ReWalk Robotics Ltd.

Welcome to the Q4 2021 Rewalk Robotics Earnings Conference Call. My name is Vanessa, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct our question and answer session. To queue up with your question, you can press star, then 1 on your touchtone phone, and these instructions will be repeated for you. I will now turn the call over to your host, Ori Ghan.

Thank you, Vanessa. Good morning and welcome to Rework Robotics' fourth quarter 2021 earnings call. This is Oregon Rework Chief Financial Officer and with me on today's call is Larry Jasinski, our Chief Executive Officer. Today, the company issued a press release detailing financial results for the three and 12 months ended December 31st, 2021. This press release and a webcast of this call can be accessed through the investor relations section of the Rework website at www.rework.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, focus, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Rework Management as of today and involve risks and uncertainties. including those noted in our press release and reworks filing 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. Reworks specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-gap reconciliations, on our corporate website at rewalk.com. A telephone replay of the call will be available shortly after completion of this call. You will find the dialing information in today's press release. The archived webcast will be available on the company's website at rewalk.com. For the benefit of those who may be listening to the replay or the archived webcast, this call was held and recorded on February 24, 2022. Since then, Rewalk may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC findings. And with that, I'll turn the call over to Rewalk CEO, Larry Jasinski. Larry?

Thank you, Ori. Rewalk completed 2021 in a positive position to achieve our vision of creating a meaningful and sustainable market for personal use of robotic technologies to change people's lives. The key measurements for the year are progress in creating systemic reimbursement payment pathways to build a business, technical developments that can expand our markets and allow more effective market penetration under coverage programs achieved, and a financial position that supports achieving our goals. During a year when the pandemic continued longer than expected and the significant spike in the fourth quarter with the Omnicon variant, The company grew revenue for the year ended December 31st, 2021 to 5.97 million, a 36% increase year over year. We had 1.24 million in Q4 sales, which was a 2% increase over the prior year quarter. During 2021, the COVID-19 pandemic continued to impact our sales activities. Three key factors were one, Reduction in incoming leads over much of 2021 as trade shows and in-person demonstrations were very limited by COVID-19 restrictions. Two, our inability to train patients as many clinics remain closed, which prevented the six months plus cycle of moving patients through the system for Q4 conversion due to the ongoing pandemic. And three, further limitation of conversion of the trainings that were achieved to date due to the Omicron variant spike in Q4. These levels of revenues are not sufficient for a sustainable business. Significant expansion of market penetration and revenue is reliant on success with reimbursement and our ability to implement this in the marketplace. I'd like to review three categories of focus that we believe will support this future. our continued progress in establishing reimbursement payment programs. Second, the technical developments with respect to our products that we believe will support growth. Third, developing and putting in place structures with respect to training, service, reimbursement assistance, and sales coverage to grow effectively. To add detail to these three categories, starting with reimbursement, Our results will be driven by German definitions through the legal process and through the completion of benefit category pricing and coverage by CMS, the Center for Medicaid and Medicaid Services. In Germany, the Federal Social Court, the highest court in the country to define social programs, continues to progress on a court case that will define for all insurers whether direct compensation for a spinal cord injury is a requirement in the German system. The case initiated in 2017 and has progressed to this final point of determination over the past five years. The court does not provide specific information on the timing for ruling on an accepted case. But in the publicly published court docket on January 7, 2022, Rewalk is the third case on the docket out of 24 listed. While we have no guidance in the sequence the court will hear or address cases, we have been advised that a Q1 determination is a reasonable expectation. In the United States for CMS, we significantly expanded our resources and talents to support completion of coverage based on the new code we applied for and achieved in 2020. We have focused on expanding the evidence documentation providing information and engaging with CMS regarding the decision on a benefit category and for pricing, and in preparing our initial cases for submission to CMS. The current dossier is being enhanced to articulate clinical, economic, and humanistic value in relevant stakeholders' language. On the evidence-based documentation, we have expanded the materials to meet the standards for all submissions, and are providing new scientific support for the economic value and in modeling for payers. On December 21st, 2021, CMS issued a final rule on DEMPOS. That's durable medical equipment, prosthetics, orthotics, and supplies. This rule provides methodologies for benefit categories and payment determinations for new items. This directly applies to exoskeletons, and our code that was created in late 2020. This final rule provides us a clear path forward with respect to CMS. We anticipate our benefit category and pricing will be addressed at CMS sessions occurring mid-year with conclusions on or before their fall sessions. We intend to process our first Medicare, Medicaid cases in 2022 and expect a coverage path they will be defined by year end or early 2023 for patients to pursue exoskeletons. We further expect that this progress with CMS will allow our expansion to the private sector afterwards. A reliable, systematic method to identify the proper patients and supply those that meet all the requirements to achieve a way to walk once again is our end goal. Moving now to technical developments and achievements to support market growth. In 2021, we have worked on features for the spinal cord injury designs which will expand the ability to use the system in more places in the United States and have focused on meaningful technological improvements for easier operation and expansion of the data provided to users and all stakeholders on a global basis. We anticipate two FDA submissions in 2022 for the different design improvements we have developed. Rewalk is the most used personal exoskeleton in the world and proceeding to a seventh generation design. We are also taking early research for an eighth generation that we believe will continue to make the system easier to use. Now, regarding infrastructure for the implementation of coverage, we are focused on ensuring that we have the training, service, reimbursement assistance, and sales coverage to achieve a market development and growth. We have learned a great deal from our success in Germany in how to expand and support our customers. This has provided a model for our US plans as reimbursement is determined. In addition to maintaining and expanding the US and German teams, we have added a contract with a company called Robotics Technology in the UK, where we have transferred one of our employees and they are providing the full infrastructure needed to support expansion in the UK. As a company, our capital position is suitable to achieve these goals and allow the company to move from an establishment phase to a growth phase. It has taken longer and has been harder than expected, but the stage is set as a pivotal year, which is built on a long period of gaining understanding of the potential of these technologies and in having systems and support from all stakeholders to move forward. I'd like to ask Ori to cover the specifics of your end financials and our overall financial position.

