Financial Data and Key Metrics Changes - Net revenue for Q1 2026 was $13.9 million, down from $16.6 million in the prior year, but excluding a one-time rebate benefit from last year, net revenue increased by 5% [17][21] - ADHD portfolio net revenue was $13.2 million compared to $15.3 million in the prior year, but on an equivalent basis, it increased by about 10% [17][21] - Gross margin decreased to 66% from 72% year-over-year, but improved to 65% when excluding the rebate [18][21] - Operating expenses were $10.2 million, down from $11.2 million in the prior year, reflecting cost reduction efforts [19][21] Business Line Data and Key Metrics Changes - The ADHD portfolio showed resilience with a 10% increase in net revenue on an equivalent basis, despite a decrease in total prescriptions [17][21] - The pediatric portfolio revenue dropped to $0.7 million from $1.3 million due to manufacturing delays and a de-emphasis in marketing [18][21] Market Data and Key Metrics Changes - The company is preparing for the launch of Exxua, which is expected to significantly impact the market for major depressive disorder treatments [5][10] - The ADHD market remains highly genericized, but the company believes its unique distribution model will mitigate the impact of generic competition [12][13] Company Strategy and Development Direction - The company is focused on the successful launch of Exxua, with significant preparations underway including KOL engagement and Salesforce training [5][10] - Aytu is maintaining a Salesforce of approximately 40 people, with territory alignments adjusted for optimal market access [8][9] - The company is also working on lifecycle management approaches to extend exclusivity beyond 2030 [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ADHD portfolio's resilience despite the threat of generic competition, citing the unique distribution model [12][13] - The company anticipates a strong launch for Exxua, with positive feedback from prescribers and a focus on targeting younger patients dissatisfied with current treatments [27][44] Other Important Information - The FDA's recent communication regarding fluoride-containing drugs is being monitored, but the impact on Aytu's financials is expected to be minimal [15][16] - Cash and cash equivalents were $32.6 million at the end of the quarter, up from $31 million [22] Q&A Session Summary Question: How significant were the territory realignments and what are the plans for incentive compensation post-Exxua launch? - Approximately one-third of the territories were affected, with a focus on enhancing coverage in key areas. A rich incentive compensation plan is being finalized to reward engagement with new prescribers [30][31] Question: What has been done regarding payer engagement pre-launch? - The company is taking a cautious approach to contracting with commercial payers to maintain best pricing on government contracts, with light engagement ongoing [33][35] Question: How much of the target prescriber market has been reached and what feedback has been received? - Feedback from engaged prescribers has been overwhelmingly positive, with a focus on targeting psychiatrists already familiar with Aytu's products [40][41] Question: What is the flexibility of the supply chain to ramp up production if demand exceeds expectations? - The company has sufficient supply to meet initial forecasts and can scale production as needed, with a low cost of goods sold projected [49][51]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $165 million, a slight decrease from $168 million in the same quarter last year [15] - Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for Q2 2025 increased by 17% compared to the same quarter last year [15] - GAAP net earnings for Q2 2025 were $22 million or $0.40 per diluted share, compared to $20 million or $0.36 per diluted share in the same quarter last year [16] - As of June 30, 2025, the company had approximately $523 million in cash, cash equivalents, and marketable securities, up from $454 million as of December 31, 2024 [20] Business Line Data and Key Metrics Changes - KELBY had a robust performance with a 23% growth in prescriptions and a 31% growth in net sales [7] - GOCOVRI saw a 14% increase in prescriptions and a 16% increase in net sales compared to the same quarter last year [9] - ONAPCO launched successfully with over 750 patient enrollment forms submitted by more than 300 prescribers [10] - ZERZUVEY reported net revenues of $23.2 million in Q2 2025, up from $13.8 million in Q2 2024, representing a 68% increase [11] Market Data and Key Metrics Changes - KELBY's adult business prescriptions increased by 29% in Q2 2025 compared to the same period last year, reaching 35% of total KELBY prescriptions [8] - GOCOVRI's Medicare prescriptions had a copay of less than $25 for 97% of cases, up from 77% in 2024 [9] Company Strategy and Development Direction - The company is transitioning from legacy products to a new growth phase with the addition of ZERZUVEY and the launch of ONAPCO [6][11] - Corporate development will focus on revenue-generating products and potential M&A opportunities, particularly in the women's health sector [12][50] Management's Comments on Operating Environment and Future Outlook - Management expects 2025 to be a turning point for accelerated growth, with total revenue guidance updated to $670 million to $700 million [21] - The company anticipates an operating loss of $70 million to $80 million for the full year 2025, primarily due to acquisition-related costs [22] Other Important Information - The acquisition of Sage Therapeutics was completed on July 31, 2025, which is expected to enhance mid to long-term revenue growth [11] - The company maintains a strong balance sheet with no debt, providing financial flexibility for future growth opportunities [20] Q&A Session Summary Question: Can you discuss the net pricing dynamics for KELBY and the adult segment's launch progress? - Management indicated that net pricing remains above $300 per prescription, with adult prescriptions growing by 29% [28][30] Question: What is the status of ONAPCO's enrollment and reimbursement? - Management reported over 750 enrollment forms submitted and smooth reimbursement processes, with over 200 patients currently receiving the product [31][35] Question: Were there any one-time events driving ZERZUVEY's sales growth? - Management noted a 36% growth in prescriptions for ZERZUVEY, attributing it to strong brand momentum and sales force expansion [39] Question: How does the company plan to balance investments in OBGYN and psychiatry? - Management stated that 70% to 80% of prescriptions are generated by OBGYNs, and they will explore opportunities in both areas with Biogen [56] Question: What is the commercial infrastructure for ZERZUVEY in postpartum depression? - Management refrained from providing specific details about the sales force and infrastructure until discussions with Biogen are completed [66]

