x
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
Delaware
(State
or other jurisdiction of incorporation or organization)
|
11-1798614
(I.R.S.
Employer
Identification
Number)
|
|
909
Third Avenue
New
York, New York
(Address
of principal executive offices)
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10022-4731
(Zip
code)
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Large
accelerated filer x
|
Accelerated
filer o
|
Non-accelerated
filer o
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Smaller
reporting company o
|
(Do
not check if a smaller reporting company)
|
(In
thousands)
|
December
31, 2008
(Unaudited)
|
March 31, 2008
|
||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
(including cash equivalent investments of $1,326,337 in December and
$833,018 in March)
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$ | 1,326,951 | $ | 833,052 | ||||
Marketable
securities
|
862,886 | 943,972 | ||||||
Accounts
receivable, less allowance for doubtful accounts of $18,423 in December
and $19,882 in March
|
428,892 | 445,987 | ||||||
Inventories,
net
|
396,352 | 425,138 | ||||||
Deferred
income taxes
|
219,872 | 226,095 | ||||||
Other
current assets
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57,826 | 33,260 | ||||||
Total
current assets
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3,292,779 | 2,907,504 | ||||||
Marketable
securities
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673,180 | 663,625 | ||||||
Property,
plant and equipment
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595,097 | 567,331 | ||||||
Less:
accumulated depreciation
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245,606 | 217,294 | ||||||
349,491 | 350,037 | |||||||
Other
assets:
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||||||||
Goodwill
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14,965 | 14,965 | ||||||
License
agreements, product rights and other intangibles, less accumulated
amortization of $465,994 in December and $421,719 in March
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481,903 | 527,787 | ||||||
Deferred
income taxes
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90,911 | 59,778 | ||||||
Other
assets
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1,596 | 1,671 | ||||||
Total
other assets
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589,375 | 604,201 | ||||||
Total
assets
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$ | 4,904,825 | $ | 4,525,367 | ||||
See
notes to condensed consolidated financial statements.
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(In
thousands, except for par values)
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December
31, 2008
(Unaudited)
|
March 31, 2008
|
||||||
Liabilities and Stockholders'
Equity
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
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$ | 61,407 | $ | 223,720 | ||||
Accrued
expenses
|
542,536 | 387,105 | ||||||
Total
current liabilities
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603,943 | 610,825 | ||||||
Long-term
liabilities:
|
||||||||
Income
tax liabilities
|
257,980 | 198,410 | ||||||
Deferred
income taxes
|
833 | 815 | ||||||
258,813 | 199,225 | |||||||
Stockholders'
equity:
|
||||||||
Series
preferred stock, $1.00 par; shares authorized 1,000; no shares issued or
outstanding
|
||||||||
Common
stock, $.10 par; shares authorized 1,000,000; issued 422,266 shares in
December and 421,421 shares in March
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42,226 | 42,142 | ||||||
Additional
paid-in capital
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1,478,679 | 1,434,172 | ||||||
Retained
earnings
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6,286,474 | 5,611,493 | ||||||
Accumulated
other comprehensive (loss) income
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( 14,368 | ) | 34,592 | |||||
Treasury
stock, at cost (120,653 shares in December and 110,014 shares in
March)
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( 3,750,942 | ) | ( 3,407,082 | ) | ||||
Total
stockholders' equity
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4,042,069 | 3,715,317 | ||||||
Total
liabilities and stockholders' equity
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$ | 4,904,825 | $ | 4,525,367 | ||||
See
notes to condensed consolidated financial statements.
