Good afternoon. And welcome to AtriCure's Third Quarter 2024 Earnings Conference Call. This call is being recorded for replay purposes. And at this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session following prepared remarks from AtriCure's management. I would now like to turn the call over to Marissa Bych, from the Gilmartin Group for a few introductory comments.

Great. Thank you. By now you should have received a copy of the earnings press release. If you have not received a copy, please call 513-644-4484 to have one e-mailed 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. These statements include, but are not limited to, financial expectations and guidance, expectations regarding the potential market opportunity for AtriCure's franchises and growth initiatives, future product approvals, clearances, competition, reimbursement and clinical trial outcomes. AtriCure's results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statements. Additionally, we refer to non-GAAP financial measures, specifically constant currency revenue, adjusted EBITDA and adjusted loss per share. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release which is available on our website. And with that, I would like to turn the call over to Mike Carrel, President and CEO.

Great. Good afternoon and thank you for joining us, everyone. I am happy to share that our third quarter results which reflect another strong quarter for AtriCure. We achieved total revenue of $116 million or approximately 18% growth, showing broad-based demand across our portfolio of innovative products for patients with atrial fibrillation and postoperative pain. In addition to our top line performance, we continue to make progress to expand profitability, producing nearly $8 million of positive adjusted EBITDA for the quarter. We also generated over $16 million in positive cash flow this quarter, marking our second consecutive quarter of positive cash flow. As a result of the strength in our third quarter results, we are raising our full year 2024 revenue guidance, and now expect a range of $459 million to $462 million, reflecting growth of approximately 15% to 16% over a full year 2023. We're also reaffirming our plans to deliver a full year adjusted EBITDA of $26 million to $29 million. Turning to updates on our business and highlights in the quarter. Starting with our pain management franchise, which grew 36% worldwide, marking another quarter of acceleration in sales. Our performance was led by growth in our international markets and bolstered by the U.S. launch of our cryoSPHERE+ probe. We've seen outstanding adoption of this device which contributed nearly half of our pain management sales in the quarter, and are hearing consistent positive feedback from our physician partners on the 25% reduction in freeze time. We are also excited about the recent launch of our cryoSPHERE MAX probe, which builds upon the success of cryoSPHERE+. Our Max probe features a larger 10 millimeter ball-tip designed to optimize procedure efficiency by reducing freeze times even further than the cryoSPHERE+. Additionally, we are seeing a growing body of evidence supporting…

Thank you, Mike. Our third quarter 2024 worldwide revenue of $115.9 million increased to 17.9% on a reported basis and 17.8% on a constant currency basis when compared to the third quarter of 2023 demonstrating ongoing strong performance in key markets around the world, and the impact of our diverse range of products. On a sequential basis, the 0.3% decline in worldwide revenue from the second quarter to the third quarter of 2024 reflects normal seasonal variation and underlying procedures. Third quarter 2024 the U.S. revenue was $95.5 million, a 16.8% increase from the third quarter of 2023. Open ablation product sales in the U.S. were $30.6 million, up 18.4% over 2023 from robust Encompass clamp sales across both, existing and new accounts. U.S. sales of appendage management products were $37.4 million, up 15.6% over the third quarter of 2023. Within U.S. appendage management revenue, our open appendage management products, driven by our AtriClip FLEX fee device realized a third sequential quarter of acceleration reaching 20% growth over third quarter of 2023. U.S. minimally invasive ablation sales were $11.1 million, up 2.1% from 2023. As Mike mentioned in his remarks, although we are activating new accounts and seeing positive trends with respect to the accounts ordering, we continue to experience pressure on the pace of HybridAir [ph] AF therapy uptake. And finally, pain management product sales were $16.3 million, up 29.6% over the third quarter of 2023 reflecting accelerated growth driven by the recent launch of our cryoSPHERE+ probe. International markets once again delivered excellent results with revenue of $20.5 million, up 23.3% on a reported basis, and 22.4% on a constant currency basis as compared to the third quarter of 2023. European sales contributed $12.2 million in the quarter, representing 33% growth, while sales in Asia Pacific and other…

Thank you, Angie. As we enter the second half of 2024, we saw strong growth on the top and bottom line; continued innovation with AtriClip Flex Mini and cryoSPHERE MAX launches, and expansion of the geographic reach of our products with our AtriClip now approved in China, our Encompass launch in the EU, and our AtriClip stroke label expansion in Europe as well. Our strong revenue growth in third quarter is a testament to the resilience and diversification as the portfolio of therapies we have built. With the strength of our team worldwide, the quality of our products and the clinical data behind our therapies, there is little doubt in my mind that AtriCure is well positioned to drive compelling growth and expand profitability for years to come. And with that, we'll turn it over to the operator.

