AtriCure Inc (ATRC) 2015 Q2 法說會逐字稿

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  • Operator

  • Good afternoon, and welcome to AtriCure's second quarter 2015 earnings conference call.

  • My name is Karen, and I'll be your coordinator for the call today.

  • (Operator Instructions).

  • As a reminder, this call is being recorded for replay purposes.

  • I would now like to turn the call over to Lynn Piper from Westwicke Partners for a few introductory comments.

  • Lynn Piper - IR

  • Thank you.

  • 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 emailed to you.

  • Before we begin today, let me remind you that the Company's remarks include forward-looking statements.

  • Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control, including risks and uncertainties described from time to time in AtriCure's SEC filings.

  • AtriCure's results may differ materially from those projected on today's call, and AtriCure undertakes no obligation to publicly update any forward-looking statement.

  • Additionally, we may refer to non-GAAP financial metrics.

  • A reconciliation of these non-GAAP measures with the most directly comparable GAAP measures is included in our press release, which is available on our website.

  • With that, I'd like to turn the call over to Mike Carrel, President and Chief Executive Officer.

  • Mike Carrel - President and CEO

  • Thank you, Lynn.

  • Good afternoon, and thank you for joining us, everyone.

  • We are pleased to report solid second quarter results which reflect our consistent progress in building AtriCure's commercial, clinical and education-focused platform.

  • Based on these results, we are raising our guidance for 2015 to a range of $127 million to $129 million, reflecting approximately 21% to 23% year-over-year growth on a constant currency basis.

  • We are encouraged by the stability we are seeing in the business, day after day and quarter after quarter.

  • The consistency of results demonstrates our maturing business, which we will continue to fortify with long-term investments.

  • We have a lot to look forward to.

  • Turning to the quarter, our second quarter revenue reached $32.6 million, an increase of 23% as reported and 27% constant currency when compared to the second quarter of last year.

  • We demonstrated solid growth across all of our product lines in the US, where sales grew 29% year over year.

  • US open-heart sales were up 26%, MIS was up 15%, and AtriClip sales were up 59% in the quarter.

  • Open Clip was up 56%, while AtriClip Pro grew 67%.

  • On the international front, sales increased 4% as reported and 18% constant currency.

  • As you know, the dollar has strengthened against virtually all major currencies, resulting in a significant foreign exchange impact on our international sales.

  • In the midst of these headwinds, we continue to see strong growth from our direct sales channels, driven by key contributions from Germany and the UK.

  • Sales were softer in distributor channels, particularly the Eastern European area.

  • Turning to our business trends, management of the left atrial appendage continues to be the strongest trend we see amongst physicians, and is the fastest-growing portion of our business.

  • At the Heart Rhythm Society meeting in May, LAA management was again a hot topic, and related sessions were very well-attended.

  • We continue to believe we are just scratching the surface of this multi-billion-dollar market and that the AtriClip device is the best way occlude the LAA.

  • Physician training and education remain important pillars to our strategy.

  • To date, we have trained more than 2,000 physicians and staff at over 500 unique hospitals throughout the United States.

  • We are continuing to see tremendous benefit from our efforts.

  • Physicians who participated in our training courses in the second half of 2014 are now 6 months out, and we can see a market increase in the utilization in their accounts.

  • We are now offering one advanced technical training course per month, and will begin offering master's level training courses later this year.

  • These are all for concomitant procedures.

  • Our first master's course is in Boston later this summer.

  • We will have initiated an on-site, in-person training program for even more in-depth learning and expertise as well.

  • As an example of one such training, during Q2 three physicians traveled to during to Asheville, North Carolina and sat in on five concomitant procedures with our KOL there, who is an expert in concomitant Afib treatment, to get a better understanding of the surgical techniques.

  • We have also established a sole therapy training program in Europe to increase the number of training opportunities internationally.

  • These programs are just getting underway.

  • Moving on to our product initiatives, which are also going well.

