Q2 2025 Penumbra Inc Earnings Call
Ladies and gentlemen, good afternoon. My name is Abby. And I'll be your conference operator today.
Alliance have been placed on mute to prevent any background noise.
If you would like to ask a question during that time, simply press star followed by the number 1 on your telephone keypad.
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Thank you. I would like to introduce Miss Cecilia Furlong, Business Development and Investor Relations for Penumbra. You may begin your conference.
Thank you, operator, and thank you all for joining us on today's call to discuss the earnings release for the second quarter of 2025.
A copy of the press release and financial tables, which include a GAAP to non-GAAP reconciliation, can be viewed under the Investors tab on our company website at www.pink.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 forward-looking statements due to certain risks and uncertainties, including those referenced in our 10-K for the year ended December 31, 2024, 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, for a more complete discussion of these factors and other risks that may affect our future results or the market price of our stock.
The company disclaims any duties 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 amortization of acquired intangible assets of $2.4 million, impairment of our immersive healthcare business of $76.9 million in the second quarter of 2024, and adjusted EBITDA. Excluded are impairment expenses, stock compensation expense, depreciation, and amortization, as well as provision for income taxes and interest income expenses.
Items, Chairman and CEO Adam Elsesser will provide a business update. Maggie Yuen, our Chief Financial Officer, will then discuss our financial results for the second quarter of 2025, and Jason Mills, our Executive Vice President of Strategy, will discuss our updated 2025 guidance. With that, I would like to turn the call over to Adam Elsesser.
Thank you Cecilia, good afternoon.
Thank you for joining Penumbra's Q2 2025 conference call. In the second quarter, we generated total revenue of $339.5 million, representing underlying year-over-year growth of 13.4% on a reported basis and 12.7% on a constant currency basis. Our second quarter performance reflected extraordinary ongoing execution by our commercial team against our strategy, together with our focus on continuous innovation, clinical and health economic data generation, along with the work physicians are doing to further expand the total number of patients treated globally with our novel technologies.
Our US thrombectomy business led overall growth in the quarter, with results reflecting strong continued adoption and ramping utilization of our CABT portfolio.
National business delivered solid growth ahead of expectations.
Second quarter U.S. thrombectomy revenue increased 22.6% year-over-year to $188.5 million, led by 42% year-over-year growth in our U.S. VTE franchise, as the clinical benefits of FLASH 2.0 and BOLT 12 continue to support and drive further market penetration and competitive conversions.
Below the top line, gross margin of 66% was in line with our prior announced expectation. As we executed on our planned accelerated Ruby Excel inventory build.
We began shipments of Excel at the end of the second quarter and entered the third quarter. We're well-positioned from an inventory standpoint to meet the strong interest in Excel we've seen in the field to date.
We remain on track and are well positioned to achieve a gross margin profile of over 70% by the end of 2026, and we expect operating margin expansion to outpace gross margin expansion for the foreseeable future as we prioritize.
Delivering profitable growth and an expanding profitability profile.
Turning to our U.S. peripheral business, our second quarter thrombectomy performance reflected the competitive strength and clinical benefits of our comprehensive, current CVD portfolio.
Spanning Flash 2.0, Bolt 6X, Bolt 7, and B 12 alongside. Purposeful and focused execution by our commercial team.
We treated more VTE patients in the quarter than in any prior periods supported by our teams. Relentless focus and prioritization on improving patient outcomes, driving conversions from anti-coagulation Lytx and other mechanical thrombectomy platforms to CABT in both PE and DVT.
In arterial, the clinical benefits of our modulated aspiration technology in Bolt 7 and Bolt 6X continue to support and drive physician conversions from open surgery or the use of Lytx to CABT.
Based on our consistent success and our clear view of the opportunity ahead in peripheral thrombectomy.
We strategically invested in the buildout of a separate peripheral embolization Salesforce to provide heightened focus in thrombectomy and emulation.
We have added over 50 emulation sales reps and over 40 vascular clinical specialists.
With these new hires in place, we will be able to have a team solely focused on our thrombectomy business.
As well as a separate team focused on launching Ruby Excel and driving long-term growth in our emulation business.
Adding to the information we provided on our last earnings call, Ruby XL is a larger, softer, and longer coil than other commercially available coils. It allows us to now participate quite effectively in about 20% of the current market that we have not been able to in the past.
With the early performance of Ruby XL, we expect to see ramping benefits from our investment. In our commercial team, through the back half of the year and beyond, with our thrombectomy team, we are well-positioned to focus exclusively on continuing to address the significant unmet need in the treatment of clot burden throughout the body. Our new embo team is able to focus on providing our comprehensive Coral.
Portfolio 2, Physicians and hospitals.
As our team drives adoption of our technology on a day-to-day and account-by-account basis,
We are simultaneously focused on positioning CVT for long-term growth while enhancing our competitive position.
