EDAP Reports Second Quarter 2024 Financial Results
EDAP TMS SA reported record Q2 2024 total worldwide revenue of EUR 15.8 million (USD 17.0 million), a 10.6% increase over Q2 2023. The company experienced strong U.S. Focal One® HIFU procedure growth of 63% year-over-year. Key highlights include:
- Five Focal One systems placed in Q2, including two at NCI-designated comprehensive cancer centers
- Strong year-over-year procedure growth indicating increasing adoption of robotic HIFU
- Appointment of new board member and strengthened European commercial leadership
- Presentation of final HIFI study results at AUA 2024, showing Focal One as effective as radical prostatectomy for localized prostate cancer
- Interim results from Phase 3 endometriosis study and approval to initiate Phase 1-2 BPH clinical trial
Despite revenue growth, the company reported an operating loss of EUR 6.1 million for Q2 2024, compared to EUR 4.2 million in Q2 2023, due to increased investments in commercial and R&D functions.
EDAP TMS SA ha riportato un fatturato mondiale record per il secondo trimestre del 2024 pari a 15,8 milioni di euro (17,0 milioni di dollari), con un incremento del 10,6% rispetto al secondo trimestre del 2023. L'azienda ha registrato una forte crescita delle procedure Focal One® HIFU negli Stati Uniti, con un aumento del 63% rispetto all'anno precedente. I punti salienti includono:
- Cinque sistemi Focal One installati nel secondo trimestre, di cui due presso centri oncologici completi designati dal NCI
- Forte crescita annuale delle procedure che indica un crescente utilizzo della HIFU robotica
- Nomina di un nuovo membro del consiglio e rafforzamento della leadership commerciale europea
- Presentazione dei risultati finali dello studio HIFI all'AUA 2024, che dimostrano l'efficacia di Focal One rispetto alla prostatectomia radicale per il cancro della prostata localizzato
- Risultati intermedi dello studio di fase 3 sull'endometriosi e approvazione per avviare la sperimentazione clinica di fase 1-2 per l'IPB
Nonostante la crescita dei ricavi, l'azienda ha registrato una perdita operativa di 6,1 milioni di euro per il secondo trimestre del 2024, rispetto a 4,2 milioni di euro nel secondo trimestre del 2023, a causa dell'aumento degli investimenti nelle funzioni commerciali e di R&S.
EDAP TMS SA informó un ingreso mundial récord para el segundo trimestre de 2024 de 15,8 millones de euros (17,0 millones de dólares), lo que representa un aumento del 10,6% en comparación con el segundo trimestre de 2023. La compañía experimentó un crecimiento fuerte en los procedimientos Focal One® HIFU en EE. UU. de un 63% interanual. Los aspectos destacados incluyen:
- Se colocaron cinco sistemas Focal One en el segundo trimestre, incluidos dos en centros de cáncer completos designados por el NCI
- Fuerte crecimiento interanual en los procedimientos, lo que indica una creciente adopción de HIFU robótica
- Nombramiento de un nuevo miembro de la junta y fortalecimiento del liderazgo comercial en Europa
- Presentación de los resultados finales del estudio HIFI en AUA 2024, mostrando que Focal One es tan efectivo como la prostatectomía radical para el cáncer de próstata localizado
- Resultados intermedios del estudio de fase 3 sobre endometriosis y aprobación para iniciar ensayos clínicos de fase 1-2 sobre HBP
A pesar del crecimiento en los ingresos, la compañía reportó una pérdida operativa de 6,1 millones de euros para el segundo trimestre de 2024, en comparación con 4,2 millones de euros en el segundo trimestre de 2023, debido al aumento de las inversiones en funciones comerciales e I+D.
