Nevro - Q4 2022

Transcript

Speaker 0

Afternoon. My name is Brent, and I will be your conference operator today. At this time, I would like to welcome everyone to Nevro's 4th Quarter 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Thank you. I would now like to turn the call over to Julie Dewey for introductory remarks. Please go ahead.

Speaker 1

Good afternoon, and welcome to Nevro's Q4 and full year 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 4th 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 Q4 performance on the Nevro Investor Relations website on the Events and Presentations page. Earlier today, Nevro released its financial results for the Q4 ended December 31, 2022. A copy of our earnings release is available on our IR section of our website at nevro.com. This call is being broadcast live over the Internet to all interested parties on February 16, 2023, 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 these expressed or implied as a result of certain risks and uncertainties. Please refer to our SEC filings, including our annual report on Form 10 ks to be filed 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 non cash items such as stock based compensation and depreciation and amortization.

Please refer to the GAAP to non GAAP reconciliation tables within our release. And now it's my pleasure to turn the call over to Keith.

Speaker 2

Thank you, Julie, and good afternoon, everyone, and thank you for joining us. I'm going to focus my comments today on our 4th quarter results, the current state of our business and recovery, to the progress of our PDN launch and the limited market release of our new HFX IQ system. Now following my comments, Rod will cover the specifics of our Q4 results in our 2023 Q1 and full year guidance. Overall, we continue to move our business forward in Q4 and we're entering 'twenty three with, I think, some real positive momentum. Our revenue was at the high end of our guidance.

U. S. Procedure growth rates grew double digits And adjusted EBITDA results were within our guidance range, excluding one time charges. I'm really pleased with the building blocks that are now in place for attractive growth and leverage going forward and believe the challenges to our market will gradually but steadily continue to improve throughout 2023 and beyond. There were a number of encouraging elements of our progress in the Q4.

Global revenue growth was 12% over prior year on a constant currency basis, while U. S. Revenue growth came in at 13% and U. S. Trial activity delivered 9% year over year growth.

In fact, October, November December were all time record months for daily trial rates in the U. S. With Q4 U. S. Trials, in fact, about 6% ahead of 2019, which of course was our last pre COVID comparable period.

Based on reported competitive revenues thus far for Q4, we continue to gain market share in the quarter and full year 2022 as well. PDN continues to be a significant driver of growth with impressive performance quarter over quarter throughout 2022. And finally, our new AI powered HFX IQ system is performing really well in our limited market release with positive feedback from physicians and patients regarding the ability to deliver personalized pain relief using our big data backed to HFX Algorithm and more on IQ later in my remarks, but I think this technology really has the opportunity to further differentiate our competitive position in this space. All of this progress builds, of course, on our superior high frequency paresthesia free SCS technology, and we're confident that we're well positioned for 2023. We see continued signs of market recovery as the recent challenges in our market are beginning to recede and we continue to believe that the underlying fundamentals of the addressable market and the opportunity for growth remain largely intact.

We continue to see encouraging growth in trials and permanent implants, and we're starting to see the recovery that we expected to see as the impacts of the pandemic begin to wane. We think by the way that that is going to continue throughout 2023 that we know Though it's unlikely rather to be a linear in nature. Of course, lingering staffing challenges and Capacity congestion do continue to put pressure on the scheduling of procedures, but these also seem to improve a little during the Q4 and we believe this trend will continue throughout 2023 as well. Our guidance takes this into account and implies year over year revenue growth for the Q1 of 9% to 11% on a constant currency basis. Of course, this assumes the typical sequential seasonality we usually see from Q4 to Q1.

Our previous research indicated that patient engagement with pain has been improving. And as the market's capacity to handle pre COVID volumes is more fully restored, we expect to see market growth return over time to historical CAGRs. Turning now to our PDN business. Our progress with referring clinicians, payers and clinical societies to our expectations in 2022, and we're looking forward to continuing to develop this exciting growth platform in 2023. During the quarter, PDN trials represented approximately 20% of our total U.

S. Trial volume. That's up from 18% of our total U. S. Trial volume in Q3 and that actually improved throughout the course of the quarter.

Among our permanent implant procedures, PDN represented around 15% of the total worldwide procedures resulting in approximately $17,300,000 in PDN indication sales, That's an increase of 29% sequentially compared to $13,400,000 in the 3rd quarter, which we attribute in large measure to the PDN referral sales organization expansion that was completed in June as well as our outreach initiatives with both physicians and patients. In the month of December, Approximately 16% of our U. S. PDM trial procedures came from leads generated by our own DTC programs. And we continue to test new direct to patient media channels and programs to drive awareness and interest with patients directly.

