Medivation Reports Third Quarter 2009 Financial Results and Provides Corporate
Update
-- Company Received $110 Million Up-Front Payment from Astellas --
SAN FRANCISCO, Nov. 4 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq:
MDVN) today reported on its corporate progress and financial results for the
third quarter ended September 30, 2009.
"With the signing of our agreement for MDV3100 with Astellas last week, we now
have a first-class partner with a global reach, leading commercial presence in
the urology space, and strategic focus on oncology. This achievement marks
our second major collaboration in just over a year's time, bringing us
significant resources which allow us to drive our product candidates forward,
while still maintaining substantial ownership of our dimebon and MDV3100
programs. We and Astellas are committed to advancing development of this novel
androgen receptor antagonist as quickly as possible for a broad spectrum of
prostate cancer disease states," said David Hung, M.D., president and chief
executive officer of Medivation. "We also made important progress with
dimebon and now have seven pivotal trials in our broad clinical development
program in both Alzheimer's and Huntington diseases in various stages of
activity. We have reported results from our first pivotal trial, we expect
data in the first half of next year from our second confirmatory pivotal
trial, and five other pivotal trials are ongoing."
Recent Accomplishments and Near-Term Milestones
Dimebon (latrepirdine*)
-- On track to announce top-line results from CONNECTION, a confirmatory,
pivotal Phase 3 trial in patients with mild-to-moderate Alzheimer's
disease, in the first half of 2010.
-- Completed patient enrollment in a placebo-controlled Phase 3 safety
study in 750 Alzheimer's disease patients on a variety of background
anti-dementia drugs.
-- Initiated patient enrollment in CONSTELLATION, a six-month,
randomized,
double-blind, placebo-controlled Phase 3 trial in approximately 570
patients with moderate-to-severe Alzheimer's disease that will
evaluate
as primary endpoints the effects of adding dimebon to Namenda®, a
standard of care Alzheimer's disease medicine, on cognitive and
behavioral symptoms.
-- Initiated patient enrollment in CONTACT, a six-month, randomized,
double-blind, placebo-controlled Phase 3 trial in approximately 600
patients with moderate-to-severe Alzheimer's disease that will assess
as
primary endpoints the potential benefits of adding dimebon to ongoing
treatment with Aricept®, the leading Alzheimer's medication worldwide,
on neuropsychiatric symptoms and activities of daily living. This
study
is the first pivotal Alzheimer's disease study to use the
Neuropsychiatric Inventory (NPI) scale as a co-primary endpoint.
-- Continued patient enrollment in CONCERT, a 12-month Phase 3 clinical
trial in patients with mild-to-moderate Alzheimer's disease that is
designed to evaluate the efficacy of dimebon when added to ongoing
treatment with Aricept.
-- Continued patient enrollment in HORIZON, a six-month, double-blind,
placebo-controlled Phase 3 trial that is evaluating dimebon's
potential
benefits on cognition in patients with Huntington disease.
*Latrepirdine is the proposed generic name for dimebon.
MDV3100
-- Entered into a global collaboration agreement with Astellas Pharma
Inc.
to develop and commercialize MDV3100 for the treatment of prostate
cancer. Under the terms of the agreement, Medivation has received an
up-front cash payment of $110 million and is also eligible to receive
payments of up to $335 million upon the attainment of development and
regulatory milestones, plus up to an additional $320 million in
commercial milestone payments.
-- Initiated AFFIRM, a randomized, placebo-controlled, double-blind Phase
3
survival trial that is evaluating 160 mg/day of MDV3100 in men with
castration-resistant prostate cancer who were previously treated with
docetaxel-based chemotherapy.
Corporate
-- Appointed Hank Mansbach, M.D., a neurologist with more than 10 years
of
industry experience, as vice president, medical affairs.
Third Quarter 2009 Financial Results
Revenue for the third quarter of 2009 was $16.3 million, consisting of partial
recognition of the non-refundable up-front payment of $225.0 million received
from Pfizer in October 2008. The up-front payment was recorded as deferred
revenue upon receipt and is being recognized on a straight-line basis over the
estimated performance period of the Company's obligations under its
collaboration agreement with Pfizer, which the Company presently expects to
complete in the first quarter of 2012.
Total operating expenses for the three months ended September 30, 2009, were
$27.6 million, compared with total operating expenses of $20.6 million for the
same period in 2008. These figures included non-cash stock-based compensation
expense of $2.5 million in the quarter ended September 30, 2009, compared with
$2.3 million for the same period in 2008.
