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spk04: Good afternoon. My name is Audra, and I will be your conference operator today. At this time, I would like to welcome everyone to the NEVRO First Quarter 2024 Earnings Conference Call and Webcast. Today's conference is being recorded. 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 the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. At this time, I would like to turn the conference over to Angie McCabe, Vice President, Investor Relations and Corporate Communications. Please go ahead.
spk00: Thank you, Audra. Good afternoon and welcome to Nebro's first quarter 2024 earnings conference call. With me today are Kevin Thornall, our CEO and President, and Rod McLeod, our Chief Financial Officer. Before we get started, please note that our earnings release and the supplemental presentation accompanying this call are available on the events and presentation page of the Investors section of our website at Navarro.com. Also, this call is being broadcast live over the internet to all interested parties, and an archived copy of this webcast will be available in the Investors section of our corporate website shortly after the conclusion of this call. 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. Results could differ materially from those expressed or implied as a result of certain risks and uncertainties. Please refer to NEVRO's SEC filings, including our annual report on Form 10-K for detailed presentations of risks. The forward-looking statements in this call speak only as of today, and the company undertakes no obligation to update or revise any of these statements. In addition, management will refer to adjusted EBITDA, a non-GAAP measure used to help investors understand NEBRA's ongoing business performance. Adjusted EBITDA excludes interest, taxes, non-cash items such as stock-based compensation, depreciation and amortization, litigation-related expenses and credits, changes in the fair market value of warrants, and other adjustments such as gain from extinguishment of debt and restructuring charges. Please refer to the financial tables in our earnings press release issued today for reconciliations of GAAP to non-GAAP financial measures. I will now turn the call over to Kevin. Kevin?
spk01: Thanks, Angie. Good afternoon, everyone, and welcome to our first quarter 2024 earnings call. A short time ago, we reported our first quarter results with revenue-adjusted EBITDA exceeding the guidance we provided on our fourth quarter 2023 earnings call in February. We also announced we are taking additional restructuring steps to further advance our strategy and accelerate our path to profitability, reaffirming our full-year 2024 revenue guidance, raising our 2024 adjusted EBITDA guidance to a range of negative 5 million to positive 2 million, and providing our second quarter 2024 guidance. In addition, I'm thrilled to announce that Chris Christofor, O, has been promoted to Chief Operating Officer. On today's call, I'll discuss the progress we are making in advancing our three pillar strategy, including highlights from the first quarter and the additional restructuring actions. Rod will then discuss our first quarter financial results and provide more detail on our guidance for the second quarter and full year of 2024. In the first quarter, we continue to advance our three pillar strategy of commercial execution, market penetration, and profit progress, and this is reflected in our overall results. For the first quarter of this year, and as compared to the year-ago period, worldwide revenue was $101.9 million, an increase of 5.8% on a reported basis and 5.6% on a constant currency basis. This year-over-year growth was largely driven by a product mix shift to our newest generation SES platform, HSX IQ, as well as an increased number of long-term Nevro patients who are now suitable candidates for a replacement device. As a reminder, our devices have rechargeable batteries with a very long functional life. And even in this case, we believe these devices will eventually require replacement. Our earliest patients are now out about 10 years or more. We believe many of our patients will want to continue accessing our unique and successful high-frequency therapy through a newer Nevro device. While this is currently a small part of our SES business, we believe it may play a slightly larger role in our implant volumes over time. U.S. trials were down approximately 5.1% compared with the year-ago period. This was largely in line with our expectations and mainly driven by two factors. First, softness and overall U.S. SES trialing activity in the quarter, and second, the impact of interest among SES customers in attending our SI joint fusion training sessions, which take physicians out of the practice for a day or two. In fact, we added more training sessions in the quarter to accommodate physician demand to learn this procedure. We are conducting additional SI joint training sessions throughout the second quarter and the remainder of the year. From a cadence perspective, and Rod will discuss our guidance in a few minutes, revenue in the first half of