Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $41.4 million, an increase of 11% year-over-year, with a 13.5% growth excluding foreign exchange impacts [25][27] - Gross profit for Q1 was $27.8 million, representing 67.2% of revenue, a 160 basis point increase from 65.6% in Q1 2024 [27] - Adjusted EBITDA loss was $12.1 million, an improvement from a $13.1 million loss in the previous quarter [29] - Cash position as of March 31 was $69.2 million, with an additional $25 million available under a credit facility, totaling approximately $94 million in accessible cash [29][30] Business Line Data and Key Metrics Changes - U.S. revenue for Q1 was $6.2 million, exceeding the previous guidance of $5.5 million [10][25] - Outside the U.S., revenue growth was approximately 5% in Q1, in line with expectations [26][27] - The launch of Motiva in the U.S. has seen over 900 accounts onboarded, with 84% of those placing reorders [12][14] Market Data and Key Metrics Changes - The U.S. market is showing strong adoption, with daily orders exceeding 120 in April, up from 100 in March [13] - Brazil's revenue stabilized in Q1, but still showed a meaningful reduction compared to the same period last year [26] - The company is experiencing challenges in Latin America, particularly in Brazil, but has seen stabilization in other regions [41] Company Strategy and Development Direction - The company aims to become the market share leader in the U.S. and is focused on driving growth, increasing efficiency, and advancing its innovation pipeline [14][34] - The introduction of minimally invasive products like Mia and Preserve is expected to expand market opportunities and enhance patient outcomes [20][21][23] - The company is committed to achieving profitability and cash flow targets without the need for additional equity raises [30][31] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the revenue guidance of $205 million to $210 million for 2025, representing a growth of 23% to 26% [30][31] - There has been no observed impact on demand from recent trade policies, and the company is prepared to adjust expenses if necessary [31] - The company expects to reach cash flow breakeven in 2026, with a significant reduction in cash use anticipated throughout 2025 [30] Other Important Information - The appointment of Peter Caldini as permanent CEO was announced, with a focus on achieving the financial potential of the company [5][6] - The partnership with Meghan Trainor has generated over 4 billion impressions, significantly enhancing brand awareness [18][19] Q&A Session Summary Question: OUS outlook and consumer sentiment by region - Management confirmed mid-single digit growth guidance for OUS markets, with stabilization in Asia and Europe, while Brazil remains challenging [39][40] Question: Details on the launch of Preserve - The response to Preserve has been strong, positioned for day-to-day use, and expected to expand market share [42][43] Question: U.S. launch strategy and competitive response - The U.S. launch is exceeding expectations, with a conservative approach to guidance despite strong performance [49][50][54] Question: U.S. sales force expansion plans - The current sales force consists of 40 reps, with plans to expand in key markets as needed [57][58] Question: Gross margin outlook and tariff impact - Gross margins are expected to improve as U.S. sales grow, with minimal impact from tariffs anticipated [81][84] Question: Account penetration and market share expectations - The company aims for close to 100% penetration in engaged clinics, with expectations of achieving dominant market share over time [85][92]

Financial Performance - Establishment Labs Holdings Inc. announced preliminary revenue for Q1 2025, with specific figures to be detailed in the press release[4] - The company emphasizes that the preliminary financial estimates are forward-looking and may differ from actual results, cautioning against undue reliance on this information[6] - The financial information has not been audited or reviewed by the independent registered public accounting firm, CBIZ, Inc.[6]

