UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
__________________________________________
(Mark
One)
x
|
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the Quarterly Period Ended December 31, 2009
o
|
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period from to
Commission
File No. 1-5438
FOREST LABORATORIES,
INC.
(Exact
name of registrant as specified in its charter)
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)
|
(212)
421-7850
(Registrant's
telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x No o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such
files). Yes x No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of "large accelerated filer," "accelerated filer" and "smaller
reporting company" in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer x
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company o
|
|
|
(Do
not check if a smaller reporting company)
|
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No x
Number of
shares outstanding of Registrant's Common Stock as of February 8, 2010:
302,371,127
(Quick Links)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXHIBIT 101.INS
|
|
EXHIBIT 101.SCH
|
|
EXHIBIT 101.PRE
|
|
EXHIBIT 101.CAL
|
|
EXHIBIT
101.LAB
|
PART I - FINANCIAL
INFORMATION
FOREST LABORATORIES, INC. AND
SUBSIDIARIES
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
(In
thousands)
|
|
December
31, 2009
(Unaudited)
|
|
|
March 31, 2009
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
(including cash equivalent investments of $1,837,190 in December and
$1,337,871 in March)
|
|
$ |
1,838,092 |
|
|
$ |
1,338,905 |
|
Marketable
securities
|
|
|
1,405,196 |
|
|
|
1,242,017 |
|
Accounts
receivable, less allowance for doubtful accounts of $18,313 in December
and $18,511 in March
|
|
|
506,025 |
|
|
|
449,444 |
|
Inventories,
net
|
|
|
465,918 |
|
|
|
393,527 |
|
Deferred
income taxes
|
|
|
224,263 |
|
|
|
217,811 |
|
Other
current assets
|
|
|
119,919 |
|
|
|
144,250 |
|
Total
current assets
|
|
|
4,559,413 |
|
|
|
3,785,954 |
|
|
|
|
|
|
|
|
|
|
Marketable
securities and investments
|
|
|
630,451 |
|
|
|
449,793 |
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment
|
|
|
601,224 |
|
|
|
586,039 |
|
Less:
accumulated depreciation
|
|
|
274,177 |
|
|
|
240,104 |
|
|
|
|
327,047 |
|
|
|
345,935 |
|
Other
assets:
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
14,965 |
|
|
|
14,965 |
|
License
agreements, product rights and other intangibles, less accumulated
amortization of $499,810 in December and $474,960 in March
|
|
|
473,557 |
|
|
|
497,897 |
|
Deferred
income taxes
|
|
|
99,365 |
|
|
|
100,758 |
|
Other
assets
|
|
|
1,343 |
|
|
|
1,506 |
|
Total
other assets
|
|
|
589,230 |
|
|
|
615,126 |
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
6,106,141 |
|
|
$ |
5,196,808 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed
consolidated financial statements. |
|
|
|
|
|
|
|
|
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
(In
thousands, except for par values)
|
|
December
31, 2009
(Unaudited)
|
|
|
March 31, 2009
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders'
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
131,923 |
|
|
$ |
117,192 |
|
Accrued
expenses
|
|
|
787,840 |
|
|
|
700,636 |
|
Total
current liabilities
|
|
|
919,763 |
|
|
|
817,828 |
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities:
|
|
|
|
|
|
|
|
|
Income
tax liabilities
|
|
|
340,260 |
|
|
|
264,389 |
|
|
|
|
|
|
|
|
|
|
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 424,068 shares in
December and 422,268 shares in March
|
|
|
42,406 |
|
|
|
42,227 |
|
Additional
paid-in capital
|
|
|
1,550,756 |
|
|
|
1,491,239 |
|
Retained
earnings
|
|
|
7,039,028 |
|
|
|
6,379,236 |
|
Accumulated
other comprehensive loss
|
|
|
( 2,684 |
) |
|
|
( 47,145 |
) |
Treasury
stock, at cost (121,700 shares in December and 120,653 shares in
March)
|
|
|
( 3,783,388 |
) |
|
|
( 3,750,966 |
) |
Total
stockholders' equity
|
|
|
4,846,118 |
|
|
|
4,114,591 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
|
$ |
6,106,141 |
|
|
$ |
5,196,808 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed
consolidated financial statements. |
|
|
|
|
|
|
|
|
FOREST LABORATORIES, INC. AND
SUBSIDIARIES
Condensed
Consolidated Statements of Income
(Unaudited)
|
|
Three
Months Ended
|
|
|
Nine
Months Ended
|
|
(In
thousands, except per share amounts)
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$ |
997,002 |
|
|
$ |
920,013 |
|
|
$ |
2,907,958 |
|
|
$ |
2,739,329 |
|
Contract
revenue
|
|
|
55,755 |
|
|
|
52,433 |
|
|
|
154,053 |
|
|
|
153,796 |
|
Interest
income
|
|
|
7,302 |
|
|
|
24,235 |
|
|
|
28,913 |
|
|
|
61,658 |
|
Other
income
|
|
|
4,621 |
|
|
|
1,274 |
|
|
|
45,841 |
|
|
|
2,522 |
|
|
|
|
1,064,680 |
|
|
|
997,955 |
|
|
|
3,136,765 |
|
|
|
2,957,305 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs
and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
|
247,648 |
|
|
|
206,654 |
|
|
|
685,553 |
|
|
|
608,995 |
|
Selling,
general and administrative
|
|
|
306,962 |
|
|
|
289,968 |
|
|
|
943,693 |
|
|
|
959,184 |
|
Research
and development
|
|
|
233,609 |
|
|
|
279,051 |
|
|
|
643,814 |
|
|
|
537,520 |
|
|
|
|
788,219 |
|
|
|
775,673 |
|
|
|
2,273,060 |
|
|
|
2,105,699 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
before income tax expense
|
|
|
276,461 |
|
|
|
222,282 |
|
|
|
863,705 |
|
|
|
851,606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
tax expense
|
|
|
66,229 |
|
|
|
34,307 |
|
|
|
203,913 |
|
|
|
176,625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
210,232 |
|
|
$ |
187,975 |
|
|
$ |
659,792 |
|
|
$ |
674,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
0.69 |
|
|
$ |
0.62 |
|
|
$ |
2.18 |
|
|
$ |
2.21 |
|
Diluted
|
|
$ |
0.69 |
|
|
$ |
0.62 |
|
|
$ |
2.17 |
|
|
$ |
2.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
303,348 |
|
|
|
302,163 |
|
|
|
303,097 |
|
|
|
304,813 |
|
Diluted
|
|
|
303,845 |
|
|
|
302,791 |
|
|
|
303,590 |
|
|
|
305,676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
notes to condensed consolidated financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Comprehensive Income
(Unaudited)
|
|
Three
Months Ended
|
|
|
Nine
Months Ended
|
|
(In
thousands)
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
210,232 |
|
|
$ |
187,975 |
|
|
$ |
659,792 |
|
|
$ |
674,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
currency translation (losses) gains
|
|
|
( 1,996 |
) |
|
|
( 7,299 |
) |
|
|
9,812 |
|
|
|
( 25,112 |
) |
Pension
liability adjustment
|
|
|
( 44 |
) |
|
|
|
|
|
|
( 11,602 |
) |
|
|
|
|
Unrealized
gains (losses) on securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
holding gains (losses) arising during the period, net of
tax
|
|
|
829 |
|
|
|
( 12,775 |
) |
|
|
46,251 |
|
|
|
( 23,848 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive (loss) income
|
|
|
(1,211 |
) |
|
|
( 20,074 |
) |
|
|
44,461 |
|
|
|
( 48,960 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
income
|
|
$ |
209,021 |
|
|
$ |
167,901 |
|
|
$ |
704,253 |
|
|
$ |
626,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
notes to condensed consolidated financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FOREST LABORATORIES, INC.
AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
|
Nine
Months Ended
|
|
(In
thousands)
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
income
|
|
$ |
659,792 |
|
|
$ |
674,981 |
|
Adjustments
to reconcile net income to net cash provided by operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
33,844 |
|
|
|
32,383 |
|
Amortization
and impairments
|
|
|
34,903 |
|
|
|
44,275 |
|
Stock-based
compensation expense
|
|
|
34,177 |
|
|
|
31,516 |
|
Deferred
income tax benefit
|
|
|
( 5,059 |
) |
|
|
( 24,892 |
) |
Foreign
currency transaction gain
|
|
|
( 180 |
) |
|
|
( 1,392 |
) |
Net
change in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease
(increase) in:
|
|
|
|
|
|
|
|
|
Accounts
receivable, net
|
|
|
( 56,581 |
) |
|
|
17,095 |
|
Inventories,
net
|
|
|
( 72,391 |
) |
|
|
28,786 |
|
Other
current assets
|
|
|
24,331 |
|
|
|
( 24,566 |
) |
Other
assets
|
|
|
163 |
|
|
|
75 |
|
Increase
(decrease) in:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
14,731 |
|
|
|
( 162,313 |
) |
Accrued
expenses
|
|
|
87,204 |
|
|
|
155,431 |
|
Income
tax liabilities
|
|
|
75,871 |
|
|
|
59,570 |
|
Net
cash provided by operating activities
|
|
|
830,805 |
|
|
|
830,949 |
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchase
of property, plant and equipment
|
|
|
( 24,427 |
) |
|
|
( 33,026 |
) |
Purchase
of marketable securities and investments
|
|
|
( 1,938,564 |
) |
|
|
( 1,646,523 |
) |
Redemption
of marketable securities
|
|
|
1,594,727 |
|
|
|
1,718,054 |
|
Net
cash (used in) provided by investing activities
|
|
|
( 368,264 |
) |
|
|
38,505 |
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Net
proceeds from common stock options exercised by employees under stock
option plans
|
|
|
16,919> |
|
|
|
10,629 |
|
Tax
benefit related to stock-based compensation
|
|
|
8,600 |
|
|
|
2,446 |
|
Purchase
of treasury stock
|
|
|
( 32,422 |
) |
|
|
( 343,860 |
) |
Net
cash used in financing activities
|
|
|
( 6,903 |
) |
|
|
( 330,785 |
) |
|
|
|
|
|
|
|
|
|
Effect
of exchange rate changes on cash
|
|
|
43,549 |
|
|
|
( 44,770 |
) |
Increase
in cash and cash equivalents
|
|
|
499,187 |
|
|
|
493,899 |
|
Cash
and cash equivalents, beginning of period
|
|
|
1,338,905 |
|
|
|
833,052 |
|
Cash
and cash equivalents, end of period
|
|
$ |
1,838,092 |
|
|
$ |
1,326,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
Cash
paid for income taxes
|
|
$ |
137,412 |
|
|
$ |
141,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed
consolidated financial statements. |
|
|
|
|
|
|
|
|
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
(Unaudited)
1. Basis
of Presentation:
The
accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with U.S. generally accepted accounting principles (or
GAAP) for interim financial information and with the instructions to Form 10-Q
and Accounting Standards Codification (or ASC) 270-10. Accordingly,
they do not include all of the information and footnotes required by GAAP for
complete financial statements. In the opinion of Management, all
adjustments (consisting of only normal recurring accruals) considered necessary
for a fair presentation have been included and the Company has evaluated
subsequent events up to the date of this filing. Certain amounts as
previously reported have been reclassified to conform to current year
classifications. Operating results for the nine-month period ended
December 31, 2009 are not necessarily indicative of the results that may be
expected for the year ending March 31, 2010. For further information
refer to the consolidated financial statements and footnotes thereto
incorporated by reference in the Company's Annual Report on Form 10-K for
the year ended March 31, 2009.
During
the quarter ended September 30, 2009 the Company adopted ASC 105, “The FASB
Accounting Standards Codification and the Hierarchy of Generally Accepted
Accounting Principles”. This establishes the Financial Accounting
Standards Board (or FASB) Accounting Standards Codification as the only source
of authoritative accounting principles recognized by the FASB to be applied in
the preparation of financial statements in conformity with GAAP.
During
the quarter ended September 30, 2009 the Company adopted ASC 605-25, “Revenue
Arrangements with Multiple Deliverables”. This statement provides
principles for allocation of consideration among its multiple-elements, allowing
more flexibility in identifying and accounting for separate deliverables under
an arrangement. The Company has elected early adoption of this
standard which did not have a material effect on the Company’s condensed
consolidated financial statements.
2. Accounts
Receivable (In
thousands):
Accounts
receivable, net, consists of the following:
|
|
December
31, 2009
(Unaudited)
|
|
|
March 31, 2009
|
|
|
|
|
|
|
|
|
Trade
|
|
$ |
415,418 |
|
|
$ |
351,697 |
|
Other
|
|
|
90,607 |
|
|
|
97,747 |
|
|
|
$ |
506,025 |
|
|
$ |
449,444 |
|
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
3. Inventories
(In
thousands):
Inventories,
net of reserves for obsolescence, consist of the following:
|
|
December
31, 2009
(Unaudited)
|
|
|
March 31, 2009
|
|
|
|
|
|
|
|
|
Raw
materials
|
|
$ |
179,932 |
|
|
$ |
126,292 |
|
Work
in process
|
|
|
1,197 |
|
|
|
982 |
|
Finished
goods
|
|
|
284,789 |
|
|
|
266,253 |
|
|
|
$ |
465,918 |
|
|
$ |
393,527 |
|
4. Fair Value
Measurements (In
thousands):
The
following table presents the level within the fair value hierarchy at which the
Company’s financial assets are carried at fair value and measured on a recurring
basis:
Description
|
|
Fair
value at
December 31, 2009
|
|
|
Quoted
prices in active markets for identical assets
(Level 1)
|
|
|
Significant
other observable market inputs
(Level 2)
|
|
|
Unobservable
market
inputs
(Level 3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money
market accounts
|
|
$ |
1,724,609 |
|
|
$ |
1,724,609 |
|
|
|
|
|
|
|
Municipal
bonds and notes
|
|
|
327,158 |
|
|
|
|
|
|
$ |
327,158 |
|
|
|
|
Commercial
paper
|
|
|
1,165,455 |
|
|
|
543,059 |
|
|
|
622,396 |
|
|
|
|
Variable
rate demand notes
|
|
|
138,884 |
|
|
|
|
|
|
|
138,884 |
|
|
|
|
|
Floating
rate notes
|
|
|
361,007 |
|
|
|
|
|
|
|
361,007 |
|
|
|
|
|
Auction
rate securities
|
|
|
36,539 |
|
|
|
|
|
|
|
|
|
|
$ |
36,539 |
|
As of
December 31, 2009, the Company has determined the value of the auction rate
securities portfolio based upon a discounted cash flow model, which has been
unchanged since the beginning of this fiscal period.
On April
1, 2009, the Company adopted the provisions of ASC 820-10-65, “Fair Value
Measurements and Disclosures” for non-financial assets and non-financial
liabilities. This statement did not have a material effect on the
Company’s condensed consolidated financial statements.
