Earnings Labs

AtriCure, Inc. (ATRC)

Q1 2015 Earnings Call· Wed, Apr 29, 2015

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Transcript

Operator

Operator

Good afternoon and welcome to AtriCure’s First Quarter 2015 Earnings Conference Call. My name is Joyce, and I will be your coordinator for the call today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today’s call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Lynn Pieper from Westwicke Partners for a few introductory comments. Please proceed.

Lynn Pieper

Management

Thanks Joyce. By now, you should have received a copy of the earnings press release. If you have not received a copy, please call 513-755-4136 to have one e-mailed to you. Before we begin today, let me remind you that the Company’s remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure’s control, including risks and uncertainties described from time-to-time in AtriCure’s SEC filings. AtriCure’s results may differ materially from those projected on today’s call. AtriCure undertakes no obligation to publicly update any forward-looking statements. Additionally, we may refer to non-GAAP financial metrics. A reconciliation of these non-GAAP measures with the most directly comparable GAAP measures is included in our press release, which is available on our Web site. And with that, I’d like to turn the call over to Mike Carrel, President and Chief Executive Officer. Mike?

Mike Carrel

Management

Thank you, Lynn. Good afternoon and thank you everyone for joining us today. We are off to a promising start in 2015 and are pleased to report strong first quarter results. Based on those results, we are raising our guidance for 2015 to a range of 123.5 million to 125.5 million, reflecting approximately 17% to 19% year-over-year constant currency growth. Last month we hosted AtriCure’s first Analyst Day and I want to thank those who joined us, both online and in person, to discuss available markets for our products. We are very encouraged by the feedback we continue to receive from physicians about their excitement for AtriCure’s solutions. Our key take-away from the discussion was the multi-billion dollar market opportunity ahead of us, which was further validated by the physician presenters. On today’s call, I will start with a quick overview of our results for the quarter, followed by an updated on our business, our clinical trial progress and education initiatives. Then I will turn the call over to our CFO, Andy Wade who will provide detail of our financial results. After that, I’ll come back to make concluding remarks and then open it up for questions. Turning to the quarter. Our first quarter revenue reached $29.9 million, an increase of 20% as reported and 24% on a constant currency basis, when compared to the first quarter of last year. We demonstrated solid growth across all of our product lines in the U.S. where sales grew 26% year-over-year. U.S. open-heart sales were up 19%, MIS up 26% and AtriClip sales were up 52% in this quarter. Open clip was up 41% while AtriClip Pro grew 89%. On the international front, sales increased 4% as reported 18% on a constant currency basis. As you know, the dollar has strengthened recently against…

Andy Wade

Management

Thank you, Mike. For the first quarter of 2015 revenue increased 20.3% on a GAAP basis to $29.9 million. On a constant currency basis worldwide revenue increased 24%. Revenue from product sales in the U.S. was $22.9 million, an increase of 26.3% from the first quarter of 2014. Revenue from open chest ablation related product sales in the U.S. increased by approximately $2 million to $12.4 million representing growth of 19% driven by our education and training efforts as we build the still underpenetrated market for concomitant surgical ablation. U.S. sales of products used in minimally invasive procedures increased approximately $900,000 to $4.3 million up 26.1% and driven by all MIS products. Of note was strong performance of the fusion product line, which was acquired at end of 2013. While we are pleased with the solid growth of the MIS business in Q1, we do still continue to believe that this business will only see modest growth here in 2015. Continued development of clinical data in support of MIS ablation for the treatment of Afib through trials such as our DEEP IDE study are critical to growing this market. U.S. sales of the AtriClip System during the first quarter of 2015 were $5.5 million, as compared to $3.6 million for the first quarter of 2014, an increase of 52%. We continue to be encouraged by the strong growth of this part of our business. The MIS AtriClip Pro business continued to show very strong results albeit on smaller numbers. International revenue grew 3.9% on a GAAP basis and 17.6% on a constant currency basis as compared to the first quarter of 2014 to $7 million. Strengths included the direct markets in the EU and certain distributor markets. Valve tool sales were roughly $800,000 worldwide with approximately $700,000 in the U.S.…

Mike Carrel

Management

Thank you, Andy. We are off to a good start in 2015. AtriCure continues to position itself as a leader in the surgical treatment of Afib with a full suite of innovative and unique products and unparallel commitment to training and education. We look forward to updating you on our progress during future calls. We’ll now open the call for questions.

Lynn Pieper

Management

Joyce, can we open the call up for questions?

Operator

Operator

[Operator Instructions] We do ask that you please limit your questions to one and one follow-up at a time. If you wish to ask another question, please queue-up for any additional questions. The first question comes from the line of Jason Mills of Canaccord. Please proceed.

