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CVRx (NasdaqGS:CVRX) Q4 2025 Earnings call February 12, 2026 04:30 PM ET Company ParticipantsJared Oasheim - CFOKevin Hykes - President and CEOMike Vallie - Healthcare Investor Relations Managing DirectorConference Call ParticipantsChase Knickerbocker - Senior Equity Research AnalystFrank Takkinen - Senior Research AnalystJohn Young - Research AnalystLily Lozada - Research AnalystMax Smock - Equity Research AnalystNone - AnalystOperatorWelcome to the CVRx Q4 2025 Earnings Call. At this time, all participant ...

CVRx (NasdaqGS:CVRX) Q4 2025 Earnings call February 12, 2026 04:30 PM ET Company ParticipantsJared Oasheim - CFOKevin Hykes - President and CEOMike Vallie - Healthcare Investor Relations Managing DirectorConference Call ParticipantsChase Knickerbocker - Senior Equity Research AnalystFrank Takkinen - Senior Research AnalystJohn Young - Research AnalystLily Lozada - Research AnalystMax Smock - Equity Research AnalystNone - AnalystOperatorWelcome to the CVRx Q4 2025 Earnings Call. At this time, all participant ...

Financial Data and Key Metrics Changes - In Q4 2025, total revenue was $16 million, a 4% increase year-over-year, while full-year revenue reached $56.7 million, reflecting a 10% growth [3][17] - Gross profit for Q4 was $13.8 million, an 8% increase, with gross margin rising to 86% from 83% a year ago [19] - Net loss for Q4 was $11.9 million, or $0.46 per share, compared to a net loss of $10.7 million, or $0.43 per share in Q4 2024 [21] Business Line Data and Key Metrics Changes - U.S. revenue was $14.9 million in Q4 2025, a 4% increase, with revenue units totaling 478, up from 460 in the prior year [17] - European revenue increased to $1.1 million, a 10% rise, with revenue units growing to 49 from 41 [18] Market Data and Key Metrics Changes - The addressable market for Barostim therapy is estimated at $10.5 billion, with only 1% penetration, indicating significant growth potential [5] - The initiation of the BENEFIT-HF trial could expand the addressable market to approximately $30 billion if successful [12] Company Strategy and Development Direction - The company focused on three strategic priorities: building a world-class sales organization, driving deep adoption in targeted centers, and reducing barriers to adoption [6] - Transition to Category I CPT codes is expected to improve patient access and reimbursement predictability, effective January 1, 2026 [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sales team's ability to execute and drive growth, despite a natural ramp-up period for new sales representatives [6][15] - The company anticipates total revenue for 2026 to be between $63 million and $67 million, with a gross margin of 84% to 86% [23] Other Important Information - The company amended its debt facility to extend the maturity date to 2031 and increase access to additional capital [14][22] - A new Chief Human Resources Officer was appointed, indicating ongoing organizational development [16] Q&A Session Summary Question: On the BENEFIT-HF trial strategy and revenue generation - Management indicated that the trial will involve a mix of existing and new commercial sites, with expected revenue from approximately 1,600 to 1,700 devices sold during the trial [26][28] Question: Growth of active accounts in Q4 - Management noted that while there was a net addition of accounts, the focus remains on deepening existing relationships, with expectations of adding around three active territories quarterly in 2026 [30][31] Question: Impact of the Category I code on treatment barriers - Management reported positive early signs of improved prior authorization approvals and expects this trend to continue as the transition progresses [36][39] Question: Path to profitability and cash management - The company has sufficient cash reserves and access to additional capital, with a focus on driving sales productivity to achieve profitability [72][74]

Core Insights - CVRx, Inc. has initiated the BENEFIT-HF clinical trial, a significant randomized study aimed at evaluating the impact of Barostim in a larger heart failure population [1][3] - Barostim is an implantable device that enhances baroreflex signaling to improve heart failure symptoms and has been commercially available since FDA approval in 2019 [2] - The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials, randomizing 2,500 patients with a primary endpoint focused on all-cause mortality and heart failure decompensation events [3] Company Developments - If successful, the BENEFIT-HF trial could potentially triple the indicated patient population for Barostim, broadening access to this heart failure management approach [4] - Analyst commentary suggests that the trial's success could significantly increase the company's total addressable market (TAM) and attract more attention within the cardiology community [5] - The trial's design includes CMS coverage, which is seen as a key milestone that could unlock additional revenue potential, with an estimated $50 million in top-line revenue from Barostim therapy for approximately 1,650 patients [5] Market Reaction - Following the announcement, CVRx shares experienced a notable increase of 15.93%, reaching $7.60 [6]