  • Our flexible cryo probe released at the end of 2014 continues to contribute to growth.

  • Additionally, the CRYO2 ablation probe is the first cryosurgical device FDA-cleared for cryoanalgesia, or temporary pain relief, by ablation of the peripheral nerves.

  • This indication provides patients and physicians with better options to manage the pain associated with a thoracotomy.

  • We are already seeing increased account access and new customers from the cryoanalgesia indication.

  • As mentioned on our last call, 2015 will be focused on educating and training physicians on using the CRYO2 probe for cryoanalgesia, and we expect an uptick in CRYO2 sales in 2016, resulting from those activities.

  • This is an exciting new market for us, and reflects our commitment to leveraging our platform for new therapies.

  • Our pipeline of new products is also strong, and we are continuing to advance our RF ablation and cryo platforms, expand our Clip franchise, and find new and less-invasive ways to deliver our technology.

  • In line with our goal to introduce at least two new advances to the market every year, we are planning to launch additional cryo enhancements in the second half of 2015, and several new AtriClip products in early 2016.

  • Now for an update on our clinical programs.

  • We are investing a remarkable amount of time and energy into a robust clinical program that includes FDA, international and sponsored trials.

  • This is the year we are meaningfully accelerating our clinical science mission to ensure we gather data that will build a foundation for many years to come.

  • Our Staged Dual Epicardial Endocardial Procedure for treatment of Afib, or DEEP AF trial, is up and running, with 10 sites through the IRB process and 10 patients enrolled to date, with zero complications.

  • The excitement around DEEP was palpable at HRS, as EPs and hospitals are eager to be part of this study.

  • They do not have a good solution to treat the most difficult, sick and complex Afib patients and, like us, believe this therapy will be successful in improving thousands and thousands of patient lives.

  • As mentioned in our last call, we're expecting enrollment to accelerate in the second half of 2015 as more sites complete the IRB approval process.

  • We anticipate 2 years to achieve full enrollment of 220 patients.

  • We are pleased with the momentum and building pipeline of patients, and look forward to providing continued updates to you on future calls.

  • Moving on to our stroke trial, we are still finalizing our protocol to submit to the FDA, and anticipate its completion in the second half of the year.

  • As we've previously discussed, there's a strong interest in this trial, and the right study design is critical to enrollment and, ultimately, trial success.

  • Therefore, our approach is to be thoughtful and deliberate, and as we carefully researching enrollment criteria to ensure the right design, moving into this trial.

  • On our last call we introduced our ATLAS trial, which is a pilot study with the hypothesis that prophylactic exclusion of the left atrial appendage with the AtriClip device will decrease composite events of reoperation, significant bleeding, and stroke/TIAs postoperatively, when compared to a second arm of patients treated with medical management for postoperative Afib.

  • We have finalized the design protocol and expect to begin enrollment near the end of 2015.

  • At full capacity, we expect to enroll approximately 1,200 patients across 10 sites.

  • Simultaneously, we are pursuing a trial in Europe, CEASE-AF, to compare the staged DEEP hybrid procedure with multiple catheter ablations.

  • We have finalized the study protocol and anticipate enrollment of the first patient in the fourth quarter.

  • We expect the study to enroll approximately 210 patients across 12 centers, all leading institutions throughout Europe.

  • On the sales and marketing front, we continue to strengthen our organization.

  • Ralf Link has come on board as our VP of Europe Sales, and we are seeing great contributions from his leadership efforts already.

  • Ralf is a seasoned European leader and has over 25 years of experience, working with Guidant, Endologix and Volcano.

  • In summary, we are continuing to make strong progress in 2015 which reflects our consistent and ongoing investment in development efforts.

  • We remain committed to our investments in education, training, innovation and clinical science, which we will -- which we believe will fuel further positive momentum.

  • I'll now turn the call over to Andy Wade, our Chief Financial Officer.

