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CVRX

CVRxF
Nasdaq / Health Care Equipment & Services
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2026-06-02
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2026-05-15
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Earnings documents stored for CVRX.

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Investor releaseQuarter not tagged2026-05-15

Analysts Have Made A Financial Statement On CVRx, Inc.'s (NASDAQ:CVRX) First-Quarter Report

Simply Wall St.

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, whil...

Investor releaseQuarter not tagged2026-05-12

CVRx Q1 Earnings Call Highlights

MarketBeat

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 G...

Investor releaseQuarter not tagged2026-05-12

CVRx: Q1 Earnings Snapshot

Associated Press

MINNEAPOLIS (AP) — MINNEAPOLIS (AP) — CVRx Inc. (CVRX) on Monday reported a loss of $13.1 million in its first quarter. On a per-share basis, the Minneapolis-based company said it had a loss of 50 cents. The results exceeded Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 51 cents per share. The medical device company posted revenue of $14.8 million in the period, also exceeding Street forecasts. Three analysts surveyed by Zacks expected $14.2 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CVRX at https://www.zacks.com/ap/CVRX

Investor releaseQuarter not tagged2026-05-12

CVRx Reports First Quarter 2026 Financial and Operating Results

GlobeNewswire

MINNEAPOLIS, May 11, 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 first quarter of 2026. Recent Highlights Total revenue for the first quarter of 2026 was $14.8 million, an increase of approximately 20% over the prior year quarter U.S. revenue for the first quarter of 2026 was $13.7 million, an increase of 22% over the prior year quarter Active implanting centers in the U.S. grew to 257 as of March 31, 2026, as compared to 227 as of March 31, 2025 First site activated and first patient enrolled in BENEFIT-HF clinical trial "We delivered a strong start to 2026, with U.S. revenue growing 22% as the investments we made in our team and programs throughout 2025 begin to translate into results," said Kevin Hykes, President and Chief Executive Officer of CVRx. "We are seeing continued progress from our sales organization and the successful activation of the first site and our first patient enrolled in our BENEFIT-HF clinical trial. Together, these developments reinforce our confidence in the path ahead and in our ability to make Barostim more accessible to heart failure patients." First Quarter 2026 Financial and Operating Results Revenue was $14.8 million for the three months ended March 31, 2026, an increase of $2.4 million, or 20%, over the three months ended March 31, 2025. Revenue generated in the U.S. was $13.7 million for the three months ended March 31, 2026, an increase of $2.4 million, or 22%, over the three months ended March 31, 2025. Revenue units in the U.S. totaled 429 and 359 for the three months ended March 31, 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 March 31, 2026, the Company had a total of 257 active implanting centers in the U.S., as compared to 252 as of December 31, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. increased by three to a total of 56 during the three months e...

Investor releaseQuarter not tagged2026-05-12

CVRx Inc (CVRX) Q1 2026 Earnings Call Highlights: Strong U.S. Growth and Market Expansion Potential

GuruFocus.com

This article first appeared on GuruFocus. Release Date: May 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. CVRx Inc (NASDAQ:CVRX) exceeded the high end of their guidance range with a 22% growth in the United States. The transition to Category 1 CPT codes has significantly advanced reimbursement, with a 46% approval rate for Medicare Advantage prior authorizations in Q1 2026. The BENEFIT-HF trial, if successful, could expand the addressable market from 339,000 to over 980,000 patients, potentially tripling the market opportunity to $30 billion. Gross margin increased to 87% from 84% a year ago, driven by higher average selling prices and improved manufacturing efficiencies. The company has made meaningful progress in therapy awareness and clinical evidence, with a strong presence at cardiology meetings and the initiation of the BENEFIT-HF trial. The reimbursement environment faced challenges with new regulations causing higher initial denial rates, particularly in March. Revenue generated in Europe decreased by 2%, with a decline in revenue units from 59 to 56. Net loss for Q1 2026 was $13.1 million, slightly improved from a $13.8 million loss in Q1 2025, but still significant. R&D expenses increased by 23% to $3.1 million, driven by higher consulting and compensation expenses. The company is cautious about the timeline for the BENEFIT-HF trial, which could take 5-7 years to complete, delaying potential market expansion. Warning! GuruFocus has detected 3 Warning Signs with CVRX. Is CVRX fairly valued? Test your thesis with our free DCF calculator. Q: Can you elaborate on the dip in prior authorization approvals in March and how you plan to address it? Also, how does this impact your 2026 guidance? A: Kevin Hykes, CEO: The dip was due to new federal regulations leading to increased initial denials. We are using AI tools to ensure complete prior authorization requests to counter this. We believe this is a temporary issue and expect approval rates to remain strong. Jared Oshine, CFO: We assumed consistent approval rates in our 2026 guidance, and current rates are slightly better than last year, so we are confident in meeting our guidance. Q: How is the BENEFIT-HF trial progressing, and how does it impact your engagement with new centers? A: Kevin Hykes, CEO: The trial is a landmark for us, increasing...

