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EDAP EDAP TMS

Filed: 25 Aug 21, 4:40pm

 

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

August 25, 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: August 25, 2021

EDAP TMS S.A.

 

/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER

 

 


EDAP Reports Second Quarter 2021 Results and Provides Operational Update

-Total revenue for the first half 2021 of EUR 20.7 million (USD $24.8 million) increased 22.5% over the same period of the prior year
-Net income was EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share, for the first half of 2021
-Cash balance of EUR 45 million (USD $53.3 million) as of June 30, 2021
-Second quarter U.S. HIFU treatment volumes increased 79% over the comparable period in 2020; strong leading indicator of Focal One adoption
-CMS Advisory Panel on Hospital Outpatient Payment (HOP panel), at its summer meeting, unanimously recommended increasing reimbursement for HIFU prostate ablation to APC Level 6 in 2022 from Level 5 currently
-Company to host a conference call tomorrow, August 26, at 8:30 am ET

LYON, France, August 25, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the second quarter of 2021 and provided an update on strategic and operational developments. 

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “We were very pleased during the second quarter to see continued strong growth in U.S. Focal One treatment volumes, a metric that we believe reflects accelerating HIFU adoption as a prostate cancer treatment alternative. While the ongoing COVID pandemic continues to weigh on hospital capital spending, we nonetheless continued to build a robust pipeline of Focal One and ExactVu pipeline opportunities, and we are optimistic that we will close additional high-profile sales this year.

“On the reimbursement front, just a few days ago, the CMS HOP panel voted unanimously in favor of increasing reimbursement for HIFU prostate ablation to APC Level 6 next year from Level 5 currently. Even if the HOP panel has only an advisory role to CMS, we believe this is a strong signal and further recognition of the value of HIFU in this indication. We hope this will be taken into account by CMS when building the final rule, which will be published in December of this year. If this is the case, reimbursement for Focal One HIFU would increase from an average of approximately $4,500 per procedure this year to an average of approximately $8,500 per procedure in 2022. This increase, if implemented, could be a significant catalyst to accelerating Focal One sales in 2022 and beyond.

“Importantly, our U.S. expansion plans, led by new U.S. subsidiary CEO Ryan Rhodes, are progressing and we are well financed with more than $53 million on our balance sheet. I believe we are poised for a strong back half of the year and accelerating HIFU momentum heading into 2022.”

For the first six months 2021 Results

Total revenue for the first half of 2021 was EUR 20.7 million (USD 24.8 million), an increase of 22.5% compared to total revenue of EUR 16.9 million (USD 18.7 million) for the same period in 2020.

Total revenue in the HIFU business for the first six months of 2021 was EUR 3.8 million (USD 4.6 million), a decline of 15.1% as compared to EUR 4.5 million (USD 4.9 million) for the first six months of 2020.

Total revenue in the LITHO business for the first six months of 2021 was EUR 5.2 million (USD 6.2 million), a decline of 11.8% from EUR 5.9 million (USD 6.5 million) for the first six months of 2020.

Total revenue in the Distribution business for the first six months of 2021 was EUR 11.7 million (USD 14.0 million), a 79.0% increase compared to EUR 6.5 million (USD 7.2 million) for the first six months of 2020.

Gross profit for the first six months of 2021 was EUR 8.6 million (USD 10.3 million), compared to EUR 7.4 million (USD 8.2 million) for the year-ago period. Gross profit margin on net sales was 41.6% in the first six months of 2021, compared to 43.9% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 8.8 million (USD 10.5 million) for the first six months of 2021, compared to EUR 8.5 million (USD 9.5 million) for the same period in 2020.

Operating loss for the first six months of 2021 was EUR 0.2 million (USD 0.2 million), compared to an operating loss of EUR 1.2 million (USD 1.3 million) for the same period in 2020.

 

 

Net income for the first six months of 2021 was EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share, as compared to a net loss of EUR 1.5 million (USD 1.6 million), or EUR (0.05) per diluted share in the year-ago period.

As of June 30, 2021, the company held cash and cash equivalents of EUR 45 million (USD 53.3 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

Second Quarter 2021 Results

Total revenue for the second quarter 2021 was EUR 10.4 million (USD 12.4 million), an increase of 11.8% compared to total revenue of EUR 9.3 million (USD 10.3 million) for the same period in 2020.

Total revenue in the HIFU business for the second quarter 2021 was EUR 2.0 million (USD 2.4 million), a decline of 21.8% as compared to EUR 2.6 million (USD 2.8 million) for the second quarter of 2020.

