Acutus Medical, Inc. (AFIB) on Q4 2021 Results - Earnings Call Transcript
Operator: Good day, ladies and gentlemen. And thank you for standing by. Welcome to the Acutus Fourth-quarter and full-year 2021 Earnings conference call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. . It is now my pleasure to introduce Caroline Corner, Investor Relations.
Caroline Corner: Thank you, operator. Welcome to Acutus' Fourth Quarter and Full-Year 2021 Earnings Call. Joining me on today's call, are Vince Burgess, President and Chief Executive Officer, and David Roman, Chief Financial Officer. This call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements made on this call that do not relate to matters of historical facts, should be considered forward-looking statements. Factors that may cause results to differ from these forward-looking statements are discussed under the Forward-looking Statements Section in the press release attached as an exhibit to Acutus’ Form 8-k, filed with the SEC today, and are also discussed in more detail under the risk factors section, in Acutus’ most recent filings with SEC, including the risk factors described in Acutus’ Form 10-K. Any forward-looking statements provided during this call, including projections for future performance are based on management's expectations as of today. Acutus undertakes no obligation to update these statements, except as required by applicable law. Acutus’ press release of fourth-quarter and full-year 2021 results is also available on the Acutus website, www.acutusmedical.com under the Investors Section and includes additional details about Acutus’ financial results. The Acutus website also has Acutus’ SEC filings, which you are encouraged to review. A recording of today's call will be available on the Acutus website by 5:00 PM Pacific Time. Now, I'd like to turn the call over to Vince, for his comments on fourth quarter and full year 2021 business highlights.
Vince Burgess: Thank you, Caroline. And good afternoon to everyone joining us today. During today's call, I will review clinical and commercial highlights, provide a brief overview of our fourth quarter and full-year top-line results, and go into further details around our strategic priorities and the steps we're taking to improve the Company's financial performance. David will follow up with details on our financial and operational results, as well as our outlook. Amidst fluid market and business conditions, we continue to make progress in each of our three core technology areas, access, mapping and therapy guidance, and therapy. heart access product line continues to be very well received by electrophysiologists and structural heart specialists as we continue to expand and refine our product offerings. access portfolio now includes crossing devices and sheets upended for use across multiple procedure categories. And in conjunction with many of the most popular access in therapy offerings on the market today. Most recently, we received FDA clearance to market crossing devices that pair with the Boston Scientific true steel sheath, which is used to deliver the watchman Left Atrial Appendage closure device, as well as the Merit Medical heart span sheet. Continued portfolio expansion and increased focused on our left hard access line drove the business to more than triple on a year-over-year basis during the fourth quarter. And we expect continued growth here in 2022. In mapping and therapy guidance, we continue to see positive reception of our unique in the industry AcQ track region of interest, finder software suite, capabilities inherent in the software allow physicians to rapidly identify potential sources and sustainers of arrythmias. The unique single beat hold chamber mapping capabilities were recently highlighted in a paper out of Erasmus University in the Netherlands, where patients generally viewed as untreatable at Ablation were successfully treated quickly and with relative ease using AcQMap. We've also recently initiated a program to develop and integrate sophisticated and improved navigation capabilities into our AcQMap Mapping Console and Ablation Catheter. Enhanced Catheter localization, navigation stability, and accuracy are important customer needs and critical features that will further improve the physician experience with AcQMap. Turning to therapy are AcQBlate Force Sensing Ablation Catheter and System continues to gain commercial traction in Europe. And our customers and clinical support personnel report a markedly improved user experience in cases where we integrate our mapping technologies and our own ablation catheter and system. We now have 18 therapy systems installed with direct customers in Europe in addition to our systems in place in the U.S. to support our therapy clinical trial. AcQBlate catheter sales annualized at over a million dollars in Q4 and therapy catheter penetration of our mapping procedures exited the year at just over 60%. Year-to-date, we are seeing further increases with penetration hovering around 70%. Regarding AcQBlate in the U.S., we are nearing completion of our enrollment of our right atrial Flutter Ablation trial, and we expect to complete our PMA submission in the coming months. This should allow us for U.S. FDA approval in early 2023. We're also making good progress on our Pulsed Field Ablation Program and earlier this month enrolled the second cohort of patients in our CE Mark trial. We have now treated over 20 patients in the AcQForce PFA CE Mark study, and we're on