Nevro Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 6, 2024

There are 11 speakers on the call.

Operator

Good afternoon. My name is Mark, and I will be your conference operator today. At this time, I would like to welcome everyone to Nevro Corp. 2nd Quarter 2024 Earnings Conference Call and Webcast. Today's conference is being recorded.

Operator

All lines have been placed on mute to prevent any background noise. After the speaker remarks, there will be a question and answer session. I will now turn the conference call over to Angie McCabe, Nevro's Vice President of Investor Relations and Corporate Communications. Ms. McCabe, please go ahead.

Speaker 1

Thank you, Mark. Good afternoon and welcome to Nevro's Q2 2024 Earnings Conference Call. With me today are Kevin Thornle, our CEO and President and Rod MacLeod, our Chief Financial Officer. Before we get started, please note that our earnings release and the supplemental presentation accompanying this call are available on the Events and Presentations page of the Investors section of our corporate website atnevro.com. Also, this call is being broadcast live over the Internet to all interested parties and an archived copy of this webcast will be available in the Investors section of our corporate website shortly after the conclusion of this call.

Speaker 1

I'd like to remind everyone that comments made on today's call may include forward looking statements within the meaning of federal securities laws. Results could differ materially from those expressed or implied as a result of certain risks and uncertainties. Please refer to Navarro's SEC filings, including its annual report on Form 10 ks filed on February 23, 2024 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 our ongoing business performance.

Speaker 1

Non GAAP adjusted EBITDA excludes interest, taxes and non cash items such as stock based compensation and depreciation and amortization, as well as litigation related expenses, restructuring and supplier contract renegotiation charges and other adjustments. Please refer to the financial tables in our press release issued today for reconciliations of GAAP to non GAAP reconciliation financial measures. I'll now turn the call over to Kevin. Kevin?

Speaker 2

Thank you, Angie, and thank you all for joining us. After the close of market today, we issued our Q2 2024 financial results. In my remarks today, I'll discuss the key factors that impacted our results and why we are revising our full year 2024 guidance, share why we remain optimistic about our business and discuss the initiation of our review of strategic opportunities. Rod will then provide details on our 2nd quarter financial results and 3rd quarter and full year 2024 guidance. To begin, our results for the Q2 of 2024 as compared with the Q2 of 2023 were as follows: worldwide revenue of 104,200,000 dollars decreased 4.3% on a reported basis and U.

Speaker 2

S. Revenue of $90,700,000 decreased 2.4%. U. S. Spinal cord stimulation or SCS trial procedures declined approximately 9.5%.

Speaker 2

Net loss from operations was $25,100,000 compared with $25,600,000 last year and adjusted EBITDA was positive $3,000,000 compared with a loss of $3,100,000 in the year ago quarter, demonstrating that our drive to profitability is having an impact on our income statement. And we ended the quarter with over $270,000,000 in cash and investments on our balance sheet, we're excited to utilize to fund our organic growth initiatives over the coming years. Last year, Nevro's board hired me as CEO to implement a 3 pillar strategy of commercial execution, market penetration and profit progress to address the challenges of softness in the de novo spinal cord stimulation market. We have made progress in many areas and we recognize that we have more work to do. Nonetheless, our revenue and trialing results in the quarter were impacted by competitive dynamics and continued softness in the U.

Speaker 2

S. SCS market. And this is also why we are revising our full year 2024 guidance. Importantly, we are taking proactive steps to improve our competitive positioning and we have long term plans to continue to diversify the business beyond SCS. The SCS market has seen increased competition driven mainly by new product launches over the past year by 2 of our larger competitors.

Speaker 2

As we've seen historically, some physicians like to try new products when they are introduced. However, we've found that physicians that use a multitude of products often revert to our patented 10 kilohertz therapy given our superior clinical data, ease of implantation and positive outcomes for more than 115,000 patients worldwide. Additionally, while we are confident that we continue to have best in class therapy for SCS patients, some healthcare providers also find value partnering with companies that can offer a diverse portfolio of products that treat and diagnose a broader spectrum of the patients. This is one of the reasons why last year we implemented our strategic pillar that includes diversifying our business to adjacent markets. As an example, we acquired a sacroiliac joint fusion or SI joint business late last year to give our customers more tools to treat patients suffering from chronic mechanical back pain.

Speaker 2

1 of the key advantages of this strategy is it gives us the ability to leverage one of our largest and most important assets, our sales force to drive adoption of and penetration into more therapies with our customers. Despite these factors, we still need to step up our execution, meet our expectations of capturing market share. Last year, we made several changes through our commercial realignment and have more work to do. For example, one of the elements of our commercial execution pillar is building a strong bench on our commercial teams. To further develop a high performing flexible field team, we have been developing our associate sales reps or ASRs and some are now ready to take on their own territories.

