Good day, and welcome to the Lifeward Third Quarter 2024 Earnings Conference Call. All participants will be in a listen-only mode. Please note this event is being recorded. I would now like to turn the conference over to Mike Lawless, CFO. Please go ahead.

Thank you, Danielle. Good morning and welcome to Lifeward’s third quarter 2024 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, and Almog Adar, our Vice President of Finance. Earlier this morning, Lifeward issued a press release detailing financial results for the three months and nine months ended September 30, 2024, which, along with this call, discuss certain non-GAAP information. The press release, including relevant non-GAAP reconciliations and a webcast of this call, can be accessed through the Investor Relations section of the Lifeward website at golifeward.com. Before 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 Lifeward management as of today. They involve risks and uncertainties, including those noted in our press release and our 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. Lifeward 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. A replay of this will be available shortly after the 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 the archived webcast, this call was held and recorded on November 12, 2024. Since that date, Lifeward may have made subsequent announcements related to the topics discussed. So please reference the company’s most recent press releases and SEC filings for the most up to date information. And with that, I’ll turn the call over to Larry.

Thank you, Mike. Welcome, everybody, and I appreciate you joining today. Fulfilling our mission of providing access to technology that changes lives and our progress in building towards an enduring financial business advanced during Q3. The Lifeward story consists of two primary businesses: one, focused on a novel system allowing ambulation and improved health outcomes and quality of life for spinal cord injury individuals. And the other, anti-gravity technology for off-weighting individuals for conditioning injury recovery, treatment of neuro disorders, weight loss, and overall health and wellness. We are very excited about our novel exoskeleton technology, the ReWalk Exoskeleton because although the product has been available in the market for a number of years, we are now at the start of commercial expansion as a result of the Medicare coverage that the company was able to gain this past April. Our immediate coverage base in the United States has expanded to over 17,000 individuals with a potential coverage for another 25,000 as access expands to additional payors. Our differentiated anti-gravity technology services a range of users from professional athletes to everyday patients. In particular, those recovering from a broad range of injuries, those seeking weight loss solutions and those with neurological impairments such as Parkinson’s, where restoring gait is so critical. The combination of the products forms a business base with operating synergy, depth of the relationships with clinics, and importantly, with physical medicine and rehabilitation physicians, who prescribe and guide training on our products and up to 17,500 clinics in our direct markets. Let me relate two stories to bring these innovative designs to life. 'They changed my life.' That’s the story of the patient who gained access to ReWalk through Medicare coverage. She notes she made peace with life in a wheelchair and looked to a good life. But when Medicare allowed access, she and her physician decided to try ReWalk so that she could achieve her physical activity goals and gain health benefits, such as improved pain reduction, improvement in social functioning and mental health, and improved bowel health, among a few. Since ReWalk, she relates a feeling of normalcy working in the kitchen and lists a number of health benefits from walking once again. She named her device Luke ReWalker. Another patient suffered from extensive knee pain, and her weight prevented knee surgery to address her pain. With the advice of her physician, she utilized AlterG’s differential air pressure technology and she was able to reduce her weight exercising in the AlterG. This enabled her to subsequently have the knee surgery, which allowed a major improvement in her life. This is one of the growing segments for anti-gravity technology. The company made significant progress during the quarter. Key developments: We continue to grow the business with a 39% increase over the prior year quarter. We had 20 more individuals regain ambulation from ReWalk placements in the quarter. Coverage for ReWalk started with the establishment of payment in April and the process for qualifying documentation, processing, trial, and training takes time. Our range has been broad, ranging from 55 days to over 1,000 days. For cases that were both sourced and completed in 2024, the claims processing time frame has been about 150 days in these cases, which we are working to shorten going forward. We have built an engine to process claims with a dedicated team of clinicians and case managers that will allow us to support the volume we see in the coming quarters. Overall, U.S. leads have expanded 62% over the prior year due to our expanded coverage and commercialization efforts to drive adoption and uptake. Due to these efforts, our current U.S. pipeline with Medicare and other U.S. payors is now approximately 70 qualified contacts, which bodes well for future quarters and drives our optimistic outlook. Turning our focus to the AlterG technologies. While there’s been a lot of good that gives me and should give you great optimism for the future, the business has not delivered on my expectations this year. I am convinced this is a fantastic technology based on the high level of utilization clinics, the direct customer feedback, and supporting scientific literature. It’s an important part of our strategy going forward. However, we came out of the gate slower than we planned in 2024 after the acquisition, which in retrospect should not have been surprising given the amount of change, turnover, and distraction that comes with the consolidation. Secondly, we are being impacted by the delays in capital expenditures, particularly in smaller provider organizations that have been well reported in the industry. Our market intelligence tells us that others are seeing the same impact. We do continue to have optimism here as our third quarter replacement run rate was better than the first half of the year. We have the best product and, to the best of our knowledge, are not losing sales to competitors and the market reaction to our recently introduced NEO model has been strong with about 40 orders to date. We are also aligning our sales and market efforts with how the rehabilitation provider industry is consolidated. We are anticipating a strong fourth quarter for AlterG, which will set us up well for 2025. In 2024, we have focused on operational efficiency. We made an announcement last week about the closure of two facilities and the financial impact. This is the final step with a number of moves to consolidate efforts, leading to a streamlined organization and the ability to focus on driving ReWalk growth. Our $6.7 million adjusted operating expenses in the quarter is our lowest in the previous five quarters. This will improve as we drive ReWalk sales and capture the efficiencies of this latest consolidation. Our model supports the ability to reach breakeven and requires a sufficient pace of Medicare ramp and processes, successful penetration with the new AlterG NEO system, and some recovery of funding activity in the capital equipment markets that we anticipate in 2025. Our R&D focus in 2024 was driven by the launch of the NEO and the NEO+, which were successfully launched midyear, and by the ReWalk 7-0, a system which is much easier to use and adds essential real-time transmission of data on utilization. The 7-0 is under FDA review and in the follow-up question base. We will complete the requested studies with additional data by year-end. We anticipate FDA clearance to follow in the early months of 2025.

