Align Technology 10-K 2019-12-31
Filed 2020-02-28. 21 sections, 423K characters. Original on sec.gov · Markdown · JSON
Cover and table of contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
| ☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2019
OR
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 000-32259
ALIGN TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 94-3267295 |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
2820 Orchard Parkway
San Jose**,** California 95134
(Address of principal executive offices)
(408) 470-1000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered |
| Common Stock, $0.0001 par value | ALGN | The NASDAQ Stock Market LLC (NASDAQ Global Market) |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
| Large accelerated filer | ☒ | Accelerated filer | ☐ |
| Non-accelerated filer | ☐ | Smaller reporting company | ☐ |
| Emerging growth company | ☐ | ||
| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately $15.9 billion as of June 28, 2019 based on the closing sale price of the registrant’s common stock on the NASDAQ Global Market on such date. Shares held by persons who may be deemed affiliates have been excluded. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
On February 21, 2020, 78,753,161 shares of the registrant’s common stock were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive Proxy Statement relating to its 2020 Annual Stockholders’ Meeting to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year end of December 31, 2019 are incorporated by reference into Part III of this Annual Report on Form 10-K.
ALIGN TECHNOLOGY, INC.
FORM 10-K
For the Year Ended December 31, 2019
TABLE OF CONTENTS
| Page | ||
| PART I | 3 | |
| Item 1. | Business | 3 |
| Executive Officers of the Registrant | 12 | |
| Item 1A. | Risk Factors | 13 |
| Item 1B. | Unresolved Staff Comments | 27 |
| Item 2. | Properties | 27 |
| Item 3. | Legal Proceedings | 27 |
| Item 4. | Mine Safety Disclosures | 27 |
| PART II | 28 | |
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 28 |
| Item 6. | Selected Consolidated Financial Data | 29 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 30 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 44 |
| Item 8. | Consolidated Financial Statements and Supplementary Data | 45 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 86 |
| Item 9A. | Controls and Procedures | 87 |
| Item 9B. | Other Information | 87 |
| PART III | 87 | |
| Item 10. | Directors, Executive Officers and Corporate Governance | 87 |
| Item 11. | Executive Compensation | 87 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 88 |
| Item 13. | Certain Relationships and Related Transactions and Director Independence | 88 |
| Item 14. | Principal Accounting Fees and Services | 88 |
| PART IV | 89 | |
| Item 15. | Exhibits, Financial Statement Schedules | 89 |
| Item 16. | Form 10-K Summary | 91 |
| Signatures | 92 |
Invisalign, Align, the Invisalign logo, ClinCheck, Made to Move, Invisalign Assist, Invisalign Teen, Invisalign Go, Vivera, SmartForce, SmartTrack, SmartStage, SmileView, iTero, iTero Element, Orthocad, iCast and iRecord, among others, are trademarks and/or service marks of Align Technology, Inc. or one of its subsidiaries or affiliated companies and may be registered in the United States and/or other countries.
In addition to historical information, this annual report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements include, among other things, our estimates concerning the number of people who can benefit from our products, expectations regarding the anticipated impact of our new products and product enhancements will have on the future of dentistry, doctor utilization and our market share, our beliefs regarding our technology development and the advantages of our intellectual property portfolio, our beliefs concerning our compliance with domestic and foreign laws and regulations, including data protection and security, our expectations regarding geographic and product mix and product adoption, our expectations for domestic and international growth, our expectations regarding the existence and impact of seasonality, our expectations regarding the sales growth of our iTero scanners, their utilization and the potential growth opportunities iTero scanners represent to our overall business, our beliefs concerning the manufacturing capabilities and expectations regarding the financial and strategic benefits of establishing regional order acquisition, treatment planning and manufacturing facilities, our expectations for competition, our expectations concerning the impact of the Novel Coronavirus on our sales and operating results, our intention to hire more sales representatives and their expected impact on our sales, our expectations regarding the continued expansion of our domestic and international markets including related infrastructure and staffing, our expectations related to our corporate structure reorganization, the level of our operating expenses, capital expenditures and gross margins, our intentions regarding earnings from international operations, our beliefs concerning our investment portfolio and the funding of our operations and other factors beyond our control, as well as other statements regarding our future operations, financial condition and prospects and business strategies. These statements may contain words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” or other words indicating future results. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in particular, the risks discussed below in Part I, Item 1A “Risk Factors.” We undertake no obligation to revise or update these forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.
