UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
_____________________________________________
FORM
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For the quarterly period ended
or
For the transition period from_____________to_____________
Commission File Number
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(Exact name of Registrant as specified in its charter)
_____________________________________________
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(State or other jurisdiction of incorporation) | (IRS Employer Identification No.) |
(Address of principal executive offices)
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(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: YES NO ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES NO ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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x | Accelerated Filer | ¨ | |||
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Non-Accelerated Filer | ¨ | Smaller reporting company |
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Emerging growth company |
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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: ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): YES ¨ NO
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
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Class | Outstanding at April 26, 2021 |
Common Stock, $.001 par value |
Table of Contents
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Item 1. |
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| Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020 | 3 |
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| 5 | |
| Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2021 and 2020 | 6 |
| 7 | |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 19 |
Item 3. | 23 | |
Item 4. | 23 | |
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Item 1. | 23 | |
Item 1A. | 24 | |
Item 6. | 25 | |
26 |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ATRICURE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Per Share Amounts)
(Unaudited)
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| March 31, |
| December 31, | ||
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| 2020 | ||
Assets |
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Current assets: |
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Cash and cash equivalents |
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Short-term investments |
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Accounts receivable, less allowance for credit losses of $ |
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Inventories |
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Prepaid and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Long-term investments |
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Intangible assets, net |
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Goodwill |
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Other noncurrent assets |
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Total Assets |
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| $ | |
Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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Accrued liabilities |
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Other current liabilities and current maturities of debt and leases |
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Total current liabilities |
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Long-term debt |
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Finance lease liabilities |
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Operating lease liabilities |
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Contingent consideration and other noncurrent liabilities |
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Total Liabilities |
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Commitments and contingencies (Note 7) |
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Stockholders’ Equity: |
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Common stock, $ outstanding |
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Additional paid-in capital |
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Accumulated other comprehensive (loss) income |
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Accumulated deficit |
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Total Stockholders’ Equity |
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Total Liabilities and Stockholders’ Equity |
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| $ | |
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See accompanying notes to condensed consolidated financial statements.
ATRICURE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In Thousands, Except Per Share Amounts)
(Unaudited)
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| Three Months Ended | ||||
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| 2020 | ||
Revenue |
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| $ | |
Cost of revenue |
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Gross profit |
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Operating expenses: |
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Research and development expenses |
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Selling, general and administrative expenses |
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Total operating expenses |
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Loss from operations |
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Other income (expense): |
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Interest expense |
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Interest income |
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Other |
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Loss before income tax expense |
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Income tax expense |
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Net loss |
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Basic and diluted net loss per share |
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| $ | ( |
Weighted average shares outstanding—basic and diluted |
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Comprehensive loss: |
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Unrealized loss on investments |
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Foreign currency translation adjustment |
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Other comprehensive loss |
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Net loss |
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Comprehensive loss, net of tax |
| $ | ( |
| $ | ( |
See accompanying notes to condensed consolidated financial statements.
ATRICURE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In Thousands)
(Unaudited)
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| Three-Month Period Ended March 31, 2020 | |||||||||||||||
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| Accumulated |
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| Additional |
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| Other |
| Total | |||
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| Paid-in |
| Accumulated |
| Comprehensive |
| Stockholders’ | |||||||
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| Shares |
| Amount |
| Capital |
| Deficit |
| Income (Loss) |
| Equity | |||||
Balance—December 31, 2019 |
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| $ | |
| $ | ( |
| $ | ( |
| $ | |
Impact of equity compensation plans |
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Other comprehensive loss |
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Net loss |
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Balance—March 31, 2020 |
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| Three-Month Period Ended March 31, 2021 | |||||||||||||||
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| Accumulated |
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| Additional |
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| Other |
| Total | |||
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| Paid-in |
| Accumulated |
| Comprehensive |
| Stockholders’ | |||||||
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| Amount |
| Capital |
| Deficit |
| Income (Loss) |
| Equity | |||||
Balance—December 31, 2020 |
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| $ | |
| $ | ( |
| $ | |
| $ | |
Impact of equity compensation plans |
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Other comprehensive loss |
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Net loss |
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Balance—March 31, 2021 |
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| $ | |
| $ | ( |
| $ | ( |
| $ | |
See accompanying notes to condensed consolidated financial statements.
ATRICURE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(Unaudited)
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| Three Months Ended | ||||
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| 2020 | ||
Cash flows from operating activities: |
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Net loss |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Share-based compensation expense |
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Depreciation |
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Amortization of intangible assets |
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Amortization of deferred financing costs |
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Loss on disposal of property and equipment |
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Amortization (accretion) of investments |
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Change in value of contingent consideration |
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Other non-cash adjustments to income |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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Inventories |
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Other current assets |
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Accounts payable |
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Accrued liabilities |
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Other noncurrent assets and liabilities |
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Net cash used in operating activities |
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Cash flows from investing activities: |
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Sales and maturities of available-for-sale securities |
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Purchases of property and equipment |
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Net cash provided by investing activities |
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Cash flows from financing activities: |
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Payments on debt and leases |
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Proceeds from stock option exercises and employee stock purchase plan |
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Shares repurchased for payment of taxes on stock awards |
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Net cash used in financing activities |
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Effect of exchange rate changes on cash and cash equivalents |
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Net increase (decrease) in cash and cash equivalents |
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Cash and cash equivalents—beginning of period |
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Cash and cash equivalents—end of period |
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Supplemental cash flow information: |
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Cash paid for interest |
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Cash paid for income taxes, net of refunds |
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Non-cash investing and financing activities: |
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Accrued purchases of property and equipment |
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See accompanying notes to condensed consolidated financial statements.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
The accompanying Condensed Consolidated Financial Statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
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| March 31, |
| December 31, | ||
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| 2020 | ||
Raw materials |
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Work in process |
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Finished goods |
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Inventories |
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| Estimated Useful Life |
Generators and related equipment | |
Building under finance lease | |
Computers, software and office equipment | |
Machinery and equipment | |
Furniture and fixtures | |
Leasehold improvements | |
Equipment under finance leases |
The Company assesses the useful lives of property and equipment at least annually and retires assets no longer in use. Maintenance and repair costs are expensed as incurred. The Company reviews property and equipment for impairment at least annually using its best estimates based on reasonable and supportable assumptions and expected future cash flows. Property and equipment impairments have not been significant.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
the Company may have a full or partial impairment charge related to the IPR&D, calculated as the excess carrying value of the IPR&D assets over the estimated fair value.
