CVRx (CVRX) Q4 2025 Earnings Call Transcript

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Date

Thursday, Feb. 12, 2026 at 4:30 p.m. ET

Call participants

• President and Chief Executive Officer — Kevin Hykes
• Chief Financial Officer — Jared Oasheim

Takeaways

• Revenue -- $16 million for the quarter, representing a 4% increase, with U.S. revenue at $14.9 million and European revenue at $1.1 million (up 10%).
• Gross profit and margin -- $13.8 million gross profit, up 8%; gross margin improved to 86% from 83% due to higher average selling price and manufacturing efficiencies.
• Net loss -- $11.9 million, or $0.46 per share, compared to $10.7 million, or $0.43 per share, with 26.2 million weighted-average shares outstanding.
• Cash position -- $75.7 million in cash and equivalents at year-end; $10 million borrowed in January increases total principal outstanding to $60 million under the amended debt facility.
• Product adoption metrics -- 478 revenue units in the U.S. (up from 404), and 49 in Europe; 252 active implanting centers (13% increase) and 53 U.S. sales territories (10% increase) at year-end.
• Operating expenses -- R&D expenses totaled $3 million (up 7%); SG&A reached $22 million (up 9%), driven mostly by increased headcount and advertising.
• BENEFIT HF clinical trial -- Initiation announced for a 2,500-patient U.S./Germany trial, with CMS coverage and an estimated $20 million–$30 million cash impact over 5–7 years; the trial could triple the addressable market to $30 billion if successful.
• Reimbursement milestone -- Category I CPT codes effective Jan. 1, 2026, with national average implanting physician payment approximately $560; expected to improve reimbursement predictability and reduce prior authorization denials.
• Medicare Advantage approval rate -- 46% approval rate for 30-day prior authorization, up from 31%.
• 2026 guidance -- Revenue expected between $63 million and $67 million; gross margin guidance 84%-86%; operating expenses projected at $103 million–$107 million; Q1 revenue outlook $13.7 million–$14.7 million.
• Sales strategy -- Focus on deepening adoption at high-potential accounts, with the top 20% of centers averaging 19 implants per year and about 300 indicated patients per center.
• Debt facility amendment -- Extended debt maturity to 2031, with access to an additional $40 million contingent on milestone achievement.
• Leadership update -- Greg Morrison appointed Chief Human Resources Officer effective March, succeeding Tanya Austin.
• Cash burn and liquidity -- Cash used in operating and investing activities was $40.8 million, with at least two years of cash and $40 million more available debt based on future revenue milestones.

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Risks

• The net loss increased to $11.9 million from $10.7 million as expenses rose faster than revenue.
• The quarterly sequential increase in active implanting centers was minimal (from 250 to 252), with management noting account closures impacted growth.
• Management expects a seasonal revenue dip from Q4 to Q1 before sequential growth resumes.

Summary

CVRx (NASDAQ:CVRX) reported quarterly revenue growth and expansion in gross margin, supported by wider U.S. and European adoption and higher average selling prices. The company has initiated the pivotal BENEFIT HF trial, which could significantly expand its addressable market if successful, with coverage secured for the trial and Medicare reimbursement for enrolled patients. Category I CPT code implementation is expected to improve reimbursement and reduce friction in patient access, while improvements in the salesforce and targeted account strategy provide the foundation for guided revenue acceleration in 2026.

• Management described early evidence of improved Medicare Advantage approval rates and initial positive impacts from Category I CPT code changes on payer behavior.
• The company plans to add three new U.S. sales territories per quarter in 2026, with expected high single-digit increases in active implanting centers each quarter on a net basis.
• Top-performing accounts demonstrated the importance of multi-stakeholder engagement, administrative support, and redundancy among prescribers and implanters for consistent high implant rates.
• Approximately 1,600–1,700 devices are expected to be sold into the BENEFIT HF trial, providing device revenue from trial enrollments reimbursed at commercial rates.
• SG&A growth continues to outpace revenue, contributing to a persistent net loss despite ample liquidity and capital access.