track to complete enrollment and follow up this year. We are encouraged with the acute procedural results and a further refined our dosing strategy to optimize clinical outcomes. We expect this trial to help inform our US IDE strategy. And we will provide more specifics on timeline throughout the year. Turning to our fourth quarter, 2021, and full-year results, that revenue of $4.4 million for Q4 grew approximately 70% year-over-year, led by procedure volume growth in our business outside the United States, higher capital equipment sales, and new product launches. For the full-year, net revenues of $17.3 million in 2021, grew approximately 100% year-over-year. This growth was registered across all geographies and product categories, including increased adoption of our mapping system and platform, higher capital sales, the launch of our therapy product line outside the U.S., and Lepton (ph) access. We ended the fourth quarter of 2021 with an installed base of 77 AcQmap systems Consistent with disclosure on previous calls, we are strategically removing and repositioning certain systems with below target utilization. Further, as we identify any potential new AcQMap sites, we are more carefully aligning those systems to our revamped commercial pod structure to improve company economics, as well as to ensure consistent and reliable case coverage and improve overall customer experience. As a result, our global net installed base could decline modestly here in the first half of 2022. For the full year of 2022, we expect to show marginal growth in our net install base, while increasing procedure volume growth and utilization within serviced accounts. Moving to procedure volumes and disposable sales during Q4, global mapping procedure volumes advanced 22% on a Year-over-year basis. In the U.S., procedure volumes were down slightly in Q4 versus the prior year. I would note however, that we are seeing improvements in the U.S. procedure trends here in the first quarter of 2022. Our businesses outside the U.S. drove record procedure volumes in Q4, as customers adopt our integrated mapping and therapy platform. In total, Q4 global disposable sales grew 38% on a year-over-year basis, with all major product categories: left heart access, mapping, consumables and ablation, contributing to this performance. Over time, generating recurring consumable revenue will drive our business, and we are seeing receptivity to our innovations and uptake of our product portfolio. Overall, global disposable revenue grew over 75% in 2021 to nearly $12 million as adoption of our mapping system and catheter was further augmented by new product introductions in left hard access and therapy. To close on my remarks, I would like to discuss our strategic priorities, as well as the restructuring we announced earlier this year. Exiting 2021 and considering business and market conditions, we undertook an intensive strategic planning process where we identified three broad action items that will guide our business going forward. First is to narrow the scope of our product development programs to those that will carry our business the next three to five years and to more exploratory work. We continue to see very high levels of productivity out of our R&D, clinical, and regulatory teams. And we need to continue to set them up for success. To that end, virtually all of our energies from a development perspective are now focused on enhancing user experience with our mapping system via workflow improvements and improve localization and on integrating therapy, including RF ablation in the U.S. and ultimately Pulsed Field Ablation globally. Second, is driving our commercial teams to focus on the market development and utilization of the AcQMap mapping system and associated disposables. Achievement these objectives requires us to be even more focused on converting electrophysiologists to regular use of our system in their complex procedures. This will enhance familiarity, drive adoption, advocacy, and ultimately procedure volume growth in utilization. In the near-term, this intense focus on driving utilization of existing consoles will likely come at the expense of installed base growth, but this is required to cement our place in this field. As we execute this strategy, we're pleased to see growth in procedure volumes on a year-over-year basis, here in the first quarter of 2022. And third, is to strengthen the financial position of the company and improve operational performance. This involved several components, including reduced operating expenses, tighter controls on working capital and capital expenditures, and an intensified focus on gross margins. The restructuring we announced earlier this year is expected to drive annual -- annualized pretax, non-GAAP savings of $23 million to $25 million, as well as a 30% to 40% reduction in quarterly cash burn exiting this year. As previously disclosed, we started to realize the benefits of our restructuring efforts late March as our actions fell under the worker adjustment and retraining notification act and required a 60-day notice period for impacted team members. Lastly, to augment our organic initiatives, we have retained several specialized third-party consultants and advisors to review our strategy as well at a range of options to fund our long-term growth, including non - dilutive financing, partnerships, licensing, and distribution agreements. I'll now turn the call over to David to review our financial results in more detail. David?
