Lifeward Ltd. (LFWD) Q4 2024 Earnings Report, Transcript and Summary

Good day, and welcome to the Lifeward Inc. Fourth Quarter 2024 Earnings Conference Call. All participants will be in listen only mode [Operator Instructions]. Please note, today's event is being recorded. I would now like to turn the conference over to Mike Lawless, Chief Financial Officer. Please go ahead.

Thank you, Rocco. Good morning, and welcome to Lifeward's fourth 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 full year ended December 31, 2024, which, along with this call, discuss certain non-GAAP information. I would ask you to review the full text of our forward-looking statements from this morning's press release. We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. A replay will be available shortly after the completion of the call accessible from the dial information in today's press release. The archive webcast will be available on the investor relations section of our webcast. For the benefit of those who may be listening to the replay or the archived webcast, this call is held and recorded on March 7, 2025. Since that date, Lifeward may have made subsequent announcements related to the topics discussed. So please reference to the company's most recent press releases and SEC filings for the most up-to-date information. With that, I'll turn the call over to Larry.

Thank you, Mike. Welcome, everyone. And I appreciate you joining the call. I'd like to begin by commenting on my announcement in February regarding my retirement from the company later this year. I have been part of a remarkable, life saving, changing journey with many incredibly talented people. I am proud of the team and the company I've been a part of for the past 13 years. Lifeward today is a medical technology agents of change that has given people improved health and better lives. I thank every person that has been a part of this journey. I have confidence that Lifeward's Board will find an excellent leader to advance Lifeward into the next phase of growth, and I am committed to ensuring a smooth transition. I look back at 2024 as a year of meaningful achievement that defined long term access to our technologies and launched our pathway towards profitability. The key milestones were; establishment of lump sum payment and a benefit category with CMS in Q1; issuance of a CMS price of $91,032 in Q2 for the ReWalk system; gaining a meaningful contract with BARMER in Germany that sets the standard for providing exoskeletons; achieving new coverage in Hungary; beginning an initiative to expand penetration with the United States Workers' Compensation insurers for the ReWalk system; initiating a national accounts program for the AlterG line; discussions on expanding our contract to enable further penetration with the MyoCycle; launching a new generation of AlterG with the NEO product; completing FDA usability studies and the full submission for the ReWalk 7; increasing operating efficiency by closing two locations; the reduction of our headcount by 35% to right size the business for 2025; annual growth in 2024 of 85% with an $11.8 million increase over prior year sales to reach $25.7 million. It's a lengthy list that when taken synergistically places the company on sure footing for growth and for significantly reducing loss in 2025. We closed the year with record revenue of $7.5 million in Q4. Our parallel focus for 2025 will be maintaining reasonable growth with equal emphasis on reducing our quarterly operating loss each quarter and achieving a loss at or below $1 million in Q4 2025. The reduction in our operating loss will be driven by targeted growth towards our best margin opportunities and operating efficiencies. Examples include the increase in workers' compensation placements, which have a lower level of processing expense and that pay in a shorter cycle and the MyoCycle, where each ReWalk lead we develop can also be considered for a MyoCycle, which has an improved margin and where we have gained expanded distribution rights to provide home units. Specific growth targets for the ReWalk are placements with CMS, further market penetration targeting ReWalk with workers' compensation coverage and with submissions to US commercial insurers. We will also expand penetration of clinic and home sales of the MyoCycles and advancement of AlterG placements in national accounts. The efficiencies are in product mix, near term cost of goods reduction programs and tightly controlled spend levels to match our goals. Operationally for 2025, we have built a sustainable growth plan where we examined all aspects of the business and reduced cost to meet our goals. We also have favorable year-over-year factors that have enabled reduced expenses. They include completion of our significant investment to achieve industry coverage with the Center for Medicare and Medicaid Services or CMS, reduced R&D expenses as we completed major R&D programs with AlterG and ReWalk 7, the final consolidation activities post merger, which results in a full year with reduced head counts and more efficient manufacturing programs in the US and Israel. In addition, our expectations for the AlterG and MyoCycle product offerings are that they will be accretive to our business in 2025 and beyond. Mike will now provide a financial summary and then we can provide more color on the operational goals I have described. Mike?