The Company’s estimate of the valuation allowance for deferred income tax assets requires significant estimates and judgments about future operating results. Deferred income tax assets are reduced by valuation allowances if, based on the consideration of all available evidence, it is more-likely-than-not that the deferred income tax asset will not be realized. Significant weight is given to evidence that can be objectively verified. The Company evaluates deferred income tax assets on an annual basis to determine if valuation allowances are required. Deferred income tax assets are realized by having sufficient future taxable income to allow the related tax benefits to reduce taxes otherwise payable. The sources of taxable income that may be available to realize the benefit of deferred income tax assets are future taxable income, future reversals of existing taxable temporary differences, carryforwards and tax planning strategies that are both prudent and feasible. In evaluating the need for a valuation allowance, the existence of cumulative losses in recent years is significant objectively verifiable negative evidence that must be overcome by objectively verifiable positive evidence to avoid the need to record a valuation allowance. The Company has recorded a full valuation allowance against substantially all net deferred income tax assets as it is more-likely-than-not that the benefit of the deferred income tax assets will not be recognized in future periods. The Company has not reclassified income tax effects of the Tax Cuts and Jobs Act within accumulated other comprehensive income (loss) to retained earnings due to its full valuation allowance.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
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| Three Months Ended | ||||
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| March 31, | ||||
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| 2020 | ||
Total accumulated other comprehensive income (loss) at beginning of period |
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Unrealized Gains (Losses) on Investments |
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Balance at beginning of period |
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Other comprehensive loss before reclassifications |
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Amounts reclassified from accumulated other comprehensive income (loss) to other income (expense) |
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Balance at end of period |
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Foreign Currency Translation Adjustment |
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Balance at beginning of period |
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Other comprehensive loss before reclassifications |
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Amounts reclassified from accumulated other comprehensive income (loss) to other income (expense) |
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Balance at end of period |
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Total accumulated other comprehensive loss at end of period |
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The Company estimates the fair value of time-based options on the date of grant using the Black-Scholes option-pricing model (Black-Scholes model). The Company’s determination of the fair value is affected by the Company’s stock price, as well as assumptions regarding several subjective variables. These variables include, but are not limited to, the Company’s expected stock price volatility over the term of the awards and actual and projected employee stock option exercise behaviors. The Company estimates the fair value of restricted stock awards and restricted stock units based upon the grant date closing market price of the Company’s common stock.
The Company estimates the fair value of PSAs with a performance condition based on the closing stock price on the date of grant assuming the performance goal will be achieved and may adjust expense over the performance period based on changes to estimates of performance target achievement. If such goals are not met or service is not rendered for the requisite service period, no compensation cost is recognized, and any recognized compensation cost will be reversed. For PSAs with a market condition, a Monte Carlo simulation is performed to estimate the fair value on the date of grant, and compensation cost is recognized over the requisite service period as the employee renders service, even if the market condition is not satisfied. The Company’s determination of the fair value is affected by the Company and peer group’s stock price at the beginning of the service period and grant date, the expected volatility of the Company and peer group’s stock price over the performance period and the correlation coefficient of the daily returns for the Company and peer group over the performance period.
The Company also has an employee stock purchase plan (ESPP) which is available to all eligible employees as defined by the plan document. Under the ESPP, shares of the Company’s common stock may be purchased at a discount. The Company estimates the number of shares to be purchased under the ESPP at the beginning of each purchase period based upon the fair value of the stock at the beginning of the purchase period using the Black-Scholes model and records estimated compensation expense during the purchase period. Expense is adjusted at the time of stock purchase.
Use of Estimates—The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including intangible assets, disclosure of
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
The Financial Accounting Standards Board’s (FASB) Accounting Standards Codification (ASC) 820, “Fair Value Measurements and Disclosures” (ASC 820), defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three-levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The Company classifies cash and investments in U.S. government and agency obligations, accounts receivable, short-term other assets, accounts payable and accrued liabilities as Level 1 within the fair value hierarchy. The carrying amounts of these assets and liabilities approximate their fair value due to their relatively short-term nature. Cash equivalents and investments in corporate bonds, commercial paper and asset-backed securities are classified as Level 2 within the fair value hierarchy. The fair value of fixed term debt is estimated by calculating the net present value of future debt payments at current market interest rates and is classified as Level 2. The book value of the Company’s fixed term debt approximates its fair value because the interest rate varies with market rates.
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| Quoted Prices in |
| Significant Other |
| Significant Other |
| Total | ||||
Assets: |
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Money market funds |
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| $ | |
| $ | — |
| $ | |
Commercial paper |
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U.S. government and agency obligations |
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Corporate bonds |
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Asset-backed securities |
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Total assets |
| $ | |
| $ | |
| $ | — |
| $ | |
Liabilities: |
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Contingent consideration |
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Total liabilities |
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| $ | — |
| $ | |
| $ | |
There were no changes in the levels or methodology of measurement of financial assets and liabilities during the three months ended March 31, 2021.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
The following table represents the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2020:
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| Quoted Prices in |
| Significant Other |
| Significant Other |
| Total | ||||
Assets: |
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Money market funds |
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| $ | |
| $ | — |
| $ | |
Commercial paper |
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U.S. government and agency obligations |
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Corporate bonds |
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Asset-backed securities |
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Total assets |
| $ | |
| $ | |
| $ | — |
| $ | |
Liabilities: |
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Contingent consideration |
| $ |
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| $ |
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| $ | |
| $ | |
Total liabilities |
| $ | — |
| $ | — |
| $ | |
| $ | |
Contingent Consideration. The Company has contingent consideration arrangements arising from the SentreHEART acquisition that obligate the Company to pay certain defined amounts to former shareholders of SentreHEART if specified milestones are met related to the aMAZE IDE clinical trial, including PMA approval and reimbursement for the therapy involving SentreHEART’s devices. As of December 31, 2020, the terms of the contingent consideration arrangements under the nContact merger agreement expired.
