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| BSX > SEC Filings for BSX > Form 10-K on 22-Feb-2013 | All Recent SEC Filings |
22-Feb-2013
Annual Report
Year Ended December 31, 2012
Tax Impact per
in millions, except per share data Pre-Tax Impact After-Tax share
GAAP results $ (4,107 ) $ 39 $ (4,068 ) $ (2.89 )
Non-GAAP adjustments:
Goodwill and other intangible asset
impairment charges 4,492 (46 ) 4,446 3.15
Acquisition- and divestiture-related net
credits (50 ) 14 (36 ) (0.02 )
Restructuring-related charges 160 (38 ) 122 0.09
Litigation-related charges 192 (74 ) 118 0.08
Discrete tax items 2 2 -
Amortization expense 395 (46 ) 349 0.25
Adjusted results $ 1,082 $ (149 ) $ 933 $ 0.66
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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 in this Item 7 for a discussion of management's use of these non-GAAP financial measures.
Year Ended December 31, 2011
Tax Impact per
in millions, except per share data Pre-Tax Impact After-Tax share
GAAP results $ 642 $ (201 ) $ 441 $ 0.29
Non-GAAP adjustments:
Goodwill and other intangible asset
impairment charges 718 (5 ) 713 0.47
Acquisition- and divestiture-related net
credits (798 ) 229 (569 ) (0.37 )
Restructuring-related charges 129 (39 ) 90 0.06
Litigation-related charges 48 (18 ) 30 0.02
Discrete tax items (27 ) (27 ) (0.02 )
Amortization expense 421 (81 ) 340 0.22
Adjusted results $ 1,160 $ (142 ) $ 1,018 $ 0.67
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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 in this Item 7 for a discussion of management's use of these
non-GAAP financial measures.
Cash generated by operating activities was $1.260 billion in 2012, as compared
to $1.008 billion in 2011. Our operating cash flows in 2011 included
approximately $300 million of one-time litigation-related payments. Our cash
generated from operations continues to be a significant source of funds for
investing in our growth and returning value to shareholders by buying back
shares of our common stock, pursuant to our share repurchase authorizations
discussed in Note L - Stockholders' Equity to our 2012 consolidated financial
statements contained in Item 8 of this Annual Report. During 2012, we used
approximately $600 million of cash generated from operations to repurchase
approximately 105 million shares of our common stock, as compared to 2011 in
which approximately $492 million of cash generated from operations was used to
repurchase approximately 82 million shares of our common stock. As of
December 31, 2012, we had total debt of $4.256 billion, cash and cash
equivalents of $207 million and working capital of $1.250 billion. In February
2012, Moody's Investors Service upgraded our corporate credit rating to Baa3, an
investment-grade rating, with a stable outlook. We now hold investment-grade
ratings with all three major credit-rating agencies. We believe our investment
grade credit profile reflects the size and diversity of our product portfolio,
our leading share position in several of our served markets, our strong cash
flow, our solid financial fundamentals and our financial strategy.
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 $1.252 billion in 2012, as
compared to $1.187 billion in the 2011, an increase of $65 million, or five
percent. U.S. net sales of our Endoscopy products were $605 million in 2012, as
compared to $562 million in the prior year. Our international net sales were
$647 million in 2012, as compared to $625 million in 2011, and included a $19
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 $84 million, or seven percent, in 2012,
as compared to 2011. This performance was primarily 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
Conformite Europeenne (CE) Mark and U.S. Food and Drug Administration (FDA)
approval and is the first device-based asthma treatment approved by the FDA. In
the third quarter of 2012, the American Medical Association (AMA) Current
Procedural Terminology (CPT) editorial panel assigned category I CPT codes
specifically for bronchial thermoplasty beginning January 1, 2013. The Category
I CPT procedure codes are recognized by all public and private health insurance
payers in the United States, which will allow physicians and hospitals to seek
reimbursement for bronchial thermoplasty procedures. We believe these codes will
provide greater access to treatment for patients with poorly controlled severe
asthma, help facilitate claims processing and help private payers' approve
coverage for this form of treatment. 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.
During 2012, we saw growth in our Alair® System product line with worldwide net
sales of $11 million in 2012 as compared to approximately $4 million in 2011.
