x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
o
|
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)
|
10022-4731
(Zip
code)
|
Large
accelerated filer x
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company o
|
(Do
not check if a smaller reporting company)
|
(In
thousands)
|
September
30, 2008
(Unaudited)
|
March 31, 2008
|
||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
(including cash equivalent investments of $1,069,005 in September and
$833,018 in March)
|
$ | 1,069,842 | $ | 833,052 | ||||
Marketable
securities
|
820,025 | 943,972 | ||||||
Accounts
receivable, less allowance for doubtful accounts of $18,880 in September
and $19,882 in March
|
423,023 | 445,987 | ||||||
Inventories,
net
|
450,834 | 425,138 | ||||||
Deferred
income taxes
|
219,875 | 226,095 | ||||||
Other
current assets
|
75,574 | 33,260 | ||||||
Total
current assets
|
3,059,173 | 2,907,504 | ||||||
Marketable
securities
|
725,275 | 663,625 | ||||||
Property,
plant and equipment
|
584,470 | 567,331 | ||||||
Less:
accumulated depreciation
|
238,776 | 217,294 | ||||||
345,694 | 350,037 | |||||||
Other
assets:
|
||||||||
Goodwill
|
14,965 | 14,965 | ||||||
License
agreements, product rights and other intangibles, less accumulated
amortization of $457,614 in September and $421,719 in
March
|
491,248 | 527,787 | ||||||
Deferred
income taxes
|
60,065 | 59,778 | ||||||
Other
assets
|
1,681 | 1,671 | ||||||
Total
other assets
|
567,959 | 604,201 | ||||||
Total
assets
|
$ | 4,698,101 | $ | 4,525,367 | ||||
See
notes to condensed consolidated financial statements.
|
(In
thousands, except for par values)
|
September
30, 2008
(Unaudited)
|
March 31, 2008
|
||||||
Liabilities and
Stockholders' Equity
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 72,695 | $ | 223,720 | ||||
Accrued
expenses
|
538,238 | 387,105 | ||||||
Total
current liabilities
|
610,933 | 610,825 | ||||||
Long-term
liabilities:
|
||||||||
Income
taxes liabilities
|
221,514 | 198,410 | ||||||
Deferred
income taxes
|
809 | 815 | ||||||
222,323 | 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 421,562 shares in
September and 421,421 shares in March
|
42,156 | 42,142 | ||||||
Additional
paid-in capital
|
1,458,025 | 1,434,172 | ||||||
Retained
earnings
|
6,098,499 | 5,611,493 | ||||||
Accumulated
other comprehensive income
|
5,706 | 34,592 | ||||||
Treasury
stock, at cost (120,182 shares in September and 110,014 shares in
March)
|
( 3,739,541 | ) | ( 3,407,082 | ) | ||||
Total
stockholders' equity
|
3,864,845 | 3,715,317 | ||||||
Total
liabilities and stockholders' equity
|
$ | 4,698,101 | $ | 4,525,367 | ||||
See
notes to condensed consolidated financial statements.
|
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
(In
thousands, except per share amounts)
|
September 30,
|
September 30,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Net
sales
|
$ | 925,570 | $ | 842,337 | $ | 1,819,315 | $ | 1,684,953 | ||||||||
Contract
revenue
|
47,210 | 50,313 | 101,363 | 103,690 | ||||||||||||
Interest
income
|
19,194 | 24,932 | 37,424 | 51,670 | ||||||||||||
Other
income
|
532 | 1,378 | 1,248 | 6,921 | ||||||||||||
992,506 | 918,960 | 1,959,350 | 1,847,234 | |||||||||||||
Costs
and expenses:
|
||||||||||||||||
Cost
of sales
|
205,001 | 189,992 | 402,342 | 376,232 | ||||||||||||
Selling,
general and administrative
|
326,261 | 280,439 | 669,215 | 541,767 | ||||||||||||
Research
and development
|
146,357 | 170,738 | 258,469 | 307,646 | ||||||||||||
677,619 | 641,169 | 1,330,026 | 1,225,645 | |||||||||||||
Income
before income tax expense
|
314,887 | 277,791 | 629,324 | 621,589 | ||||||||||||
Income
tax expense
|
70,801 | 52,547 | 142,318 | 128,183 | ||||||||||||
Net
income
|
$ | 244,086 | $ | 225,244 | $ | 487,006 | $ | 493,406 | ||||||||
Net
income per common share:
|
||||||||||||||||
Basic
|
$ | 0.80 | $ | 0.71 | $ | 1.59 | $ | 1.55 | ||||||||
Diluted
|
$ | 0.80 | $ | 0.71 | $ | 1.59 | $ | 1.54 | ||||||||
Weighted
average number of common shares outstanding:
|
||||||||||||||||
Basic
|
304,346 | 315,510 | 305,687 | 317,534 | ||||||||||||
Diluted
|
305,505 | 316,852 | 306,701 | 319,375 | ||||||||||||
See
notes to condensed consolidated financial statements.
