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ABBOTT LABORATORIES - 10-K - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(Edgar Glimpses Via Acquire Media NewsEdge) Financial Review
Abbott's revenues are derived primarily from the sale of a broad line of
health care products under short-term receivable arrangements. Patent protection
and licenses, technological and performance features, and inclusion of Abbott's
products under a contract or by a pharmacy benefit manager most impact which
products are sold; price controls, competition and rebates most impact the net
selling prices of products; and foreign currency translation impacts the
measurement of net sales and costs. Abbott's primary products are nutritional
products, prescription pharmaceuticals, diagnostic testing products and vascular
products.
In October 2011, Abbott announced a plan to separate into two publicly
traded companies, one in diversified medical products and the other in
research-based pharmaceuticals. To accomplish the separation, Abbott created a
new company, AbbVie Inc. ("AbbVie") for its research-based pharmaceuticals
business which consists primarily of Abbott's Proprietary Pharmaceutical
Products segment. On January 1, 2013, Abbott distributed all of the outstanding
shares of AbbVie to Abbott's shareholders. As a result of the distribution,
AbbVie is now an independent company trading under the symbol "ABBV". Beginning
in the first quarter of 2013, the historical results of the research-based
pharmaceuticals business will be reflected in Abbott's consolidated financial
statements as discontinued operations.
Prior to the separation of AbbVie, sales in international markets were
approximately 60 percent of consolidated net sales. Post-separation, sales
outside the U.S. are expected to comprise approximately 70 percent of net sales.
Continued robust growth of HUMIRA in a broad range of indications, the
acquisitions of Solvay's pharmaceuticals business (Solvay Pharmaceuticals) and
Piramal Healthcare Limited's Healthcare Solutions business, sales growth and
margin improvement in the nutritional and diagnostics businesses, a government
investigation of Abbott's sales and marketing activities related to Depakote,
and the challenging economic and fiscal environment in many countries around the
world have impacted Abbott's sales, costs and financial position over the last
three years.
Pharmaceutical research and development was focused over the last three
years on therapeutic areas that included immunology, oncology, neuroscience,
pain management, hepatitis C (HCV), chronic kidney disease and women's health.
In addition, Abbott acquired the rights to various in-process pharmaceutical
research and development projects including the development of second-generation
oral antioxidant inflammation modulators and an oral, next-generation JAK1
inhibitor with the potential to treat multiple autoimmune diseases.
In 2003, Abbott began the worldwide launch of HUMIRA for rheumatoid
arthritis, followed by launches for six additional indications in the U.S. and
eight additional indications in the European Union. HUMIRA's worldwide sales
increased to $9.3 billion in 2012 compared to $7.9 billion in 2011, and
$6.5 billion in 2010. Generic competition for TriCor began in the fourth quarter
of 2012. Austerity measures implemented by several European countries reduced
healthcare spending and affected pharmaceutical pricing over the last three
years. The U.S. proprietary pharmaceuticals business was negatively affected by
the 2010 U.S. health care reform legislation which resulted in rebate changes
beginning in 2010 and the payment of an annual fee beginning in 2011.
In February 2010, Abbott acquired Solvay Pharmaceuticals which provided
Abbott with a large and complementary portfolio of pharmaceutical products and
expanded Abbott's presence in key global emerging markets. The acquisition added
approximately $3.1 billion to Abbott's 2010 net sales, primarily outside the
U.S. In September 2010, Abbott completed the acquisition of Piramal's Healthcare
Solutions business, propelling Abbott to market leadership in the Indian
pharmaceutical market and further
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accelerating the company's growth in emerging markets. Abbott recorded expense
of approximately $262 million in 2012, $345 million in 2011 and $710 million in
2010 related to the integration of the Solvay business and restructuring plans
to streamline operations, improve efficiencies and reduce costs primarily in
certain Solvay sites and functions.
In May 2012, Abbott reached resolution of all Depakote-related federal
claims, Medicaid-related claims with 49 states and the District of Columbia, and
consumer protection claims with 45 states and the District of Columbia. Abbott
recorded charges related to this matter of $1.5 billion in 2011 and $100 million
in 2012, of which approximately $1.6 billion was paid in 2012.
