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Establishment Labs Reports Third Quarter 2024 Financial Results

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Establishment Labs (NASDAQ: ESTA) reported Q3 2024 revenue of $40.2 million, compared to $38.5 million in Q3 2023. The company updated its 2024 revenue guidance to $165-168 million, down from previous $174-184 million. Q3 operating loss improved to $13.1 million from $21.0 million year-ago. The company strengthened its balance sheet with proforma cash of $114.0 million, including a $25.0 million credit facility and $50.0 million from stock sale. FDA approval of Motiva Implants was received on September 26, 2024, with expected U.S. revenue exceeding $35 million in 2025. The company has onboarded over 250 new accounts in the first three weeks of U.S. launch.

Establishment Labs (NASDAQ: ESTA) ha riportato un fatturato del terzo trimestre 2024 pari a $40.2 milioni, rispetto ai $38.5 milioni del terzo trimestre 2023. L'azienda ha aggiornato le sue proiezioni di fatturato per il 2024 a $165-168 milioni, in calo rispetto ai precedenti $174-184 milioni. La perdita operativa del terzo trimestre è migliorata a $13.1 milioni, rispetto ai $21.0 milioni dell'anno precedente. L'azienda ha rafforzato il suo bilancio con una liquidità proforma di $114.0 milioni, comprendente una linea di credito di $25.0 milioni e $50.0 milioni derivanti dalla vendita di azioni. L'approvazione della FDA per i Motiva Implants è stata ricevuta il 26 settembre 2024, con fatturato previsto negli Stati Uniti superiore ai $35 milioni nel 2025. L'azienda ha acquisito oltre 250 nuovi clienti nelle prime tre settimane del lancio negli Stati Uniti.

Establishment Labs (NASDAQ: ESTA) reportó ingresos de $40.2 millones en el tercer trimestre de 2024, en comparación con $38.5 millones en el tercer trimestre de 2023. La compañía actualizó su guía de ingresos para 2024 a entre $165 y $168 millones, bajando desde los anteriores $174 a $184 millones. La pérdida operativa del tercer trimestre mejoró a $13.1 millones desde $21.0 millones del año anterior. La compañía fortaleció su balance con un efectivo proforma de $114.0 millones, incluyendo una línea de crédito de $25.0 millones y $50.0 millones de la venta de acciones. La aprobación de la FDA para los Motiva Implants fue recibida el 26 de septiembre de 2024, con ingresos esperados en EE. UU. que superan los $35 millones en 2025. La compañía ha incorporado más de 250 nuevas cuentas en las primeras tres semanas del lanzamiento en EE. UU.

Establishment Labs (NASDAQ: ESTA)는 2024년 3분기 매출이 4020만 달러에 달했다고 보고했으며, 이는 2023년 3분기의 3850만 달러에 비해 증가한 수치입니다. 이 회사는 2024년 매출 전망을 1억 6500만에서 1억 6800만 달러로 업데이트했으며, 이는 이전의 1억 7400만에서 1억 8400만 달러에서 감소한 것입니다. 3분기 운영 손실은 1310만 달러로 개선되었으며, 이는 지난해의 2100만 달러에서 감소한 것입니다. 이 회사는 2천3백만 달러의 신용 시설과 5000만 달러의 주식 판매를 포함하여 프로포르마 현금으로 1억 1400만 달러의 재무 상태를 강화했습니다. 모티바 임플란트에 대한 FDA 승인은 2024년 9월 26일에 받았으며, 2025년에는 미국에서 3500만 달러 이상의 매출이 예상됩니다. 이 회사는 미국 출시의 첫 3주 동안 250개 이상의 신규 계정을 확보했습니다.

