-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, S6m9iThkD/+ytJvOmHDB4oU5XJLj3AHUN6yu5M33unlS3AMSp9l6JE0a/4aIBX5F ZqIJUBR0270E1N9td8g5lA== 0001193125-10-243819.txt : 20101102 0001193125-10-243819.hdr.sgml : 20101102 20101102111941 ACCESSION NUMBER: 0001193125-10-243819 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20101102 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101102 DATE AS OF CHANGE: 20101102 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AtriCure, Inc. CENTRAL INDEX KEY: 0001323885 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 341940305 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51470 FILM NUMBER: 101156960 BUSINESS ADDRESS: STREET 1: 6217 CENTRE PARK DRIVE CITY: WEST CHESTER STATE: OH ZIP: 45069 BUSINESS PHONE: 513-755-4107 MAIL ADDRESS: STREET 1: 6217 CENTRE PARK DRIVE CITY: WEST CHESTER STATE: OH ZIP: 45069 8-K 1 d8k.htm CURRENT REPORT Current Report

 

 

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) of the

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 2, 2010

 

 

ATRICURE, INC.

(Exact name of registrant as specified in charter)

 

 

 

Delaware   000-51470   34-1940305

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

6217 Centre Park Drive

West Chester, OH

  45069
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (513) 755-4100

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

On November 2, 2010, the Company issued a press release and is holding a conference call regarding its financial results for the third quarter ended September 30, 2010. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

The information in this Item 2.02 to Form 8-K and in the press release attached as Exhibit 99.1 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in Item 2.02 of this Form 8-K and Exhibit 99.1 shall not be incorporated by reference in any filing or other document under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filing or document.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

No.

  

Description

99.1    Press Release dated November 2, 2010


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    ATRICURE, INC.
Date: November 2, 2010     By:  

/s/ Julie A. Piton

      Julie A. Piton
     

Vice President, Finance and

Administration and Chief Financial Officer

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

 

Exhibit 99.1

LOGO

Contact:

AtriCure, Inc.

Julie A. Piton

Vice President and Chief Financial Officer

(513) 755-4561

jpiton@atricure.com

AtriCure Reports Third Quarter 2010 Financial Results

Third Quarter Highlights

 

   

Revenue of $14.5 million – 10% constant currency growth

 

   

Successful U.S. launch of the AtriClip™ system – sales of $1.0 million

 

   

Gross margin of 77.2% – 190 basis point expansion

 

   

Positive cash from operations of $0.3 million

 

   

Continued positive progress toward ABLATE submission and an AF indication

WEST CHESTER, Ohio – November 2, 2010 – AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, today announced revenue of $14.5 million for its seasonally impacted third quarter of 2010. Revenue from product sales in the United States was $11.6 million, reflecting growth of 8.1 percent and international revenue was $2.9 million, reflecting 19.2 percent growth on a constant currency basis or 12.7 percent on a GAAP basis. Revenue from the AtriClip system in the United States was $1.0 million during the first quarter of full commercial launch.

“We are encouraged by our third quarter momentum and financial results. We believe that our strategic investments in new products, sales force expansion and FDA approvals will continue to accelerate growth. Importantly, we believe that initial sales from the AtriClip system and our new product and regulatory progress affirms the power of our strategic plan,” said David J. Drachman, President and Chief Executive Officer. “During the quarter we made positive progress on our ABLATE clinical module submission, and anticipate filing the final module in support of a PMA during the first quarter of 2011 and receiving an atrial fibrillation approval during 2012. Furthermore, we continue to anticipate initial patient enrollment in our DEEP AF clinical trial during the fourth quarter of 2010.”

Third Quarter Financial Results

Revenue for the third quarter of 2010 was $14.5 million, a $1.2 million increase when compared to third quarter 2009 revenue of $13.3 million. Domestic revenue increased 8.1 percent to $11.6 million. Revenue from domestic open-heart products for the third quarter of 2010, which


includes $1.0 million in revenue from the AtriClip system, increased to $7.9 million from $6.5 million. Revenue from domestic minimally invasive products decreased from $4.2 million for the third quarter of 2009 to $3.7 million for the third quarter of 2010, reflecting fewer procedures. International revenue was $2.9 million for the third quarter of 2010 as compared to $2.6 million for the third quarter of 2009. International growth of 19.2 percent on a constant currency basis was driven primarily by European markets, reflecting growth in both our direct and distributor markets.

