LYON, France, August 24, 2023 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited financial results for the second quarter ending June 30, 2023, and announced the appointment of Ryan Rhodes to the Board of Directors of the Company.
“Our record second quarter and first half revenues and strong system placements reflect continued business momentum, as Focal One HIFU is one of the fastest-growing technology platforms enabling urologists to ablate targeted tissue in low to intermediate-risk and salvage prostate cancer patients,” said Ryan Rhodes, Chief Executive Officer of EDAP. “We also continue to make notable progress in the growth of our sales pipeline. We experienced strong year over year system placement growth in the quarter, with four Focal One units sold as compared to just one system in the second quarter of 2022. We are also pleased with strong U.S. Focal One HIFU procedure growth, which grew 85% during the second quarter of 2023 versus the second quarter of 2022. Though still in the early adoption phase, we believe there is a growing appreciation of Focal One amongst community urology practices, and we continue to make excellent progress in cultivating these relationships to help drive Focal One adoption across this large segment of the market.
“Looking ahead, our commercial success in prostate cancer and the expansion of our pipeline have created a strong foundation for growth. Increased adoption of Focal One HIFU is being driven by our state-of the-art technology platform that can be seamlessly integrated into urology practices. Further supporting growth and adoption are Focal One’s strong clinical outcomes that clearly demonstrate excellent oncologic control and faster patient recovery times. Additionally, ease of use, reduced procedure times and higher CMS reimbursement are also contributing to the adoption of Focal One HIFU technology. As we have referenced in the past, we are supporting a current Phase 3 clinical trial evaluating Focal One HIFU in the treatment of deep-infiltrating endometriosis. This trial supports Focal One HIFU as a potentially viable and less invasive treatment option for women suffering from this painful and debilitating condition. More than half of the patients are now enrolled in our 60-patient trial and we are encouraged by the progress and pace of enrollment.”
On August 23rd, 2023, the Board of Directors appointed Ryan Rhodes as a new Director of EDAP TMS. Ryan replaces Robrecht Michiels, who has resigned. As previously announced, Ryan was appointed Chief Executive Officer of Company on May 1, 2023, to lead, strengthen and accelerate the Company’s corporate strategy and development. “We would like to thank Robrecht for his significant contribution and guidance to the Board and the Company over the last several years,” said Marc Oczachowski, Chairman of the Board.
Business Update
Upcoming Corporate Presentations
Second Quarter 2023 Results
Total revenue for the second quarter of 2023 was EUR 14.3 million (USD 15.5 million), an increase of 0.9% as compared to total revenue of EUR 14.2 million (USD 15.0 million) for the same period in 2022.
Total revenue in the HIFU business for the second quarter of 2023 was EUR 4.9 million (USD 5.3 million), as compared to EUR 3.0 million (USD 3.2 million) for the second quarter of 2022. The increase was driven by four Focal One units sold in the second quarter 2023 versus one unit sold in the second quarter of 2022.
Total revenue in the LITHO business for the second quarter of 2023 was EUR 2.2 million (USD 2.4 million), as compared to EUR 3.6 million (USD 3.8 million) for the second quarter of 2022. The decline in LITHO revenue was driven by two lithotripsy units sold in the second quarter of 2023 as compared to eight units sold in the second quarter of 2022.
Total revenue in the Distribution business for the second quarter of 2023 was EUR 7.2 million (USD 7.8 million), as compared to EUR 7.6 million (USD 8.1 million) for the second quarter of 2022. The decline in Distribution revenue was driven primarily by nine ExactVu units sold during the second quarter of 2023 as compared to fifteen units sold during the second quarter of 2022.
Gross profit for the second quarter of 2023 was EUR 5.7 million (USD 6.1 million), compared to EUR 6.2 million (USD 6.6 million) for the year-ago period. Gross profit margin on net sales was 39.6% in the second quarter of 2023, compared to 43.8% in the year-ago period. The decrease in gross profit margin year-over-year was primarily due to three main factors: Distribution product mix, global inflationary price pressure on components which increased manufacturing costs, and continued investments in our U.S. service and clinical application organizations to support HIFU and long-term revenue growth.
Operating expenses were EUR 9.9 million (USD 10.7 million) for the second quarter of 2023, compared to EUR 6.6 million (USD 7.0 million) for the same period in 2022. The increase in operating expenses was primarily due to the strategic and planned build-out of the U.S. team and commercial infrastructure, variable compensation, and increased marketing activities.
Operating loss for the second quarter of 2023 was EUR 4.2 million (USD 4.6 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2022.
