EDAP Reports Record HIFU Fourth Quarter and Full-Year 2024 Results
EDAP TMS reported record financial results for Q4 and full-year 2024, with notable growth in its HIFU business segment. The company achieved record full-year HIFU revenue of USD 25.7 million, up 15.3% from 2023, and Q4 HIFU revenue of USD 9.3 million, a 15% increase year-over-year.
Key highlights include a 51% growth in U.S. Focal One HIFU procedures in 2024, CE Mark approval for deep infiltrating endometriosis treatment, and positive outcomes from the HIFI study comparing Focal One® Robotic HIFU versus surgery in prostate cancer management. The company also initiated a Phase I/II study for Benign Prostatic Hyperplasia (BPH) treatment.
Financial results show total Q4 2024 revenue of USD 21.5 million, up 3.6% year-over-year, with a gross profit margin of 44.8%. The company reported a Q4 net loss of USD 2.1 million and held cash reserves of USD 30.9 million as of December 31, 2024.
EDAP TMS ha riportato risultati finanziari record per il quarto trimestre e l'intero anno 2024, con una crescita notevole nel suo segmento di business HIFU. L'azienda ha raggiunto un fatturato HIFU annuale record di 25,7 milioni di USD, in aumento del 15,3% rispetto al 2023, e un fatturato HIFU per il quarto trimestre di 9,3 milioni di USD, con un incremento del 15% rispetto all'anno precedente.
I punti salienti includono una crescita del 51% nelle procedure HIFU Focal One negli Stati Uniti nel 2024, l'approvazione del marchio CE per il trattamento dell'endometriosi profonda e risultati positivi dallo studio HIFI che confronta HIFU Robotic Focal One® rispetto alla chirurgia nella gestione del cancro alla prostata. L'azienda ha anche avviato uno studio di fase I/II per il trattamento dell'iperplasia prostatica benigna (BPH).
I risultati finanziari mostrano un fatturato totale per il quarto trimestre 2024 di 21,5 milioni di USD, in aumento del 3,6% rispetto all'anno precedente, con un margine di profitto lordo del 44,8%. L'azienda ha riportato una perdita netta di 2,1 milioni di USD nel quarto trimestre e dispone di riserve di cassa di 30,9 milioni di USD al 31 dicembre 2024.
EDAP TMS reportó resultados financieros récord para el cuarto trimestre y el año completo 2024, con un notable crecimiento en su segmento de negocio HIFU. La compañía logró un ingreso HIFU anual récord de 25,7 millones de USD, un aumento del 15,3% respecto a 2023, y un ingreso HIFU del cuarto trimestre de 9,3 millones de USD, un incremento del 15% interanual.
Los aspectos más destacados incluyen un crecimiento del 51% en los procedimientos HIFU Focal One en EE. UU. en 2024, la aprobación de la marca CE para el tratamiento de la endometriosis profunda y resultados positivos del estudio HIFI que compara HIFU Robótico Focal One® con cirugía en el manejo del cáncer de próstata. La empresa también inició un estudio de fase I/II para el tratamiento de la hiperplasia prostática benigna (BPH).
Los resultados financieros muestran un ingreso total para el cuarto trimestre de 2024 de 21,5 millones de USD, un aumento del 3,6% interanual, con un margen de ganancia bruta del 44,8%. La compañía reportó una pérdida neta de 2,1 millones de USD en el cuarto trimestre y tenía reservas de efectivo de 30,9 millones de USD al 31 de diciembre de 2024.
EDAP TMS는 2024년 4분기 및 연간 재무 실적이 기록적이라고 보고했으며, HIFU 사업 부문에서 주목할 만한 성장을 보였습니다. 이 회사는 연간 HIFU 수익이 2570만 달러에 달했으며, 이는 2023년 대비 15.3% 증가한 수치입니다. 4분기 HIFU 수익은 930만 달러로, 전년 대비 15% 증가했습니다.
