NASDAQ:CVRX CVRx Q3 2025 Earnings Report $6.11 0.00 (0.00%) Closing price 05/22/2026 04:00 PM EasternExtended Trading$5.94 -0.17 (-2.83%) As of 05/22/2026 06:26 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast CVRx EPS ResultsActual EPS-$0.49Consensus EPS -$0.50Beat/MissBeat by +$0.01One Year Ago EPSN/ACVRx Revenue ResultsActual Revenue$14.69 millionExpected Revenue$14.16 millionBeat/MissBeat by +$534.00 thousandYoY Revenue GrowthN/ACVRx Announcement DetailsQuarterQ3 2025Date11/5/2025TimeAfter Market ClosesConference Call DateWednesday, November 5, 2025Conference Call Time4:30PM ETUpcoming EarningsCVRx's Q2 2026 earnings is estimated for Tuesday, August 4, 2026, based on past reporting schedules, with a conference call scheduled on Monday, August 3, 2026 at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by CVRx Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 5, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: CVRx reported Q3 revenue of $14.7M, up 10% year‑over‑year, with more sales reps contributing than ever, 250 active U.S. implanting centers and 10 net new centers added — indicating accelerating commercial traction. Positive Sentiment: Significant reimbursement progress — CMS proposed mapping to APC 1580 (~$45,000 outpatient payment) and finalized the move to a Category One CPT code effective Jan 1, 2026, which should reduce automatic denials and improve prior authorization predictability. Positive Sentiment: The company submitted an IDE for a large randomized controlled trial that management says could triple the TAM by expanding ejection fraction and NT‑ProBNP cutoffs; FDA feedback is expected in late November and, if agreed, CMS Category B IDE coverage would enable trial enrollment in H1 2026. Positive Sentiment: Gross profit rose to $12.8M with gross margin improving to 87% (from 83%) driven by higher ASPs and manufacturing efficiencies, and cash & equivalents of $85.1M provide runway to execute the plan. Negative Sentiment: Management raised full‑year operating expense guidance to $98–99M and interest expense increased from higher borrowings, while Q4 revenue guidance is modest, implying limited near‑term margin improvement despite top‑line momentum. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCVRx Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Greetings and welcome to the CVRx Third Quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Vallie, from ICR Healthcare. Thank you, sir. You may begin. Mike VallieManaging Director of Healthcare Investor Relations and Capital Markets Advisory at CVRx00:00:29Good afternoon. Thank you for joining us today for CVRx's Third Quarter 2025 Earnings Conference Call. Joining me on today's call are the company's President and Chief Executive Officer, Kevin Hykes, and Chief Financial Officer, Jared Oasheim. The remarks today will contain forward-looking statements, including statements about financial guidance. These statements are based on plans and expectations as of today, which may change over time. In addition, actual results could differ materially due to a number of risks and uncertainties, including those identified in the earnings release issued prior to this call and in the company's SEC filings. I would now like to turn the call over to CVRx's President and Chief Executive Officer, Kevin Hykes. Kevin HykesPresident and CEO at CVRx00:01:11Thanks, Mike. Good afternoon, everyone, and thank you for joining our third quarter earnings call. Q3 was a strong quarter for CVRx. We grew revenue by double digits year over year and expanded our commercial footprint. Our newer reps are hitting their stride, driving procedure volumes and building productive relationships with the physicians and APPs that manage heart failure patients in the community. Let me remind you of our three strategic priorities for 2025. Our first priority is building a world-class sales organization that develops sustainable Barostim programs with deep therapy adoption. Our sales force transformation is progressing well, and turnover is returning to more normal levels. The first wave of the sales reps hired earlier this year are getting up to speed and making meaningful contributions. Kevin HykesPresident and CEO at CVRx00:01:58We will continue hiring high-quality talent, but at a more measured pace that aligns with our territory expansion plans rather than the accelerated hiring that was needed to support the transformation. With this foundation in place, we're now concentrating on onboarding the new reps and accelerating their path to productivity. Second, we're targeting centers with the highest potential for sustainable programs and implementing a best practice playbook to drive deep therapy adoption. Our refined approach to account targeting guides our expansion strategy, focusing on high-potential Tier One and Tier Two accounts. That being said, we're also selectively pursuing pragmatic opportunities in Tier Three and Four accounts where we see committed physician champions, administrative support, and the right fundamentals. We added 10 net new centers this quarter and are seeing traction with this approach. Our top accounts are demonstrating the deepening adoption that is the hallmark of an established Barostim program. Kevin HykesPresident and CEO at CVRx00:02:57More than 20% of our active implanting centers achieved three or more implants in Q3, and our highest-performing sites are now implanting more than 10 patients per quarter. This demonstrates what is possible when committed physician champions and strong institutional support come together. Our third priority is addressing the primary barriers to the adoption of Barostim therapy by improving patient access, expanding therapy awareness, and building out our portfolio of clinical evidence. As it relates to patient access, we are making headway on multiple fronts. In July, CMS proposed maintaining Barostim in new technology APC 1580, with payment of approximately $45,000 for procedures performed in the outpatient setting. The second rule proposed in July and finalized on October 31 is our transition to a Category One CPT code effective January 1 of 2026. Kevin HykesPresident and CEO at CVRx00:03:53The Category One designation eliminates the experimental and investigational denials regularly seen with Category Three CPT codes, improves prior authorization predictability and throughput, and ensures that physicians are paid fairly and consistently for the procedure. On the coverage front, we are continuing to see encouraging trends and positive support from Medicare, Medicare Advantage, and commercial payers. Taken as a whole, these reimbursement advancements are creating an increasingly solid foundation for patient access and facilitate our work to move Barostim towards standard of care. Our awareness efforts are focused on educating clinicians on the appropriate role of Barostim therapy in the treatment of heart failure. We are engaging more deeply with the networks of referral physicians that surround our targeted centers through expanded national, regional, and local medical education programs. Kevin HykesPresident and CEO at CVRx00:04:44Beyond these physician-focused programs, we've continued to expand our engagement with advanced practice providers, or APPs, with a significant number of APP-specific educational programs completed year to date. These events are driving substantial interest and awareness in Barostim therapy among community-based APPs who manage most of our indicated heart failure patients on a day-to-day basis. During the quarter, we also had a significant presence at the Heart Failure Society of America meeting, one of the largest global heart failure conferences, where we hosted a multidisciplinary symposium with over 125 attendees. Our clinical evidence portfolio supporting Barostim therapy continues to grow, and we are seeing an increasing flow of independent peer-reviewed publications being submitted from our implanting centers and reporting positive patient outcomes. Kevin HykesPresident and CEO at CVRx00:05:37Recently, we've seen single-center studies showing significant improvements in Barostim patients, including a reduction in hospitalizations, reduced arrhythmia burden, and a positive impact on the ability to up-titrate and optimize guideline-directed medical therapy. Also, our discussions with FDA around a potential new randomized controlled trial are progressing positively. We submitted our IDE application in mid-October and expect to receive feedback from FDA in late November. If we can reach agreement with FDA on the IDE protocol, we will then approach CMS to apply for Category B IDE coverage, a second and necessary condition in order for us to move forward with the trial. We're pleased with our third-quarter performance. The momentum we're building reflects our investments in team development and go-to-market execution, with an increasingly broad and strong contribution across our account and territory base. Kevin HykesPresident and CEO at CVRx00:06:33In fact, in the third quarter, we had more sales reps contributing implants than in any quarter in the company's history. We're seeing the consistent methodical progress needed to establish Barostim as a standard of care for heart failure patients. Now, I'd like to turn the call over to Jared for a financial review. Jared OasheimCFO at CVRx00:06:51Thanks, Kevin. Let me walk through our third-quarter financial results. Revenue was $14.7 million for the three months ended September 30, 2025, an increase of $1.3 million, or 10%, over the three months ended September 30, 2024. Revenue generated in the U.S. was $13.5 million for the three months ended September 30, 2025, an increase