and Mike. So, a few questions from me. To start off on the CMS reimbursement, is I mean I initially thought that some by the time by the end of this month we should have something in place. Is that still the expectation? And what sort of communications are you having currently with CMS to ensure yourselves that we'll have everything in place for April 1st for it to be effective April 1? Speaker 200:24:46Our expectation is consistent in that we are expecting the rule to take place on April 1, as it always has. We recognize with CMS that there were more than 30 categories of products in the 66 meeting, and we were one of those. So I think they have a lot of detail to answer to get all of the categories done even though most of them have nothing to do with us. We're just a part of a overall package. So our confidence is very high. Speaker 200:25:20April 1 is our effective date. The timing, we also had expected it by now, and we anticipate it any day in order for the MAX to have time to implement the fee schedule into their systems. But I don't have it as of this call. But as soon as I do, you're going to see a press release. Speaker 300:25:37Thanks for that. And then, I think at the end of last year, you got you submitted or you successfully got the submission done to one of the MACs and that actually gave us an indication of how you have set up your systems and they're going smooth. So beyond that, have there been any submissions between then and now? Or are you holding up all your submissions till you get the final ruling? Speaker 200:26:14No, we continued and restarted submissions on January 1 when it switched over to lump sum payment. So we did put them on hold in the latter part of Q4, and we will finish the end of February with a total, this will include the earlier ones of about 35 submissions in, roughly half of them here in the 1st part of this year, the other half were from last year. And again, our timing was simply now we know at least all the later ones are under lump sum payment designation, and we will continue to build our pipeline to try to put in roughly 60 to 75 additional submissions this year. Speaker 300:26:57Okay. Thank you. And then, I want to see what commentary you have in terms of growth expectations in Germany and Europe in general. I did hear on the call you were saying that you have about 18 or 19 sales folks out there and distributors out there. So how are they helping you to grow the business in Europe? Speaker 200:27:29Well, one of the primary advantages of the addition of the AlterD technologies is it built our network in Europe and Asia that we didn't have. So for the AlterG product line, now that they are fully focused on the field and no longer involved with this elements of the Salen acquisition. We expect that they are going to see reasonably good growth in the European and Asian markets through the size and scope of their distribution organization. For our direct team in Germany, we're optimistic on both sides that the AlterG will continue to do well in Germany. It's been a very well accepted product there. Speaker 200:28:17And we see the exoskeleton market beginning to grow in Germany well as we see an increase of up to 50% year over year in Germany. Speaker 300:28:27Perfect. So my last set of questions on AlterG. In general, what is the revenue dynamics as we go through the year? And then for the new product that you're planning to launch in mid-twenty 24, what sort of a market is out there for that product? Thanks. Speaker 200:28:49Mike, I'd ask you to start with the trends. Speaker 100:28:53Yes. So, Arke, we expect that the sales of the Alter G systems will grow sequentially as we move through the year. That's typically been the historical pattern for that business. Whereas the Q1 is the lowest quarter and then it gradually builds as we move through the year. I guess that's a function of the order patterns and the purchasing patterns of the customer base. Speaker 100:29:20But I think that will be particularly true this year because of the fact that the introduction of the new NPI right around mid year is when we're expecting that. So the second half of the year, we'll get the benefit of that new product introduction in addition to the normal seasonal growth that we typically see with that product line. Speaker 200:29:44Okay. And regarding the new product, I'd step back for a second and remind you the ones that we're doing so well with Altergy and entering a new segment is what we're excited about. But the product is extremely well accepted in the professional sports arena, and we expect that business to stay very steady. And we also have a healthy business in the larger rehab clinics. The area we've not been able to penetrate heavily is the smaller private practice places because the features of the products we build into the pro sports, for example, are for £300 people that might run 15 miles an hour. Speaker 200:30:24And in the larger rehab clinics, we have a lot of other features and capability. But these smaller private practice don't need that level of capability. They're not trading pro athletes that they can really work well with an audience. So we have built the features around something that will allow us to begin to penetrate that segment, which is about 15,000 clinics in the U. S. Speaker 200:30:48That is at this point really not penetrated. So it's rounding out us in all of the major markets where this technology could be used. So we're excited about it this year. We'll begin shipping this product right around mid year and it is a significant part of our growth and trajectory for AlterG. Thanks. Speaker 300:31:10Thank you very much for taking all my questions. Good luck this Operator00:31:21The next question comes from Ben Haynor with Alliance Global Partners. Please go ahead. Speaker 100:31:29Good day, gentlemen. Thanks for taking the questions. Can you hear me okay? Yes. Yes, we can. Speaker 400:31:35Great. Just wanted to check on the guidance for how much CMS revenue is included in that? I mean, just kind of back of the