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Bloomberg· 2026-02-19 04:28
Washington Mayor Muriel Bowser declares an emergency over the massive sewage spill in the Potomac River and asks Trump for a disaster declaration and reimbursement for costs incurred by the District of Columbia https://t.co/Zbqk8RyhpQ ...
AVITA Medical(RCEL) - 2025 Q4 - Earnings Call Transcript
2026-02-12 22:32
Financial Data and Key Metrics Changes - The company reported fourth quarter revenue of $17.6 million and full-year revenue of approximately $71.6 million, representing about 11% growth over 2024 [5][11] - Full year gross margin was 82.1%, down from 85.8% in 2024, reflecting inventory reserves and product mix changes [12] - Fourth quarter gross margin was 81.2%, compared to 87.6% for the same period last year [13] Business Line Data and Key Metrics Changes - Approximately 90% of revenue comes from about 200 burn and trauma centers, with a focus on increasing adoption and utilization of products like RECELL, Cohealyx, and PermeaDerm [6][7] - The Cohealyx I post-market study is fully enrolled, and the PermeaDerm I study is nearing full enrollment, with data expected later in 2026 [8] Market Data and Key Metrics Changes - Six of the seven Medicare administrative contractors have published payment rates for RECELL procedures, which is expected to restore confidence among clinicians [6] - The company is taking a disciplined distributor-led approach in select international markets, focusing on establishing operational readiness [9] Company Strategy and Development Direction - The company aims to drive disciplined execution, refine commercial focus, and position for growth in 2026, with a strategy centered around an integrated platform of products [4][10] - The company expects full year revenue of $80 million to $85 million in 2026, representing growth of approximately 12% to 19% over 2025 [10] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of predictable reimbursement for products and the need for increased adoption and utilization by clinicians [6][18] - The company is focused on maintaining disciplined control of operating costs and supporting revenue growth with a stable cost structure [17] Other Important Information - The company refinanced its debt through a new credit facility, which provides more flexibility and reduces covenant risk [15][16] - The fourth quarter marked the third consecutive quarter of improvement in net cash use, declining from $10.1 million in Q2 to $5.1 million in Q4 [15] Q&A Session Summary Question: Guidance on revenue covenants and growth pace - Management clarified that the $15.4 million covenant is not a guidance figure and that they expect growth to continue from Q4 into Q1 and throughout the year [20][21] Question: Reimbursement dynamics affecting 2025 - Management confirmed engagement with all seven MACs and expressed optimism about the seventh MAC publishing payment rates soon [30][31] Question: Customer experience with Cohealyx and PermeaDerm - Management discussed the process of working with champions in accounts to facilitate the adoption of Cohealyx and PermeaDerm, noting early positive experiences [37][38] Question: Drivers of growth for 2026 guidance - Management indicated that growth will come from increased utilization within existing accounts and contributions from Cohealyx and PermeaDerm [49]
AVITA Medical(RCEL) - 2025 Q4 - Earnings Call Transcript
2026-02-12 22:30
Financial Data and Key Metrics Changes - The company reported fourth quarter revenue of $17.6 million and full-year revenue of approximately $71.6 million, representing about 11% growth over 2024 [5][12] - Full year gross margin was 82.1%, down from 85.8% in 2024, reflecting inventory reserves and product mix changes [12] - Fourth quarter gross margin was 81.2%, compared to 87.6% for the same period last year [13] - Total operating expenses in the fourth quarter were $24.7 million, down 5% year-over-year, primarily due to lower sales and marketing expenses [14] Business Line Data and Key Metrics Changes - The company focused on increasing adoption and utilization of its products, with approximately 90% of revenue coming from about 200 burn and trauma centers [6][8] - The Cohealyx I post-market study is fully enrolled, and the PermeaDerm I study is nearing full enrollment, with data expected later in 2026 [9] Market Data and Key Metrics Changes - Six of the seven Medicare administrative contractors have published payment rates for RECELL procedures, which has begun to restore confidence for clinicians [6] - The company is taking a disciplined distributor-led approach to build its footprint in select international markets [10] Company Strategy and Development Direction - The company aims to drive disciplined execution, refine commercial focus, and position itself for growth in 2026 [4] - The strategy is built around a single integrated platform of RECELL, Cohealyx, and PermeaDerm, used repeatedly by the same clinicians [8] - The company expects full year revenue of $80 million-$85 million in 2026, representing growth of approximately 12%-19% over 2025 [11] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of predictable reimbursement for products and clinicians to drive routine use of RECELL [6] - The company is focused on establishing the right operating cadence and executing fundamentals well to ensure consistent progress [8] - Management expressed confidence in the normalization of RECELL utilization and the expansion of portfolio use within core accounts [11] Other Important Information - The company refinanced its debt through a new credit facility, which provides more flexibility and reduces covenant risk [15][16] - The fourth quarter marked the third consecutive quarter of improvement in net cash use, declining to $5.1 million [15] Q&A Session Summary Question: Guidance on revenue growth pace - Management clarified that the $15.4 million revenue covenant is not a guidance figure and that they expect progressive growth from Q4 to Q1 and throughout the year [22][26] Question: Reimbursement dynamics affecting 2025 - Management confirmed that they are engaged with all seven MACs and are hopeful for the seventh MAC to publish payment rates soon [30][31] Question: Customer experience with Cohealyx and PermeaDerm - Management indicated that champions in accounts are helping to push Cohealyx and PermeaDerm through the VAC process, with early signs of uptake [37][38] Question: Drivers of growth for 2026 guidance - Management expects growth from all three product lines, primarily driven by increased utilization within existing accounts [48]
Inspire Medical Systems, Inc. Announces Preliminary Unaudited Revenue Results for the Fourth Quarter and Full Year 2025 and Provides Initial 2026 Revenue Guidance
Globenewswire· 2026-01-12 11:45
Core Insights - Inspire Medical Systems announced the appointment of Matt Osberg as Executive Vice President and Chief Financial Officer, effective January 19, 2026 [3][4] - The company provided preliminary, unaudited revenue results for the fourth quarter and full year 2025, with fourth quarter revenue expected to be between $268.9 million and $269.1 million, representing a 12% increase year-over-year [6] - For the full year 2025, revenue is anticipated to be in the range of $911.8 million to $912.0 million, marking a 14% increase compared to 2024 [6] - Inspire's revenue guidance for 2026 is projected to be between $1,003 million and $1,013 million, indicating a growth of 10% to 11% over 2025 [2] Financial Performance - The fourth quarter revenue for 2025 is expected to show a strong performance, contributing to the overall positive momentum for the company [2] - The company experienced significant growth in the second half of 2025, particularly following the launch of the Inspire V system [2] - Inspire's revenue growth outlook for 2026 does not currently factor in potential increases from reimbursement developments [2] Leadership Changes - Matt Osberg brings over 20 years of financial leadership experience to Inspire, having previously served as CFO at Apogee Enterprises and Helen of Troy [3][4] - The appointment of Osberg is seen as a strategic move to guide the company through its next growth phase [4] Company Overview - Inspire Medical Systems focuses on developing and commercializing innovative, minimally invasive solutions for obstructive sleep apnea [8] - The company's Inspire therapy is recognized as the first FDA, EU MDR, and PDMA-approved neurostimulation technology for treating moderate to severe obstructive sleep apnea [8]
Here's Why You Should Retain INSP Stock in Your Portfolio Now
ZACKS· 2025-12-22 13:56
Core Insights - Inspire Medical Systems (INSP) is positioned for growth due to a significant product transition, with management highlighting clinical momentum, improved reimbursement visibility, and disciplined cost control, despite facing near-term challenges related to inventory conversion and competition [2][12][14] Company Overview - Inspire Medical focuses on innovative, minimally-invasive solutions for obstructive sleep apnea, with a market capitalization of $2.81 billion. The company anticipates a 39.1% earnings decline for Q4 2025, but expects earnings growth to resume in 2026 [4] Financial Performance - INSP shares have decreased by 12.5% over the past six months, while the industry has declined by 16.3%, and the S&P 500 has increased by 16.3% during the same period [3] - The company has consistently surpassed earnings estimates in the last four quarters, achieving an average surprise of 164.19% [6] Positive Factors Driving Prospects - The launch of Inspire V is a key growth driver, with strong clinical data supporting its adoption, including reduced surgical times and high nightly usage. Adoption has accelerated, reaching over 75% of implanting centers [7] - Reimbursement trends are favorable, with an 11% increase in the physician fee schedule for CPT 64568 effective January 2026, enhancing the economic viability for hospitals [8][9] - The adoption of GLP-1 therapies is increasing patient flow into sleep clinics, which could lead to more referrals for Inspire Medical as noncompliance with CPAP emerges [10] Operational Discipline - The