20180630 Q2_Taxonomy2018

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

_____________________________________________

FORM 10-Q

_____________________________________________

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2018 

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from_____________to_____________

Commission File Number 000-51470

_____________________________________________

Picture 1

AtriCure, Inc.

(Exact name of Registrant as specified in its charter)

_____________________________________________

 







 

Delaware

34-1940305

(State or other jurisdiction

of incorporation)

(IRS Employer

Identification No.)

7555 Innovation Way

Mason, OH 45040

(Address of principal executive offices)

(513) 755-4100

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

_____________________________________________

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.

 



 

 

 



 

 

 

Large Accelerated Filer

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 30, 2018

Common Stock, $.001 par value

35,361,743







 

 

 


 

Table of Contents

 

 

Table of Contents





 

 

 

 

Page

PART I. FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

 

 

Condensed Consolidated Balance Sheets as of June 30, 2018 and December 31, 2017

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2018 and 2017

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017

 

Notes to Condensed Consolidated Financial Statements

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

18 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

24 

Item 4.

Controls and Procedures

24 

PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

24 

Item 1A.

Risk Factors

24 

Item 6.

Exhibits

25 

Signatures

26 



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Table of Contents

 

 

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,



 

2018

 

2017

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

13,866 

 

$

21,809 

Short-term investments

 

 

23,202 

 

 

12,642 

Accounts receivable, less allowance for doubtful accounts of $32 and $32

 

 

24,895 

 

 

23,083 

Inventories

 

 

21,682 

 

 

22,451 

Other current assets

 

 

3,120 

 

 

2,273 

Total current assets

 

 

86,765 

 

 

82,258 

Property and equipment, net

 

 

28,126 

 

 

28,749 

Intangible assets, net

 

 

50,080 

 

 

50,764 

Goodwill

 

 

105,257 

 

 

105,257 

Other noncurrent assets

 

 

619 

 

 

676 

Total Assets

 

$

270,847 

 

$

267,704 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

9,670 

 

$

12,431 

Accrued liabilities

 

 

17,161 

 

 

18,911 

Other current liabilities and current maturities of capital leases

 

 

589 

 

 

561 

Total current liabilities

 

 

27,420 

 

 

31,903 

Capital leases

 

 

12,492 

 

 

12,761 

Long-term debt

 

 

39,399 

 

 

24,100 

Other noncurrent liabilities

 

 

31,849 

 

 

37,774 

Total Liabilities

 

 

111,160 

 

 

106,538 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

Common stock, $0.001 par value, 90,000 shares authorized and 35,313 and 34,586 issued and

  outstanding

 

 

35 

 

 

35 

Additional paid-in capital

 

 

396,088 

 

 

386,963 

Accumulated other comprehensive (loss) income

 

 

(98)

 

 

34 

Accumulated deficit

 

 

(236,338)

 

 

(225,866)

Total Stockholders’ Equity

 

 

159,687 

 

 

161,166 

Total Liabilities and Stockholders’ Equity

 

$

270,847 

 

$

267,704 



See accompanying notes to condensed consolidated financial statements.

3

 


 

Table of Contents

 

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,



 

2018

 

2017

 

2018

 

2017

Revenue

 

$

51,802 

 

$

45,231 

 

$

98,796 

 

$

86,504 

Cost of revenue

 

 

13,723 

 

 

12,677 

 

 

26,214 

 

 

23,942 

Gross profit

 

 

38,079 

 

 

32,554 

 

 

72,582 

 

 

62,562 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

8,655 

 

 

8,907 

 

 

17,712 

 

 

18,457 

Selling, general and administrative expenses

 

 

28,466 

 

 

30,002 

 

 

63,342 

 

 

60,102 

Total operating expenses

 

 

37,121 

 

 

38,909 

 

 

81,054 

 

 

78,559 

Income (loss) from operations

 

 

958 

 

 

(6,355)

 

 

(8,472)

 

 

(15,997)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

        (1,221)

 

 

(564)

 

 

(2,041)

 

 

(1,118)

Interest income

 

 

           123

 

 

48 

 

 

199 

 

 

102 

Other

 

 

          (150)

 

 

 

 

(62)

 

 

(13)

Loss before income tax expense

 

 

(290)

 

 

(6,866)

 

 

(10,376)

 

 

(17,026)

Income tax expense 

 

 

            48

 

 

17 

 

 

96 

 

 

40 

Net loss

 

$

(338)

 

$

(6,883)

 

$

(10,472)

 

$

(17,066)

Basic and diluted net loss per share

 

$

          (0.01)

 

$

(0.21)

 

$

          (0.32)

 

$

(0.53)

Weighted average shares outstanding—basic and diluted

 

 

33,252 

 

 

32,288 

 

 

33,117 

 

 

32,154 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on investments

 

$

 

$

 

$

(7)

 

$

Foreign currency translation adjustment

 

 

(211)

 

 

342 

 

 

(125)

 

 

415 

Other comprehensive (loss) income

 

 

(210)

 

 

346 

 

 

(132)

 

 

421 

Net loss

 

 

(338)

 

 

(6,883)

 

 

(10,472)

 

 

(17,066)

Comprehensive loss, net of tax

 

$

(548)

 

$

(6,537)

 

$

(10,604)

 

$

(16,645)



See accompanying notes to condensed consolidated financial statements.

