• EDAP Reports Second Quarter 2022 Results

    Источник: Nasdaq GlobeNewswire / 24 авг 2022 16:35:00   America/New_York

    • Announced Focal One® HIFU reimbursement raised to urology APC Level 6 under CMS Outpatient Prospective Payment System (OPPS) proposed rule for CY23
    • Second quarter 2022 total revenue of approximately EUR 14.2 million (USD 15.0 million), an increase of 36.7% as compared to EUR 10.4 million (USD 12.4 million) for the second quarter 2021
    • 79% growth in HIFU revenues for the first half of 2022 compared to same period in 2021
    • Strong cash position of $48.5 million as of June 30, 2022
    • Company to host Focal One Expert User Panel event in New York City on Thursday, September 29
    • Second quarter conference call and webcast scheduled for tomorrow, Thursday, August 25, at 8:30 am ET

    LYON, France, August 24, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the second quarter 2022.

    Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “For the second quarter 2022, we generated strong year-over-year revenue growth of nearly 37% driven by contribution from all three business segments, including our core HIFU business, which grew nearly 50% over the prior year period. The measured investments that we continue to make in our US team and infrastructure continue to bear fruit as HIFU, and specifically Focal One, becomes integral to the modern prostate cancer treatment paradigm.”

    “Our pipeline of sales prospects continues to grow, driven by a combination of new world-renowned healthcare institutions that have adopted Focal One, and champion this technology, and our growing presence at important medical meetings such as the annual meeting of the American Urological Association this past May. These trends, together with the proposed increase in reimbursement for CY23 indicated in the preliminary CMS Outpatient Prospective Payment System (OPPS) rule, give me great optimism for the future adoption of our Focal One platform.” Mr. Oczachowski concluded.

    Ryan Rhodes, Chief Executive Officer of EDAP US, stated, “Following the close of the second quarter, we learned that the Centers for Medicare and Medicaid Services, in its proposed OPPS rule for calendar year 2023, raised Focal One HIFU reimbursement to APC Level 6 from Level 5 currently. It is difficult to overstate the positive impact such a change would have on expanding patient procedure access should the increase stand in the final rule, which we expect to be published in November. We are very pleased with this proposed increase to hospital reimbursement and believe it more accurately reflects the significant clinical value that HIFU brings to the urology suite.”

    “We also will be hosting an in-person Focal One Expert User Panel Event in New York City in September, to coincide with Prostate Cancer Awareness Month. The event will feature presentations from several renowned thought leaders and will also include a demonstration of the Focal One procedure.”

    Year-to-Date Results

    Total revenue for the six months ended June 30, 2022, was EUR 27.1 million (USD 29.5 million), an increase of 31.5% from total revenue of was EUR 20.7 million (USD 24.8 million) for the same period in 2021.

    Total revenue in the HIFU business for the six months ended June 30, 2022, was EUR 6.8 million (USD 7.4 million), an increase of 78.8% as compared to EUR 3.8 million (USD 4.6 million) for the six months ended June 30, 2021.

    Total revenue in the LITHO business for the six months ended June 30, 2022, was EUR 5.8 million (USD 6.3 million), an increase of 11.6% from EUR 5.2 million (USD 6.2 million) for the six months ended June 30, 2021.

    Total revenue in the Distribution business for the six months ended June 30, 2022, was EUR 14.6 million (USD 15.9 million), a 24.8% increase compared to EUR 11.7 million (USD 14.0 million) for the six months ended June 30, 2021.

    Gross profit for the six months ended June 30, 2022, was EUR 12.0 million (USD 13.0 million), compared to EUR 8.6 million (USD 10.3 million) for the year-ago period. Gross profit margin on net sales was 44.0% for the six months ended June 30, 2022, compared to 41.6% 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 12.5 million (USD 13.6 million) for the six months ended June 30, 2022, compared to EUR 8.8 million (USD 10.5 million) for the same period in 2021.

    Operating loss for the six months ended June 30, 2022, was EUR 0.5 million (USD 0.6 million), compared to an operating loss of EUR 0.2 million (USD 0.2 million) for the six months ended June 30, 2021.

    Net income for the six months ended June 30, 2022, was EUR 2.2 million (USD 2.4 million), or EUR 0.06 per diluted share, as compared to a net income of EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share in the year-ago period.

    As of June 30, 2022, the company held cash and cash equivalents of EUR 46.3 million (USD 48.5 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

    Second Quarter 2022 Results

    Total revenue for the second quarter 2022 was EUR 14.2 million (USD 15.0 million), a 36.7% increase as compared to total revenue of EUR 10.4 million (USD 12.4 million) for the same period in 2021.

