Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On March 19, 2026, Eton Pharmaceuticals, Inc. issued a press release announcing its financial results for the fourth quarter and twelve months ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Item 2.02 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 Item 2.02 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.
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:
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. We believe Adjusted EBITDA is useful to investors for the following reasons:
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Exhibit 99.1
Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results
| |
●
|
Q4 2025 product sales of $21.3 million, representing 83% growth over Q4 2024
|
| |
●
|
Q4 2025 basic GAAP EPS of $0.06, fully diluted GAAP EPS of $0.05, basic non-GAAP EPS of $0.21, fully diluted non-GAAP EPS of $0.19, and Adjusted EBITDA of $6.2 million
|
| |
●
|
Launched DESMODA™, the first and only FDA-approved desmopressin oral solution
|
| |
●
|
Licensed U.S. rights to Orphan Drug HEMANGEOL®; expected to be accretive to 2026 earnings
|
| |
●
|
Company expects full year 2026 revenue to exceed $110 million with an Adjusted EBITDA margin of over 30%
|
| |
●
|
Management to hold conference call today at 4:30pm ET
|
DEER PARK, Ill., March 19, 2026 (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 reported financial results for the quarter ended December 31, 2025.
“It was another phenomenal quarter for Eton with meaningful contributions from key products across our portfolio including INCRELEX, ALKINDI SPRINKLE, KHINDIVI, and GALZIN. The strong fourth quarter helped us cap off a transformational 2025. During the year we launched three major products, INCRELEX, GALZIN, and KHINDIVI, and delivered $80 million in total revenue, more than doubling our 2024 revenue,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
“The recent FDA approval of DESMODA and the acquisition of HEMANGEOL have further accelerated our 2026 growth trajectory. DESMODA’s approval was highly anticipated by the endocrinology community, and the product received a very strong reception in its first week of launch. Our commercial team is fired up and fully mobilized, executing on the launch plan. Our entire team is also hard at work on the integration of HEMANGEOL and eager for our scheduled May 1st relaunch. Both of these products will be key growth contributors in 2026 and beyond. In addition, this year is poised to be our most active year yet on the clinical front, with key studies initiating or already initiated for the INCRELEX label expansion, the KHINDIVI reformulation, ET-700, and AMGLIDIA.”
“We are poised for another year of record financial results in 2026. For the full year, we expect to see revenue exceed $110 million and at least a 30% Adjusted EBITDA margin,” concluded Brynjelsen.
Fourth Quarter and Recent Business Highlights
83% growth in product sales year-over-year. Eton reported fourth quarter 2025 product sales of $21.3 million, compared to $11.6 million in the prior year period, driven primarily by strong growth in ALKINDI SPRINKLE and the addition of revenues from INCRELEX, GALZIN, and KHINDIVI.
Commercial launch of DESMODA. Eton launched DESMODA on March 9th, leveraging its existing team of pediatric endocrinology rare disease specialists. The product has received a strong reception from the patient and healthcare professional community, and numerous patients have already started on treatment. DESMODA is expected to significantly contribute to the Company’s long-term growth, with potential peak sales of $30-50 million annually.
Acquired U.S. rights to Orphan Drug HEMANGEOL. The acquisition establishes a third call point for Eton’s sales team, pediatric dermatology. Eton anticipates integrating the product into its rare disease commercial infrastructure and extending its best-in-class Eton Cares patient support program to all HEMANGEOL patients, which includes the $0 co-pay for all commercially insured patients. Eton will begin commercializing HEMANGEOL on May 1st. The transaction was financed with cash on hand and is expected to be accretive to 2026 earnings.
Advancement of INCRELEX label harmonization study. In December, the company held a Type C meeting with the FDA to discuss the clinical pathway required to expand the U.S. FDA definition of Severe Primary IGF-1 Deficiency (SPIGFD) to match the broader E.U. definition. The Company believes the meeting was positive, and as a result, Eton submitted the proposed final study protocol to the FDA in February. The Company expects FDA feedback on the protocol by the end of March. If cleared, Eton would proceed with study initiation, with the goal of dosing the first patient in the third quarter of 2026.
