Good afternoon. My name is Chantal, and I will be your conference operator today. At this time, I would like to welcome everyone to Penumbra Second Quarter 2019 Conference Call. [Operator Instructions] Thank you. I would like to introduce Ms. Jee Hamlyn-Harris, Investor Relations Penumbra. Ms. Hamlin Harris, you may begin your conference.

Thank you, operator, and thank you all for joining us on today's call to discuss Penumbra's earnings release for the second quarter 2019. A copy of the press release and financial tables, which includes the 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-Q for the quarter ended June 30, 2019, which will be filed with the SEC on August 6, 2019, as well as those described in our 10-K for the year ended December 31, 2018, which was filed with the SEC on February 26, 2019. 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-Q and 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. A reconciliation of GAAP to non-GAAP financial measures is provided in our posted press release. We anticipate the prepared comments on today's call will run approximately 13 minutes. Adam Elsesser, Penumbra's Chairman and CEO, will provide a business update; and then Sridhar Kosaraju, our CFO and head of Strategy, will discuss our financial results for the quarter and an updated revenue guidance range. With that, I would like to turn over the call to Adam Elsesser.

Thank you, Jee. Good afternoon, and thank you for joining Penumbra's Second Quarter 2019 Conference Call. Our total revenues for the second quarter were $134.2 million, a year-over-year increase of 22.4% as reported and 23.8% in constant currency. We had operating income in the quarter of $12.8 million compared to $9.3 million for the same period last year. As we finished the first half of 2019 our business continues at great momentum and growing opportunities to help more and more patients. Our overall revenue growth has been driven by the ischemic stroke market as well as our ability to develop new and significant opportunities within the vascular market. On today's call, I would like to focus on two important updates. First, as you may remember on our last earnings call, we spent time discussing a number of patients that could be treated in the United States with peripheral thrombectomy. When we first launched our Indigo System four years ago, we estimated that 150,000 patients could benefit from our system. Now four years later, with greater understanding of the variety of cases and with advancements in training and techniques, we believe the Indigo System has the potential to address over 350,000 patients per year in the United States. This figure represents a number of patients with clot in the body who are currently being treated, either surgically or interventionally. It will take us time to penetrate this patient opportunity and future technology improvements will be important for us to do so. In addition, as the procedure improves and is made easier and easier, it is possible that the addressable patient opportunity could grow even higher. To put this into context for Penumbra, our current addressable patient opportunity in peripheral thrombectomy is larger than our estimates of the addressable opportunity in ischemic…

Thank you, Adam. For the second quarter ended June 30, 2019, our total revenues were $134.2 million, an increase of 22.4% reported and 23.8% in constant currency. Our geographic mix of sales in the quarter were 64% U.S. and 36% international. Neuro and vascular represented 61% and 39% of sales, respectively. In the quarter, we saw great momentum across our business, which resulted in sequential growth over an exceptional first quarter. Revenue from our neuro business grew to $81.5 million in the second quarter 2019, an increase of 9.9% reported and 11.5% in constant currency compared to the same period a year ago. Our neuro growth was primarily driven by sales of our Penumbra system for ischemic stroke. Through the first half of the year, we faced difficult year-over-year comparisons in neuro, particularly in neuro embolization. Additionally, as you may recall from our fourth quarter of last year, with the launch of our peripheral embolization products in Japan, we saw shifting of revenue from neuro to vascular. We have seen the stroke market growth and competitive dynamics both within our expectations. As we look ahead to the back half of the year, we are encouraged by our pipeline of innovation and the recent introduction of Penumbra JET 7 XTRA FLEX. Revenue from our vascular business grew to $52.7 million in the second quarter of 2019, an increase of 48.6% reported and 49.5% in constant currency. In the quarter, our vascular growth was driven by results from both our thrombectomy and embolization businesses. We are continuing to see accelerated growth from initiatives to reach new customers to introduce new technologies and to enter new geographies. As we head into the back half of the year, we expect to see our momentum continue but with normalizing year-over-year growth rates. Our gross margin…

Thank you, Sri. As we move into the second half of 2019, we have laid the groundwork for a new chapter of the Penumbra story. We have confidence in our ability to develop, produce and sell market-leading devices in our current areas of neuro and vascular diseases. We have also honed these skills and applied them in new areas, such as neuro rehab. Just as important, as the actual products, we are well underway in the evolution and growth of the entire leadership team at Penumbra. This starts with the addition of our new Board members, who'll be taking over leadership roles of key committees as well as the development and growth of our expansive and amazing management team. We have leaders, in many cases, three to five layers deep in specific departments and functions, that have developed the maturity in skills that allow us to have the strong conviction that we can continue to scale our growing business for many years to come. Our leaders are thriving. They take on new and additional challenges. With this capacity, we are excited to embark on the next chapter of the Penumbra story. Thank you. And now we'll open the call to questions.