David Roman: Thank you, Van. And good afternoon, everyone. During my remarks today, I will provide details on fourth quarter and full-year 2021 operating results as well as our outlook. As I discuss our results, I will reference our updated presentation of sales -- sales results and key business metrics that is included in our earnings press release and on Form 8-K, filed today with the SEC. A reconciliation of our GAAP to non-GAAP financials is also included in this filing. I will be discussing our financial results on a non-GAAP basis during this call. As Vince previously mentioned, our revenues for the fourth quarter of 2021 were $4.4 million, up from $2.6 million in Q4, 2020. Sales in the U.S. of $2.1 million advanced 31% compared to the prior year's fourth quarter. Increased capital equipment and left heart access product sales drove U.S. performance. Sales outside the United States, which included revenue through our distribution partner Biotronik, were $2.3 million, and compared to just under $1 million in Q4 of 2020. The year-over-year growth in our O.U.S. businesses was driven by higher mapping procedure volumes, the launch of our AcQBlate Force Sensing Ablation Catheter and System, and capital sales. By product segment, capital sales of $761,000 were up from $175,000 in the fourth quarter of 2020, driven by the conversion of AcQMap's systems from evaluation to long-term capital placements through cash sales and catheter commitment contracts. Disposable product revenue of $3.2 million increased 38% on a year-over-year basis. The strong performance in disposables was led by international markets, where electrophysiologists have access to our full suite of therapy products and benefit from our integrated Mapping and therapy offerings. Service and other revenue of $352,000 was up from $46,000 in Q4 2020, driven by higher revenue from service contracts and console rentals. As in prior quarters, we continue to face headwinds at the gross margin line. Our historical decision to seek maximum vertical integration and pursue a broad product line, maximizes innovation and agility. At the same time, the impact of this strategy and gross margins is significant until revenues are at scale. For the fourth quarter of 2021, non-GAAP gross margin was negative 119% compared with negative 84% in the fourth quarter of 2020. The year-over-year change in our non-GAAP gross margin primarily relates to recognize manufacturing variances, higher field service and freight expenses, higher depreciation associated with placed equipment and warranty and other expenses. For 2022, we expect to see continued pressure on our gross margin. While increased disposable mix should help on a year-over-year basis, we will recognize manufacturing variances related to lower-than-planned volumes, higher component costs, and labor costs, and lower yields on certain products. On our reported basis, the impact of capitalized variances will be more significant in the first half of the year. Over time, strengthening our gross margin is a top priority for us. And improving this metric depends on multiple factors, the most important of which is scale. As we grow the business, our fixed costs will get absorbed across higher volumes. Secondary to scale, is product mix between disposables and capital as we execute our plan to drive higher system utilization. In addition to business-related drivers, we're intensifying our focus on controllable variables, such as manufacturing yields, product line optimization, process improvement, and automation. Our operations team is actively evaluating specific opportunities and we will update you accordingly. We recognized the criticality of improving our gross margin and have included certain goals in our 2022 management incentive program. Non-GAAP operating expenses were approximately $21.4 million in the fourth quarter of 2021 compared with $21.3 million for the same period last year. Higher SG&A related to investments in our commercial organization and higher expenses related to clinical trials were offset by lower R&D expenses tied to the timing of certain development programs. Our non-GAAP operating expenses have been roughly flat on a sequential basis the past six quarters. And we expect our non-GAAP operating expenses to decline starting in Q2 of this year. As we realize the benefits of our restructuring program. Excluding specified items, our non-GAAP net loss for the fourth quarter of 2021 was $28 million or $1 per share compared to a non-GAAP net loss of $24.9 million for the fourth quarter of 2020 or $0.89 per share. Briefly touching on full year results, we had total sales in 2021 of $17.3 million compared with $8.5 million in 2020, driven by 1. increased adoption of our Mapping system and platform; 2. higher capital equipment sales; 3. the launch of our therapy product line outside the U.S.; and 4. left heart access. Non-GAAP operating loss was $101.5 million for the full-year 2021, compared with $73.1 million in the prior-year. The year-over-year change in non-GAAP operating loss was primarily related to 1. investments in our commercial organization; 2. product development, as well as clinical trial and regulatory expenses to support our expanded product portfolio; 3. public company related costs; and 4. manufacturing variances. Excluding specified items, our non-GAAP net loss for the full-year of 2021 was a $107 million or $3.74 per share, compared to a non-GAAP net loss of $83.7 million for the full-year 2020 or $3.91 per share. Our total cash and cash equivalents balance including restricted cash at the end of Q4 2021, was a $108 million. Turning to the outlook. In our press release today, we provided first quarter guidance that calls for revenue of $3.2 million to $3.5 million compared to $3.6 million in the first quarter of 2021. As a reminder, during Q1 2021, we recognized capital sales of approximately $1.2 million. For Q1 2022 however, there is no capital revenue included in our guidance. We're in the very late stages of finalizing a few new installs, which if executed in Q1 would put us towards the high-end of our guidance range. Excluding capital equipment sales, the midpoint of our Q1 2022 guidance implies year-over-year revenue growth of greater than 40%, all driven by disposables. With respect to the full-year 2022, we're encouraged by Mapping, procedure, volume trends year-to-date. The pace at which we have been able to reposition consoles to hire potential sites. Growth in left heart access, and the continued adoption of AcQBlate outside the US. Assuming stable market conditions, we expect to see disposable growth of at least 30% to 35% in 2022 on a year-over-year basis. At the same time, we expect to see lower capital equipment sales in 2022 as compared to last year. Specifically, in 2021, we registered capital sales of approximately $4.1 million excluding rentals. This included a significant number of conversions from prior evaluations to long-term placements. As we re-positioned Console to new sites, we're not forecasting a meaningful contribution from converting these units in 2022, especially given the time required for a physician to thoroughly complete an evaluation and for us to clear administrative processes, When putting these factors together, we expect full-year 2022 sales to be flat to slightly up when compared to the $17.3 million generated in 2021 as growth in disposables is expected to be offset by year-over-year declines in capital equipment sales. As we execute on our restructuring strategic initiatives at 2022 operating plan, we will provide further updates during investor conferences and future earnings calls. We appreciate your continued support and interest, and I will now turn the call back to the operator to facilitate our Q&A session. Operator.
