UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): January 7, 2019
ATRICURE, INC.
(Exact name of registrant as specified in charter)
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Delaware (State or other jurisdiction of incorporation) |
000-51470 (Commission File Number) |
34-1940305 (IRS Employer Identification No.) |
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7555 Innovation Way Mason, OH (Address of principal executive offices) |
45040 (Zip Code) |
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Registrant's telephone number, including area code: (513) 755-4100
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02.Results of Operations and Financial Condition.
On January 7, 2019, AtriCure, Inc. (“AtriCure” or the “Company”) issued a press release announcing its preliminary financial results for the fourth quarter and full year ended December 31, 2018. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
Item 7.01.Regulation FD Disclosure.
During the week of January 7, 2019, the Company is holding meetings with investors discussing, among other topics, an overview of the Company’s business and growth strategy. A copy of the investor presentation, which is available at www.atricure.com, is furnished as Exhibit 99.2 to this Form 8-K and is incorporated herein by reference.
The Company’s presentation discloses certain financial results both in accordance with generally accepted accounting principles (“GAAP”) and on a non-GAAP basis with adjustments for certain items. The Company’s management believes that presentation of these non-GAAP financial measures and their related reconciliations are useful to investors because the non-GAAP financial measures provide investors with a basis for comparing the results to financial results from prior periods.
Information in the presentation contains forward-looking statements regarding future events and performance of the Company. All such forward-looking statements are based largely on the Company’s experience and perception of current conditions, trends, expected future developments and other factors, and on management’s expectations, and are subject to risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those factors described in the presentation and in the Company’s filings with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any financial or other projections or other forward-looking statements, whether because of new information, future events or otherwise.
The information in each of Item 2.02 and Item 7.01 of this Form 8-K and in the press release attached as Exhibit 99.1 and the presentation attached as Exhibit 99.2 is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in each of Item 2.02 and Item 7.01 of this Form 8-K and each of Exhibit 99.1 and Exhibit 99.2 shall not be incorporated by reference in any filing (whether made before or after the date hereof) or any other document under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filing or document.
Item 9.01Financial Statements and Exhibits.
(d)Exhibits
99.1Press Release dated January 7, 2019
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ATRICURE, INC. |
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Dated: |
January 7, 2019 |
By: |
/s/ M. Andrew Wade |
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M. Andrew Wade |
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Senior Vice President and Chief Financial Officer |
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Exhibit 99.1 |
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For immediate release
January 7, 2019
AtriCure Reports Preliminary Results for Fourth Quarter and Full Year 2018
MASON, Ohio, January 7, 2019 – AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced preliminary financial results for the fourth quarter and full year 2018 and provided 2019 financial guidance.
Preliminary, unaudited revenue for fourth quarter 2018 is expected to be approximately $52.9 million, reflecting growth of approximately 15% over the fourth quarter of 2017. Based on this preliminary estimate, revenue from U.S. customers is expected to be $43.1 million, reflecting growth of 19% and driven again by strong sales of open-heart ablation products and appendage management products. Revenue from international customers is expected to be approximately $9.8 million, a decrease of 1% as reported and an increase of 1% on a constant currency basis.
Preliminary revenue for full year 2018 is expected to be $201.6 million, reflecting growth of approximately 15% over full year 2017. Adjusted EBITDA (a non-GAAP measure consistently calculated as in previous releases1) for the full year 2018 is currently estimated to be a loss in the previously communicated range of $1 to $3 million.
“We are pleased with our fourth quarter results and performance throughout 2018, as we continue our track record of strong, consistent revenue growth. We achieved many milestones and accomplishments in 2018: we completed enrollment in the CONVERGE IDE trial, trained over 400 healthcare professionals worldwide, surpassed the 170,000 AtriClip milestone, launched the AtriClip FLEXV® device, and established a dedicated pain management team,” said Mike Carrel, President and Chief Executive Officer of AtriCure. “We are well positioned to continue executing on our strategy and positively impacting patient lives.”
2019 Financial Guidance
Management projects 2019 revenue of approximately $220 million to $228 million, reflecting growth of approximately 9% to 13% over full year 2018. Adjusted EBITDA, a non-GAAP measure, is projected to be positive for 2019.
