Establishment Labs Reports First Quarter 2024 Financial Results
Establishment Labs Holdings Inc. (NASDAQ: ESTA) reported first quarter 2024 financial results, with worldwide revenue of $37.2 million. The 2024 revenue guidance is $174 million to $184 million, reflecting a 5% to 11% increase over 2023. Gross profit was $24.4 million, with a loss from operations of $8.8 million. Adjusted EBITDA loss improved to $3.7 million. The company's cash balance was $73.0 million as of March 31, 2024. Establishment Labs presented 4-year results from Motiva® U.S. IDE study showing positive outcomes, aiming for FDA approval of Motiva Implants in 2024.
Global medical technology company, Establishment Labs, reported a 2024 first quarter revenue of $37.2 million, showcasing a stable market demand and positive growth outlook.
Significant steps taken to reduce expense base resulted in improved adjusted EBITDA loss to less than $4 million, reflecting a positive trend towards financial stability.
Presented 4-year results from Motiva® U.S. IDE study, demonstrating low rates of capsular contracture and rupture, setting new standards for breast implants, enhancing market reputation.
Continued progress towards FDA approval of Motiva Implants in the U.S., indicating potential revenue growth in 2024.
Net loss for the first quarter was $16.2 million compared to a net loss of $11.9 million in the year-ago period, indicating a decline in profitability.
Total revenue decreased to $37.2 million from $46.5 million for the same period in 2023, signaling a revenue decline potentially impacting shareholder confidence.
R&D expenses decreased to $4.3 million, highlighting a reduction in research and development investments that may impact future product innovation.
Insights
First Quarter Highlights and Outlook
-
First quarter worldwide revenue of
$37.2 million -
2024 revenue guidance remains
$174 million $184 million 5% to11% over 2023. Guidance does not include revenue from Motiva Implants® inthe United States , which is expected in 2024. -
Gross profit for the first quarter was
$24.4 million 65.6% of revenue, compared to$30.1 million 64.7% of revenue, in the year-ago period. -
First quarter loss from operations was
$8.8 million $22.1 million $8.2 million -
Adjusted EBITDA loss of
$3.7 million $17.3 million $4.0 million -
Cash balance of
$73.0 million -
Presented 4-year results from Motiva®
U.S. IDE study at The Aesthetic Meeting on May 2. - Continued progress with FDA on approval of Motiva Implants.
“We are off to a strong start in 2024. Market demand is stabilizing, and we expect to see continued improvement over the course of the year. We have taken meaningful steps to reduce our expense base and our adjusted EBITDA improved significantly to a loss of less than
“Last week, four-year data from the Motiva US IDE study was presented at the Aesthetic Meeting in
First Quarter 2024 Financial Results
Total revenue for the quarter ended March 31, 2024 was
Gross profit for the first quarter was
Total operating expenses for the first quarter were
SG&A expenses for the first quarter decreased approximately
R&D expenses decreased approximately
Net loss for the first quarter was
The Company’s cash balance on March 31, 2024 was
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 (877) 407-8037 (
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
Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in
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 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 reasonable predicted. Such unavailable information could be material to our results computed in accordance with
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 May 9, 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) |
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Three Months Ended
|
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|
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2024 |
|
|
|
2023 |
|
Revenue |
|
$ |
37,167 |
|
|
$ |
46,524 |
|
Cost of revenue |
|
|
12,787 |
|
|
|
16,445 |
|
Gross profit |
|
|
24,380 |
|
|
|
30,079 |
|
Operating expenses: |
|
|
|
|
||||
Sales, general and administrative |
|
|
28,941 |
|
|
|
31,706 |
|
Research and development |
|
|
4,273 |
|
|
|
6,533 |
|
Total operating expenses |
|
|
33,214 |
|
|
|
38,239 |
|
Loss from operations |
|
|
(8,834 |
) |
|
|
(8,160 |
) |
Interest income |
