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8-K - ALIGN TECHNOLOGY, INC. 8-K - ALIGN TECHNOLOGY INCalign8k.htm
EX-99.2 - EXHIBIT 99.2 - ALIGN TECHNOLOGY INCexh99_2.htm
 


Exhibit 99.1
 
Logo
 

 
Align Technology Announces First Quarter Fiscal 2014 Results
 
SAN JOSE, CA--(Marketwired - Apr 23, 2014) - Align Technology, Inc. (NASDAQ: ALGN)
 
 
·
Q1 Net revenues of $180.6 million increased 17.6% year-over-year
 
·
Q1 Invisalign clear aligner net revenues of $168.2 million increased 18.8% year-over-year
 
·
Q1 GAAP earnings per diluted share (EPS) of $0.39
 
·
Board of directors approves $300 million stock repurchase plan
 
Align Technology, Inc. (NASDAQ: ALGN) today reported financial results for the first quarter ended March 31, 2014. Total net revenues for the first quarter of 2014 (Q1'14) were a record $180.6 million, a 17.6% increase year-over-year. Clear aligner case shipments in Q1'14 were 112.2 thousand, a 14.3% increase year-over-year. GAAP net profit for Q1'14 was $32.4 million, or $0.39 per diluted share, an increase of 52.7% year-over-year or $0.13 per diluted share when compared to non-GAAP net profit.
 
"We're pleased with our overall first quarter results with better than expected revenue and earnings," said Thomas M. Prescott, Align president and CEO. "Record first quarter revenue increased nearly 18% year-over-year, driven by strong Invisalign volume. This solid growth reflects continued expansion of our customer base, as well as increased adoption and utilization, as doctors treat more patients with Invisalign. Despite numerous global economic challenges, our business remains strong, with growth driven by continued progress in the EMEA and Asia Pacific regions."
 
Summary Financial Comparisons
(In millions except for shipments and per share amounts)
   
Q1'14
 
Q4'13
 
Q1'13
     
Q/Q
   
Y/Y
 
GAAP
                                     
  Clear Aligner Shipments
   
112,180
   
111,130
   
98,175
       
+0.9
%
   
+14.3
%
  Net Revenues
 
$
180.6
 
$
178.3
 
$
153.6
       
+1.3
%
   
+17.6
%
    Clear Aligner
 
$
168.2
 
$
166.2
 
$
141.6
 
1
   
+1.2
%
   
+18.8
%
    Scanner and Services
 
$
12.4
 
$
12.1
 
$
12.0
 
2
   
+2.8
%
   
+3.3
%
  Net Profit (Loss)
 
$
32.4
 
$
42.2
 
$
(42.0
)
3
   
-23.5
%
   
+177.3
%
  Earnings (Loss) Per Share
 
$
0.39
 
$
0.51
 
$
(0.52
)
3
 
$
(0.12
)
 
$
0.91
 
Non-GAAP
                                     
  Net Profit
 
$
32.4
 
$
42.2
 
$
21.2
       
-23.5
%
   
+52.7
%
  Earnings Per Share
 
$
0.39
 
$
0.51
 
$
0.26
     
$
(0.12
)
   
+$0.13
 
 
Notes:
 
1.
Q1'13 clear aligner net revenues include $4.4 million from the consolidation of Vivera Retainer product shipments from four shipments per year down to one shipment per year, as well as a $2.7 million decrease in net revenues due to the change in the mid-course correction policy which took effect on June 15, 2013.
2.
Q1'13 scanner and services net revenues includes $1.4 million that was deferred in Q3'12 and Q4'12 for an iTero scanner upgrade program which was launched in Q1'13.
3.
Net loss for Q1'13 includes a goodwill impairment charge of $40.7 million and an impairment of long-lived assets of $26.3 million.
 
 
 

 
 
As of March 31, 2014, the Company had $505.4 million in cash, cash equivalents and short-term and long-term marketable securities compared to $472.0 million as of December 31, 2013.
 
Q2 Fiscal 2014 Business Outlook
 
For the second quarter of 2014 (Q2'14), Align provides the following guidance:
 
 
·
Clear aligner case shipments in a range of 116.5 to 119.5 thousand cases.
 
·
Net revenues in a range of $181.7 million to $186.5 million, which reflects a year-over-year increase of 10.9% to 13.8%.
 
·
EPS in a range of $0.36 to $0.39.
 
