Penumbra, Inc.

Good afternoon. My name is Adam, and I will be your conference operator today. At this time, I would like to welcome everyone to Penumbra's third quarter 2023 conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press the pound key again. Thank you. I'd like to introduce Ms. G. Hamlin-Harris, Investor Relations for Penumbra. Ms. Hamlin-Harris, you may begin your conference.

Thank you, Operator, and thank you all for joining us on today's call to discuss Penumbra's earnings release for the third quarter of 2023. A copy of the press release and financial tables, which include the gap to non-gap reconciliation, can be viewed under the Investors tab on our company website at www.penumbrainc.com. During the course of this conference call, the company will make forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding our financial performance, commercialization, clinical trials, regulatory status, quality compliance, and business trends. Actual results could differ materially from those stated or implied by our forward-looking statements due to certain risks and uncertainties, including those referenced in our 10-K for the year ended December 31, 2022 files with the SEC. As a result, we caution you against placing undue reliance on these forward-looking statements, and we encourage you to review our periodic filings of the SEC, including the 10-K previously mentioned, for a more complete discussion of these factors and other risks that may affect our future results or the market price of our stock. Penumbra disclaims any duty to update or revise our forward-looking statements as a result of new information, future events, developments, or otherwise. On this call, certain financial measures are presented on a non-GAAP basis. The corresponding gap measures and a reconciliation of gap to non-gap financial measures are provided in our posted press release. Adam Elsesser, Penumbra's Chairman and CEO, will provide a business update. Maggie Ewan, our Chief Financial Officer, will then discuss our financial results for the third quarter. And Jason Mills, our Executive Vice President of Strategy, will discuss our 2023 guidance. With that, I would like to turn over the call to Adam Elsesser.

