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Align Technology Announces Third Quarter 2018 Financial Results

October 24, 2018 4:08 PM

SAN JOSE, Calif., Oct. 24, 2018 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the third quarter ended September 30, 2018. Invisalign case shipments in the third quarter of 2018 (Q3’18) were 319.3 thousand, up 35.3% year-over-year. Americas and International region case shipments were up year-over-year 29.1% and 45.6%, respectively. Q3’18 Invisalign cases for teenage patients were 98.5 thousand, up 41.1% year-over-year. Q3’18 revenues were $505.3 million, up 31.2% year-over-year and Q3’18 operating income was $125.2 million, up 26.8% year-over-year resulting in an operating margin of 24.8%. Net profit was $100.9 million, or $1.24 per diluted share, up $0.23 year-over-year.

Commenting on Align’s Q3 2018 results, Align Technology President and CEO Joe Hogan said, “I’m pleased to report third quarter results with revenue and earnings above our outlook driven by higher than expected Invisalign volume -- offset somewhat by lower ASPs and foreign exchange. We also had another record quarter for the iTero scanner business with revenues up 79.1% year-over-year. Q3 Invisalign volume increased 5.5% sequentially and up 35.3% year-over-year reflecting strength across regions and customer channels, as well as strong growth from both teen and adult patients. From a product perspective, we saw strength across the Invisalign portfolio with growth from both comprehensive and non-comprehensive products, reflecting an acceleration in the non-comprehensive category related to expansion of our product portfolio, as well as new sales programs and promotions intended to increase adoption and utilization. We also saw continued strength from international regions, especially Asia Pacific, which was our 2nd largest region after the Americas in Q3.”

GAAP Summary Financial Comparisons
Third Quarter Fiscal 2018

Q3’18Q2’18Q3’17 Q/Q Change Y/Y Change
Invisalign Case Shipments1319,345302,685236,065+5.5%+35.3%
Net Revenues$505.3M$490.3M$385.3M+3.1%+31.2%
Clear Aligner2$427.1M$433.2M$341.6M(1.4)%+25.0%
Scanner & Services$78.2M$57.0M$43.7M+37.2%+79.1%
Net Profit$100.9M$106.1M$82.6M(4.9)%+22.2%
Diluted EPS$1.24$1.30$1.01$(0.06)+$0.23

Note: Changes and percentages are based on actual values and may affect totals due to rounding
1 Invisalign shipment figures do not include SmileDirectClub aligners
2 Clear aligner revenue includes revenues from Invisalign clear aligners and SmileDirectClub aligners

As of September 30, 2018, Align had $613.2 million in cash, cash equivalents and marketable securities compared to $720.7 million as of June 30, 2018. During Q3’18, we repurchased $150.0 million of our stock against our stock buy-back authorizations and have $550.0 million still available for repurchase under the May 2018 Repurchase Program.

Announcements and Highlights

During the third quarter Align announced the following:

Q4 2018 Business Outlook

For the fourth quarter of 2018 (Q4’18), Align provides the following guidance:

Align Web Cast and Conference Call
Align will host a conference call today, October 24, 2018 at 4:30 p.m. ET, 1:30 p.m. PT, to review its third quarter 2018 results, discuss future operating trends and the business outlook. The conference call will also be web cast live via the Internet. To access the webcast, go to the “Events & Presentations” section under Company Information on Align’s Investor Relations web site at http://investor.aligntech.com. To access the conference call, please dial 201-689-8261. An archived audio web cast will be available beginning approximately one hour after the call's conclusion and will remain available for approximately 12 months. Additionally, a telephonic replay of the call can be accessed by dialing 877-660-6853 with conference number 13683414 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 November 7, 2018.

About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign® system, the most advanced clear aligner system in the world, and iTero® intraoral scanners and services. Align’s products help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients. Visit www.aligntech.com for more information.

