Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
2. |
|
Recently Adopted Accounting Standards |
In December 2004, Financial Accounting Standards Board Position 109-2 (FASB Staff Position
109-2) was issued and was effective upon issuance. FASB Staff Position 109-2 establishes standards
for how an issuer accounts for a special one-time dividends received deduction on the repatriation
of certain foreign earnings to a U.S. taxpayer pursuant to the American Jobs Creation Act of 2004
(the Act). The Financial Accounting Standards Board (FASB) staff believes that the lack of
clarification of certain provisions within the Act and the timing of the enactment necessitate a
practical exception to the Statement of Financial Accounting Standards No. 109, Accounting for
Income Taxes (SFAS No. 109), requirement to reflect in the period of enactment the effect of a new
tax law. Accordingly, an enterprise is allowed time beyond the financial reporting period of
enactment to evaluate the effect of the Act on its plan for reinvestment or repatriation of foreign
earnings for purposes of applying SFAS No. 109. The Company determined during its second fiscal
quarter 2005 that it had sufficient information to make an informed decision on the impact of the
Act on the Companys repatriation plans and recorded a $32.8 million tax liability based on a plan
to repatriate approximately $674.0 million in extraordinary dividends as defined by the Act.
In October 2004, the FASB ratified the consensus reached by the Emerging Issues Task Force (EITF)
in EITF Issue No. 04-8, The Effect of Contingently Convertible Instruments on Diluted Earnings per
Share (EITF 04-8), which became effective for reporting periods ending after December 15, 2004.
EITF No. 04-8 requires all instruments that have embedded conversion features, including
contingently convertible debt, that are contingent on market conditions indexed to an issuers
share price to be included in diluted earnings per share computations, if dilutive, regardless of
whether the market conditions have been met. The Company adopted the provisions of EITF No. 04-8 in
its fourth fiscal quarter of 2004. All prior period diluted earnings per share amounts have been
restated to conform to the guidance in EITF No. 04-8.
In December 2004, Financial Accounting Standards Board Position 109-1 (FASB Staff Position 109-1)
was issued and was effective upon issuance. FASB Staff Position 109-1 requires the Company to treat
the effect of a newly enacted U.S. tax deduction, beginning in 2005, for income attributable to
U.S. production activities as a special deduction, and not a tax rate reduction, in accordance with
SFAS No. 109. The Company adopted the provisions of FASB Staff Position 109-1 in its first fiscal
quarter of 2005. The adoption did not have a material effect on the Companys unaudited condensed
consolidated financial statements.
New Accounting Standards Not Yet Adopted
In December 2004, Statement of Financial Accounting Standards No. 123 (revised 2004),
Share-Based
Payment (SFAS No. 123R), was issued. SFAS No. 123R is effective for entities that do not file as
small business issuers as of the beginning of the first fiscal year that begins after June 15,
2005, which is the Companys first fiscal quarter of 2006. SFAS No. 123R requires companies to
recognize in the income statement the grant-date fair value of stock options and other equity-based
compensation issued to employees. SFAS No. 123R sets accounting requirements for measuring,
recognizing and reporting share-based compensation, including income tax considerations. In
general, SFAS No. 123R does not express a preference for a type of valuation model for measuring
the grant date fair value, generally requires equity-classified and liability-classified awards to
be recognized in earnings over the requisite service period, generally the vesting period for
service condition awards, allows for a one-time policy election regarding one of two alternatives
for recognizing compensation cost for grant awards with graded vesting, and requires the use of the
estimated forfeitures method. Upon adoption of SFAS No. 123R, the Company will begin recognizing
the cost of stock options using the modified prospective application method whereby the cost of new
awards and awards modified, repurchased or cancelled after the required effective date and the
portion of awards for which the requisite service has not been rendered (unvested awards) that are
outstanding as of the required effective date shall be recognized as the requisite service is
rendered on or after the required effective date. Because the Company historically accounted for
share-based payment arrangements under the intrinsic value method of accounting, the Company will
continue to provide the disclosures required by Statement of Financial Accounting
7
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Standards No. 123 until the effective date of SFAS No. 123R, regarding pro forma net earnings and
basic and diluted earnings per share, had compensation expense for the Companys stock options been
recognized based upon the fair value for awards granted.
3. |
|
Acceleration of Vesting of Premium Priced Stock Options |
On July 30, 2001, the Company granted non-qualified stock options to purchase up to 2,500,000
shares of its common stock to participants, including the Companys executive officers, under the
Allergan, Inc. 2001 Premium Priced Stock Option Plan. Each option was issued with three tranches:
|
|
|
The first tranche has an exercise price equal to $88.55; |
|
|
|
The second tranche has an exercise price equal to $106.26; and |
|
|
|
The third tranche has an exercise price equal to $127.51. |
The 2001 Premium Priced Stock Option Plan provided that each tranche of an option would vest and
become exercisable upon the earlier of (i) the date on which the fair value of a share of the
Companys common stock equals or exceeds the applicable exercise price or (ii) five years from the
grant date (July 30, 2006). The options expire six years from the grant date (July 30, 2007). The
first tranche of the options vested and became exercisable on March 1, 2004 as a result of the fair
value of the Companys common stock exceeding $88.55.
In response to FAS No. 123R, on April 25, 2005, the Organization and Compensation Committee of the
Companys Board of Directors approved an acceleration of the vesting of the options issued under
the Allergan, Inc. 2001 Premium Priced Stock Option Plan that are held by the Companys current
employees, including the Companys executive officers, and certain former employees of the Company
who received grants while employees prior to the June 2002 spin-off of Advanced Medical Optics,
Inc. (AMO). The former employees of the Company are current employees of AMO. As a result of the
acceleration, the second tranche and third tranche of each option became immediately vested and
exercisable effective as of May 10, 2005. Unlike typical stock options that vest over a
predetermined period, the options, pursuant to their original terms, automatically vest as soon as they are in the money.
Consequently, as soon as the options have any value to the
participant, they would vest according to
their original terms. Therefore, early vesting does not provide any immediate benefit to participants,
including the Companys executive officers.
The acceleration of the options eliminated future compensation expense that the Company would
otherwise recognize in its income statement with respect to the vesting of such options following
the effectiveness of FAS No. 123R. The future expense that was eliminated is approximately $1.0
million, net of tax (of which approximately $0.1 million, net of tax, is attributable to options
held by executive officers). This amount, plus an additional $0.8 million, net of tax, representing
the total pro forma amount for the combined third and fourth fiscal quarters of 2005 that otherwise
would have been included in that quarters pro forma earnings disclosures, was reflected in the
Companys pro forma footnote disclosure for the three months ended June 24, 2005. This treatment is
permitted under the transition guidance provided by FAS No. 123R.
4. |
|
Restructuring Charges and Transition/Duplicate Operating Expenses |
Restructuring and Streamlining of European Operations
Effective January 2005, the Companys Board of Directors approved the initiation and implementation
of a restructuring of certain activities related to the Companys European operations. The
restructuring seeks to optimize operations, improve resource allocation and create a scalable,
lower cost and more efficient operating model for the Companys European research and development
(R&D) and commercial activities. Specifically, the restructuring anticipates moving key European
R&D and select commercial functions from the Companys Mougins, France and
8
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
other European locations to the Companys Irvine, California, High Wycombe, U.K. and Dublin,
Ireland facilities and streamlining functions in the Companys European management services group.
Under applicable law, the proposed restructuring requires consultations and, in certain cases,
negotiations with European and national works councils, other management/labor organizations and
local authorities, which the Company substantially completed by the end of its second fiscal
quarter 2005.
The Company has incurred and anticipates that it will continue to incur restructuring charges and
charges relating to severance, relocation and one-time termination benefits, payments to public
employment and training programs, implementation, transition, capital and other asset-related
expenses, duplicate operating expenses and contract termination costs in connection with the
restructuring. The Company currently estimates that the pre-tax charges resulting from the
restructuring, including transition and duplicate operating expenses, will be between $40 million
and $53 million and capital expenditures will be between $5 million and $7 million. The Company
began to incur these amounts beginning in the first quarter of 2005 and expects to continue to
incur them up through and including the second quarter of 2006. Of the total amount of pre-tax
charges and capital expenditures, approximately $45 million to $58 million are expected to be cash
expenditures.
The foregoing estimates are based on assumptions relating to, among other things, a reduction of
approximately 160 positions, principally R&D and selling, general and administrative positions in
the affected European locations. These workforce reduction activities began in the first quarter of
2005 and are expected to be substantially completed by the close of the second quarter of 2006.
Charges associated with the workforce reduction, including severance, relocation and one-time
termination benefits, and payments to public employment and training programs, are currently
expected to total approximately $28 million to $33 million. The Company began to incur these
charges in the first quarter of 2005 and expects to continue to incur them up through and including
the second quarter of 2006. Certain severance costs included in the estimates totaling
approximately $2 million to $3 million for a limited number of personnel are dependent upon the
employees future decision to continue employment after specific contractual work assignments end
between 2006 and 2007. These contingent contractual severance costs will be recorded in the period
when the Company determines that they become probable.
Estimated costs also include approximately $2 million to $7 million for contract and lease
termination costs and asset write-offs (primarily for accelerated amortization related to leasehold
improvements in facilities to be exited). These costs are currently expected to be recorded
beginning in the fourth quarter of 2005 and to be completed by the close of the second quarter of
2006.
Estimated implementation and transition related expenses include, among other things, legal,
consulting, recruiting, information system implementation costs and taxes. These costs are
currently expected to total approximately $9 million to $11 million. The Company began to record
these costs in the first quarter of 2005 and they are expected to continue up through and including
the second quarter of 2006. The Company also expects to incur duplicate operating expenses during
the transition period to ensure that job knowledge and skills are properly transferred to new
employees. These duplicate operating expenses are currently expected to total between $1 million
and $2 million. The Company began to record these costs in the first quarter of 2005 and they are
expected to continue up through and including the first quarter of 2006.
The Company also expects to incur additional capital expenditures for leasehold improvements
(primarily at a new facility in the United Kingdom to accommodate increased headcount). These
capital expenditures are currently estimated to be between approximately $5 million and $7 million.
The Company began to record these costs in the third quarter of 2005 and they are expected to
continue up through and including the second quarter of 2006.
During the first nine months of 2005, the Company recorded pre-tax restructuring charges of $24.5
million related to the restructuring of the Companys European operations. The restructuring
charges primarily consist of employee
9
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
severance, employee relocation and other costs. The following table presents the cumulative
restructuring activities through September 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in millions) |
|
Employee |
|
Other |
|
|
|
|
Severance |
|
Costs |
|
Total |
Net charge during 2005 |
|
$ |
22.8 |
|
|
$ |
1.7 |
|
|
$ |
24.5 |
|
Spending |
|
|
(7.1 |
) |
|
|
(1.7 |
) |
|
|
(8.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2005 (included in accrued expenses) |
|
$ |
15.7 |
|
|
$ |
|
|
|
$ |
15.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee severance in the preceding table relates to 159 employees, of which 44 were severed as of
September 30, 2005. Employee severance charges were based on social plans in France and Italy, and
the Companys severance practices for employees in the other affected European countries. During
the first nine months of 2005, the Company also recorded $3.1 million of transition/duplicate
operating expenses associated with the European restructuring activities. Transition/duplicate
operating expenses consisted primarily of salaries, travel, communications, recruitment and
consulting costs. Transition/duplicate operating expenses of $0.1 million in cost of sales, $2.0
million in selling, general and administrative expenses and $1.0 million in research and
development expenses have been included in the unaudited condensed consolidated statements of
earnings for the nine months ended September 30, 2005.
Termination of Manufacturing and Supply Agreement with Advanced Medical Optics
In October 2004, the Companys Board of Directors approved certain restructuring activities related
to the scheduled termination in June 2005 of the Companys manufacturing and supply agreement with
AMO. Under the manufacturing and supply agreement, which was entered into in connection with the
AMO spin-off, the Company agreed to manufacture certain contact lens care products and VITRAX, a
surgical viscoelastic, for AMO for a period of up to three years ending in June 2005. As part of
the termination of the manufacturing and supply agreement, the Company eliminated certain
manufacturing positions at the Companys Westport, Ireland; Waco, Texas; and Guarulhos, Brazil
manufacturing facilities.
The Company currently anticipates that the pre-tax restructuring charges to be incurred in
connection with the termination of the manufacturing and supply agreement will total between
approximately $22 million and $26 million. The Company began recording these charges in the fourth
quarter of 2004 and expects to continue recording them up through and including the third quarter
of 2006. Restructuring charges during 2006 primarily relate to the refurbishment of facilities
previously used for contract manufacturing. The pre-tax charges are net of expected tax credits
available under qualifying government-sponsored employment programs. Approximately $21 million of
the restructuring charges are expected to be cash charges. The restructuring charges are expected
to include approximately $18 million to $20 million associated with the reduction in the Companys
workforce of approximately 350 individuals. The workforce reduction, which began in the fourth
quarter of 2004 and was substantially completed in the second quarter of 2005, impacted personnel
in Europe, the United States and Latin America. The restructuring costs are also expected to
include approximately $4 million to $6 million of other costs associated with the termination of
the manufacturing and supply agreement.
As of September 30, 2005, the Company recorded cumulative pre-tax restructuring charges of $22.0
million related to the termination of the manufacturing and supply agreement. These charges
primarily include accruals for net statutory severance costs and the ratable recognition of
termination benefits to be earned by employees who are required to render service until they are
terminated in order to receive the termination benefits. Cumulative charges for employees
involuntarily and voluntarily terminated in the table below relate to 343 employees, of which 312
were severed as of September 30, 2005. Included in other costs within the table below is $0.3
million of inventory write-offs that have been recorded as a component of Cost of sales in the
unaudited condensed consolidated statements of earnings.
10
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The following table presents the cumulative restructuring activities through September 30, 2005
resulting from the scheduled termination of the Companys manufacturing and supply agreement with
AMO in June 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charges for Employees |
|
|
|
|
(in millions) |
|
Involuntarily and |
|
Other |
|
|
|
|
Voluntarily Terminated |
|
Costs |
|
Total |
Net charge during 2004 |
|
$ |
7.1 |
|
|
$ |
|
|
|
$ |
7.1 |
|
Spending |
|
|
(0.1 |
) |
|
|
|
|
|
|
(0.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004 |
|
|
7.0 |
|
|
|
|
|
|
|
7.0 |
|
Net charge during 2005 |
|
|
12.3 |
|
|
|
2.6 |
|
|
|
14.9 |
|
Assets written off |
|
|
|
|
|
|
(2.3 |
) |
|
|
(2.3 |
) |
Spending (net of employment tax credits received) |
|
|
(17.7 |
) |
|
|
(0.3 |
) |
|
|
(18.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2005 |
|
$ |
1.6 |
|
|
$ |
|
|
|
$ |
1.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The remaining balance at September 30, 2005 is comprised of accrued statutory severance and
one-time termination benefits of $2.3 million (included in accrued expenses), less expected
employment program tax credits receivable of $0.7 million (included in other current assets).
During the three months ended September 30, 2005, the Company reduced by $1.5 million the remaining
balance of other accrued costs associated with restructuring costs and asset write-offs previously
recorded in connection with the spin-off of AMO in 2002. This reduction in other accrued costs was
included in the Restructuring charge (reversal) for the three and nine months ended September 30,
2005. At September 30, 2005, the remaining balance for other accrued costs associated with the
2002 spin-off of AMO was $1.3 million.
5. |
|
Intangibles and Goodwill |
At September 30, 2005 and December 31, 2004, the components of amortizable and unamortizable
intangibles and goodwill and certain other related information were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangibles |
|
September 30, 2005 |
|
December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Amortization |
|
|
|
|
|
|
|
|
|
Amortization |
|
|
Gross |
|
Accumulated |
|
Period |
|
Gross |
|
Accumulated |
|
Period |
|
|
Amount |
|
Amortization |
|
(in years) |
|
Amount |
|
Amortization |
|
(in years) |
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
Amortizable Intangible |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing |
|
$ |
137.8 |
|
|
$ |
(21.1 |
) |
|
|
8.0 |
|
|
$ |
38.5 |
|
|
$ |
(10.6 |
) |
|
|
7.9 |
|
Trademarks |
|
|
3.6 |
|
|
|
(2.3 |
) |
|
|
15.0 |
|
|
|
3.5 |
|
|
|
(1.9 |
) |
|
|
15.0 |
|
Core Technology |
|
|
29.4 |
|
|
|
(3.6 |
) |
|
|
15.0 |
|
|
|
29.6 |
|
|
|
(2.2 |
) |
|
|
15.0 |
|
Other |
|
|
1.1 |
|
|
|
(0.9 |
) |
|
|
5.0 |
|
|
|
1.0 |
|
|
|
(0.7 |
) |
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
171.9 |
|
|
|
(27.9 |
) |
|
|
9.3 |
|
|
|
72.6 |
|
|
|
(15.4 |
) |
|
|
11.1 |
|
Unamortizable Intangible |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign business license |
|
|
0.9 |
|
|
|
|
|
|
|
|
|
|
|
0.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
172.8 |
|
|
$ |
(27.9 |
) |
|
|
|
|
|
$ |
73.5 |
|
|
$ |
(15.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing assets consist primarily of capitalized payments to third party licensors related to the
achievement of regulatory approvals to commercialize products in specified markets and up-front
payments associated with royalty obligations for products that have achieved regulatory approval
for marketing. The increase in licensing assets at September 30, 2005 compared to December 31, 2004
primarily relates to an up-front payment associated with a royalty buy-out agreement relating to
Restasis®, the Companys drug for the treatment of chronic dry eye disease.
11
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Core technology consists of a drug delivery technology acquired in connection with the acquisition
of Oculex Pharmaceuticals, Inc. in 2003.
Aggregate amortization expense for amortizable intangible assets was $5.2 million and $2.1 million
for the fiscal quarters ended September 30, 2005 and September 24, 2004, respectively, and $12.3
million and $6.2 million for the nine months ended September 30, 2005 and September 24, 2004,
respectively. Amortization expense related to licensing assets and core technology is primarily
included in cost of sales and research and development expenses, respectively.
Estimated amortization expense is $17.5 million for 2005, $20.3 million for 2006, $19.2 million for
2007, $17.4 million for 2008, $16.8 million for 2009 and $16.7 million for 2010.
Goodwill
|
|
|
|
|
|
|
|
|
(in millions) |
|
September 30, |
|
December 31, |
|
|
2005 |
|
2004 |
Goodwill: |
|
|
|
|
|
|
|
|
United States |
|
$ |
4.6 |
|
|
$ |
4.6 |
|
Latin America |
|
|
3.8 |
|
|
|
3.2 |
|
Europe and Other |
|
|
0.8 |
|
|
|
0.9 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
9.2 |
|
|
$ |
8.7 |
|
|
|
|
|
|
|
|
|
|
The changes in goodwill balances are the result of foreign currency translation.
Components of inventories were:
|
|
|
|
|
|
|
|
|
(in millions) |
|
September 30, |
|
December 31, |
|
|
2005 |
|
2004 |
Finished goods |
|
$ |
54.3 |
|
|
$ |
50.5 |
|
Work in process |
|
|
22.0 |
|
|
|
23.2 |
|
Raw materials |
|
|
14.2 |
|
|
|
16.2 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
90.5 |
|
|
$ |
89.9 |
|
|
|
|
|
|
|
|
|
|
Income taxes are determined using an estimated annual effective tax rate, which is generally
less than the U.S. Federal statutory rate, primarily because of lower tax rates in certain non-U.S.
jurisdictions and research and development (R&D) tax credits available in the United States. The
Company recognizes deferred tax assets and liabilities for temporary differences between the
financial reporting basis and the tax basis of the Companys assets and liabilities, along with net
operating loss and credit carryforwards. The Company records a valuation allowance against its
deferred tax assets to reduce the net carrying value to an amount that it believes is more likely
than not to be realized. When the Company establishes or reduces the valuation allowance against
its deferred tax assets, its income tax expense will increase or decrease, respectively, in the
period such determination is made.
Valuation allowances against the Companys deferred tax assets were $55.9 million and $51.9 million
at September 30, 2005 and December 31, 2004, respectively. Material differences may result in an
increase or decrease in the provision for income taxes if the actual amounts for valuation
allowances required against deferred tax assets differ from the amounts estimated by management.
12
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The Company has not provided for withholding and U.S. taxes for the unremitted earnings of certain
non-U.S. subsidiaries because the Company has reinvested or expects to reinvest these earnings
indefinitely in such operations. In connection with the American Jobs Creation Act of 2004 (the
Act), the Company determined during its second fiscal quarter of 2005 that it had sufficient
information to make an informed decision regarding the repatriation of certain foreign earnings
that were previously considered to be permanently reinvested. Based on that decision, the Company
recorded a $32.8 million tax liability associated with the Companys decision to repatriate $674.0
million in extraordinary dividends, as defined by the Act, from unremitted foreign earnings that
were previously considered permanently reinvested by certain non-U.S. subsidiaries. The $674.0
million amount of extraordinary dividends is the qualified amount above a $53.4 million base amount
determined based on the Companys historical repatriation levels, as defined by the Act. The tax
effect of the base amount of dividends is included in the Companys estimated annual effective tax
rate. The Company also decided to repatriate approximately $85.8 million in additional dividends
above the base and extraordinary dividend amounts from prior and current years unremitted foreign
earnings that were previously considered indefinitely reinvested and recorded a corresponding tax
liability of $27.6 million in the second quarter of 2005. During the three months ended September
30, 2005, the Company repatriated $759.8 million in extraordinary dividends and additional
dividends above the base and extraordinary dividend amounts and reduced the estimated income tax
liability related to the additional dividends above the base and extraordinary dividend amounts by
$6.2 million to $21.4 million. This reduction in the estimated income tax liability related to the
additional dividends represents a change in estimate based upon the actual repatriation that
occurred during the third quarter of 2005.
