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Q4 2012 · Earnings Call Transcript

Feb 28, 2013

Executives

Lynn Pieper – IR Mike Carrel – President and CEO Andy Wade – VP and CFO

Analysts

Tom Gunderson – Piper Jaffray Jeff – Canaccord Genuity Danielle Antalfy – Leerink Swann Chris Luis – ROTH Capital Partner

Operator

Good afternoon and welcome to AtriCure’s Fourth Quarter 2012 Earnings Conference Call. My name is Derrick and I’ll be your operator for today.

At this time, all participants is in a listen-only mode. We will facilitate the question-and-answer session towards the end of the conference.

As a reminder, this conference is being recorded for replay purposes. I would now like to turn the call over to Lynn Pieper, AtriCure Investor Relations Consultant from Westwicke Partners for few introductory comments.

Please proceed.

Lynn Pieper

Thank you, Derrick. By now, you should have received a copy of the earnings press release.

If you’ve not received a copy, please call 513-755-4136 to have one e-mailed to you. Before we begin today, let me remind you that the company’s remarks 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. 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 metrics is included in our press release, which is available on our website.

I’d like to remind everyone on the call today 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 to train doctors for the surgical treatment of AF or stroke reduction unless the product is still indicated.

These restrictions do not prevent doctors from choosing to use the products for their treatment of AF or stroke reduction will prevent AtriCure for engaging in sales and marketing efforts to focus only on the general attributes of the products for the current cleared usage. AtriCure educates and trains doctors in the proper use of its products and related technologies, including for the treatment of AF in accordance with the product specified indication.

With that I’d like to turn the call over to Mike Carrel, President and Chief Executive Officer of AtriCure. Mike.

Mike Carrel

Thank you, Lynn. Good afternoon and welcome to AtriCure’s fourth quarter and year-end 2012 conference call.

Joining me today is Andy wade, our Chief Financial Officer. On today’s call, I’ll provide review of business trends, our strategy for capitalizing on our AF approval, new product developments and an update on our clinical trial progress.

Andy will provide more detail on our fourth quarter financial results and will also provide our outlook for 2013. As many of you know, I joined AtriCure in early November and spent the past several months working closely with employees and visiting customers to define the strategic and operating priorities of the company.

Specifically, I have visited over 75 customers met and received feedback from almost our entire organization attended over five key trenches, many of our educational sessions and spent time with our clinical consultants. During this time we completed our 2013 growth oriented budgeting strategy.

I have learned a great deal and are more excited today than when I joined. I continue to be impressed by the resiliency of this team and my first impressions are the same as what I learned during my diligence.

We have a highly talented group of people including employees and physicians and alike who are all committed to our growth and success. We have a great brand and even better customer service ethic that permute every aspect of the company.

When you combine all of this with our FDA label, significant IP, exceptional products, first class sales force and now a strong balance sheet, we are well positioned to accelerate our growth in the upcoming years. Our foundation is strong.

Now, we need to invest in key areas and execute. In the mist of the all the leadership changes, the company stay true to its mission and had many accomplishments during 2012, including growing the business more than 9% and international growing 14%, closing the year strong at 18.4 million in fourth quarter revenue or 9.5% year-over-year growth building momentum going into 2013, training nearly 800 physicians on the Maze IV procedure representing roughly 400 sites.

Introducing key products including the BOA Pro from minimally invasive clip in the U.S. and the Coolrail re-launch including a 5, 10-K clearance for both these products.

Starting enrollment in the stage DEEP AF feasibility studies focused on a hybrid approach, receiving approval for the FDA ABLATE post-approval study, growing our Cryo sales over 50% to 4500 probes in gaining significant share, and finally, achieving nearly 80 competitive conversions. As many of you know, we’re committed to the disciplined growth and making our business simple to understand.