Establishment Labs (NASDAQ: ESTA) a rapporté un revenu de 40,2 millions de dollars pour le troisième trimestre de 2024, contre 38,5 millions de dollars au troisième trimestre de 2023. L'entreprise a mis à jour ses prévisions de revenus pour 2024 à 165-168 millions de dollars, en baisse par rapport aux précédents 174-184 millions de dollars. La perte d'exploitation du troisième trimestre s'est améliorée, s'élevant à 13,1 millions de dollars, contre 21,0 millions de dollars l'année précédente. L'entreprise a renforcé son bilan avec une trésorerie pro forma de 114,0 millions de dollars, y compris une ligne de crédit de 25,0 millions de dollars et 50,0 millions de dollars provenant de la vente d'actions. L'approbation de la FDA pour les implants Motiva a été reçue le 26 septembre 2024, avec des revenus américains attendus dépassant les 35 millions de dollars en 2025. L'entreprise a recruté plus de 250 nouveaux comptes au cours des trois premières semaines du lancement aux États-Unis.

Establishment Labs (NASDAQ: ESTA) meldete im dritten Quartal 2024 einen Umsatz von 40,2 Millionen Dollar, verglichen mit 38,5 Millionen Dollar im dritten Quartal 2023. Das Unternehmen aktualisierte seine Umsatzprognose für 2024 auf 165 bis 168 Millionen Dollar, nachdem die vorherige Prognose bei 174 bis 184 Millionen Dollar lag. Der Betriebsverlust im dritten Quartal verbesserte sich auf 13,1 Millionen Dollar von 21,0 Millionen Dollar im Vorjahr. Das Unternehmen hat seine Bilanz mit einem proforma Bargeldbestand von 114,0 Millionen Dollar gestärkt, einschließlich einer Kreditlinie von 25,0 Millionen Dollar und 50,0 Millionen Dollar aus dem Aktienverkauf. Die FDA-Zulassung für Motiva Implants wurde am 26. September 2024 erteilt, mit einem erwarteten Umsatz in den USA von über 35 Millionen Dollar im Jahr 2025. Das Unternehmen hat in den ersten drei Wochen des Launchs in den USA über 250 neue Konten gewonnen.

Positive
  • Operating loss improved by 37.6% YoY to $13.1 million
  • Adjusted EBITDA loss reduced by 57% to $7.0 million
  • Operating expenses decreased by $8.2 million to $38.9 million
  • FDA approval received for Motiva Implants
  • Rapid U.S. market penetration with 250+ new accounts in three weeks
Negative
  • Revenue guidance lowered from $174-184M to $165-168M
  • Gross profit margin declined from 67.7% to 63.9%
  • Net loss of $16.7 million in Q3
  • Continued weakness in Brazil market
  • $50 million stock offering priced at 5% discount

Insights

The Q3 results present a mixed picture for Establishment Labs. While revenue grew slightly to $40.2M from $38.5M YoY, the company reduced its 2024 guidance significantly to $165-168M from $174-184M. The silver lining is improved operational efficiency, with operating losses narrowing to $13.1M from $21.0M and adjusted EBITDA loss halving to $7.0M.

The recent FDA approval of Motiva Implants and strong initial U.S. launch traction (250+ new accounts in three weeks) provides significant growth potential, with projected U.S. revenue of $35M+ in 2025. The company has also strengthened its balance sheet through multiple financing initiatives, including a $50M direct offering and potential $50M investment from R-Bridge Fund for China expansion.

The FDA approval of Motiva Implants marks a pivotal milestone in the breast aesthetics market. The rapid adoption rate of 15 new accounts daily and deployment of 32 sales representatives (expanding to 40 by year-end) indicates strong market acceptance. The technology's safety profile and innovative features are driving surgeon preference, validating the company's global success pattern.

The strategic expansion in China through the R-Bridge Fund investment could significantly boost market penetration in the world's largest aesthetic surgery market. With nearly 4 million Motiva devices delivered globally and presence in 85+ countries, ESTA is positioned to challenge established players in the breast implant market.

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 third quarter ended September 30, 2024.

