UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported) July 29, 2008

ALIGN TECHNOLOGY, INC.
(Exact Name of Registrant as Specified in Its Charter)
 
Delaware
(State or Other Jurisdiction of Incorporation)
 
0-32259
94-3267295
(Commission File Number)
(IRS Employer Identification No.)
 
881 Martin Avenue, Santa Clara, California
95050
(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)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 
ITEM 2.02 RESULTS OF OPERATIONS AND FINANCIAL CONDITIONS

On July 29, 2008, Align Technology, Inc. ("Align") is issuing a press release and holding a conference call regarding its financial results for its second quarter ended June 30, 2008. 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.

Align is making reference to non-GAAP financial information in both the press release and the conference call. A reconciliation of non-GAAP financial measures contained in the attached press release to the comparable GAAP financial measures is contained in the attached press release and a reconciliation of these and certain other non-GAAP financial information provided on the conference call (to the extent not reconciled on such call) is contained on the Investor Relations section of our website at investor.aligntech.com.
 
ITEM 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.
Description
99.1
Press Release of Align Technology, Inc. dated July 29, 2008



SIGNATURES

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: July 29, 2008
ALIGN TECHNOLOGY, INC.
     
  By:
 /s/Kenneth B. Arola
   
 Kenneth B. Arola
   
 Vice President, Finance and Chief Financial Officer
 


INDEX TO EXHIBITS

Exhibit No.
Description
99.1
Press Release of Align Technology, Inc. dated July 29, 2008
 

Unassociated Document
align
 
Investor Relations Contact
Press Contact
Shirley Stacy
Shannon Mangum Henderson
Align Technology, Inc.
Ethos Communication, Inc.
(408) 470-1150
(678) 540-9222
sstacy@aligntech.com
align@ethoscommunication.com

Align Technology Announces Second Quarter Fiscal 2008 Results

 
·
Record Q2 net revenues of $79.9 million increase 6.9 percent sequentially
 
·
Q2 GAAP net profit of $4.0 million, or $0.06 per diluted share
 
·
Case shipments of 54,870 increase 6.0 percent sequentially
 
·
Initiating cost-saving measures including a workforce reduction

SANTA CLARA, Calif., July 29, 2008 / — Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the second quarter of fiscal 2008, ended June 30, 2008.

Total net revenues for the second quarter of fiscal 2008 (Q2 08) were a record $79.9 million. This reflects a year-over-year increase of 4.3 percent compared to $76.6 million in the second quarter of 2007 (Q2 07). On a sequential basis, net revenues increased 6.9 percent from $74.8 million in the first quarter of 2008 (Q1 08). Q2 07 shipments included approximately four thousand cases and revenue of $5.2 million from the reduction in backlog and cycle times caused by the allocation of capacity to the Patients First Program during the fourth quarter of 2006 and the first quarter of 2007.

“I’m pleased with our solid performance in the second quarter despite an ever more challenging economic environment for our doctors and their patients,” said Thomas M. Prescott, president and CEO of Align Technology. “During the second quarter, we continued to execute on our strategic initiatives including today’s launch of Invisalign Teen following the successful pilot of the product.”

Net profit for Q2 08 was $4.0 million, or $0.06 per diluted share. This is compared to net profit of $13.6 million, or $0.19 per diluted share in Q2 07, and net profit of $5.3 million, or $0.07 per diluted share in Q1 08. Stock-based compensation expense included in Q2 08 net profit was $4.8 million, compared to $2.9 million in Q2 07, and $4.0 million in Q1 08.

The Company also announced measures to reduce operating expenses.
 
Align Technology Inc. 881 Martin Avenue Santa Clara, CA 95050 Tel: (408) 470-1000 Fax: (408) 470-1201
 

 
Align Technology, Inc. Q2 Fiscal 2008 Earnings Release
 
Prescott said, “As consumer spending has continued to soften, so has our outlook for revenue growth. As a result, we’re reducing overall company spending and slowing headcount growth while preserving the important investments in strategic priorities. Unfortunately, valued employees will be affected, and those are decisions that the management team and I do not take lightly. These actions are only the first steps in actively reducing our cost structure and moving towards a financial model with greater operating leverage.”

