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spk14: Good afternoon. My name is Lisa, and I will be your conference operator today. At this time, I would like to welcome everyone to Nevro's first quarter 2023 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star 1 on the telephone keypad. If you would like to withdraw your question, you may press star 1 again. I would now like to turn the call over to Julie Dewey for introductory remarks. Please go ahead.
spk03: Thank you, and good afternoon and welcome to Nevro's first quarter 2023 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, Executive Chairman, Kevin Thornall, CEO and President, and Rod McLeod, Chief Financial Officer. On our call today, Keith will introduce Kevin, and Kevin will make some brief comments, and then Keith will discuss our first quarter business results. Rod will conclude with our detailed financials and guidance, and then we'll open up the call for questions. Please note there are also slides available related to our first quarter performance on the NEVRO Investor Relations website on the events and presentations page. Earlier today, NEVRO released its financial results for the first quarter ended March 31, 2023. 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 April 26, 2023, 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 reports, on Form 10-K, filed on February 21st, 2023, for a detailed presentation of risks. The forward-looking statements in this call speak only as of today, and we undertake no obligation to update or revise any of these statements. In addition, we'll refer to adjusted EBITDA, which is a non-GAAP measure that is used to help investors understand NEBRO's ongoing business performance. Non-GAAP-adjusted EBITDOCS includes interest, taxes, and non-cash items such as stock-based compensation and depreciation and amortization, as well as litigation-related expenses, certain litigation charges and credits, and other adjustments such as restructuring charges. 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.
spk12: Thank you, Julie, and good afternoon, everyone. We appreciate your joining us. Before I jump into our Q1 results, I first want to introduce Kevin and just say how pleased the board and I are that our search resulted in his appointment as CEO. Throughout his career, Kevin's established an excellent track record of leading medical device businesses that deliver strong growth and commercial excellence. He's an ideal fit in every way for where Nevro is today and where I believe it can go in the future. And we just couldn't be more pleased that he joined the team. So I'll turn the call over to Kevin so you can hear directly from him. And since he's been on the ground here for just a little more than 48 hours, I'll come back in a few minutes to review our progress over the last quarter, and then we'll all field your questions at the end of the call. Kevin?
spk07: Thanks, Keith, and good afternoon, everyone. I'm pleased to be speaking with you today on my very first quarterly conference call as Nevro's CEO with just two days underneath my belt. Let me begin by saying how delighted I am to be joining Nevro at this time. I took on this opportunity because I have great respect for Nevro's history of delivering differentiated, protected, best-in-class solutions that are backed by strong clinical evidence that make a difference in patients' lives. Nevro has truly disrupted the SCS market. not only with its high-frequency 10 kilohertz technology, which revolutionized SCS treatment, but also through its decisions to pursue rigorous, randomized clinical trials to lead the way in developing new indications like PDN and NSBP, as well as amassing an HFX cloud database that now powers our new AI-enabled HFX IQ system. I was also impressed by the company's vibrant culture and with the team members I've had the opportunity to meet so far. We're lucky to have such a smart and dedicated team of people who are passionate about our company's mission. In our case, to deliver comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. My top priorities will be to build on significant progress the company has made to power growth and to take advantage of the meaningful leverage opportunities we have to drive towards profitability and deliver shareholder value. Over the next several months, I'll be spending time with our leadership team, employees, commercial organization, customers, and key stakeholders to fully understand the business. In addition, you should know that I, along with the rest of the leadership team, will be focused on where we take Nevro from here to continue to win in the SES market and fully capitalize on the opportunities ahead of us. One thing that won't change is supporting our customers and patients in ways that continue to set the standard in our industry, which I believe will enhance Nevro's growth trajectory and further differentiate our leadership position. I look forward to sharing more in the future earnings calls. Finally, since this is my first earnings call as Nevro's new CEO, it also means that this is Keith's last earnings call. I really appreciate all Keith has and will be doing in these early days of my tenure to ensure this transition is a smooth one. And I look forward to continuing to work with him in his executive chairman role. I'll now turn the call back over to Keith to review our first quarter results.
