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spk00: Hello, and welcome to the Q2 2023 Rewalk Robotics Limited Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a 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 will press star then one on your touchtone phone. To withdraw your question, please press star then two. Please note, today's event is being recorded. I now turn the conference over to Mike Wallace, Chief Financial Officer. Please go ahead.
spk02: Thank you, Keith. Good morning and welcome to Rewalk Robotics' second quarter 2023 earnings call. I'm Mike Wallace, Rewalk Robotics' chief financial officer, and with me on today's call is Larry Jasinski, Rewalk's chief executive officer. Earlier this morning, Rewalk issued a press release detailing financial results for the three and six months ended June 30, 2023. The press release and a webcast of this call can be accessed through the investor relations section of the Rewalk website at rewalk.com. Before we get started, I would like to remind everyone that any statements made on today's 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 Rewalk Management as of today. It involved risks and uncertainties, including those noted in our press release and REWOC's 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. REWOC 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 the company's website. For the benefit of anyone who's going to be listening to the replay or the archived webcast, this call was held and recorded on August 11, 2023. Since that date, Rewalk 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 Rewalk's CEO, Larry Jasinski. Thanks, Mike.
spk03: Welcome, everyone, and thank you for joining us today. Q2, along with subsequent events, was an excellent period for the company, and specifically in regard to the milestones we have been pursuing. In the last few weeks, we have hosted two public calls on the subject of the proposed Medicare rule that would formally define a benefit category for personal exoskeletons and a call on our pending acquisition of Alter-G. In parallel, we achieved revenue guidance for the quarter and submitted 11 new Medicare claims in Q2 exceeding our original goal. We believe these factors will continue to drive our business, allowing us to conserve capital in 2024 and 2025 and achieve profitability in 2026, relying solely on current cash reserves. Though our call today is to report on financial performance and provide a business update on the second quarter of 2023, I'd be remiss if I didn't start today's call revisiting our exciting and transformative acquisition of Alter-G that was announced on August 8th, with closing planned for later today. Alter-G is a leader in transformative technology that empowers people to recover mobility, improve wellness, and enhance physical performance. The Differential Air Pressure, or DAP, technology serves to reduce the effects of gravity allow movement in new ways with finely calibrated support and reduced pain. We believe the technology is unique, well-accepted with placement in over 4,000 clinics around the world, and has excellent growth potential to expand in a segment that has 40,000 U.S. clinics which can benefit from DAP technology. Rewalk's stated strategy has for some time been and continues to be to add adjacent and creative technologies via acquisition and organic development. Now, what we're seeking to do is to increase our scale, to build our strategic position in the clinic, to expand our organizational skills, and add depth for commercialization. We believe the acquisition of Alter-G with its patented NASA-derived DAP anti-gravity system for use in physical and neurological rehabilitation is a prime example of of executing on this strategy. We believe the Altergy acquisition leverages a shared market presence and creates efficiencies across all product lines. Further, we believe combining Altergy's strong track record, assets, and skilled team with Rewalk's innovative leadership in exoskeleton technology and established infrastructure will create a formidable development, production, and commercial enterprise poised to maximize the opportunity across the product portfolio and drive towards profitability. The addition of Charles Ramsburg as our Chief Sales Officer is the right step in developing a larger organization that is highly capable of capital equipment sales and placement of systems to those that come through the clinics to be trained on home systems. Clearly you can tell we are very excited about this event and eager to update investors over the months ahead as we build up and realize benefit from our joint operations. With that recap complete, I will now provide a quick summary of figures from Q2. Sales in Q2 were 1.3 million in line with prior financial guidance. For 2023, our active case exoskeleton submissions are expected to convert to achieve year-over-year growth driven over the second half of 2023. This is spread over the VA, Germany, and the U.S. The revenue contribution for the addition of the Altergy anti-gravity systems is also expected to be added once that transaction closes. Expenses were also in line with internal expectations, and excluding the expenses related to acquisition activity declined by $300,000 from Q2. Mike will address this further in the financial results section. Our efforts with the Center for Medicare and Medicare Services, CMS, to expand the access of exoskeletons to Medicare beneficiaries is a key element of our strategic path and will be, we believe, a defining point for the exoskeleton industry. The process with the proposed rule to codify the definition of brace to include personal exoskeletons is in a public comment period until August the 29th. final rule will be developed from the base proposal and the comments provided. This final rule is expected to be issued in the November-December cycle and become effective January 1, 2024. Parallel considerations on price should occur in the HCPCS process with a proposed price in late 2023 that may have a public comment period to follow. Finalization may occur in early 2024. After several years of effort, a code, a benefit category, and a price point are the foundation to facilitating Medicare beneficiaries' access to exoskeletons. Rework is highly supportive of the CMS proposed rule, and we are working extensively to support this process. The placing of 11 CMS beneficiary claims during Q2 and continuing submissions during Q3 and Q4 supports our target to place at least 35 submissions during 2023. Creating a repeatable process to secure payment for the Rewalk device for Medicare beneficiaries is an essential priority. The Medicare SCI population is the largest population segment of individuals who could benefit from this technology and therefore our single largest potential market segment in our single largest potential market, the United States. I am confident that our efforts will positively shape the industry in the long term. I'd now like to turn the call over to Mike for review of financial details. Mike?
