For
the quarterly period ended March 31, 2009
|
Commission
File No. 1-11083
|
DELAWARE
|
04-2695240
|
(State
of Incorporation)
|
(I.R.S.
Employer Identification No.)
|
Large
accelerated filer x
|
Accelerated filer
o
|
Non-accelerated
filer o
|
Smaller reporting
company o
|
Class
Common
Stock, $.01 par value
|
Shares
outstanding
as
of April 30, 2009
1,506,407,068
|
PART
I
|
FINANCIAL
INFORMATION
|
3
|
Item 1.
|
Condensed
Consolidated Financial Statements
|
3 |
Condensed
Consolidated Statements of Operations
|
3 | |
Condensed
Consolidated Balance Sheets
|
4 | |
Condensed
Consolidated Statements of Cash Flows
|
5
|
|
Notes
to the Condensed Consolidated Financial Statements
|
6
|
|
Item 2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
30
|
Item 3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
55
|
Item 4.
|
Controls
and Procedures
|
56
|
PART
II
|
OTHER
INFORMATION
|
57
|
Item 1.
|
Legal
Proceedings
|
57
|
Item 1A.
|
Risk
Factors
|
57
|
Item 6.
|
Exhibits
|
57
|
SIGNATURE
|
58
|
Three
Months Ended
March
31,
|
||||||||
in
millions, except per share data
|
2009
|
2008
|
||||||
Net
sales
|
$ | 2,010 | $ | 2,046 | ||||
Cost
of products sold
|
607 | 580 | ||||||
Gross
profit
|
1,403 | 1,466 | ||||||
Operating
expenses:
|
||||||||
Selling,
general and administrative expenses
|
651 | 661 | ||||||
Research
and development expenses
|
257 | 244 | ||||||
Royalty
expense
|
46 | 46 | ||||||
Amortization
expense
|
128 | 143 | ||||||
Purchased
research and development
|
13 | |||||||
Gain
on divestitures
|
(250 | ) | ||||||
Restructuring
charges
|
23 | 29 | ||||||
Litigation-related
charges
|
287 | |||||||
1,392 | 886 | |||||||
Operating
income
|
11 | 580 | ||||||
Other
income (expense):
|
||||||||
Interest
expense
|
(102 | ) | (131 | ) | ||||
Other,
net
|
(6 | ) | 13 | |||||
(Loss)
income before income taxes
|
(97 | ) | 462 | |||||
Income
tax (benefit) expense
|
(84 | ) | 140 | |||||
Net
(loss) income
|
$ | (13 | ) | $ | 322 | |||
Net
(loss) income per common share — basic
|
$ | (0.01 | ) | $ | 0.22 | |||
Net
(loss) income per common share — assuming dilution
|
$ | (0.01 | ) | $ | 0.21 | |||
Weighted-average shares
outstanding
|
||||||||
Basic
|
1,504.8 | 1,494.1 | ||||||
Assuming
dilution
|
1,504.8 | 1,500.1 |
March
31,
|
December
31,
|
|||||||
in
millions, except share data
|
2009
|
2008
|
||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 897 | $ | 1,641 | ||||
Trade
accounts receivable, net
|
1,369 | 1,402 | ||||||
Inventories
|
852 | 853 | ||||||
Deferred
income taxes
|
864 | 911 | ||||||
Prepaid
expenses and other current assets
|
592 | 645 | ||||||
Total
current assets
|
4,574 | 5,452 | ||||||
Property,
plant and equipment, net
|
1,708 | 1,728 | ||||||
Goodwill
and other intangible assets, net
|
19,539 | 19,665 | ||||||
Other
long-term assets
|
284 | 294 | ||||||
$ | 26,105 | $ | 27,139 | |||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Current
debt obligations
|
$ | 5 | $ | 2 | ||||
Accounts
payable
|
254 | 239 | ||||||
Accrued
expenses
|
2,014 | 2,612 | ||||||
Other
current liabilities
|
158 | 380 | ||||||
Total
current liabilities
|
2,431 | 3,233 | ||||||
Long-term
debt
|
6,242 | 6,743 | ||||||
Deferred
income taxes
|
2,245 | 2,262 | ||||||
Other
long-term liabilities
|
1,911 | 1,727 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders'
equity
|
||||||||
Preferred
stock, $ .01 par value - authorized 50,000,000 shares,
none issued and outstanding
|
||||||||
Common
stock, $ .01 par value - authorized 2,000,000,000 shares
and issued 1,506,323,486 shares as of March 31, 2009 and
1,501,635,679 shares as of December 31, 2008
|
15 | 15 | ||||||
Additional
paid-in capital
|
15,989 | 15,944 | ||||||
Accumulated
deficit
|
(2,745 | ) | (2,732 | ) | ||||
Other
stockholders' equity (deficit)
|
17 | (53 | ) | |||||
Total
stockholders' equity
|
13,276 | 13,174 | ||||||
$ | 26,105 | $ | 27,139 |
Three
Months Ended
March
31,
|
||||||||
(in
millions)
|
2009
|
2008
|
||||||
Cash
provided by operating activities
|
$ | 261 | $ | 266 | ||||
Investing
activities:
|
||||||||
Purchases
of property, plant and equipment
|
(60 | ) | (57 | ) | ||||
Proceeds
from sales of publicly traded and privately held equity securities
and collections
of notes receivable
|
50 | 37 | ||||||
Payments
for acquisitions of businesses, net of cash acquired
|
(4 | ) | ||||||
Payments
relating to prior period acquisitions
|
(502 | ) | (654 | ) | ||||
Proceeds
from business divestitures
|
1,300 | |||||||
Payments
for investments in companies and acquisitions of certain
technologies
|
(1 | ) | (6 | ) | ||||
|
||||||||
Cash (used
for) provided by investing activities
|
(517 | ) | 620 | |||||
Financing
activities:
|
||||||||
Payments
on long-term borrowings
|
(500 | ) | (625 | ) | ||||
Proceeds
from issuances of shares of common stock
|
12 | 26 | ||||||
Cash
used for financing activities
|
(488 | ) | (599 | ) | ||||
Net
(decrease) increase in cash and cash equivalents
|
(744 | ) | 287 | |||||
Cash
and cash equivalents at beginning of period
|
1,641 | 1,452 | ||||||
Cash
and cash equivalents at end of period
|
$ | 897 | $ | 1,739 |
Cash
Flow Hedges
|
Amount
of Gain (Loss) Recognized in OCI
(Effective
Portion)
|
Amount
of Gain (Loss) Reclassified from AOCI into Earnings
(Effective
Portion)
|
Location
in
Statement
of
Operations
|
Amount
of Gain (Loss) Recognized in Earnings on
Ineffective
Portion and Amount Excluded from Effectiveness Testing (*)
|
Location
in
Statement
of
Operations
|
|||||||||
Interest
rate swap contracts
|
$ | (2 | ) | $ | (10 | ) *** |
Interest
expense
|
$ | (2 | ) ** |
Interest
expense
|
|||
Foreign
exchange contracts
|
128 | 16 |
Cost
of products sold
|
Cost
of products sold
|
||||||||||
$ | 126 | $ | 6 | $ | (2 | ) |
*
Other than described in ** below, the amount of gain (loss)
recognized in earnings related to the ineffective portion of hedging
relationships was de minimis in the first quarter of
2009.
