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spk09: Good day and thank you for standing by. Welcome to the Silk Road Medical's 2021 Third Quarter Earnings. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Marisa Bach, Investor Relations. Please go ahead.
spk07: 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 September 30, 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 provision 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 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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2021. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 9, 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 Rogers, Chief Executive Officer.
spk02: Thank you, Marissa. Good afternoon, and thank you all for joining us. I would like to start by acknowledging the immense efforts of the Silk Road team and our physician partners as we continue driving adoption of TCAR forward. against the headwinds of the COVID-19 pandemic. The third quarter was a difficult period for the U.S. hospital system and specifically for elective inpatient procedures like TCAR. As we signaled in mid-September, the COVID-19 Delta variant drove capacity constraints, staffing shortages, and overall disruption in a significant percentage of hospitals across our sales regions. Despite these challenges, we recognize $24.7 million in revenue for the quarter, reflecting 23% year-over-year growth. The pandemic and its consequences have created a more complex environment and a greater impact to our business than we had expected back in July, which carried over from Q3 into Q4. As a result of these dynamics, we are revising our 2021 revenue guidance to a range of $99 million to $102 million. Lucas will discuss our full results and provide more commentary on our financial outlook shortly. As we look at our business, we are confident that the headwinds we have been facing are overwhelmingly pandemic-related and, in our view, transient. In regions where vaccination rates are high and hospitals have capacity, patients are presenting and we are executing on our strategy. In fact, despite COVID hospitalizations soaring during the recent Delta wave, the total number of physicians performing a TCAR in Q3 was in line with Q2. Even in the hardest hit areas of the country, trained physicians continued to perform TCAR albeit fewer procedures. Our regional utilization data also allows us to analyze the relationship between TCAR procedures and COVID hospitalizations across specific parts of the country. This analysis shows a stark contrast between the rate of procedures in less impacted versus harder hit regions during the third quarter. For example, in Southern, and Midwestern regions, both heavily impacted by the Delta variant, procedures per physician fell roughly 13% in Q3 versus Q2. In the Northeast, Mid-Atlantic, and Western regions, areas with higher vaccination rates and fewer hospitalizations, procedures per physician grew roughly 10%. In totality, this analysis offers an encouraging view of the performance of our business and the prospects for future growth as the pandemic wanes. On our last call, we said that our business was back on offense, and today we remain just as excited about our underlying opportunity for growth and penetration over the coming year as we did three months ago. We are hopeful for a future in which COVID-19 is endemic and managed without the severe spikes in hospitalizations that we have seen over the last 18 months. As of now, and as we have throughout the pandemic, we are investing confidently in the people and programs that will drive our growth in 2022 and beyond. We remain as committed as ever to establishing TCAR as the new standard of care in carotid artery disease. With that, our number one strategic priority for 2021 is US commercial execution. Today, we are pleased to announce that we are on track to exceed our goal of training at least 200 new physicians by the end of the year. We are also on track to exceed our territory expansion target of at least 50 sales territories by the end of the year. Importantly, As measured by time from training, procedures per physician continues to grow overall and across each utilization quartile, despite continued growth in the denominator of trained physicians. This remains true even against the pandemic's dampening effects on carotid diagnoses and procedures and the overall healthcare system. We are actively building relationships across physicians and hospitals to bring to fruition the long-term value of TCAR, a value unshaken by COVID, and we are reducing the risk of stroke and its devastating impact for patients every single day. We remain well-positioned to increase our procedural share versus CEA, given expansion of our field team, initiatives to drive physicians up the adoption curve, physician training programs, and the continually growing base of clinical evidence for TCAR. Moving on to our second strategic priority for the year, preparing for standard surgical risk expansion. At the 2021 Vascular Annual Meeting in August, an independent propensity-matched analysis in over 20,000 standard surgical risk patients illustrated equivalent risk of perioperative stroke, death, or MI plus ipsilateral stroke through one year in CEA versus TCAR, with cranial nerve injury risk significantly reduced with TCAR. Conclusions of the study were clearly outlined. TCAR should be expanded for use in standard surgical risk patients. The study affirms what we already understand at Silk Road. Safely preventing stroke while delivering benefits from a less invasive approach is possible across a broad range of patients, anatomies, and disease morphologies. TCAR's clinical and patient satisfaction benefits paired with its proven efficiencies over CEA give us confidence in driving adoption and advancing our impact