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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q3
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Executives

Lynn Pieper - IR, Westwicke Partners Michael DeMane - Chairman and Chief Executive Officer Rami Elghandour - President Andrew Galligan - Chief Financial Officer.

Analysts

Mike Weinstein - JPMorgan David Lewis - Morgan Stanley Puneet Souda - Leerink Partners Dave Turkaly - JMP Securities Joanne Wuensch - BMO Capital.

Operator

Good afternoon. My name is Chris, and I’ll be your conference operator today. At this time I would like to welcome everyone to the Nevro Third Quarter 2015 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks there will be a question-and-answer session. [Operator Instructions].

Thank you. Lynn Pieper, of Westwicke Partners, you may begin your conference..

Lynn Pieper

Thanks, Chris. Thank you all for participating in today’s call. Joining me from Nevro are Michael DeMane, Chairman and Chief Executive Officer; Rami Elghandour, President; and Andrew Galligan, Chief Financial Officer. Earlier today Nevro released financial results for the quarter ended September 30, 2015.

A copy of the press release is available on the Company’s website.

Before we begin I’d like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements.

All forward-looking statements, including, without limitation, our examination of historical operating trends and our future financial expectations, which includes our full-year 2015 worldwide revenue guidance, are based upon our current estimates and various assumptions.

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.

For a list and description of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission.

Nevro disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 9, 2015.

I’ll now turn the call over to Michael DeMane.

Michael?.

Michael DeMane

Thanks, Lynn. Thank you everyone, for dialing in today, and good afternoon. I will start today’s call with highlights of our third quarter results and operating achievements and also I’ll provide an update on our U.S. launch progress. And then I’ll cover our global revenue guidance for the full-year 2015.

Following my initial comments, Rami will provide additional depth and color on our U.S. launch. And Andrew will follow with a deeper review of the financials. Andrew will also elaborate on our U.S. and international revenue guidance. Then we’ll open up the call for your questions. Okay. Nevro’s third quarter results, our first full quarter of U.S.

revenue reflected impressive execution for the United States launch of our HF10 therapy, as well as continued international revenue expansion at above market growth rates. Total revenue for the third quarter was $15.4 million, an increase of 78% as reported and 110% using constant currency. U.S.

revenue was $4.5 million in the first full quarter that HF10 therapy was commercially available to patients in the United States. International revenue was $10.9 million, an increase of 26% as reported and 49% using constant currency. Our U.S.

launch performance in Q3 has exceeded our expectations and is consistent with the confidence we communicated previously on the Q2 earnings call and our recent public conference commentary. Moving to guidance, our total revenue guidance is $59.5 million to $61.5 million for the full-year 2015.

This represents total revenue of $23 million to $25 million for the fourth quarter of 2015. The midpoint of guidance for international revenue is $12 million and the midpoint of guidance for U.S. revenue is also $12 million, again both for the fourth quarter. Again, Andrew will go deeper on the quarter results and our guidance later in the call.

So, let me step back for a moment to say a few words regarding Nevro’s competitive position at this juncture. To start, we have a remarkable product.

Senza System which delivers our proprietary HF10 therapy is backed by first-in-class evidence and is the first SCS therapy to achieve an FDA label of superiority to traditional SCS therapy for the treatment of chronic back and leg pain. And it is the first with an FDA approved indication for paresthesia-free pain relief.

And we are fortunate to have an outstanding team. The organization is comprised of dedicated professionals that are immensely talented and focused on raising awareness of HF10 therapy and most importantly delivering the patient outcomes that are the ultimate driver of our success as a company. Third, we have a thoughtful U.S. launch plan.

As you know, over the past five years we have demonstrated impressive commercial traction in Europe and Australia, with exceptional international growth rates over the past six quarters. We are putting that experience to good use and have utilized those vital learning to shape and inform our U.S. launch strategy.

And finally, we are executing really well on that plan. When you marry exceptional people and plans with an effective therapy that meets an unmet need, the results are impressive. The reception for HF10 continues to exceed our expectations.

And as reflected in our guidance, we see tremendous opportunity in bringing HF10 therapy to many patients in need in the United States and worldwide. Changing gears here let me step back for a moment and speak to some important events likely to play out in the quarter and beyond.