spk02: Thanks, Larry. Rewalk Robotics reported revenue of $1.3 million in the second quarter of 2023, down $0.2 million, or 15%, compared to $1.6 million in the second quarter of 2022. This was in line with our guidance from the prior quarter's earnings call. For the six months ended June 30, we reported revenue of $2.6 million compared to $2.4 million for the six months ended June 30, 2022, up $0.2 million, or 8%. The decrease in revenue as compared to Q2 2022 for the second quarter was a result of continued exoskeleton sales performance in Germany, while the U.S. exoskeleton revenue was down slightly from the prior year's quarter. Our distributed product line, the MyoCycle FES Training Cycles, had another strong quarter with revenue of over $500,000, up 60% from Q2 2022. The success of our sales effort around MyoCycles is a validation of our strategy to build a portfolio of complementary products that we can provide to our customers. Turning to our pipeline metrics within the current market for the Rewalk product line, which includes individuals covered by the Veterans Administration and Workers' Compensation Insurance in the U.S. and by private insurance in Germany. The current pipeline of active rentals consists of 22 cases, up four from last quarter, which is broken down with 18 in Germany and four VA rentals. Our overall number of cases and process is 70, with 56 in Germany and four in the U.S., As a reminder, these pipeline figures do not include cases that would be eligible for Medicare reimbursement. If our progress with CMS successfully results in the establishment of an acceptable reimbursement mechanism and payment rate, then we can supplement the pipeline totals with our list of already identified Medicare eligible patients. Moving to gross profit, in Q2 2023, our gross profit was $0.6 million, or 43.1% of revenue, down 4.4 percentage points, as compared to $0.7 million or 47.5% of revenue in Q2 2022. This decrease in gross margin was primarily driven by lower exoskeleton volumes. Operating expenses in Q2 2023 were $5.7 million, up $0.6 million, or 12%, compared to $5.1 million in Q2 2022. Within the functions, R&D spending decreased $0.1 million, or 15%, primarily due to lower spending on subcontractors and consultants due to the completion of the STAIRS project in the U.S. and the lower spend on the REWOC 7 projects since we were in the final stages towards FDA submission. Salary and marketing expenses increased 0.2 million, or 7%, primarily due to higher consulting fees associated with CMS reimbursement-related activity and trade show expenses. General and administration expenses were 0.6 million, excuse me, increased 0.6 million, or 33%, due to higher professional services fees related to acquisition activity. Excluding the M&A transaction-related expenses, G&A expenses would have been 1.5 million, down 0.3 million, or 16%. The M&A transaction-related expenses consisted of legal, accounting, and investment banking fees that were incurred during Q2 2023. We will incur additional transaction fees in Q3 for the due diligence and transaction processing work that continued into the current quarter. Our operating loss for the second quarter of 2023 was $5.2 million compared to an operating loss of $4.4 million in the second quarter of 2022. Excluding the M&A transaction related expenses, the operating loss was $4.3 million or a $0.1 million improvement versus Q2 2022. I'd like to point out that we generated $558,000 of financial income in Q2. The favorable increase in income is a result of a more aggressive yet prudent cash management policies that resulted in higher interest income contribution from our cash balance. We ended the quarter with $58.2 million in cash and equivalents and no debt. Our operating cash usage in Q2 was $3.5 million, and for the first half of 2023, it was $8.7 million. During Q2, we repurchased approximately 359,000 Rewalk ordinary shares and spent $220,000 in cash for these repurchases. You may recall in February, the Israeli court approved a second six-month period for us to repurchase