spk12: Thanks, Kevin. Let me say it's just been a real privilege to lead this company over the past four years. and extremely rewarding to work alongside the talented and dedicated people who are committed to Nevro's vision, mission, and values. And I also want to thank the customers and clinical advisors who have treated over 100,000 patients globally with HFX therapy for their confidence and belief in our clinical evidence. As we move into the next exciting chapter in the Nevro story, I have full confidence in Kevin and the entire Nevro team, and I look forward to supporting them in my new role. Okay. Let's turn over to first quarter results and updates on the business. We continue to move the business forward in the quarter. Our revenue and adjusted EBITDA results both exceeded our guidance range, and U.S. procedure growth rates grew in the double digits. I'm really pleased with the building blocks that are now in place for attractive growth and leverage going forward, and it's now becoming clear that the challenges to our market are improving, and we believe they will continue to improve throughout this year and beyond. There were lots of encouraging elements of our progress in the first quarter. Global revenue growth was 11% over prior year on a constant currency basis, while U.S. revenue growth came in at 12%, and U.S. trial activity delivered 9% year-over-year growth. PDN continues to be a significant growth driver, of course, with strong first-quarter growth of 160% over prior year. In March, we began the full market launch of our HFX IQ system in the U.S., Since the launch, we've received positive feedback from physicians and patients regarding the ability to deliver personalized pain relief using our big data-backed HFX algorithm. Now, more on IQ later in my remarks, but I'm really convinced this technology 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. We continue to see encouraging growth in trials and permanent implants, and we continue to believe that the underlying fundamentals of the addressable SES market and the opportunity for growth remain largely intact. I think, by the way, that the recovery that is underway is unlikely to be linear in nature, as we've discussed before. As of today, three of the four main market participants have disclosed their Q1 SES results, and in that context, we're very pleased with our growth, particularly in the U.S. market, where it's pretty clear that we continue to capture share. I'm equally encouraged by the fact that the SCS business for these other participants grew in the high single digits, which bodes well for total market recovery, as this is the second quarter in a row that it has continued to move in a positive direction. In Q1, we completed another round of physician market research. Nearly all physicians surveyed said they're satisfied with SCS therapy, and approximately 80% of physicians said they want to increase their SCS volume in 2023. Additionally, roughly 60% said they expect their SCS volume to grow this year compared to prior year. Not surprisingly, a majority of physicians also said they continue to experience lingering issues such as staffing challenges and ongoing payer pressure in the pain space, but that the actual impact that staffing challenges are having on volumes appears to be declining. Remember, SCS is considered a late or even last line therapy used to relieve patients of their chronic pain when surgeries and more conservative treatment options either don't provide optimal relief or just simply are not an option. We know from previous research that the pandemic and some of the lingering issues from the pandemic had slowed the pace at which patients moved through that treatment pathway. But we've seen positive indicators of growth and recovery, including patients entering the pain treatment funnel. Physicians told us that their back and leg pain patient visits had improved in 2022, with approximately 87% of physicians stating volumes were equal to or greater than patient visit volumes in 2019, the last pre-pandemic year. They also indicated this trend is continuing, with just over 80% stating their Q1 patient visit volumes had grown or stayed the same compared to prior quarter in Q4 of 22. We believe this level of patients returning to our customers' practices ultimately bodes well for continued recovery of the SCS market. As patients make appointments with their pain specialists and continue to move through the treatment pathway, we're confident we'll see more patients who are ready for SCS in the market return to historical growth rates. Now, turning to our PDN business. PDN trials represented approximately 19% of our total U.S. trial volume, and that percentage actually improved throughout the course of the quarter. That's up from 11% of our total US trial volume in Q1 of last year. Among our permanent implant procedures, PDN represented 16% of the total worldwide procedures, resulting in approximately 15.6 million in PDN indication sales. And that's an increase of 160% compared to 6 million in the first quarter of last year. We attribute this in large measure to the PDN referral sales organization expansion that was completed last June. our direct outreach initiatives to physicians and patients, and the general enthusiasm regarding the compelling data and real-world outcomes in these otherwise difficult to treat patients. Our current plan is to continue to increase our PDN referral sales team footprint to about 90 or so by the end of this year. That's up from around 50 at the end of 2022. We continue to see successes with our direct to patient marketing for PDN as well. In Q1, approximately 18% of our US PDN trial procedures came from leads generated by our DTC programs. And in the month of March, a record number of PDN trials came from these DTC leads. In addition to the existing payer coverage policies that are 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 prior off denials, including with payers who don't have a positive PDN coverage policy in place. For those PDN cases that have come through our own access group, our rolling 12-month approval rate at the end of Q1 continued to trend around 75%, and that was up from about 62% at the end of 21. In the case of prior off denials, we're able to leverage our published clinical data, our FDA-approved PDN indication, and inclusion in various society guidelines, making strong evidence-based arguments for patient approval, resulting in success in over half of denial appeals we submit through our patient access group. Earlier this week, Dr. Erica Peterson presented the complete 24-month PDN RCT data at the American Academy of Neurology Conference in Boston. These results confirm the long-term durability of pain relief as well as clinically meaningful improvement in neurological function and quality of life achieved with 10K LRCH therapy. We were honored that our 24-month