Financial Data and Key Metrics Changes - Record revenue in Q4 2022 totaled $43.8 million, a 24% increase over Q4 2021, with growth of approximately 28% excluding foreign currency impacts [15][24] - For the full year 2022, revenue totaled $161.7 million, a 28% increase over 2021, with a 32% growth rate when excluding currency changes [15] - The company provided revenue guidance for 2023 in the range of $200 million to $210 million, representing estimated growth of 24% to 30% over 2022 [16][37] Business Line Data and Key Metrics Changes - Direct sales accounted for approximately 37% of sales in Q4 2022, with distributor sales making up the remainder [24] - The rollout of the Motiva Flora tissue expander continues to receive positive market feedback, with increasing adoption among surgeons [18] Market Data and Key Metrics Changes - Sales distribution in Q4 2022: Europe approximately 28%, Asia Pacific and Middle East 40%, and Latin America the balance, with Brazil accounting for about 14.6% of total quarterly sales [25] - The company expects regulatory approval for Motiva in China in the first half of 2023, following the lifting of COVID restrictions [21] Company Strategy and Development Direction - Establishment Labs aims to create a new category in breast aesthetics with Mia, targeting women who prefer minimally invasive procedures [12] - The company is focused on improving breast reconstruction and democratizing access to these services globally, with a long-term revenue goal of $500 million by 2026 [22][50] - The new manufacturing facility is expected to more than double production capacity, allowing the company to meet over half of the current global demand [47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving growth targets, citing strong momentum in the business and expected contributions from new initiatives like Mia in China [39][50] - The company is preparing for a busy 2023, with significant events including the commercial launch of Mia and the Motiva launch in China [41] Other Important Information - R&D expenses for Q4 2022 increased to $6.5 million, while total operating expenses rose to $41.3 million, reflecting investments in growth initiatives [26][32] - The gross profit for Q4 2022 was $28.2 million, or 64.3% of revenue, impacted by foreign currency fluctuations [33] Q&A Session Summary Question: Infrastructure for U.S. and Mia launch in Europe - Management discussed the unique business model for Mia, emphasizing partnerships with selected clinics rather than traditional sales reps [42][43] Question: 2023 guidance and contributions from Mia and China - Management clarified that the 2023 guidance does not include U.S. revenue, but expects contributions from Mia and China to build throughout the year [55][56] Question: Launch progress of Mia in Japan - Management confirmed the first clinic partner in Japan and highlighted the importance of demonstrating the new consumer base for Mia [70][71] Question: Gross margin expectations - Management indicated that while initial launches may be margin dilutive, overall gross margins are expected to improve over time due to new products and geographic expansions [76][80] Question: Regulatory environment and potential for faster approval - Management stated it is too early to predict the timeline for U.S. approval but remains focused on the regulatory process [97]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38593 Establishment Labs Holdings Inc. (Exact name of Registrant as specified in its charter) Briti ...

Establishment Labs Holdings Inc. (NASDAQ:ESTA) Q3 2022 Earnings Conference Call November 7, 2022 4:30 PM ET Company Participants Raj Denhoy – Chief Financial Officer Juan Jose Chacon-Quiros – Chief Executive Officer Conference Call Participants Anthony Petrone – Mizuho Group Josh Jennings – Cowen George Sellers – Stephens Marie Thibault – BTIG Neil Chatterji – B. Riley Securities Operator Good afternoon. Welcome to Establishment Labs' Third Quarter 2022 Earnings Conference Call. [Operator Instructions] I wi ...

Establishment Labs Holdings, Inc. (NASDAQ:ESTA) Q2 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Juan Jose Chacon Quiros - Founder and CEO Rajbir Denhoy - CFO Conference Call Participants Chris Cooley - Stephens Zach Weiner - Jefferies Josh Jennings - Cowen Marie Thibault - BTIG Philip Coover - Goldman Sachs Anthony Petrone - Mizuho Group Operator Good afternoon. Welcome to Establishment Labs' Second Quarter 2022 Earnings Call. At this time, all participants will be in a liste ...

