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Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2004

 

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: 0-32259

 


 

Align Technology, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   94-3267295

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

881 Martin Avenue

 

Santa Clara, California 95050

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

 

(408) 470-1000

(Registrant’s telephone number, including area code)

 

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 x No ¨

 

Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes x No ¨

 

The number of shares outstanding of the registrant’s Common Stock, $0.001 par value, as of April 30, 2004 was 59,613,665.

 



Table of Contents

Table Of Contents

 

ALIGN TECHNOLOGY, INC.

 

INDEX

 

PART I—FINANCIAL INFORMATION

   3

ITEM 1

 

FINANCIAL STATEMENTS (UNAUDITED):

   3
   

CONDENSED CONSOLIDATED BALANCE SHEETS

   3
   

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

   4
   

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

   5
   

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

   6

ITEM 2.

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

   10

ITEM 3.

 

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

   22

ITEM 4.

 

CONTROLS AND PROCEDURES

   22

PART II—OTHER INFORMATION

   23

ITEM 1.

 

LEGAL PROCEEDINGS

   23

ITEM 2.

 

CHANGES IN SECURITIES AND USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES

   23

ITEM 3.

 

DEFAULTS UPON SENIOR SECURITIES

   23

ITEM 4.

 

SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

   24

ITEM 5.

 

OTHER INFORMATION

   24

ITEM 6.

 

EXHIBITS AND REPORTS ON FORM 8-K

   24

SIGNATURES

   25

 

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Table of Contents

PART I—FINANCIAL INFORMATION

 

ITEM 1 FINANCIAL STATEMENTS

ALIGN TECHNOLOGY, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

     March 31,
2004


    December 31,
2003


 
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 47,816     $ 44,939  

Restricted cash

     352       439  

Marketable securities, short-term

     80       2,292  

Accounts receivable, net of allowance

     23,256       21,265  

Inventories

     1,272       1,395  

Deferred costs

     1,015       939  

Prepaid expenses and other current assets

     5,321       5,845  
    


 


Total current assets

     79,112       77,114  

Property and equipment, net

     22,586       23,121  

Other assets

     2,006       1,967  
    


 


Total assets

   $ 103,704     $ 102,202  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 2,307     $ 3,095  

Accrued liabilities

     16,216       19,180  

Deferred revenues

     13,067       13,113  

Current portion of equipment-based term loan

     1,667       1,667  

Current portion of capital lease obligations

     327       322  
    


 


Total current liabilities

     33,584       37,377  

Equipment-based term loan, net of current portion

     1,250       1,667  

Capital lease obligations, net of current portion

     98       182  
    


 


Total liabilities

     34,932       39,226  
    


 


Commitments and contingencies (Note 4)

                

Stockholders’ equity:

                

Preferred stock: $0.0001 par value; Authorized: 5,000 shares; Issued and outstanding: none at March 31, 2004 and December 31, 2003

     —         —    

Common stock: $0.0001 par value; Authorized: 200,000; Issued: 59,601 and 58,793 at March 31, 2004 and December 31, 2003, respectively; Outstanding: 59,561 and 58,753 shares at March 31, 2004 and December 31, 2003, respectively

     6       6  

Additional paid-in capital

     371,923       368,796  

Deferred compensation

     (3,122 )     (5,219 )

Notes receivable from stockholders

     —         (17 )

Accumulated other comprehensive income

     —         2  

Accumulated deficit

     (300,035 )     (300,592 )
    


 


Total stockholders’ equity

     68,772       62,976  
    


 


Total liabilities and stockholders’ equity

   $ 103,074     $ 102,202  
    


 


 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

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Table of Contents

ALIGN TECHNOLOGY, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
March 31,


 
     2004

    2003

 

Revenues

   $ 39,205     $ 22,960  

Cost of revenues

     13,393       11,924  
    


 


Gross profit

     25,812       11,036  
    


 


Operating expenses:

                

Sales and marketing

     13,272       10,630  

General and administrative

     8,277       7,894  

Research and development

     3,346       2,985  
    


 


Total operating expenses

     24,895       21,509  
    


 


Profit (loss) from operations

     917       (10,473 )

Interest and other income (expense), net

     (227 )     (197 )
    


 


Net profit (loss) before provision for income taxes

     690       (10,670 )

Provision for income taxes

     (133 )     (1 )
    


 


Net profit (loss)

   $ 557     $ (10,671 )
    


 


Net profit (loss) per share, basic

   $ 0.01     $ (0.19 )
    


 


Shares used in computing net profit (loss) per share, basic

     59,091       57,189  
    


 


Net profit (loss) per share, diluted

   $ 0.01     $ (0.19 )
    


 


Shares used in computing net profit (loss) per share, diluted

     64,559       57,189  
    


 


 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

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Table of Contents

ALIGN TECHNOLOGY, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Three Months Ended
March 31,


 
     2004

    2003

 

Cash Flows from Operating Activities:

                

Net profit (loss)

   $ 557     $ (10,671 )

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

                

Depreciation and amortization

     2,184       2,297  

Stock-based compensation expense

     2,217       4,263  

Loss on retirement and disposal of fixed assets

     6       145  

Provision for doubtful accounts

     86       (4 )

Non-cash interest income on notes receivable from stockholders

     —         (20 )

Non-cash accretion on marketable securities

     (2 )     12  

Changes in operating assets and liabilities:

                

Accounts receivable

     (2,077 )     (308 )

