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AtriCure, Inc. (NASDAQ:ATRC)

Q3 2011 Earnings Conference Call

November 1, 2011 10:00 AM ET

Executives

David Drachman – President and CEO

Julie Piton – VP, Finance and Administration and CFO

Analysts

Jason Mills – Canaccord

Thomas Gunderson – Piper Jaffray

Charley Jones – Barrington Research

Larry Haimovitch – HMTC

Jose Haresco – JMP Securities

Operator

Good morning and welcome to AtriCure’s Third Quarter 2011 Earnings Conference Call. My name is (Francine) and I will be your coordinator for the call today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today’s call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.

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

Thank you, (Francine). Good morning and welcome to our third 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

Thank you, Dave, and good morning, everyone. By now, you should have received a copy of the earnings press release. If you have not received a copy, please call Sarah Luken at 513-304-8931 and she will be happy to fax or e-mail you a copy.

Before we begin today, let me remind you that the company’s remarks may include forward-looking statements. These statements include, but are not limited to those that address activity, 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, market acceptance of new products, and atrial fibrillation approval by the FDA.

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. A reconciliation of these non-GAAP measures is included in our press release, which is 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 referred to on this call also as AF or for stroke reduction. The company and others acting on its behalf may not promote any of its products or train doctors for the surgical treatment of AF or stroke reduction. These restrictions do not prevent doctors from choosing to use the products for the treatment of AF or stroke reduction or prevent AtriCure from engaging in sales and marketing efforts that focus on the general attributes of the products for the current cleared uses. AtriCure educates and trains doctors in the proper use of its products and related technologies.

With that, I would like to turn the call back to Dave.

David Drachman

Thank you, Julie. We will begin today’s call by reviewing the significance of the FDA advisory panels for recent recommendation for the approval of an AF indication for our Synergy Ablation System. Then we will review the clinical data from our ABLATE pivotal trial which is the basis for this approval. We anticipate final FDA approval during the first quarter of 2012. This positions AtriCure to be the first company to receive an indication for the surgical treatment of AF. Furthermore, this is the first approval for a persistent and longstanding persistent atrial fibrillation indication.

This approval signifies a major step forward for cardiac surgery and all interventional ablation treatments of atrial fibrillation. We appreciate FDA’s interactive and responsive review of the clinical evidence. Most importantly, an AF indication will allow us to thoroughly train surgeons which will optimize patient care and result in improvement patient outcomes. This anticipated FDA approval will mark a new era of the expansion in growth for AtriCure. FDA proposed indication is as follows. The AtriCure synergy Ablation System is intended to ablate cardiac tissue for the treatment of persistent for a long-standing persistent atrial fibrillation in patient to undergoing open concomitant coronary artery bypass grafting and/or valve replacement or repair. The advisory panel recommended that FDA approved the Synergy System to this indication.

The FDA approval will represent a path way to improve patient outcomes by enabling the company to perform comprehensive training and certified surgeons that demonstrate predefine measures of competency as AtriCure-qualified operators. Certified surgeons will have successfully completed the curriculum developing coordination within education steering committee comprised of physician experts in the interventional treatments of atrial fibrillation.

Now I would like to make three key points concerning the open concomitant AF ablation market first the large majority of cardiac surgery patients with preoperative AF or not receiving treatment for most recent market estimates if there are approximately 85,000 patients per year undergoing coronary artery bypass into a valve procedures with preoperative AF of these 85,000 patients approximately 25% are receiving concomitant ablation treatment today.

Secondly, preoperative as associated with the significant increase in debt and stroke in patients undergoing coronary artery bypass grafting and/or valve procedures the Cleveland Clinic publication of patients undergoing bypass procedures concluded there is more than 20% increase in mortality within 10 years and twice the number of strokes in patient with preoperative AF. Moreover (inaudible) study for Mayo Clinic found reduced late survival, more postoperative strokes as well as higher incidence heart failure in patients with preoperative AF.

A separate Mayo Clinic, macro valve study found in 18% difference in survival at 10 years and the 32% increase in late cardiac events and stroke in patient with postoperative AF. The primary conclusion of these three major publications is that patients undergoing coronary artery bypass grafting and/or valve replacement or repair with postoperative AF at increase late more ability and mortality.

The third point is the training and education is need to optimize patient care and improve patient outcomes. The 2007 HRS concerns the statement recommend that all patient with document AF referred for other cardiac surgeries undergo ablation procedure at next procedure at an experienced center unless (inaudible) significant risk. Please note that the key reference in this HRS recommendation is an experienced center. One condition FDA approval is requirement to initiatives of comprehensive surgeon training program the program curriculum has been submitted to FDA training and education will create more experienced center which will result improved patient outcomes and make safer and effective treatment more available to a broader population of patient that are indicated for concomitant surgical ablation procedures. To design we are developing an institute of surgeon training.

Furthermore we believe in AF indication will create a low effect for AtriClip system and that approval will be recognized by physicians as well as hospital administrators as an opportunity to use accurately label product in increase awareness with concomitant surgical AF treatments. Another condition FDA approval for AF level is supposed approval study we have been in the process of clabbering with FDA to design a post approval study.