  • Andy Wade - CFO

  • Thank you, Mike.

  • For the second quarter of 2015, revenue increased 22.9% on a GAAP basis to $32.6 million.

  • On a constant currency basis, worldwide revenue increased 26.5%.

  • Revenue from product sales in the US was $25.7 million, an increase of 29.3% from the second quarter of 2014.

  • Revenue from open-chest ablation-related product sales in the US increased by approximately $2.8 million to $13.6 million, representing growth of 25.7%, driven by our education and training efforts as we build this still underpenetrated market for concomitant surgical ablation.

  • US sales of products used in minimally-invasive procedures increased approximately $700,000 to $5.1 million, up 15.1%, and driven by all MIS products.

  • As with the first quarter, the Fusion product line continued to grow faster than exe.

  • As of now, all Fusion sales are being captured in our MIS category, although some Fusion revenues are coming from aortic valve and CABG procedures.

  • Overall, while we are pleased with the solid growth of the MIS business in Q1 and Q2, we do still continue to believe that this business will only see modest growth during the rest of 2015.

  • Continued development of clinical data in support of MIS ablation for the treatment of Afib through trials such as our DEEP IDE study, are critical to growing this market.

  • US sales of the AtriClip system during the second quarter of 2015 were $6.3 million as compared to $3.9 million for the second quarter of 2014, an increase of 59.1%.

  • We continue to be encouraged by the strong performance of this part of our business, with very strong growth in both the open and minimally-invasive AtriClip products.

  • International revenue grew 3.5% on a GAAP basis and 17.9% on a constant currency basis, as compared to the second quarter of 2014, to $6.8 million.

  • Strengths included the direct markets in the EU, as well as certain distributor markets.

  • Valve tool sales were roughly $900,000 worldwide -- approximately $800,000 in the US and $100,000 in international markets.

  • Gross margin for the second quarter of 2015 was 70.9% as compared with 70.8% for the second quarter of 2014.

  • The primary drivers of improvement were the increased mix of US sales and the elimination of the Estech transition-related expenses recorded in 2014.

  • Offsetting these improvements were heavier loaner depreciation and a slight uptick in scrap and obsolescence charges related to non-core and Estech products.

  • Operating expenses increased 29.1%, or approximately $6.3 million, from $21.6 million for the second quarter of 2014 to $27.9 million for the second quarter of 2015.

  • Note that the prior-year SG&A expense included a $2.7-million income item due to the adjustment of the Estech acquisition-related earnout liability.

  • Without this, operating expenses are up $3.6 million, or 15%.

  • Research and development expenses, which include clinical and regulatory activities, were $5.9 million for the second quarter of 2015, or 18% of sales, an increase of $1.3 million over the second quarter of 2014.

  • The increase was driven by both clinical trial and product development efforts.

  • SG&A increased approximately $5 million from the second quarter of 2014 to a total of $22.1 million, or 68% of sales.

  • Without the earnout adjustment in the prior year, SG&A expenses are up $2.3 million, or 11.9%.

  • The increase is driven primarily by selling expenses, including heavier performance-based compensation based on strong US performance, marketing expenses and training activities.

  • The increase was partially offset by approximately $600,000 in acquisition-related transitional expenses that were recorded in the second quarter of 2014.

  • Our operating loss for the quarter was $4.8 million, compared to $2.9 million for the second quarter of 2014.

  • Our adjusted EBITDA loss was approximately $1 million this quarter, compared to a $2.5 million adjusted EBITDA loss for the second quarter of 2014.

  • Our net loss per share was $0.18 for the second quarter of 2015, compared to $0.10 for the second quarter of 2014.

  • We ended the quarter with approximately $60 million in cash, cash equivalents and investments.

  • Lastly, we are positively adjusting our guidance for 2015.

  • We anticipate constant currency worldwide growth of approximately 21% to 23%, up from our previous guidance of 17% to 19% constant currency growth.

