CVRX

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET President and Chief Executive Officer - Kevin Hykes Chief Financial Officer - Jared Oasheim Operator: Greetings, and welcome to the CVRx Second Quarter 2026 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to your host, Mike Vallie, with ICR Healthcare. Mike Vallie: Good afternoon. Thank you for joining us today for CVRx's Second Quarter 2026 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 Hykes: Thanks, Mike. Good afternoon, and thank you for joining our second quarter 2026 earnings call. We delivered total revenue of $15.7 million in the second quarter, demonstrating growth of 16% over the same quarter last year, with a gross margin of 87%. Despite the positive quarter, we are seeing signs that the back half of the year will not be as strong as the first. As a result, we've lowered our revenue guidance for the year. My remarks today will cover 3 things: what is driving this change in outlook, what we're doing about it, and the longer-term positive trends that we're seeing. We ended the quarter with 56 sales territories in the U.S., flat compared to the end of the first quarter. It is important to note that roughly 60% of quota-carrying territory managers have joined us in the last 18 months, as we have worked to build the right organization for this next phase of growth. This rapid pace of hiring has strained our onboarding and training processes and the ability of our area sales directors to spend the time necessary to accelerate these new team members up the productivity curve. The scale of the turnover, the slower pace of the territory manager productivity ramp, and the concentration of these new hires in a subset of our regions are the primary factors behind today's guidance update. Importantly, these challenges are not uniform across the business. In the regions where we have limited turnover and stable seasoned leadership executing our Program Development selling strategy, we're seeing strong double-digit growth, which indicates to us that when we have the right conditions in place, our strategy is indeed working. The sales force productivity challenges that we are facing are concentrated in specific regions that have a combination of new leadership and the highest turnover as a result of our sales force restructuring over the last 18 months. The combination of these 2 factors is distracting these regions from fully executing our market development plan, offsetting the success that we're seeing elsewhere in the country. Closing that gap is the focus of the steps that I will walk through next. First, we've continued to improve our hiring process and refine our hiring profiles to make sure that the people we bring on are the right fit from day one, limiting early turnover due to skills or expectations that are not aligned. Second, we are investing significantly in onboarding and training with new resources, roles, and materials designed to get reps productive more quickly. This includes a significant strengthening of our curriculum focused on practical account access skills, as well as extending the onboarding process beyond the initial 3-month didactic phase to an additional 3-month hands-on field mentorship. The objective of these changes is to accelerate time to productivity and to reduce sales director distraction by improving the readiness of our territory managers as they join their teams in the field. Third, we're creating multiple new field-based roles specifically focused on freeing up time for our area sales directors to more fully engage in coaching and developing the territory managers in their regions. This includes field-based reimbursement and business management personnel, as well as 2 vice president-level leaders to better support the area sales directors themselves. These additions are being funded through a reallocation of resources, not incremental spending. And as Jared will point out in his comments today, we are actually lowering our operating expense guidance for the year. And finally, we are redeploying senior leadership talent to roles that can have the fastest and most significant impact on our commercial execution. Our Chief Marketing Officer, Paul Verrastro, one of our most experienced and respected leaders, is moving into a new role providing direct support to our field teams to further accelerate the productivity of our new territory managers and area sales directors. Patrick Lyon, a key addition to our marketing team in Q4 of last year, is being promoted to lead our marketing organization, and we are confident in his ability to build upon Paul's outstanding contributions to date. The second factor that impacts our view on the rest of the year is reimbursement. While there are a number of positive trends, we continue to be challenged by the change in behavior from our largest Medicare Advantage payer. For many quarters, this payer approved close to 80% of our prior authorizations within 30 days of submission, many within days upon receipt. In February, this payer implemented AI-based prior authorization tools, which resulted in an immediate increase in initial denials on the basis of administrative omissions. This was an attempt to comply with the shortened federal requirements for prior authorization review that went into place in January. This caused their 30-day approval rate to fall sharply in February and March to roughly 25%. Our own AI-based tools, discussed on our last call, helped bring that rate back up to approximately 40%. But this payer has since introduced further new tactics for denying claims, and the rate has now fallen back below 30%. As a result, providers who had grown used to approvals from that payer within a matter of days are now waiting far longer and seeing meaningfully lower initial approval rates. That shift has understandably made some physicians more hesitant to recommend Barostim therapy to their patients covered by that plan. Our approach to dealing with this headwind is the same one that ultimately led Humana to issue a favorable written coverage policy earlier this year. We are committed to appealing every prior authorization denial through every stage in the process and to continue these appeals through to an administrative law review, if necessary. Consistent advocacy on behalf of patients, and the successful pursuit of appeals through to the final administrative law stage is what ultimately incentivizes a payer to discuss a formal coverage policy. Outside of this specific payer, the rest of our reimbursement picture is strong and getting stronger. Our overall 30-day Medicare Advantage prior authorization approval rate was 60% for the second quarter as compared to 44% in 2025. The Humana coverage policy is helping drive this progress, with approval rates now above 90%. We now cite the Humana policy in every prior authorization that we file and appeal across every payer, and we are referencing it directly in our ongoing coverage discussions with other national and regional payers. The Category I code implemented in January has further stabilized our experience with traditional Medicare, with approximately 96% of submitted claims for the Barostim procedure now being paid across all 7 Medicare administrative contractors. On the outpatient side, CMS's proposed rule for the 2027 Outpatient Prospective Payment System continues to support Barostim placement in new technology APC 1580 at approximately $45,000 per procedure. We were also pleased to see the final inpatient prospective payment system rule increase the inpatient payment rate for the procedure from $43,000 to $45,000 effective October 1. The previously discussed creation of the field-based reimbursement manager roles is designed to increase our field reimbursement support and to move it closer to the point of customer contact in the field. I will now shift to the longer-term