this year is on track with our expectations. This combined with several factors such as one, our continued focus on growing our SES business by selling our superior therapy to competitive physicians. Two, growing the market through our expanded indications such as PDN, which continue to show solid growth in the quarter. Three, beginning to realize early results as our SI joint business gains traction in the second half of this year. And four, leveraging our SI joint business to sell more SES devices into competitive accounts. It gives us confidence that we can achieve our full year revenue guidance of $435 million to $445 million. We also reported a net loss from operations of approximately $35.8 million and adjusted EBITDA of negative $9.6 million. As it relates to the first pillar of our strategy, commercial execution, in the first quarter, sales reps who joined Nevro in the second half of last year continued to ramp up on the business, and we commenced the limited market release of our SI joint products. We also continued to focus on educating our customers on the benefits of our superior SES therapy. We are driving the increased adoption of HFXIQ, our newest generation SCS system that brings a multitude of benefits to the patient and physician. HFXIQ represented 58% of our total permanent implants in the first quarter, a 5% increase from the fourth quarter of 2023. To broaden access to this therapy for more patients, in mid-April, we launched a solution for nearly half of the patients who do not have a compatible iPhone, including those with an alternative smartphone device. As we've previously communicated, our real-world data shows that our HFX IQ system, in combination with the cell phone app, helps patients get back to pain relief faster than those who use a traditional remote by allowing the patients to have more input on and control over their therapy. We expect continued HFX IQ adoption as we educate the market on the benefits of this therapy. We also continue to advance our second strategic pillar of market penetration, where our focus is on expanding into new indications, developing and launching enhancements to our HFX IQ system, executing on our robust R&D pipeline, and, as appropriate, targeting additive acquisitions to drive profitable growth. In the first quarter, we focused on integrating our newly acquired SI joint fusion business and, as I just mentioned, commenced the limited market release of our SI joint products and prepared for the broader release of our SI joint products to the market throughout the remainder of this year. By expanding our product portfolio to include solutions for SI joint pain, we are now engaging with physicians who have not previously utilized our products to now offer treatment options for patients with different chronic pain conditions. Notably, We believe that 15 to 30% of low back pain is caused by SI joint dysfunction. In the U.S., approximately 1.9 million patients receive an SI joint diagnosis annually, representing a $2 billion market opportunity. Through this expansion in therapeutic options for pain patients, we are now able to address more patient needs and leverage our SI joint solutions into business at competitive SES accounts where we previously did not have access. During the quarter, we conducted several SI joint fusion training sessions for physicians and our sales reps with a primary focus on NEVRO-1, a standalone device with integrated transfixing technology that has proven to immediately transfix the SI joint to allow the opportunity for long-term fusion. Year-to-date, more than 220 physicians participated in our SI joint training sessions. Many of them are current customers who took the time to learn a new SI joint fusion procedure so they can utilize our innovative products to treat their patients suffering from chronic pain. Early feedback from physicians who attended our training sessions has been very positive, and they believe Nevro-1 is an excellent treatment option for patients suffering for SI joint pain. We continue to see significant physician interest and demand for training on our SI joint products, particularly Nevro-1. As we roll out our SI joint products across the market, many of the physicians that we trained are identifying patients in their practice who suffer from mechanical back pain that could benefit from an SI joint fusion procedure. Importantly, we continue to train our sales force and are leveraging our commercial team to drive adoption and growth. Also, as adoption of our SI joint products increases, we will gain greater access to physicians who might be interested in using our SES products to treat their patients. as many physicians who perform SI joint fusion procedures also implant SCS devices. We are also thrilled that in February, the Food and Drug Administration granted 510 clearance for NEVRO 1 without the need to include the NEVRO fixed group. This marks the first regulatory clearance since we acquired Versa late last year. NEVRO-1 as a standalone device represents a significant advancement in SI joint fusion, and we believe it is the most efficient, effective, and safest SI joint fusion implant