The Company measures contingent consideration liabilities using unobservable inputs by applying the probability-weighted scenario method, an income approach. Various key assumptions, such as the probability and timing of achievement of the agreed milestones, are used in the determination of fair value of contingent consideration arrangements and are not observable in the market, thus representing a Level 3 measurement within the fair value hierarchy.
The recurring Level 3 fair value measurements of the contingent consideration liabilities include the following significant inputs as of March 31, 2021:
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| Weighted average |
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| Fair Value |
| Valuation Technique |
| Input |
| Range |
|
| by relative fair value |
| |
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|
|
| Probability of payment |
| % |
| % | ||
Regulatory & Reimbursement milestones |
| $ | |
| Probability-weighted scenario approach |
| Projected year of payment |
|
|
| n/a |
| |
|
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|
|
|
|
| Discount rate |
| % |
| % |
Contingent consideration liabilities are periodically measured, with changes in the estimated fair value reflected in selling, general and administrative expenses. Changes in the discount rate, time until payment and probability of payment may result in materially different fair value measurements. A decrease in the discount rate would result in a higher fair value measurement, while a decrease in the probability of payment would result in a lower fair value measurement. Movement in the forecasted timing of achievement to later in the milestone periods would cause a decrease in the fair value measurement. The fair value of the SentreHEART contingent consideration was remeasured as of March 31, 2021 resulting in an increase in fair value due to accretion.
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| Three Months Ended |
|
| Twelve Months Ended | ||
|
| March 31, 2021 |
|
| December 31, 2020 | ||
Beginning Balance |
| $ | |
|
| $ | |
Amounts acquired |
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|
|
Changes in fair value included in earnings |
|
| |
|
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| ( |
Ending Balance |
| $ | |
|
| $ | |
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
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| March 31, 2021 |
| December 31, 2020 | ||||||||
| Estimated Useful Life |
| Cost |
| Accumulated Amortization |
| Cost |
| Accumulated Amortization | ||||
Technology |
| $ | |
| $ | |
| $ | |
| $ | | |
IPR&D |
|
|
| |
|
| — |
|
| |
|
| — |
Total |
|
| $ | |
| $ | |
| $ | |
| $ | |
Amortization expense of intangible assets with definite lives, which excludes the IPR&D assets, was $
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2021 (excluding the three months ended March 31, 2021) |
| $ | |
2022 |
|
| |
2023 |
|
| |
2024 |
|
| |
2025 |
|
| |
2026 and thereafter |
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| |
Total |
| $ | |
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|
| March 31, |
| December 31, | ||
|
| 2021 |
| 2020 | ||
Accrued payroll and employee-related expenses |
| $ | |
| $ | |
Accrued commissions |
|
| |
|
| |
Accrued legal settlement |
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| |
|
| |
Accrued bonus |
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| |
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| |
Sales returns and allowances |
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| |
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| |
Accrued taxes and value-added taxes payable |
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| |
Accrued royalties |
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| |
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| |
Other accrued liabilities |
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| |
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| |
Total |
| $ | |
| $ | |
Credit Facility. The Company has a Loan and Security Agreement (Loan Agreement) with Silicon Valley Bank (SVB), which includes a $
Term loan principal payments commence September 1, 2021. The term loan accrues interest at the greater of the Prime Rate or
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
term loan of $
The revolving line of credit is subject to an annual facility fee of
The Loan Agreement also provides for certain prepayment and early termination fees, as well as establishes a minimum liquidity covenant and dividend restrictions, along with other customary terms and conditions. Specified assets have been pledged as collateral.
Future maturities of long-term debt are projected as follows:
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2021 (excluding the three months ended March 31, 2021) |
| $ | |
2022 |
|
| |
2023 |
|
| |
2024 |
|
| |
Total long-term debt, of which $ |
| $ | |
The Company has operating and finance leases for offices, manufacturing and warehouse facilities and computer equipment. The Company’s leases have remaining lease terms of
The weighted average remaining lease term and the discount rate for the reporting periods is as follows:
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| March 31, 2021 |
| December 31, 2020 |
| ||
Operating Leases |
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Weighted average remaining lease term (years) |
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| ||
Weighted average discount rate |
|
| % |
| % | ||
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Finance leases |
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|
Weighted average remaining lease term (years) |
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| ||
Weighted average discount rate |
|
| % |
| % |
In connection with the terms of the Company’s corporate headquarters lease, a letter of credit for $
The components of lease expense are as follows:
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| Three Months Ended | ||||
|
| March 31, | ||||
|
| 2021 |
| 2020 | ||
Operating lease cost |
| $ | |
| $ | |
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|
Finance lease cost: |
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|
Amortization of right-of-use assets |
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| |
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| |
Interest on lease liabilities |
|
| |
|
| |
Total finance lease cost |
| $ | |
| $ | |
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
Short term lease expense was not significant for the three months ended March 31, 2021 and 2020.