of $1.2 million, or 10%, over the three months ended September 30, 2024. Revenue units in the U.S. totaled 420 and 394 for the three months ended September 30, 2025, and 2024, respectively. The increases were primarily driven by continued growth in the U.S. heart failure business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of September 30, 2025, the company had a total of 250 active implanting centers in the U.S., compared to 240 as of June 30, 2025. Jared OasheimCFO at CVRx00:07:55Active implanting centers are customers that have completed at least one commercial heart failure implant in the last 12 months. The number of sales territories in the US increased by three to a total of 50 during the three months ended September 30, 2025. Revenue generated in Europe was $1.2 million for the three months ended September 30, 2025, an increase of $0.1 million, or 12%, over the three months ended September 30, 2024. Total revenue units in Europe decreased to 50 for the three months ended September 30, 2025, compared to 56 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended September 30, 2025. Gross profit was $12.8 million for the three months ended September 30, 2025, an increase of $1.5 million, or 15%, over the three months ended September 30, 2024. Jared OasheimCFO at CVRx00:08:53Gross margin increased to 87% for the three months ended September 30, 2025, compared to 83% for the three months ended September 30, 2024. Gross margin for the three months ended September 30, 2025, was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies. R&D expenses increased $0.6 million, or 26%, to $3.1 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. This change was driven by a $0.5 million increase in compensation expenses and a $0.2 million increase in consulting expenses, partially offset by a $0.2 million decrease in clinical trial expenses. SG&A expenses increased $0.2 million, or 1%, to $21.9 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. Jared OasheimCFO at CVRx00:09:55This change was primarily driven by a $0.2 million increase in consulting expenses, a $0.2 million increase in travel expenses, and a $0.2 million increase in non-cash stock-based compensation expense, partially offset by a $0.2 million decrease in advertising expenses and a $0.2 million decrease in compensation expenses. Interest expense increased $0.5 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. This increase was driven by the interest expense on higher levels of borrowings under the term loan agreement with Innovatus Capital Partners. Other income net was $0.9 million for the three months ended September 30, 2024, and 2025. These balances consisted of interest income on our interest-bearing accounts. Jared OasheimCFO at CVRx00:10:46Net loss was $12.9 million, or $0.49 per share for the three months ended September 30, 2025, compared to a net loss of $13.1 million, or $0.57 per share for the three months ended September 30, 2024. Net loss per share was based on 26.2 million weighted average shares outstanding for the three months ended September 30, 2025, and 22.8 million weighted average shares outstanding for the three months ended September 30, 2024. As of September 30, 2025, cash and cash equivalents were $85.1 million. Net cash used in operating and investing activities was $10 million for the three months ended September 30, 2025, compared to $10.4 million for the three months ended September 30, 2024. Now, turning to guidance. For the full year of 2025, we now expect total revenue between $55.6 million and $56.6 million, compared to prior guidance of $55 million–$57 million. Jared OasheimCFO at CVRx00:11:48We now expect full-year gross margin between 85%–86%, compared to prior guidance of 83%–84%. We now expect operating expenses between $98 million-$99 million, compared to the prior guidance of $96 million–$98 million. For the fourth quarter of 2025, we expect to report total revenue between $15 million and $16 million. One additional note is that our existing registration statement is scheduled to expire on November 15th, 2025. As part of good corporate housekeeping, we plan to refresh our registration statement in connection with the filing of our Q3 10Q, which is expected to be filed tomorrow morning. With that, I'll now turn the call back over to Kevin for closing remarks. Kevin HykesPresident and CEO at CVRx00:12:36Thank you, Jared. Looking ahead, we now have the fundamentals in place to positively impact the lives of a meaningful number of heart failure patients and to create significant value in doing so. Our sales team is becoming more productive, and we're seeing positive signals from payers across the board. Our clinical evidence is expanding, and our awareness efforts are gaining traction. Financially, we're demonstrating improving operating leverage in our business model as we scale. Combined with our strong cash position, this gives us the resources and runway necessary to execute our strategy. Now, I'd like to open the line for questions. Operator? Operator00:13:15Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from John Young with Canaccord Genuity. Please proceed with your question. John YoungAnalyst at Canaccord Genuity00:13:53Hi, Kevin, Jared. Thanks for the hard question, and congratulations on the quarter. Maybe to start on the guidance, I appreciate the narrowed range, but perhaps you could walk us through why you cut the higher end, given that it sounds like reps are starting to hit their stride from your commentary. Are you expecting more of a benefit in 2026 than from their productivity? Is there anything you're seeing today in the business that's like that as well? Thank you. Jared OasheimCFO at CVRx00:14:19Hey, John. Happy to cover that one. Yeah, we were really happy with the results we saw in Q3. We're starting to see more of those new reps on the US side get up that productivity curve, but we know the work is not yet done in that arena, and we don't want to get too far ahead of ourselves. The performance that we saw in Q3, we saw that continue into October. That gives us the confidence and the guide that we set out by raising the midpoint of the old guidance that we had previously issued. John YoungAnalyst at Canaccord Genuity00:14:50Thank you. And then just on 2026, I'm not sure if you are willing to give any commentary yet, but it looks like the street's modeling about 18.5% growth in 2026. Are you comfortable with that level at this point? Jared OasheimCFO at CVRx00:15:04Yeah, it's a good question. We're coming off a year where the midpoint of the updated range will be a growth of about 10% compared to 2024. Having that as our baseline, we're still anticipating to continue to invest in this business where we're going to be adding more sales reps, activating more territories, and continuing to invest in the rest of the business. I think as we march into 2026, we're starting to target growth kind of in the mid-teens to see it accelerate from the growth rates we're seeing in 2025. Eventually getting back to those longer-term targets of seeing higher growth rates in the mid-20% range, but that's out in 2027 and beyond. John YoungAnalyst at Canaccord Genuity00:15:48Thanks so much, Jared. Operator00:15:54Our next question comes from Matt O'Brien with Piper Sandler. Please proceed with your question. Samantha MunozVP of MedTech Equity Research at Piper Sandler00:16:01Hi, this is Samantha on for Matt today. Thanks so much for taking our question and the good performance in the quarter. I also wanted to touch on the productivity improvements with the Salesforce. Could you give any more color or quantification? How many of the sales reps are kind of giving up to the productivity that you'd like to see? Would you say everyone's ramped? Just any more color there would be great. Kevin HykesPresident and CEO at CVRx00:16:26Yeah, thanks, Samantha. I'll take that as Kevin. I would say we're pleased with what we're seeing from the new reps, particularly those we've hired in the last three quarters. As Jared mentioned in his comments, I believe more reps today are active and contributing in the quarter than we've ever seen before. We're seeing them start to come up the curve and understand their roles and get comfortable in their territories and contribute. We're nowhere near yet seeing the full productivity that we would expect from these new hires. I think there's still some work to do there. As we've communicated in the past, depending on the background of the individual and the territory that they're assuming or building from scratch, it can take 6–9–12 months for them to really start to contribute. Kevin HykesPresident and CEO at CVRx00:17:09I would say at this point, we're really pleased with what we're seeing and no reason to think that we won't see continued improvement. Samantha MunozVP of MedTech Equity Research at Piper Sandler00:17:18That's perfect. Thanks. One more from us. It was great to see the Category One code finalized in the Physician Fee Schedule that was published just a few days ago. How should we be thinking about the reimbursement changes that are going to be implemented starting January 1? Kevin HykesPresident and CEO at CVRx00:17:35Sure. That's a great question. I would say overall, we're thrilled with the developments over the last year in reimbursement and what we see on the sort of horizon. We're seeing really strong support from the MACs for traditional Medicare, improving rates from the Medicare Advantage carriers, some really positive signals both at the prior auth level as well as at the kind of second and third level reviews and even at the administrative law judge level. Those are each different points during