envelope, if I look at it and say you've got 35 submissions in that you could get paid for or you've got the 60 to 75 that you plan to put in this year, even at the preliminary figure that could be high single digit millions or even low double digit millions. What's the right way to think about that? And then and I assume any CMS revenue that you do have in there is reimbursed at the preliminary or slated model to be reimbursed at the preliminary reimbursement figure that's out there? Speaker 200:32:24Yes. Hi, Ben. It's Larry. Yes, we have presently modeled this using a combination of our submissions we're making and the preliminary pricing, although we think that will be higher. So we have the 110 claims total. Speaker 200:32:42So the 35 already in place, the 75 new ones, at least that's our goal, 60 to 75, but we expect around 100 or more claims or submissions. The percentage that we are looking for in for payment for 2024, the reason we gave a range is somewhere between 10% and about 40%, we think will be paid in 2024 calendar year, and we believe the balance will be played in the 2025 period. So this is partially building our pipeline for 'twenty five. We're being conservative in our estimates because we can't completely predict the pace of things with CMS and that's how we built that. Speaker 400:33:25So there's upside if that 10% to 40% proportion is higher and obviously if the reimbursement figure is higher, is that the right is that fair? Speaker 200:33:37Yes, we'll take the sale whenever we can get it, so yes. Speaker 400:33:42Okay, fair enough. And then you mentioned kind of refocusing or focusing the sales force more on physician referrals. Can you kind of walk us through a typical patient journey as it stands today to get a personal home unit and then how that might change over the course of this year as Speaker 100:34:05CMS changes take effect? Speaker 200:34:10Well, the definition and activities for CMS will help us a lot. I'll kind of look backwards. Most of our work over the past few years has been very patient driven. We would have a patient and help qualify that patient with our clinical team and then help them through the system. But our referrals really came from patients that really just desperately wanted the benefits of this technology. Speaker 200:34:36The physician community was not really willing to advance this because they didn't want to give false hope to patients. If there was no coverage, they really wouldn't push this with the patient community. So our change in profile to a physician focused approach a little bit here is because it's more scalable and will help us get to the right patients. Our success rate from a patient referred group of individuals is dramatically higher than the individuals who come to us just individually because they get qualified a lot better. For a patient's journey right now, we would encourage and educate them to ask their physician, have their physician guide them through the inclusion exclusion criteria, and then hand them off to our customer service team, which has all the elements that we know we need for a CMS submission, and we help pull that together and get the submission with our internal teams. Speaker 200:35:38And then we work back to the clinic that we originally got the physician or the referral came from and we will do the training there in most cases. And then the product is provided at the end of that cycle. So it's a combination now of the physician as a starting point for many of them, followed by ReWalk's involvement in helping the hard work of processing and preparing a claim that will go through, followed by the clinic training them. And then after that, we have a very good warranty and service program here to make sure these individuals have the device working for the entire 5 year life of the device. So there's the flowchart is much longer than that, but that is a reasonably good verbal explanation. Speaker 400:36:24No, and that makes sense and it's definitely helpful. And our obviously with the patients coming to you is kind of the way that's been historically, obviously you're never going to run Super Bowl ads to try and target all the patients that could potentially be candidates. But in terms of the physicians that you go after, I mean, is that a relatively smaller group of folks that might be X1000 out there that you can easily target or is there sort of a back of the envelope number that we should think about on these your sales force will be going after 2,000 or 10,000 or 500 physicians that really you guys think have the potential to write a lot of prescriptions? Speaker 200:37:23Yes, there's a pretty good variety of the physician base. The core initial one is the PM and R docs, the people who do physical and rehabilitation medicine. As they see these patients particularly early, as patients get a little later in years past their injury, the group becomes more varied with some neurologists and internists. So our initial focus would be a little more in the clinic based. We believe that gives us sufficient numbers for growth. Speaker 200:37:54But over time, getting neurologists and some internal medicine and other groups educated will matter. So I think we have a pretty good early target. It will grow over time for the spinal cord injury side of the business. Speaker 400:38:12Okay. Got it. That's helpful. And then a couple of quick ones. On can you provide the pro form a Alter G revenues for 2023 and the growth versus 2022 or don't you have those available or can provide them? Speaker 100:38:32Pro form a revenue, if you combine the 2 organizations together? Speaker 400:38:36Well, either that way or just AlterGIS kind of a standalone, if you will? Speaker 100:38:43I don't have that in my figure. Speaker 300:38:44Just let me try Speaker 100:38:46to pull that up while we're on the call here. Okay. Speaker 200:38:50Give me a moment. Speaker 400:38:52Yes. No problem. And then just on I guess another one to distract you from the test, but the integration savings that you expect, does that kind