Earnings Labs

AtriCure, Inc. (ATRC)

Q2 2010 Earnings Call· Wed, Aug 4, 2010

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Transcript

Operator

Operator

Good morning and welcome to AtriCure second quarter 2010 earnings conference call. My name is Kathlyn 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. (Operator Instructions) And I would now like to turn the call over to Mr. David Drachman, President and Chief Executive Officer of AtriCure. Mr. Drachman, please proceed.

David Drachman

Management

Thank you, Kathlyn. Good afternoon and welcome to our first quarter earnings conference call. Joining me on the call today is Julie Piton, Vice President of Finance and Administration and Chief Financial Officer. At this time, I would like to turn the call over to Julie for a few introductory comments.

Julie Piton

Management

Thank you, Dave and good morning, everyone. By now you should have received a copy of the second quarter earnings press release. If you have not received a copy, please call Sarah Luken [ph] at 513-755-4136 and she will fax or email you a copy. Before we begin, let me remind you that the company's remarks today may include forward-looking statements. These statements include but are not limited to those that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as revenue and earnings estimates, other predictions of financial performance, launches of new products and market acceptance of new products. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control, including but not limited to the rate and degree of market acceptance of AtriCure's products, governmental approvals and other 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. And AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additionally, we will refer to non-GAAP financial metrics in the call today. A reconciliation of these non-GAAP measures is included in our press release, which is also available on our website. I would like to remind everyone on the call today that the Food and Drug Administration, or FDA has not cleared our products for the treatment of atrial fibrillation or AF or for stroke reduction. The company and others acting on its behalf may not promote any of its products for the surgical treatment of AF or train doctors to use the products for the surgical treatment of AF. These restrictions, however, do prevent doctors from choosing to use the products with the treatment of AF for stroke reduction or prevent AtriCure from engaging in sales and marketing efforts that focus only on the general attributes of the products for the current cleared uses. AtriCure has provided research grants to institutions for the purposes of conducting certain studies that may be referred to on this call. The primary authors of the papers referred to on this call may be consultants to AtriCure. With that, I would like to turn the call back to Dave.

David Drachman

Management

Thank you, Julie and welcome to members of the investment community who have joined us today for our second quarter earnings call. We’ve been highly productive during the past three months. Business is strengthening and we have made significant progress with FDA on several critical projects. We’re moving full speed ahead with our strategic plan. We will begin with opening remarks and a brief summary of our second quarter financial performance. Then we will review our AtriCure platform and opportunity. Next time, we will provide an update regarding regulatory clinical reimbursement and product pipeline initiatives. Following my remarks, Julie will present a detail review of our financial performance. I will then comment on our outlook and open the call up for questions. All med tech companies are currently facing uncertainties associated with an intending healthcare reform, more challenging FDA enforcement and approvals and broad economic uncertainty. Despite these circumstances, the global demand for cardiac medical devices is extremely strong which can be partially explained by the fact that people are living longer. According to a survey of 450 U.S. hospitals from the Marwood Advisory Group, hospitals are focused on growing cardiovascular and orthopedic procedure volumes and in effort to increase revenue over the next three years by capitalizing earnings trend. This survey also indicates that the devices to treat cardiac arrhythmias are not a target for hospital cost-cutting programs and that evidence-based medicine and peer-review literature will become more integrated into purchasing decisions. We expect that these trends will benefit AtriCure and like companies that provide physicians and patients with cost effective treatments supported with convincing clinical silence. Further, it is well established that there is a large and growing demand for effective atrial fibrillation treatment alternatives and safer and more effective message to exclude the left atrial appendage. We…

