CVRx, Inc.

Greetings and welcome to the CVRX fourth quarter 2023 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 during a conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Mike Vallee, Investor Relations for CVRX. Thank you. You may begin.

Good afternoon. Thank you for joining us today for CVRX's fourth quarter 2023 earnings conference call. Joining me on today's call are the company's president and chief executive officer, Nadeem Yared, and chief financial officer, Jared O'Shaun. The remarks today will contain forward-looking statements, including statements about financial guidance. The 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, including the upcoming Form 10-K that will be filed with the SEC. I would now like to turn the call over to CVRX's President and Chief Executive Officer, Nadim Yared.

Thank you, Mike, and thanks, everyone, for joining us. I'll begin today's call by providing an overview of our fourth quarter performance, followed by an operational update and a review of our financial results by our CFO, Jared Oshime. Then, I will conclude with our thoughts for the rest of the year before turning to Q&A. We are immensely proud of the achievements of our team in 2023. It's been an important year for CVRX, marked by significant progress in all our strategic initiatives, which have driven increased adoption and utilization of Parastim. This is reflected in our worldwide revenue, which has shown substantial growth, primarily attributed to the impressive 97% annual expansion in our US heart failure business. As we wrapped up 2023, we did so on a strong note, showcasing consistent and effective execution across various aspects of our business in the fourth quarter. This underscores our team's skill in accelerating the adoption of Peristem through our commercial and marketing efforts. Now, let's dive into the details of our performance. Starting with the review of the quarter, worldwide revenue was $11.3 million, a 58% increase over the fourth quarter of 2022. This was primarily due to the execution within our US heart failure business. The increase was primarily driven by continued growth as a result of the expansion into new sales territories and new accounts, as well as increased physician and patient awareness of Parastim, turning to an update on our operational progress during the fourth quarter. As a reminder, our focus areas for 2023 were the continued expansion of our commercial infrastructure and the expansion of our clinical body of evidence, starting with expansion of our commercial infrastructure. We've grown our commercial reach by adding three new sales territories in the United States, as expected, bringing our total to 38. We continue to add high-caliber talent, which we believe is due to the enthusiasm around BetterStem in the markets. Additionally, we've been making continued and consistent headway with our marketing efforts, including our direct-to-consumer and patient education programs. As we press forward, we continue to expect refining these initiatives to drive awareness among both patients and healthcare providers. Shifting to our second focus area, which is the growth of our clinical evidence, which has given both reimbursement and regulatory progress. In November, the Center for Medicare and Medicaid Services, CMS, reassigned BarroStem to New Technology APC 1580 with an average payment of $45,000, which went into effect on the 1st of January, 2024. As a reminder, in 2023, BarroStem was under the APC 5465 with an average payment of $29,000 plus the transitional path through payments. We believe that this reassignment to APC 1580 will make the BarroStem therapy more accessible for Medicare patients dealing with heart failure by simplifying the reimbursement landscape and ensuring fair reimbursement for facilities offering the procedure. In late December, The FDA approved expanded labeling for barostem by revising the instructions for use for barostem and incorporating key long-term clinical data from the BEAT-HF randomized clinical trial. The new labeling includes the following conclusion in the clinical section. In both premarket and postmarket phases, the primary safety endpoint was met and confirmed. The premarket phase showed positive results across all effectiveness endpoints indicating six-month improvements in six-month hall walk, quality of life, NYHA class, and NT-proBNP. The post-market phase effectiveness endpoint of cardiovascular mortality and heart failure morbidity was not met, but additional post-market phase analysis, such as the win ratio and freedom from all-cause mortality analysis, suggested the favorable effect of barostem therapy. The totality of six, 12, and 24-month data demonstrated symptomatic improvements for heart failure patients. All of this data is now included in the instructions for use and can be used by our sales team when educating physicians on our therapy. The updated indication statement in the instruction for use now specifies that BetterStim is indicated for patients who are NYHA Class 3 or Class 2 with a recent history of Class 3, despite treatment with guideline-directed medical therapies, who have a left ventricular ejection fraction of less than or equal to 35%, and an NT-proBNP less than 1600 picogram per milliliter. BarroStem delivers baroreflex activation therapy to improve patients' heart failure functional status, six-minute hall walk, and quality of life. As a result of these changes, we estimate that the U.S. annual market opportunity for BarroStem has increased to include patients considered by physicians based on this new long-term safety and efficacy data, as well as our commercial experience, and to account for the new reimbursement assignment for barostim. We believe the U.S. annual market opportunity is now $2.2 billion, or 76,000 new patients annually, as compared to our earlier estimate of 1.4 billion, or 55,000 new patients, representing increases of approximately 60% and 38%, respectively. I want to express my gratitude to all the patients, investigators, research teams, the executive steering committee, and FDA personnel who have supported our efforts in conducting this study over seven years, especially considering the challenges encountered during the COVID-19 pandemic. Looking back at 2023, it was a great year for CVRx. Throughout the year, we continued to support the growth of BetterStim in the United States through our commercial and marketing efforts, underscoring the benefits that BetterStim can provide to healthcare professionals and patients dealing with cardiovascular disease. The year wrapped up on a positive note, including the expanded BetterStim labeling and CMS's decision to reassign BetterStim to a new APC code. Before turning the call over to Jared, I want to address my decision to retire from CVRx. While there is never a perfect time for a leadership transition, the recent completion of BEAT HF, the expanded labeling, and the recent reimbursement decision, there is a window that now exists before the company embarks on the next phase of growth. I believe now is the right time to bring in a CEO who can build on the achievements of the company and steer CVRx to great success. I'm confident in CVRx's future given the proven benefits of Parastem therapy, our strong commercial traction, and our outstanding leadership team. The board and I are committed to a seamless transition, and I will continue in my current role until a new CEO is appointed. The board has engaged a leading executive search firm to assist in this process. I'll now turn the call over to Jared to review our financials. Jared?