Establishment Labs Reports Second Quarter 2024 Financial Results

Rhea-AI Summary

Establishment Labs Holdings Inc. (NASDAQ: ESTA) reported Q2 2024 financial results. Worldwide revenue was $44.1 million, with 2024 revenue guidance maintained at $174-184 million. Gross profit was $28.9 million (65.6% of revenue). The company reported a loss from operations of $9.3 million and an Adjusted EBITDA loss of $4.3 million. Cash balance stood at $54.6 million.

Key highlights include:

• FDA PMA preapproval inspection completed
• FDA approval of Motiva Implants expected soon
• 18.7% sequential revenue growth
• Improved adjusted EBITDA loss compared to previous year

The company anticipates strong growth with the upcoming U.S. launch of Motiva Implants.

Positive

• 18.7% sequential revenue growth in Q2
• Improved gross profit margin to 65.6% from 62.3% year-over-year
• Reduced operating expenses by $5.7 million compared to Q2 2023
• Adjusted EBITDA loss improved to $4.3 million from $9.3 million year-over-year
• FDA PMA preapproval inspection completed, with approval expected soon
• Maintained 2024 revenue guidance of $174-184 million (5-11% growth)

Negative

• Q2 revenue decreased to $44.1 million from $48.6 million year-over-year
• Reported net loss of $17.2 million, slightly higher than $16.7 million in Q2 2023
• Cash balance decreased to $54.6 million from December 31, 2023

Insights

Financial Analyst

Establishment Labs' Q2 2024 results show a mixed financial picture. While revenue declined 9.3% year-over-year to $44.1 million, there was a strong sequential growth of 18.7%. The company maintained its 2024 revenue guidance of $174-184 million, indicating confidence in future growth.

Notably, gross profit margin improved to 65.6% from 62.3% last year, driven by geographic mix and higher average selling prices. The company also made significant progress in reducing operating expenses, with SG&A and R&D costs decreasing by $4.2 million and $1.4 million respectively.

While still operating at a loss, the adjusted EBITDA loss narrowed to $4.3 million from $9.3 million in the year-ago period, showing improved operational efficiency. The cash balance of $54.6 million provides a reasonable runway for future operations and potential U.S. market entry.

Medical Device Regulatory Expert

The completion of the FDA PMA preapproval inspection for Motiva Implants is a crucial milestone for Establishment Labs. This suggests that FDA approval could be imminent, potentially opening up the lucrative U.S. market for the company's breast implants.

The U.S. launch of Motiva Implants would be transformative for Establishment Labs, allowing it to compete in the world's largest breast aesthetics market. This could significantly boost revenue and market share, especially given the company's claims of superior clinical and aesthetic outcomes.

However, investors should note that regulatory approvals can be unpredictable and successful market entry will depend on factors such as pricing strategy, marketing efforts and acceptance by U.S. surgeons and patients. The company's preparedness for a potential U.S. launch will be critical in capitalizing on this opportunity.

Market Research Analyst

Establishment Labs' focus on women's health and wellness, particularly in breast aesthetics and reconstruction, positions it well in the growing Femtech market. The company's portfolio, including Motiva implants, Motiva Flora tissue expander and Mia Femtech, demonstrates a commitment to innovation in this space.

With over 3 million Motiva devices delivered across 85+ countries, the company has established a strong international presence. The potential U.S. market entry could be a game-changer, as it would allow Establishment Labs to compete in a market that accounts for a significant portion of global breast implant procedures.

Investors should monitor the company's ability to execute its U.S. launch strategy, maintain its international market share and continue innovating in the Femtech space. The company's patent portfolio and scientific studies provide a solid foundation for future growth, but success will depend on effective commercialization and market adoption of its technologies.

NEW YORK--(BUSINESS WIRE)-- 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.

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 (800) 715-9871 (U.S. and Canada) or (646) 307-1963 (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.

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 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.

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

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

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	)

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240806138099/en/

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What was Establishment Labs' (ESTA) revenue for Q2 2024?

Establishment Labs reported worldwide revenue of $44.1 million for Q2 2024.

How did Establishment Labs' (ESTA) Q2 2024 gross profit compare to the previous year?

Gross profit for Q2 2024 was $28.9 million (65.6% of revenue), compared to $30.3 million (62.3% of revenue) in Q2 2023.

What is Establishment Labs' (ESTA) revenue guidance for 2024?

Establishment Labs maintained its 2024 revenue guidance at $174 million to $184 million, representing a 5% to 11% increase over 2023.

When did Establishment Labs (ESTA) complete the FDA PMA preapproval inspection?

Establishment Labs completed the FDA PMA preapproval inspection on July 26, 2024.

What was Establishment Labs' (ESTA) cash balance as of June 30, 2024?

Establishment Labs reported a cash balance of $54.6 million as of June 30, 2024.