Align
Invisalign Itero

Press Release

Oct 24, 2007

Align Technology Announces Third Quarter 2007 Results

SANTA CLARA, Calif., Oct 24, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the third quarter, ended September 30, 2007. Total revenues for the third quarter of 2007 (Q3 07) were $71.5 million. This reflects a year-over-year increase of 46 percent compared to $49.0 million in the third quarter of 2006 (Q3 06). On a sequential basis revenues decreased 7 percent in a seasonally slower quarter, compared to $76.6 million in the second quarter of 2007 (Q2 07). As disclosed previously, Q2 07 revenues of $76.6 million included $5.2 million in backlog shipments caused by the allocation of capacity to the Patients First Program during prior quarters.

"I'm pleased with the financial results for the third quarter with revenue growth of 46 percent year over year and EPS four cents higher than expectations. Continued improvement from operations and stable ASPs resulted in stronger than expected gross margin of 74.6 percent," said Thomas M. Prescott, president and CEO of Align Technology. "We continue to see strong consumer interest for the Invisalign system and demand for doctor certification remains high."

On a generally accepted accounting principles (GAAP) basis, net profit for Q3 07 was $9.5 million, or $0.13 per diluted share. This reflects a significant increase from a GAAP net loss of $10.3 million, or $0.16 loss per diluted share in Q3 06, and a decrease in GAAP net profit from $13.6 million, or $0.19 per diluted share in Q2 07.

Non-GAAP net profit for Q3 07 was $12.6 million or $0.17 per diluted share. This reflects a significant increase from a non-GAAP net loss of $8.0 million, or $0.13 loss per diluted share in Q3 06, and a decrease in non-GAAP net profit from $16.5 million, or $0.23 per diluted share in Q2 07. Non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A detailed reconciliation between GAAP and non-GAAP information is contained in the tables included below.



    Q3 07 Operating Results

    Key GAAP Operating Results        Q3 07           Q2 07         Q3 06
    Gross Margin                      74.6%           73.6%         65.8%
    Operating Expense                $44.9M          $42.9M        $43.2M
    Net Profit (Loss)                 $9.5M          $13.6M       ($10.3M)
    Earnings (Loss) Per
     Diluted Share (EPS)              $0.13           $0.19        ($0.16)

    Key Non-GAAP Operating Results    Q3 07           Q2 07         Q3 06
    Non-GAAP Gross Margin             75.0%           73.8%         66.1%
    Non-GAAP Operating Expense       $41.8M          $40.3M        $41.1M
    Non-GAAP Net Profit (Loss)       $12.6M          $16.5M        ($8.0M)
    Non-GAAP Earnings (Loss)
     Per Diluted Share                $0.17           $0.23        ($0.13)



Liquidity and Capital Resources

As of September 30, 2007, Align had $110.0 million in cash, cash equivalents, marketable securities and restricted cash, compared to $64.1 million as of December 31, 2006.

Key Business Metrics

The following table highlights business metrics for Align's third quarter of 2007. Additional historical information is available on the Company's website at http://investor.aligntech.com.



    Revenue by Channel:               Q3 07       Q3'07/Q2'07    Q3'07/Q3'06
                                                   % Change       % Change
    U.S. Orthodontists        $22.5 million          (9.9%)         38.5%
    U.S. GP Dentists          $34.8 million          (4.3%)         53.4%
    International             $11.6 million          (0.0%)         58.6%
    Training and Other         $2.6 million         (28.2%)         (7.3%)
    Total Revenue             $71.5 million          (6.7%)         45.7%

    Average Selling Price (ASP):      Q3 07       Q3'07/Q2'07    Q3'07/Q3'06
                                                   % Change       % Change
    Total Worldwide Blended ASP      $1,320          (0.3%)          2.2%
    Total Worldwide ASP
     excluding Invisalign Express    $1,430          (0.4%)        (3.9%)
    U.S. Orthodontists Blended ASP   $1,230          (0.5%)        (2.0%)
    U.S. GP Dentists Blended ASP     $1,310          (0.0%)         6.0%
    International                    $1,580          (2.8%)        (3.2%)

    Number of Cases Shipped:          Q3 07       Q3'07/Q2'07    Q3'07/Q3'06
                                                   % Change       % Change
    U.S. Orthodontists -
     Full Invisalign                 15,150         (10.0%)        58.7%
    U.S. Orthodontists -
     Invisalign Express               3,100          (6.9%)        (8.1%)
    U.S. GP Dentists -
     Full Invisalign                 21,900          (3.9%)        74.8%
    U.S. GP Dentists -
     Invisalign Express               4,600          (6.5%)       (20.4%)
    International-
     Full Invisalign                  7,200           1.8%         66.1%
    International-
     Invisalign Express                 100          17.1%         (6.5%)
    Total Cases Shipped              52,050          (5.4%)        45.8%