주요 하이라이트로는 2024년 미국에서 Focal One HIFU 절차가 51% 증가했으며, 깊은 침윤성 자궁내막증 치료를 위한 CE 마크 승인을 받았고, 전립선암 관리에서 Focal One® 로봇 HIFU와 수술을 비교한 HIFI 연구에서 긍정적인 결과가 나왔습니다. 또한 이 회사는 양성 전립선 비대증(BPH) 치료를 위한 1/2단계 연구를 시작했습니다.
재무 결과에 따르면 2024년 4분기 총 수익은 2150만 달러로, 전년 대비 3.6% 증가했으며, 총 이익률은 44.8%입니다. 이 회사는 4분기 순손실이 210만 달러였으며, 2024년 12월 31일 기준으로 현금 보유액이 3090만 달러에 달했습니다.
EDAP TMS a annoncé des résultats financiers records pour le quatrième trimestre et l'année entière 2024, avec une croissance notable dans son segment d'activité HIFU. L'entreprise a atteint un chiffre d'affaires HIFU annuel record de 25,7 millions USD, en hausse de 15,3 % par rapport à 2023, et un chiffre d'affaires HIFU pour le quatrième trimestre de 9,3 millions USD, soit une augmentation de 15 % d'une année sur l'autre.
Les points forts incluent une croissance de 51 % des procédures HIFU Focal One aux États-Unis en 2024, l'approbation du marquage CE pour le traitement de l'endométriose profonde, et des résultats positifs de l'étude HIFI comparant le HIFU robotique Focal One® à la chirurgie dans la gestion du cancer de la prostate. L'entreprise a également lancé une étude de phase I/II pour le traitement de l'hyperplasie bénigne de la prostate (HBP).
Les résultats financiers montrent un chiffre d'affaires total pour le quatrième trimestre 2024 de 21,5 millions USD, en hausse de 3,6 % d'une année sur l'autre, avec une marge brute de 44,8 %. L'entreprise a signalé une perte nette de 2,1 millions USD au quatrième trimestre et disposait de réserves de liquidités de 30,9 millions USD au 31 décembre 2024.
EDAP TMS hat für das vierte Quartal und das gesamte Jahr 2024 Rekordergebnisse im Finanzbereich gemeldet, mit bemerkenswertem Wachstum im HIFU-Geschäftssegment. Das Unternehmen erzielte einen Rekordumsatz von 25,7 Millionen USD im HIFU-Bereich für das gesamte Jahr, was einem Anstieg von 15,3 % im Vergleich zu 2023 entspricht, und einen HIFU-Umsatz von 9,3 Millionen USD im vierten Quartal, was einem Anstieg von 15 % im Jahresvergleich entspricht.
Zu den wichtigsten Highlights gehören ein Wachstum von 51 % bei den HIFU-Verfahren Focal One in den USA im Jahr 2024, die CE-Zulassung für die Behandlung von tief infiltrierender Endometriose und positive Ergebnisse aus der HIFI-Studie, die Focal One® Robotic HIFU mit einer Operation bei der Behandlung von Prostatakrebs vergleicht. Das Unternehmen hat auch eine Phase I/II-Studie zur Behandlung der benignen Prostatahyperplasie (BPH) gestartet.
Die finanziellen Ergebnisse zeigen einen Gesamtumsatz von 21,5 Millionen USD im vierten Quartal 2024, was einem Anstieg von 3,6 % im Jahresvergleich entspricht, mit einer Bruttomarge von 44,8 %. Das Unternehmen berichtete von einem Nettoverlust von 2,1 Millionen USD im vierten Quartal und verfügte zum 31. Dezember 2024 über Barreserven in Höhe von 30,9 Millionen USD.
- Record HIFU revenue growth: 15.3% increase to USD 25.7 million for full-year 2024
- 51% growth in U.S. Focal One HIFU procedures year-over-year
- Improved gross profit margin to 44.8% in Q4 2024 from 43.7% in Q4 2023
- CE Mark approval for endometriosis treatment expanding market opportunities
- Medicare payment rate increase of 5.4% for HIFU procedures in 2025
- Q4 2024 net loss of USD 2.1 million
- Full-year operating loss increased to USD 22.2 million from USD 21.5 million in 2023
- Cash position decreased to USD 30.9 million from USD 48.1 million year-over-year
- Distribution business revenue declined in Q4 2024 compared to Q4 2023
Insights
EDAP's Q4 and full-year 2024 results present a nuanced financial picture with clear momentum in their core HIFU business. The 15.3% growth in annual HIFU revenue to
The 28.5% growth in disposables revenue is particularly significant as it indicates increasing utilization of already-installed systems—a crucial recurring revenue stream with higher margins. The 51% year-over-year growth in US procedures further confirms the technology's adoption trajectory in the critical US market.
