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 first quarter ended March
31, 2023.
First Quarter Highlights and
Outlook
- First quarter worldwide revenue of $46.5 million increased
21.0% year-over-year and was a new quarterly record; excluding the
impact of foreign currency changes, revenue growth in the first
quarter would have been 22.9%.
- 2023 revenue guidance remains $200 million to $210 million, an
increase of 24% to 30% over 2022.
- First quarter loss from operations was $8.2 million compared to
a loss of $5.6 million in the year-ago period as investment in
growth initiatives increased.
- Cash balance of $42.8 million as of March 31, 2023.
- Completed follow-on share offering on April 27, with gross
proceeds of $90.4 million.
- Presented 3-year results from Motiva® U.S. IDE study at The
Aesthetic Meeting on April 20.
- Mia Femtech™ launched in Japan on April 10.
- Announced three-million Motiva® devices are in market on March
29.
“Reporting a record revenue quarter reflects the significant
progress we are making at Establishment Labs,” said Juan José
Chacón-Quirós, Chief Executive Officer. “In April, we launched the
Mia Femtech experience in Japan, the first country in the global
rollout of this new category in breast aesthetics. We also noted
the presentation of the three-year results of the Motiva US IDE
study by Dr. Caroline Glicksman at the Aesthetic Meeting in Miami.
The results were particularly encouraging as the very low rates of
capsular contracture and rupture seen at year two did not increase
in year three. Finally, we fortified our balance sheet with a
follow-on share offering on April 27; the gross proceeds of $90.4
million along with the capital we currently have will allow us to
take complete advantage of our leading science, technology, and
clinical evidence in this industry.”
“The next several months are expected to be just as eventful,”
Mr. Chacón-Quirós continued. “We have entered into a strategic
partnership with Clinique des Champs Elysées to offer the Mia
Femtech experience at all of their locations in France — adding to
the already announced clinic partners in Europe. Our plans for
launch of Motiva in China continue to advance and our PMA has been
accepted by the U.S. FDA and is under review. Our new Sulày�m
campus will begin operation later this year, doubling our
manufacturing capacity while adding new capabilities in R&D,
medical education, and media. We are making progress every day
toward our goal of rebuilding the breast aesthetic and
reconstruction markets through our commitment to women’s health and
wellbeing.”
First Quarter 2023 Financial
Results
Total revenue for the quarter ended March 31, 2023 was $46.5
million compared to $38.5 million for the same period in 2022.
Direct sales comprised approximately 36% of total sales, while
distributor sales made up the balance.
Gross profit for the first quarter was $30.1 million, or 64.7%
of revenue, compared to $24.9 million, or 64.8% of revenue, for the
same period in 2022.
Total operating expenses for the first quarter were $38.2
million, an increase of $7.7 million compared to $30.5 million in
the first quarter of 2022.
SG&A expenses for the first quarter increased approximately
$4.8 million to $31.7 million compared to $26.9 million in the
first quarter of 2022. The increase in SG&A was primarily due
to costs associated with increased revenues and expanding
operations.
R&D expenses increased approximately $2.9 million to $6.5
million in the first quarter compared to $3.6 million for the same
quarter a year ago. The increase was primarily due to an increase
in personnel, compliance and regulatory costs.
Net loss for the first quarter was $11.9 million compared to a
net loss of $5.9 million in the year ago period.
The Company’s cash balance on March 31, 2023 was $42.8 million.
Cash decreased $23.5 million from December 31, 2022, primarily as a
result of operating losses, increases in inventory and accounts
receivable, and investments in new facility construction.
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 (U.S. and
Canada) or (201) 689-8037 (international) and using conference ID
number 13738535. 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 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 the only
regulatory-approved expander in the world with an integrated port
that is MRI conditional and is used to improve outcomes in breast
reconstruction following breast cancer. 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 patents and 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' implants are currently not approved for
commercial distribution in the United States. The Company’s Motiva
implants are undergoing clinical investigation pursuant to U.S. FDA
regulations for investigational medical devices. The Motiva medical
devices used with the minimally invasive system are pending
European Union regulatory approval.
Non-GAAP Financial
Measures
To supplement the consolidated financial results prepared in
accordance with Generally Accepted Accounting Principles (“GAAP”),
we have disclosed in this press release constant currency sales (or
revenue) information, which is a non-GAAP measure that excludes the
impact of foreign exchange currency fluctuations. Fluctuations in
currency exchange rates impact the sales growth rates of our
underlying business. Management believes that excluding the impact
of currency exchange rate fluctuations from its sales growth
provides investors a more useful comparison to historical financial
results. In order to remove the impact of fluctuations in foreign
currency exchange rates, we calculate constant currency revenue,
which represents the outcome that would have resulted had exchange
rates in the current period been the same as those in effect in the
comparable prior period. Management believes that providing
investors with this non-GAAP measure gives them additional
information to enable them to assess, in the same way management
assesses, the Company's current and future continuing operations.
This non-GAAP measure is not in accordance with, or an alternative
for, GAAP, and may be different from non-GAAP measures used by
other companies.
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 1, 2023 and
will be discussed in the company's quarterly report on Form 10-Q
that will be filed on May 10, 2023, 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
March 31,
2023
2022
Revenue
$
46,524
$
38,452
Cost of revenue
16,445
13,516
Gross profit
30,079
24,936
Operating expenses:
Sales, general and administrative
31,706
26,913
Research and development
6,533
3,598
Total operating expenses
38,239
30,511
Loss from operations
(8,160
)
(5,575
)
Interest income
75
20
Interest expense
(3,756
)
(2,292
)
Change in fair value of derivative
instruments
—
(396
)
Other income, net
729
2,709
Loss before income taxes
(11,112
)
(5,534
)
Provision for income taxes
(830
)
(399
)
Net loss
$
(11,942
)
$
(5,933
)
Basic and diluted net loss per share
$
(0.48
)
$
(0.24
)
Weighted average outstanding shares used
for basic and diluted net loss per share
24,678,113
24,310,856
ESTABLISHMENT LABS HOLDINGS
INC.
Consolidated Balance
Sheets
(In thousands)
March 31, 2023
December 31,
2022
(Unaudited)
Assets
Current assets:
Cash
$
42,847
$
66,355
Accounts receivable, net of allowance for
doubtful accounts of $1,003 and $741
41,049
35,423
Inventory, net
46,141
36,583
Prepaid expenses and other current
assets
12,004
11,543
Total current assets
142,041
149,904
Long-term assets:
Property and equipment, net of accumulated
depreciation
57,051
51,092
Goodwill
465
465
Intangible assets, net of accumulated
amortization
4,367
4,608
Right-of-use operating lease assets,
net
3,998
3,702
Other non-current assets
1,437
1,290
Total assets
$
209,359
$
211,061
Liabilities and shareholders’
equity
Current liabilities:
Accounts payable
$
20,254
$
20,034
Accrued liabilities
19,638
17,237
Other liabilities, short-term
1,579
1,688
Total current liabilities
41,471
38,959
Long-term liabilities:
Note payable, net of debt discount and
issuance costs
178,648
175,461
Operating lease liabilities,
non-current
3,415
3,200
Other liabilities, long-term
1,821
1,626
Total liabilities
225,355
219,246
Shareholders’ equity:
Total shareholders’ equity
(15,996
)
(8,185
)
Total liabilities and shareholders’
equity
$
209,359
$
211,061
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230508005255/en/
Investor/Media Contact: Raj Denhoy 415-828-1044
rdenhoy@establishmentlabs.com
Establishment Labs (NASDAQ:ESTA)
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