I believe in this market and under my leadership, we’ll be focused on getting AtriCure to the Broadway recognized as a dominant provider of technologies and solutions for the treatment of atrial fibrillation and left atrial appendage management for strong production. As such, we’ll anchor our business around the following five key strategic competitors.

One, increase penetration in market share in concomitant AF space, two, establish Left atrial appendage management and AtriClip as a standard of care in conventional cardiac surgery. Three, accelerate the growth of sole-therapy AF or MIS and physician AtriCure, the AtriCure procedure is the industry standard.

Four, established sole-therapy Left Atrial Appendage AtriClip market, and finally five, increased AtriCure’s global footprint. In order to be successful in each of these areas mentioned we need to be as a forefront our physician education and training, established reimbursement expertise and proactive activity awareness, accelerate our new product development efforts, continue our focus and dedication to the clinical science and it will line it with our commercial programs and build better EP and cardiology partnerships.

Now turning to some business trends. We are pleased to report that in the fourth quarter U.S.

open heart revenue, including AtriClip, was up 18% compared to the same period a year ago. We believe that this is evidence of our investments and strategic priorities are building momentum and resulting in sustained growth and opportunities.

In the U.S., procedure trends have remained generally stable throughout the fourth quarter, despite the typical seasonal slowdown in December. And we continue to experience strong growth trends from our international markets, which were up 10% versus prior year on a constant currency basis.

We’re also continuing to capitalize on our investments to support of our AF approval through education activities designed to increase awareness and improve patient outcomes. We initiated our first training and certification event a little over year ago.

And to date, we have trained nearly 800 cardiac surgeons, up from the 569 surgeons we’ve reported last quarter. It is important to point out that what actually matters isn’t the number of surgeons trained, but rather that the sites in which they are affiliated are certified and enabled to continue buying product from us.

As of now, roughly 80% of our customer base is certified and we are continuing to focus on the remaining sites which we expect to be certified over the course of this year. We are successfully expanding program, which as anticipated is resulting in increased utilization, competitive share gains and cross-selling opportunities.

Training levels and conversion of competitive accounts is providing in-roads into new hospitals which is bolstering our growth for the open procedures and clip sales. We expect this to continue through 2013 as we look to accelerate growth through continued and more focused efforts on education, marketing and the development of a strong referral base.

Clip sale in the U.S. posted growth of 34% and reached 1.9 million in revenue in the fourth quarter.

Our customers are increasingly interested in treated – and with that our increasing their acceptance of our clip. In the fourth quarter we expanded our limited launch to four commercial release of our Next Gen articulating robot friendly clip applier called the BOA Pro.

As expected it is capturing a meaningful price increased. MIS sales in the U.S.

were down 8% in the fourth quarter, keeping with the trend we have seen over the past several quarters. We embarked on several efforts to bring this growth rate back up over the long term.

These activities are centered on the acceleration of our DEEP clinical trial and include ongoing clinical support, increasing training and practice in product development. We are beginning to invest in the expansion of our feasibility study to be ready for a full pivotal trial.

In order to serve, we need to significantly expand number of surgeons that are trained in this procedure throughout the U.S. as such we are establishing training centers and centers of excellence in the U.S.

as well as our crossing bonus program with master. Through this program, we are applying clinicians overseas to train as a team.

And finally we are focused on product development to improve our technology and simplify the MIS approach. We recognized that many of these activities are long-term in nature and will take time to develop and implement.

In the near term, we don’t see growth coming out of the MIS platform. Over the longer term, with our dedicated focus on clinical support and science, education and innovation, we remain optimistic that we’ll be successful in developing this market.

Internationally, we are making great strides. We are expanding our international sales coverage where we have direct sales and particularly in Germany.

Additionally, we are converting the UK from a distributor model to direct. We have added head count in the areas of business development, international marketing and we’re adding distributors and support in Eastern European countries.

Operationally, we embarked on several key initiatives in the fourth quarter into positioning AtriCure for growth. First, as announced in mid January, we completed the financing and broadened shareholder base and brought $27 million in net proceeds of the company.

