AtriCure, Inc.
Q4 2011 Earnings Call Transcript

Published: 28 Feb 2012

[Operator:]

Good afternoon, and welcome to the AtriCure’s Fourth Quarter and Full Year 2011 Earnings Conference Call. My name is, Diana, and I’ll be the coordinator for today’s call. 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. As a reminder, this conference 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 J. Drachman:]

Thank you, Diana. Good morning, and welcome to our fourth 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 A. Piton:]

Thank you, Dave, and good afternoon, 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 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 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 may 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 that the Food and Drug Administration, or FDA, has not approved certain AtriCure products for the treatment of atrial fibrillation or AF, or for stroke reduction. The company and others acting on its behalf may not promote these non-approved products or train doctors for the surgical treatment of AF or stroke reduction unless the product is so indicated. 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 only 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 including for the treatment of atrial fibrillation in accordance with the product specific indications. With that, I would like to turn the call back to Dave.

[David J. Drachman:]

Thank you, Julie. The AtriCure Synergy Ablation System is the first and only surgical ablation system FDA approved for the treatment of AF, and the only ablation technology approved for persistent and long-standing persistent atrial fibrillation. We believe this system’s recent FDA approval for the treatment of AF during open concomitant surgical procedures is a major milestone for cardiac surgery, and provides AtriCure with new opportunities for expansion and growth. Our highest strategic priority is accelerating U.S. growth. We plan to leverage our AF approval by providing surgeons with concrete hints of training. We also believe that a well executed concomitant AF training and market development plan is the foundation for an advanced minimally invasive thoracoscopic ablation approach, which represents a major growth opportunity. Our research suggests that in the U.S., 85,000 patients per year undergo coronary bypass and/or valve procedures with a diagnosis of preoperative AF. Of these 85,000 patients, approximately 25% are currently receiving ablation treatment. Our growth strategy is designed to improve patient outcomes, gaining market share and increase penetration above the 25% level through comprehensive training and carefully well-selected patients. Going forward, we anticipate stabilization of the macroeconomic pressures impacting hospitals and procedure volumes. We believe our technology and our clinical leadership, and powerful market development drivers, as a result we are planning for accelerated U.S. growth throughout the year and strong growth from the international markets during 2012. In preparation of our expansion and growth plans, we enhanced our executive leadership team with the addition of Andrew Lux, as our Chief Operating Officer. Andrew has held leadership positions with Medtronic’s Cardiac Surgery Division, Johnson & Johnson, and General Electric. He has a proven track record of implementing world-class manufacturing systems and developing innovative technologies, which have been widely adopted in the marketplace. Andrew has responsibility for worldwide operations as well as product research and development. Turning to our training program, as a condition of FDA approval, we agreed to train and certify existing Synergy System users within 18 months, and to train new users prior to their purchase of the system. Our professional education team has plans to make trainee accessible and convenient for all surgeons. Our first training event was held in Fort Lauderdale in conjunction with the recent STS meeting, and attendance exceeding capacity with approximately 100 participating surgeons. In order to leverage our AF approval and training plans to accelerate growth, we recently realigned our U.S. sales organization into nine regional rhythm management teams. The aim of our sales realignment is to support our training initiatives and monitor the effectiveness of our training investments. We believe our sales realignment will facilitate an increase in the use of our Ablation products and the AtriClip system through that halo effect created by our surgeon training programs and approval. Moreover, our sales alignment promotes effective partnering strategies with physicians and administrators in order to raise awareness, improve patient outcomes and increase penetration in appropriately well selected patients. Moving on to fourth quarter results, consolidated fourth quarter revenue of $16.8 million, grew 2% compared to the same period a year ago. U.S. revenue of $12.4 million was down 5% compared to prior year. Fourth quarter U.S. results were impacted by a decrease in minimally invasive product sales. This decrease in minimally invasive sales was primarily a result of strong capital equipment performance from our ORLab in the prior year. Furthermore, our research suggests a high single-digit decline in open-heart procedures during the fourth quarter of 2011. On a sequential basis, minimally invasive product sales increased, and U.S. revenue was up 5%. International revenue for the fourth quarter of 2011 was a record $4.4 million, representing 32% constant currency growth. We anticipate continued high growth in Europe as the majority of our business and growth opportunity is in the northern countries, which are less affected by the macroeconomics and austerity measures than Southern Europe. Importantly, Europe benefits from our ability to train physicians on the use of our products for minimally invasive thoracoscopic ablation procedures. They are also products used in minimally invasive procedures, has continued to demonstrate high growth and currently account for approximately 40% of sales from Europe. Similar to other emerging medical device platforms, we believe that our minimally