Total revenue in the LITHO business for the second quarter 2021 was EUR 2.3 million (USD 2.7 million), a decline of 22.6% from EUR 2.9 million (USD 3.2million) for the second quarter of 2020.

Total revenue in the Distribution business for the second quarter 2021 was EUR 6.1 million (USD 7.3 million), a 61.6% increase compared to EUR 3.8 million (USD 4.2 million) for the second quarter of 2020.

Gross profit for the second quarter 2021 was EUR 4.2 million (USD 5.1 million), compared to EUR 4.3 million (USD 4.8 million) for the year-ago period. Gross profit margin on net sales was 40.7% in the second quarter of 2021, compared to 46.8% in the year-ago period.

Operating expenses were EUR 4.6 million (USD 5.6 million) for the second quarter of 2021, compared to EUR 4.0 million (USD 4.5 million) for the same period in 2020.

Operating loss for the second quarter of 2021 was EUR 0.4 million (USD 0.5 million), compared to an operating profit of EUR 0.3 million (USD 0.3 million) in the second quarter of 2020.

Net loss for the second quarter of 2021 was EUR 0.4 million (USD 0.5 million), or EUR (0.01) per diluted share, as compared to a net loss of EUR 0.2 million (USD 0.2 million), or EUR (0.01) per diluted share in the year-ago period.

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 26, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

 

Conference Call & Webcast
Thursday, August 26, 2021 @ 8:30am Eastern Time

Domestic:877-451-6152
International:201-389-0879
Passcode:13721942
Webcast:http://public.viavid.com/index.php?id=145982

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

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@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,

2021

Euros

 

June. 30,

2020

Euros

 

June. 30,

2021

$US

 

June. 30,

2020 

$US
Sales of medical equipment  6,696   5,975   8,051   6,628 
Net Sales of RPP and Leases  1,265   947   1,521   1,050 
Sales of spare parts, supplies and Services  2,387   2,311   2,870   2,564 
TOTAL NET SALES  10,349   9,233   12,443   10,242 
Other revenues  1   23   2   25 
TOTAL REVENUES  10,350   9,255   12,445   10,267 
Cost of sales  (6,134)  (4,931)  (7,376)  (5,470)
GROSS PROFIT  4,216   4,324   5,069   4,797 
Research & development expenses  (925)  (926)  (1,112)  (1,027)
S, G & A expenses  (3,718)  (3,096)  (4,470)  (3,434)
Total operating expenses  (4,642)  (4,022)  (5,582)  (4,461)
OPERATING PROFIT (LOSS)  (427)  303   (513)  336 
Interest (expense) income, net  (20)  (19)  (25)  (21)
Currency exchange gains (loss), net  82   (346)  98   (384)
Other income, net  —     (1)  —     (1)
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST  (365)  (63)  (439)  (70)
Income tax (expense) credit  (58)  (112)  (70)  (124)
NET INCOME (LOSS)  (424)  (175)  (509)  (194)
Earning per share – Basic  (0.01)  (0.01)  (0.02)  (0.01)
Average number of shares used in computation of EPS  32,220,414   29,141,566   32,220,414   29,141,566 
Earning per share – Diluted  (0.01)  (0.01)  (0.02)  (0.01)
Average number of shares used in computation of EPS for positive net income
  32,220,414   29,141,566   32,220,414   29,141,566 

 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average three months’ noon buying rate of 1 Euro = 1.2024 USD, and 2020 average three months noon buying rate of 1 Euro = 1.1093 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,

2021

Euros

 

June. 30,

2020

Euros

 

June. 30,

2021

$US

 

June. 30,

2020

$US

Sales of medical equipment  13,387   10,099   16,075   11,173 
Net Sales of RPP and Leases  2,477   2,202   2,975   2,436 
Sales of spare parts, supplies and Services  4,784   4,539   5,744   5,022 
TOTAL NET SALES  20,648   16,841   24,794   18,631 
Other revenues  4   24   5   27 
TOTAL REVENUES  20,653   16,865   24,799   18,658 
Cost of sales  (12,066)  (9,479)  (14,488)  (10,487)
GROSS PROFIT  8,587   7,386   10,311   8,171 
Research & development expenses  (1,776)  (1,968)  (2,132)  (2,177)
S, G & A expenses  (6,998)  (6,575)  (8,403)  (7,274)
Total operating expenses  (8,774)  (8,543)  (10,536)  (9,452)
OPERATING PROFIT (LOSS)  (188)  (1,157)  (225)  (1,280)
Interest (expense) income, net  143   (39)  172   (43)
Currency exchange gains (loss), net  571   (57)  685   (63)
Other income, net  —     0   —     (1)
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST  527   (1,254)  632   (1,388)
Income tax (expense) credit  (177)  (228)  (213)  (252)
NET INCOME (LOSS)  350   (1,483)  420   (1,640)
Earning per share – Basic  0.01   (0.05)  0.01   (0.06)
Average number of shares used in computation of EPS  30,705,356   29,141,566   30,705,356   29,141,566 
Earning per share – Diluted  0.01   (0.05)  0.01   (0.06)
Average number of shares used in computation of EPS for positive net income  31,994,402   29,141,566   31,994,402   29,141,566 

