EDAP Reports Fourth Quarter and Full Year 2021 Results
03/30/2022 - 04:35 PM
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 , 202 2 @ 8:30am Eastern Time 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 bconfort@edap-tms.com
Investor Contact 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 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% (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)
