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 Presentation Materials
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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