EDAP TMS SA는 2024년 2분기 전 세계 총 수익이 1580만 유로 (1700만 달러)에 달하며, 이는 2023년 2분기 대비 10.6% 증가한 기록임을 보고했습니다. 이 회사는 미국에서 Focal One® HIFU 절차가 전년 대비 63% 성장하며 강력한 실적을 기록했습니다. 주요 하이라이트는 다음과 같습니다:
- 2분기에 다섯 대의 Focal One 시스템이 설치되었으며, 그 중 두 대는 NCI 지정 종합 암 센터에 배치됨
- 로봇 HIFU의 채택 증가를 나타내는 전년 대비 강력한 절차 성장
- 새로운 이사 임명 및 유럽 상업 리더십 강화
- AUA 2024에서 HIFI 연구 결과 최종 발표, Focal One이 국소 전립선암에 대한 근치적 전립선 절제술만큼 효과적임을 보여줌
- 자궁내막증 연구 3상 중간 결과 및 BPH 임상 시험 1-2상 시행 승인을 받음
수익 성장에도 불구하고, 회사는 2024년 2분기에 610만 유로의 운영 손실을 보고했으며, 이는 2023년 2분기의 420만 유로에 비해 증가한 것입니다. 상업 및 연구 개발 기능에 대한 투자가 증가했기 때문입니다.
EDAP TMS SA a annoncé un chiffre d'affaires mondial record pour le deuxième trimestre 2024 de 15,8 millions d'euros (17,0 millions de dollars), soit une augmentation de 10,6 % par rapport au deuxième trimestre 2023. L'entreprise a connu une forte croissance des procédures Focal One® HIFU aux États-Unis, avec une augmentation de 63 % par rapport à l'année précédente. Les points forts incluent :
- Cinq systèmes Focal One ont été installés au cours du deuxième trimestre, dont deux dans des centres de cancérologie complets désignés par le NCI
- Forte croissance des procédures d'une année sur l'autre, indiquant une adoption croissante de HIFU robotique
- Nommer un nouveau membre du conseil et renforcer la direction commerciale européenne
- Présentation des résultats finaux de l'étude HIFI lors de l'AUA 2024, montrant que Focal One est aussi efficace que la prostatectomie radicale pour le cancer de la prostate localisé
- Résultats intermédiaires de l'étude de phase 3 sur l'endométriose et approbation pour initier un essai clinique de phase 1-2 pour l'hyperplasie bénigne de la prostate (HBP)
Malgré la croissance des revenus, l'entreprise a enregistré une perte d'exploitation de 6,1 millions d'euros pour le deuxième trimestre 2024, contre 4,2 millions d'euros au deuxième trimestre 2023, en raison de l'augmentation des investissements dans les fonctions commerciales et de recherche et développement.
EDAP TMS SA meldete einen weltweiten Rekordumsatz von 15,8 Millionen Euro (17,0 Millionen USD) für das zweite Quartal 2024, was einem Anstieg von 10,6 % im Vergleich zum zweiten Quartal 2023 entspricht. Das Unternehmen verzeichnete ein starkes Wachstum der Focal One® HIFU-Verfahren in den USA von 63 % im Jahresvergleich. Zu den wichtigsten Highlights gehören:
- Fünf Focal One-Systeme wurden im zweiten Quartal installiert, darunter zwei an vom NCI zertifizierten umfassenden Krebszentren
- Starker Anstieg der Verfahren im Jahresvergleich, was auf eine zunehmende Akzeptanz der robotergestützten HIFU hinweist
- Ernennung eines neuen Vorstandsmitglieds und Stärkung der europäischen kommerziellen Führung
- Präsentation der endgültigen Ergebnisse der HIFI-Studie auf der AUA 2024, die zeigt, dass Focal One ebenso effektiv wie eine radikale Prostatektomie bei lokalisiertem Prostatakrebs ist
- Zwischenberichte aus der Phase-3-Studie zur Endometriose und Genehmigung zur Einleitung der Phase-1-2-Studie zur benigne Prostatahyperplasie (BPH)
Trotz des Umsatzwachstums berichtete das Unternehmen von einem Betriebsverlust von 6,1 Millionen Euro im zweiten Quartal 2024, verglichen mit 4,2 Millionen Euro im zweiten Quartal 2023, aufgrund erhöhter Investitionen in die kommerziellen und F&E-Funktionen.