positive trends that we are seeing in the business. First, we continue to believe that our focused playbook is the right one, targeting the right centers and building sustainable programs based on a redundant network of clinical and administrative stakeholders and a defined Barostim workflow. As I mentioned earlier, our regions with stable, seasoned leadership and limited turnover are proving the impact of this approach, and our strong growth in these regions is the clearest validation we have that the strategy itself is working. Our work is now focused on bringing the remaining regions up to that same standard, and we believe the actions we're taking and the investments that we are making will get us there. On the clinical evidence front, I'm pleased to share that the BENEFIT-HF trial is tracking ahead of our internal expectations on both center activations and patient enrollment. We are also significantly increasing our investment in real-world evidence data sets, which we believe can further strengthen the clinical evidence base supporting Barostim. We now have multiple analyses from these data underway, with the first publications expected this fall. In addition, these data could potentially support an expansion of our indication and label, leveraging the new FDA real-world evidence pathway. We believe that this could potentially be a viable regulatory pathway for CVRx, and we will keep you updated on this effort as it progresses. Before turning the call over to Jared, I'd like to provide an additional update. In May of 2026, we received a civil investigative demand from the U.S. Department of Justice related to certain sales and marketing practices as described in our 10-Q. We are fully cooperating with the investigation. Jared will now walk through our financial results and our updated guidance for the year. Jared Oasheim: Thanks, Kevin. Unless otherwise stated, year-over-year comparisons are for the 3 months ended June 30, 2026, compared to the 3 months ended June 30, 2025. Total revenue was $15.7 million, an increase of $2.1 million, or 16%. Revenue in the U.S. was $14.8 million, an increase of $2.5 million, or 21%. Revenue units in the U.S. totaled 466 compared to 391. 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. We ended the quarter with a total of 258 active implanting centers as compared to 240 as of June 30, 2025. As of June 30, 2026, the number of sales territories in the U.S. is 56 as compared to 47 as of June 30, 2025. Based on the current tenure of our team, and as we focus on driving productivity in our existing territories, we are not anticipating adding any more sales territories for the balance of the year. Revenue in Europe was $0.9 million, a decrease of $0.4 million, or 31%. Total revenue units in Europe decreased to 40 from 61 in the prior year period. The number of sales territories in Europe remained consistent at 5. Gross profit was $13.7 million, an increase of $2.3 million, or 20%. Gross margin increased to 87% compared to 84% a year ago. R&D expenses increased $0.7 million to $3.1 million. This change was driven mainly by an increase in headcount expenses and clinical trial expenses. SG&A expenses increased $0.3 million, or 1%, to $23.6 million. This change was primarily driven by an increase in non-cash, stock-based compensation expenses and legal expenses, partially offset by a decrease in advertising expenses and travel expenses. Interest expense increased $0.1 million to $1.6 million. This increase was driven by interest expense on the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income net decreased $0.5 million to $0.6 million. This balance consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $14 million, or $0.53 per share, compared to a net loss of $14.7 million, or $0.57 per share. Net loss per share was based on 26.5 million and 26.1 million weighted average shares outstanding, respectively. As of June 30, 2026, cash and cash equivalents were $64.6 million. Net cash used in operating and investing activities was $8.9 million as compared to $8 million. Now turning to guidance. For the full year of 2026, we now expect total revenue between $58 million and $60 million. We now expect full year gross margin between 86% and 87%. We now expect operating expenses to be between $99 million and $101 million. For the third quarter of 2026, we expect to report total revenue between $13.5 million and $14.5 million. With that, I'll now turn the call back over to Kevin for closing remarks. Kevin Hykes: Before we close, I'd like to provide an update on our leadership team. We recently welcomed Matt Klein as our new Vice President of Legal at CVRx, a seasoned medical device legal executive, most recently with Silk Road Medical and Boston Scientific. We're also making progress on our search for our next Chief Financial Officer. Jared has been an important part of this company for over a decade, and we're pleased with the quality of the candidates who are interested in succeeding him in this role. While we're pleased with the performance year-to-date, we are not satisfied with the outlook for the balance of the year, and we clearly have more work to do as it relates to sales execution. We are working hard to improve the hiring and onboarding process for the sales team, as well as improving sales director bandwidth and support with new field-based roles to accelerate more of our sales reps up the productivity curve. Despite these short-term sales execution challenges, we remain confident in the fundamentals of this business and the unique opportunity that we have to introduce device therapy to treat a disease that has been managed exclusively with pharmaceuticals for over 50 years. Our highly differentiated therapy is based on the same fundamental and accepted mechanism of action that underlies today's guideline-based pharmacologic therapy. We have a $10 billion market opportunity with little to no device-based competition today or on the near-term horizon. While admittedly bumpy, we are nonetheless making steady progress on patient access, the most fundamental issue facing any new therapy, with a recent Category I code, steadily improving Medicare Advantage approval rates, consistent payment for traditional Medicare patients, and our first-ever written coverage policy from the second largest Medicare Advantage payer in the United States. This coverage policy opens the next chapter in our patient access work and facilitates a very different level of conversation with other Medicare Advantage and commercial payers, paving the way towards additional coverage policies in the future. We have also meaningfully strengthened the evidence base underlying Barostim therapy over the last 18 months, including significant publications on hospitalization reduction and other important clinical and physiologic endpoints. We have numerous additional publications on the horizon and are seeing enthusiasm from and positive engagement by the heart failure community on the BENEFIT-HF trial, the largest therapeutic device trial in the history of the field, which, if successful, will triple our total addressable market. Changing any disease treatment paradigm is difficult, particularly in a conservative specialty like heart failure, but we are making progress each and every day. With the right commercial structure and stronger sales execution, the momentum we are building in patient access and evidence, and a number of positive catalysts on the horizon, we are confident that we will ultimately be successful. Before we close, I'd like to thank the employees of CVRx for their persistence and commitment to supporting the more than 7,000 patients who have benefited from Barostim therapy, as well as the many more whose lives can be positively impacted. We are working as one team to support our sales leaders and their field teams to address the headwinds that