of kick in fully during Q1 or does that ramp down into Q2 and beyond or should we just model it as kind of $750,000 savings over the course of the year? Speaker 100:39:20That will phase in over time. That's not all immediate. We should start to see the benefit of that in Q1, but we won't really see the full impact until we move later through the year. Okay. That's helpful. Speaker 100:39:37For the time to kick in. Speaker 400:39:40Makes sense. Okay. Speaker 100:39:42I think that's all Speaker 400:39:43I had. And I'll leave it at that. Speaker 100:39:46And thanks for taking the questions, guys. Thanks, Matt. Thank you, Ben. I'll follow-up with you with the answer to that other question that Speaker 200:39:54you had. Operator00:39:57This concludes our question and answer session. I would like to turn the conference back over to Larry Chiesinski for any closing remarks. Speaker 200:40:07I'd like to thank everyone for joining us today. I started out with a fairly long list of 2023 milestones, and we've very much been a milestone driven company because that was the basis for us to really expand. And this is the year we get to do it, that we are moving to execution phase. We have the right team in place, which is an important part of the integration of the companies, and we have the size and scale to do it. So we very much look forward to presenting this on future quarterly calls, and we ask everyone to please watch us closely. Speaker 200:40:44That's it for today. Thank you, everybody. Operator00:40:46The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallReWalk Robotics Q4 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K) 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.comThink NVDA’s run was epic? You ain’t seen nothin’ yetAsk most investors and they’ll probably tell you Nvidia is the undisputed AI stock of the decade. In 2023, it surged 239%. And in 2024, it soared another 171% on the year… But what if I told you there was a way to target those types of “peak Nvidia” profit opportunities in 24 hours or less?May 5, 2025 | Timothy Sykes (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 Is Reddit Stock a Buy, Sell, or Hold After Earnings Release?Warning or Opportunity After Super Micro Computer's EarningsAmazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousRocket Lab Braces for Q1 Earnings Amid Soaring ExpectationsMeta 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 Plan Upcoming Earnings American Electric Power (5/6/2025)Advanced Micro Devices (5/6/2025)Marriott International (5/6/2025)Constellation Energy (5/6/2025)Arista Networks (5/6/2025)Brookfield Asset Management (5/6/2025)Duke Energy (5/6/2025)Energy Transfer (5/6/2025)Mplx (5/6/2025)Ferrari (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. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 5 speakers on the call. Operator00:00:00Good morning, and welcome to the 4th Quarter and Full Year 2023 Lifeword Earnings Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Mike Lawless, CFO of LifeWard. Please go ahead. Speaker 100:00:43Thank you, Drew. Good morning and welcome to LifeWard's Q4 2023 earnings call. I'm Mike Lawless, LifeWard's Chief Financial Officer and with me on today's call is Larry Jasinski, our Chief Executive Officer. Earlier this morning, LifeWard issued a press release detailing our financial results for the 3 months and full year ended December 31, 2023. The press release and a webcast of this call can be accessed through the Investor Relations section of the LifeWard website at golifeword.com. Speaker 100:01:13Before we get started, I would 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 Life Board's management as of today and involve risks and uncertainties, including those noted in our press release and our filings with the Securities and Exchange Commission. Such forward looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward looking statements. LifeWorks 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 our website. For the benefit of those who may be listening to the replay or an archived webcast, this call was held and recorded on February 27, 2024. Since that date, LifeWard may have made subsequent announcements related to topics discussed. So please reference the company's most recent press releases and SEC filings for the most up to date information. Speaker 100:02:36And with that, I'll turn the call over to Larry. Go ahead. Thank you, Mike. Speaker 200:02:41Good day to all. 2023 was a very successful year, achieving milestones that have set us up for exciting growth and expansion. Our investment and success in gaining Medicare payment for exoskeletons, acquisition of commercially successful and highly innovative anti gravity products, the strategic building of a scalable organization with combined talent of the new entity Lifeword and ongoing technology leadership with new products are the key milestones of 2023. We believe 2024 is our year to capitalize on these achievements as we will move forward with our sales strategy. In addition to revenue growth, we are poised to leverage our existing operations to minimize our cost that puts us on a path to profitability in 2026. Speaker 200:03:35The key highlights for 2023 and the 4th quarter include a 151% increase in annual revenue to $13,900,000 in 2023, a 2 16% increase in Q4 revenue to $6,900,000 from prior year Q4 the rebranding of the company as Lifeword to reflect our vision and mission integration of the commercial and operational resources of the former ReWalk and Altergy businesses to unify the teams and leverage the inherent strengths of both organizations, resulting in $3,000,000 in annual net savings to be realized in 2024. A public presentation at the November 29 HICPIC session where we stated our case for higher price reimbursement due to the advancements in technology since our original application in 2019. Importantly, we achieved a Medicare reimbursement structure for the ReWalk personal exoskeleton in 2023. We also built internal infrastructure to meet requirements to process