invasive performance in Europe provides insight and deformation for our investments in minimally invasive FDA clinical trials. Additionally, we anticipate continued growth from Asia, and have plans for geographic expansion. As a result, we anticipate strong growth from our international markets. In terms of gross margin trends, pricing from our disposable products in the U.S. and our International markets has remained generally consistent, which we attribute to premium products. During the second quarter of 2011, we implemented a quality system improvement plan that included a revalidation of our manufacturing processes, which resulted in short-term inefficiencies and increased scrap rates. This plan was in response to receipt of a Form 43 in February of 2011 and to prepare for the requirements associated with PMA-manufactured products. Our 43 is listed on the FDA website as Voluntary Action Indicated, and we received an Establishment Inspection Report in October of 2011. We are highly focused on implementing quality and manufacturing systems that are increasing efficiencies and reducing scrap rates. As a result, we anticipate significant gross margin improvement throughout the year. Turning to our investment in clinical science and FDA approvals; as a condition of our approval, we agreed to conduct a post-approval study. The primary post-approval study requirements were outlined and agreed upon prior to the final FDA approval, and the recent submission of our clinical plan. Our post-approval study is designed to monitor the safety and efficacy of the Synergy System to perform the Maze IV procedure during commercial use in carefully selected well trained sites. The post-approval study will enroll and treat 350 patients at a maximum of 50 sites and is designed with safety and efficacy endpoints. Notably, following completion of our ABLATE pivotal clinical trail, we initiated an FDA approved continued access registry ABLATE AF. We completed enrollment in our 50-patient registry and received an extension to enroll an additional 25 patients. To-date, we have 53 enrolled patients in the ABLATE AF registry and we are continuing to enroll, while the post-approval study is being reviewed by FDA. Importantly, FDA has agreed that all patients enrolled in the ABLATE AF registry will be transferred to the post-approval database and counted as post-approval study patients. Therefore, we will be initiating enrollment in the post-approval study with patients from ABLATE AF, leaving less than 300 patients to enroll. The primary efficacy endpoint will be the proportion of patients AF-free as defined in the 2007 HRS consensus statement, a three year follow-up based on 48-hour monitoring. The primary safety endpoint is the proportion of patients with a serious device or ablation procedure related adverse event within 30 days post-procedure. Now, moving to the DEEP AF clinical trial, based on a series of meetings with our investigators and FDA, we submitted our staged DEEP AF feasibility protocol to FDA. The patient population for staged DEEP AF is the same as our original protocol. The aim of this study is to assess safety and technical feasibility of treating patients that are refractory to anti-arrhythmic drugs, and present with persistent or long-standing persistent AF with or without a previous dealt cath ablation. This study is expected to enroll a maximum of 30 patients at up to six sites. This investigational procedure combines our platform of product design for minimally invasive thoracoscopic ablation with catheter mapping and ablation technologies in order to replicate a complete Maze procedure. Following the thoracoscopic ablation, a separate staged EP optimization procedure is performed during the same hospitalization. The staged approach elevates the scheduling challenges of a combined single session procedure and places the surgeon and EP in their most familiar environments. Developing this protocol, we had a successful meeting with FDA and accomplished our primary aims. First FDA agreed on a primary safety endpoint of pre-specified serious adverse events through 30-days. This differs from the catch-all approach that was required to the first same session hybrid trial. In designing the safety way of approach, FDA helped develop pre-specified serious adverse events that are most consistent in terms of their level of severity for determining the primary endpoint. Importantly, FDA agreed to review safety data 30-days after the patient’s ablation procedure. We plan to initiate enrollment the staged DEEP AF feasibility trial during the second half of 2012. Now, turning to our stroke trial, on December 21, 2011, we received full FDA approval to conduct an IDE feasibility study for the AtriClip, Left Atrial Appendage Exclusion system to assess stroke prophylaxis when delivered through a sole therapy procedure using a thoracoscopic approach. The aim of this project is to start the process of demonstrating that the AtriClip system reduces the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation for whom long-term oral coagulation – anti-coagulation therapy is currently indicated. This safety and feasibility trial will enroll up to 30 patients at six sites. Notably, the IDE is approved with our current AtriClip system. However, we are developing a more advanced AtriClip platform, which is designed for use in open and minimally invasive thoracoscopic procedures. This advanced AtriClip design has received positive feedback from our stroke clinical investigators. Therefore, our strategy is to supplement the approved IDE with a new generation AtriClip system, and initiate enrollment in the trial during the second half of 2012. In addition, because the new AtriClip system is designed for both open and minimally invasive thoracoscopic procedures, we’ve planned to submit a 510(k) at the same time we submit our IDE supplement in support of our stroke feasibility trial. The aim of our 510(k) submission is to receive FDA clearance for open concomitant procedures, which is consistent with the labeling and support of our current AtriClip system. Julie will now provide a detailed review of our fourth quarter financials.

[Julie A. Piton:]