About AtriCure
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold left atrial appendage management devices worldwide, with more than 170,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Forward-Looking Statements
This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/fls as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We do not undertake to update our forward-looking statements. This document also includes forward-looking projected financial information that is based on current estimates and forecasts. Actual results could differ materially.
1 AtriCure will provide a reconciliation of non-GAAP measures to the related GAAP measure in the release of final 2018 results.
CONTACTS:
Andy Wade
AtriCure, Inc.
Senior Vice President and Chief Financial Officer
(513) 755-4564
awade@atricure.com
Lynn Pieper Lewis
Gilmartin Group
Investor Relations
(415) 937-5402
lynn@gilmartinir.com
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Exhibit 99.2
AtriCure Investor Presentation January 2019 © 2019 AtriCure, Inc. All rights reserved. AtriCure 1
Forward Looking Statements 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 our actual results to be materially different than those expressed in our forward-looking statements, see our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC and available at http://www.sec.gov, which contain risk factors. Forward-looking statements address our 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. With respect to the forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law. AtriCure 2
Non-GAAP Financial Measures To supplement the Company’s consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, the Company uses certain non-GAAP financial measures in this presentation. Adjusted EBITDA, which the Company defines as earnings before interest, taxes, depreciation and amortization, adjusted for share-based compensation and the change in fair value of contingent consideration, provides an indication of performance excluding certain items. Management believes that in order to properly understand short-term and long-term financial trends, investors may wish to consider the impact of these excluded items in addition to GAAP measures. The excluded items vary in frequency and/or impact on our continuing operations and management believes that the excluded items are typically not reflective of our ongoing core business operations. Further, management uses adjusted EBITDA for its strategic planning. A reconciliation of adjusted EBITDA to the most comparable GAAP measure for the respective periods can be found in the Supplemental Information section of this presentation. The non-GAAP financial measures used by the Company may not be the same or calculated the same as those used by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for the Company’s financial results prepared and reported in accordance with GAAP. AtriCure 3
Atrial Fibrillation Approximately 9% of people over 65 suffer from atrial fibrillation (also called Afib or AF), a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. More than 33 million people are affected worldwide, where 2/3 are not addressed by standard of care. Roughly 1.2 million Afib cases are diagnosed annually in the U.S. © 2019 AtriCure, Inc. All rights reserved. AtriCure 4
Afib: A serious and costly problem Stroke is leading cause of long-term disability Afib increases the risk of stroke by 5x times 3x People with Afib have three times the risk for heart failure #2 Afib is second leading cause of stroke $26 Billion Total cost of Afib to U.S. healthcare each year 73% higher medical costs related to Afib © 2019 AtriCure, Inc. All rights reserved. AtriCure 5