on the lives of patients at risk for stroke due to carotid artery disease over the long term. Importantly, we are making progress toward receiving FDA approval to expand indications for TCAR into the standard surgical risk patient population. In October, the FDA requested that we provide them with additional data. We have since submitted that additional information as an amendment, and we believe that we are still on track to receive an FDA decision by the second quarter of 2022. Our teams and the physician community remain enthusiastic about the opportunity for standard surgical risk label expansion, bringing TCAR to a level playing field with CEA, and we continue to prepare for commercial launch. This includes planning for a post-market study, engaging with CMS on reimbursement coverage, supply chain preparation, and augmenting our training and marketing programs and materials. Regarding our additional long-term growth drivers, we continue to make progress on objectives to introduce new and improved TCAR products, expand into international markets, and innovate new trans-carotid therapies in neurovascular and carotid disease states, cardiac disease states, excuse me. For example, we are active in site initiation processes for our Neuroprotection in Transcarotid Embolectomy, or NITE1, feasibility study. Our R&D headcount, programs, and capabilities continue to grow. We remain committed to extending and deepening our significant lead in developing the TCAR market in the U.S. with numerous product and clinical initiatives. while working to unlock the $5.1 billion TAM associated with exporting TCAR globally. We expect to provide further updates on many of these initiatives on our future earnings calls. In closing, we were surprised by the speed and the severity with which the Delta variant impacted the U.S. hospital system in Q3. And we acknowledge that our second half revenue results will reflect the challenges in our operating environment. However, we are encouraged by the fundamentals of our business as the environment begins to clear. As we sit here today, we are seeing early signs of improvement, which we continue to closely monitor. We also intend to remain transparent regarding the ongoing pandemic and its impact to our expectations. We are incredibly proud of Silk Road's response to the challenges posed by COVID, and our excitement for the opportunity to re-accelerate into 2022 remains unhindered. Most importantly, our dedication to the long-term value of TCAR for patients and hospitals alike remains stronger than ever. With that, I will now turn the call over to Lucas Buchanan, our Chief Financial Officer and Chief Operating Officer.
spk05: Thank you, Erica. Revenue for the three months ended September 30, 2021 was $24.7 million, a 23% increase from $20.1 million in the same period of the prior year. The number of TCAR procedures in the quarter was just shy of 3,400, a 20% increase from the same period of the prior year. Year-over-year growth was driven by increased adoption of TCAR across an expanded base of hospital accounts, trained physicians, and active sales territories despite the more constrained environment due to the Delta variant impact in the third quarter of 2021 as compared to the same period of 2020. Gross margin for the third quarter of 2021 was 75% compared to 73% in the third quarter of the prior year. Gross margin in the prior year period included unfavorable production variances as a result of temporarily idle manufacturing operations and lower than anticipated demand due to COVID-19. Total operating expenses for the third quarter of 2021 were $31.9 million, a 33% increase from $23.9 million in the third quarter of 2020. R&D expenses for the third quarter of 2021 were $6.9 million compared to $4.7 million in the third quarter of 2020. The increase in R&D expenses was driven by growth in personnel and investment in new and ongoing R&D programs. Sales general and administrative expenses for the third quarter of 2021 were $25 million, compared to $19.2 million in the third quarter of 2020. The increase was due to the continued expansion of our sales team and commercial efforts, and general corporate and other costs associated with operating as a public company. Net loss for the third quarter was $13.9 million, equating to a loss of 40 cents per share, as compared to a net loss of 10.3 million or a loss of 31 cents per share for the same period of the prior year. We ended the quarter with $122.8 million of cash, cash equivalents and short-term investments. As Erica mentioned, our updated revenue expectations for 2021 are in the range of 99 to $102 million. Although US COVID hospitalizations have been steadily declining since early September, the Delta wave is receding more slowly than the late 2020 to early 21 winter wave. Today, we are encouraged that COVID-19 hospitalizations and the rate of community spread is quite low in some of the regions of the country that were the hardest hit in Q3. But there are still almost 47,000 patients hospitalized with COVID across the country, with hospitalizations still rising in 12 states and cases still rising in 23 states. Delta continues to move. Staffing issues remain as frontline workers seek higher-paying jobs and feelings of burnout persist. These phenomena, in turn, drive competition among physicians and therapies for scarce OR time and staffed inpatient beds. All of these factors inform our revised guidance, and it goes without saying there is continued uncertainty around the future course of the pandemic inpatient behavior. All said, we are holding our own and continuing to expand our presence in this environment. As a reminder, our 2021 revenue guidance does not assume any contribution from a standard surgical risk label expansion. At this point, I'd like to turn the call back to Erica for closing comments.
