CVRx, Inc.

Greetings and welcome to the CVRX Q2 2023 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should 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 Valli. Thank you, Mike. You may begin.

Good afternoon. Thank you for joining us today for CBRX's second 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 Oshine. 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-Q that will be filed with the SEC. I would now like to turn the call over to CVRX's President and Chief Executive Officer, Nadeem Yared.

Thank you, Mike, and thanks to everyone for joining us. I'll begin today's call by providing an overview of our second 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 thrilled to share that we had another excellent quarter. The nearly 120% year-over-year growth that we delivered in the U.S. exceeded our expectations and is highlighted by the strength in volumes, the expansion of the new U.S. active implanting centers, and the development of our new customer pipeline. Importantly, we are continuing to receive very positive feedback from physicians regarding their own experience when using our barostem therapy on their patients. Our financial performance continues to demonstrate the quality of the BetterStim procedure, the robust demand for BetterStim in the market, and our ability to execute. Now, let's dive into the details of our performance during the quarter. Worldwide revenue was $9.5 million, an 89% increase over the second quarter of 2022. This was primarily due to the continued execution within our U.S. heart failure business, which grew by 119% over the prior year. These results came from the ongoing utilization of BarroStem within our existing customer base, our successful expansion into new territories, and the elevated physician and patient awareness. We are encouraged that following our February announcement of the preliminary results of the BEAT-HF trial, adoption and utilization of Peristem has continued to grow. In each of the four months following that announcement, the business has been strong and physicians have seen the data at scientific meetings have had positive reactions. turning to an update on our operational progress during the second quarter. As a reminder, our focus areas are the continued expansion of our commercial infrastructure and the expansion of our clinical body of evidence. starting with a continued expansion of our commercial infrastructure. As expected, we added three new U.S. sales territories, bringing the total to 32. The talent we have been able to attract and put into the field is impressive, and we look forward to continuing to leverage their abilities to educate and train physicians and healthcare providers on Barrister. Also, during the second quarter, we further progressed our marketing initiatives, including our direct-to-consumer and patient education programs, which we will continue to optimize to support our commercial strategy. Moving to our second focus area, the expansion of our clinical body of evidence. As announced in June, we submitted a PMA supplement to FDA, which included data collected as part of the post-market BEAT-HF study. As a reminder, the PMA supplement is seeking a potential label expansion for barostim in line with the recommendation of the Executive Steering Committee of the BEAT-HF trial. We fully agree with the committee's assessment that the totality of evidence strongly supports barostim as a safe and effective treatment option for heart failure. We are currently undergoing the normal review process with FDA and expect to receive a response from FDA by the end of the year. We remain committed to closely monitoring the progress and will provide updates when we have significant developments to share. One last update. CMS recently released the proposed outpatient prospective payment system, or OPPS for short, for 2024, along with a proposed physician fee schedule for the same period. Of particular note was the absence of any mention of our March submission requesting assignment to one of the new technology APC payment codes as our transitional pass-through additional payment expires at the end of 2023. We anticipate submitting formal comments on the proposed OPPS package and advocate for inclusion in the final document later this year. However, Please remember that our base case for 2024 is the status quo, which would lead to a reduction in our expected average selling price across the US to approximately $26,000. This has been the assumption in our model that is guiding us to be able to reach cash flow breakeven without the need to complete an equity financing. We are very excited about what we have been able to accomplish during the second quarter and throughout the first half of 2023. Through the first six months of the year, we have grown our U.S. heart failure revenue by 124% as compared to 2022. We look forward to continuing to build on this momentum for the balance of the year, and I want to thank our team for their dedication to our mission of improving the lives of patients suffering from heart failure. I'll now turn the call over to Jared to review our financials. Jared?