• EDAP Reports Third Quarter 2022 Results

    ソース: Nasdaq GlobeNewswire / 16 11 2022 15:35:00   America/Chicago

    • Generated Q3 2022 total revenue of approximately EUR 12.2 million (USD 12.3 million), an increase of 29.7 % as compared to EUR 9.4 million (USD 11.1 million) for Q3 2021; nine-month year-to-date revenue increased 30.9% compared to the same period in 2021
    • Generated HIFU sales of EUR $3.5 million (USD 3.5 million), representing growth of 81% over EUR 1.9 million (USD 2.3 million) for Q3 2021
    • Reimbursement increase finalized: U.S. Centers for Medicare and Medicaid Services (CMS), in its final Outpatient Prospective Payment System (OPPS) rule for CY23, increased reimbursement for HIFU prostate ablation from APC Level 5 to Level 6 which increases hospital reimbursement by more than 90%
    • Exited the quarter with a strong cash position of EUR 68.3 million (USD 66.8 million) as of September 30, 2022
    • Conference call and webcast scheduled for tomorrow, Thursday, November 17, at 8:30 am ET

    LYON, France, November 16, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the third quarter 2022.

    Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “For the third quarter 2022, we generated robust year-over-year revenue growth of nearly 30%, driven by continued strength in our HIFU business, which contributed revenue growth of 81% over the prior year period. This was a record calendar third quarter for our company. Clearly, our recent efforts to bolster our U.S. commercial presence are having a significant positive impact, and I believe we are well positioned to complete the year with significant momentum.”

    Ryan Rhodes, Chief Executive Officer of EDAP US, stated, “We successfully executed in the third quarter to drive adoption of Focal One HIFU as the leading non-invasive focal therapy platform. Three new hospitals purchased Focal One systems in the quarter, and we continue to see increased adoption of Focal One amongst our growing installed base. We believe the increase in 2023 reimbursement for HIFU ablation will significantly improve access in the number of facilities that choose to invest in Focal One Robotic HIFU as part of a comprehensive approach to the management of prostate cancer.”

    Year-to-Date Results

    Total revenue for the nine months ended September 30, 2022, was EUR 39.4 million (USD 41.7 million), an increase of 30.9% from total revenue of was EUR 30.1 million (USD 35.9 million) for the same period in 2021.

    Total revenue in the HIFU business for the nine months ended September 30, 2022, was EUR 10.3 million (USD 10.9 million), an increase of 79.7% as compared to EUR 5.7 million (USD 6.8 million) for the nine months ended September 30, 2021.

    Total revenue in the LITHO business for the nine months ended September 30, 2022, was EUR 8.0 million (USD 8.4 million), an increase of 3.9% from EUR 7.7 million (USD 9.1 million) for the nine months ended September 30, 2021.

    Total revenue in the Distribution business for the nine months ended September 30, 2022, was EUR 21.2 million (USD 22.4 million), a 26.6% increase compared to EUR 16.7 million (USD 19.9 million) for the nine months ended September 30, 2021.

    Gross profit for the nine months ended September 30, 2022, was EUR 17.0 million (USD 18.0 million), compared to EUR 12.2 million (USD 14.6 million) for the year-ago period. Gross profit margin on net sales was 43.1% for the nine months ended September 30, 2022, compared to 40.6% for the comparable period in 2021. The increase in gross profit year-over-year was due to higher sales effect on fixed costs, particularly in the HIFU business.

    Operating expenses were EUR 19.7 million (USD 20.8 million) for the nine months ended September 30, 2022, compared to EUR 14.3 million (USD 17.0 million) for the same period in 2021.

    Operating loss for the nine months ended September 30, 2022, was EUR 2.7 million (USD 2.8 million), compared to an operating loss of EUR 2.1 million (USD 2.5 million) for the nine months ended September 30, 2021.

    Net income for the nine months ended September 30, 2022, was EUR 2.2 million (USD 2.3 million), or EUR 0.07 per diluted share, as compared to a net loss of EUR 0.7 million (USD 0.8 million), or EUR (0.02) per diluted share in the year-ago period.

    As of September 30, 2022, the company held cash, cash equivalents and short term investments of EUR 68.3 million (USD 66.8 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

    Third Quarter 2022 Results

    Total revenue for the third quarter 2022 was EUR 12.2 million (USD 12.3 million), a 29.7% increase as compared to total revenue of EUR 9.4 million (USD 11.1 million) for the same period in 2021.

    Total revenue in the HIFU business for the third quarter 2022 was EUR 3.5 million (USD 3.5 million), an increase of 80.9% as compared to EUR 1.9 million (USD 2.3 million) for the third quarter of 2021.

