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| BSX > SEC Filings for BSX > Form 10-Q on 7-Aug-2012 | All Recent SEC Filings |
7-Aug-2012
Quarterly Report
Introduction
Boston Scientific Corporation is a worldwide developer, manufacturer and
marketer of medical devices that are used in a broad range of interventional
medical specialties. Our mission is to improve the quality of patient care and
the productivity of health care delivery through the development and advocacy of
less-invasive medical devices and procedures. This is accomplished through the
continuing refinement of existing products and procedures and the investigation
and development of new technologies that are least- or less-invasive, reducing
risk, trauma, procedure time and the need for aftercare; cost- and
comparatively-effective and, where possible, reduce or eliminate refractory drug
use. Our strategy is to lead global markets for less-invasive medical devices by
developing and marketing innovative products, services and therapies that
address unmet patient needs, provide superior clinical outcomes and demonstrate
proven economic value.
Financial Summary
Three Months Ended June 30, 2012
Our net sales for the second quarter of 2012 were $1.828 billion, as compared to
net sales of $1.975 billion for the second quarter of 2011, a decrease of
$147 million, or seven percent. Excluding the impact of changes in foreign
currency exchange rates, which had a $51 million negative impact on our second
quarter 2012 net sales as compared to the same period in the prior year, and net
sales from divested businesses of $11 million, our net sales decreased
$85 million, or four percent.1 Refer to Business and Market Overview for a
discussion of our net sales by business.
Our reported net loss for the second quarter of 2012 was $3.578 billion, or
$2.51 per share, driven primarily by a goodwill impairment charge related to our
Europe, Middle East and Africa (EMEA) business unit. Refer to Quarterly Results
for a discussion of this charge. Our reported results for the second quarter of
2012 included goodwill and other intangible asset impairment charges,
acquisition-related credits, divestiture-, restructuring-, and
litigation-related charges and amortization expense totaling $3.817 billion, or
$2.68 per share. Excluding these items, net income for the second quarter of
2012 was $239 million, or $0.17 per share.1 Our reported net income for the
second quarter of 2011 was $146 million, or $0.10 per share. Our reported
results for the second quarter of 2011 included an intangible asset impairment
charge, acquisition- and divestiture-related charges, restructuring-related
charges and amortization expense totaling $116 million, or $0.07 per share.
Excluding these items, net income for the second quarter of 2011 was
$262 million, or $0.17 per share.1 The following is a reconciliation of results
of operations prepared in accordance with U.S. GAAP to those adjusted results
considered by management. Refer to Quarterly Results for a discussion of each
reconciling item:
1 Sales growth rates that exclude the impact of changes in foreign currency exchange rates and net income and net income per share excluding certain items required by GAAP are not prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP). Refer to Additional Information for a discussion of management's use of these non-GAAP financial measures.
Three Months Ended June 30, 2012
Tax Impact per
in millions, except per share data Pre-Tax Impact After-Tax share
GAAP net (loss) income $ (3,618 ) $ 40 $ (3,578 ) $ (2.51 )
Non-GAAP adjustments:
Goodwill impairment charge 3,602 (23 ) 3,579 2.50 *
Intangible asset impairment charge 129 (19 ) 110 0.08 *
Acquisition-related credits (34 ) 13 (21 ) (0.01 ) *
Divestiture-related charges 1 1 0.00 *
Restructuring-related charges 33 (9 ) 24 0.02 *
Litigation-related net charges 69 (29 ) 40 0.03 *
Amortization expense 99 (15 ) 84 0.06 *
Adjusted net income $ 281 $ (42 ) $ 239 $ 0.17
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* Assumes dilution of 5.8 million shares for the three months ended June 30, 2012 for all or a portion of these non-GAAP adjustments.