currently available on the market. As a healthcare company with a vision to free patients from the burden of chronic pain, we remain focused on increasing awareness of SCS as a treatment therapy for painful diabetic neuropathy, or PDN, and other indications. At just under 1%, the PDN market remains significantly under-penetrated, and we are working to develop this market with our innovative technology and superior clinical data. Diabetes is a major global public health concern and continues to grow in prevalence. It can lead to a variety of complications, including nerve damage, reduced circulation, diabetic ulcers, and limb loss. In the first quarter, 24-month data from our CINZA PDN-RCT demonstrate improvement in sensory function that could lower the risk of diabetes-related ulcerations and traumatic amputations for patients suffering from severe side effects in diabetes was published in the Journal of Diabetes Science and Technology. We continue to be a leader in developing superior clinical data showing the efficacy of our best-in-class 10 kilohertz technology. As we've discussed on prior earning calls, our PDN clinical sensory study is designed to more objectively prove the sensory improvements that we observed in our initial randomized controlled trial, or RCT, and to obtain an SES indication beyond just pain. We're pleased to share that enrollment in this study now stands at 143 patients ahead of our plan. As a result of this robust enrollment and the strong outcomes demonstrated in our CINSA RCT, we are pausing enrollment in the PDN Sensory Study to allow for an interim primary endpoint analysis of all subjects who are randomized from this existing cohort. While the results of the analysis may indicate restarting enrollment in the future, our goal is to bring trial results to publication as soon as possible for the benefit of patients and review for inclusion in therapeutic guidelines. The third pillar of our strategy is profit progress. We remain focused on executing key initiatives to become more efficient, scaling our Costa Rica manufacturing facility and maintaining disciplined expense management to expand margin and achieve profitable growth. We made good progress on this front in the first quarter as demonstrated by adjusted EBITDA coming in ahead of our expectations. We are taking additional restructuring steps to make Nevro a stronger, healthier, and nimbler company so that we can advance our three pillar strategy and accelerate our path to profitability. We are laser focused on managing our expenses and aligning our cost structure with our business and have identified areas and key initiatives that we believe will drive growth and profitability. We continue to invest in our R&D pipeline to develop and commercialize innovative treatment therapies for patients suffering from chronic pain. Rod will discuss our full year guidance in more detail, but as a result of our first quarter performance, additional restructuring steps, and outlook for the remainder of this year, we are raising our adjusted EBITDA guidance to a range of negative 5 million to positive 2 million. As part of these steps, I'm thrilled to announce that Chris Cristoforo has been promoted to the newly created role of Chief Operating Officer. In addition to his current responsibilities leading our manufacturing processes and research, development, and innovation efforts, as well as spearheading the integration of Versa into our operations, Chris will now have oversight of clinical and regulatory affairs and quality assurance. Chris has been with Nevro for eight years, and during this time, he has proven to be a valuable member of our team. His strong leadership skills, technological experience, and deep knowledge of the med tech industry make him the right choice to serve in this role. We continue to transition more of our manufacturing to our Costa Rica facility, and as we sell down inventory that is produced by our second source supplier and manufacture more in Costa Rica, we expect to see increased margin expansion over time. We will also leverage our Costa Rica facility, which is supported by best-in-class manufacturing experts and technology as we grow our business through new products we develop as well as tuck-in acquisitions. In summary, over the past year since I joined Nevro as CEO, we've made significant progress in advancing our three-pillar strategy to further position our company for the opportunities ahead of us. We're excited about our future as we have multiple growth drivers in the SES market, including through expanded indications as well as the SI joint fusion market. We entered the fast-growing SI joint fusion market through our acquisition of Versa and are focused on ramping up that business. We will continue to differentiate ourselves through our unique 10 kHz technology that produces superior outcomes. And we will continue to capitalize on meaningful leverage opportunities to drive long-term profitability, generate positive cash flow, and deliver shareholder value. I will now turn the call over to Rod for a discussion of our first quarter financial results in 2024 second quarter and full year guidance.
