Shockwave Medical, Inc.

Good afternoon and welcome to Shackwave's fourth quarter and year-end 2020 earnings conference call. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Debbie Castor, Vice President of Investor Relations at Shackwave, for a few introductory comments.

Thank you all for participating in today's call. Joining me today from Shockwave Medical are Doug Godschel, President and Chief Executive Officer, Isaac Zacharias, Chief Commercial Officer, and Dan Puckett, Chief Financial Officer. Earlier today, Shockwave released financial results for the quarter and year ended December 31st, 2020. A copy of the press release is available on Shockwave's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product development approvals are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of the COVID-19 pandemic, that could cause actual results or events to material differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place any undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factor section of our annual report on Form 10-K on file with the SEC and available on EDGAR and in our other reports filed periodically with the SEC. Shockwave disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 17, 2021. And with that, I'll turn the call over to Doug.

Thanks, Debbie. Good afternoon, everyone, and thank you for taking the time to join us to review Shockwave's results for the fourth quarter and full year of 2020. The past year was full of many significant challenges for Shockwave and all of us, despite the challenges put in front of us by the global pandemic. Obviously, the most significant recent achievement was the receipt of PMA approval for CT, our coronary device, and we'll speak to that in more detail. But before we do, it is worthwhile recounting some of the team's recent accomplishments. We reported 22.7 million in revenue for the fourth quarter and 67.8 million for the full year of 2020, representing increases of 59% and 58% respectively from the same periods in 2019. Both the U.S. and international franchises grew at over 50% for the year, which reflects the global appeal of IVL. In October, at TCT Connect, our CAD3 U.S. Coronary IDE study data were presented as a late-breaking trial, and it confirmed that the safety and effectiveness endpoints of the trial were met. In November, the primary endpoint of our randomized PADD3 study was also presented as a late-breaking trial, this time at VIVA. The investigators demonstrated that intravascular lithotripsy is superior to angioplasty in severely calcified peripheral artery disease. Earlier this month, Data from our CAD IV pivotal study in Japan were published, confirming safety and efficacy in a complex patient population. In early December, CMS announced the creation of four new codes that established specific payment for intravascular lithotripsy procedures performed in an outpatient setting in arteries below the knee, as well as eight new codes for IVL performed in ambulatory surgery centers. We grew our overall team by nearly 60% over the course of 2020, with the most substantial growth occurring in our U.S. field organization, which now numbers over 125 individuals. And we made meaningful progress on our R&D programs, which led to an acceleration of patent filings, and we ended the year with over 100 issued patents. Isaac is going to do a deeper dive into our commercial efforts, but before handing the call off, I want to provide a brief update on the COVID-19 situation as it relates to shockwave and the trends we are witnessing, which are largely consistent with what others have reported. U.S. peripheral and international coronary procedures tapered off through the fourth quarter as COVID restrictions were put in place and some patients elected to defer their treatment to avoid entering hospitals. Our business remained stable through the quarter and into January, despite the dip in procedures on a macro level, which we found encouraging as it indicates that we captured a higher share of the cases that were still being done. Thankfully, most signs indicate that we are coming out of the worst phase of the current virus surge, so we anticipate that elective procedures will recover steadily over coming weeks as ICUs continue to free up capacity. That said, it remains extremely hard to predict the trajectory and impact of the virus given the additional variables of vaccines and new variants. To provide some additional context on our commercial operations and C2 launch, I'm happy to hand the call to Isaac.