• EDAP Reports First Quarter 2022 Results

    المصدر: Nasdaq GlobeNewswire / 17 مايو 2022 16:35:00   America/New_York

    • First quarter 2022 revenue of approximately EUR 13.0 million (USD 14.5 million), an increase of 26% as compared to EUR 10.3 million (USD 12.4 million) for the first quarter 2021
    • Four Focal One units sold in Q1 2022 versus zero in Q1 2021
    • Strong cash position of $51.6 million as of March 31, 2022
    • Company to host a conference call tomorrow, Wednesday, May 18, at 8:30 am ET

    LYON, France, May 17, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the first quarter 2022.

    Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “As we announced in our business update press release just a few weeks ago, the first quarter was one in which the positive impact of our new U.S. organization, led by CEO Ryan Rhodes, was featured prominently. We ended 2021 on a strong note and continued that momentum into Q1 by adding three more highly regarded U.S. academic medical centers to our client roster, including New York-Presbyterian/Weill Cornell Medical Center, Beth Israel Deaconess Lahey Health, an affiliate of Harvard Medical School, and University of California Davis Medical Center in Sacramento. We also sold a Focal One outside of the U.S.

    “Combined with another strong quarter from our distribution business, we grew revenue 26% year-over-year in the first quarter. We have a very rich pipeline of US prospects – both academic medical centers and community hospitals – and I am confident that we will continue to convert these to Focal One reference sites this year as acceptance of focal therapy as a treatment option within the urology suite continues to gain acceptance.”

    Ryan Rhodes, Chief Executive Officer of EDAP US, stated, “2022 represents the first year in which we entered the year with a right-sized U.S. organization capable of capturing the significant untapped opportunity at a time when more and more urologists are recognizing the value of HIFU along the prostate cancer care continuum. The interest in our technology that we saw at last week’s American Urology Association meeting confirms that we are in the right place at the right time, with a cutting-edge platform that can truly make a positive difference in the lives of prostate cancer patients. I believe we are set up for a successful year even while we continue to make measured investments in our U.S. infrastructure.”    

    First Quarter 2022 Results

    Total revenue for the first quarter 2022 was EUR 13.0 million (USD 14.5 million), an increase of 26% as compared to total revenue of EUR 10.3 million (USD 12.4 million) for the same period in 2021.

    Total revenue in the HIFU business for the first quarter 2022 was EUR 3.8 million (USD 4.3 million), as compared to EUR 1.8 million (USD 2.2 million) for the first quarter of 2021. The increase was driven by four Focal One units sold in the first quarter 2022 versus zero units sold in the first quarter 2021.

    Total revenue in the LITHO business for the first quarter 2022 was EUR 2.2 million (USD 2.5 million), as compared to EUR 2.9 million (USD 3.5 million) for the first quarter of 2021. The decline was driven by one lithotripsy unit sold in the first quarter of 2022 as compared to six units sold in the first quarter of 2021.

    Total revenue in the Distribution business for the first quarter 2022 was EUR 7.0 million (USD 7.8 million), as compared to EUR 5.6 million (USD 6.7 million) for the first quarter of 2021. The increase was driven primarily by nine ExactVu units sold during the first quarter of 2022 as compared to five units sold during the first quarter of 2021.

    Gross profit for the first quarter 2022 was EUR 5.8 million (USD 6.4 million), compared to EUR 4.4 million (USD 5.2 million) for the year-ago period. Gross profit margin on net sales was 44.3 % in the first quarter of 2022, compared to 42.4% in the year-ago period.

    Operating expenses were EUR 5.9 million (USD 6.6 million) for the first quarter of 2022, compared to EUR 4.1 million (USD 5.0 million) for the same period in 2021.

    Operating loss for the first quarter of 2022 was EUR 0.1 million (USD 0.1 million), compared to an operating profit of EUR 0.2 million (USD 0.3 million) in the first quarter of 2021.

    Net income for the first quarter of 2022 was EUR 0.4 million (USD 0.4 million), or EUR 0.01 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 March 31, 2022, the company held cash and cash equivalents of EUR 46.5 million (USD 51.6 million) as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

    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, May 18, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

    Conference Call & Webcast
    Wednesday, May 18, 2022 @ 8:30am Eastern Time
    Domestic:                877-451-6152
    International:            201-389-0879
    Passcode:                13728747
    Webcast:                https://viavid.webcasts.com/starthere.jsp?ei=1541898&tp_key=e83b07e195

    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 focalone.com, 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:
      Mar. 31,
    2022
    Euros     		 

          		Mar. 31,
    2021
    Euros     		  Mar. 31,
    2022
    $US     		  Mar. 31,
    2021
    $US     		   
    Sales of medical equipment 8,966   6,691   10,021   8,023    
    Net Sales of RPP and Leases 1,317   1,212   1,472   1,453    
    Sales of spare parts, supplies and Services 2,715   2,396   3,035   2,873    
    TOTAL NET SALES 12,998   10,299   14,527   12,349    
    Other revenues 0   3   0   3    
    TOTAL REVENUES 12,998   10,302   14,527   12,353    
    Cost of sales (7,241)   (5,932)   (8,093)   (7,112)    
    GROSS PROFIT 5,757   4,371   6,434   5,241    
    Research & development expenses (1,081)   (851)   (1,208)   (1,020)    
    S, G & A expenses (4,787)   (3,281)   (5,351)   (3,934)    
    Total operating expenses (5,868)   (4,132)   (6,559)   (4,954)    
    OPERATING PROFIT (LOSS) (111)   239   (125)   287    
    Interest (expense) income, net (29)   164   (32)   196    
    Currency exchange gains (loss), net 569   489   636   587    
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST 429   892   480   1,070    
    Income tax (expense) credit (72)   (119)   (81)   (143)    
    NET INCOME (LOSS)

