Silk Road Medical, Inc.

Ladies and gentlemen, thank you for and welcome to Silk Road Medical's 2022 second quarter earnings conference call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. I would now like to hand the conference over to Marissa Baish with Investor Relations.

Hi, thank you, and thank you all for joining today's call. Joining me are Erica Rogers, Chief Executive Officer, and Lucas Buchanan, Chief Financial Officer and Chief Operating Officer. Earlier today, Silk Road Medical released financial results for the three months ended June 30, 2022. A copy of the press release is available on the company'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 the 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, those relating to our operating trends and future financial performance, expense management, Expectations for hiring and growth in our organization, physician training and adoption, market opportunity and penetration, commercial and international expansion, regulatory approvals, reimbursement, competition, and product development are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties 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 a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2022. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, July 26, 2022. Silk Road Medical 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. Now I will turn the call over to Erica Rogers, Chief Executive Officer.

Thank you, Marissa. Good afternoon, and thank you all for joining us. We are pleased to share our recent performance with you today and highlight a series of significant achievements at Silk Road Medical in the second quarter of the year. First and foremost, we drove strong TCAR adoption marked by $33.2 million in revenues and 4,700 procedures for the quarter, reflecting 25% and 29% year-over-year growth, respectively. Before reviewing our results in greater detail, let me expand upon our successful efforts to widen the reach and impact of minimally invasive TCAR across all eligible patients. Early in the second quarter, we received FDA approval for the expanded indication of our en route trans-carotid stent system to include patients at standard risk for adverse events from carotid endarterectomy or standard surgical risk. This approval opens our currently addressable market opportunity to the entire U.S. carotid artery procedure market of approximately 170,000 annual procedures. More importantly, this expansion levels the playing field between TCAR and CEA as physicians now have the discretion to treat any eligible patient with a TCAR procedure. As captured in a recent press release by the Society for Vascular Surgery, the data supporting TCAR use in standard surgical risk patients offers compelling reason for clinicians to more widely adopt TCAR technology as it has demonstrated both safety and efficacy and presents an excellent alternative to CEA. Within weeks of FDA approval, we also received expanded Medicare coverage for TCAR and standard surgical risk patients under the national coverage determination within the TCAR surveillance project, ensuring that all CARADA patients who require treatment have the opportunity to benefit from a minimally invasive approach. We're grateful to the teams at FDA, CMS, and the Society for Vascular Surgery for their valuable contribution and partnership in recognizing the weight of real-world evidence supporting TCAR use in this expanded patient population and the significance of preventing the debilitating impacts of stroke on individuals, their families, and the health system as a whole. Lastly, we formally announced Roadster 3 in June, our post-approval study designed to assess the real-world treatment of standard surgical risk patients with TCAR. This prospective single-arm study will enroll a maximum of 400 patients across roughly 60 leading clinical research sites. And the primary endpoint is a composite of major adverse events, including death, stroke, or myocardial infarction through 30 days post-procedure, plus ipsilateral stroke from day 31 to 365 procedure. We are excited to add prospective data to the already compelling real-world clinical evidence for TCAR in standard surgical risk patients, and we look forward to updating you as the study progresses. We are now investing substantial time and resources in marketing efforts specific to standard surgical risk label expansion, with a focus on incorporating our patient-first mentality. including updated sales and marketing materials, direct print and digital communications, and patient stories and testimonials, all as part of our broader primary strategic priority of U.S. commercial execution. On that note, I am pleased to review our commercial progress in the second quarter in greater detail. As evidenced through our Q2 results, we are making steady progress toward penetrating the large and still untapped pool of carotid procedure volume. Exiting the second quarter, we are well on our way toward reaching our year-end goals of 70 to 75 active territories and 200 to 300 new physicians trained. Our efforts to drive more frequent and deeper customer engagement are yielding strong results, meaningfully increasing procedures per trained physician across our sales territories. Based on our strong first half UST CAR procedure growth and our outlook over the remainder of the year, we are pleased to raise our 2022 revenue guidance to $128 to $133 million reflecting year-over-year growth of 29% at the midpoint of the range. We continue to expect the vast majority of our 2022 revenue to come from TCAR procedures in the legacy high surgical risk patient population, with a gradual layering effect from standard surgical risk expansion into 2023 and beyond. That said, we view our opportunity holistically and do not intend to distinguish our expectations by patient subpopulation in the future. As we like to say, 100% of these patients are at risk for stroke from their disease process, and 100% are at risk of complication from invasive surgery, and we expect to continue to take share from CEA. Lucas will provide greater detail regarding our financial outlook shortly. In summary, TCAR is finding a prominent place in the carotid treatment continuum. In fact, we're excited to share that we recently celebrated our 50,000th TCAR procedure performed to date, an incredible testament to our impact on the lives of patients and their families. We know that stroke risk does not stop, and patients need to be protected from its devastating consequences regardless of the broader healthcare operating environment. We are executing well against the substantial opportunity ahead of us as we continue to progress initiatives to expand our business over the longer term, looking at both complementary and tangential opportunities. We're looking forward to providing updates on these longer-term initiatives over the next several quarters. With that, I will now turn the call over to Lucas Buchanan, our Chief Financial Officer and Chief Operating Officer.