U.S. Markets close in 1 hr 42 mins
  • S&P 500

    3,631.83
    +54.24 (+1.52%)
     
  • Dow 30

    30,012.32
    +421.05 (+1.42%)
     
  • Nasdaq

    12,029.49
    +148.86 (+1.25%)
     
  • Russell 2000

    1,852.01
    +33.72 (+1.85%)
     
  • Crude Oil

    44.79
    +1.73 (+4.02%)
     
  • Gold

    1,802.90
    -34.90 (-1.90%)
     
  • Silver

    23.23
    -0.40 (-1.71%)
     
  • EUR/USD

    1.1882
    +0.0037 (+0.3089%)
     
  • 10-Yr Bond

    0.8750
    +0.0180 (+2.10%)
     
  • Vix

    21.76
    -0.90 (-3.97%)
     
  • GBP/USD

    1.3360
    +0.0038 (+0.2832%)
     
  • USD/JPY

    104.5430
    +0.0550 (+0.0526%)
     
  • BTC-USD

    19,194.32
    +742.36 (+4.02%)
     
  • CMC Crypto 200

    380.93
    +11.18 (+3.02%)
     
  • FTSE 100

    6,432.17
    +98.33 (+1.55%)
     
  • Nikkei 225

    26,165.59
    +638.22 (+2.50%)
     

Edited Transcript of AFIB.OQ earnings conference call or presentation 12-Nov-20 10:00pm GMT