Thank you, Dave. I’ll begin by providing high level financial information related to 2011, and will then focus my comments on fourth quarter results. Our 2011 revenue was $64.4 million, representing growth of 9%. Our U.S. business grew 3%, and our International business was up 35% on a GAAP basis, and 31% on a constant currency basis. Our gross margin for 2011 was 73% as compared to 76.9% for 2010. Gross margin reduction was primarily associated with an increase in manufacturing overhead cost, variances and scrap. As we enter 2012, we expect these increased manufacturing-related costs and inefficiencies to reduce, resulting in improved gross margins over time. Gross margin also reflects an increased mix of international sales. Our operating loss was $4.7 million, and our net loss per share was $0.35. Now, transitioning to our fourth quarter financial performance, for the fourth quarter of 2011, revenue increased 2% to $16.8 million. Revenue from product sales in the U.S. was $12.4 million. Revenue from ablation-related product sales in the U.S. decreased by approximately $800,000 driven primarily by a decrease of approximately $600,000 in sales of products used in minimally invasive procedures. Note that fourth quarter of 2010 minimally invasive product sales benefited from an unusually high number of ORLab sales. Sequentially, revenue from minimally invasive product sales increased 9%. U.S. sales of AtriClip system during the quarter were $1.4 million as compared to $1.3 million for the fourth quarter of 2010. International revenue for the fourth quarter of 2011 grew 32% on both a GAAP and constant currency basis to a record $4.4 million as compared to the fourth quarter of 2010. The increase in international revenue was driven primarily by growth in our direct European markets as well as an expansion in select Asian markets. Now turning to gross margins; gross margin for the fourth quarter of 2011 was 70% as compared with 75.1% for the fourth quarter of 2010. The change in gross margin was primarily the result of increased manufacturing overhead, inefficiency and scrap-related expenses, which accounted for substantially all of the gross margin fluctuation. During the quarter, we experienced an increase in our manufacturing scrap rate and inefficiency variances. Under the direction of Andrew Lux, our new COO, we will, over the upcoming months be highly focused on establishing enhanced operational processes to drive the increased efficiencies and reduced scrap rate. We anticipate continued pressure on our gross margins over the upcoming quarters due to incremental product and manufacturing cost. However, we expect gross margins to incrementally improve throughout 2012. Next, an update on operating expenses. Operating expenses increased 7.1% or approximately $900,000 from $12.5 million for the fourth quarter of 2010 to $13.4 million for the fourth quarter of 2011. Research and development expenses, which include clinical activities, decreased by approximately $550,000 from $3.5 million for the fourth quarter of 2010 to $3 million for the fourth quarter of 2011. Included in R&D during the quarter was a $300,000 non-recurring gain on the sale of our patents. Further, the decrease in R&D expenses was primarily due to a reduction in product development expenses associated with the reduction in new product expenditures as compared to last year's fourth quarter. These reductions were partially offset by increased cost in support of our clinical trials and regulatory activities, particularly expenses associated with our panel meeting and expenses associated with our panel meeting and expenses to support our AF approval. SG&A increased $1.4 million, driven primarily by an increase in head count and travel expenses associated with the expansion of our worldwide sales and marketing team of approximately $600,000, and increased training, education and marketing expenses of approximately $500,000. Our operating loss for the quarter was $1.7 million as compared with approximately $200,000 for the fourth quarter of 2010. Adjusted EBITDA loss was approximately $600,000. Our net loss per share was $0.13. As we look forward to 2012, from an expense perspective, we would expect net incremental expense for R&D of approximately $1.5 million to $2 million. The increase is primarily due to incremental expenses associated with the open-heart AF post-approval study and expenses for the development of a next generation RF generator. Additionally, we expect cost in support of the education training program during 2012 to be approximately $1.5 million. However, about half of these expenses relate to a realignment of internal resources. As a result, the net year-over-year increment is expected to be approximately half of the $1.5 million, or roughly $750,000. Now turning to a few balance sheet items; we ended the year with $14.2 million in cash, cash equivalents and investments. Additionally, we had approximately $8 million of borrowing capacity under the unused revolving portion of our credit facility. During February, we amended our credit facility, providing for a new five-year term loan of $10 million, which resulted in incremental cash of approximately $3.8 million and expanded the overall facility to a $20 million facility. We believe our current cash position will support the execution of our strategic plans. At this point, I would like to turn the call back to Dave.

[David J. Drachman:]

Thank you, Julie. In terms of outlook, we entered 2012 with a strong balance sheet well positioned to accelerate U.S. growth and profitability trends throughout the year. Additionally, we are poised for strong growth from our international markets, gross margin expansion and to advance our minimally invasive thoracoscopic ablation and stroke initiatives. In conclusion, we are confident in our people and the power of our strategic plan. We will now open the call for your questions.

[Operator:]

(Operator Instructions) The first question will come from the line of Tom Gunderson, Piper Jaffray.

[Thomas J. Gunderson:]

Hi, guys.

[David J. Drachman:]

Hi, Tom.

[Julie A. Piton:]

Good morning, Tom.

[Thomas J. Gunderson:]

So I was hoping we could get a little bit more color on next steps now that we finally have the FDA approval in hand, and that would be, I believe your first large training, maybe your first training post-approval was done in Fort Lauderdale. Dave, can you give us a little color on how that went, the – maybe the proportion of existing and new docs and just kind of the overall tone and what you gained coming out of that?