Advancing the field through technology innovation and high-quality clinical data generation is our priority.
During the quarter, we completed enrollment in Storm PE, our prospective multi-center randomized controlled trial evaluating CVT plus anticoagulation versus anticoagulation alone for the treatment of acute.
Intermediate high-risk PE.
To provide level 1 evidence to help inform PE treatment and impact standard of care.
Enrollment in Storm, PE completed ahead of schedule.
And we look forward to presenting the results from the trial at a major medical conference this fall.
On the arterial side. We recently announced the launch of our stride 2, clinical study, our initial stride study, when she'd corporate Incorporated, primarily older, generation technology, demonstrated compelling results, including a 98.2% 30-day, limb, salvage rate,
With stride 2, we intend to both expand the patient's sample size and broaden the geographic enrollment base in comparison to stride 1, with stride 2 focused on demonstrating the benefits of our latest generation CVT technology. Looking forward, we will continue to invest in high-quality clinical studies.
In tandem with our market access initiatives to highlight the significant benefits and value proposition of our differentiation, differentiated current and forthcoming products.
Shifting to our neurovascular business.
Our US stroke thrombi franchise delivered another solid performance, growing ahead of the underlying stroke market in its first full quarter on the market. The Red 72 silver label, with its enhanced trackability, continued to generate strong physician interest and saw ramping adoption and utilization.
Regarding Thunderbolt, we are currently in an active process with the FDA and will provide additional updates as soon as possible.
We remain very excited to introduce Thunderbolt to the neurovascular field.
At SNIS earlier this month, there was a great deal of discussion about distal occlusions in stroke.
We heard many physicians confirm that our Red 43 aspiration catheter is the preferred device to treat patients with distal occlusions.
There is a lot of discussion among physicians about embolizing your artery, or MMA as it is commonly known, and the unique properties of our Swift coil that allow for the safest treatment modality.
It is estimated that there are more patients who could be treated in this category than in traditional cerebral aneurysms.
We are focused on investing in further innovation across our diversified neuro portfolio, spanning aspiration, access, and ambition.
In summary.
Our second quarter results reflect solid execution by our team, as we continue to deliver long-term growth in multiple underpenetrated markets.
We are committed to continuing to transform patient care across these markets, and we are excited to introduce new innovative products in the months and years ahead.
I'll now turn the call over to Maggie to cover our financial results for the second quarter of 2025.
Thank you, Adam. Good afternoon, everyone. Today, I will discuss the financial results for the second quarter of 2025.
Financial results on this call for revenue and gross margin on the GAAP basis. While operating expenses, operating income, and adjusted EBITDA are on a non-GAAP basis. The corresponding GAAP measures and our reconciliation of GAAP to non-GAAP financial measures are provided in our post and press release.
For the second quarter ending June 30th, 2025, our total revenues were $339.5 million, an increase of 13.4% reported and 12.7% in constant currency compared to the second quarter of 2024.
Our geographic mix of sales for the second quarter of 2025 was 76.8% U.S. and 23.2% international.
Our us region reported growth of 19.5% driven by 22.6% growth in our from back Tomy franchise compared to the same period last year.
As we anticipated, our international regions decreased by 3.2% reported and 5.8% in constant currency, primarily due to a decrease in China revenue compared to the same period last year, which was partially offset by an increase in all other international regions.
As we look at head, for the second half of 2025, we expect headwinds in China to ease resulting, in a return to growth across all of our International regions.
% was driven by both an increase in global thrombectomy and embolization, and excess revenue across all regions compared to the first quarter of 2025.
Moving to revenue byproducts.
Revenue from our global thrombectomy business grew to $230.3 million in the second quarter of 2025, an increase of 13.1% reported and 12.6% in constant currency compared to the same period last year. This growth was primarily driven by our U.S. thrombectomy business, which saw an increase of 22.6%.
Our International from back to me business increased by 16.2% in line with expectations, primarily due to a decline in China revenue. Excluding the impact to the China region, our Internationals from back to me revenue grew by 14.4% when compared to the same period last year.
Revenue from our ambulation and access business was 109.2 million in the second quarter of 2025.
An increase of 13.9% reported and 12.8% in constant currency, primarily driven by an increase in U.S. embolization sales, underscoring the launch of our new Excel products.
Gross margin for the second quarter of 2025 is 66% compared to 54.4% for the second quarter of 2024, which includes a one-time $33.4 million immersive Healthcare inventory write-off.
Excluding this one-time write-off, the gross margin.
Slightly increased year-over-year, as expected, our gross margin slightly decreased sequentially, due to investment in the launch of our Excel product and the higher international mix of growth across all regions.
As we move to the second half of 2025, we expect to see sequential margin expansion from favorable product mix and productivity improvements.