PART I
Item 1. BUSINESS
Our Company
Align Technology, Inc. (“We”, “Our”, “Align”) is a global medical device company engaged in the design, manufacture and marketing of Invisalign® clear aligners and iTero® intraoral scanners and services for orthodontics, and restorative and aesthetic dentistry. Align’s products are intended primarily for the treatment of malocclusion or the misalignment of teeth and are designed to help dental professionals achieve the clinical outcomes that they expect. Align Technology was founded in March 1997 and incorporated in Delaware in April 1997. Our corporate headquarters is located at 2820 Orchard Parkway, San Jose, California, U.S.A., 95134, and our telephone number is 408-470-1000. Our internet address is www.aligntech.com. Our Americas regional headquarters is located in Raleigh, North Carolina, U.S.A.; our European, Middle East and Africa (“EMEA”) regional headquarters is located in Rotkreuz, Switzerland, which moved from Amsterdam, the Netherlands in January 2020; and our Asia Pacific ("APAC") regional headquarters is located in Singapore.
We have two operating segments: (1) Clear Aligner and (2) Scanners and Services ("Scanner"). For the year ended December 31, 2019, Clear Aligner net revenues represented approximately 84% of worldwide net revenues, while Scanner net revenues represented the remaining 16% of worldwide net revenues. We sell the majority of our products directly to our customers: orthodontists and general practitioner dentists ("GPs"), as well as to restorative and aesthetic dentists, including prosthodontists, periodontists, and oral surgeons. We also sell through sales agents and distributors in certain countries. In addition, we sell directly to Dental Support Organizations ("DSOs") who contract with dental practices to provide critical business management and support including non-clinical operations, and we sell directly to dental laboratories who manufacture or customize a variety of products used by licensed dentists to provide oral health care.
We received 510(k) clearance from the United States Food and Drug Administration (“FDA”) to market the Invisalign System in 1998. The Invisalign System is regulated by the FDA as a Class II medical device. In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training course. The Invisalign System is sold primarily through a direct sales force in North America, APAC, Europe, EMEA and Latin America ("LATAM"). To date, over 8 million people worldwide have been treated with our Invisalign System.
Our iTero scanner is used by dental professionals and/or labs and service providers for restorative and orthodontic digital procedures as well as Invisalign case submission. We received 510(k) clearance from the FDA to market iTero software for expanded indications in 2013. Scanners and computer-aided design/computer-aided manufacturing ("CAD/CAM") services are primarily
sold through our direct sales force and through sales agents and distributors in certain countries. In addition, we sell iTero scanners and CAD/CAM services directly to DSOs.
Clear Aligner Segment
Malocclusion and Traditional Orthodontic Treatment
Malocclusion, or the misalignment of teeth, is one of the most prevalent clinical dental conditions, affecting billions of people, or approximately 60% to 75% of the global population. Annually, approximately 12 million people in major developed countries elect treatment by orthodontists worldwide. Most orthodontic patients are treated with the use of traditional methods such as metal arch wires and brackets, referred to as braces, and may be augmented with elastics, metal expanders, headgear or functional appliances, and other ancillary devices as needed. Upon completion of the treatment, the dental professional may, at his or her discretion, have the patient use a retainer appliance. Of the 12 million annual orthodontic cases started, we estimate that approximately 75% or 8.4 million could be treated using our Invisalign clear aligners. In addition, approximately 300 million people with malocclusion could benefit from straightening their teeth. This represents an incremental opportunity for us as we expand the market for orthodontics by educating more consumers about the benefits of straighter teeth using Invisalign clear aligners and connecting them with an Invisalign doctor of their choice.
The Invisalign System
The Invisalign System is a proprietary method for treating malocclusion based on a proprietary computer-simulated virtual treatment plan and a series of doctor-prescribed, custom manufactured, clear plastic removable aligners. The Invisalign System offers a range of treatment options, specialized services, and access to proprietary software for treatment visualization and is comprised of the following phases:
Orthodontic diagnosis and transmission of treatment data to us. The Invisalign-trained dental professional prepares an online prescription form on our Invisalign Doctor Site and submits the patient's records, which include a digital intraoral scan or a polyvinyl-siloxane ("PVS") impression of the relevant dental arches, photographs of the patient and, at the dental professional’s election, x-rays of the patient’s dentition. Intraoral digital scans may be submitted through either Align's iTero scanner or certain third-party scanners capable of accurately interfacing with our systems and processes. See "Third Party Scanners and Digital scans for Invisalign treatment submission." More than 73% of Invisalign case submissions are now submitted via digital scan, increasing the accuracy of treatments, reducing the time from prescription submission to patient receipt, and decreasing the carbon footprint resulting from the shipment of the materials used to form the physical PVS impressions and shipping those PVS impressions to us.
Preparation of computer-simulated treatment plan. Using the information and digital data provided, we generate a proposed custom, three-dimensional treatment plan, called a ClinCheck treatment plan using our proprietary software, which is not for sale or license. A patient’s ClinCheck treatment plan simulates expected tooth movement in stages and details the timing and placement of any features or attachments to be used during treatment. Attachments are tooth-colored “buttons” that are sometimes used to increase the biomechanical force on a specific tooth or teeth in order to effect the desired movement(s).
