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Globe and Mail
29-07-2025
- Business
- Globe and Mail
AZN Q2 Earnings Meet Estimates, Sales Beat as Key Drugs Outperform
AstraZeneca 's AZN second-quarter 2025 core earnings of $1.09 per American depositary share (ADS) came in line with the Zacks Consensus Estimate. Core earnings of $2.17 per share rose 10% year over year on a reported basis and 12% on a constant exchange rate (CER). Total revenues of $14.46 billion rose 12% on a reported basis and 11% at CER, driven by higher product sales and alliance revenues from partnered medicines. Revenues beat the Zacks Consensus Estimate of $14.03 billion. All growth rates mentioned below are on a year-over-year basis and at CER. AZN's Product Sales & Alliance Revenues Among AstraZeneca's various therapeutic areas, Oncology revenues were up 18%, while Cardiovascular, Renal and Metabolism ('CVRM') product sales rose 3%. The Respiratory & Immunology (R&I) segment's sales rose 12%. While Rare disease revenues rose 7%, sales of Vaccines & Immune (V&I) Therapies rose 54%. Sales of other medicines were down 9%. Product sales rose 10% to $13.8 billion, as strong underlying demand trends for its products were partially offset by new manufacturer discounts under Medicare Part D redesign in the United States. Alliance revenues include royalties and profit share from partnered medicines, such as Enhertu and Tezspire, in geographies where its partner books product sales. Alliance revenues rose 35% to $654 million, driven by continued revenue growth from partnered medicines. Alliance revenues included $436 million from Daiichi Sankyo for Enhertu and $155 million of AstraZeneca's share of gross profits in the United States from partner Amgen AMGN for Tezspire. Alliance revenues also included $10 million from partner Daiichi Sankyo for Datroway and $27 million for Beyfortus. AZN records a 50% share of gross profits from Beyfortus' sales in major ex-U.S. markets and 25% of brand revenues from the rest of the world markets received from partner Sanofi SNY. The company also records Beyfortus product sales from products supplied to partner Sanofi under the V&I Therapies segment. AstraZeneca's Key Oncology Drugs Beat Estimates Here, we have discussed the total revenues of its drugs by including Alliance revenues and Collaboration revenues within each revenue figure. In Oncology, Tagrisso recorded revenues of $1.81 billion, up 12% year over year, on strong demand for all indications and in all regions, which more than offset the impact of Medicare Part D redesign and pricing pressure in some European markets. Tagrisso sales beat the Zacks Consensus Estimate as well as our model estimate of $1.75 billion. Lynparza's total revenues rose 11% to $838 million, driven by increased market share/demand growth for all approved indications. The drug's sales beat the Zacks Consensus Estimate of $810 million and our estimate of $788.7 million. AstraZeneca markets Lynparza in partnership with Merck MRK. During the quarter, the company did not record any milestone payment from partner Merck related to the drug. Imfinzi generated sales of $1.46 billion in the quarter, up 26%, driven by strong growth from launch in bladder and lung cancer indications, partially offset by mandatory price reductions in Japan. Imfinzi sales beat the Zacks Consensus Estimate of $1.37 billion and our estimate of $1.3 billion. Sales of Calquence rose 10% to $872 million in the quarter. New breast cancer drug Truqap recorded $170 million in revenues in the second quarter of 2025 compared with $132 million in the previous quarter. Newly approved drug Datroway, for which it has a partnership with Daiichi Sankyo, recorded revenues of $11 million in the quarter compared with $4 million in the first quarter, driven by encouraging initial launch uptake in the United States. The FDA approved the expanded use of Datroway for a second indication — non-small cell lung cancer in June. AZN's CVRM Segment Performance In CVRM, Farxiga recorded product sales of $2.15 billion, up 10%, driven by continued demand growth across chronic kidney disease and heart failure. Farxiga sales beat the Zacks Consensus Estimate of $2.05 billion and our model estimate of $2.06 billion. Brilinta/Brilique sales totaled $215 million in the reported quarter, down 38%, due to the generic launch in Europe and the United States in the second quarter. New drug Wainua recorded $44 million in product sales during the quarter compared with $39 million in the previous quarter, driven by strong launch momentum in the United States and initial launch in ex-U.S. markets. AZN's R&I Segment Performance In R&I, Symbicort sales declined 1% to $715 million due to generic erosion in Europe and competition from triple therapy on the ICS/LABA class of medicines like Symbicort in China. The drug's sales missed the Zacks Consensus Estimate and our model estimate of $726 million and $732.9 million, respectively. Fasenra recorded sales of $502 million in the quarter, up 18% year over year, driven by strong demand growth and market