Washington, DC 20549



to Section 13 or 15(d) of the

Securities Exchange Act of 1934


Date of report (Date of earliest event reported) January 29, 2019



(Exact Name of Registrant as Specified in Its Charter)



(State or Other Jurisdiction of Incorporation)


0-32259 94-3267295
(Commission File Number) (IRS Employer Identification No.)
2820  Orchard Parkway, San Jose, California 95134
(Address of Principal Executive Offices) (Zip Code)


(408) 470-1000

(Registrant’s Telephone Number, Including Area Code)


Not applicable

(Former Name or Former Address, if Changed Since Last Report)


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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter)


Emerging growth company ☐


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On January 29, 2019, Align Technology, Inc. ("Align") is issuing a press release and holding a conference call regarding its financial results for its fourth quarter and year ended December 31, 2018. The full text of the press release is furnished as Exhibit 99.1 to this Form 8-K. 

This information shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. 

ITEM 9.01 Financial Statements and Exhibits


(d) Exhibits


Exhibit No. Description
99.1 Press Release of Align Technology, Inc. announcing its fourth quarter and year ended December 31, 2018 financial results









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


Dated: January 29, 2019 Align Technology, INC.
  By: /s/Roger E. George                                        
  Roger E. George
  Sr. Vice President, Chief Legal and Regulatory Officer










Exhibit No. Description
99.1 Press Release of Align Technology, Inc. announcing fourth quarter and year ended December 31, 2018 financial results


Exhibit 99.1




Align Technology Zeno Group
Madelyn Homick Sarah Johnson
(408) 470-1180 (828) 551-4201
mhomick@aligntech.com sarah.johnson@zenogroup.com





2018 revenues up 33.5% to a record $2.0 billion
2018 Invisalign volume of 1.2 million cases up 31.9% and iTero scanner volume up 77.2%
2018 operating margin of 23.7% and diluted EPS of $4.92
2018 Invisalign volume in Americas and International regions up 24.2% and 45.0%, respectively
Q4 total revenues up 26.7% year-over-year to a record $534.0 million, and diluted EPS of $1.20
Q4 Invisalign volume up 30.9% year-over-year to 333.8 thousand cases
Q4 scanner and services revenues up 54.8% year-over-year to $88.4 million
Q4 operating income up 9.9% year-over-year to $120.5 million or operating margin of 22.6%


SAN JOSE, Calif., January 29, 2019 -- Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the fourth quarter (Q4’18) and year ended December 31, 2018 (FY 2018). Q4’18 Invisalign volume was 333.8 thousand cases, up 30.9% year-over-year. For the Americas and International regions, Q4’18 Invisalign volume was up 21.7% and 45.3% year-over-year, respectively. Q4’18 Invisalign volume for teenage patients was 87.1 thousand cases, up 37.3% year-over-year. Q4’18 total revenues were $534.0 million, up 26.7% year-over-year, and Q4’18 scanner and services revenues were $88.4 million, up 54.8% year-over-year. Q4’18 operating income of $120.5 million was up 9.9% year-over-year resulting in an operating margin of 22.6%. Q4’18 net profit was $97.4 million, or $1.20 per diluted share.


For 2018, record Invisalign revenues were $1.7 billion, up 29.4% year-over-year with Invisalign case shipments of 1.2 million, up 31.9% year-over-year. 2018 iTero revenues were $275.0 million, up 67.5% year-over-year with record volume, up 77.2% year-over-year. 2018 Invisalign cases for teenage patients were 333.1 thousand, up 40.3% year-over-year. For 2018, total revenues were $2.0 billion, up 33.5% year-over-year, and net profit was $400.2 million, or $4.92 per diluted share.


Commenting on Align’s Q4 and 2018 results, Align Technology President and CEO Joe Hogan said, “Our fourth quarter was a strong finish to a great year. Q4 revenues were better than expected reflecting higher Invisalign ASPs and volume growth of 31% year-over-year, as well as another record quarter for our iTero scanners with revenue up 55% year-over-year. Q4 sequential growth was driven by a strong quarter for EMEA with record growth from teens, as well as continued traction with Invisalign Lite and Invisalign Go. Q4 operating margin of 22.6% reflects higher doctor training and manufacturing costs, as well as higher legal fees than anticipated, partially offset by a sequential improvement in Invisalign ASPs.”



