Notes to the Condensed Consolidated Financial Statements (unaudited)
1. General
The accompanying unaudited interim condensed consolidated financial statements have been prepared pursuant to the rules
and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the United States (U.S. GAAP) for complete consolidated financial statements have been
condensed or are not included herein. The interim statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Companys Annual Report on Form 10-K for the year ended
December 31, 2012 (the Annual Report).
The results of operations of any interim period are not necessarily
indicative of the results of operations for the full year. The unaudited interim condensed consolidated financial information presented herein reflects all normal adjustments that are, in the opinion of management, necessary for a fair statement of
the financial position, results of operations and cash flows for the periods presented. The Company is responsible for the unaudited interim condensed consolidated financial statements included in this report. The Company has made certain
reclassifications to prior period information to conform to the current period presentation. All intercompany transactions and balances have been eliminated in consolidation.
2. Actavis Transaction
On May 19, 2013, the Company entered into a Transaction Agreement (the Transaction Agreement) with,
among others, Actavis, Inc., a Nevada corporation (Actavis), Actavis Limited, a private limited company organized under the laws of Ireland (New Actavis), and Actavis W.C. Holding 2 LLC, a limited liability company organized
in Nevada and a wholly-owned subsidiary of New Actavis (U.S. Merger Sub). Under the terms of the Transaction Agreement, (a) New Actavis will acquire the Company (the Acquisition) pursuant to a scheme of arrangement under
Section 201 of the Irish Companies Act 1963 (the Scheme) and (b) U.S. Merger Sub will merge with and into Actavis, with Actavis as the surviving corporation in the merger (the Merger and, together with the
Acquisition, the Transaction). At the effective time of the Scheme, each of the Companys shareholders will be entitled to receive 0.160 of a newly issued New Actavis ordinary share in exchange for each ordinary share of the Company
held by such shareholder. Cash will be paid in lieu of any fractional shares of New Actavis. At the effective time of the Merger, each outstanding Actavis common share will be converted into the right to receive one New Actavis ordinary
share. As a result of the Transaction, both the Company and Actavis will become wholly owned subsidiaries of New Actavis.
The
Transaction Agreement provides that if the Transaction Agreement is terminated (i) by the Company following the board of directors of Actavis changing its recommendation to the Actavis stockholders to approve the Transaction Agreement (except
in limited circumstances) or (ii) by the Company or Actavis following the failure of the Actavis stockholders to approve the Transaction Agreement following the board of directors of Actavis changing its recommendation (except in limited
circumstances), then Actavis shall pay to the Company $160 million, subject to reduction in certain circumstances. The Transaction Agreement also contains customary representations, warranties and covenants by Actavis and the Company.
In addition, on May 19, 2013, the Company and Actavis entered into an Expenses Reimbursement Agreement (the ERA), the
terms of which have been consented to by the Irish Takeover Panel for purposes of Rule 21.2 of the Irish Takeover Rules only. Under the ERA, the Company has agreed to pay to Actavis the documented, specific and quantifiable third party costs and
expenses incurred by Actavis in connection with the Acquisition upon the termination of the Transaction Agreement in certain specified circumstances. The maximum amount payable by the Company to Actavis pursuant to the ERA is an amount equal to one
percent of the aggregate value of the Companys issued share capital.
The proposed Transaction has been unanimously
approved by the boards of directors of Actavis and the Company, and is supported by the management teams of both companies. The Company currently expects the Transaction to close in the second half of 2013, subject to the satisfaction of customary
closing conditions, including the approval of the shareholders of both companies, certain regulatory approvals and the approval of the Irish High Court. On July 11, 2013, Actavis and the Company announced that they had each received a request for
additional information from the Federal Trade Commission (FTC) in connection with the Transaction. The effect of the second request is to extend the waiting period imposed by the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, until 30 days after Actavis and the Company have substantially complied with the request, unless that period is extended voluntarily by the parties or terminated sooner by the FTC. On July 15, 2013, the German Federal Cartel Office granted
clearance in connection with the Transaction.
3. Summary of Significant Accounting Policies
The following are interim updates to certain of the policies described in Note 2 of the notes to the
Companys audited consolidated financial statements for the year ended December 31, 2012 included in the Annual Report.
Revenue Recognition
Revenue from product sales is recognized when title and risk of loss to the product transfers to the customer, which is based on the transaction shipping terms. Recognition of revenue also requires
reasonable assurance of collection of sales proceeds and the completion of all performance obligations. The Company warrants products against defects and for specific quality standards, permitting the return of products under certain circumstances.
Product sales are recorded net of all sales-related deductions including, but not limited to: trade discounts, sales returns and allowances, commercial and government rebates, customer loyalty programs and fee for service arrangements with certain
distributors. The Company establishes provisions for its sales-related deductions in the same
6
period that it recognizes the related gross sales based on select criteria for estimating such contra revenues including, but not limited to: contract terms, government regulations, estimated
utilization or redemption rates, costs related to the programs and other historical data. These reserves reduce revenues and are included as either a reduction of accounts receivable or as a component of liabilities. No material revisions were made
to the methodology used in determining these reserves during the quarter and six months ended June 30, 2013.
As of
June 30, 2013 and December 31, 2012, the amounts related to all sales-related deductions included as a reduction of accounts receivable were $27 million and $31 million, respectively. The amounts related to all sales-related reductions
included as liabilities were $407 million (of which $124 million related to reserves for product returns) and $434 million (of which $118 million related to reserves for product returns) as of June 30, 2013 and December 31, 2012,
respectively. The provisions recorded to reduce gross sales to net sales were $175 million and $200 million in the quarters ended June 30, 2013 and 2012, respectively, and $373 million and $448 million in the six months ended June 30, 2013
and 2012, respectively.
In early 2010, the U.S. Patient Protection and Affordable Care Act of 2010 was signed into law. This
statute impacts the Companys net sales by increasing certain rebates it pays per prescription, most notably managed Medicaid rebates and the Medicare Part D, or donut hole rebates. Included in the provisions recorded to reduce
gross sales to net sales are the current provisions related to sales due to the increased Medicaid rebates and donut hole rebates, which totaled $11 million and $12 million in the quarters ended June 30, 2013 and 2012, respectively, and $30
million and $33 million in the six months ended June 30, 2013 and 2012, respectively.
In the quarter ended
March 31, 2013, the Company shipped initial trade units of DELZICOL (mesalamine) 400 mg delayed-release capsules, its 400 mg mesalamine product indicated for the treatment of mildly to moderately active ulcerative colitis and for the
maintenance of remission of ulcerative colitis. As a result of the terms pursuant to which such initial shipments were made, the Company deferred $44 million of the gross revenues (which do not account for applicable sales-related deductions)
generated thereby in accordance with Financial Accounting Standards Board Accounting Standards Codification (ASC) Topic 605 Revenue Recognition since the criteria to record such revenues were not met as of March 31,
2013. The Company recognized all of such deferred gross revenues (as reduced to account for applicable sales-related deductions) in its condensed consolidated statement of operations for the quarter ended June 30, 2013 as the criteria to record
such revenues were achieved.
Deferred Loan Costs
Expenses associated with the issuance of indebtedness are capitalized and amortized as a component of interest expense over the term of the respective financing arrangements using the effective interest
method. In the event that long-term debt is prepaid, the deferred loan costs associated with such indebtedness are expensed as a component of interest expense in the period in which such prepayment is made. Interest expense resulting from the
amortization and write-offs of deferred loan costs amounted to $11 million and $5 million in the quarters ended June 30, 2013 and 2012, respectively, and $25 million and $17 million in the six months ended June 30, 2013 and 2012,
respectively. Aggregate deferred loan costs, net of accumulated amortization, were $55 million and $80 million as of June 30, 2013 and December 31, 2012, respectively, of which $12 million and $16 million were included in prepaid expenses
and other current assets in the condensed consolidated balance sheets, respectively, and $43 million and $64 million were recorded in other non-current assets in the condensed consolidated balance sheets, respectively.
Restructuring Costs
The Company records liabilities for costs associated with exit or disposal activities in the period in which the liability is incurred. In accordance with existing benefit arrangements, employee severance
costs are accrued when the restructuring actions are probable and estimable. Costs for one-time termination benefits where the employee is required to render service until termination in order to receive the benefits are recognized ratably over the
future service period. Curtailment (gains) / losses associated with defined benefit arrangements for severed employees are recognized in accordance with ASC Topic 715 CompensationRetirement Benefits. See Note 4 for more
information.
4. Strategic Initiatives
Western European Restructuring
In April 2011, the Company announced a plan to restructure its operations in Belgium, the Netherlands, France, Germany, Italy, Spain, Switzerland and the United Kingdom. The restructuring did not impact
the Companys operations at its headquarters in Dublin, Ireland, its facilities in Dundalk, Ireland, Larne, Northern Ireland or Weiterstadt, Germany or its commercial operations in the United Kingdom. The Company determined to proceed with the
restructuring following the completion of a strategic review of its operations in its Western European markets where its product ACTONEL lost exclusivity in late 2010. ACTONEL accounted for approximately 70% of the Companys Western European
revenues in the year ended December 31, 2010. In connection with the restructuring, the Company has moved to a wholesale distribution model in the affected jurisdictions to minimize operational costs going forward. The implementation of the
restructuring plan impacted approximately 500 employees in total. In the quarter ended June 30, 2013, the Company recorded restructuring income of $2 million, which was comprised of pretax severance income of $1 million recorded based on
estimated future payments in accordance with specific contractual terms and employee specific events and pension-related
7
curtailment gains of $1 million. In the six months ended June 30, 2013, the Company recorded restructuring income of $3 million, which was comprised of pretax severance income of $3 million
recorded based on estimated future payments in accordance with specific contractual terms and employee specific events and pension-related curtailment gains of $1 million, offset, in part, by non-personnel related costs of $1 million.
In the quarter ended June 30, 2012, the Company incurred pretax severance costs of $7 million, which were offset, in full, by
pension-related curtailment gains of $7 million. In the six months ended June 30, 2012, the Company recorded restructuring costs of $50 million, which were comprised of pretax severance costs of $57 million and other restructuring costs of $1
million, offset, in part, by pension-related curtailment gains of $8 million.
The Company does not expect to record any
material expenses relating to the Western European restructuring in future periods. The majority of the remaining severance-related costs and other liabilities are expected to be settled in cash within the next twelve months.
Severance Liabilities
The following table summarizes the activity in the Companys aggregate severance liabilities during the quarter and six months ended June 30, 2013:
|
|
|
|
|
(dollars in millions)
|
|
|
|
Balance, December 31, 2012
|
|
$
|
32
|
|
Western European severance adjustments included in restructuring (income)
|
|
|
(2
|
)
|
Cash payments during the period
|
|
|
(6
|
)
|
|
|
|
|
|
Balance, March 31, 2013
|
|
$
|
24
|
|
|
|
|
|
|
Western European severance adjustments included in restructuring (income)
|
|
|
(1
|
)
|
Cash payments during the period
|
|
|
(8
|
)
|
Foreign currency translation adjustments and other
|
|
|
1
|
|
|
|
|
|
|
Balance, June 30, 2013
|
|
$
|
16
|
|
|
|
|
|
|
5. ENABLEX Acquisition
The Company and Novartis Pharmaceuticals Corporation (Novartis) were parties to an agreement to co-promote
ENABLEX, developed by Novartis, in the United States. On October 18, 2010, the Company acquired the U.S. rights to ENABLEX from Novartis for an upfront payment of $400 million in cash at closing, plus potential future milestone payments of up
to $20 million in the aggregate, subject to the achievement of pre-defined 2011 and 2012 ENABLEX net sales thresholds (the ENABLEX Acquisition). At the time of the ENABLEX Acquisition, $420 million was recorded as a component of
intangible assets and is being amortized on an accelerated basis over the period of the projected cash flows for the product. Concurrent with the closing of the ENABLEX Acquisition, the Company and Novartis terminated their existing co-promotion
agreement, and the Company assumed full control of sales and marketing of ENABLEX in the U.S. market. In connection with the ENABLEX Acquisition, Novartis agreed to manufacture ENABLEX for the Company until October 2013. Novartis also currently
packages ENABLEX for the Company.
