Good afternoon. My name is David, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Nevro Second Quarter 2022 Financial Results Conference Call. Today's conference is being recorded. 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] I'd now like to turn the call over to Julie Dewey for introductory remarks. Please go ahead..

Good afternoon, and welcome to Nevro's second quarter 2022 earnings conference call. We appreciate you joining us. I'm Julie Dewey, Nevro's Chief Corporate Communications and IR Officer. With me today are Keith Grossman, Chairman, CEO and President; and Rod MacLeod, Chief Financial Officer.

The format of our call today will be a discussion of second quarter business results from Keith, followed by detailed financials and guidance from Rod, and then we'll open up the call for questions.

Please note, there are also slides available related to our second quarter performance on the Nevro Investor Relations website on the Events and Presentations page. Earlier today, Nevro released its financial results for the second quarter ended June 30, 2022.

A copy of our earnings release is available on our Investor Relations section of our website at nevro.com. This call is being broadcast live over the Internet to all interested parties on August 3, 2022, and an archived copy of this webcast will be available on our IR website.

Before we begin, 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. Our results could differ materially from those expressed or implied as a result of certain risks and uncertainties.

Please refer to our SEC filings, including our Annual Report on Form 10-K filed on February 23, 2022, for a detailed presentation of risks. The forward-looking statements in this call speak only as of today, and we undertake no obligation to update or revise any of these statements.

In addition, we'll refer to adjusted EBITDA, which is a non-GAAP measure that is used to help investors understand Nevro's ongoing business performance. Non-GAAP adjusted EBITDA excludes certain litigation-related expenses and credits, interest, taxes and non-cash items such as stock-based compensation and depreciation and amortization.

Please refer to the GAAP to non-GAAP reconciliation tables within our earnings release. And now, I'll turn the call over to Keith..

Thanks, Julie. Good afternoon, everyone, and thank you for joining us today. I want to focus my comments on our second quarter results, the current state of our business and recovery and on the progress of our PDN launch. Following my comments, Rod will cover the specifics of our Q2 results and our guidance.

Overall, we continue to move our business forward in Q2, evidenced by overall revenue that was in line. PDN revenue growth that continues to impress us and adjusted EBITDA results that were above the high end of the guidance range.

Despite these results, we continue to experience the lingering impact of customer facility and staffing issues that serve to slow overall patient throughput, particularly of permanent implant procedures.

And we believe our market is still moving down the path of a more durable recovery, though we believe the pace of that recovery may continue to be slower and more uneven than we had originally anticipated, at least in the near term. There have been many encouraging elements of our progress to date.

We are particularly pleased with our revenue growth in the U.S. in the quarter, which was 14% ahead of our pre-COVID pace in 2019. We're also extremely encouraged by the progress of our PDN launch as we continue to drive patient referrals and have made continued progress with payers.

We also believe we've begun to build some early momentum with our indication to treat non-surgical back pain patients. And finally, as we announced on Monday, we were able to reach a settlement in our litigations with Boston Scientific.

Now as part of that settlement, Nevro will receive a license to Boston Scientific asserted patents, a covenant not to sue for any features embodied in current Nevro products, dismissal of all current litigations, a payment of $85 million in cash and a release of the $20 million verdict Boston Scientific was awarded by a Delaware jury last November.

The release allows Nevro to reverse the $20 million loss liability that has accrued in the third quarter of 2021. The resulting accounting is $105 million positive P&L impact to Nevro in the third quarter of '22.

Please note that we've not licensed or compromised in any way what we consider to be our core high-frequency IP, which ranges from 1.5 to 100 kilohertz. The license to paresthesia-free therapy we granted to Boston Scientific was limited to all frequencies below 1.5 kilohertz, which is where Boston Scientific has been competing.

We remain the exclusive provider of our unique best-in-class HFX 10 K therapy. The terms of the settlement agreement beyond what was stated in Monday's press release and the 8-K we filed are confidential. So we'll not be able to answer many of your questions beyond what has already been publicly disclosed.

But of course, we're pleased to have this behind us. Now let's take a look at actual procedure activity for the quarter. Despite the staffing shortage and capacity impacts, particularly late in the quarter, Q2 total U.S.

permanent implant procedures increased 8% compared to prior year and 13% compared to Q2 of 2019, while trial procedures increased 14% compared to prior year and 4% compared to Q2 of 2019. I'm encouraged by the increase in trial procedures we saw in the quarter.

And while we now expect normal seasonality in Q3, we continue to see encouraging year-over-year trial growth. Our data confirms to us that patient willingness to engage is still improving and importantly, the underlying fundamentals of the addressable market and the opportunity for attractive growth rates remain intact.

