Lifeward Ltd. Q1 FY2021 Earnings Call

Good day, and thank you for joining us. Welcome to the Q1 2021 earnings conference call for ReWalk Robotics Limited. I will now turn the call over to your speaker today, Ori Gon. Please proceed.

Thank you, Misty. Good morning, and welcome to ReWalk Robotics First Quarter 2021 Earnings Call. This is Ori Gon, ReWalk's Chief Financial Officer, and with me on today's call is Larry Jasinski, our Chief Executive Officer. This morning, the company issued a press release detailing financial results for the 3 months ended March 31, 2021. This press release and a webcast of this call can be accessed through the Investor Relations section of the ReWalk website at www.rewalk.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 as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to ReWalk's management as of today and involve risks and uncertainties, include those noted in this morning's press release and Rewalk's filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in forward-looking statements. ReWalk specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. A telephone replay of the call will be available shortly after completion of this call. You will find the dial-in information in today's press release. The outside webcast will be available on the company's website. For the benefit of those who may be listening to the replay or archive webcast, this call was held and recorded on May 11, 2021. Since then, ReWalk may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. And with that, I'll turn the call over to ReWalk's CEO, Larry Jasinski. Larry?

All right. Thank you very much. Good morning, everyone. I am pleased to report that we had a solid Q1 and are on track for our goals in 2021. Q1 was the beginning of a transition from COVID limitations to more normal operations as our customer base is making progress towards returning to training and into the clinics. Q1 sales were $1.316 million compared to $0.760 million in the prior year quarter and $1.2 million in the trailing quarter. For our core product offering, the ReWalk 6.0, we expect continued progress with our current base of target candidates which is at 168 qualified individuals. 82 of those are in Germany, where we have the strongest coverage position as we emerge from COVID, 56 are in the U.S., which consist primarily of BA and workmen's comp individuals. 30 are in the U.K. and within their litigation system. As U.S. progress occurs with CMS, we will seek to move larger numbers of Medicare/Medicaid individuals into our qualified pipeline. This current base of potential ReWalkers combined with our full direct sales force in these 3 geographies and the expected reopening for access to these training centers provides us with a sufficient base to our year-over-year growth goals. For the ReStore product offering, the reopening has allowed the expansion of data generation and reentry into target accounts. We have worked with several of our KOLs to develop a symposium for this year's ACRM conference, which examines the role of robotic systems like the ReStore Exo-suit in achieving the therapeutic goals of high-intensity gait training with patients post-stroke. The reopening will allow reinitiating the clinical studies at Spaulding in Boston, Ability's Lab in Chicago, and at Boston University. Our parallel focus to building data is initiating placements and seeking subsequent contracts with national chains or accounts. We now have 7 clinics with 4 different national groups that are utilizing the ReStore device for broader use within their national programs. We are also advancing contract efforts with our MYOLYN offering and our MediTouch offer with the same chains and others. Our expectations for year-over-year growth rely on ongoing and increasing access to our clinics and customer base, and all current trends in the U.S., U.K. and Germany support our expectation to meet our growth goals. All other financial metrics are also aligned with our planning. Our gross margin landed at 54%. Our operating expenses will be level in almost all efforts beyond sales commission and travel expenses. Our cash position at the end of the quarter was $67.4 million. The combination of growth, margin management, and controlled expenses leaves us with a runway to achieve breakeven operations and to consider other opportunities to build our business. At the start of the year, we identified several key milestones to watch in 2021 that will have an impact on our efforts to develop this new and emerging market. Here is a review of each. The first milestone. In the German Federal Social Court, which is the highest court for social jurisdiction in Germany, a ruling is expected to decide if an exoskeleton, which is an orthopedic aid that replaces the function of legs, enables independent walking and standing, whether it serves to directly compensate for disability. This case was filed in the local social court in May 2017, and the case was denied. It was appealed to the state social court, which overruled the local court and ruled that a ReWalk must be provided. It was then appealed by the payer to the highest social court in Germany, the Federal Court for a final ruling. The court does not provide a specific guideline on timing for a ruling, but our best estimate is mid-2021. A positive ruling would have a significant impact on the landscape by all payers in Germany. Our second milestone, expansion of contracts in Germany, they remain highly active with 2 of the remaining large chains, but final contracts are more likely to be held until the court decision is issued. Third milestone. In the U.S., the successful HCPCS code issuance is actively being followed with multiple activities around pricing, categorization of the exoskeletons, and regarding coverage policies with contractors planned in coordination with CMS. This timeline has some uncertainty, but we are pleased with the progress that has been incurred. And the fourth milestone. In the U.K., the utilization of the ReStore system in NHS evaluation centers is scheduled with patients as they return to the clinics on May 17 with a broader opening in June. I'd now like to turn the call back over to Ori for a review of the financial details. Ori?