share gains. The recent launch for the EGPA indication also benefited sales in some countries. The drug's sales beat the Zacks Consensus Estimate as well as our model estimate of$467 million. Breztri recorded sales of $283 million, up 20% year over year. Pulmicort sales declined 32% to $106 million. Tezspire recorded total revenues of $261.0 million, up 65% year over year, driven by demand growth and launch uptake in multiple markets. Amgen records product sales in the United States, and AstraZeneca records its share of U.S. gross profits as Alliance revenues. AstraZeneca books product sales in markets outside the United States. New product Airsupra generated $42 million in product sales in the second quarter, compared with $28 million in the previous quarter. New lupus drug, Saphnelo, recorded sales of $167 million, up 48% year over year. AZN's Rare Disease, V&I and Other Segment In the Rare Disease portfolio, Soliris sales fell 22% to $530 million due to conversion to Ultomiris and biosimilar erosion in Europe. Ultomiris revenues amounted to $1.18 billion, up 23%, driven by patient demand, growth in neurology indications, geographic expansions in new markets and continued conversion from Soliris. The impact of Medicare Part D redesign was minimal in the second quarter. In Other Medicines, sales of Nexium declined 11% to $201 million. In V&I Therapies, AstraZeneca recorded $126 million in revenues from Beyfortus, which included alliance revenues mentioned earlier as well as sales of manufactured Beyfortus product to Sanofi. AZN Maintains 2025 Guidance AstraZeneca maintained its financial guidance for 2025. It expects total revenues to grow by a high single-digit percentage at CER. Core EPS is expected to increase by a low double-digit percentage. Our Take on AZN's Results AstraZeneca reported decent second-quarter results, as its earnings matched estimates and revenues beat the same. Sales of almost all key drugs, including Tagrisso, Lynparza, Imfinzi, Farxiga and Fasenra beat estimates. All these drugs have been driving AstraZeneca's top-line growth over the past several quarters, backed by increasing demand trends. Newer drugs like Wainua, Airsupra, Saphnelo, Datroway (partnered with Daiichi Sankyo) and Truqap also contributed to top-line growth in the second quarter. AstraZeneca also announced an increase in its interim dividend by 3% to $1.03 per share. Shares of the British drugmaker rose around 4% in pre-market trading on Tuesday in response to the strong top-line performance. Year to date, the stock has risen 11.1% compared with the industry 's 3.1% increase. AZN reaffirmed its 2025 guidance. Despite the potential impact from Part D redesign, AstraZeneca expects total revenues to grow by a high single-digit percentage at CER in 2025. Growth momentum in the Oncology and CVRM segments is expected to continue in 2025. However, in Rare Disease, though AstraZeneca expects growth in 2025, it will be at a slower pace than in 2024. Backed by its new products and pipeline drugs, AstraZeneca believes it can post industry-leading top-line growth in the 2025-2030 period. AstraZeneca expects to generate$80 billion in total revenues by 2030, a significant increase from the $54 billion it generated in 2024. By the said time frame, AstraZeneca plans to launch 20 new medicines, with almost half of these already launched/approved. It believes that many of these new medicines will have the potential to generate more than $5 billion in peak-year revenues. The company is also on track to achieve a mid-30s percentage core operating margin by 2026 Earlier this month, AZN announced plans to invest $50 billion by 2030 to boost manufacturing and R&D in the United States to expand domestic production in response to ongoing tariff pressures under President Donald Trump. AZN's Zacks Rank Currently, AstraZeneca has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Higher. Faster. Sooner. Buy These Stocks Now A small number of stocks are primed for a breakout, and you have a chance to get in before they take off. At any given time, there are only 220 Zacks Rank #1 Strong Buys. On average, this list more than doubles the S&P 500. We've combed through the latest Strong Buys and selected 7 compelling companies likely to jump sooner and climb higher than any other stock you could buy this month. You'll learn everything you need to know about these exciting trades in our brand-new Special Report, 7 Best Stocks for the Next 30 Days. Download the report free now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Amgen Inc. (AMGN): Free Stock Analysis Report
Yahoo
06-06-2025
- Business
- Yahoo
2 Dividend Growth Stocks to Buy and Hold Forever
