• EDAP Reports Third Quarter 2021 Results and Provides Operational Update

    المصدر: Nasdaq GlobeNewswire / 17 نوفمبر 2021 16:35:00   America/New_York

    • Year-to-date revenue of approximately EUR 30.1 million (USD 35.9 million) increased 14.4% year-over-year
    • Q3 revenue of EUR 9.4 million (USD 11.1 million), flat with Q3 2020, reflecting lingering impact of COVID-19 on capital equipment sales
    • Year-to-date US HIFU treatment volumes increased 58% over the comparable period in 2020; strong leading indicator of Focal One adoption by urologists
    • Strong cash position of EUR 45.4 million (USD 52.6 million)
    • Company to host a conference call tomorrow, Thursday, November 18, at 8:30 am ET

    LYON, France, November 17, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the third quarter of 2021 and provided an update on strategic and operational developments. 

    Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “We are pleased with the continued strong growth in U.S. HIFU treatment volumes, which increased 58% year-to-date over the comparable period in 2020. This is a very positive sign as it reflects the growing adoption of focal therapy by urologists. Regarding our third quarter revenue, the COVID-19 pandemic continued to weigh on hospital capital spending, and this was further impacted by several machine placements that were delayed until the early days of the fourth quarter due to logistical challenges that were exacerbated by the resurgence of the pandemic in many parts of the world. Our leading indicators are strong, we are well financed, and I believe we are well positioned to exit the year with renewed momentum.”

    Nine Months 2021 Results

    Total revenue for the nine months ended September 30, 2021 was EUR 30.1 million (USD 35.9 million), an increase of 14.4% from total revenue of 26.3 million (USD 29.8 million) for the same period in 2020.

    Total revenue in the HIFU business for the nine months ended September 30, 2021 was EUR 5.7 million (USD 6.8 million), a decline of 18.9% as compared to EUR 7.1 million (USD 8.0 million) for the nine months ended September 30, 2020.

    Total revenue in the LITHO business for the nine months ended September 30, 2021 was EUR 7.7 million (USD 9.1 million), an decrease of 7.4% from EUR 8.3 million (USD 9.4 million) for the nine months ended September 30, 2020.

    Total revenue in the Distribution business for the nine months ended September 30, 2021 was EUR 16.7 million (USD 19.9 million), a 52.4% increase compared to EUR 11.0 million (USD 12.4 million) for the nine months ended September 30, 2020.

    Gross profit for the nine months ended September 30, 2021 was EUR 12.2 million (USD 14.6 million), compared to EUR 11.4 million (USD 12.8 million) for the year-ago period. Gross profit margin on net sales was 40.6% for the nine months ended September 30, 2021, compared to 43.2% for the comparable period in 2020. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

    Operating expenses were EUR 14.3 million (USD 17.0 million) for the nine months ended September 30, 2021, compared to EUR 12.8 million (USD 14.5 million) for the same period in 2020.

    Operating loss for the nine months ended September 30, 2021 was EUR 2.1 million (USD 2.5 million), compared to an operating loss of EUR 1.5 million (USD 1.6 million) for the nine months ended September 30, 2020.

    Net loss for the nine months ended September 30, 2021 was EUR 0.7 million (USD 0.8 million), or EUR (0.02) per diluted share, as compared to a net loss of EUR 2.5 million (USD 2.8 million), or EUR (0.09) per diluted share in the year-ago period.

    Third Quarter 2021 Results

    Total revenue for the third quarter 2021 was EUR 9.4 million (USD 11.1 million), roughly flat with total revenue of EUR 9.4 million (USD 11.2 million) for the same period in 2020.

    Total revenue in the HIFU business for the third quarter 2021 was EUR 1.9 million (USD 2.3 million), a decline of 25.6% as compared to EUR 2.6 million (USD 3.0 million) for the third quarter of 2020.

    Total revenue in the LITHO business for the third quarter 2021 was EUR 2.5 million (USD 2.9 million), an increase of 3.0% from EUR 2.4 million (USD 2.9 million) for the third quarter of 2020.

    Total revenue in the Distribution business for the third quarter 2021 was EUR 5.0 million (USD 5.9 million), a 13.4% increase compared to EUR 4.4 million (USD 5.2 million) for the third quarter of 2020.

    Gross profit for the third quarter 2021 was EUR 3.6 million (USD 4.3 million), compared to EUR 4.0 million (USD 4.7 million) for the year-ago period. Gross profit margin on net sales was 38.4% in the third quarter of 2021, compared to 42.0% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

    Operating expenses were EUR 5.5 million (USD 6.5 million) for the third quarter of 2021, compared to EUR 4.3 million (USD 5.0 million) for the same period in 2020.