Speaker 2

And by deploying some of these existing team members into newly created territories, our sales team can reach more customers, go deeper with physicians, provide the service our customers expect and lay the foundation for new product introductions to the market. Also, in our continuous effort to improve commercial execution, we promoted some of our strongest performing field team members into leadership positions. Executing our strategy is paramount to driving long term profitable growth and we believe these changes will drive improved performance in the field. And when combined with our expanding product portfolio will help position us to compete more effectively and win in the market. Turning now to a discussion of the U.

Speaker 2

S. SCS market. The overall opportunity to treat patients who can benefit from SCS therapy is significant and continues to be underpenetrated. However, as we've discussed in the past, we continue to see softness in this market today. As we routinely do, we recently conducted comprehensive market analyses, including customer and patient focus groups and surveys.

Speaker 2

The results show that newer treatment options earlier in the care pathway ahead of SCS therapy are gaining traction. We believe these newer therapies are in some cases delaying patients from getting SCS therapy as well as competing for our customers' time and operating These newer procedures such as SI Joint Fusion offer physicians who treat patients suffering from multiple causes of chronic pain, more tools than ever before to treat their patients' pain and in some cases, their underlying functional, etiologies. Chronic pain patients have always progressed through multiple treatment modalities before arriving at the need for SCS therapy. And we believe more tools in the hands of our customers, while temporarily delaying the application of SCS in some cases, we'll continue to bring more patients into the care of pain management specialists and will ultimately expand the market for SCS therapy. We've seen this happen in other specialties and interventional markets.

Speaker 2

This increase in therapeutic options benefit both patients and the physicians we currently serve and is one of the primary reasons why we are diversifying our product portfolio to include treatment therapies earlier in the care continuum. Our acquisition of Versa Technologies, which gave us entry into the SI joint space is one example of this. Another strategic response to this trend that we have discussed previously lies in our solid R and D pipeline. It not only includes our next generation of high frequency SCS therapies, one of which we anticipate launching in early 2026 backed by strong clinical evidence, but also new devices and treatments that address additional causes of chronic pain. Nevro is more than just an SCS company today.

Speaker 2

Our vision is to free patients from the burden of chronic pain and we are working towards becoming a more comprehensive pain management company. While the opportunities for rapid SCS growth are currently slower than historic norms, the opportunities within the pain treatment space are more numerous than ever. As more procedures become less invasive, we believe that physicians who treat patients for chronic pain will continue to grow their practice and have the ability to treat a multitude of different pain conditions. We also believe that many patients who undergo these alternative therapies will ultimately continue the journey along the care pathway all the way through to SES therapy. However, we believe that by diversifying our business, we can better position we'll be better positioned as a unique resource to our customers and that can drive sustainable growth, profitability and value creation.

Speaker 2

Taking these competitive and market dynamics into account, we remain very optimistic about our business over the longer term given the multiple catalysts that we believe can contribute to our top line growth. As part of our plan to become a more comprehensive pain management company and drive market penetration of very large and underserved markets over the next few years, we are working on growing our business through expanded SCS indications, next generation SCS therapy and alternative therapies that are earlier in the care continuum. And as we continue to ramp our SI joint fusion business, we expect it to contribute more meaningfully to our growth next year. The painful diabetic neuropathy market, which Nevro created, remains underpenetrated at less than 1%. We continue to focus on this business by educating referring physicians and raising patient awareness benefits of SCS as treatment therapy for these patients and sharing strong clinical evidence of greater than 90% pain responder rates at 2 years and neurological improvement in the majority of subjects.

Speaker 2

We recently presented our 4 year follow-up with continued robust long term outcomes. In addition, as we announced last quarter, due to enrollment progressing more quickly than it expected in the Sensorsensory RCT, we reached the preplanned interim analysis and positive enrollment to allow the currently all randomized cohort to progress to the primary endpoint. This may allow earlier than initially anticipated publication, followed by potential review and specific inclusion of Nevro's proprietary 10 kilohertz SCS therapy into evidence based guidelines

Speaker 3

such

Speaker 2

as those published by the American Diabetes Association. We anticipate a readout from the interim analysis in early 2025. Also, as we discussed on our Q1 2024 earnings call, our SCS devices have rechargeable batteries with a very long functional life, yet they will eventually need to be replaced, as has been the case with our competitors for decades. We believe many of our patients will want to continue using our best in class and clinically proven high frequency therapy and access our newer AI enabled HFX IQ system, which uses real time patient data to enable on demand therapy adjustments and proactive care within 48 hours. As a reminder, we began treating a significant number of patients commercially in late 2015, which means patients implanted with our IPG during that time are now nearing the natural life of their IPG battery and many of those patients in consultation with their doctors will choose to replace their device with a new one.