Operator: Thank you. As a reminder, to ask a question, you will need to press star one on your telephone, to withdraw your question press the pound key. Our first question comes from the line of Robbie Marcus with JP Morgan.
Robbie Marcus: Thanks for taking my question. Maybe start. I don't think people are going to be thrilled with the full-year guidance for 22 and recognizing its with fewer people. But It does raise the question of future cash burn versus your existing cash of around a $100 million. And how long that can last for and what your plans are for future capital needs.
David Roman: Thanks, Robbie. I'll start.
Vince Burgess: I mean, Robbie. Thanks for the question. I'll let David speak to the sort of numbers in the -- from the Casper, just some perspective. but I think what we have experienced and learned over the last year, year-and-a-half, is that this market and the physicians that we serve is extremely heterogeneous. We have to be very, very thoughtful, very careful about where we place our systems, how well we segment those customers, how we launch into those centers. And while we have good launch, opening success in Europe, I think, driven not only by our terrific team over there, but the fact that we have an integrated therapy offering. I think that predictability and the ROI on those launches and install base and expansion is more reliable, more predictable. Our team here in the U.S. is exceptional, our clinical and commercial team. But as we launch, we -- through this year until we have an integrated therapy option, we think early next year, we have to be even more selective with where we launch because when we launch into a center where we integrate with typically somebody else's Therapy Cathetering System, we got to be very, very thoughtful about where we go. And that's what's really driving our decision to slow the installed base growth for this year. And that's obviously -- without the installed base growth this year, you don't have some of that capital and conversion revenue that we had anticipated at our -- during our prior earnings call, and the associated disposables. But we think it's the right thing to do for the business to allow us to get out there and have great launch success, prove the program, gain proof points, and build traction where we are. I'll let David speak to the cash implications and feel filler.
David Roman: Sure. Thank you, Vince. So Robbie, on the guidance, I just want to make sure that it's clear the drivers of the revenue outlook here. So, we do expect to see significant growth in disposables this year, which we are seeing year-to-date, driven both by procedure volumes, as well as continued uptake of some of our recently launched products like AcQBlate outside the U.S. and our left-heart access product line predominantly in the U.S. The primary factor influencing year-over-year growth is what Vince has referenced, is the capital equipment sales, which last year were about $4 million, including significant number of sales to Biotronik, as they built out their installed base. And last year, as you know, is the first full year, during which that partnership was implemented. So those are the primary moving factors reflected in the revenue outlook. As it relates to cash, as you point out, we had $108 million at the end of last year. Our restructuring contemplates, if you look at last year, our cash burn was roughly $28 million on average across the four quarters, and that number coming down into the mid-to-high teens, as we exit this year. But we should start to see that benefit reflected in Q2. It is a very fluid environment. Our base case outlook with respect to our cash puts us into the second quarter of 2023, although we have identified some very specific levers that can further extend our position. And we'll be ready to respond rapidly as needed.
Robbie Marcus: Thanks. And maybe within the accounts that do use the Mapping system, what procedures are you seeing them use it for? And what percentage of their total cases do you think they're being used in as we think about maybe broadening it out in the future?