Review and approval of the treatment plan by an Invisalign-trained doctor. The patient’s ClinCheck treatment plan is then made available to the prescribing dental professional via the Invisalign Doctor Site which enables the dental professional to project tooth movement from initial position to final position and compare multiple treatment plan options. By reviewing, modifying as needed and approving the treatment plan, the dental professional retains control of the patient's treatment.
Manufacture of custom aligners. Upon the dental professional’s approval of the ClinCheck treatment plan, we use the data underlying the simulation, in conjunction with stereolithography technology (a form of 3D printing technology), to construct a series of molds depicting the future position of the patient’s teeth. Each mold is a replica of the patient’s teeth at each stage of the simulated course of treatment. From these molds, aligners are fabricated by pressure-forming polymeric sheets over each mold. Aligners are thin, clear plastic, removable dental appliances that are custom manufactured in a series to correspond to each stage of the patient's ClinCheck treatment plan.
Shipment to the dental professional and patient aligner wear. In most countries, all the aligners for a patient's treatment plan are shipped directly to the dental professional, who then dispenses them to the patient at regular check-up intervals throughout the treatment. Aligners
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Item 1B. UNRESOLVED STAFF COMMENTS
None.
Item 2. PROPERTIES
We occupy several leased and owned facilities. At December 31, 2019, the significant facilities occupied were as follows:
| Location | Lease/Own | Primary Use | Expiration of Lease |
| San Jose, California, U.S.A. | Own | Office for corporate headquarters, research & development and administrative personnel | N/A |
| Raleigh, North Carolina, U.S.A | Own | Office for Americas regional headquarters | N/A |
| San Jose, Costa Rica | Lease and Own | Office for administrative personnel, treatment personnel, and customer care | July 2023 |
| Moscow, Russia | Lease | Office for research & development | March 2024 |
| Or Yehuda, Israel | Lease and Own | Manufacturing and office for research & development and administrative personnel | February 2022 |
| Rotkreuz, Switzerland | Lease | Office for EMEA regional headquarters, sales and marketing and administrative personnel | July 2024 |
| Juarez, Mexico | Own | Manufacturing and office for administrative personnel | N/A |
| Ziyang, China | Lease and Own | Manufacturing and office for administrative personnel | May 2021 |
Item 3. LEGAL PROCEEDINGS
For a discussion of legal proceedings, refer to Note 9 "Legal Proceedings" of the Notes to the Consolidated Financial Statements in Part II, Item 8 of this Form 10-K.
Item 4. MINE SAFETY DISCLOSURES
Not applicable.
PART II
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
As of February 21, 2020, there were approximately 70 holders of record of our common stock. Because the majority of our shares of outstanding common stock are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of stockholders represented by these record holders.
Performance Graph
Notwithstanding any statement to the contrary in any of our previous or future filings with the SEC, the following information relating to the price performance of our common stock shall not be deemed “filed” with the SEC or “Soliciting Material” under the Securities Exchange Act of 1934, as amended, or subject to Regulation 14A or 14C, or to liabilities of Section 18 of the Exchange Act except to the extent we specifically request that such information be treated as soliciting material or to the extent we specifically incorporate this information by reference.
The graph below matches our cumulative 5-year total stockholder return on common stock with the cumulative total returns of the NASDAQ Composite index, the S&P 500 and the S&P 1500 Composite Health Care Equipment & Supplies index. The graph tracks the performance of a $100 investment in our common stock, in the peer group, and the index (with the reinvestment of all dividends) from December 31, 2014 to December 31, 2019.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Following is a summary of stock repurchases for the three months ended December 31, 2019:
| Period | Total Number of Shares Repurchased | Average Price Paid per Share | Total Number of Shares Repurchased as Part of Publicly Announced Program | Approximate Dollar Value of Shares that May Yet Be Repurchased Under the Program 1 | ||||||||||
| October 1, 2019 through October 31, 2019 | — | $ | — | — | $ | 200,500,000 | ||||||||
| November 1, 2019 through November 30, 2019 | 388,510 | $ | 258.67 | 388,510 | $ | 100,000,000 | ||||||||
| December 1, 2019 through December 31, 2019 | — | $ | — | — | $ | 100,000,000 |
| 1 | In November 2019, we repurchased $100.5 million of our common stock on the open market. As of December 31, 2019, we have $100.0 million available for repurchase under the $600.0 million repurchase program authorized by our Board of Directors in May 2018 (Refer to Note 12 “Common Stock Repurchase Programs” of the Notes to Consolidated Financial Statements). |
Item 6. SELECTED CONSOLIDATED FINANCIAL DATA
The following selected consolidated financial data should be read in conjunction with the consolidated financial statements and accompanying notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations.