For the nine months ended September 30, 2009, total operating expenses were
$73.8 million, compared with total operating expenses of $55.3 million for the
same period in 2008. These figures included non-cash stock-based compensation
expense of $7.7 million in the nine months ended September 30, 2009, compared
with $6.4 million for the same period in 2008.
Beginning October 21, 2008, Pfizer became responsible for 60 percent of all
dimebon-related development and commercialization costs in the U.S., and 100
percent of such costs outside the U.S. The parties are making quarterly
true-up payments as necessary to ensure that each bears its applicable share
of costs. For the third quarter of 2009, the true-up payment payable to
Medivation was $4.2 million. Medivation presents these cost-sharing true-up
payments in the applicable expense line of its statements of operations.
Medivation reported a net loss for the quarter ended September 30, 2009, of
$14.0 million, or $0.42 per share, compared with a net loss of $20.5 million,
or $0.68 per share, for the same period in 2008. For the nine months ended
September 30, 2009, the net loss was $28.5 million, or $0.90 per share,
compared with a net loss of $54.5 million, or $1.86 per share, for the same
period in 2008.
Cash, cash equivalents and short-term investments at September 30, 2009,
totaled $214.5 million, compared with $221.4 million at December 31, 2008, and
$237.7 million at June 30, 2009. This does not include the $110 million
up-front payment Medivation received from Astellas on November 2, 2009
pursuant to the MDV3100 collaboration agreement.
Updated 2009 Financial Outlook
Medivation currently expects that total operating expenses for 2009, net of
cost-sharing payments with Pfizer and Astellas, will be between $115 and $120
million, down from its prior forecast of between $117 and $127 million. Both
the current and prior forecasts include approximately $10 million of non-cash
stock-based compensation expense.
Conference Call Information
To participate by telephone in today's live call beginning at 4:30 p.m.
Eastern Time by telephone, please call 877-874-1563 from the U.S. or
+1-719-325-4891 internationally. In addition, the live conference call is
being webcast and can be accessed on the "Events and Presentations" page of
the "Investor Relations" section of the Company's website at
www.medivation.com. A replay also will be available for 30 days following the
live call.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid
development of novel small molecule drugs to treat serious diseases for which
there are limited treatment options. Medivation aims to transform the
treatment of these diseases and offer hope to critically ill patients and
their caregivers. In September 2008, Medivation announced a global agreement
with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the
treatment of Alzheimer's and Huntington diseases. With Pfizer, Medivation is
conducting a broad dimebon clinical development program that includes several
Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in
combination with other Alzheimer's medications in patients with mild, moderate
and severe Alzheimer's disease. The companies are also conducting a Phase 3
trial of dimebon in Huntington disease. In October 2009, Medivation entered a
global agreement with Astellas Pharma Inc. to develop and commercialize
MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100
development program, known as the AFFIRM trial, is under way in patients with
castration-resistant prostate cancer who have previously been treated with
docetaxel-based chemotherapy. For more information, please visit us at
http://www.medivation.com.
This press release contains forward-looking statements, including statements
regarding the continued clinical development of Medivation's product
candidates, the timing of clinical trial initiation and clinical trial data,
the therapeutic and commercial potential of Medivation's product candidates,
the performance of Medivation's obligations under its collaboration agreement
with Pfizer and continuing true-up payments thereunder, potential future
milestone payments under Medivation's collaboration agreement with Astellas,
and future expected financial results, which are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause
Medivation's actual results to differ significantly from those projected,
including, without limitation, risks related to progress, timing and results
of Medivation's clinical trials, difficulties or delays in obtaining
regulatory approval, enrollment of patients in Medivation's clinical trials,
partnering of Medivation's product candidates, including Medivation's
dependence on the efforts of and funding by Pfizer and Astellas for the
development of dimebon and MDV3100, respectively, the achievement of
development, regulatory and commercial milestones under Medivation's
collaboration agreements, manufacturing of Medivation's product candidates,
competition with Medivation's product candidates should they receive marketing
approval, the adequacy of Medivation's financial resources, unanticipated
expenditures or liabilities, intellectual property matters, and other risks
detailed in Medivation's filings with the Securities and Exchange Commission,
including its quarterly report on Form 10-Q for the quarter ended September
30, 2009, filed today with the SEC. You are cautioned not to place undue
reliance on the forward-looking statements, which speak only as of the date of
this release. Medivation disclaims any obligation or undertaking to update or
revise any forward-looking statements contained in this press release.