Industry glossary

• Barostim: CVRx’s neuromodulation implantable device designed to improve symptoms in patients with heart failure with reduced ejection fraction (HFrEF).
• Category I CPT code: A permanent, standard reimbursement code in the U.S. medical billing system, replacing a temporary Category III code and increasing reimbursement predictability for medical procedures.
• BENEFIT HF trial: CVRx’s large, randomized controlled trial for Barostim, intended to demonstrate impact on mortality and heart failure events in an expanded patient population.
• CMS Category B IDE coverage: U.S. Medicare policy allowing reimbursement for patients and facilities participating in specified medical device clinical trials.
• APPs: Advanced Practice Providers including nurse practitioners and physician assistants who often deliver direct care and referrals in cardiology practice.

Full Conference Call Transcript

Kevin Hykes. Thanks, Mike. Good afternoon, and thank you for joining us for our fourth quarter and full year 2025 earnings call. We delivered fourth quarter revenue of $16,000,000 and full year revenue of $56,700,000, representing growth of 410%, respectively. 2025 was a year of important and necessary investment in our commercial foundation. We strengthened our sales organization, refined our go-to-market approach, and advanced critical initiatives that position us for growth ahead. As we reflect on the year, it is important to remember what drives our work. Heart failure affects 6.7 million Americans, many of whom remain symptomatic despite optimal medical therapy.

These patients, often referred to as the walking wounded in the heart failure community, suffer with significantly diminished quality of life, including limited mobility, chronic fatigue, and the inability to perform basic daily activities.

Operator: While guideline-directed medical therapy has demonstrated survival benefits,

Kevin Hykes: when taken compliantly, it does very little to improve how patients actually feel on a day-to-day basis.

Operator: In fact,

Kevin Hykes: multiple studies in this population have consistently shown that these patients would trade longevity for better quality of life. They do not want to simply live longer, they want to live better. To play with their grandchildren, to walk their dog, and to maintain their independence. Barostim addresses this critical unmet need. Unlike medications that primarily target survival, it demonstrably improves exercise capacity and quality of life, giving patients back the ability to engage in the activities that matter most to them. When we talk about our market opportunity, it is important to consider our indicated population not just in terms of the annual incidence, but also the prevalence pool.

While approximately 76,000 patients are newly diagnosed each year and enter our indication,

Operator: heart failure is a chronic disease state.

Kevin Hykes: Patients are not only eligible for Barostim therapy in the year that they are diagnosed. They can live four, five, or six years within our indication as their disease progresses, and benefit from treatment throughout that time. When considered on this prevalence basis, there are 339,000 patients today who are indicated and who could benefit from Barostim therapy, representing a $10,500,000,000 market opportunity that remains well less than 1% penetrated. Our focus remains on making this therapy widely available to all patients who can benefit.

Operator: In 2025, we built

Kevin Hykes: the foundation necessary to reach more of these patients by executing on our three strategic priorities: building a world-class sales organization, driving deep adoption in targeted centers, and reducing the barriers to adoption. Starting with our progress on the sales force, we undertook a deliberate transformation of our commercial organization to build the right team for our next phase of growth. We are pleased with the quality of talent that we have attracted and the progress that we are seeing in their development. By year-end, we had expanded to 53 territories with 252 active implanting centers, up 10% and 13%, respectively. This expansion positions us with the capacity to drive meaningfully higher growth as our reps mature.

While integrating these many new representatives has created some near-term impact on growth, we are increasingly confident in the team's ability to execute our program-focused selling approach as they gain experience. We have also implemented several important changes to accelerate the productivity of our sales team. We have optimized our field leadership structure, added dedicated training resources, and focused our representatives on a narrower set of high-potential accounts, typically three to five, where they can drive deep adoption and truly change clinical behavior. Our second priority is creating sustainable Barostim programs that demonstrate deep adoption and consistent utilization. We are starting to see the validation of this approach, as evidenced by higher and more consistent utilization at the account level.

The path to creating a sustainable program starts with the intentional targeting of high-potential centers. This is followed by the development of an aligned and redundant stakeholder network that includes not just a clinical champion, but administrative support, multiple prescribers, and multiple implanters. The final necessary element is a defined Barostim workflow that ensures effective and efficient patient identification, referral, screening, and implantation. Where we see these three elements in place, we see deeper adoption and consistent utilization, creating a flywheel effect. Barostim becomes part of how heart failure is routinely managed, rather than an episodic consideration. Importantly, in the accounts where this flywheel effect is beginning to take hold, we are seeing significant additional runway for much deeper penetration.

