Amgen targets $37B-$38.4B revenue by 2026, what are the key risks to achieving this growth?

``` The deep research logic is organized as follows: Okay, let's tackle this question about Amgen's revenue targets for 2026. The user is asking about the key risks Amgen faces in achieving their $37B to $38.4B revenue goal. First, I need to go through the provided references to gather relevant information. Looking at the references, several articles mention biosimilar competition, especially around denosumab. For example, reference 2 and 13 talk about denosumab biosimilars expected to launch in 2026, which could cause a $5B headwind. That's a significant risk because denosumab is a major product for Amgen. Also, the 340B program utilization is mentioned in reference 13 as a factor that could impact revenue. The 340B program allows certain hospitals to buy drugs at discounted prices, which might reduce Amgen's margins. Another point is the competitive pressure from other companies. Reference 22 mentions that obesity drugmakers faced a slump due to Novo Nordisk's sales forecast, which could affect Amgen's MariTide. Also, Repatha might face competition from Merck's PCSK9 inhibitor, Enlicitide, as noted in reference 10 and 24. This could eat into Repatha's market share. Pricing pressures are another concern. Reference 3 and 9 mention a 4% decrease in selling prices and a mid-single-digit net price decline for 2026. This could offset some of the volume growth Amgen is expecting. Additionally, regulatory risks, like the FDA's dialogue on TAVNEOS (reference 13), might delay approvals or cause unexpected issues. Looking at the user profile, they prefer NASDAQ stocks and have a long-term approach. So, the answer should highlight both short-term risks and long-term strategic challenges. The user might be interested in how Amgen's pipeline and R&D investments can mitigate these risks. For example, MariTide's potential in obesity and cardiovascular treatments could be a growth driver, but the Phase 3 trials are still pending, which introduces uncertainty. I should structure the answer by listing each risk with supporting data from the references. Using tables would help organize the information clearly. Also, since the user likes growth stocks, emphasizing the pipeline's potential alongside the risks would provide a balanced view. Need to make sure each point is backed by the correct citation and that the conclusion ties everything together, highlighting the key takeaways for the user's investment strategy. ``` ### **Conclusion** Amgen’s 2026 revenue target of $37B–$38.4B faces **three critical risks**: biosimilar competition, pricing pressures, and regulatory uncertainties. These risks could offset the company’s growth momentum from blockbuster drugs like Repatha and EVENITY, as well as its pipeline innovations in obesity and cardiovascular treatments. Below is a detailed analysis of these risks, supported by data from recent earnings calls and market updates. --- ### **Key Risks to Amgen’s 2026 Revenue Growth** | **Risk Category** | **Details** | **Potential Impact** | **Mitigation Strategy** | |----------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | **1. Biosimilar Competition** | - Denosumab (Prolia) faces $5B in biosimilar losses in 2026 . - Biosimilar launches for other products (e.g., Enbrel) could erode market share. | - Revenue decline of ~10% for denosumab . - Marginal pricing pressures on legacy products. | - Diversification into high-growth areas like obesity (MariTide) and rare diseases . - Expansion of direct-to-patient programs (e.g., Amgen Now) to retain market share . | | **2. Pricing Pressures** | - 340B program utilization increases, reducing net prices . - Medicare price cuts for Enbrel (-48% YoY sales drop in Q4 2025) . | - Mid-single-digit net price declines in 2026 . - Revenue shortfall in core franchises (e.g., arthritis drugs). | - Focus on premium-priced products (e.g., Repatha, Tezspire) with strong formulary coverage . - Cost-cutting measures (e.g., $6B debt retirement in 2025) to maintain margins . | | **3. Regulatory & Market Risks** | - FDA delays for TAVNEOS (anti-inflammatory drug) . - Competition from Novo Nordisk and Merck in obesity/cardiovascular markets . | - Delayed revenue from MariTide (Phase 3 results expected in Q1 2027) . - Market share erosion for Repatha due to Merck’s PCSK9 inhibitor (Enlicitide) . | - Accelerated R&D spending ($7.2B in 2025) to advance late-stage pipeline . - Strategic acquisitions (e.g., Dark Blue Therapeutics for oncology) to diversify revenue streams . | --- ### **Analysis of Risks** #### **1. Biosimilar Competition** Amgen’s largest product, denosumab (Prolia), faces a $5B revenue headwind in 2026 due to biosimilar competition . Biosimilar launches for other products like Enbrel (arthritis treatment) could further erode market share. However, Amgen is mitigating this risk by: - Expanding its pipeline in high-growth areas like obesity (MariTide) and rare diseases, which are less susceptible to biosimilar competition . - Launching direct-to-patient programs (e.g., Amgen Now) to retain market share for premium-priced products like Repatha . #### **2. Pricing Pressures** The 340B program, which allows hospitals to purchase drugs at discounted prices, is expected to increase in 2026, reducing Amgen’s net prices . Additionally, Medicare price cuts for Enbrel (-48% YoY sales drop in Q4 2025) highlight vulnerability in legacy franchises . To counter this: - Amgen is focusing on premium-priced products like Repatha (cholesterol) and Tezspire (inflammation), which have strong formulary coverage . - The company is also reducing debt ($6B retired in 2025) to maintain financial flexibility . #### **3. Regulatory & Market Risks** - **Regulatory Delays**: The FDA’s ongoing dialogue on TAVNEOS (anti-inflammatory drug) could delay its approval, impacting near-term revenue . - **Market Competition**: Novo Nordisk’s underwhelming 2026 sales forecast for obesity drugs (e.g., Wegovy) and Merck’s PCSK9 inhibitor (Enlicitide) pose threats to Amgen’s MariTide and Repatha franchises . - **Mitigation**: Amgen is accelerating R&D spending ($7.2B in 2025) to advance late-stage assets like MariTide (Phase 3 trials ongoing) and olpasiran (cardiovascular risk reduction) . --- ### **Conclusion** Amgen’s 2026 revenue target hinges on its ability to navigate biosimilar competition, pricing pressures, and regulatory risks. While the company faces headwinds, its diversified pipeline (e.g., MariTide, olpasiran) and strategic initiatives (e.g., debt reduction, direct-to-patient programs) position it well for long-term growth. Investors should closely monitor Phase 3 results for MariTide (Q1 2027) and regulatory updates for TAVNEOS, as these will be critical catalysts for achieving the $37B–$38.4B revenue target. |market_code|code|Ticker|Name|Date|Total Revenue YoY|Total Revenue| |---|---|---|---|---|---|---| |185|AMGN|AMGN.O|Amgen|2025 Q1|9.426614744192293|8.149E9| |185|AMGN|AMGN.O|Amgen|2025 Q2|9.430138292799237|9.179E9| |185|AMGN|AMGN.O|Amgen|2025 Q3|12.395625073503469|9.557E9| |185|AMGN|AMGN.O|Amgen|2025 Q4|8.58463570327977|9.866E9|