SANTA BARBARA, Calif.–(BUSINESS WIRE)–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, LP (“Oaktree”).
“After a competitive process, we couldn’t be happier 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 funding can fully fund our business to generate positive cash flow. This includes funding our potential market launches in the United States and China, launching our products around the world including MIA and Flora, and building our new facility that will allow us to meet more of the half of the current global market demand for breast products. implants.
“Establishment Labs has experienced tremendous growth since the company was founded over a decade ago and has cemented its position as a leader in the field of women’s health, with a particular focus on breast aesthetics and reconstruction. said Aman Kumar, co-portfolio manager of life sciences. Loan to Oaktree. “We are impressed with the long-term safety profile of Motiva implants, which are backed by the company’s state-of-the-art science and manufacturing processes. Oaktree is very excited to partner with the company in its next phase of anticipated growth as it seeks to enter the US market, while continuing to expand its product offering to women around the world.
The Term Loan Facility will be available to Establishment Labs on 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 to maturity. Proceeds received from the first tranche of the facility will be used to repay the company’s current term loan, to fund the construction of the new Sulayom 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 increase to 8.25% when the financing conditions of the fourth tranche are met. Establishment Labs may elect to PIK up to two-thirds of the cash interest payments for the first 24 months of the term of the loan, resulting in a minimum initial 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 being available upon completion of certain commercial and regulatory milestones:
$25 million Tranche B available by September 30, 2023 and on year-over-year net product sales exceeding $145 million
$25 million Tranche C available by March 31, 2024, and over twelve consecutive months of net product sales exceeding $185 million or upon FDA approval of certain Motiva implants for use in the United States, according to the first contingency
$25 million Tranche D available by December 31, 2024, and both last twelve months of net product sales exceeding $225 million and FDA approval of select Motiva implants for use in the States -United
A Form 8-K outlining the complete terms of the credit facility will be filed with the Securities and Exchange Commission.
Cowen acted as exclusive financial advisor to Establishment Labs.
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-driven, risk-controlled approach for investments in credit, private equity, real estate assets and listed shares. The company has more than 1,000 employees and offices in 20 cities around the world. For more information, please visit the Oaktree website at http://www.oaktreecapital.com/.
About Institutional Laboratories
Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving the health and well-being of women. The initial focus of the company is breast health, primarily aesthetics and breast reconstruction. Establishment Labs offers a range of advanced silicone gel-filled breast implants, branded as Motiva Implants® which include a number of innovative and patented features designed to deliver better aesthetic and clinical results. 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 in 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 started 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 comply with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our website for more information at www.establishmentlabs.com.
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 searching for words such as “approaches”, “believes”, “expects”, “anticipates”, “estimates”, “intends to “, “plans”, “intends”, “” “would”, “will”, “could” or other similar expressions in this press release. Any statement that refers to projections of our financial performance or future operating conditions, anticipated trends in our business, our objectives, strategies, priorities and plans, including the development and commercialization of related products and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to business performance are forward-looking statements.We claim the safe harbor protection contained in the Private Securities Litigation Reform Act of 1995. We remind investors that all forward-looking statements set forth in this report, or which we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on information currently available at the time such statements are made. . These statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties and factors beyond our control. Although we believe our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. Therefore, our actual future results and 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 the forward-looking statements include risks and uncertainties relating to: our ability to develop, research and successfully obtain, timely and cost-effectively gain regulatory approval to and market 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 develop and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid significant disruption to 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, the risks and uncertainties discussed in the Company’s Annual Report on Form 10-K filed March 1, 2022, reports quarterly statements on Form 10-Q, and other documents filed by the Company with the Securities and Exchange Commission. The risks included in these materials are not exhaustive and additional factors could adversely affect our business and financial performance. We operate in a highly competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all of these risk factors, or to assess the impact of all of these risk factors on our business or the extent to which any one factor, or a combination of factors, may cause actual results to differ materially from those contained in the forward-looking statements. We assume no obligation to update forward-looking statements. Accordingly, investors should exercise caution when 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.