This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk00: Good day, ladies and gentlemen, and welcome to Inari Medical, Inc., third quarter 2021 earnings conference call. At this time, all participant lines are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will be given at that time. To ask a question, you will need to press star, then one on your telephone. As a reminder, this call is being recorded. If anyone should require operator assistance, please press star, then zero. I would now like to hand the conference over to your host today, Caroline Corner of Westwick. Please go ahead.
spk04: Thank you, Operator. Welcome to ANARI's third quarter 2021 earnings call. Joining me on today's call are Bill Hoffman, President and Chief Executive Officer, and Mitch Hill, Chief Financial Officer. This call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the markets in which Inari operates, trends and expectations for Inari's products and technology, trends and demands for Inari's products, Inari's expected financial performance, expenses, and position in the market, and the impact of COVID-19 on Inari's operations and Inari's customers' operations. These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from any results, performance, or achievements expressed or implied by the forward-looking statements. Please review ANARI's most recent filings with the SEC, particularly the risk factors described in ANARI's annual report on Form 10-K and in ANARI's quarterly report on Form 10-Q for the third quarter ended September 30, 2021, for additional information. Any forward-looking statements provided during this call, including projections for future performance, are based on management's expectations as of today. Inari undertakes no obligation to update these statements except as required by applicable law. Inari's press release with the third quarter 2021 results is available on Inari's website, www.inarimedical.com, under the Investors section, and includes additional details about Inari's financial results. Inari's website also has the latest SEC filings, which you are encouraged to review. A recording of today's call will be available on the NRE's website by 5 p.m. Pacific time today. Now I'd like to turn the call over to Bill for his comments on third quarter 2021 business highlights.
spk08: Thank you, Caroline, and thank you, everyone, for joining us today. Our third quarter was productive and successful, and we again treated a record number of patients. Our execution remains crisp in all parts of our business, and we continue to make significant progress on all five of our growth drivers. We are excited to share additional detail about our performance, but we would like to begin as usual with a patient story that might remind you of the wonderful impact our products and our people have on the lives of our patients. A couple of months ago, at the peak of the most recent COVID surge in Houston, Texas, one of the hardest hit regions in the U.S., a young woman presented to the emergency department of a hospital near her home with shortness of breath and chest pain. She was three weeks postpartum and so fatigued that she was struggling to take care of her newborn. Imaging tests revealed large blood clots in both her left and right lungs. The hospital was full of COVID patients and had no ICU beds available. Thrombolytic therapy, which necessitates an ICU stay, was the only treatment available, so this patient could not be treated. She was sent home that evening on oral anticoagulants, which reduce the risk of developing new clots, but do not eliminate existing clots. The following day, with worsening symptoms and now unable to climb the stairs to attend for her crying baby, she called an ambulance, which took her to a different hospital. This hospital was equally overwhelmed with COVID patients and also had no ICU beds. This hospital had been using Inari devices for more than a year. Inari procedures do not require an ICU stay. Within just one hour of her arrival at the hospital, the physician had already removed the entire clot burden from both lungs using flow treatments. Her symptoms resolved, her vital signs returned to normal, and she was moved to a regular hospital bed. And in less than two days, she was home with her new baby. The profound effect on the life of this young mom is perhaps as obvious as it is beautiful, as is the change in the trajectory of the life of her baby. Although we learn of these patient outcomes and stories like this on an almost daily basis now, we remain mindful of their impact. We are thankful always. the opportunity to pursue this mission and our life's work. This story highlights just some of the reasons we continue to perform well in perhaps the most challenging operating environment of our lifetime. And our procedures are safe, effective, fast, easy to perform, and require limited hospital resource. This is even more important in the current environment with significant shortages of staff, hospital beds, and ICU beds. While COVID might continue to wax and wane, we believe