Hello. My name is Chris, and I will be your conference operator today. At this time, I would like to welcome everyone to Nevro Third Quarter 2023 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. [Ian Toll] (Ph) you may begin..

Good afternoon. And welcome to Nevro’s third quarter 2023 earnings conference call. With me today are Kevin Thornal, CEO and President; and Rod MacLeod, Chief Financial Officer. On today’s Kevin will discuss third quarter business results. And Rod will conclude with detailed financials and guidance before we open up the call for questions.

Please note, there are also slides available related to our Nevro’s third quarter performance on the Investor Relations website in the Events & Presentations section. Earlier today Nevro released its financial results for the third quarter ended September 30, 2023.

A copy of the earnings release is available on the Investor Relations section of Nevro website at nevro.com. This call is being broadcast live over the Internet to all interested parties on November 1, 2023 and an archived copy of this webcast will be available on Nevro’s Investor Relations website.

Before we begin, I would like to remind everyone that comments made on today’s call may include forward-looking statements within the meaning of the federal securities laws. Results could differ materially from those expressed or implied as a result of certain risks and uncertainties.

Please refer to Nevro’s SEC filings including its annual report on Form 10-K filed on February 21, 2023 for a detailed presentation of risks. The forward-looking statements in this call speak only as of today, and the company undertakes no obligation to update or revise any of these statements.

In addition, management will refer to adjusted EBITDA, a non-GAAP measure used to help investors understand Nevro’s ongoing business performance.

Non-GAAP adjusted EBITDA excludes interest, taxes and non-cash items such as stock-based compensation, depreciation and amortization, litigation-related expenses, certain litigation charges and credits and other adjustments, such as restructuring charges. Please refer to the GAAP to non-GAAP reconciliation tables within the earnings release.

And now, it is my pleasure to turn the call over to Kevin..

one, strengthen our physician relationships, two, increase our growth and three, accelerate our path to profitability.

There are many potential adds to our sales bag that we are currently evaluating to take advantage of the synergies with our best in class SCS therapy that will be accretive to our margin and growth, but we will be thoughtful as we explore opportunities and will only expand our capital if a potential target meets all of our criteria, we will be a disciplined buyer.

And finally, profit progress. We continue to invest in our Costa Rica manufacturing plant and have other initiatives ongoing as we drive towards profitability.

The manufacturing ramp at our Costa Rica plant is proceeding as 46% of our iQ volumes were manufactured in our Costa Rica plant in Q3, and we continue to evaluate our internal processes looking for additional ways to improve our operational efficiencies. Turning now to our third quarter results.

For the three months ending September 30, 2023, Nevro reported revenue of 103.9 million, an increase of 3% on both a reported and constant currency basis compared to prior year results. Our permanent procedure growth was 7% year-over-year and PDN had another strong quarter increasing revenue by 56% compared to last year.

In the third quarter, HFX iQ accounted for roughly 43% of our permanent implant procedures, up 1,300 basis points over the previous quarter and we expect this trend to continue.

The feedback for HFX iQ and its ability to deliver personalized pain relief continues to be very positive and we are confident that the combination of our superior high frequency, paresthesia-free SCS and our HFX algorithm will enable us to outpace our competitors.

While we believe we held share in new implants this quarter, we are obviously not content as it is our moral obligation to win for patients to receive the superior pain relief from the only high frequency SCS provider in the world.

Additionally, with three of the leading players having now reported growth for the quarter, we remain confident that the SCS market continues on the road to recovery and showing consistent growth. Turning now to our PDN business, PDN trials represented approximately 24% of our total U.S. trial volume, an increase of 41% from Q3 of last year.

Among our permanent implant procedures, PDN represented 20% of total worldwide procedures, resulting in approximately 21 million in PDN indication sales. In Q3, approximately 21% of our U.S. PDN trial procedures came from leads generated from our direct-to-consumer marketing program.

We believe that patient and physician education is imperative to drive awareness of the proven clinical benefits for patients that suffer from debilitating painful diabetic neuropathy. I would now like to say a few words about our updated guidance. First, while we exceeded our Q3 expectations, we know we can accelerate our top line growth.

