Q4 2025 CVRx Inc Earnings Call

February 12, 2026

Operator: Greetings, and welcome to the CVRx Q4 2025 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to introduce Mike Vallie of ICR. Please go ahead.

Speaker #3: If anyone requires operator assistance, please press *0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Mike Vallie of ICR.

Speaker #3: Please go ahead.

Speaker #2: Good afternoon. Thank you for joining us today for CVRx's fourth quarter and full year 2025 earnings conference call. Joining me on today's call are the company's President and Chief Executive Officer, Kevin Hykes, and Chief Financial Officer, Jared Oasheim.

Mike Vallie: Good afternoon. Thank you for joining us today for CVRx's Q4 and full year 2025 earnings conference call. Joining me on today's call are the company's President and Chief Executive Officer, Kevin Hykes, and Chief Financial Officer, Jared Oasheim. The remarks today will contain forward-looking statements, including statements about financial guidance. These statements are based on plans and expectations as of today, which may change over time. In addition, actual results could differ materially due to a number of risks and uncertainties, including those identified in the earnings release issued prior to this call and in the company's SEC filings. I would now like to turn the call over to CVRx's President and Chief Executive Officer, Kevin Hykes.

Speaker #2: During March today, we'll contain forward-looking statements, including statements about financial guidance. These statements are based on plans and good expectations as of today, which may change over time.

Speaker #2: 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.

Speaker #2: I would now like to turn the call over to CVRx's President and Chief Executive Officer, Kevin Hykes.

Speaker #3: 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 million, and full year revenue of $56.7 million, representing growth of 4% and 10% respectively.

Kevin Hykes: Thanks, Mike. Good afternoon, and thank you for joining us for our Q4 and full year 2025 earnings call. We delivered Q4 revenue of $16 million and full year revenue of $56.7 million, representing growth of 4% and 10%, respectively. 2025 was a year of important and necessary investment in our commercial foundation as 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's 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 by the heart failure community, suffer with significantly diminished quality of life, including limited mobility, chronic fatigue, and the inability to perform basic daily activities....

Speaker #3: 2025 was a year of important and necessary investment in our commercial foundation as we strengthened our sales organization, refined our go-to-market approach, and advanced critical initiatives that position us for growth ahead.

Speaker #3: As we reflect on the year, it's important to remember what drives our work. Heart failure affects 6.7 million symptomatic patients despite optimal medical therapy. These patients, often referred to as the "walking wounded" by the heart failure community, suffer with significantly diminished quality of life, including limited mobility, chronic fatigue, and the inability to perform basic daily activities.

Speaker #3: While guideline-directed medical therapy has demonstrated survival benefits when taken compliantly, it does very little to improve how patients actually feel on a day-to-day basis.

Kevin Hykes: While guideline-directed medical therapy has demonstrated survival benefits when taken compliantly, it does very little to improve how patients actually feel on a day-to-day basis. In fact, multiple studies in this population have consistently shown that these patients would trade longevity for better quality of life. They don't 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, Barostim 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's important to consider our indicated population, not just in terms of the annual incidence, but also the prevalence pool.

Speaker #3: In fact, multiple studies in this population would trade longevity for better quality of life. They don't want to simply live longer; they want to live better, to play with their grandchildren, to walk their dog, and to maintain their independence.

Speaker #3: Barostim addresses this critical unmet need. Unlike medications that primarily target survival, Barostim demonstrably improves exercise capacity and quality of life, giving patients back the ability to engage in the activities that matter most to them.

Speaker #3: When we talk about our market opportunity, it's important to consider our indicated population not just in terms of the annual incidence, but also the prevalence pool.

Speaker #3: While approximately 76,000 patients are newly diagnosed each year and enter our indication, heart failure is a chronic disease state. Patients are not only eligible for Barostim therapy in the year that they are diagnosed.

Kevin Hykes: While approximately 76,000 patients are newly diagnosed each year and enter our indication, heart failure is a chronic disease state. Patients are not only eligible for Barostim therapy in the year that they are diagnosed. They can live 4, 5, or 6 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 $10.5 billion market opportunity that remains well less than 1% penetrated. Our focus remains on making this therapy widely available to all patients who can benefit.

Speaker #3: 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 $10.5 billion market opportunity that remains well less than 1% penetrated.

Speaker #3: Our focus remains on making this therapy widely available to all patients who can benefit. In 2025, we built 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.

Kevin Hykes: In 2025, we built 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're pleased with the quality of talent that we've attracted and the progress that we're seeing in their development. By year-end, we'd 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.

Speaker #3: 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.

Speaker #3: We're pleased with the quality of talent that we've attracted and the progress that we're seeing in their development. By year-end, we'd expanded to 53 territories with 252 active implanting centers, up 10% and 13% respectfully.

Speaker #3: 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're increasingly confident in the team's ability to execute our program-focused selling approach as they gain experience.

Kevin Hykes: While integrating these many new representatives has created some near-term impact on growth, we're increasingly confident in the team's ability to execute our program-focused selling approach as they gain experience. We've also implemented several important changes to accelerate the productivity of our sales team. We've 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.

Speaker #3: We've also implemented several important changes to accelerate the productivity of our sales team. We've 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.