Thanks, Larry. We will report the total revenues for fiscal year 2021 of $6 million compared to $4.3 million in 2020, which represents 36% year-over-year growth. Our 2021 fall quarter revenues remain flat with $1.2 million compared to the prior year quarter. Now let's look at the elements that drove the growth in 2021 in some more detail. First, Personal 6.0 sales have increased by 14 systems with a higher average selling price, resulting in a total of $5.3 million compared to $4.1 million last year. The increase in volume was shown in both the U.S., which included our multi-unit order to an academic center in the third quarter, and in Germany, where we had five more units sold this year. The average selling price was positively affected by the euro-dollar exchange rate and change in sales mix. Second, Distributed products' performance has increased to $446,000 compared to $86,000 in the previous year. This increase is primarily with our MyoLyn FAS product line, as we sold 20 personal systems and 9 rehab systems, compared to 6 and 1 respectively last year. We have also placed our first two MediTouch kits within two clinics in Q4 2021. Third, Our restore results remain generally flat with seven units sold each year and a total of $199,000 in revenues this year compared to $160,000 in 2020. Now let's look at our insurance performance. This quarter, we had a total of seven new insurance decisions to place a device for a new rental or a direct purchase, including one from the VA and five conversions of previously rented devices. Our current pipeline of active rentals consists of 15 cases, representing a total revenue potential of $1.5 million, and our overall pending insurance cases is currently at 71, with 56 of them in Germany and 15 in the U.S. Turning to our gross margin. In the fall quarter of 2021, our gross margin was 27% compared to 33% in the buy-day quarter. This decrease was mainly due to reduction in our average selling price due to change in sales mix this quarter compared to the last one. Our fiscal year 2021 margin was 49% compared to 50% in the previous year. This year, we have written off some of our restored inventory parts as we had lower sales than expected due to COVID restrictions that have not allowed us to price and demo the device properly. We have also seen increased service costs. We anticipate margins will return to similar levels for the full year in 2022. As we look into our operating expenses, our 2021 fourth quarter OPEX were $4.2 million compared to $3.2 million in the prior year quarter. This increase is mainly attributed to our SG&A as we had higher labor and sales-related expenses, as well as an offsetting PPP loan that was forgiven in the previous year. The lower R&D that offset this increase is mainly due to lower employee and employee-related expenses as well as reduced professional service. Our full year OPEX landed in $15.6 million compared to $14.2 million in the previous year. Same as we have seen in the fourth quarter, the main contributors to that change are higher SG&A offset with reduction in R&D employee and employee-related expenses. To recap the quarterly results, our net loss for the fourth quarter of 2021 was $3.9 million compared to a net loss of $3 million in the fourth quarter of 2020. Our non-GAAP net loss for the fourth quarter of 2021 was $3.6 million compared to $2.7 million in the fourth quarter of 2020. Our yearly net loss in 2021 was $12.7 million compared to $13 million in 2020 Our non-GAAP net loss was $11.6 million in 2021 compared to $11.9 million in the previous year. We ended the year with $88.3 million in cash, and our cash burn was $11.5 million compared to $12.6 million in the previous year. With that, I'd like to turn the call back to Larry for additional remarks. Larry?