  • At current exchange rates, this represents approximately 18% to 20% year-over-year worldwide growth on a GAAP basis, or a range of $127 million to $129 million.

  • We continue to anticipate gross margin to be approximately 71% to 72% for the year, based on current trends and investments to support our growth.

  • The bottom end represents a slight increase from the 2014 reported gross margin.

  • Items with a positive effect on gross margin include volume leverage, no additional nonrecurring costs from the Estech acquisition, and programs to increase efficiency.

  • Headwinds on gross margin include continued heavy loan or capital placement, placing a new building into service in the fourth quarter of this year, and other manufacturing costs.

  • We are still targeting long-term gross margins of 75%, and believe this is achievable within the next 5 years due to increased volumes and efficiency.

  • We expect R&D to be 19% to 21% of sales, driven by spending in clinical trials and product development.

  • We expect SG&A to be roughly 69% to 70% of sales in 2015, driven by continued increases in spending related to selling, training and education, and international expansion.

  • Adjusting for the one-time Estech transaction-related items in 2014, this represents a slight leveraging of SG&A expenses.

  • We expect adjusted EBITDA for 2015 to be a loss of approximately $7 million to $8 million.

  • From a cadence perspective, we expect the third quarter loss to be higher than the current quarter, with improvement into the fourth quarter.

  • The improvement from 2014 is driven primarily by the completion of the Estech transition in 2014, as all nonrecurring costs were complete by the end of the year.

  • We continue to feel that the investments in clinical science and product development are driving the bulk of the EBITDA loss, but are warranted given the exciting long-term growth plan of the Company.

  • At this point, I would like to turn the call back to Mike for closing comments.

  • Mike Carrel - President and CEO

  • Thank you, Andy.

  • In sum, we are encouraged by results and looking forward to continued momentum in the second half of the year.

  • Our focus remains clear -- to continue to invest in our clinical and commercial efforts while improving patient lives with our innovative products.

  • We look forward to updating you on our progress during future calls, and we will now open it for questions.

  • Operator

  • (Operator Instructions).

  • Tom Gunderson, Piper Jaffray.

  • Tom Gunderson - Analyst

  • So, I want to ask two questions on the clinical side, Mike, on AF.

  • I think you said 10 sites have gotten IRB approval and 10 patients enrolled; acceleration in the second half.

  • I didn't -- I missed what you said after that.

  • Can you give me a little more color on the acceleration you see in the second half, and if there's anything really getting in the way, other than things take time, on the IRBs?

  • Mike Carrel - President and CEO

  • Yes.

  • The acceleration is more in the patient enrollment.

  • The first 10 sites were sites that were critical to kind of come on board.

  • They were the ones that have been doing this procedure for a long period of time.

  • And so, they were ones that we kind of got through.

  • But a lot of them didn't come online until the May/June timeframe.

  • And so, the patient queue really is just starting up now, in July and August.

  • And so, we anticipate that enrollment will kind of come together a lot more briskly in the second half of the year, in particular in the fourth quarter.

  • We're targeting to kind of close out the year around that 30 or so, in terms of patients that be enrolled, and 15 or -- sites up and running, and actually enrolling by the end of the year as well.

  • So, really, it's all gearing up towards a really strong 2016 from an enrollment standpoint, and kind of getting these sites up and running and getting patients into their pipeline.

  • Tom Gunderson - Analyst

  • And then, from a timing standpoint, does that -- enrollment could end, what, in 2016, early 2017?

  • Mike Carrel - President and CEO

  • No, we're still anticipating July 2017.

  • So, we still feel like that's the right date to put.

  • If we come in ahead of plan, that would be great.

  • But we're not going to rush it to come in ahead of plan.

  • We don't think that 3- or 6-month difference will change anything for us overall.

  • So, we're focused on making sure that we're getting them up and running, the sites are really well-equipped to do the procedure, and so we feel good about that, and July 2017's the date.

