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EX-32.1 - EX-32.1 - AtriCure, Inc.atrc-20160630xex32_1.htm
EX-32.2 - EX-32.2 - AtriCure, Inc.atrc-20160630xex32_2.htm
EX-31.2 - EX-31.2 - AtriCure, Inc.atrc-20160630xex31_2.htm
EX-31.1 - EX-31.1 - AtriCure, Inc.atrc-20160630xex31_1.htm

 

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, 2016

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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. See the definitions of “large accelerated filer, accelerated filer and smaller reporting company” in Rule 12b-2 of the Exchange Act.

 



 

 

 



 

 

 

Large Accelerated Filer

Accelerated Filer



 

 

 

Non-Accelerated Filer

 (Do not check if a smaller reporting company)

Smaller reporting company



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 August 3, 2016

Common Stock, $.001 par value

33,202,924







 

 

 


 

 

Table of Contents







 

 

 

 

Page

PART I. FINANCIAL INFORMATION

 

Item 1.

Financial Statements

 

 

Condensed Consolidated Balance Sheets as of June 30, 2016 and December 31, 2015

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2016 and 2015

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2016 and 2015

 

Notes to Condensed Consolidated Financial Statements

Item 2.

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

19 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25 

Item 4.

Controls and Procedures

25 

PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

25 

Item 1A.

Risk Factors

25 

Item 6.

Exhibits

26 

Signatures

27 

Exhibit Index

28 



 

2


 

 

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,



 

2016

 

2015

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

19,917 

 

$

23,764 

Short-term investments

 

 

22,510 

 

 

10,814 

Accounts receivable, less allowance for doubtful accounts of $75 and $136, respectively

 

 

21,354 

 

 

19,409 

Inventories

 

 

19,311 

 

 

17,659 

Other current assets

 

 

3,373 

 

 

3,106 

Total current assets

 

 

86,465 

 

 

74,752 

Property and equipment, net

 

 

30,902 

 

 

31,279 

Long-term investments

 

 

5,525 

 

 

7,706 

Intangible assets, net

 

 

52,953 

 

 

53,775 

Goodwill

 

 

105,257 

 

 

105,257 

Other noncurrent assets

 

 

411 

 

 

323 

Total Assets

 

$

281,513 

 

$

273,092 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

11,926 

 

$

12,744 

Accrued liabilities

 

 

12,790 

 

 

18,394 

Other current liabilities and current maturities of capital leases

 

 

473 

 

 

450 

Total current liabilities

 

 

25,189 

 

 

31,588 

Capital leases

 

 

13,504 

 

 

13,710 

Long-term debt

 

 

24,969 

 

 

Other noncurrent liabilities

 

 

40,851 

 

 

41,109 

Total Liabilities

 

 

104,513 

 

 

86,407 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

Common stock, $0.001 par value, 90,000 shares authorized and 33,203 and 32,274 issued and

  outstanding, respectively

 

 

33 

 

 

32 

Additional paid-in capital

 

 

361,023 

 

 

352,900 

Accumulated other comprehensive loss

 

 

(490)

 

 

(611)

Accumulated deficit

 

 

(183,566)

 

 

(165,636)

Total Stockholders’ Equity

 

 

177,000 

 

 

186,685 

Total Liabilities and Stockholders’ Equity

 

$

281,513 

 

$

273,092 



See accompanying notes to condensed consolidated financial statements.

3


 

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,



 

2016

 

2015

 

2016

 

2015

Revenue

 

$

39,672 

 

$

32,583 

 

$

75,612 

 

$

62,469 

Cost of revenue

 

 

10,854 

 

 

9,466 

 

 

20,880 

 

 

17,617 

Gross profit

 

 

28,818 

 

 

23,117 

 

 

54,732 

 

 

44,852 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

9,124 

 

 

5,862 

 

 

17,687 

 

 

11,471 

Selling, general and administrative expenses

 

 

27,432 

 

 

22,074 

 

 

54,202 

 

 

43,344 

Total operating expenses

 

 

36,556 

 

 

27,936 

 

 

71,889 

 

 

54,815 

Loss from operations

 

 

(7,738)

 

 

(4,819)

 

 

(17,157)

 

 

(9,963)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(477)

 

 

(17)

 

 

(736)

 

 

(35)

Interest income

 

 

60 

 

 

43 

 

 

99 

 

 

86 

Other

 

 

(34)

 

 

(90)

 

 

(114)

 

 

(231)

Loss before income tax expense

 

 

(8,189)

 

 

(4,883)

 

 

(17,908)

 

 

(10,143)

Income tax expense 

 

 

17 

 

 

 

 

22 

 

 

14 

Net loss

 

$

(8,206)

 

$

(4,891)

 

$

(17,930)

 

$

(10,157)

Basic and diluted net loss per share

 

$

(0.26)

 

$

(0.18)

 

$

         (0.57)

 

$

(0.37)

Weighted average shares outstanding—basic and diluted

 

 

31,575 

 

 

27,304 

 

 

31,466 

 

 

27,187 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gains on investments

 

$

13 

 

$

 

$

54 

 

$

39 

Foreign currency translation adjustment

 

 

(219)

 

 

253 

 

 

67 

 

 

(234)

Other comprehensive income (loss)

 

 

(206)

 

 

255 

 

 

121 

 

 

(195)

Net loss

 

 

(8,206)

 

 

(4,891)

 

 

(17,930)

 

 

(10,157)

Comprehensive loss

 

$

(8,412)

 

$

(4,636)

 

$

(17,809)

 

$

(10,352)



See accompanying notes to condensed consolidated financial statements.