We anticipate that the study will begin to update in criticize and include approximately 350 patients the aim of the study is to enrich the clinical science for open concomitant AF treatments and provide feedback on the effectiveness of our training program. We believe that executing our open concomitant strategy sets the foundation for sole therapy surgical approaches. We are currently investigating our products use to perform sole therapy hybrid ablation procedures in our FDA feasibility clinical trial.

Now review of the ABLATE clinical data which is foundation of our AF approval the primary safety outcome was a composite of major adverse events that consisted of debt stroke, TIA, myocardial infarction and bleeding within 30 days post procedures or prior to half flow discharge which ever was later. The ABLATE clinical trial in role patient which is wear structure heart disease and permanent atrial fibrillation that to find in the 2000 guide lines of the management of patients with AF, because the ABLATE patients were elderly, had significant left atrial enlargement, presented with a long history of permanent AF and heart failure the ABLATE study patient would have been highly unlikely to respond to capital for drug treatments importantly only one primary safety end point was associated with ablation producer and none of the primary safety end points were associated with a our synergy ablation system.

Despite the severity of the cardiac disease and the complexity of the primary surgical producers the ABLATE study in that this primary safety end point with the 9.1% rate of the primary safety end of this. In terms of the rate of pacemakers in ABLATE, the need for our pacemaker in the ABLATE population is linked to a long documented history of permanent AF. The patient normal rhythm is over written by DAF and often takes months to recover.

During this recovery period and implantable pacemaker maybe required. Importantly one of the patients the received pacemaker following surgery has been paced as last follow up. Once again importantly only one other patient that receive the pacemaker following surgery was being paced at the last follow up. In terms of efficacy the ABLATE clinical trial met the primary study end point at six month follow up 74% of patients were AF free and off anti-arrhythmic drugs. In addition 84% of patients were AF free at six months with the use of anti-arrhythmic drug. In conclusion the ABLATE trial met both primary safety and efficacy end points as agreed of time with FDA.

Now moving on to third quarter business trends, third quarter consolidated revenue of $15.2 million is a 5% increase compared to the same period a year ago. US revenue increased 2% to a $11.8 million driven by sales of the AtriClip system of 1.4% U.S. revenue from the sales of open ablation products increased mostly on a year–over–year compared basis.

We believe revenue from our open ablation products in the US was negative impacted by an estimated 10% reduction and primary open heart curial procedure during the quarter. We estimated that we have increased our open market share during 2011 and continued to strengthen our position as the market leader in this key segment of our business. US revenue is also reflects reduction in sale of product used (inaudible) way producers consistent with previously communicated expectations. As you recall, during 2010, we limited our training that FDA regulator trails which is temporarily impacted the physician adoption of our products using minimally invasive and hybrid procedures. We believe that revenue from products used in minimally invasive procedures will be relatively consistent ongoing basis.

However, we expect to return to growth with the commencement of our DEEP AF pivotal trial, which we anticipate initiating during the second half of 2012. Turning to our international markets, revenue from our international markets increase $3.5 million were 19% compared to the same period year ago. The economic conditions in Europe have not materially impacted our growth strategy, as majority of our business is in Northern European countries. We remain optimistic that are ability to sustain growth in Europe and Asia.

In addition, we are registering our products in Brazil and continuing to invest resources in geographic expansion. Turning to an update on product releases in pipeline, we receive (inaudible) clearance during the third quarter to enhancements that maybe Ice Box cryoablation generator more user friendly. As result this enhancements we are in the process of initiating the second manufacturing pilot in both US and Europe. We are targeting the first quarter of 2012 for first for full commercial release.

As you recall, Ice Box place the ablating controls with the position in simplify the use our cryoablation platform. We believe the Ice Box in combination with are currently marketed cryoablation pro will lead to share gains and growth in US and Europe. Furthermore, during the first half of 2012, we plan to release a new AtriCure platform. We believe that this innovation will be used in clinical trials and facilitate for long-term commercialization and widespread adoption of sole therapy epicardial left atrial appendage exclusion procedure developed for patients.

Who are contract indicated anti-coagulation drugs with respect to our plans for still clinical trial and support of the AtriClip system, submitted our IDE for feasibility throughout the FDA. The agency responded to the filing and we plan to resubmit an amended IDE during the fourth quarter.

At this time, I would like to turn the call over to Julie to detail overview of our financial performance.

Julie Piton

Thank you, Dave. I’ll begin by providing information related to revenue for the third quarter of 2011 which is seasonally impacted quarter revenue increased 5.2% to $15.2 million. Revenue from product sales as US grew 1.8% to $11.8 million. Revenue from relation related product sales decreased by approximately $150,000 in the US driven by the decrease in sales of product used in minimally invasive procedures.

This decrease was partially offset by modest increasing revenue from open-heart ablation products. US sales of the AtriClip system during the quarter were $1.4 million as compared to $1 million for the third quarter of 2010. International revenue grew 18.7% or 14.3% on a constant currency basis to $3.5 million as compared to the third quarter of 2010. The increase an international revenue was driven primarily by growth and direct European market as well as expansion in select Asian markets.

