Good afternoon. My name is Erica, and I will be your conference operator today. At this time, I would like to welcome everyone to Nevro's Third Quarter 2022 Financial Results Conference Call. [Operator Instructions]. Thank you. I would now like to turn the call over to Julie Dewey for introductory remarks. Please go ahead..

Good afternoon, and welcome to Nevro's Third 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 third quarter business results from Keith, followed by detailed financials and guidance from Rod, and then we will open up the call for questions.

Please note, there are also slides available related to our third quarter performance on the Nevro Investor Relations website on the Events and Presentations page. Earlier today, Nevro released its financial results for the third quarter ended September 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 November 2, 2022, and an archived copy of this webcast will be available on our Investor Relations 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 will 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 noncash 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 it's my pleasure to turn the call over to Keith..

Thanks, Julie, and good afternoon, everyone. Thanks for joining us. I'll focus my comments today on our third quarter results, the current state of our business and recovery, the progress of our PDN launch, and of course, our recent FDA approval and limited release of our new HFXiQ system.

And following my comments, as Julie said, Rob will cover the specifics of our Q3 results and our guidance. Overall, we continued to move our business forward in Q3 despite a challenging environment for our customers as well as macro impacts like currency exchange rates, inflation, and supply chain pressures.

Our revenue was at the high end of our guidance. U.S. procedure growth rates were well into double digits. PDN revenue growth exceeded our expectations again and adjusted EBITDA results were above the high end of our guidance.

Although we continue to experience the lingering impact of customer staffing and capacity issues, these began to improve slightly during the quarter as we continue to see a gradual overall trend of SCS market recovery, which we do expect to continue in the fourth quarter and throughout 2023.

There were a number of encouraging elements of our progress in the third quarter. Global constant currency revenue was 10% ahead of prior year. U.S. trial activity, our best leading indicator of future growth, delivered 16% year-over-year growth.

Based on a recent refresh of claims data for procedures as well as all reported revenues thus far, we do believe that we continued to gain market share in Q3 as well. We're also extremely encouraged by the progress of our PDN launch, and we believe we've started to build some early interest with our indication to treat nonsurgical back pain patients.

And finally, with the recent FDA approval of our new HFXiQ system, we added a highly differentiated SCS platform, the first and only SCS system that uses truly big data and artificial intelligence to optimize and maintain pain relief using each patient's individual responses.

I'll cover iQ in more detail later in my remarks, but this is an exciting achievement for our company. It's been years in the works. And we believe this is one of the most important launches in Nevro's history.

All of this progress further differentiates our high-frequency, paresthesia-free SCS technology, and we're confident that we're well positioned coming into 2023. Our research confirms to us that patient willingness to engage has improved considerably.

And importantly, the underlying fundamentals of the addressable market and the opportunity for attractive growth rate remains intact.

Based on this and the trend we're seeing in our own trial procedures, we believe the SCS market is moving closer to recovery and is positioned to return to more attractive revenue growth rates as the funnel of trial procedures continues to refill.

In our most recent market research, 1/3 of patients mentioned that their pain physician had canceled or rescheduled an appointment in the last 6 months, with the majority of these due to availability or scheduling challenges.

However, 80% of patients who had no specialist appointments in 2021 at all, tell us they either have an appointment scheduled or already had at least an appointment so far in 2022.

Of course, lingering staffing issues and capacity congestion do continue to put pressure on the scheduling of procedures, but these also began to improve a little during the quarter.

Our trial to perm or T2P conversion curve, which is the average time to convert patient trials to perms, and therefore, revenue, also improved just slightly in the quarter. While our T2P curve is not back to its historical level yet, we expect it to continue to improve during the remainder of this year and '23.

Our guidance that Rob will discuss takes this into account and implies year-over-year revenue growth for the fourth quarter of 9% to 13% on a constant currency basis. Our research makes it very clear that patient engagement and inflow coming into the pain practices is very high right now.

And once the market's capacity to handle pre-COVID volumes is more fully restored, we expect to see market growth return to historical CAGRs. One of our competitors made a recent comment about prior authorization pressures from payers becoming a much more significant headwind for SCS in the third quarter. This is not something we saw.

Medicare and commercial payers reimburse almost universally for SCS therapy. And the payment amounts themselves for both facilities and physicians have remained reasonably stable and appropriate over time.

Now, it is true that prior authorization requirements have been enforced more rigidly in recent years, even if those prior auth requirements themselves haven't changed, though we didn't see a meaningful change inside of Q3. When prior auth requests or appeals are documented correctly, approval rates actually remain high.

As you know, we have a dedicated HFX access team to help manage this effort for our customers and our patients. In fact, about 1/3 of all of our patients come through our access team, and that number is growing.

For those patients, we have an 80% to 85% prior auth approval rate for all trial patients and well over a 90% approval rate for perm patients following a successful trial.