|
|||||||
**
During the first quarter of 2009, we prepaid $500 million of our term
loan, and recognized $2 million of ineffectiveness in accordance with
Statement No. 133 on interest rate swaps for which there was no longer an
underlying exposure.
|
|||||||
***
We had $8 million of gains recorded in AOCI as of March 31, 2009 related
to floating-to-fixed treasury locks terminated during 2005 and
2006. We recognized less than $1 million as a reduction in
interest expense during the first quarter of 2009 related to these
instruments.
|
Derivatives
Not Designated
as
Hedging Instruments
|
Amount
of Gain
Recognized
in
Income
|
Location
in
Statement of
Operations
|
|||
Foreign
exchange contracts
|
$ | 54 |
Other,
net
|
||
$ | 54 |
(in
millions)
|
Location
in
Balance
Sheet
|
Balance
as of
March
31, 2009
|
|||
Derivative
Assets:
|
|||||
Designated Hedging
Instruments
|
|||||
Currency
Exchange Contracts
|
Prepaid
expenses and other current assets
|
$ | 76 | ||
Currency
Exchange Contracts
|
Other
long-term assets
|
64 | |||
140 | |||||
Non-Designated Hedging
Instruments
|
|||||
Currency
Exchange Contracts
|
Prepaid
expenses and other current assets
|
32 | |||
$ | 172 | ||||
Derivative
Liabilities:
|
|||||
Designated Hedging
Instruments
|
|||||
Currency
Exchange Contracts
|
Other
current liabilities
|
$ | 19 | ||
Currency
Exchange Contracts
|
Other
long-term liabilities
|
12 | |||
Interest
Rate Swap Contracts
|
Other
current liabilities
|
29 | |||
Interest
Rate Swap Contracts
|
Other
long-term liabilities
|
9 | |||
69 | |||||
Non-Designated Hedging
Instruments
|
|||||
Currency
Exchange Contracts
|
Other
current liabilities
|
16 | |||
$ | 85 |
●
|
Level
1 – Inputs to the valuation methodology are quoted market prices for
identical assets or liabilities.
|
●
|
Level
2 – Inputs to the valuation methodology are other observable inputs,
including quoted market prices for similar assets or liabilities and
market-corroborated inputs.
|
●
|
Level
3 – Inputs to the valuation methodology are unobservable inputs based on
management’s best estimate of inputs market participants would use in
pricing the asset or liability at the measurement date, including
assumptions about risk.
|
(in
millions)
|
Level
1
|
Level
2
|
Level
3
|
Total
|
|||||||||
Assets
|
|||||||||||||
Money
market funds
|
$ | 363 | $ | 363 | |||||||||
Available-for-sale
investments
|
1 | 1 | |||||||||||
Derivative
and hedging contracts
|
$ | 172 | 172 | ||||||||||
$ | 364 | $ | 172 | $ | 536 | ||||||||
Liabilities
|
|||||||||||||
Derivative
and hedging contracts
|
$ | 85 | $ | 85 | |||||||||
$ | 85 | $ | 85 |
March
31,
|
December
31,
|
|||||||
(in
millions)
|
2009
|
2008
|
||||||
Finished
goods
|
$ | 537 | $ | 555 | ||||
Work-in-process
|
143 | 135 | ||||||
Raw
materials
|
172 | 163 | ||||||
$ | 852 | $ | 853 |
March
31,
|
December
31,
|
|||||||
(in
millions)
|
2009
|
2008
|
||||||
Property,
plant and equipment
|
$ | 3,113 | $ | 3,110 | ||||
Less:
accumulated depreciation
|
1,405 | 1,382 | ||||||
$ | 1,708 | $ | 1,728 |
March
31,
|
December
31,
|
|||||||
(in
millions)
|
2009
|
2008
|
||||||
Goodwill
|
$ | 12,425 | $ | 12,421 | ||||
Core
technology
|
6,855 | 6,855 | ||||||
Other
intangible assets
|
2,379 | 2,381 | ||||||
21,659 | 21,657 | |||||||
Less:
accumulated amortization
|
2,120 | 1,992 | ||||||
$ | 19,539 | $ | 19,665 |
Balance
as of December 31, 2008
|
$ | 62 | ||
Provision
|
5 | |||
Settlements/
reversals
|
(10 | ) | ||
Balance
as of March 31, 2009
|
$ | 57 |
Payments
due by Period
|
||||||||||||||||||||||||||||
(in
millions)
|
2009
|
2010
|
2011
|
2012
|
2013
|
Thereafter
|
Total
|
|||||||||||||||||||||
Term
loan
|
$ | 325 | $ | 2,000 | $ | 2,325 | ||||||||||||||||||||||
Abbott
Laboratories loan
|
900 | 900 | ||||||||||||||||||||||||||
Senior
notes
|
850 | $ | 2,200 | 3,050 | ||||||||||||||||||||||||
$ | $ | 325 | $ | 3,750 | $ | $ | $ | 2,200 | $ | 6,275 |
|
Note:
|
The
table above does not include discounts associated with our Abbott loan and
senior notes, or amounts related to certain interest rate swaps that were
used to hedge the fair value of certain of our senior
notes.