[David J. Drachman:]

Sure, good question, Tom. So in terms of the training and education initiative, first of all, we look at this training and education initiative, first to improve patient outcomes, which we believe will increase adoption and penetration into the market. In terms of the 100 physicians that came, about two-thirds of the physicians were existing users. Most importantly, I think what we learned was that there is a significant interest in the development of this marketplace, but there’s been a lack of training. Our product has been available for about 10 years, and yet we had overcapacity in a 100 physicians, 71 which were current users coming to learn more about how to treat atrial fibrillation, both in the preoperative, intra-operative and post-operative period. Second thing that we learned is that the surgeons that come to training, and training the surgeons is not really the main initiative. The main initiative is to train the surgeons and make them confident in their ability to treat complex structural heart disease and integrate the ablation procedure into those complex, structural heart disease corrective operations, and then to increase the utilization. So just by training physicians and certifying them, that’s Phase I. What we need to do is go deeper than that, and we need to stay close to these physicians and monitor the effectiveness of the training and in some cases, provide more training and more follow-up to make sure that we take advantage of this access opportunity that we have to the community of cardiac surgeons to improve outcomes through training, but also to increase utilization and adoption and to create a halo effect for not just the approved product but the ancillary products that support it, as well as the AtriClip system.

[Thomas J. Gunderson:]

Thanks. And then the follow-up would be with regards to guidelines, whether they are STS guidelines or otherwise. I’m getting a sense that these are improving for AtriCure. What – Dave if you could, what’s the current status and where do you expect this to go in 2012?

[David J. Drachman:]

Well, the current status is, basically the HRS guidelines is recommending treatment for patients that are undergoing corrective surgical procedures that have preoperative AF, that are symptomatic or non-symptomatic patients where there is not the significant risk of adding the ablation procedure. The STS also recommends the use of surgical ablation, and the society is mixed, which is the minimally invasive society for cardiac surgery also has evidence and is recommending treatment of preoperative atrial fibrillation with surgical techniques. So I think the evidence is building. Certainly the major societies are supporting the treatment of preoperative atrial fibrillation. I think where we see this going is that, the patients that undergo corrective surgical procedures with preoperative atrial fibrillation, most of these patients are refractory to all other types of treatments. While their chest is open, while they’re in the operating room, we can make scars, reproducible scars which are required to create a maximum treatment for this disease, and we can get high cure rates. So I think the trend is, while the patients are in EOR, give the surgeons the skills to understand how they integrate the ablation procedure into the open, surgical corrective operation.

[Thomas J. Gunderson:]

Got it. Thank you.

[David J. Drachman:]

Thank you.

[Julie A. Piton:]

Thank you, Tom.

[Operator:]

The next question comes from the line of Matt Dolan, Roth Capital.

[Matt Dolan:]

Hey guys, can you hear me, okay?

[David J. Drachman:]

Okay.

[Matt Dolan:]

Great. First question is falling up on the first comments around the label, Dave, obviously you have some heavy lifting ahead of you in terms of training and certification in the post-approval study. So maybe you could just give us – you did say, you expect sales to begin to accelerate again, maybe help us with how we should think about the timing of the impact of all this once you get reduction in row as it relates to training in the post-approval study? Then secondly, competitively how do you – what company strategy you’re after competitive share with the label in hand. Thanks.

[David J. Drachman:]

Thanks, Matt. Well, certainly we would anticipate that the growth would be stronger in the second half of the year as we get further on down the road, not just again in the training and education and certification processes, what we call Phase I. Phase II is implementing the strategy for increasing utilization based on the training and education program. So there is, again, two phases, we train and certify physicians and while they are being trained and certified and as a prerequisite to training and certification we’re prioritizing the surgeons in terms of their ability to increase utilization. And that’s a strategic approach that requires follow-up work after the training and certification process. So we do think it will be a buildup of momentum throughout the year, we anticipate U.S. growth throughout the year, but accelerated growth and stronger growth in the second half of the year. In terms of competition, we believe the Medtronic as the number two domestic competitor. We believe that Medtronic is the target in terms of bipolar ablation technology and that most of our share gains would likely come from Medtronic bipolar users.

[Matt Dolan:]

Okay, great. And then maybe you could just touch on the Clip. It looks like it's kind of plateaued here at the – about a 1.4 million level on the last several quarters. Is that something with reorders that you think are coming in slow? Are you not seeing as many new accounts as you may have thought previously?

[David J. Drachman:]

Well, we think the Clip is still a very strong and we're encouraged by the platform. As you point out the trends have somewhat flattened out. We think the biggest opportunity to basically accelerate growth on the Clip is through the training program. During our training programs, we demonstrate our ancillary products which were used for the Synergy ablation system, which is cryo and our bipolar pen. We also demonstrate the AtriClip, but we think the AtriClip system should continue to increase as we increase our open ablation market, the AtriClip system will increase along with that. In addition, we mentioned the launch of a (inaudible) technology, which is a more highly featured product designed for minimally invasive and open use. That product should be released into the marketplace in the U.S. in the third quarter of this year, and we’ll provide another option and another means of going back to physicians with another platform technology for left atrial appendage exclusion. We also think that the stroke trial, that by initiating a stroke trial, that this is going to gain a buzz in momentum within cardiac surgery that will drive people towards Clip and Clip-like technologies.

[Matt Dolan:]

Okay, and if I could sneak one more in for Julie on the gross margin. Can you quantify what the manufacturing inefficiencies are? I know you’re going to build through the year, but what was – what is the optimized number based on what you did in Q4?

