Earnings Call Transcript - PEN Q3 2024

Operator, Operator

Good afternoon. My name is Jeremy, and I will be your conference operator today. I would like to welcome everyone to Penumbra's Third Quarter 2024 Conference Call. All lines have been muted to avoid background noise. After the speakers finish their remarks, we will have a question-and-answer session. Thank you. Now, I would like to introduce Ms. Cecilia Furlong, Business Development and Investor Relations for Penumbra. Ms. Furlong, you may now begin your conference.

Cecilia Furlong, Business Development and Investor Relations

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 2024. A copy of the press release and financial tables which includes a GAAP to non-GAAP 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, 2023, filed 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 with 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 need to update or revise our forward-looking statements as a result of new information, future events, developments, or otherwise. On this call, financial results for revenue and gross margin are presented on a GAAP basis, while operating expenses, operating income, and adjusted EBITDA are presented on a non-GAAP basis. The corresponding GAAP measures and a reconciliation of GAAP to non-GAAP financial measures are provided in our posted press release. Non-GAAP operating expenses and operating income exclude expenses related to the wind-down of our Immersive Healthcare business in the third quarter of 2024 of $5 million, a one-time expense associated with the acquisition of IPR&D of $18.2 million in the third quarter of 2023, and amortization of acquired intangible assets of $2.4 million in the third quarter of 2023. Adjusted EBITDA of $56.7 million for the third quarter of 2024 excludes the wind-down expenses, stock compensation expense, depreciation, and amortization provision for income taxes and interest income expenses. Adam Elsesser, Penumbra's Chairman and CEO, will provide a business update. Maggie Yuen, our Chief Financial Officer, will then discuss our financial results for the third quarter of 2024, and Jason Mills, our Executive Vice President of Strategy, will discuss our updated 2024 guidance. With that, I would like to turn the call over to Adam Elsesser.