For example, the top 20% of centers had an annualized implant rate of about 19 implants in Q4. We believe each of these top centers has approximately 300 patients who are currently indicated for the therapy.

Operator: This demonstrates the substantial opportunity

Kevin Hykes: that we have through continued program development in our existing account base. Our third priority is our continuing focus on addressing the three fundamental barriers to the adoption of Barostim therapy.

Operator: Patient access, therapy awareness,

Kevin Hykes: and clinical evidence.

Operator: As it relates to patient access,

Kevin Hykes: the most significant and impactful development is our transition to Category I CPT codes, which took effect on 01/01/2026. This major milestone is an important validation of Barostim therapy from the perspective of physicians, hospitals, and payers. The Category I code will improve patient access by eliminating the automatic prior authorization denials associated with Category III codes, improving reimbursement predictability, and formalizing the implanting physician payment at a national average of approximately $560. We believe that this change will meaningfully reduce friction in the prior authorization process going forward. We are also seeing encouraging progress in our ongoing efforts to improve coverage. Our 30-day Medicare Advantage prior authorization approval rate reached 46% in 2025, up from 31% in 2024.

This represented remarkable progress for a therapy with a Category III code, and with the Category I code now in effect, we are optimistic that these approval rates will continue to improve. On the awareness front, we significantly expanded our medical education programs in 2025. We completed over 150 local, regional, and national educational events targeting physicians and advanced practice providers who manage heart failure patients in the community. Our focus on APPs, the nurse practitioners and physician assistants who see these patients far more frequently than physicians, has become a key leverage point in building sustainable referral networks around our targeted centers.

Finally, regarding clinical evidence, we recently announced the initiation of the landmark BENEFIT HF trial following CMS approval of Category B IDE coverage last month. This prospective randomized controlled trial will evaluate impact on all-cause mortality and heart failure decompensation events in an expanded population with ejection fractions up to 50% and NT-proBNP levels up to 5,000. The trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients at approximately 100 centers in the United States and Germany. If successful, this trial would expand our prevalence-based addressable market from approximately 339,000 patients to over 980,000 patients, effectively tripling our market opportunity to approximately $30,000,000,000.

Importantly, patients with higher ejection fractions and NT-proBNP levels are already being seen by these same clinicians that we work with today, making this an easily accessible adjacent population. The CMS approval of Category B IDE coverage is critical, as it ensures Medicare coverage for patients enrolled in the trial, reimbursing hospitals at approximately $45,000 per procedure, consistent with current commercial reimbursement rates.

Operator: With CMS coverage secured,

Kevin Hykes: we expect to begin enrollment in 2026. The net cash impact from the trial is expected to be $20,000,000 to $30,000,000 spread over five to seven years, with the majority coming in the later years.

Operator: Beyond this randomized controlled trial,

Kevin Hykes: we continue to develop real-world evidence and to support investigator-initiated research demonstrating positive patient outcomes, including reductions in hospitalization, improved ejection fraction, and improvement in cardiac function. We also strengthened our balance sheet in early January through an amendment to our debt facility that extends the maturity date to 2031 and provides access to additional capital as we achieve certain milestones. In summary, 2025 was a year of building the right foundation for sustainable growth.

Operator: Transformed our sales organization with high quality talent,

Kevin Hykes: validated our program selling strategy with proof of

Operator: deeper adoption,

Kevin Hykes: and made significant progress in reducing the barriers to adoption, including significantly improving patient access to Barostim therapy. Importantly, we also secured approval and coverage for a landmark randomized controlled trial, which has now been initiated with first enrollments expected in 2026. While our growth rate reflected the natural ramp period for our newer sales reps, we made meaningful progress on the strategic elements necessary to drive improved performance. We believe these initiatives will support our accelerated growth and make Barostim therapy more accessible for heart failure patients in 2026 and beyond.

Operator: Before Jared discusses the financials,

Kevin Hykes: I am excited to announce that Greg Morrison was appointed as our new Chief Human Resources Officer and will be joining CVRx, Inc. in March. He will succeed our current CHRO, Tanya Austin, who is stepping back due to personal reasons. Greg brings over 30 years of leadership experience in medical devices, serving as the senior HR officer in seven different medical device companies. We are grateful to Tanya for her significant and impactful role in the

Jared Oasheim: transformation of our commercial team, and appreciate her continued support through the transition period. Now I will turn the call over to Jared for a detailed financial review.