This was a major milestone. With capital structure, we are able to turn more of our attention to executing our commercial strategy.

Secondly, we announced three key promotions. Andy Wade was promoted from VP of Finance to Chief Financial Officer; Andy Wade has over 15 year of financial experience and has spent past five years here at AtriCure building out our finance and accounting team.

I have the utmost confidence in them. And turning our focus to our commercial team, we promoted Doug Seith to Senior Vice President of sales and marketing.

Doug is responsible for further strengthening our commercial execution and marketing development in conjunction with expanding sales. Doug has over 25 years of experience in cardiac surgery, cardiology and general surgery sales, the last nine of which he had been here at AtriCure.

We also promoted Mike Rogge to Vice President Marketing. And under his expanded responsibility, he will be focused on market development activities, building a product management function and physical education programs that reach – to redefine target markets.

Mike has over 22 years of medical device experience, the past seven with AtriCure. In addition to these promotions, we’re also beginning to expand our commercial team and have recently added a Director of International Marketing and a Director of Full Development here in the U.S.

Both of these individuals have 25 plus years of experience at major medical device technology companies with a particular focus on AF. Lastly, we’re pleased to announce Dr.

Jim Cox has joined AtriCure to guide us in the development and execution of a world class professional training and education program. It’s hard to quantify what it means towards the long side the inventor of the Maze procedure, which has been responsible for improving the life’s of hundreds of thousands of patients.

Dr. Cox believes that with our FDA approval and post approval study, we’re in an excellent position to drive awareness, education and treatment of AF patients and we agreed.

We believe that Dr. Cox has primary area to contribution AtriCure will include.

One, the assistance in developing a world class physician training and education program, two, helping to assemble and coordinate our medical advisory boards and committees and three working with regulatory and clinical to help guide protocols, contribute to communication with the FDA and to help, develop and justify our clinical trials. I have say Dr.

Cox will be very busy working to ensure that more patients are treated with improved outcomes. Moving to an update on our clinical programs.

In an effort to bring more clinical knowledge internally and better monitor cost we are building up our internal clinical research operations and continue to leverage and work with our outside consulting firm in key strategic areas. As a result, I am pleased to announce that we’ve recently added Director of Clinical Operations and seasoned individual with over 20 years of clinical trial experience.

Additionally, we continue to invest in clinical science and FDA approvals. In October, we started enrolling in our ABLATE post approval study or PAS.

This landmark three year 350 patients study is intended to build additional evidence on the safety, efficacy and long-term durability of the AtriCure Maze IV concomitant treatment for AF using AtriCure’s proprietary surgical devices. The study has been led by Dr.

Patrick McCarthy, Chief of Cardiac Surgery in Northwestern University, and includes almost 50 sites around the U.S. who will be enrolling patients.

As of today we have 16 sites up and running within additional 25 which are going through final IRB approvals on processors. Including the patients from ABLATE AF we now had approximately 100 patients enrolled and expect to accelerate the enrollment in the back half of the year.

The study supports our goal to increase penetration in market share in the concomitant AF market. Moving to the Staged DEEP AF feasibility trial, As Mike Hooven discussed on the call – on the last call we initiate enrollment in the DEEP AF feasibility study in September at two sites.

We now have four of six sites up and running and have enrolled 13 of the 30 patients today. This study supports our goal of accelerating our growth for sole-therapy and working closely with EPs as is procedure.

We do not yet have results to reports we are pleased that the progress and look forward to providing an update as we have more data. Now on to the ABLATE II, ABLATE II was design to get approval for the right lateral thoracotomy sole-therapy approach.

We have decided to cancel this study in favor of putting our efforts behind the DEEP study noted earlier and yet to be determined stroke AtriClip study. We will make a final decision on these additional clinical studies during fiscal 2013.