Company Overview - Establishment Labs is a global medical device company focused on improving women's health and wellness in breast aesthetics and reconstruction through science, engineering, and technology [6] - The company has delivered over four million Motiva® devices to plastic and reconstructive surgeons since 2010, establishing a new standard for safety and patient satisfaction [6] Product Innovation - Motiva Implants® feature the patented SmoothSilk® surface, which enhances biocompatibility and promotes low inflammation, resulting in an industry low capsular contracture rate of 0.5% [1][2] - The implants are designed to adapt to body position changes, maintaining a round shape when lying down and a teardrop shape when standing [1] - Both Motiva SmoothSilk Ergonomix® and SmoothSilk® Round implants aim to provide a natural look and feel while ensuring a high safety profile, with less than 1% device-related complications reported [1][2] Market Presence - Motiva Implants® became available in the US in October 2024, with rapid adoption by top plastic surgeons across the country [2][3] - The company holds over 200 patent applications in 20 separate patent families worldwide, supported by over 100 clinical and scientific studies [2][6] Customer Satisfaction - The implants have achieved over 97% satisfaction rates among patients and surgeons, indicating strong acceptance and positive outcomes [1][2]

Financial Position - As of December 31, 2024, the company had an accumulated deficit of $444.7 million and cash of $90.3 million, compared to $40.0 million in 2023[409]. - As of December 31, 2024, total material cash requirements were estimated at $282.4 million, including debt obligations and future lease payments[420]. - The company has outstanding debt obligations of $221.4 million under a Credit Agreement, with interest rates of 9% for the first two tranches and 10% for the third[422]. - Cash balances increased to $90.3 million as of December 31, 2024, from $40.0 million in 2023[445]. Operating Activities - The net cash used in operating activities for 2024 was $58.5 million, with a net loss of $84.6 million, while in 2023, it was $88.5 million with a net loss of $78.5 million[415][416]. - Cash flows from operating activities showed a decrease in cash of $50.3 million in 2024, compared to a decrease of $26.3 million in 2023[414]. Investing Activities - Net cash used in investing activities for 2024 was $15.6 million, primarily for purchases related to a new manufacturing facility, compared to $24.5 million in 2023[417]. Financing Activities - Net cash provided by financing activities in 2024 was $125.9 million, mainly from a public offering and borrowings under the Credit Agreement, compared to $86.2 million in 2023[418][419]. - The company completed a registered direct offering in November 2024, resulting in net proceeds of approximately $49.7 million[411]. Future Outlook - The company expects to continue generating losses in the near term and may need to raise additional capital to execute its business plan[409][413]. - Future capital requirements will depend on market adoption of products, regulatory activities, and costs associated with R&D and commercialization[413]. Research and Development - R&D costs include personnel, materials, clinical expenses, and consulting services, expensed as incurred[431]. Inventory and Obsolescence - Inventory obsolescence provision recorded was $4.2 million as of December 31, 2024, compared to $3.9 million in 2023[435]. Foreign Currency Impact - Foreign currency transaction loss for the year ended December 31, 2024, amounted to $8.8 million, compared to a gain of $1.8 million in 2023[441]. - An immediate 10% adverse change in foreign exchange rates would impact revenues by approximately 2.4% and net loss by a similar amount[446]. - The company has not engaged in any foreign currency hedging activities, reassessing its approach as international operations grow[446]. Tax and Impairment - No material uncertain tax positions were recorded as of December 31, 2024, and 2023[440]. - There were no impairment charges or changes in estimated useful lives for long-lived assets during the years ended December 31, 2024, and 2023[436]. Inflation and Compensation - Inflation did not significantly impact the results of operations for any periods presented in the consolidated financial statements[447]. - Share-based compensation expense is recognized ratably over the requisite service period based on fair value at grant date[442].

