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01/11 18:38
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reflects strong growth in the core HIFU business, with record revenue and significant increases in HIFU revenue and placements. The strategic financing with EIB and the new CPT code for BPH treatment are positive developments. Although there are concerns about the declining noncore business and operating losses, the optimistic guidance and strategic investments in HIFU suggest a positive outlook. The Q&A session confirmed positive trends in U.S. procedures and payer coverage. Overall, these factors indicate a likely positive stock price movement.
Global Revenue USD 16.1 million, marking the second consecutive quarter with record overall quarterly revenue for the respective period.
HIFU Revenue USD 7.7 million, representing a 57% increase compared to the third quarter of last year. This growth reflects consistent commercial execution, expanding clinical adoption, and growing recognition of the value Focal One Robotic HIFU brings to patients, physicians, and hospitals.
Focal One Placements 8 placements (6 capital sales and 2 operating leases), representing growth of 167% compared to the same period 1 year ago. This reflects growing confidence hospitals have in adopting Focal One Robotic HIFU as an integral cornerstone of their prostate cancer program.
Focal One Procedures in the U.S. Grew more than 15% year-over-year, reflecting growing clinical adoption of Focal One combined with the impact of sustained investment in market access initiatives.
Total Revenue (EUR) EUR 13.9 million, an increase of 6% compared to EUR 13.1 million for the same period in 2024.
Total HIFU Revenue (EUR) EUR 6.7 million, a 49% year-over-year increase compared to EUR 4.5 million for the third quarter of 2024. This was driven by 6 Focal One capital sales versus 3 in the prior year period and a 26% year-over-year increase in Focal One treatment-driven revenue.
Gross Profit (EUR) EUR 6 million, compared to EUR 5.2 million for the same period a year ago. Gross margin increased to 43% from 39.4% year-over-year, primarily due to the strategic shift to the high-margin HIFU business segment.
Operating Expenses (EUR) EUR 10.9 million, compared to EUR 11 million for the same period in 2024.
Operating Loss (EUR) EUR 4.9 million, approximately EUR 1 million lower compared to EUR 5.8 million in the third quarter of 2024.
Net Loss (EUR) EUR 5 million or EUR 0.13 per share, a EUR 1.4 million improvement compared to a net loss of EUR 6.4 million or EUR 0.17 per share in the same period a year ago.
Inventory (EUR) Decreased to EUR 13.8 million in Q3 compared to EUR 15.5 million in the prior quarter, due to continued efforts and focus on just-in-time inventory management.
Cash and Cash Equivalents (EUR) EUR 10.6 million at the end of Q3 2025, compared to EUR 16.3 million in the prior quarter. The sequential decrease was driven primarily by cash used in operating activities to support strategic investments in HIFU.
Focal One Robotic HIFU: Achieved record HIFU revenue of USD 7.7 million in Q3 2025, a 57% increase YoY. Placed 8 Focal One units, including 6 capital sales and 2 operating leases, marking a 167% growth YoY. Integrated into 21 of 35 SUO-approved fellowship programs, representing 60% of such centers nationwide.
Endometriosis Treatment: Phase III RCT data showed significant symptom improvement at 3 months, maintained at 1 year. Over 85% of sham group patients opted for HIFU post-unblinding, reporting significant symptom improvement. Limited commercial launch in Europe underway.
Market Access and Reimbursement: Achieved meaningful progress in reimbursement coverage, particularly with Medicare Advantage providers, driving broader patient access and stronger hospital economics.
Expansion into BPH Treatment: Progressing Phase I/II study in Europe and received IRB approval for U.S. study in partnership with Mount Sinai. First patient enrollment expected by year-end.
Revenue Growth: Global revenue reached USD 16.1 million in Q3 2025, marking the second consecutive quarter of record revenue. HIFU business revenue grew 49% YoY, offsetting declines in noncore businesses.
Operational Efficiencies: Improved manufacturing efficiencies, optimized supply chain, and transitioned to a new ultrasound imaging scanner supplier to reduce costs in the upcoming year.
Strategic Focus on HIFU: Shifted focus to high-margin HIFU business, contributing to increased gross margins (43% in Q3 2025 vs. 39.4% in Q3 2024).
Recognition and Awards: Focal One received the 2025 Industry Award for innovations in Endourological Instrumentation at the WCET meeting.