4


 



ATRICURE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In  Thousands)

(Unaudited)





 

 

 

 

 

 

 



 

 

 

 

 

 

 



 

 

Six Months Ended



 

 

June 30,



 

 

2016

 

2015

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss

 

 

$

(17,930)

 

$

(10,157)

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

 

 

 

 

 

 

 

Share-based compensation expense

 

 

 

5,869 

 

 

4,141 

Depreciation

 

 

 

3,678 

 

 

2,087 

Amortization of intangible assets

 

 

 

822 

 

 

606 

Amortization of deferred financing costs

 

 

 

86 

 

 

31 

Loss on disposal of property and equipment

 

 

 

117 

 

 

63 

Realized (gain) loss from foreign exchange on intercompany transactions

 

 

 

(15)

 

 

302 

Amortization/accretion on investments

 

 

 

74 

 

 

339 

Change in allowance for doubtful accounts

 

 

 

(49)

 

 

117 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

 

 

(1,897)

 

 

(468)

Inventories

 

 

 

(1,595)

 

 

(1,977)

Other current assets

 

 

 

(236)

 

 

(538)

Accounts payable

 

 

 

131 

 

 

1,128 

Accrued liabilities

 

 

 

(5,673)

 

 

(2,196)

Other noncurrent assets and liabilities

 

 

 

(338)

 

 

128 

Net cash used in operating activities

 

 

 

(16,956)

 

 

(6,394)

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchases of available-for-sale securities

 

 

 

(21,940)

 

 

(10,302)

Sales and maturities of available-for-sale securities

 

 

 

12,404 

 

 

20,460 

Purchases of property and equipment

 

 

 

(4,341)

 

 

(4,077)

Increases in property under build-to-suit obligation

 

 

 

 —

 

 

(4,806)

Net cash (used in) provided by investing activities

 

 

 

(13,877)

 

 

1,275 

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from debt borrowings

 

 

 

25,000 

 

 

 —

Payments on capital leases

 

 

 

(218)

 

 

(25)

Increases in build-to-suit obligation

 

 

 

 —

 

 

4,806 

Payment of debt fees

 

 

 

(120)

 

 

(62)

Proceeds from stock option exercises

 

 

 

2,301 

 

 

1,854 

Shares repurchased for payment of taxes on stock awards

 

 

 

(1,033)

 

 

(572)

Proceeds from issuance of common stock under employee stock purchase plan

 

 

 

987 

 

 

906 

Net cash provided by financing activities

 

 

 

26,917 

 

 

6,907 

Effect of exchange rate changes on cash and cash equivalents

 

 

 

69 

 

 

(185)

Net (decrease) increase in cash and cash equivalents

 

 

 

(3,847)

 

 

1,603 

Cash and cash equivalents—beginning of period

 

 

 

23,764 

 

 

28,384 

Cash and cash equivalents—end of period

 

 

$

19,917 

 

$

29,987 

Supplemental cash flow information:

 

 

 

 

 

 

 

Cash paid for interest

 

 

$

577 

 

$

Cash paid for income taxes

 

 

 

 —

 

 

20 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

Accrued purchases of property and equipment

 

 

 

306 

 

 

1,652 

Assets acquired through capital lease

 

 

 

43 

 

 

36 

Capital lease asset early termination

 

 

 

 

 

 —



See accompanying notes to condensed consolidated financial statements.



 

5


 

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—AtriCure, Inc. was incorporated in the State of Delaware on October 31, 2000. The “Company” or “AtriCure” consists of AtriCure, Inc. and its wholly-owned subsidiaries. The Company is a  leading atrial fibrillation (Afib) solutions partner providing innovative products, professional education and support for clinical science to reduce the economic and social burden of atrial fibrillation. The Company sells its products to medical centers globally through a 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 of the 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 normally 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 fiscal 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, 2015 filed with the SEC. 

Principles of Consolidation—The Condensed Consolidated Financial Statements include the accounts of the Company, AtriCure, LLC, Endoscopic Technologies, LLC and nContact Surgical, LLC, the Company’s wholly-owned subsidiaries, all organized in the State of Delaware, AtriCure Europe B.V. (AtriCure Europe), the Company’s wholly-owned subsidiary incorporated in the Netherlands and AtriCure Hong Kong Limited, the Company’s wholly-owned subsidiary incorporated in Hong Kong. All intercompany accounts and transactions have been eliminated in consolidation.

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

Investments—The Company places its investments primarily in U.S. Government agencies and securities, corporate bonds and commercial paper. The Company 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 (loss). The Company recognizes gains and losses when these securities are sold using the specific identification method and includes them in interest income or expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

Revenue Recognition—The Company accounts for revenue in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 605, “Revenue Recognition” (ASC 605). The Company recognizes revenue when all of the following criteria are met: (i) there is persuasive evidence that an arrangement exists; (ii) delivery of the products and/or services has occurred; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably assured.

Pursuant to the Company’s standard terms of sale, revenue is recognized when title to the goods and risk of loss transfers to customers and there are no remaining obligations that will affect the customers’ final acceptance of the sale. Generally, the Company’s standard terms of sale define the transfer of title and risk of loss to occur upon shipment to the respective customer. The Company does not normally maintain any post-shipping obligations to the recipients of the products. No installation, calibration or testing of products is performed by the Company subsequent to shipment to the customer in order to render it operational.

Revenue includes shipping and handling revenue of $329 and $271 for the three months ended June 30, 2016 and 2015, and $625 and $518 for the six months ended June 30, 2016 and 2015, respectively. Cost of freight for shipments made to customers is included in cost of revenue. Sales and other value-added taxes collected from customers and remitted to governmental authorities are excluded from revenue. The Company sells its products primarily through a direct sales force, with certain international markets sold through distributors. 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. 

Sales Returns and Allowances—The Company maintains a provision for sales returns and allowances to account for potential returns of defective or damaged products, products shipped in error and invoice adjustments. The Company estimates such provision on a quarterly basis based primarily on specific identification, in addition to estimating a general reserve based on 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.