Speaker 2

As I previously mentioned, our longer term goal is to become the leading provider of treatment options with the most diversified, differentiated and innovative product portfolio in the pain management space. By achieving this goal, we believe we can create the type of scale, growth, operating leverage and sustainability to unlock the kind of shareholder value that our Board and management team are intent on creating. But we feel an urgency to respond to this evolving market environment and to create value for our shareholders. So to enable and accelerate this strategy, our Board of Directors and management team have begun a process to explore all possible strategic options that might be available to us. We have retained advisors and over the next several months, we will more aggressively explore broader options alongside our current standalone path that may help us accelerate the achievement of our goals.

Speaker 2

These opportunities may include, but are not limited to partnerships, mergers or even a sale of the company. We have not set a timetable for the conclusion of this process and we can't say for certain that this process will result in our entering into or completing any transaction at all or that any transaction we identify will be a better option than our current standalone strategy. In the meantime, we remain laser focused on executing our initiatives. Over the past year, we have made significant progress on our 3 pillar strategy. We continue to focus on improving our commercial execution, which is still ongoing.

Speaker 2

We acquired an SI joint company that allowed us to expand into an adjacent pain market that is earlier in the care continuum. We aligned our cost structure more closely with the size of our business and we strengthened our balance sheet through our November 2023 debt refinancing. Before I turn over the call to Rod, I want to make very clear to our customers, patients and employees that we are in a strong financial position with over $270,000,000 in cash and investments on our balance sheet. We remain confident in the long term health and growth of our markets, our ability to compete and win in those markets and our ability to bring additional innovative products to our customers who treat patients suffering from chronic pain. Our more than 400 person customer facing teams remains dedicated to partnering with our physicians to provide exceptional patient care.

Speaker 2

I'll now turn the call over to Rod for a discussion of our Q2 financial results and guidance. Rod?

Speaker 3

Thanks, Kevin, and good afternoon, everyone. To echo Kevin's comments, we are pulling levers to better execute in the field and further position Nevro for the significant growth ahead while embarking on a process aimed at accelerating our growth, diversifying our business and creating shareholder value. For the Q2 of 2024 and compared with the year ago period, worldwide revenue decreased 4.3% as reported and 4.2% on a constant currency basis. U. S.

Speaker 3

Trial procedures decreased approximately 9.5% mainly due to competitive pressures and ongoing softness in the core U. S. SCS market in Q2 of 20 24. U. S.

Speaker 3

Revenue decreased 2.4 percent to $90,700,000 primarily due to the aforementioned factors and international revenue of $13,500,000 decreased 15% as reported and 14.5% on a constant currency basis. Our international business was affected primarily by the short term impact of negative SCS related media reports in Australia where we had the largest market share and that resulted in cases being postponed or canceled as well as the impact of healthcare reform in Germany that caused a delay in procedures in the current near quarter. Gross profit of $67,500,000 decreased 9.4% compared with the Q2 of last year, representing a gross margin of 64.8%. Note that Q2 twenty twenty four margins included a $6,000,000 one time charge related to the renegotiation of a supplier contract to reduce future purchase commitments and free up future cash flow as we continue to move our manufacturing processes to our Costa Rica facility. Excluding this charge, gross profit in Q2 'twenty four would have been $73,500,000 representing a gross margin of 70.5 percent, which we are very pleased with.

Speaker 3

This is compared with the gross margin in the Q2 of 2023 of 68.4%. Furthermore, in addition to our continued progress in rightsizing our contract manufacturing footprint, we also continued in the Q2 to make progress shifting additional work to Costa Rica to further leverage our investment there. It is through these types of actions and initiatives that we remain focused on and excited about achieving a long term gross margin in the mid-70s. Operating expenses decreased to $92,600,000 compared with $100,100,000 in the prior year quarter and includes a $4,600,000 charge related to our May 2024 restructuring as well as $1,700,000 in intangible amortization and contingent consideration revaluations related to our November 2023 acquisition of Versa Technologies. These are offset by a $4,100,000 reduction in litigation related expenses that was primarily the result of the Q2 'twenty four resolution of our legal dispute with the Mayo Clinic and Flathead Partners.

