Company Reports

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.

Biopharma firm Amgen has its roots in providing supportive-care products to kidney disease and cancer patients, but it has expanded its portfolio to include innovative drugs in therapeutic areas ranging from cardiology to immunology. Despite headwinds from biosimilar and branded competition, Amgen's newer blockbusters like cholesterol-lowering drug Repatha defend its wide moat and keep free cash flow above 30% of sales in our forecast.

Amgen's revenue grew 10% in the second quarter, and non-GAAP earnings per share grew 4%. Management raised the midpoint of its 2026 revenue guidance by $1 billion to $38.8 billion and raised the non-GAAP EPS guidance midpoint by $0.50 to $22.90.

Amgen reported 6% revenue growth and 5% non-GAAP earnings per share growth in the first quarter. Management nudged its full-year guidance up to $37.1 billion-$38.5 billion in revenue and $21.70-$23.10 in non-GAAP EPS. The shares fell 5% in early trading on May 1.

Amgen reported 10% revenue and non-GAAP earnings per share growth for 2025. Guidance for 2026 implies 1%-4% top-line growth and 2% non-GAAP EPS growth at the $22.30 midpoint. The shares were relatively flat after hours on Feb. 3.

Amgen has its roots in providing supportive-care products to kidney disease and cancer patients, but it has expanded its portfolio to include innovative drugs in therapeutic areas ranging from cardiology to immunology. Despite headwinds from biosimilar and branded competition, Amgen's newer blockbusters like cholesterol-lowering drug Repatha defend its wide moat and keep free cash flow above 30% of sales in our forecast.

The Trump administration and several biopharma firms announced new drug pricing agreements on Dec. 19. While previous deals included US drug firms Pfizer (Sept. 30) and Eli Lilly (Nov. 6), the nine new deals included additional US firms Amgen, Bristol Myers Squibb, Gilead, and Merck.

Amgen reported 12% revenue growth driven by double-digit growth from 16 products, but higher operating expenses and a higher tax rate drove a smaller 1% increase to non-GAAP EPS. Management slightly raised 2025 top-line and bottom-line guidance.

Amgen reported 9% revenue growth and 21% non-GAAP EPS growth in the second quarter. Management raised its 2025 revenue guidance by $500 million at the midpoint to $35 billion-$36 billion and increased non-GAAP EPS by $0.15 at the midpoint to $20.20-$21.30.

Amgen announced detailed tolerability data from phase 1 and phase 2 studies of obesity drug candidate maritide, and management disclosed the design of its two ongoing phase 3 obesity studies.

Amgen reported 9% top-line growth and 24% non-GAAP EPS growth in the first quarter, and management maintained full-year guidance for mid-single-digit growth in each measure, at the midpoint.

Amgen reported $33.4 billion in revenue (19% growth, boosted by the Horizon acquisition) and $19.84 in non-GAAP earnings per share (6% growth) for 2024. 2025 guidance implies roughly 3%-7% top-line growth and 1%-7% non-GAAP EPS growth.

Amgen has its roots in providing supportive-care products to kidney disease and cancer patients, but it has expanded its portfolio to include innovative drugs in therapeutic areas ranging from cardiology to immunology. Despite headwinds from biosimilar and branded competition, Amgen's newer blockbusters like cholesterol-lowering drug Repatha defend its wide moat and keep free cash flow above 30% of sales in our forecast.

Following President-elect Donald Trump’s Nov. 14 announcement of the nomination of Robert F. Kennedy Jr. as secretary of the US Department of Health and Human Services, there have seen several more nominations for leadership in the 13 HHS divisions, including Dr. Mehmet Oz (Centers for Medicare and Medicaid Services) on Nov. 19, Dr. Marty Makary (US Food and Drug Administration) and Dr. Dave Weldon (Centers for Disease Control and Prevention) on Nov. 22, and Dr. Jay Bhattacharya (National Institutes of Health) on Nov. 26. Overall, we think these selections show a consistent theme of introducing potential disruptive forces to US healthcare, although their lack of experience and the power of career staffers in these agencies could serve to blunt any significant proposed changes. We continue to see obesity drugs and vaccines as areas of potential scrutiny, although without any clarity on proposals, we’re not making any changes to our fair value estimates following these announcements.