Vince Burgess: Let's think about the market for a second. The EP business -- the top line of EP business globally, it's -- we believe it is north of $6 billion of top-line. The procedures that are done today, we believe are 35% to 40% complex procedures. This is persistent, long-standing, persistent AFIB, a typical flutter complex Tachycardia. Again, 30%-35%, that's so -- the segment that that implies -- the size of the current segment that implies is somewhere between $2-$3 billion. This is our power out. This is where physicians -- in front of physicians all the time. I always hear, when I ask physicians, what are your pain points? What are your problems? They always come back to those complex procedures where there is no standardization procedural approach globally, period, none. Every physician has somewhat to dramatically different approach. When you ask about what is coming down the pipeline from competitors large and small to help with that, you generally get -- you almost always get blank stares. Nobody -- there's just nothing coming that we can see in that are physicians will look us in the eye and say, well, there's this coming from this multinational or this from the startup to help address these issues. We think we've got a very compelling offering in this space. So that's our segment, so redo ablations and they are believe me, plenty of those, reduced to re-dos, complex Tachycardias, atypical flutters typically, and atrial tech cardias following, for instance, cryoablation are very, very common. All centers see them regularly. And that's really our sweet spot where we have the greatest array of differentiation in our current product line.
Robbie Marcus: And Vince, any way to tell what percentage of the cases are being done today at the, I believe, at the 18 centers that have your systems?
Vince Burgess: Yeah, I think these numbers are a little hard to get at because of the characterization and how they segment and report out. But we think where we are, we're in that maybe 7% zip code in terms of the share of the cases we get. There are some centers where we get -- I think we get well over 25% share. There are other centers where new and they're just getting going with this and we're we're obviously not there yet. We've got some bellwether centers where we're getting I think the base very significant share of those complex procedures.
David Roman: And, Robbie, just to clarify, the 18 centers that Vince referenced on the call, that's where we had our Ablation System installed. The market share number of that 7% to 8%, that's across our entire install base, including the U.S where we obviously don't have an Ablation Catheter. In Europe, where we do have an Ablation Catheter and we have an established user, we have market share of complex cases well into the double digits.
Robbie Marcus: Great. Thanks a lot.
Operator: Thank you. And our next question comes from the line of Amit Hazan, with Goldman Sachs.
Phil Murphy: Hi. This is Phil on for Amit. Thanks for taking my question. I thought I wanted to start with a kind of clarifying question about the guidance and about the quarter. You'd previously broken out Biotronik as a component of the revenue. I was hoping you could do that for 4Q. And then talk about Biotronik as a component of the sales guidance that you just provided so we can better understand how the underlying business might be performing within that.
David Roman: Sure. So thanks for the question. In our -- the reason we have are now disclosing our sales U.S -- in OUS is by -- the strategy around Biotronik is to give us accelerated global reach. And for us to build our portfolio and build out the value proposition that we offer into markets that has significant case volumes, but where it doesn't make sense for us to invest organically today. And very similar to other larger medical device companies who have distributors outside the U.S.. We just happen to have one very large one who serves as our global partner. And they are -- the volumes that they do are reflected in the procedure volume disclosure that we provided today. So as we look forward, we're going to be including Biotronik in our global business. So, the trends at Biotronik fees are very reflective of the underlying trends that we experienced globally. I will say that, as you might recall in the third quarter of last year, Biotronik purchased a significant number of new consoles to seed their existing accounts and to grow their install base. We did not see the same level of capital equipment purchases from them in the fourth quarter is really a disposable driven quarter. And we would expect disposables for all parts -- all operating segments of our business really to be the primary driver of growth, both here in Q1 and for the balance of 2022.
Phil Murphy: Okay. Thanks, David, maybe I could ask it slightly differently. And try to characterize the outlook for U.S. versus OUS sales next year, if you're willing to provide a commentary on the impact of the sales force cuts in the commentary around capital sales in the U.S. until we have a blade of technique that we can couple with the system.
David Roman: Sure, Phil. We expect growth both in -- let's talk about dispo -- let's break out disposables and capital separately, because in the U.S., we expect growth in disposables. We expect growth in disposables outside the United States also. With respect to capital equipment, you will probably see a bigger decline outside the U.S. reflecting the Biotronik impact from last year. Of the $4 million in capital that we sold last year, I think almost half of that went to Biotronik over the course of last year, so we would obviously -- we would not expect that to recur. On a geographic basis, globally expect procedure volumes to grow as well as disposables. And then -- and capital equipment declined globally, but mostly led by the markets outside the U.S., including Biotronik.
