UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
_____________________________________________
FORM
_____________________________________________
For the quarterly period ended
or
For the transition period from_____________to_____________
Commission File Number
_____________________________________________
(Exact name of Registrant as specified in its charter)
_____________________________________________
|
|
(State or other jurisdiction of incorporation) | (IRS Employer Identification No.) |
(Address of principal executive offices)
(
(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
_____________________________________________
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 (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.
|
|
|
| ||
|
|
|
| ||
x | Accelerated Filer | ¨ | |||
|
|
|
| ||
Non-Accelerated Filer | ¨ | Smaller reporting company |
|
|
|
|
Emerging growth company |
|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act: ¨
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.
|
|
|
|
Class | Outstanding at July 27, 2020 |
Common Stock, $.001 par value |
Table of Contents
|
|
|
|
| Page |
| ||
Item 1. |
| |
| Condensed Consolidated Balance Sheets as of June 30, 2020 and December 31, 2019 | 2 |
| 3 | |
| 4 | |
| Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2020 and 2019 | 5 |
| 6 | |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 20 |
Item 3. | 25 | |
Item 4. | 25 | |
| ||
Item 1. | 26 | |
Item 1A. | 26 | |
Item 5. | 27 | |
Item 6. | 28 | |
29 |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ATRICURE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Per Share Amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| June 30, |
| December 31, | ||
|
| 2020 |
| 2019 | ||
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
| $ | |
| $ | |
Short-term investments |
|
| |
|
| |
Accounts receivable, less allowance for credit losses of $ |
|
| |
|
| |
Inventories |
|
| |
|
| |
Prepaid and other current assets |
|
| |
|
| |
Total current assets |
|
| |
|
| |
Property and equipment, net |
|
| |
|
| |
Operating lease right-of-use assets |
|
| |
|
| |
Long-term investments |
|
| |
|
| |
Intangible assets, net |
|
| |
|
| |
Goodwill |
|
| |
|
| |
Other noncurrent assets |
|
| |
|
| |
Total Assets |
| $ | |
| $ | |
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
| $ | |
| $ | |
Accrued liabilities |
|
| |
|
| |
Other current liabilities and current maturities of long-term debt and leases |
|
| |
|
| |
Total current liabilities |
|
| |
|
| |
Long-term debt |
|
| |
|
| |
Finance lease liabilities |
|
| |
|
| |
Operating lease liabilities |
|
| |
|
| |
Contingent consideration and other noncurrent liabilities |
|
| |
|
| |
Total Liabilities |
|
| |
|
| |
Commitments and contingencies (Note 8) |
|
|
|
| ||
Stockholders’ Equity: |
|
|
|
|
|
|
Common stock, $ outstanding |
|
| |
|
| |
Additional paid-in capital |
|
| |
|
| |
Accumulated other comprehensive loss |
|
| ( |
|
| ( |
Accumulated deficit |
|
| ( |
|
| ( |
Total Stockholders’ Equity |
|
| |
|
| |
Total Liabilities and Stockholders’ Equity |
| $ | |
| $ | |
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended | ||||||||
|
| June 30, |
| June 30, | ||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 | ||||
Revenue |
| $ | |
| $ | |
| $ | |
| $ | |
Cost of revenue |
|
| |
|
| |
|
| |
|
| |
Gross profit |
|
| |
|
| |
|
| |
|
| |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
| |
|
| |
|
| |
|
| |
Selling, general and administrative expenses |
|
| |
|
| |
|
| |
|
| |
Total operating expenses |
|
| |
|
| |
|
| |
|
| |
Loss from operations |
|
| ( |
|
| ( |
|
| ( |
|
| ( |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
| ( |
|
| ( |
|
| ( |
|
| ( |
Interest income |
|
| |
|
| |
|
| |
|
| |
Other |
|
| |
|
| ( |
|
| ( |
|
| ( |
Loss before income tax expense |
|
| ( |
|
| ( |
|
| ( |
|
| ( |
Income tax expense |
|
| |
|
| |
|
| |
|
| |
Net loss |
| $ | ( |
| $ | ( |
| $ | ( |
| $ | ( |
Basic and diluted net loss per share |
| $ | ( |
| $ | ( |
| $ | ( |
| $ | ( |
Weighted average shares outstanding—basic and diluted |
|
| |
|
| |
|
| |
|
| |
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on investments |
| $ | |
| $ | |
| $ | |
| $ | |
Foreign currency translation adjustment |
|
| |
|
| |
|
| ( |
|
| ( |
Other comprehensive income |
|
| |
|
| |
|
| |
|
| |
Net loss |
|
| ( |
|
| ( |
|
| ( |
|
| ( |
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three-Month Period Ended June 30, 2019 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| Accumulated |
|
|
| |
|
|
|
|
|
|
| Additional |
|
|
|
| Other |
| Total | |||
|
| Common Stock |
| Paid-in |
| Accumulated |
| Comprehensive |
| Stockholders’ | |||||||
|
| Shares |
| Amount |
| Capital |
| Deficit |
| Income (Loss) |
| Equity | |||||
Balance—March 31, 2019 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Impact of equity compensation plans |
| |
|
|
|
|
| |
|
|
|
|
|
|
|
| |
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
| |
Net loss |
|
|
|
|
|
|
|
|
|
| ( |
|
|
|
|
| ( |
Balance—June 30, 2019 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three-Month Period Ended June 30, 2020 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| Accumulated |
|
|
| |
|
|
|
|
|
|
| Additional |
|
|
|
| Other |
| Total | |||
|
| Common Stock |
| Paid-in |
| Accumulated |
| Comprehensive |
| Stockholders’ | |||||||
|
| Shares |
| Amount |
| Capital |
| Deficit |
| Income (Loss) |
| Equity | |||||
Balance—March 31, 2020 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Issuance of common stock through public offering |
| |
|
| |
|
| |
|
|
|
|
|
|
|
| |
Impact of equity compensation plans |
| |
|
|
|
|
| |
|
|
|
|
|
|
|
| |
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
| |
Net loss |
|
|
|
|
|
|
|
|
|
| ( |
|
|
|
|
| ( |
Balance—June 30, 2020 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Six-Month Period Ended June 30, 2019 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| Accumulated |
|
|
| |
|
|
|
|
|
|
| Additional |
|
|
|
| Other |
| Total | |||
|
| Common Stock |
| Paid-in |
| Accumulated |
| Comprehensive |
| Stockholders’ | |||||||
|
| Shares |
| Amount |
| Capital |
| Deficit |
| Income (Loss) |
| Equity | |||||
Balance—December 31, 2018 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Impact of equity compensation plans |
| |
|
|
|
|
| |
|
|
|
|
|
|
|
| |
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
| |
Net loss |
|
|
|
|
|
|
|
|
|
| ( |
|
|
|
|
| ( |
Balance—June 30, 2019 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Six-Month Period Ended June 30, 2020 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| Accumulated |
|
|
| |
|
|
|
|
|
|
| Additional |
|
|
|
| Other |
| Total | |||
|
| Common Stock |
| Paid-in |
| Accumulated |
| Comprehensive |
| Stockholders’ | |||||||
|
| Shares |
| Amount |
| Capital |
| Deficit |
| Income (Loss) |
| Equity | |||||
Balance—December 31, 2019 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Issuance of common stock through public offering |
| |
|
| |
|
| |
|
|
|
|
|
|
|
| |
Impact of equity compensation plans |
| |
|
|
|
|
| |
|
|
|
|
|
|
|
| |
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
| |
Net loss |
|
|
|
|
|
|
|
|
|
| ( |
|
|
|
|
| ( |
Balance—June 30, 2020 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
See accompanying notes to condensed consolidated financial statements.
