Workflow
EDAP TMS(EDAP)
icon
Search documents
EDAP TMS(EDAP) - 2023 Q1 - Quarterly Report
2023-03-29 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 March 30, 2023 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ x] Form 40-F [ ] SIGNATURES Pursuant to the ...
EDAP TMS(EDAP) - 2022 Q3 - Earnings Call Transcript
2022-11-17 18:54
EDAP TMS S.A. (NASDAQ:EDAP) Q3 2022 Earnings Conference Call November 17, 2022 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors, IR Marc Oczachowski - CEO and Chairman of the Board of Directors Ryan Rhodes - CEO, EDAP US Francois Dietsch - CFO Conference Call Participants Michael Sarcone - Jefferies Jason Bednar - Piper Sandler Frank Takkinen - Lake Street Capital Markets Sean Lee - H.C. Wainwright Operator Greetings and welcome to EDAP TMS Third Quarter 2022 Earnings Call. At this time, all ...
EDAP TMS(EDAP) - 2022 Q3 - Quarterly Report
2022-11-15 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 November 16, 2022 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [x] Form 40-F [ ] Indicate by check mark i ...
EDAP TMS(EDAP) - 2022 Q2 - Earnings Call Transcript
2022-08-25 14:32
EDAP TMS S.A. (NASDAQ:EDAP) Q2 2022 Earnings Conference Call August 25, 2022 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors, IR Marc Oczachowski - CEO & Chairman of the Board of Directors Ryan Rhodes - CEO, EDAP US Francois Dietsch - CFO Conference Call Participants Frank Takkinen - Lake Street Capital Jason Bednar - Piper Sandler Swayampakula Ramakanth - H.C. Wainwright Operator Greetings. Welcome to EDAP TMS Second Quarter 2022 Earnings Conference Call. At this time, all participants are ...
EDAP TMS(EDAP) - 2022 Q2 - Quarterly Report
2022-08-23 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 August 24, 2022 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ x] Form 40-F [ ] Indicate by check mark if ...
EDAP TMS(EDAP) - 2022 Q1 - Earnings Call Transcript
2022-05-18 16:54
Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was EUR 13 million (approximately $14.5 million), a 26% increase from EUR 10.3 million (approximately $12.4 million) in Q1 2021 [5][12] - Gross profit for Q1 2022 was EUR 5.8 million, compared to EUR 4.4 million in the same period last year, with a gross profit margin of 44.3% in Q1 2022 versus 42.4% in Q1 2021 [15] - Operating loss for Q1 2022 was EUR 0.1 million, compared to an operating profit of EUR 0.2 million in Q1 2021; excluding non-cash share-based compensation, operating profit would have been EUR 2.5 million [16] Business Line Data and Key Metrics Changes - Revenue in the HIFU business for Q1 2022 was EUR 3.8 million, a 112% increase from EUR 1.8 million in Q1 2021; four Focal One Robotic HIFU units were sold in Q1 2022 compared to zero in the prior year [13] - Revenue in the LITHO business for Q1 2022 was EUR 2.2 million, down from EUR 2.9 million in Q1 2021, with one lithotripsy device sold compared to six in the previous year [14] - Revenue in the Distribution business for Q1 2022 was EUR 7 million, a 24% increase from EUR 5.6 million in Q1 2021, driven by nine ExactVu units sold compared to five in the prior year [14] Market Data and Key Metrics Changes - The US market showed strong performance with three Focal One machines sold to prestigious academic and integrated health network reference centers [8] - The sales pipeline continues to grow, with increasing interest from both academic centers and community hospitals, indicating a shift towards broader acceptance of focal therapy [20][21] Company Strategy and Development Direction - The company is focused on expanding its HIFU technology into clinical applications beyond prostate cancer, including a Phase II study for treating deep infiltrating endometriosis [6][7] - The management is optimistic about the growth potential in the US market, emphasizing the importance of building a strong sales team and infrastructure [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong start to 2022, with expectations for continued growth in capital placements and treatment volumes [18] - The company is actively engaging with CMS regarding reimbursement levels, with a guarded optimism about potential upgrades to APC level 6 [25] Other Important Information - As of March 31, 2022, the company held cash and cash equivalents of EUR 46.4 million (approximately $51.6 million), down slightly from EUR 47.2 million (approximately $53.4 million) at the end of 2021 [17] Q&A Session Summary Question: Can you speak to the growth in the dollar value of the funnel and the mix between community and academic hospitals? - The company has a strong pipeline with added interest from both academic centers and community hospitals, indicating a balanced mix [20][21] Question: What are the seasonality expectations for 2022? - Historically, Q1 is not the weakest quarter; Q3 typically sees a slowdown, with Q4 being the strongest [23] Question: Any updates on CMS conversations regarding APC level 6 eligibility? - The company remains cautiously optimistic about the potential upgrade to APC level 6, with a proposal expected in July [25] Question: How should investors think about the growth of OpEx in relation to top-line growth? - Operating expenses are expected to increase as the company builds its US team and infrastructure [28] Question: Can you comment on the time from lead to final purchase for Focal One? - The sales cycle can vary, but the company is seeing shorter cycle times as the sales team becomes more established [33] Question: What is the current trend in procedure volume? - The company continues to see sequential growth and double-digit growth quarter-over-quarter in procedure volumes [35] Question: Are there plans to explore other indications beyond endometriosis? - The company is exploring additional indications, including BPH treatment and pancreatic cancer, as part of its long-term vision [36]
EDAP TMS(EDAP) - 2021 Q4 - Annual Report
2022-04-07 16:00
Table of Contents As filed with the Securities and Exchange Commission on April 8, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR (G) OF THE SECURITIES EXCHANGE ACT OF 1934, OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transiti ...