We have made many changes to our marketing and commercial teams over the past several months and it will take time for these changes to translate into meaningful financial results. The positive enhancements we have driven in our culture over the last seven-months have been significant and we believe these changes will lead to a stronger Nevro.

We are confident in the direction of our company and look forward to executing our current strategies, driving growth and taking advantage of the meaningful leverage opportunities we have to drive towards profitability and deliver shareholder value.

Before turning the call over to Rod, I would like to briefly discuss our thoughts on GLP-1s and proactively explain why these therapies will not adversely impact our PDN business. There has been a lot of noise regarding how GLP-1s will affect the market for medical devices.

We acknowledge that these therapies can help many people with obesity lose weight and patients with diabetes lower their A1C. This is not our target patient population, however, and GLP-1s We are never intended to nor do they address PDN.

Many PDN patients have been using GLP-1s for years to control their glucose level and importantly, these drugs have never been shown to reduce the incidence of PDN or the severity of its symptoms.

In fact, a large number of patients that were included in our since the PDN study were already taking GLP-1s or similar types of drugs for years and unfortunately still suffered from painful diabetic neuropathy. These patients responded very well to our high frequency SCS therapy.

PDN is not simply a result of the patient’s A1C or their weight and even patients with normal BMI and controlled A1C levels experience PDN. We continue to believe that there remains a large addressable refractory PDN market around two million to three million patients and penetration rates are very low in that market today.

And with that, I will pass the call over to Rod to provide further details on our third quarter results and guidance..

Thanks, Kevin, and good afternoon. I will begin with our worldwide revenue for the third quarter of 2023, which increased 3% as reported and on a constant currency basis compared to the third quarter of 2022.

PDN represented 20% of permanent implant procedures worldwide resulting in approximately 21 million in PDN indication sales in the third quarter of 2023, this quarter included one less selling day than Q3 of 2022. U.S. revenue in the third quarter of 2023 was 89.8 million, an increase of 4% compared to the third quarter of 2022.

International revenue in the third quarter of 2023 was 14.1 million, down 2% as reported and down 6% on a constant currency basis. Now, moving on to some detail below the top line, gross margin was 66.9% in the third quarter of 2023 compared to 69% in the third quarter of 2022.

The full market release of the HFX iQ system continues to progress well and we are capturing a pricing uplift on our HFX iQ product. Our legacy products, which still represent over 50% of our mix, continue to experience pricing erosion.

This pricing pressure along with regulatory delays of selling iQ into Europe and the reduction in second half guidance on volumes continue to cause us to sell off our higher cost iQ product sourced from contract manufacturers.

We are still optimistic on our long run margin expansion opportunities with our Costa Rica sourced products assuming pricing remains stable. Looking at operating expenses, the total for the third quarter of 2023 was 95.1 million, compared to 92.2 million in the third quarter of 2022.

Excluding the 105 million of certain litigation credits in the third quarter of 2022. The increase in OpEx is primarily due to litigation and personnel related costs, partially offset by a decrease in stock based compensation.

Litigation related legal expenses were 4.3 million for the third quarter of 2023 compared to 1.9 million in the third quarter of 2022. Non-GAAP adjusted EBITDA for the third quarter of 2023 was a loss of 5.8 million, compared to a loss of 3.8 million in the third quarter of 2022.

Cash, cash equivalents and short-term investments totaled 320.3 million as of September 30, 2023. This represents a decrease during the third quarter of 2023 of 9.7 million. Uses of cash were in line with normal business operations as well as our projections.

We continue to manage our working capital and are very comfortable with our balance sheet to fund operations. Turning now to guidance, it is important to note that we will be using non-GAAP financial measures to describe our outlook for the business.

Please see the financial tables in our press release issued today for GAAP to non-GAAP reconciliations. We expect fourth quarter worldwide revenue of approximately 108 million to 110 million, which represents a decrease of 4% to 6% on a constant currency basis.

We expect fourth quarter of 2023 non-GAAP adjusted EBITDA to be a gain of approximately $1 million to $2 million. We expect worldwide revenue for full-year 2023 of approximately $417 million to $419 million, an increase of 3% over prior year on both an as reported and constant currency basis.