Thank you, Chi. Good afternoon. Thank you for joining Penumbra's third quarter 2023 conference call. Our total revenues for the third quarter were $270.9 million, a year-over-year increase of 26.8% as reported and 25.9% on a constant currency basis. Our worldwide thrombectomy business achieved record revenue of $179.1 million growing 38% on a year-over-year basis. Our worldwide embolization and other revenue was $91.9 million, increasing 9.5% over the same period a year ago. Our global vascular thrombectomy business led our growth, increasing 56.9% year-over-year, while neurothrombectomy grew 10.3% year-over-year. We had another very strong quarter in the United States, as revenue of $194.8 million grew 30.9% year over year, led by total U.S. thrombectomy, which increased 42.1% year over year. Our strong growth in thrombectomy this quarter, during which we did not have new product launches as we've had in the first two quarters of the year, shows how demand is building for our computer-assisted vacuum thrombectomy and stroke products. In fact, we expect our total thrombectomy growth, both in the United States and globally, to accelerate slightly in the fourth quarter on a year-over-year basis, and we expect growth in embolization and access to be similar to the third quarter. We expanded our gross margins in the third quarter to 65.6%, strong revenue growth and gross margin expansion, coupled with disciplined operating investments and commercial execution, made the third quarter the most profitable quarter in our company's history. Non-GAAP operating income was a record $33.2 million, representing 12.3% of revenue. We posted record adjusted EBITDA of $51.5 million, or 19% of total revenue, compared to $14.6 million last quarter and 8.9% in the third quarter last year. We also grew our operating cash balance by $27.8 million sequentially. Looking forward, we expect to deliver strong revenue growth, gross margin expansion, increasing profit margins, and strong cash flow in 2024, 2025, and beyond. Penumbra is the largest thrombectomy company in the world, and developing proprietary technologies To take thrombus out of the body, wherever it is, from head to toe, has always been our mission. Almost 20 years of incremental innovative successes have led to this transformational moment in our company's history and the thrombectomy market. We have now successfully developed proprietary computer-assisted vacuum thrombectomy products that optimize the three most important elements of clot removal. Safety, speed, and simplicity. Lightning Flash and Lightning Bolt 7 and Red 72 Ascendant are currently driving our momentum. Because of these products, we expect to achieve an extraordinary milestone during the fourth quarter. We expect to treat more than 100,000 clot patients in the United States during 2023 alone. with our thrombectomy products. We obviously still have a long way to go to help the 1,250,000 patients each year in the U.S. that have significant clot burden, but this is a notable achievement for our physician customers and our team. In vascular thrombectomy, we had a strong third quarter. Lightning Flash and Lightning Bolt 7 delivered strong growth for our U.S. arterial and venous franchises. This success was achieved with over 1,200 total customer accounts, which we define as hospitals using either Flash or Bolt. So in some cases, hospitals are counted twice if they are using both products. As an update on the number of pending accounts, which are in addition to those I just mentioned, we succeeded in obtaining well over 650 new VAC approvals last quarter for Flash or Bolt. and these accounts are now working through the typical supply chain process prior to placing their initial orders. We expect many of these customers to order and begin using Flash or Bolt this quarter. In addition, we currently have at least 600 additional accounts that are still working through the initial VAC process, and we expect most of those accounts to order in Q1 or Q2 of 2024. Therefore, we expect the majority of our potential customer base will have flash or bolt on their shelves during the first half of 2024. Once these products are available and starting to be used, our work shifts to going deeper with training and increasing the use of CAVT in cases that currently use open surgery or lytic as the primary mechanism. So far, the reorder rates for both flash and bolt are as high as any product we've ever launched in thrombectomy. In stroke thrombectomy, we are gaining share from our already majority position. REDD72 with SENDIT technology is still early in its adoption curve as many hospitals work through the submission process for this product as well. We currently estimate that we have over 55% share of the US stroke market for aspiration catheters compared to 28 other aspiration catheters that are competing against each other in the rest of the market. Looking forward, we believe our new technology for both the front end of the stroke procedure, namely trackability with Red72 SendIt, coupled with our innovation for the back end of the procedure, clot extraction with Thunderbolt, can drive our share to 70% plus over the next several years. The two questions we get asked the most by investors are, first, are we ready to meet this moment of opportunity in thrombectomy? And second, what specific work is Penumbra doing to bring CAVT to the other 90% of patients who aren't receiving thrombectomy today? The answer to the first question is yes. I am confident that our team understands the serious work ahead and is able to meet the moment and think bigger than ever before. Now, without sharing competitive information, let me outline the specific areas of work ahead. Our work is focused on three areas, innovation, internal readiness, and implementation of market access work modeled after the historically best companies' work for long-term sustainable growth. First, our innovation pipeline is robust. We are hearing from our physician customers as well as hospital systems that computer-assisted vacuum thrombectomy is the future standard for thrombectomy. Over the next 18 months, we plan to launch four new CAVT products in the United States. Coupled with FLASH and BOLT7, we expect our CAVT portfolio will drive both market share and market growth in DVT, PE, and arterials. In addition to these new products coming in the near term, we have made significant advancements with next generation technology that could expand both the scope and dominance of our CAVT platform over the long term. We will talk more about these developments in the future, but for now I will say that these technologies will be integrated into our CAVT platform and will be able to provide unique benefits to our physician customers and their hospitals, including further optimizing patient outcomes and physician use. The second area is internal readiness. We have already started serious work on efficient manufacturing at scale, which includes raw material acquisition, stable supply chain, and efficient capacity utilization. We have also started the work to bring even more efficiency and scale to our customer and sales field support teams, enabling faster order processing time in all time zones. And of course, we are focused on evolving our commercial team, particularly in vascular. Currently, our team has a lot to focus on, launching two new transformative products in thrombectomy, plus continuing to grow with our current coronary thrombectomy product, and our market-leading embolization portfolio. With an appropriate investment that we believe marries well with our movement to stronger profitability, we will evolve the commercial team over the next two quarters, putting the team in an even stronger position to take advantage of the opportunity in 2024 and beyond in thrombectomy. Third, we are starting to implement a strong market access program based on depth and class historical programs focused on our computer-assisted vacuum thrombectomy platform. Internally, we refer to this work as the Penumbra CAVT Initiative, and it is being led by senior leaders across the organization, including Dr. Jim Beninati, our chief medical officer, and Dr. Venkat Tamala, our associate chief medical officer, working closely with senior leaders in the clinical specialties of interventional radiology, vascular surgery, interventional cardiology, and neurointervention, together with leaders in our reimbursement clinicals and commercial organizations, and in concert with external partners. We believe this initiative will substantiate the advantages of our CAVT platform over the long term. With the important work we are doing in innovation, internal readiness, and market access, we are well on our way to bringing computer-assisted vacuum thrombectomy to all hospitals treating patients with blood clots across every vascular bed from head to toe in the United States now and internationally as these products become available in the years to come. Indeed, in the United States where we have lightning flash both and send it, our thrombectomy business will comprise about 67% of our domestic revenue in 2023 and we expect it to grow to over 70% in 2024. By contrast, our thrombectomy franchise outside the US will represent approximately 55% of our international sales in both 2023 and 2024, after which we expect our new CAVT portfolio products will influence our international growth as it is in the US today. Our growth potential over the next several years is significant. with our commercial focus on thrombectomy globally, plus where there are opportunities for profitable growth in embolization and access. And we are in the early stages of strong operating leverage, while we still make the important investments focused on these three areas. The road ahead won't be a straight line, nor will it be free of challenges. But if we continue to do the right things, think bigger, and work purposefully, we can help many more patients while stewarding a growing profitable business over the next several years. I'll now turn the call over to Maggie to go over our financial results for the third quarter.