The
majority of the Company’s non-financial assets and liabilities are not required
to be carried at fair value on a recurring basis. However, the Company is
required on a non-recurring basis to use fair value measurements when analyzing
asset impairment as it relates to license agreements, product rights and other
intangible assets and long-lived assets. The carrying amount of cash,
accounts receivable and accounts payable and other short-term financial
instruments approximate their fair value due to their short-term
nature.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
5. Marketable Securities
(In
thousands):
Available-for-sale
debt securities consist of the following:
|
|
December 31,
2009
|
|
|
|
Estimated
fair value
|
|
|
Gains
in accumulated other comprehensive income
|
|
|
Losses
in accumulated other comprehensive income
|
|
Current:
|
|
|
|
|
|
|
|
|
|
Variable
rate demand notes
|
|
$ |
138,884 |
|
|
|
|
|
|
|
Municipal
bonds and notes
|
|
|
186,789 |
|
|
$ |
959 |
|
|
|
|
Commercial
paper
|
|
|
1,009,009 |
|
|
|
1,448 |
|
|
|
|
Floating
rate notes
|
|
|
70,514 |
|
|
|
|
|
|
$ |
( 516 |
) |
Total
current securities
|
|
|
1,405,196 |
|
|
|
2,407 |
|
|
|
( 516 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncurrent:
|
|
|
|
|
|
|
|
|
|
|
|
|
Municipal
bonds and notes
|
|
|
140,369 |
|
|
|
493 |
|
|
|
|
|
Commercial
paper
|
|
|
146,450 |
|
|
|
89 |
|
|
|
|
|
Auction
rate notes
|
|
|
36,539 |
|
|
|
|
|
|
|
|
|
Floating
rate notes
|
|
|
290,493 |
|
|
|
|
|
|
|
( 21,441 |
) |
Total
noncurrent securities
|
|
|
613,851 |
|
|
|
582 |
|
|
|
( 21,441 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
available-for-sale debt securities
|
|
$ |
2,019,047 |
|
|
$ |
2,989 |
|
|
$ |
(21,957 |
) |
Proceeds
from the sales of available-for-sale debt securities was $1,594,727 for the nine
months ended December 31, 2009. Gross realized gains on those sales
for the nine months ended December 31, 2009 was
$11,603. For purposes of determining gross realized gains and losses,
the cost of the securities is based on average cost. Net unrealized
holding losses on available-for-sale debt securities in the amount of $18,968
for the nine months ended December 31, 2009 has been included in Stockholders’
equity: Accumulated other comprehensive income (loss). The
preceding table does not include the Company’s $16,600 investment in Ironwood
Pharmaceuticals, Inc., which is held at cost and described in Note 6 to the
Condensed Consolidated Financial Statements.
Contractual
maturities of available-for-sale debt securities at December 31, 2009, are as
follows:
|
|
Estimated
fair value
|
|
Within
one year
|
|
$ |
1,405,196 |
|
1-5
years
|
|
|
513,489 |
|
5-10
years
|
|
|
52,388 |
|
After
10 years
|
|
|
47,974 |
|
|
|
$ |
2,019,047 |
|
Actual
maturities may differ from contractual maturities because some borrowers have
the right to call or prepay obligations with or without call
penalties.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
The
Company currently invests funds in variable rate demand notes that have major
bank liquidity agreements, municipal bonds and notes, commercial paper including
money market instruments, auction rate securities and bank floating rate
notes. Certain securities are subject to a hard-put option(s) where
the principal amount is contractually assured by the issuer and any resistance
to the exercise of these options would be deemed as a default by the
issuer. Such a potential default would be reflected in the issuer’s
respective credit rating, for which the Company maintains investment grade
requirements pursuant to its corporate investment guidelines. While
the Company believes its investments that have net unrealized losses are
temporary, further declines in the value of these investments may be deemed
other-than-temporary if the credit and capital markets were to deteriorate in
future periods. The Company does not have the intent to sell its investments and
it is more likely than not that the Company will not have to sell the
investments before the recovery of its cost basis. Therefore, the
Company does not consider these investments to be other-than-temporarily
impaired and will continue to monitor global market conditions to minimize the
uncertainty of impairments in future periods.
6. License and
Collaboration Agreements (In thousands):
In
December 2009, the Company entered into a license agreement with Almirall, S.A.
(or Almirall) to develop, market and distribute LAS100977 in the United
States. LAS100977 is Almirall’s inhaled once-daily administered
long-acting beta2 agonist that will be developed in combination with an
undisclosed corticosteroid for the treatment of asthma and chronic obstructive
pulmonary disease (COPD). Under the terms of the agreement the
Company made a $75,000 upfront payment to Almirall which was recorded to
research and development expense and may become obligated to pay future
milestone and sales based royalty payments. The Company will assume
responsibility for the United States regulatory approval and
commercialization.
In
December 2009, the Company entered into an agreement with AstraZeneca AB (or
AstraZeneca) pursuant to which, following the completion of AstraZeneca’s
acquisition of Novexel, SA (or Novexel), the Company’s prior agreement with
Novexel will be amended to grant the Company additional rights to NXL104,
including worldwide rights (other than Japan) to the combination of NXL104 with
ceftaroline and rights in the United States and Mexico to combinations of NXL104
with other compounds, including the antibiotic ceftazidime. NXL104 is
Novexel’s novel intravenous beta-lactamase inhibitor designed to be
co-administered with select antibiotics to enhance their spectrum of activity
and counteract bacterial resistance. Under the terms of the agreement
and following the completion of AstraZeneca’s acquisition of Novexel, the
Company will pay Novexel $210,000 plus certain additional costs for the
additional rights to NXL104 which will be recorded to research and development
expense. In addition, the transaction eliminates all future milestone payments
and royalty payments which the Company would have owed Novexel under the
original license. The transaction is expected to close during the Company’s
fourth quarter of fiscal 2010. The Company may also be obligated to
pay half of certain future development milestones in connection with the
transaction.
In August
2009, the Company entered into a license agreement with Nycomed GmbH (or
Nycomed) to develop and commercialize Daxas® (roflumilast) in the United
States. Daxas is a proprietary selective phosphodiesterase 4 (PDE4)
enzyme inhibitor for oral administration developed by Nycomed for the treatment
of chronic obstructive pulmonary disease. Under the terms of the
agreement, the Company made an upfront payment to Nycomed of $100,000 which was
recorded to research and development expense. The Company may be
obligated to make payments to Nycomed for future development and sales
milestones and royalties on Daxas sales. The Company may also be
responsible for certain development expenses incurred prior to FDA approval. An
NDA for Daxas was filed with the FDA in July 2009.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
The
Company also entered into a license agreement with AstraZeneca UK Limited (or
AstraZeneca) in August 2009, pursuant to which AstraZeneca will co-develop and
commercialize ceftaroline worldwide excluding the United States, Canada and
Japan. Ceftaroline is the Company’s next generation, broad-spectrum,
hospital-based injectable cephalosporin being investigated for the treatment of
complicated skin and skin structure infections (cSSSI) and community acquired
bacterial pneumonia (CABP). Under the terms of the agreement, the
Company received an upfront payment of $40,000 which was recorded to other
income. AstraZeneca may be obligated to pay the Company milestones
and royalties based on future sales of ceftaroline, including the
ceftaroline/NXL104 combination.