During the three months ended September 30, 2005, the Company reduced its reserves for uncertain
tax positions and related provision for income taxes by $19.5 million, primarily due to a change in
estimate resulting from the resolution of several significant uncertain income tax audit issues,
including transfer prices, the deductibility of transaction costs associated with the 2002 spin-off
of AMO and intangible asset issues related to certain assets of Bardeen Sciences Company, LLC,
which we acquired in 2003. This change in estimate relates to tax years currently under
examination or not yet settled through expiry of the statute of limitations.
8. |
|
Employee Retirement and Other Benefit Plans |
The Company sponsors various qualified defined benefit pension plans covering a substantial
portion of its employees. In addition, the Company sponsors two supplemental nonqualified plans
covering certain management employees and officers and one retiree health plan covering United
States retirees and dependents.
Components of net periodic benefit cost for the three and nine month periods ended September 30,
2005 and September 24, 2004, respectively, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Postretirement |
(in millions) |
|
Pension Benefits |
|
Benefits |
|
|
September 30, |
|
September 24, |
|
September 30, |
|
September 24, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Service cost |
|
$ |
4.3 |
|
|
$ |
3.8 |
|
|
$ |
0.3 |
|
|
$ |
0.2 |
|
Interest cost |
|
|
6.2 |
|
|
|
5.9 |
|
|
|
0.3 |
|
|
|
0.3 |
|
Expected return on plan assets |
|
|
(6.7 |
) |
|
|
(6.8 |
) |
|
|
|
|
|
|
|
|
Amortization of prior service cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.1 |
) |
Recognized net actuarial loss |
|
|
2.4 |
|
|
|
1.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
6.2 |
|
|
$ |
4.8 |
|
|
$ |
0.6 |
|
|
$ |
0.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Postretirement |
(in millions) |
|
Pension Benefits |
|
Benefits |
|
|
September 30, |
|
September 24, |
|
September 30, |
|
September 24, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Service cost |
|
$ |
13.4 |
|
|
$ |
8.5 |
|
|
$ |
1.1 |
|
|
$ |
1.0 |
|
Interest cost |
|
|
18.8 |
|
|
|
11.8 |
|
|
|
1.0 |
|
|
|
0.9 |
|
Expected return on plan assets |
|
|
(20.7 |
) |
|
|
(13.8 |
) |
|
|
|
|
|
|
|
|
Amortization of prior service cost |
|
|
|
|
|
|
0.1 |
|
|
|
(0.1 |
) |
|
|
(0.2 |
) |
Recognized net actuarial loss |
|
|
7.3 |
|
|
|
3.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit cost |
|
$ |
18.8 |
|
|
$ |
10.3 |
|
|
$ |
2.0 |
|
|
$ |
1.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In 2005, the Company currently expects to pay contributions in the range of $46.4 million and $48.4
million to its U.S. and non-U.S. pension plans and between $0.6 million and $0.7 million to its
other postretirement plan.
The Company is involved in various lawsuits and claims arising in the ordinary course of
business. The Company follows the provisions of Statement of Financial Accounting Standards No. 5
Accounting for Contingencies (SFAS No. 5). SFAS No. 5 requires that an estimated loss from a loss
contingency should be accrued for by a charge to income if it is both probable that an asset has
been impaired or that a liability has been incurred and the amount of the loss can be reasonably
estimated.
On June 6, 2001, after receiving paragraph 4 invalidity and noninfringement Hatch-Waxman Act
certifications from Apotex indicating that Apotex had filed an Abbreviated New Drug Application
with the FDA for a generic form of Acular®, the Company and Roche Palo Alto, LLC, formerly known as
Syntex (U.S.A.) LLC, the holder of the Acular® patent, filed a lawsuit entitled Syntex (U.S.A.)
LLC and Allergan, Inc. v. Apotex, Inc., et al. in the United States District Court for the
Northern District of California. Following a trial, the court entered final judgment in the
Companys favor on January 27, 2004, holding that the patent at issue is valid, enforceable and
infringed by Apotexs proposed generic drug. On February 17, 2004, Apotex filed a Notice of Appeal
with the United States Court of Appeals for the Federal Circuit. On May 18, 2005, the Court of
Appeals for the Federal Circuit issued an opinion affirming the lower courts ruling on inequitable
conduct and claim construction and reversing and remanding the issue of obviousness. The court
did not address the issue of infringement. On August 13, 2005, Apotex filed a motion to vacate
the injunction pending resolution of the remand from the United States Court of Appeals for the Federal
Circuit on the obviousness. On October 28, 2005, the court denied Apotexs motion. On June 29,
2001, the Company filed a separate lawsuit in Canada against Apotex similarly relating to a generic
version of Acular®. A mediation in the Canadian lawsuit was held on January 4, 2005 and a
settlement conference previously scheduled for April 6, 2005 was originally continued to summer
2005. A new date for the summer 2005 status conference has not been set.
On June 2, 2003, a complaint entitled Klein-Becker usa, LLC v. Allergan, Inc. was filed in the
United States District Court for the District of Utah Central Division. The complaint, as later
amended, contained claims against the Company for intentional interference with contractual and
economic relations and unfair competition under federal and Utah law. The complaint sought
declaratory and injunctive relief, based on allegations that the Company interfered with
Klein-Beckers contractual and economic relations by dissuading certain magazines from running
Klein-Beckers advertisements for its anti-wrinkle cream. On July 30, 2003, the Company filed a
reply and counterclaims against Klein-Becker, asserting, as later amended, claims for false
advertising, unfair competition under federal and Utah law, trade libel, trademark infringement and
dilution, and seeking declaratory relief in connection with Klein-Beckers advertisements for its
anti-wrinkle cream that use the heading Better than BOTOX®? On July 31, 2003, the court denied
Klein-Beckers application for a temporary restraining order to
14
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
restrain the Company from, among other things, contacting magazines regarding Klein-Beckers
advertisements. On October 7, 2003, the court granted in part and denied in part the Companys
motion to dismiss Klein-Beckers complaint, dismissing Klein-Beckers claims for unfair competition
under federal and Utah law and its motion for injunctive relief. On August 14, 2004, the court
denied in its entirety Klein-Beckers motion to dismiss the Companys claims. From July 2004
through December 2004, the case was voluntarily stayed while the parties explored settlement
through mediation. The voluntary stay ended December 29, 2004, without the parties reaching
settlement. On March 2, 2005, Klein-Becker filed a motion to amend the scheduling order and a
motion for leave to amend the first amended complaint. On August 4, 2005, Klein-Becker filed a
motion for partial summary judgment. On August 24, 2005, the court granted Klein-Beckers motion
to amend the scheduling order and Klein-Beckers motion for leave to amend the first amended
complaint. On September 16, 2005, Klein-Becker filed its second amended complaint asserting claims
for cancellation of registered trademark, false advertising and unfair competition, intentional
interference with potential and existing contractual relations, and declaratory relief. On October
7, 2005, the Company filed its response to the second amended complaint and a motion to dismiss
certain claims in Klein-Beckers second amended complaint. On October 25, 2005, the Company filed
a motion for partial summary judgment and a motion for preliminary injunction. The hearing on
Klein-Beckers motion for partial summary judgment is set for December 19, 2005. Trial has been
set for May 8, 2006.
On July 13, 2004, the Company received a paragraph 4 Hatch-Waxman Act certification from Alcon,
Inc. indicating that Alcon had filed a New Drug Application with the FDA for a drug containing
brimonidine tartrate ophthalmic solution in a 0.15% concentration. In the certification, Alcon
contends that U.S. Patent Nos. 5,424,078; 6,562,873; 6,627,210; 6,641,834; and 6,673,337, all of
which are assigned to the Company or its wholly-owned subsidiary, Allergan Sales, LLC, and are
listed in the Orange Book under Alphagan® P, are invalid and/or not infringed by the proposed Alcon
product. On August 24, 2004, the Company filed a complaint, entitled Allergan, Inc., Allergan
Sales, LLC v. Alcon, Inc., Alcon Laboratories, Inc., and Alcon Research, Ltd., against Alcon for
patent infringement in the United States District Court for the District of Delaware. On September
3, 2004, Alcon filed an answer to the complaint and a counterclaim against the Company. On
September 23, 2004, the Company filed a reply to Alcons counterclaim. On May 2, 2005, Alcon filed
a Motion for Summary Judgment of Non-Infringement of U.S. Patent No. 6,673,337 and Invalidity of
U.S. Patent No. 6,641,834. The court took the Motion for Summary Judgment under submission without
oral argument. On July 25, 2005, Alcon filed a motion for leave to amend its answer to the
complaint and counterclaim. On July 26, 2005, the court adopted the Companys proposed claim
construction. Trial is scheduled for March 6, 2006. Pursuant to the Hatch-Waxman Act, approval of
Alcons generic New Drug Application is stayed until the earlier of (1) 30 months from the date of
the paragraph 4 certification, or (2) a ruling in the patent infringement litigation in Alcons
favor.
On August 26, 2004, a complaint entitled Clayworth, et al. v. Allergan, Inc., et al. was filed in
the Superior Court of the State of California for the County of Alameda. The complaint, as amended,
names the Company and 12 other defendants and alleges unfair business practices based upon a price
fixing conspiracy in connection with the reimportation of
pharmaceuticals from Canada. The complaint seeks damages, equitable
relief, attorney's fees and costs. On November
22, 2004, the pharmaceutical defendants jointly filed a demurrer to the first amended complaint. On
February 4, 2005, the court issued an order sustaining the pharmaceutical defendants demurrer and
granting plaintiffs leave to further amend the first amended complaint. On February 22, 2005, the
plaintiffs filed a second amended complaint to which the pharmaceutical defendants filed a
demurrer. A hearing on the demurrer to the second amended complaint took place on April 8, 2005. On
April 19, 2005, the court sustained the pharmaceutical defendants demurrer and granted the
plaintiffs leave to further amend the second amended complaint. On May 6, 2005, the plaintiffs
filed a third amended complaint. On May 27, 2005, the pharmaceutical defendants filed a demurrer.
The hearing on the demurrer to the third amended complaint took place on June 30, 2005. On July 1,
2005, the court overruled in part and sustained without leave to amend in part the pharmaceutical
defendants demurrer, dismissing the portion of plaintiffs third amended complaint alleging that
the pharmaceutical defendants violated Californias Unfair Competition Law by charging plaintiffs
more for pharmaceuticals than they charged others outside of the United States for the same
pharmaceuticals. The court overruled the pharmaceutical defendants demurrer with respect to
plaintiffs claim under the Cartwright Law that
15
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
the pharmaceutical defendants conspired to maintain high, non-competitive prices for
pharmaceuticals in the United States and sought to restrict the importation of lower-priced
pharmaceuticals into the United States. The pharmaceutical defendants response to the third
amended complaint was filed on July 15, 2005. Trial has been set for July 10, 2006.
On May 24, 2005, after receiving paragraph 4 invalidity and noninfringement Hatch-Waxman Act
certifications from Apotex indicating that Apotex had filed an Abbreviated New Drug Application
with the FDA for a generic form of Acular LS®, the Company and Roche Palo Alto, LLC,
formerly known as Syntex (U.S.A.) LLC, the holder of the Acular LS® patent, filed a
lawsuit entitled Roche Palo Alto LLC, formerly known as Syntex (U.S.A.) LLC and Allergan, Inc. v.
Apotex, Inc., et al. in the United States District Court for the Northern District of California.
In the complaint, the Company and Roche asked the court to find that the Acular LS®
patent is valid, enforceable and infringed by Apotexs proposed generic drug. On July 25, 2005,
Apotex filed an answer to the complaint and a counterclaim against the Company and Roche. On August
26, 2005, the Company filed its response to Apotexs counterclaim. On August 30, 2005, the court
ordered this case related to the action entitled Syntex (U.S.A.) LLC and Allergan, Inc. v. Apotex,
Inc., et al. noted above.
The Company is involved in various other lawsuits and claims arising in the ordinary course of
business. These other matters are, in the opinion of management, immaterial both individually and
in the aggregate with respect to the Companys consolidated financial position, liquidity or
results of operations.
Because of the uncertainties related to the incurrence, amount and range of loss on any pending
litigation, investigation or claim, management is currently unable to predict the ultimate outcome
of any litigation, investigation or claim, determine whether a liability has been incurred or make
a reasonable estimate of the liability that could result from an unfavorable outcome. The Company
believes, however, that the liability, if any, resulting from the aggregate amount of uninsured
damages for any outstanding litigation, investigation or claim will not have a material adverse
effect on the Companys consolidated financial position, liquidity or results of operations.
However, an adverse ruling in a patent infringement lawsuit involving the Company could materially
affect the Companys ability to sell one or more of its products or could result in additional
competition. In view of the unpredictable nature of such matters, the Company cannot provide any
assurances regarding the outcome of any litigation, investigation or claim to which the Company is
a party or the impact on the Company of an adverse ruling in such matters. As additional
information becomes available, the Company will assess its potential liability and revise its
estimates.
The Companys Certificate of Incorporation, as amended, provides that the Company will
indemnify, to the fullest extent permitted by the Delaware General Corporation Law, each person
that is involved in or is, or is threatened to be, made a party to any action, suit or proceeding
by reason of the fact that he or she, or a person of whom he or she is the legal representative, is
or was a director or officer of the Company or was serving at the request of the Company as a
director, officer, employee or agent of another corporation or of a partnership, joint venture,
trust or other enterprise. The Company has also entered into contractual indemnity agreements with
each of its directors and executive officers, pursuant to which the Company has agreed to indemnify
such directors and executive officers against any payments they are required to make as a result of
a claim brought against such executive officer or director in such capacity, excluding claims (i)
relating to the action or inaction of a director or executive officer that resulted in such
director or executive officer gaining personal profit or advantage, (ii) for an accounting of
profits made from the purchase or sale of securities of the Company within the meaning of Section
16(b) of the Securities Exchange Act of 1934 or similar provisions of any state law or (iii) that
are based upon or arise out of such directors or executive officers knowingly fraudulent,
deliberately dishonest or willful misconduct. The maximum potential amount of future payments that
the Company could be required to make under these indemnification provisions is unlimited. However,
the Company has purchased directors and officers liability
16
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
insurance policies intended to reduce the Companys monetary exposure and to enable the
Company to recover a portion of any future amounts paid. The Company has not previously paid any
material amounts to defend lawsuits or settle claims as a result of these indemnification
provisions. As a result, the Company believes the estimated fair value of these indemnification
arrangements is minimal.
The Company customarily agrees in the ordinary course of its business to indemnification provisions
in agreements with clinical trials investigators in its drug development programs, in sponsored
research agreements with academic and not-for-profit institutions, in various comparable agreements
involving parties performing services for the Company in the ordinary course of business, and in
its real estate leases. The Company also customarily agrees to certain indemnification provisions
in its drug discovery and development collaboration agreements. With respect to the Companys
clinical trials and sponsored research agreements, these indemnification provisions typically apply
to any claim asserted against the investigator or the investigators institution relating to
personal injury or property damage, violations of law or certain breaches of the Companys
contractual obligations arising out of the research or clinical testing of the Companys compounds
or drug candidates. With respect to real estate lease agreements, the indemnification provisions
typically apply to claims asserted against the landlord relating to personal injury or property
damage caused by the Company, to violations of law by the Company or to certain breaches of the
Companys contractual obligations. The indemnification provisions appearing in the Companys
collaboration agreements are similar, but in addition provide some limited indemnification for the
collaborator in the event of third party claims alleging infringement of intellectual property
rights. In each of the above cases, the term of these indemnification provisions generally survives
the termination of the agreement. The maximum potential amount of future payments that the Company
could be required to make under these provisions is generally unlimited. The Company has purchased
insurance policies covering personal injury, property damage and general liability intended to
reduce the Companys exposure for indemnification and to enable the Company to recover a portion of
any future amounts paid. The Company has not previously paid any material amounts to defend
lawsuits or settle claims as a result of these indemnification provisions. As a result, the Company
believes the estimated fair value of these indemnification arrangements is minimal.
17
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The table below presents the computation of basic and diluted earnings per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 30, |
|
September 24, |
|
September 30, |
|
September 24, |
(in millions, except per share amounts) |
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Net earnings |
|
$ |
150.5 |
|
|
$ |
92.0 |
|
|
$ |
263.8 |
|
|
$ |
264.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares issued |
|
|
131.0 |
|
|
|
131.5 |
|
|
|
130.8 |
|
|
|
131.3 |
|
Net shares assumed issued using the
treasury stock method for options and
non-vested equity shares and share
units outstanding during each period
based on average market price |
|
|
2.1 |
|
|
|
0.7 |
|
|
|
1.5 |
|
|
|
1.7 |
|
Dilutive effect of assumed conversion
of convertible notes outstanding |
|
|
1.6 |
|
|
|
0.6 |
|
|
|
0.9 |
|
|
|
1.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
134.7 |
|
|
|
132.8 |
|
|
|
133.2 |
|
|
|
134.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
1.15 |
|
|
$ |
0.70 |
|
|
$ |
2.02 |
|
|
$ |
2.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
1.12 |
|
|
$ |
0.69 |
|
|
$ |
1.98 |
|
|
$ |
1.97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three and nine month periods ended September 30, 2005, options to purchase 1.3 million and
3.7 million shares of common stock at exercise prices ranging from $90.33 to $127.51 and $82.40 to
$127.51 per share, respectively, were outstanding, but were not included in the computation of
diluted earnings per share because the options exercise prices were greater than the average
market price of common shares during the respective periods and, therefore, the effect would be
anti-dilutive. For the three and nine month periods ended September 24, 2004, options to purchase
5.5 million and 2.2 million shares of common stock at exercise prices ranging from $76.51 to
$127.51 per share and $83.79 to $127.51 per share, respectively, were outstanding, but were not
included in the computation of diluted earnings per share because the options exercise prices were
greater than the average market price of common shares during the respective periods and,
therefore, the effect would be anti-dilutive.
The following table summarizes components of comprehensive income for the three and nine month
periods ended September 30, 2005, and September 24, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
(in millions) |
|
September 30, 2005 |
|
September 24, 2004 |
|
|
|
|
|
|
Tax |
|
|
|
|
|
|
|
|
|
Tax |
|
|
|
|
Before-tax |
|
(expense) |
|
Net-of-tax |
|
Before-tax |
|
(expense) |
|
Net-of-tax |
|
|
amount |
|
or benefit |
|
amount |
|
amount |
|
or benefit |
|
amount |
Foreign currency translation adjustments |
|
$ |
3.2 |
|
|
$ |
|
|
|
$ |
3.2 |
|
|
$ |
3.8 |
|
|
$ |
|
|
|
$ |
3.8 |
|
Unrealized holding gains/(losses) arising
during period |
|
|
0.5 |
|
|
|
(0.4 |
) |
|
|
0.1 |
|
|
|
0.2 |
|
|
|
|
|
|
|
0.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive earnings (loss) |
|
$ |
3.7 |
|
|
$ |
(0.4 |
) |
|
|
3.3 |
|
|
$ |
4.0 |
|
|
$ |
|
|
|
|
4.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
150.5 |
|
|
|
|
|
|
|
|
|
|
|
92.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
$ |
153.8 |
|
|
|
|
|
|
|
|
|
|
$ |
96.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
(in millions) |
|
September 30, 2005 |
|
September 24, 2004 |
|
|
|
|
|
|
Tax |
|
|
|
|
|
|
|
|
|
Tax |
|
|
|
|
Before-tax |
|
(expense) |
|
Net-of-tax |
|
Before-tax |
|
(expense) |
|
Net-of-tax |
|
|
amount |
|
or benefit |
|
amount |
|
amount |
|
or benefit |
|
amount |
Foreign currency translation adjustments |
|
$ |
(0.9 |
) |
|
$ |
|
|
|
$ |
(0.9 |
) |
|
$ |
(0.7 |
) |
|
$ |
|
|
|
$ |
(0.7 |
) |
Unrealized holding gains/(losses) arising
during period |
|
|
1.0 |
|
|
|
(0.7 |
) |
|
|
0.3 |
|
|
|
(0.1 |
) |
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive earnings (loss) |
|
$ |
0.1 |
|
|
$ |
(0.7 |
) |
|
|
(0.6 |
) |
|
$ |
(0.8 |
) |
|
$ |
0.1 |
|
|
|
(0.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
263.8 |
|
|
|
|
|
|
|
|
|
|
|
264.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
$ |
263.2 |
|
|
|
|
|
|
|
|
|
|
$ |
263.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13. |
|
Business Segment Information |
The
Company currently operates its business on the basis of a single reportable segment specialty
pharmaceuticals. The Company produces a broad range of ophthalmic products for glaucoma therapy,
ocular inflammation, infection, allergy and dry eye; skin care products for acne, psoriasis and
other prescription and over-the-counter dermatological products; and Botox® for certain therapeutic
and cosmetic indications. The Company provides global marketing strategy teams to ensure
development and execution of a consistent marketing strategy for its products in all geographic
regions that share similar distribution channels and customers.
