EDAP TMS(US:EDAP)2022-05-18 16:54Financial 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]