Penumbra - Q2 2023
August 1, 2023
Transcript
Operator (participant)
Good afternoon. My name is Brent, and I will be your conference operator today. At this time, I would like to welcome everyone to Penumbra's Second 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, again, press star one. Thank you. I would like to introduce Ms. Jee Hamlyn-Harris, Investor Relations for Penumbra. Ms. Hamlyn-Harris, you may begin your conference.
Jee Hamlyn-Harris (Investor Relations Officer)
Thank you, operator, and thank you all for joining us on today's call to discuss Penumbra's earnings release for the second quarter of 2023. 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, 2022, 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 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 GAAP measures and a reconciliation of GAAP to non-GAAP financial measures are provided in our posted press release. 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 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.
Adam Elsesser (Chairman and CEO)
Thank you, Jee. Good afternoon. Thank you for joining Penumbra's second quarter 2023 conference call. Our total revenues for the second quarter were $261.5 million, a year-over-year increase of 25.5% as reported and on a constant currency basis. Our revenue growth in the United States accelerated to 32% year-over-year, our fastest in half a decade, excluding the COVID-impacted second quarter of 2020. U.S. growth was driven by our thrombectomy products in both vascular and neuro, as total U.S. thrombectomy revenue increased more than 40% year-over-year. U.S. vascular thrombectomy revenue accelerated to 50% year-over-year growth, and U.S. neurothrombectomy grew 20% year-over-year, the fastest growth in our U.S. stroke business in five years.
We expanded gross margins in the second quarter, consistent with our expectations, and we expect to make more progress in the second half of the year. We also increased our operating profitability in the second quarter. Non-GAAP operating income was $20.3 million, representing 7.8% of revenue in the second quarter. We grew our operating cash balance by $22 million sequentially as well. Looking forward, we expect to deliver strong revenue growth, gross margin expansion, and increasing profitability and cash flow over the foreseeable future. Penumbra had a very successful quarter, and we are still in the early stages of the journey to bring our proprietary thrombectomy technologies to patients in the United States and around the world.
Our momentum is being driven by the extraordinary outcomes we are seeing in patients treated with Lightning Flash, Lightning Bolt 7, and RED 72 with SENDit technology in the early days of launch for each of these products. Starting with Lightning Flash, we doubled the number of venous thrombectomy cases employing Flash in the second quarter compared to the first quarter, and we grew our total venous case volume double digits sequentially, coming off a very strong Q1. We had another extraordinary quarter with Lightning Flash, and we have many more new customers just learning about and starting to try Flash in the next several quarters. Lightning Flash's transformative power, speed, safety, and efficacy profile is the biggest driver of the exceptional early adoption of the product.
The other important factor resonating with physicians is our straightforward pricing, which adheres to the same simple value-sharing pricing philosophy to which we've been committed throughout our history. Moving to Lightning Bolt 7, our U.S. arterial revenue grew double digits sequentially, representing the fastest growth in this franchise since the launch of Lightning 7 in early 2021. We saw acceleration of Lightning Bolt 7 cases in the last two months of the quarter as conversions from surgery, lytics, and other mechanical thrombectomy products gained momentum. That said, we are even earlier in the launch process for Lightning Bolt 7 than we were with Lightning Flash this time last quarter. As many prospective customers have waited to allow some time to pass before starting the VAC process for Bolt after engaging in the same process for Lightning Flash last quarter.
Consequently, we think adoption of Lightning Bolt 7 will build momentum as we move through this quarter and into the fourth quarter of 2023 and the first quarter of 2024. Taken together, Lightning Flash and Lightning Bolt 7 have generated more pending hospital customers than during any other launch in our history. We currently have well over 1,000 active submissions in hospitals for approval of either Lightning Flash or Lightning Bolt 7. In order to be under submission for approval, a specific physician or group of physicians must champion bringing the product into the hospitals. Importantly, the majority of these physicians represent new customers to our thrombectomy products. Even further, we expect many additional hospital submissions over the next few quarters. Historically, once the submission process starts at a hospital, we have been extremely successful in getting our products through these approval processes.
We are just getting started with Lightning Flash and Lightning Bolt 7. Our commercial team's execution of our strategy for Lightning Flash and Lightning Bolt 7 is incredible. We have a clear strategy to reach the majority of the 800,000 annual venous and arterial patients in the United States over the next five plus years, and we are convinced computer-aided thrombectomy is the way forward. Our neuro business also had a strong quarter. I saw firsthand this momentum at the Society of NeuroInterventional Surgery conference yesterday in San Diego. The outstanding early results we are seeing with RED 72, with the inner catheter SENDit technology, foreshadow an exciting period for our stroke franchise.
This early feedback suggests SENDit could prove to be the most important technology ever launched, addressing the most challenging part of stroke intervention: safe, fast, and repeatable trackability around the ophthalmic artery to the face of the clot. We believe RED 72 with SENDit represents the premium aspiration catheter and is as differentiated in innovation for the front end of a stroke intervention as Thunderbolt could be for clot removal once the catheter is tracked to the face of the clot. We have seen positive share shift with this technology for the last two quarters and expect even more meaningful share shift in stroke in the quarters ahead, leading to dominant share of the U.S. stroke market over the next three to four quarters.
Launching RED 72 with SENDit means we don't have to wait for Thunderbolt to see real share gain and market growth in stroke, and this technology only furthers our enthusiasm and confidence in Thunderbolt once it is cleared. Internationally, we are seeing early success with the launch of our first-generation computer-aided products in Europe, and we have plans to expand access to our most advanced thrombectomy products to our International vascular teams over the next few years. In addition, our international teams and partners also see enormous potential to further expand our leadership in stroke intervention outside the U.S. with SENDit and Thunderbolt over the coming years. Turning to immersive healthcare, I am excited about the additional progress we've made during the quarter working with the Department of Veterans Affairs and key private healthcare partners.
