Lifeward Ltd.

Good day and welcome to the Lifeward Third Quarter 2024 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please signal conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. 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 Alam Didar, our Vice President of Finance. Earlier this morning, Lifeward issued a press release detailing financial results for the three and nine months ended September 30, 2024, which, along with this call, discussed 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 meeting of the Private Securities Litigation Reform Act. These forward-looking statements are based on the 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. These 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 dialing 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 -to-date information. And with that, I'll turn the call over to Larry. Thank you, Mike. Welcome,

everybody, and I appreciate your joining today. So filling 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 on 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 bad coverage of another 25,000 as access expands to additional payers. 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 of clinics, and importantly, physical medicine and rehabilitation physicians who prescribe and guide training on our products in up to 17,500 clinics in our direct markets. Let me relate two stories to bring these innovative designs to life. Quote, they change my life, unquote. Well, it's a story of a patient who gained access to Rewalk through Medicare coverage. She notes she had made peace with life in a wheelchair and lived 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 amongst a few. Since Rewalk, she relates a feeling of normalcy working in the kitchen and lists a number of health benefits from Rewalking 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 Altra G's differential air pressure technology and she was able to reduce her weight exercising in the Altra G. 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 continued 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, US leads have expanded 62% over prior year due to our expanded coverage and commercialization efforts to drive adoption and uptake. Due to these efforts, our current US pipeline with Medicare and other US payers 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 in 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 gates 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 in the space are seeing the same impact. We do continue to have optimism here as our third quarter placement 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 aligned in our sales and marketing 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 break even and requires a sufficient pace of Medicare ramp and processing, 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 Plus, which were successfully launched mid-year, 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 phase. 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 standard gap basis as well as a non-gap basis, which excludes the items listed in the reconciliation tables and provided in today's earnings release. I encourage you to reference the gap results and reconciliation tables as I discuss the financials. For Q3, Lifeboard reported 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 exosuits 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 US 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 Q3-24, the Rewalk sales were adversely affected by some delays in attrition of 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 US, 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 I already mentioned, consisted of approximately 70 qualified candidates for future claim submission with Medicare and other payers. These US 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 represents an important pipeline metric. The current pipeline of active rentals consists of 25 cases, which has broken down with 23 in Germany and 2 in the US at VA hospitals. These Rewalk rentals, with some attrition, typically convert to sales within a 3-6 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 these 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 .2% of revenue, compared to $0.9 million, or .6% of revenue, in the prior year. On a non-GAAP basis, adjusted gross profit was $2.6 million, or .5% of revenue, for the third quarter of 2024, as compared to $2.0, or 45.1%, in the third quarter of 2023. This declining gross margin percentage is primarily attributable to lower absorption of factory overhead costs in our 3-month 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 and 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 $25-26 million for 2024. Based on the current recovery and trends thus far in the fourth quarter, LifeOrd 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 physician and patient groups who are actively supporting our initiatives into the commercial and veteran system. AltraG is a great and effective technology and with the 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 $12-13 million per quarter and we are aggressively building to 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 time frame. 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 its 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.

Thank you.

We will

now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you're using a speakerphone, please pick up your hands up before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2. The first question comes from Swaya Pankula Ramakant from HCWayne Wright. 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? It's a good drop since the second quarter. Are there any issues in terms of filing with the CMS and getting reimbursement? Okay,

I'll

start

with

that.

We are comfortable with that guidance, absolutely. We are finding with CMS that the timing for processing is going a little longer than we thought. As I mentioned, the average for the 2024 claims is about 150 days. They have been a little slower to pay for us to get the cash at the back end of this. So those have impacted us a little bit for the time to finish here. Mike,

anything you would add to that? No, I mean, frequently it's a case of just documentation and validation of all of the... These claims when they're submitted are much more complex and much more detailed than claims that we've traditionally done for the VA or for workers compensation insurance. And so there's just... And I think there's an added learning curve on the part of the max to understanding the product and the medical documentation that they're going to require for us to be able to provide. So in some of these cases, there's just a requirement to kind of go back and forth a little bit to provide supplemental information, often which puts us back at the back of the queue again for everything to be processed. So that's sort of the circumstances that we're dealing with. But I think we're confident with education and with higher volumes that this process will come more routine.

Okay. And then with regards to the R or G 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, the call is improving quarter over quarter over quarter. It got off to a little bit of a slower start than we wanted. But I 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've 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 Plus, which we only launched mid-year, and we already have 40 orders in place on that product line. So Altra G is going the right direction.