Now turning to gross margin, gross margin for the third quarter of 2011 were 72.8% as compared with 77.2% for the third quarter of 2010. The change in gross margin was primarily the result of increased mix of revenue from the AtriClip system and cryo devices, which have lower gross margin than our other single use product and increased mix of capital equipment sales and in increased mix of international sales.

Additionally an anticipation of AF laboring in transitioning to manufacturing PMA product, we are in the process of making of variety of modification to our manufacturing and quality systems. As a result we are experiencing in increased in our manufacturing over head cost of portion of which we expect to be temporarily increased, as we have temporarily we aligned internal resources. These changes include revalidation and documentation of our manufacturing process and implementation of our enhanced training program for manufacturing personal.

Additionally during the quarter we experiencing and increased in our manufacturing scrap rate and inefficiency variances, which would driven primarily by higher scrap rate to related to new products manufacturing. We anticipated to continue to experience some pressure on gross margin over the upcoming quarter due to incremental product and manufacturing costs. Next an update on operating expenses, operating expenses increased 2.3% or approximately $270,000 from $12 million for the third quarter of 2010 to $12.3 million for the third quarter of 2011.

Researching development expenses we includes approximately increased approximately $130,000 from $2.9 million for the third quarter of 2010 to $3.1 million for the third quarter of 2011. The increase in R&D expenses with primarily due to increased costs in support of our clinical trials and regulatory activity. Partially offset by a reduction in product development expenses which we do primarily to temporarily reallocation of some personal from product development activity to manufacturing support activity.

This also results in a reduction and product development related project expenditures. SG&A increased approximately $140,000 during primarily by an increasing headcount and travel related expenses associated with the expansion of our worldwide sales and marketing team of approximately $500,000. Partially offset by a reduction in variable compensation for administrative personal before the fourth quarter we expect an increase in SG&A sequentially of approximately 10% to 16% due primarily to expenses to be incurred an anticipation of an AF approval and an increasing variable compensation.

Our operating loss for the quarter was $1.2 million, as compared with approximately $800,000 for the third quarter of 2010, adjusted EBITDA loss with the approximately $65,000. Our net loss per share was $0.07 consistent with the third quarter of 2010. Now turning to cash in the few balance sheet items in terms of cash from operations year-to-date cash using operation was approximately $860,000 this represent of 45% improvement over the first nine months of 2010. We ended the quarter with $15.2 million in cash, cash equivalent and investments.

An increased of $2.6 million as compared to year end, we had $6.8 million in debt outstanding under credit facility and approximately $8 million of incremental borrowing capacity under the revolving portion of the facility. At this point, I would like to turn the call back to Dave.

David Drachman

Thank you, Julie. The peer-reviewed literature suggests that preoperative AF increases the risk of morbidity and mortality. We believe that being the first company to receive a recommendation from in FDA advisory panel for surgical AF indication is a major milestone for cardiac surgery and AtriCure. We are planning for final FDA approval during the first quarter of 2012 and AF approval will allow us to thoroughly train surgeons, which we believe will result in improve patient outcomes this anticipated approval will marked a new era of expansion in growth for AtriCure and conclusion will remain confident in our people and power of our strategic plan.

We will now open the call for your questions.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from the line of (Vivian Cervantes).

Vivian Cervantes

Hi good morning. Thank you for taking my question.

David Drachman

Good morning.

Vivian Cervantes

I would like to start off with comment that you made that there was a 10% reduction and primary surgical procedures in the US, is this temporary and so when do you expect demand to kick back in?

David Drachman

Well, it’s certainly hard to say what now this is temporary or just current trend that we’re seeing. Our indications are the seasonality is typically challenged during the third quarter and one thing likes procedure volumes are also challenged there can be sort of a double dip in terms of both seasonality and procedures. So, we’re optimistic going forward that procedures will begin to trend more in a favorable direction.

Vivian Cervantes

Okay that’s helpful. And then it’s my follow–up very nice momentum in Europe and happy to note your commentary that you expected us to continue. Can you give a bit of compare/contrast on how your sales force traction has been in Europe versus the U.S. with the U.S. not having an AF label?

David Drachman

Well, I think the biggest issue that we face in Europe is that we were just certainly we actually did initiate a full effort in Europe are really start the effort into post IPO, which was August of 2005. So, European subsidiary was basically set up during the first quarter of 2006 and then we began to hire direct people. So we started commercializing our products in 2003 and then where we start a serious effort in Europe in 2006. So, in terms of comparing/contrasting it’s hard to do in terms of our direct markets we have very high quality people in Germany which is our rapidly growing market and as you know the biggest market with 85 million people and represents a very high percentage of the overall cardiac surgical procedures performed in Europe. We also have a very strong direct group in the Benelux, which is another very fruitful area for the company. And we’re considering taking other key market direct over the next 12 to 24 months.

So, overall I think we’re picking up market share in both the U.S. despite the procedures are down we believe that our open market share is increased during 2011 and we are certainly picking up market share particularly in a direct market in the European countries.

Vivian Cervantes

Great thank you. If I may just sneak one quick question in gross margins I know you’d commented that probably going to drag a little bit. When do you anticipate maybe some stability with some of the transition that’s currently on going?

Julie Piton

Probably the back end of 2012, Vivian.