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 $774 million in
2012, as compared to $731 million in 2011, an increase of $43 million, or six
percent. Our U.S. net sales of these products were $340 million in 2012, as
compared to $310 million in 2011. Our international net sales were $434 million
in 2012, as compared to $421 million in 2011, and included a $13 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 $56 million, or eight percent, in 2012 as compared to 2011. The
year-over-year increase in worldwide PI net sales was primarily driven by growth
in our core PI franchise as the result of new product launches in stents,
balloons and chronic total occlusions (CTO) devices, which we expect to continue
to drive our future growth. We also recently announced the acquisition of Vessix
Vascular, Inc., a developer of catheter-based renal denervation systems for the
treatment of uncontrolled hypertension. Through the acquisition of Vessix we
added a second generation, highly differentiated technology to our hypertension
strategy, and we believe this technology will accelerate our entry into the
hypertension market. We expect to launch this technology commercially in Europe
and certain other international markets in 2013. We believe that offering these
devices will enhance our position in assisting physicians in addressing the
challenges of treating complex peripheral lesions.
Neuromodulation
Our Neuromodulation business offers the Precision® Spinal Cord Stimulation (SCS)
system, used for the management of chronic pain. Our worldwide net sales of
Neuromodulation products were $367 million in 2012, as compared to $336 million
in 2011, an increase of $31 million, or nine percent. Our U.S. net sales of
Neuromodulation products were $342 million in 2012, as compared to $317 million
in the prior year, and our international net sales of these products were $25
million in 2012 and $19 million in 2011. Excluding the negative impact of
changes in foreign currency exchange rates of $1 million, our Neuromodulation
worldwide net sales in 2012 grew nine percent as compared to the prior year. The
increase was primarily driven by U.S. net sales as a result of strong sales of
our Infinion™ 16 Percutaneous Lead, which received FDA approval in the fourth
quarter of 2011, and continued focus on commercial execution. During the third
quarter of 2012, we received CE Mark approval for use of our Vercise™ Deep Brain
Stimulation (DBS) System for the treatment of Parkinson's disease in Europe and
we expect to begin our U.S. pivotal study for the treatment of Parkinson's
disease 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.
In addition, during the fourth quarter of 2012 we received CE Mark approval for
the Precision Spectra™ Spinal Cord Stimulator (SCS) System. The Precision
Spectra System is the world's first and only SCS system with 32 contacts and 32
dedicated power sources and is designed to provide improved pain relief to a
wide range of patients who suffer from chronic pain.
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 $500 million in 2012, as compared to $498 million in 2011, an
increase of approximately $2 million, or less than one percent. Our U.S. net
sales were $355 million in 2012, as compared to $362 million in 2011. Our
international net sales were $145 million in 2012, as compared to $136 million
for the prior year, and included a $3 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
increased $5 million, or one percent, in 2012, as compared to 2011.
Our Urology business grew approximately five percent on strong sales execution
and continued commercial expansion. However, our Women's Health business
declined 11 percent primarily due to continued pressures on elective procedures
and lower sales levels 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.
Despite the recent performance of the Urology/Women's Health division, due
primarily to the market contraction as a result of the 2011 FDA release of a
Public Health Notice update, we believe that our Urology/Women's Health business
has the opportunity for growth as a result of our pipeline of upcoming product
launches and our plans to continue expanding the global footprint of this
business.
Electrophysiology
Our Electrophysiology business develops 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. Worldwide net
sales of our Electrophysiology products were $147 million in 2012 and 2011. Our
U.S. net sales of these products were $108 million in 2012, as compared to
$107 million in 2011. Our international net sales of these products were
$39 million in 2012 and $40 million in 2011 and included a negative impact from
changes in foreign currency exchange rates of $2 million. Excluding the impact
of changes in foreign currency exchange rates, our worldwide Electrophysiology
net sales, increased $2 million, or one percent, in 2012, as compared to 2011.