ATRICURE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Six Months Ended | ||||
|
|
| June 30, | ||||
|
|
| 2020 |
| 2019 | ||
Cash flows from operating activities: |
|
|
|
|
|
|
|
Net loss |
|
| $ | ( |
| $ | ( |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
| |
|
| |
Depreciation |
|
|
| |
|
| |
Amortization of intangible assets |
|
|
| |
|
| |
Amortization of deferred financing costs |
|
|
| |
|
| |
Loss on disposal of property and equipment |
|
|
| |
|
| |
Amortization (accretion) of investments |
|
|
| |
|
| ( |
Change in value of contingent consideration |
|
|
| ( |
|
| ( |
Other non-cash adjustments to income |
|
|
| |
|
| |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Accounts receivable |
|
|
| |
|
| ( |
Inventories |
|
|
| ( |
|
| ( |
Other current assets |
|
|
| ( |
|
| ( |
Accounts payable |
|
|
| ( |
|
| |
Accrued liabilities |
|
|
| ( |
|
| ( |
Other noncurrent assets and liabilities |
|
|
| |
|
| ( |
Net cash used in operating activities |
|
|
| ( |
|
| ( |
Cash flows from investing activities: |
|
|
|
|
|
|
|
Purchases of available-for-sale securities |
|
|
| ( |
|
| ( |
Sales and maturities of available-for-sale securities |
|
|
| |
|
| |
Purchases of property and equipment |
|
|
| ( |
|
| ( |
Proceeds from sale of property and equipment |
|
|
|
|
|
| |
Proceeds from capital grant |
|
|
| |
|
|
|
Net cash (used in) provided by investing activities |
|
|
| ( |
|
| |
Cash flows from financing activities: |
|
|
|
|
|
|
|
Proceeds from sale of stock, net of offering costs of $ |
|
|
| |
|
|
|
Payments on debt and leases |
|
|
| ( |
|
| ( |
Payments of debt fees |
|
|
| ( |
|
| ( |
Proceeds from stock option exercises and employee stock purchase plan |
|
|
| |
|
| |
Shares repurchased for payment of taxes on stock awards |
|
|
| ( |
|
| ( |
Net cash provided by (used in) financing activities |
|
|
| |
|
| ( |
Effect of exchange rate changes on cash and cash equivalents |
|
|
| ( |
|
| ( |
Net increase (decrease) in cash and cash equivalents |
|
|
| |
|
| ( |
Cash and cash equivalents—beginning of period |
|
|
| |
|
| |
Cash and cash equivalents—end of period |
|
| $ | |
| $ | |
Supplemental cash flow information: |
|
|
|
|
|
|
|
Cash paid for interest |
|
| $ | |
| $ | |
Cash paid for income taxes |
|
|
| |
|
| |
Non-cash investing and financing activities: |
|
|
|
|
|
|
|
Accrued purchases of property and equipment |
|
|
| |
|
| |
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)
1. DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| June 30, |
| December 31, | ||
|
| 2020 |
| 2019 | ||
Raw materials |
| $ | |
| $ | |
Work in process |
|
| |
|
| |
Finished goods |
|
| |
|
| |
Inventories |
| $ | |
| $ | |
Property and Equipment—Property and equipment is stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of assets. The estimated useful life by major asset category is the following:
|
|
|
|
| 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 recorded by the Company have not been significant.
Leases—The Company determines if an arrangement is a lease at inception of the contract. The Company applies the short-term lease recognition exemption, recognizing lease payments in profit or loss for leases that have a lease term of 12 months or less at commencement and do not include a purchase option whose exercise is reasonably certain. Operating leases are included in operating lease right-of-use (ROU) assets, other current liabilities and current maturities of leases and long-term debt, and operating lease liabilities. Finance leases are included in property and equipment, other current liabilities and current maturities of leases and long-term debt, and finance lease liabilities.
Intangible Assets—Intangible assets with determinable useful lives are amortized on a straight-line basis over the estimated periods benefited. Intangible assets include In Process Research and Development (IPR&D), representing the value of technology acquired in business combinations that has not yet reached technological feasibility. The primary basis for determining technological feasibility is obtaining specific regulatory approvals. IPR&D is accounted for as an indefinite-lived intangible asset until completion
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
or abandonment of the IPR&D project. Upon completion of the development project, IPR&D will be amortized over its estimated useful life. The IPR&D assets represent an estimate of the fair value of the pre-market approval (PMA) that could result from the aMAZETM and CONVERGE IDE clinical trials. If the IPR&D projects are abandoned or regulatory approvals are not obtained, 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.
Other Income (Expense)—Other income (expense) consists primarily of foreign currency transaction gains and losses generated by settlements of intercompany balances denominated in Euros and customer invoices transacted in British Pounds.
Taxes—Deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred income tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred income tax assets and liabilities from a change in tax rates is recognized in the period that includes the enactment date.