Part I. Financial Information [Item 1. Financial Statements - Unaudited](index=6&type=section&id=Item%201.%20Financial%20Statements%20-%20Unaudited) The unaudited statements show revenue growth, a wider net loss from debt extinguishment, and major debt refinancing [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and liabilities increased significantly due to a new major debt facility and related investments Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $91,259 | $53,415 | | Total Current Assets | $156,428 | $113,271 | | Property and equipment, net | $35,359 | $18,658 | | **Total Assets** | **$199,883** | **$139,529** | | **Liabilities & Equity** | | | | Total Current Liabilities | $34,752 | $31,889 | | Note payable, Oaktree, net | $145,482 | $0 | | Note payable, Madryn, net | $0 | $51,906 | | **Total Liabilities** | **$184,016** | **$88,790** | | **Total Shareholders' Equity** | **$15,867** | **$50,739** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Revenue grew year-over-year, but a one-time loss on debt extinguishment drove a substantial increase in net loss Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $41,190 | $31,994 | $79,642 | $62,330 | | Gross Profit | $27,454 | $21,468 | $52,390 | $41,558 | | Loss from Operations | ($10,406) | ($4,634) | ($15,981) | ($6,730) | | Loss on extinguishment of debt | ($19,019) | $0 | ($19,019) | $0 | | **Net Loss** | **($37,106)** | **($5,322)** | **($43,039)** | **($12,270)** | | Basic and diluted net loss per share | ($1.52) | ($0.22) | ($1.77) | ($0.51) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Financing activities provided significant cash from new debt, funding increased investing and operating cash outflows Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($16,170) | ($7,368) | | Net cash used in investing activities | ($19,553) | ($2,465) | | Net cash provided by financing activities | $74,013 | $2,208 | | **Net increase (decrease) in cash** | **$37,844** | **($7,717)** | | Cash at end of period | $91,259 | $76,806 | - Financing activities were dominated by the new Oaktree debt agreement, which provided **$143.6 million** net of costs, and the full repayment of the Madryn debt agreement for **$71.7 million**[40](index=40&type=chunk) - Investing activities significantly increased due to **$17.0 million** in capital expenditures for construction in progress, primarily for the new manufacturing facility in Costa Rica[40](index=40&type=chunk)[198](index=198&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the debt refinancing with Oaktree, revenue by geography, and progress on U.S. clinical trials - The company is pursuing regulatory approval in the United States for its Motiva Implants and submitted the second module of its PMA application in May 2022[45](index=45&type=chunk) Revenue by Geographic Market (Six Months Ended June 30, in thousands) | Region | 2022 | 2021 | | :--- | :--- | :--- | | Europe | $27,705 | $27,219 | | Latin America | $26,367 | $15,171 | | Asia-Pacific/Middle East | $25,030 | $19,225 | | Other | $540 | $715 | | **Total** | **$79,642** | **$62,330** | - On April 26, 2022, the company entered into a new credit agreement with Oaktree for up to **$225 million** and drew an initial **$150 million**, which was used to repay the **$65 million** Madryn debt[112](index=112&type=chunk)[117](index=117&type=chunk)[162](index=162&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong revenue growth, the impact of debt refinancing, and key strategic investments - Revenue for the six months ended June 30, 2022, **increased by 27.8% to $79.6 million** compared to the same period in 2021, driven by market share gains and pandemic recovery[150](index=150&type=chunk)[183](index=183&type=chunk) - The company secured a new credit agreement with Oaktree for up to **$225 million**, drawing an initial **$150 million** to repay its previous **$65 million** Madryn debt