Despite these positive indicators, EDAP still operates at a loss with operating expenses of
The CMS reimbursement approval with a 5.4% increase to
EDAP appears to be at an inflection point: still unprofitable but demonstrating the commercial traction and clinical validation needed to support continued growth. The strategic focus on reducing investment in non-core products while expanding HIFU applications suggests disciplined capital allocation toward their highest-potential business segment.
The publication of the HIFI study in European Urology represents a landmark clinical validation for EDAP's focal therapy approach. This seven-year study involving 3,328 patients across 46 treatment centers provides robust comparative evidence supporting HIFU versus radical prostatectomy—potentially reshaping the prostate cancer treatment paradigm.
The CE Mark certification for treating deep infiltrating endometriosis significantly expands the Focal One platform's addressable market beyond prostate applications. Endometriosis affects approximately 10% of reproductive-age women globally, with deep infiltrating endometriosis representing some of the most challenging cases with treatment options.
EDAP's clinical pipeline development shows strategic diversification of the HIFU platform across multiple conditions. The initiation of the Phase I/II BPH trial targets a massive market—BPH affects over 50% of men by age 60—with current treatments often involving medication with side effects or invasive surgical procedures.
The pancreatic cancer PULS Trial represents a high-risk, high-reward opportunity in a devastating disease with poor treatment options. The demonstration of histotripsy capabilities (non-thermal tissue destruction) with the Focal One technology also suggests potential technical versatility beyond traditional HIFU thermal ablation.
The integration with OnQ Prostate's Restriction Spectrum Imaging technology for improved lesion targeting demonstrates EDAP's focus on enhancing the precision and efficacy of their platform. With 11 Focal One systems sold in Q4 alone, the technology appears to be gaining clinical acceptance at an accelerating rate.
- Record full-year 2024 HIFU revenue of USD 25.7 million, an increase of
15.3% over full-year 2023 - Record Q4 2024 HIFU revenue of USD 9.3 million, an increase of
15.0% over Q4 2023 - U.S. Focal One HIFU procedures grew
51% on a year-over-year basis in 2024 - Focal One receives CE Mark for the treatment of deep infiltrating endometriosis
- Recent landmark HIFI study publication demonstrates positive outcomes with Focal One® Robotic HIFU versus surgery in the management of prostate cancer
- First patients treated in Phase I/II study evaluating Focal One Robotic HIFU for the treatment of Benign Prostatic Hyperplasia (BPH)
- Company to host conference call and webcast today, March 27th, at 8:30 a.m. EDT
AUSTIN, Texas, March 27, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the fourth quarter and full-year 2024.
“Our strong fourth quarter performance reflects our continued progress in establishing Focal One Robotic HIFU as a mainstream treatment option for the management of prostate cancer,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “We achieved a quarterly record number of sales for Focal One systems, both in the U.S. and globally, and the number of Focal One procedures continues to grow at a solid pace. In December, we announced the publication of the HIFI Study in the prestigious medical journal, European Urology. We believe the positive results from this landmark clinical trial have the ability to reshape the treatment paradigm for prostate cancer and ultimately help drive further adoption of the Focal One platform.
“As we build momentum in our core Focal One business, we remain focused on expanding into multiple high growth opportunities for therapeutic HIFU, while also reducing investments in non-core products. Given Focal One’s market leading technology, I believe we are uniquely positioned to create significant value for patients, physicians and our shareholders as we continue expanding into the prostate cancer market, while also advancing our clinical development programs in endometriosis, benign prostatic hyperplasia (BPH), and pancreatic cancer.”