|
Covenant
Requirement
|
Actual
as of
March
31, 2009
|
|
Maximum
leverage ratio (1)
|
4.0
to 1.0
|
2.9
to 1.0
|
Minimum
interest coverage ratio (2)
|
3.0
to 1.0
|
4.9
to 1.0
|
|
(1)
|
Ratio
of total debt to EBITDA, as defined by the agreement, as amended, for the
preceding four fiscal quarters. The maximum permitted leverage ratio steps
down to 3.5 to 1.0 on September 30,
2009.
|
|
(2)
|
Ratio
of EBITDA, as defined by the agreement, as amended, to interest expense
for the preceding four consecutive fiscal
quarters.
|
Type
of cost
|
Total
estimated amount expected to be incurred
|
Restructuring
charges:
|
|
Termination
benefits
|
$225
million to $230 million
|
Fixed
asset write-offs
|
$20
million
|
Other
(1)
|
$65
million to $70 million
|
Restructuring-related
expenses:
|
|
Retention
incentives
|
$75
million to $80 million
|
Accelerated
depreciation
|
$10
million to $15 million
|
Transfer
costs (2)
|
$30
million to $35 million
|
$425
million to $450
million
|
(1)
|
Consists
primarily of consulting fees and contractual
cancellations.
|
(2)
|
Consists
primarily of costs to transfer product lines among facilities, including
costs of transfer teams,freight and product line
validations.
|
Type
of cost
|
Total
estimated amount expected to be incurred
|
Restructuring
charges:
|
|
Termination
benefits
|
$45
million to $50 million
|
Restructuring-related
expenses:
|
|
Accelerated
depreciation
|
$15
million to $20 million
|
Transfer
costs (1)
|
$75
million to $80 million
|
$135
million to $150
million
|
(1)
|
Consists
primarily of costs to transfer product lines among facilities, including
costs of transfer teams, freight and product line
validations.
|
(in
millions)
|
Termination
Benefits
|
Retention
Incentives
|
Accelerated
Depreciation
|
Transfer
Costs
|
Other
|
Total
|
||||||||||||||||||
Restructuring
charges
|
$ | 18 | $ | 5 | $ | 23 | ||||||||||||||||||
Restructuring-related
expenses:
|
||||||||||||||||||||||||
Cost
of products sold
|
$ | 1 | $ | 2 | $ | 7 | 10 | |||||||||||||||||
Selling,
general and administrative expenses
|
3 | 3 | ||||||||||||||||||||||
Research
and development expenses
|
1 | 1 | ||||||||||||||||||||||
5 | 2 | 7 | 14 | |||||||||||||||||||||
$ | 18 | $ | 5 | $ | 2 | $ | 7 | $ | 5 | $ | 37 |
(in
millions)
|
Termination
Benefits
|
Retention
Incentives
|
Accelerated
Depreciation
|
Transfer
Costs
|
Other
|
Total
|
||||||||||||||||||
2007
Restructuring plan
|
$ | 3 | $ | 5 | $ | 1 | $ | 4 | $ | 5 | $ | 18 | ||||||||||||
Plant
Network Optimization plan
|
15 | 1 | 3 | 19 | ||||||||||||||||||||
$ | 18 | $ | 5 | $ | 2 | $ | 7 | $ | 5 | $ | 37 |
(in
millions)
|
Termination
Benefits
|
Retention
Incentives
|
Accelerated
Depreciation
|
Transfer
Costs
|
Other
|
Total
|
||||||||||||||||||
Restructuring
charges
|
$ | 20 | $ | 9 | $ | 29 | ||||||||||||||||||
Restructuring-related
expenses:
|
||||||||||||||||||||||||
Cost
of products sold
|
$ | 3 | $ | 1 | 4 | |||||||||||||||||||
Selling,
general and administrative expenses
|
6 | 3 | 9 | |||||||||||||||||||||
Research
and development expenses
|
2 | 2 | ||||||||||||||||||||||
11 | 4 | 15 | ||||||||||||||||||||||
$ | 20 | $ | 11 | $ | 4 | $ | $ | 9 | $ | 44 |
(in
millions)
|
2007
Restructuring
|
Plant
Network
Optimization
|
Total
|
|||||||||
Termination
benefits
|
$ | 195 | $ | 15 | $ | 210 | ||||||
Retention
incentives
|
53 | 53 | ||||||||||
Fixed
asset write-offs
|
18 | 18 | ||||||||||
Accelerated
depreciation
|
12 | 1 | 13 | |||||||||
Transfer
costs
|
8 | 3 | 11 | |||||||||
Other
|
49 | 49 | ||||||||||
$ | 335 | $ | 19 | $ | 354 |
2007
Restructuring
|
Plant
Network Optimization
|
|||||||||||||||||||
(in
millions)
|
Termination
Benefits
|
Other
|
Subtotal
|
Termination
Benefits
|
Total
|
|||||||||||||||
Charges
|
$ | 158 | $ | 10 | $ | 168 | $ | 168 | ||||||||||||
