Financial Data and Key Metrics Changes - Revenues for Q2 2025 were $894,000, up 46% compared to $612,000 in Q2 2024, marking the fourth consecutive quarter of double-digit growth [27] - Revenue for the six months ended June 30, 2025, increased to $1,800,000, up 42% from $1,300,000 for the same period in 2024 [27] - Operating loss in 2025 was $1,700,000, a decrease of 22% compared to a $2,200,000 loss in 2024 [33] - Net loss in 2025 was $1,700,000, down 42% from $2,900,000 in 2024 [34] Business Line Data and Key Metrics Changes - Unit sales increased approximately 5853% for the three and six months ended June 30, 2025, due to volume growth from patients with health insurance coverage and the company's financial assistance program [27] - Average selling prices for patients receiving IV stem through financial assistance are about 65% below the list price [9] Market Data and Key Metrics Changes - Approximately 53 million covered lives have been reached for medical policy coverage, which is seen as a key driver for revenue growth [12] - The company expects revenue growth to accelerate as payer medical policy coverage increases and the new category one CPT code becomes effective on January 1, 2026 [22] Company Strategy and Development Direction - The company is focused on securing broad medical policy coverage and advancing disciplined commercial execution to drive utilization and scale [25] - The introduction of the category one CPT code is expected to facilitate easier billing and reimbursement, significantly impacting revenue potential [19] - The company is also advancing the RED product line, which is in the soft launch phase, with plans for a hard launch [23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the commercialization strategies and the expected revenue growth due to recent milestones, including FDA indication expansion and published clinical practice guidelines [7][14] - The management highlighted that the guidelines published by academic societies are crucial for gaining insurance coverage and improving treatment access [16] Other Important Information - The gross margin for 2025 was 83.6%, down from 88% in 2024, primarily due to higher discounting in the financial assistance program [28] - Cash on hand as of June 30, 2025, was $6,000,000, with the company having secured $5,000,000 through an equity financing round [34] Q&A Session Summary Question: Perceptions from larger insurance plans post-guideline publishing - Management noted positive responses from insurance plans, with some agreeing to interim reviews due to the guidelines, indicating favorable perceptions [40][41] Question: Goals for coverage and prior authorization expectations - Management expects some medication requirements to be removed, allowing for earlier use of IV stem treatments, although this will be a gradual process [44][45] Question: Salesforce expansion triggers - The urgency for payer policy coverage is aligned with the urgency on the commercial side, with plans to expand the sales force as insurance coverage increases [48][49] Question: Discount rates and cash pay devices - Management clarified that 70% of patients initially face a "no auth required" response, limiting treatment options, and discussed the average selling price for patients receiving financial assistance [54][58] Question: Approval for adults to use the IV stem device - The company is in discussions with the FDA regarding adult usage and expects to have an answer by the Q4 call [65] Question: Satisfaction with RVUs and reimbursements - Management expressed satisfaction with the RVU assignment of 1.46 and noted that reimbursement values are favorable, exceeding the cost of the device [70][71] Question: General and administrative expenses and leverage - Management discussed achieving operating expense leverage while continuing to invest in growth areas such as sales and R&D [73][74] Question: Current cash balance and future outlook - The current cash position is sufficient to support operations into 2026, with expectations for improved insurance coverage positively impacting liquidity [78]

Financial Data and Key Metrics Changes - Total revenues for the first half of 2025 reached approximately €100 million, marking a significant year-over-year growth [4] - Cash position exceeded €160 million, indicating a strong cash influx and reduced operating cash burn [4][29] - Product sales increased to €91 million from €68.3 million in 2024, representing a growth of 33.3% [23] - Total revenues rose to €97.6 million from €70.8 million in 2024, an increase of 37.8% [25] - Adjusted EBITDA for 2025 was reported at minus €6.8 million, compared to a positive EBITDA of €66.2 million in the previous year [29] Business Line Data and Key Metrics Changes - IXIARO sales reached €54.7 million, increasing by 30.6% year-over-year [23] - DUKORAL sales grew by 16.4% to €17.4 million, supported by a sale to combat a cholera outbreak [24] - XGIC sales surged to €7.5 million from €1 million in 2024, benefiting from a supply to address a chikungunya outbreak [25] Market Data and Key Metrics Changes - The company secured additional marketing authorizations for XGIC in the UK, Brazil, and label extensions in Europe [6] - The company responded to public health needs by supplying vaccines during outbreaks in La Réunion and Mayotte [5][6] Company