6


 

Table of Contents

ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

Allowance for Doubtful Accounts Receivable—The Company evaluates the collectability of accounts receivable to determine the appropriate reserve for doubtful accounts. In determining the amount of the reserve, the Company considers aging of account balances, historical credit losses, customer-specific information and other relevant factors. An increase to the allowance for doubtful accounts results in a corresponding increase in selling, general and administrative expense. The Company reviews accounts receivable and 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 market using approximate costs based on the first-in, first-out cost method (FIFO). Inventories consist of raw materials, work in process and finished goods. The Company’s industry is characterized by rapid product development and frequent new product introductions. Uncertain timing of product approvals, variability in product launch strategies and variation in product utilization all impact excess and obsolete inventory. An inventory allowance based on product usage is estimated and recorded quarterly for excess, slow moving and obsolete inventory, as well as inventory with a carrying value in excess of its net realizable value. An increase to the inventory reserve allowance results in a corresponding increase in cost of revenue. Write-offs are recorded when a product is destroyed. The Company’s history of write-offs against the reserve has not been significant.

Inventories consist of the following:







 

 

 

 

 

 



 

 

 

 

 

 



 

June 30,

 

December 31,



 

2016

 

2015

Raw materials

 

$

5,581 

 

$

6,159 

Work in process

 

 

1,418 

 

 

974 

Finished goods

 

 

12,312 

 

 

10,526 

Inventories

 

$

19,311 

 

$

17,659 

Property and Equipment—Property and equipment is stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method of depreciation for financial reporting purposes and is applied over the estimated useful lives of the assets. The estimated useful life by major asset category is the following: generators and other capital equipment, machinery, equipment and vehicles is three to seven years, computer and other office equipment is three years, furniture and fixtures is three to seven years and leasehold improvements and equipment under capital leases are the shorter of their useful life or remaining lease term. The Company reassesses the useful lives of property and equipment annually, and assets are retired if they are no longer in service. Maintenance and repair costs are expensed as incurred.

Generators and other capital equipment (such as the Company’s switchbox units and cryosurgical consoles) are placed with direct customers that use the Company’s disposable products. Depreciation of such assets is included in cost of revenue. The estimated useful lives of this equipment are based on anticipated usage by customers and the timing and impact of expected new technology rollouts by the Company. To the extent the Company experiences changes in the usage of this equipment or introduces new technologies, the estimated useful lives of this equipment may change in a future period. Depreciation related to these generators was $879 and $673 for the three months ended June 30, 2016 and 2015, respectively, and $1,715 and $1,293 for the six months ended June 30, 2016 and 2015, respectively. As of June 30, 2016 and December 31, 2015, the net carrying amount of loaned equipment included in net property and equipment in the Condensed Consolidated Balance Sheets was $5,454 and $5,447, respectively.

The Company reviews property and equipment for impairment using its best estimates based on reasonable and supportable assumptions and projections.

Intangible Assets—Intangible assets with determinable useful lives are amortized on a straight-line basis over the estimated periods benefited.

Included in intangible assets is In Process Research and Development (IPR&D). The Company defines IPR&D as the value of acquired technology which has not yet reached technological feasibility. The primary basis for determining the technological feasibility is obtaining specific regulatory approvals. The estimated fair value of IPR&D acquired in a business combination is capitalized as an indefinite-lived intangible asset until completion or abandonment of the IPR&D project. Upon completion of the development project, the IPR&D is amortized over its estimated useful life. If the IPR&D project is abandoned, the related IPR&D asset is written off. The estimated fair value of IPR&D was determined using an income approach model and represents an estimate of the fair value of the PMA approval that could result from the CONVERGE IDE clinical trial.

The Company reviews intangible assets for impairment using its best estimates based on reasonable and supportable assumptions and projections.

7


 

Table of Contents

ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

Goodwill—Goodwill represents the excess of purchase price over the fair value of the net assets acquired in business combinations. The Company tests 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 as a whole.

Other Noncurrent Liabilities—Other noncurrent liabilities include contingent consideration recorded in business combinations, as well as long-term deferred revenues and other contractual obligations.

Other IncomeOther income consists primarily of foreign currency transaction gains and losses. The Company recorded net foreign currency transaction losses of $35 and $46 for the three months ended June 30, 2016 and 2015, respectively, and $115 and $209 for the six months ended June 30, 2016 and 2015, respectively, in connection with settlements of its intercompany balance with AtriCure Europe and sales invoices transacted in British Pounds.

Taxes—Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred 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 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 tax assets requires it to make significant estimates and judgments about its future operating results. Deferred tax assets are reduced by valuation allowances if, based on the consideration of all available evidence, it is more-likely-than-not that some portion of the deferred tax asset will not be realized. Significant weight is given to evidence that can be objectively verified. The Company evaluates deferred tax assets on a quarterly basis to determine if valuation allowances are required by considering all available evidence. Deferred 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 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 whether to record a valuation allowance, the applicable accounting standards deem that the existence of cumulative losses in recent years is a significant piece of 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 its net deferred tax assets as it is more likely than not that the benefit of the deferred tax assets will not be recognized in future periods.

A provision of The Patient Protection and Affordable Care Act enacted in 2010, as amended (Patient Act), required manufacturers of medical devices to pay an excise tax on all U.S. medical device sales. In December 2015, the U.S. government approved the suspension of the excise tax on medical device sales beginning January 1, 2016 through December 31, 2017. The Company’s expense related to the medical device excise tax, which was recorded in cost of revenue, was $0 and $149 for the three months ended June 30, 2016 and 2015, respectively, and $0 and $304 for the six months ended June 30, 2016 and 2015, respectively.

Net Loss Per Share—Basic and diluted net loss per share is computed in accordance with FASB ASC 260, “Earnings Per Share” (ASC 260) 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 4,471 and 4,290 stock options and restricted stock shares as of June 30, 2016 and 2015, respectively, 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 Loss—In addition to net losses, the comprehensive loss includes foreign currency translation adjustments and unrealized gains and losses on investments.