Effective
April 1, 2009 the Company implemented ASC 808-10 “Collaborative Arrangements”,
which prescribes that certain transactions between collaborators be recorded in
the income statement on either a gross or net basis, depending on the
characteristics of the collaboration relationship, and provides for enhanced
disclosure of collaborative relationships.
These
collaborations are contractual agreements with third parties consisting of a
joint operating activity involving the research and development, manufacturing
and marketing of a product. These collaboration agreements are profit
sharing in nature and consequently both the Company and its partners are active
participants and are subject to significant risks and rewards. These
collaborative arrangements generally require the Company to make milestone and
royalty payments based upon the results of specific development or regulatory
objectives and future sales, if any. These agreements also include
provisions for reimbursement of certain expenses between the Company and its
partners. The Company has entered into several other license
agreements which are not profit sharing in nature and accordingly do not qualify
as collaboration agreements as defined by ASC 808-10.
Two of
the Company’s agreements qualify as collaboration agreements under ASC
808-10: In October 2008, the Company entered into a collaboration
agreement with Phenomix Corporation (or Phenomix) to co-develop and co-promote
dutogliptin, Phenomix’ proprietary orally administered, small molecule
dipeptidyl-peptidase-4 (DPP-4) inhibitor being developed for the treatment of
Type II diabetes. The Company made a $75,000 upfront payment to
Phenomix in fiscal 2009, which was recorded to research and development
expense. In September 2007, the Company entered into a collaboration
agreement with Ironwood to co-develop and co-market Ironwood’s first-in-class
compound linaclotide, currently being investigated for the treatment of
constipation-predominant irritable bowel syndrome and chronic
constipation. Under the terms of the agreement, in fiscal 2008 the
Company paid Ironwood a $70,000 upfront licensing fee which was recorded to
research and development expense. During the September 2009 quarter,
the Company paid Ironwood $45,000 in development milestones, of which $28,400
was charged to research and development expense and $16,600 was recorded as a
preferred equity investment in Ironwood. These products have not yet
been approved by the FDA.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
7. Net Income Per
Share (In
thousands):
A
reconciliation of shares used in calculating basic and diluted net income per
share follows:
|
|
Three
Months Ended
|
|
|
Nine
Months Ended
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Basic
|
|
|
303,348 |
|
|
|
302,163 |
|
|
|
303,097 |
|
|
|
304,813 |
|
Effect
of assumed conversion of employee stock options
|
|
|
497 |
|
|
|
628 |
|
|
|
493 |
|
|
|
863 |
|
Diluted
|
|
|
303,845 |
|
|
|
302,791 |
|
|
|
303,590 |
|
|
|
305,676 |
|
Options
to purchase approximately 17,550 shares of common stock at exercise prices
ranging from $22.19 to $76.66 per share and options to purchase approximately
17,731 shares of common stock at exercise prices ranging from $20.55 to $76.66
that were outstanding during a portion of the three and nine-month periods ended
December 31, 2009, respectively, were not included in the computation of diluted
net income per share because they were anti-dilutive. These options
expire through 2019. Options to purchase approximately 17,442 shares
of common stock at exercise prices ranging from $24.12 to $76.66 per share and
options to purchase approximately 15,774 shares of common stock at exercise
prices ranging from $24.12 to $76.66 that were outstanding during a portion of
the three and nine-month periods ended December 31, 2008, respectively, were not
included in the computation of diluted net income per share because they were
anti-dilutive. These options expire through 2018.
The above
references to earnings per share are in conformity with ASC 260-10-45 “Earnings
Per Share”. The Company adopted ASC 260-10-45 on April 1, 2009. The
application of ASC 260-10-45 did not have a material effect on the Company’s
earnings per share for the three and nine-month periods ended December 31, 2009
and 2008.
8. Stock-Based
Compensation (In
thousands):
In August
2007 the stockholders of the Company voted to adopt the 2007 Equity Incentive
Plan (or the 2007 Plan) which replaces and supersedes all prior stock option
plans. Under the 2007 Plan, 13,950 shares were authorized to be issued to
employees of the Company and its subsidiaries at prices not less than the fair
market value of the common stock at the date of grant. The 2007 Plan
provides for the granting of incentive and nonqualified stock options,
restricted stock, stock appreciation rights and stock equivalent units.
These awards generally vest in three to five years. Stock option grants
may be exercisable for up to ten years from the date of issuance. As of
December 31, 2009, 2,217 shares were available for grant.
Compensation
expense of $11,895 ($9,551 net of tax) and $34,177 ($27,743 net of tax) was
recorded for the three and nine-month periods ended December 31, 2009,
respectively. For the three and nine-month periods ended December 31,
2008, compensation expense of $11,262 ($9,270 net of tax) and $31,516 ($26,314
net of tax) was recorded. This expense was charged to cost of sales,
selling, general and administrative and research and development expense, as
appropriate.
The
weighted average number of diluted common shares outstanding is reduced by the
treasury stock method which, in accordance with the provisions of ASC 718-10
“Compensation-Stock Compensation” takes into consideration the compensation cost
attributed to future services not yet recognized.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
9. Business Segment
Information (In
thousands):
The
Company operates in only one segment. Below is a breakdown of net
sales by therapeutic class:
|
|
Three
Months Ended
|
|
|
Nine
Months Ended
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Central
nervous system
|
|
$ |
885,778 |
|
|
$ |
829,384 |
|
|
$ |
2,580,758 |
|
|
$ |
2,472,816 |
|
Cardiovascular
|
|
|
57,553 |
|
|
|
25,501 |
|
|
|
151,350 |
|
|
|
54,909 |
|
Other
|
|
|
53,671 |
|
|
|
65,128 |
|
|
|
175,850 |
|
|
|
211,604 |
|
|
|
$ |
997,002 |
|
|
$ |
920,013 |
|
|
$ |
2,907,958 |
|
|
$ |
2,739,329 |
|
10. Long-Term
Debt:
On
December 7, 2007, the Company established a $500 million revolving credit
facility for the purpose of providing additional financial liquidity for the
financing of business development and corporate strategic
initiatives. The facility can be increased up to $750 million based
upon an agreement with the participating lenders and expires on December 7,
2012. As of February 8, 2010, the Company has not drawn any funds
from the available credit. The utilization of the revolving credit
facility is subject to the adherence to certain financial covenants such as
leverage and interest coverage ratios.
11. Income Taxes
(In
thousands):
The
Company’s income tax returns for fiscal years prior to 1999 in most
jurisdictions and prior to 2003 in Ireland are no longer subject to review as
such fiscal years are generally closed. Tax authorities in various
jurisdictions are in the process of reviewing the Company’s income tax returns
for various post-1999 fiscal years, including the Internal Revenue Service (or
IRS), which concluded its examination of the Company’s U.S. federal income tax
returns for fiscal years 2002 and 2003.
In
connection with that examination the Company agreed with an assessment related
to intercompany transfer pricing. Such assessment resulted in
additional U.S. federal and state corporation tax within previously established
tax reserves and did not have a material impact on the Company’s results of
operations.
Fiscal
years 2004, 2005 and 2006 are currently under review by the IRS. It
is unlikely that the outcome will be determined within the next 12
months. Potential claims for years under review could be
material.
The
Company’s continuing practice is to recognize net interest related to income tax
matters in income tax expense. As of December 31, 2009, the Company
had accrued an additional $16,545 in interest for a total of $46,442 related to
the resolution of various income tax matters.
