6-K
EDAP TMS SA (EDAP)
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, 2021
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, 2021
EDAP TMS S.A.
/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER
Exhibit 99.1
EDAP Reports Fourth Quarter 2020 Results and Provides Operational Update
| - | Generated record fourth quarter revenue of EUR 15.4 million (USD 18.3 million), an increase<br>of 28% year-over-year; HIFU revenue up 51% year-over-year |
|---|---|
| - | Generated €41.7 million revenue and profitable operating result for the full year 2020. |
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| - | Completed sales to renowned healthcare institutions, such as University of California, San Francisco Medical Center and Cleveland<br>Clinic |
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| - | Strong and increased cash position of EUR 24.7 million (USD 30.2 million) as of December 31, 2020 |
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| - | Company to host a conference call tomorrow, March 31, at 8:30 am ET |
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LYON, France, March 30, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the fourth quarter of 2020 and provided an update on strategic and operational developments.
Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “During the fourth quarter and full year 2020, we made great strides toward our mission of becoming a leader in the field of high intensity focused ultrasound. We delivered sequential revenue growth each quarter of the year notwithstanding the impact of the pandemic. We ended on a high note by delivering 28% year-over-year total revenue growth and 51% year-over-year HIFU revenue growth during the quarter, and in the process welcomed University of California, San Francisco Medical Center (UCSF) and Cleveland Clinic to our growing roster of highly regarded Focal One customers. This success was driven not only by the growing recognition of Focal One as a new treatment paradigm in the non-invasive ablation of cancerous prostate tissue, but also our strategic licensing agreement with Exact Imaging, and its lead product Exact Vu, which provides us with a comprehensive urology solution.
“Notably, we achieved all of this while delivering operating profitability for both the fourth quarter and full year and ended the year with an increased cash position of EUR 24.7 million. I believe we are well positioned to continue this momentum through 2021.”
Fourth Quarter 2020 Results
Total revenue for the fourth quarter 2020 was EUR 15.4 million (USD 18.3 million), an increase of 28.2% compared to total revenue of EUR 12.0 million (USD 13.3 million) for the same period in 2019.
Total revenue in the HIFU business for the fourth quarter 2020 was EUR 4.4 million (USD 5.2 million), a 50.8% increase compared to EUR 2.9 million (USD 3.2 million) for the fourth quarter of 2019.
Total revenue in the LITHO business for the fourth quarter 2020 was EUR 4.6 million (USD 5.5 million), a 10.6% increase compared to EUR 4.2 million (USD 4.6 million) for the fourth quarter of 2019.
Total revenue in the Distribution business for the fourth quarter 2020 was EUR 6.4 million (USD 7.6 million), a 29.7% increase compared to EUR 4.9 million (USD 5.5 million) for the fourth quarter of 2019.
Gross profit for the fourth quarter 2020 was EUR 7.0 million (USD 8.4 million), compared to EUR 5.1 million (USD 5.7 million) for the year-ago period. Gross profit margin on net sales was 45.8% in the fourth quarter of 2020, compared to 43.0% in the year-ago period. The increase in gross profit year-over-year was due to higher HIFU equipment sales.
Operating expenses were EUR 5.3 million (USD 6.3 million) for the fourth quarter of 2020, compared to EUR 5.1 million (USD 5.6 million) for the same period in 2019.
Operating profit for the fourth quarter of 2020 was EUR 1.7 million (USD 2.1 million), compared to an operating profit of EUR 0.08 million (USD 0.09 million) in the fourth quarter of 2019.
Net income for the fourth quarter of 2020 was EUR 0.8 million (USD 0.9 million), or EUR 0.03 per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.1 million), or EUR (0.03) per diluted share in the year-ago period.
Full Year 2020 Results
Total revenue for the full year 2020 was EUR 41.7 million (USD 47.8 million), a decrease of 7% compared to total revenue of EUR 44.9 million (USD 50.2 million) for the full year 2019. Full year revenue reflects the impact of the ongoing COVID-19 pandemic on the company’s activities.
