Good morning, and welcome to the Fourth Quarter and Full Year 2023 Lifeward Earnings Conference Call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Mike Lawless, CFO of Lifeward. Please go ahead.

Thank you, Drew. Good morning and welcome to Lifeward’s fourth quarter 2023 earnings call. I'm Mike Lawless, Lifeward’s Chief Financial Officer, and with me on today's call is Larry Jasinski, our Chief Executive Officer. Earlier this morning, Lifeward issued a press release detailing our financial results for the three months and full year ended December 31, 2023. The press release and a webcast of this call can be accessed through the Investor Relations section of the Lifeward website at golifeward.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events, and the company's future performance may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Lifeward’s management as of today and involve risks and uncertainties including the risks noted in our press release and our filings with the Securities and Exchange Commission. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. 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 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 an archived webcast, this call was held and recorded on February 27, 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. Good day to all. 2023 was a very successful year, achieving milestones that have set us up for exciting growth and expansion. Our investment and success in gaining Medicare payment for exoskeletons, acquisition of commercially successful and highly innovative antigravity products, the strategic building of a scalable organization with the combined talent of the new entity, Lifeward, and ongoing technology leadership with new products are the key milestones of 2023. We believe 2024 is our year to capitalize on these achievements as we will move forward with our sales strategy. In addition to revenue growth, we are poised to leverage our existing operations to minimize our costs, putting us on a path to profitability in 2026. The key highlights for 2023 and the fourth quarter include a 151% increase in annual revenue to $13.9 million in 2023, a 216% increase in Q4 revenue to $6.9 million from prior year Q4. The rebranding of the company as Lifeward to reflect our vision and mission. Integration of the commercial and operational resources of the former ReWalk and AlterG businesses to unify the teams and leverage the inherent strengths of both organizations, resulting in $3 million in annual net savings to be realized in 2024. A public presentation at the November 29 HCPC session, where we stated our case for higher price reimbursement due to the advancements in technology since our original application in 2019. Importantly, we achieved a Medicare reimbursement structure for the ReWalk personal exoskeleton in 2023. We also established internal infrastructure to meet requirements to process Medicare claims. We developed and gained FDA clearance of breakthrough products for strand curve climbing technology and moved forward with innovative new designs of antigravity technology to launch mid-2024 and afterwards. Now, as we turn to 2024, final pricing for our breakthrough exoskeletons is expected in the coming weeks and will take effect on April 1, 2024. In preparation, we have completed roughly 35 submissions to date and plan to submit another 60 to 75 claims over the course of 2024. As clinicians support developments, we intend to expand our supporting infrastructure appropriately. Both the pace and success of our submissions for reimbursement will define the rate of growth for exoskeletons in the last three quarters of 2024 and into 2025. For 2024, with our AlterG anti-gravity systems, we are preparing for a mid-year launch of a new system designed specifically for the needs of smaller private practice clinics, where we see opportunity for growth. Across the fleet, 2023 and early 2024, we completed reorganizing as a single operating entity with the name Lifeward. How do we describe Lifeward? We're not just selling products, we're driving a movement. Lifeward exists to break barriers, redefine possibilities and to guide individuals towards horizons they might have deemed unreachable. Lifeward is not just a name; it's a call to action and an invitation to redefine what's possible. Lifeward aspires to become the unrivaled global leader in pioneering life-changing solutions. And our mission is to relentlessly drive innovation to change the lives of people with physical limitations or disabilities by improving their daily lives. Our values are best summed up as being driven, optimistic, empathetic, savvy and results-focused. We will offer solutions in the form of multiple product offerings that match our mission and operate as a profitable, growing entity. How will we change the organization? I can say that we have scaled our capabilities to support our growth and penetration goals. In the field, we now have a single sales organization of 18 direct sales individuals covering the US, Canada and Germany. We doubled our supporting field clinical staff, have a US network of over 30 field service providers, along with 19 distributors in the EU and 22 distributors for the rest of the world. For internal customer support, we have a dedicated medical director, an internal clinical customer support team to help each inquiring Medicare patient or physician, and have an experienced and structured reimbursement processing team and resources to maintain government, medical and societal affairs focus for industry development. We have quality and operations efforts to meet our targeted sales goals. With the combination of the two companies, we have an experienced senior management team in all key areas with a track record of success. Simply stated, we are ready to take on this commercial plan and achieve our goals. Where will these technological achievements, government policy successes and new organization take us? First, they remain consistent with our skills and our mission as innovative, life-changing products combined with exoskeleton coverage access in our two largest markets. We anticipate sales growth to achieve annual revenue of $28 million to $32 million, depending on the pace and case acceptance level we achieve with Medicare. In parallel, we will reduce our operating loss each quarter in 2024 based on revenue growth, increasing gross margin contribution, gains from cost reduction efforts in 2023 and 2024 and synergistic leveraging of our expenses with a broader product offering. We forecast reaching profitability on our current cash in 2026. I'd now like to turn the call over to Mike Lawless for more financial detail.