Thank you, Adam. Good afternoon, everyone. Today I will discuss the financial results for the third quarter of 2023. Financial results on this call for revenue and gross margin on a GAAP basis while operating expenses and operating income on a non-GAAP basis. The corresponding GAAP measures and our reconciliation of GAAP to non-GAAP financial measures are provided in our posted press release. While the third quarter ended September 30th, 2023, our total revenues were $270.9 million, an increase of 26.8% reported and 25.9% in constant currency compared to the third quarter of 2022. Our geographic mix of sales in the quarter was 71.9% U.S., and 28.1% international. U.S. reported growth of 30.9%, and our international regions increased 17.4% reported and 14.3% in constant currency. The sequential growth of 3.6% was primarily driven by an increase in our global thrombectomy business of $16.6 million, or 10.2%, offset by a decline in our embolization and other businesses of $7.1 million, or 7.2%, primarily driven by EMEA seasonality, timing of immersive healthcare milestones, and our distributor-customers mix. Moving to revenue by franchise, revenue from our vascular business grew to $171.4 million in the third quarter of 2023. an increase of 38.9% reported and 38.5% in constant currency compared to the same period last year, driven by 50.2% year-over-year increase in U.S. vasculothrombectomy. Revenue from our neural business was $99.5 million in the third quarter of 2023, an increase of 10.2% reported and 8.5% in constant currency compared to the same period a year ago, driven by strong performances in Europe and U.S. Turning to gross margin. Gross margin for the third quarter of 2023 is 65.6% compared to 63.3% for the third quarter of 2022 and 63.8% last quarter. The sequential improvement is driven by higher thrombectomy product mix, improvement in labor efficiencies, and a stabilized supply chain environment. Our operations team continue to execute to support the demand while focusing on these production initiatives that will result in future production efficiency. While we will accelerate our productivity and scalability investment in the next few quarters, we expect these investment costs will be offset by product mix and continued productivity improvement in the near term, which will enable further margin expansion in 2024 compared to 2023 overall. Now onto our non-GAAP operating expenses, which excludes a one-time expense associated with the acquisition of IP R&D of $18.2 million for this quarter, and the amortization of acquired intangible assets of $2.4 million for this quarter, the same quarter last year, and last quarter. Total operating expense for the quarter was $144.5 million, or 53.3% of revenue, compared to $127.5 million of 59.7% of revenue for the same quarter last year and $146.6 million of 56.1% of revenue for last quarter. Our research and development expenses for Q3 2023 were $21 million compared to $21.3 million for Q3 2022 and $21.5 million for last quarter. SG&A expenses for Q3 2023 were $123.5 million of 45.6% of revenue compared to $106.2 million of 49.7% of revenue for Q3 2022 and $125.1 million of 47.8% of revenue last quarter. We recorded operating income of $33.2 million or 12.3% of revenue in the third quarter of 2023, compared to an operating income of $7.8 million, or 3.7% of revenue for the same period last year, and operating income of $20. million, or 7.8% of revenue last quarter. We continue to invest to support volume growth and long-term projects that allow us to continue to scale the organization into the future while creating a balance on discipline spend in the present. We believe it is worthwhile to highlight our adjusted EBITDA, which excludes a one-time expense associated with the acquisition of IPR&D of $18.2 million and stock compensation of $14.1 million, $12.8 million, and $9.7 million for this quarter, last quarter, and the same period last year, respectively. We posted record adjusted EBITDA of $51.5 million, or 19% of total revenue, compared to 14.6% last quarter and 8.9% in the third quarter last year. Coming to our cash flow and balance sheet, we ended the third quarter with a cash, cash equivalents, and marketable security balance of $248.9 million and no debt. which is an increase of $27.8 million from the last quarter. The sequential increase in cash is driven by an increase in profitability and improvements in working capital terms. And now I would like to turn the call over to Jason to discuss our guidance.

Thank you, Maggie, and good afternoon, everyone. For the fourth quarter of 2023, we expect total company revenue growth to accelerate to 28 to 31% year over year, which correlates to the midpoint of our annual guidance range of $1.5 billion to $1.7 billion for full year 2023. We expect global thrombectomy revenue growth to accelerate sequentially from the third quarter and expect our geographic mix of sales between the United States and international markets to be similar to the third quarter levels. I will now turn the call back to Adam for closing remarks.

Thank you, Jason, Maggie, and Chi. As CAVT becomes recognized as the future of thrombectomy, our team appreciates the serious and important work ahead. I outlined the initial phase of that work during my earlier remarks. With this opportunity in front of us, we are all in, as we proudly accept the challenge to meaningfully change the number of people who benefit from our innovative technology. Thank you. And thank you, Aubrey. We can now open the call to questions.

At this time, I'd like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. And your first question comes from Robbie Marcus with JPMorgan. Your line is open.

Hi, this is actually Lily. I'm for Robbie. Thanks for taking the question. Two quick ones, I'll ask them together. Why not raise the guide by at least a beat? Is that just conservatism or are there other dynamics we should be keeping in mind for the rest of the year? And related to that, reiterating the guide implies a softer fourth quarter than what the street was thinking. So what's the driver of that and how should we be thinking about the fourth quarter? Thanks so much.

