UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
| R |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended March 25, 2005
OR
| £ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
COMMISSION FILE NUMBER 1-10269
ALLERGAN,
INC.
|
DELAWARE
(State or Other Jurisdiction of Incorporation or Organization) |
95-1622442
(I.R.S. Employer Identification No.) |
|
2525 DUPONT DRIVE, IRVINE, CALIFORNIA
(Address of Principal Executive Offices) |
92612
(Zip Code) |
(714) 246-4500
(Registrants Telephone Number,
Including Area Code)
Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes R No £
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes R No £
As of April 20, 2005 there were 134,254,772 shares of common stock outstanding (including 3,822,742 shares held in treasury).
ALLERGAN, INC.
FORM 10-Q FOR THE QUARTER ENDED MARCH 25, 2005
INDEX
2
PART I FINANCIAL INFORMATION
Allergan, Inc.
Unaudited Condensed Consolidated Statements of Earnings
See accompanying notes to unaudited condensed consolidated financial statements.
3
(in millions, except per share amounts)
Three months ended
March 25,
March 26,
2005
2004
$
527.2
$
472.4
94.1
87.6
433.1
384.8
210.3
180.6
82.0
86.1
27.4
113.4
118.1
5.5
2.0
(4.5
)
(3.7
)
0.1
(0.1
)
4.5
(0.1
)
5.6
(1.9
)
119.0
116.2
39.2
35.1
(0.1
)
0.3
$
79.9
$
80.8
$
0.61
$
0.62
$
0.60
$
0.60
Allergan, Inc.
Unaudited Condensed Consolidated Balance Sheets
See accompanying notes to unaudited condensed consolidated financial statements.
4
Allergan, Inc.
Unaudited Condensed
Consolidated Statements of Cash Flows
See accompanying notes to unaudited condensed consolidated financial statements.
5
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
1. In the opinion of management, the accompanying unaudited condensed consolidated financial
statements contain all adjustments necessary (consisting only of normal recurring accruals) to
present fairly the financial information contained therein. These statements do not include all
disclosures required by accounting principles generally accepted in the United States of America
(GAAP) for annual periods and should be read in conjunction with the Companys audited consolidated
financial statements and related notes for the year ended December 31, 2004. The Company prepared
the condensed consolidated financial statements following the requirements of the Securities and
Exchange Commission for interim reporting. As permitted under those rules, certain footnotes or
other financial information that are normally required by GAAP can be condensed or omitted. The
results of operations for the three months ended March 25, 2005 are not necessarily indicative of
the results to be expected for the year ending December 31, 2005 or any other period(s).
Reclassifications
Certain reclassifications of prior year amounts have been made to conform with the current year
presentation.
Stock-Based Compensation
As allowed by Statement of Financial Accounting Standards No. 123,
Accounting for Stock-Based
Compensation
, the Company has elected to continue to apply the intrinsic-value-based method of
accounting. Under this method, the Company measures stock-based compensation for option grants to
employees assuming that options granted at market price at the date of grant have no intrinsic
value. The Companys contributions of common stock related to the Companys savings and investment
plans are measured at market price at the date of contribution. Restricted stock awards, including
restricted stock units, are valued based on the market price of a share of nonrestricted stock on
the grant date. No compensation expense has been recognized for stock-based incentive compensation
plans other than for the contributions of common stock to the Companys savings and investment
plans and the restricted stock awards under both the incentive compensation plan and the
non-employee director equity incentive plan. Had compensation expense for the Companys stock
options under the incentive compensation plan and the non-employee director equity incentive plan
been recognized based upon the fair value of awards granted, the Companys net earnings would have
been reduced to the following
pro forma
amounts:
6
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
These
pro forma
effects are not indicative of future amounts. The Company expects to grant
additional awards in future years. (See New Accounting Standards Not Yet Adopted in Note 2 below
for a discussion of Statement of Financial Accounting Standards No. 123 (revised 2004),
Share-Based
Payment
).
2. Recently Adopted Accounting Standards
In December 2004, Financial Accounting Standards Board Position 109-2 (FASB Staff Position
109-2) was issued and is 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 currently has no plans to change its
policy regarding indefinite reinvestment of unremitted earnings in the Companys foreign
operations. However, the Company is evaluating the Acts provisions relating to incentives to
reinvest foreign earnings in the United States, which require a domestic reinvestment plan to be
created and approved by the Companys board of directors before executing any repatriation
activities. At this time, the Company has not completed its evaluation. The Company expects to
complete its evaluation by the end of the Companys third fiscal quarter of 2005. The range of
reasonably possible amounts of unremitted foreign earnings that may be considered for repatriation
under the provisions of the Act is currently between zero and $674 million. The
7
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
related range of estimated income tax effects on such repatriation is currently between zero and
$60 million.
In October 2004, the FASB ratified the consensuses 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, or FASB Staff Position
109-1, was issued and is 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 United States 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- 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
8
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
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 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. 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 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. The restructuring steps to be implemented and their ultimate cost will depend
in part on the outcome of such consultations and negotiations.
The Company anticipates incurring 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
9
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
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 $3 million to $4 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 second 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, began to be recorded in the
first quarter of 2005 and 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, began to be
recorded in the first quarter of 2005 and 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 the Companys High Wycombe, U.K. facility or a new facility in the U.K. to
accommodate increased headcount). These capital expenditures are currently estimated to be between
approximately $5 million and $7 million, and are currently expected to be recorded beginning in the
second quarter of 2005 and continuing up through and including the first quarter of 2006.
During the first quarter of 2005, the Company recorded pre-tax restructuring charges of $20.7
million related to the restructuring of
the Companys European operations. The restructuring charges primarily consist of employee
severance, employee relocation and other costs. The following
10
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
table presents the cumulative restructuring activities through March 25, 2005:
Employee severance in the preceding table relates to 153 employees, of which five were severed as
of March 25, 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 quarter of 2005, the Company also recorded $0.3 million of transition/duplicate operating
expenses associated with the European restructuring activities. Transition/duplicate operating expenses consisted primarily of salaries, travel, communications and
consulting costs. Transition/duplicate operating expenses have been included in the normal
operating expense classifications to which they relate on the unaudited condensed consolidated
statements of earnings.
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 of the Companys manufacturing and supply agreement with Advanced
Medical Optics, Inc. (AMO) a former subsidiary that was spun-off from the Company in June 2002.
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 plans to eliminate 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 $24 million and $28 million. The Company began recording these charges in the fourth
quarter of 2004 and expects to continue recording them up through and including the fourth quarter
of 2005. The pre-tax charges are net of expected tax credits available under qualifying
government-sponsored employment programs. Approximately $24 million of the restructuring charges
are expected to be cash charges. The restructuring charges are expected to include approximately
$20 million to $22 million associated with the reduction in the Companys workforce of
approximately 350 individuals. The workforce reduction will impact personnel in Europe, the United
States and Latin America. The workforce reduction began in the fourth quarter of 2004 and is
expected to be completed by the end of the second quarter of 2005.
