Amgen ($AMGN), a big R&D spender facing calls for a breakup, is headed for a major referendum on its strategy in 2015 as a slew of its pipeline assets come up for regulatory review or late-stage results.
The Big Biotech is slated to pull off as many as 5 drug approvals--or rejections--on the year, and its performance will either affirm its penchant for moonshot R&D or embolden critics who claim the company spends too much on research. Amgen's R&D budget jumped 5% to $4.3 billion last year, amounting to about 21% of the company's sales.
Amgen's biggest late-stage asset is evolocumab, an LDL cholesterol-lowering drug in a race with partners Sanofi ($SNY) and Regeneron ($REGN). The drug, to be marketed as Repatha, is up for an FDA decision by Aug. 27, about a month after the expected approval of Sanofi and Regeneron's alirocumab. Each treatment blocks the protein PCSK9, which stands in the way of the body's ability to clear "bad" cholesterol from the blood, and analysts expect the antibodies to bring in about $3 billion apiece at their peak.
Then there's brodalumab, an AstraZeneca ($AZN)-partnered anti-inflammatory drug the company expects to submit as a psoriasis treatment this year, while at the same time awaiting late-stage data in asthma. And Amgen this week filed an FDA application to expand the indication for Kyprolis, the cancer treatment at the heart of the company's roughly $10 billion buyout of Onyx Pharmaceuticals.
The company is also expecting final word on two delayed therapies: talimogene laherparepvec for skin cancer and ivabradine for heart failure. The former--T-Vec, for short--is an oncolytic vaccine targeting metastatic melanoma, and, after a three-month delay in its FDA review, Amgen is expecting a yes or no by Oct. 27. Ivabradine, to be marketed as Corlanor, is up for approval by May 28.
If Amgen can run the table, it could go a long way toward silencing critics of its R&D strategy, a chorus that includes hedge fund manager Daniel Loeb and Bernstein analyst Geoffrey Porges. Each has advocated the company split in two, shifting legacy products like Aranesp and Enbrel into a low-spending, high-margin drug company and placing in-development assets like evolocumab and T-Vec in the hands of a more liberally budgeted biotech with a focus on R&D. Amgen "has all the hallmarks of a hidden-value situation," Loeb said at a conference in October, "one of our favorite investment themes."
Amgen has demurred to the suggestion, and, perhaps in response, the company has enacted a broad cost-cutting plan, trimming $300 million from its budget last year and expecting to save $500 million more in 2015. Amgen is laying off about 20% of its staff throughout the year and promising to be more selective with its R&D operation, part of an effort to save up to $1.5 billion by 2018.
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