EDAP Reports Third Quarter 2022 Results
EDAP reported strong Q3 2022 results with total revenue of approximately EUR 12.2 million (USD 12.3 million), a 29.7% increase from EUR 9.4 million (USD 11.1 million) in Q3 2021. Year-to-date revenue rose 30.9% to EUR 39.4 million (USD 41.7 million). HIFU sales surged 81% year-over-year, contributing EUR 3.5 million (USD 3.5 million) in Q3. The company ended the quarter with a cash position of EUR 68.3 million (USD 66.8 million).
The U.S. CMS increased reimbursement for HIFU prostate ablation, boosting potential hospital revenue by over 90%.
- Total revenue for Q3 2022 increased by 29.7% to EUR 12.2 million (USD 12.3 million).
- HIFU sales grew by 81% to EUR 3.5 million (USD 3.5 million) in Q3 2022.
- Year-to-date revenue rose by 30.9% to EUR 39.4 million (USD 41.7 million).
- The gross profit margin improved to 43.1% for the nine months ended September 30, 2022.
- Strong cash position of EUR 68.3 million (USD 66.8 million) as of September 30, 2022.
- Increased reimbursement for HIFU ablation expected to enhance hospital investment.
- Operating loss increased to EUR 2.7 million (USD 2.8 million) for the nine months ended September 30, 2022.
- Operating expenses rose significantly to EUR 19.7 million (USD 20.8 million) for the nine months ended September 30, 2022.
- 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 of81% 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
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
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
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
Total revenue in the Distribution business for the nine months ended September 30, 2022, was EUR 21.2 million (USD 22.4 million), a
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
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
Total revenue in the HIFU business for the third quarter 2022 was EUR 3.5 million (USD 3.5 million), an increase of
Total revenue in the LITHO business for the third quarter 2022 was EUR 2.2 million (USD 2.2 million), a decrease of
Total revenue in the Distribution business for the third quarter 2022 was EUR 6.6 million (USD 6.6 million), a
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
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
FAQ
What were EDAP's total revenues for Q3 2022?
How did HIFU sales perform in Q3 2022?
What is the latest cash position of EDAP?
What impact does the CMS reimbursement increase have for EDAP?
What were the operating expenses for EDAP in Q3 2022?
