Establishment Labs Ipo Prospectus

Establishment labs ipo prospectus

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As filed with the Securities and Exchange Commission on June 21, 2018.

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.

20549

___________________

FORM S-1

REGISTRATION STATEMENT

Under The Securities Act of 1933

___________________

Establishment Labs Holdings Inc.

(Exact name of Registrant as specified in its charter)

___________________

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

___________________

Motiva USA LLC

16192 Coastal Highway

Lewes, DE 19958

+506 2434 2400

(Name, address, including zip code, and telephone number, including area code, of agent for service)

___________________

Copies to:

___________________

___________________

(1)

Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.

(2)

Includes the aggregate offering price of additional shares that the underwriters have the option to purchase.

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission acting pursuant to said Section 8(a) may determine.


SUBJECT TO COMPLETION, DATED

June 21, 2018

PRELIMINARY PROSPECTUS

                    Shares

Common Shares

We are offering              common shares.

This is our initial public offering, and no public market currently exists for our common shares. We expect the initial public offering price to be between $         and $         per common share.

We intend to apply to list

our common shares on the Nasdaq Capital Market under the trading symbol “ESTA.”

We are an “emerging growth company” as defined under the federal securities laws.

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Investing in our common shares involves risks. See the section titled “Risk Factors” beginning on page 14.

Neither the Securities and Exchange Commission in the United States nor any other regulatory body has approved or disapproved of these common shares or passed upon the accuracy or adequacy of this prospectus.

Any representation to the contrary is a criminal offense.

Delivery of the common shares in this offering is expected to be made on or about                       , 2018. We have granted the underwriters an option for a period of 30 days from the date of this prospectus to purchase an additional              common shares.

If the underwriters exercise the option in full, the total underwriting discounts and commissions payable by us will be $              and the total proceeds to us, before expenses, will be $              .

 

Joint Book-Running Managers

Lead Manager

BTIG

Prospectus dated                          , 2018.


We and the underwriters have not authorized any person to provide you with information different from that contained in this prospectus or any related free writing prospectus that we authorize to be distributed to you.

We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may provide you.

This prospectus is not an offer to sell, nor is it seeking an offer to buy, these securities in any state where the offer or sale is not permitted. The information in this prospectus speaks only as of the date of this prospectus unless the information specifically indicates that another date applies, regardless of the time of delivery of this prospectus or of any sale of the securities offered hereby.

Through and including , 2018 (25 days after the date of this prospectus), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus.

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This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

No action is being taken in any jurisdiction outside the United States to permit a public offering of the common shares or possession or distribution of this prospectus in that jurisdiction.

Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of the prospectus applicable to that jurisdiction.


CONVENTIONS THAT APPLY TO THIS PROSPECTUS

Except where the context requires otherwise and for purposes of this prospectus only:

“GAAP” refers to the Generally Accepted Accounting Principles in the United States.

“Establishment Labs,” “we,” “us,” “our” or “company” refer to Establishment Labs Holdings Inc.

and its subsidiaries.

“FDA” refers to the United States Food and Drug Administration.

“U.S.” or “United States” refers to the United States of America.

“EU” refers to the European Union.

“$”, “U.S.

do

llars” or “USD” refers to the legal currency of the United States.

The financial statements of our foreign subsidiaries whose functional currencies are the local currencies are translated into U.S. dollars for consolidation as follows: assets and liabilities at the exchange rate as of the applicable balance sheet date, shareholders’ equity at the historical rates of exchange, and income and expense amounts at the average exchange rate for the month.

S-1/A [Amend] - General form for registration of securities under the Securities Act of 1933

Translation adjustments resulting from the translation of the subsidiaries’ accounts are included in “Accumulated other comprehensive income.” Transactions denominated in currencies other than the applicable functional currency are converted to the functional currency at the exchange rate on the transaction date. At period end, monetary assets and liabilities are remeasured to the functional currency using exchange rates in effect at the balance sheet date.

Establishment labs ipo prospectus

Non-monetary assets and liabilities are remeasured at historical exchange rates. Gains and losses resulting from foreign currency transactions are included within “Other income (expense), net.” See Note 2 in the notes to our consolidated financial statements included elsewhere in this prospectus for more information.

We own or have rights to trademarks and trade names that we use in connection with the operation of our business, including Establishment Labs and our logo as well as other brands such as Motiva Implants, SilkSurface/SmoothSilk, VelvetSurface, ProgressiveGel, TrueMonobloc, BluSeal, Divina, Ergonomix and MotivaImagine, among others.

Form S-1 Establishment Labs Holdings Inc.

Other trademarks and trade names appearing in this prospectus are the property of their respective owners. Solely for your convenience, some of the trademarks and trade names referred to in this prospectus are listed without the ® and

TM

symbols, but we will assert, to the fullest extent under applicable law, our rights to our trademarks and trade names.


PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus.

You should read the following summary together with the more detailed information appearing in this prospectus, including the sections titled “Risk Factors,” “Selected Consolidated Financial Data,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business,” and our consolidated financial statements and related notes before deciding whether to purchase our common shares.

Business Overview

We are a medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market.

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Our line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of our MotivaImagine medical technology platform. Post-market surveillance data, which was not generated in connection with an FDA PMA approval study and was self-collected rather than collected at mandatory follow-ups, and published third-party data indicates that Motiva Implants show low rates of adverse events (including rupture, capsular contracture, and safety related reoperations) that we believe compare favorably with those of our competitors.

We believe the proprietary technologies that differentiate our Motiva Implants enable improved safety and aesthetic outcomes and have helped drive our revenue growth. Our MotivaImagine platform enables surgical techniques that we promote as Motiva branded surgeries.