PDN data was selected for a Merit of Distinction by the AAN and congratulate Dr. Peterson and all of the SensiPDN investigators who participated in this landmark trial. Distinction is awarded to the top-rated abstract in each topic category. based on the quality of study and interest to the neurologic community. We expect to submit the complete 24-month PDN RCT data this quarter for publication. In addition, we enrolled our first patient this quarter in our new PDN sensory study, which is the first prospective RCT specifically powered to assess restoration of neurological function as a primary endpoint in patients with intractable PDN. Diabetes and peripheral neuropathy pose a staggering socioeconomic burden, and there is no available disease-modifying treatment option available for patients with PDM. By restoring sensation in the feet, 10 kilohertz SCS therapy 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 healthcare costs. You'll recall that the observed neurological improvements we saw in the original sense of PDM study are unique to 10 kilohertz SES therapy, have not been reported for any other competitive low frequency SES therapy. Now, before I leave PDM, let me add that it has made sense for us to break out PDM in the critical first stages of the commercial launch. Moving forward, Kevin and the team will be further evaluating if this reporting approach continues to make sense. After all, we now have two other PDN on-label competitors who do not segment their SCS business at all. And I'm not sure disparate levels of disclosure here serve us well competitively. Remember that each of our competitors have different unreported segments in their business, whether it's leg versus back pain or even upper limb and neck pain, primary cell replacement volumes, PDN volumes, NSVP, even some PNS or peripheral nerve stem utilization, DRG implants, etc., all of which are not broken out and are simply reported as part of their SES share. And the truth is, all of these SES indications use the same technology, are sold and serviced by the same organization, and are deployed by the same implanting physicians to treat chronic pain. We're interested in driving overall market share gains and company growth, period, and we're doing just that. Moving now to non-surgical back pain, we've submitted the two-year data from our NSBP trial for publication. This data included clinically important and stable pain relief in patients treated with 10 kilohertz SCS as well as strong durable improvement in reported function and 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. We expect to see these data published in the second half of this year. Once published, this will enable us to more fulsomely engage with commercial carriers about the benefits of HFX therapy for NSPP. On the new indication coverage front, our PDN coverage continues to grow. Two additional Blue Cross Blue Shield commercial carriers added coverage in the first quarter, bringing us to nearly 60% of PDN patients with health plans offering coverage for PDN. Assuming Novitas and First Coast, the last two Medicare administrative contractors, with pending local coverage determinations, finalize their proposed coverage, total coverage will increase to just over 70% of PDN-covered lives. With regard to NSBP, to date we have not experienced any noticeable impact on our revenue from any health plans not specifying coverage for NSBP patients. The approval rates on a case-by-case basis for NSBP remain consistent with other indications such as PDN and traditional back and leg pain. in failed back surgery patients. Now, I'd like to turn to our new CEMSA HFX IQ system. In March, we initiated the full market release of IQ in the U.S., and it's been really well received. IQ is the first 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. This combination of really big, real-world clinical data, AI, and direct patient engagement and input is intended to optimize and maintain pain relief on an individualized basis, engaging patients in their therapy, and giving patients more control over their 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 that IQ will lessen the burden on our patients and our customers and expect this launch to support our growth prospects in 23 and well beyond. As we've pointed out before, the IQ product line is also a logical step in allowing us to drive a more attractive cost of growth as it enables our existing team to scale over a larger base of patients and revenue going forward. I think that this combined with the ramp up of our Costa Rica manufacturing facility is really going to help us with earnings productivity on our revenue growth in the coming years. Although still early days in the full launch, anecdotal feedback on IQ from current customers as well as physicians who use competitive devices has been quite positive. During our earlier limited market release, 95% of physicians surveyed indicated they are satisfied using the IQ system in treating their chronic pain patients And 95% of patients found answering the daily questions through the HFX app very easy to do. 98% of patients also agreed to achieve personalized pain relief. Their input was required. Not only does IQ give our sales team the opportunity to discuss an exciting new product with their customers, but it's also changing the narrative around how SCS therapy can be delivered, optimized, and maintained using our AI-enabled treatment algorithm to provide relief to patients. One physician recently summed up IQ by saying that he felt it harnessed the power of all the programming experience and clinical outcomes from tens of thousands of patients and put all that into the palm of a patient's hand. As with any new digital product launch, we'll continue to optimize functionality and add new features over time that improve the patient experience with the app. In Q1, HFX IQ already accounted for about 11% of our permanent implant procedures. And with the full launch of HFX IQ underway, we expect a meaningful shift in mix to the IQ product throughout the rest of the year. In summary, the IQ reflects our continued commitment to deliver comprehensive, life-changing solutions for patients with chronic pain. And it keeps Neuro firmly at the forefront of innovation as we continue to bring new technology, new data, and new indications to our customers, and to our patients. So, in closing, we made what I think is very encouraging progress in the first quarter. With what we believe will be continued recovery in our markets, important new products like the HFX IQ platform, entirely new patient populations such as PDM and MSVP, 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 our best days are ahead of us. And I wish Kevin and the entire Nevro team all the best going forward. And with that, I'll pass the call over to Rod to provide further details on our first quarter results and our guidance.
