Earnings Call Transcript - LFWD Q2 2024

Operator, Operator

Good day, and welcome to the Second Quarter 2024 Lifeward, Inc. Earnings Conference Call. This event is being recorded. I would now like to turn the conference over to Mike Lawless, Chief Financial Officer. Please go ahead.

Mike Lawless, CFO

Thank you, Megan. Good morning, and welcome to Lifeward's second 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 and six months ended June 30, 2024. The press release and a webcast of this call can be accessed through the Investor Relations section of Lifeward's website at golifeward.com. Before we get started, I'd like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Lifeward management as of today and involve risks and uncertainties, including those noted in our press release and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Lifeward specifically disclaims any intent or obligation to update these forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by law. A replay will be available shortly after the completion of the call, accessible from the dial-in information in today's press release. The archived webcast will be available in the Investor Relations section of our website. For the benefit of those who may be listening to the replay or the archived webcast, this call was held and recorded on August 15, 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. With that, I'll turn the call over to Lifeward's CEO, Larry Jasinski.

Larry Jasinski, CEO

Thank you, Mike. Welcome, everybody, and I appreciate you joining us today. Q2 was entirely a proof of execution quarter. After years of strategic efforts to gain coverage and access to build an infrastructure and scale to operate, and essentially leading our company and our industry through a door that enables us to create an enduring operating entity, we are succeeding. Revenue has grown to $6.7 million in Q2, an increase of 402% over Q2 2023. We achieved record revenue with 20 ReWalk placements in the quarter. We have now received over $600,000 of our Medicare receivables as the payment system has started flowing. In the first half of 2024, we sold more ReWalk systems than we have in any other prior full year. Our operating losses stayed level year-over-year with a much larger commercial footprint in place this year, and multiple waves of cost efficiency will begin to flow into our expense results in the next few quarters to reduce our cash burn. Part one, revenue. Revenue was driven by the successful placement of the ReWalk systems and the addition of anti-gravity technology in Q2. The gate to Lifeward's growth was simply the achievement of Medicare approvals. We expect another record quarter for ReWalk in Q3 due to the successful efforts in advocating and establishing a government policy. The anti-gravity technology grew from improved execution as our newly combined sales team gained their footing over Q2 with a significant increase in deliveries. This segment also had some headwinds with high interest rates and consolidation of clinics, which impacted the pace of AlterG placements. Our new product, launched in June, is expected to increase our growth as it offers features at a price point that will allow more clinics access to this innovative technology. Part two, ReWalk record placements and payment. A great first quarter, with 20 people gaining access to walking in everyday life once again. The infrastructure we established is working and has the capacity to manage our growth targets. Examples of execution that are equally important to our achieved market access include significant Medicare receivables that were paid over the last few weeks. Some of our most recent submissions have made progress in submission to payment in 45 days. The submissions prior to the final establishment of government policies are lagging but are in the process of getting paid. Part three, operating loss trajectory is going in the right direction. The combination of revenue growth, margin gains, and a series of operating efficiencies are required with our push to profitable breakeven operations. The combination of increased unit sales volumes and improved margins with the new NEO anti-gravity and operating changes made in late 2023, during 2024, and that will start in 2025, are all key elements in achieving lower operating costs while still growing the company overall. In summary, Q2 has proven our strategy has been well supported by our execution following our achievement with Medicare policies as a part of our mission. We reaffirm our revenue guidance of $28 million to $32 million for the year and believe our directional targets for ReWalk systems expansion in the coming years will be achieved. We continue to see a path with our models that get us to cash flow breakeven and ensure adequate working capital with our current cash. The rate of market growth and uptake is both our opportunity and our risk. I'd now like to turn the call over to Mike for more financial details. Mike?