Financial Data and Key Metrics Changes - Revenue for Q4 2024 totaled $44.5 million, a 41% increase from the previous year [56] - Full year sales reached $166 million, with guidance for 2025 set between $205 million and $210 million, representing a 25% growth over 2024 [9][64] - EBITDA loss improved to $13.1 million in Q4 2024 from $17.4 million in the same quarter last year [12][60] - Total operating expenses for 2024 decreased by $12.5 million compared to 2023 [11][61] - Cash position at the end of Q4 2024 was $90.3 million, up from $39.7 million at the end of Q3 2024 [62] Business Line Data and Key Metrics Changes - US sales totaled $3.3 million in the first two months post-launch, exceeding expectations [10] - Global demand remains uneven, with market share gains noted despite a low in aesthetic demand [12][14] - Operating expenses in the US increased due to the ramp-up of commercial activities following the approval of Motiva implants [58] Market Data and Key Metrics Changes - Sales distribution: EMEA accounted for 38%, Asia Pacific 35%, Latin America 18%, and North America 9% of total sales [57] - Latin America showed flat revenue in Q4 2024 compared to the previous year, indicating stabilization [14] - The Asia Pacific region is recovering from a downturn experienced in the second half of 2023 [13] Company Strategy and Development Direction - The company aims to achieve EBITDA positivity by the end of 2025 and cash flow positivity in 2026 [55][64] - Focus on expanding the US market is critical, with plans to increase the number of sales representatives and accounts [16][120] - New product launches, including Mia and Preservé, are expected to drive future growth and market expansion [32][39] Management's Comments on Operating Environment and Future Outlook - Management acknowledges ongoing macroeconomic pressures but remains optimistic about growth in EMEA and APAC [82][83] - The company expects mid-single-digit growth in international markets, excluding the US [64] - The launch of Motiva has generated significant interest, with over 1.8 billion impressions from organic social media activity [22][120] Other Important Information - The CEO announced retirement effective March 1, 2025, transitioning to a role focused on innovation and surgeon engagement [68][70] - The company has completed the acquisition of its distributor in Benelux, aiming for operational synergies [54] Q&A Session Summary Question: Update on US Motiva launch dynamics and account numbers - The company has onboarded 650 accounts, with 450 placing orders and 88% reordering [78] Question: Macro environment impact on aesthetics - Management noted microeconomic pressures but indicated signs of stabilization in Latin America and growth potential in EMEA and APAC [82][83] Question: US launch revenue target rationale - The initial $5 million target for Q1 was set conservatively to allow for early launch dynamics [87] Question: Operating expense trajectory - Operating expenses are expected to stabilize as the company leverages its established US commercial operation [91] Question: Regulatory pathway for Femtech products - The company is in the process of registering tools for Preservé and anticipates significant developments in the coming years [96][99] Question: Confidence in reaching $500 million revenue target - Management expressed confidence in achieving strong growth with a focus on profitability, emphasizing the importance of innovation [101][104]

Financial Data and Key Metrics Changes - Revenue for Q4 2024 totaled $44.5 million, a 41% increase from the previous year [56] - Full year sales reached $166 million, with guidance for 2025 set between $205 million and $210 million, indicating a 25% growth over 2024 [9][64] - EBITDA loss improved to $13.1 million in Q4 2024 from $17.4 million in the same quarter last year [12][60] - Total operating expenses for 2024 decreased by $12.5 million compared to 2023 [11][61] - Cash position at the end of Q4 2024 was $90.3 million, up from $39.7 million at the end of Q3 2024 [62] Business Line Data and Key Metrics Changes - US sales for the first two months of the launch reached $3.3 million, exceeding initial expectations [10] - Global demand remains uneven, with market share gains noted despite a low in aesthetic demand [12][14] - Operating expenses in the US increased due to the ramp-up of commercial activities following the approval of Motiva implants [58] Market Data and Key Metrics Changes - Sales distribution: EMEA accounted for 38%, Asia Pacific 35%, Latin America 18%, and North America 9% of total sales [57] - Latin America showed flat revenue in Q4 2024 compared to the previous year, indicating stabilization [14] - The Asia Pacific region is recovering from a downturn experienced in the second half of 2023 [13] Company Strategy and Development Direction - The company aims to achieve EBITDA positivity by the end of 2025 and cash flow positivity in 2026 [55][64] - Focus on expanding the US market, with plans to increase the number of sales representatives and onboard new accounts [16][120] - Introduction of new products like Mia and Preservé is expected to drive market expansion and revenue growth [32][39] Management's Comments on Operating Environment and Future Outlook - Management acknowledges ongoing macroeconomic pressures but remains optimistic about growth in EMEA and APAC [82][83] - The company expects mid-single-digit growth in international markets, excluding