Thank you, Larry. I'll remind everyone that I'm going to discuss results on both a GAAP and non-GAAP basis, which excludes items listed in the reconciliation tables provided in today's press release. We believe that the non-GAAP results provide a means for investors to better track the underlying performance of the business. I encourage you to reference the GAAP results in the accompanying reconciliation tables as I discuss the fourth quarter 2024 financials. Moving to revenue. Lifeward reported revenue of $7.5 million in the fourth quarter of 2024 compared to $6.9 million in the corresponding quarter in 2023. For the full year '24, Lifeward reported revenue of $25.7 million for an increase of 85% versus the full year 2023. This is the highest quarterly and full year revenue performance in the history of Lifeward and reflects our progress in scaling the business. Revenue from sales of traditional products and services include ReWalk's exoskeletons, Myocycles and ReStore Exo-Suits was $2.0 million in the fourth quarter of 2024, while revenue from AlterG products and services was $5.5 million, the highest quarterly revenue that this product line has since we acquired it in August 2023. The ReWalk sales were below our expectations due to delays in some attrition of Medicare cases that we had expected we would deliver during the quarter. We're working to reduce the cycle times from vetting leads, processing claims and scheduling deliveries. We expect that the growing volume of qualified leads that we are experiencing will bring more predictability to our quarterly performance in this product line. We delivered a strong fourth quarter for the AlterG product line with particularly robust performance from international customers. Spending by clinics in the US has shown stabilization and that trend has continued thus far into the first quarter, giving us more confidence in our expectation for AlterG sales growth in 2025. Next, our pipeline metrics for the ReWalk product line. First, let's talk about cases and process. Our number of ReWalk cases and process in the United States consists of more than 110 qualified candidates for future claim submissions, while in Germany we had 44 cases in process at the end of Q4. Active rentals also represent an important pipeline metric for ReWalk systems. The current pipeline of active rentals consists of 27 cases, which is broken down with 24 in Germany and three in the US and VHA hospitals. These ReWalk rentals with some attrition typically convert to sales within a three to six month period. Next, for AlterG systems, we ended the fourth quarter with orders for 25 AlterG systems in backlog. This figure shows a seasonal decline in backlog from the third quarter of 2024 from the 2024 level as we cleared out as much as possible of the backlog and inventory to end the year. In spite of the lower backlog level at year end, we still see the market demand improving for AlterG and we expect to drive growth in AlterG revenue of about 20% in the first quarter of 2025 versus the quarter of 2024. Moving to gross margin. In the fourth quarter of 2024, our GAAP gross margin was 24.4% compared to 35.5% in the fourth quarter of 2023. This variance was primarily driven by the restructuring charge for the closure of the Fremont manufacturing facility and related expense reduction actions. On a non-GAAP basis, adjusted gross margin in the fourth quarter was 45.4% of revenue compared to 46.9% of revenue in the fourth quarter of 2023. We finished the year with adjusted gross margins slightly below our expectations, primarily due to mix of products sold in the quarter, particularly the higher mix of international AlterG sales, which carried a lower gross margin in the quarter. GAAP operating expenses were $17.1 million in the fourth quarter of 2024 compared to $8.6 million in the fourth quarter of 2023. This variance was largely driven by a $9.8 million impairment charge on our intangible assets recorded as required by GAAP. Under accounting standards, intangible assets with indefinite useful lives and goodwill must be tested for impairment at least annually or in this case, the impairment was triggered by the market value of our equity compared to our book value. Importantly, this is a noncash charge in nature and ultimately does not affect the operating performance of our business. On a non-GAAP basis, adjusted operating expenses were $6.7 million in the fourth quarter compared to $7 million in the fourth quarter of 2023. This improvement is primarily due to lower marketing, general and administrative expenses resulting from prior expense reduction efforts. Our GAAP operating loss for the fourth quarter was $15.2 million compared to an operating loss of $6.7 million in the prior year's quarter. This variance was largely driven by the aforementioned charges. On a non-GAAP basis, adjusted operating loss was $3.3 million in the fourth quarter, which improved versus the $3.8 million loss in the prior year's quarter. Since the end of the year -- we ended the year with $6.7 million in cash and equivalents and no debt. Subsequent to the end of the quarter, on January 8th, we raised gross proceeds of an additional $5 million, which was added to our cash balance. As we will note in our Form 10-K, which we will file later today, we received a going concern qualification from our auditors as part of the 2024 audit process, reflecting their perception of the adequacy of our balance sheet to fund our business. We have already taken a number of actions to address this development. First, we initiated the sustainable growth plan that Larry described earlier to reduce our cash outlays. We believe prioritizing investment in higher margin near term sales will significantly reduce our quarterly non-GAAP operating losses and cash burn rate by the second half of 2025. Second, we are putting in place an ATM facility that will allow us to opportunistically raise capital should we determine that we need to shore up our capital base. We're also exploring other nondilutive or minimally dilutive alternatives so that we can resolve this issue. Turning to our financial guidance. For 2025, Lifeward expects full year revenue in the range of $28 million to $30 million with an adjusted gross margin between 47% to 49%. Following our efforts to rationalize our cost structure, we expect full year non-GAAP operating expenses of $22 million to $23 million, down from $27.5 in 2024. We expect these factors to drive a full year non-GAAP operating loss of $7 million to $9 million. From a quarterly perspective on 2025, the first quarter is our seasonally lowest revenue quarter and we'll also have the highest operating expenses due to the timing of the fees in of the savings initiatives under the sustainable growth plan. After the first quarter, we expect revenue to grow sequentially in each successive quarter from a combination of greater traction in delivering ReWalk systems, seasonally stronger quotation and sales activity for AlterG products and a ramp of sales of MyoCycles as we execute under the expanded distribution agreement with MYOLYN. We expect quarterly operating expenses decline through 2025 as the full benefit of the expense actions taken under the Sustainable Growth Plan take hold. By the fourth quarter of 2025, Lifeward anticipates that the combined effect of the growing revenue and declining operating expenses will result in adjusted operating loss of approximately $1 million. With that, I'd like to turn the call back to Larry for further remarks.