Thanks, Larry. Before I review the financial results, I want to remind everyone that our fourth quarter GAAP results include various costs and expenses related to the acquisition of AlterG, which can obscure visibility to the underlying operational performance of Lifeward. In order to facilitate understanding of both the GAAP results and the operational results of Lifeward, I want to discuss our performance in the fourth quarter of 2023 on both a GAAP and non-GAAP basis, which excludes the purchase accounting adjustments, transaction expenses, restructuring charges, rebranding and integration costs, inventory charge and stock compensation expense. The reconciliation of the non-GAAP to GAAP results is provided in today's earnings release, and I encourage you to reference these tables as I discuss the financials. Moving to revenue. Lifeward reported revenue of $6.9 million in the fourth quarter of 2023 compared to $2.2 million in the fourth quarter of 2022, up $4.7 million or over 200%. The increase in revenue is attributable to the acquisition of AlterG. Excluding AlterG sales, the fourth quarter of 2023 revenue was $2.2 million, up $0.7 million sequentially from the third quarter of 2023 and in line with the $2.2 million reported in the fourth quarter of 2022. ReWalk Exoskeleton revenue in Q4 2023 was flat versus Q4 2022 on the same number of units sold, while the revenue from the sale of MyoCycle FES training cycles declined slightly, but was offset with an increase of revenue from ReStore units. Turning to our pipeline metrics. Our pace of active rentals consists of 24 cases, down two from last quarter, which is broken down with 21 in Germany and three VHA rentals. As of December 31, 2023, our overall number of ReWalk cases in process was 70 with 49 in Germany and 21 in the US. We ended the quarter with orders for 46 AlterG systems in backlog, which is lower than the backlog at the end of Q3 2023 due to our internal focus on our commercial reorganization and integration activities. We expect the AlterG backlog to return to higher levels in the coming quarters. As Larry discussed earlier, we expect to have submitted a cumulative 35 claims to Medicare by the end of February for reimbursement of ReWalk systems. To date, one of these claims has been paid, and we expect that more will begin to be processed and paid by the Medicare contractors in the near future. This revenue from Medicare will be additive to the revenue from our traditional pipeline of VHA and workers' compensation cases. Moving to gross profit. In the fourth quarter of 2023, our GAAP gross profit was $2.4 million or 35.5% of revenue as compared to $0.7 million or 30.9% of revenue in the fourth quarter of 2022. On a non-GAAP basis, gross profit was $3.2 million or 47% of revenue for the fourth quarter of 2023 as compared to 52.8% for the fourth quarter of 2022. The fourth quarter a year ago had a very favorable mix of product sales and favorable material costs which contributed to the higher gross margin. In Q4 2023, AlterG gross margin was accretive to the overall Lifeward consolidated gross margin. Moving to operating expenses. GAAP operating expenses were $8.6 million in the fourth quarter of 2023, up $2.9 million or 51% compared to $5.7 million in Q4 2022. Within the major OpEx categories, GAAP R&D expenses were $1.3 million in Q4 2023 as compared to $1.1 million in Q4 2022. On a non-GAAP basis, R&D expenses were $1.1 million and flat with the amount in the fourth quarter of 2022. AlterG contributed $0.5 million in the most recent quarter, while the R&D expenses for ReWalk declined due to lower spending on subcontractors and consultants from the conclusion of the Stairs and Curbs project and reduction in spending on the ReWalk 7 project since we are at the final stage before FDA submission. GAAP selling and marketing expenses were $4.8 million in Q4 2023 as compared to $2.7 million in Q4 2022. On a non-GAAP basis, selling and marketing expenses were $4 million, up $1.4 million or 52%. The majority of this increase came from the addition of the AlterG business, which contributed $1.3 million in selling and marketing expenses. The rest of the increase was primarily due to higher consulting and professional service fees associated with CMS reimbursement-related