Warner Chilcott plc (Nasdaq:WCRX) today announced its results for
the quarter ended June 30, 2013.
Total revenue in the quarter ended June 30, 2013 was $613
million, a decrease of $25 million, or 4%, compared to the quarter
ended June 30, 2012. This decrease was driven primarily by a
decline in ACTONEL revenues of $54 million, due in large part to
overall declines in the U.S. oral bisphosphonate market and
continued declines in ACTONEL revenues in Western Europe and Canada
following the 2010 loss of exclusivity in both regions, offset, in
part, by combined net sales growth in our gastroenterology
franchise. Within our gastroenterology franchise, a decrease in
ASACOL net sales of $47 million in the quarter ended June 30, 2013
as compared to the prior year quarter, due primarily to our
transition from ASACOL 400 mg to DELZICOL, was more than offset by
DELZICOL net sales of $67 million in the quarter ended June 30,
2013. We also reported net sales growth in certain other promoted
products, primarily LO LOESTRIN FE, which saw an increase in net
sales of $25 million, or 74%, in the quarter ended June 30, 2013 as
compared to the prior year quarter.
We reported GAAP net income of $108 million, or $0.43 per
diluted share, in the quarter ended June 30, 2013, compared to
GAAP net income of $53 million, or $0.21 per diluted share, in the
quarter ended June 30, 2012. Cash net income (or CNI, as
defined below) for the quarter ended June 30, 2013 was $222
million, compared to $278 million in the prior year quarter.
Adjusted CNI was $232 million, or $0.92 per diluted share, in the
quarter ended June 30, 2013, compared to adjusted CNI of $258
million, or $1.03 per diluted share, in the prior year quarter. In
computing adjusted CNI for the quarter ended June 30, 2013, we
excluded restructuring income of $1 million, net of tax, related to
the restructuring of certain of our Western European operations and
$11 million, net of tax, of fees related to the Actavis Transaction
(defined below). In computing adjusted CNI for the quarter ended
June 30, 2012, we excluded a gain of $20 million, net of tax,
relating to the reversal of the liability for contingent milestone
payments to Novartis Pharmaceuticals Corporation ("Novartis") in
connection with our acquisition of the U.S. rights to ENABLEX in
October 2010 (the "ENABLEX Acquisition"), based on the
determination that it was no longer probable that we would be
required to make such payments.
References in this press release to "cash net income" or "CNI"
mean our GAAP net income adjusted for the after-tax effects of two
non-cash items: amortization (including impairments, if any) of
intangible assets and amortization (including write-offs, if any)
of deferred loan costs related to our debt. Adjusted CNI represents
CNI as further adjusted to exclude the impact, on an after-tax
basis, of the Western European restructuring, litigation-related
charges, Actavis Transaction fees and the gain relating to the
reversal of the liability for contingent milestone payments.
Reconciliations from our reported results in accordance with
Generally Accepted Accounting Principles in the United States
("GAAP") to CNI, adjusted CNI and adjusted earnings before
interest, taxes, depreciation and amortization ("Adjusted EBITDA")
for all periods presented are included in the tables at the end of
this press release.
Actavis Transaction
On May 19, 2013, we 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 us (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" or the "Actavis Transaction"). At
the effective time of the Scheme, each of our shareholders will be
entitled to receive 0.160 of a newly issued New Actavis ordinary
share in exchange for each ordinary share of ours 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 we and Actavis will become wholly owned
subsidiaries of New Actavis.
The Transaction Agreement provides that if the Transaction
Agreement is terminated (i) by us 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 us 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 us $160 million, subject to reduction in certain
circumstances. The Transaction Agreement also contains customary
representations, warranties and covenants by Actavis and us.
In addition, on May 19, 2013, we 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, we have
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 us to Actavis pursuant to the ERA is an amount equal to
one percent of the aggregate value of our issued share capital.
The proposed Transaction has been unanimously approved by our
board of directors and the board of directors of Actavis, and is
supported by the management teams of both companies. We currently
expect 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 we announced that we 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 we 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.
New Product Approvals
In May 2013, the U.S. Food and Drug Administration ("FDA")
approved a new oral contraceptive, norethindrone acetate and
ethinyl estradiol chewable tablets and ferrous fumarate tablets,
for the prevention of pregnancy. In July 2013, the FDA approved the
use of the MINASTRIN 24 FE trade name for this product, and we
anticipate that we will commercially launch this product, under the
MINASTRIN 24 FE trade name, in early August 2013. We expect that
MINASTRIN 24 FE will become a promotional priority for our women's
healthcare sales force upon launch.
In April 2013, the FDA approved a 200 mg strength of DORYX
(doxycycline hyclate) Delayed-Release Tablets, a tetracycline-class
oral antibiotic. We commercially launched DORYX Delayed-Release 200
mg Tablets in July 2013.
In February 2013, the FDA approved DELZICOL (mesalamine)
400 mg delayed-release capsules, our new 400 mg mesalamine product
indicated for the treatment of mildly to moderately active
ulcerative colitis and for the maintenance of remission of
ulcerative colitis. We commercially launched DELZICOL in March
2013, and it is currently a promotional focus of our
gastroenterology sales force efforts.
Semi-Annual Dividend
On June 14, 2013, we paid a semi-annual cash dividend under
our dividend policy (the "Dividend Policy") in the amount of $0.25
per share, or $63 million in the aggregate. Any declaration by our
Board of Directors to pay future cash dividends subsequent to the
June 2013 semi-annual dividend is subject to Actavis's consent
under the terms of the Transaction Agreement and would also depend
on our earnings and financial condition and other relevant factors
at such time.
Revenue
Total revenue in the quarter ended June 30, 2013 was $613
million, a decrease of $25 million, or 4%, compared to the quarter
ended June 30, 2012. This decrease was driven primarily by a
decline in ACTONEL revenues of $54 million, due in large part to
overall declines in the U.S. oral bisphosphonate market and
continued declines in ACTONEL revenues in Western Europe and Canada
following the 2010 loss of exclusivity in both regions, offset, in
part, by combined net sales growth in our gastroenterology
franchise. Within our gastroenterology franchise, a decrease in
ASACOL net sales of $47 million in the quarter ended June 30, 2013
as compared to the prior year quarter, due primarily to our
transition from ASACOL 400 mg to DELZICOL, was more than offset by
DELZICOL net sales of $67 million in the quarter ended June 30,
2013. We also reported net sales growth in certain other promoted
products, primarily LO LOESTRIN FE, which saw an increase in net
sales of $25 million, or 74%, in the quarter ended June 30, 2013 as
compared to the prior year quarter.