Medicare claims. Developed and gained FDA clearance for breakthrough products for stair and curb climbing technology and move forward with innovative new designs of anti gravity technology to launch mid-twenty 24 and afterwards. Speaker 200:05:03Now, as we turn to 2024, final pricing for our breakthrough exoskeletons is expected in the coming weeks and will take effect on April 1, 2024. In preparation, we have completed roughly 35 submissions to date and plan to submit another 60 to 75 claims over the course of 2024. As clinician support develops, we intend to expand our supporting infrastructure appropriately. Both the pace and success of our submissions for reimbursement will define the rate of growth for exoskeletons in the last three quarters of 2024 and into 2025. For 2024, with our anti AlterG anti gravity systems, we are preparing for a mid year launch of a new system designed specifically for the needs of smaller private practice clinics, where we see opportunity for growth. Speaker 200:05:57Across late 2023 early 2024, we completed reorganizing as a single operating entity with the name LifeWard. How do we describe Lifeword? We're not just selling products, we're driving a movement. Lifeword exists to break barriers, redefine possibilities and to guide individuals towards horizons they might have deemed unreachable. Lifeword is not just a name, it's a call to action and an invitation to refine what's possible. Speaker 200:06:34Lifeword aspires to become the unrivaled global leader in pioneering life changing solutions. And our mission is to relentlessly drive innovation to change the lives of people with physical limitations or disabilities by improving their daily lives. Our values are best summed up as being driven, optimistic, empathetic, savvy and results focused. We will offer solutions in the form of multiple product offerings that match our mission and to operate as a profitable growing entity. How will we change the organization? Speaker 200:07:15I can say that we have scaled our capabilities to support our growth and penetration goals. In the field, we now have a single sales organization of 18 direct sales individuals covering the U. S, Canada and Germany. We've doubled our supporting field clinical staff, have a U. S. Speaker 200:07:34Network of over 30 field service providers, along with 19 distributors in the EU and 22 distributors for the rest of the world. For internal customer support, we have a dedicated medical director, an internal clinical customer support team to help each inquiring Medicare patient or physician, have an experience and structured reimbursement processing team and resources to maintain government, medical and society affairs focus for industry development. We have quality and operations efforts to meet our targeted sales goals. With the combination of the 2 companies, we have an experienced senior management team in all key areas with a track record of success. Simply stated, we are ready to take on this commercial plan and to achieve our goals. Speaker 200:08:28Where will these technological achievements, government policy successes and new organization take us? First, they remain consistent with our skills and our mission as innovative life changing products combined with exoskeleton coverage access in our 2 largest markets. We anticipate sales growth to achieve annual revenue of $28,000,000 to $32,000,000 depending on the pace and case acceptance level we achieve with Medicare. In parallel, we will reduce our operating loss each quarter in 2024 based on revenue growth, increasing gross margin contribution, gains from cost reduction efforts in 2023 2024 and synergistic leveraging of our expenses with a broader product offering. We forecast reaching profitability on our current cash in 2026. Speaker 200:09:21I'd now like to turn the call over to Mike Lolis for more financial detail. Mike? Thanks, Larry. Speaker 100:09:27Before I review the financial results, I want to remind everyone that our 4th quarter GAAP results include various costs and expenses related to the acquisition of Altergy, which can obscure visibility to the underlying operational performance of LifeWorks. In order to facilitate understanding of both the GAAP results and the operational results of LifeWorks, I want to discuss our performance in the Q4 of 2023 on both a GAAP and non GAAP basis, which excludes the purchase accounting adjustments, transaction expenses, restructuring charges, rebranding and integration costs, inventory charge and stock compensation expense. The reconciliation of the non GAAP to GAAP results is provided in today's earnings release, and I encourage you to reference these tables as I discuss the financials. Moving to revenue. Lifewell reported revenue of $6,900,000 in the Q4 of 2023 compared to $2,200,000 in Q4 of 2022, up $4,700,000 or over 200%. Speaker 100:10:24The increase in revenue is attributable to the acquisition of AlterG. Excluding AlterG sales, the Q4 of 2023 revenue was $2,200,000 up $700,000 sequentially from the Q3 of 2023 and in line with the $2,200,000 reported in the Q4 of 2022. ReWalk exoskeleton revenue in Q4 'twenty three was flat versus Q4 'twenty two on the same number of units sold, while the revenue from the sale of MISOYCLE FES training cycles declined slightly, but was offset with an increase of revenue from restore units. Turning to our pipeline metrics, our pace of active rentals consists of 24 cases, down 2 from last quarter, which is broken down with 21 in Germany and 3 VHA rentals. As of December 31, 2023, our overall number of ReWalk cases in process was 70 with 49 in Germany and 21 in the U. Speaker 100:11:25S. We ended the quarter with orders for 46 UltraG G systems in backlog, which is lower than the backlog at the end of Q3 'twenty three due to our internal focus on our commercial reorganization and integration activities. We expect the Ultra G backlog to return to higher levels in the coming quarters. As Larry discussed earlier, we expect to have submitted a cumulative 35 claims to Medicare by the