Turning now to our PDN business, at the end of September, we received the positive recommendation of our proprietary high-frequency therapy for PDN by the American Association of Clinical Endocrinology or AACE. Nevro's HFX therapy is the only form of SCS therapy to be referenced in its 2022 diabetes clinical practice guideline to treat PDN.

This update is notable in our view because, one, the professional society guidelines play, of course, an important role to help guide clinical practice. Two, AACE is highly regarded within the diabetes treatment community. And three, the AACE guideline document specifically references our high-frequency therapy as well as our Senza PDN data.

To be included in the clinical guidelines of an influential society in the first full year of approval is unusual, and it speaks to both the needs of these patients and the quality of our data and our outcomes. We're also really pleased with our PDN performance.

Our PDN launch initiatives are driving greater awareness and we continue to make strides in expanding payer coverage for these patients to significantly increase access to the therapy. During the quarter, PDN trials in the U.S. grew 22% sequentially over Q2. PDN trials represented approximately 18% of our total U.S. trial volume.

That's up from 14% of our U.S. trial volume in Q2 and that improved throughout the course of the quarter. Among our permanent implant procedures, PDN represented 13% of our total worldwide procedures, resulting in approximately $13.4 million in PDN revenue. That's an increase of 21% sequentially compared to $11 million in Q2.

As of the end of September, approximately 2/3 of Nevro implanting physicians had received one or more PDN patient referrals, which we attribute to our salesforce expansion that was completed in June as well as our outreach initiatives with both physicians and patients.

Further up the patient demand funnel, we continue to invest in and strengthen our DTC campaign in order to acquire and activate qualified PDN patients. In the month of September, 19% of our U.S. PDN trial procedures came from these DTC patient leads, which was an all-time high.

And we're testing new media channels and programs to continue to strengthen our DTC campaigns going forward. We continue to make impressive progress in expanding payer coverage for our PDN patients.

With the recent positive payer coverage decision by Aetna and several of the Blue's plans, our positive policy coverage now stands at approximately 54% of the U.S. PDN patient population.

In addition, the 2 remaining regional Medicare MACs, Novitas and First Coast, have proposed updated coverage criteria to include PDN for SCS devices with an explicit FDA approval to treat PDN as well.

If finalized, this will mean that Medicare and Medicare Advantage beneficiaries in all 50 states will have access to SCS for PDN, adding approximately 17 million covered Medicare lives and bringing coverage in the U.S. to approximately 66% of PDN patients.

Many of you know that the lag for med tech innovation between FDA approval and meaningful payer coverage, or the valley of death as it's often called, is something that typically takes years to get through. To be at 2/3 of covered lives at the end of the first full year, I think, is really pretty remarkable.

In addition to these coverage policy decisions, we continue to see a high level of patient coverage on a case-by-case basis through the prior authorization process and the appeal of payer denials, including with payers who don't have a positive PDN coverage policy.

For PDN cases that have come through our own access group, our cumulative approval rate as of the end of September continued to trend at or above 80%, and that was up from about 62% at the end of last year.

Finally, we submitted a complete 24-month PDN dataset for presentation at NANS in January of '23, and we plan to see the data published soon thereafter.

We've revised our '22 sales guidance to now include a $45 million to $47 million contribution from PDN and that's up from our original guidance of $25 million to $30 million at the beginning of this year. We're growing increasingly enthusiastic about the potential of the PDN market.

In fact, I don't think any of us would be surprised if in the next 5 years, the total PDN market represents say something like 1/3 of the U.S. SCS market.

Moving on to nonsurgical back pain, after receiving FDA approval of this indication in January, we began commercial activities to expand access to HFX therapy for this patient population by focusing on the identification and education of patients already at existing pain practices who have not had prior surgery and who are not a candidate for surgery.

This strategy is beginning to bear fruit as many of our customers are holding educational events to engage this patient group, which we expect to positively impact trial rates in the future. As we previously announced, UnitedHealthcare released an update to its medical coverage policy and added language to exclude coverage for NSBP patients.

This policy becomes effective on December 1 of this year. All other elements of their SCS coverage policy remained as they were before, including their early decision to cover the use of SCS for PDN.

Although United previously had no coverage policy in place for these patients, keep in mind there were United NSBP cases getting both approved and denied before this change, and that will continue to be the case moving forward on an individual patient basis depending on a patient's unique clinical history and medical necessity.

We do not expect this coverage decision to have a material impact on our go-forward revenue, as we've said previously.

We view these decisions as a very normal part of the market access pathway for new products and patient indications, and we believe our continued generation of high-quality clinical evidence will ultimately carry the day, just as it has thus far with the PDN indication.

Unlike PDN, we've always viewed the NSBP patient population as sort of a rising tide for the entire SCS industry and pain specialty. As our competitors join us in the generation of NSBP data, we believe more payers will continue to cover SCS therapy for these patients who have exhausted all other options for which they are candidates.

