Nevro Corp.

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 Nebro 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 speaker's remarks, there'll be a question and answer session. We ask that you please limit yourself to one question and one follow-up. If you feel your question has been answered, you may remove yourself from queue by pressing star 1 once again. 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 McLeod, 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 30th, 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 3rd, 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 risk. 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 served 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'd originally anticipated, at least in the near term. There have been many encouraging elements of our progress today. We're 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's 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 dollar verdict Boston Scientific was awarded by a Delaware jury last November. The release allows Nevro to reverse the $20 million loss liability that had 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 10K therapy. The terms of the settlement agreement beyond what was stated in Monday's press release and the 8K 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 this into account, though it's important to remember that this revised guidance still reflects total revenue growth for the second half of the year of 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 was 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, whom they believe will be the drivers of market recovery. Now, in our patient research, they told us they've had difficulty 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 copays 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. NevroPerm 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. 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 more accurately indicate what products are actually being implanted in patients, and they're a really good indication of share trends. For the first five months of the year, compared to 21 and 19, never outpaced market procedure growth rate by 350 and 1700 basis points, respectively. So we're confident that we continue to win competitively. Remember, these are actual procedures, not reported revenues, so the prior year period comparables are not impacted by things like stocking issues from 2019 that some of you might remember, for example. Regarding our PDM 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 US grew 45% sequentially compared to Q1, despite the lingering market issues that I've been describing. PDN trials represented approximately 14% of our total US trial volume, up from 11% of total US 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 on our last call, the number of pain physicians that say they're 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 had 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 US 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 10K or treatment arm of our landmark SAMHSA PDN trials. which continue to clearly demonstrate the safety, durability, and consistency of pain relief and other outcomes that can be achieved with HFX for PDM. 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 three 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 CENTA 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 PDM, 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 two and a half to four and a half times higher than the difference that is considered clinically important. We expect the complete 24-month data to be available in Q4, and our plan is to submit that data for presentation at NAMS 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. Combine these BCBS updates represent nearly 23 million commercially insured covered lives with nearly 50% of the addressable US PDM population now covered under a formal policy update for PDM. 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, their national 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 that 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 to $45 million contribution from PDN, up from our original guidance of $25 to $30 million at the beginning of this year. Moving on 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 NSPP trials during Q2, with these trials coming from both current and new users. This is a large and under-penetrated market, as we've discussed, with approximately half a 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 patients 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 SES and PDM 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. 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. Justin Capposian, US revenue in the second quarter of 2022 was 89 million and increase of 5% compared to 85 million in the prior year period and an increase of 14% compared to 70.1 million in the second quarter of 2019. Justin Capposian, 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, continued 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 litigations with Boston Scientific This settlement ends all litigations between the companies, which will have a positive impact on our ongoing litigations 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 technologies. and particularly RIP related to paresthesia free SDS 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 profit 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 impacts 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 impacts 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, then the company may need to change or withdraw in the future. Earlier, Keith mentioned that the trial to PERM conversion curve has lengthened. We tracked 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 of 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 the syndication. We expect third quarter 2022 non-GAAP adjusted EBITDA to be a loss of approximately $6 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 the current levels, this guidance includes a 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 Rican 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 amidst 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 SES technologies, remaining share gain opportunity, future growth opportunities in PDN and NSBP, superior clinical data in 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. At this time, I'd like to remind everyone, in order to ask a question, press star then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. We'll take our first question from Larry Beagleson 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 OK? 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, you know, to some extent it actually has. You know, 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 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 PDM. I think what we're dealing with here is just 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 of 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. Can 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, you know, 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 PD and traction versus the macro environment, just From the standpoint of any potential limiting factors to your initial PDM 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 You know, have you seen a case where, you know, 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? You know, is that the case at all so far, or is market and kind of referral development the more prominent driver for your PDN numbers so far?

