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EDAP TMS SA (NASDAQ: EDAP) is a global leader in therapeutic ultrasound with over 30 years of experience. The company develops, manufactures, promotes, and distributes minimally-invasive medical devices for urology using advanced ultrasound technology. With a robust presence worldwide through a network of corporate offices, subsidiaries, and distribution partners, EDAP TMS is committed to innovation and excellence.
EDAP TMS operates through three main divisions:
- HIFU (High-Intensity Focused Ultrasound): This division focuses on the development and marketing of devices for the non-invasive destruction of tumors. Key products include Ablatherm, Ablatherm Fusion, and the Focal One, which is the latest addition designed for ideal focal therapy of localized prostate cancer.
- ESWL (Extracorporeal ShockWave Lithotripsy): This division manufactures and services the Sonolith range of lithotripters, which are used for the treatment of kidney stones.
- Distribution: This division markets complementary products such as lasers, micro-ultrasound systems, and other medical devices from third-party suppliers.
EDAP TMS is known for its strong patent portfolio thanks to continuous investment in research and development. The company collaborates with globally acclaimed medical research institutions to push the boundaries of medical technology. Financially, EDAP TMS reported a gross profit of EUR 24.4 million (USD 26.4 million) for the year ending December 31, 2023, reflecting a slight increase from the previous year. However, the gross profit margin declined due to inflationary pressures and investments in U.S. operations to support long-term revenue growth.
Recent achievements include the launch of the Focal One and strategic partnerships to expand its product reach. The company’s commitment to innovation and patient care makes it a significant player in the medical device industry.
EDAP TMS SA appointed Ryan Rhodes as CEO of its U.S. subsidiary, aiming to boost U.S. expansion. Rhodes brings 14 years of experience from Intuitive Surgical, where he advanced robotic surgery globally. His leadership is expected to drive the adoption of EDAP's Focal One technology for prostate cancer treatment, leveraging recent reimbursement coverage and clinical evidence. Chairman Marc Oczachowski emphasized the need for innovative therapies to improve cancer care standards, with Rhodes expressing optimism about future growth opportunities.
EDAP TMS SA reported a strong first quarter of 2021, generating revenues of EUR 10.3 million (USD 12.4 million), a 35.4% increase year-over-year. The company achieved a gross margin of 42.4% and reported a net income of EUR 0.8 million (USD 0.9 million). The revenue from the Distribution business doubled, reaching EUR 5.6 million (USD 6.7 million). Despite a 6.2% decline in HIFU revenue, EDAP maintains a strong cash position of EUR 24.4 million (USD 28.6 million) as of March 31, 2021, bolstered by a recent $28 million public offering.
EDAP TMS SA (Nasdaq: EDAP) will release its first-quarter financial results for the period ending March 31, 2021, on May 11, 2021, after market close. A conference call and webcast will follow on May 12, 2021, at 8:30 am EDT, featuring remarks from Marc Oczachowski, CEO, and François Dietsch, CFO. EDAP TMS is a leader in robotic energy-based therapies and develops innovative medical devices for prostate cancer treatment. The company aims to provide comprehensive solutions from diagnosis to treatment within the therapeutic ultrasound market.
EDAP TMS S.A. (NASDAQ: EDAP) announced an offering of American Depositary Shares (ADS) at $6.75 per share, totaling 4,150,000 ADSs for approximately $28 million. The offering is expected to close on April 27, 2021, pending customary conditions. Piper Sandler is the sole book-running manager, while B. Riley Securities and Lake Street Capital Markets serve as co-managers. The offering is registered with the SEC, and a prospectus supplement will be filed. This press release does not constitute an offer to sell or solicit offers to buy these securities in any jurisdiction where such actions would be unlawful.
EDAP TMS S.A. announced a follow-on public offering of its American Depositary Shares (ADSs), each representing one ordinary share. The offering is managed by Piper Sandler, with a shelf registration filed with the SEC. The company estimates total revenues between €10.0 million and €10.4 million for Q1 2021, up from €7.6 million in the same quarter of 2020. Gross margin is expected between 40% and 44%, and cash and cash equivalents stand at approximately €24.4 million. This press release cautions investors about reliance on preliminary estimates and market risks.
EDAP TMS SA reported strong fourth quarter 2020 results with revenue of EUR 15.4 million (USD 18.3 million), a 28% increase year-over-year. The company's HIFU revenue surged by 51%, driven by increased demand for its Focal One system and partnerships with notable healthcare institutions like UCSF and Cleveland Clinic. Despite an overall revenue decline of 7% for the full year 2020 due to COVID-19, EDAP maintained profitability with a cash position of EUR 24.7 million (USD 30.2 million). The company continues to focus on expanding its market presence in robotic energy-based therapies.
EDAP TMS SA (Nasdaq: EDAP) will release its financial results for the fourth quarter and year ended December 31, 2020 on March 30, 2021, after market close. A conference call led by CEO Marc Oczachowski and CFO François Dietsch is scheduled for March 31, 2021, at 8:30 AM EDT. The call will discuss key financial metrics and developments related to the company’s innovative medical devices, enhancing its position in therapeutic ultrasound.
EDAP TMS SA (Nasdaq: EDAP) announces a partnership with Medical Technology Partners and Argenta Advisors to enhance market access for its Focal One high intensity focused ultrasound (HIFU) procedure. This collaboration aims to expand insurance coverage for Medicare and commercially insured patients following the establishment of a Category 1 CPT code effective January 1, 2021. The initiative is expected to increase the accessibility of Focal One HIFU in prostate cancer treatment, addressing significant unmet needs in the healthcare landscape.
EDAP TMS reported a record revenue of EUR 15.3 million ($18.3 million) for Q4 2020, a 28% increase from Q4 2019. This growth was fueled by a 50% rise in HIFU device sales, with eight devices sold during the quarter. Despite the ongoing COVID-19 pandemic, the company experienced sequential quarterly revenue growth throughout 2020. However, the total revenue for 2020 is projected at EUR 41.6 million ($47.8 million), a 7% decline compared to 2019 due to pandemic-related restrictions. The full-year results will be disclosed in March 2021.
EDAP TMS SA announced that Marc Oczachowski, President and CEO, will participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference on January 20, 2021, at 10:00 a.m. ET. An audio webcast will be available for replay on the EDAP investor website for 90 days. EDAP is recognized as a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices for various conditions, including prostate cancer. The company’s Robotic HIFU devices and ExactVu™ Micro-Ultrasound are highlighted innovations in their product lineup.