安进

Novartis and Ionis announced on Sept. 4 that the Lp(a)Horizon phase 3 trial for cardiovascular drug candidate pelacarsen did not reduce the combined risk of four key cardiovascular events in patients with cardiovascular disease and high levels of biomarker Lp(a). Amgen shares fell 10% on Sept. 8.

Why it matters: Amgen's own drug candidate olpasiran also prevents the production of Lp(a) and is in a similar phase 3 cardiovascular outcomes study. Pelacarsen's failure concerns investors who have watched Amgen's late-stage pipeline narrow in recent months. Following the failure of phase 3 gastric cancer drug bemarituzumab and Amgen's decision to return rights to the atopic dermatitis drug rocatinlimab to Kyowa Kirin, Amgen's late-stage pipeline value has centered on cardiometabolic indications for olpasiran and diabetes/obesity therapy maritide. We're surprised by the failure of the pelacarsen trial, but we think several differences across these programs make extrapolation difficult. For example, olpasiran's more potent 95% Lp(a) reductions in phase 2 and Amgen's focus on patients with higher Lp(a) levels could be differentiating factors.

The bottom line: We're maintaining our $342 fair value estimate for wide-moat Amgen following the disappointing pelacarsen announcement. After the 10% share price decline, we think Amgen shares remain slightly overvalued, trading at roughly a 15% premium to our fair value estimate. We still assign a 50% probability of approval to olpasiran in 2028, which we think appropriately accounts for the novelty of the Lp(a) mechanism of action, as well as both clinical trial and molecule differences from pelacarsen. Olpasiran is still the second-largest pipeline opportunity, in probability-adjusted sales, in our 10-year Amgen sales forecast, at $2.4 billion in 2035 sales. This is well behind Maritide ($8.5 billion in 2035 sales), which should have phase 3 data in 2027 and could have a differentiated obesity profile.

For more information on Amgen's portfolio and pipeline, please see our recent in-depth report, 'Biopharma Product Pipelines Rise to Meet Steeper Patent Cliffs.'

We're maintaining our fair value estimate at $342 per share.

We assume a 60% probability of maritide's approval and probability-adjusted sales of $8.5 billion in 2035, largely in obesity. We see Prolia's patent expiration in 2025 as the firm's biggest patent cliff this decade, with additional pressure from Otezla generics (likely in 2028) and Repatha biosimilars (2030).

The Horizon acquisition is relatively neutral to our valuation, but it brings a portfolio of rare-disease and immunology drugs that we expect could see combined sales of nearly $8 billion by 2030.

For the Inflation Reduction Act, we assume Medicare negotiations could reduce sales of Otezla and Repatha prior to patent expirations.

We see Amgen's biosimilar portfolio growing to more than $5 billion in sales by the end of our 10-year explicit forecast period. We include $2 billion in peak Imdelltra sales and $4 billion in peak Tezspire sales. Beyond these products, we only model billion-dollar sales for maridebart cafraglutide and two other pipeline products: cardiology drug olpasiran (partnered with Arrowhead) and prostate cancer drug xaluritamig.

We assume a 17% tax rate for Amgen in the long run, higher than the company's recent tax rates, which we believe covers some of the risk from ongoing tax disputes with the IRS.

Under our updated discount-rate framework, we've raised our Amgen WACC estimate to 7.1% from 6.9%. Our beta of 0.6 reflects our view of both biopharma's defensive nature and Amgen's own fundamentals and market returns. The change does not reflect a new view of the business, but a more granular expression of our existing risk assessment.

Amgen markets several blockbuster biologic therapies in oncology and immunology, giving it the intangible assets that form the foundation of its wide moat. We think the firm does face environmental, social, and governance risks, particularly related to potential US drug price-related policy reform (Amgen sees roughly three-fourths of its sales from the US market) and ongoing potential for product governance issues (including litigation). While we have factored these threats into our analysis, we don't see them as material to our valuation or moat rating. Highly profitable biologics like Repatha and Tezspire continue to support very strong free cash flows for the firm, generally above 30% of sales. We expect Amgen to see relatively steady free cash flow margins, and returns on invested capital should remain above its cost of capital for the foreseeable future. We think newly launched products and higher rates of productivity for its late-stage pipeline—both branded and biosimilar—will allow the firm to maintain strong ROICs. With new lower-cost manufacturing technology and aggressive cost-cutting efforts, pricing and volume pressure from biosimilar competition should not weigh heavily on long-term margins.

