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Align Technology Announces Record 2018 Financial Results

January 29, 2019 4:00 PM

SAN JOSE, Calif., Jan. 29, 2019 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the fourth quarter (Q4’18) and year ended December 31, 2018 (FY 2018). Q4’18 Invisalign volume was 333.8 thousand cases, up 30.9% year-over-year. For the Americas and International regions, Q4’18 Invisalign volume was up 21.7% and 45.3% year-over-year, respectively. Q4’18 Invisalign volume for teenage patients was 87.1 thousand cases, up 37.3% year-over-year. Q4’18 total revenues were $534.0 million, up 26.7% year-over-year, and Q4’18 scanner and services revenues were $88.4 million, up 54.8% year-over-year. Q4’18 operating income of $120.5 million was up 9.9% year-over-year resulting in an operating margin of 22.6%. Q4’18 net profit was $97.4 million, or $1.20 per diluted share.

For 2018, record Invisalign revenues were $1.7 billion, up 29.4% year-over-year with Invisalign case shipments of 1.2 million, up 31.9% year-over-year. 2018 iTero revenues were $275.0 million, up 67.5% year-over-year with record volume, up 77.2% year-over-year. 2018 Invisalign cases for teenage patients were 333.1 thousand, up 40.3% year-over-year. For 2018, total revenues were $2.0 billion, up 33.5% year-over-year, and net profit was $400.2 million, or $4.92 per diluted share.

Commenting on Align’s Q4 and 2018 results, Align Technology President and CEO Joe Hogan said, “Our fourth quarter was a strong finish to a great year. Q4 revenues were better than expected reflecting higher Invisalign ASPs and volume growth of 31% year-over-year, as well as another record quarter for our iTero scanners with revenue up 55% year-over-year. Q4 sequential growth was driven by a strong quarter for EMEA with record growth from teens, as well as continued traction with Invisalign Lite and Invisalign Go. Q4 operating margin of 22.6% reflects higher doctor training and manufacturing costs, as well as higher legal fees than anticipated, partially offset by a sequential improvement in Invisalign ASPs.”

Hogan continued, “We achieved record revenues of nearly $2.0 billion for the year and had over 1.2 million people start treatment with Invisalign clear aligners the first time, resulting in our 6th millionth Invisalign patient – a teenager from China. These results reflect record revenues and volumes for both Invisalign and iTero across customer channels and country markets, and continued strength from teens, which grew 40.3%. The total number of teenagers treated with Invisalign this year was over 333 thousand representing 27.1% of our volume. Finally, in 2018, we trained a record number of new Invisalign doctors – nearly 20 thousand worldwide – and more than half of them were international doctors.”

GAAP Summary Financial ComparisonsFourth Quarter Fiscal 2018

Q4’18Q3’18Q4’17 Q/Q Change Y/Y Change
Invisalign Case Shipments1 333,800 319,345 255,030 +4.5% +30.9%
Net Revenues$534.0M$505.3M$421.3M +5.7% +26.7%
Clear Aligner2$445.6M$427.1M$364.2M +4.3% +22.4%
Scanner & Services$88.4M$78.2M$57.1M +13.0% +54.8%
Net Profit$97.4M$100.9M$10.3M (3.4)% +848.9%
Diluted EPS3$1.20$1.24$0.13$(0.04) $1.07

Fiscal 2018

2018 2017 Y/Y Change
Invisalign Case Shipments1 1,228,065 931,045 +31.9%
Net Revenues $1,966.5M$1,473.4M +33.5%
Clear Aligner2 $1,691.5M$1,309.3M +29.2%
Scanner & Services $275.0M$164.2M +67.5%
Net Profit $400.2M$231.4M +72.9%
Diluted EPS3 $4.92$2.83 +$2.09

Note: Changes and percentages are based on actual values and may affect totals due to rounding1 Invisalign shipment figures do not include SmileDirectClub aligners 2 Clear aligner revenue includes revenues from Invisalign clear aligners and SmileDirectClub aligners3 Q4’17 includes deemed repatriation tax impact of $1.06

As of December 31, 2018, Align had $744.5 million in cash, cash equivalents and marketable securities compared to $761.5 million as of December 31, 2017. During Q4’18, we repurchased $50.0 million of our stock against our stock buy-back authorizations and have $500.0 million still available for repurchase under the May 2018 Repurchase Program.

