Amgen Reports 7% Revenue Growth in Q4 2020 Driven by Strong Drug Sales

Compiled by Keke

On February 2, Amgen announced its financial results for the fourth quarter of 2020. Total revenue increased by 7% year-over-year to $6.6 billion compared with the fourth quarter of 2019. Global product sales volume grew by 8%, driven by a 13% increase in volume across the entire product portfolio, including Otezla® (apremilast), MVASI® (bevacizumab-awwb, a bevacizumab biosimilar), KANJINTI® (trastuzumab-anns, a trastuzumab biosimilar), and Repatha® (evolocumab). Sales growth was partially offset by declines in sales of mature products due to competitive pressures from biosimilars and generic drugs.

Meanwhile, Amgen announced that its total revenue for the full year 2020 increased by 9% to $25.4 billion, with some sales growth offset by lower net selling prices and the impact of the COVID-19 pandemic.

According to Amgen’s financial reports, sales of multiple drugs grew by double digits in the fourth quarter of 2020 or for the full year:

-EVENITY® (romosozumab-aqqg) fourth-quarter sales increased 6% year over year, with full-year growth of 85%. We expect that our partner Astellas will have largely completed its inventory reduction in Japan in the second half of 2020. Volume-driven growth is expected to remain strong throughout 2021.

- Repatha’s fourth-quarter sales increased by 27% year over year, with full-year sales up 34%; sales volume grew by 49% and 67%, respectively. The 2020 volume growth was partially offset by price declines resulting from inclusion in the U.S. Medicare program, and net selling prices are expected to remain relatively stable in 2021. Repatha remains the global leader in the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor class, addressing a market of millions of high-risk cardiovascular disease patients worldwide.

- Aimovig® (erenumab-aooe) sales increased 6% year-over-year in the fourth quarter, with full-year growth of 24%. Aimovig remains the leader in the preventive calcitonin gene-related peptide (CGRP) segment, accounting for an average share of 46% of total prescriptions (TRx) and 38% of new brand prescriptions (NBRx) in the U.S. during the fourth quarter. The emergence of new patients in this segment was suppressed by the impact of the COVID-19 pandemic. However, supported by robust payer access and recent favorable efficacy and safety data compared with topiramate, Aimovig is well positioned for long-term growth in the preventive setting.

Otezla’s fourth-quarter sales amounted to $617 million, bringing the full-year total to $2.2 billion. In the United States, Otezla’s total prescriptions (TRx) increased by 13% year over year for the full year, while new-to-brand prescriptions (NBRx) continued to recover from the impact of the COVID-19 pandemic. Looking ahead, Otezla still has growth opportunities, including ongoing multi-market expansion and plans to seek new indications in the United States. Amgen expects to submit a supplemental New Drug Application (sNDA) to the U.S. FDA in the first quarter of 2021 for the treatment of mild-to-moderate plaque psoriasis.

- AMGEVITA™ (adalimumab) increased by 45% year-over-year in the fourth quarter, with a full-year growth of 54%. AMGEVITA remains the most prescribed adalimumab biosimilar in Europe. With expansion into other global markets, this sales trend is expected to continue through 2021.

-BLINCYTO® (blinatumomab) sales increased by 29% year-over-year in the fourth quarter and by 21% for the full year, driven by broader utilization in the community hospital setting.

- MVASI recorded fourth-quarter sales of $280 million, bringing full-year sales to $798 million. In the United States, MVASI emerged as the leader in the bevacizumab market during the fourth quarter, capturing an average market share of 48%. Sales volume increased by 21% quarter-over-quarter and 25% year-over-year. In 2021, MVASI is expected to launch in several new markets, driving global volume growth, which will be partially offset by a decline in net selling prices due to intensifying competition.