and fund operations[151](index=151&type=chunk)[162](index=162&type=chunk)[201](index=201&type=chunk) - Full enrollment of the U.S. IDE clinical trial for Motiva implants was completed, with an estimated total trial cost between **$30.0 million and $40.0 million** over ten years[151](index=151&type=chunk)[159](index=159&type=chunk) - The company is expanding its manufacturing capacity in Costa Rica and exercised its option to purchase the land and building shell for approximately **$12.6 million**[153](index=153&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk profile remained materially unchanged during the reporting period - There were **no material changes** to the company's market risk profile during the quarter[206](index=206&type=chunk) [Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective due to a persistent material weakness in internal financial reporting controls - Management concluded that disclosure controls and procedures were **not effective** as of June 30, 2022[207](index=207&type=chunk) - A **material weakness** in internal control over financial reporting related to user access control deficiencies and lack of segregation of duties persists[208](index=208&type=chunk) - The company is actively working on a remediation plan for the material weakness and expects to implement changes before the end of fiscal year 2022[209](index=209&type=chunk) Part II. Other Information [Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not currently involved** in any material legal proceedings[215](index=215&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) Key risks include pandemic impacts, FDA approval uncertainty, supplier reliance, and industry-specific safety concerns - The **COVID-19 pandemic** continues to pose a risk by causing deferral of elective procedures and disrupting supply chains[217](index=217&type=chunk)[220](index=220&type=chunk) - Obtaining **FDA approval** for Motiva Implants in the U.S. is a primary goal but is a costly, time-consuming, and uncertain process[224](index=224&type=chunk) - The company relies on **NuSil as the sole supplier** for its primary raw material, medical-grade silicone, creating significant supply chain risk[264](index=264&type=chunk) - **Negative publicity** and regulatory actions concerning breast implant safety, particularly regarding BIA-ALCL, could adversely affect the business[246](index=246&type=chunk)[249](index=249&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=93&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - There were **no unregistered sales** of equity securities[317](index=317&type=chunk) [Defaults Upon Senior Securities](index=93&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon its senior securities - There were **no defaults** upon senior securities[317](index=317&type=chunk) [Other Information](index=93&type=section&id=Item%205.%20Other%20Information) No other material information was required to be disclosed for the period - There is **no other information** to report[317](index=317&type=chunk) [Exhibits](index=93&type=section&id=Item%206.%20Exhibits) Filed exhibits include a key supplier agreement, equity award forms, and required officer certifications - Exhibits filed include the Master Supply Agreement with Nusil Technology LLC, various equity incentive plan agreements, and required CEO/CFO certifications[316](index=316&type=chunk)

Establishment Labs Holdings, Inc. (NASDAQ:ESTA) Q1 2022 Earnings Conference Call May 9, 2022 4:30 PM ET Company Participants Juan Jose Chacon Quiros - Founder, Chief Executive Officer & Executive Director Rajbir Denhoy - Chief Financial Officer Conference Call Participants Josh Jennings - Cowen Philip Coover - Goldman Sachs Marie Thibault - BTIG Chris Cooley - Stephens Zach Weiner - Jefferies Operator Good afternoon. Welcome to Establishment Labs First Quarter 2022 Earnings Call. [Operator Instructions] As ...