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Three
Months Ended
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Nine
Months Ended
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|||||||||||||||
(In
thousands, except per share amounts)
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December 31,
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December 31,
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||||||||||||||
2008
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2007
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2008
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2007
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|||||||||||||
Net
sales
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$ | 920,013 | $ | 918,146 | $ | 2,739,329 | $ | 2,603,099 | ||||||||
Contract
revenue
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52,433 | 52,705 | 153,796 | 156,395 | ||||||||||||
Interest
income
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24,235 | 25,862 | 61,658 | 77,532 | ||||||||||||
Other
income
|
1,274 | 1,529 | 2,522 | 8,450 | ||||||||||||
997,955 | 998,242 | 2,957,305 | 2,845,476 | |||||||||||||
Costs
and expenses:
|
||||||||||||||||
Cost
of sales
|
206,654 | 213,506 | 608,995 | 589,738 | ||||||||||||
Selling,
general and administrative
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289,968 | 285,652 | 959,184 | 827,419 | ||||||||||||
Research
and development
|
279,051 | 108,246 | 537,520 | 415,892 | ||||||||||||
775,673 | 607,404 | 2,105,699 | 1,833,049 | |||||||||||||
Income
before income tax expense
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222,282 | 390,838 | 851,606 | 1,012,427 | ||||||||||||
Income
tax expense
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34,307 | 89,081 | 176,625 | 217,264 | ||||||||||||
Net
income
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$ | 187,975 | $ | 301,757 | $ | 674,981 | $ | 795,163 | ||||||||
Net
income per common share:
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||||||||||||||||
Basic
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$ | 0.62 | $ | 0.97 | $ | 2.22 | $ | 2.52 | ||||||||
Diluted
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$ | 0.62 | $ | 0.96 | $ | 2.21 | $ | 2.51 | ||||||||
Weighted
average number of common shares outstanding:
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||||||||||||||||
Basic
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301,428 | 312,140 | 304,262 | 315,729 | ||||||||||||
Diluted
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302,056 | 313,107 | 305,147 | 317,279 | ||||||||||||
See
notes to condensed consolidated financial statements.
|
Three
Months Ended
|
Nine
Months Ended
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|||||||||||||||
(In
thousands)
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December 31,
|
December 31,
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||||||||||||||
2008
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2007
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2008
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2007
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|||||||||||||
Net
income
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$ | 187,975 | $ | 301,757 | $ | 674,981 | $ | 795,163 | ||||||||
Other
comprehensive (loss) income:
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||||||||||||||||
Foreign
currency translation (losses) gains
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( 7,299 | ) | 4,622 | ( 25,112 | ) | 12,812 | ||||||||||
Unrealized
losses on securities:
|
||||||||||||||||
Unrealized
holding loss arising
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||||||||||||||||
during
the period, net of tax
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( 12,775 | ) | ( 5,699 | ) | ( 23,848 | ) | ( 5,412 | ) | ||||||||
Other
comprehensive (loss) income
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( 20,074 | ) | ( 1,077 | ) | ( 48,960 | ) | 7,400 | |||||||||
Comprehensive
income
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$ | 167,901 | $ | 300,680 | $ | 626,021 | $ | 802,563 | ||||||||
See
notes to condensed consolidated financial statements.
|
Nine
Months Ended
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||||||||
(In
thousands)
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December 31,
|
|||||||
2008
|
2007
|
|||||||
Cash
flows from operating activities:
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||||||||
Net
income
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$ | 674,981 | $ | 795,163 | ||||
Adjustments
to reconcile net income to net cash provided by operating
activities:
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||||||||
Depreciation
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32,383 | 34,988 | ||||||
Amortization
and impairments
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44,275 | 31,789 | ||||||
Stock-based
compensation expense