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 reversals of existing taxable temporary differences, future taxable income, exclusive of reversing temporary differences and 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 the 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended | ||||||||
|
| June 30, |
| June 30, | ||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 | ||||
Total accumulated other comprehensive loss at beginning of period |
| $ | ( |
| $ | ( |
| $ | ( |
| $ | ( |
Unrealized Gains (Losses) on Investments |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at beginning of period |
| $ | |
| $ | |
| $ | |
| $ | ( |
Other comprehensive income before reclassifications |
|
| |
|
| |
|
| |
|
| |
Amounts reclassified from accumulated other comprehensive loss to other income (expense) |
|
|
|
|
|
|
|
| |
|
|
|
Balance at end of period |
| $ | |
| $ | |
| $ | |
| $ | |
Foreign Currency Translation Adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at beginning of period |
| $ | ( |
| $ | ( |
| $ | ( |
| $ | ( |
Other comprehensive income (loss) before reclassifications |
|
| |
|
| |
|
| ( |
|
| ( |
Amounts reclassified from accumulated other comprehensive loss to other income (expense) |
|
| ( |
|
| |
|
| |
|
| |
Balance at end of period |
| $ | ( |
| $ | ( |
| $ | ( |
| $ | ( |
Total accumulated other comprehensive loss at end of period |
| $ | ( |
| $ | ( |
| $ | ( |
| $ | ( |
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 value of the portion of the awards that is ultimately expected to vest is recognized as expense over the requisite service periods. The Company estimates the fair value of restricted stock awards, restricted stock units and performance share awards based upon the grant date closing market price of the Company’s common stock. The estimated fair value of performance share awards may be adjusted over the performance period based on changes to estimates of performance target achievement.
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.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
In June 2016, the FASB issued Accounting Standard Update (ASU )2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (ASU 2016-13). This guidance requires that financial assets measured at amortized costs, such as trade receivables and contract assets, be presented net of expected credit losses, which may be estimated based on relevant information such as historical experience, current conditions and future expectations for each pool of similar financial assets. The Company has applied the new requirements by calculating and recording an allowance for credit losses on trade receivables as of January 1, 2020. As a result of the adoption, the Company adjusted its allowance for credit losses on trade receivables; however the adjustment did not have a material impact on its consolidated financial statements and related disclosures.
In January 2017, the FASB issued ASU 2017-04, “Intangibles – Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment” (ASU 2017-04). The guidance removes the requirement to perform a hypothetical purchase price allocation to measure goodwill impairment. Under ASU 2017-04, a goodwill impairment will be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. The guidance becomes effective for annual reporting periods beginning after December 15, 2019 and interim periods within those fiscal years, with early adoption permitted, and applied prospectively. The Company has adopted this guidance as of January 1, 2020, and the adoption of this standard did not have a material impact on its consolidated financial statements and related disclosures.
Fair value is defined 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 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 agencies and securities, 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, repurchase agreements 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.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Quoted Prices in |
| Significant Other |
| Significant Other |
| Total | ||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
| $ | — |
| $ | |
| $ | — |
| $ | |
Commercial paper |
|
| — |
|
| |
|
| — |
|
| |
U.S. government agencies and securities |
|
| |
|
| — |
|
| — |
|
| |
Corporate bonds |
|
| — |
|
| |
|
| — |
|
| |
Asset-backed securities |
|
| — |
|
| |
|
| — |
|
| |
Total assets |
| $ | |
| $ | |
| $ | — |
| $ | |
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration |
|
| — |
|
| — |
|
| |
|
| |
Total liabilities |
| $ | — |
| $ | — |
| $ | |
| $ | |
There were no changes in the levels or methodology of measurement of financial assets and liabilities during the three and six months ended June 30, 2020.
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, 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Quoted Prices in |
| Significant Other |
| Significant Other |
| Total | ||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
| $ | — |
| $ | |
| $ | — |
| $ | |
Repurchase agreements |
|
| — |
|
| |
|
| — |
|
| |
Commercial paper |
|
| — |
|
| |
|
| — |
|
| |
U.S. government agencies and securities |
|
| |
|
| — |
|
| — |
|
| |
Corporate bonds |
|
| — |
|
| |
|
| — |
|
| |
Asset-backed securities |
|
| — |
|
| |
|
| — |
|
| |
Total assets |
| $ | |
| $ | |
| $ | — |
| $ | |
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration |
|
|
|
|
|
|
|
| |
|
| |
Total liabilities |
| $ | — |
| $ | — |
| $ | |
| $ | |
Contingent Consideration. The Company has contingent consideration arrangements arising from the nContact and SentreHEART acquisitions. Contingent consideration arrangements with the former shareholders of nContact obligate the Company to pay certain defined amounts to former shareholders of nContact if PMA approval from the CONVERGE IDE trial is received within specified timelines. Contingent consideration arrangements under the SentreHEART merger agreement 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.
The Company measures contingent consideration liabilities using unobservable inputs by applying an income approach, such as the probability-weighted scenario method. Key assumptions, such as the probability and timeline 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.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
The recurring Level 3 fair value measurements of the contingent consideration liabilities include the following significant inputs as of June 30, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average |
|
|
| Fair Value |
| Valuation Technique |
| Unobservable Input |
| Range |
|
| by relative fair value |
| |
|
|
|
|
|
|
| Discount rate |
| % |
| % | ||
Regulatory & Commercialization-based milestones |
| $ | |
| Probability-weighted scenario approach |
| Projected month and year of payment |
|
|
| n/a |
| |
|
|
|
|
|
|
| Probability of payment |
| % |
| % |
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 also causes a decrease in the fair value measurement. The fair value of the contingent consideration was remeasured as of June 30, 2020 resulting in a net decrease in fair value due to movement in the forecasted timing of achievement to later in the milestone period, partially offset by an increase in fair value due to accretion.