Speaker 3

Excluding the above items, OpEx was $90,400,000 in the 2nd quarter, reflecting a $9,700,000 year over year improvement, primarily attributable to our January May 2024 restructurings and continued focus on expense management and operational efficiencies. Cash, cash equivalents and short term investments were $273,700,000 at June 30, 2024, decreasing $7,800,000 from March 31, 2024, primarily due to cash used in operations. Turning now to our 2024 full year and Q3 guidance. Given our results in Q2 2024 and our outlook for the remainder of this year, both of which reflect the impact of the market headwinds Kevin discussed in his remarks, we are revising our full year 2024 worldwide revenue to a range of approximately $400,000,000 to $405,000,000 from our previous range of $435,000,000 to $445,000,000 representing an approximately 5% to 6% decrease from our worldwide revenue for the full year 2023. While we are quickly making changes to our commercial team and optimizing our sales territories, we don't anticipate feeling the benefit from these actions until we enter 2025.

Speaker 3

Therefore, our full year 2024 revenue guidance assumes that U. S. SCS trialing growth rates do not improve from the Q2 of 2024. We expect full year gross margin to be approximately 66% or 68% excluding the $6,000,000 supplier charge in Q2 that I discussed before. We continue to see our Costa Rica manufacturing facility produce excellent results with labor and material costs meeting our expectations for manufactured products.

Speaker 3

As I mentioned earlier in my remarks, we continue to project long term gross margins in the mid-70s assuming pricing holds at current levels. Also, as we previously communicated on our Q1 earnings call, we anticipate some second half gross margin headwinds due to the accounting of inventory variances that occurred in the second half of twenty twenty three as we are transitioning from a heavy reliance on contract manufacturing to bringing manufacturing in house. Therefore, gross margin in the second half of twenty twenty four will be lower than what the business delivered in the first half of this year. We expect our full year 2024 operating expenses to be approximately $383,000,000 down $6,400,000 from 2023. Note that our 2024 operating expenses also include restructuring related charges of 10,100,000 dollars Versa related amortization and milestone revaluations totaling $9,400,000 and key investments in our SI joint business as we continue to scale this business.

Speaker 3

Excluding the aforementioned items, we expect our operating expenses to be down more than 8% on a year over year basis. As we communicated on our Q1 2024 earnings call, we expect our restructuring efforts in the first half of twenty twenty four to generate savings of more than $25,000,000 in 2024 and full year annualized run rate savings of well over $30,000,000 We remain laser focused on maintaining a cost structure aligned with the size of our business and continue to look for additional efficiencies to drive margin improvement. We are also revising our full year EBITDA guidance as a result of our lowered revenue to a range of negative $20,000,000 to negative $18,000,000 from our previous guidance range of negative $5,000,000 to positive $2,000,000 While we aren't providing 2025 guidance at this time, as we look ahead to next year, we expect to reap the benefits from the changes to our commercial team and territories to drive growth and market penetration, continued ramping of our SI joint fusion business and greater revenue contributions from IPG replacements as we move throughout the year. For the Q3 of this year, we expect worldwide revenue to be in the range of approximately $92,000,000 to $94,000,000 which also assumes a U.

Speaker 3

S. SES trialing growth rate consistent with the Q2 of this year. We also expect Q3 2024 adjusted EBITDA to be in the range of negative $10,000,000 to negative 9,000,000 dollars In closing, while we made a lot of changes and accomplished much over the past year, we recognize that we have a lot of work ahead of us. We remain committed to executing our strategy to grow and diversify our business and getting us back on the path to profitability and value creation. Operator, we'll now open up the call for questions.

Operator

Your first question comes from the line of Nathan Trebek with Wells Fargo. Nathan, your line is now open.

Speaker 4

Hi. Thank you for taking the question. I guess, if we could just start with the strategic review that you announced. I guess, what are some of the options for you? I know you kind of walked through them on the call, but if you could just go into more detail on, are you looking for a merger or sale of

Speaker 2

the company?

Speaker 4

Can you talk about where you are in the process? And while I appreciate you're not providing potential timeline, but should we be thinking about some outcome of this process in 2024?

Speaker 2

Yes. Thanks, Nathan, for the question. As I said in the prepared remarks, we really like our strategy of diversification that allows us to bring more value to our customers and we could do that on a standalone basis. But we did feel the urgency to explore all possible options so that those can be available that might be able to help us accelerate those plans that we have for diversification and allow us to bring more value to our customers. So like you said, we're not given a timeline.

Speaker 2

We're in the early stages right now of the process and so we're just kicking off the exploration. And as we said as well, it may come down to the point of it might be best for us to be standalone if it doesn't bring as much shareholder value to explore these other options. But we're looking at all of them at this point.

Speaker 4

Okay. And in terms of your full year guide down, can you say, 1, how your PDN business is trending in Q2? And how much of that guide down is due to a lower outlook for PDN? And if you are moving share in PDN, can you just talk about why that is? Thank you.

Speaker 3

Yes, Nathan, this is Rod. We're not going into specifics of PDN. PDN continues to be a growth part of our business. So it's really in the more of the core market. And really what's driving our projection and our revised guidance here is just the trialing results that we saw.