Key Investment Rationale Addressing an underserved and growing population of patients About 17 million chronic Afib patients globally Current standard of care does not adequately address this population Portfolio of Standalone/Minimally Invasive (MIS) solutions to drive long-term growth Two PMA trials underway for hybrid approaches; CONVERGE trial is top priority Early in market development process – key driver of future growth Appendage Management business complements multiple procedures Most widely used Left Atrial Appendage (LAA) device with over 170,000 sold to date Delivering novel products, driving volume and ASP growth Can deepen penetration of Open Heart Ablation through training Only PMA product for the surgical treatment of Afib Product improvements and salesforce focus have driven growth Recent guidelines have driven broader adoption © 2019 AtriCure, Inc. All rights reserved. AtriCure 6
2018 Highlights Achieved over $200 million in revenue and annual growth rate of 15.4% Completed enrollment in CONVERGE clinical trial Trained over 400 healthcare professionals worldwide Impact of innovation continued with successful product launches in 2018 AtriClip Flex·V® device in March (U.S.) Limited US launch of cryoSPHERE™ device for nerve block in November; full U.S. launch in 2019 Built Cryo Nerve Block pilot commercial team Partnered with BaHeal Pharmaceutical Group for distribution in China Strengthened balance sheet with stock offering in October © 2019 AtriCure, Inc. All rights reserved. Atricure 7
Strong Financial Performance Worldwide Revenue 2013-2018 20% CAGR In Millions $ $50 $100 $150 $200 2013 2014 2015 2016 2017 2018 US EMEA Asia Other 25 Straight Quarters of Double-Digit YoY Growth Consistent Growth $201.6M 2018 Revenue 15.4% YoY Growth © 2019 AtriCure, Inc. All rights reserved Atricure 8
Two Distinct Patient Profiles 6 Million Afib patients in the U.S. 3.0M Effectively Treated Medication / Cardioversion 1.4M Paroxysmal (Intermittent Afib) Non-paroxysmal (Continuous Afib_ 1.6M Patients OPEN PROCEDURES ~25% PENETRATED Patients already undergoing heart surgery Afib treatment at time of surgery Pulmonary Vein Isolation Complete Cox-Maze Stand-Alone Procedures ~<5% PENETRATED Treating Afib as a standalone procedure Pulmonary Vein Isolation (Catheter) Hybrid (Surgery + EP Procedure) © 2019 AtriCure, Inc. All rights reserved. AtriCure 9
Looking Forward … U.S. Market - $1 Billion Opportunity 6 million Afib patients in the U.S. Medication / Cardioversion Paroxysmal (Intermittent Afib) Non-paroxysmal (Continuous Afib) 1.6M PATIENTS ADDRESSABLE MARKET OPPORTUNITY OPEN ABLATION $270M Market applies to major forms of structural heart surgery (CABG, AVR, MVR) APPENDAGE MANAGEMENT $290M Market applies to both open chest and minimally-invasive procedures MIS ABLATION $560M Market includes ALL non-paroxysmal Afib patients for whom “management” has not worked © 2019 AtriCure, Inc. All rights reserved. AtriCure 10
Business Evolution to Drive Long-Term Growth ACCELERATING GROWTH $90 Million1 $200 Million1 $560 Million1 CORE BUSINESS EVOLUTION TO DRIVE LONG TERM GROWTH SOLID GROWTH $270 Million1 OPEN ABLATION CURRENT PENETRATION <25% APPENDAGE MANAGEMENT OPEN MIS <5% MIS ABLATION <3% Core business is evolving to serve the MIS market and capture more of long-term growth opportunity 1 Estimated market opportunities; see Supplemental Information section of this presentation for calculations © 2019 AtriCure, Inc. All rights reserved. AtriCure 11
U.S. Open Ablation 90K Cardiac surgeries on patients with pre-existing Afib $270M Market size Competitive Advantages Labeling advantage in the U.S. Robust portfolio across two technology platforms Solid gross margins Strong physician education programs Growth Drivers STS/HRS Class 1 recommendations Focused sales force Major emphasis on physician education and training Continued market penetration driven by CABG opportunity OPEN ABLATION AtriCure has the only ON-LABEL product for the surgical treatment of Afib (FDA approved) Growth will be driven by increased market penetration © 2019 AtriCure, Inc. All rights reserved. AtriCure 12
Surgical Ablation Guidelines are Advancing The Society of Thoracic Surgeons American College of Cardiology American Heart Association ESC European Society of Cardiology Heart Rhythm Society COR LOE 1 1 1 lla lla lla llb llb llb A B C A B C A B C Ablation Considered Ablation Reasonable Albation Recommended Concomitant Mitral Operations Concomitant w/AVR/CABG/AVR+CABG Stand-Alone LAAM NO GUIDELINES 1987 2014 2016 2017 CDR = Class of Recommendation LOE = Level of Evidence © 2019 AtriCure, Inc. All rights reserved. AtriCure 13
