Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $14.7 million for Q2 2025, compared to a net loss of $13.6 million in Q2 2024, primarily due to a $400,000 increase in gross loss and a $1 million increase in finance expenses, offset by a $400,000 decrease in operating expenses [34] - Revenue for the reported period was $3 million, with a gross loss of $3.2 million on a GAAP basis, compared to revenue of $2.7 million and a gross loss of $2.9 million in the comparable period [34] - Non-GAAP gross loss for the reported period was $600,000, representing a gross loss margin of approximately 21%, compared to 9% in the comparable period [35] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for the reported period was $2.7 million, with a gross profit of $500,000, compared to revenue of $2.5 million and a gross profit of $400,000 in the comparable period, indicating a gross profit margin increase from 15% to 18% [35] - Revenue from imaging systems and OEM services amounted to $221,000, with a gross loss of $1.7 million, compared to revenue of $68,000 and a gross loss of $1.3 million in the comparable period [36] - Revenue from AI solutions for the reported period was $100,000, with a gross loss of $2 million, consistent with the previous period [36] Market Data and Key Metrics Changes - The company is focusing on expanding its commercial footprint in the U.S. market while also establishing a presence in European countries such as Romania and Greece following the CE Mark designation [6][22] - The company has installed systems in various facilities, primarily in small and medium-sized health clinics, with over 20 systems currently operating and scanning patients [45] Company Strategy and Development Direction - The company aims to install 100 Nanox ARC systems by the end of 2025, with a focus on disciplined execution and expanding its commercial footprint [5] - The strategy includes partnerships with academic institutions and clinical education initiatives to enhance the adoption of Nanox technology [7][10] - The company is developing a mobile imaging solution to improve access to diagnostic imaging services [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting revenue growth expectations for 2025, driven by increased installations and customer retention [7][40] - The company anticipates that operating expenses will remain stable, with a focus on efficiency while increasing sales and marketing efforts [60] Other Important Information - The company has entered into a multi-year volume supply agreement with Fabrinet to support scalable production of advanced medical imaging systems [33] - The company is actively pursuing collaborations with AI platform providers to enhance its offerings and expand its market reach [19][20] Q&A Session Summary Question: How many systems were operating during the quarter that resulted in $221,000 in imaging-related revenue? - More than 20 systems are currently operating and scanning patients, with a significant increase in the number of leads and installations expected [45][46] Question: Are you expecting any of the 100 leads to be capital sales? - A portion of the leads will be CapEx sales, particularly in the U.S. market [47] Question: How many states in the U.S. are you now approved in for users to operate a system? - The company is currently approved in eight states [48] Question: Could you talk about the current revenue model? - The leading model is the MTSS model, but there will be a mixture of CapEx sales and MSOS model in the U.S. market [53] Question: What should be expected for the AI Solutions revenue going forward? - Continuous growth is expected, with 2026 projected to be breakeven in terms of revenues and expenses for AI solutions [55] Question: Any trends expected in operating expenses? - Operating expenses are expected to remain consistent, with a focus on maintaining efficiency while increasing sales and marketing activities [60]

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.2 million for Q1 2025, compared to a net loss of $12.2 million in Q1 2024, reflecting an increase of $1 million largely due to a $1.1 million increase in gross loss [29] - Revenue for the reported period was $2.8 million, with a gross loss of $3 million on a GAAP basis, compared to revenue of $2.6 million and a gross loss of $2.1 million in the comparable period [29][30] - Non-GAAP gross loss for the reported period was $400,000, down from a gross profit of $600,000 in the comparable period, indicating a gross margin of approximately 15% [30] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for the reported period was $2.6 million, with a gross profit of $400,000, compared to revenue of $2.4 million and a gross profit of $300,000 in the comparable period, representing a gross profit margin of approximately 17% [30] - Revenue from the sale and