[Julie A. Piton:]

Yeah, I think ideally, especially all of our gross margin softening was driven by the inefficiencies, so I would stick with probably our historical range of 74% to 77%. Certainly, if international growth outpaces U.S., then that would be on – impacted by that on the lower end. But I would expect hopefully by the end of the year, we are back to those types of trends. Hello?

[Operator:]

And the next question comes from the line of Jason Mills, Canaccord.

[Jason R. Mills:]

Hi, Dave and Julie, thanks for taking the questions.

[David J. Drachman:]

Hi, Jason.

[Julie A. Piton:]

Good afternoon, Jason.

[Jason R. Mills:]

Good afternoon. Dave, I want to go back to your marketing strategy for Maze for – here in the U.S. And specifically, can you give us more color on specific events that you have planned in the first half of year? How that might impact your results as the year moves on? And you mentioned a focus on increased utilization; could you also talk about your plans for getting new hospitals onboard throughout the year?

[David J. Drachman:]

Sure. Good question, Jason. Well, for example, our strategy for training and education is not necessarily to do what we did at STS, which was to try to train 100 surgeons at the same time. But for example, we have a major university hospital, we have the EP that is going to present the ABLATE and ABLATE AF clinical results to the cardiac surgeons. At the same time, we have a world leading cardiac surgeon coming in to do the certification process with all the surgeons in the room at the same time. And during that process, we’re going to have a vetting discussion with this group of cardiac surgeons in terms of what their aims are for the program, for surgical AF ablation. So rather than just training and certifying people in large numbers, our goal is actually to do more customized approaches where we go out to centers, major centers, meet with all the physicians, may be capitalize on one of the surgeons there that might be a more experienced major surgeons, to bring in our educators, go through a certification program and then talk to them about what their goals and aims are for surgical AF ablation in the pre-operative settings. And maybe what their longer-term goals are for sole-therapy and hybrid like ablations. So at the end of those meetings, what we like to develop is basically a best practices approach to preoperative atrial fibrillation. So, if I go to doctor A, and I have a mitral valve and a cabbage that needs to be corrected, while Doctor A basically does the ablation and Doctor B does the same ablation. So we believe that standardization in terms best practices with individual groups and individual physicians is our better approach to capitalize on the training and education program than as trying to certify and train large numbers of surgeons at the same time. I think that was Phase I of your question?

[Jason R. Mills:]

It is. So if I would follow-up on that, I ask, so you mentioned 25% penetration into the target number of procedures done annually in the United States. So if you take the centers that you will be targeting through this customized approach, maybe talk about what your penetration is within those accounts, and where you think it could go over the next, say two years?

[David J. Drachman:]

Very interesting that you mentioned two years, but if you just take the 85,000 patients with preoperative AF, and if we’re at 25%, which let’s just say the math is 21,500 procedures; and we increase that by 500 basis points or 5%, we would be at basically 25,500 procedures, which would be an incremental increase over three year period of time or 4,000 procedures with an average selling price of $3000 per procedure. So you can see, as you incrementally increase penetration, you don’t necessarily need large percentage increases to drive significant revenue growth. That’s why we’re focused on quality, not quantity, that’s why we’re focused on aligning our sales organization around current users where we think there is more opportunity to take people from 30% utilization to 60% utilization, and as well as targeting high users of competitive technology with our experienced main surgeons, and where they understand the advantages of using on label AtriCure product.

[Jason R. Mills:]

Got it. So assuming you hold a share, which I’d presume you would expect to grow it, but assuming you’re holding it, based on that math, it would seem like you would expect or look to get somewhere in the range of 10% compound growth each year over the next two years with share gains something north of that in terms of your U.S. revenue base?

[David J. Drachman:]

I think in terms of being – in terms of the general discussion, I think you’re looking at the opportunity accurately.

[Jason R. Mills:]

Okay. Last question, and I’ll get back in queue. Outside the U.S., you mentioned geographic expansion into China, and outside of Southern Europe, Europe expecting to continue to do well. This year you had a phenomenal year, up 35% up of a relatively easy comp; in 2010, up 9%; in 2009, you grew fairly well off an easy comp as well. With a difficult comp here this year, and a strong performance in ’11 outside the U.S., can you give us some sort of quantifiable range we should be in, in terms of why you expect your international business to grow in 2012? Thanks, Dave, I’ll get back in queue.

[David J. Drachman:]

Hi, Jason, I think the simple answer to that would be, we would anticipate strong double-digit growth.

[Jason R. Mills:]

Thank you.

[David J. Drachman:]

Thank you.

[Operator:]

(Operator Instructions) The next question comes from the line of Jose Haresco, JMP Securities.

[Jose J. Haresco:]

Hi, guys, good afternoon.

[Julie A. Piton:]

Good afternoon, Jose.

[David J. Drachman:]

Hey, Jose.

[Jose J. Haresco:]

A question for you on the sales force, you mentioned that you had restructured it into nine territories. One, will you be adding to the headcount that you had and if you minus when we ended ’11 out, I mean if you’re adding to that? And two, in addition to just splitting them up geographically, are the changes in the way they’re working within those geographies because there is such a focus on training now and following up on the training?

