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FDA Approves NVS' Cosentyx in Hidradenitis Suppurativa for Adolescents
ZACKS· 2026-03-16 14:42
Core Insights - Novartis received FDA approval for a label expansion of its psoriasis drug Cosentyx, now indicated for pediatric patients aged 12 and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor available for this demographic [1][7] - Cosentyx generated sales of $6.7 billion in 2025, reflecting an 8% increase from 2024, driven by demand from recent launches and growth in core indications [5][7] - The approval for pediatric use is supported by adult HS studies and pharmacokinetic modeling, indicating comparable drug exposure between pediatric and adult patients [3][4] Product and Market Performance - Cosentyx is already approved for multiple conditions, including HS, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, marking its fourth pediatric indication [4][7] - The drug's sales growth is attributed to continued demand from recent launches, including the HS indication and an intravenous formulation in the U.S. [5][7] - However, Cosentyx is set to lose exclusivity in the U.S. in 2029, which may impact future sales [8] Strategic Developments - Novartis is focusing on key growth drivers such as Kisqali, Kesimpta, Pluvicto, and Scemblix to support overall revenue growth [10] - The company recently acquired Avidity Biosciences, enhancing its neuromuscular pipeline and potentially unlocking multi-billion-dollar market opportunities with product launches targeted before 2030 [11][12] - Novartis projects a net sales compound annual growth rate (CAGR) of 5-6% at constant currency from 2025 to 2030, bolstered by advancements in its late-stage pipeline [12]
Merck vs. Bristol Myers: Which Pharma Stock Is a Better Pick in 2026?
ZACKS· 2026-02-20 18:06
Core Insights - Merck & Co. (MRK) and Bristol Myers Squibb (BMY) are significant players in the pharmaceutical industry with diverse product portfolios [1][2] - Merck is recognized for its leadership in oncology, while Bristol Myers focuses on breakthrough therapies across multiple therapeutic areas [1][2] Merck (MRK) Overview - Merck has over six blockbuster drugs, with Keytruda accounting for 54% of total sales in 2025, driving revenue growth [3][4] - Keytruda's sales increased by approximately 7% in 2025, benefiting from its approval for various oncology indications [4] - The FDA approved Keytruda Qlex for subcutaneous administration in September 2025, with peak sales targeted at $35 billion by 2028 [5] - Other oncology drugs like Welireg, Lynparza, and Lenvima are contributing to growth, alongside a strong launch of Winrevair in pulmonary arterial hypertension [6] - Merck is enhancing its vaccine portfolio, particularly with the new 21-valent pneumococcal conjugate vaccine, Capvaxive [7] - The company has around 80 ongoing late-stage studies, expecting over $70 billion in potential commercial opportunities by the mid-2030s [8] Bristol Myers Squibb (BMY) Overview - BMY's growth portfolio includes key brands such as Opdivo, Yervoy, and Reblozyl, with a strong oncology focus [12] - Opdivo's consistent label expansion has maintained its momentum, and the approval of Opdivo Qvantig has strengthened its franchise [13] - BMY's Reblozyl sales exceed $2 billion annually, and strong performance in cardiovascular drug Camzyos has boosted revenues [14] - However, legacy drugs face significant generic competition, with expected sales declines of 12-16% in 2026 [15] - BMY is pursuing strategic acquisitions and collaborations, including a recent agreement with BioNTech to co-develop a bispecific antibody [16][17] - The company aims for $2 billion in annualized cost savings by the end of 2027, having achieved approximately $1 billion in savings in 2025 [18] Financial Performance and Valuation - MRK's 2026 sales are estimated to increase by 2.59%, but EPS is expected to decline by 38.75% [20] - BMY's 2026 sales are projected to decrease by 2.32%, while EPS is expected to increase by 0.33% [20] - MRK shares trade at 21X forward earnings, while BMY trades at 9.74X, with the industry average at 18.74X [24] - BMY offers a higher dividend yield of 4.22% compared to MRK's 2.79% [25] Investment Outlook - BMY is currently viewed as a stronger near-term investment option compared to MRK, which faces multiple headwinds [9][30] - BMY's strategic initiatives and new drug approvals position it favorably against MRK's challenges, including declining sales of Gardasil and competitive pressures on Keytruda [27][30]