the appeals process where you challenge a payer to cover a case. We're seeing improving trends in all those areas. Obviously, Category One in January will be an important next step for us. That eliminates the payer's ability to automatically deny our prior authorizations on the basis of them being experimental. Kevin HykesPresident and CEO at CVRx00:18:24This means as of January One, each authorization has to be reviewed by a human clinician, and reason must be given for why it's being denied. I wouldn't characterize that as an immediate sort of step function change, but it will certainly, as it becomes more and more impactful as we enter the second and third quarter of the year, we will see the friction in the system reduced, and we believe it will result in higher rates of approval and shorter times to those approvals for prior authorizations. Samantha MunozVP of MedTech Equity Research at Piper Sandler00:18:56Great. Thank you. Operator00:19:01Our next question comes from Robbie Marcus with JPMorgan. Please proceed with your question. Operator00:19:06Hi. This is actually Rohan on for Robbie. Thanks so much for taking our question. I have a question on margins. Gross margin came in a decent clip ahead of expectations in the quarter, and I was just wondering if you could provide some further color on how much of this is due to better pricing versus some of the manufacturing efficiencies that you called out. Is this a new steady state that we should expect heading into 2026 just from a gross margin perspective? Jared OasheimCFO at CVRx00:19:33Yeah. Hi, Rohan. I think we tried to call it out in the earlier remarks. It is a mix. It is a bit of increased ASPs and an improvement in the cost per unit. ASPs for the quarter were north of $31,000 on a worldwide basis. That is a pretty good step up from what we saw Q3 last year, where it was just below $30,000 per unit across the whole globe for ASPs. I do think the bigger chunk that drove this improvement in Q3 margins was the cost per unit. We are continuing to build more and more units in our facility here in Minneapolis. As a result of that, we are seeing our labor and overhead cost spread over more units, seeing that cost come down. Jared OasheimCFO at CVRx00:20:21I think the ASP side of the house, we're not ready to just bake it in just yet longer term, but we do think there is promise that we could maintain these levels moving forward. On the cost side, we do think these are production levels that we're going to continue at or continue to increase upon. That should give us comfort to be able to keep these costs in a similar range moving forward. Jared OasheimCFO at CVRx00:20:44Great. Thanks. I guess I also wanted to clarify a prior point that you may have made. Just kind of heading into 2026, given the new Category One CPT code set to take effect and the favorable PFS rates and extension of the APC payment, it also seems like you have a better grasp on the commercial organization as you sit here today. Is it fair to say that all these kind of developments in conjunction should drive an acceleration in sales growth in 2026? Could you frame that, some of the puts and takes for investors, based on how you're thinking about it today? Jared OasheimCFO at CVRx00:21:19Yeah. That's a great kind of summary of what we have going into 2026. I think part of this is we're coming off a year from 2024–2025 where we went through a Salesforce transformation. We really implemented this go-to-market strategy that was brought forward at the end of 2024. We're starting to see some really nice results here in the third quarter and driving into the end of the year. I think as we're moving into 2026, we are expecting to see a re-acceleration of growth. As I mentioned earlier, kind of initially targeting the mid-teens for what we would expect for growth rates 2026 over 2025. There is potential for exceeding those expectations if everything lines up for us with the Category One taking effect, with payers moving in the right direction for prior auth approval rates and the time to those approvals. Jared OasheimCFO at CVRx00:22:11I think the base case for us at this point is seeing that re-acceleration go from about 10% to the mid-teens as we move into 2026. Jared OasheimCFO at CVRx00:22:20Great. Thank you. Operator00:22:24Our next question comes from Brandon Vazquez with William Blair. Please proceed with your question. Max O'BrienAnalyst at William Blair00:22:30Hey, guys. Max O'Brien for Brandon. Thanks for taking the question. Kevin, you mentioned you guys are focused on getting these newly hired reps up to speed more quickly. Can you just touch on how you guys are approaching that? What specifically you guys are doing that's giving you confidence that they will get up the productivity curve quicker? What's giving you confidence that newer reps that you hire will fall into the same playbook? I have a follow-up. Thanks. Kevin HykesPresident and CEO at CVRx00:22:54Sure. Great question. I would say it starts with the people that we're hiring. As we've talked about extensively over the last 18 months, we're really trying to develop a sales team that has program development, that has market development skills, that has sort of a process-driven mentality different than what you'd often find in an early-stage sort of startup environment or in a more mature industry where you're fighting for market share. These are people that know how to develop new programs and introduce new therapies. That's the raw material that goes into it. Kevin HykesPresident and CEO at CVRx00:23:26We've made significant investment in our sales training resources, both the curriculum and the experts that we've hired that train these reps and have instituted a much more deliberate and systematized sales training process that we believe compresses their time to comfort with our therapy and with their territories and with the process necessary to open a sustainable Barostim account. That differs by person, of course, but we're pleased with what we're seeing, and we're pleased, anecdotally at least today, to see some of these reps getting up to speed much faster than has historically been the case. It's probably a combination of all those things. It also comes with picking the right accounts, right? We think we know enough about this market today that we can be better at selecting where to spend our time too. Kevin HykesPresident and CEO at CVRx00:24:14Pick the right accounts that can get up to speed perhaps more quickly than in the past. It is a combination of factors, but we're pleased with what we're seeing. Max O'BrienAnalyst at William Blair00:24:23Got it. That's helpful. Kevin, just on the RCT, can you guys just touch on additional milestones, what might be left there following the next steps in November? Maybe just remind us all what you guys are going after there and what positive results in the future can mean for the TAM? Jared OasheimCFO at CVRx00:24:39Sure. That's a great question. As a reminder, we are in discussions. We've submitted an IDE for a very significant randomized controlled trial that would triple our TAM by both moving the EF, the ejection fraction cutoff, from 35%–50%, and also moving the cutoff for something called NT-ProBNP. That's a biomarker that describes the stability of heart failure that would move from its current level of 1,600 up to 5,000. The patients that are in that expanded range have a very similar disease and we believe will respond similarly to Barostim therapy. This represents a pretty compelling way to expand that indication to an adjacent group of patients who are very much today in the environments that our sales reps are calling on. That's the goal behind the trial. We have submitted the IDE, as I mentioned, to FDA. Jared OasheimCFO at CVRx00:25:34We hope to hear back from them sometime in November. If we can indeed reach agreement on a trial design, we would then go to CMS and submit for a Category B IDE coverage designation. That is a very necessary second step. That means that CMS will agree to pay for the patients who receive our device in this trial. With that second approval, if successful, we would begin center outreach and would anticipate treating the first patients in this trial sometime in the first half of 2026. Max O'BrienAnalyst at William Blair00:26:07That's great. Thanks for taking the question, guys. Jared OasheimCFO at CVRx00:26:09Sure. Operator00:26:12Our next question comes from Frank Takkinen with Lake Street Capital Markets. Please proceed with your question. Frank TakkinenSenior Research Analyst at Lake Street Capital Markets00:26:20Great. Thanks for taking the questions. I'm going to pick up on the RCT, so a little deeper there. Kevin, maybe talk to how many patients you're thinking will be enrolled in this trial. And then on the Category B, do you think you can get a reimbursement rate similar to the ASP that you're currently collecting? Kevin HykesPresident and CEO at CVRx00:26:37Sure. Thanks, Frank. As I think maybe we'd mentioned on a prior call, we're seeing this trial at roughly around 2,000 patients randomized to either Barostim therapy or guideline-directed medical care. That would make it one of the largest cardiovascular device trials ever conducted. This would be seen as a significant sort of scientific contribution to the field. It would likely involve 100+ centers given the assumed enrollment rates by center. It would likely take us about four years to enroll this trial with another 18 months to two years of follow-up after that point. It would be a significant trial, a significant investment. We believe there's a good likelihood that CMS will, in fact, cover this under a Category B IDE