Medivation Inc. ( MDVN ) reported a
first-quarter loss of 36 cents per share, narrower than the Zacks
Consensus Estimate of a loss of 41 cents per share. However, the
company recorded earnings of 1 cent in the year-ago quarter.
Revenues came in at $46.2 million, above the Zacks Consensus
Estimate of $38 million and the year-ago revenues of $36.8
The Quarter in Detail
Xtandi delivered net sales of $75.4 million in the first
quarter, $18 million above the last quarter of 2012. Revenues were
driven by higher volumes and a favorable gross to net adjustment of
about $4.4 million taken by Astellas ( ALPMY ).
Xtandi is approved for the treatment of patients with metastatic
castration-resistant prostate cancer who have previously received
docetaxel. Xtandi is currently under regulatory review in the EU
(positive opinion gained in Apr 2013) with a decision expected in
the June-July timeframe. EU approval would trigger a $15 million
milestone payment from Astellas.
Operating expenses increased 91.9% to $68.5 million. Research
and development expenses increased 24.4% to $24.9 million. SG&A
expenses increased 177.7% to $43.6 million.
2013 Outlook Maintained
Medivation still expects operating expenses (after adjusting
cost-sharing payments) in the range of $285-$300 million.
Medivation is working on expanding Xtandi's label. Interim
results from the phase III PREVAIL study on pre-chemo patients
should be out later this year. The company also intends to start a
phase III trial in patients with non-metastatic
castration-resistant prostate cancer this year.
Xtandi is being evaluated in other studies as well, including a
breast cancer study.
We are encouraged by Xtandi's performance. Xtandi, which was
launched in the US in Sep 2012, could very well be a game-changer
for Medivation. The prostate cancer market represents huge
commercial potential and Xtandi is already off to a strong start.
Medivation has consistently presented impressive data on Xtandi.
Based on the data we have seen so far, we believe the product has
blockbuster potential. Xtandi is currently in several studies
including studies for the pre-chemo setting. Expansion into the
pre-chemo setting would be a major positive for the stock.
Medivation is currently a Zacks Rank #3 (Hold) stock. At
present, companies like Athersys, Inc. ( ATHX ) and
Cytori Therapeutics, Inc. ( CYTX ) look
well-positioned. Both are Zacks Rank #1 (Strong Buy) stocks.ASTELLAS PHARMA (ALPMY): Get Free ReportATHERSYS INC (ATHX): Free Stock Analysis ReportCYTORI THERAPEU (CYTX): Free Stock Analysis
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