UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38593 Establishment Labs Holdings Inc. (Exact name of Registrant as specified in its charter) British Virgin Islands 98 ...

Establishment Labs Holdings Inc. (ESTA) came out with a quarterly loss of $0.79 per share versus the Zacks Consensus Estimate of a loss of $0.95. This compares to loss of $0.55 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 16.84%. A quarter ago, it was expected that this company would post a loss of $0.72 per share when it actually produced a loss of $1.12, delivering a surprise of -55.56%.Over the last four quarters, the co ...

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 financial results for the fourth quarter and full year ended December 31, 2023 and provided 2024 guidance. Fourth Quarter Highlights and Outlook 2024 revenue guidance of $174 million to $184 million, an increase of 5% to 11% over 2023. Guidance does not include revenue from M ...

NEW YORK--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced that it has amended its $225 million term loan facility with funds managed by Oaktree Capital Management, L.P. (“Oaktree”). The terms on the two tranches already drawn under the facility, which total $175 million, are unchanged. The remaining two $25 million tranches are amended as follows: Tranche ...

The market expects Establishment Labs Holdings Inc. (ESTA) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended December 2023. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is ex ...

Revenue Performance - Revenue for the nine months ended September 30, 2023, was $133.6 million, an increase of $15.7 million or 13.3% compared to $117.9 million in the same period of 2022[199] - Revenue for the three months ended September 30, 2023, was $38.5 million, a slight increase from $38.2 million in the same period of 2022[227] - The Motiva breast implants accounted for over 96% of total revenues for the nine months ended September 30, 2023[211] - The first and second quarters of 2023 resulted in record quarterly revenue, driven by strong demand in the EMEA and Asia-Pacific regions[226] Net Losses and Financial Position - Net losses for the nine months ended September 30, 2023, were $58.0 million, a slight improvement from $61.6 million in the same period of 2022[199] - The net loss for the nine months ended September 30, 2023, was $58.0 million, with significant contributions from changes in operating assets and liabilities[256] - As of September 30, 2023, the accumulated deficit was $339.6 million, with a cash balance of $52.2 million[199] - As of September 30, 2023, the company had cash of $52.2 million, down from $66.4 million at the end of 2022[251] Operating Expenses - Total operating expenses increased by $10.5 million, or 28.7%, to $47.1 million for the three months ended September 30, 2023, compared to $36.6 million in 2022[232][233] - SG&A expenses rose by $8.7 million, or 27.8%, to $40.0 million for the three months ended September 30, 2023, primarily due to increased sales and marketing costs[233] - R&D expenses increased by $1.8 million, or 34.0%, to $7.1 million for the three months ended September 30, 2023, mainly due to higher personnel costs[234] - Total operating expenses for the nine months ended September 30, 2023, were $129.3 million, up from $104.9 million in 2022[243] Cash Flow and Financing Activities - The company reported a net cash used in operating activities of $80.4 million for the nine months ended September 30, 2023, compared to $38.2 million for the same period in 2022[256][257] - Net cash used in investing activities was $19.9 million for the nine months ended September 30, 2023, primarily for capital expenditures related to a new manufacturing facility, compared to $24.4 million in the same period of 2022[259][260] - The company generated $86.2 million in net cash from financing activities for the nine months ended September 30, 2023, mainly from the issuance of common shares, compared to $75.3 million in the same period of 2022[261][262] - The company issued 1,100,000 common shares at a public offering price of $71.50 per share, raising approximately $84.6 million in net proceeds[202] Manufacturing and Product Development - The FDA granted 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander in October 2023, and the company launched Zen, a next-generation passive RFID technology[200] - The company is expanding manufacturing facilities in Costa Rica, with an estimated $48 million in cash expenditures for the first phase, which will increase manufacturing capacity by approximately 730,000 units per year[208] - Cash paid for capital expenditures on construction in progress related to the new manufacturing facility was $12.3 million for the nine months ended September 30, 2023[259] Future Outlook - The company expects to continue incurring losses in the near term as it invests in sales growth and research and development[209] - The current global macroeconomic environment remains complex, with elevated inflation and interest rates impacting demand for products in the third quarter of 2023[226] - The company anticipates future capital requirements will depend on various factors, including market adoption of products and regulatory activities[254] Accounting Policies - The company has not made any material changes to its critical accounting policies as disclosed in its Annual Report on Form 10-K[267]

