Establishment Labs Reports Second Quarter 2019 Financial Results
- 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 Eastand Asia Pacific, as well as by the successful transition to a direct sales model in Europeand 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
Taiwanand Thailand, one of the largest breast aesthetic markets in Asia.
- Continued to progress its U.S.
FDAclinical 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 millionfrom $80.0 to $84.0 millionpreviously.
“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
“In parallel with our ongoing research and development activities, our U.S.
Second Quarter 2019 Financial Results
Gross profit for the second quarter of 2019 was
Total operating expenses for the second quarter of 2019 increased
SG&A expense increased
R&D expenses increased
Net losses for the second quarter of 2019 was
The Company’s cash balance as of
Full Year 2019 Financial Outlook
The Company anticipates full-year 2019 revenues in the range of
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.
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
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended
|Six Months Ended
|Cost of revenue||8,672||5,492||18,198||12,393|
|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||)|
|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||)|
|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|
Condensed Consolidated Balance Sheets
(In thousands, except share data)
|Accounts receivable, net of allowance for doubtful accounts of $902 and $926||21,312||17,648|
|Prepaid expenses and other current assets||4,455||4,303|
|Total current assets||84,177||99,435|
|Property and equipment, net of accumulated depreciation||16,708||12,913|
|Intangible assets, net of accumulated amortization||3,081||3,445|
|Other non-current assets||370||315|
|Liabilities and shareholders’ equity|
|Other liabilities, short term||4,137||4,083|
|Total current liabilities||21,386||16,447|
|Note payable, Madryn, net of debt discount and issuance costs||24,053||22,322|
|Madryn put option||2,160||4,768|
|Other liabilities, long term||3,415||3,551|
|Total shareholders’ equity||53,787||69,485|
|Total liabilities and shareholders’ equity||$||104,801||$||116,573|
LifeSci Advisors, LLC
Source: Establishment Labs Holdings, Inc.