- Record Q2 2024 total worldwide revenue of EUR 15.8 million, up 10.6% year-over-year
- Strong 63% year-over-year growth in U.S. Focal One HIFU procedures
- Five Focal One systems placed in Q2, including two at NCI-designated comprehensive cancer centers
- 29.4% year-over-year growth in worldwide disposables revenues
- Positive final results from HIFI study presented at AUA 2024, supporting Focal One adoption
- Approval to initiate Phase 1-2 Clinical Trial for BPH treatment using Focal One Robotic HIFU
- Operating loss increased to EUR 6.1 million in Q2 2024 from EUR 4.2 million in Q2 2023
- Gross profit margin decreased to 37.5% in Q2 2024 from 39.6% in Q2 2023
- Net loss increased to EUR 6.1 million in Q2 2024 from EUR 4.7 million in Q2 2023
- Cash and cash equivalents decreased to EUR 30.2 million as of June 30, 2024, from EUR 43.5 million as of December 31, 2023
- Primary endpoint not met in Phase 3 endometriosis study interim results
Insights
EDAP's Q2 2024 results show mixed signals. While the company achieved record quarterly revenue of
The company's HIFU business saw strong
EDAP's cash position decreased to
The final results from the HIFI study, presented at major urology conferences, are a significant milestone for EDAP. The study demonstrates that Focal One robotic HIFU is at least as effective as radical prostatectomy for localized prostate cancer, with potential for improved functional outcomes. This data could drive broader adoption of HIFU technology in prostate cancer treatment.
The company's expansion into new indications is noteworthy. The interim results from the Phase 3 endometriosis study showed an excellent safety profile, although the primary endpoint of reduced acute pelvic pain was not met at three months. The initiation of a Phase 1-2 trial for Benign Prostate Hyperplasia (BPH) represents another potential growth avenue.
The increasing adoption of Focal One by National Cancer Institute-designated comprehensive cancer centers underscores the growing acceptance of HIFU technology in leading medical institutions. This trend, coupled with the
- Record Q2 2024 total worldwide revenue of EUR 15.8 million (USD 17.0 million) increased
10.6% over Q2 2023 - Record first half 2024 total worldwide revenue of EUR 30.7 million (USD 33.1 million) increased
5.6% over first half 2023 - Strong Q2 2024 U.S. Focal One® HIFU procedure growth of +
63% year-over-year - Company to host conference call and webcast today, August 28th, at 8:30 a.m. EDT
LYON, France, August 28, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the second quarter of 2024.
“We continue to see growing demand for our proprietary and leading Focal One robotic HIFU technology platform. In the second quarter, we placed five Focal One systems, which included placements with two additional National Cancer Institute (NCI) designated comprehensive cancer centers. A growing number of top tier cancer research and treatment centers continue to adopt Focal One to help patients manage their prostate cancer, which reflects the innovation and positive clinical outcomes of our leading robotic HIFU platform,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “We also experienced strong year over year procedure growth, which points towards the growing adoption of robotic HIFU amongst urologists across both academic and community hospitals.
“There is also an increasing body of clinical evidence that supports the continued adoption of Focal One as a frontline treatment for localized prostate cancer. The final results from the groundbreaking, prospective HIFI study were presented at this year’s EAU and AUA scientific meetings. This data clearly demonstrates that Focal One robotic HIFU is at least as effective as radical prostatectomy as a first line treatment for localized disease, but with the added potential for improved functional outcomes with respect to both the preservation of urinary continence and sexual function. We believe the HIFI study helps pave the way for broader adoption of our HIFU technology. We expect the results from the HIFI study, in combination with the recent investments in our commercial team, should help drive strong adoption of Focal One throughout the second half of the year.”
Business Update
- On August 27, 2024, Marc Oczachowski resigned as Chairman of the Company’s Board of Directors in order to allow him more time to focus on other endeavors. In order to provide for a smooth transition for the Board of Directors, the effective date of the resignation will be September 30, 2024.
- On July 8, 2024, the Company appointed Fran Schulz to its Board of Directors. Ms. Schulz is a seasoned executive with over 35 years of experience with EY who has spent her career working with large public and emerging private companies throughout the life sciences industry. She has deep experience guiding companies to execute a broad range of corporate deals including collaboration agreements, corporate spin-offs, reorganizations, and mergers and acquisitions, with personal involvement in over 100 total equity and debt transactions, raising over
$15 billion in aggregate.
- On August 6, 2024, the Company announced that Focal One Robotic HIFU was featured at the 41st World Congress of Endourology and Uro-Technology (WCET 2024) meeting, which took place in Seoul, Korea, from August 12-16, 2024. The Company had a significant presence at WCET 2024, reflecting the increasing trend amongst urologists for utilizing non-invasive HIFU technology for the management of prostate cancer. In addition to providing hands-on Focal One simulations for urologists in attendance, this year’s WCET meeting included a featured semi-live Focal One clinical procedure conducted by Dr. Tarik Benidir, Clinical Assistant Professor from the University of Florida.
