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Establishment Labs Holdings Inc. (ESTA) is a medical technology company focused on improving patient safety and aesthetic outcomes in the breast aesthetics and reconstruction market. The company designs, manufactures, and sells advanced silicone gel-filled breast implants under its flagship product line, Motiva Implants. With a global presence, ESTA operates through exclusive distributors and direct sales channels, offering innovative solutions that prioritize safety and aesthetic performance.
- Motiva Implants - Offers silicone gel-filled breast implants designed with proprietary technologies such as SmoothSilk surface, Qid RFID technology, BluSeal visual barrier layer, and TrueMonobloc configuration to enhance safety, durability, and aesthetic outcomes.
Name | Position | External Roles | Short Bio | |
---|---|---|---|---|
Filippo Peter Caldini [document 0] Executive | Interim Chief Executive Officer | Filippo "Peter" Caldini has been leading ESTA as President since August 20, 2024 and assumed the role of Interim Chief Executive Officer on March 1, 2025, marking his commitment to the company’s strategic direction. He previously held executive roles, including CEO at Acreage Holdings Inc., demonstrating a strong background in leadership and operational excellence. | View Report → | |
Rajbir S. Denhoy [document 0] Executive | Chief Financial Officer | Rajbir S. Denhoy has served as the Chief Financial Officer of ESTA since December 2021, after previously serving as Interim CFO and as Head of Strategy and Investor Relations at the company. | ||
S. Ross Mansbach [document 0] Executive | General Counsel and Chief Compliance Officer | S. Ross Mansbach has been the General Counsel and Chief Compliance Officer at Establishment Labs since August 2022. He also served as Chief Human Resources Officer from April 2023 to August 2024. | ||
Ann Custin [document 5] Board | Director | Board of Directors Member at Mayne Pharma Group Ltd. (since March 2022) | Ann Custin has been a Director at Establishment Labs since July 2020 where she also chairs the Audit Committee and serves on the Compensation Committee. Previously, she held executive roles at Siemens Medical Solutions Inc., Scient'x, and Draeger Medical Systems. | |
Bryan Slotkin [document 2] Board | Director | Partner at PJT Partners since June 2018 | Bryan Slotkin has served as a Director on the Board of Establishment Labs Holdings Inc. since July 2020. He is also recognized as an Audit Committee financial expert with extensive financial industry experience, including his current role as Partner at PJT Partners since June 2018. | |
Edward Schutter [document 2] Board | Director | Board member at TerrAscend Corp.; Board member at Vitruvias Therapeutics; Board member at Intrance Medical | Edward Schutter has been a director at ESTA since September 2015 and brings extensive experience from his prior role as CEO of Arbor Pharmaceuticals (2010–2021) as well as senior leadership positions at Sciele Pharmaceuticals and Solvay Pharmaceuticals. | |
Juan José Chacón Quirós [document 1] Board | Board Member and Advisor | Juan José Chacón Quirós served as CEO of ESTA from 2013 until his retirement on March 1, 2025 and now contributes as a Board Member and Advisor, leveraging his extensive industry experience at ESTA and elsewhere. | ||
Leslie Gillin [document 4] Board | Director | Chief Growth Officer of Pagaya Technologies LTD ; Member of the Board of Directors at ComScore, Inc. | Leslie Gillin has served as a director of ESTA since December 2020, and she currently chairs the Nominating and Corporate Governance Committee. She brings over 25 years of senior executive leadership experience from major institutions including Bank of America, Citi, and JPMorgan Chase. | |
Nicholas Lewin [document 2] Board | Chairman of the Board of Directors | Managing Partner at Crown Predator Holdings; Director at Allurion Technologies, Inc.; Director at Cutera Inc.; Director at GameSquare Holdings, Inc.; Director at Halo Maritime Defense Systems; Director at FaZe Holdings Inc.; Director at Dura Medic, LLC | Nicholas Lewin has been with ESTA since September 2015 as a board member and assumed the role of Chairman of the Board in December 2017, leveraging a diverse background including his long-standing position as Managing Partner at Crown Predator Holdings and multiple board roles in other organizations. |
- Considering the U.S. launch has generated strong order volumes with a conservative $5 million first-quarter target, what are the key risks or assumptions that management believes could derail achieving the $35 million U.S. revenue guidance for 2025?
- With SG&A expenses significantly increasing due to the U.S. commercial ramp-up, can you clarify which cost elements are one-time investments versus ongoing expenses and how this will impact your margins moving forward?
- As management targets EBITDA positive in the second half of 2025 and cash flow positive in 2026, what specific operational and financial milestones must be met to ensure these turnaround points, and what are the contingency plans if these are delayed?