Supplemental cash flow information related to leases was as follows:
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| Three Months Ended |
| Three Months Ended | ||
|
| March 31, 2021 |
| March 31, 2020 | ||
Cash paid for amounts included in the measurement of lease liabilities: |
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|
Operating cash flows from operating leases |
| $ | |
| $ | |
Operating cash flows from finance leases |
|
| |
|
| |
Financing cash flows from finance leases |
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| |
|
| |
Supplemental balance sheet information related to leases was as follows:
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|
| March 31, 2021 |
| December 31, 2020 | ||
Operating Leases |
|
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|
|
Operating lease right-of-use assets |
| $ | |
| $ | |
|
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|
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|
|
|
Other current liabilities and current maturities of debt and leases |
|
| |
|
| |
Operating lease liabilities |
|
| |
|
| |
Total operating lease liabilities |
| $ | |
|
| |
|
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|
|
Finance Leases |
|
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|
|
|
Property and equipment, at cost |
| $ | |
|
| |
Accumulated depreciation |
|
| ( |
|
| ( |
Property and equipment, net |
| $ | |
|
| |
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|
|
Other current liabilities and current maturities of debt and leases |
| $ | |
|
| |
Finance lease liabilities |
|
| |
|
| |
Total finance lease liabilities |
| $ | |
|
| |
Maturities of lease liabilities as of March 31, 2021 were as follows:
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|
|
| Operating Leases |
| Finance Leases | ||
2021 (excluding the three months ended March 31, 2021) | $ | |
| $ | |
2022 |
| |
|
| |
2023 |
| |
|
| |
2024 |
| |
|
| |
2025 |
| |
|
| |
2026 and thereafter |
| — |
|
| |
Total payments | $ | |
| $ | |
Less imputed interest |
| ( |
|
| ( |
Total | $ | |
| $ | |
Royalty Agreements. The Company has royalty agreements in place with terms that include payment of royalties of
Purchase Agreements. The Company enters into standard purchase agreements with certain vendors in the ordinary course of business, generally with terms that allow cancellation.
Legal. The Company may, from time to time, become a party to legal proceedings. Such matters are subject to many uncertainties and to outcomes of which the financial impacts are not predictable with assurance and that may not be known for extended periods of time. When management has assessed that a loss is probable and an amount can be reasonably estimated, the Company records a liability.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
The Company received a Civil Investigative Demand (CID) from the U.S. Department of Justice (USDOJ) in December 2017 stating that it is investigating the Company to determine whether the Company has violated the False Claims Act, relating to the promotion of certain medical devices related to the treatment of atrial fibrillation for off-label use and submitted or caused to be submitted false claims to certain federal and state health care programs for medically unnecessary healthcare services related to the treatment of atrial fibrillation. The CID covers the period from January 2010 to December 2017 and required the production of documents and answers to written interrogatories. The Company had no knowledge of the investigation prior to receipt of the CID. The Company maintains rigorous policies and procedures to promote compliance with the False Claims Act and other applicable regulatory requirements. The Company provided the USDOJ with documents and answers to the written interrogatories. In March 2021, USDOJ informed the Company that its investigation was based on a lawsuit brought under federal and state False Claims Acts, and that the United States and the various states named in the lawsuit were electing not to intervene in the case. USDOJ subsequently filed a Notice of Election to Decline Intervention and to Unseal Complaint, and the case was unsealed. It is not possible to predict when this matter may be resolved or what impact, if any, the outcome of this matter might have on our consolidated financial position, results of operations, or cash flows.
Revenue is generated primarily from the sale of medical devices. The Company recognizes revenue in an amount that reflects the consideration the Company expects to be entitled to in exchange for those devices when control of promised devices is transferred to customers. At contract inception, the Company assesses the products promised in its contracts with customers and identifies a performance obligation for each promise to transfer to the customer a product that is distinct. The Company’s devices are distinct and represent performance obligations. These performance obligations are satisfied, and revenue is recognized at a point in time upon shipment or delivery of products. Sales of devices are categorized as follows: open ablation, minimally invasive ablation, appendage management and valve tools. Shipping and handling activities performed after control over products transfers to customers are considered activities to fulfill the promise to transfer the products rather than as separate promises to customers.
Products are sold primarily through a direct sales force and through distributors in certain international markets. Terms of sale are generally consistent for both end-users and distributors except that payment terms are generally net
Significant judgments and estimates involved in the Company’s recognition of revenue include the estimation of a provision for returns. The Company estimates the provision for sales returns and allowances using the expected value method based on historical experience and other factors that we believe could impact our expected returns, including defective or damaged products and invoice adjustments. In the normal course of business, the Company generally does not accept product returns unless a product is defective as manufactured. The Company does not provide customers with the right to a refund.
The Company expects to be entitled to the total consideration for the products ordered by customers as product pricing is fixed according to the terms of customer contracts and payment terms are short. Payment terms fall within the one-year guidance for the practical expedient which allows the Company to forgo adjustment of the promised amount of consideration for the effects of a significant financing component. The Company excludes taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price.
Costs associated with product sales include commissions and royalties. Considering that product sales are performance obligations in contracts that are satisfied at a point in time, commission expense associated with product sales and royalties paid based on sales of certain products is incurred at that point in time rather than over time. Therefore, the Company applies the practical expedient and recognizes commissions and royalties as expense when incurred because the expense is incurred at a point in time and
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
the amortization period is less than one year. Commissions are recorded as selling expense and royalties are recorded as cost of revenue.
