Q4 2022 AtriCure Inc Earnings Call

The conference will begin shortly.

Okay.

Good afternoon, and welcome to <unk> Q4, 2022 earnings Conference call. My name is Amy and I'll be your coordinator for the call today at this time all participants are in a listen only mode.

We will be facilitating a question and answer session towards the end of today's call.

As a reminder, this call is being recorded for replay purposes, I would now like to turn the call over Tumorous device from the Gilmartin group for the few introductory comments.

Great. Thank you.

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

You have not received a copy please call 513.

44448 core to have one emailed to you.

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

Good looking statements are subject to numerous risks and uncertainties many of which are beyond <unk> control, including risks and uncertainties described from time to time and it took care of the SEC filings. These.

These statements include but are not limited to financial expectations and guidance expectations regarding the potential market opportunity for Atrix Earth franchises in growth initiatives, including the adoption of hybrid and therapy and future product approval clearances reimbursement and clinical trial outcomes.

Patrick Yarns results may differ materially from those projected a trickier undertakes no obligation to publicly update any forward looking statements. Additionally, we will refer to non-GAAP financial measures, specifically revenue reported on a constant currency basis, adjusted EBITA and adjusted loss per share.

Conciliation of each non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website.

But that I would like to turn the call over to Mike Carrel, President and Chief Executive Officer, Mike.

Great. Thanks, and good afternoon, and thank you for joining us today too.

2022 was an outstanding year for <unk>.

We executed our plan to accelerate revenue delivering 20% plus growth as we increased adoption across our portfolio of solutions for the treatment of atrial fibrillation appendage management and post operative pain management.

We also drove leverage as a result of our strong topline performance and the expanding scale of our platform.

While making strategic investments to drive future growth.

I am incredibly proud of our team, whose hard work underscores our performance and whose commitment to our mission of improving patient lives led to an impact of over 100000 patients around the globe in 2022 alone.

We ended the year with another strong quarter, achieving $88 million in revenue, reflecting 20% year over year and 6% sequential growth.

Our fourth quarter performance once again demonstrated the depth of many recent catalysts across our markets led by remarkable adoption of the encompass clamp.

<unk> expansion of our pain management franchise and enduring strength across the <unk> platform.

As we progress into 2023, we are reaffirming our commitment to revenue growth above historic rates.

As shown through our guidance of $380 million to $387 million in full year revenue.

We're also reaffirming our expectation to achieve breakeven adjusted EBITDA in 2023 with improvements annually thereafter, as we build sustained profitability of our business.

I will now turn to a more detailed review of our business in the fourth quarter and full year 2022.

Beginning with our open ablation franchise.

Our 2022 performance highlighted the power of innovation at <unk> with the commercial launch of the encompass clamp in the U S driving an acceleration in revenue.

Encompass clamp leverages the proven technology of our synergy ablation system to provide a simpler and faster approach to ablation and open heart procedures.

Momentum from the launch built throughout the year as we rapidly expanded to new and existing positions.

Overall encompass contribute approximately 20% of open ablation revenue in the U S. During 2022, reflecting tailwind from new adoption and additional revenue per procedure upon conversion to the encompass claim.

Feedback from our customers has been exceptional and we are excited for the continued impact of this technology in 2023 and beyond.

Globally, our open ablation franchise saw 18% growth in 2022 as procedure volumes around the world stabilized and we advanced patient treatment.

Well. This is part of our business has been a steady driver of growth for more than a decade.

The market remains vastly underpenetrated and our opportunity is significant.

We are confident in our ability to further penetrate the cardiac surgery market for many years to come.

Yeah.

Innovation is also central to our success and appendage management.

We first entered the market with clearance of the <unk> system in 2010.

Today with multiple enhancements to our technology and unrivaled patient outcomes <unk> system products are the most widely used Elliot management devices worldwide.

With more than 400000 sold to date.

We are pleased with the consistent strength of our <unk> franchise, realizing 20% growth worldwide in 2022 and continued to advance our technology, focusing on less invasive and easier to use devices.

In 2022, we initiated new activities to expand the benefit of appendage management with ATRA clip through our Leafs clinical trial.

We received FDA approval last April to begin this landmark clinical trial, one of the largest cardiac device trials in history with over 6500 patients.

Leaves trial will study the prophylactic use of <unk> devices in cardiac surgery patients, who do not have afib preoperatively, which represents over two thirds of the 1 million cardiac surgery patients worldwide.

The primary endpoint is a demonstrated a reduction in ischemic stroke and systemic arterial embolism laying the groundwork for a new frontier and stroke prevention.

We recently announced the enrollment of the first patient in the trial and are now focused on a major expansion of both trial sites and patient enrollment in 2023.

The Leafs trial will take many years to complete however.

However, we expect awareness for appendage management, and all cardiac procedures to increase in the interim.

Further we believe this trial will provide a meaningful expansion of our addressable market over the long term.

Turning now to our hybrid <unk> therapy or made progress over the course of 2022, increasing our number of accounts by more than 50% since the initial approval.

We are now ramping adoption in 2014 of the 25 top cardiac centers in the United States and interest in developing hybrid Afib therapy.

<unk> remains high.

We are encouraged by the feedback from clinicians and the positive impact of this procedure for patients with long standing persistent atrial fibrillation.

