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Business About Eton Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. We currently have eight commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, KHINDIVI TM , GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. We have five additional product candidates in late-stage development: ET-600, Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. INCRELEX® – This biologic product was approved by the FDA in August 2005 as a treatment for children who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD). The product is approved in 40 territories, including the United States and the European Union. We acquired and launched the product in December 2024.
ALKINDI SPRINKLE® – This product was approved by the FDA in September 2020 as a replacement therapy for Adrenocortical Insufficiency (“AI”) in children under 17 years of age. The product is the first and only FDA-approved granule hydrocortisone formulation designed to help provide accurate dosing for newborns and children with AI. We acquired U.S. marketing rights to the product in March 2020 and launched ALKINDI SPRINKLE® in December 2020 with a sales force targeting pediatric endocrinologists. We believe there are approximately 10,000 children currently suffering from AI in the United States. ALKINDI SPRINKLE® is protected by three issued patents that extend to 2032, 2033, and 2034. KHINDIVI TM – This product was approved by the FDA in May 2025 as a replacement therapy in pediatric patients five years of age and older for adrenocortical insufficiency.
KHINDIVI is the only FDA-approved oral solution formulation of hydrocortisone. It comes in a 1mg/ml strength designed to eliminate the need to split or crush tablets, and to offer simple and accurate dosing specifically tailored to each patient’s needs. It does not require refrigeration, mixing, or shaking – it is a ready-to-use oral liquid solution. KHINDIVI is designed to offer administration simplicity and dosing accuracy, and to provide a therapy option for patients who have difficulty swallowing tablets or with special administration needs, such as patients with a gastric tube. GALZIN® is FDA-approved as a maintenance treatment for patients with Wilson disease who have been initially treated with a chelating agent.
It is estimated that less than 5,000 patients in the U.S. are currently being treated for Wilson disease. We acquired the product in December 2024 and assumed the commercialization of the product in the U.S. in March 2025. We offer the product through our Eton Cares patient support program that provides high-touch, personalized service tailored for rare disease patients and their providers. PKU GOLIKE ® - In March 2024, we acquired the U.S. rights to PKU GOLIKE, which is a next generation medical formula product engineered with the patent protected, pharmaceutical grade Physiomimic™ technology for the dietary management of phenylketonuria (“PKU”) under medical supervision. PKU GOLIKE’s® taste-masked, odor-free coating technology is designed to provide a better taste and a superior experience compared to alternative PKU medical formulas.
In addition, PKU GOLIKE’s delayed amino acid release formulation is designed to keep patients full for a longer period of time. Carglumic Acid Tablets – Our Carglumic Acid product is an FDA-approved generic version of Carbaglu®. Our product is approved for the treatment of acute and chronic hyperammonemia due to N-acetylglutamate synthase (“NAGS”) deficiency . We acquired the marketing rights to the product in October 2021 and launched the product in December 2021. We promote the product with our internal sales force. Betaine Anhydrous for Oral Solution – Our Betaine Anhydrous product is an FDA-approved generic version of Cystadane® for the treatment of homocystinuria, a rare inherited condition that is estimated to impact fewer than 2,000 patients in the United States.
We acquired the product in September 2022 and launched the product in May 2023. Nitisinone – Our Nitisinone product is an FDA-approved generic version of Orfadin® for the treatment of tyrosinemia type 1, an ultra-rare inherited condition that is estimated to impact fewer than 500 patients in the United States. We acquired the product in October 2023 and launched the product in February 2024. ET-600 – In July 2025, ET-600’s NDA was accepted for review by the FDA and assigned a PDUFA target action date of February 25, 2026. The Company has scheduled the production of launch inventory for the first quarter of 2026 in preparation for a commercial launch shortly after the anticipated approval.
The Company recently held an ET-600 advisory meeting with leading healthcare practitioners within the pediatric endocrinology community. […]
Source: 10-K · Period ended December 31, 2025 · View report
Recent company filings, newest first. Excerpts retain the original wording.