The Company files federal, state, and foreign income tax returns in jurisdictions with varying statutes of limitations. The Company uses the asset and liability method to determine its provision for income taxes. The Company’s provision for income taxes in interim periods is computed by applying the discrete method and is based on financial results through the end of the interim period. The Company determined that using the discrete method is more appropriate than using the annual effective tax rate method. The Company is unable to estimate the annual effective tax rate with sufficient precision to use the effective tax rate method, which requires a full-year projection of income. The effective tax rate for the three months ended March 31, 2021 and 2020 was (
The Company has
Stock Incentive Plan
Under the 2014 Plan, the Board of Directors may grant incentive stock options to Company employees and may grant restricted stock awards or restricted stock units (collectively RSAs), nonstatutory stock options, performance share awards (PSAs) or stock appreciation rights to Company employees, directors and consultants. The administrator (the Compensation Committee of the Board of Directors) has the authority to determine the terms of any awards, including the number of shares subject to each award, the exercisability of the awards and the form of consideration. As of March 31, 2021,
Stock options, restricted stock awards and restricted stock units granted generally vest at a rate of
The award agreements for the PSAs provide that each PSA that vests represents the right to receive
Employee Stock Purchase Plan
The ESPP is available to eligible employees as defined in the plan document. Under the ESPP, shares of the Company’s common stock may be purchased at a discount (
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
purchase a value of more than
Expense Information Under FASB ASC 718
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|
|
|
|
| Three Months Ended | ||||
|
| March 31, | ||||
|
| 2021 |
| 2020 | ||
Cost of revenue |
| $ | |
| $ | |
Research and development expenses |
|
| |
|
| |
Selling, general and administrative expenses |
|
| |
|
| |
Total |
| $ | |
| $ | |
The Company develops, manufactures, and sells devices designed primarily for the surgical ablation of cardiac tissue and systems designed for the exclusion of the left atrial appendage. These devices are developed and marketed to a broad base of medical centers globally. Management considers all such sales to be part of a single operating segment. Revenue attributed to geographic areas, based on the location of customers to whom products are sold, is as follows:
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|
|
|
| Three Months Ended | ||||
|
| March 31, | ||||
|
| 2021 |
| 2020 | ||
United States |
| $ | |
| $ | |
|
|
|
|
|
|
|
Europe |
|
| |
|
| |
Asia |
|
| |
|
| |
Other international |
|
| |
|
| |
Total international |
|
| |
|
| |
Total revenue |
| $ | |
| $ | |
|
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|
|
|
|
|
|
|
|
| Three Months Ended | ||||
|
| March 31, | ||||
|
| 2021 |
| 2020 | ||
Open ablation |
| $ | |
| $ | |
Minimally invasive ablation |
|
| |
|
| |
Appendage management |
|
| |
|
| |
Total ablation and appendage management |
|
| |
|
| |
Valve tools |
|
| |
|
| |
Total United States |
| $ | |
| $ | |
International revenue by product type is as follows:
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|
|
|
|
| Three Months Ended | ||||
|
| March 31, | ||||
|
| 2021 |
| 2020 | ||
Open ablation |
| $ | |
| $ | |
Minimally invasive ablation |
|
| |
|
| |
Appendage management |
|
| |
|
| |
Total ablation and appendage management |
|
| |
|
| |
Valve tools |
|
| |
|
| |
Total international |
| $ | |
| $ | |
The Company’s long-lived assets are located primarily in the United States, except for $
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
(Dollar amounts referenced in this Item 2 are in thousands, except per share amounts.)
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying Condensed Consolidated Financial Statements and notes thereto contained in Item 1 of Part I of this Form 10-Q and our audited financial statements and notes thereto as of and for the year ended December 31, 2020 included in our Form 10-K filed with the Securities and Exchange Commission (SEC) to provide an understanding of our results of operations, financial condition and cash flows.
Forward-Looking Statements
This Form 10-Q, including the sections titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors,” contains forward-looking statements regarding our future performance. 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, including those set forth under “Risk Factors” and elsewhere in this quarterly report on Form 10-Q, and in our annual report on Form 10-K for the year ended December 31, 2020. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Forward-looking statements address our expected future business, financial performance, financial condition and 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 including developments related to the COVID-19 pandemic and PMA approval by FDA on the CONVERGE IDE trial, as discussed herein. 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. These forward-looking statements speak only as of the date of this Form 10-Q. 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.
Overview
We are a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management. Our ablation and left atrial appendage management (LAAM) products are used by physicians during both open-heart and minimally invasive procedures. In open-heart procedures, the physician is performing heart surgery for other conditions and our products are used in conjunction with (“concomitant” to) such a procedure. Minimally invasive procedures are performed on a standalone basis, and often include multi-disciplinary or “hybrid” approaches, combining both surgical procedures using AtriCure ablation and LAAM products and catheter ablation.
We have several product lines for the ablation of cardiac tissue, including our Isolator® Synergy™ Ablation System approved by the United States Food and Drug Administration (FDA) for the treatment of persistent and long-standing persistent forms of Afib concomitant to other open-heart surgical procedures. All of our other ablation devices are approved for sale in the United States under FDA 510(k) clearances, including our other RF and cryoablation products, which are indicated for the ablation of cardiac tissue and/or treatment of cardiac arrhythmias. In addition, certain of our cryoablation probes are cleared for managing pain by temporarily ablating peripheral nerves. Our AtriClip® products are 510(k)-cleared with an indication for the exclusion of the heart’s LAA, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope or other appropriate viewing technologies. The LARIAT® system is cleared for soft tissue ligation. Several of our products are currently being studied to expand labeling claims or support indications specifically for the treatment of Afib. Our Isolator Synergy clamps, Isolator Synergy pens, Coolrail® linear pen, cryoablation devices, certain products of the AtriClip LAA Exclusion System, COBRA Fusion® Ablation System, the EPi-Sense® Guided Coagulation System with VisiTrax® technology, and LARIAT Suture Delivery Device bear the CE mark and may be commercially distributed throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive. Our Isolator Synergy clamps, Isolator Synergy pens, Coolrail linear pen, cryoablation devices and certain products of the AtriClip LAA Exclusion System are available in select Asia-Pacific countries. We anticipate that substantially all of our revenue for the foreseeable future will relate to products we currently sell or are in the process of developing.
We sell our products to medical centers through our direct sales force in the United States and in certain international markets, such as Germany, France, the United Kingdom and the Benelux region. We also sell our products to distributors who in turn sell our
products to medical centers in other international markets. Our business is transacted in U.S. Dollars with the exception of transactions with our European subsidiaries, which are transacted in the Euro or British Pounds.
Recent Developments
We continue to experience uncertainty relating to the challenging and dynamic environment resulting from the COVID-19 pandemic. Throughout 2020 and the beginning of the first quarter of 2021, we experienced a significant decrease in demand for our products as non-emergent procedures were being indeterminately deferred in order to preserve resources for COVID-19 patients and caregivers and to protect patients from potential exposure to COVID-19. While some of our procedures have been insulated from this delay due to an emergent need and we have seen some sign of recovery domestically in 2021, we do not know when the demand for surgical procedures involving our products will be restored back to pre-pandemic levels. The effect of the COVID-19 pandemic on the Company’s business continues to differ by geography and procedure type. We can make no assurance regarding any future level of demand for our products. We expect COVID-19 will continue to adversely impact our results of operations and financial condition as long as decreased demand for our products continues.