In the quarter ended June 30, 2012, the Company concluded that it was no longer
probable, as defined by ASC Topic 450 Contingencies, that the contingent milestone payments to Novartis would be required to be paid. As a result, the Company reversed the related liability and recorded a $20 million gain, which reduced
selling, general and administrative (SG&A) expenses in the quarter and six months ended June 30, 2012.
6. Shareholders (Deficit)
In November 2011, the Company announced that its Board of Directors had authorized the redemption of up to an aggregate
of $250 million of its ordinary shares (the Prior Redemption Program). Pursuant to the Prior Redemption Program, the Company recorded the redemption of 1.9 million ordinary shares (at an aggregate cost of $32 million), in the six
months ended June 30, 2012. Following the settlement of such redemptions, the Company cancelled all shares redeemed. As a result of the redemptions recorded during the six months ended June 30, 2012, in accordance with ASC Topic 505
Equity, the Company recorded a decrease in ordinary shares at par value of $0.01 per share, and an increase in an amount equal to the aggregate purchase price above par value in accumulated deficit of approximately $32 million in the six
months ended June 30, 2012. The Prior Redemption Program allowed the Company to redeem up to an aggregate of $250 million of its ordinary shares and was to terminate on the earlier of December 31, 2012 or the redemption by the Company of
an aggregate of $250 million of its ordinary shares. On August 7, 2012, the Company announced that its Board of Directors had authorized the renewal of the Prior Redemption Program. The renewed program (the Current Redemption
Program) replaced the Prior Redemption Program and allows the Company to redeem up to an aggregate of $250 million of its ordinary shares in addition to those redeemed under the Prior Redemption Program. The Current Redemption
8
Program will terminate on the earlier of December 31, 2013 or the redemption by the Company of an aggregate of $250 million of its ordinary shares. As of June 30, 2013, the Company
had not redeemed any ordinary shares under the Current Redemption Program, and consequently $250 million remained available for redemption thereunder. The Current Redemption Program does not obligate the Company to redeem any number of ordinary
shares or an aggregate of ordinary shares equal to the full $250 million authorization and may be suspended at any time or from time to time. Under the terms of the Transaction Agreement, the Companys ability to redeem ordinary shares is
subject to Actaviss consent.
On August 7, 2012, the Company announced a dividend policy (the Dividend
Policy) relating to the payment of a total annual cash dividend to its ordinary shareholders of $0.50 per share in equal semi-annual installments of $0.25 per share. Any declaration by the Companys Board of Directors to pay future cash
dividends subsequent to the June 2013 semi-annual dividend described below is subject to Actaviss consent under the terms of the Transaction Agreement and would also depend on the Companys earnings and financial condition and other
relevant factors at such time.
On June 14, 2013, the Company paid a semi-annual cash dividend under the Dividend Policy
in the amount of $0.25 per share, or $63 million in the aggregate. At the time of the June 2013 semi-annual dividend the Companys retained earnings were in a deficit position and consequently the June 2013 semi-annual dividend reduced the
additional paid-in-capital of the Company from $17 million to zero as of May 31, 2013 and increased the Companys accumulated deficit by $46 million.
The Company has operations in the United States, Puerto Rico, United Kingdom, Republic of Ireland, Australia, Canada and many other Western European countries. The results of its non-U.S. dollar based
operations are translated to U.S. dollars at the average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at
the date of the equity transaction. Translation adjustments are reflected in shareholders (deficit) as a component of accumulated other comprehensive (loss). The Company also realizes foreign currency gains / (losses) in the normal course of
business based on movement in the applicable exchange rates. These gains / (losses) are included as a component of SG&A.
The movements in accumulated other comprehensive (loss) for the quarter and six months ended June 30, 2013 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Cumulative
Translation
Items
|
|
|
Defined Benefit
Plan Items
|
|
|
Total
Accumulated
Other
Comprehensive
(Loss)
|
|
Balance as of December 31, 2012
|
|
$
|
(25
|
)
|
|
$
|
(10
|
)
|
|
$
|
(35
|
)
|
Other comprehensive (loss)/income before reclassifications into SG&A
|
|
|
(8
|
)
|
|
|
2
|
|
|
|
(6
|
)
|
Amounts reclassified from accumulated other comprehensive (loss) into SG&A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive (loss)/income
|
|
|
(8
|
)
|
|
|
2
|
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2013
|
|
|
(33
|
)
|
|
|
(8
|
)
|
|
|
(41
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income before reclassifications into SG&A
|
|
|
3
|
|
|
|
1
|
|
|
|
4
|
|
Amounts reclassified from accumulated other comprehensive (loss) into SG&A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive income
|
|
|
3
|
|
|
|
1
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of June 30, 2013
|
|
$
|
(30
|
)
|
|
$
|
(7
|
)
|
|
$
|
(37
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
The movements in accumulated other comprehensive income / (loss) for the quarter and six
months ended June 30, 2012 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Cumulative
Translation
Items
|
|
|
Defined Benefit
Plan Items
|
|
|
Total
Accumulated
Other
Comprehensive
(Loss)
|
|
Balance as of December 31, 2011
|
|
$
|
(30
|
)
|
|
$
|
4
|
|
|
$
|
(26
|
)
|
Other comprehensive income before reclassifications into SG&A
|
|
|
8
|
|
|
|
|
|
|
|
8
|
|
Amounts reclassified from accumulated other comprehensive income into SG&A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive income
|
|
|
8
|
|
|
|
|
|
|
|
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2012
|
|
|
(22
|
)
|
|
|
4
|
|
|
|
(18
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss) before reclassifications into SG&A
|
|
|
(11
|
)
|
|
|
|
|
|
|
(11
|
)
|
Amounts reclassified from accumulated other comprehensive (loss) into SG&A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive (loss)
|
|
|
(11
|
)
|
|
|
|
|
|
|
(11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of June 30, 2012
|
|
$
|
(33
|
)
|
|
$
|
4
|
|
|
$
|
(29
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7. Earnings Per Share
The Company accounts for earnings per share (EPS) in accordance with ASC Topic 260, Earnings Per
Share (ASC 260) and related guidance, which requires two calculations of EPS to be disclosed: basic and diluted. The numerator in calculating basic and diluted EPS is an amount equal to the consolidated net income for the periods
presented. The denominator in calculating basic EPS is the weighted average shares outstanding for the respective periods. The denominator in calculating diluted EPS is the weighted average shares outstanding, plus the dilutive effect of stock
option grants and unvested restricted share/share unit grants for the respective periods. The following sets forth the basic and diluted calculations of EPS for the quarters and six months ended June 30, 2013 and 2012:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in millions, except per share amounts)
|
|
Quarter Ended
June 30, 2013
|
|
|
Quarter Ended
June 30, 2012
|
|
|
Six Months Ended
June 30, 2013
|
|
|
Six Months Ended
June 30, 2012
|
|
|
|
|
|
|
Net income available to ordinary shareholders
|
|
$
|
108
|
|
|
$
|
53
|
|
|
$
|
221
|
|
|
$
|
166
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of ordinary and potential ordinary shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic number of ordinary shares outstanding
|
|
|
249.6
|
|
|
|
248.2
|
|
|
|
249.3
|
|
|
|
248.2
|
|
|
|
|
|
|
Dilutive effect of grants of stock options and unvested restricted shares/share units
|
|
|
3.2
|
|
|
|
2.1
|
|
|
|
2.4
|
|
|
|
2.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted number of ordinary and potential ordinary shares outstanding
|
|
|
252.8
|
|
|
|
250.3
|
|
|
|
251.7
|
|
|
|
250.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per ordinary share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.43
|
|
|
$
|
0.21
|
|
|
$
|
0.89
|
|
|
$
|
0.67
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
0.43
|
|
|
$
|
0.21
|
|
|
$
|
0.88
|
|
|
$
|
0.66
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Prior Redemption Program decreased each of the weighted average basic shares outstanding and the
weighted average diluted shares outstanding by 1.9 million shares and 1.6 million shares during the quarter and six months ended June 30, 2012, respectively. The remaining 0.3 million shares redeemed in the six months ended
June 30, 2012 were not included in the calculation of basic or diluted EPS for the six months ended June 30, 2012 as their impact was anti-dilutive under the treasury stock method.
10
The following represents amounts not included in the above calculation of diluted EPS as
their impact was anti-dilutive under the treasury stock method, including the implied purchase cost of non-qualified options to purchase ordinary shares and restricted ordinary shares/share units to be repurchased as defined by ASC 260:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in millions)
|
|
Quarter Ended
June 30, 2013
|
|
|
Quarter Ended
June 30, 2012
|
|
|
Six Months Ended
June 30, 2013
|
|
|
Six Months Ended
June 30, 2012
|
|
Stock options to purchase ordinary shares
|
|
|
4.5
|
|
|
|
4.6
|
|
|
|
4.9
|
|
|
|
4.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested restricted shares/share units
|
|
|
2.2
|
|
|
|
2.0
|
|
|
|
3.0
|
|
|
|
2.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8. Sanofi Collaboration Agreement
The Company and Sanofi-Aventis U.S. LLC (Sanofi) are parties to a collaboration agreement pursuant to which
the parties co-develop and market ACTONEL on a global basis, excluding Japan (the Collaboration Agreement). ATELVIA, the Companys risedronate sodium delayed-release product launched in January 2011 and currently sold in the United
States and Canada, is also marketed pursuant to the Collaboration Agreement. As a result of ACTONELs loss of patent exclusivity in Western Europe in late 2010 and as part of the Companys transition to a wholesale distribution model in
Belgium, the Netherlands, France, Germany, Italy, Spain, Switzerland and the United Kingdom, the Company and/or Sanofi reduced or discontinued marketing and promotional efforts in certain territories covered by the Collaboration Agreement. Under the
Collaboration Agreement, the Companys and Sanofis rights and obligations are specified by geographic market. For example, under the Collaboration Agreement, Sanofi generally has the right to elect to participate in the development of
ACTONEL-related product improvements, other than product improvements specifically related to the United States and Puerto Rico, where the Company has full control over all product development decisions following the April 2010 amendment discussed
below. Under the Collaboration Agreement following the April 2010 amendment, the ongoing global research and development (R&D) costs for ACTONEL are shared equally between the parties, except for R&D costs specifically related to
the United States and Puerto Rico, which are borne solely by the Company. In certain geographic markets, the Company and Sanofi share selling and advertising and promotion (A&P) costs, as well as product profits based on contractual
percentages. In the geographic markets where the Company is deemed to be the principal in transactions with customers and invoices sales, the Company recognizes all revenues from sales of the product along with the related product costs. In these
markets, all selling and A&P expenses incurred by the Company and all contractual payments to Sanofi are recognized in SG&A expenses. In geographic markets where Sanofi is deemed to be the principal in transactions with customers and
invoices sales, the Companys share of selling and A&P expenses is recognized in SG&A expenses, and the Company recognizes its share of income attributable to the contractual payments made by Sanofi to the Company in these territories,
on a net basis, as a component of other revenue.
In April 2010, the Company and Sanofi entered into an amendment
to the Collaboration Agreement. Pursuant to the terms of the amendment, the Company took full operational control over the promotion, marketing and R&D decisions for ACTONEL and ATELVIA in the United States and Puerto Rico, and assumed
responsibility for all associated costs relating to those activities. Prior to the amendment, the Company shared such costs with Sanofi in these territories. The Company remained the principal in transactions with customers in the United States and
Puerto Rico and continues to invoice all sales in these territories. In return, it was agreed that for the remainder of the term of the Collaboration Agreement, Sanofi would receive, as part of the global collaboration agreement between the parties,
payments from the Company which, depending on actual net sales in the United States and Puerto Rico, are based on an agreed percentage of either United States and Puerto Rico actual net sales or an agreed minimum sales threshold for the territory.
As of June 30, 2013, the fixed minimum payments under the Collaboration Agreement relating to the United States and Puerto Rico totaled $125 million, all of which will be payable in the year ending December 31, 2014.
The Company will continue to sell ACTONEL and ATELVIA products with Sanofi in accordance with its obligations under the Collaboration
Agreement until the termination of the Collaboration Agreement on January 1, 2015, at which time all of Sanofis rights under the Collaboration Agreement will revert to the Company. Thereafter, the Company will have the sole right to
market and promote ACTONEL and ATELVIA on a global basis, excluding Japan.