11
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
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 March 25, 2005, the Company recorded cumulative pre-tax restructuring charges of $13.8
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.
The following table presents the cumulative restructuring activities through March 25, 2005
resulting from the scheduled termination of the manufacturing and supply agreement in June 2005:
The remaining balance at March 25, 2005 is comprised of accrued statutory severance and one-time
termination benefits of $15.5 million, less expected employment program tax credits of $3.0
million.
4. Intangibles and Goodwill
At March 25, 2005 and December 31, 2004, the components of amortizable and unamortizable
intangibles and goodwill and certain other related information were as follows:
12
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
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 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 $2.0 million for each of the
quarters ended March 25, 2005 and March 26, 2004.
Estimated amortization expense is $8.2 million for 2005, $7.9 million for 2006, $6.8 million for
Goodwill
There was no activity related to goodwill during the quarter ended March 25, 2005. The changes in
goodwill balances are the result of foreign currency translation.
5. Inventories
Components of inventories were:
6. Income Taxes
Income taxes are determined using an estimated annual effective tax rate, which is generally
less than the U.S. Federal statutory rate,
13
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
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 $51.9 million at both March 25,
2005 and December 31, 2004. 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.
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
permanently in such operations. At December 31, 2004, the Company had approximately $1,011 million
in unremitted earnings outside the United States for which withholding and U.S. taxes were not
provided. Tax expense would be incurred if these funds were remitted to the United States. It is
not practicable to estimate the amount of the deferred tax liability on the total amount of such
unremitted earnings. Upon remittance, certain foreign countries impose withholding taxes that are
then available, subject to certain limitations, for use as credits against the Companys U.S. tax
liability, if any. The Company annually updates its estimate of unremitted earnings outside the
United States after the completion of each fiscal year.
On October 22, 2004, the American Jobs Creation Act of 2004 (the Act) was enacted in the United
States. The Company is currently evaluating the impact of the Act on its operations and effective
tax rate. In particular, the Company is evaluating the Acts provisions relating to incentives to
reinvest foreign earnings in the United States, which require a domestic reinvestment plan to be
created and approved by the Companys board of directors before executing any repatriation
activities. At this time, the Company has not completed its evaluation. The Company expects to
complete its evaluation by the end of the Companys third fiscal quarter of 2005. The range of
reasonably possible amounts of unremitted foreign earnings that may be considered for repatriation
under the provisions of the Act is currently between zero and $674 million. The related range of
estimated income tax effects on such repatriation is currently between zero and $60 million.
14
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
7. 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 month periods ended March 25, 2005 and March
26, 2004, respectively, were as follows:
In 2005, the Company currently expects to pay contributions of between $14.3 million and $16.3
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.
8. Litigation
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 Standard 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 Syntex, 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
15
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Court of Appeals for the Federal Circuit. Oral argument on the appeal took place on November 1,
2004 and the Company is currently awaiting the Court of Appeals ruling. If the Court of Appeals
reverses the prior judgment in the Companys favor,
Acular
® could face immediate generic
competition. 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 has been
continued to summer 2005.
On January 23, 2003, a complaint entitled Irena Medavoy and Morris Mike Medavoy v. Arnold W.
Klein, M.D., et al. and Allergan, Inc. was filed in the Superior Court of the State of California
for the County of Los Angeles. The complaint contained, among other things, allegations against the
Company of negligence, unfair business practices, product liability, intentional misconduct, fraud,
negligent misrepresentation, strict liability in tort, improper off-label promotion and loss of
consortium. The complaint also contained separate allegations against the other defendants. On
April 10, 2003, Morris Mike Medavoy voluntarily served on the Company a Request for Dismissal
Without Prejudice for the only two causes of action he asserted in the complaint. The causes of
action asserted by Irena Medavoy against us were not affected by this Request for Dismissal. On
July 8, 2003, Irena Medavoy filed a First Amended Complaint, adding allegations against the Company
of false and/or misleading advertising and unjust enrichment, as well as false and/or misleading
advertising and unfair competition. A jury trial in the matter began on August 31, 2004. On October
8, 2004, the jury ruled in favor of the Company and Dr. Klein. Also on October 8, 2004, the court
dismissed the unfair business practices claims against the Company and Dr. Klein. On November 29,
2004, Irena Medavoy filed a Motion for New Trial. On December 16, 2004, the court denied Irena
Medavoys Motion for a New Trial. On January 13, 2005, Irena Medavoy filed a Notice of Appeal with
the Clerk of Court of the Superior Court of the State of California for the County of Los Angeles
and her opening appellate brief is due on May 31, 2005.
On June 2, 2003, a complaint entitled Klein-Becker usa, LLC v. Allergan, Inc. was filed in the
United Stated District Court for the District of Utah Central Division. The complaint, as later
amended, contained claims against the Company for declaratory relief, intentional interference with
contractual and economic relations, unfair competition under federal and Utah law, 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, declaratory relief, and trademark infringement and dilution, and
alleging that Klein-Beckers advertisements for its anti-wrinkle cream that use the heading Better
than BOTOX®? are false and misleading. On July 31, 2003, the court denied Klein-Beckers
application for a temporary restraining order to restrain the Company from, among other things,
16
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
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 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. The court has not set a hearing
date for either motion. Trial is scheduled for August 1, 2005.
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 under section 505(b)(2) of the Federal
Food, Drug, and Cosmetic Act 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. A claim construction hearing is scheduled for June 7, 2005. 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, which names
the Company and 12 other defendants, alleges unfair business practices based upon a price fixing
conspiracy in connection with the reimportation of pharmaceuticals from Canada. On September 3,
2004, the plaintiffs filed a first amended complaint, making various modifications to the original
complaint. 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 defendants again filed a demurrer. The hearing on the demurrer to the second amended complaint
was held on April 8, 2005 and the court took the matter under submission.
17
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
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.
9. Guarantees
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 insurance policies intended
to
18
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
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.
19
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
10. Earnings Per Share
The table below presents the computation of basic and diluted earnings per share:
For the three month period ended March 25, 2005, options to purchase 5.4 million shares of
common stock at exercise prices ranging from $76.15 to $127.51 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 and, therefore, the effect would be
anti-dilutive. For the three month period ended March 26, 2004, options to purchase 2.0 million
shares of common stock at exercise prices ranging from $88.55 to $127.51 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 and, therefore, the effect would be
anti-dilutive.