Strategy and Development Direction - The company aims to address unmet medical needs and expand its vaccine portfolio, particularly focusing on Lyme disease, chikungunya, and Shigella [5][19] - The partnership with CSL for vaccine distribution in Germany is expected to enhance market access and sales potential [56] - The company is focused on strategic investments in R&D and anticipates continuous growth in product sales [30][32] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of the Lyme disease vaccine program as a major catalyst for future growth [32] - The company expects a significantly lower cash burn in operations, targeting a reduction of over 50% year-over-year [30] - Management expressed confidence in the ongoing clinical trials and the potential for successful vaccine approvals [32] Other Important Information - The company reported a gross margin improvement on commercial products, with IXIARO achieving a gross margin of 65.5% [26] - R&D expenses increased to €32.4 million, driven by costs related to the Shigella vaccine candidate [27] Q&A Session Summary Question: Will there be additional revenue recognition for the 40,000 doses sold to the French government in Q3? - Management confirmed that all doses were shipped in the first half of the year, and revenue will be recognized in that period [40] Question: Can you provide insight on the demand scenarios for XGIC considering the chikungunya outbreak? - Management acknowledged the critical epidemiological situation and emphasized the company's readiness to respond to outbreaks [38] Question: What is the expected timeline for the Lyme vaccine data readouts? - Management indicated that top-line data is expected by the end of the first quarter of 2026, with detailed results to follow [47][66] Question: What are the expectations for sales uptake in the traveler market for XGIC? - Management noted that the recent lifting of restrictions should lead to increased market uptake and ongoing discussions for stockpiling in the U.S. [56] Question: What is the bar for success for the Lyme vaccine trial? - Management stated that while direct comparisons to previous vaccines are challenging, they expect a different efficacy profile based on their current study design [62]

Financial Data and Key Metrics Changes - The company is targeting a quarterly EPS run rate of $2, which is considered achievable with concrete plans in place [9][13] - Free cash flow generation is prioritized, with a guide of $700 to $800 million for the year, translating to approximately $7 per share [18][68] - The company reported a sequential negative impact of $25 million in Q3 due to inventory reduction efforts [17][22] Business Line Data and Key Metrics Changes - In the Engineered Materials segment, there has been a noted weakness in demand from China and Europe, while the Americas remained stable [6][7] - The Acetyl segment is expected to see flat performance compared to Q2, with no significant changes anticipated in the near term [98] Market Data and Key Metrics Changes - The company is experiencing the lowest demand levels in the Western Hemisphere for acetyl products in 20 years, with a 5% to 6% decline in volumes compared to the first half of the previous year [72][73] - The visibility of the order book has decreased significantly, with only two weeks of reliable orders in Engineered Materials [58] Company Strategy and Development Direction - The company is focusing on cost structure improvements and executing differentiated business models to achieve its EPS target [9][13] - There is an emphasis on diversifying the Engineered Materials business beyond automotive applications, exploring opportunities in drug delivery, performance footwear, and clean energy [94] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to adapt to changing demand and emphasized the importance of cash generation [18][37] - The company is prepared to pivot with demand changes and is actively working on controllable actions to improve profitability [13][39] Other Important Information - The company is undergoing a divestiture process, with the MicroMax project progressing well and expected to yield positive results in the second half of the year [102] - The company has extended its revolver to 2030, ensuring sufficient liquidity to address upcoming maturities [60][62] Q&A Session Summary Question: What end markets are seeing weakening demand? - Management noted a pullback in China automotive orders and some weakness in European demand, while the Americas remained stable [6][7] Question: How does the company plan to achieve the $2 EPS target? - The company has identified four controllable areas to improve cost structure and pricing, which will help reach the target, albeit potentially delayed [9][13] Question: Are tariffs affecting the tow business in China? - Management confirmed that the tow business in China is not impacted by tariffs as it operates through a joint venture [27] Question: What is the outlook for the acetic acid business in China? - Management indicated that the acetic acid business is currently breakeven and is pivoting towards downstream products for better margins [28] Question: How does the company view the current demand environment? - Management described the demand environment as uncertain, with customers reducing inventories, impacting sales [82][84] Question: What is the status of the MicroMax divestiture process? - The MicroMax process is progressing well, with management confident in achieving positive outcomes in the near future [102]