The
Company’s effective tax rate was 24.0% and 23.6% for the three and nine-month
periods ended December 31, 2009, as compared to 15.4% and 20.7% for the same
periods last year. The increase was primarily due to the effect of the
Company’s upfront license payment to Almirall and other tax matters compared to
the impact of the termination of the co-promotion agreement for Azor® and other
tax matters in the same period last year. Effective tax rates may be
affected by ongoing tax audits.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
12. Legal
Proceedings (In
thousands):
In July 2009,
the Company along with its licensing partner H. Lundbeck A/S (or Lundbeck)
entered into a settlement agreement with Caraco Pharmaceutical Laboratories (or
Caraco) regarding patent infringement disputes relating to
Lexapro. Pursuant to the settlement, the Company and Lundbeck will
provide licenses to Caraco for any patents related to Lexapro with respect to
the marketing of Caraco's generic version of the product as of the date any
third party generic that has properly received final approval from the FDA
enters the market, other than an authorized generic or the first filer with
Hatch-Waxman related exclusivity. In addition, Caraco will take over
the commercialization and sale of several products from Forest's Inwood business
in consideration for royalties on net sales of those products and Caraco’s
parent Sun Pharma will license to Lundbeck on a worldwide basis certain patent
applications related to the synthesis of escitalopram and
citalopram. In connection with the settlement, the Company incurred a
$20,000 charge during the quarter ended September 30, 2009 which was recorded to
selling, general and administrative expense. The Company and Lundbeck
reimbursed certain of Caraco's legal costs in connection with these patent
litigations.
As
previously disclosed, the United States Attorney’s Office for the District of
Massachusetts (USAO) is investigating various potential violations of civil and
criminal laws in connection with the Company’s marketing of Celexa and Lexapro,
as well as in connection with the manufacturing and marketing of
Levothroid. In respect of these matters, the Company recorded a
reserve of $170,000 during fiscal 2009. In May 2009, Forest reached
an agreement in principle with the USAO and the Civil Division of the U.S.
Department of Justice (DOJ) to settle civil claims arising from these
investigations, including (a) claims on behalf of the U.S. government asserted
in the two qui tam
lawsuits previously disclosed and (b) related claims by states who are members
of the National Medicaid Fraud Control Unit, which has been working with the
USAO and the DOJ. The amount of the settlement subject to the
agreement in principle falls within the $170,000 reserve in respect of these
matters recorded in fiscal 2009. Consummation of the agreement in
principle is subject to the negotiation and finalization of appropriate
implementing agreements, including civil settlement agreements and a corporate
integrity agreement. The negotiation of these agreements is ongoing,
and until they are finalized, there can be no assurance that a negotiated
resolution of these matters can be achieved or that any such resolution will not
require payments in excess of the expense recorded in fiscal 2009. In
addition, the agreement in principle discussed above does not resolve the
government’s ongoing investigation into potential criminal law violations
related to Celexa, Lexapro and Levothroid. The Company is continuing
to cooperate with this investigation and to discuss these issues with the
government.
With
respect to the litigation brought by the Company and its licensing partner Merz
Pharma GmbH & Co. KgaA (or Merz) against several companies who had notified
the Company that they have filed ANDA’s with the FDA seeking to obtain approval
to market generic versions of Namenda, the Company and Merz have entered into
settlement agreements with Amneal Pharmaceuticals, LLC, Apotex Inc., Cobalt
Laboratories, Inc., Dr. Reddy’s Laboratories, Inc., Lupin Pharmaceuticals,
Inc., Sun India Pharmaceutical Industries, Ltd., Teva Pharmaceuticals
USA, Inc., Upsher-Smith Laboratories, Inc., Wockhardt Limited, and related
companies and subsidiaries thereof in such patent infringement litigation
captioned Forest Laboratories,
Inc. et al. v. Cobalt Laboratories, Inc. et al. and pending in the U.S.
District Court for the District of Delaware. These settlement
agreements do not settle Forest and Merz’s patent infringement litigation
against Mylan Pharmaceuticals Inc., and related companies and subsidiaries
thereof, that is pending in the District of Delaware, or Forest and Merz’s
patent infringement litigation against Orchid Chemicals & Pharmaceuticals
Ltd. and Orgenus Pharma, Inc. that is pending in the U.S. District Court for the
District of New Jersey. A trial in the Delaware litigation is
currently scheduled for April 2010. No trial has been scheduled in
the New Jersey litigation.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements (Continued)
(Unaudited)
On
October 15, 2009, in the case captioned Infosint S.A. v. H. Lundbeck A/S et al.
and described in the Company’s Annual Report on Form 10-K for the fiscal year
ended March 31, 2009, a jury in the U.S. District Court for the Southern
District of New York reached a verdict finding that a claim of Infosint’s
manufacturing process patent is valid and infringed by Forest’s importation and
sale in the United States of certain “citalopram products,” and to the extent
infringement was found, that the Company’s licensing partner H. Lundbeck A/S
induced any such infringement. As part of this verdict, the jury
awarded Infosint $15,000 in damages. Judge Lewis A. Kaplan entered
judgment on October 21, 2009 in accordance with the jury’s
verdict. Equitable defenses that may eliminate any damages award have
yet to be heard by the district court. Further, the Company plans to
file post-trial motions in the district court and appeal the case to the U.S.
Court of Appeals for the Federal Circuit, if necessary. The Company
also continues to believe that its license agreements with Lundbeck require
Lundbeck to indemnify the cost of defending this action and from any associated
damages or awards. During the quarter ended December 31, 2009,
Infosint commenced comparable litigation against a subsidiary of the Company in
the Republic of Ireland.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
AND
RESULTS OF OPERATIONS
(Dollar
amounts in thousands)
General
Total net
revenues increased for the quarter and nine months ended December 31, 2009 due
to strong sales of Lexapro®, Namenda®, Bystolic® and our newest product
Savella®. Savella is a selective serotonin and norepinephrine dual
reuptake inhibitor for the management of fibromyalgia which was launched in
April 2009. Net income increased 11.8% for the quarter as compared to
the same period last year. The December 2008 quarter included the
impact of $150,000 in combined new product license fees to Phenomix Corporation
(or Phenomix) for dutogliptin and Pierre Fabre Medicament (or Pierre Fabre) for
F2695. The current quarter included a $75,000 new product license fee
to Almirall, S.A. (or Almirall) for LAS100977, as well as $14,000 of
restructuring costs related to the closing of our packaging operations on Long
Island. Net income decreased 2.3% for the nine months ended December
31, 2009 as compared to the same period last year. The current nine
month period includes an upfront license fee of $100,000 to Nycomed GmbH (or
Nycomed) for Daxas®, and a $20,000 charge in connection with a settlement
agreement with Caraco Pharmaceutical Laboratories (or Caraco). These
charges were offset by the receipt of an upfront licensing payment of $40,000
from Astra Zeneca UK Limited (or AstraZeneca) for ceftaroline. During
last year’s nine month period we recorded a one-time charge of $44,100 to
selling, general and administrative expense as a result of terminating our
co-promotion agreement with Daiichi Sankyo (or Sankyo) for Azor®.
In
December 2009, we entered into a license agreement with Almirall to develop,
market and distribute LAS100977 in the United States. LAS100977 is
Almirall’s inhaled once-daily administered long-acting beta2 agonist that will
be developed in combination with an undisclosed corticosteroid for the treatment
of asthma and chronic obstructive pulmonary disease (COPD). Under the
terms of the agreement we made a $75,000 upfront payment to Almirall which was
recorded to research and development expense and we will pay future milestone
and sales based royalty payments. We will assume responsibility for
the United States regulatory approval and commercialization.
