Form 8-K - Current report

5062434 24000001688757false00016887572024-08-062024-08-06

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

August 6, 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)

Buiding 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 2.02.     Results of Operations and Financial Condition.

On August 6, 2024, Establishment Labs Holdings Inc. (the “Company”) issued a press release announcing the Company’s financial results for the three and six months ended June 30, 2024 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 August 6, 2024.

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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:

August 6, 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 Reports Second Quarter 2024 Financial Results

NEW YORK, NY, August 6, 2024 -- 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 financial results for the second quarter ended June 30, 2024.

Second Quarter Highlights and Outlook

•Second quarter worldwide revenue of $44.1 million.

•2024 revenue guidance remains $174 million to $184 million, an increase of 5% to 11% over 2023.

•Gross profit for the second quarter was $28.9 million, or 65.6% of revenue, compared to $30.3 million, or 62.3% of revenue in the year-ago period.

•Second quarter loss from operations was $9.3 million compared to a loss of $13.7 million in the year-ago period.

•Adjusted EBITDA loss of $4.3 million compared to a loss of $9.3 million in the year-ago period.

•Cash balance of $54.6 million as of June 30, 2024.

•FDA PMA preapproval inspection completed July 26, 2024.

•FDA approval of Motiva Implants expected shortly.

“The strong sequential revenue growth of 18.7% in the second quarter is an important achievement as we return to growth. We also saw the tangible results of our efforts to reduce our expense base, with adjusted EBITDA improving to a loss of $4.3 million, less than half the loss we saw in the year ago period,” said Juan José Chacón-Quirós, Chief Executive Officer.

“Late last month, the U.S. FDA completed the PMA preapproval inspection of our manufacturing facility. We expect approval of Motiva Implants in the United States soon,” Mr. Chacón-Quirós continued. “Our launch in the U.S. will be a watershed event in our journey to transform breast aesthetics and reconstruction. The new standard we have set for clinical and aesthetic outcomes in these categories will now be available to women and surgeons in the largest market in the world. We are on a clear path for global market leadership and have many years of strong and healthy growth ahead of us.”

Second Quarter 2024 Financial Results

Total revenue for the quarter ended June 30, 2024 was $44.1 million compared to $48.6 million for the same period in 2023.

Gross profit for the second quarter was $28.9 million, or 65.6% of revenue, compared to $30.3 million, or 62.3% of revenue, for the same period in 2023. The increase in gross profit margin was primarily driven by geographic mix and higher average selling prices.

Total operating expenses for the second quarter were $38.3 million, a decrease of $5.7 million compared to $44.0 million in the second quarter of 2023.

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SG&A expenses for the second quarter decreased approximately $4.2 million to $32.8 million compared to $37.0 million in the second quarter of 2023. The decrease in SG&A was primarily the result of the cost reduction initiatives, including headcount reductions.

R&D expenses decreased approximately $1.4 million to $5.5 million in the second quarter compared to $6.9 million for the same quarter a year ago. The decrease was primarily due to reductions in personnel costs.

Net loss for the second quarter was $17.2 million compared to a net loss of $16.7 million in the year ago period.

The Company’s cash balance on June 30, 2024 was $54.6 million. Cash increased $14.6 million from December 31, 2023, primarily as a result of the private placement offering completed on January 9, partially offset by operating losses and investments in the new manufacturing facility.

Conference Call and Webcast Information

Establishment Labs will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss its financial results. The conference call can be accessed by dialing [phone] (U.S. and Canada) or [phone] (international) and using conference ID number 7160745. In addition, the live and archived webcast will be available in 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 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 over three 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 25 separate patent families worldwide and over 50 scientific 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. In 2018, the Company received an investigational device exemption (IDE) from the FDA for Motiva Implants® and began a clinical trial to support regulatory approval in the United States. Please visit our website for additional information at www.establishmentlabs.com.

Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States. The Company’s implants are undergoing PMA clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.

Non-GAAP Financial Measures

To supplement our financial results presented in accordance with GAAP, this release includes the following measures defined by the Securities and Exchange Commission as non-GAAP financial measures: EBITDA and Adjusted EBITDA. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP, and may be different from non-GAAP measures used by other companies, limiting the usefulness of the measures for comparison with other companies.

EBITDA is defined as net income or loss excluding: (1) interest income and expense; (2) provision for income taxes; and (3) depreciation and amortization. We consider EBITDA useful to an investor in evaluating and facilitating comparisons of our operating performance between periods by removing the impact of our capital structure (primarily interest expense) and asset base (primarily depreciation and amortization) from our operating results.

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We also present Adjusted EBITDA which includes additional adjustments for items such as other non-cash charges, gains or losses on extinguishment of debt, share-based compensation and foreign currency gains and losses. We believe that Adjusted EBITDA provides useful supplemental information to investors regarding our ongoing operating performance that, when considered with net income and EBITDA, is beneficial to an investor's understanding of our performance.