We are continuing to serve our customers while taking every precaution to provide a safe work environment for our employees and customers. Most of our office-based employees continue to work remotely, while field-based sales and clinical employees continue to support cases, utilizing technology to engage with customers in virtual settings when physical access is prohibited. We are maintaining manufacturing, assembly, and fulfillment operations to continue providing products to our customers, however, there may be limitations in our ability to continue providing products to our customers in the future. We may have to take further actions that we determine are in the best interests of our employees or as required by federal, state, or local authorities.
Despite the challenging environment resulting from the pandemic, we continue to build on our strategic initiatives of product innovation, investing in clinical science and providing superior training and education. We remain confident in our liquidity position, which includes cash and investments of $236,332 as of March 31, 2021, and access to additional cash through our credit facility.
PRODUCT INNOVATION. We are progressing towards 510(k) clearance of the new ENCOMPASS® clamp and preparing for the subsequent market launch. The ENCOMPASS clamp marks innovation in our core market, and is expected to drive deeper penetration of cardiac surgery procedures.
TRAINING. Our professional education and marketing teams have adapted to the pandemic by conducting online and mobile trainings for our sales team and physicians. These adaptations expanded our training methods and ensured invaluable access to continuing education and awareness of our products and related procedures.
CLINICAL SCIENCE. We continue to invest in studies to expand labeling claims or support indications for the treatment of Afib, and we also conduct various studies to gather clinical data regarding our products. In January 2021, we announced 510(k) clearance of additional labeling claims for cryo nerve block therapy to include the treatment of adolescent patients (12-31 years of age).
Key updates to our major trials:
CONVERGE. In November 2020, we submitted our responses to FDA, seeking PMA approval of the EPi-Sense system for an indication for treatment of symptomatic, drug-refractory, long-standing persistent atrial fibrillation, when augmented with an endocardial ablation catheter. We are currently waiting for feedback from FDA. Once approved, we believe the Convergent procedure will provide the only compelling treatment option for a large and vastly underpenetrated patient population.
aMAZE. Enrollment was completed in December 2019. Patient follow-up for twelve months post pulmonary vein isolation catheter ablation is required by the study protocol and was completed in April 2021. In January 2020, we received approval for a Continued Access Protocol (CAP) for the aMAZE study. The aMAZE CAP provides for additional enrollment of up to 85 patients at existing aMAZE trial sites, with the opportunity to further expand to 250 patients while the PMA application is under review. Enrollment in the aMAZE CAP is ongoing.
We may experience delays in trial enrollment and/or follow-up as a result of the COVID-19 pandemic. We may also encounter interruption or delays in the operations of FDA or other regulatory authorities, which may impact review and approval timelines.
Results of Operations
Three months ended March 31, 2021 compared to three months ended March 31, 2020
The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts and as percentages of revenue:
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| Three Months Ended | ||||||||||
|
| March 31, | ||||||||||
|
| 2021 |
| 2020 | ||||||||
|
| Amount |
| % of |
| Amount |
| % of | ||||
Revenue |
| $ | 59,275 |
| 100.0 | % |
| $ | 53,225 |
| 100.0 | % |
Cost of revenue |
|
| 14,735 |
| 24.9 | % |
|
| 14,341 |
| 26.9 | % |
Gross profit |
|
| 44,540 |
| 75.1 | % |
|
| 38,884 |
| 73.1 | % |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
| 11,217 |
| 18.9 | % |
|
| 11,587 |
| 21.8 | % |
Selling, general and administrative expenses |
|
| 49,208 |
| 83.0 | % |
|
| 42,751 |
| 80.3 | % |
Total operating expenses |
|
| 60,425 |
| 101.9 | % |
|
| 54,338 |
| 102.1 | % |
Loss from operations |
|
| (15,885) |
| (26.8) | % |
|
| (15,454) |
| (29.0) | % |
Other income (expense) |
|
| (1,001) |
| (1.7) | % |
|
| (946) |
| (1.8) | % |
Loss before income tax expense |
|
| (16,886) |
| (28.5) | % |
|
| (16,400) |
| (30.8) | % |
Income tax expense |
|
| 31 |
| 0.1 | % |
|
| 8 |
| 0.0 | % |
Net loss |
| $ | (16,917) |
| (28.5) | % |
| $ | (16,408) |
| (30.8) | % |
Revenue. Revenue increased 11.4% (10.5% on a constant currency basis). Revenue from customers in the United States increased $6,836, or 15.7%, while revenue from international customers decreased $786, or 8.1% (12.9% on a constant currency basis). In the United States, appendage management sales increased $3,168, or 18.2%, attributed to increased volume across AtriClip products. Minimally invasive (MIS) ablation sales increased $1,824, or 27.8%, and open ablation sales increased $1,857, or 9.7%. Growth in our ablation revenue in the United States reflects improved procedural volumes during the quarter, as well as the addition of new accounts. International revenue declined from decreased volume in open and minimally invasive ablation product sales, partially offset by increases in appendage management product sales. International revenue was largely impacted by local COVID restrictions across various geographies.
Revenue reported on a constant currency basis is a non-GAAP measure and is calculated by applying previous period foreign currency (Euro) exchange rates, which are determined by the average daily Euro to Dollar exchange rate, to each of the comparable periods. Revenue is analyzed on a constant currency basis to better measure the comparability of results between periods. Because changes in foreign currency exchange rates have a non-operating impact on revenue, we believe that evaluating revenue growth on a constant currency basis provides additional and meaningful assessment of revenue to both management and our investors.
Cost of revenue and gross margin. Cost of revenue increased $394 reflecting the increase in revenue. Gross margin increased 200 basis points primarily due to both geographic and product mix.