20
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
11. Comprehensive Income
The following table summarizes components of comprehensive income for the three month periods
ended March 25, 2005, and March 26, 2004:
12. Business Segment Information
The Company 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 Companys principal markets are the United States, Europe, Latin America and Asia
Pacific. The United States information is presented separately as it is the Companys headquarters
country, and U.S. sales, including manufacturing operations, represented 66.9% and 70.5% of the
Companys total consolidated product net sales for the quarters ended March 25, 2005 and March 26,
2004, respectively.
Sales to McKesson Drug Company for the three month periods ended March 25, 2005 and March 26, 2004
were 14.4% and 14.0%, respectively, of the Companys total consolidated product net sales. Sales
to Cardinal Healthcare for the three month periods ended March 25, 2005 and March 26,
21
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
2004 were 13.4% and 16.7%, respectively, of the Companys total consolidated product net sales. 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. 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.
Long-lived assets are assigned to geographic regions based upon management responsibility for such
items.
Geographic Information
22
Allergan, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
13. 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 tax
in one or more states, the imposition and collection of sales or other tax on
Botox
® or
Botox
®
Cosmetic could result in a substantial tax liability, and potential penalties and interest, for
prior taxable periods. The imposition and collection of sales or other 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 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 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.
14. Subsequent Event
Effective April 19, 2005, the Company entered into a royalty buy-out agreement with Novartis
Pharmaceuticals Corporation and Novartis Pharma AG (collectively, Novartis). Under the royalty
buy-out agreement, Novartis will assign to the Company all of its rights and obligations worldwide,
excluding Japan, associated with an exclusive license agreement between Novartis and the University
of Georgia Research Foundation for technology, patents and products relating to the topical
ophthalmic use of cyclosporine A. Cyclosporine A is the active ingredient in
Restasis
®, the
Companys drug for the treatment of chronic dry eye disease. The Company and Novartis also agreed
to terminate their exclusive sublicense agreement related to the same technology, patents and
products such that the Company will no longer be required to make royalty payments to Novartis in
connection with the Companys sales of
Restasis
®. In full consideration of the assignment and
termination, the Company agreed to pay to Novartis $110.0 million.
23
ALLERGAN, INC.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005
This financial review presents our operating results for the three month periods ended March 25,
2005 and March 26, 2004, and our financial condition at March 25, 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 month period ended March 25, 2005.
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 between one to two months 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 March 25, 2005 and December 31, 2004 were $1.6 million and $1.3
million, respectively. Provisions for cash discounts deducted from consolidated sales in the first
quarter of 2005 and first quarter of 2004 were $5.9 million and $5.5 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. The
amount of allowances for sales returns reserved at March 25, 2005 and December 31, 2004 were $5.1
million and $5.8 million, respectively. Provisions for sales returns deducted from consolidated
sales were $5.0 million and $6.7 million in the first quarter of 2005 and first quarter of 2004,
respectively. Historical allowances for cash discounts and product returns have been within the
amounts reserved or accrued, respectively.
24
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
CRITICAL ACCOUNTING POLICIES (Continued)
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 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 balance sheets. The amounts accrued for sales rebates and other incentive
programs at March 25, 2005 and December 31, 2004 were $72.8 million and $61.4 million,
respectively. The $11.4 million increase in the amount accrued for sales rebates and other
incentive programs is primarily due to a difference in the timing of when payments were made
against accrued amounts at March 25, 2005 compared to December 31, 2004 and an increase in the
ratio of U.S. pharmaceutical product sales, principally eye care pharmaceutical products, subject
to such rebates and incentive programs. Provisions for sales rebates and other incentive programs
deducted from consolidated sales were $46.2 million and $38.2 million in the first quarter of 2005
and first quarter of 2004, respectively. 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 $2 million to $3 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.
25
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
CRITICAL ACCOUNTING POLICIES (Continued)
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 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.
26
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
CRITICAL ACCOUNTING POLICIES (Continued)
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 $51.9 million at both March 25, 2005 and
December 31, 2004. 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 permanently
in such operations. At December 31, 2004, we had approximately $1,011 million in unremitted
earnings outside the United States for which withholding and U.S. taxes were not provided. Tax
expense would be incurred if these funds were remitted to the United States. It is not practicable
to estimate the amount of the deferred tax liability on the total amount of such unremitted
earnings. Upon remittance, certain foreign countries impose withholding taxes that are then
available, subject to certain limitations, for use as credits against our U.S. tax liability, if
any. We annually update our estimate of unremitted earnings outside the United States after the
completion of each fiscal year.
On October 22, 2004, the American Jobs Creation Act of 2004, or the Act, was enacted in the United
States. We are currently evaluating the impact of the Act on our operations and effective tax
rate. In particular, we are evaluating the Acts provisions relating to incentives to reinvest
foreign
27
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
CRITICAL ACCOUNTING POLICIES (Continued)
earnings in the United States, which require a domestic reinvestment plan to be created and
approved by our board of directors before executing any repatriation activities. At this time, we
have not completed our evaluation. We expect to complete our evaluation by the end of our third
fiscal quarter of 2005. The range of reasonably possible amounts of unremitted foreign earnings
that may be considered for repatriation under the provisions of the Act is currently between zero
and $674 million. The related range of estimated income tax effects on such repatriation is
currently between zero and $60 million.
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 employ approximately 5,100 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 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-
28
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
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.
The following table compares 2005 and 2004 net sales by product line and certain selected products
for the three month periods ended March 25, 2005 and March 26, 2004:
* 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 is scheduled to
terminate in June 2005.
The $6.7 million increase in net sales from the impact of foreign currency changes for the
three month period ended March 25, 2005 was due primarily to the strengthening of the euro,
Canadian dollar and Brazilian real compared to the U.S. dollar.
The $54.8 million increase in net sales in the first quarter of 2005 compared to the first 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 first quarter of 2005 compared to the first quarter of
2004 primarily because of strong growth in sales 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 eye
drop products, primarily
Refresh
®, an increase in sales of
Zymar
®, a newer anti-infective, an
increase in sales of
Elestat
, our topical antihistamine
29
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
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, and
Acular
®, our
older generation anti-inflammatory. Our
Alphagan
® franchise sales also decreased in the first
quarter of 2005 compared to the first quarter of 2004 due to a general decline in U.S. wholesaler
demand for
Alphagan
®
P
and the negative impact from generic
Alphagan
® competition. 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 between one to
two months of our net sales. At March 25, 2005, based on available external and internal
information, we believe the amount of average U.S. wholesaler inventories of our products was below
our stated policy levels. We currently expect the wholesaler inventory levels of our products to
return to our normal policy levels during the next six months of 2005, which may create above
average U.S. wholesaler demand for our products during our second and third fiscal quarters of 2005
compared to demand experienced during the same periods in 2004.