Financial Data and Key Metrics Changes - For the quarter ended June 30, core net investment income was $0.27 per share, while GAAP net investment income was $0.25 per share [5][17] - As of June 30, net asset value (NAV) was $10.96 per share, down 1% from $11.07 per share in the prior quarter [17] - The debt to equity ratio was 1.3 times, indicating a diversified capital structure across multiple funding sources [17] Business Line Data and Key Metrics Changes - The portfolio grew to $2.4 billion, up from $2.3 billion in the prior quarter, with a weighted average yield on debt investments of 10.4% [12][18] - The portfolio comprised 90% first lien senior secured debt, with only 1% in subordinated debt and 2% in equity of PSSL [18] - The weighted average debt to EBITDA for new platform investments was 3.8 times, with an interest coverage ratio of 2.6 times [8][19] Market Data and Key Metrics Changes - The company noted a rebound in deal activity, which is expected to lead to increased loan originations in the second half of 2025 [4][6] - The pricing on high-quality first lien term loans in the core middle market is over plus $4.75 to $5.25, with meaningful covenant protections [7][10] Company Strategy and Development Direction - The company formed a new joint venture with Hamilton Lane, committing $200 million in capital, with an expected total portfolio of $500 million [6][14] - The focus remains on capital preservation and finding investment opportunities in growing middle market companies with high free cash flow conversion [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong outlook for the remainder of the year, anticipating continued net investment income growth and full dividend coverage [6][36] - Credit quality remains strong, with a low nonaccrual rate of 1% at cost and 0.5% at market value [8][18] Other Important Information - The company raised $32 million from the issuance of 2.8 million shares at an average price of $11.31 per share during the quarter [13] - The PSSL joint venture portfolio totaled $1.1 billion, with plans to grow to $1.4 billion [14] Q&A Session Summary Question: How much of the $500 million could be deployed over the next few quarters? - Management anticipates a ramp-up period of 12 to 18 months for deploying the capital, with potential for growth beyond the initial amount [23][24] Question: What are the long-term growth plans for PFLT and PNNT? - Management emphasized that growth will be organic based on market opportunities, with the potential for future mergers always on the table [28][30] Question: What is the timing for net investment income to fully cover the dividend? - Management identified three levers for NII growth: increasing leverage to target ratios, filling out the PSSL joint venture, and ramping up the new Hamilton Lane JV [33][35] Question: What is the current state of EBITDA growth at the portfolio company level? - EBITDA growth is generally in the mid to upper single digits, with low nonaccruals and maintained leverage levels [36][38] Question: Will the high level of unrestricted cash be directed towards the JV? - Some of the unrestricted cash will be used for the JV, but it also reflects timing from cash management [41] Question: Is there expected to be improved loan pricing power? - Management hopes to maintain or expand loan spreads due to increased supply, while prioritizing credit quality [42][44] Question: Is there a mix shift in the pipeline regarding industries or borrowers? - Recently, there has been an increase in new platforms coming to the company, with a focus on incumbency and add-on loans [48][51]

Financial Data and Key Metrics Changes - The company's net contribution for Q2 2025 increased by 26% year over year to $210 million, while adjusted EBITDA grew by 31% year over year to $72 million, with an adjusted EBITDA margin of 34%, expanding 140 basis points from the previous year [13][24][23] - Assets Under Administration (AUA) increased by 54% year over year to $7.5 billion, and funded accounts grew by 14% year over year to 3.63 million [24][23] - Adjusted EPS for the quarter was $0.56 compared to $0.51 in Q2 2024 [26] Business Line Data and Key Metrics Changes - Net trading contribution from equities, commodities, and currencies grew by 37% year over year to $114 million, driven by a 54% increase in invested amount per trade [24][25] - Net contribution from crypto increased by 34% year over year to $27 million, primarily due to higher invested amounts per trade, despite lower overall crypto activity [24][25] - Interest earning assets contributed $46 million, up 1% year over year, while eToro Money contribution grew by 17% year over year to $18 million [25] Market Data and Key Metrics Changes - The company expanded its global footprint by activating its license in Singapore, positioning itself to serve Asia's growing investor base [13] - The U.S. market saw significant expansion in crypto offerings, now providing access to over 100 different crypto assets [15][24] Company Strategy and Development Direction - eToro aims to be a leading trading investment platform, focusing on product