Now I'd like to turn to our new Senza HFXiQ system. At the beginning of October, we were thrilled to announce FDA approval of iQ, the first AI-based spinal cord stimulation system that gets smarter over time by learning from each patient's pain experience and responses.

Powered by over a decade of big data from our HFX Cloud patient database, iQ utilizes our smart HFX algorithm for patient programming and our superior high-frequency therapy platform, which has been proven of course in clinical trials and is further supported by real-world evidence for more than 90,000 implanted patients.

We expect this launch to support our growth prospects in '23 and well beyond. There are important reasons why we're so excited about this platform. iQ is designed to improve the consistency of pain relief. Pain is obviously something that's very personal. Every patient and every patient's pain experience is different, and it changes over time.

iQ uses our HFX algorithm, which is based on over 20 million datapoints from over 80,000 patients, to start patients on the stimulation program most likely to provide relief. Then it recommends personalized programming adjustments based on how patients themselves perceive their own pain to optimize and maintain that relief.

This combination of AI and direct patient input is intended to produce continuous relief on an individualized basis, giving patients their desired control over their pain relief based on their personal experience, and to move the patient as needed much more quickly through our programming algorithm without clinician or Nevro representative intervention.

We believe this will lessen the burden on our patients, our customers, and our field and support infrastructure. In an iQ patient interface clinical study that we ran that supported our FDA submission, we found that 87% of patients reported moderately to a great deal better improvement in symptoms.

92% of patients preferred using a digital patient interface to adjust their therapy than more frequent programming calls or visits from the doctor -- or to the doctor. 82% of patients were satisfied or very satisfied with using the patient interface for making therapy adjustments.

Finally, iQ is digitally enabled, so it easily allows for future updates to our algorithm and new features and capabilities, by the way, that are already in development for both patients and our providers.

Since our iQ approval announcement, we've fielded a few questions and seen some attempts by a couple of our analysts to compare what we're doing with the low-frequency ECAPs closed-loop systems a couple of our competitors have been talking about for some time.

To the extent that there is any confusion on this point, let me try to clarify here as they're really not at all the same things. ECAP closed loop is intended to fix one of the primary problems of 40-year-old low-frequency paresthesia technology.

That is the variability of the therapy that causes uncomfortable shocks in one moment and a complete absence of therapy in the next. Even when closed-loop ECAP sensing does correct for that problem, you're left with traditional low-frequency paresthesia therapy, something our field has been moving away from now for the last 7 years.

ECAPs is not closing the loop of a clinical endpoint say like pain, or in the case of CGM-based insulin delivery, blood glucose levels. It's merely adjusting amplitude up or down to maintain paresthesia intensity. Our high-frequency therapy doesn't generate ECAPs by design and doesn't rely on paresthesia at all by design.

It doesn't have this problem, and therefore, it doesn't require this corrective fix.

Instead, iQ takes real clinical endpoints, like the patient's daily input regarding their pain relief and pain score, into account along with quality-of-life inputs such as changes in activity and medication levels, and it combines this with insights from our big data, something no other SCS competitor has, to recommend the next programming adjustment to the patient.

This capability, combined with our superior high-frequency therapy is a far more powerful and personalized approach to actual pain relief, and that is what differentiates the iQ platform. Remember also that in our landmark Senza-RCT at our first approval, we used our HFX10K therapy controlled against a competitor's low-frequency paresthesia therapy.

The size of the treatment effect in that study, in other words the difference between responder rates in the test arm and the control arm, for back pain was almost 41%. The light pain responder rates were also markedly improved.

In our competitor's ECAP study, the treatment effect or difference in responder rate between study arms was only about 18% for back pain with no statistically significant benefit at all for leg pain. We're convinced that combining our already proven high-frequency therapy with a new iQ approach is going to be a really exciting way to treat patients.

Now, our limited release of iQ in the U.S. is underway, and we've already successfully completed our first cases. We anticipate a full U.S. launch in early '23. In addition to the U.S. approval for iQ, we've already submitted for approval in Europe and we'll be submitting for Australia approval soon.

In summary, HFXiQ reflects our continued commitment to deliver comprehensive, life-changing solutions for patients with chronic pain, and it comes at an exciting time as we're closing in on 100,000 implanted patients later this year. We believe that what we're doing with iQ is the future of SCS therapy.

We look forward to leading the path to smart pain management that brings truly personalized relief to patients who need it most. In closing, we made what we thought was very encouraging progress in the third quarter.

We're seeing the start of what we believe will be continued recovery in our markets as well as cause for excitement in our new iQ platform and our other emerging growth drivers.

It's been a tough 2.5 years or so for our therapy, our market, and our company, but it feels like we're in the very early innings of an interesting stage of recovery, innovation and growth. And with that, I'll pass the call over to Rod to provide further details on our third quarter results and on our guidance..