Julie Piton

Management

Thank you, Dave. I will begin by providing information related to revenue. For the second quarter of 2010, total revenue increased 3%, or 3.8% on a constant currency basis, to $14.2 million. Revenue from domestic sales grew 5.5% to $11.8 million. Revenue from domestic open heart products increased 4.7% to $7.6 million, driven primarily by an increase in sales of our disposable cryo probe. Minimally invasive domestic revenue grew 7% to $4.3 million, driven primarily by procedural growth. International revenue was $2.3 million and included a non-recurring negative impact of approximately $400,000 that resulted from transitioning a large European market from a stocking distributor model to direct AtriCure representation. This transition allows us to be more competitive in the territory and will benefit future periods. The reduction in international revenue was 4% on a currency-neutral basis, compared to 8% on a GAAP basis. As a reminder, revenue from our multifunctional pen which are used in both open and minimally invasive procedures is allocated between open and minimally invasive product revenue, based on our best estimate of the pen's actual usage. Additionally, domestic revenue from our AtriClip System is included in open heart product revenue. The AtriClip System was released on a limited basis in the United States at the end of June and contributed less than $100,000 in domestic revenue during the period. Now, turning to gross margin. Gross margin for the second quarter of 2010 was 79.1%, as compared with 77.4% for the second quarter of 2009. The expansion in gross margin was a result of an increased mix of domestic revenue and a reduction in product cost, driven primarily by manufacturing efficiencies. These increases were partially offset by an increased mix of newer products such as our disposable cryo probe, which carries a lower gross margin than our…

David Drachman

Management

Thank you, Julie. In terms of our outlook, we believe that the men and women of AtriCure are well-positioned to capitalize on our current momentum. The U.S. launch of our AtriClip System, further cryo and open heart market share gains, new product introductions and the continued expansion of our international markets, combined with further investments in sales and marketing, are expected to fuel momentum during the second half of 2010 and throughout 2011. Further, we believe that the growing demand for effective alternative procedures for persistent and failed catheter ablation patients will fuel the demand for our minimally invasive products. In addition, we remain committed to clinical science in atrial fibrillation approvals. We believe that our commitment and strategic investments in clinical science, atrial fibrillation approvals and innovation will provide the foundation for long-term sustained high growth. We will now open the call up for your questions.

Operator

Operator

(Operator Instructions) Your first question comes from the line of Charley Jones of Barrington Research. Please proceed. Charley Jones – Barrington Research: Hi good morning. Thanks a lot for taking my questions. Congratulations on a great quarter.

David Drachman

Management

Hi Charley.

Julie Piton

Management

Thank you, Charley. Charley Jones – Barrington Research: I was wondering if you could give us an idea of what you are expecting from international in the second half of the year, Dave? Or maybe, if the third quarter is still a little tenuous what you think this business can do kind of in the fourth quarter going forward?

David Drachman

Management

Well, we've added people in the EU. The EU remains our highest area for growth outside the U.S... We have more direct markets now and we are more competitive based on an expanded sales and marketing platform. So, we would anticipate that the international growth would be consistent with previous years. So we remain confident that the international markets are high growth markets for AtriCure, moving forward. Charley Jones – Barrington Research: And Julie, can you tell us whether or not current R&D levels can be maintained for a couple of quarters until full pivotal trial for the hybrid approach starts, or you are going to have to start making some investments here in the next couple of quarters?

Julie Piton

Management

Yes. We do not expect R&D expenditures to be consistent with second quarter. Second quarter was uncharacteristically light and we do expect a ramp in that category for both the third and fourth quarters as well as moving into 2011. Charley Jones – Barrington Research: Can you talk a little bit about the need for sales force expansion, Dave, and how many reps you think it takes? I guess I am particularly interested in how you plan to approach the hospitals for getting the new device approved for purchase and whether or not it just requires a short-term bolus of people and then you can cut that back and how you plan to deal with that?

David Drachman

Management

Well, first of all, we've built our U.S. sales organization up to 55 headcount. Last year, at one point in time, we dipped under 50. So, we have added people in the U.S., we are currently interviewing for expansion territories. In terms of the product and the time that it takes to get new products into hospitals, there is no question that the Value Analysis Committees have lengthened the period of time that it takes to get new products stocked in the hospitals. So, currently we think that we are scaled properly given our revenue trends. We want to align costs with revenue and, as we continue to get new products into hospitals, we will continue to look at expansion territories. I would anticipate that we will see two to three expanded territories by year end. Charley Jones – Barrington Research: So, I guess, with that, Julie, do you think you can remain cash flow positive for the foreseeable future since you probably won't have inventory built until you really start to see higher revenue levels or …

Julie Piton

Management

In terms of cash flow positive, are you referring to cash from operations? Charley Jones – Barrington Research: Yes.