development across four strategic pillars: trading, investing, wealth management, and neo banking [12] - The company is committed to leveraging AI technology to enhance the investing experience and democratize access to quantitative trading tools [19][20] - eToro is exploring the tokenization of assets, anticipating a significant transfer of wealth as traditional assets move onto the blockchain [15][39] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth opportunities in the U.S. and Asia, particularly with the recent regulatory developments around crypto [15][70] - The company is focused on sustainable, profitable revenue growth through diversification of revenue streams and disciplined cost management [22][23] - Management noted that while Q2 saw elevated trading activity, normalization is expected in subsequent months, with a positive outlook for crypto activity in July [27][34] Other Important Information - The company launched the eToro MoneyCard across Europe, which offers a 4% stockbroker reward on purchases [18] - eToro is actively working on expanding its product offerings, including the introduction of staking and CopyTrader for U.S. customers [48][70] Q&A Session Summary Question: When does eToro plan to provide calls and puts options to European investors? - eToro plans to expand options trading to Europe, UAE, Singapore, and Australia over the next twelve months, following initial launches in the U.S. and the UK [28] Question: Can you provide insights on the cadence throughout the quarter? - Elevated trading activity was observed in April, normalizing towards the end of Q2, with a noted increase in crypto trading in July [31][34] Question: What is the revenue opportunity from tokenized stocks? - eToro anticipates a significant process of digitization and tokenization of assets, expecting $100 trillion of assets to move on-chain over the next twenty years [38][39] Question: What is the update on CopyTrader in the U.S.? - eToro plans to launch CopyTrader for U.S. customers later this year, with significant progress made in expanding crypto offerings [48][70] Question: How is account growth dynamics across regions? - Growth is balanced across regions, with notable growth in the UAE, and overall funded accounts are expected to continue growing [51] Question: What is the outlook for funded account growth in the APAC region? - The company sees significant growth opportunities in Asia, particularly through its new license in Singapore [64] Question: What is the percentage mix from CFDs in net trading income? - The company does not break down net trading income by transaction type but aims to reach a 20% mark for CFDs in the coming months [94]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $433 million, representing an 11% organic growth driven by colocation, lease amendments, new sites, and CPI escalators [8][12] - Adjusted EBITDA was $248.5 million with a margin of over 57%, stable year-on-year, indicating continued financial discipline [8][19] - ALFCF was $54 million, reflecting a 19% decrease year-on-year due to a different interest rate profile following the November 2024 bond refinancing [16][19] - Total CapEx decreased by 14% year-on-year to $46 million, attributed to more disciplined capital allocation [8][19] Business Line Data and Key Metrics Changes - In Nigeria, revenue was $260 million, with strong organic growth of over 10% year-on-year despite a reduction in revenue from vacated tenants [20][21] - The Sub-Saharan African segment saw an 18% increase in revenue, while adjusted EBITDA decreased by 4% year-on-year due to higher costs [25] - The LatAm segment experienced a 6% organic growth year-on-year, with towers and tenants growing by 7.3% and 9.7% respectively [26] Market Data and Key Metrics Changes - The Nigerian naira stabilized, with an average FX rate of 15.81 naira to the dollar in Q2 2025, impacting revenue reporting [14][24] - Macroeconomic indicators in Nigeria showed positive trends, including a drop in inflation and an increase in crude oil production [22][23] Company Strategy and Development Direction - The company is focused on organic growth, efficiency, and cash flow, with a strategy to prioritize debt repayment while exploring growth opportunities [10][11] - Plans to evaluate the introduction of dividends or share buybacks as leverage approaches the low end of the target range [10][29] - The ongoing rollout of 5G and tariff increases in Nigeria are expected to drive sustained growth [11] Management's Comments on Operating Environment and Future Outlook - Management raised the full-year 2025 outlook across all key metrics, citing an improving macroeconomic environment and telecom market performance [6][10] - The company anticipates continued strength in collocations and lease amendments, particularly in Nigeria and Brazil [44] Other Important Information - The company repaid $154 million of high-interest debt, reducing the weighted average cost of debt by 100 basis points [9][27] - The consolidated net leverage ratio improved to 3.4x, down from 3.9x a year ago, with expectations for further reduction by year-end [9][29] Q&A Session Summary Question: What is driving the strong lease amendments and colocations? - Management indicated that the strong activity is primarily from Nigeria and Brazil, with expectations for