U.S. MIS Ablation $560M U.S. Total Market High growth opportunity in underserved and underdeveloped market Competitive Advantages Favorable reimbursement environment High gross margin portfolio Pipeline of continued development Leveraging expertise in epicardial ablation to serve non-paroxysmal opportunity Growth Drivers CONVERGE IDE trial for Afib labeling expansion Cardiologists looking for definitive treatment solutions Tough-to-serve patient population lends itself to multi-disciplinary therapy MIS ABLATION Upcoming clinical data expected to support market development © 2019 AtriCure, Inc. All rights reserved. AtriCure 14
U.S. Appendage Management $290M U.S. Total Market $90M Open Ablation $200M MIS Ablation APPENDAGE MANAGEMENT OPEN and MIS Open Growth Drivers Broadening awareness of benefits of LAA management (science and society endorsement) Launched AtriClip Flex·V® device in March 2018 – benefits include ease of use and lower profile MIS Growth Drivers AtriClip PRO2 device continues to gain traction w/ higher ASP Launch of a more versatile AtriClip PRO·V™ device in September 2017 Future opportunity for adding MIS AtriClips to other procedures APPENDAGE MANAGEMENT Highest growing of our franchises – over 30% CAGR for past three years Over 170,000 AtriClip Systems implanted worldwide © 2019 AtriCure, Inc. All rights reserved AtriCure 15
AtriCure Product Portfolio OPEN ABLATION ISOLATOR® SYNERGY™ CLAMP cryoICE ® CRYOABLATION PROBE cryoFORM ® CRYOABLATION PROBE ISOLATOR ® TRANSPOLAR PEN MIS ABLATION ISOLATOR SYNERGY ACCESS® CLAMP COBRA FUSION ® 150 ABLATION SYSTEM EPI-SENSE ® DEVICE SUBTLE ® CANNULA APPENDAGE MANAGEMENT ATRICLIP ® LONG DEVICE ATRICLIP ® FLEX DEVICE ATRICLIP FLEX V™ DEVICE ATRICLIP PRO ® DEVICE ATRICLIP PRO2 ® DEVICE ATRICLIP PRO V® DEVICE OPEN MIS © 2019 AtriCure, Inc. All rights reserved. AtriCure 16
Expanding Product Portfolio Launched 6 products in last four years (1 from acquisition) Track record of organic and inorganic execution Future pipeline focus across all franchises – Open clamp, linear ablation, minimally invasive AtriClip Innovation toward less invasive, simpler, easier to use, and more efficient products Strong commercial pricing discipline for new product introductions Long-term Goal Continued expansion of products in both core and new markets © 2019 AtriCure, Inc. All rights reserved. AtriCure 17
Advancing Clinical Outcomes Robust clinical program with several studies underway to generate clinical evidence CONVERGE PIVOTAL Trial designed to support FDA approval of EPi-Sense device specifically for the treatment of persistent Afib through an abdominal approach DEEP PIVOTAL Trial designed to support FDA approval of various devices specifically for the treatment of persistent Afib through a bi-lateral totally thoracoscopic approach CEASE AF Randomized trial of hybrid bi-lateral approach (same as DEEP) versus catheter ablation in persistent and longstanding persistent Afib …and many other clinical science studies and activities! © 2019 AtriCure, Inc. All rights reserved. AtriCure 18
CONVERGE Pivotal Study CONVERGE Clinical Trial Trial designed to support FDA approval of EPi-Sense device specifically for the treatment of persistent Afib STUDY DESIGN Summary Multi-center, prospective, open label randomized 2:1 (Convergent procedure vs endocardial catheter ablation) pivotal study. Number of Subjects and Sites Up to 153 subjects Up to 30 sites (27 U.S. and 3 O.U.S.) Study Duration 5 year follow-up of all subjects PRIMARY ENDPOINTS Effectiveness The 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 The primary safety endpoint for the study is 12% freedom from MAE’s as adjudicated by the CEC for the procedural to 30-day post procedure time period. CONVERGE HIGHLIGHTS Completed enrollment in August 2018 © 2019 AtriCure, Inc. All rights reserved. AtriCure 19