Stock Repurchase Plan
In a separate announcement today, Align also announced that its board of directors has authorized a plan to repurchase up to $300 million of the Company's stock over the next three years, with $100 million of that amount authorized and anticipated to be purchased over the next twelve months. The plan is effective immediately. Any purchases under Align's stock repurchase program may be made, from time-to-time, pursuant to S.E.C. 10b5-1 plans, open market purchases, accelerated stock repurchases, privately-negotiated transactions, block trades or derivative contracts or otherwise in accordance with applicable federal securities laws, including Rule 10b-18 of the Securities Exchange Act of 1934. For more information, please see Align's press release titled, "Align Technology Announces $300 Million Stock Repurchase Program."
 
Align Web Cast and Conference Call
Align Technology will host a conference call today, April 23, 2014 at 4:30 p.m. ET, 1:30 p.m. PT, to review its first quarter 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 Technology'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 13579429 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 April 30, 2014.
 
Align Technology Analyst Meeting
Align will host an analyst meeting on Thursday, May 29, 2014, from 7:30 - 1:15 p.m. in New York City.
 
Preliminary Analyst Meeting Schedule (subject to change):
7:00 a.m. Onsite registration
7:30 a.m. -- 8:30 a.m. Management hosted breakfast
8:30 a.m. -- 1:15 p.m. Meeting
 
Location:
W Union Square
201 Park Avenue South
New York, NY 10003
Phone: 917-534-5805
 
Registration and Additional Information:
Advanced registration is required for onsite attendance. To register, please use the following link: http://investor.aligntech.com/registration.cfm, or go to our website at http://investor.aligntech.com/ and click on Analyst Meeting 2014.
 
Align will host a live audio web cast of its analyst meeting via the Internet at http://investor.aligntech.com/. An audio replay of the meeting will also be available via web cast for approximately three months following the meeting at http://investor.aligntech.com/.
 
 
 

 
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. The Company also offers the iTero 3D digital scanning system and services for orthodontic and restorative dentistry. Align Technology was founded in March 1997 and received FDA clearance to market Invisalign in 1998. Visit www.aligntech.com for more information.
 
For additional information about Invisalign or to find an Invisalign provider in your area, please visit www.invisalign.com. For additional information about iTero, please visit www.itero.com.
 
About Non-GAAP Financial Measures
To supplement our consolidated financial statements and our business outlook, we may use from time to time the following non-GAAP financial measures: non-GAAP net profit and non-GAAP earnings per share, which exclude, as applicable, impairment of goodwill, impairment of long-lived assets, acquisition and integration related costs, severance and benefit costs 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.
 
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, 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 our 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 quarter and year 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" and "Business Outlook Summary" 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 second quarter of 2014, including, but not limited to, anticipated net revenues, gross margin, operating expenses, operating profit, diluted earnings per share, case shipments and cash, cash equivalents and short-term and long-term investments. 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 fiscal 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
 
   
March 31,
2014
   
March 31,
2013
 
             
Net revenues
  $ 180,646     $ 153,580  
                 
Cost of revenues
    43,395       40,731  
                 
Gross profit
    137,251       112,849  
                 
Operating expenses:
               
Sales and marketing
    52,888       42,281  
General and administrative
    29,179       30,348  
Research and development
    13,380       11,282  
Impairment of goodwill
    -       40,693  
Impairment of long-lived assets
    -       26,320  
Total operating expenses
    95,447       150,924  
                 
Operating profit (loss)
    41,804       (38,075 )
                 
Interest and other income (expense), net
    601       (988 )
                 
Profit (loss) before income taxes
    42,405       (39,063 )
                 
Provision for income taxes
    9,961       2,920  
                 
Net profit (loss)
  $ 32,444     $ (41,983 )
                 
Net profit (loss) per share
               
- basic
  $ 0.40     $ (0.52 )
- diluted
  $ 0.39     $ (0.52 )
                 
Shares used in computing net profit (loss) per share
               
- basic
    81,120       81,248  
- diluted
    82,817       81,248  
   
 
 
 
 

 
ALIGN TECHNOLOGY, INC.
 
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
 
(in thousands)
 
   
   
March 31,
2014
   
December 31,
2013
 
ASSETS
           
             
Current assets:
           
Cash and cash equivalents
  $ 182,766     $ 242,953  
Marketable securities, short-term
    181,674       127,040  
Accounts receivable, net
    126,183       113,250  
Inventories
    15,840       13,968  
Prepaid expenses and other current assets
    43,711       47,465  
Total current assets
    550,174       544,676  
                 
Marketable securities, long-term
    140,932       101,978  
Property, plant and equipment, net
    79,093       75,743  
Goodwill and intangible assets, net
    84,388       85,362  
Deferred tax assets
    22,739       15,766  
Other assets
    8,315       8,622  
                 
Total assets
  $ 885,641     $ 832,147  
 
LIABILITIES AND STOCKHOLDERS' EQUITY
           
             
Current liabilities:
           
Accounts payable
  $ 18,506     $ 17,718  
Accrued liabilities
    71,349       80,345  
Deferred revenues
    81,000       77,275  
Total current liabilities
    170,855       175,338  
                 
Other long term liabilities
    18,033       22,839  
                 
Total liabilities
    188,888       198,177  
                 
Total stockholders' equity
    696,753       633,970  
                 
Total liabilities and stockholders' equity
  $ 885,641     $ 832,147  

 
 

 
ALIGN TECHNOLOGY, INC.
                 
