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ALGNAlign Technology

Health care · Medical Devices · Nasdaq
Employees
20,290
Headquarters
Tempe, AZ
CEO
Joseph Hogan
Next results
around Feb 3, 2027
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When the SEC's staff reviews a filing, it writes to the company with numbered questions, and the company answers each one in a letter. SEC publishes the exchange once the review is over, at least 20 business days later. Below: what the staff asked ALGN, and the company's answer to each question, quoted from the letters. A question is not an accusation; most reviews end with the company adding detail to its next filing.

Form 10-K for the Fiscal Year Ended December 31, 2021

2022-03-31 to 2022-06-09 · 2 questions · 2 letters from the SEC, 4 from the company
Review closed 2022-06-09
Revenue
Consolidated Financial Statements · Revenue Recognition, page 68
SEC asked
You disclose that determining the standalone selling price, allocation of consideration from the contract to the individual performance obligations and the appropriate timing of revenue recognition is the result of significant qualitative and quantitative judgments. You also identify a variety of factors that you consider, which may vary over time.
Rest of the question

Please tell us how your disclosure is consistent with ASC 606-10-50-1(b) as it relates to the disclosure of quantitative information related to your significant judgments and changes in judgments. As part of your response, please address how your disclosure meets the objective of the disclosure requirements of Topic 606.

ALGN answered
Align Technology Inc. (“Align”) acknowledges receipt of your comment letter dated March 31, 2022 (the "Comment letter") with respect to the above-referenced filing. As discussed with the Staff on April 12, 2022, the Company respectfully requests an extension to respond to the Comment Letter in order to provide sufficient time for the Company to prepare the necessary response. The Company is committed to responding to the Comment Letter promptly and intends to provide a response to the Staff no later than April 22, 2022. We are grateful for the Staff's assistance in this matter.
Rest of the answer

In the meantime, if the Staff has any questions, please do not hesitate to contact me at (408) 470-1006.

Yours truly,

/s/ John F. Morici

John F. Morici

Chief Financial Officer and Executive Vice President, Global Finance

Read in the reply ↗
In its next report

First report after the company's reply of 2022-04-12: 10-Q filed 2022-05-05 ↗, against the 10-Q filed 2021-11-02 ↗.

Tickdelta does not hold the text of both reports, so they are not compared here.

Consolidated Financial Statements · Revenue Recognition, page 68
SEC asked
We have reviewed your response to prior comment 1 and note that you estimate usage, which requires significant judgment. For each of the periods presented, please tell us your estimated usage rates. If multiple types of estimated usage rates are used, please explain how these were determined. In addition, tell us the approximate impact to revenue from any period over period changes in estimated usage rates.
ALGN answered
Align Technology Inc. (“Align”) acknowledges receipt of your comment letter dated April 29, 2022 (the "Comment letter") with respect to the above-referenced filing. As discussed with the Staff on May 11, 2022, the Company is grateful for the Staff's extension to respond to the Comment letter by May 27, 2022, to provide sufficient time for the Company to prepare the necessary response. In the meantime, if the Staff has any questions, please do not hesitate to contact me at (408) 470-1006.

Yours truly,

/s/ John F. Morici

John F.
Rest of the answer

Morici

Chief Financial Officer and Executive Vice President, Global Finance

Read in the reply ↗
In its next report

First report after the company's reply of 2022-05-11: 10-Q filed 2022-08-04 ↗, against the 10-Q filed 2021-11-02 ↗.

Tickdelta does not hold the text of both reports, so they are not compared here.

Also in this review: company letter, 2022-04-21, company letter, 2022-05-25, closing letter, 2022-06-09

Form 10-K

2016-04-29 to 2016-05-16 · 1 question · 1 letter from the SEC, 1 from the company
Review closed 2016-05-16
Intellectual Property, page 10
SEC asked
We note your disclosure that the expiration of some of your key patents beginning in 2017 may result in additional competition. Please ensure that you future filings, as appropriate, disclose the effects of those patents on your business and clarify how the expiration of those patents may result in additional competition. For example, do you expect more competitors to enter the market?
Rest of the question

Do you expect existing competitors to begin offering products more similar to yours?

ALGN answered
Align acknowledges the Staff’s comment and will, in future filings as appropriate, provide additional disclosures on the effects of expiration of key patents on Align’s business and how the expiration may result in additional competition.

Align respectfully advises the Staff that the following risk factor will be revised in the Form 10-Q for the period ending March 31, 2016, and in future filings, as appropriate:

Competition in the markets for our products is intense and we expect aggressive competition from existing competitors and other companies that may introduce new technologies in the
Rest of the answer

future.

Currently, our products compete directly against products manufactured and distributed by various companies, both within and outside the U.S. Many of these manufacturers, including Danaher Corporation, 3M, Sirona Dental Systems,

Inc. and Dentsply International, have substantially greater financial resources and manufacturing and marketing experience than we do and may, in the future, attempt to develop an orthodontic system similar to ours or combine technologies that make our product economically unattractive. The expiration of certain key patents commencing in 2017 owned by us may result in additional competition. Existing competitors may begin offering products more similar to ours. We may face more intense competition if new entrants to the clear aligner market are significantly larger than we are with greater resources and the ability to leverage their existing channels in the dental market to compete directly with us. In addition, corresponding foreign patents will start to expire in 2018, which may lead to increased competition in some of the markets outside the U.S. Large consumer product companies may also enter the orthodontic supply market. Furthermore, we may face competition in the future from new companies that may introduce new technologies. We may be unable to compete with these competitors and one or more of these competitors may render our technology obsolete or economically unattractive. If we are unable to compete effectively with existing products or respond effectively to any products developed by new or existing competitors, our business could be harmed. Increased competition has resulted in the past and may in the future result in volume discounting and price reductions, reduced gross margins, reduced profitability and loss of market share, and reduce dental professionals’ efforts and commitment to expand their use of our products, any of which could have a material adverse effect on our net revenues, volume growth, net income and stock price. We cannot assure you that we will be able to compete successfully against our current or future competitors or that competitive pressures will not have a material adverse effect on our business, results of operations and financial condition.

In the future filings, Align will continue to review and assess the quality of its disclosures to ensure that it continues to provide its reader with relevant information to understand the patent expiration.

Align’s Acknowledgment

As requested by the Staff, Align acknowledges that:

•

Align is responsible for the adequacy and accuracy of the disclosures in its filings;

Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and

Align may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

If the Staff would like any additional information or has any further questions, please do not hesitate to contact me at (408) 470-1114.

Read in the reply ↗
In its next report

First report after the company's reply of 2016-05-05: 10-Q filed 2016-08-04 ↗, against the 10-Q filed 2015-10-29 ↗.

Tickdelta does not hold the text of both reports, so they are not compared here.

Also in this review: closing letter, 2016-05-16

1 other letter: notices that a filing will not be reviewed, requests to declare a registration effective, and the like
  • 2013-08-29 · SEC: review completed · Align Technology, Inc. · Form 10-K for the Fiscal Year Ended December 31, 2012 · Filed...

From the SEC's correspondence on EDGAR: staff letters (form UPLOAD) and company letters (form CORRESP), 11 letters filed since 2013-08-29. Questions and answers are matched by their numbers; topics come from words in each question. The reports are compared word for word (same form, before the first SEC letter against the first report after the company's reply). No AI.

Work on ALGN in a spreadsheet: Excel workbook (a sheet per section, ten years by column, charts, links to the filings) · CSV. For a Google Sheet that stays up to date, paste =IMPORTDATA("https://tickdelta.com/company/ALGN/export.csv") into a cell.