Thank you, Rory. I'd like to complete the session today with three topics, organizational plans, a few key events that occurred in Q4 and early Q1, and then our 2022 goals. First, on the organization. My colleague, Ori Ghan, just completed his presentation and is a transitory one for him as he is moving to a different opportunity in the coming weeks. He has worked in our company as our controller and later moved to the CFO role. He has a very meaningful list of accomplishments. all during a period of challenges pursuing the building blocks of market development, operating a sufficient team to pursue our goals, controlling our spending, and then strengthening our financial position. He has had a major role in advancing our company and this industry. I thank him for his efforts and his results, and I wish him the best for the future. Looking forward, we have a very strong team in place through the management of our Director of Finance, Amal Gadar, who has been working with us for over two years, and his group in Israel, Germany, and the United States. They are all well-versed in our controls and reporting, as they are the team that has led us through the past few years in all financial aspects. During the transition period, we also have Ami Kraft, who is the CFO who took us public, continuing in his role as an executive vice president who has advised the management team over more than 10 years. He will be able to help during the period of transition. For a new CFO, we have a very active search underway through a highly skilled recruiting company that has great depth in recruiting public company CFOs with medical device experience in the United States. We will make announcements as the process concludes. Second, I wanted to provide a few events that have occurred that are meaningful to our business goals. Within the VA, they have been greatly limited over the last two years by the COVID restrictions, but have made recent progress with advancing a re-walker through the system under the Choice Program, which allows training at a local clinic under the guidelines of the VA. The VA is also supporting some veterans for training at local regional VA spoke centers. under the guidance of the national hub locations for patients that lack reasonable geographic access to a VA hub. This is exciting news for us. We've worked very hard to support expanded local VA training. Just to remind everyone, this program means there are currently over 100 Rewalk training sites that a veteran could provide access to a veteran that may widen use beyond the 24 VA hub sites. The VA co-op randomized trial publication has been significantly delayed with the pandemic, but in 2021, we've been able to conduct an extensive study of economic factors from use of an exoskeleton in the VA system. We have worked with the VA in examining their database, comparing cost to the healthcare system for injured individuals in the period before they walked to the period when they were walking in an exoskeleton. We anticipate we'll be able to publish this information in 2022. With our soft exosuit, our presentation, promotion, and clinical use of the Restore line has been greatly limited due to the lack of access caused by the pandemic. Where we have been able to implement, the effectiveness of the soft exosuit is being measured. In the UK, the initial clinical evaluation occurred within the NHS and under NICE guidelines. It had a successful trial conducted at two NHS trusts, and the satellite site will now be assigned. This satellite site will function as the hub for other NHS sites in the process of their store implementation within NHS rehabilitation clinics. With robotics technology as our newly established business partner in the UK, we'll be more successful in fulfilling the requirements for NHS procurement. In the United States, one of the largest national chains has completed their committee review process and has decided to schedule clinical demonstrations of the Restore soft exosuit as one of the new technologies in consideration. Once all the selected manufacturers complete their demos, the committee will determine which technology should be clinically evaluated in 2022. We anticipate this may be able to serve as a basis for a post-COVID relaunch later this year. As we gain defined, repeatable pathways for payment, our marketing focus is now more on development of significant referral centers that we believe will generate growing centers to attract and supply multiple patients, as well as coverage reimbursement allows them to move past the case at one time and a focus. We have had one of the first chains taking on this approach in northern Germany as they are preparing to add a rewalk and a restore to their offering as a business-building method for the centers. Now I'd like to highlight our key objectives for 2022. Number one, we expect revenue growth as COVID lessens, the German core case is defined and allows additional supply contracts, the VA reopens, and as we move our first CMS case forward. The timing of many of these are beyond our control and that limits our ability to provide further guidance at this time. Number two, we seek to add at least one additional commercial product line which we believe can further leverage our organizational structure, provide growth, and help achieve the pathway to profitability. This additional business acquisition plan has been an active M&A process and we have used outside expertise for strategy, analysis, and planning. Number three, advance Medicare category for determination, pricing, and coverage. Number four, submission of two 510Ks for improved rewalk designs to launch in 2022 and 2023. The timing to launch is dependent on the CE and FDA process and some supply chain considerations. And number five, controlled but increased investment of an additional $3 to $4 million in reimbursement, product development, market development and access, investor relations, and new business development. We will provide updates to each via press releases, quarterly earnings calls, and other appropriate communications. Well, the stage is set. This is a pivotal year for this company and this industry. We strongly believe we are on the right path and look forward to reporting on this throughout the year. Thank you very much for your time and interest today. I'd like to turn call over to questions at this stage. Vanessa, can you go ahead with the instructions, please?