Jason Mills

Analyst

So, first question just on the U.S. business Mike phenomenal results in the quarter. You mentioned the MIS business, really strong results better than we expected by a wide margin, you don’t expect that to continue. But how would you expect the DEEP AF trial as it gets ramped up to impact that line and sort of some excitement around that trial? And then also in the U.S. the AtriClip business continues to chug along. Do you expect growth to come down a little bit via difficult comps as the year progresses? And also just how you’re thinking about the Watchmen launch just opposed to the AtriClip business?

Mike Carrel

Management

Well I appreciate the question there is a lot in there. So hopefully I’ll answer all of it. I’ll start with the MIS as you kind of talked about. We had a great quarter as you mentioned and we obviously feel really good about the overall platform and where things are going in that front. Fusion actually drove a lot of the growth in that market. We started to see some of the impact of having Fusion which came from the Estech acquisition in our hands for over a year now and we’re starting to see some of the impact on that. But like you said, there’re more difficult comps as the year kind of progresses. If you remember about a year and a half ago, we saw nice big blip and nice growth out of MIS only to have it come down a little bit on organic basis. So, we want to be conservative. We’re supper encouraged by it. We do think the DEEP trial will continue to garner great recognition out in the marketplace. It is going to be getting interest and we’re getting a lot of interest from different surgeons and EP’s and we’ve spent a lot of time on that. But we’re just trying to be conservative just because we can’t go out and proactively market. And so as a result of that, it’s really kind of just -- the market and the industry kind of doing it on its own. And that’s why we continue to remain conservative on it. Clearly, MIS is upside to our numbers and our story for the year as we kind of go through it. But we wanted to kind of keep it as upside as opposed to kind of baking it too much into the guidance that we’ve got…

Jason Mills

Analyst

Following up Andy on your gross margin commentary, fantastic results there as well and it looks like you’re a little bit ahead of plan. But was there anything besides the U.S. mix maybe a little higher in the quarter that contributed on a one-time basis. And how should we -- you gave your guidance raised a little bit there but how should we sort of gate the quarters from here on out? Thanks guys.

Andy Wade

Management

Sure no problem Jason I think the U.S. mix definitely was the biggest thing driving margin in the first quarter. Additionally, the Estech stuff from last year was in there was material for that. Those are really the two biggest things. As far as the rest of the year, I think you can gate it pretty consistently through the year. Obviously mix is going to impact that. So, we’ll continue to watch that closely.

Operator

Operator

The next question comes from the line of Danielle Antalffy with Leerink Partners. Please proceed.

Danielle Antalffy

Analyst · Leerink Partners. Please proceed.

Mike could you give a little bit of an update you’ve given in the past on where you stand as far as the various phases of training and you’ve talked about there is three different phases. Maybe talk about where you are now this quarter and how should we think about that contributing to accelerating growth as we move throughout the year?

Mike Carrel

Management

Sure, the phases as you kind of and I guess as a reminder for those is that the first phase is really kind of the core Maze IV training course that we did and that was kind of the basic two-three hour didactic course that kind of got you familiar with what the Maze was, where to put the lines. That was the one that we did for the FDA and that was very successful in educating and training a lot of surgeons that was the bulk training that we did. And then what we’ve done since then is kind of Phase II and we still do some of Phase I because there are surgeons that have not been to some of the courses they want just the refresher course. And so we still do host that, we just got fewer surgeons to go through that. Now we are very focused on Phase II and III, Phase II being the it’s a more advanced course than the first one it's about a day session and it's evening and then the next day they get into a much deeper content relative to how do you actually do the procedure they talk back and forth with the other surgeons who are doing the contaminant treatment and we've done I mentioned 80 through the end of last year we've actually had 140 accounts in total that have gone through that training since we started it. And as I mentioned on the last call we get about a 40% to 50% increase in volume from those sites coming off of the advanced courses so it's a very good course in terms of getting it to the surgeons to come out of their and actually begin practicing and using the products and treating patients, and…

Operator

Operator

The next question comes from the line of Mike Matson with Needham & Company. Please proceed.

Brad Mas

Analyst · Needham & Company. Please proceed.

Hi, guys. This is actually Brad in for Mike. Just going to take the other side of the first question international I know it's a smaller part of the business but it seems like it slowed a bit especially ablation just wondering what are your thoughts on that pegging back up in the back half of the year and then why just anymore color on Japan and Eastern Europe weakness?