Speaker #3: 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.

Speaker #3: 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.

Kevin Hykes: 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're 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.

Speaker #3: The final necessary element is a defined Barosim 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.

Speaker #3: Barostim becomes part of how heart failure is episodic consideration. Importantly, in the accounts where this flywheel effect is beginning to take hold, we're seeing significant additional runway for much deeper penetration.

Speaker #3: 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.

Speaker #3: This demonstrates the substantial opportunity 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: patient access, therapy awareness, and clinical evidence.

Kevin Hykes: This demonstrates the substantial opportunity 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: patient access, therapy awareness, and clinical evidence. As it relates to patient access, the most significant and impactful development is our transition to Category I CPT codes, which took effect on January 1, 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.

Speaker #3: As it relates to patient access, the most significant and impactful development is our transition to Category I CPT codes, which took effect on January 1, 2026.

Speaker #3: This major milestone is an important validation of Barostim therapy from the perspective of physicians, hospitals, and payers. The Category 1 code will improve patient access by eliminating the automatic prior authorization denials associated with Category 3 codes.

Speaker #3: 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.

Speaker #3: We're 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.

Kevin Hykes: We're 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 Three code, and with the Category One code now in effect, we're 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.

Speaker #3: This represented remarkable progress for a therapy with a Category III code, and with the Category I code now in effect, we're optimistic that these approval rates will continue to improve.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Finally, regarding clinical evidence, we recently announced the initiation of the landmark BenefitHF trial following CMS approval of Category B IDE coverage last month. This prospective randomized controlled trial will evaluate Barosim's 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.

Kevin Hykes: 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 Barostim's 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 150 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 billion.

Speaker #3: 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 150 centers in the United States and Germany.

Speaker #3: 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 billion.

Speaker #3: Importantly, patients with higher ejection fractions and NT-proBNP levels are already being seen by these same clinicians that we work with today, making 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.

Kevin Hykes: 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. With CMS coverage secured, we expect to begin enrollment in Q2 2026. The net cash impact from the trial is expected to be $20 million to $30 million, spread over 5 to 7 years, with the majority coming in the later years. Beyond this randomized controlled trial, 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.

Speaker #3: With CMS coverage secured, we expect to begin enrollment in the second quarter of 2026. The net cash impact from the trial is expected to be $20 million to $30 million, spread over five to seven years, with the majority coming in the later years.

Speaker #3: Beyond this randomized controlled trial, 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.

Speaker #3: 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.

Kevin Hykes: 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. We transformed our sales organization with high-quality talent, validated our program selling strategy with proof of deeper adoption, 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 Q2 of 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.

Speaker #3: In summary, 2025 was a year of building the right foundation for sustainable growth. We transformed our sales organization with high-quality talent, validated our program selling strategy with proof of deeper adoption, and made significant progress in reducing the barriers to adoption, including significantly improving patient access to Barostim therapy.

Speaker #3: Importantly, we also secured approval and coverage for a landmark randomized controlled trial, which has now been initiated with first enrollments expected in the second quarter of 2026.

Speaker #3: 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.

Speaker #3: We believe these initiatives will support our accelerated growth and make Barosim therapy more accessible for heart failure patients in 2026 and beyond. Before Jared discusses the financials, I'm excited to announce that Greg Morrison was appointed as our new Chief Human Resources Officer and will be joining CVRx in March.

Kevin Hykes: We believe these initiatives will support our accelerated growth and make Barostim therapy more accessible for heart failure patients in 2026 and beyond. Before Jared discusses the financials, I'm excited to announce that Greg Morrison was appointed as our new chief human resources officer and will be joining CVRx 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 7 different medical device companies. We are grateful to Tanya for her significant and impactful role in the transformation of our commercial team, and appreciate her continued support through the transition period. Now I'll turn the call over to Jared for a detailed financial review.

Speaker #3: 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.

Speaker #3: We are grateful to Tanya for her significant and impactful role in the transformation of our commercial team, and appreciate her continued support through the transition period.

Speaker #3: Now, I'll turn the call over to Jared for a detailed financial review.

Speaker #2: Thanks, Kevin. Unless otherwise stated, year-over-year comparisons are for the three months ended December 31, 2025, compared to the three months ended December 31, 2024.

Jared Oasheim: Thanks, Kevin. Unless otherwise stated, year-over-year comparisons are for the three months ended December 31, 2025, compared to the three months ended December 31, 2024. In Q4, total revenue generated was $16 million, an increase of $0.7 million or 4%. Revenue generated in the US was $14.9 million, an increase of $0.6 million or 4%. Revenue units in the US totaled 478 and 460 for the three months ended December 31, 2025 and 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.

Speaker #2: In the fourth quarter, total revenue generated was $16 million, an increase of $0.7 million or 4%. Revenue generated in the U.S. was $14.9 million, an increase of $0.6 million or 4%.

Speaker #2: Revenue units in the U.S. totaled 478 and 460 for the three months ended December 31, 2025 and 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.

Speaker #2: 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 September 30, 2025.

Jared Oasheim: 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 30 September 2025. We had 53 sales territories in the US at the end of the year, compared to 48 at the end of 2024 and 50 on 30 September 2025. Revenue generated in Europe was $1.1 million, an increase of $0.1 million 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 5 for the three months ended 31 December 2025.