Speaker 3

We're seeing some headwinds in the market, both from a competitive and overall market perspective. And looking at Q2, it seemed prudent to bring the guidance down into the range that we're talking about.

Speaker 4

Okay. Thank you.

Operator

Your next question comes from the line of Robbie Marcus with JPMorgan. Robbie, your line is now open.

Speaker 5

Great. Thanks for taking the questions. I wanted to ask on the knot guidance for 2025. It kind of sounds like you're talking about an improvement from trends, if I kind of read between the lines correctly. And just help me understand why things would improve, why fewer sales reps would drive better productivity in a market that quite frankly when I look at your peers is just not growing much.

Speaker 5

And based on the initial launch here with the SI joint asset isn't quite ramping as we had hoped. So why would 25 be better than

Speaker 6

24? Thanks.

Speaker 2

Yes, Robbie. And you said fewer reps. We said newer reps as we're expanding the territories with our assistant sales rep or associate sales rep program that we started putting in place last year and those reps are now a year in and we're feeling like a handful of those are ready to take on their own new territories, which allows us to go deeper and wider with the ever expanding portfolio into those customer accounts. So just want to make sure on that one. Look, as we finish the year of 2024, we are continuing to ramp our SI joint business.

Speaker 2

We continue to train physicians that are starting to build the SI joint business in their practice. Don't forget many of these procedures are done today by orthopedic and neuro spine surgeons and our pain management physicians and interventionalists are just now building this into the practice and a lot of their patients needed to go through the continuum of care earlier on to get failed injections and what have you to be ready for SI joint procedure, but we do see that growing month over month and we're progressing nicely there. We also think going into 2025, as we've made these changes at the end of last year and the ones we've just made as well, those will continue to take place to reunite the growth in the business. Look, we put in some people that have been successful here at Nevro despite some of these headwinds and are growing their businesses in the regions and their areas more rapidly. And those are people that are now in leadership positions that are leading other areas of the country.

Speaker 2

And then next year we also start to get in the beginning first end of our replacement cycle that happens naturally as patients talk with their doctors to talk about what happens with the end of life with their battery. And so those things are going to be tailwinds behind us as we enter 2025.

Speaker 5

Great. Maybe just a follow-up here.

Speaker 3

Still

Speaker 5

far away on my math from any kind of cash flow positive generation or meaningful cash flow generation, what's the plan to get there? How far out is it? And do you think with the current asset base, you can achieve meaningful cash flow, positive cash flow? Thanks a lot.

Speaker 3

Yes, Robbie, this is Rod. I'll take that. I mean, definitely by bringing the revenue number down that is going to delay our adjusted EBITDA, moving to the adjusted EBITDA positive land and as a result that will also delay when we think we cross over into that free generating positive cash flow. If you just look at Q2, we went through a little about $8,000,000 in operating negative operating cash flows. And we think that, with a little bit more revenue generation, we're actually not that far away from being able to break into that breakeven slightly positive cash flow land.

Speaker 3

But we do need a little bit more revenue to be able to create the cover for some of the fixed costs. So, not super far away, but obviously with the revenue come down, it pushes it out just a little bit. Thanks a lot.

Operator

Your next question comes from the line of Joanne Wuensch with Citi. Joanne, your line is now open.

Speaker 6

Hey, good afternoon, guys. This is Anthony on for Joanne. Thanks for taking the questions. I guess first just on the increased competition, could you dig a little bit more deeper into how you plan to address that just outside of hiring more people and getting more feet on the street?

Speaker 2

Yes, Anthony. So, yes, when we specifically were talking about 2 large competitors that had product launches over the last year. Obviously, when there's a new product launch in this space, go back in the historical charts there, you'll see that there's a big bump in those years when you get a new product launch really for two reasons. One is some of those splitter accounts that use multitude of products like to try the shiny new thing for a bit. But like I said in the prepared remarks, we've seen them revert back to the benefits of 10 kilohertz therapy over time.

Speaker 2

The other part about the launch that you see out there is that obviously there could be some pricing or other things that incentivize physicians to try those new products. They also have the benefit right now of people that were implanted over 10 years ago of their devices that are now up for reimplementation as well. And so they have a little bit more of the tailwinds when they launch a new product versus us. Up to this point, most of our revenue and our market share is de novo patients because we don't have that patient base yet, but we'll start to get in there next year for replacements. And so as we go out there to compete, our RCT studies and our clinical value and superiority in the labeling does give us something to always lean our hats on for us to remind physicians why they choose Nevro in the first place.