spk08: Thanks, Kevin. And good afternoon, everyone. To echo Kevin's remarks, we're pleased with our first quarter 2024 performance as we made further progress on advancing our three-tiller strategy. For the first quarter of 2024, as compared with the year-ago period, worldwide revenue grew to $101.9 million, an increase of 5.8% as reported, and 5.6% on a constant currency basis, and was primarily driven by a mixed shift to higher-priced products, as well as a growing number of patients who are now suitable candidates for a replacement device, as Kevin discussed earlier. Also, there were 64 selling days in both the first quarter of this year and last year. U.S. revenue grew 5.7% to 87 million. International revenue was 14.9 million, increasing 6.1% as reported, or 4.7% on a constant currency basis. Gross profit increased 10.7% to $71.5 million, and gross margin increased 310 basis points to 70.2%, driven primarily by a shift to higher margin products that are manufactured in our Costa Rica facility. Operating expenses increased to $107.4 million compared with $100.9 million in the prior year period and included the impact of the following items. First, a $5.5 million charge related to our January 2024 restructuring, and second, two VERSA acquisition related items comprised of a $3.5 million charge related to the change in fair value of the contingent consideration liability, as well as $700,000 of intangibles amortization. Excluding these items, operating expenses decreased approximately 3.3% versus the prior year quarter, reflecting our ongoing focus on discipline expense management and driving operational efficiency throughout the organization. Litigation related legal expenses were $2.8 million compared with $3.8 million in the first quarter of 2023. We are pleased with the recent ruling in our favor in our arbitration against the Mayo Clinic and Flathead Partners. We now consider the matter concluded with no finding of liability against Nevro. Cash equivalents and short-term investments were $281.5 million at March 31, 2024, a decrease of $41.2 million from December 31 of 2023. This decrease was primarily due to customarily higher cash outflows that occur in the first quarter, a $9.8 million Versa-related milestone payment made in the quarter related to the FDA 510 clearance that Kevin discussed earlier and that was achieved sooner than we anticipated, and $4.4 million in restructuring related payments. As Kevin discussed in his remarks, in the first quarter we focused on training physicians and the salespeople who support them in performing SI joint procedures using our portfolio of SI joint fusion products. We are in the early phase of ramping up this business and will continue to train physicians and our field force throughout 2024. As a result, we anticipate that the second half of this year will begin to reflect increasing revenue traction in this business. As we communicated previously, while we continue to expect the VRSA transaction to be accretive to both revenue and adjusted EBITDA this year, we also expect the revenue contribution from our SI joint business to be immaterial to the overall year. Turning now to our 2024 full year and second quarter guidance. First, for the full year 2024, we continue to expect worldwide revenue of approximately $435 million to $445 million. This reflects our outperformance in the first quarter, our expectations for the second quarter, which I will discuss in a moment, and our outlook for the second half of 2024. We expect gross margin to be approximately flat with 2023 gross margin of 68%. Our Costa Rica manufacturing facility continues to produce excellent results with low labor and material costs for manufactured products. We remain excited about the cost improvements Costa Rica can deliver, and we continue to project long-term gross margins in the mid-70s, assuming pricing holds at current levels. We expect our full year 2024 operating expenses to be approximately $390 million and largely flat compared with 2023. Keep in mind that our 2024 operating expenses also include restructuring related charges of $10 million, Versa related amortization and milestone revaluations totaling $6.5 million, and key SI joint investments as we continue to scale this exciting new business. Excluding the above items, we expect our operating expenses to be down approximately 7% on a year-over-year basis. In total, we expect our January and May 2024 restructuring efforts to generate savings of more than $25 million in 2024 and full-year annualized run rate savings of well over $30 million. And as we mentioned in our Q4 2023 earnings call, through our restructuring and other efforts to drive improved efficiencies and expense management, we are redirecting portions of our resources to key areas of our business, such as adjacent technologies, next generation R&D projects, investments in PDN, and SI joint-related investments to deliver a world-class transfixing solution to patients. We are laser focused on aligning our cost structure with our business and are taking additional restructuring steps to reduce our costs, improve efficiencies, and focus our resources on executing our strategic priorities. Given our outperformance in the first quarter and the actions we are taking this year to accelerate our path to profitability, We are raising our adjusted EBITDA guidance for the full year to be in the range of negative 5 million to positive 2 million, which roughly reflects a 9 million to 10 million dollar improvement in adjusted EBITDA compared to the guidance we provided in February 2024. For the second quarter of this year, we expect worldwide revenue to be in the range of approximately 106 million to 108 million dollars, which is in line with our expectations for the first half of this year. As we have previously communicated, the SES business can be a bit lumpy. While we are pleased with our first quarter performance, which exceeded our expectations, we still believe that our first half will largely finish in line with our initial expectations of approximately $208 million to $210 million, which is up 1.4% to 2.4% for the first half of this year, versus the prior year period. We expect second quarter 2024 adjusted EBITDA to be in the range of negative 3.5 million to negative $2.5 million. In closing, we are pleased with our first quarter performance and are excited about our future. We know we have more work to do and we remain committed to executing our strategy, operating with an eye toward achieving profitability by capitalizing on the significant growth ahead of us and aligning our cost structure with where the business currently stands to deliver value to our customers, the patients they serve, our employees, and our stockholders. Audra will now open the call for questions.