NVS Reports Positive Late-Stage Data on Kidney Disease Drug Vanrafia
ZACKS· 2026-02-13 16:20
Core Insights - Novartis (NVS) announced positive results from the late-stage III ALIGN study for its kidney disease drug Vanrafia (atrasentan) [1][9] - The ALIGN study demonstrated that Vanrafia effectively slows the decline of kidney function in patients with IgA nephropathy [3][4] Study Results - Vanrafia showed a significant difference in estimated glomerular filtration rate (eGFR) change from baseline compared to placebo, with a 2.39 ml/min/1.73m² difference at week 136 and a 2.59 ml/min/1.73m² difference at week 132 [3][4] - The study included a subgroup of patients receiving SGLT2 inhibitors, who also exhibited similar benefits [4] Regulatory Status - Vanrafia received accelerated approval in the United States and China in 2025 for reducing proteinuria in adults with IgA nephropathy, with plans for traditional approval in 2026 [5][9] Product Portfolio - Novartis' renal portfolio includes Fabhalta (iptacopan), which is approved for treating adults with paroxysmal nocturnal hemoglobinuria and has also received accelerated approval for IgA nephropathy [6] - Fabhalta generated sales of $155 million in Q4 and $505 million in 2025 [7] Market Context - 2026 is a critical year for Novartis due to the patent expiry of its cardiovascular drug Entresto, which is the largest in its history [8] - Novartis shares have increased by 52.9% over the past year, outperforming the industry growth of 20.6% [8]
Will BMY's Legacy Portfolio Decline Weigh on Its 2026 Top Line?
ZACKS· 2026-02-10 17:10
Core Insights - Bristol Myers' legacy portfolio is experiencing significant revenue decline due to generic competition, with a 15% year-over-year drop in Q4 revenues to $5.1 billion [1][9] - For the full year 2025, legacy portfolio revenues fell 15% to $21.8 billion, accounting for 45% of total revenues of $48.2 billion, with further expected decline of 12-16% in 2026 [2][9] - Eliquis, a key product in the legacy portfolio, saw sales growth of 8% in 2025, totaling $14.4 billion, and is projected to grow 10-15% in 2026 despite pricing changes [3][4][9] Legacy Portfolio Performance - The legacy portfolio includes Eliquis, Revlimid, Pomalyst, Sprycel, and Abraxane, with significant erosion from generics impacting revenues [1] - Eliquis continues to benefit from strong global demand, but overall growth is hindered by generic pressures and increased government-channel rebates in the U.S. [3] - The company anticipates a decline in Eliquis sales in 2027, projecting a decrease of $1.5-$2 billion [4] Competitive Landscape - Bristol Myers faces increasing competition in oncology from major pharmaceutical companies like Merck and Pfizer, which are advancing their own therapies [5][9] - Merck's Keytruda dominates the immuno-oncology space, accounting for around 50% of its pharmaceutical sales, while the company is developing bispecific antibodies for long-term growth [6] - Pfizer has a diverse oncology portfolio, including antibody-drug conjugates and biosimilars, targeting various cancer types [8] Financial Performance and Valuation - Bristol Myers' shares have increased by 32.3% over the past six months, outperforming the industry growth of 26.7% [11] - The company is trading at a price/earnings ratio of 9.96x forward earnings, which is lower than the large-cap pharma industry's average of 18.76x [12] - The Zacks Consensus Estimate for 2026 EPS has risen to $6.13, while the estimate for 2027 has increased to $5.92 [13]
Novartis Faces Biggest Patent Expiry Ever but Sees Growth Ahead
Benzinga· 2026-02-04 17:25