In Abbott's worldwide nutritional products business, sales were positively
impacted by demographics such as an aging population and an increasing rate of
chronic disease in developed markets and the rise of a middle class in many
emerging markets, as well as by numerous new product introductions that
leveraged Abbott's strong brands. At the same time, manufacturing and
distribution process changes and other cost reductions drove margin improvements
across the business.
In Abbott's worldwide diagnostics business, margin improvement continued to
be a key focus and operating margins increased from 14.7 percent of sales in
2010 to 18.7 percent in 2012.
Over the last three years, Abbott continued to build its Xience drug-eluting
stent franchise with the receipt of approval to market Xience Xpedition in
various countries, including U.S. approval in the fourth quarter of 2012 as well
as the launches of Xience nano and Xience PRIME in the U.S. in 2011, and Xience
PRIME and Xience V in Japan in April 2012 and January 2010, respectively.
Xience, which includes Xience V, PRIME, nano and Xpedition, ended 2012 as the
market-leading drug eluting stent globally. In 2011, the third party distributor
of the Promus product began transitioning away from the product and that supply
agreement ended in 2012. The effect of the winding down of the agreement will
continue into the first quarter of 2013.
In 2010, the U.S. government passed health care reform legislation which
included an increase in Medicaid rebate rates and the extension of the rebate to
drugs provided through Medicaid managed care organizations beginning in 2010.
The legislation also imposed annual fees which pharmaceutical manufacturers
began paying in 2011 and medical device companies will begin paying in 2013, as
well as additional rebates related to the Medicare Part D "donut hole" beginning
in 2011. In addition to a 2010 one-time charge of approximately $60 million to
reduce deferred tax assets associated with retiree health care liabilities
related to the Medicare Part D retiree drug subsidy, the legislation's negative
impact on Abbott's performance grew from more than $200 million in 2010 to
approximately $400 million per year in 2011 and 2012. The $400 million annual
impact included approximately $100 million for the annual pharmaceutical
manufacturer fee. This fee is not tax-deductible and is included in selling,
general and administrative expenses. With the separation of AbbVie at the
beginning of 2013, Abbott no longer sells pharmaceutical products in the U.S.
and therefore is no longer subject to the annual pharmaceutical fee or the
additional rebates. Beginning in 2013, Abbott will begin paying the 2.3 percent
medical device tax under U.S. health care reform legislation. This tax will be
included in selling, general and administrative expenses and the amount of the
tax is not expected to be material.
In the fourth quarter of 2012, Abbott extinguished $7.7 billion of long-term
debt and incurred a charge of $1.35 billion related to the early repayment, net
of gains from the unwinding of interest rate swaps related to the debt. Abbott's
short- and long-term debt totaled $20.5 billion at December 31, 2012. This
balance includes $1 billion of short-borrowings and $14.7 billion of long-term
debt that was issued by AbbVie Inc. in 2012. After the separation of AbbVie on
January 1, 2013, Abbott has no remaining obligations related to this
$15.7 billion of debt. At December 31, 2012, Abbott's long-term debt rating was
A+ by Standard and Poor's Corporation and A1 by Moody's Investors Service.
Operating cash flows in excess of capital expenditures and cash dividends have
partially funded acquisitions over the last three years.
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In 2013, Abbott will focus on several key initiatives. In the nutritional
business, Abbott will continue to build its product portfolio with the
introduction of new science-based products, expand in high-growth emerging
markets and implement additional margin improvement initiatives. In the
established pharmaceuticals business, which includes international sales of
branded generic products, Abbott will continue to focus on obtaining additional
product approvals across numerous countries and expanding its presence in
emerging markets. In the diagnostics business, Abbott will focus on the
development of next-generation instruments and other advanced technologies,
expansion in emerging markets, and further improvements in the segment's
operating margin. In the vascular business, Abbott will continue to focus on
marketing products in the Xience and endovascular franchises, increasing
international MitraClip sales, and obtaining regulatory review of the MitraClip
device in the U.S. as well as further clinical development of ABSORB, its
bioresorbable vascular scaffold (BVS) device and a further roll-out of ABSORB in
numerous countries. In Abbott's other segments, Abbott will focus on developing
differentiated technologies in higher growth markets.