For the quarters and six months ended
June 30, 2013 and 2012, the Company recognized net sales, other revenue and co-promotion expenses as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
(dollars in millions)
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
Net sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ACTONEL
|
|
$
|
84
|
|
|
$
|
134
|
|
|
$
|
183
|
|
|
$
|
265
|
|
ATELVIA
|
|
|
18
|
|
|
|
16
|
|
|
|
37
|
|
|
|
32
|
|
Other revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ACTONEL
|
|
|
12
|
|
|
|
16
|
|
|
|
24
|
|
|
|
31
|
|
Co-promotion expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ACTONEL / ATELVIA
|
|
|
50
|
|
|
|
60
|
|
|
|
100
|
|
|
|
120
|
|
11
9. Inventories
Inventories consisted of the following:
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
As of
June 30, 2013
|
|
|
As of
December 31, 2012
|
|
Finished goods
|
|
$
|
59
|
|
|
$
|
57
|
|
Work-in-progress / Bulk
|
|
|
29
|
|
|
|
26
|
|
Raw materials
|
|
|
38
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
126
|
|
|
$
|
113
|
|
|
|
|
|
|
|
|
|
|
Total inventories are net of $35 million and $22 million related to inventory obsolescence reserves as of
June 30, 2013 and December 31, 2012, respectively.
Product samples are stated at cost ($7 million and $8 million as
of June 30, 2013 and December 31, 2012, respectively) and are included in prepaid expenses and other current assets.
10. Goodwill and Intangible Assets
The Companys goodwill and a trademark have been deemed to have indefinite lives and are not amortized. The
Companys acquired intellectual property, licensing agreements and certain trademarks that do not have indefinite lives are being amortized on either an economic benefit model, which typically results in accelerated amortization, or on a
straight-line basis over their useful lives not to exceed 15 years.
The Companys intangible assets as of June 30,
2013 consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Gross Carrying
Value
|
|
|
Accumulated
Amortization
|
|
|
Net Carrying
Value
|
|
Definite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
ASACOL / DELZICOL product family
|
|
$
|
1,849
|
|
|
$
|
847
|
|
|
$
|
1,002
|
|
ENABLEX
|
|
|
506
|
|
|
|
299
|
|
|
|
207
|
|
ATELVIA
|
|
|
241
|
|
|
|
43
|
|
|
|
198
|
|
ACTONEL
|
|
|
525
|
|
|
|
450
|
|
|
|
75
|
|
ESTRACE Cream
|
|
|
411
|
|
|
|
358
|
|
|
|
53
|
|
Other products
|
|
|
1,485
|
|
|
|
1,453
|
|
|
|
32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total definite-lived intangible assets
|
|
|
5,017
|
|
|
|
3,450
|
|
|
|
1,567
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Trademark
|
|
|
30
|
|
|
|
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets, net
|
|
$
|
5,047
|
|
|
$
|
3,450
|
|
|
$
|
1,597
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys intangible assets as of December 31, 2012 consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Gross Carrying
Value
|
|
|
Accumulated
Amortization
|
|
|
Net Carrying
Value
|
|
Definite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
ASACOL / DELZICOL product family
|
|
$
|
1,849
|
|
|
$
|
742
|
|
|
$
|
1,107
|
|
ENABLEX
|
|
|
506
|
|
|
|
252
|
|
|
|
254
|
|
ATELVIA
|
|
|
241
|
|
|
|
31
|
|
|
|
210
|
|
ACTONEL
|
|
|
525
|
|
|
|
413
|
|
|
|
112
|
|
ESTRACE Cream
|
|
|
411
|
|
|
|
343
|
|
|
|
68
|
|
Other products
|
|
|
1,485
|
|
|
|
1,449
|
|
|
|
36
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total definite-lived intangible assets
|
|
|
5,017
|
|
|
|
3,230
|
|
|
|
1,787
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Trademark
|
|
|
30
|
|
|
|
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets, net
|
|
$
|
5,047
|
|
|
$
|
3,230
|
|
|
$
|
1,817
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate amortization expense related to intangible assets was $110 million and $124 million for the
quarters ended June 30, 2013 and 2012, respectively, and was $220 million and $254 million for the six months ended June 30, 2013 and 2012, respectively. The Company continuously reviews its products remaining useful lives based on
each products estimated future cash flows. The Company may incur material impairment charges or accelerate the amortization of certain intangible assets based on triggering events that reduce expected future cash flows, including those events
relating to the loss of market exclusivity for any of the Companys products as a result of the expiration of a patent, the expiration of U.S. Food and Drug Administration (FDA) exclusivity or an at-risk launch of a competing
generic product. Based on the Companys review of future cash flows, the Company recorded an impairment charge in the quarter ended June 30, 2012 of $106 million, $101 million of which was attributable to the impairment of the
Companys DORYX intangible asset following the April 30, 2012
12
decision of the U.S. District Court for the District of New Jersey holding that neither Mylan Pharmaceuticals Inc.s (Mylan) nor Impax Laboratories, Inc.s
(Impax) proposed generic version of the Companys DORYX 150 mg product (DORYX 150) infringed U.S. Patent No. 6,958,161 covering DORYX 150 (the 161 Patent) and Mylans subsequent introduction
of a generic product in early May 2012. For a discussion of the DORYX patent litigation and the Companys other ongoing patent litigation, refer to Note 15.
Estimated amortization expense based on current forecasts (excluding indefinite-lived intangible assets) for the period from July 1, 2013 to December 31, 2013 and for each of the next five years
is as follows:
|
|
|
|
|
(dollars in millions)
|
|
Amortization
|
|
|
|
2013 (remaining)
|
|
$
|
220
|
|
2014
|
|
|
369
|
|
2015
|
|
|
291
|
|
2016
|
|
|
185
|
|
2017
|
|
|
157
|
|
2018
|
|
|
130
|
|
Thereafter
|
|
|
215
|
|
|
|
|
|
|
|
|
$
|
1,567
|
|
|
|
|
|
|
11. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
As of
June 30, 2013
|
|
|
As of
December 31, 2012
|
|
Product rebate accruals (commercial and government)
|
|
$
|
237
|
|
|
$
|
269
|
|
Sales return reserves
|
|
|
124
|
|
|
|
118
|
|
Customer loyalty and coupon programs
|
|
|
46
|
|
|
|
47
|
|
Payroll, commissions, and employee costs
|
|
|
29
|
|
|
|
35
|
|
Interest payable
|
|
|
29
|
|
|
|
29
|
|
Professional fees
|
|
|
29
|
|
|
|
17
|
|
U.S. branded prescription drug fee
|
|
|
18
|
|
|
|
|
|
Severance accruals
(1)
|
|
|
15
|
|
|
|
31
|
|
R&D expense accruals
|
|
|
9
|
|
|
|
4
|
|
Litigation-related accruals
|
|
|
8
|
|
|
|
6
|
|
Obligations under product licensing and distribution agreements
|
|
|
8
|
|
|
|
10
|
|
Liabilities related to dividends declared
|
|
|
7
|
|
|
|
7
|
|
Deferred liabilities
|
|
|
3
|
|
|
|
3
|
|
Withholding taxes
|
|
|
2
|
|
|
|
12
|
|
ACTONEL co-promotion liability
|
|
|
|
|
|
|
49
|
|
Other
|
|
|
27
|
|
|
|
31
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
591
|
|
|
$
|
668
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Severance liabilities included as a component of other non-current liabilities totaled $1 million as of each of June 30, 2013 and December 31, 2012.
|
12. Indebtedness
Senior Secured Credit Facilities
On March 17, 2011, Warner Chilcott Holdings Company III, Limited (Holdings III), WC Luxco S.à r.l. (the Luxco Borrower), Warner Chilcott Corporation (WCC or
the US Borrower) and Warner Chilcott Company, LLC (WCCL or the PR Borrower, and together with the Luxco Borrower and the US Borrower, the Borrowers) entered into a new credit agreement (the
Credit Agreement) with a syndicate of lenders (the Lenders) and Bank of America, N.A. as administrative agent, in order to refinance the Companys then-outstanding senior secured credit facilities (the Prior Senior
Secured Credit Facilities). Pursuant to the Credit Agreement, the Lenders provided senior secured credit facilities (the Initial Senior Secured Credit Facilities) in an aggregate amount of $3,250 million comprised of
(i) $3,000 million in aggregate term loan facilities and (ii) a $250 million revolving credit facility available to all Borrowers (the Revolving Credit Facility). The term loan facilities were initially comprised of (i) a
$1,250 million Term A Loan Facility (the Term A Loan) and (ii) a $1,750 million Term B Loan Facility consisting of an $800 million Term B-1 Loan, a $400 million Term B-2 Loan and a $550 million Term B-3 Loan (together, the
Initial Term B Loans). The proceeds of these term loans, together with approximately $279 million of cash on hand, were used to make an optional prepayment of $250 million in aggregate term loans under the Prior Senior Secured Credit
Facilities, repay the remaining $2,969 million in aggregate term loans outstanding under the Prior Senior Secured Credit Facilities, terminate the Prior Senior Secured Credit Facilities and pay certain related fees, expenses and accrued interest.
13
On August 20, 2012, Holdings III and the Borrowers entered into an amendment to the
Credit Agreement, pursuant to which the Lenders provided additional term loans in an aggregate principal amount of $600 million (the Additional Term Loan Facilities and, together with the Initial Senior Secured Credit Facilities, the
Senior Secured Credit Facilities), which, together with cash on hand, were used to fund a special cash dividend in September 2012 of $4.00 per share, or $1,002 million in the aggregate (the 2012 Special Dividend), and to pay
related fees and expenses. The Additional Term Loan Facilities were comprised of (i) a $250 million Term B-4 Loan Facility and a $50 million Term B-5 Loan Facility (collectively, the Term B-4/5 Loan) and (ii) a $300 million
Additional Term B-1 Loan Facility (the Additional Term B-1 Loan).
The Term A Loan matures on March 17, 2016
and bears interest at LIBOR plus 3.00%, with a LIBOR floor of 0.75%, each of the Initial Term B Loans and the Additional Term B-1 Loan matures on March 15, 2018 and bears interest at LIBOR plus 3.25%, with a LIBOR floor of 1.00%, and the Term
B-4/5 Loan matures on August 20, 2017 and bears interest at LIBOR plus 3.00%, with no LIBOR floor. The Revolving Credit Facility matures on March 17, 2016 and includes a $20 million sublimit for swing line loans and a $50 million sublimit
for the issuance of standby letters of credit. Any swing line loans and letters of credit would reduce the available commitment under the Revolving Credit Facility on a dollar-for-dollar basis. Loans drawn under the Revolving Credit Facility bear
interest at LIBOR plus 3.00%, and letters of credit issued under the Revolving Credit Facility are subject to a fee equal to 3.00% per annum on the amounts thereof. The Borrowers are also required to pay a commitment fee on the unused
commitments under the Revolving Credit Facility at a rate of 0.75% per annum, subject to leverage-based step-downs.
The
loans and other obligations under the Senior Secured Credit Facilities (including in respect of hedging agreements and cash management obligations) are (i) guaranteed by Holdings III and substantially all of its subsidiaries (subject to certain
exceptions and limitations) and (ii) secured by substantially all of the assets of the Borrowers and each guarantor (subject to certain exceptions and limitations). In addition, the Senior Secured Credit Facilities contain (i) customary
provisions related to mandatory prepayment of the loans thereunder with (a) 50% of excess cash flow, as defined, subject to a leverage-based step-down and (b) the proceeds of asset sales or casualty events (subject to certain limitations,
exceptions and reinvestment rights) and the incurrence of certain additional indebtedness and (ii) certain covenants that, among other things, restrict additional indebtedness, liens and encumbrances, loans and investments, acquisitions,
dividends and other restricted payments, transactions with affiliates, asset dispositions, mergers and consolidations, prepayments, redemptions and repurchases of other indebtedness and other matters customarily restricted in such agreements and, in
each case, subject to certain exceptions.
