SOURCE: Align Technology

Align Technology

January 29, 2015 16:00 ET

Align Technology Announces Fourth Quarter and 2014 Results

Q4 Revenues of $198.6 Million, up 11.4% Year-Over-Year, and Diluted EPS of $0.48

Q4 Clear Aligner Shipments of 126.9 Thousand Cases, up 14.2% Year-Over-Year

Q4 International Clear Aligner Case Shipments Total 32% of Worldwide Case Shipments, up 29.2% Year-Over-Year

2014 Revenues of $761.7 Million, up 15.4% Year-Over-Year, and Diluted EPS of $1.77

SAN JOSE, CA--(Marketwired - Jan 29, 2015) - Align Technology, Inc. (NASDAQ: ALGN) today reported financial results for the fourth quarter and year ended December 31, 2014. Revenues for the fourth quarter of 2014 (Q4'14) were $198.6 million, an 11.4% increase year-over-year from $178.3 million in the fourth quarter of 2013 (Q4'13). Clear aligner case shipments in Q4'14 were 126.9 thousand, a 14.2% increase year-over-year from 111.1 thousand in Q4'13. Net profit for Q4'14 was $39.5 million, or $0.48 per diluted share, compared to $42.4 million, or $0.51 per diluted share in Q4'13.

Revenues for 2014 were $761.7 million, a 15.4% increase year-over-year from $660.2 million in 2013. Clear aligner case shipments in 2014 were 478.0 thousand, a 13.2% increase year-over-year from 422.3 thousand in 2013. Net profit for 2014 was $145.8 million, or $1.77 per diluted share, compared to non-GAAP net profit of $127.5 million, or $1.54 per diluted share in 2013.

"We are pleased to have delivered a good quarter and finish to the year for Align, driven by continued strong growth in the EMEA and Asia Pacific regions along with solid results in North America," said Thomas M. Prescott, Align president and CEO. "Total International Invisalign volume for the fourth quarter was over 30% of our business for the first time ever, reflecting an increase of 29.2% year-over-year. Our strong performance internationally was driven by a combination of increased utilization by orthodontists in all countries, as well as a continued effort to add new Invisalign-trained doctors."

Summary Financial Comparisons
(In millions except for shipments and per share amounts)

    Q4'14   Q3'14   Q4'13   Q/Q   Y/Y     2014   2013   YTD Y/Y  
GAAP                                                
Clear Aligner Shipments     126,905     119,615     111,130   +6.1 %   +14.2 %     478,000     422,340   +13.2 %
Net Revenues   $ 198.6   $ 189.9   $ 178.3   +4.6 %   +11.4 %   $ 761.7   $ 660.2   +15.4 %
  Clear Aligner   $ 186.4   $ 178.1   $ 166.2   +4.7 %   +12.2 %   $ 712.5   $ 614.6   +15.9 %
  Scanner & Services   $ 12.2   $ 11.7   $ 12.1   +3.6 %   +0.8 %   $ 49.1   $ 45.6   +7.8 %
Net Profit   $ 39.5   $ 38.2   $ 42.4   +3.4 %   (6.8 )%   $ 145.8   $ 64.3   +126.8 %
EPS   $ 0.48   $ 0.47   $ 0.51   +$0.01   $ (0.03 )   $ 1.77   $ 0.78   +$0.99  
Non-GAAP                                                
Net Profit                                 $ 145.8   $ 127.5   +14.4 %
EPS                                 $ 1.77   $ 1.54   +$0.23  

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

As of December 31, 2014, Align had $602.6 million in cash, cash equivalents and short-term and long-term marketable securities compared to $472.0 million as of December 31, 2013. We repurchased approximately 0.4 million shares of stock for $20.8 million in Q4'14 and 1.9 million shares for $98.2 million in 2014. These repurchases are part of a three-year, $300 million stock repurchase program announced on April 23, 2014, with the next $100 million recently authorized by the Board and anticipated to be purchased over the next twelve months.

