-
EDAP Reports Third Quarter 2022 Results
来源: Nasdaq GlobeNewswire / 16 11月 2022 16:35:00 America/New_York
- 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: HereFollowing 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.comInvestor Contact
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.comEDAP 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