Company Performance - Eton Pharmaceuticals reported quarterly earnings of $0.07 per share, missing the Zacks Consensus Estimate of $0.09 per share, compared to a loss of $0.03 per share a year ago, representing an earnings surprise of -22.22% [1] - The company posted revenues of $17.28 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 6.71%, and this is an increase from year-ago revenues of $7.97 million [2] - Over the last four quarters, Eton Pharmaceuticals has surpassed consensus revenue estimates three times [2] Stock Performance - Eton Pharmaceuticals shares have increased approximately 30.3% since the beginning of the year, while the S&P 500 has declined by -0.6% [3] - The current consensus EPS estimate for the coming quarter is $0.07 on revenues of $16.7 million, and for the current fiscal year, it is $0.53 on revenues of $75.35 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Eton Pharmaceuticals belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

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]

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]