The following table represents the Company’s Level 3 fair value measurements using significant other unobservable inputs for acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Six Months Ended |
|
| Twelve Months Ended | ||
|
| June 30, 2020 |
|
| December 31, 2019 | ||
Beginning Balance |
| $ | |
|
| $ | |
Amounts acquired |
|
|
|
|
|
| |
Changes in fair value included in earnings |
|
| ( |
|
|
| ( |
Ending Balance |
| $ | |
|
| $ | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| June 30, 2020 |
| December 31, 2019 | ||||||||
| Estimated Useful Life |
| Cost |
| Accumulated Amortization |
| Cost |
| Accumulated Amortization | ||||
Technology |
| $ | |
| $ | |
| $ | |
| $ | | |
IPR&D |
|
|
| |
|
| — |
|
| |
|
| — |
Total |
|
| $ | |
| $ | |
| $ | |
| $ | |
Amortization expense of intangible assets with definite lives was $
|
|
|
|
|
|
|
|
2020 (excluding the six months ended June 30, 2020) |
| $ | |
2021 |
|
| |
2022 |
|
| |
2023 |
|
| |
2024 |
|
| |
2025 and thereafter |
|
| |
Total |
| $ | |
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
The following table provides a summary of the Company’s goodwill, which is not amortized, but rather is tested annually for impairment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Six Months Ended |
| Twelve Months Ended | ||
|
| June 30, 2020 |
| December 31, 2019 | ||
Beginning Balance |
| $ | |
| $ | |
Amounts acquired |
|
|
|
|
| |
Ending Balance |
| $ | |
| $ | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| June 30, |
| December 31, | ||
|
| 2020 |
| 2019 | ||
Accrued payroll and employee-related expenses |
| $ | |
| $ | |
Sales returns and allowances |
|
| |
|
| |
Accrued commissions |
|
| |
|
| |
Accrued bonus |
|
| |
|
| |
Accrued taxes and value-added taxes payable |
|
| |
|
| |
Accrued royalties |
|
| |
|
| |
Other accrued liabilities |
|
| |
|
| |
Total |
| $ | |
| $ | |
Credit Facility. The Company has a Loan and Security Agreement (Loan Agreement) with Silicon Valley Bank (SVB), which includes a $
Principal payments of the term loan are to be made ratably commencing March 1, 2021 through the loan’s maturity date. If the Company meets certain conditions, as specified by the Loan Agreement, the commencement of term loan principal payments may be deferred by an additional
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.
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
Future maturities of long-term debt are projected as follows:
|
|
|
|
|
|
|
|
2020 (excluding the six months ended June 30, 2020) |
| $ | — |
2021 |
|
| |
2022 |
|
| |
2023 |
|
| |
2024 |
|
| |
Total long-term debt, of which $ |
| $ | |
The Company has operating and finance leases for corporate office and warehouse facilities and computer equipment. The Company applies the practical expedient under ASU 2018-11, “Leases (Topic 842): Targeted Improvements” and does not separate lease components from nonlease components. The Company also applies the short-term lease recognition exemption and recognizes lease payments in profit or loss related to contracts that have a lease term of twelve months or less at commencement and do not include a renewal option whose exercise is reasonably certain. Short term lease expense was not significant for the three and six months ended June 30, 2020 and 2019.
The Company’s leases have remaining lease terms of
The weighted average remaining lease term and incremental borrowing rates for the reporting periods are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| June 30, 2020 |
| December 31, 2019 |
| ||
Operating Leases |
|
|
|
|
|
|
|
Weighted average remaining lease term (years) |
|
|
|
|
| ||
Weighted average discount rate |
|
| % |
| % | ||
|
|
|
|
|
|
|
|
Finance leases |
|
|
|
|
|
|
|
Weighted average remaining lease term (years) |
|
|
|
|
| ||
Weighted average discount rate |
|
| % |
| % |
In connection with the terms of the Company’s corporate headquarters lease, a letter of credit in the amount of $
The components of lease expense were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Three Months Ended |
| Six Months Ended |
| Six Months Ended | ||||
|
| June 30, 2020 |
| June 30, 2019 |
| June 30, 2020 |
| June 30, 2019 | ||||
Operating lease cost |
| $ | |
| $ | |
| $ | |
| $ | |
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance lease cost: |
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of right-of-use assets |
|
| |
|
| |
|
| |
|
| |
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)
Supplemental cash flow information related to leases was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Six Months Ended |
| Six Months Ended | ||
|
| June 30, 2020 |
| June 30, 2019 | ||
Cash paid for amounts included in the measurement of lease liabilities: |
|
|
|
|
|
|
Operating cash flows from operating leases |
| $ |
| $ | ||
Operating cash flows from finance leases |
|
|
|
| ||
Financing cash flows from finance leases |
|
|
|
| ||
|
|
|
|
|
|
|
Right-of-use assets obtained in exchange for lease obligations: |
|
|
|
|
|
|
Operating Leases |
|
| |
|
| |
Finance Leases |
|
| — |
|
| — |
Early termination of operating lease |
|
| |
|
| — |
Supplemental balance sheet information related to leases was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| June 30, 2020 |
| December 31, 2019 | ||
Operating Leases |
|
|
|
|
|
|
Operating lease right-of-use assets |
| $ | |
| $ | |
|
|
|
|
|
|
|
Other current liabilities and current maturities of leases and long-term debt |
|
| ( |
|
| ( |
Operating lease liabilities |
|
| ( |
|
| ( |
Total operating lease liabilities |
| $ | ( |
|
| ( |
|
|
|
|
|
|
|
Finance Leases |
|
|
|
|
|
|
Property and equipment, at cost |
| $ | |
|
| |
Accumulated depreciation |
|
| ( |
|
| ( |
Property and equipment, net |
| $ | |
|
| |
|
|
|
|
|
|
|
Other current liabilities and current maturities of leases and long-term debt |
| $ | ( |
|
| ( |
Finance lease liabilities |
|
| ( |
|
| ( |
Total finance lease liabilities |
| $ | ( |
|
| ( |
Maturities of lease liabilities as of June 30, 2020 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
| Operating Leases |
| Finance Leases | ||
2020 (excluding the six months ended June 30, 2020) | $ | |
| $ | |
2021 |
| |
|
| |
2022 |
| |
|
| |
2023 |
| |
|
| |
2024 |
| |
|
| |
2025 and thereafter |
| |
|
| |
Total payments | $ | |
| $ | |
Less imputed interest |
| ( |
|
| ( |
Total | $ | |
| $ | |
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
Royalty Agreements. The Company has certain 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.
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 requires 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 and is cooperating with its investigation. However, the Company cannot predict when the investigation will be resolved, the outcome of the investigation or its potential impact on the Company.
The Company acquired nContact Surgical, Inc. pursuant to a merger agreement dated October 4, 2015. The merger agreement provides for contingent consideration or “earnout” to be paid upon attaining specified regulatory approvals and clinical and revenue milestones. The merger agreement’s earnout provisions require the Company to deliver periodic earnout reports to a designated representative of former nContact stockholders. In response to the reports delivered in and after February 2018, the Company received letters from representatives purporting to serve as “earnout objection statements” (as that term is defined in the merger agreement) and claim that for purposes of determining the commercial milestone payment, the Company should be including revenues of certain additional items and products that the Company has not included in its earnout statements. The representative is seeking indemnification under the merger agreement related to its claims. The Company has engaged with the representative regarding the earnout objection statements and disputes the basis of the representative’s claims. The Company has not recorded an expense related to the outcome of this claim because it is not yet possible to determine if a potential loss is probable or reasonably estimable.