Phil Murphy: Okay. That's helpful, David. Thanks so much. Also, in the press release -- if I could ask just one more, please. In the press release, you mentioned continued strategic review. I'm just wondering, with pretty substantial restructuring already having been announced, if you could potentially frame some of the pathways that that strategic review could potentially result in moving forward to, obviously, what the implications are for longer-term growth trajectory.
David Roman: Thanks so much for the questions.
Vince Burgess: I'll take this out a bit and David, if you want to chime in as well. If you look historically at the company, we have invested heavily in building out highly differentiated portfolio, not just but for one better mouse trap, one focused product just in Mapping for instance. We invested very heavily by way of organic development acquisition, in licensing, etc., across the full spectrum of EP. So we've created a small company, but with a broad product line and the product across EP, Mapping and Ablation therapy. We've also invested heavily in development and training of a crack commercial and clinical support team, including a sizable, one of the larger direct sales and commercial organizations in the US and Western Europe. And of course, we've invested very heavily in supporting our partner Biotronik. We think there are multiple opportunities to explore non - dilutive financing, possible distribution opportunities of other companies’ products through this channel, at our own channel, etc, that are levers that we can pull. We've been approached on a number of things. We've approached ourselves on a number of possible opportunities, and we are exploring those very actively. As you look at this space, EP is one of the most dynamic spaces in all of Med Tech, and there are a lot of folks that want to be in this business. There are a lot of folks that have products that are earlier stage in this business that don't have any sort of distribution themselves. And we're we're looking at the full array of possible opportunities here.
Operator: Thank you. And our next question comes from the line of Margaret Kaczor with William Blair.
Brandon Lower: Hi, everyone, this is Brandon on for Margaret. First is, if we can focus a little bit on the first quarter, since we got kind of a preliminary range there and where basically through the quarter now is curious, maybe you have a little more flexibility to talk about what are some of the highlights in the quarter? What's going well for you guys as we move through Q1, specifically? And then where the areas for improvement that you guys are focused on through the rest the year.
David Roman: Sure. I can start on that and Vince can add some additional perspective on how our strategy is unfolding here. So the first quarter as, as I said, really it's going to be entirely driven by disposable sales. We, given our focus to isolate our commercial organizations to really driving procedure volumes within the accounts that we are currently serving. We will not like -- we're likely not to execute any capital conversions in the first quarter. We did see a significant bolus of capital sales in the first quarter of last year. So we did about $2.3 million in disposable sales last year in the first quarter. And if you look at the midpoint of the guidance range that we've provided here of $3.2 to $3.5 million, that implies 40 - ish -- a little over 40% growth on a year-over-year basis. One of the things that we've been monitoring very carefully as we execute this strategy of repositioning consoles is the extent to which that may or may not be disruptive to procedure volume growth. And we are pretty encouraged with what we're seeing year-to-date that on a global basis our procedure volumes are up year-over-year. We are not seeing many external related headwinds, obviously, COVID-19 continues to be something that we monitor, but we are pretty pleased with what we're seeing executing procedure volumes as well as an increase in utilization, particularly in the U.S. in Q1 when compared to Q4 of last year.
Vince Burgess: Yeah, coming into the quarter, announcing a restructuring and also repositioning a meaningful number of the consoles, that dislocation requires you pulling out and then reinstall console at a new center and retrain -- and train up the staff, the learning curve issues and all that, those two factors combined obviously gave us a little bit of a pause. And then you throw in omnicron, which I think has hit procedure volumes across MedTech in a lot of instances. With all three of those things, we're actually quite happy with our procedure volumes in Q1 in spite of all of those three sort of challenges, if you will. So quite pleased with the team, quite pleased with what's going on there.
Brandon Lower: Got it. And then as you look at the field today, we're talking about some of these maybe unproductive systems getting cold and going into more productive accounts. Can you maybe just compare and contrast some of the accounts that are doing well today. What's different about those? Why are they underperform -- or why are they performing compared to those non-performing and how confident are you that it just needs a little more focus and you can replicate that successful strategy through’22? Thanks.
