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AMGN Up Almost 14% YTD: Should You Buy, Sell or Hold the Stock?
ZACKS· 2025-08-26 13:10
Key Takeaways Amgen shares have climbed 13.5% YTD, outperforming the industry, sector and S&P 500.Strong sales from Repatha, Evenity, Blincyto and new biosimilars offset legacy product declines.Pipeline focus on MariTide and new biosimilars aims to counter Prolia and Xgeva's patent expiries.Amgen’s (AMGN) stock has risen 13.5% so far this year compared with an increase of 1.6% for the industry. The stock has also outperformed the sector and S&P 500 Index, as seen in the chart below.AMGN Stock Outperforms In ...
Amgen's Repatha, Evenity & Blincyto Drive Sales This Earnings Season
ZACKS· 2025-08-08 15:51
Core Insights - Amgen (AMGN) reported strong quarterly performance with second-quarter 2025 earnings and sales exceeding estimates, showcasing consistent top-line growth [1][3] - Total revenues increased by 9% year over year to $9.2 billion, with product revenues also rising by 9% to $8.77 billion, driven primarily by volume growth despite declining drug prices [1][6] Revenue Performance - Amgen's total revenues rose 9% year over year to $9.2 billion, with product revenues increasing to $8.77 billion [1][6] - Fifteen of Amgen's products, including Repatha, Blincyto, Tezspire, Uplizna, Tavneos, and Evenity, achieved double-digit volume growth [2] - Rare disease drugs contributed significantly, with sales rising 19% year over year to nearly $1.4 billion, now annualizing at over $5 billion [8] Key Drug Performance - Repatha generated revenues of $696 million, up 31% year over year, driven by a 36% increase in volume [5] - Evenity recorded sales of $518 million, up 32% year over year, benefiting from solid volume growth [6] - Prolia revenues decreased by 4% year over year to $1.12 billion due to lower pricing [7] - Blincyto sales rose 45% year over year to $384 million, driven by broad prescribing [12] Oncology and Biosimilars - Amgen's oncology portfolio grew 14% year over year, generating over $2.2 billion in sales [12] - Biosimilar sales surged 40% year over year to $661 million, with new launches contributing to growth [15][16] Established Products and Inflammation Drugs - Sales of established products decreased by 5% year over year to $533 million [22] - Otezla sales increased by 14% to $618 million, driven by volume growth [19] Future Outlook - Amgen raised its revenue and earnings outlook for 2025, expecting total revenues in the range of $35 billion to $36 billion [23] - Key drugs like Repatha, Evenity, Tezspire, and oncology drugs are expected to drive growth, although pricing pressures may offset some gains [24][25]
Amgen(AMGN) - 2025 Q2 - Earnings Call Transcript
2025-08-05 21:32
Financial Data and Key Metrics Changes - Revenues grew by 9% year over year, with volume increasing by 13% [4][10] - Non-GAAP operating expenses rose by 8%, with non-GAAP R&D growth of 18% year over year [33] - Free cash flow generated in the second quarter was $1.9 billion, reflecting operational momentum [33] Business Line Data and Key Metrics Changes - General Medicine sales increased, with Repatha delivering $696 million, up 31% year over year [10][11] - EVENITY sales increased by 32% year over year to $518 million, with significant growth in the U.S. and Japan [11][12] - Rare disease portfolio grew by 19% year over year, delivering nearly $1.4 billion in sales [14] - Oncology portfolio generated $2.2 billion in sales, growing 14% year over year [18] - Biosimilars portfolio sales grew by 40% year over year to $661 million [20] Market Data and Key Metrics Changes - The U.S. market saw continued demand growth across cardiology and primary care [11] - Inflammation treatments showed strong adoption, with TestBio sales up 46% year over year [17] - The biosimilars market is evolving, with Amgen's portfolio generating nearly $12 billion in sales since 2018 [20][86] Company Strategy and Development Direction - The company is focused on innovation and expanding its pipeline, particularly in obesity, rare diseases, and oncology [6][8] - AI is seen as a key driver for enhancing innovation across the company [7][34] - The company aims to improve patient