TranscriptFY2026 Q12026-05-11

FY2026 Q1 earnings call transcript

Earnings source - 82 paragraphs
Operator

Reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Vallie from ICR Healthcare. Thank you. You may begin.

Mike Vallie

Good afternoon. Thank you for joining us today for CVRx's Q1 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 Q1 2026 earnings call. We delivered a strong start to 2026, exceeding the high end of our guidance range, driven by 22% growth in the United States. The investments we made throughout 2025 are beginning to positively impact our results. Last year, we worked deliberately to strengthen our sales organization, refine our go-to-market approach, advance critical reimbursement initiatives, and to secure approval for our landmark clinical trial. This quarter shows early evidence that the foundation we have built is translating into results. As we move through 2026, we remain focused on executing against the same three strategic priorities that have guided our work to date: building a world-class sales organization, driving deep adoption in targeted centers, and continuing to reduce the barriers to adoption of Barostim therapy.

Kevin Hykes

Starting with our sales organization, we're pleased with the progress we're seeing from the team. We're seeing meaningful contributions from a broader and more experienced sales team, reflecting the quality of talent we've been able to attract, the discipline we brought to onboarding and training, and the program-focused selling approach that the team is increasingly comfortable executing. We continue to expand both our active implanting center base and our territory footprint during the quarter, and we expect to maintain this cadence of expansion through the balance of the year. Our second priority is driving deep adoption in the centers we've targeted. Our program-focused playbook emphasizes intentional targeting, building a redundant network of clinical and administrative stakeholders, and establishing a defined Barostim workflow.

Kevin Hykes

In the accounts where all of these elements are in place, we're seeing Barostim becoming part of how heart failure is routinely managed rather than an episodic consideration, resulting in higher utilization. This remains the foundation for the long-term growth of our business. Our third priority is continuing to address the three fundamental barriers to the adoption of Barostim therapy: patient access, therapy awareness, and clinical evidence. We made meaningful progress on all three fronts in the Q1. Starting with patient access, the transition to Category I CPT codes, which took effect on January first, is the most significant reimbursement advancement in our company's history, and we're already beginning to see its impact.

Kevin Hykes

Our 30-day Medicare Advantage prior authorization approval rate for submissions managed by our in-house market access team was 46% for the Q1 of 2026 as compared to 31% in 2024 and 44% in 2025. Within the quarter, our approval rate was 50% through the first two months before declining in March. While we are encouraged by the underlying year-over-year improvement tied to the new Category I code, the March softening reflects the impact of simultaneous changes in the broader reimbursement environment that are affecting our company and others across the medical device industry. Effective January 1st, new regulations require Medicare Advantage payers to respond with a decision to a prior authorization request within 3 or 7 days, depending on urgency, as compared to the previous 14-day requirement.

Kevin Hykes

As a result, certain payers implemented new automated review processes beginning in late February in response to these compressed timeline requirements. This has resulted in a higher rate of initial denials, particularly in March, on the basis of an experimental designation, even for therapies with established Category I codes and well-documented clinical evidence. Importantly, this is not a reflection of a change in the clinical or coverage rationale for Barostim. This is a new administrative dynamic that is being seen broadly across the device industry, which is not unique to our therapy. 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.

Kevin Hykes

While the underlying coverage position for Barostim has never been stronger, our goal is to adapt to this changing environment and to ensure that every submission meets this increasing administrative scrutiny on the front end. Our market access team is implementing this approach with patients and providers through our in-house prior authorization service, as well as supporting physician practices with their independent prior authorization efforts to ensure that they effectively navigate this changing environment. We believe the long-term trajectory for patient access remains strongly positive, and we expect these payer processes to continue to normalize as the industry adjusts to the new regulatory framework. As it relates to therapy awareness. We continued to expand our medical education efforts during the quarter with a particular focus on the advanced practice providers who manage most of our indicated heart failure patients in the community.

Kevin Hykes

We also had a meaningful presence at several important cardiology meetings during the quarter, including multiple presentations at the THT and ACC meetings that reflect the growing body of clinical evidence supporting Barostim. These engagements continue to drive strong interest in Barostim therapy among the clinicians who are best positioned to identify candidates for treatment. Additionally, shortly after the Q1, we piloted our first educational symposium focused on nurses in community cardiology practices, extending our outreach beyond advanced practice providers to the registered nurse coordinators who also play a key role in managing heart failure patients in the community. In terms of clinical evidence, the recently initiated BENEFIT-HF trial is a landmark randomized controlled trial evaluating Barostim in an expanded population of heart failure patients with ejection fraction up to 50% and NT-proBNP levels up to 5,000.

Kevin Hykes

If successful, this trial would expand our prevalence-based addressable market from approximately 339,000 patients today to over 980,000 patients, effectively tripling our market opportunity to approximately $30 billion. I'm pleased to share that we activated the first site in our BENEFIT-HF trial in the Q1 and enrolled our first patient last week. The feedback from the heart failure community on the rigor and scale of the trial design has been very positive. Beyond the clinical objectives of the trial, we're seeing meaningful engagement from centers that are interacting with us for the first time because of BENEFIT-HF, which we believe will contribute to broader awareness and visibility for Barostim therapy. To wrap up, the Q1 reflects positive momentum across every part of our business.