Moving to our evidence generation initiatives, we are excited that the SENZA-RCT investigators are scheduled to present 24-month results from our U.S. pivotal study at the North American Neuromodulation Society Meeting in December. With the release of these results, Nevro will now have around two of the four key long-term studies in the field of SCS.

With this study, the SENZA-RCT providing the most rigorous evidence to date for the treatment of both back and leg pain. Regarding the U.S. launch, we are continuing to scale the organization to meet robust demand. We expect to end the year with 100 fully trained reps in the U.S. field organization.

We’ll provide you with our projected field hiring plan for next year when we report Q4 results. As previously communicated, we’ll also provide 2016 annual guidance at that time. And once again expect more color on the U.S. launch from Rami in just a bit. Finally, I want to speak to the two IPR petitions filed by Boston Scientific challenging 155 U.S.

patents that protect our innovation. For the court required cadence, we filed our patent owners’ preliminary response on September 1. As a reminder, due to the nature of the IPR process, in those, preliminary response we were not permitted to provide a full response on the merits nor were we allowed to include our own expert testimony.

We expect the Patent Office to issue a decision on whether the IPR will be instituted by December 1, 2015. If the IPR is instituted we’ll provide a full response on the merits including our own expert testimony in the first quarter of 2016. As you may know, the standard for IPR institution is low compared to the typical District Court standard.

And the institution rates are therefore high. We are prepared for institution and continue to set expectations for institutions, since that is statistically the most likely outcome. We remain very confident that we will ultimately prevail if the process moves forward. Okay, so wrapping up my introductory comments.

Our third quarter results highlight the beginning stages of a very successful U.S. launch, and continued adoption of HF10 therapy in our international markets. Armed with our proprietary HF10 therapy and buttressed with first-in-class clinical data, we’re confident that we can drive deeper and more widespread adoption of HF10 therapy.

And in so doing, help improve the lives of more patients suffering from chronic intractable pain. And with that, let me turn the call over to Nevro’s President, Rami Elghandour to provide some additional launch detail.

Rami?.

Rami Elghandour

Thanks, Michael. As we mentioned our focus U.S. launch strategy is proving successful with U.S. adoption trends to be reflecting our recent international adoption trends both in terms of patient selection and positioning of HF10 therapy within a practice.

This is highlighted by some clinicians fully adopting HF10 therapy in our first full launch quarter, something we did not see at this scale until much later in our international launch. This progress is a testament to the power of HF10 therapy and the outstanding execution of our organization which is delivering on the promise of the therapy.

To that end, our trial conversion ratio for our first full launch quarter was consistent with the 88% trial conversion ratio from both our U.S. RCT and EU long-term studies. Additionally, in everyday clinical practice, the pain scores at the end of trial were comparable to our pivotal RCT results.

Clinicians providing this highly differentiated therapy to their patients particularly note the vast improvements in patients’ quality of life and patients’ ability to return to fulfilling activities long-abandoned or often for over a decade.

When these results are replicated by key clinicians across the country, are backed by pivotal RCT demonstrating superiority and are supported by a world-class organization. The result is a powerful combination that translates into the type of adoption reflected in our initial launch trajectory.

Some other notable metrics from our launch to provide additional color. The patient population we are treating includes both back and leg pain and it reflects our view of the composition of the market. As a result, clinicians who fully adopt HF10 therapy into their practice are able to significantly increase their volume over prior years.

With respect to hiring, we ended Q3 with 92 trained sales reps in the field and we expect to end the year with 100 trained reps as planned. We do expect hiring to naturally slow in Q4 2015 picking up again in Q1 2016. We continue to see top talent in order to expand access to HF10 therapy for patients in the U.S.

and we will provide a hiring target for 2016 when we report full-year 2015 results in Q1 of ‘16. On pricing, we are commanding a modest premium as planned and are closely monitoring to see how competitive pricing trends in the future do to our entry in the market.

On the reimbursement front, Medicare announced the 2016 national average payments for SCS on Friday, October 30. We view the updates as positive with combined reimbursement for our percutaneous trial and permanent implant in the outpatient hospital setting rising 1.7% and in the ASC setting rising 3%.

Finally, shifting to our education and engagement efforts, we have attended a number of conferences to drive broader awareness of our company, HF10 therapy and the pivotal RCT results. Notable Congress is from Q3 included national meetings such as the Congress of Neurological Surgeons and the National North American Spine Society.