4

 


 

Table of Contents

 

ATRICURE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In  Thousands)

(Unaudited)





 

 

 

 

 

 

 



 

 

 

 

 

 

 



 

 

Six Months Ended



 

 

June 30,



 

 

2018

 

2017

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss

 

 

$

(10,472)

 

$

(17,066)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

Share-based compensation expense

 

 

 

7,424 

 

 

7,325 

Depreciation

 

 

 

3,719 

 

 

3,906 

Amortization of intangible assets

 

 

 

684 

 

 

684 

Amortization of deferred financing costs

 

 

 

217 

 

 

132 

Loss on disposal of property and equipment

 

 

 

97 

 

 

88 

Realized (gain) loss from foreign exchange on intercompany transactions

 

 

 

56 

 

 

(10)

(Accretion) amortization of investments

 

 

 

(56)

 

 

59 

Change in allowance for doubtful accounts

 

 

 

58 

 

 

(134)

Change in value of contingent consideration

 

 

 

(5,916)

 

 

 —

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

 

 

(1,946)

 

 

(1,673)

Inventories

 

 

 

703 

 

 

(2,094)

Other current assets

 

 

 

(877)

 

 

(26)

Accounts payable

 

 

 

(2,432)

 

 

565 

Accrued liabilities

 

 

 

(1,697)

 

 

(1,891)

Other noncurrent assets and liabilities

 

 

 

69 

 

 

(468)

Net cash used in operating activities

 

 

 

(10,369)

 

 

(10,603)

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchases of available-for-sale securities

 

 

 

(23,510)

 

 

(7,567)

Sales and maturities of available-for-sale securities

 

 

 

13,000 

 

 

16,350 

Purchases of property and equipment

 

 

 

(3,473)

 

 

(3,488)

Proceeds from sale of property and equipment

 

 

 

 

 

 —

Net cash (used in) provided by investing activities

 

 

 

(13,977)

 

 

5,295 

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from debt borrowings

 

 

 

17,381 

 

 

 —

Payments on debt and capital leases

 

 

 

(1,469)

 

 

(241)

Payment of debt fees

 

 

 

(1,136)

 

 

(50)

Shares repurchased for payment of taxes on stock awards

 

 

 

(3,724)

 

 

(1,901)

Proceeds from exercise of stock options and employee stock purchase plan

 

 

 

5,425 

 

 

4,279 

Net cash provided by financing activities

 

 

 

16,477 

 

 

2,087 

Effect of exchange rate changes on cash and cash equivalents

 

 

 

(74)

 

 

26 

Net decrease in cash and cash equivalents

 

 

 

(7,943)

 

 

(3,195)

Cash and cash equivalents—beginning of period

 

 

 

21,809 

 

 

24,208 

Cash and cash equivalents—end of period

 

 

$

13,866 

 

$

21,013 

Supplemental cash flow information:

 

 

 

 

 

 

 

Cash paid for interest

 

 

$

1,210 

 

$

985 

Cash paid for income taxes

 

 

 

45 

 

 

 —

Non-cash investing and financing activities:

 

 

 

 

 

 

 

Accrued purchases of property and equipment

 

 

 

366 

 

 

703 

Assets acquired through capital lease

 

 

 

24 

 

 

 —

Capital lease asset early termination

 

 

 

(6)

 

 

 —





See accompanying notes to condensed consolidated financial statements.







 

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Table of Contents

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

Nature of the Business—The “Company” consists of AtriCure, Inc. and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The Company is a  leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, and sells its products to medical centers globally through its direct sales force and distributors.

Basis of Presentation—The accompanying interim financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC). The accompanying interim financial statements are unaudited, but in the opinion of the Company’s management, contain all normal, recurring adjustments considered necessary to present fairly the financial position, results of operations and cash flows for the periods presented in conformity with accounting principles generally accepted in the United States of America (GAAP) applicable to interim periods. Certain information and footnote disclosures included in annual financial statements prepared in accordance with GAAP have been omitted or condensed. The Company believes the disclosures herein are adequate to make the information presented not misleading. Results of operations are not necessarily indicative of the results expected for the full year or for any future period.

The accompanying Condensed Consolidated Financial Statements should be read in conjunction with the audited financial statements of the Company included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC. 

Cash Equivalents—The Company considers highly liquid investments with maturities of three months or less at the date of purchase as cash equivalents in the accompanying Condensed Consolidated Financial Statements.

Investments—The Company invests primarily in U.S. Government securities, corporate bonds, commercial paper and asset-backed securities and classifies all investments as available-for-sale. Investments with maturities of less than one year are classified as short-term investments. Investments are recorded at fair value, with unrealized gains and losses recorded as accumulated other comprehensive income. Gains and losses are recognized using the specific identification method when securities are sold and are included in interest income or expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

Revenue Recognition—The Company recognizes revenue when control of promised goods is transferred to customers in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods. This generally occurs upon shipment of goods to customers. See Note 8 for further discussion on revenue.

Sales Returns and Allowances—The Company maintains a provision for potential returns of defective or damaged products and products shipped in error and invoice adjustments. The Company adjusts the provision through consideration of a combination of specific identification and historical experience. Increases to the provision result in a reduction of revenue. The provision is included in accrued liabilities in the Condensed Consolidated Balance Sheets.

Allowance for Doubtful Accounts Receivable—The Company evaluates the collectability of accounts receivable to determine the appropriate allowance for doubtful accounts considering the aging of accounts, historical credit losses, customer-specific information and other relevant factors. Increases to the allowance result in an increase in selling, general and administrative expenses. The Company adjusts the allowance based on current circumstances and charges off uncollectible receivables against the allowance when all attempts to collect the receivable have failed. The Company’s history of write-offs against the allowance has not been significant.

Inventories—Inventories are stated at the lower of cost or net realizable value based on the first-in, first-out cost method (FIFO). The Company’s industry is characterized by rapid product development and frequent new product introductions. Uncertain timing of regulatory approval, variability in product launch strategies and variation in product use cause the Company to maintain reserves for excess, obsolete and expired products. Increases to inventory reserves result in an increase in cost of revenue. Inventories are written off against reserves when they are physically disposed.

