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, 2023.
First Quarter Highlights and
Outlook
- Second quarter worldwide revenue of $48.6 million increased
18.0% year-over-year and was a new quarterly record.
- 2023 revenue guidance remains $200 million to $210 million, an
increase of 24% to 30% over 2022.
- Second quarter loss from operations was $13.7 million compared
to a loss of $10.4 million in the year-ago period as investment in
growth initiatives increased.
- Cash balance of $90.2 million as of June 30, 2023.
- Completed 1.265 million share follow-on offering on April
27.
- Announced minimally invasive tools received CE marking under
European MDR on May 30.
- Opened Sulày�m Innovation Campus in Costa Rica on July 19.
“The second quarter was another record for Establishment Labs as
we continue to grow well in excess of our underlying markets,” said
Juan José Chacón-Quirós, Chief Executive Officer. “The momentum in
our business remains high and with the ongoing global roll-out of
Mia Femtech and the pending approval of Motiva in China, we are
well positioned to have a strong finish to the year. We now have
fourteen Mia clinic partners and the early response to our
direct-to-consumer activities is proving that Mia is drawing new
women into breast aesthetics as they find significant value in a
true minimally invasive offering. Our U.S. PMA is progressing
through the approval process and our preparations for
commercialization continue in earnest.”
“Last month, we held the grand opening of our a new Sulày�m
Innovation Campus,” Mr. Chacón-Quirós continued. “This new facility
will more than double our manufacturing capacity and provides new
capabilities in R&D, medical education, and media. Our
foundations are getting stronger, and we are better positioned than
we have ever been to transform our markets and to make a meaningful
change in the lives of women around the world.”
Second Quarter 2023 Financial
Results
Total revenue for the quarter ended June 30, 2023 was $48.6
million compared to $41.2 million for the same period in 2022.
Direct sales comprised approximately 37% of total sales, while
distributor sales made up the balance.
Gross profit for the second quarter was $30.3 million, or 62.3%
of revenue, compared to $27.5 million, or 66.7% of revenue, for the
same period in 2022.
Total operating expenses for the second quarter were $44.0
million, an increase of $6.1 million compared to $37.9 million in
the second quarter of 2022.
SG&A expenses for the second quarter increased approximately
$4.0 million to $37.0 million compared to $33.0 million in the
second quarter of 2022. The increase in SG&A was primarily due
to costs associated with investment in growth initiatives and
expanding operations.
R&D expenses increased approximately $2.0 million to $6.9
million in the second quarter compared to $4.9 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 second quarter was $16.7 million compared to a
net loss of $37.1 million in the year ago period.
The Company’s cash balance on June 30, 2023 was $90.2 million.
Cash increased $23.8 million from December 31, 2022, primarily as a
result of the 1.265 million share follow-on offering completed on
April 27 offset by 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 13740398. 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' implants and tools 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.
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 August 9, 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 June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Revenue
$
48,561
$
41,190
$
95,085
$
79,642
Cost of revenue
18,300
13,736
34,745
27,252
Gross profit
30,261
27,454
60,340
52,390
Operating expenses:
Sales, general and administrative
37,027
32,957
68,733
59,870
Research and development
6,947
4,903
13,480
8,501
Total operating expenses
43,974
37,860
82,213
68,371
Loss from operations
(13,713
)
(10,406
)
(21,873
)
(15,981
)
Interest income
170
32
245
52
Interest expense
(3,620
)
(3,388
)
(7,376
)
(5,680
)
Change in fair value of derivative
instruments
—
1,099
—
703
Other income (expense), net
1,343
(4,860
)
2,072
(2,151
)
Loss on extinguishment of debt
—
(19,019
)
—
(19,019
)
Loss before income taxes
(15,820
)
(36,542
)
(26,932
)
(42,076
)
Provision for income taxes
(925
)
(564
)
(1,755
)
(963
)
Net loss
$
(16,745
)
$
(37,106
)
$
(28,687
)
$
(43,039
)
Basic and diluted net loss per share
$
(0.65
)
$
(1.52
)
$
(1.14
)
$
(1.77
)
Weighted average outstanding shares used
for basic and diluted net loss per share
25,615,444
24,396,847
25,144,375
24,354,005
ESTABLISHMENT LABS HOLDINGS
INC.
Consolidated Balance
Sheets
(In thousands)
June 30, 2023
December 31,
2022
(Unaudited)
Assets
Current assets:
Cash
$
90,182
$
66,355
Accounts receivable, net of allowance for
doubtful accounts of $1,223 and $741
51,395
35,423
Inventory, net
56,370
36,583
Prepaid expenses and other current
assets
11,070
11,543
Total current assets
209,017
149,904
Long-term assets:
Property and equipment, net of accumulated
depreciation
66,208
51,092
Goodwill
465
465
Intangible assets, net of accumulated
amortization
4,229
4,608
Right-of-use operating lease assets,
net
3,811
3,702
Other non-current assets
1,569
1,290
Total assets
$
285,299
$
211,061
Liabilities and shareholders’ equity
(deficit)
Current liabilities:
Accounts payable
$
24,359
$
20,034
Accrued liabilities
17,434
17,237
Other liabilities, short-term
1,480
1,688
Total current liabilities
43,273
38,959
Long-term liabilities:
Note payable, net of debt discount and
issuance costs
181,970
175,461
Operating lease liabilities,
non-current
3,191
3,200
Other liabilities, long-term
1,992
1,626
Total liabilities
230,426
219,246
Shareholders’ equity (deficit):
Total shareholders’ equity (deficit)
54,873
(8,185
)
Total liabilities and shareholders’ equity
(deficit)
$
285,299
$
211,061
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230808260399/en/
Investor/Media Contact: Raj Denhoy 415 828-1044
rdenhoy@establishmentlabs.com
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