spk13: Thanks, Kevin and Keith, and good afternoon, everyone. I'll begin with our worldwide revenue for the first quarter of 2023, which increased 10% as reported, and 11% on a constant currency basis compared to the first quarter of 2022. PDN represented 16% of worldwide permanent implant procedures, which resulted in approximately 15.6 million in PDN indication sales in the first quarter of 2023. And just as a reminder, this quarter includes the same number of selling days as Q1 of 2022. U.S. revenue in the first quarter of 2023 increased 12% compared to the first quarter of 2022. International revenue in the first quarter of 2023 decreased 4%, as reported, and 1% on a constant currency basis. Now let's move to some details below the top line. Gross margin was 67.1% in the first quarter of 2023 compared to 67.3% in the first quarter of 2022. The full market release of the HFXIQ system continues to progress well, and the company anticipates a meaningful shift in mix to the HFXIQ product throughout 2023, which combined with the ramp up of our Costa Rica facility is expected to benefit gross margin beginning in the fourth quarter of this year. Looking at operating expenses year-over-year, the increase was primarily related to personnel-related costs and travel, conference, and meeting expenses. As we've seen historically, Q1 always experiences a disproportionate amount of annual expenses due to the NANS conference, our global sales meeting, as well as certain other Q1 heavy expenses such as payroll taxes and 401 matching that reset in the new calendar year. This year's Q1 expenses are 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, which does not have a Q1 comparable from prior year, and a robust NANs presence, which was more subdued in 2022. Non-GAAP adjusted EBITDA for the first quarter of 2023 was a loss of $17.1 million. compared to a loss of $14.1 million in the first quarter of 2022. Cash, cash equivalents, and short-term investments total $341.8 million as of March 31, 2023. This represents a decrease during the first quarter of 2023 of $32.6 million. As a reminder, the first quarter of each year is always a high cash outflow quarter, primarily due to annual incentive compensation payouts, 401 matching, and other beginning of year payments that are amortized the remainder of the year, such as insurance. Excluding these items, uses of cash were in line with normal business operations, as well as our projections. We continue to manage our working capital and are very comfortable with our balance sheet to fund operations. Now let's turn to guidance. It's important to note that we will be using non-GAAP financial measures to describe our outlook for the business. Please see the financial tables in our press release issued today for gap to non-gap reconciliations. Keep in mind that the guidance we are providing today assumes the full year of 2023 will continue to see steady improvement in provider capacity impacted by 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. We expect second quarter worldwide revenue of approximately $110 million to $112 million, which represents 6% to 8% growth on a constant currency basis. PDN indication sales are expected to grow sequentially in Q2 and each quarter for the remainder of 2023, given the strong underlying momentum in this indication. We expect second quarter of 2023 non-gap adjusted EBITDA, to be a loss of approximately $4 million to $5 million. We continue to expect worldwide revenue for full year 2023 of approximately $445 million to $455 million, an increase of 10% to 12% over prior year on both an as reported and constant currency basis. This full year 2023 guidance includes approximately $75 million to $85 million of PDN indication sales an increase of 56 to 77% over prior year. We continue to expect full year 2023 non-GAAP adjusted EBITDA to be in the range of negative $5 million to negative $10 million, which compares to a non-GAAP adjusted EBITDA loss of $23.8 million in 2022. In closing, we made good progress in the first quarter and remain on track to drive growth and scale profitably in our core business in the years ahead. We're in a great position strategically with best-in-class SDS technologies, remaining share gain opportunity, future growth opportunities in PDN, NSVP, 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.
spk03: Thanks, Rod. In order to get through the question queue efficiently and take as many questions as we can, please limit yourself to one question and a brief related follow-up. You can then rejoin the queue, and if time allows, we'll take additional questions. Lisa, we're ready for the Q&A instructions.
spk14: Thank you. At this time, I would like to remind everyone, in order to ask a question, you can press star then the number one on your telephone keypad. We'll pause for a moment to compile the Q&A roster. Your first question comes from the line of Larry Bigelson with Wells Fargo.