The Senior Secured Credit Facilities specify certain customary events of default
including, without limitation, non-payment of principal or interest, violation of covenants, breaches of representations and warranties in any material respect, cross default or cross acceleration of other material indebtedness, material judgments
and liabilities, certain Employee Retirement Income Security Act events and invalidity of guarantees and security documents under the Senior Secured Credit Facilities.
The fair value as of June 30, 2013 and December 31, 2012 of the Companys debt outstanding under its Senior Secured Credit Facilities, as determined in accordance with ASC Topic 820
Fair Value Measurements and Disclosures (ASC 820) under Level 2 based upon quoted prices for similar items in active markets, was approximately $2,233 million ($2,233 million book value) and $2,744 million ($2,718 million
book value), respectively.
As of June 30, 2013, there were letters of credit totaling $2 million outstanding. As a
result, the Company had $248 million available under the Revolving Credit Facility as of June 30, 2013. During the quarter and six months ended June 30, 2013, the Company made optional prepayments of $150 million and $400 million,
respectively, of its term loan indebtedness under the Senior Secured Credit Facilities.
7.75% Notes
On August 20, 2010, the Company and certain of the Companys subsidiaries entered into an indenture (the Indenture)
with Wells Fargo Bank, National Association, as trustee, in connection with the issuance by WCCL and Warner Chilcott Finance LLC (together, the Issuers) of $750 million aggregate principal amount of 7.75% senior notes due 2018 (the
7.75% Notes). The 7.75% Notes are unsecured senior obligations of the Issuers, guaranteed on a senior basis by the Company and its subsidiaries that guarantee obligations under the Senior Secured Credit Facilities, subject to certain
exceptions. The 7.75% Notes will mature on September 15, 2018. Interest on the 7.75% Notes is payable on March 15 and September 15 of each year, and the first payment was made on March 15, 2011.
On September 29, 2010, the Issuers issued an additional $500 million aggregate principal amount of 7.75% Notes at a premium of $10
million. The proceeds from the issuance of the additional 7.75% Notes were used by the Company to fund its $400 million upfront payment in connection with the ENABLEX Acquisition, which closed on October 18, 2010, and for general corporate
purposes. The additional 7.75% Notes constitute a part of the same series, and have the same guarantors, as the 7.75% Notes issued in August 2010. The $10 million premium received was added to the face value of the 7.75% Notes and is being amortized
over the life of the 7.75% Notes as a reduction to reported interest expense.
14
The Indenture contains restrictive covenants that limit, among other things, the ability of
each of Holdings III, and certain of Holdings IIIs subsidiaries, to incur additional indebtedness, pay dividends and make distributions on common and preferred stock, repurchase subordinated debt and common and preferred stock, make other
restricted payments, make investments, sell certain assets, incur liens, consolidate, merge, sell or otherwise dispose of all or substantially all of its assets and enter into certain transactions with affiliates. The Indenture also contains
customary events of default which would permit the holders of the 7.75% Notes to declare those 7.75% Notes to be immediately due and payable if not cured within applicable grace periods, including the failure to make timely payments on the 7.75%
Notes or other material indebtedness, the failure to comply with covenants, and specified events of bankruptcy and insolvency.
The fair value of the Companys outstanding 7.75% Notes ($1,250 million book value), as determined in accordance with ASC 820 under
Level 2 based upon quoted prices for similar items in active markets, was $1,350 million and $1,325 million as of June 30, 2013 and December 31, 2012, respectively.
Components of Indebtedness
As of June 30, 2013, the
Companys outstanding debt included the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Current Portion
as of
June 30, 2013
|
|
|
Long-Term
Portion as of
June 30, 2013
|
|
|
Total Outstanding
as of
June 30, 2013
|
|
Revolving Credit Facility under the Senior Secured Credit Facilities
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Term loans under the Senior Secured Credit Facilities
|
|
|
189
|
|
|
|
2,044
|
|
|
|
2,233
|
|
7.75% Notes (including $7 unamortized premium)
|
|
|
1
|
|
|
|
1,256
|
|
|
|
1,257
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
190
|
|
|
$
|
3,300
|
|
|
$
|
3,490
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2013, scheduled mandatory principal repayments of long-term debt for the period from
July 1, 2013 to December 31, 2013 and in each of the five years ending December 31, 2014 through 2018 were as follows:
|
|
|
|
|
(dollars in millions)
Year Ending December 31,
|
|
Aggregate
Maturities
|
|
2013 (remaining)
|
|
$
|
91
|
|
2014
|
|
|
197
|
|
2015
|
|
|
242
|
|
2016
|
|
|
87
|
|
2017
|
|
|
84
|
|
2018
|
|
|
2,782
|
|
|
|
|
|
|
Total long-term debt to be settled in cash
|
|
$
|
3,483
|
|
7.75% Notes unamortized premium
|
|
|
7
|
|
|
|
|
|
|
Total long-term debt
|
|
$
|
3,490
|
|
|
|
|
|
|
13. Stock-Based Compensation Plans
The Companys stock-based compensation, including grants of non-qualified time-based vesting options to purchase
ordinary shares and grants of time-based and performance-based vesting restricted ordinary shares/share units, is measured at fair value on the date of grant and is recognized in the statement of operations as compensation expense over the
applicable vesting periods. For purposes of computing the amount of stock-based compensation attributable to time-based vesting options and time-based vesting restricted ordinary shares/share units expensed in any period, the Company treats such
equity grants as serial grants with separate vesting dates. This treatment results in accelerated recognition of share-based compensation expense whereby 52% of the compensation is recognized in year one, 27% is recognized in year two, 15% is
recognized in year three, and 6% is recognized in the final year of vesting. The Company treats performance-based vesting restricted ordinary share/share unit grants as vesting evenly over a four year vesting period, subject to the achievement of
annual performance targets.
Total stock-based compensation expense recognized for the quarters ended June 30, 2013 and
2012 was $7 million and $6 million, respectively, and for the six months ended June 30, 2013 and 2012 was $13 million and $12 million, respectively. Unrecognized future stock-based compensation expense was $38 million as of June 30, 2013.
This amount will be recognized as an expense over a remaining weighted average period of 1.2 years.
15
The Company has granted equity-based incentives to its employees comprised of restricted
ordinary shares/share units and non-qualified options to purchase ordinary shares. All restricted ordinary shares/share units (whether time-based vesting or performance-based vesting) are granted and expensed, using the closing market price per
share on the applicable grant date, over a four year vesting period. Non-qualified options to purchase ordinary shares are granted to employees at exercise prices per share equal to the closing market price per share on the date of grant.
The fair value of non-qualified options is determined on the applicable grant date using the Black-Scholes method of
valuation and that amount is recognized as an expense over the four year vesting period. In establishing the value of the options on each grant date, the Company uses its actual historical volatility for its ordinary shares to estimate the expected
volatility at each grant date. Beginning in September 2012, the dividend yield is calculated on the day of grant using the annual expected dividend under the Dividend Policy of $0.50 per share divided by the closing stock price on that given day.
The options have a term of ten years. The Company assumes that the options will be exercised, on average, in six years. Using the Black-Scholes valuation model, the fair value of the options is based on the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months ended
June 30, 2013
|
|
|
Year ended
December 31, 2012
|
|
Dividend yield
|
|
|
3.34 - 3.49
|
%
|
|
|
0 - 4.15
|
%
|
Expected volatility
|
|
|
40.00
|
%
|
|
|
38.00 - 40.00
|
%
|
Risk-free interest rate
|
|
|
1.78 - 2.02
|
%
|
|
|
1.76 - 1.87
|
%
|
Expected term (years)
|
|
|
6.00
|
|
|
|
6.00
|
|
The weighted average remaining contractual term of all outstanding options to purchase ordinary shares
granted was 7 years as of June 30, 2013.
The following is a summary of equity award activity for unvested restricted
ordinary shares/share units in the period from December 31, 2012 through June 30, 2013:
|
|
|
|
|
|
|
|
|
|
|
Restricted Share/Share Unit Grants
|
|
(in millions except per share amounts)
|
|
Shares/Share
Units
|
|
|
Weighted
Average Fair
Value per share
on Grant
Date
|
|
Unvested restricted ordinary shares/share units, at December 31, 2012
|
|
|
2.5
|
|
|
$
|
19.03
|
|
Granted share units
|
|
|
2.1
|
|
|
|
14.18
|
|
Vested shares/share units
|
|
|
(0.8
|
)
|
|
|
19.29
|
|
Forfeited shares/share units
|
|
|
(0.3
|
)
|
|
|
16.10
|
|
|
|
|
|
|
|
|
|
|
Unvested restricted ordinary shares/share units, at June 30, 2013
|
|
|
3.5
|
|
|
$
|
16.30
|
|
|
|
|
|
|
|
|
|
|
The following is a summary of equity award activity for non-qualified options to purchase ordinary shares
in the period from December 31, 2012 through June 30, 2013:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options to Purchase Ordinary Shares
|
|
(in millions except per option amounts)
|
|
Options
|
|
|
Weighted
Average Fair
Value per Option
on Grant
Date
|
|
|
Weighted
Average
Exercise
Price per
Option
|
|
Balance at December 31, 2012
|
|
|
5.8
|
|
|
$
|
6.29
|
|
|
$
|
10.50
|
|
Granted options
|
|
|
1.2
|
|
|
|
4.06
|
|
|
|
14.34
|
|
Exercised options
|
|
|
(0.6
|
)
|
|
|
6.58
|
|
|
|
5.33
|
|
Forfeited options
|
|
|
(0.2
|
)
|
|
|
6.90
|
|
|
|
14.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2013
|
|
|
6.2
|
|
|
$
|
5.79
|
|
|
$
|
11.59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable at June 30, 2013
|
|
|
4.0
|
|
|
$
|
5.67
|
|
|
$
|
9.78
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
The intrinsic value of non-qualified options to purchase ordinary shares is calculated as
the difference between the closing price of the Companys ordinary shares and the exercise price of the non-qualified options to purchase ordinary shares that had a strike price below the closing price. The total intrinsic value for the
non-qualified options to purchase ordinary shares that are in-the-money as of June 30, 2013 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in millions except per option and per share amounts)
|
|
Number of
Options
|
|
|
Weighted
Average
Exercise
Price per
Option
|
|
|
Closing
Stock
Price per
Share
|
|
|
Total
Intrinsic
Value
|
|
Balance outstanding at June 30, 2013
|
|
|
5.7
|
|
|
$
|
10.82
|
|
|
$
|
19.91
|
|
|
$
|
52
|
|
Vested and exercisable at June 30, 2013
|
|
|
3.7
|
|
|
$
|
8.97
|
|
|
$
|
19.91
|
|
|
$
|
40
|
|
14. Commitments and Contingencies
Product Development Agreements
In July 2007, the Company entered into an agreement with Paratek Pharmaceuticals Inc. (Paratek) under which it acquired certain rights to novel tetracyclines under development for the
treatment of acne and rosacea. The Company paid an up-front fee of $4 million and agreed to reimburse Paratek for R&D expenses incurred during the term of the agreement. In September 2010, the Company made a $1 million milestone payment to
Paratek upon the achievement of a developmental milestone. In June 2012, the Company made a $2 million milestone payment to Paratek upon the achievement of a developmental milestone, which was included in R&D expenses in the quarter and six
months ended June 30, 2012. The Company may make additional payments to Paratek upon the achievement of certain developmental milestones that could aggregate up to $21 million. In addition, the Company agreed to pay royalties to Paratek based
on the net sales, if any, of the products covered under the agreement.
In December 2008, the Company signed an agreement (the
Dong-A Agreement) with Dong-A PharmTech Co. Ltd. (Dong-A), to develop and, if approved, market its orally-administered udenafil product, a PDE5 inhibitor for the treatment of erectile dysfunction (ED) in the
United States. The Company paid $2 million in connection with signing the Dong-A Agreement. In March 2009, the Company paid $9 million to Dong-A upon the achievement of a developmental milestone related to the ED product under the Dong-A Agreement.
The Company agreed to pay for all development costs incurred during the term of the Dong-A Agreement with respect to development of the ED product to be marketed in the United States, and the Company may make additional payments to Dong-A of up to
$13 million upon the achievement of contractually-defined milestones in relation to the ED product. In addition, the Company agreed to pay a profit-split to Dong-A based on operating profit (as defined in the Dong-A Agreement), if any, resulting
from the commercial sale of the ED product.
