Form 8-K - Current report

Building B15 and 25Coyol Free ZoneAlajuelaCosta RicaNASDAQ5062434 24000001688757false00016887572024-11-072024-11-07

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

November 7, 2024
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

98-1436377

(State or other jurisdiction of incorporation or organization)

(Commission File No.)

(I.R.S. Employer Identification Number)

Building B15 and 25 Coyol Free Zone Alajuela Costa Rica

(Address of principal executive offices) (Zip Code)

[phone]

(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. ☐

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Item 7.01 Regulation FD Disclosure.

On November 7, 2024, Establishment Labs Holdings Inc. (the “Company”) issued a press release announcing a registered direct offering of common shares and pre-funded warrants to purchase common shares. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference.

On November 7, 2024, the Company announced that it expects revenue for fiscal year 2024 to be $165 million to $168 million. For budgeting purposes, the Company expects non-U.S. fiscal year 2025 revenue to grow mid-single digits from fiscal year 2024 and U.S. fiscal year 2025 revenue to exceed $35 million.

On November 7, 2024, the Company also entered into the Third Amendment to Credit Agreement and Guaranty with Oaktree Fund Administration, LLC, as administrative agent, and the other parties thereto (the “Amendment”), which amends the terms of that certain Credit Agreement and Guaranty, dated as of April 26, 2022 (as amended, the “Agreement”). The Amendment extends the Commitment Termination Date (as defined in the Agreement) with respect to the commitments applicable to the Tranche D Term Loans, from June 30, 2025 to December 31, 2025 and modifies the milestone triggering the availability of the Tranche D Term Loans to provide for availability of the Tranche D Term Loans upon achieving trailing twelve month gross sales of $195 million, including trailing twelve month gross sales of $30 million in the U.S. with respect to Motiva Implants and the Motiva Flora Tissue Expander product.

The information in Item 7.01 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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 (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “intends to,” “would,” “will,” “may” or other similar expressions in this press release. Any statements that refer to the anticipated terms of the offering, projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as updated in the Company’s Quarterly Report on Form 10-Q

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for the quarter ended September 30, 2024 that will be filed with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.			Description
99.1			Press Release issued by Establishment Labs Holdings Inc. on November 7, 2024
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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.

ESTABLISHMENT LABS HOLDINGS INC.

Dated:

November 7, 2024

By:

/s/ Rajbir S. Denhoy

Name:

Rajbir S. Denhoy

Title:

Chief Financial Officer

						EXHIBIT 99.1

PRESS RELEASE			Investor/Media Contact: Raj Denhoy 415 828-1044 [e-mail]

Establishment Labs Announces $50 million Registered Direct Offering

NEW YORK, NY, November 7, 2024 -- Establishment Labs Holdings Inc. (Nasdaq: ESTA) (the “Company”), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced that it has entered into a securities purchase agreement (the “Purchase Agreement”) with select purchasers for the purchase of 765,696 common shares and pre-funded warrants to purchase up to 328,161 common shares in a registered direct offering for aggregate gross proceeds of approximately $50 million.

The purchase price for the common shares is $45.71 per share and the purchase price for the pre-funded warrants is $45.709 per warrant, which represents the per share purchase price for the common shares less the $0.001 exercise price for the pre-funded warrant. The Company has also agreed to issue up to 76,569 additional common shares and additional pre-funded warrants to purchase up to 32,815 common shares, which in the aggregate equals ten percent of the aggregate number of common shares and pre-funded warrants to purchase common shares being sold in this offering. These additional securities are issuable for no additional consideration if the average closing price of the Company’s common shares on Nasdaq during the period from January 1, 2025 to August 31, 2025 does not exceed $45.71, which is the price per common share sold in this offering. The offering is expected to close on or about November 12, 2024, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds from this offering, together with its existing cash, for general corporate purposes, including sales and marketing, research and development activities, general and administrative matters, working capital and capital expenditures.

The common shares, pre-funded warrants and common shares issuable upon the exercise of the pre-funded warrants were offered pursuant to the Company’s automatically effective shelf registration statement on Form S-3ASR (File No. 333-271418) filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 24, 2023. A final prospectus supplement relating to the offering will be filed with the SEC and available on the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

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About Establishment Labs

Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The nearly four million Motiva ® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora ® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program.

Forward-Looking Statements

This press release 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 (the “Exchange Act”). All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements that relate to the Company’s registered direct offering and statements containing the words “plans,” “expects,” “believes,” “strategy,” “opportunity,” “anticipates,” “outlook,” “designed,” or other forms of these words or similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the securities offering discussed above will be completed on the terms described. Completion of the offering is subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, failure of customary closing conditions relating to the offering and other risks and uncertainties discussed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as updated in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 that will be filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

Cover	Nov. 07, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Nov. 07, 2024
Entity Registrant Name	Establishment Labs Holdings Inc.
Entity Incorporation, State or Country Code	D8
Entity File Number	001-38593
Entity Address, Address Line One	Building B15 and 25
Entity Address, Address Line Two	Coyol Free Zone
Entity Address, City or Town	Alajuela
Entity Address, Country	CR
Country Region	506
City Area Code	24
Local Phone Number	34 2400
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Shares, No Par Value
Trading Symbol	ESTA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001688757
Amendment Flag	false
Entity Tax Identification Number	98-1436377

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