Shockwave Medical, Inc.

Good afternoon, and welcome to Shockwave's first quarter 2022 earnings conference call. At this time, all participants are on 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 Shockwave, for 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, Isaac Zacharias, Chief Commercial Officer, and Dan Puckett, Chief Financial Officer. Earlier today, Shockwave released financial results for the quarter ended March 31, 2022. 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 developments 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 these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors 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 9, 2022. 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 2022. While the quarter started out slowly with a fairly significant COVID surge, Omicron now seems like a distant memory as procedures recovered steadily since January. Our team has remained focused, which has enabled us to sustain our high level of performance, as evidenced by our first quarter revenues of $93.6 million, a 194% increase from the first quarter of 2021. At a high level, U.S. Coronary continues to account for the majority of our growth. However, both our international business and our U.S. peripheral franchise continue to be strong contributors to growth. Later in the call, Isaac will provide additional details regarding market dynamics, but first I would like to discuss some key recent accomplishments and drivers of our business. Starting with peripheral, There has been increasing attention paid to our business of late, and we are encouraged that the significant upside potential of this franchise is being better appreciated. Last month, we announced the transition from a limited to a full launch of M5 Plus product, and the customer response continues to be very positive. As a quick reminder, the M5 Plus, which will replace our legacy M5 product over time, has three major improvements, size, reach, and speed. By now offering a larger 8-millimeter version, doctors are noting that they feel better equipped to treat a significant portion of the iliac arteries where our 7-millimeter device felt a bit undersized to them. The longer catheter shaft gives our customers the length they need to reach lesions above the knee via radial access from the wrist, which our old shaft length could not quite accommodate. And lastly, by doubling the speed of the pulses from 1 to 2 per second, The procedure takes half the time, and no one wants to go back to the old version once they've done one case with M5 fast. Size, reach, and speed are all resonating strongly during the early days of the launch, and confirms that our team is doing an excellent job at identifying the needs of our customers and incorporating them efficiently into our new product development efforts. The big news on the international front is the recent approval of Coronary IVL in Japan. There are over 250,000 PCIs performed in Japan each year, and physicians there perform intravascular imaging, particularly IVUS, on almost all their cases as standard practice, which enables them to identify calcium more accurately than relying on x-ray. By comparison, less than 10% of U.S. cases use intravascular imaging. As we have seen in every geography, our safety profile resonates strongly with the Japanese cardiologists, and remarkably, Our CAD4 study in Japan had even lower event rates than the very low rates we have seen in previous studies. So the combination of their use of intravascular imaging to better identify calcium and our consistently low adverse event rates are two of the many reasons why we anticipate that Japan will be amongst our strongest markets. Our leadership team in Japan is quite strong, and they are now in the process of building out our sales organization to ensure that we are poised and ready as soon as we receive reimbursement. which we believe should come by the end of this year. In order to help the clinical community appreciate the benefits of IVL, we continue to mine the substantial data sets we have created through the rigorous trials we have conducted. We were pleased to have two publications in the inaugural issue of the Journal of the Society for Cardiovascular Angiography and Interventions, or JSCI, which just launched in January. Featured in this issue were our CAD3 one-year results as well as our CAD pooled outcomes by gender. The gender studies have been particularly interesting and insightful as they have helped us to highlight the safety and effectiveness of IVL on frail patients with smaller vessels, as are generally found in female coronary patients. These data showed that IVL was equally safe and effective in men and women, unlike previous studies of atheroectomy devices. In February, CAD3 IVAS outcomes were presented at CRT, and shortly thereafter, in March, the CAD4 one-year outcomes were presented at the Japanese Circulation Society by Dr. Shigeru Saito, who was the PI of CAD4. We anticipate a continued healthy cadence of data being presented and published as our studies continue to prove the acute and long-term benefits of our technology. Finally, a few words on the macroeconomic and global environment. We believe the next several quarters will be more stable for our customers than the COVID whipsaws that they have lived through over the past two years. And our continued acceleration, as evidenced by the strong Q1 performance, suggests that we will likely deliver results in a higher range than our prior guidance. We now anticipate delivering top-line revenues in the range of $435 to $455 million for the full year of 2022, representing growth of 83% to 92%. from 2021. As our company has matured, we have increasingly made it a priority to be active in sharing our good fortune with those who are not as fortunate. Our philanthropic priority has recently shifted to supporting the people of the Ukraine as best we can. In addition to other Ukraine-specific donations, our team in Europe has partnered with our distributor in Poland and established a relationship with a hotel near the Ukrainian border whereby Shockwave is helping to fund the hotel as a temporary housing facility for Ukrainian refugees, almost exclusively women and their children. I've been so impressed by the outpouring of support from our employees across the globe to help personally and financially support this cause. The Shockwave team is not just extraordinary in the ability to pull together and deliver results, but it is extraordinary in the sense of purpose and community demonstrated by the individual team members. With that, I will turn the call over to Isaac to provide more color on the commercial front. Then Dan will share more details on the broader business and financial results. Isaac?