EDAP TMS(EDAP) - 2022 Q1 - Quarterly Report
2022-03-29 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 March 30, 2022 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ x] Form 40-F [ ] Indicate by check mark if ...
EDAP TMS(EDAP) - 2021 Q3 - Earnings Call Transcript
2021-11-18 15:18
Financial Data and Key Metrics Changes - Year-to-date revenue for the nine months ended September 30th was €30.1 million, or $35.9 million, representing growth of 14.4% over the first nine months of 2020 [6] - Total company revenue for the third quarter was €9.4 million or $11.1 million, essentially flat compared to the year-ago period [7] - Gross profit for the third quarter of 2021 was €3.6 million, compared to €4 million for the year-ago period, with a gross profit margin of 38.4% [34] - Operating loss for the third quarter of 2021 was €1.9 million, compared to an operating loss of €0.3 million in the third quarter of 2020 [36] - Net loss for the third quarter of 2021 was €1 million or €0.03 per diluted share, consistent with the net loss of €1 million, or €0.03 per diluted share in the year-ago period [36] Business Line Data and Key Metrics Changes - Total revenue in the HIFU business for the third quarter of 2021 was €1.9 million, a decline of 25.6% compared to €2.6 million for the third quarter of 2020 [32] - Total revenue in the LITHO business for the third quarter of 2021 was €2.5 million, an increase of about 3% versus the third quarter of 2020 [33] - Total revenue in the Distribution business for the third quarter of 2021 was €5 million, a 13.4% increase compared to €4.4 million for the third quarter of 2020 [33] Market Data and Key Metrics Changes - US treatment volumes are up 68% over the same period in 2020, indicating growing adoption of Focal One HIFU as a prostate cancer treatment alternative [10] - The growth in US treatment volumes reflects the positive impact of HIFU category one CPT reimbursement code that went into effect on January 1 of this year [12] Company Strategy and Development Direction - The company is focused on increasing its US pipeline and establishing HIFU and the robotic Focal One device as the leading therapeutic tool in ablating prostate tissue [38] - A comprehensive action plan has been developed to demonstrate to CMS the benefits of HIFU technology, with the aim of securing increased facility reimbursement to level 6 starting in 2023 [14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that delays in machine placements were due to COVID-related restrictions, but expressed optimism about recognizing equipment sales in Q4 [8] - The company remains confident in its ability to navigate the challenging hospital CapEx environment and is optimistic about future sales and key placements [38] Other Important Information - The company held cash and cash equivalents of €45.4 million, or US$52.6 million, as of September 30, 2021, compared to €24.7 million, or US$30.2 million at the end of December 2020 [36] - The company is actively recruiting for its US commercial organization to enhance sales efforts [46] Q&A Session Summary Question: Sales funnel and penetration into Tier 1 accounts - Management indicated that discussions with Tier 1 hospitals are increasing, and more placements are expected in the near term [42] Question: Investment in the commercial organization - The company has added notable hires and is actively recruiting more skilled individuals to expand its sales personnel [46] Question: Reimbursement levels and expectations - Management discussed the potential for moving to APC level 6 reimbursement in 2023 based on improved treatment volumes and claims data [47][75] Question: Leading indicators of demand - Management noted that the addition of headcount and support for existing customers are contributing to a positive outlook for demand [52] Question: Challenges in the marketplace - Management stated that they are navigating supply chain challenges effectively and remain optimistic about improving gross margins [54] Question: Feedback from physicians and clinical data - Management highlighted the strength of clinical data supporting HIFU and its efficacy compared to traditional surgery [67]
EDAP TMS(EDAP) - 2021 Q3 - Quarterly Report
2021-11-16 16:00
