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Lifeward Ltd. (LFWD)

Q3 2020 Earnings Call· Tue, Nov 10, 2020

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2020 ReWalk Robotics LTD Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Ori Gon. Thank you. Please go ahead.

Ori Gon

Analyst

Thank you, Brandi. Good morning and welcome to ReWalk Robotics' third 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 and nine months ended September 30, 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 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 November 10, 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

Analyst

Thank you, Ori, and good morning, everyone. Our market development results in the third quarter continue to be very positive and we saw fundamental progress in Germany and with CMS in the United States. In Germany, the insurers are approving trainings at an increasing level as expected, and additional insurers are moving forward with contracts. In the U.S., the Procedure Code K1007 was formally issued and took effect on October 1, 2020. In parallel, ReWalk achieved full accreditation to be a direct supplier to Medicare and Medicaid through the CMS review processes. Regarding revenue, our Q3 outcome was limited by a variety of factors to $747,000. The limitations during Q3 were mostly due to limited market access with individuals and clinics, as well as delayed processing by payers under the current COVID environment. When we look ahead, we are encouraged by the growing pipeline of trainings in process or completed and awaiting supply. We have also strengthened our financial position with the addition of $9 million in gross proceeds we raised in July. Our operating costs were reduced by 6% over the prior year quarter and our original long-term debt of $20 million continues to be paid down monthly and we now have less than $3 million remaining which will be completely paid off in Q1 2021. Operationally, there are several essential measures. Number one, German contracts are working although more so even we would like. As of September 30, 2020 we have active trainings and five completed trainings that are awaiting final decision. We are expanding the pool for training every week. COVID is limiting getting some of the patients in training and we have found paths to move forward to using local clinics and home training. There have also been limitations in processing that we will address with…

Ori Gon

Analyst

Thanks, Larry. Our Q3 revenue was $747,000 million compared to $1.2 million in the prior year quarter. The decrease is mainly due to a lower number of units hold this quarter, compared to the prior year quarter. During Q3, we have received ten new rental approvals in Europe, which represents our highest number of rental approvals in Europe in a single quarter and two units converted from prior quarters. In addition, this quarter we placed our first MYOLYN VA home user device. Our total number of SCI pending insurance cases was 96 at the end of the quarter, compared to 98 in the previous quarter with 84 of them in Germany and 12 is in the U.S. This shows we have stable demand from the end-customer population to our personal 6.0 product. Our quarterly gross margin in the third quarter of 2020 was 52%, and remained generally flat compared to the prior year’s quarter. On the operating expense side, we had a total of $3.5 million this quarter, compared to $3.7 million in the prior year quarter and $3.6 million in the previous quarter. The main decrease compared to the third quarter of 2019 was in the R&D where we have decided to reduce our spending with the ReStore development completion and invest a higher portion of our spending on the commercialization efforts. To recap the quarterly results, our net loss for the third quarter was $3.3 million, compared to a net loss of $3.4 million in the third quarter of 2019. Our non-GAAP net loss for the third quarter of 2020 was $3 million, compared to a non-GAAP net loss of $3.1 million in the third quarter 2019. We ended the quarter with $18.1 million in cash and our long and short-term loan balance was $3.4 million as of September 30, 2020. With that, I’d like to turn the call back to Larry for some final remarks. Larry?

Larry Jasinski

Analyst

Thank you, Ori. I’d now like to discuss activities for each of our four product franchises and close by reviewing the results, compared to our stated objectives for the second half of 2020. For the ReWalk community and home walking system, I’d like to step back and review what we now believe about the market potential and the path to achieving meaningful market penetration. The promise and benefit of allowing the paralyzed community walk again has both captivated and disappointed the financial markets. The experiences and data from walking together been well reported and are very positive. The disappointment in the market has been because only a few of those that could walk in these systems are actually able to get more. The primary limiting factors have been data, and subsequent coverage policies and contracts. The data expanded significantly over these past six years and that has supported the recent actions by governments issuing codes and the completion of contracts by insurers. For reference on the potential from 2021 forward, if we examine the most up-to-date market information on applicable patients in Germany and the U.S., along with CMS insurance coverage established in a similar fashion as in Germany, these markets are in the range of $90 million in annual revenue with achieving about a 3% market penetration rate. These coverage accomplishments and goals are the next step in achieving true commercial development of this sizable market. The tedious detail of building acceptance of reimbursement has been lengthy. Germany has set the standards and they are now implementing. The U.S. and Medicare system has moved forward with the code and in parallel, the VA already has a coverage policy in place. Now looking at the process of the relaunch for ReStore and the launch of the MyoCycle for exercise with…

Operator

Operator

[Operator Instructions] Your first question comes from the line of Sean Kane [Ph] with H.C. Wainwright.

