The U.S. medical device market is filled with companies that have innovative technology, but my bullish outlook on Establishment Labs ( ESTA ) is not based solely upon the successful launch of the Motiva breast implantsI am an investor specializing in the consumer products sector with a focus on identifying companies that offer a unique combination of strong brand recognition, solid financials, and growth potential. I have a keen eye for consumer trends and an in-depth understanding of the industry, which h ...

The company reported adjusted earnings before interest and taxes of €580 million in the fourth quarter, shy of analyst expectations. ...

Baron Funds, an investment management company, released its “Baron Discovery Fund” fourth-quarter 2025 investor letter. A copy of the letter can be downloaded here. The Fund focuses on long-term, competitively positioned companies that are well-managed and have significant potential in untapped markets. The letter also addressed the advancements in AI and how humans define themselves in the changing landscape. In Q4, the fund generated a return of 0.19% (Institutional Shares), underperforming the Russell 2 ...

PresentationOkay. Thanks, everyone, for being here. I'm really excited to be introducing some of the management team from Establishment Labs. We're going to be starting off with a presentation from CEO, Peter Caldini, and then Raj Denhoy, CFO, will be joining us for some Q&A afterwards.Filippo CaldiniCEO & Director Great. Thank you. Thank you very much. It's a great pleasure to be here, really an opportunity to share some exciting news and exciting update on Establishment Labs. We just completed a very succ ...

Core Insights - The investment firm has demonstrated resilience in a challenging macroeconomic and geopolitical environment, achieving a 21% growth in assets under management (AuM) in 2025 [3] - The firm added $30.2 billion in total new assets, aligning with its guidance of $26 billion to $31 billion [3] - Fundraising reached $26 billion in 2025, marking the highest year for new client demand in the firm's 30-year history, representing a 22% increase from the previous year [3] - M&A activities contributed an additional $4 billion to the firm's growth [3] - Bespoke solutions accounted for 72% of inflows, with both mandates and evergreens achieving their strongest performance to date [3]

Summary of Establishment Labs FY Conference Call Company Overview - **Company**: Establishment Labs (NasdaqCM: ESTA) - **Industry**: Medical technology focused on breast aesthetics and reconstruction - **Market Presence**: Over 4.5 million devices sold in 90 countries, with a successful U.S. launch following FDA approval in late 2024 [2][6] Key Financial Highlights - **2025 Revenue Growth**: Achieved a 27% growth globally, with revenue between $210.5 million and $211.5 million [3][6] - **U.S. Market Performance**: Generated over $45 million in revenue in the first year of U.S. operations, capturing approximately 20% market share [9][6] - **Profitability**: Achieved EBITDA positive status in Q3 2025, with expectations to maintain this in Q4 and beyond [7][6] - **Cash Position**: Improved cash balance to $75.5 million at the end of 2025, a $5 million increase from Q3 2025 [7][6] Product Innovation and Market Strategy - **Unique Product Offering**: Motiva implants feature four patented technologies, including SmoothSilk, which enhances biocompatibility and reduces inflammation [4][5] - **Minimally Invasive Platform**: The launch of Preservae is expected to revolutionize the market, targeting a previously untapped segment of affluent women [11][16] - **Market Expansion**: Plans to add 15 sales representatives in 2026 to support growth in the augmentation space and prepare for the reconstruction indication [12][58] Marketing and Brand Awareness - **Marketing Success**: Achieved over 9.2 billion impressions in the first year, with notable celebrity endorsements driving brand awareness [10][11] - **Consumer Trends**: Increased openness about breast augmentation procedures, aided by social media and mainstream media coverage [20][21] Future Growth Drivers - **Reconstruction Indication**: Anticipated approval of the PMA supplement for reconstruction, which could double the addressable market in the U.S. [39][40] - **International Expansion**: Continued growth expected in Latin America, particularly in Mexico and Colombia, despite challenges in Brazil [45][46] - **APAC Market Strategy**: Plans to launch Preservae in Japan and South Korea in 2026, leveraging existing market share [47][48] Competitive Landscape - **Market Position**: Established a strong foothold in the U.S. market with minimal competitive response from larger players like J&J and Alcon [37][38] - **Sientra's Exit**: Noted that Sientra has de-emphasized its business, allowing Establishment Labs to capture market share more effectively [37][38] Financial Outlook - **Revenue Projections**: Expecting at least 25% growth in 2026 and 2027, driven by existing momentum and new product launches [23][31] - **Gross Margin Improvement**: Achieved over 70% gross margin, with expectations for further expansion as the minimally invasive platform is launched [23][56] Summary Establishment Labs is well-positioned for significant growth in the breast aesthetics and reconstruction market, driven by innovative products, effective marketing strategies, and a strong financial foundation. The company anticipates continued expansion in both domestic and international markets, with a focus on enhancing profitability and market share through strategic initiatives and product launches.

Financial Results - Establishment Labs Holdings Inc. announced preliminary unaudited financial results for the quarter and year ended December 31, 2025[5] - The independent registered public accounting firm, CBIZ, Inc., has not audited or reviewed the preliminary financial information[7] Cautionary Statements - The financial information provided is forward-looking and may differ materially from actual results, emphasizing the need for caution in reliance on these estimates[7]

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. ...