Julie Piton

Management

Okay. I would expect our overall cash from operations to be slightly more than prior year really in support of working capital needs to support the growth in the business and combined with the fact that we closed up 2009 with relatively light inventory levels. And so, I think you will see a modest increase in our cash used in operations year-over-year. Charley Jones – Barrington Research: Okay. And then, Dave, I was hoping you could discuss a little bit more detail about your pricing strategy for the clip and then both the different delivery mechanisms?

David Drachman

Management

Well, first of all, our pricing strategy is – we have a premium product. We believe our product offers unique advantages over the current surgical techniques and methods for excluding left atrial appendage. And we plan to stay the course in terms of pricing. Our current pricing has actually exceeded our expectation somewhat. It's early to tell whether or not that will settle in, in terms of pricing that approaches $1000 per unit. But we are currently encouraged by the fact that physicians have given us very high marks for the AtriClip System. And our people are working to get initial orders and then are working with the Value Analysis Committees and purchasing departments to get our products stocked on the shelf. We sold the product into about 40 accounts and about 20 of those accounts are now stocking the product and that's with, as you know, a July launch. In terms of the different deployment tools, moving forward we see the open heart deployment tool being the main product that we sell. This gives the surgeon certain advantages in terms of access. We continue to improve our minimally invasive and thoracoscopic products. And we have plans to expand into a new platform for thoracoscopic and robotic use during 2011. Charley Jones – Barrington Research: And I was wondering if you could, I guess, give us a range on what you expect that next generation device to sell for if you are not ready to do that yet?

David Drachman

Management

I think it's a little early in the game in terms of the minimally invasive thoracoscopic standalone products how we'll price that. I think we need to see how the open heart product settles in, what our pathway is in terms of stocking the products and then we will conclude and make those decisions. Charley Jones – Barrington Research: My last question, and I was hoping you could update us on number of minimally invasive U.S. centers and maybe give us the international as well? And then, finally, I think you have a little over 700 total U.S. accounts. What percentage of these do you think will end up adopting the clip over time, or maybe over the next 12 months?

David Drachman

Management

Okay. So, first question is minimally invasive accounts. Approximately 65 accounts purchased minimally invasive products in the U.S. during the first quarter. We have approximately 20 minimally invasive accounts in our international markets that routinely perform minimally invasive procedures. In terms of the accounts on an annual basis, we would anticipate that approximately 50% of our accounts over the next 18 months will adopt our AtriClip System. Charley Jones – Barrington Research: Great. Thanks for all the questions.

Julie Piton

Management

Thanks Charley.

Operator

Operator

Your next question comes from the line of Jason Mills of Canaccord Genuity. Please proceed. Jason Mills – Canaccord Genuity: Hi Dave, hi Julie. Congrats on a good quarter.

David Drachman

Management

Hi Jason.

Julie Piton

Management

Thank you Jason. Jason Mills – Canaccord Genuity: Good. Thanks for taking the question. First question, little bit more 20,000 feet Dave, last year, clearly the industry, the afibrillations, procedures were somewhat sluggish. I am wondering what you are seeing here as you seemingly turn the corner midyear into the back half of the year in terms of procedures and what you guys can do to help sort of instigate growth overall in the numbers of ablations in the U.S. specifically?

David Drachman

Management

Excellent questions. In terms of the overall number of surgical procedures, there has been a modest growth in the open heart area. We think it's in the low-single digits. As you know, there has been some consolidation of vendors and sales forces. Our growth is coming from market share gains. The stimulus that we believe will really grow the open heart market is an AF labeling approval. We think the ability to market to cardiologists, to market to cardiac surgeons, to market to patients. We think that ability to really have a broad marketing platform for AF therapy and to have affirmation through an FDA approval is the catalyst that we need to really see significant growth in the open heart market. We also think that the clip will stimulate growth. We believe that getting the clip out to the marketplace will make people reconsider treatment of surgical ablation patients whether they do the entire ablation or just place the clip. We believe that's also a significant opportunity to stimulate some growth in the marketplace. Jason Mills – Canaccord Genuity: And with respect to the clip, it's early and you are in a relatively small number of accounts now. But, in our due diligence, we've received some pretty good feedback with respect to the device. I am wondering, with the new deployment system and the expanded sales force, you said 50% of accounts will adopt AtriClip over time. I am wondering what sort of the tenor of that adoption curve will be in terms – as you see adoption will we see a hockey stick at some point, a tipping point at some point and how long will it take to get to that 50% of accounts do you think?