Botox
® sales increased in the first quarter of 2005 compared to the first quarter of 2004 primarily
as a result of strong growth in demand in international markets and in the United States 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, the U.K., Spain and Italy, as well as an increase
in sales of
Botox
® in smaller distribution markets serviced by our European export sales group. We
believe our worldwide market share for neuromodulators, including
Botox
®, is currently over 85%.
30
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
Skin care sales increased in the first quarter of 2005 compared to the first quarter of 2004
primarily due to higher sales of
Tazorac
®,
Zorac
®,
Avage
® and new product sales generated from
Prevage
antioxidant cream, which we launched in January 2005. Net sales of
Tazorac
®,
Zorac
® and
Avage
® increased $1.8 million, or 9.9%, to $19.8 million in the first quarter of 2005 compared to
$18.0 million in the first quarter of 2004. We increased the published U.S. list price for
Tazorac
® by nine percent effective February 5, 2005.
The decrease in the percentage of U.S. sales as a percentage of total product net sales during the
first three months of 2005 compared to the same period in 2004 was primarily attributable to an
increase in international eye care pharmaceuticals and
Botox
® sales, principally in Europe and
Latin America, as a percentage of total product net sales.
Our gross margin percentage for the first quarter of 2005 was 82.2% of net sales, which represents
a 0.7 percentage point increase from our gross margin percentage of 81.5% for the first quarter of
2004. Our gross margin percentage increased in the first quarter of 2005 compared to the first
quarter of 2004 primarily as a result of an increase in gross margin percentage for the
Botox
®
product line and contract manufacturing sales to AMO, partially offset by a decrease in gross
margin percentage for eye care pharmaceuticals. Our gross margin percentage also increased due to
an increase in the mix of
Botox
® sales, which generally have a higher gross margin percentage than
our other pharmaceutical product lines. The gross margin percentage for eye care pharmaceuticals
declined in the first quarter of 2005 compared to the first quarter of 2004 due to an increase in
the mix of international sales, which generally have a lower gross margin percentage than U.S.
sales, an increase in sales from products with higher royalty rates payable to third parties and a
higher ratio of U.S. sales subject to rebates and other incentive programs. The gross margin
percentage for our
Botox
® product line experienced an increase in the first quarter of 2005
compared to the first quarter of 2004 due primarily to a price increase 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. sales. The gross margin percentage
for contract manufacturing sales improved primarily due to an increase in U.S. dollar denominated
pricing allowed under the manufacturing and supply agreement with AMO at the beginning of our 2005
fiscal year. Gross margin in dollars increased in the first quarter of 2005 compared to the first
quarter of 2004 by $48.3 million, or 12.6%, as a result of the 11.6% increase in net sales and by
the 0.7 percentage point increase in gross margin percentage.
Selling, general and administrative, or SG&A, expenses were $210.3 million, or 39.9% of net sales,
in the first quarter of 2005 compared to $180.6 million, or 38.2% of net sales, in the first
quarter of 2004. The increase in SG&A expense dollars in the first quarter of 2005 compared to the
first
31
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
quarter of 2004 was primarily a result of an increase in promotion costs associated with
direct-to-consumer advertising in the United States for
Botox
® Cosmetic and
Restasis
®, and an
increase in selling expenses, principally personnel costs, and marketing expenses supporting the
increase in consolidated sales, especially for
Restasis
®,
Lumigan
®,
Botox
® and
Botox
® Cosmetic.
SG&A expenses also increased due to an increase in co-promotion costs related to sales of
Elestat
®,
higher general and administrative expenses, principally headcount related costs and consulting
fees, and the non-recurrence of a favorable settlement of a patent dispute amounting to $2.4
million in the first quarter of 2004. 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. As a percentage of net sales, SG&A expenses increased in the first quarter of
2005 compared to the first quarter of 2004, due primarily to higher promotion and marketing
expenses as a percentage of net sales and lower miscellaneous royalty income earned in the first
quarter of 2005 compared to the first quarter of 2004, partially offset by lower selling and
general and administrative expenses as a percentage of net sales.
Research and development expenses were $82.0 million, or 15.6% of net sales, in the first quarter
of 2005 compared to $86.1 million, or 18.2% of net sales, in the first quarter of 2004. Research
and development spending decreased $4.1 million in the first quarter of 2005 compared to the first
quarter of 2004 primarily as a result of lower rates of investment in our skin care and
Botox
®
product lines, partially offset by an increase in spending for eye care pharmaceuticals. Our
expected spending for research and development activities in the first quarter of 2005 was also
negatively impacted by the timing of patient enrollments in clinical trials. We expect research and
development expenses to increase in fiscal year 2005 compared to 2004 as we continue to increase
our investments in eye care pharmaceuticals and increase spending for our
Botox
® product lines and
new technologies during the remainder of 2005.
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 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, U.K. and Dublin, Ireland facilities and streamlining functions in our
European management services group.
32
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
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. The restructuring steps to be implemented and their ultimate cost will depend
in part on the outcome of such consultations and negotiations.
We anticipate incurring 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 $3
million to $4 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 second 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, began to be recorded in the
33
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
first quarter of 2005 and 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, began to be recorded in
the first quarter of 2005 and 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
our High Wycombe, U.K. facility or a new facility in the U.K. to accommodate increased headcount).
These capital expenditures are currently estimated to be between approximately $5 million and $7
million, and are currently expected to be recorded beginning in the second quarter of 2005 and
continuing up through and including the first quarter of 2006.
During the first quarter of 2005, we recorded pre-tax restructuring charges of $20.7 million and
transition/duplicate operating expenses of $0.3 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 March 25, 2005:
Employee severance in the preceding table relates to 153 employees, of which five were severed as
of March 25, 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.
Transition/duplicate operating expenses consisted primarily of salaries, travel, communications and
consulting costs. Transition/duplicate operating expenses have been included in the normal
operating expense classifications to which they relate on the unaudited condensed consolidated
statements of earnings.
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 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
34
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
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 plan to eliminate 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 $24
million and $28 million. We began recording these charges in the fourth quarter of 2004 and expect
to continue recording them up through and including the fourth quarter of 2005. The pre-tax charges
are net of expected tax credits available under qualifying government-sponsored employment
programs. Approximately $24 million of the restructuring charges are expected to be cash charges.
The restructuring charges are expected to include approximately $20 million to $22 million
associated with the reduction in our workforce of approximately 350 individuals. The workforce
reduction will impact personnel in Europe, the United States and Latin America. The workforce
reduction began in the fourth quarter of 2004 and is expected to be completed by the end of the
second quarter of 2005. 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 March 25, 2005, we recorded cumulative pre-tax restructuring charges of $13.8 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.
The following table presents the cumulative restructuring activities through March 25, 2005
resulting from the scheduled termination of the manufacturing and supply agreement in June 2005:
35
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
The remaining balance at March 25, 2005 is comprised of accrued statutory severance and one-time
termination benefits of $15.5 million, less expected employment program tax credits of $3.0
million.
