ETON

EX-99.1

2 eton-2026q332026xexx991.htm

EX-99.1

Document

Exhibit 99.1

Eton Pharmaceuticals Reports Third Quarter 2026 Financial Results

•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, from prior guidance of more than $145 million; raised 2026 Adjusted EBITDA to more than 40%, from prior guidance of more than 35%

•Management to hold conference call today at 4:30pm ET

DEER PARK, Ill., November 5, 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 DESMODATM. 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 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

eton20260608_8k.htm

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2026-08-13 2026-08-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

August 13, 2026

Date of Report (Date of earliest event reported)

ETON PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38738

37-1858472

(State

(Commission

(I.R.S. Employer

of incorporation)

File Number)

Identification Number)

21925 W. Field Parkway, Suite 235

Deer Park, Illinois 60010-7278

(Address of principal executive offices) (Zip code)

(847) 787-7361

(Registrant’s telephone number, including area code)

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:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

ETON

NASDAQ Global Market

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).

Emerging growth company ☐

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 13, 2026, Eton Pharmaceuticals, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this 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.

Discussion of Non-GAAP Financial Measures

In the Press Release, we present certain financial information, specifically Adjusted EBITDA, which is not in accordance with generally accepted accounting principles (“U.S. GAAP”). We present Adjusted EBITDA in the Press Release because this metric assists us in comparing our performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance. Our management uses Adjusted EBITA:

● for planning purposes, including the preparation of our annual operating budget and developing and refining our internal projections for future periods;

● to evaluate the effectiveness of our business strategies and as a supplemental tool in evaluating our performance against our budget for each period;

● in communication with our board of directors and investors concerning our financial performance;

● to evaluate prior acquisitions in relation to the existing business; and

● to evaluate comparative net sales performance in prior and future periods.

We believe that the disclosure of Adjusted EBITDA offers an additional financial metric which, when coupled with U.S. GAAP results and the reconciliation to U.S. GAAP results, provides a more complete understanding of our results of operations and the factors and trends affecting our business for securities analysts, investors and other interested parties in the evaluation of our company. We believe Adjusted EBITDA is useful to investors for the following reasons:

● Adjusted EBITDA and similar non-GAAP measures are widely used by investors to measure a company’s operating performance without regard to items that can vary substantially from company to company depending upon financing and accounting methods, book values of assets, tax jurisdictions, capital structures and the methods by which assets were acquired; and

● by comparing our Adjusted EBITDA in different historical periods, our investors can evaluate our operating performance excluding the impact of certain items.

Item 9.01 Financial Statements and Exhibits

Exhibit 99.1

Press Release issued by Eton Pharmaceuticals, Inc. on August 13, 2026 relating to financial results

104

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