Business Update
- On March 26, 2025, the Company’s Focal One Robotic HIFU System received CE Mark certification from GMED, EDAP’s notified body, for the treatment of posterior deep endometriosis infiltrating the rectum and surrounding structures.
- The Company recently attended the European Association of Urology Meeting, which took place in Madrid, Spain from March 21-24, 2025. During the conference, the Company offered numerous hands-on simulations with Focal One while also discussing the treatment implications from the recently published landmark HIFI Study.
- On March 3, 2025, the Company announced the appointment of Glen French to its Board of Directors. Mr. French is a highly accomplished executive with extensive business and clinical expertise in the development of innovative new medical devices and technology. For nearly a decade, Glen was the President and CEO of Pulmonx Corporation, which develops minimally invasive technologies for the diagnosis and treatment for patients with severe emphysema. Under his leadership, Pulmonx experienced more than
20% annual compound revenue growth rate. Over the course of his career, he has co-founded, built and sold three medical device companies and took a fourth company public. - On February 6, 2025, the Company announced the successful completion of the world’s first OnQ Prostate-assisted Focal One Robotic HIFU procedure at the University of California, San Francisco (UCSF) Prostate Center. This milestone marks the first clinical application of OnQ Prostate’s patented Restriction Spectrum Imaging (RSI) technology to guide focal therapy, demonstrating how advanced MR-imaging can improve lesion localization and targeting for urologists performing focal therapy.
- On January 10, 2025, the Company announced the appointment of Joshua H. Levine to its Board of Directors. Mr. Levine is a strategic business leader with decades of diverse global board and executive management experience within the medical technology industry. He possesses a deep expertise in portfolio transformation, strategic business development and driving shareholder value. From 2012 to 2022, Mr. Levine served as President, Chief Executive Officer, and Director of Accuray Incorporated, where he led a transformative turnaround that involved all strategic, operational, and financial activities that restored the business to consistent top line growth, positive operating profit, free cash flow (EBITDA), and expanded the company’s global footprint.
- On December 4, 2024, the Company announced the publication of the full results from the HIFI study in the prestigious, peer-reviewed journal, European Urology, which has the highest impact factor amongst scientific journals focused in urology. The study evaluated HIFU versus radical prostatectomy (RP) as a first line treatment of localized prostate cancer. The paper is entitled “Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized, HIFI Trial” and is authored by Dr. Guillaume Ploussard from Department of Urology, UROSUD, Clinique La Croix du Sud, France. A link to the publication can be found here.
HIFI is the first prospective, multi-center, non-inferiority comparative study evaluating HIFU and RP in the management of localized prostate cancer. This seven-year study (April 2015 - March 2022) enrolled a total of 3,328 patients from 46 treatment centers: 1,967 consecutive patients were treated with EDAP’s robotic HIFU technologies, where Focal One was used for
- On November 22, 2024, the Company announced a scientific presentation which demonstrated the technical feasibility of performing non-thermal histotripsy energy delivery and generating histotripsy lesions in biological tissues ex vivo using the Company’s Focal One Robotic HIFU technology. The results from the study were presented on November 19th at the 187th Acoustical Society of America meeting, which is took place virtually from November 18 - 22, 2024.
- On November 2, 2024, the Center for Medicare and Medicaid Services, CMS, released the final payment rules for 2025. The HIFU procedure continues to be supported with favorable reimbursement with CMS finalizing a Medicare Hospital payment rate of
$9,247 as a national average, adjusted locally with the corresponding local wage index factor. The rate will become effective on January 1, 2025, and represents a5.4% increase over the 2024 payment. This continues to support the favorable strategic business case for hospitals to both invest and integrate Focal One HIFU while providing greater access to this valuable, non-invasive treatment option.