Third Quarter Highlights and Outlook

  • Third quarter worldwide revenue of $40.2 million.
  • 2024 revenue guidance updated to $165 million to $168 million from previous guidance of $174 million to $184 million.
  • Third quarter loss from operations was $13.1 million compared to a loss of $21.0 million in the year-ago period.
  • Adjusted EBITDA loss of $7.0 million compared to a loss of $16.3 million in the year-ago period.
  • Third quarter cash use was $14.9 million compared to use of $38.0 million in the year ago period.
  • Cash balance of $39.7 million as of September 30, 2024; approximately $114.0 million proforma cash balance including $25.0 million Tranche C of Oaktree credit facility drawn on October 8, 2024, and $50.0 million from sale of common stock on November 7, 2024.
  • $50 million registered direct offering priced at a 5% discount to the close of trading on November 7, 2024.
  • Oaktree credit facility amended to extend availability of $25 million Tranche D to December 31, 2025, subject to achieving revenue milestones.
  • Agreement in principle by R-Bridge Fund, an affiliate of CBC Group, to invest up to $50 million in Chinese distributor; proceeds to be used to support the growth of Motiva in China.
  • FDA approval of Motiva Implants on September 26, 2024.
  • Expected U.S. revenue to exceed $35 million in 2025.

“The U.S. launch of Motiva has exceeded even our high expectations,” said Juan José Chacón-Quirós, Chief Executive Officer. “The amazing response from plastic surgeons and women in the United States to Motiva has validated what we have seen in many other countries: namely that a safer implant that offers new options can move markets. We have onboarded over 250 new accounts in just the first three weeks of our launch and right now, we are adding 15 new accounts a day. We have 32 sales reps in the field and expect to be at 40 by year end.”

“We have taken this opportunity to strengthen our balance sheet and with the tangible results of reductions in our expense base, we are well funded for the opportunities ahead. We continue to focus on efficiencies across our global organization and our EBITDA loss was less than half of what it was a year ago despite increased investment in the United States,” Mr. Chacón-Quirós continued. “With the delay in U.S. FDA approval relative to our earlier expectations and continued weakness in Brazil, we are adjusting our guidance for 2024. We are on a clear path for global market leadership and have many years of significant double-digit revenue growth and emerging profitability ahead of us.”

Third Quarter 2024 Financial Results

Total revenue for the quarter ended September 30, 2024 was $40.2 million compared to $38.5 million for the same period in 2023.

Gross profit for the third quarter was $25.7 million, or 63.9% of revenue, compared to $26.1 million, or 67.7% of revenue, for the same period in 2023. The decrease in gross profit margin was primarily driven by geographic mix and changes in foreign currency exchange rates.

Total operating expenses for the third quarter were $38.9 million, a decrease of $8.2 million compared to $47.1 million in the third quarter of 2023.

SG&A expenses for the third quarter decreased approximately $5.9 million to $34.1 million compared to $40.0 million in the third quarter of 2023. The decrease in SG&A was primarily the result of the cost reduction initiatives, including headcount reductions, offset by increased investment in the United States.

R&D expenses decreased approximately $2.3 million to $4.8 million in the third quarter compared to $7.1 million for the same quarter a year ago. The decrease was primarily due to reductions in personnel costs.

Net loss for the third quarter was $16.7 million compared to a net loss of $29.3 million in the year ago period.

The Company’s cash balance on September 30, 2024 was $39.7 million. Cash decreased $0.3 million from December 31, 2023, primarily as a result of the private placement offering completed on January 9, partially offset by operating losses and investments in the new manufacturing facility. Pro forma cash balance approximately $114.0 million including $25.0 million Tranche C of Oaktree credit facility drawn on October 8, 2024, and $50.0 million from sale of common stock on November 7, 2024.

Conference Call and Webcast Information

Establishment Labs will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss its financial results. The conference call can be accessed by dialing (877) 407-8037 (U.S. and Canada) or (201) 689-8037 (international) and using conference ID number 13749629. In addition, the live and archived webcast will be available in the Investor Relations section of the Company's website at www.establishmentlabs.com.

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The nearly four million Motiva® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. Please visit our website for additional information at www.establishmentlabs.com.

Non-GAAP Financial Measures

To supplement our financial results presented in accordance with GAAP, this release includes the following measures defined by the Securities and Exchange Commission as non-GAAP financial measures: EBITDA and Adjusted EBITDA. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP, and may be different from non-GAAP measures used by other companies, limiting the usefulness of the measures for comparison with other companies.

