UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 9, 2023
(Exact name of registrant as specified in charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of Principal Executive Offices, and Zip Code)
(513 ) 755-4100
(Registrant’s Telephone Number, Including Area Code)
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):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
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 o
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. o
Item 2.02. Results of Operations and Financial Condition.
On January 9, 2023, 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, 2022. 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 9, 2023 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.
Information in the presentation and the press release 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 9.01. Financial Statements and Exhibits.
(d)Exhibits
| No. | Description | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
| 104 | Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document. | |||||||
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.
| ATRICURE, INC. | |||||||||||
| Dated: | January 9, 2023 | By: | /s/ Angela L. Wirick | ||||||||
| Angela L. Wirick | |||||||||||
| Chief Financial Officer | |||||||||||
 | Exhibit 99.1 | ||||
For immediate release
January 9, 2023
AtriCure Reports Preliminary Results for Fourth Quarter and Full Year 2022,
Provides Financial Outlook for 2023
MASON, Ohio, January 9, 2023 – AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, announced preliminary financial results for the fourth quarter and full year 2022 and provided 2023 financial guidance.
Preliminary, unaudited revenue for fourth quarter 2022 is expected to be approximately $88.0 million, reflecting growth of approximately 20% over the fourth quarter of 2021 (21% on a constant currency basis). U.S. revenue is expected to be $73.9 million, reflecting growth of 21% as demand across key product lines continues to increase. International revenue is expected to be approximately $14.1 million, an increase of 18% as reported (25% on a constant currency basis).
Preliminary, unaudited revenue for full year 2022 is expected to be $330.4 million, reflecting growth of approximately 20% over full year 2021 (22% on a constant currency basis). As previously communicated, adjusted EBITDA for the full year 2022 is estimated to be a loss of approximately $4 million and adjusted loss per share for the full year 2022 is estimated at approximately $1.10 to $1.12. Adjusted EBITDA, adjusted loss per share and constant currency revenue growth are non-GAAP measures. AtriCure will provide a reconciliation of non-GAAP measures to the related GAAP measure in the release of audited 2022 results.
“Our fourth quarter results add to an outstanding year of global patient impact, as our broad portfolio of solutions for the treatment of Afib and post-operative pain management drove accelerated growth,” said Michael Carrel, President and Chief Executive Officer of AtriCure. “We have substantial growth opportunities ahead and remain committed to advancing standards of care for millions of patients in our addressable markets.”
2023 Financial Guidance
Management projects 2023 revenue of approximately $380 million to $387 million, reflecting growth of approximately 15% to 17% over full year 2022. Adjusted EBITDA is estimated to break even for the full year 2023, with improvements annually thereafter.
About AtriCure
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 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 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 LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. 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. This press release also includes forward-looking projected financial information that is based on
current estimates and forecasts. Actual results could differ materially. 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/forward-looking-statements as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. Except where otherwise noted, the information contained in this release is as of January 9, 2023. We assume no obligation to update any forward-looking statements contained in this release and the related attachment as a result of new information or future events or developments, except as may be required by law.
CONTACTS:
Angie Wirick
AtriCure, Inc.
Chief Financial Officer
(513) 755-5334
awirick@atricure.com
Lynn Lewis or Marissa Bych
Gilmartin Group
Investor Relations
lynn@gilmartinir.com
marissa@gilmartinir.com
Creating a World Class Platform JANUARY 2023 © 2023 AtriCure, Inc. All rights reserved. J.P. MORGAN HEALTHCARE CONFERENCE Exhibit 99.2
Forward Looking Statements This presentation and oral statements made in connection with this presentation contain “forward-looking statements,” which are statements related to future events that by their nature address matters that are uncertain. Forward-looking statements address, among other things, AtriCure’s expected market opportunity, future business, financial performance, financial condition, and results of operations, and often contain words such as “intends,” “estimates,” “anticipates,” “hopes,” “projects,” “plans,” “expects,” “drives,” “seek,” “believes,” "see," “should,” “will,” “would,” “can,” “opportunity,” “target,” “outlook,” and similar expressions and the negative versions thereof. Such statements are based only upon current expectations of AtriCure. All forward-looking information is inherently uncertain and actual results may differ materially from assumptions, estimates, projections or expectations reflected or contained in the forward-looking statements as a result of various risk factors. 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. These risks, uncertainties and other factors include, but are not limited to, those identified at http://www.atricure.com/forward-looking-statements and/or described in AtriCure’s Annual Reports on Form 10-K and Quarterly Reports on Form 10- Q, particularly the “Risk Factors” sections thereof, as filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov. With respect to all 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. Forward-looking statements speak only as of the date they are made. AtriCure undertakes no obligation, and does not expect, to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law. © 2023 AtriCure, Inc. All rights reserved. 2