In the meantime, we will continue to support key strategic research in the both the U.S. and Europe.

In summary, I’m excited about the opportunity at AtriCure and in the past 100 days we have raised the necessary capital to support our growth made several key hires to support our initiatives, continue to make progress on our clinical studies and physician education. I’ll now turn the call over Andy Wade, our Chief Financial Officer to provide more detail on fourth quarter financial results and provide guidance for 2013.

Andy Wade

Thanks Mike, for the fourth quarter of 2012, revenue increase 9.5% to 18.4 million. Revenue from product sales in the U.S.

was $13.7 million, an increase of 10.2% from the fourth quarter of 2011. Revenue from open chest oblation related product sales in the U.S increased by approximately $1.1 million to 8.4 million with the decrease in sales of products used in minimally invasive procedures of approximately 300,000 to 3.4 million.

U.S. sales of the AtriClip system during the fourth quarter of 2012 were $1.9 million as compared to $1.4 million for the fourth quarter of 2011.

International revenue grew 7.8% on a GAAP basis and 10.1% on the constant currency basis as compared to the fourth quarter of 2011, up to 4.7 million. The increase in the international revenue was driven primarily by growth in Europe.

Consistent with prior quarters, we experienced a modest decline in ASPs in the fourth quarter. Gross margin for the fourth quarter of 2012 was 70.8% as compared with the 70% for the fourth quarter of 2011 and 71.6% for the third quarter of 2012.

Similar to what we have described for earlier quarters, the year-over-year change in gross margin was primarily the result of investment and manufacturing and quality systems to transition and maintain the manufacturing of PMA-approved product to support our expanding operations. Along with the small portion driven by the continued increase and the mix of international sales and an increase in the placement of capital equipment.

We also took a $225,000 charge to our inventory reserve, equal to approximately 125 basis point on gross margin. We continue to be highly focused on increasing efficiencies and reducing product cost.

Operating expenses increased 10.6% or approximately 1.4 million from 13.4 million for the fourth quarter of 2011 to 14.9 million for the fourth quarter of 2012. Sequentially, operating expenses were up $800,000.

Research and development expenses what excludes clinical activities were $3 million for the fourth quarter of both 2012 and 2011. Note that in the fourth quarter of 2011, we recorded a $300,000 gain on the sale of a patent as an offset to R&D expense.

Year-over-year, this gain is primarily offset by a significant decrease in consulting expense from the fourth quarter of 2011 related to the preparation for the FDA panel meeting held last year. We expect clinical cost to increase modestly in support of our key clinical initiatives, mainly the post approval study in DEEP AF along with the continued investment in our product pipeline.

SG&A increased approximately $1.4 million, due to increases in selling, marketing and training cost along with administrative expenses. Our operating loss for the quarter was $1.9 million, as compared with approximately $1.7 million for the fourth quarter of 2011.

Our adjusted EBITDA loss was approximately $945,000 compared to $575,000 for the fourth quarter of 2011. Our net loss per share was $0.12 for the fourth quarter of 2012 compared to $0.13 for the fourth quarter of 2011.

Turning to the full year, worldwide revenue was $70.2 million, a gap increase of 9.1% or $5.8 million over 2011. On a constant currency basis, growth was 10.3%.

For the U.S. sales grew 7.5% to $52.6 million.

U.S. open revenue was strong growing at 12.6% to $32.9 million.

Cryoablation products which are included as a component of open sales performed very well growing over 50%. U.S.

sales of products used in minimally invasive procedures declined 10.1% from 2011 to $12.7 million. U.S.

sale of AtriClip products grew 25.9% to $7 million. International revenue grew 14% on a GAAP basis and 18.9 % on a constant currency basis to $17.6 million.

Gross margin was 71.2% for 2012 compared to 73% for 2011. EPS was a loss of $0.47 for 2012 compared to $0.35 for 2011, and our adjusted EBITDA loss was $1.8 million for 2012 compared to income of $131,000 for 2011.