In addition, we are on track to achieve our full-year gross margin targets. However, as our separate thrombectomy and embolization teams start ramping, we might see some month-to-month variability in product mix.
Importantly, we remain well positioned to deliver our long-term growth margin profile of 70% by the end of 2026.
And now onto our non-GAAP operating expenses, non-GAAP operating income and margin, and adjusted EBITDA.
Total operating expense for the quarter was $183.2 million, or 54% of revenue, compared to $164.5 million, or 54.9% of revenue for the same quarter last year.
Our research and development expenses for Q2 2025 were 23.2 million or 6.8% of Revenue compared to 24.9 million or 8.3% of revenue, for Q2 202024, which reflects Savings of 5.2 million due to our immersive business wind down. Offset by continued investment in product development.
Sgna expenses for Q2 20225 were 160 million or 47.2% of our revenue for Q2 20225 compared to 139.6 million or 46.6% of revenue for Q2 2024.
To support the momentum in demand and ensure we are positioned to capitalize on long-term growth drivers, we made targeted hires in our commercial and market access teams.
Sequentially, our expense increased by 6.5 million which as Eda mentioned was primarily due to a deliberate front-loaded investment in our emulations sales team and additional vascular clinical specialists.
With a favorable hiring market to attract top-tier talent, we acted to bring in a high-impact commercial team, which we expect will contribute to our results in the quarters ahead.
We recorded operating income of 40.8 million or 12% of Revenue compared to an operating loss of 1.6 million for the same period last year.
Which includes 1 time, $333.4 million in immersive healthcare inventory write-offs.
Excluding this one-time write-off, our operating profit increased by $9.1 million. We posted adjusted EBITDA of $61.4 million, or 18.1% of total revenue, compared to $13 million, or 4.3%, in the second quarter last year.
$424.6 million and no debt, which is an increase of $45.7 million, sequentially driven by strong operating profitability.
We expect positive operating cash flow trends to continue in 2025 and beyond.
And now I'd like to turn the call over to Jason to discuss our updated 2025 guidance.
Thank you, Maggie, and good afternoon, everyone. Due to outperformance in the second quarter, we are increasing our guidance for total revenue to a range of $1,355 million to $1,370 million, which represents 13% to 15% year-over-year growth.
We maintain our guidance for U.S. thrombectomy growth of 20% to 21% compared to 2024 levels. We also maintain our guidance for both gross margin and operating margin for the full year 2025.
This concludes our prepared remarks, operator. We can now open the call to questions.
Thank you. At this time, I would like to remind everyone that in order to ask a question, press star and then the number 1 on your telephone keypad. We will pause for just a moment to compile the Q&A roster.
And our first question comes from the line of Larry Biegelsen with Wells Fargo. Your line is open.
Uh good afternoon. Thanks for taking the question and and congrats on a nice quarter here Adam. Um I wanted to start with storm PE and then uh Esco Thunderbolt question so it's good that we're going to see the storm PE data this fall. Um, Adam. It's it's a relatively small study and we've seen you know many uh PE trials with rvlv uh ratio as the primary point. So why is this study important? And what impact could it have if positive and I had 1 follow up?
Yeah, no, it's it's a great question. As you know, um Larry, it's the first randomized study, um, completed that we're aware of, in the world comparing anti-coagulation and mechanical thrombectomy to anti-coagulation alone. So we've seen lots of single arm studies and other things. It's the first randomized study that has that comparison which is the question that everyone wants answered. So for that reason alone, it's significant. The size of the study is a testament to the confidence in the product. Obviously the larger the study, the more room, you know, you have to have let you know a difference, you have a 100 patients, it's a lot smaller um number of patients, to show that difference. So,
It it actually is a testament to um, to I think the confidence in the study that being said, um, I think the you're aware we put together a international umly, very renowned group of Physicians, uh, to create on the steering committee of this trial. They were the ones who came up with the endpoints and the size of the study, and the powering of it all. Um, and, and really, and these are just not interventionalists. These are non-interventional in the field of treating PE. So, um, I think it's, uh, again, we'll wait to see the results. Um, but I think it could have a significant impact. Um, uh, and and again that the design of the study is a testament to um, the work of some of the the the world's experts.
That's helpful. And then on Thunderbolt Adam, any update on how we should think about the FDA review time. I think, in the past, if I'm not mistaken, you've pointed to precedents that, you know, had about a 6-month review time. And lastly, some investors Adam, I think have construed. Some of your recent comments that your enthusiasm for Thunder has changed. Um, could you address those items please? Thanks sure. Um, yeah, I don't remember. Um, saying, 6 months for a clinical study, um, uh, the, you know, product review times vary, depending on the company. Um, that being said, I can tell you the following. Um, uh, you know, we worked with the FDA, uh, for many, many years. This,
The neuro division, um, I can tell you that they are thorough, um, which is something that I'm extremely supportive of. These are obviously products going up into people's brains, and I'm, um, very supportive of that process. Um, the process is what we expected, um, with the FDA, and, uh, to be honest, um, I've heard the rumors that I'm somehow not excited. I
Huge positive impact for many, many people for many, many years to come.