Despite the progress we have made in market development sticky and acceleration adoption is slower than we anticipated.

Cultivating a therapy that requires significant coordination of resources has presented challenges, particularly in an environment, where staffing constraints are impacting hospital systems around the world.

But these challenges are not insurmountable and we continue to believe that hybrid are therapy will deliver accelerated growth in the long term as a differentiated solution for millions of patients.

We have spent substantial time working directly with surgeons, Andy Pease to understand the nuances with logistics required for case growth and to scale those takeaways foster.

<unk> deeper partnership between care teams, along with tactics to implement greater efficiencies across sites.

We will continue to focus on providing comprehensive support for the many programs. We have in the early stages of adoption and expect 2023 to build the foundation for future growth.

Finally, our pain management franchise crowd.

Crowd nerve block continues to be an outstanding contributor to our business delivering 77% growth worldwide in 2022.

We dramatically enlarged our reach in the U S with nearly 600 sites purchasing in 2022 and saw early traction as we launched Crown urbach therapy in Europe and Australia.

Most importantly, we have helped over 16000 patients achieve temporary pain relief after thoracic surgery.

Like our other markets a significant opportunity remains in front of us.

We continue to expand our pain management business with the addition of commercial resources enhanced technology economic studies and clinical data and remain focused on developing crowded our block as a part of the standard of care for management of postoperative pain.

As we have indicated in the past crowd nerve block also shows promise beyond thoracic surgery.

We are actively investigating applications and sternotomy with our existing cryo sphere device and we look forward to updating you on our future progress.

In summary, I would like to reiterate that 2022 was an outstanding year for <unk>.

Our results show that our growth catalysts are diverse and our products offer differentiated and proven solutions in markets with substantial unmet needs.

As we look forward into 2023, we are cultivating both adjacent and new markets by building upon our technology and leveraging the unique position relationships we have developed.

My earlier comments touched on the groundbreaking breaking clinical trial Leafs, which is intended to inform and better define clinical practice and treatment guidelines for stroke prevention in patients undergoing planned cardiac surgery with an elevated risk for stroke.

This trial, if successful unlocks the entire cardiac surgery market to ATRA care, which is well over $2 billion globally.

We see substantial opportunity to leverage the strength of our relationships and cardiac surgery and the <unk> platform for better long term patient outcomes.

I also mentioned the expansion of our pain management business into Sternotomy procedures.

While we are elevating the use of our existing class for device to enhance current solutions and provide temporary pain relief.

The natural synergy between our pain management and cardiac surgery business makes this an exciting opportunity along with the potential to more than double our existing market for pain management.

Additionally, in 2022, we announced that the first patient was treated in the heel Isd clinical trial.

<unk> is studying the treatment of patients with inappropriate sinus tachycardia or ISG using hybrid ablation procedures.

<unk> is characterized by an elevated heart rate and distressing symptoms of heart palpitations contributing to the inability to sleep or exercise.

It affects millions of people around the world and currently there are no effective or approved treatments for this debilitating condition.

We are focused on driving additional sites and patient enrollment in 2023, along with the development of a dedicated device for the therapy in parallel to the clinical trial, we remain excitement excited for the potential of this new therapy to unlock another significant market opportunity and provide a solution to the many patients with ISP.

Treating patients and unaddressed and Underpenetrated markets is at the core of a trickier.

And we have proven our ability to realize meaningful growth from our diversified platform.

We will continue to innovate and research solutions to solve these unmet needs and believe our persistence will yield long term growth in addition to benefiting patients everyday.

I will now turn the call over to Andy Wade, our Chief Financial Officer for more details regarding our financial performance.

Thanks, Mike our fourth quarter 2022 worldwide revenue of $88 million increased 22% on a reported basis.

21, 5% on a constant currency basis, when compared to the fourth quarter of 2021.

U S revenue was $73 9 million, a 27% increase from the fourth quarter of 2021, reflecting healthy activity across product lines enhanced by the continued strength from our launch of the encompass clamp pain management and appendage management products.

International revenue totaled $14 $1 million up 17, 8% on a reported basis and up 25, 4% on a constant currency basis as compared to the fourth quarter of 2021.

Activity in key international markets highlighted by robust growth in appendage management products drove a strong fourth quarter.

Sequentially worldwide sales grew $4 8 million or five 7% over Q3 2022.

Gross margin for the fourth quarter, 2022 was 74% down 110 basis points from the fourth quarter of 2021.

The decline was driven primarily by sales of lower margin products and supply chain and inflationary pressures.

Turning to the bottom line, we are very pleased with our fourth quarter results. We had positive adjusted EBITDA of $6 million for the fourth quarter of 2022 compared to negative adjusted EBITDA of $2 1 million for the fourth quarter 2021.

The improvement in adjusted EBITDA as a result of strong topline growth and moderated operating costs with notable leverage in our selling and administrative spend partially offset by pressure to gross margin.

Our loss per share and adjusted loss per share was nine for the fourth quarter 2022, compared to a loss per share and adjusted loss per share of <unk> 30 for the fourth quarter of 2021.

Now to review full year 2022 results.

Worldwide revenue was $334 million, an increase of 24% on a reported basis and 21, 8% on a constant currency basis.

