12. Amgen

Amgen had a good year but sees challenges ahead with potential biosimilar and pricing challenges on key meds.

12. Amgen
Headquarters: Thousand Oaks, California
2016 revenues: $22.99 billion
2015 revenues: $21.66 billion

Amgen generated $22.99 billion in global sales last year. To hear CEO Robert Bradway discuss the year, Amgen made “substantial progress” in 2016 by advancing its pipeline and delivering EPS and revenue growth.

The Big Biotech grew sales 6% in 2016 over 2015 and reported non-GAAP EPS that was up by 12%, Bradway told analysts and investors on the company’s fourth-quarter conference call.

On the biosimilar front, Amgen reeled in an important FDA approval for its version of AbbVie’s megablockbuster Humira, but that launch is expected to be caught up in legal limbo for quite some time. If Amgen were to go forward with an “at-risk” launch, it’d be on the hook for damages if it comes away the loser in a patent dispute.

The company also progressed last year in advancing to market key meds Parsabiv in kidney disease, romosozumab in bone health and Erenumab for migraines, Bradway said. Parsabiv is approved in Europe and Amgen expects an approval “soon” in the U.S., he added.

On the other side of the biosim coin, Amgen recently won a reprieve for its big-selling Enbrel as challenger Sandoz indicated it wouldn’t launch its version of anti-TNF blockbuster Enbrel before 2018 due to a legal fight. Bracing for eventual Enbrel hurt, Amgen inked an “outcomes” contract with Harvard Pilgrim on its key rheumatoid arthritis drug.

But challenge lies in the year ahead for the company, “as declines in our mature brands will begin to offset volume growth from our more recently launched products,” Bradway said on the call. Amgen is anticipating $22.3 billion to $23.1 billion in revenues and non-GAAP EPS between $11.80 and $12.60, figures that both came in below Street estimates.

Analysts at Barclays wrote that the management set “reasonable expectations” for the upcoming year as Amgen is facing potential biosimilar and pricing challenges on key meds Epogen, Neulasta and Enbrel. But the biotech can still can “generate modest EPS growth mainly through operating leverage,” the analysts figure.

Already in 2017, things have been pretty eventful for the biotech. In January, a judge decided that PCKS9 rivals Sanofi and Regeneron would need to halt sales of their Praluent after a jury’s earlier patent decision, handing the market to Amgen and its Repatha. Those companies appealed and won a stay on that decision in February.

Since then, Amgen reported that its drug cut cardiovascular risks in an outcomes trial, with the full data to be released in March.

12. Amgen