Continued strong GALZIN growth, now exceeding 300 active patients. GALZIN growth continued to trend ahead of forecast in the fourth quarter of 2025 and so far in the first quarter of 2026. The Company’s targeted investment in rare disease specialists and education has increased awareness, access, and adoption and, earlier this month, the Company eclipsed 300 active patients on therapy. Eton continues to see a large growth opportunity to expand the treated population through conversion of patients currently taking over-the-counter products that are not FDA approved for Wilson disease.
Planned ET-700 pilot study. ET-700, the Company’s extended-release formulation of zinc acetate, will be tested in a proof-of-concept positron emission tomography (PET) study that is expected to initiate in April. The study will compare ET-700 to GALZIN and a placebo. If successful, the study would support the initiation of a dose ranging and pivotal study in early 2027.
Initiation of bioequivalence study to support KHINDIVI label expansion. The Company has initiated the bioequivalence study required to support submission of Eton’s revised KHINDIVI formulation designed to expand the product’s approved indication beyond its current restriction of children ages five and older. The study has been initiated, with the first patient dosed last week. The Company expects to receive preliminary top-line results late in the second quarter and receive the final study report needed for submission of the supplement in the third quarter of 2026. The Company anticipates a 10-month review for the submission, leading to a potential mid-2027 approval.
2026 Financial Guidance
The Company expects 2026 revenues to exceed $110 million with an Adjusted EBITDA margin of at least 30%.
Fourth Quarter Financial Results
Net Revenue: Net revenues for the fourth quarter of 2025 were $21.3 million compared to $11.6 million in the prior year period, an increase of 83%. The growth was driven primarily by increased sales of ALKINDI SPRINKLE and the addition of sales from INCRELEX, GALZIN, and KHINDIVI.
Gross Profit: Gross profit for the fourth quarter of 2025 was $13.1 million compared to $6.5 million in the prior year period, an increase of 102%, driven by the increase in revenues.
Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was $15.5 million in the fourth quarter of 2025, representing an adjusted gross margin of 73% compared to adjusted gross profit of $6.8 million and adjusted gross margin of 59% in the prior year period.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $1.8 million compared to $(0.9) million in the prior year period, due primarily to increased expenses associated with the Company’s pipeline development activities. In addition, during the fourth quarter of 2024, Eton’s ET-400 product was granted Orphan Drug Designation by the FDA, which resulted in Eton receiving a refund of the NDA filing fee that was paid and expensed in a prior quarter.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2025 were $8.9 million compared to $6.7 million in the prior year period, due primarily to an increase in product advertising and launch-year promotional expenses, higher stock-based compensation expense, and an increase in compensation and benefit expenses due to an increase in general and administrative headcount.
Adjusted G&A expense, which removes share-based compensation, transaction-related costs, and other one-time expenses, was $7.8 million in the quarter, compared to $5.8 million the prior year period.
The fourth quarter of 2025 included $0.9 million of annual FDA Program Fees related to the company’s approved New Drug Applications. Historically, Eton qualified for a waiver of annual fees for its Orphan Designated products, however, as of October 1, 2025, the Company’s revenue level was above the waiver threshold, and it began paying the fees.
Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA): Adjusted EBITDA for the fourth quarter of 2025 was $6.2 million compared to $2.1 million in the prior year period, an increase of 195%.
Net Income/Loss: Net income for the fourth quarter of 2025 was $1.5 million or $0.05 per diluted share compared to a net loss of $5.4 million or $0.02 per basic and diluted share in the prior year period.
On a non-GAAP basis, the Company reported net income of $5.4 million or $0.19 per diluted share, for the fourth quarter of 2025 compared to net income of $0.7 million, or $0.02 per diluted share in the prior year period.
For a reconciliation of GAAP net loss to Earnings Before Interest, Taxes, Depreciation and Amortization EBITDA (“EBITDA”), Adjusted EBITDA and Adjusted Non-GAAP basic and fully diluted earnings per share to the most directly comparable GAAP financial measure, please see the tables below.
Cash Position: As of December 31, 2025, the Company had cash and cash equivalents of $25.9 million.
