Ionis Pharmaceuticals (IONS) announced positive results from a phase II study on its investigational drug ION224 in adult patients with metabolic dysfunction-associated steatohepatitis (MASH) over 51 weeks.Study participants who received 90mg and 120mg doses of ION224 achieved the primary endpoint of statistically significant liver histologic improvement. This was measured by at least a two-point reduction in the non-alcoholic fatty liver disease (NAFLD) activity score, or NAS. A subgroup analysis indicated ...

Significant improvement in steatohepatitis with >2 point improvement in NAS score without worsening fibrosis, the primary endpoint of the study Achieved key secondary endpoint of MASH resolution without worsening of fibrosis More ION224 treated patients had an improvement of >1 stage fibrosis compared to placebo ION224 was safe and well-tolerated in this study with once-monthly subcutaneous dosing CARLSBAD, Calif., March 13, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced positiv ...

Kyle Jenne rejoins company to lead commercial strategy Onaiza Cadoret-Manier departing for new career opportunity With broad commercial capabilities in place, Ionis ready to execute on its first independent launches CARLSBAD, Calif., Feb. 29, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that Kyle Jenne has rejoined Ionis as executive vice president, chief global product strategy officer, to lead all aspects of commercialization at the Company. Mr. Jenne has more than 25 ye ...

CARLSBAD, Calif., Feb. 28, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that management will participate in fireside chats at the following investor conferences: TD Cowen 44th Annual Health Care Conference on Tuesday, March 5, 2024 Stifel 2024 Virtual CNS Days on Wednesday, March 20, 2024 A live webcast of these presentations can be accessed on the Investors & Media section of the Ionis website at https://ir.ionispharma.com/events-and-presentations/upcoming-events. Repla ...

Ionis Pharmaceuticals (IONS) reported a loss of 6 cents per share for fourth-quarter 2023, which was significantly narrower than the Zacks Consensus Estimate of a loss of 78 cents per share.The bottom line includes compensation expenses related to equity awards. Excluding these special items, adjusted earnings per share were 12 cents against a loss of $1.18 per share in the year-ago quarter.Total revenues were $325 million in the fourth quarter, which beat the Zacks Consensus Estimate of $184.0 million. Rev ...

Ionis Pharmaceuticals (IONS) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.78. This compares to loss of $0.37 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 92.31%. A quarter ago, it was expected that this drug discovery and development company would post a loss of $1.01 per share when it actually produced a loss of $1.03, delivering a surprise of -1.98%.Over the last fo ...

Exhibit 99.1 Ionis reports fourth quarter and full year 2023 financial results WAINUATM approved with launch underway; on track for EU and Canada approval decisions this year (1) Reconciliation of GAAP to non-GAAP basis contained later in this release. 1 Financial Highlights Recent Marketed Medicines Highlights Positive Phase 3 olezarsen and donidalorsen data, preparing regulatory submissions for FCS and HAE, respectively Olezarsen granted Breakthrough Therapy designation by the FDA for FCS Ionis provides f ...

Financial Performance - Total revenue for 2023 was $787.6 million, a 34% increase from $587.4 million in 2022[470] - Net loss for 2023 was $366.3 million, compared to a net loss of $269.7 million in 2022[470] - Investment income surged to $89.0 million in 2023, up from $25.3 million in 2022, representing an increase of about 251.0%[497] - The company recorded a net loss of $366.3 million for 2023, compared to a net loss of $269.7 million in 2022, indicating an increase in losses of approximately 35.8%[508] Operating Expenses - Total operating expenses for 2023 were $1,141.4 million, up from $997.6 million in 2022, reflecting a 14.4% increase[470] - Operating expenses, excluding non-cash compensation, were $1,035.7 million in 2023, compared to $897.3 million in 2022[478] - SG&A expenses rose to $232.6 million in 2023, compared to $150.3 million in 2022, marking an increase of approximately 54.6%[496] - Medical affairs expenses rose to $22.9 million in 2023, compared to $17.9 million in 2022, reflecting a 27.9% increase[489] - Total drug development expenses for 2023 were $564.8 million, an increase from $457.7 million in 2022[486] - Total R&D support expenses increased to $96.0 million in 2023, up from $73.9 million in 2022, reflecting a rise of about 30.0%[493] - Manufacturing and development chemistry expenses decreased to $74.1 million in 2023 from $86.1 million in 2022, a reduction of approximately 14.5%[491] Revenue Sources - R&D revenue increased to $479.0 million in 2023, up from $284.0 million in 2022, marking a 68.7% increase[472] - WAINUA joint development revenue was $126.4 million in 2023, significantly higher than $76.8 million in 2022[476] - The company recognizes R&D revenue from collaboration agreements, which include technology licenses, R&D services, and manufacturing services[526] Cash and Investments - Cash, cash equivalents, and short-term investments totaled $2,331.2 million as of December 31, 2023, up from $1,986.9 million in 2022[470] - The company raised approximately $575.0 million through the issuance of 1.75% Notes in 2023[503] - The company has raised approximately $2.1 billion from the sale of equity securities since inception[510] Contractual Obligations and Agreements - Total contractual obligations as of December 31, 2023, amounted to $1,587.9 million[513] - The company completed a royalty purchase agreement with Royalty Pharma for $500 million upfront payment in January 2023[517] - The company entered into a royalty purchase agreement with Royalty Pharma in January 2023 to monetize future royalties from SPINRAZA and pelacarsen[532] Tax and Liabilities - Income tax expense increased to $32.3 million in 2023 from $11.7 million in 2022, reflecting an increase of about 175.2%[504] - As of December 31, 2023, a hypothetical 10 percent increase in the liability for preclinical and clinical development costs would result in an increase in loss before income tax benefit of approximately $10.6 million[531] Revenue Recognition Practices - Revenue recognition involves assessing the propriety of revenue recognition and associated deferred revenue, as well as estimating future royalty payments[525] - The company uses an input method to estimate revenue from R&D services with upfront payments, adjusting revenue if estimates change[528] - Milestone payments are recognized based on whether they relate to services performed by the company or its partners, with full recognition for partner-achieved milestones[529] - The company assesses the transaction price for collaboration agreements and allocates it to performance obligations based on relative stand-alone selling prices[526] - Historical accrual estimates for clinical development costs have not materially differed from actual amounts, indicating effective estimation practices[530] Development Pipeline - The company has nine medicines in Phase 3 development and multiple additional medicines in early and mid-stage development[469] Risk Management - The company does not utilize derivative financial instruments to manage exposure to interest rate changes and believes it is not subject to material risks from market changes as of December 31, 2023[534] - Future royalty payments from Novartis for pelacarsen are subject to various factors, including regulatory approval and competing products, which could materially impact estimates[533]

Ionis (IONS) recently announced that the FDA has granted orphan drug designation to its pipeline candidate, olezarsen, for the treatment of familial chylomicronemia syndrome (FCS), a rare genetic disease.The FDA’s orphan drug designation is bestowed on medicines in development for the treatment, prevention or diagnosis of a rare disease that affects fewer than 200,000 people in the United States at the time of designation. The rare disease, FCS, is characterized by extremely high triglyceride levels and rec ...

Analysts on Wall Street project that Ionis Pharmaceuticals (IONS) will announce quarterly loss of $0.78 per share in its forthcoming report, representing a decline of 110.8% year over year. Revenues are projected to reach $183.6 million, increasing 20.8% from the same quarter last year.The consensus EPS estimate for the quarter has been revised 12.6% lower over the last 30 days to the current level. This reflects how the analysts covering the stock have collectively reevaluated their initial estimates durin ...