Summary of U.S. – Large, Underpenetrated Market Opportunity Open Ablation $65 $270 Appendage Management $37 $290 MIS Albation $34 $560 $0 $100 $200 $300 $400 $500 $600 Potential Market ($M) 2017 Revenue ($M) U.S. GROWTH DRIVER Continued penetration into the Open Market Growing MIS clinical data and continuing commercial execution Appendage Management business complementing growth of Open / MIS Ablation © 2019 AtriCure, Inc. All rights reserved. AtriCure 20
Aligning Expertise With Opportunity Sales structure and talent – maximizing productivity Shifting headcount growth from Regional Sales Managers to Ablation/Clinical Specialists Solid case coverage while managers build relationships, broaden adoption Onboarding and training current team is a top priority Each Area Includes: 5-6 Regional Sales Managers 4-8 Clinical Specialists 1-2 Minimally Invasive Manager(s) Key Sales Positions Area Directors Regional Sales Managers Ablation/Clinical Specialists Minimally Invasive Managers 2013 8 37 22 0 2016 11 53 44 10 2018 11 52 58 15 © 2019 AtriCure, Inc. All rights reserved. AtriCure 21
International Market = $2 Billion Opportunity Mid-teens growth driven by product expansion and reimbursement Growth Drivers Product expansion in Asia Reimbursement in the EU Clinical Data – CEASE AF Sales team coverage $525M OPEN ABLATION $600M APPENDAGE MANAGEMENT $985M MIS ABLATION 2017 International Revenue (M) Open Ablation MIS Ablation App Mgmt $7.3 $8.0 $20.7 © 2019 AtriCure, Inc. All rights reserved. AtriCure 22
Financial Performance Revenue growth expectations fueled by stability in Open ablation and high growth in MIS ablation and Appendage Management Strong historical revenue growth across the business – 25 quarters of double digit year-over-year growth Historical gross margins 70 – 73% with expansion opportunity Continued improvement in profitability profile 2019 Revenue Guidance: $220 million to $228 million (9% to 13% growth) *Non-GAAP measure; see historical reconciliation of Adjusted EBITDA to net loss in the Supplemental Information section of this presentation Adjusted EBITDA 2014 ($12.0)M 2015 ($11.5)M 2016 (9.2M) 2017 ($5.3)M 2018E ($1)M-($3)M REVENUE $107.5M $129.8M $155.1M $174.7M $201.6M © 2019 AtriCure, Inc. All rights reserved. AtriCure 23
Investor Highlights Leader in $1B+ U.S. addressable market for atrial fibrillation solutions Market Leadership Only on-label (FDA) product in the persistent/long-standing persistent Afib market Robust product portfolio and pipeline focused on minimally-invasive solutions Most widely adopted LAA product on the market Strong Growth Opportunity Large and growing market; vastly underpenetrated Evolution to minimally invasive therapies will drive growth Diverse profile of solutions to treat persistent Afib Solid Foundation 20% 5-year revenue CAGR through 2017, with improving profitability Commitment to innovation, education, and clinical science GROWTH DRIVERS Updated society guidelines recommend treatment of Afib for specific procedures Continued penetration in the Open market Growing MIS clinical data and portfolio of solutions Appendage management business driving growth Strengthening commercial leadership and team International expansion © 2019 AtriCure, Inc. All rights reserved. AtriCure 24
Thank You! © 2019 AtriCure, Inc. All rights reserved. AtriCure 25
Supplemental Information Note that citations/references for any comments, statistics, or figures in this presentation are available upon request. © 2019 AtriCure, Inc. All rights reserved. AtriCure 26
Revenue / Market Overview Geography 2016 Full-Year Revenue 2017 Full-Year Revenue 2018 Full-Year Revenue Global Market Potential United States $122.4M +20% $138.4M +13% $162.1M +17% $1B+ Annually International $32.7M +19% $36.3M +11% $39.5M +9% $2B+ Annually Overall $155.1M +20% $174.7M +13% $201.6M +15% $3B+ Annually © 2019 AtriCure, Inc. All rights reserved. AtriCure 27