spk04: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. We ask that you please limit yourself to one question and one follow-up to allow everyone an opportunity to ask a question. We'll take our first question from Joanne Wench at Citi.
spk10: Good afternoon. This is actually Anthony on for Joanne. Thank you for taking our questions. I guess the first on guidance, just given where the second quarter is, it implies a deep acceleration in sales in the back half of the year. And then similarly for EBITDA, can you just maybe talk about what gives you confidence both in the revenue and the EBITDA number? Maybe just talk about some of the cost cutting you're pursuing. Thank you.
spk01: Yeah, thanks for the question. Yeah, so we do have it rampant in the back half of the year. As you recall, this business has a lot of seasonality with the fourth quarter always being substantially the biggest quarter of the year. So we predict that seasonality will continue. We also obviously have our SI joint business that will provide a little bit of tell wins to us as we get into the back half of the year. And also, don't forget last year we had a pretty big change in our sales force and people were hired towards the back end of 2023. So they're still ramping up as the year goes on and a lot of those newer reps are starting to hit their stride out there in the field. And we also, as we indicated, you know, it's still a small portion right now, but we have the people that have had a previous Nevro device that are coming back to continue their therapy after, you know, maybe 9, 10, 11 years of great success in the treatment. They'll want to continue that therapy. So we see that progressing as the year goes on as well.
spk10: Thanks. And just a quick follow-up on your second point on the replacement opportunity. How much of that is baked into guidance for this year?
spk01: Yeah, everything, you know, trials and replacements and competitive conversions and new patients are always baked into the guidance. So it's all baked in right now. We're not going to get into calling out. It's a really small part of our business right now. And so, you know, we'll continue to include it as we give our guidance for the rest of the year.
spk06: Got it. It's helpful. Thank you. Yep. We'll go next to Nathan Tradeback at Wells Fargo.
spk03: Hi. Thanks for taking the question. Just can you provide a little more color on your 24 guidance assumptions? I mean, you beat Q1 by about 4 million, but you didn't raise the full year guide. And Q1 was also your toughest comp of the year, I guess. Are you assuming Q2 through Q4 lower than your initial outlook?
spk08: yeah i mean just just mathematically we over delivered in q1 and we're holding the whole the the full year at the same level so so yeah you're correct um we we feel like q1 was was it was a touch stronger than what we were anticipating and we're really as we look at the first half of the year it's still really coming in line with how we initially thought the first half of the year would play out so with the first quarter being a little bit stronger, the second quarter is just a touch softer than maybe what we would have projected when we put that Q1 guidance out.
spk03: Okay. And can you provide a bit of color on the additional restructuring stuff that you're taking, and do you expect more disruption from this over the rest of the year?
spk08: Thanks. The short answer is no, we don't expect much in the way of disruption. A lot of this was just driving increased focus on the projects and the strategies that, as an organization, we're really going after. And, you know, we were able to shed about $25 million in projects in reductions for this year alone and on an annualized basis, it's north of $30 million. So a lot of good work by the team to just drive focus on really the key aspects and strategies of this organization.
spk06: Okay. Thanks.
spk04: Our next question comes from Robbie Marcus at JPMorgan.
spk12: Hi. This is actually on for Robbie. Thanks for taking our question. I just had a couple questions. First on Versa, I know you mentioned that you expect kind of tailwinds from the SI joint business in the second half of the year. Can you elaborate a little bit more on how much of that is baked into the guidance? I mean, I think some prior commentary pointed to roughly 20 million in sales. How should we think about that just for the full year and also just quarter to quarter? That would be helpful.