Kevin Hykes

Our sales team is executing, the reimbursement environment is improving, and our clinical evidence program is advancing on schedule. We remain focused on continuing to execute through the balance of 2026, and we're confident in the path ahead. Now, I'd like to turn the call over to Jared for a financial review.

Jared Oasheim

Thanks, Kevin. Unless otherwise stated, year-over-year comparisons are for the three months ended March 31st, 2026, compared to the three months ended March 31st, 2025. In the Q1, total revenue generated was $14.8 million, an increase of $2.4 million or 20%. Revenue generated in the U.S. was $13.7 million, an increase of $2.5 million or 22%. Revenue units in the U.S. totaled 429 and 359 for the three months ended March 31st, 2026 and 2025, 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.

Jared Oasheim

We ended the quarter with a total of 257 active implanting centers as compared to 252 as of December 31, 2025. We had 56 sales territories in the U.S. at the end of the quarter compared to 53 at the end of 2025 and 45 on March 31, 2025. Revenue generated in Europe was $1.1 million, a decrease of $27,000 or 2%. Total revenue units in Europe decreased to 56 from 59 in the prior year period. The number of sales territories in Europe remained consistent at five. Gross profit was $12.9 million for the three months ended March 31, 2026, an increase of $2.6 million or 25%. Gross margin increased to 87% compared to 84% a year ago.

Jared Oasheim

Gross margin 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 23% to $3.1 million compared to the prior year period. This change was driven by an increase in consulting expenses, compensation expenses, and non-cash stock-based compensation expenses, partially offset by a decrease in clinical trial expenses. SG&A expenses increased $0.7 million or 3% to $22 million compared to the prior year period. This change was primarily driven by an increase in compensation expenses and non-cash stock-based compensation expenses, partially offset by a decrease in consulting expenses and advertising expenses. Interest expense increased $94,000 to $1.6 million compared to a year ago.

Jared Oasheim

This increase was driven by the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income net was $0.6 million compared to $1.1 million. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $13.1 million or $0.50 per share for the Q1 of 2026, compared to a net loss of $13.8 million or $0.53 per share for the Q1 of 2025. Net loss per share was based on 26.4 million weighted average shares outstanding for the Q1 of 2026 and 25.9 million weighted average shares outstanding for the Q1 of 2025.

Jared Oasheim

As of March 31st, 2026, cash and cash equivalents were $72.3 million. Net cash used in operating and investing activities was $12.3 million for the three months ended March 31st, 2026, as compared to $12.9 million for the three months ended March 31st, 2025. Turning to guidance. For the full year of 2026, we continue to expect total revenue between $63 million and $67 million. We now expect full year gross margin between 85% and 87%. We continue to expect operating expenses to be between $103 million and $107 million. For the Q2 of 2026, we expect to report total revenue between $15.1 million and $16.1 million. I'll now turn the call back over to Kevin for closing remarks.

Kevin Hykes

Thank you, Jared. The Q1 reflects a strong start to the year and gives us confidence in the path ahead. Our sales organization is maturing, the reimbursement environment is improving, and the initiation of BENEFIT-HF opens a meaningful new chapter for our company and for the heart failure patients that we serve. We have more work to do, and we remain focused on execution as we continue to advance Barostim toward becoming a standard of care for the treatment of heart failure. Now, I'd like to open the line for questions. Operator?

Operator

Thank 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 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 pull for questions. The first question is from Brandon Vazquez from William Blair. Please go ahead.

Speaker 9

Hey, guys. It's Max on for Brandon. Thanks for taking the questions. Kevin, I just wanted to start with one on the prior authorization stuff. I understand that the dip in March was due to some of the automation that you mentioned. Can you just touch on how some of the practices you guys have put into place to address this have trended thus far and higher level, what, you know, what's included in 2026 guidance for, you know, any potential ongoing headwinds in that case?

Kevin Hykes

Sure. Thanks. Appreciate the question, Max. I'll let Jared address the guidance piece, but upfront as I mentioned, this was an unexpected and inadvertent effect of some new federal regulations that went into place on January 1st. We first saw this in late February, and what we saw was an increase in kind of immediate denials, often for, again, experimental reasons, but in fact because of administrative gaps in the prior authorizations or effectively, missing signatures, or they're using AI, as we can best tell, to find any missing data they possibly can to serve as a grounds for immediately denying a prior authorization request, which then buys them the additional time they now need under the new rules to properly evaluate. We have responded, working closely.

Kevin Hykes

You know, obviously, we have an in-house team that does this day in and day out. We have lots of physicians who do it themselves, but have begun using our own AI tools to ensure that every possible T is crossed and I is dotted in these very lengthy prior authorization requests so that we can defeat this attempt to buy time, which is what we believe it effectively is. Importantly, what we are seeing, and this has been corroborated with partners across the industry through the back channels, we see a very healthy overturn rate. We think this is really, if it is a surprise, it is that these are taking a little longer than we thought they would. The ultimate approval rates we think will be as good or better as the prior chapter under Category III.

