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EDAP Reports Fourth Quarter 2020 Results and Provides Operational Update

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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.

Positive
  • Q4 2020 revenue increased by 28% year-over-year to EUR 15.4 million (USD 18.3 million).
  • HIFU revenue grew 51% year-over-year.
  • Achieved operating profitability for both Q4 and full year 2020.
  • Strong cash position of EUR 24.7 million (USD 30.2 million) as of December 31, 2020.
  • Welcomed UCSF and Cleveland Clinic as new customers for Focal One.
Negative
  • Full year 2020 revenue decreased by 7% year-over-year to EUR 41.7 million (USD 47.8 million).
  • HIFU business revenue declined by 19% year-over-year.
  • LITHO business revenue fell by 9.2% year-over-year.
  • Gross profit margin decreased to 44.1% compared to 46.8% the previous year.
  • Generated record fourth quarter revenue of EUR 15.4 million (USD 18.3 million), an increase of 28% year-over-year; HIFU revenue up 51% year-over-year
  • Generated €41.7 million revenue and profitable operating result for the full year 2020.
  • Completed sales to renowned healthcare institutions, such as University of California, San Francisco Medical Center and Cleveland Clinic
  • Strong and increased cash position of EUR 24.7 million (USD 30.2 million) as of December 31, 2020
  • Company to host a conference call tomorrow, March 31, at 8:30 am ET

LYON, France, March 30, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the fourth quarter of 2020 and provided an update on strategic and operational developments. 

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “During the fourth quarter and full year 2020, we made great strides toward our mission of becoming a leader in the field of high intensity focused ultrasound. We delivered sequential revenue growth each quarter of the year notwithstanding the impact of the pandemic. We ended on a high note by delivering 28% year-over-year total revenue growth and 51% year-over-year HIFU revenue growth during the quarter, and in the process welcomed University of California, San Francisco Medical Center (UCSF) and Cleveland Clinic to our growing roster of highly regarded Focal One customers. This success was driven not only by the growing recognition of Focal One as a new treatment paradigm in the non-invasive ablation of cancerous prostate tissue, but also our strategic licensing agreement with Exact Imaging, and its lead product Exact Vu, which provides us with a comprehensive urology solution.

“Notably, we achieved all of this while delivering operating profitability for both the fourth quarter and full year and ended the year with an increased cash position of EUR 24.7 million. I believe we are well positioned to continue this momentum through 2021.”

Fourth Quarter 2020 Results

Total revenue for the fourth quarter 2020 was EUR 15.4 million (USD 18.3 million), an increase of 28.2% compared to total revenue of EUR 12.0 million (USD 13.3 million) for the same period in 2019.

Total revenue in the HIFU business for the fourth quarter 2020 was EUR 4.4 million (USD 5.2 million), a 50.8% increase compared to EUR 2.9 million (USD 3.2 million) for the fourth quarter of 2019.

Total revenue in the LITHO business for the fourth quarter 2020 was EUR 4.6 million (USD 5.5 million), a 10.6% increase compared to EUR 4.2 million (USD 4.6 million) for the fourth quarter of 2019.

Total revenue in the Distribution business for the fourth quarter 2020 was EUR 6.4 million (USD 7.6 million), a 29.7% increase compared to EUR 4.9 million (USD 5.5 million) for the fourth quarter of 2019.

Gross profit for the fourth quarter 2020 was EUR 7.0 million (USD 8.4 million), compared to EUR 5.1 million (USD 5.7 million) for the year-ago period. Gross profit margin on net sales was 45.8% in the fourth quarter of 2020, compared to 43.0% in the year-ago period. The increase in gross profit year-over-year was due to higher HIFU equipment sales.

Operating expenses were EUR 5.3 million (USD 6.3 million) for the fourth quarter of 2020, compared to EUR 5.1 million (USD 5.6 million) for the same period in 2019.

Operating profit for the fourth quarter of 2020 was EUR 1.7 million (USD 2.1 million), compared to an operating profit of EUR 0.08 million (USD 0.09 million) in the fourth quarter of 2019.

Net income for the fourth quarter of 2020 was EUR 0.8 million (USD 0.9 million), or EUR 0.03 per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.1 million), or EUR (0.03) per diluted share in the year-ago period.

Full Year 2020 Results

Total revenue for the full year 2020 was EUR 41.7 million (USD 47.8 million), a decrease of 7% compared to total revenue of EUR 44.9 million (USD 50.2 million) for the full year 2019. Full year revenue reflects the impact of the ongoing COVID-19 pandemic on the company’s activities.

Total revenue in the HIFU business for the full year 2020 was EUR 11.4 million (USD 13.1 million), a 19% decrease compared to EUR 14.1 million (USD 15.8 million) for the full year 2019.

Total revenue in the LITHO business for the full year 2020 was EUR 12.9 million (USD 14.8 million), a 9.2% decrease compared to 14.2 million (USD 15.9 million) for the full year 2019.

Total revenue in the Distribution business for the full year 2020 was EUR 17.3 million (USD 19.9 million), a 4.6% increase compared to EUR 16.6 million (USD 18.5 million) for the full year 2019.

Gross profit for the full year 2020 was EUR 18.4 million (USD 21.1 million), compared to EUR 21.0 million (USD 23.5 million) for the full year 2019. Gross profit margin on net sales was 44.1% for the full year 2020, compared to 46.8% in the prior year. The decline in gross profit year-over-year was due in part to lower sales in the HIFU business driven by COVID-19.

Operating expenses were EUR 18.1 million (USD 20.8 million) for the full year 2020, compared to EUR 18.8 million (USD 21.0 million) for the full year 2019.