Yeah, thank you for the question. I'll take that. This is Jason and then Adam can jump in if he likes. First, I would say that the expectation that our business will accelerate to the fastest pace of the year, 28 to 31% year-over-year growth, is really a positive reflection of the momentum we have right now. This guidance takes into account many things, the progress and timing with the new customers getting approvals and placing their first orders, timing of the new products and market development initiatives. But let me give you just a little bit more context on our guidance. Our thrombectomy business worldwide, as you saw, grew 38% in the third quarter. Our guidance anticipates global thrombectomy to accelerate to 40% plus growth in the fourth quarter. It also anticipates our U.S. thrombectomy business will grow even faster than this in the high 40% range. That said, while our embolization and access businesses are market-leading franchises, They are in more established markets, so we expect growth here will be in the high single digits, which is similar to the third quarter. As we move forward, more and more emphasis, as you can probably hear across the organization, will be on thrombectomy, where markets are underpenetrated and where we have a platform technology with CAVT that we believe will be the future standard. So overall, we're excited about where we're going.

The next question comes from the line of Larry Beagleson with Wells Fargo. Your line's open.

Hi, it's Leigh calling in for Larry. Thanks for taking the question. One for Adam. Adam, recently you talked about 20% plus sales growth outlook for 2024. Can you just comment on your confidence on that outlook and what are the key drivers on the back of your strong Q3 report? And if I may have a follow-up on that, you previously expected to exit this year, you know, with mid-60% growth margin, low double-digit operating margin. You obviously already got there in Q3, so if you can comment on how you think about that, exiting the year and into 2024. Thank you.

Yeah, thank you, Leigh. Let me start with the 2024 guidance. We are very confident in what I said actually at your conference as at least 20%. Our plan is to give formal guidance on our fourth quarter call, which is our typical pattern. And at that point we can give the nuance around that specific guidance. But obviously if you hear what we're saying about the business and how it's setting up, we're obviously very confident. in that at least 20% number. As it relates to the profitability margin, I will comment briefly and then Maggie can comment more specifically. It is really important for us to run a profitable business and to increase that profitability. That has been something we've prided ourselves in a long time and now more than ever. I think the world is agreeing with that, that profitability is a very important measure. You heard it in the prepared remarks. We're setting ourselves up to run this to be more and more profitable, but Maggie can be more specific.

I feel really good about our profitability trend. More important to note is we are reaching a sustainable level of profitability, both in growth margin and overall operating margin. We will continue to invest in investment in a number of initiatives, but as I mentioned earlier, with the trend of increasing thrombectomy product mix, we continue to scale and leverage the overhead. We expect to continue to see growth margin and overall margin expansion moving forward for next quarter and in the longer term. Thank you.

Your next question comes from the line of Margaret Kaiser from William Blair. Your line is open.

Hey, everyone. This is Macaulay on for Margaret. Thanks for taking the question. So kind of another one on in terms of the Q4 guidance. Obviously mentioned that 30% plus heading into the quarter and the 28 to 31% guidance today. I'm just wondering if anything has changed or maybe that implies any rate of seasonality and then just what that assumes in terms of the rate of back approvals in Q4 relative to last quarter.

Yeah, well, thank you for the question. Nothing has changed. As you can hear, at the beginning of the year, we talked about our guidance being a billion dollars. So it's come up quite a bit through the year. Last quarter, we gave an accurate assessment of how we thought the second half of the year was going to play out, and nothing has changed from that. If anything, I think you've seen the growth, and we've started to talk a little bit more, I think give you a little bit more specifics around our business from a thrombectomy versus embolization perspective, which gives you a sense, I think, that the strength is coming perhaps even more from the thrombectomy business globally. And then obviously in the United States, it's even stronger. So if anything, I think that's the change in disclosure that shows the strength in the business and the momentum.

Awesome. Very helpful. And then just as a follow-up in terms of the progress on the Thunder trial. So I know I mentioned last quarter kind of the requirement to change the safety endpoint there and adding approximately 75 more patients. Notice that, you know, there were a bit more patients added to the clinical trials website, so just wondering if there were any additional modifications to the trial design there or just maybe if you could speak to Thunderbolt's performance on some of the patients enrolled thus far. Thanks.

It's a great question, and thank you for this. The trial numbers and all were generally in the same ballpark that I was talking to. It's now 275 patients, if I'm not mistaken, and we updated clinicaltrials.gov with the timing, which is generally consistent with what I had expected. And we're on that trial. We're seeing some nice enrollment right now. We're pretty excited about what we're seeing. I will tell you that the most important thing is we're very happy with the performance of the product. And that is obviously the best part of it. But we also have validation separate from that product. As you know, we have lightning bolts and we have done a huge number of cases with that similar technology, different catheter size, and it is, as everyone who's done checks know, performing incredibly well. So, again, we can't wait to bring that to the market. We have to run the trial, and we can only do so much to speed up the enrollment, but so far, so good. And as we've said, we're going to be bringing this technology, the CABT technology, to every part of the body, head to toe, so that we can modernize the thrombus removal and really start taking a huge dent out of the number of patients that are suffering. And so Thunderbolt is going to be a big part of that, and our optimism is as strong as ever.

Great to hear. Thanks again, and congrats on the CORA.