We also
entered into an agreement with AstraZeneca in December 2009 to acquire
additional rights to NXL104. The agreement includes amendments to our prior
agreement with Novexel, S.A. (or Novexel) covering the combination of NXL104
with ceftaroline and adds additional rights to the combination of NXL104 with
other compounds, including the antibiotic ceftazidime. NXL104 is
Novexel’s novel intravenous beta-lactamase inhibitor designed to be
co-administered with select antibiotics to enhance their spectrum of activity
and counteract bacterial resistance. Under the terms of the agreement
and following the completion of AstraZeneca’s acquisition of Novexel, we will
pay Novexel $210,000 plus certain additional costs for the additional rights to
NXL104 which will be recorded to research and development expense. In
addition, the transaction eliminates all future milestone payments and royalty
payments which we would have owed Novexel under the original license. The
transaction is expected to close during the fourth quarter of fiscal
2010. We may also be obligated to pay half of certain future
development milestones in connection with the transaction.
During
the current quarter we commenced closing our packaging operations based in our
Long Island, New York facility. As a result, we incurred a one-time
restructuring charge of $14,000 which was recorded to cost of
sales.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS (Continued)
(Dollar
amounts in thousands)
Financial Condition and
Liquidity
Net
current assets increased by $671,524 from March 31, 2009. Cash and
cash equivalents and marketable securities increased from ongoing
operations. Of our total cash and cash equivalents and marketable
securities position at December 31, 2009, 27%, or about $1,046,000, was
domiciled domestically with the remainder held by our international
subsidiaries. We currently invest funds in variable rate demand notes
that have major bank liquidity agreements, municipal bonds and notes, commercial
paper including money market instruments, auction rate securities and bank
floating rate notes. These investments are subject to general credit,
liquidity and market risks and have been affected by the global credit
crisis. Accumulated unrealized losses decreased by $48,296 to $21,957
on investments of $2,019,047 as compared with $70,253 in unrealized losses on
investments of $1,691,810 at March 31, 2009. We have recorded
unrealized losses on certain of these investments to other comprehensive
income. We believe these unrealized losses to be temporary in nature.
We do not have the intent to sell our investments and it is more likely than not
that we will not have to sell the investments before the recovery of our cost
basis. Trade accounts receivable increased due to higher sales of our
principal branded products. Raw materials and finished goods
inventory increased in order to support continued demand for our
products. We believe that current inventory levels are adequate to
support the growth of our ongoing business. Other current assets
decreased primarily due to a reduction in our current tax asset account that
resulted from accruing the current period tax expense against tax overpayments
made in prior periods. Current liabilities increased due to normal
operating activities.
Property,
plant and equipment before accumulated depreciation increased from March 31,
2009 as we continued to make technology investments to expand our principal
operating systems to enhance supply chain and salesforce
applications.
Management
believes that current cash levels, coupled with funds to be generated by ongoing
operations, will continue to provide adequate liquidity to facilitate potential
acquisitions of products, payment of achieved milestones and capital
investments.
Results of
Operations
Net sales
for the three and nine-month periods ended December 31, 2009 increased 8.4% and
6.2%, respectively, from the same periods last year to $997,002 and $2,907,958,
primarily due to strong sales of Lexapro, Namenda, Bystolic and our newest
product Savella.
Lexapro,
which is indicated for the treatment of depression in adults and adolescents and
generalized anxiety disorder in adults, and is our most significant product, had
sales of $582,591 and $1,714,061 for the quarter and nine months respectively, a
decrease of approximately 0.5% and 2.2% from the same periods last year, due to
a modest decline in market share. Lexapro sales decreased $2,882 and
$38,405 for the three and nine months as compared with the same periods last
year, of which $31,393 and $116,527 was due to volume decreases offset by
$28,511 and $78,122 related to price increases. During fiscal 2007,
Caraco filed an Abbreviated New Drug Application (or ANDA) with a Paragraph IV
Certification for a generic equivalent to Lexapro. We along with our
licensing partner H. Lundbeck A/S filed a lawsuit in the U.S. District Court for
the Eastern District of Michigan against Caraco for patent
infringement. In July 2009, we and Lundbeck entered into a settlement
agreement with Caraco and Sun Pharma. Lexapro’s patent is set to
expire in March 2012.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS (Continued)
(Dollar
amounts in thousands)
Sales of
Namenda, our N-methyl-D-aspartate (or NMDA) receptor antagonist for the
treatment of moderate and severe Alzheimer's disease grew 17.3% and 15.8% for the
current quarter and nine months, respectively, to $282,539 and $817,057. This
represents an increase of $41,688 and $111,527 as compared with the same periods last
year, of which $13,206 and $51,567 was due to volume and
$28,482 and $59,960 was due to
price. During the third quarter of fiscal 2008, we received
notification from several generic manufacturers that they filed ANDAs with
Paragraph IV Certifications to obtain approval to market generic equivalents of
Namenda. In January 2008, we along with our licensing partner Merz
Pharma GmbH & Co. KgaA commenced patent infringement litigation against
these generic manufacturers. See Note 12 to the Condensed
Consolidated Financial Statements for a discussion of certain settlements that
have been reached in this litigation. Namenda’s patent is set to
expire in April 2015.
Sales of
Bystolic (nebivolol hydrochloride), our beta-blocker indicated for the treatment
of hypertension, launched in January 2008, achieved sales of $47,452 and
$125,783 for the three and nine-month periods, respectively, as compared to
$20,961 and $39,498 for
the same periods last year. Sales of Savella, a selective
serotonin and norepinephrine dual reuptake inhibitor (or SNRI) for the
management of fibromyalgia launched in April 2009, achieved sales of $15,439 and
$35,278 for the current quarter and nine months ended December 31, 2009,
respectively. The remainder of the net sales change for the periods
presented was principally due to volume and price fluctuations of our older and
non-promoted product lines.
Contract
revenue for the three and nine months ended December 31, 2009 was $55,755 and
$154,053, respectively, compared to $52,433 and $153,796 in the same periods
last year primarily due to co-promotion income from our co-marketing agreement
with Sankyo for Benicar. Forest had been co-promoting Benicar,
indicated for the treatment of hypertension, since May 2002. Pursuant
to the agreement with Sankyo, active co-promotion of Benicar by Forest ended in
the first quarter of fiscal 2009 and we now receive a gradually reducing
residual royalty rate through March 2014. We are no longer incurring
any salesforce expenses for this product.
Other
income for the current nine months increased primarily due to a $40,000 upfront
license payment received from AstraZeneca during the September 2009
quarter. Interest income for the three and nine-month periods
decreased over the same periods last year primarily due to lower average rates
of return offset by higher levels of invested funds.
Cost of
sales as a percentage of net sales increased to 24.8% and 23.6% for the three
and nine-month periods of the current year as compared to 22.5% and 22.2% for
the same periods last year primarily due to the $14,000 one-time restructuring
charge related to our packaging operations in our Long Island
facility.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS (Continued)
(Dollar
amounts in thousands)
Selling,
general and administrative expense (SG&A) increased to $306,962 for the
current quarter as compared to $289,968 for the same period last year primarily
due to launch costs for Savella. SG&A decreased $15,491 for the
nine-month period ended December 31, 2009 as compared to the same period last
year. The current nine-month period includes a one-time charge of
$20,000 in connection with a settlement agreement with Caraco regarding patent
infringement disputes relating to Lexapro. The nine-month period
ended December 31, 2008 included a one-time charge of $44,100 relating to the
termination of the Azor co-promotion agreement and a $25,000 charge in
connection with a settlement of all claims against all defendants in a
securities litigation which had been pending against Forest and certain of our
officers. We have asserted a claim in connection with this charge
against our insurance carriers.
