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Ionis Beats on Q2 Earnings & Sales, Stock Up 5% on Raised '25 Outlook
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Key Takeaways
IONS posted Q2 EPS of $0.86 and revenue of $452M, both beating estimates and doubling year over year.
Tryngolza and Wainua drove a 43% rise in commercial revenues, reaching $103M for the quarter.
IONS raised its 2025 revenue outlook to $825-$850M, citing strong Tryngolza uptake and market expansion plans.
Ionis Pharmaceuticals (IONS - Free Report) reported second-quarter 2025 adjusted earnings per share (EPS) of 86 cents, significantly beating the Zacks Consensus Estimate of 27 cents. In the year-ago period, the company posted an adjusted loss of 24 cents.
The adjusted earnings exclude compensation expenses related to equity awards. Including this special item, EPS stood at 70 cents against a loss of 45 cents in the year-ago period.
Total revenues were $452 million, which also beat the Zacks Consensus Estimate of $271 million. The reported figure doubled compared to the year-ago period.
Ionis’ Diverse Revenue Stream
Ionis licensed Spinraza to Biogen (BIIB - Free Report) , which is responsible for commercializing it. Spinraza is approved for treating spinal muscular atrophy worldwide. Ionis receives royalties from Biogen on Spinraza’s sales. It also earns royalties from Biogen’s sales of Qalsody, approved for treating amyotrophic lateral sclerosis with superoxide dismutase 1 (SOD1) mutations. Qalsody was launched in the United States in 2023 and in the EU in May 2024.
Ionis and AstraZeneca’s (AZN - Free Report) Wainua (eplontersen) was approved by the FDA in December 2023 for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy, commonly called hATTR-PN or ATTRv-PN. The two companies co-market Wainua for ATTRv-PN in the United States, while AZN holds exclusive rights to commercialize the drug in ex-U.S. markets.
Following Wainua’s U.S. launch, Ionis began receiving royalties from AstraZeneca that are included in commercial revenues. The drug was recently approved in the EU for a similar indication, where it will be marketed as Wainzua.
In December, the FDA approved Ionis’ first wholly owned drug, Tryngolza (olezarsen), the first and only approved treatment for familial chylomicronemia syndrome (FCS), a serious, rare disease. A regulatory filing for this FCS drug is currently under review in the EU, which recently received a positive recommendation from the CHMP. A final decision is expected later this year. Ionis licensed marketing rights for the drug outside the United States, Canada and China to Sobi in March.
IONS' Commercial Revenues Rise
Commercial revenues, which include sales of wholly owned drugs and royalties on partnered drugs, rose 43% year over year to $103 million during the quarter. This upside was largely driven by Tryngolza product sales and Wainua royalties. The metric beat the Zacks Consensus Estimate of $88 million.
Notably, this was the second full quarter in which Ionis recognized product sales for Tryngolza. This drug added $19 million to the company’s top line compared with $6 million in the previous quarter, driven by a robust launch momentum.
Spinraza royalties totaled $54 million, down 5% year over year. The metric missed the Zacks Consensus Estimate of $55 million. Per Ionis, Spinraza sales during the quarter stood at $393 million, suggesting a decline of 8% over the year-ago period.
Wainua royalty revenues amounted to $10 million compared with $9 million in the previous quarter. This drug generated sales of $44 million, as recorded by AstraZeneca. The EU launch for the drug is currently underway.
Ionis recorded $6 million as other royalties. The figure doubled year over year. This metric also includes royalties from Qalsody product sales.
IONS added $14 million from Tegsedi and Waylivra distribution fees during the quarter. The figure surged 75% year over year.
IONS' R&D Revenues Rise
R&D revenues rose 128% year over year to $349 million, which beat the Zacks Consensus Estimate of $183 million. This upside was mainly driven by the receipt of $280 million as an upfront payment for out-licensing rights for a rare blood cancer drug to Japan-based Ono Pharmaceutical.
Collaborative agreement revenues totaled $337 million compared with $141 million in the year-ago quarter. Joint development revenues for Wainua from partner AstraZeneca amounted to $12 million, flat year over year.
IONS' Costs Rise
Adjusted operating costs rose 8% year over year to $282 million in the quarter. While SG&A costs increased 42% to support commercialization efforts for Wainua and Tryngolza, R&D costs declined 1% as several late-stage studies ended.
IONS Raises 2025 Guidance
This marks the second upward revision to Ionis’ 2025 financial outlook. The company now expects total revenues to be between $825 million and $850 million, up from the prior guidance of $725-$750 million. The Zacks Consensus Estimate is pegged at $742 million.