We expect full-year 2023 non-GAAP adjusted EBITDA to be in the range of negative $24 million to negative $25 million, which compares to a non-GAAP adjusted EBITDA loss of 23.8 million in 2022. In closing, we continue to make good progress and remain on track to drive growth and scale profitably in our core business in years ahead.

We are strategically positioned with best-in-class SCS technologies and with the changes we are making to our commercial and marketing functions, we expect to outpace our competitors and expand the overall market. Our strategic plan is in place and now it is time to execute it. That concludes our prepared remarks.

I will turn the call back over to Ian to moderate the Q&A session..

Thanks Rod. In order to get through the question queue efficiently and take as many questions as we can. We ask that you please limit yourself to one question and a brief related follow-up question. You can then rejoin the queue and if time allows, you will take additional questions. Operator, we are ready for Q&A instructions..

[Operator Instructions] Our first question is from Shagun Singh with RBC Capital. Your line is open..

I just wanted to touch on Q4 revenue guidance. It looks like it is slightly below consensus and it implies sales down 4% to 6%.

Should we view it as conservative since you have indicated that you would rather be on a trajectory to beat and raise and then also, what does the exit rate imply for 2024? Perhaps you can share more broadly with us your view of the SCS market recovery competition, uptake of PDN. If you can just help us frame 2024, that would be really helpful.

Thank you for taking the question. .

Yes. Thank you for the question there and I will take a crack at the first one, then I will hand it over to Rod for the second part. So for guidance, obviously there is a lot of things going on in the world from a macro level right now.

We are also still underway with our transition of Greg coming in and the changes in a commercial organization and so we want to make sure that we continue down and make the right decisions we need to for the business to set us up for the future. And so, those things play into our guidance for Q4.

Also, just thinking through from a competitive standpoint, we do now have three of us have now reported on SES and all three reported growth. Albeit a little bit lower, I’m from a couple of us in the low single digits and we will see what our 4th competitor or the 4th player in the market here in a few weeks will report.

And so, yes, we still feel confident on the recovery. We feel good that now this is multiple quarters where all four players have shown some growth or one quarter that one player didn’t, but pretty consistent growth now, but definitely not to the levels where we were prior to COVID, and so, that plays into that as well.

And I will turn it over to Rod to talk about exit rates and any other guidance..

Yes. Hi, Shagun. Thanks for the question. And then just to add a little bit on Q4, we have got our typical Q4 seasonality built in there, which is showing the sequential ramp up from Q3 into Q4 as well. We don’t normally, we are not providing guidance on 2024 at this point and we generally don’t get, so granular to provide exit rates.

Kevin spoke generally about where the market has been performing over the last three quarters and we remain optimistic that that sort of growth is trending in the right direction. But beyond that, there is not a whole lot more color in terms of, what our exit rate will be going into next year. .

The next question is from Anthony Petrone with Mizuho Securities..

Just one follow-up here kind of on the 4Q guide. This is Brad by the way on for Anthony.

Just looking at, I guess, what you are kind of implying from the core business, it seems the trend we are looking at in the fourth quarter, at least per guidance is actually one of the worst, I guess, core quarters since the back half of 2021, I guess, when we first saw, never revenue kind of falling in the core business.

So just kind of wanted to hear what thought process was on that trend? What you are seeing, I guess, within the core business out these practices?.

Again to start off the macro environment, right. I mean, we have got two wars going on right now, and I’m watching all of my colleagues at other medical device companies, what they are saying right now. And so, obviously, want to make sure in this environment that we are thinking through anything that could happen from a macro trend level.

As far as the core market itself, again, we posted a 3% growth. One of our competitors was probably 2% to 3% growth in the core market, and then one had an outlier replacement of batteries, and that is not new patients as we talked through.

So, we are a little bit cautiously optimistic about the market returning back to where it was before but, obviously, with this macro environment, overhang. It is a little bit, affecting capital markets probably more than it would for implants, but we also wanted to be a little bit cautious, with what is going on in the world.

Rod, anything to add there?.