Original filing excerpt · Item 8.01
Other Events On September 28, 2026, Eton Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has launched IMPAVIDO® (miltefosine) capsules. The Company has integrated full Eton Cares patient support, including $0 co-pay for eligible commercially insured patients and expanded patient assistance programs. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. 2
View reportOriginal filing excerpt · Item 2.02
Results of Operations and Financial Condition. On August 13, 2026, Eton Pharmaceuticals, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1. The information in this
and the attached Exhibit 99.1 are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this
and the attached exhibit shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended. Discussion of Non-GAAP Financial Measures In the Press Release, we present certain financial information, specifically Adjusted EBITDA, which is not in accordance with generally accepted accounting principles (“U.S. GAAP”). We present Adjusted EBITDA in the Press Release because this metric assists us in comparing our performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance.
Our management uses Adjusted EBITA: ● for planning purposes, including the preparation of our annual operating budget and developing and refining our internal projections for future periods; ● to evaluate the effectiveness of our business strategies and as a supplemental tool in evaluating our performance against our budget for each period; ● in communication with our board of directors and investors concerning our financial performance; ● to evaluate prior acquisitions in relation to the existing business; and ● to evaluate comparative net sales performance in prior and future periods. We believe that the disclosure of Adjusted EBITDA offers an additional financial metric which, when coupled with U.S. GAAP results and the reconciliation to U.S.
GAAP results, provides a more complete understanding of our results of operations and the factors and trends affecting our business for securities analysts, investors and other interested parties in the evaluation of our company. […]
Original filing excerpt · Item 1.01, 2.01
Entry into a Material Definitive Agreement On July 31, 2026, Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) entered into a license agreement (the "Agreement") for a late-stage rare disease product candidate ASN-001 (timolol topical gel) from Auson Pharmaceuticals Inc. ("Auson") for the treatment of proliferating superficial infantile hemangiomas. Under the terms of the Agreement, the Company will pay an upfront license fee to Auson of $3.0 million within thirty days of the Agreement. Additionally, the Company will run a bioavailability bridging study for ASN-001 and, if successful, intends to submit the New Drug Application (NDA) upon completion of the study in the second half of 2027. Upon the successful approval of ASN-001 by the U.S.
Food and Drug Administration ("FDA"), the Company would be responsible for the following milestone payments: ● $5,000,000 upon first commercial sale of product after FDA approval. ● $1,000,000 upon first calendar year in which aggregate annual net sales of product meet or exceed $20,000,000. ● $2,500,000 upon first calendar year in which aggregate annual net sales of product meet or exceed $40,000,000. ● $5,000,000 upon first calendar year in which aggregate annual net sales of product meet or exceed $80,000,000. ● $10,000,000 upon first calendar year in which aggregate annual net sales of product meet or exceed $150,000,000. ● $10,000,000 upon first calendar year in which aggregate annual net sales of product meet or exceed $280,000,000.
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Completion of Acquisition or Disposition of Assets As disclosed in
, on July 31, 2026, the Company entered into a license agreement for a late-stage rare disease product candidate, ASN-001 (timolol topical gel), from Auson for the treatment of proliferating superficial infantile hemangiomas. The information in
Original filing excerpt · Item 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On July 31, 2026, Eton Pharmaceuticals, Inc. (the “Company”) appointed Danka Radosavljevic (age 42) as Chief Operating Officer. Ms. Radosavljevic previously held the position of Executive Vice President, Operations at the Company overseeing quality, product development, regulatory, supply chain and information systems for more than the past five years. Ms. Radosavljevic has been with the Company since 2017.
Ms. Radosavljevic's compensation package includes an annual base salary of $520,800 and an annual discretionary incentive bonus at a total annual target amount of 50% of base salary, based on the achievement of corporate and/or individual performance targets to be determined and approved by the Board of Directors. 2
Original filing excerpt · Item 8.01
Other Events On July 29, 2026, Eton Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the submission of a prior approval supplement to expand the indication of KHINDIVI® (hydrocortisone) oral solution. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. 2
View reportOriginal filing excerpt · Item 5.07
Submission of Matters to a Vote of Security Holders The 2026 Annual Meeting of Stockholders (the “Annual Meeting”) of Eton Pharmaceuticals, Inc. (the “Company”) was held virtually on June 9, 2026. At the meeting, the Company’s stockholders (1) elected the director nominees Jenn Adams and Charles J. Casamento for a three-year term and (2) ratified the appointment of Grant Thornton LLP as the Company’s independent registered public accounting firm for the year ending December 31, 2026. The results for each of the matters voted upon by the Company’s stockholders at the Annual Meeting were as follows: Proposal 1: Election of Directors Nominee For Withheld Broker Non-Votes Jenn Adams 13,370,948 2,149,317 4,664,035 Charles J.
