UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
March 30, 2022
Commission File Number: 0-29374
EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ x] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: March 30, 2022
EDAP TMS S.A.
/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER
EDAP Reports Fourth Quarter and Full Year 2021 Results
| - | 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 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |||||||||||||
Euros | Euros | $US | $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 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |||||||||||||
| Euros | Euros | $US | $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) | ||||||||||||||||||||||||||||||