Management evaluates its various global product portfolios on a revenue basis, which is presented
below. The Company operates globally with principal markets in the United States, Europe, Latin
America and Asia Pacific. The United States information is presented separately as it is the
Companys headquarters country. U.S. sales, including manufacturing operations, represented 69.0%
and 69.2% of the Companys total consolidated product net sales for the quarters ended September
30, 2005 and September 24, 2004, respectively, and 67.7% and 69.4% of the Companys total
consolidated product net sales for the nine month periods ended September 30, 2005 and September
24, 2004, respectively.
Sales to McKesson Drug Company for the three month periods ended September 30, 2005 and September
24, 2004 were 15.2% and 13.9%, respectively, of the Companys total consolidated product net sales
and 14.1% and 13.7% of the Companys total consolidated product net sales for the nine month
periods ended September 30, 2005 and September 24, 2004, respectively. Sales to Cardinal Healthcare
for the three month periods ended September 30, 2005 and September 24, 2004 were 15.8% and 13.9%,
respectively, of the Companys total consolidated product net sales and 14.9% and 13.6% of the
Companys total consolidated product net sales for the nine month periods ended September 30, 2005
and September 24, 2004, respectively. No other country or single customer generates over 10% of
total product net sales. Other product net sales and net sales for manufacturing operations
primarily represent sales to AMO pursuant to the manufacturing and supply agreement entered into as
part of the 2002 AMO spin-off that was terminated as scheduled in June 2005. Net sales for the
Europe region also include sales to customers in Africa and the Middle East, and net sales in the
Asia Pacific region also include sales to customers in Australia and New Zealand.
19
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Net Sales by Product Line
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in millions) |
|
Three months ended |
|
Nine months ended |
|
|
September 30, |
|
September 24, |
|
September 30, |
|
September 24, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Specialty Pharmaceuticals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye Care Pharmaceuticals |
|
$ |
358.1 |
|
|
$ |
285.4 |
|
|
$ |
981.1 |
|
|
$ |
835.1 |
|
Botox®/Neuromodulators |
|
|
214.8 |
|
|
|
174.6 |
|
|
|
603.6 |
|
|
|
502.2 |
|
Skin Care |
|
|
33.0 |
|
|
|
24.8 |
|
|
|
93.2 |
|
|
|
73.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
605.9 |
|
|
|
484.8 |
|
|
|
1,677.9 |
|
|
|
1,411.2 |
|
Other |
|
|
0.2 |
|
|
|
26.0 |
|
|
|
46.4 |
|
|
|
78.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
606.1 |
|
|
$ |
510.8 |
|
|
$ |
1,724.3 |
|
|
$ |
1,489.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Geographic Information
Net Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in millions) |
|
Three months ended |
|
Nine months ended |
|
|
September 30, |
|
September 24, |
|
September 30, |
|
September 24, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
United States |
|
$ |
417.9 |
|
|
$ |
328.8 |
|
|
$ |
1,124.0 |
|
|
$ |
960.6 |
|
Europe |
|
|
98.6 |
|
|
|
82.9 |
|
|
|
300.6 |
|
|
|
240.6 |
|
Latin America |
|
|
32.5 |
|
|
|
25.5 |
|
|
|
91.2 |
|
|
|
72.7 |
|
Asia Pacific |
|
|
35.1 |
|
|
|
31.7 |
|
|
|
102.9 |
|
|
|
90.9 |
|
Other |
|
|
21.9 |
|
|
|
17.4 |
|
|
|
62.9 |
|
|
|
51.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
606.0 |
|
|
|
486.3 |
|
|
|
1,681.6 |
|
|
|
1,415.9 |
|
Manufacturing operations |
|
|
0.1 |
|
|
|
24.5 |
|
|
|
42.7 |
|
|
|
73.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
606.1 |
|
|
$ |
510.8 |
|
|
$ |
1,724.3 |
|
|
$ |
1,489.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets are assigned to geographic regions based upon management responsibility for such items.
Long-Lived Assets
|
|
|
|
|
|
|
|
|
(in millions) |
|
September 30, |
|
December 31, |
|
|
2005 |
|
2004 |
United States |
|
$ |
169.2 |
|
|
$ |
76.6 |
|
Europe |
|
|
20.7 |
|
|
|
24.5 |
|
Latin America |
|
|
18.8 |
|
|
|
17.2 |
|
Asia Pacific |
|
|
2.6 |
|
|
|
3.3 |
|
Other |
|
|
0.4 |
|
|
|
0.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
211.7 |
|
|
|
122.1 |
|
Manufacturing operations |
|
|
248.2 |
|
|
|
207.9 |
|
General corporate |
|
|
188.2 |
|
|
|
227.9 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
648.1 |
|
|
$ |
557.9 |
|
|
|
|
|
|
|
|
|
|
14. |
|
Sales Tax Contingency |
In accordance with the Companys interpretation of current law, the Company generally does not
collect or pay sales or other tax on sales of Botox® or Botox® Cosmetic in the United States.
However, the Company believes that one or more states may seek to impose sales or other tax
collection or payment obligations on the Companys sales of Botox® or Botox® Cosmetic to physicians
and other customers. If it is determined that the Company should collect or pay sales or other
transaction tax in one or more states, the imposition and collection of sales or other transaction
tax on Botox® or Botox® Cosmetic could result in a substantial tax liability, and potential
penalties and
20
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
interest, for prior taxable periods. The imposition and collection of sales or other
transaction tax on Botox® or Botox® Cosmetic could also adversely affect the Companys sales or its
product margins on Botox® or Botox® Cosmetic due to the increased cost associated with those
products.
The Company is not currently aware of any asserted claims for sales or other transaction tax
liabilities for prior taxable periods. The Company intends to work with state taxing authorities in
the normal course of business to ensure the proper interpretation and administration of sales and
other tax regulations on sales of Botox® and Botox® Cosmetic. The Company has not recorded any
accrued costs for potential unasserted claims for unpaid sales or other transaction tax. The
Company does not currently believe that any individual claim or aggregate claims that might arise
will ultimately have a material effect on its consolidated results of operations, financial
position or cash flows.
15. |
|
Agreement with GlaxoSmithKline and Restructuring and Streamlining of Japan Operations |
On September 30, 2005, the Company entered into a long-term agreement with GlaxoSmithKline plc
(GSK) to develop and promote the Companys Botox® (botulinum toxin type A) in Japan and China and
to co-promote GSKs products IMITREX STATdose System® (sumatriptan succinate) and AMERGE®
(naratriptan hydrochloride) in the United States. Under the terms of the agreement, the Company
will license to GSK all clinical development and commercial rights to Botox® in Japan and China.
The Company will also manufacture Botox® for GSK as part of a long-term supply agreement and will
work collaboratively to support GSK on new clinical development for Botox® and strategic marketing
in those markets. The Company will receive an up-front payment, payments for research and
development and marketing support, and royalties on Japan and China Botox® sales. In connection
with the up-front payment, the Company expects to record deferred income and to amortize the
deferred income over the expected life of the licensing agreements in Japan and China.
In addition, the Company has obtained the right to co-promote GSKs products IMITREXSTATdose
System® and AMERGE® in the U.S. to neurologists and select related specialty physicians for a
five-year period. IMITREXSTATdose System® is approved for the treatment of acute migraine in
adults and for the acute treatment of cluster headache episodes. AMERGE® Tablets are approved for
the acute treatment of migraine attacks with and without an aura in adults. The Company will
receive annual fixed and performance payments from GSK.
The Company currently estimates that it will incur pre-tax restructuring costs, consisting
primarily of severance, contract termination and other costs of between approximately $6 million
and $8 million, associated with a planned restructuring and streamlining of the Companys ongoing
business activities in Japan that are necessary to accommodate the Companys recent third-party
licensing and distribution arrangements.
21
ALLERGAN, INC.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005
This financial review presents our operating results for the three and nine month periods ended
September 30, 2005 and September 24, 2004, and our financial condition at September 30, 2005.
Except for the historical information contained herein, the following discussion contains
forward-looking statements which are subject to known and unknown risks, uncertainties and other
factors that may cause our actual results to differ materially from those expressed or implied by
such forward-looking statements. We discuss such risks, uncertainties and other factors throughout
this report and specifically under the caption Certain Factors and Trends Affecting Allergan and
its Businesses in Item 3 below. In addition, the following review should be read in connection
with the information presented in our unaudited condensed consolidated financial statements and
related notes for the three and nine month periods ended September 30, 2005 and our audited
consolidated financial statements and related notes for the year ended December 31, 2004.
CRITICAL ACCOUNTING POLICIES
We believe that the estimates, assumptions and judgments involved in the accounting policies
described below have the greatest potential impact on our consolidated financial statements, so we
consider these to be our critical accounting policies. Because of the uncertainty inherent in these
matters, actual results could differ materially from the estimates we use in applying our critical
accounting policies.
Revenue Recognition
We recognize revenue from product sales when goods are shipped and title and risk of loss transfer
to the customer. We have a policy to attempt to maintain average U.S. wholesaler inventory levels
of our products at an amount less than eight weeks of our net sales. We generally offer cash
discounts to customers for the early payment of receivables. Those discounts are recorded as a
reduction of accounts receivable in the same period the related sale is recorded. The amounts
reserved for cash discounts at September 30, 2005 and December 31, 2004 were $1.7 million and $1.3
million, respectively. Provisions for cash discounts deducted from consolidated sales in the three
month periods ended September 30, 2005 and September 24, 2004 were $7.3 million and $5.6 million,
respectively. Provisions for cash discounts deducted from consolidated sales in the nine month
periods ended September 30, 2005 and September 24, 2004 were $19.7 million and $16.4 million,
respectively. We permit returns of product from any product line by any class of customer if such
product is returned in a timely manner, in good condition and from the normal distribution
channels. Return policies in certain international markets provide for more stringent guidelines in
accordance with the terms of contractual agreements with customers. Allowances for returns are
provided for based upon our historical patterns of returns matched against the sales from which
they originated, and managements evaluation of specific factors that increase the risk of returns.
The amount of allowances for sales returns accrued at September 30, 2005 and December 31, 2004 were
$5.6 million and $5.8 million, respectively. Provisions for sales returns deducted from
consolidated sales for the three month periods ended September 30, 2005 and September 24, 2004 were
$8.5 million and $5.6 million, respectively. Provisions for sales returns deducted from
consolidated sales for the nine month periods ended September 30, 2005 and September 24, 2004 were
$21.7 million and $17.9 million, respectively. Historical allowances for cash discounts and product
returns have been within the amounts reserved or accrued, respectively.
Additionally, we participate in various managed care sales rebate and other incentive programs, the
largest of which relates to Medicaid. Sales rebates and other incentive programs also include
chargebacks, which are contractual discounts given primarily to federal government agencies, health
maintenance organizations, pharmacy benefits managers and group purchasing organizations. Sales
rebates and incentive accruals reduce revenue in the same period the related sale is recorded and
are included in Accrued expenses in our unaudited condensed consolidated
22
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
balance sheets. The amounts accrued for sales rebates and other incentive programs at September 30,
2005 and December 31, 2004 were $63.3 million and $61.4 million, respectively. Provisions for sales
rebates and other incentive programs deducted from consolidated sales for the three month periods
ended September 30, 2005 and September 24, 2004 were $35.5 million and $35.3 million, respectively.
Provisions for sales rebates and other incentive programs deducted from consolidated sales for the
nine month periods ended September 30, 2005 and September 24, 2004 were $123.4 million and $105.7
million, respectively. The increase in the provision for sales rebates and other incentive programs
during the first nine months of 2005 compared to the first nine months of 2004 is primarily due to
an increase in the sales of U.S. pharmaceutical products, principally eye care pharmaceutical
products, subject to such rebates and incentive programs. In addition, an increase in our published
list prices in the United States for pharmaceutical products generally results in a higher ratio of
provisions for sales rebates and other incentive programs deducted from consolidated sales. Our
procedures for estimating amounts accrued for sales rebates and other incentive programs at the end
of any period are based on available quantitative data and are supplemented by managements
judgment with respect to many factors, including, but not limited to, current market place
dynamics, changes in contract terms, changes in sales trends, an evaluation of current laws and
regulations and product pricing. Quantitatively, we use historical sales, product utilization and
rebate data and apply forecasting techniques in order to estimate our liability amounts.
Qualitatively, managements judgment is applied to these items to modify, if appropriate, the
estimated liability amounts. There are inherent risks in this process. For example, customers may
not achieve assumed utilization levels; customers may misreport their utilization to us; and actual
movements of the U.S. Consumer Price Index Urban (CPI-U), which affect our rebate programs with
U.S. federal and state government agencies, may differ from those estimated. On a quarterly basis,
adjustments to our estimated liabilities for sales rebates and other incentive programs related to
sales made in prior periods have not been material and have generally been less than 0.5% of
consolidated net sales. An adjustment to our estimated liabilities of 0.5% of consolidated net
sales on a quarterly basis would result in an increase or decrease to net sales and earnings before
income taxes of approximately $3 million to $4 million. The sensitivity of our estimates can vary
by program and type of customer. Additionally, there is a significant time lag between the date we
determine the estimated liability and when we actually pay the liability. Due to this time lag, we
record adjustments to our estimated liabilities over several periods, which can result in a net
increase to earnings or a net decrease to earnings in those periods. Material differences may
result in the amount of revenue we recognize from product sales if the actual amount of rebates and
incentives differ materially from the amounts estimated by management.
We recognize certain license fees as other income based upon the facts and circumstances of each
licensing agreement. In general, we recognize income upon the signing of a license agreement that
grants rights to products or technology to a third party if we have no further obligation to
provide products or services to the third party after granting the license. We defer income under
license agreements when we have further obligations that indicate that a separate earnings process
has not culminated.
Pensions
We sponsor various pension plans in the United States and abroad in accordance with local laws and
regulations. Our pension plans in the United States account for a large majority of our pension
plans net periodic benefit costs and projected benefit obligations. In connection with these
plans, we use certain actuarial assumptions to determine the plans net periodic benefit costs and
projected benefit obligations, the most significant of which are the expected long-term rate of
return on assets and the discount rate.
Our assumption for the expected long-term rate of return on assets in our U.S. pension plan for
determining the net periodic benefit cost for 2005 is 8.25%, which is the same as our 2004 expected
rate of return. We determine, based upon recommendations from our pension plans investment
advisors, the expected rate of return using a building block approach that considers
diversification and rebalancing for a long-term portfolio of invested assets. Our investment
advisors study historical market returns and preserve long-term historical relationships between
equities
23
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
and fixed income in a manner consistent with the widely-accepted capital market principle that
assets with higher volatility generate a greater return over the long run. They also evaluate
market factors such as inflation and interest rates before long-term capital market assumptions are
determined. The expected rate of return is applied to the market-related value of plan assets. As a
sensitivity measure, the effect of a 0.25% decline in the rate of return on assets assumption would
increase our expected 2005 U.S. pre-tax pension benefit cost by approximately $0.7 million.
The discount rate used to calculate our U.S. pension benefit obligations at December 31, 2004 and
our net periodic benefit costs for 2005 is 5.95%. We determine the discount rate largely based upon
an index of high-quality fixed income investments (U.S. Moodys Aa Corporate Long Bond Yield
Average) at the plans measurement date. As a sensitivity measure, the effect of a 0.25% decline in
the discount rate assumption would increase our expected 2005 U.S. pre-tax pension benefit costs by
approximately $1.6 million and increase our U.S. pension plans projected benefit obligations at
December 31, 2004 by approximately $13.1 million.
Income Taxes
Income taxes are determined using an estimated annual effective tax rate, which is generally less
than the U.S. Federal statutory rate, primarily because of lower tax rates in certain non-U.S.
jurisdictions and research and development, or R&D, tax credits available in the United States. Our
effective tax rate may be subject to fluctuations during the fiscal year as new information is
obtained, which may affect the assumptions we use to estimate our annual effective tax rate,
including factors such as our mix of pre-tax earnings in the various tax jurisdictions in which we
operate, valuation allowances against deferred tax assets, reserves for tax contingencies,
utilization of R&D tax credits and changes in or interpretation of tax laws in jurisdictions where
we conduct operations. We recognize deferred tax assets and liabilities for temporary differences
between the financial reporting basis and the tax basis of our assets and liabilities, along with
net operating loss and credit carryforwards. We record a valuation allowance against our deferred
tax assets to reduce the net carrying value to an amount that we believe is more likely than not to
be realized. When we establish or reduce the valuation allowance against our deferred tax assets,
our income tax expense will increase or decrease, respectively, in the period such determination is
made.
Valuation allowances against our deferred tax assets were $55.9 million and $51.9 million at
September 30, 2005 and December 31, 2004, respectively. Changes in the valuation allowances are a
component of the estimated annual effective tax rate. Material differences in the estimated amount
of valuation allowances may result in an increase or decrease in the provision for income taxes if
the actual amounts for valuation allowances required against deferred tax assets differ from the
amounts estimated by us.
We have not provided for withholding and U.S. taxes for the unremitted earnings of certain non-U.S.
subsidiaries because we have currently reinvested or expect to reinvest these earnings indefinitely
in such operations. In connection with the American Jobs Creation Act of 2004, or the Act, we
determined during our second fiscal quarter of 2005 that we had sufficient information to make an
informed decision regarding the repatriation of certain foreign earnings that were previously
considered to be permanently reinvested. Based on that decision, we recorded a $32.8 million tax
liability associated with our decision to repatriate $674.0 million in extraordinary dividends, as
defined by the Act, from unremitted foreign earnings that were previously considered permanently
reinvested by certain non-U.S. subsidiaries. The $674.0 million amount of extraordinary dividends
is the qualified amount above a $53.4 million base amount determined based on our historical
repatriation levels, as defined by the Act. The tax effect of the base amount of dividends is
included in our estimated annual effective tax rate. We also decided to repatriate approximately
$85.8 million in additional dividends above the base and extraordinary dividend amounts from prior
and current years unremitted foreign earnings that were previously considered indefinitely
reinvested and recorded a corresponding estimated tax liability of $27.6 million in our second
fiscal quarter of 2005. During our third fiscal quarter of 2005, we repatriated $759.8 million in
extraordinary dividends and dividends above the base and
24
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
extraordinary dividend amounts and reduced the estimated income tax liability related to the
additional dividends above the base and extraordinary dividend amounts by $6.2 million to $21.4
million. This reduction in the estimated income tax liability related to the additional dividends
represents a change in estimate based upon the actual repatriation that occurred during the third
quarter of 2005.
During the third fiscal quarter of 2005, we reduced our reserves for uncertain tax positions and
related provision for income taxes by $19.5 million primarily due to a change in estimate resulting
from the resolution of several significant uncertain income tax audit issues, including transfer
prices, the deductibility of transaction costs associated with the 2002 spin-off of AMO and
intangible asset issues related to certain assets of Bardeen Sciences Company, LLC, which we
acquired in 2003. The change in estimate relates to tax years currently under examination or not
yet settled through expiry of the statute of limitations.
OPERATIONS
Headquartered in Irvine, California, we are a technology-driven, global health care company that
develops and commercializes specialty pharmaceutical products for the ophthalmic, neurological,
dermatological and other specialty markets. We currently employ approximately 4,985 persons around the world.
We are an innovative leader in therapeutic and over-the-counter products that are sold in more than
100 countries. Our principal markets are the United States, Europe, Latin America and Asia Pacific.
RESULTS OF OPERATIONS
We
currently operate our business on the basis of a single reportable segment specialty pharmaceuticals. We
currently produce a broad range of ophthalmic products for glaucoma therapy, ocular inflammation,
infection, allergy and dry eye; skin care products for acne, psoriasis and other prescription and
over-the-counter dermatological products; and Botox® for certain therapeutic and cosmetic
indications. We provide global marketing strategy teams to ensure development and execution of a
consistent marketing strategy for our products in all geographic regions that share similar
distribution channels and customers.
Management evaluates its various global product portfolios on a revenue basis, which is presented
below. We also report sales performance using the non-GAAP financial measure of constant currency
sales. Constant currency sales represent current period reported sales, adjusted for the
translation effect of changes in average foreign exchange rates between the current period and the
corresponding period in the prior year. We calculate the currency effect by comparing adjusted
current period reported amounts, calculated using the monthly average foreign exchange rates for
the corresponding period in the prior year, to the actual current period reported amounts. We
routinely evaluate our net sales performance at constant currency so that sales results can be
viewed without the impact of changing foreign currency exchange rates, thereby facilitating
period-to-period comparisons of our sales. Generally, when the U.S. dollar either strengthens or
weakens against other currencies, the growth at constant currency rates will be higher or lower,
respectively, than growth reported at actual exchange rates.