Yes. Just one thing to reiterate is that, we are still early in the changes on the commercial side of the business. We do have to give them a little bit of time to implement and give them a little bit of time and room to maneuver the way. They think it is the right to set us up for 2024 and beyond..

Yes. I will add just to add into that, Rod. We had two of our largest training classes ever come through here in Redwood City, over the last quarter. So, those reps are getting out in the field, coming back in for additional training, and then getting back out in the field to, being able to get out there and do what salespeople do best..

And then just one quick follow-up here. You now have, I guess, all of the competitors in the PDN market, with the final one getting their approval recently. So just wanted to give you the opportunity, now we don’t have to worry about what is going to happen once those competitors are in the market.

So how the conversations are going with the PDN sales force and how Nevro is continuing to win those conversations? And thanks again for taking the questions..

We are still the only paresthesia-free SCS player on the market, the only high frequency on the market.

And as we have said all along, and it resonates with the endocrinologists that refer patients in to our implanting physicians, and it makes sense to our implanting physicians that you would desire a paresthesia-free option for patients that are already experiencing numbness in their feet and their legs.

Why would you want to add even more to that? So the whole goal is to get up is to get people pain free and up and ambulating, so they can walk around.

And when they walk around, obviously, then they are going to have better results and lowering their A1C and their body weight, which we have now data showing that the implanted, patients with SES 10 kilohertz high frequency do reduce weight in A1C.

And that is because, obviously, we don’t know for sure the method of action, but we do know those patients get up and walk around, and we do have clinical results showing they do better. No one else has that kind of clinical data, and no one else can do paresthesia-free high frequency.

So, we still feel very optimistic that we are going to continue to win there. Now, I will also say that in any type of medical devices that I have been in for, well over 20 years, all companies do well when rising tides happen for all.

So I do think that having more players in the market to help educate and to have increased the awareness is good for patients and good for implanting physicians as well..

The next question is from William Plovanic with Canaccord Genuity..

This is [indiscernible] on for Bill Plovanic. Congrats on the quarter.

Just wondering more broadly to what extent you are seeing increased competition and share gains or losses from the private competitors in the market?.

Yes. We are really not seeing that much. We do look at a couple of the models that are out there. We do see some of the expected results that are there. We obviously still are the only high frequency player in the market.

I do believe that they are probably going after some of the other low frequency competitors that are out there, and we continue on our path of explaining and using the clinical studies that we have to show the superiority of the paresthesia-free high frequency SCS. So, we are not thinking that we are losing share to any of those smaller players.

And obviously, it doesn’t mean we are not losing a few cases here or there, but we believe we held share in the quarter. .

The next question is from Adam Maeder with Piper Sandler. .

This is Simran on for Adam. Thank you guys for taking the questions. I just wanted to start off on a comment that you guys made on the HFX iQ launch. I think you said iQ represented 43% of implants in Q3. We are now over 6 months into the iQ launch.

And I think previously, the team had said it would take six to nine-months for the launch to represent 75% to 80% of the mix. So just any further color on how that launch has relative to your expectations.

Any learnings that you can share from reps in the field?.

Yes. Hi, Simran, this is Rod. Yes. So we are a touch behind the curve where we would have thought that we be at this point. And there have been a couple of things that have impacted the launch, although we still continue to see a trajectory that is going up and to the right.

But you know, as we have mentioned before, we did, as Kevin just mentioned, we had a large training class. We had some open territories. And we are making the changes within the sales force to bring them up to speed, get the new folks trained. That probably had a little bit of an impact there.

Some of the larger contracts, it took us a little bit longer to get on contract with those, but we had some pretty good successes in Q3 that we should start to see some of the results of that. And then we also thought that we would be selling iQ internationally with BSI approval.

And we are, I think we are not the only ones in saying that we have had experienced some delays out of BSI on that. But that certainly delayed that entering into the mix as well in terms of the iQ launch. But those are some of the bigger areas that have maybe slowed it down a little bit from where we thought we would be.

But as I said, we are still continuing to go up that ramp. .

And just a quick follow-up on the initiatives that you guys have implemented regarding the salesforce.