that these resource limitations will persist into 2022. We believe our clinical and economic value proposition will continue to resonate through and well beyond the pandemic. One final postscript to this story. The physician who treated this patient shared the story with his peers and the administrators of the hospital first visited by this patient. And I'm happy to report they now are also using SlowTreater. I'd like now to turn our attention to our Q3 financial performance. Our revenue in Q3 was $72.9 million, up $34.2 million or 88% from the same quarter last year, and up $9.4 million or 15% from Q2. Procedure growth was robust. Our physician customers performed approximately 6,700 procedures, including a modest number of cases from Europe. This procedure count is up from 5,900 or about 14%, from Q2. We believe that COVID associated procedures represented about 11% of the total volume of procedures, similar to the 12% of COVID associated procedures we saw during the previous surge in Q1. Growth in those patients whose VTE is not associated with COVID was 8%. Assuming we see the ongoing abatement of COVID, we anticipate a tempering of the number of COVID associated procedures during Q4. Regardless, We expect to drive robust procedure growth within our core TAM as we have demonstrated throughout this pandemic. Despite the continued questions about COVID and its impact on our business, we have made steady progress on all of our growth drivers, and we have grown in every single quarter since the pandemic began in Q1 of 2020. In fact, during the pandemic, we've completed over 30,000 procedures and nearly tripled our quarterly production of both cases and revenue. We added 500 new customer accounts, hired and trained over 100 new sales professionals, developed our VTE excellence program to drive deeper adoption, created and executed our Clot Warrior Academy online training and education platform, which has now reached over 4,500 customers. We enrolled over 800 patients into our Flash and Cloud registries, published over 100 studies in peer-reviewed journals, initiated our FLAME trial to prospectively study flow treatment for massive PE patients, and announced the peerless randomized controlled trial for intermediate risk PE patients. We drew seven new products, obtained an important new clinical indication to expand our TAM, and successfully launched all of our devices in Europe. And while it has not been our goal, we've accomplished all of this while maintaining positive cash flows from our operations. We believe all of this suggests that our technology has tremendous impact on patients. Our value proposition resonates broadly and consistently, and our team executes regardless of external circumstances. We remain focused on building our company for the long haul, and we believe we can and will continue to execute effectively and grow aggressively. I'd now like to share with you more specific and recent progress we continue to make on all five of our growth drivers. Our first growth driver is the expansion of our sales organization to target new hospitals and physicians. The size of our core TAM is large, as you know, and despite our continued growth, We believe that only about 6% of all patients in the U.S. who can and probably should benefit from our procedures were actually treated in Q3. Our efforts to penetrate this market will require a lot more sales professionals. Earlier this year, we shared with you that we are targeting 180 to 200 territories by the end of the year. We remain on track to comfortably land in the high end of this range. Our second growth driver is building awareness and driving deeper adoption at existing hospital customers. As you know, a high percentage of our target PE and DVT patient populations are currently treated with anticoagulation alone. Education and training of the non-interventional physicians who are often responsible for treatment decisions for these patients is important, and we continue to engage these physicians effectively. We are also working with administrators to establish systematic processes to identify and triage VTE patients consistently to the VTE experts. is to establish systems like those adopted for stroke and heart attack patients. Altogether, these efforts, which we have designated our VTE Excellence Program, are yielding encouraging results. More centers, for example, are establishing VTE coordinator positions every quarter, and penetration rates at targeted centers are climbing. We look forward to providing updates as we continue to execute the program. Our third growth driver is to build upon our base of clinical evidence. We again have a lot to share on this topic. Data from the first 500 patients enrolled into our FLASH registry were presented at the TCT conference last week. This study already represents the largest ever prospective interventional data set in the field of PE. The data confirmed the best-in-class safety profile of flow trigger system, impressive on-table clinical improvement, while the median ICU stay remains zero days. Perhaps