Net sales of our oral contraceptive products increased $21
million, or 16%, in the quarter ended June 30, 2013, as
compared to the prior year quarter. LOESTRIN 24 FE generated net
sales of $91 million in the quarter ended June 30, 2013, a
decrease of 6%, compared with $97 million in the prior year
quarter. LOESTRIN 24 FE filled prescriptions continue to be
negatively impacted by our shift in promotional focus to LO
LOESTRIN FE beginning in early 2011. More specifically, the
decrease in LOESTRIN 24 FE net sales in the quarter ended
June 30, 2013 as compared to the prior year quarter was
primarily due to a decrease in filled prescriptions of 27%, offset,
in part, by higher average selling prices and a decrease in
sales-related deductions relative to the prior year quarter. LO
LOESTRIN FE, which is currently the primary promotional focus of
our women's healthcare sales force efforts, generated net sales of
$59 million and $34 million in the quarters ended June 30,
2013 and 2012, respectively, an increase of 74%. The increase in LO
LOESTRIN FE net sales in the quarter ended June 30, 2013
compared to the prior year quarter primarily relates to an increase
in filled prescriptions of 61%, a decrease in sales-related
deductions and higher average selling prices. In May 2013, the FDA
approved a new oral contraceptive, norethindrone acetate and
ethinyl estradiol chewable tablets and ferrous fumarate tablets,
for the prevention of pregnancy. In July 2013, the FDA approved the
use of the MINASTRIN 24 FE trade name for this product, and we
anticipate that we will commercially launch this product, under the
MINASTRIN 24 FE trade name, in early August 2013. We expect that
MINASTRIN 24 FE will become a promotional priority for our women's
healthcare sales force upon launch.
Total ACTONEL revenues were $96 million in the quarter ended
June 30, 2013, a decrease of $54 million, or 36%, compared to
the prior year quarter. Total ACTONEL revenues were comprised of
the following components:
|
Quarter
Ended |
|
|
|
June 30, |
Increase
(decrease) |
(dollars in millions) |
2013 |
2012 |
Dollars |
Percent |
United States |
$ 61 |
$ 90 |
$ (29) |
(32)% |
Non - U.S. |
23 |
44 |
(21) |
(48)% |
Total net
sales |
84 |
134 |
(50) |
(37)% |
|
|
|
|
|
Other revenue |
12 |
16 |
(4) |
(25)% |
Total ACTONEL
revenues |
$ 96 |
$ 150 |
$ (54) |
(36)% |
In the United States, ACTONEL net sales decreased $29 million,
or 32%, in the quarter ended June 30, 2013, as compared to the
prior year quarter, primarily due to a decrease in filled
prescriptions of 34% and an increase in sales-related deductions,
offset, in part, by higher average selling prices and an expansion
of pipeline inventories as compared to the prior year quarter. In
the United States, ACTONEL filled prescriptions continue to decline
due in part to declines in filled prescriptions within the overall
U.S. oral bisphosphonate market. The decline in ACTONEL net sales
outside of the United States in the quarter ended June 30,
2013 was due to the continued declines in ACTONEL revenues in
Western Europe and Canada following the 2010 loss of exclusivity in
both regions. We expect to continue to experience significant
declines in total ACTONEL revenues in future periods. ATELVIA,
which we began to promote in the United States in early 2011 and in
Canada in early 2012, generated net sales of $18 million and $16
million in the quarters ended June 30, 2013 and 2012,
respectively. In the United States, ATELVIA net sales in the
quarters ended June 30, 2013 and 2012 were $16 million and $14
million, respectively, an increase of 14%. The increase in ATELVIA
net sales in the United States in the quarter ended June 30,
2013 compared to the prior year quarter was due to higher average
selling prices and a decrease in sales-related deductions, offset,
in part, by a decrease in filled prescriptions of 13%.
Net sales of ESTRACE Cream increased $7 million, or 15%, in the
quarter ended June 30, 2013, as compared to the prior year
quarter. The increase in ESTRACE Cream net sales in the quarter
ended June 30, 2013 compared to the prior year quarter was
primarily due to higher average selling prices, an increase in
filled prescriptions of 8% and a decrease in sales-related
deductions relative to the prior year quarter.
Net sales of our gastroenterology products increased $20
million, or 11%, in the quarter ended June 30, 2013, compared
to the prior year quarter. Net sales of ASACOL were $140 million in
the quarter ended June 30, 2013, a decrease of $47 million, or
25%, compared to the prior year quarter. ASACOL net sales in North
America totaled $128 million and $175 million in the quarters ended
June 30, 2013 and 2012, respectively, including net sales in
the United States of $122 million and $169 million in the quarters
ended June 30, 2013 and 2012, respectively. The decrease in
ASACOL net sales in the United States in the quarter ended
June 30, 2013 as compared to the prior year quarter was due
primarily to our decision to cease trade shipments of ASACOL 400 mg
in the United States as we transitioned from ASACOL 400 mg to
DELZICOL in March 2013, offset, in part, by an increase in net
sales of ASACOL HD (800 mg). In February 2013, the FDA approved
DELZICOL, which we commercially launched in March 2013 and is
currently a promotional focus of our gastroenterology sales force
efforts. Net sales of DELZICOL for the quarter ended June 30,
2013 were $67 million. As a result of the terms pursuant to which
we shipped the initial trade units of DELZICOL in the quarter ended
March 31, 2013, we deferred $44 million of the gross revenues
(which do not account for applicable sales-related deductions)
generated thereby since the criteria to record such revenues were
not met as of March 31, 2013. We recognized all of such
deferred gross revenues (as reduced to account for applicable
sales-related deductions) in our condensed consolidated statement
of operations for the quarter ended June 30, 2013 as the
criteria to record such revenues were achieved. We expect that the
loss of ASACOL 400 mg net sales in the United States will be
offset, in part, by net sales of DELZICOL and increased net sales
of ASACOL HD (800 mg).
