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): February 18, 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 February 18, 2010, the Company issued a press release and is holding a conference call regarding its financial results for the fourth quarter and full year ended December 31, 2009. 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 February 18, 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 hereunto duly authorized.

 

ATRICURE, INC.
By:  

/s/ Julie A. Piton

  Julie A. Piton
  Vice President, Finance and Administration and Chief Financial Officer

Dated: February 18, 2010

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 Fourth Quarter and Full Year 2009 Financial Results

Highlights

 

   

Fourth quarter revenues up 14.4 percent to $13.8 million

 

   

2009 record adjusted EBITDA of $1.6 million – improvement of $7.2 million

 

   

2009 cash provided by operations of $0.4 million – improvement of $6.1 million

 

   

2009 record international sales of $10.4 million – up 24.9 percent

 

   

Definitive settlement agreement executed with the DOJ

WEST CHESTER, Ohio – February 18, 2010 – AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems, today announced revenues of $13.8 million for its fourth quarter of 2009. For 2009, the company reported positive adjusted EBITDA, a non-GAAP measure, of $1.6 million, an improvement of $7.2 million.

“Although 2009 was a challenging year, the men and women of AtriCure demonstrated their high level of commitment, skillfulness and resolve. We successfully executed our strategic priorities of accelerating profitability, advancing FDA atrial fibrillation approvals and expanding our market leading position through the development of new, innovative growth platforms,” said David J. Drachman, President and Chief Executive Officer. “As we look forward to 2010, we are focused on capitalizing on our growth platforms which include launching our AtriClip system in the United States and initiating our FDA regulated Dual Epicardial Endocardial Persistent AF (DEEP AF) clinical trial. We are confident that AtriCure is well positioned to deliver results for patients, physicians and shareholders.”

2009 Financial Results

Revenues for 2009 were $54.5 million, a $0.7 million decrease as compared to 2008 revenues of $55.3 million. Revenues from domestic open heart products for 2009 increased to $27.5 million from $27.1 million. Revenues from domestic minimally invasive products declined from $19.8 million for 2008 to $16.6 million for 2009. 2008 revenues from minimally invasive products benefited from the inclusion of sales associated with the OR Lab™ system. International revenues for 2009 grew $2.1 million to a record $10.4 million, representing growth of 24.9 percent on a GAAP basis or 28.2 percent on a currency neutral basis. The increase in international revenues was driven primarily by market share gains.


Gross profit of $41.8 million for 2009 was relatively consistent with 2008 and gross margin was 76.6 percent, compared to gross margin of 76.1 percent for 2008. The expansion of gross margin was primarily due to a reduction in capital equipment revenues; partially offset by an increased mix of revenues from international sales and the introduction of new products, which initially carry a higher product cost.

Operating expenses on a GAAP basis for 2009 were $57.3 million as compared to $53.0 million for 2008. Non-GAAP operating expenses, neutralizing the impact of the $4.0 million Department of Justice settlement and $6.8 million goodwill impairment, were $46.5 million, a $6.5 million or 12.3 percent reduction when compared to 2008 operating expenses. The reduction in non-GAAP operating expenses was driven primarily by a reduction in headcount-related expenses. Loss from operations was $15.5 million. Non-GAAP loss from operations was a record $4.7 million, an improvement of $6.3 million, or 56.9 percent, as compared with 2008. The net loss per share was $1.13. Non-GAAP net loss per share was a record $0.39 as compared to $0.72 for 2008.

Adjusted EBITDA was a record $1.6 million, an improvement of $7.2 million as compared to an adjusted EBITDA loss of $5.6 million for 2008. The improvement in adjusted EBITDA was driven by a reduction in operating expenses.

Cash, cash equivalents and investments were $15.7 million at December 31, 2009 and cash generated from operations during the year was a record $0.4 million.

Fourth Quarter 2009 Financial Results

Revenues for the fourth quarter of 2009 increased 14.4 percent to $13.8 million. Domestic open heart revenues grew 11.6 percent to $6.7 million and domestic revenues from minimally invasive products grew $0.1 million to $4.1 million. Revenues from international sales grew to a record $3.0 million, or 45.8 percent on a GAAP basis and 38.1 percent on a currency neutral basis.

Gross profit for the fourth quarter of 2009 was $10.4 million and gross margin was 75.2 percent as compared to gross profit of $9.0 million and gross margin of 74.3 percent for the fourth quarter of 2008. Gross margin expansion was driven by a reduction in the sale of capital equipment, partially offset by an increased mix of international revenues.

Operating expenses for the fourth quarter of 2009 were $12.5 million as compared to $12.4 million for the fourth quarter of 2008. Included in fourth quarter 2009 operating expenses was a non-recurring charge related to share-based compensation of $0.5 million. Loss from operations improved $1.3 million from $3.5 million for the fourth quarter of 2008 to $2.1 million for the fourth quarter of 2009.