    Operating loss for the third quarter of 2021 was EUR 1.9 million (USD 2.2 million), compared to an operating loss of EUR 0.3 million (USD 0.3 million) in the third quarter of 2020.

    Net loss for the third quarter of 2021 was EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share in the year-ago period.

    As of September 30, 2021, the company held cash and cash equivalents of EUR 45.4 million (USD $52.6 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

    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, November 18, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

    Conference Call & Webcast
    Thursday, November 18, 2021 @ 8:30am Eastern Time
    Domestic:                877-451-6152
    International:                201-389-0879
    Passcode:                13724088
    Webcast:                https://viavid.webcasts.com/starthere.jsp?ei=1503943&tp_key=7d846a9985

    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
    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:
      Sept. 30,
    2021
    Euros     		 

          		Sept. 30,
    2020
    Euros     		  Sept. 30,
    2021
    $US     		  Sept. 30,
    2020
    $US     		   
    Sales of medical equipment 5,788   5,984   6,799   7,080    
    Net Sales of RPP and Leases 1,104   1,207   1,297   1,428    
    Sales of spare parts, supplies and Services 2,548   2,255   2,993   2,668    
    TOTAL NET SALES 9,440   9,446   11,089   11,176    
    Other revenues -   (13)   -   (16)    
    TOTAL REVENUES 9,440   9,433   11,089   11,160    
    Cost of sales (5,815)   (5,469)   (6,831)   (6,470)    
    GROSS PROFIT 3,625   3,964   4,258   4,690    
    Research & development expenses (1,064)   (1,090)   (1,250)   (1,289)    
    S, G & A expenses (4,446)   (3,167)   (5,222)   (3,748)    
    Total operating expenses (5,510)   (4,257)   (6,472)   (5,037)    
    OPERATING PROFIT (LOSS) (1,885)   (293)   (2,215)   (347)    
    Interest (expense) income, net (22)   (12)   (25)   (14)    
    Currency exchange gains (loss), net 1,003   (574)   1,178   (679)    
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST (904)   (879)   (1,062)   (1,040)    
    Income tax (expense) credit (111)   (122)   (130)   (145)    
    NET INCOME (LOSS)

          		(1,015)   (1,001)   (1,192)   (1,185)    
    Earning per share – Basic (0.03)   (0.03)   (0.04)   (0.04)    
    Average number of shares used in computation of EPS 33,448,136   29,144,010   33,448,136   29,144,010    
    Earning per share – Diluted (0.03)   (0.03)   (0.04)   (0.04)    
    Average number of shares used in computation of EPS for positive net income

          		33,448,136   29,144,010   33,448,136   29,144,010    

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average three months’ noon buying rate of 1 Euro = 1.1747 USD, and 2020 average three months noon buying rate of 1 Euro = 1.1832 USD

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

      Nine Months Ended:   Nine Months Ended:
      Sept. 30,
    2021
    Euros     		 

          		Sept. 30,
    2020
    Euros     		  Sept. 30,
    2021
    $US     		  Sept. 30,
    2020
    $US     		   
    Sales of medical equipment 19,176   16,083   22,858   18,204    
    Net Sales of RPP and Leases 3,581   3,409   4,269   3,858    
    Sales of spare parts, supplies and Services 7,331   6,795   8,739   7,691    
    TOTAL NET SALES 30,088   26,287   35,866   29,753    
    Other revenues 4   11   5   12    
    TOTAL REVENUES 30,092   26,298   35,871   29,765    
    Cost of sales (17,881)   (14,948)   (21,315)   (16,919)    
    GROSS PROFIT 12,211   11,350   14,556   12,846    
    Research & development expenses (2,840)   (3,058)   (3,385)   (3,461)    
    S, G & A expenses (11,444)   (9,743)   (13,642)   (11,027)    
    Total operating expenses (14,284)   (12,800)   (17,027)   (14,488)    
    OPERATING PROFIT (LOSS) (2,073)   (1,451)   (2,471)   (1,642)    
    Interest (expense) income, net 122   (51)   145   (58)    
    Currency exchange gains (loss), net 1,574   (631)   1,876   (714)    
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST (378)   (2,133)   (450)   (2,415)    
    Income tax (expense) credit (288)   (351)   (343)   (397)    
    NET INCOME (LOSS)

          		(665)   (2,484)   (793)   (2,812)    
    Earning per share – Basic (0.02)   (0.09)   (0.02)   (0.10)    
    Average number of shares used in computation of EPS 32,881,747   29,142,788   32,881,747   29,142,788    
    Earning per share – Diluted (0.02)   (0.09)   (0.02)   (0.10)    
    Average number of shares used in computation of EPS for positive net income

