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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 reported a revenue increase of 22.5% for the first half of 2021, totaling EUR 20.7 million (USD 24.8 million). Despite strong growth in U.S. HIFU treatment volumes, the HIFU business revenue declined by 15.1% year-over-year. Net income improved to EUR 0.4 million (USD 0.4 million), compared to a net loss of EUR 1.5 million in the prior year. The CMS advisory panel recommended increasing HIFU reimbursement rates significantly for 2022, which could boost future sales. The company maintained a robust cash balance of EUR 45 million (USD 53.3 million) as of June 30, 2021.
EDAP TMS SA (Nasdaq: EDAP) reported preliminary second quarter 2021 revenue of approximately EUR 10.4 million (USD $12.4 million), an 11.8% increase year-over-year, with first half revenue rising 22.5% to EUR 20.7 million (USD $24.8 million). U.S. High-Intensity Focused Ultrasound (HIFU) treatment volumes surged 79% compared to 2020, signaling strong adoption in the market. The company ended the quarter with cash and cash equivalents of EUR 45 million (USD $53.3 million) and announced the appointment of Ryan Rhodes as CEO of its U.S. subsidiary. A detailed financial report is expected on August 25, 2021.
EDAP TMS SA (Nasdaq: EDAP) announces significant achievements in 2021, including a successful secondary offering that raised approximately $28 million to enhance its U.S. market capabilities. The company has made notable sales to prominent health institutions like Mt. Sinai and Cleveland Clinic. The hiring of Ryan Rhodes as CEO of the U.S. subsidiary aims to accelerate high intensity focused ultrasound (HIFU) adoption in prostate cancer treatment. Additionally, a Category 1 CPT code was established for HIFU reimbursement, effective January 1, 2021.
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.
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