Vivian Cervantes

Okay great, thank you. I’ll get back into queue.

Operator

Our next question comes from the line of (inaudible).

Unidentified Analyst

Hey guys can you hear me.

David Drachman

Hey (inaudible).

Julie Piton

Good morning, (inaudible)

Unidentified Analyst

Hey good morning, congratulations on the panel recommendation. First question is on that topic assuming Q1 approval I guess two parts one is what’s the level of investment you’ll make in the post market study the training and then probably I’m guessing sales force as and then against assuming approval in Q1, when do you expect the label actually began taking hold in terms of driving your top line excuse.

David Drachman

Well, I think first of all in terms of the post approval study. Right now FDA we believe the sort of in a changing the way that they look at these studies. So for example we used to call them post surveillance trials which were more observational nature. Our post approval studies the way that they train today is actually powered to demonstrates safety and efficacy. So we’re in the process of negotiating and collaborating with FDA in terms of what the final trail design is in that we’ll have a lot to do with what the relative costs are. So I’d rather we put that on the back (inaudible) so we have a final post approval study protocol before we began to talk about costs. In terms of the training fees we asks two questions one is cost, well, this is significant cost now in terms of flyings how people around and trying to train physicians on the attributes of our products. We cannot fill how and train physician is obviously on how do apply a product to treated fibrillation. So there will be a significant increasing costs but in terms of looking at this we also intend to leverage STS so for example satellite symposium to at STS, satellite symposiums at ATS and (inaudible). So all our major surgical societies we tend to try to our leverage satellite symposiums at the major societies as well as the smaller more regional meetings also we haven’t institute surgeon training that we developed and we tend to invite surgeons in groups to come here and actually get educated here as well.

So really the cost of the training program has to do more with moving physicians from place to place or sending some of our own clinical educators to those sites which they laughing be in anyway. I think we can if we won’t be in significant but I think the cost going forward is certainly manageable.

Unidentified Analyst

Okay and the second part of that question how do it and when you start, when you think you’ll start to see the benefit of the label in your topline. And I guess what I’m asking is totally what’s your at least feedback from clinicians as to what this means and how quickly you could ramp because of that?

David Drachman

It’s little bit mix in terms of the feedback. So we have surgeons I believe I heard of surgeon yesterday that one year about the approval they want to be where they more accurately label product one that was more on label and this account seems to be shifting over to AtriCure just about on the original panel recommendation. And then we have the groups of others surgeons that don’t fully understand either what their current products are label for what AF labeling means, or what the certification to be an AtriCure–qualified operator means knowing that the certification process is governed and compromise of the experts in surgical AF ablation treatments.

So, I think to answer your question there will be some shift where the announcement of the approval we think that there will be relatively minor we think once we began to get out and talk about the approval and the training. We’re just not over baring it’s very comprehensive with the curriculum is systematically put together we can do the training either on sight or the physicians can come to one of our locations for group training. And I think once these physicians and hospital administrative is realize the advantages of using in on label product we’re going to see a significant trend in terms of market share but also maybe more importantly as we’ve talked about earlier this is about 60,000 patients that are currently undergoing valve and bypass procedures that are been treated. And with our ability to basically educate and train surgeons that are less comfortable using these ablation technologies we think there should be significant penetration into that population of untreated patients today.

Unidentified Analyst

Okay. And if you could just shift maybe to AtriClip real quick, you’ve kind of flat lined here on a quarterly basis. Can you recalibrate us on your expectations for that Clip any measures as you can provide around that commentary a bit helpful? Thanks.

David Drachman

We think that the AtriClip system is still a very significant growth catalyst for the company. We are in the third quarter, we’re tight up with multiple launches of Ice Box product, I think this was the distraction we’ve talked about procedure volumes in cardiac surgery it didn’t help our costs in the third quarter. And just the general seasonality issues. So we continue to be very optimistic about the AtriClip platform now we also think that the entering into a still trial a sole therapy approach to left atrial appendage exclusion for patients are contraindicated for anticoagulation treatment will stimulate interest amongst the surgical community for our AtriClip system.

In addition our post approvals study will include the AtriClip system. So we continue to be optimistic it’s a still a relatively new product there maybe some choppiness to along away but over the long haul we’re very optimistic about the ability for the AtriClip system to a both and extended in the U.S. market.

Unidentified Analyst

All right. Thanks for the time.

Operator

Our next question comes from the line of Jason Mills from Canaccord.

Jason Mills – Canaccord

Hi David and Julie thanks for taking the question, and congrats on the panel again.

David Drachman

Thank you, Jason.

Julie Piton

Thank you, Jason.

Jason Mills – Canaccord

So first question, I’m going to follow up Matt’s question on AtriClip. It’s our understanding that that product is received very well when you’re in the lab with the physician. It’s a new product, as you mentioned. There’s still a little bit of handholding that the company’s reps must do. I’m wondering as you get the labeling, you have a robust training program in place for your ablation franchise. You mentioned the halo effect. Perhaps give us a bit more commentary on that, because it seems like as you’re in more accounts more often, that perhaps that halo effect – it has some validity. Perhaps provide a little bit of color on that and how we could see sequentially AtriClip trend post FDA approval of Synergy?

