CVRx, Inc.

Good day, and thank you for standing by. Welcome to the CBRX third quarter 2022 earnings conference call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising you that your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Mike Valley with CBRX. Please go ahead, Mike.

Good afternoon. Thank you for joining us today for CBRX's third quarter 2022 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 O'Shaughnessy. 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 CBRX's President, and Chief Executive Officer, Jadim Yared.

Thank you, Mike, and thanks to everyone for joining us today. I'll begin today's call by providing an overview of our third quarter performance, followed by an operational update, a review of our financial results by our CFO, Jared Oshime, and then I will conclude with our thoughts for the rest of 2022 before turning to questions and answers. Starting with the review of the third quarter, our total revenue was $6.2 million, an increase of 82% over the third quarter of 2021. These results were driven by the continued execution of our growth strategy in the United States and internationally. In the U.S., our heart failure business generated $4.9 million, approximately doubling the third quarter of 2021. This growth was due to positive impacts of our commercial expansion strategy supported by an increase in marketing and awareness campaigns. Now, for an update on operational development during the third quarter to support greater adoption and use of Parastem. Our focus areas are, one, the continued expansion of commercial infrastructure, two, innovation of our product portfolio, and three, the expansion of the clinical body of evidence. starting with the continued expansion of our commercial infrastructure. During the quarter, we added three new territories, bringing the total to 23. We continue to expect adding, on average, three new territories per quarter, targeting 26 territories by year-end. We are gaining traction with several of our marketing programs, including our direct-to-consumer pilot, the new branding campaign, and expanded patient education to prudently invest in new marketing initiatives, assessing the ROI of each before rolling them out more aggressively. Our second area of focus is innovation of our product portfolio. During the quarter, we officially launched our new implantable pulse generator, which is smaller in size than the prior generation and has 20% longer battery life on average, and our new programmer, which is a tablet form factor with an even simpler programming interface. We are excited about these upgrades as they highlight our commitment to bringing innovation to our customers. Our third focus area is the expansion of our clinical body of evidence. The BEAT-HF clinical trial is designed to demonstrate that Baristem provides a mortality and morbidity benefit additional to the reduction of symptoms of heart failure in patients with reduced ejection fraction. I am pleased to report that we recently accrued the required 320th event in the trial. We are now working to ensure that we have collected and monitored all events through that date so we can then unblind the data and begin to analyze it, which we believe will occur during the first half of 2023. We want to remind everyone that the post-market phase of the BEAT-HF trial has one primary endpoint, which is a composite endpoint that includes cardiovascular mortality, LVAD, heart transplants, and heart failure hospitalizations, and multiple potentially meaningful secondary and ancillary endpoints in pre-specified analysis. Our desired outcome from this post-market trial is an expansion of indication of barostem, We plan to submit to FDA the totality of the evidence and our corresponding analysis when we unblind the data. Based on our interpretation of the evidence and if it supports it, we plan to submit at that time our recommendation for an expansion of indication. However, the decision to modify the labeling is made by FDA based on their own analysis of the totality of the evidence and possibly by consulting with a panel of independent experts. As such, at this stage, It is near impossible to plan for a specific scenario as the totality of the evidence may provide a more nuanced outcome than a simple binary answer. This is the reason why, in our internal projections, we have relied on a conservative assumption that does not include any indication expansion based on the results of the trial, and any of the potential positive outcomes leading to indication expansion would be incremental to that model. Let me repeat that this is not because we are pessimistic about the outcome. No, but rather it is our attempt to be conservative in setting expectations for long-term growth. We also believe that the current reimbursement levels for barostim in the U.S. have been established based on the current indication of symptomatic treatment of heart failure. We continue to believe strongly in this therapy and what it is doing for patients. We are looking forward to seeing the totality of the evidence gathered in the post-market phase of this trial and sharing it with the treating physicians, with their patients, and with you. Turning to an update on our BATWIRE trial. With some of the macro disruptions experienced at hospitals during 2022, enrollment has been slightly slower than expected. We now expect to complete enrollment in 2024 rather than by the end of 2023. We remain enthusiastic about the prospects for this ultrasound-guided implant toolkit that will make the procedure even less invasive. We are pleased with the consistent commercial execution and expansion of Parastim, especially progress with our heart failure business in the US. I want to express my gratitude to everyone at CVRx for the outstanding work they do every day. I'll now turn the call over to Jared to review our financials. Jared?