Per Ionis, the revised guidance reflects the encouraging uptake for Tryngolza. The company issued fresh guidance for the drug’s sales for the full year, expected to be between $75-$80 million.
Shares of Ionis were up about 5% yesterday, likely driven by the raised guidance. Year to date, the stock has risen 24% compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
The adjusted operating loss is now expected to be between $300-$325 million, down from the previous guidance of less than $375 million. Adjusted operating expenses are expected to increase in the high single-digit percentage range in 2025, primarily due to higher SG&A costs.
The company now expects to end 2025 with approximately $2.0 billion in cash (previous projection: $1.9 billion).
Update on IONS’ Wholly-Owned Candidates
Tryngolza is also being evaluated in three late-stage studies — CORE, CORE2 and ESSENCE — for severe hypertriglyceridemia, which involves a much larger patient population. While the company recently announced that the ESSENCE study met its primary goal of statistically significant reductions in triglyceride (TG) levels, data from the CORE & CORE2 studies are expected in September. If positive, Ionis plans to submit an FDA filing for the drug’s label expansion before this year’s end.
IONS’ other wholly-owned candidates include donidalorsen and zilganersen. A regulatory filing is currently under FDA review seeking approval of donidalorsen in patients aged 12 years and above with hereditary angioedema (HAE), with a final decision expected next month. If approved, the company expects donidalorsen to be its second independently marketed product. A similar filing has also been submitted in the EU by the company’s partner Otsuka.
Zilganersen is being evaluated in a late-stage study for treating Alexander disease, a rare leukodystrophy with no approved therapies. Data from this study is expected in 2025.
Ionis recently started the phase III REVEAL study evaluating ION582 for treating a rare and serious neurodevelopmental disorder called Angelman syndrome.
Update on IONS’ Partnered Candidates
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.
Among some wholly-owned candidates, Ionis’ partner Novartis (NVS - Free Report) is developing pelacarsen in late-stage studies for elevated Lp(a)-driven CVD, with data expected this year. Along with GSK, the company is developing bepirovirsen as a potential treatment for patients with chronic hepatitis B virus in two ongoing late-stage studies. The studies are now fully enrolled, with data expected in 2026.
The company also announced that AstraZeneca recently started a phase IIb study on opemalirsen for the treatment of APOL1-mediated kidney disease (AMKD). The initiation of this study triggered a milestone payment of $30 million to Ionis.
Image: Bigstock
Ionis Beats on Q2 Earnings & Sales, Stock Up 5% on Raised '25 Outlook
Key Takeaways
Ionis Pharmaceuticals (IONS - Free Report) reported second-quarter 2025 adjusted earnings per share (EPS) of 86 cents, significantly beating the Zacks Consensus Estimate of 27 cents. In the year-ago period, the company posted an adjusted loss of 24 cents.
The adjusted earnings exclude compensation expenses related to equity awards. Including this special item, EPS stood at 70 cents against a loss of 45 cents in the year-ago period.
Total revenues were $452 million, which also beat the Zacks Consensus Estimate of $271 million. The reported figure doubled compared to the year-ago period.
Ionis’ Diverse Revenue Stream
Ionis licensed Spinraza to Biogen (BIIB - Free Report) , which is responsible for commercializing it. Spinraza is approved for treating spinal muscular atrophy worldwide. Ionis receives royalties from Biogen on Spinraza’s sales. It also earns royalties from Biogen’s sales of Qalsody, approved for treating amyotrophic lateral sclerosis with superoxide dismutase 1 (SOD1) mutations. Qalsody was launched in the United States in 2023 and in the EU in May 2024.
Ionis and AstraZeneca’s (AZN - Free Report) Wainua (eplontersen) was approved by the FDA in December 2023 for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy, commonly called hATTR-PN or ATTRv-PN. The two companies co-market Wainua for ATTRv-PN in the United States, while AZN holds exclusive rights to commercialize the drug in ex-U.S. markets.
Following Wainua’s U.S. launch, Ionis began receiving royalties from AstraZeneca that are included in commercial revenues. The drug was recently approved in the EU for a similar indication, where it will be marketed as Wainzua.
In December, the FDA approved Ionis’ first wholly owned drug, Tryngolza (olezarsen), the first and only approved treatment for familial chylomicronemia syndrome (FCS), a serious, rare disease. A regulatory filing for this FCS drug is currently under review in the EU, which recently received a positive recommendation from the CHMP. A final decision is expected later this year. Ionis licensed marketing rights for the drug outside the United States, Canada and China to Sobi in March.
