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]

Financial Performance - Establishment Labs Holdings Inc. reported a quarterly loss of $0.59 per share, which was better than the Zacks Consensus Estimate of a loss of $0.61, and an improvement from a loss of $1.12 per share a year ago, indicating a 47.3% year-over-year improvement [1] - The company posted revenues of $40.23 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 0.92%, but showing an increase from $38.51 million in the same quarter last year [2] - The current consensus EPS estimate for the coming quarter is -$0.43 on revenues of $52.94 million, and for the current fiscal year, it is -$2.27 on revenues of $174.83 million [7] Market Performance - Establishment Labs shares have increased approximately 88.5% since the beginning of the year, significantly outperforming the S&P 500's gain of 24.3% [3] - The company has surpassed consensus EPS estimates three times over the last four quarters, indicating a positive trend in earnings performance [2] Industry Outlook - The Medical Services industry, to which Establishment Labs belongs, is currently ranked in the bottom 45% of over 250 Zacks industries, suggesting potential challenges ahead [8] - The performance of Establishment Labs' stock may be influenced by the overall outlook for the industry, as research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8] Future Expectations - The sustainability of the stock's price movement will largely depend on management's commentary during the earnings call and the trends in earnings estimate revisions [3][4] - The estimate revisions trend for Establishment Labs is currently mixed, resulting in a Zacks Rank 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6]

Financial Performance - Third quarter worldwide revenue was $40.2 million, an increase from $38.5 million in the same period of 2023[2] - Updated 2024 revenue guidance is now $165 million to $168 million, down from previous guidance of $174 million to $184 million[2] - Third quarter loss from operations was $13.1 million, improved from a loss of $21.0 million in the year-ago period[2] - Adjusted EBITDA loss for the third quarter was $7.0 million, compared to a loss of $16.3 million in the same period last year[2] - Net loss for the third quarter was $16.7 million, an improvement from a net loss of $29.3 million in the year-ago period[3] - Net loss for the three months ended September 30, 2024, was $16,682,000, an improvement from a net loss of $29,273,000 in the same period last year[12] - Adjusted EBITDA for the three months ended September 30, 2024, was $(7,017,000), compared to $(16,278,000) in the prior year, reflecting a significant improvement[12] Cash and Assets - Cash balance as of September 30, 2024, was $39.7 million, with a pro forma cash balance of approximately $114.0 million after recent financing activities[2] - Total current assets increased to $182,953,000 as of September 30, 2024, up from $174,901,000 at December 31, 2023, representing a growth of 1.6%[11] - Accounts receivable rose significantly to $67,251,000, compared to $46,918,000 in the previous period, marking an increase of 43.3%[11] - Cash balance slightly decreased to $39,697,000 from $40,035,000, a reduction of 0.8%[11] Expenses and Liabilities - Total operating expenses decreased to $38.9 million from $47.1 million in the third quarter of 2023[3] - Total liabilities decreased slightly to $249,975,000 from $250,246,000, indicating a reduction of 0.1%[11] - Interest expense increased to $5,313,000 for the three months ended September 30, 2024, compared to $3,679,000 in the same period last year, an increase of 44.4%[12] Inventory and Equity - Inventory decreased to $67,122,000 from $79,471,000, showing a decline of 15.6%[11] - Total shareholders' equity increased to $32,710,000 from $18,395,000, representing a growth of 77.8%[11] Future Outlook - The company expects U.S. revenue to exceed $35 million in 2025 following the successful launch of Motiva Implants[2] - An agreement in principle was reached for R-Bridge Fund to invest up to $50 million in a Chinese distributor to support Motiva's growth in China[2] Currency Impact - Foreign currency gain for the three months ended September 30, 2024, was $2,204,000, compared to a loss of $(3,816,000) in the same period last year[12] Gross Profit - Gross profit for the third quarter was $25.7 million, representing a gross margin of 63.9%, down from 67.7% in the same period of 2023[3]

Group 1 - Establishment Labs Holdings Inc (ESTA) shares increased by 9.25% on October 2, reaching an intraday high of $44.42 before closing at $44.31, up from a previous close of $40.56 [1] - The current stock price is 26.30% below its 52-week high of $60.12 and 161.26% above its 52-week low of $16.96 [1] - Trading volume was 358,355 shares, which is 103.1% of the average daily volume of 347,701 [1] Group 2 - Wall Street analysts have set an average target price of $63.80 for Establishment Labs Holdings Inc, with a high estimate of $75.00 and a low estimate of $45.00, indicating a potential upside of 43.99% from the current price [2] - The average brokerage recommendation for Establishment Labs Holdings Inc is 1.8, suggesting an "Outperform" status on a scale where 1 is Strong Buy and 5 is Sell [2] - GuruFocus estimates the GF Value for Establishment Labs Holdings Inc at $82.42 in one year, indicating a potential upside of 86.01% from the current price [2]