All right, thanks so much.
Thank you.
And our next question comes from the line of Travis Steed with Bank of America. Your line is open.
Hey, thanks for taking the question. I guess the the first question that I'll go with the Salesforce split, you know why? Now is the right time and how you're thinking about the uh, kind of any near-term, disruption from that and the kind of the margin question and there was a comment uh kind of made on the the mix on margins.
Um, yes, so the well the margin um, the comment I made about margins in my talk was we had said on the last quarter that we were accelerating the bills of Ruby Excel. So there'd be a 1 time. 1 quarter impact to do that, which we saw a minor impact. Um, that doesn't go beyond this quarter. Um, and I think we reiterated, um, very clearly that, um, uh, we are on track for our 70 plus percent, uh, at the end of 2026 that being said, it is worth noting that, um, the Ruby Excel is, um, their margin given the nature of that coil and the price point is actually accretive to our margin. Um, uh, and so that's a positive for us. Um, uh, why now um, for the the, the, the, the split here. Um, it it is.
Is essential given the success that we're having, um, in, uh, um, uh, in the thrombectomy side on that business. Um, and our view of where that's, you know, continued growth will come. It's pretty, um, pretty extraordinary opportunity that we really need to have people be able to focus. Um, they can't, you know, they're selling right now on the thrombectomy side alone into the arterial. Um, DBT p, e coronary. Um, and then to add a whole bunch of different types of emulation. Procedures was a lot for our reps to do, um, and to do it, well, across all of their customers. So this just makes sense to do it by Focus. Um, I think we have been lucky to be able to attract, literally some of the best talent, um, there is in the field, um, and I think it will prove to be great for Arthur business because that focus and to be honest, um, it will
...allow our, um, our peripheral coil business, our ambulation business, um, to continue, uh, to be successful and probably accelerate growth, um, given the launch of the product and, um, the focus that that team has. So it makes sense all around.
Thank you. And the kind of the second question is on the U.S. Timed back to me business, the 20% to 24% guide. You kind of did 24% in the first half, which kind of implies 18% in the second half. I know the slope stroke market's a little bit, I don't know if that's kind of the main reason there, or if there's anything else you'd call out for the second half of the U.S. timed business.
Yeah, no. I I I think it's fairly obvious. Um, you know, that we're pretty excited about our Toronto Community business going forward. Um, obviously we raised our overall guide, you know, um, uh, the quarter before we raised our us thrombectomy guide. Um, and I and I think we're just to be honest. Trying not to get ahead of ourselves, uh, in spite of our enthusiasm right now,
All right, great. Thank you. Congrats on the good quarter.
Thank you.
And our next question comes from the line of Robbie Marcus with JP Morgan. Your line is open.
Oh great. Uh, thanks for taking the questions. Um, I wanted to ask about margins and if there's any way you could quantify the impact of the additional Salesforce buildup here. Um, you know, gross and operating margins came in below the street, just trying to refigure out if it's sad or if it's maybe tied to the outside US EMBO and other um, outperformance. Maybe there was some stocking there or something like that. Thanks.
In Q4, at the same time, um, in terms of operating margin, I think um investing in our commercial team has been a strategic investment for the year. Um, it's just for the right timing and right opportunity we accelerated some of the investment in Q2. Um, but at the same time, overall we are still maintaining our full year margin guidance, so no material impact to the out quarters. Thank you.
Great. Maybe a a quick follow-up.
You know, now that we don't really have a lot of details, uh, reporting now that your competitor has been acquired.
As I'm thinking about us thrown back to me, I was wondering if you could just give us a quick State of the Union of what you think sort of the end market growth rates are in stroke and the different areas in peripheral. So I'm looking at us, time back to me, reiterating the guide, which implies a deceleration in the back half of the year. I'm just trying to figure out what's your weighted average market growth in the U.S., time back to me, relative to the pin number growth rate implied. Thanks a lot. Yeah. Um, it's a fair question. It's, as you know, hard to get accurate market information, particularly when we're the only ones sort of talking about our numbers. You know, you can't really triangulate them with other people's real numbers. So you're getting these sort of...
