Shockwave Medical, Inc.

Good afternoon and welcome to Shockwave's fourth quarter and full year 2022 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 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, Isaac Zacharias, President and Chief Commercial Officer, and Dan Puckett, Chief Financial Officer. Earlier today, Shockwave released financial results for the quarter and year ended December 31st, 2022. A copy of the press release is available on the Shockwave website. Before we begin, I would like to remind you that management will make forward-looking statements during this call. within the meaning of federal securities law, 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, Future product development and approvals and the closing of our acquisition of NEOVAC are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events, such as the COVID-19 pandemic, that could cause actual results or events to materially differ from those anticipated or implied by these 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 sections on our annual report and Form 10-K on file with the SEC and available on EDGAR and in our other reports filed 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 16, 2023. 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 2022. Our Shockwave team delivered another strong quarter and an outstanding year with many important achievements. To highlight just a few of our key accomplishments in 2022, We had two new products approved in the US, demonstrated superiority in one-year follow-up in the PAD3 randomized trial, added regulatory shipping approvals in 12 new countries, including Japan and China, launched over 500 coronary accounts in the US, had several wins in reimbursement across the globe, and broke ground on a new manufacturing facility in Costa Rica. We achieved record quarterly revenue of $144 million in the fourth quarter of 2022, which was more than a 70% increase from the fourth quarter of 2021. This brought our revenue for the year to $490 million, more than doubling our revenues from 2021. What we found most encouraging about these results was the growth and contribution across all product lines and geographies. Our fourth quarter 2022 revenue versus fourth quarter 2021 revenue was up over 60% for U.S. coronary, was up over 90% for U.S. peripheral, and up over 70% for our international business. Rather remarkable across the board. Later in the call, Isaac will share some additional insights from the commercial side of the business, and then Dan will provide some details around our financial results. But I'd like to start with a few updates on recent activity here at Shockwave. We are pleased to have been granted FDA approval for our C2 Plus coronary product in mid-December, which was much sooner than we expected, as our regulatory team continues their trend of efficient approvals. As a reminder, C2 Plus adds 50% more pulses, going from 80 to 120. The experience in the European limited launch gives us high confidence in the performance of C2 Plus, and we plan to launch in the U.S. in the second half of this year. This is the first in a series of new coronary products that we plan to launch with the expectation that each new product will improve customer experience, expand IVL utility and, by extension, further increase coronary penetration. We are obviously pleased that reimbursement for coronary IVL in Germany was increased on January 1st of this year. Germany has the largest number of PCIs in all European nations at approximately 330,000 per year. Yet penetration of coronary IVL has been appreciably lower than in other large European markets, largely because of funding gap for IVL procedures. We believe the increases in reimbursement will meaningfully reduce the principal barrier to IVL utilization in Germany. We're presently working to double the size of our German team in order to support anticipated market expansion. We've been receiving great feedback on our L6 peripheral catheter, which is currently in limited launch in the U.S., As you may remember, this catheter was purpose-built to address resistant, dense calcium in large vessels. The limited launch has been going very well and has given us great insights. Isaac will provide a bit more color later in the call. We hosted multiple well-attended events during the fourth quarter, including at both VIVA and VEATH. We also shared updates from our PAD3 observational study at both of these conferences. We look forward to sharing more IVL data at CRT next week. where there are six sessions highlighting IVL, including further discussions on nodular calcium, as well as a presentation on our Empower female study design. It should be another great showcase for IVL. As you may have seen, late in January, the Society of Cardiovascular Angiography and Intervention, or SCIE, published updated guidelines which included coronary IVL as a treatment option in all U.S. cath labs, including ASCs, regardless of surgical backup status. Previous guidelines restricted recommended treatment to facilities with on-site surgical backup. We believe this is a great endorsement of the safety of IVL. Our C2 launch in Japan commenced in earnest in January. With appropriate reimbursement now in place, we have confidence that we can launch C2 very effectively. Isaac will provide a bit more color later in the call. And while the launch is just getting started, we are generally encouraged thus far. Lastly, earlier in January, we announced that we entered into a definitive agreement to acquire Neovask. And our enthusiasm for the reducer system's potential has grown post-announcement, largely because the clinical community responded even more positively than we had anticipated. This unique product has the potential to elegantly address a very large population of patients who currently do not have a treatment option for their debilitating refractory angina. The acquisition of Neovask, which is set to close by the end of this quarter, is a solid step in Shockwave's strategic mission to leverage the talents of our world-class team to develop and commercialize a steady cadence of novel technologies for underserved patient populations. Before I turn the call to Isaac, I will reiterate, as we shared in our call last month, That we anticipate delivering top-line revenue in the range of $660 to $680 million for the full year 2023, representing growth of 35% to 39% from 2022. With that, I'll turn the call over to Isaac, and then Dan will share more details on the broader business and financial results. Isaac?