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Table of Contents

ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

Inventories consist of the following:







 

 

 

 

 

 



 

 

 

 

 

 



 

June 30,

 

December 31,



 

2018

 

2017

Raw materials

 

$

8,729 

 

$

7,755 

Work in process

 

 

1,549 

 

 

1,299 

Finished goods

 

 

11,404 

 

 

13,397 

Inventories

 

$

21,682 

 

$

22,451 

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 

1 - 3 years

Building under capital lease

15 years

Computers, software and office equipment

3 years

Machinery and equipment 

3 - 7 years

Furniture and fixtures

3 - 7 years

Leasehold improvements

5 - 15 years

Equipment under capital leases

3 - 5 years

The Company reassesses the useful lives of property and equipment at least annually and retires assets if they are no longer in service. Maintenance and repair costs are expensed as incurred.

The Company’s radiofrequency (RF) and cryo generators are generally placed with customers that use the Company’s disposable products. The estimated useful lives of generators are based on anticipated usage by customers and may change in future periods with changes in usage or introduction of new technologies. Depreciation related to generators and related equipment, which is recorded in cost of revenue in the Condensed Consolidated Statements of Operations and Comprehensive Loss, was $814 and $909 for the three months ended June 30, 2018 and 2017 and $1,641 and $1,825 for the six months ended June 30, 2018 and 2017. As of June 30, 2018 and December 31, 2017, the net carrying value of generators and related equipment included in net property and equipment in the Condensed Consolidated Balance Sheets was $4,717 and $4,656.

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.

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), which represents 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 approval. IPR&D is accounted for as an indefinite-lived intangible asset until completion or abandonment of the IPR&D project. Upon completion of the development project, IPR&D will be amortized over its estimated useful life. If the IPR&D project is abandoned, the IPR&D would be written off. IPR&D represents an estimate of the fair value of the pre-market approval (PMA) that may result from the CONVERGE IDE clinical trial.

The Company reviews intangible assets for impairment at least annually using its best estimates based on reasonable and supportable assumptions and projections. The Company has historically tested IPR&D for impairment annually on November 30.

Goodwill—Goodwill represents the excess of purchase price over the fair value of the net assets acquired in business combinations. The Company has historically tested goodwill for impairment annually on November 30, or more often if impairment indicators are present. The Company’s goodwill is accounted for in a single reporting unit representing the Company’s consolidated operations.  

Other Noncurrent Liabilities—Other noncurrent liabilities consist of acquisition-related contingent consideration and other contractual obligations. Although the Company expects to settle a portion of the contingent consideration liability in 2018, the balance

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Table of Contents

ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

is included in noncurrent liabilities as such settlement is both required and expected to be made in shares of the Company’s common stock pursuant to the nContact Surgical, Inc. (nContact) merger agreement.

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 invoicing 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, taxable income in carry-back years 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.

Net Loss Per ShareBasic and diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Since the Company has experienced net losses for all periods presented, net loss per share excludes the effect of 4,063 and 4,349 stock options, restricted stock shares, restricted stock units and performance award shares as of June 30, 2018 and 2017 because they are anti-dilutive. Therefore, the number of shares calculated for basic net loss per share is also used for the diluted net loss per share calculation.

Comprehensive Loss and Accumulated Other Comprehensive Income—In addition to net losses, the comprehensive loss includes foreign currency translation adjustments and unrealized losses on investments.

Accumulated other comprehensive income (loss) consisted of the following (net of tax):





 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2018

 

2017

 

2018

 

2017

Total accumulated other comprehensive income (loss) at beginning of period

 

$

112 

 

$

(393)

 

$

34 

 

$

(468)

Unrealized Losses on Investments

 

 

 

 

 

 

 

 

 

 

 

 

Balance at beginning of period

 

$

(14)

 

$

(19)

 

$

(6)

 

$

(21)

Other comprehensive income (loss) before reclassifications

 

 

 

 

 

 

(7)

 

 

Balance at end of period

 

$

(13)

 

$

(15)

 

$

(13)

 

$

(15)

Foreign Currency Translation Adjustment

 

 

 

 

 

 

 

 

 

 

 

 

Balance at beginning of period

 

$

126 

 

$

(374)

 

$

40 

 

$

(447)

Other comprehensive (loss) income before reclassifications

 

 

(349)

 

 

373 

 

 

(181)

 

 

425 

Amounts reclassified from accumulated other comprehensive income (loss) to other income (loss)

 

 

138 

 

 

(31)

 

 

56 

 

 

(10)

Balance at end of period

 

$

(85)

 

$

(32)

 

$

(85)

 

$

(32)

Total accumulated other comprehensive loss at end of period

 

$

(98)

 

$

(47)

 

$

(98)

 

$

(47)



Research and Development Costs—Research and development costs are expensed as incurred. These costs include compensation and other costs associated with the development of and research related to new and existing products or concepts, preclinical studies, clinical trials and regulatory affairs.

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Table of Contents

ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

Advertising CostsThe Company expenses advertising costs as incurred. Advertising costs were not significant during the three and six months ended June 30, 2018 and 2017.

Share-Based CompensationThe Company records share-based compensation for all employee share-based payment awards, including stock options, restricted stock, restricted stock units, performance shares and stock purchases related to an employee stock purchase plan, based on estimated fair values. The value of the portion of an award that is ultimately expected to vest, net of estimated forfeitures, is recognized as expense over the service period in the Company’s Condensed Consolidated Statements of Operations and Comprehensive Loss. The Company estimates forfeitures at the time of grant and adjusts them in subsequent periods if actual forfeitures differ from those estimates. The Company recognized share-based compensation expense of $3,534 and $3,697 for the three months ended June 30, 2018 and 2017 and $7,424 and $7,325 for the six months ended June 30, 2018 and 2017.