In addition to the existing payer coverage policies in place for PDN, we continue to see a high level of case by case approvals through the prior authorization process and the appeal of payer denials, including with payers who don't have a position or rather a positive PDN coverage policy. For those PDN cases that have come through our own access group, our cumulative approval rate as of the end of December continued to trend around 80%, and that was up from about 62% at the end of 2021. Finally, the complete 24 month PDN RCT trial data and the 12 month quality of life RCT data were presented in January at the NANCE conference in 2 separate podium presentations by Doctor. Erica Peterson. These strong results confirmed the long term durability of pain relief as well as clinically meaningful improvement in neurological function and quality of life achieved with 10 kilohertz therapy.

We expect to submit this data in the coming months for publication. In addition, we're also looking forward to enrolling our 1st patient next quarter in our new PDM sensory study, which will be the 1st prospective RCT specifically powered to assess restoration of neurological function as a primary endpoint in patients with intractable PDM. We plan to enroll up to 236 patients at multiple sites across the U. S. Patients will be randomized to conventional medical management or 10 kilohertz SCS plus conventional medical management with optional crossover to the other treatment arm at 6 months if those criteria are met.

This SENSORIC study is groundbreaking really for several reasons. Diabetes and peripheral neuropathy pose a staggering socioeconomic burden. There is no available disease modifying treatment option available for patients with PDN. In fact, every 20 seconds in the U. S, There is a diabetes related amputation according to the American Limb Preservation Society, and many of these amputations are preventable.

Insensei or numb feet contribute to unrecognized injuries and foot ulcers as patients lack protective sensation. Foot ulcer treatment and associated amputation surgeries are costly, both economically and of course psychosocially. By restoring sensation in the feet, 10 ks SCS may alleviate this tremendous disease burden, prevent amputations and enable patients to be more active, all of which would improve overall health and quality of life and of course reduce health care costs. This study also affords a path forward to building clinical evidence for slowing the progression of or improving sensory loss of lower LEMS in patients with chronic intractable pain and builds on the significant outcomes we saw in our landmark 10 kilohertz SCS to RCT with powered study endpoints targeting the disease modifying benefits of improved neurological function in pain relief. You'll recall that the observed neurological improvements we saw in the original SENZA PDN study are unique to 10 ks SCS that have not been reported for any other competitive SCS modality.

Not only do we anticipate that this study will provide additional confirmatory evidence to the benefits of Nevro's proprietary 10 ks therapy in these PDN patients. But we also believe that the additional level 1 data generated will be very helpful We continue to work with payers to expand PDN coverage generally. I'm pleased to announce that the FDA who has granted breakthrough device designation for the PDN SENSORIES study and this potential device indication. This designation by the FDA provides for an expedited review for a marketing application to expand Nevro's FDA labeling. And as I said earlier, we look forward to enrolling our 1st patient next quarter and we're really excited about the opportunity for this target patient group.

Following our strong progress in 2022, PDN is expected to be a significant growth driver for us once again this year. As another example of the growing interest in PDN, as of the end of December, over 70% of Nevro implanting physicians had consulted with 1 or more PDN patients in their practice. Our 2023 revenue guidance includes a $75,000,000 to $85,000,000 contribution from PDM. That's an increase of 56 to 77% over 22%. As we said, over time, we think PDN is going to be one of the more significant parts of spinal cord stimulation, perhaps growing to as much as a third of the U.

S. SCS market. Our guidance for 2023 implies this patient segment will already be about 15% to 20% of our own business in just its 2nd full year. Moving out to non surgical back pain. After receiving FDA approval of this indication last 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.

Unlike PDN, we've always viewed the MSPP patient population as sort of a rising tide for the entire SCS industry and pain specialty. We continue to lead the charge in generating NSPP clinical data, but it was encouraging to see our competitors also begin to report their own data at NANS this year, which helps to build the foundation of clinical evidence supporting this indication. As our competitors continue to 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 their candidates. We believe this will help to grow the market for SCS therapy for back and leg pain patients in the coming years. Speaking of that, our clinical investigators presented positive 2 year follow-up data for our SENSA NSBP trial Adnan, which included clinically important and stable pain relief in patients treated with 10 ks SCS as well as strong durable improvement in reported function in a significant quality of life improvement.

These results were seen in patients with refractory chronic low back pain who were evaluated by a spine surgeon for surgical candidacy and who had exhausted all appropriate non operative medical management. On the reimbursement front, today we've not experienced any noticeable impact on our revenue from UnitedHealthcare's decision to exclude coverage for NSBP patients, which became effective on December 1. We also don't expect this coverage decision to have a material impact on our go forward revenue opportunity as we said previously. And we believe our continued generation of high quality to the FDA, just as it has thus far with the PDN indication. Now I'd like to turn to our NuCensa HFX IQ system.

Following FDA approval last quarter, we initiated a limited U. S. Market release, which has been very well received. IQ is the 1st big data backed AI powered spinal cord stimulation system that gets smarter over time by learning from each patient's pain experience and that patient's interaction with the device and the therapy. IQ is powered by something no other SCS system has, to big data, in fact, over a decade of longitudinal patient data from our HFX Cloud patient database.