Conference Call and Webcast Information
As previously announced, Eton Pharmaceuticals will host its fourth quarter 2025 conference call as follows:
| Date: |
March 19, 2026 |
| |
|
| Time: |
4:30 p.m. ET (3:30 p.m. CT) |
| |
|
| Participant Webcast Link: |
Click Here |
| |
|
| Participant Call Link: |
Click Here |
In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: investorrelations@etonpharma.com.
The live webcast can be accessed on the Investors section of Eton’s website at https://ir.etonpharma.com/. An archived webcast will be available on Eton’s website approximately two hours after the completion of the event and for 30 days thereafter.
* Conference call participants should register to obtain their dial-in and passcode details. Please be sure to register using a valid email address.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has ten commercial rare disease products: KHINDIVIM, INCRELEX®, ALKINDI SPRINKLE®, DESMODA™, GALZIN®, HEMANGEOL®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Non-GAAP Financial Measures
In addition to the Company’s results of operations determined in accordance with U.S. generally accepted accounting principles (GAAP), which are presented and discussed above, management also utilizes Adjusted EBITDA, an unaudited financial measure that is not calculated in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted EBITDA is considered a “non-GAAP” financial measure within the meaning of Regulation G promulgated by the SEC. Management believes that this non-GAAP financial measure reflects an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results, provides a more complete understanding of the Company’s results of operations and the factors and trends affecting its business. Management believes Adjusted EBITDA provides meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the way they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.
Adjusted EBITDA
The Company defines Adjusted EBITDA as net loss, excluding the effects of stock-based compensation and expenses, interest, taxes, depreciation, amortization, investment loss, net, and, if any and when specified, other non-recurring income or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net loss. Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net loss as a measure of operating performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Eton Pharmaceuticals, Inc.
Statements of Operations
(In thousands, except per share amounts)
| |
|
For the three months ended
|
|
|
For the years ended
|
|
| |
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
| |
|
2025
|
|
|
2024
|
|
|
2025
|
|
|
2024
|
|
|
Revenues:
|
|
(Unaudited)
|
|
|
(Audited)
|
|
|
Licensing revenue
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
3,286 |
|
|
$ |
500 |
|
|
Product sales and royalties, net
|
|
|
21,281 |
|
|
|
11,647 |
|
|
|
76,664 |
|
|
|
38,511 |
|
|
Total net revenues
|
|
|
21,281 |
|
|
|
11,647 |
|
|
|
79,950 |
|
|
|
39,011 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing revenue
|
|
|
— |
|
|
|
— |
|
|
|
825 |
|
|
|
270 |
|
|
Product sales and royalties
|
|
|
8,181 |
|
|
|
5,171 |
|
|
|
36,385 |
|
|
|
15,330 |
|
|
Total cost of sales
|
|
|
8,181 |
|
|
|
5,171 |
|
|
|
37,210 |
|
|
|
15,600 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
13,100 |
|
|
|
6,476 |
|
|
|
42,740 |
|
|
|
23,411 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (1)
|
|
|
1,780 |
|
|
|
(871 |
) |
|
|
7,765 |
|
|
|
3,255 |
|
|
General and administrative
|
|
|
8,856 |
|
|
|
6,718 |
|
|
|
35,819 |
|
|
|
22,753 |
|
|
Total operating expenses
|
|
|
10,636 |
|
|
|
5,847 |
|
|
|
43,584 |
|
|
|
26,008 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
2,464 |
|
|
|
629 |
|
|
|
(844 |
) |
|
|
(2,597 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other expense, net
|
|
|
(1,050 |
) |
|
|
(1,140 |
) |
|
|
(3,714 |
) |
|
|
(1,211 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax expense
|
|
|
1,414 |
|
|
|
(511 |
) |
|
|
(4,558 |
) |
|
|
(3,808 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax (benefit) expense
|
|
|
(69 |
) |
|
|
87 |
|
|
|
43 |
|
|
|
15 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$ |
1,483 |
|
|
$ |
(598 |
) |
|
$ |
(4,601 |
) |
|
$ |
(3,823 |
) |
|
Net income (loss) per share, basic and diluted
|
|
$ |
0.06 |
|
|
$ |
(0.02 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.15 |
) |
|
Weighted average number of common shares outstanding, basic and diluted
|
|
|
26,937 |
|
|
|
26,135 |
|
|
|
26,908 |
|
|
|
25,895 |
|
|
Net income (loss) per share, diluted
|
|
$ |
0.05 |
|
|
$ |
(0.02 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.15 |
) |
|
Weighted average number of common shares outstanding, diluted
|
|
|
31,243 |
|
|
|
26,135 |
|
|
|
26,908 |
|
|
|
25,895 |
|
| (1) |
During the three months ended December 31, 2024, we received $2,024 from the FDA associated with an approved PDUFA exemption and corresponding refund for a previously paid NDA filing fee. |
Eton Pharmaceuticals, Inc.