~financial statements follow~
MEDIVATION, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Nine Months
Ended Ended
September 30, September 30,
-------------- --------------
2009 2008 2009 2008
---- ---- ---- ----
Collaboration revenue $16,341 $- $49,021 $-
------- -- ------- --
Operating expenses:
Research and development 21,530 15,514 54,851 41,728
Selling, general
and administrative 6,034 5,122 18,950 13,532
------ ------ ------ ------
Total operating expenses 27,564 20,636 73,801 55,260
------ ------ ------ ------
Loss from operations (11,223) (20,636) (24,780) (55,260)
Other income (expense):
Interest income 153 170 967 735
Other income (expense), net (57) 10 (154) (2)
--- -- ---- --
Total other income 96 180 813 733
-- --- --- ---
Loss before provision for
income taxes (11,127) (20,456) (23,967) (54,527)
Provision for income taxes 2,846 - 4,538 2
----- --- ----- ---
Net loss $(13,973) $(20,456) $(28,505) $(54,529)
======== ======== ======== ========
Basic and diluted net
loss per share $(0.42) $(0.68) $(0.90) $(1.86)
====== ====== ====== ======
Weighted average common
shares used
in the calculation of basic
and diluted
net loss per share 33,468 30,022 31,588 29,273
====== ====== ====== ======
MEDIVATION, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
(unaudited)
September December
30, 31,
2009 2008
---- ----
ASSETS
Current assets:
Cash and cash equivalents $56,502 $71,454
Short-term investments 157,955 149,968
Receivable from collaboration partner 4,218 3,522
Prepaid expenses and
other current assets 6,011 1,957
----- -----
Total current assets 224,686 226,901
Property and equipment, net 1,070 768
Restricted cash 843 843
Intellectual property, net 51 54
Other non-current assets 694 706
--- ---
Total assets $227,344 $229,272
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $5,447 $7,166
Accrued expenses 12,998 5,772
Deferred revenue 65,361 64,286
Other current liabilities 121 93
--- --
Total current liabilities 83,927 77,317
Deferred revenue, net of current 98,041 148,137
Other non-current liabilities 360 399
Series A redeemable preferred stock 11 11
-- --
Total liabilities 182,339 225,864
------- -------
Stockholders' equity:
Preferred stock, $0.01 par value per share;
1,000,000 shares authorized; no
shares issued and outstanding - -
Common stock, $0.01 par value per share;
50,000,000 shares authorized; issued
and outstanding 33,504,743 shares
at September 30, 2009 and 30,088,390
at December 31, 2008 335 301
Additional paid-in capital 195,736 125,074
Accumulated other comprehensive income 99 693
Accumulated deficit (151,165) (122,660)
-------- --------
Total stockholders' equity 45,005 3,408
------ -----
Total liabilities and stockholders' equity $227,344 $229,272
======== ========
SOURCE Medivation, Inc.
Patrick Machado, Chief Financial Officer of Medivation, Inc., +1-415-829-4101;
or Nicole Foderaro of WeissComm Partners, +1-415-946-1058, for Medivation,
Inc
http://www.reuters.com/article/pressRelease/idUS222044+04-Nov-2009+PRN20091104
Related Websites - 2 New Loans (Part 1/2) -- CCSJ Marketing Acquisition & Expansion -- $20,000 at 15.65% -- C Credit -- DTI 14% A new loan funded this afternoon (CCSJ Marketing Acquisition & Expansion  (Loan #6383) â $20,000 at 15.65%). I participated via my standing order: Low DTI -- AF. Which is this loan was funded as...
- Stay far, far, far away from Swoopo And if you bid on Swoopo.com, please stop. Even if you've won an auction. I can just about guarantee you'll pay back every cent you saved on that one auction win, plus a lot more....
- 1,100 Species To Go Extinct In 2008. This is what we want to leave for future generations? Thousands of species going extinct each year? I hope not. The IUCN Red List for 2008 includes the monitoring of 44,838 species, of which 869...
Tags: Astellas, Broad Spectrum, Cancer Disease, Chief Executive Officer, Commercial Presence, Disease Patients, Disease States, Mdvn, Medivation Inc, Patient Enrollment, Pivotal Trial, Pivotal Trials, Prnewswire, Product Candidates, Prostate Cancer, Quarter Ended September, Receptor Antagonist, Safety Study, Significant Resources, Third Quarter Ended September