[Operator Instructions] And our first question comes from Robbie Marcus with JP Morgan. Your line is open.

Hi, this is Lilia on for Robbie. Thanks for taking the question. Just wanted to get your thoughts on the trends that you're seeing from PFA. Is this the new normal to expect, with pressure to both, MIS ablation and the MIS clip business? Or do you think momentum in those areas can improve as [indiscernible] becomes more commonplace in the market? And what sort of assumptions regarding those dynamics are you taking into guidance?

Yes. As we looked at the rest of this year, I’d say that’s kind of more than new normal for the rest of this year. But as you look out over this into the future; because there can be a lot -- there's a lot of new products coming into market, etcetera, right now, causing the distraction to the size, they get up, up and running using those new products, etcetera. But what we're also seeing is an incredible amount of new patients coming into the funnel, so that the top of the funnel of patients is very large. And with our experience in Europe, what we can see is that they eventually have non-responders, a great deal of non-responders; and so what we do anticipate is that that funnel is going to lead you a lot more patients needing to be treated. Once they don't respond to PFA or that second or third ablation, they're going to kind of hold on to that funnel. Now, we do believe that in 2025 we'll start to see some of those; we've seen some of it already a little bit from patients that were involved in some of the original PFA trials here in the U.S. We do anticipate that that'll probably begin to start up in 2025, not ready to kind of give any kind of month or quarter that you're going to start to see any kind of spike necessarily, but we do anticipate that with that huge volume in the top of the funnel, you're going to see patients come out that need another ablation [indiscernible] to really help them out for those long-term and difficult to treat patients.

And Lily [ph] relative to the guidance, I would say, as you know, Q4 last year was a very strong quarter for our U.S. hybrid, and also our MIS AtriClip business. So that was one of the considerations as we thought through kind of the rest of the year guide.

Got it, that's helpful. And then as a follow-up, I was hoping you could give a bit more color on the PFA partnership. Is there anything you can share on who the partner is that you're working with? And what sort of timeline should we expect for a launch here? Thanks so much.

Yes, appreciate that question. And of course, anticipated. You know, we're really excited about what we've done there. The reason we were able to announce now is, obviously we signed the agreement and we'll be obviously writing the check that Angie talked about. But in addition to that, we’ve made a tremendous amount of progress over the course of the last nine months on development, and we feel like we're in a really good development place for that as well. So, there's a lot of confidence on our side that this is going to be a real technology force that's going to be embedded into our cardiac surgery devices. Not ready to give timelines on first in human or when we might go into a clinical trial with it, or who the partner is yet, but in due time that will definitely come out.

Thank you. Our next question comes from William [ph] with Canaccord Genuity.

Just first on Encompass clamp; I just wanted to clarify, did you say that the U.S. business, the clamp grew 50% year-over-year. Is that correct?

Yes, it was about 50% growth of the Encompass clamp in the third quarter.

Okay. And then, as we think about Encompass O-U.S. [ph], you know, you just got that CE mark, given the growth O-U.S. [ph] in the third quarter, I would assume that you really didn't see a benefit from that, if anything, you might have seen some de-stocking or what have you. How should we think about that impact if you go into the fourth quarter, in forward, now that you have that CE mark, given what we’ve seen in the U.S. from that product?

Yes, first I'll start. And -- I mean, the European team is really excited about the Encompass clamp. I was over at the major cardiac surgery Society meeting over there, called EAX [ph], just in the early part of October. Our booth was packed, we had a simulation lad, and we had over 250 people and physicians visit our booth, go through simulation lab. Leveraging that, we actually launched the product officially while we were there, and it was -- and then we also had a standing room only audience to kind of talk about what that product meant for the market as well. So the team there is really excited, they’ve been well trained and positioned on it in the market. We won't see much of an impact in the fourth quarter per se, but we do see that they will obviously have an impact on next year for sure as we enter the market. It won't go as fast as the U.S. just because individual countries have different reimbursement plays, etcetera, but they're ready to kind of get through that, and we do anticipate some impact in 2025.

I just would add, relative to the international numbers and open ablation more impacted by what kind of our market is outside of Europe, or our European growth in open ablation was very strong; this was more kind of the distributor ordering in the third quarter that impacted open growth.

Okay. And then just on this PFA partnership, I know you'll give us more details in the future, but I'm kind of curious, you know, I think you've had plans of -- kind of getting to that cash flow consistently positive. Now you're talking about an investment in this PFA for the cardiac devices; does that change the kind of your near-term, intermediate-term outlook is? Maybe you're increasing the R&D spend or is this just shifting priorities within an R&D? Thanks for taking my questions.