25
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
The following tables compare net sales by product line and certain selected products for the three
and nine month periods ended September 30, 2005 and September 24, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
(in millions) |
|
September 30, |
|
September 24, |
|
Change in Net Sales |
|
Percent Change in Net Sales |
|
|
2005 |
|
2004 |
|
Total |
|
Performance |
|
Currency |
|
Total |
|
Performance |
|
Currency |
Net Sales by Product Line: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye Care Pharmaceuticals |
|
$ |
358.1 |
|
|
$ |
285.4 |
|
|
$ |
72.7 |
|
|
$ |
68.7 |
|
|
$ |
4.0 |
|
|
|
25.5 |
% |
|
|
24.1 |
% |
|
|
1.4 |
% |
Botox/Neuromodulator |
|
|
214.8 |
|
|
|
174.6 |
|
|
|
40.2 |
|
|
|
37.7 |
|
|
|
2.5 |
|
|
|
23.0 |
% |
|
|
21.6 |
% |
|
|
1.4 |
% |
Skin Care |
|
|
33.0 |
|
|
|
24.8 |
|
|
|
8.2 |
|
|
|
8.2 |
|
|
|
|
|
|
|
33.1 |
% |
|
|
33.1 |
% |
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
605.9 |
|
|
|
484.8 |
|
|
|
121.1 |
|
|
|
114.6 |
|
|
|
6.5 |
|
|
|
25.0 |
% |
|
|
23.6 |
% |
|
|
1.4 |
% |
Other* |
|
|
0.2 |
|
|
|
26.0 |
|
|
|
(25.8 |
) |
|
|
(25.8 |
) |
|
|
|
|
|
|
(99.2 |
)% |
|
|
(99.2 |
)% |
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
606.1 |
|
|
$ |
510.8 |
|
|
$ |
95.3 |
|
|
$ |
88.8 |
|
|
$ |
6.5 |
|
|
|
18.7 |
% |
|
|
17.4 |
% |
|
|
1.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
|
69.0 |
% |
|
|
69.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International |
|
|
31.0 |
% |
|
|
30.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alphagan P, Alphagan and
Combigan |
|
$ |
75.1 |
|
|
$ |
73.2 |
|
|
$ |
1.9 |
|
|
$ |
1.3 |
|
|
$ |
0.6 |
|
|
|
2.6 |
% |
|
|
1.8 |
% |
|
|
0.8 |
% |
Lumigan |
|
|
72.8 |
|
|
|
60.3 |
|
|
|
12.5 |
|
|
|
11.9 |
|
|
|
0.6 |
|
|
|
20.7 |
% |
|
|
19.8 |
% |
|
|
0.9 |
% |
Other Glaucoma |
|
|
4.7 |
|
|
|
4.6 |
|
|
|
0.1 |
|
|
|
(0.1 |
) |
|
|
0.2 |
|
|
|
2.0 |
% |
|
|
(1.0 |
)% |
|
|
3.0 |
% |
Restasis |
|
|
54.0 |
|
|
|
24.1 |
|
|
|
29.9 |
|
|
|
29.8 |
|
|
|
0.1 |
|
|
|
123.8 |
% |
|
|
123.6 |
% |
|
|
0.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
(in millions) |
|
September 30, |
|
September 24, |
|
Change in Net Sales |
|
Percent Change in Net Sales |
|
|
2005 |
|
2004 |
|
Total |
|
Performance |
|
Currency |
|
Total |
|
Performance |
|
Currency |
Net Sales by Product Line: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye Care Pharmaceuticals |
|
$ |
981.1 |
|
|
$ |
835.1 |
|
|
$ |
146.0 |
|
|
$ |
131.1 |
|
|
$ |
14.9 |
|
|
|
17.5 |
% |
|
|
15.7 |
% |
|
|
1.8 |
% |
Botox/Neuromodulator |
|
|
603.6 |
|
|
|
502.2 |
|
|
|
101.4 |
|
|
|
92.3 |
|
|
|
9.1 |
|
|
|
20.2 |
% |
|
|
18.4 |
% |
|
|
1.8 |
% |
Skin Care |
|
|
93.2 |
|
|
|
73.9 |
|
|
|
19.3 |
|
|
|
19.2 |
|
|
|
0.1 |
|
|
|
26.1 |
% |
|
|
26.0 |
% |
|
|
0.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,677.9 |
|
|
|
1,411.2 |
|
|
|
266.7 |
|
|
|
242.6 |
|
|
|
24.1 |
|
|
|
18.9 |
% |
|
|
17.2 |
% |
|
|
1.7 |
% |
Other* |
|
|
46.4 |
|
|
|
78.2 |
|
|
|
(31.8 |
) |
|
|
(32.0 |
) |
|
|
0.2 |
|
|
|
(40.7 |
)% |
|
|
(40.9 |
)% |
|
|
0.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
1,724.3 |
|
|
$ |
1,489.4 |
|
|
$ |
234.9 |
|
|
$ |
210.6 |
|
|
$ |
24.3 |
|
|
|
15.8 |
% |
|
|
14.1 |
% |
|
|
1.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
|
67.7 |
% |
|
|
69.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International |
|
|
32.3 |
% |
|
|
30.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alphagan P, Alphagan and
Combigan |
|
$ |
206.1 |
|
|
$ |
204.9 |
|
|
$ |
1.2 |
|
|
$ |
(1.5 |
) |
|
$ |
2.7 |
|
|
|
0.6 |
% |
|
|
(0.7 |
)% |
|
|
1.3 |
% |
Lumigan |
|
|
196.3 |
|
|
|
171.1 |
|
|
|
25.2 |
|
|
|
22.4 |
|
|
|
2.8 |
|
|
|
14.7 |
% |
|
|
13.1 |
% |
|
|
1.6 |
% |
Other Glaucoma |
|
|
13.7 |
|
|
|
14.8 |
|
|
|
(1.1 |
) |
|
|
(1.7 |
) |
|
|
0.6 |
|
|
|
(7.7 |
)% |
|
|
(11.3 |
)% |
|
|
3.6 |
% |
Restasis |
|
|
137.6 |
|
|
|
65.5 |
|
|
|
72.1 |
|
|
|
72.0 |
|
|
|
0.1 |
|
|
|
110.1 |
% |
|
|
109.9 |
% |
|
|
0.2 |
% |
* Other sales primarily consist of sales to Advanced Medical Optics, Inc., or AMO, pursuant to
a manufacturing and supply agreement entered into as part of the AMO spin-off that terminated as
scheduled in June 2005.
The $6.5 million increase in net sales from the impact of foreign currency changes for the three
month period ended September 30, 2005 was due primarily to the strengthening of the Brazilian real,
Canadian dollar, Australian dollar and other Latin American currencies compared to the U.S. dollar.
The $24.3 million increase in net sales from the impact of foreign currency changes for the nine
month period ended September 30, 2005 was due primarily to the strengthening of the euro, Brazilian
real, Canadian dollar, British pound, Australian dollar and other Latin American and Asian
currencies compared to the U.S. dollar.
The $95.3 million increase in net sales in the third quarter of 2005 compared to the third quarter
of 2004 was primarily the result of increases in sales of our eye care pharmaceuticals, Botox® and
skin care product lines, partially offset by a decrease in other non-pharmaceutical sales. Eye care
pharmaceuticals sales increased in the third
26
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
quarter of 2005 compared to the third quarter of 2004 primarily because of strong growth in sales
in the United States of Restasis®, our drug for the treatment of chronic dry eye disease, an
increase in sales of our glaucoma drug Lumigan®, growth in sales of our Alphagan® franchise,
primarily from our international operations and new product sales from Combigan which is in the
launch phase in Canada and Brazil, a strong increase in sales of eye drop products, primarily
Refresh®, growth in sales of Zymar®, a newer anti-infective, an increase in sales of Elestat®, our
topical antihistamine used for the prevention of itching associated with allergic conjunctivitis
that was launched in the United States in the first quarter of 2004 by our co-promotion partner,
Inspire Pharmaceuticals, Inc., and an increase in sales of Acular LS®, our newer
non-steroidal anti-inflammatory. This increase in sales was partially offset by a decrease in sales
of Ocuflox®, our older generation anti-infective that is experiencing generic competition in the
United States, Acular®, our older generation anti-inflammatory, and other glaucoma products. We
continue to believe that generic formulations of Alphagan® will have a negative impact on future
net sales of our Alphagan® franchise. We estimate the majority of the change in our eye care
pharmaceutical sales was due to mix and volume changes; however, we increased the published list
prices for certain eye care pharmaceutical products in the United States, ranging from three and
one-half percent to nine percent, effective February 5, 2005. We increased the published U.S. list
price for Lumigan® by seven percent, Restasis® by three and one-half percent and Alphagan® P by
five percent. This increase in prices had a subsequent positive net effect on our U.S. sales, but
the actual net effect is difficult to determine due to the various managed care sales rebate and
other incentive programs in which we participate. Wholesaler buying patterns and the change in
dollar value of prescription product mix also affected our reported net sales dollars. We have a
policy to attempt to maintain average U.S. wholesaler inventory levels of our products at an amount
less than eight weeks of our net sales. At September 30, 2005, based on available external and
internal information, we believe the amount of average U.S. wholesaler inventories of our products
was near the lower end of our stated policy levels.
Botox® sales increased in the third quarter of 2005 compared to the third quarter of 2004 primarily
as a result of strong growth in demand in the United States and in international markets for both
therapeutic and cosmetic uses. Effective January 4, 2005, we increased the published price for
Botox® and Botox® Cosmetic in the United States by approximately four percent, which we believe had
a positive effect on our U.S. sales growth in 2005. International Botox® sales also benefited from
strong sales growth in Europe, especially in Germany and Spain, growth in sales in smaller
distribution markets serviced by our European export sales group, and an increase in sales in
Canada, Japan and Australia. We believe our worldwide market share for neuromodulators, including
Botox®, is currently over 85%.
Skin care sales increased in the third quarter of 2005 compared to the third quarter of 2004
primarily due to higher sales of Tazorac® in the United States and new product sales generated from
Prevage antioxidant cream, which we launched in January 2005. Net sales of Tazorac®, Zorac® and
Avage® increased $7.2 million, or 38.3%, to $26.0 million in the third quarter of 2005 compared to
$18.8 million in the third quarter of 2004. We increased the published U.S. list price for Tazorac®
by five percent effective July 31, 2004 and by an additional nine percent effective February 5, 2005.
The $234.9 million increase in total product net sales in the first nine months of 2005 compared to
the same period in 2004 was primarily the result of the same reasons discussed in the analysis of
the third quarter 2005 increase in net sales. In addition, net sales of Botox® benefited from
strong sales growth in the United Kingdom and Mexico in the first nine months of 2005 compared to
the first nine months of 2004. Net sales of Tazorac®, Zorac® and Avage® increased $13.5 million, or
25.0%, to $67.4 million in net sales for the first nine months of 2005 compared to $53.9 million in
net sales for the first nine months of 2004.
The decrease in the percentage of U.S. sales as a percentage of total product net sales during the
third quarter of 2005 compared to the third quarter of 2004 was primarily attributable to a decline
in U.S. other non-pharmaceutical sales, and an increase in international Botox® sales, principally
in Europe, as a percentage of total product net sales. The decrease in the percentage of U.S.
sales as a percentage of total product net sales during the first nine months of
27
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
2005 compared to the same period in 2004 was primarily attributable to a decline in U.S. other
non-pharmaceutical sales and an increase in international Botox® and eye care pharmaceutical sales,
principally in Europe, as a percentage of total product net sales.
Our gross margin percentage for the third quarter of 2005 was 83.7% of net sales, which represents
a 3.1 percentage point increase from our gross margin percentage of 80.6% for the third quarter of
2004. The gross margin percentage for the nine months ended September 30, 2005 was 82.4% of net
sales, which represents a 1.4 percentage point increase from the 81.0% rate reported for the first
nine months of 2004. Our gross margin percentage increased in the third quarter of 2005 compared to
the third quarter of 2004 primarily as a result of the $25.8 million decrease of other
non-pharmaceutical sales, primarily contract manufacturing sales, which have a significantly lower
gross margin percentage than our pharmaceutical sales, and a slight increase in the gross margin
percentage for our eye care pharmaceuticals. Our gross margin percentage also benefited from our
April 2005 royalty buy-out agreement with Novartis Pharmaceuticals Corporation and Novartis Pharma
AG relating to the topical ophthalmic use of cyclosporine A, the active ingredient in Restasis®.
This increase in gross margin percentage was partially offset by a small decline in the gross
margin percentage for our Botox® product line and an increase in the mix of eye care
pharmaceuticals net sales, which, despite the slight increase in the gross margin percentage for
eye care pharmaceuticals, continue to generally have a lower gross margin percentage than our
Botox® and skin care product lines. The gross margin percentage for our Botox® product line
experienced a small decrease in the third quarter of 2005 compared to the third quarter of 2004 due
primarily to an increase in the mix of international sales, which generally have a lower gross
margin percentage than U.S. sales, partially offset by the four percent published price increase
taken in January 2005 for Botox® and Botox® Cosmetic in the United States. The gross margin
percentage for skin care sales also declined in the third quarter of 2005 compared to the third
quarter of 2004 primarily due to new product sales of Prevage, which have a lower gross margin
percentage than our other prescription skin care products. Gross margin in dollars increased in the
third quarter of 2005 compared to the third quarter of 2004 by $95.9 million, or 23.3%, as a result
of the 18.7% increase in net sales and by the 3.1 percentage point increase in gross margin
percentage.
Our gross margin percentage increased in the first nine months of 2005 compared to the first nine
months of 2004 primarily as a result of the $31.8 million decrease in other non-pharmaceutical
sales, primarily contract manufacturing sales, which have a significantly lower gross margin
percentage than our pharmaceutical sales, a slight increase in the gross margin percentage of our
Botox® product line and a small increase in the mix of Botox® net sales, which generally have a
higher gross margin percentage than our other pharmaceutical product lines. The gross margin
percentage for our Botox® product line increased in the first nine months of 2005 compared to the
first nine months of 2004 primarily due to the published price increase in January 2005 for Botox®
and Botox® Cosmetic in the United States, partially offset by an increase in the mix of
international sales, which generally have a lower gross margin percentage than U.S. Botox® net
sales. This increase in gross margin percentage was partially offset by a decline in gross margin
percentage for eye care pharmaceuticals and skin care net sales. The gross margin percentage for
eye care pharmaceuticals declined in the first nine months of 2005 compared to the same period in
2004 due primarily to an increase in the mix of international sales, which generally have a lower
gross margin percentage than U.S. sales. The decline in gross margin percentage for skin care net
sales in the first nine months of 2005 compared to the first nine months of 2004 is primarily due
to the same reasons discussed in the analysis of the third quarter 2005 decrease in gross margin
percentage for skin care net sales. Gross margin in dollars increased in the first nine months of
2005 compared to the first nine months of 2004 by $213.5 million, or 17.7%, as a result of the
15.8% increase in net sales and by the 1.4 percentage point increase in gross margin percentage.
Selling, general and administrative, or SG&A, expenses were $237.7 million, or 39.2% of net sales,
in the third quarter of 2005 compared to $195.5 million, or 38.3% of net sales, in the third
quarter of 2004. SG&A expenses for the first nine months of 2005 were $689.5 million, or 40.0% of
net sales, compared to $572.8 million, or 38.5% of net sales, in the comparable 2004 period. The
increase in SG&A expense dollars in the third quarter of 2005
28
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
compared to the third quarter of 2004 was primarily a result of an increase in promotion costs
associated with direct-to-consumer advertising in the United States for Restasis®, Botox® Cosmetic
and the hyperhidrosis indication for Botox®, an increase in selling expenses, principally personnel
costs, and marketing expenses supporting the increase in consolidated sales, especially for
Restasis®, Botox® and Botox® Cosmetic, an increase in costs of providing product samples, and
higher general and administrative expenses, primarily incentive compensation, legal costs,
information services, corporate development expenses and charitable donations. We made a $2.0
million contribution to the Allergan Foundation in the third quarter of 2005. SG&A expenses also
increased due to an increase in co-promotion costs related to sales of Elestat® and costs
associated with expanding our contract and direct sales forces in Europe. SG&A expenses were also
negatively impacted by an increase in the translated U.S. dollar value of foreign currency
denominated expenses, especially in Europe and Latin America. This increase in SG&A expenses
during the third quarter of 2005 compared to the third quarter of 2004 was partially offset by a
$7.9 million pre-tax gain on the sale of our contact lens care and surgical products distribution
business in India to a subsidiary of AMO and a $5.8 million pre-tax gain on the sale of assets
primarily used for contract manufacturing and the former distribution of AMO related products at
our manufacturing facility in Ireland. As a percentage of net sales, SG&A expenses increased in the
third quarter of 2005 compared to the third quarter of 2004 due primarily to higher promotion and
marketing expenses as a percentage of net sales, partially offset by lower selling expenses and the
pre-tax gains from the sale of the assets described above.
The increase in SG&A expense dollars in the first nine months of 2005 compared to the first nine
months of 2004 was primarily due to the same reasons discussed in the analysis of the third quarter
2005 increase in SG&A expenses. SG&A expenses also increased in the first nine months of 2005
compared to the same period in 2004 due to the non-recurrence of a favorable settlement of a patent
dispute amounting to $2.4 million in the first quarter of 2004. As a percentage of net sales, SG&A
expenses increased in the first nine months of 2005 compared to the first nine months of 2004 due
primarily to higher promotion and marketing expenses as a percentage of net sales and lower
miscellaneous royalty income earned, partially offset by lower selling expenses, the pre-tax gains
from the sale of assets described in the analysis of the third quarter 2005 SG&A expenses, and
general and administrative expenses as a percentage of net sales.
Research and development expenses were $110.2 million, or 18.2% of net sales, in the third quarter
of 2005 compared to $83.0 million, or 16.2% of net sales, in the third quarter of 2004. For the
nine months ended September 30, 2005, research and development expenses were $283.5 million, or
16.4% of net sales, compared to $257.6 million, or 17.3% of net sales, in the comparable 2004
period. Research and development spending increased in the third quarter of 2005 compared to the
third quarter of 2004 primarily as a result of higher rates of investment in our eye care
pharmaceuticals and Botox® product lines and new technologies, partially offset by lower spending
for our skin care product line. Included in our spending for research and development in the third
quarter of 2005 is approximately $10.4 million consisting of $7.4 million in costs associated with
two new third party technology license and development agreements associated with in-process
technologies and $3.0 million related to the buy-out of a license agreement with Johns Hopkins
University associated with ongoing Botox® research activities. Research and development spending
increased in the first nine months of 2005 compared to the first nine months of 2004 primarily due
to the same reasons discussed in the analysis of the third quarter 2005 increase in research and
development expenses.
Restructuring Charges and Transition/Duplicate Operating Expenses
Restructuring and Streamlining of European Operations
Effective January 2005, our Board of Directors approved the initiation and implementation of a
restructuring of certain activities related to our European operations. The restructuring seeks to
optimize operations, improve resource allocation and create a scalable, lower cost and more
efficient operating model for our European research
29
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
and development, or R&D, and commercial activities. Specifically, the restructuring anticipates
moving key European R&D and select commercial functions from our Mougins, France and other European
locations to our Irvine, California, High Wycombe, United Kingdom and Dublin, Ireland facilities
and streamlining functions in our European management services group.
Under applicable law, the proposed restructuring requires consultations and, in certain cases,
negotiations with European and national works councils, other management/labor organizations and
local authorities, which we substantially completed by the end of our second quarter 2005.
We have incurred and anticipate that we will continue to incur restructuring charges and charges
relating to severance, relocation and one-time termination benefits, payments to public employment
and training programs, implementation, transition, capital and other asset-related expenses,
duplicate operating expenses and contract termination costs in connection with the restructuring.
We currently estimate that the pre-tax charges resulting from the restructuring, including
transition and duplicate operating expenses, will be between $40 million and $53 million and
capital expenditures will be between $5 million and $7 million. We began to incur these amounts
beginning in the first quarter of 2005 and expect to continue to incur them up through and
including the second quarter of 2006. Of the total amount of pre-tax charges and capital
expenditures, approximately $45 million to $58 million are expected to be cash expenditures.
The foregoing estimates are based on assumptions relating to, among other things, a reduction of
approximately 160 positions, principally R&D and selling, general and administrative positions in
the affected European locations. These workforce reduction activities began in the first quarter of
2005 and are expected to be substantially completed by the close of the second quarter of 2006.
Charges associated with the workforce reduction, including severance, relocation and one-time
termination benefits, and payments to public employment and training programs, are currently
expected to total approximately $28 million to $33 million. We began to incur these charges in the
first quarter of 2005 and expect to continue to incur them up through and including the second
quarter of 2006. Certain severance costs included in the estimates totaling approximately $2
million to $3 million for a limited number of personnel are dependent upon the employees future
decision to continue employment after specific contractual work assignments end between 2006 and
2007. These contingent contractual severance costs will be recorded in the period when we determine
that they become probable.
Estimated costs also include approximately $2 million to $7 million for contract and lease
termination costs and asset write-offs (primarily for accelerated amortization related to leasehold
improvements in facilities to be exited). These costs are currently expected to be recorded
beginning in the fourth quarter of 2005 and to be completed by the close of the second quarter of
2006.
Estimated implementation and transition related expenses include, among other things, legal,
consulting, recruiting and information system implementation costs and taxes. These costs are
currently expected to total approximately $9 million to $11 million. We began to record these costs
in the first quarter of 2005 and they are expected to continue up through and including the second
quarter of 2006. We also expect to incur duplicate operating expenses during the transition period
to ensure that job knowledge and skills are properly transferred to new employees. These duplicate
operating expenses are currently expected to total between $1 million and $2 million. We began to
record these costs in the first quarter of 2005 and they are expected to continue up through and
including the first quarter of 2006.