  • Tom Gunderson - Analyst

  • And then the second question on the stroke trial.

  • The protocol that you're putting together, I'm assuming, takes quite a bit of brainpower, and you're talking to a lot of different participants as far as how this protocol will look, and get the job done in the end.

  • Do you feel like you are crossing t?s and dotting i?s at this point, from an engineering standpoint, if we use that as an analogy?

  • Is the design frozen, or is there still some discussion going on as to how the stroke trial should be carried out?

  • Mike Carrel - President and CEO

  • It's not as much on the design, per se, but much more on the patient population and, kind of, the focus areas of it, in terms of going after the high-risk patients, and how does one define exactly what the high-risk patients are, in terms of what their CHADS-VASc scores are, and what their HAS-BLED scores are?

  • And so, we're in the process of working with neurologist -- our stroke neurologist -- EPs cardiologists, and surgeons; but really the first three in particular, just to make sure that we've got that right.

  • And we're talking to people both internationally and domestically, on their experience about the appendage from that standpoint.

  • So, we just want to make sure that we're going to get the right population; we're going to be able to enroll in it.

  • And so, that's really, kind of, the key piece to it now.

  • But the basic design of it is pretty much done.

  • It's really -- kind of, really, that criteria for patients, mostly, that we're working on now.

  • Tom Gunderson - Analyst

  • Got it.

  • That's it for me.

  • Thanks, Mike.

  • Operator

  • Jason Mills, Canaccord Genuity.

  • Jason Mills - Analyst

  • Congrats on another great quarter.

  • So, let -- start with -- I mean, your performance in the first half of the year, it goes without saying, was quite good, and you've raised guidance two straight quarters.

  • Mike, I'm just wondering -- as you've gone through, now, the training program, and it's evolved over the last couple of years, what does it tell you about the sustainability of the growth rates going forward?

  • Obviously you've raised your guidance, but the second-half guidance does imply a little lower growth rate than the first half -- perhaps that's difficult comp -- and still very solid growth.

  • But I'm just wondering, as we look forward, what you see out of the pipeline in terms of the bandwidth to continue to grow the open-heart market like you've been able to grow it.

  • Mike Carrel - President and CEO

  • I'd say -- I'll answer that in a couple of ways.

  • I think you're right in terms of the assessment of the back half of the year, and we feel great about the business.

  • Day in and day out, we see numbers coming in, and we feel very confident about, kind of, where we are; where we're going.

  • Obviously, that's why we've raised the guidance.

  • The growth rate, like you said, does fall a little bit; but we're trying to be cautious just to make sure -- we've got tougher comps, as you mentioned, in the back half the year.

  • Last year, if you recall, we accelerated growth [at] the beginning to the back half of the year.

  • And so, we just want to make sure that we're comfortable with kind of making sure we can continue down that path.

  • But we do feel good about the business long-term, and we feel like that's got legs into 2016.

  • We feel like 2016's going to be a strong year for us.

  • Obviously, we're not equipped to give guidance this early on in the process, but we feel really good, kind of, about looking through -- this is really sticky revenue; we continue to grow on the open side; cryo continues to be a really strong leg for us in the business; and the Clip has really good growth for us.

  • So, across those, it's the same patterns that we've seen, and we continue to see some good, strong growth, obviously at a higher growth rate than we had originally anticipated at the beginning of the year, and it's consistent.

  • Hopefully that --

  • Jason Mills - Analyst

  • That's helpful.

  • Yes, it was.

  • And you segued nicely into the second question about the Clip.

  • You're doing, now, a new run rate of $20 million -- in the $25 million range for the year.

  • And you mention that you're launching a couple of new Clip products in the -- I think you said the beginning of 2016.

  • Could you talk about the LAA market?

  • You discussed it at length at your Analyst Meeting and talked about the underpenetration of that market, and the runway to go.

  • But maybe give us an update along those lines, and also maybe some flavor on the new products that you expect to launch.