Our HFX algorithm, which is based on over 20,000,000 clinical data points from over 80,000 patients in this database drives the IQ product. This algorithm starts patients on the stimulation program most likely to provide relief based on their specific profile. ICUE is Bluetooth enabled and connected to a patient app and learns each patient's individual inputs to personalized therapy recommendations designed to progress the patient along their pain relief journey. This combination of big data, AI and direct patient engagement and input is intended to optimize and maintain pain relief on an individualized basis, giving patients more control over their pain relief based on their personal experience and at a time that suits them. IQ is a powerful supplement to our field team, our HFX coaches and our cloud database that provides physicians with both detailed and summary outcomes data.

We believe the IQ will lessen the burden on our patients and our customers and expect this launch to support our growth prospects in 2023 and well beyond. By the way, the iQ product line is the next logical step in allowing us to drive more profitable growth as it enables our existing team to scale more effectively over a larger base of patients and revenue going forward. I believe this combined with the ramp up of our Costa Rica manufacturing facility is really going to help us with the earnings productivity of our revenue growth in the coming years. At the NANS meeting, we had an opportunity to feature the HFX IQ system at our exhibit booth and several other events, including a well attended physician education lunch. We're preparing for a full U.

S. Launch very soon and expect a meaningful shift in mix to the HFX iQ product throughout the rest of the year. In addition to the U. S. Approval for IQ, we've already submitted for approval in Europe and Australia.

In summary, the HFX IQ reflects our continued commitment to deliver comprehensive life changing solutions for patients with chronic pain and it comes in an exciting time as we've now impacted the lives of more than 1,000 implanted patients globally with our technology. We think what we're doing with the IQ represents the future of SCS therapy, and it keeps Nevro firmly at the forefront of innovation as we continue to bring new technology, new data and new indications to our customers and our patients. We're also very proud to announce that we recently received our certification to the new European regulatory standard for medical device companies known as EU MDR. This certification is a strong validation of the strength of our internal quality management system, and it follows several years of work and preparation by our team. I should mention that only about 25% of the applications received by European notified bodies have undergone regulatory assessment and received a certificate according to this new and more robust regulatory framework.

I'm really pleased that Nevro is among the 1st wave of medical device companies to achieve certification to this new standard. So in closing, we made encouraging progress in the Q4 with what we believe will be continued recovery in our markets, important new products like the HFX IQ platform, entirely new patient populations like PDN and NSBP and the opportunity for attractive operating leverage on future growth as a result of our intense focus on the scalability of our expense structure. I think the outlook for Nevro is increasingly bright. And with that, I'll pass the call over to Rod to provide further details on our Q4 results and on our guidance.

Speaker 3

Thanks, Keith, and good afternoon. I'll begin with our worldwide revenue for the Q4 of 2022, which was $113,800,000 an increase of 11% as reported and 12% on a constant currency basis compared to $102,800,000 in the Q4 of 2021. PDN represented 16% of worldwide permanent implant procedures, which resulted in approximately $17,300,000 in PDN indication sales in the Q4 of 2022. As a reminder, this quarter included one less selling day in Q4 of 2021. U.

S. Revenue in the Q4 of 2022 was 99 $800,000 an increase of 13% compared to $88,400,000 in the Q4 of 2021. International revenue was $14,100,000 a decrease of 2% as reported, but an increase of 9% constant currency compared to $14,300,000 in the Q4 of 2021. Now moving on to some detail below the top line. Gross profit for the Q4 of 2022 was $75,200,000 an increase of 9% compared to $69,100,000 in the Q4 of 2021.

Gross margin was 66.1% in the 4th As Keith said, the limited market release of the HFX IQ system continues to progress well and the company continues to anticipate a full market launch very soon with a meaningful shift in mix to the HFX iQ product following the full market launch. As a result, we recognized charges to cost of goods sold in the Q4 of 2022 of approximately $2,000,000 related to the write off of a portion of our legacy product inventory. Without these charges, Margins would have been 68%. Operating expenses for the Q4 of 2022 were $94,600,000 down 1% compared to $95,300,000 in the Q4 of 2021 and in fact were up less than 2% over the Q4 of to 2019. Litigation related legal expenses were $1,200,000 for the Q4 of 'twenty two compared to a $6,100,000 in the Q4 of 2021.

The company also incurred restructuring charges to commit $300,000 of restructuring charges in the Q1 of 2023. Net loss from operations for the Q4 of '22 was $19,400,000 compared to a loss of $26,200,000 in the Q4 of 2021. Non GAAP adjusted EBITDA for the Q4 of 2022 was a loss of $1,400,000 compared to a loss of $7,500,000 in the Q4 of 2021. Without the $2,000,000 inventory charge, adjusted EBITDA would have finished at a positive $600,000 for the quarter. Cash, cash equivalents and short term investments totaled $374,400,000 as of December 31, 2022.