activity. GAAP general and administrative expenses were $2.4 million as compared to $1.9 million in the prior year's quarter. On a non-GAAP basis, G&A expenses were $1.9 million, up $0.3 million or 17%. The addition of the AlterG business contributed to all of this increase, while G&A for the ReWalk business declined. Our GAAP operating loss for the fourth quarter was $6.1 million compared to an operating loss of $5 million in the fourth quarter of 2022. The non-GAAP operating loss was $3.8 million in Q4 2023 as compared to $4 million in Q4 2022. The fourth quarter 2023 results also reflect a $1.1 million sequential improvement in the operating loss versus Q3 2023. As with the case last quarter, the AlterG business had a positive operating profit in Q4 and contributed to the improvement in the non-GAAP operating loss. Moving to the balance sheet. We ended the quarter with $28.1 million in cash and cash equivalents and no debt. Cash used in operations in Q4 was $4.4 million, which includes some transition and integration costs. Next, I want to provide an update on the status of our listing requirements for NASDAQ. As you know, back in October, we were notified by NASDAQ that our second grace period to regain compliance with the $1 bid price requirement had expired. We requested and received extensions from the NASDAQ Hearings Panel through March 31, 2024, based on the anticipated announcement of the final payment rates by CMS for exoskeletons, which we believe would provide the clarity and certainty investors are seeking and positively impact our stock price such that an inverse stock split would not be necessary. At this stage, there are no further extensions available for us under the NASDAQ listing rules. We continue to expect a favorable stock response once the final payment rate is announced by CMS, but the timing of this is uncertain relative to our NASDAQ compliance deadline. We have our contingency plans in place for our Board to authorize a reverse stock split should the CMS announcement not take place in time for our deadline with NASDAQ. Okay, now, moving to financial guidance. As a reminder, Medicare has still not provided a final payment rate for exoskeletons nor do we have the timetable at which the Medicare claims will begin to be processed and paid by the MAX. These two factors have a significant influence on our potential 2024 results. The following guidance is our attempt to factor in the uncertainty related to these two variables with the appropriate conservatism. For the full year 2024, we expect revenues of between $28 million to $32 million. The growth in revenue is driven by a full year's contribution from the AlterG business augmented by a new product introduction that we expect in mid-2024 of the new entry-level model of the AlterG. Additionally, we expect ReWalk revenue will benefit from the expansion of the market coming to the new benefit category and payment rate by Medicare starting on April 1st. We expect non-GAAP gross margin to expand to the high 40% range, driven by volume leverage from a higher level of shipments of ReWalk devices and product cost improvements in the AlterG systems. We expect non-GAAP operating expenses to decline from the fourth quarter 2023 run rate level, and our non-GAAP operating loss will be reduced to the low double-digit millions. We expect to exit 2024 with a significantly reduced quarterly operating loss, which provides visibility to achievement of future operating profit. Since we still have low visibility to the timing and pricing of Medicare payments, our guidance does not anticipate any Medicare revenue in Q1 2024. Additionally, the first quarter is seasonally the lowest quarter of revenue for the AlterG Systems, and the new combined commercial team, which just came together in January, will also need time to achieve sales traction across the product portfolio. Taking these factors into account, we expect revenue in Q1 2024 to be in the range of $5 million to $5.5 million. In the quarters that follow, we expect revenue will increase sequentially on Medicare claims beginning to be paid and the seasonal increase in AlterG revenue, supplemented by the new AlterG product introduction expected in mid-2024. With that, I'll turn the call back over to Larry for further remarks.

