Ionis Pharmaceuticals IONS reported first-quarter 2025 adjusted loss of 75 cents per share, narrower than the Zacks Consensus Estimate of a loss of $1.11. In the year-ago period, the company posted an adjusted loss of 77 cents.
The adjusted loss excludes compensation expenses related to equity awards. Including this special item, loss per share was 93 cents compared with a loss of 98 cents in the year-ago quarter.
Total revenues were $132 million, which beat the Zacks Consensus Estimate of $120 million. The reported figure rose 11% year over year. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar)
Ionis’ Diverse Revenue Stream
Ionis licensed Spinraza to Biogen BIIB, which is responsible for commercializing it. Spinraza is approved for treating spinal muscular atrophy worldwide. Ionis receives royalties from Biogen on Spinraza’s sales. Ionis also earns royalties from Biogen’s sales of Qalsody, an approved treatment for 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 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. AstraZeneca and Ionis co-market Wainua for ATTRv-PN in the United States. AstraZeneca has exclusive rights to commercialize Wainua 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), an RNA-targeted therapy, for treating familial chylomicronemia syndrome (FCS), a serious rare disease for which no treatment has been approved in the United States until now. A regulatory filing for the drug is currently under review in the EU, with a final decision expected in the second half of 2025. Ionis recently licensed marketing rights for the drug outside the United States, Canada and China to Sobi.
IONS' Commercial Revenues Rise
Commercial revenues totaled $76 million in the first quarter, up 29% year over year. This metric beat the Zacks Consensus Estimate of $67 million. This figure includes Tryngolza product sales and royalties on sales of partnered drugs.
Notably, this was the first quarter when Ionis recognized product sales for Tryngolza. This drug added $6 million to the company’s top line. Per Ionis, this sales number exceeded its expectations.
Spinraza royalties totaled $48 million, up 26% year over year. The metric beat the Zacks Consensus Estimate of $43 million. Per Ionis, Spinraza sales rose 25% year over year to $424 million.
Wainua royalty revenues amounted to $9 million compared with $10 million in the previous quarter. This drug generated sales of $39 million, as recorded by AstraZeneca. The EU launch for the drug is currently underway.
Ionis recorded $7 million as other royalties. The figure declined 30% year over year. This metric also includes royalties from Qalsody product sales.
IONS added $6 million from Tegsedi and Waylivra distribution fees during the quarter. The figure dropped 33% year over year.
IONS' R&D Revenues Decline
R&D revenues declined 7% year over year to $56 million, which beat the Zacks Consensus Estimate of $50 million.
Collaborative agreement revenues totaled $46 million compared with $49 million in the year-ago quarter. Joint development revenues for Wainua from partner AstraZeneca amounted to $10 million compared with $11 million in the year-ago period.
IONS' Costs Rise
Adjusted operating costs rose 5% year over year to $249 million in the quarter. While SG&A costs surged 52% to support commercialization efforts for Wainua and Tryngolza, R&D costs declined 6% as several late-stage studies ended.
IONS Raises 2025 Guidance
Ionis revised its financial guidance for 2025. The company now expects total revenues to be between $725 million and $750 million, up from the prior guidance of over $600 million. This rise in sales guidance reflects upfront payments from new licensing deals signed during the first quarter. The Zacks Consensus Estimate is pegged at $637.6 million.
Shares of Ionis were up 3% yesterday, likely due to the raised guidance. Year to date, the stock fell 12% compared with the industry’s 3% decline.
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Adjusted operating loss is now expected to be less than $375 million compared with the previous guidance of less than $495 million. Adjusted operating expenses are expected to increase in the high single-digit percentage range in 2025 due to higher SG&A costs. SG&A costs are expected to increase as the company invests in go-to-market activities for Tryngolza and the potential launch of donidalorsen. R&D costs are expected to be similar to the 2024 levels.
The company now expects to end 2025 with approximately $1.9 billion in cash (previous projection: $1.7 billion).
Update on IONS’ Wholly Owned Candidates
Tryngolza is also being evaluated in three late-stage studies for severe hypertriglyceridemia, which involves a much larger patient population. While data from one study is expected in second-quarter 2025, Ionis intends to report data from the other two studies in the third quarter. If data from these studies are positive, the company plans to submit an FDA filing for the drug’s label expansion before this year’s end.
IONS’ other wholly-owned candidates are donidalorsen and zilganersen. Last November, the FDA accepted Ionis’ regulatory filing seeking approval of donidalorsen for treating hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. A final decision is expected by Aug. 21, 2025. 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 phase III study for treating Alexander disease, a rare leukodystrophy with no approved therapies. Data from the study is expected in 2025.
A global pivotal phase III study on another candidate, ION582, for treating Angelman syndrome, a rare disorder, is expected to start in the second quarter of 2025.
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 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.
In March, Ionis announced that it has out-licensed rights for a rare blood cancer drug to Japan-based Ono Pharmaceutical. In consideration of granting these rights, Ionis will receive an upfront payment of $280 million from Ono. The company will also be eligible for milestone payments of up to $660 million and royalties on future sales of the drug.
Ionis Pharmaceuticals, Inc. Price
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.
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