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AbbVie Seeks FDA Nod for Tavapadon to Treat Parkinson's Disease
ZACKS· 2025-09-29 19:41
Key Takeaways AbbVie has submitted an FDA application for tavapadon to treat Parkinson's disease.TEMPO studies showed tavapadon improved symptoms across a broad Parkinson's disease population.If approved, tavapadon would be AbbVie's second recent Parkinson's therapy clearance.AbbVie (ABBV) announced that it has submitted a regulatory filing with the FDA, which seeks approval for its investigational drug tavapadon as a once-daily oral treatment for Parkinson’s disease (PD).The FDA filing is supported by resu ...
Will AbbVie's Neuroscience Portfolio Continue to Aid Top-line Growth?
ZACKS· 2025-09-04 14:21
Core Insights - AbbVie has developed a strong neuroscience franchise, initially driven by blockbuster drugs like Botox Therapeutic and Vraylar, and has expanded its portfolio with new migraine treatments Qulipta and Ubrelvy, as well as Vyalev for Parkinson's disease [1][2]. Financial Performance - The neuroscience segment contributed over 17% to AbbVie's total sales in the first half of 2025, with revenues growing nearly 21% year over year, primarily due to increased sales of Botox Therapeutic and Vraylar, along with rising uptake of Ubrelvy and Qulipta [2][9]. - The strong performance in the neuroscience segment has helped mitigate the decline in Duodopa sales [2][9]. Product Launches and Acquisitions - AbbVie launched Vyalev in the U.S. earlier this year, and while initial sales have been modest, expectations are for its contribution to total revenues to grow over time [3]. - The company is actively investing in new therapies, including a recent agreement to acquire Gilgamesh Pharmaceuticals' lead pipeline drug for approximately $1.2 billion, which targets major depressive disorder (MDD). This follows a $1.4 billion acquisition of Aliada Therapeutics, which added an investigational antibody for Alzheimer's disease (AD) [4][5]. Competitive Landscape - Major competitors in the neuroscience space include Biogen and Johnson & Johnson. Biogen is diversifying its offerings due to declining revenues in its multiple sclerosis franchise and has partnered with Eisai to market an FDA-approved treatment for Alzheimer's disease [6]. - Johnson & Johnson has a strong neuroscience portfolio, including the antidepressant nasal spray Spravato and the antipsychotic Invega Sustenna, and recently acquired Intra-Cellular Therapies to enhance its offerings [7]. Valuation and Market Performance - AbbVie shares have outperformed the industry year to date, trading at a premium with a price/earnings (P/E) ratio of 15.59, compared to the industry average of 14.84 and above its five-year mean of 12.82 [8][11]. - Earnings per share (EPS) estimates for 2025 and 2026 have seen slight increases in the past 30 days [12].
AbbVie Beats on Q2 Earnings & Sales, Stock Up on Raised '25 EPS View
ZACKS· 2025-07-31 17:16
Financial Performance - AbbVie Inc. reported second-quarter 2025 adjusted EPS of $2.97, exceeding the Zacks Consensus Estimate of $2.89 and the company's guidance of $2.84-$2.88, with earnings rising 12.1% year over year [1] - Revenues for the quarter reached $15.42 billion, surpassing the Zacks Consensus Estimate of $15.07 billion, with a year-over-year increase of 6.6% on a reported basis and 6.5% on an operational basis [2] Key Drug Performance - Sales of Rinvoq totaled $2.03 billion, up 41.2%, driven by market share gains and recent label expansion [4] - Skyrizi generated $4.42 billion in sales, reflecting a 61.8% increase, attributed to strong volume growth and market share gains [5] - Humira experienced a significant sales decline of 58.2% to $1.18 billion, with U.S. sales down 66% to $802 million due to loss of exclusivity [6][7] - Neuroscience portfolio sales increased 24% to $2.68 billion, driven by higher sales of Botox Therapeutic, Vraylar, Ubrelvy, and Qulipta [8] Oncology and Other Drug Sales - Oncology franchise sales rose 2.4% to $1.68 billion, supported by newer drugs like Epkinly and Elahere, despite a decline in Imbruvica sales [10][11] - Venclexta generated revenues of $691 million, reflecting 8.3% growth, while Elahere sales rose 23.7% to $159 million, although it missed expectations [13] Cost and Guidance - Adjusted SG&A expenses decreased 2.3% year over year to $3.24 billion, while adjusted R&D expenses increased 10.3% to $2.12 billion [16] - AbbVie raised its full-year 2025 EPS guidance to a range of $11.88-$12.08, up from the previous range of $11.67-$11.87 [17] Market Reaction and Strategic Moves - AbbVie shares rose over 5% in pre-market trading following the upward revision in guidance, with a year-to-date stock gain of about 7% compared to the industry's 4% decline [20] - The company continues to invest in its future pipeline through strategic collaborations, including a licensing deal for an investigational trispecific antibody and interest in acquiring Gilgamesh Pharmaceuticals [22]
Pre-Q2 Earnings: Is AbbVie Stock a Portfolio Must-Have?