more exciting, As we are now reporting patient data out to six months, we believe that treatment with FlowTriever fundamentally changes the natural course of this disease. All-cause mortality at all points of follow-up, as well as the rates of CTEF and CTED, which represent the terrible long-term consequences for survivors of this disease, are orders of magnitude better than those reported in the literature for PE patients treated with conservative medical management. In a separate study recently published in a high-impact peer-reviewed journal, Dr. Buckley and colleagues reported the first-ever comparison of PE patients treated with a thrombectomy device, the FlowTriever, to patients treated with anticoagulation analytics. The results are impressive. Patients treated with FlowTriever showed an 85% reduction in in-hospital mortality and a four-day reduction in ICU stay. Finally, we are pleased to report that a peerless randomized controlled trial comparing Flosraver to catheter-directed thrombolysis remains on schedule. The protocol is complete. Site selection is underway, and we expect first patient enrollment in Q1 of 2022. Our fourth growth driver is to expand our product portfolio. Exciting developments here as well. First, Flosaver has lived up to expectations. As a reminder, Flosaver is a device used to simply return blood aspirated during a flow saver procedure to the patient, allowing virtually bloodless thrombectomy. This is important because it enables the physician to whoosh as many times as necessary without concern for blood loss. Estimated blood loss per procedure, in fact, is down by 80%, even as the number of whooshes per procedure has increased by 33%. Adoption has been brisk. Flow saver has already been used in nearly 2,500 procedures. Bloodless thrombectomy It's highly valuable for physicians and patients, and it sets a high performance bar for both existing and future competitors. Next, we received FDA clearance for the clot-treater BOLD in October. The BOLD is a more aggressive clot-treater system which may allow us to treat older clots and more advanced DVT. In fact, it represents the first in a suite of products we will bring to market over time to treat patients with post-thrombotic syndrome, or PTS. PPS is a horrendous progressive condition that develops in about half of all untreated DVP patients and often results in venous leg ulcers. There are at least one million patients in the United States right now with venous leg ulcers, and PPS is the cause of about 60% of them. We'll have more to say about Clotriever Bold along with the remainder of our robust product pipeline over the coming quarters. Our fifth and final growth driver is expansion. into adjacent and international markets. The operating environment has stabilized across Europe, and we continue to make progress on launching this business. We have successfully established a commercial presence across all major European markets through a combination of direct teams and third party distribution partnerships. Enthusiasm and feedback from physicians remain highly positive, and we are seeing steady increases in our monthly case volumes. In addition to supporting and driving initial cases, We are also gaining clarity and executing on longer-term clinical and reimbursement strategies we will need to help build out our European franchise. Beyond Europe, we're making progress on regulatory paths in both Japan and China, although the approval timelines remain years away. We remain very optimistic about the longer-term potential for our international business, but we believe it will not materially contribute in the immediate term. Finally, I appreciate always the opportunity to close by reminding you that our work here is more important to us than just business. We are committed to a mission. We appreciate you believing along with us in extraordinary possibilities, and we appreciate your continued support. We are just getting started. We believe we can and will grow sustainably and aggressively for many years to come. With that, I'd like to turn things over to Mitch.
spk07: Thank you, Bill, and good afternoon, everyone. Inari revenues for the third quarter of 2021 were $72.9 million, compared to $63.5 million for the prior quarter, and up $34.2 million, or 88% from $38.7 million for the same period of the prior year. Compared to Q3 of 2020, we have expanded our sales force, opened new accounts, and achieved deep penetration of our products into existing accounts. Revenue was split between our two products as follows. 