designation. Kevin HykesPresident and CEO at CVRx00:27:26The criteria for that designation are clear and are not subjective, and we've designed the trial in a manner that we think would meet those criteria. As it relates to ASPs, I'll let Jared speak to that. Jared OasheimCFO at CVRx00:27:39Yeah. Happy to jump in on that piece, Frank. Our expectation is that CMS would reimburse the hospitals the exact same rate that they're reimbursing them today in the outpatient setting. If they're being reimbursed $45,000 today under the new tech APC 1580, they'd get a similar reimbursement if these patients are enrolled through the clinical trial. Frank TakkinenSenior Research Analyst at Lake Street Capital Markets00:28:02Got it. That's great. Thanks. I think, Kevin, I heard you speak to the concept of Salesforce is stable now and still intending to grow that Salesforce. You've been in the range of three new sales territories per quarter. Is that the right way to think about it in 2026? Kevin HykesPresident and CEO at CVRx00:28:20Yeah, I think it is. Thank you. I think at this point, we're pleased with what we're seeing, but we're still working the kinks out of our system, and we think that's probably the right number of new territories per quarter to model going forward. We're hopeful eventually that may increase, but for now, that's the right spot to start. Frank TakkinenSenior Research Analyst at Lake Street Capital Markets00:28:38Okay. Perfect. Thanks for taking the questions. Operator00:28:43Our next question comes from Chase Knickerbocker with Craig-Hallum Capital Group. Please proceed with your question. Chase KnickerbockerSenior Research Analyst at Craig–Hallum Capital Group00:28:51Good afternoon. Thanks for taking the questions. I just wanted to dig in a little bit more on the guide as well. Q4 implies essentially flat year-over-year growth and less sequential growth relative to the past six or seven quarters. I guess, what are you seeing so far in the quarter through October that's the driver here? I'm just kind of having trouble squaring the commentary that some of the reps are getting up to speed faster than expected. I would think with many of your reps now getting to that productive kind of six-plus months in their territory point. I'm just kind of having trouble squaring that. Is there conservatism in that guide? I mean, maybe just kind of speak to the moving pieces. Jared OasheimCFO at CVRx00:29:32Yeah. Good question, Chase. I mean, as comparing year-over-year, I think we've talked about this the last few quarters. We had a bit of a reset with our top-line numbers back in Q1. We've been working to grow that number sequentially after that Salesforce transformation took place. We've been seeing that sequential growth rate in the range of 8-10%. I think if I look at the guide that's out here for worldwide numbers for Q4, the midpoint would get us to about 6% sequential growth. A little bit of a step back. I think what we're seeing is more reps are getting up the productivity curve, more territories are becoming active. Again, we just want to make sure that we're kind of through the thick of it here before we would get much more aggressive with the numbers coming out. Jared OasheimCFO at CVRx00:30:18I think even at the midpoint, we're talking growth north of $1 million sequentially from Q3 to Q4. Chase KnickerbockerSenior Research Analyst at Craig–Hallum Capital Group00:30:29Can you maybe speak to kind of how rep tenure has progressed? Any kind of update to any of the turnover metrics, et cetera, just kind of health of the Salesforce update? Jared OasheimCFO at CVRx00:30:44Yeah. I think we last gave updates a couple of months ago on the percentage of reps that were hired in 2024, 2025. We have not seen significant changes there. I think Kevin alluded to this in his prepared remarks that we are back to hiring per normal levels. We are not out there accelerating our hiring to backfill a bunch of reps that were turned over. At this stage, we have not seen significant movement in those percentages of reps that were hired in 2024 and 2025. Chase KnickerbockerSenior Research Analyst at Craig–Hallum Capital Group00:31:18Just last. Jared OasheimCFO at CVRx00:31:19Just to close it out, I mean, overall turnover, kind of returning back to those normal levels. I think we've alluded to it in the past. Annual turnover levels that we think to be normal are kind of in that range of 10–20%. Chase KnickerbockerSenior Research Analyst at Craig–Hallum Capital Group00:31:35Got it. Just maybe on the OPPS, any sort of engagement around Level Six Neurostimulator Code outside of the comments you submitted? Second, Jared, just appreciate those thoughts for 2026. I mean, maybe just also some thoughts on expenses next year, just kind of how you plan to manage the business from an OpEx perspective as we look at 2026. Jared OasheimCFO at CVRx00:32:03Yep. On the OPPS side, I think everybody's sitting and waiting for when that final rule will post. Just a reminder for everybody that CMS did come out this year in the proposed rule back in July that we would be mapped to the new tech APC 1580 for 2026. We don't expect that to change in the final rule, but there is still a chance for some upside where they could create a Level Six Neurostim Code. We're still waiting for that final rule, which we understand could be published any day now. We'll come back and give updates on that as information becomes available. There's no additional information behind the scenes. It's all of us just waiting for CMS to release this rule. On 2026 spend, we do anticipate that we're going to continue to see leverage in this model. Jared OasheimCFO at CVRx00:32:49If we're modeling mid-teens top-line growth with slight improvements on margins, we're not intending all of that gross profit to be spent within operating expenses. We would expect the OPEX growth to be at a lower rate than what we're modeling for top line. Again, we'll come out with more detail on that when we finalize guidance for 2026. Operator00:33:24Our final question comes from Ross Osborne with Cantor Fitzgerald. Please proceed with your question. Ross OsborneDirector and Lead Research Analyst at Fitzgerald00:33:30Hey, guys. Congrats on the progress, and thanks for taking our questions. Maybe just a quick modeling question from us. Your 2025 OpEx guide implies a sequential step down. Is that fair to assume the savings will come from the R&D line sequentially? Jared OasheimCFO at CVRx00:33:46Yeah, it's a good question, Ross. So actually, I think we expect that. Movement would likely happen within SG&A sequentially from Q3–Q4. Q4 is typically a lighter order when it comes to trade show and marketing spend. And so we would typically see a little or fewer dollars going into that bucket in the fourth quarter as compared to the third. Ross OsborneDirector and Lead Research Analyst at Fitzgerald00:34:10Okay. Got it. Then looking at your top accounts doing three or more implants and the highest at greater than 10, are there any structural differences between those averaging three versus 10, or do you think those currently averaging three have the ability to ramp to 10 over time? Kevin HykesPresident and CEO at CVRx00:34:27That's a great question. I'll take that. Thanks, Ross. I would say it's the latter. There are no structural differences there. We think this is ultimately the effect of us sort of steadily improving the mix of accounts that we have and their likelihood of deep adoption and the tools that we're applying to them, this methodical process of getting the right stakeholders in place, getting administrative support in place, and building a robust and resilient network in these accounts that allows them to build this into how they treat the disease. We're pleased with what we're seeing. No reason to believe that they couldn't all be operating at that level. In fact, that's our goal. Ross OsborneDirector and Lead Research Analyst at Fitzgerald00:35:06Great. Thanks for taking our questions. Operator00:35:11We've reached the end of our question and answer session. I would now like to turn the floor back over to Kevin Hykes for closing comments. Kevin HykesPresident and CEO at CVRx00:35:17Thank you, Operator. And thanks to everyone for joining today. We appreciate your continued support and look forward to updating you on our progress next quarter. Thank you. Operator00:35:28This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read moreParticipantsExecutivesMike VallieManaging Director of Healthcare Investor Relations and Capital Markets AdvisoryKevin HykesPresident and CEOJared OasheimCFOAnalystsFrank TakkinenSenior Research Analyst at Lake Street Capital MarketsRoss OsborneDirector and Lead Research Analyst at FitzgeraldAnalyst at JPMorganMax O'BrienAnalyst at William BlairChase KnickerbockerSenior Research Analyst at Craig–Hallum Capital GroupSamantha MunozVP of MedTech Equity Research at Piper SandlerJohn YoungAnalyst at Canaccord GenuityPowered by Earnings DocumentsEarnings Release(8-K)Quarterly Report(10-Q) CVRx Earnings HeadlinesCVRx to Present at the William Blair 46th Annual Growth Stock ConferenceMay 20, 2026 | globenewswire.comCVRx (NASDAQ:CVRX) Upgraded to Hold at Wall Street ZenMay 16, 2026 | americanbankingnews.comNobody Understands Why Trump Is Invading Iran (here’s the answer)Most investors are reacting to the Iran strikes without understanding the underlying motive driving the decision. Addison Wiggin, Founder of Grey Swan Investment Fraternity, says there is a hidden reason behind the bombing - and knowing it could change how you position your money right now.May 25 at 1:00 AM | Banyan Hill Publishing (Ad)Analysts Have Made A Financial Statement