Core Insights - CVRx, Inc. has initiated the BENEFIT-HF clinical trial, which is expected to be one of the largest therapeutic cardiac device trials for heart failure, supported by CMS Category B IDE coverage [1][4][5] - The trial aims to evaluate the Barostim™ device in a significantly expanded heart failure population, potentially tripling the indicated patient population for the device [3][5] Company Overview - CVRx, Inc. is a medical device company focused on developing innovative neuromodulation solutions for cardiovascular diseases [6] - Barostim™ is the first FDA-approved medical technology that uses neuromodulation to alleviate heart failure symptoms, receiving FDA Breakthrough Device designation in 2019 [2][6] Clinical Trial Details - The BENEFIT-HF trial will randomize 2,500 patients across approximately 150 centers in the U.S. and Germany, with the primary endpoint being a composite of all-cause mortality and heart failure decompensation events [3] - Enrollment for the trial is expected to begin in the first half of 2026 [3] Patient Population Criteria - The trial will include patients who remain symptomatic after receiving optimized guideline-directed medical and device therapies, have a left ventricular ejection fraction (LVEF) <50%, and NT-proBNP levels <5,000 pg/mL [7]

CVRx Conference Call Summary Company Overview - **Company**: CVRx - **Industry**: Medical Technology (MedTech) - **Product**: Barostim, an autonomic neuromodulation therapy for heart failure treatment - **Market Size**: $10.5 billion prevalence-based market for heart failure treatment [3][6] Key Points and Arguments Heart Failure Market Dynamics - Heart failure affects approximately 6.7 million Americans, leading to over 1 million hospital discharges and emergency room visits annually, with costs projected to reach nearly $70 billion per year by the end of the decade [3][4] - Current treatment involves a combination of four drugs (quad therapy), which only 1% of patients reach optimal dosages, and over 40% discontinue within the first year [5][6] - Patients prioritize quality of life over longevity, indicating a significant unmet need for effective therapies that improve daily living [6][12] Barostim Therapy - Barostim targets the neurohormonal pathway, addressing the root cause of heart failure by restoring signaling to the brain, thus reducing the toxic effects of neurohormones [9][10] - The therapy has shown a 68% improvement in functional status and a 94% response rate in clinical outcomes [11][12] - The BeAT-HF trial demonstrated significant improvements in quality of life and exercise capacity, with a positive signal in all-cause mortality [12] Commercial Strategy - CVRx aims to establish Barostim as the standard of care through improved salesforce productivity, deep adoption in targeted centers, and addressing barriers to therapy adoption [13][21] - The company has transformed its salesforce, focusing on mentoring and training to enhance productivity [13][15] - Building networks of aligned stakeholders, including clinical and financial champions, is crucial for deeper adoption [16][17] Barriers to Adoption - Key barriers include awareness, evidence, and patient access [21][30] - The implementation of Category 1 codes has improved reimbursement processes, increasing confidence among physicians regarding patient coverage [30][31] - The company has seen a 46% approval rate for Medicare Advantage within 30 days, a significant improvement from previous years [32][46] Financial Performance and Projections - Q4 2025 worldwide revenue was approximately $15.9-$16.1 million, with a total for the year of $56.5-$56.7 million, reflecting an 11% growth rate [33] - For 2026, projected revenue is between $63 million and $67 million, with gross margins of 84%-86% [33] - The company anticipates a cash burn of $35-$40 million for 2026, with a focus on achieving cash flow break-even through increased sales productivity [38][41] Future Opportunities - The BenefitHF trial, a landmark randomized controlled trial, aims to expand the indication for Barostim, potentially tripling the total addressable market from $10 billion to over $30 billion [25][27] - The trial will enroll 2,500 patients and is expected to begin later this year, pending CMS approval [26][29] Conclusion - CVRx is positioned to significantly impact the treatment of heart failure, addressing a critical unmet need and improving the quality of life for many patients [34] - The company is focused on executing its strategy to drive adoption and achieve sustainable growth in the coming years [35][49]