spk02: Thank you, Lucas. We are very pleased with our strong year-to-date performance despite the headwinds associated with the Delta variant, and we are confident that Silk Road remains well-positioned for strong growth into 2022 and beyond. Our teams remain dedicated to meaningfully impacting both stroke prevention and acute stroke treatment, and we know that our impact will continue to grow as the pandemic's disruption subsides. And speaking of our teams, I want to highlight our recent in-person national sales meeting, which we held in September after multiple delays. This year's meeting carried more meaning than prior years, with our people bringing an unparalleled enthusiasm to our three-day event following a very long period of pandemic-driven separation. It was not only an opportunity to organize and emphasize our goals around physician adoption, it was also an opportunity to unify a team fighting for a better standard of care. The energy and sense of purpose was palpable across the organization and emphasized that human capital is Silk Road's strongest asset. In addition, just two weeks ago, our teams honored World Stroke Day, taking pride in the efforts of Silk Road in improving awareness and, more importantly, preventing stroke and its horrible ramifications for patients and their families. We are confident in the continued growth and development of our commercial team as we recognize the enormous market potential for TCAR and the associated career opportunities for those who seek to make a difference. As we move toward the end of 2021, we are encouraged by early signs of recovery from Delta variant, and more importantly, Silk Road's long-term value proposition. We continue in our persistence to improve patient outcomes and remain committed to new therapies across new indications in the years ahead. With that, we will now open it up to questions. Joining me and Lucas Buchanan today for the question and answer portion of the call is our Chief Commercial Officer, Andy Davis. Operator?
spk09: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Our first question comes from the line of Roby Marcus from J.P. Morgan.
spk06: Hi. This is actually Lily on for Robbie. Thanks for taking the question. I know it's still early, but I was hoping you could share some early thoughts on 2022. Do you think where the street is sitting right now at $145 million is a reasonable place to be right now for next year? Any color you could share there would be helpful. Thanks.
spk05: Hi, Lily. I'll take that one. We're not providing 2022 guidance today. I think the The takeaway is we continue, as we have throughout the pandemic, to invest in the key inputs of our business, namely opening new hospital accounts, training physicians, and expanding our sales team. And that all drives future growth. And so we provided some color on our progress on those fronts that we think set us up well for the future.
spk06: Got it. That's fair. And just a quick follow up on standard risk. Is there any way you can quantify to what extent you've been treating standard risk patients right now before formally getting it on label? Is 15 to 25% of procedures a fair assumption? Thanks.
spk02: Hi, Lily. I'll take that one. We have not provided any quantification. I think this question is probably born out of the fact that there were a fair number of patients presented in some data at the vascular annual meeting back in August. And I think the way to explain that is that the definition the authors used for standard surgical risk was slightly different than other definitions of standard risk, and namely in the age cutoff, which provided a big area of overlap in patients. And so the best way to think about it, Lily, is that there's no sort of black and white in the eyes of a physician on standard surgical risk versus high risk. There are degrees of risk in the interpretation of physicians. Clearly, the company sticks to our approved and labeled indication, which is high surgical risk.
spk06: Got it. That's helpful. Thanks again.
spk09: Our next question comes from the line of Rick Weiss from Stifel.
spk01: Good afternoon to you both. Erica, back to, you know, hard not to start with COVID again. You said very specifically you're seeing early signs of improvement. I wanted to make sure I really understood exactly what you're saying. You're saying in Since the start of the fourth quarter, last week, over the last few weeks, you know, and you give us a beautiful breakdown by region and tiers and everything, but is it regional? Is it across the board? How do we think about that statement and reflecting on the new guidance for the fourth quarter especially?