Research
and development expense decreased by $45,442 for the current quarter as compared
with the same period last year and increased $106,294 for the nine-month period
as compared with last year’s nine months due to the effects of the following
upfront license fee payments: $75,000 each to Phenomix for dutogliptin and
Pierre Fabre for F2695 in the December 2008 quarter; $75,000 to Almirall for LAS
100977 in the current quarter; and $100,000 to Nycomed for Daxas during the
September 2009 quarter. Excluding these upfront payments, research
and development expense increased 22.9% and 21.0% for the three and nine-month
periods, respectively.
Research
and development expense also reflects the following:
|
·
|
In
August 2009, we entered into a license agreement with Nycomed to develop
and commercialize Daxas (roflumilast) in the United
States. Daxas is a proprietary selective phosphodiesterase 4
(PDE4) enzyme inhibitor for oral administration developed by Nycomed for
the treatment of chronic obstructive pulmonary disease
(COPD). An NDA for Daxas was filed with the FDA in July 2009
and we expect an advisory committee review in April
2010.
|
|
·
|
In
October 2008, we entered into a collaboration agreement with Phenomix
Corporation to co-develop and co-promote
dutogliptin. Dutogliptin is Phenomix’ proprietary orally
administered small molecule DPP-4 inhibitor currently in Phase III
clinical development for Type II diabetes. We expect to have top-line
results for the first Phase III trial during the first half of calendar
2010 and in July 2009 we initiated additional Phase III trials for
dutogliptin.
|
|
·
|
In
December 2008, we entered into an agreement with Pierre Fabre to develop
and commercialize F2695 in the United States and Canada. F2695
is a proprietary selective norepinephrine and serotonin reuptake inhibitor
that is being developed for the treatment of depression. We
recently initiated Phase III studies for
F2695.
|
|
·
|
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 methicillin resistant Staphylococcus aureus and gram-negative
bacteria. In June 2008, we reported positive results from two
Phase III studies of ceftaroline for complicated skin and skin structure
infections and in June 2009, we reported positive results from two Phase
III studies for community acquired bacterial pneumonia. A New
Drug Application was filed with the FDA in December
2009.
|
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS (Continued)
(Dollar
amounts in thousands)
|
·
|
In
April 2006, we entered into an agreement with Almirall, S.A. 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. We recently reported top-line
results from our Phase III ACCORD COPD I study. The study
showed that aclidinium, administered by inhalation twice-daily, produced
statistically significant differences versus placebo in the primary
endpoint of trough FEV1 and was well tolerated. We and Almirall
have recently initiated additional Phase III studies with this dosing
regimen. We currently anticipate filing an NDA for aclidinium
in 2011. The development of a fixed-dose combination of aclidinium and the
beta-agonist formoterol is currently in Phase II
testing.
|
|
·
|
During
the September 2007 quarter, we entered into a partnership with Ironwood
Pharmaceuticals, Inc. to co-develop and co-market the compound linaclotide
in North America. Linaclotide is currently being investigated for the
treatment of constipation-predominant irritable bowel syndrome (IBS-C) and
chronic constipation (CC). Based on positive results of Phase
II(b) randomized, double-blind, placebo-controlled studies assessing the
safety and efficacy of linaclotide in patients with CC and IBS-C, we
initiated a comprehensive Phase III clinical program to evaluate
linaclotide’s safety and efficacy in patients with either IBS-C or
CC. We recently reported positive top-line data for the two
Phase III trials in CC. The IBS-C trials commenced in July 2009
and we expect to report top-line data in the second half of calendar
2010.
|
|
·
|
During
the third quarter of fiscal 2005, we entered into an 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 October 2009, we and Richter received positive
top-line results from a Phase II(b) dose-ranging study in schizophrenia
patients. Based on the data from this study and the positive
results from a previously reported Phase II trial in bipolar mania
disorder, we are initiating Phase III trials for both
indications. In addition, we have commenced Phase II proof of
concept studies in patients with Bipolar Depression Disorder and as add-on
treatment for Major Depressive
Disorder.
|
|
·
|
During
the third quarter of fiscal 2006, we entered into an agreement with
Richter for the North American rights to radiprodil (RGH-896), a compound
that targets the NR2B receptor being developed for the treatment of
chronic pain and other CNS conditions. We have commenced a
Phase II dose-ranging study of radiprodil in patients with diabetic
peripheral neuropathic pain, with results expected in the second half of
calendar 2010.
|
Among
other research and development projects we continue to support are mGLuR1/5, a
series of novel compounds that target group 1 metabotropic glutamate receptors
and NXL104, a novel intravenous beta-lactamase inhibitor being developed in
combination with ceftaroline. Many of our agreements require us to
participate in joint activities and committees, the purpose of which is to make
decisions along with our partners in the development of products. In
addition, we have entered into several arrangements to conduct pre-clinical drug
discovery.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS (Continued)
(Dollar
amounts in thousands)
Our
effective tax rate was 24.0% and 23.6% for the three and nine-month periods
ended December 31, 2009, as compared to 15.4% and 20.7% for the same periods
last year. The increase was primarily due to the effect of the upfront
license payment to Almirall and other tax matters compared to the impact of the
termination of the co-promotion agreement for Azor and other tax matters in the
same periods last year. Effective tax rates may be affected by
ongoing tax audits. See Note 11 to the Condensed Consolidated
Financial Statements.
We expect
to continue our profitability in the current fiscal year with continued growth
in our principal promoted products.
Inflation
has not had a material effect on our operations for the periods
presented.
Critical Accounting
Policies
The
following accounting policies are important in understanding our financial
condition and results of operations and should be considered an integral part of
the financial review. Refer to the notes to the condensed
consolidated financial statements for additional policies.
Estimates and
Assumptions
The
preparation of financial statements in conformity with generally accepted
accounting principles requires us to make estimates and assumptions that affect
the reported amounts of assets and liabilities and of revenues and expenses
during the reporting period. Estimates are made when accounting for
sales allowances, returns, rebates and other pricing adjustments, depreciation,
amortization and certain contingencies. Forest is subject to risks
and uncertainties, which may include but are not limited to competition, federal
or local legislation and regulations, litigation and overall changes in the
healthcare environment that may cause actual results to vary from
estimates. We review all significant estimates affecting the
financial statements on a recurring basis and record the effect of any
adjustments when necessary. Certain of these risks, uncertainties and
assumptions are discussed further under the section entitled “Forward Looking
Statements.”
Revenue
Recognition
Revenues
are recorded in the period the merchandise is shipped. As is typical
in the pharmaceutical industry, gross product sales are subject to a variety of
deductions, primarily representing rebates and discounts to government agencies,
wholesalers and managed care organizations. These deductions
represent estimates of the related liabilities and, as such, judgment is
required when estimating the impact of these sales deductions on gross sales for
a reporting period. Historically, our adjustments for actual future
settlements have not been material, and have resulted in either a net increase
or a net decrease to net income. If estimates are not representative
of actual settlement, results could be materially
affected. Provisions for estimated sales allowances, returns, rebates
and other pricing adjustments are accrued at the time revenues are recognized as
a direct reduction of such revenue.