end of February for reimbursement of ReWalk systems. To date, one of these claims has been paid and we expect that more will begin to be processed and paid by the Medicare contractors in the near future. Speaker 100:12:02This revenue from Medicare will be additive to the revenue from our traditional pipeline of VHA and workers' compensation cases. Moving to gross profit. In the Q4 of 2023, our GAAP gross profit was $2,400,000 or 35.5 percent of revenue as compared to $700,000 or 30.9 percent of revenue in the Q4 of 2022. On a non GAAP basis, gross profit was $3,200,000 or 47 percent of revenue for the Q4 of 'twenty three as compared to $52,800,000 for the Q4 of 'twenty two. The Q4 a year ago had a very favorable mix of product sales and favorable material costs, which contributed to the higher gross margin. Speaker 100:12:45In Q4 'twenty three, AlterG gross margin was accretive to the overall LightBoard consolidated gross margin. Moving to operating expenses. GAAP operating expenses were $8,600,000 in the Q1 in Q4 of 'twenty three, up $2,900,000 or 51 percent compared to $5,700,000 in Q4 'twenty two. Within the major OpEx categories, GAAP R and D expenses were $1,300,000 in Q4 '23 as compared to $1,100,000 in Q4 'twenty two. On a non GAAP basis, R and D expenses were $1,100,000 and flat with the amount in the Q4 of 2022. Speaker 100:13:26Altergy contributed $500,000 in the most recent quarter, while the R and D expenses for ReWalk declined due to lower spending on subcontractors and consultants from the conclusion of the STAIRS Curves project and reduction in spending on the ReWalk 7 project since we are at the final stage before FDA submission. GAAP selling and marketing expenses were $4,800,000 in Q4 'twenty three as compared to $2,700,000 in Q4 'twenty two. On a non GAAP basis, selling and marketing expenses were $4,000,000 up $1,400,000 or 52%. The majority of this increase came from the addition of the Altergy business, which contributed $1,300,000 in selling and marketing expenses. The rest of the increase was primarily due to higher consulting and professional service fees associated with CMS reimbursement related activity. Speaker 100:14:19GAAP general and administrative expenses were $2,400,000 as compared to $1,900,000 in the prior year's quarter. On a non GAAP basis, G and A expenses were $1,900,000 up $300,000 or 17%. The addition of the Alter G business contributed to all of this increase, while G and A from the ReWalk business declined. Our GAAP operating loss for the Q4 was $6,100,000 compared to an operating loss of $5,000,000 in the Q4 of 'twenty 2. The non GAAP operating loss was $3,800,000 in Q4 'twenty three as compared to $4,000,000 in Q4 'twenty two. Speaker 100:14:58The Q4 2023 results also reflect a $1,100,000 sequential improvement in the operating loss versus Q3 'twenty three. As was the case last quarter, the Altergy business had a positive operating profit in Q4 and contributed to the improvement in the non GAAP operating loss. Moving to the balance sheet. We ended the quarter with $28,100,000 in cash and cash equivalents and no debt. Cash used in operations within Q4 was $4,400,000 which includes some transition and integration costs. Speaker 100:15:37Next, I want to provide an update on the status of our listing requirements for NASDAQ. As you know, back in October, we were notified by NASDAQ that our 2nd grace period to regain compliance with the $1 bid price requirement had expired. We requested and received extensions from the NASDAQ hearings panel through March 31, 2024, based on the anticipated announcement of the final payment rates by CMS for exoskeletons, which would we believe would provide the clarity and certainty investors are seeking and positively impact our stock price such that a reverse stock split would not be necessary. At this stage, there are no further extensions available for us under the NASDAQ listing rules. We continue to expect a favorable stock response once the final payment rate is announced by CMS, but the timing of this is uncertain relative to our NASDAQ compliance deadline. Speaker 100:16:31We have our contingency plans in place for our Board to authorize a reverse stock split should the CMS announcement not take place in time for our deadline with NASDAQ. Okay, now moving to financial guidance. As a reminder, Medicare has still not provided a final payment rate for exoskeletons nor do we have the timetable at which the Medicare claims will begin to be processed and paid by the MAX. These two factors have a significant influence on our potential 2024 results. The following guidance is our attempt to factor in the uncertainty related to these two variables with the appropriate conservatism. Speaker 100:17:10For the full year 2024, we expect revenues of between $28,000,000 to $32,000,000 The growth in revenue is driven by a full year's contribution from the AlterG business, augmented by a new product introduction that we expect in mid-twenty 24 of a new entry level model of the Alter G. Additionally, we expect rewalt revenue will benefit from the expansion of the market coming from the new benefit category and payment rate by Medicare starting on April 1. We expect non GAAP gross margin to expand to the high 40% range, driven by volume leverage from a higher level of shipments of ReWalk devices and product cost improvements in the Alter G systems. We expect non GAAP operating expenses to decline from the Q4 2023 run rate level and our non GAAP operating loss will be reduced to the low double digit millions. We expect to exit 2024 with a significantly reduced quarterly operating loss, which provides visibility to achievement of future operating profit. Speaker 100:18:17Since we still have low visibility to the timing and pricing of Medicare payments, our guidance does not anticipate any Medicare revenue in Q1 'twenty four. Additionally, the Q1 is seasonally the lowest quarter of revenue for the AlterG systems and the new combined commercial team, which just came together in January, will also need time to achieve sales traction across the product portfolio. Taking these factors into account, we expect revenue in Q1 'twenty four to be in the range of $5,000,000 to $5,500,000 In the quarters that follow, we expect revenue will increase sequentially on Medicare claims beginning to be paid and the seasonal increase in Alter G revenue supplemented by the new Alter G product introduction expected in mid-twenty 24. With that, I'll turn the call back over to Larry for further remarks. Speaker 200:19:06Thank you, Mike. I would now like to provide more detail on our market goals, our ongoing technological advancements, our commercial operations and our financial goals. 