We're hitting important milestones together as we monitor the clinical success of our VR platform across myriad applications in physical rehabilitation, mental and cognitive health. Before I turn the call over to Maggie, I want to say that we recognize expectations for our business are high. In fact, we have very high expectations for ourselves. We have a lot of confidence in our ability to succeed in the near term while we navigate agitated competitive reactions. We also believe in expediting the inevitable, and so we are laying the foundation to help all patients who can benefit from our thrombectomy products. Our current year guidance is a guidepost to near-term success, but it's just the first year within the next five-plus-year journey.
We are paying a lot of attention to the guideposts to success over this longer period, and I believe the visibility we have to the larger patient opportunity is clearer to us now than it has ever been, owing to the feedback we're getting on Lightning Flash, Lightning Bolt 7, and RED 72 SENDit. That visibility gives us increasing confidence that we will continue to deliver strong revenue growth, gross margin expansion, and significant profitability and cash flow over the foreseeable future. I'll now turn the call over to Maggie to go over our financial results for the second quarter of 2023.
Maggie Yuen (CFO)
Thank you, Adam. Good afternoon, everyone. Today, I will discuss the financial results for the second quarter of 2023. 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 second quarter ended June 30, 2023, our total revenues were $261.5 million, an increase of 25.5% reported and 25.5% in constant currency compared to the second quarter of 2022. Our geographic mix of sales in the quarter was 71.4% U.S. and 28.6% International.
U.S. reported growth of 32% and our International regions increased 11.7% reported and 11.6% in constant currency. The sequential growth of 8.3% was primarily driven by continued momentum in our U.S. vascular thrombectomy business, as well as growth in neuro thrombectomy business across all regions. Moving to revenue by franchise. Revenue from our vascular business grew to $152.7 million in Q2 2023, an increase of 23.6% reported and 23.7% in constant currency compared to the same period last year, driven by 50% year-over-year growth in U.S. thrombectomy and a relatively flat year-over-year for the rest of our Global vascular business.
Revenue from our neuro business was $108.8 million in the second quarter of 2023, an increase of 28.3% reported and 28.1% in constant currency compared to the same period a year ago, driven by new products in the U.S., Europe, and Asia Pacific. Gross margin for the second quarter of 2023 is 63.8%, compared to 64.3% for the second quarter of 2022 and 62.6% last quarter. The sequential improvement is in line with our expectations, driven by higher thrombectomy mix and ramping up new product launches productivity, offsetting inflation headwinds.
As our second quarter growth margin still reflects some lagging start-up costs from the prior quarter, our operation team continues to execute well to support the increasing demand, and we expect further growth margin expansion in the second half of 2023. On to our non-GAAP operating expenses, which exclude the amortization of acquired intangible assets of $2.4 million, $1.8 million, and $2.4 million for this quarter, for the same quarter last year and last quarter, respectively. Total operating expense for the quarter was $146.6 million, or 56.1% of revenue, compared to $132.4 million, or 63.5% of revenue for the same quarter last year, and $140.7 million, or 58.3% of revenue last quarter.
Our research and development expenses for Q2 2023 were $21.5 million, compared to $19.6 million for Q2 2022, and $20 million for last quarter. SG&A expenses for Q2 2023 were $125.1 million, or 47.8% of revenue, compared to $112.8 million, or 54.2% of revenue for Q2 2022, and $120.7 million, or 50% of revenue last quarter. We recorded operating income of $20.3 million, or 7.8% of revenue in the second quarter of 2023, compared to operating income of $1.6 million for the same period last year, and operating income of $10.4 million, or 4.3% of revenue last quarter.
While we continue to invest in long-term growth and effectively allocate resources and investment to support new product launches, I'm very pleased with our team's great execution and expect our operating margin expansion trend to continue in the second half of 2023 and beyond. Turning to our cash flow and balance sheet. We ended the second quarter with a cash, cash equivalents, and marketable securities balance of $221.1 million and no debt, which is an increase of $22 million from the last quarter. The sequential increase in cash is driven by an increase in profitability and improvements in working capital terms. Now I'd like to turn the call over to Jason to discuss our guidance.
Jason Mills (EVP of Strategy)
Thank you, Maggie, and good afternoon, everyone. We increase our 2023 revenue guidance to a range of $1.05 billion-$1.07 billion, which represents 24%-26% growth over 2022 total revenue. We continue to expect growth in our global vascular business to be slightly above this range and growth in our global neuro business to be below this range for the full year 2023. From a quarterly perspective, we expect growth in the United States to accelerate modestly from the record 32% growth we posted in the second quarter, while we expect our international growth to be mid-single digits in the third quarter due to seasonality and a challenging year-over-year comparison, and re-accelerate to double-digit growth in the fourth quarter.
In sum, we expect our global revenue to grow in the range of 23%-25% in the third quarter on a year-over-year basis, accelerating to 30%+ growth in the fourth quarter. Moving down the income statement, we expect both gross margins and non-GAAP operating margins to expand further as we move through the second half of 2023. We continue to target over 70% gross margins within a few years.... and over 10% operating margins by the end of 2023, with further expansion expected in subsequent years. I will now turn the call back to Adam for closing remarks.