We also expect to incur additional capital expenditures for leasehold improvements (primarily at a
new facility in the United Kingdom to accommodate increased headcount). These capital expenditures
are currently estimated to be between approximately $5 million and $7 million. We began to record
these costs in the third quarter of 2005 and they are expected to continue up through and including
the second quarter of 2006.
30
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
During the first nine months of 2005, we recorded pre-tax restructuring charges of $24.5 million
related to the restructuring of our European operations. The restructuring charges primarily
consist of employee severance, employee relocation and other costs. The following table presents
the cumulative restructuring activities through September 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in millions) |
|
Employee |
|
Other |
|
|
|
|
Severance |
|
Costs |
|
Total |
Net charge during 2005 |
|
$ |
22.8 |
|
|
$ |
1.7 |
|
|
$ |
24.5 |
|
Spending |
|
|
(7.1 |
) |
|
|
(1.7 |
) |
|
|
(8.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2005 (included in accrued expenses) |
|
$ |
15.7 |
|
|
$ |
|
|
|
$ |
15.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee severance in the preceding table relates to 159 employees, of which 44 were severed as of
September 30, 2005. Employee severance charges were based on social plans in France and Italy, and
our severance practices for employees in the other affected European countries. During the first
nine months of 2005, we also recorded $3.1 million of transition/duplicate operating expenses
associated with the European restructuring activities. Transition/duplicate operating expenses
consisted primarily of salaries, travel, communications, recruitment and consulting costs.
Transition/duplicate operating expenses of $0.1 million in cost of sales, $2.0 million in selling,
general and administrative expenses and $1.0 million in research and development expenses have been
included in the unaudited condensed consolidated statements of earnings for the nine months ended
September 30, 2005.
Termination of Manufacturing and Supply Agreement with Advanced Medical Optics
In October 2004, our Board of Directors approved certain restructuring activities related to the
scheduled termination in June 2005 of our manufacturing and supply agreement with AMO. Under the
manufacturing and supply agreement, which was entered into in connection with the AMO spin-off, we
agreed to manufacture certain contact lens care products and VITRAX, a surgical viscoelastic, for
AMO for a period of up to three years ending in June 2005. As part of the termination of the
manufacturing and supply agreement, we eliminated certain manufacturing positions at our Westport,
Ireland; Waco, Texas; and Guarulhos, Brazil manufacturing facilities.
We currently anticipate that the pre-tax restructuring charges to be incurred in connection with
the termination of the manufacturing and supply agreement will total between approximately $22
million and $26 million. We began recording these charges in the fourth quarter of 2004 and expect
to continue recording them up through and including the third quarter of 2006. Restructuring
charges during 2006 primarily relate to the refurbishment of facilities previously used for
contract manufacturing. The pre-tax charges are net of expected tax credits available under
qualifying government-sponsored employment programs. Approximately $21 million of the restructuring
charges are expected to be cash charges. The restructuring charges are expected to include
approximately $18 million to $20 million associated with the reduction in our workforce of
approximately 350 individuals. The workforce reduction, which began in the fourth quarter of 2004
and was substantially completed in the second quarter of 2005, impacted personnel in Europe, the
United States and Latin America. The restructuring costs are also expected to include approximately
$4 million to $6 million of other costs associated with the termination of the manufacturing and
supply agreement.
As of September 30, 2005, we recorded cumulative pre-tax restructuring charges of $22.0 million
related to the termination of the manufacturing and supply agreement. These charges primarily
include accruals for net statutory severance costs and the ratable recognition of termination
benefits to be earned by employees who are required to render service until they are terminated in
order to receive the termination benefits. Cumulative charges for employees involuntarily and
voluntarily terminated in the table below relate to 343 employees, of which 312 were severed as of
September 30, 2005. Included in other costs within the table below is $0.3 million of inventory
write-offs
31
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
that have been recorded as a component of Cost of sales in the unaudited condensed
consolidated statements of earnings.
The following table presents the cumulative restructuring activities through September 30, 2005
resulting from the scheduled termination of our manufacturing and supply agreement with AMO in June
2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charges for Employees |
|
|
|
|
(in millions) |
|
Involuntarily and |
|
Other |
|
|
|
|
Voluntarily Terminated |
|
Costs |
|
Total |
Net charge during 2004 |
|
$ |
7.1 |
|
|
$ |
|
|
|
$ |
7.1 |
|
Spending |
|
|
(0.1 |
) |
|
|
|
|
|
|
(0.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004 |
|
|
7.0 |
|
|
|
|
|
|
|
7.0 |
|
Net charge during 2005 |
|
|
12.3 |
|
|
|
2.6 |
|
|
|
14.9 |
|
Assets written off |
|
|
|
|
|
|
(2.3 |
) |
|
|
(2.3 |
) |
Spending (net of employment tax credits received) |
|
|
(17.7 |
) |
|
|
(0.3 |
) |
|
|
(18.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2005 |
|
$ |
1.6 |
|
|
$ |
|
|
|
$ |
1.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The remaining balance at September 30, 2005 is comprised of accrued statutory severance and
one-time termination benefits of $2.3 million (included in accrued expenses), less expected
employment program tax credits receivable of $0.7 million (included in other current assets).
During the three months ended September 30, 2005, we reduced by $1.5 million the remaining balance
of other accrued costs associated with restructuring costs and asset write-offs previously recorded
in connection with the spin-off of AMO in 2002. This reduction in other accrued costs was included
in the Restructuring charge (reversal) for the three and nine months ended September 30, 2005. At
September 30, 2005, the remaining balance for other accrued costs associated with the 2002 spin-off
of AMO was $1.3 million.
Operating income in the third quarter of 2005 was $159.8 million compared to operating income of
$133.2 million for the third quarter of 2004. The $26.6 million increase in operating income was
due primarily to the $95.9 million increase in gross margin and $0.1 million net restructuring
charge reversal, partially offset by the $42.2 million increase in SG&A expenses and $27.2 million
increase in research and development expenses. Our operating income in the first nine months of
2005 was $409.4 million compared to operating income of $376.1 million for the same period in 2004.
The $33.3 million increase in operating income was due primarily to the $213.5 million increase in
gross margin, partially offset by the $116.7 million increase in SG&A expenses, $25.9 million
increase in research and development expenses and $37.6 million net restructuring charge.
Total net non-operating income in the third quarter of 2005 was $12.8 million compared to net
non-operating expenses of $0.7 million in the third quarter of 2004. Interest income in the third
quarter of 2005 was $11.4 million compared to interest income of $2.6 million in the third quarter
of 2004. This increase in interest income in the third quarter of 2005 was primarily due to higher
average cash equivalent balances earning interest of approximately $296.8 million and an increase
in average interest rates earned on all cash equivalent balances earning interest of approximately
0.95% in the third quarter of 2005 compared to the same period in 2004. Interest income in the
third quarter of 2005 also benefited from the recognition of $2.1 million of statutory interest
income related to the expected recovery of previously paid state income taxes, which became
recoverable due to a favorable state court decision that became final during 2004. Interest expense
decreased $8.4 million to a negative amount of $1.6 million in the third quarter of 2005 compared
to interest expense of $6.8 million in the third quarter of 2004, primarily due to a reversal
during the third quarter of 2005 of $6.5 million of previously accrued statutory interest expense
associated with a reduction in accrued income taxes payable related to the resolution of several
significant uncertain income tax audit issues. This decrease in interest expense was
partially offset by an increase in interest expense related to additional foreign borrowings in
Ireland required to effectuate the planned repatriation of
32
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
dividends during the third quarter of 2005. During the third quarter of 2004, we accelerated our
amortization of debt issuance costs to a more conservative view, electing to amortize such costs
related to our outstanding zero coupon convertible senior notes over the five year period from date
of issuance to the first note holder put date in November 2007 instead of over the 20 year life of
the notes. As a result, we recorded an adjustment to interest expense of $3.1 million for the
cumulative difference in amortized debt issuance costs as of the beginning of the third quarter of
2004. The impact of this adjustment is immaterial to our consolidated financial statements for the
three and nine month periods ended September 24, 2004, respectively.
We recorded a net unrealized loss on derivative instruments of $0.2 million in the third quarter of
2005 compared to a net unrealized loss of $0.1 million in the third quarter of 2004. We record as
Unrealized gain (loss) on derivative instruments, net the mark to market adjustments on our
outstanding foreign currency options, which we enter into to reduce the volatility of expected
earnings in currencies other than U.S. dollars. During the third quarter of 2005, we recorded a
$0.8 million gain on the sale of a third party equity investment in a public company. Other, net
expense was $0.8 million in the third quarter of 2005 compared to Other, net income of $3.6 million
in the third quarter of 2004. In the third quarter of 2004, Other net includes a gain of $5.0
million for the receipt of a technology transfer fee related to the assignment of a third party
patent licensing arrangement covering the use of botulinum toxin type B for cervical dystonia.
Other, net includes net realized losses from foreign currency transactions of $1.1 million and $1.3
million for the third quarters of 2005 and 2004, respectively.
Total net non-operating income in the first nine months of 2005 was $20.3 million compared to net
non-operating expenses of $5.0 million in the first nine months of 2004. Interest income in the
first nine months of 2005 was $23.0 million compared to interest income of $6.8 million in the same
period of 2004. This increase in interest income in the first nine months of 2005 was primarily due
to higher average cash equivalent balances earning interest of approximately $365.7 million and an
increase in average interest rates earned on all cash equivalent balances earning interest of
approximately 0.54% in the first nine months of 2005 compared to the same period in 2004. Interest
income in the first nine months of 2005 also includes $2.1 million of statutory interest income as
discussed in the analysis of the third quarter. Interest expense decreased $6.7 million to $7.5
million in the first nine months of 2005 compared to $14.2 million in the same period of 2004,
primarily due to the reversal of statutory interest expense of $6.5 million recorded in the third
quarter of 2005.
During the first nine months of 2005, we recorded a net unrealized gain on derivative instruments
of $1.0 million compared to a net unrealized gain of $0.1 million in the same period of 2004. Gain
on investments was $0.8 million consisting of a gain from the sale of a third party equity
investment in a public company. Other, net income was $3.0 million in the first nine months of
2005 compared to Other, net income of $2.3 million in the same period of 2004. In the first nine
months of 2005, Other, net includes a gain of $3.5 million for the receipt of a technology transfer
fee related to the assignment of a third party patent licensing arrangement covering the use of
botulinum toxin type B for cervical dystonia and net realized losses from foreign currency
transactions of $1.5 million. Other, net in the first nine months of 2004 includes net realized
losses from foreign currency transactions of $3.3 million, a gain of $5.0 million for the receipt
of a technology transfer fee, as discussed in the analysis of the third quarter, and a gain of $0.8
million realized from the settlement of a non-income tax dispute with AMO.
Our effective tax rates for the third quarter and first nine months of 2005 were 11.5% and 38.0%,
respectively, compared to the effective tax rates of 30.4% and 28.5% for the third quarter and
first nine months of 2004, respectively, and our full year 2004 adjusted effective tax rate of
29.8%. Our full year 2004 adjusted effective tax rate excludes the impact of restructuring charges
of $7.0 million and related tax benefit of $0.8 million and an estimated $6.1 million income tax
benefit for previously paid state income taxes, which became recoverable due to a favorable state
court decision that became final during the second quarter of 2004. We believe that the use of an
adjusted effective tax rate, which excludes the impact of certain discrete items, provides a more
meaningful measure of the impact of income taxes on our results of operations. Included in our
operating income in the third quarter and
33
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
first nine months of 2005 are pre-tax restructuring charges (reversals) of $(0.1) million and $37.9
million, respectively, a gain of $7.9 million on the sale of our distribution business in India and
a gain of $5.8 million on the sale of assets used primarily for contract manufacturing of AMO
products. We recorded an income tax benefit of zero and $4.1 million in the third quarter and first
nine months of 2005, respectively, related to the pre-tax restructuring charges (reversals). In the
third quarter and first nine months of 2005, we recorded a provision for income taxes of $1.7
million and $0.6 million on the gain on sale of the distribution business in India and the gain on
sale of assets used primarily for contract manufacturing, respectively. Included in the provision
for income taxes in the first nine months of 2005 is an estimated $32.8 million income tax
provision associated with our decision to repatriate $674.0 million in extraordinary dividends as
defined by the American Jobs Creation Act of 2004, or the Act, from unremitted foreign earnings
that were previously considered indefinitely reinvested by certain non-U.S. subsidiaries. Also
included in the provision for income taxes in the third quarter and first nine months of 2005 is an
estimated provision (benefit) of $(6.2) million and $21.4 million associated with our decision to
repatriate approximately $85.8 million in additional dividends above the base and extraordinary
dividend amounts, as defined by the Act, from unremitted foreign earnings that were previously
considered indefinitely reinvested. During our third fiscal quarter of 2005, we reduced our
estimated income tax liability related to these additional dividends by $6.2 million to $21.4
million from the original estimated tax liability of $27.6 million recorded in our second fiscal
quarter of 2005. This reduction in the estimated income tax liability related to the additional
dividends represents a change in estimate based upon the actual repatriation that occurred during
the third quarter of 2005. Included in the provision for income taxes in the third quarter and
first nine months of 2005 is a $1.4 million beneficial change in estimate for the expected income
tax benefit for previously paid state income taxes, which became recoverable due to a favorable
state court decision that became final during 2004, and an estimated $19.5 million reduction in
estimated income taxes payable primarily due to the resolution of several significant uncertain
income tax audit issues, including the resolution of certain transfer pricing issues for which an
Advance Pricing Agreement, or APA, was executed with the Internal Revenue Service in the U.S.
during the third quarter of 2005. The APA covers tax years 2002 through 2008. The $19.5 million
reduction in estimated income taxes payable also includes beneficial changes associated with other
transfer price settlements for a discontinued product line, which was not covered by the APA, the
deductibility of transaction costs associated with the 2002 spin-off of AMO and intangible asset
issues related to certain assets of Bardeen Sciences Company, LLC, which we acquired in 2003. This
change in estimate relates to tax years currently under examination or not yet settled through
expiry of the statute of limitations.
Excluding the impact of the pre-tax restructuring charges (reversals) and gains from the sale of
the distribution business in India and the sale of assets used for contract manufacturing, and the
related income tax provision (benefit) associated with these pre-tax amounts, the provision
(benefit) for income taxes due to the extraordinary dividends and additional dividends above the
base and extraordinary dividend amounts, the decrease in the provision for income taxes resulting
from the additional income tax benefit for previously paid state income taxes which became
recoverable, and reduction in estimated income taxes payable due to the resolution of several
significant uncertain income tax audit issues, our adjusted effective tax rates for the third
quarter and first nine months of 2005 were 28.1% and 29.0%, respectively. The calculation of our
2005 adjusted effective tax rates is summarized below:
34
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First |
(in millions) |
|
Third Quarter |
|
Nine Months |
|
|
2005 |
|
2005 |
Earnings before income taxes and minority interest, as reported |
|
$ |
172.6 |
|
|
$ |
429.7 |
|
Restructure charge (reversal) |
|
|
(0.1 |
) |
|
|
37.9 |
|
Gain on sale of distribution business in India |
|
|
(7.9 |
) |
|
|
(7.9 |
) |
Gain on sale of assets used for contract manufacturing |
|
|
(5.8 |
) |
|
|
(5.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
$ |
158.8 |
|
|
$ |
453.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes, as reported |
|
$ |
19.9 |
|
|
$ |
163.2 |
|
Income tax (provision) benefit for: |
|
|
|
|
|
|
|
|
Restructure charge (reversal) |
|
|
|
|
|
|
4.1 |
|
Gain on sale of distribution business in India |
|
|
(1.7 |
) |
|
|
(1.7 |
) |
Gain on sale of assets used for contract manufacturing |
|
|
(0.6 |
) |
|
|
(0.6 |
) |
Recovery of previously paid state income taxes |
|
|
1.4 |
|
|
|
1.4 |
|
Resolution of uncertain income tax audit issues |
|
|
19.5 |
|
|
|
19.5 |
|
Extraordinary dividend of $674.0 million under the American Jobs
Creation Act of 2004 |
|
|
|
|
|
|
(32.8 |
) |
Additional dividends of $85.8 million above the base and
extraordinary dividend amounts |
|
|
6.2 |
|
|
|
(21.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
$ |
44.7 |
|
|
$ |
131.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted effective tax rate |
|
|
28.1 |
% |
|
|
29.0 |
% |
|
|
|
|
|
|
|
|
|
Our adjusted effective tax rate of 29.0% for the first nine months of 2005 decreased 0.8 percentage
points compared to our full year 2004 adjusted effective tax rate of 29.8% primarily due to a tax
rate benefit related to an increase in the mix of our earnings generated in non-U.S. jurisdictions
with low tax rates included in our estimated annual effective tax rate for fiscal year 2005
compared to 2004.
The Internal Revenue Service, or IRS, as part of its current audit of our 2000 to 2002 tax years is
currently challenging the tax deductibility of certain intangible assets acquired as part of the
2001 acquisition of Allergan Specialty Therapeutics, Inc. Certain tax benefits related to the
amortization of these intangible assets have been previously recognized and established as a
deferred tax asset. We believe in the appropriateness of the deductions; however, if the IRS
challenge is successful, the possible negative income tax provision impact for de-recognizing the
deferred tax asset will be approximately $10.6 million.
Net earnings in the third quarter of 2005 were $150.5 million compared to net earnings of $92.0
million for the same period last year. The $58.5 million increase in earnings in the third quarter
of 2005 compared to the third quarter of 2004 was primarily the result of the increase in operating
income of $26.6 million and net non-operating income of $13.5 million and the decrease in the
provision for income taxes of $20.4 million, partially offset by an increase in minority interest
expense of $2.0 million.
Net earnings in the first nine months of 2005 were $263.8 million compared to net earnings of
$264.6 million for the same period last year. The $0.8 million decrease in earnings in the first
nine months of 2005 compared to the first nine months of 2004 was primarily the result of the
increase in the provision for income taxes of $57.4 million and minority interest expense of $2.0
million, partially offset by the increase in operating income of $33.3 million and net
non-operating income of $25.3 million.
35
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
LIQUIDITY AND CAPITAL RESOURCES
We assess our liquidity by our ability to generate cash to fund our operations. Significant factors
in the management of liquidity are: funds generated by operations; levels of accounts receivable,
inventories, accounts payable and capital expenditures; the extent of our stock repurchase program;
funds required for acquisitions; adequate credit facilities; and financial flexibility to attract
long-term capital on satisfactory terms.
Historically, we have generated cash from operations in excess of working capital requirements. The
net cash provided by operating activities for the nine months ended September 30, 2005 was $304.7
million compared to cash provided of $375.1 million for the nine months ended September 24, 2004.
The decrease in net cash provided by operating activities of $70.4 million was primarily due to an
increase in contributions to our pension plans, an increase in income taxes paid and a net increase
in cash required to fund changes in other net operating assets and liabilities, partially offset by
a decrease in cash required to fund growth in our trade receivables. The increase in income taxes
paid is primarily due to payments for the estimated U.S. income tax liability for the repatriation
of certain foreign earnings and advance payments in anticipation of income tax audit settlements.
In the first nine months of 2005 and 2004, we paid pension contributions of $40.1 million and $4.9
million, respectively, to our U.S. defined benefit pension plan. In 2005, we currently expect to
pay contributions in the range of $46.4 million and $48.4 million for our U.S. and non-U.S. pension
plans, compared to $16.9 million in 2004. The increase in estimated contributions in 2005 compared
to 2004 is primarily due to the negative impact of lower discount rates on the calculation of our
accumulated benefit obligations as of September 30, 2005, the measurement date for our pension
plans, and our desire to maintain plan assets in excess of accumulated benefit obligations in our
funded pension plans.
At December 31, 2004, we disclosed consolidated unrecognized net actuarial losses of $166.3 million
for our defined benefit pension plans, which were included in our reported net prepaid benefit
cost. The unrecognized net actuarial losses resulted primarily from lower than expected investment
returns on plan assets in 2002 and 2001 and decreases in the discount rates used to measure
projected benefit obligations that occurred over the past four years. Unrecognized net actuarial
gains or losses are evaluated annually by our actuaries for each of our pension and postretirement
plans based on information at the plans annual measurement date. Assuming constant actuarial
assumptions estimated as of our pension plans measurement date of September 30, 2004, we expect
the amortization of these unrecognized net actuarial losses to increase our total pension costs by
approximately $3.0 million in 2005 compared to the amortization of approximately $6.7 million of
unrecognized net actuarial losses included in pension costs expensed in fiscal year 2004. The
future amortization of the unrecognized net actuarial losses is not expected to materially affect
future pension contribution requirements.
Net cash used in investing activities in the first nine months of 2005 was $139.3 million. Net cash
used in investing activities in the first nine months of 2004 was $70.4 million. We invested $36.2
million in new facilities and equipment during the nine months ended September 30, 2005 compared to
$64.0 million during the same period in 2004. In the first nine months of 2005, we paid $110.0
million in connection with a certain royalty buyout agreement relating to Restasis®, our drug for
the treatment of chronic dry eye disease, of which $99.3 million was capitalized as an intangible
licensing asset, and $10.7 million was used to pay previously accrued net royalty obligations. Net
cash used in investing activities also includes $10.8 million and $4.9 million to acquire software
during the nine months ended September 30, 2005 and September 24, 2004, respectively. We currently
expect to invest between $55 million and $65 million in expenditures for manufacturing and
laboratory facilities and other property, plant and equipment during 2005.