Align Technology, Inc. 2820 Orchard Pkwy, San Jose, CA 95134

Tel: (408) 470-1000 Fax: (408) 470-1010



Align Technology Announces Fourth Quarter and 2018 Results


Hogan continued, “We achieved record revenues of nearly $2.0 billion for the year and had over 1.2 million people start treatment with Invisalign clear aligners the first time, resulting in our 6th millionth Invisalign patient – a teenager from China. These results reflect record revenues and volumes for both Invisalign and iTero across customer channels and country markets, and continued strength from teens, which grew 40.3%. The total number of teenagers treated with Invisalign this year was over 333 thousand representing 27.1% of our volume. Finally, in 2018, we trained a record number of new Invisalign doctors – nearly 20 thousand worldwide – and more than half of them were international doctors.”


GAAP Summary Financial Comparisons

Fourth Quarter Fiscal 2018

  Q4’18 Q3’18 Q4’17  Q/Q Change  Y/Y Change
Invisalign Case Shipments1 333,800 319,345 255,030 +4.5% +30.9%
Net Revenues $534.0M $505.3M $421.3M +5.7% +26.7%
    Clear Aligner2 $445.6M $427.1M $364.2M +4.3% +22.4%
    Scanner & Services $88.4M $78.2M $57.1M +13.0% +54.8%
Net Profit $97.4M $100.9M $10.3M (3.4)% +848.9%
Diluted EPS3 $1.20 $1.24 $0.13 $(0.04) $1.07


Fiscal 2018

      2018 2017  Y/Y Change
Invisalign Case Shipments1     1,228,065 931,045 +31.9%
Net Revenues     $1,966.5M $1,473.4M +33.5%
    Clear Aligner2     $1,691.5M $1,309.3M +29.2%
    Scanner & Services     $275.0M $164.2M +67.5%
Net Profit     $400.2M $231.4M +72.9%
Diluted EPS3     $4.92 $2.83 +$2.09

Note: Changes and percentages are based on actual values and may affect totals due to rounding

1 Invisalign shipment figures do not include SmileDirectClub aligners

2 Clear aligner revenue includes revenues from Invisalign clear aligners and SmileDirectClub aligners

3 Q4’17 includes deemed repatriation tax impact of $1.06


As of December 31, 2018, Align had $744.5 million in cash, cash equivalents and marketable securities compared to $761.5 million as of December 31, 2017. During Q4’18, we repurchased $50.0 million of our stock against our stock buy-back authorizations and have $500.0 million still available for repurchase under the May 2018 Repurchase Program.


2018 Business Highlights

The following list highlights Align’s key announcements over the past year:


Invisalign and iTero Intraoral Scanner

·Launched Invisalign treatment with mandibular advancement in the U.S. for teen Class II treatment following FDA approval.


·Introduced Invisalign First clear aligners worldwide for treatment of growing children.



Align Technology Announces Fourth Quarter and 2018 Results

·Expanded the Invisalign product portfolio with new options and greater flexibility for a broader range of patients.


·Launched the new Invisalign Go product with a more user-friendly iTero chair side experience.


·Announced multiple industry awards for iTero Element 2 and iTero Element Flex scanners, including 2018 DrBicuspid.com Dental Excellence Award and 2018 GOOD DESIGN® Award.


·Entered into multi-year agreements with both Aspen Dental and Heartland Dental for iTero Element scanners in their U.S. locations.


·Expanded the iTero Element portfolio with the launch of the iTero Element 2 and the iTero Element Flex scanners, along with new functionality connectivity to exocad and Dentrix.


·Began marketing the iTero Element intraoral scanner in China.


·Announced the commercial availability of Vivera Retainers with Precision Bite Ramps, the first retainers in the market that can be customized to provide additional support after deep bite correction.


Invisalign Experience Program


·Expanded the interactive brand experience program that was piloted in late 2017, and added eight new stores in major U.S. cities in the fourth quarter of 2018 to end the year with twelve stores in the U.S.