Note that 2012 included approximately $1.6 million of expense or $0.10 per share related the departure of the former CEO and CFO. Now turning to a few balance sheet items.

We ended the quarter in year with $12 million in cash, cash equivalents and investments. Additionally, we had approximately $5 million of borrowing capacity under the revolving portion of our credit facility.

As a reminder in mid January we completed a stock offering of approximately 4 million shares which generated net proceed of $27.1 million. We believe our current cash position will support the execution of our strategic plan.

Lastly, we would like to provide the following guidance for 2013. We anticipate top line growth of approximately 9% to 11% year-over-year on a GAAP basis, or revenues of $76.5 million to $78 million.

We anticipate gross margin to be in the 70% to 72% range for the year, which implies a modest price decline consistent with what we have been seeing. Notable we will be including the medical device excise tax as a component of cost of goods sold and we expect this tax to impact our gross margin by approximately 100 to 125 basis points or $800,000 to $1 million.

We do not anticipate being able to pass along this cost to our end customer. We expect R&D to be in the 17% to 18% of sales range and SG&A to be roughly 64% to 66% of sales in 2013, a slight increase in spending levels versus 2012.

We anticipate increase spending related to previously described activities including clinical science, training and education and international expansion. We expect adjusted EBITDA for 2013 to be a loss in the range of three to $5 million.

Lastly, we anticipate an increased in cash burn in 2013 versus 2012 due to additional investments in operating expense to fund commercial development and product development activities and international expansion along with working capital and CapEx needs to support our growth strategy. At this point, I would like to turn the call back to Mike for closing comment.

Michael H. Carrel, President and Chief Executive Officer Thank you, Andy.

Overall, we are pleased with the fourth quarter performance. We expect growth in 2013 to be led by ongoing success in training and education initiatives which is driving conversion at competitive accounts at an accelerating pace.

In addition, we are investing in our clinical and commercial efforts to further accelerate this growth sustainably. As the only company in the world with an FDA approval to treat the more serious forms atrial fibrillation we are committed to advancing the field.

Coming out of 2012, the strongest industry movement that we are seeing indicates that surgeons are warming up to treating atrial fibrillation and AtriCure is emerging as an education leader on this endeavor. With our recently completed financing in January, we have strengthened our balance sheet successfully build and grow our business.

We are transforming AtriCure into commercially focused organization with a clear eye towards accelerating our growth, leveraging our operating structure and eventually driving profitability. I look forward to updating on our progress and we’ll now open the call to questions.

Operator

(Operator Instructions). For the interest of time, please limit yourself to one question and one follow-up.

Our first question is coming from the line of Tom Gunderson, Piper Jaffray.

Tom Gunderson – Piper Jaffray

Hi. Good afternoon.

Mike Carrel

Hi, Tom.

Tom Gunderson – Piper Jaffray

So, Andy, just a quick clarification on adjusted EBITDA, that’s GAAP EBITDA and then including stock comp as well?

Andy Wade

That’s right.

Tom Gunderson – Piper Jaffray

Okay. And it looks like at $945,000 loss for the quarter and 3 to 5 million projection for the 2013 year, it’s pretty close to the run rate that you ran in the fourth quarter as a midpoint.

I mean that’s the way we’re going to – I’m looking at modeling here and the modeling will be pretty close to what you did in the fourth quarter?

Andy Wade

Right.

Tom Gunderson – Piper Jaffray

Okay. Thanks.

And then Mike, my goodness! 75 customers and 5 trade shows and four months plus meeting all of the employees, what was the one overwriting trend, what was sort of – did you get any ah-ha moments where after-tucking to 50 customers, you knew what the next 25 are going to say as far as what you needed to do to maybe help them a little bit and jazz sales at the same time?