RECONCILIATION OF GAAP TO NON-GAAP KEY FINANCIAL METRICS
                 
                   
Reconciliation of GAAP to Non-GAAP Net Profit
 
Three Months Ended
 
(in thousands, except per share amounts)
 
March 31, 2014
   
December 31, 2013
   
March 31, 2013
 
                   
GAAP Net profit (loss)
  $ 32,444     $ 42,422     $ (41,983 )
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
  $ 32,444     $ 42,422     $ 21,242  
                         
Diluted Net profit (loss) per share:
                       
GAAP
  $ 0.39     $ 0.51     $ (0.52 )
Non-GAAP
  $ 0.39     $ 0.51     $ 0.26  
                         
Shares used in computing diluted GAAP Net profit (loss) per share
    82,817       82,438       81,248  
Shares used in computing diluted Non-GAAP Net profit per share
    82,817       82,438       83,003  
 
 
Notes:
 
(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.
                                 
Q1 2014 FINANCIAL AND BUSINESS METRICS
                             
(in thousands except utilization and doctors trained)
                             
                                   
   
Q1
   
Q2
   
Q3
 
Q4
   
FISCAL
   
Q1
 
   
2013
   
2013
   
2013
 
2013
   
2013
   
2014
 
Invisalign Clear Aligner Net Revenues by Geography:
                                             
 
North America
 
$
97,045
   
$
102,217
   
$
103,888
 
$
105,059
   
$
408,209
   
$
107,910
 
 
International
   
31,818
     
40,320
     
38,983
   
50,595
     
161,716
     
49,848
 
 
Non-case*
   
12,709
     
10,766
     
10,679
   
10,570
     
44,724
     
10,481
 
   
Total Clear Aligner Net Revenues
 
$
141,572
   
$
153,303
   
$
153,550
 
$
166,224
   
$
614,649
   
$
168,239
 
     
YoY % growth
   
14.8
%
   
14.7
%
   
21.2
%
 
25.1
%
   
19.0
%
   
18.8
%
     
QoQ % growth
   
6.6
%
   
8.3
%
   
0.2
%
 
8.3
%
           
1.2
%
 
*includes Invisalign training, ancillary products, and retainers
                                             
Invisalign Clear Aligner Net Revenues by Product:
                                             
 
Invisalign Full Products
 
$
112,780
   
$
123,379
   
$
125,169
 
$
136,179
   
$
497,507
   
$
138,133
 
 
Invisalign Express Products
   
16,083
     
19,158
     
17,702
   
19,475
     
72,418
     
19,625
 
 
Non-case*
   
12,709
     
10,766
     
10,679
   
10,570
     
44,724
     
10,481
 
   
Total Clear Aligner Net Revenues
 
$
141,572
   
$
153,303
   
$
153,550
 
$
166,224
   
$
614,649
   
$
168,239
 
                                               
Average Invisalign Selling Price (ASP):
                                             
 
Worldwide ASP (1)
 
$
1,315
   
$
1,345
   
$
1,335
 
$
1,400
   
$
1,350
   
$
1,405
 
 
Worldwide ASP, adjusted (2)
 
$
1,340
   
$
1,355
   
$
1,335
 
$
1,400
   
$
1,360
   
$
1,405
 
 
International ASP
 
$
1,355
   
$
1,480
   
$
1,455
 
$
1,630
   
$
1,490
   
$
1,620
 
 
(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
   
74,730
     
78,865
     
80,130
   
80,120
     
313,845
     
81,420
 
 
International
   
23,445
     
27,270
     
26,770
   
31,010
     
108,495
     
30,760
 
   
Total Cases Shipped
   
98,175
     
106,135
     
106,900
   
111,130
     
422,340
     
112,180
 
                                               
Invisalign Clear Aligner Cases Shipped by Product:
                                             
 
Invisalign Full Products
   
79,235
     
84,850
     
87,670
   
91,605
     
343,360
     
92,335
 
 
Invisalign Express Products
   
18,940
     
21,285
     
19,230
   
19,525
     
78,980
     
19,845
 
   
Total Cases Shipped
   
98,175
     
106,135
     
106,900
   
111,130
     
422,340
     
112,180
 
                                               
Number of Invisalign Doctors Cases Shipped To:
                                             