Operating income in the first quarter of 2005 was $113.4 million compared to operating income of
$118.1 million for the first quarter of 2004. The $4.7 million decrease in operating income was
due primarily to the $27.4 million restructuring charge and increase in SG&A expenses of $29.7
million, partially offset by the $48.3 million increase in gross margin and $4.1 million decrease
in research and development expenses.
Total net non-operating income in the first quarter of 2005 was $5.6 million compared to net
non-operating expenses of $1.9 million in the first quarter of 2004. Interest income in the first
quarter of 2005 was $5.5 million compared to interest income of $2.0 million in the first quarter
of 2004. This increase in interest income in the first quarter of 2005 was primarily due to higher
average cash equivalent balances earning interest of approximately $354 million and an increase in
average interest rates earned on all cash equivalent balances earning interest of approximately
1.18% in the first quarter of 2005 compared to the same period in 2004. Interest expense increased
$0.8 million to $4.5 million in the first quarter of 2005 compared to $3.7 million in the first
quarter of 2004, primarily due to an increase in the amortization of deferred debt issuance costs
related to our outstanding zero coupon convertible senior notes due 2022, or Senior Notes, and
higher other statutory interest expense. 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 Senior Notes over the five year period from date of issuance in November 2002 to the
first note holder put date in November 2007 instead of over the 20 year life of the Senior Notes.
We recorded a net unrealized gain on derivative instruments of $0.1 million in the first quarter of
2005 compared to a net unrealized loss of $0.1 million in the first 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. Other, net income was $4.5 million in the first
quarter of 2005 compared to net expenses of $0.1 million in the first quarter of 2004. In the
first quarter 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 gains from foreign currency
transactions of $0.3 million. Other, net in the first quarter of 2004 includes net realized losses
from foreign currency transactions of $1.0 million and a gain of $0.8 million realized from the
settlement of a non-income tax dispute with AMO.
36
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
Our effective tax rate for the first quarter of 2005 was 32.9% compared to the effective tax rate
of 30.2% for the first quarter of 2004, 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. Included in our operating
income in the first quarter of 2005 are pre-tax restructuring charges of $27.4 million associated
with the scheduled termination of our manufacturing and supply agreement with AMO and the
restructuring of our European operations. We recorded an income tax benefit of $2.9 million
related to these pre-tax restructuring charges. Excluding the impact of the $27.4 million pre-tax
restructuring charges and related tax benefit of $2.9 million, our adjusted effective tax rate for
the first quarter of 2005 was 28.8%. The decrease in our adjusted effective tax rate in the first
quarter of 2005 compared to our full year 2004 adjusted effective tax rate is primarily due to a
reduction in the estimated amount of repatriation of current year foreign earnings and a tax rate
benefit from expected changes in the mix of our earnings included in our estimated annual effective
tax rate for fiscal year 2005 compared to 2004. Included in the provision for income taxes in the first quarter
of 2005 is an additional amount for state income taxes paid related to the California income tax amnesty program.
Net earnings in the first quarter of 2005 were $79.9 million compared to net earnings of $80.8
million for the same period last year. The $0.9 million decrease in earnings in the first quarter
of 2005 compared to the first quarter of 2004 was primarily the result of the decrease in operating
income of $4.7 million and the increase in the provision for income taxes of $4.1 million,
partially offset by the increase in total net non-operating income of $7.5 million.
Acceleration of Vesting of Premium Priced Stock Options
The Financial Accounting Standards Board recently published Statement of Financial Accounting
Standards No. 123 (revised 2004), Share-Based Payment (FAS 123R). FAS 123R, which is effective
for us beginning January 1, 2006, will require us to recognize in our financial statements the
grant-date fair value of stock options and other equity-based compensation issued to employees.
Currently, we account for our stock-based compensation using the intrinsic-value-based method
allowed by Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based
Compensation, which does not require the recognition of stock-based compensation cost in the income
statement of the financial statements if stock options are granted to employees at market price at
the date of grant.
On July 30, 2001, we granted non-qualified stock options to purchase up to 2,500,000 shares of our
common stock to participants, including our executive officers under the Allergan, Inc. 2001
Premium Priced Stock Option Plan. Each option was issued with three tranches:
37
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
RESULTS OF OPERATIONS (Continued)
Each tranche of an option vests and becomes exercisable upon the earlier of the date on which the
fair value of a share of our common stock equals or exceeds the applicable exercise price or five
years from the grant date of the option (July 30, 2006). The options expire six years from the
grant date of the option (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 our common stock exceeding $88.55.
In response to FAS 123R, on April 25, 2005, the organization and compensation committee of our
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 our current employees,
including our executive officers, and certain former employees who received grants while employees
prior to the June 2002 spin-off of Advanced Medical Optics (AMO). The former employees are current
employees of AMO. As a result of the acceleration, the second tranche and third tranche of each
such option will become immediately vested and exercisable effective as of May 10, 2005, subject to
the consent of the option holder. Unlike typical stock options that vest over a predetermined
period, the options automatically vest as soon as they are in the money. Consequently, as soon as
the options have any value to the participant, they vest according to their terms. Therefore,
early vesting does not provide any immediate benefit to participants, including our executive
officers.
The acceleration of the options eliminates future compensation expense that we would otherwise
recognize in our income statement with respect to the vesting of these options following the
effectiveness of FAS 123R. Assuming that no holders of the options elect to decline the
acceleration, the maximum future expense that is eliminated is
approximately $1.6 million (of which
approximately $0.2 million is attributable to options held by executive officers). This amount
will instead be reflected in pro forma footnote disclosure to the 2005 financial statements. This
footnote treatment is permitted under the transition guidance provided by FAS 123R.
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:
38
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
LIQUIDITY AND CAPITAL RESOURCES (Continued)
Historically, we have generated cash from operations in excess of working capital requirements. The
net cash provided by operating activities for the three months ended March 25, 2005 was $90.9
million compared to cash provided of $47.9 million for the three months ended March 26, 2004. The
increase in net cash provided by operating activities of $43.0 million was primarily due to an
increase in earnings, including the effect of non-cash items, a decrease in cash required to fund
growth in trade receivables, an increase in accounts payable and a decrease in other non-current
assets. These increases in operating cash flow were partially offset by a decrease in income taxes
payable, principally due to an increase in income taxes paid, a decrease in accrued expenses, an
increase in inventories, primarily for eye care pharmaceuticals and
Botox
®, and higher interest
paid. In the first three months of 2005 and 2004, we paid pension contributions of $1.5 million
and $2.0 million, respectively, to our U.S. defined benefit pension plan. In 2005, we currently
expect to pay contributions of between $14.3 million and $16.3 million for our U.S. and non-U.S.
pension plans.