Kevin Hykes

I think it's a temporary situation. We're all working our way through it. I think it's something that will not affect ultimately the approval rates for the therapy. Jared, do you want to cover the second part of the question?

Jared Oasheim

Yeah, happy to. Max, just to clarify as well, you know, one of the things that we're watching really closely is that 30-day approval rate. You know, we just received that 30-day approval rate for March at the end of April, noting, you know, a slight decline from what we had seen in the January and February data. I just wanted to clarify that piece. As for the guidance, we didn't really know what was going to happen with Category I. We assumed it would lead to more or higher approval rates for our prior authorizations that we're supporting in 2026. We didn't want to bank on that as we were setting up the guidance for 2026.

Jared Oasheim

To hit the numbers that we had put in the initial guide, we assumed very consistent 30-day and 60-day approval rates for cases that required prior authorization support. I think Kevin mentioned it in the prepared remarks. Last year, we saw 30-day approval rates of roughly 44%. So far in Q1, we're at 46, so doing slightly better year to date. If that continues, then we shouldn't see any issues as far as hitting the guide that we had initially set. Although I'll just add, Kevin mentioned longer term, we're still expecting this to just be a timing issue. We do expect the appeals approval rate to be greater for these Category 1 cases as the documentation is refined.

Jared Oasheim

We still expect there to be a greater final or terminal approval rate for these prior authorizations under Category I, but we're not gonna bake that into guidance until we actually see it play through, play out.

Speaker 9

That's helpful. Then just for a follow-up, you know, congrats on enrolling the first patient, BENEFIT-HF. How should we think about that progressing as the year moves on? Kevin, I believe you mentioned in your prepared remarks that it was helping you guys get your foot in the door with some new centers that may not have been familiar with Barostim. Can you just talk to us about that dynamic specifically and then broader, how we should think about the ramp of the trial throughout the rest of the year? Thanks.

Kevin Hykes

Sure. I'll maybe cover the second part first and let Jared cover your initial question. You know, as we've mentioned, this is a landmark trial in heart failure. It's a landmark trial for our company, the largest, we believe, therapeutic device trial ever done. You know, there's kind of two ways to think about it. If you think about the barriers to the adoption of therapy, which are awareness, evidence, and patient access, this trial touches on all three of those, and it's driven significant awareness for us. It will be a foundational element of our long-term evidence portfolio. Number three, the Category B designation effectively creates a National Coverage Determination for patients enrolled in this trial, and that's a population that's three times bigger than our current population.

Kevin Hykes

It sort of checks all three boxes in terms of helping us further reduce barriers. On a more practical level, it is indeed for those ultra-conservative centers that perhaps haven't yet been ready to adopt Barostim, it is an excellent engagement tool, and many of them are, in fact, willing to implant Barostim under the auspices of a trial like this. For those that have already adopted Barostim, it's an equally interesting engagement tool because it allows them to treat many, many more patients, often patients they're turning away for Barostim today. I think there are a number of different tailwinds.

Kevin Hykes

We've not necessarily baked those into our data yet, but we think it and have already seen evidence that this is seen as a leadership confidence-boosting signal from the company and a, and a project that many of our physicians want to be part of.

Jared Oasheim

Max, to address the ramp question. We are really happy to see the first couple of sites activated, that first patient enrolled in the trial so early in the year. We are still being a little cautious as far as what we are going to bake into expectations for 2026. We are going to need a little bit more experience with our site activation process before we start setting expectations on how many new sites could be activated each month and therefore by the end of this year. You know, we are starting to think about this in terms of, you know, multiple quarters, maybe multiple years to get all of these sites up and running.

Jared Oasheim

You know, it could take 12-24 months to get to that target of 150 sites activated and fully starting to enroll this trial.

Speaker 9

That's helpful. Thanks, guys.

Jared Oasheim

Yep.

Operator

The next question is from Jon Young from Canaccord Genuity. Please go ahead.

Jon Young

Hey, Kevin and Jared. Thanks for taking the question. Congratulations on the quarter. I just wanted to start off on the reiteration of the revenue guidance. You guys had a solid Q1 beat, I'm wondering, the reiteration itself, is that just Q1 conservatism or are you seeing anything maybe beyond the reimbursement dynamics that you already highlighted as we sit here in May?

Jared Oasheim

Yeah, happy to take that one, Jon. Yeah, I mean, one quarter in at this point, this is a year where we are re-accelerating our growth rate after doing a lot of team building and rebuilding kind of the ground floor of the company over the last couple of years. We just simply didn't wanna get ahead of ourselves from a guide perspective with updating the full year number after just the Q1. You know, we're really happy with the results of seeing that re-acceleration get back to 20% growth, but just don't wanna get ahead of ourselves by updating guide too early in the year.