continued strength through the year [35][36] Question: Can you explain the expected ramp in CapEx for the second half of the year? - Management confirmed that the CapEx guidance is loaded for H2, primarily due to rollout projects in Brazil and Sub-Saharan Africa [37][38] Question: How do you expect organic growth to trend heading into 2026? - Management expects continued strength in collocations and lease amendments, particularly in Nigeria and Brazil, with a moderate impact from CPI and FX resets [42][44] Question: What is the rationale for considering additional asset sales? - Management stated that further asset disposals would be considered if they drive shareholder value, with a focus on maintaining growth [50][52] Question: What is the outlook for interest costs moving forward? - Management is focusing on repaying expensive debt and optimizing the balance sheet, but did not provide specific forecasts for interest rates [78][80]

Financial Data and Key Metrics Changes - The company reported a 19% increase in operating earnings for Q4 and a 15% increase for the year [10] - EPS grew by 13% in Q4 and over 9% for the year [10] - Adjusted free cash flow for the year was $2.5 billion, exceeding expectations by $500 million [11] - Total company revenue was relatively flat at $60.2 billion, but increased by 21% when adjusting for contract expiration [12] - Gross profit grew 17% to $2.2 billion, with a gross margin improvement of approximately 50 basis points [12] Business Line Data and Key Metrics Changes - Pharmaceutical segment revenue was flat at $55.4 billion, but increased by 22% excluding customer contract expiration [16] - The Pharma segment profit increased by 11% to $535 million, driven by brand and specialty pharmaceutical sales [16] - GMPD revenue grew 3% to $3.2 billion, with segment profit reaching $70 million, its highest quarter [18] - Other growth businesses reported a 37% revenue increase to $1.6 billion and a 44% profit increase to $160 million [19] Market Data and Key Metrics Changes - The company saw strong pharmaceutical demand across all business areas, including brand, specialty, generics, and consumer health [16] - The At Home Solutions segment, including the ADS acquisition, experienced significant growth, contributing to overall revenue increases [20] - The nuclear and precision health solutions segment outpaced the market, with revenue growth over 30% [44] Company Strategy and Development Direction - The company is focused on driving simplification and operational efficiencies while making strategic investments for growth [6] - The acquisition of Solaris Health is expected to enhance the company's position in the specialty market, particularly in urology [7][38] - The company aims to expand its distribution capabilities and modernize its technology platforms to enhance customer service [35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for fiscal year 2026, expecting EPS growth of 13% to 15% [23] - The company anticipates continued strong demand across its business segments, with a focus on customer experience as a key differentiator [34] - Management remains confident in the company's resilient business model amid regulatory changes and market dynamics [49] Other Important Information - The company completed four strategic acquisitions during the year, including Green Specialty and ADS [11] - The effective tax rate for the fourth quarter was 26.3%, slightly higher than the previous year [13] - The company plans to maintain a baseline of annual share repurchases at $750 million [32] Q&A Session Summary Question: Can you discuss the updated guidance for the Pharmaceutical and Specialty Solutions division? - Management confirmed that the guidance was raised by $0.20, with half attributed to liability classification and the other half to higher expectations for Pharma and other businesses [54] Question: What are the drivers behind the increase in SG&A? - Management indicated that the majority of the SG&A increase is tied to recent acquisitions, with ongoing efforts to simplify and optimize operating costs [58] Question: Can you elaborate on the gross profit performance and margin expansion? - Management noted that the emphasis on specialty distribution and additional revenue streams from MSO acquisitions contributed positively to the overall gross profit profile [68] Question: What are the utilization trends in the GMPD segment? - Management stated that utilization remains consistent, with ongoing efforts to increase penetration of Cardinal Health branded products [73] Question: Can you provide insights on the Solaris acquisition and its impact? - Management highlighted that Solaris Health adds significant capabilities and revenue streams, enhancing the company's position in the urology market [81][84]

