• Generated Q3 2022 total revenue of approximately EUR 12.2 million (USD 12.3 million), an increase of 29.7 % as compared to EUR 9.4 million (USD 11.1 million) for Q3 2021; nine-month year-to-date revenue increased 30.9% compared to the same period in 2021
• Generated HIFU sales of EUR $3.5 million (USD 3.5 million), representing growth of 81% over EUR 1.9 million (USD 2.3 million) for Q3 2021
• Reimbursement increase finalized: U.S. Centers for Medicare and Medicaid Services (CMS), in its final Outpatient Prospective Payment System (OPPS) rule for CY23, increased reimbursement for HIFU prostate ablation from APC Level 5 to Level 6 which increases hospital reimbursement by more than 90%
• Exited the quarter with a strong cash position of EUR 68.3 million (USD 66.8 million) as of September 30, 2022
• Conference call and webcast scheduled for tomorrow, Thursday, November 17, at 8:30 am ET
  
  

LYON, France, November 16, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the third quarter 2022.

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “For the third quarter 2022, we generated robust year-over-year revenue growth of nearly 30%, driven by continued strength in our HIFU business, which contributed revenue growth of 81% over the prior year period. This was a record calendar third quarter for our company. Clearly, our recent efforts to bolster our U.S. commercial presence are having a significant positive impact, and I believe we are well positioned to complete the year with significant momentum.”

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, “We successfully executed in the third quarter to drive adoption of Focal One HIFU as the leading non-invasive focal therapy platform. Three new hospitals purchased Focal One systems in the quarter, and we continue to see increased adoption of Focal One amongst our growing installed base. We believe the increase in 2023 reimbursement for HIFU ablation will significantly improve access in the number of facilities that choose to invest in Focal One Robotic HIFU as part of a comprehensive approach to the management of prostate cancer.”

Year-to-Date Results

Total revenue for the nine months ended September 30, 2022, was EUR 39.4 million (USD 41.7 million), an increase of 30.9% from total revenue of was EUR 30.1 million (USD 35.9 million) for the same period in 2021.

Total revenue in the HIFU business for the nine months ended September 30, 2022, was EUR 10.3 million (USD 10.9 million), an increase of 79.7% as compared to EUR 5.7 million (USD 6.8 million) for the nine months ended September 30, 2021.

Total revenue in the LITHO business for the nine months ended September 30, 2022, was EUR 8.0 million (USD 8.4 million), an increase of 3.9% from EUR 7.7 million (USD 9.1 million) for the nine months ended September 30, 2021.

Total revenue in the Distribution business for the nine months ended September 30, 2022, was EUR 21.2 million (USD 22.4 million), a 26.6% increase compared to EUR 16.7 million (USD 19.9 million) for the nine months ended September 30, 2021.

Gross profit for the nine months ended September 30, 2022, was EUR 17.0 million (USD 18.0 million), compared to EUR 12.2 million (USD 14.6 million) for the year-ago period. Gross profit margin on net sales was 43.1% for the nine months ended September 30, 2022, compared to 40.6% for the comparable period in 2021. The increase in gross profit year-over-year was due to higher sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 19.7 million (USD 20.8 million) for the nine months ended September 30, 2022, compared to EUR 14.3 million (USD 17.0 million) for the same period in 2021.

Operating loss for the nine months ended September 30, 2022, was EUR 2.7 million (USD 2.8 million), compared to an operating loss of EUR 2.1 million (USD 2.5 million) for the nine months ended September 30, 2021.

Net income for the nine months ended September 30, 2022, was EUR 2.2 million (USD 2.3 million), or EUR 0.07 per diluted share, as compared to a net loss of EUR 0.7 million (USD 0.8 million), or EUR (0.02) per diluted share in the year-ago period.

As of September 30, 2022, the company held cash, cash equivalents and short term investments of EUR 68.3 million (USD 66.8 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

Third Quarter 2022 Results

Total revenue for the third quarter 2022 was EUR 12.2 million (USD 12.3 million), a 29.7% increase as compared to total revenue of EUR 9.4 million (USD 11.1 million) for the same period in 2021.

Total revenue in the HIFU business for the third quarter 2022 was EUR 3.5 million (USD 3.5 million), an increase of 80.9% as compared to EUR 1.9 million (USD 2.3 million) for the third quarter of 2021.

Total revenue in the LITHO business for the third quarter 2022 was EUR 2.2 million (USD 2.2 million), a decrease of 12.1% from was EUR 2.5 million (USD 2.9 million) for the third quarter of 2021.

Total revenue in the Distribution business for the third quarter 2022 was EUR 6.6 million (USD 6.6 million), a 30.9% increase compared to EUR 5.0 million (USD 5.9 million) for the third quarter of 2021.