Speaker 2

The other benefit that we're starting to get into now, as a reminder, last quarter we talked about our SI joint business. We started out with our friendlies because we have limited trays and limited implants as we scaled up the manufacturing So we started off with some of our to go in and use

Speaker 6

on those early adopters, are they still going through sort of setting up their practice or are they now fully implanting the Versa portfolio?

Speaker 2

Yes, many of them are still setting up their practice and it's not really they have the tools they need to do it, but it's really getting their patients through the conservative management treatment that must be documented prior to getting approved by their insurance companies for final implants. But we are seeing early success for some of the top performing physicians in the training classes that are now starting to grow their business. You see them do 1 or 2 in the 1st month and now they're doubling and quadrupling in that on some occasions. And so we see the benefits there. We also continue to have heavy foot traffic into our training courses in Q2.

Speaker 2

So we're not going to give out the number, but it was many, many more than what we gave out last. And so that's continuing to build the funnel of physicians that are building their practice. And so we continue to have that physician base of a lot of people that have learned ready to start doing procedures. So it's a journey and it's a process to get them up and going, but we do see the results from those that have attended training classes. Great.

Speaker 2

Thank you.

Operator

Your next question comes from the line of Brandon Fazkaz with William Blair. Brandon, your line is now open.

Speaker 7

Hi, everyone. Thanks for taking the question. Kevin, maybe first, there's some talk of competitive headwinds and competitive pressures. I'd just be curious if you could opine a little bit on why you think some of the competitors are gaining a little bit of pocket share there. You guys clearly have a good product, in a relatively new product launch, plus you have a lot of good unique clinical data.

Speaker 7

So the question here is why are they gaining share in part to see what can you do about leveraging what is seemingly unique product and data set to stop that share loss or potentially even take share in the future?

Speaker 2

Yes. As I said earlier, you routinely see this in the SCS space. Again, go back and look at the historical charts and some of the revenue models that have been built up since 2012, you see when there's a new product launch, you see this big pop, you get price, you get new physicians that want to try something new for a little bit. And then again, you have that buildup of patients that have an older device by that company sort of ready for the next generation. And so you see a lot of interest of patients continuing that therapy, which is why we're excited when we get into those patients that are ready for their natural occurrence of a new product.

Speaker 2

The other thing that they've shown success doing, which is why we're diversifying our business as well, is they can leverage sort of a larger portfolio of products to be able to bring value to those customers. And we're still under 8 months of having the ability to bring additional products to build that value and we've concentrated more heavily on our friendly accounts right off the bat, But now we're going into those competitive accounts and using that same offense to get some of those cases. Okay.

Speaker 7

And maybe just a little bit on the P and L, just maybe you can talk to us a little bit about what does it take to kind of reach EBITDA profitability? I mean, guidance for the year has come down a little bit. Is this just simply a story of you need more volume over 400 mill, mid to high 400 mill to get EBITDA profitable? Or are there some efficiencies within this business model you think over time that you can leverage to become more profitable as well? Thanks for taking the questions.

Speaker 3

Yes. If you just go back to the guide from 90 days ago and we're at $435,000,000 to $445,000,000 we thought we could be in the adjusted EBITDA range of plus 2 to minus 5. So I'd say that that target range is kind of more in the mid-four 100s. And with the revenue dropping in the new guide then that obviously is going to drop through to the adjusted EBITDA. So I think that's the kind of that mid-four 100s is probably a pretty decent target.

Speaker 3

We are continuing to take leverage the P and L with some of our moves to leverage Costa Rica more and what we engaged in with some of our contract manufacturing and accelerating some of that move down to Costa Rica. Those will continue to provide some benefits, but it'll just take a little bit of time for that to work their way into the P and L. But as we operate and move going forward, we're going to obviously be trying to drive as much growth as we can and limiting the expense expansion in as aggressive ways as we can without affecting that top line.

Speaker 2

Yes. I just want to add on that one as well with our SI joint business. The benefits that we gained there is, it's actually increasing on our gross margin and we actually dropped it into the same sales force that we had. And while we're still ramping that business, each incremental dollar drops more to the bottom line than it's done before. And again, that plays out to our SCS as well as continuing line extensions and new technology for SCS therapy.

Speaker 2

And that allows us to be able to get that more leverage on our business and more drop through to the bottom line.

Operator

Your next question comes from the line of Anthony Petrone with Mizuho. Anthony, your line is now open.

Speaker 8

Thank you. Maybe a little bit more on the competitive dynamics in the quarter, stay on that topic a bit. Maybe just a little bit of detail on the pressures. You did mention the 2 existing large competitors. You also had mentioned in filing Saluda and BIOTRONIK sort of recently entered.