Balance Sheets
(In thousands, except share and per share amounts)
(Audited)
| |
|
December 31, 2025
|
|
|
December 31, 2024
|
|
| |
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
25,942 |
|
|
$ |
14,936 |
|
|
Accounts receivable, net
|
|
|
11,757 |
|
|
|
5,361 |
|
|
Inventories, net
|
|
|
15,419 |
|
|
|
15,232 |
|
|
Prepaid expenses and other current assets
|
|
|
7,463 |
|
|
|
5,492 |
|
|
Total current assets
|
|
|
60,581 |
|
|
|
41,021 |
|
| |
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
326 |
|
|
|
34 |
|
|
Intangible assets, net
|
|
|
30,878 |
|
|
|
34,881 |
|
|
Operating lease right-of-use assets, net
|
|
|
310 |
|
|
|
175 |
|
|
Other long-term assets, net
|
|
|
19 |
|
|
|
12 |
|
|
Total assets
|
|
$ |
92,114 |
|
|
$ |
76,123 |
|
| |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
10,976 |
|
|
$ |
4,167 |
|
|
Short-term debt, net of discount
|
|
|
8,789 |
|
|
|
— |
|
|
Accrued Medicaid rebates
|
|
|
9,317 |
|
|
|
6,866 |
|
|
Accrued liabilities
|
|
|
9,408 |
|
|
|
8,914 |
|
|
Total current liabilities
|
|
|
38,490 |
|
|
|
19,947 |
|
| |
|
|
|
|
|
|
|
|
|
Long-term debt, net of discount and including accrued fees
|
|
|
21,769 |
|
|
|
29,811 |
|
|
Operating lease liabilities, net of current portion
|
|
|
460 |
|
|
|
107 |
|
|
Other long-term liabilities
|
|
|
5,241 |
|
|
|
1,830 |
|
|
Total liabilities
|
|
|
65,960 |
|
|
|
51,695 |
|
| |
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
Stockholders’ equity
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 50,000,000 shares authorized; 27,047,061 and 26,709,084 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively
|
|
|
27 |
|
|
|
27 |
|
|
Additional paid-in capital
|
|
|
138,621 |
|
|
|
132,294 |
|
|
Accumulated deficit
|
|
|
(112,494 |
) |
|
|
(107,893 |
) |
|
Total stockholders’ equity
|
|
|
26,154 |
|
|
|
24,428 |
|
| |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
$ |
92,114 |
|
|
$ |
76,123 |
|
Eton Pharmaceuticals, Inc.