Net cash provided by financing activities was $50.4 million in the first nine months of 2005
compared to net cash used in financing activities of $33.8 million in the first nine months of
2004. Dividends paid to stockholders were $39.1 million in the first nine months of 2005 compared
to $35.5 million for the same period in 2004. Effective
36
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
October 28, 2005, our Board of Directors declared a quarterly cash dividend of $0.10 per share,
payable on December 12, 2005 to stockholders of record on November 16, 2005. Receipts from the sale
of stock to employees were $70.5 million in the first nine months of 2005 compared to $80.0 million
in the same period last year. During the first nine months of 2005, we had net borrowings of $113.3
million in notes payable compared to net repayments of $2.7 million in the first nine months of
2004. During the first nine months of 2005, we repurchased $94.3 million of treasury stock. During
the first nine months of 2004, we repurchased $65.2 million of treasury stock and repaid $10.4
million under our commercial paper arrangements. Under our stock repurchase program, we may
maintain up to 9.2 million repurchased shares in our treasury account at any one time. As of
September 30, 2005, we held approximately 2.7 million treasury shares under this program. We are
uncertain as to the level of treasury stock repurchases to be made in the future.
As of September 30, 2005, we had a committed long-term credit facility, a committed foreign line of
credit in Japan, a commercial paper program, a medium term note program, an unused debt shelf
registration statement that we may use for a new medium term note program and other issuances of
debt securities, and various foreign bank facilities. The committed credit facility allows for
borrowings of up to $400 million through May 2009. The committed foreign line of credit allows for
borrowings of up to three billion yen (approximately $26.4 million) through July 2006. The
commercial paper program also provides for up to $300 million in borrowings. We do not currently
intend to have combined borrowings under our committed credit facilities and our commercial paper
program that would exceed $300 million in the aggregate. The current medium term note program
allows us to issue up to an additional $8.0 million in registered notes on a non-revolving basis.
The debt shelf registration statement provides for up to $350 million in additional debt
securities. Borrowings under the long-term credit facility and medium term note program are subject
to certain financial and operating covenants that include, among other provisions, maintaining
minimum debt to capitalization ratios and a minimum consolidated net worth. Certain covenants also
limit subsidiary debt and restrict dividend payments. We believe we were in compliance with these
covenants at September 30, 2005. As of September 30, 2005, we had $120.0 million outstanding in
borrowings under our committed credit facility, $6.0 million outstanding in borrowings under
various foreign bank loans, $57.2 million in borrowings outstanding under the medium term note
program and no borrowings under our commercial paper program or committed foreign line of credit.
On November 6, 2002, we issued zero coupon convertible senior notes due 2022, or Senior Notes, in a
private placement with an aggregate principal amount at maturity of $641.5 million. The Senior
Notes, which were issued at a discount of $141.5 million, are unsecured, accrue interest at 1.25%
annually and mature on November 6, 2022. The Senior Notes are convertible into 11.41 shares of our
common stock for each $1,000 principal amount at maturity if the closing price of our common stock
exceeds certain levels, the credit ratings assigned to the Senior Notes are reduced below specified
levels, or we call the Senior Notes for redemption, make specified distributions to our
stockholders or become a party to certain consolidation, merger or binding share exchange
agreements. On July 28, 2004, we, together with Wells Fargo Bank, as trustee, executed a
supplemental indenture to the indenture governing the Senior Notes. The supplemental indenture
amends the indentures redemption and conversion provisions to restrict our ability to issue common
stock in lieu of cash to holders of the Senior Notes upon any redemption or conversion. Upon any
redemption, we are now required to pay the entire redemption amount in cash. In addition, upon any
conversion, we will pay cash up to the accreted value of the Senior Notes converted and will have
the option to pay any amounts due in excess of the accreted value in either cash or common stock.
The rights of the holders of the Senior Notes were not affected or limited by the supplemental
indenture. As of September 30, 2005 the conversion criteria had been met and holders may elect to
convert the Senior Notes into common stock between October 1, 2005 and December 31, 2005. We do not
currently expect any of the holders of our Senior Notes to elect conversion during our fourth
fiscal quarter of 2005. Based on the terms of the Senior Notes, an assessment of the conversion
criteria is performed each fiscal quarter, the result of which affects the holders ability to
convert the Senior Notes in the immediately succeeding fiscal quarter. If the conversion criteria
are not met in the fiscal quarter ending December 31, 2005, the holders ability to convert the
Senior Notes will be restricted until the
37
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED SEPTEMBER 30, 2005 (Continued)
conversion criteria are again met. We include the dilutive effect from the assumed conversion of
the Senior Notes, if any, in our computation of diluted earnings per share, assuming amounts due in
excess of the accreted value will be paid in common stock. As a sensitivity measure, a $5.00
increase in the average price of our common stock would have resulted in an increase of
approximately 0.3 million and 0.4 million shares of common stock to the total number of diluted
shares used to compute diluted earnings per share for the three and nine month periods ended
September 30, 2005, respectively.
Holders of the Senior Notes may require us to purchase the Senior Notes on any one of the following
dates at the following prices: $829.51 per Senior Note on November 6, 2007; $882.84 per Senior Note
on November 6, 2012; and $939.60 per Senior Note on November 6, 2017. Pursuant to the supplemental
indenture, we are required to pay cash for any Senior Notes purchased by us on any of these three
dates. We may not redeem the Senior Notes before November 6, 2005, and prior to November 6, 2007 we
may redeem all or a portion of the Senior Notes for cash in an amount equal to their accreted value
only if the price of our common stock reaches certain thresholds for a specified period of time. On
or after November 6, 2007, we may redeem all or a portion of the Senior Notes for cash in an amount
equal to their accreted value.
During our third fiscal quarter of 2005, we repatriated a total of $759.8 million in cash
previously held by certain non-U.S. subsidiaries, primarily in connection with the American Jobs
Creation Act of 2004. See Note 7, Income Taxes, in the notes to our unaudited condensed
consolidated financial statements, in Item 1(D) of Part I of this report, for a discussion of our
repatriation of certain unremitted foreign earnings and the estimated income tax costs of such
repatriation activities.
Our manufacturing and supply agreement with AMO terminated as scheduled in June 2005. We currently
estimate that we will incur between $22 million and $26 million of total restructuring costs
associated with the termination of that agreement and related exit activities. We expect
approximately $21 million of the restructuring charges to be cash charges. As of September 30,
2005, we recorded cumulative pre-tax restructuring charges of $22.0 million beginning in the fourth
quarter of 2004 up through and including the third quarter of 2005 and expect to complete the
additional restructuring activities by the end of the third quarter of 2006.
Effective January 2005, our Board of Directors approved the initiation and implementation of a
restructuring of certain activities related to our European operations. We currently estimate that
the pre-tax charges resulting from the restructuring, including transition and duplicate operating
expenses, will be between $40 million and $53 million and capital expenditures will be between $5
million and $7 million. These amounts began to be incurred beginning in the first quarter of 2005
and are expected to continue up through and including the second quarter of 2006. Of the total
amount of pre-tax charges and capital expenditures, approximately $45 million to $58 million are
expected to be cash expenditures. During the first nine months of 2005, we recorded pre-tax
restructuring charges of $24.5 million and transition/duplicate operating expenses of $3.1 million
related to the implementation of this restructuring of our European operations. We expect to
complete the additional restructuring activities by the end of the second quarter of 2006.
We believe that the net cash provided by operating activities, supplemented as necessary with
borrowings available under our existing credit facilities and existing cash and equivalents, will
provide us with sufficient resources to meet working capital requirements, debt service and other
cash needs over the next year.
38
ALLERGAN, INC.
Item 3. Quantitative and Qualitative Disclosures About Market Risk and Certain Factors and Trends
Affecting Allergan and its Businesses
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
In the normal course of business, our operations are exposed to risks associated with fluctuations
in foreign currency exchange rates. We address these risks through controlled risk management that
includes the use of derivative financial instruments to economically hedge or reduce these
exposures. We do not enter into financial instruments for trading or speculative purposes.
To ensure the adequacy and effectiveness of our foreign exchange hedge positions, we continually
monitor our foreign exchange forward and option positions both on a stand-alone basis and in
conjunction with our foreign currency exposures, from an accounting and economic perspective.
However, given the inherent limitations of forecasting and the anticipatory nature of the exposures
intended to be hedged, we cannot assure you that such programs will offset more than a portion of
the adverse financial impact resulting from unfavorable movements in foreign exchange rates. In
addition, the timing of the accounting for recognition of gains and losses related to
mark-to-market instruments for any given period may not coincide with the timing of gains and
losses related to the underlying economic exposures and, therefore, may adversely affect our
consolidated operating results and financial position.
We record current changes in the fair value of open foreign currency option contracts as
Unrealized gain (loss) on derivative instruments, net and record the gains and losses realized
from settled option contracts in Other, net in the accompanying unaudited condensed consolidated
statements of earnings. The premium costs of purchased foreign exchange option contracts are
recorded in Other current assets and are amortized to Other, net over the life of the options.
We have recorded all unrealized and realized gains and losses from foreign currency forward
contracts through Other, net in the accompanying unaudited condensed consolidated statements of
earnings.
Interest Rate Risk
Our interest income and expense is more sensitive to fluctuations in the general level of U.S.
interest rates than to changes in rates in other markets. Changes in U.S. interest rates affect the
interest earned on our cash and equivalents, interest expense on our debt as well as costs
associated with foreign currency contracts.
At September 30, 2005, we had approximately $126.0 million of variable rate debt. If the interest
rates on our variable rate debt were to increase or decrease by 1% for the year, annual interest
expense would increase or decrease by approximately $1.3 million.
39
Allergan, Inc.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (Continued)
The tables below present information about certain of our investment portfolio and our debt
obligations at September 30, 2005 and December 31, 2004.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEPTEMBER 30, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair |
|
|
Maturing in |
|
|
|
|
|
Market |
|
|
2005 |
|
2006 |
|
2007 |
|
2008 |
|
2009 |
|
Thereafter |
|
Total |
|
Value |
|
|
(in millions, except interest rates) |
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase Agreements |
|
$ |
100.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
100.0 |
|
|
$ |
100.0 |
|
Weighted Average Interest
Rate |
|
|
3.83 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.83 |
% |
|
|
|
|
Commercial Paper |
|
|
891.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
891.6 |
|
|
|
891.6 |
|
Weighted Average Interest
Rate |
|
|
2.36 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.36 |
% |
|
|
|
|
Foreign Time Deposits |
|
|
31.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.9 |
|
|
|
31.9 |
|
Weighted Average Interest
Rate |
|
|
4.78 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.78 |
% |
|
|
|
|
Other Cash Equivalents |
|
|
51.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51.0 |
|
|
|
51.0 |
|
Weighted Average Interest
Rate |
|
|
3.52 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.52 |
% |
|
|
|
|
Total Cash Equivalents |
|
$ |
1,074.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,074.5 |
|
|
$ |
1,074.5 |
|
Weighted Average Interest
Rate |
|
|
4.96 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.96 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Obligations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed Rate (US$) |
|
|
|
|
|
|
|
|
|
$ |
518.4 |
|
|
$ |
32.2 |
|
|
|
|
|
|
$ |
25.0 |
|
|
$ |
575.6 |
|
|
$ |
739.5 |
|
Weighted Average Interest
Rate |
|
|
|
|
|
|
|
|
|
|
1.25 |
% |
|
|
3.56 |
% |
|
|
|
|
|
|
7.47 |
% |
|
|
1.65 |
% |
|
|
|
|
Other Fixed Rate (non-US$) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Interest
Rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Variable Rate
(non-US$) |
|
$ |
126.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
126.0 |
|
|
|
126.0 |
|
Weighted Average Interest
Rate |
|
|
3.99 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.99 |
% |
|
|
|
|
Total Debt Obligations |
|
$ |
126.0 |
|
|
|
|
|
|
$ |
518.4 |
|
|
$ |
32.2 |
|
|
|
|
|
|
$ |
25.0 |
|
|
$ |
701.6 |
|
|
$ |
865.5 |
|
Weighted Average Interest
Rate |
|
|
3.99 |
% |
|
|
|
|
|
|
1.25 |
% |
|
|
3.56 |
% |
|
|
|
|
|
|
7.47 |
% |
|
|
2.07 |
% |
|
|
|
|
40
Allergan, Inc.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (Continued)
|
|
|
|
|
|
|
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|
|
|
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|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair |
|
|
Maturing in |
|
|
|
|
|
Market |
|
|
2005 |
|
2006 |
|
2007 |
|
2008 |
|
2009 |
|
Thereafter |
|
Total |
|
Value |
|
|
(in millions, except interest rates) |
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase Agreements |
|
$ |
100.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
100.0 |
|
|
$ |
100.0 |
|
Weighted Average Interest Rate |
|
|
2.37 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.37 |
% |
|
|
|
|
Commercial Paper |
|
|
648.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
648.9 |
|
|
|
648.9 |
|
Weighted Average Interest Rate |
|
|
2.23 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.23 |
% |
|
|
|
|
Foreign Time Deposits |
|
|
26.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26.0 |
|
|
|
26.0 |
|
Weighted Average Interest Rate |
|
|
2.47 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.47 |
% |
|
|
|
|
Other Cash Equivalents |
|
|
54.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
54.9 |
|
|
|
54.9 |
|
Weighted Average Interest Rate |
|
|
2.18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.18 |
% |
|
|
|
|
Total Cash Equivalents |
|
$ |
829.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
829.8 |
|
|
$ |
829.8 |
|
Weighted Average Interest Rate |
|
|
2.25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Obligations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed Rate (US$) |
|
|
|
|
|
|
|
|
|
$ |
513.6 |
|
|
$ |
31.5 |
|
|
|
|
|
|
$ |
25.0 |
|
|
$ |
570.1 |
|
|
$ |
690.7 |
|
Weighted Average Interest Rate |
|
|
|
|
|
|
|
|
|
|
1.25 |
% |
|
|
3.56 |
% |
|
|
|
|
|
|
7.47 |
% |
|
|
1.65 |
% |
|
|
|
|
Other Fixed Rate (non-US$) |
|
$ |
1.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.4 |
|
|
|
1.4 |
|
Weighted Average Interest Rate |
|
|
13.32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.32 |
% |
|
|
|
|
Other Variable Rate (non-US$) |
|
|
11.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11.7 |
|
|
|
11.7 |
|
Weighted Average Interest Rate |
|
|
1.46 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.46 |
% |
|
|
|
|
Total Debt Obligations |
|
$ |
13.1 |
|
|
|
|
|
|
$ |
513.6 |
|
|
$ |
31.5 |
|
|
|
|
|
|
$ |
25.0 |
|
|
$ |
583.2 |
|
|
$ |
703.8 |
|
Weighted Average Interest Rate |
|
|
2.73 |
% |
|
|
|
|
|
|
1.25 |
% |
|
|
3.56 |
% |
|
|
|
|
|
|
7.47 |
% |
|
|
1.67 |
% |
|
|
|
|
Foreign Currency Risk
Overall, we are a net recipient of currencies other than the U.S. dollar and, as such, benefit from
a weaker dollar and are adversely affected by a stronger dollar relative to major currencies
worldwide. Accordingly, changes in exchange rates, and in particular a strengthening of the U.S.
dollar, may negatively affect our consolidated sales and gross margins as expressed in U.S.
dollars.
From time to time, we enter into foreign currency option and foreign currency forward contracts to
reduce earnings and cash flow volatility associated with foreign exchange rate changes to allow our
management to focus its attention on our core business issues and challenges. Accordingly, we enter
into various contracts which change in value as foreign exchange rates change to economically
offset the effect of changes in the value of foreign currency assets and liabilities, commitments
and anticipated foreign currency denominated sales and operating expenses. We enter into foreign
currency option and foreign currency forward contracts in amounts between minimum and maximum
anticipated foreign exchange exposures, generally for periods not to exceed one year.
We use foreign currency option contracts, which provide for the sale of foreign currencies to
offset foreign currency exposures expected to arise in the normal course of our business. While
these instruments are subject to fluctuations in value, such fluctuations are anticipated to offset
changes in the value of the underlying exposures. The principal currencies subject to this process
are the Canadian dollar, Mexican peso, Australian dollar, Brazilian real, euro, Japanese yen and
U.K. pound.
41
Allergan, Inc.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (Continued)
All of our outstanding foreign exchange forward contracts are entered into to protect the value of
intercompany receivables denominated in currencies other than the lenders functional currency. The
realized and unrealized gains and losses from foreign currency forward contracts and the
revaluation of the foreign denominated intercompany receivables are recorded through Other, net
in the accompanying unaudited condensed consolidated statements of earnings.
The following tables provide information about our foreign currency derivative financial
instruments outstanding as of September 30, 2005 and December 31, 2004. The information is provided
in U.S. dollar amounts, as presented in our consolidated financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2005 |
|
December 31, 2004 |
|
|
|
|
|
|
Average Contract |
|
|
|
|
|
Average Contract |
|
|
Notional |
|
Rate or |
|
Notional |
|
Rate or |
|
|
Amount |
|
Strike Amount |
|
Amount |
|
Strike Amount |
|
|
(in millions) |
|
|
|
|
|
(in millions) |
|
|
|
|
Foreign currency forward contracts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Receive US$/Pay Foreign Currency) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Euro |
|
$ |
9.2 |
|
|
|
1.23 |
|
|
$ |
13.2 |
|
|
|
1.32 |
|
Australian Dollar |
|
|
1.9 |
|
|
|
0.77 |
|
|
|
|
|
|
|
|
|
Canadian Dollar |
|
|
8.5 |
|
|
|
1.18 |
|
|
|
|
|
|
|
|
|
New Zealand Dollar |
|
|
0.3 |
|
|
|
0.70 |
|
|
|
|
|
|
|
|
|
U.K. Pound |
|
|
17.2 |
|
|
|
1.81 |
|
|
|
3.4 |
|
|
|
1.90 |
|
Japanese Yen |
|
|
8.8 |
|
|
|
108.77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
45.9 |
|
|
|
|
|
|
$ |
16.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated fair value |
|
$ |
(0.8 |
) |
|
|
|
|
|
$ |
(0.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency purchased put options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canadian Dollar |
|
$ |
6.2 |
|
|
|
1.22 |
|
|
$ |
22.0 |
|
|
|
1.22 |
|
Mexican Peso |
|
|
3.0 |
|
|
|
11.99 |
|
|
|
10.1 |
|
|
|
11.75 |
|
Australian Dollar |
|
|
3.5 |
|
|
|
0.74 |
|
|
|
11.0 |
|
|
|
0.74 |
|
Brazilian Real |
|
|
2.5 |
|
|
|
3.18 |
|
|
|
6.6 |
|
|
|
3.06 |
|
Euro |
|
|
9.0 |
|
|
|
1.33 |
|
|
|
22.4 |
|
|
|
1.32 |
|
Japanese Yen |
|
|
2.7 |
|
|
|
101.33 |
|
|
|
7.4 |
|
|
|
102.21 |
|
U.K. Pound |
|
|
1.1 |
|
|
|
1.90 |
|
|
|
2.9 |
|
|
|
1.90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
28.0 |
|
|
|
|
|
|
$ |
82.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated fair value |
|
$ |
1.2 |
|
|
|
|
|
|
$ |
1.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency sold call options: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.K. Pound |
|
$ |
|
|
|
|
|
|
|
$ |
1.0 |
|
|
|
1.92 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated fair value |
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES
Statements made by us in this report and in other reports and statements released by us that are
not historical facts constitute forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933, Section 21 of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995. These forward-looking statements are necessarily
estimates reflecting the best judgment of senior management and include comments that express our
opinions about trends and factors that may impact future operating results. Disclosures that use
words such as we believe, anticipate, estimate, intend, could, plan, expect and
similar expressions are intended to identify forward-looking statements. Such statements rely on a
number of assumptions concerning future events, many of which are outside of our control, and
involve risks and uncertainties that could cause actual results to differ materially from opinions
and expectations. Any such forward-looking statements, whether made in this report or elsewhere,
should be considered in the context of the various disclosures made by us about our businesses
including, without limitation, the risk factors discussed below. We do not plan to update any such
forward-looking statements and expressly disclaim any duty to update the information contained in
this filing except as required by law.
We operate in a rapidly changing environment that involves a number of risks. The following
discussion highlights some of these risks and others are discussed elsewhere in this report. These
and other risks could materially and adversely affect our business, financial condition, prospects,
operating results or cash flows.
We operate in a highly competitive business.
The pharmaceutical industry is highly competitive. This competitive environment requires an
ongoing, extensive search for technological innovation. It also requires, among other things, the
ability to effectively develop, test, and obtain regulatory approvals for products, as well as the
ability to effectively commercialize, market and promote approved products, including communicating
the effectiveness, safety and value of products to actual and prospective customers and medical
professionals. Many of our competitors have greater resources than we have. This enables them,
among other things, to spread their research and development costs, as well as their marketing and
promotion costs, over a broader revenue base. Our competitors may also have more experience and
expertise in obtaining marketing approvals from the FDA and other regulatory authorities. In
addition to product development, testing, approval and promotion, other competitive factors in the
pharmaceutical industry include industry consolidation, product quality and price, reputation,
customer service and access to technical information. It is possible that developments by our
competitors could make our products or technologies less competitive or obsolete. In addition,
competition from generic drug manufacturers is a major challenge in the United States and is
growing internationally. For instance, Falcon Pharmaceuticals, Ltd., an affiliate of Alcon
Laboratories, Inc., is currently attempting to obtain FDA approval for and to launch a brimonidine
product to compete with our Alphagan® P product.