spk01: Yeah, thanks for that. We're excited about Versa, but it is still a non-material part of our business. We have never put out a number that's a $20 million number, so I want to make sure people don't think that we gave out any of those numbers because we haven't. We still have to scale that business. A lot of it is around the internal scaling of making sure we have the trays that are utilized for the procedure and ramping those up so our sales reps can have them available to them and available for the procedures. And we also are making sure that we train physicians and our sales reps the right way. We go through a pretty exhaustive list of things that the reps have to show before they can start to cover some cases by themselves. And so it's going to take us some time to continue to get all of our sales rep up to speed. But as I mentioned, right now we've trained over 220 physicians, and the waiting list was much bigger than that. So we'll continue to add on SI joint training classes, but it does take time for physicians after they get trained to go back, identify patients, and start doing those procedures. So we're excited about it, but it's nowhere near that size of the business as we move on through the year. As we said, it's going to be an immaterial part in 2024.
spk12: Got it. That's really helpful. And then the second one is just on gross margin quickly. You had a pretty solid gross margin in the quarter, came in ahead of expectations, and still kind of expecting it to be roughly flat for the full year with 2023. So can you just walk through why you expect the sequential decline, just given you had a strong quarter? You mentioned that a lot of it was due to the Costa Rica manufacturing ramp, which obviously should continue throughout the year. So just talk to some of the puts and takes there. That would be helpful.
spk08: Yeah, if you, happy to. It's a good question. And if you happen to go back to our last quarter, we walked through this a little bit as well on the call. But basically, as we're in this transition phase, moving from contract manufacturers to sourced product out of our Costa Rica manufacturing plant, There's going to be a couple of months where some of the variances associated with the overheads will hit in a little bit of a meaningful way in the second half of this year. And this really has to do with, you know, prior year when volumes and some of the mix shifted. So we're going to take a little bit of a, you know, we're going to see some of those variances flow through in COGS in the second half of the year. But our long-term prognosis for the costs out of Costa Rica are still super strong. The labor rates are good. The material costs are good. And we're just going to have to work through a little bit of these choppy waters as we're transitioning from the contract manufacturer to Costa Rica manufacturing.
spk06: Great. Thank you. Next, we'll go to Shagun Singh at RBC.
spk09: Hey, this is Avion for Shagun. Could you discuss the health of the spinal cord stimulation market in some detail? What's contemplated in your 2024 guide, and what can we expect never to get back into a share-take position? Thanks.
spk01: Yeah, you know, look at the, we commented on the trials in the first quarter being largely in line with what we expected because some softness in the trialing. What we know right now from the public companies that have announced is, you know, there's really two of us that grew in the quarter. One of our competitors announced being down in the quarter, but we believe there's a couple of private players that are also up. So three or four of us actually grew in the first quarter, so that's encouraging. As far as what's baked into the guidance, all of our trialing, replacements, everything we talked about is baked into the guidance for the year, including ramping a little bit to our SI joint business in the back half of the year, our sales reps ramping up throughout the year that were hired at the end of last year. as well as those replacement cycles still likely going to be strong for those patients that have had unbelievable success with our technology over the last 10 years. And so you add those all together and they're all baked into the guidance and why we feel good about reconfirming guidance for the year.
spk06: Great, thanks.
spk04: We'll move next to Bill Plavonic at Conocore Genuity.
spk02: Hi. This is Zachary on for Bill today. Thanks for taking the question. On Versa, was there any impact on Q1 revenue from that? I understand that you trained over 220 physicians. Were there any that saw any volumes that impacted revenue?
spk08: Yeah. As we mentioned, we picked up a little bit of revenue from our SIJ business, but it's immaterial. and it'll continue to be a material as we're ramping up that business.
spk02: Got it. And for my follow-up, you mentioned having R&D programs, new tech on the way, and PDN. Could there be any integration with, you know, closed loop within your portfolio?
spk01: Yeah, so one of the things, just a quick technology statement, sort of education here. So high-frequency closed-loop is not needed. So closed-loop technology that Medtronic now announced and one of the private players has out there is basically to ensure that as the lead is next to the spinal cord, if it moves closer to or further away, that you don't get over-therapy and, you know, maybe provide a little zap or further away and moves further away where you don't have good enough therapy. That's their way of really turning up the volume up or down based upon where that lead is placed. We don't have that problem with high frequency. It's like asking, you know, a Tesla owner, where's their gas tank? Um, we don't need one of those, uh, on high frequency because we already with doing pair of pairs, these are free. Um, we don't have to map the patient. And as a result of that, uh, we've always had great, um, parts of FDA approval where you can drive a car with our therapy. You can go out and have do activities with our therapy because we don't have any of those jolts or reduction in therapy based upon the lead location.