Establishment Labs Holdings Inc. (NASDAQ:ESTA) Q2 2023 Earnings Conference Call August 8, 2023 4:30 PM ET Company Participants Raj Denhoy - Chief Financial Officer Juan José Chacón-Quirós - Chief Executive Officer Conference Call Participants Young Li - Jefferies Anthony Petrone - Mizuho Group Josh Jennings - Cowen & Company Sam Eiber - BTIG Neil Chatterji - B. Riley George Sellers - Stephens Operator Good afternoon. Welcome to Establishment Labs’ Second Quarter 2023 Earnings Call. At this time, all partici ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38593 Establishment Labs Holdings Inc. (Exact name of Registrant as specified in its charter) British V ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38593 Establishment Labs Holdings Inc. (Exact name of Registrant as specified in its charter) British ...

Financial Data and Key Metrics Changes - Revenue in Q1 2023 totaled $46.5 million, representing a 21% increase compared to Q1 2022, marking a new quarterly record for the company [45][66] - Excluding the negative impact of foreign currency changes, revenue growth would have been approximately 22.9% [45][92] - Gross profit for Q1 was $30.1 million, or 64.7% of revenue, compared to $24.9 million, or 64.8% of revenue, in the same period of 2022 [66] - SG&A expenses increased to $31.7 million from $26.9 million in Q1 2022, partly due to investments in new growth initiatives [52][66] - Cash position as of March 31 was $42.8 million, down from $66.4 million at the end of 2022, with cash used including investments in a new manufacturing facility and inventory increases [53][94] Business Line Data and Key Metrics Changes - The launch of Mia Femtech in Japan is ongoing, with marketing efforts focused on creating demand through partner clinics [48][62] - Direct sales accounted for approximately 36% of global Motiva implant sales, with distributor sales making up the balance [92] - The company is actively preparing for the launch of Motiva in China, with expectations for the market to recover to pre-COVID levels by 2025 [50][12] Market Data and Key Metrics Changes - Motiva sales in Europe, the Middle East, and Africa represented approximately 44% of global sales, while Asia Pacific accounted for 31% and Latin America made up the remainder [66] - Brazil is the largest market globally, accounting for approximately 13% of total quarterly Motiva sales [66] Company Strategy and Development Direction - The company is focused on launching Mia as a new category in breast aesthetics, targeting consumers who are not interested in traditional breast augmentation [99] - Establishment Labs aims to expand geographically, with plans for Mia in Japan and Europe, and is preparing for the launch of Motiva in China [49][50][96] - The company is also investing in R&D and commercialization programs, with expectations for operating expenses as a percentage of revenue to trend down as new initiatives are leveraged [68][94] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the outlook for 2023, despite some uncertainty regarding the timing of initiatives in China and the US [17][37] - The company is preparing for significant growth opportunities, particularly with the launch of Mia and the expansion into new markets [96][88] - Management highlighted the importance of maintaining a strong cash position to fund growth initiatives [94] Other Important Information - The company completed a follow-on share offering that raised gross proceeds of $90.4 million, which was oversubscribed and brought in new investors [88] - The new manufacturing facility is expected to double the number of implants produced annually, addressing over half of the current world demand [97] Q&A Session Summary Question: How is the launch of Mia in Japan progressing? - Management is pleased with the launch and is focused on creating a new category in breast aesthetics rather than competing for market share in traditional breast augmentation [99] Question: What is the expected contribution of Flora to growth in 2023? - Flora is expected to contribute positively as more surgeons adopt it, particularly in sophisticated markets like Japan [104] Question: What is the investment required for the partnership model with clinics? - The partnership model requires both the company and clinics to invest in bringing new consumers into breast aesthetics [105] Question: What is the status of the regulatory process for Motiva in China? - The company is in the final phase of preparation for the launch in China, pending approval from the NMPA [110] Question: How will SG&A expenses trend for the rest of the year? - SG&A expenses are expected to remain similar to 2022 as the company continues to invest in growth initiatives [111]