|
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
(In
thousands)
|
September 30,
|
September 30,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Net
income
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$ | 244,086 | $ | 225,244 | $ | 487,006 | $ | 493,406 | ||||||||
Other
comprehensive (loss) income
|
( 27,964 | ) | 6,498 | ( 28,886 | ) | 8,477 | ||||||||||
Comprehensive
income
|
$ | 216,122 | $ | 231,742 | $ | 458,120 | $ | 501,883 | ||||||||
See
notes to condensed consolidated financial statements.
|
Six
Months Ended
|
||||||||
(In
thousands)
|
September 30,
|
|||||||
2008
|
2007
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
income
|
$ | 487,006 | $ | 493,406 | ||||
Adjustments
to reconcile net income to net cash provided by operating
activities:
|
||||||||
Depreciation
|
22,754 | 23,075 | ||||||
Amortization
and impairments
|
35,895 | 21,588 | ||||||
Stock-based
compensation expense
|
20,254 | 20,078 | ||||||
Deferred
income tax expense (benefit)
|
5,927 | ( 5,304 | ) | |||||
Foreign
currency transaction gain
|
( 630 | ) | ( 137 | ) | ||||
Net
change in operating assets and liabilities:
|
||||||||
Decrease
(increase) in:
|
||||||||
Accounts
receivable, net
|
22,964 | ( 40,287 | ) | |||||
Inventories,
net
|
( 25,696 | ) | ( 13,161 | ) | ||||
Other
current assets
|
( 42,314 | ) | ( 18,629 | ) | ||||
Other
assets
|
( 10 | ) | 8,382 | |||||
Increase
(decrease) in
|
||||||||
Accounts
payable
|
( 151,025 | ) | 26,977 | |||||
Accrued
expenses
|
151,133 | 60,751 | ||||||
Income
taxes liabilities
|
23,104 | 24,330 | ||||||
Net
cash provided by operating activities
|
549,362 | 601,069 | ||||||
Cash
flows from investing activities:
|
||||||||
Purchase
of property, plant and equipment
|
( 19,240 | ) | ( 17,791 | ) | ||||
Purchase
of marketable securities
|
( 1,247,144 | ) | ( 1,244,988 | ) | ||||
Redemption
of marketable securities
|
1,309,441 | 1,295,045 | ||||||
Net
cash provided by investing activities
|
43,057 | 32,266 | ||||||
Cash
flows from financing activities:
|
||||||||
Net
proceeds from common stock options exercised by employees under stock
option plans
|
3,378 | 24,856 | ||||||
Tax
benefit realized from the exercise of stock options by
employees
|
236 | 5,071 | ||||||
Purchase
of treasury stock
|
( 332,459 | ) | ( 274,804 | ) | ||||
Net
cash used in financing activities
|
( 328,845 | ) | ( 244,877 | ) | ||||
Effect
of exchange rate changes on cash
|
( 26,784 | ) | 7,642 | |||||
Increase
in cash and cash equivalents
|
236,790 | 396,100 | ||||||
Cash
and cash equivalents, beginning of period
|
833,052 | 563,663 | ||||||
Cash
and cash equivalents, end of period
|
$ | 1,069,842 | $ | 959,763 | ||||
Supplemental
disclosures of cash flow information:
|
||||||||
Cash
paid during the period for:
|
||||||||
Income
taxes
|
$ | 135,342 | $ | 104,082 | ||||
See
notes to condensed consolidated financial statements.
|
(In
thousands)
|
September
30, 2008
(Unaudited)
|
March 31, 2008
|
||||||
Trade
|
$ | 326,202 | $ | 377,779 | ||||
Other
|
96,821 | 68,208 | ||||||
$ | 423,023 | $ | 445,987 |
(In
thousands)
|
September
30, 2008
(Unaudited)
|
March 31, 2008
|
||||||
Raw
materials
|
$ | 178,108 | $ | 234,288 | ||||
Work
in process
|
1,711 | 1,360 | ||||||
Finished
goods
|
271,015 | 189,490 | ||||||
$ | 450,834 | $ | 425,138 |
Level
1:
|
Observable
inputs such as quoted prices for identical assets or liabilities in active
markets.
|
|
Level
2:
|
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:
|
Unobservable
inputs that reflect the reporting entity’s own
assumptions.