Net sales of ENABLEX decreased $11 million, or 27%, in the
quarter ended June 30, 2013, compared to the prior year
quarter. ENABLEX net sales in the quarter ended June 30, 2013
were impacted by a decrease in filled prescriptions of 45% and a
contraction of pipeline inventories, offset, in part, by a decrease
in sales-related deductions and higher selling prices relative to
the prior year quarter. We expect a continued decline in ENABLEX
net sales in 2013 due in part to the promotional priorities of our
urology sales force.
Net sales of DORYX decreased $1 million, or 4%, in the quarter
ended June 30, 2013, compared to the prior year quarter. The
decrease in DORYX net sales in the quarter ended June 30, 2013
relative to the prior year quarter was due primarily to the
introduction of generic competition for our DORYX 150 mg product in
early May 2012. In April 2013, the FDA approved a 200 mg strength
of DORYX (doxycycline hyclate) Delayed-Release Tablets, which we
commercially launched in July 2013.
Cost of Sales (Excluding Amortization and Impairment of
Intangible Assets)
Cost of sales (excluding amortization and impairment) increased
$11 million, or 16%, in the quarter ended June 30, 2013 as
compared to the prior year quarter, due primarily to costs incurred
in the current year period in relation to pre-launch preparation
for products approved during the first half of 2013, as well as
changes in the mix and volume of products sold.
Selling, General and Administrative ("SG&A")
Expenses
SG&A expenses for the quarter ended June 30, 2013 were
$202 million, an increase of $29 million, or 17%, from $173 million
in the prior year quarter. Advertising and promotion ("A&P")
expenses decreased $10 million, or 40%, in the quarter ended
June 30, 2013, as compared to the prior year quarter,
primarily due to a decrease in promotional expenses relative to the
prior year quarter. Selling and distribution expenses decreased $9
million, or 9%, in the quarter ended June 30, 2013, as
compared to the prior year quarter, primarily due to a $10 million
reduction in co-promote expenses as a result of the continued
declines in ACTONEL net sales in Western Europe and Canada
following the 2010 loss of exclusivity in both regions.
Specifically, included in selling and distribution expenses were
co-promote expenses of $50 million and $60 million in the quarters
ended June 30, 2013 and 2012, respectively (of which, $44
million related to the United States and Puerto Rico in each
quarter).
General, administrative and other ("G&A") expenses increased
$48 million, or 112%, in the quarter ended June 30, 2013 as
compared to the prior year quarter. Included in G&A expenses in
the quarter ended June 30, 2013 were $11 million of fees
related to the Transaction. Included in G&A expenses in the
quarter ended June 30, 2012 was a $20 million gain relating to
the reversal of the liability for contingent milestone payments to
Novartis in connection with the ENABLEX Acquisition, as such
payments have been deemed no longer probable of being paid in
accordance with ASC Topic 450 "Contingencies". Excluding the impact
of the $11 million of Transaction fees and the $20 million
contingent gain, G&A expenses increased $17 million, or 27%, in
the quarter ended June 30, 2013 relative to the prior year quarter,
primarily due to an increase in legal and professional fees.
Restructuring (Income) / Costs
In April 2011, we announced a plan to restructure our operations
in Belgium, the Netherlands, France, Germany, Italy, Spain,
Switzerland and the United Kingdom. The restructuring did not
impact our operations at our headquarters in Dublin, Ireland, our
facilities in Dundalk, Ireland, Larne, Northern Ireland or
Weiterstadt, Germany or our commercial operations in the United
Kingdom. We determined to proceed with the restructuring following
the completion of a strategic review of our operations in our
Western European markets where our product ACTONEL lost exclusivity
in late 2010.
In the quarter ended June 30, 2013, we recorded
restructuring income of $2 million ($1 million, net of tax), 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
curtailment gains of $1 million. In the quarter ended June 30,
2012, we incurred pretax severance costs of $7 million, which were
offset, in full, by pension-related curtailment gains of $7
million. In computing adjusted CNI, we add back to CNI the
after-tax impact of these restructuring (income) / costs. We do not
expect to record any material expenses relating to the Western
European restructuring in future periods.
Research and Development ("R&D")
Our investment in R&D for the quarter ended June 30,
2013 was $33 million, an increase of $10 million, or 43%, as
compared to the prior year quarter. Our R&D expenses consist of
our internal development costs, fees paid to contract development
groups, regulatory fees and license fees paid to third parties.
R&D expenditures are subject to fluctuation due to the timing
and stages of development of our various R&D projects.
Amortization and Impairment of Intangible
Assets
Amortization of intangible assets in the quarters ended
June 30, 2013 and 2012 was $110 million and $124 million,
respectively. Our amortization methodology is calculated on either
an economic benefit model or on a straight-line basis to match the
expected useful life of the asset, with identifiable assets
assessed individually or by product family. The economic benefit
model is based on expected future cash flows and typically results
in accelerated amortization for most of our products. We
continuously review the remaining useful lives of our identified
intangible assets based on each product or product family's
estimated future cash flows. In the event that we do not achieve
the expected cash flows from any of our products or lose market
exclusivity for any of our products as a result of the expiration
of a patent, the expiration of FDA exclusivity or an at-risk launch
of a competing generic product, we may accelerate amortization or
record an impairment charge in respect of the related intangible
asset, which may be material. Based on our review of future cash
flows, we recorded an impairment charge in the quarter ended
June 30, 2012 of $106 million, $101 million of which was
attributable to the impairment of our DORYX intangible asset
following Mylan Pharmaceuticals Inc.'s introduction of a generic
product in early May 2012. We expect our 2013 amortization expense
to decline compared to 2012 as most of our intangible assets are
amortized on an accelerated basis.
