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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 ...
3 Unstoppable Dividend Stocks to Buy If There's a Stock Market Sell-Off
The Motley Fool· 2025-09-19 08:44
Market Overview - The stock market is currently experiencing high valuations, with major indexes at or near all-time highs, following recent interest rate cuts by the Federal Reserve [2] - Despite the positive outlook, there is a possibility of a significant market correction by early 2026 due to elevated economic uncertainty [2] Company Analysis: AbbVie - AbbVie has a high price-to-earnings ratio of 103, but its forward earnings multiple is around 15, indicating potential growth [5] - The company is seeing strong sales from its autoimmune disease drugs Skyrizi and Rinvoq, as well as migraine therapies Qulipta and Ubrelvy, with a robust pipeline of around 50 programs in mid- or late-stage clinical development [6] - AbbVie is a Dividend King, having increased its dividend for over 50 consecutive years, with a current yield of nearly 3% [8] Company Analysis: Enterprise Products Partners - Enterprise Products Partners has demonstrated strong cash flow resilience through various economic downturns, including the financial crisis and the COVID-19 pandemic [9] - The company operates over 50,000 miles of pipeline, providing critical energy infrastructure that is largely recession-resistant, with 90% of long-term contracts including inflation escalation provisions [10] - The company has a distribution yield of 6.8% and has increased its distribution for 27 consecutive years [11] Company Analysis: Pfizer - Pfizer offers a high dividend yield of 7.15% and is committed to maintaining and growing its dividend [12] - The stock trades at a low valuation of 7.7 times forward earnings, with a PEG ratio of 0.96, suggesting it may not decline significantly even in a market correction [13] - Pfizer has a strong product lineup and a robust pipeline with 108 candidates, including 28 in late-stage testing, which should help offset anticipated sales declines from patent expirations [14]
Is ABBV Stock a Buy, Hold, or Sell After Its Almost 23% Rise YTD?
ZACKS· 2025-09-16 15:56
Core Insights - AbbVie (ABBV) has seen a stock increase of 22.5% in 2025, outperforming the industry, sector, and S&P 500 index, which has seen a decrease of 0.1% [1][3][8] Company Performance - The strong stock performance is attributed to rising investor optimism as AbbVie successfully navigated the loss of exclusivity for its blockbuster drug, Humira, which previously accounted for over 50% of total revenues [4][5] - AbbVie launched two successful immunology drugs, Skyrizi and Rinvoq, which are performing well and expected to support top-line growth in the coming years [5][8] - Combined sales of Skyrizi and Rinvoq reached $11.6 billion in the first half of 2025, with projections of over $25 billion in 2025 and more than $31 billion by 2027 [7][8] Drug Performance - Skyrizi is annualizing at almost $18 billion, while Rinvoq is at over $8 billion, with both drugs showing strong performance in the inflammatory bowel disease market [8][9] - AbbVie expects to file for new indications for Rinvoq, which could add approximately $2 billion to peak-year sales [10][11] Oncology and Neuroscience Contributions - AbbVie's oncology segment generated $3.3 billion in the first half of 2025, driven by higher sales of Venclexta and contributions from new drugs [12] - Sales in the neuroscience portfolio increased by 20.3% to nearly $5 billion, supported by products like Botox Therapeutic and newer migraine treatments [13] Acquisition Strategy - AbbVie has executed over 30 M&A transactions since early 2024, focusing on immunology, oncology, and neuroscience to strengthen its pipeline [14] - Recent acquisitions include a licensing agreement for a treatment for obesity and a deal for a novel therapy for major depressive disorder [14][15] Challenges - Humira's sales are declining significantly due to biosimilar competition, with a more than 50% drop in the first half of 2025 [16] - Sales of Juvederm fillers have also decreased by 22.2% due to macroeconomic challenges and weakened consumer sentiment [17] Valuation and Estimates - AbbVie shares trade at a price/earnings ratio of 15.93, higher than the industry average of 14.78, indicating a relatively high valuation [18][19] - The Zacks Consensus Estimate for 2025 earnings has slightly decreased from $12.08 to $12.02, while the estimate for 2026 has increased from $14.07 to $14.33 [22] Future Outlook - AbbVie is expected to return to mid-single-digit revenue growth in 2025, driven by the performance of Skyrizi and Rinvoq, with no significant loss of exclusivity events anticipated for the rest of the decade [25][26] - The company is well-positioned for continued growth, supported by a solid pipeline and recent patent settlements [26][27]
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].
