Financial Data and Key Metrics Changes - Third quarter product revenue was $22.5 million, an increase of 129% year-over-year and up 19% compared to the second quarter, marking the 19th consecutive quarter of sequential product revenue growth [4][25] - Adjusted EBITDA for the third quarter was $2.9 million, compared to $2.0 million in the prior year period [29] - The company reported a net loss of $1.9 million for the quarter, compared to net income of $0.6 million in the prior year period [29] Business Line Data and Key Metrics Changes - Alkindi Sprinkle and Coagadex drove strong year-over-year growth, alongside contributions from recently acquired products Increlex and Galzin [4] - Increlex's revenue and patient count continue to exceed original projections, with a net active patient count remaining around 100 [6][8] - Galzin now has over 200 active patients, surpassing the original year-end target for 2025 [16] Market Data and Key Metrics Changes - The company experienced a less favorable payer mix in the third quarter, resulting in lower revenue per patient compared to the second quarter [26] - The company expects U.S. product sales to continue to grow sequentially in the fourth quarter compared to the third quarter, despite some non-recurring revenue from Increlex-related sales [26] Company Strategy and Development Direction - Eton is focused on expanding its product portfolio through strategic acquisitions, with $37 million in cash available for financing [23] - The company aims to harmonize the U.S. and EU definitions of severe primary IGF-1 deficiency to potentially increase the Increlex market opportunity fivefold [11] - Eton plans to launch ET-600, an oral solution for treating central diabetes insipidus, with a PDUFA date set for February 25, 2026 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth opportunities for Increlex, Alkindi, and Kindivi, with expectations for continued strong revenue growth [24] - The company anticipates significant growth in 2026, driven by product launches and pipeline developments [24] Other Important Information - Adjusted gross profit was $10.2 million in the third quarter, representing an adjusted gross margin of 45%, impacted by Increlex ex-U.S.-related costs [27] - The company generated $12 million in cash from operations during the quarter [5][30] Q&A Session Summary Question: Can you provide pro-forma gross margins for the core U.S. business excluding non-recurring revenue? - Adjusted gross margins without Increlex ex-U.S. activity would be over 70% for the quarter [31] Question: What are the drivers behind the sequential revenue growth for Alkindi? - The focus of the sales force on pediatric endocrinology and increased physician comfort with the product are key drivers [32] Question: What is the status of the Increlex U.S. registry? - The registry will take place at U.S. sites, separate from those in the global registry [36] Question: What is the company's approach to business development opportunities? - The company is in late-stage discussions for two ultra-rare disease products and expects to close transactions soon [38] Question: What are the reasons for patient discontinuation on Increlex? - Discontinuation is primarily due to patients aging out, which is expected and normal [40]

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]

Financial Data and Key Metrics Changes - The company's first quarter revenue was $17.3 million, a 117% increase from $8 million in the first quarter of 2024 [35] - Product sales reached $14 million, up 76% from $8 million in the prior year, driven by increased sales of Alkindi Sprinkle and the addition of Incralyx [36] - Adjusted gross profit was $12 million, or 69.5% of total revenue, compared to $5.2 million or 65.6% in the prior year [36] - Adjusted EBITDA for the first quarter was $3.7 million, compared to $500,000 in the prior year [39] - The company reported a net loss of $1.6 million for the quarter, compared to a net loss of $800,000 in the prior year [40] Business Line Data and Key Metrics Changes - Alkindi Sprinkle has shown strong growth for 17 consecutive quarters, with an increase in new patient referrals in 2025 [15] - Incralyx has seen rapid patient acquisition, reaching over 90 active patients shortly after its relaunch, with expectations to reach 100 by year-end [8][12] - Galzin, acquired for Wilson's disease treatment, is expected to generate significant revenue as the company addresses access and affordability issues [21][22] Market Data and Key Metrics Changes - The company is focusing on pediatric endocrinology, leveraging its existing sales force and infrastructure to drive growth in this segment [6][15] - The market for severe primary IGF-1 deficiency is estimated to have around 200 patients in the U.S., with potential for significant growth through increased awareness and screening [6][12] - The Wilson disease market is estimated to impact approximately 10,000 people in the U.S., with only about 2,000 diagnosed and treated, indicating a substantial unmet need [19][20] Company Strategy and Development Direction - The company aims to become a leading player in the ultra-rare disease market, with a strong focus on product launches and pipeline development [30][31] - The strategy includes harmonizing U.S. and EU labels for Incralyx to expand treatment opportunities significantly [10][12] - The company is also advancing new product candidates like ET-700 and ET-800, targeting unmet needs in rare disease treatments [24][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, expecting to exit 2025 with an annual revenue run rate of approximately $80 million [36] - The management team is optimistic about the upcoming product launches and the potential for significant revenue growth from the pipeline [31] - The company is not concerned about tariff impacts, as most products are produced domestically, and any European purchases represent less than 5% of forecasted revenue [33][34] Other Important Information - The company has made significant investments in infrastructure to support growth, including a dedicated metabolic sales team and commercial activities for product relaunches [37][38] - The company expects to maintain adjusted gross margins of approximately 70% for the full year 2025, with long-term goals exceeding 75% by 2028 [36] Q&A Session Summary Question: Update on Incralyx FDA meeting - The meeting request has been submitted, with expectations for a follow-up in July and a submission for label change in Q3 [42] Question: Recent interactions with FDA regarding ET-400 - The company is on track for approval within two weeks, with final labeling discussions underway [44] Question: Weekly Incralyx prescription trends - The company has significantly increased the number of patients, with expectations to exceed revenue goals this year [54][55] Question: Expected timing for ET-400 commercial revenue - The launch is anticipated around June, with revenue expected to ramp up in Q3 [56][57] Question: Commentary on tariff risk exposure - The company does not foresee a meaningful impact from tariff proposals, as it primarily sells domestically [60][62] Question: Feedback on Galzin relaunch - The relaunch has been well-received, with a strong patient uptake and zero copay for patients [68][70]