Revenue Performance - Revenue for the six months ended June 30, 2024, was $81.3 million, a decrease of $13.8 million or 14.5% compared to $95.1 million in the same period of 2023[116] - Revenue decreased by $4.5 million, or 9.3%, to $44.1 million for the three months ended June 30, 2024, compared to $48.6 million for the same period in 2023[132] - The second half of fiscal year 2023 showed a slowdown in revenue growth due to macroeconomic conditions, with a 19% quarter-over-quarter increase in revenue observed in the latest quarter[127] - Sales of Motiva Implants accounted for over 99% of total revenues for the six months ended June 30, 2024[119] - The company expects revenue to increase as it enters new markets and launches Motiva Implants in the U.S., pending FDA approval[120] Net Losses and Financial Position - Net losses for the six months ended June 30, 2024, were $33.4 million, compared to $28.7 million for the same period in 2023, resulting in an accumulated deficit of $393.5 million[116] - The net loss for the six months ended June 30, 2024, was $33.4 million, influenced by changes in operating assets and liabilities[153] - Other income (expense), net decreased to a loss of $5.8 million for the six months ended June 30, 2024, compared to an income of $2.1 million for the same period in 2023[149] Operating Expenses and Cost Management - Total operating expenses decreased by $10.7 million, or 13.0%, to $71.5 million for the six months ended June 30, 2024[144] - Operating expenses decreased by $5.7 million, or 12.9%, to $38.3 million for the three months ended June 30, 2024, compared to $44.0 million for the same period in 2023[134] - SG&A expense decreased by $4.2 million, or 11.4%, to $32.8 million for the three months ended June 30, 2024[135] - R&D expense decreased by $1.4 million, or 20.3%, to $5.5 million for the three months ended June 30, 2024[137] - The company has implemented measures to align its cost base with current demand, including workforce downsizing and operational expenditure reductions[127] Manufacturing and Product Development - The FDA granted 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023, following the commercial launch of Motiva Implants in China in January 2024[115][117] - The company completed the construction of a new manufacturing facility in Costa Rica, increasing manufacturing capacity by approximately 730,000 units per year, with costs incurred of approximately $56.0 million[117] - The IDE clinical trial for Motiva Implants is expected to cost between $30.0 million and $40.0 million over ten years, with approximately $31.5 million spent to date[123] - The company is developing an enterprise resource planning system for the anticipated U.S. launch of Motiva Implants, incurring $4.8 million in costs for intangible assets[155] Interest and Financing Activities - Interest expense as of June 30, 2024, was $9.6 million, reflecting an increase from $7.4 million in the same period of 2023[129] - Interest expense increased to $9.6 million for the six months ended June 30, 2024, compared to $7.4 million for the same period in 2023[147] - Cash flows from financing activities provided $51.4 million in the first half of 2024, primarily from the issuance of common shares and pre-funded warrants, compared to $85.7 million in the same period of 2023[156] - As of June 30, 2024, the company had $196.4 million outstanding under the Credit Agreement, which includes $150 million for the Tranche A Term Loan and $25 million for the Tranche B Term Loan[158] Future Outlook and Capital Requirements - The company anticipates future capital requirements will depend on market adoption of its products, regulatory activities, and R&D costs[151] - The company filed a Shelf Registration Statement in April 2023, allowing it to raise additional capital through common shares and other securities until April 2026[151] - The company’s liquidity assumptions may prove incorrect, potentially requiring the use of available financial resources sooner than expected[151]