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 (MIS), 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 select international markets. Terms of sale are generally consistent for both end-users and distributors except that payment terms are generally net 30 days for end-users and net 60 days for distributors, with limited exceptions. The Company does not maintain any post-shipping obligations to customers. No installation, calibration or testing of products is performed by the Company subsequent to shipment in order to render products operational.
Significant judgments and estimates involved in the Company’s recognition of revenue include the determination of the timing of transfer of control of products to customers and the estimation for the provision for returns. The Company considers the following
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
indicators when determining when the control of products transfers to customers: (i) the Company has a right to payment in accordance with the shipping terms set forth in its contracts with customers; (ii) customers have legal title to products in accordance with shipping terms; (iii) the Company transfers physical possession of products either when the Company presents the products to a third party carrier for delivery to a customer (FOB shipping point) or when a customer receives the delivered goods (FOB destination); (iv) customers have the significant risks and rewards of ownership of products; and (v) customers have accepted products in connection with contractual shipping terms.
In the normal course of business, the Company does not accept product returns unless a product is defective as manufactured. The Company establishes estimated provisions for returns based on historical experience. The Company does not provide customers with the right to a refund. In connection with the acquisition of SentreHEART in 2019, the Company recognized an allowance for sales returns and refunds of $
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 the amortization period is less than one year. Commissions are recorded as selling expense and royalties are recorded as cost of revenue.
See Note 12 for disaggregated revenue by geographic area and by product category.
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 for the period ended June 30, 2020 was estimated using the discrete method and was based on our financial results through the end of the period. We are unable to estimate the annual effective tax rate with sufficient precision for purposes of the effective tax rate method, which requires us to consider a projection of full-year income. As a result, we determined that using the discrete method is more appropriate than using the annual effective tax rate method. The effective tax rate for the three months ended June 30, 2020 and 2019 was (
Federal, state and local returns of the Company are routinely subject to review by various taxing authorities. The Company has not accrued any interest and penalties related to unrecognized income tax benefits as a result of offsetting of net operating losses. However, if the situation occurs, the Company will recognize interest and penalties within income tax expense and within the related tax liability.
The Company has
Stock Incentive Plan
Under the 2014 Plan, the Board of Directors may grant incentive stock options to employees and may grant restricted stock, restricted stock units, (collectively RSAs), nonstatutory stock options, performance share awards (PSAs) or stock appreciation rights to employees, directors and consultants. As administrator of the 2014 Plan, 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 June 30, 2020,
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
2014 Plan, and
The Compensation Committee approved the grant of performance share awards to the Company’s named executive officers and certain other employees pursuant to the 2014 Plan. The form of award agreement for the PSAs (PSA Grant Form) provides, among other things, that (i) each PSA that vests represents the right to receive
With respect to the PSAs, the number of shares that vest and are issued to the recipient is based upon the Company’s performance as measured against the specified targets at the end of the three-year performance period as determined by the Compensation Committee. The Company estimates the fair value of the PSAs based on its closing stock price on the grant date and will adjust compensation expense over the performance period based on its estimate of performance target achievement.
Stock options, restricted stock awards and restricted stock units granted generally vest at a rate of
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 (
Expense Information Under FASB ASC 718
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended | ||||||||
|
| June 30, |
| June 30, | ||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 | ||||
Cost of revenue |
| $ | |
| $ | |
| $ | |
| $ | |
Research and development expenses |
|
| |
|
| |
|
| |
|
| |
Selling, general and administrative expenses |
|
| |
|
| |
|
| |
|
| |
Total |
| $ | |
| $ | |
| $ | |
| $ | |
ATRICURE, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In Thousands, except per share amounts)
(Unaudited)
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, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended | ||||||||
|
| June 30, |
| June 30, | ||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 | ||||
United States |
| $ | |
| $ | |
| $ | |
| $ | |
|
|
|
|
|
|
|
|
|
|
|
|
|
Europe |
|
| |
|
| |
|
| |
|
| |
Asia |
|
| |
|
| |
|
| |
|
| |
Other international |
|
| |
|
| |
|
| |
|
| |
Total international |
|
| |
|
| |
|
| |
|
| |
Total revenue |
| $ | |
| $ | |
| $ | |
| $ | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended | ||||||||
|
| June 30, |
| June 30, | ||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 | ||||
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended | ||||||||
|
| June 30, |
| June 30, | ||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 | ||||
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 and share 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, 2019 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, 2019. 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. 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. We have several product lines for the ablation of cardiac tissue, including our Isolator® Synergy™ Ablation System, the first and only surgical device approved by the United States Food and Drug Administration (FDA) for the treatment of persistent and long-standing persistent forms of Afib in patients undergoing certain open concomitant procedures. We also offer a variety of minimally invasive ablation devices and access tools to facilitate the growing trend in less invasive cardiac and thoracic surgery. Our cryoICE® cryosurgery product line offers a variety of cryoablation devices for use in multiple types of cardiothoracic surgery, and our AtriClip® LAA Exclusion System is a device specifically designed to exclude the heart’s left atrial appendage.
Our products are used by physicians during both open-heart and minimally invasive procedures, either in conjunction with heart surgery for other conditions (“concomitant” to such a procedure) or on a standalone basis. Our Isolator Synergy System is approved by FDA for the treatment of persistent and long-standing persistent 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 and is currently being studied to support an indication of exclusion of the LAA in patients with persistent and long-standing persistent Afib also undergoing a pulmonary vein isolation. We also offer reusable surgical instruments typically used for cardiac valve replacement or repair. Our Isolator Synergy clamps, Isolator Synergy pens, Coolrail® linear pen, cryosurgery devices, certain products of the AtriClip LAA Exclusion System, COBRA Fusion® Ablation System, and 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, cryosurgery 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 Euros or British Pounds.
Recent Developments
COVID-19 Pandemic
The challenging environment resulting from the COVID-19 pandemic is adversely impacting our 2020 results of operations and financial condition. Beginning in the first quarter of 2020, we have experienced a significant decrease in demand for our products as non-emergent procedures are 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 may be insulated from this delay due to an emergent need, the variability is too great to allow us to measure the true impact of this disruption to our business. At the end of the second quarter of 2020, we began to see some hospitals restarting emergent and elective procedures, however, we do not know when the demand for surgical procedures involving our products will be restored back to pre-COVID-19 levels, and we can make no assurance regarding any future level of demand for our products. Therefore, we expect the COVID-19 pandemic will continue to adversely impact our results of operations and financial condition as long as decreased demand for our products continues. We may experience delays in trial enrollment and trial 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. To date, we have not experienced any significant COVID-19 related supply chain challenges, however, we may be affected in the future.