the US [64] - Management is confident in achieving revenue targets despite potential currency impacts [65] Other Important Information - The company is working on regulatory approvals for new products, including Preservé and the Ergonomix2 platform [28][99] - A partnership with a celebrity is anticipated to enhance brand visibility and support growth [25][121] - The transition of leadership is underway, with the founder stepping down as CEO but remaining involved in innovation and community engagement [68][70] Q&A Session Summary Question: Update on US Motiva launch dynamics and account numbers - The company has onboarded 650 accounts, with 450 placing orders and nearly 90% reordering [78] Question: Macro environment impact on aesthetics in key regions - Management noted that while Latin America is not expected to grow, EMEA and APAC show signs of recovery [82] Question: Clarification on US launch revenue targets - The $35 million target does not include new approvals in the US [80] Question: Trajectory of operating expenses and SG&A - SG&A expenses are expected to stabilize as the company leverages its established US commercial operation [91] Question: Regulatory pathway for Femtech products - The company is in the process of registering tools necessary for Preservé and anticipates significant innovation in the coming years [96][99] Question: Confidence in reaching $500 million revenue target - Management believes that with the US market onboard and a strong innovation pipeline, achieving this target as a profitable company is feasible [105]

Financial Performance - Establishment Labs Holdings Inc. reported a quarterly loss of $0.98 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.62, and compared to a loss of $0.79 per share a year ago, indicating a significant earnings surprise of -58.06% [1] - The company posted revenues of $44.51 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 0.64%, but showing an increase from year-ago revenues of $31.56 million [2] - The current consensus EPS estimate for the upcoming quarter is -$0.54 on revenues of $43.43 million, and for the current fiscal year, it is -$1.83 on revenues of $207.11 million [7] Market Performance - Establishment Labs shares have declined approximately 22.3% since the beginning of the year, contrasting with the S&P 500's gain of 1.3% [3] - The company has surpassed consensus EPS estimates two times over the last four quarters, while also topping consensus revenue estimates two times in the same period [2] Industry Outlook - The Medical Services industry, to which Establishment Labs belongs, is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% of industries [8] - The earnings outlook and estimate revisions trend for Establishment Labs is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expectations of underperformance in the near future [6]

Financial Performance - Fourth quarter revenue was $44.5 million, a 41% increase from $31.6 million in the same period of 2023[5]. - Fourth quarter net loss from operations was $18.7 million, a 15% reduction compared to a net loss of $22.1 million in the year-ago period[4]. - Adjusted EBITDA loss for the fourth quarter improved to $13.1 million, a 25% reduction from a loss of $17.4 million in the same quarter last year[4]. - The company reaffirmed 2025 revenue guidance of $205 million to $210 million, representing a 23% to 26% increase over 2024[4]. - Net loss for the year ended December 31, 2024, was $84.596 million, compared to a net loss of $78.502 million in 2023, indicating a deterioration of 8%[25]. - Adjusted EBITDA improved to a loss of $28.251 million in 2024 from a loss of $47.035 million in 2023, showing a 40% reduction in losses[25]. Cash and Assets - Cash balance as of December 31, 2024, was $90.3 million, with an additional $25 million available from a credit facility, totaling approximately $115 million[4]. - Total assets increased to $346.831 million in 2024, up from $268.641 million in 2023, representing a growth of 29%[24]. - Current assets rose to $243.037 million in 2024, compared to $174.901 million in 2023, reflecting an increase of 39%[24]. - Cash reserves significantly increased to $90.347 million in 2024, compared to $40.035 million in 2023, which is a growth of 126%[24]. Expenses - Sales, general and administrative expenses increased to $44.0 million, up from $36.9 million in the fourth quarter of 2023[7]. - Research and development expenses decreased to $5.1 million, down from $5.8 million in the same quarter a year ago[8]. - Interest expense for the year ended December 31, 2024, was $20.829 million, up from $15.393 million in 2023, indicating an increase of 36%[25]. Inventory and Equity - Inventory decreased slightly to $78.766 million in 2024 from $79.471 million in 2023, a decline of 0.9%[24]. - Total shareholders' equity increased to $53.095 million in 2024, compared to $18.395 million in 2023, representing a growth of 189%[24]. Product Development - U.S. sales of Motiva implants reached $3.3 million in the fourth quarter, with expectations of approximately $5.5 million in the first quarter of 2025[4]. - The company launched Preservé in Brazil, expanding its minimally invasive technology portfolio[4]. Liabilities - Total liabilities increased to $293.736 million in 2024, up from $250.246 million in 2023, marking a rise of 17%[24]. - Goodwill rose to $1.209 million in 2024 from $465 million in 2023, reflecting a substantial increase of 160%[24].

