8-K

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

Establishment Labs Holdings Inc.

(Exact name of registrant as specified in its charter)

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:

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

d) Election of Director; Appointment of Committee Members

On July 13, 2021, the Board of Directors (the “Board”) of Establishment Labs Holdings Inc. (the “Company”) appointed Ms. Ann Custin and Mr. Bryan Slotkin to the Board, effective immediately. Ms. Custin and Mr. Slotkin will both serve as Class III directors, with their respective terms expiring at the annual meeting of stockholders to be held in 2024 when they are both expected to stand for election by a vote of the Company’s stockholders. In addition, the Board appointed Ms. Custin as a member of the Board’s Audit Committee and Compensation Committee and Mr. Slotkin as a member of the Audit Committee and the Nominating and Corporate Governance Committee, both effective immediately.

Ms. Custin served as Chief Financial Officer and on the board of directors of Siemens Medical Solutions Inc. from February 2012 to December 2019, retiring following such tenure. Ms. Custin previously served as Chief Operating and Financial Officer of Scient’x and President and CEO USA of Drager Medical Systems. Ms. Custin holds a B.A. in Accounting from Queens College, CUNY.

Mr. Slotkin is a partner with PJT Partners, a global advisory-focused investment bank, from June 2018 to the present. Mr. Slotkin was a Partner with Discovery Land Company from July 2017 to June 2018 and a Managing Director with Goldman Sachs from May 2007 to June 2017. Mr. Slotkin holds a B.S. in Finance from Rutgers College, and a J.D. and M.B.A. from George Washington University.

The Board has nominated Ms. Custin for election as a director because of her extensive expertise in business and experience with large medical device companies. The Board has determined that Ms. Custin qualifies as an Audit Committee Financial Expert due to her prior experience, including her previous roles as Chief Financial Officer of the various enterprises referenced above.

The Board has nominated Mr. Slotkin for election as a director because of his extensive expertise in business and experience advising public company boards. The Board has determined that Mr. Slotkin qualifies as an Audit Committee Financial Expert due to his prior experience as an investment banker advising companies on complex financial transactions.

In connection with the appointment of Ms. Custin and Mr. Slotkin to the Board on July 13, 2021, they were each granted a stock option for 12,000 of the Company’s Common Shares. One-third of the shares subject to the option vest on July 13, 2022 and each one-year anniversary thereafter, subject to their continuing as a service provider to the Company through each such date, respectively. The option award is subject to the terms and conditions of the Company’s 2018 Equity Incentive Plan and its related option agreement. Ms. Custin and Mr. Slotkin, as directors, will both participate in the compensation program applicable to all non-employee directors, which is described under the heading “Non-Employee Director Compensation” in the Company’s Definitive Proxy Statement relating to the Annual Meeting of Stockholders filed with the Securities and Exchange Commission on April 14, 2021.

Ms. Custin and Mr. Slotkin also executed the Company’s standard form of indemnification agreement, a copy of which has been filed as Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-225791) filed with the Securities and Exchange Commission on June 21, 2018.

There are no arrangements or understandings between Ms. Custin and any other persons pursuant to which Ms. Custin elected as a director. There are no arrangements or understandings between Mr. Slotkin and any other persons pursuant to which Mr. Slotkin elected as a director.

Following the appointments of Ms. Custin to the Audit Committee and Compensation Committee and Mr. Slotkin to the Audit Committee and the Nominating and Corporate Governance Committee, the composition of the committees are as follows. The Nominating and Corporate Governance Committee shall consist of Lisa Gersh,

Dennis Condon, and Mr. Slotkin, with Ms. Gersh serving as chair. The Audit Committee shall consist Lisa Colleran, Ms. Gersh, Ed Shutter, Ms. Custin, and Mr. Slotkin, with Ms. Colleran serving as chair. The Compensation Committee shall consist of Mr. Shutter, Mr. Condon, Ms. Colleran, and Ms. Custin, with Mr. Sutter serving as chair. The Board has determined that all of the members of the Audit Committee, the Compensation Committee, and the Nominating and Corporate Governance Committee currently satisfy the independence requirements and other established criteria of The NASDAQ Stock Market LLC.

On July 15, 2021, the Company issued a press release announcing the appointment of Ms. Custin and Mr. Slotkin to the Board. The press release is attached hereto as Exhibit 99.1.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

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.

Document

EXHIBIT 99.1

Establishment Labs Announces Appointment of Ann Custin and Bryan Slotkin to Board of Directors

SANTA BARBARA, Calif., July 15, 2021 -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced the appointment of Ann Custin and Bryan Slotkin to its Board of Directors, effective immediately.

“We are delighted to have these two very accomplished individuals join the Board of Establishment Labs,” said Juan José Chacón-Quirós, Founder and CEO of Establishment Labs. “Good governance is essential to our mission of improving women’s health. Their unique perspectives will be critical as we continue to reshape and expand our industry by offering differentiated technologies that create value for all stakeholders.”

Ms. Custin was most recently with Siemens Healthineers, where she was Board Director and Chief Financial Officer of Siemens Medial Solutions; she retired from the company in December 2019. Ms. Custin previously served as Chief Operating and Financial Officer of Scient’x and President and CEO USA of Drager Medical Systems.

“Establishment Labs has proven that true innovation coupled with the guiding principle of improving women’s health can be transformative,” said Ann Custin. “We are bringing a compelling combination to the market, and I am excited to join the Board as we prepare to enter new geographies and launch exciting new products.”

Mr. Slotkin is a Partner with PJT Partners, a global advisory-focused investment bank. He is responsible for the firm's global financial sponsor relationships and is a strategic advisor to public and private companies in the real estate, gaming, leisure, consumer, and healthcare sectors. Mr. Slotkin was previously a Managing Director with Goldman Sachs.

“I have been fortunate to know Establishment Labs for many years and to watch the company’s growth and maturation into an industry leader,” said Bryan Slotkin. “The team has created a tremendous amount of value, but there is still much more to come. I look forward to working with Juan José and the Board as we continue on our mission to positively impact the lives of women around the world.”

About Establishment Labs

Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in more than 80 countries through exclusive distributors or the Company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant® clinical trial in the United States in April 2018. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes the Divina® 3D Simulation System and other products and services. Please visit our website for additional information at www.establishmentlabs.com.

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”). 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. 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. Any statements that refer to 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 that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the company’s annual report on Form 10-K filed on March 15, 2021, quarterly reports on Form 10-Q, and other filings made by the company 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.