Thank you.

Your next question comes from the line of Bill Plavonic. Your line is open.

Great, thanks. Good evening, and thanks for taking my questions. First up is just, Maggie, can you help me understand, so phenomenal quarter on the operating margin at 12.3%. How should we think about Q4? It sounds like that's going to continue to go up in Q4 and, you know, sequentially as we go into 2024. And then secondly, I don't know if this, you know, especially with gross margin going up, but you also mentioned just on the Salesforce changes. I forget how you phrased it, but basically you're going to make some changes. I wonder if you could give us some granularity on kind of what you're doing and, you know, is that new different Salesforce for different indications? Is that splitting territories? Just anything you're willing to share to help us out on that. Thanks so much.

Okay. Thanks, Bill. Maybe I'll touch on the margin first, and then Adam can talk about address the sales force. I think overall, as I mentioned earlier, the gross margin trend that we see already a few quarter sequential improvement is primarily driven by continued thrombectomy product mix, and we definitely see that trend to continue. I also mentioned overall with continue leveraging our overall capacity. I think this is also the time that we may accelerate some of the investment in our manufacturing area, so gross margins definitely are reaching a stabilized level, but then we will continue to see more margin improvement in 2024. In terms of OPEX leverage and overall operating margin, We continue to leverage a lot of the overhead and infrastructure investment that we put in a couple years ago, and I think we'll continue to see more leverage going forward.

Bill, this is Adam. To follow up on the specific Salesforce question, I want to thank you. I think you all might know I love talking about our amazing sales team and what they've been able to accomplish. It's one of my favorite topics. As I laid out on the call, our team in the field, particularly in vascular now, have so much to do with our embolization business, which is the majority coil business in the market, together with launching two transformative products, together with continuing to get CatRx, our coronary thrombectomy tool out there on this on the basis of the strong cheated study a few years ago. So they're just busy and now we're facing you know, more than like doubling the number of customers we've typically had on our thrombectomy business and getting through all that process. So the point is we are going to evolve that sales force. We are not splitting the sales force. That's not our plan. We are going to evolve it with people who can make some of this work more efficient without fundamentally changing the core structure of the sales team. I'm not going to be too much more specific for competitive reasons. As you know, I don't typically share the number of sales reps and how we think about that because that's not how we've managed our team, and our team has performed so well over the last many, many years. But we can do that. within the context of our growing profitability. And that's the most important part. This isn't going to change that trajectory. And I think it will be a significant evolution of the team, but one that will allow us to do more but not impact that important part of profitability.

Great. Thank you for taking my questions.

Yeah, thank you.

Your next question comes from the line of Michael Sarcone with Jefferies. Your line is open.

Good afternoon. Thanks for taking the question. Just the first one to start, you had mentioned over the next 18 months you plan to launch four new CABT products in the U.S. I was wondering if you can give us, you know, any color there whatsoever or those, you know, new TAMs, new indications. We'd just love to get some more color there.

Yes, it's a great question. I'm very hesitant for, obviously, you know, competitive reasons to give too many specifics. Needless to say, I will say the following, though, and that is this is the beginning, not the end, of what we think we can offer with our CAVT platform. Those four products are going to be significant. tangential or on the sidelines. And that's not the end of it. We alluded to technology that is in development that would be part of and attached to and be integrated into the whole platform. That will continue to move this field forward in making these procedures easier, making both the physicians and the hospitals feel much better about the flow and the treatment of these patients. We're really at the beginning of this next phase, and we'll give you more updates, obviously, as those products get cleared, but again, pretty excited about what the next year looks like. I got to tell you, our R&D team is It's just evolving. They've always been amazing. They've brought us this far, but they're extraordinary. And I need to do a quick shout-out to them for getting us to this stage.

Great. Thank you. And I believe you also disclosed, I think you said, 50% U.S. vascular thrombectomy sales growth year over year. Can you just talk about any kind of competitive response you're seeing And then maybe what was the similar category growth international for your thrombectomy business on the vascular side?

Yeah, I'll start. Clearly, 50% of U.S. growth in thrombectomy is multiples faster than we've seen from anywhere else. Internationally is a much smaller base, so the growth percentages can be higher quarter to quarter. And it was slightly higher than that this quarter, but it is because distributor variance, you had a good quarter, marginally so, and it's a smaller number, so the percentages are bigger. But both regions did well.

Okay. Thank you.

Thank you. Your next question comes from the line of Richard Newiter. Your line is open.

Questions, guys. I think, Adam, you had made a comment about where you are exiting the year with those, you know, with 1,000 VAC committees working their way through the process, and you expect to be through them all in the first half, 24. Can you flesh that out a little bit about what exactly that means? Is there any kind of quantification or directional color we should be thinking about in terms of growth, first half, second half, next year? Just I'm trying to understand, you're pretty thoughtful about those kinds of comments. So I'm just making sure we're hearing the messaging correctly around that.