Vince Burgess: Yeah. There's a whole array of factors that can contribute to rapid or not so rapid uptake in utilization and certain consoles just not being productive. And it goes from our key champions literally moving from one account to another, so that we don't have that champion there, or to a different state. And we've had that happen a number of times. We also -- I think we've learned -- and we talked about this on prior calls, we've learned about the process of segmentation. And we've got asked the right questions about how physicians feel about their workload, their setup, the types of accessories they want to use, and the types of procedures they want to use our Mapping System on, and what therapy catheter, particularly in the U.S., they're most comfortable with. Our system works quite well with some other folks’ therapy catheters. If -- and we do well there, it doesn't work or doesn't work as well with other therapy catheters. And if we go into a center with -- where the key physician really wants to use Catheter A, which isn't -- doesn't integrate as well with our system, sometimes we just don't -- we don't have a overall great customer experience, and that provides a challenge. And if we do -- as we do a better job, and we're learning to do this, do a better job at qualifying our customers where we're going now, we're seeing better outcomes, we're seeing better launch profiles.
Operator: Thank you. And next question comes from the line of Marie Thibault, with BTIG.
Marie Thibault: Hi. Thank you for taking the questions. One assets first one here on the restructuring and just sort of confirm the timelines. Is the restruction complete at this point? How many sales reps do you have here now in the U.S.? In what geographies are they focused on? And what are you hearing from sort of your customers in the field in terms of their awareness or thoughts on the restructuring, how it impacts them?
Vince Burgess: Restructuring was announced in early January, the 60-day warn Act period. The team members that are no longer with us were let go. I think the 2nd week of March, 2nd-3rd week of March, as part of that, obviously, not a great thing to do because we got -- not a fun thing to do it because we got incredible team here. I would say by and large, this is a team commercially and otherwise company-wide the top mission is a very passionate group of people. I think every single one of the people that was part of the reduction regretted that, did not want to leave. They very much wanted to stay here because they believe in what we're doing and they'd rather work here than elsewhere. So that was -- if I would say by and large, the people that remain, you go through these things, Marie and I think it toughen people up and you get kind of a bunker foxhole kind of mentality and we lock arms and we fight, and we fight forward. And I think we're doing a good job with the team building and building esprit de corps going forward. I will tell you there are certain situations where we've had a couple of situations where we had a clinical support specialists that was highly favored by one physician over another and a couple of those folks were part of the restructuring and we've had to take extra efforts and make extra efforts to transition someone new into the organization. They're not in to service that particular customer, and sometimes those things take a little bit of time, but I think the team's doing a great job getting that done.
Marie Thibault: Understood. And I agree that that's a tough thing to go through. Did you say how many sales reps you have left and what geographies you're able to cover still in the U.S.?
Vince Burgess: I don't know that we're actually for competitive reasons, focusing exact -- we're not going to talk about our exact numbers, but our key pods, where we really had good success and we got a good concentration of customers, consoles, and clinical support people and sales folks are in the south west of the U.S., the south east and the north east corridor in the U.S. And then the UK and Central Europe continues to be a real strong area for us.
Marie Thibault: Okay. And perhaps as my follow-up, you could offer a bit more detail on the PFA-CE mark trial timeline. I heard you say you expect enrollment and follow-up this year. How quickly could we see some of that happen? And has there been any impact to the U.S. trial enrollment timelines given some of the restructuring efforts? Thanks for taking the question.
Vince Burgess: Start the U.S. trial enrollment timelines of Flutter trial. The therapy trial in the U.S., it's an IDE trial, we should certainly be completed with enrollment within the next quarter, I think it's fair to say early in the next quarter. So that's been going well. When you hear about a lot of trials being slowed by COVID and whatnot, I think our clinical has team done a great job continuing the momentum there. From a PFA perspective, we do expect to complete enrollment on the PFA-CE project we're working on this year and follow-up. We're not talking with a lot of granularity around our expected date of Ce Mark and FDA trial. We are still in -- we're still analyzing that. The timelines and the clinical trial design as it relates PFA in the U.S. with our focal point ablation catheter.
Marie Thibault: Thank you.
Operator: Thank you. And our next question comes from the line of Bill Plovanic, with Canaccord Genuity.
Bill Plovanic: Great. Thanks. Good evening. And thanks for taking my questions. Firstly, I just like start out with the restructuring, considering it's completed at this point. Would you consider it completed? What was your head count as you exited 2021? And where is your headcount globally as you end the restructuring? And then how is that U.S versus OUS, if you could give us any granularity on that? That'd be great. Thanks. That's first question.
Vince Burgess: David, you want to take that?
David Roman: You'll see some of these numbers reflected in our 10-K filing. So at the end of December, we had 338 people globally in the company. And our restructuring involved 59 people who are notified in January and who exited the company in mid-March. I would also point out, and perhaps not unexpectedly on top of that, we've had some additional voluntary resignations over that time period in backfield. Some other critical roles. So I would use that so of 60 - ish number as the reduction in headcount where we'll be entering the second quarter. The vast majority of the reduction was in the U.S..
