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 [38] - 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 [39] - Adjusted gross profit was $12 million, or 69.5% of total revenue, compared to $5.2 million or 65.6% in the prior year [40] - Adjusted EBITDA for Q1 2025 was $3.7 million, compared to $500,000 in Q1 2024 [43] - The net loss for the quarter was $1.6 million, compared to a net loss of $800,000 in the prior year [44] 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 a rapid increase in active patients, reaching over 90, with a goal of 100 by the end of the year [8] - Galzin, a treatment for Wilson's disease, has been relaunched with a $0 copay program, improving access for patients [22] Market Data and Key Metrics Changes - The company is focusing on pediatric endocrinology, leveraging its existing sales force and commercial infrastructure to drive growth [6] - The market for ET400, an upcoming product, is estimated to have around 5,000 adrenal insufficiency patients under nine years of age, presenting a significant opportunity [17] Company Strategy and Development Direction - The company aims to expand its product portfolio through acquisitions and licensing, focusing on ultra-rare diseases [32] - The strategy includes harmonizing U.S. and EU labels for Incralyx to expand treatment opportunities significantly [12] - The company is preparing for the launch of ET400, with a PDUFA date approaching, and expects to generate substantial revenue from this product [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, expecting to exit 2025 with an annual revenue run rate of approximately $80 million [39] - The company is optimistic about the upcoming product launches and the potential for significant revenue growth from its pipeline [33] - Management noted that the tariff situation would have minimal impact on the company, as most products are produced in the U.S. [34] Other Important Information - The company has made significant investments in infrastructure to support growth, including a dedicated metabolic sales team [42] - The company expects to maintain adjusted gross margins of approximately 70% for the full year 2025 and exceed 75% by 2028 [40] 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 [46] Question: Recent interactions with FDA regarding ET400 - The company has received feedback on labeling discussions and believes it is on track for approval within two weeks [48] Question: Weekly Incralyx prescription trends - The company has significantly increased the number of patients and expects to provide further updates on prescription trends in the coming months [58] Question: Expected timing for commercial revenue from ET400 - The company anticipates a launch around the approval date, likely in Q3, with a gradual revenue uptake thereafter [61] Question: Feedback on Galzin relaunch - The relaunch has been well-received, with a zero copay program and improved access for patients, leading to steady patient additions [72]

Financial Performance - Total net revenues for the three months ended March 31, 2025, were $17,282,000, a significant increase of 117.9% compared to $7,966,000 for the same period in 2024[11] - Gross profit for the three months ended March 31, 2025, was $9,861,000, compared to $5,007,000 for the same period in 2024, reflecting a gross margin improvement[11] - The net loss for the three months ended March 31, 2025, was $1,572,000, compared to a net loss of $811,000 for the same period in 2024, resulting in a net loss per share of $0.06[11] - Adjusted EBITDA for the three months ended March 31, 2025, was $3,675, a significant increase from $482 in the same period of 2024[158] - Non-GAAP net income for the three months ended March 31, 2025, was $2,395, compared to $244 in the same period of 2024, reflecting improved operational performance[158] Cash and Assets - Cash and cash equivalents increased to $17,420,000 as of March 31, 2025, from $14,936,000 at the beginning of the period[21] - Total current assets increased to $49,960,000 as of March 31, 2025, compared to $41,021,000 as of December 31, 2024[9] - As of March 31, 2025, total assets were $84.0 million, with cash and cash equivalents of $17.4 million and working capital of $24.6 million[153] Liabilities and Expenses - Total liabilities increased to $59,582,000 as of March 31, 2025, compared to $51,695,000 as of December 31, 2024, reflecting increased operational costs[9] - Research and development expenses for the three months ended March 31, 2025, were $1,161,000, up from $651,000 in the same period of 2024, indicating increased investment in product development[11] - General and administrative expenses rose to $9,170 for the three months ended March 31, 2025, from $5,156 in the same period of 2024, attributed to increased advertising, product development, and headcount[151] Revenue Sources - For the three months ended March 31, 2025, AnovoRx product sales represented 90.8% of net product revenues, down from 97.7% in the same period of 2024[32] - Product sales and royalties, net, increased by $6,030 to $13,996 for the three months ended March 31, 2025, driven by higher sales of INCRELEX®, ALKINDI SPRINKLE®, and Carglumic Acid[148] - Licensing revenue for the three months ended March 31, 2025, was $3,286, compared to zero in the same period of 2024, due to out-licensing of INCRELEX® rights and a development milestone recognition[149] Stock and Compensation - The total stock-based compensation expense for the three months ended March 31, 2025, was $1,200,000, an increase from $821,000 in the same period of 2024[102] - Stock-based compensation related to Restricted Stock Units (RSUs) was $190,000 for the three months ended March 31, 2025, compared to $60,000 in 2024[108] - The Company recorded an expense of $81,000 related to the Employee Stock Purchase Plan (ESPP) for the three months ended March 31, 2025[111] Product Development and Pipeline - The company has seven commercial rare disease products and six additional product candidates in late-stage development, indicating ongoing expansion in its product pipeline[20] - The Company expects to submit an NDA for ET-600 to the FDA, with a potential approval and launch in Q1 2026[143] Risk and Compliance - The Company relies on a small number of suppliers for key chemicals and products, which poses a risk of significant interruption in the manufacturing process[53] - The Company operates in a dynamic environment with various risks that could materially affect its financial condition and results[193] - There have been no changes in internal control over financial reporting that materially affected the Company during the reporting period[189] Tax and Interest - The income tax expense for the three months ended March 31, 2025, was $74,000, while there was no income tax expense in the same period of 2024[116] - The effective tax rate for the three months ended March 31, 2025, was (4.9%), compared to 0.0% for the same period in 2024[117] - The Company recorded interest expense of $1,163 for the three months ended March 31, 2025, compared to $238 for the same period in 2024[92]