shares under our repurchase program. This six-month authorization ended on August 9th. We will evaluate the use of our capital for share repurchases versus other investments. If we decide that share repurchase is the best use of our capital, then we will seek another six-month extension. As we announced a few days ago, REWALK entered into an agreement to acquire Alter-G for $19 million, adjusted for transaction expenses, working capital, indebtedness, and cash on hand, with the potential for two earn-out payments over the next two years based on the year-over-year growth that is achieved for the Alter-G business. This transaction is expected to close later today. Accordingly, REWALK's financial results for Q3 would include the financial performance of Alter-G starting from August 11th through the end of the quarter. With that, I'd like to turn the call back to Larry for further remarks. Thank you, Mike.
spk03: We laid out our goals for 2023 at the start of the year, and I'll provide progress on each of them after each quarter. To restate the goals, to achieve sales growth via our workers' compensation and VA activity, along with adding more contracted insurers in Germany, and two, to expand our portfolio products through distribution agreements or product line acquisitions, And third, to leverage these activities to move towards break-even profitable operations with current capital. We have made substantial progress on all three objectives. For 2023 revenue, we anticipate year-over-year sales growth with our existing lines as Germany has increased their leads and increased their submissions in the first half of the year to support growth in the second half. And as the VA has opened up more facilities to candidate referrals and exoskeleton training, we expect to approximately double the number of exoskeleton placements from five to 10 or more veterans year over year. We see potential upside with the CMS MAC case submissions if they are paid in part in 2023. At the closing of AlterG, we would also add four and a half months of anti-gravity systems sales with the AlterG lines to add to the 2023 results. For our objective of growing our portfolio, the acquisition of AlterG will add three new complementary products in the VIA, FIT, and PRO anti-gravity systems. These broadly used and well-accepted products grew at a CAGR of 10% for 10 years pre-COVID, and can continue to expand penetration into clinics with current and upcoming new designs. For leveraging growth and expenses to reach breakeven on current capital, the progress with CMS is a key driver as we seek to advance from approximately 40 exoskeletons units per year to hundreds once available to Medicare beneficiaries. We believe that the parallel addition of an established, growing, and profitable line of DAP products with the AlterG programs systems will also drive a reduction in burn rate in 2024 and 2025 and lead to profitability with a workable cash balance if we execute on our goals. I also wish to thank our existing shareholder base and the new shareholders that have recently joined us for their commitment in supporting these life-changing technologies as we expand this business in 2023 and 2024. I look forward to providing further updates each quarter and through communication of each milestone as it is achieved. I would now like to answer any questions you may have.
spk00: Yes, thank you. At this time, we will begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, Please pick up your handset before pressing the keys. To withdraw your question, please press star and the two. At this time, we will pause momentarily to assemble the roster. And the first question comes from Swaibamkula Ramakath from HC Wainwright.
spk01: Thank you. This is RK from HC Wainwright. Good morning, Larry and Mike. Good morning. As you stated, when you get the brace category, if it gets awarded for exoskeletons, including Rewalk, in the November timeframe, in terms of the HCPCS code, would that change the category of the HCPCS code? And what sort of a benefit is expected out of that?