2018 Business Highlights

The following list highlights Align’s key announcements over the past year:

Invisalign and iTero Intraoral Scanner

Invisalign Experience Program

Patient Milestones

International Expansion

Research and Awards

Corporate

Q1 2019 Business OutlookFor the first quarter of 2019 (Q1’19), Align provides the following guidance:

Align Web Cast and Conference Call

Align will host a conference call today, January 29, 2019 at 4:30 p.m. ET, 1:30 p.m. PT, to review its fourth quarter and year ended 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 13685779 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 12, 2019.

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 first quarter of 2019, including, but not limited to, anticipated net revenues, gross margin, operating expenses, operating profit, diluted earnings per share, tax rate 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, 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 excess or constrained capacity at our manufacturing and treat operations facilities 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 as well as an increased manufacturing costs per case, 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 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, and its latest Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, which was filed with the SEC on November 1, 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 December 31, Year Ended December 31,
2018 2017 2018 2017
Net revenues $534,020 $421,323 $1,966,492 $1,473,413
Cost of net revenues 150,924 103,406 518,625 356,466
Gross profit 383,096 317,917 1,447,867 1,116,947
Operating expenses:
Selling, general and administrative 226,819 182,141 852,404 665,777
Research and development 35,804 26,170 128,899 97,559
Total operating expenses 262,623 208,311 981,303 763,336
Income from operations 120,473 109,606 466,564 353,611
Interest income 2,249 2,486 8,576 6,948
Other income (expense), net (730) 95 (8,489) 4,240
Net income before provision for income taxes and equity in losses of investee 121,992 112,187 466,651 364,799
Provision for income taxes** 22,517 103,654 57,723 130,162
Equity in losses (gains) of investee, net of tax 2,083 (1,731) 8,693 3,219
Net income $97,392 $10,264 $400,235 $231,418
Net income per share:
Basic $1.22 $0.13 $5.00 $2.89
Diluted $1.20 $0.13 $4.92 $2.83
Shares used in computing net income per share:
Basic 79,891 80,080 80,064 80,085
Diluted 80,943 81,863 81,357 81,832
* 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.
** During Q4'17, the U.S. Tax Cuts and Jobs Act was enacted into law and we recorded the tax impacts in our provision for income taxes.

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS*
(in thousands)
December 31, 2018 December 31, 2017
ASSETS
Current assets:
Cash and cash equivalents $636,899 $449,511
Marketable securities, short-term 98,460 272,031
Accounts receivable, net 439,009 324,189
Inventories 55,641 31,688
Prepaid expenses and other current assets 72,470 80,948
Total current assets 1,302,479 1,158,367
Marketable securities, long-term 9,112 39,948
Property, plant and equipment, net 521,329 348,793
Equity method investments 45,913 54,606
Goodwill and intangible assets, net 81,949 89,068
Deferred tax assets 64,689 49,334
Other assets 26,987 43,893
Total assets $2,052,458 $1,784,009
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $64,256 $36,776
Accrued liabilities 234,679 195,562
Deferred revenues 393,138 267,713
Total current liabilities 692,073 500,051
Income tax payable 78,008 114,091
Other long-term liabilities 29,486 15,579
Total liabilities 799,567 629,721
Total stockholders' equity 1,252,891 1,154,288
Total liabilities and stockholders' equity $2,052,458 $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)
Year Ended December 31,
2018 2017
CASH FLOWS FROM OPERATING ACTIVITIES
Net cash provided by operating activities $554,681 $438,539
CASH FLOWS FROM INVESTING ACTIVITIES
Net cash provided by (used in) investing activities 6,927 (251,477)
CASH FLOWS FROM FINANCING ACTIVITIES
Net cash used in financing activities (369,434) (135,500)
Effect of foreign exchange rate changes on cash, cash equivalents, and restricted cash (4,733) 5,544
Net decrease in cash, cash equivalents, and restricted cash 187,441 57,106
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 $637,566 $450,125
*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 year ended December 31, 2017 has been recasted to comply with the adoption.