ABBV Buys Rights to Bretisilocin, a Novel Psychedelic for Depression
ZACKS· 2025-08-26 13:10
Core Insights - AbbVie has announced a deal to acquire Gilgamesh Pharmaceuticals' lead pipeline candidate, bretisilocin, which is being developed for treating major depressive disorder (MDD) [1][8] Group 1: Deal Details - AbbVie will pay up to $1.2 billion for the acquisition, which includes an upfront payment and development milestones [6][8] - Gilgamesh will spin off its other drug programs into a new company, Gilgamesh Pharma, while AbbVie retains full control of bretisilocin [6][7] Group 2: Clinical Data - Bretisilocin is currently in a phase II study for moderate-to-severe MDD, showing rapid and durable antidepressant effects [2][8] - In the phase II study, bretisilocin led to a statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, with patients improving by an average of 21.6 points compared to 12.1 points for the comparator at Day 14 [2] Group 3: Market Context - AbbVie has been actively acquiring companies to strengthen its early-stage neuroscience pipeline, with recent deals including the acquisition of Aliada and Cerevel Therapeutics [9][10] - AbbVie's neuroscience portfolio has seen significant growth, with sales increasing by 20.3% to around $5 billion in the first half of 2025, driven by products like Botox Therapeutic and Vraylar [11]
AbbVie Rises 11.5% in a Month: Buy, Hold or Sell the Stock?
ZACKS· 2025-08-20 14:42
Core Insights - AbbVie's stock has increased by 11.5% in the past month due to strong second-quarter performance, beating earnings and sales estimates with earnings of $2.97 per share, a 12.1% year-over-year increase [1][2] Financial Performance - Revenues reached $15.42 billion, reflecting a 6.6% year-over-year increase, driven by strong sales of key drugs such as Rinvoq and Skyrizi, alongside contributions from newer drugs like Ubrelvy and Elahere [2][3] - AbbVie raised its revenue and EPS guidance for 2025, expecting adjusted EPS between $11.88-$12.08 and total revenues around $60.5 billion, up from previous estimates [3] Product Performance - AbbVie has successfully launched new immunology drugs, Skyrizi and Rinvoq, which are expected to replace declining sales from Humira, generating combined sales of $11.6 billion in the first half of 2025 [5][7] - Skyrizi and Rinvoq are projected to achieve combined sales exceeding $25 billion in 2025 and over $31 billion by 2027, with Skyrizi annualizing at nearly $18 billion and Rinvoq at over $8 billion [8][9] Oncology and Neuroscience Growth - The oncology segment generated $3.3 billion in the first half of 2025, a 4.2% year-over-year increase, supported by new drug launches and the addition of antibody-drug conjugates [11][13] - Sales in the neuroscience portfolio increased by 20.3% to nearly $5 billion, driven by products like Botox Therapeutic and newer migraine treatments [14] Acquisition Strategy - AbbVie has engaged in over 30 M&A transactions since early 2024, focusing on immunology, oncology, and neuroscience to enhance its early-stage pipeline [15][16] - Recent acquisitions include Capstan Therapeutics, adding a potential first-in-class CAR-T therapy to its immunology pipeline [16] Challenges and Market Dynamics - Humira's sales have declined over 50% in the first half of 2025 due to biosimilar erosion, with expectations of continued decline as more plans adopt exclusionary formularies [17] - Sales of Juvederm fillers have also decreased by 22.2% in the first half of 2025, impacted by macroeconomic challenges and weakened consumer sentiment [18] Stock Performance and Valuation - AbbVie's stock has gained 19.3% year-to-date, outperforming the industry and S&P 500 [19] - The stock trades at a price/earnings ratio of 15.31, higher than the industry average of 14.46, indicating a relatively high valuation compared to some peers [22] Future Outlook - AbbVie anticipates returning to mid-single-digit revenue growth in 2025, driven by the performance of Skyrizi and Rinvoq, with no significant loss of exclusivity events expected for the remainder of the decade [28][29]
AbbVie Raises 2025 Outlook After Q2 Beat
The Motley Fool· 2025-08-04 15:23