I think this was part of our overall R&D plan, and has been for a while. No change in terms of outlook relative to kind of overall spend or cash burn; obviously, we'll take a charge here in the fourth quarter for the upfront cost, but even with that charge expected to be an overall modest earn for the full year 2024. So no change relative to the trajectory there and it is something that we've been working towards, like Mike said, for a while now, and it’s part of our longer term plan.

I think it’s consistent with what Angie has, and we've stated before that when we look at -- we're not giving guidance for 2025 but we've always talked about the fact that we're going to continue to improve our bottom-line from year-to-year. And so with that it has not changed at all, and our thoughts on that haven't changed in any way.

Thank you. Our next question comes from Matthew O'Brien with Piper Sandler.

Hey, this is Phil [ph] on for Matt. Thanks for taking our questions. I guess, just -- another -- a third great quarter of the U.S. open business. Is it safe to say that a bigger competitor coming into this market is perhaps aiding in general market growth. Any thoughts on what that underlying market grew in relation to your 20% domestic growth here in the quarter?

Yes. I mean, as we talked about earlier, it's a great question, Phil [ph]. When we looked at the market and competition coming in; we always said competition is a good thing because it does create awareness, exactly as you've described. And I think we're definitely seeing that greater awareness get created in the market by having somebody else that's out there talking about the benefits of treating the appendage. And so I'd say the answer -- the simple answer is, absolutely. I can't give a specific underlying growth but I know that the competition is getting some share. Obviously, they're getting some sales that are out there but we still feel like our product is -- our original product, the FlexV [ph] is an exceptional product, and was the best product on the market before the Flex Mini. And the Flex Mini that we talked about on this call has been receiving great reviews; it is a much smaller profile product on the market. I've been out on the road talking to a lot of customers, getting feedback, and just looking at them as they kind of use it for the first time, and it's been just incredible feedback. So that product is going to make a big difference, not just for the end of this year, but also for many years to come.

Thanks, that's helpful. And, just on the -- my second question is, we've been hearing some recent chatter on the Heal IFT [ph] study, you haven't talked about it in a little bit of time. Any renewed interest there or any updates would be helpful. Thank you.

I mean, it is an important study relative to a patient population, for those that don't recall, it's for patients that have inappropriate sinus tachycardia [ph]. It's important, not necessarily for our long-term growth but for the hybrid aspect of our business. We do believe it's really where a surgeon is working with an electro-physiologist [ph] to solve this very difficult patient that, quite frankly, has zero solution out there in the market right now. We've had solid enrollment to date, but we've got to train all these sites as we get them up and running. So there hasn't been a lot of update per se, until we get to some sort of enrolment that we can actually look at the data which we anticipate sometime in 2025 but we've got to get more reporting on at that point in time.

And our next question comes from Marie Tibble [ph] with BTIG.

Thanks for taking the questions this evening, and congrats on a nice quarter. Wanted to see if I could kind of understand rundown of product catalysts, other market catalysts that we might see throughout 2025; definitely not looking for guidance but just trying to understand tailwinds, headwinds, things that might be anniversarying as you think about the products launching here now, and products that you've enjoyed throughout 2024. Just how to think about those catalysts in 2025?

Great question, Marie [ph]. I'd say, if we start at the top with our open franchise, the expansion of the Encompass clamp in Europe; you'll see obviously a full year’s worth of activity over there. With that being said, we still think that this is a catalyst for the U.S. business as we continue to reach additional accounts; we've made great progress on that front, a little under 700 accounts at this point in time. So, there is still room for us to continue to grow in the U.S. When we think about our pain management franchise, you'll have a full year of the cryoSPHERE MAX, as well as the cryoSPHERE+ probe; both were offering reduced freeze times which we think are accelerating our growth. We've obviously seen that this past quarter in the U.S., and we'll continue our efforts to expand pain management throughout our international markets. We've seen some nice activity in Europe, in particular, on that front. Within our hybrid franchise, I'd say this is one where we're likely to see pressure, no catalyst per se, at this point in time. And I'd say with an appendage management, the big thing will be our Flex Mini clip, full year of activity within the U.S., as well as the expansion of AtriClip into China and the enhanced labeling within Europe. So I think that the probably the biggest headwind for growth for us, I think we just run lot of large numbers, you know, we can take it to make great progress here, and the growth that we're expecting off of a pretty nice runway over the past couple years.

Really helpful rundown, Angie. Appreciate that. My follow-up on the PFA partnership; at the risk of sounding a little naive, is this for the MIS product? Is it also for the open product? Is the vision eventually that PFA replaces RF ablation within your franchises? And what sort of change -- I know you've known and followed the PFA space very, very closely for a few years; what sort of precipitated this decision? Thanks so much.