·49 min read

Q3 2020 Acutus Medical Inc Earnings Call Nov 13, 2020 (Thomson StreetEvents) -- Edited Transcript of Acutus Medical Inc earnings conference call or presentation Thursday, November 12, 2020 at 10:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Gary W. Doherty Acutus Medical, Inc. - CFO * Vincent J. Burgess Acutus Medical, Inc. - President, CEO & Director ================================================================================ Conference Call Participants ================================================================================ * Bradley Thomas Bowers BofA Merrill Lynch, Research Division - Research Analyst * Malgorzata Maria Kaczor William Blair & Company L.L.C., Research Division - Research Analyst * Marie Yoko Thibault BTIG, LLC, Research Division - Director & Digital Health Analyst * Robert Justin Marcus JPMorgan Chase & Co, Research Division - Analyst * William John Plovanic Canaccord Genuity Corp., Research Division - Analyst * Caroline V. Corner Westwicke Partners, LLC - MD ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Ladies and gentlemen, thank you for standing by, and welcome to the Acutus Medical, Inc. Third Quarter 2020 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I would now like to hand the conference over to your speaker today, Caroline Corner, Investor Relations. Thank you. Please go ahead, ma'am. -------------------------------------------------------------------------------- Caroline V. Corner, Westwicke Partners, LLC - MD [2] -------------------------------------------------------------------------------- Thank you, operator. Welcome to Acutus' Third Quarter 2020 Earnings Call. Joining me on today's call are Vince Burgess, President and Chief Executive Officer; and Gary Doherty, 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 fact 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 the SEC, including the risk factors described in Acutus' Form S-1 and in Acutus' quarterly report on Form 10-Q for the third quarter ended September 30, 2020. 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 for the third quarter 2020 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 p.m. Pacific Time today. Now I'd like to turn the call over to Vince for his comments on third quarter 2020 business highlights. -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Caroline, and thank you, everybody, for joining us today. While it has only been about 2 months since we updated you with our second quarter 2020 performance, following our initial public offering in August of this year, our team has been hard at work installing consoles, driving adoption of our products with key customers and pressing forward on further expansion of our product lines through aggressive and accelerated R&D efforts. Before we get into our quarterly results, however, I'd like to share a couple of quick stories to remind you of why we do what we do here at Acutus and why our company's mission to improve the way cardiac arrhythmias are diagnosed and treated is so important to us and to patients and to the physicians in the electrophysiology community. As an illustration of how our technology is successfully helping patients and clinicians alike, let me review 2 recent case summaries. Patient #1 is a 29-year old male whose heart at a young age had been surgically altered to bypass his right ventricle. The patient subsequently developed significant atrial tachycardias, extremely rapid heartbeats that would cause him to collapse. Catheter ablation was attempted using one of our competitor's systems in late 2019, but was eventually abandoned because the conventional mapping system that was used was unable to handle the 8-plus different atrial tachycardias that were presenting in this one patient. Sadly, the patient's arrhythmia has persisted. And due to the pandemic, the U.K. hospital where he was initially treated was under a complete lockdown. The electrophysiologist felt strongly that the Acutus system and its SuperMap algorithm would be able to effectively map the patient's multiple complex tachycardias, giving hope for a successful outcome. She appealed to the hospital and received special dispensation from the hospital's senior leadership team to perform a repeat procedure using the AcQMap system. During the procedure, 10 different atrial tachycardias were identified and ablated, successfully restoring sinus rhythm in this young patient. Patient #2 is a 42-year old male with long-standing persistent atrial fibrillation who had already undergone 2 prior ablations. Due to further recurrence of atrial fibrillation, he was scheduled for a third ablation, this time to be guided by the AcQMap system. The electrophysiologist used the map, ablate, remap strategy made possible by the speed and ease of use inherent to the AcQMap system throughout the procedure. The patient left in sinus rhythm at the end of the procedure and continues to do well with no recurrence of symptoms. The electrophysiologist, being both a social media enthusiast and author of a recently published patient education book on living with AF, was so excited about what he could see in the maps that he posted them on Twitter, Instagram and LinkedIn. His post generated over 2,500 views and multiple comments and questions, presenting him the opportunity to further explain and share information with the EP community. Quoted from his LinkedIn post, "For one of the first times we can visually display one of the most chaotic heart rhythms atrial fibrillation and existence. Using a technology called high-resolution noncontact mapping, we are one step closer to solving the puzzle of this cardiac chaos." Now that I've reminded you a bit about what we do, I would now like to turn to our third quarter performance and highlight some key successes. In the quarter, we saw strong execution by our commercial team and made considerable progress on key product development and operational fronts. Our revenues of $3.2 million were up 391% year-over-year and up 180% sequentially. Despite headwinds from COVID-19, we continued to add new customers and aggressively upgrade existing customers to our groundbreaking second-generation electrophysiology mapping system. Bringing on a new customer in our business requires extensive cross-functional collaboration with our customers and many members of our internal team. The installed base growth that we achieved this quarter demonstrates enthusiastic demand for our technology and terrific execution from our entire team during uniquely challenging times. With each new install, we are optimizing our account opening approach and improving our physician and lab staff engagement. As we better appreciate the opportunity to grow our base and improve utilization across a large and expanding product line, we are pulling forward investments in our commercial organization and accelerating work on several important product development initiatives. Our value proposition across a range of clinical scenarios is increasingly clear, and our highly targeted product line expansion projects are progressing with great speed. As we look to the future, we're highly confident that Acutus is well positioned for growth in the years ahead. During the quarter, we increased our worldwide installed base of second-generation AcQMap consoles to 37 as of September 30, 2020, up from 21 consoles at the end of the prior quarter. The combination of new installs and upgrades from our first-generation consoles brought the total global installed base of consoles to 49 as of September 30, 2020. Console placement activity was robust during the third quarter, and we expect it to remain strong overall in the fourth quarter. Placement activity in Europe is becoming more complex as COVID-related travel restrictions are enacted, and we have our eyes on that. As always, we strive to take advantage of our nimbleness and creativity during times of great change, and we are planning our first fully remote console installation during the fourth quarter. This will require considerable investments in remote training resources for third-party installation personnel in Europe and, soon, in Australia. As for the U.S., pandemic-related logistics challenges are currently rare and placements are presently continuing at a rate in line with our internal expectations. Moving now to case volumes. We saw July and August EP lab activity comparable to what we observed in June, although we did see some normal seasonal impacts due to European summer vacations, which we would also expect in future years. September was a record month for us in terms of procedural activity overall and