Kevin Hykes: Thanks, Kevin. Unless otherwise stated, year-over-year comparisons are for the three months ended 12/31/2025 compared to the three months ended 12/31/2024. In the fourth quarter, total revenue generated was $16,000,000, an increase of $700,000, or 4%. Revenue generated in the U.S. was $14,900,000, an increase of $600,000, or 4%. Revenue units in the U.S. totaled 478 and 404 for the three months ended 12/31/2025 and 12/31/2024, respectively. The increase was primarily driven by continued growth because of the expansion into new sales territories and new accounts, as well as increased physician and patient awareness of Barostim.

We ended the year with a total of 252 active implanting centers as compared to 223 at the end of 2024, and 250 as of 09/30/2025. We had 53 sales territories in the U.S. at the end of the year compared to 48 at the end of 2024 and 50 on 09/30/2025. Revenue generated in Europe was $1,100,000, an increase of $100,000, or 10%. Total revenue units in Europe increased to 49 from 41 in the prior-year period. The number of sales territories in Europe remained consistent at five for the three months ended 12/31/2025. Gross profit was $13,800,000 for the three months ended 12/31/2025, an increase of $1,100,000, or 8%.

Gross margin increased to 86% compared to 83% a year ago. 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 $200,000, or 7%, to $3,000,000 compared to the prior-year period. This change was primarily driven by a $300,000 increase in compensation expenses, mainly as a result of increased headcount, partially offset by a $100,000 decrease in clinical study expenses. SG&A expenses increased $1,800,000, or 9%, to $22,000,000 compared to the prior-year period.

This change was driven by a $1,300,000 increase in compensation expenses, mainly as a result of increased headcount, a $500,000 increase in advertising expense, and a $300,000 increase in travel expense, partially offset by a $300,000 decrease in consulting expense. Interest expense decreased $100,000 to $1,400,000 from a year ago. This decrease was driven by the lower interest rate on the levels of borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net, was $700,000 compared to $1,100,000. This decrease was primarily driven by less interest income on our interest-bearing accounts. Net loss was $11,900,000, or $0.46 per share, for 2025 compared to a net loss of $10,700,000, or $0.43 per share, for 2024.

Net loss per share was based on 26,200,000 weighted-average shares outstanding for 2025 and 24,700,000 weighted-average shares outstanding for 2024. As of 12/31/2025, cash and cash equivalents were $75,700,000. Cash used in operating and investing activities was $40,800,000 for the year ended 12/31/2025, compared to $40,500,000 for the year ended 12/31/2024. Regarding our balance sheet, in January, we amended our term loan agreement with Innovatus Capital Partners to increase the existing facility by $50,000,000 to an aggregate principal amount of up to $100,000,000, subject to achieving certain milestones. At closing, we borrowed an additional $10,000,000, bringing our total outstanding principal to $60,000,000.

The interest-only period is extended four years from the closing date and is extendable to five years upon achieving certain revenue milestones.

Jared Oasheim: The term loans mature in May 2031. Now turning to guidance. For the full year of 2026, we expect total revenue between $63,000,000 and $67,000,000. We expect full year gross margin between 84% and 86%. We expect operating expenses to be between $103,000,000 and $107,000,000. For Q1 2026, we expect to report total revenue between $13,700,000 and $14,700,000. With that, I will now turn the call back over to Kevin for closing remarks.

Kevin Hykes: Thank you, Jared. As we look ahead, we have several catalysts in place that we believe will drive improved performance. The Category I CPT codes represent the culmination of years of work on the reimbursement front. We expect to see the benefits build throughout the year as prior authorization processes adapt to the new coding structure. Our sales organization is increasingly experienced and productive, with our transformation now largely behind us.

Operator: Finally,

Kevin Hykes: the initiation of the BENEFIT HF trial represents one of the most significant developments in our company's history. While this trial will not have material impact on our 2026 revenue results, it will create significant visibility, credibility, and goodwill in the heart failure community. On a long-term basis, if successful, BENEFIT HF positions us for meaningful long-term growth and will roughly triple our addressable market. We remain focused on our core mission, to positively impact the standard of care for heart failure and address a significant unmet need for hundreds of thousands of patients. We are confident in our ability to execute against that mission in the year ahead, and to reach significantly more patients in the years to come.

