Shockwave Medical, Inc.

2021 Earnings Conference Call. At this time, all participants are in 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 Best Relations at Shockwave, for a few introductory comments.

Thank you all for participating in today's call. Joining me today from Shockwave Medical are Doug Gottschall, President and Chief Executive Officer of Isaac Zacharias, Chief Commercial Officer, and Dan Puckett, Chief Financial Officer. Earlier today, Shockwave released financial results for the quarter ended March 31, 2021. 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 and 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 those forward-looking statements. Accordingly, you should not place undue reliance on these statements. For 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, May 10, 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 first quarter of 2021. We were pleased to be able to share our preliminary expectations for the quarter a few weeks ago, and we look forward to discussing our final results as well as some more detail about our accomplishments during the quarter. I'll start with a brief recap. We reported $31.9 million in revenue for the first quarter of 2021, representing an increase of 110% from the same period in 2020. We received pre-market approval for use of IVL and coronary artery disease from the U.S. Food and Drug Administration and subsequently sold $6.6 million of Shockwave C2 devices in the U.S. during the quarter, which outpaced our internal projections. We announced that we had formed a joint venture with Genesis MedTech Group, an established Chinese entity whose management team has a solid track record of commercializing medical devices in mainland China. In late March, we submitted our Shonin application to PMDA for commercial approval in Japan. And more recently, we were pleased to see that CMS has proposed new technology add-on payment codes, or NTAP, for inpatient coronary procedures where IVL is used. On a macro level, we are confident that the solid early performance of C2 will continue and will enhance the growth of our peripheral business in the U.S., Our international customers are still navigating the COVID challenges, and we expect that the elective procedures outside the U.S. will remain damp in this quarter, potentially through the third quarter. While it is still early in this very dynamic launch, we believe the traction we are witnessing with C2 is sustainable, and as a result, our expectation is that we will generate between $195 and $205 million in revenue for the full year of 2021. This represents growth of 188% to 202% from our revenue for the full year of 2020. I'm going to hand the call to Isaac now to provide some additional color on our commercial progress, and then Dan and I will provide more detail on the broader business and financial results. Isaac. Thanks, Doug.