Adam Elsesser, Chairman and CEO

Thank you, Cecilia. Good afternoon. Thank you for joining Penumbra's third quarter 2024 conference call. In the third quarter, we generated total revenue of $301 million, representing a year-over-year increase of 11.1% on a reported basis and 10.9% on a constant currency basis. Our third-quarter results reflect another strong performance by our U.S. thrombectomy business driven by continued adoption and further market penetration of our current CAVT Portfolio, Lightning Flash 2.0, and Lightning Bolt 7. U.S. Thrombectomy grew 21.2% year-over-year to $162.1 million, with our U.S. VTE franchise delivering revenue growth of 32% year-over-year and 13% sequentially. The balance of our U.S. Thrombectomy franchise continued to perform very well in line with our expectations. In the quarter, we received FDA clearance for two new CAVT products, Lightning Bolt 6X and Lightning Bolt 12, which further enhance and build out an increasingly comprehensive CAVT portfolio. I will provide additional details on these products later in my prepared remarks. In addition, we received CE Mark for Lightning Flash 2.0 and Lightning Bolt 7 in mid-September and are in the early phases of introducing our transformative technology to European markets. The trend of improving profitability continued in the third quarter with gross margins expanding to 66.5%, up 90 basis points over the prior year period and non-GAAP operating income of $40.3 million or 13.4% of revenue in the third quarter, up 110 basis points year-over-year. Behind positive product mix shift and operating efficiencies, we continue to see a path to a gross margin profile of over 70% within the next 18 to 24 months and expect non-GAAP operating margin expansion to outpace gross margin expansion for the foreseeable future. Additionally, backed by strong revenue growth, expanding gross margins, and disciplined operating spend, this quarter we generated $51.3 million in operating cash before you include the impact of our $100 million stock buyback. We are well positioned to continue to increase our profitability and operating cash flow into the future. Within our U.S. Peripheral business, the standout of the quarter was Lightning Flash 2.0. Flash 2.0 consistently removes blood clots in VTE patients considerably faster than all older products. Given the speed of the procedure now with Flash 2.0, there is no significant blood loss. This Flash 2.0 technology compares very favorably to other companies' older technology that takes much longer to remove blood clots with enough blood loss to make physicians feel like they need to return blood to the patients. As a result, Flash 2.0's performance continues to command physician interest, and our third-quarter results reflect strong adoption of our latest Flash technology in its first full quarter on the market, with September representing our highest month of VTE procedure volumes ever as we continue to gain VTE market share. The speed of Flash 2.0 was extremely evident in a PE case this quarter where a firefighter who was 39 weeks pregnant was treated for a very serious PE with Flash 2.0. The speed of the procedure saved the patient and her baby. I had the privilege of watching a video of her and her baby being greeted by a line of firefighters when she was being discharged from the hospital. In addition, we received FDA clearance for Lightning Bolt 12, expanding our portfolio of the latest generation CAVT products engineered to address VTE. Lightning Bolt 12 combines our proprietary modulated aspiration technology validated by Lightning Bolt 7's strong clinical outcomes with a catheter size designed to address smaller parts of the venous anatomy. The initial cases have gone very well, and this technology expands the number of VTE patients we can treat with our CAVT technology. While we expect modest initial contributions in the fourth quarter, looking to 2025 and beyond, we view CAVT's demonstrated value proposition and our increasingly comprehensive VTE focused CAVT catheter portfolio helping accelerate conversion from other mechanical thrombectomy products. Our U.S. arterial business led by Lightning Bolt 7 continued to perform well in the third quarter. FDA clearance of Lightning Bolt 6X in September further expands the reach of our advanced CAVT technology to smaller arteries including below-the-knee arterial occlusions where our legacy catheters are currently used to treat a portion of the patient population. The introduction of Bolt 6X will deliver CAVT's benefits, improved procedure efficiency, and a reduction in procedure times to these patients. Similar to Lightning Bolt 12, we expect modest contributions from 6X in the fourth quarter as we commence commercialization. That said, we see a meaningful opportunity for our arterial focused CAVT portfolio currently including Bolt 7 and Bolt 6X to accelerate physician conversion from open surgery or the use of lytics to a computer-assisted endovascular first approach to treating arterial clots. Despite significant progress to date, we remain in the early stages of helping the over 800,000 patients annually in the U.S. who suffer from VTE and arterial clots with our proprietary CAVT technology. Turning to the neurovascular business, our team delivered another solid double-digit performance in stroke thrombectomy. As interest wanes in the super large bore OE8 catheters as aspiration catheters, most of the companies with those products have switched to positioning them as guide catheters. This positions us very well with our market-leading aspiration portfolio led by RED72 with our proprietary SENDit technology and RED43. As we prepare to bring Thunderbolt and the benefits of our CAVT technology to the neurovascular field. As we previously announced, our Thunder trial recently completed enrollment with follow-up scheduled to be completed by the end of the year. We will provide additional future updates as appropriate, but needless to say, we are excited about the prospect of bringing CAVT and its demonstrated clinical benefits and procedural advantages to the neurovascular field, further solidifying and enhancing our market-leading position in the field of stroke thrombectomy. Shifting to our international business, in September we received CE Mark for Lightning Flash 2.0 and Lightning Bolt 7, further expanding the global reach of our latest CAVT technology. Physician interest in the technology in European markets is high, and while we have commenced initial sales, we expect revenue contributions to scale in a measured fashion given the current reimbursement landscape across the region. That said, over time we see an opportunity for CAVT in international markets, supported by the work we're currently doing in reimbursement, clinical evidence generation, and backed by strong commercial execution. As we look toward 2025 and beyond, we view a significant opportunity for CAVT to globally transform the way blood clots are addressed and treated. Over the near term, we are focusing on executing a four-pronged strategy that we previously laid out. Number one, constant innovation to further enhance CAVT's comprehensive value proposition and further expand the patient population with clot burden able to be treated with CAVT therapy safely, effectively, swiftly, and simply. Number two, clinical and health economic data generation via randomized clinical trials, real-world studies, and our market access initiatives to increase awareness not only of CAVT's outcomes benefits but also of the economic benefits to hospital systems. Number three, investment in our commercial and market access teams to fully realize CAVT's potential and support sustainable, strong growth in the number of patients able to benefit annually from a computer-assisted interventional approach. And number four, executing our strategy with a disciplined focus on driving operating efficiencies and an improving profitability profile. I'll now turn the call over to Maggie to go over our financial results for the third quarter.