David Drachman

Management

I think the 50% of account penetration – we'll say it's an 18-month process in terms of the total AtriCure account. Jason Mills – Canaccord Genuity: Okay.

David Drachman

Management

I think in terms of the tipping point, as people begin to buy and purchase and stock, the AtriClip System, what we believe we are going to see is more and more continued usage. I think certain surgeons will adopt the AtriClip System for certain limited usage and we believe that those – the utilization in the clip will be used more frequently in the accounts that purchase it. I think once the surgeon gets comfortable with the first series of implants and sees how simple and effective the clip is, they'll be encouraged to use it more frequently. So to answer your question, I think the product platform does have the ability to create the tipping point or hockey stick. But I think we are 6 to 12 months away from seeing that. Jason Mills – Canaccord Genuity: Okay. Great. And I'm sure you've seen, maybe not gone through it all, but the CDRH preliminary internal evaluation from the 510(k) working group came out last night, just the preliminary report and recommendations. And in it there were several things, but clearly they are trying to streamline the 510(k) process and make it more visible, more certain for both companies and the internal reviewers. One thing they talk about is more rigorous characterization of predicate devices, et cetera. The information you gave us today on the ABLATE trial is positive in my view. I am wondering if you have any knowledge as to whether or not the FDA, in developing the agreements you talk about, consulted some of the preliminary findings that were written in this preliminary report. In other words, is there is a possibility that vis-a-vis adoption of this preliminary report that there would be any change to the current trend that you've discussed today as it relates to ABLATE and the AF indication?

David Drachman

Management

We feel very positive. We've had two in-person meetings, one was just a few week ago. The entire review team was in both meetings, as well as the Director of Cardiovascular Devices who really led the meeting. The fact that the Director of Cardiovascular Devices has taken an interest in our submission and participated in the discussions, in terms of how we can answer FDA's questions and come up with a plan for product approval, we thought that was very encouraging. And we are very interactive with FDA right now. In fact, we are talking with FDA on a weekly basis in terms of our registries and certain aspects of our submission. So, it's become a very interactive process. I think that the information that we provided today is very solid. Jason Mills – Canaccord Genuity: Okay. Great. Two quick final ones and I'll get back in queue. With respect to your number of minimally invasive centers, have you seen that number moderate a bit in the last couple of years? The number we have in our head is sort of – it was at its peak up in the 70, 80, 90 range. Forgive me if I am wrong and you can correct me, now you are coming – about a number a little bit lower than that. Maybe you could just give us some color on that and as well as plans you have to ramp the number of MIS centers back up? And I have one final follow up and I'll get back in queue.

David Drachman

Management

That's an excellent question and you are correct. Fundamentally, our 55 sales people have been highly focused on cryo, penetrating the open market, now the AtriClip launch and getting our DEEP AF clinical trial up and running. We have focused on developing more volume in the centers that have really adopted this procedure as a standard of care. So, procedures on both a sequential basis and a year-over-year basis are up. However, we are performing more procedures in fewer centers. I think the catalyst to further expansion is, once we have our DEEP trial up and running, we have our clip launch and we begin to generate continued revenue growth. We have plans to expand our sales organization and have more people that are focused on our minimally invasive business. And I think those are the key characteristics that will expand the base of accounts that are performing in minus. Jason Mills – Canaccord Genuity: That's very helpful. One last follow up is, out of positive things to be talked about today, and you seemed very bullish about where the company stands and your developments and potential going forward. I am wondering if you could take a step back and help us understand so that we don't get too far ahead of our sales in terms of modeling the business. Sort of what challenges that AtriCure faces over the next 6 to 12 months that we should be cognizant of so as to make sure that we are not getting overly aggressive with any of our numbers.