At December 31, 2004, we disclosed consolidated unrecognized net actuarial losses of $166.3
million, 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 three months of 2005 was $13.9 million. Net
cash used in investing activities in the first three months of 2004 was $18.1 million. We invested
$11.5 million in new facilities and equipment during the three months ended March 25, 2005 compared
to $15.1 million during the same period in 2004. Net cash used in investing activities also
includes $3.3 million and $3.0 million to acquire software during the three months ended March 25,
2005 and March 26, 2004, respectively. We currently expect to invest between $55 million to $60
million in expenditures for manufacturing and laboratory facilities and other property, plant and
equipment during 2005. As discussed in Note 14, Subsequent Event, in our unaudited condensed consolidated
financial statements, we expect to pay $110.0 million in
April 2005 in connection with a certain royalty buy-out agreement. We expect to fund this payment from existing
cash and equivalents.
Net cash used in financing activities was $108.1 million in the first three months of 2005
compared to net cash provided by financing activities of $29.9 million in the first three months
of 2004. Dividends paid to stockholders
39
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
LIQUIDITY AND CAPITAL RESOURCES (Continued)
were $13.1 million in the first three months of 2005 compared to $11.8 million for the same
period in 2004. Effective April 26, 2005, our Board of Directors declared a quarterly cash
dividend of $0.10 per share, payable on June 8, 2005 to stockholders of record on May 13, 2005.
Receipts from the sale of stock to employees were $3.9 million in the first three months of 2005
compared to $49.8 million in the same period last year. During the first three months of 2005,
we repaid $4.6 million in notes payable compared to net borrowings of $4.0 million in the first
three months of 2004. During the first three months of 2005, we repurchased $94.3 million of
treasury stock. During the first three months of 2004, we repurchased $1.7 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 March 25, 2005, we held approximately 3.8 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 March 25, 2005, we had a committed domestic 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 domestic 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 $28.2 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 $8.3 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 domestic 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 were in
compliance with these covenants at March 25, 2005. As of March 25, 2005, we had no borrowings
under our domestic committed credit facility or commercial paper program, $4.1 million in
borrowings outstanding under our committed foreign line of credit, $4.0 million outstanding in
borrowings under various foreign bank loans and $56.8 million in borrowings outstanding under the
medium term note program.
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%
40
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
LIQUIDITY AND CAPITAL RESOURCES (Continued)
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 March 25, 2005, the conversion criteria had not been met. As a sensitivity
measure, the incremental dilutive effect to be used in the computation of diluted earnings per
share from the assumed conversion of the Senior Notes would have been an increase of approximately
1.1 million shares of common stock to the total number of diluted shares used to compute diluted
earnings per share for the three month period ended March 25, 2005, if the closing price of our
common stock during the specified conversion periods averaged $90.01 per share (the minimum price
allowed for conversion during the periods) and any amounts above the accreted value were settled in
common stock.
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.
A substantial portion of our existing cash and equivalents are held by non-U.S. subsidiaries. We
currently plan to use these funds in our operations outside the United States. Withholding and
U.S. taxes have not been provided for unremitted earnings of certain non-U.S. subsidiaries because
we have currently reinvested or expect to reinvest these earnings permanently in such operations.
As of December 31, 2004, we had approximately $1,011 million in unremitted earnings outside the
United
41
Allergan, Inc.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE
QUARTER ENDED MARCH 25, 2005 (Continued)
LIQUIDITY AND CAPITAL RESOURCES (Continued)
States for which withholding and U.S. taxes have not been provided. Tax costs would be incurred if
these funds were remitted to the United States.
On October 22, 2004, the American Jobs Creation Act of 2004, or the Act, was enacted in the United
States. We are currently evaluating the impact of the Act on our operations and effective tax
rate. In particular, we are evaluating the Acts provisions relating to incentives to reinvest
foreign earnings in the United States, which require a domestic reinvestment plan to be created and
approved by our board of directors before executing any repatriation activities. At this time, we
have not completed our evaluation. We expect to complete our evaluation by the end of our third
fiscal quarter of 2005. The range of reasonably possible amounts of unremitted foreign earnings
that may be considered for repatriation under the provisions of the Act is currently between zero
and $674 million. The related range of estimated income tax effects on such repatriation is
currently between zero and $60 million.
Our manufacturing and supply agreement with AMO is scheduled to terminate in June 2005. We
currently estimate that we will incur between $24 million and $28 million of total restructuring
costs associated with the termination of that agreement and related exit activities. We expect
approximately $24 million of the restructuring charges to be cash charges. As of March 25, 2005, we
recorded cumulative pre-tax restructuring charges of $13.8 million beginning in the fourth quarter
of 2004 up through and including the first quarter of 2005 and expect to complete the additional
restructuring activities by the end of the fourth quarter of 2005.
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 are expected to be incurred beginning in the first quarter
of 2005 and continuing 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 quarter of 2005, we recorded pre-tax restructuring charges
of $20.7 million and transition/duplicate operating expenses of $0.3 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.
42
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 March 25, 2005, we had approximately $7.3 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 $0.1 million.
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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 March 25, 2005 and December 31, 2004.
44
Allergan, Inc.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (Continued)
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.
45
Allergan, Inc.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (Continued)
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 and the Japanese
yen.
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 March 25, 2005 and December 31, 2004. The information is provided in
U.S. dollar amounts, as presented in our consolidated financial statements.
46
Allergan, Inc.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (Continued)
47
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
48
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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, 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 is seeking German regulatory approval for a
botulinum toxin currently expected to be launched during the second half of 2005, and a Korean
company is developing a botulinum toxin that received exportation approval from Korean authorities
in early 2005 and that is expected to be launched in Korea during 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
49
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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, Restasis®, Zymar
® and
Botox®,
as well as FDA approval of new indications for Botox®,
and new products such as
Combigan
, our
Lumigan
®/
Timolol
combination,
Posurdex
® and the oral
formulation of tazarotene. 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, 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. For example, in July 2004 an FDA advisory panel voted
against approval for the oral formulation of tazarotene, and in September 2004 we received a
non-approvable letter from the FDA for that product. 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
50
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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:
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
51
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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 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
52
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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.
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
53
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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. 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
54
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
third party payors or other restrictions could negatively and materially impact our revenues and
financial condition. We encounter similar regulatory and legislative issues in most countries
outside the United States.
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:
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
55
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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 8, Litigation,
in the notes to the unaudited condensed consolidated financial 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
56
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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 also need 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 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
57
ALLERGAN, INC.
CERTAIN FACTORS AND TRENDS AFFECTING ALLERGAN AND ITS BUSINESSES (Continued)
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,
post-marketing clinical studies mandated by the FDA, 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 criminal prosecution. 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.
58
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.
59
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 March 25, 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.