Maggie Yuen, Chief Financial Officer

Thank you, Adam. Good afternoon, everyone. Today I will discuss the financial results for the third quarter of 2024. Financial results on this call for revenue and gross margin are on a GAAP basis, while operating expenses and operating income are 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. For the third quarter ended September 30, 2024, our total revenues were $301 million, an increase of 11.1% reported and 10.9% in constant currency compared to the third quarter of 2023. Our geographic mix of sales for the third quarter 2024 was 75.2% U.S. and 24.8% international. Our U.S. region reported growth of 16.2%, driven by 21.2% growth in our thrombectomy franchise. Our international regions decreased by 1.9% reported and 2.5% in constant currency, primarily due to a reduction in China revenue of $13.6 million, which was offset by an increase of $12.2 million in all other international regions. The sequential growth in our total revenues of 0.5% was primarily driven by an increase in our U.S. thrombectomy revenue of $8.3 million, relatively flat revenue in Europe, and offset by a decline in China revenue of $9.4 million. Moving to revenue by products, revenue from our global thrombectomy business grew to $204.1 million in the third quarter of 2024, an increase of 14% reported and 13.8% in constant currency compared to the same period last year. Our U.S. growth of 21.2% is driven primarily by the continuous adoption of CAVT. Our international business declined by 7.1%, primarily driven by a decrease in China revenue, which was offset by an increase in all other international regions as compared to the same period last year. Revenue from the embolization and access business was $96.9 million in the third quarter of 2024, an increase of 5.5% reported and 5.2% in constant currency, which is in line with our expectations and primarily driven by an increase in the U.S. Gross margin for the third quarter of 2024 is 66.5% compared to 65.6% for the third quarter of 2023. We delivered 90 basis points improvements driven by favorable thrombectomy product mix across all regions and strong productivity improvements. Additionally, sequentially we had a 100 basis point improvement in our gross margin excluding the one-time $33 million Immersive Healthcare inventory write-off in the second quarter of 2024, which reflects higher thrombectomy product mix and favorable distributor mix. Our manufacturing team will focus on ramping up our volume while driving our productivity and efficiency for our new product launches in the fourth quarter. Now onto our non-GAAP operating expenses, non-GAAP operating income, and margin and adjusted EBITDA. Total operating expense for the quarter was $160 million or 53.1% of revenue, compared to $144.5 million or 53.3% of revenue for the same quarter last year. Our research and development expenses for Q3 2024 were $22.6 million compared to $21 million for Q3 2023. SG&A expenses for Q3 2024 were $137.4 million or 45.6% of revenue, compared to $123.5 million or 45.6% of revenue for the third quarter of 2023. We recorded operating income of $40.3 million or 13.4% of revenue in the third quarter of 2024 compared to an operating income of $33.2 million or 12.3% of revenue for the same period last year. We wound down our Immersive Healthcare business in the later half of the quarter, resulting in GAAP operating expense savings of approximately $6 million. We expect to create GAAP operating expense savings of approximately $40 million a year moving forward. With the full quarter of Immersive savings, we expect to continue our sequential margin expansion into Q4 2024. We posted adjusted EBITDA of $56.7 million or 18.8% of total revenue compared to $51.5 million or 19% in the third quarter last year. Turning to cash flow and balance sheet, we ended the third quarter with cash, cash equivalents, and marketable security balance of $291 million and no debt, which is a decrease of $48.7 million sequentially due to the stock repurchase of $100 million during Q3 2024. Excluding the stock repurchase, our operating cash increased by $51.3 million driven by operational profitability and improvement in working capital management. We continue to expect positive operating cash flow trends for the rest of 2024 and beyond.

Jason Mills, Executive Vice President of Strategy

Thank you, Maggie, and good afternoon, everyone. We reiterate our total revenue guidance range for 2024 of $1,180.0 million to $1,200.0 million, with one quarter remaining in the year. We are comfortable with expectations at the middle of this range, which is where they were coming into this call. Furthermore, we are raising the lower end of our 2024 guidance range for U.S. thrombectomy growth to 24% to 25% from 23% to 25% previously. Moving down the income statement, we expect gross margin in the fourth quarter to be consistent with third quarter levels. And we expect non-GAAP operating margin to expand sequentially. Excluding the impact from the Immersive Healthcare impairments these metrics would correlate with our full-year guidance of 100 to 150 basis points improvement in gross margin and 100 to 200 basis points improvement in operating margin.