Jon Young

Great. Thanks, Jared. You know, to also just touch on the MA prior authorization. You know, when they get close to 50%, can you just remind us again of willingness of, you know, MA payers to create policies? Can you also remind us again, do you need prior authorization for patients enrolled in BENEFIT-HF?

Kevin Hykes

Sure. Thanks, Jon. I'll take the second one first. The short answer is no, we don't, which is obviously a benefit. Patients that are eligible and enrolled in the trial will be treated almost as traditional Medicare patients. No prior authorization required. That's a positive. You know, as it relates to the first question, can you remind me?

Jared Oasheim

Yeah, yeah. If you get greater than a 50% approval rate.

Kevin Hykes

Yes. Thank you.

Jared Oasheim

Yep.

Kevin Hykes

No, Jon, the way this worked, and we've described it sort of as a war of attrition. Effectively, you know, roughly 10% of all denials are ever appealed. Those that are appealed across the spectrum, 80%+ of them are ultimately approved. It's really about not giving up and being tenacious in the way that we appeal each and every denial. The number we've quoted, if you push it all the way to the end of the process, which is the administrative law judge review, the industry data would suggest once the payers begin losing not even 50% of those, for high 40 percentages, they will then begin to approve without having to go to ALJ because the ALJ process is expensive, and they bear that cost. That's maybe the number you're referring to.

Kevin Hykes

It's about 48% from what we understand.

Jon Young

Just to follow up on that, Kevin, is there any expectations on your end of when we could approach that number?

Kevin Hykes

You know, we are starting to see we're in that neighborhood with a number of payers already. I guess I didn't answer the part of your question. Once you cross that threshold, you then ideally move into a situation where you often have silent coverage. They don't yet have a written policy, but they are, in fact, approving. Eventually then you move on to a written coverage policy through a number of different mechanisms. That's still some years away.

Kevin Hykes

We're pleased with what we're seeing as we move through this process, and we're pleased with the number of these administrative law appeals that we ultimately win.

Jon Young

Great. Thank you.

Operator

The next question is from Matt O'Brien from Piper Sandler. Please go ahead.

Speaker 8

Hi, this is Sam on for Matt. Thank you so much for taking our question. I guess first we just wanted to touch on the ASP in the quarter, which looks really nice. You know, which, it's a little bit different than historical seasonality, where we see a dip in Q1. Can you talk about your expectations for ASP the rest of the year? You know, is this related to the Category I code? Any other details there would be great.

Jared Oasheim

Yeah, happy to take that one, Sam. You know, I think we're seeing close to $32,000 ASPs on the U.S. business for the Q1. A nice step up again from the average that we saw in 2025, closer to $31,500. I'm still a little reluctant to bake that into expectations throughout 2026 at this point in time, kind of expecting that number to be around $31,000 or maybe $31,500 throughout the year. We are incentivizing the sales team to go out and capture as high of an ASP as possible. The team will continue to push on that to see that number potentially grow over time, just not baking that into expectations for 2026.

Speaker 8

Okay. That's helpful. Thank you. Also going back and touching on BENEFIT-HF, you know, how long do you anticipate this trial to enroll? Any expectations on ultimately when you think potentially the TAM could triple?

Jared Oasheim

Yeah. It's a good question. As we laid out this trial, we talked about a timeline of five to seven years, knowing that once we fully enroll the trial, there's gonna be a two-year follow-up period for that final patient. If we kinda hit the middle of that target, it would take about four years to enroll the 2,500 patients, and then two years afterwards to follow them up. You're talking six years from the beginning of the trial this year out into the early 2030s before we could potentially see that FDA approval.

Speaker 8

Got it. Thank you.

Operator

The next question is from Frank Takkinen from Lake Street Capital Markets. Please go ahead.

Frank Takkinen

Great. Thank you for taking the questions. I was hoping to start with a conversation around some higher utilization sites. I think previously you've spoke to top 20% of sites averaging in the neighborhood of 1.5 procedures per month. Can you maybe speak to that top 20% cohort, what their utilization rates are looking like today? Any commentary towards, kinda the opposite of that question of more sites graduating into that 1.5 per month rate?

Jared Oasheim

Yeah. Appreciate the question, Frank. We were trying to draw a line in the sand for investors and the outside community to understand what is possible with these centers. We pulled that as an ad hoc analysis in the Q4 for our top 20% of centers to note that they were doing more than one patient per center per month to show what is possible for these centers as we continue to build out our programs. I don't think it's gonna be a metric that we're gonna share on a quarterly basis because we do know that there is some seasonality that plays in as we look to the results from Q4 then going into Q1. Maybe on an annual basis, doing a reflection of how many more of those centers are now reaching that threshold of hitting one patient a month.

Jared Oasheim

maybe giving a refresh on that number in Q4 this year.

Frank Takkinen

Okay. Fair enough. I'll maybe try another one that you may be reluctant to answer. Can you speak to prior auth rates in April by chance? I'm just trying to understand if we had 50% in the first two months and then ended at 46%, I think that implies that March was maybe high thirties. Just curious if that was kinda up or down from that prior auth rate.