Three Months Ended June 30, 2011
Tax Impact per
in millions, except per share data Pre-Tax Impact After-Tax share
GAAP net income $ 158 $ (12 ) $ 146 $ 0.10
Non-GAAP adjustments:
Intangible asset impairment charge 12 (3 ) 9 0.01
Acquisition-related net charges 7 (1 ) 6 0.00
Divestiture-related charges 1 1 0.00
Restructuring-related charges 30 (9 ) 21 0.01
Amortization expense 96 (17 ) 79 0.05
Adjusted net income $ 304 $ (42 ) $ 262 $ 0.17
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Cash provided by operating activities was $407 million in the second quarter of 2012, as compared to $390 million in the second quarter of 2011. Our operating cash flows in the second quarter of 2012 included collections of approximately $60 million of our outstanding receivables in Spain as a result of a government-funded settlement. Our cash generated from operations continues to be a significant source of available funds for investing in our growth and buying back shares of our common stock pursuant to our share repurchase authorizations. During the second quarter of 2012, we used approximately $110 million of cash generated from operations to repurchase approximately 18 million shares of our common stock. We also paid $134 million, net of cash acquired, related to our acquisition of Cameron Health. As of June 30, 2012, we had total debt of $4.257 billion, cash and cash equivalents of $371 million and working capital of $1.317 billion. Refer to Liquidity and Capital Resources for further discussion.
Six Months Ended June 30, 2012
Our net sales for the first half of 2012 were $3.694 billion, as compared to net
sales of $3.900 billion for the first half of 2011, a decrease of $206 million,
or five percent. Excluding the impact of changes in foreign currency exchange
rates, which had a $56 million negative impact on our net sales for the six
months ended June 30, 2012 as compared to the same period in the prior year, and
net sales from divested businesses of $17 million, our net sales decreased
$133 million, or four percent.1 Refer to Business and Market Overview for a
discussion of our net sales by business.
Our reported net loss for the first half of 2012 was $3.465 billion, or $2.42
per share, driven primarily by a goodwill impairment charge related to our EMEA
business unit. Refer to Quarterly Results for a discussion of this charge. Our
reported results for the first half of 2012 included goodwill and other
intangible asset impairment charges, acquisition-related credits, divestiture-,
restructuring-, and litigation-related charges and amortization expense totaling
$3.924 billion, or $2.74 per share. Excluding these items, net income for the
first half of 2012 was $459 million, or $0.32 per share.1 Our reported net
income for the first half of 2011 was $192 million, or $0.12 per share. Our
reported results for the first half of 2011 included goodwill and other
intangible asset impairment charges, acquisition- and divestiture-related net
credits, restructuring-related charges, discrete tax items and amortization
expense totaling $406 million, or $0.27 per share. Excluding these items, net
income for the first half of 2011 was $598 million, or $0.39 per share.1 The
following is a reconciliation of results of operations prepared in accordance
with U.S. GAAP to those adjusted results considered by management. Refer to
Quarterly Results for a discussion of each reconciling item:
1 Sales growth rates that exclude the impact of changes in foreign currency exchange rates and net income and net income per share excluding certain items required by GAAP are not prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP). Refer to Additional Information for a discussion of management's use of these non-GAAP financial measures.
Six Months Ended June 30, 2012
Tax Impact per
in millions, except per share data Pre-Tax Impact After-Tax share
GAAP net (loss) income $ (3,495 ) $ 30 $ (3,465 ) $ (2.42 )
Non-GAAP adjustments:
Goodwill impairment charge 3,602 (23 ) 3,579 2.49 *
Intangible asset impairment charge 129 (19 ) 110 0.08 *
Acquisition-related credits (21 ) 11 (10 ) (0.01 ) *
Divestiture-related charges 2 2 0.00 *
Restructuring-related charges 50 (13 ) 37 0.03 *
Litigation-related net charges 69 (29 ) 40 0.03 *
Amortization expense 195 (29 ) 166 0.12 *
Adjusted net income $ 531 $ (72 ) $ 459 $ 0.32
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* Assumes dilution of 7.3 million shares for the six months ended June 30, 2012 for all or a portion of these non-GAAP adjustments.
Six Months Ended June 30, 2011
Tax Impact per
in millions, except per share data Pre-Tax Impact After-Tax share
GAAP net income $ 431 $ (239 ) $ 192 $ 0.12
Non-GAAP adjustments:
Goodwill impairment charge 697 697 0.45
Intangible asset impairment charge 12 (3 ) 9 0.00
Acquisition-related net credits (22 ) (1 ) (23 ) (0.01)
Divestiture-related net credits (758 ) 228 (530 ) (0.34)
Restructuring-related charges 80 (24 ) 56 0.04
Discrete tax items 4 4 0.00
Amortization expense 228 (35 ) 193 0.13
Adjusted net income $ 668 $ (70 ) $ 598 $ 0.39
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Cash provided by operating activities was $619 million in the first half of 2012, as compared to $293 million in the first half of 2011. Our 2012 operating cash flows included collections of approximately $60 million of our outstanding receivables in Spain as a result of a government-funded settlement. Our 2011 operating cash flows included approximately $300 million of litigation-related payments in the first quarter of 2011. Our cash generated from operations continues to be a significant source of available funds for investing in growth and buying back shares of our common stock pursuant to our share repurchase authorizations. During the first half of 2012, we used approximately $250 million of cash generated from operations to repurchase approximately 41 million shares of our common stock, and $134 million of cash generated from operations to purchase Cameron Health, Inc.