In February 2009, the Company acquired the U.S. rights to Apricus
Biosciences, Inc.s (formerly NexMed, Inc.) (Apricus) topically applied alprostadil cream for the treatment of ED and a prior license agreement between the Company and Apricus relating to the product was terminated. Under the terms
of the acquisition agreement, the Company paid Apricus an up-front payment of $3 million. The Company also agreed to make a milestone payment of $2 million upon the FDAs approval of the products New Drug Application. The Company
continues to work to prepare its response to the non-approvable letter that the FDA delivered to Apricus in July 2008 with respect to the product.
In April 2010, the Company amended the Dong-A Agreement to add the right to develop, and if approved, market in the United States and Canada, Dong-As udenafil product for the treatment of lower
urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH). As a result of this amendment, the Company made an up-front payment to Dong-A of $20 million in April 2010. Under the amendment, the Company may make additional
payments to Dong-A in an aggregate amount of up to $25 million upon the achievement of contractually-defined milestones in relation to the BPH product. These payments would be in addition to the potential milestone payments in relation to the ED
product described above. The Company also agreed to pay Dong-A a percentage of net sales of the BPH product in the United States and Canada, if any.
The Company and Sanofi are parties to the Collaboration Agreement pursuant to which they co-develop and market ACTONEL on a global basis, excluding Japan. ATELVIA, the Companys risedronate sodium
delayed-release product launched in January 2011 and currently sold in the United States and Canada, is also marketed pursuant to the Collaboration Agreement. See Note 8 for additional information related to the Collaboration Agreement.
Other Commitments and Contingencies
In March 2012, the Companys Fajardo, Puerto Rico manufacturing facility received a warning letter from the FDA. The warning letter raised certain violations of current Good Manufacturing Practices
originally identified in a Form 483 observation letter issued by the FDA after an inspection of the Companys Fajardo facility in June and July 2011. More specifically, the warning letter indicated that the Company failed to conduct a
comprehensive evaluation of its corrective actions to ensure that certain stability issues concerning OVCON 50 were adequately addressed. In addition, the FDA cited the Companys stability issues with OVCON 50 and the Companys evaluation
of certain other quality data, in expressing its general concerns with respect to the performance of the Companys Fajardo quality control unit.
17
The Company takes these matters seriously and submitted a written response to the FDA in
April 2012. Following its receipt of the Form 483 observation letter, the Company immediately initiated efforts to address the issues identified by the FDA. In March and April 2013, the FDA re-inspected the Fajardo facility and issued a Form 483
observation letter at the conclusion thereof that identified two observations, which did not directly relate to the issues listed in the warning letter. The Company provided its response to such observations to the FDA in early May 2013. In June
2013, the FDA issued the Company a warning letter close out letter, informing the Company that it had addressed the issues raised by the FDA in the warning letter.
15. Legal Proceedings
General Matters
The Company is involved in various legal proceedings, including product liability litigation, intellectual property litigation, antitrust litigation, false claims act litigation, employment litigation and
other litigation, as well as government investigations. The outcome of such proceedings is uncertain, and the Company may from time to time enter into settlements to resolve such proceedings that could result, among other things, in the sale of
generic versions of the Companys products prior to the expiration of its patents.
The Company records reserves related
to legal matters when losses related to such litigation or contingencies are both probable and reasonably estimable. The Company maintains insurance with respect to potential litigation in the normal course of its business based on its consultation
with its insurance consultants and outside legal counsel, and in light of current market conditions, including cost and availability. The Company is responsible for any losses from such litigation that are not covered under its litigation insurance.
The following discussion is limited to the Companys material on-going legal proceedings:
Product Liability Litigation
Hormone Therapy Product Liability Litigation
Approximately 721 product liability suits, including some with multiple plaintiffs, have been filed against, or tendered to, the Company related to its hormone therapy (HT) products, FEMHRT,
ESTRACE, ESTRACE Cream and medroxyprogesterone acetate. Under the purchase and sale agreement pursuant to which the Company acquired FEMHRT from Pfizer Inc. (Pfizer) in 2003, the Company agreed to assume certain product liability
exposure with respect to claims made against Pfizer after March 5, 2003 and tendered to the Company relating to FEMHRT products. The cases are in the early stages of litigation and the Company is in the process of analyzing and investigating
the individual complaints.
The lawsuits were likely triggered by the July 2002 and March 2004
announcements by the National Institute of Health (NIH) of the terminations of two large-scale randomized controlled clinical trials, which were part of the Womens Health Initiative (WHI), examining the long-term effect
of HT on the prevention of coronary heart disease and osteoporotic fractures, and any associated risk for breast cancer in postmenopausal women. In the case of the trial terminated in 2002, which examined combined estrogen and progestogen therapy
(the E&P Arm of the WHI Study), the safety monitoring board determined that the risks of long-term estrogen and progestogen therapy exceeded the benefits, when compared to a placebo. WHI investigators found that combined estrogen and
progestogen therapy did not prevent heart disease in the study subjects and, despite a decrease in the incidence of hip fracture and colorectal cancer, there was an increased risk of invasive breast cancer, coronary heart disease, stroke, blood
clots and dementia. In the trial terminated in 2004, which examined estrogen therapy, the trial was ended one year early because the NIH did not believe that the results were likely to change in the time remaining in the trial and that the increased
risk of stroke could not be justified for the additional data that could be collected in the remaining time. As in the E&P Arm of the WHI Study, WHI investigators again found that estrogen only therapy did not prevent heart disease and, although
study subjects experienced fewer hip fractures and no increase in the incidence of breast cancer compared to subjects randomized to placebo, there was an increased incidence of stroke and blood clots in the legs. The estrogen used in the WHI study
was conjugated equine estrogen and the progestin was medroxyprogesterone acetate, the compounds found in
Premarin
®
and Prempro
®
, products marketed by Wyeth (now a part of Pfizer). Numerous lawsuits were filed against Wyeth, as well as against other manufacturers of HT products, after the
publication of the summary of the principal results of the E&P Arm of the WHI Study.
Approximately 80% of the complaints
filed against, or tendered to, the Company did not specify the HT drug alleged to have caused the plaintiffs injuries. These complaints broadly allege that the plaintiff suffered injury as a result of an HT product. The Company has sought the
dismissal of lawsuits that, after further investigation, do not involve any of its products. The Company has successfully reduced the number of HT suits it will have to defend. Of the approximately 721 suits that were filed against, or tendered to,
the Company, 564 have been dismissed and 94 involving ESTRACE have been successfully tendered to Bristol-Myers Squibb Company (Bristol-Myers) pursuant to an indemnification provision in the asset purchase agreement pursuant to which the
Company acquired ESTRACE. The purchase agreement included an indemnification agreement whereby Bristol-Myers indemnified the Company for product liability exposure associated with ESTRACE products that were shipped prior to July 2001. Although it is
impossible to predict with certainty the outcome of any litigation, an unfavorable outcome in these proceedings is not anticipated. An estimate of the potential loss, or range of loss, if any, to the Company relating to these proceedings is not
possible at this time.
18
ACTONEL Product Liability Litigation
The Company is a defendant in approximately 264 cases and a potential defendant with respect to approximately 380 unfiled claims involving
a total of approximately 652 plaintiffs and potential plaintiffs relating to the Companys bisphosphonate prescription drug ACTONEL. The claimants allege, among other things, that ACTONEL caused them to suffer osteonecrosis of the jaw
(ONJ), a rare but serious condition that involves severe loss or destruction of the jawbone, and/or atypical fractures of the femur (AFF). All of the cases have been filed in either federal or state courts in the United
States. The Company is in the initial stages of discovery in these litigations. The 380 unfiled claims involve potential plaintiffs that have agreed, pursuant to a tolling agreement, to postpone the filing of their claims against the Company in
exchange for the Companys agreement to suspend the statutes of limitations relating to their potential claims. In addition, the Company is aware of four purported product liability class actions that were brought against the
Company in provincial courts in Canada alleging, among other things, that ACTONEL caused the plaintiffs and the proposed class members who ingested ACTONEL to suffer atypical fractures or other side effects. It is expected that these
plaintiffs will seek class certification. Of the approximately 656 total ACTONEL-related claims, approximately 157 include ONJ-related claims, approximately 481 include AFF-related claims and approximately 4 include both ONJ and
AFF-related claims. The Company is reviewing these lawsuits and potential claims and intends to defend these claims vigorously.
Sanofi, which co-promotes ACTONEL with the Company on a global basis pursuant to the Collaboration Agreement, is a defendant in many of
the Companys ACTONEL product liability cases. In some of the cases, manufacturers of other bisphosphonate products are also named as defendants. Plaintiffs have typically asked for unspecified monetary and injunctive relief, as well as
attorneys fees. Under the Collaboration Agreement, Sanofi has agreed to indemnify the Company, subject to certain limitations, for 50% of the losses from any product liability claims in Canada relating to ACTONEL and for 50% of the losses from
any product liability claims in the United States and Puerto Rico relating to ACTONEL brought prior to April 1, 2010, which would include approximately 90 claims relating to ONJ and other alleged injuries that were pending as of March 31,
2010 and not subsequently dismissed. Pursuant to the April 2010 amendment to the Collaboration Agreement, the Company will be fully responsible for any product liability claims in the United States and Puerto Rico relating to ACTONEL brought on or
after April 1, 2010. The Company may be liable for product liability, warranty or similar claims in relation to products acquired from The Procter & Gamble Company (P&G) in October 2009 in connection with the
Companys acquisition (the PGP Acquisition) of P&Gs global branded pharmaceuticals business (PGP), including ONJ-related claims that were pending as of the closing of the PGP Acquisition. The
Companys agreement with P&G provides that P&G will indemnify the Company, subject to certain limits, for 50% of the Companys losses from any such claims, including approximately 88 claims relating to ONJ and other alleged
injuries, pending as of October 30, 2009 and not subsequently dismissed.
The Company currently maintains product
liability insurance coverage for claims aggregating between $30 million and $170 million, subject to certain terms, conditions and exclusions, and is otherwise responsible for any losses from such claims. The terms of the Companys current and
prior insurance programs vary from year to year and the Companys insurance may not apply to, among other things, damages or defense costs related to the above mentioned HT or ACTONEL-related claims, including any claim arising out of HT or
ACTONEL products with labeling that does not conform completely to FDA approved labeling.
In May 2013, the Company entered
into a settlement agreement in respect of up to 74 ONJ-related claims, subject to the acceptance thereof by the individual respective claimants. The Company recorded a charge in the six months ended June 30, 2013 in the amount of $2 million in
accordance with ASC Topic 450 Contingencies in connection with the Companys entry into the settlement agreement. This charge represents the Companys current estimate of the aggregate amount that is probable to be paid by the
Company in connection with the settlement agreement. Assuming that all of the relevant claimants accept the settlement agreement, approximately 582 ACTONEL-related claims would remain outstanding, of which approximately 83 include ONJ-related
claims, approximately 481 include AFF-related claims and approximately 4 include both ONJ and AFF-related claims. However, it is impossible to predict with certainty (i) the number of such individual claimants that will accept the settlement
agreement or (ii) the outcome of any litigation with claimants rejecting the settlement or other plaintiffs and potential plaintiffs with ONJ, AFF or other ACTONEL-related claims, and the Company can offer no assurance as to the likelihood of
an unfavorable outcome in any of these matters. An estimate of the potential loss, or range of loss, if any, to the Company relating to proceedings with (i) claimants rejecting the settlement or (ii) other plaintiffs and potential
plaintiffs with ONJ, AFF or other ACTONEL-related claims is not possible at this time.