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We have developed other complementary products and services on our MotivaImagine platform, which are aimed at further enhancing patient outcomes.

To date, most of our revenues have been generated from sales of our Motiva Implants. We began selling Motiva Implants outside the United States in October 2010; since then, we have introduced four generations of Motiva Implants, and Motiva Implants are now sold in over 60 countries, including nine of the top ten countries for breast augmentations in 2016 according to the International Society of Aesthetic Plastic Surgery, or ISAPS.

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We currently sell our products either via exclusive distributors or, in certain countries, our direct sales force. We received approval of an investigational device exemption, or IDE, from the FDA in March 2018 to initiate our Motiva Implant clinical trial in the United States.

Establishment labs ipo prospectus

The first patient in the study was enrolled in April 2018, and we anticipate completing enrollment in early 2019. The results of the study are expected to support a pre-market approval, or PMA, submission to the FDA.

We have assembled a broad portfolio of intellectual property related to our medical device and aesthetics products.

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We believe this intellectual property, combined with proprietary manufacturing processes and the regulatory approvals we have successfully obtained outside of the

United States

, provides us with a strong market position. As of April 30, 2018, we own or have rights to three issued and seven pending patents in the United States related to various aspects of our Motiva implants (such as implant barrier layers, surface texture technology, minimally invasive implant delivery systems, and our QInside Safety Technology radio frequency identification devices).

Establishment labs ipo prospectus

In addition, we have six pending foreign applications and six pending PCT applications. We intend to continue to expand our intellectual property portfolio and, combined with our Motiva Implants’ favorable safety profile, obtain FDA approval and drive Motiva’s adoption in the United States, which represents the largest breast augmentation market.

Our revenue for

2015,

2016

and

2017

was

$9.6 million,

$19.8 million

and

$34.7 million

, respectively, an increase of $10.2 million, or 106%, in 2016 compared to 2015, and an increase of

$14.9 million

, or

75%

, in

2017

compared to

2016

.

Net losses increased from

$1.6 million in 2015 to

$22.2 million

in

2016

, and further increased to

$34.9 million

in

2017

, an increase of

57%

compared to 2016.

As of

December 31, 2017

, we had an accumulated deficit of

$67.9 million

.

Our revenue for

the three months ended

March 31, 2017

and 2018

was

$6.9 million

and

$14.8 million

, respectively, an increase of

$7.9 million

, or

114%

.

Net losses increased from

$5.0 million

for the three months ended

March 31, 2017

to

$6.5 million

for the three months ended

March 31, 2018

.

Establishment labs ipo prospectus

As of

March 31, 2018

, we had an accumulated deficit of

$74.4 million

.


Our Market Opportunity

Breast augmentation surgery remains the leading aesthetic surgical procedure by number of procedures globally.

Approximately 1.65 million breast augmentations were performed worldwide in 2016, according to ISAPS.

Establishment Labs Announces Pricing of Initial Public Offering

In addition, according to MarketsandMarkets’ Medical Aesthetics Market - Forecast to 2021 report of November 2016, the global breast implant market was estimated at approximately $1.15 billion in 2016 and is expected to grow at a compound annual growth rate of approximately 8.5% through 2021.

The following table lists the top markets by country for total breast augmentations in 2016 according to ISAPS.

Total Breast Augmentation Procedures

Rank *

Country

Procedures

% of World-Wide Total

1

United States

British Virgin Islands

3842

Not applicable

(State or other jurisdiction of

incorporation or organization)

(Primary Standard Industrial

Classification Code Number)

(I.R.S.

Establishment labs ipo prospectus

Employer

Identification Number)

 

Building B15 and 25

Coyol Free Zone

Alajuela

Costa Rica

+506 2434 2400

 

J.

Casey McGlynn

Elton Satusky

Wilson Sonsini Goodrich & Rosati, P.C.

650 Page Mill Road

Palo Alto, CA 94304

(650) 493-9300

Audrey M.

Robertson

Conyers Dill & Pearman

Commerce House, Wickhams Cay 1

Road Town, Tortola VG1110

British Virgin Islands

(284) 852 1000

Mark B. Weeks

Frank F. Rahmani

John T. McKenna

Cooley LLP

3175 Hanover Street

Palo Alto, CA 94304

(650) 843-5000

Approximate date of commencement of proposed sale to the public:

  As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.

Form S-1/A Establishment Labs Holdings Inc.

¨

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non‑accelerated filer, or a smaller reporting company.

See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”

and “emerging growth company”

in Rule 12b‑2 of the Exchange Act.

(Check one):

Large accelerated filer

¨

 

 

Accelerated filer

¨

Non-accelerated filer

x

 (Do not check if a smaller reporting company)

 

Smaller reporting company

¨

 

 

 

 

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 7(a)(2)(B) of the Securities Act

¨

CALCULATION OF REGISTRATION FEE

Title of Each Class of

Securities to be Registered

Proposed Maximum

Aggregate Offering Price

(1)(2)

Amount of

Registration Fee

Common Shares, no par value

$57,500,000

$7,158.75

The information in this preliminary prospectus is not complete and may be changed.

We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

 

 

 

 

 

 

 

PER SHARE

 

TOTAL

 

 

Initial public offering price

$

 

$

 

 

Underwriting discounts and commissions

(1)

 

$

 

$

 

 

Proceeds to us, before expenses

$

 

$

 

 

 

 

 

 

 

 

(1)  Please see the section titled “Underwriting” for additional information regarding underwriter compensation.

 

Establishment labs ipo prospectus