I guess I just want to fully understand, are those initiative completely implemented and digested, or do you still have some open territories here and there, that you kind of need to right size? And then how should we think about the salesforce over the remainder of the year and in 2024 in terms of size and productivity?.

Yes, pretty much, thanks for those questions. Pretty much the open territories are 1b2s at this point. We filled most of those, the last couple of quarters. And as I said, they have been in and out of their training courses that have been here. So that is good. The implementation and the enhancement of the comp plan is all done.

The reps have the numbers that they are marching towards has finish up the year, as we head into the end of the year. And obviously, we will continue to tweak everything, as we head into 2024, but in large, everything, that was the big initiatives are behind us and absorbed and the team is running hard out in the field. .

The next question is from Robbie Marcus with JPMorgan. Your line is open..

This is actually [indiscernible] on for Robbie.

Just a question on gross margin, it came in a bit softer in the quarter, and I was hoping you could just talk more about your expectations for fourth quarter in light of the HFX ramp and what a reasonable assumption is for margin expansion next year and longer term given all the puts and takes from the legacy pricing, HFX and Costa Rica?.

This is Rod. You are hitting the two big things. We have a confluence of an iQ launch and a transfer of manufacturing to Costa Rica. And as we have talked about in the past, as iQ ramps, we also have pricing pressure on our legacy products. And in Q3, legacy products still represented over 50% of our mix.

And as we have reported over the last couple of quarters and continuing into this quarter, continue to have some pricing pressure there. Similarly, as we are a little bit behind that curve as we answered in one of the previous questions and don’t have that BSI approval to sell in the Europe.

Our volumes a little bit are a little bit lower, which also means we have to continue to sell-through contract manufactured products at a higher rate than we would have anticipated. So we kind of have the confluence of those two things happening in Q3, which obviously put some pressures on the margins as you noted.

We should get better going into Q4, our mix on iQ will improve. We will have to sell some of our contract manufactured products in Q4, but over time, we do transitioning more and more to the Costa Rica towards products, and now that will certainly help margins.

I would anticipate that, for 2022, we are not providing guidance for 2024, but we do expect that over time, we have a pathway still to kind of that mid-70s that we have talked about. It just could take a little bit of time, in terms of us getting there both from a cost and a price perspective..

I just had a quick follow-up on PDN, and apologies if someone may have already touched on this.

But are you seeing any competitive pressures here specifically? And do you have any thoughts qualitative on 2024, and your expectations for the market as well as competition next year?.

Yes. So we did answer the PDN 1, but I will just wrap it up again. Yes. We do know that, all of our competitors have indications. However, that is obviously FDA approval.

You still need to have clinical studies to show the doctors to convince them, to try that, and that is continually where we are the only company that has the large RCT, that is out there that shows the benefits of high frequency paresthesia-free.

And like I said, just earlier before, why would you want to put a patient into paresthesia, who is already experiencing numbness and tingling in their legs? So we feel very confident about our leadership there in PDN, and we talk about it every day.

And I use the word moral obligation other words, moral obligation, because we know when we win, that means patients get the best therapy that is been clinically proven in the PDN space. So we feel good that we will continue to maintain our leadership there.

We are - it is a benefit to have other competitors in the space, because all those rise with the rising tide, of course. So, that will help from an education standpoint. And on 2024, we are a month into Q4. So, we need to get a few more months underneath our belt in the transition with our commercial teams before we provide anything for 2024.

So, we are not going to provide any guidance at this time..

The next question is from Richard Newitter with Truist Securities. .

This is [Sam] (Ph) on for Rich. Just one just to follow-up on gross margin there. And I know we are not going to provide guidance for 2024, yes. But just directionally, is there any way you could speak to with all those moving parts going forward and hopefully getting resolved.

Should 2024 on a quarter to quarter basis see better gross margin than 4Q? Can 4Q basically be a taking off point for gross margin next year?.

Yes. Appreciate the question but like I said, we are not providing guidance into 2024 for the full-year, let alone for quarters at this point. What I will say though is that we continue to be excited about the costs that are coming out of our Costa Rica plant.