30% of our revenue was derived from the sale of clot treatment products during the third quarter of 2021, compared with 37% in the third quarter of 2020. And 70% was derived from the sale of flow treatment during the third quarter of 2021, compared to 63% in the same period of the prior year. During Q3, the vast majority of our revenues came from procedures. Our stocking revenue was consistent with the level we saw during Q2 of 2021 due to the broad acceptance of several of our new products, including the Flow Saver, which we introduced in Q3 of 2021. We expect our stocking revenue as a percent of total revenue will moderate over time. Gross margin was 90.3% for the third quarter of 2021, compared with 91.7% in the third quarter of 2020. The 140 basis point decline was due primarily to a change in inventory management in anticipation of our facility move. Operating expenses were 68.6 million in the third quarter of 2021, compared with 28.3 million for the same period of the prior year. R&D expense was 12.5 million in the third quarter, compared with 5.2 million in the same period of 2020. The 7.3 million increase in R&D expense was primarily driven by an increase in headcount, as well as product development and clinical evidence development costs. SG&A expense was $56.1 million in the third quarter of 2021, compared with $23.1 million for the same period of the prior year. The $33 million increase was primarily due to personnel-related expenses as a result of increased headcount across our organization, travel expenses, and sales and marketing costs. As a reminder, Q3's SG&A expense, net loss, and net loss per share include the impact of an 8.3 million one-time non-cash stock-based comp charge. Net loss for the third quarter of 2021 was 2.8 million, compared with net income of 6.5 million for the same period of the prior year. The basic net loss per share for the third quarter of 2021 was 6 cents, based on the weighted average basic share count of 50 million. The fully diluted share count as of the end of Q3 was 55.5 million. This compares with a basic and fully diluted net income per share of 13 cents and 12 cents, respectively, and a weighted average basic and diluted share count of 48.3 million and 55.4 million, respectively, for the same period of the prior year. I'd like to move on to a few balance sheet updates Our cash of 81.2 million and investments of 87.4 million at the end of Q3 2021 totaled 168.6 million compared to 164.2 million at the end of the fourth quarter of 2020. We have not yet utilized our 30 million revolving credit facility, although we ended the third quarter with borrowing capacity under the credit line of approximately 28.2 million. Our cash was used in operating activities for $5.6 million in Q3 of 2021 compared to cash generated by operating activities of $7.3 million in Q2 of 2021. On a sequential comparison basis, our cash used during Q3 relates primarily to investments in our new production and office facility. I'll close my comments by addressing Inari's financial guidance. we are comfortable increasing our full-year revenue guidance to $266 to $268 million, up from our previous guidance of $250 to $255 million. With that, I'd like to turn the call back to the moderator for questions.
spk00: Thank you. To ask a question, you will need to press star then 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Cecilia Furlong with Morgan Stanley. Your line is now open.
spk05: Great. Thank you for taking the questions. Bill, I wanted to start with Flow Saver and just see if you could provide a bit more commentary around what you've seen from an adoption standpoint today just in terms of procedures utilizing it. And then as you look out forward as well, just the ability for Flow Saver to expand your user base bring physicians off the sidelines who are reticent to use FlowTruver due to concerns around blood loss?
spk08: Yeah. Thanks, Cecilia. Good to talk with you. Just as a quick aside here, we have joining me for questions and answers, maybe even this question, our Chief Operating Officer, Drew Hikes, and Dr. Tom Tu, who is our Chief Medical Officer. So thanks for the question. So first of all, the adoption has been brisk, as we communicated in the Q&A. in the prepared remarks. It is, in the hospitals that already have Flow Saver, the percentage is very, very high. I would say almost all cases, in almost all centers that have Flow Saver, if they're doing more than one whoosh, they're probably using Flow Saver. So these very, very high rates of adoption. The centers that don't have Flow Saver on the books, in the hospital just yet, That is a function mostly of the administrative challenges of going through value analysis committees and so forth, but because it's part of the per procedure pricing, there's not an additional cost, so these are purely administrative hurdles and we'll get through them. We do actually believe already that we've seen some people pick up FlowTriever because the risk is lower. potential for multiple whooshes with a much lower consequence for just missing is lower. There's essentially no consequence for that. So, yes, we actually believe that this is not only exciting for our current user base, but that it is a driver of adoption.
spk05: Okay, great. And I wanted to ask, too, just on your comments around the OUS expansion, what you've seen in the quarter, But if you could talk a bit more about just your outlook today around both the clinical and reimbursement work needed to really open up some of those markets, especially in Europe, over the next several years. And thank you.