2014 Business Highlights
The following list highlights Align's key announcements over the past year:

  • Align announced the upcoming release of Invisalign G6 clinical innovations for first premolar extraction. Invisalign G6 is engineered to improve clinical outcomes for orthodontic treatment of severe crowding and bimaxillary protrusion, a common type of malocclusion especially prevalent in Asia that requires premolar extraction. Invisalign G6 clinical innovations will be available to Invisalign-trained providers beginning in the first quarter of 2015 with limited commercialization, followed by full commercialization in Asia Pacific, Europe, Middle East and Africa, and Latin America geographies throughout 2015 and North America in early 2016.
  • Align announced that it has extended its funding of the Align Research Award Program, an annually funded program designed to promote clinical and scientific dental research, for a sixth consecutive year for universities in North America and for a fifth year for international universities.
  • Align expanded chairside CAD/CAM workflow options for the iTero® intraoral scanner by announcing connectivity to IOS Technologies Inc., a wholly owned subsidiary of Glidewell Laboratories.
  • Align expanded digital workflow options for the iTero intraoral scanner by announcing availability of DENTSPLY Implants digital workflow that features connectivity with ATLANTIS™ custom abutments.
  • Align announced an agreement with Zimmer Dental, Inc. in which the iTero intraoral scanner will support connectivity with Zimmer Zfx custom abutments for implants.
  • Align announced new iTero 5.2 software upgrades and feature enhancements for its iTero intraoral scanner. These enhancements reduce total Invisalign scan time, and a new Vivera® pre-debonding feature that allows for digital removal of traditional brackets within the iTero scan, enabling Vivera Retainer delivery at the final orthodontic appointment.
  • Align announced the release of ClinCheck Pro treatment software, the next generation Invisalign treatment software tool, designed to provide more precise control over final tooth position and to help Invisalign providers achieve their treatment goals.
  • Align announced the qualification the 3M™ True Definition scanner for use with Invisalign® case submissions, which requires an intraoral scanner that can readily capture an accurate full arch digital impression.

Q1 2015 Business Outlook
For the first quarter of 2015 (Q1'15), Align provides the following guidance:

  • Clear aligner case shipments in a range of 124.4 thousand to 127.4 thousand.
  • Net revenues in a range of $187.3 million to $192.4 million.
  • Diluted EPS in a range of $0.29 to $0.32.

Align Web Cast and Conference Call
Align will host a conference call today, January 29, 2015 at 4:30 p.m. ET, 1:30 p.m. PT, to review its fourth quarter and 2014 results, discuss future operating trends and the business outlook. The conference call will also be web cast live via the Internet. To access the web cast, 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 approximately fifteen minutes prior to the start of the call. 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 13598471 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 5, 2015.

About Align Technology, Inc.
Align Technology is the leader in modern clear aligner orthodontics that designs, manufactures and markets the Invisalign® system, which provides dental professionals with a range of treatment options for adults and teenagers. Align also offers the iTero 3D digital scanning system and services for orthodontic and restorative dentistry. Align was founded in March 1997 and received FDA clearance to market the Invisalign system in 1998. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign provider in your area, please visit www.invisalign.com. For additional information about the iTero 3D digital scanning system, please visit www.itero.com.

About Non-GAAP Financial Measures
While there are no non-GAAP adjustments to the three months and full year ended December 31, 2014, we are including the following non-GAAP financial measures for the year ended December 31, 2013 to supplement our consolidated financial statements: non-GAAP net profit and non-GAAP earnings per share, which exclude, as applicable, impairment of goodwill, impairment of long-lived assets, and any related income tax adjustments. 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.

Align uses 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, on-going and customary course of its operations. Accordingly, management excludes from "core operating performance" certain expenditures and other items that may not be indicative of our operating performance including discrete cash and non-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 institutional investors and the analyst community to facilitate comparisons with prior and subsequent reporting periods. A reconciliation of the GAAP and non-GAAP financial measures for the nine months ended September 30, 2013 and a more detailed explanation of each non-GAAP financial measure and its uses are provided in the footnotes to the table captioned "Reconciliation of GAAP to non-GAAP Key Financial Metrics" included at the end of this release.

