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Will 2016 Be Amgen Inc.'s Best Year Yet?

By Sean Williams – Feb 3, 2016 at 10:19AM

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Amgen garnered a half-dozen drug approvals between December 2014 and the end of 2015, and the company delivered record full-year sales and profits in 2015. Could 2016 prove even better?

Image source: Amgen via Flickr.

For shareholders, Amgen's (AMGN -1.32%) 2015 seemed largely forgettable based solely on the movement of its stock. Amgen shares finished the year higher by a meager 2%.

But when it comes to product and pipeline advancements, Amgen had a stellar 2015. Beginning in December 2014 with its approval for Blincyto as a treatment for a rare form of acute lymphoblastic leukemia, and through the end of 2015, Amgen witnessed five total drug approvals and one major label expansion with Kyprolis. Amgen's pipeline progress has many investors wondering whether the company could be on target for its best year yet in 2016. My suggestion is that you can probably count on it.

I believe there are four keys to growth for Amgen in 2016: established products, new product launches, pipeline expansion, and cost-cutting.

Established products
Amgen's easiest source of growth in 2016 is going to be emphasizing its established products. This happens through targeted marketing campaigns, and it also involves potentially passing along price hikes to consumers.

For instance, in the third quarter sales of anti-inflammatory therapy Enbrel surged 30%, partially helped by an 11% boost in inventory from the year-ago-period, but also offset by a 6% drop in units sold due to increasing competition. However, huge price hikes in Enbrel allowed sales of the drug to gallop 30% higher year-over-year, and 8% higher from the sequential second quarter.

The company's Neulasta Onpro kit is another source of potential growth for Amgen. Although we could just as easily file this under "new product launches," Neulasta itself is a mature product for Amgen. By improving the convenience factor regarding the delivery of this white blood cell-enhancing drug for patients undergoing chemotherapy, Amgen can possibly reduce the effects of generic entrants in the coming years and retain its market share. 

New products & product launches
Newly approved products and therapies which are soon to be launched should provide even more growth in 2016. What we're talking about here is the growth potential from new cardiovascular products like Corlanor or Repatha, as well as cancer immunotherapies Blincyto or Imlygic.

Image source: Amgen.

The real allure in 2016 is the growth potential in cardiovascular, which is a completely new therapeutic indication for Amgen. Chronic heart failure drug Corlanor, which is designed to reduce the risk of hospitalization due to worsening heart failure, could really surprise in its first full-year on pharmacy shelves. Wall Street projects Corlanor has peak annual sales potential of $500 million, but I suspect it could be a lot higher.

We also could witness substantial growth from PCSK9 inhibitor Repatha. PCSK9 inhibitors prevent a select protein from binding with receptors on the liver, thus allowing those receptors to filter out LDL-cholesterol, which is the bad kind of cholesterol that can lead to long-term issues. By the second half of 2016 we should get the results of Amgen's cardiovascular outcomes trial for Repatha, and if the results demonstrate superiority over competing therapies, sales of the drug could really take off.

Pipeline expansion
Another growth opportunity for Amgen can be found in label expansion opportunities. For example, Kyprolis winning FDA approval for two new label indications since the summer (including second-line multiple myeloma) should expand its possible pool of multiple myeloma patients. Previously approved as a third-line and higher therapy, Kyprolis demonstrated strong progression-free survival in clinical studies, including a head-to-head trial (ENDEAVOR) against Velcade. 

Image source: Amgen.

The one worry for Kyprolis? Johnson & Johnson's (JNJ -0.71%) and Genmab's Darzalex could be waiting in the wings to eventually take multiple myeloma market share away from Kyprolis. Darzalex is only approved in the third-line and higher setting at present, but Johnson & Johnson's and Genmab's drug delivered an overall response rate of 29% during clinical trials in patients who'd progressed on a median of five prior lines of therapies. In a similar, but not head-to-head study, Kyprolis' response rate was just 23%.

We should also have a decision from the Food and Drug Administration on or before Aug. 24, 2016 on etelcalcetide, which was formerly known as AMG416, for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. A launch of etelcalcetide may not generate a lot of revenue in 2016 if approved, but every little bit of revenue helps.

Finally, Amgen could see its profits improve thanks to its cost-cutting efforts.

In 2014, Amgen announced that it was laying off a cumulative 4,000 workers through two separate cuts, primarily from its research and development operations. The reason Amgen shed nearly 20% of its workforce was in order to reduce labor expenses by around $1 billion annually. These savings aren't immediate, since the cost to launch new products and conduct phase 3 trials is pretty high; the thought process, though, is that as phase 3 trials begin to wrap up, and physicians familiarize themselves with new products (which means less reliance on aggressive marketing), it'll allow Amgen's operating margins to soar.

Amgen has targeted an operating margin of between 52% and 54% by 2018, up from the 38% operating margin it recorded in 2013.

Image source: Pixabay.

Should Amgen be on your radar?
In 2016, according to the consensus from Wall Street, Amgen is expected to bring in $22.3 billion in revenue, amounting to around a 3% increase from the previous year, and $10.67 in EPS, a close to 6% jump. Both figures would mark an all-time high for Amgen, which should be more than enough to get the attention of investors.

However, should that not be enough, Amgen has also delivered five enormous dividend increases of right around 30% over the past five years. After initiating a $0.28 per quarter payout in 2011, Amgen looks to divvy out $1 per quarter in 2016. Its current yield of 2.6% should put it squarely on the radar of income investors.

Considering that 2016 is expected to be another year filled with catalysts, I'd encourage investors looking for growth, value, and/or income, to dig deeper into Amgen.

Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.

The Motley Fool recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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