On CVRx, Inc.'s (NASDAQ:CVRX) First-Quarter ReportMay 15, 2026 | finance.yahoo.comCVRx rebounds as Humana issues Medicare policy for BarostimMay 14, 2026 | msn.comCVRx Announces Humana Medicare Advantage Coverage Policy for Barostim TherapyMay 14, 2026 | globenewswire.comSee More CVRx Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like CVRx? Sign up for Earnings360's daily newsletter to receive timely earnings updates on CVRx and other key companies, straight to your email. Email Address About CVRxCVRx (NASDAQ:CVRX) is a clinical-stage medical device company focused on developing a neuromodulation platform therapy for patients with cardiovascular disease. The company’s flagship product, the Barostim™ system, delivers targeted electrical stimulation to the carotid baroreceptors with the goal of modulating the body’s natural blood pressure control mechanisms. This minimally invasive, implantable therapy is designed to address unmet needs in individuals suffering from hypertension and heart failure. The Barostim system is currently being evaluated in multiple clinical trials, including studies in resistant hypertension and advanced heart failure. CVRx has achieved regulatory milestones in key regions, having secured CE mark approval in Europe for both hypertension and heart failure indications. In parallel, the company is actively working with the U.S. Food and Drug Administration to advance its therapy through pivotal clinical data collection under the BeAT-HF (Barostim Therapy for Heart Failure) trial. Founded in 2006 as a spin-out of Medtronic’s neuromodulation research program, CVRx established its headquarters in Minneapolis, Minnesota. Since its inception, the company has conducted international feasibility and pivotal studies, collaborating with leading cardiovascular centers in Europe, North America and Asia. CVRx began trading publicly on the NASDAQ under the ticker “CVRX” in 2018, positioning itself to leverage global partnerships and expand patient access to its technology. CVRx is led by an executive team with deep expertise in medical device development, clinical research and regulatory strategy. The organization maintains commercial and clinical infrastructure across multiple geographies, with a focus on building physician and patient awareness of baroreflex activation therapy. Through ongoing innovation and evidence generation, CVRx aims to establish neuromodulation as a durable treatment option for cardiovascular patients worldwide.View CVRx ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Ross Stores Earnings Beat Sends Stock To New HighsWas Decker’s Double Beat a Bullish Signal—Or Mere HOKA’s-Pocus?Workday Validates AI Flywheel: Stock Price Recovery BeginsApparel Earnings Winners and Losers: Ralph Lauren Takes OffWhy Walmart, Target and TJX Got Such Different Reactions After EarningsThe Careful Consumer: What Q1 Earnings Reveal—And Where Cracks May AppearOverextended, e.l.f. 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PresentationSkip to Participants Operator00:00:00Greetings and welcome to the CVRx Third Quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Vallie, from ICR Healthcare. Thank you, sir. You may begin. Mike VallieManaging Director of Healthcare Investor Relations and Capital Markets Advisory at CVRx00:00:29Good afternoon. Thank you for joining us today for CVRx's Third Quarter 2025 Earnings Conference Call. Joining me on today's call are the company's President and Chief Executive Officer, Kevin Hykes, and Chief Financial Officer, Jared Oasheim. The remarks today will contain forward-looking statements, including statements about financial guidance. These statements are based on plans and expectations as of today, which may change over time. In addition, actual results could differ materially due to a number of risks and uncertainties, including those identified in the earnings release issued prior to this call and in the company's SEC filings. I would now like to turn the call over to CVRx's President and Chief Executive Officer, Kevin Hykes. Kevin HykesPresident and CEO at CVRx00:01:11Thanks, Mike. Good afternoon, everyone, and thank you for joining our third quarter earnings call. Q3 was a strong quarter for CVRx. We grew revenue by double digits year over year and expanded our commercial footprint. Our newer reps are hitting their stride, driving procedure volumes and building productive relationships with the physicians and APPs that manage heart failure patients in the community. Let me remind you of our three strategic priorities for 2025. Our first priority is building a world-class sales organization that develops sustainable Barostim programs with deep therapy adoption. Our sales force transformation is progressing well, and turnover is returning to more normal levels. The first wave of the sales reps hired earlier this year are getting up to speed and making meaningful contributions. Kevin HykesPresident and CEO at CVRx00:01:58We will continue hiring high-quality talent, but at a more measured pace that aligns with our territory expansion plans rather than the accelerated hiring that was needed to support the transformation. With this foundation in place, we're now concentrating on onboarding the new reps and accelerating their path to productivity. Second, we're targeting centers with the highest potential for sustainable programs and implementing a best practice playbook to drive deep therapy adoption. Our refined approach to account targeting guides our expansion strategy, focusing on high-potential Tier One and Tier Two accounts. That being said, we're also selectively pursuing pragmatic opportunities in Tier Three and Four accounts where we see committed physician champions, administrative support, and the right fundamentals. We added 10 net new centers this quarter and are seeing traction with this approach. Our top accounts are demonstrating the deepening adoption that is the hallmark of an established Barostim program. Kevin HykesPresident and CEO at CVRx00:02:57More than 20% of our active implanting centers achieved three or more implants in Q3, and our highest-performing sites are now implanting more than 10 patients per quarter. This demonstrates what is possible when committed physician champions and strong institutional support come together. Our third priority is addressing the primary barriers to the adoption of Barostim therapy by improving patient access, expanding therapy awareness, and building out our portfolio of clinical evidence. As it relates to patient access, we are making headway on multiple fronts. In July, CMS proposed maintaining Barostim in new technology APC 1580, with payment of approximately $45,000 for procedures performed in the outpatient setting. The second rule proposed in July and finalized on October 31 is our transition to a Category One CPT code effective January 1 of 2026. Kevin HykesPresident and CEO at CVRx00:03:53The Category One designation eliminates the experimental and investigational denials regularly seen with Category Three CPT codes, improves prior authorization predictability and throughput, and ensures that physicians are paid fairly and consistently for the procedure. On the coverage front, we are continuing to see encouraging trends and positive support from Medicare, Medicare Advantage, and commercial payers. Taken as a whole, these reimbursement advancements are creating an increasingly solid foundation for patient access and facilitate our work to move Barostim towards standard of care. Our awareness efforts are focused on educating clinicians on the appropriate role of Barostim therapy in the treatment of heart failure. We are engaging more deeply with the networks of referral physicians that surround our targeted centers through expanded national, regional, and local medical education programs. Kevin HykesPresident and CEO at CVRx00:04:44Beyond these physician-focused programs, we've continued to expand our engagement with advanced practice providers, or APPs, with a significant number of APP-specific educational programs completed year to date. These events are driving substantial interest and awareness in Barostim therapy among community-based APPs who manage most of our indicated heart failure patients on a day-to-day basis. During the quarter, we also had a significant presence at the Heart Failure Society of America meeting, one of the largest global heart failure conferences, where we hosted a multidisciplinary symposium with over 125 attendees. Our clinical evidence portfolio supporting Barostim therapy continues to grow, and we are seeing an increasing flow of independent peer-reviewed publications being submitted from our implanting centers and reporting positive patient outcomes. Kevin HykesPresident and CEO at CVRx00:05:37Recently, we've seen single-center studies showing significant improvements in Barostim patients, including a reduction in hospitalizations, reduced arrhythmia burden, and a positive impact on the ability to up-titrate and optimize guideline-directed medical therapy. Also, our discussions with FDA around a potential new randomized controlled trial are progressing positively. We submitted our IDE application in mid-October and expect to receive feedback from FDA in late November. If we can reach agreement with FDA on the IDE protocol, we will then approach CMS to apply for Category B IDE coverage, a second and necessary condition in order for us to move forward with the trial. We're pleased with our third-quarter performance. The momentum we're building reflects our investments in team development and go-to-market execution, with an increasingly broad and strong contribution across our account and territory base. Kevin