CMS also released the physician fee schedule for 2025 which continues to provide strong physician reimbursement for HIFU with 17.73 work relative value units, or work RVUs, and 29.41 Total RVUs. These figures are significantly higher than any other prostate ablation procedure. Additionally, it provides physicians with a level of reimbursement that is more than
Clinical Pipeline Update
Pancreatic Cancer Program
- On January 8, 2025, the Company announced that the first patient was treated in the phase I/II PULS Trial sponsored by the Centre Léon Bérard, Lyon, France, evaluating proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of pancreatic tumors. The PULS Trial is a phase I/II, multicenter study for patients with locally advanced and unresectable pancreatic tumors. The phase I trial aims at evaluating the tolerance of intraoperative HIFU intervention on the pancreatic lesion. The phase II trial aims at evaluating the preliminary efficacy of the HIFU intervention.
Benign Prostate Hyperplasia (BPH) Program
- On October 1, 2024, the Company announced that the first patients were treated in Phase I/II study evaluating Focal One Robotic HIFU for the treatment of benign prostatic hyperplasia (BPH). The Phase I/II study is a company-sponsored, prospective, multicenter clinical trial designed as a two-part study. Part 1 of the Phase I/II study will take place at three leading academic prostate treatment centers in France with a recognized expertise in the treatment of BPH as well as in the use of Focal One HIFU technology. Part 1 is designed to define the optimal treatment parameters to effectively treat BPH and its related symptoms with minimal side effects. Part 2 of the study will expand patient enrollment across a larger number of treatment centers in order to validate the safety and efficacy of the parameters as defined in Part 1 of the study. In July, the Company received approval from the French National Agency for Medicines and Health Products Safety (ANSM) to initiate a Phase I/II clinical trial investigating Focal One Robotic HIFU in BPH.
Upcoming Meetings and Events
In the second quarter of 2025, EDAP expects to have its largest presence at this year’s the American Urology Association (AUA) Meeting, which will place from April 26-29, 2025, in Las Vegas, Nevada. The AUA meeting is the most widely attended urology-focused conference in the world and is considered the most highly influential, global medical meeting focused on urology.
Fourth Quarter 2024 Results
Total worldwide revenue for the fourth quarter of 2024 was EUR 20.3 million (USD 21.5 million), an increase of
Total revenue in the HIFU business for the fourth quarter of 2024 was EUR 8.8 million (USD 9.3 million), as compared to EUR 7.5 million (USD 8.1 million) for the fourth quarter of 2023. The Company sold 11 Focal One systems during the fourth quarter of 2024 versus 10 systems sold in the fourth quarter of 2023. Worldwide disposables revenue grew
Total revenue in the Distribution business for the fourth quarter of 2024 was EUR 9.1 million (USD 9.6 million), as compared to EUR 9.9 million (USD 10.7 million) for the fourth quarter of 2023. The decrease in Distribution revenue was driven primarily by product mix.
Total revenue in the LITHO business for the fourth quarter of 2024 was EUR 2.4 million (USD 2.6 million), as compared to EUR 2.3 million (USD 2.5 million) for the fourth quarter of 2023. The increase in LITHO revenue was driven by 5 lithotripsy units sold in the fourth quarter of 2024 as compared to 3 units sold in the fourth quarter of 2023.
Gross profit for the fourth quarter of 2024 was EUR 9.1 million (USD 9.6 million), compared to EUR 8.6 million (USD 9.3 million) for the same period in 2023. Gross profit margin on net sales was
Operating expenses were 12.8 million euros (USD 13.6 million) for the fourth quarter, compared to 12.0 million euros (USD 13.1 million) for the same period in 2023. The modest increase in operating expenses was primarily due to focused investments in our HIFU business segment, as well as variable compensation.
Operating loss for the fourth quarter of 2024 was EUR 3.7 million (USD 4.0 million), compared to an operating loss of EUR 3.5 million (USD 3.8 million) in the fourth quarter of 2023.
Net loss for the fourth quarter of 2024 was EUR 1.9 million (USD 2.1 million), or EUR (0.05) per share, as compared to net loss of EUR 5.0 million (USD 5.5 million), or EUR (0.14) per share in the fourth quarter of 2023.
