* To launch biosimilars of 6 blockbuster drugs from 2017
* Sees 2013 adjusted EPS $7.05 to $7.35
* Shares down 1.1 pct
By Bill Berkrot
NEW YORK, Feb 7 Amgen Inc said it
expects generic versions of biotech drugs, known as biosimilars,
to be a multibillion-dollar opportunity for the company and has
targeted some of the industry's biggest sellers, including the
main rivals for its own blockbuster rheumatoid arthritis drug
The company on Thursday also said that between this year and
2016 it will have key late-stage data from eight experimental
Amgen Chief Executive Robert Bradway, at a meeting in New
York to update analysts and investors on business strategy, said
the company plans to launch six biosimilars beginning in 2017 -
four cancer drugs and the two Enbrel rivals - Abbvie's
Humira and Remicade, which is sold by Johnson & Johnson
and Merck & Co Inc.
It also plans to launch biosimilar versions of Roche Holding
AG's multibillion-dollar cancer drugs Avastin,
Herceptin and Rituxan, as well as Eli Lilly and Co's
"They went after six of the largest biologics in the market
with a total of over $40 billion in revenue. But they laid out
this big goal without a lot of specifics," said RBC Capital
Markets analyst Michael Yee, who is looking for details on
pricing and the types of studies the company will conduct to
bring its biosimilars to market.
"Certainly biosimilars are an important driver to 2017 and
beyond, but we'd like more specifics."
The world's largest biotechnology company believes it has a
unique capability to become a major player in biosimilars once
U.S. health regulators finalize the approval pathway for such
drugs, which are not identical matches of the branded medicines
in the manner of traditional generic versions of pills.
"The company is clearly straddling two business
opportunities that sometimes seem in conflict with each other -
a defender of the innovative products and a participant in
biosimilar products. That tension is going to continue to be
difficult for them to manage," said Sanford Bernstein analyst
Amgen research chief Sean Harper said the company was
viewing biosimilars as more of a global opportunity. "We feel
that these medicines are very valuable and in many parts of the
world patients have no access to them because they are so
expensive," he said.
Enbrel, which had 2012 sales of $4.2 billion and has patent
protection into 2028, will become more profitable at the end of
the year, when a profit-sharing arrangement with Pfizer
becomes a royalty payment. That will result in an operating
profit of about $800 million in 2014, the company said.
Amgen raised its 2013 earnings forecast to account for a tax
credit due to federal settlements for prior years. Amgen now
expects adjusted 2013 earnings of $7.05 to $7.35 per share, and
said it would record the credit in the first quarter.
The company last month forecast earnings per share of $6.85
to $7.15. The 2013 revenue forecast remains unchanged at $17.8
billion to $18.2 billion.
Chief Financial Officer Jonathan Peacock said Amgen will
continue to return more than 60 percent of adjusted net profit
to shareholders through dividend increases and some share
The company also said it plans to continue to pursue
strategic acquisitions, and that it expects to expand its
business into major Asian markets in 2015 and 2016. "The fact
that Amgen was not present in Japan and China was a noticeable
gap," Bradway said.
"They are a bellwether for the industry," Bernstein's Porges
said of Amgen. "The real focus is getting into lower-priced
markets and lower-priced products and driving business through
cost efficiencies. That tells you something about the state of
Harper provided an update of the company's drugs in
development in several therapeutic areas, including medicines
for a variety of cancers, heart disease, osteoporosis and
The cancer drugs include trebananib for ovarian cancer with
key late-stage data expected in mid-2013, and rilotumumab for
advanced gastric cancer, a huge unmet need in China and emerging
markets. Late-stage data on that drug is due in 2016, just about
the time the company sees making a move into China.
Amgen's highest-profile drug in development is AMG-145, its
cholesterol fighter from a closely watched new class of
medicines called PCSK9 inhibitors meant to be taken by patients
unable to tolerate statins, like Lipitor and Zocor, or those who
fail to reach LDL goals with statins. In earlier clinical
trials, PCSK9 inhibitors have dramatically reduced bad LDL
The class, which blocks a protein that prevents the body
from removing artery-clogging LDL cholesterol from the
bloodstream, is a hot area of research being pursued by several
companies, including Regeneron Pharmaceuticals Inc in
partnership with Sanofi SA, and Pfizer.
Amgen has begun a Phase III AMG-145 program with more than
26,000 patients over seven studies. It expects to have initial
Phase III data in early 2014, and estimates having results in
2018 from a large so-called outcomes study to demonstrate that
it can reduce heart attacks and strokes.
Harper said he was confident that AMG-145 would show "a
decrease in cardiovascular outcomes". He added: "This will be
the biggest study Amgen has ever done."
He expressed similar confidence that romosozumab for
post-menopausal osteoporosis would prevent fractures in a pair
of late-stage trials of about 6,000 women, with data expected in
Tony Hooper, Amgen's head of global commercial operations,
said AMG-145 would compete in a market estimated to be 17
million high-risk patients.
Amgen shares were off 96 cents, or 1.1 percent, at $85.63 on
Nasdaq, on a generally down day for the broader market.