Jared Oasheim

Yeah. I don't think March was quite that bad, Frank. There is a little bit of just how many prior auths were being processed in the month of March compared to January and February. We did have a bit of a bolus coming through in the month of January that helped drive that rate a little bit higher. As for April, we are seeing it bounce back, but again, we don't have 30-day rates yet for the month of April. All we have is about 11 days worth of data for all of the prior authorizations that were submitted in the month of April at this point in time. What we are seeing in those early rates is seeing a little bit of a bounce back closer to the January, February approval rates than what we saw in the month of March.

Jared Oasheim

Again, we're expecting this to be a little bit of up and down as we implement new tools and other payers implement new tools to adapt to this new regulation that was issued at the beginning of the year. We are seeing it bounce back a little bit in the early data for the month of April.

Frank Takkinen

Got it. Okay. That is helpful. Thank you.

Operator

The next question is from Chase Knickerbocker from Craig-Hallum Capital Group. Please go ahead.

Chase Knickerbocker

Great. Thank you for taking the questions. Maybe just to follow up on a couple, on the dynamic here with Medicare Advantage. Can you just remind us, the mix, between Part B and Medicare Advantage as far as within your Medicare business?

Jared Oasheim

I think I can take that one, Frank. The traditional or sorry, Chase. I'm sorry. The traditional Medicare patients represent about a third of our overall patient population. Medicare Advantage patients represent another third. The remaining third of the patient population are private payers, VA, maybe uncovered patients included in that population. Two-thirds are covered by Medicare, but it's split 50/50 traditional Medicare and Medicare Advantage.

Chase Knickerbocker

That reflects your kinda current business mix?

Jared Oasheim

Yeah. I mean, yeah. We're basically in line, if not a little bit heavier-weighted towards these Medicare patients.

Chase Knickerbocker

Got it. Just to follow up on Frank's question, you know, your guidance assumes that kind of approval rate that you saw in 25. Can you know, just maybe speak to your comfortability? Is it what you've seen in April as far as kind of that, you know, rate in March kind of recovering? Did it really not impact revenue trajectory in March? Just maybe speak to kind of the comfortability around that trend.

Jared Oasheim

Yeah. Yeah. It's, it's the latter, Chase. Yeah. We're, we're feeling good about the guidance that we provided top line. We're at a point where we believe the MA approval rates at 30 days or even the terminal rates are gonna be as good or better than what we've seen in 2025. We wanna see this play out a little bit further before we would tighten the range on the guidance.

Chase Knickerbocker

Got it. Just last one from me. On, as we just think about, you know, July approaching and the OPPS proposed rule, have there been any conversations that are notable or, you know, any sort of, anything you can share as far as any conversations that have happened around, you know, your APC placement or any additional thoughts that you guys have there?

Kevin Hykes

Sure. Thanks, Chase. I'll take that one. It's time for Groundhog Day, I guess, again. The good news is we've been working on this as we have in past years since January, very constructive engagement with CMS. Our data is better than it's ever been, as is the combined data of this coalition of five companies. Importantly, all five companies this year are starting in 1580, which has not been the case in the past. We think that bodes well for this year's cycle, and we're hopeful that this will be the year that we can finally put this issue to bed. No, no specifics right now or commitments obviously from CMS, but lots and lots of engagement.

Chase Knickerbocker

Got it. Thank you.

Kevin Hykes

You bet.

Operator

The last question comes from Robbie Marcus from J.P. Morgan. Please go ahead.

Speaker 7

Hi, this is Alan on for Robbie. Thanks for the question. I just had a quick one on your expectations for center adds this year. I think you had previously talked to, you know, an average of, say, high single-digit centers per quarter. I think Q1 was, you know, relative to our expectations, a little bit on the lower side. I was curious about the commentary that you had said about the trials potentially, you know, bringing in new centers that, you know, hadn't historically been CVRx customers. You know, understanding that the onboarding process for these centers is, you know, a longer process, how should we think about that expectation for high single digits?

Speaker 7

Could there be, you know, potentially some upside pressure as, you know, some of these newer accounts are brought in through the trials rather than, you know, maybe your, you know, the standard base commercial efforts?

Jared Oasheim

Hi, Alan. Happy to take that question. Thank you. Our expectation is that the vast majority of the centers that will be activated in BENEFIT-HF will have experience with Barostim already. We don't believe that this is going to be a significant driver to the new center adds near term. Over time, as we engage some of those new centers, and they start to treat patients, they will be included in the active implanting center totals. I don't think that that's going to have an impact over the next few quarters throughout 2026. As far as expectations go for the new center adds on a quarterly basis, we are still setting the expectation for high single digits on a net basis on a quarter to quarter.

Jared Oasheim

We may see some variability like we did in the Q1, where we were +5 here in the Q1. Maybe 1 quarter we get to low double digits, other quarters, you know, we're hovering around five or six new center adds on a quarterly basis.