| Fiscal Year | |||||||||||||||||||
| 2019 | 2018 | 2017 2 | 2016 2 | 2015 | |||||||||||||||
| (in thousands, except per share data) | |||||||||||||||||||
| Statement of Operations Data: | |||||||||||||||||||
| Net revenues | $ | 2,406,796 | $ | 1,966,492 | $ | 1,473,413 | $ | 1,079,874 | $ | 845,486 | |||||||||
| Gross profit | 1,743,897 | 1,447,867 | 1,116,947 | 815,294 | 640,110 | ||||||||||||||
| Income from operations | 542,493 | 466,564 | 353,611 | 248,921 | 188,634 | ||||||||||||||
| Interest income | 12,482 | 8,576 | 6,948 | 4,213 | 2,938 | ||||||||||||||
| Other income (expense), net | 7,676 | (8,489 | ) | 4,240 | (10,568 | ) | (5,471 | ) | |||||||||||
| Net income before provision for income taxes and equity in losses of investee | 562,651 | 466,651 | 364,799 | 242,566 | 186,101 | ||||||||||||||
| Provision for income taxes | 112,347 | 57,723 | 130,162 | 51,200 | 42,081 | ||||||||||||||
| Equity in losses of investee, net of tax | 7,528 | 8,693 | 3,219 | 1,684 | — | ||||||||||||||
| Net income | $ | 442,776 | $ | 400,235 | $ | 231,418 | $ | 189,682 | $ | 144,020 | |||||||||
| Net income per share: | |||||||||||||||||||
| Basic | $ | 5.57 | $ | 5.00 | $ | 2.89 | $ | 2.38 | $ | 1.80 | |||||||||
| Diluted | $ | 5.53 | $ | 4.92 | $ | 2.83 | $ | 2.33 | $ | 1.77 | |||||||||
| Shares used in computing net income per share: | |||||||||||||||||||
| Basic | 79,424 | 80,064 | 80,085 | 79,856 | 79,998 | ||||||||||||||
| Diluted | 80,100 | 81,357 | 81,832 | 81,484 | 81,521 | ||||||||||||||
| Financial Position Data: | |||||||||||||||||||
| Working capital 1 | $ | 662,449 | $ | 610,406 | $ | 658,316 | $ | 597,772 | $ | 460,338 | |||||||||
| Total assets | 2,500,702 | 2,052,458 | 1,784,009 | 1,402,305 | 1,158,633 | ||||||||||||||
| Total long-term liabilities | 183,563 | 107,494 | 129,670 | 46,427 | 39,035 | ||||||||||||||
| Stockholders’ equity | $ | 1,346,169 | $ | 1,252,891 | $ | 1,154,288 | $ | 999,307 | $ | 847,926 |
| 1 | Working capital is calculated as the difference between total current assets and total current liabilities. |
| 2 | Balances have been recast to reflect the adoption of ASC 606. We recognized a $3.9 million cumulative effect upon adoption as an adjustment to our opening balance of retained earnings as of January 1, 2016 in our Consolidated Statements of Stockholders’ Equity. Refer to Note 1 "Summary of Significant Accounting Policies" of the Notes to Consolidated Financial Statements for details). |
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read together with “Selected Consolidated Financial Data” and our consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K.
A discussion regarding our financial condition and results of operations for fiscal 2019 compared to fiscal 2018 is presented under Results of Operations of this Form 10-K. Discussions regarding our financial condition and results of operations for fiscal 2018 compared to 2017 have been omitted from this Annual Report on Form 10-K, but can be found in "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018, filed with the SEC on February 28, 2019, which is available without charge on the SEC's website at www.sec.gov and on our investor relations website at investor.aligntech.com.
Overview
Our goals are to establish Invisalign clear aligners as the standard method for treating malocclusion which, to date, over 8 million people worldwide have been treated with our Invisalign System, and to establish the iTero intraoral scanner as the preferred scanning device for 3D digital scans, ultimately driving increased clear aligner and other product adoption by dental professionals. We intend to achieve these goals by continued focus and execution of our strategic growth drivers set forth in the Business Strategy section of this Annual Report on Form 10-K.