the release of our commercial-grade conventional contact mapping software suite during the third quarter shows early signs of this mapping modality becoming a significant portion of our expanding procedural volume going forward. The inclusion of conventional contact mapping capabilities gives customers a reason to use our system in even the simplest of cases and is allowing us to leverage our existing mapper presence in lab to cover multiple cases in a day and garner more case share in labs. This increased exposure to our overall platform provides an excellent opportunity to grow revenue and makes efficient use of our mapper resources. Illustratively, a major southern California hospital is now routinely scheduling days with 3 or 4 cases with us, including conventional contact mapping and noncontact mapping, knowing we have unique capability to cover cases calling for both as we continue to move forward and become a true workhorse platform across all atrial arrhythmias. Additionally, we are also starting to see use of our mapping system in cryoballoon cases and in ablation cases that are done entirely without the use of x-ray-based fluoroscopy, an emerging trend with EP physicians who are seeking reduced radiation exposure to their patients and for themselves. As the third quarter began, we saw most EP labs back open at or near full capacity as COVID cases slowed. We were readily able to access hospitals in the U.S. and in most of Europe, though a portion of the hospitals in the U.K. were slower to reopen. With the recently observed rise in COVID cases throughout Europe, there are signs of regional slowing in the market. Of particular note, France, the Netherlands and Belgium appear to be curtailing elective procedures to some degree, and the U.K. is slowing on a regional basis. The prevailing current view is that we will not see full lockdowns and lab shutdowns as we experienced in March, though, in the markets we just discussed, there will likely be a slowing of case volume over the next several weeks. We are making every effort to work around the obstacles that continue to be presented by the pandemic in real time, but wanted to make you aware of their existence and potential challenges we may encounter. As a further example of the benefits of the breadth of our product line, our Transseptal Access products are being very well received not only in EP ablation procedures, but also in structural heart applications given certain workflow and safety benefits. We believe our commercial team expansion will facilitate traction in this space, both in accounts where we have already an AcQMap console installed and in those accounts that do not yet have an AcQMap console. In fact, through our customer outreach and sales efforts around the Transseptal Access products into EP and structural heart labs, we are capturing clinician attention for our AcQMap console. We've seen some recent synergy here as a pair of Transseptal Access sales calls have resulted in hospitals in Arizona and Southern California accelerating their efforts to bring in an AcQMap console. We continue to be pleased by our ability to attract and train highly qualified clinical specialists and commercial leaders to the team. At the end of September, we had 24 fully certified and 9 provisionally certified mappers worldwide. This is up from the 19 fully certified and 8 provisionally certified mappers we had on June 30. Given the success of our initial public offering during the third quarter and the account development opportunities we are seeing across our large and expanding product line, we are accelerating the build of our sales force. During the quarter, we added top-tier sales and sales management talent with great track records and long-standing industry experience. As another update on our commercial front, our bidirectional distribution agreement with Biotronik, a large privately held cardiology company that focuses primarily on cardiac rhythm management, continues to gather momentum. This agreement gives Acutus the ability to leverage Biotronik's global sales distribution infrastructure and helps us more rapidly achieve truly global reach. During the quarter, we completed the handover of existing Acutus accounts in Germany and Switzerland to Biotronik as Biotronik will be our exclusive distributor in these and 20 other countries. We executed on an extensive remote sales, mapper and technician training plan in the quarter, focusing first on countries where Biotronik will have regulatory approval for the system. In addition to the CE Mark Acutus had already obtained, Biotronik received regulatory clearance in Australia for our mapping system and related accessory products and was granted special access approval in Malaysia. Biotronik and Acutus are actively working in concert on regulatory approvals in other countries. We continue to be very pleased with our relationship with Biotronik and are encouraged to see strong engagement from local teams as we rely heavily on distance learning for our hardware, software, catheters and related case knowledge. On the product development front, in addition to releasing our commercial-grade contact mapping software suite, we have made major progress on building out the scope of our left heart access product lines and on the development of our post-field ablation technology. The energy and pace of innovation here at Acutus is really impressive. As an example of the scale of our efforts, we have conducted 37 preclinical labs since July 1, each testing one or multiple new products, features or elements of our full product portfolio, be it pulsed field ablation, conventional RF ablation, septal crossing, conventional contact and noncontact mapping and the like. Moving on now to clinical and regulatory updates. In the third quarter of 2020, we received a key U.S. clearance on our AcQMap catheter 2.0. This is an important product evolution on our core noncontact mapping catheter as it combines a meaningful production cost reduction with enhanced capabilities, including handling advantages and faster acquisition times. Our limited market release of the catheter has begun and initial feedback is positive. Our clinical and regulatory teams have also been diligently working through the process to initiate 3 separate IDE studies for our therapy catheter lines. For the U.S. market, we plan to submit 2 separate trials for our AcQBlate gold-tipped irrigated radiofrequency force sensing ablation catheters. Both are now expected to commence in the first half of 2021. As you may have seen with other medical technology companies, we have seen regional systemic challenges related to sterilization of medical devices with ethylene oxide, largely driven by local contract sterilizer community environmental concerns. As sterilization vendors cope with these issues, as exacerbated by the pandemic, completion of validations for new products, such as ours, attempting to commence IDE trials can be challenging. As a result, we are currently expecting our IDE trial start dates to be pushed out roughly 1 quarter as compared to previous time lines. The first of our trials, which is seeking a right atrial flutter indication, is expected to take about 2 years to complete and obtain a premarket approval or PMA. Based on current time lines, we expect that indication to be approved and commercially available in late 2022 or early 2023. Second is seeking a paroxysmal and persistent atrial fibrillation indication in the U.S. market and will likely take approximately 3 years to complete and obtain premarket approval, which means we currently expect to enter the U.S. market potentially in late 2023 or early 2024. The third U.S. trial involves our partnership with Biotronik and relates to Acutus private labeled versions of a series of Biotronik-sourced and CE Mark platinum-iridium and gold-tipped ablation catheters, which should take approximately 2.5 years to complete, which means we expect to receive premarket approval around the first half of 2023 in the U.S. markets. Looking ahead, we anticipate receiving CE mark on our AcQBlate force sensing ablation catheter within the coming weeks. This will be an important milestone for the company. And we are looking forward to bringing this novel gold-tipped, irrigated radiofrequency force sensing ablation catheter and related accessories to CE-governed markets. Turning to the bigger picture and our longer-term growth strategy, I would like to remind you of the main revenue drivers for our business. A major focus today on the commercial side is to grow our installed base of AcQMap consoles. Growing in our -- growth -- sorry, growth in our installed base is foundational to our revenue expansion plans over time. It is the razor of our -- for our portfolio of razorblades. We are also focused on driving increased utilization of the consoles. This includes both the number of procedures and the types of procedures performed by clinicians using our system. Increased utilization feeds into our third growth driver, expanding the range of Acutus-supplied disposable products used per case. This includes various mapping, therapy, access, septal crossing and diagnostic catheters. Finally, before I turn things over to Gary, I hope you saw our press release today regarding the hiring of Dr. Steve Mickelson as our new Vice President and Chief Translational Science Officer. Steve is a practicing electrophysiologist and a prolific technologist and inventor. Notably, he was a founder and former CEO of Farapulse, a pioneer in the highly promising field of pulsed field ablation. He is a recognized thought leader in the field with an extensive clinical background, and we are thrilled to have him as part of the Acutus team. We continue to be very excited about the possibilities and opportunities for our pulsed field ablation program and look forward to updating you on our progress on future calls. With that, I'll now turn it over to Gary for our financial results. Gary? -------------------------------------------------------------------------------- Gary W. Doherty, Acutus Medical, Inc. - CFO [4] -------------------------------------------------------------------------------- Thank you, Vince, and good afternoon, everyone. Our revenues for the third quarter of 2020 were $3.2 million compared to $1.1 million for the second quarter of 2020 and up $2.5 million from $0.6 million for the same period of the prior year. The 180% increase in revenues from the second quarter of 2020 to the third quarter of 2020 was driven by console sales, increased direct sales of Acutus disposables and distributor sales to Biotronik. The 391% revenue increase observed for the third quarter of 2020 relative to the same period of the prior year was driven by the expansion of our installed base following our full commercial launch, which began at the end of 2019 as well as the implementation of the Biotronik agreement. Gross margin was negative 62% for the third quarter of 2020 compared with negative 251% in the third quarter of 2019 and negative 135% for the second quarter of 2020. In advance of, and following our full commercial launch, we have made significant investments in our manufacturing infrastructure to support future capacity requirements and position us to scale production as our business grows. As volumes increase, we expect to see the benefit of these investments and improvements to our margin profile. Gross margin during the third quarter of 2020 was positively impacted by greater production volume and comparatively greater efficiency in our manufacturing operation versus the third quarter of 2019. Headwinds from COVID-19 modestly impacted production levels during the second quarter of 2020, while production during the third quarter of 2020 returned to more normalized levels. At this point, I would like to take a moment to provide some additional color on our revenue recognition model for our consoles that are placed with customers and then paid for with disposable commitment deals. Most of you are familiar with this model, which is common in certain parts of health care, but for those that aren't, these contracts are structured so that the console is placed free of charge at the customer site and then title to the console passes to the customer after a negotiated and contractually binding amount of disposables are purchased over the life of a multiyear contract. For these kind of sales, which we expect to be very common at Acutus going forward, we recognize a portion of that future disposable revenue stream and 100% of the cost of goods sold for the console upfront while locking in a predictable high-margin disposable revenue stream over time. The way the accounting plays out, this results in unfavorable gross margins on the upfront sale of the console that is more than offset in future quarters by a committed, predictable annuity stream of disposable sales over the life of the contract. For the quarter, it is important to note that margins on our line of disposables were positive. We successfully converted several installed systems to disposable commitment deals. And as just explained, recognized a portion of the revenue on each deal, along with 100% of the cost of goods sold for each console in this quarter, negatively impacting overall margin performance, this despite underlying positive margins for our disposables. Operating expenses were $24.3 million for the third quarter of 2020 compared with $29.5 million for the same period of the prior year. R&D expense was $8.3 million in the third quarter compared with $20.9 million for the same period of 2019, which included a $15 million payment for the Biotronik force sensing product line. Excluding the Biotronik payment, our increase in organic R&D expense primarily related to spending on catheter developments and console enhancement projects during the third quarter of 2020. SG&A expense was $15.8 million in the third quarter of 2020 compared with $8 million for the same period last year. The increase was primarily due to $5.4 million in noncash stock-based compensation expense. As was mentioned during our Q2 earnings call, this amount includes a onetime noncash $3.8 million amount related to the achievement of performance conditions for restricted stock awards, which were met upon our IPO. Also impacting spend was the expansion of our commercial team in conjunction with our full launch and an increase in G&A for public company-related costs. Commencing this quarter, we present our net loss on a GAAP basis and on a non-GAAP basis to exclude items that we believe are not representative of our core operating results. Net loss on a GAAP basis for the third quarter of 2020 was $31.3 million or $1.95 a share compared with a net loss of $32.1 million or $47.21 per share for the same period of the prior year. Results for the third quarter of 2020 included $6.4 million of noncash stock compensation expense, a final $3.7 million fair value remeasurement of our warrant liability and a $0.1 million charge for the -- in the -- sorry, change in the fair value of contingent consideration. Excluding such noncash items, our non-GAAP net loss for the third quarter of 2020 was $21.1 million or $0.91 per share compared to $30.6 million for the third quarter of 2019 or $1.86 per share after giving effect to the pro forma conversion of our convertible preferred stock. It is important to note our warrants are no longer subject to remeasurements upon their conversion to common stock warrants in connection with our IPO. Weighted average basic and diluted shares for the third quarter of 2020 was 16.1 million compared to 0.7 million for the same period of the prior year and pro forma shares of 23.3 million for the third quarter of 2020 compared to 16.4 million, assuming the conversion of our preferred stock for the same period of the prior year. For a complete reconciliation of our GAAP financial measures to our non-GAAP financial measures, please refer to the tables included with the press release that we issued today. Our total cash balance at the end of the third quarter of 2020 was $167 million. As a reminder, our August 5 initial public offering yielded $166.3 million in net proceeds, and we believe the resulting cash on hand is sufficient to fund our current operating plans. We also wish to advise that given the uncertainty from the ongoing COVID-19 pandemic, we are not in a position to give forward guidance at this time. We will update you when we have greater clarity around forecasting through the pandemic. With that, I'll now turn it back over to Vince for closing remarks. Vince? -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [5] -------------------------------------------------------------------------------- Thank you, Gary. In closing, I would like to acknowledge and thank the investor community that has taken an interest in our story here at Acutus. To do so requires an investment in getting up to speed on the electrophysiology market we serve; the significant opportunity that exists here to improve outcomes, efficiency and cost effectiveness in this segment of cardiology; and on the differentiation and benefits provided by the innovative tools and techniques that we are bringing to the electrophysiology community as a whole. I've never been more excited about a med tech company than I am about Acutus. The excitement comes from the fact that we are bringing new and highly novel tools to a field that needs them in order to attack long-standing riddles that remain unsolved. By challenging the current conventional wisdom in this space and collaborating with the best, most creative minds in electrophysiology, we are confident that we can and will bring much-needed improvements in patient care and build a large, profitable and highly valuable company in the process. We are excited by the future and pleased to now have the resources from our public offering, completed just 3 months ago, to fuel our plans. With that, I would like to thank you for your attention, and I'll now turn the call over to the operator for your questions. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Our first question comes from the line of Robbie Marcus from JPMorgan. -------------------------------------------------------------------------------- Robert Justin Marcus, JPMorgan Chase & Co, Research Division - Analyst [2] -------------------------------------------------------------------------------- Vince, I was hoping you could start out. I'd love to hear how the discussions have been going coming out of the third quarter here. You've now had about 1.5 months. We've seen a worrying change in the COVID situation, particularly in Europe and growing in the U.S. So I just wanted -- you said during the script, you still see a lot of enthusiasm for purchases in the fourth quarter. Has the conversation changed at all in relationship to purchasing units in the near to midterm, in your view here? -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Yes. Thanks, Robbie, I hope you're well. I'd say no. In terms of purchasing or negotiating contracts for catheter-based commitments, on balance, I don't think we've seen any change there. We're really happy with the installed base we've put in place in the last quarter. And I have to tell you, I'm really proud of my team for making that happen to -- if you think about it, to get significant teams of people on airplanes and ship consoles and whatnot across the country or around the world, have in-service meetings with large group of nurses and doctors in the context of a COVID environment that we live in, I think, speaks volumes about how interested folks are, how serious folks are about bringing this technology into their hospitals and their level of commitment and our team's level of commitment. I would say, there, I can think of one console deal in Europe that where we felt like it was very much going to be a fourth quarter placement. And they notified us a couple of weeks ago, it felt like there was probably going to be a January install instead. This was at an Italian site. But conversely, we've actually had a couple come in or we expect to come in a little earlier than expected. So from a placement standpoint, installed base standpoint, we feel good. Of course, subject to change. But we're not really having access problems to get our field service teams and do the installs and doing the in-servicing. The comments in the prepared remarks were more focused around procedure volumes that are happening in EP labs, and there -- we're watching that really carefully. It's so regional. I would say a significant number of the hospitals that we're regularly in touch with in the U.S., they're kind of at their normal census right now in terms of their procedure volume. Others are looking a little wobbly. And then Europe, we're certainly still doing cases over there in Central Europe, including in some countries where, at a public level, they've announced dramatic slowdowns in elective cases, and yet we're still doing cases. So these are uncharted waters. We're watching very closely what's going on. -------------------------------------------------------------------------------- Robert Justin Marcus, JPMorgan Chase & Co, Research Division - Analyst [4] -------------------------------------------------------------------------------- Great. I appreciate the color. And Gary, I know you haven't given guidance for the year, but the Street is sitting a little under $6 million for fourth quarter. Are you comfortable with that number here? And do you think we need to make any more material changes to gross margin in the model going forward as you think about some of the unit placements here on contract versus catheter profits in the near term? Just trying to get the models straight in the near to midterm here. -------------------------------------------------------------------------------- Gary W. Doherty, Acutus Medical, Inc. - CFO [5] -------------------------------------------------------------------------------- Good to talk to you, Robbie. We -- there might be, in terms of the top line, a benefit to employing a measure of conservatism a little bit around some European impacts for case delays and case postponements. From a margin perspective, our plans are such that we're going to see all this sort of unfold the way we'd originally laid it out to you. We have a number of cost reduction programs that are going to be coming online over the course of the next several quarters. Volume will be our friend. And you kind of put it all together in a bucket and you should be reasonably comfortable with the pacing that we've laid out before. -------------------------------------------------------------------------------- Robert Justin Marcus, JPMorgan Chase & Co, Research Division - Analyst [6] -------------------------------------------------------------------------------- Got it. And if I could sneak one last one in here. During -- I can't remember if it was during late second quarter or early third quarter, you guys put out a press release on your electroporation catheter and made it official. This is a really exciting opportunity down the road. It could keep you right in the forefront, not just with the mapping, but with the ablation itself. I was hoping you could speak to this catheter, where you stand versus the competition, your expectations for the market to evolve. -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [7] -------------------------------------------------------------------------------- Yes. Sure. So this is an area that we feel and I think all participants in this field believe has just great promise to significantly speed procedure times and improve the safety profile of these procedures. It remains to be seen if electroporation will change efficacy in any material way. Speed and safety matters, so we're all over it. And you saw in the press release, I think we -- that we issued alongside our earnings release today with the hiring of Steve Mickelson. Steve is really one of the forefathers of pulsed field ablation. He was a founder of Farapulse, a real high-profile company in this space. And we've actually been working very closely with Steve for the last year on a consulting basis. And he's so enamored with this company and our approach to innovation and the speed with which we innovate that he's decided to come on board full time with this company, and he is moving from his home in Iowa to San Diego. So we have a very talented, focused team developing the hardware, software, the pulsed designs and the catheter set to be right in the mix with the others that are working in pulsed field ablation today. We are not giving precise time lines or product strategies at the moment as we announced in our prior release. Our plan is to come out of the gate initially, having pulsed field ablation right on the back of our force sensing gold-tipped ablation catheter. So we think that is a nicely differentiated strategy as compared to what some other folks are doing. And we obviously will have other products -- other catheter products in that portfolio as well. But we're just extremely excited and very, very happy with the progress that we've made, thus far. We will be reporting on time lines in future calls and in future press releases, but we're not getting into a lot of detail as we sit here. -------------------------------------------------------------------------------- Operator [8] -------------------------------------------------------------------------------- Our next question comes from the line of Bob Hopkins from Bank of America. -------------------------------------------------------------------------------- Bradley Thomas Bowers, BofA Merrill Lynch, Research Division - Research Analyst [9] -------------------------------------------------------------------------------- You actually have Brad Bowers on for Bob today. I was just wondering