Net Interest Expense
Net interest expense for the quarter ended June 30, 2013
was $60 million, an increase of $8 million, or 15%, compared to $52
million in the prior year quarter. Included in net interest expense
in the quarter ended June 30, 2013 was $8 million relating to
the write-off of deferred loan costs associated with a $150 million
optional prepayment of term loan indebtedness made during the
quarter ended June 30, 2013 under our senior secured credit
facilities. Excluding this write-off of deferred loan costs, net
interest expense for the quarter ended June 30, 2013 was flat
as compared to the prior year quarter as higher interest expense on
outstanding indebtedness resulting from an increase in the weighted
average amount of indebtedness outstanding, was offset, in full, by
a reduction in the amortization of deferred loan costs.
Net Income, Cash Net Income and Adjusted Cash Net
Income
For the quarter ended June 30, 2013, we reported GAAP net
income of $108 million, or $0.43 per diluted share, CNI of $222
million, and adjusted CNI of $232 million, or $0.92 per diluted
share. Our earnings and adjusted CNI per share calculations for the
quarter are based on 252.8 million diluted ordinary shares
outstanding. In calculating CNI, we add back the after-tax impact
of the amortization (including impairments, if any) of intangible
assets and the amortization (including write-offs, if any) of
deferred loan costs related to our debt. These items are
tax-effected at the estimated marginal rates attributable to them.
In the quarter ended June 30, 2013, the marginal tax rate
associated with the amortization of intangible assets was 5% and
the marginal tax rate for the amortization (including write-offs)
of deferred loan costs was 6%. In calculating adjusted CNI in the
quarter ended June 30, 2013, we excluded the $1 million
after-tax impact of restructuring income relating to the Western
European restructuring and the $11 million after-tax impact of fees
related to the Actavis Transaction.
Liquidity, Balance Sheet and Cash Flows
As of June 30, 2013, our cash on hand was $224 million and
our total outstanding debt was $3,490 million, which consisted of
$2,233 million of term loan borrowings under our senior secured
credit facilities, $1,250 million aggregate principal amount of
7.75% senior notes due 2018 (the "7.75% Notes"), and $7 million of
unamortized premium related to the 7.75% Notes. We generated $175
million of cash from operating activities in the quarter ended
June 30, 2013, compared with $156 million of cash from
operating activities in the prior year quarter, an increase of $19
million, due primarily to the timing of movements in working
capital.
Additional Information Related to Net Sales
Period-over-period changes in the net sales of our products are
a function of a number of factors, including changes in market
demand, gross selling prices, sales-related deductions from gross
sales to arrive at net sales and the levels of pipeline inventories
of our products held by our direct and indirect customers. In
addition, the launch of new products, the loss of exclusivity for
our products and transactions such as product acquisitions and
dispositions may also, from time to time, impact our period over
period net sales. We use IMS Health, Inc. ("IMS") estimates of
filled prescriptions for our products as a proxy for market demand
in the United States. Although these estimates provide a broad
indication of market trends for our products in the United States,
the relationship between IMS estimates of filled prescriptions and
actual unit sales can vary, and as a result, such estimates may not
always be an accurate predictor of our unit sales. When our unit
sales to our direct customers in any period exceed market demand
for our products by end-users (as measured by estimates of filled
prescriptions or its equivalent in units), our sales in excess of
demand must be absorbed before our direct customers begin to order
again, thus potentially reducing our expected future unit sales.
Conversely, when market demand by end-users of our products exceeds
unit sales to our direct customers in any period, our expected
future unit sales to our direct customers may increase. We refer to
the estimated amount of inventory held by our direct customers and
pharmacies and other organizations that purchase our product from
our direct customers, which is generally measured by the estimated
number of days of end-user demand on hand, as "pipeline inventory."
Pipeline inventories expand and contract in the normal course of
business. As a result, our unit sales to our direct customers in
any period may exceed or be less than actual market demand for our
products by end-users (as measured by estimates of filled
prescriptions). When comparing reported product sales between
periods, it is important to not only consider market demand by
end-users, but also to consider whether estimated pipeline
inventories increased or decreased during each period.
2013 Financial Guidance Update
Based on our second quarter results and current outlook for the
remainder of 2013, we are updating our guidance ranges for adjusted
SG&A expenses and GAAP net income, as well as adjusted CNI and
adjusted CNI per share. The update is due primarily to lower than
expected A&P expenses, as well as the incurrence of fees
related to the Actavis Transaction. Adjusted CNI per share adds
back the after-tax impact of (i) restructuring income relating
to the Western European restructuring, (ii) litigation-related
charges and (iii) fees related to the Actavis Transaction. For
a complete overview of our updated full year 2013 guidance,
including material assumptions, please refer to the table at the
last page of this press release.
The Company
Warner Chilcott is a leading specialty pharmaceutical company
currently focused on the women's healthcare, gastroenterology,
urology and dermatology segments of the branded pharmaceuticals
market, primarily in North America. We are a fully integrated
company with internal resources dedicated to the development,
manufacture and promotion of our products. WCRX-F
Forward Looking Statements
This press release contains forward-looking statements,
including statements concerning the proposed transaction with
Actavis, our industry, our operations, our anticipated financial
performance and financial condition and our business plans, growth
strategy and product development efforts. These statements
constitute forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934. The words "may," "might,"
"will," "should," "estimate," "project," "plan," "anticipate,"
"expect," "intend," "outlook," "believe" and other similar
expressions are intended to identify forward-looking statements.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of their dates.