Now I would like to open the line for questions. Operator?

Operator: Thank you. Ladies and gentlemen, if you would like to ask a question, please press 1 on your telephone keypad. You may press 2 if you would like to remove your question from the queue. It may be necessary to pick up your handset before pressing the star keys. And the first question comes from the line of John Young with Canaccord Genuity. Please proceed.

Kevin Hykes: Hi, Kevin, Jared, congratulations on the strong end to the year. And thank you for taking the questions this evening. First, on BENEFIT HF.

John Young: On the strategy, can you talk about the initial sites? Will these be new or existing commercial sites? And what is the overlap in the current indication too? Will there be any revenue generation from the cases? Thank you.

Kevin Hykes: Sure. I will take that one, John. I appreciate the question. So there

Operator: we are early

Kevin Hykes: in the recruitment of centers. As we suggested, there will be about 150 centers in the U.S. with a handful in Germany. We are approaching these centers on the basis of their interest

John Young: in the therapy and their impact within the heart failure community. So there is a mix of centers that are already using Barostim in today's indicated population, and some that have not yet begun commercial implantation. And so I presume as we proceed through the site activation process, we will have a blend of centers even as we reach 150, but a significant number that have some experience already commercially with the therapy. Do you want to handle the revenue question, Jared? Sure.

Jared Oasheim: Hey, John. Yes. So right now, the trial design is set up where they are expecting 2,500 randomizations. It is set up where two-thirds of them will be randomized to the device arm and would require an implant. And each one of those units, we are expecting to be reimbursed by Medicare or Medicare Advantage plans for hospitals, so we would be selling those devices. So in total, we would be selling somewhere around 1,600 or 1,700 devices as a result of this trial.

John Young: Okay. That is helpful. Thank you. And then just the growth of active accounts in Q4, the sequential growth was a bit low. I am sure it is reflective of the sales strategy of going deep, but how should we expect that to trend through 2026? Again, thanks for taking our questions.

Jared Oasheim: Yes, great question. Yes. And we have always pointed this out, it is a net basis. Right? So we added more than the two, but we also sunset quite a few accounts here in the fourth. As we go into 2026, the guidance is still assuming that we are going to be adding around three territories on a quarterly basis. And as you know, John, our expectation is each one of those territories would be managing between three to five active implanting centers. So based on that growth alone, we are continuing to expect to be adding high single-digit account adds on a net basis each quarter in 2026.

John Young: Thanks so much.

Jared Oasheim: Thank you.

Operator: The next question comes from the line of Brandon Vazquez with William Blair. Please proceed.

Max Smock: Hey, Max on for Brandon. Thanks for taking the questions. Kevin, just on BENEFIT HF, just to double down on it. You know, you gave some good color in your prepared remarks, but I was just curious, do you guys see any scenario where, you know, some of the chatter around the trial can actually be a tailwind for the core business,

Operator: while the trial is going on.

Max Smock: Yes. Thanks, Max. I think that is a good question. The short answer is yes. While we do not

Kevin Hykes: expect significant revenue contribution from trial sites in this next year, there certainly will be a goodwill effect and a credibility effect

Operator: from the trial. This is, as we have said, the largest therapeutic device trial ever conducted in heart failure. We believe it is a landmark trial on that basis. It is a signal that we believe and have great confidence in this therapy.

Kevin Hykes: And I think we are starting to see some of that already. Positive feedback from the community. They are pleased at the scientific rigor and the scale of this trial, and they are excited to be part of it.

Operator: So the short answer is yes. From a goodwill standpoint, absolutely.

Kevin Hykes: That is helpful. And then, you know, I know we are only, call it, a month and a half into the year. But Category I code went into effect January 1. And I was just wondering if you guys could

Max Smock: share any, you know, anecdotal examples you have heard thus far on how that has helped lower barriers to treatment? I mean, maybe how you see that tailwind building throughout the year?

Operator: Thanks.

Max Smock: Sure. Thanks, Max. Yes, I would say we are still very much in transition mode.