spk04: We'll move next to Anthony Patron at Mizuho Group.
spk07: Thanks. Appreciate the fitness and our questions here. A little bit just on the competitive dynamics and have a follow-up on gross margin. Maybe just a little bit on Abbott's presence there with the Turner. They obviously have a potential synergy there with their Libre franchise on the diabetic side. Just wondering if they've changed the dynamic on the PDN side you know, with Eterna potentially side by side with Libre and then have a quick follow up on gross margin.
spk01: Yeah, so we've not seen that out there. You know, that could be some potential where they would want to partner. You know, we still stand by our clinical superiority that we have and the claims that we have with 10 kilohertz specifically for PDN patients. If you think about it, and I've said this before, These PDN patients that suffer from painful diabetic neuropathy already have severe tingling and numbing in their legs. The last thing you want to do is add additional paresthesia to those patients. And with high frequency, we don't have paresthesia. That's not how our technology provides pain relief. And so it's a perfect choice for physicians treating PDN patients. You can see that we've trained a ton of physicians that have these types of patients in their practice. We have a sales force that's out there educating those referring physicians into pain management offices, and we believe we'll continue to have superior outcomes clinically, as we talked about in the earnings script. with pausing our sensory study we believe we may have a chance to have a powered study to be able to get additional claims uh in that space and we know that we're the only ones doing that clinical work so we believe we're still going to stand strong in that pdn market and lead the way and just quick one on gross margin fault maybe looking beyond 2q you do have hfx iq at a at an asp uplift and and costa rica is going to be a meaningful contributor going forward
spk07: Just as you look ahead beyond 2Q, I mean, how do we think about those two dynamics playing out in the second half and maybe even to 2025, the gross margin uplift from higher ASP and then Costa Rica manufacturing? Thanks.
spk08: Yeah, it's a good question. There's a couple of factors at play, and the way you're framing it is directionally right. One, the mix will continue to shift towards IQ. As Kevin mentioned, we finished Q1 about 58%. That was up from 53% of our mix being IQ, 58 in Q1, 53 in Q4. So that mix shift will continue, especially as we've been able to offer a solution to the Android users out there to use the app with IQ. We are picking up a little bit of a pricing premium on that product, and we expect to continue to do that. For the second half of the year, as I mentioned earlier in the call, though, we are going to have a little bit of pressure on the COG side as we have to run some of the variances through the income statement and through COGS in the second half of the year. But as we get into 2025 and beyond, that's when we start to see, assuming the pricing holds, that there's some really strong opportunities to expand margins in 2025 and beyond as the costs are coming in right in line with really how we think that this will play out over time. As I mentioned, labor costs are solid. Material costs are in the range that we expected. So we continue to be really excited about the sort of quality and the scale that Costa Rica's
spk06: delivering for us. And we'll move next to Carolyn Huzag at Bank of America.
spk05: Hi, this is Carolyn on for Travis. Thanks for taking my questions. I wanted to follow up on the SI joint training disruption in the quarter. You've mentioned additional training sessions in the second quarter and then continuing throughout the year. Can you put a finer point on the cadence there? What do you expect for disruption in the second quarter when it comes to SI joint training relative to first quarter? And how does that disruption in the second half compared to first half? Thank you. And then I have one follow up.
spk01: Sure. Yeah, most of these courses we do over the weekend. But a lot of times physicians have to travel in on a Thursday night or maybe a Friday, depending upon where they're located to come to some of our larger trainings. We will eventually ship those out to more of a regional training, but right now our best effort is to be able to bring in a large number to each of these training sessions. So it's baked in already to our guidance. We're not going to break out, like, what percentage. It's just a part of the overall. And we know it's the right thing to do as these patients can benefit from having mechanical back pain relief on top of their neuropathic back pain relief that we have for our SES products. And obviously, while they're there... we have a chance to talk to them about our SES therapy. So we're not missing out on a great opportunity to keep driving our superior technology and educating our physicians around it, but it does take physicians out of their office for a day or two, and they'll obviously miss some trials as a result of that. It's not a massive number, but we just wanted to call it out as we know it had an impact within the quarter and likely a little bit in Q2 as well.