Despite recent headwinds, these drugmakers have strong underlying businesses. Their pipelines should enable them to navigate patent cliffs and support top-line growth. Novartis and Amgen also boast impeccable dividend track records, which should please investors. 10 stocks we like better than Amgen › When broader equities are volatile, it's tempting to focus on what's going to happen in the near term. That's why some investors resort to panic selling -- they anticipate that things will get even worse than they already are. However, one of the formulas for better-than-average long-term returns is to stick with your holding even when the going gets rough, unless there is some fundamental change to a company's investment thesis. In fact, even when the near-term is somewhat uncertain, it's still worth it to invest in corporations that can perform well over many decades. Let's consider two examples in the healthcare sector: Amgen (NASDAQ: AMGN) and Novartis (NYSE: NVS). These drugmakers have a lot to offer long-term, income-oriented investors. Amgen's organic revenue hasn't always grown as fast as Wall Street would have wanted over the past few years. One of the company's promising candidates to change that, investigational weight management product MariTide, did not post phase 2 data on par with what analysts and investors wanted either. Despite these short-term challenges, the company's prospects remain attractive. Clinical setbacks are par for the course for biotech companies, that is, if MariTide results even count as a setback. The medicine produced a mean weight loss of approximately 20% after 52 weeks, with no plateau observed, and all this with convenient once-monthly dosing; the current leading anti-obesity medicines are administered weekly. Even with lower efficacy, MariTide could go on to attract a reasonable number of patients thanks to its friendlier dosing schedule. In addition to this investigational medicine, Amgen boasts a comprehensive lineup of products across several therapeutic areas, including several that generate over $1 billion in annual sales. Despite top-line growth that doesn't always meet or exceed expectations, Amgen generates consistent revenue and profits. The biotech leader also has several medicines in its arsenal that should help it drive decent growth for a while. Asthma treatment Tezspire has been making strides on the market and in the clinic. Tepezza remains the only medicine for thyroid eye disease approved by the U.S. Food and Drug Administration. There are several other key products in Amgen's portfolio. More importantly, the company has a pipeline with dozens of investigational drugs that will allow it to overcome competition and patent cliffs over the long run. Lastly, Amgen has a great dividend track record. It has raised its payouts every year since first initiating them in 2011. In the past decade, Amgen's dividend has increased by 201.3%. It offers a forward yield of 3.3%, well above the S&P 500's average of 1.3%. It is well worth it for income seekers to buy this stock and hold it for good. Novartis, another leading drugmaker, is facing a significant patent cliff this year. The company's heart failure medication, Entresto, is running out of exclusivity in the U.S. That's a big problem since Entresto was Novartis' top-selling medicine last year, generating $7.8 billion in revenue in 2024. Novartis will likely see its revenue decrease for a while, as pharmaceutical giants tend to do when encountering major patent cliffs. However, Novartis should eventually overcome this obstacle. Several newer medicines will help smooth out Entresto-related losses. For instance, Pluvicto, a cancer medicine first approved in the U.S. in 2022, is making steady progress. It is already generating over $1 billion in annual sales and is still going strong. It should keep driving sales growth into the next decade. Leqvio, a therapy to help reduce cholesterol that first hit the U.S. market in 2021, should also help. Some of Novartis' older drugs will maintain an upward sales trajectory for a while, too. The Swiss drugmaker also has a deep pipeline, boasting a little over 100 programs across multiple therapeutic areas. Expect regular brand-new approvals and label expansions for the drugmaker. Lastly, Novartis has an impressive dividend track record. The company's forward yield tops 3.5%, and, importantly, it has increased its dividends for 28 consecutive years. Novartis may not be attractive to growth-oriented investors, particularly as it navigates the Entresto patent cliff. However, the company has a robust business that generates consistent results, a deep pipeline to help mitigate patent-related challenges, and a history of rewarding shareholders with dividend hikes. Investors can safely add this stock to their "forever" dividend portfolio. Before you buy stock in Amgen, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Amgen wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $668,538!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $869,841!* Now, it's worth noting Stock Advisor's total average return is 789% — a market-crushing outperformance compared to 172% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 2, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Amgen. The Motley Fool has a disclosure policy. 2 Dividend Growth Stocks to Buy and Hold Forever was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
29-05-2025
- Business
- Globe and Mail
Is Amgen Stock a Buy?