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31,516 | 30,719 | ||||||
Deferred
income tax benefit
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( 24,892 | ) | ( 24,209 | ) | ||||
Foreign
currency transaction gain
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( 1,392 | ) | ( 1,420 | ) | ||||
Net
change in operating assets and liabilities:
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||||||||
Decrease
(increase) in:
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||||||||
Accounts
receivable, net
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17,095 | ( 21,732 | ) | |||||
Inventories,
net
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28,786 | ( 3,979 | ) | |||||
Other
current assets
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( 24,566 | ) | ( 8,476 | ) | ||||
Other
assets
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75 | 7,889 | ||||||
Increase
(decrease) in
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||||||||
Accounts
payable
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( 162,313 | ) | 11,146 | |||||
Accrued
expenses
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155,431 | 23,471 | ||||||
Income
taxes liabilities
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59,570 | 80,574 | ||||||
Net
cash provided by operating activities
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830,949 | 955,923 | ||||||
Cash
flows from investing activities:
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||||||||
Purchase
of property, plant and equipment
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( 33,026 | ) | ( 23,906 | ) | ||||
Purchase
of marketable securities
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( 1,646,523 | ) | ( 2,062,330 | ) | ||||
Redemption
of marketable securities
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1,718,054 | 1,720,777 | ||||||
Purchase
of license agreements, product rights and other
intangibles
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( 45,000 | ) | ||||||
Net
cash provided by (used in) investing activities
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38,505 | ( 410,459 | ) | |||||
Cash
flows from financing activities:
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||||||||
Net
proceeds from common stock options exercised by employees under stock
option plans
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10,629 | 25,672 | ||||||
Tax
benefit realized from the exercise of stock options by
employees
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2,446 | 3,442 | ||||||
Purchase
of treasury stock
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( 343,860 | ) | ( 356,327 | ) | ||||
Net
cash used in financing activities
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( 330,785 | ) | ( 327,213 | ) | ||||
Effect
of exchange rate changes on cash
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( 44,770 | ) | 7,795 | |||||
Increase
in cash and cash equivalents
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493,899 | 226,046 | ||||||
Cash
and cash equivalents, beginning of period
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833,052 | 563,663 | ||||||
Cash
and cash equivalents, end of period
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$ | 1,326,951 | $ | 789,709 |
Supplemental
disclosures of cash flow information:
|
||||||||
Cash
paid during the period for:
|
||||||||
Income
taxes
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$ | 141,691 | $ | 157,512 | ||||
See
notes to condensed consolidated financial statements.
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December
31, 2008
(Unaudited)
|
March 31, 2008
|
|||||||
Trade
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$ | 326,472 | $ | 377,779 | ||||
Other
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102,420 | 68,208 | ||||||
$ | 428,892 | $ | 445,987 |
December
31, 2008
(Unaudited)
|
March 31, 2008
|
|||||||
Raw
materials
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$ | 146,891 | $ | 234,288 | ||||
Work
in process
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936 | 1,360 | ||||||
Finished
goods
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248,525 | 189,490 | ||||||
$ | 396,352 | $ | 425,138 |
Level
1:
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Observable
inputs such as quoted prices for identical assets or liabilities in active
markets.
|
|
Level
2:
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Observable
inputs other than quoted prices that are directly or indirectly observable
for the asset or liability, including quoted prices for similar assets or
liabilities in active markets; quoted prices for similar or identical
assets or liabilities in markets that are not active; and model-derived
valuations whose inputs are observable or whose significant value drivers
are observable.
|
|
Level
3:
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Unobservable
inputs that reflect the reporting entity’s own
assumptions.