Based on this and the trend in trial procedures, we believe the SCS market is moving toward recovery and is positioned to return to more attractive revenue growth rates later in the year as the funnel of trial procedures continues to refill. Lingering staffing issues, however, put pressure on the scheduling of SCS procedures.

Now while this includes trial procedures, it's particularly evident in perm procedures, which serves to lengthen our trial to perm or T2P conversion curve or the average time to convert patient trials to perms and therefore, revenues. We expect this to improve later this year and into 2023.

In the meantime, even though trial performance continues to improve, albeit at a somewhat slower pace than we planned, this lengthened conversion curve has much to do with how we're thinking about second half and particularly third quarter revenues.

Our updated guidance that Rod will discuss in more detail later takes us into account, though it's important to remember that this revised guidance still reflects total revenue growth for the second half of the year, up 7% to 12% on a constant currency basis.

In July, our team completed some market research with hundreds of implanting SCS physicians and chronic pain patients, and we reviewed recent claims data as well. In general, this survey work confirms that things are getting better, if not at the pace we had originally planned.

In our physician research, 55% of those surveys noted higher monthly trial volumes in the last few months as compared to last year though not quite yet back to 2019 levels.

The primary market dynamic that physicians told us was having an impact on SCS procedure volume with staffing challenges, though patients financial concerns was also cited by some.

For the month of July, 92% of physicians told us they continue to experience staffing challenges such as office turnover and newer, less experienced office staff, which impact patient scheduling, office efficiency and importantly, OR scheduling and therefore, overall procedure throughput.

Fortunately, 53% of physicians noted they're also seeing an influx of new patients who delayed treatment due to the pandemic, who they believe will be the drivers of market recovery.

Now in our patient research, they told us they've had difficulty in scheduling appointments with pain providers, which is, of course, consistent with feedback we received from the physicians, I mentioned a moment ago. Not surprisingly, patients also expressed sensitivity around higher co-pays and deductibles.

Now this has always been the case, though we were certainly not surprised to hear it in this current environment. Encouragingly, 45% of patients say they are seeing their pain doctor more than last year and 88 patients who delayed or canceled a pain procedure in the last six months, said they plan to have the procedure before the end of this year.

Now turning to claims data for actual procedure volumes in the U.S. SCS trials and perm trends are consistent with that survey work. Based on the latest third-party claims data for actual procedures, U.S. permanent implant procedures for the total U.S.

market in the first five months of '22 were up 1.5% compared to prior year, but are still down 4% compared to the same period in 2019. Nevro perm procedures on the other hand, were up 5% for the first five months of '22 compared to the same period last year and up 13% versus the same period in 2019.

Now these data are particularly important because while revenue growth numbers can be impacted by a number of things, including timing of shipments, these procedural growth numbers are more accurately indicate what products are actually being implanted in patients and there are really good indication of share trends.

For the first five months of the year compared to '21 and '19, Nevro outpaced market procedure growth rate by 350 and 1,700 basis points, respectively. So we're confident that we continue to win competitively. Remember, these are our actual procedures not reported revenues.

So the prior year period comparables are not impacted by things like destocking issues from 2019 that some of you might remember, for example. Regarding our PDN performance, we've now passed the one-year mark for our commercial launch, and we're really pleased with what we're seeing.

We've educated and driven awareness with thousands of referring physicians and patients and significantly increased patient access to the therapy. During the quarter, PDN trials in the U.S. grew 45% sequentially compared to Q1 despite the lingering market issues that I've been describing. PDN trials represented approximately 14% of our total U.S.

trial volume, up from 11% of total U.S. trial volume in Q1 and they improved throughout the course of the quarter.

As it relates to permanent implant procedures, PDN represented 11% of our total procedures worldwide and that resulted in approximately $11 million in PDN revenue contribution, and that's an increase of 83% sequentially compared to $6 million prior quarter.

We've now completed the planned expansion of our PDN referral territories, bringing the total number of PDN reps to approximately 50. These additional reps have been trained, and they're all now in their territories.

Our existing SCS sales team calling on our pain specialists continues to generate interest among our implanting physicians to reach out to referring physicians in their local communities and drive awareness for our therapy for these patients.

As we mentioned in our last call, a number of pain physicians that say they are proactively seeking PDN referrals has nearly doubled from before our approval, and that continues to grow.

At the end of June, nearly 60% of our implanting physicians have received one or more PDN patient referrals, when pain physicians initiate local outreach and marketing and share individual patient successes, we've seen the PDN can rapidly become a really meaningful percentage of their monthly patient volume.

For example, if we look at our very top PDN implanting physicians, we've seen that for some PDN can quickly grow to as much as 25% to 45% of their monthly volumes. Further up the patient demand funnel, we continue to invest in and strengthen our direct-to-consumer campaign in order to acquire and activate qualified patient leads.