Critical Accounting Policies
Sales Rebates - In 2012, approximately 56 percent of Abbott's consolidated
gross revenues were subject to various forms of rebates and allowances that
Abbott recorded as reductions of revenues at the time of sale. Most of these
rebates and allowances are in the Proprietary Pharmaceutical Products segment
and the Nutritional Products segment. Abbott provides rebates to pharmacy
benefit management companies, state agencies that administer the federal
Medicaid program, insurance companies that administer Medicare drug plans, state
agencies that administer the Special Supplemental Nutrition Program for Women,
Infants, and Children (WIC), wholesalers, group purchasing organizations, and
other government agencies and private entities. Rebate amounts are usually based
upon the volume of purchases using contractual or statutory prices for a
product. Factors used in the rebate calculations include the identification of
which products have been sold subject to a rebate, which customer or government
agency price terms apply, and the estimated lag time between sale and payment of
a rebate. Using historical trends, adjusted for current changes, Abbott
estimates the amount of the rebate that will be paid, and records the liability
as a reduction of gross sales when Abbott records its sale of the product.
Settlement of the rebate generally occurs from two to eight months after sale.
Abbott regularly analyzes the historical rebate trends and makes adjustments to
reserves for changes in trends and terms of rebate programs. Rebates and
chargebacks charged against gross sales in 2012, 2011 and 2010 amounted to
approximately $6.2 billion, $5.5 billion and $4.9 billion, respectively, or
22.9 percent, 22.2 percent and 23.1 percent, respectively, based on gross sales
of approximately $26.9 billion, $24.8 billion and $21.1 billion, respectively,
subject to rebate. A one-percentage point increase in the percentage of rebates
to related gross sales would decrease net sales by approximately $269 million in
2012. Abbott considers a one-percentage point increase to be a reasonably likely
increase in the percentage of rebates to related gross sales. Other allowances
charged against gross sales were approximately $542 million, $409 million and
$415 million for cash discounts in 2012, 2011 and 2010, respectively, and
$365 million, $490 million and $537 million for returns in 2012, 2011 and 2010,
respectively. Cash discounts are known within 15 to 30 days of sale, and
therefore can be reliably estimated. Returns can be reliably estimated because
Abbott's historical returns are low, and because sales returns terms and other
sales terms have remained relatively unchanged for several periods.
Management analyzes the adequacy of ending rebate accrual balances each
quarter. In the domestic nutritional business, management uses both internal and
external data available to estimate the level of inventory in the distribution
channel. Management has access to several large customers' inventory management
data, and for other customers, utilizes data from a third party that measures
time on the retail shelf. These sources allow management to make reliable
estimates of inventory in the distribution channel. Except for a transition
period before or after a change in the supplier for the WIC business in a state,
inventory in the distribution channel does not vary substantially. Management
also estimates the states' processing lag time based on claims data. In
addition, internal processing time is a factor in
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estimating the accrual. In the WIC business, the state where the sale is made,
which is the determining factor for the applicable price, is reliably
determinable. Estimates are required for the amount of WIC sales within each
state where Abbott has the WIC business. External data sources utilized for that
estimate are participant data from the U.S. Department of Agriculture (USDA),
which administers the WIC program, participant data from some of the states, and
internally administered market research. The USDA has been making its data
available for many years. Internal data includes historical redemption rates and
pricing data. At December 31, 2012, Abbott had WIC business in 22 states.
In the domestic proprietary pharmaceutical business, the most significant
charges against gross sales are for Medicaid and Medicare Rebates, Pharmacy
Benefit Manager Rebates and Wholesaler Chargebacks. In order to evaluate the
adequacy of the ending accrual balances, management uses both internal and
external data to estimate the level of inventory in the distribution channel and
the rebate claims processing lag time. External data sources used to estimate
the inventory in the distribution channel include inventory levels periodically
reported by wholesalers and third party market data purchased by Abbott.
