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 January 12, 2026 Date of Report (date of earliest event reported) Establishment Labs Holdings Inc. (Exact name of registrant as specified in its charter) 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 Exc ...

About Establishment Labs Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women's health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The Company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 90 countries. With over four million Motiva® devices delivered to plastic and reconstructive surgeons since 2010, the Company's products have created a n ...

Core Insights - Establishment Labs (ESTA) has submitted its Motiva breast implants to the FDA for approval in primary and revision breast reconstruction, expanding its market beyond elective procedures [1][9] - The submission is part of the company's strategy to utilize existing clinical data and early commercial traction to enter a less innovation-heavy segment of breast care, potentially leading to more stable growth [2][4] Company Developments - If approved, the reconstruction indication could significantly enhance Establishment Labs' business by tapping into a reimbursement-backed market with steadier procedure volumes compared to elective augmentation [4] - ESTA's current market capitalization stands at $2.22 billion, with projected earnings growth of 54.84% for the next year [5] - The FDA submission is supported by a 274-patient IDE study conducted across 17 U.S. sites and one in Europe, evaluating the safety and performance of Motiva implants in post-mastectomy reconstruction [10][12] Product Details - The filing includes Motiva SmoothSilk Round and Ergonomix implants, which feature patented SmoothSilk surface technology for enhanced biocompatibility and reduced inflammatory response [11] - Since gaining FDA approval for breast augmentation in 2024, over 60,000 Motiva implants have been sold in the U.S., and the company has a commercial presence in reconstruction through the Motiva Flora tissue expander [12] Industry Outlook - The global breast implants market was estimated at $2.66 billion in 2024 and is projected to reach $5.16 billion by 2033, growing at a CAGR of 7.7% from 2025 to 2033, driven by rising demand for aesthetic procedures and technological advancements [13]

NEW YORK--(BUSINESS WIRE)--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 that it has submitted Motiva® implants for approval in primary and revision breast reconstruction to the U.S. Food and Drug Administration (FDA). The products were previously approved by the FDA for use in breast augmentation on September 27, 2024. "Expanding our FD. ...

Summary of Establishment Labs Holdings Conference Call Company Overview - Establishment Labs is a global medtech company focused on women's health, specifically in breast aesthetics and reconstruction, operating in 90 countries [4][5] - The company has recently entered the U.S. market after receiving FDA approval and has seen significant success in its first year [4] Core Product Differentiation - Establishment Labs claims to have the best implants in the industry, emphasizing safety and performance, with a device-related complication rate of less than 1% [5] - The proprietary SmoothSilk surface technology enhances biocompatibility and reduces inflammation, contributing to a superior safety profile [5] U.S. Market Performance - The company has established 1,300 accounts in the U.S. with increasing utilization rates and daily orders, indicating strong market penetration [10][13] - The expected market share by the end of the year is approximately 20%, which is considered impressive for the first year [13] Product Launches and Innovations - Upcoming product launches include the minimally invasive portfolio with Preservae in Q1 next year and the Recon Indication submission by the end of this year [5][11][28] - The Mia product is projected to generate $8 million to $10 million this year, with expectations of at least $30 million next year from the minimally invasive portfolio [16] Market Expansion Potential - The minimally invasive products are expected to expand the market significantly, with 40% of women undergoing the Mia procedure indicating they were not considering breast augmentation prior [19] - The company is focusing on direct markets, particularly in Western Europe, where it has seen over 20% growth in the last quarter [26][38] Financial Performance and Projections - Establishment Labs is EBITDA positive and aims to achieve cash flow positivity next year [21] - Gross margins have improved, crossing 70% in Q3, with expectations for continued growth as the U.S. market share increases [22][23] International Market Challenges - The macro environment in China is challenging, but the company is optimistic about achieving similar market share levels as in other Asian markets [32][34] - The company has seen competitors retracting from markets, which may present opportunities for further growth [34][35] Future Growth Opportunities - The JEM program, focused on gluteal augmentation, is expected to launch in Latin America around late 2026 or 2027, representing a significant future opportunity [40][41] - The company is leveraging its marketing strategies, including partnerships with brand ambassadors, to enhance brand recognition and drive growth [46][48] Conclusion - Establishment Labs is positioned for strong growth in the U.S. and international markets, driven by innovative products and a focused strategy on women's health. The company is optimistic about its future prospects, particularly with upcoming product launches and market expansion initiatives.

