8-K
ESTABLISHMENT LABS HOLDINGS INC. (ESTA)
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 9, 2021 |
|---|
| 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 | Not applicable | |
|---|---|---|---|
| (State or other jurisdiction of <br>incorporation or organization) | (Commission File No.) | (I.R.S. Employer <br>Identification Number) | |
| Buiding B15 and 25<br><br>Coyol Free Zone<br><br>Alajuela<br><br>Costa Rica | |||
| (Address of principal executive offices) (Zip Code) | |||
| +506 2434 2400 | |||
| (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. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 9, 2021, Establishment Labs Holdings Inc. (the “Company”) issued a press release announcing the Company’s financial results for the three and nine months ended September 30, 2021 and recent corporate highlights. A copy of the press release is furnished herewith as Exhibit 99.1.*
* The information in Item 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release of Establishment Labs Holdings Inc. dated November 9, 2021. |
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 9, 2021 | By: | /s/ Rajbir S. Denhoy |
| Name: | Rajbir S. Denhoy | ||
| Title: | Interim Chief Financial Officer |
Document
| Coyol Free Zone & Business Park Building, 4th Street, Building B-15,<br><br>Alajuela, COSTA RICA | 1187 Coast Village Road, Suite 1-402,<br><br>Santa Barbara CA 93108, USA |
|---|---|
| EXHIBIT 99.1 | |
| PRESS RELEASE | Investor/Media Contact:<br><br>Raj Denhoy<br><br>415 828-1044<br><br>rdenhoy@establishmentlabs.com |
| --- | --- |
Establishment Labs Reports Third Quarter 2021 Financial Results and Raises Full Year Guidance
SANTA BARBARA, Calif., Nov 9, 2021 -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced its financial results for the third quarter ended September 30, 2021 and provided updated 2021 guidance.
Third Quarter Highlights and Outlook
•Third quarter worldwide sales of $29.0 million, an increase of 27.6% year-over-year.
•2021 guidance increased to a new range of $124 million to $128 million, an increase of 46% to 51% over 2020; previous 2021 guidance range was $122 million to $126 million.
•Gross profit for the third quarter was 67.6% of revenue, compared to 66.6% of revenue for the same period in 2020.
•Third quarter operating expenses of $28.7 million, an increase of 61.6% compared to the third quarter of 2020 as spending returned to more normalized levels following the global disruption in 2020.
•Cash balance of $64.6 million as of September 30, 2021.
•Launched Motiva Flora® tissue expander in Europe and CE mark countries at London Breast Meeting.
•Motiva JOY® and Motiva MIA® development and commercialization plans progressing as planned.
•Timelines for US and China market entry remain unchanged.
“The momentum we have seen across all areas of our business in 2021 continued in the third quarter,” said Juan José Chacón-Quirós, Chief Executive Officer. “Third quarter revenue of $29.0 million was up 27.6% from the third quarter of 2020 and we are raising full year 2021 revenue guidance to a new range of $124 million to $128 million.”
“Our strong financial results are being matched by the significant progress we are making across a number of programs and initiatives,” Mr. Chacón-Quirós continued. "We launched our Motiva Flora tissue expander at the London Breast Meeting during the third quarter. This is an important step in our Aesthetic BreastRecon® program, where we are working to expand awareness and access of post-mastectomy reconstruction while offering the tools and techniques that allow women to receive reconstructive surgeries that achieve the aesthetic ideals to which they aspire."
“In addition, our JOY and MIA programs are progressing. These advances are not only opening up significant new markets, they are also allowing us to have a more direct relationship with women on their journey with Motiva. Our regulatory and commercial timelines to begin selling Motiva implants in the U.S. and Chinese markets are also progressing as planned. We remain on a clear path to becoming the leader in breast aesthetics and reconstruction, and to expand these markets as we offer safe, differentiated, and accessible solutions to women.”
Third Quarter 2021 Financial Results
Total revenue for the quarter ended September 30, 2021 was $29.0 million compared to $22.8 million for the same period in 2020. Direct sales comprised approximately 41% of total sales, while distributor sales made up the balance.
Gross profit for the third quarter was $19.6 million, or 67.6% of revenue, compared to $15.1 million, or 66.6% of revenue, for the same period in 2020. The change in gross margin was the result of regional mix returning to more normalized levels as well as increased production volumes.
Total operating expenses for the third quarter were $28.7 million, an increase of $10.9 million compared to $17.7 million in the third quarter of 2020.
SG&A expenses for the third quarter increased approximately $9.8 million to $24.8 million compared to $15.0 million in the third quarter of 2020. The increase resulted from more normalized business practices following disruption from the global pandemic in the year ago period.