Non-GAAP Financial Measures To supplement AtriCure’s condensed consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, AtriCure provides certain non-GAAP financial measures as supplemental financial metrics in this presentation. Adjusted EBITDA is calculated as net income (loss) before other income/expense (including interest), income tax expense, depreciation and amortization expense, share-based compensation expense, acquisition costs, legal settlement costs, impairment of intangible asset and change in fair value of contingent consideration liabilities. Management believes 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 results of operations and management believes that the excluded items are typically not reflective of our ongoing core business operations and financial condition. Further, management uses adjusted EBITDA for both strategic and annual operating planning. The non-GAAP financial measures used by AtriCure may not be the same or calculated in the same manner as those used and calculated by other companies. Non- GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for AtriCure’s financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financials measures, and not to rely on any single financial measure to evaluate our business. © 2023 AtriCure, Inc. All rights reserved. 3
Afib: A Serious Problem © 2023 AtriCure, Inc. All rights reserved. 4 8 Million2 Atrial Fibrillation (Afib) is an irregular heartbeat (or arrhythmia) that affects more than 37 million people worldwide.1 1 in 4 Adults Over 40 will develop Afib in their lifetime4 8 Million People estimated to have Afib in the US2 3.5 Million People estimated to have long-standing persistent Afib in the US3
Afib: A Serious Problem © 2023 AtriCure, Inc. All rights reserved. 5 5x Higher Risk of Stroke5 46% Greater Risk of Mortality6 >5x Higher Risk of Heart Failure7 Afib is tied to higher risk of stroke, heart failure, dementia, and other health problems
Durable Growth Strong history of revenue growth and acceleration from multiple catalysts Expansion Developing addressable markets and expanding patient impact globally Innovation Continuous improvement, increasing pipeline AtriCure: Foundation for Success © 2023 AtriCure, Inc. All rights reserved. 6 Clinical Science Differentiated clinical trials with superior patient outcomes
Innovative and Expanding Product Portfolio © 2023 AtriCure, Inc. All rights reserved. Ablation LAA Management EPI-SENSE® DEVICE ATRICLIP PRO•V® DEVICE ATRICLIP FLEX•V® DEVICE cryoICE® CRYOABLATION PROBE ISOLATOR® SYNERGY™ CLAMP ATRICLIP® FLEX DEVICE ATRICLIP PRO® DEVICE cryoSPHERE® CRYOABLATION PROBE ISOLATOR SYNERGY ENCOMPASS® CLAMP 7 Continuous innovation to less invasive, simpler to use, more efficient products
Isolator® Synergy Ablation System approved by FDA for treatment of persistent or long-standing persistent Afib concomitant to open heart procedures CONVERGE IDE Trial: EPi-Sense® Guided Coagulation System approved by FDA for treatment of long-standing persistent Afib FROST Study: Pain Management in Post Thoracic Procedures via intercostal Cryoanalgesia Differentiated and Growing Clinical Evidence © 2023 AtriCure, Inc. All rights reserved. 8 2011 2021 2020 CAPLA Study8: Catheter ablation for persistent Afib – a multicenter randomized study of PVI alone vs. PVI with PWI 2022 Registries and Studies Cryoanalgesia Hybrid Therapy LAAM IST HEAL-IST IDE Trial procedure for treatment of IST LeAAPS IDE Trial prophylactic LAA exclusion for prevention of ischemic stroke in cardiac surgery patients without pre-operative AF diagnosis Future evidence expanding markets, changing standards of care
~$900M Concomitant Open Procedures (Open Ablation/LAAM) Cardiac Surgery Opportunity (US) © 2023 AtriCure, Inc. All rights reserved. ~$500M annually Cardiac Surgery with pre-op Afib Estimated penetration <30% Market opportunity and penetration estimates based on internal estimates and research, as well as from publicly available information. 9 ~$375M annually Cardiac Surgery without pre-op Afib Expansion with LeAAPS IDE Clinical Trial AtriCure Difference Innovation • Isolator Synergy EnCompass® Clamp • AtriClip® platform and expansion of labeling (electrical isolation of LAA) Science • Isolator® Synergy Ablation System first medical device with FDA approval for treatment of persistent Afib Education • Advanced Ablation Courses endorsed by the Society of Thoracic Surgeons Guidelines9 • Surgical Ablation is recommended • LAA management is reasonable
