Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $18,900,000, representing a remarkable 108% increase compared to $9,100,000 in Q2 2024 [34] - Adjusted EBITDA for Q2 2025 was $3,100,000, compared to a negative $1,600,000 in Q2 2024 [39] - The company generated $8,000,000 of cash flow from operations during the quarter [32][40] Business Line Data and Key Metrics Changes - The growth in revenue was primarily driven by increased sales of Alkindi, along with the addition of Incrolex and Galzin, which were not included in the prior year period [34] - Incrolex exceeded expectations, achieving a goal of 100 active patients five months ahead of schedule [9] - Alkindi Sprinkle continued to show robust growth, generating more new scripts than any other six-month period in its history [20] Market Data and Key Metrics Changes - The company expects to achieve an $80,000,000 annual revenue run rate in 2025, one quarter ahead of previous projections [34] - The potential market for Incrolex could grow significantly if the FDA harmonizes the definitions of severe primary IGF-1 deficiency between the US and EU [15] Company Strategy and Development Direction - The company is focused on product launches and acquisitions, with three product launches planned for 2025 and a strong pipeline of innovative candidates [31][33] - The strategy includes addressing unmet needs in pediatric endocrinology and rare diseases, with a commitment to profitability [32][33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's performance, highlighting record product sales and significant revenue growth [6][32] - The company is confident in its ability to continue growing its patient base and revenue, particularly with the upcoming product launches [20][30] Other Important Information - The company has more than $30,000,000 in cash on hand, providing a strong financial position for future acquisitions [31][40] - The FDA has accepted the NDA submission for ET600, with a target action date set for February 2026 [29] Q&A Session Summary Question: Can you discuss the momentum seen in the early stages of the Candivy launch? - Management noted that some physicians are converting patients aged five and above to Candivy, with expectations to exceed $50,000,000 in combined sales with Alkindi [46][47] Question: What kind of trial design was discussed with the FDA regarding Incralex? - Management indicated plans to open an IND for patients with IGF levels between minus two and minus three standard deviations, allowing for ongoing data collection [50][52] Question: Can you clarify the sources of revenue growth across Incrolex, Galzin, and Alkindi? - Management confirmed that Incrolex led the way in revenue growth, with contributions from Alkindi and Galzin as well [55] Question: What are the expectations for the back half of the year regarding operational expenses? - Management expects a significant ramp down in operational expenses as the major product launches are behind them [64] Question: How quickly can the new formulation for Candivy be approved? - Management anticipates submitting the revised formulation for FDA approval by the end of next year, which could significantly increase patient numbers [70]