spk02: Yes, Cecilia, it's true. I can get started on that one. So not a whole lot to add beyond what you heard Bill describe in the prepared remarks. We like what we're seeing so far in Europe. Lots of positive momentum. We've done cases now across most of the major European markets. We're doing cases every day now, essentially. The monthly trends are positive, incremental growth month after month, and lots of enthusiastic feedback from the physician community. We are getting more clarity on the reimbursement and clinical work that we're going to need to do market by market, to really put ourselves in a position to drive broad adoption of both technologies. In some cases, that will look like dedicated clinical studies we'll need to do in some of those markets to submit that evidence to the reimbursement authorities and gain broad-based reimbursement. So those strategies are coming into view in some of those markets. That's going to take us a number of quarters to complete that work. In the meantime, we are going to be able to access and continue to access opportunistically more account level and regional level budgets, which will allow us to continue to do cases and expand the franchise, even as we undertake that longer-term reimbursement clinical work that I described. So having said all that, we still view this as a longer-term growth driver for us and wouldn't anticipate the international business being a material contributor to the overall commercial franchise, you know, really for the foreseeable future. So we'll continue to keep you posted on the progress, but for now, we like what we're seeing.
spk05: Great. Thank you for taking the questions.
spk00: Thank you. Our next question comes from the line of Larry Regelson with Wells Fargo. Your line is now open.
spk06: Hey, guys. Congrats on a nice quarter here. Thanks for taking the questions. I just wanted to start, you guys obviously had a great quarter, but I'm trying to understand the bridge from Q3 to Q4 implied in the guidance. So, you know, maybe talk about stocking a little bit. We estimated about $12.5 million in Q3. Is that close and how should we think about, you know, what's implied in Q4? And Mitch, I heard your comments on it moderating over time, but just comments on 2022 stocking would be helpful. And just lastly, the COVID assumption for Q4. Just the pieces, the moving parts on stocking and COVID and anything else we should understand on kind of the implied 1% sequential growth in Q4. Thanks.
spk07: Sure, not a problem, Larry. And the stocking figure you quoted is really pretty much right, kind of that 12.5 million range. So I think that's something that we see as being pretty consistent with where we were in Q2 on a percentage basis, certain percent of total revenue that, you know, speaks to the really strong acceptance that we've had in the marketplace, you know, from the T24 and the T20 curve and the FT2 and some other, the flow saver, obviously, which we just talked about with Cecilia. From a 2022 point of view, I made the comment about moderation in stocking revenue. I think You know, moderation is sort of a term of art, obviously. We are very excited about the product announcement memo, sort of menu for 2022. We'll get into that, you know, obviously in a lot more detail as we turn the page on the new year. And we believe we'll continue to have some strong acceptance by our customers of these new products. That does generate some one-time technical upgrade revenue. But I think as the number of accounts grows and basically the base of procedural revenue grows in the business, the stocking revenue will inevitably fall as a percent of total. So I hope that helps a little bit. In terms of our Q4 guidance, I think you're kind of also focusing and asking about that a little bit. Maybe I can get this started and Bill and Drew can jump in and help with it. But we're very pleased with where we are in terms of thinking about Q4. And obviously, to be able to raise by a significantly greater amount than we beat, that's a nice thing. And we think that stocking could play a part in Q4 in terms of potentially a little bit of a headwind, as well as the reduction in COVID procedures and things of that kind, the hospital staffing shortages. There's three or four factors that kind of go into our thinking about that. And, you know, we, of course, don't want to get ahead of ourselves in terms of our guidance, and we felt comfortable that that's a good number and hopefully one that will be helpful to you and others in terms of thinking about the business short term. You know, the more important thing, I think, is just the long-term potential for the business, and we're, frankly, more excited than ever. You know, we probably treated still about 6% of the patients in Q3 who could have been helped, with the use of our various products. And there's so much opportunity there for us in the future that we couldn't be more excited about that and to be a part of it.
spk08: Yeah, I guess the only thing I'd add there, Larry, is that we are, I guess, as frustrated as anybody with the waxing and the waning of the pandemic and the COVID surges and the challenges that creates. And so, you know, we're facing exactly the same sets of headwinds that everyone else faces with regard to, you know, staff shortages, limitations to hospital resources, you know, procedure volumes are down in many hospitals, whole cath labs taken out, all those challenges. And yet, we have been able to grow, right? Even if you eliminate completely... if COVID did not cause VTE and we didn't see any sort of, you know, amplitude on those sorts of patients, I think we'd be very pleased with an 8% growth sequentially from Q2 to Q3, especially given all these challenges that everyone's facing. And, you know, at some point here, we think the operating environment is going to return to some sort of normalcy, and we think we can do even better, right, when we have, you know, full bandwidth and access So right now, I think what you're seeing with the Q4 implied guidance is we just want to make sure that we never, ever overpromise, and we want to acknowledge also the uncertainties that remain out there while at the same time acknowledging the fact that we do continue to execute in the penetration of our core TAM very, very effectively.