Thanks, Keith, and good afternoon. I'll begin with our worldwide revenue for the third quarter of 2022, which was $100.5 million, an increase of 8% as reported and 10% on a constant currency basis compared to $93.2 million in the third quarter of 2021.

PDN represented 13% of worldwide permanent implant procedures, which resulted in approximately $13.4 million in revenue in the third quarter of 2022. Our Q3 results included approximately $500,000 of impact due to Hurricane Ian in Florida. As a reminder, this quarter included the same number of selling days as Q3 2021. U.S.

revenue in the third quarter of 2022 was $86.1 million, an increase of 10% compared to $78.1 million in the third quarter of 2021. Earlier, Keith mentioned Q3 U.S. permanent implants increased 16%. The gap between the permanent implant growth and the U.S.

revenue growth is primarily due to institutional customers utilizing more than they purchased in order to keep tighter inventory levels, and a smaller portion of the gap is due to a typical pricing decline late in the product lifecycle.

International revenue was $14.3 million, a decrease of 5% as reported but an increase of 8% constant currency compared to $15.2 million in the third quarter of 2021. International revenue, particularly in the United Kingdom, continued to be impacted by COVID-related issues and foreign currency headwinds.

Now let's move on to some detail below the topline. Gross profit for the third quarter of 2022 was $69.3 million, an increase of 7% compared to $64.6 million in the third quarter of 2021. Gross margin was 69.0% in the third quarter of 2022 compared to 69.3% in the third quarter of 2021.

We were pleased that the FDA approved our global manufacturing operations in Costa Rica, which will support our pipeline of future products to ensure that we have the most efficient cost structure and flexible capacity while maintaining the highest level of quality control as we scale.

Operating expenses for the third quarter of 2022 were $92.2 million, which excludes $105 million of litigation-related credits. Including these credits, GAAP operating expenses were a net gain of $12.8 million.

Operating expenses were $91.1 million in the third quarter of 2021, which excludes a $20 million preliminary judgment against the company in that period. Including that judgment, GAAP operating expenses were $111.1 million.

So, excluding the gains and losses from the litigation judgment and settlement, total operating expenses for the quarter were up just over 1% from prior year. The increase was primarily related to personnel-related costs, partially offset by lower litigation fees and marketing initiatives.

Litigation-related legal expenses were $1.9 million for the third quarter of 2022 compared to $6.5 million in the third quarter of 2021.

Net income from operations for the third quarter of 2022 was $82.1 million or a loss of $22.9 million, excluding the $105 million of litigation-related credits compared to a loss of $46.4 million or $26.4 million excluding the $20 million litigation judgment in the third quarter of 2021.

Non-GAAP adjusted EBITDA for the third quarter of 2022 was a loss of $3.8 million compared to a loss of $6 million in the third quarter of 2021. Cash, cash equivalents and short-term investments totaled $386.9 million as of September 30, 2022.

This represents an increase during the third quarter of $76.1 million, primarily due to receiving the cash payment of $85 million related to the settlement agreement that was reached on ongoing intellectual property litigations with Boston Scientific.

We continue to manage our working capital and are comfortable with our balance sheet to fund operations. Turning now 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 this guidance in the future. Earlier, Keith mentioned that the trial to perm conversion curve has improved just slightly, but it is still slower than historical norms.

In Q3, despite some improvement, we saw an impact of approximately $1.5 million due to this length in trial to perm curve. Our guidance assumes that this trial to perm curve remains at current levels for the balance of the year and doesn't improve or worsen.

We have narrowed our worldwide revenue guidance range for full year 2022 to approximately $403 million to $407 million from $400 million to $410 million previously, which implies growth of 4% to 5% over the prior year and growth in the fourth quarter of 8% to 11%.

Assuming foreign currency exchange rates hold at current levels, this guidance includes a negative currency impact for the fourth quarter of approximately $1.9 million versus prior year. This translates to full year growth of 5% to 6% and fourth quarter growth of 9% to 13%, both on a constant currency basis.

Our guidance now assumes $45 million to $47 million in PDN revenue in 2022, an increase from our previous PDN guidance of $42 million to $45 million.

This guidance assumes Q4 will continue to see a steady recovery 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 for the remainder of the year.

We are also updating our full year 2022 non-GAAP adjusted EBITDA guidance to be a loss of $20 million to $22 million, which compares to previous guidance of a loss of $19 million to $25 million and a non-GAAP adjusted EBITDA loss of $17.2 million in 2021. The last item I'd like to cover is some directional comments on 2023.

As is our normal mode of operation, we expect to provide formal 2023 guidance on our Q4 call in February. Directionally, for next year, we expect normal seasonality, a return to growth in our core market, and continued PDN expansion.