And we believe that we have got a good pathway to continue to drive those costs down and that should help with margins. And as we do move forward, we anticipate that we will receive pricing benefit from our iQ product as that mix increases.

So, not going to get a whole lot more granular than that at this point, but that is the sort of color that we can provide at this time. .

And then just more qualitative one, just as we think about maybe some of the regions where the commercial structure was more just realigned as opposed to having turnover and the salesforce, can you give us any color as to what the performance in 3Q looked like for those regions versus some of the ones where there was more disruption?.

Yes, I don’t think we will get into territory by territory, but I will just say in general, we feel really great about bringing Greg in and ensuring that we have A plus talent at every single position, whether that is someone who has been here for 10 years or 10-days. The expectations for our sales organization is extremely high.

The bar to get in is extremely high. And once here, the expectations continue to be extremely high. And so, a typical turnover in med device that is highly competitive, it would be 10% to 20%, and we definitely were in that range previously.

With our enhanced comp plan, with the alignment of the teams that we have closer to the customer working together with the management responsibilities occurring closer to the customer and giving power to those that are closest to the customer, we are seeing, not only pockets, but obviously, our expectations for this quarter, we did better than what we would have thought.

So, while we are not declaring victory, I do like where we are going. We have another quarter here that is absorbing some of these changes, but I feel good about Greg and his team and what they have done to be able to set us up for success, not only for this quarter, but also, really as we head into 2024..

There are no further questions at this time. I will turn it back to the presenters. My apologies. We do have one more question from David Turkaly with JMP Securities..

Kevin, I might just want to press a little bit on the M&A side.

Do you think you could stay focused on in the core pain markets or are you open to other areas, let’s say, in the neuromod or bioelectronic medicine arena?.

As I alluded to in the prepared remarks, the biggest asset we have in this organization, outside of our technology, our biggest expenses is our sales force. And what we want to do is ensure that we keep them focused on the same call points where they are headed today.

The last thing we wanted to do is add more places they have go to new doctors they don’t already know. So the focus has been on dropping something into the bag that they can leverage those relationships they already have. And spend more time in each of those locations before getting in the car and spending windshield time between the next position.

I would just say a little bit more clearly, what would be great is, each of our sales reps, when they show up at a physician’s office in the morning, can I look at the staff and say, boy, this is going to be a great morning.

I will be with you all morning doing X, Y, Z procedures with you, and then we will have lunch and then I will head on to the next place versus bouncing from 1 SCS case to another, doctor to doctor, right? I mean, our sales force, whenever they are in front of a windshield, they are not in front of a customer, in front of a patient.

And so, leveraging the sales force and dropping something to the call point they already have, it is the number one priority and the targets that we are looking at..

And one quick follow-up on the GLP. It sounds like you literally said that you expect zero impact and that I think I heard that, and that many of your patients in the trial were already on it.

I mean, is that like half or could you just provide like a percent there? And did I hear that correctly?.

Yes. So, yes, I will provide. It is about a third, a little less than a third of the patients in the PDN study were already on GLP-1s, or the class of drugs. And so, they obviously have been on those for years. I mean, it is not a new drug.

So they have been on those for years and they still met the inclusion criteria that meant they had painful diabetic neuropathy despite taking those drugs. So, that is what gives us the confidence. And then, I will reiterate in the prepared remarks as well, I mean, we are very in the very, very early innings.

We are probably still in batting practice in the full launch of PDN with two million to three million patients. And obviously, you can do the math. I mean, we are very, very little penetration. So see, even if a big portion of that market happened to go away. We were still well within our ability to grow for a really long period of time.

But the confidence is not only, the patients who are already in our PDN study that still had the benefit and had great results. But also, we obviously talked with some of the top leading endocrinologists in the world that are part of our KOL, key opinion leader group.

And so we take the guidance from them as well because they are the experts to see the patients every day..

The next question is from Rich Newitter with Truist. Your line is open. Okay. It appears that there are no further questions. I will turn it back to the presenters for any closing remarks..

Alright. Thank you, operator. Appreciate it. And thanks everyone for joining us today, and I look forward to reporting on our progress on our next call. Talk to everyone soon. Thank you..

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