The cost-saving measures include: a reduction in full time headcount of 38, slowing headcount growth for the remainder of 2008, and cuts in discretionary spending. These actions will reduce expenses in the second half of 2008 by approximately $5 million to $6 million. In addition, the company is implementing a phased consolidation of its order acquisition operations in Santa Clara, California into its existing operations in Juarez, Mexico by the end of 2008. Upon completion, 29 positions in Santa Clara will be eliminated, resulting in annualized cost savings of approximately $1.0 to $1.5 million in 2009. As part of these actions, Align will record a restructuring charge estimated to be approximately $2.6 million in the second half of fiscal 2008, of which approximately $2.2 million will be realized in Q3 08. At the end of Q2 08, Align had a regular employee base of approximately 1,400 worldwide.
 
Q2 08 Operating Results

Key GAAP Operating Results
 
Q2 08
 
Q1 08
 
Q2 07
 
Gross Margin
   
74.7
 
73.8
 
73.6
%
Operating Expense
 
$
55.8M
 
$
50.5M
 
$
42.9M
 
Operating Margin
   
4.8
%
 
6.2
%
 
17.6
%
Net Profit
 
$
4.0M
 
$
5.3M
 
$
13.6M
 
Earnings Per Diluted Share (EPS)
 
$
0.06
 
$
0.07
 
$
0.19
 

Liquidity and Capital Resources

As of June 30, 2008, Align had $110.1 million in cash, cash equivalents, and short term marketable securities compared to $127.9 million as of December 31, 2007. During Q2 08, Align purchased 2.2 million shares at an average price of $12.65 per share for a total of $27.7 million. There remains $22.3 million under the Company’s existing stock repurchase authorization.
 
Key Business Metrics

The following table highlights business metrics for Align’s second quarter of 2008. Additional historical information is available on the Company’s website at http://investor.aligntech.com.

Revenue by Channel:
 
Q2 08
 
Q2’08/Q1’08
% Change
 
Q2’08/Q2’07
% Change (a)
 
U.S. Orthodontists
 
$
23.3M
   
2.1
%
 
(6.7
)%
U.S. GP Dentists
 
$
36.6M
   
5.2
%
 
0.6
%
International
 
$
16.4M
   
15.8
%
 
41.3
%
Training and Other
 
$
3.6M
   
20.2
%
 
(1.1
)%
Total Revenue
 
$
79.9M
   
6.9
%
 
4.3
%
 
- 2 -

 
Align Technology, Inc. Q2 Fiscal 2008 Earnings Release
 
Average Selling Price (ASP):
 
Q2 08
 
Q2’08/Q1’08
% Change
 
Q2’08/Q2’07
% Change
 
Total Worldwide Blended ASP
 
$
1,390
   
0.7
%
 
4.5
%
Total Worldwide ASP excluding Invisalign Express
 
$
1,500
   
(0.7
)%
 
4.9
%
U.S. Orthodontists Blended ASP
 
$
1,290
   
(0.8
)%
 
4.9
%
U.S. GP Dentists Blended ASP
 
$
1,340
   
0.0
%
 
2.3
%
International
 
$
1,700
   
0.0
%
 
4.3
%
 
Number of Cases Shipped:
 
Q2 08
 
Q2’08/Q1’08
% Change
 
Q2’08/Q2’07
% Change (a)
 
U.S. Orthodontists – Full Invisalign
   
14,830
   
2.3
%
 
(11.9
)%
U.S. Orthodontists – Invisalign Express
   
3,250
   
5.2
%
 
(3.6
)%
U.S. GP Dentists – Full Invisalign
   
22,140
   
5.9
%
 
(2.7
)%
U.S. GP Dentists – Invisalign Express
   
4,970
   
0.4
%
 
1.2
%
International– Full Invisalign
   
9,520
   
16.1
%
 
35.4
%
International– Invisalign Express
   
160
   
23.1
%
 
45.5
%
Total Cases Shipped
   
54,870
   
6.0
%
 
(0.3
)%
 
Number of Doctors Cases were Shipped to:
   
