UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
| | |
| January 11, 2023 |
| Date of Report (date of earliest event reported) |
Establishment Labs Holdings Inc.
(Exact name of registrant as specified in its charter)
| | | | | | | | | | | | | | | | | | | | |
| British Virgin Islands | 001-38593 | Not applicable |
(State or other jurisdiction of
incorporation or organization) | (Commission File No.)
| (I.R.S. Employer
Identification Number) |
Buiding B15 and 25 Coyol Free Zone Alajuela Costa Rica |
| (Address of principal executive offices) (Zip Code) |
| +506 2434 2400 | |
| (Registrant’s telephone number, including area code) | |
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
| Title of each class | Trading symbol | Name of each exchange on which registered |
| Common Shares, No Par Value | ESTA | The NASDAQ Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2) of this chapter.
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 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
Establishment Labs Holdings Inc. (the “Company”) is furnishing presentation materials included as Exhibit 99.1 to this report pursuant to Item 7.01 of Form 8-K.
The Company’s Chief Executive Officer Juan Jose Chacon-Quiros will present at the annual J.P. Morgan Healthcare Conference on January 12, 2023. A copy of the presentation materials is attached. In his prepared remarks, Mr. Chacon-Quiros will comment that before the end of 2022, the Company notified the Food and Drug Administration (“FDA”) that it was ready to submit Module 4 of the pre-market approval (“PMA”) to commercialize Motiva Implants in the U.S. The Company and the FDA have been working collaboratively on the optimal timing to submit the final module so that the full submission can be reviewed most efficiently. The Company expects to file Module 4 during the first quarter of 2023. Mr. Chacon-Quiros will also comment that the Company expects to achieve $500 million in annual revenue in fiscal year 2026.
The Company is not undertaking to update this presentation. The information in this report (including Exhibit 99.1) is being furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. This report will not be deemed an admission as to the materiality of any information herein (including Exhibit 99.1).
Special Note Regarding Forward-Looking Statements
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934, as amended or the Exchange Act. These estimates should not be viewed as a substitute for our full interim or annual financial statements prepared in accordance with U.S. generally accepted accounting principles. Accordingly, you should not place undue reliance on this preliminary data. The preliminary financial data has been prepared by, and is the responsibility of, our management. Marcum LLP, our independent registered public accounting firm, has not audited, reviewed, compiled or performed any procedures with respect to the accompanying preliminary financial data. Accordingly, Marcum LLP does not express an opinion or any other form of assurance with respect thereto.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| | | | | |
| Exhibit No. | Description |
| 99.1 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
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| | | | ESTABLISHMENT LABS HOLDINGS INC. |
| | | | |
| Dated: | January 11, 2023 | | By: | /s/ Rajbir S. Denhoy |
| | | Name: | Rajbir S. Denhoy |
| | | Title: | Chief Financial Officer |
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