CVRx, Inc.

Good day, and thank you for standing by. And welcome to the CBRX Third Quarter 2021 Conference Hall. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 on your telephone. As a reminder, this conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mr. Mark Vallee with ICR Westwick. Please go ahead.

Good afternoon, and thank you for joining us today for CBRX's third quarter 2021 earnings conference call. Joining me on today's call are the company's president and chief executive officer, Nadim Yared, and its chief financial officer, Jared Osha. 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, Nadeem Murad.

Thank you, Mike, and thank you, everyone, for joining us this afternoon. I'll begin by providing an overview of our third quarter performance, followed by an operational update. Our CFO, Jared Oersheim, will then review our financial results. And then I will conclude with our thoughts for the balance of 2021 before turning to the question and answers. Starting with the review of the third quarter. Our total revenue was $3.4 million, an increase of approximately 240% over the third quarter of 2020. This growth was driven by continued strong performance in U.S. heart failure, which generated $2.5 million. Like most procedure-based companies, we were negatively impacted by the COVID-19 Delta spike experienced during the quarter. We have exposure to some of the hardest-hit regions of the country, including areas like Florida, Texas, and Georgia, and as a result, we saw a meaningful dip in procedures in August. However, that dip was offset by a strong September, which we believe benefited from both the traction of our commercial strategy as well as cases being shifted into September. As the spikes receded, we were able to get out into the field and interact with both new and existing customers, leading us to deliver our highest number of US implantations in a single day in our history. The strength in our US heart failure business also offset headwinds seen in our European business, which proved to rebound more slowly than in the US following the summer spikes. Overall, we are really excited with how the quarter ended and look forward to carrying this momentum forward. Turning to an operational update now. The expansion of our commercial infrastructure, particularly our direct sales team in the United States, is a significant component of our strategy to drive adoption. As anticipated, we added three U.S. territories in the third quarter, bringing the total to 11. We are very pleased with the level of talent we have been able to attract to the organization and continue to expect to add an additional three territories in the fourth quarter, bringing the total to 14. Another area of focus is the innovation of our product portfolio. In the last two months, we made three PMA supplement submissions with the FDA. The first was our successful testing results for BarroStim's MRI conditional labeling, which if approved, will allow MRI scanning with specific instructions for patients who have been implanted with BarroStim. While we do not believe that the addition of MRI compatibility will materially drive implant growth, We do believe it will give confidence to physicians to practice medicine in the ways they think is best for their patients. The second PMA submission was for our new implantable pulse generator, or IPG in short, which is smaller in size and has 20% longer battery life on average. And the third PMA submission was for our new programmer, which is tablet phone factor with an even simpler programming software. Approval for the three PMA supplement submissions is expected in the first half of 2022. Another long-term growth driver is the expansion of the clinical body of evidence. Our post-market study of BTHF A randomized controlled study designed to demonstrate the mortality and morbidity benefit of parastim in the HF-REF patient population remains on track. We continue to expect to accrue all the events needed for the final analysis by the end of 2022 and unblind the data in early 2023. Given some of the macro challenges experienced in the quarter, we are very pleased with where we ended up. We have continued the expansion of the commercialization of Perestim Neo and are incredibly excited about what we will accomplish as an organization by year end. While it is still early days, we are optimistic that we will build upon the momentum we saw late in the quarter and are confident in our ability to operate in this continually changing environment. And now I would like to turn the call over to Jared for a financial review.