January 29, 2015

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) -- 01/29/15 -- 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

Source: Align Technology

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