8


 

Table of Contents

ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

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







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2016

 

2015

 

2016

 

2015

Total accumulated other comprehensive loss at

  beginning of period

 

$

(284)

 

$

(798)

 

$

(611)

 

$

(348)

Unrealized Gains on Investments

 

 

 

 

 

 

 

 

 

 

 

 

Balance at beginning of period

 

$

 

$

(17)

 

$

(39)

 

$

(54)

Other comprehensive income (loss) before reclassifications

 

 

13 

 

 

 

 

54 

 

 

39 

Amounts reclassified from accumulated other comprehensive

  income to other income on the statement of operations

 

 

 —

 

 

 —

 

 

 —

 

 

 —

Balance at end of period

 

$

15 

 

$

(15)

 

$

15 

 

$

(15)

Foreign Currency Translation Adjustment

 

 

 

 

 

 

 

 

 

 

 

 

Balance at beginning of period

 

$

(286)

 

$

(781)

 

$

(572)

 

$

(294)

Other comprehensive income (loss) before reclassifications

 

 

(229)

 

 

392 

 

 

52 

 

 

68 

Amounts reclassified from accumulated other comprehensive

  income to other income on the statement of operations

 

 

10 

 

 

(139)

 

 

15 

 

 

(302)

Balance at end of period

 

$

(505)

 

$

(528)

 

$

(505)

 

$

(528)

Total accumulated other comprehensive loss at end of period

 

$

(490)

 

$

(543)

 

$

(490)

 

$

(543)

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

Advertising Costs The Company expenses advertising costs as incurred. Advertising costs were not significant during the three and six months ended June 30, 2016 and 2015.

Share-Based Compensation—The Company follows FASB ASC 718, “Compensation-Stock Compensation” (ASC 718) to record share-based compensation for all employee share-based payment awards, including stock options, restricted stock and stock purchases related to an employee stock purchase plan, based on estimated fair values. The Company’s share-based compensation expense recognized under ASC 718 for the three months ended June 30, 2016 and 2015 was $3,027 and $2,417, respectively, and $5,869 and $4,141, respectively, for the six months ended June 30, 2016 and 2015, on a before and after tax basis.

ASC 718 requires companies to estimate the fair value of share-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s Condensed Consolidated Statement of Operations and Comprehensive Loss. The expense has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

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 of share-based payment awards on the date of grant using an option-pricing model is affected by the Company’s stock price, as well as assumptions regarding a number of 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 fair value of market-based performance option grants is estimated at the date of grant using a Monte-Carlo simulation. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Consolidated Statement of Operations and Comprehensive Loss.

The Company estimates the fair value of restricted stock based upon the grant date closing market price of the Company’s common stock. The Company’s determination of fair value is affected by the Company’s stock price as well as assumptions regarding the number of shares expected to be granted.

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 and records compensation expense based upon the fair value of the stock at the beginning of the purchase period using the Black-Scholes model.

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ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

Use of Estimates—The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Actual results could differ from those estimates.

Fair Value Disclosures—The Company classifies and records cash and investments in U.S. government agencies and securities as Level 1 within the fair value hierarchy. Accounts receivable, short-term other assets, accounts payable and accrued liabilities are also classified as Level 1. 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 and commercial paper are classified as Level 2 within the fair value hierarchy (see Note 3 – Fair Value for further information). The book value of the Company’s fixed interest rate debt approximates its fair value as of June 30, 2016. Fixed interest rate debt fair value is determined by calculating the net present value of future debt payments and is classified as Level 2. Significant unobservable inputs with respect to the Level 3 fair value measurement of the contingent consideration liability is developed using Company data. When an input is changed, the corresponding valuation models are updated and the results are analyzed for reasonableness.

 

2. RECENT ACCOUNTING PRONOUNCEMENTS

In May 2014 the FASB issued a final standard on revenue from contracts with customers. The standard, issued as FASB ASU 2014-09, “Revenue from Contracts with Customers” (ASU 2014-09), outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. In July 2015 the FASB decided to defer the effective date of ASU 2014-09 for entities reporting under U.S. GAAP from interim and annual reporting periods beginning after December 15, 2016 to interim and annual reporting periods beginning after December 15, 2017 and allow early adoption as of the original effective date. A full retrospective or modified retrospective approach may be taken to adopt the guidance in the ASU. FASB ASU 2016-08, Revenue from Contracts with Customers (Topic 606): Principal Versus Agent Considerations (Reporting Revenue Gross Versus Net)”, FASB ASU 2016-10, “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing”, and FASB ASU 2016-12, “Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients”, have been issued in 2016 to further refine the guidance in ASU 2014-09. The Company is evaluating the impact of the provisions of the revenue-related ASUs on its consolidated financial position, results of operations and related disclosures.

In November 2015 the FASB issued ASU 2015-17, “Income Taxes (Topic 740), Balance Sheet Classification of Deferred Taxes” (ASU 2015-17), which requires companies to classify all deferred tax assets and liabilities as noncurrent on the balance sheet instead of separating deferred taxes into current and noncurrent amounts. Also, companies will no longer allocate valuation allowances between current and noncurrent deferred tax assets because those allowances also will be classified as noncurrent. ASU 2015-17 is effective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted for financial statements that have not been issued. The Company has evaluated the impact of the provisions of ASU 2015-17 on its consolidated financial position and related disclosures and has determined that the new guidance does not have a material impact on its financial reporting.

In January 2016 the FASB issued ASU 2016-01, “Financial Instruments — Overall — Recognition and Measurement of Financial Assets and Financial Liabilities” (ASU 2016-01), which amends the guidance in U.S. GAAP on the classification and measurement of financial instruments. Although the ASU retains many current requirements, it significantly revises an entity’s accounting related to (1) the classification and measurement of investments in equity securities and (2) the presentation of certain fair value changes for financial liabilities measured at fair value. The ASU also amends certain disclosure requirements associated with the fair value of financial instruments. The new standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2017. The Company is evaluating the impact of ASU 2016-01 on its consolidated financial position and related disclosures.

In February 2016 the FASB issued ASU 2016-02, “Leases” (ASU 2016-02) 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 fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Entities are 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 is evaluating the provisions of ASU 2016-02 to determine the impact on its consolidated financial position and related disclosures.  