Core Insights - Novartis AG reported fourth-quarter 2025 net sales of $13.34 billion, a 1% year-over-year increase, but below Wall Street's estimate of $13.78 billion [1] - On a constant-currency basis, sales decreased by 1% [1] - The company faced a significant negative impact from generic competition, which reduced sales by 15 percentage points, including a 3 percentage point impact from revenue deduction adjustments in the U.S. related to Entresto and Promacta [1] Financial Performance - Pricing pressures negatively impacted sales by 4 percentage points, while currency fluctuations had a positive impact of 2 percentage points [2] - Core operating income increased by 1% to $4.93 billion, with a core operating income margin of 37.0%, reflecting a slight increase of 0.1 percentage points [2] - The growth in core operating income was supported by higher government grant income and lower selling, general, and administrative (SG&A) expenses, although this was partially offset by increased research and development (R&D) expenses [2] Product Performance - Strong demand for key therapies contributed to growth, with Kisqali sales rising 44% to $1.32 billion, Kesimpta increasing 27% to $1.23 billion, and Cosentyx revenue up 11% to $1.81 billion [3] - Scemblix saw an 87% increase to $391 million, while Pluvicto advanced 70% to $605 million [3] Future Outlook - For fiscal 2026, Novartis anticipates low single-digit growth in net sales, while core operating income is expected to decrease in the low single digits [5] - The incoming CFO indicated that adjusted operating income is projected to grow significantly in the second half of 2026, which is expected to positively impact 2027 and beyond [5] - Novartis shares rose 1.79% to $152.54, reaching a new 52-week high [5]
Novartis Beats on Q4 Earnings, Entresto Generics Pressure Sales
ZACKS· 2026-02-04 15:36
Core Insights - Novartis AG reported fourth-quarter core earnings per share of $2.03, exceeding the Zacks Consensus Estimate of $1.99 and up from $1.98 a year ago [1][7] - Core net income decreased by 1% to $3.9 billion, while revenues of $13.3 billion fell short of the Zacks Consensus Estimate of $13.7 billion, despite a 1% year-over-year increase [2][7] - The company faced revenue pressure from generic competition for key drugs Entresto and Promacta, leading to a 1% decline in sales on a constant currency basis [2][26] Financial Performance - Core operating income improved by 1% to $4.9 billion, supported by higher government grant income and lower SG&A expenses, although offset by increased R&D expenses [19] - For 2025, Novartis reported sales growth of 8% to $54.53 billion, surpassing the Zacks Consensus Estimate, with core EPS increasing by 17% to $8.98 [20] - Guidance for 2026 indicates low single-digit growth in net sales on a constant currency basis, with core operating income expected to decline in low single digits [21] Drug Performance - Cosentyx sales rose 11% to $1.8 billion, driven by strong demand across all regions [5] - Kisqali sales surged 44% to $1.32 billion, although it missed estimates, with underlying global growth at 54% [6][8] - Entresto sales plummeted 45% to $1.2 billion due to generic competition, while Promacta sales fell 63% to $226 million [8][13] - Pluvicto sales increased by 70% to $605 million, driven by strong demand following recent approvals [11] - Kesimpta sales grew 27% to $1.2 billion, while Jakavi sales increased by 8% to $555 million [10][12] Strategic Updates - Novartis announced plans to acquire Avidity Biosciences for $12 billion to enhance its late-stage neuroscience pipeline [22][23] - The acquisition aims to strengthen the company's position in addressing genetic neuromuscular diseases [28] - A collaboration agreement with the U.S. government was established to reduce drug prices while supporting ongoing investments in manufacturing and R&D [25] Market Position - Novartis shares have gained 42.1% over the past year, outperforming the industry growth of 19% [2] - The company is navigating significant patent expirations, with a focus on key growth drivers such as Kisqali, Kesimpta, Pluvicto, and Scemblix [26][27]
As Novo Nordisk Stock Breaks Below Key Support Levels, Should You Buy the Dip?
Yahoo Finance· 2026-02-03 22:17
Novo Nordisk (NVO) shares crashed on Tuesday after the Danish drugmaker issued a sobering outlook for 2026 that caught Wall Street flat-footed. According to the pharma giant, its top- and bottom-line growth will decelerate this year as its “Most Favored Nations” agreement with the U.S. lowers weight-loss drug prices in its largest market. More News from Barchart At the time of writing, Novo Nordisk stock is trading some 20% below its year-to-date high. www.barchart.com What This 2026 Outlook Really M ...
Will Reblozyl Shine in Bristol Myers' Fourth-Quarter Results?