ALIGN TECHNOLOGY, INC.
INVISALIGN BUSINESS METRICS*
Q4 Fiscal Q1 Q2 Q3 Q4 Fiscal
2017 2017 2018 2018 2018 2018 2018
Invisalign Average Selling Price (ASP):
Worldwide ASP $ 1,305 $ 1,295 $ 1,310 $ 1,315 $ 1,230 $ 1,235 $ 1,270
International ASP $ 1,400 $ 1,375 $ 1,435 $ 1,425 $ 1,340 $ 1,295 $ 1,370
Invisalign Cases Shipped by Geography:
Americas 155,625 586,205 166,665 181,425 190,615 189,410 728,115
International 99,405 344,840 105,570 121,260 128,730 144,390 499,950
Total Cases Shipped 255,030 931,045 272,235 302,685 319,345 333,800 1,228,065
YoY % growth 34.2% 31.4% 30.8% 30.5% 35.3% 30.9% 31.9%
QoQ % growth 8.0% 6.7% 11.2% 5.5% 4.5%
Number of Invisalign Doctors Cases Were Shipped To:
Americas 26,480 38,230 27,105 28,280 28,890 29,215 42,000
International 18,505 26,175 19,700 21,805 23,270 25,475 36,040
Total Doctors Cases Shipped To 44,985 64,405 46,805 50,085 52,160 54,690 78,040
Invisalign Doctor Utilization Rates**:
North America 6.0 15.8 6.3 6.6 6.9 6.7 18.2
North American Orthodontists 14.0 46.6 15.3 16.4 17.4 16.5 56.7
North American GP Dentists 3.3 8.2 3.4 3.6 3.5 3.6 9.1
International 5.4 13.2 5.4 5.6 5.5 5.7 13.9
Total Utilization Rates 5.7 14.5 5.8 6.0 6.1 6.1 15.7
Number of Invisalign Doctors Trained***:
Americas 1,760 6,615 1,630 1,880 2,085 2,290 7,885
International 2,400 10,215 2,645 3,300 2,845 2,980 11,770
Total Doctors Trained Worldwide 4,160 16,830 4,275 5,180 4,930 5,270 19,655
Total to Date Worldwide 132,300 132,300 136,575 141,755 146,685 151,955 151,955
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)
Q4 Fiscal Q1 Q2 Q3 Q4 Fiscal
2017 2017 2018 2018 2018 2018 2018
Stock-based Compensation (SBC)
SBC included in Gross Profit $ 804 $ 3,330 $ 881 $ 900 $ 966 $ 948 $ 3,695
SBC included in Operating Expenses 14,026 55,524 14,949 15,990 18,232 17,897 67,068
Total SBC Expense $ 14,830 $ 58,854 $ 15,830 $ 16,890 $ 19,198 $ 18,845 $ 70,763

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)
Q1'19 Guidance
GAAP
Net Revenues $525.0 - $535.0
Gross Margin 70.3% - 71.0%
Operating Expenses $289.8 - $293.8
Operating Margin 15.1% - 16.1%
Net Income per Diluted Share $0.78 - $0.84
Business Metrics: Q1'19
Case Shipments 340.0K - 345.0K
Capital Expenditure $60M - $65M
Depreciation & Amortization $19M - $20M
Diluted Shares Outstanding 80.9M(2)
Stock Based Compensation Expense $19.9M
Effective Tax Rate ~16%(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 TechnologyMadelyn Homick (408) 470-1180 [email protected]

Zeno GroupSarah Johnson(828) 551-4201[email protected]

Align_Digital_Primary.jpg

Source: Align Technology, Inc.

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