David Drachman

I think that’s an excellent point Jason, and thank you, for expanding on it. I think you pretty much said the story, which is that as we’re educating physicians, we will be educating them on the advantages for the on-label use of the AtriClip system. In fact, we just started a training program at a major center for the AtriClip, that training center had good turnout and I think physicians as they begin to do more complete Maze procedure.

So in our ABLATE clinical trial as you know the Maze IV, which is a Biatrial procedure, as we teach them the more complete Maze procedures, will also want to take the most least burdensome approach to left atrial appendage exclusion, which is the AtriClip system. So, I think the fact that we’re training surgeons to do more complete lesion sets or they want to reduce their time in terms of excising and sewing the appendage and also reduce the complications. And we can also educate them on the benefits of the AtriClip simultaneously, since both the ablation and the clip will be on labeled products.

Jason Mills – Canaccord

That’s helpful. So just as a follow-up to that, just as we think about quarterly progression, would it make sense that we’re – we’re in the sort of $1.5 million range now, that we’re probably within that range to may be up to a couple million, $1.5 million to $2 million a quarter for may be the next couple of quarters. And then Q1 approval of ablation of Synergy in combination with a mid-year second half launch of the stroke trial, we could see maybe the quarterly progression accelerate perhaps in the back half of the year. Is that a good way to think about it?

David Drachman

I think that’s a very reasonable expectation to believe that as we begin to put together the pieces of our Institute of Training and further develop our training programs, our Education Steering Committee and all the elements that are required to meet our FDA mandate for training and education; as we put that together in the first half of 2012, that will begin to reap the benefits both from the ablation side as well as from the clip side in the second half of 2012. That is very well said.

Jason Mills – Canaccord

And then you got the ICD-9 code that started on the first of this past month, I suppose, helps as well. Okay, the second question for me is sort of question area for me is on the ablation front. It’s sort of, it’s sort of an interesting just to position it seems, whereas the penetration of surgical ablation sort of patient candidates is still really low according to our estimates. But we’re seeing ablation sort of growth, it’s still growing, but at a modest pace. I’m wondering if you could give us a sense for, growth in ablation in this country and sort of what we should expect that growth to do next year, the year after.

And then, just – I’ll sneak another one in for Julie, just with respect to your commentary in gross margins, do you expect – us to go a little bit lower here before we start trending up or is this kind of the range of sort of low watermark for your gross margins? And I’ll hop back in queue. Thanks, guys.

David Drachman

Well, Jason, I’ll just answer your first question. This is clearly and this was mentioned by FDA during the Advisory Panel Meeting. There it’s clearly an increased awareness of atrial fibrillation and the associated mortalities and increased mortality with AF. And I think as you know in September, Congress passed – September, a resolution in September would become AF awareness month. So it’s well known that AF is a growing epidemic that the incidents and prevalence of AF is expanding. And I think that there is also awareness that there have not been a complete set of treatments to address the problem. So with the AF approval on the concomitant setting and the ability to basically not just educate and train surgeons but also educate referring physicians, as well as patients, we think that this is the key to actually stimulating growth in the undertreated population of concomitant patients.

Along with that, we need to make sure that as we basically train surgeons that they get outcomes that are consistent with the ABLATE clinical trial, in the past because we haven’t been able to train surgeons a lot of the outcomes have been wide ranging in the concomitant area of surgical ablation and only really a few of the highly experience centers have been able to consistently get good, safety, and efficacy outcome. So with the training program, with the ability to educate and train patients, and get surgeons doing Biatrial complete lesion sets and increasing the efficacy and maintaining a good list of benefit ratio, as well as would be overall awareness of the problem and the scope of the problem, we would anticipate a very bright future for ablation at AtriCure.

Jason Mills – Canaccord

Thank you.

Julie Piton

And gross margin Jason, I would like to think of this as a low watermark within, let’s say – say let’s say with our 100 basis points and hopefully upside to that, but cautiously optimistic about the upside in the short-term.

Operator

Our next question comes from the line Tom Gunderson from Piper Jaffray.

Thomas Gunderson – Piper Jaffray

Hi.

David Drachman

Hi, Tom.

Julie Piton

Good morning, Tom.

Thomas Gunderson – Piper Jaffray

Hi guys. Dave, you said you’re looking to register the products in Brazil that opens up question of – can you remind us or gives us a view of what you think might be the low hanging fruits and would you go after Russia, India and China as well?

David Drachman

We’re already selling products in Russia and we do very well in China. Actually when we look at our two major markets in Asia it’s Japan and China and we’re growing in Japan, but we have significant share there. If I look at the major cities; Beijing, Shanghai and Guangzhou, there’s still significant opportunity for growth in China. And we’re looking and evaluating different sales and marketing scenarios to support our stock and distributor partner in China.

In terms of Brazil, I think the issues of cost per procedure could be somewhat constraining. There is certainly a large pack of ablation patients and they are just in surgical ablation. So I think that could be a very opportunistic market for us in the second half of 2012. And in terms of India, I don’t really anticipate a lot of movement in India, based on transfer pricing and what the end user pricing is in India.