Company Overview - Establishment Labs Holdings Inc. (NASDAQ:ESTA) is a medical technology company focused on women's health, specializing in silicone-filled breast and body shaping implants [5]. Financial Performance - For fiscal Q3 2025, Establishment Labs reported revenue of $53.78 million, reflecting a year-over-year growth of 33.7% and surpassing estimates by $1.5 million [2]. - The company reported an EPS of negative $0.38, which exceeded expectations by $0.15 [2]. Market Dynamics - The revenue growth was driven by $11.9 million in sales of Motiva in the United States and strong performance in direct markets [2]. - The US business is identified as a critical growth segment, with a 16% increase in this market during a seasonally slower quarter for breast procedures, where overall market activity can decline by 20% to 30% [3]. Future Outlook - The fourth quarter is anticipated to be the strongest for breast augmentation, with sales acceleration already being observed in the US [4]. - Management expects to capture approximately 20% of the US breast augmentation market by the end of 2025 and to exceed previous guidance of $40 million in US Motiva sales [4].

Financial Performance - Revenue for the nine months ended September 30, 2025, was $146.5 million, an increase of $25.0 million or 20.6% compared to $121.5 million in the same period of 2024[226]. - Net losses for the nine months ended September 30, 2025, were $48.4 million, a slight improvement from $50.1 million in the prior year[226]. - Revenue for the three months ended September 30, 2025, increased by $13.6 million, or 33.8%, to $53.8 million compared to $40.2 million for the same period in 2024[262]. - Net loss for the three months ended September 30, 2025, was $11.1 million, compared to a net loss of $16.7 million for the same period in 2024[260]. - Gross profit for the three months ended September 30, 2025, was $37.7 million, with a gross margin of 70.1%, up from 63.9% in the same period in 2024[261][264]. - Gross margin for the nine months ended September 30, 2025, improved to 68.8% from 65.0% in the same period in 2024[275]. - SG&A expenses for the nine months ended September 30, 2025, rose by $25.2 million, or 26.3%, to $121.0 million compared to $95.8 million in 2024[277]. - Interest expense for the nine months ended September 30, 2025, was $18.0 million, an increase from $14.9 million in the same period in 2024[280]. Cash and Liquidity - As of September 30, 2025, the company had an accumulated deficit of $493.1 million and a cash balance of $70.6 million[226]. - As of September 30, 2025, the company had cash of $70.6 million, down from $90.3 million as of December 31, 2024[283]. - The company expects available cash and cash from operations to meet liquidity requirements for at least the next 12 months, covering operating expenses and interest payments[286]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $50.7 million, primarily due to a net loss of $48.4 million[290]. - The company reported a net cash increase of $(19.7) million for the nine months ended September 30, 2025, compared to $(0.3) million for the same period in 2024[289]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $37.8 million, with a net loss of $50.1 million[291]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $34.4 million, mainly from $24.5 million in borrowings under the Tranche D Term Loan[295]. - As of September 30, 2025, $246.4 million was outstanding under the Credit Agreement, with interest rates ranging from 9% to 10% per annum[299]. Product Development and Launches - The company received FDA approval for Motiva Implants in the United States in September 2024 and began sales in October 2024[225][232]. - A clinical study of Mia Femtech showed a 1% reoperation rate at 3 years, with 87% of patients reporting increased breast satisfaction[227]. - The company launched Preservé, a minimally invasive breast tissue-preserving technology, in Brazil in February 2025, with plans for further international launches[228]. - The company anticipates future capital requirements will depend on market adoption rates of its products, particularly the Motiva Implants[287]. - The company expects R&D expenses to remain elevated as it advances products under development and prepares for additional clinical studies[250]. Operational Developments - The new manufacturing facility in Costa Rica, completed in June 2024, is expected to increase production capacity by approximately 730,000 units per year[233]. - The company incurred approximately $56.0 million in costs for the construction of the new facility[233]. - The company incurred $4.2 million in property and equipment purchases as part of its investing activities for the nine months ended September 30, 2025[292]. - The company expects overall operating expenses to increase compared to 2024, while focusing on managing these expenses[258].