David Drachman

Management

I think some of the challenges that we face is AtriCure is a very busy company. We have two clinical trials underway. The ABLATE clinical trial, although the primary analysis is going to be used from a PMA perspective, we are running ABLATE registries that will be used as an amendment prior to our panel meeting. We are also getting a DEEP AF trial up and running in the U.S. which takes a lot of effort. We have five new products that we are planning to bring to market. So, I think some of the challenges that we have is the company has a lot of activity for a relatively small company and the AF space is a complicated space and working on AF approvals is certainly not a simple process knowing that only one product, the ThermoCool catheters, ever received an AF approval. So, I think those are some of the challenges. The fact that the company is busy in terms of clinical science, in terms of innovations of new products and we are managing that in terms of our internal structure, we are managing those activities very nicely in terms of the operational performance, while we look to increase our financial performance. Jason Mills – Canaccord Genuity: So, the last one and I will get back in queue. So that would imply that we should be careful, to Julie's earlier comment, to model sort of an increasing level of cash flow from operations or EBITDA at least for the next, call it, two to four quarters. Is that an accurate assessment?

David Drachman

Management

I think it is Jason. We believe we have the necessary capital on hand in terms of again to invest in our strategic priorities. However, I do think that your analysis is correct in terms of how you would view the business over the next several years in terms of our capital structure. Jason Mills – Canaccord Genuity: Okay. Thanks guys.

David Drachman

Management

Thank you.

Operator

Operator

Your next question comes from the line of Tim Lee of Piper Jaffray. Please proceed. Tim Lee – Piper Jaffray: Hi. Good morning and thanks for taking the question here.

David Drachman

Management

Hi Tim. Time Lee; Just, first on the AtriClip side, I appreciate the kind of the market opportunity that you laid out here for us. How should we think about it from a revenue contribution standpoint here for the back half of '10 and heading into '11. What type of market penetration do you expect to see, call it, 12 to 24 months out?

David Drachman

Management

I think we are certainly going to go to our top 100 accounts. So, when we talk about 10,000 procedures and combining the clip in the AtriCure ablation procedures. I think that's the most rapid growth opportunity we have. And then, penetrating the other say 400 or 500 accounts that purchase AtriCure products, that will be a relatively slower process. The one thing that we have to evaluate is the market for new products in terms of the purchasing departments and these Value Analysis Committees has become more challenging. So in terms of the ramp of the clip, the physician feedback is extremely positive but the process of getting the clip on the shelf and stock is not a simple process and it's a time consuming one. So, we'd rather be out another quarter or two and give you more color on the revenue ramp once we get a better sense of really how long it's going to take to get the product stocked. Tim Lee – Piper Jaffray: Got it, fair enough. And then, just kind of on the gross margin line, was there any impact from the European transition from going from a distribution to a direct model in that one market and was there any cost tied to taking back inventory or anything on that front that impacted your gross margin?

Julie Piton

Management

Yes. That was just a small impact. So, the transition is actually effective at the beginning of July but we negotiated the contract, since we knew we would have the returns, Tim. It was a small impact associated with those returns as well as we didn't benefit from the stocking order during that period. So, those are the two components that drove to the combined impact of $400,000 U.S. in the quarter. Tim Lee – Piper Jaffray: Got it, thanks. And then, just again staying on the P&L front here, your operating loss this quarter was much lower than we had expected and it sounds like some of the expenses are kicking back up here in the second half, as gross margins are coming down. So, we should expect to see operating losses at least for the near term kind of go back up, I mean, directionally. I mean, I assuming that would be the right way to think about it. So when could we expect to see – given such strong performance you had here on the operating line, when could we see a similar type of losses? Is that 12 months away, is that 24 months away, when can we get back to this level?

Julie Piton

Management

Yes. Why don't we stick with operating expenses since the loss is obviously driven by revenue and gross profits? So, in terms of operating expenses, I would anticipate an increase in the research and development line to get back to more sort of historical normalized levels and probably sustain there for the back end of the year and then some increasing growth during 2011. And with respect to SG&A, I think you will see modest increases in that line really due to some incremental heads that we will add, as Dave commented, from splitting the territories. Tim Lee – Piper Jaffray: Got it. And then just one last one, again, I am trying to see if you would back into kind of a top line guidance. I know you used to – in the past, you had given some reference to kind of your top line goals. I know you would pull back on that just given some uncertainty in the market and some of the uncertain dynamics the company was facing. But with a lot of that kind of behind you now, do you have much better visibility on your top line opportunities to provide us with some of the targets that you are looking for?

