Acutus Medical, Inc.

Good day and thank you for standing by. Welcome to the ACUTUS Medical Incorporated Second Quarter 2021 Earnings Conference Call. Access time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today. Caroline Corner, Investor Relations. Please go ahead.

Thank you, Operator. Welcome to ACUDA's second quarter 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 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's Form 8-K filed with the SEC today and are also discussed in more detail under the risk factors section in ACUTUS's most recent filings with the SEC, including the risk factors described in ACUTUS's 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. Acutis undertakes no obligation to update these statements except as required by applicable law. Acutis' press release with second quarter 2021 results is also available on the Acutis website, www.acutismedical.com, under the Investors section, and includes additional details about Acutis' financial results. The Acutis website also has Acutis' SEC filings, which you are encouraged to review. A recording of today's call will be available on the Acutis website by 5 p.m. Pacific time. Now I'd like to turn the call over to Vince for his comments and second quarter 2021 business highlights.

Thank you, Caroline, and good afternoon to everyone joining us today. During today's call, I will provide an update on our key strategic priorities, as well as some recent clinical, commercial, and market developments. I will also comment on our second quarter results and provide some thoughts on external market dynamics. David will follow up, with details on our financial and operational results, as well as our outlook for the rest of the year. Our team remains steadfast in its commitment to reshape the field of electrophysiology. There is nothing more important to us than improving clinical outcomes and changing the treatment paradigm for the patients and healthcare professionals we serve. We recently completed an $83 million capital raise net of fees and expenses And with improved momentum in our business, we are charging forward on all fronts and realizing our strategy to become the partner of choice to electrophysiologists through our broad and differentiated portfolio of access, diagnostic, imaging, and therapy products. We are executing on our commitments, and we are building this company for long-term success. As we look to further bolster our commercial strategy, we are pleased to welcome Niamh Pellegrini to our board of directors. Niamh currently serves as chief commercial officer at Nevro and has over 20 years of experience in the medical device industry. Niamh has held commercial leadership roles at several companies where she has a track record of driving strong growth and consistent performance. We are very excited to benefit from Niamh's guidance as she joins the company's board this month. I also want to thank Shahzad Malik for his extended service as we announced today that he will step down from our board of directors. Shahzad and his team at Advent Life Sciences were among the first to invest in Acutis during our Series A round in 2011. Shahzad has been a trusted advisor and friend over the past decade, and we greatly appreciate his contributions and support. Over the past several months, we have seen ongoing improvements across our three strategic pillars, technology and innovation leadership, commercial execution, and operational excellence. These improvements are reflected in our second quarter financial results, as well as in recent product approvals and clearances R&D program development, and physician engagement. All of these initiatives were clearly on display at the 2021 Heart Rhythm Society meeting that was just wrapped up in Boston in late July. As a reminder, this was the first in-person HRS since 2019, and our first opportunity to be in front of a large group of physicians since our full market launched in February of 2020. In our booth, we showcased our complete and highly differentiated product portfolio, as well as unveiled details of major development programs. We featured our broad offering from access with our AccuCross transeptal line of products to diagnostics and mapping with our AccuMap system to therapy with our AccuBlade force-sensing ablation catheter and system, as well as our pulsed field ablation program. We were thrilled and humbled by the strong attendance at our booth and our relevant scientific sessions, and a large number of walk-in customers eager to learn more about who we are and what we offer. Many of our conversations during the meeting carried a common theme of acknowledgement from the clinical community that ACUTUS is positioned not only as a participant in EP, but poised to be a leader in the field. Our sales team left the meeting with over 150 high potential leads, and we are already capitalizing on these incremental commercial opportunities. Our rhythm theater session at HRS included nine of the industry's most well-known and accomplished EPs. Here, we highlighted the core to boundary individual ablation strategy, that is uniquely enabled by our AccuMap system. In addition, we introduced our development plans for our Pulse Field Ablation, or PFA program, which we believe provides a differentiated paradigm in ablation therapy. We had not previously discussed our PFA program in detail with the broader clinical community, and we were very encouraged by the response from HRS attendees. A full replay of this session is available on our website and YouTube channel. Just to drill a bit deeper here, unlike the vast majority of PFA programs under development, we are using our AccuBlade Force Sensing Ablation Catheter as the therapeutic workhorse delivery device for our PFA program. Physicians will have the opportunity to adopt PFA with a familiar platform as well as have the option to use our catheter for either RF or PFA procedures. In addition, our catheter will enable focal point ablation with PFA, facilitating more targeted delivery of therapy and flexibility to reach any anatomy during treatment. Having a point ablation system will allow us to treat patients suffering from all cardiac arrhythmias including atrial fibrillation and disease in the ventricles and right atrium. Combined with our AccuMap mapping system, our PFA program will have the potential to enable patient-specific ablation therapy, especially among more complex patients. This is a deliberate