For the quarter ended June 2024, Ionis Pharmaceuticals (IONS) reported revenue of $225 million, up 19.7% over the same period last year. EPS came in at -$0.45, compared to -$0.60 in the year-ago quarter. The reported revenue represents a surprise of +52.56% over the Zacks Consensus Estimate of $147.49 million. With the consensus EPS estimate being -$0.95, the EPS surprise was +52.63%. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to ...

Ionis Pharmaceuticals (IONS) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.95. This compares to loss of $0.60 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 52.63%. A quarter ago, it was expected that this drug discovery and development company would post a loss of $1.10 per share when it actually produced a loss of $0.98, delivering a surprise of 10.91%. Over the last ...

Core Insights - Ionis Pharmaceuticals is making significant progress with its product launches, including WAINUA for hereditary ATTR polyneuropathy, which is approved in Canada and has a PDUFA date of December 19, 2024, for the U.S. market [1][2] - The company reported a 20% increase in revenue for Q2 2024 compared to the same period last year, driven by R&D revenue growth [5][11] - Ionis is on track to meet its 2024 financial guidance and is preparing for multiple upcoming product launches, including olezarsen and donidalorsen [2][5] Financial Performance - Total revenue for Q2 2024 was $225 million, up from $188 million in Q2 2023, while total revenue for the first half of 2024 reached $345 million, compared to $319 million in the same period last year [6][11] - Operating expenses increased to $291 million in Q2 2024 from $279 million in Q2 2023, reflecting strategic investments in late-stage development and commercialization efforts [5][13] - The company reported a net loss of $66 million for Q2 2024, compared to a net loss of $91 million in Q2 2023 [26] Product Development and Pipeline - WAINUA generated sales of $16 million in Q2 2024, contributing to royalty revenue of $4 million [5][7] - Olezarsen has achieved multiple clinical and regulatory milestones, with a focus on familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG) [7][8] - Donidalorsen is positioned to become the first RNA-targeted prophylactic treatment for hereditary angioedema (HAE), with positive Phase 3 data presented [7][8] Market Position and Strategy - Ionis is focused on advancing its pipeline of innovative medicines, including ION582 for Angelman syndrome, which is set to enter Phase 3 studies in H1 2025 [2][8] - The company is strategically investing in its capabilities to support the upcoming launches of olezarsen and donidalorsen, aiming for sustainable growth [10][14] - Ionis continues to explore collaborations and licensing agreements to enhance its market presence and revenue streams [12][28]

Core Viewpoint - Ionis Pharmaceuticals (IONS) is anticipated to report a year-over-year decline in earnings due to lower revenues, which could significantly influence its near-term stock price depending on how actual results compare to estimates [1][2]. Earnings Expectations - The earnings report is scheduled for August 1, 2024, with expectations of a quarterly loss of $0.99 per share, reflecting a 65% decrease year-over-year [5][6]. - Revenues are projected to be $144.64 million, representing a 23.1% decline from the same quarter last year [6]. Analyst Insights - The Zacks Consensus Estimate has been revised 3.26% higher in the last 30 days, indicating a reassessment of earnings expectations by analysts [6]. - The Most Accurate Estimate for Ionis Pharmaceuticals is higher than the Zacks Consensus Estimate, leading to a positive Earnings ESP of +17.17%, suggesting a likelihood of beating the consensus EPS estimate [14][15]. Historical Performance - In the last reported quarter, Ionis Pharmaceuticals was expected to post a loss of $1.10 per share but actually reported a loss of $0.98, resulting in a surprise of +10.91% [18]. - Over the past four quarters, the company has exceeded consensus EPS estimates three times [19]. Zacks Rank and Predictive Power - The company currently holds a Zacks Rank of 3, indicating a hold position [21]. - A positive Earnings ESP combined with a solid Zacks Rank enhances the predictive power of earnings surprises, with a historical success rate of nearly 70% for stocks with this combination [9].

Loading... Ionis Pharmaceuticals Inc IONS released results Monday from the completed multiple ascending dose (MAD) portion of the Phase 1/2 open-label study of ION582 in people with Angelman syndrome (AS). AS is a rare neurodevelopmental disorder caused by a loss of function in the maternal UBE3A gene. It affects an estimated 1 in 21,000 people worldwide. The data demonstrated consistent and encouraging clinical improvement on assessing all functional domains, including communication, cognition, and motor f ...