Adam Elsesser (Chairman and CEO)
Thank you, Jason, Maggie, and Jee. I know I speak for the entire Penumbra team when I say that we are at a defining moment in our company's history. A moment almost 20 years in the making, where we can see clearly now how our innovation with computer-aided thrombectomy can help almost everyone with blood clots in their arteries and veins. We fully understand how much work we have to do going forward. We have studied and learned from the best companies before us, who have taken on market development and done it the right way. I can promise the following: myself, our entire Penumbra team, the physicians we will work with, and the hospital systems are ready to take on this challenge. We are going to keep on trying till we reach our highest ground.
The next five-plus years will be hard work, but the most exciting part of the Penumbra journey. Thank you. Operator, we can now open the call to questions for the next 40 minutes.
Operator (participant)
At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We'll pause for a moment to compile our Q&A roster. Your first question is from the line of Bill Plovanic with Canaccord Genuity. Your line is open.
Bill Plovanic (Managing Director and Equity Research Medical Technology Analyst)
Great, thanks. Good evening. It's an impressive quarter. I'm, I'm trying to figure out where to start. I think, you know, in the, in the U.S. Neuro, can you help us understand? I mean, I, it, it sounds like the, the, you know, the RED 72 with SENDit is really surprising even, even you internally. Just kind of what's really going on there in terms of that adoption, then an update on the Thunderbolt. Do you expect to have that trial enrolled by the end of the year? Is that kind of still on track or, you know, to get that out end of the year then launch it in 2024?
Adam Elsesser (Chairman and CEO)
Yeah, great questions, Bill. Thank you. Yeah, the good news, I won't say that RED 72 with SENDit is surprising us. We've been in neuro for a long, long time, so we know it pretty well. It is obviously very heartening for us. As you know, we have spent the better part of 20 years tackling this issue, the idea of trying to navigate catheters of the right size up to the intracranial circulation and up to M1 and beyond, when necessary. We've had some great products. We've had some struggles, obviously, a few years ago.
To have a product now that can track better than anything we've launched, even than the, the old faded Xtra Flex, is, is really exciting for the team and heartening, and frankly, the physicians have embraced it, because if you can't get there, you know, Thunderbolt doesn't matter. You know, you, you have to be able to get there in a routine way, and that's a, a critical part of the procedure. I'm glad you asked about the Thunderbolt. You know, let me give you a, a little bit of an update. As I've mentioned in the past, the timeline for that has been pushed out a touch. There are two reasons.
The first is, and we've mentioned this, that the first sort of roughly 100 patients enrolled took a little longer to enroll due to the required eight-hour window. We have seen enrollment accelerate now as the trial has progressed. That's a really good sign. The second reason, the FDA asked us to modify the safety endpoint from all serious adverse events at 24 hours to symptomatic ICH at 24 hours. This request and change has not stopped enrollment in any way. It does increase the sample size a little by about 75 patients.
This request was not related to anything specific to our trial or device, it, but seems to be made in order to make our trial consistent with other stroke trials that are currently being run, and to our knowledge, those trials have also been pushed out, for potentially similar reasons. We're finalizing the details with the FDA, and as soon as all that's done, we'll formally update this, but it might add another 12 months or so. That said, that allows us the time to really penetrate the market with 72 with SENDit, which, again, we don't have to wait, for Thunderbolt to do that, and we have the opportunity to take significant share, but equally importantly or as importantly, grow the market with this premium product. I think it's set up, for a really, good run.
You didn't ask this question, Bill, but I know you will have it as your first follow-up, so I'll, if you don't mind, take the liberty of answering it first. And that is, this slightly new timing does not impact our projected numbers at all for 2023, 2024 or 2025. I wanted to make sure that I preempted the question.
Bill Plovanic (Managing Director and Equity Research Medical Technology Analyst)
Oh, good. Yeah, well, you preempted half the question. As you think of 2023 guidance in the raise, it reflects the quarter, not much more. I'm kind of wondering, how do we think about, you know, the... What are you including in the, in the bottom end of the range and the top end of the range, given the outperformance in the quarter? It, at least to our numbers, it doesn't seem like you're adding much in for the back half of the year. Thanks for taking my questions.
Jason Mills (EVP of Strategy)
Yeah, thank you, Bill, for the question. It's a good question. The first thing I'd say is that in our first two calls so far this year, we've raised our revenue guidance by about $60 million. I think that's about 3x the amount our results exceeded consensus expectations cumulatively over these first two quarters. If you look forward, I think it's worth noting a couple of things. Our updated guidance, sort of what our updated guidance accounts for and anticipates, as well as maybe what it doesn't fully factor in. First, we'd expect our U.S. business will grow faster in the second half of the year compared to the first. We did mention that in our prepared remarks. That's largely driven, obviously, from Flash, Bolt, and SENDit.
It also reflects our expectation that growth in peripheral thrombectomy, both in the U.S. and globally, will accelerate in the second half of the year. The last thing I'd say is, we're excited about what we're seeing in the hospital submission process with an unprecedented number of largely new accounts pending. The timing, obviously, of these processes is, is variable, it can take anywhere from a few months to up to nine months plus. I would say we have been appropriate about how we're factoring this into our guidance at this stage. Overall, we have, I think we have a lot to look forward to the balance of this year and into the next year.
Bill Plovanic (Managing Director and Equity Research Medical Technology Analyst)
Thanks for taking my questions.
Adam Elsesser (Chairman and CEO)
Thanks, Bill.
Operator (participant)
Your next question is from the line of Robbie Marcus with JPMorgan. Your line is open.
Robbie Marcus (Senior Analyst)
Great. Thanks for taking the questions. Maybe to start on peripheral vascular, looks like U.S. was up 50%, the rest of the business was flat. Maybe you could just walk through what's going on there trend-wise. You know, is, is there a headwind or slowdown in coils, anything outside the U.S. to point to? You know, the, the vascular business was a little bit below the street. Just trying to understand, you know, great U.S. growth, but, but what happened to the rest of the vascular business?