HykesPresident and CEO at CVRx00:06:33In fact, in the third quarter, we had more sales reps contributing implants than in any quarter in the company's history. We're seeing the consistent methodical progress needed to establish Barostim as a standard of care for heart failure patients. Now, I'd like to turn the call over to Jared for a financial review. Jared OasheimCFO at CVRx00:06:51Thanks, Kevin. Let me walk through our third-quarter financial results. Revenue was $14.7 million for the three months ended September 30, 2025, an increase of $1.3 million, or 10%, over the three months ended September 30, 2024. Revenue generated in the U.S. was $13.5 million for the three months ended September 30, 2025, an increase of $1.2 million, or 10%, over the three months ended September 30, 2024. Revenue units in the U.S. totaled 420 and 394 for the three months ended September 30, 2025, and 2024, respectively. The increases were primarily driven by continued growth in the U.S. heart failure business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of September 30, 2025, the company had a total of 250 active implanting centers in the U.S., compared to 240 as of June 30, 2025. Jared OasheimCFO at CVRx00:07:55Active implanting centers are customers that have completed at least one commercial heart failure implant in the last 12 months. The number of sales territories in the US increased by three to a total of 50 during the three months ended September 30, 2025. Revenue generated in Europe was $1.2 million for the three months ended September 30, 2025, an increase of $0.1 million, or 12%, over the three months ended September 30, 2024. Total revenue units in Europe decreased to 50 for the three months ended September 30, 2025, compared to 56 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended September 30, 2025. Gross profit was $12.8 million for the three months ended September 30, 2025, an increase of $1.5 million, or 15%, over the three months ended September 30, 2024. Jared OasheimCFO at CVRx00:08:53Gross margin increased to 87% for the three months ended September 30, 2025, compared to 83% for the three months ended September 30, 2024. Gross margin for the three months ended September 30, 2025, was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies. R&D expenses increased $0.6 million, or 26%, to $3.1 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. This change was driven by a $0.5 million increase in compensation expenses and a $0.2 million increase in consulting expenses, partially offset by a $0.2 million decrease in clinical trial expenses. SG&A expenses increased $0.2 million, or 1%, to $21.9 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. Jared OasheimCFO at CVRx00:09:55This change was primarily driven by a $0.2 million increase in consulting expenses, a $0.2 million increase in travel expenses, and a $0.2 million increase in non-cash stock-based compensation expense, partially offset by a $0.2 million decrease in advertising expenses and a $0.2 million decrease in compensation expenses. Interest expense increased $0.5 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. This increase was driven by the interest expense on higher levels of borrowings under the term loan agreement with Innovatus Capital Partners. Other income net was $0.9 million for the three months ended September 30, 2024, and 2025. These balances consisted of interest income on our interest-bearing accounts. Jared OasheimCFO at CVRx00:10:46Net loss was $12.9 million, or $0.49 per share for the three months ended September 30, 2025, compared to a net loss of $13.1 million, or $0.57 per share for the three months ended September 30, 2024. Net loss per share was based on 26.2 million weighted average shares outstanding for the three months ended September 30, 2025, and 22.8 million weighted average shares outstanding for the three months ended September 30, 2024. As of September 30, 2025, cash and cash equivalents were $85.1 million. Net cash used in operating and investing activities was $10 million for the three months ended September 30, 2025, compared to $10.4 million for the three months ended September 30, 2024. Now, turning to guidance. For the full year of 2025, we now expect total revenue between $55.6 million and $56.6 million, compared to prior guidance of $55 million–$57 million. Jared OasheimCFO at CVRx00:11:48We now expect full-year gross margin between 85%–86%, compared to prior guidance of 83%–84%. We now expect operating expenses between $98 million-$99 million, compared to the prior guidance of $96 million–$98 million. For the fourth quarter of 2025, we expect to report total revenue between $15 million and $16 million. One additional note is that our existing registration statement is scheduled to expire on November 15th, 2025. As part of good corporate housekeeping, we plan to refresh our registration statement in connection with the filing of our Q3 10Q, which is expected to be filed tomorrow morning. With that, I'll now turn the call back over to Kevin for closing remarks. Kevin HykesPresident and CEO at CVRx00:12:36Thank you, Jared. Looking ahead, we now have the fundamentals in place to positively impact the lives of a meaningful number of heart failure patients and to create significant value in doing so. Our sales team is becoming more productive, and we're seeing positive signals from payers across the board. Our clinical evidence is expanding, and our awareness efforts are gaining traction. Financially, we're demonstrating improving operating leverage in our business model as we scale. Combined with our strong cash position, this gives us the resources and runway necessary to execute our strategy. Now, I'd like to open the line for questions. Operator? Operator00:13:15Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from John Young with Canaccord Genuity. Please proceed with your question. John YoungAnalyst at Canaccord Genuity00:13:53Hi, Kevin, Jared. Thanks for the hard question, and congratulations on the quarter. Maybe to start on the guidance, I appreciate the narrowed range, but perhaps you could walk us through why you cut the higher end, given that it sounds like reps are starting to hit their stride from your commentary. Are you expecting more of a benefit in 2026 than from their productivity? Is there anything you're seeing today in the business that's like that as well? Thank you. Jared OasheimCFO at CVRx00:14:19Hey, John. Happy to cover that one. Yeah, we were really happy with the results we saw in Q3. We're starting to see more of those new reps on the US side get up that productivity curve, but we know the work is not yet done in that arena, and we don't want to get too far ahead of ourselves. The performance that we saw in Q3, we saw that continue into October. That gives us the confidence and the guide that we set out by raising the midpoint of the old guidance that we had previously issued. John YoungAnalyst at Canaccord Genuity00:14:50Thank you. And then just on 2026, I'm not sure if you are willing to give any commentary yet, but it looks like the street's modeling about 18.5% growth in 2026. Are you comfortable with that level at this point? Jared OasheimCFO at CVRx00:15:04Yeah, it's a good question. We're coming off a year where the midpoint of the updated range will be a growth of about 10% compared to 2024. Having that as our baseline, we're still anticipating to continue to invest in this business where we're going to be adding more sales reps, activating more territories, and continuing to invest in the rest of the business. I think as we march into 2026, we're starting to target growth kind of in the mid-teens to see it accelerate from the growth rates we're seeing in 2025. Eventually getting back to those longer-term targets of seeing higher growth rates in the mid-20% range, but that's out in 2027 and beyond. John YoungAnalyst at Canaccord Genuity00:15:48Thanks so much, Jared. Operator00:15:54Our next question comes from Matt O'Brien with Piper Sandler. Please proceed with your question. Samantha MunozVP of MedTech Equity Research at Piper Sandler00:16:01Hi, this is Samantha on for Matt today. Thanks so much for taking our question and the good performance in the quarter. I also wanted to touch on the productivity improvements with the Salesforce. Could you give any more color or quantification? How many of the sales reps are kind of giving up to the productivity that you'd like to see? Would you say everyone's ramped? Just any more color there would be great. Kevin HykesPresident and CEO at CVRx00:16:26Yeah, thanks, Samantha. I'll take that as Kevin. I would say we're pleased with what we're seeing from the new reps, particularly those we've hired in the last three quarters. As Jared mentioned in his comments, I believe more reps today are active and contributing in the quarter than we've ever seen before. We're seeing them start to come up the curve and understand their roles and get comfortable in their territories and contribute. We're nowhere near yet seeing the full productivity that we would expect from these new hires. I think there's still some work to do there. As we've communicated in the past, depending on the background of the individual and the territory that they're assuming or building from scratch, it can take 6–9–12 months for them to really start to contribute. Kevin HykesPresident and CEO at CVRx00:17:09I would say at this point, we're really pleased with what we're seeing and no reason to think that we won't see continued improvement. Samantha MunozVP of MedTech Equity Research at Piper Sandler00:17:18That's perfect. Thanks. One more from us. It was great to see the Category One code