In response to the COVID-19 pandemic, we have implemented a number of measures to provide a safe work environment for our employees and customers. Most of our office-based employees began working remotely in March 2020, while field-based sales and clinical employees are continuing to support cases, utilizing technology to engage with customers in virtual settings when physical access is prohibited. We are also maintaining manufacturing, assembly, and fulfillment operations, to continue providing products to our customers, however, there may be limitations in our ability to continue such operations in the future. Throughout the second quarter of 2020, we temporarily reduced production capacity and may implement similar reductions in the future. We have modified our manufacturing operations in order to adhere to social distancing requirements dictated by local law and have taken measures to help ensure safety, including requiring temperature checks for employees entering our facilities. 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.
We have adjusted our operating plan and expect to continuously evaluate and as may be necessary, amend our operating plan as a result of the COVID-19 pandemic. We have proactively delayed certain capital investments and hiring, and have implemented other expense-reduction measures, including ceasing non-essential travel and conference activity and suspending work on certain research and development projects. Adjustments to the operating plan have not included temporary or permanent reductions in headcount or to non-executive employee compensation. However, we are unable to ensure the operating plan adjustments we have made will be sufficient or sustained due to the inherent uncertainty of the unprecedented and rapidly evolving situation. Additionally, we have taken measures to bolster our capital structure and liquidity. On April 29, 2020, we entered into an amendment to our Loan Agreement to modify a covenant related to the Company’s liquidity ratio through the third quarter 2020 testing date. Subsequent to the amendment, we further strengthened our liquidity position through a public offering and sale of our common stock. In May 2020, we conducted an underwritten public offering of 3,977 shares of common stock, and provided the underwriters a 30-day option to purchase up to 597 additional shares of common stock. Upon closing of the offering, we issued 4,574 shares of common stock and received net proceeds of $188,958.
Clinical Trials
We are conducting several clinical trials to validate the long-term results of procedures using our products and to support applications to regulatory agencies for expanded indications. In addition, we also conduct various studies to gather clinical data regarding our products. Key updates to our major trials include:
CONVERGE. In April 2020, we conducted an initial meeting with FDA following our pre-market approval (PMA) submission in December 2019. We presented the results from the CONVERGE IDE trial as part of the Late-Breaking Clinical Trial sessions at the Heart Rhythm Society Annual Scientific Session in May 2020. We continue to actively work with FDA to complete the regulatory process.
aMAZE. Enrollment was completed in December 2019. Patient follow-up for twelve months post treatment is required by the study protocol and remains ongoing. At this time, we have not experienced a significant delay in patient follow-up. However, we are unable to predict the occurrence of future delays as a result of the COVID-19 pandemic. 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 pre-market application is under review. Enrollment in the CAP for the aMAZE study is active and remains ongoing.
Results of Operations
Three months ended June 30, 2020 compared to three months ended June 30, 2019
The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts and as percentages of revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended | ||||||||||
|
| June 30, | ||||||||||
|
| 2020 |
| 2019 | ||||||||
|
| Amount |
| % of |
| Amount |
| % of | ||||
Revenue |
| $ | 40,824 |
| 100.0 | % |
| $ | 58,906 |
| 100.0 | % |
Cost of revenue |
|
| 13,170 |
| 32.3 | % |
|
| 15,013 |
| 25.5 | % |
Gross profit |
|
| 27,654 |
| 67.7 | % |
|
| 43,893 |
| 74.5 | % |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
| 10,036 |
| 24.6 | % |
|
| 9,804 |
| 16.6 | % |
Selling, general and administrative expenses |
|
| 24,903 |
| 61.0 | % |
|
| 37,928 |
| 64.4 | % |
Total operating expenses |
|
| 34,939 |
| 85.6 | % |
|
| 47,732 |
| 81.0 | % |
Loss from operations |
|
| (7,285) |
| (17.8) | % |
|
| (3,839) |
| (6.5) | % |
Other income (expense) |
|
| (939) |
| (2.3) | % |
|
| (252) |
| (0.4) | % |
Loss before income tax expense |
|
| (8,224) |
| (20.1) | % |
|
| (4,091) |
| (6.9) | % |
Income tax expense |
|
| 12 |
| 0.0 | % |
|
| 10 |
| 0.0 | % |
Net loss |
| $ | (8,236) |
| (20.2) | % |
| $ | (4,101) |
| (7.0) | % |
Revenue. Revenue decreased 30.7% (30.6% on a constant currency basis) due to the global decline in surgical procedures as healthcare providers limited activity not related to addressing the COVID-19 pandemic. Revenue from customers in the United States decreased $13,501, or 28.6%, and revenue from international customers decreased $4,581, or 39.0% (38.5% on a constant currency basis). In the United States, open ablation and appendage management products experienced a slightly lower decline in sales than minimally invasive (MIS) ablation due to the inherent ability to defer MIS procedures. Open ablation sales declined $5,011 (24.4%,) and appendage management sales decreased $3,477 (21.1%), while MIS ablation sales decreased $4,337 (47.7%). International revenue declined from reduced volume across all product types and countries.
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 decreased $1,843, driven primarily by the reduction of sales as a result of the COVID-19 pandemic. Throughout the three months ended June 30, 2020, production volumes were reduced below our normal operating levels, leading to an increase in fixed costs burdened to cost of revenue, decreasing gross margin 6.8%.
Research and development expenses. Research and development expenses increased $232 due to $1,621 incremental costs for SentreHEART research and development activities, including $603 of product development project activities, $541 of personnel expenses and $328 in clinical activities for the aMAZE trial. These increases were offset by a $1,389 decrease in legacy research and development operations, including $643 lower personnel costs due to decline in variable compensation and travel and $615 lower clinical and scientific affairs expenses due to lower enrollment in clinical trials in 2020.
Selling, general and administrative expenses. Selling, general and administrative expenses decreased $13,025, or 34.3%. The decrease was led by expenses directly affected by the COVID-19 pandemic. Specifically, legacy business personnel expenses decreased $5,636 from reduced variable compensation and travel, training costs decreased $1,911 from fewer live, group training events, and tradeshows and marketing costs decreased $1,103 largely on cancellation of key shows in 2020. Additionally, there was a $5,299 fluctuation in the contingent consideration liability adjustment as compared to prior year (see Note 3 for further discussion). Legal, consulting and professional services also declined $1,390, in part due to transaction costs incurred in 2019 for the SentreHEART acquisition. These decreases were offset by a $1,273 increase in share-based compensation and $1,464 incremental expenses for SentreHEART operations, primarily comprised of personnel costs.