Currently we’re not really locking the figure to enter that market. We are looking at basically some low cost options of our products for some of the third-world underdeveloped countries, end markets as a potential way to enter these markets. But right now, I think China very strong, Brazil, good opportunity. But I think those are our two main areas of the new market penetration.

Thomas Gunderson – Piper Jaffray

Got it, thanks. And then if I switch to the FDA, you said you expected approval for the AF indication in Q1. That fits with our common sense. Have you had any post panel conversations or any data that would help us put error margins around the first quarter, when that’s sort of hard to define FDA.

David Drachman

Only the typical sort of handshaking, and we certainly let FDA know, following the panel meeting, that we fully appreciate their interactive and responsive nature to our submission and it’s been that way throughout the entire process in putting together the panel packs or the panel members and in reviewing all that information, the FDA has just been very interactive and responsive and when we look at what FDA has to basically decide, we believe the two major issues are product labeling in terms of clinical data and they will label the product.

And then secondly is, a refinement of the post approval study, which we have had a conversation about the post approval study, which was part of the panel pack that went out six weeks and prior to panel, we have had conversation about a post approval study now for probably four or five months. So, we feel pretty comfortable that we are fairly close because the clinical data speaks for itself and the post approval study has been an ongoing discussion and we just have a good sensation following the meeting that FDA would view a sooner than later approval as a positive thing for patients and the industry.

Thomas Gunderson – Piper Jaffray

Got it, thanks. And then just a quick clarification from Julie, could you repeat what you said about SG&A for Q4 numbers?

Julie Piton

At expected sequential increase of 10% to 15%.

Thomas Gunderson – Piper Jaffray

Thanks.

Julie Piton

You’re welcome.

Operator

(Operator Instructions) Our next question comes from the line of Charley Jones from Barrington Research.

Charley Jones – Barrington Research

Good morning. Congratulations and thanks for taking my questions.

Julie Piton

Thanks, Charley.

Charley Jones – Barrington Research

A couple of questions on the clip. I was curious if you’d started to detail that to competitive accounts, and I’m curious also, is it being held back at all by Products Review Board? And then finally on this topic, is it really just up to the surgeon 100% or is there any reason that you need to go after referring physicians you have to increase volumes there?

David Drachman

Well, I think Charley good questions, there is certainly the value analysis committees are dragging it out. So typically we like to think about phase I selling, is selling to physician on the superiority of product and phase II selling is selling to physician and helping you to get to product on the shelf. And the phase II part of the selling with value analysis committees that are very cost cautious and House of Administrators that are although bit more challenged in today’s macroeconomic environment, is the longer process.

Overall, we think that the feedback from AtriClip has been very positive. We’ve made some modest what we call running changes improvements to the performance of the product. And we also have a product that we anticipate coming up by mid-year 2012 that will be an enhancement to our current platform. And as we said earlier, we think that the initiation for the stroke trial within cardiac surgery, should really raise the level of awareness. And then I think somebody mentioned earlier the halo effect of training and education and being able to combine our ablation tools with the AtriClip system should also stimulate growth in this area.

Charley Jones – Barrington Research

So would you say there are physicians that are using the product pretty regularly the way you thought that they would that have given a good reason for it and do you – is there next-generation product that they are waiting for or data or is it just experience I think would be required to get them out of the hump?

David Drachman

I think its number one, it’s peer-to-peer communication, so as we train and educate surgeons and they talk about the benefits of the AtriClip system and as we train and educate surgeons to do buy atrial maze procedures. As we talked about earlier I think that will also facilitate more clip usage because that will reduce the overall time of the procedure and at the same time, we have had some running changes to the product as it exists today to help improve the performance of the product and then with the next generation platform coming out around mid-2012 that should also help.

So, much of than I mentioned, your question is – but we still are very optimistic about the AtriClip system. We still believe it has significant advantages. We are still improving the platform. It is our first fully implantable device and our sales our organization I think remains confident about their ability to sell the clip.

Charley Jones – Barrington Research

That’s great, couple of questions on you competition. Could you remind us where they are in their surgical AF indication process and then you have talked about it a little bit with Matt, can you discuss hospitals’ appetite for switching over into your products and from Medtronic and how the Clip kind of plays into all this.

David Drachman

If I were to give you any information about – any real information about where our competition stands in terms of also having an AF indication, it would be more hearsay than fact. So I’d rather stay away from that.

It is our interpretation that we have a fairly significant lead in this area. So it would be surprising to us if we didn’t have the 6 moth to 12 month lead in terms of having first mover advantage with the indication.

Charley Jones – Barrington Research

I’m looking here at the clinical.gov website and I see one trial completed for cardio ABLATE. But it’s just a pulmonary vein isolation, which I don’t think has any chance of showing the efficacy that you need and the Alder say active in that recruiting. So, we’ve heard that they’re really not even in a trial right now, that is going to be able to get them to that approval. Is there – can you lead us to some place we can look to be able to confirm that?

David Drachman

I have no additional information than what you cited Charley. I think again we feel like we have a significant first mover advantage, but we don’t have focus ability to our competition. And so we are focused on executing our plan and getting out ahead of the power curve as much as possible.