Speaker #2: We had $53 sales territories in the US at the end of the year, compared to $48 at the end of 2024 and $50 on September 30, 2025.

Speaker #2: Revenue generated in Europe was $1.1 million, an increase of $0.1 million or 10%. Total revenue units in Europe increased to 49 from 41 in the prior-year period.

Speaker #2: The number of sales territories in Europe remained consistent at five for the three months ended December 31, 2025. Gross profit was $13.8 million for the three months ended December 31, 2025, an increase of $1.1 million, or 8%.

Jared Oasheim: Gross profit was $13.8 million for the three months ended December 31, 2025, an increase of $1.1 million 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 $0.2 million or 7% to $3 million, compared to the prior year period. This change was primarily driven by a $0.3 million increase in compensation expenses, mainly as a result of increased headcount, partially offset by a $0.1 million decrease in clinical study expenses. SG&A expenses increased $1.8 million or 9% to $22 million, compared to the prior year period.

Speaker #2: 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.

Speaker #2: R&D expenses increased $0.2 million, or 7%, to $3.0 million compared to the prior year period. This change was primarily driven by a $0.3 million increase in compensation expenses, mainly as a result of increased headcount, partially offset by a $0.1 million decrease in clinical study expenses.

Speaker #2: SG&A expenses increased 1.8 million or 9% to $22 million, compared to the prior year period. This change was driven by a 1.3 million increase in compensation expenses mainly as a result of increased increase in advertising expense, and a 0.3 million increase in travel expense, partially offset by a 0.3 million decrease in consulting expense.

Jared Oasheim: This change was driven by a $1.3 million increase in compensation expenses, mainly as a result of increased headcount, a $0.5 million increase in advertising expense, and a $0.3 million increase in travel expense, partially offset by a $0.3 million decrease in consulting expense. Interest expense decreased $0.1 million to $1.4 million compared to 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 $0.7 million, compared to $1.1 million. This decrease was primarily driven by less interest income on our interest-bearing accounts.

Speaker #2: Interest expense decreased 0.1 million to 1.4 million, compared to 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.

Speaker #2: Other income net was 0.7 million compared to $1.1 million, this decrease was primarily driven by less interest income on our interest-bearing accounts. Net loss was $11.9 million, or 46 cents per share for the fourth quarter of 2025, compared to a net loss of $10.7 million or 43 cents per share for the fourth quarter of 2024.

Jared Oasheim: Net loss was $11.9 million, or $0.46 per share for Q4 2025, compared to a net loss of $10.7 million, or $0.43 per share for Q4 2024. Net loss per share was based on 26.2 million weighted average shares outstanding for Q4 2025, and 24.7 million weighted average shares outstanding for Q4 2024. As of December 31, 2025, cash and cash equivalents were $75.7 million. Cash used in operating and investing activities was $40.8 million for the year ended December 31, 2025, compared to $40.5 million for the year ended December 31, 2024.

Speaker #2: Net loss per share was based on 26.2 million weighted average shares outstanding for the fourth quarter of 2025 and 24.7 million weighted average shares outstanding for the fourth quarter of 2024.

Speaker #2: As of December 31, 2025, cash and cash equivalents were $75.7 million. Cash used in operating and investing activities was $40.8 million, for the year ended December 31, 2025, compared to $40.5 million for the year ended December 31, 2024.

Speaker #2: Regarding our balance sheet in January, we amended our term loan agreement with Innovatus Capital Partners to increase the existing facility by $50 million to an aggregate principal amount of up to $100 million.

Jared Oasheim: Regarding our balance sheet, in January, we amended our term loan agreement with Innovatus Capital Partners to increase the existing facility by $50 million to an aggregate principal amount of up to $100 million, subject to achieving certain milestones. At closing, we borrowed an additional $10 million, bringing our total outstanding principal to $60 million. The interest-only period is extended 4 years from the closing date and is extendable to 5 years upon achieving certain revenue milestones. The term loans mature in May 2031. Now turning to guidance. For the full year of 2026, we expect total revenue between $63 and 67 million. We expect full-year gross margin between 84% and 86%. We expect operating expenses to be between 103 and 107 million dollars.

Speaker #2: Subject to achieving certain milestones. At closing, we borrowed an additional $10 million bringing our total outstanding principal to $60 million. The interest-only period is extended four years from the closing date, and is extendable to five years upon achieving certain revenue milestones.

Speaker #2: The term loans mature in May 2031. Now turning to guidance. For the full year of 2026, we expect total revenue between $63 million and $67 million.

Speaker #2: We expect full-year gross margin between 84% and 86%. We expect operating expenses to be between $103 and $107 million. For the first quarter of 2026, we expect to report total revenue between $13.7 million and $14.7 million.

Jared Oasheim: For Q1 2026, we expect to report total revenue between $13.7 million and 14.7 million. With that, I'll now turn the call back over to Kevin for closing remarks.

Speaker #2: With that, I'll now turn the call back over to Kevin for closing remarks.

Speaker #1: 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, and we expect to see the benefits build throughout the year as prior authorization processes adapt to the new coding structure.