  • Thanks.

  • Mike Carrel - President and CEO

  • Sure.

  • A couple of things on the market.

  • I mean, when you think about the concomitant market, if you just take open-heart surgeries, there are 100,000 patients just in the US, and last year in 2014 we sold 12,000 Clips.

  • So, if you take a very conservative number and you can -- we're only 12% penetrated in the market that, the chest is already open and you can put the clip on right then and there, and so, we're seeing a lot of traction in that market.

  • We see that that's going to continue to grow in the US.

  • And quite frankly, actually, OUS is starting to actually grow.

  • It's off a much smaller base, but the growth rate OUS is actually higher; but again, off a much smaller base.

  • We're starting to see of that bleeding over on the international front -- some of the progress that we've made in the US and some of the training that we've done here, relative to that.

  • So, we feel like it's extremely underpenetrated.

  • We've got a long growth cycle here for many years to come, and feel really good about it.

  • Obviously the growth rate can't sustain at that level, but the overall growth will continue at a very strong pace going forward.

  • When you start to look at the products we've got for next year, they're much more focused on the Pro.

  • So, it's Pro 2 and Pro 3 that we'll be rolling out next year.

  • And we're excited about bringing out two brand-new products in that area.

  • They make it easier for the surgeon to use the product.

  • It's got a better handle.

  • It's got an easier way to kind of manipulate it.

  • It's got more articulation; you can hold it into place a lot more cleanly, and many other new innovations that are going to come out, that are based on feedback we've gotten from surgeons and even EPs over the course of the last couple of years.

  • So, we've spent a lot of time with our customers; a lot of with people that aren't customers, to tell us why they don't use it; and we've got a bunch of really new, neat improvements coming out next year, that will hopefully continue to help us sustain some growth there.

  • Jason Mills - Analyst

  • Thank you.

  • Operator

  • Rick Wise, Stifel.

  • Drew Ranieri - Analyst

  • This is Drew Ranieri, in for Rick.

  • Just two questions, the first kind of on competition in the market.

  • You've commented before about your view that the Watchman is a positive for increasing left atrial appendage awareness broadly.

  • I mean, how have you been seeing that in reality, and is there a way to quantify it?

  • And jointly with TigerPaw's recall announcement earlier this year, and now Lariat's FDA safety communication, do you think this does anything to tarnish epicardial closure devices in general, or is this really just another positive for AtriClip?

  • Mike Carrel - President and CEO

  • I'll start with the Watchman one.

  • On the Watchman, it's tough to quantify anything.

  • It's just that, by them being in the market, and being such a big player, there are more societies that come up; there's more talk about the left atrial appendage; and there's more belief in managing the left atrial appendage.

  • And so, it benefits us that way, more than anything else, and I think that really kind of breeds confidence on the concomitant market, that people understand, oh, wait, I should manage the appendage.

  • I've got the chest open.

  • It's a very reasonable price for that marketplace, because it's not a lot of cost to add, and for that cost you're basically taking something so they don't have to [again endure] reoperation at a later point in time.

  • And so, I think it's helping us from that standpoint.

  • It's -- but it's soft.

  • It's not like I can say, oh, this is exactly what the direct correlation is.

  • It's just, there's just more activity and more discussion about it.

  • When you go to different conferences, almost all of it's driven and around the Watchman and those percutaneous approaches, but they also say, hey, wait; when you've got the chest open, you should really be taking care of it as well, and using something like the Clip from that standpoint.

  • So, we get a benefit there again.

  • It's soft, but again, I think that it's a positive.

  • As it relates to the other two products that you talked about, from our standpoint it's not a positive or negative for the epicardial piece.

  • We know our product works.

  • We've implanted about 54,000 of them to date.

  • We've got -- and it's all public knowledge.

  • We've got very few MDRs across that -- less than 0.05%, in terms of any issues with our product.