company has demonstrated operational discipline, achieving earnings upside through gross margin expansion and cost control, despite increased marketing expenses [11] Key Challenges - The transition from Inspire IV to Inspire V presents complexities, with some centers continuing to use Inspire IV for economic reasons, which complicates inventory forecasting [12] - Uncertainty exists around GLP-1 trialing, which may delay surgical interventions and impact short-term volume growth [13] - Elevated operating expenses and competition pose challenges to maintaining margin expansion, as operating expenses growth outpaces revenue growth [14] Estimate Trend - The Zacks Consensus Estimate for earnings in 2025 is $1.71 per share, with Q4 2025 revenue estimated at $262.9 million and a loss per share of 70 cents [15]
The Pennant Group (NasdaqGS:PNTG) FY Conference Transcript
2025-11-19 21:02
Summary of The Pennant Group FY Conference Call Company Overview - **Company**: The Pennant Group (NasdaqGS:PNTG) - **Industry**: Home health and hospice services, senior living facilities Key Points and Arguments 1. Growth and Acquisitions - The Pennant Group had a productive year in 2025, starting with the second tranche of the Signature acquisition and culminating in the purchase of a large portfolio from UnitedHealth and Amedisys [25][26] - The company emphasizes investment in leadership, which has led to organic growth in operations, surpassing previous performance levels [27][28] 2. Integration Process - The integration of new acquisitions involves a structured approach focusing on leadership readiness, operational health, and the opportunity presented by the acquisition [31][32] - A typical optimization process post-acquisition spans about nine quarters, involving technology integration and rebranding efforts [33][34] 3. Financial Management - The company expects G&A costs to normalize from approximately 6.7% to 6.5% by the end of 2026, despite initial increases due to acquisitions [36][37] - Current leverage is around two times net debt to adjusted EBITDA, with a comfortable range of two to two and a half times for future acquisitions [39][40] 4. Referral Dynamics and Partnerships - The partnership with Ensign has provided operational benefits, including shared expertise and clinical collaboration, although referrals from Ensign's skilled nursing operations remain low [46][47] - The company is exploring joint venture opportunities with health systems to enhance care delivery and improve clinical outcomes [66][67] 5. Reimbursement and Quality Measures - The Pennant Group has achieved a 4.1 CMS Star Rating, which has helped reduce the differential between Medicare Advantage (MA) rates and fee-for-service rates to 20-25% [58][59] - The company is focused on driving down costs while maintaining quality, which is crucial for negotiations with payers [61][62] 6. Hospice Operations - The company sees potential for growth in hospice length of stay, currently just under 100 days, with a target to improve without exceeding caps [76][77] - The hospice segment is expected to grow in the mid to high single digits, with a focus on maintaining quality care [78][79] 7. Senior Living Performance - The senior living segment has seen high occupancy rates and successful rate increases, attributed to capital investments and improved service offerings [88][89] - The company aims to increase the proportion of healthcare services provided, currently at 20-25%, with a long-term goal of 25-33% [91][92] 8. Labor and Staffing - The company has made significant improvements in caregiver onboarding and retention, leading to decreased turnover and enhanced employee experience [94] - Current staffing levels are sufficient to support increased occupancy, with ongoing efforts to scale as demand grows [94] 9. Future Outlook - The Pennant Group is targeting a 15% margin in senior living, with expectations that increased occupancy and operational efficiencies will contribute to this goal [96][97] Additional Important Insights - The company is actively involved in discussions with CMS regarding reimbursement methodologies, emphasizing the importance of home health services in the continuum of care [71][72] - The focus on leadership development and creating opportunities for local leaders is a core part of the company's strategy, differentiating it in a fragmented market [50][54]
Tempus AI (NasdaqGS:TEM) 2025 Conference Transcript
2025-11-13 16:02