These forward-looking statements are based on estimates and
assumptions by our management that, although we believe to be
reasonable, are inherently uncertain and subject to a number of
risks and uncertainties. The following represent some, but not
necessarily all, of the factors that could cause actual results to
differ from historical results or those anticipated or predicted by
our forward-looking statements: the timing to consummate the
proposed transaction with Actavis; the risk that a condition to
closing of the proposed transaction with Actavis may not be
satisfied; the risk that a regulatory approval that may be required
for the proposed transaction with Actavis is delayed, is not
obtained or is obtained subject to conditions that are not
anticipated; New Actavis' ability to achieve the synergies and
value creation contemplated by the proposed acquisition; New
Actavis' ability to promptly and effectively integrate Actavis' and
our businesses; the diversion of management time on
transaction-related issues; our substantial indebtedness, including
increases in the LIBOR rates on our variable-rate indebtedness
above the applicable floor amounts; competitive factors and market
conditions in the industry in which we operate, including the
approval and introduction of generic or branded products that
compete with our products; our ability to protect our intellectual
property; a delay in qualifying any of our manufacturing facilities
that produce our products, production or regulatory problems with
either our own manufacturing facilities or those of third party
manufacturers, packagers or API suppliers upon whom we may rely for
some of our products or other disruptions within our supply chain;
pricing pressures from reimbursement policies of private managed
care organizations and other third party payors, government
sponsored health systems and regulatory reforms, and the continued
consolidation of the distribution network through which we sell our
products; changes in tax laws or interpretations that could
increase our consolidated tax liabilities; government regulation,
including U.S. and foreign health care reform, affecting the
development, manufacture, marketing and sale of pharmaceutical
products, including our ability and the ability of companies with
whom we do business to obtain necessary regulatory approvals;
adverse outcomes in our outstanding litigation, regulatory
investigations or arbitration matters or an increase in the number
of such matters to which we are subject; the loss of key senior
management or scientific staff; our ability to manage the growth of
our business by successfully identifying, developing, acquiring or
licensing new products at favorable prices and marketing such new
products; our ability to obtain regulatory approval and customer
acceptance of new products, and continued customer acceptance of
our existing products; and the other risks identified in our
periodic filings including our Annual Report on Form 10-K for the
year ended December 31, 2012, and from time-to-time in our
other investor communications.
We caution you that the foregoing list of important factors is
not exclusive. In addition, in light of these risks and
uncertainties, the matters referred to in our forward-looking
statements may not occur. We undertake no obligation to publicly
update or revise any forward-looking statement as a result of new
information, future events or otherwise, except as may be required
by law.
The guidance regarding GAAP net income, adjusted CNI and
adjusted CNI per share contained in this announcement constitutes a
profit forecast for the purposes of the Irish Takeover Rules. In
accordance with Rule 28.4 of the Irish Takeover Rules, this profit
forecast shall be repeated in the Registration Statement on Form
S-4 filed by New Actavis with the Securities and Exchange
Commission ("SEC") in connection with the Transaction Agreement and
the reports required by Rule 28.3 shall be mailed to Warner
Chilcott shareholders with the definitive proxy
statement/prospectus relating to the Transaction Agreement.
Statement Required by the Takeover Rules
The directors of Warner Chilcott accept responsibility for the
information contained in this announcement. To the best of the
knowledge and belief of the directors of Warner Chilcott (who have
taken all reasonable care to ensure such is the case), the
information contained in this announcement is in accordance with
the facts and does not omit anything likely to affect the import of
such information.
Deutsche Bank Securities Inc. is acting for Warner Chilcott as
financial advisor and is not acting as financial advisor to anyone
else in connection with the matters referred to in this
announcement and will not be responsible to anyone other than
Warner Chilcott in connection therewith for providing advice in
relation to the matters referred to in this announcement. Deutsche
Bank Securities Inc. has delegated certain of its financial
advisory functions and responsibilities to Deutsche Bank AG, acting
through its London branch. Deutsche Bank AG, acting through its
London branch is performing such delegated functions and
responsibilities exclusively for Warner Chilcott and is not acting
as a financial adviser for any other person in connection with the
matters referred to in this announcement and will not be
responsible to any such other person for providing advice in
relation to the matters referred to in this announcement. Deutsche
Bank AG is authorised under German Banking Law (competent
authority: BaFin – Federal Financial Supervisory Authority) and
authorised and subject to limited regulation by the Financial
Conduct Authority. Details about the extent of Deutsche Bank AG's
authorization and regulation by the Financial Conduct Authority are
available on request.
Important Information For Investors And
Shareholders
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval. New Actavis has filed with the SEC a
registration statement on Form S-4 containing a preliminary joint
proxy statement of Warner Chilcott and Actavis that also
constitutes a preliminary prospectus of New Actavis. The
registration statement has not been declared effective by the
SEC. After the registration statement has been declared
effective, each of Actavis and Warner Chilcott will mail to its
stockholders or shareholders a definitive proxy
statement/prospectus. In addition, each of New Actavis,
Actavis and Warner Chilcott will file with the SEC other documents
with respect to the proposed transaction. INVESTORS AND
SECURITY HOLDERS OF ACTAVIS AND WARNER CHILCOTT ARE URGED TO READ
THE DEFINITIVE PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS FILED
OR TO BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN
THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION. Investors and security holders may obtain free copies
of the registration statement and the proxy statement/prospectus
and other documents filed with the SEC by New Actavis, Actavis and
Warner Chilcott through the website maintained by the SEC at
http://www.sec.gov. Copies of the documents filed with the SEC by
New Actavis and Actavis may be obtained free of charge on Actavis's
internet website at www.actavis.com or by contacting Actavis's
Investor Relations Department at (862) 261-7488. Copies of the
documents filed with the SEC by Warner Chilcott may be obtained
free of charge on Warner Chilcott's internet website at
www.wcrx.com or by contacting Warner Chilcott's Investor Relations
Department at (973) 442-3200.
Actavis, Warner Chilcott, their respective directors and certain
of their executive officers may be considered participants in the
solicitation of proxies in connection with the proposed
transaction. Information about the directors and executive
officers of Warner Chilcott is set forth in its Annual Report on
Form 10-K for the year ended December 31, 2012, which was filed
with the SEC on February 22, 2013, its Quarterly Report on
Form 10-Q for the quarter ended March 31, 2013, which was filed
with the SEC on May 10, 2013, its proxy statement for its 2013
annual general meeting of shareholders, which was filed with the
SEC on April 5, 2013, and its Current Reports on Form 8-K that
were filed with the SEC on May 2, 2013 and May 8,
2013. Information about the directors and executive officers
of Actavis is set forth in its Annual Report on Form 10-K for the
year ended December 31, 2012, which was filed with the SEC on
February 28, 2013, its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2013, which was filed with the SEC on
May 7, 2013, its proxy statement for its 2013 annual meeting
of stockholders, which was filed with the SEC on March 29,
2013, and its Current Reports on Form 8-K that were filed with the
SEC on January 29, 2013 and May 13, 2013. Other
information regarding the participants in the proxy solicitations
and a description of their direct and indirect interests, by
security holdings or otherwise, are contained in the preliminary
proxy statement/prospectus filed with the SEC and will be contained
in the definitive proxy statement/prospectus and other relevant
materials to be filed with the SEC when they become available.
