Amgen Reports Q2 2021 Revenue of $6.53 Billion Driven by Strong Growth in Biosimilars and Key Therapeutics

By | Shibei

On August 3, Amgen announced its second-quarter financial results, reporting total revenue of $6.526 billion (+5%). Total revenue for the first half of the year reached $12.4 billion.

In the second quarter, product revenue increased by 3%, driven by double-digit growth in Prolia (denosumab), Repatha (evolocumab), and the biosimilars MVASI (bevacizumab) and KANJINTI (trastuzumab).

The autoimmune disease treatments Enbrel (etanercept), OTEZLA (apremilast), and the adalimumab biosimilar Amjevita collectively generated $1.785 billion in revenue for Amgen, accounting for 27.4% of total revenue in the second quarter.

The osteoporosis drug Prolia (denosumab) grew by 24% to reach $814 million, remaining one of Amgen’s flagship products. Sales of XGEVA, indicated for bone metastases from solid tumors and giant cell tumor of bone, totaled $488 million. The novel osteoporosis drug EVENITY (an anti-sclerostin monoclonal antibody) grew by 30%, driven by the U.S. market, to reach $131 million.

Q2 revenue for the PCSK9 inhibitor Repatha (evolocumab) was $286 million (+43%). Oncology biosimilars MVASI (bevacizumab) and KANJINTI (trastuzumab) grew by 71% and 27%, respectively, reaching $294 million and $156 million. Bispecific antibody Blincyto (blinatumomab) reached $108 million.

In terms of R&D progress, the KRAS G12C inhibitor Lumakras (sotorasib) received FDA approval ahead of schedule on May 28 and has been included in the NCCN Guidelines. Upcoming plans include:

• Awaiting regulatory review in Japan, the European Union, and other countries;

• Preliminary data on Lumakras in combination with the EGFR monoclonal antibody Vectibix will be presented at the September ESMO Congress;

• NSCLC biomarker and brain metastasis data from the Phase I/II CodeBreaK 100 study will be presented at the September WCLC conference;

• Phase II data for Lumakras monotherapy in colorectal cancer (CRC) have been submitted for publication;

• Evaluate the efficacy of Lumakras in combination with EGFR inhibitors, MEK inhibitors, and SHP-2 inhibitors across multiple Phase Ib combination cohorts;

• The Phase III study of Lumakras vs. docetaxel for KRAS G12C-mutated NSCLC is expected to report results in the first half of 2022;

• Initiate a Phase II study in Q3 in NSCLC patients with KRAS G12C mutations, STK11 mutations, and/or tumor PD-L1 expression ≤ 1%.

Regarding M&A transactions, Amgen acquired TeneoBio on July 27 for $2.5 billion, securing the company's bispecific and multispecific antibodies developed based on its Human Heavy-Chain Antibody platform.

Three products in Teneobio’s pipeline have entered clinical development, including BCMA/CD3, CD19/CD3, and PSMA/CD3 bispecific antibodies. The preclinical pipeline includes FOLR1/CD3 and 5T4/CD3 bispecific antibodies, cytokines, and multiple CAR-T cell therapies.