Casamento 9,925,548 5,594,717 4,664,035 Proposal 2: Ratification of the Appointment of Grant Thornton LLP as the Company ’ s Independent Registered Public Accounting Firm for the year ending December 31, 2026 For Against Abstain 16,942,328 3,236,671 5,301 2
Original filing excerpt · Item 1.01, 2.01
Entry into a Material Definitive Agreement On May 18, 2026, Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) entered into a supply and distribution agreement for the United States commercialization rights to IMPAVIDO® (miltefosine) oral capsules with an affiliate of Knight Therapeutics, Inc. (“Supplier”). IMPAVIDO® is an Orphan Drug indicated for the treatment of leishmaniasis, a parasitic disease transmitted by the bite of infected phlebotomine sand flies. Under the terms of the Agreement, the Company will pay the Supplier $4.25 million in fixed fees during the initial term ending March 31, 2032 as follows: ● $125,000 on July 1, 2026 ● $1,250,000 on April 1, 2027 ● $1,000,000 on June 30, 2028 ● $1,000,000 on June 30, 2029 ● $875,000 on June 30, 2030.
After the initial term, the Company shall have the option to make up to ten additional annual renewals subject to certain conditions and an annual fee. The Company would pay up to an additional $4.0 million by making $1.0 million payments when cumulative net sales reach $50.0 million, $100.0 million, $150.0 million and $200.0 million, respectively. The Company will also pay the Supplier 55% of net sales up to $7.0 million per calendar year and 50% of net sales above $7.0 million per calendar year. The Supplier shall be responsible for all product costs and regulatory expenses associated with IMPAVIDO®, and the Company shall be responsible for sales and marketing expenses related to commercialization.
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Completion of Acquisition or Disposition of Assets As disclosed in
, on May 18, 2026, the Company entered into a supply and distribution agreement for the United States commercialization rights to IMPAVIDO® (miltefosine) oral capsules with Supplier. The information in
Original filing excerpt · Item 2.02
Results of Operations and Financial Condition. On May 14, 2026, Eton Pharmaceuticals, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2026. A copy of the press release is attached hereto as Exhibit 99.1. The information in this
and the attached Exhibit 99.1 are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this
and the attached exhibit shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended. Discussion of Non-GAAP Financial Measures In the Press Release, we present certain financial information, specifically Adjusted EBITDA, which is not in accordance with generally accepted accounting principles (“U.S. GAAP”). We present Adjusted EBITDA in the Press Release because this metric assists us in comparing our performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance.
Our management uses Adjusted EBITA: ● for planning purposes, including the preparation of our annual operating budget and developing and refining our internal projections for future periods; ● to evaluate the effectiveness of our business strategies and as a supplemental tool in evaluating our performance against our budget for each period; ● in communication with our board of directors and investors concerning our financial performance; ● to evaluate prior acquisitions in relation to the existing business; and ● to evaluate comparative net sales performance in prior and future periods. We believe that the disclosure of Adjusted EBITDA offers an additional financial metric which, when coupled with U.S. GAAP results and the reconciliation to U.S.
GAAP results, provides a more complete understanding of our results of operations and the factors and trends affecting our business for securities analysts, investors and other interested parties in the evaluation of our company. […]
Original excerpts. Reporting periods, units and comparisons are retained in the text.
Actual results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully consider other matters set forth in our SEC filings, including the Risk Factors set forth in Part I, Item 1A of our 2025 10-K. Overview Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. We currently have eleven commercial rare disease products: INCRELEX®, HEMANGEOL®, ALKINDI SPRINKLE®, KHINDIVI™, DESMODA™, GALZIN®, PKU GOLIKE®, IMPAVIDO®, Carglumic Acid, Betaine Anhydrous and Nitisinone, with IMPAVIDO® scheduled for commercialization in September 2026. We have four additional product candidates in late-stage development: Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. […]
The increase in product sales, net was primarily the result of increased sales of INCRELEX®, GALZIN®, Carglumic Acid and the addition of HEMANGEOL® product sales in the current period. During the six months ended June 30, 2026, we had $61,855 in total revenues that generated a gross profit of $40,148 compared to total revenues of $36,210 during the six-month period ended June 30, 2025 that generated a gross profit of $21,785 for the period. The increase in product sales, net was primarily the result of increased sales of INCRELEX®, GALZIN®, ALKINDI SPRINKLE®, Carglumic Acid and the addition of HEMANGEOL® product sales in the current period. Licensing revenue during the six months ended June 30, 2026 was $0 compared to $3,286 in licensing revenue during the six months ended June 30, 2025.