Net interest expense. Net interest expense increased $725 due to an increase of $352 in interest expense reflecting the increase in borrowings and a decline of $373 in interest income due lower yields on recent investments as compared to 2019.
Six months ended June 30, 2020 compared to six months ended June 30, 2019
The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts and as percentages of revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Six Months Ended | ||||||||||
|
| June 30, | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 2020 |
| 2019 | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amount |
| % of |
| Amount |
| % of | ||||
Revenue |
| $ | 94,049 |
| 100.0 | % |
| $ | 112,872 |
| 100.0 | % |
Cost of revenue |
|
| 27,511 |
| 29.3 | % |
|
| 29,108 |
| 25.8 | % |
Gross profit |
|
| 66,538 |
| 70.7 | % |
|
| 83,764 |
| 74.2 | % |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
| 21,623 |
| 23.0 | % |
|
| 17,980 |
| 15.9 | % |
Selling, general and administrative expenses |
|
| 67,654 |
| 71.9 | % |
|
| 74,943 |
| 66.4 | % |
Total operating expenses |
|
| 89,277 |
| 94.9 | % |
|
| 92,923 |
| 82.3 | % |
Loss from operations |
|
| (22,739) |
| (24.2) | % |
|
| (9,159) |
| (8.1) | % |
Other income (expense): |
|
| (1,885) |
| (2.0) | % |
|
| (501) |
| (0.4) | % |
Loss before income tax expense |
|
| (24,624) |
| (26.2) | % |
|
| (9,660) |
| (8.6) | % |
Income tax expense |
|
| 20 |
| 0.0 | % |
|
| 76 |
| 0.1 | % |
Net loss |
| $ | (24,644) |
| (26.2) | % |
| $ | (9,736) |
| (8.6) | % |
Revenue. Revenue decreased 16.7% (16.5% on a constant currency basis) due to the deferral of more emergent medical procedures as a result of the COVID-19 pandemic. Revenue from customers in the United States decreased $13,032 or 14.5%, and revenue from international customers decreased $5,791, or 25.5% (24.5% on a constant currency basis). Sales in the United States declined across all product categories with open ablation sales decreasing $4,789 (12.1%) and appendage management sales decreasing $1,728 (5.4%). MIS ablation sales showed sharper declines in revenue, decreasing $5,538 (32.9%). International revenue declined in all product types throughout the major European and Asian markets as a result of the COVID-19 pandemic.
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 decreased $1,597 driven primarily by reductions in both sales and production as a result of the COVID-19 pandemic and the absorption of SentreHEART operations acquired in August 2019.
Research and development expenses. Research and development expenses increased $3,643, or 20.3%, primarily due to $3,774 incremental costs related to SentreHEART operations, including $1,476 for aMAZE clinical trial activities, $1,094 in personnel costs and $979 in consulting and product development activities.
Selling, general and administrative expenses. Selling, general and administrative expenses decreased $7,289, or 9.7%. Headcount expenses decreased $4,248 due to a $6,486 reduction in variable compensation and travel expenses as a result of decreased sales and travel restrictions imposed by COVID-19, offset by incremental SentreHEART personnel costs. Training activities decreased $1,379 and trade shows and marketing expenses decreased $916 primarily due to cancellations of in-person events as a result of COVID-19. Other expense reductions included $1,174 fluctuation in the contingent consideration liability adjustment as compared to prior year (see Note 3) and $1,097 decrease in legal, consulting and professional services. These decreases were offset by a $1,246 increase in stock-based compensation expense.
Net interest expense. Net interest expense increased $1,406 due to $718 higher interest expense reflecting the increase in borrowings and $688 lower investment income.
Liquidity and Capital Resources
As of June 30, 2020 the Company had cash, cash equivalents and investments of $247,837 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 $253,982 and an accumulated deficit of $306,841 as of June 30, 2020.
Cash flows used in operating activities. Net cash used in operating activities was $27,635. The primary net uses of cash for operating activities were as follows:
a net loss of $24,644 which contains $11,595 of non-cash expenses including $10,577 of share-based compensation, $4,902 of depreciation and amortization, offset by a $5,046 decrease in the contingent consideration liability.
a net decrease in cash used related to changes in operating assets and liabilities of $14,586, due primarily to the following:
•$16,811 primarily related to payment of variable compensation and timing of payments to vendors,
•$3,402 increase in inventories due to reduced sales volumes, and
•$5,127 decrease in accounts receivable due to declines in revenue.
Cash flows used in investing activities. Net cash used investing activities was $95,481 during the six months ended June 30, 2020. Cash used in activities was primarily from $127,069 of purchases of available-for-sale securities, offset by $33,732 of maturities of available-for-sale securities to fund operations.
Cash flows provided by financing activities. Net cash provided by financing activities during the six months ended June 30, 2020 was $183,240, which consists primarily of $188,958 in net proceeds from the May 2020 public stock offering and $6,889 in proceeds from stock option exercises and employee stock purchase plan activity. These increases were offset by $12,323 for shares repurchased for payment of taxes on stock awards.
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 are to be made ratably commencing March 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. 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 June 30, 2020 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. On April 29, 2020, the Company and SVB entered into an amendment to the Loan Agreement which modified a covenant related to the Company’s liquidity ratio through the third quarter of 2020 testing date and increased the early termination fees for both the term loan and revolving line of credit.
In connection with the terms of our corporate headquarters lease agreement, a letter of credit in the amount of $1,250 was issued to the landlord in October 2015. The letter of credit is renewed annually and remains outstanding as of June 30, 2020.
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 expand and support 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 six-month period 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. In May 2020, we completed a public offering of 4,574 shares of our common stock, and received net proceeds of $188,958 after underwriting discounts and commissions and offering costs.
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 nContact transaction provides for contingent consideration to be paid upon attaining specified regulatory approvals before January 2021. 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 nContact and SentreHEART merger agreements, such contingent consideration will be paid in AtriCure common stock and cash, up to a specified maximum number of shares. Over the next twelve months, we do not expect our cash requirements to include significant payments of contingent consideration based on terms of the respective acquisition agreement and progress towards achievement of the related milestones. See the heading “Legal” in Note 8 for a description of an earnout objection statement received from the nContact shareholder representative.