    Total revenue in the HIFU business for the second quarter 2022 was EUR 3.0 million (USD 3.2 million), an increase of 49.3% as compared to EUR 2.0 million (USD 2.4 million) for the second quarter of 2021.

    Total revenue in the LITHO business for the second quarter 2022 was EUR 3.6 million (USD 3.8 million), an increase of 55.7% from was EUR 2.3 million (USD 2.7 million) for the second quarter of 2021.

    Total revenue in the Distribution business for the second quarter 2022 was EUR 7.6 million (USD 8.1 million), a 25.5% increase compared to EUR 6.1 million (USD 7.3 million) for the second quarter of 2021.

    Gross profit for the second quarter 2022 was EUR 6.2 million (USD 6.6 million), compared to EUR 4.2 million (USD 5.1 million) for the year-ago period. Gross profit margin on net sales was 43.8% in the second quarter of 2022, compared to 40.7% 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 6.6 million (USD 7.0 million) for the second quarter of 2022, compared to EUR 4.6 million (USD 5.6 million) for the same period in 2021.

    Operating loss for the second quarter of 2022 was EUR 0.4 million (USD 0.5 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2021.

    Net income for the second quarter of 2022 was EUR 1.8 million (USD 1.9 million), or EUR 0.05 per diluted share, as compared to a net loss of EUR 0.4 million (USD 0.5 million), or EUR 0.01 per diluted share in the year-ago period.

    In-person Focal One Expert User Panel Event
    The management team of EDAP will host a In-person Focal One Expert User Panel Event in New York City on Thursday, September 29. https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MjAxNg==

    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, August 25, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

    Conference Call & Webcast
    Thursday, August 25, 2022 @ 8:30am Eastern Time
    Domestic:                877-451-6152
    International:            201-389-0879
    Passcode:                13731177
    Webcast:                https://viavid.webcasts.com/starthere.jsp?ei=1558239&tp_key=295933838c

    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:
         June 30,     June 30,     June 30,     June 30, 
      2022 2021 2022 2021
      Euros Euros $US $US
    Sales of medical equipment  9,684  6,696  10,245  8,051
    Net Sales of RPP and Leases  1,646  1,265  1,741  1,521
    Sales of spare parts, supplies and Services  2,820  2,387  2,984  2,870
    TOTAL NET SALES  14,151  10,349  14,969  12,443
    Other revenues  —  1  —  2
    TOTAL REVENUES  14,151  10,350  14,969  12,445
    Cost of sales  (7,949)  (6,134)  (8,409)  (7,376)
    GROSS PROFIT  6,201  4,216  6,560  5,069
    Research & development expenses  (1,174)  (925)  (1,242)  (1,112)
    S, G & A expenses  (5,455)  (3,718)  (5,770)  (4,470)
    Total operating expenses  (6,629)  (4,642)  (7,012)  (5,582)
    OPERATING PROFIT (LOSS)  (427)  (427)  (452)  (513)
    Interest (expense) income, net  (29)  (20)  (31)  (25)
    Currency exchange gains (loss), net  2,412  82  2,551  98
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST  1,955  (365)  2,068  (439)
    Income tax (expense) credit  (128)  (58)  (136)  (70)
    NET INCOME (LOSS)  1,827  (424)  1,933  (509)
    Earning per share – Basic  0.05  (0.01)  0.06  (0.02)
    Average number of shares used in computation of EPS  33,469,053  32,220,414  33,469,053  32,220,414
    Earning per share – Diluted  0.05  (0.01)  0.06  (0.02)
    Average number of shares used in computation of EPS for positive net income  34,130,859  32,220,414  34,130,859  32,220,414

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average three months’ noon buying rate of 1 Euro = 1.0579 USD, and 2021 average three months noon buying rate of 1 Euro = 1.2024 USD 

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

             
      Six Months Ended: Six Months Ended:
         June 30,     June 30,     June 30,     June 30, 
      2022 2021 2022 2021
      Euros Euros $US $US
    Sales of medical equipment  18,650  13,387  20,287  16,075
    Net Sales of RPP and Leases  2,963  2,477  3,223  2,975
    Sales of spare parts, supplies and Services  5,536  4,784  6,021  5,744
    TOTAL NET SALES  27,148  20,648  29,531  24,794
    Other revenues  —  4  —  5
    TOTAL REVENUES  27,148  20,653  29,531  24,799
    Cost of sales  (15,190)  (12,066)  (16,524)  (14,488)
    GROSS PROFIT  11,958  8,587  13,008  10,311
    Research & development expenses  (2,255)  (1,776)  (2,453)  (2,132)
    S, G & A expenses  (10,242)  (6,998)  (11,141)  (8,403)
    Total operating expenses  (12,497)  (8,774)  (13,594)  (10,536)
    OPERATING PROFIT (LOSS)  (539)  (188)  (586)  (225)
    Interest (expense) income, net  (58)  143  (63)  172
    Currency exchange gains (loss), net  2,981  571  3,243  685
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST  2,384  527  2,593  632
    Income tax (expense) credit  (200)  (177)  (218)  (213)
    NET INCOME (LOSS)  2,184  350  2,375  420
    Earning per share – Basic  0.07  0.01  0.07  0.01
    Average number of shares used in computation of EPS  33,467,594  30,705,356  33,467,594  30,705,356
    Earning per share – Diluted  0.06  0.01  0.07  0.01
    Average number of shares used in computation of EPS for positive net income  34,075,033  31,994,402  34,075,033  31,994,402