1st, the success of CMS is something we seek to build on in the U. S. Market. Speaker 200:19:23We will work with CMS to optimize the submission process. In parallel, we will initiate interaction with U. S. Private commercial payers and workman compensation groups to seek similar coverage as provided by CMS. These processes are a multiyear approach and we will update accordingly as they progress. Speaker 200:19:45Technology advancement is central to our mission and to our growth expectations. Mid year, we plan to launch a new Ultra G anti gravity model, which has features and pricing specifically designed to address the needs of smaller clinics who have previously been unable to access anti gravity technology as a treatment option for their patients due to limited budgets and other constraints. We see this as an underserved market where this design can advance penetration for these smaller clinics. We have also progressed on technology that expands clinical applications with new features for larger rehab centers. We have not yet established a specific launch date for this product, but seek to launch in 2025. Speaker 200:20:30The ReWalk personal exoskeleton product line will soon be filing an FDA submission for a new iteration of the ReWalk design. It is part of the constant advancement of adding new features and improvements from our extensive interaction with our users. The timing for this launch will be defined by the FDA clearance and we are hopeful this launch will be able to occur in 2024. In addition, separate efforts are being made to establish our longer term pipeline for advancements with exoskeletons and we have incorporated artificial intelligence or AI into a functional prototype to improve usability and add new capabilities. This project is currently focused on testing and development and a timeline for launch we will develop accordingly. Speaker 200:21:19For commercial execution, we are shifting our U. S. Sales team's focus to be more physician orientated as a key element for referrals and market development. This utilizes our larger sales team with deeper clinic driven connections with the broader product offering. Marketing has organized supporting scientific material while working with our medical director to shift this to more to this more scalable approach. Speaker 200:21:47We will educate and assist the medical community to efficiently identify the eligible individuals who would benefit from ReWalk exoskeleton now that Medicare coverage is available. I would now like to address our operational direction for 2024. We expect revenue of $28,000,000 to $32,000,000 and as CMS progresses with our current 35 submissions and the additional $60,000,000 to $75,000,000 that we will do this year. We will be able to better define the pace and impact on the reduction and eventual elimination of our operating loss as the year goes on. We will adjust and work to reduce our operating losses each quarter in 2004 with sales Krausz to obtain synergy from combined operations and increased activity to reduce the cost of goods and improve margins as part of the process as we gain volume. Speaker 200:22:42Our goal is profitability in 2026 on our current cash. We set many milestones in our strategic plan of these past few years, and we have successfully reached them. We are optimistic and confident that LightBoard can now achieve the dream of access to life changing technology with parallel financial success. Thank you everybody for your time today. Operator, can we move to questions, please? Operator00:23:10Yes. We will now begin the question and answer session. The first question comes from Swayampakula Ramakanth with H. C. Wainwright. Operator00:23:55Please go Speaker 300:23:56ahead. Thank you. This is RK from H. C. Wainwright. Speaker 300:24:00Good morning, Larry and Mike. So, a few questions from me. To start off on the CMS reimbursement, is I mean I initially thought that some by the time by the end of this month we should have something in place. Is that still the expectation? And what sort of communications are you having currently with CMS to ensure yourselves that we'll have everything in place for April 1st for it to be effective April 1? Speaker 200:24:46Our expectation is consistent in that we are expecting the rule to take place on April 1, as it always has. We recognize with CMS that there were more than 30 categories of products in the 66 meeting, and we were one of those. So I think they have a lot of detail to answer to get all of the categories done even though most of them have nothing to do with us. We're just a part of a overall package. So our confidence is very high. Speaker 200:25:20April 1 is our effective date. The timing, we also had expected it by now, and we anticipate it any day in order for the MAX to have time to implement the fee schedule into their systems. But I don't have it as of this call. But as soon as I do, you're going to see a press release. Speaker 300:25:37Thanks for that. And then, I think at the end of last year, you got you submitted or you successfully got the submission done to one of the MACs and that actually gave us an indication of how you have set up your systems and they're going smooth. So beyond that, have there been any submissions between then and now? Or are you holding up all your submissions till you get the final ruling? Speaker 200:26:14No, we continued and restarted