Financial Performance - Revenue for the nine months ended September 30, 2024, was $121.5 million, a decrease of $12.1 million or 9.1% compared to $133.6 million in the same period of 2023[120] - Net losses for the nine months ended September 30, 2024, were $50.1 million, compared to $58.0 million for the same period in 2023[120] - Revenue increased by $1.7 million, or 4.4%, to $40.2 million for the three months ended September 30, 2024, compared to $38.5 million for the same period in 2023[137] - Net loss for the three months ended September 30, 2024, was $16.7 million, compared to a net loss of $29.3 million for the same period in 2023[136] - Revenue decreased by $12.1 million, or 9.1%, to $121.5 million for the nine months ended September 30, 2024, compared to $133.6 million for the same period in 2023[148] - The net loss for the nine months ended September 30, 2024, was $50.1 million, influenced by changes in operating assets and liabilities[159] Cash and Liquidity - As of September 30, 2024, the accumulated deficit was $410.2 million, with a cash balance of $39.7 million[120] - The company had cash of $39.7 million as of September 30, 2024, compared to $40.0 million as of December 31, 2023[155] - The company reported a net cash used in operating activities of $37.8 million for the nine months ended September 30, 2024, compared to $80.4 million for the same period in 2023[159] - The company generated $51.4 million in net cash from financing activities for the nine months ended September 30, 2024, mainly from the issuance of common shares and pre-funded warrants[162] - The company anticipates that available cash and cash from operations will be sufficient to meet liquidity requirements for at least the next 12 months[157] - As of September 30, 2024, the company had $196.4 million in outstanding principal under its term loan[130] - As of September 30, 2024, the outstanding amount under the Credit Agreement was $196.4 million, including $21.4 million of accrued interest[164] Expenses and Cost Management - SG&A expenses decreased by $5.9 million, or 14.8%, to $34.1 million for the three months ended September 30, 2024, compared to $40.0 million for the same period in 2023[140] - R&D expenses decreased by $2.3 million, or 32.4%, to $4.8 million for the three months ended September 30, 2024, compared to $7.1 million for the same period in 2023[142] - SG&A expenses decreased by $12.9 million, or 11.9%, to $95.8 million for the nine months ended September 30, 2024, compared to $108.7 million for the same period in 2023[150] - Interest expense increased to $14.9 million for the nine months ended September 30, 2024, compared to $11.1 million for the same period in 2023[152] Product Development and Regulatory Approvals - The company received FDA approval for Motiva Implants in the United States in September 2024, and began sales in October 2024[121] - The company completed a clinical study for Mia Femtech, showing the ability to increase breast shape by 1 to 2 cups in a 15-minute procedure[121] - The construction of a new manufacturing facility in Costa Rica was completed in June 2024, increasing manufacturing capacity by approximately 730,000 units per year[121] - The company incurred approximately $56.0 million in costs for the construction of the new facility in Costa Rica[121] - The company incurred $5.9 million in costs for developing an enterprise resource planning system for the anticipated U.S. launch of Motiva Implants[161] Future Outlook - The company expects higher selling prices in the U.S. and the introduction of new products to positively impact gross margins in 2025[132] - The company expects to continue generating losses in the near term, with an accumulated deficit of $410.2 million as of September 30, 2024[155] - Future capital requirements will depend on market adoption of products, regulatory activities, and competition[157] - The company filed a Shelf Registration Statement with the SEC in April 2023, allowing for the potential raising of additional capital until April 2026[157] - The company may need to raise additional capital to execute its business plan, which could adversely affect its operations if not achieved[157]