Speaker 8

So how much is coming from new entrants relative to the existing competitors? And when you think about just the dynamics at these accounts, is it a function of losing share at existing accounts? Or are we actually seeing Nevro exit some of these accounts due to competitive pressures? And then I'll have a quick follow-up.

Speaker 2

Yes. Yes. Mainly what we see is, in the larger competitors that have the same number, if not more of the sales people that are out there, plus they have a diversified bag, they get in and take some of those what we call splitter accounts, right? Those accounts that use us plus one other or maybe 2 others that are out there. And so when a new product launch happens, maybe we lose a few of the cases because they want to try it a little bit more while it's new.

Speaker 2

And we often see those reverting back to us. As far as some of the newer entrants, while we may lose cases here and there, they're not to the scale of our larger competitors. And so we often don't oftentimes don't run into them at some of our established accounts, specifically those that are the ones that are dealing with that love high frequency therapy. Going back to low frequency sometimes is difficult unless you have some kind of feature that could incentivize them to try it. And so we see more from the larger competitors than the new entrants.

Speaker 8

And then the follow-up would be just on operating expense allocation. And it sounds like between adding regions versus launching new products, the latter potentially would be more impact slippage situation. So maybe a little bit on the R and D initiatives. How long do you think it could be before a new core product in spinal cord stim is launched? Is there anything new on the PDN front?

Speaker 8

Are there new line extensions that we should expect, let's say, in the 2025 timeframe? And how do you balance that between the SG and A and R and D? Should we be flipping our models around to model a little bit more SG and A leverage and more R and D intensity? Thanks.

Speaker 2

Yes. Thanks, Anthony. Yes, with our territory expansions that we're talking about, these are people that have already been in our P and L and they're already on teams and learn from some of our best and they're now ready to take on some pieces of the territories that are already there. They're not going to have as big territories as some of our large established regions or territories that we have. But these are sort of up and coming less tenured reps that are happy to get a piece of dirt on their own and to prove it out that they can sell the entire bag.

Speaker 2

So that's number 1. So it's not like we're adding very expensive reps that maybe had been done in the past across this industry to grow. This is an offense that had worked at 2 previous organizations I worked in to grow from within as you build your bench. That's number 1. Number 2 is, our R and D pipeline and our expenses are ready, anticipate everything that we have in our pipeline today.

Speaker 2

You heard me mention in the prepared remarks, our next generation SCS therapy that is backed by science will be coming out in early 2026 and that's an exciting new platform that we think will be something new to the market and for competitive reasons. We've all talked much more about it, but it's our same engineers that were the ones who launched our revolutionary 10 kilohertz therapy in the past. And then as far as new products, right, we have SI joints that's already in the bag. And as I said last time, we had to go a little backwards before we went forward for two reasons. Number 1 is, it was mainly sold through distributors prior and these were distributorships that we needed to exit and then put that business back in the hands of our or into the hands of our own people.

Speaker 2

And so we went backwards before we were able to go forward. And also we were scaling up the manufacturing of both the trays that are needed for the procedures as well as the implant itself. And so now we've got that going from a scale perspective and we have more and more territories and regions every week booking cases for the first time or rebooking cases. And so as far as something new for PDN, as I mentioned in the prepared remarks, we are excited about this, RCT study that if we can get the power that we need by the interim results and it's blinded by us, so we don't have an early read, but we had some good indications that we might have the enrollment of what we need to be able to get a publication. And if we get a publication and it's our second RCT, that's the requirement that many of these societies need to be able to put you on any of their guidelines.

Speaker 2

And so that would be a big boost in our sales if that's a tailwind that occurs in 2025 also.

Speaker 3

Thank you.

Operator

Your next question comes from the line of Bill Plavonic with Canaccord. Bill, your line is now open.

Speaker 9

Great. Thanks for taking my questions. Good evening. Two questions really. The first is, can you help us just understand, as you've added Versa, we've seen kind of the core SCS slowdown even more.

Speaker 9

You talked about the PDN growing. I don't know how much Versa added to the quarter. But the more that adds, the more slowdown is core SES. How much of this is competitive? How much of this is Salesforce focus?

Speaker 9

They're selling Versa, they're not selling core SCS. How should we think about that? That's my first question.

Speaker 2

Yes. Thanks, Bill. One of the strategies that we laid out in the diversification was clearly we are not going to take our sales reps and put them into places which they're not already going today and with customers that aren't already or have the ability to do spinal cord stimulation. And as I talked about, our first customers right off the bat were our most loyal Nevro customers. And so if you think about a rep going to a location, doing a SCS case and then doing a SI joint case actually is more efficiency for them to be at one place to do 2 cases versus driving multiple times, hours behind a windshield, getting from place to place.