Cash
payments
|
(23 | ) | (8 | ) | (31 | ) | (31 | ) | ||||||||||||
Balance
as of December 31, 2007
|
135 | 2 | 137 | 137 | ||||||||||||||||
Charges
|
34 | 34 | 68 | 68 | ||||||||||||||||
Cash
payments
|
(128 | ) | (35 | ) | (163 | ) | (163 | ) | ||||||||||||
Balance
as of December 31, 2008
|
41 | 1 | 42 | 42 | ||||||||||||||||
Charges
|
3 | 5 | 8 | $ | 15 | 23 | ||||||||||||||
Cash
payments
|
(9 | ) | (5 | ) | (14 | ) | (14 | ) | ||||||||||||
Balance
as of March 31, 2009
|
$ | 35 | $ | 1 | $ | 36 | $ | 15 | $ | 51 |
Three
Months Ended
|
||||||||
March
31,
|
||||||||
(in
millions)
|
2009
|
2008
|
||||||
Net
(loss) income
|
$ | (13 | ) | $ | 322 | |||
Foreign
currency translation adjustment
|
(6 | ) | 10 | |||||
Net
change in derivative financial instruments
|
76 | (93 | ) | |||||
Net
change in equity investments
|
(7 | ) | ||||||
Other
|
(2 | ) | ||||||
Comprehensive
income
|
$ | 57 | $ | 230 |
Three
Months Ended
|
||||||||
March
31,
|
||||||||
(in
millions)
|
2009
|
2008
|
||||||
Weighted
average shares outstanding - basic
|
1,504.8 | 1,494.1 | ||||||
Net
effect of common stock equivalents
|
6.0 | |||||||
Weighted
average shares outstanding - assuming dilution
|
1,504.8 | 1,500.1 |
Three
Months Ended
|
||||||||
March
31,
|
||||||||
(in
millions)
|
2009
|
2008
|
||||||
Cost
of products sold
|
$ | 6 | $ | 6 | ||||
Selling,
general and administrative expenses
|
29 | 28 | ||||||
Research
and development expenses
|
10 | 7 | ||||||
45 | 41 | |||||||
Less:
Income tax benefit
|
(15 | ) | (12 | ) | ||||
$ | 30 | $ | 29 | |||||
Impact
on net (loss) income per common share - basic
|
$ | (0.02 | ) | $ | (0.02 | ) | ||
Impact
on net (loss) income per common share - assuming dilution
|
$ | (0.02 | ) | $ | (0.02 | ) |
Three
Months Ended
March
31,
|
Percentage
Point
Increase
|
|||||||||||
2009
|
2008
|
(Decrease)
|
||||||||||
Reported
tax rate
|
86.6%
|
30.3%
|
56.3%
|
|||||||||
Impact
of certain charges*
|
(65.6)%
|
(6.7)%
|
(58.9)%
|
Three
Months Ended
|
||||||||
March
31,
|
||||||||
(in
millions)
|
2009
|
2008
|
||||||
Net sales
|
||||||||
United
States
|
$ | 1,170 | $ | 1,117 | ||||
EMEA
|
473 | 457 | ||||||
Japan
|
207 | 211 | ||||||
Inter-Continental
|
168 | 156 | ||||||
Net
sales allocated to reportable segments
|
2,018 | 1,941 | ||||||
Sales
generated from divested businesses
|
4 | 32 | ||||||
Impact
of foreign currency fluctuations
|
(12 | ) | 73 | |||||
$ | 2,010 | $ | 2,046 | |||||
(Loss) income before income
taxes
|
||||||||
United
States
|
$ | 274 | $ | 280 | ||||
EMEA
|
228 | 217 | ||||||
Japan
|
116 | 126 | ||||||
Inter-Continental
|
78 | 75 | ||||||
Operating
income allocated to reportable segments
|
696 | 698 | ||||||
Manufacturing
operations
|
(106 | ) | (101 | ) | ||||
Corporate
expenses and currency exchange
|
(127 | ) | (67 | ) | ||||
Acquisition-,
divestiture-, litigation-, and restructuring- related
net (charges) credits
|
(324 | ) | 193 | |||||
Amortization
expense
|
(128 | ) | (143 | ) | ||||
11 | 580 | |||||||
Other
expense
|
(108 | ) | (118 | ) | ||||
$ | (97 | ) | $ | 462 |
·
|
Customers
|
·
|
Innovation
|
·
|
Quality
|
·
|
People
|
·
|
Financial
strength
|
·
|
$240
million ($287 million pre-tax) of litigation-related charges associated
with various litigation matters;
|
·
|
$26
million ($37 million pre-tax) of restructuring and restructuring-related
charges associated with our Plant Network Optimization and 2007
Restructuring plans; and
|
·
|
a
$63 million credit, on both a pre-tax and after-tax basis, for discrete
tax items related to certain tax positions associated with prior period
divestiture-related credits.
|
(in
millions)
|
Three
Months Ended
March
31, 2009
|
Three
Months Ended
March
31, 2008
|
||||||||||||||||||||||
U.S.
|
International
|
Total
|
U.S.