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Description
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Fair
Value at
December 31,
2008
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Quoted
Prices in Active Markets for Identical Assets
(Level 1)
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Significant
Other Observable Market Inputs
(Level
2)
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Unobservable
Market Inputs
(Level 3)
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||||||||||||
Money
market accounts
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$ | 1,090,410 | $ | 1,090,410 | ||||||||||||
Municipal
bonds and notes
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196,125 | $ | 196,125 | |||||||||||||
Commercial
paper
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782,950 | 394,663 | 388,287 | |||||||||||||
Variable
rate demand notes
|
162,864 | 162,864 | ||||||||||||||
Floating
rate notes
|
411,959 | 248,473 | 163,486 | |||||||||||||
Auction
rate securities
|
36,889 | $ | 36,889 |
Three
Months Ended December 31, 2008
|
||||
Transfers
to Level 3
|
$ | 38,795 | ||
Gains
and losses reported in accumulated other comprehensive
income
|
( 1,906 | ) | ||
Balance
at December 31, 2008
|
$ | 36,889 |
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
December 31,
|
December 31,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Basic
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301,428 | 312,140 | 304,262 | 315,729 | ||||||||||||
Effect
of assumed conversion of employee stock options and restricted
stock
|
628 | 967 | 885 | 1,550 | ||||||||||||
Diluted
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302,056 | 313,107 | 305,147 | 317,279 |
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
December 31,
|
December 31,
|
|||||||||||||||
2008
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2007
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2008
|
2007
|
|||||||||||||
Central
nervous system
|
$ | 829,384 | $ | 825,843 | $ | 2,472,816 | $ | 2,330,320 | ||||||||
Cardiovascular
|
25,501 | 6,478 | 54,909 | 21,746 | ||||||||||||
Other
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65,128 | 85,825 | 211,604 | 251,033 | ||||||||||||
$ | 920,013 | $ | 918,146 | $ | 2,739,329 | $ | 2,603,099 |
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·
|
In
December 2007, we submitted a New Drug Application (or NDA) to the FDA for
milnacipran in the treatment of fibromyalgia syndrome based on data from
two Phase III studies which demonstrated significant therapeutic
effects. On January 14, 2009 we received FDA approval for
Savella (milnacipran HCl) for the management of
fibromyalgia. In December 2008, we received positive top-line
results from an additional randomized Phase III study completed post NDA
submission.
|
|
·
|
In
May 2008, we filed a supplemental New Drug Application (or sNDA) for
Lexapro for the additional indication of adolescent
depression. The filing included the results from a Phase III
study of Lexapro in the treatment of adolescents aged 12-17, with Major
Depressive Disorder, which indicate that patients treated with Lexapro
experienced statistically significant improvement in symptoms of
depression. The FDA has set an action date for March 2009 for
this sNDA.
|
|
·
|
In
connection with our acquisition of Cerexa, Inc. in January 2007, we
acquired worldwide development and marketing rights (excluding Japan) to
ceftaroline, a next generation, broad-spectrum, hospital-based injectable
cephalosporin antibiotic with activity against gram-positive bacteria such
as MRSA and gram-negative bacteria. In June 2008, we reported
positive results from two globally conducted, multi-center Phase III
studies of ceftaroline for complicated skin and skin structure
infections. We are also conducting two Phase III studies for
community acquired pneumonia and we anticipate those results by the second
quarter of calendar 2009. The data from these two indications,
if supportive, will serve as our planned submission package to the FDA for
initial marketing approval.
|
|
·
|
In
April 2006, we entered into a collaboration agreement with Laboratorios
Almirall, S.A. (or Almirall) for the U.S. rights to aclidinium, a novel
long-acting muscarinic antagonist which is being developed as an inhaled
therapy for the treatment of chronic obstructive pulmonary disease (or
COPD). In September 2008 we received positive results from two
Phase III studies assessing the safety and efficacy of aclidinium in
moderate to severe COPD. We expect to meet with the FDA in
early calendar 2009 to review these results. Pending FDA
feedback, we plan to file an NDA in late calendar 2009 or early calendar
2010. We and Almirall are also pursuing the development of a
fixed-dose combination of aclidinium and the beta-agonist formoterol,
which is currently in Phase II
testing.
|
|
·
|
During
the September 2007 quarter, we entered into a partnership with Ironwood to
co-develop and co-market the compound linaclotide for North
America. Linaclotide is currently being investigated for the
treatment of constipation-predominant irritable bowel syndrome (or IBS-C)
and chronic constipation (or CC). Based on positive results of
a Phase II(b) randomized, double-blind, placebo-controlled studies
assessing the safety and efficacy of linaclotide in patients with CC and
IBS-C, we have initiated a comprehensive Phase III clinical
program. The CC studies have been initiated and we expect to
report top-line data in the fourth quarter of calendar
2009. The IBS-C trials are anticipated to begin during the
first quarter of calendar 2009.