Gastroenterology Patent Matters
ASACOL HD
In
September 2011, the Company received a Paragraph IV certification notice letter from Zydus Pharmaceuticals USA, Inc. (together with its affiliates, Zydus) indicating that Zydus had submitted to the FDA an Abbreviated New Drug Application
(ANDA) seeking approval to manufacture and sell a generic version of the Companys ASACOL 800 mg product (ASACOL HD). Zydus contends that the Companys U.S. Patent No. 6,893,662, expiring in November 2021 (the
662 Patent), is invalid and/or not infringed. In addition, Zydus indicated that it had submitted a Paragraph III certification with respect to Medeva Pharma Suisse AGs (Medeva) U.S. Patent No. 5,541,170 (the
170 Patent) and U.S. Patent No. 5,541,171 (the 171 Patent), formulation and method patents which the Company exclusively licenses from Medeva covering the Companys ASACOL products, consenting to the
delay of FDA approval of the ANDA product until the 170 Patent and the 171 Patent expire in July 2013. In November 2011, the Company filed a lawsuit against Zydus in the U.S. District Court for the District of Delaware
19
charging Zydus with infringement of the 662 Patent. The lawsuit results in a stay of FDA approval of Zydus ANDA for 30 months from the date of the Companys receipt of the Zydus
notice letter, subject to prior resolution of the matter before the court. While the Company intends to vigorously defend the 662 Patent and pursue its legal rights, the Company can offer no assurance as to when the pending litigation will be
decided, whether the lawsuit will be successful or that a generic equivalent of ASACOL HD will not be approved and enter the market prior to the expiration of the 662 Patent in 2021.
Osteoporosis Patent Matters
ACTONEL
ACTONEL Once-a-Week
In
July 2004, PGP received a Paragraph IV certification notice letter from a subsidiary of Teva Pharmaceutical Industries, Ltd. (together with its subsidiaries Teva) indicating that Teva had submitted to the FDA an ANDA seeking approval to
manufacture and sell a generic version of PGPs ACTONEL 35 mg product (ACTONEL OaW) . The notice letter contended that PGPs U.S. Patent No. 5,583,122 (the 122 Patent), a new chemical entity patent
expiring in June 2014 (including a 6-month pediatric extension of regulatory exclusivity), was invalid, unenforceable or not infringed. In August 2004, PGP filed a patent lawsuit against Teva in the U.S. District Court for the District of Delaware
charging Teva with infringement of the 122 Patent. In January 2006, Teva admitted patent infringement but alleged that the 122 Patent was invalid and, in February 2008, the District Court decided in favor of PGP and upheld the 122
Patent as valid and enforceable. In May 2009, the U.S. Court of Appeals for the Federal Circuit unanimously upheld the decision of the District Court.
Teva has received final approval from the FDA for its generic version of ACTONEL OaW and could enter the market as early as June 2014, following the expiration of the 122 Patent (including a 6-month
pediatric extension of regulatory exclusivity). In addition, several other companies have submitted ANDAs to the FDA seeking approval to manufacture and sell generic versions of ACTONEL OaW, including Aurobindo Pharma Limited
(Aurobindo), Mylan and Sun Pharma Global, Inc. (Sun). None of these additional ANDA filers challenged the validity of the 122 Patent, and as a result, the Company does not believe that any of the ANDA filers will be
permitted to market their proposed generic versions of ACTONEL OaW prior to the expiration of the patent in June 2014 (including a 6-month pediatric extension of regulatory exclusivity). However, if any of these ANDA filers receive final approval
from the FDA with respect to their ANDAs, such filers could also enter the market with a generic version of ACTONEL OaW following the expiration of the 122 Patent.
ACTONEL Once-a-Month
In August 2008, December 2008 and January 2009,
PGP and Hoffman-La Roche Inc. (Roche) received Paragraph IV certification notice letters from Teva, Sun and Apotex Inc. and Apotex Corp. (together Apotex), indicating that each such company had submitted to the FDA an ANDA
seeking approval to manufacture and sell generic versions of the ACTONEL 150 mg product (ACTONEL OaM). The notice letters contended that Roches U.S. Patent No. 7,192,938 (the 938 Patent), a method patent
expiring in November 2023 (including a 6-month pediatric extension of regulatory exclusivity) which Roche licensed to PGP with respect to ACTONEL OaM, was invalid, unenforceable or not infringed. PGP and Roche filed patent infringement suits against
Teva in September 2008, Sun in January 2009 and Apotex in March 2009 in the U.S. District Court for the District of Delaware charging each with infringement of the 938 Patent. The lawsuits resulted in a stay of FDA approval of each
defendants ANDA for 30 months from the date of PGPs and Roches receipt of notice, subject to the prior resolution of the matters before the court. The stay of approval of each of Tevas, Suns and Apotexs ANDAs has
expired, and the FDA has tentatively approved Tevas ANDA with respect to ACTONEL OaM. However, none of the defendants challenged the validity of the underlying 122 Patent, which covers all of the Companys ACTONEL products,
including ACTONEL OaM, and does not expire until June 2014 (including a 6-month pediatric extension of regulatory exclusivity). As a result, the Company does not believe that any of the defendants will be permitted to market their proposed generic
versions of ACTONEL OaM prior to June 2014.
On February 24, 2010, the Company and Roche received a Paragraph IV
certification notice letter from Mylan indicating that it had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of ACTONEL OaM. The notice letter contends that the 938 Patent, which expires in November
2023 and covers ACTONEL OaM, is invalid and/or will not be infringed. The Company and Roche filed a patent suit against Mylan in April 2010 in the U.S. District Court for the District of Delaware charging Mylan with infringement of the 938
Patent based on its proposed generic version of ACTONEL OaM. The lawsuit resulted in a stay of FDA approval of Mylans ANDA for 30 months from the date of the Companys and Roches receipt of notice, subject to prior resolution of the
matter before the court. The stay of approval of Mylans ANDA has now expired. Since Mylan did not challenge the validity of the underlying 122 Patent, which expires in June 2014 (including a 6-month pediatric extension of regulatory
exclusivity) and covers all of the Companys ACTONEL products, the Company does not believe that Mylan will be permitted to market its proposed ANDA product prior to the June 2014 expiration of the 122 Patent (including a 6-month
pediatric extension of regulatory exclusivity).
In October, November and December 2010 and February 2011, the Company and
Roche received Paragraph IV certification notice letters from Sun, Apotex, Teva and Mylan, respectively, indicating that each such company had amended its existing ANDA
20
covering generic versions of ACTONEL OaM to include a Paragraph IV certification with respect to Roches U.S. Patent No. 7,718,634 (the 634 Patent). The notice letters
contended that the 634 Patent, a method patent expiring in November 2023 (including a 6-month pediatric extension of regulatory exclusivity) which Roche licensed to the Company with respect to ACTONEL OaM, was invalid, unenforceable or not
infringed. The Company and Roche filed patent infringement suits against Sun and Apotex in December 2010, against Teva in January 2011 and against Mylan in March 2011 in the U.S. District Court for the District of Delaware charging each with
infringement of the 634 Patent. The Company believes that no additional 30-month stay is available in these matters because the 634 Patent was listed in the FDAs Orange Book subsequent to the date on which Sun, Apotex, Teva and
Mylan filed their respective ANDAs with respect to ACTONEL OaM. However, the underlying 122 Patent, which covers all of the Companys ACTONEL products, including ACTONEL OaM, does not expire until June 2014 (including a 6-month pediatric
extension of regulatory exclusivity).
The Company and Roches actions against Teva, Apotex, Sun and
Mylan for infringement of the 938 Patent and the 634 Patent arising from each such partys proposed generic version of ACTONEL OaM were consolidated for all pretrial purposes, and a consolidated trial for those suits was
previously expected to be held in July 2012. Following an adverse ruling in Roches separate ongoing patent infringement suit before the U.S. District Court for the District of New Jersey relating to its Boniva
®
product, in which the court held that claims of the 634 Patent covering a monthly dosing regimen using
ibandronate were invalid as obvious, Teva, Apotex, Sun and Mylan filed a motion for summary judgment in the Companys ACTONEL OaM patent infringement litigation. In the motion, the defendants have sought to invalidate the asserted claims of the
938 Patent and 634 Patent, which cover a monthly dosing regimen using risedronate, on similar grounds. The previously scheduled trial has been postponed pending resolution of the new summary judgment motion. A hearing on Teva,
Apotex, Sun and Mylans motions for summary judgment of invalidity and a separate motion by the Company and Roche for summary judgment of infringement took place on December 14, 2012.
To the extent that any ANDA filer also submitted a Paragraph IV certification with respect to U.S. Patent No. 6,165,513 covering
ACTONEL OaM, the Company has determined not to pursue an infringement action with respect to this patent. While the Company and Roche intend to vigorously defend the 938 Patent and the 634 Patent and protect their legal rights, the
Company can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful or that a generic equivalent of ACTONEL OaM will not be approved and enter the market prior to the expiration of the 938 Patent and
the 634 Patent in 2023 (including, in each case, a 6-month pediatric extension of regulatory exclusivity).
ATELVIA
In August and October 2011 and March 2012, the Company received Paragraph IV certification notice letters from
Watson Laboratories, Inc.Florida (together with Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.) and its subsidiaries, Actavis), Teva and Ranbaxy Laboratories Ltd. (together with its affiliates, Ranbaxy) indicating
that each had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of ATELVIA 35 mg tablets (ATELVIA). The notice letters contend that the Companys U.S. Patent Nos. 7,645,459 (the
459 Patent) and 7,645,460 (the 460 Patent), two formulation and method patents expiring in January 2028, are invalid, unenforceable and/or not infringed. The Company filed a lawsuit against Actavis in
October 2011, against Teva in November 2011 and against Ranbaxy in April 2012 in the U.S. District Court for the District of New Jersey charging each with infringement of the 459 Patent and 460 Patent. On August 21, 2012, the United
States Patent and Trademark Office issued to the Company U.S. Patent No. 8,246,989 (the 989 Patent), a formulation patent expiring in January 2026. The Company listed the 989 Patent in the FDAs Orange Book, each of
Actavis, Teva and Ranbaxy amended its Paragraph IV certification notice letter to contend that the 989 Patent is invalid and/or not infringed, and the Company amended its complaints against Actavis, Teva and Ranbaxy to assert the
989 Patent. The lawsuits result in a stay of FDA approval of each defendants ANDA for 30 months from the date of the Companys receipt of such defendants original notice letter, subject to prior resolution of the matter before
the court. The Company does not believe that the amendment of its complaints against Actavis, Teva and Ranbaxy to assert the 989 Patent will result in any additional 30-month stay. In addition, none of the ANDA filers certified against the
122 Patent, which covers all of the Companys ACTONEL and ATELVIA products and expires in June 2014 (including a 6-month pediatric extension of regulatory exclusivity).
While the Company intends to vigorously defend the 459 Patent, the 460 Patent and the 989 Patent and pursue its legal
rights, the Company can offer no assurance as to when the lawsuits will be decided, whether such lawsuits will be successful or that a generic equivalent of ATELVIA will not be approved and enter the market prior to the expiration of the 989
Patent in 2026 and/or the 459 Patent and the 460 Patent in 2028.
Hormonal Contraceptive Patent and Other Litigation Matters
LOESTRIN 24 FE Patent Litigation
In April 2011, the Company received a Paragraph IV certification notice letter from Mylan, as U.S. agent for Famy Care Ltd. (Famy Care), indicating that Famy Care had submitted to the FDA an
ANDA seeking approval to manufacture and sell a generic version of the Companys oral contraceptive, LOESTRIN 24 FE. The notice letter contends that the Companys U.S. Patent No. 5,552,394 (the 394 Patent), which
covers LOESTRIN 24 FE and expires in 2014, is invalid, unenforceable or not infringed. In June 2011, the Company filed a lawsuit against Famy Care and Mylan in the U.S. District Court for the District of New Jersey charging each with infringement of
the 394 Patent. The lawsuit results in a stay of FDA approval of Famy Cares ANDA for 30 months from the date of the Companys receipt of the Famy Care notice
21
letter, subject to the prior resolution of the matter before the court. A trial has been scheduled to begin on August 12, 2013. In January 2009, the Company entered into a settlement and license
agreement with Actavis to resolve patent litigation related to the 394 Patent. Under the agreement, Actavis agreed, among other things, not to commence marketing its generic equivalent product until the earliest of (i) January 22,
2014, (ii) 180 days prior to a date on which the Company has granted rights to a third party to market a generic version of LOESTRIN 24 FE in the United States or (iii) the date on which a third party enters the market with a generic
version of LOESTRIN 24 FE in the United States without authorization from the Company. In addition, under current law, unless Actavis forfeits its first filer status, the FDA may not approve later-filed ANDAs until 180 days following the
date on which Actavis enters the market. However, the Company believes Actavis may have forfeited its first filer status as a result of its failure to obtain approval by the FDA of its ANDA within the requisite period. In October 2010,
the Company also entered into a settlement and license agreement with Lupin Ltd. and its U.S. subsidiary, Lupin Pharmaceuticals, Inc. (collectively with their affiliates, Lupin), to resolve patent litigation related to the 394
Patent. Under that agreement, Lupin and its affiliates agreed, among other things, not to market or sell a generic equivalent product until the earlier of July 22, 2014 (the date on which the 394 Patent expires) or the date of an
at-risk entry into the U.S. market by a third party generic version of LOESTRIN 24 FE. While the Company intends to vigorously defend the 394 Patent and pursue its legal rights, it can offer no assurance that a generic
equivalent of LOESTRIN 24 FE will not be approved and enter the market prior to the expiration of the 394 Patent in 2014.