Thanks, Larry. As mentioned, our first quarter revenue for 2021 closed at $1.3 million compared to $760,000 in Q1 2020 and $1.2 million in the previous quarter. The increase compared to last year was due to an increased number of ReWalk Personal 6.0 units sold in Germany and the U.S. Regarding our insurance progress. This quarter, we had a total of 6 new insurance decisions to place a device for a new rental or a direct purchase and 7 conversions of previously rented devices. Our current pipeline of active rentals consists of 18 personal 6.0 devices and 2 ReStore rentals. As Larry mentioned, we have additional active programs with different U.S. accounts currently analyzing the ReStore device during their stroke therapy. Turning into our gross margins. In the first quarter of 2021, our gross margin was 54% compared to 49% in the prior year quarter. The increase is mainly due to our higher number of units sold, with offset due to higher inventory write-off and policies for service and warranty. Regarding the operating expenses, our Q1 2021 operating expenses landed at $3.7 million compared to $4 million in the prior year quarter. This decrease is mainly due to lower R&D spend as we have implemented cost reduction efforts in the beginning of last year with the major ReStore project completed and to adjust due to the COVID-19 impact. Looking at our operating expenses compared to the previous quarter, we see that the main change is in our sales and marketing activity, which is almost entirely due to our PPP loan forgiveness which was booked as a reduction of sales and marketing in the last quarter. To recap the quarterly results, our net loss for the first quarter of 2021 was $3.1 million compared to a net loss of $3.8 million in the first quarter of 2020. This is due to our increased revenue and reduced spending. Our non-GAAP net loss for the first quarter of 2021 was $2.8 million compared to $3.6 million in the first quarter of 2020. We ended the quarter with $67.4 million in cash, which includes our $40 million from our February equity fundraise and $13.8 million received from warrant exercises. With that, I'd like to turn the call back to Larry for some final remarks. Larry?

Thank you, Ori. I'd like to further discuss our status regarding the 4 major goals we defined at the start of the year within the context of our overarching business strategy. We've laid out the baseline for year-over-year growth with our existing products, which build on coverage, market access, a fully active sales team and expansion of data. We also anticipate our path to being a sustainable and profitable independent operating entity may require a combination of growth in the base products and successful internal and external development programs. Technologies we own and could gain access to, combined with our current infrastructure and our current financial position is an ideal mix to achieve these goals. While most focus is on short-term commercial operations, we have active efforts pursuing new indications for our soft exo-suit offerings paired with a parallel payer strategy. We will also examine new opportunities that fit our operating goals that could benefit in partnership with our organization. Thank you very much for your time and interest today. I'd like to turn the call over to questions at this stage. Operator, if you could please go ahead with the instructions.

Your first question is from Sean Kang with H.C. Wainwright.

So my first question is regarding insurance discussion in the state. So what is the progress you've made regarding the payer discussion after you got the CMS? And is there anything else like in terms of clinical data to kick in to help the discussion?