Yeah, no, I think it's a really appropriate and great question. You know, there's, let me maybe sort of walk through a little bit about what I said, but also sort of what does it mean more specifically. What I said is that there's over 650 of those centers got VAC approval this past quarter, but have not yet ordered because they're going through what we, you know, for lack of a better term, we're calling the typical supply chain process where you work with the supply chain, the hospital to get the product ordered and on the shelf and all that. And so that's going to happen, you know, for the most part, most of those during this quarter, you know, some might drag a touch, but most will happen this quarter. So once you get it ordered, now we don't do large stocking orders, you know, sometimes companies have done that over the years we do very basic you know you order one maybe two and get started and then with that you have success and reorder the product so we make it pretty straightforward so it's not a question of stocking order revenue it's really getting going what I also said there are two other points one is there's another 600 over 600 hospitals that are still in the beginning of that VAC process that haven't yet had that VAC approval. Once that happens, then they move to that second category that we have to get through the supply chain part and get onto the shelf. Once we're there, once we're ordered and able to be used, then our effort switches in those hospitals to not only having it being used in sort of the cases that are obvious. But if you look at, and we track this, you know, billing data at every hospital pretty carefully, how many patients are being treated with mechanical thrombectomy versus how many are still being treated with lytic or open surgery depending on the vascular bed. And that's where the work really starts. And that's what I was talking about, that we're geared up to do that work, not only on the sales team side, but also through our market access work, so that we can bring this technology deeper into the hospital. And so once you get approved, we don't expect you to be at the normalized run rate of using our product right away. We think that will continue to grow for a while. And that's what I was articulating. So this is a journey. This is a process, again, not to diminish the success we've had this quarter, the success we expect to have next quarter or in 24. We're going to have a lot of success and a lot of growth. We're just going to see the work continue to build sort of year over year for quite a while. I guess the best way to say it is as we look at the space that has thrombus in people's bodies, whether it's in the head all the way through the body or in the toe, we are going to continue to be committed to this space. This is our focus. This is our mission. And we are going to continue to develop those markets, to focus on that. And it's going to take some time. But in the short term, we're going to have a lot of success. That's why I laid out those numbers. Those are not insignificant opportunities this quarter and next. But in the long run, I think it's going to be much more significant.

Okay, thank you for that thorough answer. Just lastly, you know, anything with respect to the vascular thrombectomy launches that is going better or worse in line with your expectations, you know, at this point in the launches? Thanks.

Yeah, that's a great question. It's hard to... To answer that question, I'm a tough critic on our own products. But at the same time, I'm also a believer in our technology and the engineers that have developed it. So better or worse, it's hard to necessarily judge. What I will say, and I really bring it back to the things that matter the most to physicians but mostly in patients, is the three things that I highlighted. Safety is first. The product has to be safe. Without that, you know, you run into all kinds of topics and issues and so on. So safety, the safety profile of these products has been extraordinary. And that I think is one of the things that, you know, shows up in our data but also shows up in talking to physicians about it. The second is speed. You know, no one, everyone in interventional business knows The longer you're doing something, the worse it hits. The best thing is it works really quickly and you're done. And the speed profile of these is really unparalleled of anything we've ever done or anything that's ever been on the market. And then the final point is simplicity. It has to just be easy, simple to use. You put the one product in, you don't have multiple things or tools. And that's been something that people have really responded to. So, again, that is sort of our mantra. That's our guide. You know, we want to make it safe. We want to have speed, and we want to have it simple. And having that baseline now with our current CAVT products and knowing that we can even build on that has given us extraordinary confidence but also confidence a lot of energy that the next period of time is going to be really rewarding for us.

And our next question comes from the line of Mike Maxon. Your line is open.

Yeah, thanks. You know, just want to follow up on that question about the 1,200 customer accounts. You know, how many of those were not previously Penumbra customers?

Yeah, that's actually a great question. I can't, with the exact specificity, give you that number. I can tell you that I know that way more than half, the majority of those 650 accounts and the majority of the following 600 are new customers. There might be a handful of of existing customers in there, but the vast majority are new customers.

Okay, thanks. And then, you know, the one thing that surprised us in 23 was just the strength on the neuro side. I mean, you know, clearly Vascular looked like it was going to do well given the product cycle, but, you know, Thunderbolt's been delayed. So what I'm wondering is, you know, looking into next year, Do you have anything new coming in Nuro to kind of, you know, help drive the growth there in 24?

Yeah, I'll start with, you know, we always have new products in both fields, Nuro as well. I'm not going to comment on them. The core technology is right now Red 72 Ascended, which has got a long way to go to continue to drive You know, we're continuing to, you know, just this week I heard of a physician who had tried it who typically hadn't been using our aspiration catheters and was particularly blown away by how well it tracked. So I think we won yet another customer over. So that's going to drive our success for a while because, again, if you can't get the catheter there, then Thunderbolt doesn't. matter. You know, you have to have it be so easy to get there that you're excited to use Thunderbolt. So I think the timing on Thunderbolt really sets us up so that we can use the time next year to really continue to get in to more and more accounts, which, as you said, we have done pretty well this year. We've taken back significant share, as I said in my prepared remarks. We're now in our estimate, over 55% of the stroke aspiration catheter market. It's kind of a notable thing that we're competing with 28 other catheters. Usually, when you have that many products all competing, you don't have a dominant player, if you will. And the fact that we are is a testament to the success we've had this year with RET72 and SendIt, and I don't think that will stop, and I think we'll continue with that.

