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Eton Pharmaceuticals Reports Third Quarter 2026 Financial Results

ETON
  • Eton Pharmaceuticals reported record Q3 2026 revenue of $57.9 million, representing 158% year-over-year growth.
  • The company surpassed its $200 million annualized revenue run rate goal five quarters ahead of schedule.
  • GAAP fully diluted EPS for the quarter was $1.06, while non-GAAP fully diluted EPS was $0.50.
  • EBITDA reached $24.8 million, with Adjusted EBITDA at $28.5 million, reflecting a 49% margin of revenue.
  • Management raised 2026 revenue guidance to over $175 million from the previous forecast of over $145 million.
  • The 2026 Adjusted EBITDA guidance was increased to over 40%, up from the prior guidance of over 35%.
  • Active patient counts reached record levels across key products including HEMANGEOL, INCRELEX, ALKINDI SPRINKLE, KHINDIVI, GALZIN, DESMODA, LIBERVANT, IMPAVIDO, Carglumic Acid, Betaine Anhydrous, Nitisinone, PKU GOLIKE.
  • A new ET-900 program evaluating mecasermin for infantile epileptic spasms was initiated with a Phase 2 study expected to begin in Q1 2027.
  • The ET-700 pilot study showed a lower adverse event rate than GALZIN, with plans for additional study arms in 2027.
  • The FDA accepted the KHINDIVI label expansion Prior Approval Supplement with a PDUFA date set for May 28, 2027.
  • Eton acquired U.S. rights to ASN-001 for infantile hemangiomas, with a bioavailability study underway and an NDA expected in 2027.
  • An exclusive license for LIBERVANT was secured to expand into the neurology sector, with a launch anticipated in April 2027.
  • IMPAVIDO was launched in the U.S. in September with expanded patient access support.
  • An INCRELEX label expansion study was initiated to harmonize U.S. definitions of severe primary IGF-1 deficiency.
  • A bioavailability study for Glyburide Oral Suspension was completed, with an NDA submission expected by the end of 2026 or early 2027.
  • Research and development expenses increased to $5.3 million due to ASN-001 acquisition costs.
  • General and administrative expenses rose to $16.0 million driven by stock-based compensation, headcount growth, FDA fees, and operating costs.
  • The company ended the quarter with $55.6 million in cash and cash equivalents.
  • A conference call to discuss these results is scheduled for November 5, 2026, at 4:30 p.m. ET.
Company
Eton Pharmaceuticals
Keywords
Nasdaq:ETON, Eton Pharmaceuticals