2016 Highlights

• Total revenue for 2016 reached double-digit growth, increasing to EUR 35.6 million (USD 39.3 million)
• Gross margin for 2016 expanded to 46.1% compared to 42.8% during the prior year period
• Strong cash position of EUR 22.0 million (USD 23.2 million) as of December 31, 2016

LYON, France, April 3, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the fourth quarter and twelve months ended December 31, 2016, and provided an update on strategic and operational accomplishments. 

Marc Oczachowski, EDAP's Chief Executive Officer, stated, "I am thrilled with the performance of our team in 2016. We successfully grew our HIFU revenue more than 63% to EUR 13.8 million, resulting in total 2016 revenue of EUR 35.6 million. EDAP strengthened its HIFU presence in the U.S. during 2016, adding key academic centers to its HIFU user base while significantly expanding operations globally. Ablatherm® and the Focal One® continued to enjoy a warm reception from the global medical community supported by strong, positive clinical data. Notably, Focal One's innovative prostate treatment received clear recognition from the global scientific community when awarded the prestigious Prix Galien Award this past December."

Mr. Oczachowski concluded, "2016 was rich in positive events; please join us Tuesday, April 4, 2017, for a detailed discussion of our continued success and expansion."

Fourth Quarter 2016 Results

Total revenue for the fourth quarter 2016 was EUR 10.7 million (USD 11.4 million), a 9.3% decreased compared to EUR 11.8 million (USD 12.8 million) for the fourth quarter of 2015.

Total revenue in the HIFU business for the fourth quarter was EUR 4.6 million (USD 4.9 million), a 38.3% increase compared to EUR 3.3 million (USD 3.6 million) for the fourth quarter of 2015. 

For the three months ended December 31, 2016, total revenue for the Lithotripsy division was EUR 6.1 (USD 6.5 million), a 27.9% decreased compared to EUR 8.5 million (USD 9.2 million) during the year-ago period.

Gross profit for the fourth quarter 2016 was EUR 5.2 million (USD 5.6 million), compared to EUR 5.3 million (USD 5.7 million) for the year-ago period. Gross profit margin on net sales was 48.8% in the fourth quarter of 2016, compared to 45.0% in the year-ago period.

Operating expenses were EUR 4.9 million (USD 5.2 million) for the fourth quarter of 2016, compared to EUR 3.7 million (USD 4.0 million) for the same period in 2015.

Operating profit for the fourth quarter 2016 was EUR 0.3 million (USD 0.4 million), compared to EUR 1.6 million (USD 1.7 million) in the fourth quarter of 2015.

Net loss for the fourth quarter 2016 was EUR 1.3 (USD 1.4 million), or a loss of EUR 0.04 per diluted share, as compared to net income of EUR 5.1 million (USD 5.5 million), or EUR 0.18 per diluted share in the year-ago period.  Net income in the fourth quarter of 2016 included non-cash interest expense of EUR 0.4 million (USD 0.5 million) to adjust the accounting fair value of the outstanding warrants.

Year Ended 2016 Results

Total revenue for 2016 was EUR 35.6 million (USD 39.3 million), an increase of 10.4% compared to EUR 32.3 million (USD 35.6) for the year ended December 31, 2015.

Total revenue in the HIFU business for 2016 was EUR 13.8 million (USD 15.2 million), an increase of 63.0% compared to EUR 8.5 million (USD 9.4 million) for the year ended December 31, 2015.

Total revenue in the Lithotripsy business for 2016 was EUR 21.8 million (USD 24.0 million), a decrease of 8.3% compared to EUR 23.8 million (USD 26.2 million) for the year ended December 31, 2015.

Gross profit for 2016 was EUR 16.4 million (USD 18.1 million), with gross profit margin on net sales of 46.1%, compared to 42.8% during the prior year period.

The Company recorded operating profit for 2016 of EUR 0.4 million (USD 0.4 million), compared to an operating profit of EUR 0.5 million (USD 0.5 million) during the prior year period.

Full-year net income was EUR 3.8 million (USD 4.2 million), or EUR 0.13 per diluted share, as compared to a net loss of EUR 1.7 million (USD 1.8 million), or a loss of EUR 0.07 per diluted share in 2015. Full-year net income included non-cash interest income of EUR 4.0 million to adjust the accounting fair value of the outstanding warrants.

At December 31, 2016, cash and cash equivalents were EUR 22.0 million (USD 23.2 million).

Conference Call

An accompanying conference call will be conducted by Marc Oczachowski, Chief Executive Officer, and Francois Dietsch, Chief Financial Officer, to go over the results. The call will be held at 8:30 AM ET, on Tuesday, April 4, 2017. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Date: Tuesday, April 4, 2017 8:30 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: EDAP-TMS Fourth Quarter and Full Year 2016 Results Call
Webcast Registration: Click 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

EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters' range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.

Forward-Looking Statements

In addition to historical information, this press release may contain 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 device. Factors that may cause such a difference also may 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.