In March 2016 the FASB issued ASU 2016-09, “Improvements to Employee Share-Based Payment Accounting” (ASU 2016-09), which changes certain aspects of accounting for share-based payments to employees. The new guidance requires all income tax effects of awards to be recognized in the income statement when the awards vest or are settled. It also allows an employer to

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ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting and to make a policy election to account for forfeitures as they occur rather than apply an estimate for expense recognition. ASU 2016-09 is effective for fiscal years beginning after December 15, 2016, and interim periods within those years. Early adoption is permitted, however, all of the guidance within the ASU must be adopted in the same period. The Company is evaluating the impact of ASU 2016-09 on its consolidated financial position, results of operations and related disclosures.

In June 2016 the FASB issued ASU 2016-13, “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments” (ASU 2016-13), which changes how entities will measure credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. The standard replaces today’s “incurred loss” approach with an “expected loss” model for instruments measured at amortized cost and requires entities to record allowances for available-for-sale debt securities rather than reduce the carrying amount, as they do today under the other-than-temporary impairment model. It also simplifies the accounting model for purchased credit-impaired debt securities and loans. ASU 2016-13 is effective for annual periods beginning after December 15, 2019, and interim periods therein. Early adoption is permitted for annual periods beginning after December 15, 2018, and interim periods therein. The Company is evaluating the impact of ASU 2016-13 on its consolidated financial position, results of operations and related disclosures.

 

3. FAIR VALUE

FASB ASC 820, “Fair Value Measurements and Disclosures” (ASC 820) defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy 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 which are the following:

·

Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. An active market for the asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. The valuation under this approach does not entail a significant degree of judgment.

·

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. The valuation technique for the Company’s Level 2 assets is based on quoted market prices for similar assets from observable pricing sources at the reporting date.

·

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. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. The fair value of the Company’s contingent consideration liability was estimated on the acquisition date of nContact Surgical, Inc. (nContact) using Level 3 inputs.

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ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

In accordance with ASC 820, 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, 2016:  







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

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

 

$

 

$

13,763 

 

$

 

$

13,763 

U.S. government agencies and securities

 

 

5,582 

 

 

 

 

 

 

5,582 

Corporate bonds

 

 

 

 

10,499 

 

 

 

 

10,499 

Commercial paper

 

 

 

 

11,954 

 

 

 

 

11,954 

Total assets

 

$

5,582 

 

$

36,216 

 

$

 

$

41,798 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Acquisition-related contingent consideration

 

 

 

 

 

 

40,207 

 

 

40,207 

Total liabilities

 

$

 

$

 

$

40,207 

 

$

40,207 

There were no changes in the levels or methodology of measurement of financial assets and liabilities during the three or six month periods ended June 30, 2016.

In accordance with ASC 820, 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, 2015:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

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

 

$

 —

 

$

18,572 

 

$

 —

 

$

18,572 

U.S. government agencies and securities

 

 

1,590 

 

 

 —

 

 

 —

 

 

1,590 

Corporate bonds

 

 

 —

 

 

16,930 

 

 

 —

 

 

16,930 

Total assets

 

$

1,590 

 

$

35,502 

 

$

 —

 

$

37,092 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Acquisition-related contingent consideration

 

 

 —

 

 

 —

 

 

40,207 

 

 

40,207 

Total liabilities

 

$

 —

 

$

 —

 

$

40,207 

 

$

40,207 



There were no changes in the levels or methodology of measurement of financial assets and liabilities during the twelve months ended December 31, 2015.

 Acquisition-Related Contingent Consideration. Contingent consideration arrangements obligate the Company to pay former shareholders of an acquired entity if specified future events occur or conditions are met, such as the achievement of certain technological milestones or the achievement of targeted revenue milestones. The Company measures such liabilities using unobservable inputs, applying the 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 Company acquired nContact on October 13, 2015. The aggregate consideration paid to nContact shareholders includes up to $50,000 in contingent consideration based on completion of enrollment of the CONVERGE IDE trial and corresponding PMA approval by December 31, 2020. nContact shareholders are entitled to additional contingent consideration based on specified product

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

revenue in excess of an annual growth rate of more than 25% through 2019. There were no changes in the estimates or discount rate during the three or six months ended June 30, 2016.

The following table represents the Company’s Level 3 fair value measurements using significant other unobservable inputs for acquisition-related contingent consideration as of June 30, 2016:

   



 

 

 



 

 

 

Beginning Balance – January 1, 2016

 

$

40,207 

Amounts acquired

 

 

 —

Transfers in (out) of Level 3

 

 

 —

Changes in fair value included in earnings

 

 

 —

Ending Balance – June 30, 2016

 

$

40,207 

The following table represents the Company’s Level 3 fair value measurements using significant other unobservable inputs for acquisition-related contingent consideration as of December 31, 2015:    







 

 

 



 

 

 

Beginning Balance – January 1, 2015

 

$

 —

Amounts acquired

 

 

40,207 

Transfers in (out) of Level 3

 

 

 —

Changes in fair value included in earnings

 

 

 —

Ending Balance – December 31, 2015

 

$

40,207 

 



4. INTANGIBLE ASSETS

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







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

June 30,

 

December 31,



 

2016

 

2015



 

Cost 

 

Accumulated

Amortization

 

Cost

 

Accumulated

Amortization



 

 

 

 

 

 

 

 

 

 

 

 

Non-compete agreement

 

$

100 

 

$

100 

 

$

100 

 

$

100 

Fusion technology

 

 

9,242 

 

 

2,310 

 

 

9,242 

 

 

1,848 

Clamp & probe technology

 

 

829 

 

 

691 

 

 

829 

 

 

552 

Estech trade name

 

 

208 

 

 

208 

 

 

208 

 

 

208 

SUBTLE access technology

 

 

2,179 

 

 

317 

 

 

2,179 

 

 

96 

IPR&D

 

 

44,021 

 

 

 —

 

 

44,021 

 

 

 —

Total

 

$

56,579 

 

$

3,626 

 

$

56,579 

 

