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AtriCure Investor Presentation Creating a World Class Afib Platform November 2020 © 2020 AtriCure, Inc. All rights reserved. Exhibit 99.2
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This presentation contains “forward-looking statements,” which are statements related to future events that by their nature address matters that are uncertain. All forward-looking information is inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause AtriCure’s actual results to be materially different than those expressed in its forward-looking statements, see its Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and available at http://www.sec.gov, which contain risk factors. Forward-looking statements address AtriCure’s expected future business, financial performance, financial condition as well as results of operations, and often contain words such as “intends,” “estimates,” “anticipates,” “hopes,” “projects,” “plans,” “expects,” “seek,” “believes,” "see," “should,” “will,” “would,” “target,” and similar expressions and the negative versions thereof. Such statements are based only upon current expectations of AtriCure. Any forward-looking statement speaks only as of the date made. Reliance should not be placed on forward-looking statements because they involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to differ materially from those expressed or implied. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future. Forward-looking statements are based on AtriCure’s experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond AtriCure’s control. These risks and uncertainties include, but are not limited to: whether CONVERGE will be approved by FDA and any other required regulatory authorities; whether any additional clinical trials will be initiated or required for CONVERGE prior to approval of FDA, or at all; whether AtriCure will be able to successfully implement its commercialization plans for CONVERGE, if approved; whether the market opportunity for CONVERGE is consistent with the Company’s expectations and market research; AtriCure’s ability to execute on the commercial launch of CONVERGE, if and when approved, on the timeline expected, or at all; whether AtriCure will be able to generate its projected net product revenue on the timeline expected, or at all; the effects of the COVID-19 outbreak on AtriCure’s business and results of operations, including the effects of suspension or halting of elective surgeries; other matters that could affect the availability or commercial potential of CONVERGE and AtriCure’s other products and product candidates; competition from new and existing products and procedures in the highly competitive medical device industry; and other important factors, including, AtriCure’s expectations regarding its financial performance and capital requirements, any of which could cause AtriCure's actual results to differ from those contained in the forward-looking statements or otherwise discussed in AtriCure’s reports filed with the SEC. With respect to the forward-looking statements, AtriCure claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. AtriCure undertakes no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law. © 2020 AtriCure, Inc. All rights reserved. Forward Looking Statements
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AtriCure Overview © 2020 AtriCure, Inc. All rights reserved. Large Markets Addressing an underserved and growing patient population Approximately 33 million Atrial Fibrillation patients globally, with majority having advanced forms of the disease1 Multi-billion dollar annual market opportunity Current standard of care for intervention (catheter ablation) does not adequately address this population Strong Portfolio Existing products and solutions driving consistent growth Strong history of double-digit revenue growth, driven by great products, clinical evidence, commitment to education, and societal guideline support Only PMA product for the concomitant surgical treatment of Afib The AtriClip® device is the most widely used Left Atrial Appendage (LAA) device with over 260,000 sold to date Expanding product portfolio from internal development and acquisitions Bright Future Novel therapies supported by growing body of clinical evidence PMA pivotal trials for hybrid approaches for Afib: CONVERGE, aMAZE Launched pain management business to address pain associated with surgery Early in market development process – evolution to minimally invasive therapies will drive growth, diversifying and accelerating in 2022 and beyond
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Afib: a Serious and Costly Problem Atrial Fibrillation (Afib) is an irregular heartbeat (or arrhythmia) that affects more than 33 million people worldwide.1 Approximately 1.2 million Afib diagnoses annually in the US.2 © 2020 AtriCure, Inc. All rights reserved. Afib diagnosis means: Patients with Afib experience: Average annual outpatient hospital visits4 Risk of Stroke5 Greater risk of all cause Mortality7 Higher risk of Heart Failure6 73% 50+ 10+ Higher total annual direct medical costs3 Average annual physician encounters4 5x >5x 46%