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS (Continued)
(Dollar
amounts in thousands)
The
accruals are estimated based on available information, including third party
data, regarding the portion of sales on which rebates and discounts can be
earned, adjusted as appropriate for specific known events and the prevailing
contractual discount rate. Provisions are reflected either as a
direct reduction to accounts receivable or, to the extent that they are due to
entities other than customers, as accrued expenses. Adjustments to
estimates are recorded when customer credits are issued or payments are made to
third parties.
The
sensitivity of estimates can vary by program and type of
customer. However, estimates associated with Medicaid and contract
rebates are most at risk for adjustment because of the extensive time delay
between the recording of the accrual and its ultimate settlement, an interval
that can range up to one year. Because of this time lag, in any given
quarter, adjustments to actual may incorporate revisions of prior
quarters.
Provisions
for Medicaid and contract rebates during a period are recorded based upon the
actual historical experience ratio of rebates paid and actual prescriptions
written. The experience ratio is applied to the period’s sales to
determine the rebate accrual and related expense. This experience
ratio is evaluated regularly to ensure that the historical trends are as current
as practicable. As appropriate, we will adjust the ratio to more
closely match the current experience or expected future
experience. In assessing this ratio, we consider current contract
terms, such as the effect of changes in formulary status, discount rate and
utilization trends. Periodically, the accrual is adjusted based upon
actual payments made for rebates. If the ratio is not indicative of
future experience, results could be affected. Rebate accruals for
Medicaid were $32,640 at December 31, 2009 and $27,463 at December 31,
2008. Commercial discounts and other rebate accruals were $191,128 at
December 31, 2009 and $164,655 at December 31, 2008. These and other
rebate accruals are established in the period the related revenue was
recognized, resulting in a reduction to sales and the establishment of a
liability, which is included in accrued expenses.
The
following table summarizes the activity for the nine-month periods in the
accounts related to accrued rebates, sales returns and discounts (In thousands):
|
|
December 31, 2009
|
|
|
December 31, 2008
|
|
|
|
|
|
|
|
|
Beginning
balance
|
|
$ |
277,894 |
|
|
$ |
229,681 |
|
|
|
|
|
|
|
|
|
|
Provision
for rebates
|
|
|
418,337 |
|
|
|
375,892 |
|
Settlements
|
|
|
( 409,890 |
) |
|
|
( 356,734 |
) |
|
|
|
8,447 |
|
|
|
19,158 |
|
|
|
|
|
|
|
|
|
|
Provision
for returns
|
|
|
17,964 |
|
|
|
22,432 |
|
Settlements
|
|
|
( 16,825 |
) |
|
|
( 17,967 |
) |
|
|
|
1,139 |
|
|
|
4,465 |
|
|
|
|
|
|
|
|
|
|
Provision
for chargebacks and discounts
|
|
|
263,012 |
|
|
|
225,189 |
|
Settlements
|
|
|
( 259,322 |
) |
|
|
( 226,225 |
) |
|
|
|
3,690 |
|
|
|
( 1,036 |
) |
|
|
|
|
|
|
|
|
|
Ending
balance
|
|
$ |
291,170 |
|
|
$ |
252,268 |
|
FOREST
LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS (Continued)
(Dollar
amounts in thousands)
Deductions
for chargebacks (primarily discounts to group purchasing organizations and
federal government agencies) closely approximate actual as these deductions are
settled generally within 2-3 weeks of incurring the liability.
Forest's
policy relating to the supply of inventory at wholesalers is to maintain
stocking levels of up to three weeks and to keep monthly levels consistent from
year to year, based on patterns of utilization. We have historically
closely monitored wholesale customer stocking levels by purchasing information
directly from customers and by obtaining other third party
information. Unusual or unexpected variations in buying patterns or
utilizations are investigated.
Sales
incentives are generally given in connection with a new product
launch. These sales incentives are recorded as a reduction of
revenues and are based on terms fixed at the time goods are
shipped. New product launches may result in expected temporary
increases in wholesaler inventories, which as described above, are closely
monitored and historically have not resulted in increased product
returns.
Forward Looking
Statements
Except
for the historical information contained herein, the Management Discussion and
other portions of this Form 10-Q contain forward looking statements that involve
a number of risks and uncertainties, including the difficulty of predicting FDA
approvals, acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, changes in laws and regulations affecting the healthcare industry, and
the risk factors listed from time to time in our filings with the SEC, including
the Annual Report on Form 10-K for the fiscal year ended March 31,
2009.
Quantitative and Qualitative
Disclosures About Market Risk
In the
normal course of business, operations may be exposed to fluctuations in currency
values and interest rates. These fluctuations can vary the costs of
financing, investing and operating transactions. Because we had no
debt and only minimal foreign currency transactions, there was no material
impact on earnings due to fluctuations in interest and currency exchange
rates.
As of the
end of the period covered by this report, the Company conducted an evaluation,
under the supervision and with the participation of the principal executive
officer and principal financial officer, of the Company's disclosure controls
and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934 (the Exchange Act)). Based on this evaluation,
the principal executive officer and principal financial officer concluded that
the Company's disclosure controls and procedures are effective to ensure that
information required to be disclosed by the Company in reports that it files or
submits under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in Securities and Exchange Commission rules
and forms. There was no change in the Company's internal control over
financial reporting during the Company's most recently completed fiscal quarter
that has materially affected, or is reasonably likely to materially affect, the
Company's internal control over financial reporting.
Part II - Other
Information
Item 1. Legal
Proceedings
Forest is
party to certain legal proceedings described in our Annual Report on Form 10-K
for the fiscal year ended March 31, 2009 (or the 2009 10-K) and our Quarterly
Reports on Form 10-Q for the quarters ended June 30, 2009 and September 30,
2009.
There
have been no material changes with respect to the risk factors disclosed in our
Annual Report on Form 10-K for the fiscal year ended March 31, 2009 and our
Quarterly Reports on Form 10-Q for the quarters ended June 30, 2009 and
September 30, 2009.
Item 2. Unregistered Sales of Equity
Securities, Use of Proceeds and Issuer Repurchases of Equity
Securities
In May
2006 our Board of Directors (or the Board) authorized a share repurchase program
(or the 2007 Repurchase Program) for up to 25 million shares of our common
stock. On August 13, 2007 the Board authorized an additional 10
million shares to be available for repurchase. No shares were
repurchased during the quarter ended December 31, 2009. As of
February 8, 2010, 5.7 million shares were available for repurchase under the
2007 Repurchase Program.
Item
6.
|
Exhibits
|
|
|
|
|
|
|
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
|
|
101.INS
|
XBRL
Instance Document**
|
|
101.SCH
|
XBRL
Taxonomy Extension Schema Document**
|
|
101.PRE
|
XBRL
Taxonomy Presentation Linkbase Document**
|
|
101.CAL
|
XBRL
Taxonomy Calculation Linkbase Document**
|
|
101.LAB
|
XBRL
Taxonomy Label Linkbase Document**
|
|
|
**Attached
as Exhibit 101 to this Quarterly Report on Form 10-Q for the quarter ended
December 31, 2009 are the following materials, formatted in eXtensible
Business Reporting Language ("XBRL"): (i)
Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated
Statements of Income, (iii) Condensed Consolidated Statements of
Comprehensive Income, (iv) Condensed Consolidated Statements of Cash Flows
and (v) Notes to Condensed Consolidated Financial
Statements.
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
Date: February
9, 2010
Forest Laboratories,
Inc.
(Registrant)
/s/ Howard
Solomon
Howard
Solomon
Chief
Executive Officer
/s/ Francis I. Perier,
Jr.
Francis
I. Perier, Jr.
Senior
Vice President - Finance and
Chief
Financial Officer