U S sales increased 21% to $277 $2 million, while international sales increased 17, 7% or 25, 7% on a constant currency basis to $53 $2 million.

The impact from Covid and other macroeconomic environment factors created headwinds early in 2022, but as the year progressed, we saw stabilization in our markets globally.

The commercial launch of the encompass clamp drove U S open ablation sales to $86 1 million or 19% growth over 2021.

As we have noted in previous calls we estimate that the pricing benefit from the from encompass accounts for roughly half of the annual growth with the remaining from continued penetration of the cardiac surgery market.

In 2022, our U S pain management franchise grew 75, 4% to $40 million from increasing activity in existing accounts, along with new account adoption.

U S. Mis revenue was $38 $6 million, reflecting a decline in legacy procedures offset by approximately 6% growth in <unk> sales, where we continue to lay the groundwork for accelerated adoption of hybrid <unk> therapy.

Finally in 2022, we saw strong attachment rates as U S. Appendage management sales reached $112 6 million or 19% increase over 2021, driven largely by our <unk> Flex V device.

Similar to U S trends and activity in 2022, our international revenue growth was propelled by open ablation pain management and appendage management products.

Gross margin for the year ended at 74, 4% a decrease of 60 basis points from 2021. The decline was primarily the impact of inflationary costs and sales mix, where we saw a shift to lower gross margin products.

We continue to explore measures to reduce costs and improve gross margin.

Moving forward to operating expenses in 2021, we recorded an adjustment to the fair value of contingent consideration and the impairment of the IP R&D asset asset associated with the amaze DMA.

After removing the impact of these special items for comparability full year operating expenses were $288 $6 million compared to $253 $2 million an increase of 14%.

The increase in operating costs in 2022 resulted from investments to expand our head count across the organization.

Strategic clinical and product development project spend as well as impacts from inflationary costs.

We are pleased with the leverage in our operating costs in 2022 and remain focused on driving efficiency and SG&A, while maintaining investments in R&D.

Full year 2022, adjusted EBITDA loss was $2 $2 million compared to $8 8 million in 2021.

Our loss per share was $1 <unk> in 2022 compared to earnings per share of $1 11 and 2021.

Adjusted loss per share was $1 <unk> and $1 16, respectively.

We ended 2022 with $173 million of cash and investments on hand, a strong working capital position and the flexibility to fund future opportunities and investments.

Now finally, turning to our outlook for 2023 consistent with our announcement in early January we expect to achieve between 380 and $387 million in revenue for the year, reflecting growth of 15% to 17% over full year 2022 results.

As Mike outlined earlier in the call we have multiple growth drivers in our business globally and anticipate similar drivers leading our 2023 performance.

Exceptional contribution from pain management and continued strong activity in both open ablation and appendage management with very modest contribution from Mis ablation as we strengthen the foundation for long term success.

This last point is important to our outlook for 2023.

While we focus on program development for hybrid <unk> therapy. We believe it has improved it is prudent to reset short term growth expectations for this area of our business.

Our long term expectations are unchanged and ultimately we are confident that our focus and efforts will lead to accelerated growth in mis ablation in the years to come.

We also believe general seasonality trends aligning with those we saw prior to the Covid pandemic will inform revenue cadence in 2023 with first quarter revenue likely to be flat to our fourth quarter of 2022.

From a margin perspective, we anticipate 2023 gross margin to be in line with our recent results with variability caused by geographic and product mix.

We continue to make meaningful investments to support further label and market expansion enhanced reimbursement and innovative product development within R&D expenses, maintaining our R&D spend as a percentage of 2023 revenue at approximately 18% to 19%.

This level of investment contemplates heavy enrollment within our clinical trials as more sites activate in 2023, along with many technology advances across our platforms.

We are moderating SG&A investments in 2023, as we continue to leverage spend and target efficiencies in scale as we grow.

With strong revenue growth a key strategic investments in mind, we expect full year 2023, adjusted EBITDA to be breakeven.

Our investment priorities in 2023 are clear we.

We are balancing the support of our many growth catalysts with overall preservation of capital.

Our focus in 2023 is to advance clinical trials with robust site expansion and patient enrollment enhanced our platforms with new technology, while focusing on improving leverage and profitability.

We continue to maintain a solid balance sheet, which enables these investments in our future growth.

<unk> quarterly cadence consistent with our historical results first quarter 2023 will be a heavier adjusted EBITDA loss that is expected to decrease each quarter as the year progresses, and we achieve our guidance of breakeven adjusted EBITDA for the year.

Further cash burn in the first quarter is normally heavier driven by the timing of variable compensation payments share vesting and other operational needs to start the year.

Our adjusted EBITDA guide translates to an adjusted loss per share for 2023 of approximately $1 14.

To $1 19.

We enter 2023 with determination to expand our patient impact and are thoughtfully managing our business for long term success.

At this point I will turn the call back to Mike for closing comments.

Angie 2022 was a strong year across the company and in many ways began the next phase of <unk> course, as we continue executing against the significant market opportunities in front of US while also thoughtfully investing to expand our markets and impact to adjacent patient populations over time.

We are building upon the foundation, we have created together over the last decade by continuing to innovate with a long term growth mindset.

<unk> of our business today and in the future will ensure success in 2023.

And over the coming decades, and will and we will continue delivering on our commitment to revenue growth above historical rates.

