CVRx, Inc.

Greetings and welcome to the CVRX third quarter 2023 earnings call. At this time, all participants are in listen-only mode. A 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. I would now like to turn the conference over to your host, Mike Vallee from ICR Westwick.

Good afternoon. Thank you for joining us today for CVRX's third quarter 2023 earnings conference call. Joining me on today's call are the company's president and chief executive officer, Nadeem Yared, and its chief financial officer, Jared Oshun. 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 third quarter performance, followed by an operational update and a review of our financial results by our CFO Jared Oshheim. Then I will conclude with our thoughts for the rest of the year before turning to Q&A. We maintain positive momentum in the third quarter, building on the strengths we delivered during the first half of 2023. In particular, the performance within our U.S. heart failure business continued to surpass our expectations by growing by more than 90% in the quarter. This is a testament to our team's ability to accelerate adoption of Parastim through the increased scale of our commercial organization and our marketing and awareness efforts. Parastim therapy continues to gain traction And the feedback we receive from physicians and patients is very positive. Now, let's dive into the details of our performance. Starting with the review of the quarter, worldwide revenue was $10.5 million, a 70% increase over the third quarter of 2022. This was a direct result of execution within our U.S. heart failure business, which grew by 92%. over the prior year. These results were achieved through the increased utilization of Peristem among our existing customer base, the continued addition of new active implanting centers, the measured expansion of new sales territories in the U.S., and increased awareness among physicians and patients. As a result of our sustained top-line revenue growth stemming from our focused investments in high return on investment initiatives, in combination with the prudent management of our operating spend, we have seen a continued reduction in our cash burn rate. It is highly encouraging to see operating leverage grow. within our business, and we anticipate this trend to be sustainable as we move into 2024 and beyond. Turning to an update on our operational progress during the third 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 the expansion of our commercial infrastructure. We've expanded our commercial reach, adding three new U.S. sales territories as anticipated, bringing our total to 35. During the quarter, we also made progress with our marketing efforts, which included our direct-to-consumer and patient education programs. As we move forward, we will continue working to fine-tune these initiatives to drive increased awareness of patients and healthcare providers. Moving to our second focus area, the expansion of our clinical body of evidence, and in particular, on the regulatory front. Our ongoing interaction with FDA regarding our potential label expansion Following the post-market BEAT-HF data continues to progress as expected. FDA has provided us with their initial feedback, and we have responded to their questions. We continue to anticipate a potential decision by year-end. Now for an update on CMS and the proposed outpatient prospective payment system, or OPPS, for 2024. Earlier this year, we submitted a request to CMS to be assigned a new technology APC payment code as our transitional pass-through payment expires at the end of 2023. In August, the company presented before a CMS advisory panel and received a 5-0 vote in favor of mapping to the higher-paying code APC 1580, which reimburses approximately $45,000. While this is encouraging, it is important to note that this vote is non-binding. If CMS instead decides to map Baristim to APC 5465 without the transitional path through payment for 2024, which is the basis for the company's plans, then the average reimbursement to hospitals will be approximately $30,000. The final outpatient payment rule is expected to be published in late November. We are pleased with the accomplishments of the third quarter and the overall progress throughout 2023. Our performance has been consistently strong, largely driven by exceptional growth in our US heart failure business. We have steadily expanded our commercial reach and made strides in marketing and patient education. Our ongoing discussions with FDA and a positive vote from the CMS Advisory Panel in August are encouraging, though our guidance does not hinge on these outcomes. We remain confident in our business to help bring relief to many patients suffering from heart failure. I'll now turn the call over to Jared to review our financials. Jared?