Gross profit for the third quarter of 2010 was $11.2 million as compared to $10.0 million for the third quarter of 2009. Gross margin for the third quarter of 2010 was 77.2 percent compared to gross margin of 75.3 percent for the third quarter of 2009. The improvement in gross margin was primarily driven by an increase in gross margin from international sales, driven by a more favorable product mix and a benefit from growth in direct markets. These increases to gross margin were partially offset by an increased mix of revenue from Cryo1 and the AtriClip system, which carry a lower gross margin than our other disposable products.

Operating expenses for the third quarter of 2010 were $12.0 million as compared with third quarter 2009 operating expenses of $14.4 million on a GAAP basis and $10.7 million excluding the settlement reserve. The increase in non-GAAP adjusted operating expenses of $1.3 million was primarily due to increased costs related to clinical activities of $0.4 million and a $1.0 million increase in selling, general and administrative expenses. The increase in selling, general and administrative expenses was due primarily to increased sales and marketing headcount related expenses of $0.8 million, reflecting an expansion of the worldwide sales and marketing organization, and costs to exit a distributor relationship of $0.3 million.

Adjusted EBITDA was $0.4 million and net loss was $1.0 million for the third quarter of 2010. Cash, cash equivalents and investments were $11.5 million at September 30, 2010 and cash provided by operations during the quarter was $0.3 million.

Conference Call

AtriCure will host a conference call at 10:00 a.m. Eastern Time on Tuesday, November 2, 2010 to discuss its third quarter 2010 financial results. A live web cast of the conference call will be available online from the investor relations page of AtriCure’s corporate web site at www.atricure.com.

Pre-registration is available and recommended for this call at the following URL:

https://cossprereg.btci.com/prereg/key.process?key=PDADX9N4K

You may also access this call through an operator by calling (888) 713-4211 for domestic callers and (617) 213-4864 for international callers at least 15 minutes prior to the call start time using reservation code 28142510.

The webcast will be available on AtriCure’s web site and a telephonic replay of the call will also be available through December 2, 2010. The replay dial-in numbers are (888) 286-8010 for domestic callers and (617) 801-6888 for international callers. The reservation code is 86093298.


 

About AtriCure, Inc.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue and systems for the exclusion of the left atrial appendage. The Company believes cardiothoracic surgeons are adopting its products for the treatment of atrial fibrillation, or AF, during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. AtriCure is conducting clinical trials in support of an AF indication. However, to date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF or a reduction in the risk of stroke.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as earnings estimates, other predictions of financial performance, launches by AtriCure of new products and market acceptance of AtriCure’s products. 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. These risks and uncertainties include the rate and degree of market acceptance of AtriCure’s products, AtriCure’s ability to develop and market new and enhanced products, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCure’s products, competition from existing and new products and procedures or AtriCure’s ability to effectively react to other risks and uncertainties described from time to time in AtriCure’s SEC filings, such as fluctuation of quarterly financial results, reliance on third party manufacturers and suppliers, litigation (including the purported class action lawsuits) or other proceedings, government regulation and stock price volatility. AtriCure does not guarantee any forward-looking statement, and actual results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Use of Non-GAAP Financial Measures

To supplement AtriCure’s condensed consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles, or GAAP, AtriCure uses certain non-GAAP financial measures in this release as supplemental financial metrics. Non-GAAP financial measures provide an indication of performance excluding certain items. Our management believes that in order to properly understand short-term and long-term financial trends, investors may wish to consider the impact of these excluded items in addition to GAAP measures. The excluded items vary in frequency and/or impact on our continuing operations and our management believes that the excluded items are typically not reflective of our ongoing core business operations. Further, management uses results of operations before these excluded items as a basis for its strategic planning. The non-GAAP financial measures used by AtriCure may not be the same or calculated the same as those used by other companies. Reconciliations of the non-


GAAP financial measures used in this release to the most comparable GAAP measures for the respective periods can be found in tables later in this release. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for AtriCure’s financial results prepared and reported in accordance with GAAP.