Yes. We've been looking at PFA for over 5 years in terms of getting it into our cardiac surgery products. So there really isn't a change. It's just we finally got realization that now we've actually got product, we've actually done testing on it. We've got -- we're at the point that we could actually feel comfortable coming out and giving you some guidance that we're very close to being able to give some very specific milestones and deadlines here to the market. And so we want to kind of preliminarily kind of say that. But we've been working on it for a long time, and there really isn't any changes as Angie talked about earlier. In terms of our focus and our strategy, it's really all of our epicardial ablation products. We do anticipate bringing it to market through those. We'll give more details at a later date, but the plan is to bring that in. It's not planning on replacing our RF and cryo. RF and cryo are incredibly durable. They're incredibly safe, and they work incredibly well in the market today. They're great products. However, we're an Afib ablation company, and we feel that we need to have all ablation technologies to be able to offer to people and then give physicians that choice as to which they may or may not like better based on whatever their preferences are and what types of tools they might want to use. And so yes, it will be embedded into some of our existing technology in terms of the disposables that we have today. But our overall vision is to be able to provide a full solution so that we can give our customers, our physicians a choice as to how they want to treat their patients best.

Yes. And maybe to put a finer point on that, Marie, we would expect, as Mike said in his prepared comments, first step would be an open cardiac clamp, then followed by some more work in the minimally invasive space.

[Operator Instructions] Our next question comes from Mike Matson with Needham.

Congrats on the strong quarter. Maybe a question for pain management. I think you both had talked about cryoSPHERE MAX really being more of a product to break into the sternotomy market as opposed to plus [ph] or the original cryoSPHERE. So what -- I guess, what are your expectations for the sternotomy market in 2025 now that the MAX has been launched?

Yes. I mean the sternotomy market is something that we anticipate could be a potential market for us, but we're not going to commit to any kind of revenue or guidance on it quite yet. We do think that being able to reduce the time in half that it's going to be definitely be something that is going to be much more approachable for a surgeon to kind of add it to their procedure at that time. That was one of the primary reasons we did it. But it also affects pretty much every other usage of the technology today. We're already seeing it in mini-thoracotomies and regular thoracotomies and people are adopting it very, very quickly. We're not focused in saying we're definitely going after sternotomy quite yet. We kind of want to let it kind of grow organically. Once we get that and we get some more feedback and are people willing to spend any time doing that for the benefit they get, we'll have more to kind of talk about relative to sternotomy.

Okay. And then maybe one on cash flow. You had a couple of quarters of positive cash flow. Angie, I think you said excluding the cash charge next quarter we would have positive cash flow. So I'm just kind of wondering, how you guys are thinking about that moving forward into 2025? Do you think AtriCure is consistently cash flow positive moving forward?

I think on a full year basis 2025 likely to be cash flow positive. The first quarter tends to be very heavy burned. It's just structurally with some of the payments that are made in the first quarter around variable compensation, et cetera, tends to be a heavy cash burn. You've seen that for a number of years now. But on the balance -- and I would just end by saying, really happy with the progress that we're making in this area and expect to continue to be able to enhance our cash flow going forward.

And our next question comes from Danielle Antalffy with UBS.

Congrats on a really strong quarter here. Just 2 quick product questions. One on the AtriClip business. You talked a little bit about the competitive dynamics here. I'm just curious, Mike, if we look at the trend throughout the year, it feels like Q1 was maybe the nadir for AtriClip U.S. growth. And I'm wondering if you would agree with that? Are we past the sort of trialing dynamic here? And maybe you could comment on how you're seeing centers adopt both the clip and the competitive product or have you lost any centers? Any sort of commentary you can give there would be helpful.

Yes. I mean the competition is out there. And as I think I had referred to in one of the questions earlier, Danielle, what we do see is that, obviously, market growth is growing as a result of having competition in the space. That's definitely what we're seeing and why you saw an acceleration overall in ours. Plus, we're also bringing up new innovative products. So you come out with the FLEX-Mini, and I anticipate that's going to also help drive the growth relative to that. We do see them in some accounts. In those accounts -- we haven't lost those accounts completely, they definitely use both of the technologies. I've had the opportunity to kind of meet with many of those accounts, had very nice conversations with them, and they just kind of make that choice on their own relative to some -- whether it's an anatomy or something that they're basically making some personal physician choice on it. But I feel really confident in the quality of our product, the quality of what we bring to the market relative to this, both in terms of the innovations with the FLEX-Mini and with the FLEX V original product, they are just outstanding products. And the fact that we've invested in clinical evidence, which you can see what happened in Europe with the 85 peer-reviewed papers and over 11,000 patients, that is a lot of evidence demonstrating how good the closure rates are and actually even the impact on stroke rates are and so that got us that label over in Europe. And that's a long way for anybody else to kind of catch up to that. And we're running this trial here. I think that we're really making the right types of investments for the long term for this franchise. And the investments aren't just for existing Afib patients, LeAAPS is all about tripling the size of that market and getting to over 1 million more patients that undergo cardiac surgery globally. So we're pretty excited about kind of where we are. Again, we do see the competition, but I think it's really good for us and for the market overall.