Charley Jones – Barrington Research

Or maybe you can leave it at this end, so when you talk to this hospital that switched over to your products as a result of the panel’s recommendation. What are the advantages for those hospitals to use your products on label post to using products that are not label and appear to could not be in a trial at this moment in time?

David Drachman

Well, I think if you put yourself in a physician’s position, if you have the choice of using first of all we are the market leader in the surgical treatment of AF in the U.S. We believe we have superior technologies and products, and we have a wider range of products and technologies.

So fewer physician and you want to work with a single company, and that company happens to have a product it’s labeled for atrial fibrillation and you are using it to treat atrial fibrillation and the other companies have labels for cardiac tissue ablation. We think that there would be a presence in terms of using in the physicians prospected using a more accurately labeled product.

And then when we look at hospital administrators, we also think that there is risk committees and risk analysis at hospital and hospital committee levels that would prefer to use more accurately labeled product. And once again, the hospital also enjoys the benefit of working with the market leader and working with a company with the widest range of products and technologies in this space and the company is offering training. So if you’re a hospital administrator and there is an FDA mandate to train surgeons, wouldn’t you rather have your surgeons be trained as certified AtriCure operators, who are trained in the surgical treatment of atrial fibrillation, which is the only formalized concomitant surgical AF program for training and education.

And then lastly, I think hospitals want to promote the fact that they have the widest variety and the most comprehensive treatments for this disease, atrial fibrillation, which is a national epidemic and certainly has a lot of national awareness. So I think those are some of the reasons why we believe we have a competitive advantage going forward.

Charley Jones – Barrington Research

Can you remind us Medtronic’s market share in the U.S.?

David Drachman

Our best estimate of Medtronic’s overall market share in the U.S. is about 40%.

Charley Jones – Barrington Research

I’ll jump back in queue. Thanks.

Julie Piton

Thanks Charley.

Operator

And our next question comes from the line of Larry Haimovitch from HMTC.

Larry Haimovitch – HMTC

Good morning Julie and good morning Dave.

David Drachman

Hey, Larry.

Julie Piton

Good morning Larry.

Larry Haimovitch – HMTC

Can you make some comments on the standalone market, I don’t think I heard anything in the prepared remarks that was a very promising area for you, it seems to have slowed down, you talked about it in the last conference call regarding it’s – the impact of DEEP AF. Any updated comments you can share with us?

David Drachman

Well first of all I think we are very optimistic about the sole-therapy treatment of atrial fibrillation and actually believe that the concomitant surgical AF indication marks a significant event for surgical ablation and allows us to do a better job in treating patients that undergo surgical procedures and have Preoperative AF. If we do a better job and expand that market, we think that bodes very well for sole-therapy market.

Then there’s more and more patients being treated with catheter ablation and obviously, many of those patients need second and third producers, which we think, if we can get more exposure for a surgical treatment of atrial fibrillation with an indication, that people will take a second look at sole-therapy procedures. And as we’ve talked about on previous calls, we’ve lessoned our training in 2010 in this minimally invasive hybrid area and constrained it only FDA-regulated study.

So we’re taking a more long-term view on the minimally invasive or sole-therapy hybrid approach and want make sure that we are compliant and work with FDA on getting the proper approvals in place. We believe that once this DEEP AF trial, we anticipate it getting into a pivotal phase on time in late 2012. And then going from six to approximately 35 sites, they’re investigating this procedural. We’ll also create exposure and potentially a result in physician adoption of these types of procedures.

Julie Piton

Yeah, I think just to add on to that Larry, the prepared comments, I think we’re consistent with our second quarter commentary. From a revenue perspective, the business is performing in line with what we expect it to do when we expect those trends to be in place really until the second half of 2012 when we anticipate moving to the pivotal trial. We have enrolled 24 of the 30 patients in the DEEP trial. And as Dave said, it’s still very optimistic about that large market opportunity.

Larry Haimovitch – HMTC

With sole-therapy procedures down Q3-over-Q3 last year, Julie?

Julie Piton

Yes, they were.

Larry Haimovitch – HMTC

They were, any order magnitude 5%, 10%, 20%?

Julie Piton

We really don’t have that order of magnitude to provide to you. I would say they were relatively consistent with the second quarter of 2000. Sequentially, they were relatively consistent with what we’ve been seeing.

Larry Haimovitch – HMTC

And ASP is still in the 10% or 11%, 12% – 12 million, 12,000 range rather?

Julie Piton

ASPs continued.

Larry Haimovitch – HMTC

Yeah, okay thanks.

Julie Piton

Thank you, Larry.

Operator

And we have follow-up question from the line of Charley Jones from Barrington Research.

Charley Jones – Barrington Research

Yeah David, thanks. How many centers, how many centers are you going to have included in your post approval study that were traditionally Medtronic accounts and have you already seen that benefit where they started to trial your devices or do you kind of expect to see that more as the trial begins or as we move into – the post approval study begins or as we move into 2012?

David Drachman

I can’t say you how many specific Medtronic users have in the study. We anticipate being approved for 50 sites. And based on our current thinking is that we would have 10, what we call new users. So that 10 of the sites would be new users and part of the reason for that is so that we can measure the effectiveness of our training program and see how the 10 million users do in comparison to the patients that are enrolled in the ABLATE clinical trial.