Jason Mills (EVP of Strategy)
Yeah, thanks for the question, Robbie. Overall, we think the vascular business had a really strong quarter. Obviously, the U.S. You mentioned the U.S. peripheral thrombectomy business was up, was up 50%. The U.S. total thrombectomy business, stroke was up over 40%. Internationally, there are obviously both coils and thrombectomy is really generally fairly early. We have Lightning 12 and Lightning 7 just getting started internationally, and there's a lot of work to do. I wouldn't say there's anything untoward going on, we just don't have all of our premium products internationally. And in the United States, it's really expected to drive that growth. I think the guidance reflects what we expect from our vascular business, really strong, accelerating growth, especially driven from the U.S. market.
Adam Elsesser (Chairman and CEO)
Yeah, and to be honest with you, we look at that as the opportunity as we bring these products, particularly Flash, and Lightning Bolt 7 and, RED 72 with SENDit, and Thunderbolt, to those markets, because then we'll have the opportunity to have a similar growth, continue in the International markets. It's really driven by the innovation, the technology that has always defined us.
Robbie Marcus (Senior Analyst)
Maybe to just hit on some of the sequencing. You, you gave us, I believe it was 23%-25% growth in third quarter, correct me if I'm wrong, and greater than 30% in fourth quarter. That's, you know, lower and higher than what the street has for third and fourth quarter. Maybe just walk us through some of the puts and takes there, and your confidence in that greater than 30% number in fourth quarter. Thanks a lot.
Jason Mills (EVP of Strategy)
Yeah, thanks for the question, Robbie. We did point that out. As you know, we don't typically guide quarterly, but we thought it was important to recognize the third quarter. I think the way that the third quarter had been sort of modeled from a consensus perspective, underappreciated the momentum in the United States and the International markets was just a little bit too high. That's the put and the take in the third quarter. I think where, you know, we expect to get the growth, not just next quarter, but for a little while, is the United States market. I think that's where folks want to see our growth, because that's where Flash and Bolt are exclusively at this point.
In the fourth quarter, the comps on a year-over-year basis internationally, are just not the same as they, they are in the third. As we mentioned, expect double-digit growth. Again, that's compounded with a U.S. business that will still have plenty of momentum, obviously, as we've said, coming out of the second and third quarters.
Robbie Marcus (Senior Analyst)
Great. Thanks for taking the questions.
Adam Elsesser (Chairman and CEO)
Thanks, Robbie.
Operator (participant)
Your next question is from the line of Larry Biegelsen with Wells Fargo. Your line is open.
Larry Biegelsen (Managing Director and Senior Medical Technology Analyst)
Good afternoon. Thanks for taking the question, congrats on a nice quarter here. Adam, just two clarification questions up front. The Thunderbolt delay of 12 months, what was the basis there? Filing, was it filing by the end of 2023, is that pushed out to filing now end of 2024?
Adam Elsesser (Chairman and CEO)
Yeah, we'll get all the specifics, timing of that out when I told you when finished up with the. Generally, you know, I wanted to quantify it with the, the, the extended of about 12 months. The most important thing, really, really want to stress this, we are not the performance, and you can see it in our numbers for the second quarter in a row, the performance of our neuro business is not waiting for Thunderbolt. We have this unbelievable premium product that is capturing share. It is the talk of SNIS that we were just at. We are in really, really good shape. Then on top of that, when Thunderbolt comes, we get to deal with the other part of the procedure, not just getting there, but making sure that in every case, we can get the clot out.
I, I, I want everyone to be very, very clear, and I appreciate your question, Larry, that the setup for us, the ability to go after both parts of this procedure now, are critical. I think everyone knows how important trackability is. You know, it was a topic for quite a while around us in, in our stroke gathers. The fact that we have a product that is doing such an amazing job and taking such share, leading to, to my comment that I think we'll, we'll get the dominant share, is great. Then to add Thunderbolt on top and to see, you know, how that will continue the growth curve of our stroke business is, is a great sign. Thank you for the question.
Larry Biegelsen (Managing Director and Senior Medical Technology Analyst)
Yeah. Adam, I'm just wondering, to follow up on Robbie's question, you know, embolization's been a good business for you, growing, you know, mid-teens at least. What did it do this quarter? I'm wondering if the sales force is perhaps distracted launching two products. I just want to sneak one in on vascular. It seems hard to get to how, you know, vascular is gonna grow faster than neuro for the year, given the first half neuro has grown so much faster than vascular. Thanks for taking the questions.
Adam Elsesser (Chairman and CEO)
Yeah. Really good follow-up questions. The first one on the coils, you know, we're already in a majority market share with coils, so by definition, that is gonna slow down compared to, you know, the beginning of, you know, the two most significant launches in our company's history. I think the numbers are fairly obvious when you do that. Don't get me wrong, everyone's proud of our coils. They do great work and have a significant clinical benefit. Just by definition, that's gonna happen. The question around vascular, I think we answered it in the script. We have way more hospitals coming on board with Lightning Flash and Lightning Bolt than we already have. We're closer to the beginning.
I made a pretty specific comment that we have well over 1,000 submissions in the U.S. alone for Flash and Bolt. We are way cl- these are mostly new customers, that process, as it plays out, will obviously drive. This is folks who have seen it, used it once, going through the submission process at their hospitals. The scale of this is different than any other product we've ever launched in our company's history. I just wanted people to understand that. That means it might not happen in one day, but it's, it's happening.
I got to give, it's a testament to the, the, the sales team for doing the work to, to get that going, but also to just the extraordinary innovation that is driving that many new customers to want to use this product. I think when you do the math around that, the question around vascular growth takes care of itself.
