Saturday, Dec. 2, is the deadline when the Food and Drug Administration will – under the Prescription Drug User Fee Act (or PDUFA) – review Amgen (AMGN, Financial)'s application for Repatha.
With its application, Amgen in particular is seeking approval to integrate the label of Repatha with the results that came from the FOURIER study.
Repatha is the trade name under which Amgen markets evolocumab, a monoclonal antibody that has been created to treat hyperlipidaemia.
Hyperlipidaemia is a metabolic disorder that manifests itself with an alteration; that is, an increase in some or all types of lipids and/or lipoproteins in the bloodstream.
Results of the FOURIER trial, which were published in spring 2017, led the researchers to conclude that inhibition of PCSK9, a protein that reduces the ability of the liver to get rid of the bad cholesterol from the blood, “with evolocumab on a background of statin therapy lowered LDL cholesterol levels” is associated with a reduced cardiovascular events’ risk.
The findings of the study, adds the scientific publication, “show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets.”
Repatha is one of Amgen’s key products, whose sales increased 122.5% year over year to $89 million in the third quarter. From its portfolio of products, Amgen made sales of $5.453 billion in the quarter, which represented a 1% decline from the comparable of 2016.
A decision from the FDA is expected for Friday, Dec. 1, since the action date falls on Saturday.
Amgen is trading at $169.71 per share on the Nasdaq stock exchange, with a market capitalization of $123.19 billion. It also has a price to book (P/B) ratio of 3.83 versus an industry median of 4.10, a price to earnings (P/E) ratio of 15.33 versus an industry median of 29.02 and a price to sales (P/S) ratio of 5.45 versus an industry median of 11.76.
The forward P/E ratio for Amgen is 13.26 versus an industry median of 24.21 and for full fiscal years 2017 and 2018, analysts forecast an EPS of $12.67 and $12.75.
The company distributes to its shareholders an annual dividend of $4.60 per share – through quarterly payments of $1.15 – for a dividend yield of 2.70%, which is higher than the S&P 500 current dividend yield of 1.85%.
The health care stock gained 16% so far this year. It is trading at a market value, which is 12.60% below the 52-week high price of $191.10 (the 52-week low is $138.83 per share), and nearly at parity with the Peter Lynch Earnings line.
The average target price for Amgen is $190.55 per share and the recommendation rating is 2.4 out of 5.
The stock is down trending since the last three trading months.
Dec. 1, however, may mark a reversal in the trend of Amgen. Year to date it gained 16.07%, underperforming the S&P 500 index by 0.12%.
Disclosure: I have no positions in Amgen.
