Silk Road Medical, Inc.

to Silk Road Medical Conference Call. At this time, all participants are in a listener-only mode. After the speaker's 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, and you will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Marisha Beisch. Please go ahead.

Thank you 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 and 12 months under December 31, 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 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 Form 10-Q filed with the Securities and Exchange Commission on November 9, 2022. This conference call contains time-sensitive information and is accurate only as it's a live broadcast today, February 28, 2023. Silk Road Medical just claims 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. 2022 closes the books on a remarkable year at Silk Road. We achieved total revenue of $138.6 million, supported by over 19,500 procedures, representing 37% and 41% year-over-year growth, respectively. Our performance was driven by growing physician adoption and acceptance of TCAR as the solution in minimally invasive stroke prevention. We achieved our full year territory expansion expectations and exceeded our trained physician guidance in response to increased demand. We also made important progress toward our objective of strengthening Silk Road's category leadership in the treatment of carotid artery disease. with the expansion of TCAR's labeled indication to include patients at standard risk for surgical complications. The FDA approval in May, promptly followed by expanded Medicare coverage within the TCAR surveillance project, opened our addressable market to the entire 170,000 annual carotid procedures in the United States. While expanding our access to the full 430,000 annual U.S. diagnoses, representing a $3.2 billion opportunity. Physicians are now able to simplify treatment decisions with the best interest and preference of patients at the core. Our success remains rooted in the large and expanding body of clinical evidence in support of TCAR. In 2002, we surpassed 25,000 patients' worth of clinical data from trials and registries published in high-impact factor peer-reviewed medical journals. In fact, we saw over 85 TCAR publications within the year, authored by over 75 distinguished physicians with broad reach across the United States. And we are pleased that the Society for Vascular Surgery Vascular Quality Initiative, the SVSVQI dataset, continues to grow rapidly. This allows TCAR-performing physicians to assess real-world data in a contemporary timeframe sourced independent of industry. Adding to our 2022 successes, we bolstered our balance sheet by nearly $135 million, paving the way for ongoing investment and growth as we drive toward profitability. We also brought our Minnesota facility online, adding manufacturing and distribution capacity as well as access to a talented workforce. We will continue to prioritize advancements in US TCAR, specifically in our commercial team, product R&D, and ongoing clinical data such as Roadster 3. Our focus is on strategies to enhance our trajectory and meaningfully scale our business over time. This brings me to our 2023 objectives. Number one, grow. As we shift our focus to the year ahead, our first objective remains consistent, driving increased TCAR utilization through strong commercial execution. We know that the largest opportunity in front of us is bringing physicians up the adoption curve in the form of higher TCAR usage. And we know from years of commercial expansion that we achieve strong returns on increased physician engagement. That's why, throughout this year, we remain focused on driving more touchpoints with physicians through territory expansion and comprehensive marketing campaigns. Now, more than ever, we are focused on highlighting the patient benefits of TCAR over other alternatives. We will continue to generate evidence to support patient decision-making and extend our commercial reach to more patient-centered stakeholders. as we drive TCAR market penetration from roughly 12% in 2022 to mid-teens over the coming year and strong double digits beyond. We are immensely excited about the trajectory ahead and remain focused on progressing TCAR toward the standard of care. Our second priority is to strengthen the business. We've spent the last five plus years laying a foundation for growth in the U.S. carotid disease market. through our broad portfolio of key car products, solid commercial footprint, and robust operations. We are building upon the strength of this foundation to support our growth outlook and further extend our category leadership while we drive operating leverage on the path to creating and sustaining a profitable business. And finally, diversify, where our intentions are twofold. For one, this includes extending our geographic reach. Our goal has always been to make TCAR the standard of care for the treatment of carotid artery disease globally. We made meaningful progress in 2022 on this front, receiving Shonin approvals in Japan for both our on-route neuroprotection system and the on-route stent. In addition to preparing for global launches, we will continue to expand on our core competencies through product innovation. This effort begins within carotid artery disease and positions us to expand the application of our category-leading technology beyond. As part of our ongoing pursuit of innovation in trans-carotid technologies, We recently announced the clearance of our Inflate Transcarotid Rapid Exchange Balloon Dilation Catheter, or Inflate for short. The first balloon, purpose-built for TCAR, and the fifth product in our TCAR portfolio. We initiated a limited launch of Inflate in the fourth quarter of 2022, and we plan to commence our full-scale commercial launch in the second quarter of this year. We have also made enrollment progress in our night one feasibility study in acute ischemic stroke, and we continue enrolling and learning in 2023. All said, we are enormously optimistic about the future of Silk Road Medical. We are pleased to initiate guidance of $176 to $184 million in full year 2023 revenue reflecting roughly 25,000 TCAR procedures at the midpoint of the range. We are confident in the year ahead and in our prospects for continued long-term growth. I will now turn the call over to Lucas Buchanan, our Chief Financial Officer and Chief Operating Officer.