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 ...

Q1 2025 revenue of $17.3 million, with product sales of $14.0 million, representing 76% growth over Q1 2024 and the 17th straight quarter of sequential product sales growthQ1 2025 basic and fully diluted GAAP EPS of $(0.06), Non-GAAP fully diluted EPS of $0.07, and Adjusted EBITDA of $3.7 millionRelaunched pediatric endocrinology biologic INCRELEX® in the U.S. and out-licensed international rightsEstablished Wilson disease franchise with the acquisition and relaunch of GALZIN® (zinc acetate) capsules and th ...

DEER PARK, Ill., May 01, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report first quarter 2025 financial results on Tuesday, May 13, 2025. Management will host a conference call and live audio webcast to discuss the results at 4:30 p.m. ET (3:30 p.m. CT). Dial In* (Audio Only) Click Here Webcast: Click Here In addition to t ...

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]

Esteve Pharmaceuticals, S.A. will commercialize Increlex in all markets outside the U.S. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has six additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, ET- 70 ...

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]

Group 1: Financial Performance - Eton Pharmaceuticals reported a quarterly loss of $0.02 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.09 per share a year ago [1] - The company posted revenues of $11.65 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 9.05%, and up from $7.31 million year-over-year [2] - The current consensus EPS estimate for the upcoming quarter is $0.04 on revenues of $14.31 million, and for the current fiscal year, it is $0.50 on revenues of $84.16 million [7] Group 2: Market Performance and Outlook - Eton Pharmaceuticals shares have increased by approximately 14.8% since the beginning of the year, while the S&P 500 has declined by 3.5% [3] - The company has a favorable estimate revisions trend, resulting in a Zacks Rank 2 (Buy), indicating expected outperformance in the near future [6] - The Medical - Biomedical and Genetics industry is currently in the top 28% of Zacks industries, suggesting a positive outlook for stocks within this sector [8]