Statements of Cash Flows
(In thousands)
(Audited)
| |
|
For the years ended
|
|
| |
|
December 31, 2025
|
|
|
December 31, 2024
|
|
|
Cash flows from (used in) operating activities
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(4,601 |
) |
|
$ |
(3,823 |
) |
| |
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash from operating activities:
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
5,512 |
|
|
|
3,165 |
|
|
Depreciation and amortization
|
|
|
4,044 |
|
|
|
1,146 |
|
|
Inventory step-up
|
|
|
5,094 |
|
|
|
— |
|
|
Excess and obsolete inventory reserve
|
|
|
594 |
|
|
|
529 |
|
|
Debt discount amortization
|
|
|
696 |
|
|
|
1,109 |
|
|
Non-cash lease expense
|
|
|
44 |
|
|
|
70 |
|
|
Changes in operating assets and liabilities, net of impact of business acquisition:
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(6,396 |
) |
|
|
(3,118 |
) |
|
Inventories
|
|
|
(5,876 |
) |
|
|
(1,839 |
) |
|
Prepaid expenses and other assets
|
|
|
(1,971 |
) |
|
|
(3,349 |
) |
|
Accounts payable
|
|
|
6,808 |
|
|
|
2,318 |
|
|
Accrued Medicaid rebates
|
|
|
2,451 |
|
|
|
3,239 |
|
|
Accrued liabilities
|
|
|
1,011 |
|
|
|
1,484 |
|
|
Other non-current assets and liabilities
|
|
|
3,114 |
|
|
|
38 |
|
| |
|
|
10,524 |
|
|
|
969 |
|
| |
|
|
|
|
|
|
|
|
|
Cash flows from (used in) investing activities
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(333 |
) |
|
|
(26 |
) |
|
Acquisition of business
|
|
|
— |
|
|
|
(30,000 |
) |
|
Purchase of product licensing rights
|
|
|
— |
|
|
|
(9,988 |
) |
|
Net cash from (used in) investing activities
|
|
|
(333 |
) |
|
|
(40,014 |
) |
| |
|
|
|
|
|
|
|
|
|
Cash flows from (used in) financing activities
|
|
|
|
|
|
|
|
|
|
Net proceeds from the issuance of long-term debt
|
|
|
— |
|
|
|
25,309 |
|
|
Repayment of long-term debt
|
|
|
— |
|
|
|
(1,155 |
) |
|
Common stock issued in private placement offering
|
|
|
— |
|
|
|
7,000 |
|
|
Proceeds from stock option exercises
|
|
|
598 |
|
|
|
1,191 |
|
|
Employee stock purchase plan
|
|
|
217 |
|
|
|
248 |
|
|
Net cash from (used in) financing activities
|
|
|
815 |
|
|
|
32,593 |
|
| |
|
|
|
|
|
|
|
|
|
Change in cash and cash equivalents
|
|
|
11,006 |
|
|
|
(6,452 |
) |
|
Cash and cash equivalents at beginning of period
|
|
|
14,936 |
|
|
|
21,388 |
|
|
Cash and cash equivalents at end of period
|
|
$ |
25,942 |
|
|
$ |
14,936 |
|
| |
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$ |
3,325 |
|
|
$ |
665 |
|
|
Cash paid for income taxes
|
|
$ |
118 |
|
|
$ |
82 |
|
Eton Pharmaceuticals, Inc.
Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation
(in thousands, except per share amounts)
(Unaudited)
| |
|
For the three months ended
|
|
|
For the years ended
|
|
| |
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
| |
|
2025
|
|
|
2024
|
|
|
2025
|
|
|
2024
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income (loss)
|
|
$ |
1,483 |
|
|
$ |
(598 |
) |
|
$ |
(4,601 |
) |
|
$ |
(3,823 |
) |
|
Depreciation
|
|
|
17 |
|
|
|
12 |
|
|
|
41 |
|
|
|
50 |
|
|
Intangible amortization expense
|
|
|
1,000 |
|
|
|
343 |
|
|
|
4,003 |
|
|
|
1,096 |
|
|
Interest expense (including debt discount amortization and non-cash interest expenses)
|
|
|
1,208 |
|
|
|
1,333 |
|
|
|
4,781 |
|
|
|
2,005 |
|
|
Income tax expense (benefit)
|
|
|
(69 |
) |
|
|
87 |
|
|
|
43 |
|
|
|
15 |
|
|
EBITDA
|
|
$ |
3,639 |
|
|
$ |
1,177 |
|
|
$ |
4,267 |
|
|
$ |
(657 |
) |
|
Other non-GAAP adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory step-up expense (1)
|
|
|
1,421 |
|
|
|
— |
|
|
|
5,094 |
|
|
|
— |
|
|
Stock-based compensation (2)
|
|
|
1,124 |
|
|
|
782 |
|
|
|
5,512 |
|
|
|
3,165 |
|
|
Severance expense (3)
|
|
|
— |
|
|
|
— |
|
|
|
335 |
|
|
|
— |
|
|
Acquisition/divestiture-related costs (4)
|
|
|
7
|
|
|
|
140 |
|
|
|
581 |
|
|
|
415 |
|
|
Total of Other non-GAAP adjustments
|
|
|
2,552 |
|
|
|
922 |
|
|
|
11,522 |
|
|
|
3,580 |
|
|
Adjusted EBITDA
|
|
$ |
6,191 |
|
|
$ |
2,099 |
|
|
$ |
15,789 |
|
|
$ |
2,923 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP income (loss) before income tax
|
|
$ |
1,414 |
|
|
$ |
(511 |
) |
|
$ |
(4,558 |
) |
|
$ |
(3,808 |
) |
|
Non-GAAP adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation (5)
|
|
|
17 |
|
|
|
12 |
|
|
|
41 |
|
|
|
50 |
|
|
Intangible amortization expense (6)
|
|
|
1,000 |
|
|
|
343 |
|
|
|
4,003 |
|
|
|
1,096 |
|
|
Inventory step-up expense (1)
|
|
|
1,421 |
|
|
|
- |
|
|
|
5,094 |
|
|
|
- |
|
|
Share-based compensation (2)
|
|
|
1,124 |
|
|
|
782 |
|
|
|
5,512 |
|
|
|
3,165 |
|
|
Severance expense (3)
|
|
|
— |
|
|
|
— |
|
|
|
335 |
|
|
|
— |
|
|
Acquisition/divestiture-related costs (4)
|
|
|
7 |
|
|
|
140 |
|
|
|
581 |
|
|
|
415 |
|
|
Total pre-tax non-GAAP adjustments
|
|
|
3,569 |
|
|
|
1,277 |
|
|
|
15,566 |
|
|
|
4,726 |
|
|
Income tax effect of pre-tax non-GAAP adjustments (7)
|
|
|
(372 |
) |
|
|
94 |
|
|
|
235 |
|
|
|
49 |
|
|
Total non-GAAP adjustments
|
|
|
3,941 |
|
|
|
1,183 |
|
|
|
15,331 |
|
|
|
4,677 |
|
|
Non-GAAP Net Income
|
|
$ |
5,355 |
|
|
$ |
672 |
|
|
$ |
10,773 |
|
|
$ |
869 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, basic
|
|
|
26,937 |
|
|
|
26,135 |
|
|
|
26,908 |
|
|
|
25,895 |
|
|
Weighted average number of common shares outstanding, diluted
|
|
|
31,243 |
|
|
|
29,320 |
|
|
|
31,046 |
|
|
|
27,458 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP income (loss) per share - Basic
|
|
$ |
0.06 |
|
|
$ |
(0.02 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.15 |
) |
|
Non-GAAP adjustments
|
|
|
0.15 |
|
|
|
0.05 |
|
|
|
0.57 |
|
|
|
0.18 |
|
|
Non-GAAP earnings per share - Basic
|
|
$ |
0.21 |
|
|
$ |
0.03 |
|
|
$ |
0.40 |
|
|
$ |
0.03 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP income (loss) per share - Basic
|
|
$ |
0.06 |
|
|
$ |
(0.02 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.15 |
) |
|
Non-GAAP adjustments
|
|
|
0.13 |
|
|
|
0.04 |
|
|
|
0.49 |
|
|
|
0.17 |
|
|
Non-GAAP earnings per share - Diluted
|
|
$ |
0.19 |
|
|
$ |
0.02 |
|
|
$ |
0.32 |
|
|
$ |
0.02 |
|
|
(1)
|
During the twelve months ended December 31, 2025, we recognized in cost of sales $5,094 for inventory step-up expense primarily attributable to INCRELEX® inventory revalued in connection with this business combination. |
|
(2)
|
Represents share-based compensation expense associated with our stock option and restricted stock unit stock unit grants to our employees and non-employee directors and our employee share purchase plan. |
|
(3)
|
Represents severance and benefit expenses associated with role redundancy within commercial operations during the first quarter of 2025. |
|
(4)
|
Represents legal expense and other divestiture-related costs associated with the out-licensing of the INCRELEX® commercial rights in territories outside of the U.S. |
|
(5)
|
Represents depreciation expense related to our property and equipment. |
|
(6)
|
Intangible amortization expenses are associated with our intellectual property rights related to INCRELEX®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous and Nitisinone. |
|
(7)
|
Income tax adjustments on pre-tax non-GAAP adjustments represent the estimated income tax impact of each pre-tax non-GAAP adjustment based on the effective income tax rate for the period. We are in a full income tax valuation allowance position and the income tax effect on pre-tax non-GAAP adjustments is commensurate with the performance measure.