Yeah, Mike, good question. The only thing I would add, this is Jason, is you saw with SendIt, the U.S. stroke business have another really strong quarter, double-digit growth this quarter, 20%. And as you know, we don't have yet that product launching anywhere outside the U.S., The other thing I would just note is you're hearing us talk about thrombectomy globally, which includes stroke, obviously. It would be thrombectomy head to toe vis-a-vis the embolization and access businesses. So I think what you're going to continue to see is thrombectomy, including stroke, but obviously vascular thrombectomy as well, lead our growth. So just pointing that out as you're asking about neuro versus vascular, I think what we're talking about more is thrombectomy vis-a-vis embolization at access.

OK, got it. Thank you.

Your next question comes from the line of Matthew O'Brien. Your line is open.

Hi, thank you. This is Samantha on for Matt. Just a couple from us. I guess first, On the expected robust growth for thrombectomy, I know you said 40%. How much could you attribute that to maybe an easier pre-flash comp versus expectations for sequential growth?

Yeah, so it's a very good question. Thank you for it. We continue to expect Very good sequential growth as well. The comps aside, we're growing significantly faster regardless than I think folks expected in thrombectomy generally and, of course, relative to the market. That's happening both year over year and sequentially.

Okay, thank you. And also a question about the vax. Thank you for all the details there. We're just wondering if you provide any more detail on maybe how many of those facts are kind of double counted for both flash and bolt versus a single flash or just a single bolt.

Yeah, so that's a really good question, and I apologize for maybe not clarifying. The way we talk about them is each one is a separate account. So it's possible, for example, that in the 650 accounts that I said have gotten back approval but have not yet ordered because they're going through the supply chain process and will soon. Of those, you might have one hospital, but two, I counted twice because it's Bolt and Flash. And sometimes the same physician is using both products. But in other times, they're not because as you know, there's interventional cardiologists, vascular surgeons, and interventional radiologists who share this and some specialize in certain parts of the body and others don't. So many of those that have one hospital but two submissions, it's separate people who are advocating for those products. It's just a different process. So it's not all lumped in as one. That's why we count them separately.

Again, if you'd like to ask a question, press star then the number one on your telephone keypad. Our next question comes from the line of David Rescott. Your line is open.

Hey guys, thanks for taking the questions. I just wanted to start maybe on the neuro thrombectomy segment. I think maybe the, you know, the comps there were a little bit tougher year over year and the numbers came in a little bit below maybe what we were expecting, obviously higher on the peripheral vascular side. But just wondering if there's anything you'd want to call out just on the neuro thrombectomy segment. I know you talked about send it getting into a position of expanding the market, taking share, maybe having a little pricing benefit there. We're just wondering on a cadence basis, you know, year over year, sequentially, you know, if there's any color you can provide there.

Yeah, thanks, David. This is Jason. So our neuro business achieved our expectations for the quarter, and the team really executed quite well, especially in the United States. So in the United States, the Neuro franchise grew 17% year over year. I think we've been articulating from the beginning of the year that we expected our vascular business to grow above our total company guidance range, which of course has come up from a billion dollars to where it is today throughout the year, and we said Neuro would grow below this range. Since we don't give specific guidance by franchise, I think generally models may have not accounted for this guidance, perhaps because the neuro growth was higher in the first half of the year. But we fully anticipated neuro growth internationally in the second half of the year would face more seasonality and lower growth in some distributor markets, which is why we gave the guidance context at the beginning of the year that we did.

we are quite proud of the progress in our neuro business and continue to expect the new products we have with send it and thunderbolt eventually will fuel our future growth okay great um helpful and then maybe just sticking on that point taking a step um you know back longer term i know that you know newer products put you in in the share gain position when we think about just the overall maybe either us or worldwide neural thrombectomy market i know maybe earlier in the year, we saw kind of some of these trials reading out in thrombectomy specifically about, you know, maybe expanding the market towards some of the large core and park-sized patients, more distal occlusions, just wondering from a higher level, you know, more macro perspective, if the neurothrombectomy market itself outside of Penumbra is re-accelerating, re-expanding, or if those are opportunities to drive further growth going forward.

Yeah, this is Adam. I think this is a really important question, so I appreciate you raising it. I think that opportunity, particularly on the trials where they're looking at the core impact, Farkton saying we could treat a lot more of the patients than we thought we could treat, is a really huge development. We haven't called that out yet. specifically because we want to wait and see that that's what behavior is happening in sustainable form before we sort of get too excited about it. But I don't disagree with you. I think from everything I've heard and all the conversations I've had with neurophysicians, that is a real likely possibility. It's relatively new. It's sort of summertime. And so to talk about it as a clear possibility happening trend, you know, it's a touch early. But I think all the conversations have led to believe that that could grow the market. Obviously, so far, you know, given the timing of those, the gains we've seen have been share-based. But yeah, I mean, I would be delighted for patients if we could treat more and more patients and they can get better. And obviously, that would have a very, very positive impact on the neuro part of the thrombectomy business.