we've discussed on this call. The consistent and undeniable impact that our therapy has on the lives of people suffering from heart failure is what drives and inspires our team each and every day. Now, I'd like to open the line for questions. Operator? Operator: [Operator Instructions] One moment, please, while we poll for questions. Our first question comes from the line of Brandon Vazquez with William Blair. Max Kruszeski: It's Max on for Brandon. Can you hear me all right? Kevin Hykes: Yes. Max Kruszeski: Kevin, I guess I'll just start on the commercial front. Earlier in your prepared remarks, you called out the regions with higher turnover. Is this additional turnover outside of what you guys are seeing normally? And I guess if so, how many of these reps leaving are those you guys were expecting to be fully ramped by now? I guess I'm just trying to get a feel for where we now stand in the ramp of those existing reps since the commercial realignment and the ramp of new ones going forward. Kevin Hykes: Yes, thanks, Max. So I would say it's a combination of things. The overall scale of the turnover that we've experienced over the last 18 months as part of this transition, including continuing turnover in 2Q that is higher than we would have liked, has led to some of these challenges. And I can't characterize the percent that are more recent hires. The bulk of them are from the earlier years of the company. But this is the dynamic that's putting pressure on our onboarding and training processes. And that is leading to slower productivity ramps than we had anticipated seeing from this group, both in recently activated territories that aren't ramping up as quickly as they should or historically have, as well as our ability to move some of these new hires from the bench into new active territories. So as Jared mentioned, or as we mentioned on the call, the dynamic is in fact concentrated in a handful of regions who unfortunately also have our least tenured leaders leading those regions. So it's a bit of a double whammy. Max Kruszeski: Got it. And then, Jared, maybe one for you. Kevin, maybe you as well. But just on total center adds, on a net basis, you guys only added one since Q1. How should we think about this for the remainder of the year, considering these sales force changes and you guys are still likely closing those lower-tiered accounts through the remainder of 2026? Jared Oasheim: Hi, Max, thanks for the question. Yes, so with the one center add, that wasn't too much of a shock to us. Again, our strategy has been focused on driving deeper adoption within the centers that are active. Obviously, there's been a bit of change out as we continue to add the right types of centers and sunset some of those dabblers that we've talked about in previous quarters. As we look to the balance of the year, a large portion of our growth in centers comes along with new territories. As we've talked about in the past, each territory manager is directed to activate somewhere in the range of 3 to 5 centers. If we now, for the balance of the year, do not anticipate activating any new territories, it's unlikely we'd see net growth in that center number for the balance of the year. But that also aligns with this strategy of driving deeper adoption at each one of these centers. Operator: Our next question comes from the line of Chase Knickerbocker with Craig-Hallum Capital Group. Chase Knickerbocker: Kevin, maybe it would be helpful for us if you could kind of present us with some like a cohort of sorts as far as the kind of the reps where you're still seeing that double-digit growth that you mentioned, kind of what portion of your rep base are you still seeing that in? What is the characteristics as far as kind of tenure, et cetera and then kind of compare that to the territories in which you're having problems as far as kind of how distinct that performance is. If you can get into a little bit more detail there, I think that would be helpful to kind of frame up the issue. Kevin Hykes: Yes, thanks, Chase. Yes, so in the majority of our regions, we have relatively limited turnover over the last 18 months. In those regions, we also have our most tenured leaders, and so what we're seeing there is when they are applying our Program Development strategy and they're focused on 4 key selling activities that we've identified as the core elements of our pipeline, they are growing in the strong double digits consistently. So conversely, in the regions where slightly less than half, where we have the highest rates of turnover, which are well north of 50% in some cases, and we also have our least tenured leaders, we are seeing negative implant growth rates year-to-date, effectively offsetting the strong growth we're seeing in the regions that are in fact executing our strategy. So pretty stark differences in turnover rates, in tenure, in leadership, and in the execution of the strategy itself. We track those 4 metrics very closely so we can tell where the strategy is in fact being delivered and where we're still struggling to do that. And I should have mentioned earlier, in effect, we have overwhelmed, and I take full responsibility for this, we have overwhelmed our ability to onboard this many people simultaneously or over a 3 or 4-quarter extended period. And we are not seeing the productivity ramp that we were used to seeing under more stable conditions. And that is what's driving these challenges. Unfortunately, as I said, it's heavily concentrated in a number of regions where we're also onboarding new leaders. So that's made the problem worse. Chase Knickerbocker: Got it. Jared, if we kind of go over to OpEx guidance. Is it fair to say that the majority of the cost savings in that guidance is from the kind of removal of the expected hiring of those additional sales territories? Or where else is that cost savings coming from? And then kind of the second piece to that is just where you kind of think there might be some additional savings to find as we think about the cost base kind of going into next year. Jared Oasheim: Yes, happy to take that question on OpEX, Chase. Just to close up maybe a little bit on what Kevin mentioned as well is, I think that's one of the key points for us is continuing to highlight that in those 5 regions with stable leaders and with limited turnover, where we're seeing this strategy play out, we are seeing those high double-digit growth. So I think highlighting that piece of it that it is working in the areas where we have stability is really important. I think as we turn towards the OpEX, so seeing a reduction in the top-line guidance, that is partially responsible for driving down the OpEx guide, but not wholly. We've also pulled back spending in certain other projects within marketing and development areas so that we could redeploy some additional resources, as Kevin mentioned in the prepared remarks, to sales to help these reps get up that productivity curve a little bit faster. So that's supporting them in the onboarding process and the training process and through our sales leadership team. So there is a partial connection to seeing a reduction in OpEx to bringing down the top-line guide, but there's also some intentional reductions in spending that are being brought forward there. As we think about 2027, again, we're looking for leverage in this model as we continue to grow this business. I think we've seen that in the front half of this year as we've grown top line at a significantly higher rate than what we've grown OpEx year-to-date. That will continue to be a focus for the company as we move into 2027 and beyond. Operator: Our final question comes from the line of Robbie Marcus with JPMorgan. Robert Marcus: With now basically 3 years in that $50 million to $60 million revenue range and expenses, plus or minus $100 million a year, are you coming to a point