|
International
|
Total
|
|||||||||||||||||||
ICD
systems
|
$ | 312 | $ | 132 | $ | 444 | $ | 274 | $ | 137 | $ | 411 | ||||||||||||
Pacemaker
systems
|
84 | 61 | 145 | 82 | 72 | 154 | ||||||||||||||||||
CRM
products
|
396 | 193 | 589 | 356 | 209 | 565 | ||||||||||||||||||
Electrophysiology
products
|
29 | 8 | 37 | 29 | 9 | 38 | ||||||||||||||||||
Total
CRM
|
$ | 425 | $ | 201 | $ | 626 | $ | 385 | $ | 218 | $ | 603 |
·
|
our
ability to maintain the trust and confidence of the implanting physician
community, the referring physician community and prospective patients in
our technology;
|
·
|
future
product field actions or new physician advisories by us or our
competitors;
|
·
|
our
ability to successfully launch next-generation products and
technology;
|
·
|
the
successful conclusion and positive outcomes of on-going and future
clinical trials that may provide opportunities to expand indications for
use;
|
·
|
variations
in clinical results, reliability or product performance of our and our
competitors’ products;
|
·
|
delayed
or limited regulatory approvals and unfavorable reimbursement
policies;
|
·
|
our
ability to retain key members of our sales force and other key
personnel;
|
·
|
new
competitive launches; and
|
·
|
average
selling prices and the overall number of procedures
performed.
|
(in
millions)
|
Three
Months Ended
March
31, 2009
|
Three
Months Ended
March
31, 2008
|
||||||||||||||||||||||
U.S.
|
International
|
Total
|
U.S.
|
International
|
Total
|
|||||||||||||||||||
TAXUS®
|
$ | 132 | $ | 162 | $ | 294 | $ | 218 | $ | 192 | $ | 410 | ||||||||||||
PROMUS®
|
114 | 37 | 151 | 18 | 18 | |||||||||||||||||||
Drug-eluting
|
246 | 199 | 445 | 218 | 210 | 428 | ||||||||||||||||||
Bare-metal
|
16 | 28 | 44 | 26 | 36 | 62 | ||||||||||||||||||
$ | 262 | $ | 227 | $ | 489 | $ | 244 | $ | 246 | $ | 490 |
·
|
our
two drug-eluting stent platform
strategy;
|
·
|
the
broad and consistent long-term results of our TAXUS® clinical trials, and
the favorable results of the XIENCE V™/PROMUS®
stent system clinical trials to
date;
|
·
|
the
performance benefits of our current and future
technology;
|
·
|
the
strength of our pipeline of drug-eluting stent
products;
|
·
|
our
overall position in the worldwide interventional medicine market and our
experienced interventional cardiology sales force;
and
|
·
|
the
strength of our clinical, marketing and manufacturing
capabilities.
|
·
|
our
ability to successfully launch next-generation products and technology
features;
|
·
|
physician
and patient confidence in our current and next-generation technology,
including drug-eluting stent
technology;
|
·
|
changes
in drug-eluting stent penetration rates, the overall number of PCI
procedures performed, average number of stents used per procedure, and
average selling prices of drug-eluting stent
systems;
|
·
|
the
outcome of intellectual property
litigation;
|
·
|
variations
in clinical results or perceived product performance of our or our
competitors’ products;
|
·
|
delayed
or limited regulatory approvals and unfavorable reimbursement
policies;
|
·
|
our
ability to retain key members of our sales force and other key personnel;
and
|
·
|
changes
in FDA clinical trial data and post-market surveillance requirements and
the associated impact on new product launch schedules and the cost of
product approvals and compliance.
|
(in
millions)
|
Three
Months Ended
March
31, 2009
|
Three
Months Ended
March
31, 2008
|
||||||||||||||||||||||
U.S.
|
International
|
Total
|
U.S.
|
International
|
Total
|
|||||||||||||||||||
Endoscopy
|
$ | 122 | $ | 110 | $ | 232 | $ | 116 | $ | 113 | $ | 229 | ||||||||||||
Urology/Gynecology
|
83 | 21 | 104 | 77 | 23 | 100 | ||||||||||||||||||
$ | 205 | $ | 131 | $ | 336 | $ | 193 | $ | 136 | $ | 329 |
Change
|
||||||||||||||||
Three
Months Ended
|
As
Reported
|
Constant
|
||||||||||||||
March
31,
|
Currency
|
Currency
|
||||||||||||||
(in
millions)
|
2009
|
2008
|
Basis
|
Basis
|
||||||||||||
United
States
|
$ | 1,170 | $ | 1,117 | 5 | % | 5 | % | ||||||||
EMEA
|
446 | 507 | (12) | % | 3 | % | ||||||||||
Japan
|
243 | 222 | 9 | % | (2) | % | ||||||||||
Inter-Continental
|
147 | 168 | (13) | % | 6 | % | ||||||||||
International
|
836 | 897 | (7) | % | 2 | % | ||||||||||
Subtotal
|
2,006 | 2,014 | 0 | % | 4 | % | ||||||||||
Divested
Businesses
|
4 | 32 | N/A | N/A | ||||||||||||
Worldwide
|
$ | 2,010 | $ | 2,046 | (2) | % | 2 | % |
Change
|
||||||||||||||||
Three
Months Ended
|
As
Reported
|
Constant
|
||||||||||||||
March
31,
|
Currency
|
Currency
|
||||||||||||||
(in
millions)
|
2009
|
2008
|
Basis
|
Basis
|
||||||||||||
Interventional
Cardiology
|
$ | 738 | $ | 756 | (3) | % | 1 | % | ||||||||
Peripheral
Interventions
|
158 | 177 | (12) | % | (7) | % | ||||||||||
Cardiovascular
|
896 | 933 | (4) | % | 0 | % | ||||||||||
Neurovascular
|
87 | 92 | (5) | % | 0 | % | ||||||||||
Cardiac
Rhythm Management
|
589 | 565 | 4 | % | 9 | % | ||||||||||
Electrophysiology
|
37 | 38 | (3) | % | (1) | % | ||||||||||
Cardiac
Rhythm Management
|
626 | 603 | 4 | % | 8 | % | ||||||||||
Endoscopy
|
232 | 229 | 1 | % | 6 | % | ||||||||||