|
|
·
|
During
the third quarter of fiscal 2005, Forest entered into a collaboration
agreement with Gedeon Richter Ltd. (or Richter) for the North American
rights to cariprazine and related compounds, being developed as an
atypical antipsychotic for the treatment of schizophrenia, bipolar mania
and other psychiatric conditions. In September 2008, we
received positive preliminary top-line results from an additional Phase II
study of cariprazine in patients with acute mania associated with bipolar
disorder. A review of top-line results of a Phase II study in
schizophrenia indicated that cariprazine demonstrated a nominally
statistical significant (i.e., not adjusted for multiple comparisons)
therapeutic effect compared to placebo in a low-dose arm and a numerical
improvement compared to placebo in a high-dose arm that did not reach
nominal statistical significance. Based on the review of the
results, we and Richter initiated a Phase II(b) dose-ranging study in
schizophrenia patients. This study is being performed in order
to better determine an optimal dose to take into the planned Phase III
program. We expect to report this data in the second half of
calendar 2009.
|
|
·
|
Regarding
Bystolic (nebivolol hydrochloride), we plan to file an sNDA in the first
half of calendar 2009 for a new indication of congestive heart failure
based on the results of the Phase III Seniors
study.
|
|
·
|
In
February 2008, we received preliminary results of a Phase III study of
memantine HCl in a novel once-daily formulation of Namenda for the
treatment of moderate to severe Alzheimer’s disease. The results
indicated that patients treated with this formulation experienced
statistically significant benefits in cognition and clinical global status
compared to placebo. Based on the results of this study, we intend
to prepare an NDA for this new once-daily formulation in the first half of
calendar 2009.
|
|
·
|
During
the second quarter of fiscal 2005, Forest entered into a collaboration
agreement with Glenmark Pharmaceuticals Ltd. for the North American
development and marketing of GRC 3886, a PDE4 inhibitor for the treatment
of asthma and COPD. We have commenced a Phase II study of this
compound for the COPD indication with results expected in the second half
of calendar 2009.
|
December 31, 2008
|
December 31, 2007
|
|||||||
Beginning
balance
|
$ | 229,681 | $ | 208,063 | ||||
Provision
for rebates
|
375,892 | 317,947 | ||||||
Changes
in estimates
|
2,500 | |||||||
Settlements
|
( 356,734 | ) | ( 306,782 | ) | ||||
19,158 | 13,665 | |||||||
Provision
for returns
|
22,432 | 24,134 | ||||||
Changes
in estimates
|
||||||||
Settlements
|
( 17,967 | ) | ( 22,704 | ) | ||||
4,465 | 1,430 | |||||||
Provision
for chargebacks and discounts
|
225,189 | 262,915 | ||||||
Changes
in estimates
|
( 7,700 | ) | ||||||
Settlements
|
( 226,225 | ) | ( 266,145 | ) | ||||
( 1,036 | ) | ( 10,930 | ) | |||||
Ending
balance
|
$ | 252,268 | $ | 212,228 |
Item
6.
|
Exhibits
|
|
Amended
and Restated Change of Control Employment Agreement between Forest and
Howard Solomon dated October 29, 2008.
|
||
Amended
and Restated Change of Control Employment Agreement between Forest and
Lawrence S. Olanoff, M.D., Ph.D dated October 29, 2008.
|
||
Amended
and Restated Change of Control Employment Agreement between Forest and
Elaine Hochberg dated October 29, 2008.
|
||
Amended
and Restated Change of Control Employment Agreement between Forest and
Francis I. Perier, Jr. dated October 29, 2008.
|
||
Amended
and Restated Change of Control Employment Agreement between Forest and
Marco Taglietti dated October 29, 2008.
|
||
Amended
and Restated Change of Control Employment Agreement between Forest and
Herschel Weinstein dated October 29, 2008.
|
||
Amended
and Restated Change of Control Employment Agreement between Forest and
Frank Murdolo dated October 29, 2008.
|
||
Amended
and Restated Change of Control Employment Agreement between Forest and
David Solomon dated October 29, 2008.
|
||
Amended
and Restated Change of Control Employment Agreement between Forest and
Raymond Stafford dated October 29, 2008.
|
||
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
||
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
||
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
||
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|