Amgen (NASDAQ: AMGN) is doing something unusual in 2025. The biotech giant's shares are up 7.2% for the year as I write this while most large-cap healthcare stocks struggle; yet it trades at just 13 times forward earnings estimates compared to 21 for the S&P 500. That disconnect between performance and valuation creates an opportunity. With 14 drugs posting double-digit sales growth in the most recent quarter, a promising obesity drug in late-stage trials, and a 3.5% dividend yield, Amgen offers investors a rare combination of growth, income, and value. Here's why this $150 billion pharmaceutical powerhouse deserves a closer look by investors of all stripes. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Continue » Broad-based growth defies biotech blues Amgen delivered stellar first-quarter 2025 results in early May that demonstrated the power of its diversified portfolio, with total revenue climbing 9% year-over-year to $8.1 billion and non-GAAP earnings per share surging 24% to $4.90. The company's performance was driven by remarkable strength across multiple therapeutic areas, with 14 products achieving double-digit sales growth during the three months, relative to the same period a year ago. Leading the charge was asthma blockbuster Tezspire at 65%, followed by cancer drug Blincyto with explosive 52% growth, the osteoporosis treatment Evenity at 29%, and cholesterol-lowering Repatha at 27%. What makes Amgen's growth particularly noteworthy is its ability to maintain robust profitability while investing heavily in future innovation. The company's non-GAAP operating margin expanded 2.5 percentage points to 45.7% in the first quarter of 2025, demonstrating exceptional operating leverage even as research and development expenses climbed 12% to support late-stage clinical programs. This includes pivotal investments in MariTide, Amgen's highly anticipated obesity drug that could transform the company's growth trajectory. Pipeline promises next wave of blockbusters While Amgen's current portfolio delivers steady growth, the company's late-stage pipeline could unleash a new era of expansion. The crown jewel is MariTide (maridebart cafraglutide), a differentiated obesity treatment that activates the GLP-1 receptor while antagonizing GIPR. With Phase 3 trials now enrolling patients and additional studies launching throughout 2025, MariTide represents a multibillion-dollar opportunity in the white-hot obesity market. Beyond MariTide, Amgen's pipeline depth is impressive. Rocatinlimab for atopic dermatitis has delivered stellar Phase 3 results across multiple studies, with the Ignite trial showing 42.3% of patients achieving significant skin clearance versus just 12.5% for placebo. In oncology, tarlatamab (Imdelltra) just demonstrated improved overall survival in small cell lung cancer, potentially establishing a new standard of care in second-line small cell lung cancer. The company's biosimilar strategy also provides a competitive edge. With successful launches of Pavblu (Eylea biosimilar) and Wezlana (Stelara biosimilar), plus upcoming biosimilars for blockbusters Opdivo and Keytruda, Amgen is well positioned to capture market share as several high-earning biologics lose patent protection in the coming years. Financial fortress with shareholder rewards Amgen's financial profile stands out in the biotech space. The company generated $1 billion in free cash flow during Q1 2025, up from $0.5 billion a year earlier, providing ample resources for both business development and shareholder rewards. Management raised the quarterly dividend 6% to $2.38 per share, resulting in an attractive 3.5% yield at the current stock price. The balance sheet remains rock-solid even after the $27.8 billion Horizon Therapeutics acquisition. Amgen reduced debt by $2.8 billion in Q1 and maintains the flexibility to pursue strategic opportunities while returning cash to shareholders. Full-year 2025 guidance calls for revenue of $34.3 billion to $35.7 billion and non-GAAP earnings per share of $20.00 to $21.20, representing mid-single-digit growth at the midpoint. Is Amgen stock a buy? With shares trading at a significant discount to the broader market, Amgen stock presents a compelling opportunity for value-conscious investors. The combination of 14 products delivering double-digit growth, a potentially transformative obesity drug in late-stage development, and a generous 3.5% dividend yield makes this biotech giant a buy for investors seeking both growth and income at a reasonable price. Should you invest $1,000 in Amgen right now? Before you buy stock in Amgen, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Amgen wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $653,389!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $830,492!* Now, it's worth noting Stock Advisor 's total average return is982% — a market-crushing outperformance compared to171%for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of May 19, 2025
Yahoo
22-05-2025
- Business
- Yahoo
Better Weight Loss Stock: Amgen or Viking Therapeutics?