Business and Market Overview
Endoscopy
Our Endoscopy division develops and manufactures devices to treat a variety of
medical conditions including diseases of the digestive and pulmonary systems.
Our worldwide net sales of these products were $311 million in the second
quarter of 2012, as compared to $298 million in the second quarter of 2011, an
increase of $13 million, or four percent. U.S. net sales of our Endoscopy
products were $151 million for the second quarter of 2012, as compared to $141
million for the same period in the prior year. Our international net sales were
$160 million for the second quarter of 2012, as compared to $157 million for the
second quarter of 2011, and included a $7 million negative impact from changes
in foreign currency exchange rates. Excluding the impact of changes in foreign
currency exchange rates, our worldwide Endoscopy net sales increased $20
million, or seven percent, in the second
quarter of 2012, as compared to the second quarter of 2011. This performance was
the result of growth across several of our key product franchises, including our
biopsy business; our biliary device franchise driven by continued growth in our
Expect™ Endoscopic Ultrasound Aspiration Needle; our metal stent franchise
driven by our industry-leading WallFlex® product family, which now includes our
WallFlex® Biliary Transhepatic stent system for treatment of biliary strictures,
launched in the first quarter of 2012; and our hemostasis franchise on the
continued adoption and utilization of our Resolution Clip for gastrointestinal
bleeding.
In October 2010, we completed our acquisition of Asthmatx, Inc. Through
Asthmatx, we design, manufacture and market a less-invasive, catheter-based
bronchial thermoplasty procedure for the treatment of severe persistent asthma.
The Alair® Bronchial Thermoplasty System, developed by Asthmatx, has both CE
Mark and U.S. Food and Drug Administration (FDA) approval and is the first
device-based asthma treatment approved by the FDA. We continue to focus on
driving commercialization and increased awareness of the Alair® System. We
expect this technology to strengthen our existing offering of pulmonary devices
and contribute to future sales growth and diversification of the Endoscopy
business.
Peripheral Interventions (PI)
Our PI product offerings include stents, balloon catheters, wires, peripheral
embolization devices and other devices used to diagnose and treat peripheral
vascular disease. Our worldwide net sales of these products were $196 million in
the second quarter of 2012, as compared to $189 million in the second quarter of
2011, an increase of $7 million, or four percent. Our U.S. net sales of these
products were $86 million in the second quarter of 2012, as compared to
$80 million in the second quarter of 2011. Our international net sales were
$110 million in the second quarter of 2012, as compared to $109 million in the
second quarter of 2011, and included a $5 million negative impact from changes
in foreign currency exchange rates. Excluding the impact of changes in foreign
currency exchange rates, our worldwide PI net sales increased $12 million, or
seven percent, in the second quarter of 2012, as compared to the second quarter
of 2011. The year over year increase in worldwide PI net sales was driven by
growth in our core PI franchise following the recent launches of our
next-generation Mustang™ percutaneous transluminal angioplasty (PTA) balloon;
our Coyote™ balloon catheter, a highly deliverable and ultra-low profile balloon
dilatation catheter designed for a wide range of peripheral angioplasty
procedures; our Charger™ PTA Balloon Catheter, launched in the U.S. in December
2011; and our Gladiator™ Balloon Dilatation Catheter. In addition, our PI stent
systems continued to grow on the strength of the EPIC™ self-expanding nitinol
stent system in the U.S. and certain international markets and the Carotid
WALLSTENT® stent system in Japan. We launched the INNOVA™ self-expanding bare
metal stent system in certain international markets in the second quarter of
2012, and we believe this launch, in addition to a number of new PI products
expected to launch throughout the second half of 2012, will help to drive future
growth in this business.