Operating profit for the full year 2020 was EUR 0.3 million (USD 0.3 million), compared to an operating profit of EUR 2.2 million (USD 2.5 million) for the full year 2019.

Net loss for the full year 2020 was EUR 1.7 million (USD 2.0 million), or EUR (0.06) per diluted share, as compared to a net income of EUR 1.5 million (USD 1.7 million), or EUR 0.05 per diluted share in the prior year.

As of December 31, 2020, the Company recorded a strong cash position of EUR 24.7 million (USD 30.2 million).

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, March 31, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Wednesday, March 31, 2021 @ 8:30am Eastern Time
Domestic:                877-451-6152
International:                201-389-0879
Passcode:                13717550
Webcast:                http://public.viavid.com/index.php?id=143913

Following the live call, a replay will be available on the Company's website, www.edap-tms.com under "Investors Information."

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, and us.hifu-prostate.com.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements. 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 the length and severity of the COVID-19 pandemic, including its impacts across our businesses on demand for our devices and services. 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.

Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@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:
  Dec. 31,
2020
Euros
 

 
Dec. 31,
2019
Euros
  Dec. 31,
2020
$US
  Dec. 31,
2019
$US
   
Sales of medical equipment 11,439   7,972   13,661   8,876    
Net Sales of RPP and Leases 1,336   1,719   1,596   1,914    
Sales of spare parts, supplies and Services 2,587   2,259   3,089   2,515    
TOTAL NET SALES 15,363   11,950   18,346   13,305    
Other revenues 1   37   2   42    
TOTAL REVENUES 15,364   11,988   18,348   13,346    
Cost of sales (8,335)   (6,848)   (9,953)   (7,624)    
GROSS PROFIT 7,029   5,139   8,394   5,722    
Research & development expenses (1,439)   (844)   (1,718)   (939)    
S, G & A expenses (3,871)   (4,216)   (4,622)   (4,694)    
Total operating expenses (5,310)   (5,060)   (6,341)   (5,633)    
OPERATING PROFIT (LOSS) 1,720   79   2,053   88    
Interest (expense) income, net (46)   (43)   (55)   (48)    
Currency exchange gains (loss), net (728)   (652)   (869)   (726)    
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST 945   (616)   1,129   (685)    
Income tax (expense) credit (165)   (362)   (197)   (403)    
NET INCOME (LOSS)

 
780   (978)   932   (1,088)    
Earning per share – Basic 0.03   (0.03)   0.03   (0.04)    
Average number of shares used in computation of EPS 29,164,983   29,047,028   29,164,983   29,047,028    
Earning per share – Diluted 0.03   (0.03)   0.03   (0.04)    
Average number of shares used in computation of EPS for positive net income

 
30,222,258   29,047,028   30,222,258   29,047,028    

NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average three months’ noon buying rate of 1 Euro = 1.1942 USD, and 2019 average three months noon buying rate of 1 Euro = 1.1133 USD

EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of Euros and U.S. Dollars, except per share data)

  Twelve Months Ended:   Twelve Months Ended:
  Dec. 31,
2020
Euros
 

 
Dec. 31,
2019
Euros
  Dec. 31,
2020
$US
  Dec. 31,
2019
$US
   
Sales of medical equipment 27,523   30,111   31,581   { "@context": "https://schema.org", "@type": "FAQPage", "name": "EDAP Reports Fourth Quarter 2020 Results and Provides Operational Update FAQs", "mainEntity": [ { "@type": "Question", "name": "What were EDAP's Q4 2020 revenue figures?", "acceptedAnswer": { "@type": "Answer", "text": "EDAP reported Q4 2020 revenue of EUR 15.4 million (USD 18.3 million), a 28% increase year-over-year." } }, { "@type": "Question", "name": "How much did HIFU revenue increase in Q4 2020 for EDAP?", "acceptedAnswer": { "@type": "Answer", "text": "HIFU revenue for Q4 2020 increased by 51% compared to the same quarter in 2019." } }, { "@type": "Question", "name": "What was EDAP's cash position at the end of 2020?", "acceptedAnswer": { "@type": "Answer", "text": "As of December 31, 2020, EDAP had a strong cash position of EUR 24.7 million (USD 30.2 million)." } }, { "@type": "Question", "name": "What impact did COVID-19 have on EDAP's 2020 financial results?", "acceptedAnswer": { "@type": "Answer", "text": "COVID-19 led to a 7% decline in total revenue for EDAP in 2020, affecting HIFU and LITHO business revenues." } }, { "@type": "Question", "name": "When is EDAP's next conference call?", "acceptedAnswer": { "@type": "Answer", "text": "EDAP will host a conference call on March 31, 2021, at 8:30 am ET to review their financial results." } } ] }

FAQ

What were EDAP's Q4 2020 revenue figures?

EDAP reported Q4 2020 revenue of EUR 15.4 million (USD 18.3 million), a 28% increase year-over-year.

How much did HIFU revenue increase in Q4 2020 for EDAP?

HIFU revenue for Q4 2020 increased by 51% compared to the same quarter in 2019.

What was EDAP's cash position at the end of 2020?

As of December 31, 2020, EDAP had a strong cash position of EUR 24.7 million (USD 30.2 million).

What impact did COVID-19 have on EDAP's 2020 financial results?

COVID-19 led to a 7% decline in total revenue for EDAP in 2020, affecting HIFU and LITHO business revenues.

When is EDAP's next conference call?

EDAP will host a conference call on March 31, 2021, at 8:30 am ET to review their financial results.

EDAP TMS SA

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