Part I [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Q1 2022, including balance sheets, operations, and cash flows, reporting **$38.5 million** revenue and a **$5.9 million** net loss [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2022, total assets were **$141.6 million**, total liabilities **$93.7 million**, and cash decreased to **$44.7 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $44,656 | $53,415 | | Total Current Assets | $110,016 | $113,271 | | Total Assets | $141,556 | $139,529 | | **Liabilities & Equity** | | | | Total Current Liabilities | $36,510 | $31,889 | | Total Liabilities | $93,721 | $88,790 | | Total Shareholders' Equity | $47,835 | $50,739 | | Total Liabilities & Equity | $141,556 | $139,529 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2022, revenue increased **26.8%** to **$38.5 million**, gross profit rose to **$24.9 million**, but a higher operating loss of **$5.6 million** resulted in a net loss of **$5.9 million** Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Revenue | $38,452 | $30,336 | | Gross Profit | $24,936 | $20,090 | | Total Operating Expenses | $30,511 | $22,186 | | Loss from Operations | $(5,575) | $(2,096) | | Net Loss | $(5,933) | $(6,948) | | Basic and Diluted Net Loss per Share | $(0.24) | $(0.29) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For Q1 2022, net cash used in operating activities was **$4.8 million**, investing activities **$5.7 million**, leading to a net decrease in cash of **$8.8 million**, with the balance at **$44.7 million** Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,840) | $(6,554) | | Net cash used in investing activities | $(5,739) | $(1,532) | | Net cash provided by financing activities | $1,695 | $1,786 | | **Net decrease in cash** | **$(8,759)** | **$(6,573)** | | **Cash at end of period** | **$44,656** | **$77,950** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, revenue by geography, debt agreements, and a significant subsequent debt refinancing event in April 2022, while pursuing U.S. FDA approval Revenue by Geographic Market (in thousands) | Region | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Europe | $14,339 | $12,693 | | Latin America | $12,186 | $8,001 | | Asia-Pacific/Middle East | $11,620 | $9,495 | | Other | $307 | $147 | | **Total** | **$38,452** | **$30,336** | - The company relies on NuSil Technology, LLC as the sole supplier of medical-grade silicone, with purchases from NuSil amounting to **$7.3 million** in Q1 2022, representing **31.4%** of total purchases[49](index=49&type=chunk) - Subsequent Event: On April 26, 2022, the company entered into a new Credit Agreement for up to **$225 million**, with an initial tranche of **$150 million** used to repay the outstanding **$65.0 million** Madryn Credit Agreement in full[109](index=109&type=chunk)[137](index=137&type=chunk)[140](index=140&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=37&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a **26.8% revenue increase** to **$38.5 million** for Q1 2022, rising operating expenses, and a new **$225 million** credit facility to support operations and U.S. market entry [Results of Operations](index=41&type=section&id=Results%20of%20Operations) This sub-section compares Q1 2022 and 2021 financial results, showing **26.8% revenue growth** to **$38.5 million**, a slight gross margin decrease, and significant increases in SG&A expenses Key Operational Metrics Comparison (in thousands) | Metric | Q1 2022 | Q1 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | $38,452 | $30,336 | +26.8% | | Gross Profit | $24,936 | $20,090 | +24.1% | | SG&A Expense | $26,913 | $18,138 | +48.4% | | R&D Expense | $3,598 | $4,048 | -11.1% | | Net Loss | $(5,933) | $(6,948) | -14.6% | - The increase in SG&A was primarily due to a **$5.6 million** increase in personnel costs, a **$1.7 million** increase in consulting fees (partly for Sarbanes-Oxley compliance), and a **$0.6 million** increase in sales commissions[167](index=167&type=chunk) - Gross margin decreased to **64.8%** from **66.2%** year-over-year, primarily due to geographic mix shifting to Latin American markets and a **3.1%** negative impact from inventory obsolescence[166](index=166&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2022, the company had **$44.7 million** in cash and an accumulated deficit of **$212.3 million**, with a new **$225 million** credit facility secured in April 2022 to strengthen liquidity - Cash balance was **$44.7 million** as of March 31, 2022, compared to **$53.4 million** at December 31, 2021[175](index=175&type=chunk) - In April 2022, the company entered a new credit agreement for up to **$225 million** and repaid its existing **$65.0 million** Madryn debt, including a **$6.5 million** early repayment penalty[180](index=180&type=chunk) - Net cash used in operating activities for Q1 2022 was **$4.8 million**, an improvement from **$6.6 million** in Q1 