Adjusted EBITDA was a loss of $0.2 million for the fourth quarter of 2009, an improvement of $1.8 million as compared to an adjusted EBITDA loss of $2.0 million for the fourth quarter of 2008. The improvement in adjusted EBITDA was driven by a reduction in operating expenses.


Earnings Call Information

Management will host a conference call at 10:00 a.m. Eastern Time on Thursday, February 18, 2010 to discuss its fourth quarter and full year 2009 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://www.theconferencingservice.com/prereg/key.process?key=PFRRMKUCP

You may also access this call through an operator by calling 888-713-4199 for domestic callers and 617-213-4861 for international callers at least 15 minutes prior to the call start time using reservation code 71939893.

The webcast will be available on AtriCure’s web site and a telephonic replay of the call will also be available through March 18, 2010. The replay dial-in numbers are 888-286-8010 for domestic callers and 617-801-6888 for international callers. The reservation code is 52921254.

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. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator® bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator system as a promising treatment alternative for patients who may be candidates for 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. The FDA has cleared the AtriCure Isolator system and AtriCure’s multifunctional pen and CoolrailTM linear ablation device, for the ablation, or destruction, of cardiac tissue during surgical procedures. Additionally, the FDA has cleared AtriCure’s multifunctional pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias and AtriCure’s Cryo1TM system for the cryosurgical treatment of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF.


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
December 31,
    Twelve Months Ended
December 31,
 
     2009     2008     2009     2008  

Revenues

   $ 13,800,370      $ 12,066,363      $ 54,533,558      $ 55,257,023   

Cost of revenues

     3,420,181        3,102,678        12,750,745        13,224,504   
                                

Gross profit

     10,380,189        8,963,685        41,782,813        42,032,519   

Operating expenses:

        

Research and development expenses

     2,778,951        2,573,202        11,414,889        10,608,668   

Selling, general and administrative expenses

     9,526,734        9,848,900        35,112,006        42,422,133   

Goodwill impairment

     —          —          6,812,389        —     

Settlement reserve

     188,782        —          3,955,405        —     
                                

Total operating expenses

     12,494,467        12,422,102        57,294,689        53,030,801   
                                

Loss from operations

     (2,114,278     (3,458,417     (15,511,876     (10,998,282

Other (expense) income

     (288,674     201,938        (1,041,751     773,778   
                                

Loss before income tax benefit

     (2,402,952     (3,256,479     (16,553,627     (10,224,504

Income tax benefit

     12,925        57,252        58,639        57,252   
                                

Net loss

   $ (2,390,027   $ (3,199,227   $ (16,494,988   $ (10,167,252
                                

Basic and diluted net loss per share

   $ (0.16   $ (0.22   $ (1.13   $ (0.72
                                

Weighted average shares outstanding:

        

basic and diluted

     14,880,498        14,220,321        14,563,710        14,191,000   
                                


ATRICURE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

     December 31,
2009
    December 31,
2008
 

Assets

    

Current assets:

    

Cash, cash equivalents and short-term investments

   $ 15,722,098      $ 11,448,451   

Accounts receivable

     7,248,087        6,511,594   

Inventories

     4,869,708        6,361,242   

Other current assets

     3,511,335        1,781,825   
                

Total current assets

     31,351,228        26,103,112   

Property and equipment, net

     3,008,699        3,682,819   

Intangible assets

     287,653        569,153   

Goodwill

     —          6,812,389   

Restricted cash and cash equivalents

     —          6,000,000   

Other assets

     334,756        201,359   
                

Total assets

   $ 34,982,336      $ 43,368,832   
                

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable and accrued liabilities

   $ 9,579,119      $ 8,072,596   

Current maturities of debt and capital lease obligations

     2,227,431        34,004   
                

Total current liabilities

     11,806,550        8,106,600   

Long-term debt and capital lease obligations

     2,669,666        6,036,605   

Other liabilities

     3,416,360        106,470   
                

Total liabilities

     17,892,576        14,249,675   

Stockholders’ equity:

    

Common stock

     15,353        14,275   

Additional paid-in capital

     110,900,087        106,636,653   

Other comprehensive income (loss)

     144,290        (56,789

Accumulated deficit

     (93,969,970     (77,474,982
                

Total stockholders’ equity

     17,089,760        29,119,157   
                

Total liabilities and stockholders’ equity

   $ 34,982,336      $ 43,368,832   
                


ATRICURE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

     Twelve Months Ended
December 31,
 
     2009     2008  
                

Cash flows from operating activities:

    

Net loss

   $ (16,494,988   $ (10,167,252

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

    

Depreciation and amortization

     2,413,800        2,682,204   

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

     359,064        113,678   

Loss on disposal of equipment

     5,517        151,518   

(Benefit from) provision for losses in accounts receivable

     (9,581     20,440   

Goodwill impairment

     6,812,389        —     

Settlement reserve

     3,955,405        —     

Share-based compensation

     3,885,596        2,671,003   

Changes in assets and liabilities, excluding effects of acquired business:

    

Accounts receivable

     (685,986     609,337   

Inventories

     1,504,706        (1,149,231

Other current assets

     169,163        (342,710

Accounts payable and accrued liabilities

     (1,409,466     (148,413

Other non-current assets and liabilities

     (85,671     (150,514
                

Net cash provided by (used in) operating activities

     419,948        (5,709,940

Cash flows from investing activities:

    

Purchases of property & equipment

     (1,360,459     (1,747,590

Purchases of available-for-sale securities

     (8,015,866     (1,900,756

Maturities of available-for-sale securities

     1,201,877        8,894,670   

Change in restricted cash and cash equivalents

     6,000,000        (6,000,000

Cash paid for acquisition

     —          (417,292

Net proceeds from sale of property and equipment

     2,000        —     
                

Net cash used in investing activities

     (2,172,448     (1,170,968

Cash flows from financing activities:

    

Payments on debt and capital leases

     (7,493,269     (721,917

Proceeds from borrowings of debt

     6,500,000        6,000,000   

Payment of debt fees

     (235,110     (340,932

Proceeds from stock option exercises

     33,335        239,873   

Proceeds from issuance of common stock under employee stock purchase plan

     281,035        103,640   
                

Net cash (used in) provided by financing activities

     (914,009     5,280,664   

Effect of exchange rate changes on cash and cash equivalents

     123,483        48,043   
                

Net decrease in cash and cash equivalents

     (2,543,026     (1,552,201

Cash and cash equivalents - beginning of period

     11,448,451        13,000,652   
                

Cash and cash equivalents - end of period

   $ 8,905,425      $ 11,448,451   
                


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
December 31,
    Twelve Months Ended
December 31,
 
     2009     2008     2009     2008  

Net loss, as reported

   $ (2,390,027   $ (3,199,227   $ (16,494,988   $ (10,167,252

Goodwill impairment, net of tax

     —          —          6,812,389        —     

Settlement reserve

     188,782        —          3,955,405        —     
                                

Non-GAAP adjusted net loss

   $ (2,201,245   $ (3,199,227   $ (5,727,194   $ (10,167,252
                                

Basic and diluted net loss per share, as reported

   $ (0.16   $ (0.22   $ (1.13   $ (0.72

Goodwill impairment, net of tax

     —          —          0.47        —     

Settlement reserve

     0.01        —          0.27        —     
                                

Non-GAAP adjusted basic and diluted net loss per share

   $ (0.15   $ (0.22   $ (0.39   $ (0.72
                                

Weighted averages shares outstanding, basic and diluted

     14,880,498        14,220,321        14,563,710        14,191,000   

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

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2009     2008     2009     2008  

Operating expenses, as reported

   $ 12,494,467      $ 12,422,102      $ 57,294,689      $ 53,030,801   

Goodwill impairment

     —          —          6,812,389        —     

Settlement reserve, net of tax

     188,782        —          3,955,405        —     
                                

Non-GAAP adjusted operating expenses

   $ 12,305,685      $ 12,422,102      $ 46,526,895      $ 53,030,801   
                                

Loss from operations, as reported

   $ (2,114,278   $ (3,458,417   $ (15,511,876   $ (10,998,282

Goodwill impairment

     —          —          6,812,389        —     

Settlement reserve, net of tax

     188,782        —          3,955,405        —     
                                

Non-GAAP adjusted loss from operations

   $ (1,925,496   $ (3,458,417   $ (4,744,082   $ (10,998,282
                                

Reconciliation of Non-GAAP Adjusted Earnings (Loss) (Adjusted EBITDA)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2009     2008     2009     2008  

Net loss, as reported

   $ (2,390,027   $ (3,199,227   $ (16,494,988   $ (10,167,252

Income tax provision (benefit)

     (12,925     (57,252     (58,639     (57,252

Other expense (income) (a)

     288,674        (201,938     1,041,751        (773,778

Depreciation and amortization expense

     626,073        609,011        2,413,800        2,682,204   

Share-based compensation expense

     1,147,754        889,720        3,885,596        2,671,003   

Goodwill impairment

     —          —          6,812,389        —     

Settlement reserve

     188,782        —          3,955,405        —     
                                

Non-GAAP adjusted (loss) earnings (Adjusted EBITDA)

   $ (151,669   $ (1,959,686   $ 1,555,314      $ (5,645,075
                                
     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2009     2008     2009     2008  

(a) Other includes:

        

Interest (expense) income

   $ (224,689   $ (39,128   $ (658,752   $ 18,213   

Write-off of deferred financing costs

     —          —          (102,485     —     

Grant income

     —          74,187        —          296,748   

Loss due to exchange rate fluctuation

     (14,819     (141,060     (140,594     (64,176

Non-employee stock option (expense) income

     (49,166     307,939        (139,920     522,993   
                                

Other (expense) income

   $ (288,674   $ 201,938      $ (1,041,751   $ 773,778   
                                

# # #