|
|
488 |
|
|
|
75 |
|
Interest expense |
|
|
(4,381 |
) |
|
|
(3,756 |
) |
Other income (expense), net |
|
|
(3,037 |
) |
|
|
729 |
|
Loss before income taxes |
|
|
(15,764 |
) |
|
|
(11,112 |
) |
Provision for income taxes |
|
|
(438 |
) |
|
|
(830 |
) |
Net loss |
|
$ |
(16,202 |
) |
|
$ |
(11,942 |
) |
|
|
|
|
|
||||
Basic and diluted net loss per share |
|
$ |
(0.58 |
) |
|
$ |
(0.48 |
) |
Weighted average outstanding shares used for basic and diluted net loss per share |
|
|
27,788,120 |
|
|
|
24,678,113 |
|
ESTABLISHMENT LABS HOLDINGS INC. Consolidated Balance Sheets (In thousands) |
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March 31,
|
|
December 31,
|
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|
(Unaudited) |
|
|
||
Assets |
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|
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Current assets: |
|
|
|
||
Cash |
$ |
72,980 |
|
$ |
40,035 |
Accounts receivable, net of allowance for doubtful accounts of |
|
50,838 |
|
|
46,918 |
Inventory, net |
|
72,489 |
|
|
79,471 |
Prepaid expenses and other current assets |
|
7,388 |
|
|
8,477 |
Total current assets |
|
203,695 |
|
|
174,901 |
Long-term assets: |
|
|
|
||
Property and equipment, net of accumulated depreciation |
|
79,244 |
|
|
77,205 |
Goodwill |
|
465 |
|
|
465 |
Intangible assets, net of accumulated amortization |
|
9,515 |
|
|
7,987 |
Right-of-use operating lease assets, net |
|
3,908 |
|
|
3,381 |
Other non-current assets |
|
5,011 |
|
|
4,702 |
Total assets |
$ |
301,838 |
|
$ |
268,641 |
Liabilities and shareholders’ equity |
|
|
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Current liabilities: |
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|
|
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Accounts payable |
$ |
31,070 |
|
$ |
41,624 |
Accrued liabilities |
|
15,207 |
|
|
13,690 |
Other liabilities, short-term |
|
1,739 |
|
|
1,836 |
Total current liabilities |
|
48,016 |
|
|
57,150 |
Long-term liabilities: |
|
|
|
||
Note payable, net of debt discount and issuance costs |
|
192,186 |
|
|
188,739 |
Operating lease liabilities, non-current |
|
3,180 |
|
|
2,712 |
Other liabilities, long-term |
|
1,545 |
|
|
1,645 |
Total liabilities |
|
244,927 |
|
|
250,246 |
Shareholders’ equity: |
|
|
|
||
Total shareholders’ equity |
|
56,911 |
|
|
18,395 |
Total liabilities and shareholders’ equity |
$ |
301,838 |
|
$ |
268,641 |
Reconciliation of EBITDA and Adjusted EBITDA The following is a reconciliation of net loss to EBITDA and Adjusted EBITDA: |
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|
Three Months Ended March 31, |
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|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
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Net loss |
$ |
(16,202 |
) |
|
$ |
(11,942 |
) |
Interest expense |
|
(4,381 |
) |
|
|
(3,756 |
) |
Provision for income taxes |
|
(438 |
) |
|
|
(830 |
) |
Depreciation and amortization |
|
(1,268 |
) |
|
|
(936 |
) |
EBITDA |
|
(10,115 |
) |
|
|
(6,420 |
) |
Stock compensation expense |
|
(3,444 |
) |
|
|
(3,324 |
) |
Foreign currency gains (losses) |
|
(3,019 |
) |
|
|
919 |
|
Adjusted EBITDA |
$ |
(3,652 |
) |
|
$ |
(4,015 |
) |
|
|
|
|
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View source version on businesswire.com: https://www.businesswire.com/news/home/20240508747480/en/
Investor/Media Contact:
Raj Denhoy
415 828-1044
rdenhoy@establishmentlabs.com
Source: Establishment Labs Holdings Inc.
FAQ
What was Establishment Labs' first quarter revenue for 2024?
Establishment Labs reported a first quarter revenue of $37.2 million for 2024.
What is Establishment Labs' 2024 revenue guidance?
Establishment Labs' 2024 revenue guidance is $174 million to $184 million, representing a 5% to 11% increase over 2023.
What was the gross profit and loss from operations for the first quarter of 2024?
The gross profit for the first quarter was $24.4 million, with a loss from operations of $8.8 million.
What was the cash balance of Establishment Labs as of March 31, 2024?
Establishment Labs' cash balance was $73.0 million as of March 31, 2024.
What significant study results did Establishment Labs present?
Establishment Labs presented 4-year results from the Motiva® U.S. IDE study, showcasing positive outcomes such as low rates of capsular contracture and rupture.