|
Eton Pharmaceuticals, Inc.
Fourth Quarter 2025 GAAP to Non-GAAP Net Income (Loss) Reconciliation
(in thousands)
(Unaudited)
|
Fourth Quarter 2025
|
|
GAAP
|
|
|
Depreciation and Intangible Amortization
|
|
|
Inventory Step-Up Expense
|
|
|
Stock Based Compensation
|
|
|
Severance Expense
|
|
|
Acquisition/ Divestiture Related Costs
|
|
|
Non-GAAP
|
|
|
Cost of sales
|
|
$ |
8,181 |
|
|
|
(1,000 |
) |
|
|
(1,421 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
5,760 |
|
|
Research and development
|
|
|
1,780 |
|
|
|
- |
|
|
|
- |
|
|
|
(62 |
) |
|
|
- |
|
|
|
- |
|
|
|
1,718 |
|
|
General and administrative
|
|
|
8,856 |
|
|
|
(17 |
) |
|
|
- |
|
|
|
(1,062 |
) |
|
|
- |
|
|
|
(7 |
) |
|
|
7,770 |
|
|
Interest and other expense, net
|
|
|
(1,050 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,050 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth Quarter 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
$ |
5,171 |
|
|
|
(343 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
4,828 |
|
|
Research and development
|
|
|
(871 |
) |
|
|
- |
|
|
|
- |
|
|
|
(31 |
) |
|
|
- |
|
|
|
- |
|
|
|
(902 |
) |
|
General and administrative
|
|
|
6,718 |
|
|
|
(12 |
) |
|
|
- |
|
|
|
(751 |
) |
|
|
- |
|
|
|
(140 |
) |
|
|
5,815 |
|
|
Interest and other expense, net
|
|
|
(1,140 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,140 |
) |
Eton Pharmaceuticals, Inc.
Full Year 2025 GAAP and Non-GAAP Net Income (Loss) Reconciliation
(in thousands)
(Unaudited)
|
Year Ended December 31, 2025
|
|
GAAP
|
|
|
Depreciation and Intangible Amortization
|
|
|
Inventory Step-Up Expense
|
|
|
Stock Based Compensation
|
|
|
Severance Expense
|
|
|
Acquisition/ Divestiture Related Costs
|
|
|
Non-GAAP
|
|
|
Cost of sales
|
|
$ |
37,210 |
|
|
|
(4,003 |
) |
|
|
(5,094 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
28,113 |
|
|
Research and development
|
|
|
7,765 |
|
|
|
- |
|
|
|
- |
|
|
|
(182 |
) |
|
|
- |
|
|
|
- |
|
|
|
7,583 |
|
|
General and administrative
|
|
|
35,819 |
|
|
|
(41 |
) |
|
|
- |
|
|
|
(5,330 |
) |
|
|
(335 |
) |
|
|
(581 |
) |
|
|
29,532 |
|
|
Interest and other expense, net
|
|
|
(3,714 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,714 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
$ |
15,600 |
|
|
|
(1,096 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
14,504 |
|
|
Research and development
|
|
|
3,255 |
|
|
|
- |
|
|
|
- |
|
|
|
(276 |
) |
|
|
- |
|
|
|
- |
|
|
|
2,979 |
|
|
General and administrative
|
|
|
22,753 |
|
|
|
(50 |
) |
|
|
- |
|
|
|
(2,889 |
) |
|
|
- |
|
|
|
(415 |
) |
|
|
19,399 |
|
|
Interest and other expense, net
|
|
|
(1,211 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,211 |
) |