access and affordability while maintaining a commitment to innovation [5][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver innovation and growth in the long term [9][36] - The company anticipates total revenues for 2025 to be in the range of $35 billion to $36 billion [35] - Management acknowledged the need for reform in the U.S. healthcare system to improve medicine affordability [45][46] Other Important Information - The company is investing heavily in its late-stage pipeline, with a focus on Meritide and other key programs [34][36] - Capital expenditures for 2025 are expected to be $2.3 billion to expand network capacity [34] Q&A Session Summary Question: Granularity on Meritide data in Q4 - Management indicated that more data will be shared in due course regarding the phase two type two diabetes study and chronic weight management studies [41][42] Question: Thoughts on drug pricing reforms - Management emphasized the need for reform in the U.S. healthcare system and expressed a willingness to work with the administration to achieve objectives [44][46] Question: Appetite for M&A in rare diseases - Management remains interested in growing the rare disease business both organically and through potential acquisitions [49][50] Question: Design considerations for Meritide CVOT study - Management acknowledged the interest in the recent data from competitors and indicated that they are closely monitoring the situation [65][66] Question: Timeline for filing approval for bimetuzumab - Management has not disclosed the regulatory strategy yet but is excited about the positive results and their implications for patient treatment [70][71] Question: Confidence in the TestBiR COPD program - Management expressed strong confidence in the mechanism and the responder population for the TestBiR program [106][107] Question: Future of obesity treatments - Management is exploring opportunities to augment their offerings in obesity, including the potential for oral small molecules [111]
Amgen(AMGN) - 2025 Q2 - Earnings Call Transcript
2025-08-05 21:30
Financial Data and Key Metrics Changes - In Q2 2025, revenues grew by 9% year over year, reaching $9.2 billion, with volume growth at an impressive 13% [4][10][31] - Non-GAAP operating expenses rose by 8%, with R&D expenses increasing by 18% year over year [32][33] - Free cash flow generated in the second quarter was $1.9 billion, reflecting operational momentum [32] Business Line Data and Key Metrics Changes - General Medicine saw Repatha sales increase by 31% year over year to $696 million, while EVENITY sales grew by 32% to $518 million [10][11][12] - Rare Disease portfolio sales grew by 19% year over year, totaling nearly $1.4 billion, with TEPEZZA growing by 5% [14][15] - Oncology portfolio sales increased by 14% year over year, generating $2.2 billion, driven by the BiTE platform [18][19] Market Data and Key Metrics Changes - The U.S. market showed continued demand growth across cardiology and primary care, with a significant increase in prescriber engagement [11][12] - Biosimilars portfolio sales grew by 40% year over year to $661 million, contributing significantly to top-line growth [20][21] Company Strategy and Development Direction - The company is focused on advancing a world-class pipeline, with significant investments in innovation and AI to enhance productivity [5][33] - There is a strong emphasis on expanding the rare disease portfolio and exploring M&A opportunities in this area [50] - The company aims to maintain rigorous financial discipline while driving innovation in high unmet medical needs [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential, highlighting the importance of innovation and patient access [5][36] - The company anticipates total revenues for 2025 to be in the range of $35 billion to $36 billion, with non-GAAP earnings per share between $20.2 and $21.3 [34] Other Important Information - The company is actively engaged in discussions with government officials regarding pricing and tariffs, emphasizing the need for more innovation [5][44] - The company plans to return capital to shareholders through competitive dividend payments, which increased by 6% compared to 2024 [33] Q&A Session