) recently announced its preliminary fourth quarter 2012
financial results and its guidance for 2013. The company's total
revenue for 2012 is expected to be around $85.3-$85.7 million,
well below the Zacks Consensus Estimate of $91 million.
The company expects to swing to profitability based on its
efficient cost structureing and top-line growth.
4Q 2012 Snapshot
AMAG's total revenue for the fourth quarter of 2012 is
expected to be within $21.1-$21.5 million, including $14.4-$14.8
million of net Feraheme (ferumoxytol) product revenues in the US,
with higher volume and improved pricing driving year-over year
growth of 14%.
AMAG records revenues mainly from Feraheme, an injectable drug
for intravenous use as iron replacement therapy for the treatment
of iron deficiency anemia (IDA) in adults suffering from chronic
kidney disease (CKD). AMAG is looking to expand Feraheme's label
as a treatment for anemia in adults suffering from IDA with a
history of unsuccessful oral iron therapy.
In December, the company submitted a supplemental new drug
application (sNDA) to the US Food and Drug Administration (FDA)
for the intravenous (IV) dose of Feraheme. The label expansion
may double the market opportunity in the US for the product.
AMAG expects fourth quarter operating expenses to be within
$21.0-$22.5 million, down about 31% from the year-ago period.
AMAG exited 2012 with cash and investments of around $227
2013 Outlook Misses Expectation
AMAG expects to generate total revenues of $73-$77 million in
2013, below the Zacks Consensus Estimate of $78 million. The
company expects Feraheme US sales of $63-$67 million.
AMAG also expects to generate around $10 million as royalties
and product sales related to ex-US sales of Feraheme/Rienso (EU
trade name of Feraheme) and recognition of milestones.
The company expects to incur operating expenses of around
$78-$82 million (research and development expenses of $24-$27
million and selling, general and administrative expenses of
$54-$57 million), down 10% from 2012. The company expects lower
clinical trial costs in 2013 which will be offset by new
investments in a lower-cost production process and pre-launch
investments for the expansion of Feraheme's label.
AMAG expects to exit 2013 with cash and investments of around
We believe that the company's guidance for 2013 is achievable.
We expect investor focus to remain on Feraheme's performance and
the company's efforts to expand the product's label.
We currently have a Neutral recommendation on AMAG. The stock
carries a Zacks #3 Rank (Hold). However, other stocks in the
pharma sector that carry a Zacks #1 Rank (Strong Buy) are
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