Okay, that's helpful. And then just a quick question on another great quarter for Encompass. I mean this Clamp just has really seemed to open up the CABG market, especially for you guys. Just curious about, what you can say as far as where we are from a penetration perspective at this point with CABG now that you've got what's it been like 2 years, I guess, rolling out Encompass here in the U.S.?

Yes, I mean it's a great question. And I do think that we're making impact on adoption for sure of people treating, but we still have a long way to go. I mean we're still -- I'd say that we used to quote call it, that 25% to 30%. We're probably closer to 30% to 35% of the patients today that are actually getting treated overall for cardiac surgery that have Afib, which tells you there's still 65% of the patients that should be treated. All of the guidelines globally, I mean let me repeat that. Every guideline globally from every society, HRS, ACC, EACTS, which is the surgical one over in Europe, ERAS over in Europe as well, which covers all cardiology and also STS, which covers cardiac surgery in the U.S. every one of them have a Class 1A level guidelines for it and that you should be treating this patient population, both with an ablation and with managing the appendage. And so from our standpoint, we think that there's still a long way to go just within that patient population and a lot of growth ahead of us with that. And I think the Encompass Clamp, hopefully, is going to unlock it to make it a lot easier for patients to get treated.

[Operator Instructions] Our next question comes from Suraj Kalia with Oppenheimer & Co.

Congrats on a nice quarter. So Mike, one question for you, one for Angie, and I'll pose the first one to you, Mike. On the surgical PFA products, so Mike, there was a point in time, specifically picking off on Hybrid or Convergent, the whole argument was like, look, Hybrid prevents esophageal fistulas, you can do back wall ablation. So this is additive to existing catheter ablation, right? That was the whole argument. When surgical products have PFA, I guess, help us understand what is the clinical need from a surgical product for a new energy modality. It isn't very obvious to me in terms of how you all are thinking through this. Also, what is going to be the regulatory pathway? Would you all have to do new clinical trials for this new energy modality?

It's a really great question, Suraj. And I think there's a lot of questions to be answered about what the additional clinical benefit is going to be for PFA. As I mentioned, we have great cryo and great RF. We do believe that with obviously all of the excitement around this energy source that it was imperative and important for us to basically bring it into our products as well so we could offer it as a solution. I think -- whether or not it is more efficacious than the cryo or the RF is to be determined at this point in time. When it comes to the clamp technologies, it really, quite frankly, is something that we have to learn through the trials that we have to run relative to going into that area. Relative to the MIS space and putting it on to like an EPi-Sense like type device, that's where speed is going to probably matter a little bit, because you'll be able to kind of take out some of the time relative to that. On the open cardiac side, you can take out some speed, but it's not -- that's not where the time is based on. The time on the open cardiac with the clamps is mostly in getting access to it, not necessarily in the time for using RF per se. That's different on the MIS side. And so there will be a different use case for it from that standpoint. So that's some of the thought process behind it. I think we have to have it. I think it's an important energy to study and to learn about. I believe that the FDA has made it very clear that the PFA technology epicardially will likely have to go down a PMA type pathway. And so we're anticipating -- that's why I say we'll give time lines and guidelines in the future about what that might look like, once we're kind of at that point.

Mike, I appreciate the transparency. Angie, one question for you. What was ASP contribution for the new line of cryoSPHERE probes? I guess, just for pain management, what was the net ASP impact in the quarter?

Suraj, good question. Almost nothing. The majority of the revenue was the cryoSPHERE+. cryoSPHERE MAX, not a big contributor in the third quarter. cryoSPHERE+ is at the same ASP as our legacy cryoSPHERE devices. So when you see 29.6% growth in the quarter, that is all volume growth.

I'm showing no further questions at this time. I would now like to turn it back to Mike Carrel for closing remarks.

Great. Again, everyone, thank you for joining us today, and we look forward to talking to you after the fourth quarter call. Have a great evening. Bye now.

This concludes today's conference call. Thank you for participating. You may now disconnect.