Mike Carrel

Management

Yes so overall in the international basis like you said we saw some headwinds relative to foreign exchange we are 18% growth on a constant currency basis and we were obviously the currency had a large impact on getting us to closer to 3% to 4% growth rate on a GAAP basis so that was the major impact we did not and we anticipated not much more growth in that quite frankly if you remember our original guidance was 16% to 18% it was kind of at the high-end of our growth which is if the U.S. outperformed so strong that I think it had some sort of it had an impact on it from that standpoint. In terms of on the direct basis in Europe things are going incredibly well I feel very good about the countries that I talk about actually we have a direct presence in Japan there was currency components to it as well but we don't sell them in currency so we’re working through that on the Japanese front and we are getting new approvals for clip and other products here over the course of the next 18 months and even as this year kind of goes on and so we feel really good about kind of where we are on the Japanese market and what the numbers look like for the year. Eastern Europe that's a more that's a less predictable part of our business and we kind of put that into our numbers as we think through it quarter-to-quarter it's all the more difficult to predict we've got a good sense for the year is going to look like but in any given quarter each country is a little bit smaller of an impact and like you said you miss on one country and it can kind of have a small impact it was just a lot of countries missing by a very small dollar amount quite frankly and that's why as I mentioned we are pretty much in line with what we thought overall because we were so strong in the Western European countries.

Brad Mas

Analyst · Needham & Company. Please proceed.

And just wondering what are your thoughts on the recall, now some of the entire pool I mean obviously it can be looked at as a positive since it remained competitive for the clip but wondering do you think there is any negative impact or do you think that should help accelerate AtriClip?

Mike Carrel

Management

I mean it's always unfortunate when another company has to go through a recall you think about the patients and the impact that it must have had and the tough decisions that a company has to go through on that front, so from my standpoint there is not a positive or negative to our business per se and I'm out in the marketplace we’re continuing we know that our part is safe effective we've got 50,000 of them that are out there in the field today and so we really continue to sell and focus on really the positives about what we've got within our product as opposed to on the competition on that front.

Operator

Operator

The next question comes from the line of Tom Gunderson with Piper Jaffray. Please proceed.

Tom Gunderson

Analyst · Piper Jaffray. Please proceed.

So, Andy just a quick clarification I don't know there was some interference when you said U.S. clip sales where they $5.5 million and a 52% increase?

Andy Wade

Management

That's right Tom.

Tom Gunderson

Analyst · Piper Jaffray. Please proceed.

Okay. Just want to make sure I got that. And then Mike the stroke trial do you want to hazard a guess or a range of times as to when you think the protocol IDE will be accepted part A and part B as you continue to talk with the FDA and even to some extent the KOLs but more the FDA do you get a sense if they understand difficulties and enrollment that you might encounter with a controlled trial and are they easing up on some things that might make that enrollment easier for you?

Mike Carrel

Management

Yes I think I wish I could answer you right now because I think it’s to be told in terms of the conversations they’ve been very welcoming the FDA in terms of the conversations. For us we’re trying to assess with the Watchmen being approved and with the guidance they had given us before to really kind of do a randomized trial against Aspirin. Where are we today in those conversations and like you said enrollment would be difficult likely on the latter one. And so we’re trying to figure out what’s the net benefit to us and on what label are we actually going after. We sell the product today and obviously we’re doing very well in that front so we want to be very careful not to impact the positive franchise that we have today. We have got product that’s out there, it’s helping patients worldwide in managing the appendage. We want to do something that is going to benefit even more patients. So we’re being very careful in terms of the best way to approach it. We’re not in a rush. We’re not going to just try to get a trial out there. And so again we have been very open to dialog but I don’t know that we’ve gotten great we’re not the point of having pure guidance. If I hazard a guess we’d like to have some decisions on this and finalize kind of what our strategy is by sometime in the back half of the year and again it doesn’t really have an impact on our revenue, or our growth over the next several years. It’s really a long-term plan. So we’re going to take our time but likely it’d be back half of the year.

Operator

Operator

The next question comes from the line of Rick Wise with Stifel. Please proceed.

Drew Ranieri

Analyst · Stifel. Please proceed.

Hi guys. It’s Drew Ranieri here for Rick. Thanks for taking the question. You’ve given this in the past, but can you quantify how many clinicians you’ve trained in the U.S. and maybe how much you have left to do?

Mike Carrel

Management

The number we’ve always quoted is 1,600, and really that is not focused on the training in the U.S. on that on the numbers basis anymore because that we’ve kind of gone through and actually met all the obligations we have with the FDA and that was really why that number was important we had to make sure all the accounts were trained. We are now selling to over 870 customers bought product from us in 2014 and that’s up from 670 accounts several years earlier. And so we’ve obviously seen some uptick based on some of the things that we’re doing out there but from a training standpoint it’s really difficult to kind of say how many more we have to get done necessarily it’s really more focused on the advanced training, on-site training that I talked about earlier.