- On June 3, 2024, the Company appointed Damien Desmedt and Alexander Fromm to further strengthen the EDAP’s European and Middle Eastern commercial leadership. Mr. Desmedt was appointed Vice President of Sales for Europe, Middle East, Africa, and India (EMEAI), and Mr. Fromm was appointed General Manager for Switzerland and will oversee several strategic European territories.
- On May 6, 2024, the Company announced that final results from a large, prospective, multicenter, non-inferiority study, the HIFI Study, comparing Focal One® high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) were presented at the 119th American Urological Association Annual Meeting (AUA 2024), which took place from May 3-6, 2024, in San Antonio, Texas, USA. Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the HIFI Study, highlighted the final results from the study during an oral presentation at the AUA plenary session, “Paradigm-shifting, Practice-changing Clinical Trials in Urology”.
Clinical Pipeline Update
Endometriosis Program
- On July 19, 2024, the Company announced interim results from its Phase 3 study evaluating robotic HIFU for the treatment of deep infiltrating endometriosis. The interim data show that robotic HIFU therapy continues to maintain an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies in patients with deep infiltrating endometriosis. At three months post procedure, the study’s primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met. Significant improvements were observed across primary and secondary outcome measures (endometriosis and digestive symptoms) across the entire study population at three months. As measured by MRI, patients receiving robotic HIFU therapy experienced higher volume reductions in the endometriosis nodule as compared to patients in the Sham treatment arm. The Phase 3 study continues per protocol, with several patients initially in the Sham treatment arm having elected and already received HIFU therapy after their pelvic pain returned to baseline levels.
Benign Prostate Hyperplasia (BPH) Program
- On July 26, 2024, the Company received approval from the French National Agency for Medicines and Health Products Safety (ANSM) to initiate a Phase 1-2 Clinical Trial investigating Focal One Robotic HIFU in the treatment of Benign Prostate Hyperplasia (BPH). This company-sponsored multicenter study is designed as a 2-phase study: the first phase will take place at two 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. This first phase is designed as a HIFU dose escalation protocol aimed at defining the optimal treatment parameters to effectively treat BPH and its related symptoms with minimal side effects. The second phase 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 defined during the first phase of the study.
Upcoming Meetings and Events H.C. Wainwright Healthcare Conference, Tuesday, September 10th, in New York City
Second Quarter 2024 Results
Total worldwide revenue for the second quarter of 2024 was EUR 15.8 million (USD 17.0 million), an increase of
Total revenue in the HIFU business for the second quarter of 2024 was EUR 4.8 million (USD 5.2 million), as compared to EUR 4.9 million (USD 5.3 million) for the second quarter of 2023. Three Focal One systems were sold during the second quarter of 2024 versus four systems sold in the second quarter of 2023. Despite the 1 unit decrease year over year, the Company recorded a
Total revenue in the Distribution business for the second quarter of 2024 was EUR 8.7 million (USD 9.4 million), as compared to EUR 7.2 million (USD 7.8 million) for the second quarter of 2023. The increase in Distribution revenue was driven primarily by 12 ExactVu units sold during the second quarter of 2024 as compared to 9 units sold during the second quarter of 2023.
Total revenue in the LITHO business for the second quarter of 2024 was EUR 2.3 million (USD 2.5 million), as compared to EUR 2.2 million (USD 2.4 million) for the second quarter of 2023. The increase in LITHO revenue was driven by 3 lithotripsy units sold in the second quarter of 2024 as compared to 2 units sold in the second quarter of 2023.
Gross profit for the second quarter of 2024 was EUR 5.9 million (USD 6.4 million), compared to EUR 5.7 million (USD 6.1 million) for the year-ago period. Gross profit margin on net sales was
Operating expenses were 12.1 million euros (USD 13.0 million) for the second quarter, compared to 9.9 million euros (USD 10.7 million) for the same period in 2023. The increase in operating expenses was due to the continued investments made in the global commercial and R&D functions in anticipation of growing demand for Focal One.