Speaker 7

Got it. Just a quick follow-up on the Medicare Advantage dynamic. When we think about, you know, having to have your market access team, you know, appeal these decisions and, you know, in light of your, I think, reiterated operating spend guidance, you know, does this factor in, you know, potentially having to expand that team to have to, you know, address this higher rate of denials, potentially invest a bit more to make sure that you are, you know, continuing to go on the offensive while also addressing these denials? Or is that something you think you can handle with your current team as is?

Kevin Hykes

Yeah. Thanks, Alan. That's a great question. The short answer is no, we do not. You know, we are deploying AI to respond to AI in effect, we don't believe that our team will be any less efficient or that the burden on them will change dramatically. We're sort of responding to a new tool or trick that's being deployed against us, and we're confident we can respond appropriately and that team can continue to support prior auths in roughly the same with the same efficiency that they have historically.

Operator

This concludes the question and answer session. I would like to turn the floor back over to Kevin Hykes for closing comments.

Kevin Hykes

Thank you, operator, and thanks to everyone for joining us today. We appreciate your continued support and look forward to updating you on our progress next quarter. Thank you.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Investor releaseQuarter not tagged2026-05-08

CVRx Inc (CVRX) Q1 2026 Earnings Report Preview: What To Look For

GuruFocus.com

This article first appeared on GuruFocus. CVRx Inc (NASDAQ:CVRX) is set to release its Q1 2026 earnings on May 11, 2026. The consensus estimate for Q1 2026 revenue is $14.48 million, and the earnings are expected to come in at -$0.52 per share. The full year 2026's revenue is expected to be $65.12 million and the earnings are expected to be -$1.99 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 2 Warning Signs with CVRX. Is CVRX fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for CVRx Inc (NASDAQ:CVRX) have increased from $64.66 million to $65.12 million for the full year 2026 and declined from $78.56 million to $75.97 million for 2027 over the past 90 days. Earnings estimates for CVRx Inc (NASDAQ:CVRX) have declined from -$1.95 per share to -$1.99 per share for the full year 2026 and declined from -$1.63 per share to -$1.86 per share for 2027 over the past 90 days. In the previous quarter of 2025-12-31, CVRx Inc's (NASDAQ:CVRX) actual revenue was $16.02 million, which beat analysts' revenue expectations of $15.82 million by 1.26%. CVRx Inc's (NASDAQ:CVRX) actual earnings were -$0.46 per share, which missed analysts' earnings expectations of -$0.44 per share by -4.78%. After releasing the results, CVRx Inc (NASDAQ:CVRX) was down by -13.01% in one day. Based on the one-year price targets offered by 5 analysts, the average target price for CVRx Inc (NASDAQ:CVRX) is $12.20 with a high estimate of $14.00 and a low estimate of $10.00. The average target implies an upside of 66.67% from the current price of $7.32. Based on GuruFocus estimates, the estimated GF Value for CVRx Inc (NASDAQ:CVRX) in one year is $16.02, suggesting an upside of 118.85% from the current price of $7.32. Based on the consensus recommendation from 7 brokerage firms, CVRx Inc's (NASDAQ:CVRX) average brokerage recommendation is currently 2.1, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-04-28

CVRx to Report First Quarter 2026 Financial and Operating Results and Host Conference Call on May 11, 2026

GlobeNewswire

MINNEAPOLIS, April 27, 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 that it plans to release first quarter 2026 financial and operating results after market close on Monday, May 11, 2026. The Company will host a conference call to review its results at 4:30 p.m. Eastern Time the same day. 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 for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact: Mark Klausner or Mike Vallie ICR Healthcare 443-213-0501 [email protected] Media Contact: Emily Meyers CVRx, Inc. 763-416-2853 [email protected]

Investor releaseQuarter not tagged2026-04-13

CVRx Reports Preliminary First Quarter 2026 Financial Results

GlobeNewswire

Delivered strong topline performance with first quarter revenue expected to be $14.7 million to $14.8 million, approximately 20% growth compared to first quarter of 2025 Early data in 2026 shows an increase in the 30-day approval rate for Medicare Advantage prior authorizations managed by our market access team First site activated in BENEFIT-HF clinical trial MINNEAPOLIS, April 13, 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 certain preliminary unaudited first quarter 2026 financial and operating results. "The investments we made in our team and programs in 2025 are beginning to pay off, allowing us to deliver strong revenue growth in the first quarter,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are also starting to observe positive effects from the Category I CPT Code that took effect at the beginning of the year, as early data shows improved 30-day prior authorization approval rates compared to what we saw in 2025. Our continued progress in reducing the barriers to adoption for Barostim have enabled us to start the year off with positive momentum, and we are excited about what that means for the balance of 2026 and beyond.” First Quarter 2026 Total revenue for the first quarter of 2026 is expected to be in the range of $14.7 million to $14.8 million compared to revenue for the first quarter of 2025 of $12.3 million, representing growth of approximately 20%. Gross margin for the first quarter of 2026 is expected to be approximately 87% compared to 84% in the first quarter of 2025. Total operating expenses for the first quarter of 2026 are expected to be approximately $25 million compared to $23.7 million in the first quarter of 2025. As of March 31, 2026, the Company had a total of 257 U.S. active implanting centers, as compared to 252 as of December 31, 2025. The number of sales territories in the U.S. increased by three to a total of 56 during the three months ended March 31, 2026. As of March 31, 2026, cash and cash equivalents were approximately $72.3 million. Reimbursement Update As previously disclosed, the Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using the Company’s Ba...