In February 2011, we announced the acquisitions of S.I. Therapies and ReVascular
Therapeutics, Inc., which added to our PI portfolio a re-entry catheter and
intraluminal chronic total occlusion (CTO) crossing device, enabling
endovascular treatment in cases that typically cannot be treated with standard
endovascular devices. We commenced a limited market release of our OFFROAD™
re-entry catheter system in certain international markets, and in the first half
of 2012, we began the launch our TRUEPATH™ intraluminal CTO device in the U.S.,
EMEA and other international markets. We intend to expand the launch of our
OFFROAD™ system in certain international markets throughout 2012. We believe
that offering these devices will enhance our position in assisting physicians in
addressing the challenges of treating complex peripheral lesions.
Neuromodulation
Our worldwide net sales of Neuromodulation products were $91 million in the
second quarter of 2012, as compared to $84 million in the second quarter of
2011, an increase of $7 million, or nine percent. Our U.S. net sales of
Neuromodulation products were $85 million for the second quarter of 2012, as
compared to $78 million in the same period in the prior year, and our
international net sales of these products were $6 million in the second quarters
of 2012 and 2011. Changes in foreign currency exchange rates contributed a
negative $1 million to our Neuromodulation net sales in the second quarter of
2012, as compared to the same period in the prior year. Excluding the impact of
changes in foreign currency exchange rates, our worldwide Neuromodulation net
sales increased $8 million, or ten percent, in the second quarter of 2012, as
compared to the second quarter of 2011.The increase in U.S. net sales was due
primarily to higher procedural volumes and positive momentum from recent product
launches, including our Infinion™ lead. Within our Neuromodulation business, we
market the Precision® Plus™ Spinal Cord Stimulation (SCS) system, the world's
first rechargeable SCS device for chronic pain management. In the fourth quarter
of 2011, we received FDA approval for and launched the Infinion™ 16 Percutaneous
Lead, the world's first and only 16-contact percutaneous lead. With the addition
of the Infinion™ lead to our family of Linear percutaneous leads, the Precision
SCS® system offers physicians the broadest range of percutaneous lead
configurations in the industry for treating chronic pain patients. We believe
that we continue to have a technology advantage over our competitors with our
unique Smoothwave™ technology platform and proprietary features such as Multiple
Independent Current Control, which is intended to allow the physician to target
specific areas of pain more precisely.
We are looking to increase the clinical evidence supporting our spinal cord
stimulation technology and are committed to studies designed to demonstrate cost
effectiveness or demonstrate the value of proprietary features in our
SCS system. We expect to
complete our VANTAGE Study, a European clinical trial for the treatment of
Parkinson's Disease using our Vercise™ Deep Brain Stimulation (DBS) System, in
2013. We believe we have an exciting opportunity in DBS with our ability to
customize the field designed to precisely stimulate the target without
extraneous stimulation of adjacent areas that may cause unwanted side effects.
Urology/Women's Health
Our Urology/Women's Health division develops and manufactures devices to treat
various urological and gynecological disorders. Our worldwide net sales of these
products were $126 million in the second quarter of 2012, as compared to
$127 million in the second quarter of 2011, a decrease of $1 million, or
one percent. Our U.S. net sales were $89 million for the second quarter of 2012,
as compared to $93 million in the second quarter of 2011. Our international net
sales were $37 million in the second quarter of 2012, as compared to $34 million
for the same period in the prior year, and included a $1 million negative impact
from changes in foreign currency exchange rates. Excluding the impact of changes
in foreign currency exchange rates, our worldwide Urology/Women's Health net
sales remained flat in the second quarter of 2012, as compared to the second
quarter of 2011.
Our Urology business continued to experience strong growth in the United States
and internationally due to the strength of our Stone Management franchise.
During the first quarter of 2012, we began a full launch in the U.S. and certain
international markets of our BackStop® gel, designed to prevent stone migration
during stone management procedures.
In the second quarter of 2012, as compared to the same period in the prior year,
our Women's Health business continued to be negatively impacted by elective
procedural softness and reduced sales following the FDA release of a Public
Health Notice update in July 2011 regarding complications related to the use of
urogynecologic surgical mesh for pelvic organ prolapse and stress urinary
incontinence.
Electrophysiology
We develop less-invasive medical technologies used in the diagnosis and
treatment of rate and rhythm disorders of the heart. Our leading products
include the Blazer™ line of ablation catheters, designed to deliver enhanced
performance, responsiveness and durability. Our Blazer™ line includes our
next-generation Blazer™ Prime ablation catheter, and our Blazer™ Open-Irrigated
Catheter, launched in select European countries, which represents our latest
radiofrequency ablation catheter designed to treat a variety of arrhythmias.
