Otezla

Search documents
Merck Faces Multiple Challenges: Will It Steer Through Successfully?
ZACKS· 2025-07-09 14:25
Key Takeaways MRK faces major headwinds as Keytruda, its top seller, nears the loss of exclusivity in 2028. Gardasil sales dropped 40% in Q1 2025 due to weak China demand, despite strength in other regions. MRK expects IRA's Medicare drug pricing to impact Januvia in 2026 and Keytruda starting in 2028.Merck (MRK) is expected to face several hurdles over the next few years that could affect its long-term growth trajectory, starting with the anticipated loss of exclusivity of its blockbuster PD-L1 inhibitor ...
Amgen (AMGN) Earnings Call Presentation
2025-06-27 09:28
MariTide Update Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our p ...
Pfizer to Face Several Headwinds: Can It Successfully Navigate Them?
ZACKS· 2025-06-24 15:26
Key Takeaways PFE expects steady 2025 COVID sales but anticipates major LOE losses and IRA headwinds in the future. Medicare Part D changes may cut into sales of key PFE drugs like Vyndaqel, Ibrance, Xtandi and Xeljanz. PFE trades at 7.82x forward earnings, below industry average, with EPS estimates rising for 2025 and 2026.Pfizer (PFE) is likely to encounter several headwinds in the next couple of years that can hurt its sales and profits, the first being declining sales of COVID products, Comirnaty and ...
The Smartest High-Yielding Dividend Stocks in the Nasdaq Composite Index to Buy With $1,500 Right Now
The Motley Fool· 2025-05-24 11:15
Market Overview - The stock market is experiencing volatility, with the S&P 500 index falling nearly 20% from February highs but recovering fully by May 22 [1] - Investors are concerned about high tariffs, a proposed major tax bill, and the potential for recession or rising inflation [1] Amgen - Amgen is a pharmaceutical company known for its diverse range of drugs, including Enbrel, Prolia, XGEVA, Otezla, and Repatha [3] - The company is developing a weight-loss drug, MariTide, and has initiated two phase 3 trials [4] - In Q1, Amgen reported adjusted earnings of $4.90 per share, surpassing Wall Street estimates of $4.26, with revenue growth of 9% year over year [6] - Amgen has consistently paid dividends since 2011, increasing them for 14 consecutive years, with a current dividend yield of approximately 3.5% [7] - Management expects free cash flow to rebound to $7.4 billion in 2023, covering the expected $5.2 billion in dividend payments [7] Sirius XM - Sirius XM is a leading digital audio company in the U.S., operating Sirius satellite radio and Pandora, reaching 160 million listeners monthly [8] - The company has faced significant challenges, with stock down about 57% over the last five years due to rising competition and declining subscribers [8] - Management is investing in technology, expanding its podcast network, and streamlining subscription offerings, aiming for a 25% increase in subscribers to 50 million and a 50% increase in free cash flow to $1.8 billion [9] - In Q1, Sirius XM's revenue fell 4.3% year over year, and total U.S. subscribers declined by 2% [10] - The company offers a 4.9% dividend yield, having regularly paid and increased its annual dividend since 2017, with a trailing free cash flow yield close to 10% [11]
Regeneron Prevails over Amgen in Antitrust PCSK9 Lawsuit Protecting Biotech Innovation and Patient Access to Life-Saving Treatments
Globenewswire· 2025-05-15 18:02
Core Viewpoint - A federal court jury found Amgen liable for antitrust violations, awarding Regeneron $135.6 million in compensatory damages and $271.2 million in punitive damages due to Amgen's anticompetitive practices that hindered competition for Praluent [1][3]. Summary by Relevant Sections Antitrust Violations - Amgen was found to have violated multiple laws, including the Clayton Act and Sherman Act, by using cross-therapeutic bundled rebates to favor Repatha over Praluent, thereby preventing fair competition [1][2]. Jury Verdict and Damages - The jury awarded Regeneron a total of $406.8 million, comprising $135.6 million in compensatory damages and $271.2 million in punitive damages aimed at deterring similar future conduct [3]. Company Statements - Regeneron emphasized the importance of fair competition in the biotech industry, stating that anticompetitive tactics undermine patient access to innovative therapies and hinder medical advancements [4]. Product Information - Praluent, developed by Regeneron and Sanofi, is designed to lower LDL cholesterol levels by inhibiting PCSK9, and is approved in 60 countries [6][7]. Technology and Innovation - Regeneron's proprietary VelocImmune technology has been instrumental in developing fully human monoclonal antibodies, contributing to a significant portion of FDA-approved treatments [8][9].