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, and 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. Finally, the initiation of the BENEFIT-HF trial represents one of the most significant developments in our company's history. While this trial won't 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.

Speaker #1: Our sales organization is increasingly experienced and productive, with our transformation now largely behind us. Finally, the initiation of the Benefit HF trial represents one of the most significant developments in our company's history.

Speaker #1: While this trial won't have a material impact on our 2026 revenue results, it will create significant visibility, credibility, and goodwill in the heart failure community.

Speaker #1: 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.

Kevin Hykes: 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're 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'd like to open the line for questions. Operator?

Speaker #1: We're confident in our ability to execute against that mission in the year ahead, and to reach significantly more patients in the years to come.

Speaker #1: Now, I'd like to open the line for questions. Operator?

Speaker #3: Thank you. Ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad. And a confirmation tone will indicate that your line is in the question queue.

Operator: Thank you. Ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad, and a confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. The first question comes from the line of John Young with Canaccord Genuity. Please proceed.

Speaker #3: 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.

Speaker #3: One moment, please, while we pull for questions. And the first question comes from the line of John Young with Canticore Genuity. Please proceed.

Speaker #4: Hi, Kevin, Jared. Congratulations on the strong end of the year, and thank you for taking the questions this evening. First, on benefit HF, on the strategy, can you talk about the initial sites?

John Young: Hi, Kevin, Jared. Congratulations on the strong end to the year, and thank you for taking the questions this evening. First, on BENEFIT-HF, on the strategy, can you talk about the initial sites? Will these be new or existing commercial sites? And, what's the overlap in the current indication too? Will there be any revenue generation from the cases? Thank you.

Speaker #4: Will these be new or existing commercial sites? And what's the overlap in the current indication to will there be any revenue generation from the cases?

Speaker #4: Thank you.

Speaker #3: Sure. I'll take that one, John. I appreciate the question. So, they're early in the recruitment of centers. As we suggested, there'll be about 150 centers in the U.S., with a handful in Germany.

Kevin Hykes: Sure. I'll take that one, John. I appreciate the question. So there are... We're early in the recruitment of centers. As we suggested, there'll be about 150 centers in the US, with a handful in Germany. We're approaching these centers on the basis of their interest 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?

Speaker #3: We're approaching these centers on the basis of their interest 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.

Speaker #3: 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.

Speaker #3: Do you want to handle the revenue question, Jared?

Speaker #4: Sure. Hey, John. Yeah. So right now, the trial design is set up where we're expecting 2,500 randomizations. It's set up where two-thirds of them will be randomized to the device arm, and would require an implant.

Jared Oasheim: Sure. Hey, John. Yeah, so right now, the trial design is set up where we're expecting 2,500 randomizations. It's 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.

Speaker #4: 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.

Speaker #4: So, in total, we would be selling somewhere around 1,600 or 1,700 devices as a result of this trial.

Speaker #1: Okay. That's helpful. Thank you. And then just the growth of active accounts in Q4, the sequential growth was a bit low. I'm sure it's reflective of the sales strategy of going deep, though.

John Young: Okay, that's helpful. Thank you. And then just the growth of active accounts in Q4, the sequential growth was a bit low. I'm sure it's reflective of the, the sales strategy of going deep, though, but, you know, how should we expect that to trend through 2026? Thanks again for taking our questions.

Speaker #1: But how should we expect that to trend through 2026? Thanks again for taking our questions.

Speaker #3: Yeah, great question. Yeah. And we've 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 quarter.

Jared Oasheim: Yeah, great question. Yeah, and we've always pointed this out; it is a net basis, right? So we added more than the 2, but we also sunset quite a few accounts here in Q4. As we go into 2026, the guidance is still assuming that we're gonna be adding around 3 active territories on a quarterly basis. And as you know, John, our expectation is each one of those territories would be managing between 3 to 5 active implanting centers. So based on that growth alone, we're continuing to expect to be adding high single-digit account adds on a net basis each quarter in 2026.

Speaker #3: As we go into 2026, the guidance is still assuming that we're going to be adding around three active territories on a quarterly basis. And as you know, John, our expectation is each one of those territories would be managing between 3 to 5 active implanting centers.

Speaker #3: So based on that growth alone, we're continuing to expect to be adding high single-digit account ads on a net basis each quarter in 2026.

Speaker #1: Thanks so much.

John Young: Thank you so much.

Speaker #3: Thank you. The next question comes from the line of Brendan Vasquez with William Blair. Please proceed.

Jared Oasheim: Thank you.

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

Speaker #5: Hi, guys. It's Maxon from Brandon. Thanks for taking the questions. Kevin, just on benefit HF, just to double down on it—you gave some good color in your prepared remarks, but I was just curious, do you guys see any scenario where some of the chatter around the trial can actually be a tailwind for the core business while the trial is going on?

Max Smock: Hey, guys. 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 while the trial is going on?

Speaker #3: Yeah, thanks, Max. I think that's a good question. The short answer is yes. While we don't expect significant revenue contribution from trial sites in this next year, there certainly will be a goodwill effect and a credibility effect from the trial.