Thank you, Mike. I would now like to provide more detail on our market goals, our ongoing technological advancements, our commercial operations, and our financial goals. First, the success of CMS is something we seek to build on in the U.S. market. We will work with CMS to optimize the submission process. In parallel, we will initiate interaction with U.S. private commercial payers and Workers Compensation groups to seek similar coverage as provided by CMS. These processes are a multi-year approach and we will update accordingly as they progress. Technology advancement is central to our mission and to our growth expectations. Mid-year, we plan to launch a new AlterG anti-gravity model, which has features and pricing specifically designed to address the needs of smaller clinics who have previously been unable to access anti-gravity technology as a treatment option for the patients due to limited budgets and other constraints. We see this as an underserved market where this design can advance penetration for these smaller clinics. We have also progressed on technology that expands clinical applications with new features for larger VM Centers. We have not yet established a specific launch date for this product but seek to launch in 2025. The ReWalk Personal Exoskeleton product line will soon be filing an FDA submission for a new iteration of the ReWalk design. It is part of the constant advancement of adding new features and improvements from our extensive interaction with our users. The timing for this launch will be defined by the FDA clearance, and we are hopeful this launch will be able to occur in 2024. In addition, separate efforts are being made to establish our longer-term pipeline for advancements with exoskeletons, and we have incorporated artificial intelligence or AI into a functional prototype to improve usability and add new capabilities. This project is currently focused on testing and development, and a timeline to launch will be developed accordingly. For commercial execution, we are shifting our US sales team's focus to be more physician-oriented as a key element for referrals and market development. This utilizes our larger sales team with deeper clinic-driven connections with a broader product offering. Marketing has organized supporting scientific material while working with our medical director to shift this to a more scalable approach. We will educate and assist the medical community to efficiently identify the eligible individuals who would benefit from ReWalk's exoskeleton now that Medicare coverage is available. I would now like to address our operational direction for 2024. We expect revenue of $28 million to $32 million, and as CMS progresses with our current 35 submissions and the additional 60 to 75 that we will do this year, we will be able to better define the pace and impact on the reduction and eventual elimination of our operating loss as the year goes on. We will adjust and work to reduce our operating losses each quarter in 2024 with sales growth to obtain synergy from combined operations and increased activity to reduce the cost of goods and improve margins as part of the process as we gain volume. Our goal is profitability in 2026 on our current cash. We set many milestones in our strategic plan over the past few years, and we have successfully reached them. We are optimistic and confident that Lifeward can now achieve the dream of access to life-changing technology with parallel financial success. Thank you, everybody, for your time today. Operator, questions please?

