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Silk Road Medical, Inc.
5/9/2023
Good day. Thank you for standing by. Welcome to the Silk Road Medical's 2023 First Quarter Earnings Call. At this time, participants are in a listen-only mode. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Marissa Beisch, Investor Relations. Please go ahead.
Great, and thank you for joining today's call. Joining me are Erica Rogers, Chief Executive Officer, and Lucas Buchanan, Chief Financial Officer and Chief Offering Officer. Earlier today, Silk Road Medical released financial results for the three months ended March 31, 2023. 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 federal securities laws that 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 and our business, 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 Foreign Temp Q filed with the Securities and Exchange Commission on May 9, 2023. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 9, 2023. 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. And with that, I will turn the call over to Erica Rogers, Chief Executive Officer.
Good afternoon, and thank you all for joining us. Our first quarter progress marks the start of an important year at Silk Road as we capitalize on the strong foundation we have built to drive TCAR adoption and alleviate the devastating burden of stroke on patients' lives. We delivered revenue of $40.1 million, reflecting 43% year-over-year growth, supported by over 5,800 procedures. We are pleased to see strong underlying demand for TCAR, and considering our progress thus far and our outlook ahead, we are reiterating our guidance for $176 to $184 million in total 2023 revenue. As we make our way through the year, our most important objective remains to grow our business through U.S. physician adoption as we march toward the standard of care. The largest opportunity to do so comes from leveraging our broad commercial footprint to drive utilization across our trained physician base. This includes onboarding and training new sales, sales management, and other field professionals to expand and align our territories as we increase touchpoints with our customers. Early in the year, with this objective in mind, we carried forward an initiative to further optimize our expanding sales organization through hiring, promotions, and territory design. We have been pleased with our recruiting ability and the quality of the candidates that seek out Silk Road Medical. And we believe this effort creates the right structural balance for strong, continued growth looking forward. Simultaneously, we are strengthening our category leadership and commercial prospects following the expansion of our addressable market last year to include patients at standard surgical risk of surgical complications. TCAR has demonstrated exceptional outcomes in this patient population. And we were pleased to see a paper published recently in JAMA Neurology built on real-world propensity-matched data in over 20,000 patients from the Vascular Quality Initiative, or VQI, which investigated outcomes in standard surgical risk patients treated with TCAR versus CEA. Outcomes from the publication largely reflect Liang et al.' 's presentation at the vascular annual meeting in 2021. The study found statistically equivalent outcomes across primary endpoints with significantly lower incidence of cranial nerve injury and procedure time using TCAR. The paper represents another important piece of clinical evidence and provides a strong foundation for our early momentum in this expanded patient population. We will continue to reinforce TCAR's value proposition in this expanded population, and all eligible patients for that matter, through the continued collection and analysis of real-world outcomes in the VQI. In 2022 alone, there were 31 TCAR-related VQI papers published in major medical journals, and another 11 in the first quarter of this year. Roadster III Our prospective post-approval study for patients at standard risk for surgical complications recently eclipsed the 100 patients enrolled mark, and we are excited about the progress to date. The undeniable benefits of TCAR versus transfemoral carotid stenting and carotid endarterectomy continue to accrue. As we lead the field of stroke prevention forward, we are expanding and diversifying our portfolio by innovating around our trans carotid and neuroprotection core competencies. After a successful limited market release, we recently initiated the full-scale commercial launch of Inflate, the first balloon purpose-built for TCAR and the fifth product in our market-leading portfolio. Early traction and utilization patterns are encouraging as we work through hospital contracting and continue to conduct the first cases across many TCAR centers. I'm also excited to announce that we received 510 clearance for our next generation en route neuroprotection system, or NPS Plus. This product was designed to further support the ease of use and minimize the risk of complications. We anticipate a limited market release followed by a broader release later this year. Finally, we continue to lay the groundwork to broaden our geographic reach, starting with China and Japan. I am pleased to share that we received clearance in Q1 in China for our enroute neuroprotection system. We are now focused on approval for our enroute stent, as well as regulatory activities supporting future clearance of the enroute NPS+. In Japan, we are actively investigating potential distribution partners while we work towards a reimbursement submission later this year, following the clearance of our enroute neuroprotection system and enroute stent last year. We are also working towards clearance of NPS+. While there are several steps ahead on our path to commercialization in these countries, we are well on our way to unlocking the $2.3 billion international market opportunity. In summary, we are pleased to deliver strong growth in our business while our investments to diversify through product and geographic expansion begin to deliver. I'll now turn the call over to Lucas Buchanan, Chief Financial Officer and Chief Operating Officer.
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