Summary Question: Granularity of data on Meritide maintenance - Management indicated that more data will be shared in due course regarding the phase two type two diabetes study and chronic weight management studies [40][41] Question: Thoughts on drug pricing reforms - Management acknowledged the need for reform in the U.S. healthcare system and expressed a willingness to work with the administration to achieve objectives [43][45] Question: Appetite for M&A in rare diseases - Management reiterated interest in growing the rare disease business both organically and through potential licensing or acquisition opportunities [48][50] Question: Design considerations for Meritide CVOT study - Management noted that they are closely following the field and will share plans for pivotal studies in diabetes and cardiovascular outcomes in due course [65][66] Question: Confidence in Testspire COPD program - Management expressed strong confidence in the mechanism and profile of Testspire, emphasizing the distinct pathways involved [106][108]
Amgen beats on Q2 revenue, slightly raises guidance
CNBC Television· 2025-08-05 20:39
Financial Performance - Amjen's adjusted EPS exceeded expectations at $62 per share, compared to the street's estimate of $529 [1] - Revenue surpassed estimates, reaching $918 billion, against an expected $894 billion [1] - The company is slightly increasing full-year revenue estimates to $35-36 billion, while the street expected $3537 billion [2] - Full-year adjusted EPS guidance is also increasing, but the midpoint is slightly lower than analysts' expectations [3] Product Performance & Market Dynamics - Osteoporosis drug Prolia's revenues met expectations, but it now faces biosimilar competition in the US [1] - Rare disease and cancer drugs showed some strength [2] - There was weakness in inflammation, excluding the drug Otesla [2] Future Outlook - The guidance includes the estimated impact of implemented tariffs but does not anticipate future pharma-specific tariffs or price adjustments [3] - Data from part two of the phase 2 obesity trial is expected in the fourth quarter [3][4]
Alvotech Gears Up to Report Q2 Earnings: Here's What to Expect
ZACKS· 2025-07-30 15:16
Core Viewpoint - Alvotech (ALVO) is set to announce its Q2 2025 earnings results, with expectations of a loss per share of 26 cents and total revenues of $115.4 million [1][5]. Group 1: Revenue Segments - Alvotech recognizes revenues from two segments: Product revenue and License and other revenue [2]. - Product revenue comes from the sale of two approved biosimilars, Simlandi and Selarsdi, which are biosimilars to AbbVie's Humira and JNJ's Stelara, respectively [3]. Group 2: Market Performance - Investors are particularly interested in the sales figures for Simlandi and Selarsdi, which were launched in the U.S. in 2024 and Q1 2025, respectively, but have yet to gain significant market traction [4]. - Year-to-date, ALVO's shares have decreased by 26.5%, contrasting with the industry's growth of 0.6% [4]. Group 3: Pipeline Developments - Alvotech's pipeline includes AVT05, AVT06, and AVT03, with multiple regulatory filings currently under review in the U.S. and EU [5]. - AVT05 is being developed as a proposed biosimilar to JNJ's Simponi, with regulatory decisions expected by the end of the year [7]. - AVT06 is a proposed biosimilar to Bayer and Regeneron's Eylea, with decisions anticipated by the end of 2025 [8]. - AVT03 is a biosimilar candidate to Amgen's Prolia and Xgeva, with the FDA accepting a regulatory filing for review in March 2025 [9]. Group 4: Partnership Expansions - Alvotech and Dr. Reddy's Laboratories have expanded their partnership to co-develop a biosimilar candidate to Merck's Keytruda [10]. Group 5: Earnings Surprise History - Alvotech has a strong earnings surprise history, having beaten estimates in the last three quarters with an average surprise of 244.18% [11]. - In the last reported quarter, the company achieved an earnings surprise of 305.88% [12]. Group 6: Earnings Predictions - Alvotech currently has an Earnings ESP of 0.00%, indicating no predictive advantage for an earnings beat this time [14].
Amgen Gears Up to Report Q2 Earnings: Will the Beat Streak Continue?