We are just as excited to showcase the benefits of our expanding scale and operational planning as we start to calculate a balance between investing for the future and our profitability and with that I will turn it over to questions operator.

As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please limit questions to one and one follow up at a time and then return to the queue for any additional questions.

Please standby, while we compile the Q&A roster.

And our first question comes from Robbie Marcus with Jpmorgan. Your line is open.

Hi.

Thanks for taking the questions congrats on a nice quarter.

Maybe to start.

MS commentary was new in a little bit disappointing to hear in the short term I was wondering if you could spend a bit more time on it.

Why has it fallen below your expectations for growth.

And how long do you think it will take to start to resume back on track with where you thought XP.

Really fair question and we feel the same way overall about the mis business in terms of kind of where we are obviously the data from that came out from the converge trial has been exceptional more and more data continues to come out clinically to show that when you add epicardium ablation to the endocardial ablation it actually benefits a lot more in endocardial by itself.

Just does not work on the long standing persistent patient so in the face of this great data that's out there and continue as why is it taking us a little bit longer to get up and running I think it is a very fair question for us and really it comes down to some of the comments that I made Ravi on there which is that the logistics are proven to be a little bit longer to kind of get that stickiness going there isn't pushback on weather.

Not this is going to benefit patients and whether or not this is going to be something that long term, we're going to have a lot of patients are going to come through the funnel. It has more to do with really getting surgery and electrophysiology and their groups working very closely together.

And getting that patient flow in and having that confidence and then not just kind of I'd say, a global kind of thing that we're kind of facing relative to that on top of that.

We underestimated the impact of coming out of Covid and honest and the staffing effect of when you are trying to coordinate to different groups like that getting people to kind of get their attention and get the staffing to work, where if you get the attention of upfront because we had a lot of activity even during COVID-19 to get sites up and running and training, but then to get them to do the <unk>.

Good work of actually working through the logistics and working through how am I going to move that patient through the process. That's the part that's taken us longer than expected I do feel like we've got a really good handle on it now, but it's going to take us a little bit longer and I think ramp up on each of the individual site is taking us a little bit longer on that side of it which is why we've set guidance this year.

Above our historical numbers at that 15% to 17% and feel really good about that and that includes a week.

Hybrid number and so obviously, we would love to see that come back faster I can't give you an exact quarter day, but hopefully it does and that we have some upside to those numbers at some point. In addition to upside that you might get relative to the other really fast growing parts of our business, but even with a weak hybrid aspect of it in 2023 from a revenue side, we're going to make a ton of.

Dress in the sites and I feel like it really is going to accelerate our growth long term on that side.

Great I appreciate that and maybe the dovetail with that now with lower <unk>.

Miss expectations, maybe you could speak to the different business line items, and how we should be thinking about reallocating that revenue within the guidance range through the year.

I appreciate it thanks.

I'll go through each individual franchise. So when you think about the open ablation franchise I think the beginning part of this year.

We're going to continue to see really good strength at the open as we kind of lap that one year from rolling out encompass we are seeing great traction in that part of our business. It has exceeded all expectations that we had internally.

We feel really good about adoption, we're saving time, and we're making a lot easier for surgeons that otherwise were not performing cardiac surgery ablation has on their patients and those patients getting benefit and so it's kind of met that mark and beyond and we think that there is a lot of there's a lot of room for growth both in 2023 and beyond on that particular side, so that's going to be definitely.

One major growth driver number two is crowd nerve block continues to be a very robust growth driver for us we're going to continue to add a lot of new people into the business in that part of our business because we need help on case coverage, it's really expanding as I mentioned, we're in over 600 sites today and.

And we have Matt and we're just beginning to penetrate that market not just in terms of number of sites, but the physicians and all the different procedures. So we think that thats going to be another robust growth year for us overall, maybe not at the same percentage growth, but we do think that it is going to be a really nice strong growth year for us.

We're not including really much into our guidance relative to Sternotomy as I mentioned on the call. We're really excited about sternotomy.

But we're really doing we're laying the groundwork this year, so that next year and beyond it's going to be sticky revenue for a really long period of time, and we know that market incredibly well because as I mentioned in my script, we have relationships with pretty much every single cardiac surgeon in the country. So it's a really it marries very well with our cardiac surgery team also and they are really working very <unk>.

<unk> in the field and then quick continues to be a very strong driver for us of kind of overall growth for the business and feel like that's going to be a solid performer for us so kind of in that order I would say are some of the big growth drivers for us. This year and then internationally. We've definitely seen as you kind of saw this quarter, we're starting to see that become a more meaningful part of our business and we feel like that is.

Going to continue into 2023, we put new leadership there are a couple of years ago kind of right before COVID-19 and we're starting to see the real tangible benefits of that both in Europe and in Asia.

Great. Thanks for taking the questions.

Yes.

Thank you one moment for our next question.

And our next question comes from Matt O'brien with Piper Sandler Your line is open.

Hi, This is Sam on for Matt Thanks for taking our question.

I guess.

<unk> off.

Could you give us a little bit more information on pain management, obviously it was a good growth driver last year coming in about 75% what can we expect.

Moving forward and how could this play out throughout the year.

