As it’s customary with Amgen, Inc. (NASDAQ:AMGN), the biotech giant topped analysts’ expectation in each of the first three quarters of 2016. Chances are that it’ll top expectations once more when it reports its fourth-quarter and full-year 2016 figures on Feb. 2. So if you’re following AMGN stock, you don’t need to worry about Amgen’s profits.
Instead, you’ll want to watch the following items Thursday when Amgen reports its fourth-quarter results:
#1: Enbrel Sales Trend
Compared to the third quarter of 2015, Amgen reported flat product sales in Q3 2016. This was mostly due to its top-selling drug, Enbrel, losing ground. Sales for the drug had increased 24% in Q1 and 10% in Q2, but in the third quarter, total Enbrel sales were $1.452 billion, versus $1.459 billion in the year-ago period.
The problem doesn’t seem to be seasonal fluctuation, considering that Enbrel sales grew by 30% in Q3 2015, compared to Q3 2014.
The problem is that competition is catching up. Amgen usually says, “offset partially by the impact of competition” when giving details about Enbrel sales. However, in Q3 2016, “partially” was conspicuously absent. Did someone just forget to copy-and-paste? Maybe. Maybe not.
AMGN stock holders should pay attention to see if Enbrel will resume growth through increased volume, as opposed to price hike.
Enbrel faces three major growth barriers.
- First, it competes against AbbVie Inc’s (NYSE:ABBV) Humira and Johnson & Johnson’s Remicade. This leads to the second challenge.
- Stiff competition necessitates incremental rebates to payers to maintain its formulary position.
- The third challenge is the biosimilar availability. For instance, the FDA has approved Erelzi, an Enbrel biosimilar by Novartis AG (ADR) (NYSE:NVS).
Put simply, further lackluster Enbrel growth would weigh on AMGN stock.
#2: Amgen’s Drug Pricing
Investors also should look closely at how fast Amgen is hiking prices.
I raised concerns about Amgen stock growing sales by increasing drug prices, instead of higher volumes, after the company reported its Q2 2015 earnings. Almost two years on, the trend of growing sales with price hikes is still commonplace at AMGN.
From a business perspective, it’s smart to try to squeeze out every possible dollar from your inventions. However, the U.S. government is standing up against it. President Donald Trump told drugmakers in a Jan. 31 meeting that “we have to get the prices down.”
This won’t be good for the top and bottom lines of any drugmaker. However, for a company who thrives on hiking drug prices like AMGN, the downside gets bigger.
#3: How Did Repatha Perform?
Repatha is heralded as potentially one of Amgen’s best sellers. The company said the drug caters to “serious diseases with significant unmet needs.” However, it brought in a meager $40 million in Q3.
One barrier to market growth is that payers have employed utilization-management procedures, which limited patients’ ability to gain access to Repatha. Execs said during Q3 earnings call that they’re working with payers and providers to allow unlabeled patient access. Investors should look to see if collaborations with payers and providers are yielding significant Repatha growth.
The drug, which currently competes with Sanofi SA (ADR) (NYSE:SNY) and Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Praluent, had a 55% share of new-to-brand prescriptions (NBRx) in Q4, according to an Amgen presentation at this year’s JPMorgan Healthcare Conference. Still, AMGN stock holders probably want to know just how much in sales that amounted to.
But it has to be noted that an ongoing court case that Amgen filed against Sanofi and Regeneron on patent infringement grounds is tipping the scale in Rapatha’s favor for now.
Finally, investors should pay attention to see if low expenses is continuing and will continue at Amgen. Since the beginning of 2015, AMGN has reduced its total expenses by roughly 3.7% to 13.22%. Keeping expenses low will be critical to future profitability, especially in Trump’s recent focus on drugmakers.
Earnings apart, I believe the uncertainties surrounding the future make AMGN stock less attractive.
As of this writing, Craig Adeyanju did not hold a position in any of the aforementioned securities.