Partial data sets and trying to triangulate it. So I don't I don't want to over rely on those kind of uh sources because they've proven not always to be accurate as everyone knows. Let me. I'll share sort of the best, I can sort of how we're going. Obviously, our VTE growth, um, is leading the way. Um, third quarter in a row of over 40%. Um, obviously the market isn't growing at 40%, um, it's growing, you know, somewhere around 20%, give or take, uh, is our best guess. Um, so again, we're continuing to take share their the arterial business again, it's, it's less about a market growth there because you're really treating all those patients but mostly with open surgery analytic. So it's moving, you know, those patients from 1, modal to us, um, that had another very strong quarter. You know, we grew, um, uh, similar to what we've done in the past couple of quarters. Um, the market growth in neuro,
um, you know, I won't, you know, I'll be honest was a little soft, um, but we continue to grow, well, above that number as best we can tell, um, uh, because of the setup, um, with red 72 would send it the, the silver label version. Um, and, and frankly, it puts us in a really, really good position. Um, I've always said that we want to try to move Physicians to that product in anticipation of the Thunderbolt launch. Um, and I think,
I think it's given us that opportunity to really do that. Um, and having growing above the market shows that the shares shifting and the setup for Thunderbolt is great. And and then obviously, you know, you know, our coronary business is a much more mature business, um, and it's obviously not growing at those same levels.
Very helpful. Appreciate it. Adam, thanks. Yeah, of course.
And our next question comes from the line of Richard newer with truist. Your line is open.
Hi, great. Thanks for um, taking the questions. Congrats on the quarter. I wanted to go back to the, um, kind of some of the the the sales force initiatives you have going on here. Um, Adam, you had, you know in late 23. I believe, you know, you you you identified the need for an expanded field organization with so many different call points kind of coming in. And, and that was kind of more feed on the street. And here, you're you're taking a little bit of a different approach. Uh, you know, splitting the, the sales organization, you gave the rationale and an answer to your prior question, I'm just curious. How do we think about the impact of the business and the time that will take to get the return on that investment or the payoff, you know, before, OnePlus 1 equals 2? Um,
you know, and if you can compare and contrast kind of, you know, this initiative versus the prior 1,
Yeah, I I it's a it's a fair question. Um, the good news is um,
They are should be focusing on um what they should be focusing on obviously. Um, we're still 1 team, you know, overall and they they're sharing managers. So there's going to be some capacity to help each other out and do all that, which I think is really important, um, for the long-term success. But their incentives are aligned, um, to focus on the parts of their business that they, they're assigned to. Uh, and I think we're going to be in really good shape. I think a lot of the heavy work is done. Um, uh, and has been in play, you know, moving in that position for the last number of months.
So I think we're in pretty good shape. It's, it's a, it's a, it's a great idea. I mean, the team suggests came up with it. I'm thrilled their execution on, it has been really extraordinary, um, and, you know, you always have a little bit of stuff going on, but I think all of that,
Very minor and just behind us.
Got it and, and then, just maybe a follow-up. So, I appreciate you don't want to get ahead of yourself. Um, you know, the first half is clearly coming in a little bit better than expected, you know, uh, on on us Venus, uh, uh, and then also on emulation and the, the implied D cell that's in your guide. Maybe maybe that reflects some conservatism, but assuming all Trends were to hold,
More or less. Uh, is there any 1 division that you, you anticipate a Slowdown or or you're seeing something in the underlying Market? I'm just trying to get a sense for within our us arterial, or us neuros thrombectomy or even. Um, coronary like, is there any? Is there any like anticipated, slowdown or Trend? That's beginning to emerge that you're seeing.
um,
No, I, I think I sort of laid out, you know, the, the 2 areas that that have, you know, a little bit, softer growth if you will, um, obviously stroke as a market, you know, I think if you look at all the data that people, you know, can buy out there, it shows that it really didn't grow a lot, um, uh, in in the last months or so. Um, but we continue to take share, um, I think that, you know, that is
great for us, you know, I think that will continue, um, particularly as, you know, the, the market digests sort of what the right size product is, and how that all works, um, and sort of that,
Setup, and sort of getting ready for Thunderbolt continue. So, I think that puts us in an okay shape predicting that time of all that. You know, you got to give us a little leeway to, you know, we don't control that, and we need to sort of be a part of that. And again, the coronary business is a great business; we treat a lot of patients. Um,
But it's a much more mature business, you know, with, you know, sort of analog technology, which is great in coronary. Um, but but that's obviously not growing. Um, at that level, so there's nothing other than that. Um, and and us just being, um, obviously, you know, uh, the we we have, you know, we still have fresh memories of, you know, in having our enthusiasm, get the better of us and we're not going to, we're going to try not to do that.
Yep. No, uh, I'm not criticizing. That's the right thing to do. Okay, take, thank you. Okay, thank you.
And our next question comes from the line of Bill tonic with canaccord. Your line is open.