Liquidity and Capital Resources As of June 30, 2026, we had total assets of $115.8 million, cash and cash equivalents of $26.8 million and working capital of $23.5 million. Cash Flows The following table sets forth a summary of our cash flows for the six-month periods ended June 30, 2026 and 2025 (dollars in thousands): Six months ended Six months ended June 30, 2026 June 30, 2025 Net cash from operating activities $ 14,660 $ 10,049 Cash used in investing activities (15,070 ) — Cash from financing activities 1,313 394 Change in cash and cash equivalents $ 903 $ 10,443 19 During the six months ended June 30, 2026, net cash from operating activities was $14,660 compared to $10,049 during the six months ended June 30, 2025.
This allocation requires management to make significant estimates and assumptions, including the selection of valuation methodologies, discount rates, projected cash flows, and useful lives of acquired assets. Changes in these assumptions could result in materially different allocations of the purchase price, which may impact future depreciation and amortization expense. In addition, because goodwill is not recognized in asset acquisitions, the assignment of value to identifiable intangible assets may be greater than in a business combination. We amortize finite-lived intangible assets over their estimated useful lives and evaluates indefinite-lived assets for impairment. The determination of useful lives and the timing of impairment assessments require significant judgment and may materially affect our results of operations.
Management ’ s Discussion and Analysis of Financial Condition and Results of Operations You should read the following discussion and analysis of our financial condition and results of operations in conjunction with (i) our unaudited interim condensed financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and (ii) our audited financial statements and notes thereto and management ’ s discussion and analysis of financial condition and results of operations Included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (the “ SEC ” ) on March 19, 2026 (the “ 2025 10-K ” ).
Forward-Looking Statements This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 (the “ Exchange Act ” ), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words “ expect, ” “ anticipate, ” “ intend, ” “ believe, ” “ may, ” “ plan, ” “ seek ” or similar language. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Our business and financial performance are subject to substantial risks and uncertainties.
Actual results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully consider other matters set forth in our SEC filings, including the Risk Factors set forth in Part I, Item 1A of our 2025 10-K. Overview Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. We currently have eleven commercial rare disease products: INCRELEX®, HEMANGEOL®, ALKINDI SPRINKLE®, KHINDIVI™, DESMODA™, GALZIN®, PKU GOLIKE®, IMPAVIDO®, Carglumic Acid, Betaine Anhydrous and Nitisinone, with IMPAVIDO® scheduled for commercialization in September 2026. We have four additional product candidates in late-stage development: Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. Results of Operations (dollars in thousands) During the three months ended June 30, 2026, we had $37,589 in total revenues that generated a gross profit of $25,413 compared to total revenues of $18,928 during the three-month period ended June 30, 2025 that generated a gross profit of $11,924 for the period.
The increase in product sales, net was primarily the result of increased sales of INCRELEX®, GALZIN®, Carglumic Acid and the addition of HEMANGEOL® product sales in the current period. During the six months ended June 30, 2026, we had $61,855 in total revenues that generated a gross profit of $40,148 compared to total revenues of $36,210 during the six-month period ended June 30, 2025 that generated a gross profit of $21,785 for the period. The increase in product sales, net was primarily the result of increased sales of INCRELEX®, GALZIN®, ALKINDI SPRINKLE®, Carglumic Acid and the addition of HEMANGEOL® product sales in the current period. Licensing revenue during the six months ended June 30, 2026 was $0 compared to $3,286 in licensing revenue during the six months ended June 30, 2025.
Licensing revenue during the six months ended June 30, 2025 was due to $1,786 from our out-licensing of INCRELEX® rights outside of the U.S. and $1,500 from the recognition of a development milestone event associated with our divestiture of DS-200. Research and Development Expenses During the three months ended June 30, 2026, we incurred $993 of research and development (“R&D”) expenses as compared to $3,712 for the same period in 2025. During the six months ended June 30, 2026, we incurred $2,868 of research and development (“R&D”) expenses as compared to $4,873 for the same period in 2025. In 2025, the Company paid a $2,155 NDA filing fee for DESMODA™, which was approved by the FDA in February of 2026.