Drew Ranieri

Analyst · Stifel. Please proceed.

And then you mentioned two new products a year for launching, but can you give us anymore color about what areas we might be able to or what areas you might be launching them is it probe is it MIS?

Mike Carrel

Management

Yes and yes, we’re really focused on Clip, CRYO, RF all aspects of that our research team is -- we have added a lot of talent there and fire power quite frankly in terms of getting product out the door. You saw some of the work we did on CRYO it isn’t easy it wasn’t just the label, there is an approach to that and we’ve got other products that we’re going to continue again. It will hit on all aspects of our business. Anything we can be doing to kind of create better legions, make things more minimally invasive, that’s really kind of the focus that we’ve got for all of our product lines right now.

Operator

Operator

The next question comes from the line of Charley Jones with Markets. Please proceed.

Charley Jones

Analyst · Markets. Please proceed.

I guess I want to start with the Clip I was curious if you could give us a little bit of detail around the open-clip, seeing 41% is pretty good given 20% growth in ablation 26 in the U.S. are you pretty fully penetrated in your own procedures I know you’re starting to really get some traction at the non-AF cases are you really taking share from Medtronic and I guess I was hoping you can make some comments may be around market growth in the U.S. and internationally may be to pick up the other half of Tom’s question?

Mike Carrel

Management

Yes. As it relates to the growth of the Clip kind of being a faster growth rate I just think you’ve got more customers that are beginning to use it now. And not all customers are using it and they’ve been doing ablation before now they’re doing that. So we just seeing more and more sites kind of pick it up that were not necessarily using the Clip before. So that’s been really kind of more extraordinary than anything else. And we do have some people doing concomitantly with some other non-AF procedures I am starting to see some of that in terms of just discussion it’s obviously one of the reasons why we’re doing the ATLAS trial was to actually test that theory out and so we’ve got some growth associated that. So that’s really why you’re seeing it just more accounts buying from us and those accounts that are buying from us are actually doing it on more and more cases. And so I think that’s really driving most of that growth from that standpoint. In addition to that there has been questions on our calls before around the MDRs and AVRs and CABGs and this as AVR and CABG kind of concomitant treatment grows which we believe that it is you’re starting to get more clips on those cases as well because sometimes on the micro valve we’ll just cut and sell it themselves as opposed to putting a clip on. But that’s what’s really driving the faster growth on the Clip side than anything else. And then I didn’t completely understand the second part of that question.

Charley Jones

Analyst · Markets. Please proceed.

The market growth for your open ablation business, if you’re growing the U.S. 26% where is Medtronic versus market growth?

Mike Carrel

Management

It’s really difficult for us to know Medtronic obviously has their numbers within a very-very large organization it’s more difficult for us to kind of capture that data. We’re really focused on kind of penetrating within the accounts that we’ve got today and creating sticky revenue from that standpoint and getting them quite frankly just to treat more patients. So we’re more focused on just growing the market overall we grew 19% open in the U.S. we’ve talked about that before that 15% plus number on the open side we see that kind of going for several years. But we don’t know exactly we have to ask me in six months what the growth rate was because then we will have the data from STS to kind of see it. But I can’t know within the individual quarter per se.

Charley Jones

Analyst · Markets. Please proceed.

And then it kind of leads to my next question, I think you’re talking with Danielle back in February about the STS considering a recommendation change from 1B to a 1A. Have you learned anything more about that process and can you talk to us a little bit about that and whether or not you think that enables maybe an acceleration of growth in your open business, maybe not 26% but from your guidance of 15%?

Mike Carrel

Management

You’re correct. Back in the -- at STS back in January, the committee that was focused on this did make a recommendation to the broader STS population and membership and we’re still waiting to hear if they’ve accepted that, hopefully they will. It can take anywhere from three to 12 months for those types of votes to kind of go through. I haven’t heard anything to the negative on it so I am not sure that I would hear. But the good news there has been a recommendation that’s been made and as soon as that information comes out I am sure we’ll all probably see it, whether it’s in different press releases and news from the STS. But yes I do believe once that comes out it won’t have an immediate impact that day if you want to initially going to go start to do the procedure. But I think that cumulatively as more and more good data comes out like that it’s going to have a positive impact on the open growth.

Operator

Operator

There are no further questions in queue at this time. I would now like to turn the call back over to Mike Carrel for closing remarks.