Well, you know, 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-perm conversion curve issue is as much of an issue with PDN patients, which is very interesting to us. I think there's incentive on the part of our treating customers and, frankly, on the part of our patients to move through as quickly as possible. And so we don't see quite the same T to B 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, you know, 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, a sales team build-out, and the outreach initiative, I think, in the quarter? You know, you previously noted you 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, and thanks so much.

Yeah, yeah. Well, 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 continue 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. We're actually pretty happy with how they're going.

Great. Thanks so much. Next, we'll go to Adam Maeder with Piper Sendler. 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 SES 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 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, to 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 we heard in both our patient 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 a really, really tough task. And so while we know that our doctors are saying they are seeing patients come back 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'll 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, you know, 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, 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 health care 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.

Okay, next we'll go to Robbie Marcus with JP Morgan. Your line is open.

Yeah, thanks for taking the 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 business is, as you just responded, slower. how do you think about what the right level of spending is? And maybe if you'll opine 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 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 it has the opportunity to drive a lot of growth. I think that's going to continue, and we want to fuel that. And 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, you know, 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 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 break-even 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 just the EBITDA guidance is moving down. So what's the delta in between those two statements? Thanks a lot.

Yeah, well, 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 – you know, hitting that break even and getting some drop through above that. Great. Thanks a lot.

At this time, I'd like to remind everyone, in order to ask a question, press star then the number one on your telephone keypad. Next, we'll go to Joan Winch 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 the permanent procedure?

Yeah. 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 to 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. 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 dropout. We're just seeing a shifting based on kind of what's happening currently, and we think that means that it'll snap back at some point.

Okay. And then my second, just back to PDN. What does sort of the back half of the year guidance assume in terms of reimbursement? Can you hit that PDN number with the covered lives you have now, or are you assuming maybe some more substantial ads 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 for these 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 PDM. 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 have the next question.

Okay. All right. We'll move to our next question.

Rich Newitter with Truist Security.

Hey, this is Dave Ruskin. Rich, thanks for taking the questions. First, from us, just around the dynamics in the core SCS market, I mean, I think you mentioned that some of the top PDN and playing positions are seeing anywhere from 35% to 45% of their volumes coming from PDN. So do you think you know, 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 SDS volumes.

Yeah, I think I know where you're going with that. Earlier in the Q&A session, we had a question, and I read through some some market data that excluded our PDN volume, where we still think we're doing 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, giving one of your competitors their back and 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 PDM, 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 in general, as a trend, that's not happening. we think there's actually been the opposite. We've got a little bit of an updraft in our back and leg pain growth due to PDM.

Okay, that's helpful. And then I guess just around the, you know, within I guess SDS 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, 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. Yes, I'll take that.

So, you know, we continue to price our products at a premium and are happy with the market. the pricing in our products and our sales channels 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 100, 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 mixed shift of site of care from hospital to ASCs, and we've seen that throughout the the pandemic and ASCs typically bring a little bit lower a 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 your questions. Next, we'll go to Margaret Kekzer with William Blair. Your line is now open.

Hey, guys. This is Maggie Bowie on for Margaret today. Thanks for taking our questions. I wanted to start just digging in deeper to the core STS market. So, you know, as you think about the future and what growth could look like, and obviously can appreciate that'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, you know, included in those assumptions, what are you assuming for potential new entrance 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 NSVP 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 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 this is a follow-up. You know, obviously, you're a year 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, you know, with the rate it's growing right now, hard to parse out, but wanted to see what you guys are thinking about that.

Yeah. I mean, we've tried to quantify the addressable market opportunity before, and I don't think that's changed. You know, 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 is 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 when we're giving guidance for 23 we'll be in a better position to to to talk maybe a little bit more about where we think the total market is going uh over time which is a little bit early for us to do that now um other than just to say we're we're pretty happy with the way it's going and it certainly is ahead of our of our plans got it thank you

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

Okay. Thanks, everyone, for joining us. We appreciate it. 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.