Full-Year 2024 Results
Total worldwide revenue for the twelve months ended December 31, 2024, was EUR 64.1 million (USD 69.2 million), an increase of
Total revenue in the HIFU business for the twelve months ended December 31, 2024, was EUR 23.8 million (USD 25.7 million), an increase of
Total revenue in the Distribution business for the twelve months ended December 31, 2024, was EUR 31.3 million (USD 33.8 million), an increase of
Total revenue in the LITHO business for the twelve months ended December 31, 2024, was EUR 9.0 million (USD 9.7 million), a decrease of
Gross profit for the twelve months ended December 31, 2024, was EUR 26.6 million (USD 28.7 million), compared to EUR 24.4 million (USD 26.4 million), for the twelve months ended December 31, 2023. Gross profit margin on net sales was
Operating expenses were EUR 47.1 million (USD 50.8 million) for the twelve months ended December 31, 2024, compared to EUR 44.2 million (USD 47.9 million) for the same period in 2023.
Operating loss for the twelve months ended December 31, 2024, was EUR 20.5 million (USD 22.2 million), compared to an operating loss of EUR 19.8 million (USD 21.5 million) for the twelve months ended December 31, 2023.
Net loss for the twelve months ended December 31, 2024, was EUR 19.0 million (USD 20.5 million), or EUR (0.51) per share, as compared to a net loss of EUR 21.2 million (USD 22.9 million), or EUR (0.57) per share for the twelve months ended December 31, 2023.
As of December 31, 2024, the Company held cash and cash equivalents of EUR 29.8 million (USD 30.9 million) as compared to EUR 43.5 million (USD 48.1 million) as of December 31, 2023.
Conference Call Information
A conference call and webcast to discuss the fourth quarter and full year 2024 financial results will be hosted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting Officer. Please refer to the information below for conference call dial-in information and webcast registration.
Date: Thursday, March 27th @ 8:30am Eastern Time
Domestic: 1-800-225-9448
International: 1-203-518-9708
Passcode (Conf ID): EDAP
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1706804&tp_key=5b71915afc
About EDAP TMS SA
A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP TMS introduced the Focal One® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.
Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.
Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.
Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com
Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
| | | | | | | | | |
| | | Three Months Ended: | | Three Months Ended: | ||||
| | December 31, | December 31, | December 31, | December 31, | ||||
| | | 2024 | | 2023 | | 2024 | | 2023 |
| | | Euros | | Euros | | $US | | $US |
| Sales of goods | 14,559 | 15,021 | 15,410 | 16,292 | ||||
| Net sales of RPP and leases | 2,363 | 1,611 | 2,501 | 1,747 | ||||
| Sales of spare parts, supplies and services | 3,395 | 2,981 | 3,594 | 3,233 | ||||
| TOTAL REVENUES | 20,318 | 19,613 | 21,505 | 21,272 | ||||
| Cost of sales | (11,220) | (11,051) | (11,875) | (11,986) | ||||
| GROSS PROFIT | 9,098 | 8,562 | 9,629 | 9,286 | ||||
| Research & development expenses | (1,865) | (2,201) | (1,974) | (2,387) | ||||
| Selling, general & administrative expenses | (10,971) | (9,842) | (11,612) | (10,674) | ||||
| Total operating expenses | (12,836) | (12,042) | (13,586) | (13,061) | ||||
| OPERATING LOSS | (3,738) | (3,481) | (3,957) | (3,775) | ||||
| Interest (expense) income, net | 122 | 220 | 130 | 239 | ||||
| Currency exchange gains (loss), net | 1,664 | (1,450) | 1,761 | (1,573) | ||||
| LOSS BEFORE INCOME TAXES | (1,952) | (4,710) | (2,066) | (5,109) | ||||
| Income tax (expense) credit, net | 11 | (332) | 12 | (361) | ||||
| NET LOSS | (1,940) | (5,043) | (2,054) | (5,469) | ||||
| Loss per share – Basic and diluted | (0.05) | (0.14) | (0.05) | (0.15) | ||||
