Eton Raises 2026 Revenue Guidance After Record Quarter

The Tip Desk · November 11, 2026 · 4 min read

Third-quarter product sales reached $57.9 million, 158% above a year earlier, and the company now expects 2026 revenue of more than $175 million.

Eton Pharmaceuticals (ETON), an innovative pharmaceutical company focused on rare diseases, reported third-quarter 2026 product sales of $57.9 million, up 158% from $22.5 million a year earlier, and said it had surpassed a $200 million annualized revenue run-rate goal five quarters ahead of schedule.

Year-over-year growth accelerated from 99% in the second quarter and 73% in the first quarter. Sequential product sales rose from $37.6 million in the second quarter. The company attributed the increase to the addition of HEMANGEOL sales after its May relaunch and higher product sales across INCRELEX, ALKINDI SPRINKLE, KHINDIVI, GALZIN, DESMODA and Carglumic Acid. Third-quarter revenue included $1.2 million from INCRELEX and GALZIN sales outside the United States.

Adjusted EBITDA was $28.5 million, or 49% of revenue, compared with $2.9 million, or 13%, in the year-ago quarter. Adjusted EBITDA margin had been 43% in the second quarter. GAAP EBITDA was $24.8 million.

Gross profit was $44.3 million. Adjusted gross profit, which excludes acquired inventory step-up and intangible amortization, was $46.2 million, an adjusted gross margin of 80%, compared with $10.2 million and 45% a year earlier. The company said the increase reflected higher product sales and a favorable change in product mix. It expects full-year 2026 adjusted gross margin to exceed 70%.

GAAP net income was $35.2 million, or $1.06 a share, compared with a net loss of $1.9 million, or $0.07 a share, a year earlier. During the quarter the company released the valuation allowance on its federal and a portion of its state deferred tax assets, producing an income tax benefit. On a non-GAAP basis, after removing that one-time tax benefit, net income was $16.5 million, or $0.50 a share.

General and administrative expenses were $16.0 million, up 98% from $8.1 million a year earlier. The company cited higher stock-based compensation, increased compensation and benefits from additional headcount, higher operating costs to support a larger commercial portfolio, and higher FDA fees after the loss of orphan-drug fee-exemption eligibility. Adjusted G&A, which excludes stock-based compensation, depreciation, transaction-related costs and other one-time items, was $12.8 million. Research and development expenses were $5.3 million, including a $3 million payment for ASN-001 rights and higher spending on Glyburide Oral Suspension.

The company raised 2026 revenue guidance to more than $175 million from more than $145 million, and raised 2026 Adjusted EBITDA margin guidance to more than 40% from more than 35%. Chief executive Sean Brynjelsen said the increases reflected strong momentum in the business. Eton said it expects continued organic growth from its promoted products through the remainder of 2026 and beyond.

All-time high active patient counts were recorded for INCRELEX, HEMANGEOL, ALKINDI SPRINKLE, KHINDIVI, DESMODA and GALZIN. In September the company launched IMPAVIDO in the United States and became the exclusive U.S. distributor. It entered an exclusive license and supply agreement for LIBERVANT, a buccal-film seizure-rescue candidate with Orphan Drug Designation and tentative approval for ages 2 to 5 and 12 and older; an NDA with a March 29, 2027 PDUFA date is under FDA review, and Eton anticipates launching the product in April 2027. The company said the current U.S. market for existing nasal and rectal seizure-rescue treatments is estimated at more than $450 million in annual sales.

The FDA accepted a KHINDIVI Prior Approval Supplement that would expand the indicated age range to children under five, with a May 28, 2027 PDUFA date. A research IND has been submitted for a Phase 2 study of INCRELEX in epileptic spasms, with enrollment expected to begin in the first quarter of 2027. An ET-700 proof-of-concept PET study showed treatment-related adverse events in 1 of 12 participants versus 8 of 12 on GALZIN; hepatic copper uptake decreased 12% with ET-700 versus 46% with GALZIN. The company plans additional 2027 study arms with faster-release formulations. ASN-001, licensed in August, is in a bioavailability study with first dosing expected in January 2027; Eton anticipates an NDA in 2027. An INCRELEX label-harmonization study has started, and a Glyburide Oral Suspension bioavailability study is complete, with an NDA planned near the end of 2026 or early 2027.

Cash and cash equivalents were $55.6 million as of September 30, 2026.