We also attended a number of key regional meetings including the California Society of Interventional Pain Physicians and the Texas Pain Society. These meetings collectively provide a meaningful opportunity to connect with physicians, drive awareness of both the therapy and our company and get a true sense of the adoption in the market.

In terms of highlights for upcoming meetings, the 18-month results from the SENZA-RCT would be presented at the American Society of Regional Anesthesia and Pain Management in Miami on November 31, and the 24-month results would be presented for the first time at NANS on Friday, December 11.

This 24-month results presentation will provide the second comprehensive long-term data set on HF10 therapy, further distinguishing the therapy and confirming our commitment to rigorous clinical evidence as a foundation for the future of SCS. And with that, I’ll turn it back to Michael.

Michael?.

Michael DeMane

Thank you, Rami. Now, let’s turn to Nevro’s Chief Financial Officer, Andrew Galligan for a deeper review of our financial highlights and guidance.

Andrew?.

Andrew Galligan

Thank you, Michael. Our revenue for the three months ended September 30, 2015 was $15.4 million, an increase of 78% year-over-year on a reported basis and 110% in constant currency. U.S. revenue was $4.5 million in the third quarter. This is the first full quarter of our U.S. commercial launch which began late May.

International revenue was up 26%, to $10.9 million, from $8.7 million during the same period of the prior year. This represents constant currency growth of 49%. The revenue increase was primarily attributable to continued adoption of the Senza System and the U.S. launch.

Going forward on this call, all revenue growth rates will be stated on a constant currency basis. Europe was again strong, with 445% year-on-year growth, led by Germany and the United Kingdom. Australia was also strong, with growth of 60% compared to the prior-year period.

With respect to our international revenue growth rate, I want to reiterate that we continue to expect very high growth rate of the past six quarters to moderate given our large market shares and other inherent constraints such as capitation in Europe and intensified competition for unconverted accounts.

Gross profit for the third quarter of 2015 was $9.4 million, representing a 61% gross margin up from $5.9 million in gross profit in the same period of the prior year.

Gross margin decreased from its 68% gross margin year-over-year primarily as a result of costs incurred in association with, ramping our operational infrastructure in support of the U.S. launch. Additionally, while costs were primarily incurred in U.S. dollars, international revenue was negatively impacted by depreciation of the U.S.

dollar which negatively impacted the overall gross margins for the period. As we continue to grow revenue we expect to expand margins by improving efficiency and further leveraging our manufacturing overhead.

Operating expenses for the third quarter of 2015 were $27.1 million, compared to $12.4 million in the third quarter of 2014, representing an increase of 118%. The increase in operating expenses was driven primarily by increased headcount and related personnel costs for the sales and marketing organization to support the U.S.

launch, as well as an increase in general and administrative costs associated with being a public company. Loss from operations for the period was $17.7 million, compared to a loss of $6.5 million for the third quarter of 2014.

At the end of the third quarter of 2015 we had approximately $222.6 million in cash, cash equivalents and short-term investments. Turning to our outlook, we are increasing our revenue guidance for 2015. While we previously stated that we would like to get a couple of quarters under our belt before we issue U.S.

guidance, we have received enough information at this stage in the field to provide fourth quarter 2015 U.S. guidance. As mentioned earlier, our worldwide revenue guidance is $59.5 million to $61.5 million for the full year of 2015.

This represents an increase from 2014 in the range of 83% to 89% on a reported basis and in the range of 114% to 122% using foreign currency exchange rates from the third quarter of 2015. This implies total revenue of $23 million to $25 million for the fourth quarter of 2015. Previous revenue guidance included only international revenue.

The worldwide full-year 2015 guidance now reflects U.S. revenue with the recent commercial launch on Senza in the United States. The midpoint of guidance for international revenue was $12 million and the midpoint of guidance for U.S. revenue is also $12 million, both for the fourth quarter.

The international guidance midpoint represents an annual growth of approximately 57% over 2014 on a constant currency basis. We expect operating expenses to be approximately $30 million in the fourth quarter. We plan to provide guidance for 2016 when we report our full-year 2015 results.

At that time and going forward, we plan to provide guidance on an annual basis. Now back to you, Michael..