Net loss for the second quarter of 2023 was EUR 4.7 million (USD 5.1 million), or EUR 0.13 per diluted share, as compared to net income of EUR 1.8 million (USD 1.9 million), or EUR 0.05 per diluted share in the year-ago period.
Year-to-Date Results
Total revenue for the six months ended June 30, 2023, was EUR 29.1 million (USD 31.5 million), an increase of 7.1% from total revenue of EUR 27.1 million (USD 29.5 million) for the same period in 2022.
Total revenue in the HIFU business for the six months ended June 30, 2023, was EUR 10.1 million (USD 11.0 million), an increase of 49.0% as compared to EUR 6.8 million (USD 7.4 million) for the six months ended June 30, 2022.
Total revenue in the LITHO business for the six months ended June 30, 2023, was EUR 5.0 million (USD 5.4 million), a decrease of 13.9% from EUR 5.8 million (USD 6.3 million) for the six months ended June 30, 2022.
Total revenue in the Distribution business for the six months ended June 30, 2023, was EUR 14.0 million (USD 15.1 million), a 4.1% decrease compared to EUR 14.6 million (USD 15.9 million) for the six months ended June 30, 2022.
Gross profit for the six months ended June 30, 2023, was EUR 11.7 million (USD 12.7 million), compared to EUR 12.0 million (USD 13.0 million), for the year-ago period. Gross profit margin on net sales was 40.2% for the six months ended June 30, 2023, compared to 44.0% for the comparable period in 2022. The decrease in gross profit margin year-over-year was primarily due to three main factors: Distribution product mix, global inflationary price pressure on components which increased manufacturing costs, and continued investments in our U.S. service and clinical application organizations to support HIFU and long-term revenue growth.
Operating expenses were EUR 22.5 million (USD 24.3 million) for the six months ended June 30, 2023, compared to EUR 12.5 million (USD 13.6 million) for the same period in 2022. The increase in operating expenses is mainly due to the strategic and planned build-out of the U.S. team and commercial infrastructure, and non-recurring expenses linked to the leadership succession plan.
Operating loss for the six months ended June 30, 2023, was EUR 10.8 million (USD 11.7 million), compared to an operating loss of EUR 0.5 million (USD 0.6 million) for the six months ended June 30, 2022.
Net loss for the six months ended June 30, 2023, was EUR 12.2 million (USD 13.2 million), or EUR 0.33 per diluted share, as compared to a net income of EUR 2.2 million (USD 2.4 million), or EUR 0.06 per diluted share in the year-ago period.
As of June 30, 2023, the Company held cash and cash equivalents of EUR 51.3 million (USD 56.0 million) as compared to EUR 63.1 million (USD 67.5 million) as of December 31, 2022.
Conference Call
A conference call and webcast to discuss second quarter 2023 financial results will be hosted Ryan Rhodes, Chief Executive Officer, François Dietsch, Chief Financial Officer and Ken Mobeck, Chief Financial Officer of the U.S. subsidiary, today, Thursday, August 24th, 2023 at 8:30am EDT. Please refer to the information below for conference call dial-in information and webcast registration.
Date: Thursday, August 24th @ 8:30am Eastern Time
Domestic: 1-877-451-6152
International: 1-201-389-0879
Passcode: 13740016
CallMe™: LINK (active 15 minutes prior to conference call)
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1624521&tp_key=5f05cd313e
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, us.hifu-prostate.com and www.focalone.com.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. 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 risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.
Other 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.
Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.
Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
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Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
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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, | June 30, | June 30, | June 30, | |||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Euros | Euros | $US | $US | |||||
| Sales of medical equipment | 9,804 | 9,684 | 10,657 | 10,245 | ||||
| Net Sales of RPP and Leases | 1,751 | 1,646 | 1,903 | 1,741 | ||||
| Sales of spare parts, supplies and Services | 2,724 | 2,820 | 2,961 | 2,984 | ||||
| TOTAL NET SALES | 14,278 | 14,151 | 15,522 | 14,969 | ||||
| Other revenues | — | — | — | — | ||||
| TOTAL REVENUES | 14,278 | 14,151 | 15,522 | 14,969 | ||||
| Cost of sales | (8,623) | (7,952) | (9,374) | (8,412) | ||||
| GROSS PROFIT | 5,655 | 6,198 | 6,148 | 6,557 | ||||
| Research & development expenses | (1,677) | (1,174) | (1,823) | (1,242) | ||||
| S, G & A expenses | (8,203) | (5,455) | (8,917) | (5,770) | ||||
| Total operating expenses | (9,880) | (6,629) | (10,740) | (7,012) | ||||
| OPERATING PROFIT (LOSS) | (4,225) | (430) | (4,592) | (455) | ||||
| Interest (expense) income, net | 255 | (29) | 278 | (31) | ||||
| Currency exchange gains (loss), net | (508) | 2,412 | (552) | 2,551 | ||||
| INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | (4,477) | 1,952 | (4,867) | 2,065 | ||||
| Income tax (expense) credit | (221) | (128) | (240) | (136) | ||||
| NET INCOME (LOSS) | (4,698) | 1,824 | (5,107) | 1,930 | ||||
| Earning per share – Basic | (0.13) | 0.05 | (0.14) | 0.06 | ||||
| Average number of shares used in computation of EPS | 36,985,934 | 33,469,053 | 36,985,934 | 33,469,053 | ||||
| Earning per share – Diluted | (0.13) | 0.05 | (0.14) | 0.06 | ||||
| Average number of shares used in computation of EPS for positive net income | 36,985,934 | 34,130,859 | 36,985,934 | 34,130,859 | ||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2023 average three months’ noon buying rate of 1 Euro = 1.0871 USD, and 2022 average three months noon buying rate of 1 Euro = 1.0579 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, | June 30, | June 30, | June 30, | |||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Euros | Euros | $US | $US | |||||
| Sales of medical equipment | 20,123 | 18,650 | 21,782 | 20,287 | ||||
| Net Sales of RPP and Leases | 3,329 | 2,963 | 3,604 | 3,223 | ||||
| Sales of spare parts, supplies and Services | 5,622 | 5,536 | 6,085 | 6,021 | ||||
| TOTAL NET SALES | 29,074 | 27,148 | 31,472 | 29,531 | ||||
| Other revenues | — | — | — | — | ||||
| TOTAL REVENUES | 29,074 | 27,148 | 31,472 | 29,531 | ||||
| Cost of sales | (17,387) | (15,190) | (18,821) | (16,524) | ||||
| GROSS PROFIT | 11,687 | 11,958 | 12,651 | 13,008 | ||||
| Research & development expenses | (3,135) | (2,255) | (3,393) | (2,453) | ||||
| S, G & A expenses | (19,333) | (10,242) | (20,928) | (11,141) | ||||
| Total operating expenses | (22,467) | (12,497) | (24,321) | (13,594) | ||||
| OPERATING PROFIT (LOSS) | (10,781) | (539) | (11,670) | (586) | ||||
| Interest (expense) income, net | 511 | (58) | 554 | (63) | ||||
| Currency exchange gains (loss), net | (1,653) | 2,981 | (1,789) | 3,243 | ||||
| INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST | (11,922) | 2,384 | (12,905) | 2,593 | ||||
| Income tax (expense) credit | (267) | (200) | (289) | (218) | ||||
| NET INCOME (LOSS) | (12,189) | 2,184 | (13,194) | 2,375 | ||||
| Earning per share – Basic | (0.33) | 0.07 | (0.36) | 0.07 | ||||
| Average number of shares used in computation of EPS | 36,954,439 | 33,467,594 | 36,954,439 | 33,467,594 | ||||
| Earning per share – Diluted | (0.33) | 0.06 | (0.36) | 0.07 | ||||
| Average number of shares used in computation of EPS for positive net income | 36,954,439 | 34,075,033 | 36,954,439 | 34,075,033 | ||||
NOTE: Translated for convenience of the reader to U.S. dollars at the 2023 average six months’ noon buying rate of 1 Euro = 1.0825 USD, and 2022 average six months noon buying rate of 1 Euro = 1.0878 USD
EDAP TMS S.A.
UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS
(Amounts in thousands of Euros and U.S. Dollars)
| June 30, | December 31, | June 30, | December 31, | |||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Euros | Euros | $US | $US | |||||
| Cash, cash equivalents and short-term treasury investments | 51,326 | 63,136 | 56,045 | 67,539 | ||||
| Account receivables, net | 18,020 | 14,943 | 19,677 | 15,985 | ||||
| Inventory | 13,310 | 11,780 | 14,534 | 12,601 | ||||
| Other current assets | 761 | 660 | 831 | 706 | ||||
| TOTAL CURRENT ASSETS | 83,417 | 90,518 | 91,086 | 96,832 | ||||
| Property, plant and equipment, net | 7,215 | 5,984 | 7,879 | 6,401 | ||||
| Goodwill | 2,412 | 2,412 | 2,634 | 2,580 | ||||
| Other non-current assets | 2,284 | 2,210 | 2,494 | 2,364 | ||||
| TOTAL ASSETS | 95,328 | 101,123 | 104,093 | 108,177 | ||||
| Accounts payable & other accrued liabilities | 16,761 | 13,087 | 18,302 | 14,000 | ||||
| Deferred revenues, current portion | 4,192 | 4,050 | 4,578 | 4,333 | ||||
| Short term borrowing | 1,610 | 1,846 | 1,758 | 1,975 | ||||
| Other current liabilities | 2,634 | 2,725 | 2,876 | 2,916 | ||||
| TOTAL CURRENT LIABILITIES | 25,197 | 21,708 | 27,514 | 23,223 | ||||
| Obligations under operating and finance leases non-current | 783 | 1,222 | 855 | 1,308 | ||||
| Long term debt, non-current | 2,769 | 3,587 | 3,024 | 3,837 | ||||
| Deferred revenues, non-current | 620 | 264 | 677 | 282 | ||||
| Other long term liabilities | 2,745 | 2,710 | 2,997 | 2,899 | ||||
| TOTAL LIABILITIES | 32,114 | 29,492 | 35,067 | 31,549 | ||||
| TOTAL SHAREHOLDERS’EQUITY | 63,214 | 71,632 | 69,026 | 76,628 | ||||
| TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY | 95,328 | 101,123 | 104,093 | 108,177 |
NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.0919 USD, on June 30, 2023 and at the noon buying rate of 1 Euro = 1.0697 USD, on December 31, 2022.
EDAP TMS S.A.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of Euros)
| Six Months Ended | Twelve Months Ended | Six Months Ended | Twelve Months Ended | |||||
| June 30, | December 31, | June 30, | December 31, | |||||
| 2023 | 2022 | 2023 | 2022 | |||||
| (Euros) | (Euros) | ($US) | ($US) | |||||
| NET INCOME (LOSS) | (12,189) | (2,933) | (13,194) | (3,085) | ||||
| Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1) | 5,165 | 4,225 | 5,591 | 4,444 | ||||
| OPERATING CASH FLOW | (7,024) | 1,292 | (7,603) | 1,359 | ||||
| Increase/Decrease in operating assets and liabilities | (1,668) | (4,316) | (1,806) | (4,539) | ||||
| NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES | (8,692) | (3,024) | (9,409) | (3,180) | ||||
| Short term investments (2) | (0) | — | (0) | — | ||||
| Additions to capitalized assets produced by the company and other capital expenditures | (2,653) | (2,378) | (2,872) | (2,501) | ||||
| NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES | (2,653) | (2,378) | (2,872) | (2,501) | ||||
| NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES | (836) | 21,741 | (905) | 22,869 | ||||
| NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | 372 | (388) | 1,692 | (3,053) | ||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (11,810) | 15,952 | (11,494) | 14,134 |
(1) including share based compensation expenses for 3,785 thousand of Euros for the six months ended June 30, 2023 and 2,103 thousand of Euros for the full year ended December 31, 2022.
NOTE: Translated for convenience of the reader to U.S. dollars at the 2023 average six months’ noon buying rate of 1 Euro = 1.0825 USD, and 2022 average twelve months noon buying rate of 1 Euro = 1.0519 USD
EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
six months ended June 30, 2023
(Amounts in thousands of Euros)
| HIFU | ESWL | Distribution | Reconciling | Total After | |||||||||||||||
| Division | Division | Division | Items | Consolidation | |||||||||||||||
| Sales of goods | 6,406 | 1,846 | 11,870 | — | 20,123 | ||||||||||||||
| Sales of RPPs & Leases | 2,670 | 517 | 143 | — | 3,329 | ||||||||||||||
| Sales of spare parts & services | 1,047 | 2,613 | 1,962 | — | 5,622 | ||||||||||||||
| TOTAL NET SALES | 10,122 | 4,976 | 13,975 | — | 29,074 | ||||||||||||||
| Other revenues | — | — | — | — | — | ||||||||||||||
| TOTAL REVENUES | 10,122 | 4,976 | 13,975 | — | 29,074 | ||||||||||||||
| GROSS PROFIT (% of Net Sales) | 5,247 | 51.8 | % | 1,971 | 39.6 | % | 4,469 | 32.0 | % | — | 11,687 | 40.2 | % | ||||||
| Research & Development | (2,559) | (351) | (224) | — | (3,135) | ||||||||||||||
| Total SG&A plus depreciation | (9,055) | (1,857) | (5,186) | (3,235) | (19,333) | ||||||||||||||
| OPERATING PROFIT (LOSS) | (6,367) | (238) | (941) | (3,235) | (10,781) |
| Last Trade: | US$2.45 |
| Daily Volume: | 0 |
| Market Cap: | US$90.900M |
November 07, 2024 October 01, 2024 September 19, 2024 August 28, 2024 | |
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