Core Insights - Establishment Labs Holdings Inc. is a key player in the medical technology sector, focusing on women's health, particularly breast aesthetics and reconstruction, with a price target of $70 set by Needham on November 6, 2025, indicating a potential increase of 7.84% from the current stock price of $64.91 [1] Financial Performance - The Q3 2025 earnings call revealed a quarterly loss of $0.38 per share, which was better than the Zacks Consensus Estimate of a $0.54 loss, resulting in a positive surprise of 29.63% [2][6] - Revenue for Q3 2025 was reported at $53.78 million, exceeding the Zacks Consensus Estimate by 3.45% and showing significant growth from $40.23 million in the same period last year, driven by Motiva product sales contributing $11.9 million [3][6] Market Position - Despite only exceeding consensus revenue estimates once in the last four quarters, the company demonstrated a 33.8% increase in revenue year-over-year, indicating strong market position and growth potential [4] - The stock has shown volatility, with a 52-week high of $65.10 and a low of $26.56, and the current market capitalization is approximately $1.88 billion, with a trading volume of 1,341,361 shares [5]

Core Insights - Establishment Labs Holdings Inc. reported a quarterly loss of $0.38 per share, which was better than the Zacks Consensus Estimate of a loss of $0.54, marking an earnings surprise of +29.63% [1] - The company generated revenues of $53.78 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 3.45% and showing a year-over-year increase from $40.23 million [2] - The stock has underperformed the market with a gain of about 7.2% since the beginning of the year, compared to the S&P 500's gain of 15.1% [3] Financial Performance - Over the last four quarters, Establishment Labs has surpassed consensus EPS estimates two times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.36 on revenues of $64.57 million, and for the current fiscal year, it is -$2.09 on revenues of $209.24 million [7] Industry Outlook - The Medical Services industry, to which Establishment Labs belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of Establishment Labs' stock may be influenced by the overall outlook of the industry [8]

Core Insights - Establishment Labs Holdings Inc. reported a significant Q3 2025, achieving a 34% increase in global revenue to $53.8 million, with U.S. revenue reaching $11.9 million, marking a 16% sequential growth [1][5][23] - The company achieved a gross profit margin of 70.1%, the first time exceeding 70%, and recorded positive EBITDA of $1.2 million, a milestone in its financial history [1][24][26] - The company anticipates reaching cash flow positive in 2026 and has raised its 2025 revenue guidance to exceed $210 million [6][30][31] Financial Performance - Total revenue for Q3 was $53.8 million, a 33.7% increase year-over-year, with U.S. sales contributing $11.9 million [23][24] - Gross profit for the quarter was $37.7 million, resulting in a gross margin of 70.1%, up from 63.9% a year ago [24][26] - Adjusted EBITDA was positive at $1.2 million, compared to losses in previous quarters, indicating improved operational efficiency [26][31] Market Growth and Strategy - The U.S. market is the primary growth segment, with expectations of capturing approximately 20% market share in the breast augmentation market by the end of 2025 [6][12][56] - The company is preparing for the launch of its breast reconstruction products, which are expected to mirror the market size of breast augmentation [7][18] - Direct markets outside the U.S. showed a 15% growth, with notable performances in Europe, particularly in the UK and Spain [19][20] Product Development and Innovation - Establishment Labs is focusing on its minimally invasive portfolio, with the PRESUVEY procedure showing promising early adoption among U.S. surgeons [15][21] - The company has trained over 1,300 surgeons on its Motiva implants, with a significant increase in procedures performed [8][10] - Surgeons report a 14.6% increase in procedures due to the introduction of Motiva, indicating strong market demand [12][14] Future Outlook - The company expects to maintain revenue growth of over 20% for several years, with profitability expected to expand at a faster rate [28][32] - Establishment Labs plans to continue expanding its commercial infrastructure in the U.S. while managing operating expenses effectively [27][30] - The anticipated launch of new products and the expansion of existing accounts are expected to drive further growth in 2026 [61][62]