Michael DeMane

Thank you, Andrew. So, that will conclude our prepared remarks for this afternoon.

Chris, could you please open up the call for questions?.

Operator

Certainly. [Operator Instructions]. The first question is from Mike Weinstein with JPMorgan. Your line is open..

Mike Weinstein

Thank you. First off, congratulations to the whole team, obviously on a very successful early start to the launch. Michael, we haven’t had a chance to chat since we put out our latest survey last week.

And what I’d like to get from you maybe as a starting point and Rami chime in here as well is, some of the anecdotal feedback on the experience that physicians are having with the product.

What are they telling you on the implant experience relative to traditional tonic stimulation with moving to from paresthesia mapping to anatomical lead placement? What is the feedback on that been, is there a learning curve to that? And then, second, what’s the feedback you’re getting in terms of where initially at least physicians are using the product, are they using it in back pain, are they using it in leg pain, is it a mixture? And just any other commentary in terms of where are we on or are they trailing patients as they start to pick up the usage of Senza?.

Michael DeMane

Sure, thanks Mike. Appreciate the question. Well, first of all, let’s just as a refresher for others on the call. If you look at these devices, our own device or any of the competitive devices from a distance they look identical. And what Mike is referring to is dispensing with paresthesia mapping in the OR and rather using anatomic placement of leads.

Everything else is essentially identical. So, what we’re hearing and I think this was reflected quite clearly in your own survey is that there is little to no learning curve in terms of using the product surgically.

And it is something, the differences are such that they are quite attractive relative to efficient and effective use of the OR block of time to do patients. So, I think that has been a key feature for some of the early adopters of the therapy.

Now, before I ask Rami to provide additional elaboration, let me speak to the types of patients that are being, it’s been used on. I would say by design and by a request we started off early almost nearing exactly RCT study in the United States where patients had back and leg pain in significant levels.

And I would say we started off entirely there and it has moved a little bit but it tends to still be quite a number, quite a high percentage of patients with significant back pain and/or mixed back and leg pain.

So, Rami, with that why don’t you address both the learning curve as well as the types of patients that, the profile of patients we’re seeing..

Rami Elghandour

Sure, thanks Michael. So, I think Michael covered both well. In terms of the mapping, we frankly, we see the same positive feedback that we’ve learnt to see internationally but we got there I would say a lot quicker. I think physicians certainly appreciate the efficiency, the procedure and the patient benefits as well.

So, obviously a much less stressful procedure on the patient. So, I think that part has actually been fairly non-eventful. In terms of the patient population that we’re seeing, we’re seeing both back and leg pain.

As I mentioned in my comments that what we’re seeing in the marketplace pretty much reflects our composition of - our view of the composition of the market in terms of the distribution. There is, certainly a lot more back pain patients out there than there are predominant leg pain patients. And we’re seeing that.

And frankly the way we’re seeing it is, as I mentioned, physicians who are fully adopting the therapy are seeing a significant, or can see any significant increase in the volume of the patients that they’re able to treat once they open it up to back pain patient population as well.

So, I would say I guess in some overall, on both of those points Mike, our experience in response has been extremely positive both in terms of the adoption of therapy and if you will the adoption to the anatomical placement of the leads versus the procedure mapping as well as the physicians who were set into their ability to just help a lot more of those patients in their practice than they’ve been able to help in the past..

Mike Weinstein

Rami, it’s couple of things, I thought in your prepared remarks were very encouraging.

I think one, it’s the commentary on conversion from trial to permanent implants, for those that aren’t familiar it sounds like it’s running well above historical market rates in terms of conversion from trial to permanent which means that just referrals are converting to full implants for you guys at a much higher rate? And then second, less the commentary more than just performance.

In the international business despite how high your market share already is in rechargeable segments in Australia and then in other geographies continues to run at a very high rate. I know you guys have been surprised that you haven’t seen a more of a slowdown to date.

Can you just kind of talk about the international experience and where you’re still seeing share gains geographically? Thanks..

Michael DeMane

So, I’m going to ask Rami to weigh in. But let me go back to something we’ve talked about on a number of the calls so far. And that is the extent to which we are expanding the market versus taking share.

I do think that we are being helped by the fact that we are going after here to for wholly treated patient populations, patients with significant back pain, those patients are in the pain clinics, in the pain practices. And they have been historically poorly served and we are treating them. And they are being treated effectively.