·Announced the Invisalign Experience Branded Practice Pilot (doctor owned pilot). In late 2018, Align partnered with a few Invisalign doctors in select U.S. cities to pilot Invisalign Experience branded practices to test new ways to reach consumers and connect them directly with doctors to start Invisalign treatment.


Patient Milestones


·Reached 6th millionth Invisalign patient milestone with a teenage patient from China.


·Announced the one millionth Invisalign case for the Europe, Middle East and Africa (EMEA) region.  


International Expansion


·Opened the first Invisalign treatment planning facility in Europe, located in Cologne, Germany.


·Launched a new digital treatment planning facility and education center in Madrid, Spain.


Research and Awards


·Announced eleven recipients of research grants under Align’s 2018 Research Award Program, and opened the 2019 Research Award Program to support clinical and scientific dental research in universities across the globe. 


·Launched the Orthodontic Aligner Fellowship Certificate Program, in collaboration with DentalXP, a global dental education provider on August 6, 2018.



Align Technology Announces Fourth Quarter and 2018 Results



·Announced entering into an accelerated stock repurchase agreement to repurchase $50.0 million of Align's common stock as part of Align's $600.0 million stock repurchase program announced on May 23, 2018. 


·Announced that on August 22, 2018, the United States Court of Appeals for the Federal Circuit vacated the Patent Trial and Appeal Board’s decision invalidating certain claims of Align’s patent no. 6,699,037, entitled “Method and System for Incrementally Moving Teeth.”


Q1 2019 Business Outlook

For the first quarter of 2019 (Q1’19), Align provides the following guidance:


·Net revenues in the range of $525.0 million to $535.0 million, up approximately 20% to 22% over the same period a year ago.


·Invisalign case shipments in the range of 340 thousand to 345 thousand, up approximately 25% to 27% over the same period a year ago.


·Operating margin in the range of 15.1% to 16.1%.


·Diluted EPS in the range of $0.78 to $0.84.


Align Web Cast and Conference Call

Align will host a conference call today, January 29, 2019 at 4:30 p.m. ET, 1:30 p.m. PT, to review its fourth quarter and year ended 2018 results, discuss future operating trends and the business outlook. The conference call will also be web cast live via the Internet. To access the webcast, go to the “Events & Presentations” section under Company Information on Align’s Investor Relations web site at http://investor.aligntech.com. To access the conference call, please dial 201-689-8261. An archived audio web cast 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 conference number 13685779 followed by #. For international callers, please dial 201-612-7415 and use the same conference number referenced above. The telephonic replay will be available through 5:30 p.m. ET on February 12, 2019.


About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign® system, the most advanced clear aligner system in the world, and iTero® intraoral scanners and services. Align’s products help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients. Visit www.aligntech.com for more information.


For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about iTero digital scanning system, please visit www.itero.com.



Align Technology Announces Fourth Quarter and 2018 Results

Forward-Looking Statement

This news release, including the tables below, contains forward-looking statements, including statements regarding certain business metrics for the first quarter of 2019, including, but not limited to, anticipated net revenues, gross margin, operating expenses, operating profit, diluted earnings per share, tax rate and case shipments. 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, difficulties predicting customer and consumer purchasing behavior, Align's ability to protect its intellectual property rights, continued compliance with regulatory requirements, competition from existing and new competitors, the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers, the possibility that the development and release of new products does not proceed in accordance with the anticipated timeline, the possibility that the market for the sale of these new products may not develop as expected, or that the expected benefits of new or existing business relationships will not be achieved as anticipated, the risks relating to Align's ability to sustain or increase profitability or revenue growth in future periods while controlling expenses, growth related risks, including excess or constrained capacity at our manufacturing and treat operations facilities and pressure on our internal systems and personnel, the security of customer and/or patient data is compromised for any reason, continued customer demand for our existing and new products, changes in consumer spending habits as a result of, among other things, prevailing economic conditions, levels of employment, salaries and wages and consumer confidence, the timing of case submissions from our doctors within a quarter as well as an increased manufacturing costs per case, acceptance of our products by consumers and dental professionals, foreign operational, political and other risks relating to Align's international manufacturing operations, Align's ability to develop and successfully introduce new products and product enhancements and the loss of key personnel. 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 year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 28, 2018, and its latest Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, which was filed with the SEC on November 1, 2018. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.