So one last question from 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 re-lock to be substantial with the number of leads we have and the potential. Remember, only about 150 days or a little more post actually we end up to sell the product. So Altra G, or excuse me, re-lock growth would be the primary driver to get to those kind of quarterly numbers to get us to break even. And in parallel, we expect Altra G to recover between the new product and the acceptance of it in a broader range of centers. Both of those are the growth vehicles. The re-lock is the larger growth vehicle. Altra G 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.

In our case, I would just add too that we've, 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 Altra G 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 re-lock organization.

Thank you. Thank you, gentlemen, for taking more of my questions. Thanks, Ok.

The next question comes from Martin Pullett from FMR Poding. Please go ahead.

Yes, can you hear me?

Yes,

we can. Yes. Okay. Look, it seems that the cash burn considering the very low sales was fairly respectable. But if you could give us some idea of what the fourth quarter burn may look like. The second quarter burn was at 2.5 million, 2.5 thick mills of accounts receivables not collected. Do you see that number declining materially? You had expected previous quarters to suggest this could be in the low single digits, possibly a couple 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 are we going to be able to sustain itself without having to raise additional cash? Yet you are confident that you may not need it. If you would, give us a look into that 2025. I will say one more thing. I think this investor day is very welcome in terms of news that seems unprecedented. You've never done that before. I think that will be something to really look forward to and get to know the company better.

Your first question is 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 for Medicare. But even absent significant payments for Medicare, we're going to see good improvement in the burn rate in Q4. 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 can see into. 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 expect to see some good improvement in the burn rate in Q4.

And

Marty,

regarding the sustainability without additional cash question, we are working to our current cash for both revenue going up and the expenses going down. We've taken all the steps in both cases. The defining uptake element is going to be CMS uptake. And that is something that we've 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 what seems to have troubled the market since the Q2 results came in and the stock got up to $4.20 on what seemingly were good numbers. The stock has been virtually down in 50%. And it seems that maybe the messaging is still the ones that make investors concerned. I'm concerned. Is the cash burn the real number that I think investors are now looking at? Because 2026 may be profitable. But when you talk about 12 to 13 million towards 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, what is the confidence level? X on the revenue side, obviously, the CMS is important. AltruG is already going to be improving. So I'm not even asking about profitability. I'm asking about sustainability here. Well,

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 in 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 that is for you to think about as we kind of transition from 24 to 25.

And Merti, 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. And Rewalk will grow, Altra G has got to recover and then grow some. So they're both showing those trends. If we keep these trend lines, we're on the path we want to be on.

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 saying right now, is that correct?

Yes, if the market can grow, 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 early as fourth quarter will come down remarkably, it's quite a large number, therefore that might be sustained until next year, you hope, with some proving trends on Altra G coming across and the cost reduction program. Okay, I think the market buys that. It sounds like a very reasonable scenario. And certainly third quarter cash burn was impressive enough considering the revenues were quite a bit lower than expected. All right, thank you gentlemen. Thank you Merti.

As a reminder, if you have a question, please press star one. The next question comes from Ben Hayner from 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 re-walk 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 that maybe Altra G slips a little bit from last year's Q4 number?

We're going to have a good Q4 with Altra G. So it helps recover. It's going to be pretty close to a little bit better.

Yeah, 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 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 on 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 sort of, for the time being, that's sort of held up in that same dynamic that we described earlier about the claim review and approval process. So typically Medicare will then notify the secondary payer that the payment is due from them as well. But that is sort of contingent upon everything else being completed first. So it's sort of the same boat right now.

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

We haven't reported the number. It's gone up and down a lot. We're trying to find patients that have it or sometimes encouraging to get it before they go through the Medicare process because they've had open enrollment going on. So we've been trying to help that along. I can get back to you with the 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 settle down. And then on the accounts receivable for the Medicare claims, I think you mentioned that 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 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 ultimately not approved. So we're not taking the full benefit of 100% of each claim that we submit, as you would with any other payer where there's a certain portion that don't get paid. Okay,

that's helpful. It 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. You know, CMS is still learning at the same rate we are, but they are working with

us. Okay, so there's no

big...

Go ahead, sorry. No, we've got the right materials we need. Okay, great. Well, thanks for taking the questions, guys. Okay, thanks, Beth. Any others?

This concludes our question and answer session. I would like to turn the conference back over to Larry Dzezinski 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 to 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 -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 increased the number of leads we have. Our goal is to increase it by multiple 2 or 3x 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 systems of 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. And we need to get patients immediately after their injury understanding that this option is there for them so that either with Medicare, two years later when they become eligible, that they know what the product is and it's available. And 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 or investor meetings after the first of the year. Thank you everybody.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.