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Concomitant Open Procedures (Ablation/LAAM) Type of Afib matters! Afib is a progressive disease Referring Physician: GP, Cardiologist Two Distinct Patient Profiles © 2020 AtriCure, Inc. All rights reserved. STRUCTURAL HEART ISSUE Surgery required – Afib corrected at same time (Valve, CABG) NO STRUCTURAL ISSUE Afib is primary concern Intervention is better choice Medicine is effective Paroxysmal (occasional) Non-Paroxysmal (Persistent/ LS Persistent) GUIDELINES8 Surgical Ablation is RECOMMENDED LAA management is REASONABLE Standalone Hybrid Procedures (Ablation/LAAM) Catheter often first line of treatment
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Significant Global Market Opportunity © 2020 AtriCure, Inc. All rights reserved. Total US market opportunity $3B+ annually International market $2B+ annually International Market Focus Penetration of large markets first Expand product availability Improve market access via reimbursement Continued build of dedicated sales and training expertise US Market Focus Continued build of dedicated sales and training expertise Clinical data supporting multiple label expansions New product development Enhance reimbursement Market opportunity based on internal estimates and research, as well as from publicly available information. See Supplemental Information for additional detail
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~$350M Pain Management Procedures (Ablation) $2B+ and growing Standalone Hybrid Procedures (Ablation/LAAM) $700-800M Concomitant Open Procedures (Ablation/LAAM) US Market Opportunity © 2020 AtriCure, Inc. All rights reserved. Medicine is effective Steady Growth in penetration of Cardiac Surgery Market Estimated 300,000 total patients (Afib, non-Afib) annually with structural heart issue Only PMA product for the concomitant surgical treatment of Afib Boosting growth via adjacent new market Estimated 140,000 thoracic patients annually Expansive Growth from development of Standalone Afib Market Vastly underpenetrated market with 10-15% estimated annual market expansion Addressable market is more than 3 million patients; less than 1% treated today 25,000 long-standing persistent patients treated by catheter ablation only today Multiple approaches to treatment CONVERGENT + AtriClip, DEEP, LARIAT® Market opportunity based on internal estimates and research, as well as from publicly available information. See Supplemental Information for additional detail
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History of Strong Financial Performance 5-year CAGR > 15% growth 71.6% Gross Margin 71.6% 73.0% 72.2% 73.8% © 2020 AtriCure, Inc. All rights reserved. Revenue Growth Consistent Revenue Growth Strong history of double-digit YoY growth Steady Improvement to Gross Margin $250M Cash & Investments at September 30, 2020 14.5% 15.4% 12.6% 19.5% 20.8%
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Innovative and Expanding Product Portfolio © 2020 AtriCure, Inc. All rights reserved. Ablation 2000 to 2015: Foundation in surgical Afib tools Future pipeline expansion across franchises Appendage Management 2015 and Beyond: Building the future in minimally invasive therapies Innovation toward less invasive, simpler, and more efficient products EPI-SENSE® DEVICE ATRICLIP PRO•V® DEVICE ATRICLIP FLEX•V® DEVICE LARIAT® DEVICE cryoICE® CRYOABLATION PROBE ISOLATOR® SYNERGY™ CLAMP ATRICLIP® FLEX DEVICE ATRICLIP PRO® DEVICE cryoSPHERE® CRYOABLATION PROBE Future Product Launch: ISOLATOR SYNERGY ENCOMPASS™ CLAMP
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CONVERGE Overview PRIMARY ENDPOINTS Effectiveness Primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3 month blanking period through the 12 months post procedure follow-up visit Safety Predetermined performance goal for the study is 12% freedom from MAE’s as adjudicated by the CEC for the procedural to 30-day post procedure time period STUDY DESIGN Summary Multi-center, prospective, open label randomized 2:1 (Hybrid Convergent procedure vs endocardial catheter ablation) pivotal study Number of Subjects and Sites 153 subjects 27 sites (25 US and 2 OUS) Study Duration 12 month and 18 month monitoring, then 3 and 5 year follow-up of all subjects SUPERIORITY TRIAL designed to support FDA approval of the EPi-Sense device © 2020 AtriCure, Inc. All rights reserved. Completed enrollment August 2018 Last PMA module submitted late 2019 Data released at virtual Heart Rhythm Society conference May 2020 PMA submission seeking approval for treatment of long-standing persistent Afib Q4 2020 Achieved statistical superiority for primary endpoints HIGHLIGHTS
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Only multicenter, randomized controlled clinical trial (RCT) comparing the effectiveness of combined epicardial and endocardial ablation to endocardial catheter ablation alone for advanced Afib Demonstrates that the Hybrid Convergent procedure has a compelling safety profile and superior effectiveness when compared to endocardial catheter ablation alone for treatment of advanced Afib Provides high-quality evidence supporting the addition of an epicardial posterior wall ablation to pulmonary vein isolation Emphasizes the value of a team-based approach where collaboration between the electrophysiologists and cardiac surgeons helps achieve improved outcomes for patients with advanced Afib CONVERGE Trial Conclusions © 2020 AtriCure, Inc. All rights reserved.