We assume that many of the issues that have plagued us over the last couple of years, such as staffing shortages and pandemic disruptions, will continue to recover throughout 2023 and that no other macro environmental impacts emerge to constrain our market.

In closing, we made good progress in the third quarter and remain on track to drive 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, NSBP and our new HFXiQ platform, 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 brief related follow-up question. You can then rejoin the queue, and if time allows, we will take additional questions. Operator, we're ready for the Q&A instructions..

[Operator Instructions]. Your first question comes from the line of Adam Maeder with Piper Sandler..

This is Simran on for Adam. Maybe just starting off with your Q4 kind of implied guidance with the update, I'm -- so doing the math here, I'm seeing a decline of about low single digits in the core leg and back pain SCS market.

Can you talk a little bit about what's embedded for this part of the business, in particular in Q4? And maybe just elaborate on the lift you're seeing in that trial to perm curve in terms of what we can expect for Q4? And just any color on the exit momentum and kind of that first month of Q4 would be great..

Yes. I can take a first crack at that. This is Rod. Wes, our core business for Q4 is basically flat to down a few points on the quarter. As we mentioned, we had really strong trial performance in Q3. In Q2's call, we had mentioned that the trial to perm curve was, in the first 90 days, was roughly down about 300 basis points from normal.

And we've probably clawed back maybe about half of that. We're seeing a little bit of improvement there, but as we mentioned, we're still modeling it at this slightly depressed level, which does have an impact on Q4.

We're continuing to experience a little bit of pricing pressure as well, which we would expect that that will continue as we primarily stay in limited release on the new product in Q4 as well.

Does that get you what you want?.

Yes, yes. That's great.

And then maybe just a quick follow-up on the -- with the launch of kind of that next gen Senza system, any early feedback from clinicians on the system? Is there anything? And then is there anything from a hardware perspective that changed in the new IPG, or is it really just kind of this addition of that iQ algorithm and software? And then also any thoughts on pricing.

Sorry, that was a lot..

Yes. This is Keith. It's an entirely new system. It's a new IPG. It's a new patient control app. It's a new remote. It's a new programmer. And obviously, it's entirely new software and firmware. It's very much a new system with new componentry at every level.

From a pricing standpoint, we haven't been -- I think we want to get through the LMR here in the fourth quarter. It's not a secret that we typically rely on refreshing the product lifecycle on new innovation to maintain and increase ASPs at the beginning of the lifecycle. And you can assume that that would be our intent here as well.

In terms of customer feedback, we have -- we just started the limited market release. I think we're probably a half a dozen patients in or so, so anything I tell you or am about to tell you is entirely anecdotal. But the response from both doctors and patients has been overwhelmingly positive. It really has gone well.

It's very early, very little -- very small ends so far, but the response to the feature set, the capabilities on both the part of the patient and the doctor, is very similar to what we saw in our early user interface trial while we were in development of this product. I think the team is super excited about what we're seeing..

Your next question comes from the line of Joanne Wuensch with Citibank..

I want to spend a little bit more time on iQ, please. A few questions.

When do you anticipate going into full market release? Do you at some stage anticipate it being the only product that you're selling or will you use it to bifurcate the market or to curate into different products for different segments? And can we assume there is a pricing premium to iQ which might help either on a peer basis or overcome pricing headwinds?.

Yes. Thanks, Joanne. Again, I don't want to get into too much detail until we're ready to execute on our full launch. But no, we're not -- we don't expect this to be the only product.

I would expect relatively fulsome conversion to this product just based on the capabilities and the uniqueness of what patients and doctors can do with this platform, but it won't necessarily replace, for example, Omnia. We'll continue to offer multiple products in the product line. I won't get into detail on the pricing.

But yes, the capability set here is pretty dramatically different, and so we would expect to see at least some pricing premium in the market for this product..

And my second question has to do with PDN, surprising. Quite the ramps there, and since we're all really fine-tuning our 2023 models, how do you think about where you go from here over the next 12 months? And thank you for taking the question..

Well, great question. Also, a tough one for us to answer now in the absence of guidance. We'll be much more granular in our description of that in Q1. But our expectations are -- I mean we want to continue to be realistic here about the challenge of developing a new market and about the work that we have ahead of us.

But I would say the enthusiasm gets a little higher every quarter. And to go sort of from zero to the guidance we've given in the first full year, feels like the beginning of a pretty interesting device market to me. I think our expectations coming into next year are actually going to be pretty strong. I realize that doesn't give you a lot of detail.

We don't have guidance, but we will give you some detail, Joanne, when we talk in February..

Your next question comes from the line of Chris Pasquale with Nephron Research..

Hi, this is Devin on for Chris. Thanks for taking my question. Just wanted to touch on the delta that you mentioned between the 16% U.S. permanent implant growth and the 10% U.S. revenue growth. I think you said that there were pricing headwinds there in institutional customer purchasing.