finalized in the Physician Fee Schedule that was published just a few days ago. How should we be thinking about the reimbursement changes that are going to be implemented starting January 1? Kevin HykesPresident and CEO at CVRx00:17:35Sure. That's a great question. I would say overall, we're thrilled with the developments over the last year in reimbursement and what we see on the sort of horizon. We're seeing really strong support from the MACs for traditional Medicare, improving rates from the Medicare Advantage carriers, some really positive signals both at the prior auth level as well as at the kind of second and third level reviews and even at the administrative law judge level. Those are each different points during the appeals process where you challenge a payer to cover a case. We're seeing improving trends in all those areas. Obviously, Category One in January will be an important next step for us. That eliminates the payer's ability to automatically deny our prior authorizations on the basis of them being experimental. Kevin HykesPresident and CEO at CVRx00:18:24This means as of January One, each authorization has to be reviewed by a human clinician, and reason must be given for why it's being denied. I wouldn't characterize that as an immediate sort of step function change, but it will certainly, as it becomes more and more impactful as we enter the second and third quarter of the year, we will see the friction in the system reduced, and we believe it will result in higher rates of approval and shorter times to those approvals for prior authorizations. Samantha MunozVP of MedTech Equity Research at Piper Sandler00:18:56Great. Thank you. Operator00:19:01Our next question comes from Robbie Marcus with JPMorgan. Please proceed with your question. Operator00:19:06Hi. This is actually Rohan on for Robbie. Thanks so much for taking our question. I have a question on margins. Gross margin came in a decent clip ahead of expectations in the quarter, and I was just wondering if you could provide some further color on how much of this is due to better pricing versus some of the manufacturing efficiencies that you called out. Is this a new steady state that we should expect heading into 2026 just from a gross margin perspective? Jared OasheimCFO at CVRx00:19:33Yeah. Hi, Rohan. I think we tried to call it out in the earlier remarks. It is a mix. It is a bit of increased ASPs and an improvement in the cost per unit. ASPs for the quarter were north of $31,000 on a worldwide basis. That is a pretty good step up from what we saw Q3 last year, where it was just below $30,000 per unit across the whole globe for ASPs. I do think the bigger chunk that drove this improvement in Q3 margins was the cost per unit. We are continuing to build more and more units in our facility here in Minneapolis. As a result of that, we are seeing our labor and overhead cost spread over more units, seeing that cost come down. Jared OasheimCFO at CVRx00:20:21I think the ASP side of the house, we're not ready to just bake it in just yet longer term, but we do think there is promise that we could maintain these levels moving forward. On the cost side, we do think these are production levels that we're going to continue at or continue to increase upon. That should give us comfort to be able to keep these costs in a similar range moving forward. Jared OasheimCFO at CVRx00:20:44Great. Thanks. I guess I also wanted to clarify a prior point that you may have made. Just kind of heading into 2026, given the new Category One CPT code set to take effect and the favorable PFS rates and extension of the APC payment, it also seems like you have a better grasp on the commercial organization as you sit here today. Is it fair to say that all these kind of developments in conjunction should drive an acceleration in sales growth in 2026? Could you frame that, some of the puts and takes for investors, based on how you're thinking about it today? Jared OasheimCFO at CVRx00:21:19Yeah. That's a great kind of summary of what we have going into 2026. I think part of this is we're coming off a year from 2024–2025 where we went through a Salesforce transformation. We really implemented this go-to-market strategy that was brought forward at the end of 2024. We're starting to see some really nice results here in the third quarter and driving into the end of the year. I think as we're moving into 2026, we are expecting to see a re-acceleration of growth. As I mentioned earlier, kind of initially targeting the mid-teens for what we would expect for growth rates 2026 over 2025. There is potential for exceeding those expectations if everything lines up for us with the Category One taking effect, with payers moving in the right direction for prior auth approval rates and the time to those approvals. Jared OasheimCFO at CVRx00:22:11I think the base case for us at this point is seeing that re-acceleration go from about 10% to the mid-teens as we move into 2026. Jared OasheimCFO at CVRx00:22:20Great. Thank you. Operator00:22:24Our next question comes from Brandon Vazquez with William Blair. Please proceed with your question. Max O'BrienAnalyst at William Blair00:22:30Hey, guys. Max O'Brien for Brandon. Thanks for taking the question. Kevin, you mentioned you guys are focused on getting these newly hired reps up to speed more quickly. Can you just touch on how you guys are approaching that? What specifically you guys are doing that's giving you confidence that they will get up the productivity curve quicker? What's giving you confidence that newer reps that you hire will fall into the same playbook? I have a follow-up. Thanks. Kevin HykesPresident and CEO at CVRx00:22:54Sure. Great question. I would say it starts with the people that we're hiring. As we've talked about extensively over the last 18 months, we're really trying to develop a sales team that has program development, that has market development skills, that has sort of a process-driven mentality different than what you'd often find in an early-stage sort of startup environment or in a more mature industry where you're fighting for market share. These are people that know how to develop new programs and introduce new therapies. That's the raw material that goes into it. Kevin HykesPresident and CEO at CVRx00:23:26We've made significant investment in our sales training resources, both the curriculum and the experts that we've hired that train these reps and have instituted a much more deliberate and systematized sales training process that we believe compresses their time to comfort with our therapy and with their territories and with the process necessary to open a sustainable Barostim account. That differs by person, of course, but we're pleased with what we're seeing, and we're pleased, anecdotally at least today, to see some of these reps getting up to speed much faster than has historically been the case. It's probably a combination of all those things. It also comes with picking the right accounts, right? We think we know enough about this market today that we can be better at selecting where to spend our time too. Kevin HykesPresident and CEO at CVRx00:24:14Pick the right accounts that can get up to speed perhaps more quickly than in the past. It is a combination of factors, but we're pleased with what we're seeing. Max O'BrienAnalyst at William Blair00:24:23Got it. That's helpful. Kevin, just on the RCT, can you guys just touch on additional milestones, what might be left there following the next steps in November? Maybe just remind us all what you guys are going after there and what positive results in the future can mean for the TAM? Jared OasheimCFO at CVRx00:24:39Sure. That's a great question. As a reminder, we are in discussions. We've submitted an IDE for a very significant randomized controlled trial that would triple our TAM by both moving the EF, the ejection fraction cutoff, from 35%–50%, and also moving the cutoff for something called NT-ProBNP. That's a biomarker that describes the stability of heart failure that would move from its current level of 1,600 up to 5,000. The patients that are in that expanded range have a very similar disease and we believe will respond similarly to Barostim therapy. This represents a pretty compelling way to expand that indication to an adjacent group of patients who are very much today in the environments that our sales reps are calling on. That's the goal behind the trial. We have submitted the IDE, as I mentioned, to FDA. Jared OasheimCFO at CVRx00:25:34We hope to hear back from them sometime in November. If we can indeed reach agreement on a trial design, we would then go to CMS and submit for a Category B IDE coverage designation. That is a very necessary second step. That means that CMS will agree to pay for the patients who receive our device in this trial. With that second approval, if successful, we would begin center outreach and would anticipate treating the first patients in this trial sometime in the first half of 2026. Max O'BrienAnalyst at William Blair00:26:07That's great. Thanks for taking the question, guys. Jared OasheimCFO at CVRx00:26:09Sure. Operator00:26:12Our next question comes from Frank Takkinen with Lake Street Capital Markets. Please proceed with your question. Frank TakkinenSenior Research Analyst at Lake Street Capital Markets00:26:20Great. Thanks for taking the questions. I'm going to pick up on the RCT, so a little deeper there. Kevin, maybe talk to how many patients you're thinking will be enrolled in this trial. And then on the Category B, do you think you can get a reimbursement rate similar to the ASP that you're currently collecting? Kevin HykesPresident and CEO at CVRx00:26:37Sure. Thanks, Frank. As