Thank you, Mike. Lifeward has built a portfolio of complementary products with technological innovations achieved with the ReWalk and the AlterG design has resulted in market leadership by addressing key unmet needs. Similarly, the MyoCycle is a more effective and easier to use design that we expect will also develop a leadership position. We believe the market access we have established with multiple avenues of coverage for exoskeletons are efficient distribution channels that have now developed and a leveragable organizational footprint developed over the past two years has Lifeward uniquely positioned to capitalize on the market opportunity before us. We've charted the key tactical thrust for our product offering in 2025. ReWalk will build on lead programs and expand penetration through internal and external partnerships. In late 2024 and in 2025 to-date, we have expanded our US digital media program to obtain thousands of leads. We are also building leads with educational efforts and programs with key opinion leaders and through conducting local clinic days where we demonstrate the ReWalk to potential users. From these US based programs, we presently have greater than 110 leads that are qualified as a pipeline that supports our planned growth. These leads include individuals in Medicare, workers' compensation and with commercial players. We have so far focused on Medicare and the VA. The next stages are expanded reach into workers' compensation, followed by selected submissions to commercial insurers. We announced this week our exclusive partnership with CorLife to provide supply and support for individuals covered by workers compensation. CorLife has an extensive national patient facing organization and will be managing all leads and will process claims for these patients. ReWalk will deliver the systems and provide training as necessary. In the commercial payer segment, we have qualified leads in our pipeline and will selectively submit claims to Medicare Advantage and commercial payers to request prior authorizations on a case by case basis. We also announced this week the expansion of our distribution agreement with MYOLYN. We have expanded our geographic reach and length of the agreement. The new structure allows us to directly supply systems for home referrals from the clinics we work in. Previously, we focused on sales in the VA and on VA users for home placements. In parallel, with increased volumes, we will gain a lower price and better margins. Our AlterG focus is adding a deeper expansion into US national accounts due to the consolidation by those groups in the industry. We have established a pricing contract with one of the largest national organizations and have pilot programs now active with two other groups. Beyond our efforts in our direct markets, we have moved to reestablish distribution channels that have not yet recovered in the post-COVID period. Specifically targets include Australia, Japan and the Middle East. Our path for 2025 is clear. First, continuing sales growth with a mix that is most favorable with our margin goals. Second, implementation of the sustainable growth plan to reduce cost in all areas of the business. Third, we do maintain our reduction expenses from a full year post integration and no new large government policy initiatives or major R&D programs. And fourth, reduction in our loss each quarter in 2025 and at or below $1 million in Q4. This progress in 2025 and the subsequent path for 2026 is a tipping point for the company for long term financial health that was built off the investments and successes in 2024. We look forward to presenting our results each quarter. Thank you for your time today. I'd now like to open the call for any questions. Operator?