choice to enable a fast therapy platform on a fast imaging platform, to guide therapy in line with our mission to treat AF with a personalized approach to improve outcomes. In recent months, animal studies have shown increasingly promising results, and we continue to expect first in human for our PFA program later this year, and we'll provide updates accordingly. In addition to PFA, we continue to make progress in our efforts to bring a therapeutic catheter to the U.S., Enrollment in our US IDE trial for right atrial flutter is progressing well, and we continue to expect to complete enrollment toward the end of this year with approval for the catheter and system in late 2022 or early 2023. In May, the FDA approved our IDE application to evaluate the accublate force-sensing ablation catheter and system in both paroxysmal and persistent atrial fibrillation patients. We are in the process of recruiting sites and expect to treat the first patient in this trial during the third quarter. As we continue to advance our clinical development pipeline, we have achieved several important regulatory clearances and approvals that are critical elements of our product portfolio. These include our AccuBlade force sensing ablation catheter and system in Europe, our complete line of AccuCross transeptal devices, and our next generation delivery sheets and access devices. Our transeptal and access product lines are allowing us to increase our revenue for the procedure, enter accounts where we do not currently have an AccuMap system, and generate revenue in both EP and structural heart procedures. Earlier this week, we announced the receipt of CEmark approval and 510 clearance for our AccuMap8 software package. AccuMap8 is a significant update to our mapping software that will continue to set the standard on fast mapping and diagnosis of complex arrhythmias. AccuMap8 will greatly improve physicians' ability to visualize and identify regions of interest for the treatment of complex rhythms, helping our customers further improve patient outcomes through an even more streamlined procedure. We expect this software upgrade to be a key factor supporting increased mapping procedural utilization here in the second half of the year. Over the past year and a half, we have significantly expanded our product portfolios. from about 15 SKUs in January of 2020 to just over 100 SKUs as of the end of July. This equips our commercial teams with the critical foundation of ACUTUS products needed to build scale in EP. We will continue to expand our product offering in the coming months and years with both incremental launches as well as new platforms. Now turning to our results during the second quarter. We generated revenue of $4.7 million compared to $1.1 million in Q2 of 2020 and compared to $3.6 million in Q1 of 2021. Year-over-year growth was driven by higher procedure volumes globally and increased capital equipment revenue, while procedure volumes and disposable revenues accounted for sequential growth in the quarter. We increased the worldwide installed base of second-generation AccuMap consoles to 68 at the end of Q2, up from 57 at the end of Q1, bringing the total installed base of AccuMap consoles to 70 as of June 30, 2021, versus 62 at the end of last quarter. We exited the quarter with a strong funnel and expect to see continued growth in our installed base through the rest of the year. As discussed previously, we continue to focus not only on growing our installed base, but also targeting the right accounts for sustainable utilization. During the second quarter, we saw these efforts take hold with several new customers now performing procedure volumes within the top quartile of utilization. At these same accounts, we saw active reorder rates during both exiting Q2 as well as here early in Q3. Moving to procedures, we registered volume growth on both a year-over-year and sequential basis in our Europe and U.S. direct business. This growth came from both new account openings and associated uptake as well as underlying growth in existing centers. In addition, our expanded product line is driving disposable revenues outside of AccuMap cases, and we expect this to be a key driver on a go-forward basis. In the U.S., we saw general stability in market dynamics during the second quarter with limited restrictions on elective procedure volumes. As you are aware, however, COVID infection rates have been rising across the U.S. This is an extremely fluid situation, And we are actively monitoring hospital and government actions in response to higher COVID cases, COVID-related hospital admissions, and staffing shortages. As any regional COVID restrictions in the U.S. emerge, we are prepared to actively reallocate our field team's resources elsewhere. In the U.K. and Europe, COVID continued to affect our business throughout the second quarter. One of our largest centers in Europe, for example, was shut for nearly two weeks due to a shortage of anesthesiologists and nurses. We continue to see some intermittent COVID-related headwinds in Europe and the UK, but not materially different from what we have seen in the last few months. Through these challenges, our team continued to execute extremely well and drove increased procedural volumes, no account openings, and overall revenue growth. Lastly, our partnership with Biotronic continues to deliver strong results. During the quarter, we were able to fill almost all the back orders for our ablation catheter to support a full launch in Biotronic territories, and we expect to see broader adoption of our products through Biotronic in the coming quarters. Procedure volumes were negatively impacted by hospital closures in Germany, and our ramp in new markets, like Malaysia, has been delayed, both due to COVID. In the face of these external factors, the Biotronic commercial team remains heavily engaged on training and implementation, and we expect this collaboration to be a critical driver over the short, medium, and long term. Overall, I am extremely proud of the progress our teams are making to execute our strategy and bring innovative solutions to this large and growing market. Through the rest of 2021, we expect to have several clinical data regulatory, and product milestones that will further illustrate our long-term value proposition. We look forward to providing those updates throughout the year. With that, I'll now turn it over to David for our financial results. David?