Document


 
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 13, 2019
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
Not applicable
(State or other jurisdiction of
incorporation or organization)
(Commission File No.)

(I.R.S. Employer
Identification Number)
Building B15 and 25
Coyol Free Zone
Alajuela
Costa Rica
(Address of principal executive offices) (Zip Code)
 
+506 2434 2400
 
 
(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 x
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. ¨
 





Item 2.02.     Results of Operations and Financial Condition.

On August 13, 2019, 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, 2019 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








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 13, 2019
 
By:
/s/ Renee M. Gaeta
 
 
 
Name:
Renee M. Gaeta
 
 
 
Title:
Chief Financial Officer
 
 
 
 
 



Exhibit
EXHIBIT 99.1
https://cdn.kscope.io/2bf185322cc3e3a50e637fbc17f20ead-logo_imagea07.gif


Establishment Labs Reports Second Quarter 2019 Financial Results

August 13, 2019
NEW YORK -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced its financial results for the second quarter ended June 30, 2019.
Business Highlights
Reported second quarter 2019 worldwide sales of $21.7 million, an increase of 58.2% year-over-year.
Grew revenue through the ongoing strong adoption of Motiva Implants® across addressable markets, with double digit growth in Latin America, Europe, Middle East and Asia Pacific, as well as by the successful transition to a direct sales model in Europe and Brazil.
To date, Motiva Implants® continue to be unaffected by the recent safety related bans on silicone gel filled breast implants associated with BIA-ALCL from international regulatory bodies.
Launched Motiva® in Taiwan and Thailand, one of the largest breast aesthetic markets in Asia.
Continued to progress its U.S. FDA clinical trial, with all surgeries in the primary and revision augmentation cohorts completed and enrollment progressing in the reconstruction cohorts.
Raised full-year 2019 revenue guidance to a range of $84.0 to $86.0 million from $80.0 to $84.0 million previously.

“During the second quarter, we continued to prove the strength of our Women’s Health story, driving strong sales growth of over 58%, while regulatory agencies worldwide are placing restrictions on the rest of the industry,” said Juan José Chacón-Quirós, Chief Executive Officer of Establishment Labs. “We believe this growth trajectory speaks to the clear differentiation and improved safety and aesthetic outcomes of our product portfolio, as well as to the effectiveness of the direct sales force model that we have implemented in Europe and Brazil.
“In parallel with our ongoing research and development activities, our U.S. FDA clinical trial is progressing with all surgeries now complete in the primary and revision augmentation cohorts and enrollment continuing in the reconstruction cohorts. Importantly, we are implementing a bifurcation strategy in the U.S. that will allow us to submit for the aesthetic cohorts sooner while pursuing approval for the reconstruction cohorts separately. I am very pleased with our progress to this point and I look forward to a strong second half of the year,” Mr. Chacón-Quirós concluded.

Second Quarter 2019 Financial Results
Revenues increased $8.0 million, or 58.2 %, to $21.7 million for the second quarter of 2019, as compared to $13.7 million in the same period in 2018. The increase was primarily due to increased sales of Motiva Implants®, driven by greater market penetration in existing geographies and commencement of sales in new geographies including certain European direct markets.

Gross profit for the second quarter of 2019 was $13.0 million, or 60.0 % of revenues, compared to gross profit of $8.2 million, or 59.9 % of revenues in the same period in 2018.

Total operating expenses for the second quarter of 2019 increased $7.9 million, or 54.1%, to $22.4 million, as compared to $14.5 million in the same period in 2018 driven by continued investment across the company, including the expansion into European direct markets and the related supporting systems required for this growth.
 
SG&A expense increased $7.6 million, or 69.9%, to $18.4 million for the three months ended June 30, 2019, compared to $10.8 million for the three months ended June 30, 2018. The increase in SG&A was primarily due to a $3.1 million increase in personnel costs as a result of the hiring of additional sales, marketing and administrative



employees, a $2.3 million increase in sales and administrative consulting fees, including stock compensation, a $1.1 million increase in sales commissions and a $0.7 million increase in marketing expenses.

R&D expenses increased $0.3 million, or 8.0%, to $4.0 million for the three months ended June 30, 2019, compared to $3.7 million for the three months ended June 30, 2018. The increase in R&D expenses was primarily due to $0.5 million increase in R&D personnel costs and $0.1 million increase in expenditures related to the initiation of our Premarket Approval (PMA) clinical study in the United States, primarily attributable to third parties fees for set-up and management of the clinical trial.

Net losses for the second quarter of 2019 was $9.0 million, as compared to a net loss of $5.4 million in the same period in 2018, a result of the Company’s continued growth and investments in operations to support the expected increase in market demand.

The Company’s cash balance as of June 30, 2019 was $31.9 million and subsequently the Company has drawn the $25.0 million remaining from its credit facility on August 12, 2019.

