) reported a third quarter loss of 6 cents per share, narrower
than the Zacks Consensus Estimate of a loss of 9 cents per share
and the year-ago loss of 14 cents per share.
Revenues came in at $64.8 million, well above the Zacks
Consensus Estimate of $49 million and the year-ago revenues of
The Quarter in Detail
Third quarter 2012 revenues included US Xtandi sales of $7.1
million and collaboration revenue of $57.7 million from partner
Astellas and former partner
Revenues included milestone payments of $45 million from
Astellas based on the FDA's acceptance and approval of the Xtandi
New Drug Application (NDA) and the acceptance of the Xtandi
marketing authorization application (MAA) in the EU for
Xtandi, which was launched on September 13, delivered net
sales of $14.1 million. Xtandi is approved for the treatment of
patients with metastatic castration-resistant prostate cancer who
have previously received docetaxel.
Operating expenses increased 143.9% to $64.4 million. Research
and development expenses increased 318.8% to $32.0 million.
SG&A expenses increased 71.3% to $32.3 million.
Medivation now expects operating expenses (after adjusting
cost-sharing payments from Astellas) in the range of $205 - $215
million, up from the previous guidance of $183 - $198 million.
Higher royalty expense and non-cash stock-based compensation
costs led to the upward revision in operating expense
Medivation expects capex of about $15 million, especially
connected with its new headquarters.
Meanwhile, Medivation is evaluating Xtandi in the pre-chemo
setting which represents huge commercial opportunity. Besides
conducting the phase III PREVAIL study (chemotherapy-naïve
advanced prostate cancer patients), Xtandi is in a phase II study
(TERRAIN), which will compare Xtandi with bicalutamide, in
advanced prostate cancer patients who have progressed following
medical castration with LHRH analog therapy or surgical
Another study (STRIVE) is being conducted mainly in the US in
patients with either metastatic or non-metastatic disease. A
third study (ASPIRE) is being conducted in chemo-naïve patients.
Medivation is also evaluating Xtandi at the earliest stage of
prostate cancer, when the disease is initially diagnosed.
Medivation is enrolling patients in an open-label clinical trial
which will study Xtandi as a new adjuvant therapy prior to
prostatectomy. Medivation is also exploring Xtandi for breast
cancer (phase I).
Xtandi, which was launched in the US in September, is off to a
strong start. The product could very well be a game-changer for
Medivation. The prostate cancer market represents huge commercial
potential. Medivation has consistently presented impressive data
on Xtandi. Based on the data we have seen so far, we believe the
product has blockbuster potential. We expect investor focus to
remain on the commercialization of Xtandi.
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