Research and development expenses. Research and development expenses decreased $370, or 3.2%, due to a $940 decrease in clinical trial activities and a $268 decrease in travel expenses. These decreases were partially offset by a $986 increase in personnel and related expenses driven by additional variable compensation.
Selling, general and administrative expenses. Selling, general and administrative expenses increased $6,457, or 15.1%. The increase in selling, general and administrative costs is a result of $6,441 increase in personnel expenses attributable to the increase in headcount and variable compensation, $1,806 increase in share-based compensation expense and $572 increase in legal and professional fees. These increases were partially offset by $1,082 decrease in travel expenses and $1,726 decrease in meetings, trainings and tradeshow expenses as a result of more activities conducted via remote platforms in 2021 than 2020 due to the COVID-19 pandemic.
Other income (expense). Other income and expense consists primarily of net interest expense and foreign currency transaction gains and losses. Net interest expense increased $232 driven by lower interest income from a decline in investment yields.
Liquidity and Capital Resources
As of March 31, 2021, the Company had cash, cash equivalents and investments of $236,332 and outstanding debt of $60,000. We had unused borrowing capacity of $8,750 under our revolving credit facility. Most of our operating cash and all cash equivalents and investments are held by United States financial institutions. We had net working capital of $239,841 and an accumulated deficit of $347,269 as of March 31, 2021.
Cash flows used in operating activities. We used $9,316 of net cash in operating activities during the first quarter of 2021. The net cash outflow from operating activities reflects our net loss of $16,917, offset partially by $12,176 of non-cash expenses, as well as $4,575 net cash used for operating assets and liabilities. Non-cash expenses included $6,604 of share-based compensation, $2,500 increase in the contingent consideration liability and $2,122 of depreciation and amortization. Net cash used for operating assets and liabilities was driven by higher customer receivables from the first quarter increase in revenue and investment in inventories, offset by increases to both accounts payable and accrued liabilities balances, reflecting the increase in inventories and variable compensation balances as of March 31, 2021.
Cash flows provided by investing activities. We generated $63,587 of net cash from investing activities during the three months ended March 31, 2021 reflecting $64,913 of sales and maturities of available-for-sale securities, partially offset by $1,326 of purchases of property and equipment.
Cash flows used in financing activities. We used $10,707 of net cash in financing activities during the three months ended March 31, 2021 from $15,097 for shares repurchased for payment of taxes on stock awards offset by $4,588 of proceeds from stock option exercises.
Credit facility. Our Loan and Security Agreement with Silicon Valley Bank (SVB), as amended, (Loan Agreement), provides for a $60,000 term loan and a $20,000 revolving line of credit. The term loan and revolving credit facility both mature or expire, as applicable, on August 1, 2024. Principal payments on the term loan will commence September 1, 2021 through the loan’s maturity date. The term loan accrues interest at the greater of the Prime Rate or 5.00%, plus 0.75% and is subject to an additional 3.00% fee on the $60,000 term loan principal amount, payable at maturity or upon acceleration or prepayment of the term loan. Our borrowing availability under the revolving credit facility is based on the lesser of $20,000 or a borrowing base calculation as defined by the Loan Agreement. Borrowing availability under the revolving credit facility is further limited by a cap on total debt outstanding under the Loan Agreement, including outstanding letters of credit, of $70,000. As of March 31, 2021, we had no borrowings under the revolving credit facility, and we had borrowing availability of $8,750. The Loan Agreement also provides for certain prepayment and early termination fees if the term loan is repaid before maturity and establishes a minimum liquidity ratio and dividend restrictions, along with other customary terms and conditions. Specified assets have been pledged as collateral.
Our corporate headquarters lease agreement requires a $1,250 letter of credit which renews annually and remains outstanding as of March 31, 2021.
Uses of liquidity and capital resources. Our future capital requirements depend on a number of factors, including market acceptance of our current and future products; the resources we devote to developing and supporting our products; future expenses to support and expand our sales and marketing efforts; costs relating to changes in regulatory policies or laws that affect our operations and cost of filings; costs associated with clinical trials and securing regulatory approval for new products; costs associated with acquiring and integrating businesses; costs associated with prosecuting, defending and enforcing our intellectual property rights; and possible acquisitions and joint ventures. Global economic turmoil, including the impact of the COVID-19 pandemic, has evolved rapidly over the past year and may continue to adversely impact our revenue, thus having an adverse impact on our operating results and financial condition. We continue to evaluate additional measures to maintain financial flexibility, and we will continue to closely monitor our liquidity and capital resources through the disruption caused by COVID-19.
We have on file with the SEC a shelf registration statement which allows us to sell any combination of senior or subordinated debt securities, common stock, preferred stock, warrants, depository shares and units in one or more offerings should we choose to do so in the future. We expect to maintain the effectiveness of this shelf registration statement for the foreseeable future.
We believe that our current cash, cash equivalents and investments, along with the cash we expect to generate or use for operations or access via our revolving line of credit, will be sufficient to meet our anticipated cash needs for working capital and capital expenditures for at least the next twelve months. The SentreHEART acquisition provides for contingent consideration to be paid upon PMA approval before December 2023 and CPT reimbursement before December 2026. Subject to the terms and conditions of the SentreHEART merger agreement, such contingent consideration is expected to be paid primarily in AtriCure common stock, up to a specified maximum number of shares. Over the next twelve months, we do not expect our cash requirements to include significant cash payments for contingent consideration based on progress towards achievement of the related milestones and terms of the acquisition agreement.
If our sources of cash are insufficient to satisfy our liquidity requirements, we may seek to sell additional equity or debt securities or obtain a revised or additional credit facility. The sale of additional equity or convertible debt securities could result in dilution to our stockholders. If additional funds are raised through the issuance of debt securities, these securities could have rights senior to those associated with our common stock and could contain covenants that would restrict our operations. Finally, our term loan agreement and revolving line of credit require compliance with certain financial and other covenants. If we are unable to maintain these financing arrangements, we may be required to reduce the scope of our planned research and development, clinical activities and selling, training, education and marketing efforts.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, revenue and expenses and disclosures of contingent assets and liabilities at the date of the financial statements. On a periodic basis, we evaluate our estimates, including those related to sales returns and allowances, accounts receivable, inventories, intangible assets including goodwill, contingent liabilities and share-based compensation. We use authoritative pronouncements, historical experience and other assumptions as the basis for making estimates. Actual results could differ from those estimates under different assumptions or conditions. Our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 includes additional information about the Company, our operations, our financial position and our critical accounting policies and estimates and should be read in conjunction with this Quarterly Report on Form 10-Q.