We think Amgen’s phase 2 data for obesity drug candidate maritide shows evidence of a differentiated convenience profile (monthly or less frequent injections versus weekly injections for approved therapies) as well as potential for a reliable manufacturing foundation, given Amgen’s biologics manufacturing record and fewer injections needed per patient. In addition, data on bone mineral density and heart rate effects was reassuring and supports the safety profile of the drug candidate. However, the view on efficacy is somewhat muddled by pooled data and lack of clarity on doses moving to phase 3; we think it looked only in line with approved competitors. In addition, Amgen is still trying to reduce nausea and vomiting side effects by starting patients at even lower doses.

President-elect Donald Trump announced on Nov. 14 that he is nominating Robert F. Kennedy Jr. to be secretary of the Department of Health and Human Services under his new administration in 2025. RFK Jr. has strong views on public health and, if confirmed, could use his position to make changes at several of the 13 HHS divisions. In our Nov. 8 note, we discussed the potential tailwinds of a Trump administration, including possible repeal of the Medicare negotiation provision in the Inflation Reduction Act, less Federal Trade Commission scrutiny of acquisitions, and a likely continuation of lower corporate taxes. However, if RFK’s nomination is confirmed, we expect more “wild card” headwinds to the industry will come to fruition. As the HHS covers the US Food and Drug Administration and the Centers for Disease Control and Prevention, an HHS secretary skeptical of vaccine and obesity drug benefits could work to erode public trust, put up roadblocks for approval of new vaccines, and prevent the CDC from recommending any vaccines that make it through the approval process. With less federal guidance, we think it is possible certain states could waver in support of broad mandates for childhood vaccines. All of these could weigh on sales of vaccines in the US, including covid vaccine makers Moderna and BioNTech and big biopharma vaccine makers like GSK (we model 14% of GSK revenue from US vaccine sales in 2024), Pfizer (12%), Merck (9%), and Sanofi (6%).

We think that President-elect Donald Trump brings a mix of potential headwinds and tailwinds to the biopharma industry, and we’re not making any adjustments to our fair value estimates at this time. We had previously assumed that the most likely case was split control of the presidency and Congress by Democrats and Republicans. However, with Republicans locking in control of the Senate and holding a lead in elections in the House, we think it looks increasingly likely that Trump and his party could have control across both branches of government, making any potential policy priorities more likely to be implemented.

Amgen’s third-quarter product sales grew 24% (or 8% excluding the October 2023 Horizon Therapeutics acquisition), with strong double-digit growth for key products including cholesterol-lowering drug Repatha (40% growth), leukemia drug Blincyto (49%), osteoporosis drug Evenity (30%), and asthma drug Tezspire (67%). Management raised its top-line guidance for 2024 by $100 million at the midpoint to $33 billion-$33.8 billion and narrowed its non-GAAP earnings per share guidance to $19.20-$20.00.

We’re maintaining our $317 fair value estimate for Amgen following solid second-quarter results. Management slightly narrowed its top- and bottom-line guidance for the full year, but we’re not making any significant changes to our forecast. Amgen saw strong double-digit growth for key long-term growth drivers like osteoporosis drug Evenity, cholesterol-lowering drug Repatha, asthma drug Tezspire, and leukemia drug Blincyto. All of these drugs are seeing demand growth, with Tezspire holding the potential to expand into other immunology indications (like chronic obstructive pulmonary disease) and Blincyto expanding to newly diagnosed patients.

Amgen’s first-quarter product sales grew 22%, or 6% excluding the October 2023 acquisition of rare-disease firm Horizon Therapeutics, slightly ahead of our expectations. Management narrowed its top- and bottom-line guidance for the full year. In conjunction with earnings, Amgen announced that it has completed an interim analysis of a phase 2 trial of obesity drug candidate maritide (AMG 133). Although Amgen did not disclose many details, management was encouraged enough to announce that the program will move to phase 3 in obesity, obesity-related indications, and diabetes, an area where theoretical concerns about blood sugar effects of the drug had previously made development less appealing. We think the most likely scenario is that interim data showed manageable tolerability, solid safety, efficacy that rivals the top drug candidates in development (around 25% weight loss), and a differentiated dosing profile (monthly or perhaps quarterly dosing).