Amgen's weight loss candidate reported mixed phase 2 data, but the company has other weapons. Viking Therapeutics' leading anti-obesity program aced mid-stage studies, and it's not its only promising candidate. Deciding between these two stocks might come down to each investor's style, priorities, and risk tolerance. 10 stocks we like better than Amgen › Investors looking to cash in on the fast-growing market for weight management medicines will naturally turn to the two leaders in this area, Eli Lilly and Novo Nordisk. However, several other companies seem to have somewhat promising prospects in this field. This group includes Amgen (NASDAQ: AMGN) and Viking Therapeutics (NASDAQ: VKTX), two drugmakers that have produced phase 2 clinical trial data for their leading weight management candidates. Despite these positive clinical developments, Amgen and Viking Therapeutics have performed poorly on the stock market in the past 12 months, though progress in this area might eventually help them bounce back. But which of these two biotechs should investors trying to profit from the rapid spending on anti-obesity medicines put their money in? Amgen's leading weight loss candidate is called MariTide. In November, the biotech reported that in a phase 2 study, the medicine led to an average weight loss of about 20% in overweight or obese patients after 52 weeks, with no weight loss plateau observed. Importantly, MariTide is administered subcutaneously once a month -- the current weight management leaders are taken once weekly. A less frequent dosing could appeal to many patients. The market expected greater weight loss in this study. That's why Amgen's shares fell after it released its phase 2 results. However, the company's data still makes it somewhat likely that it will go on to carve out a solid niche in the rapidly growing weight loss area, although it won't dethrone the leaders. Further, Amgen's prospects go well beyond its work in the anti-obesity market. The company's deep lineup allows it to generate consistent revenue and profits. In the first quarter, Amgen's sales increased by 9% year over year to $8.1 billion, while its adjusted earnings per share came in at $4.90, 24% higher than the year-ago period. Amgen has several growth drivers. Tezspire, an asthma medicine, is performing well, as is Prolia, a treatment for osteoporosis (a bone disease) in postmenopausal women. Amgen also has a deep pipeline of investigational products besides MariTide that will eventually lead to brand-new medicines. Lastly, it is an excellent dividend stock. It offers a forward yield of 3.5% -- compared to the S&P 500 index's average of 1.3% -- and has increased its payouts by 201.3% in the past 10 years. Amgen could generate strong returns over the long run even if MariTide doesn't pan out. Viking Therapeutics is a clinical-stage biotech. The company's VK2735, its weight management candidate, looks promising. Last year, it reported that at the highest dose, the drug led to a placebo-adjusted mean weight loss of 13.1% (or 14.7% from baseline) after a mere 13 weeks. VK2735 is in the same class of drugs as Eli Lilly's Zepbound. It mimics the action of two gut hormones: GLP-1 and GIP. That doesn't guarantee that it will achieve the same kind of success, but so far, the data looks highly encouraging. Viking Therapeutics has other candidates. The company's VK2809 targets metabolic dysfunction-associated steatohepatitis. It delivered solid phase 2 results last year. Viking Therapeutics is also developing an oral formulation of VK2735 that is currently in mid-stage studies, while VK0214 is an investigational treatment for a rare, nervous system disorder called X-linked adrenoleukodystrophy. There is no approved treatment for the disease yet. Viking Therapeutics carries above-average risk, as do all biotech companies without a single product on the market. But if VK2735 aces phase 3 results and earns approval -- and Viking's other candidates pan out as well -- the stock could deliver substantial returns. Amgen is a well-established company that generates consistent financial results. It also pays a dividend. It is a far better option for low-risk, income-seeking investors. There is no contest there. However, Viking Therapeutics has far more upside potential. If the smaller biotech can deliver solid pipeline and regulatory progress in the next few years, its shares will likely skyrocket. Note that the company also has significant potential drawbacks. It could be more appealing for investors with a higher tolerance for volatility. Before you buy stock in Amgen, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Amgen wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $644,254!