Ionis Lifts Sales Outlook After FDA Broadens TRYNGOLZA Label
The biotech raised its 2026 revenue forecast by $75 million after total revenue nearly doubled year-over-year to $246 million in the first quarter.
Ionis Pharmaceuticals (IONS) reported first-quarter 2026 total revenue of $246 million, an 87% increase from $132 million a year earlier, as the company capitalized on a broadened FDA label for its cholesterol drug TRYNGOLZA and milestone payments from its partnership pipeline. The quarter marked a turning point for the company's commercial ambitions, arriving just weeks after regulators approved TRYNGOLZA (olezarsen) for severe hypertriglyceridemia (sHTG), a condition affecting more than three million people in the U.S. and a market far larger than the drug's prior familial chylomicronemia syndrome (FCS) indication.
The expanded label prompted Ionis to raise its long-term peak net sales guidance for olezarsen to more than $3 billion, up from a prior target of more than $2 billion, reflecting what the company described as increased confidence in the sHTG opportunity. It is Ionis' first independent launch into a prevalent disease, a milestone for a company historically reliant on partnership royalties and milestone payments to fund its antisense drug platform.
Product sales provided the clearest signal of the company's evolving revenue mix. Total product sales surged to $43 million from $6 million a year ago, with TRYNGOLZA contributing $27 million and DAWNZERA (donidalorsen), a treatment for hereditary angioedema, adding $16 million in its first full quarter on the market. DAWNZERA's sales represented a 125% increase from the fourth quarter of 2025, underscoring early prescription momentum. Commercial revenue overall rose 42% to $108 million.
Research and development revenue more than doubled to $138 million, buoyed by roughly $95 million in milestone payments from multiple partners. Legacy royalty streams told a different story: SPINRAZA global sales generated $44 million in royalty revenue, down from $48 million a year ago, while WAINUA royalties edged up to $11 million from $9 million.
The top-line gains flowed through to the bottom line. Ionis' GAAP net loss narrowed to $93 million, or $0.56 a share, from $147 million, or $0.93 a share, in the year-ago quarter; on a non-GAAP basis the loss shrank to $50 million from $118 million. Operating expenses, however, climbed sharply as the company built out its commercial infrastructure. Selling, general and administrative costs nearly doubled to $151 million, driven by launch spending for TRYNGOLZA and DAWNZERA and preparation costs for the sHTG expansion and the upcoming zilganersen filing.
Management raised full-year 2026 total revenue guidance by $75 million to a range of $875 million to $900 million and lowered its non-GAAP operating loss forecast to $425 million to $475 million, from a prior range of $500 million to $550 million. The company also introduced product-level guidance for the first time, projecting TRYNGOLZA net sales of $100 million to $110 million and DAWNZERA net sales of $110 million to $120 million for the year.
Beyond its own products, Ionis pointed to progress in its partnered pipeline. GSK's bepirovirsen achieved a 19% functional cure rate in the overall chronic hepatitis B population in pivotal B-Well trials, rising to 26% among patients with lower viral activity, compared with zero for placebo; the first regulatory decisions are expected in the third quarter of 2026. Separately, zilganersen met its primary endpoint in a pivotal study of Alexander disease, showing statistically significant stabilization of gait speed, and carries a PDUFA target date of September 22, 2026.
Cash and short-term investments stood at $1.9 billion at quarter-end, down from $2.7 billion at the start of the year, a decline driven primarily by the $633 million maturity of zero-percent convertible notes.