Great thanks. Uh, thanks for taking my questions. Um, just first off, you know, it looks like it was really the international and embo access that kind of drove some upside in the quarter kind of eighteen verse at least our expectations and I think consensus but I'm just wondering if there's any sea change you saw there or you know some of these markets coming back sooner than you expected and then maybe even specifically on China. I think there was some commentary there. I know, you know, you had zero and expectations for this year. Is that how that's coming in or is that starting to come back on board and then I have 1 follow-up.
Know, and the Bold products are in those markets now and starting to launch. So we're starting to see the benefits of all that work. Um, and that's really what you're seeing right now. Um and uh, you know I it's great to see it come to together. Um but again, what ultimately will continue to drive it is is you know um the the US thrombectomy business but but now a little bit with some of the the ambulation business because I think we've got a a good run ahead um with that Ruby XL product, which is I'll be honest with you. Yeah. Some of the
Great compliments are coming from physicians who are using that, and really seeing just extraordinary things that they can do for their patients. So it's very gratifying. I think we're set up.
In China contribution in the quarter Maggie. Oh um I'm sorry you did ask that question. I apologize. I should I I didn't write that question down. So um when there was a lifting of the or pausing of the tariffs or whatever we call it, I'm trying to did ask for a small order, it was not particularly material but we did fill it.
Okay, thanks. And then now my follow-up, just it. It, you know, I understand and appreciate kind of the process with the FDA on Thunderbolt. I'm just, you know, you've submitted your your, you know, you ran your trial, you've submitted your filing, you're going through the process, um, I think your commentary was nothing surprising, you know? It it, you know, at this point you should
Be getting towards the end of that. Is there any more like data or studies, or anything else you need to provide or is this just answering basic questions and labeling as we think about the process to get the product uh cleared from the FDA on the market?
I I 100% appreciate and respect the question. Um I think there's only, you know, I'm only going to get in trouble if I answer that because it's going to be a nuanced thing that I I'm it's going to be misunderstood um, and I don't want that to be done. Let me stick with what, you know, I said, which is we're going through the process. It's what we expected and we can't wait to launch this product.
All right, great. Thanks, Adam. Thanks.
All right. Thank you.
And our next question.
Hey everyone. Uh, thanks for taking the question and congrats on the quarter. Uh, Adam coming out of snis. I think there was a little discussion about, potentially being able to reinvigorate some of these, uh, efforts or or kind of like refocus the neuro community on to getting these patients into the stroke centers and prioritizing them back to me. Uh appreciate we might be early in that but as we're moving past Co and this might become a little bit more of a focus. Now in the stroke markets, uh maybe the growth has been a little bit, um, damp. And how do you think about what pin number can do? How do you think about what the industry is doing? Is there a point where, uh, in
In the near future, where we can start to react the growth of the stroke Market.
Yeah, Brandon I think it's, it's a really important question and 1, that I actually think a lot about since, uh, we've been here for many, many years.
Trying to make sure that that happens. Um, I I there is no question. There are some, you know, and frankly a decent number of some just extraordinary um uh, centers hospitals, Physicians leaders, who are doing that work, in their communities, to make sure that everyone that can be treated should be treated is getting treated. Um, and that, that is the most heartening thing when we see that. Um, unfortunately, it's not at every town at every community, at every hospital. Um, and, um, I, I, I don't know how fast the centers that aren't doing that, you know, will sort of get on board. Um, I can't predict that, um, but it, but it is still happening and, and, and it's exciting to see that, um, I think, um, you know, like anything, you know, that has been sort of the, um, the big challenge with with the neuro business. Um, the stroke
Um, I don't want to get ahead of ourselves. We'll wait till that's approved and, uh, we'll see what happens. But I, I'm optimistic.
Okay.
Maybe as a follow up on the embo side of the business, you know, now that you're building out a sales force, there's some, um, uh, some new products like Ruby Excel and maybe Swift pack in the MMA emulation. I'm kind of curious if you would, categorize this as maybe a little bit of a turning point for HBO, is this in, in the sense of the, can this be kind of a materially even better part of the business once these, uh, this separate kind of sales force builds out. It seems like you're viewing a big opportunity there. Please rein me in. If I'm I'm getting ahead of my own skis here. But uh, clearly you're seeing something and is this something in a year from now we're going to be looking back and saying, this is why pin number invested so much into this segment. Thanks.
Yes.
That's what I hope.
And our next question comes from the line of Ryan Zimmerman with btig. Your line is open.
Thank you. Can you hear me? Okay.
Yes.
Thank you. All right. Congrats on the order. Um, not to stir the pot here, Adam, I just want to understand, um, can you just confirm that? Could we see clearance of Thunderbolt ahead of a possible data presentation at Svan in November, is that, um,
Within the realm of possibilities.
