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EDAP Reports Fourth Quarter 2020 Results and Provides Operational Update
المصدر: Nasdaq GlobeNewswire / 30 مارس 2021 16:35:00 America/New_York
- Generated record fourth quarter revenue of EUR 15.4 million (USD 18.3 million), an increase 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.
- Completed sales to renowned healthcare institutions, such as University of California, San Francisco Medical Center and Cleveland Clinic
- Strong and increased cash position of EUR 24.7 million (USD 30.2 million) as of December 31, 2020
- Company to host a conference call tomorrow, March 31, at 8:30 am ET
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).
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, 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=143913Following 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.comInvestor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.comEDAP 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,
2020
Euros
Dec. 31,
2019
EurosDec. 31,
2020
$USDec. 31,
2019
$USSales of medical equipment 11,439 7,972 13,661 8,876 Net Sales of RPP and Leases 1,336 1,719 1,596 1,914 Sales of spare parts, supplies and Services 2,587 2,259 3,089 2,515 TOTAL NET SALES 15,363 11,950 18,346 13,305 Other revenues 1 37 2 42 TOTAL REVENUES 15,364 11,988 18,348 13,346 Cost of sales (8,335) (6,848) (9,953) (7,624) GROSS PROFIT 7,029 5,139 8,394 5,722 Research & development expenses (1,439) (844) (1,718) (939) S, G & A expenses (3,871) (4,216) (4,622) (4,694) Total operating expenses (5,310) (5,060) (6,341) (5,633) OPERATING PROFIT (LOSS) 1,720 79 2,053 88 Interest (expense) income, net (46) (43) (55) (48) Currency exchange gains (loss), net (728) (652) (869) (726) INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST 945 (616) 1,129 (685) Income tax (expense) credit (165) (362) (197) (403) NET INCOME (LOSS)
780 (978) 932 (1,088) Earning per share – Basic 0.03 (0.03) 0.03 (0.04) Average number of shares used in computation of EPS 29,164,983 29,047,028 29,164,983 29,047,028 Earning per share – Diluted 0.03 (0.03) 0.03 (0.04) Average number of shares used in computation of EPS for positive net income
30,222,258 29,047,028 30,222,258 29,047,028 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 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,
2020
Euros
Dec. 31,
2019
EurosDec. 31,
2020
$USDec. 31,
2019
$USSales of medical equipment 27,523 30,111 31,581 33,678 Net Sales of RPP and Leases 4,745 5,747 5,445 6,428 Sales of spare parts, supplies and Services 9,382 9,001 10,765 10,067 TOTAL NET SALES 41,649 44,859 47,791 50,173 Other revenues 12 52 14 59 TOTAL REVENUES 41,662 44,912 47,805 50,231 Cost of sales (23,283) (23,909) (26,716) (26,741) GROSS PROFIT 18,379 21,002 21,089 23,490 Research & development expenses (4,496) (3,728) (5,159) (4,169) S, G & A expenses (13,614) (15,074) (15,621) (16,859) Total operating expenses (18,110) (18,802) (20,780) (21,029) OPERATING PROFIT (LOSS) 269 2,201 309 2,461 Interest (expense) income, net (98) (146) (112) (163) Currency exchange gains (loss), net (1,359) 136 (1,559) 152 Other income, net - - (1) - INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST (1,188) 2,191 (1,363) 2,451 Income tax (expense) credit (516) (679) (592) (760) NET INCOME (LOSS)
(1,704) 1,512 (1,955) 1,691 Earning per share – Basic (0.06) 0.05 (0.07) 0.06 Average number of shares used in computation of EPS 29,148,108 29,016,118 29,148,108 29,016,118 Earning per share – Diluted (0.06) 0.05 (0.07) 0.06 Average number of shares used in computation of EPS for positive net income
29,148,108 29,615,466 29,148,108 29,615,466 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 SHEETS HIGHLIGHTS
(Amounts in thousands of Euros and U.S. Dollars)Dec. 31,
2020
Euros
Sept. 30,
2020
EurosDec. 31,
2020
$USSept. 30,
2020
$USCash, cash equivalents and short-term treasury investments 24,696 19,929 30,201 23,364 Account receivables, net 12,339 11,572 15,090 13,567 Inventory 7,989 9,455 9,771 11,084 Other current assets 369 604 451 708 TOTAL CURRENT ASSETS 45,393 41,560 55,513 48,722 Property, plant and equipment, net 5,599 5,928 6,847 6,950 Goodwill 2,412 2,412 2,949 2,827 Other non-current assets 1,790 1,739 2,189 2,039 TOTAL ASSETS 55,193 51,639 67,498 60,538 Accounts payable & other accrued liabilities 10,485 9,122 12,823 10,694 Deferred revenues, current portion 2,701 2,695 3,304 3,160 Short term borrowing 2,638 1,459 3,227 1,711 Other current liabilities 5,679 5,825 6,945 6,829 TOTAL CURRENT LIABILITIES 21,504 19,102 26,298 22,394 Obligations under operating and finance leases non-current 1,653 1,724 2,022 2,021 Long term debt, non-current 1,143 1,219 1,397 1,429 Deferred revenues, non-current 926 821 1,132 963 Other long term liabilities 3,720 3,626 4,549 4,251 TOTAL LIABILITIES 28,945 26,493 35,399 31,059 TOTAL SHAREHOLDERS’EQUITY 26,248 25,146 32,099 29,480 TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY 55,193 51,639 67,498 60,538 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 STATEMENTS OF CASH FLOWS
(Amounts in thousands of Euros)Dec. 31, 2020
EurosSept. 30, 2020
EurosDec. 31, 2020
$USSept. 30 2020
$USNET INCOME (LOSS) (1,704) (2,484) (1,955) (2,812) Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1) 3,790 2,211 4,349 2,503 OPERATING CASH FLOW 2,087 (273) 2,394 (309) Increase/Decrease in operating assets and liabilities (110) (1,735) (126) (1,964) NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES 1,977 (2,008) 2,269 (2,273) Short term investments(2) - (1,708) - (1,933) Additions to capitalized assets produced by the company and other capital expenditures (2,011) (1,508) (2,307) (1,707) NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES (2,011) (3,216) (2,307) (3,640) NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES 3,201 2,248 3,673 2,544 NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS 642 312 3,118 1,281 NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 3,810 (2,665) 6,752 (2,088) (1) including Share based compensation expenses 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 comprised of 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 OF OPERATIONS BY DIVISION
TWELVE MONTHS ENDED DECEMBER 31, 2020
(Amounts in thousands of Euros)
HIFU
Division
ESWL
Division
Distribution
Division
Reconciling
Items
Total After Consolidation
Sales of goods
6,000
6,248
15,274
27,523Sales 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
(% 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)
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