Yes. This is Larry. Thank you, Sean. Basically, we have a lot of interactions occurring with CMS, which we find incredibly valuable in giving us guidance to answer the open elements to allow contracting, specifically establishing pricing, establishing a final categorization and establishing a path to contracts. So these 3 pathways are all underway, and they're at a stage right now where they're primarily interaction with segments within CMS. And with some patients. So we are in process, I guess, there's no specific short-term milestone, but really good interaction moving it forward. Relative to data, we have a very solid block of data that we believe will support coverage exactly as it is currently set up. That has been successful in Germany, and it's gotten us through the HCPCS code issuance. But we do have additional data, and we've outlined some of it in prior calls. The VA Coop Study, which was a 160 patient randomized trial, I've discussed in the past. We have no control over when they publish it, but they will publish that sometime in the coming months or so depending on the VA. Secondarily, within our control, we have established a study looking at the economic results for a patient who's been able to walk again compared to a patient or that patient prior to their walking and what effect it had on their health. So we will have more data on a consistent basis around ReWalk and obviously, with the ReStore as well. But we don't believe they're absolutely necessary for coverage, but we think they're very helpful.

I see. That's helpful. I have a question regarding your cash position. You mentioned that it could allow you to explore further growth opportunities. Was that just a general statement, or do you have a specific product in mind?

We would differentiate our success into two areas: our programs at Harvard University and their associated groups, and the products we aim to advance and bring to market. This includes developing proprietary technology specifically designed for home use after a stroke, addressing a significant unmet need for an affordable system. Additionally, we will explore all options and consider external opportunities if we identify something appealing.

I see. So home use for stroke. So it has been basically a home used version of ReStore, I guess, right?

Well, conceptually the same, but the difference would be a much simpler, less expensive device that can be easily handled at home by an individual. ReStore product is designed specifically for the clinic, and it can help higher volumes of patients. You put in X number of patients per day. So it's used repeatedly and it has to be set up differently, and there's a lot in terms of durability requirements. A home use product would be for a single individual at a much lower cost because you don't have to have the level of design for clinic and clinical use. So it's a simplified version of it, but it is offering the 1 primary feature that the ReStore offers that no other product has been able to achieve and which seems to make a major difference in the success of regaining and relearning patterns, and that's propulsion or lifting the heel forward. That is the key feature of the Reboot program, as we call it, which is a significantly different product, but the same concept as ReStore.

Your next question is from Swayampakula with H.C. Wainwright.

This is RK from H.C. Wainwright. Certainly a very encouraging quarter and a good start for 2021. So thinking about your backlog, you stated you have 82 cases pending in Germany. And at the same time, you're also waiting for the Federal Court to issue its decision. How many of these 82 cases are actually entangled within that decision in the sense? Because you have had previously, I think, 3 or 4 insurance groups that had had contacts with your folks, correct?

Right. Ori, do you want to pick up that one?

So RK, the question is how many of the 82 is subject to the social court case or is within a social court case?

Yes.

Okay. Let me pull it up. I believe it's in the neighborhood of 30 cases, but I want to verify that. So give me 1 minute. I'm just opening it up. So yes. It's 30 cases. 30 cases of the 82 are currently in social court, and they will be affected by it at the end of the day.

Yes, I understand. That's great. I have a similar question regarding the 56 months in the U.S., especially since some individuals might be going through the VA system, which isn't affected by the CMS or HCPCS code. I'm trying to clarify where we stand with the VA study, and I believe those going through the VA system may have a better opportunity to obtain the product. Is my understanding correct?

No. I think your thinking is correct, and it's similar to ours. The VA's national policy has provided these systems routinely to patients who qualify. So of those 56, the majority are VA, or we might have the specific number and I'd grab it quickly in a minute. But the key element is the VA is being open. They're running about -- depending on the region of the country, about 25% to 50% open. So we were sitting at 0 most of last year for this group. So we've made really good progress, particularly in the southeastern and central part of the United States. We're a little behind in the -- what we see in the western and northeastern part of the United States relative to the VA being as active. So that pipeline should open up, and those patients do have a coverage policy. So if we can get them trained, and they have a successful training, we can provide them systems.