    Number of Doctors Cases
     were Shipped to:                 Q3 07

    U.S. Orthodontists                3,710
    U.S. GP Dentists                 10,200
    International                     2,330
    Total Doctors Cases
     were Shipped to Worldwide       16,240

    Number of Doctors Trained
     Worldwide:                       Q3 07        Cumulative

    U.S. Orthodontists                   90           8,230
    U.S. GP Dentists                  1,220          25,980
    International                       260          11,840
    Total Doctors Trained
     Worldwide                        1,570          46,050

    Multiple Case Doctors
     (Cumulative as of):              Q3 07

    U.S. Orthodontists                89.1%
    U.S. GP Dentists                  87.3%
    International                     75.7%

    Doctors Starting Invisalign
     Treatment (Cumulative as of):    Q3 07

    U.S. Orthodontists                6,600
    U.S. GP Dentists                 20,480
    International                     6,240
    Total Doctors Starting
     Invisalign Treatment            33,320

    Doctor Utilization Rates*:        Q3 07           Q2 07         Q3 06

    U.S. Orthodontists                  4.9             5.3           4.7
    U.S. GP Dentists                    2.6             2.7           2.5
    International                       3.1             3.1           2.7
    Total Utilization Rate              3.2             3.4           3.0

    *Utilization = # of cases/# of doctors cases were shipped to



Business Outlook

For the fourth quarter 2007 (Q4 07), Align Technology expects revenues to increase 26 to 31 percent year over year and be in a range of $69.5 million and $72.2 million. GAAP earnings per diluted share for Q4 07 is expected to be in a range of $0.06 and $0.09. Non-GAAP earnings per diluted share for Q4 07 is expected to be in a range of $0.11 and $0.13.

For fiscal 2007, Align Technology expects revenues to increase 36 to 38 percent year over year and be in a range of $281.3 and $284.0 million. GAAP earnings per diluted share for fiscal 2007 is expected to be in a range of $0.49 and $0.51. Non-GAAP earnings per diluted share for fiscal 2007 is expected to be in a range of $0.63 and $0.65.

A more comprehensive business outlook, including a reconciliation of GAAP to Non-GAAP financial measures, is available following the financial tables of this release.

Align Webcast and Conference Call

Align Technology will host a conference call today, October 24, 2007 at 4:30 p.m. ET, 1:30 p.m. PT, to review its third quarter 2007 results, discuss future operating trends and business outlook. The conference call will also be webcast live via the Internet. To access the webcast, go to the "Events & Presentations" section under Company Information on Align Technology's Investor Relations web site at http://investor.aligntech.com. To access the conference call, please dial 201-689-8341 approximately fifteen minutes prior to the start of the call. If you are unable to listen to the call, an archived webcast will be available beginning approximately one hour after the call's conclusion and will remain available for approximately 12 months. Additionally, a telephonic replay of the call can be accessed by dialing 877-660-6853 with account number 292 followed by # and conference number 227480 followed by #. The replay must be accessed from international locations by dialing 201-612-7415 and using the same account and conference numbers referenced above. The telephonic replay will be available through 5:30 p.m. ET on November 7, 2007.

About Align Technology, Inc.

Align Technology designs, manufactures and markets Invisalign, a proprietary method for treating malocclusion, or the misalignment of teeth. Invisalign corrects malocclusion using a series of clear, nearly invisible, removable appliances that gently move teeth to a desired final position. Because it does not rely on the use of metal or ceramic brackets and wires, Invisalign significantly reduces the aesthetic and other limitations associated with braces. Invisalign is appropriate for treating adults and older teens. Align Technology was founded in March 1997 and received FDA clearance to market Invisalign in 1998.

To learn more about Invisalign or to find a certified Invisalign doctor in your area, please visit http://www.invisalign.com or call 1-800-INVISIBLE.

About non-GAAP Financial Measures

To supplement our consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principals (GAAP), we use the following non-GAAP financial measures: non-GAAP gross profit, gross margin, profit (loss) from operations, net profit (loss), earnings (loss) per share, and operating expenses, which exclude stock-based compensation. The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP. For more information on these non-GAAP financial measures, please see the tables captioned "Reconciliation of GAAP to Non-GAAP Condensed Consolidated Statements of Operations" and "Business Outlook Summary" included at the end of this release.

We use these non-GAAP financial measures for financial and operational decision making and as a means to evaluate period-to-period comparisons. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding our "core operating performance". Management believes that "core operating performance" represents Align's performance in the ordinary, ongoing and customary course of its operations. Accordingly, management excludes from "core operating performance" certain expenses and expenditures that may not be indicative of our operating performance including not only non-cash charges, such as stock-based compensation, but also discrete cash charges that are infrequent or one-time in nature. We believe that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting and analyzing future periods. These non-GAAP financial measures also facilitate management's internal evaluation of period-to-period comparisons. We believe these non-GAAP financial measures are useful to investors both because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making and (2) they are provided to and used by our institutional investors and the analyst community to help them analyze the health of our business.