Yes, sir. We will now begin our question and answer session. If you have a question, please press star then 1 on your touchtone phone. If you wish to be removed from the queue, you can press the pound sign or the hash key. If you're using a speaker phone, please pick up the handset first before you press the number. Once again, with your question, please press star, then 1. And I see we have our first question from Arthur He with HG Wainwright. Please go ahead. Your line is open.

Hi, Larry and Ari. This is Arthur for RK. First, congratulations on the strong finish for the year. I just want to follow up on the German federal court case. So I recall during the pre-remarks you mentioned the case was in the queue for the 2022 rulings. Could you tell us what gave you the confidence for your estimate for the decision by the end of the first quarter, if I recall correctly?

It is primarily based on the progress we've seen with the court. We have steadily moved up the list. And it is through the interaction we've had with our counsel. Very important case, I think, for the German social system and the courts. So we believe it will be addressed here in Q1 if COVID keeps the courts open. That has been one of our big limiters. But that is generally the guidance we've been given mostly by counsel.

Thanks for that. Could you remind us how many cases are pending for the German insurance?

I can speak about that, Larry. We have a total of 56, 5-6 cases within the insurance pipeline. Out of them we have 13 active rentals currently being trial trained into a conversion and remember we have a good conversion rate over 60% and it's getting even improved as we continue to qualify the process and the patient and the rest are basically in the reimbursement pipeline about half of the 56 are within what we call the legal stage, okay? And those will be the ones who will be more affected of a positive decision when it comes.

Oh, great. Thanks for that, Ori. So, Larry, I just want to pick your brain regarding the CMS decision. So, if I understand correctly, If things moving smoothly, we could expect a number for the reimbursement from the CMS by the early of 2023. Is that correct?

There are sessions that are held within CMS that they conduct in mid-year and in the fall. And we will also begin moving some cases forward. And those two events together, the cases that we will put in for payment, will help them set and finalize the category and the pricing. So they are all sort of working together, so there's multiple things moving. But we do believe we will have a conclusion in 2022. I see. A little bit of fear of COVID still after the two years we've just had. But if we can keep the business open and everybody's continuing to work, we should be okay this year. Gotcha.

So I guess for the follow-up, do you guys have started the competition with the private insurance payer or you prefer to wait for the discussion after the CMS to getting more engaged?

We do have some ongoing interaction with the private insurers at a lower level, but we believe that because many of the insurers also are overseeing parts of Medicare Advantage and things of that type, that this is a much more appropriate path after we have completed things with CMS to engage at a coverage and policy level. So, until then, we'll provide data. We'll do case-by-case, as we have in the past, but we'll build mostly on the CMS decision.

Got you. Thanks for the additional, Connor. And, Ari, all the best for the future journey. Nice working with you. Thanks for taking my question.

Thank you very much. You're welcome.

And thank you, sir. I'm standing by for further questions. As a reminder, to queue up with your question, you can press star then 1 on your touchtone phone. I see no further questions at this time. I will now turn the call over to Larry Jasinski for closing remarks.

First, Vanessa, thank you for your leadership of the call here. And for everybody here, I appreciate the time you've invested in the call today. Stay tuned to the publications and announcements because I've outlined the goals for this year, and we will continually update the progress against these goals. So I wish everyone to have a very good day. Thank you.

And thank you, ladies and gentlemen. This concludes our conference. We thank you for participating. You may now disconnect.