CVRx, Inc.

We stand by. We're about to begin. Good afternoon, ladies and gentlemen. Welcome to today's CBRX Q2 2025 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during our question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone. Also, today's call is being recorded, and if you should need any operator assistance during the call today, please press star zero at any time. Now, at this time, I'd like to turn things over to Mr. Mike Vallee with ICR. Mr. Vallee, please go ahead, sir.

Good afternoon. Thank you for joining us today for CBRX's second quarter 2025 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 Heights.

Thanks, Mike. Good afternoon and thank you for joining us for our second quarter earnings call. We delivered total revenue of $13.6 million in the second quarter, a 15% increase over the same quarter last year. U.S. heart failure revenue was $12.2 million. We ended the quarter with 240 active implanting centers in the United States, up from 227 at the end of Q1 2025 and 189 at the end of Q2 2024. We also expanded to 47 US sales territories, up from 45 at the end of Q1. Our Salesforce transformation is proceeding according to plan. We are largely through the necessary transitions in the sales team that we initiated in Q4, and turnover is returning to normal. Importantly, we have aggressively hired since January to fill the open roles with strong talent. While we are enthusiastic about the team in the field, They are still early in their tenure, with more than 35% of territory managers hired since January 1. In addition, over half of our area sales directors have joined in the last 12 months, and all of them bring a significant level of management experience to this team. Overall, the quality of the talent that we've attracted has been exceptional, and these new reps and sales leaders are developing their expertise in our technology and clinical data and becoming increasingly comfortable in their regions and territories. As we near the end of the Salesforce transformation and as turnover returns to normal, we are shifting our focus from hiring to further optimizing our onboarding and training as we seek to increase the productivity of these new territory managers. We expect territory expansion to resume as territory managers hired early this year become increasingly productive. In parallel, we're seeing encouraging results from our refined approach to developing sustainable barrow stim programs. Our strategy of targeting centers based on indicators of potential and applying best practices is showing positive signs of traction and is evolving as we gain deeper insights into what makes accounts successful. We've observed that in some instances, the right combination of clinical champion and administrative support may matter as much as heart failure patient volume or new technology adoption history alone. While we are still primarily focused on adding Tier 1 and 2 accounts, Some of our most promising recent successes have been with centers that don't qualify as Tier 1 or 2 centers under our current segmentation model. For example, some centers in lower tiers act as satellite centers beneath a Tier 1 flagship and can serve as a future path into the flagship account. In addition, some centers that were excluded from our segmentation because they were not CardioMEMS adopters in the past can in fact be good opportunities for Barostim with the right clinical champion and administrative support in place. While our initial segmentation approach will continue to serve as a valuable guide, we will opportunistically add Tier 3 and 4 accounts where we are convinced that they can develop a successful Barrowston program. We're identifying the right combination of clinical champions and administrative partners within these accounts and expanding our network to include multiple prescribers per center as well as relationships with referring physicians and advanced practice providers in the surrounding community. The compensation plan that we implemented earlier this year encourages these program-building behaviors and is effectively driving the desired results across the team. The early results of our go-to-market strategy are encouraging. An increasing number of centers are meeting multiple, if not all four criteria for qualifying as a sustainable Barrel Sim program. Our approach to Dabbler accounts remains unchanged. We're making strategic decisions about where to invest resources, either working with underperforming accounts that have the potential to become sustainable programs or stepping back where the opportunity is limited. This account cleanup helps our utilization and lets our team focus their efforts on accounts where they can have the greatest impact. Our reimbursement strategy continues to advance, reducing one of the main barriers to adoption for this therapy. First, CMS has proposed maintaining the assignment of the barostim implant procedure to New Technology APC 1580 with its associated payment of approximately $45,000 for procedures performed in the outpatient setting. For the second year in a row, CMS is soliciting comments about the need for a level six neurostimulator APC. We expect CMS will publish the 2026 Medicare outpatient payment system final rule in November, and it will take effect on January 1, 2026. Second, the transition to Category 1 CPT codes in January of 2026 represents a significant milestone that will directly benefit our commercial efforts. The proposed Medicare physician fee schedule, released July 15th, specified 11 work RVUs for the barostim implant procedure, translating to a national average physician payment of approximately $550, consistent with our expectations. Overall, the transition to a Category 1 code will eliminate the experimental and investigational denials regularly seen with Category 3 codes, improve prior authorization predictability, and ensure that physicians are paid fairly and consistently for the procedure. These reimbursement updates follow the positive development of October 1, 2024, when BarroStim was assigned to a higher paying MS-DRG for inpatient procedures. Together, these three reimbursement improvements over the past nine months underscore the value of BarroStim and reinforce its role in the heart failure care continuum. Moving to our clinical strategy, Our clinical evidence generation efforts are gaining momentum on multiple fronts as we continue building the robust data foundation necessary to support barostim's adoption as a standard of care. Our discussions with FDA on a category B IDE randomized controlled trial design are progressing. The proposed trial would include patients with an ejection fraction of up to 50% and an NT-proBNP up to 5,000. Assuming we reach agreement with FDA on a trial design, we will then approach CMS to seek coverage for the procedures performed in the trial on Medicare patients, as this coverage is a prerequisite for moving forward with the trial. As appropriate, we will provide additional updates. Beyond the randomized controlled trial, we continue to develop additional clinical evidence through investigator-sponsored research, multicenter trials, and real-world data. This directly supports our commercial efforts by strengthening the foundation of evidence to support physician adoption of the therapy. This further demonstrates our continued commitment to advancing the science behind baroreceptor neuromodulation. As a reminder, our final area of focus is on building awareness of barostim. We continue to implement these efforts through a variety of educational programs at the local, regional, and national level with physicians and advanced practice providers, or APPs. We increased our focus on APPs starting in Q1, with over 100 educational programs being completed year to date. These events are driving strong interest and awareness in barostim therapy from community-based APPs who manage most of our indicated heart failure patients on a day-to-day basis. We believe these efforts are meaningful in moving barostim towards standard of care, given that these providers are instrumental in managing potential barostim patients in the community. We are looking forward to attending the Heart Failure Society of America meeting this September, one of the most important heart failure meetings of the year, which gives us a great opportunity to connect with key opinion leaders and physicians and to continue to raise awareness of barostem therapy. To wrap up, we delivered a solid second quarter with revenue growth in line with our guidance and expectations. Our work to transform the sales force is progressing well, and we're building momentum in the development of sustainable barostem programs. The positive developments in reimbursement and clinical evidence set us up well for continued growth in the future. Now, I'd like to turn the call over to Jared for a financial review.