Bill Plovanic: Okay. That's good. And then as we think about that, you talked about the strategic shift to the pods, as you look at the U.S. and you start shifting around and going to that core pod strategy, how much do the current core pods generate in the U.S.? Is it an 80 or 20, 90, 10, where in terms of 20%, accounts are generating 80% or 90% of revenue? And then you're moving up a lot of the other systems around? And the other half of that question is this is something you started, I believe, last year when you hired the new commercial person. And are we at the end of that transition? Beginning of that? Where we in moving those systems around?
Vince Burgess: I would say as we exit this quarter, I think we have moved the systems we -- based on our analysis, we feel like we wanted to move. I think we've moved the lion's share those by now. I think the most part, they placed them into new accounts. In terms of the percentage of revenues that come from the we'll just -- we'll call on the regions where we've decided are constant -- to concentrate our efforts and our people. I'd say the lion share of the revenues historically came from those regions and paths. We had people and few installs and other areas. But there was not a lot of -- we didn't -- we had difficulty ramping in those regions where we didn't have consistent clinical support there at the ready.
Bill Plovanic: All right. Okay. So it's probably fair to say, or at least to believe that the Q4 is a good base upon which to work off in terms of your core U.S. position and the international business on a procedural disposables standpoint; is that pretty fair?
David Roman: I think that's a good representation of it. The only -- the one -- the only thing I would add to Vince’s commentary is, as we re-position consoles, we are obviously looking to do that within these established commercial regions. So as we re-expand our install base, we're looking to align those consoles with areas where we have an established sales force, well-trained therapy managers and the right level of support so we can supp -- so we can drive increased procedure volumes on an increased install base without significant investment -- incremental investment and headcount.
Bill Plovanic: Got you. And then -- so that's the commercial. On the R&D strategy, I think there wasn't any discussion of the atrial fibrillations trial that was expected to enroll in the third quarter. Is it fair to say that that's probably TBD going forward and that's not on the table, one of the projects that hit the chopping block, or how should we think about that?
Vince Burgess: Well, as you look at the therapy landscape, the -- it is generally accepted that Pulsed Field Ablation is coming hard and coming fast, and point likely to replace standard RF ablation over time. And as you know, Bill, these -- the AFIB trials typically take two-and-a-half years to three years to complete, do -- enroll 12-month follow and then nine months, 12 months in from the FDA. So we have held that trial and not yet started enrollment while we assess and watch what's happening with PFA. If you can imagine, it's -- with a three-year trial and with heavy expense, it's very tempting and I think probably advisable for us to be thinking about transitioning a trial like that to a PFA therapy or platform.
Bill Plovanic: Understood. Yeah, that makes sense. So, as you mentioned, the right atrial flutter, seems to be -- if that's approval, early ’23 is a little faster than we expected. And then as you mentioned, you'll follow-up the PFA strategically and push that through given the timeline. Okay. That is all the questions I had. Thank you very much.
Operator: Thank you. And our next question comes from the line of Javier Fonseca with Spartan Capital.
Javier Fonseca: And thanks for taking my call. Considering the significant cost claim announced early in the year, can management shed some light on the commercial buildup for the expected U.S. mark entry for AcQBlate? And by then, do you think the focus would be to ship it back to increasing system installments? Thanks.
Vince Burgess: I think that's a good assumption that. Because we -- as we get--as we gain approval in the U.S. all signs in Europe point to a better customer experience or efficient sales and launch process on an account by account basis when you have fully integrated Mapping and therapy in the software. Because with it. So I think I think that's a pretty logical way to think about it.
David Roman: And I think Javier on the commercial infrastructure to your question to support the AcQBlate launch in the U.S., we launched AcQBlate in Europe with our established commercial team. It was a very important and seamless add into their bag. And I think the bigger question for us will be if AcQBlate drives the acceleration in procedure volumes that we had seen in Europe, will we have to invest in additional clinical and therapy Manager support? But in terms of the existing sales infrastructure, we think given the quality of the organization we have in the U.S., the extent of experience in EP, and depth of relationships that are current team holds that they are very well equipped to launch AcQBlate successfully, as was the case in Europe.
Javier Fonseca: Awesome. Thanks. one more question.
Operator: Thank you. This concludes today's conference call. Thank you for participating and you may now disconnect.