          		357   773   399   927    
    Earning per share – Basic 0.01   0.03   0.01   0.03    
    Average number of shares used in computation of EPS 33,466,136   29,189,955   33,466,136   29,189,955    
    Earning per share – Diluted 0.01   0.03   0.01   0.03    
    Average number of shares used in computation of EPS for positive net income

          		34,031,361   30,352,216   34,031,361   30,352,216    

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average three months’ noon buying rate of 1 Euro = 1.1177 USD, and 2021 average three months noon buying rate of 1 Euro = 1.1990 USD 

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

      Mar. 31,
    2022
    Euros     		 

          		Dec. 31,
    2021
    Euros     		  Mar. 31,
    2022
    $US     		  Dec. 31,
    2021
    $US
    Cash, cash equivalents and short-term treasury investments 46,498   47,183   51,579   53,405
    Account receivables, net 11,953   12,118   13,259   13,716
    Inventory 7,342   7,499   8,144   8,487
    Other current assets 771   581   855   658
    TOTAL CURRENT ASSETS 66,565   67,382   78,838   76,267
    Property, plant and equipment, net 5,251   5,173   5,825   5,855
    Goodwill 2,412   2,412   2,675   2,730
    Other non-current assets 2,221   2,260   2,464   2,558
    TOTAL ASSETS 76,448   77,226   84,801   87,409
    Accounts payable & other accrued liabilities 9,881   10,786   10,961   12,208
    Deferred revenues, current portion 3,501   3,408   3,884   3,857
    Short term borrowing 857   1,914   950   2,167
    Other current liabilities 1,977   1,843   2,193   2,086
    TOTAL CURRENT LIABILITIES 16,216   17,951   17,988   20,318
    Obligations under operating and finance leases non-current 1,159   1,318   1,286   1,492
    Long term debt, non-current 4,952   4,930   5,482   5,580
    Deferred revenues, non-current 338   440   375   498
    Other long term liabilities 3,031   2,534   3,363   2,868
    TOTAL LIABILITIES 25,688   27,172   28,494   30,755
    TOTAL SHAREHOLDERS’EQUITY 50,761   50,054   56,307   56,655
    TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY 76,448   77,226   84,801   87,409

    NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1093 USD on March 31, 2022 and at the noon buying rate of 1 Euro = 1.1319 USD, on December 31, 2021

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

      3-months ended
    Mar. 31, 2022
    Euros     		  12-months ended
    Dec. 31, 2021
    Euros     		  3-months ended Mar. 31, 2022
    $US     		  12-months ended
    Dec. 31 2021
    $US
    NET INCOME (LOSS) 360   700   402   825
    Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1) 1,127   3,225   1,259   3,801
    OPERATING CASH FLOW 1,487   3,925   1,662   4,626
    Increase/Decrease in operating assets and liabilities (399)   520   (446)   613
    NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES 1,087   4,445   1,215   5,239
    Short term investments(2) -   -   -   -
    Additions to capitalized assets produced by the company and other capital expenditures (692)   (1,638)   (774)   (1,931)
    NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES (692)   (1,638)   (774)   (1,931)
    NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES (943)   20,266   (1,054)   23,887
    NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS (137)   (585)   (1,213)   (3,992)
    NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (685)   22,488   (1,826)   23,204

    (1) including Share based compensation expenses for 583 thousand of Euros at the end of March 2022, and 1,9 million of Euros at the end of December 2021
    (2) Short term investments are comprised of money market funds

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average three months’ noon buying rate of 1 Euro = 1.1177 USD and at the 2021 average twelve months’ noon buying rate of 1 Euro = 1.1787 USD

    EDAP TMS S.A.
    UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
    THREE MONTHS ENDED MARCH 31, 2022
    (Amounts in thousands of Euros)

       

    HIFU
    Division     		   

    ESWL
    Division     		   

    Distribution
    Division     		   

    Reconciling
    Items     		   

    Total After Consolidation     		   
     

    Sales of goods     		 

    2,406     		   

    510     		   

    6,049     		       

    8,966     		   
    Sales of RPPs & Leases 965   284   68       1,317    
    Sales of spare parts & services 446   1,431   838       2,715    
    TOTAL NET SALES

          		3,817   2,225   6,955       12,998    
    Other revenues

          		0   0   0       0    
    TOTAL REVENUES 3,817   2,225   6,955       12,998    
    GROSS PROFIT
    (% of Total Revenues)     		2,030 53.2 % 973 43.7% 2,754 39.6%     5,757 44.3%
     

    Research & Development     		 

    (729)     		  (243)   (109)       (1,081)    
    Total SG&A plus depreciation (1,716)   (701)   (1,803)   (567)   (4,787)    
     

    OPERATING PROFIT (LOSS)     		 

    (415)     		   

    29     		   

    842     		   

    (567)     		   

    (111)     		   

     

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