I would now like to turn the call over to Mike Lawless for a financial review. Mike? Thanks, Larry. Before I review the results of the third quarter of 2024, I want to remind everyone that I’m going to discuss the results on both a GAAP – a standard GAAP basis as well as a non-GAAP basis, which excludes the items listed in the reconciliation tables provided in today’s earnings release. I encourage you to reference the GAAP results and reconciliation tables as I discuss the financials. For Q3, Lifeward reported earnings – revenue of $6.1 million in the third quarter of 2024 compared to $4.4 million in the third quarter of 2023, up $1.7 million or 39%. Revenue from the sale of our traditional products and services, including ReWalk exoskeletons, MyoCycles, and ReStore exo-suits was $2.5 million, up $1.1 million or 73% from the third quarter of the prior year, driven primarily by an increase in ReWalk system revenue in the U.S. and Germany. Revenue from AlterG products was $3.6 million in the third quarter of 2024, which was an increase of $0.6 million in the third quarter of 2023 when we acquired AlterG in August of that year. During Q3 2024, the ReWalk sales were adversely affected by some delays in some Medicare cases that we had expected would close during the quarter. Additionally, the AlterG sales were affected by the continued softness in capital spending by clinics in the U.S., which impacted the volume of sales leads and conversion rates in Q3. In the third quarter, our pipeline metrics continue to show improvement across the two major product lines. At the end of the third quarter, our overall number of ReWalk cases in process in the United States, as Larry mentioned, consisted of approximately 70 qualified candidates for future claims submission with Medicare and other payors. These U.S. cases are work in process and supplement the cases in process that we have historically reported each quarter in Germany, where we have 45 cases in process at the end of Q3. For the ReWalk systems, active rentals also represent an important pipeline metric. The current pipeline of active rentals consists of 25 cases, which is broken down with 23 in Germany and two in the U.S. at VA hospitals. These ReWalk rentals with some attrition typically convert to sales within a three- to six-month period. For AlterG systems, we ended the third quarter with orders for 74 AlterG systems in backlog, which is the third quarter in a row of sequential increases in the backlog amount. We continue to be encouraged by the strengthening pipeline metrics for both the ReWalk and AlterG systems as these are leading indicators of future growth and evidence of the improving sales effectiveness of our combined commercial resources. Moving to gross profit. In the third quarter of 2024, our gross profit was $2.2 million or 36.2% of revenue compared to $0.9 million or 19.6% of revenue in the prior year. On a non-GAAP basis, adjusted gross profit was $2.6 million or 42.5% of revenue for the third quarter of 2024 compared to $2.0 million or 45.1% in the third quarter of 2023. This decline in gross margin percentage is primarily attributable to lower absorption of factory overhead costs in our Fremont facility due to lower production volumes of AlterG systems and higher labor costs. Moving to operating expenses. GAAP operating expenses were $5.4 million in the third quarter of 2024 compared to $8.8 million in the third quarter of 2023. On a non-GAAP basis, adjusted operating expenses were $6.7 million in the third quarter of 2024 compared to $6.9 million in the third quarter of 2023. This decline is primarily due to lower R&D expense from the conclusion of the development activity for the ReWalk 7. Our GAAP operating loss for the third quarter was $3.2 million compared to an operating loss of $7.9 million in the third quarter last year. On a non-GAAP basis, adjusted operating loss was $4.1 million in the third quarter of 2024 compared to $4.9 million in the third quarter of 2023. We expect our quarterly operating loss to narrow further in the fourth quarter based primarily on greater sales volume and higher gross margins. Moving to the balance sheet. We ended the quarter with $10.7 million in cash and equivalents and no debt. Our cash usage in Q3 was $4.5 million, which showed improvement from prior quarters. As I mentioned on the Q2 earnings call, an important factor affecting our cash burn is the timing of Medicare payments. While we have made some progress receiving payments for prior claims, the overall process for claims review and approval by the MACs continues to be very time-consuming, which impacts the timing of the eventual payments. We’re working with the MACs routinely, and we have confidence that we will eventually streamline and expedite the approvals in the future. Factoring in the third quarter results, we’re revising our 2024 full year revenue expectations to a range of $25 million to $26 million for 2024. Based on the current recovery and trends thus far in the fourth quarter, Lifeward expects its sequential revenue growth to resume this quarter to generate the highest quarterly revenue for the year.