The percentage of PDN patient and trial procedures coming from our DTC efforts is growing as our HFX coaches and sales team members continue to educate these leads. As a point of reference in the month of June, 16% of our U.S. PDN trial procedures came from these DTC patient leads.

At this year's ADA Scientific Sessions in June, we were excited to share for the first time, the 24-month results from the 10 K or treatment arm of our landmark SENZA-PDN trial, which continue to clearly demonstrate the safety, durability and consistency of pain relief and other outcomes that can be achieved with HFX for PDN.

While prior research has looked at the benefit of SCS for treating pain related to diabetic neuropathy, this is the first time that neurological improvement after SCS has been studied.

Our data showed a 72% neurological symptom improvement, a 69% average reduction in sleep disturbance and an average improvement in quality of life that was 3 times the minimal clinically important difference. No traditional low-frequency SCS treatments have demonstrated such positive results in treating these patients.

And we believe there's a significant opportunity to expand this innovative treatment option to PDN patients, who are unable to find relief with any other options.

We're also pleased that the complete 12-month results from the SENZA-PDN trial, which included health-related quality of life outcomes published in the Mayo Clinic Proceedings in early July.

These results demonstrate improvement in several important health-related quality of life metrics in patients with PDN, including significantly less pain interference with sleep, mood and daily activities.

Importantly, a 12-month 10 kilohertz SCS treatment resulted in improvement in overall health-related quality of life that was 2.5 times to 4.5 times higher than the difference that is considered clinically important.

We expect to complete 24-month data to be available in Q4, and our plan is to submit that data for presentation at NANS in January '23 and to publish as soon as we can thereafter.

In the critical area of payer coverage, a number of coverage updates among Blue Cross Blue Shield or BCBS Insurers were announced to explicitly cover PDN during this past quarter. These included updates from BCBS providers in Alabama, Hawaii, Idaho, the Pacific Northwest, Illinois, Montana, New Mexico, Oklahoma and Texas.

Combined, these BCBS updates represent nearly 23 million commercially insured covered lives with nearly 50% of the U.S. -- of the addressable U.S. PDN population now covered under a formal policy update for PDN. That's up from 25% as recently as the start of the year.

We attribute this recent momentum from these plans to our proactive engagement with Evidence Street, international health tech assessment arm. Evidence Street's June update of the SCS evidence-based review incorporated our clinical evidence on PDN, which we submitted to them in January.

Remember the coverage policy decisions are important, but they're just part of our efforts. We continue to see a high level of patient coverage on a case-by-case basis through the prior auth process and the appeal of payer denials, including with payers who do not have a specific PDN coverage policy.

For PDN cases that have come through our own access group, our cumulative approval rate as of the end of June climbed to 84%, up from about 62% at the beginning of the year.

Based on our strong PDN performance in the first half of the year, our '22 sales guidance now includes a $42 million to $45 million contribution from PDN, up from our original guidance of $25 million to $30 million at the beginning of this year.

Moving now to non-surgical back pain after receiving FDA approval of this indication in January, we began commercial activities to expand access to HFX therapy for this population. We saw sequential growth in NSBP trials during Q2 with these trials coming from both current and new users.

This is a large and underpenetrated market, as we've discussed, with approximately 0.5 million patients annually in the U.S. who are not candidates for surgery and who have limited treatment options available when less invasive therapy and medical management are not successful.

While NSBP has historically made up around 30% of our patients, only about 5% of this large patient population are currently receiving this therapy. Our strategy focuses on the identification and education of patients already at these existing pain practices who have not had prior surgery and who are not candidates for surgery.

So far, these customers are excited and receptive to our outreach and they're actively looking for patients to treat. We also continue to prepare for the launch of our next-generation product platform.

This new system will be the first significant step in leveraging the over 80, 000 and 20 million clinical data points in our HFX cloud database to intelligently inform the delivery of our superior high-frequency therapy. We plan to begin a limited market release once we receive FDA approval, which we hope will come before the end of '22.

Now we'll provide a lot more detail at that time, but we're really excited about the power of this platform and what it can do for us and our patients immediately and over time. So in closing, we made encouraging progress in our core SCS and PDN businesses in the second quarter.

And while clearly, the challenges of the last couple of years are resolving a bit more slowly than we hoped, we're seeing the start of what we believe will be continued recovery in our markets as well as cause for real excitement in our emerging growth drivers.

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

Thanks, Keith, and good afternoon.

I'll begin with our worldwide revenue for the second quarter of 2022, which was $104.2 million, an increase of 2% as reported and 4% on a constant currency basis compared to $102.3 million in the prior year period and an 11% increase as reported and 12% increase on a constant currency basis, compared to $93.6 million in the second quarter of 2019.

