TRENTON, N.J. (AP) -- Amgen Inc., the world's largest biotech company, will discuss drugs in development and growth prospects when it reports its fourth-quarter results after the stock market closes Thursday.
WHAT TO WATCH FOR: The maker of biologic drugs for cancer and blood disorders will give its first 2012 financial forecast. Executives likely will focus on what will drive growth this year.
President and Chief Operating Officer Robert Bradway told analysts at a conference on Jan. 9 that revenue growth will accelerate this year. Bradway will become the fourth CEO of the Thousand Oaks, Calif.-based company when Kevin Sharer steps down in May.
The maker of Neulasta, for reducing infections in chemotherapy patients, has had just one blockbuster medicine approved in the last couple years, denosumab. The bone-building drug is marketed as Prolia, for treating osteoporosis in women, and in a different dosage as Xgeva, for preventing bone fractures in patients whose cancer has spread to bones.
Now Xgeva is awaiting U.S. approval for preventing prostate cancer from spreading to bones. New study data for that is to be presented soon at a medical conference, advisers to the Food and Drug Administration will review the drug at a Feb. 8 meeting, and the FDA is rule by April 26.
Amgen raised its profit forecast for 2011 to $5.15 to $5.30 per share in October, shortly after saying it was laying off nearly 6 percent of its research and development staff to free up money for expensive, late-stage patient testing of experimental drugs. The company expects to release data on six late-stage drug studies over the next five years.
It's been trying to keep investors happy with a $5 billion share buyback in December and last fall's initiation of dividend payments. Those are long standard for the big pharmaceutical companies with which Amgen competes, and help make slow-growing health stocks more attractive.
Analysts may ask about rumors Amgen is considering buying fellow biotech company Biogen Idec, which has better near-term prospects for growth and products focusing on a different area, neurological disorders.
WHY IT MATTERS: Amgen, ranked 13th among drugmakers by 2010 sales, is seen as needing more new products or partners to speed up growth, but analysts don't expect major changes until the CEO transition.
Meanwhile, the FDA is expected early this year to release the first guidelines spelling out the research and other steps needed for drugmakers to get approval for the first "biosimilars," which would be akin to generic versions of biologic drugs.
Until now, the U.S. hasn't allowed such follow-on biologics because of the complexity of these drugs, which are "manufactured" in living cells, not made by mixing chemicals together. Given their huge price tag — up to $100,000 for a course of treatment — the Obama administration's health care overhaul included allowing biosimilars as a way to hold down health spending.
Amgen recently announced a partnership with a major generic drugmaker, Watson Pharmaceuticals Inc., to develop biosimilar versions of biotech drugs. But rival Novartis AG, the world's second-biggest drug company, last week said it is in late-stage testing of biosimilar versions of two of Amgen's big sellers, Neulasta and Neupogen, for treating a decline of infection-fighting white blood cells caused by cancer and other disorders.
Analysts think biosimilar versions of two other Amgen blockbusters also could hit the market in two or three years, and that could slice off much of the company's revenue.
Meanwhile, its blockbuster anemia drugs Aranesp and Epogen, covered in large part by Medicare and Medicaid, have had limits put on reimbursements due to concerns about safety at high doses. Those limits, and some newer competition, have been cutting revenue, but Amgen has been locking in long-term contracts with providers. The two drugs had about $5 billion in sales in 2010, just over a third of total revenue.
WHAT'S EXPECTED: Analysts polled by FactSet, on average, expect earnings per share of $1.22 and sales of $3.92 billion.
LAST YEAR'S QUARTER: A year ago, Amgen reported profit of $1.08 per share on revenue of $3.84 billion.
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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma
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