Kevin Hykes: Yeah. Thanks, Max. I think that's a good question. The short answer is yes. You know, while we don't expect significant revenue contribution from trial sites in this next year, there certainly will be a goodwill effect and a credibility effect from the trial. This is, as we've said, the largest therapeutic device trial ever conducted in heart failure. We believe it's a landmark trial on that basis. It's a signal that we believe and have great confidence in this therapy, and I think we're starting to see some of that already. Positive feedback from the community. They're pleased at the scientific rigor and the scale of this trial, and they're excited to be part of it. So the short answer is yes, from a goodwill standpoint, absolutely.

Speaker #3: This is, as we've said, the largest therapeutic device trial ever conducted in heart failure. We believe it's a landmark trial on that basis. It's a signal that we believe and have great confidence in this therapy.

Speaker #3: And I think we're starting to see some of that already—positive feedback from the community. They're pleased with the scientific rigor and the scale of this trial.

Speaker #3: And they're excited to be part of it. So the short answer is yes, from a goodwill standpoint, absolutely.

Speaker #5: That's helpful. And then I know we're only call it a month and a half into the year, but category one code went into effect January 1st.

Max Smock: That's helpful. And then, you know, I know we're only, call it a month and a half into the year, but Category I code went into effect 1 January. And I was just wondering if you guys could share any, you know, anecdotal examples you've heard thus far on how that's helped, you know, lower barriers to treatment, and maybe how you see that tailwind building throughout the year. Thanks.

Speaker #5: And I was just wondering if you guys could share any anecdotal examples you've heard thus far on how that's helped lower barriers to treatment, and maybe how you see that tailwind building throughout the year.

Speaker #5: Thanks.

Kevin Hykes: Sure. Thanks, Max. Yeah, I would say we are still very much in transition mode, but it is progressing as we had expected. You know, right now our focus is really on making sure that those codes are updated with each of the payers, resubmitting prior auths that were in process in late 2025 that were sort of now caught in the gap, so resubmitting them with the new codes and ensuring that all new submissions are using the new codes. So it will take us 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. We've also seen some of the Medicare Advantage payers approving at a higher rate and more quickly than they have historically.

Speaker #3: Sure. Thanks, Max. Yeah. And I would say we are still very much in transition mode. But it is progressing as we had expected. Right now, our focus is really on making sure that those codes are updated with each of the payers.

Speaker #3: Resubmitting prior auths that were in process in late ’25 that were sort of now caught in the gap. So, resubmitting them with the new codes.

Speaker #3: And ensuring that all new submissions are using the new code. So it will take us 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.

Speaker #3: We've also seen some of the Medicare Advantage payers approving at a more at a higher rate and more quickly than they have historically. So early days, but certainly some positive signals.

Kevin Hykes: Early days, but certainly some positive signals.

Speaker #5: Great. Thanks for taking the questions.

Max Smock: Great. Thanks for taking the questions.

Speaker #3: The next question comes from the line of Matthew O'Brien with Piper Sandler. Please proceed.

Operator: The next question comes from the line of Matthew O'Brien with Piper Sandler. Please proceed.

Speaker #6: Hi there, this is Ana on from Matt. Thanks for taking your questions. I guess I just wanted to ask on the guide, sort of high level—I know you've guided to 11 to 18 percent top-line growth.

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

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

Speaker #6: That's an acceleration from what we saw this year. So I was just wondering, what could drive the confidence, and what's contemplated in the low end and the high end of the guide?

Speaker #5: Yeah. I 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.

Jared Oasheim: Yeah, 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 to cut a little bit deeper than it initially anticipated within the sales organization. After that reset was done in the first quarter of 2025, we've seen pretty nice sequential growth from Q1 all the way through Q4, as we've 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.

Speaker #5: After that reset was done in the first quarter of 2025, we've seen pretty nice sequential growth from Q1 all the way through Q4 as we've continued to watch those new reps that we hired in 2024 and 2025 get further up the productivity curve.

Speaker #5: 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.

Speaker #5: So, it's what we're seeing within the sales reps and their productivity to date that is giving us the confidence to be able to see a re-acceleration of growth in 2026.

Jared Oasheim: So it's what we're seeing within the sales reps and their productivity to date that is giving us the confidence to be able to see a re-acceleration of growth in 2026.

Speaker #6: Great. Thanks so much.

Anna: Great. Thanks so much.

Anna Andreeva: Great. Thanks so much.

Speaker #3: Thank you. The next question comes from the line of Robbie Marcus with J.P. Morgan. Please proceed.

Jared Oasheim: Thank you.

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

Speaker #7: Hi. This is Lily on for Robbie. Thanks for taking the question. There's been a lot of focus on building out and getting the Salesforce to be more efficient.

Lily Lozada: Hi, this is Lily on for Robbie. Thanks for taking the question. There's been a lot of focus on building out and getting the sales force to be more efficient. So can you talk a bit more about what you've 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?

Speaker #7: So, can you talk a bit more about what you've 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?

Speaker #3: Yeah. 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.

Jared Oasheim: ... Yeah, happy to dive in a little bit deeper on that one, Lily. So, you know, 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've 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.

Speaker #3: We've 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.

Speaker #3: We also saw the number of revenue units per territory continuing to increase as we went throughout 2025. And I think we've mentioned 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.