PDN represented 11% of worldwide permanent implant procedures, which resulted in approximately $11 million in revenue in the second quarter of 2022. As a reminder, this quarter included the same number of selling days as Q2 '21 and Q2 2019. U.S.

revenue in the second quarter of 2022 was $89 million, an increase of 5% compared to $85 million in the prior year period and an increase of 14% compared to $78.1 million in the second quarter of 2019.

International revenue was $15.2 million, a decrease of 12% as reported or 3% constant currency compared to $17.3 million in the prior year period and a decrease of 2% as reported or flat on a constant currency basis compared to $15.5 million in the second quarter of 2019.

International revenue, particularly in the United Kingdom and Australia continue to be impacted by COVID-related issues though these factors improved over the course of the quarter. Now moving on to some detail below the top line.

Gross profit for the second quarter of 2022 was $72.7 million, an increase of 4% compared to $70 million in the prior year period. Gross margin increased to 69.8% in the second quarter of 2022 compared to 68.4% in the prior year period.

We continue to make investments in our Costa Rica manufacturing facility ahead of FDA approval of this facility, which we expect in the second half of the year.

Operating expenses for the second quarter of 2022 were $96.5 million, a 13% increase compared to $85.7 million in the prior year period and a 7% increase compared to $90.5 million in the second quarter of 2019.

Looking at operating expenses year-over-year, the increase was primarily related to personnel-related costs, PDN selling costs and meeting and travel costs, partially offset by lower litigation fees. Excluding all litigation-related PDN expenses, operating expenses would have been approximately flat compared to the second quarter of 2019.

Litigation-related legal expenses were $4 million for the second quarter of 2022 compared to $6.6 million in the prior year period and $4.5 million in the second quarter of 2019. As Keith mentioned earlier, we reached a settlement in our litigation with Boston Scientific.

This settlement ends all litigations between the companies, which will have a positive impact on our ongoing litigation-related legal expenses. Looking ahead, for obvious reasons, we will not be able to answer questions about our enforcement strategies against other industry competitors. However, we will restate what we said before.

We will continue to invest in defending and enforcing our IP relating to spinal cord stimulation technology and particularly our IP-related to paresthesia-free SCS therapy.

Net loss from operations for the second quarter of 2022 was $23.8 million compared to a loss of $15.8 million in the prior year period and a loss of $26.6 million in the second quarter of 2019.

Non-GAAP adjusted EBITDA for the second quarter of 2022 was a loss of $4.5 million compared to a process of $3 million in the prior year period and a loss of $11.1 million in the second quarter of 2019. Cash, cash equivalents and short-term investments totaled $310.8 million as of June 30, 2022.

This represents a decrease during the second quarter of 2022 of $12.8 million. The impact of the recent settlement with Boston Scientific will be included in our Q3 results. We continue to manage our working capital and are comfortable with our balance sheet to fund operations. Now let's turn to guidance.

It's 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.

Keep in mind that the guidance that we are providing today is highly sensitive to the company's assumptions regarding the pace and sustainability of COVID recovery and its related impacts on patient willingness to seek elective care, healthcare facility restrictions and healthcare facility staffing limitations, all of which are difficult to predict as we've seen.

We're keeping a close eye on macroeconomic issues and their impact on patient behaviors. But for now, our guidance does not assume a material impact from inflation or recession-related impact beyond any that we are already seeing.

If these assumptions differ from the actual pace of COVID recovery and its impact on the company's markets and the company may need to change or withdraw this guidance in the future. Earlier, Keith mentioned that the trial-to-perm conversion curve has lengthened. We track our trial-to-perm curve very carefully.

In Q2, we saw an impact of approximately $3 million due to the lengthening of the trial-to-perm curve. Our guidance assumes that this trial, the perm curve remains at current levels for the balance of the year and doesn't improve or worsen. We expect third quarter 2022 worldwide revenue of approximately $97 million to $101 million.

Assuming foreign currency exchange rates hold at current levels, this guidance includes a negative currency impact of approximately $1 million or growth of 6% to 10% on a constant currency basis. This guidance assumes that the recovery will continue to steadily improve in the quarter.

Although, PDN is not immune to the staffing issues we are seeing, we believe PDN revenue in Q3 will be slightly ahead of Q2 given the underlying momentum in this indication. We expect third quarter 2022 non-GAAP adjusted EBITDA to be a loss of approximately $6 million to $9 million.

We now expect worldwide revenue for full year 2022 of approximately $400 million to $410 million, which implies growth of 3% to 6% over the prior year, with growth in the second half of the year of 6% to 11%.

