Earnings Labs

Lifeward Ltd. (LFWD)

Q2 2015 Earnings Call· Fri, Aug 7, 2015

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Transcript

Operator

Operator

Good day ladies and gentlemen, and welcome to ReWalk Robotics’ Q2 2015 earnings conference call. At this time, all participants on the phone lines have been placed on mute. Later we will conduct a question-and-answer session and the instructions will be given at that time. [Operator Instructions]. Please do note today’s program is being recorded. I’d like to now introduce our first speaker, Ms. Lisa Wilson, Investor Relations for ReWalk Robotics. Ma’am, please begin.

Lisa Wilson

Analyst

Thank you, Roland. Good morning and welcome to ReWalk Robotics’ second quarter 2015 earnings call. This is Lisa Wilson of In-Site Communication, Investor Relations for ReWalk. With me on today’s call are Larry Jasinski, Chief Executive Officer, and Kevin Hershberger, Chief Financial Officer of ReWalk. This morning the Company issued a press release detailing financial results for the three months ended June 30, 2015. This can be accessed through the Investor Relations section of the ReWalk website at rewalk.com, and you can also access the webcast of this call from there. 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 statement 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 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 for the next two weeks. You’ll find the dial-in information in today’s press release. The archived webcast will be available for one year on the Company’s website at ReWalk.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on August 6 of 2015. 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 · Jefferies. Your line is now open. Your question please

Thank you, Lisa. Good morning everyone. Thank you for joining us. This morning we issued our financial results for the second quarter of 2015. We placed 12 systems in Q2 compared to 10 in the prior year quarter. Although Q2 growth was slower than we expected, demand generation in terms of qualified leads and completed filings from reimbursement grew substantially. We expanded and modified our training program to more effectively qualify users and to better assist individuals in advancing the reimbursement applications. In July, we launched a significant new product that will increase the number of users and offer them a better walking experience. Its streamline design, which eliminated the need for a backpack, will offer greater comfort. The ReWalk 6.0 with its new design offers superior features over any product in the market or in clinical trials today. Our top line results were impacted by two primary factors during Q2. The first, timing of reimbursement decisions; we had some reimbursement wins early in the quarter that led us to believe the reimbursement process for additional claims would be completed sooner. However, the insurance decision making process are moving at a deliberate but slower pace. As we seek to expedite the process, we are working closely with insurers on each and every pending claim. In parallel, we have expanded efforts to educate insurers and the market more broadly about the health benefits and the cost savings that come from being able to walk again. The second factor is the length of the sales cycle. Simply put, it is taking longer to convert our solid pipeline of leads into actual sales. This is common for new technologies in emerging industries, and to address this we have modified our sales efforts to include a more integrated team based approach that now includes…

Kevin Hershberger

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Thank you, Larry. Our revenue was $610,000 for the second quarter of 2015 compared with $500,000 in the second quarter of 2014. Of the 12 units placed during Q2, seven were placed for personal use with the balance placed for use in rehabilitation centers. The slower ramp and timing for patients to complete the qualification to purchase cycle impacted the results in the U.S. and in our international markets. We remain encouraged with the interest and the growth in our pipeline of leads in insurance submissions which we believe will build our revenue base going forward. During Q2, we recorded a gross profit of $60,000 compared to a gross loss of $225,000 during Q2 2014, reflecting the positive impact of moving manufacturing operations to Sanmina in the second half of 2014. Additionally, we continue to see strong ASPs in our direct market, especially with insurance reimbursements in the U.S. R&D expense increased to $1.4 million for the second quarter of 2015, compared to $1.1 million in Q2 2014 as we invested in R&D for the ReWalk Personal 6.0 system and advancing additional next-generation ReWalk devices. SG&A expense grew to $4.5 million during the second quarter of 2015, compared to $2.5 million during the same period in 2014, driven by ongoing market development activities following our FDA clearance, investment in the reimbursement team, marketing activities related to the rollout of ReWalk Personal 6.0 and the cost of being a public company. Net loss was $5.8 million for the second quarter of 2015, compared to a net loss of $4.7 million in the second quarter of 2014. On a non-GAAP basis, net loss for the second quarter of 2015 was $5.2 million compared to a net loss of $3.7 million in the prior-year quarter. As of June 30, 2015, our balance sheet remains strong with $31.2 million in cash, cash equivalents and no debt. With that, I will turn the call back over to Larry.