Operator, Operator

All right, your first question comes from Richard Newitter from Truist Securities. Please go ahead.

Richard Newitter, Analyst

Hi. Thanks for taking the questions. Maybe just to start off on the U.S. thrombectomy, it was a healthy 22%. I think you said that your U.S. venous or VTE was 32%. Maybe could you just go over the U.S. neurothrombectomy piece? By my calculation, and it might be wrong, but it would suggest a pretty big deceleration in the third quarter. Is that right? And how should we think about the trend there and going forward?

Adam Elsesser, Chairman and CEO

Yes, thanks for the question. I appreciate it. Our stroke business had a really good sort of high double-digit growth. So I don't think I would qualify that as a deceleration. If you remember the elements that go into U.S. thrombectomy, we have neuro, we have arterial, peripheral arterial, coronary as well as VTE, and obviously coronary, which has been out there with our legacy products for many years is in the single digits. So I think that's the delta. But Neuro did really well this quarter.

Richard Newitter, Analyst

Okay, sorry, that's my math so I apologize there. Congrats. That's a very solid U.S. Neuro growth rate. I guess maybe just on the international piece and the China. What does this do to your view of recovery for those regions? And as we look forward into 2025, it seems like the international business continues to be somewhat unpredictable. So what's your visibility there and how do we think about new product contribution in some of the areas that you're just launching in with the new products to offset that? Thank you.

Adam Elsesser, Chairman and CEO

Yes, I think it's a great question. Look, we've talked about China last quarter and sort of what's happening for us particularly as we go from our licensing revenue model to the distribution model. That's part of our deal. We spent a lot of time last quarter walking through that. So really nothing has changed that just now showing up. So we've sort of taken that into account. There's no new information there. Obviously, as China recovers, that will be an upside in the future, whether that's the back half of 2025 or 2026 or beyond. There's certainly significantly fewer headwinds in 2025 than there were in 2024 internationally. And there are some real bright spots with, as we called out on this call, the launch of Flash 2.0 as well as Lightning Bolt 7. Obviously, there's a lot of interest. There's a lot of conversations between physicians here in the States that are using it to their colleagues in European markets. And I think as we roll that out, we're going to see that part of the business do really, really well. So there's not a lot of new news on our international markets. This is playing out how we had talked about it for a while.

Richard Newitter, Analyst

Okay, thank you very much.

Adam Elsesser, Chairman and CEO

Thank you.

Operator, Operator

Our next question comes from the line of Robby Marcus from JPMorgan. Please go ahead.

Robert Marcus, Analyst

Oh great. Thanks for taking the questions and congrats on a nice quarter here. Two from me. First wanted to ask on the margin expansion. It once again came in nice, saw some upside there, especially on EPS. How should we think about your ability to continue to drive this margin expansion? Is it one of these things that 100 to 200 basis points is a good range to use so long as thrombectomy continues to grow at the elevated levels? Or is there something one-time in 2024?

Adam Elsesser, Chairman and CEO

Yes, if you're talking about gross margin. That is a longer-term process that we've laid out for a while now, which is it's combination of efficiencies together with the product shift as we move toward a bigger chunk of that business coming from our cavity platform. So that will continue. If you're talking about operating margin again, that also we think will outpace the gross margin. And I think this is the quarter that has shown that we have a really profitable business here and we can do both things. We can obviously invest in this, as we laid out again sort of clearly the four-pronged strategy where we can invest in innovation. We'll invest in the clinical data in a variety of fashions as well as in the growth of our commercial and market access teams. All of those investments focused on growth at the same time doing that in a very, very profitable business. So I think we were pretty clear in the prepared remarks about that that hasn't changed from the past, it's just clearer than ever now. And I think this quarter puts a pretty fine point on that.