ZACKS· 2026-02-03 17:40
Core Insights - Bristol Myers (BMY) is focusing on its growth portfolio, including drugs like Reblozyl, to drive revenue growth in upcoming quarterly results [1][8] - Reblozyl, co-developed with Merck, has annualized sales exceeding $2 billion and is a significant growth driver for the company [1] Sales Performance - Reblozyl generated sales of $1.66 billion in the first nine months of 2025, reflecting a 35% year-over-year increase [3][8] - The Zacks Consensus Estimate for fourth-quarter Reblozyl sales is $636 million, while the model estimate is $641 million [3] Competitive Landscape - Keros Therapeutics is developing elritercept for transfusion-dependent anemia, which may compete with Reblozyl [5] - Reblozyl also faces competition from established erythropoiesis-stimulating agents (ESAs) like Procrit [6] Financial Outlook - BMY's legacy portfolio is under pressure from generic competition, impacting sales of drugs like Revlimid and Pomalyst [4][8] - The Zacks Consensus Estimate for 2025 EPS has decreased to $6.09 from $6.53 over the past 60 days [11] Valuation Metrics - BMY is trading at a price/earnings ratio of 9.23x forward earnings, which is lower than the large-cap pharma industry's average of 18.42x [10]
Merck tops quarterly estimates, posts modest 2026 guidance as generic competition looms
CNBC· 2026-02-03 11:31
Core Viewpoint - Merck reported strong fourth-quarter earnings driven by demand for its cancer immunotherapy Keytruda, but provided a modest 2026 outlook that fell short of Wall Street expectations due to upcoming patent expirations and generic competition [1][2]. Financial Performance - For the fourth quarter, Merck posted net income of $2.96 billion, or $1.19 per share, compared to $3.74 billion, or $1.48 per share, in the same period last year [4]. - Adjusted earnings for the fourth quarter were $2.04 per share, slightly above the expected $2.01 per share [6]. - Revenue for the quarter was $16.4 billion, a 5% increase from the previous year, and exceeded expectations of $16.19 billion [5][6]. 2026 Outlook - Merck anticipates 2026 revenue between $65.5 billion and $67 billion, lower than analysts' expectations of $67.6 billion [2]. - The company expects adjusted earnings per share to be between $5 and $5.15, compared to the analyst estimate of $5.36 [2]. Acquisition and Charges - The 2026 guidance includes a one-time charge of approximately $9 billion, or around $3.65 per share, related to the acquisition of Cidara, which is developing a flu prevention drug [3]. Cost Management - Merck is implementing a cost-cutting plan aimed at reducing expenses by $3 billion by the end of 2027 to offset revenue losses from the upcoming patent expiration of Keytruda in 2028 [5]. Drug Pricing Deal - Under a "most favored nation" deal, Merck will sell existing treatments to Medicaid patients at the lowest price offered in other developed nations and will receive a three-year reprieve from tariffs [4].
BMY Gains 13.1% in Three Months: Buy, Sell or Hold the Stock?
ZACKS· 2025-12-15 15:36
Core Insights - Bristol Myers Squibb Company (BMY) has shown strong performance recently, with shares increasing by 13.1% over the past three months, although this is slightly below the industry's growth of 15.2% [1][4] - The company has outperformed the sector and the S&P 500 during the same period [1][3] Financial Performance - BMY reported better-than-expected Q3 results on October 30, driven by increased demand for key drugs such as Opdivo, Breyanzi, Reblozyl, and Camzyos [4][8] - The company raised its revenue guidance, reflecting strong performance and giving investors renewed confidence [4][8] Growth Portfolio - BMY's Growth Portfolio includes drugs like Opdivo, Reblozyl, and Breyanzi, which have maintained strong top-line growth [5][9] - Opdivo sales in the U.S. are bolstered by its launch in MSI-high colorectal cancer and growth in non-small cell lung cancer, with international sales benefiting from label expansions [6][7] - Reblozyl is annualizing over $2 billion in sales, while Breyanzi is also performing well with annualized sales exceeding $1 billion [9][10] New Drug Approvals and Collaborations - The approval of Opdivo Qvantig for subcutaneous use has enhanced BMY's immuno-oncology portfolio, with expectations for global sales to increase in the high single-digit to low double-digit range by 2025 [7] - BMY's acquisition of Orbital Therapeutics for $1.5 billion will add OTX-201, a promising RNA immunotherapy candidate, to its pipeline [14][15] - Collaborations with BioNTech for bispecific antibodies targeting PD-1 and VEGF are also in progress, indicating a focus on innovative cancer treatments [16] Legacy Portfolio Challenges - BMY's legacy portfolio is facing challenges due to generic competition, with expected declines of 15-17% in sales for legacy drugs by 2025 [12][8] - The legacy portfolio includes Eliquis, which is a significant contributor to revenue but is also under pressure from generics [13] Valuation and Estimates - BMY's shares are currently trading at a price/earnings ratio of 8.78x forward earnings, which is lower than the large-cap pharma industry's average of 16.99x [17] - The Zacks Consensus Estimate for 2025 EPS has increased to $6.51 from $6.43 over the past 60 days, indicating positive sentiment [19] Investment Outlook - BMY is considered a safe haven for investors in the biotech sector, with strong performance from its growth drugs stabilizing revenue amid generic competition [21] - The company offers an attractive dividend yield of 4.73%, making it a compelling option for existing investors [22]