EBITDA is defined as net income or loss excluding: (1) interest income and expense; (2) provision for income taxes; and (3) depreciation and amortization. We consider EBITDA useful to an investor in evaluating and facilitating comparisons of our operating performance between periods by removing the impact of our capital structure (primarily interest expense) and asset base (primarily depreciation and amortization) from our operating results.

We also present Adjusted EBITDA which includes additional adjustments for items such as other non-cash charges, gains or losses on extinguishment of debt, share-based compensation and foreign currency gains and losses. We believe that Adjusted EBITDA provides useful supplemental information to investors regarding our ongoing operating performance that, when considered with net income and EBITDA, is beneficial to an investor's understanding of our performance.

We believe disclosure of this information is also useful to investors as it provides insight into the earnings that management uses to make strategic decisions. These non-GAAP financial measures should be considered along with, but not as alternatives to, net income or loss as prescribed by GAAP as a measure of our operating performance. EBITDA and Adjusted EBITDA do not represent cash generated from operating activities under GAAP and should not be considered as alternatives to cash flows from operations or any other operating performance measure prescribed by GAAP. These measures are not measures of our liquidity, nor are indicative of funds available to fund our cash needs. These measurements do not reflect cash expenditures for long-term assets and other items that have been and will be incurred. EBITDA and Adjusted EBITDA may include funds that may not be available for management’s discretionary use due to functional requirements to conserve funds for capital expenditures, property acquisitions, and other commitments and uncertainties.

Please see “Reconciliation of EBITDA and Adjusted EBITDA” for a reconciliation of these measures to net income (loss), the most directly comparable financial measure. This release also includes information about our expectations regarding Adjusted EBITDA on a forward-looking basis. We have not provided a reconciliation of such forward-looking Adjusted EBITDA information because a reconciliation of such measure to our expected GAAP net income (loss) on a forward-looking basis is not available without unreasonable efforts. The timing or amount of various reconciling items that would impact the forward-looking expectations for this non-GAAP financial measure are uncertain, depend on various factors and cannot be reasonably predicted. Such unavailable information could be material to our results computed in accordance with U.S. GAAP.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “intends to,” “would,” “will,” “may” or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company’s annual report on Form 10-K filed on March 4, 2024 and will be discussed in the company's quarterly report on Form 10-Q that will be filed on November 12, 2024, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.

ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Revenue

 

$

40,227

 

 

$

38,506

 

 

$

121,511

 

 

$

133,591

 

Cost of revenue

 

 

14,510

 

 

 

12,454

 

 

 

42,478

 

 

 

47,199

 

Gross profit

 

 

25,717

 

 

 

26,052

 

 

 

79,033

 

 

 

86,392

 

Operating expenses:

 

 

 

 

 

 

 

 

Sales, general and administrative

 

 

34,055

 

 

 

39,962

 

 

 

95,788

 

 

 

108,695

 

Research and development

 

 

4,801

 

 

 

7,128

 

 

 

14,562

 

 

 

20,608

 

Total operating expenses

 

 

38,856

 

 

 

47,090

 

 

 

110,350

 

 

 

129,303

 

Loss from operations

 

 

(13,139

)

 

 

(21,038

)

 

 

(31,317

)

 

 

(42,911

)

Interest income

 

 

234

 

 

 

271

 

 

 

1,278

 

 

 

516

 

Interest expense

 

 

(5,313

)

 

 

(3,679

)

 

 

(14,880

)

 

 

(11,055

)

Other income (expense), net

 

 

2,046

 

 

 

(4,158

)

 

 

(3,770

)

 

 

(2,086

)

Loss before income taxes

 

 

(16,172

)

 

 

(28,604

)

 

 

(48,689

)

 

 

(55,536

)

Provision for income taxes

 

 

(510

)

 

 

(669

)

 

 

(1,376

)

 

 

(2,424

)

Net loss

 

$

(16,682

)

 

$

(29,273

)

 

$

(50,065

)

 

$

(57,960

)

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.59

)

 

$

(1.12

)

 

$

(1.80

)

 

$

(2.28

)