$

2,804 



Amortization expense related to intangible assets with definite lives, which excludes the IPR&D asset, was $411 and $303 for the three months ended June 30, 2016 and 2015, respectively, and $822 and $606 for the six months ended June 30, 2016 and 2015, respectively.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

Future amortization expense related to intangible assets with definite lives is projected as follows:







 

 

 

 

 



 

 

 

 

 

2016

 

$

822 

 

July 1, 2016 through December 31, 2016

2017

 

 

1,367 

 

 

2018

 

 

1,367 

 

 

2019

 

 

1,367 

 

 

2020

 

 

1,235 

 

 

2021 and thereafter

 

 

2,774 

 

 

Total

 

$

8,932 

 

 

 



5. ACCRUED LIABILITIES

Accrued liabilities consisted of the following:







 

 

 

 

 

 



 

 

 

 

 

 



 

June 30,

 

December 31,



 

2016

 

2015

Accrued payroll and employee-related expenses

 

$

3,381 

 

$

4,021 

Accrued commissions

 

 

3,772 

 

 

6,061 

Accrued taxes and value-added taxes payable

 

 

859 

 

 

912 

Accrued bonus

 

 

3,177 

 

 

6,088 

Other accrued liabilities

 

 

936 

 

 

723 

Accrued royalties

 

 

402 

 

 

382 

Sales returns allowance

 

 

263 

 

 

207 

Total

 

$

12,790 

 

$

18,394 

 





6. INDEBTEDNESS

Bank Credit Facility. The Company has a debt agreement (Loan Agreement) with Silicon Valley Bank (SVB). The Loan Agreement, as amended, restated and modified, effective April 25, 2016, includes a $25,000 term loan and $15,000 revolving line of credit, both which mature in  April 2021. Borrowing availability under the revolving credit facility is based on the lesser of $15,000 or a borrowing base calculation as defined by the Loan Agreement. As of June 30, 2016 the Company had no borrowings under the revolving credit facility and had borrowing availability of $15,000. The revolving line of credit is subject to an annual commitment fee of $50, and any borrowings bear interest at the Prime Rate. 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 term of the Loan Agreement.

The term loan has a five-year term, with principal payments to be made ratably commencing twelve months after the inception of the loan through to 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 Prime Rate and is subject to an additional 4.0% fee on the original $25,000 term loan principal amount at maturity or prepayment of the term loan that is being accrued over the term of the Loan Agreement. The Company has accrued $53 of this fee as of June 30, 2016. Financing costs related to the term loan are net against the outstanding loan balance in the Condensed Consolidated Balance Sheets and amortized ratably over the term of the Loan Agreement.

The Loan Agreement also provides for certain prepayment and early termination fees, as well as establishes covenants related to liquidity, sales growth and a minimum cash balance, and includes other customary terms and conditions. Specified assets have been pledged as collateral.

Capital Lease Obligations. As of June 30, 2016 the Company had capital leases for its corporate headquarters building and computer equipment that expire at various terms through 2030.  

In August 2014 the Company entered into a new building lease (Mason Lease) in order to re-locate its corporate headquarters and West Chester, Ohio facilities from their current location to a building to be constructed in Mason, Ohio. The term of the Mason Lease is fifteen years with three separate five-year renewal options, at the Company’s option, and commenced in October 2015. On the Commencement Date, the Company provided a letter of credit to the Landlord in the amount of $1,250, which amount may decrease or be removed entirely based on the Company’s financial performance. The Company was deemed the owner of the project

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

during the construction period. As a result, project costs incurred during construction of the building were included in property and equipment as construction in progress and the corresponding financing obligation was included in other current liabilities during the construction period.  Increases in purchases of building under construction and proceeds from the construction financing obligation were also included in the Condensed Consolidated Statement of Cash Flows during the construction period. Upon completion of construction, the Company recorded the current and noncurrent portions of the Mason Lease obligation within capital leases and the value of the underlying asset in property and equipment in the Condensed Consolidated Balance Sheet.  

At June 30, 2016 the cost of the leased assets, both building and computer equipment, was $14,486. The assets are depreciated over their estimated useful lives, which equal the terms of the leases. Accumulated amortization on the capital leases was $832 at June 30, 2016.  

Future maturities on capital lease obligations are projected as follows:







 

 

 

 

 



 

 

 

 

 

2016

 

$

1,072 

 

July 1, 2016 through December 31, 2016

2017

 

 

1,434 

 

 

2018

 

 

1,448 

 

 

2019

 

 

1,466 

 

 

2020

 

 

1,488 

 

 

2021 and thereafter

 

 

15,899 

 

 

Total payments

 

$

22,807 

 

 

Imputed interest

 

 

(8,830)

 

 

Net capital lease obligations, of which $473 is current and $13,504 is noncurrent

 

$

13,977 

 

 

 



7. COMMITMENTS AND CONTINGENCIES

Lease Commitments. The Company leases certain office, manufacturing and warehouse facilities and equipment under noncancelable operating leases that expire at various terms through 2021.  

Royalty Agreements.  The Company has certain royalty agreements in place with terms that include payment of royalties based on product revenue from sales of specified current products. The royalty agreements have effective dates as early as 2003 and terms ranging from three years to at least twenty years. The royalties range from 0.75% to 5% of specified product sales. Parties to the royalty agreements have the right at any time to terminate the agreement immediately for cause. Royalty expense of $445 and $471 was recorded as part of cost of revenue for the three months ended June 30, 2016  and 2015, respectively. Royalty expense of $886 and $898 was recorded as part of cost of revenue for the six months ended June 30, 2016 and 2015, respectively.

Purchase Agreements. The Company enters into standard purchase agreements with certain vendors in the ordinary course of business. Outstanding commitments at June 30, 2016 and 2015 were not significant.

Legal.  The Company is not currently party to any material pending or threatened litigation. The Company may, from time to time, become a party to legal proceedings.