submissions on January 1 when it switched over to lump sum payment. So we did put them on hold in the latter part of Q4, and we will finish the end of February with a total, this will include the earlier ones of about 35 submissions in, roughly half of them here in the 1st part of this year, the other half were from last year. And again, our timing was simply now we know at least all the later ones are under lump sum payment designation, and we will continue to build our pipeline to try to put in roughly 60 to 75 additional submissions this year. Speaker 300:26:57Okay. Thank you. And then, I want to see what commentary you have in terms of growth expectations in Germany and Europe in general. I did hear on the call you were saying that you have about 18 or 19 sales folks out there and distributors out there. So how are they helping you to grow the business in Europe? Speaker 200:27:29Well, one of the primary advantages of the addition of the AlterD technologies is it built our network in Europe and Asia that we didn't have. So for the AlterG product line, now that they are fully focused on the field and no longer involved with this elements of the Salen acquisition. We expect that they are going to see reasonably good growth in the European and Asian markets through the size and scope of their distribution organization. For our direct team in Germany, we're optimistic on both sides that the AlterG will continue to do well in Germany. It's been a very well accepted product there. Speaker 200:28:17And we see the exoskeleton market beginning to grow in Germany well as we see an increase of up to 50% year over year in Germany. Speaker 300:28:27Perfect. So my last set of questions on AlterG. In general, what is the revenue dynamics as we go through the year? And then for the new product that you're planning to launch in mid-twenty 24, what sort of a market is out there for that product? Thanks. Speaker 200:28:49Mike, I'd ask you to start with the trends. Speaker 100:28:53Yes. So, Arke, we expect that the sales of the Alter G systems will grow sequentially as we move through the year. That's typically been the historical pattern for that business. Whereas the Q1 is the lowest quarter and then it gradually builds as we move through the year. I guess that's a function of the order patterns and the purchasing patterns of the customer base. Speaker 100:29:20But I think that will be particularly true this year because of the fact that the introduction of the new NPI right around mid year is when we're expecting that. So the second half of the year, we'll get the benefit of that new product introduction in addition to the normal seasonal growth that we typically see with that product line. Speaker 200:29:44Okay. And regarding the new product, I'd step back for a second and remind you the ones that we're doing so well with Altergy and entering a new segment is what we're excited about. But the product is extremely well accepted in the professional sports arena, and we expect that business to stay very steady. And we also have a healthy business in the larger rehab clinics. The area we've not been able to penetrate heavily is the smaller private practice places because the features of the products we build into the pro sports, for example, are for £300 people that might run 15 miles an hour. Speaker 200:30:24And in the larger rehab clinics, we have a lot of other features and capability. But these smaller private practice don't need that level of capability. They're not trading pro athletes that they can really work well with an audience. So we have built the features around something that will allow us to begin to penetrate that segment, which is about 15,000 clinics in the U. S. Speaker 200:30:48That is at this point really not penetrated. So it's rounding out us in all of the major markets where this technology could be used. So we're excited about it this year. We'll begin shipping this product right around mid year and it is a significant part of our growth and trajectory for AlterG. Thanks. Speaker 300:31:10Thank you very much for taking all my questions. Good luck this Operator00:31:21The next question comes from Ben Haynor with Alliance Global Partners. Please go ahead. Speaker 100:31:29Good day, gentlemen. Thanks for taking the questions. Can you hear me okay? Yes. Yes, we can. Speaker 400:31:35Great. Just wanted to check on the guidance for how much CMS revenue is included in that? I mean, just kind of back of the envelope, if I look at it and say you've got 35 submissions in that you could get paid for or you've got the 60 to 75 that you plan to put in this year, even at the preliminary figure that could be high single digit millions or even low double digit millions. What's the right way to think about that? And then and I assume any CMS revenue that you do have in there is reimbursed at the preliminary or slated model to be reimbursed at the preliminary reimbursement figure that's out there? Speaker 200:32:24Yes. Hi, Ben. It's Larry. Yes, we have presently modeled this using a combination of our submissions we're making and the preliminary pricing, although we think that will be higher. So we have the 110 claims total. Speaker 200:32:42So the 35 already in place, the 75 new ones, at least that's our goal, 60 to 75, but we expect around 100 or more claims or submissions. The percentage that we are looking for in for payment for 2024, the reason we gave a range is somewhere between 10% and about 40%, we think will be paid in 2024 calendar year, and we believe the balance will be played in the 2025 period. So this is partially building our pipeline for 'twenty five. We're being conservative in our estimates because we can't completely predict the pace of things with CMS and that's how we built that. Speaker 400:33:25So there's upside if that 10% to 40% proportion is higher and obviously if the reimbursement figure is higher, is that the right is that fair? Speaker 200:33:37Yes, we'll take the sale whenever we can get it, so yes. Speaker 400:33:42Okay, fair enough. And then you