ZACKS· 2025-07-28 16:21
Core Viewpoint - AbbVie is expected to report second-quarter 2025 earnings on July 31, with sales estimated at $15.07 billion and earnings per share (EPS) at $2.89, although earnings estimates have declined recently [1][4][5] Financial Performance - AbbVie has consistently exceeded earnings expectations in the past four quarters, with an average earnings surprise of 2.93% [2][3] - The company anticipates adjusted earnings between $2.84 and $2.88 per share for Q2 2025, with net revenues around $15.0 billion [5] Product Performance - Growth is expected to be driven by newer immunology drugs, Skyrizi and Rinvoq, with sales estimates of $4.12 billion and $1.98 billion respectively [6] - Humira, which lost patent protection in January 2023, is projected to generate $1.41 billion in sales, reflecting ongoing sales erosion [7] - Sales for Imbruvica are expected to decline due to competition, with estimates at $704 million [8] - Venclexta sales are likely to rise, estimated at $668 million, driven by strong demand [9] - Neuroscience product sales are projected at $2.47 billion, supported by strong growth in drugs like Botox and Vraylar [10][11] Market Position and Valuation - AbbVie shares have outperformed the industry this year, trading at a price/earnings ratio of 14.44, slightly below the industry average of 15.34 [13][16] - Despite challenges from Humira biosimilars, AbbVie expects robust revenue growth in 2025, with a projected high single-digit revenue CAGR through 2029 [18] Strategic Outlook - AbbVie is investing in its future pipeline through collaborations, including a recent licensing deal for an investigational antibody targeting oncology and autoimmune diseases [20] - The company’s diverse portfolio, including drugs like Venclexta, Vraylar, and others, is expected to offset losses from declining sales in certain areas [19]
How Will AbbVie's Neuroscience Franchise Perform in Q2 Earnings?
ZACKS· 2025-07-22 14:35
Core Insights - AbbVie holds a leadership position in the neuroscience space, with significant products including Botox Therapeutic and Vraylar, contributing to over 17% of the company's first-quarter revenues, which grew 16% year over year [1][10]. Neuroscience Franchise Performance - The neuroscience franchise is estimated to generate $2.5 billion in sales for Q2 2025, reflecting a 15% year-over-year growth, driven by higher sales of Botox Therapeutic and Vraylar, along with market share gains for Ubrelvy and Qulipta [2][10]. - Newly launched Vyalev is expected to contribute modest sales in the U.S., with the majority of its revenue coming from international markets [3][10]. Competitive Landscape - Major competitors in the neuroscience space include Biogen and Johnson & Johnson [5]. - Biogen generates over half of its revenue from neuroscience therapies and markets FDA-approved treatments for Alzheimer's disease and postpartum depression [6]. - Johnson & Johnson's neuroscience portfolio includes leading products like Spravato and Invega Sustenna, with recent acquisitions enhancing its offerings [8]. Valuation and Market Performance - AbbVie shares have outperformed the industry year to date, trading at a price/earnings (P/E) ratio of 14.06, slightly below the industry average of 14.60 [9][12]. - EPS estimates for 2025 have decreased from $12.32 to $11.98, while estimates for 2026 have increased from $14.06 to $14.08 over the past month [13].
AbbVie Beats on Q1 Earnings & Sales, Raises '25 EPS View
ZACKS· 2025-04-25 18:20
Core Viewpoint - AbbVie Inc. reported strong first-quarter 2025 results, with adjusted EPS and revenues exceeding estimates, driven by robust sales of key immunology drugs and newer products, despite a significant decline in Humira sales [1][2][18]. Financial Performance - Adjusted EPS for Q1 2025 was $2.46, beating the Zacks Consensus Estimate of $2.39 and the company's guidance of $2.34-$2.38, reflecting a 6.5% year-over-year increase [1]. - Revenues reached $13.34 billion, surpassing the Zacks Consensus Estimate of $12.91 billion and the company's forecast of $12.8 billion, with an 8.4% year-over-year increase on a reported basis and 9.8% on an operational basis [2]. Drug Performance - Immunology drugs drove revenue growth, with Rinvoq generating $1.72 billion (up 59.7%) and Skyrizi at $3.43 billion (up 72%), both exceeding estimates and company guidance [4][5]. - Humira sales declined 49.5% to $1.12 billion, with U.S. sales down 58% to $744 million, missing estimates due to loss of exclusivity [6][7]. - Neuroscience portfolio sales increased 17% to $2.28 billion, driven by Botox Therapeutic and migraine drugs, surpassing estimates [8]. - Oncology/hematology sales rose 7.5% to $1.63 billion, supported by Elahere and Venclexta, exceeding estimates [10]. Cost and Guidance - Adjusted SG&A expenses rose 8.2% to $3.28 billion, while adjusted R&D expenses increased 13.3% to $2.05 billion [16]. - AbbVie raised its full-year EPS guidance to $12.09-$12.29, up from $11.99-$12.19, reflecting stronger-than-expected sales from newer drugs [17]. Market Reaction - AbbVie shares rose over 5% in pre-market trading following the positive earnings report and guidance update, with a year-to-date gain of about 2% compared to the industry's 1% decline [19].