[Operator Instructions] Your first question comes from Bob Hopkins with Bank of America. Your line is open.

Okay, great, thanks and good afternoon. Great result overall. A bit more weighted to vascular than we modeled. So I just want to ask a couple of questions on neurovascular to make sure I understand the moving pieces. The year-over-year neurovascular growth, you saw it a little bit relative to Q1? It was flat sequentially. Can you just talk about some of the dynamics in the second quarter neurovascular result that cause a little bit of decel in Q2?

Sure. Bob, it's Sri. So in the year-over-year context in growth rate that you mentioned, neuro obviously, there's three components within that franchise. Stroke, neuro embolization and neuro access. As we mentioned in our prepared comments, most of that year-over-year comp-related issue resides in neuro embolization. If you look at the U.S., obviously, we're focused in -- on stroke and if you look outside the U.S., in Q4, we highlighted a pretty substantial ship to revenues related to our Japan peripheral embolism launch. So it's really a shifting of revenue. It doesn't affect the overall level of revenues, but just where it resides. And some of that is settling down. So really the acute focus on the comp is really around neuro embolization. The other two franchise performed with good momentum.

Okay. And then just curious, if you could talk about -- a little bit about the feedback from SNIS on the XTRA FLEX aspiration catheter. Maybe just mention that the early feedback you're getting on the launch? And should that lead to perhaps an uptick in kind of neurovascular stroke growth as we look to the back half of the year?

Yes, Bob. It's Adam. Thanks, and a good question. As I alluded to on prepared remarks, the reaction from customers has really been pretty extraordinary. We have done a number of cases enough to give us a fair amount of confidence that, that is -- that, reaction is pretty universal. And obviously, as you know, this field does not standing still. It's constantly changing and evolving. But at this moment in time, with this particular product, we have a lot of confidence that in the back half of the year, we can continue to push this field forward with its performance.

Great. I'll leave it at that. Thank you.

Thanks a lot.

Your next question comes from Larry Biegelsen with Wells Fargo. Your line is open.

Hey guys, thanks for taking the question. So one on peripheral, one on neuro. So maybe, Adam, a little more color on what's driving the growth there? From a product standpoint, it sounds like it was pretty balanced with symbolization and thrombectomy. Maybe you can talk about, from an indication standpoint, from a physician specialty standpoint, just a little bit more color on what's driving the pretty extraordinary growth in peripheral? And then I had a follow-up.

Sure. On the peripheral side, let's touch on it, embolization part of the business, that continues to grow nicely. As we've said, I think a few times, as that product, which is -- it's a series of coils gets broader and broader exposure, we're able to start to have physicians think about types of cases that they might not have used traditional coil technology to treat but other types of embolization tools. And so we think that it's potentially sustainable for a while as we grow that part of the business. On the thrombectomy side, it really comes down to just the simple math that we're incredibly underpenetrated still. And as we get broader exposure and more and more physicians are starting to think about clot in the body differently than they did traditionally and sort of embraced the idea of just taking it out, we think that we can grow that business for some time. As I said, on the call, if the number is 350,000, and that's without adding potentially new areas or applications, I think we are in pretty good shape for growth there for a while.

Thanks, Adam. And then on ischemic stroke, could you give a little bit of color on U.S. versus OUS ischemic stroke growth in the quarter? And I'll give you an opportunity, there was obviously some public data from IQ via -- showing your U.S. aspiration businesses declining at recent months. It's a simple, obviously, but I thought it would be useful to hear your perspective on that data?