[Financial Performance and Operational Update](index=3&type=section&id=Financial%20Performance%20and%20Operational%20Update) [Management Commentary and Operational Highlights](index=3&type=section&id=Management%20Commentary%20and%20Operational%20Highlights) Management reported a **58% year-to-date** increase in U.S. HIFU treatment volumes, with Q3 revenue flat due to pandemic-related capital spending and logistical delays, while maintaining a strong EUR 45.4 million cash position - U.S. HIFU treatment volumes increased by **58% year-to-date**, indicating strong adoption of Focal One therapy[7](index=7&type=chunk)[8](index=8&type=chunk) - Third-quarter revenue was impacted by the COVID-19 pandemic's effect on hospital capital spending and logistical delays[7](index=7&type=chunk)[8](index=8&type=chunk) - The company maintains a strong cash position of **EUR 45.4 million (USD 52.6 million)**[7](index=7&type=chunk)[18](index=18&type=chunk) [Nine Months 2021 Financial Results](index=3&type=section&id=Nine%20Months%202021%20Financial%20Results) Nine-month 2021 total revenue grew **14.4% to EUR 30.1 million**, driven by Distribution, despite declines in HIFU and LITHO, with net loss narrowing to EUR 0.7 million Nine Months 2021 Key Financials (vs. 9M 2020) | Metric | 9M 2021 (EUR Million) | 9M 2020 (EUR Million) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | 30.1 | 26.3 | +14.4% | | Gross Profit | 12.2 | 11.4 | +7.0% | | Operating Loss | (2.1) | (1.5) | Widened | | Net Loss | (0.7) | (2.5) | Narrowed | | Diluted EPS (EUR) | (0.02) | (0.09) | Improved | Nine Months 2021 Revenue by Business (vs. 9M 2020) | Business Segment | 9M 2021 Revenue (EUR Million) | 9M 2020 Revenue (EUR Million) | YoY Change | | :--- | :--- | :--- | :--- | | Distribution | 16.7 | 11.0 | +52.4% | | LITHO | 7.7 | 8.3 | -7.4% | | HIFU | 5.7 | 7.1 | -18.9% | [Third Quarter 2021 Financial Results](index=4&type=section&id=Third%20Quarter%202021%20Financial%20Results) Q3 2021 total revenue was flat at EUR 9.4 million, with Distribution and LITHO growth offset by a **25.6% decline in HIFU**, leading to a widened operating loss of EUR 1.9 million Third Quarter 2021 Key Financials (vs. Q3 2020) | Metric | Q3 2021 (EUR Million) | Q3 2020 (EUR Million) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | 9.4 | 9.4 | Flat | | Gross Profit | 3.6 | 4.0 | -10.0% | | Operating Loss | (1.9) | (0.3) | Widened | | Net Loss | (1.0) | (1.0) | Flat | | Diluted EPS (EUR) | (0.03) | (0.03) | Flat | Third Quarter 2021 Revenue by Business (vs. Q3 2020) | Business Segment | Q3 2021 Revenue (EUR Million) | Q3 2020 Revenue (EUR Million) | YoY Change | | :--- | :--- | :--- | :--- | | Distribution | 5.0 | 4.4 | +13.4% | | LITHO | 2.5 | 2.4 | +3.0% | | HIFU | 1.9 | 2.6 | -25.6% | [Unaudited Condensed Consolidated Financial Statements](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Consolidated operations show Q3 2021 revenues flat at EUR 9.44 million with increased operating loss, while nine-month revenues rose to EUR 30.09 million and net loss significantly narrowed to EUR 0.67 million Q3 2021 Statement of Operations Highlights (in thousands of Euros) | Line Item | Q3 2021 | Q3 2020 | | :--- | :--- | :--- | | TOTAL REVENUES | 9,440 | 9,433 | | GROSS PROFIT | 3,625 | 3,964 | | S, G & A expenses | (4,446) | (3,167) | | OPERATING PROFIT (LOSS) | (1,885) | (293) | | NET INCOME (LOSS) | (1,015) | (1,001) | Nine Months 2021 Statement of Operations Highlights (in thousands of Euros) | Line Item | 9M 2021 | 9M 2020 | | :--- | :--- | :--- | | TOTAL REVENUES | 30,092 | 26,298 | | GROSS PROFIT | 12,211 | 11,350 | | OPERATING PROFIT (LOSS) | (2,073) | (1,451) | | NET INCOME (LOSS) | (665) | (2,484) | [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) As of September 30, 2021, the balance sheet strengthened with cash doubling to EUR 45.4 million, total assets increasing to EUR 73.7 million, and shareholders' equity rising to EUR 48.0 million Balance Sheet Highlights (in thousands of Euros) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | 45,411 | 24,696 | | TOTAL CURRENT ASSETS | 64,672 | 45,393 | | TOTAL LIABILITIES | 25,646 | 28,945 | | TOTAL SHAREHOLDERS' EQUITY | 48,040 | 26,248 | [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2021, operating activities generated EUR 1.8 million cash, with financing activities providing EUR 20.4 million, resulting in a net cash increase of EUR 20.7 million Nine Months 2021 Cash Flow Summary (in thousands of Euros) | Cash Flow From | 9M 2021 Amount | | :--- | :--- | | Operating Activities | 1,774 | | Investing Activities | (988) | | Financing Activities | 20,384 | | **Net Increase in Cash** | **20,716** | [Statements of Operations by Division](index=10&type=section&id=Statements%20of%20Operations%20by%20Division) For the first nine months of 2021, Distribution was the primary driver with EUR 16.7 million revenue and EUR 2.1 million operating profit, while HIFU recorded an operating loss of EUR 3.3 million Nine Months 2021 Performance by Division (in thousands of Euros) | Division | Total Revenues | Gross Profit | Operating Profit (Loss) | | :--- | :--- | :--- | :--- | | HIFU | 5,717 | 2,150 | (3,269) | | ESWL | 7,667 | 3,526 | 585 | | Distribution | 16,708 | 6,536 | 2,067 |