Management estimates the processing lag time based on periodic sampling of
claims data. To estimate the price rebate percentage, systems and calculations
are used to track sales by product by customer and to estimate the contractual
or statutory price. Abbott's systems and calculations have developed over time
as rebates have become more significant, and Abbott believes they are reliable.
The following table is an analysis of the four largest rebate accruals,
which comprise approximately 70 percent of the consolidated rebate provisions
charged against revenues in 2012. Remaining rebate provisions charged against
gross sales are not significant in the determination of operating earnings.
(dollars in millions)
Domestic Proprietary Pharmaceutical Products
Domestic Medicaid and
Nutritionals Medicare Pharmacy Benefit Wholesaler
WIC Rebates Rebates Manager Rebates Chargebacks
Balance at
January 1,
2010 $ 153 $ 352 $ 239 $ 160
Provisions 616 899 841 1,162
Payments (640 ) (617 ) (670 ) (1,163 )
Balance at
December 31,
2010 129 634 410 159
Provisions 575 985 831 1,361
Payments (568 ) (899 ) (735 ) (1,349 )
Balance at
December 31,
2011 136 720 506 171
Provisions 657 1,077 830 1,645
Payments (670 ) (990 ) (840 ) (1,592 )
Balance at
December 31,
2012 $ 123 $ 807 $ 496 $ 224
Historically, adjustments to prior years' rebate accruals have not been
material to net income. Abbott employs various techniques to verify the accuracy
of claims submitted to it, and where possible, works with the organizations
submitting claims to gain insight into changes that might affect the rebate
amounts. For Medicaid, Medicare and other government agency programs, the
calculation of a rebate involves interpretations of relevant regulations, which
are subject to challenge or change in interpretation.
Income Taxes - Abbott operates in numerous countries where its income tax
returns are subject to audits and adjustments. Because Abbott operates globally,
the nature of the audit items are often very complex, and the objectives of the
government auditors can result in a tax on the same income in more than one
country. Abbott employs internal and external tax professionals to minimize
audit adjustment amounts where possible. In accordance with the accounting rules
relating to the measurement of tax contingencies, in order to recognize an
uncertain tax benefit, the taxpayer must be more likely than not of sustaining
the position, and the measurement of the benefit is calculated as the largest
amount that is more
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than 50 percent likely to be realized upon resolution of the benefit.
Application of these rules requires a significant amount of judgment. In the
U.S., Abbott's federal income tax returns through 2009 are settled except for
one item, and the income tax returns for years after 2009 are open. Abbott does
not record deferred income taxes on earnings reinvested indefinitely in foreign
subsidiaries.
Pension and Post-Employment Benefits - Abbott offers pension benefits and
post-employment health care to many of its employees. Abbott engages outside
actuaries to assist in the determination of the obligations and costs under
these programs. Abbott must develop long-term assumptions, the most significant
of which are the health care cost trend rates, discount rates and the expected
return on plan assets. The discount rates used to measure liabilities were
determined based on high-quality fixed income securities that match the duration
of the expected retiree benefits. The health care cost trend rates represent
Abbott's expected annual rates of change in the cost of health care benefits and
is a forward projection of health care costs as of the measurement date. A
difference between the assumed rates and the actual rates, which will not be
known for decades, can be significant in relation to the obligations and the
annual cost recorded for these programs. Low asset returns due to poor market
conditions and low interest rates have significantly increased actuarial losses
for these plans. At December 31, 2012, pretax net actuarial losses and prior
service costs and (credits) recognized in Accumulated other comprehensive income
(loss) for Abbott's defined benefit plans and medical and dental plans were
losses of $4.8 billion and $379 million, respectively. Actuarial losses and
gains are amortized over the remaining service attribution periods of the
employees under the corridor method, in accordance with the rules for accounting
for post-employment benefits. Differences between the expected long-term return
on plan assets and the actual annual return are amortized over a five-year
period. Note 4 to the consolidated financial statements describes the impact of
a one-percentage point change in the health care cost trend rate; however, there
can be no certainty that a change would be limited to only one percentage point.