Larry, it's Sri, just to touch on the stroke. Obviously, there is a lot of data sources that are out there. We obviously are aware of them all. They all vary in where they come from, the type of information that they survey. We know our results. I think we have a pretty close touch given our presence and share in the market. We've always contended that the growth of the market is that, the bigger factor and sensitivity to our results. When we introduced our guidance early in February, we talked about the notion of sort of looking at the last three years of patient growth and thinking about 6,000 to 7,000 patients, more this year, that could be treated as a market. So that's high teens growth. That's in the U.S. And we feel like through the first half of the year that, that has been consistent with what our expectations and predictions have been. I think we feel, as we go forward, that continues to be our prediction for the year. As it relates to outside the U.S., there is a vast opportunity for us to treat stroke patients. The populations an instant so to speak for themselves. I think as we talked about in other calls, we expect some variability in our outside the U.S. business. A lot of that entering new markets, a lot of that with distributors, if you look sort of going back to Q4, Q1 and certainly, this quarter, I think we set the expectation that there would be some variability outside the U.S. in stroke. But I would just wrap all that up by saying, our overall stroke business is strong. It's got great momentum, and particularly, as we look forward to the back half of the year, we feel quite good.

Thanks for taking the questions guys.

Thanks very much.

Your next question comes from Jason Mills with Canaccord Genuity. Your line is open.

Hi, Adam, Sri. Can you hear me okay?

Yes. Hi, Jason.

Good afternoon. I wanted -- Adam and Sri, you talk about three topics and covered a lot on stroke and thrombectomy. I want to cover those areas in a little different way, and then also gross margin. On stroke, the setup in the second half of the year is a bit different than the first half. Sri, you talked a little bit about that, given the comp, and Adam talked about the XTRA FLEX launch and the momentum early there. Could you talk about your setup as a company in U.S. stroke in the second half of the year relative to that high teens procedure volume growth for the market, sort of juxtapose to the first half? And what you faced without XTRA FLEX in the first half? And then peripheral thrombectomy. I'm curious what sort of color you'd be willing to give, Adam, with respect to growth coming from uptake or utilization increases at existing accounts versus new accounts, using thrombectomy that otherwise were doing drips in here Q4? And then the last part, gross margins, you commented on it, but that's a phenomenal gross margin. Should we expect it to go back to the 65% level? Or with volume increases, should we expect to see that improve over time?

Jason, it's Sri. I'll just start with a couple of responses to your questions, and Adam can take a few of the other ones that you had asked. Related to stroke, I think you hit the nail in the head, and I think there's going to be -- I think as you look at the neuro division number, a lot of questions to look into the details of it. As I mentioned, there are tougher comps in the neuro in the front half of the year, and as you alluded to, the back half of the year the changes quite a bit. Neuro embolization, you can look at your own modeling of it. The comps changed quite dramatically as we head to the back half. So there is that sort of comp-related issue. But if we think about the thing that really matters, which is sort of, where is the business today, the momentum that we have in the business and how it's growing sort of sequentially, specifically in stroke. We are seeing that momentum, and with the market, which again, we continued to think it's a bigger driver of our results. And also with some of the new things that we've talked about here, as I said, we obviously feel like we got great momentum heading into the back half. Let me just comment on gross margins for second, and I'll let Adam sort of catch more on the JET 7 XTRA FLEX and peripheral questions. Gross margin, this is the highest gross margin that we have had as a public company. So we're obviously very enthused about it that the expectations we've set around gross margin is not to be driving that right now. So that truly is a very encouraging signs that we could achieve that in the current dynamic where we're growing quite rapidly, expanding operations and launching new products. But we are in the midst of launching new product in JET 7 XTRA FLEX. We believe that we will have other new projects to be launching it. And we're in the midst to really growing our capacity, not just in Alameda, but also, in Roseville, California, as well. So I think the right expectation that we would sort of share is that mid-60s, as we're going through this period. But I'll say, I think we are extremely encouraged that we hit 70% this quarter. And maybe, I'll let Adam touch on the remaining questions.