I think maybe we'd mentioned on a prior call, we're seeing this trial at roughly around 2,000 patients randomized to either Barostim therapy or guideline-directed medical care. That would make it one of the largest cardiovascular device trials ever conducted. This would be seen as a significant sort of scientific contribution to the field. It would likely involve 100+ centers given the assumed enrollment rates by center. It would likely take us about four years to enroll this trial with another 18 months to two years of follow-up after that point. It would be a significant trial, a significant investment. We believe there's a good likelihood that CMS will, in fact, cover this under a Category B IDE designation. Kevin HykesPresident and CEO at CVRx00:27:26The criteria for that designation are clear and are not subjective, and we've designed the trial in a manner that we think would meet those criteria. As it relates to ASPs, I'll let Jared speak to that. Jared OasheimCFO at CVRx00:27:39Yeah. Happy to jump in on that piece, Frank. Our expectation is that CMS would reimburse the hospitals the exact same rate that they're reimbursing them today in the outpatient setting. If they're being reimbursed $45,000 today under the new tech APC 1580, they'd get a similar reimbursement if these patients are enrolled through the clinical trial. Frank TakkinenSenior Research Analyst at Lake Street Capital Markets00:28:02Got it. That's great. Thanks. I think, Kevin, I heard you speak to the concept of Salesforce is stable now and still intending to grow that Salesforce. You've been in the range of three new sales territories per quarter. Is that the right way to think about it in 2026? Kevin HykesPresident and CEO at CVRx00:28:20Yeah, I think it is. Thank you. I think at this point, we're pleased with what we're seeing, but we're still working the kinks out of our system, and we think that's probably the right number of new territories per quarter to model going forward. We're hopeful eventually that may increase, but for now, that's the right spot to start. Frank TakkinenSenior Research Analyst at Lake Street Capital Markets00:28:38Okay. Perfect. Thanks for taking the questions. Operator00:28:43Our next question comes from Chase Knickerbocker with Craig-Hallum Capital Group. Please proceed with your question. Chase KnickerbockerSenior Research Analyst at Craig–Hallum Capital Group00:28:51Good afternoon. Thanks for taking the questions. I just wanted to dig in a little bit more on the guide as well. Q4 implies essentially flat year-over-year growth and less sequential growth relative to the past six or seven quarters. I guess, what are you seeing so far in the quarter through October that's the driver here? I'm just kind of having trouble squaring the commentary that some of the reps are getting up to speed faster than expected. I would think with many of your reps now getting to that productive kind of six-plus months in their territory point. I'm just kind of having trouble squaring that. Is there conservatism in that guide? I mean, maybe just kind of speak to the moving pieces. Jared OasheimCFO at CVRx00:29:32Yeah. Good question, Chase. I mean, as comparing year-over-year, I think we've talked about this the last few quarters. We had a bit of a reset with our top-line numbers back in Q1. We've been working to grow that number sequentially after that Salesforce transformation took place. We've been seeing that sequential growth rate in the range of 8-10%. I think if I look at the guide that's out here for worldwide numbers for Q4, the midpoint would get us to about 6% sequential growth. A little bit of a step back. I think what we're seeing is more reps are getting up the productivity curve, more territories are becoming active. Again, we just want to make sure that we're kind of through the thick of it here before we would get much more aggressive with the numbers coming out. Jared OasheimCFO at CVRx00:30:18I think even at the midpoint, we're talking growth north of $1 million sequentially from Q3 to Q4. Chase KnickerbockerSenior Research Analyst at Craig–Hallum Capital Group00:30:29Can you maybe speak to kind of how rep tenure has progressed? Any kind of update to any of the turnover metrics, et cetera, just kind of health of the Salesforce update? Jared OasheimCFO at CVRx00:30:44Yeah. I think we last gave updates a couple of months ago on the percentage of reps that were hired in 2024, 2025. We have not seen significant changes there. I think Kevin alluded to this in his prepared remarks that we are back to hiring per normal levels. We are not out there accelerating our hiring to backfill a bunch of reps that were turned over. At this stage, we have not seen significant movement in those percentages of reps that were hired in 2024 and 2025. Chase KnickerbockerSenior Research Analyst at Craig–Hallum Capital Group00:31:18Just last. Jared OasheimCFO at CVRx00:31:19Just to close it out, I mean, overall turnover, kind of returning back to those normal levels. I think we've alluded to it in the past. Annual turnover levels that we think to be normal are kind of in that range of 10–20%. Chase KnickerbockerSenior Research Analyst at Craig–Hallum Capital Group00:31:35Got it. Just maybe on the OPPS, any sort of engagement around Level Six Neurostimulator Code outside of the comments you submitted? Second, Jared, just appreciate those thoughts for 2026. I mean, maybe just also some thoughts on expenses next year, just kind of how you plan to manage the business from an OpEx perspective as we look at 2026. Jared OasheimCFO at CVRx00:32:03Yep. On the OPPS side, I think everybody's sitting and waiting for when that final rule will post. Just a reminder for everybody that CMS did come out this year in the proposed rule back in July that we would be mapped to the new tech APC 1580 for 2026. We don't expect that to change in the final rule, but there is still a chance for some upside where they could create a Level Six Neurostim Code. We're still waiting for that final rule, which we understand could be published any day now. We'll come back and give updates on that as information becomes available. There's no additional information behind the scenes. It's all of us just waiting for CMS to release this rule. On 2026 spend, we do anticipate that we're going to continue to see leverage in this model. Jared OasheimCFO at CVRx00:32:49If we're modeling mid-teens top-line growth with slight improvements on margins, we're not intending all of that gross profit to be spent within operating expenses. We would expect the OPEX growth to be at a lower rate than what we're modeling for top line. Again, we'll come out with more detail on that when we finalize guidance for 2026. Operator00:33:24Our final question comes from Ross Osborne with Cantor Fitzgerald. Please proceed with your question. Ross OsborneDirector and Lead Research Analyst at Fitzgerald00:33:30Hey, guys. Congrats on the progress, and thanks for taking our questions. Maybe just a quick modeling question from us. Your 2025 OpEx guide implies a sequential step down. Is that fair to assume the savings will come from the R&D line sequentially? Jared OasheimCFO at CVRx00:33:46Yeah, it's a good question, Ross. So actually, I think we expect that. Movement would likely happen within SG&A sequentially from Q3–Q4. Q4 is typically a lighter order when it comes to trade show and marketing spend. And so we would typically see a little or fewer dollars going into that bucket in the fourth quarter as compared to the third. Ross OsborneDirector and Lead Research Analyst at Fitzgerald00:34:10Okay. Got it. Then looking at your top accounts doing three or more implants and the highest at greater than 10, are there any structural differences between those averaging three versus 10, or do you think those currently averaging three have the ability to ramp to 10 over time? Kevin HykesPresident and CEO at CVRx00:34:27That's a great question. I'll take that. Thanks, Ross. I would say it's the latter. There are no structural differences there. We think this is ultimately the effect of us sort of steadily improving the mix of accounts that we have and their likelihood of deep adoption and the tools that we're applying to them, this methodical process of getting the right stakeholders in place, getting administrative support in place, and building a robust and resilient network in these accounts that allows them to build this into how they treat the disease. We're pleased with what we're seeing. No reason to believe that they couldn't all be operating at that level. In fact, that's our goal. Ross OsborneDirector and Lead Research Analyst at Fitzgerald00:35:06Great. Thanks for taking our questions. Operator00:35:11We've reached the end of our question and answer session. I would now like to turn the floor back over to Kevin Hykes for closing comments. Kevin HykesPresident and CEO at CVRx00:35:17Thank you, Operator. And thanks to everyone for joining today. We appreciate your continued support and look forward to updating you on our progress next quarter. Thank you. Operator00:35:28This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read moreParticipantsExecutivesMike VallieManaging Director of Healthcare Investor Relations and Capital Markets AdvisoryKevin HykesPresident and CEOJared OasheimCFOAnalystsFrank TakkinenSenior Research Analyst at Lake Street Capital MarketsRoss OsborneDirector and Lead Research Analyst at FitzgeraldAnalyst at JPMorganMax O'BrienAnalyst at William BlairChase KnickerbockerSenior Research Analyst at Craig–Hallum Capital GroupSamantha MunozVP of MedTech Equity Research at Piper SandlerJohn YoungAnalyst at Canaccord GenuityPowered by