Jason Mills (EVP of Strategy)
Yeah, the only thing I would add is just from a numbers standpoint, Larry, I think vascular globally was about 58% of our total revenue. That will climb in the third quarter a little bit, perhaps slightly below 60%, then we likely will be over 60% of our business, vascular, globally in the fourth quarter.
Larry Biegelsen (Managing Director and Senior Medical Technology Analyst)
Thanks, Jason.
Operator (participant)
Your next question comes from the line of Margaret Kaczor with William Blair. Your line is open.
Margaret Kaczor (Senior Research Analyst)
Hey, good afternoon, everyone. Thanks for taking the questions. I wanted to really follow up on two pieces. One, get a sense of the scale, I guess, of the 1,000 active hospital submissions, for approval for Flash and Bolt. I'm not sure if you'll be willing to give us, you know, what number of hospitals, I guess, you're at today, you know, relative to the hospitals that you're targeting and that 1,000+, you know, as we look out versus the potential accounts, right? Then, you know, a similar question on the adoption curve of those maybe that have trialed Flash and Bolt. Can you give us a sense of kind of their scale?
Is it, you know, month one, try a few cases, kind of put it to the side, bring it on, or is it kind of inflection is reached relatively quickly just as, as we go on throughout the year? It'll give us a sense of, of growth.
Adam Elsesser (Chairman and CEO)
Yeah, really great questions. Let me do my best to sort of answer it. The, the, the answer of what is well over 1,000 submissions mean, the, the best way to talk about it is, it's we're closer to the beginning of this launch than we are to the end of this launch, okay? That's, that's the, the right way to sort of put it in, in a frame. We have more to go than, than has already been accomplished. Really ramps up, you know, you can't really, you know, other than maybe one or two cases, you can't really use a product without it being formally brought on through this process. That's the gating item. We have a lot to go to get that going.
Once somebody does bring it on, so far, our experience has been that it's, it's pretty sticky business. I think that's partly what is driving new customers that we haven't had before to be so interested. Word of mouth, physicians talking to physicians, sharing their experiences, that has been very sticky. You, you tend to have a lot of, you know, a lot of physicians wanting this to happen as fast as possible so they can start to get using this. That is why you hear the confidence we have about, you know, not just the rest of this year, but, you know, going into the, the, the prior, the future years as well. We just not, have not had an experience like this, where, where the technology itself is driving a, a scale of adoption or interest, like we have seen.
Margaret Kaczor (Senior Research Analyst)
Okay. Then, you know, you, you've referenced yourself kind of the 30%+ growth as we get into Q4. I know the comps obviously this year are easier than they will be in 2024. You know, how should we think about that? Because you've got the street at mid-teens. All the commentary you're saying is, is so positive, right, both on vascular, even on neuro. You know, it just feels like it's a, it's a pretty rapid deceleration, which is not what the commentary is suggesting. Maybe just true up those two, you know, comments versus numbers. Thanks.
Adam Elsesser (Chairman and CEO)
Yeah, you know, it's still summertime, so I hope you don't mind that I'm not going to give guidance for 2024 in the middle of summer for 2023. I, I think you can take our commentary and what we're sharing about what we have in front of us as the best sign of our confidence. To quantify that down into a percentage is a tough premature at this point, but, but that's not in any way to not be enthusiastic about all three of those products that we're, we're currently launching.
Margaret Kaczor (Senior Research Analyst)
Okay, thanks. I had to try.
Adam Elsesser (Chairman and CEO)
I appreciate the effort.
Operator (participant)
Your next question is from the line of Joanne Wuensch from Citi. Your line is open.
Speaker 14
Hey, good afternoon. This is Anthony on for Joanne. Thanks for taking our questions. I think last quarter you called out supply as maybe a headwind or gating factor to Flash update. Just curious if that was the case this quarter again, and then just as a quick follow-up, can you just talk about adoption trends you're seeing with Flash in PE cases versus DVT? Thank you.
Adam Elsesser (Chairman and CEO)
Yes, great question. Thank you. you know, we, we did not have to really focus on supply. I mean, don't get me wrong, the operations team is working incredibly hard to ensure we don't have that issue. I very particularly at the beginning of the quarter, said we didn't expect that to, to limit us, the real. We're hoping to keep ahead of that curve, going forward, and the team is working diligently. As it relates to PE versus DVT, we're not really seeing a difference. you know, there are, obviously, you know, competitive reactions and physicians who are gonna have different viewpoints to start.
What we're seeing is both of those areas, whether it's PE case or DVT case, are incredibly successful, and physicians are responding to that. Some might start with one and then navigate to the other and vice versa. There's not a trend that I would yet point out that one is better or different than the other at this point. I don't expect that to be the case, given the sheer volume of cases and the success we're seeing.
Speaker 14
Great. Thank you.
Adam Elsesser (Chairman and CEO)
Thank you.
Operator (participant)
Your next question is from the line of Matthew O'Brien with Piper Sandler. Your line is open.
Matthew O'Brien (Managing Director and Senior Research Analyst)
Great. Thanks for taking the question. Maybe just to tease out this, this back half acceleration, because as I look at the stock down about 5% in the aftermarket, I'm sure some of it's Thunderbolt, but probably more on the vascular business, even though the U.S. was awesome. I, you know, because we have a bigger, you know, second-half ramp, and Jason, you know all about, about, you know, the big second-half ramps and concerns around those. What's assumed as far as hitting the Q3 acceleration, Q4 acceleration, with the vascular business in terms of these active submissions and converting them to, to, to users or existing hospitals, you know, bulking up their utilization?