We expect definitely continued growth in that market. We are at about 60 people or so now if you look back about four years ago. We were sitting there was we were just kind of getting that therapy started so we've kind of gone from four people to 60 people over the last four years, we're going to add more people to that group because case volumes continue to grow.

Every week as we open up new accounts and get deeper and deeper into those accounts as I mentioned, we're not going to see the same percentage growth I think that the numbers are just getting larger from that standpoint, but we do anticipate that we'll still see robust growth within each of those individual accounts as we scale that business.

I don't know if thats, what youre looking for if you are looking for more detailed than that I'm not sure where to go with it.

Guys. Thank you I guess, one more for Matt.

And I think a lot of it was covered previously but would you be able to just give us a little bit more information on on what convergent dead.

This past quarter and when do you could you estimate when we could see some sort of inflection point in the future.

Yes, Sam I'll start with what converged in the fourth quarter were down slightly year over year, but if you recall the fourth quarter of 2021 was one of our strongest on record. So we were down sequentially and down year over year in the fourth quarter. We saw good activity within the overall number of accounts, but I think.

The the challenge that we're seeing within accounts of look being able to do procedures repeatedly.

Kind of a mass scale meeting, reaching a bigger number of patients throughout the quarter and the year has definitely been a challenge in the logistics and the workflow within program development that Mike referred to earlier.

And as we look at inflection points.

We're not I'm not ready to give you a date what I can tell you is this is that from the feedback we've gotten from both Electrophysiologist cardiologists and surgeons they want to build programs. They want to put it from the time and effort, but it does take more time than we had expected. So I can't predict the exact date, what I can what I can share with you is I absolutely believe this is going to be a.

Growth driver for us from now through the end of the decade. This year is going to be a little bit tight as we get these sites up and running but there are millions of patients that have long standing persistent atrial fibrillation and study. After study paper. After paper shows that if you add epicardium ablation to endocardial ablation. These patients do at least twice as well.

And are much more durable from in terms of the lesion set than just the endocardial by itself. So the combination is really powerful.

And more and more data is coming out to prove that and so from our standpoint, we really think this is going to be sticky long term, even though this year is going to be a building year for us.

Great. Thank you so much.

Thank you one moment for our next question.

And our next question comes from Bill <unk> with Canaccord. Your line is open.

Great. Thanks, Good evening can you hear me okay.

Yes perfect.

Great. Thanks.

So just piggyback on that last question.

The commentary of.

Foundational year Youre building it I think expectations had been probably in the 20 or 30% to 40% year over year growth rate.

You're building it does that mean, it's a flat year does that mean, it's up 10%, 20% how do we think about the growth in the year you are building and what specifically are you focused on with the accounts because I think one of the other words it keeps popping up as stickiness. So it seems like Youre getting accounts started and then they might trail off so.

Just kind of curious what that expectation is and then how you get to it.

Yes, It really fair question. So there is the when we built our guidance for the year and I think that's the most important thing to really think about is that when we built with that 15% to 17%. We are assuming that our hybrid business is well below that that's kind of the way to think about it and that the other businesses are driving the growth for the business and so our hope is obviously that there is some upside to that at some.

Point and that these sites get sticky and they kind of really begin to drive that logistics and get the patient flow through and get those case volumes to be kind of more consistent across the board, but in absence of having the consistency yet I'm not ready to kind of commit to being at that near that corporate growth rate at this point, so it's going to be below significant below that corporate growth rate and terms.

How we built our guidance up and then obviously that tells you that the cryo nerve block and the clip or likely above that and that the open ablation is going to be having a solid year. We have historically said on the open ablation side that you are sitting in the tune of kind of the high single digits, obviously, we've exceeded that quite a bit this year.

And from an overall standpoint, it's going to be above that overall, but maybe not quite as growth as you'd see on the crowd and robot side.

Okay, and then a follow up on expenses Youre SG&A I mean, that's a pretty interesting to see it dropped nominally.

From Q2, and Q3 in the highest revenue quarter and I'm just curious if there's any one time benefit that you received in the fourth quarter or is this.

More of the baseline we should be thinking of for the future and those are my questions. Thank you.

Bill There was one time, one onetime item one benefit of a collection of our receivables that had been reserved.

Several years ago to the tune of roughly let's say $1 million that benefited the quarter. We also saw in some cases better leverage of our spend in some of the areas that had cut against us on the expense side travel is one that comes to mind, just a little bit favorable.

In the fourth quarter I think as you look back historically the pattern on SG&A spend would say look it's a higher percentage to start the year and then moderates as the year goes and part of that is we feel like we're entering the year with really good investments kind of globally within the sales team, but we'll be selective about adding Mike touched on a couple of areas.

Within our cryo nerve block team and in our international teams will continue to add in a little bit more on the case support within cardiac as well we feel like we're entering the year with a really good and solid team that can drive robust growth for the year.

Great. Thank you.

Thank you one moment for our next question.

And our next question comes from Mary <unk> with <unk>. Your line is open.

Hi, Mike and Andy Thanks for taking the questions. This evening.

Wanted to ask one here on open ablation I want to understand how far that growth can be sustained I know in the past you've given us some details like.

Making up 20% of revenue in 2022.

No that price uplift as well as volume has have both contributed to that growth. So I wonder if you can help us understand where we are in terms of.