spk06: That's very helpful. Thanks, Bill. Obviously, you guys in September talked about transforming the company. I can't remember exactly what you said, but I'm pretty sure you used the word transform, which is obviously something we don't hear every day from a CEO. I guess my questions are, how are you thinking about adjacencies? Is this organic versus inorganic? When are we going to learn more, and do you have an analyst meeting or investor meeting set for 2022, and I might try to slip one more in if you let me. So go ahead.
spk08: Wait, you're already at seven or eight, Larry. I know. It's okay. We get it completely. So I'll see if I can get all these in. You remind me, since I have ADD, you'll have to remind me if I miss them. But I think you're starting to see now a cadence of products. There's a bit of a track record now. I think we talked about seven ahead of this call, seven new products. And this one, the Clot Tree for Bold, is the first in what we believe a series of products. It's a really challenging disease state, old clot. It's really not clot, it's scar tissue, and eventually it causes post-thrombotic syndrome. I think you'll see us working on that market, communicating a bit more in terms of numbers of patients, a very, very large market, and our ability to address that market over time and Again, it's a challenging disease state, so we'll see. But that's the first, and we believe there are several other new products that are coming down the line here. All of you have been very patient with us. We don't want to break any new news here. But, again, these things are beginning to materialize now, as you're seeing with Clutch River Bold. So there will be a number of other adjacencies there. that we enter. We're not going to talk at all about inorganic opportunities, pro, con, when. We're just not going to comment on those things for obvious reasons. Did I miss any questions there, Larry? Is there another one?
spk06: Analyst meeting for next year?
spk08: Analyst meeting. We're not quite ready to communicate a date, but we have shared with, I think we've shared publicly that we do plan at some point in the probably the first half of the year, to do an analyst meeting. So we're working on dates now, and we'll have some things to say about that shortly.
spk06: Just lastly on BOLD, I just wanted to follow up. What is the status of the launch? How are these patients treated today? What makes BOLD appropriate for them? Thanks for taking the questions.
spk02: Yeah, Larry, it's true. I can get started on that one. So we are in the early phases of what we call the LMR, the limited market release for BOLD, We got clearance here just at the end of October, so we're still in the early days. We've done, I don't know, a dozen or so cases, so still very early in understanding how that product performs in some of these longer-term patients that have these PTS-related ulcers and the longer-term kind of scar as opposed to clot. Those patients today don't have great treatment options. That's why there's such a dramatic unmet need for that particular patient population. They suffer from severe PTS. Many of them have ulcers and wounds that are unhealed. Their quality of life is atrocious, and they get kind of passed around the system without anyone being able to offer definitive treatment. And that's exactly the unmet need that we've identified and what we hope we're going to be able to address over time Claptuber Bold, as you heard Bill describe, is really the first of what we envision as a system to try and help those patients. So still early days. We're just getting started on the LMR, and we'll keep everyone posted as we learn more about how that product is performing out in the market in these patients.
spk06: Thanks, Drew. Thanks for taking all the questions, guys.
spk08: Our pleasure. Thanks, Larry.
spk00: Our next question comes from the line of Bill Plavanik with Canaccord. Your line is now open.
spk10: Hi, it's Sean for Pill Tonight. Thanks for taking our questions. First, I just wanted to ask, have you had any discussions regarding CMS removing the NCD for transvenous catheter pulmonary embolectomy or any subsequent discussions with payers or administrators since that decision?