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

Forward-Looking Statement
This news release, including the tables below, contains forward-looking statements, including statements regarding certain business metrics for the fourth quarter of 2018, including, but not limited to, anticipated net revenues, gross margin, operating expenses, operating profit, diluted earnings per share, tax rate including the financial impact of recent U.S. Tax Cuts and Jobs Act and case shipments. 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, Align's ability to protect its intellectual property rights, continued compliance with regulatory requirements, competition from existing and new competitors, the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers, the possibility that the development and release of new products does not proceed in accordance with the anticipated timeline, the possibility that the market for the sale of these new products may not develop as expected, or that the expected benefits of new or existing business relationships will not be achieved as anticipated, risks relating to international sales, which are increasingly a larger portion of our total revenues, 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, the security of customer and/or patient data is compromised for any reason, 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, changes to our interpretation of the U.S. Tax Cuts and Jobs Act which may change as we receive additional clarification and implementation guidance, possibly materially, foreign operational, political and other risks relating to Align's international manufacturing operations, litigation risks, uncertainties involved in any contract dispute resolution and the possibility of Align choosing to settle the litigation for business or other reasons. 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, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 28, 2018. 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
September 30,
Nine Months Ended
September 30,
2018 2017 2018 2017
Net revenues $ 505,289 $ 385,267 $ 1,432,472 $ 1,052,090
Cost of net revenues 133,508 92,779 367,701 253,060
Gross profit 371,781 292,488 1,064,771 799,030
Operating expenses:
Selling, general and administrative 213,873 169,524 625,585 483,636
Research and development 32,700 24,201 93,095 71,389
Total operating expenses 246,573 193,725 718,680 555,025
Income from operations 125,208 98,763 346,091 244,005
Interest income 2,234 1,826 6,327 4,462
Other income (expense), net (837) 1,924 (7,759) 4,145
Net income before provision for income taxes and equity in losses of investee 126,605 102,513 344,659 252,612
Provision for income taxes 24,601 18,344 35,206 26,508
Equity in losses of investee, net of tax 1,132 1,614 6,610 4,950
Net income $ 100,872 $ 82,555 $ 302,843 $ 221,154
Net income per share:
Basic $ 1.26 $ 1.03 $ 3.78 $ 2.76
Diluted $ 1.24 $ 1.01 $ 3.71 $ 2.71
Shares used in computing net income per share:
Basic 80,111 80,163 80,122 80,086
Diluted 81,359 81,789 81,538 81,757
* During Q1'18, we adopted the ASC 606, "Revenues from Contracts with Customers" using the full retrospective method. The adoption of ASC 606 did not have a material impact on our Condensed Consolidated Statements of Operations presented herein.

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS*
(in thousands)
September 30,
2018
December 31,
2017
ASSETS
Current assets:
Cash and cash equivalents $420,860 $449,511
Marketable securities, short-term 184,297 272,031
Accounts receivable, net 420,276 324,189
Inventories 48,858 31,688
Prepaid expenses and other current assets 149,891 80,948
Total current assets 1,224,182 1,158,367
Marketable securities, long-term 8,091 39,948
Property, plant and equipment, net 491,630 348,793
Equity method investments 47,996 54,606
Goodwill and intangible assets, net 83,607 89,068
Deferred tax assets 47,435 49,334
Other assets 25,464 43,893
Total assets $1,928,405 $1,784,009
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $43,065 $36,776
Accrued liabilities 219,035 195,562
Deferred revenues 356,109 267,713
Total current liabilities 618,209 500,051
Income tax payable 95,655 114,091
Other long-term liabilities 21,558 15,579
Total liabilities 735,422 629,721
Total stockholders' equity 1,192,983 1,154,288
Total liabilities and stockholders' equity $1,928,405 $1,784,009
* During Q1'18, we adopted the ASC 606, "Revenues from Contracts with Customers" using the full retrospective method. Condensed Consolidated Balance Sheet as of December 31,2017 has been recasted to comply with the adoption.

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS*
(in thousands)
Nine Months Ended
September 30,
2018 2017
CASH FLOWS FROM OPERATING ACTIVITIES
Net income $302,843 $221,154
Net cash provided by operating activities 313,386 276,213
CASH FLOWS FROM INVESTING ACTIVITIES
Net cash used in investing activities (24,021) (231,784)
CASH FLOWS FROM FINANCING ACTIVITIES
Net cash used in financing activities (315,151) (79,036)
Effect of foreign exchange rate changes on cash, cash equivalents, and restricted cash (2,890) 4,806
Net decrease in cash, cash equivalents, and restricted cash (28,676) (29,801)
Cash, cash equivalents, and restricted cash at beginning of the period 450,125 393,019
Cash, cash equivalents, and restricted cash at end of the period $421,449 $363,218
*During Q1'18, we adopted ASU 2016-18, "Statement of Cash Flows - Restricted Cash" on a retrospective basis. Condensed Consolidated Statement of Cash Flows for the nine months ended September 30, 2017 has been recasted to comply with the adoption.

