REYKJAVIK, Iceland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for AVT03, Alvotech’s proposed biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use ...

Core Viewpoint - Alvotech has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval for its biosimilar AVT03, which is a proposed alternative to Prolia® and Xgeva® [1][4] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to provide affordable biologic treatments to patients worldwide [7] - The company has already approved and marketed two biosimilars, with a pipeline that includes nine additional candidates targeting various diseases [7] Product Details - AVT03 is a human monoclonal antibody biosimilar candidate to Prolia® (denosumab 60 mg/mL) and Xgeva® (denosumab 70 mg/mL) [5] - Prolia® is indicated for treating osteoporosis and bone loss in specific patient populations, while Xgeva® is used to prevent bone complications in advanced cancer patients [3] Commercial Partnerships - Upon approval, AVT03 will be marketed by Alvotech's partners, STADA and Dr. Reddy's, each holding semi-exclusive commercial rights in Europe, including Switzerland and the UK [1][4] - STADA will market the biosimilar under the names Kefdensis® and Zvogra®, while Dr. Reddy's will use the names Acvybra® and Xbonzy® [4] Regulatory Status - AVT03 is currently under review by the EMA, with a final decision pending from the European Commission [4]

Core Insights - Amgen's stock has increased by 13.5% year-to-date, outperforming the industry, sector, and S&P 500 Index [1][9][10] Revenue Drivers - Key medicines such as Repatha, Evenity, and Blincyto, along with newer products like Tavneos and Tezspire, are driving sales growth, compensating for declines in oncology biosimilars and mature products like Enbrel [4][7][10] - Revenues increased by 9.4% in the first half of 2025 due to rising patient demand for innovative medicines [6] - Rare disease drugs from the acquisition of Horizon Therapeutics are also contributing to revenue growth [7] Pipeline Developments - Amgen is focusing on the obesity candidate MariTide, which is in phase III studies, and has shown promising results in clinical trials [12][14] - Additional indications for existing drugs like Kyprolis and Uplizna are being evaluated, with potential approvals expected to drive further growth [8][10] Biosimilars Performance - New biosimilars launched in 2025, including Wezlana and Pavblu, generated significant sales, contributing to a total of $1.4 billion from biosimilars in the first half of 2025 [18][20] - Amgen's biosimilars have accumulated nearly $12 billion in sales since their first launch in 2018, enhancing top-line growth [20] Competitive Landscape - Sales of key drugs Prolia and Xgeva are expected to decline due to biosimilar competition following patent expirations [22] - Pricing pressures and competitive challenges are impacting sales of some products, particularly Otezla and Lumakras [23] Valuation and Estimates - Amgen's shares are trading at a price/earnings ratio of 13.53, lower than the industry average of 14.85, indicating reasonable valuation [24] - Consensus estimates for earnings per share have increased for 2025 and 2026, reflecting positive sentiment [27][29]

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]

Core Viewpoint - Amgen Inc. reported strong second-quarter results, surpassing analyst expectations, but its shares are trading lower due to ongoing investor concerns about its experimental weight-loss drug, MariTide [1][4]. Financial Performance - Adjusted earnings for the second quarter were $6.02 per share, a 21% increase year over year, exceeding the consensus estimate of $5.24 [1]. - Quarterly sales reached $9.18 billion, up 9%, also beating Wall Street's estimate of $8.87 billion [1]. - Product sales grew by 9%, driven by a 13% increase in volume, partially offset by a 3% decrease in net selling price [2]. Future Outlook - Amgen raised its fiscal year 2025 adjusted earnings guidance from a range of $20.00-$21.20 per share to $20.20-$21.30, compared to the consensus of $20.89 [3]. - The sales outlook was increased from $34.30 billion-$35.70 billion to $35 billion-$36 billion, against a consensus of $35.29 billion [3]. Product Focus - Investor attention is heavily focused on MariTide, an experimental weight-loss drug, with ongoing Phase 2 studies for chronic weight management and type 2 diabetes [4][5]. - Data readout for the studies is expected in the fourth quarter of 2025 [4][5]. - Analysts express concerns about the trial's ability to address tolerability issues that investors are debating [5]. Competitive Landscape - Amgen has seen clinical and commercial success with several products, including Repatha and Evenity, which support long-term growth prospects [6]. - The company faces near-term challenges from legacy products and competition from biosimilars, but upcoming clinical catalysts are expected to generate investor interest [6]. Stock Performance - As of the latest check, Amgen's stock is trading lower by 5.10% at $284.97 [7].

Core Insights - Amgen reported strong second-quarter 2025 results with adjusted earnings of $6.02 per share, exceeding the Zacks Consensus Estimate of $5.26 per share, and a 21% year-over-year increase in earnings [1][10] - Total revenues reached $9.2 billion, surpassing the Zacks Consensus Estimate of $8.9 billion, marking a 9% year-over-year growth [1][10] Revenue Breakdown - Total product revenues increased by 9% year-over-year to $8.77 billion, driven by a 13% rise in volume, although this was partially offset by price declines [2] - Other revenues amounted to $408 million, reflecting a 17.6% year-over-year increase [2] Key Drug Performance - Evenity sales reached $518 million, up 32% year-over-year, exceeding both the Zacks Consensus Estimate of $478 million and the model estimate of $461.8 million [3] - Repatha generated revenues of $696 million, a 31% increase year-over-year, also beating the Zacks Consensus Estimate of $672 million [4] - Prolia revenues were $1.12 billion, down 4% year-over-year, aligning with the Zacks Consensus Estimate but slightly exceeding the model estimate of $1.01 billion [5] - Xgeva recorded revenues of $532 million, down 5% year-over-year, surpassing the Zacks Consensus Estimate of $508 million [5] - Otezla sales were $618 million, up 14% year-over-year, beating the Zacks Consensus Estimate of $535 million [7] - Tezspire sales increased by 46% year-over-year to $342 million, exceeding the Zacks Consensus Estimate of $326 million [7] Pipeline Developments - Amgen is developing MariTide, a GIPR/GLP-1 receptor, which has shown strong efficacy in clinical studies, with plans for multiple phase III studies ongoing [17][19] - The company has initiated studies evaluating cardiovascular outcomes and heart failure events in obese adults [19] Financial Guidance - Amgen raised its 2025 revenue guidance to a range of $35.0 billion to $36.0 billion, up from the previous expectation of $34.3 billion to $35.7 billion [13] - Adjusted earnings per share guidance was increased to a range of $20.20 to $21.30 [14] - Adjusted operating margin expectations were slightly lowered to approximately 45% due to increased R&D costs [15] Market Performance - Year-to-date, Amgen's stock has risen by 17.1%, outperforming the industry average increase of 3.2% [22] - Despite strong quarterly results, Amgen's shares experienced a slight decline in after-hours trading [21]

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].

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].

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]

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]