 
North America
   
17,280
     
18,070
     
18,140
   
18,495
     
27,330
     
19,015
 
 
International
   
5,840
     
6,355
     
6,510
   
6,925
     
10,800
     
7,185
 
   
Total Doctors Cases Shipped To
   
23,120
     
24,425
     
24,650
   
25,420
     
38,130
     
26,200
 
                                               
Invisalign Doctor Utilization Rates*:
                                             
 
North America
   
4.3
     
4.4
     
4.4
   
4.3
     
11.5
     
4.3
 
 
North American Orthodontists
   
8.0
     
8.0
     
8.4
   
8.0
     
26.4
     
8.1
 
 
North American GP Dentists
   
2.9
     
3.0
     
2.9
   
3.0
     
7.3
     
2.9
 
 
International
   
4.0
     
4.3
     
4.1
   
4.5
     
10.0
     
4.3
 
   
Total Utilization Rates
   
4.3
     
4.4
     
4.3
   
4.4
     
11.1
     
4.3
 
 
* # of cases shipped/# of doctors to whom cases were shipped
                                             
Number of Invisalign Doctors Trained:
                                             
 
North America
   
755
     
1,130
     
795
   
1,460
     
4,140
     
630
 
 
International
   
970
     
1,020
     
875
   
1,060
     
3,925
     
1255
 
   
Total Doctors Trained Worldwide
   
1,725
     
2,150
     
1,670
   
2,520
     
8,065
     
1,885
 
   
Total to Date Worldwide
   
78,220
     
80,370
     
82,040
   
84,560
     
84,560
     
86,445
 
                                               
Scanner and Services Net Revenues:
                                             
 
North America Scanner and Services
 
$
11,952
   
$
10,454
   
$
10,875
 
$
11,980
   
$
45,261
   
$
12,313
 
 
International Scanner and Services
   
56
     
71
     
81
   
88
     
296
     
94
 
   
Total Scanner and Net Revenues
 
$
12,008
   
$
10,525
   
$
10,956
 
$
12,068
   
$
45,557
   
$
12,407
 
                                               
Total Net Revenues by Geography:
                                             
 
Total North America Net Revenues
 
$
108,997
   
$
112,671
   
$
114,763
 
$
117,039
   
$
453,470
   
$
120,223
 
 
Total International Net Revenues
   
31,874
     
40,391
     
39,064
   
50,683
     
162,012
     
49,942
 
 
Total Non-case Net Revenues
   
12,709
     
10,766
     
10,679
   
10,570
     
44,724
     
10,481
 
   
Total Worldwide Net Revenues
 
$
153,580
   
$
163,828
   
$
164,506
 
$
178,292
   
$
660,206
   
$
180,646
 
     
YoY % growth
   
13.7
%
   
12.5
%
   
20.5
%
 
24.8
%
   
17.9
%
   
17.6
%
     
QoQ % growth
   
7.5
%
   
6.7
%
   
0.4
%
 
8.4
%
           
1.3
%
                                               
Stock-based Compensation (SBC)
                                             
 
SBC included in Gross Profit
 
$
600
   
$
600
   
$
700
 
$
700
   
$
2,600
   
$
800
 
 
SBC included in Operating Expenses
   
5,800
     
6,700
     
6,900
   
4,500
     
23,900
     
8,300
 
   
Total SBC Expense
 
$
6,400
   
$
7,300
   
$
7,600
 
$
5,200
   
$
26,500
   
$
9,100
 
                                               
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)
 
   
 
Q2'14 Guidance
   
 
GAAP
   
Net Revenues
$181.7 - $186.5
   
Gross Margin
74.6% - 75.2%
   
Operating Expenses
$96.8 - $98.7
   
Operating Margin
21.3% - 22.4%
   
Net Income per Diluted Share
$0.36 - $0.39*
 
 
Business Metrics:
Q2'14
   
Case Shipments
116.5K - 119.5K
Cash, Cash Equivalents, and Marketable Securities
$545M - $555M*
Capital Expenditure
$13.0M - $15.0M
Depreciation & Amortization
$4.3M - $4.8M
Diluted Shares Outstanding
83.6M*
Stock Based Compensation Expense
$10.8M
Tax Rate
23.0%
   
* Excludes any stock repurchases during the quarter
 
 
 
 
 
Investor Relations Contact
Shirley Stacy
Align Technology, Inc.
(408) 470-1150
sstacy@aligntech.com
 
Press Contact
Shannon Mangum Henderson
Ethos Communication, Inc.
(678) 261-7803
align@ethoscommunication.com