Q2 08
 
U.S. Orthodontists
   
3,730
 
U.S. GP Dentists
   
11,030
 
International
   
2,910
 
Total Doctors Cases were Shipped to Worldwide
   
17,670
 
 
Number of Doctors Trained Worldwide:
 
Q2 08
 
Cumulative
 
U.S. Orthodontists
   
100
   
8,510
 
U.S. GP Dentists
   
1,630
   
30,260
 
International
   
600
   
13,340
 
Total Doctors Trained Worldwide
   
2,330
   
52,110
 
 
Multiple Case Doctors (Cumulative as of):
 
Q2 08
 
U.S. Orthodontists
   
90.5
%
U.S. GP Dentists
   
86.6
%
International
   
77.2
%
 
Doctors Starting Invisalign Treatment (Cumulative as of):
 
Q2 08
 
U.S. Orthodontists
   
6,920
 
U.S. GP Dentists
   
23,820
 
International
   
7,390
 
Total Doctors Starting Invisalign Treatment
   
38,130
 
 
Doctor Utilization Rates*:
 
Q2 08
 
Q1 08
 
Q2 07(a)
 
U.S. Orthodontists
   
4.9
   
4.8
   
5.3
 
U.S. GP Dentists
   
2.5
   
2.4
   
2.7
 
International
   
3.3
   
3.2
   
3.1
 
Total Utilization Rate
   
3.1
   
3.1
   
3.4
 

* Utilization = # of cases/# of doctors to whom cases were shipped
(a) Q2 07 shipments included approximately four thousand cases and revenue of $5.2 million from the reduction in backlog and cycle times caused by the allocation of capacity to the Patients First Program during the fourth quarter of 2006 and the first quarter of 2007
 
- 3 -

 
Align Technology, Inc. Q2 Fiscal 2008 Earnings Release
 
Business Outlook
 
For the third quarter of fiscal 2008 (Q3 08), Align Technology expects net revenues to be in a range of $74 million to $76 million. GAAP earnings per diluted share for Q3 08 is expected to be in a range of $0.01 to $0.03. Non-GAAP earnings per diluted share for Q3 08 is expected to be in a range of $0.04 to $0.06. Stock-based stock compensation expense for Q3 08 is expected to be approximately $4.7 million.
 
For fiscal 2008, Align Technology expects net revenues to be in a range of $309 million to $314 million. The increase in deferred revenue for fiscal 2008 is expected to be in the range of $5 million to $8 million primarily associated with new products, which will be recognized in future periods, bringing the Company’s total deferred revenue balance at the end of 2008 to a range of $17 million to $20 million. GAAP earnings per diluted share for fiscal 2008 is expected to be in a range of $0.26 to $0.30. Non-GAAP earnings per diluted share for fiscal 2008 is expected to be in a range of $0.29 to $0.33. Stock-based compensation expense for fiscal 2008 is expected to be approximately $17.9 million.
 
A more comprehensive business outlook is available following the financial tables of this release.

Invisalign Teen
 
In a separate announcement today Align also announced a new addition to its Invisalign product family: Invisalign Teen for non-adult, comprehensive orthodontic treatment. For more information, please see Align's press release titled, " Align Technology Targets Mainstream Orthodontics Market with Invisalign Teen."
 
Align Web Cast and Conference Call

Align Technology will host a conference call today, July 29, 2008 at 4:30 p.m. ET, 1:30 p.m. PT, to review its second quarter fiscal 2008 results, discuss future operating trends and 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 201-689-8341 approximately fifteen minutes prior to the start of the call. If you are unable to listen to the call, an archived web cast will be available beginning approximately one hour after the call's conclusion and will remain available for approximately 12 months. Additionally, a telephonic replay of the call can be accessed by dialing 877-660-6853 with account number 292 followed by # and conference number 289687 followed by #. The replay must be accessed from international locations by dialing 201-612-7415 and using the same account and conference numbers referenced above. The telephonic replay will be available through 4:30 p.m. ET on August 12, 2008.
 
About Align Technology, Inc.

