Ionis Pharmaceuticals IONS incurred a loss of 66 cents per share for fourth-quarter 2024, which was narrower than the Zacks Consensus Estimate of a loss of $1.12 per share.
Earnings included compensation expenses related to equity awards. Excluding these special items, adjusted loss per share was 43 cents against a gain of 12 cents per share in the year-ago quarter.
Total revenues were $227 million in the fourth quarter, beating the Zacks Consensus Estimate of $137.5 million. However, revenues declined 30.2% year over year.
In the past year, Ionis’ shares have declined 26.9% compared with the industry’s decrease of 10.2%.
Zacks Investment Research
Image Source: Zacks Investment Research
IONS’ Different Sources of Revenues
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 and Biogen also market Qalsody (tofersen) 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 outside U.S. markets.
With the launch of Wainua in the United States, Ionis receives royalties from AstraZeneca, which is included in commercial revenues. Wainua is under review in the EU.
In December 2024, the FDA approved Ionis’ first wholly-owned drug, Tryngolza (olezarsen), an RNA-targeted therapy, for treating familial chylomicronemia syndrome, a serious rare disease for which no treatments were approved in the United States until now. The drug was launched in the United States in late December. A marketing authorization application is also under review in the EU.
IONS' Commercial Revenues Rise
Commercial revenues were $86 million in the fourth quarter, up 8.9% year over year. Commercial revenues beat the Zacks Consensus Estimate of $81 million.
Commercial revenues from Spinraza royalties were $64 million, up 1.6% year over. Spinraza sales, as recorded by Biogen, were $421.4 million, up 2% year over year. Spinraza royalties beat the Zacks Consensus Estimate of $61 million.
In the quarter, Wainua royalty revenues were $10 million. Wainua generated sales of $42 million in the fourth quarter, as recorded by AstraZeneca, up 84% on a sequential basis. Ionis said that Wainua delivered accelerating sequential growth throughout 2024 on strong uptake.
Other commercial revenues were $12 million compared with $17 million in the year-ago quarter.
Other commercial revenues included revenues from Tegsedi and Waylivra distribution fees and license and royalty revenues. License and royalty revenues also included royalties from Qalsody U.S. product sales.
IONS' R&D Revenues Decline
R&D revenues declined 42.7% year over year to $141 million. R&D revenues beat the Zacks Consensus Estimate of $57 million.
Collaborative agreement revenues were $97 million in the quarter compared with $179 million in the year-ago quarter. Joint development revenues for Wainua from partner AstraZeneca were $44 million in the quarter compared with $67 million in the year-ago quarter.
IONS' Costs Decline
Adjusted operating costs declined 1.3% year over year to $301 million in the quarter. SG&A costs rose 18.5% to support the launches of Wainuaand Tryngolza. R&D costs declined 7.2% in the quarter as several late-stage studies ended.
IONS’ Full-Year 2024 Results
In 2024, Ionis incurred a loss of $3.04 per share, which was narrower than the Zacks Consensus Estimate of a loss of $3.47 per share. The loss in the year-ago quarter was $2.56 per share.
Total revenues were $705 million in 2024, beating the Zacks Consensus Estimate of $618.6 million. Revenues declined 10.5% year over year. Revenues also beat the company’s guidance of more than $575 million in 2024.
IONS Issues 2025 Guidance
Ionis issued fresh financial guidance for 2025. The company expects total revenues to be more than $600 million in 2025. The Zacks Consensus Estimate stands at $675.1 million. Ionis expects its revenues to shift toward increasing commercial revenues. R&D revenues are expected to be lower than the 2024 level with most of it coming in the second half.
Adjusted operating loss is expected to be 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 2024 levels.
The company expects to end 2025 with approximately $1.7 billion in cash.
Update on IONS’ Wholly-Owned Candidates
Olezarsen is also being evaluated in three late-stage studies for severe hypertriglyceridemia, which involves a much larger patient population. Enrollment has been completed in these studies, and data are expected in the second half of 2025.
IONS’ other wholly-owned candidates are donidalorsen and zilganersen.
In November, the FDA accepted Ionis’ NDA seeking approval of donidalorsen for treating hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. HAE is a rare and potentially life-threatening genetic condition. The FDA decision on the NDA is expected on Aug. 21, 2025.
Management expects donidalorsen to be its second independent commercial launch. Additionally, Ionis’ partner, Otsuka, submitted a regulatory application in the EU.
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 begin in the first half 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.
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.
Ionis Pharmaceuticals, Inc. Price and Consensus
Ionis Pharmaceuticals, Inc. Price and Consensus
Ionis Pharmaceuticals, Inc. price-consensus-chart | Ionis Pharmaceuticals, Inc. Quote
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report