Additionally, on October 9, 2012, we acquired Rhythmia Medical, Inc., a
developer of next-generation mapping and navigation solutions for use in cardiac
catheter ablations and other electrophysiology procedures, including atrial
fibrillation and atrial flutter. We believe that this acquisition, as well as
our other expected product launches, will help to position us to competitively
participate in the fast-growing Electrophysiology market. In January 2013, the
first patient was enrolled in the ZERO AF clinical trial to evaluate the safety
and effectiveness of the Blazer® Open-Irrigated Temperature Ablation Catheter in
patients with symptomatic, drug refractory paroxysmal atrial fibrillation. The
results of the ZERO AF trial are expected to be used to support a FDA regulatory
submission for a paroxysmal atrial fibrillation indication. The Blazer
Open-Irrigated Catheter is our first entry into the open-irrigated catheter
segment and is approved for use in CE Mark countries and Canada. The Blazer
Open-Irrigated Catheter offers the Total Tip Cooling™ design, engineered to
consistently cool the entire tip of the electrode during radiofrequency energy
delivery to treat many heart rhythm disorders including paroxysmal atrial
fibrillation.
Cardiac Rhythm Management
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. Worldwide net sales of our CRM products of $1.908 billion
represented approximately 26 percent of our consolidated net sales for 2012. Our
worldwide CRM net sales decreased $179 million, or nine percent, in 2012, as
compared to the prior year. Our U.S. CRM net sales decreased $114 million, or
nine percent, in 2012 as compared to 2011. Our international CRM net sales
decreased $65 million, or seven percent, in 2012, as compared to 2011, and
included a $34 million negative impact from changes in foreign currency exchange
rates. Excluding the impact of changes in foreign currency exchange rates our
2012 worldwide CRM net sales decreased $145 million, or seven percent, as
compared to 2011.
The following are the components of our worldwide CRM net sales:
Year Ended Year Ended
(in millions) December 31, 2012 December 31, 2011
U.S. International Total U.S. International Total
ICD systems $ 858 $ 521 $ 1,379 $ 949 $ 569 $ 1,518
Pacemaker systems 256 273 529 279 290 569
CRM products $ 1,114 $ 794 $ 1,908 $ 1,228 $ 859 $ 2,087
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The reduction in our CRM net sales during 2012 as compared to 2011, is primarily
due to the impact of average selling price pressures driven by governmental,
competitive and other pricing pressures, and lower procedural volumes as a
result of continued contraction in the U.S. ICD market due to a variety of
factors, including physician reaction to study results published by the Journal
of the American Medical Association in prior years regarding evidence-based
guidelines for ICD implants, U.S. Department of Justice (DOJ) investigations
into hospitals' ICD implant practices and the expansion of Medicare recovery
audits, as well as on-going physician alignment to hospitals. In addition, our
sales levels related to replacement procedures were lower than the prior year
due to historical product recalls and subsequent reductions in our denovo (first
time) ICD implants following these recalls. However, we believe that our U.S.
denovo ICD share increased throughout 2012 as a result of our INCEPTA™ and
ENERGEN™ line of defibrillators launched in the fourth quarter of 2011, and our
highly-reliable RELIANCE lead platform.
In the first half of 2012, we launched our INGENIO™ family of pacemaker systems
in the U.S. and EMEA, and 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). During the second quarter of 2012, we completed the
acquisition of Cameron Health, Inc. (Cameron). Cameron developed the world's
first and only commercially available subcutaneous implantable cardioverter
defibrillator - the S-ICD® System, which we believe is a differentiated
technology that will provide us the opportunity to both increase our market
share in the existing ICD market and expand that market over time. The S-ICD®
system has received CE Mark approval and is available in EMEA. In September 2012
we received FDA approval for the S-ICD® system and commenced a limited
commercial launch in the United States. We believe these recent product
developments will help to better position us within the CRM market.
Net sales from our CRM products represent a significant source of our overall
net sales. Therefore, increases or decreases in our CRM net sales could have a
significant impact on our results of our consolidated operations. Variables that
may impact the size of the CRM market and/or our share of that market include,
but are not limited to:
• the on-going impact of physician alignment to hospitals, government
investigations and audits of hospitals, and other market and economic
conditions on the overall number of procedures performed and average
selling prices;
• our ability to retain and attract key members of our CRM sales force and other key CRM personnel;
• the ability of CRM manufacturers to maintain the trust and confidence of the implanting physician community, the referring physician community and prospective patients in CRM technologies;
• future product field actions or new physician advisories issued by us or our competitors;
• our ability to timely and successfully acquire or develop and launch new or next-generation competitive products and technologies worldwide, in line with our commercialization strategies, including the S-ICD® system;
• new product launches by our competitors;
• variations in clinical results, reliability or product performance of our and our competitors' products; and
• delayed or limited regulatory approvals and unfavorable reimbursement policies.