Urology/Gynecology
|
104 | 100 | 5 | % | 7 | % | ||||||||||
Endosurgery
|
336 | 329 | 2 | % | 7 | % | ||||||||||
Neuromodulation
|
61 | 57 | 8 | % | 9 | % | ||||||||||
Subtotal
|
2,006 | 2,014 | 0 | % | 4 | % | ||||||||||
Divested
Businesses
|
4 | 32 | N/A | N/A | ||||||||||||
Worldwide
|
$ | 2,010 | $ | 2,046 | (2) | % | 2 | % | ||||||||
Q1
2009 Net Sales as compared to Q1 2008
|
||||||||||||
Change
|
Estimated
|
|||||||||||
(in
millions)
|
As
Reported
Currency
Basis
|
Constant
Currency
Basis
|
Impact
of
Foreign
Currency
|
|||||||||
Interventional
Cardiology
|
$ | (18 | ) | $ | 11 | $ | (29 | ) | ||||
Peripheral
Interventions
|
(19 | ) | (12 | ) | (7 | ) | ||||||
Cardiovascular
|
(37 | ) | (1 | ) | (36 | ) | ||||||
Neurovascular
|
(5 | ) | 0 | (5 | ) | |||||||
Cardiac
Rhythm Management
|
24 | 51 | (27 | ) | ||||||||
Electrophysiology
|
(1 | ) | 0 | (1 | ) | |||||||
Cardiac
Rhythm Management
|
23 | 51 | (28 | ) | ||||||||
Endoscopy
|
3 | 15 | (12 | ) | ||||||||
Urology/Gynecology
|
4 | 7 | (3 | ) | ||||||||
Endosurgery
|
7 | 22 | (15 | ) | ||||||||
Neuromodulation
|
4 | 5 | (1 | ) | ||||||||
Subtotal
|
(8 | ) | 77 | (85 | ) | |||||||
Divested
Businesses
|
(28 | ) | (28 | ) | 0 | |||||||
Worldwide
|
$ | (36 | ) | $ | 49 | $ | (85 | ) |
Gross
profit margin - three months ended March 31, 2008
|
71.7
|
%
|
Shifts
in product sales mix
|
(2.5)
|
%
|
Net
impact of foreign currency
|
1.4
|
%
|
All
other
|
(0.8)
|
%
|
Gross
profit margin - three months ended March 31, 2009
|
69.8
|
%
|
Three
Months Ended March 31,
|
||||||||||||||||
2009
|
2008
|
|||||||||||||||
(in
millions)
|
$
|
%
of
Net
Sales
|
$
|
%
of
Net
Sales
|
||||||||||||
Selling,
general and administrative expenses
|
651 | 32.4 | 661 | 32.3 | ||||||||||||
Research
and development expenses
|
257 | 12.8 | 244 | 11.9 | ||||||||||||
Royalty
expense
|
46 | 2.3 | 46 | 2.2 |
Type
of cost
|
Total
estimated amount expected to be incurred
|
Restructuring
charges:
|
|
Termination
benefits
|
$225
million to $230 million
|
Fixed
asset write-offs
|
$20
million
|
Other
(1)
|
$65
million to $70 million
|
Restructuring-related
expenses:
|
|
Retention
incentives
|
$75
million to $80 million
|
Accelerated
depreciation
|
$10
million to $15 million
|
Transfer
costs (2)
|
$30
million to $35 million
|
$425
million to $450
million
|
(1)
|
Consists
primarily of consulting fees and contractual
cancellations.
|
(2)
|
Consists
primarily of costs to transfer product lines among facilities, including
costs of transfer teams,freight and product line
validations.
|
Type
of cost
|
Total
estimated amount expected to be incurred
|
Restructuring
charges:
|
|
Termination
benefits
|
$45
million to $50 million
|
Restructuring-related
expenses:
|
|
Accelerated
depreciation
|
$15
million to $20 million
|
Transfer
costs (1)
|
$75
million to $80 million
|
$135
million to $150
million
|
(1)
|
Consists
primarily of costs to transfer product lines among facilities, including
costs of transfer teams, freight
and product line
validations.
|
(in
millions)
|
Termination
Benefits
|
Retention
Incentives
|
Accelerated
Depreciation
|
Transfer
Costs
|
Other
|
Total
|
||||||||||||||||||
Restructuring
charges
|
$ | 18 | $ | 5 | $ | 23 | ||||||||||||||||||
Restructuring-related
expenses:
|
||||||||||||||||||||||||
Cost
of products sold
|
$ | 1 | $ | 2 | $ | 7 | 10 | |||||||||||||||||
Selling,
general and administrative expenses
|
3 | 3 | ||||||||||||||||||||||
Research
and development expenses
|
1 | 1 | ||||||||||||||||||||||
5 | 2 | 7 | 14 | |||||||||||||||||||||
$ | 18 | $ | 5 | $ | 2 | $ | 7 | $ | 5 | $ | 37 |
(in
millions)
|
Termination
Benefits
|
Retention
Incentives
|
Accelerated
Depreciation
|
Transfer
Costs
|
Other
|
Total
|
||||||||||||||||||
2007
Restructuring plan
|
$ | 3 | $ | 5 | $ | 1 | $ | 4 | $ | 5 | $ | 18 | ||||||||||||
Plant
Network Optimization plan
|
15 | 1 | 3 | 19 | ||||||||||||||||||||
$ | 18 | $ | 5 | $ | 2 | $ | 7 | $ | 5 | $ | 37 |
(in
millions)
|
Termination
Benefits
|
Retention
Incentives
|
Accelerated
Depreciation
|
Transfer
Costs
|
Other
|
Total
|
||||||||||||||||||
Restructuring
charges
|
$ | 20 | $ | 9 | $ | 29 | ||||||||||||||||||
Restructuring-related
expenses:
|
||||||||||||||||||||||||
Cost
of products sold
|
$ | 3 | $ | 1 | 4 | |||||||||||||||||||
Selling,
general and administrative expenses
|
6 | 3 | 9 | |||||||||||||||||||||
Research
and development expenses
|
2 | 2 | ||||||||||||||||||||||
11 | 4 | 15 | ||||||||||||||||||||||
$ | 20 | $ | 11 | $ | 4 | $ | $ | 9 | $ | 44 |
(in
millions)
|
2007
Restructuring
|
Plant
Network
Optimization
|
Total
|
|||||||||
Termination
benefits
|
$ | 195 | $ | 15 | $ | 210 | ||||||
Retention
incentives
|
53 | 53 | ||||||||||
Fixed
asset write-offs
|
18 | 18 | ||||||||||
Accelerated
depreciation
|
12 | 1 | 13 | |||||||||
Transfer
costs
|
8 | 3 | 11 | |||||||||
Other
|
49 | 49 | ||||||||||
$ | 335 | $ | 19 | $ | 354 |
Three
Months Ended
|
||||||||
March
31,
|
||||||||
(in
millions)
|
2009
|
2008
|
||||||
Interest
income
|
$ | 4 | $ | 17 | ||||
Foreign
currency (losses) gains
|
(6 | ) | 5 | |||||
Net