ZACKS· 2025-07-30 13:56
Core Viewpoint - Amgen (AMGN) is expected to exceed earnings expectations for Q2 2025, with consensus estimates for sales at $8.86 billion and earnings per share at $5.25, following a previous quarter where it beat earnings expectations by 17.8% [2][9]. Sales Performance - Strong volume growth from products such as Evenity, Repatha, and Blincyto is anticipated to drive sales, although prices are expected to decline due to increased rebates [3][9]. - The Zacks Consensus Estimate for sales of Evenity, Repatha, and Blincyto is $478 million, $673 million, and $385 million, respectively [3]. Product Insights - Sales of RANKL antibodies, Prolia, and Xgeva are expected to benefit from volume growth, despite price declines. However, the expiration of patents for Prolia and Xgeva in the U.S. in February 2025 may lead to significant sales erosion in the latter half of 2025 [5]. - Newer drugs like Tezspire and Tavneos are projected to contribute positively to top-line growth, with consensus estimates of $320 million and $102 million, respectively [6]. Competitive Landscape - Kyprolis is facing competitive pressure, which likely affected its volume growth in Q1 and is expected to continue in Q2, with consensus estimates for sales at $370 million [7]. - Enbrel sales are likely to decline due to lower prices, while Otezla is expected to see gains from volume growth, with estimates of $534 million for Otezla and $805 million for Enbrel [8]. Recent Developments - Sales of rare disease drugs from the acquisition of Horizon are expected to improve in Q2, following lower-than-expected sales in Q1 due to inventory changes [10]. - New biosimilars launched, such as Wezlana and Pavblu, are anticipated to drive sales growth, although fluctuations in quarterly sales are expected [12][13]. Earnings Surprise History - Amgen has a strong earnings surprise history, with an average surprise of 8.34% over the last four quarters and a stock increase of 18.4% year-to-date compared to a 1.9% increase in the industry [14]. Earnings Prediction Model - The earnings prediction model indicates a likely earnings beat for Amgen, with an Earnings ESP of +1.19% and a Zacks Rank of 3 [15][17].
Dr. Reddy's Q1 Earnings Beat Estimates, Generics Sales Boost Revenues
ZACKS· 2025-07-24 16:25
Core Insights - Dr. Reddy's Laboratories Limited (RDY) reported first-quarter fiscal 2026 earnings of 20 cents per American Depositary Share (ADS), exceeding the Zacks Consensus Estimate of 18 cents, and up from 19 cents per ADS in the same quarter last year [1][5] - Revenues increased by 11% year over year to $997 million, surpassing the Zacks Consensus Estimate of $951 million, primarily driven by growth in global generics revenues [1][5] Revenue Breakdown - Global Generics revenues reached INR 75.6 billion, reflecting a 10% year-over-year increase, mainly due to the acquired Nicotine Replacement Therapy portfolio in Europe and strong performance in branded markets [2] - Pharmaceutical Services & Active Ingredients (PSAI) revenues amounted to INR 8.2 billion, up 7% year over year, driven by new active pharmaceutical ingredient launches and favorable foreign exchange, despite lower pricing and softer demand [7] - Revenues in the Others segment totaled INR 1.65 billion, showing significant year-over-year growth [7] Product Launches and Approvals - Dr. Reddy's launched five new products in the United States during the reported quarter, although revenues in the North America segment declined by 11% due to increased price erosion in key products like Lenalidomide [3] - As of June 30, 2025, there were 73 generic filings pending approval from the FDA, including 70 abbreviated new drug applications (ANDAs) and three new drug applications, with 43 of the ANDAs being Paragraph IV filings [3] Financial Metrics - Gross margin decreased by 350 basis points to 56.9% in the first quarter of fiscal 2026, attributed to higher price erosion in generics and reduced operating leverage, partially offset by a favorable product mix [8] - Research and development (R&D) expenses were $73 million, remaining relatively flat year over year [8] - Selling, general and administrative expenses totaled $299 million, up 13% year over year, driven by increased sales and marketing investments [9] Strategic Collaborations - Dr. Reddy's signed a collaboration and license agreement with Alvotech (ALVO) to co-develop and commercialize a biosimilar candidate to Merck's Keytruda, a major cancer drug, with both companies sharing development and manufacturing costs [10][11] - Keytruda generated sales of $29.5 billion in 2024, with a 6% year-over-year increase to $7.21 billion in the first quarter of 2025, highlighting its significance in Merck's revenue growth [12] Market Performance - Shares of Dr. Reddy's have declined by 7.5% year to date, compared to an 11.4% decline in the industry [4]
Amgen vs. Novo Nordisk: Which Pharma Giant Is the Better Buy?