Valuation of Intangible Assets - Abbott has acquired and continues to
acquire significant intangible assets that Abbott records at fair value.
Transactions involving the purchase or sale of intangible assets occur with some
frequency between companies in the health care field and valuations are usually
based on a discounted cash flow analysis. The discounted cash flow model
requires assumptions about the timing and amount of future net cash flows, risk,
the cost of capital, terminal values and market participants. Each of these
factors can significantly affect the value of the intangible asset. Abbott
engages independent valuation experts who review Abbott's critical assumptions
and calculations for acquisitions of significant intangibles. Abbott reviews
definite-lived intangible assets for impairment each quarter using an
undiscounted net cash flows approach. If the undiscounted cash flows of an
intangible asset are less than the carrying value of an intangible asset, the
intangible asset is written down to its fair value, which is usually the
discounted cash flow amount. Where cash flows cannot be identified for an
individual asset, the review is applied at the lowest group level for which cash
flows are identifiable. Goodwill and indefinite-lived intangible assets, which
relate to in-process research and development acquired in a business
combination, are reviewed for impairment annually or when an event that could
result in an impairment occurs. At December 31, 2012, goodwill and intangibles
amounted to $15.8 billion and $8.6 billion, respectively, and amortization
expense for intangible assets amounted to $1.4 billion in 2012. There were no
impairments of goodwill in 2012, 2011 or 2010. In 2012 and 2011, Abbott recorded
impairment charges of $82 million and $174 million, respectively, for certain
research and development assets due to changes in the projected development and
regulatory timelines for the projects.
Litigation - Abbott accounts for litigation losses in accordance with FASB
Accounting Standards Codification No. 450, "Contingencies." Under ASC No. 450,
loss contingency provisions are recorded for probable losses at management's
best estimate of a loss, or when a best estimate cannot be made, a minimum loss
contingency amount is recorded. These estimates are often initially developed
substantially earlier than the ultimate loss is known, and the estimates are
refined each accounting period as additional information becomes known.
Accordingly, Abbott is often initially unable to develop a best estimate of
loss, and therefore the minimum amount, which could be zero, is recorded. As
information becomes
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known, either the minimum loss amount is increased, resulting in additional loss
provisions, or a best estimate can be made, also resulting in additional loss
provisions. Occasionally, a best estimate amount is changed to a lower amount
when events result in an expectation of a more favorable outcome than previously
expected. Abbott estimates the range of possible loss to be from approximately
$70 million to $100 million for its legal proceedings and environmental
exposures. Accruals of approximately $80 million have been recorded at
December 31, 2012 for these proceedings and exposures. These accruals represent
management's best estimate of probable loss, as defined by FASB ASC No. 450,
"Contingencies."
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Results of Operations
Sales
The following table details the components of sales growth by reportable
segment for the last three years:
Total Components of Change %
% Change Price Volume Exchange
Total Net Sales
2012 vs. 2011 2.6 1.7 3.8 (2.9 )
2011 vs. 2010 10.5 1.2 6.5 2.8
2010 vs. 2009 14.3 (0.1 ) 13.2 1.2
Total U.S.