what additional color you could give on procedures or kind of procedure per console was in the quarter, if there was anything nuanced about the pace of that over the quarter. Or where that kind of fell in respect to your expectations. -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [10] -------------------------------------------------------------------------------- Gary, do you want to take that? Or do you want me to take that? -------------------------------------------------------------------------------- Gary W. Doherty, Acutus Medical, Inc. - CFO [11] -------------------------------------------------------------------------------- I got it. Generally speaking, the pace of procedural activity was in the ballpark of what we were looking at from an internal expectation point of view we've seen across all geographies. In particular, I would point out that the Biotronik range of accounts they took over during the third quarter performed particularly well on a kind of per box basis. We're seeing a lot of uptake, as we've mentioned in the script, with them, and that's continuing. -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [12] -------------------------------------------------------------------------------- I would say these are early days for us and as we are building our expertise and rolling out new accounts. We have -- what I'm really excited about is the release of our contact mapping software suite. So this is -- I think this is a software and mapping suite that goes toe-to-toe with the existing competitors in their space with their conventional contact mapping. What it has the potential to open up for us is situations like we have referenced in the prepared remarks, where as opposed to trying to get 1 complex case a week initially and then 2 and then 3 over time, this opens up the opportunity, for example, in this hospital in Orange County, where we're having 3 and 4 cases scheduled in a day. That may include some cases that maybe aren't as complex and high revenue as a complex, long term or persistent AFib case, but it allows us to utilize and leverage the mapper that we have in there to get us involved in less complicated SVT cases and the like. And that's just not procedure volume and revenue that we'd spend a lot of time mapping and modeling to in, say, a year ago when we were kind of sketching out what this business and what the launch looks like, because we just -- we didn't have a great handle on the release date of that contact mapping suite and on the completeness of launch. So that's a really, really exciting new element of this complete product portfolio for us. -------------------------------------------------------------------------------- Bradley Thomas Bowers, BofA Merrill Lynch, Research Division - Research Analyst [13] -------------------------------------------------------------------------------- Got you. That's helpful. And then if I could have one follow-up there. Just -- I was just kind of wondering how you think about the installs that you're doing kind of given -- on the new model where you kind of just give it into the hospital. How do you think that can accelerate your procedural uptick per console, whether or not you're thinking that's going to like accelerate that or just increase it on the base overall? And then that's all for me. -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [14] -------------------------------------------------------------------------------- Yes. For us, it's all about having successful installs and engaging with -- engaging deeply with the initial physician, who is the champion that gets us in there in the first place, and try and grab as much of that physician's procedural volume case share as we can. And then trickling down or going down the bench, if you will, or across the bench to other physicians and EPs within the lab. And that we are -- like I said, we're early days here, but we are definitely executing on that strategy. And I feel great about how that's going to roll out over time. -------------------------------------------------------------------------------- Operator [15] -------------------------------------------------------------------------------- Our next question comes from the line of Margaret Kaczor from William Blair. -------------------------------------------------------------------------------- Malgorzata Maria Kaczor, William Blair & Company L.L.C., Research Division - Research Analyst [16] -------------------------------------------------------------------------------- First of all, I wanted to maybe touch a little bit on some of your intro comments, Vince. You talked about maybe seeing both demand on the contact and on contact mapping tech. I think you mentioned cryoballoons as well and seeing some uptake there. So can you give us any color in terms of how consistently that's happening? Outside of that one example, maybe add what can that mean for you, are you surprised, I guess, by that uptake? -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [17] -------------------------------------------------------------------------------- It's early days. We just launched our contact mapping suite, I think, in the second or third week of September and are rolling that out into multiple accounts and rolling it out to different physicians as we speak. So early indications are that, I think, that's going to give us a nice foothold into some of these more simplistic cases. I'm sorry, if you could ask the -- restate the second part of the question. -------------------------------------------------------------------------------- Malgorzata Maria Kaczor, William Blair & Company L.L.C., Research Division - Research Analyst [18] -------------------------------------------------------------------------------- Just that why -- what that could mean for you guys, were you assuming very much there? Because obviously, train wrecks as well as some of the more simplistic cases, but a fair amount of the market, so theoretically should be a good thing for you. -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [19] -------------------------------------------------------------------------------- Yes. I think it's just important for us to be a part of the fabric of the lab and not be the technology or the product that they roll in for the train wreck cases that just need the highly, highly sophisticated system. When -- and I've lived this in a prior life in Volcano when we really just got off the ground there, we were pigeonholed into studying imaging around left main coronary artery disease cases, which is 5% of the patient population. And atrophy and the muscle memory sets in around how to use the system if you're only using it once every couple of weeks. In order to be really successful here, we want to be used regularly during the week. Obviously, we think we're going to be used in some of those complex cases and redos with great regularity. But we want the staff, we want the physician, we want our mapper to be using our system regularly. So they understand the cableology, the troubleshooting, the setup, the graphical user interface, the interface with our catheters and the like. So in order for us to really take full advantage of this opportunity here, we think the business is going to be healthier. It's going to be more sustainable, and it's going to be more profitable as we grab more and more of those procedures and involvement there. Even if the revenues in some of those procedures are lower just because they just tend to use less disposables and less -- lower ASP disposables in some of those cases, that's just -- that's revenue and opportunity that we didn't spend a lot of time modeling in our prior model. -------------------------------------------------------------------------------- Malgorzata Maria Kaczor, William Blair & Company L.L.C., Research Division - Research Analyst [20] -------------------------------------------------------------------------------- Okay. Can you work that into some of these new kind of utilization-focused contracts as well, to get both sides? -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [21] -------------------------------------------------------------------------------- Absolutely. That's a great comment. And if you think about it, if you're trying to spread the cost of a console, including the gross profit we want to make over the multiple years of these arrangements, the ability to -- and this makes the customer feel better as well. Instead of saying to the customer, "Okay, you've got to use x basket catheters a quarter for y months." We can say, "You have to use x dollars worth of product