Yes. We will now begin the question-and-answer session. The first question comes from Swayampakula Ramakanth with H.C. Wainwright. Please go ahead.

Thank you. This is RK from H.C. Wainwright. Good morning, Larry and Mike. I have a few questions. To start with the CMS reimbursement, I initially thought that by the end of this month we should have something in place. Is that still the expectation? What kind of communications are you currently having with CMS to ensure that we will have everything ready for it to be effective on April 1?

Our expectation is consistent in that we are expecting the rules to take place on April 1, as it always has. We recognize with CMS that there were more than 30 categories of products in the fixed suit meeting, and we were one of those. So I think they have a lot of detailed answers to get all of the categories done even though most of them have nothing to do with us. We're just a part of an overall package. So our confidence is very high. April 1 is our effective date. The timing, we also had expected it by now, and we anticipate it any day in order for the Max to have time to implement the fee schedule into their systems. But I don't have it as of this call. But as soon as they do, you're going to see our press release.

Thanks for that. At the end of last year, you completed the site submission to one of the Max, which indicated that your systems are set up well and running smoothly. Since then, have there been any further submissions, or are you waiting for the final ruling before proceeding with any additional submissions?

No, we continued and restarted submissions on January 1, when it switched over to a lump sum payment. So we did put them on hold in the latter part of Q4. And we will finish the end of February with a total. This will include the earlier ones of about 35 submissions in, roughly half of them here in the first part of this year, the other half were from last year. And again, our timing was simply now we know at least all the later ones are under lump sum payment designation. And we will continue to build our pipeline to try to put in roughly 60 to 75 additional submissions this year.

Okay. Thank you. And then I want to – what commentary you have in terms of growth expectations in Germany and Europe in general, I did hear on the call, you were saying that you have about 18 or 19 sales folks out there – distributors out there. So how are they helping you to grow the business in Europe?

One of the primary advantages of the addition of the AlterG technologies is it built our network in Europe and Asia that we didn't have. So for the AlterG product line, now that they are fully focused on the field and no longer involved with the elements of the sale on acquisition. We expect that they are going to see reasonably good growth in the European and Asian markets through the size and scope of their distribution organization. For our direct team in Germany, we're optimistic on both sides that the AlterG will continue to do well in Germany. It's been a very well-accepted product there. And we see the extra seltor market beginning to grow in Germany as well as we see an increase of up to 50% year-over-year in Germany.

Perfect. So my last set of questions on AlterG, in general, what is the revenue dynamics as we go through the year? And then for the new product that you're planning to launch in mid-2024, what sort of a market is out there for that product? Thanks.

Yeah. So we expect that the sales of the AlterG systems will grow sequentially as we move through the year. That's typically been the historical pattern for that business, whereas the Q1 is the lowest quarter, and then it gradually builds as we move through the year. I guess that's a function of the order patterns and the purchasing patterns of the customer base. But I think that will be particularly true this year because of the fact that the introduction of the new NPI right around mid-year when we're expecting that. So the second half of the year, we'll get the benefit of that new product introduction in addition to the normal seasonal growth that we typically see with that product line.

Okay. And regarding the new product, I'll step back for a second and remind you that the ones that we're doing so well with AlterG and entering a new segment is what we're excited about. But the product is extremely well accepted in the professional sports arena, and we expect that business to stay very steady. And we also have a healthy business in the larger rehab clinics. The area we've not been able to penetrate heavily is the smaller private practice places because the features of the products we build into the pro sports, for example, are for 300-pound people that might run 15 miles an hour in the larger rehab clinics. We have a lot of other features and capability. But the smaller private practices don't need that level of capability. They're not training pro athletes. They can really work well with the audience. So we have built the features around something that will allow us to begin to penetrate that segment, which is about 15,000 clinics in the US that is, at this point, really not penetrated. So it's rounding out our presence in all of the major markets where this technology can be used. So we're excited about it this year. We'll begin shipping this product right around midyear, and it is a significant part of our growth trajectory for AlterG.

Thanks. Thank you very much for taking my questions. Good luck.

The next question comes from Ben Haynor with Alliance Global Partners. Please proceed.

Good day, gentlemen. Thanks for taking the questions. Can you hear me, okay?

Yes, yes, Ben.

Yes.

Great. I wanted to inquire about the guidance regarding how much CMS revenue is included. If I estimate based on your 35 submissions that you could get paid for, and considering the $60 million to $75 million you plan to invest this year, even at the initial amounts, it could be in the high single-digit millions or low double-digit millions. What’s the best way to evaluate this? Additionally, I assume that any CMS revenue included is based on the preliminary reimbursement figures currently available.