 

ATRICURE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2010     2009     2010     2009  

Revenue

   $ 14,473,113      $ 13,281,336      $ 42,617,225      $ 40,733,189   

Cost of revenue

     3,299,152        3,278,090        9,535,461        9,330,564   
                                

Gross profit

     11,173,961        10,003,246        33,081,764        31,402,625   

Operating expenses:

        

Research and development expenses

     2,937,043        2,580,766        8,017,414        8,635,938   

Selling, general and administrative expenses

     9,067,807        8,087,896        28,018,385        25,585,272   

Goodwill impairment

     —          —          —          6,812,389   

Settlement reserve

     —          3,766,623        —          3,766,623   
                                

Total operating expenses

     12,004,850        14,435,285        36,035,799        44,800,222   
                                

Loss from operations

     (830,889     (4,432,039     (2,954,035     (13,397,597

Other expense

     (196,977     (268,372     (849,369     (753,077
                                

Loss before income tax (provision) benefit

     (1,027,866     (4,700,411     (3,803,404     (14,150,674

Income tax (provision) benefit

     (1,444     3,441        237        45,714   
                                

Net loss

   $ (1,029,310   $ (4,696,970   $ (3,803,167   $ (14,104,960
                                

Basic and diluted net loss per share

   $ (0.07   $ (0.32   $ (0.25   $ (0.98
                                

Weighted average shares outstanding:

        

basic and diluted

     15,148,815        14,614,217        15,057,672        14,456,954   
                                


 

ATRICURE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

     September 30,
2010
    December 31,
2009
 

Assets

    

Current assets:

    

Cash, cash equivalents and short-term investments

   $ 11,456,275      $ 15,722,098   

Accounts receivable

     8,767,264        7,248,087   

Inventories

     6,631,463        4,869,708   

Other current assets

     5,431,989        3,511,335   
                

Total current assets

     32,286,991        31,351,228   

Property and equipment, net

     2,969,540        3,008,699   

Intangible assets

     106,250        287,653   

Other assets

     310,669        334,756   
                

Total assets

   $ 35,673,450      $ 34,982,336   
                

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable and accrued liabilities

   $ 13,502,258      $ 9,579,119   

Current maturities of debt and capital lease obligations

     2,202,105        2,227,431   
                

Total current liabilities

     15,704,363        11,806,550   

Long-term debt and capital lease obligations

     1,171,639        2,669,666   

Other liabilities

     3,084,829        3,416,360   
                

Total liabilities

     19,960,831        17,892,576   

Stockholders’ equity:

    

Common stock

     15,588        15,353   

Additional paid-in capital

     113,335,927        110,900,087   

Other comprehensive income

     134,241        144,290   

Accumulated deficit

     (97,773,137     (93,969,970
                

Total stockholders’ equity

     15,712,619        17,089,760   
                

Total liabilities and stockholders’ equity

   $ 35,673,450      $ 34,982,336   
                


 

ATRICURE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

     Nine Months Ended September 30,  
     2010     2009  

Cash flows from operating activities:

    

Net loss

   $ (3,803,167   $ (14,104,960

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

    

Depreciation and amortization

     1,775,699        1,787,727   

Amortization of deferred financing costs and discount on long-term debt

     225,386        275,537   

Share-based compensation

     2,144,105        2,737,842   

Gain on disposal of equipment

     (1,563     —     

Change in allowance for doubtful accounts

     (20,509     8,908   

Goodwill impairment

     —          6,812,389   

Settlement reserve

     —          3,766,623   

Changes in assets and liabilities:

    

Accounts receivable

     (1,559,264     84,201   

Inventories

     (1,786,129     914,171   

Other current assets

     762,289        (177,754

Accounts payable and accrued liabilities

     701,047        (1,668,753

Other non-current assets and liabilities

     (4,991     (105,938
                

Net cash (used in) provided by operating activities

     (1,567,097     329,993   

Cash flows from investing activities:

    

Purchases of equipment

     (1,534,687     (1,006,163

Purchases of available-for-sale securities

     (7,263,213     (5,824,661

Maturities of available-for-sale securities

     6,148,491        —     

Change in restricted cash and cash equivalents

     —          6,000,000   
                

Net cash used in investing activities

     (2,649,409     (830,824

Cash flows from financing activities:

    

Payments on debt and capital leases

     (1,670,091     (6,928,044

Proceeds from borrowings of debt

     —          6,500,000   

Payment of debt fees

     (85,059     (207,013

Proceeds from stock option exercises

     204,354        9,585   

Proceeds from issuance of common stock under employee stock purchase plan

     225,084        120,410   
                

Net cash used in financing activities

     (1,325,712     (505,062

Effect of exchange rate changes on cash and cash equivalents

     162,884        131,036   
                

Net decrease in cash and cash equivalents

     (5,379,334     (874,857

Cash and cash equivalents—beginning of period

     8,905,425        11,448,451   
                

Cash and cash equivalents—end of period

   $ 3,526,091      $ 10,573,594   
                


 

ATRICURE, INC.