per quarter over y months, spread across the entire catalog of Acutus products." So that can be the basket catheter, that can be the electrode patches, that can be the left heart access products, ultimately, the therapeutic catheters and the like. So it's just -- it lowers the threshold, lowers the barrier for the customer as they think about signing a contract like that. -------------------------------------------------------------------------------- Malgorzata Maria Kaczor, William Blair & Company L.L.C., Research Division - Research Analyst [22] -------------------------------------------------------------------------------- Okay. And if I could squeeze one in, just on the model quickly. Just -- I appreciate the commentary on COVID and I appreciate the commentary on some of the international, maybe, slowdown that you guys can't control. But does that impact at all the installed base towards the end of 2020? And more importantly, as we think about 2021, does that change kind of the disposable utilization or the ramp process that maybe you were assuming previously? -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [23] -------------------------------------------------------------------------------- So I think you asked 3 questions there. Does it impact the installed base? Presently, we don't believe it's going to impact materially the ramp of the installed base, present day. Obviously, it's an ever-changing world every single day. But that's how it feels to us right now. And I was on the phone with our Head of Europe this morning, just kind of checking in one last time. And so that -- we do feel good about that. The utilization per console, absolutely, it is -- there -- in Europe, for example, we -- one country has come down pretty hard on elective procedures. We only have 1 console in that country, so that may not be as material. We're watching daily, trying to understand the impact on procedure volumes across all of EP and how it affects us specifically. Some of the factors here, they're not necessarily obvious that affect us, right? It's -- on the one hand, you have patients and families that may or may not want to get anywhere near a hospital when there's a lot of COVID patients there. You have situations where anesthesiologists are hard to find, and particularly in the United Kingdom in some hospitals, because they're busy taking care of COVID patients. And that affects the ability to do general anesthesia, EP, ablation cases. On the other hand, we -- there was -- there were a lot of patients with arrhythmias that were not being treated in the spring and summer. And this is -- these are not clinical situations as a patient you want to tolerate indefinitely. So -- and a lot of these folks are just itching to get in and get themselves treated. So that's going to be some of the positives. We can't delay this indefinitely. And our physicians, many of our physicians don't want to delay the ablations. They don't -- they want to do their work, and they want to get in there. And the other thing to think about here is the industry, the hospitals and we have all adapted over the last 4 to 6 months. So whereas in March and April of last year, we had fairly sparse dispersion of mappers in Europe and in the U.S. And so it was difficult to get people traveling around, going to cases, getting on airplanes and all that during that time. We have much better coverage now, both in the U.S. and in Europe. And the hospitals have developed tactics and strategies to get people in and out of the hospital without having to do an overnight stay. So everybody is kind of working together to figure out how to keep this industry growing. And on balance, I feel good about that. -------------------------------------------------------------------------------- Operator [24] -------------------------------------------------------------------------------- Our next question comes from the line of Bill Plovanic from Canaccord Genuity. -------------------------------------------------------------------------------- William John Plovanic, Canaccord Genuity Corp., Research Division - Analyst [25] -------------------------------------------------------------------------------- Can you hear me okay? -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [26] -------------------------------------------------------------------------------- Yes. -------------------------------------------------------------------------------- William John Plovanic, Canaccord Genuity Corp., Research Division - Analyst [27] -------------------------------------------------------------------------------- So a couple of questions. Gary, just -- I'm sorry, Vince, as you launch a new product, right, you're always learning new information upon which to kind of refine that launch strategy and better hone it and make it more efficient and productive, and you mentioned that a bit. I was wondering just what specifically or anything you've learned in these early days that you're doing to improve that efficiency and getting those accounts up and operational as you're rolling them in? -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [28] -------------------------------------------------------------------------------- Yes. Great question. I'll be honest with you, after we got the IPO done, I put on -- I grabbed my suitcase and went into the field. So I've spent, I don't know, maybe 1/3 of the last quarter, maybe 40% of the last quarter on airplanes, in greens, footlet on, next -- standing shoulder-to-shoulder with my mappers and our commercial team to get at exactly that question. And I think -- and so with, obviously, some of my other colleagues in management, and as an aside, we were told multiple times that senior management from -- exactly no other EP companies were doing anything like that. So we were -- as we always are, we're out front and center and kind of leading the charge here. I think one of my biggest takeaways, Bill, was as we roll into an account, if you think about it, we have the opportunity and the obligation to train on a whole bunch of different things when we do a launch. We're not just training on a mapping software, user interface. We're training on the cableology and the console and all of that. And we train on the modifications we suggest in terms of procedure when you use our system, and we train on catheter management and troubleshooting. And for 1 person to do that, as you roll into an account in the first, let's say, 4 to 6 weeks while they're running the mapping system, it's hard to keep an eye on what's going on with the physician as they're manipulating the catheter when you're running the mapping system and looking at these incredibly complicated electrograms and whatnot. One of the key learnings I took away from that was, when we launch, we want to have multiple bodies in the account, so that we've got somebody over the shoulder of the doc, talking to the doc, talking to the nurse, talking to techs, making sure they're manipulating catheters properly, emphasizing some of the key points and learnings on the screen that we bring out, that maybe the competitors don't, while that mapper is running the mapping system. So as you're doing that bring up of these accounts, I think we're going to want to come in a little heavier with that initial product introduction phase and that team. So that's one of the reasons. And I referenced it in the prepared remarks that we have made the decision to pull forward some additional hires as compared to what our plan was so that we could make sure that we could properly staff those early cases. Now do we need to have that kind of body count indefinitely in these cases? No, absolutely not. Once they sequence the doc and the staff have figured out the cables and the catheter management and everything else, we believe that our basic commercial structure remains unchanged over the medium and long term. But in those early days, we're going to come in heavier with our staff than we have probably mapped out. -------------------------------------------------------------------------------- William John Plovanic, Canaccord Genuity Corp., Research Division - Analyst [29] -------------------------------------------------------------------------------- Okay. No, that's -- yes, that's understandable when you're bringing a differentiated technology in. And then just this one was for Gary. As we think about -- I don't know if I missed it, but did you give us a ballpark on the mix of capital versus disposable in the quarter and/or geographic mix? -------------------------------------------------------------------------------- Gary W. Doherty, Acutus