Eton Sets $57.9 Million Sales Record And Lifts Its 2026 Revenue Outlook
The rare-disease drug company expects more than $175 million in annual sales and an adjusted earnings margin of at least 40%.
Eton Pharmaceuticals, which develops and sells rare-disease treatments, raised its 2026 sales forecast Thursday to more than $175 million, replacing its previous outlook of more than $145 million, according to its earnings announcement. Record third-quarter revenue of $57.9 million put the company above its $200 million annualized sales-rate goal five quarters earlier than planned.
More Sales, Wider Margins
Third-quarter revenue rose 158% from $22.5 million a year earlier. Eton attributed the increase to added HEMANGEOL sales and growth in INCRELEX, ALKINDI SPRINKLE, KHINDIVI, GALZIN, DESMODA and Carglumic Acid; sales of INCRELEX and GALZIN outside the United States contributed $1.2 million.
Higher sales and a better product mix lifted gross profit to $44.3 million, up 464% from $7.9 million. Adjusted gross margin, excluding acquired-inventory accounting adjustments and intangible amortization, reached 80% against 45% a year earlier; Eton expects that measure to exceed 70% for the full year.
Adjusted earnings before interest, taxes, depreciation and amortization reached $28.5 million, versus $2.9 million a year earlier. That represented 49% of sales, compared with 13% in the prior-year quarter and 43% in the second quarter. Eton now expects a full-year adjusted margin of at least 40%, replacing its floor of 35%.
Reported net income of $35.2 million, or $1.06 per diluted share, included a one-time tax benefit from reversing allowances against deferred tax assets. A year earlier, Eton lost $1.9 million, or $0.07 per share. Excluding the benefit and other adjustments, quarterly profit was $16.5 million, or $0.50 per diluted share, against $1.5 million, or $0.04, a year earlier.
Growth Costs More, Too
Research and development spending reached $5.3 million, versus $1.1 million a year earlier, including a $3 million payment for ASN-001 rights and increased work on Glyburide Oral Suspension. General and administrative costs rose 98% to $16.0 million from $8.1 million, with Eton citing stock-based pay, additional staff, portfolio expansion and higher FDA fees after losing its orphan-drug fee exemption. Adjusted administrative costs were $12.8 million against $6.9 million.
Eton ended September with $55.6 million in cash and cash equivalents. Operating cash flow for the first nine months totaled $49.901 million, versus $22.075 million a year earlier; the company spent $18.225 million on product license rights and repaid $8 million of debt during that period.
The commercial business recorded its highest active-patient counts for INCRELEX, HEMANGEOL, ALKINDI SPRINKLE, KHINDIVI, DESMODA and GALZIN. Eton also launched IMPAVIDO in the United States in September as its exclusive distributor, extending Eton Cares patient support, and exhibited at IDWeek, the Infectious Disease Society’s annual meeting, in October.
Neurology And The 2027 Pipeline
Eton’s exclusive license and supply agreement for LIBERVANT adds a potential seizure-rescue treatment using a film placed inside the cheek, an alternative to nasal and rectal treatments if approved. Eton estimates the current U.S. market exceeds $450 million in annual sales.
Sean Brynjelsen, Eton’s CEO, said LIBERVANT “will expand us into neurology, giving us an additional therapeutic platform to build on with future transactions.” The product has orphan-drug designation and tentative approval for ages 2 to 5 and 12 and older. An application to add ages 6 to 11 has an FDA target decision date of March 29, 2027; Eton anticipates an April launch.
KHINDIVI’s application to include children under five is under FDA review, with a May 28, 2027 target decision date. Eton anticipates launching the expanded indication shortly after approval, if granted. Its INCRELEX study seeks to align U.S. and European definitions of severe primary insulin-like growth factor 1 deficiency; success could expand the estimated eligible U.S. population from 200 to 1,000 patients.
Eton licensed Baylor College of Medicine patent rights for insulin-like growth factor 1 in infantile and epileptic spasms. The company submitted an application for a mid-stage INCRELEX trial and anticipates enrolling and dosing patients in the first quarter of 2027.
ASN-001, whose U.S. rights Eton bought in August, adds to its infantile-hemangioma business alongside HEMANGEOL. Eton expects the first participant in its bioavailability study to receive a dose in January 2027 and anticipates an FDA approval application that year. Glyburide Oral Suspension completed its bioavailability study and has FDA Fast Track designation; Eton targets an application near year-end 2026 or early 2027, with potential approval and launch in 2027.
The ET-700 pilot study delivered a mixed result: treatment-related adverse events affected 1 of 12 participants, compared with 8 of 12 receiving GALZIN, but liver copper uptake fell 12% with ET-700 against 46% with GALZIN. Placebo recipients recorded an 11% increase.
Eton plans additional ET-700 study arms in 2027 to test faster-release formulations, seeking better copper-absorption inhibition while retaining the favorable safety profile.
Sources
- 8-K Filing — Eton Pharmaceuticals, Inc. (ETON) — SEC EDGAR
- Exhibit eton-2026q332026xexx991.htm — Eton Pharmaceuticals, Inc. 8-K exhibit — SEC EDGAR
- Eton Pharmaceuticals Q3 2026 Earnings Call Transcript — benzinga.com
- Eton Pharmaceuticals Reports Third Quarter 2026 Financial — globenewswire.com