Okay, great. Thanks, and congrats on that quarter.

Yeah, thank you. And your next question comes from the line of Shibun Singh. Your line is open.

Great. Thank you so much. Adam, I was hoping you could provide your views on GLP-1 just, you know, related to novel stride clinical data that is studying GLP-1 impact on peripheral artery disease. The primary and study completion date isn't until mid-2024, but we have seen, you know, an impact on stocks in the medtech world just on top line readouts that have come out before. So, just anything you can share with us ahead of it, you know, to instill confidence, you know, in the PID space.

Yeah, thank you for that question. Obviously, it's been a topic. in the investment world, less obviously in the physician community directly. Look, we're a healthcare company. We obviously applaud any innovation of whatever form that can help people be healthier and feel better. That being said, if you look at just the sort of factual statement, you know, obesity, for example, is not a direct causation of thrombus formation. It is a risk factor. There are lots of risk factors, age, and I could list, you know, 20-plus risk factors. It is not, you know, one of the top risk factors even. That being said, you know, if you were to look at that and say, you know, maybe you could have a several percentage point impact in the long, long run in the number of patients that have clot, which I'm not willing to necessarily concede, but if it did happen, it wouldn't be a material question as it relates to our numbers because we're less than 10% penetrated in a market, and then by the time we were experiencing that, you know, it would be many, many years, if not decades, away. The other analogy, and I think for folks who are in stroke or cardiovascular disease of any kind, is really looking at statins. 20 plus years ago, they held out huge promise and obviously they've been very valuable. They've become widely adopted. The use of them varies. commonplace the prices come way, way down to very, very affordable. But it hasn't in any form, you know, it's helped in certain things, but it hasn't changed at all the number of patients who have clot in their body. It just hasn't. And so, notwithstanding the other benefits that it has brought, it hasn't lowered the number of patients with fat in their body at all. So, I think from a, you know, are we going to be necessary as a company and our innovative products continue to be used at the scale where we have ambition around? I think the answer is pretty clear. We will be.

Got it. That's really helpful. And just, you know, as a follow-up, I wanted to get some color on the plus 20% growth that you've called out in 24. Could we think of that as a base case? You know, it's still, you know, we haven't entered 2024. And then, you know, also you're exiting the year at 28 to 31% growth in Q4. So what does that imply for 24 and, you know, the plus 20% being a base case or realistic, just any color there would be helpful. Thank you for taking the questions.

Yeah, look, I don't want anyone to misinterpret what I've said. What I said at the investor conference in September was that 20% plus growth was achievable. And then I reiterated that I strongly believe that today. I also said, you know, please... Give us the courtesy and time, again, not trying to hide anything, not trying to disavow that, but to get through this year and do what we traditionally do is give formal guidance with the exact numbers on our next quarterly call. Again, please don't read into that, that that's somehow anything other than commenting or reiterating what I've already said.

Fair enough. Thank you so much.

Thank you.

Your next question comes from Citigroup. Your line is open.

Thank you very much. It's Joanne Winch. And I apologize if you've addressed this. There's a lot going on. Was there any stocking in the quarter? And can you comment a little bit on what you're seeing in terms of it looks like there is some neuro weakness and how that happened, U.S. versus OUS?

Yeah, well, let me address the stocking. We didn't typically address that earlier, so I'll do it quickly. We don't typically do stocking. Our initial orders are one or two units at the most just to get people started. So that's not part of our business model and hasn't been. Jason can address the neuro question, which Julian was already asked as well.

Yeah, it was, but I'm happy to go through it. So as I mentioned just a little earlier, and apologies to the rest of the people on the call just for going over this again, but our neuro business actually achieved what we expected it to in the quarter. It executed very well. So just to give you a bit more context, the neuro franchise grew 17% year-over-year over And if you remember, we articulated earlier in the year, in fact, at the outset of guidance, that we expected vascular growth writ large to be higher than corporate average growth and neuro would be lower. And we sort of, I think we got some pushback to that after the first half of the year because neuro was stronger. But we understood the cadence of our business. We understood that we were going to see more seasonality and distributor variances in our a neuro business internationally in the second half of the year, which is why we stuck with that. And of course, since we don't guide to specifically to neuro grows this and vascular grows that, I think models just didn't maybe account for that. But in our view, our neuro business and neuro team is doing exceptionally well.

And there are no further questions at this time. Ms. Hamlin-Harris, I turn the call back over to you.

Thank you, operator. On behalf of our management team, thank you all again for joining us today and for your interest in Penumbra. We look forward to updating you on our fourth quarter call.

This concludes today's conference call. You may now disconnect.