With that, I’d like to turn the call back to Larry for further remarks. Thank you, Mike. To summarize, before answering your questions, we believe in the health benefits of ReWalk to eligible SCI patients, are excited about our technology and see very encouraging trends for growth. We also understand the steps we must take to continue to drive uptake and adoption and are impacted by the time it will take to expand this market to reach its potential. This includes collaborating with key influential physicians and patient groups who are actively supporting our initiatives into the commercial investment systems. AlterG is a great and effective technology and with a combination of revenue recovery to historical levels and the cost reductions from our facility changes, we anticipate it will be accretive to our operations in 2025. The path to profitability requires revenue levels of approximately $12 million to $13 million per quarter, and we are aggressively building towards these targets. The market size, our commercial engine that continues to grow the qualified lead pipeline, medical education on the medical necessity of ambulation, and plans for expanding coverage are the drivers. The efficiency efforts in lowering operating costs completed during 2024 and disciplined expense control going forward are essential elements to reduce our burn rate. Our cash balance of greater than $10 million can support this pathway if market growth occurs within our timeframe. The significant milestones achieved in 2023 and 2024 have created a tremendous opportunity for our company and this industry. We plan to conduct an Investor Day after the end of the year to provide more insight into how we will achieve our commercial goals along with a more in-depth review of our technology and the expansion of utilization. We will announce more detail on the scheduling of the investor event in the near future. Market creation is not easy, and it takes time and resources. The need for these products is very clear and the ability to commercialize is real with coverage established since April of this year. This is absolutely doable. We are committed and on our way to achieve our goals. I’d now like to open the call to questions. Operator?

Thank you. The first question comes from Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.