Financial Data and Key Metrics Changes - The company's first quarter revenue was $17.3 million, a 117% increase compared to $8 million in the first quarter of 2024 [37] - Product sales reached $14 million, up 76% from $8 million in the same quarter last year, driven by increased sales of Alkindi Sprinkle and the addition of Incralyx [38] - Adjusted gross profit was $12 million, or 69.5% of total revenue, compared to $5.2 million or 65.6% in the prior year [39] - Adjusted EBITDA for the first quarter was $3.7 million, compared to $500,000 in the prior year [43] - The total net loss was $1.6 million, compared to a net loss of $800,000 in the prior year [43] Business Line Data and Key Metrics Changes - The acquisition and relaunch of Incralyx and Dalzan contributed to strong growth in existing products [6] - Alkindi Sprinkle has shown consistent growth for 17 consecutive quarters, with an increase in new patient referrals in 2025 [16] - The company expects to reach approximately 80,000,000 annual revenue run rate by the end of 2025 [38] Market Data and Key Metrics Changes - The company is focusing on pediatric endocrinology, leveraging its existing sales force and commercial infrastructure to raise awareness of severe primary IGF-1 deficiency [8] - The market for ET400 is estimated to have around 5,000 adrenal insufficiency patients under nine years of age, presenting a compelling opportunity [18] Company Strategy and Development Direction - The company aims to become a leading player in the ultra-rare disease market, with a focus on expanding its product portfolio through acquisitions and licensing [31] - The strategy includes harmonizing U.S. and EU labels for Incralyx to expand treatment opportunities significantly [13] - The company is also developing ET700, an extended-release version of Galzin, to address dosing challenges and improve patient outcomes [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of existing products and the potential for new product approvals in the near future [6] - The company is optimistic about the upcoming launch of ET400, expecting rapid uptake and significant revenue impact in subsequent quarters [60] - Management noted that the tariff situation is not a major concern, as most products are produced in the U.S. and the impact of European purchases is minimal [34][35] Other Important Information - The company has made significant investments in infrastructure to support growth, including a dedicated metabolic sales team and commercial activities for product relaunches [41] - The company reported a cash balance of $17.4 million and generated $2.1 million in operating cash flow during the quarter [43] Q&A Session Summary Question: Update on Incralyx label expansion meeting with FDA - The meeting request has been submitted, and the company expects to have it in the coming weeks, likely in July [45] Question: Recent interactions with FDA regarding ET400 - The company is on track for approval within two weeks, with the final step being labeling discussions [47] Question: Weekly Incralyx prescription trends - The company has significantly increased the number of patients and expects to meet or exceed revenue goals this year [56] Question: Expected timing for commercial revenue from ET400 - The launch is expected around the approval date, with revenue anticipated in Q3 [59] Question: Feedback on Galzin relaunch - The relaunch has been well-received, with a strong uptake and zero copay for patients, improving access significantly [70]