spk11: Good afternoon. Thanks for taking the question. And Keith, congratulations on your retirement. I wish you well. And Kevin, welcome. Let me start, Kevin, with a question for you. Can you hear me okay? Yep, we can. Oh, great. So, Kevin, can you talk about your priorities in the first year? and or this year and then you know never reiterated the guidance um in your uh announcement and today so how did you get comfortable you know with the guidance in such a short period of time you know we usually see new ceos lowering the bar uh to set themselves up for success you know how can we be confident you won't do that thanks
spk07: Yeah, thanks, Larry. Appreciate it. So number one is sort of the priorities here. You know, my first priority is really to learn from this amazing team. Obviously, there's people who've been here for a long time that have had a lot of success, both on the clinical side, commercial side, you know, all around. And I'm going to spend the first few weeks not only here in Redwood City to meet everyone, but also out in the field and with our customers here really soon and the KOLs here as well. I do have some experience in this space with the prior organization, and I know a lot of these KOLs, and I know a lot of the reps are actually out in the field for us here at Nevro. And so I look forward to learning from those closest to the customer, which typically is where you have the best insights and learnings from. As far as the guidance, I actually got comfortable with it because if you look at all the things that Rod just mentioned that we have going for us, obviously with the new product launches, all backed by superior clinical evidence, and with the opportunities to grow into new indications, the PDN momentum and obviously the HFX IQ launch, that's a lot of good opportunities that we have to execute on. And then also, when you really think about the factors that account in setting our guidance range along with other factors, competitive introductions and now hearing from three of the four competitors in the space, that's what gets us comfortable with our guidance.
spk11: All right. Thanks so much. I'll leave it there. Good luck in the new role, Kevin.
spk07: Thanks, Larry.
spk14: Your next question comes from the line of Bill Plodognik with Canaccord.
spk10: Great. Thanks for taking my question. And I echo Larry's comments for both Keith and Kevin. Just, you know, my question is really going to be more on market share. You know, as we look at this, you know, Keith and Rod, just on the numbers, you know, it looks like the U.S. spinal cord business was flat, which is a great improvement when you strip out the PDN But I'm just curious when you can, you know, your commentary that you think you're taking share when the other players are reporting pretty solid numbers, you know, that would imply that they're seeing flat in SCS too. And I don't think the commentary said that. So I just kind of want to maybe get a little better understanding. Like I said, you know, we're seeing the U.S. leg and back SCS grow, or at least starting to flatline, which is a huge improvement. But It kind of doesn't match up to the share shift you kind of discussed, so that's my question.
spk12: Yeah, so we track this very carefully in a very detailed fashion. Now, some of this information obviously just came out as recently as even this morning. But I think a fundamental difference is, I think, based on what you've said and the way you phrased your question, is you're carving out PDN. And we just don't do that. Look, we have a higher back pain percentage than our competitors who have a higher leg pain percentage. We don't track them differently. We've all always treated some portion of non-surgical back pain, but at different levels. We don't track that. We're used at disparate levels for upper limb and neck pain. That's not something we break out and track. At least one of our competitors gets used, at least with some frequency, for peripheral nerve stem indications. We don't break that out. Another of our competitors, a big portion of their volume is just simply replacing their non-rechargeable batteries when they die. And that's a new procedure and a new device that gets sold. They don't break that out. We don't track that separately either. Look, we view it very clearly in terms of our growth, our total growth versus the market total growth. And if one exceeds the other, we know we're gaining share, revenue share. So I think the difference is how you're viewing PDN and total SCS market growth, and we just don't see it that way. I don't know, Rod, if you want to add anything to that.
spk13: Hey, Bill, just one thing to add. So our U.S. growth all in was 12%, and we think that's definitely at the front of the pack when you're looking at the U.S. SES space.
spk10: Okay, and then related to that is, you know, I think it surprised us the last quarter. You know, I know the core SES business you see down sequentially. And again, I guess this early in the launch, it was, you know, interesting that we saw even the PDN down sequentially. I just want to be clear with your comments that you expect the PDN component to grow quarter over quarter through both Q2, Q3, and Q4 of this year. Is that correct?
spk13: Yeah, that's how we're looking at it. You know, as we've discussed in the past, I would expect that Q3 will have some seasonality impact. relative to Q2, but we still expected to deliver some sequential growth in the PDN space just because of the growth trajectory and what's in the pipeline with patients in that business.
spk05: Great. Thanks for taking my question.
spk04: Your next question comes from the line of Robbie Marcus with JP Morgan.
spk14: Your line is open.
spk01: Hi, this is Alan on for Robbie. I just want to congratulate both outgoing and incoming CEO. You know, it's been a good run and hopefully can keep it going for a little while longer. But I guess, you know, when I think about 1Q market dynamics again, You know, there's obviously quite a bit going on with a new product launch. You've got some lingering challenges from COVID when it comes to staffing getting better. So when I think about, you know, the trends that keep you bullish on hitting your full year guide, you know, what trends are you seeing continuing into April that give you that confidence? And do we, you know, you gave some color in the guide, but how should we think about that generally trending through the balance of the year?
