Exhibit 99.1

 

 

 

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

 

 

ALIGN TECHNOLOGY ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS

Achieves 7 Millionth Invisalign Patient Milestone

 

Q2 revenues up 22.5% year-over-year to a record $600.7 million
Q2 Invisalign volume up 24.6% year-over-year to 377.1 thousand cases
Q2 scanner and services revenues up 82.4% year-over-year to $104.0 million
Q2 Invisalign cases for teenage patients up 32.2% year-over-year to 103.7 thousand
Q2 operating income of $176.5 million includes $51.0 million benefit from Straumann settlement
Q2 net profit of $147.1 million and $1.83 diluted EPS

 

SAN JOSE, Calif., July 24, 2019 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the second quarter ended June 30, 2019. Q2’19 Invisalign volume was 377.1 thousand cases, up 24.6% year-over-year. For the Americas and International regions, Q2’19 Invisalign volume was up 16.5% and 36.7% year-over-year, respectively. Q2’19 Invisalign volume for teenage patients was 103.7 thousand cases, up 32.2% year-over-year. Q2’19 total revenues were $600.7 million, up 22.5% year-over-year, and Q2’19 scanner and services revenues were $104.0 million, up 82.4% year-over-year.

 

Q2’19 operating income of $176.5 million was up 43.8% year-over-year resulting in an operating margin of 29.4%. Q2’19 net profit was $147.1 million, or $1.83 per diluted EPS. Q2’19 operating expense included a $51.0 million benefit from the ClearCorrect settlement with Straumann, which increased Q2 operating margin by approximately 8 points and benefited EPS by $0.57, respectively.

 

Commenting on Align’s second quarter results and outlook for the third quarter, Align Technology President and CEO Joe Hogan said, “Our second quarter revenues were at the high-end of our guidance, reflecting Invisalign volume growth primarily from international doctors, as well as very strong sales from iTero scanner and services. Q2 Invisalign volumes were up 24.6% year-over-year reflecting continued adoption from teenage and younger patients, as well as increased utilization among orthodontists and expansion of our customer base which totaled 60,000 active doctors worldwide. In Q2, total Invisalign case shipments were lower than expected, primarily due to a softness in China related to a tougher consumer environment and slower growth in young adult case in North America. Given the uncertainty in China, our outlook for the third quarter reflects a more cautious view for growth in the Asia Pacific region.”

 

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

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

WWW.ALIGNTECH.COM

 

 

Align Technology Announces Second Quarter 2019 Results

 

 

GAAP Summary Financial Comparisons

Second Quarter Fiscal 2019

     Q2’19      Q1’19      Q2’18    Q/Q Change  Y/Y Change
Invisalign Case Shipments1   377,145    349,195    302,685   +8.0%  +24.6%
Net Revenues  $600.7M   $549.0M   $490.3M   +9.4%  +22.5%
Clear Aligner2  $496.7M   $469.2M   $433.3M   +5.9%  +14.6%
Scanner & Services  $104.0M   $79.8M   $57.0M    +30.4%   +82.4%
Net Profit3, 4  $147.1M   $71.8M   $106.1M   +104.8%  +38.7%
Diluted EPS3, 4  $1.83   $0.89   $1.30   +$0.94  +$0.53

 

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 Q1’19 results include impairments and other charges of $29.8 million related to closing Invisalign Stores as a result of the arbitrator’s decision regarding SmileDirectClub announced March 5, 2019.

4 Q2’19 results include a $51.0 million gain from Straumann litigation settlement.

 

As of June 30, 2019, Align had $765.9 million in cash, cash equivalents and marketable securities compared to $732.5 million as of March 31, 2019. In May 2019, we purchased on the open market approximately 0.2 million shares of our common stock at an average price of $307.48 per share, including commission, for an aggregate purchase price of $49.5 million. We have $400.5 million remaining available for repurchase under the May 2018 Repurchase Program.