60
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.
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 Syntex, 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. Oral argument on
the appeal took place on November 1, 2004 and we are currently awaiting the Court of Appeals
ruling. If the Court of Appeals reverses the prior judgment in our favor,
Acular
® could face
immediate generic competition. 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 has been
continued to summer 2005.
On January 23, 2003, a complaint entitled Irena Medavoy and Morris Mike Medavoy v. Arnold W.
Klein, M.D., et al. and Allergan, Inc. was filed in the Superior Court of the State of California
for the County of Los Angeles. The complaint contained, among other things, allegations against us
of negligence, unfair business practices, product liability, intentional misconduct, fraud,
negligent misrepresentation, strict liability in tort, improper off-label promotion and loss of
consortium. The complaint also contained separate allegations against the other defendants. On
April 10, 2003, Morris Mike Medavoy voluntarily served on us a Request for Dismissal Without
Prejudice for the only two causes of action he asserted in the complaint. The causes of action
asserted by Irena Medavoy against us were not affected by this Request for Dismissal. On July 8,
2003, Irena Medavoy filed a First Amended Complaint, adding allegations against us of false and/or
misleading advertising and unjust enrichment, as well as false and/or misleading advertising and
unfair competition. A jury trial in the matter began on August 31, 2004. On October 8, 2004, the
jury ruled in favor of us and Dr. Klein. Also on October 8, 2004, the court dismissed the unfair
business practices claims against us and Dr. Klein. On November 29, 2004, Irena Medavoy filed a
Motion for New Trial. On December 16, 2004, the court denied Irena Medavoys Motion for a New
Trial. On January 13, 2005, Irena Medavoy filed a Notice of Appeal with the Clerk of Court of the
Superior Court of the State of California for the County of Los Angeles and her opening appellate
brief is due on May 31, 2005.
61
Allergan, Inc.
Litigation (Continued)
On June 2, 2003, a complaint entitled Klein-Becker usa, LLC v. Allergan, Inc. was filed in the
United Stated District Court for the District of Utah Central Division. The complaint, as later
amended, contained claims against us for declaratory relief, intentional interference with
contractual and economic relations, unfair competition under federal and Utah law, 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, declaratory relief, and trademark infringement and dilution, and alleging
that Klein-Beckers advertisements for its anti-wrinkle cream that use the heading Better than
BOTOX®? are false and misleading. 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 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. The court has not set a hearing date for either motion. Trial is scheduled for
August 1, 2005.
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 under section 505(b)(2) of the Federal Food,
Drug, and Cosmetic Act 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. A claim
construction hearing is scheduled for June 7, 2005. 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, which names
us and 12 other defendants, alleges unfair business practices based upon a price fixing
62
Allergan, Inc.
Litigation (Continued)
conspiracy in connection with the reimportation of pharmaceuticals from Canada. On September 3,
2004, the plaintiffs filed a first amended complaint, making various modifications to the original
complaint. 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 defendants again filed a demurrer. The hearing on the demurrer to the second amended complaint
was held on April 8, 2005 and the court took the matter under submission.
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.
63
Allergan, Inc.
Issuer Purchases of Equity Securities
The following table discloses the purchases of our equity securities during the first fiscal
quarter of 2005.
Item 5. Other Information.
Other Information
None.
64
Allergan, Inc.
Item 6. Exhibits
65
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.
66
INDEX TO EXHIBITS
67
(in millions, except share data)
Table of Contents
(in millions)
Table of Contents
Table of Contents
Three months ended
March 25,
March 26,
(in millions, except per share amounts)
2005
2004
$
79.9
$
80.8
2.2
2.0
(10.5
)
(10.9
)
$
71.6
$
71.9
$
0.61
$
0.62
$
0.60
$
0.60
$
0.55
$
0.55
$
0.54
$
0.54
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Employee
Other
Severance
Costs
Total
$
20.5
$
0.2
$
20.7
(0.8
)
(0.2
)
(1.0
)
$
19.7
$
$
19.7
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Table of Contents
(in millions)
March 25,
December 31,
2005
2004
$
4.6
$
4.6
3.1
3.2
0.8
0.9
$
8.5
$
8.7
March 25,
December 31,
(in millions)
2005
2004
$
56.7
$
50.5
21.8
23.2
19.7
16.2
$
98.2
$
89.9
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Three months ended
March 25,
March 26,
(in millions, except per share amounts)
2005
2004
$
79.9
$
80.8
131.1
130.8
1.0
2.2
0.5
1.3
132.6
134.3
$
0.61
$
0.62
$
0.60
$
0.60
Table of Contents
Three months ended
(in millions)
March 25, 2005
March 26, 2004
Tax
Tax
Before-tax
(expense)
Net-of-tax
Before-tax
(expense)
Net-of-tax
amount
or benefit
amount
amount
or benefit
amount
$
(3.3
)
$
$
(3.3
)
$
(1.5
)
$
$
(1.5
)
(0.3
)
0.1
(0.2
)
0.2
(0.1
)
0.1
$
(3.6
)
$
0.1
(3.5
)
$
(1.3
)
$
(0.1
)
(1.4
)
79.9
80.8
$
76.4
$
79.4
Table of Contents
Net Sales
(in millions)
Three months ended
March 25,
March 26,
2005
2004
$
331.7
$
309.8
96.9
73.2
26.2
21.7
32.6
28.7
18.8
15.9
506.2
449.3
21.0
23.1
$
527.2
$
472.4
Long-Lived Assets
(in millions)
March 25,
December 31,
2005
2004
$
160.3
$
162.6
34.9
37.2
20.8
22.1
15.5
17.3
0.7
0.7
232.2
239.9
263.4
266.0
378.3
375.1
$
873.9
$
881.0
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Item 2.
Managements Discussion and Analysis of Financial Condition and Results of Operations
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Employee
Other
Severance
Costs
Total
$
20.5
$
0.2
$
20.7
(0.8
)
(0.2
)
(1.0
)
$
19.7
$
$
19.7
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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.
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.