 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average six months’ noon buying rate of 1 Euro = 1.2008 USD, and 2020 average six months noon buying rate of 1 Euro = 1.1063 USD


 

 

 

EDAP TMS S.A.

UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS

(Amounts in thousands of Euros and U.S. Dollars)

 

  

June 30,

2021

Euros

 

Dec. 31,

2020

Euros

 

June 30,

2021

$US

 

Dec. 31,

2020

$US

Cash, cash equivalents and short-term treasury investments  44,961   24,696   53,272   30,201 
Account receivables, net  11,183   12,339   13,249   15,090 
Inventory  8,610   7,989   10,202   9,771 
Other current assets  618   369   732   451 
TOTAL CURRENT ASSETS  65,372   45,393   77,455   55,513 
Property, plant and equipment, net  5,135   5,599   6,084   6,847 
Goodwill  2,412   2,412   2,858   2,949 
Other non-current assets  1,704   1,790   2,019   2,189 
TOTAL ASSETS  74,622   55,193   88,415   67,498 
Accounts payable & other accrued liabilities  9,297   10,256   11,016   12,543 
Deferred revenues, current portion  3,264   2,701   3,867   3,304 
Short term borrowing  1,447   2,638   1,714   3,227 
Other current liabilities  1,340   5,679   1,588   6,945 
TOTAL CURRENT LIABILITIES  15,348   21,275   18,185   26,018 
Obligations under operating and finance leases non-current  1,415   1,653   1,677   2,022 
Long term debt, non-current  5,215   1,143   6,179   1,397 
Deferred revenues, non-current  826   926   979   1,132 
Other long term liabilities  3,628   3,949   4,298   4,829 
TOTAL LIABILITIES  26,432   28,945   31,317   35,399 
TOTAL SHAREHOLDERS’EQUITY  48,191   26,248   57,098   32,099 
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY  74,622   55,193   88,415   67,498 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1848 USD on June 30, 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)

 

  

6-months ended

June 30, 2021

Euros

 

12-months ended

Dec. 31, 2020

Euros

 

6-months ended June 30, 2021

$US

 

12-months ended

Dec. 31 2020

$US

NET INCOME (LOSS)  350   (1,704)  420   (1,955)
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)  976   3,790   1,172   4,349 
OPERATING CASH FLOW  1,326   2,087   1,592   2,394 
Increase/Decrease in operating assets and liabilities  (585)  (110)  (702)  (126)
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES  741   1,977   890   2,269 
Short term investments(2)  —     —     —     —   
Additions to capitalized assets produced by the company and other capital expenditures  (644)  (2,011)  (773)  (2,307)
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES  (644)  (2,011)  (773)  (2,307)
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES  20,368   3,201   24,457   3,673 
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS  (199)  642   (1,503)  3,118 
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS  20,266   3,810   23,071   6,752 

 


 

(1) including Share based compensation expenses for 180 thousand of Euros at the end of June 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 six months’ noon buying rate of 1 Euro = 1.2008 USD and at the 2020 average twelve months’ noon buying rate of 1 Euro = 1.1474 USD

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

SIX MONTHS ENDED JUNE 30, 2021

(Amounts in thousands of Euros)

 

  HIFU
Division
   ESWL
Division
   Distribution
Division
   Reconciling
Items
 Total After 
Consolidation
  
Sales of goods  1,151       1,881       10,356           13,387   
Sales of RPPs & Leases  1,798       540       139           2,477   
Sales of spare parts & services  846       2,755       1,182           4,784   

TOTAL NET SALES

  3,795       5,176       11,677           20,648   
Other revenues
  4       0       0           4   
TOTAL REVENUES  3,799       5,176       11,677           20,653   

GROSS PROFIT (% of Total Revenues)

  1,501   39.5%  2,472   47.8%  4,614   39.5%      8,587  41.6%
Research & Development  (1,208)      (418)      (150)          (1,776)  
Total SG&A plus depreciation  (1,946)      (1,453)      (2,689)      (911)  (6,998)  

OPERATING PROFIT (LOSS)

  (1,652)      601       1,775       (911)  (188)