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, 2019 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
See Note 2 in the Notes to the Condensed Consolidated Financial Statements for a discussion of recent accounting pronouncements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Other than the negative impact the recent outbreak of the coronavirus (COVID-19) has had and will continue to have on our business and results of operations as discussed elsewhere in this report, as of June 30, 2020 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, 2019.
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 June 30, 2020 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 8 – 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, 2019 and in our Form 10-Q for the quarter ended March 31, 2020, all of which could materially affect our business, financial condition or future results. The risks described herein and 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 previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2019, as amended by risk factors provided in our Form 10-Q for the quarter ended March 31, 2020, except for the addition of the following:
The results of clinical trials for our products may not be predictive of future results, and our current and planned clinical trials may not satisfy the requirements of the FDA or other non-U.S. regulatory authorities.
Positive results from clinical trial experience should not be relied upon as evidence that any of our clinical trials will succeed or that they will satisfy regulatory requirements. Likewise, there can be no assurance that the results of studies conducted by collaborators or other third parties will be viewed favorably or are indicative of our own future study results. We may be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are either (i) safe and effective for use in a diverse population for their intended uses or (ii) are substantially equivalent in terms of safety and effectiveness to devices that are already marketed under section 510(k) of the Food, Drug and Cosmetic Act. Success in early clinical trials does not mean that future clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and other non-U.S. regulatory authorities despite having progressed through initial clinical trials.
Further, our devices and other products may not be approved or cleared even if they achieve their primary endpoints in clinical trials. In addition, our devices and products may not be approved or cleared, as the case may be, even though clinical or other data are, in our view, adequate to support an approval or clearance. The FDA or other non-U.S. regulatory authorities may disagree with our trial design and our interpretation of data from pre-clinical studies and clinical trials. In addition, any of these regulatory authorities may change requirements for the approval or clearance of a product candidate even after reviewing and providing comment on a protocol for a pivotal clinical trial that has the potential to result in FDA and other non-U.S. regulatory authorities’ approval. Any of these regulatory authorities may also approve or clear a product candidate for fewer or more limited indications or uses than we request or may grant approval or clearance contingent on the performance of costly post-marketing clinical trials. The FDA or other non-U.S. regulatory authorities may not approve the labeling claims necessary or desirable for the successful commercialization of our product candidates.
Our success depends, in part, on our ability to achieve regulatory approval for the marketing of the CONVERGE IDE device and the commercial success of this product.
On May 8, 2020, we announced the results from the CONVERGE IDE clinical trial. This trial achieves its primary efficacy endpoint with an approximately 18% difference in favor of the hybrid Convergent procedure as compared to standalone endocardial catheter ablation.
The CONVERGE trial primary efficacy endpoint is freedom from Afib, atrial tachycardia (AT), and atrial flutter (AFL), absent class I and III anti-arrhythmic drugs (AADs) except for a previously failed or demonstrated intolerance to class I or III AADs, with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit. The primary safety endpoint is the incidence of major adverse events (MAEs) specified in the protocol for subjects undergoing the Convergent
procedure from the time of the intervention through 30-days post intervention. There are no deaths, cardiac perforations, or atrio-esophageal fistulas reported in the CONVERGE trial, and the MAE rate of 7.8% in the treatment arm is lower than the protocol pre-specified performance goal of 12%. However, there can be no assurance that the FDA will consider the analysis or consider the product for approval.
Although our CONVERGE IDE device is currently cleared under section 510(k), we are also pursuing a pre-marketing approval (PMA) from the FDA. The process for obtaining marketing approval from the FDA or similar foreign governmental agencies is both time-consuming and costly, with no certainty of a successful outcome. In December 2019, we submitted the final module for our PMA. In April 2020, we received FDA comments and questions related to our PMA submission. We conducted an initial meeting with the FDA to discuss the FDA’s comments and questions but we can provide no assurance that we will be able to respond to the FDA’s comments and questions in a manner that is satisfactory to the FDA. There can be no assurance that we will obtain a marketing approval for the CONVERGE IDE device on a timely basis, or at all. Even if we obtain marketing approval, there can be no assurance that we will obtain FDA approval of both persistent and long-standing persistent indications for the CONVERGE IDE device. If we are unable to achieve marketing approval for the CONVERGE IDE device, our business will be significantly adversely impacted, which could have a materially adverse effect on our business, financial condition and results of operations.
Item 5. Other Information
On April 9, 2020 the Company reported in a Form 8-K that, as part of the expense-reduction measures related to the Company’s response to developments related to COVID-19, the Company’s executive officers voluntarily offered and recommended to the Board and the Compensation Committee that the Board and the Compensation Committee reduce the 2020 annual cash base salaries of the Company’s executive officers. Chief Executive Officer Michael H. Carrel took a 35% reduction in base salary, and the other members of the executive leadership team, including the Company’s other named executive officers, took a 20% reduction in base salary. On April 9, 2020, the Board and the Compensation Committee accepted the recommendations of the Company’s executive officers as described. In addition, and as a further cost-reduction measure, the Board reduced its 2020 cash compensation for non-employee directors by 35% from the amounts disclosed in the Company’s Proxy Statement filed with the SEC on April 8, 2020. The reduction applied to the annual board retainer, committee membership retainers, committee chair retainers and the retainer for the Chairman of the Board, and, as reported, were expected to last for up to six months. Effective for the June 30, 2020 payroll, the Company restored (i) the annual base salaries of all named executive officers to 100% and (ii) the cash compensation payable to non-employee directors to 100% of such levels as in effect prior to April 9, 2020. The restoration of the cash compensation payable to non-employee directors applied to the annual board retainer, committee membership retainers, committee chair retainers and the retainer for the Chairman of the Board.
Item 6. Exhibits
|
|
|
|
Exhibit No. | Description |
10.1 | |
10.2 | |
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) |
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: July 29, 2020 | /s/ Michael H. Carrel |
| Michael H. Carrel |
| President and Chief Executive Officer (Principal Executive Officer) |
|
|
|
|
Date: July 29, 2020 | /s/ M. Andrew Wade |
| M. Andrew Wade |
| 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: July 29, 2020
|
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, M. Andrew Wade, 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: July 29, 2020
|
By: |
/s/ M. Andrew Wade |
|
|
M. Andrew Wade |
|
|
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 June 30, 2020 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: July 29, 2020
|
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 June 30, 2020 as filed with the Securities and Exchange Commission on the date hereof (Report), I, M. Andrew Wade, 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: July 29, 2020
|
By: |
/s/ M. Andrew Wade |
|
|
M. Andrew Wade |
|
|
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.