| Average number of shares used in computation of basic and diluted EPS | 37,371,992 | 37,066,627 | 37,371,992 | 37,066,627 | ||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2024 average three months’ exchange rate of 1 Euro = 1.0584 USD, and 2023 average three months’ exchange rate of 1 Euro = 1.0846 USD
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
| | | | | | | | | |
| | | Year Ended: | | Year Ended: | ||||
| | December 31, | December 31, | December 31, | December 31, | ||||
| | | 2024 | | 2023 | | 2024 | | 2023 |
| | | Euros | | Euros | | $US | | $US |
| Sales of goods | 44,037 | 42,333 | 47,515 | 45,835 | ||||
| Net sales of RPP and leases | 7,610 | 6,176 | 8,211 | 6,687 | ||||
| Sales of spare parts, supplies and services | 12,468 | 11,914 | 13,452 | 12,899 | ||||
| TOTAL REVENUES | 64,114 | 60,423 | 69,178 | 65,421 | ||||
| Cost of sales | (37,558) | (36,012) | (40,524) | (38,991) | ||||
| GROSS PROFIT | 26,556 | 24,411 | 28,654 | 26,430 | ||||
| Research & development expenses | (7,726) | (6,963) | (8,337) | (7,539) | ||||
| Selling, general & administrative expenses | (39,364) | (37,261) | (42,473) | (40,343) | ||||
| Total operating expenses | (47,090) | (44,224) | (50,809) | (47,882) | ||||
| OPERATING LOSS | (20,534) | (19,813) | (22,156) | (21,452) | ||||
| Interest (expense) income, net | 560 | 1,079 | 604 | 1,168 | ||||
| Currency exchange gains (loss), net | 1,245 | (1,799) | 1,344 | (1,948) | ||||
| LOSS BEFORE INCOME TAXES | (18,729) | (20,533) | (20,208) | (22,232) | ||||
| Income tax (expense) credit, net | (289) | (644) | (312) | (698) | ||||
| NET LOSS | (19,018) | (21,178) | (20,520) | (22,930) | ||||
| Loss per share – Basic and diluted | (0.51) | (0.57) | (0.55) | (0.62) | ||||
| Average number of shares used in computation of basic and diluted EPS | 37,286,446 | 36,996,722 | 37,286,446 | 36,996,722 | ||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2024 average twelve months’ exchange rate of 1 Euro = 1.0790 USD, and 2023 average twelve months’ exchange rate of 1 Euro = 1.0827 USD
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of Euros and U.S. Dollars)
| | | | | | | | | |
| | December 31, | December 31, | December 31, | December 31, | ||||
| | | 2024 | | 2023 | | 2024 | | 2023 |
| | | Euros | | Euros | | $US | | $US |
| Cash, cash equivalents and short-term investments | 29,836 | 43,471 | 30,883 | 48,087 | ||||
| Accounts receivable, net | 20,288 | 19,238 | 21,000 | 21,281 | ||||
| Inventory | 18,495 | 15,112 | 19,143 | 16,717 | ||||
| Other current assets | 1,258 | 659 | 1,302 | 729 | ||||
| TOTAL CURRENT ASSETS | 69,876 | 78,480 | 72,328 | 86,814 | ||||
| Property, plant and equipment, net | 10,336 | 8,193 | 10,699 | 9,063 | ||||
| Goodwill | 2,412 | 2,412 | 2,496 | 2,668 | ||||
| Other non-current assets | 3,439 | 2,464 | 3,560 | 2,725 | ||||
| TOTAL ASSETS | 86,063 | 91,548 | 89,083 | 101,270 | ||||
| Accounts payable & other accrued liabilities | 21,350 | 18,435 | 22,099 | 20,392 | ||||
| Deferred revenues, current portion | 6,641 | 4,049 | 6,874 | 4,479 | ||||
| Short term borrowing | 6,243 | 2,466 | 6,462 | 2,728 | ||||
| Other current liabilities | 3,577 | 2,646 | 3,702 | 2,927 | ||||
| TOTAL CURRENT LIABILITIES | 37,811 | 27,596 | 39,138 | 30,526 | ||||
| Obligations under operating and finance leases non-current | 1,939 | 1,315 | 2,007 | 1,454 | ||||
| Long-term debt, non-current | 2,162 | 1,997 | 2,238 | 2,209 | ||||
| Deferred revenues, non-current | 358 | 643 | 370 | 712 | ||||
| Other long-term liabilities | 2,897 | 3,075 | 2,999 | 3,402 | ||||
| TOTAL LIABILITIES | 45,167 | 34,626 | 46,752 | 38,304 | ||||
| TOTAL SHAREHOLDERS’EQUITY | 40,896 | 56,922 | 42,331 | 62,966 | ||||
| TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY | 86,063 | 91,548 | 89,083 | 101,270 |
NOTE: Translated for convenience of the reader to U.S. dollars at the exchange rate of 1 Euro = 1.0351 USD, on December 31, 2024 and at the exchange rate of 1 Euro = 1.1062 USD, on December 31, 2023.