Just seeing what was kind of the bigger headwind there, and do you expect that gap to be in coming quarters? Then I have one follow-up..

Yes. The larger piece of it was the managing down of inventory by our customers. That was roughly 2/3 to 3/4 of it. We would anticipate a little bit of pricing pressure until we get into the next generation product in the fourth quarter here. And I wouldn't anticipate that sort of usage in the fourth quarter.

Really can't provide any guidance beyond that. And the usage of inventory out in the field, that can be a little bit lumpy from quarter-to-quarter, although we've continued to manage that down directionally over time..

That's helpful. And then just on iQ and the manufacturing facility in Costa Rica, any benefits? I think you alluded to gross margin improvement as far as just ramping up capacity previously in Costa Rica.

But anything on iQ as well with the new remote and system componentry, whether you could see a COGS line impact there?.

Sure, I'll take that. We actually will be manufacturing the majority of our new products out of Costa Rica. And we anticipate margin expansion from a cost reduction in almost all of those lines..

I would say if you're looking for specific cost advantages from a product-to-product standpoint, it's really more about site of manufacturing than it is the specific product design.

I do think that we expect over time some business model efficiencies with this product capability set in terms of the number of people that we require today to work with our patients directly and the number that we think we'll need as more of our patients are put on the iQ system where so much of that is going to be automated..

Your next question comes from the line of Larry Biegelsen with Wells Fargo..

Hi, this is Nathan Treybeck on for Larry. Thank you for taking the question. I wanted to touch on the United NSRBP decision.

I guess why do you think the decision came soon after the study that you did? Is there any chance of reversing this decision in the likelihood that other payers will follow United's decision?.

Well, look, we don't have a lot of color. They don't typically meet with suppliers to describe what they're planning to do or why they've done what they've already done. We don't have a lot of information behind the scenes. I think we were the first ones to get an explicit FDA indication for this.

It probably prompted a review of their coverage policy to make sure that their policy covered it explicitly one way or another. Why they went one way on PDN and another on NSBP is a little difficult for us to define. But I would say that is it capable for -- is it possible that these get changed over time? Of course. They get changed all the time.

They may want to see 24-month published data. They may want to see a second study. They may just want some time to see what patient and doctor demand is and how patients are presented to them in the field. It could be lots of things. But commercial payers change their policy decisions all the time.

They were very quick to give us a positive coverage inclusion for PDN based on the data. And we're not really entirely sure why they made a different decision with NSBP. Look, I will say that with PDN, this is a patient population with no other alternatives. Extremely needy, very expensive for the payers, and we generated phenomenal data.

In the case of NSBP, there may be payers who are used to an expectation that SCS be at the end of a patient care pathway. And just this very notion that we're treating patients who haven't gotten surgery may take them some time to digest.

Even though these patients are not candidates for surgery, it does feel to some patients, or rather to some payers, like a little bit of a change in the patient care algorithm and SCS, their position within that algorithm. I think, look, I just think it's going to take some time. I don't think this is that unusual.

And I think we'll get it reversed over time, to be honest..

Great. Thank you for that. In terms of PDN, what have you seen from Medtronic in the market following its approval? And I guess, you've been in the market about for a year now with your PDN indication.

How might you tweak your strategy going forward?.

Well, we'll certainly tweak our strategy going forward. I mean I don't know that it will be directly related to what Medtronic has done or will do. We have seen a little bit more of Medtronic in the field. I don't think that's a surprise to us. They've got a smaller group than we do I think calling on referral doctors, about half the size.

We see them occasionally in some of the referring doctors. We see them at scientific conventions and tradeshows talking about PDN now. We haven't seen -- we're not sure what they're doing on a direct-to-consumer, direct-to-patient basis. I assume they must be doing something. I don't think they're doing a lot or we would have seen more of it.

And we haven't seen a lot of volume. I suspect most of their volume, and we don't know what it is because they don't carve it out, I suspect the majority of it is inside of their own customers, particularly their own large and loyal customers. I don't think there would be a lot that we would change because of that.

We will look to refine our strategies. We've added more people to the PDN referral group. We're evaluating right now maybe a further expansion of that referral group because we really like the way it's working and performing. We've refined a lot of what we do on a DTC basis and made some changes.

And we're evaluating some things right now through more traditional mass media channels in certain markets, and we may phase some of that work into our nationwide DTC work as well. That will continue to change and be refined over time just on its own..

Your next question comes from the line of Brandon Vazquez with William Blair..

Keith, I actually wanted to kind of follow up on the last part of what you were just talking about there within PDN. And I'll lump 2 related questions into one here on PDN. The first one being, you've had a lot of nice wins, whether it's reimbursement, market access or society guidelines.