Thank you. Good morning, Larry. A couple of quick questions. I was not there at the beginning of the call. So I’m just trying to understand with your new guidance, how comfortable are you with that guidance because it’s a good drop since the second quarter? And also, are there any issues in terms of filing with the CMS and getting reimbursement?

RK, I’ll start that. We are comfortable with that guidance, absolutely. And we are finding with CMS that the timing for processing is going a little longer than we thought. As I mentioned, on average, for the 2024 claims is about 150 days. And they have been a little slower to pay, or for us to get the cash at the back end of this. So those have impacted us a little bit for the timing for this year. Mike, anything you would add to that?

No. I mean, it’s a case of just documentation and validation of all of the claims when they’re submitted are much more complex and require much more detail than claims that we’ve traditionally done for the VA or for workers’ compensation insurance. And so there’s just – there’s an added learning curve on the part of the MACs to understanding the product and the medical documentation that they’re going to require for us to provide. Some of these cases require going back and forth to provide supplemental information, which often puts us back at the end of the queue for everything to be processed. So that’s the circumstances that we’re dealing with. But I think we’re confident that with education and higher volumes, this process will become more routine.

Okay. And then with regards to the AlterG business, is there any possibility for a positive surprise in terms of how the revenue run is from that business? And I know you haven’t had too much experience selling that product this year, but from what you have seen, how comfortable are you with how you expected this business to run and it is running at this point?

Well, as we pointed out in the call, it is improving quarter-over-quarter. It got off to a little bit of a slower start than we wanted. But I’d break it into first, the technology is remarkably well received by the market. The holdbacks, I think, are a combination of some of the integration of the company, but we’ve also seen capital equipment sales between us and measuring other companies in the industry as we looked at intelligence, have been limited and slower in 2025 for all capital equipment. But what we have seen, the quarterly improvement, and in particular, as we’re looking at our backlog and our activities here in Q4, we seem to be recovering nicely and expect a very good Q4. And we have the new NEO product and the NEO+, which we only launched midyear, and we already have 40 orders in place on that product line. So AlterG is going in the right direction.

One last question for me, Larry. In the end, you gave some commentary about what sort of revenue run you need to be at to attain profitability. So based on how the business is running at this point, can you tell us how many quarters it would take to get there or at least your expectations?

Well, we don’t have a specific model we put up publicly, but we expect the growth in ReWalk to be substantial with the number of leads we have and the potential. We’re only about 150 days a little more post actually being able to sell the product. So ReWalk growth will be the primary driver to get to those kind of quarterly numbers to get us to breakeven. In parallel, we expect AlterG to recover between the new product and acceptance of it in a broader range of centers. Both of those are the growth vehicles. The ReWalk is a larger growth vehicle. AlterG will get back to historical numbers, we believe, and expect it to grow with the launch of the new product because that gets us into a new market segment. So we forecast that is doable within the cash we have, but it depends on the pace of the uptake.

And RK, I would just add to that, we – as Larry mentioned, we’ve done a lot of effort to streamline the organization further as we announced in the last one of the recent press releases. And we’re very confident that the former AlterG business will be solidly profitable in 2025 at a lower revenue run rate than we had originally anticipated. But at the same time, we are growing it again. So ultimately, it’s a more profitable, leaner, more efficient organization as it’s been integrated into the ReWalk organization.

Thank you gentlemen for taking all my questions.

Thanks, RK.

The next question comes from Martin Pollack from FMR Holdings. Please go ahead.

Yes. Can you hear me?

Yes, we can.

Okay. Look, currently it seems that the cash burn considering the very low sales was generally respectable. But if you could give us some idea of what the fourth quarter burn may look like, was it $2.5 million of accounts receivables and have collected? Do you see that number declining materially? You had expected in previous quarters to suggest this could be in the low single digits possibly a couple of million dollars of cash burn. That’s one point. But clearly, the market has not been buying that, looking at your cash levels and not probably thinking before profitability. How do we – how are we – how is the company to be able to sustain itself without having to raise additional cash to get to our confidence that you may not need it? If you would give us then look into that 2025? I will say one more thing that I think this Investor Day is very welcome in terms of news that is it seems unprecedented. You’ve never done that before. So I think that will be something to really look forward to, and I get to know the company better.