Charley Jones – Barrington Research

And on the DEEP AF, could you remind us what types of results you’re seeing there from single centers and if we use the more strict guidelines for major as of antiarrhythmic free at six months. What are those results look like for a single centre?

David Drachman

It’s really too early within the DEEP AF trial. We haven’t adjudicated all the results in that trial yet, but our general sense of things is that the results were trending very favorably in terms of both safety as well as efficacy, and we would anticipate that it would be somewhat consistent with some of the peer reviewed literature and physician reports, which range in from 80% to 85% typically speaking in this population of patients with persistent and long-standing persistent AF patients that are – that many have also failed the catheter ablation. So the DEEP AF is persistent, long-standing persistent and also patients can be enrolled in a trial if they have persistent and long-standing persistent with or without DEEP AF ablation.

Charley Jones – Barrington Research

So I think in the past you’ve talked about this 80% to 90% range. Is it fair to haircut that number for the antiarrhythmic drugs or is that just the way we’ve been looking at it now and so when you grow 80% to 90%, you’re actually thinking of it from the perspective of getting them the entire – of the entire arithmetic’s?

David Drachman

The physician reports which are not prospective randomized controlled trials and but typically not as rigorous in terms of their reports, but they are in that 80 plus percent range. I think one thing that you can take away is that in the sickest patients, so if you take a look at our ABLATE and ABLATE AF there, these are obviously patients that 25% of them had double valves for example and 45 – 40% of the patients had two primary reasons for their cardiac surgical correction procedure, for example cabbage in the valve procedure.

And if you look at those 40% of two primary indications and 25% of double valves and a median 61 months of preexisting atrial fibrillation preoperatively, and the median 8, 72 years old in a median left atrial size of six centimeters and the six months results on non-paroxysmal patients, when you combine ABLATE and ABLATE AF with 75% of antiarrhythmic drug.

We anticipate performing basically the same lesions had with thoracoscopic approach combined with thoracoscopic approaches and catheter optimization in our hybrid procedure. So when we look at that history that gives us optimism that the results from the DEEP AF trial should be somewhat in line with the physician – independent physician reports.

Charley Jones – Barrington Research

Okay. Last one here, could you discuss the importance of including paroxysmal patients in the post approval study and your appetite for that? I am sorry, I missed your response, have you started detailing the clip to competitive accounts yet? Thank you very much.

David Drachman

Okay, thank you, Charley. In certain situations we have started to detail certain targeted capital accounts. And in terms of post-approval study, we’re not necessarily in a position to talk much about including patients, it was something that came up at panel, but typically in post-approval study, and again some of the landscape is changing gears from our regulatory perspective. But typically post-approval studies actually include the indication that was approved.

So right now persistent and long-standing, persistent AF is what’s in the proposed indication. So a typical post surveillance trial in previous days would not really allow you to include and extend indication in your post surveillance trial. Again, the landscape is changing we’re now conducting these post-approval studies that have empowered industry safety and efficacy. So we’ll have to see as we get into further discussion with FDA and whether or not there – what views are and what the pay/cost issues are – of including the paroxysmal population.

Charley Jones – Barrington Research

Thanks again.

Julie Piton

Thank you.

David Drachman

Thank you.

Julie Piton

Operator, we’ll take one more question please.

Operator

Our next question comes from the line of Jose Haresco with JMP Securities.

Jose Haresco – JMP Securities

Hi guys, good morning and congratulations again on that panel note.

Julie Piton

Thank you, Jose.

David Drachman

Thanks, Jose.

Jose Haresco – JMP Securities

I just have a quick question here. As we start look forward to 2012 and approval of the device or expansion of the device rather, could you walk us through kind of your plans for – your infrastructure in terms of sales, marketing, training, in order to be able to train all these centers without distracting from the regular pace of business? Should we build that into our models as we look forward?

David Drachman

I think there is place in terms of building a surgeon training model into our cost structure. I think, if you look at the program, we’re looking at VP of Clinical Education. We’re trying to fill that position now. We’ve already hired Dr. Sydney Gaynor, who is a well-known expert in surgical treatments of AF, and who was the first author of some of the early Ralph Damiano maze IV procedures coming out of Washington University.

We have three or four other positions that we want to fill to sort of initiate this Surgeon Institute of Training. And so I think there will be some additional costs. Again we’re going to try to leverage the major meetings as well as our institute as well as our VIP visits, as well as the fact that Sydney and some other clinical educators will be able to basically perform training on-site. So we haven’t gotten to a range and a time point where we’ve completely wetted the increase cost structure, but we are in the process of doing right now.

Jose Haresco – JMP Securities

Okay. Great thank you very much.

David Drachman

Thank you.

Julie Piton

Thank you Jose.

Operator

And ladies and gentlemen. I’d like to turn the call back over to Mr. Drachman for closing remarks?

David Drachman

Well, thank you very much again for your support. And we look forward to our upcoming fourth quarter earnings call. Thank you very much.

Operator

Ladies and gentlemen that concludes today’s conference. We thank you for your participation. You may now disconnect. Have a great day.

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