Medical, Inc. - CFO [30] -------------------------------------------------------------------------------- It's all in the Q. But for capital, it was roughly 31% of the total. And U.S. revenue was about 59% of the total, relative to the U.S. -------------------------------------------------------------------------------- William John Plovanic, Canaccord Genuity Corp., Research Division - Analyst [31] -------------------------------------------------------------------------------- And then the last question, just -- and it's been asked a little. But as we think of the accounts that you're targeting to bring online, and I think you had a pretty deep pipeline of those that you have. Has that -- have there been any significant changes to kind of those targets over the next couple of years, over the last couple of months or lifting, lowering, bringing in new, what have you? Any just qualitative would be helpful on kind of that pipeline because I think that's the real key here, is getting the accounts on and getting them productive to drive the disposables. So I think to me that's the key, at least. -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [32] -------------------------------------------------------------------------------- Yes. I would say punchline would be no. No material changes to how we're thinking about that. The one sort of new wrinkle for us is if you think about it, there are 700 EP labs in the country and those are all targets for us. In addition, now that we have the septal access, left heart access product line that really, I'll tell you, our conversion rates on demo for that product line are phenomenal. And they're using these products in not just in ablation cases, but in WATCHMAN cases and MitraClip cases and like any time they want to get across that septum to do a procedure. There are -- there's some overlap, there's considerable overlap. But there are accounts out there that don't have a mapping system and aren't on our radar to drop a mapping system in anytime soon that are going to be spinning up and buying regularly those left heart access products. So that's a nice additional revenue driver for us. I will tell you that that product is also, I believe, is going to be a great brand ambassador for us in those accounts because that gets our reps and our folks in front of cardiologists, interventional cardiologists, structural heart people, key people, all of whom are colleagues typically within the same cardiology practice. They all talk. And we've already had a couple of examples where there's great cross-pollination there where somebody wasn't really on our radar yet about getting a mapping system, and they heard about Acutus. They used the product. They saw this as a slick little product. "Oh, never heard of this company before. What do you guys do? Oh, you're mapping system, too. Tell me about that?" And then it's just -- then it cascades and flywheels from there. So I think that's a really interesting opportunity. It's early days. We haven't modeled that out to any great degree, but I think that's something else we'll be talking to you about over time. -------------------------------------------------------------------------------- Operator [33] -------------------------------------------------------------------------------- Our next question comes from the line of Marie Thibault from BTIG. -------------------------------------------------------------------------------- Marie Yoko Thibault, BTIG, LLC, Research Division - Director & Digital Health Analyst [34] -------------------------------------------------------------------------------- I wanted to start here, I guess, with the forthcoming CE Mark you have coming on the AcQBlate force sensing catheter. Can you tell us a little bit about customer anticipation of that over in Europe, and then sort of thoughts on procedure revenue given that milestone? I know that's sort of adding a new product to the procedure in a way. So any thoughts there? -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [35] -------------------------------------------------------------------------------- Yes. We're very excited. We think we're well down the road in getting that CE Mark. You can never sort of celebrate until you actually -- you get the piece of paper, but we feel like that's coming in a very short order. The therapy being -- and this is a big moment for this company to be a -- to become a therapy company in any country where we have a CE Mark. And we'll be going direct in all the countries where -- we're direct over there, and Biotronik will be launching these products in the markets that they have. But it is definitely -- it has the potential to be a game changer for us because, number one, I think it's a great product, and it's not really just -- it's not so much just a catheter. Because when we get approval on the catheter, that allows our mappers and our commercial team to walk in and present the hospital with a complete ablation system. So we already have approval in CE Mark on the related accessories. And what I'm referring to there is our force sensing unit, which is a small electronic box, which measures the force of the typical catheter, and an RF ablation catheter and irrigation pump and a stimulator and a controller that we distribute for Biotronik. This, in my opinion, is the most modern electronic stack in all of EP. It has a great -- it's a small footprint. It is a recently designed and executed set of electronics that are very, very well tied together electronically and from an integration standpoint. And then you plug in this gold-tipped force sensing catheter, which has distinct advantages, we think, over the competition. And it just presents a really great look and product to the customer. So we think that is going to elevate our image in the field. We think that's going to get physicians, nurses, hospital administrators to think about us differently as compared to coming in as a company that has mapping and other accessories to being a true full-service EP company. So just really, really excited to get started there, and we think that's going to drive great revenue. I would point out that we do expect that will drive revenue on the therapy side in hospitals where we have mapping systems and in those cases where they use our mapping system. We also -- because of the design of our system, we also believe we will drive revenues on therapy where we don't have mapping systems or where they have a system, but they happen to not need to use a mapping system like in a simple SVT case. Our competition doesn't necessarily do that or allow for that. And we're really excited about that strategy and launch strategy and that capability. -------------------------------------------------------------------------------- Marie Yoko Thibault, BTIG, LLC, Research Division - Director & Digital Health Analyst [36] -------------------------------------------------------------------------------- That makes sense. And then another question here. During the quarter, we saw some FDA approvals of new catheter therapies for the persistent AF population. What's your thinking on that and how that affects, if at all, the -- how you sell the AcQMap system? My own thoughts on sort of anything that improves the outlook for some of these persistent AF patients is a positive for any player, but I'd love to hear sort of your thoughts on that as well. -------------------------------------------------------------------------------- Vincent J. Burgess, Acutus Medical, Inc. - President, CEO & Director [37] -------------------------------------------------------------------------------- Yes. My read on those approvals, if I'm thinking about the same ones that you're thinking about, is those are approvals for the indication for the use of those ablation catheters in persistent cases where there was no explicit approval for same historically. The basis upon which those approvals were granted, I don't believe was based on any significant or notable increase in outcomes. It was the comparator in those trials and the clinical efficacy threshold, I believe, was 50%. So -- and I believe the outcomes were modestly higher than that. But there were -- to my knowledge, there were no -- in each of those trials, there were no notable stepwise improvements in outcomes in the persistent patients. It was just a -- they were studies that assessed the safety and confirmed the efficacy was no worse than a 50% threshold, if I have that right. -------------------------------------------------------------------------------- Operator [38] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.