CVRx, Inc.

Greetings and welcome to the CVRX Q1 2026 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Vallee from ICR Healthcare. Thank you. You may begin.

Good afternoon. Thank you for joining us today for CBRX's first quarter 2026 earnings conference call. Joining me on today's call are the company's president and chief executive officer, Kevin Hikes, and chief financial officer, Jared O'Shine. 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 CBRX's President and Chief Executive Officer, Kevin Hikes.

Thanks, Mike. Good afternoon, and thank you for joining our first quarter 2026 earnings call. We delivered a strong start to 2026, exceeding the high end of our guidance range, driven by 22% growth in the United States. The investments we made throughout 2025 are beginning to positively impact our results. Last year, we worked deliberately to strengthen our sales organization, refine our go-to-market approach, advance critical reimbursement initiatives, and to secure approval for our landmark clinical trial. This quarter shows early evidence that the foundation we have built is translating into results. As we move through 2026, we remain focused on executing against the same three strategic priorities that have guided our work to date. Building a world-class sales organization, driving deep adoption in targeted centers, and continuing to reduce the barriers to adoption of barostem therapy. Starting with our sales organization, we're pleased with the progress we're seeing from the team. We're seeing meaningful contributions from a broader and more experienced sales team, reflecting the quality of talent we've been able to attract, the discipline we've brought to onboarding and training, and the program-focused selling approach that the team is increasingly comfortable executing. We continue to expand both our active implanting center base and our territory footprint during the quarter, and we expect to maintain this cadence of expansion through the balance of the year. Our second priority is driving deep adoption in the centers we've targeted. Our program-focused playbook emphasizes intentional targeting, building a redundant network of clinical and administrative stakeholders, and establishing a defined barostim workflow. In the accounts where all of these elements are in place, we're seeing barostim becoming part of how heart failure is routinely managed, rather than an episodic consideration, resulting in higher utilization. This remains the foundation for the long-term growth of our business. Our third priority is continuing to address the three fundamental barriers to the adoption of barostim therapy, patient access, therapy awareness, and clinical evidence. We made meaningful progress on all three fronts in the first quarter. Starting with patient access, the transition to Category 1 CPT codes, which took effect on January 1st, is the most significant reimbursement advancement in our company's history, and we're already beginning to see its impact. Our 30-day Medicare Advantage prior authorization approval rate for submissions managed by our in-house market access team was 46% for the first quarter of 2026, as compared to 31% in 2024 and 44% in 2025. Within the quarter, our approval rate was 50% through the first two months before declining in March. While we are encouraged by the underlying year-over-year improvement tied to the new Category 1 code, the March softening reflects the impact of simultaneous changes in the broader reimbursement environment that are affecting our company and others across the medical device industry. Effective January 1st, new regulations require Medicare Advantage payers to respond with a decision to a prior authorization request within three or seven days depending on urgency. as compared to the previous 14-day requirement. As a result, certain payers implemented new automated review processes beginning in late February in response to these compressed timeline requirements. This has resulted in a higher rate of initial denials, particularly in March, on the basis of an experimental designation, even for therapies with established Category 1 codes and well-documented clinical evidence. Importantly, this is not a reflection of a change in the clinical or coverage rationale for barostim. This is a new administrative dynamic that is being seen broadly across the device industry, which is not unique to our therapy. We believe that this is simply a timing issue and not a change to the ultimate approval rates, because when our market access team appeals these decisions with additional clinical documentation, most of the initial denials are overturned successfully. While the underlying coverage position for barostim has never been stronger, our goal is to adapt to this changing environment and to ensure that every submission meets this increasing administrative scrutiny on the front end. Our market access team is implementing this approach with patients and providers through our in-house prior authorization service, as well as supporting physician practices with their independent prior authorization efforts to ensure that they effectively navigate this changing environment. We believe the long-term trajectory for patient access remains strongly positive, and we expect these payer processes to continue to normalize as the industry adjusts to the new regulatory framework. As it relates to therapy awareness, we continued to expand our medical education efforts during the quarter, with a particular focus on the advanced practice providers who manage most of our indicated heart failure patients in the community. We also had a meaningful presence at several important cardiology meetings during the quarter, including multiple presentations at the THT and ACC meetings that reflect the growing body of clinical evidence supporting barostim. These engagements continue to drive strong interest in barostim therapy among the clinicians who are best positioned to identify candidates for treatment. Additionally, shortly after the first quarter, we piloted our first educational symposium focused on nurses in community cardiology practices, extending our outreach beyond advanced practice providers to the registered nurse coordinators who also play a key role in managing heart failure patients in the community. In terms of clinical evidence, the recently initiated BenefitHF trial is a landmark randomized controlled trial evaluating barostim in an expanded population of heart failure patients with ejection fractions up to 50% and NT-Pro BNP levels up to 5,000. If successful, this trial would expand our prevalence-based addressable market from approximately 339,000 patients today to over 980,000 patients, effectively tripling our market opportunity to approximately $30 billion. I'm pleased to share that we activated the first site in our benefit HF trial in the first quarter and enrolled our first patient last week. The feedback from the heart failure community on the rigor and scale of the trial design has been very positive. Beyond the clinical objectives of the trial, we're seeing meaningful engagement from centers that are interacting with us for the first time because of Benefit HF, which we believe will contribute to broader awareness and visibility for barostem therapy. To wrap up, the first quarter reflects positive momentum across every part of our business. Our sales team is executing, the reimbursement environment is improving, and our clinical evidence program is advancing on schedule. We remain focused on continuing to execute through the balance of 2026, and we're confident in the path ahead. Now, I'd like to turn the call over to Jared for a financial review.