Exhibit 99.1 "We are now less than one month away from a potential launch of ET-400. We have been actively engaged with the FDA as part of the ongoing review, and we remain prepared to launch quickly upon potential approval on its Prescription Drug User Fee Act (PDUFA) date of May 28th. With three expected product launches this year and several late-stage candidates progressing in development, 2025 is shaping up to be another monumental year for Eton as we further solidify our place as a leading ultra-rare ...

Core Insights - Eton Pharmaceuticals reported exceptional first-quarter results for 2025, achieving record financial performance and launching two recently acquired products, INCRELEX and GALZIN, while advancing its development pipeline [2][4][11]. Financial Performance - Eton's first-quarter 2025 net revenues reached $17.3 million, a 117% increase from $8.0 million in the same period last year, with product sales of $14.0 million reflecting a 76% growth [11][12]. - The company reported a gross profit of $9.9 million, up 97% from $5.0 million year-over-year, driven by increased product sales [13]. - Adjusted EBITDA for the first quarter was $3.7 million, compared to $0.5 million in the prior year [18]. Product Developments - The relaunch of INCRELEX, a treatment for Severe Primary IGF-1 Deficiency, has seen a significant increase in new patients since its acquisition and relaunch [5][12]. - Eton is preparing for the anticipated launch of ET-400, targeting a $200 million market opportunity for oral hydrocortisone, with a PDUFA date set for May 28, 2025 [6][12]. - The company also relaunched GALZIN for Wilson disease and announced the development of ET-700, an extended-release form of zinc acetate [7][12]. Licensing and Partnerships - Eton out-licensed the commercial rights to INCRELEX outside the U.S. to Esteve Pharmaceuticals for up to ten years, receiving a $4.3 million upfront licensing fee [8][9]. - The licensing revenue recognized during the first quarter included $1.8 million from this out-licensing agreement [11]. Cash Position and Expenses - As of March 31, 2025, Eton had cash and cash equivalents of $17.4 million, with an operating cash flow of $2.1 million generated during the quarter [21]. - Research and Development (R&D) expenses increased to $1.2 million from $0.7 million year-over-year, primarily due to the development of ET-700 and ET-800 [15]. General and Administrative (G&A) expenses rose to $9.2 million, reflecting increased advertising and promotional costs [17].

Core Viewpoint - Eton Pharmaceuticals, Inc. will report its first quarter 2025 financial results on May 13, 2025, and will host a conference call to discuss these results [1]. Company Overview - Eton Pharmaceuticals is focused on developing and commercializing treatments for rare diseases, currently offering seven commercial products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone [3]. - The company has six additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector [3]. Investor Relations - Investors can submit questions via email to investorrelations@etonpharma.com during the conference call [1]. - The live webcast of the conference call will be accessible on Eton's website, with an archived version available for 30 days post-event [2].

Eton Pharmaceuticals, Inc. (ETON) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, ...