Align Technology Announces Fourth Quarter and 2018 Results

(in thousands, except per share data)


   Three Months Ended
December 31,
  Year Ended
December 31,
   2018  2017  2018  2017
Net revenues  $534,020   $421,323   $1,966,492   $1,473,413 
Cost of net revenues   150,924    103,406    518,625    356,466 
Gross profit   383,096    317,917    1,447,867    1,116,947 
Operating expenses:                    
Selling, general and administrative   226,819    182,141    852,404    665,777 
Research and development   35,804    26,170    128,899    97,559 
Total operating expenses   262,623    208,311    981,303    763,336 
Income from operations   120,473    109,606    466,564    353,611 
Interest income   2,249    2,486    8,576    6,948 
Other income (expense), net   (730)   95    (8,489)   4,240 
Net income before provision for income taxes and equity in losses of investee   121,992    112,187    466,651    364,799 
Provision for income taxes**   22,517    103,654    57,723    130,162 
Equity in losses (gains) of investee, net of tax   2,083    (1,731)   8,693    3,219 
Net income  $97,392   $10,264   $400,235   $231,418 
Net income per share:                    
Basic  $1.22   $0.13   $5.00   $2.89 
Diluted  $1.20   $0.13   $4.92   $2.83 
Shares used in computing net income per share:                    
Basic   79,891    80,080    80,064    80,085 
Diluted   80,943    81,863    81,357    81,832 


* During Q1'18, we adopted the ASC 606, "Revenues from Contracts with Customers" using the full retrospective method. The adoption of ASC 606 did not have a material impact on our Condensed Consolidated Statements of Operations presented herein.
** During Q4'17, the U.S. Tax Cuts and Jobs Act was enacted into law and we recorded the tax impacts in our provision for income taxes. 



Align Technology Announces Fourth Quarter and 2018 Results

(in thousands)

    December 31,
    December 31,
Current assets:          
Cash and cash equivalents  $636,899   $449,511 
Marketable securities, short-term   98,460    272,031 
Accounts receivable, net   439,009    324,189 
Inventories   55,641    31,688 
Prepaid expenses and other current assets   72,470    80,948 
Total current assets   1,302,479    1,158,367 
Marketable securities, long-term   9,112    39,948 
Property, plant and equipment, net   521,329    348,793 
Equity method investments   45,913    54,606 
Goodwill and intangible assets, net   81,949    89,068 
Deferred tax assets   64,689    49,334 
Other assets   26,987    43,893 
Total assets  $2,052,458   $1,784,009 
Current liabilities:          
Accounts payable  $64,256   $36,776 
Accrued liabilities   234,679    195,562 
Deferred revenues   393,138    267,713 
Total current liabilities   692,073    500,051 
Income tax payable   78,008    114,091 
Other long-term liabilities   29,486    15,579 
Total liabilities   799,567    629,721 
Total stockholders' equity   1,252,891    1,154,288 
Total liabilities and stockholders' equity  $2,052,458   $1,784,009 


* During Q1'18, we adopted the ASC 606, "Revenues from Contracts with Customers" using the full retrospective method. Condensed Consolidated Balance Sheet as of December 31, 2017 has been recasted to comply with the adoption.




Align Technology Announces Fourth Quarter and 2018 Results

(in thousands)      


   Year Ended
December 31,
   2018  2017
Net cash provided by operating activities  $554,681   $438,539 
Net cash provided by (used in) investing activities   6,927    (251,477)
Net cash used in financing activities   (369,434)   (135,500)
Effect of foreign exchange rate changes on cash, cash equivalents, and restricted cash   (4,733)   5,544 
Net decrease in cash, cash equivalents, and restricted cash   187,441    57,106 
Cash, cash equivalents, and restricted cash at beginning of the period   450,125    393,019 
Cash, cash equivalents, and restricted cash at end of the period  $637,566   $450,125 
*During Q1'18, we adopted ASU 2016-18, "Statement of Cash Flows - Restricted Cash" on a retrospective basis. Condensed Consolidated Statement of Cash Flows for the year ended December 31, 2017 has been recasted to comply with the adoption. 