The successful execution of our business strategy in 2020 and beyond may be affected by a number of factors including:
| • | New Invisalign Products and Feature Enhancements. We believe product innovation drives greater treatment predictability, clinical applicability and ease of use for the dental professionals we serve customers which supports adoption of Invisalign treatment in their practices. Our focus is to develop solutions and features to treat a wide range of cases from simple to complex. |
| • | We rolled out Invisalign treatment with Mandibular Advancement, the first clear aligner solution for Class II correction in growing tween and teen patients in multiple regions and countries throughout 2018. This offering combines the benefits of our clear aligner system with features for moving the lower jaw forward while simultaneously aligning the teeth without the need for elastics typically used to treat teen Class II patients. |
| • | In April 2018, we announced Invisalign Go product with more user-friendly iTero digital chairside experience and greater flexibility to treat a wider range of mild to moderate cases. Invisalign Go also incorporates new data-driven clinical protocols for predictable tooth movement and automated case assessments that leverages our Invisalign patients treated to date. These improvements make it easier for general practitioner (“GP”) dentists to tailor their treatment plans to the individual needs of each patient. |
| • | In July 2018, we announced Invisalign First clear aligners which are a treatment option designed with features specifically for younger patients with early mixed dentition with a mixture of primary/baby and permanent teeth. Phase 1 treatment is an early interceptive orthodontic treatment for young patients, traditionally done through arch expanders, or partial metal braces, before all permanent teeth have erupted, typically at ages seven through ten years. Invisalign First clear aligners are designed specifically to address a broad range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition and predictable dental arch expansion. |
| • | In October 2019, we launched the Invisalign Moderate Package for the treatment of mild to moderate malocclusion. The Invisalign Moderate treatment includes all the features of Invisalign treatment, plus additional features that address the orthodontic needs of teenage patients such as compliance indicators and compensation for tooth eruption. |
| • | New iTero Products and Technology Innovation. The iTero scanner is an important component to our customer experience and is central to a digital approach as well as overall customer utilization of Invisalign. |
| • | In April 2018, we expanded the iTero Element portfolio with the launch of the iTero Element 2 and the iTero Element Flex scanners, building on the existing high precision, full-color imaging and fast scan times of the iTero Element portfolio while streamlining orthodontic and restorative workflows. The next-generation iTero Element 2 is designed for greater performance with 2X faster start-up and 25% faster scan processing time compared to the iTero Element. The new iTero Element Flex wand-only configuration is a portable scanner for easy transport from office to office. |
As we continue to expand our global presence, we expect to seek regulatory approvals to offer our iTero portfolio products in more countries, thereby tapping potential growth opportunities in underserved markets
| • | In February 2019, we announced the launch of iTero Element 5D Imaging System for comprehensive, preventative and restorative oral care. The iTero Element 5D Imaging System provides a new comprehensive approach to clinical applications, workflows and user experience that expands the suite of existing high-precision, full color imaging and fast scan times of the iTero Element portfolio. The iTero Element 5D Imaging System is available in the majority of EMEA and select APAC countries. The iTero Element 5D Imaging System is pending regulatory approval and is not yet available in the U.S. or LATAM countries. |
| • | In June 2019, we announced the launch of iTero Element Foundation intraoral scanner with restorative software. The iTero Element Foundation extends Align’s portfolio of intraoral scanners with powerful 3D visualization to better meet the needs of doctors, labs and patients. The iTero Element Foundation is available in North America and will also be available in other select countries in 2020. |
We believe that over the longterm, clinical solutions and treatment tools will increase adoption of Invisalign and increase sales of our intraoral scanners; however, it is difficult to predict the rate of adoption which may vary by region and channel.
The use of iTero and other digital scanners for Invisalign case submission in place of PVS impressions continues to grow and remains a positive catalyst for Invisalign utilization. For the fourth quarter of 2019, total Invisalign cases submitted with a digital scanner in the Americas increased to 79.5%, up slightly from 78.8% in the third quarter of 2019. International scans increased to 64.7%, up from 62.6% in the third quarter of 2019. We believe that over the longterm, technology innovation and added features and functionality of our iTero scanners will increase adoption of Invisalign and increase sales of our intraoral scanners; however, it is difficult to predict the rate of adoption which may vary by region and channel.
| • | Invisalign Adoption. Our goal is to establish Invisalign as the treatment of choice for treating malocclusion ultimately driving increased product adoption and frequency of use by dental professionals, also known as “utilization rates.” Our annual utilization rates for the last three fiscal years are as follows: |

***** Invisalign utilization rates are calculated by the # of cases shipped divided by the # of doctors to whom cases were shipped. Our International region includes EMEA and APAC. LATAM is ex
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Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
In the normal course of business, we are exposed to foreign currency exchange rate and interest rate risks that could impact our financial position and results of operations.
Interest Rate Risk
Changes in interest rates could impact our anticipated interest income on our cash equivalents and investments in marketable securities. Our investments are fixed-rate short-term and long-term securities. Fixed-rate securities may have their fair market value adversely impacted due to a rise in interest rates, and, as a result, our future investment income may fall short of expectations due to changes in interest rates or we may suffer losses in principal if forced to sell securities which have declined in market value due to changes in interest rates. As of December 31, 2019, we had approximately $318.2 million invested in available-for-sale marketable securities. An immediate 10% change in interest rates would not have a material adverse impact on our future operating results and cash flows.
We do not enter into investments for trading or speculative purposes and have not used any derivative financial instruments to manage our interest rate risk exposure. Based on interest bearing liabilities we have as of December 31, 2019, we are not subject to risks from immediate interest rate increases.