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

	Three Months Ended:				Three Months Ended:
	December 31,		December 31,		December 31,		December 31,
	2016		2015		2016		2015
	Euros		Euros		$US		$US
Sales of medical equipment	7,566		9,049		8,093		9,792
Net Sales of RPP and Leases	1,231		1,151		1,317		1,245
Sales of spare parts, supplies and Services	1,875		1,560		2,006		1,688
TOTAL NET SALES	10,672		11,760		11,417		12,726
Other revenues	22		32		24		35
TOTAL REVENUES	10,695		11,792		11,441		12,760
Cost of sales	-5,492		-6,495		-5,875		-7,029
GROSS PROFIT	5,203		5,297		5,566		5,732
Research & development expenses	-1,135		-565		-1,214		-612
S, G & A expenses	-3,733		-3,147		-3,994		-3,406
Total operating expenses	-4,868		-3,713		-5,208		-4,018
OPERATING PROFIT (LOSS)	335		1,584		358		1,714
Interest (expense) income, net	-444		3,710		-475		4,015
Currency exchange gains (loss), net	-698		476		-746		516
Other income (loss), net	-		5		-		5
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST	-807		5,775		-863		6,249
Income tax (expense) credit	-471		-659		-504		-713
NET INCOME (LOSS)	-1,278		5,116		-1,367		5,536
Earning per share - Basic	-0.04		0.2		-0.05		0.22
Average number of shares used in computation of EPS	28,727,616		25,254,618		28,727,616		25,254,618
Earning per share - Diluted	-0.04		0.18		-0.05		0.19
Average number of shares used in computation of EPS for positive net income	28,727,616		28,846,270		28,727,616		28,846,270

NOTE:  Translated for convenience of the reader to U.S. dollars at the 2016 average three months' noon buying rate of 1 Euro = 1.0697 USD, and 2015 average three months noon buying rate of 1 Euro = 1.0821 USD.

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

	Twelve Months Ended:				Twelve Months Ended:
	December 31,		December 31,		December 31,		December 31,
	2016		2015		2016		2015
	Euros		Euros		$US		$US
Sales of medical equipment	24,045		21,906		26,520		24,168
Net Sales of RPP and Leases	4,906		4,408		5,411		4,864
Sales of spare parts, supplies and	6,628		5,904		7,310		6,513
Services
TOTAL NET SALES	35,579		32,218		39,240		35,545
Other revenues	32		35		35		39
TOTAL REVENUES	35,611		32,253		39,276		35,584
Cost of sales	-19,200		-18,468		-21,176		-20,375
GROSS PROFIT	16,411		13,785		18,100		15,209
Research & development expenses	-3,868		-2,690		-4,266		-2,968
S, G & A expenses	-12,152		-10,608		-13,402		-11,703
Total operating  expenses	-16,019		-13,298		-17,668		-14,671
OPERATING PROFIT (LOSS)	392		488		432		538
Interest (expense) income, net	3,949		-2,094		4,355		-2,310
Currency exchange gains (loss), net	103		699		114		771
Other income (loss), net	-		-		-		-
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST	4,444		-907		4,901		-1,001
Income tax (expense) credit	-602		-759		-663		-838
NET INCOME (LOSS)	3,842		-1,667		4,238		-1,839
Earning per share - Basic	0.14		-0.07		0.15		-0.07
Average number of shares used in	27,823,313		25,021,966		27,823,313		25,021,966
computation of EPS
Earning per share - Diluted	0.13		-0.07		0.14		-0.07
Average number of shares used in computation of EPS for positive net income	29,365,583		25,021,966		29,365,583		25,021,966

NOTE:  Translated for convenience of the reader to U.S. dollars at the 2016 average twelve months noon buying rate of 1 Euro = 1.1029 USD, and 2015 average twelve months noon buying rate of 1 Euro = 1.1033 USD.

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

	Dec.  31,		Sept.  30,	Dec.  31,		Sept.  30,
	2016		2016	2016		2016
	Euros		Euros	$US		$US
Cash, cash equivalents and short term investments	21,989		18,837	23,202		21,170
Total current assets	40,514		40,694	42,750		45,734
Total current liabilities	15,010		14,547	15,838		16,349
Shareholders' Equity	24,451		25,739	25,800		28,926

NOTE:  Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.0552 USD, on December 31, 2016 and at the noon buying rate of 1 Euro = 1.1238 USD, on September 30, 2016.

EDAP TMS S.A.
CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
TWELVE MONTHS ENDED DECEMBER 31, 2016
(Amounts in thousands of Euros)

										Total After Consolidation
	HIFU Division		UDS Division				Corporate
Sales of goods	9,382		14,664								24,045
Sales of RPPs & Leases	3,547		1,359								4,906
Sales of spare parts & services	862		5,766								6,628
TOTAL NET SALES	13,791		21,789								35,579
Other revenues	28		4								32
TOTAL REVENUES	13,819		21,792								35,611
GROSS PROFIT	8,109	58.70%	8,302	38.10%							16,411	46.10%
(% of Total Revenues)
			-1,416								-3,868
Research & Development	-2,452
Total SG&A plus depreciation	-4,692		-6,145					-1,315			-12,152
OPERATING PROFIT (LOSS)	964		742					-1,315			392

Company Contact:

Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com

Investor Contact:

Rich Cockrell
CG Capital
877-889-1972
investorrelations@cg.capital

Source: EDAP TMS SA

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