Reach with that device how many of your accounts if you have gone into that with all of your accounts.

And how much longer kind of some of this price uplift can continue.

Yeah, I'll start and then I'll, let Andrew you kind of follow up on some of the pricing questions.

We think about this market I think we're in the really early beginnings of it when you think about the cardiac surgery market and the Afib treatment. There, we're still as an industry only treating 28% of those patients and the best numbers more and more data is coming out to say that it might even be less than 28% treatment. Yet it is still a level one guideline across <unk>.

All of the societies and one of the big pieces of feedback that we received was how do you improve that well. The number one thing was you needed to make it easier to perform for surgeons that don't normally get behind the heart and so and.

Encompass which has been in development for over four years and is now on the market was really targeted towards that audience to kind of do a very robust ablation.

For those patients and make it much easier for them to do it and to get behind the heart by going to the oblique in transverse sinus and then combine that with making it a little bit quicker and we've seen all of those benefits and so we think that our goal is to take that 28% and hopefully we're going to get to over 80%. Some Sunday of patients that are undergoing cardiac surgery.

They are getting treated and so I think we've got a huge market in front of us significant opportunity that sits there.

And how that applies to our growth I don't want we're not getting too far ahead of ourselves and we put our guidance at 15% to 17% just because we've only had on the market for six to nine months really aggressively and so we kind of wanted to see how that shakes out this year.

Or we can kind of give me more long term what it could look like on an annualized basis, but we are feeling very confident in the sense that it's working really well surgeons that we're not using any product to do any ablation are now doing some ablation and helping these patients out other surgeons are finding it easier to use and some of the other products and devices. We had so we're kind of able to expand in multiple different.

Ways and we're learning as we're rolling it out so it's been a great product received very well and I think that we've got many many years ahead of us of strong growth with that and hopefully we'll get ourselves to 80% and help these patients out for a long time, yes Marie in terms of the rates were in just over a third of accounts as we accounts in the U S. As we ended the year in a pretty high conviction rate.

When you think about the number of accounts that started early on in the launch that have continued to order throughout the year and then we will lap the launch benefit really in the second half of 2023 win when encompasses a more meaningful percentage of the open ablation revenue.

Okay. That's really helpful. Both of you. Thank you I guess I'll ask my follow up here on the cryo.

[noise] expansion you mentioned, you're doing some exploration of Sterne <unk>, what does that look like and when might we start to.

Some more meaningful revenue from the eastern Army opportunity and can you also remind us on sizing of that market. Thanks a lot.

So I'll start with the sizing so we've been looking at the strong end market for several years and we've been studying.

How much pain is there what is the difference between the sternotomy pain versus the thoracic pain and what we are start we got feedback from a lot of our customers that they believe there is a tremendous amount of benefit to add this to their kind of cabot's procedures or theyre sternotomy procedures overall theres about 255000 cabinets procedures in the United States alone.

To just give you a relative comparison, there's about 140 to 150000 thoracic procedures. So it increases more than doubles the size of the overall market opportunity for us and so thats, obviously fast and we have relationships with people performing that surgery. I mean, we have relationships in almost every one of those accounts in the United States and globally and so we've got very.

Good ability to penetrate and have access into that market.

The way that we're rolling it out as first over the last year or so we've really studied how does it work due to freeze times work, where should we bled like clinically, making sure that before we roll it out to everybody that we understood that it could be safe and effective and really benefit patients first and foremost. So our team has really done deep dives with kols around the country.

Test it out and learn from that.

The next step is the phase that we're in right now, which is we're going to roll it out to a select number of sites. So that we can learn from those sites about the best application for it it is different and thoracic in terms of it's a different part of the nerve. So what do we learn from that how long does the benefit last for that patient in terms of helping them get to the hospital and improve their overall pain scores in <unk>.

Such as that so those are things, we're going to really study and these first really small number of accounts over the course of the next six months or so based on that feedback the back half of the year, we will begin to rollout a little more aggressively and then really go into a big launch early part of 2024.

Alright very helpful. Thank you.

Thank you one moment for our next question.

And our next question comes from Mike Matson with Needham Your line is open.

Yes, thanks for taking my questions I wanted to ask one.

The gross margin.

So Angie I think you said you expect it to be flat in 'twenty three.

Hey, Blake.

So potential for some inflation in some of the mix issues that you had in 2002.

Carry into 'twenty three.

That's right Mike as we exited 22 I think the last two quarters, we were hit a bit more by cost increases kind of across our supply chain and as encompassed in cryo sphere became a bigger percentage of our overall revenue and we saw some really nice activity in our international markets that does come with a bit of a hit to the gross.

And so our expectation is.

Think about 2023 pretty close to where we've been kind of more recently in the $74, 75% range, but with upside as the team continues to really evaluate ways to lean production encompass for example will be in our first full year of production here coming up in the spring and have targeted areas really to reduce costs and lean out.

Costs within both that and then our cryo sphere probe.

Okay, but just to be clear evening, you still think it can be flat EBIT.

And some of those issues maybe remaining in place.

Yes, correct.

Okay.

Then I want to ask one about the international business.

The strength there.

Maybe you could talk about are there any more opportunities to enter new markets.

I wanted to take your temperature on.

China and kind of.

What are you seeing there.