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aMAZE Overview © 2020 AtriCure, Inc. All rights reserved. SUPERIORITY TRIAL designed to evaluate safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage for the treatment of persistent or longstanding persistent Afib Acquired SentreHEART® August 2019 Trial enrollment completed December 2019 Final Patient follow-up expected 1H 2021 Expect final submission to FDA in 2H 2021 Expect PMA in late 2022 HIGHLIGHTS STUDY DESIGN Summary Multi-center, prospective, open label randomized 2:1 Control Arm – PVI Treatment Arm – PVI + Ligation of LAA with Lariat System Number of Subjects and Sites 600 subjects; 65 sites, all U.S. Study Duration 12 month monitoring and then 5 year follow-up of all subjects PRIMARY ENDPOINTS Effectiveness - Freedom from episodes of Afib >30 seconds at 12 months post index pulmonary vein isolation Safety - Primary safety endpoint for the study is 10% freedom from MAE’s as adjudicated by the CEC for the period from the procedure through 30 days Time Frame: 12 months following pulmonary vein isolation catheter ablation procedure, measured by 24-hour Holter monitoring
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Growth Drivers Q1 2019 launch of cryoSPHERE probe Dedicated commercial team ~$350M U.S. market opportunity* Continuing to gather data to support evidence development of the therapy Potential to contribute to combatting the opioid epidemic – 1 in 7 thoracic surgery patients become reliant upon opioids after their procedure9 SPOTLIGHT: Cryo Nerve Block for Pain Management © 2020 AtriCure, Inc. All rights reserved. Therapy Overview Long-lasting pain management therapy, designed for use in thoracic surgical procedures Temporarily stops the transmission of pain signals coming from the chest wall during surgery Nerve “scaffolds” remain intact allowing axons to regenerate and restore nerve function over time Applicability in a wide variety of thoracic surgical approaches (thoracotomy, video-assisted, robotic) and procedures (resection, transplant, thoracoabdominal, surgical rib fixation, pectus repair) * Market opportunity based on internal estimates and research, as well as from publicly available information.
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Expecting An Exciting Future… Core double-digit growth business with accelerators in EP landscape (Hybrid Convergent + aMAZE) © 2020 AtriCure, Inc. All rights reserved. AtriCure Pillars Foundation of our past and strengthening our future Innovation Expanding pipeline to drive Open ablation penetration and build MIS market Clinical Science CONVERGE & aMAZE trials are complimentary and differentiated as the ONLY RCT for advanced Afib Education Significant investment in physician education, providing multiple training options Aligning Expertise with Opportunity Commercial Teams 54 U.S. Sales Managers Covering 1,000+ accounts 64 U.S. Clinical Specialists providing case support 30 U.S. Dedicated MIS+Lariat team members 14 U.S. Specialists Cryo Nerve Block Team 32 U.S. Education Support Physician + Field 39 International Sales and Clinical Support 2021 Anticipated approval for CONVERGE PMA 2022 CONVERGE contribution, anticipated approval for aMAZE PMA 2023 LARIAT contribution 2024 Full complement of therapies available for differentiated population of Afib patients
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Thank You! © 2020 AtriCure, Inc. All rights reserved.
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Supplemental Information Note that citations/references for any comments, statistics, or figures in this presentation are available upon request. © 2020 AtriCure, Inc. All rights reserved.
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COVID-19 Response © 2020 AtriCure, Inc. All rights reserved. Operationally, financially, and strategically positioning AtriCure for long-term growth Delayed certain capital investments Temporarily reduced executive and board compensation Limited other non-essential operating expenses where possible Maintaining manufacturing, assembly, fulfillment – modified to adhere to safety recommendations Continuing case coverage support Utilizing online and mobile training venues to educate our customers Enabling employees to work from home as appropriate Providing personal protection and other measures to ensure the safety of those working in our offices Limiting non-essential travel Provide a safe work environment for our employees Deliver products and support to our customers Cost-reductions without sacrificing strategic initiatives Health & Safety Maintaining Operations Expense Management While our plans will continue to evolve in response to changes caused by the COVID-19 pandemic, we remain committed to the AtriCure Team and to the execution of our strategic initiatives.
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US annual cardiac surgery volume steady over the past 5 years with shifts in procedure types10 Pre-Op Afib occurs frequently in cardiac surgery patients11 New onset Post-Op Afib is a well-documented complication of cardiac surgery, even if patients do not present with pre-op Afib12 US Concomitant Market Opportunity © 2020 AtriCure, Inc. All rights reserved. Estimated Afib Opportunity in Cardiac Surgery Annual Cardiac Surgeries13 300,000 Pre-Operative Afib Rate11 ~28% Cardiac Opportunity – Pre-Op Afib 85,000 ASP Mix (Ablation and Appendage Management)14 $4,500 Open Cardiac Surgery Opportunity – Afib $382M Estimated Non-Afib Opportunity in Cardiac Surgery Annual Cardiac Surgeries 300,000 Pre-Operative Non-Afib Rate ~72% Cardiac Opportunity – Pre-Op Afib 215,000 ASP Mix (Appendage Management ONLY)14 $1,750 Open Cardiac Surgery Opportunity – Non-Afib $376M
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US Standalone Market Opportunity © 2020 AtriCure, Inc. All rights reserved. Market opportunity in analysis at left considers: Addition of ablation and LAAM to existing catheter ablation procedures Catheter ablation procedures have grown 10-15% annually16 Incremental penetration of advanced Afib patient population Today, long-standing persistent Afib population represents more than 3 million patients in the United States, expected to grow to more than 4.4 million by 202515 ASP Mix reflects both ablation and AtriClip, with potential future uplift from Lariat Estimated Standalone Afib Opportunity 2020 Projected 2025 Long-standing Persistent Afib Catheter Ablation17 25,000 45,000 ASP Mix (Ablation + Appendage Management)14 $15,000 $15,000 Immediate Standalone Afib Opportunity $375M $675M Additional penetration Long-standing Persistent Afib patients (estimated at 5% penetration) 150,000 175,000 ASP Mix (Ablation + Appendage Management)14 $15,000 $15,000 Incremental Standalone Afib Opportunity (estimated at 5% penetration) $2B+ $3B+
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The CONVERGENT Approach © 2020 AtriCure, Inc. All rights reserved.
