SANTA CLARA, Calif., Jan 30, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Align Technology, Inc. (Nasdaq: ALGN), the inventor of Invisalign(R), a proprietary method of straightening teeth without wires and brackets, today reported financial results for the fourth quarter and full year of 2006. Total revenues for the fourth quarter of 2006 were $55.2 million, compared to $51.2 million in the fourth quarter of 2005, an increase of 7.9 percent. For fiscal year 2006, Align reported revenues of $206.4 million, compared to $207.1 million for fiscal year 2005, a decrease of 0.4 percent.
"2006 was eventful and productive," stated Thomas M. Prescott, President and CEO of Align Technology. "We resolved our legal disputes with OrthoClear and refocused our efforts on product development, customer service and market expansion. Overall, we shipped a record number of cases and our base of doctors grew tremendously. We expect 2007 to be the year we restage growth, introduce products that meet the unique needs of the Orthodontists and GPs and continue our path to profitability."
Revenue was $55.2 million for the fourth quarter, an increase of 7.9% from the fourth quarter of 2005, and $206.4 million for the year ended December 31, 2006, a decrease of 0.4% over the prior year. In the fourth quarter, revenue per channel was:
* $17.4 million for U.S. Ortho, including $2.0 million for Invisalign Express; * $24.5 million for U.S. GP, including $2.9 million for Invisalign Express; * $9.6 million for International; and * $3.7 million for Other. Key metrics include: * 3,700 U.S. Orthos, 9,000 U.S. GPs, and 2,100 International doctors submitted cases in the fourth quarter. Also in the fourth quarter, cases were shipped to 3,400 U.S. Orthos, 7,900 U.S. GPs and 1,900 International doctors. * Utilization in the fourth quarter of 2006 was 4.2 for U.S. Orthos, 2.4 for U.S. GPs, and 2.9 for International. Utilization in the ortho channel declined because a large number of doctors, who had not started cases in the previous year, started new Invisalign cases in the fourth quarter. Utilization was flat in the U.S. GP channel and slightly up in international. * In the fourth quarter, worldwide average selling price (ASP) for Invisalign was $1,320. Excluding Invisalign Express, worldwide ASP was $1,445. * Total number of cases shipped in fiscal year 2006 increased 22% to 150,100. Included in this were 36,600 Invisalign Express cases. * Doctors trained worldwide in fiscal year 2006 increased by 5,000, including 3,800 U.S. GP dentists, to a cumulative total of 40,800. * Since product inception, 28,700 doctors worldwide have used Invisalign: 6,200 U.S. Orthos; 17,200 U.S. GPs; and 5,300 International doctors. 84 percent of these doctors have started more than one case.
A full list of quarterly metrics is available in the Fact Sheet following the financial tables of this release. Additionally, quarterly metric information for the last 8 quarters is available on Align's website at investor.aligntech.com.
Operating results reflect stock-based compensation expense of $2.2 million for Q4 and $8.9 million for full year 2006 due to the implementation of FAS 123( R ) in the first quarter of 2006. It also reflects $14.3 million of one- time costs incurred from our agreement with OrthoClear including settlement costs and costs associated with the Patients First Program. These items have been excluded in the non-GAAP financials. A reconciliation of GAAP (U.S. generally accepted accounting principles) to non-GAAP results and outlook is contained in the tables below.