This represents a decrease during the Q4 of 'twenty two of $12,500,000 We continue to manage our working capital and are very 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 assumes the full year of 2023.

We'll see steady improvement in provider capacity due primarily to a decrease in healthcare facility staffing challenges as well as no changes in macroeconomic factors that would materially impact a patient's willingness or ability to seek elective care. The trial to perm conversion curve has improved just slightly, but it is still a bit slower than historical norms. In Q4, despite the slight improvement, we saw a small impact due to this lengthened trial of the perm curve relative to historical norms. Our guidance assumes that this trial of the Permakr remains at current levels for the balance of the year and doesn't improve or worsen. Given this backdrop, we're guiding the 1st quarter worldwide revenue of approximately $94,000,000 to $96,000,000 which represents 9% to 11% growth on a constant currency basis and reflects the typical seasonal step down in revenue from Q4 to Q1.

All of these market factors related to recovery apply equally to PDN case volumes as well, and we expect PDN to reflect similar Q1 seasonality to the larger SCS market. Thus, PDN indication sales in the Q1 of 2023 are expected to be approximately 15% to 20% below to the Q4 of 2022 and then expected to grow sequentially each quarter for the remainder of 2023 given the strong underlying momentum in this indication. We expect Q1 of 2023 non GAAP adjusted EBITDA to be a loss of approximately $19,000,000 to $20,000,000 As we've seen historically, Q1 experiences a disproportionate amount of annual expenses due to the NANDs conference, our global sales meeting as well as certain other Q1 heavy expenses such as payroll taxes and 401 matching that we set in the new calendar year. This year's Q1 expenses are more in line with our normal Q1 pace as a percent of total spending for the year. They also represent a bigger difference over prior year because of our global sales meeting, robust NAND presence and increased PDN investment.

We do want to point out that current consensus does not reflect the step up in operating expenses that we normally see in Q1. To help you with timing in the second and third quarters of this year, we expect to be at around breakeven from an adjusted EBITDA perspective and moving toward a positive adjusted EBITDA range in the 4th quarter. We continue to expect worldwide revenue for full year 2023 of approximately $445,000,000 to $455,000,000 an increase of 10% 12% over prior year or 10% to 13% on a constant currency basis. This full year 2023 guidance This includes approximately $75,000,000 to $85,000,000 of PDN indication sales, an increase of 50 6% to 77% over prior year. For full year 2023, Gross margin is expected to be approximately 68%.

The Costa Rica manufacturing plant is producing meaningful volumes to date in 2023 and we remain encouraged by the volume potential of production as well as the high quality of and cost reductions in our manufactured products. However, 2023 gross margins will experience some headwinds in the 1st three quarters of the year due to recent pricing increases from some of our contract manufacturers and heavier than anticipated 2023 projected mix of contract manufacturer products. We expect to see improvements in gross margins beginning in Q4 and then believe the Costa Rica facility will deliver gross margin expansion to the mid-seventy percent range over the next 3 to 5 years, assuming no material pricing changes. Operating expenses are expected to be approximately $391,000,000 to $393,000,000 for 2023, including combined litigation expenses and ongoing investment in PDN market development of approximately $40,000,000 We expect full year 2023 non GAAP adjusted EBITDA to be in the range of negative $5,000,000 to negative $10,000,000 which compares to a non GAAP adjusted EBITDA loss of $23,800,000 in 2022. We do want to provide you with the expected cadence of our business to assist you in modeling our quarterly performance during 2023.

We expect high single to double digit constant currency growth for the first half of the year over prior year. The 2 quarters in the back half of the year are expected to grow in mid teens over Q3 and Q4 of 2022 as we assume we will benefit from an improving market environment, to the launch of HFX IQ and continued progress in our PDM business. Finally, I think it's important to review our progress on our journey to drive growth and scale profitably in our core business. For example, let's take a quick look at our operating to the Q1 of 2019. Over the years, operating expenses excluding litigation and PDN have gone from 91% of revenue in 2019 to 84% of revenue in 2022 and are expected to finish 2023 in the high 70s.

Many of the changes we continue to invest in, including our Costa Rica facility and development of the PDN market are designed to provide continued improvement in our financial leverage as we grow. We believe that with these investments, we can create even greater leverage in the coming years. So please keep in mind that even including all of these investments I've just mentioned. Our full year 2023 operating expenses will only be about 7% higher than those in the full year 2019. In closing, we made good progress in the Q4 and remain on track to to drive growth and scale profitably in our core business in the years ahead.

We are in a great position strategically with best in class SCS technologies, remaining share gain opportunity, future growth opportunities in PDN, NSBP and our new HFX IQ 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 and A session.

Speaker 1

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 one brief related follow-up question. You can then rejoin the queue and if time allows, we'll take additional questions. Operator, we're ready for the Q and A instructions.

Speaker 0

Your first question comes from Joanne Wuensch with Citibank. Your line is open.

