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Lifeward Ltd. (LFWD)

Q1 2020 Earnings Call· Thu, May 28, 2020

$7.05

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Transcript

Ori Gon

Management

Hello. Good morning, everyone, and welcome to ReWalk Robotics First Quarter 2020 Earnings Call. This is Ori Gon, ReWalk’s Chief Financial Officer, and with me on today's call is Larry Jasinski, Chief Executive Officer. This morning, the company issued a press release detailing financial results for the three months ended March 31, 2020. 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 statement 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 the information available to ReWalk management as of today and involve risks and uncertainties. Including 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 the 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 archived webcast will be available on the company's website at www.rewalk.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 28, 2020. 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 Jasinski

Chief Executive Officer

Thank you, Ori. Good morning, everyone and I appreciate your time and interest. The first quarter and activities through May had significant progress in targeted areas and was substantially impacted by the general shutdown from COVID-19. Here are the key activities that occurred so far in 2020. First, successful execution of coverage contracts with the number one rated and another top five insurer in Germany, which have been publicly disclosed. Additional contracts with other SHIs have also become active, although the groups did not make public announcements. There was also completion of a binding offer placed and installed within the procurement system with the national social health insurance coverage in Germany, and we now have expanded later stage talks with multiple other groups that are seeking similar type contracts. Second, modification of our agreement with Harvard University's Biodesign laboratory to expand their focus and resources to develop a telehealth remote home therapy exosuit. Third, editorial’s published on the ReStore technology in the UK on clinical value and results, further publications from Harvard on exosuit technology, along with upcoming publication of the results from the clinical trial conducted for FDA clearance. Fourth, our CMS application for consideration of creating a level two Healthcare Common Procedures Coding System, generally knows as the HCPCS code for the ReWalk exoskeleton now has a public hearing scheduled for June 1. And fifth, we have successfully added two new product groups via distribution agreements that will be initiated at the start of Q3. Next, regarding our revenue, financial operations and more detail on the five points highlighted a moment ago. The effect of the COVID-19 pandemic on our business and revenue is significant because our products require in-person contact to complete the sales process. This includes delivery of the system and conducting training in some cases,…

Ori Gon

Management

Thanks Larry. Our Q1 revenue was $760,000 and as Larry mentioned, it was affected by the COVID-19 pandemic. A substantial part of our transaction are normally finalized in the last three to four weeks of the quarter. So the clinic shut down in March impacted our ability to potentially close ReStore rentals and sales. We were also not able to complete the delivery of several ReWalk Personal 6.0 devices during the quarter. The revenue split by product is the following: our Personal 6.0 products had a total of $714,000 and the Rehab ReStore device had a total of $46,000. On the reimbursement side, we had four new rental approvals and full conversions of previously rented units during the first quarter. At the end of the quarter, we had 13 active SCI rentals and seven ReStore trials. This rental pipeline represents $1.5 million in revenue. Our total number of SCI pending insurance cases was 115 at the end of the quarter with 98 of them in Germany and 17 in the U.S., compared to 145 at the end of 2018. The U.S. pipeline list, private insurers and do not include the VA opportunities. The reduction in pending insurance cases compared to previous quarter is because we are no longer pursuing appeal with commercial payers in the U.S., as we shifted our focus to the VA, walkers comp and obtaining broader coverage through CMS. Our gross margin in the first quarter of 2020 was 49% compared to 59% in the prior year quarter, this decrease is due to the reduced revenue generated this quarter from our ReWalk Personal 6.0 device. Regarding the operating expenses, our Q1 2020 OpEx decreased by $500,000 or 11% compared to the prior year quarter and remain flat compared to the previous quarter. The decrease compared to the…

Larry Jasinski

Chief Executive Officer

Thank you, Ori. I'd like to provide additional detail on each of the driving factors for our creation of these new markets and establishing this industry. So part one, the pathway for broad and well-defined coverage has been the key limiting factor for those seeking the benefits of walking once again. ReWalk has been the leading and sole company pursuing insurance coverage for home-based exoskeletal walking. The path started in Germany and the recent results there came from years of effort and by establishing data and systems. We have made three public announcements where the companies were identified. One is TK, which covers 10.6 million Germans, has been voted Germany's best health insurance company for 13 years in a row and has moved swiftly to procure its first payment under the contract during the first quarter. The second is DAK-Gesundheit, it is the third largest SHI in the country, provide insurance for 5.6 million people. Its history dates back to 1775, making DAK Germany's oldest health insurance company. Third is DGUV, which comprised of 36 different DGUV and insurers and covers nearly 83 million Germans against work-related commuting, school accidents and other occupational diseases. These new policies will allow any eligible beneficiary with a spinal cord injury SCI to seek procurement of a ReWalk 6.0 exoskeleton system. They will help set the standard for exoskeleton procurement in Germany. A quote from Mr. Thomas Bodmer, Board Member at DAK-Gesundheit is “The advantages of this highly innovative supply have convinced us, the quality of this complex care is important to us. This is where the contract comes into play by clearly describing and regulating the interaction between the manufacturer, physiotherapists and orthopedic technicians in the contract on medical aid for the first time. In this way, we make it possible for those…

Operator

Operator

Thank you. [Operator Instructions] And your first question is from the line of Mr. Rama.