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 fair value is affected by the Company’s stock price, as well as subjective variables including, but not limited to, the Company’s expected stock price volatility over the term of the awards and actual and projected employee stock option exercise behaviors. The Company estimates the fair value of restricted stock, restricted stock units and performance shares based upon the grant date closing market price of the Company’s common stock.

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. At the beginning of each purchase period, the Company estimates the number of shares to be purchased in the period and the fair value of the shares based upon the Company’s stock price on the first day of the purchase period using the Black-Scholes model. Estimated compensation expense is recorded during the purchase period and is trued up to actual at the time of stock purchase.

Use of Estimates—The preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses and disclosure of contingencies in the financial statements. Actual results could differ from those estimates.    



2. RECENT ACCOUNTING PRONOUNCEMENTS

In February 2016, the FASB issued ASU 2016-02, “Leases” (ASU 2016-02), codified as ASC 842, which requires lessees to record most leases onto their balance sheet but recognize expenses on their income statement in a manner similar to today’s accounting. The guidance is effective for interim and annual reporting periods beginning within 2019.  An entity is required to use a modified retrospective approach for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. Full retrospective application is prohibited. The Company intends to adopt ASU 2016-02 on the effective date of January 1, 2019 and is currently evaluating the provisions of ASU 2016-02 to determine the 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 is evaluating the provisions of ASU 2017-04 to determine the impact on its consolidated financial statements and related disclosures.

In February 2018, the FASB issued ASU 2018-02, “Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (AOCI)” (ASU 2018-02) to address industry concerns related to the application of ASC 740, “Income Taxes” to certain provisions of the new tax reform legislation. Upon adopting ASU 2018-02, an entity is required to disclose (1) its accounting policy related to releasing income tax effects from AOCI, (2) whether it has elected to reclassify, to retained earnings in the statement of stockholders’ equity, the stranded tax effects in AOCI related to the new tax reform legislation and (3) if it has elected to reclassify to retained earnings the stranded tax effects in AOCI related to the new tax reform legislation, what the reclassification encompasses. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. An entity will apply this guidance to each period in which the effect of the new tax reform legislation (or portion thereof) is recorded and may apply it either (1) retrospectively as of the date of enactment or (2) as of the beginning of the period of adoption. The Company has evaluated the impact of the provisions of ASU 2018-02 on its consolidated financial position, results of operations and related disclosures and determined that the new guidance will not have a material impact on its financial reporting upon adoption.

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ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

In March 2018, the FASB issued ASU 2018-05, “Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin (SAB) No. 118 (ASU 2018-05) to amend SEC paragraphs in ASC 740, Income Taxes, to reflect SAB 118, which provides guidance for companies that are not able to complete their accounting for the income tax effects of the Tax Cuts and Jobs Act in the period of enactment. The Company is applying the guidance in SAB 118 when accounting for the enactment-date effects of the Act. See Note 9 for further discussion.

In July 2018, the FASB issued ASU 2018-10, “Codification Improvements to Topic 842, Leases” (ASU 2018-10). The amendments in this ASU address the rate implicit in the lease, impairment of the net investment in the lease, lessee reassessment of lease classification, lessor reassessment of lease term and purchase options, variable payments that depend on an index or rate and certain transition adjustments, among other things. The amendments have the same effective date as ASU 2016-02, which is effective for interim and annual reporting periods beginning within 2019.  The Company is evaluating the provisions of ASU 2018-10 to determine the impact on its consolidated financial statements and related disclosures.



3. FAIR VALUE

Fair value is defined as the price that would be received upon the sale of an asset or paid to transfer a 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 defines a three-level valuation hierarchy for classification and disclosure of fair value measurements as follows:  

·

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, investments in U.S. government 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 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.  

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 June 30, 2018:  







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Quoted Prices in
Active Markets for
Identical Assets
(Level 1)

 

Significant Other
Observable Inputs
(Level 2)

 

Significant Other
Unobservable
Inputs (Level 3)

 

Total 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

 —

 

$

2,603 

 

$

 —

 

$

2,603 

Commercial paper

 

 

 —

 

 

8,541 

 

 

 —

 

 

8,541 

U.S. government securities

 

 

2,584 

 

 

 —

 

 

 —

 

 

2,584 

Corporate bonds

 

 

 —

 

 

8,099 

 

 

 —

 

 

8,099 

Asset-backed securities

 

 

 —

 

 

3,978 

 

 

 —

 

 

3,978 

Total assets

 

$

2,584 

 

$

23,221 

 

$

 —

 

$

25,805 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Acquisition-related contingent consideration

 

 

 —

 

 

 —

 

 

31,182 

 

 

31,182 

Total liabilities

 

$

 —

 

$

 —

 

$

31,182 

 

$

31,182 

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, 2018.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

The following table represents the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2017:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Quoted Prices in
Active Markets for
Identical Assets
(Level 1)

 

Significant Other
Observable Inputs
(Level 2)

 

Significant Other
Unobservable
Inputs (Level 3)

 

Total 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

 —

 

$

12,774 

 

$

 —

 

$

12,774 

Commercial paper

 

 

 —

 

 

7,472 

 

 

 —

 

 

7,472 

U.S. government agencies and securities

 

 

2,999 

 

 

 —

 

 

 —

 

 

2,999 

Corporate bonds

 

 

 —

 

 

2,920 

 

 

 —

 

 

2,920 

Total assets

 

$

2,999 

 

$

23,166 

 