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $40.2 million, an increase of 4.5% from the same period last year [12] - Gross profit for Q3 was $25.7 million, representing 63.9% of revenue, down from 67.7% in Q3 2023 [12] - EBITDA loss improved to $7 million from over $16 million in the previous year [6][13] - Cash loss in Q3 was $14.9 million, down more than 60% from the previous year [5][13] - Pro forma cash position at the end of Q3 was approximately $114 million after recent capital raises [5][14] Business Line Data and Key Metrics Changes - The launch of Motiva Implants in the U.S. exceeded expectations, with over 250 accounts onboarded and more than 70 placing orders within three weeks [7][8] - The company is signing up to 50 new accounts daily, with potential revenue of $3 million in the last two months of the quarter [8] - Mia Femtech is gaining traction, with 40% of women choosing it not seeking traditional breast augmentation [10] Market Data and Key Metrics Changes - Sales in Europe, Middle East, and Africa accounted for approximately 49% of total sales, while Asia Pacific contributed 27% and Latin America 24% [12] - Demand for breast procedures in Brazil is down as much as 50% in certain regions, impacting overall performance in Latin America [7][12] - Despite challenges in Latin America, the company is seeing growth in its OUS business, particularly in China [7] Company Strategy and Development Direction - The company aims to achieve its first positive EBITDA quarter in 2025, with a focus on U.S. growth initiatives and cost reductions [6][15] - The FDA approval of Motiva is seen as a significant growth opportunity, with expectations for revenue in the U.S. to exceed $35 million in 2025 [9][17] - The company is also focused on expanding Mia Femtech as a new category in breast aesthetics, with plans to increase the number of certified clinics [10][37] Management's Comments on Operating Environment and Future Outlook - Management noted that while the U.S. market is off to a strong start, underlying market demand remains uneven, particularly in Latin America [14][15] - The company is taking a conservative approach to budgeting for 2025, anticipating mid-single-digit growth outside the U.S. [15][46] - Management expressed confidence in the long-term growth potential in the U.S. market, driven by the introduction of innovative products [17][42] Other Important Information - The company has decommissioned one of its manufacturing facilities to streamline operations and reduce costs [5][9] - A strategic financing agreement in China aims to support the growth of Motiva and the development of new products [11][25] Q&A Session Summary Question: U.S. launch expectations and ramp-up - Management highlighted the quality of sales reps and the rapid onboarding of accounts as key factors for achieving $35 million in revenue next year [19][20] Question: Growth expectations for 2025 - Management clarified that the 5% growth expectation for OUS is conservative and reflects a cautious budgeting approach [21][22] Question: Progress in China - Management noted that while 2024 has been challenging, investments are expected to enhance growth in 2025 [24][25] Question: Market conditions in Europe and APAC - Management indicated that EMEA markets are stabilizing, while APAC shows potential for improvement [28][29] Question: Supply challenges and near-term demand - Management acknowledged short-term supply challenges due to the decommissioning of a manufacturing facility but expects to resolve these by Q1 [30] Question: U.S. account targets and sales force expansion - Management confirmed plans to increase the sales force as the number of accounts grows, emphasizing the need for quality over quantity [31][32] Question: Regulatory path for Mia and Ergonomix - Management is in discussions with the FDA regarding the regulatory pathway for Mia and Ergonomix2 [38][47]