          		32,881,747   29,142,788   32,881,747   29,142,788    

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average nine months’ noon buying rate of 1 Euro = 1.1920 USD, and 2020 average nine months noon buying rate of 1 Euro = 1.1319 USD 

    EDAP TMS S.A.
    UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS
    (Amounts in thousands of Euros and U.S. Dollars)

      September 30,
    2021
    Euros     		 

          		December 31,
    2020
    Euros     		  September 30,
    2021
    $US     		  December 31,
    2020
    $US
    Cash, cash equivalents and short-term treasury investments 45,411   24,696   52,572   30,201
    Account receivables, net 10,153   12,339   11,754   15,090
    Inventory 8,523   7,989   9,866   9,771
    Other current assets 585   369   677   451
    TOTAL CURRENT ASSETS 64,672   45,393   74,869   55,513
    Property, plant and equipment, net 4,927   5,599   5,704   6,847
    Goodwill 2,412   2,412   2,792   2,949
    Other non-current assets 1,675   1,790   1,939   2,189
    TOTAL ASSETS 73,686   55,193   85,304   67,498
    Accounts payable & other accrued liabilities 8,586   10,485   9,940   12,823
    Deferred revenues, current portion 3,538   2,701   4,096   3,304
    Short term borrowing 1,359   2,638   1,574   3,227
    Other current liabilities 1,428   5,679   1,653   6,945
    TOTAL CURRENT LIABILITIES 14,911   21,504   17,263   26,298
    Obligations under operating and finance leases non-current 1,287   1,653   1,490   2,022
    Long term debt, non-current 5,271   1,143   6,102   1,397
    Deferred revenues, non-current 698   926   808   1,132
    Other long term liabilities 3,478   3,720   4,026   4,549
    TOTAL LIABILITIES 25,646   28,945   29,689   35,399
    TOTAL SHAREHOLDERS’EQUITY 48,040   26,248   55,615   32,099
    TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY 73,686   55,193   85,304   67,498

    NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1577 USD, on September 30, 2021 and at the noon buying rate of 1 Euro = 1.2229 USD, on December 30, 2020.

    EDAP TMS S.A.
    UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (Amounts in thousands of Euros)

       

     

    9 months ended Sept. 30, 2021
    (Euros)     		   

     

    12 months ended Dec. 31, 2020
    (Euros)     		   

     

    9 months ended Sept. 30 2021
    ($US)     		   

     

    12 months ended Dec. 31, 2020
    ($US)
    NET INCOME (LOSS) (655)   (1,704)   (793)   (1,955)
    Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1) 2,553   3,790   3,043   4,349
    OPERATING CASH FLOW 1,888   2,087   2,250   2,394
    Increase/Decrease in operating assets and liabilities (113)   (110)   (135)   (126)
    NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES 1,774   1,977   2,115   2,269
    Additions to capitalized assets produced by the company and other capital expenditures (988)   (2,011)   (1,178)   (2,307)
    NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES (988)   (2,011)   (1,178)   (2,307)
    NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES 20,384   3,201   24,299   3,673
    NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS (455)   642   (2,865)   3,118
    NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 20,716   3,810   22,371   6,752

    (1) including share based compensation expenses for 1,154 thousand of Euros at the end of September 2021 and 160 thousand of Euros at the end of December 2020.

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average nine months’ noon buying rate of 1 Euro = 1.1920 USD, and 2020 average twelve months noon buying rate of 1 Euro = 1.1474USD 

    EDAP TMS S.A.
    UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
    NINE MONTHS ENDED SEPTEMBER 30, 2021
    (Amounts in thousands of Euros)

       

    HIFU
    Division     		   

    ESWL
    Division     		   

    Distribution
    Division     		   

    Reconciling
    Items     		   

    Total After Consolidation     		   
     

    Sales of goods     		 

    1,844     		   

    2,675     		   

    14,657     		       

    19,176     		   
    Sales of RPPs & Leases 2,617   767   197       3,581    
    Sales of spare parts & services 1,251   4,226   1,854       7,331    
    TOTAL NET SALES

          		5,713   7,667   16,708       30,088    
    Other revenues

          		4   0   0       4    
    TOTAL REVENUES 5,717   7,667   16,708       30,092    
    GROSS PROFIT
    (% of Total Revenues)     		2,150 37.6 % 3,526 46.0% 6,536 39.1%     12,211 40.6%
     

    Research & Development     		 

    (1,955)     		  (652)   (232)       (2,840)    
    Total SG&A plus depreciation (3,463)   (2,289)   (4,237)   (1,455)   (11,444)    
     

    OPERATING PROFIT (LOSS)     		 

    (3,269)     		   

    585     		   

    2,067     		   

    (1,455)     		   

    (2,073)     		   

     

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