Financial Data and Key Metrics Changes - Net income increased by 77% year on year, reaching BRL 2.1 billion, driven by financial asset bifurcation, lower amortization from the extended concession agreement, and interest and monetary correction from the reversal of legal accruals [5][6] - EBITDA growth was supported by price increases and disciplined cost control, with a year-on-year contribution of approximately BRL 200 million from changes in legal claims management [4][6] - CapEx totaled BRL 3.6 billion in Q2 2025, a 178% increase year on year, indicating a strong commitment to infrastructure investment [5][9] Business Line Data and Key Metrics Changes - Volume growth contributed 3.5%, with 1.5% from new connections for water and sewage, and a 2% increase in consumption despite lower temperatures [2][3] - Average prices rose by 5% due to tariff adjustments, although a decline was noted in June due to a 1% tariff decrease [2][3] - The removal of discounts for large clients resulted in an average price increase of 47% compared to Q4 2024 [3] Market Data and Key Metrics Changes - The company reported a significant reduction in complaints about water shortages by 18% and water leaks by 23% quarter over quarter [10] - The introduction of smart metering technology is expected to enhance operational efficiency and customer service [11][60] Company Strategy and Development Direction - The company’s strategy focuses on three priorities: meeting new concession agreement challenges, raising operating standards, and boosting financial efficiency [8][9] - The CapEx execution is accelerating, with a backlog of BRL 35 billion across 542 projects scheduled for completion by 2029 [9] - The company aims to enhance customer experience through technology-driven initiatives, including a new customer service channel via WhatsApp [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company’s transformation and progress towards universalization targets, with over 1.3 million people gaining access to water and 1.4 million to sewage treatment [14][82] - The company is focused on balancing efficiency gains with annual targets amidst a heated demand for services in São Paulo [77][78] Other Important Information - The company is ahead of schedule on its 2425 U factor targets, with water units target already met and significant progress in sewage collection and treatment [5][6] - The leverage remains under control, with net debt to adjusted EBITDA at 1.9 times, reflecting a strong balance sheet [6] Q&A Session Summary Question: Details on OpEx performance and future expectations - Management highlighted that the efficiency program is crucial for sourcing funds for investments, with personnel expenses reflecting voluntary dismissal plans [20][21] - The impact of social tariff evolution was discussed, with BRL 170 million invested in discounts for vulnerable populations [26][27] Question: Universalization CapEx and project completion - Management confirmed that the company is on track to meet sewage connection targets, with 15 projects in the northern metropolitan region of São Paulo expected to deliver 500,000 connections by year-end [33][34] Question: General and administrative expenses - The negative BRL 50 million expense was attributed to a reversal of provisions, with expectations for future levels discussed [44][45] Question: Increase in delinquency rates - The increase was attributed to prior settlements with delinquent customers and the removal of discounts, with expectations for a change in delinquency profile in Q3 [54][55] Question: Smart metering agreement details - The company has partnered with Vivo for the rollout of smart meters, which will enhance operational efficiency and customer service [58][60] Question: Tariff review process and public disclosure - Management clarified the timeline for the tariff review process and the importance of public hearings for stakeholder input [62][66]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $35.4 million, representing an 18% increase compared to $29.9 million in Q2 2024 [13] - Gross margin improved to 68.6% from 62.1% year-over-year, driven by a favorable sales mix and improved production efficiency [14] - Net income for Q2 2025 was $3.5 million, compared to a net loss of $3.9 million in Q2 2024 [16] - Adjusted EBITDA for Q2 2025 was $6.9 million, a significant improvement from an adjusted EBITDA loss of $0.6 million in the same period last year [17] Business Line Data and Key Metrics Changes - Biologics revenue grew over 20% year-over-year, contributing significantly to overall revenue growth [7] - Hardware product family experienced a 20% decline, amounting to a $2.7 million decrease compared to the previous year [13] Market Data and Key Metrics Changes - Licensing revenue for Q2 2025 included nearly $5 million from agreements related to Q codes and the SIMPLIMAX dual layer amniotic membrane [7] - The company anticipates an additional $5 million in licensing revenue for the remainder of 2025 [22] Company Strategy and Development Direction - The company plans to use proceeds from the sale of non-core assets to reduce long-term debt and enhance cash liquidity [5][6] - Focus will shift towards driving growth in the biologics platform, with an emphasis on organic revenue growth and profitability [10] - The company raised its full-year 2025 revenue guidance to a range of $131 million to $135 million, reflecting an expected growth of approximately 11% to 15% over 2024 [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving self-sustainability and profitability through new product launches and cost-cutting initiatives [10] - The anticipated sale of non-core assets is expected to have a neutral to slightly positive effect on margins and bottom-line metrics [12] Other Important Information - The company has $7 million in cash and cash equivalents, with $27 million