Speaker 1

Thank you for taking the questions. I'm a little bit curious about a couple of things. I'm just going to throw them out there in no particular order. Number 1, it sounds like you completed the PDN sales force build, and I'm just curious how that is going. Number 2, when you talk about historical CAGRs, what historical CAGRs?

And then last but not least, if you can give us an update on the CEO search. Thank you.

Speaker 2

Okay. Thanks, Joanne. Why don't I take the PDN sales force build on the search and I'll let Rod take to the CAGR question. So the PDN referral sales force build is sort of an ongoing process. We tend to go in tranches once or a couple of times a year in the past.

So I think this year it will be more of a continual building. So we've come into this year with a referral sales team of a little more than 50 individuals, I think, will probably exit this year with something closer to 80 to 90. And that'll be kind of a gradual building in probably a couple of different chunks. That Effort, I think, continues to not only go well, but get better and better over time as we learn the backgrounds of those who have been successful, where to put them, how to pair them with our existing SCS sales force, messaging, targeting, etcetera. So I think that the point on that particular Spear has gotten sharper and sharper.

In terms of the CEO search, Joanne, really there's not much To add, we obviously just made that announcement pretty recently. I can tell you that we are heavily in the midst of that process. There's a lot of activity. I'm very encouraged by where we are and where I think we'll end up. And when we know more, You will know more, but we continue to be on a path to conclude this, obviously, in calendar year 'twenty three, which was our direction.

You want to take the CAGR question? Sure.

Speaker 3

And Joanne, I think you're referencing the historical sales CAGRs and market CAGRs. In the past, what we've talked about is prior to the pandemic, the market Consistently grew in that mid to high single digit compounded annual growth rate on a year over year basis. And we've continued to assert that we believe that there's no reason why the core market Can't return to those sorts of levels in the near future.

Speaker 1

Thank you.

Speaker 0

Your next question is from the line of Chris Pasquale with Nephron. Your line is open.

Speaker 4

Thanks. A couple of questions. 1 on IQ. Just curious whether you have any plans to quantify the clinical benefits of that platform in some sort of trial setting. And then Keith, you mentioned that you thought that PDN could eventually become a third of the U.

S. SCS market. I guess, why that number? I mean, the opportunity here would seem to be potentially even larger in terms of the number of patients than the core opportunity. So why set that ceiling at a third?

Speaker 5

Okay.

Speaker 2

Let me take both of those. From an IQ standpoint, Keep in mind that what the IQ is doing is automating the patient's journey and progression along an algorithm that's already established. So if you look at all of the clinical data out there in the literature on the performance of high frequency SCS therapy, pain relief metrics and many other things that all applies to IQ. And the whole idea is to make that journey for the patient because it is something that takes a little bit of time once they go on the therapy is to make that journey quicker, more predictable, and more in the control of the patient. So We've been generating data now for well over a decade and it all supports IQ.

Now having said that, we are going to continue to gather data specifically on the IQ capabilities and its ability to do what we've said it can do, which is get the patient to Relieve with more engagement quicker and to keep them there. So we'll continue to gather data, both real world data and you'll probably see some more prospective clinical trial activity out of us as well. So stay tuned. In terms of PDM, we're not Applying a cap to that market, Chris, I don't think we said anything even close to that. I think what we're trying to do is give you a sense of as we Look out over the next 3 to 5 years when we think about how does the core SES market grow over that time frame and what do we think is sort of in the center of the possible.

We place it around that area. Look, it's a very large market with patients who are in a great deal of need without any other really good option. So Could it be 50% of the SCS market? Could it double the SCS market? Of course, those outcomes are possible.

The TAM would justify all of them and then some. We're just trying to communicate to you what we think is maybe kind of the center case of our various scenarios. It's not a cap.

Speaker 5

Thank you. That makes sense.

Speaker 0

Your next question is from the line of Larry Vigilsen with Wells Fargo. Your line is open.

Speaker 6

Hey, good afternoon. This is Vik Chopra in for Larry. A couple of questions from us. So you expect Q1 sales to be down about 17% sequentially, which is a steeper decline than what we saw in 2022, which has the Omicron effect. It's also your easiest comp.

Just trying to figure out if this is conservatism or if that's something you're seeing in the market that leads to a greater than That did sequential decline in 2023. And then I had a follow-up. Thanks.

Speaker 3

Hey, Nick. Yes. It's definitely within the line of what we've seen historically in other years. So there isn't anything particular to point out. It's kind of the way Yes, as we look at our trialing and perm activity over the months leading up to it and it leads us to that kind of $94,000,000 to $96,000,000 range that we spoke about.

There's really not a whole lot more than that to speak about and then we do start to see sequential growth throughout

Speaker 4

for the rest of

Speaker 3

the year to get you to that annual guidance.

Speaker 2

Yes. The only thing I would add to that, Vic, is that we if you look at the Comparable period that you're talking about, the pandemic had an impact in the 4th quarter as well. In the last half or 2 thirds of the month of December, it had a pretty dramatic impact. So it's not at least in our business. So it's not quite as simple as saying, hey, we had a pandemic impact with Omicron in Q1.