Other
LOESTRIN 24 FE Litigation
Commencing in April 2013, multiple putative antitrust class actions were filed against the
Company, Actavis and Lupin in the U.S. District Court for the Eastern District of Pennsylvania, the U.S. District Court for the District of New Jersey and the U.S. District Court for the District of Rhode Island by purported direct and indirect
purchasers of the Companys LOESTRIN 24 FE product. The Company has filed a motion with the Joint Panel on Multidistrict Litigation to consolidate all of the actions in a single proceeding before a single court, which is pending.
The complaints allege that the plaintiffs paid higher prices for the Companys LOESTRIN 24 FE product as a result of the
Companys and Actaviss and/or Lupins alleged actions preventing or delaying generic competition in violation of U.S. federal antitrust laws and/or state laws. Plaintiffs seek, among other things, unspecified treble, multiple and/or
punitive damages, injunctive relief and attorneys fees.
The Company intends to vigorously defend itself in the
litigation. However, it is impossible to predict with certainty the outcome of any litigation, and the Company can offer no assurance as to the timing of any such litigation or whether the Company will be successful in any such defense. In addition,
repetitive class action complaints asserting similar claims and allegations are common in antitrust litigation, and the Company may be subject to additional complaints from plaintiffs of the same or other classes. If these claims are successful,
such claims could adversely affect the Company and could have a material adverse effect on the Companys business, financial condition, results of operation and cash flows. These proceedings are in the early stages of litigation, and an
estimate of the potential loss, or range of loss, if any, to the Company relating to these proceedings is not possible at this time.
LO
LOESTRIN FE
In July 2011 and April 2012, the Company received Paragraph IV certification notice letters from
Lupin and Actavis indicating that each had submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Companys oral contraceptive, LO LOESTRIN FE. The notice letters contend that the
394 Patent and the Companys U.S. Patent No. 7,704,984 (the 984 Patent), which cover LO LOESTRIN FE and expire in 2014 and 2029, respectively, are invalid and/or not infringed. The Company filed a lawsuit
against Lupin in September 2011 and against Actavis in May 2012 in the U.S. District Court for the District of New Jersey charging each with infringement of the 394 Patent and the 984 Patent. A joint trial has been scheduled to
begin on October 7, 2013. The Company has granted Lupin and Actavis covenants not to sue on the 394 Patent with regard to their ANDAs seeking approval for a generic version of LO LOESTRIN FE, and the court dismissed all claims concerning
the 394 Patent in the Lupin and the Actavis litigations in December 2012 and February 2013, respectively. The lawsuits result in a stay of FDA approval of each defendants ANDA for 30 months from the date of the Companys
receipt of such defendants notice letter, subject to the prior resolution of the matter before the court.
While the
Company intends to vigorously defend the 984 Patent and pursue its legal rights, it can offer no assurance as to when the lawsuits will be decided, whether such lawsuits will be successful or that a generic equivalent of LO LOESTRIN FE will
not be approved and enter the market prior to the expiration of the 984 Patent in 2029.
Dermatology Patent and Other Litigation
Matters
DORYX Patent Litigation
In March 2009, the Company and Mayne Pharma International Pty. Ltd. (Mayne) received Paragraph IV certification notice letters from Impax and Mylan indicating that each had submitted to
the FDA an ANDA seeking approval to manufacture and sell a generic version of DORYX 150. The notice letters contended that Maynes 161 Patent expiring in 2022 was not infringed. In March and May 2009, the Company and Mayne, which licenses
the 161 Patent to the Company, filed lawsuits against Impax and Mylan, respectively, in the
22
U.S. District Court for the District of New Jersey, charging each with infringement of the 161 Patent. The resulting 30-month stay of FDA approval of each of Mylans and Impaxs
ANDAs with respect to DORYX 150 expired in September 2011. In advance of that stays expiration, the Company and Mayne filed a motion in the District Court for a preliminary injunction (PI) to prevent an at-risk launch
by Mylan of its generic version of DORYX 150. On September 22, 2011, the District Court entered a PI against Mylan and, in connection therewith, required the Company and Mayne to post a bond in the amount of $36 million (the Bond)
in respect of damages, if any, that might result to Mylan should the PI later be determined to have been improvidently granted. The Company and Mayne posted the Bond and Mylan appealed the District Courts grant of the PI to the U.S. Court of
Appeals for the Federal Circuit. The Federal Circuit vacated the PI on December 12, 2011 due to the District Courts failure to hold an evidentiary hearing, and suggested that the District Court consolidate such an evidentiary hearing with
the trial and consider entry of a temporary restraining order (TRO) prohibiting Mylan from launching a generic version of DORYX 150 until the District Court rendered its decision on the merits.
In September 2011, the Company received FDA approval for a dual-scored DORYX 150 product, which today accounts for all but a de minimis
amount of the Companys DORYX net sales, and filed a citizen petition requesting that the FDA refrain from granting final approval to any DORYX 150 ANDA unless the ANDA filers product also adopts a dual-scored configuration and has the
same labeling as the Companys dual-scored DORYX 150 product. On February 8, 2012, the FDA denied the Companys citizen petition and granted final approval to Mylan for its generic version of DORYX 150. As of July 15, 2013, Impax has
not yet received final approval of its ANDA from the FDA with respect to DORYX 150 and has forfeited its first filer status.
The actions against Mylan and Impax were consolidated and a trial was held in early February 2012, during which Mylan agreed to the entry of the TRO. In entering the TRO, the District Court denied
Mylans request that the Company post another bond or the Bond amount be increased from $36 million. On April 30, 2012, the District Court issued its opinion upholding the validity of the 161 Patent, but determining that neither
Mylans nor Impaxs proposed generic version of DORYX 150 infringed the 161 Patent. The Company appealed the non-infringement determinations, and Impax and Mylan appealed the District Courts denial of their attorneys
fees. On September 7, 2012, the Federal Circuit affirmed the District Courts decision. The Company determined not to petition the panel for a rehearing and the Federal Circuits judgment issued on October 15, 2012.
As a consequence of the District Courts April 30th ruling, Mylan entered the market with its FDA approved generic equivalent
of DORYX 150 in early May 2012. Under settlement agreements previously entered into with Heritage Pharmaceuticals Inc. (Heritage) and Sandoz Inc. (Sandoz) in connection with their respective ANDA challenges, each of Heritage
and Sandoz can market and sell a generic equivalent of DORYX 150 upon receipt of final FDA approval for its generic product.
The loss of exclusivity for DORYX 150 resulted in a significant decline in the Companys DORYX 150 revenues in the year ended
December 31, 2012. In addition, the Company recorded an impairment charge of $101 million in the quarter ended June 30, 2012 related to its DORYX intangible asset. On November 9, 2012, Mylan made an application to the District Court
seeking to recover damages under the Bond, alleging it was damaged from the District Courts entry of injunctions prior to the District Courts decision on the merits. The Company recorded a charge in the year ended December 31, 2012
in accordance with ASC Topic 450 Contingencies in the amount of $6 million in connection with the Federal Circuits judgment and Mylans application for damages. This charge represents the Companys current estimate of the
aggregate amount that is probable to be paid in connection with Mylans damages claim.
Although the Company intends to
vigorously defend itself from Mylans damages claim, it is impossible to predict with certainty the outcome concerning Mylans application. The Company can offer no assurance that amounts actually paid will not be more than the amount
recorded by the Company, or that an unfavorable outcome will not have an adverse and material impact on the Companys results of operations and cash flows.
Other DORYX Litigation
In July 2012, Mylan filed a complaint
against the Company and Mayne in the U.S. District Court for the Eastern District of Pennsylvania alleging that the Company and Mayne prevented or delayed Mylans generic competition to the Companys DORYX products in violation of U.S.
federal antitrust laws and tortiously interfered with Mylans prospective economic relationships under Pennsylvania state law. In the complaint, Mylan seeks unspecified treble and punitive damages and attorneys fees.
Following the filing of Mylans complaint, three putative class actions were filed against the Company and Mayne by purported direct
purchasers, and one putative class action was filed against the Company and Mayne by purported indirect purchasers, each in the same court. In each case the plaintiffs allege that they paid higher prices for the Companys DORYX products as a
result of the Companys and Maynes alleged actions preventing or delaying generic competition in violation of U.S. federal antitrust laws and/or state laws. Plaintiffs seek unspecified injunctive relief, treble damages and/or
attorneys fees. The court consolidated the purported class actions and the action filed by Mylan and ordered that all the pending cases proceed on the same schedule.
On February 5, 2013, four retailers filed in the same court a civil antitrust complaint in their individual capacities against the Company and Mayne regarding DORYX. On March 28, 2013, another
retailer filed a similar complaint in the same court. Both retailer complaints recite similar facts and assert similar legal claims for relief to those asserted in the related cases described above. Both retailer complaints have been consolidated
with the cases described above.
23
The Company and Mayne moved to dismiss the claims of Mylan, the direct purchasers, the
indirect purchasers and the retailers. On November 21, 2012, the Federal Trade Commission filed with the court an amicus curiae brief supporting the plaintiffs theory of relief. On June 12, 2013, the court entered a denial, without
prejudice, of the Company and Maynes motions to dismiss. Discovery is ongoing in the consolidated cases. Plaintiffs motions for class certification remain pending before the court, with no class having yet been certified.
The Company intends to vigorously defend its rights in the litigations. However, it is impossible to predict with certainty the outcome
of any litigation, and the Company can offer no assurance as to when the lawsuits will be decided, whether the Company will be successful in its defense and whether any additional similar suits will be filed. If these claims are successful such
claims could adversely affect the Company and could have a material adverse effect on the Companys business, financial condition, results of operation and cash flows. These proceedings are in the early stages of litigation, and an estimate of
the potential loss, or range of loss, if any, to the Company relating to these proceedings is not possible at this time.
Bayer Patent
Litigation
In August 2012, Bayer Pharma AG (together with its affiliates, Bayer) filed a complaint
against the Company in the U.S. District Court for the District of Delaware alleging that the Companys manufacture, use, offer for sale, and/or sale of its LO LOESTRIN FE oral contraceptive product infringes Bayers U.S. Patent
No. 5,980,940. In the complaint, Bayer seeks injunctive relief and unspecified monetary damages for the alleged infringement. In December 2012, Bayer amended the complaint to add a patent interference claim seeking to invalidate the
Companys 984 Patent, which covers the LO LOESTRIN FE product.
On February 19, 2013, Bayer filed a complaint
against the Company in the U.S. District Court for the District of Nevada alleging that the Companys LOESTRIN 24 FE oral contraceptive product infringes Bayers U.S. Patent No. RE43,916. In the complaint, Bayer seeks unspecified monetary
damages for the alleged infringement.
Although it is impossible to predict with certainty the outcome of any litigation, the
Company believes that it has a number of strong defenses to the allegations in the complaints and intends to vigorously defend the litigations. These cases are in the early stages of litigation, and an estimate of the potential loss, or range of
loss, if any, to the Company relating to these proceedings is not possible at this time.