Recent Accounting Pronouncements
As of March 31, 2021, there were no material changes to the information provided in Note 2, “Recent Accounting Pronouncements” in the Company’s Form 10-K for the fiscal year ended December 31, 2020.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As of March 31, 2021 there were no material changes to the information provided under Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” in the Company’s Form 10-K for the year ended December 31, 2020.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Company’s management, with the participation of the President and Chief Executive Officer (the Principal Executive Officer) and Chief Financial Officer (the Principal Accounting and Financial Officer), has evaluated the effectiveness of the Company’s disclosure controls and procedures, as defined in Rules 13(a)-15(e) and 15(d) -15(e) of the Securities Exchange Act of 1934 as amended (Exchange Act), as of the end of the period covered by this report. Based on this evaluation, we concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective in providing reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s forms and rules, and the material information relating to the Company is accumulated and communicated to management, including the President and Chief Executive Officer and the Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.
Control systems, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that control objectives are met. Because of inherent limitations in all control systems, no evaluation of controls can provide assurance that all control issues and instances of fraud, if any, within a company will be detected. Additionally, controls can be circumvented by individuals, by collusion of two or more people or by management override. Over time, controls can become inadequate because of changes in conditions or the degree of compliance may deteriorate. Further, the design of any system of controls is based in part upon assumptions about the likelihood of future events. There can be no assurance that any design will succeed in achieving its stated goals under all future conditions. Because of the inherent limitations in any cost-effective control system, misstatements due to errors or fraud may occur and not be detected.
Changes in Internal Control Over Financial Reporting
In the ordinary course of business, we routinely enhance our information systems by either upgrading current systems or implementing new ones. There were no changes in our internal control over financial reporting that occurred during the three months ended March 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Information with respect to legal proceedings can be found under the heading “Legal” in Note 7 – Commitments and Contingencies to the Condensed Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form 10-Q, and is incorporated herein by reference.
Item 1A. Risk Factors
In addition to the other information set forth in this report, careful consideration should be given to the factors discussed in Item 1A, “Risk Factors” in our Form 10-K for the year ended December 31, 2020, all of which could materially affect our business, financial condition or future results. The risks described therein are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, also may adversely affect our business, financial condition and/or operating results. There have been no material changes with respect to the risk factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2020.
Item 6. Exhibits
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|
|
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Exhibit No. | Description |
10.1§ | |
10.2# | |
10.3# | |
31.1 | |
31.2 | |
32.1 | |
32.2 | |
101.INS | XBRL Instance Document |
101.SCH | XBRL Taxonomy Extension Schema Document |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF | XBRL Taxonomy Definition Linkbase Document |
101.LAB | XBRL Taxonomy Extension Label Linkbase Document |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
_________________________
# Compensatory plan or arrangement.
§Certain portions of this exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The omitted information is not material and would likely cause competitive harm to the Registrant if publicly disclosed. The Registrant hereby agrees to furnish a copy of any omitted portion to the SEC upon request.
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, thereunto duly authorized.
|
|
|
|
| AtriCure, Inc. |
| (REGISTRANT) |
|
|
|
|
Date: April 28, 2021 | /s/ Michael H. Carrel |
| Michael H. Carrel |
| President and Chief Executive Officer (Principal Executive Officer) |
|
|
|
|
Date: April 28, 2021 | /s/ Angela L. Wirick |
| Angela L. Wirick |
| Chief Financial Officer (Principal Accounting and Financial Officer) |
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO
SECTION 13(a) OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael H. Carrel, certify that:
1. I have reviewed this quarterly report on Form 10-Q of AtriCure, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. |
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. |
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b. |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: April 28, 2021
|
By: |
/s/ Michael H. Carrel |
|
|
Michael H. Carrel |
|
|
President and Chief Executive Officer |
|
|
(Principal Executive Officer) |
CERTIFICATION OF PRINCIPAL ACCOUNTING AND FINANCIAL OFFICER
PURSUANT TO
SECTION 13(a) OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Angela L. Wirick, certify that:
1. I have reviewed this quarterly report on Form 10-Q of AtriCure, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. |
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. |
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b. |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: April 28, 2021
|
By: |
/s/ Angela L. Wirick |
|
|
Angela L. Wirick |
|
|
Chief Financial Officer |
|
|
(Principal Accounting and Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report of AtriCure, Inc. (Company) on Form 10-Q for the quarter ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (Report), I, Michael H. Carrel, President and Chief Executive Officer and Principal Executive Officer of the Company, certify, pursuant to Rule 13a–14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
1.The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: April 28, 2021
|
By: |
/s/ Michael H. Carrel |
|
|
Michael H. Carrel |
|
|
President and Chief Executive Officer |
|
|
(Principal Executive Officer) |
A signed original of this written statement or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement has been provided to AtriCure, Inc. and will be retained by AtriCure, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) and is not being filed as part of the report or as a separate disclosure document.
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report of AtriCure, Inc. (Company) on Form 10-Q for the quarter ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (Report), I, Angela L. Wirick, Chief Financial Officer and Principal Accounting and Financial Officer of the Company, certify, pursuant to Rule 13a–14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
1.The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: April 28, 2021
|
By: |
/s/ Angela L. Wirick |
|
|
Angela L. Wirick |
|
|
Chief Financial Officer |
|
|
(Principal Accounting and Financial Officer) |
A signed original of this written statement or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement has been provided to AtriCure, Inc. and will be retained by AtriCure, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) and is not being filed as part of the report or as a separate disclosure document.