Financial Data and Key Metrics - Revenue for Q2 2024 totaled $44.1 million, an 18.7% sequential increase from Q1 2024 [4] - Year-over-year revenue declined by 9.3%, or 8.5% excluding foreign exchange impact [15] - Gross profit for Q2 2024 was $28.9 million, representing a gross margin of 65.6%, up from 62.3% in Q2 2023 [16] - Adjusted EBITDA loss was $4.3 million, similar to Q1 2024 but less than half of the $9.3 million loss in Q2 2023 [7][18] - Net loss from operations was $9.3 million, compared to $13.7 million in Q2 2023 [17] - Cash used in Q2 2024 was $18.4 million, with a cash position of $54.6 million as of June 30, 2024 [18][19] Business Line Performance - **Motiva Implants**: The company is nearing FDA approval, with manufacturing preparations underway for the US launch [7][29] - **Flora Tissue Expanders**: Gaining traction in the US, with VAC processes completed at several premier cancer centers [11] - **Mia Femtech**: Now available in 22 cities globally, with 63 certified plastic surgeons and 41 clinics in active negotiations [13][31] - **China**: On track to achieve $10 million in revenue for 2024, with ongoing medical education and marketing efforts [13][48] Regional Performance - **EMEA**: Contributed 48% of global revenue, with several markets fully recovered from last year's slowdown [6][16] - **Asia-Pacific**: Represented 32% of global revenue, showing improved demand as distributors reordered inventory [16][55] - **Latin America**: Contributed 20% of global revenue, with Brazil remaining weak and no significant recovery expected this year [6][16] - **North America**: Less than 1% of global revenue, but significant growth expected post-FDA approval [16][22] Strategic Direction and Industry Competition - The company is preparing for the US launch of Motiva Implants, which is expected to be a game-changer in the breast implant market [8][10] - The US market offers higher ASPs (3x to 4x higher than other markets), which will significantly boost profitability [22] - FDA approval is seen as a catalyst for global sales, as many surgeons outside the US rely on FDA clearance as a gold standard [22][36] - The company is focused on expanding its presence in China, aiming for market leadership in the coming years [13][49] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval soon, with no significant impact expected from the recent FDA inspection observations [5][25] - The company expects revenue growth to accelerate significantly in 2025, driven by the US launch and expansion in other markets [20][22] - Positive adjusted EBITDA and cash flow are expected soon after the US launch, with profitability targeted by fiscal year 2026 [21] Other Important Information - The company has two remaining tranches of $50 million in debt, accessible upon FDA approval and achieving $195 million in trailing 12-month sales [19] - Inventory days improved to more normalized levels, and days payable decreased in Q2 2024 [18] - Accounts receivable increased due to higher sales through distributors, but DSOs remained flat compared to Q1 2024 [18] Q&A Session Summary Question: Guidance and US Revenue Inclusion [24] - The company reiterated its 2024 revenue guidance of $174 million to $184 million, reflecting confidence in US approval and stable performance in other regions, despite weakness in Brazil [24] Question: FDA 483 Observations and Approval Timeline [25][26] - The FDA inspection resulted in three minor, non-systemic observations, which the company has already addressed, with no expected impact on the approval timeline [25][26] Question: US Launch Preparation and Sales Team [28][29] - The company has built an all-star team for the US launch, with back-office functions ready and initial batches of Motiva Implants already manufactured [29] Question: Mia Femtech Growth and Clinic Dynamics [30][31] - Mia Femtech is expanding rapidly, with 47% of Q2 patients being new to breast augmentation, indicating market expansion [31] Question: US Surgeon Awareness and Adoption [33][34] - Awareness of Motiva Implants among US plastic surgeons is growing, with strong interest driven by the product's safety profile and innovation [33][34] Question: International Adoption Post-FDA Approval [35][36] - FDA approval is expected to drive adoption in CE Mark countries, where many surgeons await FDA clearance before using new products [35][36] Question: Gross Margin Trajectory [38][39] - Gross margins improved in Q2 2024 due to higher ASPs, with further improvements expected as the US launch and other initiatives contribute to profitability [38][39] Question: Mia Licensing Fees and Revenue Growth [41][42] - Licensing fees for Mia Femtech are expected to grow as more clinics are onboarded, with significant revenue potential as clinics reach their case targets [41][42] Question: Accounts Receivable Increase [44][45] - The increase in accounts receivable was due to higher sales through distributors, particularly in Asia-Pacific, with no unusual factors [44][45] Question: China Market Growth [48][49] - The company remains on track for $10 million in revenue in China for 2024, with aspirations for market leadership in the coming years [48][49] Question: Q3 Seasonality and Distributor Reordering [52][53][54][55] - Q3 revenue is expected to decline by 10% sequentially, with a strong recovery anticipated in Q4, driven by US approval and distributor reordering [52][53][54][55] Question: Distributor Inventory Levels [55][56] - Distributors in Asia-Pacific are reordering at a healthy pace, indicating market recovery, while Latin America remains challenging due to political and economic factors [55][56]