[David J. Drachman:]

Excellent question, Jose. When we begin to prepare for the AF approval, we thought to ourselves and we ran some panels and discussed with physicians, how they would view being asked to go to training after they were using our products for some period of extended time, and we had a lot of mixed feedback. So what we did was we aligned our sales organization into nine regional rhythm management teams. Each rhythm management team has a leader. That leader is one of our best tenured AtriCure sales representatives. So the concept is that the sales representatives have support on a regional basis with one of the top sales professionals in our organization that basically talk to the surgeons at the different hospitals and plan for training and communicate the benefits of training to physicians and administrators in a more powerful way. We believe that some of our sales reps that are not quite as experienced might be moved out of the way. So we wanted to make sure that our top people were in front of our physicians especially early on in the process because as other sub-specialties as you know cardiac surgery is a small network. Once we begin to develop momentum and that the community of surgeons understands the advantages of basically standardizing approaches and best practices and the opportunity for AF and the opportunities for label is for cardiac surgery to basically develop an AF market. We think that the physicians are going to come along and really comply with the program and actually be enthusiastic about going for certification and looking to work with their partners and their groups and their hospital administrators on what the best approach to treating preoperative atrial fibrillation is as a group or a hospital system.

[Jose J. Haresco:]

Okay, thank you. Turning to the concept of training and emerging best practices out of a group that you are working with for a second; can you help us to understand a little bit more about what that timeline looks like, let’s say you are holding a training session on, call it January 1, best practices emerge out of that meeting, what happens after that, because a lot of times we start to see other committees have to get involved, particularly if you’re talking about bringing more technology, and that might have a price tag attached to it. Is this a – does it turn to a 60-day selling process for you guys at this point or is it a nine-day process, because it seems like it still requires a lot of hand-holding at that point to get it to where you want to go.

[David J. Drachman:]

I think the – there are several ways to look at that. When we come in and train a current user, automatically, we begin to re-ignite their interest in surgical ablation. So we anticipate that current users, especially the ones that are already bought into treating a reasonable percentage to a high percentage of their preoperative AF patients, that these current users will actually increase their utilization. This will be restimulated by the training program and by the interactions and by the vision of developing an AF program. In terms of people that are less experienced and less confident about integrating the procedure, they don’t require more of a Phase II training, and that may include proctoring. What we’ve done in many situation is, we’ve taken physicians at major institutions that are the maid surgeon, and we’ve developed relationships with that physician within the group, so that physician can actually educate and teach and proctor beyond the certification program and take responsibility for bringing the other surgeons in that practice of that group up to the same level of competency and confidence in integrating the ablation into the main surgical procedure. So that’s one way to handle it. Obviously, we also have expert proctors that we can bring in from the outside if the political dynamics don’t work well for an internal expert to continue on with a Phase II proctoring for less experienced surgeons. So just to summarize, the experienced surgeon in current user is going to basically come out of the certification process with a new found enthusiasm for treating atrial fibrillation more often than that. And the surgeon that isn’t treating it on a very high percentage basis, is likely then it requires some additional training and follow-up, which would likely include proctoring and some preceptorship before they actually really begin to gain enough confidence to integrate the surgical ablation into their procedures.

[Jose J. Haresco:]

Okay, thank you. And I guess, I’m sorry if I missed this, but what was your headcount in sales and marketing at the end of ’11 and where would you expect it to be at the end of ’12?

[David J. Drachman:]

Well, the field group was 62, and we’re at 58 right now.

[Jose J. Haresco:]

Okay, got it. And would you expect to grow that organically, or it would be – maybe study for the rest of the year?

[David J. Drachman:]

Well, we’re obviously very cautious about aligning revenues with expenses. What we try to do with our current full headcount is align around the current users because we've got 18 months to train those current users. So, we try to align our resources around current users and high-volume competitive accounts. And as we get further into the process, we’ll have a better idea of what we need whether that’s additional sales reps, additional clinical support people or additional training resources. And right now we’re a little bit too early to say what type of sales and marketing skill set would best benefit our utilization objectives and sales growth objectives.

[Jose J. Haresco:]

Okay. Great, thank you very much.

[David J. Drachman:]

Thank you.

[Julie A. Piton:]

Okay.

[Operator:]

The next question comes from the line of Charley Jones, Barrington Research.

[Charley R. Jones:]

Hi, thanks for taking my questions.

[David J. Drachman:]

Hey, Charley.

[Julie A. Piton:]

Hey, Charley.

[Charley R. Jones:]

So, I wanted to kind of go back to Jason’s questions earlier about trying to figure out what kind of growth opportunities there are from the new label. And I wanted to try and slice it a little bit of a different way. I guess I was a little bit surprised to hear about 10% growth because that implies, kind of 5% market growth if you’re growing 10% and assuming Medtronic can’t take share without an approval. So, curious if you are comfortable at those growth rates you talked about? But then also, just curious what you’ve learned about what types of procedures surgeons are doing? Because we never have understood why there is only 20%, 25% of procedures being done given the efficacy and given the chest is open and so I’m wondering if you could talk a little bit about the types of procedures that some doctors do relative to maybe the 80-20 rule, the 20% that don’t as many procedures? And you talked about some these more complicated procedures that you need to do some training on. And how big of a number is that and what kind of opportunity is there to grow into that procedure? Is it kind of somewhat kept to the university centers? And again, trying to get back to this 10% number, it seems kind of low to me.