Fourth Quarter 2006 Operating Results Key GAAP operating results for the fourth quarter of 2006 include: * Gross margin was 68.8 percent, compared to 67.3 percent in the fourth quarter 2005. * Operating expenses were $56.1 million, compared to $33.8 million in the fourth quarter 2005. Operating expense in the fourth quarter 2006 includes a one-time charge of $14.3 million. This includes $6.0 million in settlement costs related to the $20 million paid to OrthoClear ($14.0 million was capitalized and will be amortized over 5 years) and $8.3 million for the cost of completing the Patients First Program cases. * Net loss was $17.3 million, compared to a net profit of $528,000 in the fourth quarter 2005. * Net loss per share was $0.27, compared to EPS of $0.01 in the fourth quarter 2005. Key non-GAAP operating results for the fourth quarter of 2006 include: * Gross margin was 69.2 percent, compared to 67.3 percent in the fourth quarter 2005. * Operating expenses were $39.7 million, compared to $33.8 million in the fourth quarter 2005. * Net loss was $764,000, compared to a net profit of $528,000 in the fourth quarter 2005. * Net loss per share was $0.01, compared to EPS of $0.01 in the fourth quarter 2005. Full Year 2006 Operating Results Key GAAP operating results for the full year 2006 include: * Gross margin was 68.6 percent, compared to 69.2 percent in 2005. * Operating expenses were $179.1 million, compared to $140.9 million in 2005. Operating expenses include a one-time charge for the Patients First Program and settlement costs taken in the fourth quarter 2006 as described above. 2006 operating expense also includes $19.6 million of legal and other OrthoClear-related expenses. * Net loss was $35.0 million, compared to a net profit of $1.4 million in 2005. * Net loss per share was $0.55, compared to EPS of $0.02 in 2005. Key non-GAAP operating results for the full year 2006 include: * Gross margin was 68.9 percent, compared to 69.2 percent in 2005. * Operating expenses were $156.6 million, compared to $140.9 million in 2005. * Net loss was $11.7 million, compared to a net profit of $1.4 million in 2005. * Net loss per share was $0.19, compared to EPS of $0.02 in 2005. Liquidity and Capital Resources
As of December 31, 2006, Align had $64.1 million in cash, cash equivalents, marketable securities and restricted cash, compared to $74.4 million as of December 31, 2005. In the third quarter 2006, Align borrowed $15.0 million from its credit facility. $11.5 million remains outstanding.
Patients First Program Update
As of December 31, 2006, of the 30,500 registered cases, 19,000 completed treatment forms have been received and 3,600 cases were shipped.
Business Outlook for the First Quarter 2007 and Full Year 2007
For the first quarter 2007, Align Technology expects revenues between $56.8 and $59.8 million and GAAP earnings/loss per share between ($0.02) and $0.00. Non-GAAP EPS is expected to be between $0.02 and $0.04.
For the fiscal year 2007, Align Technology expects revenues between $240.0 and $255.0 million and GAAP earnings/loss per share between ($0.04) and $0.07. Non-GAAP EPS for fiscal year 2007 is expected to be between $0.15 and $0.27.
A more comprehensive business outlook section, 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 webcast and conference call today, January 30, 2007 at 10:00 a.m. EST, 7:00 a.m. PST, to review the fourth quarter and fiscal year 2006 results and discuss future operating trends and guidance. To access the webcast, click on "Webcasts & Presentations" 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 web cast will be available beginning approximately one hour after the call's conclusion and will remain available through 5:30 p.m. EDT on January 29, 2008. Additionally, a telephonic replay of the call can be accessed by dialing (877) 660-6853 with account number 292 followed by # and conference number 227475 followed by #. The replay may 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. EDT on February 13, 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 www.invisalign.com or call 1-800-INVISIBLE.
About non-GAAP Financial Measures
To supplement our consolidated financial statements, which statements are prepared and presented in accordance with GAAP, we use the following non-GAAP financial measures: non-GAAP gross profit, profit (loss) from operations, net profit (loss) and certain expenses (including sales and marketing, general and administrative and research and development), which exclude stock-based compensation and the Patients First Program and settlement costs. 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" 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, such as the Patients First Program and settlement costs. 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.