mentioned kind of refocusing or focusing the sales force more on physician referrals. Can you kind of walk us through a typical patient journey as it stands today to get a personal home unit and then how that might change over the course of this year as Speaker 100:34:05CMS changes take effect? Speaker 200:34:10Well, the definition and activities for CMS will help us a lot. I'll kind of look backwards. Most of our work over the past few years has been very patient driven. We would have a patient and help qualify that patient with our clinical team and then help them through the system. But our referrals really came from patients that really just desperately wanted the benefits of this technology. Speaker 200:34:36The physician community was not really willing to advance this because they didn't want to give false hope to patients. If there was no coverage, they really wouldn't push this with the patient community. So our change in profile to a physician focused approach a little bit here is because it's more scalable and will help us get to the right patients. Our success rate from a patient referred group of individuals is dramatically higher than the individuals who come to us just individually because they get qualified a lot better. For a patient's journey right now, we would encourage and educate them to ask their physician, have their physician guide them through the inclusion exclusion criteria, and then hand them off to our customer service team, which has all the elements that we know we need for a CMS submission, and we help pull that together and get the submission with our internal teams. Speaker 200:35:38And then we work back to the clinic that we originally got the physician or the referral came from and we will do the training there in most cases. And then the product is provided at the end of that cycle. So it's a combination now of the physician as a starting point for many of them, followed by ReWalk's involvement in helping the hard work of processing and preparing a claim that will go through, followed by the clinic training them. And then after that, we have a very good warranty and service program here to make sure these individuals have the device working for the entire 5 year life of the device. So there's the flowchart is much longer than that, but that is a reasonably good verbal explanation. Speaker 400:36:24No, and that makes sense and it's definitely helpful. And our obviously with the patients coming to you is kind of the way that's been historically, obviously you're never going to run Super Bowl ads to try and target all the patients that could potentially be candidates. But in terms of the physicians that you go after, I mean, is that a relatively smaller group of folks that might be X1000 out there that you can easily target or is there sort of a back of the envelope number that we should think about on these your sales force will be going after 2,000 or 10,000 or 500 physicians that really you guys think have the potential to write a lot of prescriptions? Speaker 200:37:23Yes, there's a pretty good variety of the physician base. The core initial one is the PM and R docs, the people who do physical and rehabilitation medicine. As they see these patients particularly early, as patients get a little later in years past their injury, the group becomes more varied with some neurologists and internists. So our initial focus would be a little more in the clinic based. We believe that gives us sufficient numbers for growth. Speaker 200:37:54But over time, getting neurologists and some internal medicine and other groups educated will matter. So I think we have a pretty good early target. It will grow over time for the spinal cord injury side of the business. Speaker 400:38:12Okay. Got it. That's helpful. And then a couple of quick ones. On can you provide the pro form a Alter G revenues for 2023 and the growth versus 2022 or don't you have those available or can provide them? Speaker 100:38:32Pro form a revenue, if you combine the 2 organizations together? Speaker 400:38:36Well, either that way or just AlterGIS kind of a standalone, if you will? Speaker 100:38:43I don't have that in my figure. Speaker 300:38:44Just let me try Speaker 100:38:46to pull that up while we're on the call here. Okay. Speaker 200:38:50Give me a moment. Speaker 400:38:52Yes. No problem. And then just on I guess another one to distract you from the test, but the integration savings that you expect, does that kind of kick in fully during Q1 or does that ramp down into Q2 and beyond or should we just model it as kind of $750,000 savings over the course of the year? Speaker 100:39:20That will phase in over time. That's not all immediate. We should start to see the benefit of that in Q1, but we won't really see the full impact until we move later through the year. Okay. That's helpful. Speaker 100:39:37For the time to kick in. Speaker 400:39:40Makes sense. Okay. Speaker 100:39:42I think that's all Speaker 400:39:43I had. And I'll leave it at that. Speaker 100:39:46And thanks for taking the questions, guys. Thanks, Matt. Thank you, Ben. I'll follow-up with you with the answer to that other question that Speaker 200:39:54you had. Operator00:39:57This concludes our question and answer session. I would like to turn the conference back over to Larry Chiesinski for any closing remarks. Speaker 200:40:07I'd like to thank everyone for joining us today. I started out with a fairly long list of 2023 milestones, and we've very much been a milestone driven company because that was the basis for us to really expand. And this is the year we get to do it, that we are moving to execution phase. We have the right team in place, which is an important part of the integration of the companies, and we have the size and scale to do it. So we very much look forward to presenting this on future quarterly calls, and we ask everyone to please watch us closely. Speaker 200:40:44That's it for today. Thank you, everybody. Operator00:40:46The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read morePowered by