Gross profit for the third quarter 2022 was EUR 5.0 million (USD 5.0 million), compared to EUR 3.6 million (USD 4.2 million) for the year-ago period. Gross profit margin on net sales was 41.0% in the third quarter of 2022, compared to 38.4% in the year-ago period. The increase in gross profit year-over-year was driven by the higher sales effect on fixed costs.

Operating expenses were EUR 7.2 million (USD 7.2 million) for the third quarter of 2022, compared to EUR 5.5 million (USD 6.5 million) for the same period in 2021.

Operating loss for the third quarter of 2022 was EUR 2.1 million (USD 2.2 million), compared to an operating loss of EUR 1.9 million (USD 2.2 million) in the third quarter of 2021.

Net income for the third quarter of 2022 was EUR 0.0 million (USD 0.0 million), or EUR 0.00 per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.2 million), or EUR (0.03) 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, November 17, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday, November 17, 2022 @ 8:30am Eastern Time
Domestic:                877-451-6152
International:            201-389-0879
Passcode:                13733576
Webcast link:            Here

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 and www.focalone.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:
		September 30,		September 30,		September 30,		September 30,
		2022		2021		2022		2021
		Euros		Euros		$US		$US
Sales of medical equipment		8,319		5,788		8,333		6,799
Net Sales of RPP and Leases		1,214		1,104		1,216		1,297
Sales of spare parts, supplies and Services		2,710		2,548		2,714		2,993
TOTAL NET SALES		12,243		9,440		12,263		11,089
Other revenues		—		—		—		—
TOTAL REVENUES		12,243		9,440		12,263		11,089
Cost of sales		(7,226)		(5,815)		(7,238)		(6,831)
GROSS PROFIT		5,017		3,625		5,026		4,258
Research & development expenses		(1,361)		(1,064)		(1,363)		(1,250)
S, G & A expenses		(5,805)		(4,446)		(5,815)		(5,222)
Total operating expenses		(7,165)		(5,510)		(7,178)		(6,472)
OPERATING PROFIT (LOSS)		(2,148)		(1,885)		(2,152)		(2,215)
Interest (expense) income, net		(4)		(22)		(4)		(25)
Currency exchange gains (loss), net		3,020		1,003		3,025		1,178
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST		867		(904)		869		(1,062)
Income tax (expense) credit		(854)		(111)		(856)		(130)
NET INCOME (LOSS)		13		(1,015)		13		(1,192)
Earning per share – Basic		0.00		(0.03)		0.00		(0.04)
Average number of shares used in computation of EPS		33,696,543		33,448,136		33,696,543		33,448,136
Earning per share – Diluted		0.00		(0.03)		0.00		(0.04)
Average number of shares used in computation of EPS for positive net income		34,612,773		33,448,136		34,612,773		33,448,136

NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average three months’ noon buying rate of 1 Euro = 1.0017 USD, and 2021 average three months noon buying rate of 1 Euro = 1.1747 USD

EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of Euros and U.S. Dollars, except per share data)

		Nine Months Ended:				Nine Months Ended:
		September 30,		September 30,		September 30,		September 30,
		2022		2021		2022		2021
		Euros		Euros		$US		$US
Sales of medical equipment		26,969		19,176		28,563		22,858
Net Sales of RPP and Leases		4,176		3,581		4,423		4,269
Sales of spare parts, supplies and Services		8,245		7,331		8,733		8,739
TOTAL NET SALES		39,391		30,088		41,719		35,866
Other revenues		—		4		—		5
TOTAL REVENUES		39,391		30,092		41,719		35,871
Cost of sales		(22,416)		(17,881)		(23,741)		(21,315)
GROSS PROFIT		16,975		12,211		17,978		14,556
Research & development expenses		(3,615)		(2,840)		(3,829)		(3,385)
S, G & A expenses		(16,047)		(11,444)		(16,995)		(13,642)
Total operating expenses		(19,662)		(14,284)		(20,824)		(17,027)
OPERATING PROFIT (LOSS)		(2,687)		(2,073)		(2,846)		(2,471)
Interest (expense) income, net		(62)		122		(66)		145
Currency exchange gains (loss), net		6,001		1,574		6,355		1,876
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST		3,251		(378)		3,443		(450)
Income tax (expense) credit		(1,054)		(288)		(1,117)		(343)
NET INCOME (LOSS)		2,197		(665)		2,327		(793)
Earning per share – Basic		0.07		(0.02)		0.07		(0.02)
Average number of shares used in computation of EPS		33,544,003		32,881,747		33,544,003		32,881,747
Earning per share – Diluted		0.06		(0.02)		0.07		(0.02)
Average number of shares used in computation of EPS for positive net income		34,301,115		32,881,747		34,301,115		32,881,747

NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average nine months’ noon buying rate of 1 Euro = 1.0591 USD, and 2021 average nine months noon buying rate of 1 Euro = 1.1920 USD

EDAP TMS S.A.
UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS
(Amounts in thousands of Euros and U.S. Dollars)

		September 30,		December 31,		September 30,		December 31,
		2022		2021		2022		2021
		Euros		Euros		$US		$US
Cash, cash equivalents and short-term treasury investments		68,329		47,183		66,845		53,405
Account receivables, net		15,131		12,118		14,802		13,716
Inventory		9,561		7,499		9,353		8,487
Other current assets		1,007		581		985		658
TOTAL CURRENT ASSETS		94,027		67,382		91,985		76,267
Property, plant and equipment, net		6,133		5,173		6,000		5,855
Goodwill		2,412		2,412		2,359		2,730
Other non-current assets		2,230		2,260		2,181		2,558
TOTAL ASSETS		104,801		77,226		102,525		87,409
Accounts payable & other accrued liabilities		13,366		10,786		13,076		12,208
Deferred revenues, current portion		4,230		3,408		4,138		3,857
Short term borrowing		1,237		1,914		1,210		2,167
Other current liabilities		2,688		1,843		2,629		2,086
TOTAL CURRENT LIABILITIES		21,521		17,951		21,053		20,318
Obligations under operating and finance leases non-current		1,583		1,318		1,548		1,492
Long term debt, non-current		4,021		4,930		3,934		5,580
Deferred revenues, non-current		331		440		324		498
Other long term liabilities		3,104		2,534		3,037		2,868
TOTAL LIABILITIES		30,560		27,172		29,896		30,755
TOTAL SHAREHOLDERS’EQUITY		74,242		50,054		72,629		56,655
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY		104,801		77,226		102,525		87,409

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 0.9783 USD, on September 30, 2022 and at the noon buying rate of 1 Euro = 1.1319 USD, on December 31, 2021.

EDAP TMS S.A.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of Euros)

		Nine Months Ended		Twelve Months Ended		Nine Months Ended		Twelve Months Ended
		September 30,		December 31,		September 30,		December 31,
		2022		2021		2022		2021
		(Euros)		(Euros)		($US)		($US)
NET INCOME (LOSS)		2,197		700		2,327		825
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)		2,931		3,225		3,104		3,801
OPERATING CASH FLOW		5,128		3,925		5,431		4,626
Increase/Decrease in operating assets and liabilities		(1,505)		520		(1,594)		613
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES		3,623		4,445		3,837		5,239
Short term investments (2)		(17,952)		—		(19,013)		—
Additions to capitalized assets produced by the company and other capital expenditures		(1,786)		(1,638)		(1,892)		(1,931)
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES		(19,739)		(1,638)		(20,905)		(1,931)
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES		21,399		20,266		22,663		23,887
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS		(2,089)		(585)		(9,717)		(3,992)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS		3,193		22,488		(4,123)		23,204

⁽¹⁾ including share based compensation expenses for 1,345 thousand of Euros for the nine months ended September 30, and 1,900 thousand of Euros for the full year ended December 31, 2021.

⁽²⁾ short term investments are comprised of money market funds.

NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average nine months’ noon buying rate of 1 Euro = 1.0591 USD, and 2021 average twelve months noon buying rate of 1 Euro = 1.1787 USD

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
nine months ended September 30, 2022
(Amounts in thousands of Euros)

		HIFU				ESWL				Distribution				Reconciling		Total After
		Division				Division				Division				Items		Consolidation
Sales of goods		5,657				2,914				18,398				—		26,969
Sales of RPPs & Leases		3,166				792				218				—		4,176
Sales of spare parts & services		1,441				4,261				2,543				—		8,245
TOTAL NET SALES		10,264				7,967				21,159				—		39,391
Other revenues		—				—				—				—		—
TOTAL REVENUES		10,264				7,967				21,159				—		39,391
GROSS PROFIT (% of Net Sales)		5,587		54.4	%	3,319		41.7	%	8,069		38.1	%	—		16,975		43.1	%
Research & Development		(2,584)				(714)				(318)				—		(3,615)
Total SG&A plus depreciation		(6,560)				(2,042)				(5,711)				(1,733)		(16,047)
OPERATING PROFIT (LOSS)		(3,557)				563				2,040				(1,733)		(2,687)

 

Attachment

• EDAP TMS PR Q3 2022 final