in net accounts receivable and $40.1 million in inventory as of June 30, 2025 [17][18] - The anticipated sale of certain assets is expected to close during 2025, with an annual revenue run rate of approximately $23.5 million from the sold businesses [12] Q&A Session Summary Question: Can you clarify the nature of licensing revenue? - Management confirmed that licensing revenue is straightforward and based on sales volume from partners [20] Question: What is the outlook for licensing revenue for the remainder of the year? - Management expects at least another strong quarter but is less confident about Q4 performance [21] Question: What portion of year-over-year growth is driven by new products? - Management indicated that new product introductions, particularly OsteoFactor Pro and Trivium, are expected to contribute positively to growth in the second half of the year [24][26] Question: How should gross margins be viewed for the remainder of the year? - Management anticipates a decline in gross margins by about four to five points due to the effects of royalty revenue and hardware growth decline [30] Question: How will the sale of non-core assets affect the hardware business? - Management believes that divesting non-core assets will allow for greater focus on the domestic hardware business, which is expected to improve performance [32]

Financial Data and Key Metrics Changes - Research and development expenses increased to $20.1 million for Q2 2025 from $15.1 million in Q2 2024, driven by BLA enabling processes and clinical trial activities [53] - General and administrative expenses rose to $8.6 million for Q2 2025 compared to $7.3 million in Q2 2024, primarily due to higher legal and professional fees [53] - Net loss for Q2 2025 was $26.9 million or $0.09 per share, compared to a net loss of $20.9 million or $0.09 per share for Q2 2024 [54] - As of June 30, 2025, the company had $312.8 million in cash and cash equivalents, reflecting gross proceeds of $230 million from a follow-on financing [54][55] Business Line Data and Key Metrics Changes - The REVEAL pivotal trial for TATIA-102 has commenced site activation, with patient enrollment expected to begin in Q4 2025 [11][12] - In the Part A data of the REVEAL trials, all 10 patients treated with TATIA-102 gained or regained one or more developmental milestones, indicating a 100% response rate [15][32] Market Data and Key Metrics Changes - Rett syndrome affects an estimated 15,000 to 20,000 patients across the U.S., Europe, and the UK, highlighting the market potential for TATIA-102 [12][13] Company Strategy and Development Direction - The company aims to redefine the treatment landscape for Rett syndrome with TATIA-102, a gene therapy targeting the genetic root cause of the disease [13][14] - The pivotal trial design focuses on the developmental plateau population, where the likelihood of achieving developmental milestones is approximately zero percent after age six [15][27] - The company has established a two-study approach to generate safety and efficacy data across the broad Rett syndrome population [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made towards the potential registration of TATIA-102, with a clear path forward following alignment with the FDA [11][57] - The company anticipates reporting new supplemental clinical data from Part A of the REVEAL trials in Q4 2025, supporting the therapeutic impacts of TATIA-102 [57] Other Important Information - The company completed a public follow-on offering that extended its cash runway into 2028 [16] - The pivotal trial will evaluate the percentage of patients in the developmental plateau population who gain or regain developmental milestones, with each patient serving as their own control [20][22] Q&A Session Summary Question: Is the 100% response rate for the pivotal trial primary endpoint in Part A the bar for Part B? - Management noted that while the results in Part A are compelling, maintaining a 100% standard is difficult. The statistical plan for Part B will use a null hypothesis of 6.7% for milestone gains, which is significantly lower than the observed results in Part A [59][60] Question: Are there specific time points for milestone occurrences? - Management indicated that improvements are seen over time, with gains typically occurring at most follow-up visits. Some critical gains may not be captured in the milestone assessment but still represent significant improvements in daily functioning [63][66] Question: How does the gene therapy differentiate from competitors? - The company emphasized its unique approach in defining clinical efficacy through meaningful functional gains, supported by a comprehensive natural history dataset. This sets it apart from competitors and aligns with regulatory expectations [69][72] Question: Will there be pushback on using interim readouts for BLA filing? - Management confirmed that the interim analysis approach was discussed with the FDA and is based on robust data from Part A, which supports the primary endpoint at both six and twelve months [79][82] Question: What to expect from the new supplemental REVEAL Part A data in Q4? - Management anticipates sharing additional data points, including video documented milestones and their impact on daily living, at both a medical conference and a company update [84][85]