Full Year 2019 Financial Outlook
The Company anticipates full-year 2019 revenues in the range of $84.0 to $86.0 million, up from the previous range of $80.0 million to $84.0 million.
Conference Call
Establishment Labs will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss its financial results. The conference call can be accessed by dialing (877) 376-9925 (U.S. and Canada) or (629) 228-0732 (international) and using the conference ID: 1168908. In addition, the webcast will be available on the Investor Relations section of the Company's website at www.establishmentlabs.com.
The webcast will be available for 30 days following the call on the Investor Relations section of the Company's website at www.establishmentlabs.com.

About Establishment Labs
Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in 75 countries through exclusive distributors or the Company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant® clinical trial in the United States in April 2018. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes the Divina ® 3D Simulation System, MotivaImagine® Centers and other products and services. Please visit the website for additional information: www.establishmentlabs.com.

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,” “would,” “may” or other similar expressions in this press release, and includes statements related to the expected growth in sales of Motiva Implants®, product development, and the PMA clinical trial currently being conducted to obtain approval of Motiva Implants® in the U.S. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements



expressing general optimism about future operating results, 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, they are not guarantees of future performance, and some will inevitably prove to be incorrect. As a result, our actual future results may differ from our expectations, and those differences may be material. Factors that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the Company’s annual report on Form 10-K filed on March 20, 2019, quarterly reports on Form 10-Q, and 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.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
 
 
 
 
 
 
 
 
 
 
 
Three Months Ended
June 30,
 
Six Months Ended
June 30,
 
 
2019
 
2018
 
2019
 
2018
Revenue
 
$
21,684

 
$
13,709

 
$
42,462

 
$
28,525

Cost of revenue
 
8,672

 
5,492

 
18,198

 
12,393

Gross profit
 
13,012

 
8,217

 
24,264

 
16,132

Operating expenses:
 
 
 
 
 
 
 
 
Sales, general and administrative
 
18,394

 
10,829

 
34,450

 
19,477

Research and development
 
4,001

 
3,705

 
7,585

 
5,852

Total operating expenses
 
22,395

 
14,534

 
42,035

 
25,329

Loss from operations
 
(9,383
)
 
(6,317
)
 
(17,771
)
 
(9,197
)
Interest income
 
4

 

 
10

 
4

Interest expense
 
(2,521
)
 
(2,173
)
 
(4,763
)
 
(4,344
)
Change in fair value of derivative instruments
 
2,640

 
5,830

 
2,608

 
4,525

Change in fair value of contingent consideration
 
137

 
(389
)
 
362

 
(752
)
Other income (expense), net
 
118

 
(2,159
)
 
(186
)
 
(1,964
)
Loss before income taxes
 
(9,005
)
 
(5,208
)
 
(19,740
)
 
(11,728
)
Provision for income taxes
 
(35
)
 
(152
)
 
(79
)
 
(162
)
Net loss
 
$
(9,040
)
 
$
(5,360
)
 
$
(19,819
)
 
$
(11,890
)
 
 
 
 
 
 
 
 
 
Basic and diluted net loss per share
 
$
(0.44
)
 
$
(0.35
)
 
$
(0.97
)
 
$
(0.79
)
Weighted average outstanding shares used for basic and diluted net loss per share
 
20,448,643

 
15,351,899

 
20,407,912

 
14,981,070






ESTABLISHMENT LABS HOLDINGS INC.
Condensed Consolidated Balance Sheets
(In thousands, except share data)

 
 
 
 
 
June 30,
2019
 
December 31,
2018
 
(Unaudited)
 
 
Assets
 
 
 
Current assets:
 
 
 
Cash
$
31,870

 
$
52,639

Accounts receivable, net of allowance for doubtful accounts of $902 and $926
21,312

 
17,648

Inventory
26,540

 
24,845

Prepaid expenses and other current assets
4,455

 
4,303

Total current assets
84,177

 
99,435

Long-term assets:
 
 
 
Property and equipment, net of accumulated depreciation
16,708

 
12,913

Goodwill
465

 
465

Intangible assets, net of accumulated amortization
3,081

 
3,445

Other non-current assets
370

 
315

Total assets
$
104,801

 
$
116,573

Liabilities and shareholders’ equity
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
8,531

 
$
6,239

Accrued liabilities
8,718

 
6,125

Other liabilities, short term
4,137

 
4,083

Total current liabilities
21,386

 
16,447

Long-term liabilities:
 
 
 
Note payable, Madryn, net of debt discount and issuance costs
24,053

 
22,322

Madryn put option
2,160

 
4,768

Other liabilities, long term
3,415

 
3,551

Total liabilities
51,014

 
47,088

Total shareholders’ equity
53,787

 
69,485

Total liabilities and shareholders’ equity
$
104,801

 
$
116,573

 
 
 
 








Investor Relations Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com