Thank you. We'll now begin the question and answer session [Operator Instructions]. And today's first question comes from Yale Jen at Laidlaw & Company.

Larry did a great job and congrats on and the best wishes for things after ReWalk, Lifeward. And my first question is that for the 2025 guidance, how do you see the growth of each component and is the guidance generally more conservative or you think that's okay? So that's my first question. Then I have a follow-up.

And I'd say, for the most part, the guidance reflects across the board growth, across our three major product lines, ReWalk, the AlterG and the MyoCycles. In general, I'd have to say that the contribution is relatively consistent in terms of the three areas. The MyoCycles are the smallest contributor right now to our revenue and probably going to show the biggest percentage growth because of this expanded distribution agreement. We're going to see -- but we will definitely see growth in the other two product lines as well, probably because of the sustainable growth strategy that we've taken. We try to strike a little bit more of a balance between the top line growth and applying more spending discipline. Given that the spending was heavily oriented around driving the growth in the ReWalk business, I'd say that the growth in ReWalk is going to be concentrated more heavily on some of the segments of the business where we think we're going to get paid more quickly and where we're going to have higher return and lower resource consumption. So -- but in general, I would say across the board, we're seeing growth in all three product lines. And I think it'll be more profitable and more efficient growth from those three product lines.

And maybe just one follow up here, which is for the CorLife partnership you just [indiscernible] days ago. The question is that, what do you think the impact of that may have on the worker compensation part, it's just a smooth -- to increase the process, reduce the cost or maybe even increase the lead? I just want to see any kind of sort of quantify -- is there any quantifiable way to look at this partnership in terms of the benefits?

The CorLife program for us was very important, because historically we have limited access to this really important and attractive segment. And given their size and scope, they have great depth and experience in treating and working for this population. So it's a great opportunity for us to have a much larger conduit into workers' compensation. And they also can process these very efficiently so we don't have the expense of that. And we'll get paid in reasonable cycle, they're probably a 30 to 45 day payer. Overall, the workman's compensation market is about 6% of all spinal cord injuries and it's a group we didn't have access to. So we're very excited about this agreement and to get underway.

Maybe just attach one more question that -- I remember the prior conversation that you will have the next-gen ReWalk to be introduced this year. Would that still be the go for this year and any colors on that as well?

We believe it will be a go for this year. We're ready with the product, it's been through all testing, the final submission after some questions from the FDA and one of the rounds were all completed. So that's the mission went in early in this quarter. And we anticipate our clearance sometime in the first half of this year. So that next generation product, our seventh generation, we're proud of that, should be on the market sometime this year, we would hope no later than midyear.

Our next question today comes from Ben Haynor with Lake Street Capital Markets.

Just going back to the revenue guidance and some of the recent announcements, the CorLife being one and the MYOLYN and MyoCycle being another. Is there much factored in to the revenue guidance from those recent announcements or what's the right way to think about those?