Inventories

     123       (229 )

Deferred costs

     (76 )     108  

Other current assets

     524       (1,745 )

Accounts payable

     (788 )     (434 )

Accrued liabilities

     (2,964 )     1,201  

Deferred revenue

     (46 )     2,138  
    


 


Net cash used in operating activities

     (256 )     (3,247 )
    


 


Cash Flows from Investing Activities:

                

Purchase of property and equipment

     (1,655 )     (630 )

Decrease (increase) in restricted cash

     87       (4 )

Maturities of marketable securities

     2,212       2,669  

Other assets

     (39 )     (147 )
    


 


Net cash provided by investing activities

     605       1,888  
    


 


Cash Flows from Financing Activities:

                

Proceeds from issuance of common stock

     3,007       225  

Proceeds from payment on stockholders’ notes receivable

     17       120  

Payments on debt obligations

     (496 )     (541 )
    


 


Net cash provided by (used in) financing activities

     2,528       (196 )
    


 


Net increase (decrease) in cash and cash equivalents

     2,877       (1,555 )

Cash and cash equivalents at beginning of period

     44,939       35,552  
    


 


Cash and cash equivalents at end of period

   $ 47,816     $ 33,997  
    


 


 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

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Table of Contents

ALIGN TECHNOLOGY, INC.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

 

1. Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared by Align Technology, Inc. (the “Company” or “Align”) in accordance with the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted in accordance with such rules and regulations. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, necessary to present fairly the financial position of the Company as of March 31, 2004 and December 31, 2003, and its results of operations and cash flows for the three months ended March 31, 2004 and 2003. These unaudited condensed consolidated financial statements should be read in conjunction with the annual audited consolidated financial statements and notes as of and for the year ended December 31, 2003 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 9, 2004.

 

The results of operations for the three months ended March 31, 2004 are not necessarily indicative of the results that may be expected for the year ending December 31, 2004 or any other interim period, and the Company makes no representations related thereto.

 

The condensed consolidated financial statements include the accounts of the Company and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

 

Certain risks and uncertainties

 

The Company’s operating results depend on, to a significant extent, the Company’s ability to market and develop its products. The life cycles of the Company’s products are difficult to estimate due in part to the effect of future product enhancements and competition. The Company’s inability to successfully develop and market its products as a result of competition or other factors would have a material adverse effect on the Company’s business, financial condition and results of operations.

 

Financial instruments which potentially expose the Company to concentrations of credit risk consist primarily of cash equivalents and accounts receivable. The Company invests excess cash primarily in commercial paper. The Company provides credit to customers in the normal course of business. Collateral is not required for accounts receivable, but ongoing evaluations of customers’ credit worthiness are performed. The Company maintains reserves for potential credit losses and such losses have been within management’s expectations. No individual customer accounted for 10% or more of the Company’s accounts receivable at March 31, 2004 or at December 31, 2003, or net revenues for the three months ended March 31, 2004 or 2003.

 

The Food and Drug Administration (“FDA”) regulates the design, manufacture, distribution, preclinical and clinical study, clearance and approval of medical devices. Products developed by the Company may require approvals or clearances from the FDA or other international regulatory agencies prior to commercialized sales. There can be no assurance that the Company’s products will receive any of the required approvals or clearances. If the Company were to be denied approval or clearance or such approval were to be delayed, it may have a material adverse impact on the Company.

 

The Company has manufacturing operations located outside the United States of America. The Company currently relies on its manufacturing facilities in Costa Rica to create virtual treatment plans with the assistance of sophisticated software. In addition, the Company relies on a third party manufacturer in Mexico to fabricate Aligners and to ship the completed product to the Company’s customers. The Company’s reliance on international operations exposes it to related risks and uncertainties, including: difficulties in staffing and managing international operations, controlling quality of the manufacturing process, political, social and economic instability, interruptions and limitations in telecommunication services, product and/or material transportation delays or disruption, trade restrictions and changes in tariffs, import and export license requirements and restrictions, fluctuations in currency exchange rates and potential adverse tax consequences. If any of these risks materialize, the Company’s international manufacturing operations, as well as its operating results, may be harmed.

 

The Company receives certain of its components from sole suppliers. Additionally, the Company relies on a limited number of hardware manufacturers. The inability of any supplier or manufacturer to fulfill supply requirements of the Company could materially impact future operating results.

 

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Table of Contents
2. Net Profit (Loss) Per Share

 

Basic net profit (loss) per share is computed using the weighted average number of shares of common stock during the year. Diluted net profit (loss) per share is computed using the weighted average number of shares of common stock, adjusted for the dilutive effect of potential common stock. Potential common stock, computed using the treasury stock method or the if-converted method, includes options and unvested shares subject to repurchase.

 

The following table sets forth the computation of basic and diluted net profit (loss) per share attributable to common shareholders (in thousands, except per share amounts):

 

     Three Months Ended
March 31,


 
     2004

    2003

 

Numerator:

                

Net profit (loss)

   $ 557     $ (10,671 )
    


 


Denominator:

                

Weighted-average common shares outstanding

     59,253       57,766  

Less: Unvested common shares subject to repurchase

     (162 )     (577 )
    


 


Total shares, basic

     59,091       57,189  
    


 


Effect of dilutive securities:

                

Add: Dilutive common stock equivalents

     5,306       —    

Unvested shares subject to repurchase

     162       —