ZACKS· 2025-07-23 14:51
Core Insights - Amgen (AMGN) and Novo Nordisk (NVO) are leading companies in the pharmaceutical industry, with Amgen focusing on oncology and rare diseases, while Novo Nordisk specializes in diabetes and obesity treatments [1][2] Group 1: Amgen (AMGN) - Amgen has a diverse portfolio with strong growth products such as Repatha, Prolia, and Xgeva, which have helped offset declines in legacy drug sales [3][4] - The acquisition of Horizon Therapeutics has expanded Amgen's rare disease offerings, adding drugs like Tepezza and Krystexxa [4] - Amgen is developing an obesity drug, MariTide, which is in late-stage trials and has shown promising weight loss results, although slightly below investor expectations [5][6] - The company has a strong pipeline with drugs targeting various therapeutic areas, including bemarituzumab for gastric cancer and olpasiran for cardiovascular disease [7] - Amgen has launched biosimilars for popular drugs and is developing more in the oncology space [8] - Despite growth prospects, Amgen faces pricing pressures and expected declines in sales for some of its best-selling drugs due to patent expirations [9] Group 2: Novo Nordisk (NVO) - Novo Nordisk leads the GLP-1 market with a 54% market share, driven by successful products like Ozempic and Wegovy [12] - The company is expanding its manufacturing capacity to support the growing demand for its diabetes and obesity treatments [13] - Novo is pursuing new indications for semaglutide, which could enhance its market position [14] - However, the company faces competition from Eli Lilly and challenges related to disappointing data from its next-generation obesity drug, CagriSema [15][16] - A leadership transition is underway as CEO Lars Fruergaard Jørgensen steps down, which may impact investor sentiment [16] - Novo is also working to expand its rare disease portfolio, with plans to submit a regulatory filing for Mim8 [17] Group 3: Financial Performance and Valuation - Amgen's 2025 sales and EPS estimates suggest a 5% year-over-year increase, with positive revisions in the past 60 days [18] - In contrast, Novo's 2025 sales and EPS estimates imply a significant increase of around 20% and 21%, respectively, although 2026 EPS estimates have declined [20] - Year-to-date, Amgen's shares have gained 17%, while Novo's shares have dropped 22%, against a 3% decline in the industry [21] - From a valuation perspective, Novo Nordisk trades at a higher P/E ratio of 15.51 compared to Amgen's 14.5 [22] - Amgen offers a higher dividend yield of 3.1% compared to Novo's 2.5% [26] Group 4: Investment Considerations - Both companies hold a Zacks Rank 3 (Hold), making it challenging to choose one over the other [28] - Amgen is viewed as a better pick due to its diversified portfolio and attractive valuation, despite facing short-term challenges [29] - Novo Nordisk's strong revenue growth in the GLP-1 space is tempered by limited diversification and ongoing challenges [30]
Amgen (AMGN) is a Top-Ranked Growth Stock: Should You Buy?
ZACKS· 2025-07-14 14:46
Company Overview - Amgen is one of the largest biotech companies globally, with a strong presence in oncology/hematology, cardiovascular disease, inflammation, bone health, and rare diseases markets [11] - The company has developed successful drugs such as Epogen and Neupogen, and launched next-generation products like Aranesp and Neulasta [11] - Amgen's acquisition of Immunex Corporation provided access to the blockbuster drug Enbrel, although older drugs are facing declining sales due to competition [11] Financial Performance - Amgen has a Zacks Rank of 3 (Hold) and a VGM Score of A, indicating a solid position in the market [12] - The company is forecasted to achieve year-over-year earnings growth of 5.1% for the current fiscal year [12] - Recent upward revisions in earnings estimates by five analysts for fiscal 2025 have increased the Zacks Consensus Estimate by $0.09 to $20.85 per share [12] - Amgen has an average earnings surprise of +8.3%, reflecting its ability to exceed earnings expectations [12] Investment Potential - With a solid Zacks Rank and top-tier Growth and VGM Style Scores, Amgen is recommended for investors looking for growth opportunities [13]