    Total revenue in the LITHO business for the third quarter 2022 was EUR 2.2 million (USD 2.2 million), a decrease of 12.1% from was EUR 2.5 million (USD 2.9 million) for the third quarter of 2021.

    Total revenue in the Distribution business for the third quarter 2022 was EUR 6.6 million (USD 6.6 million), a 30.9% increase compared to EUR 5.0 million (USD 5.9 million) for the third quarter of 2021.

    Gross profit for the third quarter 2022 was EUR 5.0 million (USD 5.0 million), compared to EUR 3.6 million (USD 4.2 million) for the year-ago period. Gross profit margin on net sales was 41.0% in the third quarter of 2022, compared to 38.4% in the year-ago period. The increase in gross profit year-over-year was driven by the higher sales effect on fixed costs.

    Operating expenses were EUR 7.2 million (USD 7.2 million) for the third quarter of 2022, compared to EUR 5.5 million (USD 6.5 million) for the same period in 2021.

    Operating loss for the third quarter of 2022 was EUR 2.1 million (USD 2.2 million), compared to an operating loss of EUR 1.9 million (USD 2.2 million) in the third quarter of 2021.

    Net income for the third quarter of 2022 was EUR 0.0 million (USD 0.0 million), or EUR 0.00 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.

    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 17, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

    Conference Call & Webcast
    Thursday, November 17, 2022 @ 8:30am Eastern Time
    Domestic:                877-451-6152
    International:            201-389-0879
    Passcode:                13733576
    Webcast link:            Here

    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 and www.focalone.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:
           September 30,       September 30,       September 30,       September 30, 
        2022   2021   2022   2021
        Euros   Euros   $US   $US
    Sales of medical equipment   8,319   5,788   8,333   6,799
    Net Sales of RPP and Leases   1,214   1,104   1,216   1,297
    Sales of spare parts, supplies and Services   2,710   2,548   2,714   2,993
    TOTAL NET SALES   12,243   9,440   12,263   11,089
    Other revenues   —   —   —   —
    TOTAL REVENUES   12,243   9,440   12,263   11,089
    Cost of sales   (7,226)   (5,815)   (7,238)   (6,831)
    GROSS PROFIT   5,017   3,625   5,026   4,258
    Research & development expenses   (1,361)   (1,064)   (1,363)   (1,250)
    S, G & A expenses   (5,805)   (4,446)   (5,815)   (5,222)
    Total operating expenses   (7,165)   (5,510)   (7,178)   (6,472)
    OPERATING PROFIT (LOSS)   (2,148)   (1,885)   (2,152)   (2,215)
    Interest (expense) income, net   (4)   (22)   (4)   (25)
    Currency exchange gains (loss), net   3,020   1,003   3,025   1,178
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST   867   (904)   869   (1,062)
    Income tax (expense) credit   (854)   (111)   (856)   (130)
    NET INCOME (LOSS)   13   (1,015)   13   (1,192)
    Earning per share – Basic   0.00   (0.03)   0.00   (0.04)
    Average number of shares used in computation of EPS   33,696,543   33,448,136   33,696,543   33,448,136
    Earning per share – Diluted   0.00   (0.03)   0.00   (0.04)
    Average number of shares used in computation of EPS for positive net income   34,612,773   33,448,136   34,612,773   33,448,136

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average three months’ noon buying rate of 1 Euro = 1.0017 USD, and 2021 average three months noon buying rate of 1 Euro = 1.1747 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:
           September 30,       September 30,       September 30,       September 30, 
        2022   2021   2022   2021
        Euros   Euros   $US   $US
    Sales of medical equipment   26,969   19,176   28,563   22,858
    Net Sales of RPP and Leases   4,176   3,581   4,423   4,269
    Sales of spare parts, supplies and Services   8,245   7,331   8,733   8,739
    TOTAL NET SALES   39,391   30,088   41,719   35,866
    Other revenues   —   4   —   5
    TOTAL REVENUES   39,391   30,092   41,719   35,871
    Cost of sales   (22,416)   (17,881)   (23,741)   (21,315)
    GROSS PROFIT   16,975   12,211   17,978   14,556
    Research & development expenses   (3,615)   (2,840)   (3,829)   (3,385)
    S, G & A expenses   (16,047)   (11,444)   (16,995)   (13,642)
    Total operating expenses   (19,662)   (14,284)   (20,824)   (17,027)
    OPERATING PROFIT (LOSS)   (2,687)   (2,073)   (2,846)   (2,471)
    Interest (expense) income, net   (62)   122   (66)   145
    Currency exchange gains (loss), net   6,001   1,574   6,355   1,876
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST   3,251   (378)   3,443   (450)
    Income tax (expense) credit   (1,054)   (288)   (1,117)   (343)
    NET INCOME (LOSS)   2,197   (665)   2,327   (793)
    Earning per share – Basic   0.07   (0.02)   0.07   (0.02)
    Average number of shares used in computation of EPS   33,544,003   32,881,747   33,544,003   32,881,747
    Earning per share – Diluted   0.06   (0.02)   0.07   (0.02)
    Average number of shares used in computation of EPS for positive net income   34,301,115   32,881,747   34,301,115   32,881,747