Do you see any risk of the value based purchasing affecting either.

So our international business as I briefly mentioned was really we put new leadership in place several years ago naturally had a positive impact on just the overall acumen and how we're going to market throughout Europe and Asia as it relates to Europe I don't know if there is any new markets. We can go and we're pretty much in every market in Europe , whether dirt.

<unk>.

Or on a distributor basis, we've got very good.

Prospects there, but the biggest piece of growth prospects is that we're really at the early early stages on the hybrid therapies and on cryo nerve block just started there and so we've seen really strong growth and solid growth on the clip franchises as well and so I would say that theres opportunity in all of that quite frankly throughout Europe . The penetration rate on the open side of our business is even lower in Europe than it is in.

United States. So we think that there's even more opportunity there long term, we don't have encompassed there yet we're working on that we think that several years out but.

But there is more awareness that they need to be treating in there. So I think theres a lot of good growth and now that we've got really strong and solid leadership. There I think we can make some really good inroads there in the Asia markets, we saw great growth in Australia. This year.

One of our big growing portions of our market Japan continues to be a solid contributors are number two country in the world with many of our products and lines China has been.

Surprisingly has actually been a reasonably kind of solid it's not like decreasing but it's also not increasing so it's kind of in a solid market for us we've only got our RF products. There today. So we don't have an expansive portfolio were working on that but we still think it's probably several years ahead before we start to see some growth coming out of back out of China, but at least as an eight.

Very solid place with three years ago, It was not as solid and a little bit more volatile and today I think we're in a very solid placement of really strong market share and a strong presence with the distributed we have there.

Okay, great. Thank you.

Thank you one moment for our next question.

And our next question comes from Suraj Kalia with Oppenheimer. Your line is open.

Mike Angie can you hear me all right.

Yeah, Hey, Suraj, perfect Hey, Mike So.

Just picking up on some earlier questions. So the stronger outlook for open.

And the lukewarm outlook for hyper Ed in your prepared remarks.

Somewhat counter intuitive and I was wondering if you could just juxtapose you and Ive talked about this all final so but I would love for you to juxtapose.

How do you see any potential indication creep from PFA.

And if if your.

Outlook.

If capital also has anything to do.

With the way Youll see open versus hybrid moving forward.

Yes.

PFA and capital have absolutely zero impact on our both short term business and in fact, I actually think they're going to be long term very beneficial to us the data that came out from capital.

As as I know you that you've looked into basically says that the endocardial catheter by itself on long standing persistent patients does not have long term durable effect and the numbers were almost identical to what we saw in the converge trial in that arm of the trial and the converge arm of the trial, we saw a significant.

<unk> improvement in durability with that so we think capital is incredibly supportive that for these most difficult to treat patients for these long term.

Patients that converge in all the papers that have come out afterwards that capital of further supports that when you add up a cardiome relation to endocardial ablation, you'll get a better long term results and endo by itself is not effective and that were complementary to it. So I actually think that that's actually made me even more bullish.

Not necessarily this year, but really more as we look long term and as we get these logistics worked out. This year is all about logistics and workflow not about data because the data supports that we should be growing even faster and I believe that that data is going to be an effect as we look at $2024 25, and 26 once we get through all.

All of the workflow that's out there as it relates to PFS again, I think it's complementary I think PSA is a great and really interesting technology. It is out there to improve speed.

And improved safety and be close to the same effectiveness as RF and cryo and.

And almost all of the initial devices are being tested and worked on and looked at where mostly PDI and some of them are beginning to obviously as you know look at some of the poster wall I think theyre going to run into the same efficacious result, youre going to see with cryo and RF. When you look at it on the.

And when you look at the posterior wall.

We just came out from Europe called the manifest study and when you look at that data, it's very clear that in paroxysmal and even early persistent patients.

PFA works reasonably well at one year actually very consistent on the result relative to RF and cryo and so the physicians and that has nothing to do with our business such as <unk>.

That's not that we're not in those markets per se today, but what it does demonstrate is that its reasonably close on applications and then people are going to have to make decisions upon the speed and the safety aspect of it as more and more data comes out but if you actually look in the details of that study. It shows that at one year is there's a significant drop off in the long standing policy.

Just in patient population and those patients got a posterior wall ablation and so I think and those numbers again are very consistent with what you see in all the studies that we did with converge and other studies that have been out there for years around trying to do just endocardial ablation, so again that to me.

It that our epicardium ablation is complementary to PFA to cryo to RF and it really quite frankly, Emboldens me for our long term growth prospects again needing to work through some of the logistics in the short term.

Fair enough one other question, Mike So Mike maybe I'm jumping the gun here on lips.

There is information you are not in a position to share I can appreciate that so one of the endpoints you mentioned, Mike was thrombin was.

If I remember correctly systemic embolism.

And just given the idiopathic nature of thrombus formation in these patients Mike.

Would you reliably hypothesized event rates.

Additional color there would be great. I mean, you can you can.

Okay.

I'm curious how do you prevent or account for everything else systemically.

You might have nothing to do with what you guys. How you guys <unk>. Thank you for taking my questions.

It's a really fair and great question and one that we studied quite a bit in the design of the trial. When you look at when you get a sick atrium, whether its caused by atrial fibrillation or caused by any other source like heart failure that that atrium is not operating correctly, which allows for the blood to begin to pull on the natural place for that the pool is in.