deployment of imaging systems and OEM services amounted to $33,000, with a gross loss of $1.6 million on a GAAP basis, compared to revenue of $47,000 and a gross loss of $400,000 in the comparable period [31] - The company's revenue from AI solutions for the reported period was $200,000, with a gross loss of $1.9 million on a GAAP basis, compared to revenue of $100,000 and a gross loss of $2 million in the comparable period [31] Market Data and Key Metrics Changes - The company has seen an increase in the number of scans performed by its systems, with an average target of seven scans per day for operational units [12] - The sales pipeline has doubled since January 2025, with the sales team handling over 1,000 leads, primarily from small and medium-sized health clinics in various countries [11][12] - The company is targeting over 100 ARC systems in various stages of deployment by the end of 2025 worldwide [12] Company Strategy and Development Direction - The company aims to improve medical imaging and enhance patient outcomes through strategic acquisitions and the integration of AI-powered imaging analysis [6][7] - The focus is on expanding the teleradiology business and AI solutions to create a comprehensive end-to-end medical imaging solution [8][9] - The company is preparing to ship its first systems to Puerto Rico and has made notable progress in forming distributor partnerships in the U.S. [15][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges recent market uncertainties but remains encouraged by the growing base of early adopters of the Nanox Arc [13] - The company expects its AI business to break even in 2026 and the ARC business to break even in 2027, with an inflection point anticipated in the second half of 2025 [61][62] - Management emphasizes the importance of clinical validation and regulatory approvals in driving future growth [23][35] Other Important Information - The company had cash, cash equivalents, restricted deposits, and marketable securities of approximately $72.9 million as of March 31, 2025 [33] - The company continues to strengthen its sales and clinical teams to support its commercialization efforts in the U.S. market [14] Q&A Session Summary Question: Can you provide details on the fleet of units expected by the end of the year? - Management indicated that the majority of units will be in the U.S., with about 15-20% in Europe and 10% in other regions, depending on regulatory approvals [40] Question: What is the pricing and reimbursement status for the second opinion services? - The second opinion service is priced at approximately $300 and is primarily a retail model, with growing business [45][46] Question: How many units are currently deployed and operational in the U.S.? - More than 20 units are currently installed, with some awaiting regulatory approvals [52] Question: When can the company expect to reach breakeven? - The AI business is expected to break even in 2026, while the ARC business is projected to break even in 2027, with an inflection point anticipated in the second half of 2025 [61][62]

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.2 million for Q1 2025, compared to a net loss of $12.2 million in Q1 2024, reflecting an increase of $1 million largely due to a $1.1 million increase in gross loss [27] - Revenue for Q1 2025 was $2.8 million, with a gross loss of $3 million, compared to revenue of $2.6 million and a gross loss of $2.1 million in the same period last year [27][28] - Non-GAAP gross loss for Q1 2025 was $400,000, down from a gross profit of $600,000 in Q1 2024, indicating a gross margin of approximately 15% for the reported period [28] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for Q1 2025 was $2.6 million, with a gross profit of $400,000, compared to $2.4 million and a gross profit of $300,000 in Q1 2024, representing a gross profit margin of approximately 17% [28] - Revenue from imaging systems and OEM services was $33,000 with a gross loss of $1.6 million in Q1 2025, compared to revenue of $47,000 and a gross loss of $400,000 in the same period last year [29] - Revenue from AI solutions was $200,000 with a gross loss of $1.9 million in Q1 2025, compared to $100,000 and a gross loss of $2 million in Q1 2024 [29] Market Data and Key Metrics Changes - The sales pipeline has doubled since January 2025, with the sales team handling over 1,000 leads, primarily from small and medium-sized health clinics in various countries [9] - The company is targeting over 100 ARC systems in various stages of deployment by the end of 2025, with over 60 units currently in various stages of implementation [10][11] Company Strategy and Development Direction - The company aims to improve medical imaging and enhance patient outcomes through strategic acquisitions and the integration of AI-powered imaging analysis [6][7] - The focus