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 2015, including, but not limited to, anticipated net revenues, gross margin, operating expenses, operating profit, diluted earnings per share, case shipments, and additional common stock repurchases. 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, 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, 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 capacity constraints and pressure on our internal systems and personnel, our ability to successfully achieve the anticipated benefits from the scanner and services business, 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, 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 protect its intellectual property rights, continued compliance with regulatory requirements, competition from existing and new competitors, 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, 2013, which was filed with the Securities and Exchange Commission on February 28, 2014. 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   Year Ended  
  December 31,
2014
  December 31,
2013
  December 31,
2014
  December 31,
2013
 
                         
Net revenues $ 198,600   $ 178,292   $ 761,653   $ 660,206  
                         
Cost of revenues   47,938     41,816     183,210     162,100  
                         
Gross profit   150,662     136,476     578,443     498,106  
                         
Operating expenses:                        
  Sales and marketing   55,620     44,694     217,262     180,046  
  General and administrative   30,273     27,889     114,806     112,752  
  Research and development   13,276     10,970     52,799     44,083  
  Impairment of goodwill   -     -     -     40,693  
  Impairment of long-lived assets   -     -     -     26,320  
Total operating expenses   99,169     83,553     384,867     403,894  
                         
Operating profit   51,493     52,923     193,576     94,212  
                         
Interest and other income (expense), net   (1,716 )   (199 )   (3,207 )   (1,073 )
                         
Profit before income taxes   49,777     52,724     190,369     93,139  
                         
Provision for income taxes   10,236     10,302     44,537     28,844  
                         
Net profit $ 39,541   $ 42,422   $ 145,832   $ 64,295  
                         
Net profit per share                        
  - basic $ 0.49   $ 0.53   $ 1.81   $ 0.80  
  - diluted $ 0.48   $ 0.51   $ 1.77   $ 0.78  
                         
Shares used in computing net profit per share                        
  - basic   80,266     80,432     80,754     80,551  
  - diluted   81,691     82,438     82,283     82,589  
                         
                         
       
       
ALIGN TECHNOLOGY, INC.      
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS    
(in thousands)      
       
  December 31,
2014
  December 31,
2013
ASSETS          
           
Current assets:          
  Cash and cash equivalents $ 199,871   $ 242,953
  Marketable securities, short-term   254,787     127,040
  Accounts receivable, net   129,751     113,250
  Inventories   15,928     13,968
  Prepaid expenses and other current assets   56,823     47,465
    Total current assets   657,160     544,676
           
Marketable securities, long-term   147,892     101,978
Property, plant and equipment, net   90,125     75,743
Goodwill and intangible assets, net   82,056     85,362
Deferred tax assets   3,099     15,766
Other assets   7,665     8,622
           
    Total assets $ 987,997   $ 832,147
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
           
Current liabilities:          
  Accounts payable $ 23,247   $ 17,718
  Accrued liabilities   87,880     80,345
  Deferred revenues   90,684     77,275
    Total current liabilities   201,811     175,338
           
Other long term liabilities   33,415     22,839
           
    Total liabilities   235,226     198,177
           
Total stockholders' equity   752,771     633,970
           
  Total liabilities and stockholders' equity $ 987,997   $ 832,147
           
           
         
         
ALIGN TECHNOLOGY, INC.        
RECONCILIATION OF GAAP TO NON-GAAP KEY FINANCIAL METRICS        
         
         
Reconciliation of GAAP to Non-GAAP Operating Profit        
(in thousands) Year Ended  
  December 31, 2014   December 31, 2013  
             
GAAP Operating profit $ 193,576   $ 94,212  
  Impairment of goodwill (1)   -     40,693  
  Impairment of long-lived assets (2)   -     26,320  
Non-GAAP Operating profit $ 193,576   $ 161,225  
             
             
             
Reconciliation of GAAP to Non-GAAP Net Profit            
(in thousands, except per share amounts)   Year Ended  
    December 31, 2014     December 31, 2013  
             
GAAP Net profit $ 145,832   $ 64,295  
  Impairment of goodwill (1)   -     40,693  
  Impairment of long-lived assets (2)   -     26,320  
  Income tax-related adjustments (3)   -     (3,788 )
Non-GAAP Net profit $ 145,832   $ 127,520  
             
Diluted Net profit per share:            
  GAAP $ 1.77   $ 0.78  
  Non-GAAP $ 1.77   $ 1.54  
             
Shares used in computing diluted GAAP Net profit (loss) per share   82,283     82,589  
Shares used in computing diluted Non-GAAP Net profit per share   82,283     82,589  
             
             

Notes:
There were no Non-GAAP adjustments for the three months ended December 31, 2014 or 2013.