Larry Jasinski

Analyst · Jefferies. Your line is now open. Your question please

Thanks Kevin. ReWalk robotics is leading an emerging industry. The development of this industry and of our Company depends heavily on building programs and infrastructure that will support global growth and expansion. This begins with demand qualification, relies on extensive training programs and requires successful reimbursement for most users. In Q2, the ReWalk training programs received certification by the Federation of State Boards of Physical Therapy for continuing education credit in 22 states. That not only validates the high caliber of our extensive training standards and program protocols but also demonstrates the growing acceptance of exoskeletons within the broader community. We continue to make good progress, executing on our broad reimbursement strategy as well. This includes, first, educating and gaining support from national advocacy groups and societies to support the review process within the insurance industry. Second, working with payers and their internal constituents to significantly expand their understanding of the benefits of the ReWalk device for spinal cord injury patients as they formulate policy and make case-by-case decisions. Third, establishing and providing data for publication about the health and economic benefits of wearing exoskeletons in general and the ReWalk system in particular. We believe we have the right team in place to execute effectively and that all the upfront work they are doing to educate the market will pay off with higher quality submissions and faster and positive decisions in the near term. During the second quarter, two additional large private commercial insurers made positive coverage decisions on behalf of our customers and six of our 12 placements in Q2 were covered by insurance. As we scale the business and more insurers grant coverage, we expect a pace of reimbursement decision making will become more predictable. Our focus remains on helping secure additional coverage for each individual that wants…

Operator

Operator

[Operator Instructions] Our first question comes from the line of Imron Zafar with Jefferies. Your line is now open. Your question please.

ImronZafar

Analyst · Jefferies. Your line is now open. Your question please

Hi, good morning, thank you very much for taking my question. I wanted to ask about the VA channel. I think last quarter you mentioned that there were 38 patients qualified and waiting for a device and I think you said the same number today. Is that suggesting that there haven’t been any new qualified patients added in that channel or that some have actually gotten a unit and others have replaced them to keep that number at 38? I am just trying to understand what’s going on in the VA channel a little bit better.

Larry Jasinski

Analyst · Jefferies. Your line is now open. Your question please

Certainly. With the VA, the number of 38 is the same. It hasn’t changed quarter over quarter. We are seeing that many veterans are waiting a broader policy decision in other parts of the country from the VA before they move through the qualification process. Presently to get trained in a ReWalk, it has to be done in the James J. Peters VA in Bronx, New York, and for most of those people that are enquiring they are in geographies where they can’t get to the James J. Peters VA and they are waiting for local guidance. So the others that have enquired have simply held back a little bit until this policy statement that we are aware that the VA is working on is issued on a national basis so they know how and where and when to go get a ReWalk.

Imron Zafar

Analyst · Jefferies. Your line is now open. Your question please

And do you have a sense of why that hasn’t happened yet in terms of a national VA policy saying that they would cover the technology? Is it just a waiting game at this point or is there any particular reason why they are taking so long to do so?

Larry Jasinski

Analyst · Jefferies. Your line is now open. Your question please

I’m not aware of any specific reason that is holding them back or slowing them down, I know they have worked very hard in examining the data and in formulating a policy. They have asked us for a great deal of input, have indicated a lot of the progress that they have made, and my understanding is that it is being reviewed now at the highest levels of the VA but I can’t forecast the timing of the government beyond that.