spk02: Yeah, so this is Drew again. I can give you some quick updates on the NCD. Good news there. About two weeks ago, CMS announced publicly that they were removing that NCD effective immediately. So that NCD 240.6 no longer exists. It was never a particular overhang for our business, more of a distraction really over the last couple years. But nonetheless, we were pleased to see CMS respond to Numerous physician societies and dozens and dozens of individual physicians that had all advocated for removing that NCD that stretched back to 1983. We have proactively reached out to a handful of the private commercial payers that had reference to that NCD within their systems and updated them that it has now been removed. So all that has taken place over the last couple of weeks. But again, it was not necessarily at all a headwind or an overhang for the business. So we haven't seen any impact commercially other than clearing up that distraction and avoiding having to spend any time or additional bandwidth describing it or talking about it.
spk10: Great. Thanks for that, Collar. And then can you also talk about the runway for continued penetration and existing accounts and perhaps how many accounts today are only using FlowTriever or only using PlotTriever? Thanks.
spk02: Yeah, so we're in about 1,200 accounts active here in Q3. So we added a similar number of new accounts that you've seen us add on a quarterly basis. That 1,200 accounts, over 60%, almost two-thirds actually, are using both technologies, which obviously means there's 30-some percent that are using only FlowTriever or only ClotTriever. And it's really a mix, a pretty balanced mix, those single technology accounts. So that's the status as of Q4. We continue to make progress on pulling in those second technologies into the accounts where we have that opportunity. And the vast majority of our case volume is coming from existing accounts, from driving deeper penetration. Over 90% of our cases in the quarter came from those existing accounts. So that second growth driver that we talk about, I think, is increasingly important to driving the growth, and that's exactly what we saw here in Q3. Great.
spk10: And then if I could just sneak in one more for you, Drew, to probably – Just the field force size exiting the quarter?
spk08: Yeah, I think we communicated in the prepared remarks that the previously projected 180 to 200 territories by the end of the year, that we were on pace to kind of finish in the high end of that range. So I think we'll leave it there without any... Hopefully it's okay to leave it there without any further detail. But we've had no... no, I mean, it's always a challenge to hire and training and onboard, but we've had no, you know, COVID-related additional challenges. We've been very crisp with the execution of our, you know, hiring, training, and onboarding program.
spk10: Great. Thank you for taking our questions.
spk08: Thanks, Sean. Thanks, Sean.
spk00: Thank you. Our next question comes from the line of Marie Thiebaud with BTIG. Your line is now open.
spk03: Hi. Hi, Laurie team. Congrats on a strong quarter, and thanks for taking my questions tonight. I wanted to start here, I guess, with a follow-up on BOLD and just try to clarify, you know, reading a little bit about the design of the catheter. I'm curious whether post-thrombotic syndrome is included in the label, and if so, what clinical data was sort of introduced there to win that?
spk08: We can, you want to start with the labeling, Drew?
spk02: Yeah, so that product, the design is really very similar in a lot of ways to the existing clot tree burr system. And the initial labeled indication here out of the gate mirrors what we have in place for the clot tree burr, kind of the core clot tree burr product itself. So no big changes there. Over time, again, as we get more experience with the product and understand how it's performing, We may decide to undertake some additional work to expand that labeling and update that labeling, but that's the status as of where we are today.
spk09: Maria, it's Tom here. I thought I might provide a little clinical background about post-thrombotic syndrome. You can imagine patients who are undertreated for deep venous thrombosis may end up having scar tissue and occlusion of their veins due to poor healing. And these patients really have no options. They're the ones with swelling in their legs chronically, non-healing venous ulcers, and the ability to modify the tissue, remove tissue, open up channels, reduce the venous pressure has resulted in healing of these venous leg ulcers in patients that we've already treated. So we're really excited to explore this new market of patients that we hope to benefit, but I think we're quite early on in this experience.
spk03: Okay, that's great to hear. I appreciate that color. And then if I could ask here on staffing shortages, we've been hearing across this quarter from several MedTech peers that staffing shortages have led to kind of constraints on procedures, and I'm curious what the impact was, if any, on ANARI this quarter.