Forward-Looking Statement

This news release, including the tables below, contain forward-looking statements, including statements regarding Align's anticipated financial results and certain business metrics for the fourth quarter and full year of 2007, including anticipated revenue, gross profit, gross margin, operating expense, net profit, earnings per share, percentage of revenue by channel, case shipments and average selling prices. Forward-looking statements contained in this news release and the tables below relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement. Factors that might cause such a difference include, but are not limited to, risks relating to Align's ability to sustain or increase profitability or revenue growth in future periods while controlling expenses, continued customer demand for Invisalign, the timing of case submissions from our doctors within a quarter, acceptance of Invisalign by consumers and dental professionals, Align's third party manufacturing processes and personnel, foreign operational, political and other risks relating to Align's international manufacturing operations, Align's ability to protect its intellectual property rights, competition from manufacturers of traditional braces and new competitors, Align's ability to develop and successfully introduce new products and product enhancements, and the loss of key personnel, including members of its direct sales force. These and other risks are detailed from time to time in Align's periodic reports filed with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K for the fiscal year ended December 31, 2006, which was filed with the Securities and Exchange Commission on March 12, 2007, and its Quarterly Reports on Form 10-Q. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.



    ALIGN TECHNOLOGY, INC.
    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (in thousands, except per share data)

                                    Three Months Ended    Nine Months Ended
                                   September  September  September  September
                                    30, 2007  30, 2006    30, 2007  30, 2006

    Revenues                         $71,451   $49,034  $211,815  $151,163

    Cost of revenues                  18,132    16,789    55,908    47,578

    Gross profit                      53,319    32,245   155,907   103,585

    Operating expenses:
      Sales and marketing             24,226    19,165    71,729    59,872
      General and administrative      13,949    19,238    38,014    49,656
      Research and development         6,749     4,807    19,117    13,526
      Patients First Program               -         -    (1,796)        -

    Total operating expenses          44,924    43,210   127,064   123,054


    Profit (loss) from operations      8,395   (10,965)   28,843   (19,469)

    Interest and other income, net     1,108       854     2,243     2,393

    Profit (loss) before
     income taxes                      9,503   (10,111)   31,086   (17,076)

    Provision for income taxes           (43)     (209)   (1,030)     (618)

    Net profit (loss)                 $9,460  $(10,320)  $30,056  $(17,694)

    Net profit (loss) per share
        - basic                        $0.14    $(0.16)    $0.45    $(0.28)
        - diluted                      $0.13    $(0.16)    $0.42    $(0.28)

    Shares used in computing
     net profit (loss) per share
        - basic                       67,970    63,230    66,709    62,907
        - diluted                     72,230    63,230    71,058    62,907



    ALIGN TECHNOLOGY, INC.
    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
    (in thousands)

                                        September 30, 2007   December 31, 2006
                         ASSETS
    Current assets:
      Cash and cash equivalents                 $87,969              $55,113
      Restricted cash                                20                   93
      Marketable securities, short-term          22,022                8,931
      Accounts receivable, net                   46,002               33,635
      Inventories, net                            3,542                3,090
      Other current assets                        7,592                7,227
          Total current assets                  167,147              108,089

      Property and equipment, net                26,014               26,904
      Goodwill and intangible assets, net        11,802               14,302
      Other long-term assets                      1,931                2,263

           Total assets                        $206,894             $151,558


             LIABILITIES AND STOCKHOLDERS' EQUITY

    Current liabilities:
      Line of credit                                $ -           $11,500
      Accounts payable                            6,344             5,034
      Accrued liabilities                        36,706            40,307
      Deferred revenue                           12,942            10,942
         Total current liabilities               55,992            67,783

    Other long term liabilities                     195               219

         Total liabilities                       56,187            68,002

    Total stockholders' equity                  150,707            83,556

        Total liabilities and
         stockholders' equity                  $206,894          $151,558



    ALIGN TECHNOLOGY, INC.
    RECONCILIATION OF GAAP TO NON-GAAP

    Reconciliation of GAAP to Non-GAAP Gross Profit
    (in thousands, except percentages)
                                                  Three Months Ended
                                        September 30,  June 30,  September 30,
                                            2007         2007        2006

    GAAP Gross profit                     $53,319      $56,356     $32,245
      Stock based compensation expense        259          210         186

    Non-GAAP Gross profit                 $53,578      $56,566     $32,431

    Non-GAAP Gross margin                   75.0%        73.8%       66.1%


    Reconciliation of GAAP to Non-GAAP Operating Expenses
    (in thousands)
                                                  Three Months Ended
                                        September 30,  June 30,  September 30,
                                            2007         2007        2006