2012 vs. 2011 4.8 5.6 (0.8 ) -
2011 vs. 2010 5.4 4.4 1.0 -
2010 vs. 2009 6.8 0.7 6.1 -
Total International
2012 vs. 2011 1.1 (1.0 ) 7.1 (5.0 )
2011 vs. 2010 14.3 (1.2 ) 10.6 4.9
2010 vs. 2009 20.7 (0.8 ) 19.3 2.2
Proprietary Pharmaceutical Products
Segment
2012 vs. 2011 5.5 4.5 3.7 (2.7 )
2011 vs. 2010 11.0 3.5 5.2 2.3
2010 vs. 2009 13.6 0.3 12.7 0.6
Established Pharmaceutical Products
Segment
2012 vs. 2011 (4.4 ) (1.3 ) 3.4 (6.5 )
2011 vs. 2010 20.0 (1.7 ) 17.4 4.3
2010 vs. 2009 51.7 (0.3 ) 49.1 2.9
Nutritional Products Segment
2012 vs. 2011 7.7 4.5 4.2 (1.0 )
2011 vs. 2010 8.6 3.0 3.6 2.0
2010 vs. 2009 4.7 1.7 1.2 1.8
Diagnostic Products Segment
2012 vs. 2011 4.0 (1.4 ) 8.7 (3.3 )
2011 vs. 2010 8.8 (1.1 ) 6.5 3.4
2010 vs. 2009 6.0 0.1 4.3 1.6
Vascular Products Segment
2012 vs. 2011 (7.9 ) (5.2 ) (0.4 ) (2.3 )
2011 vs. 2010 4.4 (4.3 ) 5.5 3.2
2010 vs. 2009 18.6 (4.7 ) 22.3 1.0
Total Net Sales in 2012 reflect unit growth, partially offset by the impact
of unfavorable foreign exchange. The decrease in 2012 Vascular Products sales is
partially due to the winding down of royalty and supply agreements related to
certain third-party products, including Promus. Excluding this royalty and
supply agreement revenue in both periods and the unfavorable effect of exchange,
Vascular Products sales
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increased 3.4 percent in 2012. In 2011 and 2010, Total Net, Total U.S., Total
International, Proprietary Pharmaceutical Products segment and Established
Pharmaceutical Products segment sales reflect the acquisition of Solvay's
pharmaceuticals business on February 15, 2010 and unit growth, while the
relatively weaker U.S. dollar favorably impacted international sales across all
segments. Total Net, Total International and Established Pharmaceutical Products
segment sales growth in 2011 also reflects the acquisition of Piramal Healthcare
Limited's Healthcare Solution business in September 2010.
A comparison of significant product and product group sales is as follows.
Percent changes are versus the prior year and are based on unrounded numbers.
Percent Percent Percent
2012 Change 2011 Change 2010 Change
(dollars in millions)
Proprietary Pharmaceuticals -
Total U.S. Proprietary sales $ 10,158 7 $ 9,455 8 $ 8,744 12
HUMIRA 4,376 28 3,427 19 2,872 14
TRILIPIX/TriCor 1,098 (20 ) 1,372 1 1,355 1
Niaspan 911 (7 ) 976 5 927 8
AndroGel 1,152 32 874 35 649 n/m
Lupron 569 5 540 12 483 (11 )
Synthroid 551 6 522 16 451 9
Creon 353 7 332 35 246 n/m
Kaletra 280 (14 ) 326 (10 ) 363 (19 )
Total International
Proprietary sales 7,854 3 7,625 15 6,645 16
HUMIRA 4,889 9 4,505 23 3,676 24
Kaletra 733 (13 ) 844 (5 ) 892 (3 )
Lupron 231 (14 ) 270 2 265 2
Total Established
Pharmaceuticals - 5,121 (4 ) 5,355 20 4,461 52
Clarithromycin 501 (9 ) 551 6 521 (11 )
TriCor and Lipanthyl
(fenofibrate) 292 (5 ) 308 24 248 n/m
Creon 306 4 296 58 187 n/m
Serc 205 (12 ) 233 30 180 n/m
Duphaston 259 16 223 64 136 n/m
Synthroid 105 1 103 9 95 19
Nutritionals -
U.S. Pediatric Nutritionals 1,445 14 1,268 5 1,208 (7 )
International Pediatric
Nutritionals 2,080 8 1,926 15 1,676 9
U.S. Adult Nutritionals 1,452 6 1,368 2 1,345 6
International Adult
Nutritionals 1,484 4 1,427 13 1,268 15
Diagnostics -
Immunochemistry 3,279 4 3,150 8 2,904 4
Vascular Products (1) -
Xience 1,599 3 1,558 14 1,370 40
Other Coronary Products 598 (1 ) 605 9 555 5
Endovascular 452 1 449 9 414 5
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n/m - Percent change is not meaningful
º (1)
º Other Coronary Products include primarily guidewires and balloon catheters.
Endovascular includes vessel closure, carotid stents and other peripheral
products.