How do you invest within the field to make sure that both patients and clinicians are aware of these wins to kind of help get patients into the funnel and then physicians aware of that? And then the follow-up was kind of what you were referring to earlier.

What do you invest in today? Maybe you can give a little bit more color on some of those changes that you alluded to. What are you investing today to make sure that PDN continues the momentum it's seen as you go through 2023 and even beyond? Thanks..

Sure. I don't want to be too redundant. I think from a communication standpoint, it's a good question. We have had a lot of wins. We have a pretty reasonably sized footprint of personnel in the field, I think in the neighborhood of 500 or so in the U.S., with all of our groups combined.

We have a reasonably large megaphone to particularly our core customer base through both our field team and through other mechanisms by which we communicate with them. In the case of referring doctors, we do that through our referring salesforce through direct digital means that go to the doctors and not just the patients.

And through our work with the societies, both our work with their leadership and our work with their membership on conventions and tradeshows and that kind of thing. We have lots of ways we get the word out on these wins. I don't think there's any of them that are still a good secret. Certainly, they shouldn't be.

In terms of changes to our strategy, I think I've already mentioned that. I think the 2 that I would look to hear from us on in the relatively near future would be expansion of our referral activities in the field and expansion and refinement and change of tactics in our DTC initiatives to mostly to patients, although some to referring doctors.

Look, there's lots of other things that we can do that we think help establish our leadership in PDN. And of course, right up there at the top, are clinical outcomes. We generated some pretty phenomenal outcomes in our Senza PDN trial.

We are already in the process of starting up 2 additional trials, a post-market trial and we'll be shortly starting a separate trial looking at sensory relief. You might recall that in our first publication, we said that we saw sensory relief in 2/3 of our patients.

That was an outcome that raised a lot of eyebrows, particularly among the referring audience. We're going to try to put a finer point on that with that as a primary endpoint in a subsequent trial. There's a lot we're doing. We're even looking at product refinements that might be specialized.

For example, in the iQ product, there is an iQ mode that the patient can select for PDN specifically, that we think is going to be very important for these patients. We'll continue to build around this franchise in I think a very meaningful way. But at the very center of it will be better outcomes..

Your next question comes from the line of Robbie Marcus with JPMorgan..

I wanted to circle back to the guidance because I imagine you put out that framework to help direct buy-side and sell-side models. And maybe just to make sure we're all getting the message, Street said something like 450, 500 for next year, about 12% sales growth.

I think most models have something like $75 million to $80 million in PDN, which implies something like 5%, 6% growth in the base business in the U.S.

I mean, is that sort of the gradual return that you're talking about? Or are you trying to signal us something a little lower than that? Because I look at the numbers and year-to-date has been kind of down mid to high single digits versus 2019. Fourth quarter implies flat versus 2019 on non-PDN volumes..

Robbie, I know you can script the first part of my answer here, which is we didn't give quantitative guidance. We don't have it in place for next year, and so I don't want to do it on an ad hoc basis. I will tell you that our intent, yes, as a general framework, what you're describing is the way we're thinking about things.

And our intent is not to bring guidance or expectations down from the range you just mentioned for next year..

I mean, that is actually very helpful because I'm sure you put it out there for a reason. Less important, but still not an insignificant number, is the international business, and it gets a lot less attention.

How are you doing in that business? Do you think you're gaining share? Do you think the market's growing similar, better, worse than the U.S.? And how do you think about your position there going forward? Thanks a lot..

Yes. It's interesting. I think the international market is in every medical device, every therapeutic category, is a little bit different. I think you're right, we don't talk about it as much and neither do our competitors because it is a smaller part of this market. It's probably between 15% and 20% of the total global market.

It doesn't mean it's unimportant by a long stretch.

But I think the growth rates in international right now have been a little bit challenged because the core markets have, and one in particular, and that's the U.K., have just been very dramatically impacted by the pandemic environment and the recovery there has just simply been a lot slower than other markets.

And that is one of our 3 most important OUS markets. Now on the other hand, in Australia, we did struggle through the pandemic. And then more recently, Australia has done much better. It really depends -- and I'd say that's true to a large extent in Germany. It really depends on the market.

In general, from a share standpoint, we've been in those markets longer than we've been in the U.S. We were there a few years or so, I think 2 or 3 years before the U.S. market. We've got some pretty strong shares in some of our markets.

I think in Australia, we're -- I don't want to speak out of turn with too much precision here because I don't want to be wrong, but we're somewhere in excess of 40%, and we are the number one market shareholder in Australia, and we're somewhere between 40% and 50% right now.

And that fluctuates more in that market than I think others, but that's where we believe we are right now. It really does depend. Our shares are pretty good, but market recovery from the pandemic has been more mixed and probably more muted..

Your next question comes from the line of Rich Newitter with Truist Securities..

