• EDAP Reports Fourth Quarter and Full Year 2021 Results

    Источник: Nasdaq GlobeNewswire / 30 мар 2022 15:35:00   America/Chicago

    • Full year revenue of approximately EUR 44.1 million (USD 51.9 million) as compared to EUR 41.7 million (USD 47.8 million) for the full year 2020
    • Full year US HIFU treatment volumes increased 65% over full year 2020; Strong cash position of EUR 47.2M€ (USD 53.4M) as of December 31, 2021
    • Company to host a conference call tomorrow, Thursday, March 31, at 8:30 am ET

    LYON, France, March 30, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the fourth quarter and full year 2021.

    Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “We finished 2021 on a positive note, having reported several U.S. Focal OneTM installations at renowned academic and community hospitals while growing our pipeline opportunities to their highest level since receiving regulatory approval of Focal One in mid-2018. At the same time, US HIFU treatment volumes, our most important leading indicator, were up 65% for the full year, reflecting ongoing growth in adoption of focal therapy by urologists. We continued to make measured investments in our US team, and with growing support for focal therapy as a necessary part of any comprehensive prostate oncology program, we entered 2022 with a right-sized, world class organization capable of capturing this significant untapped opportunity with our state-of-the-art HIFU technology.”

    Full Year 2021 Results

    Total revenue for the full year 2021 was EUR 44.1 million (USD 51.9 million), an increase of 5.8% from total revenue of 41.7 million (USD 47.8 million) for the full year 2020.

    Total revenue in the HIFU business for the full year 2021 were EUR 9.9 million (USD 11.7 million), as compared to EUR 11.4 million (USD 13.1 million) for the full year 2020.

    Total revenue in the LITHO business for the full year 2021 was EUR 11.0 million (USD 13.0 million), as compared to EUR 12.9 million (USD 14.8 million) for the full year 2020.

    Total revenue in the Distribution business for the full year 2021 was EUR 23.1 million (USD 27.3 million), as compared to EUR 17.3 million (USD 19.9 million) for the full year 2020.

    Gross profit for the full year 2021 was EUR 18.4 million (USD 21.7 million), compared to EUR 18.4 million (USD 21.1 million) for the full year 2020. Gross profit margin on net sales was 41.8 % for the full year 2021, compared to 44.1% for the comparable period in 2020.

    Operating expenses were EUR 20.0 million (USD 23.6 million) for the full year 2021 as compared to EUR 18.1 million (USD 20.8 million) for the full year 2020.

    Operating loss for the full year 2021 was EUR 1.6 million (USD 1.9 million), compared to an operating profit of EUR 0.3 million (USD 0.3 million) for the full year 2020.

    Net income for the full year 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 1.7 million (USD 2.0 million), or EUR 0.06 per diluted share for the full year 2020.

    Fourth Quarter 2021 Results

    Total revenue for the fourth quarter 2021 was EUR 14.0 million (USD 15.9 million), as compared to total revenue of EUR 15.4 million (USD 18.3 million) for the same period in 2020.

    Total revenue in the HIFU business for the fourth quarter 2021 was EUR 4.2 million (USD 4.8 million), as compared to EUR 4.4 million (USD 5.2 million) for the fourth quarter of 2020.

    Total revenue in the LITHO business for the fourth quarter 2021 was EUR 3.3 million (USD 3.8 million), as compared to EUR 4.6 million (USD 5.5 million) for the fourth quarter of 2020.

    Total revenue in the Distribution business for the fourth quarter 2021 was EUR 6.4 million (USD 7.3 million), as compared to EUR 6.4 million (USD 7.6 million) for the fourth quarter of 2020.

    Gross profit for the fourth quarter 2021 was EUR 6.2 million (USD 7.1 million), compared to EUR 7.0 million (USD 8.4 million) for the year-ago period. Gross profit margin on net sales was 44.5 % in the fourth quarter of 2021, compared to 45.8% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs.

    Operating expenses were EUR 5.8 million (USD 6.5 million) for the fourth quarter of 2021, compared to EUR 5.3 million (USD 6.3 million) for the same period in 2020.

    Operating profit for the fourth quarter of 2021 was EUR 0.5 million (USD 0.5 million), compared to an operating profit of EUR 1.7 million (USD 2.1 million) in the fourth quarter of 2020.

    Net income for the fourth quarter of 2021 was EUR 1.4 million (USD 1.6 million), or EUR 0.04 per diluted share, as compared to net income of EUR 0.8 million (USD 0.9 million), or EUR 0.03 per diluted share in the year-ago period.