2021[176](index=176&type=chunk)[177](index=177&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reported no material changes to its market risk during Q1 2022, referring to the detailed disclosure in its Annual Report on Form 10-K - No material changes to market risk were reported for the quarter ended March 31, 2022[184](index=184&type=chunk) [Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2022, due to a material weakness in internal control over financial reporting, with remediation underway - Disclosure controls and procedures were concluded to be ineffective as of March 31, 2022[185](index=185&type=chunk) - A material weakness related to user access control deficiencies and lack of segregation of duties, first reported for year-end 2021, persists[186](index=186&type=chunk) - A remediation plan is underway and is expected to be implemented prior to the end of fiscal 2022[187](index=187&type=chunk) Part II [Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings requiring disclosure under Regulation S-K - The company is not a party to any material legal proceedings[193](index=193&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) This section details numerous risks, including the costly and uncertain FDA approval process, reliance on a single-source supplier, intense competition, and a material weakness in internal controls [Risks Related to Development and Commercialization](index=51&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization) This sub-section highlights risks in product development and market entry, including costly and uncertain U.S. FDA approval for Motiva Implants and the need for accurate demand forecasting - The company's Motiva Implants are not currently approved for sale in the U.S., and obtaining FDA approval is a costly, time-consuming, and uncertain process that is critical for future growth[202](index=202&type=chunk) - The ability to accurately forecast customer demand and manage inventory is critical, as both shortages and oversupply could adversely impact financial results[210](index=210&type=chunk) [Risks Related to Business, Industry and Operations](index=57&type=section&id=Risks%20Related%20to%20Business%2C%20Industry%20and%20Operations) This sub-section outlines broad business risks, including a history of net losses, intense competition, potential negative publicity regarding breast implant safety, and global economic conditions - The company has a history of net operating losses, with an accumulated deficit of **$212.3 million** as of March 31, 2022, and expects to incur losses for the foreseeable future[214](index=214&type=chunk) - Negative publicity and regulatory actions regarding breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), linked to competitors' textured products, could reduce overall demand for breast implants[223](index=223&type=chunk) - The military conflict between Russia and Ukraine may adversely affect business in Europe; Russia and Ukraine accounted for **1.7%** of net revenue in Q1 2022[268](index=268&type=chunk) [Risks Related to Manufacturing and Third-Party Relationships](index=69&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20Other%20Third-Party%20Relationships) Key risks include reliance on a single-source supplier (NuSil) for medical-grade silicone and other single-source suppliers for components, creating manufacturing and operational dependencies - The company relies on NuSil as the sole supplier for medical-grade long-term implantable silicone, and an interruption from this supplier could adversely affect the business[240](index=240&type=chunk) - A substantial portion of sales are through exclusive distributors, and the company does not have direct control over their sales efforts or compliance with regulations[244](index=244&type=chunk) [Risks Related to Intellectual Property and Data Security](index=73&type=section&id=Risks%20Related%20to%20Intellectual%20Property%20and%20Data%20Security) The company faces risks related to protecting its intellectual property, potential infringement litigation, and vulnerabilities in internal computer systems that could lead to data security breaches and penalties - The company relies on trade secrets and patents, and the inability to protect this intellectual property could harm its competitive position[246](index=246&type=chunk)[247](index=247&type=chunk) - Internal computer systems are vulnerable to security breaches, and failure to protect sensitive personal data in compliance with laws like GDPR and HIPAA could result in significant penalties and harm the business[253](index=253&type=chunk)[254](index=254&type=chunk) [Risks Related to Ownership of Our Securities and Corporate Structure](index=84&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Securities) This section covers investor risks, including share price volatility, a material weakness in internal controls, and differing shareholder rights as a British Virgin Islands company - A material weakness in internal control over financial reporting was identified as of