RK

Analyst · Mr. Rama

This is RK from H.C. Wainwright. Good morning, Larry and Ori.

Larry Jasinski

Chief Executive Officer

Okay.

Ori Gon

Management

Yes, okay.

RK

Analyst · Mr. Rama

Couple of quick questions. Regarding the CMC meeting on June 1, which is coming up pretty soon here, what else does CMC need to do before they can provide the dollar amount for reimbursement?

Larry Jasinski

Chief Executive Officer

Well, the first step is issuing a temporary code and this public hearing is really the session where they will go over their recommendations. They will hear the comment from our company, from some of our clinicians, and one of our users; and they will hear other public comment either for or against establishment of this new code. So, their decision will follow shortly after. The pricing and cycles of establishing CMS codes have varied a little bit, but generally they match the calendar year for the government, which starts in October of this year. So, our anticipation is, if they elect to establish a code independent, and we'll see how we do on Monday, June 1, then pricing would be something that would be addressed probably after that in the contracting phase. So, we don't have specific control as to when they would establish pricing. But that is the cycle of time which we get to address it.

RK

Analyst · Mr. Rama

So specifically, would that be for the year 2021 or the year 2022?

Larry Jasinski

Chief Executive Officer

Well, the code, it would be October 2020. So, it'd be really effective forward. Relative to pricing, it will probably happen more in negotiations in Q4 and Q1 next year. So, we're basically looking in a nine-month type cycle.

RK

Analyst · Mr. Rama

Okay. That's good. And then regarding the German insurance contracts, has – since you have announced a month, 1.5 months ago, what additional color could you provide in the sense as the countries are opening up post COVID-19? Have you seen any outflow of product to some of these insured lives under the German contracts?

Larry Jasinski

Chief Executive Officer

Yes, specifically almost every unit where we've been placing here from the ones that were left over from Q1, we didn’t get to deliver and the early ones are almost entirely within these contracts. And what I really like about them is several of these are patients that have been waiting one person in particular with lot of social media had been waiting almost four years. And from the time that the contract was established till the time she had her unit at home was only a couple of months. So, the actions that we're expecting in this quarter and the coming quarters are going to be very much driven by the contracts. We do expect them to expand, our biggest short-term risk is access to the clinics. As long as clinics stay open and we can get in and they can get trained and they can get their delivery, we will have some good progress, but we can't be certain as to how the market access will be just yet anywhere in the world yet with COVID.

RK

Analyst · Mr. Rama

Okay. And then what is – could you provide some additional commentary on the VA front, and how is the trial continuing to progress, anything in terms of data or publications from them?

Larry Jasinski

Chief Executive Officer

Well, the VA did complete enrollment. They enrolled 161 patients with a target of 160. That was good. They finished the follow-up. My understanding is this is from discussions with the centers on approximately 125 of them, and then the others are in a bit of a holding pattern because they haven't been doing the follow up during the COVID period. So, the pace at which they get the key centers open will have an impact on when they finish the data, and we have no control over those, so they may elect to publish on the 125 where everything's complete or they may finish the other 35 and then publish. So, we originally expected them to be publishing somewhere around year-end Q1 next year, can't tell if COVID is going to slow that down or not.

RK

Analyst · Mr. Rama

Okay. And then the last question from me is, with these new MediTouch products, what sort of synergies should we expect? And also now that they can do some – the patients can handle some of the telehealth operations, does that provide additional help in terms of placements on the product?

Larry Jasinski

Chief Executive Officer

I think both of the two companies that we have brought in are really going to be synergistic because they're at the same call point. We're not going anywhere that we haven't gone before. So, whether it's -- where we're selling the stroke product for the ankle, it's the same group that in the clinic that we're working with, the bigger difference with the MediTouch line is they also offer a home-based unit that can either be provided by the clinic or bought from us directly. So MediTouch has some very unique elements there that flow rather nicely. On the Myolyn product line, the reason it is a particularly good fit for us is they have a contract already in place with the VA, and we will be the distributor for all the VAs in the United States and that'll be our primary focus. These are the exact same patients we're trying to sell ReWalks to. And in the end, we tend to learn that some of our patients don't qualify. They don't have bone density sufficient, for example, but they would qualify for a FES bike where they may be able to improve their bone density and get back into a ReWalk, you never know. But they're the same patients, the same labs, the same clinics. So, we think both these product lines will offer us an improvement in both clinic sales and in-home sales as we work on them.

RK

Analyst · Mr. Rama

Very good. Thank you very much, Larry. Good luck and talk to you soon.

Larry Jasinski

Chief Executive Officer

Thank you.

Operator

Operator

And at this time, there are no further questions.

Larry Jasinski

Chief Executive Officer

Well, I'd like to close the session. First, thank you for everyone who joined for observing the progress with these new markets. We look forward to providing further announcements or press releases as things develop and conduct in our Q2 earnings call in a few months. So please watch your point on to begin. Thanks everybody and have a good day.

Operator

Operator

Thank you. This does conclude today's meeting. You may now disconnect.