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average six months’ noon buying rate of 1 Euro = 1.0878 USD, and 2021 average six months noon buying rate of 1 Euro = 1.2008 USD

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

             
         June 30,     December 31,     June 30,     December 31, 
      2022 2021 2022 2021
      Euros Euros $US $US
    Cash, cash equivalents and short-term treasury investments  46,334  47,183  48,507  53,405
    Account receivables, net  15,888  12,118  16,633  13,716
    Inventory  7,906  7,499  8,277  8,487
    Other current assets  725  581  759  658
    TOTAL CURRENT ASSETS  70,853  67,382  74,176  76,267
    Property, plant and equipment, net  5,820  5,173  6,093  5,855
    Goodwill  2,412  2,412  2,525  2,730
    Other non-current assets  2,210  2,260  2,314  2,558
    TOTAL ASSETS  81,294  77,226  85,107  87,409
    Accounts payable & other accrued liabilities  11,348  10,786  11,881  12,208
    Deferred revenues, current portion  3,958  3,408  4,143  3,857
    Short term borrowing  1,906  1,914  1,995  2,167
    Other current liabilities  2,590  1,843  2,711  2,086
    TOTAL CURRENT LIABILITIES  19,802  17,951  20,730  20,318
    Obligations under operating and finance leases non-current  1,427  1,318  1,494  1,492
    Long term debt, non-current  4,390  4,930  4,596  5,580
    Deferred revenues, non-current  351  440  368  498
    Other long term liabilities  3,060  2,534  3,204  2,868
    TOTAL LIABILITIES  29,029  27,172  30,391  30,755
    TOTAL SHAREHOLDERS’EQUITY  52,265  50,054  54,716  56,655
    TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY  81,294  77,226  85,107  87,409

    NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.0469 USD on June 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)

             
         Six Months Ended    Twelve Months Ended    Six Months Ended    Twelve Months Ended
      June 30,  December 31,  June 30,  December 31, 
      2022 2021 2022 2021
      (Euros) (Euros) ($US) ($US)
    NET INCOME (LOSS)  2,184  700  2,375  825
    Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)  1,967  3,225  2,140  3,801
    OPERATING CASH FLOW  4,151  3,925  4,515  4,626
    Increase/Decrease in operating assets and liabilities  (2,901)  520  (3,156)  613
    NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES  1,250  4,445  1,359  5,239
             
    Additions to capitalized assets produced by the company and other capital expenditures  (1,192)  (1,638)  (1,297)  (1,931)
    NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES  (1,192)  (1,638)  (1,297)  (1,931)
    NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES  34  20,266  37  23,887
    NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS  (941)  (585)  (4,997)  (3,992)
    NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS  (849)  22,488  (4,898)  23,204

    (1) including share based compensation expenses for 936 thousand of Euros for the six months ended June 30, 2022 and 1,900 thousand of Euros for the full year ended December 31, 2021.

    NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average six months’ noon buying rate of 1 Euro = 1.0878 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
    SIX MONTHS ENDED JUNE 30, 2022
    (Amounts in thousands of Euros)

                        
         HIFU            ESWL            Distribution            Reconciling    Total After         
      Division   Division   Division   Items Consolidation   
    Sales of goods  3,606     2,291     12,753     —  18,650    
    Sales of RPPs & Leases  2,252     569     141     —  2,963    
    Sales of spare parts & services  937     2,917     1,682     —  5,536    
    TOTAL NET SALES  6,795     5,777     14,576     —  27,148    
    Other revenues  —     —     —     —  —    
    TOTAL REVENUES  6,795     5,777     14,576     —  27,148    
    GROSS PROFIT (% of Net Sales)  3,797  55.9%   2,536  43.9%   5,624  38.6%   —  11,958  44.0%
    Research & Development  (1,560)     (466)     (229)     —  (2,255)    
    Total SG&A plus depreciation  (3,990)     (1,356)     (3,696)     (1,201)  (10,242)    
    OPERATING PROFIT (LOSS)  (1,752)     714     1,699     (1,201)  (539)    


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