During the third quarter of 2012, we recorded a goodwill impairment charge, primarily driven by the reduction in the estimated size of the U.S. CRM market and related adjustments to our business, and other competitive factors, which led to lower projected U.S. CRM results compared to prior forecasts. Additionally, during the second quarter of 2012, we recorded a goodwill impairment charge related to our EMEA business. The EMEA goodwill impairment charge was primarily driven by our revised projections for revenue growth in EMEA which were slightly lower than our previous estimates; which was primarily due to macro-economic factors and our performance in the European market. Refer to Results of Operations for further details.
Interventional Cardiology (Coronary Stent Systems)
We offer innovative products in the coronary stent market to treat coronary
artery disease. We market our internally-developed and self-manufactured PROMUS®
Element™ everolimus-eluting stent platform in all major markets worldwide, as
well as our TAXUS® paclitaxel-eluting stent line, including our third-generation
TAXUS® Element™ stent system. Beginning in the first quarter of 2013, we also
received CE Mark approval and launched our next-generation Promus PREMIER™
Everolimus-Eluting Platinum Chromium Coronary Stent System in Europe and other
select geographies. We are the only company in the industry to offer a two-drug
platform strategy with our paclitaxel-eluting and everolimus-eluting stent
system offerings, and we offer a broad range of stent sizes. During the fourth
quarter of 2012, we received CE Mark approval for the SYNERGY™
Everolimus-Eluting Platinum Chromium Coronary Stent System featuring an
ultra-thin abluminal (outer) bioabsorbable polymer coating. The SYNERGY Stent is
unique in that its proprietary polymer and everolimus drug coating dissipate by
three months. This innovation has the potential to improve post-implant vessel
healing and will eliminate long-term polymer exposure, a possible cause of late
adverse events. During the fourth quarter of 2012 we also enrolled the first
patient in the EVOLVE II clinical trial, which is designed to further assess the
safety and effectiveness of the SYNERGY Stent System and support U.S. FDA and
Japanese regulatory approvals for this technology.
Worldwide net sales of our coronary stent systems, with the inclusion of
bare-metal stent systems, was $1.363 billion or approximately 19 percent of our
consolidated net sales in 2012. Our worldwide net sales of these products
decreased $257 million, or 16 percent, in 2012, as compared to 2011. Excluding
the impact of changes in foreign currency exchange rates, which had a
$33 million negative impact on our coronary stent system net sales in 2012, as
compared to the prior year, net sales of these products decreased $224 million,
or 14 percent. Our U.S. net sales of drug-eluting stent systems decreased
$193 million, or 26 percent, in 2012, as compared to 2011. This decrease was
primarily related to lower market share due to competitive launches in 2012,
continued average selling price declines in the U.S. drug-eluting stent (DES)
market as a result of continued competitive pressures and declines in procedural
volumes. Our international drug-eluting stent system net sales decreased
$39 million, or five percent, in 2012, as compared to the previous year.
Excluding the impact of changes in foreign currency exchange rates, our
international drug-eluting stent system net sales decreased $11 million, or two
percent due to continued lower market share related to competitive launches.
During 2012, we substantially completed the conversion of our U.S. and
international drug-eluting stent system sales to our self-manufactured PROMUS®
Element™ and TAXUS® stent systems, which has positively impacted our gross
profit margins.
The following are the components of our worldwide coronary stent system sales:
Year Ended Year Ended
(in millions) December 31, 2012 December 31, 2011
U.S. International Total U.S. International Total
Drug-eluting $ 557 $ 720 $ 1,277 $ 750 $ 759 $ 1,509
Bare-metal 24 62 86 32 79 111
$ 581 $ 782 $ 1,363 $ 782 $ 838 $ 1,620
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Historically, the worldwide coronary stent market has been dynamic and highly competitive with significant market share volatility. In addition, in the ordinary course of our business, we conduct and participate in numerous clinical trials with a variety of study designs, patient populations and trial end points. Unfavorable or inconsistent clinical data from existing or future . . .
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