Yes, thanks, Jason. Let me touch briefly on the XTRA FLEX launch and how it sort of fits in, and then I'll try to answer the peripheral question. On the XTRA FLEX launch. So the first half of the year, I am extremely proud of the whole Penumbra team. We, as you know, are constantly facing new catheters launched in this field and have for many years, and the team has done a great job of reminding and educating everyone sort of what matters in this field. And it's a number of things: You need to be able to get the clot out as fast as possible, and you want to be able to track and navigate your product there, but you also then want to be able to sort of ingest the clot as fast as possible. And so with original JET 7, an engine, we really pushed the ball forward with the part of being able to have the largest catheter with the most sort of thrombus removal force. With this update to that product, being able to make it even more navigable has really going to give the team a lot of momentum going into the back half of the year. And as we also said, that's not the end of the line. That's not the last product out there. And we feel that there's more to come, then we'll continue to move that ball forward. So we're in a really positive and exciting phase, as it relates to our stroke franchise. Now on the peripheral side, a very specific question around where we're seeing the growth on the peripheral thrombectomy side, either adding new accounts or seeing existing accounts, expand the number of patients or the types of patients that they are treating. And the answer is really both. We're seeing both happen. It really depends on when and how through the Council or sort of coming on board, many times they come on Boards, specifically focused on one type of disease and expand beyond that. And so we're really the beneficiary of both, further penetration by new accounts as well as deeper penetration into existing accounts.

Thank you, both.

Thanks, Jason.

Your next question comes from the line of Robbie Marcus with JPMorgan. Your line is open.

Great, thanks for the question. Two for me. First, Adam, at the end of your prepared remarks, you made the comment that you're moving into the next chapter of Penumbra. And I know you guys are always excited about the business and the products. But I don't think I've heard you guys talk about the next chapters for several years now. Maybe, you could just give us a recap of why it's a next chapter? What to look forward to? And what you're most excited about?

That's a great question, and I'm delighted, Rob, to be able to sort of attack it. So we really have three areas that have, I think, made -- make up the next chapter. First, and I never want anyone to not believe that we care about this because we started out really treating stroke patients. And we are incredibly confident and excited about the products that we have now and coming in the future as it relates to our original franchise around stroke. And I think those products, both with FLEX currently but with -- the other ones as well provide a real catalyst for the future growth of that franchise for us. As it relates to our vascular business, having the understanding that our addressable market is growing and continue -- and can continue to grow, both with our existing products but with newer technology that will be coming in the future as well as the extract trial that goes into new areas. That's two more catalysts in the upcoming year, plus that will allow us to be very, very confident about that part of our business. And then finally, when you look at new areas and the reaction, broadly to what we're doing for neuro rehab and how the technology that we've developed is being viewed and reacted by the professionals in the field, it's incredibly heartening. I mean it's really exciting and motivating and that performs or provides yet another catalyst in the future. So when you add it all up, we feel like we're in a really, really good spot. And I really particularly wanted to highlight, not just the product side but just the extraordinary people that make up the Penumbra team, because they -- there are maturing and going into, as I said, just amazing leaders and have the capacity to take this that far. So it's a great time, and we feel particularly excited about it.

Thanks. And just a follow-up on Larry's question from before. Sri, I just want to make sure everybody understands because this is a big sticking point for a lot of people in terms of the stroke growth. And I think everyone understands the market is growing in high teens. We saw it even better last year, but so far, it looks like high teens. Just want to make sure, we understand what you're saying is that, the patients growing are high teens, there's a shift from stent retrievers to more aspiration, offset by some degree of share loss net-net, you're coming out to that high teens market growth? That's part a of the question. Part B, can you give us a sense of maybe where you stand and share in the U.S. versus your international markets, if you're willing?

Sure, Robbie. I'll answer it this to the best that we can and know that you're looking for some additional color around this. What I say is, I think the -- a lot of the parameters that we've outlined before are unchanged, and I think that's an important statement to make. I think there's a lot of questions on, are things changing in a way that's different than sort of what we've been discussing, expecting or predicting. Let's talk about the market. As I mentioned the market growth in the U.S., if we sort of focus on that for a moment, is moving along the expectation that we had around that 6,000 or 7,000 patients, and we see that through the first half, and we continue to believe, while the foundation is getting stronger, that, that is sort of the growth that we are experiencing today. We are of the feeling that there is a movement consistently towards aspiration as a mechanism, that obviously is a market phenomenon that -- it's hard to measure. It's from our experience, I think, some of our other folks and peers in this space have confirmed and validated that point. And then the third one, which is harder to measure is competition and people have a couple of things to evaluate there. What companies themselves are saying? What various market data sources are saying? And as I mentioned, we're aware of the market sources out there. I say all of them are very different, and they all collect information in different methodologies. And I think they're trying their best to be instructive. But obviously, we know our information our data and try to triangulate on that. It's been our expectation that as this market grows, we'll face more competitors, and as Adam mentioned, none…

Thanks for the color.