Imron Zafar

Analyst · Jefferies. Your line is now open. Your question please

Got it. And then one last quick question on 6.0, is your sense that there might be some pent up demand ahead of that launch, that recent launch, in other words were there patients waiting for maybe the availability of that iteration in order to actually get the system?

Larry Jasinski

Analyst · Jefferies. Your line is now open. Your question please

Yes, I think the best example I have is our very first sale. This is a gentleman who has used all the different exoskeletons but he was waiting for one that fit his body better and fit him perfectly and he was our first buyer because as he saw the way this fit him and worked, it solved some of the fitting problems due to some specifics of his anatomy and we are aware of others that are like that. So we believe that the new 6.0 will be able to offer a exoskeleton to a larger audience and a few people that were holding back. At least one has already come forward and we expect several more.

Imron Zafar

Analyst · Jefferies. Your line is now open. Your question please

Okay. And those centers that have already been trained on 6.0 – I’m sorry, on the prior gen, is there additional training that is now required with the 6.0?

Larry Jasinski

Analyst · Jefferies. Your line is now open. Your question please

There is no specific training required within the rehab center where they’re getting their program, but at the time they get their product we will just train them a little differently on the specifics feel of the device because it is a little different for handling. For example, changing the battery is now much easier and simpler, putting on the straps is now much easier and simpler. So it’s – we will have to train it each individual as they get the new system, but fundamentally it doesn’t require anything further at the rehab centers.

Imron Zafar

Analyst · Jefferies. Your line is now open. Your question please

Okay. Thank you very much for taking my questions.

Operator

Operator

Thank you. Our next question comes from the line of William Plovanic with Canaccord Genuity. Your line is now open. Your question please.

William Plovanic

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Hi, thanks, good morning. So of the seven personal units that you sold in the quarter, how many were outright sales versus how many were leases?

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Of the seven units in the U.S., we have…

Kevin Hershberger

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Three replacements.

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Three replacements.

Kevin Hershberger

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Yes.

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

And four were outright sales.

Kevin Hershberger

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Yes, I’m talking globally, globally.

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Globally, yes.

Kevin Hershberger

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

So three were rentals.

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

So but for the seven in the U.S.…

Kevin Hershberger

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Those were all sales, all the ones in the U.S.

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

All seven in the U.S. were sales, okay.

William Plovanic

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Okay. And then you said that you had two commercial insurance approvals. What geography were those located?

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

They were in the northeast.

William Plovanic

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

So they are in the United States?

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Yes, both were in the United States, yes.

William Plovanic

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

And then I am just trying to hand around this. So you have a lot of leads in the pipeline. There is a lot of discussion regarding kind of taking longer to kind of put these through. What exactly is that bottleneck? Is that infrastructure on your side, is it data that you need to understand, is it understanding each payer? What do you need to start being more streamlined in processing these and have more visibility and accuracy in predicting the timeline to close the sale?

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

I think there is two or three types of things that have a lot to do with that. The main one is education within the insurance groups. As they get more and more information from the case managers and more publications, I think they are going to move more quickly because they tend to be asking a lot of questions. And among the questions are how often are they using it, do you have a way to monitor it, types of things like that. A secondary factor is some of the users are taking a little longer to finish the training. I’ll give an example, the first unit that went out of Spaulding with a young man, it took him a little longer to get his core strength built up to a point where he was comfortable taking the unit home. So he stayed and did some extra training. But that was one of the two commercial users in the United Sates that approved.

William Plovanic

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

And then I think, I am sorry, you threw a lot of numbers out at us. I think said you had 170 leads at the end of Q1, 240 leads, and then something about leads submitted, and I think you said you had 69 leads submitted going into the quarter versus like 31 last quarter. So if I look at this, you closed on – of the 31, you closed on seven personal, so you closed on about a quarter of them. Should we think that just use that as kind of a baseline closure rate going forward, so if you have 69, maybe you will close a quarter of those going into the fourth quarter or we’re just not at that level of visibility yet?