So, I do think that has, if you will, ease some of our growth rates in those markets. That said as Andrew mentioned on his comments, looking forward, we do think that it is going to be harder to get those sort of numbers in terms of growth rate going forward in those international markets.

But of course if there are patients out there requiring treatment, we’re happy to provide our therapy for that.

Rami, do you want to?.

Rami Elghandour

Yes. The only other thing I would add Mike, I mean, it’s certainly the international sales organization has just done a phenomenal job of executing and continues to execute at an incredible high level, which is something we appreciate your recognition of that.

I would say, I think the interesting thing for us is that in terms of why we continue to grow? At least our thesis is that, if you look at this market and step back, this is a very high level point. But it’s been a market that’s very much been driven by kind of features and benefits and technology.

And we obviously have taken a very different tack for this market in terms of going out with evidence and outcomes.

And I think the fact of the matter in the presence of the clinical evidence of SENZA-RCT results over the last 12 months I think we’ve continued to see encouraging growth with a combination of that clinical evidence and the outstanding sales organization we have in internationally.

So, like you said, we continue to feel very encouraged about the results but we’ll see kind of where the train continues to go. But I would say that, I think the biggest driver obviously aside from continued execution is the impact clearly that this clinical evidence is happening.

And the ability as we highlighted to actually be able to deliver on the promise of those outcomes in clinical practice every day..

Mike Weinstein

Rami, I’m going to ask one last question, I apologize I’m going to let some others jump in queue. But the established competitors, Medtronic, Boston and St. Jude, the one that I have felt as the kind of the best response or really kind of the only kind of real response at this point to Senza is St. Jude with Burst stimulation.

We’re going to see the SUNBurst data at NANS. And my expectation has been, is that data relative to historic tonic stimulation is going to look good based on all the data we’ve seen on Burst.

Can you just give us your thoughts on, there is not going to be at any point head-to-head study, it recently doesn’t look like a real one of Senza versus Burst, pacing from St. Jude.

Can you give us your thoughts on without having seen what SUNBurst is going to look like on how do you view Burst relative to HF10 therapy?.

Rami Elghandour

Yes, I mean, what we’ve said about Burst, I appreciate the question Mike, as Burst has been available internationally in a number of markets where we’ve been available. And I think our growth continues to speak for itself. So, without seeing the data there is really not a lot more that can I can comment on.

I believe that they do present data which hasn’t been 100% confirmed yet, hasn’t been confirmed yet. I believe it will be three months’ data on each arm. So, I think we’ll see what we can expect really in terms of outcomes from that sort of data set. But again, I think we rely on international experience there and our results there thus far..

Mike Weinstein

Thank you guys for taking all the questions..

Rami Elghandour

Thanks Mike..

Michael DeMane

Thank you, Mike..

Operator

The next question is from David Lewis with Morgan Stanley. Your line is open..

David Lewis

Good afternoon..

Michael DeMane

Hi David..

David Lewis

So, few quick questions here. The first is just thinking about the fourth quarter guidance. So by our math, the fourth quarter implies, your reps are already annualizing your 500,000 revenue per reps, that’s at least six months ahead of our model.

So, does that change Michael or Rami how you’re thinking about adding reps in ‘16? Or do we still assume you add materially to rep counts in ‘16?.

Michael DeMane

Well, look, I think like I said, we would provide our guidance on the number of reps, our hiring plans when we report the fourth quarter numbers. But as I think we’ve all alluded to, there is the strong demand for the therapy.

And as we’ve said from the get-go, one of the underpinnings of our launch strategy is to make sure we go to the right accounts, use it in the right patients and make sure that it is properly supported from us as a company. And that means having really talented skilled people in the field supporting the practices in the patients.

So, yes, I do think we are going to have to continue to add significantly to our headcount in the field. Certainly in the United States but also I would say internationally as well. And that is our plan..

David Lewis

Okay, helpful. And then, just two more questions here. Last week was a big survey week and in our survey last week, did show an interesting bias towards your product being used with the pain management anesthesia over the neurosurgeons.

And I wonder that doesn’t really surprise us necessarily but how is your experience across those physicians had differed? And could you give us an updated timeline for the paddle lead?.