    As of December 31, 2021, the company held cash and cash equivalents of EUR 47.2M (USD 53.4M) 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, March 31, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

    Conference Call & Webcast
    Thursday, March 31, 2022 @ 8:30am Eastern Time
    Domestic:                877-451-6152
    International:                201-389-0879
    Passcode:                13727107
    Webcast:                https://viavid.webcasts.com/starthere.jsp?ei=1529371&tp_key=b54f335485

    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:
      Dec. 31,
    2021
    Euros     		 

          		Dec. 31,
    2020
    Euros     		  Dec. 31,
    2021
    $US     		  Dec. 31,
    2020
    $US     		   
    Sales of medical equipment 9,864   11,439   11,231   13,661    
    Net Sales of RPP and Leases 1,387   1,336   1,579   1,596    
    Sales of spare parts, supplies and Services 2,720   2,587   3,097   3,089    
    TOTAL NET SALES 13,971   15,363   15,907   18,346    
    Other revenues 1   1   2   2    
    TOTAL REVENUES 13,973   15,364   15,909   18,348    
    Cost of sales (7,762)   (8,335)   (8,837)   (9,953)    
    GROSS PROFIT 6,211   7,029   7,072   8,394    
    Research & development expenses (562)   (1,439)   (640)   (1,718)    
    S, G & A expenses (5,188)   (3,871)   (5,907)   (4,622)    
    Total operating expenses (5,750)   (5,310)   (6,547)   (6,341)    
    OPERATING PROFIT (LOSS) 461   1,720   525   2,053    
    Interest (expense) income, net 23   (46)   26   (55)    
    Currency exchange gains (loss), net 786   (728)   895   (869)    
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST 1,270   945   1,446   1,129    
    Income tax (expense) credit 95   (165)   108   (197)    
    NET INCOME (LOSS)

          		1,365   780   1,554   932    
    Earning per share – Basic 0.04   0.03   0.05   0.03    
    Average number of shares used in computation of EPS 33,466,136   29,164,983   33,466,136   29,164,983    
    Earning per share – Diluted 0.04   0.03   0.04   0.03    
    Average number of shares used in computation of EPS for positive net income

          		34,555,716   30,222,258   33,555,716   30,222,258    

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average three months’ noon buying rate of 1 Euro = 1.1386 USD, and 2020 average three months noon buying rate of 1 Euro = 1.1942 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,
    2021
    Euros     		 

          		Dec. 31,
    2020
    Euros     		  Dec. 31,
    2021
    $US     		  Dec. 31,
    2020
    $US     		   
    Sales of medical equipment 29,040   27,523   34,229   31,581    
    Net Sales of RPP and Leases 4,968   4,745   5,856   5,445    
    Sales of spare parts, supplies and Services 10,052   9,382   11,848   10,765    
    TOTAL NET SALES 44,060   41,649   51,932   47,791    
    Other revenues 6   12   7   14    
    TOTAL REVENUES 44,065   41,662   51,939   47,805    
    Cost of sales (25,643)   (23,283)   (30,225)   (26,716)    
    GROSS PROFIT 18,422   18,379   21,714   21,089    
    Research & development expenses (3,402)   (4,496)   (4,010)   (5,159)    
    S, G & A expenses (16,633)   (13,614)   (19,605)   (15,621)    
    Total operating expenses (20,034)   (18,110)   (23,614)   (20,780)    
    OPERATING PROFIT (LOSS) (1,612)   269   (1,900)   309    
    Interest (expense) income, net 145   (98)   171   (112)    
    Currency exchange gains (loss), net 2,360   (1,359)   2,781   (1,559)    
    Other income, net -   -   -   (1)    
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST 893   (1,188)   1,052   (1,363)    
    Income tax (expense) credit (193)   (516)   (227)   (592)    
    NET INCOME (LOSS)

          		700   (1,704)   825   (1,955)    
    Earning per share – Basic 0.02   (0.06)   0.02   (0.07)    
    Average number of shares used in computation of EPS 33,457,469   29,148,108   33,457,469   29,148,108    
    Earning per share – Diluted 0.02   (0.06)   0.02   (0.07)    
    Average number of shares used in computation of EPS for positive net income

          		35,843,019   29,148,108   35,843,019   29,148,108    

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average twelve months’ noon buying rate of 1 Euro = 1.1787 USD, and 2020 average twelve months noon buying rate of 1 Euro = 1.1474 USD 