David Drachman

Management

We are going to reevaluate the guidance Tim come 2011. Right now, we are in the process of launching what we think is a growth catalyst in the AtriClip System. We are in the process, again, of splitting territories and adding some sales people. So, for the remainder of the year, we like to stay quiet in terms of revenue guidance. Tim Lee – Piper Jaffray: Thank you. I will get back in line.

Julie Piton

Management

Thank you, Tim.

Operator

Operator

Your next question comes from the line of Vivian Cervantes of Maxim Group. Please proceed. Vivian Cervantes – Maxim Group: Hi. Thank you taking the question and congratulations on a good quarter.

David Drachman

Management

Thank you, Vivian.

Julie Piton

Management

Thanks. Vivian Cervantes – Maxim Group: I appreciate your comments on market share gains in U.S. open, it looks particularly in cryo. Any sense on how sustainable that is given, consolidation gyrations on the competitor front. And, I guess, I also appreciate comments on new product in the cryo space. How can you sort of balance those two out together?

David Drachman

Management

Well, we think the penetration that we are seeing and the increased market share gains that we are seeing on the open market are sustainable in part because, for example, we have a new cryo platform or a next generation product that we are going to launch this year. We talked about the new generator which puts the controls in the surgeon's hands, and a new probe that is much more ergonomic, in the first half of 2011. So, we are developing our cryo platform. We think that we can continue to take more market share on the cryo front and we have the AtriClip system which is going to open new doors for the company and allow us to have some cross selling opportunities for ablation device. So, in terms of penetration into the open market, we continue to see similar share gains going forward. Vivian Cervantes – Maxim Group: Okay. That's helpful. Can you sort of help quantify what the gross margin impact or list would be from the distributor consolidation in Europe?

Julie Piton

Management

Right. So, for that territory specifically, we would expect an uptick to revenues of approximately 30% which would equate to roughly a 15% uptick in gross margins for that territory. Vivian Cervantes – Maxim Group: Okay. And then, Julie, in your prepared remarks you had made comments about noting some pricing pressure in Europe and maybe increased competition and maybe some impact on reimbursement. Can you elaborate on that a little bit and maybe give a sense on whether or not this is like a low single-digit pressure, high single-digit pressure, any color would be helpful?

David Drachman

Management

There is pressure in the European markets, however, there is significant opportunity. Our market share in the European markets, as you know, is significantly lower than our market share in the U.S. So, even though we are encountering pricing pressure, we have the widest range of products and technologies. We are bundling those products in certain markets and then we are increasing our direct sales force. So, going direct in this larger European area, being direct in Germany, we basically doubled our sales force head count over the last 12 months in the European markets. So we continue to see strong growth in international largely, driven by the European markets, independent of the pricing pressures and some of the economic uncertainties. Vivian Cervantes – Maxim Group: Okay. Very helpful. Thank you.

Julie Piton

Management

Thank you, Vivian.

Operator

Operator

Your next question comes from the line of Matt Dolan of Roth Capital. Please proceed. Matt Dolan – Roth Capital: Yes. Good morning. Wanted to look at the clip in one other way here. Dave, can you tell us what percent of your current open procedure volume involves the exclusion of the appendage with staples at this point and assumedly would this cohort likely all shift to the AtriClip?

David Drachman

Management

Matt, I'd rather just say generically taking the appendage, giving you color on staples versus sutures, I am not confident in trying to break that down, but there is about 80% of the procedures that we perform, there is a left atrial appendage exclusion involved. Matt Dolan – Roth Capital: Okay. Great. That's helpful. And then shifting to the MIS piece, in particular the hybrid program, can you give us the number of centers now with hybrid capability, today, in terms of volume? I know in Q1 you saw some softness in the MIS business as some of these accounts shifted to hybrid. So do you feel like the second quarter was more normalized or are there are still some accounts that are in transition so to speak?

