Eton Pharmaceuticals Revenue Jumps 158% to $57.9 Million in Third Quarter

Key Facts

Eton Pharmaceuticals said on November 5 that revenue reached $57.9 million in the third quarter ended September 30, 2026, up 158% year over year. The company said revenue in the year-earlier period was $22.5 million. It attributed the increase to the addition of Hemangeol sales, along with higher sales of Increlex, Alkindi Sprinkle, Khindivi, Galzin, Desmoda and carglumic acid. The company said it recorded record numbers of active patients across its key products, including Hemangeol, Increlex, Alkindi Sprinkle, Khindivi, Galzin and Desmoda. Third-quarter revenue also included $1.2 million in sales of Increlex and Galzin outside the United States. The figures place higher sales and a broader product base among the main factors the company cited for quarterly growth.

Gross profit rose to $44.3 million from $7.9 million in the third quarter of 2025, an increase of 464%. The company said the increase was primarily driven by higher product sales and an improved product mix. Adjusted EBITDA margin was 49%, compared with 13% a year earlier and 43% in the second quarter of 2026. Adjusted EBITDA was $28.5 million, versus $2.9 million in the year-earlier period. Unadjusted EBITDA was $24.8 million, up from $0.3 million. The higher margin than in the previous quarter reflects further improvement during the period, alongside growth in revenue and gross profit.

The company posted GAAP net income of $35.2 million, or $1.06 per diluted share, compared with a net loss of $1.9 million, or $0.07 per share, a year earlier. It said the release of a valuation allowance on deferred tax assets contributed to a one-time tax benefit. Excluding that benefit, non-GAAP net income was $16.5 million, or $0.50 per diluted share. That measure was $1.5 million, or $0.04 per share, in the third quarter of 2025. The comparison shows that reported net income included an exceptional tax effect, while non-GAAP income also increased from a year earlier. Cash and cash equivalents totaled $55.6 million on September 30, 2026.

Eton raised its 2026 revenue outlook to more than $175 million, from a previous target of more than $145 million. It also raised the lower end of its adjusted EBITDA margin forecast to 40%, from 35% previously. The company said it expects adjusted gross margin for the year to exceed 70%. Chief Executive Sean Brynjelsen added that the company surpassed its $200 million annualized revenue run-rate target five quarters ahead of schedule. Brynjelsen described the quarter as a record, citing the 49% adjusted EBITDA margin. The new outlook raises both the revenue target and the margin floor.

On development, the company said research and development expenses were $5.3 million in the third quarter, compared with $1.1 million a year earlier. It attributed the increase primarily to a $3 million payment for rights to drug candidate ASN-001 and higher spending on development of an oral glyburide suspension. General and administrative expenses rose 98% to $16 million from $8.1 million. Factors cited by the company included stock-based compensation, hiring, operating costs and Food and Drug Administration fees after it lost its orphan drug fee waiver. The company also presented proof-of-concept study data for candidate ET-700; treatment-related adverse events were recorded in one of 12 participants, compared with 8 of 12 with Galzin. Hepatic copper absorption fell 12% with ET-700 and 46% with Galzin, while rising 11% with placebo.

The company plans to add study arms for candidate ET-700 in 2027 to evaluate faster-release formulations. It expects the first participant to be dosed in the bioavailability study of candidate ASN-001 in January 2027 and is targeting a new drug application submission within the same year. This comes alongside specified regulatory dates for other products in its portfolio. March 29, 2027, was set as the decision date for the Liberfant application, and the company expects to launch it in April if approved. May 28, 2027, was set as the decision date for the Khindivi label expansion application. These dates tie part of the company's future plans to FDA decisions and the outcomes of the development programs it has announced.