spk12: Yeah, generally speaking, and I'll ask Rod to join in with some color as well. I mean, generally speaking, we have a very specific and detailed view of how we think the year progresses month to month, quarter to quarter, and how that seasonality looks relative to prior years, what impact we think new product introductions, ASP changes, competitive entries, et cetera, will all play in that. And we evaluate our results, not only our results, but our competitors' results against that plan. And I think as we sit here in late April, we feel very good about what we've seen to date and the indicators for what's coming ahead of us in terms of that sequential breakout for the first quarter versus the second, the first half of the year versus the second half of the year, how that compares to prior years, the impact that we think PDN growth rates and IQ impact will make. And then we've seen our competitors' results, which speaks kind of to what we believe is happening and what we thought would happen in the overall market. So all of that gives us comfort that we're at least on track with the view that framed our guidance for the year. And just as maybe a general introduction, Rod, if there's anything in particular you want to add to that.
spk13: Yeah, just to add a little more color. So obviously you have Q1, you have our Q2 guidance, you have our full year. Mathematically, you're going to find Q3 and Q4 to drive to those full year numbers are going to be in that 11% to 15% growth range. You know, as Keith mentioned, as we modeled this out, we're looking at roughly a first half of the year constant currency growth of 8% to 9%. And we look at that second half of the year of 11% to 15%. We think we're really well positioned for that with the IQ launch, both from a volume as well as a pricing perspective. and the PDN expansion opportunity that we have in front of us. And then like Keith mentioned, you know, it's certainly nice to see some of our competitors posting some growth, which adds to the story that, you know, the recovery does look like it's starting to happen.
spk01: Got it. And then, you know, just thinking about the competitive landscape, you know, it feels like there was a little bit of a flurry of innovation over the last few years from your competitors. It's quieted down a bit. Now you're the one out with the new products. in terms of HSXIQ. Is there anything, you know, that you're seeing competitively on the horizon in innovation that you're keeping an eye on? Thank you very much.
spk12: Not really from our, I'm sure everybody will continue to innovate and broaden and deepen their stories. I think we have now another new on-label competitor in the PDN market. Certainly there's been no real fundamental change in that market since their approval because of its recency. And we don't expect it to have a really dramatic effect, certainly anytime in the near term. But we've got an eye on that situation, both of our competitors in that space, to see what they do to help us develop that market and to develop awareness among that referring and patient group. Beyond that, I think, you know, at least for the remainder of this year, any likely competitive change is, I think, probably more likely to come from new small entrants who are trying to break into this market. And we think that's likely to be, frankly, if any, the impact is likely to be much more in 24 than anything we expect to see in 23.
spk04: And our next question comes from the line of Richard Newitter with Truist Securities.
spk00: Hi, this is Sam on for Rich. Thanks for taking our question. I'll just ask both of ours up front. One, if you could give us any color on what you're seeing in terms of volume trends and accounts that have had access to IQ so far. And then just through the year, can you tease out at all for us the sequential ramp of IQ and its mix of overall implants. Should we expect 4Q to be close to 100% IQ? Thanks.
spk12: Yeah, I'll answer the first part of that and let Rod take the second part. I think it's too early. I mean, we just launched a product in March. I think, you know, it takes a little bit of time, I think, for account for doctors and for patients to really understand the technology to figure out how it fits in. We reported what we thought we could at this point in terms of the percent revenue contribution and the overall enthusiasm about the product and a little bit of anecdotal reaction. But give us a little bit of time. I think this team will come armed to the next earnings call probably with a bit more color and a bit more detail on market uptake and reaction to IQ. Anecdotally, I will tell you it's been It's been everything we hoped it would be. It's a very, very attractive product with a really interesting value proposition for our customers and for our patients and, frankly, for the company. Rod, do you want to add anything on the second part of that?
spk13: Sure. On the IQ mix, and we've talked about this in the past, what we're anticipating is a similar – ramp and mix to what we've seen in other products. And that usually takes in that six to nine month range to get to about 75% of mix of the new product. And we think that's a pretty good proxy for the IQ. And just one other note, even with the Omnia, that probably maxed out in about that 85 to 90% mix. you know, 12 plus months after product launch. So you never really get to 100%, but it's usually getting to kind of the high 80s once the product is well adopted and stabilized in the market.
spk04: All right, and we'll take our next question from the line of Adam Maynor with Piper Sandler.
spk02: Hey, Keith, Rod, and Kevin. Thank you for taking the questions, and I'll go ahead and echo the same sentiments as my colleagues on your departure, Keith and Kevin, assuming the role. So, maybe just regarding the Q2 guidance specifically, can you parse out PDN versus poor SDS growth expectations, and how do we think about growth in the quarter you know, versus the prior year given, you know, I know Q2 of last year was particularly hit by staffing challenges. So as you weigh that softer comp and some of those challenges easing versus, you know, market recovery and underlying growth in both SDS and PDN.