- In light of the pending FDA submissions for significant products like Preserve and the reconstruction indication, what regulatory hurdles remain, and how could potential delays in approvals affect your long-term innovation pipeline and revenue expansion?
- Given the mixed performance in global markets—such as flat revenues in Latin America and evolving dynamics in China—how does management plan to adjust resource allocation or strategy if the expected mid-single-digit OUS growth fails to materialize?
Competitors mentioned in the company's latest 10K filing.
Company | Description |
---|---|
Allergan Aesthetics | A division of AbbVie, this competitor is part of the relatively concentrated U.S. market for silicone breast implants. It has regulatory approval to market and sell products in countries where the company currently does not, notably the United States. Additionally, it has conducted large prospective clinical studies starting in 1998, which are extensively used to promote its products. This competitor may also offer pricing programs with discounts across its non-breast aesthetic product portfolios. |
Mentor Worldwide LLC | A division of Johnson & Johnson, this competitor is part of the concentrated U.S. market for silicone breast implants. It has conducted large prospective clinical studies starting in 2000, which are extensively used to promote its products. This competitor also has regulatory approval to market and sell products in countries where the company currently does not, including the United States. |
Sientra Inc. | Recently acquired by Tiger Aesthetics Medical, this competitor is part of the concentrated U.S. market for silicone breast implants. It has conducted large prospective clinical studies starting in 2002, which are extensively used to promote its products. This competitor also has regulatory approval to market and sell products in countries where the company currently does not, including the United States. |
GC Aesthetics plc | This competitor operates in the international market for silicone breast implants, which is more fragmented compared to the U.S. market. |
Silimed, Inc. | This competitor is part of the fragmented international market for silicone breast implants. |
Groupe Sebbin SAS | This competitor operates in the fragmented international market for silicone breast implants. |
Hans Biomed Corp. | This competitor is part of the fragmented international market for silicone breast implants. |
Polytech Health & Aesthetics | This competitor operates in the fragmented international market for silicone breast implants. |
Arion Laboratories | This competitor is part of the fragmented international market for silicone breast implants. |
Notable M&A activity and strategic investments in the past 3 years.
Company | Year | Details |
---|---|---|
Motiva Benelux BV | 2024 | Acquired on October 1, 2024 by European Distribution Center Motiva BV, a wholly owned subsidiary of Establishment Labs Holdings Inc. The deal involves an initial cash payment of $0.2M, followed by common share payments of $1.2M and $3.0M, with additional contingent and true-up payments based on revenue and operational expense targets; the target is a distribution company in Belgium. |
Motiva NL B.V. | 2024 | Acquired on October 1, 2024 by European Distribution Center Motiva BV. The acquisition features a similar multi-part payment structure—an initial $0.2M cash payment, subsequent $1.2M and $3.0M in common shares, and later contingent and true-up payments based on performance metrics—for a distribution company in the Netherlands. |
Recent press releases and 8-K filings for ESTA.
- Peter Caldini is confirmed as permanent CEO effective May 7, 2025 and named as a Class II director effective May 24, 2025 with his term expiring at the 2026 AGM; there is no change in his compensation .
- Q1 2025 revenue reached $41.4 million with a gross margin of 67.2%, including $6.2 million in U.S. sales, alongside a net loss of $20.7 million .
- The company maintained its full-year revenue guidance at $205–210 million, aiming for sequential growth, margin improvements, and the first positive EBITDA quarter in H2 2025 .
- The firm launched its new minimally invasive product, Preservé .
- Preliminary Q1 2025 revenue is approximately $41.4 million, including $6.2 million from US Motiva sales.
- The company announced an investor day on June 12, 2025 in New York City to update on the US launch, innovation roadmap, and pipeline strategy.
- Guidance for full-year 2025 remains at $205 to $210 million, with minimal impact from tariffs and strong US market momentum noted.
- Achieved $44.5 million in Q4 2024 revenue (up 41% YoY) with full‐year sales of $166 million and reaffirmed 2025 revenue guidance of $205–210 million .
- Improved operational performance with net loss from operations reduced to $18.7 million (down from $22.1 million) and adjusted EBITDA loss improved to $13.1 million, aided by a $12.5 million reduction in operating expenses .
- Drove U.S. market momentum by launching Motiva Implants, generating $3.3 million in Q4 sales, onboarding over 650 accounts, and expanding capacity with a new third shift; Q1 2025 projections target U.S. revenue of approximately $5.5 million and a $35 million pipeline .
- Accelerating global expansion with the Preservé platform—launched in Brazil with upcoming deployments in Europe and Japan—alongside innovative, minimally invasive platforms: Mia, Preservé, and Ergonomix2 .
- Closed Q4 2024 with $90.3 million in cash, underscoring financial strength .