where it's not an execution issue but more a demand issue? And maybe the follow-up to that question is, given where the cash balance is and the cash flow burn, where you stand today in the lower guidance, how are you thinking about cash needs moving forward? Kevin Hykes: Yes. Thanks, Robbie. So it's Kevin. I'll maybe take the first part of that question. So we believe, and we believe where we are applying our strategy of driving deep adoption and creating sustainable programs as we lower the 3 barriers to adoption for this therapy, evidence, awareness, and patient access, we are in fact growing this business. We know that this therapy works. We are dramatically increasing the evidence that proves that it works. We are convincing payers, including Medicare, now paying at 96%, that this works and is an important therapy for these patients. Market development is difficult in any setting. It's particularly difficult in heart failure. These are among the most conservative cardiologists or physicians, for that matter, that I've ever worked with. So it is not easy, and it's not linear, and it's tough work. But we believe we have a very important therapy that can help a significant number of patients in a disease state that's been treated with drugs for 50 years. So unfortunately, I believe our problem today is in fact execution and the demand piece of this is getting better and better with each successive improvement in patient access and each additional publication that we produce demonstrating why it works. So I guess on some levels, the execution piece, I take responsibility for that. That is fixable, and we are going to fix it. And I can't necessarily say that about evidence or patient access. So thankfully, in those tough areas, we are making progress. And what we've got here is an execution problem that we need to fix. And we are confident we have the right plans in place to do that. Jared Oasheim: And Robbie, I can cover the second part of the question related to cash. So as of today, we believe we have at least 18 months of cash left on the balance sheet and $40 million remains undrawn under our debt facility. As we've said, you know, for several quarters, maybe even more than a year at this point, we may be opportunistic to raise funds to bolster the balance sheet to continue to invest in this business. But at the same point, we're going to be very thoughtful on where we're spending our money to make sure that this cash lasts as long as possible here. Operator: Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. Hykes for any final comments. Kevin Hykes: Thank 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. Operator: Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributed the lowered revenue guidance to a rapid hiring pace that overwhelmed onboarding and training processes, leading to slower-than-expected territory manager productivity ramps. Performance is bifurcated, with regions featuring stable, seasoned leadership showing strong double-digit growth, while regions with high turnover and new leadership are seeing negative implant growth. The company is seeing a significant headwind from its largest Medicare Advantage payer, which implemented AI-based tools that dropped prior authorization approval rates from 80% to below 30%. Despite commercial execution issues, management maintains that the underlying strategy is working in stable regions and that the $10 billion market opportunity remains intact with little device competition. The company is shifting resources to create new field-based roles, such as reimbursement and business management personnel, to free up sales directors for coaching and development. Management confirmed receipt of a civil investigative demand from the U.S. Department of Justice regarding certain sales and marketing practices and is fully cooperating. CVRx does not anticipate adding any new sales territories for the remainder of the year, focusing instead on driving productivity within the existing 56 territories. The company is extending the onboarding process from a 3-month didactic phase to include an additional 3-month hands-on field mentorship to accelerate rep readiness. Management is pursuing a strategy of appealing every prior authorization denial through to administrative law review to incentivize payers to establish formal coverage policies. The BENEFIT-HF trial is tracking ahead of internal expectations for enrollment, and the company is exploring a potential regulatory pathway for label expansion using real-world evidence. Operating expense guidance was lowered to $99 million to $101 million, reflecting a reallocation of resources and a pullback in certain marketing and development projects. The Humana coverage policy is driving approval rates above 90%, and the company is now citing this policy in all prior authorization filings across other payers. CMS proposed and final rules for 2027 and 2026 support stable or increased payment rates for Barostim procedures in both outpatient and inpatient settings. The company is currently searching for a new Chief Financial Officer to succeed Jared Oasheim, who has been with the firm for over a decade. Cash and cash equivalents of $64.6 million are expected to provide at least 18 months of runway, with $40 million remaining undrawn on a debt facility. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Turnover is concentrated in a handful of regions where leadership is also least tenured, creating a 'double whammy' effect on productivity. Management admitted to overwhelming the organization's ability to onboard the volume of new hires brought on over the last 18 months. Net growth in active implanting centers is unlikely for the balance of the year because center adds are typically tied to new territory activations, which have been paused. The focus has shifted toward driving deeper adoption within the existing 258 active centers and sunsetting 'dabbler' accounts. Management insists the problem is execution-based rather than a lack of demand, noting that market development in heart failure is non-linear and difficult. Evidence and patient access metrics are improving, which management views as harder to fix than the current internal sales execution hurdles.

Interested in CVRx, Inc.? Here are five stocks we like better. CVRx lowered its 2026 outlook due to sales-force turnover, slower territory-manager productivity ramps and reimbursement challenges. Full-year revenue is now expected at $58 million–$60 million, with third-quarter revenue projected at $13.5 million–$14.5 million. Second-quarter revenue rose 16% to $15.7 million and gross margin improved to 87%, driven by 21% growth in U.S. revenue. However, European revenue fell 31%, and the company plans to focus on improving existing territories rather than adding sales regions for the rest of 2026. Medicare Advantage reimbursement remains a headwind after one major payer’s AI-based authorization process sharply reduced initial approval rates, discouraging some physicians from recommending Barostim. CVRx also disclosed a U.S. Department of Justice investigation into certain sales and marketing practices and said it is cooperating. CVRx (NASDAQ:CVRX) reported second-quarter revenue growth and an improved gross margin, but lowered its full-year outlook as sales-force turnover, slower productivity ramps and reimbursement challenges with a large Medicare Advantage payer are expected to weigh on results in the second half of 2026. The company posted second-quarter revenue of $15.7 million, up 16% from a year earlier, while gross margin rose to 87% from 84%. U.S. revenue increased 21% to $14.8 million, supported by growth in the company’s heart failure business, new accounts and awareness of its Barostim therapy. However, European revenue declined 31% to $0.9 million. → 3 Drone Stocks That Should Soar After the Summer Slump CVRx narrowed its full-year revenue expectation to between $58 million and $60 million and said it expects third-quarter revenue of $13.5 million to $14.5 million. The company also reduced its expected operating expenses for the year to $99 million to $101 million. President and Chief Executive Officer Kevin Hykes said the company’s commercial challenges were concentrated in particular U.S. regions that have experienced elevated turnover and less-tenured sales leadership. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth CVRx ended the quarter with 56 U.S. sales territories, unchanged from the first quarter. About 60% of quota-carrying territory managers joined the company during the past 18 months, Hykes said, straining the company’s onboarding and training infrastructure and reducing the time area sales directors could devote to coaching representatives. “The scale of the turnover, the slower pace of the territory manager productivity ramp, and the concentration of these new hires in a subset of our regions are the primary factors behind today’s guidance update,” Hykes said. → Jersey Mike's Serves Fresh Gains After IPO Stumble In regions with experienced leadership and limited turnover, CVRx said it continued to see strong double-digit growth under its program-development selling strategy. By contrast, Hykes said regions with the highest turnover—more than 50% in some cases—and the least-tenured leaders have experienced negative implant growth year to date. The company does not anticipate adding U.S. sales territories during the remainder of 2026, Chief Financial Officer Jared Oasheim said. CVRx plans instead to focus on improving productivity in existing territories and driving deeper adoption at active implanting centers. CVRx had 258 active implanting centers at June 30, compared with 240 a year earlier. Management said net center growth is unlikely for the balance of the year because new center activations have historically accompanied new territory launches, while the company also continues to sunset lower-volume “dabbling” accounts. To address commercial execution issues, CVRx is refining its hiring profiles, expanding onboarding and training resources, and extending its development process. The company said the program will now include an additional three months of hands-on field mentorship following an initial three-month didactic phase. The company is also creating field-based reimbursement and business-management roles intended to free area sales directors to spend more time coaching territory managers. It has added two vice president-level leadership positions to support area sales directors. Hykes said the new roles will be funded through resource reallocation rather than incremental spending. Oasheim said lower operating-expense guidance reflects both reduced revenue expectations and intentional spending reductions in marketing and development projects, with some resources redirected toward sales training and leadership support. CVRx also moved Chief Marketing Officer Paul Verrastro into a new role supporting field teams directly. Patrick Lyon, who joined the marketing organization in the fourth quarter of 2025, was promoted to lead marketing. The company additionally named Matt Klein as vice president of legal and said it continues to search for a successor to Oasheim as CFO. Hykes said reimbursement trends outside one major Medicare Advantage payer continue to improve, but that payer’s adoption of artificial intelligence-based prior-authorization tools in February has led to more initial denials tied to administrative omissions. The payer’s 30-day approval rate fell to roughly 25% in February and March from nearly 80% previously, according to Hykes. CVRx’s own AI tools helped raise that rate to about 40%, but the company said the rate subsequently dropped below 30% after the payer introduced additional denial tactics. CVRx said the longer wait times and lower initial approval rate have made some physicians more hesitant to recommend Barostim therapy for patients covered by that plan. The company said it intends to appeal every denial through all stages, including administrative law review when needed. Overall, the company reported a 60% 30-day Medicare Advantage prior-authorization approval rate in the second quarter, compared with 44% in 2025. Humana’s written coverage policy has supported that improvement, with approval rates above 90%, Hykes said. Traditional Medicare paid approximately 96% of submitted Barostim procedure claims across all seven Medicare administrative contractors. CMS proposed maintaining Barostim in new technology APC 1580, with outpatient payment of approximately $45,000 per procedure for 2027. The final inpatient payment rule raised the procedure’s payment rate from $43,000 to $45,000, effective Oct. 1. Second-quarter gross profit increased 20% to $13.7 million. Research and development expense rose $0.7 million to $3.1 million, primarily due to headcount and clinical-trial costs. Selling, general and administrative expense increased 1% to $23.6 million, reflecting higher stock-based compensation and legal expenses, partly offset by lower advertising and travel expenses. CVRx reported a net loss of $14 million, or $0.53 per share, compared with a loss of $14.7 million, or $0.57 per share, a year earlier. Cash and cash equivalents totaled $64.6 million at June 30. Oasheim said management believes the company has at least 18 months of cash available and retains $40 million of undrawn capacity under its debt facility. The company said its BENEFIT-HF trial is ahead of internal expectations for center activations and patient enrollment. CVRx is also increasing investment in real-world evidence datasets, with initial publications expected this fall. Hykes said those data could potentially support an expanded indication and label through the FDA’s real-world evidence pathway. Separately, Hykes disclosed that CVRx received a civil investigative demand from the U.S. Department of Justice in May related to certain sales and marketing practices. He said the company is fully cooperating with the investigation. CVRx, Inc 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "CVRx Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Total Revenue: $15.7 million, up 16% year-over-year. US Revenue: $14.8 million, up 21% year-over-year. Europe Revenue: $0.9 million, down 31% year-over-year. Gross Margin: 87%, up from 84% a year ago. Net Loss: $14 million, or $0.53 per share, compared to a net loss of $14.7 million, or $0.57 per share, in the prior year. R&D Expenses: $3.1 million, up $0.7 million year-over-year. SG&A Expenses: $23.6 million, up 1% year-over-year. Cash and Cash Equivalents: $64.6 million as of June 30, 2026. US Revenue Units: 466, compared to 391 in the prior year period. Europe Revenue Units: 40, down from 61 in the prior year period. Active Implanting Centers: 258, compared to 240 as of June 30, 2025. US Sales Territories: 56, flat compared to the end of the first quarter. Full Year 2026 Revenue Guidance: Lowered to between $58 million and $60 million. Full Year 2026 Gross Margin Guidance: Between 86% and 87%. Full Year 2026 Operating Expense Guidance: Between $99 million and $101 million. Third Quarter 2026 Revenue Guidance: Between $13.5 million and $14.5 million. Warning! GuruFocus has detected 4 Warning Signs with CVRX. Is CVRX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. CVRx Inc (NASDAQ:CVRX) delivered total revenue of $15.7 million in Q2 2026, a 16% increase year-over-year, with gross margin expanding to 87%. The company's strategy is validated by strong double-digit growth in regions with stable, seasoned leadership and limited turnover. Reimbursement is improving, with overall 30-day Medicare Advantage prior authorization approval rates rising to 60% in Q2 from 44% in 2025, and Humana's coverage policy driving approval