Reconciliations to GAAP Net Income
CNI and Adjusted CNI
To supplement our condensed consolidated financial statements
presented in accordance with GAAP, we provide a summary to show the
computation of CNI and adjusted CNI. CNI is defined as our GAAP net
income adjusted for the after-tax effects of two non-cash items:
amortization (including impairments, if any) of intangible assets
and amortization (including write-offs, if any) of deferred loan
costs related to our debt. Adjusted CNI represents CNI as further
adjusted to exclude the impact, on an after-tax basis, of the
Western European restructuring, litigation-related charges, Actavis
Transaction fees and the gain relating to the reversal of the
liability for contingent milestone payments. We believe that the
presentation of CNI and adjusted CNI provides useful information to
both management and investors concerning the approximate impact of
the above items. We also believe that considering the effect of
these items allows management and investors to better compare our
financial performance from period-to-period, and to better compare
our financial performance with that of our competitors. The
presentation of this additional information is not meant to be
considered in isolation of, or as a substitute for, results
prepared in accordance with GAAP.
Adjusted EBITDA
To supplement our condensed consolidated financial statements
presented in accordance with GAAP, we provide a summary to show the
computation of Adjusted EBITDA taking into account certain charges
that were taken during the quarters and six months ended
June 30, 2013 and 2012. The computation of Adjusted EBITDA is
based on the definition of Adjusted EBITDA contained in our senior
secured credit facilities.
Company Contacts: |
Rochelle Fuhrmann |
|
SVP, Finance |
|
973-442-3281 |
|
rfuhrmann@wcrx.com |
|
|
|
Kevin Crissey |
|
Director, Investor Relations |
|
973-907-7084 |
|
kevin.crissey@wcrx.com |
WARNER CHILCOTT PUBLIC
LIMITED COMPANY |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(In millions of U.S.
dollars, except per share amounts) |
(Unaudited) |
|
|
|
|
Quarter
Ended |
Six Months
Ended |
|
June 30, 2013 |
June 30, 2012 |
June 30, 2013 |
June 30, 2012 |
|
|
|
|
|
REVENUE |
|
|
|
|
Net sales |
$ 599 |
$ 619 |
$ 1,177 |
$ 1,288 |
Other revenue |
14 |
19 |
29 |
35 |
Total revenue |
613 |
638 |
1,206 |
1,323 |
COSTS, EXPENSES AND
OTHER |
|
|
|
|
Cost of sales (excludes
amortization and impairment of intangible assets) |
81 |
70 |
151 |
142 |
Selling, general and
administrative |
202 |
173 |
381 |
371 |
Restructuring (income) /
costs |
(2) |
— |
(3) |
50 |
Research and
development |
33 |
23 |
58 |
48 |
Amortization of intangible
assets |
110 |
124 |
220 |
254 |
Impairment of intangible
assets |
— |
106 |
— |
106 |
Interest expense,
net |
60 |
52 |
125 |
114 |
INCOME BEFORE TAXES |
129 |
90 |
274 |
238 |
Provision for income
taxes |
21 |
37 |
53 |
72 |
NET INCOME |
$ 108 |
$ 53 |
$ 221 |
$ 166 |
|
|
|
|
|
Earnings per share: |
|
|
|
|
Basic |
$ 0.43 |
$ 0.21 |
$ 0.89 |
$ 0.67 |
Diluted |
$ 0.43 |
$ 0.21 |
$ 0.88 |
$ 0.66 |
|
|
|
|
|
Dividends per share |
$ 0.25 |
$ — |
$ 0.25 |
$ — |
|
|
|
|
|
RECONCILIATIONS: |
|
|
|
|
GAAP Net income |
$ 108 |
$ 53 |
$ 221 |
$ 166 |
+ Amortization and impairment
of intangible assets, net of tax |
104 |
221 |
209 |
345 |
+ Amortization and write-offs
of deferred loan costs, net of tax |
10 |
4 |
23 |
16 |
CASH NET INCOME |
$ 222 |
$ 278 |
$ 453 |
$ 527 |
Non-recurring, one-time charges included
above: |
|
|
|
|
+ Western European
restructuring (income) / costs, net of tax |
(1) |
— |
(2) |
42 |
+ Litigation-related charges,
net of tax |
— |
— |
2 |
— |
+ Gain on reversal of the
liability for contingent milestone payments, net of tax |
— |
(20) |
— |
(20) |
+ Actavis Transaction fees, net
of tax |
11 |
— |
11 |
— |
ADJUSTED CASH NET
INCOME |
$ 232 |
$ 258 |
$ 464 |
$ 549 |
WARNER CHILCOTT PUBLIC
LIMITED COMPANY |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(In millions of U.S.
dollars) |
(Unaudited) |
|
|
|
|
As of |
As of |
|
June 30, 2013 |
December 31, 2012 |
ASSETS |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 224 |
$ 474 |
Accounts receivable,
net |
265 |
195 |
Inventories, net |
126 |
113 |
Prepaid expenses and other
current assets |
294 |
244 |
Total current assets |
909 |
1,026 |
|
|
|
Other assets: |
|
|
Property, plant and equipment,
net |
208 |
216 |
Intangible assets,
net |
1,597 |
1,817 |
Goodwill |
1,029 |
1,029 |
Other non-current
assets |
89 |
130 |
TOTAL ASSETS |
$ 3,832 |
$ 4,218 |
|
|
|
LIABILITIES |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 39 |
$ 29 |
Accrued expenses and other
current liabilities |
608 |
686 |
Current portion of long-term
debt |
190 |
179 |
Total current
liabilities |
837 |
894 |
|
|
|
Other liabilities: |
|
|
Long-term debt, excluding
current portion |
3,300 |
3,796 |
Other non-current
liabilities |
122 |
128 |
Total liabilities |
4,259 |
4,818 |
|
|
|
SHAREHOLDERS' (DEFICIT) |
(427) |
(600) |
TOTAL LIABILITIES AND SHAREHOLDERS'
(DEFICIT) |
$ 3,832 |
$ 4,218 |
WARNER CHILCOTT PUBLIC
LIMITED COMPANY |
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS |
(In millions of U.S.