CMS False Claims Act Litigation
In December 2009, the Company was served with a civil complaint brought by an individual plaintiff in the U.S. District Court for the
District of Massachusetts, purportedly on behalf of the United States, alleging that the Company and over 20 other pharmaceutical manufacturers violated the False Claims Act (FCA), 31 U.S.C. § 3729(a)(1)(A), (B), by submitting
false records or statements to the federal government, thereby causing Medicaid to pay for unapproved or ineffective drugs. The plaintiffs original complaint was filed under seal in 2002, but was not served on the Company until 2009. The
complaint alleges that the Company submitted to the Centers for Medicare and Medicaid Services (CMS) false information regarding the safety and effectiveness of certain nitroglycerin transdermal products. The plaintiff alleges that CMS
included these products in its list of reimbursable prescription drugs and that, as a consequence, federal Medicaid allegedly reimbursed state Medicaid programs for a portion of the cost of such products. The plaintiff asserts that from 1996 until
2003 the federal Medicaid program paid approximately $10 million to reimburse the states for such nitroglycerin transdermal products. The complaint seeks, among other things, treble damages; a civil penalty of up to ten thousand dollars for each
alleged false claim; and costs, expenses and attorneys fees.
The Company intends to defend this action vigorously and
currently believes that the complaint lacks merit. The Company has a number of defenses to the allegations in the complaint and has, along with its co-defendants, filed a joint motion to dismiss the action, which was granted on procedural grounds on
February 25, 2013. Once the Court enters a separate and final judgment, the plaintiff will have 30 days to file a notice of appeal. In addition, the United States of America has declined to intervene in this action with respect to the Company.
Although it is impossible to predict with certainty the outcome of any litigation, an unfavorable outcome in these proceedings is not anticipated. An estimate of the potential loss, or range of loss, if any, to the Company relating to these
proceedings is not possible at this time.
Governmental Investigation and False Claims Act Litigation
Beginning in February 2012, the Company, along with several current and former non-executive employees in its sales organization and
certain third parties, received subpoenas from the United States Attorney for the District of Massachusetts. The subpoena received by the Company seeks information and documentation relating to a wide range of matters, including sales and marketing
activities, payments to people who are in a position to recommend drugs, medical education, consultancies, prior authorization processes, clinical trials, off-label use and employee training (including with respect to laws and regulations concerning
off-label information and physician remuneration), in each case relating to all of the Companys current key products. The Company is cooperating in responding to the subpoena but cannot predict or determine the impact of this inquiry on its
future financial condition or results of operations.
24
The Company has become aware of two
qui tam
complaints filed by former Company sales representatives
and unsealed in February and March 2013. The unsealed
qui tam
complaints allege that the Company violated Federal and state false claims acts through the promotion of all of the Companys current key products by, among other things,
making improper claims concerning the products, providing kickbacks to physicians and engaging in improper conduct concerning prior authorizations. The complaints seek, among other things, treble damages, civil penalties of up to eleven thousand
dollars for each alleged false claim and attorneys fees and costs. Other similar complaints may exist under seal. The United States of America has elected not to intervene at this time in each of the unsealed
qui tam
actions, stating at
the times of the relevant seal expirations that its investigation of the allegations raised in the relevant complaint was continuing and, as such, it was not able to decide at such time whether to intervene in the action. The United States of
America may later seek to intervene, and its election does not prevent the plaintiffs/relators from litigating the actions. The Company intends to vigorously defend itself in the litigations. However, these cases are in the early stages of
litigation, it is impossible to predict with certainty the outcome of any litigation, and the Company can offer no assurance as to when the lawsuits will be decided, whether the Company will be successful in its defense and whether any additional
similar suits will be filed. If these claims are successful such claims could adversely affect the Company and could have a material adverse effect on the Companys business, financial condition, results of operation and cash flows. An estimate
of the potential loss, or range of loss, if any, to the Company relating to these proceedings is not possible at this time.
16. Income Taxes
The Company operates in many tax jurisdictions, including: Ireland, the United States, the United Kingdom, Puerto Rico,
Germany, Switzerland, Canada and other Western European countries. The Companys effective tax rate for the quarter and six months ended June 30, 2013 was 16% and 19%, respectively. The Companys effective tax rate for the quarter and six
months ended June 30, 2012 was 41% and 30%, respectively. The effective income tax rate for interim reporting periods reflects the changes in income mix among the various tax jurisdictions in which the Company operates, the impact of discrete items,
as well as the overall level of consolidated income before income taxes. The Companys effective tax rate is impacted by a significant portion of the Companys pretax income being generated in Puerto Rico, which is taxed at 2%. As a
result, the estimated annual effective tax rates applied to income before discrete items for the periods are significantly below 35%. For the six months ended June 30, 2013, the discrete items did not have a significant impact on the effective tax
rate. For the six months ended June 30, 2012, the discrete items, all of which negatively impacted the Companys effective tax rate, included reserves related to the restructuring of certain of the Companys Western European operations as
well as the impairment charge relating to the DORYX intangible asset. The Companys estimated annual effective tax rate for all periods includes the impact of changes in income tax liabilities related to reserves recorded under ASC Topic 740
Accounting for Income Taxes.
17. Segment Information
Effective October 1, 2012, the Company considers its business to be a single segment entity constituting the
development, manufacture and sale on a global basis of pharmaceutical products. The Companys chief operating decision maker (the CEO) evaluates the various global products on a net sales basis. Executives reporting to the CEO
include those responsible for operations and supply chain management, R&D, sales and certain corporate functions. The CEO evaluates profitability, investment and cash flow metrics on a consolidated worldwide basis due to shared infrastructure
and resources. In addition, the CEO reviews U.S. revenue specifically as it constitutes the substantial majority of the Companys overall revenue. Prior to October 1, 2012, the Companys business was organized as two segments: North
America and the Rest of World, consistent with how the Companys business was run at that time.
25
The following table presents total revenues by product for the quarters and six months ended
June 30, 2013 and 2012:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
Six Months Ended
|
|
|
Six Months Ended
|
|
(dollars in millions)
|
|
June 30, 2013
|
|
|
June 30, 2012
|
|
|
June 30, 2013
|
|
|
June 30, 2012
|
|
Revenue breakdown by product:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASACOL
|
|
$
|
140
|
|
|
$
|
187
|
|
|
$
|
293
|
|
|
$
|
398
|
|
ACTONEL(1)
|
|
|
96
|
|
|
|
150
|
|
|
|
207
|
|
|
|
296
|
|
LOESTRIN 24 FE
|
|
|
91
|
|
|
|
97
|
|
|
|
184
|
|
|
|
205
|
|
DELZICOL
|
|
|
67
|
|
|
|
|
|
|
|
72
|
|
|
|
|
|
LO LOESTRIN FE
|
|
|
59
|
|
|
|
34
|
|
|
|
111
|
|
|
|
62
|
|
ESTRACE Cream
|
|
|
53
|
|
|
|
46
|
|
|
|
106
|
|
|
|
98
|
|
ENABLEX
|
|
|
30
|
|
|
|
41
|
|
|
|
72
|
|
|
|
85
|
|
DORYX
|
|
|
22
|
|
|
|
23
|
|
|
|
41
|
|
|
|
53
|
|
ATELVIA
|
|
|
18
|
|
|
|
16
|
|
|
|
37
|
|
|
|
32
|
|
Other Womens Healthcare
|
|
|
12
|
|
|
|
14
|
|
|
|
24
|
|
|
|
29
|
|
Other Hormone Therapy
|
|
|
11
|
|
|
|
7
|
|
|
|
23
|
|
|
|
21
|
|
Other Oral Contraceptives
|
|
|
6
|
|
|
|
4
|
|
|
|
12
|
|
|
|
10
|
|
Other products
|
|
|
4
|
|
|
|
12
|
|
|
|
11
|
|
|
|
24
|
|
Contract manufacturing product sales
|
|
|
2
|
|
|
|
4
|
|
|
|
8
|
|
|
|
6
|
|
Other revenue
|
|
|
2
|
|
|
|
3
|
|
|
|
5
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
613
|
|
|
$
|
638
|
|
|
$
|
1,206
|
|
|
$
|
1,323
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Other revenue related to ACTONEL is combined with product net sales for purposes of presenting revenue by product.
|
The following table presents total revenue by significant country of domicile for the quarters and six months ended June 30, 2013
and 2012:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
Six Months Ended
|
|
|
Six Months Ended
|
|
(dollars in millions)
|
|
June 30, 2013
|
|
|
June 30, 2012
|
|
|
June 30, 2013
|
|
|
June 30, 2012
|
|
United States
|
|
$
|
536
|
|
|
$
|
525
|
|
|
$
|
1,049
|
|
|
$
|
1,092
|
|
Canada
|
|
|
18
|
|
|
|
24
|
|
|
|
32
|
|
|
|
47
|
|
United Kingdom / Republic of Ireland
|
|
|
13
|
|
|
|
13
|
|
|
|
26
|
|
|
|
26
|
|
France
|
|
|
11
|
|
|
|
27
|
|
|
|
22
|
|
|
|
57
|
|
Spain
|
|
|
6
|
|
|
|
9
|
|
|
|
12
|
|
|
|
18
|
|
Puerto Rico
|
|
|
3
|
|
|
|
7
|
|
|
|
12
|
|
|
|
12
|
|
Other
|
|
|
12
|
|
|
|
14
|
|
|
|
24
|
|
|
|
36
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales
|
|
|
599
|
|
|
|
619
|
|
|
|
1,177
|
|
|
|
1,288
|
|
Other revenue(1)
|
|
|
14
|
|
|
|
19
|
|
|
|
29
|
|
|
|
35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
613
|
|
|
$
|
638
|
|
|
$
|
1,206
|
|
|
$
|
1,323
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Includes royalty revenue and contractual payments from the Companys co-promotion partners.
|
18. Reliance on Significant Suppliers
In the event that a significant supplier (including a third-party manufacturer, packager or supplier of certain active
pharmaceutical ingredients, or API) suffers an event that causes it to be unable to manufacture or package the Companys product or meet the Companys API requirements for a sustained period and the Company is unable to obtain
the product or API from an alternative supplier, the resulting shortages of inventory could have a material adverse effect on the Companys business. The following table presents, by category of supplier, the percentage of the Companys
total revenues generated from products provided by each individual third-party supplier accounting for 10% or more of the Companys total revenues.
26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
API Supply:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cambrex Corporation
|
|
|
31
|
%
|
|
|
26
|
%
|
|
|
25
|
%
|
|
|
26
|
%
|
Lonza Inc.
|
|
|
19
|
%
|
|
|
26
|
%
|
|
|
20
|
%
|
|
|
25
|
%
|
Bayer
|
|
|
18
|
%
|
|
|
17
|
%
|
|
|
18
|
%
|
|
|
18
|
%
|
Merck & Co., Inc.
|
|
|
10
|
%
|
|
|
5
|
%
|
|
|
9
|
%
|
|
|
5
|
%
|
|
|
|
|
|
Manufacturing:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Norwich Pharmaceuticals Inc. (NPI)
|
|
|
19
|
%
|
|
|
26
|
%
|
|
|
20
|
%
|
|
|
25
|
%
|
|
|
|
|
|
Packaging:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NPI
|
|
|
32
|
%
|
|
|
27
|
%
|
|
|
28
|
%
|
|
|
28
|
%
|
Packaging Coordinators, Inc. (formerly AndersonBrecon)
|
|
|
13
|
%
|
|
|
15
|
%
|
|
|
14
|
%
|
|
|
15
|
%
|
19. Retirement Plans
The Company has defined benefit retirement pension plans covering certain employees in Western Europe. Retirement
benefits are generally based on an employees years of service and compensation. Funding requirements are determined on an individual country and plan basis and are subject to local country practices and market circumstances.
The net periodic benefit (income) of the Companys non-U.S. defined benefit plans amounted to $(1) million and $(7) million for the
quarters ended June 30, 2013 and 2012, respectively. Included in the net periodic benefit (income) for the quarters ended June 30, 2013 and 2012 are curtailment gains of $(1) million and $(7) million, respectively, in connection with the
Western European restructuring described in Note 4. The net periodic benefit (income) of the Companys non-U.S. defined benefit plans amounted to $0 and $(7) million for the six months ended June 30, 2013 and 2012,
respectively. Included in the net periodic benefit (income) for the six months ended June 30, 2013 and 2012 are curtailment gains of $(1) million and $(8) million, respectively, in connection with the Western European restructuring.
27