[David J. Drachman:]

Okay, Charley, I’m not sure exactly you’re opening comments about how you characterize 5% versus 10%.

[Charley R. Jones:]

Well, it’s – I think to Jason comments, you said about 4,000 procedures and about 10% growth, and I was just assuming you’re going to get a lot of the market growth given your approval and the lack of Medtronic’s approval. And so I guess, I’m wondering is that 10% market growth you’re assuming over the next couple of years per year or is that 10% for AtriCure on the open side?

[David J. Drachman:]

Okay, I think I understand where you are coming from. In terms of the overall 10%, that was a number I think Jason offered up in terms of a number that he basically came to based on our looking at increasing levels of penetration, and we more or less jointly agreed that that’s a reasonable approach and a reasonable way to look at it. In terms of these more difficult procedures and the types of procedures that people are performing, well, the growth in the number of cardiac surgery procedures has not only been impacted by interventional cardiology advancements, but it’s also been impacted to some degree by the fact that patients between 54 and 65, the demographics have basically slowed. There is very little growth between the ages of 54 and 65. The growth between 65 and 75 has increased significantly. So the demographics of what we see in the operating room are typically people that are older, that have multiple, not just cardiovascular comorbidities, but are sicker in general. The types of operations for example that you saw in the ABLATE file, we had – 20% of the patients had double valve procedures, which is not something you would necessarily have seen 10 or 15 years ago. So the patients are actually very old in nature, our ABLATE population was on an average 70 years old with a preoperative duration of atrial fibrillation of almost four years, and they have left atrial size of 6 centimeters. So these are typically sick patients. And the concept of getting surgeons that hasn’t been trained or doesn’t come from the training program where they performed a lot of Maze procedures to basically integrate the surgical ablation into a relatively high risk surgical [cannulae] takes another level of training. And as you stop and think about it, part of your challenge is, how do you choreograph the procedure? If I’m doing a cabbage, I choreograph the procedure differently than if I’m doing a mitral valve or a mitral valve and an aortic valve. So the steps and the procedure change depending upon what the baseline operation is. And that’s the type of training and experience that we need to share with the surgeons that are not currently performing procedures which there are many cardiac surgeons out there that don’t see preoperative atrial fibrillation at all. And there are a high percentage of surgeons that treat preoperative atrial fibrillation less than 20% of the time. We’ve done some surveys at some leading centers, where you have the top maze surgeon is treating almost 90% of its preoperative AF patients if the surgeon that – in this experienced Maze group that treats the least percentages down around the 10% range. So there is a wide range of confidence levels based on previous experience in training, and what I'm suggesting is that the surgeons that have little experience in treating pre-operative atrial fibrillations will require follow-up proctoring and follow-up trainings which can come from inside the group or from outside the group. What I'm also suggesting is that, we'll get an immediate stimulus in terms of utilization just by going through the certification process in those physicians for example that have adoption rates that are in the 50% to 70% range. Maybe they’ll become surgeons that treat atrial fibrillations 80% to 90% of the time. So there's again a wide range of level of experiences and what we believe is that, we need to provide the programmic approach that walks into a hospital and says, this surgical group, what are your aims and goals for preoperative AF treatment. And how do we work together to get everybody treating the same patients with a similar ablation treatment.

[Charley R. Jones:]

That's extremely helpful. I guess, just to make sure I do understand it, I've always thought of minimally invasive as being a little bit more complicated not necessarily done by your local surgeon. So, but I guess the way I've heard you characterize yield for surgical approach I would think that the majority of surgeons could complete the large majority of procedures that are currently being done at that 90% hospital for example. It's not like 75% or 50% of the procedures out there are just too complicated for the more – the average surgeon to do?

[David J. Drachman:]

I think you're exactly right. I think, no matter how much we were trained, for example, minimally invasive thoracoscopic surgeons there is still going to be a fairly high percentage of surgeons that really wouldn’t be able to be very confident at performing a minimally invasive thoracoscopic ablation procedure with high safety and high efficacy. So I think that’s true. I think what’s also true is that, a very high percentage of cardiac surgeons can learn to integrate the (inaudible) to an open procedure, but it requires training, and if I have experience, and I’m come from an experienced center then the training threshold is much lower. If I hasn’t had experience and I’m currently not doing the procedure for combination of whatever reasons, then it’s going to require more than just a didactic practicum training and a certificate we get those surgeons to be more comfortable in terms of being able to integrate ablation into their patients. But I think the key is to go to the surgical community, and to a bi-center and meet with the groups and individual surgeons and develop goals and aims for treating preoperative atrial fibrillation, and to talk to the key surgeons. And we just came back from a very – a meeting of the top surgeons, it’s a fairly private meeting of top cardiac surgeons, and there were series of the top people in the industry that attended, who were invited, we explained our training plan in terms of creating standardization, best practices, and working with centers and physicians, come up to a certain standard that’s in line with their loops, goals and aims. And we got very high marks for this type of strategy, and I think the – these winning cardiac surgeons profits would be a very well accepted approach, and we’re very supportive of it. So I think we’re on the right track. We just have a lot of work to do.