spk02: Yeah, let me take part of that for you, Rick, and thanks for joining us today. So, I mean, really simply put, TCAR is right in the crosshairs of the Delta variant, and, you know, we saw real impacts in certain regions that are less vaccinated that led to, obviously, higher hospitalizations. I do want to remind everyone that we are a U.S.-only business that is inpatient. and majority elective when you think about the mix of asymptomatic versus symptomatic. And so we were right in those crosshairs of the hardest hit areas of the Delta variant, which turned out to be the South and the Midwest, as we said in our prepared remarks. As it relates to the quarter, I think it's safe to say that the recovery from Delta variant has been slower than what we saw in the winter wave. You know, the sort of bounce back that we saw coming out of the first quarter, it has not been like that with the Delta variant. And as we said in our prepared remarks, it even spilled over into October, into this quarter. Now, sitting here today in November, you know, we like what we're seeing in the past really few, you know, few parts of the early part of November. but I think it's safe to say that Delta extended into October.
spk01: Yeah, no, it makes sense. I didn't know whether, Lucas, you wanted to say something or should I go ahead?
spk05: Yeah, I can add a little color. I mean, again, kind of as COVID hospitalizations go, so does TCAR procedures for better or for worse, depending on whether the hospitalizations are going up or going down. And so, With that, the monthly procedure volume has improved from September over August and October over September. And as Erica mentioned, November is trending well. So it kind of matches that curve, so to say. Gotcha.
spk01: Turning back to the topic of label expansion, I mean, it's encouraging, obviously, that FDA asked you were able to submit That sounds great. But unless I'm misremembering, Erica, I think your prior public statements were you were hoping for late 21, early 22. And if I heard you correctly tonight, you're saying 2Q21. Is that understandable conservatism, given everything that's happening in the world? Is it that the request for data still slowed things down? Or how do we think about that, if my memory is correct here?
spk02: Yeah, no, I mean, it's simple. We are still within the timing expectation that we set forth. You know, sitting here on November 9th, obviously, we're running out of days in the quarter, but the realm of options is still what we stated in the beginning.
spk01: Okay, so no change there. Great. Okay, and maybe last for me, maybe this is more for Lucas or whoever. the unusually high SG&A spend this quarter. You know, I think it's the highest dollar number I've seen, 25 million, you know, up sequentially a few million. And you sort of said it right up front, at least in the press release, you're investing in multiple ways, expansion of teams, commercial efforts, et cetera. Maybe help us understand, were that unusual spend? Is this getting ready for standard risk? Is this international preparedness? Is this, you know, opening new hospitals? Help us understand. And where do we go from here with that kind of dollars?
spk05: I think that's quite simple as well, Rick. And it really comes down to primarily the U.S. commercial effort and investing in the expansion of in territories, which we've said all along that our goal for this year was to be in excess of 50 territories. And Erica mentioned we expect to exceed that on our way to roughly 75 by the end of next year, which is really the coverage model that we think really covers the bulk of the market in terms of the hospitals and docs that we want to train and market to and drive their adoption curve. So some of it is timing. with respect to, you know, it's not a linear growth pattern in terms of the commercial headcount. And Q4 was a little heavier than prior quarters. And I think, again, the key takeaway here is we continue to invest confidently because the fundamentals of the business are strong when you strip out the COVID impacts.
spk01: Yeah. Thank you. And truly, congratulations on a very solid quarter, and I know it's a challenging time, so it's great to see it. Thank you.
spk02: Thank you, Rick.
spk09: Our next question comes from the line of Adam Mater from Piper Sandler.
spk04: Hey, guys. Appreciate you taking the questions here, and congrats on the progress. Wanted to start on standard surgical risk and maybe just ask for any kind of new updates or line of thinking around reimbursement and then post-market approval study. I mean, I think you touched on both of those briefly in the prepared remarks, but wondering if the expectation is that reimbursement will come in tandem with FDA approval or subsequent to, and then was wondering if you could kind of flesh out how you think about the post-market study that will likely coincide with standard surgical risk. And then I had a follow-up. Thanks.