$

 —

 

$

26,165 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Acquisition-related contingent consideration

 

 

 —

 

 

 —

 

 

37,098 

 

 

37,098 

Total liabilities

 

$

 —

 

$

 —

 

$

37,098 

 

$

37,098 

Acquisition-Related Contingent Consideration. Contingent consideration arrangements under the nContact merger agreement obligate the Company to pay certain defined amounts to former shareholders of nContact if specified milestones are met related to trial enrollment, regulatory approval and revenue targets. The Company measures contingent consideration liabilities using unobservable inputs by applying an income approach, such as the discounted cash flow technique or the probability-weighted scenario method. Various key assumptions, such as the probability of achievement of the agreed milestones, projected revenues from acquisitions and the discount rate, 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. Subsequent revisions to key assumptions, which impact the estimated fair value of contingent consideration liabilities, are reflected in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Acquisition-related contingent consideration is recorded in other noncurrent liabilities in the Condensed Consolidated Balance Sheets.

The fair value of the nContact contingent consideration was remeasured as of June 30, 2018, resulting in a decrease in fair value of $5,916. This decrease is primarily due to changes in estimates related to the timing of achievement of the regulatory milestone as a result of enrollment in the CONVERGE IDE clinical trial in 2018, a decrease in forecasted revenues under the commercial milestone payment and a higher discount rate, reflecting increases in market interest rates and changes to the Company’s debt structure.  The adjustment to fair value is recorded in selling, general and administrative expenses in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss. 

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,

 

 

December 31, 2017

Beginning Balance

 

$

37,098 

 

 

$

41,176 

Amounts acquired

 

 

 —

 

 

 

 —

Changes in fair value included in earnings

 

 

(5,916)

 

 

 

(4,078)

Ending Balance

 

$

31,182 

 

 

$

37,098 



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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 



4. INTANGIBLE ASSETS

The following table provides a summary of the Company’s intangible assets:







 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

June 30, 2018

 

December 31, 2017



Estimated Useful Life

 

Cost 

 

Accumulated
Amortization

 

Cost

 

Accumulated
Amortization 

Fusion technology

10 years

 

$

9,242 

 

$

4,159 

 

$

9,242 

 

$

3,697 

SUBTLE access technology

5 years

 

 

2,179 

 

 

1,203 

 

 

2,179 

 

 

981 

IPR&D

 

 

 

44,021 

 

 

 —

 

 

44,021 

 

 

 —

Total

 

 

$

55,442 

 

$

5,362 

 

$

55,442 

 

$

4,678 

Amortization expense of intangible assets with definite lives, which excludes IPR&D, was $342 for both the three months ended June 30, 2018 and 2017 and $684 for both the six months ended June 30, 2018 and 2017.

Amortization expense of intangible assets with definite lives is projected as follows:







 

 

 

 

 



 

 

 

 

 

2018

 

$

683 

 

July 1, 2018 through December 31, 2018

2019

 

 

1,367 

 

 

2020

 

 

1,235 

 

 

2021

 

 

924 

 

 

2022

 

 

925 

 

 

2023 and thereafter

 

 

925 

 

 

Total

 

$

6,059 

 

 

 



5. ACCRUED LIABILITIES

Accrued liabilities consisted of the following:







 

 

 

 

 

 



 

 

 

 

 

 



 

June 30,

 

December 31,



 

2018

 

2017

Accrued commissions

 

$

5,416 

 

$

6,964 

Accrued payroll and employee-related expenses

 

 

4,370 

 

 

4,097 

Accrued bonus

 

 

4,163 

 

 

4,726 

Sales returns and allowances

 

 

1,319 

 

 

1,169 

Other accrued liabilities

 

 

701 

 

 

695 

Accrued royalties

 

 

669 

 

 

626 

Accrued taxes

 

 

523 

 

 

634 

Total

 

$

17,161 

 

$

18,911 

 





6. INDEBTEDNESS

Credit Facility. The Company has a Loan and Security Agreement (Loan Agreement) with Silicon Valley Bank (SVB). The Loan Agreement, as amended and restated effective February 23, 2018, includes a $40,000 term loan and a $20,000 revolving line of credit, with an option to increase the revolving line of credit by up to an additional $20,000. The term loan and revolving line of credit each have a five-year term,  maturing or expiring, as applicable, in February 2023.  

Principal payments of the term loan are to be made ratably commencing eighteen months after the inception of the loan (September 2019) 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 six months. The term loan accrues interest at the greater of the Prime Rate plus 3.75%, or 8.25%,  and is subject to an additional 3.5% fee on the original $40,000 term loan principal

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

payable at maturity or upon acceleration or prepayment of the term loan. The Company is accruing the 3.5% fee over the term of the Loan Agreement. As of June 30, 2018, the Company accrued $93 of this fee, reflected in the outstanding loan balance in the Condensed Consolidated Balance Sheets. The refinancing was treated as a debt modification. Financing costs related to the term loan of $744 are netted against the outstanding loan balance in the Condensed Consolidated Balance Sheets and amortized ratably over the term of the Loan Agreement.

The revolving line of credit is subject to an annual facility fee of 0.33% of the revolving line of credit, and any borrowings bear interest at the greater of the Prime Rate or 4.50%.  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. As of June 30, 2018, the Company had no borrowings under the revolving credit facility and had borrowing availability of $18,750. Financing costs related to the revolving line of credit are included in other assets in the Condensed Consolidated Balance Sheets and amortized ratably over the twelve-month period of the annual fee.  

The Loan Agreement contains prepayment and early termination fees and establishes a financial covenant related to sales growth, along with other customary terms and conditions. Specified assets have been pledged as collateral.