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4 The LARIAT Procedure © 2020 AtriCure, Inc. All rights reserved. Procedure pics? Access: Routine percutaneous techniques for pericardial and transseptal access are performed using fluoroscopy and transesophageal echocardiography. Delivery: Two magnet-tipped guidewires (FindrWIRZ®) are attached to stabilize the LAA with minimal trauma and manipulation for delivery of the LARIAT. Delivery: The LARIAT snare is delivered over the epicardial FindrWIRZ to the apex of the LAA. Capture: The LARIAT snare is positioned to the base of the LAA using the EndoCATH® balloon for anatomic land marking of the optimal closure site. Closure: The LARIAT snare is closed and the FindrWIRZ and the EndoCATH are removed prior to release and tightening of the suture. Removal: The suture is released and tightened at the base of the LAA and the LARIAT is removed. The SureCUT® suture cutter is used to remotely cut the excess suture. 1 2 3 5 6
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The Cox-Maze IV Procedure © 2020 AtriCure, Inc. All rights reserved.
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Endnotes: © 2020 AtriCure, Inc. All rights reserved. Note Reference 1 Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study 2 The American Journal of Cardiology (2013), 112: 1142-1147 3 Kim MH et al., “Estimation of Total Incremental Health Care Costs in Patients with AF in the US,” Circulation: Cardiovascular Quality and Outcomes, 4 (2011):313-320 4 AF Stat, Avalere, “Health Services Utilization and Medical Costs Among Medicare Atrial Fibrillation Patients,” (2010) 5 J Geriatr Cardiol. 2016 Oct; 13(10): 880–882, doi: 10.11909/j.issn.1671-5411.2016.10.004 6 Santhanakrishnan R et al., “AF Begets Heart Failure and Vice Versa,” Circulation, 133 (2016):484-492 7 Odutayo, A. et al. (2016). Atrial fibrillation and risks of cardiovascular disease, renal disease, and deaths systematic review and meta analysis. BMJ 2016; 354:i4482 8 The Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation 9 The Society of Thoracic Surgeons, Current News Release (1/30/2018): 1 in 7 Lung Surgery Patients at Risk for Opioid Dependence 10 STS Adult Cardiac Surgery Database, 2018/2019 Harvest Executive Summary 11 McCarthy, P.M. et al. (2019). Prevalence of atrial fibrillation before cardiac surgery and factors associated with concomitant ablation. J Thorac Cardiovasc Surg, PII: S0022-5223(19)31361-3, DOI: 10.1016/J.JTCVS.2019.06.062. 12 Lin et al, Stroke 2019 Jun; 50(6):1364-1371. doi: 10.1161/STROKEAHA.118.023921. Epub 2019 May 2. 13 Harvested from data previously available through the Society of Thoracic Surgeons 14 Average Selling Prices (ASPs) are management estimates based on a mix of products used for the various procedures Note Reference 15 Medical management estimate: Colilia, et al. Estimates of Current and Future Incidence and Prevalence of Atrial Fibrillation in the U.S. Adult Population. Am Journal of Cardiology 2013, 112: 1142-1147 Persistent patient estimate: Berisso et al Epidemiology of atrial fibrillation: European perspective Clin Epidemiol. 2014; 6: 213–220 16 Estimated based on various catheter company presentations 17 Estimated based on Advisory Board data, along with various scientific presentations Abbreviations Afib or AF Atrial Fibrillation FDA Food & Drug Administration PMA Pre-Market Approval AFL Atrial Flutter AT Atrial Tachycardia AAD Anti-Arrhythmic Drugs Abbreviations LAA Left Atrial Appendage LAAM LAA Management PVI Pulmonary Vein Isolation MAE Material Adverse Event CEC Clinical Events Committee EP Electrophysiologist Key Abbreviations: Double check references still link to presentation; add new references