Assuming foreign currency exchange rates hold at current levels, this guidance includes the negative currency impact for the second half of the year of approximately $2 million. This translates to second half growth of 7% to 12% on a constant currency basis.

Our guidance assumes $42 million to $45 million in PDN revenue in 2022, an increase from our previous guidance of $27 million to $32 million.

This guidance assumes the remainder of 2022 will see a steady recovery, particularly in Q4 and includes no significant business impact from new COVID variants or waves and near-term improvement in healthcare facility restrictions and steady improvement in healthcare facility staffing limitations throughout the year.

We are also updating our full year 2022 non-GAAP adjusted EBITDA guidance to be a loss of $19 million to $25 million, which compares to previous guidance of a loss of $8 million to $18 million and a non-GAAP adjusted EBITDA loss of $17.2 million in 2021.

The Medtech space in general continues to face macro challenges, including FX and inflation, which, together with COVID disruptions present a more challenging near-term environment. Our updated revenue guidance assumes foreign currency exchange rates hold at current levels.

Regarding inflation, as we said on our last earnings call, to date, we are seeing some expected impact in areas such as freight and cost of goods. Our supply chain and cost of sales has shown modest increases that were anticipated and in time are expected to be more than offset by Costa Rica manufacturing cost reductions.

We are also seeing some inflationary pressure on certain operating expenses, such as compensation, which is already contemplated in our guidance. We continue to manage our costs and miss these pressures and expect that we will be able to drive leverage over the next several years in our income statement.

In closing, we made good progress in the second quarter and remain on track to drive growth and scale profitably in our core business in the years ahead.

We are in a great position strategically with best-in-class SCS technologies, remaining share gain opportunity, future growth opportunities in PDN and NSBP, superior clinical data and a strong commercial organization. We look forward to aggressively attacking the significant opportunities to drive the performance of the business the rest of the year.

That concludes our prepared remarks. I'll turn the call back over to Julie 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 quick follow-up. You can then rejoin the queue, and if time allows, we'll take additional questions. Operator, we are ready for Q&A instructions..

Thank you. [Operator Instructions] We'll take our first question from Larry Biegelsen with Wells Fargo. Your line is now open..

Good afternoon. Thanks for taking the question, and Keith, congrats on a good quarter here.

Can you hear me okay?.

I can, Larry. Thank you..

Yeah. Great. So Keith, overall, it was an encouraging quarter. You're clearly doing well with PDN, but core SCS is still weak.

How do you think about the trade-off between PDN and core SCS and how you can better leverage PDN to drive core SCS sales?.

Yeah. Well, I think if I look at our results, I think that to some extent, it actually has. If you look at U.S. -- total U.S. perm procedures without PDN for the total market in the first five months of the year, they were down 4% and 13% compared to 2019.

If you look at our perm procedures, again, without PDN, they were up 1% for the first five months compared to the last year, and they were down only 3% compared to 2019. So I think what we're seeing is there actually has been and I think there will continue to be more updraft on our core business from PDN.

I think what we're dealing with here is just a larger --is a larger market issue where we're seeing positive things happening. They're just not happening at the rate we originally planned. And we think that's particularly true here over the summer months. We continue to think we're headed to the same endpoint.

It's just maybe a little bit of difficulty in predicting the shape of that curve..

That's helpful. And just for my quick follow-up, the second half guidance of 7% to 12% constant currency, by our math, it's over 10% growth in Q4. Could you put that into context for how we should be thinking about 2023 and what kind of contribution we could expect from the new product? Thanks for taking the question..

Well, obviously, we don't have any guidance in place for '23. I will tell you that as we think about at least the PDN portion of our business, it has met or in most cases, exceeded our internal expectations so far this year. And we think it will for the rest of the year, thus the revised guidance.

I would expect that trend to continue through '23, but we haven't quantified that yet, of course, Larry. And that's also true for the core business. We'll obviously have a much better feel for that as we see the fall months kind of unfold here..

All right. Thanks so much for taking the questions..

Next, we'll go to Cecilia Furlong with Morgan Stanley. Your line is open..

Thanks for taking the questions. This is Calvin on for Cecilia. Just two quick ones for me. First, I wanted to ask about just PDN traction versus the macro environment.

Just from the standpoint of any potential limiting factors to your initial PDN momentum between kind of market development referral channel build-out and staffing shortages, I'm just curious whether staffing shortages has been a real kind of headwind against your stronger demand where perhaps have you seen a case where patient volume and demand have been strong, but your PDN numbers are somehow constrained by staffing bandwidth and patients may need to be turned away or rescheduled.

Is that the case at all so far or is market kind of referral development, the more prominent driver for your PDN numbers so far?.

