Ionis Pharmaceuticals lost 95 cents per share in Q3, less than the estimated loss of $1.16.
Total revenues for the company the last quarter was $134 million, a 7% decrease from last year.
Register now to see our 7 Best Stocks for the Next 30 Days report - free today!
Ionis Pharmaceuticals IONS incurred a loss of 95 cents per share for third-quarter 2024, which was narrower than the Zacks Consensus Estimate of a loss of $1.16 per share.
Earnings include compensation expenses related to equity awards. Excluding these special items, adjusted loss per share was 72 cents compared with a loss of 85 cents per share in the year-ago quarter.
Total revenues were $134 million in the third quarter, beating the Zacks Consensus Estimate of $129.0 million. Revenues declined 7% year over year.
Year to date, Ionis’ shares have declined 22.9% compared with the industry’s decrease of 3.6%.
Image Source: Zacks Investment Research
IONS' Commercial Revenues Decline
Ionis licensed Spinraza to Biogen BIIB, which is responsible for commercializing it. Spinraza is approved for treating spinal muscular atrophy, or SMA, worldwide. Ionis receives royalties from Biogen on Spinraza’s sales. Ionis and Biogen also market Qalsody (tofersen) for amyotrophic lateral sclerosis (ALS) 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. Applications seeking approval of Wainua for ATTRv-PN are under review in the EU with a decision expected this year. In the reported quarter, the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion recommending approval of Wainua. Wainua was also approved in the United Kingdom in the quarter, resulting in a $30 million milestone payment from AstraZeneca.
Commercial revenues were $76 million in the third quarter, down 1.2% year over year. Commercial revenues missed the Zacks Consensus Estimate of $80 million.
Commercial revenues from Spinraza royalties were $57 million, down 15% year over. Spinraza sales, as recorded by Biogen, were $381.4 million, down 15% year over year. Spinraza royalties missed the Zacks Consensus Estimate of $62 million.
In the third quarter, Wainua royalty revenues were $5 million. Wainua generated sales of $23 million in the third quarter, as recorded by AstraZeneca, up 44% on a sequential basis. Other commercial revenues were $14 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 3.3% year over year to $58 million. R&D revenues beat the Zacks Consensus Estimate of $49.8 million.
Collaborative agreement revenues were $45 million in the quarter compared with $44 million in the year-ago quarter. Joint development revenues for Wainua from partner AstraZeneca were $13 million in the quarter compared with $16 million in the year-ago quarter.
IONS Costs Decline
Adjusted operating costs declined 4.2% year over year to $250 million in the quarter due to a one-time cost incurred in the third quarter of 2023. Excluding this one-time cost, operating expenses rose mainly due to higher SG&A costs for go-to-market activities for Wainua, olezarsen and donidalorsen. R&D costs were almost flat in the quarter as several late-stage studies ended.
IONS Keeps 2024 Guidance
Ionis maintained its financial guidance for 2024. The company expects total revenues to be more than $575 million in 2024. Adjusted operating loss is expected to be less than $475 million. Adjusted operating expenses are expected to increase in the mid-single-digit range year over year in 2024, primarily due to higher SG&A costs. The company expects to end 2024 with $2.2 billion in cash.
Update on IONS’ Wholly-Owned Candidates
Some of IONS’ wholly-owned candidates include olezarsen, donidalorsen and zilganersen.
Ionis’ new drug application (NDA) seeking approval for olezarsen for familial chylomicronemia syndrome, a serious rare disease with no treatments approved in the United States, is under review with the FDA. The NDA is based on results from the phase III BALANCE study. If approved, olezarsen will be Ionis’ first medicine that will be launched independently. A final decision from the FDA is expected on Dec. 19, 2024. A marketing authorization application (MAA) is also under review in the EU.
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.
Earlier this week, Ionis announced that the FDA has accepted its 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 NDA was based on data from two phase III studies — OASIS-HAE and OASISplus. 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, is preparing to submit a MAA in Europe soon.
Zilganersen is being evaluated in a phase III study for treating Alexander disease, a type of leukodystrophy. Data from the study is expected in 2025. In the quarter, the FDA granted Fast Track designation to zilganersen for Alexander disease.
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. Along with the earnings results, Ionis said that following positive results for ION582 in the phase II HALOS study, it has reached alignment with the FDA on the design of its phase III REVEAL study. The study’s primary endpoint will be Bayley-4 expressive communication. which will assess improvement in expressive communication.
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, delayed from prior expectation of first half of 2025.
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 next 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-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