EDAP TMS S A : Positive results from two studies reconfirm safety … – Marketscreener.com

- Positive results from two studies reconfirm safety and efficacy of Focal One -

- Company to host conference call and webcast today, Wednesday, May 17that 8:30 am EDT -

LYON, France, May 17, 2023 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today unaudited financial results for the first quarter ended March 31, 2023.

"After achieving record results in the fourth quarter of 2022, we continued to see growing demand through the first quarter of 2023, with our strongest Q1 revenue performance on record," said Ryan Rhodes, Chief Executive Officer of EDAP. "We placed seven Focal One units, including six equipment sales and one operating lease. Based upon the positive feedback from urologists, particularly at this year's recent EAU & AUA meetings, we expect momentum for the Focal One platform to continue throughout 2023, driven by our state-of-the-art technology, our positive clinical outcomes demonstrating excellent oncologic control, and our world-class sales and customer support team."

"Beyond our commercial performance, we also announced positive results from two clinical studies utilizing Focal One, both conducted at leading academic urology centers. Results from these studies clearly demonstrate the safety, efficacy, and benefits of Focal One that support both continued growth and increased utilization of the technology. As Focal One continues to grow, we are also making commercial progress in other areas. We recently received approval of ExactVuTM micro-ultrasound in Japan, representing a significant regulatory milestone for EDAP that introduces this innovative platform to the world's second largest medical device market. As we continue to invest in expanding both clinical and commercial activities to drive bottom line performance, we maintain a strong cash position to support both short and long-term growth."

Business Update:

First Quarter 2023 Results

Total revenue for the first quarter 2023 was EUR 14.8 million (USD 15.9 million), an increase of 13.8% as compared to total revenue of EUR 13.0 million (USD 14.5 million) for the same period in 2022.

Total revenue in the HIFU business for the first quarter 2023 was EUR 5.3 million (USD 5.7 million), an increase of 39.5% as compared to EUR 3.8 million (USD 4.3 million) for the first quarter of 2022. The increase was driven by six Focal One units sold in the first quarter 2023 versus four units sold in the first quarter 2022.

Total revenue in the LITHO business for the first quarter 2023 was EUR 2.8 million (USD 3.0 million), as compared to EUR 2.2 million (USD 2.5 million) for the first quarter of 2022. The improvement was driven by four lithotripsy unit sold in the first quarter of 2023 as compared to one unit sold in the first quarter of 2022.

Total revenue in the Distribution business for the first quarter 2023 was EUR 6.8 million (USD 7.3 million), as compared to EUR 7.0 million (USD 7.8 million) for the first quarter of 2022. The decrease was driven primarily by eight ExactVu units sold during the first quarter of 2023 as compared to nine units sold during the first quarter of 2022.

Gross profit for the first quarter 2023 was EUR 6.0 million (USD 6.5 million), compared to EUR 5.8 million (USD 6.4 million) for the year-ago period. Gross profit margin on net sales was 40.8% in the first quarter of 2023, compared to 44.3% in the year-ago period. The decrease in gross profit rate year-over-year was primarily due to investments in service and applications in the U.S.

Operating expenses were EUR 12.6 million (USD 13.6 million) for the first quarter of 2023, compared to EUR 5.9 million (USD 6.6 million) for the same period in 2022. The significant increase in operating expenses is mainly due to the ongoing build-out of the U.S. team and commercial infrastructure, and non-recurring expenses linked to the leadership succession plan.

Operating loss for the first quarter of 2023 was EUR 6.6 million (USD 7.1 million), compared to an operating loss of EUR 0.1 million (USD 0.1 million) in the first quarter of 2022.

Net loss for the first quarter of 2023 was EUR 7.5 million (USD 8.1 million), or EUR 0.2 per diluted share, as compared to net income of EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share in the year-ago period.

As of March 31, 2023, the company held cash and cash equivalents of EUR 58.3 million (USD 63.4 million) as compared to EUR 63.1 million (USD 67.5 million) as of December 31, 2022.

Conference Call

A conference call and webcast to discuss first quarter 2023 financial results will be hosted by Ryan Rhodes, Chief Executive Officer, Franois Dietsch, Chief Financial Officer and Ken Mobeck, Chief Financial Officer of the U.S. subsidiary, today Wednesday, May 17th, 2023 at 8:30am EDT. Please refer to the information below for conference call dial-in information and webcast registration.

About the Endo-HIFU-R1 Phase 2 Study

The Endo-HIFU-R1 Phase 2 study was designed and conducted to evaluate the safety and efficacy of therapeutic high-Intensity focused ultrasound (HIFU) for the treatment of rectal endometriosis with EDAP's Focal One Robotic HIFU device. At six-months follow up, of the 60 patients enrolled and treated with Focal One HIFU across four centers in France between August 2020 and March 2022, 96.7% demonstrated positive safety with no or non-significant adverse events (Clavien 1), 3.3% presented Clavien 2 complications and zero patients presented Clavien 3 complications. Additional endpoints included evaluation of the effect of HIFU treatment on endometriosis symptoms and Quality of Life (QoL). A significant decrease in endometriosis symptom level (acute pelvic pain, dyspareunia, diarrhea, constipation, rectal bleeding, false urges, tenesmus, rectal spams, posterior pelvic pain and asthenia) and an improvement in almost all evaluated QoL criteria (physical functioning, role limitation due to emotional problems, energy - fatigue, emotional well-being, social functioning, bodily pain, general health, and on physical and mental global score components) were observed at the first post-treatment evaluation at one month, and those benefits were maintained at three and six months following HIFU treatment. The study also blindly evaluated the evolution of nodule volume via MRI, with a significant reduction of the volume of lesions observed at six months. Results from the study were presented by study coordinator, Pr. Gil Dubernard of Croix Rousse University Hospital (Lyon, France) at the Paris Sant Femmes French Congress on Friday, January 27, 2023.

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 http://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)

NOTE: Translated for convenience of the reader to U.S. dollars at the 2023 average three months' noon buying rate of 1 Euro = 1.0777 USD, and 2022 average three months noon buying rate of 1 Euro = 1.1177 USD

EDAP TMS S.A.

UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS

(Amounts in thousands of Euros and U.S. Dollars)

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.0872 USD, on March 31, 2023 and at the noon buying rate of 1 Euro = 1.0697 USD, on December 31, 2022.

EDAP TMS S.A.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands of Euros)

(1) including share based compensation expenses for 2,660 thousand of Euros for the three months ended March 31, and 2,103 thousand of Euros for the full year ended December 31, 2022.

NOTE: Translated for convenience of the reader to U.S. dollars at the 2023 average three months' noon buying rate of 1 Euro = 1.0777 USD, and 2022 average twelve months noon buying rate of 1 Euro = 1.0519 USD

EDAP TMS S.A.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

three months ended March 31, 2023

(Amounts in thousands of Euros)

Disclaimer

Edap TMS SA published this content on 17 May 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 May 2023 10:40:10 UTC.

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