Michael DeMane

So, Rami, why don’t you?.

Rami Elghandour

Sure. So, our experience as you know let me kind of step back.

So I think your question David is, how is our experience different between pain physician community versus the neurosurgeon community, is that right?.

David Lewis

You got it..

Rami Elghandour

Okay. So, our experience thus far has been consistently positive. We have been able to support neurosurgeons in the U.S. who are more familiar and are able to place percutaneously. So, it’s not, we have been able to work with that with some segment as a neurosurgeon community thus far until we have a paddle available in the U.S.

And I would say, our results and our experiences thus far have been positive across both physician groups. As far as the paddle lead timing, we haven’t announced that publicly. But we have acknowledged that we are working on and it’s one of our priority projects from an R&D perspective..

David Lewis

Okay. And then to Andrew, just maybe a last one here and I’ll jump back in queue. I was just thinking about guidance here. So, if we think about your fourth quarter momentum, and obviously you’re almost half way through the quarter, which makes it a little bit easier to assess revenue in the fourth quarter.

But you guidance for the fourth quarter is materially above the stream, perhaps it’s certainly more than necessary by many miles.

So, can you just give us a sense how you handicapped the holidays in the fourth quarter, Thanksgiving and Christmas as it kind of relates to establishing guidance and rep utilization for the fourth quarter? Congrats on the quarter. Thank you. That’s all I got..

Andrew Galligan

Yes, sure. So, there are actually two big differences going on here. One is, in the international market there is in fact a slowdown in December, of course Thanksgiving is irrelevant to them. So, that’s one trend that you find in the market. However, in the U.S.

market, December tends to be one of the larger months as people get to the end of their deductibles. And that is a major factor in the U.S. market presence. So, we did actually take those fully into account in coming up with our guidance numbers..

David Lewis

Okay. Thank you very much..

Michael DeMane

Thank you, David..

Operator

The next question is from Danielle Antalffy with Leerink Partners. Your line is open..

Puneet Souda

Yes, hi guys, this is Puneet in for Danielle. Thanks for taking our question. And congrats, this is absolutely a phenomenal quarter..

Michael DeMane

Thank you..

Puneet Souda

So, just couple of questions. In terms of, I mean, we were seeing early on we were seeing some warehousing. Are you still seeing that, I mean, you have clearly grown broadly in a lot of societies, into some of the regional societies, Florida, Texas and other California, so that even other places.

So I mean, are you still seeing the sort of warehousing effect? What are you hearing back from the physicians? Is there, patients that they have warehoused and now you’re seeing broadly or could you give us some color on that?.

Michael DeMane

So, clearly we do have some accounts that have warehoused patients in anticipation of our product.

But I would say that as we said from the very beginning, there is typically a, evaluate the product, utilize it, see how it works in that physician or the surgeon’s hands and see what the outcomes are before it’s really embraced in terms of fully integrating this into the practice.

As Rami mentioned in his comments, we are seeing earlier conversion - full conversion of accounts in the U.S. launch than we saw in our analogous international launch. But again, the difference maybe the fact that we have this level one data underpinning our product, it could be that.

And it could also be that there are those patients warehoused that are being kind of brought to there and we’re using the effect - therapy effectively to treat them. So, I think we’re seeing some of that, I wouldn’t say especially broad in the market. It’s on account by account basis..

Puneet Souda

Okay, thanks for that. And just in terms of the training wise, which accounts or what sort of folks are you still sort of getting a push back in terms of, clearly the learning curve is none to almost inexistent. So, as you are going into folks who are paresthesia mapping trained and they’ve done that through their career.

So, I mean, what sort of accounts are you still getting a push back, because this clearly looks like everyone is adopting.

But where are you getting this push back from?.

Michael DeMane

I’m going to ask Rami to fill that one.

Rami?.

Rami Elghandour

Sure. So, I mean, I think you made the comment to me everyone is adopting, that’s not - one full quarter into the U.S. launch. So, obviously things are going phenomenally well. But let’s not get ahead of ourselves. I would say there is work to be done right.

And any sort of launch and any sort of product whether it’s a medical device or technology, etcetera there is kind of a distribution of adoption attitudes and curves. And we’re certainly going through that where there are certainly a lot of early adopters. And we’re getting faster adoption as I said in those accounts.