spk13: Sure. I'll take a crack at that. First of all, in general, we don't break out PDN. What we have said is that we do anticipate sequential growth in Q2 for PDN versus what we posted in Q1. As we're looking at the second quarter, and I'm going to actually bounce back a little bit and refer to what we said in our last earnings call, it's going to take a little bit of time for IQ to ramp up and have an impact. What that also means is that we're selling a greater mix of our legacy products, and we continue to have a little bit of pricing erosion there. As far as the growth in the quarter, that creates a little bit of softness. You mentioned the staffing shortages last year. Yeah, it does create a little bit of softness in the comparable, but we're also right in this in this period here we're ramping up IQ and we'll start to see that become a material part of our mix later in the year. I don't know if Keith you want to add anything on top of that?
spk12: I think that covers it pretty well. I mean if we keep in mind that when we give quarterly guidance as we have for Q2, the assumptions behind that are reasonably granular. Sure they're based on some of the macro assumptions about product line uptake, market growth rates, et cetera. But they're based fairly heavily on the trial rates that are already in the book. So we feel like we're not making quite as big a set of assumptions on Q2. Also, if you look at Q2, the easier comparable was probably in Q1 of last year with the Omicron. hit that Q1 took. The Q2 comparable from last year, while I would agree probably had a bit more staffing and infrastructural challenges in our customer base, was a stronger comparable than Q1. And that's part of our assumptions as well. If you look at the sequential lift from Q1 to Q2, and if you look at the combined first half of the year Q1 actual Q2 guidance, As a percentage of our total guide for the year, it's very comparable to the H1-H2 breakout from prior cycles. So I think all the ends kind of meet in the middle here, and we're comfortable with the Q2 guidance.
spk02: Okay, perfect. That explains it really well. And maybe for my follow up, how do we think about adjusted EBITDA growth over the course of the year? You know, now with the Q2 kind of guide in hand, it does seem like it's pretty heavily back half loaded. And, you know, just kind of thinking through some of the drivers in the business, you have ongoing clinical trials, you know, you're starting a new clinical trial, you're expanding the PDN referral. Salesforce and it does sound like you're going to kind of attack NSVP maybe a bit more aggressively in the second half of the year. So I guess like what are the primary leverage points that help us to get a bit more comfortable with that second half ramp?
spk13: Yeah, so there's a couple of things going on in the P&L as we go throughout the year. One is, as we've mentioned, IQ continues to be a greater part of our mix. That should help us from an ASP perspective. We've been pleased so far with the types of ASPs that we've been able to get with the IQ. And as that becomes a greater part of the mix, that'll certainly help with leverage on the P&L. Also in the fourth quarter, we start to... move product from our Costa Rica facility through our cost of sales, and that should also be margin expansive for the P&L. And then from an operating expense perspective, you know, we continue to manage our operating expenses in a, you know, we're always going to have a bias towards growth, but we manage them in a disciplined way. And Q1 traditionally is one of our higher quarters from an operating expense perspective. And I'd say this year is really going to be no different. So as we go throughout the year, there's going to be some puts and takes on the operating expense side of things to some of the points that you brought up as we expand in some key areas of investment. But we're also doing a you know, a really sound job of being disciplined in our approach, and that should enable us to be able to drive some pretty significant profitability in the second half of the year.
spk04: All right, and we'll take our next question from Matt Taylor with Jefferies.
spk09: Hi, good afternoon. This is Mike Sarkon on for Matt today. Thanks for taking our questions. Just the first one. You talked about pricing pressure in 4Q, and you've talked a little bit about degradation this year. I was hoping you could quantify what kind of price you're able to take with the new IQ launch.
spk12: We really haven't quantified that. I think that's... you know, that's not really information we want to give to our competitors. We talk about it in general terms. We do have some natural limits. We live in a, you know, a capitated reimbursement world and recognize the need for our hospitals and ASCs and doctors to be able to make a living as well. So we do have some upside limitation on the kind of premium we can bring to the market. But we have seen in the past a premium for meaningful innovation in this space. And some of our product introductions being, I think, right there among them. And we think that a premium is justified for what IQ brings to the patient and to the field. And that's what we've asked. So we think we've asked a reasonable pricing premium for the value that we're bringing to the patient and to the customer. But we've not quantified the amount in the past. I don't believe at all in the previous discussions we've talked about the percentage, have we? No.
spk09: Okay. Then I guess just on a broader level, understanding that you talked about IQ taking some time to ramp, but can you talk about at a high level for 2023, what kind of overall price looks like versus 2022 and what that could look like in 2024?
spk13: Yeah, I think what we've said in the past, and obviously it's going to vary by quarter as we've got IQ increasing as a part of our mix and legacy products decreasing. So from quarter to quarter, it will be different. But I think in the past, what we've discussed is that pricing is relatively flat on a year-over-year basis for the full year. And, but it has movement, you know, in a little bit of a degradation perspective early in the year and moving into a more positive one position in the fourth quarter.
spk05: Okay, thank you.
spk04: Again, if you would like to ask a question, press star then the number one on your telephone keypad.
spk14: Your next question comes from the line of Anthony Patron with Mizuho. Please go ahead.