Um, yeah, I again, I totally appreciate the question. I don't think you're storing the pot at all. Um, I, I, I don't mean to answer the question the way I've answered the last two or three times, but we're in an active process. Obviously, I don't control it. Um, we're going through that process, and it's what we expected. And as soon as we can, we will tell you something. Um, I, I can't say more than that. I think it's pretty obvious. So, but, okay, I have a lot of respect for, um, the various attempts to get me to say something else.
Stick just 2 more uh around neurovascular 1. You know, I was also at snis, you know, we we saw the distal trials, early in February in February at ISC. Do, do you think you need to do a distal aspiration trial? Cuz clearly all 3 of those trials were with Stan retrievers. And, you know, we saw a subgroup analysis on aspiration in M2 and, you know, clearly it was effective. So, you know, is is a distal trial necessary to kind of reinvigorate that market.
And the second part of the question is, um, just what do you consider successful in the Thunderbolt trial? Because, you know, if revascularization immediate revascularization is the end point, you know, I guess, what do you consider kind of a good time, reduction that we should be looking for in that trial? Thanks for taking my question.
Yeah, both really, really good questions. Um, let's start on the distal one. Um, you know, there's a lot of discussion in SNIS, just sort of prompted. It, you know, we hosted a, um, a symposium dinner, symposium.
Hugely intended, probably 1 of our biggest attended ones we've ever had at snis. So there's a lot of interest in this topic of of distal, um, and there's not an easy answer. Um, there's not a lot of consensus, um, I think people would not mind having a data that, you know, is directly supportive of, um, uh, our our red 43 catheter doing this which is really considered this sort of catheter of choice to do these cases. Um what does that trial look like? You know who would randomize for people who already believe in it? No 1 is going to want to randomize um those patients because they already believe it. Um, so I think it's a tricky trial but there's a lot of conversations that are happening. Um, we're proving to most of them um, about what is next and and what should be done here and and
How fast the clock can come out that the not the case itself time, but the the clot removal time. Um, so that's what we want to measure. Obviously, we have all the traditional endpoints that the trials have. Um, but that's the thing that um, Physicians are going to be looking for, does that change and that there's no standard for people. But if you talk to, as many Physicians, as I talked to, um, everyone kind of has their own gut feel of what their average time is, you know, not their best time, which they share with most people but their actual average time. Um, when you look at, you know, hundreds of cases, um, and and that's what I think will be Measuring Up Against
thank you.
Thank you. Yeah, thank you.
And our next question.
Cerrone with Jeffrey's, your line is open.
Good afternoon and thanks for taking the question. Um, you did a few things going on here, you know you have the sales force ramping, you're ramping Ruby Excel and and you also mentioned, you're moving pads from China. Headwinds do you think maybe just in the, in the context of, of guidance? Can you talk about how you're thinking about seasonality, um, and quarterly Cadence through the back half of the year?
um, you know, obviously there's
traditionally been um a sequential gain from, you know, unless there's some un, you know, unusual thing like product launches or something um that changed that between you know user build a little in the third quarter and ramp into the fourth quarter. So that is, you know, the the fourth quarter is always the best. Unless again, that's something changes because the product launches um, uh, and so, so I expect that to be somewhat the same here now. Yeah, and that's just been that way forever.
Okay, great. And, um, the second question is just, you know, on the U.S. VTE business, really strong growth the past three quarters. You mentioned, you know, obviously the market's not growing at that level. Do you think maybe you can just give us an update on where you stand on the market share front in pulmonary embolism and DVT?
you know, um, I
We we we all try to guess based on all the, you know, data sources that that everyone gets. Um, I think it's, um, it's always sort of a, a Fool's errand to put an exact number on it. Um, we have obviously continued to gain. Share both in, um, in DVT and PE. I think we've made, uh, enough to movement in in DVT to be, you know, over 50%. Um, and I think we've made
A pretty significant dent in the PE business. Um, I'm pretty excited about the cases. We've seen the excitement around that, um, from new users. Um, and I think, you know, if, if a storm PE is positive, you know, that will simply, uh, continue if not, um, uh, accelerate so, um, I think we're in pretty good shape. Again, it comes down to the product. It it is, it is a product that just does what it's supposed to do, simpler and faster and safer than other Technologies. And at the end of the day, I think I've always said, you know, almost all doctors will ultimately use the best product and I think that's just what we're seeing right now. That the proprietary sort of, you know, computer, um, assisted vacuum the back of your CVT is is just a unique animal. That isn't really something that anyone else can do and copy because of, obviously IP, and we're in pretty good shape with it. And we're not done. We're, we're going to keep making
Making it better, and I think everyone knows that.
Great. Thanks. Adam.
Thank you.
And our next question comes from the line of Joanne winch with City. Your line is open.
