Ionis Pharmaceuticals IONS incurred a loss of 45 cents per share for second-quarter 2024, which was narrower than the Zacks Consensus Estimate of a loss of 95 cents per share.
Earnings include compensation expenses related to equity awards. Excluding these special items, adjusted loss per share was 24 cents against a loss of 40 cents per share in the year-ago quarter.
Total revenues were $225 million in the second quarter, which beat the Zacks Consensus Estimate of $147.0 million. Revenues rose 20% year over year.
Ionis stock rose 3.8% on Thursday, driven by its strong revenue performance.
Year to date, Ionis’ shares have risen 1.4% against the industry’s decrease of 3.8%.
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Quarter in Detail
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 the second quarter of 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, while 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 from the first quarter of 2024. Wainua was approved in Canada in the second quarter. Applications seeking approval of Wainua for ATTRv-PN are under review in the EU with a decision expected this year.
Commercial revenues were $72 million in the second quarter, down 7.7% year over year. Commercial revenues beat the Zacks Consensus Estimate of $68 million.
Commercial revenues from Spinraza royalties were $57 million, down 1.6% year over. Spinraza sales, as recorded by Biogen, improved 25% on a sequential basis on growth in both U.S. and ex-U.S. markets. Spinraza royalties were in line with the Zacks Consensus Estimate.
In the second quarter, Wainua royalty revenues were $4 million. Wainua generated sales of $16 million in the second quarter, as recorded by AstraZeneca. Other commercial revenues were $11 million compared with $17 million in the year-ago quarter.
Other commercial revenues include revenues from Tegsedi and Waylivra distribution fees and license and royalty revenues. License and royalty revenues also include royalties from Qalsody U.S. product sales.
R&D revenues rose 39% year over year to $153.0 million, primarily due to the amortization of upfront payments from new collaborations with Roche and Novartis signed last year. R&D revenues significantly beat the Zacks Consensus Estimate of $63 million.
Collaborative agreement revenues were $141 million in the quarter compared with $90 million in the year-ago quarter. Joint development revenues for Wainua from partner AstraZeneca were $12 million in the quarter compared with $20 million in the year-ago quarter.
Adjusted operating costs rose 3.2% year over year to $260 million in the quarter, mainly due to higher SG&A costs for go-to-market activities for Wainua, olezarsen and donidalorsen. R&D costs declined in the quarter as several late-stage studies ended.
2024 Guidance
Ionis maintained its financial guidance for 2024. The company expects total revenues to be more than $575 million in 2024. Total revenues in the second half are expected to be slightly lower than the first half and weighted more toward the fourth quarter. Commercial revenues are expected to be higher in the second half due to the launch uptake of Wainua and Qalsody and higher anticipated royalties from Spinraza. However, R&D revenues are expected to be lower in the second half.
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.
Pipeline Update
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 first half of 2025.
Several of Ionis’ medicines (internal as well as partnered) are in phase III development or under regulatory review. Some of these candidates are olezarsen for familial chylomicronemia syndrome (FCS), a rare disease, severe hypertriglyceridemia (sHTG), pelacarsen for cardiovascular disease due to elevated Lp(a) levels, ulefnersen for ALS, with mutations in the fused in sarcoma gene, or FUS (FUS-ALS); donidalorsen for the prophylactic treatment of hereditary angioedema (HAE), bepirovirsen for chronic hepatitis B and zilganersen for Alexander’s disease.
In April 2024, Ionis filed a new drug application (NDA) with the FDA seeking approval for olezarsen in the FCS indication based on results from the phase III BALANCE study. The FDA granted priority review to the NDA, with a decision expected on Dec 19, 2024. If approved, olezarsen will be Ionis’ first medicine that will be launched independently.
Management has completed enrolment in all three late-stage studies evaluating olezarsen in the sHTG indication, which is a much larger patient population. Data from these studies are expected in the second half of 2025.
Some of its other wholly-owned pipeline candidates are ulefnersen and donidalorsen, which are also in late-stage development. While ulefnersen is being developed for FUS-ALS, donidalorsen has been developed for HAE.
In May 2024, Ionis reported top-line results from two phase III studies – OASIS-HAE and OASISplus – which evaluated donidalorsen in HAE patients. Data from these studies showed that treatment with the drug achieved a significant and sustained reduction in the rate of HAE attacks for both monthly and every two-month dosing. Based on these results, Ionis is making preparations to file an NDA for donidalorsen with the FDA in 2024. Additionally, Ionis’ partner, Otsuka, is preparing to submit for marketing approval in Europe before 2024-end.
In the first half of 2024, Ionis reported that a mid-stage study on MASH/NASH candidate ION224 and a phase I/IIa study on Angelman syndrome drug ION582 achieved their respective primary endpoints. A phase III study on ION582 is expected to begin in the first half of 2025.
As regards the partnered candidates, Novartis and GSK GSK are its partners for pelacarsen and bepirovirsen, respectively.
Phase III studies on Ionis and GSK’s bepirovirsen are fully enrolled with data expected to be announced in 2026. Novartis/Ionis plan to report data from pelacarsen studies and file regulatory applications for approval in 2025.
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
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