We believe disclosure of this information is also useful to investors as it provides insight into the earnings that management uses to make strategic decisions. These non-GAAP financial measures should be considered along with, but not as alternatives to, net income or loss as prescribed by GAAP as a measure of our operating performance. EBITDA and Adjusted EBITDA do not represent cash generated from operating activities under GAAP and should not be considered as alternatives to cash flows from operations or any other operating performance measure prescribed by GAAP. These measures are not measures of our liquidity, nor are indicative of funds available to fund our cash needs. These measurements do not reflect cash expenditures for long-term assets and other items that have been and will be incurred. EBITDA and Adjusted EBITDA may include funds that may not be available for management’s discretionary use due to functional requirements to conserve funds for capital expenditures, property acquisitions, and other commitments and uncertainties.

Please see “Reconciliation of EBITDA and Adjusted EBITDA” for a reconciliation of these measures to net income (loss), the most directly comparable financial measure. This release also includes information about our expectations regarding Adjusted EBITDA on a forward-looking basis. We have not provided a reconciliation of such forward-looking Adjusted EBITDA information because a reconciliation of such measure to our expected GAAP net income (loss) on a forward-looking basis is not available without unreasonable efforts. The timing or amount of various reconciling items that would impact the forward-looking expectations for this non-GAAP financial measure are uncertain, depend on various factors and cannot be reasonably predicted. Such unavailable information could be material to our results computed in accordance with U.S. GAAP.

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

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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 4, 2024 and will be discussed in the company's quarterly report on Form 10-Q that will be filed on August 7, 2024, which risks and uncertainties may be updated in the future in 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 June 30,												Six Months Ended June 30,
						2024						2023						2024						2023
Revenue						$	44,117					$	48,561					$	81,284					$	95,085
Cost of revenue						15,181						18,300						27,968						34,745
Gross profit						28,936						30,261						53,316						60,340
Operating expenses:
Sales, general and administrative						32,792						37,027						61,733						68,733
Research and development						5,488						6,947						9,761						13,480
Total operating expenses						38,280						43,974						71,494						82,213
Loss from operations						(9,344)						(13,713)						(18,178)						(21,873)
Interest income						556						170						1,044						245
Interest expense						(5,186)						(3,620)						(9,567)						(7,376)
Other income (expense), net						(2,779)						1,343						(5,816)						2,072
Loss before income taxes						(16,753)						(15,820)						(32,517)						(26,932)
Provision for income taxes						(428)						(925)						(866)						(1,755)
Net loss						$	(17,181)					$	(16,745)					$	(33,383)					$	(28,687)
Basic and diluted net loss per share						$	(0.62)					$	(0.65)					$	(1.21)					$	(1.14)
Weighted average outstanding shares used for basic and diluted net loss per share						27,905,614						25,615,444						27,679,832						25,144,375

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ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Balance Sheets

(In thousands)

			June 30, 2024						December 31, 2023
			(Unaudited)
Assets
Current assets:
Cash			$	54,600					$	40,035
Accounts receivable, net of allowance for credit losses of $2,019 and $1,841			59,982						46,918
Inventory, net			64,213						79,471
Prepaid expenses and other current assets			7,337						8,477
Total current assets			186,132						174,901
Long-term assets:
Property and equipment, net of accumulated depreciation			79,546						77,205
Goodwill			465						465
Intangible assets, net of accumulated amortization			10,041						7,987
Right-of-use operating lease assets, net			3,717						3,381
Other non-current assets			5,187						4,702
Total assets			$	285,088					$	268,641
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable			$	28,420					$	41,624
Accrued liabilities			11,812						13,690
Other liabilities, short-term			1,660						1,836
Total current liabilities			41,892						57,150
Long-term liabilities:
Note payable, net of debt discount and issuance costs			193,732						188,739
Operating lease liabilities, non-current			2,989						2,712
Other liabilities, long-term			1,456						1,645
Total liabilities			240,069						250,246
Shareholders’ equity:
Total shareholders’ equity			45,019						18,395
Total liabilities and shareholders’ equity			$	285,088					$	268,641

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ESTABLISHMENT LABS HOLDINGS INC.

Reconciliation of EBITDA and Adjusted EBITDA

(In thousands)

(Unaudited)

The following is a reconciliation of net loss to EBITDA and Adjusted EBITDA:

			Three Months Ended June 30,												Six Months Ended June 30,
			2024																		2023						2024						2023
Net loss			$	(17,181)																	$	(16,745)					$	(33,383)					$	(28,687)
Interest expense			(5,186)																		(3,620)						(9,567)						(7,376)
Interest income			556																		170						1,044						245
Provision for income taxes			(428)																		(925)						(866)						(1,755)
Depreciation and amortization			(1,268)																		(947)						(2,690)						(1,883)
EBITDA			(10,855)																		(11,423)						(21,304)						(17,918)
Stock compensation expense			(3,757)																		(3,616)						(7,202)						(6,940)
Foreign currency gain (loss)			(2,764)																		1,460						(5,783)						2,379
Adjusted EBITDA			$	(4,334)																	$	(9,267)					$	(8,319)					$	(13,357)

Cover	Aug. 06, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Aug. 06, 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	Buiding B15 and 25
Entity Address, Address Line Two	Coyol Free Zone
Entity Address, City or Town	Alajuela
Entity Address, Country	CR
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
Country Region	506
City Area Code	24
Local Phone Number	34 2400
Entity Central Index Key	0001688757
Amendment Flag	false

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