Mike Lawless, CFO

Thank you, Larry. Before I review the financial results of the quarter, I want to remind everyone that our GAAP results for the three and six months ended June 30, 2024, contain financial elements that can obscure investors' visibility into the underlying operational performance of Lifeward. In order to facilitate the understanding of both the GAAP results and the operational results of Lifeward, I'm going to discuss the results of the second quarter on both a standard GAAP basis as well as a non-GAAP basis, which excludes the items listed in the reconciliation tables provided in today's earnings release. I encourage you to reference the GAAP results and the reconciliation tables as I discuss the financials. Lifeward reported revenue of $6.7 million in the second quarter compared to $1.3 million in the second quarter of 2023, up $5.4 million or approximately 400%. Revenue from the sale of our traditional products and services, including ReWalk Exoskeletons and MyoCycle, was $3.1 million in the second quarter of 2024, up $1.8 million or 72% from the second quarter of 2023, driven primarily by an increase in ReWalk system revenue from the expansion of access through Medicare coverage. Revenue from AlterG products was $3.6 million in the second quarter, which was a sequential increase of $0.8 million from the first quarter of 2024. We're encouraged with the improvement of AlterG sales as compared to the first quarter, and we expect further sequential improvement of revenue in the third and fourth quarters as our sales effectiveness continues to improve from the integration of our commercial resources. Our pipeline metrics continue to show healthy activity in the second quarter across our two major product lines. For ReWalk systems, at the end of the second quarter, our overall number of ReWalk cases in process was 89, with 54 in Germany, consisting of 29 pending insurance claims and 25 court cases, and 35 in the U.S., many of which are for Medicare beneficiaries. The current pipeline of active rentals consists of 30 cases, which is broken down with 26 in Germany and four in the U.S. in VHA hospitals. For AlterG systems, we ended the second quarter of 2024 with orders for 63 AlterG systems in backlog. Subsequent to the end of the quarter, we saw a pickup in order activity and our AlterG backlog currently stands at 104 units, which represents orders that will ship primarily in either the third or the fourth quarter of this year. Gross profit: Moving to gross profit, in the second quarter of 2024, our GAAP gross profit was $2.8 million or 41.1% of revenue compared to $0.6 million or 43.1% of revenue in the second quarter of 2023. Non-GAAP gross profit was $3.1 million or 46.9% of revenue in the second quarter as compared to $0.6 million or 43.3% of revenue in the second quarter of 2023. The primary factor that contributed to the improved gross margin in the second quarter of 2024 on a non-GAAP basis was the higher volume of ReWalk product sales, which resulted in greater absorption of operations and overhead costs. GAAP operating expenses were $7.2 million in the second quarter of 2024 compared to $5.7 million in the second quarter of 2023. Non-GAAP adjusted operating expenses were $6.9 million in the second quarter compared to $4.5 million in the second quarter of 2023. The increase is primarily attributable to the acquisition of AlterG, which added headcount and outside spending and investment in additional commercial resources to process Medicare claims for ReWalk. We continue to take action to achieve expense efficiencies, and we expect further decline in operating expenses in the second half as these actions take effect. Our GAAP operating loss in the second quarter was $4.4 million compared with an operating loss of $5.2 million in the second quarter of 2023. Non-GAAP operating loss was $3.7 million in the second quarter as compared to $3.9 million in the prior year's period. We expect our quarterly operating loss to narrow further as we move through the second half of the year as our sales volume continues to grow. We ended the quarter with $15.1 million in cash and equivalents and no debt. Our cash usage in Q2 was $5.6 million, which was an improvement from the first quarter, but higher than we expected. The two major drivers of the cash burn in the second quarter were an increase in receivables of $1.8 million and an increase in inventory of $1.1 million. I will cover each of these separately. First, with accounts receivable, at the end of the second quarter, we had built up $2.6 million in receivables for Medicare claims that we had submitted in 2023 and the first half of 2024. This represents about half our balance of accounts receivable at the end of the second quarter. Based on our experience, we've learned that the Medicare administrative contractors require significant lead times to set up and begin initial claims payments, especially for entirely new products like the ReWalk. As a consequence, at the end of the second quarter, we had received a very small amount of payments for Medicare claims. The good news is, since the end of the second quarter, the pace of payments from the MACs has accelerated, and we have received over $600,000 against those receivables during the third quarter so far. We expect these catch-up payments to continue as the MACs work through the backlog of claims and that a significant majority of these payments will be received by us by the end of the year. Also important, since the payment mechanism has been established, future Medicare claims should be paid on a more typical 30- to 45-day cycle from the date that the claim is approved. Both of these factors have positive implications for our second half cash flows as the excess receivables are collected. Second, inventory. During the second quarter, inventory increased by $1.1 million due to two factors: first, in light of the continuing conflict in Israel, we are in the process of building an additional 25 ReWalk systems that we will have on hand in the U.S. in case there are any temporary disruptions in our Israel-based supply chain; second, with the filing of our 510(k) application for the ReWalk 7, we have begun procuring material for the inventory build in advance of the commercial launch, which will follow the FDA clearance. Over time, inventory levels will normalize as the inventory is sold and we convert this to cash. As Larry discussed earlier, we continue to expect full year 2024 revenue of between $28 million to $32 million. The third and fourth quarter revenues should show sequential growth from the second quarter. With the higher revenue, we expect continued margin expansion with the adjusted gross margin reaching approximately 50% by the fourth quarter. Operating expenses should continue to decline slightly over the next two quarters. The combination of these factors should reduce our non-GAAP operating loss by almost half by the fourth quarter, which will, combined with the collection of that Medicare receivables, translate to much lower quarterly cash burn. With that, I'd like to turn the call back to Larry for further remarks.