Core Insights - AbbVie reported strong second quarter 2025 results with adjusted EPS of $2.97 and net revenues of $15.4 billion, exceeding expectations [1] - The company raised its full-year revenue guidance by $800 million to $60.5 billion, driven by growth in immunology and neuroscience portfolios [1][12] Immunology Performance - SKYRIZI generated global revenue of $4.4 billion, up 61.8% year-over-year, while RINVOQ reached $2 billion, up 41.2%, benefiting from strong market share gains [3] - Combined sales of SKYRIZI and RINVOQ are projected to exceed $25 billion for the year, with SKYRIZI leading in the psoriasis market and RINVOQ expanding in IBD and rheumatology [4][5] R&D Pipeline and Growth Strategy - AbbVie has executed over 30 business development transactions since early 2024, including entering the obesity market and acquiring innovative CAR-T and immunology assets [6] - Recent FDA approvals and positive phase 3 data for RINVOQ position the company for sustained growth as it shifts focus from legacy biologics [7] Neuroscience Growth - The neuroscience portfolio achieved $2.7 billion in revenue, up 24% year-over-year, with significant contributions from Vraylar, Botox Therapeutic, Ubrelvy, and QULIPTA [8] - QULIPTA demonstrated superiority in migraine prevention, contributing to a $100 million upward revision in full-year guidance [9][10] Future Outlook - Management set net revenue guidance at approximately $15.5 billion for the next quarter, with adjusted EPS expected between $3.24 and $3.28 [12] - Updated product-level guidance includes SKYRIZI revenues of $17.1 billion and neuroscience sales of $10.5 billion for the full year [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]
Will These 5 Pharma/Biotech Bigwigs Surpass Q2 Earnings Forecasts?
ZACKS· 2025-07-28 15:31
Industry Overview - The second-quarter 2025 reporting cycle for the Medical sector is commencing, with most firms expected to release earnings results in the next two weeks, primarily consisting of pharma/biotech and medical device companies [1] - The earnings season for the drug and biotech sector began in mid-July, highlighted by Johnson & Johnson's strong performance, which exceeded earnings and sales estimates, leading to raised revenue and earnings expectations for the year [1] Company Performance - Novartis surpassed second-quarter earnings and revenue estimates, driven by a year-over-year increase in sales of key drugs, prompting an upward revision of its annual guidance for core operating income [2] - Roche experienced solid growth in the first half of 2025, with high demand for key drugs offsetting declines in legacy drug sales [2] - As of July 23, 15% of companies in the Medical sector, representing 27.2% of the sector's market capitalization, reported quarterly earnings, with 88.9% outperforming earnings estimates and 100% beating revenue estimates [3] - Overall, second-quarter earnings for the Medical sector are projected to increase by 0.9%, while sales are expected to rise by 7.9% compared to the previous year [3] Upcoming Earnings Reports - Merck, AstraZeneca, Bristol Myers, AbbVie, and Moderna are scheduled to release their quarterly results this week [4] - Merck has a strong earnings track record, beating estimates in the last four quarters with an average surprise of 3.82% [5] - AstraZeneca has a mixed earnings history, beating estimates in three of the last four quarters, with an average surprise of 4.24% [8] - Bristol Myers has consistently beaten earnings estimates, with an average surprise of 20.16% over the last four quarters [11] - AbbVie has also maintained a strong track record, beating estimates in the last four quarters with an average surprise of 2.55% [13] - Moderna has an excellent earnings history, with an average surprise of 31.60% in the last four quarters [15] Sales Drivers - Merck's growth in the second quarter is likely attributed to increased sales of its cancer drug Keytruda, driven by additional indications and patient demand [7] - AstraZeneca's sales are expected to be bolstered by strong demand for its cancer and diabetes medications [10] - Bristol Myers' revenue may be impacted by declines in legacy drug sales, but growth products are expected to partially offset this decline [12] - AbbVie's revenue is anticipated to be driven by strong sales of key drugs and contributions from newer products [14] - Moderna's revenues are expected to be influenced by sales of its COVID-19 vaccine, Spikevax, while the focus is shifting to updates on its broader pipeline [16]