It's actually an interesting question, Calvin, because I think despite the performance in the PDN sector and how encouraged we are by it, there's no question in our mind that PDN has been impacted over the same period of time by the same factors and would have in the absence of those factors been better yet.

We don't think the trial-to-perm conversion curve issue is as much of an issue with PDN patients, which is very interesting to us. I think there's an incentive on the part of our treating customers and frankly, the part of our patients to move through as quickly as possible.

And so we don't see quite the same T2P conversion curve delay with our PDN patients that we see with our core patients. But the rest of the friction in the system with regard to staffing and block times at hospitals for different procedures and other issues. Those all apply to PDN as well.

And I think that's why we've been really particularly impressed with how well that's gone thus far..

Got it. That's very helpful. A quick follow-up. Just can you comment on the progress on your PDN sort of referral sales team build-out and the outreach initiative, I think, in the quarter. You previously noted you, your plan to expand this team by about 50% throughout 2022.

So just wondering how that's tracking, what's the progress here and perhaps any associated OpEx impact? Thanks so much..

We actually mentioned during the remarks that those -- that expansion taking that referral sales organization up to 50 reps is done. Those reps are trained. They're in the field and they're actively calling on referring accounts now.

And I will tell you that I think we've -- in the first wave, we've learned a lot about where to put these reps, where we hire them from, how we train them, how we make them successful. So I think we're seeing probably a shorter learning curve with this second wave of reps.

But I think we're actually really happy with the traction that we're now starting to see on direct-to-consumer activities and the productivity we're seeing and continuing to see from our PDN referral sales force.

And then finally, the results in the areas where our pain physicians have really grabbed control of their local referring base and have really educated that referral base themselves. And that makes a huge difference.

So I think those are the three buckets of things that continue to move the needle, and we're actually pretty happy with how they're going..

Great. Thanks so much..

Next, we'll go to Adam Maeder with Piper Sandler. Your line is now open..

Hi. Good afternoon. This is Simran on for Adam. Thanks for taking the questions.

So maybe just digging into the dynamics that you mentioned in the broader SCS market, have you noticed any fundamental shift in patient demand or is the pace of recovery primarily constrained due to all of these macro headwinds? Because I guess like, what I'm trying to get to is how much potential backlog could there be to work through and do you see that playing out in Q4 and into 2023?.

Yeah. We haven't noted anything in all of our work, and we've done a lot of it, as you know, indicate that there's any fundamental change in patient demand, either towards doing nothing or doing something different or some sort of resolution of their problem. All of those things continue to point to the same direction.

And all of our work with patients continues to indicate that they plan to continue to seek treatment. We gave a little bit of data in our comments about what was -- what we heard in both our patients and our physician research.

But I don't think we see any real fundamental change in patient demand for pain therapy generally or for SCS therapy specifically. Now having said that, trying to quantify the timing and impact of any pent-up demand has proven to be -- of the really, really tough task.

And so while we know that our doctors are saying they are seeing patients come back who are -- who claim to be patients that canceled their plans during the pandemic. That's encouraging. But trying to quantify how many patients are out there, if when and at what pace they will come back has proven to be pretty difficult.

And I will tell you that in our guidance that is not a fundamental assumption. We're not assuming some bucket of patients out there that we're not seeing who are going to magically come back. We're looking at fundamentals like trial rates and some of the input we're gathering in our market research..

Okay. Perfect. And maybe just a quick follow-up.

Can you expand a little bit about the international business and what kind of trends you're seeing in the market there?.

Yeah. I think in general, the -- I think from the beginning, in most quarters since the beginning of the pandemic, our international business has probably been more severely impacted by the pandemic and related environment than the U.S. business.

It was, for the most part, not every month or every quarter, but for the most part, hit harder and has recovered a bit more slowly. We called out two country markets where we think that's been the case more than others and that's the U.K. and Australia. We believe in the case of both of these markets, they will come back.

We also think it will be somewhat slow. And for different sets of reasons, but we think that the incentives, the healthcare economics in those systems are different from one another, but also different from the U.S. and we think they'll just both return to pre-pandemic health slower than other markets..

Perfect. Thank you..

Next, we'll go to Robbie Marcus with JPMorgan. Your line is open..

Yeah. Thanks for taking my questions. Maybe to start on spending, adjusted EBITDA guidance is moving lower. How do we think about your current level of spend. You're building up PDN and PDN is doing well and ramping nicely. But the rest of the businesses, as you just responded slower.

How do you think about what the right level of spending is? And maybe if you'll upon where you think you see the intersection of expenses and profits to turn to positive net income? Thanks..