Summary of Tempus AI Conference Call Company Overview - **Company**: Tempus AI - **Industry**: Life Sciences and Diagnostics Key Points AI Integration in Diagnostics and Biopharma - Tempus AI leverages AI across its operations, focusing on enhancing patient care through data and technology [4][5][6] - The company has developed platforms like Hub and Lens to facilitate interaction with diagnostic tests and build patient cohorts, respectively [4][5] - A partnership with AstraZeneca and Pathos aims to create a foundation model to extract insights from large datasets [6] Financial Performance - The third quarter reported a **28% organic growth**, with specific segments showing: - **Genomics**: High 20s growth - **Ambry**: 33% growth - **Data Licensing**: 37% growth [10][12] - Adjusted EBITDA turned positive, marking a significant milestone for the company [13] Oncology and Hereditary Testing - Oncology volumes grew by **27%**, while Ambry benefited from market disruptions in hereditary screening [12][42] - The hereditary testing market is expected to moderate as share gains stabilize [12] Data Licensing and Contracts - Total remaining contract value exceeded **$1 billion**, with a net revenue retention rate of **140%** [48] - New contracts included a **$66 million deal** with a biotech customer and expansions with existing clients [48] - The company anticipates strong engagement from both big pharma and biotech sectors [48] Market Position and Competition - Tempus AI has established connections with over **5,000 institutions**, enhancing its data collection and diagnostic capabilities [19] - The company emphasizes ease of use and connectivity as key differentiators against competitors [20] Reimbursement Trends - Average Selling Prices (ASPs) have increased to approximately **$1,600**, with expectations for **40%** of xT volumes to transition to ADLT pricing by year-end [22][23] - The company aims for **85%** of xT volumes to shift to ADLT pricing by the end of 2026 [23] Clinical Trials and CRO Business - The CRO segment has faced headwinds, but the acquisition of a small CRO aims to enhance clinical trial matching capabilities [61] - The company does not prioritize aggressive growth in the CRO sector but sees potential stabilization as funding for CROs improves [61] Investment and Growth Strategy - Tempus AI plans to reinvest about **two-thirds** of incremental gross profit back into the business over the next three years to support growth [64] - The company aims for long-term growth rates of **25-30%**, focusing on sustainable growth rather than maximizing quarterly revenue [58][64] Gross Margins and Future Outlook - Genomics business margins are expected to stabilize around **low 60%**, while data operations may achieve **mid 70%** margins [66] - AI applications, though currently a small revenue source, are anticipated to positively impact margins as they scale [68] Upcoming Developments - Data from a new ultra-high sensitivity assay for MRD is expected in **2026**, with further developments in breast cancer and immuno-oncology to follow in **2027** [38][39] Additional Insights - The company is cautious about the competitive landscape in MRD testing, focusing on leveraging existing data connections and insights to gain market share [34][35] - Tempus AI's strategy emphasizes long-term relationships with clients to ensure sustained growth and value delivery [58][59]
Lilly(LLY) - 2025 FY - Earnings Call Transcript
2025-09-05 14:32
Financial Data and Key Metrics Changes - The company reported a strong second quarter in 2025, driven by the incretin teams on Mounjaro and Zepbound, particularly in the U.S. and internationally [2] - The U.S. opportunity in type 2 diabetes is significant, with a reported HbA1c reduction of 1.8 and weight loss of 10.5 in the obese population with type 2 diabetes [6][7] - The company anticipates a gradual growth in the second half of the year, contrasting with the strong performance in Q2 [16] Business Line Data and Key Metrics Changes - The composition of the U.S. business is shifting, with 25% of incretin performance coming from type 2 diabetes and 75% from chronic weight management [10] - The company launched Mounjaro in Brazil, Mexico, India, and China, with a significant portion of Q2 sales attributed to chronic weight management [15] - The company expects to see a gradual growth in the second half of the year due to fewer major launches compared to Q2 [16] Market Data and Key Metrics Changes - The U.S. market for oral type 2 diabetes medications is substantial, with approximately 4 million patients on orals each month [6] - The company noted that the majority of its business outside the U.S. is cash-based, with limited reimbursement for chronic weight management [10] - The company is negotiating for type 2 diabetes reimbursement in several international markets, which is expected to take time [10] Company Strategy and Development Direction - The company is focused on launching a rich pipeline of products over the remaining part of the decade, with several launches planned for the second half of the year [2] - The management emphasized the importance of outcome data to gain access and reimbursement for chronic weight management, both in the U.S. and internationally [14] - The company is optimistic about the future of its oncology and neuroscience portfolios, with several promising assets in development [41][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the guidance for 2025, citing a lack of supply constraints that affected previous years [26] - The company is optimistic about the potential for growth in the U.S. diabetes market and is working to improve employer opt-in rates for chronic weight management [27][28] - Management acknowledged the challenges of