Total revenue in the HIFU business for the full year 2020 was EUR 11.4 million (USD 13.1 million), a 19% decrease compared to EUR 14.1 million (USD 15.8 million) for the full year 2019.
Total revenue in the LITHO business for the full year 2020 was EUR 12.9 million (USD 14.8 million), a 9.2% decrease compared to 14.2 million (USD 15.9 million) for the full year 2019.
Total revenue in the Distribution business for the full year 2020 was EUR 17.3 million (USD 19.9 million), a 4.6% increase compared to EUR 16.6 million (USD 18.5 million) for the full year 2019.
Gross profit for the full year 2020 was EUR 18.4 million (USD 21.1 million), compared to EUR 21.0 million (USD 23.5 million) for the full year 2019. Gross profit margin on net sales was 44.1% for the full year 2020, compared to 46.8% in the prior year. The decline in gross profit year-over-year was due in part to lower sales in the HIFU business driven by COVID-19.
Operating expenses were EUR 18.1 million (USD 20.8 million) for the full year 2020, compared to EUR 18.8 million (USD 21.0 million) for the full year 2019.
Operating profit for the full year 2020 was EUR 0.3 million (USD 0.3 million), compared to an operating profit of EUR 2.2 million (USD 2.5 million) for the full year 2019.
Net loss for the full year 2020 was EUR 1.7 million (USD 2.0 million), or EUR (0.06) per diluted share, as compared to a net income of EUR 1.5 million (USD 1.7 million), or EUR 0.05 per diluted share in the prior year.
As of December 31, 2020, the Company recorded a strong cash position of EUR 24.7 million (USD 30.2 million).
ConferenceCall
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, 2021. Please refer to the information below for conference call dial-in information and webcast registration.
Conference Call & Webcast
Wednesday, March 31, 2021 @ 8:30am Eastern Time
| Domestic: | 877-451-6152 |
|---|---|
| International: | 201-389-0879 |
| Passcode: | 13717550 |
| Webcast: | http://public.viavid.com/index.php?id=143913 |
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-LookingStatements
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
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATEDSTATEMENTS OF OPERATIONS
(Amounts in thousands of Euros andU.S. Dollars, except per share data)
| Three Months Ended: | Three Months Ended: | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Dec. 31, <br><br>2020 <br><br>Euros | Dec. 31, <br><br>2019 <br><br>Euros | Dec. 31, <br>2020 <br>US | Dec. 31, <br>2019 <br>US | |||||||
| Sales of medical equipment | 11,439 | 7,972 | ||||||||
| Net Sales of RPP and Leases | 1,336 | 1,719 | ||||||||
| Sales of spare parts, supplies and Services | 2,587 | 2,259 | ||||||||
| TOTAL NET SALES | 15,363 | 11,950 | ||||||||
| Other revenues | 1 | 37 | ||||||||
| TOTAL REVENUES | 15,364 | 11,988 | ||||||||
| Cost of sales | (8,335 | ) | (6,848 | ) | ) | ) | ||||
| GROSS PROFIT | 7,029 | 5,139 | ||||||||
| Research & development expenses | (1,439 | ) | (844 | ) | ) | ) | ||||
| S, G & A expenses | (3,871 | ) | (4,216 | ) | ) | ) | ||||
| Total operating expenses | (5,310 | ) | (5,060 | ) | ) | ) | ||||
| OPERATING PROFIT (LOSS) | 1,720 | 79 | ||||||||
| Interest (expense) income, net | (46 | ) | (43 | ) | ) | ) | ||||
| Currency exchange gains (loss), net | (728 | ) | (652 | ) | ) | ) | ||||
| INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | 945 | (616 | ) | ) | ||||||
| Income tax (expense) credit | (165 | ) | (362 | ) | ) | ) | ||||
| NET INCOME (LOSS) **** | 780 | (978 | ) | ) | ||||||
| Earning per share – Basic | 0.03 | (0.03 | ) | ) | ||||||
| Average number of shares used in computation of EPS | 29,164,983 | 29,047,028 | ||||||||
| Earning per share – Diluted | 0.03 | (0.03 | ) | ) | ||||||
| Average number of shares used in computation of EPS for positive net income | 30,222,258 | 29,047,028 |
All values are in US Dollars.
NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average three months’ noon buying rate of 1 Euro = 1.1942 USD, and 2019 average three months noon buying rate of 1 Euro = 1.1133 USD
EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATEDSTATEMENTS OF OPERATIONS
(Amounts in thousands of Euros andU.S. Dollars, except per share data)
| Twelve Months Ended: | Twelve Months Ended: | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Dec. 31, <br><br>2020 <br><br>Euros | Dec. 31, <br><br>2019 <br><br>Euros | Dec. 31, <br>2020 <br>US | Dec. 31, <br>2019 <br>US | |||||||
| Sales of medical equipment | 27,523 | 30,111 | ||||||||
| Net Sales of RPP and Leases | 4,745 | 5,747 | ||||||||
| Sales of spare parts, supplies and Services | 9,382 | 9,001 | ||||||||
| TOTAL NET SALES | 41,649 | 44,859 | ||||||||
| Other revenues | 12 | 52 | ||||||||
| TOTAL REVENUES | 41,662 | 44,912 | ||||||||
| Cost of sales | (23,283 | ) | (23,909 | ) | ) | ) | ||||
| GROSS PROFIT | 18,379 | 21,002 | ||||||||
| Research & development expenses | (4,496 | ) | (3,728 | ) | ) | ) | ||||
| S, G & A expenses | (13,614 | ) | (15,074 | ) | ) | ) | ||||
| Total operating expenses | (18,110 | ) | (18,802 | ) | ) | ) | ||||
| OPERATING PROFIT (LOSS) | 269 | 2,201 | ||||||||
| Interest (expense) income, net | (98 | ) | (146 | ) | ) | ) | ||||
| Currency exchange gains (loss), net | (1,359 | ) | 136 | ) | ||||||
| Other income, net | - | - | ) | |||||||
| INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | (1,188 | ) | 2,191 | ) | ||||||
| Income tax (expense) credit | (516 | ) | (679 | ) | ) | ) | ||||
| NET INCOME (LOSS)<br> <br>**** | (1,704 | ) | 1,512 | ) | ||||||
| Earning per share – Basic | (0.06 | ) | 0.05 | ) | ||||||
| Average number of shares used in computation of EPS | 29,148,108 | 29,016,118 | ||||||||
| Earning per share – Diluted | (0.06 | ) | 0.05 | ) | ||||||
| Average number of shares used in computation of EPS for positive net income | 29,148,108 | 29,615,466 |
All values are in US Dollars.
NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average twelve months’ noon buying rate of 1 Euro = 1.1474 USD, and 2019 average twelve months noon buying rate of 1 Euro = 1.1184 USD
EDAP TMS S.A.
UNAUDITED CONSOLIDATED BALANCE SHEETSHIGHLIGHTS
(Amounts in thousands of Euros andU.S. Dollars)
| Dec. 31, <br><br>2020 <br><br>Euros | Sept. 30, <br><br>2020 <br><br>Euros | Dec. 31, <br>2020 <br>US | Sept. 30, <br>2020 <br>US | |||
|---|---|---|---|---|---|---|
| Cash, cash equivalents and short-term treasury investments | 24,696 | 19,929 | ||||
| Account receivables, net | 12,339 | 11,572 | ||||
| Inventory | 7,989 | 9,455 | ||||
| Other current assets | 369 | 604 | ||||
| TOTAL CURRENT ASSETS | 45,393 | 41,560 | ||||
| Property, plant and equipment, net | 5,599 | 5,928 | ||||
| Goodwill | 2,412 | 2,412 | ||||
| Other non-current assets | 1,790 | 1,739 | ||||
| TOTAL ASSETS | 55,193 | 51,639 | ||||
| Accounts payable & other accrued liabilities | 10,485 | 9,122 | ||||
| Deferred revenues, current portion | 2,701 | 2,695 | ||||
| Short term borrowing | 2,638 | 1,459 | ||||
| Other current liabilities | 5,679 | 5,825 | ||||
| TOTAL CURRENT LIABILITIES | 21,504 | 19,102 | ||||
| Obligations under operating and finance leases non-current | 1,653 | 1,724 | ||||
| Long term debt, non-current | 1,143 | 1,219 | ||||
| Deferred revenues, non-current | 926 | 821 | ||||
| Other long term liabilities | 3,720 | 3,626 | ||||
| TOTAL LIABILITIES | 28,945 | 26,493 | ||||
| TOTAL SHAREHOLDERS’EQUITY | 26,248 | 25,146 | ||||
| TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY | 55,193 | 51,639 |
All values are in US Dollars.
NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.2229 USD on December 31, 2020 and at the noon buying rate of 1 Euro = 1.1723 USD, on September 30, 2020
EDAP TMS S.A.
UNAUDITED CONSOLIDATED STATEMENTSOF CASH FLOWS
(Amounts in thousands of Euros)
| Dec.31, 2020 Euros | Sept.30, 2020 Euros | Dec.<br>31, <br>2020 <br>US | Sept.<br>30 <br>2020 <br>US | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| NET INCOME (LOSS) | (1,704 | ) | (2,484 | ) | ) | ) | ||||
| Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities^(1)^ | 3,790 | 2,211 | ||||||||
| OPERATING CASH FLOW | 2,087 | (273 | ) | ) | ||||||
| Increase/Decrease in operating assets and liabilities | (110 | ) | (1,735 | ) | ) | ) | ||||
| NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES | 1,977 | (2,008 | ) | ) | ||||||
| Short term investments^(2)^ | - | (1,708 | ) | ) | ||||||
| Additions to capitalized assets produced by the company and other capital expenditures | (2,011 | ) | (1,508 | ) | ) | ) | ||||
| NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES | (2,011 | ) | (3,216 | ) | ) | ) | ||||
| NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES | 3,201 | 2,248 | ||||||||
| NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | 642 | 312 | ||||||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 3,810 | (2,665 | ) | ) |
All values are in US Dollars.
^(1)^including Share based compensationexpenses for 160 thousands of Euros at the end of December 2020, and 134 thousands of Euros at the end of September 2020
^(2)^Short term investments are comprisedof money market funds
NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average twelve months’ noon buying rate of 1 Euro = 1.1474 and 2020 average nine months’ noon buying rate of 1 Euro = 1.1319 USD.
EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OFOPERATIONS BY DIVISION
TWELVE MONTHS ENDED DECEMBER 31,2020
(Amounts in thousands of Euros)
| HIFU <br><br>Division | ESWL <br><br>Division | Distribution <br><br>Division | Reconciling <br><br>Items | Total After <br><br>Consolidation | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sales of goods | 6,000 | 6,248 | 15,274 | 27,523 | |||||||||||||||
| Sales of RPPs & Leases | 3,594 | 927 | 224 | 4,745 | |||||||||||||||
| Sales of spare parts & services | 1,831 | 5,707 | 1,844 | 9,382 | |||||||||||||||
| TOTAL NET SALES | 11,425 | 12,882 | 17,342 | 41,649 | |||||||||||||||
| Other revenues | 12 | 0 | 0 | 12 | |||||||||||||||
| TOTAL REVENUES | 11,438 | 12,882 | 17,342 | 41,662 | |||||||||||||||
| GROSS PROFIT <br><br>(% of Total Revenues) | 6,293 | 55.0 % | 5,649 | 43.9% | 6,436 | 37.1% | 18,379 | 44.1% | |||||||||||
| Research & Development | (2,583 | ) | (1,555 | ) | (358 | ) | (4,496 | ) | |||||||||||
| Total SG&A plus depreciation | (4,156 | ) | (3,016 | ) | (4,976 | ) | (1,465 | ) | (13,614 | ) | |||||||||
| OPERATING PROFIT (LOSS) | (445 | ) | 1,078 | 1,102 | (1,465 | ) | 269 |