So why the difference?

Speaker 6

Got it. It's helpful. And then my follow-up is you've talked about pricing pressure in Q4. Just curious what you're seeing now and what you're assuming for 2023? Thanks for taking the questions.

Speaker 3

Yes. So we remember, we're in limited launch of IQ and we're on the tail end Of Omnia. And so, yes, we've continued to see some pricing pressure in Q4. As we go throughout the year, we haven't provided any guidance so far on pricing on IQ. We have spoken generally about how with a new product release, we do anticipate that we should be able to get a little bit of a bump in price, but it's a little bit of a complex equation as We roll throughout the year in terms of the mix shifting to IQ and away from Omnia.

So We're anticipating overall that pricing roughly kind of holds for the year. But beyond that, we're not providing a lot of specifics on the IQ pricing.

Speaker 0

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

Speaker 7

open. Hi, everyone. Thanks for taking the question. Just one quickly on kind of the clinical data that you guys have read out. Recently, you have 2 year positive data sets for PDM and NSR DP, both strong data and randomized controlled trials.

So I'd assume maybe you guys will start to engage with payers, either if you haven't already, you will in the near future, especially in the NSR VP side to try and firm up some of those coverage decisions. So just curious status on that end and if there's any expectations for updates in the next year. Thanks.

Speaker 2

Well, you're right. The 2 year data is important and it's to some payers very important in terms of follow-up. Now a lot of times 2 year data in the minds of a payer means a 2 year publication. So while the data now are in and they've been presented, They will be submitted here shortly for peer review and publication in a journal. That doesn't mean we wait for that to communicate with With payers, I think as soon as that data become that data set becomes available, we have them in front of payers, and we're engaging those By the way, on an almost constant basis, our communications with payers aren't really episodic.

They're just ongoing. And we have a strategy for each payer and its multiple communication points throughout the year. So we're talking to payers now that the 2 year data sets are have been presented. We have to be a little bit careful. We don't want to jeopardize publication.

So we don't to spend too much time on the details our investigators presented to their peers. So the publication will make it a lot easier for us to do that from a couple Sandpoint and that will come a little bit later this year hopefully sort of in the middle part of the year.

Speaker 0

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

Speaker 8

Yes. Hi. Thanks for taking the questions. I want to start, the guide feels very similar to the guide for 2022 with a depressed 1st half and a much better second half with mid teens growth. That didn't end up playing out last year despite a pretty good MedTech Environment.

So what gives you confidence that the market can accelerate to those mid teens levels in the back part of the year?

Speaker 2

Yes. I mean, look, every year is different. And we base the guidance that we give during the beginning of the year based on the available data to us at the time. So what happens in 1 year has little read, I think, on what's likely to happen the next. As we look at guidance for this year, Robbie, we're looking at exit velocities of procedures, we're looking at claims data, reported sales.

We're looking at a bunch of our own market research with both patients and doctors. And we're making some what we think are probably pretty conservative core market assumptions. And assuming that things like IQ and NSPP data give us the ability to grab a little bit of share in the core back and leg market, although even those assumptions are not what I would call too aggressive. And then a lot of the growth assumption is based on what we think the trajectory of PDM looks like. We have a lot more data on PDM obviously coming into this year that we did last year.

It's guidance. It could be wrong on either direction. But I feel like we're We've got a little bit more illumination this year on what's happening in the market than we did last. And it is our best estimate of where where we think this year is headed.

Speaker 8

Great. I appreciate it, Keith. And maybe just one follow-up along those lines. The PDN sales for Q1 came in a bit below where the Street was thinking. I think In general, we weren't expecting that much seasonality during the launch here.

So maybe talk to what you're seeing, why PDN seasonality in line with the base business is the right way to start the year and expected. And also As it ramps, it kind of ends in the low to mid-20s, I would imagine, 1,000,000 to get to the guidance range. How are you thinking about competition in PDN, if at all. Thanks a lot.

Speaker 2

Yes. No, I think the seasonality question is a good one. We actually did some work on that ourselves, Went back and looked at our initial ramp as a company. We looked at some of the initial ramps of other to earlier stage high growth neuromodulation companies. Seasonality shows up pretty early and seasonality is in general a pretty strong factor in this sector and maybe a little more so than other med tech sectors that I've been around.

And I think generally what we've seen is seasonality shows up pretty quickly. Once you get past sales growth rates that are not, say, a multiple of prior year, but something sub-one 100 percent Growth rate seasonality, at least in the Q4 to Q1 cycle shows up pretty early. It did for us and it has for other companies. So I don't think we're terribly surprised. I don't think we think it has much bearing on our guidance for the balance of the year.