gaining reimbursement for chronic weight management outside the U.S. but remains committed to differentiating its products [36] Other Important Information - The company is facing legal challenges related to compounding lawsuits but is actively pursuing various strategies to address these issues [45] - The impact of the Inflation Reduction Act (IRA) on the company's business is still uncertain, with management anticipating some effects on Medicare and Medicaid [47] Q&A Session Summary Question: How is the product profile of Orforglipron fitting in the marketplace? - Management indicated that Orforglipron has a strong safety and tolerability profile, with appealing data for both HbA1c reduction and weight loss [3][4] Question: What are the expectations for the U.S. market penetration with R4? - Management believes R4 will be a global player, with significant opportunities in the U.S. market for type 2 diabetes [6][12] Question: How does the company view the impact of the CVS change on Zepbound? - Management noted that the CVS change affected approximately 200,000 patients, but they have seen a return to strong growth in market share for Zepbound [22][23] Question: What is the outlook for the company's guidance compared to last year? - Management stated that the guidance process remains consistent, with more certainty in 2025 compared to the unpredictable conditions of 2024 [25][26] Question: How is the company addressing the access situation for 2026? - Management reported that they have made progress in employer opt-in rates and are in discussions for broader coverage in Medicare [27][28] Question: What is the competitive landscape in international markets? - Management acknowledged increased competition but emphasized their differentiation strategy and premium pricing for Mounjaro [33][36] Question: What are the exciting opportunities in the non-incretin side of the business? - Management highlighted the oncology franchise as particularly promising, with several assets in development that could drive future growth [41][42]
Milestone Scientific(MLSS) - 2025 Q2 - Earnings Call Transcript
2025-08-15 13:00
Financial Data and Key Metrics Changes - Consolidated revenue for Q2 2025 was approximately $2.3 million, an increase of 25% compared to the same period in 2024, driven primarily by the dental segment [11][14] - Consolidated gross profit for Q2 2025 was approximately $1.6 million, an increase of approximately $206,000 compared to approximately $1.4 million for the same period in 2024 [14] - The loss from operations decreased to approximately $1.5 million in Q2 2025 from $1.8 million in Q2 2024, a decrease of approximately $296,000 [16] Business Line Data and Key Metrics Changes - Dental revenue for Q2 2025 was approximately $1.3 million, with international sales more than doubling [14] - Medical revenue increased to approximately $32,000 in Q2 2025 from $19,000 in Q2 2024, reflecting a growth of $13,000 [14] - For the six months ending June 30, 2025, medical revenue was approximately $83,000, an increase of $57,000 compared to the same period in 2024 [17] Market Data and Key Metrics Changes - International revenue for Q2 2025 was approximately $1.49 million, an increase of $511,000 compared to the same period in 2024 [14] - International sales accounted for 48% of total revenues in Q2 2025, driven by additional distributors and larger orders [32] Company Strategy and Development Direction - The company is focusing on accelerating penetration in existing markets, expanding internationally, and capturing greater share in the U.S. dental market through targeted marketing and direct engagement [12] - In the medical segment, the strategy includes building on the reimbursement foundation and pursuing new distribution partnerships both domestically and internationally [12] - The leadership team emphasizes disciplined execution and focused growth in both medical and dental sectors [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the untapped potential of the company, highlighting the importance of disciplined execution and data collection for reimbursement processes [9][25] - The recent addition of key leadership members is expected to drive growth and improve operational efficiency [5][8] - Management acknowledged the challenges in the medical segment but is committed to focusing efforts on a few clinics to gather data and improve adoption rates [25][26] Other Important Information - The company has maintained a solid balance sheet with cash and cash equivalents of $1.3 million and working capital of approximately $3.9 million, with no long-term debt [18] - The company is actively managing expenses and evaluating where to allocate resources for future growth [76] Q&A Session Summary Question: Can you discuss the medical side and adoption of the CompuFlo system? - Management indicated that between five and ten clinics are currently using the product in the U.S. market and emphasized a focused approach to data collection and reimbursement [25][26] Question: Have there been other key hires besides Jason Papes? - Management confirmed that Jason brings