Operating loss for the second quarter of 2024 was EUR 6.1 million (USD 6.6 million), compared to an operating loss of EUR 4.2 million (USD 4.6 million) in the second quarter of 2023.
Net loss for the second quarter of 2024 was EUR 6.1 million (USD 6.6 million), or EUR (0.16) per share, as compared to net loss of EUR 4.7 million (USD 5.1 million), or EUR (0.13) per share in the second quarter of 2023.
Year-to-Date Results
Total worldwide revenue for the six months ended June 30, 2024, was EUR 30.7 million (USD 33.1 million), an increase of
Total revenue in the HIFU business for the six months ended June 30, 2024, was EUR 10.6 million (USD 11.4 million), an increase of
Total revenue in the Distribution business for the six months ended June 30, 2024, was EUR 15.6 million (USD 16.8 million), a
Total revenue in the LITHO business for the six months ended June 30, 2024, was EUR 4.6 million (USD 4.9 million), a decrease of
Gross profit for the six months ended June 30, 2024, was EUR 12.3 million (USD 13.3 million), compared to EUR 11.7 million (USD 12.7 million), for the six months ended June 30, 2023. Gross profit margin on net sales was
Operating expenses were EUR 23.3 million (USD 25.1 million) for the six months ended June 30, 2024, compared to EUR 22.5 million (USD 24.3 million) for the same period in 2023.
Operating loss for the six months ended June 30, 2024, was EUR 11.0 million (USD 11.8 million), compared to an operating loss of EUR 10.8 million (USD 11.7 million) for the six months ended June 30, 2023.
Net loss for the six months ended June 30, 2024, was EUR 10.7 million (USD 11.5 million), or EUR (0.29) per share, as compared to a net loss of EUR 12.2 million (USD 13.2 million), or EUR (0.33) per share for the six months ended June 30, 2023.
As of June 30, 2024, the Company held cash and cash equivalents of EUR 30.2 million (USD 32.4 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 second quarter 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: Wednesday, August 28th @ 8:30am Eastern Time
Domestic: 1-877-300-8521
International: 1-412-317-6026
Passcode (Conf ID): 7219730
Call me™: LINK (will be activated 15 minutes prior to scheduled start time)
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1679882&tp_key=f499a45540
About EDAP TMS SA
A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, us.hifu-prostate.com and www.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 | |||||||
| June 30, | June 30, | June 30, | June 30, | |||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Euros | Euros | $US | $US | |||||
| Sales of medical equipment | 11,118 | 9,804 | 11,948 | 10,657 | ||||
| Net sales of RPP and leases | 1,886 | 1,751 | 2,027 | 1,903 | ||||
| Sales of spare parts, supplies and services | 2,787 | 2,724 | 2,995 | 2,961 | ||||
| TOTAL NET SALES | 15,791 | 14,278 | 16,970 | 15,522 | ||||
| Other revenues | — | — | — | — | ||||
| TOTAL REVENUES | 15,791 | 14,278 | 16,970 | 15,522 | ||||
| Cost of sales | (9,872) | (8,623) | (10,609) | (9,374) | ||||
| GROSS PROFIT | 5,919 | 5,655 | 6,361 | 6,148 | ||||
| Research & development expenses | (2,077) | (1,677) | (2,232) | (1,823) | ||||
| Selling, general & administrative expenses | (9,989) | (8,203) | (10,736) | (8,917) | ||||
| Total operating expenses | (12,066) | (9,880) | (12,967) | (10,740) | ||||
| OPERATING PROFIT (LOSS) | (6,147) | (4,225) | (6,606) | (4,592) | ||||
| Interest (expense) income, net | 190 | 255 | 204 | 278 | ||||
| Currency exchange gains (loss), net | (49) | (508) | (52) | (552) | ||||
| LOSS BEFORE INCOME TAXES | (6,005) | (4,477) | (6,454) | (4,867) | ||||