Capital Lease Obligations. As of June 30, 2018, the Company had capital leases for its corporate headquarters building and certain equipment that expire at various terms through 2030.  Capital lease assets are depreciated over their estimated useful lives. As of June 30, 2018, the cost of the leased assets, both building and equipment, was $14,462, and related accumulated amortization was $2,699.  

In connection with the terms of the Company’s corporate headquarters lease, a letter of credit in the amount of $1,250 was issued to the building lessor in October 2015. The letter of credit is renewed annually and remained outstanding as of June 30, 2018.

Future maturities of long-term debt, including the term loan fee payable at maturity, and capital lease obligations are projected as follows:





 

 

 

 

 



 

 

 

 

 

2018

 

$

736 

 

July 1, 2018 through December 31, 2018

2019

 

 

5,303 

 

 

2020

 

 

12,943 

 

 

2021

 

 

12,947 

 

 

2022

 

 

12,968 

 

 

2023 and thereafter

 

 

16,260 

 

 

Total payments

 

$

61,157 

 

 

Imputed interest

 

 

(6,676)

 

 

Net long-term debt and capital lease obligations, of which $589 is current and $53,892 is noncurrent

 

$

54,481 

 

 







7. COMMITMENTS AND CONTINGENCIES

Lease Commitments. The Company leases certain office and warehouse facilities under noncancelable operating leases with various terms that expire through 2022.  

Royalty Agreements. The Company has certain royalty agreements in place with terms that include payment of royalties of 3% to 5% of specified product sales. The royalty agreements have effective dates as early as 2003 and terms ranging from eighteen to at least twenty years, unless terminated earlier. Royalty expense of $695 and $602 is included in cost of revenue for the three months ended June 30, 2018 and 2017. Royalty expense of $1,367 and $1,136 is included in cost of revenue for the six months ended June 30, 2018 and 2017.

Purchase Agreements. The Company enters into standard purchase agreements with various suppliers in the ordinary course of business. Outstanding commitments outside of the ordinary course of business were not significant at June 30, 2018.

Legal. The Company may, from time to time, become a party to legal proceedings and receive inquiries from regulators. 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 the Company has assessed that a loss is probable and an amount can be reasonably estimated, it records a liability in the Condensed Consolidated Financial Statements. Costs associated with legal

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

proceedings could have a material adverse effect on the Company’s future consolidated results of operations, financial position, or cash flows. 

The Company received a Civil Investigative Demand (CID) from the U.S. Department of Justice 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, and it is working with the U.S. Department of Justice to promptly respond to the CID. 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 report delivered in February 2018, the Company received a letter from the representative on March 16, 2018. The letter purports to serve as an “earnout objection statement” (as that term is defined in the merger agreement) and claims 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 previously included in its earnout statements. The Company has disputed the basis of the representative’s claims, and has corresponded with the representative regarding the earnout objection statement. 



8. REVENUE

The Company adopted FASB ASC 606, “Revenue from Contracts with Customers” (ASC 606) using the modified retrospective method effective January 1, 2018. The adoption of ASC 606 did not have a material impact on the amount and timing of revenue recognized in the Condensed Consolidated Financial Statements.

Revenue is generated primarily from the sale of disposable surgical 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 disposable surgical 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-heart 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 of a provision for returns. The Company considers the following 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.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

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 in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

See Note 11 for disaggregated revenue by geographic area and by product category.



9. INCOME TAX PROVISION

The Company files federal, state, and foreign income tax returns in jurisdictions with varying statutes of limitations. The Company uses the asset and liability method to determine its provision for income taxes. The Company’s provision for income taxes in interim periods is computed by applying its estimated annual effective rate against its pre-tax results for the period. Non-recurring items are recorded during the period in which they occur. The effective tax rate for the three months ended June 30, 2018 and 2017 was (16.64%) and (0.25%).  The effective tax rate for the six months ended June 30, 2018 and 2017 was (0.92%) and (0.23%).

The Tax Cuts and Jobs Act (TCJA) was enacted on December 22, 2017. The TCJA reduces the United States federal corporate income tax rate from 35% to 21%, along with other changes to tax law. As a result of the Company’s valuation allowance on its net U.S. deferred tax assets, the TCJA did not have an impact on the effective tax rate for the three and six months ended June 30, 2018 as compared to June 30, 2017. 

The Company is applying the guidance in Staff Accounting Bulletin No. 118, “Income Tax Accounting Implications of the Tax Cut and Jobs Act” (SAB 118) when accounting for the enactment-date effects of the TCJA. As of June 30, 2018, the Company has not adjusted the provisional amounts recognized as of December 31, 2017. The provisional amounts recorded may be affected as the Company completes additional analysis of the tax law provisions. These changes are not anticipated to be material to the Company’s Condensed Consolidated Financial Statements as a result of a full valuation allowance against the Company’s net U.S. deferred tax assets.

Federal, state and local tax 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 in the Condensed Consolidated Statements of Operations and Comprehensive Loss and within the related tax liability in the Condensed Consolidated Balance Sheets. 



10. EQUITY COMPENSATION PLANS

The Company has two share-based incentive plans: the 2014 Stock Incentive Plan (2014 Plan) and the 2018 Employee Stock Purchase Plan (ESPP).