AMGN's Key Drugs Repatha, Evenity & Blincyto Drive Q1 Sales Growth
ZACKS· 2025-05-05 13:05
Core Viewpoint - Amgen (AMGN) reported strong first-quarter earnings and sales for 2025, with total revenues increasing by 9% year over year and product revenues rising by 11% to $7.87 billion, driven by volume growth despite price declines [1][2][3] Revenue Performance - Total revenues rose 9% year over year, with product revenues increasing 11% to $7.87 billion, reflecting strong volume growth across all areas [1][2] - Sales of key products such as Prolia, Xgeva, Repatha, Blincyto, and Evenity exceeded estimates, with 14 products achieving double-digit volume growth [3][4] Key Drug Performance - Repatha generated $656 million in sales, up 27% year over year, with volume growth of 41% offset by a 9% price decline [4] - Evenity recorded sales of $442 million, a 29% increase year over year, driven by strong demand [5] - Prolia revenues reached $1.1 billion, up 10% from the previous year, as higher volumes mitigated lower pricing impacts [5] Rare Disease Drug Sales - Sales of rare disease drugs rose 3% year over year to $1 billion, with Tepezza and Krystexxa impacted by U.S. wholesaler inventory changes [8][9] - Tepezza sales declined 10% to $381 million, while Krystexxa remained flat at $236 million; Uplizna grew 14% to $91 million, and Tavneos saw a 76% increase to $90 million [9] Oncology Portfolio - Amgen's oncology portfolio grew 10% year over year, generating over $2 billion in sales, with Blincyto as a key driver at $370 million, up 52% [10][11] - Xgeva delivered revenues of $566 million, while Kyprolis saw a 14% decline to $324 million due to competitive pressures [11] Biosimilars Contribution - Biosimilar portfolio sales increased by 35% year over year to $735 million, with new products like Wezlana contributing significantly [12][13] - Wezlana generated $150 million in sales, while Pavblu brought in $99 million [13] Inflammation Drugs - Otezla sales were $437 million, up 11%, while Enbrel revenues declined 10% to $510 million, with both products beating estimates [15] Overall Conclusion - Amgen's key medicines, including Evenity, Repatha, and Blincyto, drove sales growth, offsetting declines from oncology biosimilars and established products like Enbrel [16] - Increased pricing pressures and competition are expected to impact sales of several products, with potential revenue headwinds from brands like Otezla and Lumakras [17]
Compared to Estimates, Amgen (AMGN) Q1 Earnings: A Look at Key Metrics
ZACKS· 2025-05-01 22:30
Core Insights - Amgen reported $8.15 billion in revenue for Q1 2025, a year-over-year increase of 9.4% and an EPS of $4.90, up from $3.96 a year ago, exceeding both revenue and EPS consensus estimates [1] Financial Performance - Revenue of $8.15 billion surpassed the Zacks Consensus Estimate of $7.95 billion by 2.47% [1] - EPS of $4.90 exceeded the consensus estimate of $4.16 by 17.79% [1] - Total product sales reached $7.87 billion, compared to the average estimate of $7.59 billion, reflecting a year-over-year change of 10.6% [4] Product Sales Breakdown - Neulasta (ROW): $20 million, -35.5% YoY, below estimate of $26.10 million [4] - Neulasta (U.S.): $109 million, +25.3% YoY, above estimate of $67.86 million [4] - Otezla (ROW): $94 million, -6.9% YoY, below estimate of $103.34 million [4] - Otezla (U.S.): $343 million, +17.1% YoY, above estimate of $299.70 million [4] - BLINCYTO: $370 million, +51.6% YoY, above estimate of $337.78 million [4] - Repatha: $656 million, +26.9% YoY, above estimate of $615.59 million [4] - KYPROLIS: $324 million, -13.8% YoY, below estimate of $381.49 million [4] - Vectibix: $267 million, +8.1% YoY, above estimate of $250.50 million [4] - Enbrel: $510 million, -10.1% YoY, slightly above estimate of $502.53 million [4] - Other revenues: $276 million, -16.1% YoY, below estimate of $347.10 million [4] - Neulasta (Total): $129 million, +9.3% YoY, above estimate of $93.87 million [4] Stock Performance - Amgen shares returned -4.8% over the past month, compared to the Zacks S&P 500 composite's -0.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market [3]
Amgen(AMGN) - 2025 Q1 - Earnings Call Presentation
2025-05-01 20:23
Q1 '25 Earnings Call May 1, 2025 Safe Harbor Statement This presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (a ...
Can Amgen Keep the Beat Streak Alive This Earnings Season?
ZACKS· 2025-04-29 11:45
Core Viewpoint - Amgen is set to report its first-quarter 2025 results on May 1, with expectations of strong sales driven by volume growth in key products, although pricing pressures may impact overall revenue [1][4]. Sales Estimates - The Zacks Consensus Estimate for first-quarter sales is $7.96 billion, with earnings expected at $4.16 per share [1]. - Specific sales estimates for key products include Evenity at $406 million, Repatha at $616 million, Kyprolis at $381 million, and Blincyto at $333 million [2]. Patent Expiration Impact - Patents for Prolia and Xgeva expired in February 2025 in the U.S., leading to anticipated significant sales erosion due to biosimilar competition, with estimates of $990 million for Prolia and $542 million for Xgeva [3]. New Product Contributions - Newer drugs like Tezspire and Tavneos are expected to contribute positively to top-line growth, alongside the successful launch of Imdelltra for advanced small cell lung cancer [4]. Declining Sales of Established Products - Sales of Enbrel and Otezla are projected to decline due to price reductions and historical trends related to benefit plan changes and increased co-pay expenses [5][6]. Biosimilars Performance - Increased competition is expected to negatively impact revenues from oncology biosimilars, while sales of Amjevita/Amgevita are likely to have increased [7]. - Amgen launched biosimilars Wezlana and Pavblu, with investors keenly observing their sales performance [8]. Operating Margin Expectations - Amgen anticipates the lowest operating margin of the year at around 42% for the first quarter, with R&D costs expected to rise while SG&A costs as a percentage of sales are projected to decline [9]. Earnings Surprise History - Amgen has a strong earnings surprise history, beating estimates in the last four quarters with an average surprise of 5.23% [10]. Earnings Prediction Model - The current model does not predict a definitive earnings beat for Amgen, with an Earnings ESP of -0.05% and a Zacks Rank of 3 [12].