Why don't I take the first part of that, and I'll let -- I'll ask Rod to take the second part. I think how we think about it in general is that we're working pretty hard to control spending where it is absent those areas where we feel we really need to invest in either growth or structural changes in the business.

For example, the PDN commercial effort, that's not something where we're really watching the wallet. We believe that's a very large market opportunity. I think it's beginning to show and has the opportunity to drive a lot of growth. I think that's going to continue, and we want to fuel that.

And so -- and that's -- so that's an area where we're trying to reasonably aggressively fuel that growth curve. We're making some investments in Costa Rica. Why? Because we think that's a big improvement in the position of our business and in our gross margins over time. And Rod has talked a little bit about what that can mean in the past.

And of course, we've spent pretty liberally to defend our IP in the past. And while we expect that spend to go down based on the settlement, that's an area where we've been pretty aggressive in our spending, and we think for good reason. Outside of those areas, what we've tried to do is maintain the organization.

We've never felt like the impact from the pandemic was permanent as difficult as it's been to predict, we've never felt that it's been permanent and we still don't. So we never wanted to degrade the capabilities of the organization to fuel growth going into the future. And I think that's still where we are.

If we were to reach a different conclusion about the core market, then I think we would view our expense burden very differently. I know I would. But I think we've been pretty consistent internally on that. We feel like we've got the market logic and the balance sheet to support that.

Rod, maybe you want to talk a little bit about how we're viewing leverage and whether or not it's changed..

Yeah, Robbie. I agree with everything that Keith just mentioned and also reiterate the changes that we've made in our sales channel in terms of patient support and delivery as well as product changes that we've made over the last number of years. We believe that we're in a position to scale the business well.

And we still believe that when we get into that kind of $110 million in quarterly revenues that we're going to be right around that adjusted EBITDA breakeven point and we still stand by that. And as some of these -- as this recovery continues, we believe we're in very good shape to be able to generate more leverage on the P&L..

Rod, maybe I'll use my follow-up question here. To that last point, I mean you'll be pretty close to that in the fourth quarter yet adjusted EBITDA guidance is moving down. So what's the delta in between those two statements? Thanks a lot..

Yeah. Well, we -- I mean, we're showing a loss in the first three quarters. And I do think that we're going to be in pretty good shape. And obviously, the spending, depending on particular some areas with PDN and some other parts of the business, they might fluctuate a bit from quarter-to-quarter.

But when we get above that $110 million, we should start to see hitting that breakeven and getting some drop through above that..

Great. Thanks a lot..

[Operator Instructions] Next, we'll go to Joanne Wuensch with Citi. Your line is now open..

Hi. This is Anthony on for Joanne. Thanks for taking our questions. My first is, I know you talked about that sort of trial-to-perm curve lengthening through the quarter.

Are you seeing maybe any higher rates of dropout sort of between when a patient does a trial and when they get permanent procedure?.

Yeah. So we're -- so far, we're not seeing any degradation in overall conversion. In other words, if you were to expect, say, two-thirds, somewhere between two-thirds and 70% of your trial patients ultimately convert to perms. We're not seeing any change in that. What we're seeing is just a flattening of the curve.

So instead of, say, 50% of those patients converting within the first 90 days post-trial, it's something less than that. And -- but we're not -- if we look back over seven, eight, nine, 10 months and we look at the patients that ultimately do convert, those numbers seem to be holding where they are.

So at least so far, we're not seeing any permanent drop out. We're just seeing a shifting based on kind of what's happening currently, and we think that means that it will snap back at some point..

Okay. And then my second, just back to PDN, what is sort of the back half of the year guidance assume in terms of reimbursement win? Can you hit that PDN number with the covered lives you have now or are you assuming maybe some more substantial adds in the back half of the year? Thanks..

Yeah, that's really, really hard to predict. And sometimes we're surprised when these commercial payers show up with their decisions. I think in the long run, we don't expect the total coverage really to be any different than our traditional lower back and leg patients, which is extremely high.

I mean it's 90%, 95% plus of commercial patients who are in a plan where they have explicit coverage. And I think that's where we're moving with PDN. Where we'll be at the end of the year, really hard to say, I think we're really happy we've gone from 25% to 50% in the first two quarters of this year.

But it's impossible to extrapolate a certain pace in covered lives over any particular time frame. So you'll have to bear with us on disclosures there..

We'll move to our next question to Rich Newitter with Truist Securities..

Hey. This is Dave Rescott for Rich. First, from us just around the dynamics in the core SCS mark, I mean I think you mentioned that some of the top PDN and paying physicians are seeing anywhere from 35% to 45% of the volumes coming from PDN.

So do you think, if at all, either from a volume perspective or maybe just internally from the way that the sales force is focused on core versus the PDN sales, if at all, the kind of growth or success you're seeing within PDN is having an impact on the underlying core SCS volumes?.