Investor releaseQuarter not tagged2026-02-16

CVRx Inc (CVRX) Q4 2025 Earnings Call Highlights: Revenue Growth and Strategic Expansions Amid ...

GuruFocus.com

This article first appeared on GuruFocus. Release Date: February 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. CVRx Inc (NASDAQ:CVRX) reported a 4% increase in fourth-quarter revenue to $16 million and a 10% increase in full-year revenue to $56.7 million. The company expanded its sales territories to 53 and increased active implanting centers to 252, reflecting a 10% and 13% growth, respectively. CVRx Inc (NASDAQ:CVRX) achieved a gross margin increase to 86% from 83% due to higher average selling prices and improved manufacturing efficiencies. The transition to Category 1 CPT codes is expected to improve patient access and reimbursement predictability, reducing prior authorization denials. The initiation of the Benefit HF trial, a large-scale study, could potentially triple the addressable market to $30 billion if successful. Net loss increased to $11.9 million in Q4 2025 from $10.7 million in Q4 2024, indicating ongoing financial challenges. The sequential growth in active accounts was lower than expected, reflecting potential challenges in sales strategy execution. R&D and SG&A expenses increased by 7% and 9%, respectively, driven by higher compensation and advertising costs. The company is still in transition with the new Category 1 CPT codes, and it may take several quarters to fully realize the benefits. Despite improvements, the Medicare Advantage prior authorization approval rate was only 46% in 2025, indicating room for further improvement. Warning! GuruFocus has detected 2 Warning Sign with CVRX. Is CVRX fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the initial sites for the Benefit HF trial and whether they will be new or existing commercial sites? Will there be any revenue generation from these cases? A: (Kevin Hikes, CEO) We are early in the recruitment of centers, aiming for about 150 in the US and a few in Germany. There will be a mix of centers already using Barostim and some new to commercial implantation. (Jared Osheine, CFO) The trial is set for 2,500 randomizations, with 2/3 requiring an implant. We expect reimbursement from Medicare or Medicare Advantage plans, leading to sales of around 1,600 to 1,700 devices. Q: How should we expect the growth of active accounts to trend through 2026? A: (Jared Osheine, CFO) We plan to add around 3 active...

Investor releaseQuarter not tagged2026-02-15

Analysts Are Updating Their CVRx, Inc. (NASDAQ:CVRX) Estimates After Its Full-Year Results

Simply Wall St.

There's been a major selloff in CVRx, Inc. (NASDAQ:CVRX) shares in the week since it released its full-year report, with the stock down 24% to US$4.95. The results overall were pretty much dead in line with analyst forecasts; revenues were US$57m and statutory losses were US$2.04 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. With this in mind, we've gathered the latest statutory forecasts to see what the analysts are expecting 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 consensus forecast from CVRx's seven analysts is for revenues of US$64.9m in 2026. This reflects a meaningful 15% improvement in revenue compared to the last 12 months. Losses are expected to hold steady at around US$2.03. Yet prior to the latest earnings, the analysts had been forecasting revenues of US$64.7m and losses of US$1.95 per share in 2026. So it's pretty clear consensus is mixed on CVRx after the new consensus numbers; while the analysts held their revenue numbers steady, they also administered a pronounced increase to per-share loss expectations. View our latest analysis for CVRx As a result, there was no major change to the consensus price target of US$11.17, with the analysts implicitly confirming that the business looks to be performing in line with expectations, despite higher forecast losses. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. 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. This is a fairly broad spread of estimates, suggesting that analysts are forecasting a wide range of possible outcomes for the business. One way to get more context on these forecasts is to look at how they compare to both past performance, and how other companies in the same industry are performing. We would highlight that CVRx's revenue growth is expected to slow, with the forecast 1...

Investor releaseQuarter not tagged2026-02-13

CVRx: Q4 Earnings Snapshot

Associated Press Finance

MINNEAPOLIS (AP) — MINNEAPOLIS (AP) — CVRx Inc. (CVRX) on Thursday reported a loss of $11.9 million in its fourth quarter. The Minneapolis-based company said it had a loss of 46 cents per share. The results missed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 42 cents per share. The medical device company posted revenue of $16 million in the period. For the year, the company reported a loss of $53.3 million, or $2.04 per share. Revenue was reported as $56.7 million. For the current quarter ending in March, CVRx said it expects revenue in the range of $13.7 million to $14.7 million. The company expects full-year revenue in the range of $63 million to $67 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CVRX at https://www.zacks.com/ap/CVRX

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook