Eton Pharmaceuticals Reports Third Quarter 2026 Financial Results

The raised outlook calls for an adjusted EBITDA margin of at least 40%, up from at least 35% previously.

Rhea-AI Summary

Eton Pharmaceuticals (ETON) reported third-quarter 2026 revenue of $57.9 million, up 158% from the prior-year quarter, and raised its annual outlook. Eton now expects 2026 revenue above $175 million, versus above $145 million previously, and an adjusted EBITDA margin of at least 40%, versus at least 35%. Adjusted EBITDA, an earnings measure excluding specified expenses, reached $28.5 million, or 49% of revenue, versus $2.9 million and 13% a year earlier.

GAAP net income was $35.2 million, or $1.06 per diluted share, versus a $1.9 million loss. Earnings included a one-time tax benefit; non-GAAP diluted earnings were $0.50 per share. Cash was $55.6 million at September 30. Eton licensed LIBERVANT, targeting an April 2027 launch subject to FDA approval, and advanced several development programs. ET-700's pilot study showed fewer treatment-related adverse events but less reduction in hepatic copper uptake than GALZIN.

32 points · 1 major

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0 major · 10 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major point. Forward-looking: it has not happened yet and may not happen.2026 revenue guidance increased to more than $175 million from more than $145 million.
• Moderate pointQ3 revenue rose 158% year over year to $57.9 million from $22.5 million.
• Moderate pointQ3 adjusted EBITDA reached $28.5 million, versus $2.9 million; margin rose to 49% from 13% year over year.
• Moderate pointQ3 GAAP net income reached $35.2 million, or $1.06 diluted, versus a $1.9 million loss, or $0.07 diluted.
• Moderate pointQ3 non-GAAP net income rose to $16.5 million, or $0.50 diluted, from $1.5 million, or $0.04 diluted.
• Moderate pointQ3 gross profit increased 464% year over year to $44.3 million from $7.9 million.
• Moderate pointQ3 adjusted gross profit reached $46.2 million, versus $10.2 million; margin increased to 80% from 45% year over year.
• Moderate point$200 million annualized revenue run rate goal was surpassed five quarters ahead of schedule.
• Moderate point. Forward-looking: it has not happened yet and may not happen.LIBERVANT exclusive license and supply agreement signed; Eton anticipates an April 2027 launch.

23 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.2026 adjusted EBITDA margin guidance rose to at least 40% from at least 35%.
• Minor pointQ3 adjusted EBITDA margin increased to 49% from 43% in the second quarter of 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.Full-year 2026 adjusted gross margin is expected to exceed 70%.
• Minor pointQ3 operating income reached $23.013 million, versus a $1.363 million loss in the prior-year quarter.
• Minor pointQ3 EBITDA increased to $24.8 million from $0.3 million in the prior-year quarter.
• Minor pointCash increased to $55.628 million at September 30, 2026, from $25.942 million at December 31, 2025.
• Minor pointNine-month revenue reached $119.780 million, versus $58.669 million in the corresponding 2025 period.
• Minor pointNine-month gross profit reached $84.449 million, versus $29.640 million in the corresponding 2025 period.
• Minor pointNine-month operating income reached $38.221 million, versus a $3.308 million loss in the corresponding 2025 period.
• Minor pointNine-month net income reached $48.381 million, or $1.48 diluted, versus a $6.084 million loss, or $0.23 diluted.
• Minor pointActive patient counts reached records for INCRELEX, HEMANGEOL, ALKINDI SPRINKLE, KHINDIVI, DESMODA and GALZIN.
• Minor point. Forward-looking: it has not happened yet and may not happen.Organic growth across those products is expected by Eton through the remainder of 2026 and beyond.
• Minor pointET-900 patent rights licensed from Baylor; a Phase 2 research application was submitted to the FDA.
• Minor point. Forward-looking: it has not happened yet and may not happen.ET-900 Phase 2 enrollment and dosing are anticipated to begin in the first quarter of 2027.
• Minor pointET-700 treatment-related adverse events occurred in 1 of 12 participants, versus 8 of 12 with GALZIN.
• Minor point. Forward-looking: it has not happened yet and may not happen.ET-700 additional study arms are planned for 2027 to evaluate faster-release formulations.
• Minor pointKHINDIVI label expansion accepted for FDA review, with a May 28, 2027 decision date.
• Minor point. Forward-looking: it has not happened yet and may not happen.ASN-001 U.S. rights acquired; Eton anticipates a 2027 New Drug Application submission.
• Minor point. Forward-looking: it has not happened yet and may not happen.ASN-001 bioavailability study initiated, with the first participant expected to be dosed in January 2027.
• Minor pointIMPAVIDO launched in September with Eton as exclusive U.S. distributor.
• Minor point. Forward-looking: it has not happened yet and may not happen.INCRELEX label expansion study initiated; Eton anticipates dosing the first patients in the coming months.
• Minor pointGlyburide Oral Suspension bioavailability study completed; the candidate also received FDA Fast Track designation.
• Minor point. Forward-looking: it has not happened yet and may not happen.Glyburide application submission remains on track for late 2026 or early 2027, with potential approval and launch in 2027.

Negative

• Moderate pointQ3 general and administrative expense increased 98% year over year to $16.0 million from $8.1 million.
• Minor pointQ3 research and development expense rose to $5.3 million from $1.1 million, including $3 million for ASN-001 rights.
• Minor pointQ3 adjusted general and administrative expense rose to $12.8 million from $6.9 million a year earlier.
• Minor pointNine-month research and development expense rose to $8.139 million from $5.985 million in the corresponding 2025 period.
• Minor pointNine-month general and administrative expense rose to $38.089 million from $26.963 million in the corresponding 2025 period.

5 minor points

• Minor pointQ3 interest and other expense increased to $656,000 from $592,000 in the prior-year quarter.
• Minor pointET-700 hepatic copper uptake decreased 12%, versus a 46% decrease with GALZIN and an 11% increase with placebo.
• Minor point. Forward-looking: it has not happened yet and may not happen.KHINDIVI expansion to children under five remains pending; commercial launch is anticipated shortly after approval, if granted.
• Minor pointLIBERVANT FDA review remains pending for ages 6–11, with a March 29, 2027 decision date.
• Minor point. Forward-looking: it has not happened yet and may not happen.INCRELEX population expansion depends on study success; Eton estimates potential growth from 200 to 1,000 eligible U.S. patients.

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Key Figures

Q3 revenue: $57.9 million Revenue growth: 158% 2026 revenue guidance: More than $175 million +5 more

Q3 revenue

$57.9 million

Third quarter 2026

Revenue growth

158%

Year over year, Q3 2026

2026 revenue guidance

More than $175 million

Raised from prior guidance of more than $145 million

Adjusted EBITDA

$28.5 million

Third quarter 2026

Adjusted EBITDA margin

49%

Third quarter 2026

2026 Adjusted EBITDA margin guidance

At least 40%

Raised from prior guidance of at least 35%

GAAP diluted EPS

$1.06

Third quarter 2026

Non-GAAP diluted EPS

$0.50

Third quarter 2026

Previous Earnings Reports

1 past event · Latest: Aug 13

Same Type 1 event

1. Aug 13

   Q2 earnings

   24h Move

   +44.3%

   Q2 revenue reached $37.6 million; guidance rose to over $145 million and 35% margin.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

ebitda, gaap, non-gaap, investigational new drug (ind), +2 more

6 terms

ebitda financial

"Adjusted EBITDA for the third quarter of 2026 was $28.5 million"

EBITDA stands for earnings before interest, taxes, depreciation, and amortization. It measures a company's profitability by focusing on the money it makes from its core operations, ignoring expenses like taxes and accounting adjustments. Investors use EBITDA to compare how well different companies are performing financially, as it provides a clearer picture of operational success without the influence of financial structure or accounting choices.

View in glossary

gaap financial

"fully diluted GAAP EPS of $1.06"

GAAP, or Generally Accepted Accounting Principles, are a set of standardized rules and guidelines that companies follow when preparing their financial statements. They ensure consistency, transparency, and comparability across different companies, making it easier for investors to understand and compare financial information accurately. This helps investors make informed decisions based on trustworthy and uniform financial reports.

View in glossary

non-gaap financial

"non-GAAP fully diluted EPS of $0.50"

Non-GAAP refers to financial measures that companies use to show their earnings or performance without including certain expenses or income that are often added back to give a different picture. It matters because it can make a company's results look better or more favorable, but it may also hide important costs, so investors need to look at both GAAP (official rules) and non-GAAP numbers to get a full understanding.

View in glossary

investigational new drug (ind) regulatory

"A research Investigational New Drug (IND) application has been submitted to the FDA"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

positron emission tomography (pet) medical

"proof-of-concept positron emission tomography (PET) study"

Positron emission tomography (PET) is a medical imaging method that uses tiny amounts of radioactive tracer to create detailed pictures of biological activity inside the body, like a camera that highlights where cells are most active. For investors, PET matters because it helps diagnose disease, track how well drugs or treatments are working, and drives demand for scanners, tracer production and clinical trial services—factors that can affect company revenues and regulatory outcomes.

pdufa regulatory

"assigned May 28, 2027 PDUFA date"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Record Q3 2026 product sales of $57.9 million, 158% year-over-year growth; surpassed $200 million annualized revenue run rate goal five quarters ahead of schedule
• Q3 2026 fully diluted GAAP EPS of $1.06, non-GAAP fully diluted EPS of $0.50; EBITDA of $24.8 million, Adjusted EBITDA of $28.5 million or 49% of revenue
• Raised 2026 revenue guidance to more than $175 million, up from prior guidance of more than $145 million; raised 2026 Adjusted EBITDA to more than 40%, up from prior guidance of more than 35%
• Management to hold conference call today at 4:30pm ET

DEER PARK, Ill., Nov. 05, 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 September 30, 2026.

“Eton delivered another record quarter, with revenue of $57.9 million, up 158% year over year, and surpassed our $200 million annualized revenue run rate goal five quarters ahead of schedule. The team also demonstrated exceptional operational execution, significantly expanding margins, and delivering an adjusted EBITDA margin of 49%. We are raising both our revenue and adjusted EBITDA guidance for 2026, reflecting the strong momentum in our business,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

“Growth remained strong across the portfolio, with record levels of active patients for all of our key products, including HEMANGEOL^®, INCRELEX^®, ALKINDI SPRINKLE^®, KHINDIVI^®, GALZIN^® and DESMODA™. Our recent licensing agreement for LIBERVANT^® adds another potential major 2027 launch and will expand us into neurology, giving us an additional therapeutic platform to build on with future transactions.”

“We have also made transformational improvements to our pipeline in recent months with ASN-001 for infantile hemangiomas, and ET-900, our new program evaluating mecasermin in infantile and epileptic spasms. Across our existing development programs, we achieved critical milestones in Q3: FDA acceptance of the KHINDIVI label expansion submission, completion of the Glyburide Oral Suspension bioavailability study, initiation of the INCRELEX label harmonization study, and completion of our ET-700 proof-of-concept study providing clear direction for final product formulation. We believe our pipeline has never been stronger and is positioned to drive continued near- and long-term growth for the Company,” concluded Brynjelsen.

Third Quarter and Recent Business Highlights

Record revenues with 158% growth year-over-year and significant margin expansion. Eton reported third quarter 2026 revenue of $57.9 million, compared to $22.5 million in the prior year period, driven by the addition of sales from HEMANGEOL and higher product sales for INCRELEX, ALKINDI SPRINKLE, KHINDIVI, GALZIN, DESMODA and Carglumic Acid. Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) margin was 49% for the quarter, compared to 13% in the prior-year quarter, and 43% in the second quarter of 2026.

Continued volume growth and record active patient counts across all key products. During the quarter, the Company recorded all-time high active patient counts for key promoted products INCRELEX, HEMANGEOL, ALKINDI SPRINKLE, KHINDIVI, DESMODA, and GALZIN. The Company expects continued organic growth from these products through the remainder of 2026 and beyond.

Initiated ET-900 program in infantile and epileptic spasms. Eton licensed patent rights from Baylor College of Medicine covering the use of insulin-like growth factor 1 (IGF-1) for infantile and epileptic spasms. A research Investigational New Drug (IND) application has been submitted to the FDA for a Phase 2 study evaluating INCRELEX in epileptic spasms. The trial is anticipated to begin enrolling and dosing patients in the first quarter of 2027.

Announced results from ET-700 pilot clinical study. In the proof-of-concept positron emission tomography (PET) study, ET-700 demonstrated an adverse event rate substantially lower than GALZIN. Treatment-related adverse events occurred in 1 of 12 ET-700 participants compared with 8 of 12 GALZIN participants. Hepatic copper uptake decreased 12% with ET-700, compared with a 46% decrease with GALZIN, and an 11% increase with placebo. The Company plans additional study arms in 2027 evaluating faster-release formulations to seek to improve copper absorption inhibition while preserving a favorable safety profile.

KHINDIVI label expansion Prior Approval Supplement (PAS) accepted for review and assigned May 28, 2027 PDUFA date. The PAS submission seeks to expand the indicated age range to include children under five, which the Company believes represents a large unmet need and could accelerate product adoption. If approved, Eton anticipates commercial launch shortly after approval.

Licensed product candidate ASN-001 and initiated bioavailability study, with first participant expected to be dosed in January 2027. In August, Eton acquired the U.S. rights to ASN-001, complementing HEMANGEOL and expanding its infantile hemangioma franchise. The Company believes ASN-001 has the potential to become the Company’s largest revenue-generating product, if approved. With a bioavailability study underway, Eton anticipates submitting a New Drug Application (NDA) in 2027.

Entered into an exclusive license and supply agreement for LIBERVANT, expanding Eton’s reach into neurology. LIBERVANT’s buccal film technology, if approved by the FDA, would offer patients and caregivers an alternative to existing nasal and rectal seizure rescue treatments. The current market is estimated to be more than $450 million in annual sales in the United States. The product has received Orphan Drug Designation and tentative approval for patients ages 2 to 5 and ages 12 years and older. An NDA with a March 29, 2027, PDUFA date is currently under FDA review and if approved, would add ages 6 to 11 to the product’s label. Eton anticipates launching the product in April 2027.

Launched IMPAVIDO^® in the United States in September with expanded patient and hospital access support. Eton is now the exclusive distributor in the United States and has made Eton Cares^® patient support available to all patients. In October, the Company exhibited at IDWeek, the Infectious Disease Society’s annual meeting.

Initiated INCRELEX label expansion study to support the harmonization of the U.S. and E.U. definitions of severe primary IGF-1 deficiency (SPIGFD). If successful, this label expansion could increase the addressable U.S. population from an estimated 200 to 1,000 patients. The Company anticipates dosing the first patients in the coming months.

Completed bioavailability study for pediatric endocrinology development product candidate Glyburide Oral Suspension. The Company is on track to submit an NDA near the end of 2026 or early 2027, allowing for potential approval and launch in 2027. Glyburide Oral Suspension was granted Fast Track designation by the FDA.

Financial Guidance

The Company now expects 2026 revenue of more than $175 million, an increase from its previous guidance of more than $145 million. The Company also expects at least a 40% Adjusted EBITDA margin for 2026, up from its previous guidance of at least 35%.

Third Quarter Financial Results

Net Revenue: Total net revenue for the third quarter of 2026 was $57.9 million compared to $22.5 million in the prior-year period, an increase of 158%, driven by the addition of revenue from HEMANGEOL, as well as year-over-year growth across the portfolio, in particular from INCRELEX, ALKINDI SPRINKLE, GALZIN, KHINDIVI, DESMODA, and Carglumic Acid. Third quarter 2026 revenue included $1.2 million of revenue from INCRELEX and GALZIN sales outside the United States.

Gross Profit: Gross profit for the third quarter of 2026 was $44.3 million compared with $7.9 million in the prior-year period, an increase of 464%, primarily due to increased product sales and a favorable change in product mix.

Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was $46.2 million in the third quarter of 2026, representing an adjusted gross margin of 80%, compared to adjusted gross profit of $10.2 million and adjusted gross margin of 45% in the prior year period. The Company expects full-year 2026 adjusted gross margin to exceed 70%.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2026 were $5.3 million compared to $1.1 million in the prior-year period. The increase was primarily due to the $3 million payment for the rights to ASN-001 and higher R&D spending for the development of Glyburide Oral Suspension.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2026 were $16.0 million compared to $8.1 million in the prior-year period, an increase of 98%, due primarily to higher stock-based compensation expense, increased compensation and benefits costs reflecting additional headcount and business performance, higher operating costs to support a larger business and an expanded portfolio of commercial products, and higher FDA fees following the loss of eligibility for the orphan drug fee exemption.

Adjusted G&A expense, which excludes stock-based compensation, depreciation, transaction-related costs, and other one-time expenses, was $12.8 million in the quarter, compared with $6.9 million in the prior-year period.

Earnings Before Interest, Taxes, Depreciation and Amortization: EBITDA for the third quarter of 2026 was $24.8 million compared to $0.3 million in the prior year period.

Adjusted EBITDA for the third quarter of 2026 was $28.5 million or 49% of revenue, compared to $2.9 million, or 13% of revenue in the prior-year period.

Net Income/Loss: Net income for the third quarter of 2026 was $35.2 million or $1.06 per diluted share compared to a net loss of $1.9 million or $0.07 per diluted share in the prior-year period. During the third quarter of 2026, the Company released the valuation allowance associated with its federal, and a portion of its state, deferred tax assets, resulting in the recognition of an income tax benefit for the period.

On a non-GAAP basis, the Company reported net income of $16.5 million or $0.50 per diluted share for the third quarter of 2026 compared to net income of $1.5 million, or $0.04 per diluted share in the prior-year period. The one-time income tax benefit described above was removed for purposes of non-GAAP net income.

For a reconciliation of GAAP net income/(loss) to “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, 2026, the Company had cash and cash equivalents of $55.6 million.

Conference Call and Webcast Information

As previously announced, Eton Pharmaceuticals will host its third quarter 2026 conference call as follows:

Date:	November 5, 2026
Time:	4:30 p.m. ET (3:30 p.m. CT)
Participant Call Link*:	Click Here
Webcast:	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 twelve rare disease products: KHINDIVI ^®, INCRELEX^®, ALKINDI SPRINKLE^®, DESMODA™, GALZIN^®, HEMANGEOL^®, PKU GOLIKE^®, IMPAVIDO^®, LIBERVANT^®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has six additional product candidates in late-stage development: ASN-001, AMGLIDIA^®, ET-700, ET-800, ET-900, 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 anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “seek” or similar language, or the negative of these words and phrases, 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 EBITDA, Adjusted EBITDA and adjusted EBITDA margin, which are unaudited financial measures that are not calculated in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. EBITDA, Adjusted EBITDA and Adjusted EBITDA margin are considered “non-GAAP” financial measures within the meaning of Regulation G promulgated by the SEC. Management believes that these non-GAAP financial measures reflect 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 EBITDA, Adjusted EBITDA and Adjusted EBITDA margin 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, EBITDA, Adjusted EBITDA and Adjusted EBITDA margin, 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 income/(loss), excluding the effects of stock-based compensation and expenses, interest, taxes, depreciation, amortization, 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 income/(loss). Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net income/(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. Condensed Statements of Operations (In thousands, except per share amounts) (Unaudited)
	For the three months ended								For the nine months ended
	September 30, 2026				September 30, 2025				September 30, 2026				September 30, 2025
Revenues:
Product sales, net	$	57,925			$	22,459			$	119,780			$	55,383
Licensing revenue		—				—				—				3,286
Total net revenues		57,925				22,459				119,780				58,669
Cost of sales:
Product sales and royalties, net		13,624				14,604				35,331				28,204
Licensing revenue		—				—				—				825
Total cost of sales		13,624				14,604				35,331				29,029
Gross profit		44,301				7,855				84,449				29,640
Operating expenses:
Research and development		5,271				1,112				8,139				5,985
General and administrative		16,017				8,106				38,089				26,963
Total operating expenses		21,288				9,218				46,228				32,948
Income (loss) from operations		23,013				(1,363	)			38,221				(3,308	)
Other expense:
Interest and other expense, net		(656	)			(592	)			(2,572	)			(2,664	)
Income (loss) before income tax (benefit) expense		22,357				(1,955	)			35,649				(5,972	)
Income tax (benefit) expense		(12,892	)			(28	)			(12,732	)			112
Net income (loss)	$	35,249			$	(1,927	)		$	48,381			$	(6,084	)
Net income (loss) per share, basic	$	1.23			$	(0.07	)		$	1.74			$	(0.23	)
Weighted average number of common shares outstanding, basic		28,661				26,893				27,855				26,891
Net income (loss) per share, diluted	$	1.06			$	(0.07	)		$	1.48			$	(0.23	)
Weighted average number of common shares outstanding, diluted		33,264				26,893				32,740				26,891

Eton Pharmaceuticals, Inc. Condensed Balance Sheets (In thousands, except share and per share amounts)
	September 30, 2026				December 31, 2025
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	55,628			$	25,942
Accounts receivable, net		26,426				11,757
Inventories, net		11,082				15,419
Prepaid expenses and other current assets		3,646				7,463
Total current assets		96,782				60,581
Property and equipment, net		338				326
Intangible assets, net		44,280				30,878
Operating lease right-of-use assets, net		1,064				310
Deferred tax asset		14,745				—
Other long-term assets, net		64				19
Total assets	$	157,273			$	92,114
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	16,499			$	10,976
Short-term debt, net of debt discount		11,842				8,789
Accrued Medicaid rebates		9,653				9,317
Accrued liabilities		16,101				9,408
Total current liabilities		54,095				38,490
Long-term debt, net of current portion, debt discount and accrued exit fees		11,227				21,769
Operating lease liabilities, net of current portion		1,017				460
Other long-term liabilities		4,011				5,241
Total liabilities		70,350				65,960
Stockholders’ equity
Common stock, $0.001 par value; 50,000,000 shares authorized; 28,827,905 and 27,047,061 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively		29				27
Additional paid-in capital		151,007				138,621
Accumulated deficit		(64,113	)			(112,494	)
Total stockholders’ equity		86,923				26,154
Total liabilities and stockholders’ equity	$	157,273			$	92,114

Eton Pharmaceuticals, Inc. Condensed Statements of Cash Flows (In thousands) (Unaudited)
	For the nine months ended
	September 30, 2026				September 30, 2025
Operating Activities
Net income (loss)	$	48,381			$	(6,084	)
Adjustments to reconcile net income (loss) to net cash from operating activities:
Stock-based compensation		6,295				4,388
Depreciation and amortization		3,961				3,027
Inventory step-up		1,470				3,673
Excess and obsolete inventory reserve		620				337
Debt discount amortization and non-cash interest expenses		488				521
Non-cash lease expense		96				35
Acquired in-process research and development		3,000				—
Reversal of deferred tax asset valuation allowance		(12,892	)			—
Changes in operating assets and liabilities:
Accounts receivable		(14,734	)			(7,721	)
Inventories		3,377				(5,632	)
Prepaid expenses and other assets		3,817				550
Accounts payable		5,523				10,092
Accrued Medicaid rebates		336				11,165
Accrued liabilities		5,460				585
Other non-current assets and liabilities		(5,297	)			7,139
Net cash from operating activities		49,901				22,075
Investing Activities
Purchases of product license rights		(18,225	)			—
Purchases of property and equipment		(83	)			(284	)
Net cash used in investing activities		(18,308	)			(284	)
Financing Activities
Proceeds from stock option exercises		5,823				394
Proceeds from ESPP shares issued		270				—
Repayment of long-term debt		(8,000	)			—
Net cash (used in) from financing activities		(1,907	)			394
Change in cash and cash equivalents		29,686				22,185
Cash and cash equivalents at beginning of period		25,942				14,936
Cash and cash equivalents at end of period	$	55,628			$	37,121
Supplemental disclosures of cash flow information
Cash paid for interest	$	2,401			$	2,395
Cash paid for income taxes, net	$	106			$	117

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, 2026				September 30, 2025				September 30, 2026				September 30, 2025
GAAP Net income (loss)	$	35,249			$	(1,927	)		$	48,381			$	(6,084	)
Depreciation (1)		21				8				65				24
Intangible amortization expense (2)		1,423				1,001				3,896				3,003
Interest expense (including debt discount amortization and non-cash interest expenses)		959				1,212				3,107				3,573
Income tax (benefit) expense		(12,892	)			(28	)			(12,732	)			112
EBITDA	$	24,760			$	266			$	42,717			$	628
Other non-GAAP adjustments:
Inventory step-up expense (3)		470				1,324				1,470				3,673
Stock-based compensation (4)		3,309				1,092				6,295				4,388
Severance expense (5)		—				—				—				335
Acquisition/divestiture-related costs (6)		—				190				—				574
Total of Other non-GAAP adjustments		3,779				2,606				7,765				8,970
Adjusted EBITDA	$	28,539			$	2,872			$	50,482			$	9,598
GAAP Net income (loss)	$	35,249			$	(1,927	)		$	48,381			$	(6,084	)
Non-GAAP adjustments:
Depreciation (1)		21				8				65				24
Intangible amortization expense (2)		1,423				1,001				3,896				3,003
Inventory step-up expense (3)		470				1,324				1,470				3,673
Stock-based compensation (4)		3,309				1,092				6,295				4,388
Severance expense (5)		—				—				—				335
Acquisition/divestiture-related costs (6)		—				190				—				574
Release of deferred tax asset valuation allowance (7)		(12,892	)			—				(12,892	)			—
Total non-GAAP adjustments		(7,669	)			3,615				(1,166	)			11,997
Income tax effect of non-GAAP adjustments (8)		11,074				205				11,880				495
Total non-GAAP adjustments		(18,743	)			3,410				(13,046	)			11,502
Non-GAAP Net income	$	16,506			$	1,483			$	35,335			$	5,418
Weighted average number of common shares outstanding, basic		28,661				26,893				27,855				26,891
Weighted average number of common shares outstanding, diluted		33,264				31,137				32,740				31,014
GAAP income (loss) per share - Basic	$	1.23			$	(0.07	)		$	1.74			$	(0.23	)
Non-GAAP adjustments		(0.65	)			0.13				(0.47	)			0.43
Non-GAAP earnings per share - Basic	$	0.58			$	0.06			$	1.27			$	0.20
GAAP income (loss) per share - Diluted	$	1.06				(0.07	)		$	1.48			$	(0.23	)
Non-GAAP adjustments		(0.56	)			0.11				(0.40	)			0.37
Non-GAAP earnings per share - Diluted	$	0.50			$	0.04			$	1.08			$	0.14

(1)	Represents depreciation expense related to our property and equipment.
(2)	Intangible amortization expenses are associated with the Company's intellectual property rights related to INCRELEX®, HEMANGEOL®, GALZIN®, PKU GOLIKE®, IMPAVIDO®, Carglumic Acid, Betaine Anhydrous and Nitisinone.
(3)	During the three and nine months ended September 30, 2026, the Company recognized in cost of sales $470 and $1,470, respectively, compared to $1,324 and $3,673 during the three and nine ended September 30, 2025, respectively, for inventory step-up expense primarily attributable to the HEMANGEOL® inventory revalued in connection with the product acquisition in 2026 period, and the INCRELEX® inventory revalued in connection with this product acquisition in the 2025 periods.
(4)	Represents stock-based compensation expense associated with the Company's stock option, restricted stock unit and performance stock unit grants to employees and non-employee directors and the Company's 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)	Represents the amount of income tax benefit related to the reversal of previously recorded valuation allowances on our federal and state deferred tax assets.
(8)	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.

Eton Pharmaceuticals, Inc. Third Quarter 2026 GAAP to Non-GAAP Net Income (Loss) Reconciliation (in thousands) (Unaudited)
Third Quarter 2026	GAAP			Depreciation and Intangible Amortization			Inventory Step-Up Expense			Stock-Based Compensation			Severance Expense			Acquisition/ Divestiture Related Costs			Non-GAAP
Cost of sales	$	13,624		(1,423	)		(470	)		—			—			—			$	11,731
Research and development		5,271		—			—			(75	)		—			—				5,196
General and administrative		16,017		(21	)		—			(3,234	)		—			—				12,762
Third Quarter 2025
Cost of sales	$	14,604		(1,001	)		(1,324	)		—			—			—			$	12,279
Research and development		1,112		—			—			(38	)		—			—				1,074
General and administrative		8,106		(8	)		—			(1,054	)		—			(190	)			6,854
Third Quarter YTD 2026	GAAP			Depreciation and Intangible Amortization			Inventory Step-Up Expense			Stock-Based Compensation			Severance Expense			Acquisition/ Divestiture Related Costs			Non-GAAP
Cost of sales	$	35,331		(3,896	)		(1,470	)		—			—			—			$	29,965
Research and development		8,139		—			—			(174	)		—			—				7,965
General and administrative		38,089		(65	)		—			(6,121	)		—			—				31,903
Third Quarter YTD 2025
Cost of sales	$	29,029		(3,003	)		(3,673	)		—			—			—			$	22,353
Research and development		5,985		—			—			(120	)		—			—				5,865
General and administrative		26,963		(24	)		—			(4,268	)		(335	)		(574	)			21,762

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Eton Pharmaceuticals' third-quarter 2026 revenue and earnings?

Eton reported $57.9 million in revenue and GAAP diluted earnings of $1.06 per share for the third quarter of 2026. Revenue increased 158% year over year. GAAP net income was $35.2 million and included a one-time tax benefit; non-GAAP net income was $16.5 million, or $0.50 per diluted share.

What is Eton Pharmaceuticals' updated 2026 financial guidance?

Eton expects more than $175 million in 2026 revenue and an adjusted EBITDA margin of at least 40%. The previous outlook called for revenue above $145 million and an adjusted EBITDA margin of at least 35%. The company also expects full-year adjusted gross margin to exceed 70%.

Why did Eton Pharmaceuticals recognize a tax benefit in the third quarter of 2026?

Eton released the valuation allowance associated with its federal deferred tax assets and a portion of its state deferred tax assets, resulting in an income tax benefit. The one-time benefit was excluded from non-GAAP net income.

What caused Eton Pharmaceuticals' higher administrative expenses in the third quarter of 2026?

Higher stock-based compensation, compensation and benefits costs, operating costs and FDA fees drove the increase. Compensation costs reflected additional headcount and business performance, while operating costs supported a larger business and commercial portfolio. FDA fees increased following the loss of eligibility for the orphan drug fee exemption.