And I think there is still a lot of work to be done to obviously drive broader adoption of the therapy into the large U.S. markets. So, I think that’s kind of what I would at a high level.

The competitive spin if you will are pushed back to get more specific, it’s nothing new, it’s the type of things that we’ve heard about in the past that’s feature and benefit selling around whether it’s size of IPG or MRI compatibility and things of that nature.

And we obviously stand behind their clinical evidence and the patient outcomes we’re able to deliver. That has been and continues to be the single most important driver of our business. At the end of the day, what’s driving the adoption in the U.S.

is the benefit that these physicians are seeing in their patients, the profound pain relief we’re able to deliver. And with that ability, we are generally very successful, have been and believe we’ll continue to be in terms of driving adoption therapy both in the U.S. and internationally..

Puneet Souda

Okay, thanks for that. And just one final one, and just in terms of as you go to NANS. Are you expecting any investigator led studies or are you expecting more single-center studies to come up in addition to the 24-month data? And that’s all I have..

Michael DeMane

Yes. So, if I understand your question correctly Puneet, we don’t expect to have publication or presentations on any investigator initiated studies at NANS. I think we have a pretty good window into what’s likely to be presented there and we don’t expect that..

Operator

The next question is from Dave Turkaly with JMP Securities. Your line is open..

Dave Turkaly

Hi, thanks. You mentioned in your prepared remarks that two or four key long-term studies. I was wondering if you guys are prepared to give us just a clinical update on, where you stand today..

Michael DeMane

I’m sorry, David, can you maybe rephrase that? I want to make sure I understand your question..

Dave Turkaly

I guess, to the extent that you can talk about some of the other indications you’re going at, I know you mentioned the feasibility study last quarter, we talked about some other indications in the past. I was wondering if you have any update on sort of where you stand on the clinical front today for other indications..

Michael DeMane

Got it, thanks for the question. So, really what we’re talking about is an asset company that always wants to have sound and solid clinical evidence underpinning what we do in the market.

The question is where do we go next vis-à-vis label expansion? And our label expansion efforts that we talked about in the last call were the upper limb and neck trial which was a feasibility trial in the United States. Now, this is a feasibility study only.

So, ultimately assuming that goes well, that would then go to a full-fledged pivotal trial and then to submission. So, we go through the whole process there that we’ve just gone through now on the back and leg pain indication.

Other areas that we’re keenly interested in, and have done work already in either single-centers or multiple centers outside the United States, would be refractory low-back pain that would be patients that are significantly disabled but they have not had spine surgery yet. So we’ve done a number of studies in that area.

Some of those are cohorts of the existing Senza pivotal study or the EU study that’s already been published. And we also have standalone work underway in the U.K. in that area.

And the other area where we’ve done our label expansion work we’ve done that we have spoken about publicly is some very preliminary, pilot work out of Europe in the area of migraine. And so, in each of these, of course these are label expansions that are still within the broad indication of pain relief but the location of the body is different.

And therefore it requires different lead placement, different programming algorithm and it necessitates we do the basic clinical workforce before we bring it to the market..

Dave Turkaly

I got you, thanks. And then, if we look at, so you’re U.S. rep base today, 92. I guess, is there a way to think about sort of an average account number broadly speaking, maybe even just anecdotally.

Like how many accounts do you think a fully trained rep can target?.

Michael DeMane

I think, I’m going to ask Rami to jump in here. I think we’ve actually covered this on the last call.

It is very difficult to do Dave because what you’ll find is, if the account is big enough, one single account can consume the time available for one really, really good and experienced representative conversely if they tend to be a little bit smaller, they might have two or three or even more.

And it also gets to the geography we’re talking about, are you in a rural area or is it a metropolitan area where you can get to several big hospitals quickly. So, with all those factors, it is difficult to come up with an average or likely case. And I think the only other thing I’d say Dave is to think back to our strategy for going after the market.

We are not particularly interested in skimming the market and going to multiple accounts and taking a little bit of business or some of the patient in many accounts rather given our belief in the therapy that it is superior and it can deliver better outcomes.

Our preference is to go deeper in a smaller number of accounts and really serve those accounts well, and serve those patients well. So, that’s kind of our general approach. And if you take that onboard you might say well, that should drive fewer, number of accounts per representative. But as I said earlier, it’s highly variable.