Jason Mills (EVP of Strategy)
Yeah, I'll, I'll maybe take the front end of that, Matthew O'Brien. Thanks for the question, and then, then Adam can clean up after me. The third quarter growth, you know, is a pretty strong range. The guidance, obviously, in the third quarter, at the top end, 25%, off of, you know, a pretty strong third quarter of last year. We think that that will be driven by the United States. I mean, it's hard to accelerate off of the growth in the United States that we put up in the second quarter. We think we can at least do that growth and maybe show some acceleration in the third. We also commented, and you asked about it, and I'll turn it to Adam to answer more thoroughly about the submission process.
When I say we've been appropriate with respect to what we factored in, I, I think that, you could read that to mean that we're, we're being appropriate. We're not factoring in things that we don't have control over timing or other things, notwithstanding that when the submission process starts, we have a history of having a high degree of success getting through it positively.
Adam Elsesser (Chairman and CEO)
Yeah, I don't-- I think you answered that really well. I don't have anything specific to answer other than, you know, there- we've always looked at our guidance and, and done it as very realistic and making sure that we're giving the complete information around this. That's why we're sharing you the number of submissions in hospitals for both Flash and, and both in some of the commentary around SENDit, because that also is going to be a pretty significant part of our neuro growth for, for quite a while.
Jason Mills (EVP of Strategy)
Just lastly, I'll just add on to those comments. Usually, as you probably know, Matt, the fourth quarter or the third quarter internationally tends to be a bit seasonal, and then the fourth quarter is the strongest quarter. That's reflected in, in this guidance. We, as a matter of fact, put our expectations for growth internationally for both the third and the fourth quarters. That's reflective of that sort of normal seasonal trends and what we know about our business internationally, concomitant with what we expect in the United States from those three products we've talked so much about on this call.
Matthew O'Brien (Managing Director and Senior Research Analyst)
Got it. Appreciate that feedback. One more quick one. Everybody's talking about looking ahead in, in terms of all these new active centers that are that are reviewing, you know, the new products, but what about ones that have adopted, have gotten through the VAC? What are you seeing in terms of utilization trends, and then specifically reorder rates? Are you seeing, you know, 90s plus reorder rates from these from these accounts?
Adam Elsesser (Chairman and CEO)
Yeah, it's, it's a great question. Let me, let me try to answer that. The answer is, the reorder rates for this product are obviously extraordinarily strong. Without that, you wouldn't have all of these new customers that otherwise never wanted to ever use our thrombectomy products. That's being driven by the excitement that people who are using the product today and talking about it. The two are, are linked. There is still room, and this is, I think you all know this, you know, having, you know, watched it and, and been in this field for a long time. You have multiple physicians, and in our particular area, you have multiple, you know, subspecialties of physicians, up to three different ones in every hospital.
When a hospital gets the product in, it doesn't mean that, in some cases it does, but not always, every single physician in all three sub groups are now starting to use it. There is still room, in addition to the new places coming, for a significant opportunity over the next period of time to drive additional usage within the hospitals that have already been approved.
Matthew O'Brien (Managing Director and Senior Research Analyst)
Got it. Thanks.
Adam Elsesser (Chairman and CEO)
Thank you.
Jason Mills (EVP of Strategy)
Thanks, Matt.
Operator (participant)
Your next question comes from the line of Pito Chickering with Deutsche Bank. Your line is open.
Pito Chickering (Healthcare Facilities and Medical Devices Analyst)
Hey, good afternoon. A nice quarter. You quantified how much the U.S. vascular, you know, grew for 50% year-over-year. How much of that grew sequentially from the first quarter? Then you guided to U.S. growth accelerating largely in the third quarter. Again, from a sequential perspective, how much we consider the U.S. vascular market growing from 2Q into 3Q?
Jason Mills (EVP of Strategy)
Yeah, we didn't quantify the sequential growth. What we said was, actually, we did in such that we said U.S. venous in total grew sequentially strong double digits, and U.S. arterial also grew double digits. That's the vast majority of it. We, we had another strong quarter in coronary as well. It didn't grow quite as fast, but on a year-over-year basis, was double digits as well.
Pito Chickering (Healthcare Facilities and Medical Devices Analyst)
Okay, great. Then on, on margins, you know, EBIT margins built nicely for this quarter with the strong revenue growth. Can you provide any updated guidance on how, how we should think about exit rate for the fourth quarter of this year?
Jason Mills (EVP of Strategy)
Yeah, I'll start, then maybe with respect to your latter part of your question, we indeed, as I said in my prepared remarks, expect to be above 10% operate, you know, pro forma operating margins as we exit 2023. I think importantly, that is not a place we see it stopping. We see continued expansion subsequent to that in 2024 and beyond. Maggie, what would you add to that?
Maggie Yuen (CFO)
No, I think you, you sum it up well. I mean, with continuing favorable mix and volume leverage and continue to scale, that's the trend we'll continue to see throughout the year.
Pito Chickering (Healthcare Facilities and Medical Devices Analyst)
Great. Thanks so much.
Operator (participant)
Your next question comes from the line of Shagun Singh with RBC Capital. Your line is open.
Shagun Singh (Senior Biotechnology Analyst)
Great. Thank you so much. I just wanted to ask the 2024 question, perhaps in a different way. I'm just trying to figure out what year two looks like versus year one. You know, you have talked about this being a multi-year launch. You know, you've talked about at least a five-year runway. As we think about year two, and, and it does also seem that there's a process to get the product on board. As you think about year two, do you expect, you know, growth to be stronger, similar, you know, or below 2023? Just, just anything that can help us handicap the opportunity better would be helpful.