Market Opportunity & Prevalence - The prevalence-based market opportunity for Barostim is estimated at $10.5 billion in the U S HFrEF market[8, 9] - Heart failure affects nearly 6.7 million adults in the U S [10] - The company is less than 1% penetrated into its addressable market[36] Clinical Efficacy & Safety - Barostim implantation has a 97% freedom from major complications rate[54, 56] - Barostim shows a clinically relevant 94% response rate[58] - Real-world evidence demonstrates an 85% relative reduction in hospital visits per year post-Barostim implant (average 1 92 years) compared to pre-implant (12 months)[67, 68] Financial Performance & Guidance - Preliminary Q4 2025 worldwide revenue is $15 9–$16 1 million[104] - Preliminary 2025 worldwide revenue is $56 5–$56 7 million, with a gross margin of 84%-86%[104, 105] - The company expects total revenue between $63 0 million and $67 0 million for the full year of 2026[108] Growth Strategy - The company's strategy focuses on improving salesforce productivity, driving deep adoption in targeted centers, and addressing barriers to adoption[70, 71] - The company is focusing therapy awareness efforts on the clinicians and patients that surround targeted centers[84] - The company has received IDE approval for BENEFIT-HF, a potential landmark randomized controlled trial (RCT) in HF, with a trial size of 2,500 patients[94, 95]

Core Insights - CVRx, Inc. has transitioned to Category I Current Procedural Terminology (CPT) codes for its Barostim device, effective January 1, 2026, replacing the previous Category III codes, which is expected to enhance adoption, coverage, and reimbursement for the therapy [1][2][3] Company Overview - CVRx, Inc. is a commercial-stage medical device company that specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - The Barostim device is the first FDA-approved medical technology that utilizes neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim functions by delivering electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] Regulatory and Market Impact - The new Category I CPT codes are anticipated to provide more predictable and consistent reimbursement for healthcare professionals and patients using Barostim therapy [3] - The Barostim device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as being compliant with EU Medical Device Regulation and holding CE Mark approval for heart failure and resistant hypertension in the European Economic Area [3]

CVRx Conference Call Summary Company Overview - **Company**: CVRx - **Industry**: Cardiovascular medical devices - **Product**: Barostim, a neuromodulation therapy for heart failure - **Annual Total Addressable Market (TAM)**: $2.2 billion [1][5] Key Points and Arguments Heart Failure Market - Heart failure leads to over 1 million hospitalizations, 1.3 million emergency room visits, and 8 million physician office visits in the U.S. annually, with spending projected to reach approximately $70 billion by the end of the decade [1] - Heart failure is a progressive disease with significant mortality rates, exceeding those of the top five cancers [1] Treatment Landscape - Current treatment involves quad therapy (four Class I drugs), but only 1% of patients reach therapeutic doses, and 40% discontinue at least one drug within the first year [3] - Patients express a preference for a higher quality of life over mere life extension [4] - Barostim targets the "forgotten middle" of heart failure patients, aiming to restore quality of life [4] Clinical Evidence and Efficacy - Barostim has shown a 68% improvement in New York Heart Class functional status and a 94% response rate among patients [10] - A real-world study indicated an 85% reduction in hospitalization rates post-implantation of Barostim [11] - The therapy operates by restoring signaling from baroreceptors to the brain, effectively reducing sympathetic tone and neurohormonal toxicity [8][9] Go-to-Market Strategy - CVRx is focusing on building a specialized sales organization and deepening adoption in targeted accounts rather than broad distribution [12][13] - The company has identified 300-400 centers in the U.S. with the highest potential for Barostim adoption based on patient volume and experience with similar devices [15][16] Barriers to Adoption - Key barriers include therapy awareness, clinical evidence, patient access, and reimbursement issues [18][19] - Significant outreach efforts are being made to educate referral physicians and advanced practice providers [20] Reimbursement Developments - Secured a permanent inpatient DRG reimbursement of $43,000 and an outpatient code at $45,000 [24] - Transitioning to a permanent category one procedural code on January 1, which will enhance payment certainty for surgeons and reduce prior authorization denials [25][26] Financial Performance - Reported Q3 revenue of $14.7 million, with guidance for Q4 revenue between $15 million and $16 million [27] - Gross margin reported at 87%, with a cash balance of $85 million [27] Additional Important Information - The therapy has a remarkable 97% freedom from complications during implantation [9] - The company is actively generating further clinical evidence to support the therapy's efficacy and safety [21][22][23]