- Senior secured term loan of up to $225 million, with a $150 million initial draw and $75 million available on achievement of commercial and regulatory milestones

- Facility provides non-dilutive capital to fund Establishment Labs to cash flow positive under current estimates

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 that it has entered into a $225 million term loan financing facility with funds managed by Oaktree Capital Management, L.P. (“Oaktree”).

“After a competitive process, we could not be more pleased to enter into this long-term strategic partnership with Oaktree,” said Raj Denhoy, Chief Financial Officer of Establishment Labs. “This is a pivotal moment for Establishment Labs, as this financing can fully fund our business to cash flow positive. This includes financing our prospective market launches in the United States and China, our product launches around the world — most notably MIA and Flora — and the construction of our new facility that will allow us to meet more than half the current world market’s demand for breast implants.”

“Establishment Labs has grown tremendously since the company’s founding over a decade ago and has cemented its position as a leader in the women’s health space, with a deep focus on breast aesthetics and reconstruction,” said Aman Kumar, Co-Portfolio Manager of Life Sciences Lending at Oaktree. “We are impressed with the long-term real-world safety profile of the Motiva implants, which are backed by the company’s state-of-the-art manufacturing and scientific processes. Oaktree is very excited to partner with the company during its next phase of anticipated growth as it seeks to enter the United States market, while continuing to expand its product offerings to women worldwide.”

The term loan facility will be available to Establishment Labs under the following terms:

• A senior secured term loan of up to $225 million. The facility will mature in five years from funding and is interest-only through to maturity. Proceeds received from the first tranche of the facility will be used to retire the company’s current term loan, to fund construction of the new Sulàyöm Innovation Campus in Costa Rica, and for general corporate purposes and working capital.

• Interest will accrue at a fixed rate of 9.00% per annum and will step down to 8.25% upon the funding conditions for the fourth tranche being met. Establishment Labs can elect to PIK up to two-thirds of cash interest payments for the first 24 months of the loan term, resulting in a minimum initial cash interest rate of 3.00%.

• The first tranche (Tranche A) of $150 million will be drawn immediately, with the remaining three tranches of $25 million each available upon the achievement of certain commercial and regulatory milestones:
  
  
  
  
  • Tranche B of $25 million available before September 30, 2023, and upon trailing twelve-month product net sales exceeding $145 million
  • Tranche C of $25 million available before March 31, 2024, and upon either trailing twelve-month product net sales exceeding $185 million or upon FDA approval of certain Motiva implants for use in the U.S., whichever is achieved earlier
  • Tranche D of $25 million available before December 31, 2024, and upon both trailing twelve-month product net sales exceeding $225 million and FDA approval of certain Motiva implants for use in the U.S.

A Form 8-K outlining the full terms of the credit facility will be filed with the Securities and Exchange Commission.

Cowen acted as exclusive financial advisor to Establishment Labs.

About Oaktree

Oaktree is a leader among global investment managers specializing in alternative investments, with $166 billion in assets under management as of December 31, 2021. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in credit, private equity, real assets and listed equities. The firm has over 1,000 employees and offices in 20 cities worldwide. For additional information, please visit Oaktree’s website at http://www.oaktreecapital.com/.

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness. The company’s initial focus is breast health, principally breast aesthetics and reconstruction. Establishment Labs offers a portfolio of advanced silicone gel-filled breast implants, branded as Motiva Implants^® that include a number of innovative and patented features designed to deliver improved aesthetic and clinical outcomes. Since commercial launch in 2010, approximately 2.0 million Motiva Implants^® have been delivered to plastic surgeons in over 80 countries. The company also offers or has under development a number of related products and technologies, including the Motiva Flora^® tissue expander and Motiva MIA^®, the company’s minimally invasive breast enhancement offering. In 2018, Establishment Labs received an investigational device exemption (IDE) from the FDA for the Motiva Implant^® and began a clinical trial to support regulatory approval in the United States. Motiva Implants^® are manufactured at the company’s two facilities in Costa Rica, which are compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. 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. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, 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 annual report on Form 10-K filed on March 1, 2022, 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.

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