Align Technology Announces Fourth Quarter and 2018 Results


   Q4  Fiscal  Q1  Q2  Q3  Q4  Fiscal
   2017  2017  2018  2018  2018  2018  2018
Invisalign Average Selling Price (ASP):                     
Worldwide ASP   $1,305   $1,295   $1,310   $1,315   $1,230   $1,235   $1,270 
International ASP  $1,400   $1,375   $1,435   $1,425   $1,340   $1,295   $1,370 
Invisalign Cases Shipped by Geography:                                   
Americas   155,625    586,205    166,665    181,425    190,615    189,410    728,115 
International   99,405    344,840    105,570    121,260    128,730    144,390    499,950 
   Total Cases Shipped   255,030    931,045    272,235    302,685    319,345    333,800    1,228,065 
       YoY % growth   34.2%   31.4%   30.8%   30.5%   35.3%   30.9%   31.9%
       QoQ % growth   8.0%        6.7%   11.2%   5.5%   4.5%     
Number of Invisalign Doctors Cases Were Shipped To:                                   
Americas   26,480    38,230    27,105    28,280    28,890    29,215    38,640 
International   18,505    26,175    19,700    21,805    23,270    25,475    31,300 
   Total Doctors Cases Shipped To   44,985    64,405    46,805    50,085    52,160    54,690    69,940 
Invisalign Doctor Utilization Rates**:                                   
North America   6.0    15.8    6.3    6.6    6.9    6.7    19.6 
  North American Orthodontists   14.0    46.6    15.3    16.4    17.4    16.5    58.4 
  North American GP Dentists   3.3    8.2    3.4    3.6    3.5    3.6    9.9 
International   5.4    13.2    5.4    5.6    5.5    5.7    16.0 
   Total Utilization Rates   5.7    14.5    5.8    6.0    6.1    6.1    17.6 
Number of Invisalign Doctors Trained***:                                   
Americas   1,760    6,615    1,630    1,880    2,085    2,290    7,885 
International   2,400    10,215    2,645    3,300    2,845    2,980    11,770 
   Total Doctors Trained Worldwide   4,160    16,830    4,275    5,180    4,930    5,270    19,655 
   Total to Date Worldwide   132,300    132,300    136,575    141,755    146,685    151,955    151,955 


Note: Historical public data may differ due to rounding. Additionally, rounding may effect totals. Effective Q1'18, Americas region includes North America and LATAM. International region includes EMEA and APAC. We have recasted historical data to reflect the change.
* Invisalign business metrics exclude SmileDirectClub aligners. 
** # of cases shipped / # of doctors to whom cases were shipped. LATAM utilization rate is not separately disclosed, but included in the total utilization rates. 
***2018 and 2017 adjusted to reflect Americas doctors trained for Invisalign iGo 




(in thousands)


   Q4  Fiscal  Q1  Q2  Q3  Q4  Fiscal
   2017  2017  2018  2018  2018  2018  2018
Stock-based Compensation (SBC)                                   
SBC included in Gross Profit  $804   $3,330   $881   $900   $966   $948   $3,695 
SBC included in Operating Expenses   14,026    55,524    14,949    15,990    18,232    17,897    67,068 
   Total SBC Expense  $14,830   $58,854   $15,830   $16,890   $19,198   $18,845   $70,763 



Align Technology Announces Fourth Quarter and 2018 Results

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.  
Financial Outlook      
(in millions, except per share amounts and percentages)      
    Q1'19 Guidance  
Net Revenues   $525.0 - $535.0  
Gross Margin   70.3% - 71.0%  
Operating Expenses   $289.8 - $293.8  
Operating Margin   15.1% - 16.1%  
Net Income per Diluted Share   $0.78 - $0.84  
Business Metrics:   Q1'19  
Case Shipments   340.0K - 345.0K  
Capital Expenditure   $19M - $20M  
Depreciation & Amortization   $60M - $65M  
Diluted Shares Outstanding   80.9M (2)
Stock Based Compensation Expense   $19.9M  
Effective Tax Rate   ~16% (1)
(1) Includes excess tax benefits related to share-based compensation expense pursuant to ASU 2016-09
(2) Excludes any stock repurchases during the quarter