Drugmaker Amgen posts 50 pct. increase in 3Q profit on sales jump, but competition looms

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FILE - This Nov. 9, 2014 file photo shows signage outside the Amgen headquarters in Thousand Oaks, Calif. Amgen Inc. on Wednesday, Oct. 28, 2015 reported third-quarter profit of $1.86 billion. (AP Photo/Mark J. Terrill, File)

Amgen trounced Wall Street expectations with a 50 percent jump in third-quarter profit, due to lower expenses and higher sales for nearly all the biologic drugmakers' medicines.

A day after receiving an impressive fourth drug approval in the past year, the maker of injected osteoporosis treatment Prolia on Wednesday raised its 2015 profit forecast and issued an even higher one for 2016.

Its shares rose 69 cents in regular trading, then added $1.53 to $164.20 in after-hours trading.

The world's biggest biotech company and 11th-biggest drugmaker by revenue reported net income of $1.86 billion, or $2.44 per share. Excluding one-time charges, adjusted profit was $2.72 per share, far above the $2.37 expected by analysts.

The Thousand Oaks, California-based company said revenue rose 14 percent to $5.72 billion, partly due to price increases. Analysts expected $5.34 billion.

Some of that revenue will soon be siphoned off. One of Amgen's older drugs, Neupogen, is starting to lose sales to a less-expensive "biosimilar" version, the first approved in the U.S. Biosimilars are near-copies of biologic drugs, which are produced in living cells rather than by mixing chemicals, as pills are made. A second drug, top seller Enbrel, could face biosimilar competition in the middle of next year.

Amgen Inc. has been working to make up for that, with a major restructuring, new drug development and two recent deals aimed at producing future drugs, an acquisition and a partnership with a second company.

In July 2014, Amgen began laying off about 12 percent of its staff and closing two sites to help fund final steps for approvals of those drugs and then their launches. CEO Bob Bradway told analysts on a conference call that Amgen is on track for its target of $1.5 billion in annual cost savings.

On Tuesday, the Food and Drug Administration approved Amgen's Imlygic, a first-of-a-kind drug that uses the herpes virus to infiltrate and destroy deadly skin cancer tumors that cannot be removed surgically.

The others approved since last December include Blincyto, for treating a rare form of leukemia, and Amgen's first two drugs in its new cardiovascular franchise: Corlanor, the first new medication in a dozen years for heart failure, and Repatha, for people with sky-high cholesterol uncontrollable by standard medicines. Amgen also got approval for a kit with an injector that's attached to patients' bodies for Neulasta, a longer-acting version of Neupogen; both prevent infections in patients getting certain cancer drugs.

While total operating expenses declined in the quarter, spending on sales and administration climbed 17 percent to $1.2 billion because of the drug launches. Spending on research and development also rose, by 11 percent to $1.1 billion, partly to cover a big study meant to prove that Repatha prevents heart attacks and strokes.

Repatha, the first in a new class of drugs called PCSK9 inhibitors, was approved based on its effectiveness in reducing cholesterol. It targets people genetically predisposed to extremely high cholesterol and others not helped enough by statin cholesterol drugs such as Lipitor. How widely it will be used is unclear because insurers have balked at its price tag — roughly $14,000 per year.

Sales of Enbrel, for rheumatoid arthritis and other immune disorders, jumped 30 percent to $1.46 billion in the quarter. Sales rose 6 percent for Neulasta, to $1.37 billion, and 4 percent for Aranesp, for anemia. Prolia, featured in TV commercials with actress Blythe Danner, saw sales increase 25 percent to $320 million.

Amgen now has eight drugs selling in the blockbuster range, more than $1 billion per year, but Neupogen will soon drop off that list. Many patients have switched to the improved version, Neulasta. In addition, Novartis AG's generics unit, Sandoz, in September began selling a biosimilar version called Xarxio.

Meanwhile, Amgen is developing its own biosimilar versions of nine drugs made by rivals, including AbbVie Inc.'s immune disorder drug Humira, the world's top seller with nearly $13 billion in annual sales.

Amgen raised its 2015 forecasts for revenue, to a range of $21.4 billion to $21.6 billion, from $21.1 billion to $21.4 billion, and for adjusted earnings per share, to a range of $9.95 to $10.10, from $9.55 to $9.80.

It also said it expects 2016 revenue of $21.7 billion to $22.3 billion and adjusted earnings per share of $10.45 to $10.75.

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