A PE cases a patient's um, to determine what the best treatment for these patients are. Um, and again, this is the first trial in the world that has finished that compares anti-coagulation to anti-coagulation and, um, a mechanical device in this case, our specific mechanical device. So I think that's what is driving the excitement. Um, because that's the standard of care versus something new. Um, and I think if, if the trial is positive, um, it will obviously have some significant impact on the thinking, around the pa, the Physicians who um, are charged with caring for these patients and, and their referral patterns and what they want to do with these patients and again, to remind everyone, we're you know, we're 10 plus percent penetrated this Market just in the US. So there's a lot more patients that can benefit. And again, if the trial is positive and choke,
Shows that, um, I think it will have some significant impact. Um, again, on a market that, you know, is, you know, all in bigger, you know, than our stroke market. Um, so it's a huge impact and a huge win for potentially lots of patients. Again, assuming the trial is positive.
Thank you.
Thank you.
And our next question comes from the line of Matthew O'Brien with Piper Sandler, your line is open.
Hi. This is Samantha on for Matt. Thank you so much for taking our question. Um, I guess we'd like to continue that train of thought with storm pee and and, you know, we assuming the date is positive and and we definitely think it will be, you know, how do you anticipate the market evolving? You know, is it appropriate to think of it like, stroke where you saw this almost immediate increase in drawn back to me usage after the readout
Um, yeah, we don't know. Um, so let's wait until we get the data and present it this fall, which isn't that far away. Um, that being said, um, the one thing that I want to point out that is different about stroke, um, and this is somewhat important, um, with stroke you have had and still have.
What I alluded to earlier is fundamental.
Structural problem in that, the patients aren't always going to a hospital that does you know, it stroke intervention treatment. So sometimes they have to be moved, are they always moved? That is a structural impediment. You don't really have that in PE um you know, I there's got to be, you know, some Hospital 1, you know, place here, or there.
Or maybe that's true, but the vast vast majority of places where a patient will show up with a PE they could be treated, if that is becoming the standard of care. So it's a very, very different Dynamic and it's something that um, having, you know, spent the better part of ten years sort of working on, I'm incredibly excited to to not have that impediment, um, and be able to just do the right thing for all these patients.
Again, assuming it's possible.
Right. Yeah, thank you so much for that. It makes a lot of sense. And then just we've had 1 follow up on the neurovascular electronic market and specifically, I guess, kind of what the um, the medium vessel occlusion I guess portion of the market is doing, you know, I guess. Can you talk a little bit about your exposure? Maybe what percent of your your stroke business happens in these medium vessel occlusions. Um and
What revenue, if any, is impacted?
Yeah, it it's um, that's a really, really good question. It's hard to pinpoint. That. Exactly because, you know, if you take, um, the medium if you as you call it, uh, our catheters that would typically be used, there are a red 62 and sometimes a red 43, both catheters that are also used in in other places. So it's hard for us to know and pinpoint that, you know, with the kind of numeric
Market didn't grow as much and could that have had some small impact on that number potentially, but but we don't know that with the, you know, a definitively.
Okay, that's helpful. Thank you. I appreciate it.
Yeah, thank you.
And our final question comes from the line of Chris Pasquali with Nephron. Your line is open. Thanks, I wanted to circle back to international embo just given how much that segment drove the upside this quarter and really deviated from the recent trend, both sequentially and year-over-year. First, Adam, if you wouldn't mind, could you quantify the China contributions just so we can tell the extent to which that order might have driven the beat? And then second, I think your original guidance for the year called for international embo to be about flat, for the U.S. to be up maybe mid to high single digits. Both pieces are running ahead of that midway through. So how are you thinking about the full-year growth for that business?
Yeah, let me, well, let me first of all, I'm trying to they they don't order any of our coils. So are, is has nothing to do with our embo number at all as it relates to the larger. Um, uh, you know, um, the larger thing, I mean, they have some access products, they have some, um, uh, stroke, you know, products and thrombectomy products rather as it relates to the larger international business. I, I think, you know, that we have been in a rebuilding mode, you know, for a year and a half.
I, I think we've been pretty open about that process as we want to sort of get the right products there we want to be at a margin that is is Affordable. Um, in markets that do that, and I think what we're seeing is the benefit of a lot of that work. Um, and, um, I'm pretty excited to see that work, you know, it's easy to focus on our us business where there's so much good happening there. Um, uh, but it's also really important that we don't forget about the rest of the business and I'm excited that we can do all of it at once. Um, and and I, I, I think, you know, again, none of this is linear, but I think we're in pretty good shape for a while. Um, as we move into, you know,
not just this year but in part, you know, future years, um, both in our us but but also internationally,
Great. Thank you.
Thank you.
And ladies and gentlemen, that concludes our question-and-answer session.
At that time, I would like to turn the call back over to Miss Furlong for closing remarks.
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 third quarter call
and this concludes today's call and we thank you for your participation, you may now disconnect
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