Franchise / Business Overview Focus Areas Products Keys to Success Trials/Data OPEN Ablation (Concomitant) OPEN Appendage Management MIS Ablation MIS Appendage Management International FDA PMA label for Afib (2011) Advanced Training – CABG/AVR/Fellowships Conversions and add-on sales – cryoFORM adoption Guideline changes w/ Societies EXCLUDE trial (510k data) Continued education and awareness Tie to ablation growth Flex-V AtriClip in 2018Trials – DEEP and CONVERGE Collaborative care Convergent growth ATLAS and other data Awareness Future trials/studies Product expansion (Pro2, Pro-V) Product expansion in Asia Reimbursement in EU Sales team coverage ABLATE IDE = PMA PMA Post Approval Study (365 Patients) STS/Medicare retrospective studies Guidelines key – supporting many grants TRAC-AF registry EXCLUDE – Complete ATLAS/future data opportunities CONVERGE IDE DEEP IDE TRAC-AF Registry Stroke Safety Feasibility Complete Investigating opportunities CEASE AF (DEEP for EU) HISTORIC AF (Complete) Several AtriClip registries © 2019 AtriCure, Inc. All rights reserved. AtriCure 28
AtriCure Portfolio Designed to Treat Afib 2017 U.S. REVENUE BY PRODUCT CATEGORY $64M 47% OPEN ABLATION 2017 STS and HRS guidelines recommend surgical ablation for the treatment of Afib at the time of MVR, AVR, and CABG $37M 27% APPENDANGE MANAGEMENT OPEN 2017 STS Guidelines include LAA Management as a reasonable procedure to minimize risk of stroke MIS Strong existing product line with new product innovations continuing to drive the shift to MIS procedures $34m 25% MIS ABLATION CONVERGE trial underway to support FDA approval of the EPi-Sense® device for the treatment of persistent Afib © 2019 AtriCure, Inc. All rights reserved. AtriCure 29
Keys to Market Development Expand Product Portfolio Innovative pipeline to drive Open ablation penetration and build MIS market AtriClip PRO·V device, AtriClip PRO2 device, cryoFORM probe, Cryo3 probe, etc. Increase Education and Awareness Afib training programs delivered to 2,000+ surgeons UPDATED GUIDELINES STS/HRS Class 1 AATS Advancing Clinical Outcomes Multiple clinical trials underway (PMA and company-sponsored) CONVERGE – Top priority for company…drives MIS opportunity Commercial Talent and Expertise Strong commercial leadership and sales infrastructure Increase size/expertise of MIS-focused team, continue to be seen as Afib resource! © 2019 AtriCure, Inc. All rights reserved. AtriCure 30
Increase Education and Awareness Investment Significant resources toward physician education Multiple options including didactic, hands-on, proctoring, and case observations Steering Committee Comprised of highly regarded KOLs Strong Network Established strong network of revered physician trainers Society Involvement AATS Fellowships, STS and EACTs endorsed training program Trained over 2,000 surgeons worldwide Helping physicians address the growing Afib epidemic © 2019 AtriCure, Inc. All rights reserved. AtriCure 31
Guidelines to Fuel Adoption 2017 STS Guidelines Applies to ALL-COMER Afib patients. Previously only “symptomatic patients refractory or intolerant to at least one AAD”. Surgical Ablation is RECOMMENDED not just reasonable; it doesn’t increase operative risk. LAA Management is mentioned for the first time in the STS Guidelines; LAA Management is reasonable in conjunction with ablation or alone during cardiac surgery. Acknowledges the positive impact of hybrid ablations. 2017 HRS Guidelines Mitral Valve Replacement is RECOMMENDED for all symptomatic patients refractory or prior to antiarrhythmic drugs. Surgical Ablation is RECOMMENDED for CABG and AVR patients who had initiated antiarrhythmics prior to surgery. Stand-Alone / Hybrid is REASONABLE for long-standing persistent symptomatic patients refractory or intolerant to at least one AAD and have failed one or more attempts at catheter ablation or prefer a surgical approach. WHAT’S NEXT? Continuing to educate the market Generate evidence Influence other major societies © 2019 AtriCure, Inc. All rights reserved. AtriCure 32