(1) Impairment of goodwill. These costs represent non-cash write-downs of our goodwill generally related to negative trends in market and economic conditions, termination of relationships with distributors, or the increase in competitive environment related to our Scanner and Services reporting unit. We remove the impact of these charges to our operating performance to assist in assessing our ability to generate cash from operations. We believe this may be useful information to users of our financial statements; therefore, we have excluded these charges for purposes of calculating these non-GAAP measures to facilitate an evaluation of our current operating performance, particularly in terms of liquidity.

(2) Impairment of long-lived assets. These costs represent non-cash write-downs of our long-lived assets generally related to the increase in competitive environment related to our Scanner and Services reporting unit. As a result of these conditions, we have assessed that our asset group within the reporting unit was not recoverable and, therefore, recorded an impairment charge. We remove the impact of these charges to our operating performance to assist in assessing our ability to generate cash from operations. We believe this may be useful information to users of our financial statements; therefore, we have excluded these charges for purposes of calculating these non-GAAP measures to facilitate an evaluation of our current operating performance, particularly in terms of liquidity.

(3) Income tax-related adjustments. Non-GAAP financial information for the quarter is adjusted for a tax rate equal to our annual estimated tax rate on non-GAAP income. This rate is based on our estimated annual GAAP income tax rate forecast, adjusted to account for discrete tax items and items excluded from GAAP income in calculating the non-GAAP financial measures presented above. Our estimated tax rate on non-GAAP income is determined annually and may be re-calculated during the year to take into account events or trends that we believe materially impact the estimated annual rate.

ALIGN TECHNOLOGY, INC.                                          
Q4 2014 FINANCIAL AND BUSINESS METRICS                                          
(in thousands except utilization and doctors trained)                                          
 
 
                             
  Q4   YTD   Q1   Q2   Q3   Q4   YTD  
  2013   2013   2014   2014   2014   2014   2014  
Invisalign Clear Aligner Net Revenues by Geography:                                          
  North America $ 105,059   $ 408,209   $ 107,910   $ 111,648   $ 113,349   $ 113,670   $ 446,577  
  International   50,595     161,716     49,848     55,988     53,439     60,467     219,742  
  Non-case*   10,570     44,724     10,481     12,099     11,350     12,300     46,230  
    Total Clear Aligner Net Revenues $ 166,224   $ 614,649   $ 168,239   $ 179,735   $ 178,138   $ 186,437   $ 712,549  
      YoY % growth   25.1 %   19.0 %   18.8 %   17.2 %   16.0 %   12.2 %   15.9 %
      QoQ % growth   8.3 %         1.2 %   6.8 %   -0.9 %   4.7 %      
  *includes Invisalign training, ancillary products, and retainers                                          
                                           
Invisalign Clear Aligner Net Revenues by Product:                                          
  Invisalign Full Products $ 136,179   $ 497,507   $ 138,133   $ 147,158   $ 147,583   $ 152,847   $ 585,721  
  Invisalign Express Products   19,475     72,418     19,625     20,478     19,205     21,290     80,598  
  Non-case*   10,570     44,724     10,481     12,099     11,350     12,300     46,230  
    Total Clear Aligner Net Revenues $ 166,224   $ 614,649   $ 168,239   $ 179,735   $ 178,138   $ 186,437   $ 712,549  
                                           
Average Invisalign Selling Price (ASP):                                          
  Worldwide ASP (1) $ 1,400   $ 1,350   $ 1,405   $ 1,405   $ 1,395   $ 1,370   $ 1,395  
  Worldwide ASP, adjusted (2) $ 1,400   $ 1,360   $ 1,405   $ 1,405   $ 1,395   $ 1,370   $ 1,395  
  International ASP $ 1,630   $ 1,490   $ 1,620   $ 1,625   $ 1,560   $ 1,510   $ 1,575  
  (1) Invisalign case net revenues / Invisalign case shipments                                          
  (2) Adjusted for one-time adjustments (eg. Q1'13 and Q2'13 grandfathered mid-course correction deferrals)                                          
                                           
Invisalign Clear Aligner Cases Shipped by Geography:                                          
  North America   80,120     313,845     81,420     84,850     85,405     86,855     338,530  
  International   31,010     108,495     30,760     34,450     34,210     40,050     139,470  
    Total Cases Shipped   111,130     422,340     112,180     119,300     119,615     126,905     478,000  
                                           