| Income tax (expense) credit | (127) | (221) | (136) | (240) | ||||
| NET LOSS | (6,132) | (4,698) | (6,590) | (5,107) | ||||
| Loss per share – Basic and diluted | (0.16) | (0.13) | (0.18) | (0.14) | ||||
| Avg number of shares used in computation of basic and diluted EPS | 37,205,307 | 36,985,934 | 37,205,307 | 36,985,934 | ||||
NOTE: Translated to U.S. dollars at the 2024 average three months’ exchange rate of 1 Euro = 1.0747 USD, and 2023 average three months’ exchange rate of 1 Euro = 1.0871 USD
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of Euros and U.S. Dollars, except per share data)
| Six Months Ended | Six Months Ended | |||||||
| June 30 | June 30 | June 30 | June 30 | |||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Euros | Euros | $US | $US | |||||
| Sales of medical equipment | 21,085 | 20,123 | 22,735 | 21,782 | ||||
| Net sales of RPP and leases | 3,661 | 3,329 | 3,948 | 3,604 | ||||
| Sales of spare parts, supplies and services | 5,952 | 5,622 | 6,418 | 6,085 | ||||
| TOTAL NET SALES | 30,698 | 29,074 | 33,102 | 31,472 | ||||
| Other revenues | — | — | — | — | ||||
| TOTAL REVENUES | 30,698 | 29,074 | 33,102 | 31,472 | ||||
| Cost of sales | (18,394) | (17,387) | (19,834) | (18,821) | ||||
| GROSS PROFIT | 12,304 | 11,687 | 13,267 | 12,651 | ||||
| Research & development expenses | (4,146) | (3,135) | (4,470) | (3,393) | ||||
| Selling, general & administrative expenses | (19,121) | (19,333) | (20,618) | (20,928) | ||||
| Total operating expenses | (23,267) | (22,467) | (25,088) | (24,321) | ||||
| OPERATING PROFIT (LOSS) | (10,963) | (10,781) | (11,821) | (11,670) | ||||
| Interest (expense) income, net | 335 | 511 | 361 | 554 | ||||
| Currency exchange gains (loss), net | 187 | (1,653) | 202 | (1,789) | ||||
| LOSS BEFORE INCOME TAXES | (10,440) | (11,922) | (11,258) | (12,905) | ||||
| Income tax (expense) credit | (238) | (267) | (257) | (289) | ||||
| NET LOSS | (10,678) | (12,189) | (11,514) | (13,194) | ||||
| Loss per share – Basic and diluted | (0.29) | (0.33) | (0.31) | (0.36) | ||||
| Average number of shares used in computation of basic and diluted EPS | 37,104,348 | 36,954,439 | 37,104,348 | 36,954,439 | ||||
NOTE: Translated to U.S. dollars at the 2024 average six months’ exchange rate of 1 Euro = 1.0783 USD, and 2023 average six months’ exchange rate of 1 Euro = 1.0825 USD
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of Euros and U.S. Dollars)
| June 30, | December 31, | June 30, | December 31, | ||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| Euros | Euros | $US | $US | ||||||||||
| Cash, cash equivalents and short-term investments | 30,212 | 43,471 | 32,361 | 48,087 | |||||||||
| Accounts receivable, net | 18,214 | 19,238 | 19,510 | 21,281 | |||||||||
| Inventory | 17,962 | 15,112 | 19,240 | 16,717 | |||||||||
| Other current assets | 937 | 659 | 1,004 | 729 | |||||||||
| TOTAL CURRENT ASSETS | 67,326 | 78,480 | 72,114 | 86,814 | |||||||||
| Property, plant and equipment, net | 9,976 | 8,193 | 10,686 | 9,063 | |||||||||
| Goodwill | 2,412 | 2,412 | 2,583 | 2,668 | |||||||||
| Other non-current assets | 2,453 | 2,464 | 2,628 | 2,725 | |||||||||
| TOTAL ASSETS | 82,167 | 91,548 | 88,011 | 101,270 | |||||||||
| Accounts payable & other accrued liabilities | 18,133 | 18,435 | 19,422 | 20,392 | |||||||||
| Deferred revenues, current portion | 4,828 | 4,049 | 5,171 | 4,479 | |||||||||
| Short term borrowing | 1,780 | 2,466 | 1,907 | 2,728 | |||||||||
| Other current liabilities | 2,705 | 2,646 | 2,897 | 2,927 | |||||||||
| TOTAL CURRENT LIABILITIES | 27,445 | 27,596 | 29,397 | 30,526 | |||||||||