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average nine months’ noon buying rate of 1 Euro = 1.0591 USD, and 2021 average nine months noon buying rate of 1 Euro = 1.1920 USD

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

                     
           September 30,       December 31,       September 30,       December 31, 
        2022   2021   2022   2021
        Euros   Euros   $US   $US
    Cash, cash equivalents and short-term treasury investments   68,329   47,183   66,845   53,405
    Account receivables, net   15,131   12,118   14,802   13,716
    Inventory   9,561   7,499   9,353   8,487
    Other current assets   1,007   581   985   658
    TOTAL CURRENT ASSETS   94,027   67,382   91,985   76,267
    Property, plant and equipment, net   6,133   5,173   6,000   5,855
    Goodwill   2,412   2,412   2,359   2,730
    Other non-current assets   2,230   2,260   2,181   2,558
    TOTAL ASSETS   104,801   77,226   102,525   87,409
    Accounts payable & other accrued liabilities   13,366   10,786   13,076   12,208
    Deferred revenues, current portion   4,230   3,408   4,138   3,857
    Short term borrowing   1,237   1,914   1,210   2,167
    Other current liabilities   2,688   1,843   2,629   2,086
    TOTAL CURRENT LIABILITIES   21,521   17,951   21,053   20,318
    Obligations under operating and finance leases non-current   1,583   1,318   1,548   1,492
    Long term debt, non-current   4,021   4,930   3,934   5,580
    Deferred revenues, non-current   331   440   324   498
    Other long term liabilities   3,104   2,534   3,037   2,868
    TOTAL LIABILITIES   30,560   27,172   29,896   30,755
    TOTAL SHAREHOLDERS’EQUITY   74,242   50,054   72,629   56,655
    TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY   104,801   77,226   102,525   87,409

    NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 0.9783 USD, on September 30, 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)

                     
           Nine Months Ended      Twelve Months Ended      Nine Months Ended      Twelve Months Ended
        September 30,    December 31,    September 30,    December 31, 
        2022   2021   2022   2021
        (Euros)   (Euros)   ($US)   ($US)
    NET INCOME (LOSS)   2,197   700   2,327   825
    Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)   2,931   3,225   3,104   3,801
    OPERATING CASH FLOW   5,128   3,925   5,431   4,626
    Increase/Decrease in operating assets and liabilities   (1,505)   520   (1,594)   613
    NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES   3,623   4,445   3,837   5,239
    Short term investments (2)   (17,952)   —   (19,013)   —
    Additions to capitalized assets produced by the company and other capital expenditures   (1,786)   (1,638)   (1,892)   (1,931)
    NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES   (19,739)   (1,638)   (20,905)   (1,931)
    NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES   21,399   20,266   22,663   23,887
    NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS   (2,089)   (585)   (9,717)   (3,992)
    NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS   3,193   22,488   (4,123)   23,204

    (1) including share based compensation expenses for 1,345 thousand of Euros for the nine months ended September 30, and 1,900 thousand of Euros for the full year ended December 31, 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 nine months’ noon buying rate of 1 Euro = 1.0591 USD, and 2021 average twelve months noon buying rate of 1 Euro = 1.1787 USD

    EDAP TMS S.A.
    UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
    nine months ended September 30, 2022
    (Amounts in thousands of Euros)

                                           
           HIFU                ESWL                Distribution                Reconciling      Total After            
        Division       Division       Division       Items   Consolidation      
    Sales of goods   5,657        2,914        18,398        —   26,969       
    Sales of RPPs & Leases   3,166        792        218        —   4,176       
    Sales of spare parts & services   1,441        4,261        2,543        —   8,245       
    TOTAL NET SALES   10,264        7,967        21,159        —   39,391       
    Other revenues   —        —        —        —   —       
    TOTAL REVENUES   10,264        7,967        21,159        —   39,391       
    GROSS PROFIT (% of Net Sales)   5,587   54.4 %   3,319   41.7 %   8,069   38.1 %   —   16,975   43.1 %
    Research & Development   (2,584)        (714)        (318)        —   (3,615)       
    Total SG&A plus depreciation   (6,560)        (2,042)        (5,711)        (1,733)   (16,047)       
    OPERATING PROFIT (LOSS)   (3,557)        563        2,040        (1,733)   (2,687)       

     

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