  • So, we feel really comfortable with the safety profile of our product; how well it's being used.

  • And so, we're feeling really good about it from that standpoint.

  • But no comment on the specific companies.

  • Drew Ranieri - Analyst

  • Great.

  • And then just the next question on the sales force.

  • In the past you've talked about adding 5 or 6 people to sales and clinical support over the next several years.

  • I mean, are there any conditions that you have to see to really accelerate sales force add-on?

  • And also, can you go direct in the Eastern European countries to kind of offset the distributor weakness?

  • Mike Carrel - President and CEO

  • Repeat the first question again.

  • I'm sorry.

  • I don't know that I grabbed it completely.

  • Drew Ranieri - Analyst

  • In the past you've just talked about adding 5 or 6 people to the sales side and clinical support side over the next several years.

  • So, are there any conditions that you would have to see to really just accelerate sales force add-ons?

  • Mike Carrel - President and CEO

  • I still think those numbers are still good numbers, on the 5 or 6 per.

  • We might add more management.

  • Obviously, we're growing at a faster pace, so if we continue to grow at that kind of pace, we might add -- maybe [it's] adding one or two additional people on top of that.

  • But that's within the range.

  • I mean, that -- it's not a huge impact.

  • We're not talking about doubling that number.

  • I don't anticipate that in the near term.

  • I think that that 5 or 6 is still a good solid number to kind of look for over the course of the next several years.

  • In terms of the international base, no, we're not planning on going direct in any of those markets.

  • We just get lot of softness in the countries that you would imagine.

  • Russia's just -- given all the turmoil over there, it's hit or miss in terms of a particular quarter, in terms of softness there.

  • It's a great market, I think, long-term; you just have to deal with the issues relative to an economic and political standpoint, and what the purchasing is there.

  • But we're not going to go direct in any of those countries.

  • Drew Ranieri - Analyst

  • Great.

  • Thank you.

  • Operator

  • Mike Matson, Needham & Company.

  • Brad Mas - Analyst

  • This is actually Brad, in for Mike.

  • Just -- first off, just wondering if you can, Mike, provide any details on the -- Dr. Cox's Fellowship Program.

  • I mean, has that started?

  • And then, just any other details you can provide.

  • Mike Carrel - President and CEO

  • Sure.

  • We did roll out the program, and it looks like we've got one or two people that are actually going to be entering into the program this year.

  • And we're getting a lot of activity, looking forward to next year as well, and a lot of positive responses that we're potentially going to actually bring it out and bring internationally.

  • Because we're getting -- from people over in Europe, they want to actually do some of these, and we may open that up as well, from -- to international people.

  • So, it's going well from that standpoint.

  • We're starting to get some good traction, and good press with it, and the AATS, I think, is extremely happy with the overall progress.

  • Brad Mas - Analyst

  • And that's a 3-month course, right?

  • Mike Carrel - President and CEO

  • That's correct, yes.

  • Brad Mas - Analyst

  • And then, just my last question would be, I think you said there were about 140 last quarter.

  • I'm just wondering how many more physicians you've trained with the advanced -- the phase two advanced course that you've talked about.

  • I know you're doing one a month in the US, and a little less outside the US.

  • How many people are in those classes?

  • Mike Carrel - President and CEO

  • There are anywhere between 10 and 15 people per course, so you can imagine that we're probably getting between 30 and 45 additional people to go through the advance trainings every quarter or so.

  • Brad Mas - Analyst

  • Okay.

  • And then, just last one for me, I must missed the split between the growth of the AtriClip.

  • Can you throw that out there again, Andy?

  • Andy Wade - CFO

  • Yes.

  • 56% open and 67% minimally-invasive.

  • Brad Mas - Analyst

  • Great.

  • Thank you very much, guys.

  • Operator

  • Danielle Antalffy, Leerink Partners.

  • Danielle Antalffy - Analyst

  • Thanks so much for taking my question.