a team with him and is evaluating additional hires based on current talent in the marketplace [28][29] Question: What percentage of revenues came from international sales this quarter? - International sales accounted for 48% of total revenues, with growth driven by additional distributors and larger orders [32] Question: What role do tariffs play in international sales? - Management stated that tariffs have been mitigated by shipping directly from their warehouse in China, ensuring that inventory levels remain unaffected [40][42] Question: What is the status of reimbursement with JMAC and private payers? - Management plans to focus on existing users of the CompuFlo system to understand reimbursement processes before expanding to new markets [43][46] Question: How bullish are clinicians on the technology? - Management acknowledged the need for focused efforts to gather insights from clinicians and emphasized the importance of understanding use cases before broader market expansion [55][56] Question: What is the status of the VA opportunities? - Management is actively engaged with VA facilities and plans to focus on one vision to create a successful model before expanding further [66][68] Question: What is the situation with Brazil? - Management indicated that Brazil remains a long-term potential market but is not a focus in the near term due to recent tariffs [70]
IceCure(ICCM) - 2025 Q1 - Earnings Call Transcript
2025-05-28 15:00
Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [12] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with gross margin decreasing from 36% to 30% [12] - Total operating expenses were $3,880,000, slightly down from $3,920,000 in the previous year [12] - Net loss was $3,590,000 or $0.06 per share, compared to a net loss of $3,610,000 or $0.08 per share for the same period last year [12] - As of 03/31/2025, cash equivalents were approximately $6,000,000, increasing to about $6,200,000 by 05/27/2025, which includes a $2,000,000 unsecured bridge loan [12][11] Business Line Data and Key Metrics Changes - The revenue increase was primarily driven by sales in North America and Europe, while sales in Asia declined significantly [12] - The company continues to expect revenue and gross profit to fluctuate quarter to quarter as it builds out its commercial infrastructure [12] Market Data and Key Metrics Changes - In North America, revenue increased by approximately 11% year-over-year, while Europe saw a 60% increase [29] - Sales in Asia experienced a decline of about 60%, with other parts of Asia declining by approximately 40% [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for early-stage breast cancer treatment [5][8] - Following FDA approval, the company plans to commence commercial sales while running a post-market study, which could lead to additional reimbursement opportunities [7][9] - The company is also preparing for potential regulatory filings and approvals in Japan and Israel [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for future marketing authorization [6][7] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption in the market [44] Other Important Information - The company raised $2,650,000 in net proceeds from the sale of ordinary shares under its at-the-market offering facility between 01/13/2025 and 05/27/2025 [14] - The company maintains a supportive relationship with its largest shareholder, who provided a $2,000,000 unsecured loan [10] Q&A Session Summary Question: Is the post-market study expected to involve a minimum of 400 patients over 25 sites? - Yes, the post-market study will require 400 patients in at least 25 sites, but the FDA cannot guarantee a specific response time for the submission [18][19] Question: How long is the post-market study expected to take? - The recruitment for the study is expected to be completed within three years [21][22] Question: Can you provide more details on the potential for expanded reimbursement? - The company believes it can increase reimbursement rates after obtaining more records and claims under the CPT3 code, and plans to apply for a CPT1 code post-authorization [23][24] Question: What is the size of the breast cancer patient population in Japan? - The total number of new breast cancer cases in Japan is between 100,000 and 105,000 annually, with a significant portion being low-risk early-stage cases [25][26] Question: What was the geographic breakdown of revenue this quarter? - North America saw an 11% increase in revenue, while Europe experienced a 60% increase; however, Asia saw a decline of about 60% [29][30] Question: Is ProSense subject to any new tariffs for U.S. markets? - Yes, the company is currently affected by tariffs imposed by the U.S. Administration, but the situation is still evolving [36][37] Question: Will the sales team expand after post-market approval? - Yes, the company plans to increase its sales team following marketing authorization [38] Question: What are the pricing and sales strategies for ProSense? - The company plans a mix of placement and outright sales, requiring commitments for probe usage over a period [40]