Thanks, Robbie.

[Operator Instructions] Your next question comes from Margaret [ph] with William Blair. Your line is open.

Good afternoon, guys. Thanks for taking my questions. Maybe the first couple for me, I'll probably leave it there -- it's on vascular. So I think you guys had earlier on the call had talked about not having full geographic coverage. and I'm not sure if you guys can give us any metrics in terms of some of that market development work, the coverage that you guys do have versus don't? And then any sense of kind of account developments, targeting of accounts, or how sticky some of that new accounts businesses?

Margaret, I'll touch on international piece, and I'll let Adam touch on -- your second question on sort of new accounts. Vascular, for us, is predominantly a domestic U.S. business right now. And as we've outlined the opportunity, you can tell we -- the 350,000 addressable patients were the U.S. statistic that we introduced on this call. That is a pretty significant opportunity, and there's obviously a lot of growth opportunity for us in the United States. We equally think there is an opportunity outside the United States. That's going to take some time to develop the first sort of geographic opportunity for us in vascular was in the fourth quarter with our launch of our peripheral coils in Japan. I think that we mentioned a couple of quarters ago so -- and that is just starting to get going. But we're really are not really in many of those other countries yet, which remains a future opportunity for us. And you'll hear about that in the future.

Yes. And Margaret, it's -- the question relates to sort of the -- maybe the U.S. business and how sticky it is. We have coverage throughout the U.S., but we're not fully penetrated in all the accounts. So we have that capacity it just takes time and education and really training physicians and their staff to think about clot in patients differently than they thought about. And that's been sort of the effort underway now for many years as we sort of take on that education process. The business typically is pretty darn sticky. I won't say it's a 100% sticky in every situation. There are times where people may resort back to what they know and have more experience with. But the business, I think I answered it, as it related to I think Jason's questions, the business is both sticky and there's opportunities to gain more and more at the same time in more and more areas and diseases or types of clot. But also, there's still a lot of room to go to penetrate.

Okay. So that then brings me to the next question, which was some of the TAM discussions you guys had at the front-end commentary. And so that increase for domestic, I think, you took it from a 150,000 to 350,000, which is a really nice job. So maybe talk to us about those changes? I assume that's still wasn't here DVT and PE. But are these patients that are already in the channel are receiving some sort of peripheral intervention? Or is this more a market development work and new type development that needs to be done to kind of get to those addressable cases?

Yes, I think that's a really important question. And we tried to answer that really so let me be even clearer. That number represents the number of patients that are being treated today for some form of clot in their arteries or veins, either surgically our interventional. And we understand that broader based on the work that physicians have done with our product. And so we've added the patients that we're surgically treated as well as some areas that we didn't really think were sort of mainline. But our product has done quite well. And so for that reason, just with the experience that we've had with our product, we've been able to sort of add those patients to our goal of going after. It doesn't include patients in which we don't have a specific indication for and areas where we think that number could grow even more. And those patients we will certainly talk about in the future when it's appropriate.

Great, thank you guys.

Your next question comes from Joanne Wuensch with BMO Capital Markets. Your line is open.

Good afternoon everybody. Two quick questions. Can you give us an update on how you're progressing with cataracts and the coronary effort?

Sure. So cataracts is two things. Not in those numbers that I just talked about. That is just the peripheral side of our business. So that's an additional group of patients. The product itself is performing quite well. It's a little different type of procedure than the vascular side directly in which, many times, the clot's really adjunct to something else. And the physicians using it in a much faster and more dynamic situation than where the clot itself is creating the issue. And the products performing incredibly well. We ended that area with no data and just the idea that using power aspiration in this form could be helpful at least for the limited patients that have severe clot burden. And I think for those people who are trying it and seeing that, they're coming to the conclusion that the device is done really, really well for them.

Thank you. And as my second question, you alluded to more information on your stroke rehab effort "later in the year." Is there a forum that we will get that? And can you just sort of give us an idea of how to bring the perimeter of what that might mean for you?

Yes. Joanne, we mentioned previously that we expect to share more information on the product outlying the market and our commercial plans or strategy. We haven't yet announced, specifically the venue or date. We plan to do that, but that will be the agenda for that meeting.

Thank you. Great, thanks.

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

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

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