spk08: Yeah, thanks, Maria. I think the answer is it's really hard to measure. So we hear anecdotally for example, that, you know, this hospital or that had to close down one of their labs or a couple of their labs or they had to close early and they're trying to manage procedure volumes in the cath lab, you know, pulling nurses from one place or another, you know, hiring traveling nurses. There's any number of anecdotal challenges, and I suspect you've heard this from some of our peers. The fact is, however, even in our core TAM, we continue to grow pretty robustly. And I think the key here is that some procedures are getting done, right? And I think our procedures carry a profile, and our patient population carries a profile that is kind of a little bit higher in the priority. A lot of our patients, especially the PE and a pretty significant percentage of the DVT patients, are not considered patients. They're considered emergent. And so that's one part of this. The second part, of course, is that our procedures are fast and easy to perform and require limited hospital resource. So there's no ICU stay that's required. We believe pretty strongly in a lot of our hospitals, their own metrics suggest these patients leave the hospital a little bit more quickly. And I hinted at that with the patient story that I shared a little earlier as well. These are the sorts of procedures that are getting done based on characteristics of the patient, high acuity setting, emergent type setting, and the characteristics of the procedure, just requiring limited resource. And I think secondary to all of that, but important for hospitals that continue to be, you know, kind of financially burdened by the pandemic, nobody's losing money on these procedures, and I think that's an important component.
spk03: That makes sense. Okay, makes a lot of sense. One last quick housekeeping one, if I can sneak it in. I heard the 6,700 total procedures or so this quarter. Do you have the split between DVT and PE procedures?
spk07: Yeah, the split, and I think this is also in the queue. From a revenue point of view, the split was 70-30, which I talked about. And the case for the quarter was 51% DVT and 49% PE procedures.
spk08: The difference is the weighting toward, as always, the weighting toward the PE in terms of revenue is primarily based on average selling prices being a little higher in PE as well as PE devices. The flow trigger is often used in DVT procedures and it's often in combination with clot triggers. So That's why it represents a little bit higher percentage of revenue than procedures.
spk03: Perfect. I appreciate the time tonight.
spk08: Thanks, Maria. Thanks, Brie.
spk00: Thank you. Our last question comes from the line of Danielle and Telfie with SBB LRINC. Your line is now open.
spk01: Hi, guys. This is Priya on for Danielle. Congrats on a great quarter, and thanks for taking the questions. I have a one kind of a follow up from from the last one, you know, just understand that the there's a higher mixed for flow Trevor in the quarter kind of related to, you know, ASP. But you know, are you guys seeing anything within the quarter? And within the market, that's from like a competitive dynamic, or even code related, that's raising a higher awareness around PE. And then another follow up for me.
spk08: You want to take the awareness, Tom?
spk09: Sure. So, you know, we've talked a lot about COVID influencing the incidence of disease, as well as perhaps being a headwind in many systematic ways. But one thing is certain, that COVID has done nothing but increase awareness about blood clots in general. I would not say that there's a predilection for pulmonary embolism over DVT in terms of the awareness issue. I think both of these are diseases associated with COVID and are now part of the common parlance.
spk01: Great. Thank you for that. And just another one from me here. It looks like procedures increased about mid-single digits, quarter over quarter, ex-COVID impact. Is that the right way to think about it, about the underlying growth, or is there any seasonality factor in here?
spk02: Yeah, so I think you heard Bill describe in the prepared remarks that the procedure growth in our core TAM was 8%, so even higher than the number you quoted. So we like what we saw. We continue to execute, we think, crisply across the board, and you're seeing that reflected in the core TAM. All those growth drivers that we discussed remain intact, and we continue to make good progress across the board on each of them. And I think taken together, that's what's contributing to the kind of growth that we're able to demonstrate in Q3, and I think gives us some confidence heading into the end of the year.
spk01: Great. Thank you.
spk08: Thanks, Priya.
spk07: Thanks, Priya.
spk00: There are no further questions at this time.
spk07: Very good. Thank you. Thanks, everyone. Thanks for joining us.
spk00: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
Disclaimer