R&D expenses increased approximately $1.2 million to $3.9 million in the third quarter compared to $2.7 million for the same quarter a year ago. The majority of the increase was due to a normalization of spending levels and the timing of clinical trial and other expenses.
Net loss from operations for the third quarter was $9.0 million compared to a net loss of $2.6 million in the year ago period.
The Company’s cash balance on September 30, 2021 was $64.6 million. Cash decreased $19.9 million from December 31, 2020 and $12.2 million from the prior quarter, primarily as the result of operating losses and changes in working capital.
Conference Call and Webcast Information
Establishment Labs will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss its financial results. The conference call can be accessed by dialing (877) 407-8037 (U.S. and Canada) or (201) 689-8037 (international) and using conference ID number 13723217. In addition, the live and archived webcast will be available on the Investor Relations section of the Company's website at www.establishmentlabs.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, more than 1.8 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 procedure. 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 quarterly report on Form 10-Q filed on July 30, 2021, 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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ESTABLISHMENT LABS HOLDINGS INC.
Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
| Three Months Ended<br>September 30, | Nine Months Ended<br>September 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| Revenue | $ | 29,039 | $ | 22,758 | $ | 91,369 | $ | 57,713 |
| Cost of revenue | 9,419 | 7,612 | 30,191 | 19,855 | ||||
| Gross profit | 19,620 | 15,146 | 61,178 | 37,858 | ||||
| Operating expenses: | ||||||||
| Sales, general and administrative | 24,780 | 15,008 | 64,671 | 48,430 | ||||
| Research and development | 3,884 | 2,729 | 12,281 | 9,327 | ||||
| Total operating expenses | 28,664 | 17,737 | 76,952 | 57,757 | ||||
| Loss from operations | (9,044) | (2,591) | (15,774) | (19,899) | ||||
| Interest income | 7 | 2 | 15 | 12 | ||||
| Interest expense | (2,293) | (2,886) | (6,736) | (7,162) | ||||
| Change in fair value of derivative instruments | 57 | 879 | 546 | 442 | ||||
| Change in fair value of contingent consideration | — | 5 | — | 304 | ||||
| Other income (expense), net | (3,339) | 527 | (4,360) | (5,561) | ||||
| Loss before income taxes | (14,612) | (4,064) | (26,309) | (31,864) | ||||
| Provision for income taxes | (66) | (181) | (639) | (606) | ||||
| Net loss | $ | (14,678) | $ | (4,245) | $ | (26,948) | $ | (32,470) |
| Basic and diluted net loss per share | $ | (0.61) | $ | (0.18) | $ | (1.13) | $ | (1.40) |
| Weighted average outstanding shares used for basic and diluted net loss per share | 24,091,546 | 23,611,925 | 23,885,412 | 23,184,322 |
ESTABLISHMENT LABS HOLDINGS INC.
Consolidated Balance Sheets
(In thousands)
| September 30,<br>2021 | December 31,<br>2020 | |||
|---|---|---|---|---|
| (Unaudited) | ||||
| Assets | ||||
| Current assets: | ||||
| Cash | $ | 64,623 | $ | 84,523 |
| Accounts receivable, net of allowance for doubtful accounts of $1,542 and $1,143 | 24,704 | 19,127 | ||
| Inventory, net | 26,652 | 23,210 | ||
| Prepaid expenses and other current assets | 8,726 | 5,439 | ||
| Total current assets | 124,705 | 132,299 | ||
| Long-term assets: | ||||
| Property and equipment, net of accumulated depreciation | 16,781 | 16,202 | ||
| Goodwill | 465 | 465 | ||
| Intangible assets, net of accumulated amortization | 3,654 | 4,148 | ||
| Right-of-use operating lease assets, net | 2,307 | 2,610 | ||
| Other non-current assets | 447 | 664 | ||
| Total assets | $ | 148,359 | $ | 156,388 |
| Liabilities and shareholders’ equity | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 10,257 | $ | 9,722 |
| Accrued liabilities | 19,178 | 14,532 | ||
| Other liabilities, short-term | 1,015 | 1,646 | ||
| Total current liabilities | 30,450 | 25,900 | ||
| Long-term liabilities: | ||||
| Note payable, Madryn, net of debt discount and issuance costs | 51,343 | 49,832 | ||
| Madryn put option | 894 | 1,440 | ||
| Operating lease liabilities, non-current | 1,967 | 1,923 | ||
| Other liabilities, long-term | 2,145 | 2,332 | ||
| Total liabilities | 86,799 | 81,427 | ||
| Shareholders’ equity: | ||||
| Total shareholders’ equity | 61,560 | 74,961 | ||
| Total liabilities and shareholders’ equity | $ | 148,359 | $ | 156,388 |