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

      Dec. 31,
    2021
    Euros     		 

          		Dec. 31,
    2020
    Euros     		  Dec. 31,
    2021
    $US     		  Dec. 31,
    2020
    $US
    Cash, cash equivalents and short-term treasury investments 47,183   24,696   53,405   30,201
    Account receivables, net 12,118   12,339   13,716   15,090
    Inventory 7,499   7,989   8,487   9,771
    Other current assets 581   369   658   451
    TOTAL CURRENT ASSETS 67,382   45,393   76,267   55,513
    Property, plant and equipment, net 5,173   5,599   5,855   6,847
    Goodwill 2,412   2,412   2,730   2,949
    Other non-current assets 2,260   1,790   2,558   2,189
    TOTAL ASSETS 77,226   55,193   87,409   67,498
    Accounts payable & other accrued liabilities 10,786   10,485   12,208   12,823
    Deferred revenues, current portion 3,408   2,701   3,857   3,304
    Short term borrowing 1,914   2,638   2,167   3,227
    Other current liabilities 1,843   5,679   2,086   6,945
    TOTAL CURRENT LIABILITIES 17,951   21,504   20,318   26,298
    Obligations under operating and finance leases non-current 1,318   1,653   1,492   2,022
    Long term debt, non-current 4,930   1,143   5,580   1,397
    Deferred revenues, non-current 440   926   498   1,132
    Other long term liabilities 2,534   3,720   2,868   4,549
    TOTAL LIABILITIES 27,172   28,945   30,755   35,399
    TOTAL SHAREHOLDERS’EQUITY 50,054   26,248   56,655   32,099
    TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY 77,226   55,193   87,409   67,498

    NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1319 USD on December 31, 2021 and at the noon buying rate of 1 Euro = 1.2229 USD, on December 31, 2020

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

      Dec. 31, 2021
    Euros     		  Dec. 31, 2020
    Euros     		  Dec. 31, 2021
    $US     		  Dec. 31, 2020
    $US
    NET INCOME (LOSS) 700   (1,704)   825   (1,955)
    Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1) 3,225   3,790   3,801   4,349
    OPERATING CASH FLOW 3,925   2,087   4,626   2,394
    Increase/Decrease in operating assets and liabilities 520   (110)   613   (126)
    NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES 4,445   1,977   5,239   2,269
    Short term investments(2) -   -   -   -
    Additions to capitalized assets produced by the company and other capital expenditures (1,638)   (2,011)   (1,931)   (2,307)
    NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES (1,638)   (2,011)   (1,931)   (2,307)
    NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES 20,266   3,201   23,887   3,673
    NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS (585)   642   (3,992)   3,118
    NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 22,488   3,810   23,204   6,752

    (1) including Share based compensation expenses for 1,900 thousand of Euros at the end of December 2021, and 160 thousand of Euros at the end of December 2020

    (2) Short term investments are comprised of money market funds

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average twelve months’ noon buying rate of 1 Euro = 1.1787 USD and 2020 average twelve months’ noon buying rate of 1 Euro = 1.1474 USD.

    EDAP TMS S.A.
    UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
    TWELVE MONTHS ENDED DECEMBER 31, 2021
    (Amounts in thousands of Euros)

       

    HIFU
    Division     		   

    ESWL
    Division     		   

    Distribution
    Division     		   

    Reconciling
    Items     		   

    Total After Consolidation     		   
     

    Sales of goods     		 

    4,515     		   

    4,236     		   

    20,289     		       

    29,040     		   
    Sales of RPPs & Leases 3,679   1,022   267       4,968    
    Sales of spare parts & services 1,715   5,758   2,578       10,052    
    TOTAL NET SALES

          		9,910   11,016   23,134       44,060    
    Other revenues

          		6   0   0       6    
    TOTAL REVENUES 9,915   11,016   23,134       44,065    
    GROSS PROFIT
    (% of Total Revenues)     		4,604 46.4% 4,936 44.8% 8,882 38.4%     18,422 41.8%
     

    Research & Development     		 

    (2,238)     		  (835)   (329)       (3,402)    
    Total SG&A plus depreciation (5,391)   (3,208)   (6,129)   (1,904)   (16,633)    
     

    OPERATING PROFIT (LOSS)     		 

    (3,025)     		   

    893     		   

    2,424     		   

    (1,904)     		   

    (1,612)     		   

     

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