Speaker 2

And so it's not really focused that's driving, it's really those competitive pressures on the SCS space. And again, we're going to pivot and use our SI joint business, which has gotten really good feedback both on patient results as well as physicians liking the approach, which is the posterior approach versus the lateral approach as well as the simplicity of the device. They're excited to bring that into the practice. And so we're going to now be standing in operating rooms where the physician is using competitive SCS products and our best reps or all of our reps will be actually taking some cases away and talking about the benefits of high frequency therapy. And so that's how we're going to use it to be not a distraction on focus, but a leverageable asset to be able to get into more cases.

Speaker 9

Okay. And then my follow-up is, how should we think about U. S. Pricing for the neuromodulation business? I think you mentioned that some of your competitors may use that lower pricing as a tactic.

Speaker 9

What was pricing in the quarter in the U. S? Have you seen a big change? Any color there would be great. Thanks for taking my questions.

Speaker 2

Yes. Bill, just to make sure my comment earlier on pricing, actually when people launch new products, they're getting a gain in pricing. And so you see some of their revenue actually pop more than just gaining 1 or 2 cases with the physician. They're also gaining pricing right off the gate. So you sort of get a good uplift from maybe taking a few cases here or there as well as the pricing increase at the time, which shows in their top line results.

Speaker 3

Yes. And then Bill, overall in the U. S, it is a competitive landscape, but I'd also say the pricing has actually held pretty well. We saw our average IPG pricing increase in Q2. So we continue to hold price and receive a premium price on our product as a result of our therapy and the technology and the clinical results that our product stands on.

Speaker 3

So overall, we've been pretty pleased with our pricing. There are pockets in certain places where you have to get maybe a little bit more creative, but overall pricing has been holding pretty firm.

Speaker 9

Great. Thanks for taking my questions.

Operator

Your next question comes from the line of David Riccotte with Baird. David, your line is now open.

Speaker 10

Great. Thanks for taking the questions. 2 from us and I'll ask them both upfront. You heard a lot of question kind of comments on your position in the market, share gain potential that's out there. I'm wondering if we take a step back and just think about the entire kind of SCS market that's out there and what you think a kind of true market growth rate is here when you think about the different share that's going on between different players?

Speaker 10

And how I guess longer term and maybe the answer is kind of the SENZA RCT study, SENZA sensory study, do you think that the market maybe can have or drive a bit more growth? That's the first question. The second one from us, just I heard, I think, some comments around potential new product coming out there, I believe, 2026. So just curious if you could add any incremental color on that. Thank you.

Speaker 2

Yes. So as far as market right now, 3 of the 4 public companies have released earnings and then we have one more coming in a few weeks here. And so you definitely saw slowing from Q1 in 2023 into this quarter just by pure math of the numbers for where we see specifically in the U. S. Side of the business.

Speaker 2

The other 2 that reported already had strong growth internationally. We ended up having a couple of headwinds that are unique in nature and one time events, that should correct themselves moving forward. But our OUS business is pretty small relative to our U. S. Business.

Speaker 2

But if you add those together, we definitely went from a mid to high single digits grower to more of a low single digits within this quarter, again, just by numbers. We'll see what the last company when they report does that move that up a little bit further with one of their new product launches. And so as far as the second RCT study, the SENSA study, that is specifically for our second study for PDN. And as I mentioned earlier, PDN is less than 1% penetrated. And look, we were the first ones to come out with the indication and drove that market over the last couple of years.

Speaker 2

We still believe that that is going to be a long term growth driver for the entire market, but specifically for us with the 10 kilohertz therapy. As I've said all along, why would you want to put a patient to have tingling and numbing in their legs, which a lot of our competitors need to do when that patient is already having those side effects of their painful diabetic neuropathy. And we're the only ones that have a large RCT study showing the benefits. It's our belief and what we're going for and look, we are on some of the recommendations, but to get guidelines that say this is the therapy you should use, from some of the societies, we need to have the second RCT. And so if we can get that next year, that'll definitely be some wind in the sales for referring physicians to follow those guidelines for diabetic patients that ultimately need the pain relief therapy that can get them back on their path to recovery.

Speaker 2

So we feel good about that. And then in 2020 6, our SCS device will always be built on our patented 10 kilohertz therapy, but there are some unique clinical benefits we have seen, real world data, as well as some of the testing we've done with some differences, different ways to actually give that therapy to patients. And that will have a lot of different benefits for both providers and for the patients themselves. It's pretty much all we're going to say at this point, but just like we've done all along with our first high frequency device, over 10 years ago here in the U. S, we're going to have those same kind of unique advantages of that product that we believe will be another big bolus into the market.

Operator

Ladies and gentlemen, this concludes our Q and A session and today's conference call. Thank you for your participation. You may now

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Nevro Q2 2024
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