Core Insights - Ionis Pharmaceuticals announced positive results from the Phase 1/2 study of ION582 for Angelman syndrome, showing significant clinical improvements in communication, cognition, and motor function [1][2][3] - 97% of patients in the medium and high dose groups experienced improvement in overall Angelman syndrome symptoms as measured by the SAS-CGI-C [1][3] - Ionis plans to initiate Phase 3 development of ION582 in the first half of 2025 [1][2][4] Study Results - The HALOS study included 51 participants aged 2 to 50, demonstrating consistent benefits across all ages and genotypes [3][7] - Improvements in key functional areas exceeded those observed in natural history studies, with significant enhancements noted in the Bayley-4 assessments [3][4] - The study reported favorable safety and tolerability for ION582 at all dose levels [1][3] Assessment Tools - The study utilized various assessment tools, including Bayley-4, Vineland-3, ORCA, and SAS-CGI-C, to evaluate improvements in cognition, communication, and motor function [4][5] - Specific improvements included: - Cognition: 67% improvement on Bayley-4 - Receptive Communication: 67% on Bayley-4, 89% on Vineland-3 - Expressive Communication: 69% on Bayley-4, 84% on Vineland-3 - Gross Motor: 46% on Bayley-4, 53% on Vineland-3 - Fine Motor: 72% on Bayley-4, 63% on Vineland-3 - Daily Living Skills: 74-82% on Vineland-3 [5][6] Future Plans - Ionis intends to meet with regulators to confirm the Phase 3 study design later this year, aiming for a pivotal study initiation in H1 2025 [4][7] - The company is focused on developing transformative medicines for neurological conditions, with ION582 positioned as a cornerstone of its future pipeline [2][10]

Core Insights - Ionis Pharmaceuticals (IONS) has completed full enrollment in a pivotal phase III study for its investigational RNA-targeted therapy, zilganersen, aimed at treating Alexander disease (AxD), a rare neurological condition [11] - The study targets nearly 73 participants aged between 2 to 65 across eight countries [1] - Zilganersen is the first investigational medicine in clinical development specifically for AxD patients, addressing the underlying cause of the disease [6] Group 1: Clinical Development - The pivotal study will randomize participants in a 2:1 ratio to receive zilganersen or placebo over a 60-week double-blind treatment period, followed by a 180-week open-label treatment period [12] - Top-line data from the pivotal study is expected in the second half of 2025 [5] - The primary endpoint of the study is the percent change from baseline in gait speed as assessed by the 10-Meter Walk Test (10MWT) at the end of the 60-week treatment period [19] Group 2: Pipeline and Partnerships - Ionis is preparing to file a New Drug Application (NDA) for donidalorsen with the FDA later this year, which is being evaluated for hereditary angioedema (HAE) [9] - The company has partnerships with major pharmaceutical companies like AstraZeneca, Biogen, and Novartis, which provide funding for internal pipeline development through license fees and milestone payments [14] - Ionis has also developed other treatments, including olezarsen, which is under FDA review for familial chylomicronemia syndrome (FCS), with a decision expected before December 19, 2024 [8][17] Group 3: Market Performance - Year to date, Ionis's stock has decreased by 6.4%, compared to a 4.0% decline in the industry [7] - The company’s strategy includes launching wholly-owned medicines independently, with zilganersen being a key candidate in this approach [13]

CARLSBAD, Calif., July 19, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that it will host a live webcast on Thursday, August 1st at 11:30 a.m. Eastern Time to discuss its second quarter 2024 financial results. About Ionis Pharmaceuticals, Inc. Ionis Pharmaceuticals Investor Contact: D. Wade Walke, Ph.D. – [email protected] – 760-603-2331 SOURCE Ionis Pharmaceuticals, Inc. Webcast scheduled for Thursday, August 1 at 11:30 a.m. Eastern Time The webcast may be accessed at htt ...

Zilganersen is the first investigational medicine in clinical development for people with Alexander disease, a rare, life-threatening neurological condition AxD is estimated to occur in an estimated one in one million people in the U.S. and can present throughout life.1-3 The disease is a result of genetic variants in the glial fibrillary acidic protein (GFAP) gene that disrupt the structure and function of astrocytes in the brain. AxD is generally characterized by cognitive dysfunction and progressive neur ...

CARLSBAD, Calif., July 8, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that it will host a live webcast on Monday, July 22nd at 8:00 a.m. Eastern Time to discuss results from the Phase 1/2a HALOS study of ION582 for the treatment of people with Angelman syndrome. Results from the HALOS study will also be presented on Wednesday, July 24 at the 2024 Angelman Syndrome Foundation (ASF) Family Conference and Research Symposium in Sandusky, Ohio. About Ionis Pharmaceuticals, Inc ...