Mike Carrel

Two things, let’s say, not only they are ah-ha moment, I think they are more confirming statements, one was that, continue to invest in educating and physician education was by far came across from every single person that I met across the board, not just here in the U.S. but globally.

Number two was to continue to focus and actually lead the filed from a clinical science standpoint. Continue to invest in the right types of trials and make sure that we’re not – we’re spending our money where we’re going to actually get approval that we can take advantage of.

And what I was most impress from the customers, as they want us to be successful long-term, because they believe that is important for the field more than anything else. And that was I’d say probably the biggest movement, how much they really embrace this company for success, not for their own personal success, but truly for eventually patient outcomes and having good technologies in the market.

Tom Gunderson – Piper Jaffray

Got it. Thank you guys.

Operator

The next question is from the line of Jason Mills, Canaccord Genuity.

Jeff – Canaccord Genuity

Hi, guys. This is Jeff coming in for Jason.

Thanks for taking the questions. Mike, my calculation that U.S.

open heart ablation revenue excluding AtriClip was low in the second half of 2012 versus the first half we would have expected open heart revenues in the U.S. to ramp as its 2012 given increasing number trained centers.

So could you give us a little more color explaining the reason for this trend? And what will improve the slope of this sequential curve?

Mike Carrel

I mean the key growth area and I believe the open market is actually probably the most exciting near-term – it is the most exciting near-term market for us. We believe that that market is where you’re going to see the growth in 2013.

If you look at over the year, we’re about 13% growth on that open side. And when I’m looking at it overall the business I truly believe that’s really where we’re going to see.

Education is critical towards that. We are continuing to see competitive conversions as I briefly mentioned.

We had 15 competitive conversions in the most recent quarters. Those conversions take time to actually to drive to revenue though.

They don’t just convert over night and tomorrow getting revenue. They need to get bit of inventory.

They might be using they need to get trained on our product and up in running. They need to get close with our reps, so they are actually bring us new cases, and that just take time.

And I believe there are continued focus on that education is going to be critical. People are switching now because we have an advantage.

We got the only FDA approved product which matters. A product have proven efficacy and we are the one doing the certification course.

And you combined those three things together and we are getting the exposure, it’s just – it’s not going happen overnight.

Jeff – Canaccord Genuity

Great. Very helpful.

Just a couple of housekeeping questions. With regard to the guidance, what are your expectations for U.S.

and international growth in that 9% to 11% range?

Mike Carrel

We’ve not given specific guidance by area. We are obviously investing a tremendous amount in international.

We think the international can go at a faster pace than it did this year for sure. And so on the U.S., I believe we are going to continue to seek strong growth on the open side and on the open clip, and hopefully getting on the track back on the MIS side towards stabilization on that throughout the year.

Operator

The next question is coming from line of Danielle Antalfy from Leerink Swann.

Danielle Antalfy – Leerink Swann

Hi. Good afternoon, guys.

Thanks so much for taking the question. If I could start and push you a little bit on the long-term guidance, you are reinvesting heavily.

Can you talk about what you see is the keys to getting you back up towards that 15% range from a top line growth perspective, the puts and takes there. And also on 2013 guidance what are the puts and take that get you to the high end of the range versus the 11% versus the 9%.

Mike Carrel

The puts and take if you break down on our business really simply on the open concomitant side that’s where we are seeing the short term 2013 and ‘14 that we continue to see growth. I do believe this education part from that we have is going to continue to show an acceleration on that side in the U.S.

market. On top of that we are starting to see more and more clips being applied, one more doing that.

We don’t have specific statistics around the percentage of open cases that we have that are tied to that. But we are seeing a nice increase; it was 265 growth in the U.S.

market last year on the clip side. So I believe those two things are really going to begin to start to trend to get us towards that 15% that we talked in the outer years.