Perfect. Certainly encouraged by the ReStore getting relaunched. So should we think of ACRM conference being the place where you would potentially put all your energies into getting that relaunch start-up? And also, in the past 1 year, what have you kind of learned as you are getting prepared for this relaunch of the ReStore product?

Our efforts and plans for the relaunch are set ahead of the symposium, with the ACRM conference scheduled for September. We consider this conference significant due to the ongoing positive data, and we believe the discussions and presentations of further data will benefit other sites. Currently, our main short-term focus for the launch has been on national accounts, as we are conducting evaluations in several large chains. If these evaluations proceed as anticipated, we anticipate expansion in those chains. The launch is already in progress due to the evaluations that have commenced in at least four major groups, three in the U.S. and one in the U.K. The ACRM conference will support us, and we also look forward to more published papers from the original study sites that have resumed activities at Spaulding.

And your final question is from the line of Martin with Cantor Holdings.

I have a few questions that are related to some developments this quarter. First, I noticed that you added new members to your Board in November, one of whom is Randel Richner, a specialist in the CMS area. Can you share more about her and the value she brings, particularly in relation to the growth of your business in the emerging U.S. market and the importance of getting the coding right? I believe this addition is quite different from your previous Board members. My second question is about your comments regarding the fourth quarter, which seem to indicate a positive surprise. Can you elaborate on how the second half of the year may unfold in terms of potential upside over your baseline expectations? Finally, I want to address the unusual activity surrounding your stock. It appears that there is a significant oversupply of shares, particularly following the offering in March. Do you think we are nearing the end of this oversupply? Despite the stock looking very undervalued, there seems to be ongoing selling pressure. What insights have you received from H.C. Wainwright, and what do you know about the situation?

Let me address the first two questions, and then I'll ask Ori to respond to the third. Regarding our Board and the successful recruitment of Randel Richner, there is a strong consensus among the management team and the Board that reimbursement has been a significant barrier to advancing innovative technologies. Randel has a wealth of experience, having led health care policy at Boston Scientific for many years and successfully building that program. She later founded her own company focused on reimbursement, which she sold after it experienced substantial growth. Additionally, she has been actively involved with the University of Michigan School of Public Health. Her extensive background and up-to-date engagement with CMS are critical. She has been instrumental in guiding many companies through the reimbursement process as part of the Medical Device Manufacturers Association. Therefore, her joining our Board was a deliberate effort on our part. We believe she can provide value to many companies, and we are fortunate to have her with us. She has solidified our policy approach and provided guidance in connecting us with the right people for inquiries. This was a targeted effort to fill a specific gap, and we are delighted to have her on the Board. Regarding your second question, we have not provided a specific forecast at this time due to the uncertainty created by COVID. However, we have discussed our expectation for year-over-year growth as the year continues, given the number of patients, including those in the German courts and the VA, who are fully qualified and ready to move through the system. The average cycle time to transition these individuals after successful training and deployment is about six months. The growth from these patients will largely depend on market conditions in Q2 and Q3, which will determine our annual success. We anticipate a strong second half of the year, but we must be cautious due to the ongoing COVID waves. Ori, would you like to comment on share activity?

Yes, I can. We don't have visibility into the various activities happening since we obviously don't control them. However, I will mention that on March 11, we filed an S-1 related to the February fundraising, which became effective with the SEC on March 19. This might have led some shareholders to sell their shares in the open market, but we don't control that. So I have nothing more to add on this matter.

Any other questions for today?

There are no further questions. I will now turn the call back over to Larry.

Okay. Thank you very much for everyone who joined today. We appreciate your time and your interest. Please stay tuned to our upcoming information and publications, and have a good day. Thank you very much.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.