Hi, Ben, it's Larry. Yes, we have presently modeled this using a combination of our submissions we're making and the preliminary pricing, although we think that will be higher. So we have the 110 claims total. So, the 35 already in place, the 75 new ones, so that's our goal, 60 to 75, but we expect around 100 or more claims or submissions. The percentage that we are looking for payment for 2024, the reason we gave a range is somewhere between 10% and about 40%, we think, will be paid in 2024 calendar year, and we believe the balance will be paid in the 2025 period. So this is partially building our pipeline for 2025. We're being conservative in our estimates because we can't completely predict the pace of things with CMS, and that's how we built that.

So there's upside if they hit that 10% to 40% proportion is higher, and obviously, if the reimbursement figure is higher, is that fair?

Yes, we'll take the sale whenever we can get it. So, yes.

Okay. Fair enough. And then you mentioned kind of refocusing or focusing the sales force more on physician referrals. Can you kind of walk us through a typical patient journey as it stands today to get to a personal home unit and then how that might change over the course of this year as CMS changes take effect?

The definition and activities of CMS will be very beneficial for us. Reflecting on the past few years, most of our efforts have been focused on patients. We would assist patients in qualifying with our clinical team and guide them through the system. However, our referrals primarily came from patients who wanted the advantages of this technology. The physician community was hesitant to promote this because they didn't want to give patients false hope when there was no coverage, so they didn't actively refer patients to us. Our shift towards a physician-focused strategy is due to its scalability and effectiveness in reaching the appropriate patients. Our success rate with patients referred through physicians is significantly higher than with those who come to us individually, as they tend to qualify better. Currently, we encourage patients to speak with their physicians to navigate the inclusion-exclusion criteria, and then we connect them with our customer service team, which has all the necessary components for a CMS submission. We assist in compiling that information and processing the submission with our internal teams. Afterward, we return to the clinic from which the physician referral originated, where we provide training in most cases. Finally, the product is delivered at the end of this process. The procedure now involves the physician as the initial contact, followed by ReWalk's support in managing the complex claim process and clinic training. We also have an excellent warranty and service program to ensure that users have a functioning device throughout its five-year lifespan. While this overview is simplified, it offers a good verbal description of the flow.

No, and that makes sense, and it's definitely helpful. With patients coming to us in a way that's been historically consistent, it's clear that we won't launch Super Bowl ads to target all potential candidates. Regarding the physicians we approach, is that a relatively smaller group, perhaps a few thousand, that we can easily target? Or is there an estimate we should consider regarding the number of physicians your sales force will pursue, whether it's 2,000 or 10,000 or 500, that you believe have the potential to write a significant number of prescriptions?

There's a pretty good variety of the physician base. The core initial group consists of PM&R doctors, who specialize in physical and rehabilitation medicine. As these doctors see patients, especially as they age and experience more complex injuries, the group becomes more diverse, including neurologists and internists. Our initial focus will be more clinic-based, which we believe will provide sufficient numbers for growth. However, over time, attracting neurologists and internal medicine specialists will be important for the group's education. I think we have a solid early target, which will expand over time for the Spinal Cord Injury business.

Okay, that's helpful. Can you provide the pro forma AlterG revenues for 2023 and how they compare to 2022? Do you have that information available?

The pro forma revenue, if you combine the two organizations together...

Well, either that way or just AlterG as kind of a standalone, if you will.

I don't have that in my fingers; let me try and pull that up while we're on the call here.

Sure. Regarding the integration savings you anticipate, do you expect it to fully materialize in Q1, or will it extend into Q2 and later? Should we consider it as approximately $750,000 in savings for the quarter or across the entire year?

That will phase in over time. That's not all immediate. We should start to see the benefit of that in Q1, but we won't really see the full impact until we move later through the year.

Okay. That’s helpful. And …

... I'll follow up with you, with the answer to that other question that you had.

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

I'd like to thank everyone for joining us today. I started out with a fairly long list of 2023 milestones. And we've very much been a milestone-driven company because that was the basis for us to really expand, and this is the year we get to do it. We have the right team in place, which is an important part of the integration of the companies. And we have the size and scale to do it. So we very much look forward to presenting us on future quarterly calls. And we ask everyone to please watch us closely. That's it for today. Thank you, everybody.

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