ALIGN TECHNOLOGY, INC.
INVISALIGN BUSINESS METRICS*
Q1 Q2 Q3 Q4 Fiscal Q1 Q2 Q3
2017 2017 2017 2017 2017 2018 2018 2018
Invisalign Average Selling Price (ASP):
Worldwide ASP $ 1,270 $ 1,285 $ 1,310 $ 1,305 $ 1,295 $ 1,310 $ 1,315 $ 1,230
International ASP $ 1,345 $ 1,340 $ 1,395 $ 1,400 $ 1,375 $ 1,435 $ 1,425 $ 1,340
Invisalign Cases Shipped by Geography:
Americas 134,450 148,470 147,660 155,625 586,205 166,665 181,425 190,615
International 73,610 83,420 88,405 99,405 344,840 105,570 121,260 128,730
Total Cases Shipped 208,060 231,890 236,065 255,030 931,045 272,235 302,685 319,345
YoY % growth 27.1% 31.0% 32.8% 34.2% 31.4% 30.8% 30.5% 35.3%
QoQ % growth 9.5% 11.5% 1.8% 8.0% 6.7% 11.2% 5.5%
Number of Invisalign Doctors Cases Were Shipped To:
Americas 24,595 25,570 25,865 26,480 38,230 27,105 28,280 28,890
International 14,270 15,695 16,740 18,505 26,175 19,700 21,805 23,270
Total Doctors Cases Shipped To 38,865 41,265 42,605 44,985 64,405 46,805 50,085 52,160
Invisalign Doctor Utilization Rates**:
North America 5.6 5.9 5.8 6.0 15.8 6.3 6.6 6.9
North American Orthodontists 12.6 13.6 13.8 14.0 46.6 15.3 16.4 17.4
North American GP Dentists 3.1 3.3 3.1 3.3 8.2 3.4 3.6 3.5
International 5.2 5.3 5.3 5.4 13.2 5.4 5.6 5.5
Total Utilization Rates 5.4 5.6 5.5 5.7 14.5 5.8 6.0 6.1
Number of Invisalign Doctors Trained***:
Americas 1,050 1,825 1,980 1,760 6,615 1,630 1,880 2,085
International 2,220 3,055 2,540 2,400 10,215 2,645 3,300 2,845
Total Doctors Trained Worldwide 3,270 4,880 4,520 4,160 16,830 4,275 5,180 4,930
Total to Date Worldwide 118,740 123,620 128,140 132,300 132,300 136,575 141,755 146,685
Note: Historical public data may differ due to rounding. Additionally, rounding may effect totals. Effective Q1'18, Americas region includes North America and LATAM. International region includes EMEA and APAC. We have recasted historical data to reflect the change.
* Invisalign business metrics exclude SmileDirectClub aligners.
** # of cases shipped / # of doctors to whom cases were shipped. LATAM utilization rate is not separately disclosed, but included in the total utilization rates.
***2018 and 2017 adjusted to reflect Americas doctors trained for Invisalign iGo
ALIGN TECHNOLOGY, INC.
STOCK-BASED COMPENSATION
(in thousands)
Q1 Q2 Q3 Q4 Fiscal Q1 Q2 Q3
2017 2017 2017 2017 2017 2018 2018 2018
Stock-based Compensation (SBC)
SBC included in Gross Profit $ 925 $ 768 $ 833 $ 804 $ 3,330 $ 881 $ 900 $ 966
SBC included in Operating Expenses 13,887 13,477 14,134 14,026 55,524 14,949 15,990 18,232
Total SBC Expense $ 14,812 $ 14,245 $ 14,967 $ 14,830 $ 58,854 $ 15,830 $ 16,890 $ 19,198

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)
Q4'18 Guidance
GAAP
Net Revenues $505.0 - $515.0
Gross Margin 72.3% - 73.0%
Operating Expenses $248.0 - $253.0
Operating Margin 23.2% - 23.9%
Net Income per Diluted Share $1.10 - $1.15(1,2)
Business Metrics: Q4'18
Case Shipments 330.0K - 335.0K
Capital Expenditure $50M - $55M
Depreciation & Amortization $15M - $16M
Diluted Shares Outstanding 81.3M(2)
Stock Based Compensation Expense $19.1M
Effective Tax Rate ~22.5%(1)
(1) Includes excess tax benefits related to share-based compensation expense pursuant to ASU 2016-09
(2) Excludes any stock repurchases during the quarter

Align Technology
Madelyn Homick
(408) 470-1180
[email protected]

Ethos Communication
Shannon Mangum Henderson
(678) 261-7803
[email protected]

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