Jared Oasheim: You know, I think we've 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 Q4. So as we get more and more of those reps up that productivity curve, the expectation is they're gonna be working on those workflows at those centers to build those flywheels, to see more centers treating one a month. So I think it's, it's 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 2026.

Speaker #3: And so as we get more and more of those reps up that productivity curve, the expectation is they're going to be working on those workflows at those centers to build those flywheels to see more centers treating one a month.

Speaker #3: And so I think it's 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.

Speaker #6: Great, that's helpful. And then, just as a follow-up, you've had a few nice quarters of gross margin in the 86% plus range. I see the guidance for 84% to 86% for 2026.

Lily Lozada: Great, that's helpful. Then just as a follow-up, you've had a few nice quarters of gross margin in the 86%+ 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.

Speaker #6: 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.

Speaker #3: Yeah, 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.

Jared Oasheim: Yeah, 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 2025, we exceeded expectations on ASPs in the US, getting north of a $31,000 ASP. I think as we think about 2026, we don't wanna get over our skis and start setting that as the expectation. So in our base case, in the guide, we're setting the expectation on the US 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.

Speaker #3: So in '25, we exceeded expectations on ASPs in the US getting north of a $31,000 ASP. I think as we think about 2026, we don't want to get over our skis and start setting that as the expectation.

Speaker #3: So in our base case, in the guide, we're setting the expectation on the US 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.

Speaker #3: We've also understood 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.

Jared Oasheim: So there is an opportunity to see that cost per unit come down further as we continue to produce more units. However, we're not baking that into the initial guide here for 2026.

Speaker #3: However, we're not baking that into the initial guide here for 2026.

Speaker #6: Great. That's helpful. Thanks so much.

Lily Lozada: Great. That's helpful. Thanks so much.

Speaker #3: Thank you. The next question comes from the line of Frank Takinen with Wick Street Capital Markets. Please proceed.

Jared Oasheim: Thank you.

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

Speaker #5: Great. Thanks for taking the questions. I was going to start with one more on the benefit trial. I'm just curious and kind of how to think about how you expect this cohort of patients to react to the technology.

Frank Takkinen: Great, thanks for taking the questions. I was gonna start with one more on the BENEFIT trial. I'm just curious on kinda how to think about how you expect this cohort of patients to react to the technology. And I think we've 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're getting to them earlier, are you seeing a more durable response? Is that the expectation? Maybe it's less on absolute terms, but it's getting them closer to kind of pre-disease state. Just curious if you're treating some of these earlier stage patients, what your guys' expectation would look like.

Speaker #5: And I think we've talked about this before and just making sure you get to patients prior to that disease state advancing to a more severe state.

Speaker #5: And if you're getting to them earlier, are you seeing a more durable response? Is that the expectation? Maybe it's less on absolute terms, but it's getting them closer to kind of pre-disease state.

Speaker #5: Just curious if you're treating some of these earlier-stage patients, what your guys' expectation would look like.

Speaker #3: Sure. Thanks, Frank. I'll try to answer that. The HEF/MREF 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, which you'd expect to be a little bit lower than the event rates in the sicker 35 below that the proper HEF/REF population.

Kevin Hykes: Sure. Thanks, Frank. I'll try to answer that. You know, the HFpEF/MREF 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, which you'd expect to be a little bit lower than the event rates in the sicker 35 below that, the proper HFpEF population, but it is very much the same disease. Unlike HFpEF, which is a different disease, both HFpEF/MREF and HFrEF are neurohormonal disorders. It's the same disease 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's why we're running the trial.

Speaker #3: But it is very much the same disease. Unlike HEF/PEF, which is a different disease, both HEF/MREF and HEF/REF are neurohormonal disorders. It's the same disease, with differing degrees of severity.

Speaker #3: So we expect that they will respond to Barostim in a very similar fashion that the HEF/REF patients do. Beyond that, obviously, that's why we're running the trial.

Speaker #3: It's 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.

Kevin Hykes: It's 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's on the primary endpoint of survival and heart failure hospitalization, or the secondary endpoints that relate to quality of life and other kind of important clinical consideration. 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, that we can prove a difference in both of those populations, whether we catch them earlier, slightly earlier in their disease, or when they're properly below 35, as we do today. Hope that helped. A little complicated.

Speaker #3: But we would expect to see very similar responses from that population, whether it's on the primary endpoint of survival and of heart failure hospitalization, or the secondary endpoints that relate to quality of life and other kind of important clinical considerations.

Speaker #3: 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 that we can prove a difference in both of those populations—whether we catch them slightly earlier in their disease, or when they're properly below 35, as we do today.

Speaker #3: Hope that helped. A little complicated.

Speaker #5: Yeah, no, that's perfect. I appreciate it. And then just for my follow-up, I was going to ask maybe once more on kind of the center activation and strategy to go deeper.

Frank Takkinen: Yeah. No, that's perfect. I appreciate it. And then, just for my follow-up, I was gonna 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's more important? Is it the activation of the right centers, or is it more a same-store sales proposition?

Speaker #5: If you were to think about the guide, low-end versus high-end, what's more important? Is it the activation of the right centers, or is it more a same-store sales proposition?