Kevin Hykes: But it is progressing as we had expected. Right now, our focus is really on making sure that those codes are updated

Operator: with each of the payers,

Kevin Hykes: resubmitting prior auths that were in process in late 2025 that were sort of now caught

Operator: in the gap. So resubmitting them with the new codes and ensuring that all new submissions are using the new code. So it will take us

Kevin Hykes: some number of quarters likely to get through this transition, but we are in fact seeing payers who have historically rejected 100% of our prior auths now beginning to approve them.

Operator: We have also seen some of the Medicare Advantage payers approving at a higher rate and more quickly than they have historically. So early days, but certainly some positive signals. Great. Thanks for taking the questions. The next question comes from the line of Matthew O'Brien with Piper Sandler. Please proceed.

Anna: This is Anna on for Matt. Thanks for taking our questions. I guess I just wanted to ask on the guide at a high level. I know you have guided to 11% to 18% top-line growth. That is an acceleration from what we saw this year. So I was just wondering, you know, what gives you the confidence and what is contemplated in the low end and the high end of the guide.

Jared Oasheim: Yes, appreciate that question. So I think as we look back to 2025, we did go through a bit of a reset after the first quarter, understanding that we had cut a little bit deeper than initially anticipated within the sales organization. After that reset was done in 2025, we have seen pretty nice sequential growth from Q1 all the way through Q4 as we have continued to watch those new reps that we hired in 2024 and 2025 get further up the productivity curve. Now we do expect a bit of a seasonal dip from Q4 to Q1 as reflected in our guidance.

But after that seasonal dip going from Q4 to Q1, we do expect to see that return to sequential growth throughout the rest of the year. So it is what we are seeing within the sales reps and their productivity to date that is giving us the confidence to be able to see a reacceleration of growth in 2026.

Operator: Great. Thanks so much.

Jared Oasheim: Thank you.

Operator: The next question comes from the line of Robbie Marcus with JPMorgan. Please proceed.

Lily: Hi, this is Lily on for Robbie. Thanks for taking the question. There has been a lot of focus on building out and getting the salesforce to be more efficient. So can you talk a bit more about what you have been seeing lately in getting reps up the productivity curve and how we should be thinking about the pace of improvement over the course of 2026.

Jared Oasheim: Yes. Happy to dive in a little bit deeper on that one, Lily. So throughout 2025, we spent the first quarter making sure we had the right team members in place, maybe getting a few more of them hired in during the second and third quarter of the year. We have continued to see those reps go through the onboarding process, the training process, and more of them reaching the activation state, seeing that total number of active territories grow to 53 by the end of the year. We also saw the number of revenue units per territory continuing to increase as we went throughout 2025.

And, you know, I think we have mentioned, you know, some of the metrics at the account utilization level, but we are seeing more of our accounts achieving that point of one implant a month here in the fourth quarter. And so as we get more and more of those reps up that productivity curve, the expectation is they are going to be working on those workflows at those centers to build those flywheels to see more centers treating one a month. And so I think it is all of that positive momentum we saw throughout 2025 that gives us confidence to be able to continue to see growth in sales productivity as we go into '26.

Lily: Great. That is helpful. And then just as a follow-up, you have had a few nice quarters of gross margin in the 86% plus range. I see the guidance for 84% to 86% for 2026. Is there any reason this should go backwards? If you could highlight some of the key drivers we should be keeping in mind for gross margin this year, that would be helpful.

Jared Oasheim: Yes. I would say we were really happy with the results we saw in gross margin in 2025, both from the price standpoint and also the cost per unit standpoint. So in '25, we exceeded expectations on ASPs in the U.S., getting north of a $31,000 ASP. I think as we think about 2026, we do not want to get over our skis and start setting that as the expectation. So in our base case, in the guide, we are setting the expectation on the U.S. side of the business for ASPs of around $31,000. On the cost side, again, we continue to see manufacturing efficiencies throughout the year driving that cost per unit down.

We also understand that we have significant capacity at our manufacturing facility here in Minnesota to produce more and more units. So there is an opportunity to see that cost per unit come down further as we continue to produce more units. However, we are not baking that into the initial guide here for 2026.

Lily: Great. That is helpful. Thanks so much.