Currency Rate Risk
As a result of our international business activities, our financial results could be affected by factors such as changes in foreign currency exchange rates or economic conditions in foreign markets, and there is no assurance that exchange rate fluctuations will not harm our business in the future. We generally sell our products in the local currency of the respective countries. This provides some natural hedging because most of the subsidiaries’ operating expenses are generally denominated in their local currencies. Regardless of this natural hedging, our results of operations may be adversely impacted by exchange rate fluctuations.
We enter into foreign currency forward contracts to minimize the short-term impact of foreign currency exchange rate fluctuations on cash and certain trade and intercompany receivables and payables. These forward contracts are not designated as hedging instruments and do not subject us to material balance sheet risk due to fluctuations in foreign currency exchange rates. The gains and losses on these forward contracts are intended to offset the gains and losses in the underlying foreign currency denominated monetary assets and liabilities being economically hedged. These instruments are marked to market through earnings every period and generally are one month in original maturity. We do not enter into foreign currency forward contracts for trading or speculative purposes. As our international operations grow, we will continue to reassess our approach to managing the risks relating to fluctuations in currency rates. It is difficult to predict the impact forward contracts could have on our results of operations. The fair value of foreign exchange forward contracts outstanding as of December 31, 2019 was not material.
Although we will continue to monitor our exposure to currency fluctuations, and, where appropriate, may use forward contracts to minimize the effect of these fluctuations, the impact of an aggregate change of 10% in foreign currency exchange rates relative to the U.S. dollar on our results of operations and financial position could be material.
Item 8. CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Quarterly Results of Operations
| Three Months Ended | |||||||||||||||||||||||||||||||
| 2019 | 2018 | ||||||||||||||||||||||||||||||
| December 31, 2019 | September 30, 2019 | June 30, 2019 | March 31, 2019 | December 31, 2018 | September 30, 2018 | June 30, 2018 | March 31, 2018 | ||||||||||||||||||||||||
| (in thousands, except per share data) (unaudited ) | |||||||||||||||||||||||||||||||
| Net revenues | $ | 649,787 | $ | 607,341 | $ | 600,697 | $ | 548,971 | $ | 534,020 | $ | 505,289 | $ | 490,259 | $ | 436,924 | |||||||||||||||
| Gross profit | 471,958 | 437,554 | 432,289 | 402,096 | 383,096 | 371,781 | 365,582 | 327,408 | |||||||||||||||||||||||
| Income from operations | 151,150 | 127,152 | 176,490 | 87,701 | 120,473 | 125,208 | 122,691 | 98,192 | |||||||||||||||||||||||
| Net income | 121,262 | 102,524 | 147,142 | 71,848 | 97,392 | 100,872 | 106,105 | 95,866 | |||||||||||||||||||||||
| Net income per share: | |||||||||||||||||||||||||||||||
| Basic | $ | 1.54 | $ | 1.29 | $ | 1.84 | $ | 0.90 | $ | 1.22 | $ | 1.26 | $ | 1.32 | $ | 1.20 | |||||||||||||||
| Diluted | $ | 1.53 | $ | 1.28 | $ | 1.83 | $ | 0.89 | $ | 1.20 | $ | 1.24 | $ | 1.30 | $ | 1.17 | |||||||||||||||
| Shares used in computing net income per share: | |||||||||||||||||||||||||||||||
| Basic | 78,578 | 79,332 | 79,943 | 79,860 | 79,891 | 80,111 | 80,216 | 80,036 | |||||||||||||||||||||||
| Diluted | 79,137 | 79,825 | 80,590 | 80,687 | 80,943 | 81,359 | 81,471 | 81,628 |
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
| Page | |
| Report of Management on Internal Control over Financial Reporting | 47 |
| Report of Independent Registered Public Accounting Firm | 48 |
| Consolidated Statements of Operations for the year ended December 31, 2019, 2018 and 2017 | 50 |
| Consolidated Statements of Comprehensive Income for the year ended December 31, 2019, 2018 and 2017 | 51 |
| Consolidated Balance Sheets as of December 31, 2019 and 2018 | 52 |
| Consolidated Statements of Stockholders’ Equity for the year ended December 31, 2019, 2018 and 2017 | 53 |
| Consolidated Statements of Cash Flows for the year ended December 31, 2019, 2018 and 2017 | 54 |
| Notes to Consolidated Financial Statements | 55 |
REPORT OF MANAGEMENT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Management of Align is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934. Our internal control over financial reporting is designed by, or under supervision of, our CEO and CFO, and effected by the board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Internal control over financial reporting includes those policies and procedures that:
| • | pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of Align; |
| • | provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of Align are being made only in accordance with authorizations of management and directors of Align; and |
| • | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of Align's assets that could have a material effect on the financial statements. |
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate.
Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2019. In making this assessment, management used the criteria set forth in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO").
Based on our assessment, management has concluded that, as of December 31, 2019, our internal control over financial reporting was effective based on criteria in Internal Control - Integrated Framework (2013) issued by the COSO.
