Eton Raises 2026 Revenue Outlook to More Than $175 Million After 158% Quarterly Growth

Key Facts

Eton Pharmaceuticals raised its fiscal 2026 revenue outlook to more than $175 million, from previous guidance of more than $145 million, in its third-quarter results announcement on November 5. The change followed a rise in quarterly revenue to $57.9 million, up 158% from $22.5 million in the same period of 2025. Chief Executive Officer Sean Brynjelsen said the company was raising its revenue and adjusted EBITDA margin outlook "reflecting the strong momentum in our business." The company also raised its 2026 adjusted EBITDA margin outlook to at least 40%, compared with previous guidance of at least 35%. Brynjelsen said the company surpassed its $200 million annualized revenue run rate target five quarters ahead of schedule.

Third-quarter results followed an acceleration in year-over-year revenue growth from 99% in the second quarter, when revenue was $37.6 million versus $18.9 million a year earlier. For the nine months ended September 30, the company reported total revenue of $119.8 million, compared with $58.7 million in the same period of 2025. The company attributed sales growth to the addition of HEMANGEOL revenue and higher sales of INCRELEX, ALKINDI SPRINKLE, KHINDIVI, GALZIN, DESMODA and carglumic acid. It said active patient counts for key products it promotes reached record levels during the quarter, and it expects organic growth to continue through the rest of 2026 and beyond. Quarterly revenue also included $1.2 million from INCRELEX and GALZIN sales outside the United States.

Revenue growth was accompanied by an improvement in gross profit, which reached $44.3 million in the third quarter, compared with $7.9 million in the same period a year earlier, an increase of 464%. The company attributed this mainly to higher product sales and an improved sales mix. Adjusted EBITDA margin was 49%, compared with 13% in the third quarter of 2025 and 43% in the second quarter of 2026. Adjusted gross margin also rose to 80% from 45% a year earlier, and the company expects it to exceed 70% for fiscal 2026. These figures reflect expanding margins alongside higher sales, while the company’s annual outlook includes a further improvement in adjusted EBITDA margin.

Third-quarter net income was $35.2 million, or $1.06 per diluted share, compared with a loss of $1.9 million, or $0.07 per share, a year earlier. The company said the release of a valuation allowance on deferred tax assets resulted in a tax benefit during the period. Excluding this effect, the company reported net income of $16.5 million, or $0.50 per diluted share, on its non-GAAP measure. That measure was $1.5 million, or $0.04 per share, in the third quarter of 2025. Research and development expenses rose to $5.3 million from $1.1 million, with part of the increase attributable to a $3 million payment for ASN-001 rights.

General and administrative expenses rose 98% to $16 million in the third quarter from $8.1 million in the same period a year earlier. The company attributed the increase to compensation, hiring, costs of supporting a larger commercial portfolio and U.S. Food and Drug Administration fees. Cash and cash equivalents, meanwhile, stood at $55.6 million on September 30, 2026. Upcoming product plans include LIBERVANT, whose supplemental application is under review by the FDA, with March 29, 2027, set as the target date for a regulatory decision. If approved, the application could add the 6-to-11-year-old age group to the drug’s label; the company expects to launch it in April 2027.

The company estimated the U.S. market for seizure rescue therapies at more than $450 million in annual sales, in the context of its plan to launch LIBERVANT after the expected regulatory decision. It also announced results from the proof-of-concept study of ET-700: treatment-related adverse events occurred in one of 12 participants, compared with eight of 12 with GALZIN, and hepatic copper absorption fell 12% with ET-700. In another program, the company expects to begin enrolling and dosing patients in a Phase 2 trial of INCRELEX for infantile spasms during the first quarter of 2027. The company’s shares closed at $47.15 on November 5. According to the schedule announced by the company, upcoming milestones include the LIBERVANT regulatory decision in March, the expected launch in April and the start of the INCRELEX trial during the first quarter of the same year.