Worldwide net sales of our Electrophysiology products were $37 million in the
second quarter of 2012, as compared to $38 million in the second quarter of
2011, a decrease of $1 million, or two percent. Our U.S. net sales of these
products were $28 million in the second quarters of 2012 and 2011. Our
international net sales of these products were $9 million in the second quarter
of 2012, as compared to $10 million for the same period in the prior year, and
included a $1 million negative impact from changes in foreign currency exchange
rates. Excluding the impact of changes in foreign currency exchange rates, our
worldwide Electrophysiology net sales remained flat in the second quarter of
2012, as compared to the second quarter of 2011.
In the first half of 2012, we launched in the U.S. and our EMEA region our
HeartSpan™ fixed sheath and Z Flex-270™ steerable sheath, both designed to
facilitate the introduction and placement of catheters for atrial fibrillation
within the heart. We believe these and other upcoming product launches, as well
as increasing adoption of our Blazer™ line of ablation catheters positions us
well within the Electrophysiology market.
Cardiac Rhythm Management (CRM)
Our CRM division develops, manufactures and markets a variety of implantable
devices including implantable cardioverter defibrillator (ICD) systems and
pacemaker systems that monitor the heart and deliver electricity to treat
cardiac abnormalities. In 2011, we began the U.S. and EMEA launches of our
next-generation line of defibrillators, INCEPTA™, ENERGEN™ and PUNCTUA™, which
are among the world's smallest and thinnest high-energy devices and deliver
excellent longevity. This tiered product line includes new features designed to
improve functionality, diagnostic capability and ease of use and allows us to
compete in all segments of the market. Additionally, this next-generation of
defibrillators includes models with our 4-SITE lead delivery system which is
built off our highly reliable RELIANCE® lead platform. We received CE Mark and
FDA approval for our INGENIO™ family of pacemaker systems in the second quarter
of 2012 and began to launch this line in the U.S. and EMEA. These launches
represent our first new major pacemaker system technology introduction in over
ten years and we expect it to be the foundation for a series of low-voltage
pacemaker launches. The INGENIO™ system is designed for use with our LATITUDE®
remote patient monitoring system and includes features for advanced heart
failure diagnostics. In July 2012, we received CE Mark approval for use of our
INGENIO™ and ADVANTIO™ pacemakers in patients in need of a magnetic resonance
imaging (MRI) scan, which we believe represents a significant advancement to our
family of pacemaker devices. In the second quarter of 2012, we received FDA
approval for our INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps).
INVIVE™ is built on the same platform as our high voltage CRT-Ds, is enabled for
remote patient monitoring, and includes features that promote ease of use. Our
product offerings also include our COGNIS® cardiac resynchronization therapy
defibrillator (CRT-D) and TELIGEN® ICD systems and our ALTRUA® family of
pacemaker systems.
Worldwide net sales of our CRM products of $488 million represented approximately 27 percent of our consolidated net sales for the second quarter of 2012. Our worldwide CRM net sales decreased $56 million, or ten percent, in the second quarter of 2012, as compared to the second quarter of 2011. Excluding the impact of changes in foreign currency exchange rates, which had a $16 million negative impact on our second quarter 2012 CRM net sales as compared to the same period in the prior year, our CRM net sales decreased $40 million, or eight percent. Our U.S. CRM net sales decreased $31 million, or 10 percent, in the second quarter of 2012 as compared to the second quarter of 2011. The reduction in our CRM net sales during the second quarter of 2012 is primarily due to the impact of lower procedural volumes as a result of the contraction in the U.S. ICD market in 2011, due to the factors discussed in our 2011 Annual Report filed on Form 10-K. Although we believe many of these factors are subsiding and we believe procedural volumes are beginning to stabilize, there can be no assurance we won't experience additional market declines in the future. However, we believe that the recent launches of our next-generation line of defibrillators, and the U.S. launches of our INGENIO™ pacemaker system and INVIVE™ CRT-Ps in the second quarter of 2012, will help enhance our position in the U.S. CRM market. Our international CRM net sales decreased $25 million, or 11 percent, in the second quarter of 2012, as compared to the second quarter of 2011. Excluding the impact of changes in foreign currency exchange rates, which had a $16 million negative impact on net sales in the second quarter of 2012, as compared to the . . .
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