The effectiveness of our internal control over financial reporting as of December 31, 2019 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which is included herein.
| /S/ JOSEPH M. HOGAN |
| Joseph M. Hogan |
| President and Chief Executive Officer |
| February 28, 2020 |
| /S/ JOHN F. MORICI |
| John F. Morici |
| Chief Financial Officer and Senior Vice President, Global Finance |
| February 28, 2020 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Align Technology, Inc.
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets of Align Technology, Inc. and its subsidiaries (the “Company”) as of December 31, 2019 and 2018, and the related consolidated statements of operations, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2019, including the related notes and financial statement schedule listed in the index appearing under item 15 (a)(2) (collectively referred to as the “consolidated financial statements”). We also have audited the Company's internal control over financial reporting as of December 31, 2019, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2019 in conformity with accounting
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Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None
Item 9A. CONTROLS AND PROCEDURES
Evaluation of disclosure controls and procedures.
Under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we have evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures are effective as of December 31, 2019 to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure, and that such information is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission rules and forms.
Management's annual report on internal control over financial reporting.
See “Report of Management on Internal Control over Financial Reporting” of this Annual Report on Form 10-K.
Changes in internal control over financial reporting.
There have been no changes in our internal control over financial reporting during the quarter ended December 31, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. OTHER INFORMATION
None.
PART III
Certain information required by Part III is omitted from this Form 10-K because we intend to file a definitive Proxy Statement for our 2020 Annual Meeting of Stockholders (the “Proxy Statement”) not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and certain information to be included therein is incorporated herein by reference.
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by Item 401 of Regulation S-K concerning our directors is incorporated by reference to the Proxy Statement under the section captioned “Election of Directors.” The information required by Item 401 of Regulation S-K concerning our executive officers is set forth in Item 1— “Business” of this Annual Report on Form 10-K. The information required by Item 405 of Regulation S-K is incorporated by reference to the section entitled “Section 16(a) Beneficial Ownership Reporting Compliance” contained in the Proxy Statement. The information required by Item 407(c)(3), 407(d)(4) and 407(d)(5) of Regulation S-K is incorporated by reference to the Proxy Statement under the section entitled “Corporate Governance”.
Code of Ethics
We have a code of ethics that applies to all of our employees, including our principal executive officer, principal financial officer and principal accounting officer. This code of ethics is posted on our Internet website. The Internet address for our website is www.aligntech.com, and the code of ethics may be found on the “Corporate Governance” section of our “Investor Relations” webpage.
We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of this code of ethics by posting such information on our website, at the address and location specified above, or as otherwise required by the NASDAQ Global Market.
Item 11. EXECUTIVE COMPENSATION
The information required by Item 402 of Regulation S-K is incorporated by reference to the Proxy Statement under the section captioned “Executive Compensation.” The information required by Items 407(e)(4) and (e)(5) is incorporated by reference to the Proxy Statement under the section captioned “Corporate Governance—Compensation Committee Interlocks and Insider Participation” and “Compensation Committee of the Board Report,” respectively.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by Item 403 of Regulation S-K is incorporated by reference to the Proxy Statement under the section captioned “Principal Stockholders”.
Equity Compensation Plan Information
The following table provides information as of December 31, 2019 about our common stock that may be issued upon the exercise of options and awards granted to employees, consultants or members of our Board of Directors under all existing equity compensation plans, including the 2005 Incentive Plan and the Employee Stock Purchase Plan ("ESPP"), each as amended, and certain individual arrangements (Refer to Note 11 "Stockholders’ Equity” of the Notes to Consolidated Financial Statements for a description of our equity compensation plans).
| Plan Category | Number of securities to be issued upon exercise of outstanding options and restricted stock units (a) | Weighted average exercise price of outstanding options (b) | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column(a)) | ||||||||
| Equity compensation plans approved by security holders | 939,539 | 1 | $ | — | 5,450,153 | 2, 3 | |||||
| Equity compensation plans not approved by security holders | — | — | — | ||||||||
| Total | 939,539 | $ | — | 5,450,153 |
| 1 | Includes 695,650 restricted stock units and 243,889 market-performance based restricted stock units at target, which have an exercise price of zero. |
| 2 | Includes 441,293 shares available for issuance under our ESPP. We are unable to ascertain with specificity the number of securities to be issued upon exercise of outstanding rights or the weighted average exercise price of outstanding rights under the ESPP. |
| 3 | Includes 653,854 of potentially issuable MSUs if performance targets are achieved at maximum payout. |
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by Item 404 and Item 407 of Regulation S-K is incorporated by reference to the Proxy Statement under the sections captioned “Certain Relationships and Related Party Transactions” and “Corporate Governance—Director Independence,” respectively.
Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by Item 9(e) of Schedule 14A of the Securities Act of 1934, as amended, is incorporated by reference to the Proxy Statement under the section captioned “Ratification of Appointment of Independent Registered Public Accountants.”