Until December 2000, Botox® was the only neuromodulator approved by the FDA. At that time, the FDA
approved Myobloc®, a neuromodulator formerly marketed by Elan Pharmaceuticals and now marketed by
Solstice Neurosciences, Inc. We believe that Beaufour Ipsen Ltd. intends to seek FDA approval of
its Dysport® neuromodulator for certain therapeutic indications, and that Beaufour Ipsens
marketing partner, Inamed Corporation, intends to seek FDA approval of Dysport®/Reloxin® for
cosmetic indications. Beaufour Ipsen has marketed Dysport® in Europe since 1991, prior to our
European commercialization of Botox® in 1992. Also, Mentor Corporation has announced its intention
to develop and seek regulatory approval to market a competing neuromodulator in the United States.
In addition, we are aware of competing neuromodulators currently being developed and commercialized
in Asia, Europe, South America and other markets. A Chinese entity received approval to market a
botulinum toxin in China in 1997, and we believe that it has launched or is planning to launch its
botulinum toxin product in other lightly regulated markets in Asia, South America and Central
America. These lightly regulated markets may not require adherence to the FDAs current Good
Manufacturing Practices, or cGMPs,
43
Allergan, Inc.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
the European Medical Evaluation Agency or other regulatory agencies in countries that are members
of the Organization for Economic Cooperation and Development, and companies operating in these
markets may be able to produce products at a lower cost than we can. In addition, Merz
Pharmaceuticals received approval from German authorities for a botulinum toxin and launched its
product in July 2005, and a Korean company is conducting Phase III clinical trials for a botulinum
toxin in Korea. This product received exportation approval from Korean authorities in early 2005.
Our sales of Botox® could be materially and negatively impacted by this competition or competition
from other companies that might obtain FDA approval or approval from other regulatory authorities
to market a neuromodulator.
Botox® Cosmetic is a consumer product; trends may change and applicable laws may affect sales or
product margins of Botox® or Botox® Cosmetic.
Botox® Cosmetic is a consumer product. If we fail to anticipate, identify or to react to
competitive products or if consumer preferences in the cosmetic marketplace shift to other
treatments for the temporary improvement in the appearance of moderate to severe glabellar lines,
we may experience a decline in demand for Botox® Cosmetic. In addition, the popular media has at
times in the past produced, and may continue in the future to produce, negative reports and
entertainment regarding the efficacy, safety or side effects of Botox® Cosmetic. Consumer
perceptions of Botox® Cosmetic may be negatively impacted by these reports and other reasons,
including the use of unapproved botulinum toxins that result in injury, which may cause demand to
decline.
Demand for Botox® Cosmetic may be materially adversely affected by changing economic conditions.
Generally, the costs of cosmetic procedures are borne by individuals without reimbursement from
their medical insurance providers or government programs. Individuals may be less willing to incur
the costs of these procedures in weak or uncertain economic environments, and demand for Botox®
Cosmetic could be adversely affected.
Because Botox® and Botox® Cosmetic are pharmaceutical products, we generally do not collect or pay
sales or other tax on sales of Botox® or Botox® Cosmetic. We could be required to collect and pay
sales or other tax associated with prior, current or future years on sales of Botox® or Botox®
Cosmetic. In addition to any retroactive taxes and corresponding interest and penalties that could
be assessed, if we were required to collect or pay sales or other tax associated with current or
future years on sales of Botox® or Botox® Cosmetic, our sales of, or our product margins on, Botox®
or Botox® Cosmetic could be adversely affected due to the increased cost associated with those
products.
We could experience difficulties creating the raw material needed to produce Botox®.
The manufacturing process to create the raw material necessary to produce Botox® is technically
complex and requires significant lead-time. Any failure by us to forecast demand for, or to
maintain an adequate supply of, the raw material and finished product could result in an
interruption in the supply of Botox® and a resulting decrease in sales of the product.
Our future success depends upon our ability to develop new products, and new indications for
existing products, that achieve market acceptance.
Our future performance will be affected by the market acceptance of products such as Lumigan®,
Alphagan® P, Combigan, Restasis®, Acular LS®, Zymar® and Botox®, as well as FDA approval of new
indications for Botox®, and new products such as our Lumigan®/Timolol combination, Posurdex® and
memantine. We have allocated substantial resources to the development and introduction of new
products and indications. For our business model to be successful, new products must be continually
developed, tested and manufactured and, in addition, must meet regulatory standards and receive
requisite regulatory approvals in a timely manner. For instance, to obtain approval of new
indications or products in the United States, we must submit, among other information,
44
Allergan, Inc.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
the results of preclinical and clinical studies on the new indication or product candidate to the
FDA. The number of preclinical and clinical studies that will be required for FDA approval varies
depending on the new indication or product candidate, the disease or condition for which the new
indication or product candidate is in development and the regulations applicable to that new
indication or product candidate. If the FDA delays or does not approve of new indications for our
products or drug candidates, the price per share of our common stock may be impacted upon the
announcement of such delays or non-approvals. We are also required to pass pre-approval reviews and
plant inspections of our and our suppliers facilities to demonstrate our compliance with the FDAs
cGMP regulations. Products that we are currently developing or other future product candidates may
or may not receive the regulatory approvals necessary for marketing. Furthermore, the development,
regulatory review and approval, and commercialization processes are time consuming, costly and
subject to numerous factors that may delay or prevent the development and commercialization of new
products, including legal actions brought by our competitors. The FDA can delay, limit or deny
approval of a new indication or product candidate for many reasons, including:
|
|
|
a determination that the new indication or product candidate is not safe and effective; |
|
|
|
the FDA may interpret our preclinical and clinical data in different ways than we do; |
|
|
|
the FDA may not approve our manufacturing processes or facilities; or |
|
|
|
the FDA may change its approval policies or adopt new regulations. |
In connection with our 2003 acquisitions of Bardeen Sciences Company, LLC and Oculex
Pharmaceuticals, Inc., we acquired the right to continue researching and developing certain
compounds and products, respectively, for commercialization. We cannot assure you that these or any
other compounds or products that we are developing for commercialization will be able to be
commercialized on terms that will be profitable, or at all. If any of our products cannot be
successfully or timely commercialized, our operating results could be materially adversely
affected. Delays or unanticipated costs in any part of the process or our inability to obtain
timely regulatory approval for our products, including those attributable to, among other things,
our failure to maintain manufacturing facilities in compliance with all applicable regulatory
requirements, could cause our operating results to suffer and our stock price to decrease. We
cannot assure you that new products or indications will be successfully developed, will receive
regulatory approval or will achieve market acceptance. Further, even if we receive FDA and other
regulatory approvals for a new indication or product, the product may later exhibit adverse effects
that limit or prevent its widespread use or that force us to withdraw the product from the market
or to revise our labeling to limit the indications for which the product may be prescribed.
If we are unable to obtain and maintain adequate patent protection for the technologies
incorporated into our products, our business and results of operations could suffer.
Patent protection is generally important in the pharmaceutical industry. Upon the expiration or
loss of patent protection for a product, we can lose a significant portion of sales of that product
in a very short period of time as other companies manufacture generic forms of our previously
protected product at lower cost, without having had to incur significant research and development
costs in formulating the product. Therefore, our future financial success may depend in part on
obtaining patent protection for technologies incorporated into our products. We cannot assure you
that such patents will be issued, or that any existing or future patents will be of commercial
benefit. In addition, it is impossible to anticipate the breadth or degree of protection that any
such patents will afford, and we cannot assure you that any such patents will not be successfully
challenged in the future. If we are unsuccessful in obtaining or preserving patent protection, or
if any of our products rely on unpatented proprietary technology, we cannot assure you that others
will not commercialize products substantially identical to those products. Generic drug
manufacturers are currently challenging the patents covering certain of our products and we expect
that they will continue to do so in the future. Our business also relies on trade secrets and
proprietary know-how that we seek to protect, in part, through confidentiality agreements with
third parties, including our partners, customers, employees and consultants. It is possible that
these agreements will be breached or that they will not be enforceable in every
45
Allergan, Inc.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
instance, and that we will not have adequate remedies for any such breach. It is also possible that
our trade secrets will become known or independently developed by our competitors.
Interruptions in the supply of raw materials could disrupt our manufacturing and cause our sales
and profitability to decline.
We obtain the specialty chemicals that are the active pharmaceutical ingredients in certain of our
products from single sources, who must maintain compliance with the FDAs cGMP regulations. If we
experience difficulties acquiring sufficient quantities of these materials from our existing
suppliers, or if our suppliers are found to be non-compliant with the cGMPs, obtaining the required
regulatory approvals, including from the FDA, to use alternative suppliers may be a lengthy and
uncertain process. A lengthy interruption of the supply of one or more of these materials could
adversely affect our ability to manufacture and supply products, which could cause our sales and
profitability to decline.
Importation of products from Canada and other countries into the United States may lower the prices
we receive for our products.
In the United States, our products are subject to competition from lower priced versions of our
products and competing products from Canada, Mexico, and other countries where government price
controls or other market dynamics result in lower prices. Our products that require a prescription
in the United States are often available to consumers in these markets without a prescription,
which may cause consumers to further seek out our products in these lower priced markets. The
ability of patients and other customers to obtain these lower priced imports has grown
significantly as a result of the Internet, an expansion of pharmacies in Canada and elsewhere
targeted to American purchasers, the increase in U.S.-based businesses affiliated with Canadian
pharmacies marketing to American purchasers, and other factors. Most of these foreign imports are
illegal under current U.S. law. However, the volume of imports continues to rise due to the limited
enforcement resources of the FDA and the U.S. Customs Service, and there is increased political
pressure to permit the imports as a mechanism for expanding access to lower priced medicines.
In December 2003, Congress enacted the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003. This law contains provisions that may change U.S. import laws and expand consumers
ability to import lower priced versions of our products and competing products from Canada, where
there are government price controls. These changes to U.S. import laws will not take effect unless
and until the Secretary of Health and Human Services certifies that the changes will lead to
substantial savings for consumers and will not create a public health safety issue. The former
Secretary of Health and Human Services did not make such a certification. However, it is possible
that the current Secretary or a subsequent Secretary could make the certification in the future. As
directed by Congress, a task force on drug importation recently conducted a comprehensive study
regarding the circumstances under which drug importation could be safely conducted and the
consequences of importation on the health, medical costs and development of new medicines for U.S.
consumers. The task force issued its report in December 2004, finding that there are significant
safety and economic issues that must be addressed before importation of prescription drugs is
permitted, and the current Secretary has not yet announced any plans to make the required
certification. In addition, federal legislative proposals have been made to implement the changes
to the U.S. import laws without any certification, and to broaden permissible imports in other
ways. Even if the changes to the U.S. import laws do not take effect, and other changes are not
enacted, imports from Canada and elsewhere may continue to increase due to market and political
forces, and the limited enforcement resources of the FDA, the U.S. Customs Service and other
government agencies. For example, state and local governments have suggested that they may import
drugs from Canada for employees covered by state health plans or others, and some already have
implemented such plans.
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Allergan, Inc.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
The importation of foreign products adversely affects our profitability in the United States. This
impact could become more significant in the future, and the impact could be even greater if there
is a further change in the law or if state or local governments take further steps to import
products from abroad.
Our business will continue to expose us to risks of environmental liabilities.
Our product development programs and manufacturing processes involve the controlled use of
hazardous materials, chemicals and toxic compounds. These programs and processes expose us to risks
that an accidental contamination could lead to noncompliance with environmental laws, regulatory
enforcement actions and claims for personal injury and property damage. If an accident occurs, or
if we discover contamination caused by prior operations, including by prior owners and operators of
properties we acquire, we could be liable for cleanup obligations, damages and fines. The
substantial unexpected costs we may incur could have a significant and adverse effect on our
business and results of operations.
We may experience losses due to product liability claims, product recalls or corrections.
The design, development, manufacture and sale of our products involve an inherent risk of product
liability claims by consumers and other third parties. We have in the past been, and continue to
be, subject to various product liability claims and lawsuits. In addition, we have in the past and
may in the future recall or issue field corrections related to our products due to manufacturing
deficiencies, labeling errors or other safety or regulatory reasons. We cannot assure you that we
will not experience material losses due to product liability claims, lawsuits, product recalls or
corrections.
Additionally, our products may cause, or may appear to cause, serious adverse side effects or
potentially dangerous drug interactions if misused or improperly prescribed. These events, among
others, could result in additional regulatory controls, such as the performance of costly
post-approval clinical studies or revisions to our approved labeling, which could limit the
indications or patient population for our products or could even lead to the withdrawal of a
product from the market. Furthermore, any adverse publicity associated with such an event could
cause consumers to seek alternatives to our products, which may cause our sales to decline, even if
our products are ultimately determined not to have been the primary cause of the event.
Health care initiatives and other cost-containment pressures could cause us to sell our products at
lower prices, resulting in less revenue to us.
Some of our products are purchased or reimbursed by state and federal government authorities,
private health insurers and other organizations, such as health maintenance organizations, or HMOs,
and managed care organizations, or MCOs. Third party payors increasingly challenge pharmaceutical
product pricing. The trend toward managed healthcare in the United States, the growth of
organizations such as HMOs and MCOs, and various legislative proposals and enactments to reform
healthcare and government insurance programs, including the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, could significantly influence the manner in which
pharmaceutical products are prescribed and purchased, which could result in lower prices and/or a
reduction in demand for our products. In a recent rule establishing a competitive acquisition
program, or CAP, beginning January 2006, physicians who administer drugs in their offices will be
offered an option to acquire drugs covered under the Medicare Part B benefit from vendors who are
selected in a competitive bidding process. Winning vendors would be selected based on criteria that
include their bid price. Such cost containment measures and healthcare reforms could adversely
affect our ability to sell our products. Furthermore, individual states have become increasingly
aggressive in passing legislation and implementing regulations designed to control pharmaceutical
product pricing, including price or patient reimbursement constraints, discounts, restrictions on
certain product access, importation from other countries and bulk purchasing. Legally mandated
price controls on payment amounts by third party payors or other restrictions could negatively and
materially impact our revenues and
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Allergan, Inc.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
financial condition. We encounter similar regulatory and legislative issues in most countries
outside the United States. In addition, regional healthcare
authorities and individual hospitals are increasingly using bidding procedures to
determine what pharmaceutical products and which suppliers will be included in the prescription
drug and other healthcare programs. This can reduce demand for our products or put pressure on our
product pricing, which could negatively affect our revenues and profitability.
We are subject to risks arising from currency exchange rates, which could increase our costs and
may cause our profitability to decline.
We collect and pay a substantial portion of our sales and expenditures in currencies other than the
U.S. dollar. Therefore, fluctuations in foreign currency exchange rates affect our operating
results. We cannot assure you that future exchange rate movements, inflation or other related
factors will not have a material adverse effect on our sales, gross profit or operating expenses.
We are subject to risks associated with doing business internationally.
Our business is subject to certain risks inherent in international business, many of which are
beyond our control. These risks include, among other things:
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Any of these factors, or any other international factors, could have a material adverse effect on
our business, financial condition and results of operations. We cannot assure you that we can
successfully manage these risks or avoid their effects.
We may be subject to intellectual property litigation and infringement claims, which could cause us
to incur significant expenses and losses or prevent us from selling our products.
Although we have a corporate policy not to infringe the valid and enforceable patents of others, we
cannot assure you that our products will not infringe patents held by third parties. In the event
we discover that we may be infringing third party patents, licenses from those third parties may
not be available on commercially attractive terms or at all. We may have to defend, and have
recently defended, against charges that we violated patents or the proprietary rights of third
parties. Litigation is costly and time-consuming, and diverts the attention of our management and
technical personnel. In addition, if we infringe the intellectual property rights of others, we
could lose our right to develop, manufacture or sell products or could be required to pay monetary
damages or royalties to license proprietary rights from third parties. An adverse determination in
a judicial or administrative proceeding or a failure to obtain necessary licenses could prevent us
from manufacturing or selling our products, which could harm our business, financial condition,
prospects, results of operations and cash flows. See Item 1 of Part II of this report, Legal
Proceedings and Note 9, Litigation, in the notes to the unaudited condensed consolidated
financial
48
Allergan, Inc.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
statements listed under Item 1(D) of Part I of this report for information concerning our current
intellectual property litigation.
The consolidation of drug wholesalers and other wholesaler actions could increase competitive and
pricing pressures on pharmaceutical manufacturers, including us.
We sell our pharmaceutical products primarily through wholesalers. These customers comprise a
significant part of the distribution network for pharmaceutical products in the United States. This
distribution network is continuing to undergo significant consolidation marked by mergers and
acquisitions. As a result, a smaller number of large wholesale distributors control a significant
share of the market. We expect that consolidation of drug wholesalers will increase competitive and
pricing pressures on pharmaceutical manufacturers, including us. In addition, wholesalers may apply
pricing pressure through the implementation of fee-for-service arrangements, and their purchases
may exceed customer demand, resulting in reduced wholesaler purchases in later quarters. We cannot
assure you that we can manage these pressures or that wholesaler purchases will not decrease as a
result of this potential excess buying.
We may acquire companies in the future and these acquisitions could disrupt our business.
As part of our business strategy, we regularly consider and, as appropriate, make acquisitions of
technologies, products and businesses that we believe are complementary to our business.
Acquisitions typically entail many risks and could result in difficulties in integrating the
operations, personnel, technologies and products of the companies acquired, some of which may
result in significant charges to earnings. If we are unable to successfully integrate our
acquisitions with our existing business, we may not obtain the advantages that the acquisitions
were intended to create, which may materially adversely affect our business, results of operations,
financial condition and cash flows, our ability to develop and introduce new products and the
market price of our stock. In connection with acquisitions, we could experience disruption in our
business or employee base, or key employees of companies that we acquire may seek employment
elsewhere, including with our competitors. Furthermore, the products of companies we acquire may
overlap with our products or those of our customers, creating conflicts with existing relationships
or with other commitments that are detrimental to the integrated businesses.
Compliance with the extensive government regulations to which we are subject is expensive and time
consuming, and may result in the delay or cancellation of product sales, introductions or
modifications.
Extensive industry regulation has had, and will continue to have, a significant impact on our
business, especially our product development and manufacturing capabilities. All pharmaceutical
companies, including Allergan, are subject to extensive, complex, costly and evolving regulation by
federal governmental authorities, principally by the FDA and the U.S. Drug Enforcement
Administration, or DEA, and similar foreign and state government agencies. Failure to comply with
the regulatory requirements of the FDA, DEA and other U.S. and foreign regulatory requirements may
subject a company to administrative or judicially imposed sanctions, including, among others, a
refusal to approve a pending application to market a new product or a new indication for an
existing product. The Federal Food, Drug, and Cosmetic Act, the Controlled Substances Act and other
domestic and foreign statutes and regulations govern or influence the research, testing,
manufacturing, packing, labeling, storing, record keeping, safety, effectiveness, approval,
advertising, promotion, sale and distribution of our products. Under certain of these regulations,
we are subject to periodic inspection of our facilities, production processes and control
operations and/or the testing of our products by the FDA, the DEA and other authorities, to confirm
that we are in compliance with all applicable regulations, including the FDAs cGMP regulations.
The FDA conducts pre-approval and post-approval reviews and plant inspections of us and our
suppliers to determine whether our record keeping, production processes and controls, personnel and
quality control are in compliance with the cGMPs and other FDA regulations. We are also required to
perform extensive audits of our vendors, contract laboratories and suppliers to ensure that they
are compliant with these requirements. In addition, in order to commercialize our products or new
indications
49
Allergan, Inc.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
for an existing product, we must demonstrate that the product or new indication is safe and
effective, and that our and our suppliers manufacturing facilities are compliant with applicable
regulations, to the satisfaction of the FDA and other regulatory agencies.
The process for obtaining governmental approval to manufacture pharmaceutical products is rigorous,
typically takes many years and is costly, and we cannot predict the extent to which we may be
affected by legislative and regulatory developments. We are dependent on receiving FDA and other
governmental approvals prior to manufacturing, marketing and shipping our products. We may fail to
obtain approval from FDA or other governmental authorities for our product candidates, or
experience delays in obtaining such approvals, due to varying interpretations of data or failure to
satisfy rigorous efficacy, safety and manufacturing quality standards. Consequently, there is
always a risk that the FDA or other applicable governmental authorities will not approve our
products, or will take post-approval action limiting or revoking our ability to sell our products,
or that the rate, timing and cost of such approvals will adversely affect our product introduction
plans, results of operations and stock price. Despite the time and expense exerted, regulatory
approval is never guaranteed.