 

Announcements and Highlights

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

Corporate

During the quarter, Align shipped its 7 millionth Invisalign patient who is a young child in the U.S. being treated with Invisalign First.
Announced that Align and Straumann Group terminated discussions concerning a possible development and distribution agreement that was disclosed as part of the patent settlement agreement announced by the two companies in March of this year. 
Announced that Simon Beard was appointed as senior vice president of the Americas region and Markus Sebastian was promoted to senior vice president of the EMEA region.
Align awarded ten research grants totaling $250,000 as part of its ongoing annual research awards program to universities worldwide.
Announced that Roger E. George, Align senior vice president, chief legal and regulatory officer has retired and that Julie Coletti was appointed to senior vice president and Chief Legal and Regulatory Officer.
Announced that on April 26, 2019, an Administrative Law Judge with the United States International Trade Commission issued an Initial Determination regarding her investigation of 3Shape’s infringement on Align’s patents.

 

 - 2 - 

 

Align Technology Announces Second Quarter 2019 Results

 

Align completed the purchase of the Raleigh office building located in Morrisville, NC. This office serves as the Americas headquarters.

Invisalign and iTero Intraoral Scanner

Launched the new iTero Element Foundation intraoral scanner with restorative software. The iTero Element Foundation extends Align’s portfolio of intraoral scanners with powerful 3D visualization to better meet the needs of doctors, labs and patients.

 

 

Q3 2019 Business Outlook

For the third quarter of 2019 (Q3’19), Align provides the following guidance:

Net revenues in the range of $585 million to $600 million, up approximately 16% to 19% over the same period a year ago
Invisalign case shipments in the range of 370 thousand to 380 thousand, up approximately 16% to 19% over the same period a year ago
Operating margin in the range of 19.8% to 20.5%
Diluted EPS in the range of $1.09 to $1.16
 In addition, we expect to repurchase at least $100 million of our stock in the open market in Q3
 As we continue our operational expansion efforts, we expect CapEx for Q3 to be approximately $50 million to $55 million, and we expect depreciation and amortization to be $24 million to 26 million

 

 

Align Web Cast and Conference Call

Align will host a conference call today, July 24, 2019 at 4:30 p.m. ET, 1:30 p.m. PT, to review its second quarter 2019 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 13691835 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 August 7, 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.

 

 - 3 - 

 

Align Technology Announces Second Quarter 2019 Results

 

Forward-Looking Statement

This news release, including the tables below, contains forward-looking statements, including statements regarding certain business metrics for the third quarter of 2019, including, but not limited to, anticipated net revenues, gross margin, operating expenses, operating profit, capital expenditures, depreciation and amortization, diluted earnings per share, tax rate, case shipments, and our expectations regarding stock repurchases during the quarter. 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, including Align’s predictions related to a tougher consumer demand environment in China, especially for U.S. based products and services, Align’s expectations regarding the continued growth of our international markets, Align's ability to protect its intellectual property rights, continued compliance with regulatory requirements, competition from existing and new competitors, Align’s expectations regarding the sales growth of its intra-oral scanner sales in international markets, its belief that technology features and functionality of the iTero scanners will increase adoption of Invisalign and increase sales of Align’s intra-oral scanners, Align’s expectations regarding the financial and strategic benefits of establishing regional order acquisition, treatment planning and manufacturing facilities, 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, Align’s expectation to incur additional costs related to the planned corporate structure reorganization, the risks relating to Align's ability to sustain or increase profitability or revenue growth in future periods while controlling expenses, the expected impact additional sales representatives will have on our sales in 2019, 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, system integration and implementation issues, 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, 2018, which was filed with the Securities and Exchange Commission (SEC) on February 28, 2019 and its latest Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, which was filed with the SEC on May 2, 2019. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

 

 

 

 

 

 

 

 - 4 - 

 

Align Technology Announces Second Quarter 2019 Results

 

ALIGN TECHNOLOGY, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

                 