Speaker #3: Yeah. Appreciate that question, Frank. Yeah. I mean, our goal here is to drive deeper adoption. And so that is priority number one for all of our sales reps is to make sure you got 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.

Jared Oasheim: Yeah, appreciate that question, Frank. Yeah, I mean, our goal here is to drive deeper adoption, and so that is priority number 1 for all of our sales reps, is to make sure you got 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's 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 3 or so per quarter, and each of those new territories are also gonna be activating centers. So we will still see new center adds throughout 2026....

Speaker #3: And so, it's 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.

Speaker #3: 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 ads throughout 2026, but we believe the majority of the growth is going to come from deeper adoption at the existing centers.

Jared Oasheim: But we believe the majority of the growth is gonna come from deeper adoption at the existing centers.

Speaker #5: Perfect. Thanks for taking the questions.

Max Smock: Perfect. Thanks for taking the questions.

Frank Takkinen: Perfect. Thanks for taking the questions.

Speaker #3: Yep.

Jared Oasheim: Yep.

Speaker #1: And the final question will come from the line of Chase Knickerbocker with Craig Howland Capital Group. Please proceed.

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

Speaker #5: Good afternoon. Kevin, I just wanted to start on 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?

Chase Knickerbocker: Good afternoon. Kevin, I just wanted to start on some of those top accounts that you mentioned that, you know, exited the year at a pretty, you know, stark run rate, from a device implant perspective. I mean, what do they have in common? I think particularly kind of around the stakeholders at those accounts, I'd 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'd be helpful.

Speaker #5: I think particularly kind of around the stakeholders that those accounts I'd be interested to hear as far as kind of what resonated with them that made them such high-volume adopters fairly quickly.

Speaker #5: And then maybe kind of the characteristics and the approach of the salesperson as well. That'd be helpful.

Speaker #3: Sure. Thanks, Chase. I presume you're referring to the comment about the 20%, our top 20% of accounts are doing basically 19 units per year or about one and a half per month.

Kevin Hykes: Sure. Thanks, Chase. I presume you're referring to the comment about the 20%, our top 20% of accounts are doing basically 19 units per year, or about 1.5 per month?

Speaker #3: So it's a great question. And it's exactly what has the insights from those accounts are what led us to refine and optimize our go-to-market strategy.

Chase Knickerbocker: Yes.

Kevin Hykes: So it's a great question, and it's exactly what 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 are places where you have not just a single champion, but in fact, a supportive CEO or CFO that understands the profitability. You have multiple heart failure specialists that understand which patients can benefit. You've got a pool of cardiologists in the community who are screening patients and sending them in for evaluation. And you've got redundancy at the surgeon level, so that you can continue to consistently implant, even when a surgeon goes on vacation or sabbatical or changes roles, et cetera. So it's sort of as simple as that. That's what we think good looks like, and that's exactly how we're now incentivizing our sales team.

Speaker #3: And what we see in those accounts are places where you have not just a single champion, but in fact, a supportive CEO or CFO that understands the profitability.

Speaker #3: You have multiple heart failure specialists that understand which patients can benefit. You've got a pool of cardiologists in the community who are screening patients and sending them in for evaluation.

Speaker #3: And you've got redundancy at the surgeon level so that you can continue to consistently implant even when a surgeon goes on vacation or sabbatical or changes roles, etc.

Speaker #3: So it's sort of as simple as that. That's what we think good looks like. And that's exactly how we're now incentivizing our sales team.

Speaker #3: We're 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's sort of the flywheel that starts to turn.

Kevin Hykes: We're paying them a premium for units that come from centers that have those very characteristics, 'cause we know when you have that sort of redundancy and you have that, that repeat utilization, that's sort of the flywheel that starts to turn, and that's what causes them to continue treating patients on their own, whether or not you remind them, or not. So that's really the fundamental insights that drove our revised go-to-market strategy.

Speaker #3: And that's what causes them to continue treating patients on their own, whether or not you remind them or not. So that's really the fundamental insights that drove our revised go-to-market strategy.

Speaker #5: If you kind of take that cohort, Kevin, that 20%, what's kind of the age of those accounts? Are there some that are fairly short?

Chase Knickerbocker: If you kinda take that cohort, Kevin, that 20%, what's kind of the age of those accounts? Are there some that are, you know, fairly short, maybe you kind of initiated them in 2025 or early 2024, or are those some of your accounts that have been implanting Barostim for the longest? It's probably across the board, but just some thoughts there as far as kind of-

Speaker #5: Maybe you kind of initiated them in '25 or late '24. Or are those some of your accounts that have been implanting Barostim for the longest?

Speaker #5: It's probably across the board, but just some thoughts there as far as kind of how long it takes some of these accounts to get there.

Kevin Hykes: Sure

Chase Knickerbocker: ... how long it takes some of these accounts to get there.

Speaker #3: Yeah. And what I can say definitively—it takes more than six months, right? Because that sort of scenario that I described takes time to establish.

Kevin Hykes: Yeah. And what I can say definitively, it takes more than six months, right? Because that sort of scenario that I described takes time to establish. But I think beyond that, so there are none that are brand new, but there are a pretty wide spectrum, some of whom have been with us in developing those, 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, that's some of that stems from us learning more about the kinds of centers that can be successful in being more intentional and disciplined about where we engage, right? That network I described does you no good if the baseline characteristics in the account are suboptimal.