spk02: Sure. Hi, Adam. Thanks for joining us. So in terms of CMS coverage, you know, as we've said all along, we've kind of been in lockstep conversation with CMS and FDA and the Society of Vascular Surgery really every step of the way since the dawn of time, but even more specifically here on standard surgical risk. And so typically the coverage specifics won't be worked out until the actual approval is in hand, but the conversations have begun. So they will happen one after the other, but we expect it to be an efficient process with CMS. As it relates to a post-market study, we are kind of following what has happened historically with carotid artery stent approvals or label expansions, which is they typically are accompanied with a post-market study requirement. And so we are planning as such. which means that we're doing the work of figuring out what a protocol might look like, what the sites might look like, who the PIs might be, all of those kinds of things, just getting in the ready position.
spk04: Got it. That's helpful, Erica. Thanks for that. And then for the follow-up, just switching over to the international go-to-market initiatives that you're in progress with, Just anything more that you can share on China and Japan, the progress that you're making in those geographies and potential timelines. And curious if there's updates on things like reimbursement or infrastructure. And I guess the big question I'm really just trying to better understand is if we should think about 2023 as a reasonable base case for international revenue contribution if it's 2024. So if you could help orient us there, that would be great. Thanks so much.
spk02: Yeah. So we continue to make progress in the quarter on both China and Japan. Right now, it's really all about the regulatory effort, which does dovetail with the coverage and reimbursement efforts in those countries as well. So they're not, you know, really ultra-distinct processes. All of it wheels in motion right now, and we did make good progress in the quarter. I think we also talked about on our last call that we've been engaging with potential commercial partners, which is to say that we're likely to partner with somebody already in those geographies versus kind of propping up our own direct organization in either of those two countries. And those conversations have also moved forward in the quarter. As it relates to timing of commercialization, you know, Adam, we just haven't given any specifics there yet. I know that's not a super satisfactory answer, but when we have more meat on the bones on precise regulatory, you know, outcomes, I think at that point we can begin to talk about timing.
spk04: Okay. Understood. Understood. You're taking the questions.
spk02: Yeah. Yeah.
spk09: Our next question comes from the line of Daniel Antolfi from SVP Lyric.
spk03: Hey, good afternoon, guys. Thanks so much for taking the question. Just one follow-up question on the data filing for standard risk, Erica. If you could give any color on sort of what the new data update might have been that you filed or how to think about it. Is this an entirely new data set? Is it just incremental data or another cut of the data that you already filed? And then I have one follow-up just on the quarterly results.
spk02: Sure, Danielle. Hi. Thanks so much for joining us. So, you know, typical of PMAs, there's been a lot of back and forth with the FDA kind of all along, even prior to the submission itself and since the submission. And so we got a question from FDA, and upon clarifying what that question meant, we basically did a kind of subset analysis of existing data is the way to think about it.
spk03: Okay. Got it. That's helpful. And then as it relates to the quarter, I don't know if you guys even track it this way, excuse me, even track it this way, but the COVID, is there a way to quantify, you gave some numbers that were very helpful about like growth in regions that weren't significantly impacted by COVID, but can you quantify like a dollar value from COVID? And if not, maybe even some color on sort of where we are in the referral funnel, if you have visibility into that and sort of cancel, you know, how many procedures that are not, you know, asymptomatic have been canceled, anything to give some color on sort of what the impact was would be super helpful. Thank you, guys.
spk05: Yeah, let me take the first half of that, and I'll pass it over to Andy for the second half. You know, one thing Erica mentioned is that, you know, a disproportionate share of our procedures and therefore revenue, you know, comes from states and regions where cardiovascular disease is prevalent. you know, risk factors are high and disease burden is high, which also correlates with areas of the country that are less vaccinated and have higher hospitalization rates. So that's part of it. And again, you know, we did an analysis year to date looking at regression analysis, looking at COVID hospitalizations as the input nationally and TCAR procedures as the output, and it's incredibly statistically significant and explains most of the variation in procedures. And so, again, that gives us confidence coupled with the data from less hit regions and the fundamentals there that this is at least transient with the current aspects of the pandemic. We'll see what the future holds. Obviously, we're all hopeful for an endemic management and new antivirals and more vaccination and kids getting vaccinated and all those things into 2022, but we're also less and less in the business of predicting where COVID goes. I'll turn it over to Andy for the other half of the question.