Core Points - Eton Pharmaceuticals has submitted a New Drug Application (NDA) for ET-600, an oral solution of desmopressin for treating central diabetes insipidus, with a 10-month FDA review expected and a potential launch in Q1 2026 [1][2] - If approved, ET-600 will be the only FDA-approved oral liquid formulation of desmopressin, addressing the needs of approximately 3,000 pediatric patients in the U.S. [2] - Eton holds a patent for ET-600 that expires in 2044, with additional patent applications under review [2] - The company has seven commercial rare disease products and six additional product candidates in late-stage development [3]

Core Insights - Eton Pharmaceuticals has out-licensed the commercial rights to Increlex® to Esteve Pharmaceuticals for markets outside the U.S. [1][2] - Esteve is expected to leverage its global infrastructure to successfully commercialize Increlex, allowing Eton to focus on growth opportunities within the U.S. [2][3] - The licensing agreement is for up to ten years, with an option for Esteve to acquire international rights in the future [3] Company Overview - Eton Pharmaceuticals specializes in developing and commercializing treatments for rare diseases, currently offering seven commercial products and six additional candidates in late-stage development [4]

Core Insights - CROSSJECT has announced positive updates regarding its collaboration with ETON PHARMACEUTICALS for the ZENEO® adrenal insufficiency program, particularly focusing on the development of ZENEO® Hydrocortisone for the US and Canadian markets [3][4][5] Company Developments - CROSSJECT has developed a proprietary ready-to-use liquid formulation of hydrocortisone, which simplifies the administration process compared to existing products like PFIZER's Solu-Cortef® that require over ten steps for preparation [4] - ETON will commercialize the CROSSJECT Formulation, referred to as ET-800, and CROSSJECT will receive a high single-digit royalty on ETON's net sales [4][9] - ETON anticipates capturing a significant share of the hospital market for hydrocortisone injectables, estimated at $100 million, with future evaluations suggesting the market opportunity could exceed $200 million in the US alone [4][5][9] Future Outlook - ETON has confirmed its commitment to the ZENEO® Hydrocortisone project, with development and manufacturing milestones expected to commence from early 2026 [5][9] - CROSSJECT is also focused on accelerating the development of its products for adrenal insufficiency in the US and plans to leverage its experience to introduce innovative solutions in Europe and globally [6]

Financial Data and Key Metrics Changes - The fourth quarter of 2024 saw record revenue of $11.6 million, representing a year-over-year increase of 59% [35] - Gross profit increased by 78% year-over-year, despite negative impacts from stepped-up inventory values and increased IP amortization [36] - Operating income for the quarter was a positive $600,000, with SG&A expenses rising to $6.7 million due to one-time transaction costs and investments in commercial infrastructure [38] Business Line Data and Key Metrics Changes - The company has achieved sixteen consecutive quarters of product revenue growth since launching Alcindi Sprinkle, with expectations for continued growth from newly acquired products Acrolex and Galzum [17][31] - The IncraLex acquisition contributed less than $200,000 to Q4 revenue, while Galzum closed on December 31 and did not materially impact Q4 results [36] Market Data and Key Metrics Changes - The company targets ultra-rare diseases, with all conditions currently addressed by its products having fewer than 10,000 patients in the U.S., and many with even fewer than 1,000 [11] - The potential patient population for IncraLex could expand significantly if the FDA adopts a broader definition of severe primary IGF-1 deficiency, potentially increasing the U.S. patient population from 200 to approximately 1,000 [72] Company Strategy and Development Direction - The company aims to build a leading ultra-rare disease company through a three-pillar growth strategy: organic growth of existing products, development of internal pipeline programs, and external acquisitions [16] - Recent acquisitions of Acrolex and Galzum are expected to have significant immediate impacts on revenue in 2025, alongside the development of late-stage pipeline assets [14][31] - The company is focused on enhancing patient access and affordability through its Eton Cares program, which includes zero-dollar copays and free drug programs for uninsured patients [10][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching $100 million in revenue in the near term, driven by the integration of new products and a robust pipeline [31] - The company anticipates significant growth opportunities in the adrenal insufficiency franchise and Wilson disease treatment, with plans for new product launches and market education initiatives [79][115] Other Important Information - The company has established strong relationships with pediatric endocrinology and metabolic genetics communities, enhancing its competitive edge in launching new therapies [24] - The company has a broad ultra-rare disease portfolio, with thirteen approved or late-stage products, seven of which are currently commercial [29] Q&A Session Summary Question: What are the growth prospects for IncraLex? - Management highlighted the potential to increase the patient population significantly if the FDA harmonizes the U.S. and European labels, which could expand the market opportunity to over $250 million annually [77] Question: How does the company plan to address the challenges faced by Wilson disease patients? - The company plans to improve access and affordability through its Eton Cares program and aims to increase awareness and education about the benefits of its FDA-approved product over OTC alternatives [126][120] Question: What is the expected impact of ET400 on the adrenal insufficiency market? - Management expects ET400 to capture a significant portion of the market, addressing the needs of patients who prefer liquid formulations and potentially reducing discontinuation rates [88][104]