Stock Incentive Plan

Under the 2014 Plan, the Board of Directors may grant incentive stock options to employees and may grant nonstatutory stock options, restricted stock, restricted stock units, performance shares or stock appreciation rights to employees, directors and consultants. The administrator (the Compensation Committee of the Board of Directors) has the authority to determine the terms of any awards, including the number of shares subject to each award, the exercisability of the awards and the form of consideration. As of June 30, 2018,  10,249 shares of common stock had been reserved for issuance under the 2014 Plan, and 513 shares were available for future grants.  An additional 850 shares were approved by stockholders at the Company’s 2018 Annual Meeting of Stockholders in May 2018 which will be registered during the third quarter of 2018.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

Effective March 1, 2018, the Compensation Committee of the Board approved the grant of performance share awards (2018 PSAs) to the Company’s named executive officers and certain other executive employees pursuant to the Company’s 2014 Stock Incentive Plan. The form of award agreement for the 2018 PSAs (2018 PSA Grant Form) provides, among other things, that (i) each 2018 PSA that vests represents the right to receive one share of the Company’s common stock; (ii) the 2018 PSAs vest based on the Company achieving specified performance measurements over a performance period of three years, beginning January 1, 2018; (iii) the performance measurements include revenue CAGR as defined in the 2018 PSA Grant Form; (iv) threshold, target and maximum payout opportunities established for the 2018 PSAs will be used to calculate the number of shares that will be issuable when the award vests, which may range from 0% to 200% of the target amount; (v) any 2018 PSAs that are earned are scheduled to vest and be settled in shares of the Company’s common stock at the end of the performance period; and  (vi) all or a portion of the 2018 PSAs may vest following a change of control or a termination of service by reason of death or disability (each as described in greater detail in the 2018 PSA Grant Form).

With respect to the 2018 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 of the Board. The Company estimated the fair value of the 2018 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 granted prior to 2018 under the 2014 Plan generally expire ten years from the date of grant and generally vest at a rate of 25% on the first anniversary date of the grant and ratably each month thereafter over the following three years. Restricted stock awards granted prior to 2018 generally vest between one and four years from the date of grant. Beginning in 2018, stock options granted generally vest in one-third increments on the first, second and third anniversaries of the grant date, and restricted stock awards generally vest on the grant date anniversaries between one and three years from the date of grant. Restricted stock units vest in one-third increments on the first, second and third anniversaries of the grant date.

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 (15%) of the lesser of the closing price of the Company’s common stock on the first trading day or the last trading day of the offering period. The offering period (currently six months) and the offering price are subject to change. Participants may not purchase a value of more than $25 of the Company’s common stock in a calendar year and may not purchase more than 3 shares during an offering period. The ESPP was approved by stockholders at the Company’s 2018 Annual Meeting of Stockholders in May 2018, resulting in an increase of 500 shares available for sale under the ESPP which will be registered during the third quarter of 2018.  As of June 30, 2018, there were 136 shares available for future issuance under the ESPP. 

Expense Information Under FASB ASC 718

The following table summarizes the allocation of share-based compensation expense: 







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2018

 

2017

 

2018

 

2017

Cost of revenue

 

$

239 

 

$

138 

 

$

476 

 

$

269 

Research and development expenses

 

 

361 

 

 

502 

 

 

952 

 

 

1,003 

Selling, general and administrative expenses

 

 

2,934 

 

 

3,057 

 

 

5,996 

 

 

6,053 

Total

 

$

3,534 

 

$

3,697 

 

$

7,424 

 

$

7,325 

 



11. SEGMENT AND GEOGRAPHIC INFORMATION

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, was as follows:

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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,



 

2018

 

2017

 

2018

 

2017

United States

 

$

40,834 

 

$

35,534 

 

$

79,270 

 

$

68,802 

Europe

 

 

6,694 

 

 

5,688 

 

 

12,565 

 

 

10,877 

Asia

 

 

4,049 

 

 

3,785 

 

 

6,488 

 

 

6,436 

Other international

 

 

225 

 

 

224 

 

 

473 

 

 

389 

Total international

 

 

10,968 

 

 

9,697 

 

 

19,526 

 

 

17,702 

Total revenue

 

$

51,802 

 

$

45,231 

 

$

98,796 

 

$

86,504 



United States revenue by product type was as follows:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2018

 

2017

 

2018

 

2017

Open-heart ablation

 

$

18,073 

 

$

16,790 

 

$

35,652 

 

$

32,495 

Minimally invasive ablation

 

 

9,114 

 

 

8,725 

 

 

17,727 

 

 

17,007 

Appendage management

 

 

13,101 

 

 

9,463 

 

 

24,898 

 

 

18,165 

Total ablation and appendage management

 

 

40,288 

 

 

34,978 

 

 

78,277 

 

 

67,667 

Valve tools

 

 

546 

 

 

556 

 

 

993 

 

 

1,135 

Total United States

 

$

40,834 

 

$

35,534 

 

$

79,270 

 

$

68,802 



International revenue by product type was as follows:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2018

 

2017

 

2018

 

2017

Open-heart ablation

 

$

5,836 

 

$

5,674 

 

$

10,745 

 

$

10,264 

Minimally invasive ablation

 

 

2,660 

 

 

2,135 

 

 

4,452 

 

 

4,093 

Appendage management

 

 

2,424 

 

 

1,777 

 

 

4,222 

 

 

3,172 

Total ablation and appendage management

 

 

10,920 

 

 

9,586 

 

 

19,419 

 

 

17,529 

Valve tools

 

 

48 

 

 

111 

 

 

107 

 

 

173 

Total international

 

$

10,968 

 

$

9,697 

 

$

19,526 

 

$

17,702 

The Company’s long-lived assets are located primarily in the United States, except for $1,006 as of June 30, 2018 and $957 as of December 31, 2017, which are located primarily in Europe.

 

 

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Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

(Dollar amounts referenced in this Item 2 are in thousands, except per share amounts.)