Larry Jasinski, CEO

Thank you, Mike. I'd now like to provide more detail on our market development and financial goals that I have laid out for the year in our Q1 call. Our stated goals were: number one, execution with sales; number two, organizational implementation of infrastructure to support Medicare claims submission to successfully penetrate this new emerging market; number three, market development in terms of filling the funnel with appropriate potential users of ReWalk system; number four, managing the reduction in our operating loss Q-over-Q to demonstrate a path to breakeven operations; and number five, launch of the new AlterG product in about midyear and preparation for the launch of the latest generation of the ReWalk post-FDA clearance. Let me expand on each of these five objectives for the year. First, sales, a record ReWalk quarter and another one on the horizon. Demand is building from our digital communication programs. The education occurring with physicians via our field-based team and the spinal cord injury centers that are beginning to implement exoskeleton supply programs based on our support program. We have presented our supplier program to over 50 centers so far in 2024, and our target for the year is to increase our placements to 100 or more systems. Second, capacity to implement. The Medicare requirements are extraordinarily complex and require extensive infrastructure with skills to process volume and get paid. We have supported our active spinal cord injury centers in multiple ways. They include: a dedicated ReWalk clinical screening group to properly qualify ReWalk users; next, as patients are qualified, we provide ReWalk trial systems with our direct physical therapists to determine whether a user is fully ready for delivery of a personal system; if successful, we then mobilize our reimbursement team to guide the process of completing the comprehensive Medicare submissions. During training in the clinic, we provide support as needed. And once ReWalk goes home with our system, we have a full service warranty and service team for the user. Third objective, market development. Identifying and educating the correct potential users, expansion of the MD referral base with our feet on the ground, creation of practice guidelines with medical societies, broadening product labeling, and establishing payment policies in multiple payer systems are the key pillars of our market development strategy during 2024 and 2025. We understand these requirements and have the team to build a long-term business. We are reporting these activities in summary fashion as we progress. Adoption of life-changing and disruptive technologies takes time and focused development efforts. In simplest terms, we must fill the funnel and will present metrics for the market to measure the progress as they mature. Fourth, reducing our operating loss. Top-line growth for 2024 is trending to expectations. The major thrust on efficiency is occurring from actions we initiated in 2023 and that are in process throughout 2024. We will identify the areas of cost reduction as they occur. We continue to forecast a 2024 loss in the low double-digit millions and operating at breakeven on current cash by 2026. The revenue growth slope and the expense reduction levels provide some risks that we must manage in the process. And our fifth objective, new product launches. Our new anti-gravity product was successfully completed with the launch of the new NEO anti-gravity model on June 25 at the National Athletic Trainers' Association event. This design has features and pricing specifically designed to address the needs of smaller clinics. Also in June, we submitted our FDA 510(k) for the seventh generation of the ReWalk design as we had planned. Each of these innovative designs will impact our sales and our operating results. Our leadership of our markets is an advantage of being first and in having the most extensive base of field experience. Our demonstrated results in these first three months since being placed in the federal fee schedule are very encouraging. While we focus on short-term measurements today, it is now time to open the door to the potential magnitude of payment coverage that has started with Medicare and the long-term vision of building upon it with all payers. It is time to envision a market of 1,000 systems a year with proper market development and investment. The potential benefits of exoskeleton utilization can now be realized on a wide scale to help people walk again and should be highly valued. I opened with our belief that we have proven the first steps in execution. We are on the right road, and we have the team in place to execute this. There is every reason to be optimistic about our progress. Thank you all for your time today. And operator, I'd like to open it up to questions, please.

Operator, Operator

Our first question comes from RK with H.C. Wainwright. Please go ahead.

Swayampakula Ramakanth, Analyst

Thank you. Good morning, Larry and Mike. Congratulations on a very positive quarter. So, let's start with the receivables. Mike, you said that after closing the second quarter, you did receive part of the receivables, about $600,000 has been recognized. And based on your conversations or your dealings with the CMS, how long do you think it will take for normalization in terms of time? And it looks like there's another $2 million worth of receivables left. Do you think most of it would come through in the third and fourth quarters, or some of that could spill into '25?

Mike Lawless, CFO

Hi, RK. Good morning. That's a good question. We have limited visibility to that, but our expectation is that there should be the majority that gets paid during the calendar year 2024. So through Q3 and Q4.

Swayampakula Ramakanth, Analyst

Okay. And then, on the AlterG business, it's nice to see that growth of almost $1 million in the third quarter compared to the previous quarter. How much of that AlterG is pent-up business because of the change of ownership? And how much of it is organic? And how should we think about sustenance of that growth from here onward?