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 first quarter and full year of 2007, including anticipated percentage of revenue by channel, case shipments and average selling prices, and statements by Mr. Prescott regarding introduction of new products and anticipated return to profitability in fiscal 2007. 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, including expenses related to the OrthoClear settlement, customer demand for Invisalign, 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, 2005, which was filed with the Securities and Exchange Commission on March 1, 2006, and its Quarterly Reports on Form 10-Q. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Investor Relations Contact: Press Contact: Barbara Domingo Shannon Henderson Align Technology, Inc. Ethos Communications, Inc. (408) 470-1000 (678) 540-9222 firstname.lastname@example.org email@example.com ALIGN TECHNOLOGY, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended Year Ended (in thousands, except Dec. 31, Dec. 31, Dec. 31, Dec. 31, per share data) 2006 2005 2006 2005 Revenues $55,191 $51,164 $206,354 $207,125 Cost of revenues 17,197 16,711 64,775 63,784 Gross profit 37,994 34,453 141,579 143,341 Operating expenses: Sales and marketing 22,121 18,570 81,993 80,068 General and administrative 14,649 11,293 64,305 42,242 Research and development 4,948 3,927 18,474 18,585 Patients First Program and settlement costs 14,343 -- 14,343 -- Total operating expenses 56,061 33,790 179,115 140,895 Profit (Loss) from operations (18,067) 663 (37,536) 2,446 Interest and other income, net 1,008 255 3,401 283 Provision for income taxes (210) (390) (828) (1,316) Net profit (loss) $(17,269) $528 $(34,963) $1,413 Net profit (loss) per share - basic $(0.27) $0.01 $(0.55) $0.02 - diluted $(0.27) $0.01 $(0.55) $0.02 Shares used in computing net profit (loss) per share - basic 64,252 62,045 63,246 61,644 - diluted 64,252 63,247 63,246 63,152 ALIGN TECHNOLOGY, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) December 31, December 31, (in thousands) 2006 2005 ASSETS Current assets: Cash and cash equivalents $55,113 $74,219 Restricted cash 93 150 Marketable securities, short-term 8,931 - Accounts receivable, net 33,635 29,305 Inventories, net 3,090 2,930 Other current assets 7,227 4,982 Total current assets 108,089 111,586 Property and equipment, net 26,904 26,427 Goodwill and intangible assets, net 14,303 1,296 Other long-term assets 2,262 2,801 Total assets $151,558 $142,110 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Line of credit $11,500 $-- Accounts payable 5,034 2,489 Accrued liabilities 40,307 29,372 Deferred revenue 10,942 16,747 Total current liabilities 67,783 48,608 Other long term liabilities 219 64 Total liabilities 68,002 48,672 Total stockholders' equity 83,556 93,438 Total liabilities and stockholders' equity $151,558 $142,110 ALIGN TECHNOLOGY, INC. RECONCILIATION OF GAAP TO NON-GAAP CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) Three Months Ended Three Months Ended December 31, 2006 December 31, 2005 Adjust- Non Adjust- Non Reported ments GAAP Reported ments GAAP Revenues $55,191 $-- $55,191 $51,164 $-- $51,164 Cost of revenues 17,197 (185)(a) 17,012 16,711 -- 16,711 Gross profit 37,994 185 38,179 34,453 -- 34,453 Operating expenses: Sales and marketing 22,121 (737)(a) 21,384 18,570 -- 18,570 General and administrative 14,649 (922)(a) 13,727 11,293 -- 11,293 Research and development 4,948 (318)(a) 4,630 3,927 -- 3,927 Patients First Program and settlement costs 14,343 (14,343) -- -- -- -- Total operating expenses 56,061 (16,320) 39,741 33,790 -- 33,790 Profit (Loss) from operations (18,067) 16,505 (1,562) 663 -- 663 Interest and other income, net 1,008 -- 1,008 255 -- 255 Provision for income taxes (210) -- (210) (390) -- (390) Net profit (loss) $(17,269) $16,505 $(764) $528 $-- $528 Net profit (loss) per share - basic $(0.27) $(0.01) $0.01 $0.01 - diluted $(0.27) $(0.01) $0.01 $0.01 Shares used in computing net profit (loss) per share - basic 64,252 64,252 62,045 62,045 - diluted 64,252 64,252 63,247 63,247 (a) Non cash stock-based compensation included in cost of sales and operating expenses. ALIGN TECHNOLOGY, INC. RECONCILIATION OF GAAP TO NON-GAAP CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) Year Ended Year Ended December 31, 2006 December 31, 2005 Adjust- Non Adjust- Non Reported ments GAAP Reported ments GAAP Revenues $206,354 $-- $206,354 $207,125 $-- $207,125 Cost of revenues 64,775 (700)(a) 64,075 63,784 -- 63,784 Gross profit 141,579 700 142,279 143,341 -- 143,341 Operating expenses: Sales and marketing 81,993 (2,862)(a) 79,131 80,068 (6)(a) 80,062 General and administrative 64,305 (4,054)(a) 60,251 42,242 (6)(a) 42,236 Research and development 18,474 (1,294)(a) 17,180 18,585 -- 18,585 Patients First Program and settlement costs 14,343 (14,343) -- -- -- -- Total operating expenses 179,115 (22,553) 156,562 140,895 (12) 140,883 Profit (Loss) from operations (37,536) 23,253 (14,283) 2,446 12 2,458 Interest and other income, net 3,401 -- 3,401 283 -- 283 Provision for income taxes (828) -- (828) (1,316) -- (1,316) Net profit (loss) $(34,963) $23,253 $(11,710) $1,413 $12 $1,425 Net profit (loss) per share - basic $(0.55) $(0.19) $0.02 $0.02 - diluted $(0.55) $(0.19) $0.02 $0.02 Shares used in computing net profit (loss) per share - basic 63,246 63,246 61,644 61,644 - diluted 63,246 63,246 63,152 63,152 (a) Non cash stock-based compensation included in cost of sales and operating expenses ALIGN TECHNOLOGY, INC. FACT SHEET
The following information highlights business metrics for Align's fourth quarter of 2006. For prior quarter information, please refer to the Investor Relations website at http://investor.aligntech.com .