RECONCILIATION OF GAAP RESULTS TO NON-GAAP RESULTS

(Unaudited)

Reconciliation of Net Loss and Net Loss per Share to Non-GAAP Net Loss and Net Loss per Share

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2010     2009     2010     2009  

Net loss, as reported

   $ (1,029,310   $ (4,696,970   $ (3,803,167   $ (14,104,960

Goodwill impairment, net of tax

     —          —          —          6,812,389   

Settlement reserve

     —          3,766,623        —          3,766,623   
                                

Non-GAAP adjusted net loss

   $ (1,029,310   $ (930,347   $ (3,803,167   $ (3,525,948
                                

Basic and diluted net loss per share, as reported

   $ (0.07   $ (0.32   $ (0.25   $ (0.98

Goodwill impairment, net of tax

     —          —          —          0.47   

Settlement reserve

     —          0.26        —          0.26   
                                

Non-GAAP adjusted basic and diluted net loss per share

   $ (0.07   $ (0.06   $ (0.25   $ (0.24
                                

Weighted averages shares outstanding, basic and diluted

     15,148,815        14,614,217        15,057,672        14,456,954   

Reconciliation of Operating Expenses and Loss from Operations to Non-GAAP Operating Expenses and Loss from Operations

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2010     2009     2010     2009  

Operating expenses, as reported

   $ 12,004,850      $ 14,435,285      $ 36,035,799      $ 44,800,222   

Goodwill impairment

     —          —          —          6,812,389   

Settlement reserve

     —          3,766,623        —          3,766,623   
                                

Non-GAAP adjusted operating expenses

   $ 12,004,850      $ 10,668,662      $ 36,035,799      $ 34,221,210   
                                

Loss from operations, as reported

   $ (830,889   $ (4,432,039   $ (2,954,035   $ (13,397,597

Goodwill impairment

     —          —          —          6,812,389   

Settlement reserve

     —          3,766,623        —          3,766,623   
                                

Non-GAAP adjusted loss from operations

   $ (830,889   $ (665,416   $ (2,954,035   $ (2,818,585
                                

Reconciliation of Non-GAAP Adjusted Earnings (Adjusted EBITDA)

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2010     2009     2010     2009  

Net loss, as reported

   $ (1,029,310   $ (4,696,970   $ (3,803,167   $ (14,104,960

Income tax expense (benefit)

     1,444        (3,441     (237     (45,714

Other expense (a)

     196,977        268,372        849,369        753,077   

Depreciation and amortization expense

     539,046        602,459        1,775,699        1,787,727   

Share-based compensation expense

     705,124        766,829        2,144,105        2,737,842   

Goodwill impairment

     —          —          —          6,812,389   

Settlement reserve

     —          3,766,623        —          3,766,623   
                                

Non-GAAP adjusted earnings (adjusted EBITDA)

   $ 413,281      $ 703,872      $ 965,769      $ 1,706,984   
                                
     Three Months Ended September 30,     Nine Months Ended September 30,  
     2010     2009     2010     2009  

(a) Other includes:

        

Interest expense

   $ (194,756   $ (233,243   $ (659,702   $ (434,063

Grant income

     52,530        —          52,530        —     

(Loss) gain due to exchange rate fluctuation

     (10,627     4,482        (170,579     (125,775

Non-employee stock option expense

     (44,124     (39,611     (71,618     (90,754

Write-off of deferred financing costs

     —          —          —          (102,485
                                

Other expense

   $ (196,977   $ (268,372   $ (849,369   $ (753,077
                                

# # #

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M_=JU"&F+,LP$Q0.L*:A4"G[*0B)S<-GP+1>/*;'4\'TCA5?9]6/_V3\_ ` end
-----END PRIVACY-ENHANCED MESSAGE-----