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RDY & ALVO Ink Collaboration Deal for Merck's Keytruda Biosimilar
ZACKS· 2025-06-05 16:31
Core Insights - Dr. Reddy's Laboratories (RDY) has entered into a collaboration and license agreement with Alvotech (ALVO) to co-develop and commercialize a biosimilar candidate to Merck's Keytruda, a leading PD-L1 inhibitor [1][8] Group 1: Collaboration Details - The agreement entails that RDY and ALVO will jointly share all costs associated with the development and manufacturing of the biosimilar candidate [3] - Both companies will retain the rights to commercialize the product globally upon successful development [3][8] Group 2: Market Impact - The collaboration is expected to significantly enhance Dr. Reddy's biosimilar portfolio, particularly in emerging markets, and strengthen its capabilities in oncology [4][8] - Keytruda generated sales of $29.5 billion in 2024, with a year-over-year growth of 6% to $7.21 billion in Q1 2025, highlighting the potential market opportunity for the biosimilar [2] Group 3: Previous Agreements - RDY and ALVO had previously signed a license and supply agreement in 2024 for the commercialization of AVT03, a biosimilar candidate to Amgen's Prolia and Xgeva [9] - The FDA accepted a regulatory filing for AVT03 in March 2025, indicating progress in their biosimilar development efforts [9][10] Group 4: Strategic Focus - The introduction of AVT03 could enhance patient access to affordable treatment options for osteoporosis and other bone-related conditions, addressing a significant healthcare need [11][12] - Dr. Reddy's is actively diversifying its generics portfolio to strengthen its market position [12]
Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1]
Globenewswire· 2025-06-02 05:00
Core Viewpoint - Sandoz has launched WYOST® and Jubbonti®, the first and only interchangeable FDA-approved denosumab biosimilars in the US, aimed at improving access to treatment for osteoporosis and cancer-related skeletal events [2][7]. Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a growth strategy focused on pioneering access for patients. The company recorded net sales of USD 10.4 billion in 2024 and has a portfolio of approximately 1,300 products [21]. Product Launch Details - WYOST® and Jubbonti® are approved for all indications of the reference medicines XGEVA® and Prolia®, respectively, and are integral to Sandoz's growth strategy in the biosimilar market [2][3]. - The products are designed to provide high-quality, cost-effective treatment options, enhancing patient access and affordability in the US [3][5]. Patient Impact - The introduction of these biosimilars is expected to significantly improve treatment access for over 10 million US adults aged 50 and older living with osteoporosis, as well as for approximately 330,000 individuals with bone metastases [5][6]. - Sandoz is providing comprehensive support resources for patients prescribed these medications, including reimbursement and financial assistance [4]. Regulatory Approval - Both WYOST® and Jubbonti® have been approved as interchangeable with their reference medicines, ensuring they have the same dosage form, route of administration, and dosing regimen [3][6].
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]
Amgen vs Bristol Myers: Which Biotech Giant Has Better Prospects?
ZACKS· 2025-05-19 18:31
Core Viewpoint - Amgen and Bristol Myers Squibb are leading biotechnology companies with diverse portfolios, making it challenging to choose between them based on their fundamentals, growth prospects, challenges, and valuations [1][2]. Amgen (AMGN) - Amgen has a vast global footprint and a diverse portfolio, with growth products like Prolia, Xgeva, Evenity, Vectibix, Nplate, Kyprolis, and Blincyto stabilizing revenue despite declining sales from legacy drugs [3][4]. - Increased pricing pressures and competition from biosimilars are expected to negatively impact sales of Prolia and Xgeva starting in 2025 [4]. - Key drug Repatha is driving growth, and the approval of Tezspire for severe asthma has strengthened Amgen's portfolio [4][5]. - Amgen has promising candidates in its pipeline, including a broad phase III program on MariTide targeting obesity and type-II diabetes, with data readouts expected in the second half of 2025 [5]. - The acquisition of Horizon Therapeutics has expanded Amgen's rare disease business significantly [6]. - The Zacks Consensus Estimate for Amgen's 2025 sales indicates a year-over-year increase of 5.31%, with EPS expected to improve by 4.79% [13]. - Amgen's shares have gained 6.2% this year, trading at 13X forward earnings, indicating a higher valuation compared to BMY [16][17]. Bristol Myers Squibb (BMY) - BMY's growth portfolio, including drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition for legacy drugs [7][8]. - Reblozyl has shown strong performance in the U.S. and international markets, expected to contribute significantly in the coming decade [7]. - Opdivo maintains momentum with consistent label expansions, and the recent FDA approval of Cobenfy for schizophrenia broadens BMY's portfolio [9][10]. - Despite newer drugs boosting sales, generic competition for legacy drugs has led to a 20% decline in legacy portfolio revenues in Q1 due to impacts from Revlimid and others [11]. - BMY's strategy of acquiring promising companies has resulted in substantial debt, with long-term debt at $46.1 billion as of March 31, 2025 [12]. - The Zacks Consensus Estimate for BMY's 2025 sales implies a year-over-year decrease of 4.10%, while EPS suggests a significant increase of 499.13% [14]. - BMY's shares have lost 15.5% this year, trading at a lower valuation of 7.10 for forward earnings [16][17]. Comparison and Conclusion - Both companies offer attractive dividend yields, with BMY at 5.30% and AMGN at 3.49% [20]. - AMGN is viewed as a better pick currently due to solid fundamentals and recent positive estimate revisions, despite its higher valuation [23].
Compared to Estimates, BeiGene (ONC) Q1 Earnings: A Look at Key Metrics
ZACKS· 2025-05-07 14:35
Core Insights - BeiGene, Ltd. reported $1.12 billion in revenue for Q1 2025, marking a 48.6% year-over-year increase and an EPS of $1.22 compared to -$2.41 a year ago [1] - The revenue matched the Zacks Consensus Estimate of $1.12 billion, resulting in a slight surprise of -0.65%, while the EPS exceeded expectations with a surprise of +271.83% [1] Financial Performance - Product revenue totaled $1.11 billion, slightly below the estimated $1.12 billion by analysts [4] - Key product revenues included: - BRUKINSA (Zanubrutinib): $791.66 million vs. $820.07 million estimated - Tislelizumab: $171.16 million vs. $171.33 million estimated - XGEVA: $70.42 million vs. $56.55 million estimated - Other: $17.90 million vs. $14.28 million estimated - POBEVCY: $13.75 million vs. $16.11 million estimated - BLINCYTO: $23.91 million vs. $20.42 million estimated - KYPROLIS: $19.73 million vs. $16.51 million estimated - Collaboration revenue was $8.75 million, exceeding the $6.49 million estimate [4] Market Performance - BeiGene's shares have returned +15.4% over the past month, outperforming the Zacks S&P 500 composite's +10.6% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected 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].