General and Administrative Expenses G&A expenses consist primarily of employee compensation expenses, legal and professional fees, product marketing expenses, FDA fees, distribution expenses, business insurance, travel expenses, and general office expenses. During the three-month periods ended June 30, 2026 and 2025, we incurred $11,626 and $9,687, respectively, of G&A expenses. During the six-month periods ended June 30, 2026 and 2025, we incurred $22,072 and $18,857, respectively, of G&A expenses. […]
Risk Factors We operate in a dynamic and rapidly changing environment that involves numerous risks and uncertainties. Certain factors may have a material adverse effect on our business, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to consider the following discussion of risk factors, in its entirety, in addition to other information contained in this Annual Report on Form 10-K and our other public filings with the SEC. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our results of operations and financial condition. Risks Relating to Pricing, Reimbursement and Market Access The Inflation Reduction Act and related Medicare reforms may adversely affect the prices we realize and the demand for our products.
The Inflation Reduction Act of 2022 (the “IRA”), and related federal and state healthcare reforms, have introduced new and evolving mechanisms that may affect the prices we realize for our products and the demand for our products over time. These mechanisms include, among others, inflation-based rebates under Medicare Parts B and D that can require payments when certain reported prices increase faster than inflation; changes to the Medicare Part D benefit beginning in 2025 that redistribute financial liability among manufacturers, plans and the government while capping patient out-of-pocket costs; and a program under which certain drugs may become subject to price negotiation on a defined timetable. The applicability and impact of these mechanisms will evolve over time based on our portfolio mix and the characteristics of individual products.
For example, whether and when a product becomes subject to the Medicare drug price negotiation program depends, among other factors, on the time elapsed since FDA approval and other selection criteria, and inflation‑based rebates in Medicare Parts B and D apply when prices increase faster than inflation. Changes in our portfolio, utilization and payer mix could therefore alter our exposure to negotiation, inflation‑based rebates, and the redesigned Medicare Part D benefit, including our financial responsibility under the new benefit structure. Implementation will occur through ongoing regulatory actions, the outcomes of which remain uncertain. Even where our current products are not immediately selected for negotiation or have limited Medicare utilization, these changes may alter channel economics, increase our obligations, reduce the net prices we realize, and adversely affect patient access and demand.
Certain statutory exemptions may apply to particular products based on their indications, approval history or other factors; however, exemptions are narrow and can change with future legislation, guidance or changes in our product portfolio. The IRA, its implementing regulations and related guidance continue to evolve, and the scope and timing of their impact on our business remains uncertain. Our participation in U.S. government price reporting and discount programs imposes complex and evolving obligations that could adversely affect the net prices we realize and expose us to significant liabilities. Our participation in U.S. government price reporting and discount programs materially affects the net prices we realize and requires us to comply with complex and evolving legal and reporting obligations.
For example, under the Medicaid Drug Rebate Program, we must calculate and report Average Manufacturer Price (“AMP”) and, where applicable, Best Price, and pay rebates to states. Recalculations or restatements—whether due to errors, new interpretations, government audits or other factors—can be retroactive and may require us to pay additional rebates. These obligations can also affect pricing and refund requirements under the 340B Drug Pricing Program, including through recalculation of ceiling prices and controls intended to prevent duplicate discounts. In addition, our products may be subject to pricing and discount requirements under the U.S. Department of Veterans Affairs and Federal Supply Schedule programs, including obligations tied to Non-Federal Average Manufacturer Price (“Non-FAMP”), Federal Ceiling Price (“FCP”) and related certifications, as well as TRICARE rebate requirements.
Government authorities continue to increase scrutiny of these programs, and noncompliance (including inaccurate reporting, failure to timely report changes, or failure to implement required controls) may result in significant refunds, civil monetary penalties, contractual damages, suspension or termination from participation in government programs, reputational harm, and potential liability under the False Claims Act. Third-party coverage and reimbursement and healthcare cost containment initiatives, including formulary controls and utilization management, may constrain our future revenues. Our ability to successfully commercialize our products and product candidates depends in significant part on the extent to which governmental authorities, commercial insurers and other third-party payors provide coverage for, and establish adequate reimbursement levels for, our products.
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The quarterly report's own risk disclosure is shown below. No changes have been inferred by comparing reports.