One of the original biotechs, Amgen launched innovative recombinant proteins for anemia and neutropenia, beginning with Epogen in 1989 and Neupogen in 1991. Longer-acting products Aranesp and Neulasta were launched in 2001-02, just as the firm decided to acquire Immunex and bring immunology drug Enbrel into its portfolio. The launch of bone-strengthening drug Prolia/Xgeva in 2010 led to $6.6 billion in 2024 sales prior to biosimilar competition in 2025.

Amgen has largely continued to grow despite steady regulatory and competitive headwinds, including safety issues weighing on anemia drugs Epogen and Aranesp since 2007, as well as generic (biosimilar) competition in anemia and neutropenia (against Epogen, Neupogen, and Neulasta). Prolia/Xgeva was Amgen's single-largest product at roughly 18% of sales in 2025. However, biosimilars to Prolia/Xgeva entered in 2025, and Otezla generics are likely coming in 2028. Repatha biosimilars standing as the next big threat to growth (2030), but we expect steady sales growth for the cholesterol-lowering therapy until then, due to strong reimbursement and excellent cardiovascular outcomes data for a broad range of patients with cardiovascular risk factors.

Several newer products continue to bolster Amgen's moat. Newer products like immunology drugs Tezspire and Uplizna and osteoporosis drug Evenity are poised to be top products by 2030. Evenity was approved in 2019, and while cardiovascular side effects could limit broad uptake, the drug's bone-forming mechanism of action complements Amgen's Prolia. Tezspire is a differentiated therapy for severe asthma patients, and Uplizna's prescribing label is expanding to include more rare immune conditions.

In addition, Amgen's own biosimilar portfolio is growing, as it has launched against Roche's and AbbVie's mature oncology and immunology franchises and looks ready to be a key participant in biosimilar immuno-oncology drug launches (including Bristol's Opdivo and Merck's Keytruda). We think Amgen's experience navigating regulatory, clinical, and manufacturing hurdles, as well as its strong reputation for its branded therapies, is helping the firm position itself as a leading biosimilar player.

Regarding pipeline productivity, we think Amgen has turned a corner, and we think it will be able to maintain its top line, despite pressure on current blockbusters. Recently launched lung cancer drug Imdelltra and promising phase 3 cardiometabolic drug candidates like olpasiran (cardiovascular disease) and maridebart cafraglutide (obesity and diabetes) stand out as the biggest drivers in our model. Beyond Imdelltra, Amgen is beginning to amass a pipeline of oncology therapies, with heavy investment in bispecific therapies that could more effectively harness the immune system to fight specific forms of cancer. However, this pipeline is still relatively early and has seen mixed data, and we therefore incorporate moderate sales into our valuation model from these pipeline candidates.

Amgen's pipeline had been stale since the launch of Prolia/Xgeva, but cholesterol drug Repatha revived our enthusiasm for the firm's research engine. Blincyto and Tezspire also look differentiated.

The acquisition of Decode gave Amgen the ability to identify potential new drug targets, validated by human genetics, and the firm continues to build on this database.

Amgen's improved manufacturing efficiency not only will benefit gross margins but also could give the firm a cost advantage in the biosimilar market.

Biosimilars have been on the market in Europe since 2007 but have had a larger impact on Amgen since 2019 as US exposure intensifies. Pressure on Prolia/Xgeva intensified in 2026.

Amgen's position in blood cancer is uncertain, as Kyprolis sales haven't lived up to expectations from the $10 billion Onyx acquisition, and Johnson & Johnson/Genmab's Darzalex and BCMA-targeted therapies are strong competition.

Amgen lacks the focus of some of its biotech peers, with drugs targeting large markets like osteoporosis and cardiology and specialty markets like immunology and oncology.