(rounded to the nearest hundred, except in utilization, ASPs and percentage amounts) Cases Delivered 4Q 2006 U.S. Orthodontists - Full 11,700 U.S. Orthodontists - Invisalign Express 2,700 U.S. GP dentists - Full 15,100 U.S. GP dentists - Invisalign Express 4,000 International - Full 5,400 International - Invisalign Express 100 Total Cases Delivered 39,000 Patients First Program Information 4Q 2006 Final number of OC Cases 33,100 Cases registered 30,500 Completed treatment forms received 19,000 Cases shipped 3,600 Doctors Trained 4Q 2006 Cumulative Total U.S. Orthodontists -- 8,000 U.S. GP dentists 1,300 22,000 International 400 10,800 Total Doctors Trained 1,700 40,800 Submitting Doctors 4Q 2006 U.S. Orthodontists 3,700 U.S. GP dentists 9,000 International 2,100 Total Submitting Doctors 14,800 Doctors Cases Are Shipped To 4Q 2006 U.S. Orthodontists 3,400 U.S. GP dentists 7,900 International 1,900 Total Submitting Doctors 13,200 Doctors Starting Invisalign Treatment Since Inception U.S. Orthodontists 6,200 U.S. GP dentists 17,200 International 5,300 Total Doctors Starting Invisalign Treatment 28,700 % of Multiple-Case Doctors Since Inception U.S. Orthodontists 88% U.S. GP dentists 86% International 73% Total Worldwide 84% Doctor Utilization* 4Q 2006 U.S. Orthodontists 4.2 U.S. GP dentists 2.4 International 2.9 * Doctor Utilization = # of cases / # of doctors cases are shipped to Blended ASP incl. Invisalign Express 4Q 2006 U.S. Orthodontists 1,215 U.S. GP dentists 1,285 International 1,725 Total Worldwide ASP 1,320 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) 1Q 2007 GAAP Adjustment Non-GAAP Revenue $56.8-59.8 $56.8-59.8 Gross Margin 69.3-70.2% 0.3-0.4% (a) 69.6-70.6% Operating Expense $40.5-42.2 $2.3-2.6 (a) $38.2-39.6 Net Profit (Loss) ($1.2)-$0.1 $2.5-2.8 (a) $1.3-2.9 Net Profit (Loss) per Share ($0.02)-$0.00 $0.04 (a) $0.02-0.04 FY 2007 GAAP Adjustment Non-GAAP Revenue $240.0-255.0 $240.0-255.0 Gross Margin 68.7-70.1% 0.50% (a) 69.2-70.6% Operating Expense $167.9-175.5 $11.6-12.5 (a) $156.3-163.0 Net Profit (Loss) ($2.7)-$4.5 $12.7-13.7 (a) $10.0-18.2 Net Profit (Loss) per Share ($0.04)-$0.07 $0.19-0.20 (a) $0.15-0.27 (a) Non cash stock-based compensation included in cost of sales and operating expenses Business Metrics 1Q 2007 FY 2007 Channel as a % of Revenue U.S. Orthodontists - Full 30% 31% U.S. GP Dentists - Full 41% 39% International 15% 14% Invisalign Express 9% 12% Case Shipments 41.6-43.5K 182.7-190.0K Blended ASP, excl Express $1,425-$1,440 $1,410-$1,425 Blended ASP, incl Express $1,305-$1,315 $1,260-$1,280 Cash $54.0-58.0M DSO ~55 days Capex $12.0-14.0M Depreciation & Amortization $13.0-14.0M
SOURCE Align Technology, Inc.
investors, Barbara Domingo of Align Technology, Inc., +1-408-470-1000, or firstname.lastname@example.org; or media, Shannon Henderson of Ethos Communications, Inc., +1-678-540-9222, or email@example.com, for Align
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