Even after we obtain regulatory approval for a product candidate or new indication, we are subject
to extensive regulation, including ongoing compliance with the FDAs cGMP regulations, completion
of post-marketing clinical studies mandated by the FDA, and compliance with regulations relating to
adverse event reporting, labeling, advertising, marketing and promotion. If we or any third party
that we involve in the testing, packing, manufacture, labeling, marketing and distribution of our
products fail to comply with any such regulations, we may be subject to, among other things,
warning letters, product seizures, recalls, fines or other civil penalties, injunctions, suspension
or revocation of approvals, operating restrictions and/or criminal prosecution. The FDA recently
has increased its enforcement activities related to the advertising and promotion of pharmaceutical
and biological products. In particular, the FDA has expressed concern regarding the pharmaceutical
industrys compliance with the agencys regulations governing direct-to-consumer advertising, and
has increased its scrutiny of such promotional materials. The FDA may limit or, with respect to
certain products, terminate our dissemination of direct-to-consumer advertisements in the future,
which could cause sales for those products to decline. Physicians may prescribe pharmaceutical or
biologic products for uses that are not described in a products labeling or differ from those
tested by us and approved by the FDA. While such off-label uses are common and the FDA does not
regulate a physicians choice of treatment, the FDA does restrict a manufacturers communications
on the subject of off-label use. Companies cannot actively promote FDA-approved pharmaceutical or
biologic products for off-label uses, but they may disseminate to physicians articles published in
peer-reviewed journals. To the extent allowed by law, we disseminate peer-reviewed articles on our
products to targeted physicians. If, however, our promotional activities fail to comply with the
FDAs regulations or guidelines, we may be subject to warnings from, or enforcement action by, the
FDA or another enforcement agency.
If we market products in a manner that violates health care fraud and abuse laws, we may be subject
to civil or criminal penalties.
Federal health care program anti-kickback statutes prohibit, among other things, knowingly and
willfully offering, paying, soliciting, or receiving remuneration to induce or in return for
purchasing, leasing, ordering, or arranging for the purchase, lease or order of any health care
item or service reimbursable under Medicare, Medicaid, or other federally financed health care
programs. This statute has been interpreted to apply to arrangements between pharmaceutical
manufacturers on one hand and prescribers, purchasers, and formulary managers on the other.
Although there are a number of statutory exemptions and regulatory safe harbors protecting certain
common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and
practices that involve remuneration intended to induce prescribing, purchases, or recommendations
may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Although we
believe that we are in compliance, our practices may be determined to fail to meet all of the
criteria for safe harbor protection from anti-kickback liability.
50
Allergan, Inc.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
Federal false claims laws prohibit any person from knowingly presenting, or causing to be
presented, a false claim for payment to the federal government, or knowingly making, or causing to
be made, a false statement to get a false claim paid. Pharmaceutical companies have been prosecuted
under these laws for a variety of alleged promotional and marketing activities, such as allegedly
providing free product to customers with the expectation that the customers would bill federal
programs for the product; reporting to pricing services inflated average wholesale prices that were
then used by federal programs to set reimbursement rates; engaging in off-label promotion that
caused claims to be submitted to Medicaid for non-covered off-label uses; and submitting inflated
best price information to the Medicaid Rebate Program. The majority of states also have statutes or
regulations similar to the federal anti-kickback law and false claims laws, which apply to items
and services reimbursed under Medicaid and other state programs, or, in several states, apply
regardless of the payor. Sanctions under these federal and state laws may include civil monetary
penalties, exclusion of a manufacturers products from reimbursement under government programs,
criminal fines, and imprisonment. Because of the breadth of these laws and the narrowness of the
safe harbors, it is possible that some of our business activities could be subject to challenge
under one or more of such laws. For example, we and several other pharmaceutical companies are
currently subject to suits by governmental entities in several jurisdictions, including
Massachusetts, New York and Alabama alleging that we and these other companies, through
promotional, discounting, and pricing practices reported false and inflated average wholesale
prices or wholesale acquisition costs and failed to report best prices as required by federal and
state rebate statutes, resulting in the plaintiffs overpaying for certain medications.
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ALLERGAN, INC.
ITEM 4. Controls and Procedures
CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms, and that such information is accumulated and communicated to our management, including our
Principal Executive Officer and our Principal Financial Officer, as appropriate, to allow timely
decisions regarding required disclosures. Our management, including our Principal Executive Officer
and our Principal Financial Officer, does not expect that our disclosure controls or procedures
will prevent all error and all fraud. A control system, no matter how well conceived and operated,
can provide only reasonable, not absolute, assurance that the objectives of the control system are
met. Further, the benefits of controls must be considered relative to their costs. Because of the
inherent limitations in all control systems, no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any, within Allergan have been
detected. These inherent limitations include the realities that judgments in decision-making can be
faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two or more people, or
by management override of the control. The design of any system of controls is also based in part
upon certain assumptions about the likelihood of future events, and there can be no assurance that
any design will succeed in achieving its stated goals under all potential future conditions.
Because of the inherent limitations in a cost-effective control system, misstatements due to error
or fraud may occur and not be detected. Also, we have investments in certain unconsolidated
entities. As we do not control or manage these entities, our disclosure controls and procedures
with respect to such entities are necessarily substantially more limited than those we maintain
with respect to our consolidated subsidiaries.
We carried out an evaluation, under the supervision and with the participation of our management,
including our Principal Executive Officer and our Principal Financial Officer, of the effectiveness
of the design and operation of our disclosure controls and procedures as of September 30, 2005, the
end of the quarterly period covered by this report. Based on the foregoing, our Principal Executive
Officer and our Principal Financial Officer concluded that our disclosure controls and procedures
were effective at the reasonable assurance level.
There has been no change in the Companys internal controls over financial reporting during the
Companys most recent fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the Companys internal controls over financial reporting.
52
Allergan, Inc.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Litigation
The following supplements and amends the Companys discussion set forth under Part I, Item 3,
Legal Proceedings in the Companys Annual Report on Form 10-K for the year ended December 31,
2004 and Part II, Item 1 in the Companys Quarterly Report on Form 10-Q for the quarter ended June
24, 2005.
On June 6, 2001, after receiving paragraph 4 invalidity and noninfringement Hatch-Waxman Act
certifications from Apotex indicating that Apotex had filed an Abbreviated New Drug Application
with the FDA for a generic form of Acular®, we and Roche Palo Alto, LLC, formerly known as Syntex
(U.S.A.) LLC, the holder of the Acular® patent, filed a lawsuit entitled Syntex (U.S.A.) LLC and
Allergan, Inc. v. Apotex, Inc., et al. in the United States District Court for the Northern
District of California. Following a trial, the court entered final judgment in our favor on January
27, 2004, holding that the patent at issue is valid, enforceable and infringed by Apotexs proposed
generic drug. On February 17, 2004, Apotex filed a Notice of Appeal with the United States Court of
Appeals for the Federal Circuit. On May 18, 2005, the Court of Appeals for the Federal Circuit
issued an opinion affirming the lower courts ruling on inequitable conduct and claim construction
and reversing and remanding the issue of obviousness. The court did not address the issue of
infringement. On August 13, 2005, Apotex filed a motion to
vacate the injunction pending resolution of
the remand from the United States Court of Appeals for the Federal Circuit on the obviousness. On
October 28, 2005, the court denied Apotexs motion. On June 29, 2001, we filed a separate lawsuit
in Canada against Apotex similarly relating to a generic version of Acular®. A mediation in the
Canadian lawsuit was held on January 4, 2005 and a settlement conference previously scheduled for
April 6, 2005 was originally continued to summer 2005. A new date for the summer 2005 status
conference has not been set.
On June 2, 2003, a complaint entitled Klein-Becker usa, LLC v. Allergan, Inc. was filed in the
United States District Court for the District of Utah Central Division. The complaint, as later
amended, contained claims against us for intentional interference with contractual and economic
relations and unfair competition under federal and Utah law. The complaint sought declaratory and
injunctive relief, based on allegations that we interfered with Klein-Beckers contractual and
economic relations by dissuading certain magazines from running Klein-Beckers advertisements for
its anti-wrinkle cream. On July 30, 2003, we filed a reply and counterclaims against Klein-Becker,
asserting, as later amended, claims for false advertising, unfair competition under federal and
Utah law, trade libel, trademark infringement and dilution, and seeking declaratory relief in
connection with Klein-Beckers advertisements for its anti-wrinkle cream that use the heading
Better than BOTOX®? On July 31, 2003, the court denied Klein-Beckers application for a temporary
restraining order to restrain us from, among other things, contacting magazines regarding
Klein-Beckers advertisements. On October 7, 2003, the court granted in part and denied in part our
motion to dismiss Klein-Beckers complaint, dismissing Klein-Beckers claims for unfair competition
under federal and Utah law and its motion for injunctive relief. On August 14, 2004, the court
denied in its entirety Klein-Beckers motion to dismiss our claims. From July 2004 through December
2004, the case was voluntarily stayed while the parties explored settlement through mediation. The
voluntary stay ended December 29, 2004, without the parties reaching settlement. On March 2, 2005,
Klein-Becker filed a motion to amend the scheduling order and a motion for leave to amend the first
amended complaint. On August 4, 2005, Klein-Becker filed a Motion for Partial Summary Judgment. On
August 24, 2005, the court granted Klein-Beckers motion to amend the scheduling order and
Klein-Beckers motion for leave to amend the first amended complaint. On September 16, 2005,
Klein-Becker filed its second amended complaint asserting claims for cancellation of registered
trademark, false advertising and unfair competition, intentional interference with potential and
existing contractual relations, and declaratory relief. On October 7, 2005, we filed our response
to the second amended complaint and a motion to dismiss certain claims in Klein-Beckers second
amended complaint. On October 25, 2005, we filed a
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Allergan, Inc.
Litigation (Continued)
motion for partial summary judgment and a motion for preliminary injunction. The hearing on
Klein-Beckers motion for partial summary judgment is set for December 19, 2005. Trial has been
set for May 8, 2006.
On July 13, 2004, we received a paragraph 4 Hatch-Waxman Act certification from Alcon, Inc.
indicating that Alcon had filed a New Drug Application with the FDA for a drug containing
brimonidine tartrate ophthalmic solution in a 0.15% concentration. In the certification, Alcon
contends that U.S. Patent Nos. 5,424,078; 6,562,873; 6,627,210; 6,641,834; and 6,673,337, all of
which are assigned to us or our wholly-owned subsidiary, Allergan Sales, LLC, and are listed in the
Orange Book under Alphagan® P, are invalid and/or not infringed by the proposed Alcon product. On
August 24, 2004, we filed a complaint, entitled Allergan, Inc., Allergan Sales, LLC v. Alcon,
Inc., Alcon Laboratories, Inc., and Alcon Research, Ltd., against Alcon for patent infringement in
the United States District Court for the District of Delaware. On September 3, 2004, Alcon filed an
answer to the complaint and a counterclaim against us. On September 23, 2004, we filed a reply to
Alcons counterclaim. On May 2, 2005, Alcon filed a Motion for Summary Judgment of Non-Infringement
of U.S. Patent No. 6,673,337 and Invalidity of U.S. Patent No. 6,641,834. The court took the Motion
for Summary Judgment under submission without oral argument. On July 25, 2005, Alcon filed a
motion for leave to amend its answer to the complaint and counterclaim. On July 26, 2005, the
court adopted our proposed claim construction. Trial is scheduled for March 6, 2006. Pursuant to
the Hatch-Waxman Act, approval of Alcons generic New Drug Application is stayed until the earlier
of (1) 30 months from the date of the paragraph 4 certification, or (2) a ruling in the patent
infringement litigation in Alcons favor.
On August 26, 2004, a complaint entitled Clayworth, et al. v. Allergan, Inc., et al. was filed in
the Superior Court of the State of California for the County of Alameda. The complaint, as amended,
names us and 12 other defendants and alleges unfair business practices based upon a price fixing
conspiracy in connection with the reimportation of pharmaceuticals
from Canada. The complaint seeks damages, equitable relief,
attorney's fees and costs. On November 22,
2004, the pharmaceutical defendants jointly filed a demurrer to the first amended complaint. On
February 4, 2005, the court issued an order sustaining the pharmaceutical defendants demurrer and
granting plaintiffs leave to further amend the first amended complaint. On February 22, 2005, the
plaintiffs filed a second amended complaint to which the pharmaceutical defendants filed a
demurrer. A hearing on the demurrer to the second amended complaint took place on April 8, 2005. On
April 19, 2005, the court sustained the pharmaceutical defendants demurrer and granted the
plaintiffs leave to further amend the second amended complaint. On May 6, 2005, the plaintiffs
filed a third amended complaint. On May 27, 2005, the pharmaceutical defendants filed a demurrer.
The hearing on the demurrer to the third amended complaint took place on June 30, 2005. On July 1,
2005, the court overruled in part and sustained without leave to amend in part the pharmaceutical
defendants demurrer, dismissing the portion of plaintiffs third amended complaint alleging that
the pharmaceutical defendants violated Californias Unfair Competition Law by charging plaintiffs
more for pharmaceuticals than they charged others outside of the United States for the same
pharmaceuticals. The court overruled the pharmaceutical defendants demurrer with respect to
plaintiffs claim under the Cartwright Law that the pharmaceutical defendants conspired to maintain
high, non-competitive prices for pharmaceuticals in the United States and sought to restrict the
importation of lower-priced pharmaceuticals into the United States. The pharmaceutical defendants
response to the third amended complaint was filed on July 15, 2005. Trial has been set for July 10,
2006.
On May 24, 2005, after receiving paragraph 4 invalidity and noninfringement Hatch-Waxman Act
certifications from Apotex indicating that Apotex had filed an Abbreviated New Drug Application
with the FDA for a generic form of Acular LS®, we and Roche Palo Alto, LLC, formerly
known as Syntex (U.S.A.) LLC, the holder of the Acular LS® patent, filed a lawsuit
entitled Roche Palo Alto LLC, formerly known as Syntex (U.S.A.) LLC and Allergan, Inc. v. Apotex,
Inc., et al. in the United States District Court for the Northern District of California. In the
complaint, we and Roche asked the court to find that the Acular LS® patent is valid,
enforceable and infringed by Apotexs proposed generic drug. On July 25, 2005, Apotex filed an
answer to the complaint and a counterclaim against us and Roche. On August 26, 2005, we filed our
response to Apotexs counterclaim. On August 30, 2005, the court ordered this case related to the
action entitled Syntex (U.S.A.) LLC and Allergan, Inc. v. Apotex, Inc., et al. noted above.
54
Allergan, Inc.
Litigation (Continued)
We are involved in various other lawsuits and claims arising in the ordinary course of business.
These other matters are, in the opinion of management, immaterial both individually and in the
aggregate with respect to our consolidated financial position, liquidity or results of operations.
Because of the uncertainties related to the incurrence, amount and range of loss on any pending
litigation, investigation or claim, management is currently unable to predict the ultimate outcome
of any litigation, investigation or claim, determine whether a liability has been incurred or make
an estimate of the reasonably possible liability that could result from an unfavorable outcome. We
believe, however, that the liability, if any, resulting from the aggregate amount of uninsured
damages for any outstanding litigation, investigation or claim will not have a material adverse
effect on our consolidated financial position, liquidity or results of operations. However, an
adverse ruling in a patent infringement lawsuit involving us could materially affect our ability to
sell one or more of our products or could result in additional competition. In view of the
unpredictable nature of such matters, we cannot provide any assurances regarding the outcome of any
litigation, investigation or claim to which we are a party or the impact on us of an adverse ruling
in such matters.
55
Allergan, Inc.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Issuer Purchases of Equity Securities
The following table discloses the purchases of our equity securities during the third fiscal
quarter of 2005.
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|
|
|
|
|
|
Total Number of |
|
(or Approximate Dollar |
|
|
|
|
|
|
|
|
|
|
Shares Purchased as |
|
Value) of Shares that May |
|
|
Total Number |
|
|
|
|
|
Part of Publicly |
|
Yet Be Purchased |
|
|
of Shares |
|
Average Price Paid |
|
Announced Plans |
|
Under the Plans |
Period |
|
Purchased(1) |
|
per Share |
|
or Programs |
|
or Programs(2) |
June 25, 2005
to July 31, 2005 |
|
|
0 |
|
|
$ |
N/A |
|
|
|
|
|
|
|
5,932,076 |
|
August 1, 2005 to
August 31, 2005 |
|
|
0 |
|
|
$ |
N/A |
|
|
|
|
|
|
|
6,460,744 |
|
September 1, 2005
to September 30,
2005 |
|
|
0 |
|
|
$ |
N/A |
|
|
|
|
|
|
|
6,538,084 |
|
Total |
|
|
0 |
|
|
$ |
N/A |
|
|
|
|
|
|
|
N/A |
|
|
|
|
(1) |
|
We maintain an evergreen stock repurchase program, which was first announced on September 28,
1993. Under the stock repurchase program, we may maintain up to 9.2 million repurchased shares
in our treasury account at any one time. As of September 30, 2005, we held approximately 2.7
million treasury shares under this program. |
|
(2) |
|
The following share numbers reflect the maximum number of shares that may be purchased under
our stock repurchase program and are as of the end of each of the respective periods. |
Item 5. Other Information.
None.
56
Allergan, Inc.
Item 6. Exhibits
Exhibits (numbered in accordance with Item 601 of Regulation S-K)
|
|
|
|
|
|
|
|
|
4.11 |
|
Third
Amendment to Rights Agreement dated as of October 19, 2005
between Allergan, Inc. and Wells Fargo Bank, National Association, as
successor Rights Agent |
|
|
|
|
|
10.51* |
|
Botox® China License Agreement, dated as of September 30, 2005, by
and among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited |
|
|
|
|
|
10.52* |
|
Botox® Japan License Agreement, dated as of September 30, 2005, by
and among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited |
|
|
|
|
|
10.53* |
|
Co-Promotion Agreement, dated as of September 30, 2005, Allergan,
Inc., Allergan Sales, LLC and SmithKline Beecham Corporation d/b/a
GlaxoSmithKline |
|
|
|
|
|
10.54* |
|
Botox® Global Strategic Support Agreement, dated as of September 30,
2005, by and among Allergan, Inc., Allergan Sales, LLC and Glaxo
Group Limited |
|
|
|
|
|
10.55* |
|
China Botox® Supply Agreement, dated as of September 30, 2005, by and
among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited |
|
|
|
|
|
10.56* |
|
Japan Botox® Supply Agreement, dated as of September 30, 2005, by and
between Allergan Pharmaceuticals Ireland and Glaxo Group Limited |
|
|
|
|
|
10.57 |
|
Transfer
Agent Services Agreement dated as of October 7, 2005, by and
between Allergan, Inc. and Wells Fargo Bank, National Association |
|
|
|
|
|
31.1 |
|
Certification of Principal Executive Officer Required Under Rule
13a-14(a) of the Securities Exchange Act of 1934, as amended |
|
|
|
|
|
31.2 |
|
Certification of Principal Financial Officer Required Under Rule
13a-14(a) of the Securities Exchange Act of 1934, as amended |
|
|
|
|
|
32 |
|
Certification of Principal Executive Officer and Principal Financial
Officer Required Under Rule 13a-14(b) of the Securities Exchange Act
of 1934, as amended, and 18 U.S.C. Section 1350 |
* Confidential
treatment has been requested with respect to the omitted portions of
this Exhibit, which portions have been filed separately with the
Securities and Exchange Commission.
57
SIGNATURE
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: November 7, 2005 |
ALLERGAN, INC.
|
|
|
/s/ Jeffrey L. Edwards
|
|
|
Jeffrey L. Edwards |
|
|
Executive Vice President, Finance and Business
Development, Chief Financial Officer
(Principal Financial Officer) |
|
|
58
INDEX TO EXHIBITS
|
|
|
|
|
4.11 |
|
Third
Amendment to Rights Agreement dated as of October 19, 2005
between Allergan, Inc. and Wells Fargo Bank, National Association, as
successor Rights Agent |
|
|
|
|
|
10.51* |
|
Botox® China License Agreement, dated as of September 30, 2005, by
and among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited |
|
|
|
|
|
10.52* |
|
Botox® Japan License Agreement, dated as of September 30, 2005, by
and among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited |
|
|
|
|
|
10.53* |
|
Co-Promotion Agreement, dated as of September 30, 2005, Allergan,
Inc., Allergan Sales, LLC and SmithKline Beecham Corporation d/b/a
GlaxoSmithKline |
|
|
|
|
|
10.54* |
|
Botox® Global Strategic Support Agreement, dated as of September 30,
2005, by and among Allergan, Inc., Allergan Sales, LLC and Glaxo
Group Limited |
|
|
|
|
|
10.55* |
|
China Botox® Supply Agreement, dated as of September 30, 2005, by and
among Allergan, Inc., Allergan Sales, LLC and Glaxo Group Limited |
|
|
|
|
|
10.56* |
|
Japan Botox® Supply Agreement, dated as of September 30, 2005, by and
between Allergan Pharmaceuticals Ireland and Glaxo Group Limited |
|
|
|
|
|
10.57 |
|
Transfer
Agent Services Agreement dated as of October 7, 2005, by and
between Allergan, Inc. and Wells Fargo Bank, National Association |
|
|
|
|
|
31.1 |
|
Certification of Principal Executive Officer Required Under Rule
13a-14(a) of the Securities Exchange Act of 1934, as amended |
|
|
|
|
|
31.2 |
|
Certification of Principal Financial Officer Required Under Rule
13a-14(a) of the Securities Exchange Act of 1934, as amended |
|
|
|
|
|
32 |
|
Certification of Principal Executive Officer and Principal Financial
Officer Required Under Rule 13a-14(b) of the Securities Exchange Act
of 1934, as amended, and 18 U.S.C. Section 1350 |
* Confidential
treatment has been requested with respect to the omitted portions of
this Exhibit, which portions have been filed separately with the
Securities and Exchange Commission.