| Obligations under operating and finance leases non-current | 2,246 | 1,315 | 2,406 | 1,454 | |||||||||
| Long term debt, non-current | 1,256 | 1,997 | 1,346 | 2,209 | |||||||||
| Deferred revenues, non-current | 548 | 643 | 587 | 712 | |||||||||
| Other long-term liabilities | 3,036 | 3,075 | 3,252 | 3,402 | |||||||||
| TOTAL LIABILITIES | 34,531 | 34,626 | 36,987 | 38,304 | |||||||||
| TOTAL SHAREHOLDERS’ EQUITY | 47,636 | 56,922 | 51,024 | 62,966 | |||||||||
| TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY | 82,167 | 91,548 | 88,011 | 101,270 | |||||||||
NOTE: Translated to U.S. dollars at the exchange rate of 1 Euro = 1.0711 USD, on June 30, 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)
| Six Months Ended | Twelve Months Ended | Six Months Ended | Twelve Months Ended | |||||
| June 30, | December 31, | June 30, | December 31, | |||||
| 2024 | 2023 | 2024 | 2023 | |||||
| (Euros) | (Euros) | ($US) | ($US) | |||||
| NET LOSS | (10,678) | (21,178) | (11,514) | (22,930) | ||||
| Adjustments to reconcile net loss to net cash provided by operating activities(1) | 2,935 | 9,403 | 3,164 | 10,181 | ||||
| OPERATING CASH FLOW | (7,744) | (11,775) | (8,350) | (12,749) | ||||
| Net Decrease in operating assets and liabilities | (2,192) | (2,903) | (2,364) | (3,144) | ||||
| NET CASH USED IN OPERATING ACTIVITIES | (9,936) | (14,678) | (10,714) | (15,892) | ||||
| Additions to capitalized assets produced by the company and other capital expenditures | (1,854) | (4,344) | (1,999) | (4,704) | ||||
| NET CASH USED IN INVESTING ACTIVITIES | (1,854) | (4,344) | (1,999) | (4,704) | ||||
| NET CASH USED IN FINANCING ACTIVITIES | (1,433) | (911) | (1,545) | (986) | ||||
| NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (35) | 268 | (1,467) | 2,130 | ||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (13,258) | (19,666) | (15,726) | (19,452) |
(1) including share-based compensation expenses of Euro 1,502 thousand for the six months ended June 30, 2024 and Euro 6,865 thousand for the full year ended December 31, 2023.
NOTE: Translated to U.S. dollars at the 2024 average six months’ exchange rate of 1 Euro = 1.0783 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
Six months ended June 30, 2024
(Amounts in thousands of Euros)
| HIFU | ESWL | Distribution | Reconciling | Total After | |||||||||||||||
| Division | Division | Division | Items | Consolidation | |||||||||||||||
| Sales of goods | 6,335 | 1,718 | 13,032 | — | 21,085 | ||||||||||||||
| Sales of RPPs & leases | 3,004 | 533 | 124 | — | 3,661 | ||||||||||||||
| Sales of spare parts & services | 1,239 | 2,301 | 2,412 | — | 5,952 | ||||||||||||||
| TOTAL NET SALES | 10,577 | 4,553 | 15,569 | — | 30,698 | ||||||||||||||
| Other revenues | — | — | — | — | — | ||||||||||||||
| TOTAL REVENUES | 10,577 | 4,553 | 15,569 | — | 30,698 | ||||||||||||||
| GROSS PROFIT (% of Net Sales) | 4,993 | 47.2 | % | 2,034 | 44.7 | % | 5,278 | 33.9 | % | — | 12,304 | 40.1 | % | ||||||
| Research & development expenses | (3,623) | (216) | (307) | — | (4,146) | ||||||||||||||
| Selling, general & administrative expenses | (10,846) | (914) | (5,143) | (2,218) | (19,121) | ||||||||||||||
| OPERATING PROFIT (LOSS) | (9,477) | 904 | (173) | (2,218) | (10,963) |
Attachment
FAQ
What was EDAP's revenue for Q2 2024?
How many Focal One systems did EDAP place in Q2 2024?
What was the growth rate of U.S. Focal One HIFU procedures for EDAP in Q2 2024?
What were the results of the HIFI study for EDAP's Focal One presented at AUA 2024?
What was EDAP's operating loss for Q2 2024?