IONS' Commercial Revenues Rise
Commercial revenues, which include sales of wholly owned drugs and royalties on partnered drugs, rose 43% year over year to $103 million during the quarter. This upside was largely driven by Tryngolza product sales and Wainua royalties. The metric beat the Zacks Consensus Estimate of $88 million.
Notably, this was the second full quarter in which Ionis recognized product sales for Tryngolza. This drug added $19 million to the company’s top line compared with $6 million in the previous quarter, driven by a robust launch momentum.
Spinraza royalties totaled $54 million, down 5% year over year. The metric missed the Zacks Consensus Estimate of $55 million. Per Ionis, Spinraza sales during the quarter stood at $393 million, suggesting a decline of 8% over the year-ago period.
Wainua royalty revenues amounted to $10 million compared with $9 million in the previous quarter. This drug generated sales of $44 million, as recorded by AstraZeneca. The EU launch for the drug is currently underway.
Ionis recorded $6 million as other royalties. The figure doubled year over year. This metric also includes royalties from Qalsody product sales.
IONS added $14 million from Tegsedi and Waylivra distribution fees during the quarter. The figure surged 75% year over year.
IONS' R&D Revenues Rise
R&D revenues rose 128% year over year to $349 million, which beat the Zacks Consensus Estimate of $183 million. This upside was mainly driven by the receipt of $280 million as an upfront payment for out-licensing rights for a rare blood cancer drug to Japan-based Ono Pharmaceutical.
Collaborative agreement revenues totaled $337 million compared with $141 million in the year-ago quarter. Joint development revenues for Wainua from partner AstraZeneca amounted to $12 million, flat year over year.
IONS' Costs Rise
Adjusted operating costs rose 8% year over year to $282 million in the quarter. While SG&A costs increased 42% to support commercialization efforts for Wainua and Tryngolza, R&D costs declined 1% as several late-stage studies ended.
IONS Raises 2025 Guidance
This marks the second upward revision to Ionis’ 2025 financial outlook. The company now expects total revenues to be between $825 million and $850 million, up from the prior guidance of $725-$750 million. The Zacks Consensus Estimate is pegged at $742 million.
Per Ionis, the revised guidance reflects the encouraging uptake for Tryngolza. The company issued fresh guidance for the drug’s sales for the full year, expected to be between $75-$80 million.
Shares of Ionis were up about 5% yesterday, likely driven by the raised guidance. Year to date, the stock has risen 24% compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
The adjusted operating loss is now expected to be between $300-$325 million, down from the previous guidance of less than $375 million. Adjusted operating expenses are expected to increase in the high single-digit percentage range in 2025, primarily due to higher SG&A costs.
The company now expects to end 2025 with approximately $2.0 billion in cash (previous projection: $1.9 billion).
Update on IONS’ Wholly-Owned Candidates
Tryngolza is also being evaluated in three late-stage studies — CORE, CORE2 and ESSENCE — for severe hypertriglyceridemia, which involves a much larger patient population. While the company recently announced that the ESSENCE study met its primary goal of statistically significant reductions in triglyceride (TG) levels, data from the CORE & CORE2 studies are expected in September. If positive, Ionis plans to submit an FDA filing for the drug’s label expansion before this year’s end.
IONS’ other wholly-owned candidates include donidalorsen and zilganersen. A regulatory filing is currently under FDA review seeking approval of donidalorsen in patients aged 12 years and above with hereditary angioedema (HAE), with a final decision expected next month. If approved, the company expects donidalorsen to be its second independently marketed product. A similar filing has also been submitted in the EU by the company’s partner Otsuka.
Zilganersen is being evaluated in a late-stage study for treating Alexander disease, a rare leukodystrophy with no approved therapies. Data from this study is expected in 2025.
Ionis recently started the phase III REVEAL study evaluating ION582 for treating a rare and serious neurodevelopmental disorder called Angelman syndrome.
Update on IONS’ Partnered Candidates
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.
Among some wholly-owned candidates, Ionis’ partner Novartis (NVS - Free Report) is developing pelacarsen in late-stage studies for elevated Lp(a)-driven CVD, with data expected this year. Along with GSK, the company is developing bepirovirsen as a potential treatment for patients with chronic hepatitis B virus in two ongoing late-stage studies. The studies are now fully enrolled, with data expected in 2026.
The company also announced that AstraZeneca recently started a phase IIb study on opemalirsen for the treatment of APOL1-mediated kidney disease (AMKD). The initiation of this study triggered a milestone payment of $30 million to Ionis.
Ionis Pharmaceuticals, Inc. Price
Ionis Pharmaceuticals, Inc. price | Ionis Pharmaceuticals, Inc. Quote
IONS’ Zacks Rank
Ionis currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.