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying Condensed Consolidated Financial Statements and notes thereto contained in Item 1 of Part I of this Form 10-Q and our audited financial statements and notes thereto as of and for the year ended December 31, 2017 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, 2017. 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 longstanding 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 various types of cardiothoracic surgery.  Our AtriClip® Left Atrial Appendage Exclusion System is a device specifically designed to occlude the heart’s left atrial appendage.

Physicians have adopted our radiofrequency (RF) ablation and cryoablation systems to treat Afib, and we believe that we are currently the market leader in the surgical treatment of Afib. Our products are used by physicians during both open-heart and minimally invasive surgical procedures, either on a concomitant or standalone basis. During a concomitant procedure, the physician ablates cardiac tissue and/or occludes the LAA, secondary, or concomitant, to a primary structural heart procedure such as a valve repair or replacement or coronary artery bypass graft (CABG). 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 cleared 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, our cryoICE probe is cleared for managing pain by temporarily ablating peripheral nerves. Our AtriClip products are 510(k)-cleared with an indication for the occlusion 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. We also have a line of reusable surgical instruments typically used for cardiac valve replacement or repair. Our Isolator Synergy clamps, Isolator Synergy pens, Coolrail linear pen, cryosurgery devices, AtriClip LAA Exclusion System, COBRA Fusion Ablation System, Numeris System and the EPi-Sense Guided Coagulation System with VisiTrax technology 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 directives. 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

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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

FDA conducted a periodic quality system inspection at our Cincinnati, Ohio facility in February and March 2018. The audit resulted in the issuance of a Form FDA 483, Inspectional Observations, which outlined certain non-conformances within our Process Validation, Corrective and Preventative Action (CAPA) and Device History Record processes as observed by the FDA inspector. We responded to the observations and have taken corrective actions where appropriate without a material impact on our financial results.

Clinical trials are required to support a pre-market approval (PMA) and are sometimes required for 510(k) clearance. In the United States, clinical trials for a significant risk device require the prior submission of an application for an Investigational Device Exemption (IDE) to FDA for approval. An IDE application must be submitted before initiating a new clinical trial. Some trials require a feasibility study followed by a pivotal trial. An IDE supplement is requested as a means of obtaining approval to initiate a pivotal trial following the conclusion of a feasibility trial. 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 trials and studies are:

CONVERGE.  We are conducting the CONVERGE IDE clinical trial to evaluate the safety and efficacy of the EPi-Sense® Guided Coagulation System with VisiTrax® technology to treat symptomatic persistent Afib patients who are refractory or intolerant to at least one Class I and/or III anti-arrhythmic drug. The trial provides for enrollment of up to 153 patients at 27 domestic medical centers and three international medical centers.  Enrollment began in 2014 and is expected to end in 2018. 

ATLAS. The ATLAS study is a non-IDE randomized pilot study evaluating outcomes of patients with risk factors for developing postoperative Afib as well as risk of bleeding on oral anticoagulation. There are two types of patients subject to this study:  those with a postoperative Afib diagnosis and receiving prophylactic exclusion of the left atrial appendage with the AtriClip device concomitant to cardiac surgery and those with a postoperative Afib diagnosis who are medically managed. Enrollment began in February 2016 and ended in the second quarter of 2018. 

FROST. We are conducting a cryoanalgesia study, which is a non-IDE randomized pilot study evaluating whether intraoperative intercostal cryoanalgesia in conjunction with standard of care provides improved analgesic efficacy in patients undergoing unilateral thoracotomy cardiac procedures as compared to the current standard of care. The study involves treatment arm patients who receive intercostal cryoanalgesia in conjunction with standard post-operative pain management and control arm patients who receive standard post-operative pain management only. The study provides for enrollment of up to 100 patients at five medical centers. Enrollment began in June 2016 and remains ongoing.

DEEP AF Pivotal Study. The DEEP AF pivotal trial evaluates the safety and efficacy of the Isolator Synergy System when used in a staged approach, where a minimally invasive surgical ablation procedure is first performed and the patient undergoes the intracardiac catheter procedure approximately 90-120 days later. The trial provides for enrollment of up to 220 patients at 23 U.S. medical centers and two international medical centers. The trial was paused during 2016-2017 due to our work to mitigate the risk related to esophageal injury during the procedure. We are committed to patient safety, and we are working collaboratively with FDA to obtain final clearance to move toward full enrollment of the trial.

CEASE AF.  We are also pursuing a non-IDE trial in Europe to compare staged hybrid ablation treatment (minimally invasive surgical ablation procedure is first performed and the patient undergoes the intracardiac catheter procedure approximately 91-180 days later) versus catheter ablation alone.  The study protocol provides for enrollment of approximately 210 patients at twelve sites. Enrollment began in November 2015 and remains ongoing.



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Results of Operations

Three months ended June 30, 2018 compared to three months ended June 30, 2017 

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,



 

2018

 

2017



 

Amount 

 

% of
Revenues

 

Amount 

 

% of
Revenues

Revenue

 

$

51,802 

 

100.0 

%

 

$

45,231 

 

100.0 

%

Cost of revenue

 

 

13,723 

 

26.5 

%

 

 

12,677 

 

28.0 

%

Gross profit

 

 

38,079 

 

73.5 

%

 

 

32,554 

 

72.0 

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

8,655 

 

16.7 

%

 

 

8,907 

 

19.7 

%

Selling, general and administrative expenses

 

 

28,466 

 

55.0 

%

 

 

30,002 

 

66.3 

%

Total operating expenses

 

 

37,121 

 

71.7 

%

 

 

38,909 

 

86.0 

%

Income (loss) from operations

 

 

958 

 

1.8 

%

 

 

(6,355)

 

(14.1)

%

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(1,221)

 

(2.4)

%

 

 

(564)

 

(1.2)

%

Interest income

 

 

123 

 

0.2 

%