Okay. So your first question, specifically around Q4. We would expect that the burn rate for Q4 will come down quite a bit from Q3. It’s all going to depend to some extent around variables we don’t have a lot of visibility to, which is the degree to which we receive more payments from Medicare. But even absent significant payments for Medicare, we’re going to see good improvement in the burn rate in Q4. I don’t – I can’t really go beyond that in terms of quantifying it because like I mentioned, we don’t have visibility to the payments coming from the MACs. Those are a little less a process that we could see into. So – but I think with the higher revenue volumes, with some other trends that I mentioned earlier, with higher gross margins with our OpEx levels, we would see – we would expect to see some good improvement in the burn rate in Q4.

And Martin, regarding the sustainability without additional cash question. We are working to our current cash for both revenue going up and expenses going down. We’ve taken all the steps in both cases. The defining uptake is going to be the CMS element. And that is something that we have made great progress on. If you look at the 70 patients that are coming into our contact group that will flow into it. Many of those will be in Q4. Many of them will be in 2025, but it’s the right direction for relatively what impacts our cash and our ability to get there.

I guess back to still what seems to have troubled the market since the Q2 results came in and target up to 420, and what seemingly good numbers, the stock has been virtually down 50%. And it seems that maybe the messaging is still the ones that make investors concerned is the cash burn, the real number that I think investors are now looking at because 2026 may be profitable. But what you talked about $12 million to $13 million toward profitability, is there a number that you’re looking at that would be okay in terms of not requiring cash that would be at some lower level? So as you budget 2025, can you – what is the confidence level on the external revenue side? Obviously, uptick – CMS is important. AlterG is already going to be improving, that you can actually get through at least the first couple of quarters of 2025, and maybe then you have a lot of CMS revenues flowing through in the second half of the year. So I’m not even asking about profitability. I’m asking about sustainability here.

Second, I guess one factor that we hadn’t talked about, which might give you a little more insight, too, is that the facility consolidation of Fremont. Not only will that obviously take a lot of costs out of our cost structure as we mentioned in our press release, and it’s going to improve our gross margins, as we mentioned in the press release. It’s also going to help us from an asset utilization, a cash utilization because we will not have the degree to which we hold now inventory on the balance sheet because that will be held by our contract manufacturing partner. So we expect to see, as we move into 2025, that we’re going to kind of work down some of the remaining balance of inventory that we hold on our books. And then going forward, the production and the sale of units are going to be transferred to the new contract manufacturers. So as part of that transition, we will realize some cash utilization benefit and free up some cash out of our working capital that we currently carry on the books as inventory. So that’s another factor for you to think about as we transition from 2024 to 2025.

Marty, other than the expense side, where we’ve done a lot of streamlining that we’re very happy that we believe is going to work, it really comes down to revenue and the growth. The ReWalk will grow. AlterG has got to recover and then grow some. They’re both showing those trends if we keep these trend lines, we’re on the path we want to be on.

So essentially, you’re affirming your notion that you’re not looking to – you don’t think you will require additional cash to get you through 2025. That’s what you’re seeing right now. Is that correct?

Yes. If the market can grow those, if we continue to grow like we think we can, and the market will grow with us. That’s absolutely the case.

And clearly, for that cash burn, even as the early fourth quarter will come down remarkably, it’s quite a large number, therefore, that might be sustained into next year, you hope with improving trends on AlterG coming across and cost reduction program. I think that the market advised that, it sounds like a very reasonable scenario. And certainly, third quarter cash burn was impressive not considering the revenues were quite a bit lower than expected. All right, thank you, gentlemen.

Thank you, Marty.

The next question comes from Ben Haynor with Lake Street Capital Markets. Please go ahead.

Good morning, gentlemen. Thanks for taking the questions. First off, just kind of a point of clarification maybe. I think you mentioned that 20 new patients got ReWalk systems during the quarter. Did you happen to disclose how many of those were Part B patients?

No. We’ve just been given a global number; we haven’t been covering the different areas in which we sell.