Hybrid Opportunity (US) © 2023 AtriCure, Inc. All rights reserved. >$2B and growing Long-standing Persistent Afib patients (untreated) Market size estimated at 5% penetration Market opportunity and penetration estimates based on internal estimates and research, as well as from publicly available information. 10 ~$500M annually Long-Standing Persistent Afib catheter ablations Hybrid Therapy complementary to existing catheter ablations; Estimated penetration <15% $2B+ and Growing Standalone Hybrid Procedures (MIS Ablation/LAAM) AtriCure Difference Innovation • Multiple approaches to treatment: Hybrid AF Therapy + AtriClip®, DEEP • EPi-Sense ST approval Science • EPi-Sense® System approved by FDA for treatment of long-standing persistent Afib Education • Hybrid Training Course co- sponsored by the Hearth Rhythm Society
66% 61% 37% 26% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 12 months 18 months Convergent Catheter Ablation • Superior outcomes with hybrid Convergent procedure when compared to endocardial catheter ablation alone in patients with drug refractory long- standing persistent Afib, with majority of patients experiencing: + Over 100% improvement at 18 months + Over 90% burden reduction at 12 months + Freedom from Afib through 12 months • Improved EP lab efficiency demonstrated by reduction in endocardial ablation time as a result of adding epicardial ablation • Emphasizes value of team approach for advanced AF treatment, targeting trigger areas (epi-cardial and endo-cardial) where AF begins CONVERGE: Long-standing Persistent Afib Patient Analysis © 2023 AtriCure, Inc. All rights reserved. p = 0.022 p = 0.006 Freedom from AF/AFL/AT from 3-month blanking period through 12-months and 18-months 35% differential >100% improvement 29% differential ~78% improvement 11
Pain Management Opportunity (US) © 2023 AtriCure, Inc. All rights reserved. ~$350M annually Thoracic Procedures Estimated penetration <15% Market opportunity and penetration estimates based on internal estimates and research, as well as from publicly available information. 12 ~$600M annually Sternotomy Procedures Therapy under evaluation; expansion with existing cryoSPHERE probe ~$1B Pain Management Procedures (Ablation) AtriCure Difference Innovation • cryoSPHERE® cryoablation probe • Expanded labeling for Cryo Nerve Block Therapy in adolescents (patients as young as 12 years of age) Science • FROST Study • Can be an important tool in combatting the opioid epidemic – 1 in 7 thoracic surgery patients become reliant upon opioids after their procedure10
Significant Global Market Opportunity © 2023 AtriCure, Inc. All rights reserved. Dedicated sales and training expertise $5B+ Global Opportunity LOW PENETRATION IN EXISTING MARKETS EXPANSION OPPORTUNITIES IN FOCUS 13 Market opportunity and penetration estimates based on internal estimates and research, as well as from publicly available information. Enhanced reimbursement Data supporting label expansions Innovative product development Penetration of large markets first Expand product availability
Financial Results and 2023 Outlook © 2023 AtriCure, Inc. All rights reserved. * 2022 is Revenue is preliminary and unaudited. 2022 Adjusted EBITDA based on 2022 guidance for a loss of approximately $4 million. ** 2023 Revenue based on midpoint of Revenue guidance range. 2023 Adjusted EBITDA based on guidance to breakeven for 2023. 14 2023 Guidance • Worldwide revenue of $380-387 million (~15-17% annual growth) • Maintaining Gross Margin • Improving Adjusted EBITDA to breakeven for 2023 COVID19 IMPACT W or ld w id e R ev en ue A dj us te d EB IT D A ($ Millions) History of Consistent Revenue Growth 5-Year organic revenue CAGR (pre-COVID19) ~15% Accelerating growth in 2021 and beyond Significant Investments in Growth Catalysts
Commitment to Sustainability © 2023 AtriCure, Inc. All rights reserved. 15 35th All Top 10 Heart Hospitals Use AtriCure Products US NEWS & WORLD REPORT BEST HOSPITALS: CARDIOLOGY AND HEART SURGERY 2022-23 >800 attendees Inaugural sustainability report published ESG NACD Diversity & Inclusion award recognizing ATRC Board At First Women’s Cardiac Health Awareness Initiative Top Workplace Honors Cincinnati, Minneapolis, Amsterdam Anniversary of Cox-Maze Procedure Global headcount passes the millennium mark – with improvement to diversity metrics! >1,000 Employees
Large Markets Addressing an underserved and growing patient population Strong Portfolio Existing products and solutions driving consistent growth Bright Future Novel therapies supported by growing body of clinical evidence We are passionately focused on healing the lives of those affected by Afib and pain after surgery © 2023 AtriCure, Inc. All rights reserved. 16
Thank You! © 2023 AtriCure, Inc. All rights reserved.
References and Abbreviations © 2023 AtriCure, Inc. All rights reserved. Note Reference 1 European Heart Journal – Quality of Care and Clinical Outcomes (2021) 7, 574-582 doi: 10.1093/ehjqcco/qcaa061 2 The American Journal of Cardiology (2013), 112: 1142-1147 3 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 4 Lifetime risk for development of atrial fibrillation. Circulation, 110 (2004): 1042-1046. doi: 10.1161/01.CIR.0000140263.20897.42 5 J Geriatr Cardiol. 2016 Oct; 13(10): 880–882, doi: 10.11909/j.issn.1671-5411.2016.10.004 6 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 7 Santhanakrishnan R et al., “AF Begets Heart Failure and Vice Versa,” Circulation, 133 (2016):484-492 8 American Heart Journal. 2022 Jan;243:210-220. doi: 10.1016/j.ahj.2021.09.015. 9 The Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation 10 The Society of Thoracic Surgeons, Current News Release (1/30/2018): 1 in 7 Lung Surgery Patients at Risk for Opioid Dependence Key Abbreviations Afib or AF Atrial Fibrillation AFL Atrial Flutter AT Atrial Tachycardia EP Electrophysiologist FDA Food & Drug Administration IDE Investigational Device Exemption IST Inappropriate Sinus Tachycardia LAA Left Atrial Appendage LAAM LAA Management PVI Pulmonary Vein Isolation PWI Posterior Wall Isolation 18