   Three Months Ended
June 30,
  Six Month Ended
June 30,
   2019  2018  2019  2018
             
Net revenues  $600,697   $490,259   $1,149,668   $927,183 
                     
Cost of net revenues   168,408    124,677    315,283    234,193 
                     
Gross profit   432,289    365,582    834,385    692,990 
                     
Operating expenses:                    
Selling, general and administrative   267,948    212,087    515,058    411,712 
Research and development   38,851    30,804    76,354    60,395 
Impairments and other charges           29,782     
Litigation settlement gain   (51,000)       (51,000)    
Total operating expenses   255,799    242,891    570,194    472,107 
                     
Income from operations   176,490    122,691    264,191    220,883 
                     
Interest income   3,465    1,917    6,098    4,093 
Other income (expense), net   13,892    (7,099)   8,146    (6,922)
                     
Net income before provision for income taxes and equity in losses of investee   193,847    117,509    278,435    218,054 
                     
Provision for income taxes   43,121    7,703    51,917    10,605 
Equity in losses of investee, net of tax   3,584    3,701    7,528    5,478 
                     
Net income  $147,142   $106,105   $218,990   $201,971 
                     
Net income per share:                    
Basic  $1.84   $1.32   $2.74   $2.52 
Diluted  $1.83   $1.30   $2.71   $2.48 
                     
Shares used in computing net income per share:                    
Basic   79,943    80,216    79,901    80,127 
Diluted   80,590    81,471    80,665    81,575 

 

 

 - 5 - 

 

Align Technology Announces Second Quarter 2019 Results

 

ALIGN TECHNOLOGY, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

         

   June 30,
2019
  December 31,
2018
ASSETS          
           
Current assets:          
Cash and cash equivalents  $423,500   $636,899 
Marketable securities, short-term   297,422    98,460 
Accounts receivable, net   520,094    439,009 
Inventories   81,124    55,641 
Prepaid expenses and other current assets   135,234    72,470 
Total current assets   1,457,374    1,302,479 
           
Marketable securities, long-term   44,969    9,112 
Property, plant and equipment, net   599,611    521,329 
Operating lease right-of-use assets   57,269     
Equity method investments       45,913 
Goodwill and intangible assets, net   78,852    81,949 
Deferred tax assets   59,050    64,689 
Other assets   48,892    26,987 
           
Total assets  $2,346,017   $2,052,458 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
           
Current liabilities:          
Accounts payable  $61,950   $64,256 
Accrued liabilities   245,634    234,679 
Deferred revenues   481,462    393,138 
Total current liabilities   789,046    692,073 
           
Income tax payable   98,182    78,008 
Operating lease liabilities   59,140     
Other long-term liabilities   25,967    29,486 
Total liabilities   972,335    799,567 
           
Total stockholders' equity   1,373,682    1,252,891 
           
Total liabilities and stockholders' equity  $2,346,017   $2,052,458 

 

 - 6 - 

 

Align Technology Announces Second Quarter 2019 Results

 

ALIGN TECHNOLOGY, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

         

 

   Six Months Ended
June 30,
   2019  2018
       
CASH FLOWS FROM OPERATING ACTIVITIES          
Net cash provided by operating activities  $294,561   $217,121 
           
CASH FLOWS FROM INVESTING ACTIVITIES          
Net cash (used in) provided by investing activities   (321,020)   54,003 
           
CASH FLOWS FROM FINANCING ACTIVITIES          
Net cash used in financing activities   (188,381)   (170,745)
Effect of foreign exchange rate changes on cash, cash equivalents, and restricted cash   1,467    (1,923)
Net (decrease) increase in cash, cash equivalents, and restricted cash   (213,373)   98,456 
Cash, cash equivalents, and restricted cash at beginning of the period   637,566    450,125 
Cash, cash equivalents, and restricted cash at end of the period  $424,193   $548,581 

 

 

 

 

 

 

 

 

 - 7 - 

 

Align Technology Announces Second Quarter 2019 Results

 

ALIGN TECHNOLOGY, INC.