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $807,814!* Now, it's worth noting Stock Advisor's total average return is 962% — a market-crushing outperformance compared to 169% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 19, 2025 Prosper Junior Bakiny has positions in Eli Lilly, Novo Nordisk, and Viking Therapeutics. The Motley Fool has positions in and recommends Amgen. The Motley Fool recommends Novo Nordisk and Viking Therapeutics. The Motley Fool has a disclosure policy. Better Weight Loss Stock: Amgen or Viking Therapeutics? was originally published by The Motley Fool
Yahoo
21-05-2025
- Business
- Yahoo
AMGN Down 10% in 3 Months: How to Play the Stock as Tariff Woes Linger
Amgen's AMGN stock has declined 10.4% in the past three months. A lot of this price decline is related to the broader macroeconomic uncertainty. Stocks have been on a roller-coaster ride since President Trump unveiled sky-high tariffs in early April and China came up with retaliatory tariffs. Last week, China and the United States struck a deal that eased trade tensions and resulted in a stock market recovery. Though the massive tariffs imposed by the United States and retaliatory tariffs by China and some other countries are now on a pause, it is only a temporary suspension, and no one knows what will happen after the 90-day tariff suspension ends. The uncertainty around tariffs and trade production measures remains, which has muted economic growth. Although pharmaceuticals have been exempted from tariffs in the first round, they could be Trump's target in the next round, considering the President's goal to shift pharmaceutical production back to the United States, primarily from European and Asian countries. Trump and the Republican government also continue to stress on the control of drug prices with the latest attempt being his 'most favored nations' policy.' Let's understand AMGN's strengths and weaknesses to better analyze how to play the stock in the uncertain macro environment. Amgen's revenues grew 9% year over year in the first quarter of 2025, driven by growing patient demand for its innovative medicines. Amgen is seeing declining revenues from oncology biosimilars and some legacy established products like Enbrel. Pricing headwinds and competitive pressure are hurting sales of many products. Sales of some key brands, like Otezla and Lumakras, have been lukewarm. However, revenues from key older medicines like Prolia, Repatha and Blincyto and new drugs like Tavneos and Tezspire are driving the top line. Rare disease drugs like Tepezza, Krystexxa and Uplizna, added from last year's acquisition of Horizon Therapeutics, are also boosting top-line growth. Amgen is also evaluating Kyprolis, Otezla, Nplate, Repatha, Lumakras, Tezspire, Uplizna and Blincyto for additional indications. Approval for the expanded use of these drugs can potentially drive further top-line growth. Uplizna was approved for IgG4-related disease in the United States in April 2025. Amgen's regulatory application for Uplizna in myasthenia gravis is under review in the United States, with an FDA decision expected on Dec. 14, 2025. Tezspire is under review in the United States for chronic rhinosinusitis with nasal polyps, with an FDA decision expected on Oct. 19, 2025. Amgen has invested several billion dollars in M&A deals over the last decade, which has bolstered its product portfolio and diversified its pipeline. Amgen is developing MariTide, a GIPR/GLP-1 receptor, as a single dose in a convenient autoinjector device with a monthly and, possibly, less frequent dosing. This key feature differentiates it from Eli Lilly's LLY and Novo Nordisk's NVO popular GLP-1-based obesity drugs, Zepbound and Wegovy, which are weekly injections. In clinical studies, it has shown predictable and sustained weight loss and a meaningful impact on cardiometabolic parameters. In March, Amgen initiated two phase III studies on MariTide in obesity as part of its comprehensive MARITIME phase III program. Separate phase III studies on MariTide in obesity, with or without type II diabetes, are currently enrolling patients. Additional MARITIME phase III studies on MariTide in specific obesity-related conditions are expected to be launched throughout 