I think Mike and I'll both address it a little bit. I'll start, we have factored them in but we factored them in conservatively, because with CorLife, it's a new arrangement for them and for us. But we think it has a very good potential growth for us over the course of this year and particularly as we go into future years. And on the MYOLYN one, we've sold that product for years but we've been very limited where we could go with it, and it has been a great partnership for us with that product. And by having access to sell in all of the places in the clinics where we're trying to place units, we now have the rights to go and sell to the people in those clinics at home, which is a bigger market, 80% of the market is home, about 20% of these clinic. So we believe there's growth in both those areas. And as Mike when he related -- we expect growth in all of them, we will learn how fast the uptake is for each of them as we go.

I would just echo Larry's comments to say too that for the workers' comp market, we have historically had some access but very limited access in that marketplace [Technical Difficulty]…

And pardon me, everyone. It does appear that we have lost our speaker connection. Please stand by. We'll reconnect the line here momentarily, and we will get the call back underway. Thank you. And everyone, we have reconnected our speaker location. Please proceed.

I believe we were responding to Ben's question about the two contracts. I was just going to add that the workers' compensation, to echo what Larry was saying, the workers' compensation market is a very attractive segment for us. It's one where we've had limited access in the past. But through this CorLife agreement, we have a conduit now into a much higher volume of workers' compensation cases. And from a standpoint of the economics of it, it is attractive to us because we have the opportunity now to be able to have all these cases processed on our behalf by CorLife. So we don't need to have the expense and the resources necessary to have the claims processed by us internally. So looking forward to that. And then again, on the MyoCycle side, the home market is 4 times the size of the facility based market where we've historically been operating. So this gives us an opportunity for a much wider, more greater penetration of the overall FES bike market.

And then in the prepared remarks, you mentioned patient attrition for ReWalk. Is there anything specific that you can point to there? I mean, is it the appeals process, is it the patients weren't suitable? Anything that -- any common denominators there or is it just kind of what you expect?

I'll pick those up a little bit. They were -- it was a combination of seasonal. You're going into a period where the clinics are maybe a little more busy around the holidays and trying to get things in. So some these didn't come. And a few of the others, these were essentially deferrals, they weren't necessarily lost patients but patients who either got -- didn't feel well the day that they were supposed to come in or had some other minor issue that they had to wait until it was settled. So they were just deferrals that are not unusual in this particular patient population for some of the challenges they face.

I think we're -- as you're sort of learning that there's probably going to be some -- as the volumes build in that business, that product line, there's probably going to be a fair degree of seasonality in the fourth quarter because of those factors that Larry cited, just the availability of clinic time and the fact that over the holiday [Technical Difficulty].

Our next question comes from Swayampakula Ramakanth with H.C. Wainwright.

Larry, congratulations on your retirement. And you as a true marathon runner have been putting in steady energy behind ReWalk/Lifeward, and I've certainly got into the company to a sustainable growth state, so congratulations on that end as well. And I'm sure I'll be seeing you around in industry. So in terms of questions or my questions on the quarter and the year. So based on your experience with the reimbursements from the Medicare programs, so what are the learnings that you have got into so far? And do you think the cycle, the reimbursement cycle is smooth as of now? And how are you taking this information to the private payers when you're discussing for reimbursement from them?

What we've learned -- the cycle with the Medicare groups has been a little longer than we expected as they learn this particular industry and product line and we anticipate that cycle will shorten. I think sometimes we've given the metrics of numbers of days that this takes and we are looking to cut that down as much as we can. What we have done with the Medicare, it has been a baseline, which has been helpful with this as we go to the privates, because generally -- and the commercial payers, the quality of the package that we have to put together is extensive. So we're finding with CMS, for example, with the workman's comp patients as a comparison as one of the private groups. We have more than enough data for everything they need and they're processing more quickly on the commercial side. We anticipate over time CMS will get more efficient and effective as they know the products. And I think on the commercial side that path seems to be a little bit shorter.