In addition, multiple Amgen drugs have been affected by market competition from generics, resulting in a significant decline in sales:

KANJINTI recorded fourth-quarter sales of $158 million and full-year sales of $567 million, capturing an average 41% share of the U.S. trastuzumab market in the fourth quarter. However, sales volumes declined quarter over quarter, and this downward trend is expected to continue in 2021 given the number of competitors in the trastuzumab segment.

- Neulasta® (pegfilgrastim) sales decreased by 19% year-over-year in the fourth quarter and by 29% for the full year, driven by declines in net selling price and volume due to intensified biosimilar competition. In the long-acting granulocyte colony-stimulating factor (G-CSF) segment, Neulasta Onpro® remains the preferred choice among physicians and patients, capturing a 54% share of unit volume in the quarter. The recently reported U.S. average selling price declined by 28% year-over-year. The decline in both price and volume is expected to persist in 2021 as biosimilar competition intensifies.

- NEUPOGEN® (filgrastim) sales decreased by 26% year-over-year in the fourth quarter, with a 15% decline for the full year.

-EPOGEN® (epoetin alfa) fourth-quarter sales decreased 37% year over year, with a 31% decline for the full year.

-Aranesp® (darbepoetin alfa) sales decreased by 12% year-over-year in the fourth quarter, with a 9% decline for the full year.

-Sensipar/Mimpara® (cinacalcet) sales decreased by 58% year-over-year in the fourth quarter, with a full-year decline of 48%.

Meanwhile, we should also note that Amgen has halted research on a series of cancer treatment candidates, including due to safety concerns with a flagship drug, and discontinued several other drugs during a pipeline restructuring.

The most closely watched candidate is AMG 701 (pavurutamab), a half-life–extended bispecific T-cell engager (BiTE) monoclonal antibody targeting B-cell maturation antigen (BCMA), for the treatment of relapsed or refractory multiple myeloma. This program is regarded as the “successor” to AMG 420. Both drugs have greatly disappointed analysts, who had consistently expressed skepticism about the trial data. Amgen stated, “We have paused enrollment in the Phase 1 clinical study while we discuss protocol amendments with the U.S. FDA to optimize safety monitoring and mitigation measures. Patients currently enrolled who are deriving benefit may continue to receive the investigational drug, and the company expects to resume patient enrollment in the first half of 2021.”

Michael Yee of Jefferies, a prominent Wall Street investment bank, believes that the trial pause was caused by cytokine release syndrome.

Several other candidates with clinical development red flags include:

- AMG 673, a CD33-targeted BiTE drug for acute myeloid leukemia, has had its clinical trials "paused," as Amgen sees greater advantage in its counterpart, AMG 330.

- AMG 596, an epidermal growth factor receptor variant III (EGFRvIII)–targeted therapy for glioblastoma, was discontinued due to R&D prioritization, and development of this candidate now appears to have been completely terminated.

- AMG 397, an oral inhibitor of the anti-apoptotic protein MCL-1, has had its Phase 1 study discontinued, and the research team has shifted focus to the intravenous formulation of the MCL-1 inhibitor AMG 176. AMG 176 is currently in Phase 1 clinical trials for the treatment of hematologic malignancies.

- Additionally, the Phase 3 study of Imlygic in combination with Keytruda for the treatment of melanoma was halted, and the development of this treatment regimen was discontinued due to lack of efficacy.

It is evident that Amgen’s R&D team has devoted substantial effort to its oncology BiTE drug pipeline, aiming to develop novel agents that combine antibodies with T cells to kill cancer cells. One of the most advanced candidates is AMG 757, a half-life extended BiTE molecule targeting delta-like ligand 3 (DLL3) for relapsed or refractory small cell lung cancer. Dose-escalation data were announced in October 2020, and Amgen expects to advance this drug into expansion cohort studies in the coming months.

Reference Source:

1.Amgen Reports Fourth Quarter And Full Year 2020 Financial Results

2.Amgen scraps or halts a slate of 5 cancer studies in a series of setbacks raising fresh doubts about its BiTE plans