Society Guidelines for Treatment of Afib SOCIETY RECOMMENDATION STS (2016) 1 Surgical ablation for Afib can be performed without additional operative risk of mortality or major morbidity, and is recommended at the time of concomitant isolated aortic valve replacement, isolated coronary artery bypass graft surgery, and aortic valve replacement plus coronary artery bypass graft operations to restore sinus rhythm. Surgical ablation for Afib can be performed without additional operative risk of mortality or major morbidity, and is recommended at the time of concomitant mitral operations to restore sinus rhythm. AHA/ACC/HRS (2014)2 An Afib surgical ablation procedure is reasonable for selected patients with Afib undergoing cardiac surgery for other indications. A stand-alone Afib surgical ablation procedure may be reasonable for selected patients with highly symptomatic Afib not well managed with other approaches. HRS/ACC/AHA/STS/EHRA/ECAS (2012)3 “It is advisable that all patients with documented Afib referred for other cardiac surgeries undergo a left or biatrial procedure for Afib at an experienced center, unless it…will add significant RISK…” ISMICS (2009)4 “Concomitant surgical ablation is recommended …. to increase the incidence of sinus rhythm both at short- and long-term follow-up …. to improve ejection fraction and exercise tolerance …. to reduce the risk of stroke and thromboembolic events …. and to improve long-term survival.” UK NICE (2014)5 Surgical ablation of Afib should be considered in patients with persistent Afib, or with symptomatic Afib undergoing cardiothoracic surgery. ESC (2010)6 Surgical ablation of Afib should be considered in patients with symptomatic or asymptomatic Afib undergoing cardiac surgery. Minimally invasive surgical ablation of Afib without concomitant cardiac surgery is feasible and may be performed in patients with symptomatic Afib after failure of catheter ablation. 1. Badhwar et al.; Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation, Ann Thorac Surg 2017;103:329-41 2. Craig et al,; 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation, JACC. Vol 64, no 21. 2014 3. Calkins et al.; HRS/EHRA/ECAS Catheter and Surgical Ablation. Heart Rhythm, vol. 9, no 4, April 2012. 4. Ad et al.; Surgical ablation for atrial fibrillation in cardiac surgery. Innovations, vol 5, no 2, March/April 2010. 5. National Institute for Health and Care Excellence. Atrial fibrillation: management, clinical guideline. June 18, 2014. 6. Camm et al.; Guidelines for the management of atrial fibrillation. European Heart Journal, 2010. © 2019 AtriCure, Inc. All rights reserved. AtriCure 33
Society Guidelines for Appendage Management SOCIETY RECOMMENDATION STS (2016) 1 It is reasonable to perform left atrial appendage excision or exclusion in conjunction with surgical ablation for Afib for longitudinal thromboembolic morbidity prevention. AHA/ACC/HRS (2014)2 Surgical excision of the left atrial appendage may be considered in patients undergoing cardiac surgery. UK NICE (2014)5 Consider LAA occlusion if anticoagulation is contraindicated or not tolerated and discuss the benefits and risks of LAA occlusion with patient. EJCTS (2013)4 We conclude that there has been no proven benefit of surgical LAA exclusion in terms of stroke reduction or mortality benefit… If exclusion is contemplated, devices designed for appendage exclusion should be used rather than a cut-and-sew or stapling technique. EHRA/EAPCI (2014)5,6 OAC (with VKA or NOACs) is the standard therapy; however, for patients who are contraindicated or refuse (N) OACs… the main indication for LAA occlusion is a relative or absolute contraindication to (N)OACs in patients with Afib and a CHADS2 score of ≥1 or CHA2 -DS2 -VASc score ≥2. 1. Badhwar et al.; Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation, Ann Thorac Surg 2017;103:329-41 2. January et al.; AHA/ACC/HRS Atrial Fibrillation Guideline. JACC Vol. 64, no. 21. December 2, 2014. 3. National Institute for Health and Care Excellence. Atrial fibrillation: management, clinical guideline. June 18, 2014. 4. Dunning et al.; Guideline for the surgical treatment of atrial fibrillation. European Journal of Cardio-Thoracic Surgery. Vol 44. 2013. 5. Meier et al.; EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion. EuroIntervention. 2014 6. Thambo et al.; The future of left atrial appendage occlusions: When extraordinary claims require evidence… Archives of Cardiovascular Disease 2015 vol 108. © 2019 AtriCure, Inc. All rights reserved. AtriCure 34