Financial Data and Key Metrics Changes - Consolidated shipments decreased by 7% to 2,700,000 units, with declines in North America and large Europe, partially offset by growth in South America and the Middle East and Africa [10] - Net revenue fell by 13% to €74 billion, impacted by adverse regional mix and lower pricing [10] - Adjusted diluted earnings per share and industrial free cash flow showed improvement compared to 2024, despite an outflow of €3 billion in the first half [11][12] - AOI margin was compressed to 70 basis points, reflecting a significant increase in industrial costs [13] Business Line Data and Key Metrics Changes - North America and Europe are in turnaround phases, while South America and Middle East and Africa are delivering consistent results [15] - In North America, performance was affected by tariffs and lower fleet performance, while Europe saw a 13% decline in LCV volumes [16] - South America maintained market share leadership, with industry growth in Brazil and Argentina [16] Market Data and Key Metrics Changes - North America and Europe are experiencing a recovery, with North America showing a 90% year-over-year improvement in order books [34] - European market share increased to 17%, up 1.3 percentage points from H2 2024, with significant growth in BEV and hybrid vehicle sales [35][36] Company Strategy and Development Direction - The company is focusing on growth, execution, and profitability, with a lineup of new vehicles and powertrains [24] - Key actions include launching new products, improving inventory discipline, and reestablishing financial guidance for the second half of 2025 [19][20] - The leadership team is committed to making tough decisions to accelerate business recovery [20] Management's Comments on Operating Environment and Future Outlook - The first half of 2025 was challenging, but there are signs of improvement, with expectations for gradual sequential acceleration in the second half [19][40] - The company is addressing past mistakes by reintroducing successful nameplates and adjusting product strategies to meet customer demand [73] Other Important Information - Industrial liquidity at the end of H1 was €47 billion, with €31 billion in cash and liquid securities [17] - The expected net tariff expense for the year is projected to be around €1.5 billion due to increased production levels [18] Q&A Session Summary Question: Focus on U.S. Market and Profitability Improvement - Management emphasized growth in North America through new product launches and optimizing the mix between ICE and electrified models [45] Question: Cash Flow and Balance Sheet Strength - Management acknowledged high cash burn but noted a significant reduction and expected further improvement in the second half [54] Question: Brand Portfolio Strategy - Management recognized the strength of their iconic brand portfolio and is working on better management and efficiency [60] Question: Pricing Pressure in Europe - Management indicated that market share is improving, and they expect better profit generation in H2 despite industry challenges [66] Question: Relationship with U.S. Dealers - Management reported improved dialogue with dealers, resulting in a 90% year-over-year increase in order inflow [85] Question: Guidance on Free Cash Flow - Management expressed commitment to gradual improvement in cash flow, with expectations for increased volumes and better pricing in the second half [92]

Summary of Glaukos (GKOS) 2025 Conference Call Company Overview - **Company**: Glaukos Corporation (GKOS) - **Event**: 2025 Conference Call held on May 27, 2025 Key Points on iDose Reimbursement and Performance - **Reimbursement Status**: Progress is being made with Medicare administrators, including Noridian, Novitas, and First Coast, with increasing payments for the drug and facility fees [2][3][10] - **Professional Fee Adjudication**: Ongoing efforts to streamline professional fee payments, with some Medicare Administrative Contractors (MACs) showing signs of improvement [3][5] - **Volume Generation**: The timing of reimbursement progress is tied to generating procedural volumes, which is critical for establishing a systematic reimbursement process [4][5] - **ASP Comparison**: iDose's Average Selling Price (ASP) is competitive, with the product containing seven times the amount of drug compared to Darista, which has comprehensive coverage across payers [7][9][10] - **Coverage Status**: Approximately 50% of lives are covered under commercial plans and Medicare Advantage, with ongoing efforts to expand access [10][11] - **Market Dynamics**: iDose is positioned as a second or third-line therapy initially, with plans to drive it closer to first-line therapy over time [12] Financial Performance and Projections - **Q1 2025 Performance**: The company reported exceptional progress in the market, with Noridian fully operational and increasing payments from Novitas and First Coast [14][19] - **Sales Guidance**: For 2025, the guidance for iDose sales is projected between $120 million to $125 million, with expectations for a stronger second half of the year due to seasonality and backlog building [23][24] - **Gradual Launch**: The launch of iDose is expected to be gradual and methodical, with a focus on education and operationalizing reimbursement processes [37][39] Long-term Outlook - **Peak Sales Estimates**: Peak sales expectations for iDose have not changed significantly but have increased on a risk-adjusted basis due to positive real-world performance [45] - **Market Potential**: The company is optimistic about the long-term market opportunity, with a focus on expanding access and operational efficiency in physician offices [42][44] U.S. Stent Business Insights - **Recent Performance**: The U.S. stent business experienced mid-single-digit growth in early 2024 but faced challenges due to Local Coverage Determinations (LCDs) impacting procedures [47][48] - **Guidance Adjustments**: Guidance for 2025 has been adjusted to reflect the impact of LCDs, with expectations for recovery as awareness and adaptation to these changes improve [52][54] Profitability Goals - **Cash Flow Breakeven**: The company aims to achieve free cash flow breakeven in the near term while continuing to make necessary investments [56] Additional Notes - **Investor Enthusiasm**: There is strong enthusiasm from investors regarding the product's clinical performance, but the launch pace is primarily influenced by reimbursement dynamics [31][35] - **Education and Support**: The company emphasizes the importance of educating physicians and their staff on the procedural aspects and reimbursement processes to ensure successful adoption [29][30]