 

8. INCOME TAX PROVISION

The Company files federal, state, and foreign income tax returns in jurisdictions with varying statutes of limitations. Income taxes are computed using the asset and liability method in accordance with FASB ASC 740, “Income Taxes”, under which deferred income taxes are provided for the temporary differences between the financial reporting basis and the tax basis of the Company’s assets and liabilities. Deferred taxes are measured using provisions of currently enacted tax laws. A valuation allowance against deferred tax assets is recorded when it is more-likely-than-not that such assets will not be fully realized. The Company has recorded a full valuation allowance against its net deferred tax assets as it is more-likely-than-not that the benefit of the deferred tax assets will not be recognized in future periods. Tax credits are accounted for as a reduction of income taxes in the year in which the credit originates.

The Company’s provision for income taxes for continuing operations in interim periods is computed by applying its estimated annual effective rate against its loss before income tax (expense) benefit for the period. In addition, non-recurring or discrete items are recorded during the period in which they occur. The effective tax rate for the three months ended June 30, 2016 and 2015 was

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

(0.20%) and (0.17%), respectively. The effective tax rate for the six months ended June 30, 2016 and 2015 was (0.12%) and (0.14%), respectively.

The Company has not had to accrue 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 the income tax expense (benefit) line in the Condensed Consolidated Statements of Operations and Comprehensive Loss and within the related tax liability line in the Condensed Consolidated Balance Sheets. Federal, state and local tax returns of the Company are routinely subject to review by various taxing authorities. The Internal Revenue Service is currently reviewing the Company’s 2014 federal tax return.

 

9. EQUITY COMPENSATION PLANS

The Company has several share-based incentive plans: the 2005 Equity Incentive Plan (2005 Plan), the Second Amended and Restated 2014 Stock Incentive Plan (2014 Plan) and the 2008 Employee Stock Purchase Plan (ESPP).

Equity Incentive Plans

The Company granted awards under the 2005 Plan until the 2014 Annual Meeting of Stockholders at which stockholders adopted the 2014 Plan. Pursuant to its terms, the 2014 Plan supersedes and replaces the 2005 Plan. Under the 2014 Plan, the Board of Directors may grant incentive stock options to employees and any parent or subsidiary’s employees, and may grant nonstatutory stock options, restricted stock or stock appreciation rights to employees, directors and consultants of the Company and any parent or subsidiary’s employees, directors and consultants. The administrator (currently the Compensation Committee of the Board of Directors) has the power 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, 2016, 9,399 shares of common stock had been reserved for issuance under the 2014 Plan.

Options granted under the plans generally expire ten years from the date of grant. Options granted from the 2005 Plan and 2014 Plan 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 under the 2005 Plan and 2014 Plan generally vest 25% annually over four years from date of grant.

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 (currently 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 more than $25 of the Company’s common stock in a calendar year and may not purchase a value of more than 3 shares during an offering period. Beginning on January 1, 2009 and on the first day of each fiscal year thereafter during the term of the ESPP, the number of shares available for sale under the ESPP shall be increased by the lesser of (i) two percent (2%) of the Company’s outstanding shares of common stock as of the close of business on the last business day of the prior calendar year, not to exceed 600 shares, or (ii) a lesser amount determined by the Board of Directors. At June 30, 2016 there were 408 shares available for future issuance under the ESPP.

Expense Information Under FASB ASC 718

The following table summarizes share-based compensation expense related to employees under FASB ASC 718 for the three and six months ended June 30, 2016 and 2015. This expense was allocated as follows:

16


 

Table of Contents

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,



 

2016

 

2015

 

2016

 

2015

Cost of revenue

 

$

88 

 

$

106 

 

$

227 

 

$

196 

Research and development expenses

 

 

443 

 

 

347 

 

 

922 

 

 

636 

Selling, general and administrative expenses

 

 

2,496 

 

 

1,964 

 

 

4,720 

 

 

3,309 

Total share-based compensation expense related to

  employees

 

$

3,027 

 

$

2,417 

 

$

5,869 

 

$

4,141 

 



10. SEGMENT AND GEOGRAPHIC INFORMATION

The Company evaluates reporting segments in accordance with FASB ASC 280, “Segment Reporting”. 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 in the United States and internationally. Management considers all such sales to be part of a single reportable segment. Revenue attributed to geographic areas is based on the location of the customers to whom products are sold.

Revenue by geographic area was as follows:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2016

 

2015

 

2016

 

2015

United States

 

$

30,872 

 

$

25,744 

 

$

59,144 

 

$

48,667 

Europe

 

 

5,408 

 

 

4,122 

 

 

10,169 

 

 

8,538 

Asia

 

 

3,262 

 

 

2,538 

 

 

5,990 

 

 

4,838 

Other international

 

 

130 

 

 

179 

 

 

309 

 

 

426 

Total international

 

 

8,800 

 

 

6,839 

 

 

16,468 

 

 

13,802 

Total revenue

 

$

39,672 

 

$

32,583 

 

$

75,612 

 

$

62,469 



Domestic revenue by product type was as follows:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2016

 

2015

 

2016

 

2015

Open-heart ablation

 

$

14,721 

 

$

13,648 

 

$

28,689 

 

$

26,002 

Minimally invasive ablation

 

 

7,990 

 

 

5,057 

 

 

14,715 

 

 

9,404 

AtriClip

 

 

7,348 

 

 

6,286 

 

 

14,196 

 

 

11,789 

Total ablation and AtriClip

 

 

30,059 

 

 

24,991 

 

 

57,600 

 

 

47,195 

Valve tools

 

 

813 

 

 

753 

 

 

1,544 

 

 

1,472 

Total domestic

 

$

30,872 

 

$

25,744 

 

$

59,144 

 

$

48,667 



17


 

Table of Contents

ATRICURE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except per share amounts)

(Unaudited)

 

International revenue by product type was as follows:







 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2016

 

2015

 

2016

 

2015

Open-heart ablation

 

$

5,438 

 

$

4,088 

 

$

9,910 

 

$

8,304 

Minimally invasive ablation

 

 

2,186 

 

 

1,858 

 

 

4,350 

 

 

3,826 

AtriClip

 

 

1,024 

 

 

789 

 

 

1,889 

 

 

1,460 

Total ablation and AtriClip

 

 

8,648 

 

 

6,735 

 

 

16,149 

 

 

13,590 

Valve tools

 

 

152 

 

 

104 

 

 

319 

 

 

212 

Total international

 

$

8,800 

 

$

6,839 

 

$

16,468 

 

$

13,802 



The majority of the Company’s long-lived assets are located in the United States.