U.S. Open Market Work-Up Total Open U.S. Procedures 300,000 30% with Afib U.S. Procedures with Afib 90,000 ~ U.S. Annual Opportunity1 $270M ~Current U.S. OPEN Ablation penetration, 25% 2017 U.S. Open Ablation Sales $65M 1. Assumes Open ablation procedural pricing of $3,000. © 2019 AtriCure, Inc. All rights reserved. AtriCure 35
U.S. Appendage Management Market Work-Up OPEN APPENDAGE MANAGEMENT Total Open U.S. Procedures 300,000 30% with Afib U.S. Procedures with Afib 90.000 ~U.S. Annual Opportunity2 $90M MIS APPENGAGE MANAGEMENT Non-paroxysmal Pts Annually Treated with Cath Ablation 80,000 ~Unsuccessful Outcomes with Cath Ablation, 70% MIS Ablations (Non-paroxysmal, post Cath) 56,000 ~ Annual U.S. MIS Ablation Opportunity (Post Cath)1 $200M 2017 U.S. Appendage Management Sales $37M ~Current U.S. OPEN / MIS Appendage Management penetration, ~10% 1. Assumes average pricing of $3,600 for MIS AtriClip 2. Assumes average pricing of $1,000 for Open AtriClip © 2019 AtriCure, Inc. All rights reserved. AtriCure 36
U.S. MIS Market Work-Up Non-paroxysmal Pts Annually Treated with Cath Ablation 80,000 ~Unsuccessful Outcomes with Cath Ablation, 70% MIS Ablations (Non-paroxysmal, Post Cath) 56,000 ~ Annual U.S. MIS Ablation Opportunity1 $560M ~Current MIS OPEN Ablation penetration, ~5% 2017 U.S. MIS Ablation Sales $34M 1. Assumes MIS ablation procedure pricing of $10,000 © 2019 AtriCure, Inc. All rights reserved. AtriCure 37
Additional Growth Drivers with Appendage Management Prophylactic treatment for Open Appendage Management Additional $500M global market Total OPEN U.S. Procedures 300,000 70% without Afib ~U.S. Procedures without Afib 210,000 ~U.S. LAA Prophylactic Annual Opportunity2 $215M Sole Therapy Appendage Management Market Competition includes implants and EP closure (without FDA approval) Stroke trial key to success Treatment Resistant Afib Patients in the U.S. 333,333 10% treated annually ~Annual Market Opportunity1 $120M MIS Appendage Management with Heart Procedures Opportunity for other MIS surgeries, such as valve repair Market is currently small but fast growing Yearly MIS Heart Procedures (Valve Replacements, MIS CABG) 333,333 ~Annual Market Opportunity1 $540M 1. Assumes average pricing of $3,600 for MIS AtriClip 2. Assumes average pricing of $1,000 for Open AtriClip © 2019 AtriCure, Inc. All rights reserved. AtriCure 38
Adjusted EBITDA Reconciliation (millions of dollars) Net loss, as reported ($16.2) ($27.2) ($33.3) ($26.9) Income tax expense $0.0 $0.0 $0.0 $0.0 Other (income)/expense, net ($0.2) $0.5 $2.2 $1.9 Depreciation and amortization expense $4.8 $6.3 $9.3 $9.1 Share-based compensation expense $7.6 $9.0 $11.7 $14.6 Change in fair value of contingent consideration ($8.0) - $1.0 ($4.1) Adjusted EBITDA ($12.0) ($11.5) ($9.2) ($5.3) © 2019 AtriCure, Inc. All rights reserved. AtriCure 39
Non-Drug Options of Care For Non-Paroxysmal Afib Least Painful / Invasive Most Effective THERAPY ACUTE CLINICAL SUCCESS Catheter Ablation (Endocardial 30% single treatment Hybrid – CONVERGENT (Trans-Diaphragmatic) 70-80% on AADs 60-65% off AADs Hybrid – DEEP (Bi-Laterl Totally -Thoracoscopic) 80-90% on AADs 70-80% off AADs Cox-Maze Ablation (Right-Laterl Thoracotomy) 90+% on AADs Cut-and-Sew Cox-Maze 95+% on AADs © 2019 AtriCure, Inc. All rights reserved. AtriCure 40
Cox-Maze IV Procedure Left Atrial Appendage Coronary Sinus Mitral Annulus Circumflex Coronary Artery SVC Right Atrial Appendage Right Coronary Artery Tricuspid Annulus IVC Bipolar RF Clamp Surgical Incision Cryo – Endocardial Cryo- Epicardial © 2019 AtriCure ,Inc. All rights reserved. AtriCure 41