Buy, Sell or Hold ABBV Stock? Key Tips Ahead of Q1 Earnings
ZACKS· 2025-04-23 13:35
Core Viewpoint - AbbVie is expected to report first-quarter 2025 earnings on April 25, with sales estimated at $12.91 billion and earnings at $2.40 per share, although earnings estimates have declined recently [1][6]. Financial Performance - AbbVie has a history of exceeding earnings expectations, with a trailing four-quarter average earnings surprise of 2.37% and a recent surprise of 1.41% [1]. - The company anticipates adjusted earnings between $2.34 and $2.38 per share and net revenues of approximately $12.8 billion for the upcoming quarter [6]. Revenue Drivers - Sales growth is expected to be driven by newer immunology drugs, Skyrizi and Rinvoq, with consensus estimates for their sales at $3.19 billion and $1.61 billion, respectively [7]. - The immunology franchise is projected to generate $6.1 billion in revenues, including $3.2 billion from Skyrizi, $1.6 billion from Rinvoq, and $900 million from U.S. Humira [9]. Challenges - AbbVie has faced sales erosion following the loss of patent protection for Humira, with consensus estimates for its sales at $1.32 billion [8]. - The oncology segment is expected to generate $1.5 billion, with Imbruvica sales declining due to competition, estimated at $676 million [10]. Neuroscience and Aesthetics Segments - Neuroscience sales are projected at $2.1 billion, driven by products like Botox Therapeutic and Vraylar, with consensus estimates at $2.16 billion [13]. - Aesthetics sales are expected to be impacted by sluggish growth in Botox and Juvederm, with estimates at $1.14 billion [14]. Stock Performance and Valuation - AbbVie shares have declined 2% year-to-date, outperforming the industry and S&P 500 [16]. - The stock trades at a price/earnings ratio of 13.58, slightly below the industry average of 14.89, but above its five-year mean of 12.06 [19]. Long-term Outlook - AbbVie is well-positioned for growth despite challenges, with strong sales from Skyrizi and Rinvoq, and a proactive approach to pipeline development [21][22]. - The company has entered the obesity treatment market, indicating strategic expansion [23]. - Despite some declining estimates, the solid pipeline and growth prospects for 2025 sales and profits suggest a reason to remain invested in AbbVie stock [24].
Here's How to Play AbbVie Stock as it Enters the Obesity Space
ZACKS· 2025-03-05 14:40
Core Viewpoint - AbbVie is expanding its presence in the obesity treatment market by in-licensing GUB014295, a long-acting amylin analog, from Gubra, with a total potential deal value of $2.225 billion [1][2][3] Industry Overview - The obesity market is projected to reach $100 billion by 2030, with current dominance by GLP-1 drugs from Eli Lilly and Novo Nordisk [3] - Major pharmaceutical companies, including Merck, Pfizer, Amgen, and AstraZeneca, are actively pursuing opportunities in the obesity space through in-house development or licensing deals [3] AbbVie's Product Performance - AbbVie has successfully launched Skyrizi and Rinvoq, generating combined sales of $17.7 billion in 2024, particularly excelling in the inflammatory bowel disease market [5][6] - The company anticipates combined sales of Skyrizi and Rinvoq to exceed $31 billion by 2027, driven by market growth and new indications [7] Pipeline and Acquisitions - AbbVie has a robust pipeline with several early/mid-stage candidates and expects multiple regulatory submissions and approvals in the next 12 months [8][9] - The company has been active in acquisitions, signing over 20 early-stage deals in 2024 to enhance its pipeline in immunology, oncology, and neuroscience [11][12] Sales Trends and Challenges - AbbVie is experiencing declining sales from Humira due to biosimilar competition, with a sharper decline expected in 2025 [13] - The aesthetics portfolio, including Juvederm fillers, has also seen a decline, with a 14.6% drop in sales in 2024 [14][15] Stock Performance and Valuation - AbbVie stock has outperformed the industry with a 14.8% increase over the past year [16][18] - The stock trades at a price/earnings ratio of 16.52, slightly below the industry average of 17.80, but higher than many large drugmakers [19][20] Earnings Estimates - The Zacks Consensus Estimate for AbbVie's 2025 earnings has increased from $12.24 to $12.29 per share, indicating positive sentiment [22]