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of Euros and U.S. Dollars)
| | | | | | | | | |
| | Year Ended | Twelve Months Ended | Year Ended | Twelve Months Ended | ||||
| | | December 31, | | December 31, | | December 31, | | December 31, |
| | | 2024 | | 2023 | | 2024 | | 2023 |
| | | (Euros) | | (Euros) | | ($US) | | ($US) |
| NET INCOME (LOSS) | (19,018) | (21,178) | (20,520) | (22,930) | ||||
| Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1) | 7,395 | 9,403 | 7,979 | 10,181 | ||||
| OPERATING CASH FLOW | (11,623) | (11,775) | (12,541) | (12,749) | ||||
| Increase/Decrease in operating assets and liabilities | (1,961) | (2,903) | (2,116) | (3,144) | ||||
| NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES | (13,584) | (14,678) | (14,657) | (15,892) | ||||
| Additions to capitalized assets produced by the company and other capital expenditures | (4,120) | (4,344) | (4,445) | (4,704) | ||||
| NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES | (4,120) | (4,344) | (4,445) | (4,704) | ||||
| NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES | 4,635 | (911) | 5,001 | (986) | ||||
| NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (566) | 268 | (3,103) | 2,130 | ||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (13,635) | (19,666) | (17,204) | (19,452) |
(1) including share based compensation expenses for 3,283 thousand of Euros for the year ended December 31, 2024 and 6,865 thousand of Euros for the full year ended December 31, 2023.
NOTE: Translated for convenience of the reader to U.S. dollars at the 2024 average twelve months’ exchange rate of 1 Euro = 1.0790 USD, and 2023 average twelve months exchange rate of 1 Euro = 1.0827 USD
EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
twelve months ended December 31, 2024
(Amounts in thousands of Euros)
| | | | | | | | | | | | | | | | | | | | |
| | HIFU | ESWL | Distribution | Reconciling | Total After | ||||||||||||||
| | | Division | | | | Division | | | | Division | | | | Items | | Consolidation | | | |
| Sales of goods | 14,825 | 3,481 | 25,731 | — | 44,037 | | |||||||||||||
| Net sales of RPP and leases | 6,273 | 1,033 | 304 | — | 7,610 | | |||||||||||||
| Sales of spare parts, supplies and services | 2,741 | 4,468 | 5,258 | — | 12,468 | | |||||||||||||
| TOTAL REVENUES | 23,839 | 8,982 | 31,293 | — | 64,114 | | |||||||||||||
| GROSS PROFIT (% of Net Sales) | 12,272 | 51.5 | % | 3,486 | 38.8 | % | 10,798 | 34.5 | % | — | 26,556 | 41.4 | % | ||||||
| Research & development expenses | (6,693) | (365) | (668) | — | (7,726) | | |||||||||||||
| Selling, general & administrative expenses | (23,038) | (1,911) | (10,700) | (3,714) | (39,364) | | |||||||||||||
| OPERATING PROFIT (LOSS) | (17,459) | 1,210 | (571) | (3,714) | (20,534) | |
NOTE: Reconciling Items include headquarters costs.
Attachment
FAQ
What were EDAP's HIFU revenue results for Q4 and full-year 2024?
How much did EDAP's U.S. Focal One HIFU procedures grow in 2024?
What was EDAP's Q4 2024 gross profit margin and net loss?
What new treatment approval did EDAP's Focal One receive in 2025?
What is EDAP's cash position as of December 31, 2024?
