Eton Pharmaceuticals Reports Third Quarter 2025 Financial Results

Rhea-AI Summary

Eton Pharmaceuticals (Nasdaq: ETON) reported Q3 2025 product sales of $22.5 million, a 129% year-over-year increase and the 19th consecutive quarter of sequential product sales growth. GAAP EPS was $(0.07), non-GAAP EPS was $0.04, and Adjusted EBITDA was $2.9 million. The company had $37.1 million in cash and generated $12.0 million of operating cash flow in the quarter.

Pipeline and commercial updates include an NDA for ET-600 accepted with a PDUFA date of February 25, 2026, GALZIN relaunch ahead of plan, progress toward KHINDIVI label expansion with a planned bioequivalence study, and an ET-700 pilot PET study scheduled to begin in Q1 2026.

Positive

• Product sales +129% YoY to $22.5 million
• 19th straight quarter of sequential product sales growth
• Adjusted EBITDA $2.9M in Q3 2025
• $12.0M generated from operating cash flow in Q3 2025
• ET-600 NDA accepted with PDUFA date Feb 25, 2026
• GALZIN relaunch ahead of plan with accelerating patient uptake

Negative

• GAAP net loss of $1.9M (Q3 2025)
• Adjusted gross margin 45% in Q3 2025 vs 64% prior year
• G&A increased from $5.3M to $8.1M in Q3 2025
• $4.1M of COGS from initial loading order to Esteve impacted margins

Insights

Commercial and Financial Analyst

Strong commercial momentum: double‑digit revenue growth, positive adjusted EBITDA, and cash generation support near‑term execution.

Eton reported Q3 2025 product sales of $22.5 million, a year‑over‑year increase of 129% and the company’s nineteenth consecutive quarter of sequential sales growth. Adjusted EBITDA was $2.9 million and operating cash flow generation in the quarter was $12.0 million, which together point to improving operating leverage as recent acquisitions (INCRELEX, GALZIN) scale.

The key dependencies are the pace of commercial adoption and resolution of one‑time transition costs tied to INCRELEX ex‑US activity which depressed adjusted gross margin this quarter (adjusted gross margin fell to 45% versus prior year). Management expects adjusted gross margin to recover toward ~70% in Q4 and adjusted G&A to remain flat or decline, which are natural near‑term drivers to monitor over the next quarter.

Concrete items to watch in the near term: reported Q4 adjusted gross margin guidance, actual operating cash flow in the next quarter, and the cadence of recurring semi‑finished INCRELEX sales to Esteve that management describes as ongoing. Time horizon: next 3–6 months for Q4 financials and margin guidance, and 6–12 months to assess recurring revenue contribution from acquired brands.

Regulatory and Pipeline Strategist

NDA acceptance and PDUFA date materially de‑risk near‑term commercial launch but label expansion work remains conditional on study outcomes.

The FDA accepted the NDA for ET‑600 and assigned a PDUFA action date of February 25, 2026, and the company is preparing launch inventory and pre‑launch activities aiming for a potential Q1 2026 launch. The firm also reported a successful FDA meeting that identified a bioequivalence pathway to broaden the KHINDIVI label, with a bioequivalence study planned to start by January 2026 and a supplement submission possible in Q2 2026 followed by a roughly ten‑month review.

Risks and dependencies are factual and stated: ET‑600 approval depends on the pending PDUFA decision; KHINDIVI label expansion depends on the planned bioequivalence study and the supplement review timeline. The company also submitted a proposed study to support INCRELEX label expansion and expects FDA feedback in December; initiation of a study could follow in H1 2026 if feedback is favorable.

Concrete milestones to monitor: the February 25, 2026 PDUFA outcome for ET‑600, FDA feedback in December on the INCRELEX study design, start of the KHINDIVI bioequivalence study by January 2026, and ET‑700 pilot study results expected mid‑2026. Time horizon: regulatory readouts and study starts mainly within the next 3–9 months that will determine near‑term label and launch catalysts.

• Q3 2025 product sales of $22.5 million, representing 129% growth over Q3 2024 and 19^th straight quarter of sequential product sales growth
• Q3 2025 basic and fully diluted GAAP EPS of $(0.07), non-GAAP fully diluted EPS of $0.04, and Adjusted EBITDA of $2.9 million
• ET-600 NDA accepted for review, assigned PDUFA date of February 25, 2026
• GALZIN® launch ahead of plan; exceeded previous year-end target of 200 active patients
• Held positive FDA meeting clarifying pathway to KHINDIVI™ label expansion
• Submitted proposed clinical study to support INCRELEX® label expansion
• Generated $12.0 million of cash from operations in the quarter
• Management to hold conference call today at 4:30pm ET
  
  

DEER PARK, Ill., Nov. 06, 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 reported financial results for the quarter ended September 30, 2025.

“The third quarter was another stellar period for Eton with product sales growing 129% year over year. The impressive results came from strong contributions across our diversified portfolio – ALKINDI SPRINKLE and Carglumic Acid produced strong year over year growth, and INCRELEX and GALZIN delivered major revenue contributions. Both of these recently acquired brands have been reinvigorated with our substantial new investments, including meaningful increases in patient support and education. Our activities with INCRELEX and GALZIN have resonated with the community, improving patient experience and broadening awareness. Both products continue to track ahead of our original expectations,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

“In addition to our strong commercial performance, we continued to advance our pipeline programs and received favorable news when our New Drug Application (NDA) for ET-600 was accepted for review by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) date of February 25, 2026. With ET-600, we are excited about the potential to address a significant unmet need within the pediatric endocrinology community, and we have begun full launch preparation activities, eyeing a potential launch in the first quarter of 2026. During the quarter we also held a meeting with the FDA and believe we have reached alignment on a path to broaden the KHINDIVI label,” continued Brynjelsen.

“2025 has been a transformational year for Eton. We look forward to closing it out with strong momentum that can propel us to an even more impressive 2026. In addition to continued growth from key products ALKINDI, INCRELEX, GALZIN, and KHINDIVI, we expect to launch ET-600, progress the label expansion programs for KHINDIVI and INCRELEX, and complete ET-700’s pilot clinical study,” concluded Brynjelsen.

Third Quarter and Recent Business Highlights

19^th straight quarter of sequential growth in product sales and 129% growth over prior year quarter. Eton reported third quarter 2025 product sales of $22.5 million. Year-over-year revenue growth was driven primarily by continued growth in ALKINDI SPRINKLE and Carglumic Acid and the addition of revenues from INCRELEX and GALZIN.

INCRELEX relaunch continues to exceed original expectations. INCRELEX was the largest revenue contributor to Eton’s third quarter results. Since relaunching the product, the Company has made considerable progress raising awareness and expanding access to this critical treatment. Eton continues to see an attractive long-term opportunity to invest in education and awareness surrounding severe primary IGF-1 deficiency (SPIGFD), which the Company and key thought leaders believe to be underdiagnosed and undertreated. Eton is committed to expanding INCRELEX access to patients and is pursuing the harmonization of the U.S. and European Union (EU) definitions of SPIGFD as the EU definition encompasses a significantly larger patient population. The Company has submitted a meeting request to the FDA with a proposed study design to support the expanded definition and expects to receive FDA feedback in December. If favorable, Eton could initiate a study in the first half of 2026. The U.S. patient population could increase from approximately 200 to an estimated 1,000 if the EU definition is adopted in the U.S.

GALZIN relaunch seeing strong adoption and enthusiastic reception from patient and clinician community. After acquiring the product in December 2024, the Company relaunched GALZIN in March 2025. Initial patient uptake has been strong and accelerated in the third quarter as Eton’s rare disease specialists and commercial team further established and strengthened relationships with leading prescribers in the Wilson disease community. The Company recently attended and had a significant presence at the Wilson Disease Association Annual Summit as a top sponsor, where it engaged with patients and industry leaders. Eton’s entry into Wilson disease has been met with enthusiasm from patients, caregivers, and healthcare practitioners, with particular recognition for the Company’s enhanced patient support services and educational efforts.

ET-700 pilot study scheduled to initiate in the first quarter of 2026. The Company is scheduled to begin its proof-of-concept positron emission tomography (PET) study in the first quarter of 2026 and anticipates having results in mid-2026. The study is expected to validate the efficacy of the Company’s propriety, patent-pending extended-release formulation, and if positive, would support the initiation of a dose ranging and pivotal clinical trial in late 2026 or early 2027.

ALKINDI SPRINKLE continues to post strong sequential and year-over-year growth. ALKINDI SPRINKLE delivered strong sequential and year-over-year growth in both revenue and patients on treatment, boosted by strong output from the Company’s sales force that is now entirely dedicated to pediatric endocrinology. Eton and ALKINDI had a presence at key endocrinology events in the third quarter, including ENDO, the Endocrine Society Annual Meeting. In the fourth quarter, the Company will be presenting or participating in the CARES Foundation Annual Conference and Patient Advisory Summit, SCOPE (Southern California Organization of Pediatric Endocrinologists), SPES (Southern Pediatric Endocrinology Society), AAP (American Academy of Pediatrics) and ILACE (Illinois Association of Clinical Endocrinology).

Successful FDA meeting regarding development of revised KHINDIVI formulation. While initial feedback from patients and caretakers has been favorable, the age restriction on KHINDIVI’s label has limited its adoption. The product’s current approved indication is for patients age five and above, but the largest unmet need for precision dosing and liquid dosage is in the infant and toddler population under five years old. In September, Eton met with the FDA to discuss a pathway for the company’s revised KHINDIVI formulation with lower levels of inactive ingredients. The agency indicated an openness to expanding the indicated age and requested the Company conduct a bioequivalence study comparing the two formulations. The bioequivalence study is scheduled to initiate by January 2026, which would allow for the revised formulation to be submitted as a supplement to the existing NDA in the second quarter of 2026. The FDA indicated a 10-month review for the submission, leading to a potential early 2027 approval. The Company expects product adoption to significantly increase if KHINDIVI is approved for younger patients.

NDA for ET-600 accepted for review by the FDA. In July, 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 fourth quarter in preparation for a commercial launch shortly after the anticipated approval. Pre-launch marketing activities are underway. The Company recently held an ET-600 advisory meeting with leading healthcare practitioners within the pediatric endocrinology community, and patients and healthcare providers continue to express excitement for the product.

Third Quarter Financial Results

Net Revenue: Net revenues for the third quarter of 2025 were $22.5 million compared with $10.3 million in the prior year period, an increase of 118%.

Net product revenues for the third quarter of 2025 were $22.5 million compared with $9.8 million in the prior year period, an increase of 129%. The growth was driven primarily by increased sales of ALKINDI SPRINKLE and Carglumic Acid and the addition of sales from INCRELEX and GALZIN.

$0.9 million of product revenue was from the sale of finished product inventory to Ipsen S.A. (“Ipsen”) and Esteve Pharmaceuticals, S.A. (“Esteve”) and transition services to facilitate the ownership transition of INCRELEX in certain European countries and is expected to be non-recurring. $2.4 million of revenue was derived from an initial loading order of semi-finished INCRELEX inventory to Esteve. The Company previously entered into a long-term supply agreement with Esteve and expects such semi-finished good purchases to continue on an annual or semi-annual basis.

Gross Profit: Gross profit for the third quarter of 2025 was $7.9 million compared with $6.3 million in the prior year period, an increase of 25%. Gross profit was negatively impacted by costs related to the transition of the ex-U.S. distribution of INCRELEX. Of total cost of goods sold (COGS) expense in the quarter, $1.4 million was due to sales commissions to Ipsen related to transition services. $1.9 million of COGS expense was finished product inventory sold to Ipsen and Esteve to facilitate the ownership transition. Marketing authorizations have now been transferred in key European countries and the company expects transition related costs to decline significantly in the fourth quarter and cease completely by mid-2026. An additional $4.1 million of COGS expense was from the initial loading order of semi-finished goods to Esteve to support future in-market sales.

Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was $10.2 million in the third quarter of 2025, representing an adjusted gross margin of 45% compared to adjusted gross profit of $6.6 million and adjusted gross margin of 64% in the prior year period. Adjusted gross margin in the quarter was negatively impacted by INCRELEX ex-US related costs. The Company expects to report fourth quarter adjusted gross margin of approximately 70%.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $1.1 million compared to $0.5 million in the prior year period, due primarily to increased expenses associated with the Company’s ET-700 and ET-800 development activities.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $8.1 million compared to $5.3 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 $6.9 million in the quarter, compared with $4.3 million the prior year period. The Company expects Adjusted G&A expenses to remain flat or decline in the fourth quarter of 2025.

Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA): Adjusted EBITDA for the third quarter of 2025 was $2.9 million and was negatively impacted by the INCRELEX ex-US related costs. Adjusted EBITDA was $2.0 million in the prior year period.

Net Income/Loss: Net loss for the third quarter of 2025 was $1.9 million or $0.07 per diluted share compared to net income of $0.6 million or $0.02 per diluted share in the prior year period.

On a non-GAAP basis, the Company reported net income of $1.5 million or $0.04 per diluted share, for the third quarter of 2025 compared to net income of $1.9 million, or $0.07 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 September 30, 2025, the Company had cash and cash equivalents of $37.1 million and generated $12.0 million of operating cash flow during the quarter. During the quarter, Eton received a $4.3 million cash payment for the INCRELEX ex-U.S. licensing agreement executed in the first quarter.

Conference Call and Webcast Information

As previously announced, Eton Pharmaceuticals will host its third quarter 2025 conference call as follows:

Date:	November 6, 2025
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 eight commercial rare disease products: KHINDIVI™, INCRELEX^®, ALKINDI SPRINKLE^®, GALZIN^®, PKU GOLIKE^®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ET-600, 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) (Unaudited)
		For the three months ended						For the nine months ended
		September 30,			September 30,			September 30,			September 30,
		2025			2024			2025			2024
Revenues:
Licensing revenue		$	—		$	500		$	3,286		$	500
Product sales and royalties, net			22,459			9,824			55,383			26,864
Total net revenues			22,459			10,324			58,669			27,364
Cost of sales:
Licensing revenue			—			270			825			270
Product sales and royalties			14,604			3,752			28,204			10,159
Total cost of sales			14,604			4,022			29,029			10,429
Gross profit			7,855			6,302			29,640			16,935
Operating expenses:
Research and development			1,112			505			5,985			4,126
General and administrative			8,106			5,288			26,963			16,035
Total operating expenses			9,218			5,793			32,948			20,161
Loss (income) from operations			(1,363)			509			(3,308)			(3,226)
Other expense:
Interest and other expense, net			(592)			(8)			(2,664)			(71)
(Loss) income before income tax expense			(1,955)			501			(5,972)			(3,297)
Income tax (benefit) expense			(28)			(126)			112			(72)
Net (loss) income		$	(1,927)		$	627		$	(6,084)		$	(3,225)
Net (loss) income per share, basic and diluted		$	(0.07)		$	0.02		$	(0.23)		$	(0.12)
Weighted average number of common shares outstanding, basic and diluted			26,893			25,900			26,891			25,814
Net income (loss) per share, diluted		$	(0.07)		$	0.02		$	(0.23)		$	(0.12)
Weighted average number of common shares outstanding, diluted			26,893			26,550			26,891			25,814

Eton Pharmaceuticals, Inc. Balance Sheets (In thousands, except share and per share amounts)
		September 30, 2025			December 31, 2024
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents		$	37,121		$	14,936
Accounts receivable, net			13,082			5,361
Inventories, net			16,855			15,232
Prepaid expenses and other current assets			4,942			5,492
Total current assets			72,000			41,021
Property and equipment, net			294			34
Intangible assets, net			31,878			34,881
Operating lease right-of-use assets, net			319			175
Other long-term assets, net			19			12
Total assets		$	104,510		$	76,123
Liabilities and stockholders’equity
Current liabilities:
Accounts payable		$	14,259		$	4,167
Short-term debt, net of discount			2,776			—
Accrued Medicaid rebates			18,031			6,866
Accrued liabilities			9,117			8,914
Total current liabilities			44,183			19,947
Long-term debt, net of discount and including accrued fees			27,591			29,811
Operating lease liabilities, net of current portion			480			107
Long-term inventory payable			5,188			—
Other long-term liabilities			3,942			1,830
Total liabilities			81,384			51,695
Commitments and contingencies
Stockholders’equity
Common stock, $0.001 par value; 50,000,000 shares authorized; 26,817,535 and 26,709,084 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively			27			27
Additional paid-in capital			137,076			132,294
Accumulated deficit			(113,977)			(107,893)
Total stockholders’equity			23,126			24,428
Total liabilities and stockholders’equity		$	104,510		$	76,123

Eton Pharmaceuticals, Inc. Statements of Cash Flows (In thousands) (Unaudited)
		Nine months ended			Nine months ended
		September 30, 2025			September 30, 2024
Cash flows from (used in) operating activities
Net loss		$	(6,084)		$	(3,225)
Adjustments to reconcile net loss to net cash from operating activities:
Stock-based compensation			4,388			2,383
Depreciation and amortization			3,027			791
Inventory step-up			3,673			—
Non-cash lease expense			35			53
Debt discount amortization and non-cash interest expenses			521			70
Changes in operating assets and liabilities:
Accounts receivable			(7,721)			(2,179)
Inventories			(5,295)			(1,027)
Prepaid expenses and other assets			550			171
Accounts payable			10,092			836
Accrued Medicaid rebates			11,165			4,420
Accrued liabilities			585			(559)
Other non-current assets and liabilities			7,139			—
Net cash from (used in) operating activities			22,075			1,734
Cash flows from (used in) investing activities
Purchases of product license rights			—			(1,868)
Purchases of property and equipment			(284)			(14)
Net cash from (used in) investing activities			(284)			(1,882)
Cash flows from (used in) financing activities
Repayment of long-term debt			—			(1,155)
Proceeds from stock option exercises			394			176
Net cash from (used in) financing activities			394			(979)
Change in cash and cash equivalents			22,185			(1,127)
Cash and cash equivalents at beginning of period			14,936			21,388
Cash and cash equivalents at end of period		$	37,121		$	20,261
Supplemental disclosures of cash flow information
Cash paid for interest		$	2,395		$	525
Cash paid for income taxes		$	117		$	181

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 nine months ended
		September 30,			September 30,			September 30,			September 30,
		2025			2024			2025			2024
GAAP net income (loss)		$	(1,927)		$	627		$	(6,084)		$	(3,225)
Depreciation (1)			8			12			24			38
Intangible amortization expense (2)			1,001			267			3,003			753
Interest expense (including debt discount amortization and non-cash interest expenses)			1,212			211			3,573			672
Income tax expense (benefit)			(28)			(126)			112			(72)
EBITDA		$	266		$	991		$	628		$	(1,834)
Other non-GAAP adjustments:
Inventory step-up expense (3)			1,324			—			3,673			—
Stock-based compensation (4)			1,092			722			4,388			2,383
Severance expense (5)			—			—			335			—
Acquisition/divestiture-related costs (6)			190			275			574			275
Total of Other non-GAAP adjustments			2,606			997			8,970			2,658
Adjusted EBITDA		$	2,872		$	1,988		$	9,598		$	824
GAAP income (loss) before income tax		$	(1,955)		$	501		$	(5,972)		$	(3,297)
Non-GAAP adjustments:
Depreciation (1)			8			12			24			38
Intangible amortization expense (2)			1,001			267			3,003			753
Inventory step-up expense (3)			1,324			—			3,673			—
Share-based compensation (4)			1,092			722			4,388			2,383
Severance expense (5)			—			—			335			—
Divestiture-related costs (6)			190			275			574			275
Total pre-tax non-GAAP adjustments			3,615			1,276			11,997			3,449
Income tax effect of pre-tax non-GAAP adjustments (7)			177			(118)			607			(45)
Total non-GAAP adjustments			3,438			1,394			11,390			3,494
Non-GAAP Net Income		$	1,483		$	1,895		$	5,418		$	197
Weighted average number of common shares outstanding, basic			26,893			25,900			26,891			25,814
Weighted average number of common shares outstanding, diluted			31,137			26,550			31,014			26,412
GAAP (loss) income per share – Basic		$	(0.07)		$	0.02		$	(0.23)		$	(0.12)
Non-GAAP adjustments			0.13			0.05			0.42			0.14
Non-GAAP earnings per share – Basic		$	0.06		$	0.07		$	0.19		$	0.02
GAAP (loss) income per share – Basic		$	(0.07)		$	0.02		$	(0.23)		$	(0.12)
Non-GAAP adjustments			0.11			0.05			0.37			0.13
Non-GAAP earnings per share – Diluted		$	0.04		$	0.07		$	0.14		$	0.01

(1) Represents depreciation expense related to our property and equipment.
(2) Intangible amortization expenses are associated with our intellectual property rights related to INCRELEX®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous and Nitisinone.
(3) During the three and nine months ended September 30, 2025, we recognized in cost of sales $1,324 and $3,673, respectively, for inventory step-up expense primarily attributable to INCRELEX® inventory revalued in connection with this product acquisition.
(4) 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.
(5) Represents severance and benefit expenses associated with role redundancy within commercial operations during the first quarter of 2025.
(6) 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.
(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 as the Company is in a full income tax valuation allowance position and the income tax adjustments on a pre-tax non-GAAP adjustment is commensurate with the performance measure.

Eton Pharmaceuticals, Inc.
Third Quarter 2025 GAAP to Non-GAAP Net Income (Loss) Reconciliation
(In thousands, except per share amounts)
(Unaudited)
		GAAP			Depreciation and Intangible Amortization			Inventory Step-Up Expense			Stock Based Compensation			Divestiture Related Costs			Non-GAAP
Revenues:
Licensing revenue		$	0		$	—		$	—		$	—		$	—		$	—
Product sales and royalties			22,459			—			—			—			—			22,459
Total net revenues			22,459			—			—			—			—			22,459
Cost of sales:
Licensing revenue			—			—			—			—			—			—
Product sales and royalties			14,604			(1,001)			(1,324)			—			—			12,279
Total cost of sales			14,604			(1,001)			(1,324)			—			—			12,279
Gross profit			7,855			1,001			1,324			—			—			10,180
Operating expenses:
Research and development			1,112			—			—			(38)			—			1,074
General and administrative			8,106			(8)			—			(1,054)			(190)			6,854
Total operating expenses			9,218			(8)			—			(1,092)			(190)			7,928
(Loss) income from operations			(1,363)			1,009			1,324			1,092			190			2,252
Other expense:
Interest and other expense, net			(592)			—			—			—			—			(592)
(Loss) income before income tax expense			(1,955)			1,009			1,324			1,092			190			1,660
Income tax (benefit) expense			(28)			57			75			62			11			177
Net (loss) income		$	(1,927)		$	952		$	1,249		$	1,030		$	179		$	1,483
Net (loss) income per share, basic		$	(0.07)		$	0.03		$	0.05		$	0.04		$	0.01		$	0.06
Net (loss) income per share, diluted		$	(0.07)		$	0.03		$	0.04		$	0.03		$	0.01		$	0.04
Weighted average number of common shares outstanding, basic			26,893
Weighted average number of common shares outstanding, diluted			31,137

Eton Pharmaceuticals, Inc.
YTD 2025 GAAP to Non-GAAP Net Income (Loss) Reconciliation
(In thousands, except per share amounts)
(Unaudited)
		GAAP			Depreciation and Intangible Amortization			Inventory Step-Up Expense			Stock Based Compensation			Severance Expense			Divestiture Related Costs			Non-GAAP
Revenues:
Licensing revenue		$	3,286		$	—		$	—		$	—		$	—		$	—		$	3,286
Product sales and royalties			55,383			—			—			—			—			—			55,383
Total net revenues			58,669			—			—			—			—			—			58,669
Cost of sales:
Licensing revenue			825			—			—			—			—			—			825
Product sales and royalties			28,204			(3,003)			(3,673)			—			—			—			21,528
Total cost of sales			29,029			(3,003)			(3,673)			—			—			—			22,353
Gross profit			29,640			3,003			3,673			—			—			—			36,316
Operating expenses:
Research and development			5,985			—			—			(120)			—			—			5,865
General and administrative			26,963			(24)			—			(4,268)			(335)			(574)			21,762
Total operating expenses			32,948			(24)			—			(4,388)			(335)			(574)			27,627
(Loss) income from operations			(3,308)			3,027			3,673			4,388			335			574			8,689
Other expense:
Interest and other expense, net			(2,664)			—			—			—			—			—			(2,664)
(Loss) income before income tax expense			(5,972)			3,027			3,673			4,388			335			574			6,025
Income tax expense			112			125			152			181			14			24			607
Net (loss) income		$	(6,084)		$	2,902		$	3,521		$	4,207		$	321		$	550		$	5,418
Net (loss) income per share, basic		$	(0.23)		$	0.11		$	0.13		$	0.15		$	0.01		$	0.02		$	0.19
Net (loss) income per share, diluted		$	(0.23)		$	0.09		$	0.11		$	0.14		$	0.01		$	0.02		$	0.14
Weighted average number of common shares outstanding, basic			26,891
Weighted average number of common shares outstanding, diluted			31,014

FAQ

What were ETON's reported product sales and year-over-year growth in Q3 2025?

Eton reported $22.5 million in product sales, a 129% increase versus Q3 2024.

When is the PDUFA date for Eton's ET-600 NDA (ETON)?

The ET-600 NDA was accepted with a PDUFA date of February 25, 2026.

How much cash did ETON have and how much operating cash flow did it generate in Q3 2025?

As of September 30, 2025, Eton had $37.1 million in cash and generated $12.0 million of operating cash flow in the quarter.

What were ETON's GAAP and non-GAAP EPS for Q3 2025?

GAAP EPS was $(0.07) and non-GAAP fully diluted EPS was $0.04 for Q3 2025.

What progress did ETON report on KHINDIVI label expansion (ETON)?

Eton met with the FDA and plans a bioequivalence study starting by January 2026, with a supplemental NDA submission targeted in Q2 2026 and an estimated 10-month review.

What commercial products drove ETON's Q3 2025 revenue growth?

Revenue growth was primarily driven by increased sales of ALKINDI SPRINKLE, Carglumic Acid, and the addition of INCRELEX and GALZIN.

When will ETON initiate the ET-700 pilot study and when are results expected?

The ET-700 proof-of-concept PET pilot study is scheduled to initiate in Q1 2026 with results anticipated in mid-2026.