PART IV
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
| (a) | Financial Statements |
| 1. | Consolidated financial statements |
The following documents are filed as part of this Annual Report on Form 10-K:
| Report of Independent Registered Public Accounting Firm | 48 |
| Consolidated Statements of Operations for the year ended December 31, 2019, 2018 and 2017 | 50 |
| Consolidated Statements of Comprehensive Income for the year ended December 31, 2019, 2018 and 2017 | 51 |
| Consolidated Balance Sheets as of December 31, 2019 and 2018 | 52 |
| Consolidated Statements of Stockholders’ Equity for the year ended December 31, 2019, 2018 and 2017 | 53 |
| Consolidated Statements of Cash Flows for the year ended December 31, 2019, 2018 and 2017 | 54 |
| Notes to Consolidated Financial Statements | 55 |
| 2. | The following financial statement schedule is filed as part of this Annual Report on Form 10-K: |
Schedule II—Valuation and Qualifying Accounts and Reserves for the year ended December 31, 2019, 2018 and 2017
All other schedules have been omitted as they are not required, not applicable, or the required information is otherwise included.
SCHEDULE II: VALUATION AND QUALIFYING ACCOUNTS AND RESERVES
| Balance at Beginning of Period | Additions (Reductions) to Costs and Expenses | Write Offs | Balance at End of Period | ||||||||||||
| (in thousands) | |||||||||||||||
| Allowance for doubtful accounts: | |||||||||||||||
| Year Ended December 31, 2017 1 | $ | 2,946 | $ | 9,948 | $ | (7,080 | ) | $ | 5,814 | ||||||
| Year Ended December 31, 2018 | $ | 5,814 | $ | 12,321 | $ | (15,757 | ) | $ | 2,378 | ||||||
| Year Ended December 31, 2019 | $ | 2,378 | $ | 15,126 | $ | (10,748 | ) | $ | 6,756 | ||||||
| Valuation allowance for deferred tax assets: | |||||||||||||||
| Year Ended December 31, 2017 1 | $ | 256 | $ | 22 | $ | — | $ | 278 | |||||||
| Year Ended December 31, 2018 | $ | 278 | $ | (27 | ) | $ | — | $ | 251 | ||||||
| Year Ended December 31, 2019 | $ | 251 | $ | 835 | $ | — | $ | 1,086 |
| 1 | Balances have been recast to reflect the adoption of new revenue accounting standard (Refer to Note 1 "Summary of Significant Accounting Policies" of the Notes to Consolidated Financial Statements for details). |
| (b) | The following Exhibits are included in this Annual Report on Form 10-K: |
| † | Management contract or compensatory plan or arrangement filed as an Exhibit to this form pursuant to Items 14(a) and 14(c) of Form 10-K. |
Item 16. FORM 10-K SUMMARY
Not applicable.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on February 28, 2020.
| ALIGN TECHNOLOGY, INC. | |
| By: | /S/ JOSEPH M. HOGAN |
| Joseph M. Hogan | |
| President and Chief Executive Officer |
Each person whose signature appears below constitutes and appoints Joseph M. Hogan or John F. Morici, his or her attorney-in-fact, with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
| Signature | Title | Date | ||
| /S/ JOSEPH M. HOGAN | President and Chief Executive Officer (Principal Executive Officer) | February 28, 2020 | ||
| Joseph M. Hogan | ||||
| /S/ JOHN F. MORICI | Chief Financial Officer and Senior Vice President, Global Finance (Principal Financial Officer and Principal Accounting Officer) | February 28, 2020 | ||
| John F. Morici | ||||
| /S/ KEVIN J. DALLAS | Director | February 28, 2020 | ||
| Kevin J. Dallas | ||||
| /S/ JOSEPH LACOB | Director | February 28, 2020 | ||
| Joseph Lacob | ||||
| /S/ C. RAYMOND LARKIN, JR. | Director | February 28, 2020 | ||
| C. Raymond Larkin, Jr. | ||||
| /S/ GEORGE J. MORROW | Director | February 28, 2020 | ||
| George J. Morrow | ||||
| /S/ ANNE M. MYONG | Director | February 28, 2020 | ||
| Anne Myong | ||||
| /S/ THOMAS M. PRESCOTT | Director | February 28, 2020 | ||
| Thomas M. Prescott | ||||
| /S/ ANDREA L. SAIA | Director | February 28, 2020 | ||
| Andrea L. Saia | ||||
| /S/ GREG J. SANTORA | Director | February 28, 2020 | ||
| Greg J. Santora | ||||
| /S/ SUSAN E. SIEGEL | Director | February 28, 2020 | ||
| Susan E. Siegel | ||||
| /S/ WARREN S. THALER | Director | February 28, 2020 | ||
| Warren S. Thaler |