I think PDI is one of those areas of our guidance where we have actually a fairly high degree of maybe relatively higher degree of confidence. In terms of competitive approvals, Medtronic has been approved for a while. We've had a pretty good long chance here to see what They've done in the market and how they've changed share or market growth. I think we've talked about this a little bit in the past. We do see them out there.

And we're hopeful over time they'll have maybe a bit more impact on the growth of the overall market. But to date, it hasn't been a big impact and certainly hasn't been a big impact in terms of share. Abbott, of course, is now approved. We talked about this before as well. We knew this was coming, especially since Medtronic got their approval based in part on Abbott data.

And I think Abbott has made it clear that they submitted virtually the same Medtronic and Abbott data that Medtronic submitted. So we expected this to come. The data that Abbott has out there, it isn't new. It's the same data set Medtronic put forward. It's 2014 trials that were never used for a submission before that never moved the needle with payers or patient referrals before, and we don't really expect them to have A big impact now.

Now, we hope that Abbott has some impact on awareness of the therapy, awareness among societies, referring doctors, etcetera. But we don't know yet. That's a very new approval. It remains to be seen how much they invest in that, what they do with it and what kind of impact they have. I think we probably expect it to be at least this year relatively minimal.

Speaker 8

Great. I appreciate the thoughts.

Speaker 7

You bet.

Speaker 0

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

Speaker 5

Hey, this is Dave Brascott on for Rich. Thanks for taking the questions. Rod, I wanted to follow-up first on a comment you made related to Joanne's a question about returning to these historical mid single digit to high single digit growth rates. Wondering if that comment that market growth is inclusive of PDN or if that's specifically relevant just to the core SDS market in the U. S.

And I guess based on that answer, If guidance for 2023 does assume that there is a return to that historical CAGR and if so, when?

Speaker 3

Yes. Thanks. So when we've talked about the CAGR in the market, we've generally spoken about it from a core back and leg perspective. So we do believe that this market has the potential to return to those sorts of historical year over year growth levels that we saw in the 20 10 to 20 18, 20 10 to 20 19 sort of the period. So we are talking excluding PDN in that case.

As far as this year, we're still assuming pretty modest core back and leg market growth on the year with a slower first half and a little bit of a stronger growth period in the second half of the year from a market perspective. So Overall, we're anticipating kind of low single digits for the market on the year.

Speaker 5

Okay. That's helpful. And then I guess on the based on kind of the full year and 2020 Q1 adjusted EBITDA guidance, Yes, there does appear to be a pretty steep acceleration curve implied between Q2 and Q4. So I'm just wondering if we should be thinking about that improvement It's more gradual, more back end loaded. And then if at all that more profitable growth you're getting out of HFXIQ, Is that product contributing to any of the improvements in the EBITDA profile in 2023?

Thanks.

Speaker 3

Yes. So when you're talking about that acceleration, are you primarily talking revenue or are you

Speaker 5

talking adjusted EBITDA? Just adjusted EBITDA.

Speaker 3

Okay. Yes. So we as we mentioned, Q1 historically carries a disproportionate amount of operating expenses. We also mentioned that the 1st 3 quarters of the year that we're going to have some headwinds from a margin perspective with Costa Rica as we're bringing that manufacturing plant up to scale. We'll start to see some of the expansion and that's related to IQ as well as Costa Rica getting to sufficient scale in the 4th course, we'll see some of that expansion or I think what you called acceleration in the Q4 as a result of that margin expansion, but also with a disproportionate amount of operating That is in Q1 and then, less so in the next three quarters.

It's driving that adjusted EBITDA expansion you're talking about.

Speaker 5

Okay, thanks. And just is there any contribution to that margin from the HFXIQ launch. I know you discussed that it can drive more profitable growth. Just wondering if there's any contemplation about that in 2023

Speaker 3

Yes. So we'll see some expansion from IQ. So there's a couple of factors there. One is, it will start to be a significant portion of our product mix later in the year, and we do anticipate that we'll receive some pricing increase as it relates to IQ. We're also manufacturing that product out of Costa Rica.

So when we get into Q4, we'll start to see some favorability from IQ being out in the field, both from a price and a cost perspective, and that's driving some of that margin expansion.

Speaker 2

Well, I would add one more, maybe one more element to that, and that's the operating expense dimension of IQ. I think when you There's a disproportionate amount of support given to patients in their 1st 3 to 12 months of support on our technology. And so I think when we get to the point where a substantial percentage of all of our new patients are going on to IQ that the promise of less intensive support needed for those patients should start to contribute to our ability to scale a little bit differently. And I think so I think where that part of the cost story starts to show up is probably in 2024, mostly in 2024 where the incremental growth driven by the IQ should be should require a little bit less Field support and make our field team more efficient in driving that growth.

Speaker 5

Okay. That's helpful. Thanks.

Speaker 0

Your next question comes from the line of Adam Maeder with Piper Sandler. Your line is open.

Speaker 9

Hi, Keith. Hi, Rod. This is Simran on for Adam. Thank you for taking the questions. Just Two quick ones from me.