Robert Marcus, Analyst

I was thinking operating margin. So you got both of them. I appreciate that. And then just be sure I covered it all for you. I appreciate it. And then just came back from TCT today and we saw yesterday the peerless data from your competitor. And I guess the question is, do you think that's going to be viewed by the clinical community as specific to your competitor or do you think that's going to be applied to thrombectomy in general and translate to your business as well?

Adam Elsesser, Chairman and CEO

Yes, look, without being inappropriate, given the pretty muted reaction that we've seen and heard from most physicians, we certainly hope that it's not viewed as a negative for all products. Obviously, some of the details there were not surprising given the procedure, the duration of the procedure with their older devices and really the bleeding rates that aren't true now with Flash 2.0. So I think Flash, CAVT and 2.0 are commanding a lot of attention and I think from everyone we've talked to there on the ground as well as those who are reading that, I think we're all looking past that particular type of study and to the more important comparison, which is against anticoagulation like we're running in our storm study. And I think that's where the real energy is put in the field and that's where the interest is. So, I guess given those issues we weren't surprised with somewhat of the muted reaction, but I don't think it's a negative for us at all.

Robert Marcus, Analyst

Appreciate it. Thank you.

Operator, Operator

Our next question comes to the line of Larry Biegelsen from Wells Fargo. Please go ahead.

Unidentified Analyst, Analyst

Hi, it's Lay calling in for Larry. Thanks for taking my questions. Just starting with the Thunder trial, congratulations on completing the patient enrollment. We saw on ClinicalTrials.gov that the sample size, the patient sample size has changed. It's a little bit less than what you started with. And the endpoint has changed. One of the safety endpoints has changed. Can you just comment on those and if the FDA agreed to those changes? And I have a follow-up.

Adam Elsesser, Chairman and CEO

Yes, the FDA did agree to those changes. That is accurate.

Unidentified Analyst, Analyst

For both of those changes?

Adam Elsesser, Chairman and CEO

Yes.

Unidentified Analyst, Analyst

Okay, perfect. Thank you. And then, Adam, you've mentioned a few times before and again on this call that there are fewer headwinds in 2025 versus 2024. Can you just elaborate on which headwinds would go away in 2025 versus 2024 and what additional tailwinds that we can see in 2025? Thank you.

Adam Elsesser, Chairman and CEO

Yes, that's a good question. So some of the things we've talked about this year, at the beginning of the year, we talked about recalibrating selling some of our embolization products and our access products in certain markets internationally where the reimbursement had gone down to the point where it wasn't a viable business. That's obviously one significant issue that will not be prevalent in 2025. We've talked a bit about China over the last couple of calls and recalibrating that as we move to the next phase. And so, and also the delay, if you will, in getting CAVT in Europe. So those are sort of the big topics that we were dealing with internationally. And those really go away in, for the most part in 2025. Some of the things that are looking positive, obviously we've also talked about new product launches that are coming. We have this sort of continued share gain with existing products like what we just saw pretty significant share shift just again in yet another quarter with Flash 2.0. So pretty consistent movement there. I think when you add those up we're looking forward to 2025 as well.

Operator, Operator

Our next question comes from the line of Joanne Wuensch from Citi. Please go ahead.

Joanne Wuensch, Analyst

Thank you very much. I actually have two quick questions up in front. Can you walk us through your steps to get to your 80% gross margin goals over the next 18 months? How much of that is coming from real or the renamed label for that or something else? And then my second question has to do with Thunderbolt. Congratulations on that, on that completion of the clinical trial and the filing. But I'm curious about the steps to commercialization and how you think about uptake. Thank you.

Adam Elsesser, Chairman and CEO

Yes, good questions. I may have misheard you. I think you asked about gross margins and I think you said getting them to 88% as opposed to what we had set out there, which was 70%. So I just want to make sure I heard it right. I might not have, but gross margins we think can get to above 70%. And the biggest, the big issue there is continued efficiencies. But the primary driver is just as we go further and deeper into CAVT products, the margins are different and the product shift drives that. So that's the primary driver getting to the gross margin number that we talked about or above that. On Thunderbolt, you talked about sort of the, the question was related to commercialization. Let's, before we get ahead of ourselves, let's do the follow-up for that that's due. We should complete that by the end of this year and then obviously we'll submit it and go through that. We certainly know how to launch products after 20 years, and we certainly are pretty excited about it. But let's wait till we can get the trial formally finished with the follow-up and move on, and then we'll give you more updated information at that point.

