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Ionis Pharmaceuticals IONS reported fourth-quarter 2025 adjusted loss per share of $1.14, narrower than the Zacks Consensus Estimate of a loss of $1.21. In the year-ago period, the company had incurred an adjusted loss of 43 cents.
The adjusted earnings exclude compensation expenses related to equity awards. Including this special item, loss was pinned at $1.41 per share compared with a loss of 66 cents in the year-ago period.
Total revenues were $203 million, which also beat the Zacks Consensus Estimate of about $156 million. Revenues, however, declined 10.6% year over year.
The company has two wholly-owned marketed drugs — Tryngolza for familial chylomicronemia syndrome (FCS) and Dawnzera for hereditary angioedema. Tryngolza was launched in the United States in 2024 and in the EU in late 2025. Dawnzera was launched in the United States last year and approved in the EU in January 2026. To market these drugs across ex-U.S. territories, the company has partnered with Sobi (for Tryngolza) and Otsuka (for Dawnzera).
The company currently has five partnered marketed drugs in its portfolio. These include Spinraza for spinal muscular atrophy and Qalsody in amyotrophic lateral sclerosis (ALS) with superoxide dismutase 1 mutations in partnership with Biogen BIIB; Wainua in partnership with AstraZeneca AZN for treating polyneuropathy caused by hereditary TTR (hATTR) amyloidosis (ATTRv-PN or hATTR-PN); Tegsedi in hATTR amyloidosis; and Waylivra for genetically confirmed FCS. While the company receives royalties from Biogen and AstraZeneca on net sales for Spinraza, Qalsody and Wainua, it earns distribution fees for Tegsedi and Waylivra sales.
Commercial revenues, which include sales of wholly-owned drugs and royalties on partnered drugs, surged 64% year over year to $141 million during the quarter. This growth was primarily driven by higher product sales from Tryngolza. The metric surpassed the Zacks Consensus Estimate of $127 million.
Tryngolza product sales were $50 million, up 56% year over year, driven by a robust launch momentum.
Dawnzera generated $7 million in its first full quarter since launch.
Spinraza royalties totaled $54 million, down 15.6% year over year.
Wainua royalty revenues amounted to $16 million compared with $10 million in the previous quarter. The EU launch for the drug is currently underway.
Ionis recorded $6 million as other royalties compared with $3 million in the previous quarter. This metric also includes royalties from Qalsody.
Though R&D revenues (upfront payments, milestone payments and license fees from partnered medicines) fell 56% year over year to $62 million, the figure still beat the Zacks Consensus Estimate of $25 million.
Collaborative agreement revenues totaled $52 million compared with $97 million in the year-ago quarter. Joint development revenues for Wainua from partner AstraZeneca amounted to $10 million compared with $44 million in the year-ago quarter.
Adjusted operating costs rose 24.6% year over year to $375 million in the quarter. While SG&A costs increased 52% to support commercialization efforts for Wainua, Tryngolza and Dawnzera, R&D costs rose 14% in the quarter.
In 2025, the company reported total revenues of $944 million, up 34% year over year. Total revenues beat the guidance range of $875 million and $900 million. However, total revenues in 2025 included a one-time upfront payment from Ono Pharmaceutical for rights to sapablursen. Adjusted loss per share was $1.54 compared with $2.16 in the year-ago quarter.
The company issued fresh guidance for 2026. It expects total revenues in the range of $800-$825 million. This range suggests year-over-year growth of 20% at the mid-point, excluding the one-time $280 million sapablursen upfront payment in 2025. However, the guidance range fell short of the Zacks Consensus Estimate of $867.3 million.
The soft 2026 guidance probably disappointed investors, leading the stock to decline 5% on Wednesday despite the better-than-expected results for the fourth quarter. The company also signaled a slower product sales uptake for its new drugs, Tryngolza and Dawnzera, in 2026, which hurt investor sentiment.
In the past year, shares of Ionis have soared 158.2% compared with the industry’s 3.5% growth.
The adjusted operating loss is expected to be between $500 million and $550 million, which implies flat growth from 2025 levels, excluding the onetime sapablursen license fee in 2025. Operating expenses are expected to increase in the low-teen percentage range in 2026 compared to last year.
Ionis expects to end the year with cash and investments of approximately $1.6 billion and expects to achieve cash flow breakeven by 2028.
Ionis has also developed Tryngolza for severely elevated triglycerides (sHTG), which is a broader indication than FCS. All three phase III pivotal studies — CORE, CORE2 and ESSENCE- evaluating Tryngolza for sHTG, met their primary goal of statistically significant reductions in triglyceride levels and also achieved a significant reduction in acute pancreatitis events. Based on these results, Ionis submitted a supplemental new drug application (sNDA) seeking approval for expanded use of Tryngolza in sHTG.
The company said that the guidance assumes that the FDA will assign a standard review period for Tryngolza’s sNDA for sHTG which means the FDA decision will come in the fourth quarter. If the FDA gives a priority review designation to the sNDA, the decision will come early and the revenue guidance will increase. The company expects a decline in Tryngolza revenues in 2026 until the sHTG launch, after which sales should pick up.
Some other important wholly-owned candidates in Ionis’ pipeline include zilganersen and obudanersen (previously ION582). An NDA seeking approval of zilganersen for Alexander disease was filed with the FDA in January with a decision expected in the second half of 2026.
Obudanersen is being evaluated in the phase III REVEAL study for treating a rare and serious neurodevelopmental disorder called Angelman syndrome. Data from the study is expected in 2027.
AstraZeneca and Ionis are also developing Wainua for another form of amyloidosis called cardiomyopathy caused by hereditary TTR amyloidosis (ATTR-CM), which has a larger market than ATTRv-PN. Data from the phase III CARDIO-TTRANSform study in ATTR-CM is expected in the second half of 2026.
Pelacarsen, in partnership with Novartis, is being developed in a phase III study called HORIZON for elevated Lp (a)-driven cardiovascular disease. Data from the study is expected in mid-2026.
Ionis’ partner GSK, plc GSK is developing bepirovirsen as a potential treatment for patients with chronic hepatitis B virus. While the drug was invented by Ionis, GSK has global development and marketing rights. Last month, GSK announced positive results from two phase III studies, B-Well 1 and B-Well 2, on bepirovirsen. Both studies met their primary endpoints, demonstrating statistically significant and clinically meaningful functional cure rates. Based on this data, GSK intends to submit regulatory filings globally for the drug in the first quarter of 2026.
Ionis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This article originally published on Zacks Investment Research (zacks.com).
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