And then, I know, few of the commentators have already asked you questions on the workers' comp side of the business, but my question is a little bit on the strategy. And I know you always had this part of the business segment, but it looks like you're getting to put more resources behind it in terms of trying to get these transactions done. Is this more of a long term strategy so that you can buttress any losses from how the federal government is trying to ask expenses? And so there's a potential for loss on the Medicare side. Is that part of the strategy here or is this natural progression of the market itself that you have an eligibility to?

This is -- it's not a reaction at all to the federal government pieces. We still see those as working in our favor. It's really driven by opportunity. And having a portfolio of products where two of them are now accretive to the business allows us to build the business in a good way, in an efficient way. The field team and organization we have, we've been able to leverage a lot of that with the three product lines. And the ability to grow both of those through the expanded agreement with MYOLYN, because it's a product that's fabulous and we believe we're bringing much bigger resources than they have the ability to do, so we will be able to grow it, which will benefit both us and MYOLYN. And on the AlterG side, we are seeing the market recover and we are also seeing that we had to change the structure to go after these national accounts in many of the chains when historically it's been sold by individual cases. So by resourcing that, we believe we get that business on the track. We expected it to be as an accretive part of the company to help get us to profitability. And combining the three product lines is the quickest and most effective path for this company to get to breakeven.

We do have a follow-up from Yale Jen, Laidlaw & Company.

Just a quick one here. Firstly, in terms of the CorLife collaborations, what's the term of the deal in terms of that, as well as that in terms of the one with the MYOLYN that you will be able to get to the home side of the -- home use side of the business, which is much larger but would that also increase your marketing expense to fully sort of leverage or explore that?

Well, the scope of the CorLife initially is strictly with the ReWalk workers' compensation. And given their size and their depth of connection, they're going places we can't go and it certainly will not increase our marketing expenses as we'll just be using materials directly. And we will no longer be having to pursue those. So we'll actually reduce some of our expense because they'll be taking that on. They are an extensive national network and in just about every major area of the country for workers' compensation and they already have those relationships. So it's really going to be much more efficient for us. And the way the contract has worked, it's much more favorable to us financially, we believe, than trying to do it ourselves.

Would they also get certain profits or other compensation otherwise, it will go to you guys beforehand?

They will -- well, the processing with them is going to be more efficient with them, because they have extensive -- they have these large groups already in place. And the economics of it, we're quite happy with the terms of the deal. We haven't go through the details of it. But we find that it is a more profitable segment for us overall, particularly when you look over the five year life of the product as we see a focus with those groups and a willingness to pay for the things that are required to service and take care of the warranty of the product over a five year cycle. So it's a favorable financial outcome, both for us and for CorLife.

And just the internal [model] that with the expanded -- with the product offer with a much larger market, would that increase your sort of marketing or sales expense?

It will not increase sales and marketing expense. It will increase our revenue.

It 's a greatly simplified business model to work through CorLife as opposed to doing it ourselves, as I already mentioned. So the economics are consistent, if not better, than doing it ourselves.

Thank you. And this concludes the question-and-answer session. I'd like to turn the call back over to Larry Jasinski for closing remarks. Mr. Jasinski, do you have any closing remarks?

Yes, thank you everybody. And what I'd like to do is close a little bit on the 2025 plans. In particular our 2025 Sustainable Growth Plan, it strikes a balance between top line growth and spending discipline, and that we believe that's what's needed in this segment at this point. We will be more selective in the growth we're seeking. We'll prioritize our investments to generate revenue that's higher margin and using lower resources as examples of what we talked about with CorLife. And as we develop the ReWalk market further and we establish more third party relationships with the centers, we will reaccelerate our investments there to stimulate higher, more efficient growth in the future. So we believe this is the right path for where ReWalk is today. And the short term why this means a little less top line growth, it measures into better bottom line performance, which is our key goal for this year. With that, I thank everybody for joining us today and I really do look forward to being able to present the results of what we are set out in the next quarter and the following quarters. Thanks.

Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.