Yeah. I think I know where you're going with that. I earlier in the Q&A session, we had a question and I read through some market data that excluded our PDN volume, where we still think we're doing better the market -- better than the market. So I think in the macro, no, that's not happening.

We've had the question expressed differently, which is, is it possible that in any particular case, a doctor might be in giving you their PDN patients given one of your competitors, they're back in leg patients. We haven't seen that in any large sense. And the data, as I mentioned, just don't bear that out.

Occasionally, we see it on an individual practice basis, where a doctor has two or maybe even three incumbent providers, and they are giving us more volume for PDN, and they will begin to give a competitor more volume in back and leg. But over the whole market, we've not seen that. So I'd say as a -- in general, as a trend, that's not happening.

We think there's actually been the opposite. We've got a little bit of enough draft in our back and leg paying growth due to PDN..

Okay. That's helpful. And then I guess just around the -- within, I guess, SCS as a whole around kind of some of the pricing.

I mean, is pricing -- have you seen any changes either competitively or within your own kind of market as far as any type of negative impact from pricing or I think it's a pricing erosion? And if at all, that could be a strategy as a way to gain share in the U.S. market at least going forward? Thank you..

Yeah. I'll take that. So we continue to price our products at a premium and are happy with the pricing in our products and in our sales channels that have been able to garner. With that said, similar to previous quarters, we're in a competitive environment.

We do continue to see some pricing pressure -- and at times, depending on the account, we may go and match or move in that sort of direction. Year-to-date, we're seeing somewhere around 150 basis points in the U.S. from a pricing pressure standpoint, and it's something that we monitor and we manage pretty closely..

Let me just add one thing to that. I think quite a lot of that that we've seen year-to-date is due to a mix shift of site of care from hospital to ASCs. And we've seen that throughout the pandemic and ASCs typically bring a little bit lower price point than hospitals.

And so as the mix shifts from hospitals ASCs, you see a little bit of overall ASP pressure..

All right. Thanks for taking the questions..

Next, we'll go to Margaret Kaczor with William Blair. Your line is now open..

Hey, guys. This is Maggie Boeye on for Margaret today. Thanks for taking our questions. I wanted to start just digging in deeper to the core SCS market. So as you think about the future and what growth could look like and obviously, I can appreciate that it's hard to predict now with staffing shortages and that making the road to recovery a bit longer.

But how soon do you think that we can see that full return to market growth? And then included in those assumptions, what are you assuming for potential new entrants into the market as well? Thank you..

Yeah. Well, we've always been a little bit careful, at least in the last few years, about market growth and trying to do too much prognostication there. But I do think, look, we still believe in underlying market growth rates coming into the pandemic will be roughly the same going out.

We think there's a normalized growth rate for this market, particularly with the NSBP indication that we think will be market expansive that is, at least, I think, the conventional wisdom among our competitors as they've been asked this question publicly has all been sort of in the mid- to high-single digits range.

And I think that continues to make sense to us as well as we look at the market. Now in terms of when the back and leg part of the market gets back to that growth rate, I think we'll probably shy away from making that prediction today.

I think as we get to the end of this year, we all believe if the market plays out, the market backdrop plays out the way we think it will, as contemplated by our guidance that we'll be approaching market growth rates that are pretty interesting and pretty sustainable by the end of the year and then coming into '23..

Got it. That's helpful. Thank you. And then just as a follow-up, obviously, you're into the PDN launch at this point and things are going well.

How are you thinking about the growth of that business going forward? And obviously, I can understand that with the rate it's going right now, hard to parse out, but I wanted to see what you guys are thinking about that..

Yeah. We've tried to quantify the addressable market opportunity before, and I don't think that's changed. One of the things we've learned in being in the market a year, oftentimes you enter a market and you begin to uncover market segmentation you really didn't think about before. And I don't think we've seen that here.

I think that there are no segments that are not reachable that are less of a candidate pool for this therapy, et cetera. I think the TAM that we've defined coming into this market as the TAM that we would define after being in the market for a year. So I think we're really encouraged by where this could go. Give us a little bit of time here.

I think when we're giving guidance for '23, we'll be in a better position to talk maybe a little bit more about where we think the total market is going over time. But it's a little bit early for us to do that now, other than just to say we're pretty happy with the way it's going. And it certainly is ahead of our plans..

Got it. Thank you..

There are no further questions at this time. I'd now like to turn the conference back to Mr. Grossman for closing remarks..

Okay. Thanks, everyone, for joining us. We appreciate we've given you an awful lot of information and data today. I know you'll let us know as you have questions, and we'll look forward to updating you next quarter..

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