So the first one, on NSRBP, have you Seeing any progress with the payer community. I think you presented the 2 year follow-up data at NAND last month. So I'm just kind of curious how this opportunity is trending both from a reimbursement and patient awareness standpoint. And maybe just specifically, have you seen any impact in the marketplace from the United no coverage policy that went into effect. I think it was announced at the end of last year.

So just if you've seen any impact there. And then just my second question is on the topic of Competition in the core SCS market. There is a new entrant coming to the market this year with a closed loop system. So any thoughts on potential impact there and any new dynamics worth highlighting. Thank you.

Speaker 2

Okay. That's a ton. So let me try and be efficient here. In terms of impact on the payers, yes, we've begun, we think to get to traction with payers and with patients on an individual basis getting them approved in the NSVP We have been pretty consistent from the very beginning saying this would play out over time and it would require ongoing follow-up from this study and other studies and it would require our competitors jumping in in driving this as well. And we continue to believe that, but we have begun to see some impact.

I think having the 24 months data out there and ultimately Publish will give us a bit more leverage in our payer conversations. But I think this is something that will be a gradual tailwind to the core back and leg market over the next 2, 3, 5 years as we see more data, more patients and more pressure to treat these patients who don't have an option. On the UnitedHealthcare decision, we did speak to that in the script a few moments ago. We haven't seen an impact from that to date, and we don't expect to see a material impact this year, which is I think is what we said a few months ago and we reiterated that today. And finally, on the new competitive entry to the market.

I think you're referring to Saluda. And they are FDA approved as We understand it for a product they don't intend to broadly launch and they are waiting for FDA approval for a version of their product that they do hope And intend to broadly launch. And so they're really in a very small limited market release in the U. S, so we're not seeing much of an impact. We're hearing different things.

You should ask them, of course, but we're hearing different things. Most frequently, we're hearing sometime later this year for an approval and a market launch. I refer you back to 1 or maybe 2 quarters ago in our transcript and Julie, I'm sure can get it to you. We spoke at great length to the comparison of what we're doing with the IQ product to low frequency eCAPS closed loop. They're entirely different things.

We think we're really well positioned. And I won't go through all that again today because we really spent quite a lot of time on it. And I don't think the fundamental comparison has much changed since then. So anybody who would like to be referred to the proper part of the transcript and the right quarter, just contact Julie Dewey and she'll get that to you. But I think we feel like we're very well positioned.

I think this may be a bit of a pitch battle between low frequency competitors that do or don't have ECAPS closed loop. I certainly think we have customers that will want to try anything that's new, but the idea of going back to paresthesia, which everyone's been trying to get away from, back to mapping patients in the OR, waking them up to do so in the face of everything we have to offer with high frequency and now AI driven It seems unlikely to us that it will happen in large numbers. So I like our position actually. I like the way we're set up in the market with our current offering.

Speaker 0

Your next question is from William Plovanec with Canaccord Genuity. Your line is open. Hi, it's John on

Speaker 4

for Bill tonight. Thanks for taking our questions. To go back on the NSBP insurer coverage, Keith, you announced the PDN trial today, which you said could help with reimbursement. Do you think the company is to sponsor another clinical trial in NSBP to also help with those non coverage policies? Thanks.

Speaker 2

Sure. I think it could. I think in this case, we assume that our competitors as they already We'll begin publishing some data on NSVP as well and we think that that will help with payers. I think the payers will tend to look at data as an industry and not make company by company distinctions in this area. So I think further trials will help.

I think they always help. And I think that's what we'll see, both frankly from Nevro and from our competitors. NSBP is a little bit different with payers are well aware that these PDN patients have No other options that they pose a unique and difficult problem for not only the patient, but for the payers themselves. And I think they've been very receptive to what we've given them, which has been very high quality evidence of a new solution. I think

Speaker 3

in the case of NSVP,

Speaker 2

payers are probably over the years in the habit of thinking of SCS being kind of end of care pathway option. And we are asking them to flex a little different here to think about patients who don't have a surgical option, and therefore SCS gets moved up a little bit in front of an That doesn't exist, but they're just not used to thinking of it, of the care algorithm that way. So I think we've always viewed NSVP is being a little bit tougher conversation with payers as they get used to a different care pathway for a certain category of patients who aren't surgical candidates. And I think that's exactly what we're seeing. But I think the conversations we've had with payers have been productive.

I think they've been completely rational. I think high quality evidence usually ends up carrying the day and we believe we will hear as well.

Speaker 3

Thanks, Keith. Yes.

Speaker 0

There are no further questions at this time. I will now turn the call back over to Mr. Keith Grossman for closing remarks.

Speaker 5

All right.

Speaker 2

Thank you everyone for joining us, for taking the time today. I'm sure some of you will have questions after this call and and we'll look forward to taking them. Otherwise, we'll talk to you next quarter.

Speaker 0

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