dollars) |
(Unaudited) |
|
|
|
|
Quarter
Ended |
Six Months
Ended |
|
June 30, 2013 |
June 30, 2012 |
June 30, 2013 |
June 30, 2012 |
|
|
|
|
|
CASH FLOWS FROM OPERATING
ACTIVITIES |
|
|
|
|
Net income |
$ 108 |
$ 53 |
$ 221 |
$ 166 |
Adjustments to reconcile net income to net
cash provided by operating activities: |
|
|
|
|
Depreciation |
9 |
10 |
20 |
19 |
Amortization of intangible
assets |
110 |
124 |
220 |
254 |
Impairment of intangible
assets |
— |
106 |
— |
106 |
Non-cash gain relating to the
reversal of the liability for contingent milestone payments |
— |
(20) |
— |
(20) |
Amortization and write-off of
deferred loan costs |
11 |
5 |
25 |
17 |
Stock-based compensation
expense |
7 |
6 |
13 |
12 |
Changes in assets and liabilities: |
|
|
|
|
(Increase) in accounts
receivable, prepaid expenses and other current assets |
(61) |
(25) |
(101) |
(5) |
(Increase) in
inventories |
(9) |
(6) |
(14) |
(11) |
Increase / (decrease) in
accounts payable, accrued expenses and other current
liabilities |
47 |
(60) |
(69) |
(145) |
(Decrease) in income taxes and
other, net |
(47) |
(37) |
(26) |
(29) |
Net cash provided by operating
activities |
$ 175 |
$ 156 |
$ 289 |
$ 364 |
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES |
|
|
|
|
Proceeds from sale of assets |
15 |
— |
15 |
— |
Capital expenditures |
(5) |
(11) |
(12) |
(17) |
|
|
|
|
|
Net cash provided by / (used
in) investing activities |
$ 10 |
$ (11) |
$ 3 |
$ (17) |
|
|
|
|
|
CASH FLOWS FROM FINANCING
ACTIVITIES |
|
|
|
|
Term repayments under senior secured credit
facilities |
(192) |
(35) |
(484) |
(409) |
Cash dividends paid |
(59) |
— |
(59) |
— |
Redemption of ordinary shares |
— |
— |
— |
(32) |
Proceeds from the exercise of non-qualified
options to purchase ordinary shares |
2 |
2 |
3 |
8 |
Other |
(1) |
— |
— |
— |
|
|
|
|
|
Net cash (used in) financing
activities |
$ (250) |
$ (33) |
$ (540) |
$ (433) |
|
|
|
|
|
Effect of exchange rates on cash and cash
equivalents |
(1) |
(4) |
(2) |
— |
|
|
|
|
|
Net (decrease) / increase in cash and cash
equivalents |
(66) |
108 |
(250) |
(86) |
Cash and cash equivalents, beginning of
period |
290 |
422 |
474 |
616 |
Cash and cash equivalents, end of
period |
$ 224 |
$ 530 |
$ 224 |
$ 530 |
WARNER CHILCOTT PUBLIC
LIMITED COMPANY |
Reconciliation of Net
Income to Adjusted EBITDA |
(In millions of U.S.
dollars) |
(Unaudited) |
|
|
|
|
Quarter
Ended |
Six Months
Ended |
|
June 30, 2013 |
June 30, 2012 |
June 30, 2013 |
June 30, 2012 |
RECONCILIATION TO ADJUSTED
EBITDA: |
|
|
|
|
Net income - GAAP |
$ 108 |
$ 53 |
$ 221 |
$ 166 |
+ Interest expense, as
defined |
60 |
52 |
125 |
114 |
+ Provision for income
taxes |
21 |
37 |
53 |
72 |
+ Non-cash stock-based
compensation expense |
7 |
6 |
13 |
12 |
+ Depreciation |
9 |
10 |
20 |
19 |
+ Amortization of intangible
assets |
110 |
124 |
220 |
254 |
+ Impairment of intangible
assets |
— |
106 |
— |
106 |
+ R&D milestone
expense |
1 |
2 |
1 |
2 |
+ Non-cash gain relating to the
reversal of the liability for contingent milestone payments |
— |
(20) |
— |
(20) |
+ Restructuring (income) /
costs |
(2) |
— |
(3) |
50 |
+ Actavis Transaction
fees |
11 |
— |
11 |
— |
+ Other permitted
add-backs |
1 |
— |
5 |
— |
Adjusted EBITDA of WC plc, as
defined |
$ 326 |
$ 370 |
$ 666 |
$ 775 |
|
|
|
|
|
+ Expenses of WC plc and
other |
1 |
8 |
2 |
8 |
|
|
|
|
|
Adjusted EBITDA of Warner
Chilcott Holdings Company III, Limited, as defined |
$ 327 |
$ 378 |
$ 668 |
$ 783 |
|
Note: Warner Chilcott Holdings
Company III, Limited and certain of its subsidiaries are parties to
our senior secured credit facilities. Warner Chilcott plc is not a
party to this agreement. Certain expenses included in Warner
Chilcott plc's consolidated operating results are not deducted in
arriving at Adjusted EBITDA for Warner Chilcott Holdings Company
III, Limited and its subsidiaries. |
WARNER CHILCOTT PUBLIC
LIMITED COMPANY |
REVENUE BY
PRODUCT |
(In millions of U.S.