Joanne Wuensch, Analyst

Thank you. Sorry if I set your goals too high.

Adam Elsesser, Chairman and CEO

Well, it's a good internal goal. No, I'm just joking.

Operator, Operator

All right, our next question comes from the line of Michael Sarcone from Jefferies. Please go ahead.

Michael Sarcone, Analyst

Hey, good afternoon. Thanks for taking the questions. Just first one for me, really nice growth in U.S. VTE. Could you maybe talk to us about where you think your share is shaking out across both CE?

Adam Elsesser, Chairman and CEO

I think it's a bit early to provide exact numbers. We might revisit this at the end of the year, similar to last year, to realign our figures. Throughout this year, we’ve observed a shift in market share toward us. While it’s not the right time to pin down specific figures, we’ll consider doing so as the year concludes. The progress in the PE segment has been notable. We've successfully shared the DVT business equally, but the transformation in PE has been significant, largely due to the advancements with our Flash 2.0 product. It offers remarkable speed, resulting in significantly shorter procedures with minimal blood loss. This reduces patient anxiety regarding blood loss and the need for transfusions with other products. Being able to remove clots more quickly without complications is beneficial for the patient. This capability allows for rapid stabilization of patients, which I believe is very promising for our future. It emphasizes the ongoing necessity for innovation in our field, as products continuously improve. I hope everyone shares in the excitement of this progress, which has been a hallmark of our company for the past two decades.

Michael Sarcone, Analyst

Got it. That's helpful, Adam. And just my follow-up, Bolt 6X and Bolt 12 just got FDA clearance. You have to go through VAC processes for each account to start selling those. Can you just talk about that process? And then maybe anything on pricing and what it does for economics on the P&L?

Adam Elsesser, Chairman and CEO

Yes. Well, a couple of things just first on price. Obviously, the CAVT products have a little bit different price point than the non-CAVT products do. So there in a comparison to legacy products, which are literally just the catheter and the original pump, there is obviously going to be a difference. In terms of the process, yes, I am not aware of a blanket free pass and not having to go through the process with new products. These are obviously new products we'll go through that process. And again, having launched multiple products every year for many, many years now, I think we know how to do it, and we'll keep going. But they do have to go through the VAC process.

Michael Sarcone, Analyst

All right.

Adam Elsesser, Chairman and CEO

Yes, thank you.

Operator, Operator

Our next question comes from the line of Samantha Kurtz from Piper Sandler. Please go ahead.

Samantha Kurtz, Analyst

Hi, this is Samantha filling in for Matt today. Thank you for the opportunity to ask questions. We would like to know more about the 6x and the new 12 devices. Specifically, could you explain the differences between the below-the-knee catheter and APR 1? Is it just the size of the catheter that varies? Additionally, could you discuss the competitive dynamics in the arterial market?

Adam Elsesser, Chairman and CEO

Yes. The catheter is indeed smaller. The data shows that a smaller size allows it to reach further distal locations, not just below the knee but also into smaller arteries in other areas of the body, as I mentioned earlier. This reflects the natural evolution of CAVT as we expand its use. The "X" in the 6X functions similarly to our SENDit tool in the neuro space, which assists in guiding the catheter to more distal areas. This enhances the ease of tracking. Overall, the product is designed to navigate further into the vasculature to effectively remove clots. Your second question was about the 12 devices; could you please repeat that?

Samantha Kurtz, Analyst

Well, just competitive dynamics going on in the arterial market.

Adam Elsesser, Chairman and CEO

In arterial. I'm sorry, I apologize. I think everyone knows there's not a lot of competition. There are a lot of companies with sort of gizmos and various things. I think we've seen this play out in stroke in the brain for years. This game sort of happened for many years in stroke. Aspiration works. Aspiration, the whole science behind aspiration is pretty clear, I think folks have understood that now in the neuro space. And I think that's working, and people are starting to pretty clearly understand that in the arterial space on the vascular side. So there's not a lot of companies that are focusing on that. And certainly, none of them have the modulated aspiration that we bring with Lightning Bolt 7 and Lightning Bolt 6X, which is really a whole total game changer. It sort of creates a new class, if you will, of technology. So really, the fight for us, the competition, if you will, is open surgery and anti-coagulation and also analytics. All of that is where we put our energy, and that's where our focus has been, and that's what's really seen the continued growth of that business sort of quarter-over-quarter.