Tariff Impact: The company is forecasting a 15% tariff impact for all goods transferred between France and the U.S., with a year-to-date impact of approximately EUR 300,000 and an estimated full-year impact of EUR 900,000. This could affect profitability and operational costs.
Cash and Cash Equivalents: Total cash and cash equivalents decreased to EUR 10.6 million at the end of Q3 2025 from EUR 16.3 million in the prior quarter, primarily due to cash used in operating activities to support strategic investments in HIFU. This reduction in liquidity could constrain future investments or operational flexibility.
Decline in Noncore Businesses: Revenue from noncore distribution and ESWL businesses declined by 16% in Q3 2025 compared to Q3 2024, and is expected to decline by 25% to 30% year-over-year. This ongoing decline could impact overall revenue diversification and stability.
Operating Loss: The company reported an operating loss of EUR 4.9 million for Q3 2025, which, while an improvement from the prior year, still represents a significant financial challenge.
Inventory Management: Inventory decreased to EUR 13.8 million in Q3 2025 from EUR 15.5 million in the prior quarter due to just-in-time inventory management. While this improves efficiency, it could pose risks if demand unexpectedly spikes.
Supplier Transition: The company is transitioning to a new supplier for its ultrasound imaging scanner, which is expected to reduce costs in the upcoming calendar year. However, this transition could pose short-term risks to supply chain stability and product availability.
Core HIFU Business Revenue Growth: Expected to grow within the range of 26% to 34% year-over-year in 2025.
Noncore ESWL and Distribution Business Revenue Decline: Expected to decline within the range of 25% to 30% year-over-year in 2025.
U.S. Procedure Growth: Return to double-digit growth in Focal One procedures in the U.S. is expected to continue.
Market Access and Reimbursement Coverage: Continued expansion in market access and reimbursement coverage, particularly among Medicare Advantage providers, is anticipated to drive broader patient access and stronger hospital economics.
BPH Clinical Development Program: Progressing with a Phase I/II multicenter study in Europe and a U.S. clinical study in partnership with the Icahn School of Medicine at Mount Sinai. The first patient enrollment in the U.S. study is expected before the end of 2025.
Endometriosis Treatment Expansion: Actively working with leading European centers in a limited launch phase to establish a foundation for expanded adoption of Focal One HIFU as a noninvasive treatment option for deep infiltrating endometriosis.
Cost Reduction Impact: Transition to a new supplier for ultrasound imaging scanners is expected to result in cost reductions in the upcoming calendar year.
The selected topic was not discussed during the call.
The earnings call reflects strong growth in the core HIFU business, with record revenue and significant increases in HIFU revenue and placements. The strategic financing with EIB and the new CPT code for BPH treatment are positive developments. Although there are concerns about the declining noncore business and operating losses, the optimistic guidance and strategic investments in HIFU suggest a positive outlook. The Q&A session confirmed positive trends in U.S. procedures and payer coverage. Overall, these factors indicate a likely positive stock price movement.
The earnings call reveals strong financial performance with a 76.8% increase in HIFU revenue and improved gross margins. Despite operating and net losses, strategic investments in HIFU and efficient inventory management are promising. Positive Q&A insights include efforts to improve reimbursement, growing demand, and multiunit purchases, indicating confidence in future growth. However, some concerns remain about reimbursement and unclear management responses. Overall, the company's strategic focus and optimistic guidance point to a positive stock price movement.
The earnings call reveals a challenging financial performance with increased net losses and declining non-core revenues. Despite positive HIFU growth, the lack of shareholder returns and competitive pressures weigh heavily. Regulatory issues and economic factors like tariffs add to the uncertainty. While there is optimism in HIFU revenue guidance, the Q&A highlighted unclear management responses on payer challenges. The absence of a share buyback or dividend increase further dampens sentiment. Overall, the factors suggest a negative market reaction over the next two weeks.
The earnings call reveals several negative factors: a decline in total revenue, increased operational losses, and financial instability due to the strategic shift to HIFU. Despite a moderate growth forecast for HIFU, the challenges in payer landscape, increased tariffs, and a lack of clear management responses contribute to uncertainty. The absence of a share buyback program and declining cash reserves further weigh negatively. Although optimistic guidance for HIFU exists, the overall sentiment is negative, especially with the negative trend in non-core businesses and operational losses.
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