) reported a third-quarter 2013 loss of 18 cents per share,
narrower than the Zacks Consensus Estimate of a loss of 28 cents
per share but wider than the year-ago loss of 6 cents.
Revenues came in at $60 million, in-line with the Zacks
Consensus Estimate but below the year-ago revenues of $64.8
The Quarter in Detail
Xtandi delivered U.S. net sales of $108.5 million (reported by
)) in the third quarter, up 32% sequentially. The company
estimates that demand accounted for about 50% of this increase
with higher inventory levels at the distribution level accounting
for 25% of the increase. Awareness about Xtandi among oncologists
and urologists continues to be high. Ex-U.S. net sales were $13
Medivation's third quarter collaboration revenue was $60
million consisting of U.S. collaboration revenues of $54.2
million, ex-U.S. collaboration revenues of $1.6 million and
up-front and development milestone payments related revenues
accounting for the remaining $4.2 million.
Xtandi is approved for the treatment of patients with
metastatic castration-resistant prostate cancer who have
previously received docetaxel. Xtandi is currently approved in 12
countries and under regulatory review in 35 countries.
Operating expenses increased 5.6% to $68 million. Research and
development expenses decreased 10.3% to $28.7 million. SG&A
expenses increased 21.5% to $39.3 million.
Medivation still expects operating expenses (after adjusting
cost-sharing payments) in the range of $285-$300 million. The
company, however, expects Xtandi U.S. net sales (reported by
Astellas) to surpass the earlier guidance of $345-$365
Medivation is working on expanding Xtandi's label. Interim
results from the phase III PREVAIL study on pre-chemo patients
showed that patients on Xtandi experienced a statistically
significant overall survival advantage compared with patients
receiving placebo. A 30% reduction in risk of death was observed
in the Xtandi arm compared to placebo. Risk of radiographic
progression or death went down by 81% in the Xtandi arm compared
Considering the overall survival benefit and safety profile,
the Independent Data Monitoring Committee recommended that
patients on placebo should be offered treatment with Xtandi.
Medivation and Astellas intend to meet with regulatory agencies
early next year.
Meanwhile, Medivation has commenced a phase IV study (PLATO)
on Xtandi which will compare Xtandi plus Zytiga and prednisone to
Zytiga and prednisone in chemo-naïve metastatic prostate cancer
patients whose disease has progressed following treatment with
Xtandi. Xtandi is being evaluated in other studies as well,
including a breast cancer study.
We remain encouraged by Xtandi's performance. Xtandi could
very well be a game-changer for Medivation. The prostate cancer
market represents huge commercial potential and Xtandi continues
to perform well. Launch in additional countries should drive
sales further. Medivation has consistently presented impressive
data on Xtandi. Expansion into the pre-chemo setting would be a
major positive for Medivation.
Medivation is currently a Zacks Rank #3 (Hold) stock. At
present, companies like
Vanda Pharmaceuticals, Inc.
Osiris Therapeutics, Inc.
) look attractive with both being Zacks Rank #1 (Strong Buy)
MEDIVATION INC (MDVN): Free Stock Analysis
OSIRIS THERAPTC (OSIR): Free Stock Analysis
VANDA PHARMACT (VNDA): Free Stock Analysis
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