This is Dave Rescott on for Rich. Thanks for taking the questions. I want to start off and first just kind of follow up a little bit on some of the prior comments you made about 2023. I think in the earlier part of the call, you had mentioned that you ultimately expect the U.S. SCS, the core SCS business, to return back towards historical growth CAGRs.

Just wondering, there's been times when growth was pretty decent in the market and not so decent, so I'm just wondering what you're referring to when you're talking about getting back to those historical CAGRs.

And then looking out to 2023, does the market next year get back to that historical growth CAGR? And if so, I guess how much of the new launch from HFXiQ is accounted for in that kind of growth for next year?.

Yes. We've spoken I think as recently as maybe last quarter or the quarter before about a couple of different ways of looking at historical market CAGRs.

I don't have those numbers in front of me, but I can -- I know that in general, if you look out over the last, depending on the timeframe you choose, 5 to 15 years, CAGRs in this market have tended to cluster on average in the mid to upper single digits. They've sometimes gone to low single digits.

They have sometimes gone into the low or even mid-teens. But over a long period of time, they seem to have clustered in the mid to high single digits. When we talk about reversion back to historic CAGRs, I think that's kind of the range we have in mind. Now I think, look, some of these recovering indicators are going to be playing out through '23.

Is the market growth rate going to be 9% or 10% in '23? Or is it going to be closer to the lower end of mid to high single? I would say I probably personally would err towards the lower end of that, but that would just be in '23 as we kind of work through some of the remaining issues here. Now, Nevro's growth in the core market is a different story.

We believe we will continue to gain share. We think that would happen with our therapy over time anyway. I think that iQ will be an accelerator to that, and so we would expect to do a little better than the market, whatever it is, in the core market in 2023. And I hope certainly well beyond that, but certainly in '23.

Does that all help?.

Yes, that's very helpful. Thank you. I guess a second on PDN, I think you mentioned around 2/3 of the implanting physicians have received at least one or more referrals. Just wondering if you could comment on maybe some of the stickiness within the PDN within some of these physicians' practices.

I guess how many of these accounts are actually translating to implanting a PDN device? And within maybe some of those accounts that are actually doing PDN, how many of them are seeing 1 or 2 implants or doing multiple implants within the quarter? Thank you..

Yes. I think between 40% and 50% of all of our accounts now have already done at least 1 trial. To give you a sense, you would expect experience with trials to lag and follow behind the leads and then firms to lag behind trials. But that kind of gives you a sense of the magnitude of exposure.

I can't think of one pain practice, one doctor that I've talked to in the last 15, 16 months, whatever it's been since approval, that has told me they don't want to treat these patients. I don't think it's a matter of some want to be in PDN and some don't. I think it's just there are so many referring doctors out there. We're rolling this out.

It's a brand-new therapy. We're talking about it to a reasonably inexperienced and uneducated referral base on this therapy for these patients. And so predictably it takes the kind of time that it's taking, but it's moving in the right direction every single quarter.

And I would expect over the next 2, 3 quarters, the percentage of our customers that have done a PDN case is going to continue to grow pretty meaningfully over the next year..

Your next question comes from the line of David Turkaly with JMP Securities..

I'll try to combine two into one here. I'm just trying to wrap my head around the prior auth commentary from the competitor.

And I just was wondering, have you at a time seen a blip or a significant blip like that in a quarter or a frame, timeframe like that that you called out, whether it was positive or negative? And in your view, could this be related to like a specific company or a specific therapy? I'd just love to get your thoughts on why that comment may have been made and if you've ever seen anything similar?.

I have no idea. And we normally wouldn't call something like that out other than the fact that it was just mentioned in our competitor's call. And it would have been kind of silly not to respond.

To answer your question, no, I've never seen a -- there's a lot of commercial payers in a lot of regions with a lot of plans, and you've got different government coverage plans. It would be very unusual to see something show up, a blip as you called it, in a trend in coverage in one quarter.

I don't know that we've ever seen something change that dramatically across all payers. And in fact, we didn't see that in Q3. Now, it is an issue. And the payers are -- while they've got good coverage in place, they raise their payment rate terms almost every year.

Where they do exercise some pressure on the market, like by the way, a lot of other therapies and codes, is in the exacting nature that they require prior authorizations to be completed. I would say that in the last 2, 3 years, our customers have seen more and more pressure from payers saying, hey, you need to document that they've already done this.

We don't see that the patient has tried this therapy. Have they been on meds for the right number of months? There's a lot of pushbacks to check the boxes and do it all the right way. But once the patients meet the criteria, we've seen no change and no difference in patients getting approved.

Having said all that, even with recognizing that long-term pressure on prior authorizations that I think a lot of people have seen, there was no difference between Q3 and say Q2 that we saw in our customers' practices or in our results..

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

Thank you, everyone, for joining us. And if you have any questions, need more information, you obviously know where to find us. We look forward to giving you an update next quarter..

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