Larry Jasinski, CEO

RK, it's Larry. I'll answer this one. This is really all organic growth. We have begun to build with the team we had in place. Mike noted what we have seen in our backlog that we've gone from the mid-60s to over 100 in our backlog, and this is from our field team knocking on doors and doing their job.

Swayampakula Ramakanth, Analyst

Perfect. And my last question is on regarding Germany. I would like to understand how business is progressing in Germany since the court case settlement that you received last year. Is that a slow growth business? Or how are the insurers responding to those decisions?

Larry Jasinski, CEO

Germany is having a good year. It's the best way I can measure it, including Barmer, who is in the court case, who has processed a good number of cases. So, we're progressing equally well, frankly, in both Germany and the United States. The United States' numbers are larger just because of the size of our insurance group and size of our country, but we are seeing growth in both markets that we're quite happy about.

Swayampakula Ramakanth, Analyst

Thank you. Thanks for taking my questions.

Operator, Operator

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

Ben Haynor, Analyst

Good day, gentlemen. Thanks for taking the questions. First off for me, just on gross margin, it was quite a bit ahead of where we were looking at. It doesn't sound like there was a lot of accounts receivable from Medicare patients that came through during the quarter where the COGS would have been realized in the previous quarter revenue in this quarter. Was there any kind of one-time impact on anything there, or is this just straight up improvement in gross margin sequentially?

Mike Lawless, CFO

No. Hi, Ben. How are you? Good morning. This is Mike. No, that's a good question. There were no one-time items, nothing unusual in the quarter. I would say that part of that is indicative of the higher volumes we were generating on the AlterG side. We have a factory in California where we manufacture, and we were able to leverage all of those production costs much more effectively with the top-line that we generated in the second quarter relative to what we did in the first quarter.

Ben Haynor, Analyst

Okay. That's helpful. Makes sense. So, just generally speaking, we probably should expect gross margin to continue to improve through the balance of the year as some of the Medicare payments begin flowing through and with the NEO launch and hopefully, more AlterG revenue?

Mike Lawless, CFO

That's correct. Yes. As I mentioned, by Q4, we expect our gross margins to reach 50%.

Ben Haynor, Analyst

Okay. Great. And then, on the R&D expenses, what should we expect there now that you've submitted the seventh generation version and launched NEO?

Mike Lawless, CFO

I expect that they will remain roughly the same or possibly decrease a bit. There is still ongoing activity occurring, so I anticipate that it will be somewhat flat or slightly down over the next couple of quarters compared to the levels in Q2.

Ben Haynor, Analyst

Okay. Got it. That's helpful. And just curious, any more color you can kind of share on the reaction to NEO in the early days here?

Larry Jasinski, CEO

Well, we launched it on June 25. So, you got about six weeks. We sold the model right on the floor at the trade show. We took that as a very good reaction. It is resonating as intended, at least in the early results.

Ben Haynor, Analyst

Okay, could you please remind us about the enhancements for the seventh generation? Are these enhancements related to cost of goods sold or product improvements?

Larry Jasinski, CEO

This is a very user-based improved design. We've got the experience with hundreds of users of what they'd like and not like and wanted to see the device offer. So, what we've done is add in features that came from our customers, and I'll give you a few examples. One is having multiple speeds. So, if you're walking down a busy street, and you've got to go slower because the people in front of you aren't going fast enough, you could slow your ReWalk down. We've done other fundamental things to bring more up-to-date off-the-shelf battery systems that you can use now to power the system, as opposed to the custom batteries that we had before. We've added a lot of data components and connectivity to the system through a smartwatch, and that is really important, we believe, for the users to communicate for us to know about utilization. Those are just examples of some of the features. Our customers told us what they liked; we did it. That's basically what the ReWalk 7 is.

Ben Haynor, Analyst

Okay. Great. We're looking forward to that. That's all I have for now, gentlemen. Thank you very much.

Larry Jasinski, CEO

Thank you, Ben.

Operator, Operator

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

Larry Jasinski, CEO

Well, first, I appreciate everyone's attendance today, and I'd encourage you to come to us if you have other questions about the business. I closed the scripted part of the session by talking about the magnitude of this market. Now that we see real execution and we've achieved it, and it's growing, thinking about the ultimate size of this market is something that I would encourage all of us to think about because we've talked about it in tens and twenties. It is not unreasonable, given the total addressable market, for this to be 1,000 systems a year. Now that takes time to build. It's not easily done, but it's the value that the vision of our company with our founders started with: the widespread ability for people to walk again. And that's what this industry now has in front of it, proven by the success we've had in this first 90 days after gaining United States coverage with Medicare. So thank you, everybody, for your time today, and we look forward to speaking to you in the future.

Operator, Operator

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