The appendage and so not only have we hypothesize, but when you looked at the Atlas study or you look at that we did with 562 patients and albeit it was only one year outlook and did not have a strong it wasn't powered for the full piece of this you combine that with other data that's out there about kind of heart failure patients and their stroke rates relative to after cardiac.

We've been able to kind of come to a really good rate to basically enhance that and look at the patient population that is at a high risk of having basically a week atrium, whether caused by atrial fibrillation, because theyre likely to actually get a fib are caused by heart failure and Mechanistically. We believe that that is going to lead to a higher stroke rate and pace.

<unk> when they don't have that appendage, because where does the blood pool, the blood pools and into the appendage and we do know that and we do know that the appendage the source of that because of the trabeculation off the appendage and quite frankly, just based on the way that it is situated around the heart. So we feel very confident that this is going to be a positive result is obviously a long trial.

And trials have to be proven over a long period of time. So there's no guarantee on that front, but it's a combination of a lot of that data that I just described.

Put together and over the course of researching over the last four years that we feel very confident that this is going to be a successful trial.

Thank you.

Thank you one moment please.

And our final question is from Rick Wise with Stifel. Your line is open.

Hi, Good evening, Hi, Mike Hi, Angie.

Just real quick for me.

One just on the macro picture.

The only.

Aspect I think of your comments, if I heard correctly Mike.

You talked about some of the macro headwinds we're all familiar with we don't haven't really mentioned much was staffing constraints relative to converge.

Just was curious.

We've heard from a lot of companies so far at the start of the year do you feel like macro pressures like staffing are.

Getting better or getting worse or stable how are you thinking about and the same thing maybe it's more for energy on the sort of cost inflation side.

Youre getting after some of those as you said the LNG, but.

But are things getting worse or slowing down.

Just as we start the year wanted to frame that.

Yes, as it relates to staffing I would say that it's not getting worse or better I would say its relatively stable with most of the end of last year my comments around staffing relative to us very specifically with it I think we underappreciated the impacts coming out of Covid that the staffing constraints would have on starting new programs and getting.

Their time to work on the logistics and work through how they were going to Handoffs and care for that patient and that was that was a little bit of.

A miss on our part relative to kind of thinking through the expectations coming out of Covid and omicron and as we're kind of kind of ramping back up but overall, though I would say that they're relatively consistent theyre not getting worse at this point in time by any means for us I just think we need more time to get through kind of on the converged side to kind of ramp that back up and get the logistics to work and there is still some there are staffing constraints.

They are out there that do impact kind of getting their time and energy.

Rick on the cost side I would say from the supply chain area. We feel like we've got good visibility at this point and kind of can understand kind of where the costs are coming from with our key suppliers I do think that we exited the year feeling a bit more relief in some areas such as travel where it's early in the year I think that the pricing that we were seeing the cost just.

Overall relative to our teams travel was getting a little bit out of hand, so kind of a mixed there I'd say feeling better from some of the areas, where theres a little bit more discretionary spend and kind of have a handle on where the suppliers are coming in and longer term basis.

Great and just one small follow up really.

Mike given the significant investment in clinical trials.

It seems like it's obviously a significant.

An important investment.

How do we think about R&D expense going forward.

Do we.

Because of some of this spending could.

Could we get back towards 20% of sales.

That we saw.

I think it was 2020.

Hi.

Okay.

Does the $1 move higher than we saw last year, how do we think about modeling R&D. Thanks a lot.

I'll, let Andy answer the modeling question, but maybe philosophically I think I just want to make sure I lay of the land on when we think I mean.

I believe that.

One of the things that we do well and that we're going to continue to do well over the next coming decades has expanded in new markets, where patients are undertreated today and find therapies for them to be treated whether it's as we talked about with leaps investing there <unk> I talked about.

Not in use or new markets. They are in market expanding with existing products that we basically have today in clinical trials actually help kind of define what that success could look like in a market expansion opportunity. I think these are things that allow us to be a really robust and kind of big company over the course of the next decade, or so and really expand that mark.

Get into multiple billions. So that's why we're making the investments and we're uniquely positioned because we're going to be the first to market in the first into those areas and we think the clinical differentiation differentiation, but it's also we believe science matters in terms of actually getting the right level of adoption. So that when physicians are making decisions there.

Making it based on the scientific evidence that is out there with that ill turn it over to Andy to talk maybe more details about some of the numbers, yes, Rick our prepared remarks, we said for the year expect about 18% to 19% R&D spend as a percentage of revenue I think quarter to quarter based on pace of enrollment you may see a little bit of variability.

That number, but we think in the near term over the next couple of years with the lens of clinical trial.

Expansion of the clinical trials and our commitment to continuing to advance our technology platform that R&D as a percentage of revenue will stay in the upper teens.

Thank you.

I would now like to turn the conference back to Mike Carrel for closing remarks.

Great again, thank you everybody for joining us after an outstanding 2022, we look forward to demonstrating the sustainability and growth engine that we have here at <unk>. Thanks for joining us and for your interest in our company have a great one.

And this concludes today's conference call. Thank you for participating you may now disconnect.

The conference will begin shortly to raise and lower Johan during Q&A, you can dial star one one.

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