Okay. So don’t expect that. And then on the guidance for Q4, does that assume maybe AlterG slips a little bit from last year’s Q4 number?

We’re going to have a good Q4 with AlterG. It’s – so it helps recover. It’s going to be pretty close to a little bit better.

Yes. No, it’s an improvement over Q4 last year.

Okay. That’s helpful. And then just thinking about the supplemental insurance that some of these Part B patients they have, I know it’s taken longer to get paid on a lot of these things. But are you starting to see supplemental insurance get paid for the 20% figure that could be available to you as well? Or is that yet to come?

Well, that sort of gets triggered with the completion of the claim review and processing by Medicare. So that's contingent upon everything else being completed first. We’re in sort of the same situation right now.

Okay. And do you have a sense of how many folks they are delivering these things to do have supplemental insurance? I mean, is it 50%, 60%, 20%? Where does that kind of stand?

We haven’t reported the number. It’s gone up and down a lot. We’re trying to find patients that haven’t had it or sometimes encouraging them to get it before they go through the Medicare process since they’ve had open enrollment going on. So we’ve been trying to help that along. I can get back to you with a more specific number because it’s changed so much. It’s had a lot of range since we’ve been doing it.

Okay. I mean, I guess I don’t need that. I was just more curious about that. I guess, I can wait for that to kind of settle down. And then on the accounts receivable for the Medicare claims, I think you mentioned it. I didn’t quite catch it, but how far do those go back? And at what point do you have to start considering a write-off of some of those?

Well, they don’t go back that far because we’ve only been starting to put those in, as you know, some late last year, but the law for coverage started in January for the lump sum but didn’t start for payment until April. So we expect all the ones that are approved eventually will be paid, and we’re continuing to see a fairly high rate by the time we get through the process for these going through. So we– I don’t see anything in the short term for that.

And we do reserve a portion of the amount that we think we’ll do for the fact that there may be some claims that are not approved ultimately. So we’re not taking the full benefit of 100% of each claim that we submit, as you would with any other payor is there’s a certain portion that doesn’t get paid.

Okay. That’s helpful and makes sense. And then lastly for me on the whole process of getting the reimbursement. Are you kind of developing a sort of checklist or process that you kind of have reasonable assurance that these things are going to go through if you have collected all these certain pieces of data? Or is that still kind of in the process of feedback loops and figuring it all out?

I would say we’ve made tremendous progress, and it’s now in a very late phase. We pretty much know what they want all the way through and have modified it and built our system around it. CMS is still learning at the same rate we are, but they are working with us.

Go ahead, sorry.

No, we’ve got the right materials we need.

Okay, great. Well, thanks for taking the questions, guys.

Okay, thanks Ben. Any others?

This concludes our question-and-answer session. I would like to turn the conference back over to Larry Jasinski for closing remarks.

Thank you, Danielle. Thank you, everybody, for joining us today. I’d like to close with one of the leading indicators we chose to point out today, the 70 leads that we have. That’s a big deal for us. We had essentially zero qualified prior to April because we didn’t know what qualification would be. And I remind you what qualification is. It’s something that meets the screening criteria. It’s a favorable insurance pathway, and they’re motivated to move forward after they’ve been informed about the out-of-pocket responsibility. Those are good things. So it’s a very different kind of base than we’ve had in the past because we’re now building it. I would also emphasize our work on demand creation. Really, this is education of a market. We’ve got to increase the number of leads we have. Our goal is to increase it multiple times to get to larger numbers for the future. We are going to do extensive doctor and clinic lead programs to get to hundreds of patients to flow into our system and leads, and we’re going to work with centers of excellence. We’ll go into some detail on this in the earnings call. But essentially, we still have to change the world. We’ve got to get everyone understanding that walking is medically necessary. We need to get patients immediately after their injury to understand that this option is there for them, so that either with Medicare two years later when they become eligible, they know what the product is, and it’s available. Those are really our focuses going forward. So we appreciate everybody and we are very excited to be able to talk about this in great detail in the investor call, our investor meetings after the first of the year. Thank you, everybody.

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.