spk00: Sure. I'll address the funnel impact on the patient pipeline and We remain very optimistic that patient behavior is continuing to improve as the COVID Delta variant lifts. They're going back to the doctors. They're being diagnosed. They're being put into the queue to be treated. So we have seen a dramatic increase in that behavior, which is good, and that's in the recent weeks. More importantly, as the Delta variant really hit us throughout the August, September, October timeframe, we do, to our best ability, track patients that were in the queue where procedures were being canceled and or delayed. So we're working very closely with our physicians to find those patients and get them back into the queue to be treated. So we monitor and measure that very closely. So we feel like we're going to be able to capture a fair amount of those patients that were on the sidelines as the hospitalizations and capacity really impacted our ability to treat them. So we feel optimistic. The fundamentals are still intact, and I'm bullish on the days ahead.
spk03: Thanks for the color.
spk02: Thanks, Danielle.
spk09: Our next question comes from from CD.
spk08: Good afternoon, and can you hear me okay?
spk02: Yes, we can. Hi, Joanne. Thanks for joining us.
spk08: Hi. Thank you for taking the question. I'm curious on your last question. Have you started to think about how the backlog is building so that when the physicians and the patients sort of feel more comfortable getting back into the operating room, they can do so?
spk02: Yeah, I think there's a two-part answer to that, Joanne. I mean, as Andy just said, the business of health care is starting to return again, right? This is the second go-round of recovery this year, as you know. But it is starting to return. Patients are back in the funnel in these hard-hit regions that we've been describing. So that's a very positive trend here. I think the other thing that we have to talk about out loud is this staffing shortage issue, which we mentioned in our prepared remarks. It is very real. You know, Andy and his team are experiencing this every day to the extent that we're doing procedures on the weekends because they can't get them scheduled during the week. And so what that has created is this competitive environment for OR space and people and staffed beds. regular hospital beds and ICU beds alike. And so all of these elective-type procedures, even the urgent elective, which is the category that we're in, are fighting for resources, quite frankly, in some of these very hard-hit areas. And, in fact, there's an anecdote that we just heard the other day that the National Guard is being called in to the Pacific Northwest to help staff hospitals So it is still quite challenging from a staffing perspective. I'll add to that.
spk00: I'm sorry, go ahead.
spk08: No, no, go ahead.
spk00: I was just going to add that it's a really interesting conundrum because we had many, many days and months where there weren't enough beds to treat patients. Now there are enough beds but not enough people to support the patient flow. So one problem is... fixed and another problem rears its ugly head. But we're working through it.
spk08: Thank you. I was just looking for if there was a way to quantify the backlog that's building. And there may not be, but I was just curious about that.
spk05: Well, in prior periods, Joanne, the backlog cleared quite quickly. But in prior periods, we weren't dealing with as much of a staffing issue.
spk00: Right, right.
spk05: So it's a little bit harder to say as we sit here today. Obviously, you know, the wave itself is receding slightly more slowly, and there's different variables at play. But again, in prior times, the backlog cleared quite quickly because these patients are at risk for stroke. And once the decision's been made to treat, it's not made lightly, as we've always talked about. So they do want to get these patients treated as soon as they can. There is some yield loss to patients that don't come back for whatever reason, but as Andy said, the team is working hard to help make sure that we're doing everything we can to bring patients back.
spk08: Kathryn Baxter That clarification is helpful. Thank you. And then my second question really has to do with the timing of some of the other efforts that you've unveiled. you know, outside of TCAR? Should we be looking for announcements of that, like, in the coming quarters or at least maybe in 2022?
spk02: Yeah, I think some of the things that we talked about in the prepared remarks, for example, the NITE-1 study, the Neuroprotection in Transcarotid Embolectomy Study, we're making good progress on site initiations and getting those sites ready to enroll. So we're hopeful that there will be some further discussion about that trial in future earnings calls coming up.
spk08: Terrific. Thank you so much for taking the questions.
spk02: Thanks, Joanne.
spk09: That concludes the Q&A session. I will now turn the call over to Erica Rogers for closing remarks.
spk02: Thank you all for your time and attention today.
spk09: Today's conference call is now concluded. Thank you. You may now disconnect your line.
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