Adam Elsesser (Chairman and CEO)
Well, first of all, thanks for the question, and as importantly, thank you for giving me the heads up that you were gonna ask that question and try to frame it in a different way. I'll repeat the answer. It's still summertime in 2023. So we're, we're not gonna obviously answer that in, in the kind of specifics. What I, what I really want to sort of maybe summarize the comments we've made this quarter around what's ahead of us, is not to sort of differentiate between what's behind us and what's ahead of us, but just to explain the level of interest deep into our subspecialties at a place and a way that we have not ever seen before, in any product we've ever launched.
That's pretty exciting because it means that the products are working, they're doing work. When you go to, for example, a vascular surgeon who has done open surgery on the arterial side for years and years, and has never wanted to even listen to our prior generations, and now is intrigued when they see Bolt and does one case, and then tells us that they've gonna convert over to everything. That's not happening. You know, that's not normal, and it means that there's a lot ahead of us, and that's an exciting moment for us. How do we quantify that between 2023, 2024, 2025, and going forward? It means we have a lot of work ahead. We have to do the work, we have to get in the hospitals, we have to make sure, we have that.
All of that is positive, and it puts us in a really good shape. I apologize for not being able to quantify it for 2024 yet. Obviously, we will at the appropriate time. We're, we're in a really good spot, and we're pretty excited about it. We know we have the work to do, but this is these launches are different, all three of them, than things we've had before.
Shagun Singh (Senior Biotechnology Analyst)
Got it. Then just a question on margins. You know, I was just wondering how you're thinking about getting to beyond the +10%, so, you know, maybe +20%. You know, perhaps you can help us think through, you know, margin expansion, you know, this year and in the, in the future years. Do you expect it to be more linear, or should we think about it differently? Just any directional color would be helpful. Thank you for taking the question.
Maggie Yuen (CFO)
Yeah. No, thanks for the question. In terms of margin, I think in Jason's portion, we confirm or continue to target the 70% growth margin in a few years. I think between 2023-2024 and beyond, we are on a pretty good pace to directionally continue to see the same expansion. And that's also translate to the operating margin trend as we continue to scale pretty well and have infrastructure in place to allow us to scale and allocate resources effectively. I think what we have seen so far in terms of margin expansion trend, we can continue to expect that going forward in the next year.
Shagun Singh (Senior Biotechnology Analyst)
Thank you.
Adam Elsesser (Chairman and CEO)
Thank you.
Jason Mills (EVP of Strategy)
Thank you.
Operator (participant)
Your next question is from the line of Sam Brodsky with BTIG. Your line is open.
Speaker 13
Hey, can you hear me okay? It's actually Ryan on Sam's line. I'm at SNIS, so I was calling in on his line.
Adam Elsesser (Chairman and CEO)
We can hear you. Yep, we can hear you.
Speaker 13
Oh, good. All right. Hey, guys. Two questions. I'm, I'm here listening to all the clinical sessions and, you know, it's clear you're competing for patients in these trials with Thunderbolt. Just, Adam, I want to understand kind of your view on cyclic aspiration today versus maybe what it was, you know, one year ago or kind of as you embarked on this endeavor. You know, has it changed, or how has it not changed in terms of, you know, the opportunity in the market for cyclic aspiration relative to maybe things like large bore aspiration, and kind of what you think that can do when Thunderbolt does eventually come to market?
Adam Elsesser (Chairman and CEO)
Yeah. It's, it's a great question and, and it is an appropriate one, given that you're right in the middle of SNIS right now. Let me just. A couple of terminologies to make sure we're all on the same page, and then, I really, really wanna, 'cause that this seemed like the third or fourth question that, that is being asked, and I'm not sure why what I'm saying is not registering. Cyclic aspiration is something different. We don't do cyclic aspiration. That's turning a pump on and off. It, it means nothing. It doesn't have any real effect. Modulated aspiration is very different, that's what Thunderbolt does. It's also what Lightning Bolt does. Obviously, we've treated, you know, like 1,000 patients now with Lightning Bolt, and it's, as I just said, it's extraordinary.
It's amazing technology that is changing people's thoughts about treating patients after years of doing something else. So there cannot be any misunderstanding about my level of enthusiasm and excitement about modulated aspiration to get clot out of the body. I want that to be crystal clear. Now, there's a question of now, as neuro of, you know, Thunderbolt, you know, large bore aspiration. Large bore aspiration catheters have been around for a while. None of them, and my understanding are actually clear. They're either in a trial or they have a guide catheter indication or being used off label because they're in a trial. There's a bunch of those trials going on. Those are typically guide catheter sizes where they're trying to push them up to the M1. You can ask around whether that's, you know, currently in fad or not.
I think the answer is fairly obvious. Let's focus on the most important thing to start a stroke case. You got to get there. You got to get there. We now have a technology that brings a appropriate size catheter up to the clot faster and easier than any other product we've ever had or anyone else has ever had. That should be something we're excited about. At the same time, we're also excited about Thunderbolt and the results of that, and we can't wait for that to come out because we already know, both in the trial and obviously with Thunderbolt, Lightning Bolt being used so much, how it works. It's a that long process. It doesn't happen, you know, immediately.
It will take a little longer for Thunderbolt, but in that time period, we don't have to wait to do what we're doing, which is taking significant share and likely growing the market at the same time. I was just there yesterday, I apologize for missing you, but the level of enthusiasm is at an all-time high. It's back. Pre-pandemic levels of enthusiasm. We had meetings with physicians who are talking about going into the community and doing the work necessary to drive this. In large part, it's around the idea that access, getting to the clot with an appropriate-sized catheter like RED 72 with SENDit is the, is the answer. I want to. There, there, there is a terrible misunderstanding if anyone thinks I'm, you know, what I'm saying about Thunderbolt is a negative. Thunderbolt is great.