Align Technology designs, manufactures and markets Invisalign, a proprietary method for treating malocclusion, or the misalignment of teeth. Invisalign corrects malocclusion using a series of clear, nearly invisible, removable appliances that gently move teeth to a desired final position. Because it does not rely on the use of metal or ceramic brackets and wires, Invisalign significantly reduces the aesthetic and other limitations associated with braces. Invisalign is appropriate for treating adults and older teens. Align Technology was founded in March 1997 and received FDA clearance to market Invisalign in 1998.

To learn more about Invisalign or to find a certified Invisalign doctor in your area, please visit www.invisalign.com or call 1-800-INVISIBLE.
 
- 4 -

Align Technology, Inc. Q2 Fiscal 2008 Earnings Release

About non-GAAP Financial Measures

To supplement our business outlook, we use the following non-GAAP financial measures: non-GAAP operating expenses, net profit (loss), earnings (loss) per share, which excludes the restructuring charge. The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP. For more information on these non-GAAP financial measures, please see the tables captioned “Business Outlook Summary” included at the end of this release.

We use these non-GAAP financial measures for financial and operational decision making and as a means to evaluate period-to-period comparisons. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding our “core operating performance”. Management believes that “core operating performance” represents Align’s performance in the ordinary, ongoing and customary course of its operations. Accordingly, management excludes from “core operating performance” certain expenses and expenditures that may not be indicative of our operating performance including discrete 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.
 
Forward-Looking Statement

This news release, including the tables below, contains forward-looking statements, including statements regarding Align's anticipated amount of cost savings due to the cost-saving measures, the expected amount of and timing of the charges to be incurred in connection with these measures and Align’s anticipated financial results and certain business metrics for the third quarter and full year of 2008, including anticipated revenue and deferred revenue, gross profit, gross margin, operating expense, net profit, earnings per share, percentage of revenue by channel, case shipments and average selling prices. 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, failure to achieve the expected cost savings, including a delay in the implementation of the relocation of order acquisition to Mexico and greater than anticipated costs resulting from the relocation, changes in the size of the expected restructuring charge, 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, continued customer demand for Invisalign and new products, changes in consumer spending habits as a result of, among other tings, 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 Invisalign by consumers and dental professionals, Align's third party manufacturing processes and personnel, foreign operational, political and other risks relating to Align's international manufacturing operations, Align's ability to protect its intellectual property rights, competition from manufacturers of traditional braces and new competitors, Align's ability to develop and successfully introduce new products and product enhancements, and the loss of key personnel. 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, 2007, which was filed with the Securities and Exchange Commission on February 26, 2008. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
 
- 5 -


Align Technology, Inc. Q2 Fiscal 2008 Earnings Release

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
 
 
 
Three Months Ended
 
Six Months Ended
 
 
 
June 30, 2008
 
June 30, 2007
 
June 30, 2008
 
June 30, 2007
 
                           
Net revenues
 
$
79,902
 
$
76,603
 
$
154,678
 
$
140,364
 
                           
Cost of revenues
   
20,243
   
20,247
   
39,851
   
37,776
 
                           
Gross profit
   
59,659
   
56,356
   
114,827
   
102,588
 
                           
Operating expenses:
                         
Sales and marketing
   
32,464
   
24,353
   
60,523
   
47,503
 
General and administrative
   
16,322
   
11,880
   
31,510
   
24,065
 
Research and development
   
7,001
   
6,675
   
14,296
   
12,368
 
Patients First Program
   
-
   
-
   
-
   
(1,796
)
                           
Total operating expenses
   
55,787
   
42,908
   
106,329
   
82,140
 
                           
Profit from operations
   
3,872
   
13,448
   
8,498
   
20,448
 
                           
Interest and other income, net
   
443
   
680
   
1,409
   
1,135
 
                           
Profit before income taxes
   
4,315
   
14,128
   
9,907
   
21,583
 
                           
Provision for income taxes
   
(285
)
 
(510
)
 
(573
)
 
(987
)
                           