dollars) |
(Unaudited) |
|
|
|
|
Quarter
Ended |
Six Months
Ended |
|
June 30, 2013 |
June 30, 2012 |
June 30, 2013 |
June 30, 2012 |
Women's Healthcare: |
|
|
|
|
Oral Contraceptives |
|
|
|
|
LOESTRIN 24 FE |
$ 91 |
$ 97 |
$ 184 |
$ 205 |
LO LOESTRIN FE |
59 |
34 |
111 |
62 |
Other Oral
Contraceptives |
6 |
4 |
12 |
10 |
Total Oral Contraceptives |
156 |
135 |
307 |
277 |
|
|
|
|
|
Osteoporosis |
|
|
|
|
ACTONEL(1) |
96 |
150 |
207 |
296 |
ATELVIA |
18 |
16 |
37 |
32 |
Total Osteoporosis |
114 |
166 |
244 |
328 |
|
|
|
|
|
Hormone Therapy |
|
|
|
|
ESTRACE Cream |
53 |
46 |
106 |
98 |
Other Hormone
Therapy |
11 |
7 |
23 |
21 |
Total Hormone
Therapy |
64 |
53 |
129 |
119 |
|
|
|
|
|
Other women's healthcare
products |
12 |
14 |
24 |
29 |
Total Women's
Healthcare |
346 |
368 |
704 |
753 |
|
|
|
|
|
Gastroenterology: |
|
|
|
|
ASACOL |
140 |
187 |
293 |
398 |
DELZICOL |
67 |
— |
72 |
— |
Total
Gastroenterology |
207 |
187 |
365 |
398 |
|
|
|
|
|
Urology: |
|
|
|
|
ENABLEX |
30 |
41 |
72 |
85 |
|
|
|
|
|
Dermatology: |
|
|
|
|
DORYX |
22 |
23 |
41 |
53 |
|
|
|
|
|
Other: |
|
|
|
|
Other products net
sales |
4 |
12 |
11 |
24 |
Contract manufacturing product
sales |
2 |
4 |
8 |
6 |
Other revenue(2) |
2 |
3 |
5 |
4 |
Total Revenue |
$ 613 |
$ 638 |
$ 1,206 |
$ 1,323 |
|
|
|
|
|
(1) Includes "other
revenue" of $12 million and $16 million for the quarters ended
June 30, 2013 and 2012, respectively, and $24 million and $31
million for the six months ended June 30, 2013 and 2012,
respectively, as reported in our condensed consolidated statement
of operations, resulting from the collaboration agreement with
Sanofi-Aventis U.S. LLC. |
(2) Excludes "other revenue"
of $12 million and $16 million for the quarters ended June 30,
2013 and 2012, respectively, and $24 million and $31 million for
the six months ended June 30, 2013 and 2012, respectively,
reported in our condensed consolidated statement of operations,
resulting from the collaboration agreement with Sanofi-Aventis U.S.
LLC. |
WARNER CHILCOTT PUBLIC
LIMITED COMPANY |
SUMMARY OF SG&A
EXPENSE |
(In millions of U.S.
dollars) |
(Unaudited) |
|
|
|
|
Quarter Ended |
Quarter Ended |
|
June 30,
2013 |
June 30,
2012 |
A&P |
$ 15 |
$ 25 |
Selling and Distribution |
96 |
105 |
G&A |
91 |
43 |
|
|
|
Total
SG&A |
$ 202 |
$ 173 |
|
|
|
|
Six Months Ended |
Six Months Ended |
|
June 30, 2013 |
June 30, 2012 |
A&P |
$ 31 |
$ 49 |
Selling and Distribution |
191 |
214 |
G&A |
159 |
108 |
|
|
|
Total
SG&A |
$ 381 |
$ 371 |
WARNER CHILCOTT PUBLIC
LIMITED COMPANY |
2013 Full Year
Financial Guidance |
(In millions of U.S.
dollars, except per share and percentage information) |
|
|
|
|
Prior Guidance |
Current Guidance |
|
May 2013 |
July 2013 (1) |
|
|
|
Total Revenue |
$2,300 to 2,400 |
$2,300 to 2,400 |
Gross Margin as a % of Total
Revenue |
87% |
87% (2) |
Total SG&A Expense, as
Adjusted |
$ 750 to 800 |
$ 725 to 775 (3) |
Total R&D Expense |
$ 115 to 135 |
$ 115 to 135 |
Total Income Tax
Provision |
11%-12% of Adjusted EBTA |
11%-12% of Adjusted EBTA (4) |
GAAP Net Income |
$ 361 to 386 |
$ 366 to 391 |
Adjusted CNI |
$ 805 to 830 |
$ 834 to 859 (5) |
Adjusted CNI per share |
$ 3.20 to 3.30 |
$ 3.30 to
3.40 (5)(6) |
|
|
|
1 The 2013 guidance assumes
that no new or additional generic equivalents of the Company's
ASACOL 400 mg/DELZICOL, ESTRACE Cream, LOESTRIN 24 FE or DORYX
products will be approved and enter the U.S. market during
2013. In addition, the guidance does not: (i) assume the
launch of any new products not yet approved by the FDA,
(ii) account for the impact of any future acquisitions,
dispositions, partnerships or in-license transactions, any changes
to the Company's existing capital structure, business model,
partnerships or in-license transactions or any adverse outcome to
any litigation or government investigation or (iii) account for any
fees payable contingent upon consummation of the Actavis
Transaction. Any change in such assumptions could have a
negative impact on the Company's guidance. Also see "Forward
Looking Statements" above. |
2 Gross margin as a
percentage of total revenue excludes the amortization and
impairments of intangible assets. |
3 Total SG&A expense, as
adjusted, does not include (i) any amount that may be payable
in connection with the potential adjudication or settlement of the
Company's outstanding litigations and (ii) $11 million of fees
incurred through June 30, 2013 or $7 million of additional
non-contingent fees, in each case in connection with the Actavis
Transaction. |
4 The 2013 total income tax
provision is estimated as a percentage of earnings before taxes and
book amortization, adjusted to exclude the impact, as applicable,
of the items described in Footnote 5 below
(Adjusted EBTA). |
5 A reconciliation of 2013
expected GAAP net income to expected adjusted CNI adds back the
expected after tax impact of (i) the amortization and
impairment of intangibles ($417 million), (ii) the
amortization and write-off of deferred loan costs ($33 million),
(iii) fees incurred through June 30, 2013 ($11 million) and
additional non-contingent fees ($7 million), in each case in
connection with the Actavis Transaction, (iv) the Western
European restructuring income ($2 million) and
(v) litigation-related charges ($2 million). |
6 Expected adjusted CNI per
share is based on 252.6 million fully diluted ordinary shares.
The Company did not redeem any ordinary shares under its current
$250 million share redemption program in the six months ended
June 30, 2013, and the 2013 calculation of fully diluted
ordinary shares does not include the impact of any ordinary shares
that may be redeemed after June 30, 2013 pursuant to such
share redemption program or otherwise. |
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