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Okay. Well, you did get all the numbers right. Actually the submitted number is 59 right now that are pending. But to answer your question, it is still too early to know. I don’t think we have developed a trend that we can provide you yet. I think in the next two or three quarters that percentage will emerge and we’ll get a sense of whether it is going to be a large percentage or a modest percentage. We do not know that yet.

William Plovanic

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

And then I know Imron asked on the VA, and this is my last quarter, is this something, I know, so it is at the highest levels, you have been in discussions with him, you would know the pace and the tone of those discussions. In your opinion, do you think this is something that will be a 2015 event or is this going to flow into 2016 in regards to setting that national VA policy? Thank you.

Larry Jasinski

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

Well, the tone of the discussions with the VA has been positive, entirely positive. They really do care and are trying to get this done. They are trying to hire and build the infrastructure to do it and have policies to clear. So all contacts have been positive, the only frustration is the pace, and I think they are very close to finishing but it is impossible for me to commit the government to a date, although then I think April 15th we have to pay taxes, that is the only date I can give you.

William Plovanic

Analyst · William Plovanic with Canaccord Genuity. Your line is now open. Your question please

That’s all I have. Thank you.

Operator

Operator

Thank you. [Operator Instruction] Our next question comes from the line of Matt Taylor with Barclays. Your line is now open. Your question please.

Young Li

Analyst · Matt Taylor with Barclays. Your line is now open. Your question please

Hi, guys. This is Young Li, in for Matt Taylor. Thanks for taking our questions. I guess just to start off, regarding the Bronx VA, I am just kind of curious, and sorry if I missed this if you mentioned in the call but just wondering, during the quarter what’s the, I guess the training pace as well as the selling pace at the Bronx VA like? Were there a lot of additional patients trained at the center? Just any color would be helpful.

Larry Jasinski

Analyst · Matt Taylor with Barclays. Your line is now open. Your question please

Certainly. For the James J. Peters VA in the Bronx, I’d break it into two categories. First, this is one of the leading research centers in the world. So they have a high level of activity that reflects research and that is really a lot of what will benefit the community in the months and years to come. But I think you are focusing a little more on the clinical side. They have completed the training of their clinical department and are actually starting, at least I know of one individual they are already processing. But they are at the beginning. I know they are doing some physical plant infrastructure, for example, to enhance the ability of placing of the training center for clinical. But they are just at the beginning and this is a little bit of the VA. It took some time to build the physical plant, to get the unit in, to hire the people, to get them training. And the overall VA policy is starting with VA Bronx. But they are really just at the beginning of training individuals at this time for a clinical setting to take them home.

Young Li

Analyst · Matt Taylor with Barclays. Your line is now open. Your question please

Okay. Got it. And I think – correct me if I am wrong, but I think you mentioned the length of time to train patients on the rehab unit might have slowed a bit. Is that right and if so what’s driving that slowdown in training?

Larry Jasinski

Analyst · Matt Taylor with Barclays. Your line is now open. Your question please

Well, I gave an example of a young man that took some extra time in his training in order to do it well and be well prepared to be home. It varies highly by individual. I can’t say there is a specific trend in our clinical studies. The average time to ambulation at an independent level was about 15 sessions, but we had a broad range. And I think the numbers, it’s just a little early to put big numbers on it. Most people are having successful trainings at this point but it varies depending on the individual approach, their level of injury. So it isn’t a very general number that I can give at this point.

Young Li

Analyst · Matt Taylor with Barclays. Your line is now open. Your question please

Okay. Got it. Thank you very much.

Operator

Operator

Thank you. I’m showing no further questions at this time. I would like to turn the call back over to Mr. Larry Jasinski for any concluding remarks.

Larry Jasinski

Analyst · Jefferies. Your line is now open. Your question please

Okay. Well, first, I’d like to thank everybody for the time and we appreciate you joining us this morning. So have a good day. And if you have other questions, we’ll be glad to connect with people individually. Thank you.