Dive Brief:
- Amgen saw its stock rise Friday morning after reporting better-than-expected earnings for the fourth quarter, as well as positive topline results from a closely watched cardiovascular outcomes study for its PCSK9 drug Repatha (evolucumab).
- The cholesterol-lowering drug significantly reduced the risk of cardiovascular events in the four-year FOURIER study, Amgen said, potentially giving the still struggling drug a major lift.
- While the trial success is good news for Amgen, markets will likely want to see detailed data measuring the magnitude of the positive treatment effect before revising sales forecasts. Amgen plans to unveil that information at the American College of Cardiology conference in March.
Dive Insight:
Overall, Amgen beat consensus estimates for the fourth quarter amid higher product sales. Quarterly revenue was just under $6 billion, up 8% from the same period a year prior, mainly driven by higher sales of Enbrel (etanercept), Prolia (denosumab) and Kyprolis (carfilzomib), as well as Repatha.
CEO Robert Bradway said Amgen finished 2016 strong, pointing to the cardiovascular outcomes data as an important domino to help drive long-term growth.
"In terms of efficacy, the [Repatha] trial met its primary composite and secondary composite endpoints, and importantly in terms of safety, there were no new findings in the trial," Bradway said during the earnings call.
"This is obviously an important result for us and for the field as it clearly validates the outcomes benefit of PCSK9 inhibition in cardiovascular disease."
The study evaluated whether Repatha reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease. The drug, which has struggled to gain sales, met its primary composite endpoint (time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or coronary revascularization).
Analysts at Jefferies said they view individual endpoints, such as time to cardiovascular death, as important in determining the drug’s value.
Amgen has been battling rivals Sanofi and Regeneron, who market a competing PCSK9 drug called Praluent (alirocumab), in court, recently winning a surprise injunction on sales of Praluent in the U.S. Sanofi and Regeneron are appealing that verdict.
The positive FOURIER data, plus the injunction, could give Repatha the edge it needs to both beat out its competitor and win over payers, who have balked at the drug's cost.
Amgen also expects its biosimilars portfolio will be a long-term growth driver, Bradway said. The big biotech recently won U.S. approval for a copycat version of AbbVie's Humira (adalimumab), although patent litigation will likely keep the drug off the market for some time.
But Amgen is also vulnerable to biosimilar competition itself.
For 2017, Amgen said it expects flat revenue, partly due to the continued impact of competition against oncology drugs Neupogen and Epogen as well as biosimilar threats to flagging mainstay Neulasta.
Novartis markets a biosimilar version of Neupogen and recently won approval of — but hasn't launched — a copy of Amgen's main breadwinner Enbrel (etanercept).
The company expects competition to result in "limited net selling price yield through 2017," in particular for Enbrel, management said.
Jefferies analysts said they expect declining sales from Amgen’s legacy products to be largely offset by new products, though, such as Repatha, Prolia and biosimilars.