Invisalign Clear Aligner Cases Shipped by Product:                                          
  Invisalign Full Products   91,605     343,360     92,335     98,565     99,385     104,770     395,055  
  Invisalign Express Products   19,525     78,980     19,845     20,735     20,230     22,135     82,945  
    Total Cases Shipped   111,130     422,340     112,180     119,300     119,615     126,905     478,000  
                                           
Number of Invisalign Doctors Cases Shipped To:                                          
  North America   18,495     27,330     19,015     19,505     19,550     19,745     29,890  
  International   6,925     10,800     7,185     7,685     7,950     8,945     13,450  
    Total Doctors Cases Shipped To   25,420     38,130     26,200     27,190     27,500     28,690     43,340  
                                           
Invisalign Doctor Utilization Rates*:                                          
  North America   4.3     11.5     4.3     4.4     4.4     4.4     11.3  
  North American Orthodontists   8.0     26.4     8.1     8.4     8.8     8.6     27.7  
  North American GP Dentists   3.0     7.3     2.9     2.9     2.8     2.9     6.9  
  International   4.5     10.0     4.3     4.5     4.3     4.5     10.4  
    Total Utilization Rates   4.4     11.1     4.3     4.4     4.4     4.4     11.0  
  * # of cases shipped/# of doctors to whom cases were shipped                                          
                                           
Number of Invisalign Doctors Trained:                                          
  North America   1,460     4,140     700     1,150     1,125     1,170     4,145  
  International   1,060     3,925     1,255     1,380     1,400     1,255     5,290  
    Total Doctors Trained Worldwide   2,520     8,065     1,955     2,530     2,525     2,425     9,435  
    Total to Date Worldwide   84,560     84,560     86,515     89,045     91,570     93,995     93,995  
                                           
Scanner and Services Net Revenues:                                          
  North America Scanner and Services $ 11,980   $ 45,261   $ 12,313   $ 12,698   $ 11,579   $ 12,104   $ 48,694  
  International Scanner and Services   88     296     94     98     159     59     410  
    Total Scanner and Net Revenues $ 12,068   $ 45,557   $ 12,407   $ 12,796   $ 11,738   $ 12,163   $ 49,104  
                                           
Total Net Revenues by Geography:                                          
  Total North America Net Revenues $ 117,039   $ 453,470   $ 120,223   $ 124,346   $ 124,928   $ 125,774   $ 495,271  
  Total International Net Revenues   50,683     162,012     49,942     56,086     53,598     60,526     220,152  
  Total Non-case Net Revenues   10,570     44,724     10,481     12,099     11,350     12,300     46,230  
    Total Worldwide Net Revenues $ 178,292   $ 660,206   $ 180,646   $ 192,531   $ 189,876   $ 198,600   $ 761,653  
      YoY % growth   24.8 %   17.9 %   17.6 %   17.5 %   15.4 %   11.4 %   15.4 %
      QoQ % growth   8.4 %         1.3 %   6.6 %   -1.4 %   4.6 %      
                                           
Stock-based Compensation (SBC)                                          
  SBC included in Gross Profit $ 700   $ 2,600   $ 800   $ 940   $ 865   $ 965   $ 3,570  
  SBC included in Operating Expenses   4,500     23,900     8,300     9,370     9,045     9,510     36,225  
    Total SBC Expense $ 5,200   $ 26,500   $ 9,100   $ 10,310   $ 9,910   $ 10,475   $ 39,795  
                                           
Note: Historical public data may differ due to rounding. Additionally, rounding may effect totals.
 
 
   
   
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)  
   
  Q1'15 Guidance
   
  GAAP
   
Net Revenues $187.3 - $192.4
   
Gross Margin 73.5% - 74.0%
   
Operating Expenses $105.2 - $106.5
   
Operating Margin 17.4% - 18.6%
   
Net Income per Diluted Share $0.29 - $0.32
   
   
Business Metrics: Q1'15
   
Case Shipments 124.4K - 127.4K
Capital Expenditure $20M - $25M
Depreciation & Amortization $4.5M - $5.0M
Diluted Shares Outstanding 82.1M*
Stock Based Compensation Expense $12.5M
Tax Rate 23.0%
   
* Excludes any stock repurchases during the quarter