spk03: Well, there are three components. There's a code in which they apply the product, and that is the K107-1007 code that exists. That does not change. That is a created code for exoskeletons that defines, in particular, the Rewalk product well. Once you have a code, it has to be applied to a benefit category in order to be paid for. And that has been our gap. So what's going to come out of the rulemaking process is a defined benefit category, which is essentially exoskeletons within an existing category of braces. A challenge had been there was nowhere to put us because there was nothing even remotely like what we did. The product is so innovative and different, it didn't fit in the CMS system. And that was the frustration that why we didn't have a category. By changing the definition with this rulemaking into a new category or a newly defined category into an existing category, it will now be able to be paid for. So it'll go under that code. It now has a defined benefit category in the brace if the rulemaking stays on track. And then the price, the HCPCS process is the establishing the final price. So there's three stages to us here to work through. First one's succeeded. Second one is defined now by CMS and going through comments. And the pricing one is the HCPCS discussions where we believe they will propose a price here at the November HCPCS meeting. And it may or may not go through a public comment period. If it goes through a public comment period of 60 days, they would then issue a final price after. So we will have a benefit category, we believe, in this calendar year, November cycle, we will have a pricing proposed and issued somewhere between the end of this year and the end of first quarter next year is probably the best way I can definitively say it, but the timelines are up to CMS and not up to us, so that's why I'm being a little cautious on them. Was that a better explanation, okay?
spk01: Yeah, yeah, that's good. So you can imagine where I'm heading this question to. I'm just trying to understand once in November, once you are given the brace category, do you still need to wait for the reimbursement dollar to be identified before – before reimbursement starts, or as soon as you get the category, you know, it can get reimbursed?
spk03: Well, you were supposed to be able to get paid once you have a benefit category, but we need a price. So our challenge is CMS will have to decide what price they will use as they process it through the MACs. So one of the reasons we have filed the 11 claims in Q2 and put in 35 or more this year is they've got all these pending ones that will have met all the definitions, and they'll either use the proposed price as an interim pricing or some other price that they can establish in theory until there is a final approved price. But once you have a benefit category, we've then met all requirements for it to be paid for. They just didn't say how much yet. That wasn't the clearest answer, and that's exactly the way I understand it.
spk01: I get the answer. So this leads me to the next question. So the 11 submissions that you did in Q2, and they expect to get to your 35 by the end of this year. Is it really difficult for us to figure out what the lead time will be because they still haven't identified or are in the process of identifying a reimbursement amount? Or is there any regulation that once they take in the reimbursement, once you submit, there's an X amount of time by when CMS has to
spk03: reimburse? There are timelines that they should be following, and it will become repeatable. Our conservative approach has been, even though we will have placed at least 35 products in this calendar year at the moment, we're still not planning on any revenue for them until early next year or sometime. So we have a fairly large base of delivered products in the hands of people being trained that will get paid for at some point, but we didn't put it in this calendar year. Typically, once the process is defined, it is not a long process. The submission part and training takes some time, but the actual cycle for payment is typically 30 to 60 days. The government is relatively good once they have a process in place. So answering, the timeline should not be extremely long once the process is established, which is where we think we're going to be by Q1 next year, based on all the effort that has gone on with CMS and the feedback we've gotten.
spk01: Perfect, perfect. So now switching gears to the acquisition. Now we know that our R2G transaction potentially is going to complete by the end of today. So in terms of, I know you stated in your prepared remarks that you could expect about four months worth of revenues from R2G. Are you folks ready to identify a dollar amount or is it too early to talk about what the upside is going to be on the revenue side. And then in terms of synergies, can you give us some sort of high-level commentary as to what sort of synergies we could expect?
spk03: And, Mike, I'll let you start. You can give some of the history on revenue and what our expectations are, how we think it will develop. Yeah, sure.
spk02: Yeah, okay. So the Ultra-G business is, you know, for 2022 was a $20 million revenue business. It's growing now. We would expect, I think for the current quarter, for Q3, since it's a partial quarter, we prefer not to provide revenue guidance, but it's roughly half a quarter's worth of revenue from them. Obviously, since it closes as we expect on August 11th today. On a going forward basis, when we have the benefit of putting the two management teams together and doing quarterly forecasts as a team, I think we will start to consider and think about how we want to be able to provide guidance to the street. The benefit of this transaction is that we'll have a little bit more scale now, more predictability, and we'll have more material to be able to forecast our coming performance. I think we can look to more definition around what our guidance could be in future quarters.