Risk Factors We operate in a dynamic and rapidly changing environment that involves numerous risks and uncertainties. Certain factors may have a material adverse effect on our business, financial condition, and results of operations, and you should carefully consider them. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our results of operations and financial condition. You should carefully consider the factors discussed in Part I, Item 1A. “Risk Factors” in our 2025 10-K, which could materially affect our business, financial condition, cash flows or future results. The risk factors described in our 2025 10-K, are not the only risks facing our company.
Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, or future results.
Only the extracted annual management discussion is evaluated using dictionary version 1.1. Score = (positive − negative) ÷ matched terms × 100. Quarterly reports and current filings are excluded. This lexical measure does not assess financial health and may not fully capture context or negation.
Management ’ s Discussion and Analysis of Financial Condition and Results of Operations You should read the following discussion and analysis together with our financial statements and the related notes thereto included in “ Item 8. Financial Statements and Supplementary Data ” in this Annual Report on Form 10-K. The following discussion contains forward-looking statements that involve risks and uncertainties. For a complete discussion of forward-looking statements, see the section above entitled “ Forward Looking Statements. ” Our actual results could differ materially from those expressed or implied in any forward-looking statements as a result of various factors, including those set forth under the caption “ Item 1A. Risk Factors.
” Overview Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. We currently have eight commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, KHINDIVI TM , GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous and Nitisinone. We have five additional product candidates in late-stage development: ET-600, Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. Results of Operations Year Ended December 31, 2025 Compared to Year Ended December 31, 2024 During the twelve months ended December 31, 2025, we had $80.0 million in total revenues that generated a gross profit of $42.7 million, compared to total revenues of $39.0 million during the twelve-months ended December 31, 2024 that generated a gross profit of $23.4 million during the period.
During the twelve-months ended December 31, 2025, we had product sales and royalties, net of $76.7 million, compared to product sales and royalties, net of $38.5 million during the twelve-months ended December 31, 2024, an increase of $38.2 million. The increase in product sales and royalties, net was the result of increased sales volume of our INCRELEX®, ALKINDI SPRINKLE® and GALZIN® products in the current year. Licensing revenue during the twelve-months ended December 31, 2025 was $3.3 million, compared to $0.5 million in licensing revenue during the twelve-months ended December 31, 2024. The increase in licensing revenue during the twelve-months December 31, 2025 was due to $1.8 million from our out-licensing of INCRELEX® rights outside of the U.S. and $1.5 million from the recognition of a development milestone event associated with our divestiture of DS-200.
During the twelve-months ended December 31, 2024, we recognized $0.5 million in licensing revenue associated with the sale of our DS-200 product candidate in September 2024. Cost of Sales During the twelve-months ended December 31, 2025, total costs of sales was $37.2 million, compared to $15.6 million in total costs of sales during the twelve-months ended December 31, 2024. The increase in total costs of sales during the twelve-months December 31, 2025, was due to increases in INCRELEX® and ALKINDI SPRINKLE® product sales and higher commissions with respect to our out-licensing of INCRELEX® rights outside of the U.S. Gross profit during the twelve-months ended December 31, 2025 was $42.7 million or 53.5% as a percentage of total net revenues, compared to gross profit of $23.4 million or 60.0% as a percentage of total net revenues during the twelve-months ended December 31, 2024.
The decrease in gross profit during the twelve-months ended December 31, 2025 was primarily attributable to higher commission with respect to our out-licensing of INCRELEX® rights outside of the U.S. Research and Development Expenses We currently have twelve employees that support our overall product development function. The majority of our spend in research and development (“R&D”) expenses is to third parties we contract with to develop, test our products and the development of partner milestone payments. During the twelve-months ended December 31, 2025, we incurred $7.8 million of R&D expenses, compared to $3.3 million during the twelve-months ended December 31, 2024. The increase in R&D expenses was primarily due to a $2.2 million NDA filing fee for ET-600 and increased expenses associated with our ET-700 and ET-800 project development activities.
33 General and Administrative Expenses General and administrative expenses (“G&A”) expenses consist primarily of employee compensation expenses, selling and advertising/promotional expenses, legal and professional fees, business insurance and FDA fees associated with approved products. We anticipate that our G&A expenses will increase to support our business growth, particularly with respect to sales and marketing activities and additional personnel. During the twelve-months ended December 31, 2025 and 2024, we incurred $35.8 million and $22.8 million, respectively, of G&A expenses. […]