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MARCH 25, 2005
Fair
Maturing in
Market
2005
2006
2007
2008
2009
Thereafter
Total
Value
(in millions, except interest rates)
$
50.0
$
50.0
$
50.0
3.02
%
3.02
%
695.4
695.4
695.4
2.73
%
2.73
%
31.2
31.2
31.2
3.13
%
3.13
%
73.2
73.2
73.2
2.60
%
2.60
%
$
849.8
$
849.8
$
849.8
2.75
%
2.75
%
$
515.2
$
31.8
$
25.0
$
572.0
$
623.6
1.25
%
3.56
%
7.47
%
1.65
%
$
0.8
0.8
0.8
13.40
%
13.40
%
7.3
7.3
7.3
2.48
%
2.48
%
$
8.1
$
515.2
$
31.8
$
25.0
$
580.1
$
631.7
3.60
%
1.25
%
3.56
%
7.47
%
1.68
%
Table of Contents
DECEMBER 31, 2004
Fair
Maturing in
Market
2005
2006
2007
2008
2009
Thereafter
Total
Value
(in millions, except interest rates)
$
100.0
$
100.0
$
100.0
2.37
%
2.37
%
648.9
648.9
648.9
2.23
%
2.23
%
26.0
26.0
26.0
2.47
%
2.47
%
54.9
54.9
54.9
2.18
%
2.18
%
$
829.8
$
829.8
$
829.8
2.25
%
2.25
%
$
513.6
$
31.5
$
25.0
$
570.1
$
690.7
1.25
%
3.56
%
7.47
%
1.65
%
$
1.4
1.4
1.4
13.32
%
13.32
%
11.7
11.7
11.7
1.46
%
1.46
%
$
13.1
$
513.6
$
31.5
$
25.0
$
583.2
$
703.8
2.73
%
1.25
%
3.56
%
7.47
%
1.67
%
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March 25, 2005
December 31, 2004
Average Contract
Average Contract
Notional
Rate or
Notional
Rate or
Amount
Strike Amount
Amount
Strike Amount
(in millions)
(in millions)
$
17.8
1.22
$
22.0
1.22
8.3
11.82
10.1
11.75
9.0
0.74
11.0
0.74
6.0
3.09
6.6
3.06
21.8
1.33
22.4
1.32
6.5
102.02
7.4
102.21
2.8
1.90
2.9
1.90
$
72.2
$
82.4
$
1.6
$
1.6
$
$
1.0
1.92
$
$
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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.
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adverse changes in tariff and trade protection measures;
unexpected changes in foreign regulatory requirements;
potentially negative consequences from changes in or interpretations of tax laws;
differing labor regulations;
changing economic conditions in countries where our products are sold or manufactured or
in other countries;
differing local product preferences and product requirements;
exchange rate risks;
restrictions on the repatriation of funds;
political unrest and hostilities;
differing degrees of protection for intellectual property; and
difficulties in coordinating and managing foreign operations.
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Total Number
of Shares
Maximum Number
Purchased as
(or Approximate
Part of
Dollar Value) of
Publicly
Shares that May
Total Number
Average
Announced
Yet Be Purchased
of Shares
Price Paid
Plans
Under the Plans
Period
Purchased(1)
per Share
or Programs
or Programs(2)
0
$
N/A
0
6,373,362
0
$
N/A
0
6,550,367
1,256,600
$
75.00
1,256,600
5,352,684
1,256,600
$
75.00
1,256,600
N/A
(1)
The Company maintains an evergreen stock repurchase program, which was first announced on
September 28, 1993. Under the stock repurchase program, the Company may maintain up to 9.2
million repurchased shares in its treasury account at any one time. As of March 25, 2005, the
Company held approximately 3.8 million treasury shares under this program.
(2)
The following share numbers reflect the maximum number of shares that may be purchased under
the Companys stock repurchase program and are as of the end of each of the respective
periods.
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Date: April
27
, 2005
ALLERGAN, INC.
/s/ Eric K. Brandt
Eric K. Brandt
Executive Vice President,
Finance and Technical Operations,
Chief Financial Officer
(Principal Financial Officer)
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Exhibit 10.57
Acceleration of Vesting of Premium Priced Stock Options
On April 25, 2004, the Organization and Compensation Committee of the Allergan, Inc. (the Company) Board of Directors approved an acceleration of the vesting of options issued under the Allergan, Inc. 2001 Premium Priced Stock Option Plan (the Plan) that are held by the Companys current employees, including its executive officers, and certain former employees who received grants while employees of the Company prior to the Companys June 2002 spin-off of Advanced Medical Optics, Inc. (AMO). As a result of the acceleration, the second tranche and third tranche of each option issued under the Plan will become vested and exercisable effective as of May 10, 2005, subject to the consent of the option holder. Unlike typical stock options that vest over a predetermined period, the options issued under the Plan automatically vest as soon as they are in the money. Consequently, as soon as the options have any value to the participant, they vest according to their terms. Therefore, early vesting of the options does not provide any immediate benefit to participants, including the Companys executive officers.
The following table summarizes the options subject to acceleration, each of which has a weighted average exercise price equal to $116.88695:
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
I, David E.I. Pyott, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Allergan, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |||
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |||
| (c) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |||
| (d) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and | |||
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent functions):
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and | |||
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. | |||
/s/ DAVID E.I. PYOTT
David E.I. Pyott
Chairman of the Board, President and
Chief Executive Officer
(Principal Executive Officer)
Date: April 25 , 2005
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
I, Eric K. Brandt, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Allergan, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |||
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |||
| (c) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |||
| (d) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and | |||
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent functions):
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and | |||
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. | |||
/s/ ERIC K. BRANDT
Eric K. Brandt
Executive Vice President,
Finance, Strategy and Corporate Development
(Principal Financial Officer)
Date: April 25 , 2005
EXHIBIT 32
The following certifications are being furnished solely to accompany the Report pursuant to 18
U.S.C. § 1350 and in accordance with SEC Release No. 33-8238. These certifications shall not be
deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor
shall they be incorporated by reference in any filing of the Company under the Securities Act of
1933, as amended, whether made before or after the date hereof, regardless of any general
Certification of Principal Executive Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned officer of Allergan, Inc., a Delaware corporation (the Company), hereby certifies, to
his knowledge, that:
Dated: April
25
, 2005
A signed original of this written statement required by Section 906 has been provided to
Allergan, Inc. and will be retained by Allergan, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
Certification of Principal Financial Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned officer of Allergan, Inc., a Delaware corporation (the Company), hereby certifies, to
his knowledge, that:
Dated: April
25
, 2005
A signed original of this written statement required by Section 906 has been provided to
Allergan, Inc. and will be retained by Allergan, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
(i)
the accompanying Quarterly Report on Form 10-Q of the Company for the period ended March 25,
2005 (the Report) fully complies with the requirements of Section 13(a) or Section 15(d), as
applicable, of the Securities Exchange Act of 1934, as amended; and
(ii)
the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
/s/ DAVID E.I. PYOTT
David E.I. Pyott
Chairman of the Board, President and
Chief Executive Officer
(Principal Executive Officer)
(i)
the accompanying Quarterly Report on Form 10-Q of the Company for the period ended March 25,
2005 (the Report) fully complies with the requirements of Section 13(a) or Section 15(d), as
applicable, of the Securities Exchange Act of 1934, as amended; and
(ii)
the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
/s/ ERIC K. BRANDT
Eric K. Brandt
Executive Vice President,
Finance, Strategy and Corporate Development
(Principal Financial Officer)