rates above 90%. Traditional Medicare claims for the Barostim procedure are now being paid at approximately 96% across all seven Medicare administrative contractors, and CMS has increased the inpatient payment rate to $45,000. The BENEFIT-HF trial is tracking ahead of internal expectations on both center activations and patient enrollment, and the company is investing in real-world evidence that could potentially support an expanded indication. The company is taking decisive action to fix sales execution issues by investing in onboarding, training, and new field-based roles, funded through reallocation of resources and lower operating expense guidance. CVRx Inc (NASDAQ:CVRX) lowered its full-year 2026 revenue guidance to between $58 and $60 million due to weaker-than-expected back-half performance. Sales force productivity is challenged by high turnover, with roughly 60% of quota-carrying territory managers having joined in the last 18 months, straining onboarding and training processes. The company's largest Medicare Advantage payer implemented AI-based prior authorization tools, causing its 30-day approval rate to fall sharply to below 30%, making physicians hesitant to recommend Barostim. The company is not anticipating adding any new sales territories for the balance of the year, which will likely limit net growth in active implanting centers. Revenue in Europe decreased by 31% year-over-year, with total revenue units dropping to 40 from 61 in the prior year period. CVRx Inc (NASDAQ:CVRX) received a civil investigative demand from the US Department of Justice in May 2026 related to certain sales and marketing practices, and the company is fully cooperating with the investigation. Q: Is the recent sales force turnover and slower productivity ramp a new development, and how much of the current team is still ramping up?A: Kevin Hykes (CEO) explained that the challenges stem from the scale of turnover experienced over the last 18 months, which continued into Q2 at higher-than-desired levels. Roughly 60% of quota-carrying territory managers have joined in the last 18 months, straining onboarding processes and slowing productivity ramps. This issue is concentrated in a handful of regions with the least tenured leaders, creating a "double whammy" effect that has offset strong growth seen in more stable regions. Q: Can you provide more detail on the stark performance difference between regions with stable leadership versus those with high turnover?A: Kevin Hykes (CEO) noted that in the majority of regions with limited turnover and tenured leaders executing the program development strategy, they are seeing consistent strong double-digit growth. Conversely, in regions with turnover rates well north of 50% and less tenured leaders, they are seeing negative implant growth rates year-to-date. This stark contrast validates that the strategy works when properly executed, but the company has overwhelmed its onboarding capacity, which is the primary driver of the current execution problem. Q: Given the flat center count and the pause on new territories, how should we think about center adds for the rest of the year?A: Jared Oasheim (CFO) stated that the one net center add in Q2 was not a shock, as the strategy focuses on driving deeper adoption within existing active centers. Since a large portion of center growth comes from new territory activation, and the company is not anticipating adding new territories for the balance of the year, it is unlikely they will see net growth in the center count. This aligns with the strategy of deepening adoption at each center rather than expanding the footprint. Q: Is the lower operating expense guidance primarily due to the removal of expected hiring for new sales territories, or are there other cost savings?A: Jared Oasheim (CFO) clarified that while the reduced top-line guidance partially drives the OPEX reduction, it is not the only factor. The company has intentionally pulled back spending on certain marketing and development projects to redeploy resources toward sales onboarding and training. This is designed to help new reps get up the productivity curve faster. Looking ahead to 2027, the company remains focused on finding leverage in the model as it continues to grow. Q: With revenue stuck in the $50-$60 million range for three years, is this an execution issue or a demand issue? And how are you thinking about cash needs?A: Kevin Hykes (CEO) firmly stated that this is an execution problem, not a demand issue. He emphasized that the therapy works, evidence is growing, and payer access is improving (e.g., 96% Medicare payment rate). Market development in heart failure is inherently difficult and non-linear, but the company is confident in its strategy. Jared Oasheim (CFO) added that the company has at least 18 months of cash on hand, with $40 million undrawn on its debt facility, and will be thoughtful about spending while remaining opportunistic about raising funds to bolster the balance sheet. Q: What specific actions are being taken to address the sales execution challenges and accelerate the productivity of new territory managers?A: Kevin Hykes (CEO) outlined a multi-pronged approach: 1) Refining hiring profiles to ensure better fit from day one; 2) Significantly investing in onboarding and training, including extending the process from a three-month didactic phase to an additional three-month hands-on field mentorship; 3) Creating new field-based roles (reimbursement and business management) to free up area sales directors for coaching; and 4) Redeploying senior leadership, including moving the Chief Marketing Officer into a direct field support role. These changes are funded through reallocation, not incremental spending. Q: Can you elaborate on the reimbursement challenges with the largest Medicare Advantage payer and the impact on physician behavior?A: Kevin Hykes (CEO) detailed that this payer historically approved ~80% of prior authorizations within 30 days, but in February 2026, they implemented AI-based tools that caused initial denial rates to spike. Despite CVRx's own AI tools bringing the approval rate back to ~40%, the payer introduced new denial tactics, dropping the rate back below 30%. This has made physicians hesitant to recommend Barostim for patients covered by that plan. The company's strategy is to appeal every denial through to administrative law review, a process that previously incentivized Humana to issue a favorable coverage policy. Q: Despite the headwinds, what positive reimbursement trends are you seeing that support the long-term thesis?A: Kevin Hykes (CEO) highlighted several positive trends: The overall 30-day Medicare Advantage prior authorization approval rate improved to 60% in Q2 2026 from 44% in 2025, driven by the Humana coverage policy (now with approval rates above 90%). The Category 1 code has stabilized traditional Medicare, with ~96% of claims paid across all contractors. CMS's proposed 2027 OPPS rule supports Barostim displacement at ~$45,000 per procedure, and the final inpatient rule increased the payment rate to $45,000 effective October 1st. Q: What is the status of the BENEFIT-HF trial and other evidence-generation efforts?A: Kevin Hykes (CEO) shared that the BENEFIT-HF trial is tracking ahead of internal expectations on both center activations and patient enrollment. The company is also significantly increasing investment in real-world evidence data sets, with multiple analyses underway and first publications expected this fall. These data could potentially support an expansion of the indication and label, leveraging the new FDA real-world evidence pathway, which the company believes could be a viable regulatory route. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the second quarter of 2026. Recent Highlights Total revenue for the second quarter of 2026 was $15.7 million, an increase of approximately 16% over the prior year quarter U.S. revenue for the second quarter of 2026 was $14.8 million, an increase of 21% over the prior year quarter Active implanting centers in the U.S. grew to 258 as of June 30, 2026, as compared to 240 as of June 30, 2025 Humana issued a Medicare Advantage coverage policy, effective May 1, 2026 for Barostim therapy, which is the first coverage policy of its kind for Barostim "We are pleased with the strong revenue growth and margin performance in the second quarter along with the reimbursement progress we made, including the new Medicare Advantage coverage policy from Humana. However, we are not satisfied with our updated outlook for the balance of the year, driven by fewer sales territories than anticipated, lower sales force productivity and a prolonged challenge with one of our largest payers,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are taking direct action to address these headwinds, and our confidence in the long-term fundamentals of this business remains high, supported by strong growth observed in our most stable regions and encouraging early progress on the BENEFIT-HF trial and our broader clinical and reimbursement strategies." Second Quarter 2026 Financial and Operating Results Revenue was $15.7 million for the three months ended June 30, 2026, an increase of $2.1 million, or 16%, over the three months ended June 30, 2025. Revenue generated in the U.S. was $14.8 million for the three months ended June 30, 2026, an increase of $2.5 million, or 21%, over the three months ended June 30, 2025. Revenue units in the U.S. totaled 466 and 391 for the three months ended June 30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of June 30, 2026, the Company had a total of 258 active implanting centers in the U.S., as compared to 240 as of June 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of June 30, 2026, the number of sales territories in the U.S. is 56 as compared to 47 sales territories as of June 30, 2025. Revenue generated in Europe was $0.9 million for the three months ended June 30, 2026, a decrease of $0.4 million, or 31%, compared to the three months ended June 30, 2025. Total revenue units in Europe decreased to 40 for the three months ended June 30, 2026, from 61 in the prior year period. The number of sales territories in Europe remained consistent at five as of June 30, 2026. Gross profit was $13.7 million for the three months ended June 30, 2026, an increase of $2.3 million, or 20%, over the three months ended June 30, 2025. Gross margin was 87% and 84% for the three months ended June 30, 2026 and June 30, 2025, respectively. R&D expenses increased $0.7 million, or 27%, to $3.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was driven by a $0.6 million increase in headcount expenses and a $0.1 million increase in clinical trial expenses. SG&A expenses increased $0.3 million, or 1%, to $23.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was primarily driven by a $0.7 million increase in non-cash stock-based compensation expenses and a $0.5 million increase in legal expenses, partially offset by a $0.6 million decrease in advertising expenses and a $0.3 million decrease in travel expenses. Interest expense increased $0.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, driven by interest expense on the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.6 million and $1.1 million for the three months ended June 30, 2026 and 2025, respectively. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $14.0 million, or $0.53 per share, for the three months ended June 30, 2026, compared to a net loss of $14.7 million, or $0.57 per share, for the three months ended June 30, 2025. Net loss per share was based on 26.5 million weighted average shares outstanding for three months ended June 30, 2026 and 26.1 million weighted average shares outstanding for the three months ended June 30, 2025. As of June 30, 2026, cash and cash equivalents were $64.6 million. Net cash used in operating and investing activities was $8.9 million for the three months ended June 30, 2026, compared to $8.0 million for the three months ended June 30, 2025. Humana Medicare Advantage Coverage Policy In May 2026, Humana issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. Humana, a national health insurance company with the second largest Medicare Advantage program in the U.S., provides coverage to approximately 5.2 million Medicare Advantage members across 46 states. The policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the BENEFIT-HF trial. This is now the third significant reimbursement development for Barostim this year, following the transition to Category I CPT codes and CMS approval of Category B IDE coverage for BENEFIT-HF patients, each of which took effect in the first quarter of 2026. Business Outlook For the full year of 2026, the Company now expects: Total revenue between $58.0 million and $60.0 million; Gross margin between 86% and 87%; Operating expenses between $99.0 million and $101.0 million. For the third quarter of 2026, the Company expects to report total revenue between $13.5 million and $14.5 million. Webcast and Conference Call Information The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and third quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR [email protected] Media Contact:Emily Meyers CVRx, Inc. [email protected]

There's been a major selloff in CVRx, Inc. (NASDAQ:CVRX) shares in the week since it released its quarterly report, with the stock down 22% to US$5.74. The results overall were pretty much dead in line with analyst forecasts; revenues were US$15m and statutory losses were US$0.50 per share. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Taking into account the latest results, the most recent consensus for CVRx from seven analysts is for revenues of US$65.3m in 2026. If met, it would imply a solid 10% increase on its revenue over the past 12 months. Losses are expected to hold steady at around US$1.95. Yet prior to the latest earnings, the analysts had been forecasting revenues of US$65.0m and losses of US$1.98 per share in 2026. View our latest analysis for CVRx As a result there was no major change to the consensus price target of US$11.17, implying that the business is trading roughly in line with expectations despite ongoing losses. The consensus price target is just an average of individual analyst targets, so - it could be handy to see how wide the range of underlying estimates is. There are some variant perceptions on CVRx, with the most bullish analyst valuing it at US$14.00 and the most bearish at US$6.00 per share. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business. Taking a look at the bigger picture now, one of the ways we can understand these forecasts is to see how they compare to both past performance and industry growth estimates. It's pretty clear that there is an expectation that CVRx's revenue growth will slow down substantially, with revenues to the end of 2026 expected to display 14% growth on an annualised basis. This is compared to a historical growth rate of 34% over the past five years. By way of comparison, the other companies in this industry with analyst coverage are forecast to grow their revenue at 8.0% annually. So it's pretty clear that, while CVRx's revenue growth is expected to slow, it's still expected to grow faster than the industry itself. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. Fortunately, they also reconfirmed their revenue numbers, suggesting that it's tracking in line with expectations. Additionally, our data suggests that revenue is expected to grow faster than the wider industry. The consensus price target held steady at US$11.17, with the latest estimates not enough to have an impact on their price targets. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have forecasts for CVRx going out to 2028, and you can see them free on our platform here. And what about risks? Every company has them, and we've spotted 3 warning signs for CVRx you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Interested in CVRx, Inc.? Here are five stocks we like better. CVRx topped first-quarter expectations with revenue of $14.8 million, up 20% year over year, driven mainly by a 22% increase in U.S. revenue from its Barostim heart failure business. Profitability metrics improved as gross margin expanded to 87% from 84% and net loss narrowed slightly to $13.1 million, while the company ended the quarter with $72.3 million in cash. Management highlighted reimbursement and clinical progress, including improved prior authorization rates under new Medicare Advantage rules and the first patient enrollment in the BENEFIT-HF trial, which could significantly expand Barostim’s addressable market if successful. CVRx (NASDAQ:CVRX) reported first-quarter 2026 revenue of $14.8 million, up 20% from the prior-year period, as U.S. growth in its Barostim heart failure business helped the company exceed the high end of its guidance range, executives said on the company’s earnings call. President and Chief Executive Officer Kevin Hykes said the quarter showed “early evidence” that investments made during 2025 are beginning to translate into results. Those efforts included strengthening the sales organization, refining the company’s go-to-market strategy, advancing reimbursement initiatives and securing approval for the BENEFIT-HF clinical trial. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum “The Q1 reflects positive momentum across every part of our business,” Hykes said. “Our sales team is executing, the reimbursement environment is improving, and our clinical evidence program is advancing on schedule.” Chief Financial Officer Jared Oasheim said U.S. revenue was $13.7 million in the quarter, an increase of $2.5 million, or 22%, from the first quarter of 2025. U.S. revenue units totaled 429, compared with 359 in the prior-year period. → 3 Ways to Target the Resources Powering AI and Data Centers Oasheim attributed the U.S. gains primarily to continued growth in the heart failure business, including expansion into new sales territories and accounts, as well as increased physician and patient awareness of Barostim. The company ended the quarter with 257 active implanting centers, up from 252 at the end of 2025. CVRx also had 56 U.S. sales territories at quarter-end, compared with 53 at the end of 2025 and 45 as of March 31, 2025. → MercadoLibre Boldly Invests in Growth: Discount Deepens European revenue was $1.1 million, down $27,000, or 2%, from a year earlier. Revenue units in Europe declined to 56 from 59, while the number of European sales territories remained at five. Gross profit was $12.9 million, up 25% year over year, while gross margin improved to 87% from 84%. Oasheim said the increase reflected a higher average selling price and lower cost per unit, primarily due to improved manufacturing efficiencies. CVRx reported a first-quarter net loss of $13.1 million, or 50 cents per share, compared with a net loss of $13.8 million, or 53 cents per share, in the first quarter of 2025. The per-share results were based on 26.4 million weighted average shares outstanding in the latest quarter and 25.9 million a year earlier. Research and development expenses increased 23% to $3.1 million, driven by higher consulting costs, compensation expenses and stock-based compensation, partially offset by lower clinical trial expenses. Selling, general and administrative expenses rose 3% to $22 million, primarily due to increased compensation and stock-based compensation, partly offset by lower consulting and advertising costs. Interest expense increased by $94,000 to $1.6 million, which Oasheim said was driven by increased borrowings under the company’s term loan agreement with Innovatus Capital Partners. Other income, net, was $0.6 million, down from $1.1 million, primarily due to a lower cash balance. As of March 31, CVRx had $72.3 million in cash and cash equivalents. Net cash used in operating and investing activities was $12.3 million, compared with $12.9 million in the prior-year period. Hykes said the transition to Category I CPT codes, which took effect Jan. 1, represented “the most significant reimbursement advancement” in the company’s history. The 30-day Medicare Advantage prior authorization approval rate for submissions managed by CVRx’s in-house market access team was 46% in the first quarter, compared with 31% in 2024 and 44% in 2025. Within the quarter, Hykes said the approval rate was 50% through the first two months before declining in March. He attributed the March softening to changes in the broader reimbursement environment affecting the medical device industry, rather than to a change in the clinical or coverage rationale for Barostim. Hykes said new regulations requiring Medicare Advantage payers to respond to prior authorization requests within three or seven days, depending on urgency, led some payers to implement automated review processes beginning in late February. That resulted in more initial denials, often based on an experimental designation, even for therapies with Category I codes and clinical evidence. “We believe that this is simply a timing issue and not a change to the ultimate approval rates because when our market access team appeals these decisions with additional clinical documentation, most of the initial denials are overturned successfully,” Hykes said. During the question-and-answer portion of the call, Hykes said the company has begun using its own artificial intelligence tools to ensure prior authorization requests are complete and to respond to automated payer reviews. He said CVRx does not expect to expand its market access team to handle the increased initial denials. CVRx also highlighted progress on BENEFIT-HF, a randomized controlled trial evaluating Barostim in a broader heart failure population with ejection fraction up to 50% and NT-proBNP levels up to 5,000. Hykes said CVRx activated the first trial site in the first quarter and enrolled its first patient last week. He said feedback from the heart failure community has been positive and that the trial is also generating engagement from centers interacting with CVRx for the first time. If successful, Hykes said the trial could expand the company’s prevalence-based addressable market from approximately 339,000 patients to more than 980,000 patients, tripling the market opportunity to about $30 billion. Oasheim said CVRx is being cautious about expectations for trial site activation in 2026. He said it could take 12 to 24 months to reach the target of 150 activated sites. In response to another analyst question, Oasheim said the company has described the trial timeline as five to seven years, including a two-year follow-up period after full enrollment. CVRx reiterated its full-year 2026 revenue guidance of $63 million to $67 million. The company now expects full-year gross margin of 85% to 87% and continues to expect operating expenses of $103 million to $107 million. For the second quarter, CVRx expects total revenue of $15.1 million to $16.1 million. Oasheim said the company did not want to get ahead of itself by raising full-year revenue guidance after one quarter, despite the first-quarter outperformance. He said the guidance assumes prior authorization approval rates that are broadly consistent with 2025 levels, rather than assuming a benefit from Category I CPT codes. “We’re really happy with the results of seeing that re-acceleration get back to 20% growth, but just don’t want to get ahead of ourselves by updating guide too early in the year,” Oasheim said. CVRx, Inc 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "CVRx Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.