December 31, 2021, related to user access controls and segregation of duties[279](index=279&type=chunk)[281](index=281&type=chunk) - As a British Virgin Islands company, shareholder rights differ from U.S. law, potentially offering fewer protections and making it difficult to enforce civil liabilities against the company or its directors[282](index=282&type=chunk)[283](index=283&type=chunk)[284](index=284&type=chunk) [Other Information (Items 2, 3, 4, 5, 6)](index=89&type=section&id=Other%20Items) The company reports no unregistered sales of equity, no defaults, no mine safety disclosures, and lists exhibits filed with the report - No transactions or events were reported under Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults Upon Senior Securities), Item 4 (Mine Safety Disclosures), or Item 5 (Other Information)[291](index=291&type=chunk)

Financial Data and Key Metrics Changes - Total revenue for Q4 2021 was $35.3 million, reflecting a 31% growth year-over-year, with foreign currency changes reducing growth by approximately 3 percentage points [21][22] - Gross profit for the quarter was $24.2 million, representing a gross margin of 68.6%, up from 54.3% in Q4 2020, attributed to improved production volumes and a return to a more normalized geographic mix [23] - Net loss from operations for Q4 was $9.4 million, compared to a net loss of $8 million in the same period last year [27] Business Line Data and Key Metrics Changes - Direct sales accounted for approximately 44% of total revenue, while distributor sales made up the remainder [22] - The launch of the Joy program and the introduction of the Motiva Ergonomix2 implants are expected to enhance market positioning and patient satisfaction [12][13] Market Data and Key Metrics Changes - Sales in Europe comprised approximately 38% of global sales, with Asia Pacific and the Middle East at 24%, and Latin America making up the balance [22] - Brazil, the largest market, accounted for approximately 14.7% of total quarterly sales, indicating strong performance in Latin America [22] Company Strategy and Development Direction - The company aims to expand its market share through innovation in women's health and the introduction of new products and geographies [7][34] - Establishment Labs is preparing for entry into the U.S. and Chinese markets, which are the largest globally, and plans to launch Motiva Mia to open a new customer base in breast aesthetics [35][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2022 revenue guidance of $155 million to $165 million, representing a growth of 22% to 30% over 2021 [7][29] - The company is closely monitoring the pandemic's impact and expects to manage supply chain disruptions effectively [30][31] Other Important Information - The company has signed a nonbinding term sheet to refinance its existing credit facility, which is expected to support growth initiatives [28] - The establishment of a Women's Health Hub in Barcelona is aimed at enhancing direct-to-consumer marketing and patient advocacy efforts [11] Q&A Session Summary Question: Insights on Motiva Mia commercialization - Management highlighted the importance of surgeon education and the establishment of a Women's Health Hub to effectively market Motiva Mia and bring in new customers [38][39] Question: Operating expenses and growth guidance - Management indicated that operating expenses are expected to trend down as a percentage of revenue despite increased investments in new initiatives [42] Question: China market strategy - The company is excited about entering the Chinese market, leveraging successful strategies from South Korea, and plans to launch Motiva by the end of the year [45][46] Question: Impact of Allergan's exit from the market - Management noted that the exit of Allergan has created opportunities for market share expansion, particularly in Brazil, and emphasized ongoing medical education efforts [50] Question: U.S. launch preparations - The company is preparing for the U.S. launch by establishing necessary infrastructure and hiring key personnel while being judicious with spending [54] Question: Gradual revenue growth from new products - Management indicated that revenue from new product launches like Flora and Mia is expected to grow gradually, with a focus on ensuring successful market expansion [57]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38593 | --- | --- | --- | --- | --- | --- | --- | |-------------------------------------------------------------------- ...

Establishment Labs Holdings Inc. (NASDAQ:ESTA) Q3 2021 Earnings Conference Call November 9, 2021 8:30 AM ET Company Participants Raj Denhoy – Interim Chief Financial Officer Juan José Chacón Quirós – Chief Executive Officer Conference Call Participants Josh Jennings – Cowen Chris Cooley – Stephens Anthony Petrone – Jefferies Philip Caldwell Coover – Goldman Sachs Matt Taylor – UBS Operator Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Establishment Labs Third Quarter 2021 ...