So, Rami, you got anything to add to that?.

Rami Elghandour

Yes, just maybe make one more point on that. Everything Michael said obviously perfectly highlights our strategy.

So I think when you take that to a level, how do I think about this business? The way to think about it in terms of, and why we chose to communicate rep productivity, that’s the way we think about our business and that’s the way we encourage folks to think about it.

It’s not reaching in terms of number of accounts but what type of volume can one rep manage. And what we’ve said again is $1.3 million to $1.5 million in 18 to 24 months. And as Michael said, we actually hope and while our strategy is to make that rep as efficient as possible being fewest number of accounts as possible to drive our business.

Because after a number, we’re actually growing the market in addition to taking shares.

So, if we are in an account and we can take significant shares from that account and grow that account significantly, that could keep a rep pretty busy versus having to go to three or five or eight accounts to get the same type of volume of business by skimming as Michael put it.

So, we have - we encourage folks to kind of think about our business that way in terms of productivity and because that’s how we built our business, it’s positioning as well supposed to really drive adoption and grow the accounts that we’re aiming and help treat a lot more patients in the process..

Dave Turkaly

I appreciate that detail. I guess, I’ll try one last way to get the same thing. And I do appreciate that answer. If the top 5% do about 30% of the volume, and that’s really a couple of hundred accounts.

If you had to guess today, how many of those do you think you’ve hit already, if you would just guess in sort of how many of those you’ve actually targeted or been in front of since the launch? Thanks a lot..

Michael DeMane

Sorry Dave, sorry to dodge that. But I think we’re going to stay pat on that one..

Dave Turkaly

Okay, thank you..

Michael DeMane

Appreciate it..

Operator

The next question is from Joanne Wuensch with BMO Capital. Your line is open..

Joanne Wuensch

Thank you, good evening. And very nice quarter..

Michael DeMane

Thank you, Joanne..

Joanne Wuensch

Two questions, the first one is your sales force hires.

Where are you getting these folks from and how long is it taking for them to get up to speed?.

Michael DeMane

So, we are taking our sales force hires from really all quarters. Some are actually coming directly from competitive SCS companies. Some come from competitive SCS companies with no, non-competes. Others come and we may have to change their territories.

We’re also hiring from other medical device companies where they may have familiarity with active implantable. But not spinal cord stimulation. So that has certainly been a pool we’ve hired from.

And there are some that are frankly at other medical devices companies that have not even done active implantable but they are very proven and effective sales individuals and professionals. And we pick them from that pool as well.

So, I would say really from all quarters and we’re quite pleased with the caliber and the professionalism of the people that we have right now undertaking the launch in the U.S. And of course the numbers show it. And the same is true internationally.

Now, in terms of productivity, we think, I think what you’re referring to is what does it really take to get to full productivity? We’re basically saying on the order of 18 months to 2 years to steady state full productivity. And we’ve been consistent with that.

And with the information we’ve received since the last quarterly call, I would say it is only reinforced that estimate that we have. We’re still very comfortable with that..

Joanne Wuensch

Okay. My second question has to do sort of hunting in the same direction as previous questions were. By our count, you had about 155 implants in the quarter.

How broadly spread is that or conversely how narrow is that in terms of the physician and/or hospitals that are performing those procedures?.

Michael DeMane

Yes. So, Joanne, again I think we’re very comfortable providing the information that we’re providing and that is the number of reps, productivity timing and kind of their steady state productivity. We think a rep ought to be at the 18 to 24-month period, at $1.3 million to $1.5 million.

And we think that’s kind of the triangulation that we’re comfortable giving out and really don’t want to give a whole lot more color in terms of how we’re spread out in accounts, simply because we don’t think it’s particularly necessary and there is the competitive element to that that we prefer to stay away from..

Joanne Wuensch

All right. You can’t blame a girl for crime. Thank you. And have a good evening..

Michael DeMane

Thank you, Joanne..

Operator

And we have no further questions at this time. I’ll turn the call back over to our presenters..

Michael DeMane

Thanks Chris. And thank you once again everyone for joining the call today. We appreciate your continued interest in Nevro. And we look forward to our next progress update. Have a good day..

Operator

Ladies and gentlemen, this concludes today’s conference call. You may now disconnect..

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