spk03: And I'll add a comment more from the way we're managing this. There's been extensive effort in the pre-closing integration process. The sales team that has been predictable with Alter-G is in place and unchanged from the After it closes this afternoon until December 31st, it is the exact same group that has been delivering their numbers for years. So it's completely unchanged. Next year we will combine the sales forces and have a bigger one and go through some training. So that will get even more reps that can sell it. But having the same team in place makes us feel pretty good that they will be continuous in their revenue results.
spk01: Great. And then also with this acquisition because you're going to get additional points of contact especially in the clinic. So what are your thoughts about relaunching the clinic unit of Rewalk as well as any commentary on cross-selling of some of the products that you sell in the clinic point of sale?
spk03: I think Mike and I can both give comments that also on the synergy for both the growth and expense. But from a strategic end, going into the clinics with a much deeper and larger team that has established relationships is going to benefit us most easily with the MyoCycle product lines because it's a very well-established and designed clinic product. With the Rewalk product line, the primary area we see this really helping us is more of the clinician level Because if we have CMS, we need these clinicians to write prescriptions for the right patients. And this gives us a base to our synergistic approach is more towards selling personal units using those relationships than anything else. So those are the strategic ways we're approaching it. Relative to the REWAL clinic model, it is not a large expectation here because most of the training is done in the unit that they're going to eventually take home. If CMS is playing for this on a lump sum, the clinic will use the product that fits that specific patient. So we believe that will work well for it.
spk01: Perfect. Thank you. Thank you for taking all my questions.
spk03: Okay. Well, there's two I'll add in. Restore also is a product that we've not really been able to push in the clinic, so we will reignite some effort around that. And you would ask a little bit on the synergy. I gave you the revenue strategic synergy. Mike, do you want to comment a little on the expense side?
spk02: Yeah. So, yeah. So, on the expense side, as you can imagine, there's some duplicate vendor and subscription costs and things like that, which are, you know, we're going to be working through and, you know, able to eliminate relatively quickly. There's also the opportunity as we grow that both businesses and their business plans had the need for future hires as we grew to support, you know, more of the resources and the larger businesses that we would have. And because of the talent we're bringing together, there's the opportunity for us to avoid those new hires because we're gaining some of those talents through the combination with our peer companies. So, Over time, we expect to see annualized savings of about a million dollars from this transaction, resulting from the combination of those two factors. But I would say that those are going to be things that phase in over time, and so I would expect it would, you know, within a year's time, we'll be experiencing those million-dollar savings.
spk01: Perfect. Perfect. Thank you. Thank you for taking all my questions. Thanks.
spk00: Thank you, Eric. Thank you. And once again, please press star then one if you would like to ask a question. All right, if there is nothing else at the present time, I would like to return the floor to management for any closing comments.
spk03: Thank you, Keith, and thank you, everybody, for joining us today. Rewalk today is a bigger, better company that is better positioned to grow, bigger and better because it's a combination of Rewalk and AlterG That simple addition is there. But also, the position to grow is because of the progress with CMS. As we go here into Q4, our extreme high level of focus will be on integration. We put an extensive amount of planning and detailed time on every step of the integration process pre-closing this. We are very well prepared. And the next few months will be a very significant period to effectively make this work by doing the integration process correctly. And we understand the importance of that. This is how you make these things work and work well. And we have a team that's experienced in it. and we also have outside expertise that has helped us make sure we are getting every detail right. So that is a very important measurement for us and we're laser focused on it. Second, and we're just as focused on this, is the CMS process is still in process. So we are highly active in working to provide support in the comment period, obviously with our own positive comments, because we believe CMS is going the right way, in educating political leaders, in educating the societies that would support this, and encouraging them to also provide comment. We are also working to provide support on pricing and why the pricing that we have established is the best for the industry, the best for the patient, the best for the beneficiary, and reasonably established with what we already have with the VA and others. So there's an extensive amount of work in this quarter, which we're really excited about and will be able to report on as we get to our next earnings call. Thank you again for your time today.
spk00: Thank you. As mentioned, this concludes the question and answer session and the call. Thank you so much for attending today's presentation, and you may now disconnect your lines.
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