David Drachman

Management

There are certainly accounts in transition. We're really trying to focus on getting the DEEP AF clinical trial up and running. Our major aim is to get the first 30 patients enrolled, get into 2011 and submit an interim analysis that would allow us to move into a pivotal trial of approximately $0.30. We think generating that sort of momentum through an FDA regulated process will draw physicians to adopt minimally invasive and hybrid procedures more readily. So we're going to focus more on the FDA process in doing what it takes to get the DEEP AF clinical trial into a pivotal phase. Matt Dolan – Roth Capital: Okay. And then in terms of your growth outlook for the rest of the year, I think in the past you've talked about better growth in the second half of 2010 relative to the rates we've seen thus far. And I believe that was excluding or that was prior to the clip's approval at least. So the underlying assumption looks like you would return to the double digits in the base business, excluding new products. Is that a fair assessment at this point?

David Drachman

Management

That's an aim. And I will say that when we talked about a stronger second half, remember the clip was on and off. We originally projected the clip to be approved around midyear and then we had a snag with the FDA in terms of some of the preclinical data in the GLP studies that we talked about on our previous earnings call and that information came right upon us right before the earnings call. So we originally were talking about stronger momentum in the second half of the year. We were thinking that the clip was going to be part of that process. And then several days before our past earnings call, we got news that we may have a delay with the clip. So we have been thinking about the clip as part of the second half of the year story in terms of stronger growth. We also believe that there is growth coming from the international markets and continued penetration with our cryo system and we believe the minimally invasive – that the foundation for minimally invasive is strong and will get stronger especially as the DEEP AF clinical trial gets up and running. Matt Dolan – Roth Capital: Okay.

Julie Piton

Management

I would just add to that Matt, as you think about the back-end of the year, just as a reminder, obviously our third quarter we do realize seasonality also. So we would expect that to have an impact on the base business for the third quarter results. Matt Dolan – Roth Capital: Sure. Okay. Thanks guys.

Julie Piton

Management

Thank you.

Operator

Operator

Comes from the line of Charley Jones of Barrington Research. Please proceed. Charley Jones – Barrington Research: Thanks for taking the follow-ups here. I was hoping you could start with the robotic discussion. I think your products are already able to be used with daVinci. So I was hoping you could talk to us a little bit about what kind of enhancements you're planning to make and whether or not there are certain products that can be used and maybe just a little more discussion around that?

David Drachman

Management

Actually our products are not robotic compatible today. There are certain ways to use our cryo platform robotically, but it's not generally designed for robotic use. If you look at some of the newer platforms that we plan to be robotic compatible, the clip, we can simplify the clip very easily in terms of stripping down the deployment system and have a very simple approach to a robotic solution for the clip. And we have also plans for our cryo probe where we can also strip back some of the – robotic handling of the cryo probe. So the handle in some of the components that are currently on the cryo probe actually stripping it down will make it more robotic compatible. So the robotics and getting to robotic platforms actually is not a significant engineering challenge. Basically, what we are doing is taking more products away in terms of things like the deployment tool on the cryo, taking the handle away and making it again more simplified and more robotic compatible. Charley Jones – Barrington Research: It sounds like the clip changes are pretty minor. Do you think you could have that commercialized earlier than 2012? And if so, what would be kind of your best guess there?

David Drachman

Management

I think we can have a product ready for human use by year-end. However, the current indication is for concomitant open heart under direct visualization. So we would anticipate having a product available for human use by year-end and then working with FDA to understand what the process is to get the product on the market. Based on our current discussions with FDA, we would anticipate a clinical trial similar to the EXCLUDE clinical trial that would be necessary for clearance for the robotic and thoracoscopic compatible clip system. Charley Jones – Barrington Research: Now, would that be a standalone clip procedure or would that be still concomitant with an AF procedure using the robot or thoracoscopic approach?

David Drachman

Management

Currently, we are thinking concomitant. However, we have a large group of surgeons that believe that there is a significant opportunity for a standalone robotic clip. Charley Jones – Barrington Research: That was actually one of my follow-up questions. I guess I don't understand why you are not planning on filing an IDE pretty quickly for a minimally invasive standalone clip procedure to show some stroke reductions so you can get a standalone code here?

David Drachman

Management

Well, we think the quicker route to market is a concomitant route. So our current plans are to file an IDE for a concomitant robotic compatible AtriClip System. Charley Jones – Barrington Research: Is there any talk about trying to obtain some additional reimbursement for the clip?