losses on investments and notes receivable
|
(6 | ) | ||||||
Other
|
(4 | ) | (3 | ) | ||||
$ | (6 | ) | $ | 13 |
Three
Months Ended
March
31,
|
Percentage
Point
Increase
|
|||||||||||
2009
|
2008
|
(Decrease)
|
||||||||||
Reported
tax rate
|
86.6
%
|
30.3
%
|
|
56.3 %
|
||||||||
Impact
of certain charges*
|
(65.6)%
|
(6.7)%
|
(58.9)%
|
March
31,
|
December
31,
|
|||||||
(in
millions)
|
2009
|
2008
|
||||||
Short-term
debt
|
$ | 5 | $ | 2 | ||||
Long-term
debt
|
6,242 | 6,743 | ||||||
Total
debt
|
6,247 | 6,745 | ||||||
Less:
cash and cash equivalents
|
897 | 1,641 | ||||||
Net
debt
|
$ | 5,350 | $ | 5,104 |
Three
Months Ended
March
31,
|
||||||||
(in
millions)
|
2009
|
2008
|
||||||
Cash
provided by operating activities
|
$ | 261 | $ | 266 | ||||
Cash
(used for) provided by investing activities
|
(517 | ) | 620 | |||||
Cash
used for financing activities
|
(488 | ) | (599 | ) |
Payments
due by Period
|
||||||||||||||||||||||||||||
(in
millions)
|
2009
|
2010
|
2011
|
2012
|
2013
|
Thereafter
|
Total
|
|||||||||||||||||||||
Term
loan
|
$ | 325 | $ | 2,000 | $ | 2,325 | ||||||||||||||||||||||
Abbott
Laboratories loan
|
900 | 900 | ||||||||||||||||||||||||||
Senior
notes
|
850 | $ | 2,200 | 3,050 | ||||||||||||||||||||||||
$ | $ | 325 | $ | 3,750 | $ | $ | $ | 2,200 | $ | 6,275 |
|
Note:
|
The
table above does not include discounts associated with our Abbott loan and
senior notes, or amounts related to certain interest rate swaps that were
used to hedge the fair value of certain of our senior
notes.
|
·
|
Our
estimates for the worldwide CRM market, the increase in the size of the
CRM market above existing levels and our ability to increase CRM net
sales;
|
·
|
The
overall performance of, and referring physician, implanting physician and
patient confidence in, our and our competitors’ CRM products and
technologies, including our COGNIS® CRT-D and TELIGEN® ICD systems and our
LATITUDE® Patient Management
System;
|
·
|
The
results of CRM clinical trials undertaken by us, our competitors or other
third parties;
|
·
|
Our
ability to successfully launch next-generation products and technology
features, including the INGENIO™ pacemaker
system;
|
·
|
Our
ability to grow sales of both new and replacement implant
units;
|
·
|
Our
ability to retain key members of our CRM sales force and other key
personnel;
|
·
|
Competitive
offerings in the CRM market and the timing of receipt of regulatory
approvals to market existing and anticipated CRM products and
technologies;
|
·
|
Our
ability to successfully and timely implement a direct sales model for our
CRM products in Japan; and
|
·
|
Our
ability to avoid disruption in the supply of certain components or
materials or to quickly secure additional or replacement components or
materials on a timely basis.
|
·
|
Volatility
in the coronary stent market, our estimates for the worldwide coronary
stent market, the recovery of the coronary stent market, our ability to
increase coronary stent net sales, competitive offerings and the timing of
receipt of regulatory approvals to market existing and anticipated
drug-eluting stent technology and other stent
platforms;
|
·
|
Our
ability to successfully launch next-generation products and technology
features;
|
·
|
Our
ability to maintain or expand our worldwide market positions through
reinvestment in our two drug-eluting stent
programs;
|
·
|
Our
ability to manage the mix of our PROMUS® stent system net sales relative
to our total drug-eluting stent net sales and to launch on-schedule a
next-generation everolimus-eluting stent system with gross profit margins
more comparable to our TAXUS® stent
system;
|
·
|
Our
share of the worldwide and U.S. drug-eluting stent markets, the
distribution of share within the coronary stent market in the U.S. and
around the world, the average number of stents used per procedure, average
selling prices, and the penetration rate of drug-eluting stent technology
in the U.S. and international
markets;
|
·
|
The
overall performance of, and continued physician confidence in, our and
other drug-eluting stent systems, our ability to adequately address
concerns regarding the perceived risk of late stent thrombosis, and the
results of drug-eluting stent clinical trials undertaken by us, our
competitors or other third parties;
|
·
|
Abbott’s
ability to obtain approval for its XIENCE V™
everolimus-eluting coronary stent system in Japan and Abbott’s payment to
us of the associated milestone
obligation;
|
·
|
Our
reliance on Abbott’s manufacturing capabilities and supply chain, and our
ability to align our PROMUS® stent system supply from Abbott with customer
demand;
|
·
|
Enhanced
requirements to obtain regulatory approval in the U.S. and around the
world and the associated impact on new product launch schedules and the
cost of product approval and
compliance;
|
·
|
Our
ability to manage inventory levels, accounts receivable, gross margins and
operating expenses and to react effectively to worldwide economic and
political conditions;
and
|
·
|
Our
ability to retain key members of our cardiology sales force and other key
personnel.