Unidentified Analyst

Analyst

Hi. Thank you for taking my question. Hello.

Larry Jasinski

Analyst

Hi, Sean.

Unidentified Analyst

Analyst

Hi. Yes. So, you have shown us the code has been - it’s effective now right. If there is – it was – it hasn’t been standing with the dollar amounts?

Larry Jasinski

Analyst

The code is effective as of October 1st. So, yes it is effective. The dollar amount, which we have looked to be set up in a similar cycle that had made a submission, due to COVID, they did not complete the pricing. So, they have left us with pricing will be done with a local MAC. So, each of the individual Medicare contractors will work with us on the pricing and those are some of the meetings that we have now set up.

Unidentified Analyst

Analyst

I see. So, how are you – the investment talks are progressing private payers, now that we have as the CMS code is effecting. Is it helping anyway?

Larry Jasinski

Analyst

In the short-term it has not affected us greatly, I would note. Some of the private payers did support the issuance of the code, which is very important and we are going to try to set up specific contracts with private payers in parallel with working with CMS. But our immediate focus at least for the past few months has been specifically with CMS to get everything aligned, accreditation as well as all of these supporting materials to move that towards the contract. And we’ll be doing similar follow-ups with the private payers subsequently. But we haven’t done any yet.

Unidentified Analyst

Analyst

I see. So – and what is your prompted relaunch or respreads. So it’s entirely a 2021 event like do you have a ballpark timeline for that?

Larry Jasinski

Analyst

We’ve actually started here in October.

Unidentified Analyst

Analyst

Alright. Okay.

Larry Jasinski

Analyst

Yes. So, we’re – and we are fortunate we have accounts that have broadened the product and our focus initially has been a little more national accounts. So we at least have a couple of national chains that have brought the product in for evaluation. During the COVID period, they were simply – we are not taking on any new technology. We are holding in a stay with active products, because they didn’t want to train their physiotherapist on a new technology, because in many cases, those physiotherapists were either furloughed or with COVID, they simply weren’t seeing new technologies. So, we are starting that here in October and that obviously runs well into 2021. But we see a significant amount of our growth next year from those three product lines being able to be effectively launch since they were put on hold with COVID.

Unidentified Analyst

Analyst

One last one. Could you provide a commentary on cash runway and operating expenses going forward 4Q and maybe beyond?

Larry Jasinski

Analyst

Ori, would you take it?

Ori Gon

Analyst

Yes. No problem. So, as mentioned, we entered the quarter with $18.1 million in cash. You can see that our operating expenses are pretty much stable in the last couple of quarters and about 3.5, 3.6 depending on specific quarters. This is currently – this is the current structure of the company. We’ll obviously always monitor and see if we can find other specific segments to be a little bit more efficient. But currently that’s generally the ballpark. And on the cash flow side, I think it’s also, again important to note that we are almost done with the Kreos loan. So, on the cash burn side, we – it will be reduced at the end of Q1. So, this is something we will be over with soon. On the operating cash flow side, you see this quarter landing at about $2.6 million in operating cash burn. So that’s also a very positive improvement if you compare to previous quarters and a year before that. So we’ve done a very significant effort there and with the growth that we hope would come in the future, we can even take it lower.

Unidentified Analyst

Analyst

Thank you. Very helpful. Thank you all.

Operator

Operator

[Operator Instructions] There are no further questions at this time. I would now like to turn the call back over to Larry Jasinski for closing remarks.

Larry Jasinski

Analyst

Thank you, operator, and thanks everybody for joining us today. We look forward to continuing providing information on the growth and development of our markets going forward. And we are in a period where we are finally starting to see these markets reopen which is really important to all of us. So, thanks for your time today. Have a great day.

Operator

Operator

This concludes today's conference call. You may now disconnect.