David Drachman

Management

There has … Charley Jones – Barrington Research: Or would that require that standalone sole procedure that we were talking about just a second ago?

David Drachman

Management

Well, first of all, if a surgeon performs a clip as a standalone procedure, they have the ability to use what's called an unlisted code. We've have a lot experience with unlisted codes. In 2007, CMS pulled back on reimbursement for AF ablation. So all AF ablation was basically reimbursed. Physician reimbursement was – they used an unlisted code and they cross walked that over to similar procedures with similar workload. So if people adopt a standalone robotic clip, they do have the option of documenting the clinical necessity and working with an unlisted code. In terms of having a unique code, one of the things that we've done is talk to STS. And they plan to sort of follow the endovascular devices and try to piggyback reimbursement onto the endovascular devices. Charley Jones – Barrington Research: Yes. On that topic, I was wondering – you obviously know a lot of EPs, some of them that maybe like minimally invasive, some that maybe don't. Of that second group, have you had discussions with EPs about using the clip in a standalone procedure, but concomitant with the catheter procedure?

David Drachman

Management

We've had discussions … Charley Jones – Barrington Research: Interest amongst EPs …

David Drachman

Management

We've had discussions with lots of EPs about doing a thoracoscopic procedure to exclude the left atrial appendage following a catheter ablation. So, for example, we have centers doing hybrid procedures in the electrophysiology lab. So we could envision, as we have thoracoscopic tools that are uniquely designed for left atrial appendage exclusion that EPs will perform catheter ablations and they might choose an epicardial approach or thoracoscopic approach versus an endovascular approach in the EP lab. Charley Jones – Barrington Research: Do you think there is high interest for that or it's still kind of early?

David Drachman

Management

I think it's early, but I do think that the interest is fairly high. I think physicians understand that not leaving something behind in a circulating blood pool, that performing an epicardial exclusion may be a preferred approach. Charley Jones – Barrington Research: My final question relates to ABLATE. I was wondering if you could tell us how many sites are going to be included in the registry, how those sites were picked. And then finally, are you able to give us an efficacy rate that you saw in the ABLATE clinical trials at six-month results? And that's it. Thanks a lot.

David Drachman

Management

First of all, in terms of the registry, a continued access protocol requires you to stay in the same sites that the original clinical trial was performed. So our continued access protocol will basically be in the same 10 centers that performed the ABLATE clinical trial. However, we have been working with FDA to expand that and sort of do another registry which would include a broader number of centers. So we actually plan to have two registries that are very similar in terms of the clinical protocol ongoing over the next several months, so two registries. The second registry will have new centers. How many new centers? We're currently discussing that with FDA now. In terms of the results, the results from the ABLATE clinical trial in the six-month analysis on permanent AF patients are in the high 70s. Charley Jones – Barrington Research: Okay. Thanks a lot.

Julie Piton

Management

Thank you. Operator, we will take one more call. Do you have somebody in queue?

Operator

Operator

Your next question comes from the line of Joanne Wuensch of BMO Capital Markets. Please proceed. Joanne Wuensch – BMO Capital Markets: Hi. Thank you so much for taking my question. When you were giving gross margin guidance, it was a relatively broad range. Can you help me understand what would lead you to the bottom of that range versus the top?

Julie Piton

Management

Sure. So this quarter Joanne, we had a higher mix of domestic revenues, which – there is actually a fairly large spread between domestic revenues and international revenues. So we talked about – we are optimistic about our opportunities for revenue during the second half of 2010. Additionally, the clip carried a lower gross margin currently than our existing disposable products. So to the extent revenue from the clip mixes in, I think you will see a little bit of impact on the margins. Incidentally, the 74% to 77% is what we have provided previously for our expected annual guidance. So I would think about the second quarter as a little bit of an anomaly for those reasons. Joanne Wuensch – BMO Capital Markets: Okay. Terrific. Thank you very much.

Julie Piton

Management

Thank you.

Operator

Operator

Ladies and gentlemen, this concludes the question-and-answer section of the call. I would now like to turn the call over to Mr. David Drachman for closing remarks.

David Drachman

Management

Thank you very much. We look forward to the third quarter earnings call and thanks for your time and attention.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Have a great day.