Samantha Kurtz, Analyst

Great. And then just one more quick one. I know we touched on the vendor trial a couple of times in the call from a different point. When would follow-up ending at the end of the year, when could we expect to see data for that trial?

Adam Elsesser, Chairman and CEO

I made a mistake a few years ago by providing timelines for the trial's completion, so I'm not going to set a specific time this time around. As soon as we have a clear answer, we will share it. We’re looking forward to getting that information out. We'll provide updates on the timeframe once we have more details about completing the trial.

Samantha Kurtz, Analyst

Thank you.

Adam Elsesser, Chairman and CEO

Thank you.

Operator, Operator

Our next question comes from the line of Matthew Brian from Piper Sandler. Please go ahead.

Samantha Kurtz, Analyst

Hi, this is Samantha filling in for Matt today. Thank you for taking the questions. We want to inquire more about the 6X and the new 12 devices. Starting with the Six, can you explain the difference between the below-the-knee catheter and APR 1? Is it just the size of the catheter that's different? Also, could you discuss the current competitive dynamics in the arterial market?

Adam Elsesser, Chairman and CEO

Yes. There is a difference in the size of the catheter; it is obviously a little smaller. The data show that a smaller catheter can reach further distal areas, not just below the knee but also into smaller arteries in other parts of the body, as I mentioned earlier. This represents the natural evolution of CAVT as we expand its application. The "X" in 6X refers to a tool similar to SENDit in the neuro space, which assists in navigating the catheter to more distal locations. It's really about easier tracking. Overall, you understand the product's benefits; it can access deeper into the vasculature to effectively remove clots. Your second question was about the 12 devices, correct? What was the second part of that question?

Samantha Kurtz, Analyst

Well, just competitive dynamics going on in the arterial market.

Adam Elsesser, Chairman and CEO

Samantha Kurtz, Analyst

Great. And then just 1 more quick one. I know we touched on the vendor trial a couple of times in the call from a different point. When would follow-up ending at the end of the year, when could we expect to see data for that trial?

Adam Elsesser, Chairman and CEO

I'm not going to specify a timeline for the trial's completion, as I made a mistake a few years ago by providing specific end dates. Once we have a clear answer, we will announce it. We are eager to share that information, but we will provide updates on the timeframe when we have more details about concluding the trial.

Samantha Kurtz, Analyst

Thank you.

Adam Elsesser, Chairman and CEO

Thank you.

Operator, Operator

Our final question comes from the line of Mike Matson from Needham. Please go ahead.

Michael Matson, Analyst

Yes, thank you. Just a couple on Thunderbolt. So on the THUNDER trial, do you think we'll see the data at some point maybe in the first half of next year before you submit it to the FDA? And then just pricing on Thunderbolt, I know you're not going to tell us what it is, but is it going to be at a similar sort of premium to what we've seen with what the venous side?

Adam Elsesser, Chairman and CEO

Yes, those are good questions. We haven't yet determined the precise timing for when the data will be published and presented. Typically, this occurs around major neuro meetings. However, our focus is on completing the trial first, after which we can provide updates on specific timing. I hope you understand that. I'm really looking forward to finishing this process. Regarding pricing, within the reimbursement framework for neuro procedures, we will ensure that it is profitable for hospitals, but there will likely be a premium. I cannot guarantee that it will match another CAVT product dollar-for-dollar, as each is somewhat different depending on the reimbursement structure of their respective vascular systems.

Michael Matson, Analyst

Okay, great. Thank you.

Adam Elsesser, Chairman and CEO

Thank you.

Operator, Operator

There are no further questions at this time. Ms. Furlong, I turn the call back over to you.

Cecilia Furlong, Business Development and Investor Relations

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.

Operator, Operator

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