spk05: Got it. Thank you. And then just putting a finer point on the source of the disruption between training nevrosales reps versus training the doctors. Should we think about this disruption as more of a one-time impact as your reps get up to speed and then we move past it? Or is this, I guess, perpetually a little bit more disruption than you expected previously? Is it your expectation that you would continue to take doctors out of the clinic for a day or two moving forward to get them up to speed on SI joints? Thanks again for taking the question.
spk01: Yep, so what we're doing is we're actually training our physicians and their sales rep at the same time. So we're getting a two-for-one versus separating those trainings. And so we're able to have the physician and their sales rep stand side by side and making sure that they're training appropriately. So when they go back together to their practice, they can perform that procedure just like they did on a model or cadavers. And so we are getting sort of two-for-one as we do these training sessions. And most of our sales reps right now, we're working through getting at least one person in each territory where they're sort of certified as we call it to make sure that they can cover cases appropriately and we're well on our way to do that so it's really a bolus of training right now where we have a lot of our nevro scs and planning physicians that wanted to be first in line to really train for si joint and and we made sure that they were sort of front of the line there and our sales reps that covered those territories were sort of the first in for training We believe that by the end of Q2 and throughout Q3 a bit, we'll get the majority of our sales reps up to speed where at least one person in that territory can help cover those cases.
spk06: Thank you. We'll go next to Justin Lin at William Blair.
spk11: Hey, good afternoon, guys. Thanks for taking questions. First one on HFXIQ, what's the timing in terms of getting it available on Android like you talked about? And are there any other levers that you can kind of pull to accelerate that growth on top of the Android dynamic?
spk01: yeah so we just launched an opportunity for patients that had an android it's not on their device it's a locked iphone that they're able to utilize for the for the treatment and that way it stays consistent across all of our customer base as a reminder we're we're the only company that has ai inside of our technology with our algorithm because of the 100 000 plus patients they're in our database And we want to make sure that that data that we get from all of our patients, we keep learning and our algorithm keeps adapting based upon how patients are receiving their treatment. And that treatment's personalized for them. So we just launched that within the quarter, and that's being rolled out across the U.S. right now.
spk11: Gotcha. Second follow-up question just on PDN. I know you're no longer kind of bifurcating out the PDN business. But any qualitative color you can give there, you know, how's the business trending relative to your expectations?
spk01: Yeah, I came in right in line with our expectations are still strong, still have a ton of interest in it. And again, we're still around 1% penetrating in that market. And so we're out there educating every day on the benefits of the therapy. and ensuring those referral networks are set up. So it will continue to still be a strong part of our business moving forward. But it came in right in line with our expectations and it was still strong.
spk06: Got it. Helpful. Thank you. And next we'll go to Brad Bowers at Mizuho Securities.
spk13: Hey, thanks for fitting me in. Just wanted to follow up on one from Mizuho and on behalf of Anthony. I just wanted to go back to the Versa strategy. You know, it sounds like a lot of the work being done right now is on existing Nevro physicians and getting them trained, you know, but it sounds like the longer term or medium to longer term strategy is for Versa to be used as kind of a door opening tool, you know, to get into practices where Nevro, you know, maybe isn't the majority choice for SCS. So just wanted to hear when you think you'll be able to kind of switch to Salesforce to focus on new accounts and leading with VersaSI, you know, to try to take some market share back in the pain practices, you know, is that something that will be maybe a help for numbers this year? Is that something that maybe we should, you know, consider more of an extra item? Thank you.
spk01: Yeah, for sure. I mean, a lot of our sales reps have already taken advantage of the opportunity to have conversations with physicians that maybe had told them no over a period of time, and now they have something new to talk about. So we're excited about getting those physicians in the queue for training. Obviously, the results we were talking about today were a lot towards Q1, but as we're already into Q2, the mixed shift of physicians attending our trainings are including all comers. So, NEVRO physicians that have put SES and NEVRO devices in for a decade and some that are implanters of other devices for SES and also learning the NEVRO-1 device. So, we will do a lot of both.
spk06: Thank you. Yep, thank you.
spk04: And that does conclude our Q&A session and today's conference call. We thank you for your participation. You may now disconnect.
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