[Charley R. Jones:]

It sounds very good, thanks. I think, I’m – we’re getting close to the end of the questions, I did have a couple of follow-ups, I’m just going to cruise through here. So wondering if you could give us a little bit more detail on this new clip, it sounds like the new design is not complete, when do you expect that to complete – be complete, and do you need that to be able to get the IDE approved? Could you explain a little bit more about the 510(k) process for the next generation clip, a little bit confused about that? And then, just wanted to make sure there were no new product committees necessary for the synergy system with its approval, I would assume that’s not the case, but just want to sure there is no kind of strange hiccups at certain hospitals relative to pricing reimbursement or getting the product, and even though that’s already been there?

[David J. Drachman:]

Well, in terms of second question first, if the products are already on the shelf, the fact the labeling is updated, we haven’t seen any challenges with that.

[Charley R. Jones:]

Any changes on reimbursement or pricing here?

[David J. Drachman:]

No. No changes on reimbursement or pricing in the current users, it’s been basically where the training, where we train current users, what we’ve seen is, once you get into more experience current users, go back and they’re re-enthused and typically do more procedures, and the less experienced physicians, we need to have a Phase II plan in place to get them more confident in the adoption of integrating the technology into their procedures. In terms of the [Bova 2] what we call Bova 2 which is a new generation AtriClip platform, designed for both open and minimally invasive procedures. This is a system that basically has full range motion at the end-effector, and you can lock it into position. The shaft is designed uniquely for minimally invasive and open procedures. Our current Bova 1 doesn't perform as well in a minimally invasive setting. So we design Bova 2 to overcome some in limitations of Bova 2 in minimally invasive procedures, but also to be an open product, so that we could take advantage of this technology in open procedures. It can be used with a grasper or robotic arm, and the acceptance at least some of the cadaver lab work that we’ve done with a large number of physicians have been a – this is a significant improvement in the minimally invasive thoracoscopic approach, and also as advantageous in open cases as well. So we’re excited about that product. Now, the IDE for the stroke feasibility trial is already approved, but it’s approved with the Bova 1. So our plan is to basically take the current approval, submit it to the IRBs, get IRB approvals, contracts and CMS approvals all in place, while we wait for the Bova 2 to be available for human use. We anticipate the Bova 2 IDE supplement to go in mid-year this year and for the 510(k), it will be approved some time during the third quarter. So I hope that answers your questions, and be happy to…

[Charley R. Jones:]

Yeah, that’s great, Dave, and sorry for my convoluted first question. Thanks a lot.

[David J. Drachman:]

Sure.

[Operator:]

And the next question comes from the line of Jason Mills, Canaccord.

[Jason R. Mills:]

Thanks for taking my follow-up, Dave. Actually a question for Julie, just to make sure, I’ve got your guidance for SG&A right for 2010, Julie. Could you go over that again? I thought I heard you say an incremental increase of $750,000, did I hear that right?

[Julie A. Piton:]

On the SG&A side, just related to the training, so we had repeat questions about what the training, and the post-approval study would cost, and so I just wanted to be responsive to that. So the training program, kind of the all-in cost is roughly $1.5 million, and about half of that will be incremental year-over-year. And so that, that’s not our total expected increase in SG&A, it’s just really the cost of that program.

[Jason R. Mills:]

Okay. So as we think about total SG&A, would you expect, given that incremental amount of training that you’re spending on SG&A as a percentage of your total revenue will increase modestly here in 2012?

[Julie A. Piton:]

Yeah, outside of that program, we don’t have any other major initiatives that I would anticipate funding. As Dave commented earlier, we’ll certainly be opportunistic in terms of adding headcount as appropriate once we have a clear vision of how the business performs particularly here, domestically. So certainly that would be a modification to that, should we have that come together.

[Jason R. Mills:]

Right. So just I’ve got it. So you’re not expecting this year to be a year of leverage to the SG&A line either?

[Julie A. Piton:]

Well, the overall OpEx line, I don’t expect substantial leverage, but I think you’ll see some modest leverage or flattening of leverage year-over-year. Remember, we also have R&D expenses which I commented, I expected to ramp $1.5 million to $2 million.

[Jason R. Mills:]

Right. So that equates to between on where you’re in revenue range, $70 million, let’s say just for an example sake, it would be around 20% of your revenue. SG&A, if we’re sort of modeling it after the fourth quarter, again assuming some of these training expenses, if you are in the $44 million, $45 million range for the year will that be far off?

[Julie A. Piton:]

Yeah, we haven’t given any guidance for total expenses, I think, the earlier comments would be as much as, as we provided at this time, Jason.

[Jason R. Mills:]

Okay. Thanks, Julie.

[Julie A. Piton:]

Thank you.

[Operator:]

There are no more questions at this time.

[David J. Drachman:]

Well, thank you very much for joining the call. We look forward to talking again on our first quarter earnings call. Thank you so much.

[Operator:]

Ladies and gentlemen, thank you again for your participation. This concludes today’s conference. You may now disconnect and have a great day.