Weighted average outstanding shares used for basic and diluted net loss per share

 

 

28,248,256

 

 

 

26,034,185

 

 

 

27,885,255

 

 

 

25,444,155

 

 

 

 

 

 

 

 

 

 

ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Balance Sheets

(In thousands)

 

 

 

 

 

 

September 30,
2024

 

December 31,
2023

 

(Unaudited)

 

 

Assets

 

 

 

Current assets:

 

 

 

Cash

$

39,697

 

$

40,035

Accounts receivable, net of allowance for credit losses of $2,715 and $1,841

 

67,251

 

 

46,918

Inventory, net

 

67,122

 

 

79,471

Prepaid expenses and other current assets

 

8,883

 

 

8,477

Total current assets

 

182,953

 

 

174,901

Long-term assets:

 

 

 

Property and equipment, net of accumulated depreciation

 

79,423

 

 

77,205

Goodwill

 

465

 

 

465

Intangible assets, net of accumulated amortization

 

9,783

 

 

7,987

Right-of-use operating lease assets, net

 

4,849

 

 

3,381

Other non-current assets

 

5,212

 

 

4,702

Total assets

$

282,685

 

$

268,641

Liabilities and shareholders’ equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

34,397

 

$

41,624

Accrued liabilities

 

13,821

 

 

13,690

Other liabilities, short-term

 

2,280

 

 

1,836

Total current liabilities

 

50,498

 

 

57,150

Long-term liabilities:

 

 

 

Note payable, net of debt discount and issuance costs

 

194,360

 

 

188,739

Operating lease liabilities, non-current

 

3,825

 

 

2,712

Other liabilities, long-term

 

1,292

 

 

1,645

Total liabilities

 

249,975

 

 

250,246

Shareholders’ equity:

 

 

 

Total shareholders’ equity

 

32,710

 

 

18,395

Total liabilities and shareholders’ equity

$

282,685

 

$

268,641

 

 

 

 

ESTABLISHMENT LABS HOLDINGS INC.

Reconciliation of EBITDA and Adjusted EBITDA

(In thousands)

(Unaudited)

 

The following is a reconciliation of net loss to EBITDA and Adjusted EBITDA:

 

 

 

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Net loss

$

(16,682

)

 

$

(29,273

)

 

$

(50,065

)

 

$

(57,960

)

Interest expense

 

(5,313

)

 

 

(3,679

)

 

 

(14,880

)

 

 

(11,055

)

Interest income

 

234

 

 

 

271

 

 

 

1,278

 

 

 

516

 

Provision for income taxes

 

(510

)

 

 

(669

)

 

 

(1,376

)

 

 

(2,424

)

Depreciation and amortization

 

(1,990

)

 

 

(1,061

)

 

 

(4,680

)

 

 

(2,944

)

EBITDA

 

(9,103

)

 

 

(24,135

)

 

 

(30,407

)

 

 

(42,053

)

Stock compensation expense & compensation paid in stock

 

(4,290

)

 

 

(4,041

)

 

 

(11,712

)

 

 

(10,981

)

Foreign currency gain (loss)

 

2,204

 

 

 

(3,816

)

 

 

(3,579

)

 

 

(1,436

)

Adjusted EBITDA

$

(7,017

)

 

$

(16,278

)

 

$

(15,116

)

 

$

(29,636

)

 

 

 

 

 

 

 

 

 

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What was Establishment Labs (ESTA) revenue in Q3 2024?

Establishment Labs reported Q3 2024 revenue of $40.2 million, compared to $38.5 million in the same period of 2023.

When did ESTA receive FDA approval for Motiva Implants?

Establishment Labs received FDA approval for Motiva Implants on September 26, 2024.

What is ESTA's updated revenue guidance for 2024?

The company updated its 2024 revenue guidance to $165-168 million, reduced from the previous guidance of $174-184 million.

How many new accounts has ESTA added since the U.S. launch?

ESTA has onboarded over 250 new accounts in the first three weeks of its U.S. launch, adding approximately 15 new accounts per day.

Establishment Labs Holdings Inc.

NASDAQ:ESTA

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