It's also nice to have something equally great that does something else, which is RED 72 with SENDit.
Speaker 13
Crystal clear, Adam. Thank you for saying that. You know, last question for me. You talk about pricing and the benefit you're getting in that quarter for Lightning, or, you know, you talk about the benefit you're getting on SENDit with RED 72. Can you give us any color in terms of the pricing benefit relative to, say, a volume mix assumed in your guidance, given that you are getting some premium on price for these technologies when we think about guidance for the remainder of the year?
Adam Elsesser (Chairman and CEO)
Yeah. That's a really, really good question, and I'm glad you, you asked it. I mentioned pricing, you know, really for a slightly different reason. You know, we just have a simple system. We got a price, it's easy, everyone knows it, and we're hearing that that is a valuable, a valuable way to conduct business. That being said, we're always, always have been priced fairly, and that's been our reputation out there, and that stays our reputation. I think that's important because, you know, you're in business for a long time, your reputation and, and how you conduct yourself and, and what price you charge is fair. That being said, obviously, there's a small premium for our, our products. We talked about this for the new products.
It's a little bit mitigated because like with Flash, you don't need a separator. So the vast majority of our guidance and, and, and success in the past, couple of quarters, is being driven off increased usage of the products, not pure price. The reason that's important to say that, one, it's true, but more importantly, is it's sustainable. You know, price has a short shelf life to it, and, and it's not something that we've ever, you know, we'll take an appropriate price when necessary, but we want to grow our business with sustainable share gain and market growth, which is very different than a short-term, one-year bump for price.
Speaker 13
Thanks. Thanks, Adam.
Adam Elsesser (Chairman and CEO)
Thank you.
Operator (participant)
Given the time, your final question on today's call is from the line of David Rescott with Baird. Your line is open.
David Rescott (Senior Research Analyst)
Oh, great. Thanks for taking the questions and congrats on the strong quarter. Maybe I'll start off, Adam, on your comments around, you know, an expectation for a dominant share in the U.S. stroke space within the next three to four quarters. I guess, you know, one, more basic question, should we assume that this implies that you expect to have a majority share in the U.S. stroke market within the next three to four quarters? And I guess, given the longer timeline to Thunderbolt, does this, you know, imply that SENDit is, is generally what is getting you to that dominant share position, rather than, you know, more or less being dependent on Thunderbolt?
Adam Elsesser (Chairman and CEO)
Yes. Oh, you want me to expand on that? Yeah, the answer is yes. SENDit, and that's what I meant by we don't have to wait. When Thunderbolt comes, there'll be more fun, we'll have more growth. It will add to our benefit in the future, but we don't have to wait for that benefit now. We have and when we first started talking about Thunderbolt, which is a few years ago, we didn't have SENDit. Didn't know that we would not have to wait. The fact that we don't have to wait, and we all thought we did, and now we don't, is a positive. It's really kind of exciting. To see, you know, we had a tech suite at SNIS. We had physicians who were trying, you know, the products without SENDit, and, you know, they were getting stuck around the curve.
They then tried it with SENDit and sailed right up over and over again. The reaction is like: "Whoa! You know, that's amazing." You know, that's, that's about patient safety. It's about getting the clot out fast, because, again, if you're using Thunderbolt to get the clot out and it takes a minute or two, but it took you 45 minutes to get there, there's still room for improvement in that case. If you can get there in a minute or two, and you can get the clot out in a minute or two, then you've really done the work. We're doing the work now to get the first part of the case, the most, you know, important, getting there, and then we'll add to that with Thunderbolt when it comes. Frankly, you know, that feels like a pretty good setup for success for many years.
David Rescott (Senior Research Analyst)
Okay, now that's, that's helpful. Thank you for the, the, the longer answer there. I guess my second question, just on the, you know, the, the margin, gross margin, operating margin, longer term goals. I think you said maybe the, you know, above 70%, gross margins within a few years. You know, wondering if you'd be able to qualify that as, you know, maybe closer to the two to three-year timeframe or something that's, you know, within, within a five-year view.
And then just wondering more or less on the operating margin side, just based on you are, with the launches, with, with kind of the sales force today, should there be any thought about, you know, accelerating or any incremental spend maybe on the sales force side, in back half of this year and, and into 2024? Are you kind of set with where the business is today? Thank you.
Maggie Yuen (CFO)
Yeah, no, thanks for your question. I think in, in terms of the gross margin, yeah, I, I, I think we previously mentioned two to three years out is, is, is the, the right target to look at. We'll continue to see all the favorable factors that we've been seeing, both margin and both mix and volume and scalability.
Adam Elsesser (Chairman and CEO)
On, on the sales force side, it's a really, it's a good question. We really we have an incredible team, and we cover the whole U.S. pretty effectively. We may have to add, you know, one person or two person, you know, here and there as territory grow. For the most part, we're not gonna we're gonna be able to get some real leverage there. We don't think we'll need. You know, this is sort of the busiest they'll be because they're launching these products, they're going through the process in all these hospitals, and they're doing, you know, case coverage, and they're, as somebody raised the coil business. I, I think it will get, you know, over time, you know, more normalized. Our team is amazing.
You know, I called them out in the prepared remarks for just the sheer volume of work that people have done in the first half of the year. I think we'll get a lot of leverage out of that, because I do not think we need to fundamentally change the, the size of the team.
David Rescott (Senior Research Analyst)
Thank you.
Operator (participant)
At this time, I will turn the call back to Ms. Hamlyn-Harris.
Jee Hamlyn-Harris (Investor Relations Officer)
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.
Operator (participant)
Ladies and gentlemen, this concludes today's conference call. You may now-