  • Mike, first question for you -- I was wondering if you could give any color on the split of your concomitant surgical ablation business between mitral, aortic and CABG.

  • Because obviously, mitral is more penetrated, but aortic and CABG represent significant growth opportunities.

  • So, just trying to get a sense of how much runway, still, we have in each of those categories?

  • Mike Carrel - President and CEO

  • Well, I think we still have a lot of runway in all three of those categories.

  • Mitral is about 60$ or so penetrated.

  • So, you've got about 40% still left to go; maybe even up to 50%, in terms of overall penetration.

  • And then the other ones are less than 10%.

  • But we're seeing a lot of traction on the AVR and CABG market.

  • And as Andy mentioned in his script, people are beginning to use the Fusion to actually work with the clamps in that particular environment, because they like the transmural lines that they're getting with it, as opposed to using the pens that we've had from before.

  • So, we're starting to see some traction on that front as well.

  • And that seems to be something that just kind of gathers organically on its own.

  • Danielle Antalffy - Analyst

  • And have you ever given a number of accounts or, sort of, a percentage of accounts that -- or, I'm sorry, procedures in which more than one device is used?

  • So, just trying to get a sense of, sort of, the halo effect between -- I talk to a lot of physicians that do the concomitant ablation and just throw the Clip in as well.

  • Do you have any sense of how many of the products that are done are using more than one device, and how that number has been growing?

  • Mike Carrel - President and CEO

  • Almost every one of ours.

  • We don't know on a -- we don't know specifically on a procedure level, because we don't track -- we can't track it by procedure.

  • But what we do know is, the accounts buy multiple products, and almost every procedure has multiple products in it.

  • So, I mean, usually at a minimum what they'll typically have is a clamp and a Clip; and then sometimes they'll do clamp, Clip and cryo.

  • And then I'd say the one that probably gets the least -- and what we call, go for a home run on it, is when you get the pen, and you get confirmation.

  • And many of you have heard the 4 Cs -- the clamp, the cryo, the Clip, and then confirmation.

  • That's ideally what somebody's going to do, to get the best results.

  • And so, we're kind of out there with that, as kind of the baseline to do the whole Cox-Maze IV.

  • Danielle Antalffy - Analyst

  • Okay.

  • Got it.

  • And then, the last question for you -- as we think about lots of progress on the clinical trial front; the post-approval study -- we should see some early data there.

  • I think you said next year.

  • Is that right?

  • Mike Carrel - President and CEO

  • Yes.

  • Exactly.

  • Danielle Antalffy - Analyst

  • Yes.

  • So, how do we think about that -- and I'm not asking for you to provide guidance, but just sort of getting a sense of, is that something that could drive a step function increase, is that just sort of incremental -- in procedure volumes?

  • Or, is that sort of just incremental?

  • How do we think about that?

  • Mike Carrel - President and CEO

  • I think it's just incremental.

  • I know some of our investors and others think that it might have a -- some sort of step function increase to it.

  • There's a lot of activity going on right now just in general around Afib, and there's activity going on out there, and papers that are being written.

  • I think it's going to help, but I don't necessarily know that it's going to be a step function.

  • I think it's a continuing of news that continues to come out about, if you treat people, they do better than if you don't.

  • Danielle Antalffy - Analyst

  • Yes.

  • Okay.

  • That's fair.

  • All right.

  • Thanks, guys.

  • Operator

  • Thank you.

  • And that concludes our question-and-answer session for today.

  • I would like to turn the conference back over to Mike Carrel for any closing comments.

  • Mike Carrel - President and CEO

  • Well, great.

  • Well, thank you, everyone, for joining today and participating in the call, and your interest in AtriCure.

  • Have a wonderful evening.

  • Operator

  • Thank you.

  • Ladies and gentlemen, thank you for your participation in today's conference.

  • This does conclude the program, and you may now disconnect.

  • Everyone, have a good day.