|
·
|
Any
conditions imposed in resolving, or any inability to resolve, our
corporate warning letter or other FDA matters, as well as risks generally
associated with our regulatory compliance and quality systems in the U.S.
and around the world;
|
·
|
Our
ability to minimize or avoid future FDA warning letters or field actions
relating to our products and the on-going inherent risk of potential
physician advisories or field actions related to medical
devices;
|
·
|
The
effect of our litigation, risk management practices, including
self-insurance, and compliance activities on our loss contingencies, legal
provision and cash flows;
|
·
|
The
impact of our stockholder derivative and class action, patent, product
liability, contract and other litigation, governmental investigations and
legal proceedings;
|
·
|
Costs
associated with our on-going compliance and quality activities and
sustaining organizations;
|
·
|
The
impact of increased pressure on the availability and rate of third-party
reimbursement for our products and procedures worldwide;
and
|
·
|
Legislative
or regulatory efforts to modify the product approval or reimbursement
process, including a trend toward demonstrating clinical outcomes,
comparative effectiveness and cost
efficiency.
|
·
|
Our
ability to complete planned clinical trials successfully, to obtain
regulatory approvals and to develop and launch products on a timely basis
within cost estimates, including the successful completion of in-process
projects from purchased research and
development;
|
·
|
Our
ability to manage research and development and other operating expenses
consistent with our expected net sales
growth;
|
·
|
Our
ability to develop next-generation products and technologies successfully
across all of our businesses, as well as our ability to develop products
and technologies successfully in our other
businesses;
|
·
|
Our
ability to fund and achieve benefits from our focus on internal research
and development and external alliances as well as our ability to
capitalize on opportunities across our
businesses;
|
·
|
Our
failure to succeed at, or our decision to discontinue, any of our growth
initiatives;
|
·
|
Our
ability to integrate the strategic acquisitions we have
consummated;
|
·
|
Our
ability to fund with cash or common stock any acquisitions or alliances,
or to fund contingent payments associated with these
alliances;
|
·
|
Our
ability to prioritize our internal research and development project
portfolio and our external investment portfolio to identify profitable
growth opportunities and keep expenses in line with expected revenue
levels, or our decision to sell, discontinue, write down or reduce the
funding of any of these projects;
|
·
|
The
timing, size and nature of strategic initiatives, market opportunities and
research and development platforms available to us and the ultimate cost
and success of these initiatives;
|
·
|
Our
ability to successfully identify, develop and market new products or the
ability of others to develop products or technologies that render our
products or technologies noncompetitive or
obsolete.
|
·
|
Dependency
on international net sales to achieve
growth;
|
·
|
Risks
associated with international operations, including compliance with local
legal and regulatory requirements as well as changes in reimbursement
practices and policies; and
|
·
|
The
potential effect of foreign currency fluctuations and interest rate
fluctuations on our net sales, expenses and resulting
margins.
|
·
|
Our
ability to implement, fund, and achieve timely and sustainable cost
improvement measures consistent with our expectations, including our 2007
Restructuring plan, intended to better align operating expenses with
expected revenue levels and reallocate resources to better support growth
initiatives, and our Plant Network Optimization plan, intended to improve
overall gross profit margins;
|
·
|
Our
ability to generate sufficient cash flow to fund operations, capital
expenditures, and strategic investments, as well as to effectively manage
our debt levels and covenant compliance and to minimize the impact of
interest rate fluctuations on our earnings and cash
flows;
|
·
|
Our
ability to access the public and private capital markets when desired and
to issue debt or equity securities on terms reasonably acceptable to
us;
|
·
|
Our
ability to resolve open tax matters favorably and recover substantially
all of our deferred tax assets; and
|
·
|
The
impact of examinations and assessments by domestic and international
taxing authorities on our tax provision, financial condition or results of
operations.
|
·
|
Risks
associated with significant changes made or to be made to our
organizational structure, or to the membership of our executive committee
or Board of Directors;
|
·
|
Risks
associated with our acquisition of Guidant, including, among other things,
the indebtedness we have incurred and the integration challenges we will
continue to face;
|
·
|
Our
ability to retain our key employees and avoid business disruption and
employee distraction as we execute our 2007 Restructuring and Plant
Network Optimization plans; and
|
·
|
Our
ability to maintain management focus on core business activities while
also concentrating on resolving the corporate warning letter and
implementing strategic initiatives, including our 2007 Restructuring and
Plant Network Optimization plans, in order to streamline our operations,
reduce our debt obligations and improve our gross
margins.
|
31.1
|
Certification
of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
31.2
|
Certification
of the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
32.1
|
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, President and
Chief Executive Officer
|
32.2
|
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Executive Vice
President – Finance and Information Systems and Chief Financial
Officer
|
BOSTON
SCIENTIFIC CORPORATION
|
|||
By:
|
/s/ Sam R. Leno | ||
Name: Sam R. Leno | |||
Title:
Chief Financial Officer and Executive Vice
President
- Finance and Information Systems
|
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