Operator: Thank you. The next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed.

Frank Takkinen: Great. Thanks for taking the questions.

Frank James Takkinen: I was going to start with one more on the BENEFIT trial. I am just curious on kind of how to think about how you expect this cohort of patients to react to the technology. And I think we have talked about this before and just making sure you get to patients prior to that disease state advancing to a more severe state. And if you are getting to them earlier, are you seeing a more durable response? Is that the expectation? Maybe it is less on absolute terms, but it is getting them closer to kind of pre-disease state. Just curious if you are treating some of these earlier-stage patients what your guys' expectation would look like. Sure.

Thanks, Frank. I will try to answer that.

Operator: You know, the

Frank James Takkinen: HFrEF population, those are patients between 35 and 50 ejection fraction, have not been widely studied historically. We have a decent sense of the event rates in that group,

Frank Takkinen: which you would expect to be a little bit lower than the event rates in the sicker

Frank James Takkinen: 35 below, the proper HFrEF population.

Kevin Hykes: But it is very much the same disease. Unlike HFpEF, which is a different disease, both HFmrEF and HFrEF are neurohormonal disorders. It is the same disease,

Frank James Takkinen: with differing degrees of severity. So we expect that they will respond to Barostim in a very similar fashion that the HFrEF patients do. Beyond that, obviously that is why we are running the trial,

Operator: it is a large trial because the event rates in that mrEF population are lower, so statistically, you need to study more patients to generate more events. But we would expect to see very similar responses from that population, whether it is on the primary endpoint of survival and of heart failure hospitalization or the secondary that relate to quality of life and other important clinical consideration.

Frank James Takkinen: So too early to tell, but we are confident that we have defined the trial in such a way and empowered it in such a way

Operator: that we can prove a difference in both of those populations.

Kevin Hykes: Whether we catch them earlier, slightly earlier in their disease,

Operator: or when they are properly below 35 as we do today. Hope that helps. Little complicated. Yes.

Frank James Takkinen: No. That is perfect. I appreciate it. And then just for my follow-up, going to ask maybe once more on kind of the center activation and strategy to go deeper. If you were to think about the guide, low end versus high end, what is more important? Is it the activation of the right centers, or is it more a same-store sales proposition?

Jared Oasheim: Yes. Appreciate that question, Frank. Yes. I mean, our goal here is to drive deeper adoption. And so that is priority number one for all of our sales reps, is make sure you have the right accounts activated first, but then second, to really start to build that network effect around those centers to make sure all the referral physicians and APPs know about this therapy and what types of patients it will help. And so it is all about driving deeper adoption and seeing that same-store sales number increase in 2026. In addition to that, we will be adding new territories, as I mentioned, so about three or so per quarter.

And each of those new territories are also going to be activating centers. So we will still see new center adds throughout 2026, but we believe the majority of the growth is going to come from deeper adoption at the existing centers.

Operator: Perfect.

Frank James Takkinen: Thanks for taking the questions.

Kevin Hykes: Yep.

Operator: And the final question will come from the line of Chase Knickerbocker with Craig-Hallum Capital Group. Please proceed.

Chase Knickerbocker: Good afternoon. Kevin, I just wanted to start on

Chase Richard Knickerbocker: some of those top accounts that you mentioned that exited the year at a pretty stark run rate from a device implant perspective. I mean, what do they have in common? I think particularly kind of around the stakeholders of those accounts, I would be interested to hear as far as kind of what resonated with them that made them, you know, such high-volume adopters fairly quickly. And then maybe kind of the characteristics and the approach of the salesperson as well. That would be helpful.

Max Smock: Sure. Thanks, Chase. I presume you are referring to the comment about the top 20% of our accounts are doing basically 19 units per year, about one and a half per month. Yes. So it is a great question, and it is

Frank James Takkinen: exactly what has—the insights from those accounts are what led us to refine and optimize our go-to-market strategy. And what we see in those accounts

Operator: are places where you have not just a single champion,

Frank James Takkinen: but in fact a supportive CEO or CFO that understands the profitability. You have multiple heart failure specialists that understand which patients can benefit.

Operator: You have a pool of cardiologists in the community who are screening patients and sending them in for evaluation. And you have redundancy at the surgeon level.

Frank James Takkinen: So that you can continue to consistently implant even when a surgeon goes on vacation or sabbatical or changes roles, etc. So it is sort of as simple as that. That is what we think good looks like.

Operator: And that is exactly how we are now incentivizing our sales team. We are paying them a premium for units that come from centers that have those very characteristics. Because we know when you have that sort of redundancy and you have that repeat utilization, that is sort of the flywheel that starts to turn, and that is what causes them to continue treating patients on their own.

Frank James Takkinen: Whether or not you remind them or not. So that is really the fundamental insights that drove our revised go-to-market strategy.

Chase Richard Knickerbocker: If you kind of take that cohort, Kevin, that 20%, what is the age of those accounts? Are there some that are, you know, fairly short? Maybe you kind of initiated them in '25 or early 2024. Or are those some of your accounts that have been implanting Barostim for the longest? It is probably across the board, but just some thoughts there as far as kind of

Max Smock: sure. How long it takes some of these accounts to get there.

Kevin Hykes: Yes. And what I can say definitively, it takes more than six months. Right? Because that

Operator: scenario that I described takes time to establish.

Frank James Takkinen: But I think beyond that—so there are none that are brand new, but there is a pretty wide spectrum, some of whom have been with us in developing that resilience and that flywheel for a number of years. There are some that are as new as nine months or even twelve months. So, again, some of that stems from us learning more

Operator: about the kinds of centers that can be successful and being more intentional

Frank James Takkinen: and disciplined about where we engage. Right? That network I described does you no good if the baseline

Operator: characteristics in the account are suboptimal. So you want to start with the right account, then you want to establish that network,

Frank James Takkinen: and then you want to get the flywheel turning. So it is a little bit of everything, thankfully.

Chase Richard Knickerbocker: Got it. Maybe just one on BENEFIT for me. What portion of the enrollment do you expect to be OUS? And, you know, we should not be thinking that there is, you know, revenue recognition there. I mean, that is something—it will just be expense. I mean, just kind of talk me through how much it will be OUS and then how you expect to treat it.

Kevin Hykes: That is a great question. It will be a very, very small number of centers.

Operator: For a number of the reasons you pointed out and some others.

Kevin Hykes: So this will very much be a U.S.-focused trial, a Medicare-focused trial, again with the benefit of the Category B

Frank James Takkinen: reimbursement sitting behind it.

Chase Richard Knickerbocker: So a very—a very small. And then just last, Jared, any thoughts on kind of path to profitability? You know, obviously, we have got some net expense from the trial. You know, just overall thoughts there. And if at some point, there is a decision to, you know, eventually kind of slow down the territory adds or just kind of help me think about how you expect to manage the business to profitability over the medium term?

Jared Oasheim: Yes. Appreciate the question. So right now, we had $75,000,000, $76,000,000 at the end of the year. We noted in our preannouncement in early January that we added $10,000,000 from the debt amendment, so up to $86,000,000 to start 2026. With the guide, you know, we are expecting to burn somewhere around $30,000,000 to $35,000,000 in 2026. But what we do know is we have at least two years of cash on the balance sheet today. We also have access to an additional $40,000,000 of nondilutive capital through the debt amendment, and those are triggered based on us hitting certain revenue milestones over the next couple of years. So we have access to plenty of capital today.

There is no need to go out and raise additional capital at this point in time. I also know there were some questions around the filing of the shelf and ATM in late 2025, early 2026. And that was purely good corporate housekeeping. Our old shelf had expired in 2025, so we needed to refresh the shelf and put a new one up this year. So with $86,000,000 in the bank, two-plus years of cash available to us, there is no need to go out and raise any additional capital at this point. As to the path to profitability, it is all about generating leverage. Right? We hired a whole bunch of really good reps.

It is now pushing them up that productivity curve to drive a faster growth rate on the top line than we are seeing on the SG&A line. And that is our plan—is that we are going to continue to drive them up that product curve and continue to add new heads to see that growth rate. We will in the coming years. But with $86,000,000 of cash, it is not a concern for us.

Operator: Understood. Thank you. Thank you. This concludes the question-and-answer session. I would like to turn the call back over to Kevin Hykes for closing remarks.

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: Thanks. This concludes today's conference. You may disconnect your lines at this time. Enjoy the rest of your day.

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