Speaker #3: But I think beyond that, so there are none that are brand new, but there are pretty wide spectrum, some of whom have been with us in developing those that resilience and that flywheel for a number of years.

Speaker #3: There's some that are as new as nine months or even 12 months. So again, that's some of that stems from us learning more about the kinds of centers that can be successful in being more intentional and disciplined about where we engage, right?

Speaker #3: That network I described does you no good if the baseline characteristic in the account are suboptimal. So you want to start with the right account.

Kevin Hykes: So you want to start with the right account, then you want to establish that network, and then you want to get the flywheel turning. So it's a little bit of everything, thankfully.

Speaker #3: Then you want to establish that network, and then you want to get the flywheel turning. So it's a little bit of everything, thankfully.

Speaker #5: Got it. Maybe just one on benefit for me. What portion of the enrollment do you expect to be OUS? And we shouldn't be thinking that there's revenue recognition there.

Chase 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 shouldn't be thinking that there's, you know, revenue recognition there. I mean, that's something where it'll, it'll just be expense. I mean, just kind of talk me through how much-

Speaker #5: I mean, that's something where it'll just be expense. I mean, just kind of talk me through how much enrollment do you expect OUS, and then how you expect to treat it.

Kevin Hykes: Yeah, it'll be a-

Chase Knickerbocker: enrollment you expect OUS, and then how you expect to treat it?

Speaker #3: That's a great question. It'll be a very, very small number of centers. For a number of the reasons you pointed out and some others.

Kevin Hykes: That's a great question. It'll be a very, very small number of centers for a number of the reasons you pointed out and some others. So this will very much be a US-focused trial, a Medicare-focused trial, again, with the benefit of the Category B reimbursement, sitting behind it.

Speaker #3: So this will very much be a US-focused trial, a Medicare-focused trial. Again, with the benefit of the category B reimbursement sitting behind it.

Chase Knickerbocker: So a very, a very small number. And then just last, Jared, any thoughts on kind of path to profitability? You know, obviously, we've 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.

Speaker #5: a very small number. And then just last, Jared, any thoughts on kind of path to profitability? Obviously, we've got some net expense from the trial.

Speaker #5: Just overall thoughts there and if at some point there is a decision to eventually kind of slow down the territory ads or just kind of help me think about how you expect to manage the business to profitability over the medium term.

Speaker #3: Yeah. Appreciate the question. So right now, we had 75 million, 76 million at the end of the year. We noted in our pre-announcement in early January that we added an additional 10 million dollars from the debt amendment.

Jared Oasheim: Yeah, appreciate the question. So right now, we had $75 million, $76 million at the end of the year. We noted in our pre-announcement in early January that we added an additional $10 million from the debt amendment, so up to $86 million to start 2026. With the guide, you know, we're expecting to burn somewhere around $30 to 35 million 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 million of non-dilutive 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.

Speaker #3: So up to 86 million dollars to start 2026. With the guide, we're expecting to burn somewhere around 30 to 35 million dollars in 2026.

Speaker #3: 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 million dollars of non-dilutive capital through the debt amendment.

Speaker #3: 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.

Speaker #3: There is no need to go out and raise additional capital at this point in time. And I also know there were some questions around the filing of the shelf and the ATM in late '25, early '26.

Jared Oasheim: 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 the fall of 2025, so we needed to refresh the shelf and put a new one up this year. With $86 million in the bank, 2+ years of cash available to us, there's no need to go out and raise any additional capital at this point. As to the path to profitability, it's all about generating leverage, right? We hired a whole bunch of really good reps.

Speaker #3: And that was purely good corporate housekeeping. Our old shelf had expired in the fall of '25. So we needed to refresh the shelf and put a new one up this year.

Speaker #3: So with 86 million dollars in the bank, two plus years of cash available to us, there's no need to go out and raise any additional capital at this point.

Speaker #3: As to the path to profitability, it's all about generating leverage, right? We hired a whole bunch of really good reps. It's now pushing them up that productivity curve to drive a faster growth rate on the top line than we're seeing on the SG&A line.

Jared Oasheim: It's now pushing them up that productivity curve to drive a faster growth rate on the top line than we're seeing on the SG&A line. And that is our expectation, is that we're gonna continue to drive them up that productivity curve and continue to add new heads to see that growth rate reaccelerate in the coming years, but with-

Speaker #3: And that is our expectation is that we're going to continue to drive them up that productivity curve and continue to add new heads. To see that growth rate re-accelerate in the coming years.

Speaker #3: But with 86 million dollars of cash, it's not a concern for us.

Kevin Hykes: ... $86 million of cash, it's not a concern for us.

Speaker #5: Understood. Thank you.

Max Smock: Understood. Thank you.

Chase Knickerbocker: Understood. Thank you.

Speaker #6: Thank you. This concludes the question and answer session. I'd like to turn the call back over to Kevin Hykes for closing remarks.

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

Speaker #3: 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.

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. Thanks.

Speaker #3: Thanks.

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

Q4 2025 CVRx Inc Earnings Call

Request a DemoDemo

CVRX

CVRx

Earnings