Combined that with from an MIS standpoint as we get in to the trials and we start moving forward with that and getting more sites up and running in surgeon trend, we’ll begin to stabilize that business and that should begin to kind of show to get – and that applies to both 2013 and to the future years. If we get that up to kind of base line, you’ll begin to see us at the top end of the range, if you just kind of do the math on it, and then in the longer term obviously hopefully getting that back to on the growth pad.

Danielle Antalfy – Leerink Swann

Okay. That’s helpful.

And then do did just do this cash raise, how do we think about cash position to get you to profitability, were you have to go back to the market or guys still comfortable where you are at this point?

Mike Carrel

We feel very comfortable to where are right now.

Danielle Antalfy – Leerink Swann

Okay. Great.

Thanks so much guys.

Operator

Your next question is coming from the line Matt Dolan, ROTH Capital Partner.

Chris Luis – ROTH Capital Partner

Hi, guys. This is Chris Luis on line for Matt.

Thanks for taking the questions.

Mike Carrel

Hi, Chris.

Chris Luis – ROTH Capital Partner

You’ve touched on international expansion plans for the year, but can you provide some more detail on the progress you’ve made so far internationally perhaps where you are adding some of the reps and how many have been added so far and how many you expect to add by year-end?

Mike Carrel

Sure. So, a couple of things on the international front.

The first thing we did in the international front was actually add a little more infrastructure, so we brought in international marketing manager to help us actually understand reimbursement and the appropriate business plan to go after the different countries. On top of that we actually added somebody in the service levels that can provide better service to both our distributors and on the direct basis.

We’re beginning to recruit and expand coverage very specifically in Germany where we currently had about two reps, we anticipate that to grow at least double over the course of the year and in some other areas as well. We’re converting our UK from a distributorship into a direct model.

That will happen mid to end of year. And so we’re making progress on all of those fronts on the European continent, specifically in Asia what we’re doing is we’re renegotiating our contract with our distributor to add additional products and to get those approved.

That won’t have much of an impact on 2013, but we do see that ‘14 and ‘15 having some impact on our growth rates and working very closely with the distributor to get those products into the market and to get some more growth out of the Japanese market place, where we have a dominant share today just on the clamps. And then in China, we have a very good distributor that we’re working with and I’ll be visiting there in the May timeframe to talk to that distributor about growth plans and they’re going to be doing to kind of expand their sales force to enable us to grow our products there as well.

Chris Luis – ROTH Capital Partner

Okay. Thanks.

That’s helpful. And then with the number that the investment needs you’ve highlighted on the call, how should we expect that increased operating spend trend throughout the year given the different investment?

Mike Carrel

I think it will be pretty – we’re not going to hire everybody upfront. We did hire some of the key people pretty quickly in January, February, so some of them are expensive individuals let’s just say at the beginning of the year, but we do have hiring in that 25 to 30 plus range throughout the year; it will be throughout the year, it’s not all going to be in the first quarter.

Chris Luis – ROTH Capital Partner

Okay. And then in terms of the gross margin down a bit sequentially, how should we expect that to play out throughout 2013?

Andy Wade

Sure. Chris, this is Andy.

We’ve got some programs in place with our operations folks to help offset some of the things I talked about earlier in terms of the device excise tax. And also the pricing pressure that we might expect, which again would be very small, but obviously we have given the guidance that 70% to 72%, we’re working on some programs to help offset those.

So I’d anticipate modest improvement as the year goes along. And then especially, as we ramp and grow, as we get further in outside of ‘13 we would continue to expect to leverage our operating structure.

Chris Luis – ROTH Capital Partner

Okay. Thank you.

Operator

And at this time, I am showing no further questions in queue. I will like to turn the call back over to Mr.

Mike Carrel for any closing remark.

Mike Carrel

All right. Well, everybody thank you very much for joining us today.

Look forward to speaking with you on the road over the coming months. Have a great day.

Operator

Ladies and gentlemen that conclude today’s conference. We thank you for your participation.

You may now disconnect. Have a great day.

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