Net profit
 
$
4,030
 
$
13,618
 
$
9,334
 
$
20,596
 
                           
Net profit per share
                         
- basic
 
$
0.06
 
$
0.20
 
$
0.14
 
$
0.31
 
- diluted
 
$
0.06
 
$
0.19
 
$
0.13
 
$
0.29
 
                           
Shares used in computing net profit per share
                         
- basic
   
68,581
   
66,696
   
68,817
   
66,068
 
- diluted
   
69,916
   
71,207
   
70,478
   
70,346
 
 
- 6 -


Align Technology, Inc. Q2 Fiscal 2008 Earnings Release
 
ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
 
   
June 30, 2008
 
December 31, 2007
 
ASSETS
             
               
Current assets:
             
Cash and cash equivalents
 
$
64,339
 
$
89,140
 
Marketable securities, short-term
   
45,723
   
38,771
 
Accounts receivable, net
   
51,173
   
44,850
 
Inventories, net
   
3,017
   
2,910
 
Other current assets
   
10,132
   
8,846
 
Total current assets
   
174,384
   
184,517
 
               
Property and equipment, net
   
29,525
   
25,320
 
Goodwill and intangible assets, net
   
9,675
   
11,093
 
Other long-term assets
   
3,585
   
1,831
 
               
Total assets
 
$
217,169
 
$
222,761
 
               
LIABILITIES AND STOCKHOLDERS' EQUITY
             
               
Current liabilities:
             
Accounts payable
 
$
8,965
 
$
9,222
 
Accrued liabilities
   
34,708
   
39,875
 
Deferred revenues
   
14,144
   
12,362
 
Total current liabilities
   
57,817
   
61,459
 
               
Other long term liabilities
   
133
   
148
 
               
Total liabilities
   
57,950
   
61,607
 
               
Total stockholders' equity
   
159,219
   
161,154
 
               
Total liabilities and stockholders' equity
 
$
217,169
 
$
222,761
 
 
- 7 -

 
Align Technology, Inc. Q2 Fiscal 2008 Earnings Release

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. This outlook excludes the effects of any stock repurchases.

Financials (including reconciliation of GAAP to non-GAAP financial measures):
(in millions, except per share amounts and percentages)

 
Q3 2008
 
FY 2008
                       
 
GAAP
 
Adjustment
(a)
Non-GAAP
 
FY 2008
 
Adjustment
(a)
Non-GAAP
                       
Net Revenue
$74.0 - $76.0
     
$74.0 - $76.0
 
$309.0 - $314.0
     
$309.0 - $314.0
                       
Gross Margin
73.6% - 74.4%
     
73.6% - 74.4%
 
73.7% - 74.2%
     
73.7% - 74.2%
                       
Operating Expenses
$53.7 - $55.2
 
$2.2
(a)
$51.5 - $53.0
 
$210.8 - $213.8 
 
$2.6 
(a)
$208.2 - $211.2
                       
Net Profit %
1% - 2%
 
3%
 
4% - 5%
 
6% - 7%
 
1%
 
7% - 8%
                       
Net Profit per Diluted Share
$0.01 - $0.03
 
$0.03 
 
$0.04 - $0.06
 
$0.26 - $0.30
 
$0.03 
 
$0.29 - $0.33
                                                                                                                           
Stock Based Compensation Expense:
                     
Cost of Revenues
$0.4
     
$0.4
 
$1.7
     
$1.7
Operating Expenses
$4.3
     
$4.3
 
$16.2
     
$16.2
Total Stock Based Compensation Expense
$4.7
     
$4.7
 
$17.9
     
$17.9
                       
Increase in Deferred Revenue
           
$5.0 - $8.0
     
$5.0 - $8.0
                       
Total Deferred Revenue Balance
           
$17.0 - $20.0
     
$17.0 - $20.0

(a) Restructuring charges

Business Metrics:
 
   
Q3 2008
 
FY 2008
 
Case Shipments
 
51.0K - 53.0K
 
213.0K - 216.5K
 
Cash
 
$116M - $120M
 
$130M - $135M
 
DSO
 
~57 days
 
~57 days
 
Capex
 
$3.0M - $5.0M
 
$14.0M - $18.0M
 
Depreciation & Amortization
 
$2.0M - $3.0M
 
$13.0M - $14.0M
 
Diluted Shares Outstanding
 
70.0M
 
70.0M
 
 
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