Silk Road Medical, Inc.

Good day and thank you for standing by. Welcome to the Silk Road Medicals 2021 First Quarter Earnings Conference Call. At this time, all participants are in a listen-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 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your first speaker today, Ms. Caroline Paul from Investor Relations. Please go ahead.

Thank you. And thank you all for participating in 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-month-ended March 31, 2021. 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, 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, the impact of COVID-19 on our business and prospects for recovery, expense management, expectations for hiring, physician training and adoption, growth in our organization and reimbursement, market opportunity, commercial and international expansion, label expansion, and our product pipeline 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 yearly report on Form 10-K filed with the Securities and Exchange Commission on March 1st, 2021. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 4th, 2021. 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.

Thanks, Caroline. Good afternoon, and thank you for joining our first quarter 2021 earnings call. Joining me is Lucas Buchanan, our Chief Financial Officer and Chief Operating Officer. With the beginning of the end of the pandemic in sight, we are on the precipice of an exciting time, not only for Silk Road, but for the healthcare delivery system as a whole. As of April 28th, confirmed COVID-19 hospitalizations have fallen by 70% since early 2021. Furthermore, nearly 70% of the Medicare age population in the U.S. is fully vaccinated and getting back to routine healthcare activities. Physicians are back to the important work of caring for patients with carotid artery disease and we are intensely focused on moving our trained physicians up the adoption curve to capitalize on the recovery we are beginning to see across the U.S. We have ushered in the trans-carotid era and yet we are just beginning to scratch the surface of our total addressable market opportunity. Our long-term goal is to leverage our proprietary technology and expertise in new markets and expand the pool of patients that we can address. To this end, we are pleased with our meaningful advancements, not only towards driving the adoption curve in the U.S., but also towards new indications, new therapies under development, and expansion outside the U.S. Our first quarter performance was characterized by substantial progress across our commercial and operational initiatives. Physicians performed almost 3,000 TCAR procedures in the quarter, and we achieved total revenue of $22.1 million, reflecting growth of 16% year over year. Based on the strength of our first quarter results, momentum exiting the quarter, and expectations for continued recovery throughout the year, we expect top-line revenue for 2021 to be in the range of $103 million to $108 million, representing year-over-year growth of 40% at the midpoint. As anticipated, significant COVID-19 hospitalizations in November and December persisted into the first two months of this year. followed by a strong recovery in March, which has continued into the second quarter. We are optimistic that the pace of recovery will continue to accelerate and patients will become increasingly comfortable re-accessing both routine and inpatient care. Turning to our two strategic priorities for 2021, which we outlined during our fourth quarter earnings call, we continue to make meaningful strides on both, number one, U.S. commercial execution and driving the adoption curve, and number two, preparation for a potential standard surgical risk label expansion for the on-route stent. Starting with the adoption curve, as we've said in the past, the majority of our procedures are driven by trained physicians with at least one year of TCAR experience. That being said, it's no secret the past year has been a challenge for providers, patients, and industry personnel alike trying to deliver healthcare as usual in a constrained pandemic environment. Now that we are seeing some but not all of these constraints lifted, we're intensely focused on our already trained physician base of over 1,800 physicians exiting 2020. Many of those physicians were trained in the latter part of 2019 and early 2020, just before the pandemic began. As we've stated in the past, the first year following training is crucial for physicians to create a foundation from which to confidently increase their adoption of TCAR. To better serve these physicians, We have refocused our commercial and professional education organizations to provide additional hands-on in-person training and workshops to further adoption of TCAR and reinforce its benefits. As well, we continue to develop targeted marketing and sales tools segmented by physician TCAR experience and behavioral attributes and are measuring the impact of such efforts. We are pleased with progress made during the pandemic and excited about our momentum as it subsides. Thus, as always, we are focused on the large, untapped market opportunity in front of us to drive TCAR penetration in high surgical risk patients. Moving on to our second key priority, preparation for a potential standard surgical risk label expansion for the en route stent. As a reminder, the en route stent's current indication is for patients who are considered at high risk for having an adverse event from carotid endarterectomy, or high surgical risk. Standard surgical risk simply denotes an absence of one or more high surgical risk criteria. While there is ample market opportunity within high surgical risk patients, gaining access to the standard surgical risk patient population would increase our TAM by approximately 50%, while also positioning us on a level playing field with CEA for clinical decision making. During our fourth quarter earnings call, we indicated that we have made substantial progress with respect to our regulatory strategy by submitting a PMA supplement for the expanded indication. Furthermore, We are busy developing our launch strategy, defining reimbursement pathways, and anticipating post-approval study requirements. In addition to investments in our top two priorities, we continue to invest in long-term growth initiatives aimed at strengthening our ability to deepen and broaden our presence, as well as open up new market opportunities. These include investments in new and improved TCAR products, new trans-carotid therapies, and international expansion. And we have made meaningful advancements in all three. With respect to our product pipeline, I am very pleased to announce that the FDA recently approved an IDE for our night one feasibility study in acute ischemic stroke. In night one, we will be assessing the role of transcarotid access and flow reversal, our two core competencies, in a new procedure we call neuroprotection in transcarotid embolectomy, or NITE, N-I-T-E. We believe this is the first study of its kind to be conducted under a US IDE and represents an important step toward realizing a future of trans-carotid therapies for neurovascular diseases. Our vision is big and bold, and we believe NITE and other trans-carotid procedures will solve difficult clinical problems in the treatment of complex neurovascular disorders and become an important part of the treatment paradigm in the future. Leapfrog innovations typically require an accumulation of clinical evidence, and NITE-1 is likely the first of multiple future studies toward that end. While there are many milestones on the journey toward commercialization, this study should advance our understanding of the clinical benefits NITE can provide in the context of acute ischemic stroke. The era of trans-carotid therapies in neurovascular diseases has begun, and Silk Road is leading the way. We look forward to sharing more details as 2021 progresses and in the years ahead. To summarize, we are very pleased with the progress that we are making on all fronts as we continue to invest in our long-term growth. We are excited to announce that we are expanding our operations to include a facility in Minneapolis, which is an important talent pool for aspiring and experienced med tech professionals and a great compliment to our continued and growing presence in Silicon Valley. With that, I will now turn the call over to Lucas Buchanan, our Chief Financial Officer and Chief Operating Officer.