spk08: Thank you, and I want to echo congratulations, Keith, on the transition, of course, and welcome, Kevin, and look forward to working with the team here. So maybe the first question, I guess, is just on the disclosure here, just on potentially moving away from disclosing each quarter, the PDN numbers. I'm just wondering from a high-level perspective, you know, sort of strategy shift and maybe even tactically as you think of investments. Should we be just thinking about just more focus back to the core pain markets, final court stem, even in the face here of the IQ launch and maybe a little bit of a slowdown in the investments in PDN, or is it still we should be, you know, thinking about just really a dual-pronged approach here just from an investment standpoint? And then I'll have a couple of follow-ups.
spk12: Yeah, well, I can tell you, and I'm going to defer to the judgment of the team in future quarters on this for sure, but I can tell you it has nothing to do with the enthusiasm or the prospects for PDN or the amount in which we'll invest in those prospects. So we continue to be very excited about the opportunity for PDN, the importance of PDN to the whole market and to the company. over time and we're going to invest behind that growth at a responsible rate. I think this has more to do with the things that I talked about earlier in our remarks. And we do have to be cognizant of the fact that we went from being the only one with a PDN claim to being one of three technically with a PDN approved claim. And so we're cognizant of the information we're giving, not just to you, but to our competitors. And to be honest, I think we just, we certainly don't want to put ourselves or our shareholders in a position where we're being penalized for growing the business. And I think what matters here is overall growth. Now PDN is part of that, but there's a lot of segments and a lot of parts of our overall growth that go unreported, and certainly all of them go unreported by our competitors. And so I think those will be the things that we take into consideration. And when I say we, I really mean Kevin and the team going forward. And I think the intent of our remarks was just to let you know this is something we're looking at. We probably never intended to break it out permanently. And they're going to be spending some time trying to evaluate how to communicate that going forward and if we make changes, what those changes are and when we make them.
spk08: And for the follow-up, it's just on the dynamics of the core spinal cord stim market and the dynamics there. Several quarters ago, the company talked about some patients that basically just fell out of the funnel because the diagnostic workup and the number of nodes that a patient had to get through was extensive, and then there was staffing headwinds. So when you think about just a renewed look at spinal cord stim, how many patients do you think have been lost? Do those patients come back? And if you will, when the market rebounds, what should we be thinking about? And just in terms of an underlying market growth rate, can it return to a high single digits? Is it a mid single digit grow or a, can we potentially see at some point a low double digits? Thanks.
spk12: Yeah. Um, well look, we, we, um, We gave up a long time ago if we ever really thought we could trying to quantify pent-up demand over the course of the pandemic. That's a little bit of a fool's error. And I think early on we did try to identify the delta between where the market would have been in overall size absent the pandemic and where it was and discussing the magnitude of that delta. But in terms of trying to quantify the actual pent-up demand and especially that portion that returns to this therapy, we have found, and not for lack of trying, that that's quite a difficult thing to do. I do think we're seeing in this space, in terms of patient visits, which we talked about in our remarks, and we're seeing it in comparable procedures around the industry, that there is clearly the view, at least, that part of what we're seeing is some pent-up demand of patients coming back in to the funnel for various procedures that probably were deferred or delayed from prior time periods. And I don't doubt that that's the case. I just will tell you that I think it's very hard to quantify. From a future growth rate standpoint, yeah, I actually think we are, there's, look, the pandemic has done a very good job of baking in a lot of pessimism the way people think about certain markets. We've tried very, very hard to analyze along the way the real fundamentals of this market and to what extent anything else is changing. And as you know, we've had a very difficult time pinpointing other fundamental changes in this market except those that came with pandemic environment. So we continue to be bullish about the long-term growth rates of this market. Now, what those growth rates are, I mean, historically they've been reasonably variable, you know, going from low to mid single digits up to up to mid teens. I think the answer is probably somewhere in between, not surprisingly. But you asked the question, could this market be an overtime grower of, say, high single digits? Absolutely, it could. Could it go through periods where the whole market grows in the double digits? Certainly that it could. I don't know that I would expect that to be the norm over, say, a 10 year period. But I think historically, you look at any 10-year period in this market, and it's, you know, mid to high single digits is kind of the norm. And I have every confidence this market can return to that.
spk08: Appreciate it. Thank you again.
spk05: Congrats to everyone on the news. Thank you.
spk04: There are no further questions at this time.
spk14: I would now like to turn the conference back over to Kevin Thornhill for closing remarks.
spk07: Thanks, Lisa. Let me close by reiterating how delighted I am to be joining Nevro at this exciting time. I look forward to reporting on our progress on our next call, armed with my first quarter as CEO underneath my belt. Thanks, everyone, for joining the call today.
spk04: And that concludes today's conference. You may now disconnect.
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