|
Description
|
Fair
Value at
September 30,
2008
|
Quoted
Prices in Active Markets for Identical Assets
(Level 1)
|
Significant
Other Observable Market Inputs
(Level
2)
|
|||||||||
Money
market accounts
|
$ | 830,263 | $ | 830,263 | ||||||||
Municipal
bonds and notes
|
191,965 | $ | 191,965 | |||||||||
Commercial
paper
|
775,765 | 383,709 | 392,056 | |||||||||
Variable
rate demand notes
|
214,659 | 214,659 | ||||||||||
Floating
rate notes
|
437,271 | 265,387 | 171,884 | |||||||||
Auction
rate securities
|
38,795 | 38,795 |
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Basic
|
304,346 | 315,510 | 305,687 | 317,534 | ||||||||||||
Effect
of assumed conversion of employee stock options and restricted
stock
|
1,159 | 1,342 | 1,014 | 1,841 | ||||||||||||
Diluted
|
305,505 | 316,852 | 306,701 | 319,375 |
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
(In
thousands)
|
September 30,
|
September 30,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Central
nervous system
|
$ | 833,112 | $ | 756,969 | $ | 1,643,432 | $ | 1,504,477 | ||||||||
Cardiovascular
|
19,593 | 6,849 | 29,408 | 15,268 | ||||||||||||
Other
|
72,865 | 78,519 | 146,475 | 165,208 | ||||||||||||
$ | 925,570 | $ | 842,337 | $ | 1,819,315 | $ | 1,684,953 |
|
·
|
In
May 2008, we filed a supplemental New Drug Application (or sNDA) for
Lexapro for the additional indication of adolescent
depression. The filing was based on 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.
|
|
·
|
Regarding
nebivolol (Bystolic), we plan to file an sNDA in early calendar 2009 for a
new indication of congestive heart failure based on the results of the
Phase III Seniors study.
|
|
·
|
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. In October 2008, the FDA advised us and our partner
Cypress Bioscience, Inc. (or Cypress) that is was not able to take final
action by the scheduled Prescription Drug User Fee Act action date of
October 18, 2008. The FDA has not requested any additional
information from Forest or Cypress but did indicate that a clinical data
question related to the NDA submission required
confirmation. The FDA further indicated that its assessment
could be completed in a matter of weeks, but could not confirm specific
timing. The FDA could not provide further information regarding
the reason for the delay. We and Cypress continue to plan for a
product launch meeting in the first quarter of calendar
2009. We also expect results from a third randomized Phase III
study in late calendar 2008.
|
|
·
|
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 have initiated 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 50/50 partnership with
Ironwood to co-develop and co-market the compound
linaclotide. 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
study 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 the IBS-C
trials are anticipated to begin in January
2009.
|
|
·
|
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 and file an NDA for this new once-daily
formulation.
|
|
·
|
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 (RGH-188) and related compounds, being developed as
an atypical antipsychotic for the treatment of schizophrenia, bipolar
mania and other psychiatric conditions. 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. 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.
|
|
·
|
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.
|
September 30, 2008
|
September 30, 2007
|
|||||||
Beginning
balance
|
$ | 229,681 | $ | 208,063 | ||||
Provision
for rebates
|
247,957 | 203,261 | ||||||
Changes
in estimates
|
||||||||
Settlements
|
( 233,276 | ) | ( 175,888 | ) | ||||
14,681 | 27,373 | |||||||
Provision
for returns
|
13,720 | 16,406 | ||||||
Changes
in estimates
|
||||||||
Settlements
|
( 11,904 | ) | ( 17,900 | ) | ||||
1,816 | ( 1,494 | ) | ||||||
Provision
for chargebacks and discounts
|
151,700 | 168,801 | ||||||
Changes
in estimates
|
( 7,700 | ) | ||||||
Settlements
|
( 153,747 | ) | ( 172,020 | ) | ||||
( 2,047 | ) | ( 10,919 | ) | |||||
Ending
balance
|
$ | 244,131 | $ | 223,023 |
Period
|
Total number of shares
purchased (1)
|
Average
price paid per share
|
Total
number of shares purchased as part of publicly announced plans or
programs
|
Maximum
number of shares that may yet be purchased under the
program
|
|||||
7/1/08
through
7/31/08
|
-
|
-
|
-
|
9,156,400
|
|||||
8/1/08
through
8/31/08
|
-
|
-
|
-
|
9,156,400
|
|||||
9/1/08
through
9/30/08
|
3,503,100
|
$28.81
|
3,503,100
|
5,653,300
|
Matter
|
For
|
Against
|
Abstain
|
Withhold
authority
|
Broker
non-votes
|
|
Election
of Directors:
|
||||||
Howard
Solomon
|
264,011,723
|
11,400,904
|
||||
Lawrence
S. Olanoff, M.D., Ph.D.
|
264,906,938
|
10,505,689
|
||||
Nesli
Basgoz, M.D.
|
267,758,788
|
7,653,839
|
||||
William
J. Candee, III
|
259,567,444
|
15,845,183
|
||||
George
S. Cohan
|
265,866,448
|
9,546,179
|
||||
Dan
L. Goldwasser
|
266,013,808
|
9,398,819
|
||||
Kenneth
E. Goodman
|
259,102,274
|
16,310,353
|
||||
Lester
B. Salans, M.D.
|
267,624,601
|
7,788,026
|
||||
Adoption
of the Amended and Restated Certificate of Incorporation
|
232,812,374
|
40,197,915
|
2,402,338
|
|||
Ratification
of Independent Registered Public Accounting Firm
|
271,642,547
|
1,486,698
|
2,283,381
|
Item
6.
|
Exhibits
|
|
Amended
and Restated Certificate of Incorporation of Forest Laboratories,
Inc.
|
||
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
|