is on expanding the commercialization of Nanox ARC and AI solutions, with a multi-pronged strategy involving direct sales, collaborations, and distributor engagements [8][12] - The company is also pursuing opportunities in the workers' compensation segment, which presents a significant potential market [14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged recent market uncertainties but expressed optimism about the growing base of early adopters for Nanox ARC [11] - The company expects its AI business to break even by 2026 and the ARC business to reach breakeven by 2027, with an anticipated inflection point in the second half of 2025 [57][58] Other Important Information - The company has received FDA clearance for the Nanox Arc X, enhancing its regulatory standing [20] - The company is actively engaged in clinical trials to generate data supporting the use of Nanox Arc, which is crucial for future growth [21] Q&A Session Summary Question: Can you provide details on the fleet deployment by the end of the year? - Management indicated that the majority of units will be in the US, with about 15-20% in Europe and 10% in other regions, depending on regulatory approvals [38] Question: What is the pricing and reimbursement status for the second opinion services? - The second opinion service is priced at approximately $300 and is primarily a retail model, with growing business potential [42] Question: How many units are currently deployed and operational in the US? - More than 20 units are currently installed, with some awaiting regulatory approvals [47] Question: What is the timeline for reaching breakeven across business lines? - The teleradiology division is already profitable, while the AI business is expected to break even in 2026 and the ARC business in 2027 [56][57]

Assertio Holdings (ASRT) Conference Summary Company Overview - Assertio Holdings is a specialty pharmaceuticals company with a market cap of approximately $70 million and shares trading at around 70¢ [2][4] - The company is focused on long-term growth and has a leadership team with extensive commercial experience in various therapeutic areas [5][6] Core Assets and Financial Performance - Assertio's core assets include Rovidone and SYMPAZAN, with Rovidone being a novel long-acting G-CSF approved in the last twenty years, targeting a market worth about $1 billion [8][9] - The company reported net sales of $26 million for the first quarter and maintains a positive adjusted EBITDA with a cash balance of nearly $90 million [9] - The financial outlook for the year includes projected net sales of $108 to $123 million and non-GAAP EBITDA of $10 to $20 million [10] Transformation and Growth Strategy - The company is in a transformation phase, simplifying its corporate structure and optimizing its asset portfolio, focusing on growth assets like Rovidone and SYMPAZAN [12][15] - Assertio aims to reduce legal exposure, which will allow for reinvestment into the business and positively impact EBITDA [13][14] - Business development is seen as a key enabler for future growth, with a focus on oncology, neurology, and rare diseases [14] Product Insights - Rovidone contributes over half of the total net sales and is expected to grow modestly this year, with plans to expand into the commercial segment by 2026 [19][21] - SYMPAZAN, an oral film formulation for Lennox Gastaut syndrome, is projected to grow to $13 million this year and has the potential to reach $25 million in the coming years [28] Competitive Landscape - The market for white blood cell stimulants is competitive, with Rovidone competing against biosimilars like Neulasta. Assertio is focused on managing average selling prices (ASP) smartly to sustain growth [23][24] Legal and Operational Improvements - Assertio has successfully reduced its litigation overhead, particularly related to opioid litigation, which has allowed for a cleaner balance sheet and operational focus [36][38] - The company has divested certain assets to streamline operations and eliminate legal distractions [38] Future Outlook - The CEO expressed optimism about the company's trajectory, aiming for significant growth and improved operational efficiency over the next year [41][42] - Assertio is positioned to explore mergers and acquisitions to enhance its portfolio, supported by a strong balance sheet with $40 million in convertible debt due in 2027 [34][35] Key Takeaways - Assertio is undergoing a transformation aimed at growth, with a focus on optimizing its asset portfolio and reducing legal distractions [12][15] - The company has a solid financial outlook and is strategically positioned to capitalize on growth opportunities in specialty pharmaceuticals [10][14] - Assertio's leadership is optimistic about future performance, with plans to enhance product offerings and expand market presence [41][42]