INVISALIGN BUSINESS METRICS*

                                     

 

   Q1  Q2  Q3  Q4  Fiscal  Q1  Q2
   2018  2018  2018  2018  2018  2019  2019
Invisalign Average Selling Price (ASP):                 
Worldwide ASP  $1,310   $1,315   $1,230   $1,235   $1,270   $1,245   $1,230 
International ASP  $1,435   $1,425   $1,340   $1,295   $1,370   $1,330   $1,305 
                                    
Invisalign Cases Shipped by Geography:                               
Americas   166,665    181,425    190,615    189,410    728,115    202,935    211,360 
International   105,570    121,260    128,730    144,390    499,950    146,260    165,785 
Total Cases Shipped   272,235    302,685    319,345    333,800    1,228,065    349,195    377,145 
YoY % growth   30.8%   30.5%   35.3%   30.9%   31.9%   28.3%   24.6%
QoQ % growth   6.7%   11.2%   5.5%   4.5%        4.6%   8.0%
                                    
Number of Invisalign Doctors Cases Were Shipped To:                   
Americas   27,105    28,280    28,890    29,215    42,000    30,200    31,445 
International   19,700    21,805    23,270    25,475    36,040    26,510    28,970 
Total Doctors Cases Shipped To   46,805    50,085    52,160    54,690    78,040    56,710    60,415 
                                    
Invisalign Doctor Utilization Rates**:                               
North America   6.3    6.6    6.9    6.7    18.2    7.0    7.0 
North American Orthodontists   15.3    16.4    17.4    16.5    56.7    18.3    18.9 
North American GP Dentists   3.4    3.6    3.5    3.6    9.1    3.6    3.6 
International   5.4    5.6    5.5    5.7    13.9    5.5    5.7 
Total Utilization Rates   5.8    6.0    6.1    6.1    15.7    6.2    6.2 
                                    
Number of Invisalign Doctors Trained***:                           
Americas   1,630    1,880    2,085    2,290    7,885    1,725    2,890 
International   2,645    3,300    2,845    2,980    11,770    2,410    3,520 
Total Doctors Trained Worldwide   4,275    5,180    4,930    5,270    19,655    4,135    6,410 
Total to Date Worldwide   136,575    141,755    146,685    151,955    151,955    156,090    162,500 

 

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 adjusted to reflect Americas doctors trained for Invisalign iGo 

 

 

 

ALIGN TECHNOLOGY, INC.

STOCK-BASED COMPENSATION

(in thousands)

                                   

   Q1  Q2  Q3  Q4  Fiscal  Q1  Q2
   2018  2018  2018  2018  2018  2019  2019
Stock-based Compensation (SBC)                                   
SBC included in Gross Profit  $881   $900   $966   $948   $3,695   $1,112   $1,278 
SBC included in Operating Expenses   14,949    15,990    18,232    17,897    67,068    19,932    21,189 
Total SBC Expense  $15,830   $16,890   $19,198   $18,845   $70,763   $21,044   $22,467 

 

 

 - 8 - 

 

Align Technology Announces Second Quarter 2019 Results

 

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.

 

 

Financial Outlook

(in millions, except per share amounts and percentages)

       

    Q3'19 Guidance  
       
    GAAP   
       
Net Revenues   $585M - $600M  
       
Gross Margin   71.9% - 72.5%  
       
Operating Expenses   $305M - $312M  
       
Operating Margin   19.8% - 20.5%  
       
Net Income per Diluted Share   $1.09 - $1.16  
       
       
Business Metrics:   Q3'19  
       
Case Shipments   370K - 380K  
Capital Expenditure   $50M-$55M  
Depreciation & Amortization   $24M-$26M  
Diluted Shares Outstanding   80.6M (1)
Stock Based Compensation Expense   $25.0M  
Effective Tax Rate   ~24% (2)

 

(1) Excludes any stock repurchases during the quarter

(2) Includes excess tax benefits related to share-based compensation expense pursuant to ASU 2016-09

 

 

- 9 -

 

 

 

 

 

 

 


The following information was filed by Align Technology Inc (ALGN) on Wednesday, July 24, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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