 

 

18


 

 

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, 2015 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, 2015. 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 atrial fibrillation (Afib) solutions partner providing innovative products, professional education and support for clinical science to reduce the economic and social burden of atrial fibrillation. 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. Our AtriClip® Left Atrial Appendage Exclusion System is the most widely sold device worldwide specifically designed to occlude the heart’s left atrial appendage (LAA). We believe cardiothoracic surgeons are adopting our ablation and LAA management (LAAM) devices for the treatment of Afib and reduction of Afib-related complications such as stroke.

Cardiothoracic surgeons have adopted our radiofrequency ablation and cryoablation systems to treat Afib in over 200,000 patients since 2004, and we believe that we are currently the market leader in the surgical treatment of Afib. Our products are utilized by cardiothoracic surgeons during both open-heart and minimally invasive surgical procedures, either on a concomitant or sole-therapy basis. During a concomitant procedure, the surgeon ablates cardiac tissue and/or occludes the left atrial appendage, secondary, or concomitant, to a primary cardiac procedure such as a valve repair or replacement or coronary artery bypass graft (CABG). Our Isolator Synergy System, which includes our Isolator Synergy clamps, RF generator and related switchbox, is approved by FDA for the treatment of persistent and long-standing persistent Afib concomitant to other open-heart surgical procedures such as coronary artery bypass grafting and/or valve replacement or repair. To date, none of our other products have been approved or cleared by FDA specifically for the treatment of Afib.  Our 510(k)-cleared RF and cryo ablation products are indicated for the ablation of cardiac tissue and/or treatment of cardiac arrhythmias. In addition, our cryoICE® probe is cleared for blocking pain by temporarily ablating peripheral nerves. Our AtriClip products are 510(k)-cleared with an indication for occlusion of the LAA, under direct visualization, concomitant to other open cardiac surgical procedures. In October 2015 we acquired nContact, a leader in minimally invasive technology for epicardial ablation. We also have a line of reusable surgical instruments typically used for cardiac valve replacement or repair. 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, which surgeons use to ablate cardiac tissue, to occlude the left atrial appendage, to perform mitral and aortic valve replacement and repair and/or to ablate peripheral nerves during cardiothoracic surgery.

In the United States we sell our products to medical centers through our direct sales force. In certain international markets, such as Germany, France, the United Kingdom and the Benelux region, sales are made directly to medical centers, with the remaining international sales being made through distributors who in turn sell our products to end users. Our business is primarily transacted in U.S. Dollars with the exception of transactions with our European subsidiary which are transacted in Euros or British Pounds.

19


 

Recent Developments

We submitted an Investigational Device Exemption (IDE) application for the Staged DEEP AF pivotal trial to FDA in May 2014. The Staged 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. FDA approval to enroll up to 220 subjects at 23 domestic medical centers and two international medical centers was received during the third quarter of 2014. Enrollment began during the first quarter of 2015, and there are currently 41 patients enrolled and thirteen sites initiated. Enrollment has been temporarily suspended while we evaluate changes to the trial protocol with FDA.

We are in the beginning stages of our ATLAS study, which 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. At full capacity, we expect to enroll approximately 2,000 patients at up to twenty sites. We began enrollment in February 2016, and there are currently 47 patients enrolled and six sites initiated.

We are in the beginning stages of our cryoanalgesia study (FROST), 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 current standard of care. The study will involve treatment arm subjects who will receive intercostal cryoanalgesia in conjunction with standard post-operative pain management and control arm subjects who will receive standard post-operative pain management only. At full capacity, we expect to enroll 100 patients at up to five sites. We began enrollment in June 2016, and there are currently 2 patients enrolled and two sites initiated. 

We are also pursuing a non-IDE trial in Europe, CEASE AF, 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.  We expect the study to have an enrollment of approximately 210 patients across ten sites. There are currently 24 patients enrolled and eight sites initiated.

With the acquisition of nContact, we are conducting the CONVERGE IDE clinical trial. The CONVERGE pivotal trial evaluates 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. We have FDA approval to enroll up to 153 subjects at fifteen domestic medical centers and two international medical centers.  We recently received approval from FDA to increase the number of trial sites to 27 domestic medical centers and three international medical centers. Enrollment began during the first quarter of 2014, and there are currently 49 patients enrolled and thirteen domestic sites initiated.

We announced the launch of the AtriClip PRO2 LAA Exclusion System in the United States in April 2016. The new AtriClip PRO2 system has increased functionality which enhances the capability to occlude the LAA during minimally-invasive surgical (MIS) procedures. The AtriClip PRO2 system features an ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector. The ambidextrous locking and trigger-style clip closing mechanism allows the operator to maintain focus on the LAA while maneuvering the device. The handle-based active articulation levers allow the operator to steer the end effector without removing the device. The hoopless end effector enhances anatomical visualization, and simplifies removal of the applier after deployment of the clip. The AtriClip PRO2 system received CE Mark in June 2016.

20


 

Results of Operations

Three months ended June 30, 2016 compared to three months ended June 30, 2015 

The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts and as percentages of total revenue:





 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 



 

Three Months Ended



 

June 30,



 

2016

 

2015



 

Amount 

 

% of
Revenues

 

Amount 

 

% of
Revenues

Revenue

 

$

39,672 

 

100.0 

%

 

$

32,583 

 

100.0 

%

Cost of revenue

 

 

10,854 

 

27.4 

%

 

 

9,466 

 

29.1 

%

Gross profit

 

 

28,818 

 

72.6 

%

 

 

23,117 

 

70.9 

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

9,124 

 

23.0