    GAAP Operating expenses               $44,924      $42,908     $43,210
      Stock based compensation expense      3,129        2,655       2,091

    Non-GAAP Operating expenses           $41,795      $40,253     $41,119


    Reconciliation of GAAP to Non-GAAP Net Profit (Loss)
    (in thousands, except per share amounts)
                                                  Three Months Ended
                                        September 30,  June 30,  September 30,
                                            2007         2007        2006

    GAAP Net profit (loss)                  $9,460     $13,618     $(10,320)
      Stock based compensation expense       3,388       2,865        2,277
      Tax effect of stock based
       compensation expense                   (261)        (33)           -

    Non-GAAP Net profit (loss)             $12,587     $16,450      $(8,043)

    Diluted Net profit (loss) per share:
        GAAP                                 $0.13       $0.19       $(0.16)
        Non-GAAP                             $0.17       $0.23       $(0.13)

    Shares used in computing diluted net
     profit (loss) per share                72,230      71,207       63,230


    Summary of Stock Based Compensation Expense
    (in thousands)
                                                  Three Months Ended
                                        September 30,  June 30,  September 30,
                                            2007         2007        2006

    Cost of revenues                        $259         $210         $186
    Sales and marketing                    1,301          898          714
    General and administrative             1,403        1,429        1,015
    Research and development                 425          328          362

    Total stock based compensation
     expense                              $3,388       $2,865       $2,277



    ALIGN TECHNOLOGY, INC.
    BUSINESS OUTLOOK SUMMARY
    (unaudited)

The outlook figures provided below and elsewhere in this press release are approximate in nature since Align's business outlook is difficult to predict. Align's future performance involves numerous risks and uncertainties and the company's results could differ materially from the outlook provided. Some of the factors that could affect Align's future financial performance and business outlook are set forth under "Forward Looking Information" above in this press release.

    Financials (including reconciliation of GAAP to non-GAAP financial
     measures)
    (in millions, except per share amounts and percentages)

                              GAAP            Adjustment          Non-GAAP
    Revenue
        Q4 2007           $69.5 - $72.2           --            $69.5 - $72.2
        FY 2007          $281.3 - $284.0          --           $281.3 - $284.0

    Gross Profit
        Q4 2007           $50.4 - $52.8         $0.3(a)         $50.7 - $53.1
        FY 2007          $206.3 - $208.7        $1.0(a)        $207.3 - $209.7

    Gross Margin
        Q4 2007           72.5% - 73.1%      0.4% - 0.5%(a)     73.0% - 73.5%
        FY 2007           73.3% - 73.5%      0.3% - 0.4%(a)     73.7% - 73.8%

    Operating Expenses
        Q4 2007           $46.4 - $47.3      $3.0 - $3.1(a)     $43.3 - $44.3
        FY 2007          $173.5 - $174.4       $9.4(a),(b)     $164.1 - $165.0

    Net Profit
        Q4 2007            $4.7 - $6.3         $3.4(a),(c)       $8.1 - $9.7
        FY 2007           $34.8 - $36.4     $10.0(a),(b),(c)    $44.8 - $46.4

    Net Profit per Diluted Share
        Q4 2007           $0.06 - $0.09      $0.04 - $0.05      $0.11 - $0.13
        FY 2007           $0.49 - $0.51          $0.14          $0.63 - $0.65

    (a) Non-cash stock-based compensation
    (b) Includes Patient First Program credit of $1.8 million
    (c) Tax impacts on Non-GAAP adjustments.


    Business Metrics
                                                 4Q 2007              FY 2007
    Channel as a % of Revenue
        U.S. Orthodontists - Full                   28%                 29%
        U.S. GP Dentists - Full                     42%                 43%
        International Invisalign                    17%                 16%
        Invisalign Express                           8%                  8%
        Training/Other                               4%                  4%
    Case Shipments                            50K - 52K     202.1K - 204.1K
    Blended ASP, excl Express                    $1,430              $1,430
    Blended ASP, incl Express                    $1,330              $1,330
    Cash                                    $115 - $120         $115 - $120
    DSO                                        ~56 days            ~56 days
    Capex                                                    $8.0M - $10.0M
    Depreciation & Amortization                             $13.0M - $14.0M



    Investor Relations Contact
    Shirley Stacy
    Align Technology, Inc.
    (408) 470-1150
    sstacy@aligntech.com

    Press Contact
    Shannon Mangum Henderson
    Ethos Communication, Inc.
    (678) 540-9222
    align@ethoscommunication.com


SOURCE Align Technology, Inc.

http://www.invisalign.com

Copyright (C) 2007 PR Newswire. All rights reserved

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