2025. Separate phase II studies on obesity and type II diabetes are also ongoing, with data readouts expected in the second half. An interesting BiTE drug, Imdelltra (tarlatamab), was approved for pre-treated advanced small cell lung cancer (ES-SCLC) in May 2024. Several phase III studies are currently ongoing on tarlatamab in earlier-line settings across extensive-stage and limited-stage SCLC. Imdelltra is believed to have blockbuster potential, as there are limited treatment options in late-line SCLC. Another important candidate, rocatinlimab, is being evaluated in phase III studies for atopic dermatitis and prurigo nodularis. Several data readouts are expected over the next six to 12 months, which could be important catalysts for the stock. Amgen has successfully launched some new biosimilar products this year, which generated impressive sales in the first quarter. In January, Amgen launched Wezlana, the first biosimilar version of J&J's JNJ blockbuster drug, Stelara. Wezlana generated sales of $150 million in the quarter. Wezlana was approved by the FDA in 2023 but was not launched until January 2025, as per a settlement with J&J. Amgen launched the first biosimilar version of Regeneron's Eylea, Pavblu, in the fourth quarter of 2024, which generated sales of $99 million in the first quarter of 2025. Another key biosimilar product, Bekemv, a biosimilar version of AstraZeneca's Soliris, was approved in the United States in May 2024 and was launched in the second quarter of 2025. In the first quarter of 2025, Amgen's biosimilar products generated impressive sales of $735 million, which rose 35% year over year. Amgen's new biosimilar launches will play a key role in mitigating the impact of Amgen's upcoming loss of exclusivity (LOE) over the next few years. Phase III studies are ongoing to evaluate biosimilar versions of Bristol-Myers' Opdivo (ABP 206), Merck's Keytruda (ABP 234) and Roche's Ocrevus (ABP 692). Patents for RANKL antibodies (including sequences) for Prolia and Xgeva expired in February 2025 in the United States and will expire in November 2025 in some European countries. Sales of these best-selling drugs are expected to erode significantly in 2025, mainly in the second half, due to patent erosion. Sales of Amgen's rare disease drugs, mainly Tepezza, have slowed down, which is a concern. The Medicare Part D redesign is expected to hurt sales of some of Amgen's drugs in future quarters. Enbrel and Otezla have been selected by the Centers for Medicare & Medicaid Services for Medicare Part D price setting beginning in 2026 and 2027, respectively. Pricing headwinds and competitive pressure are hurting sales of many products. Weakness in some key brands like Otezla and Lumakras creates potential revenue headwinds. Amgen's stock has risen 7.3% so far this year against a decrease of 3.1% for the industry. The stock has also outperformed the sector and S&P 500 index, as seen in the chart below. Image Source: Zacks Investment Research From a valuation standpoint, Amgen is reasonably priced. Going by the price/earnings ratio, the company's shares currently trade at 13.12 forward earnings, which is lower than 14.74 for the industry. The stock is also trading below its five-year mean of 13.80. Image Source: Zacks Investment Research The Zacks Consensus Estimate for earnings has risen from $20.59 to $20.79 per share for 2025 over the past 30 days. For 2026, the consensus mark for earnings has risen from $21.19 to $21.23 per share over the same timeframe. Image Source: Zacks Investment Research After analyzing the factors discussed above, we believe the company is well placed to maintain long-term revenue growth, driven by continued strong volume growth of key drugs, Repatha, Evenity and Prolia and increasing contribution from new innovative medicines like Tezspire, Tavneos and Imdelltra. It is expected to see continued clinical success from its mid- to late-stage pipeline. Though the initial data from MariTide studies were below expectations, MariTide has the potential to be a game-changer for Amgen. Along with all these factors, Amgen's consistently rising estimates, reasonable valuation and decent stock price appreciation are good enough reasons for those who own this Zacks Rank #3 (Hold) stock to stay invested for now. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Johnson & Johnson (JNJ) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report Amgen Inc. (AMGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