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Excluding the negative effect of exchange, Total International Proprietary
sales increased 8.9 percent in 2012. In Proprietary Pharmaceuticals, a generic
version of TriCor entered the U.S. market in the fourth quarter of 2012. Total
Established Pharmaceutical Products sales decreased in 2012 due to the negative
effect of exchange and decreased sales of Clarithromycin and Serc due to, in
part, pricing pressures in Europe, partially offset by growth in emerging
markets. Excluding the effect of exchange, Total Established Pharmaceutical
Products sales increased 2.1 percent. U.S. Pediatric Nutritional sales in 2012
reflect market share gains for Similac and unit growth for PediaSure. The
increase in 2012 U.S. Adult Nutritional sales reflects unit growth for the
Ensure and Glucerna products. International Pediatric and Adult Nutritionals
sales increases over the three years were due primarily to volume growth in
developing countries and were negatively impacted in 2012 by the effect of the
relatively stronger U.S. dollar.
The increases in U.S. Proprietary product sales in 2011 and 2010 are
primarily due to increased sales of HUMIRA and the acquisition of Solvay
Pharmaceuticals in February 2010, partially offset by decreased sales of
Depakote, Zemplar, and Kaletra. The increases in Established Pharmaceutical
sales in 2011 and 2010 are primarily due to the acquisitions of Solvay
Pharmaceuticals and Piramal and growth in emerging markets. U.S. Pediatric
Nutritionals sales in 2011 and 2010 were affected by the voluntary recall of
certain Similac-brand powder infant formulas in September 2010 and the
subsequent recovery in market share in 2011. International Proprietary
Pharmaceuticals, International Adult Nutritionals and Immunochemistry sales were
positively impacted by the effect of the relatively weaker U.S. dollar in 2011
and 2010. Abbott has periodically sold product rights to non-strategic products
and has recorded the related gains in net sales in accordance with Abbott's
revenue recognition policies as discussed in Note 1 to the consolidated
financial statements. Related net sales were approximately $58 million in 2010,
while there were no significant sales in 2012 and 2011.
The expiration of licenses and patent protection and generic competition can
affect the future revenues and operating income of Abbott. There are currently
no significant patent or license expirations in the next three years that are
expected to affect Abbott after the separation of AbbVie.
Operating Earnings
Gross profit margins were 62.1 percent of net sales in 2012, 60.0 percent in
2011 and 58.3 percent in 2010. The increase in the gross profit margin in 2012
was impacted by improved gross margins across all reportable segments as a
result of cost reduction initiatives, the impact of exchange and favorable
product mix. The increase in the gross profit margin in 2011 was due, in part,
to improved margins in the established pharmaceutical, diagnostics and diabetes
businesses and was partially offset by the unfavorable effect of exchange on the
profit margin ratio. The increase in the gross profit margin in 2010 was due, in
part, to improved margins in the established pharmaceutical, vascular, diabetes,
diagnostics and nutritional businesses and the favorable effect of exchange on
the gross profit margin ratio.
In the U.S., states receive price rebates from manufacturers of infant
formula under the federally subsidized Special Supplemental Nutrition Program
for Women, Infants, and Children. There are also rebate programs for
pharmaceutical products in numerous countries. These rebate programs continue to
have a negative effect on the gross profit margins of the Nutritional,
Proprietary Pharmaceutical and Established Pharmaceutical Products segments.
Research and development expense was $4.322 billion in 2012, $4.129 billion
in 2011 and $3.724 billion in 2010 and represented increases of 4.7 percent in
2012, 10.9 percent in 2011 and 35.7 percent in 2010. Excluding charges related
to the Solvay restructurings announced in September 2010, research and
development expense increased 6.2 percent in 2011 and 29.4 percent in 2010. The
2010 increase, exclusive of the effects of the restructuring charges, reflects
the acquisitions of Solvay's pharmaceuticals business in February 2010 and Facet
Biotech in April 2010. The increases in 2012, 2011 and 2010 also reflect
continued pipeline spending, including programs in biologics, hepatitis C and
diagnostics. The majority of research and development expenditures over the
three years were
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concentrated on pharmaceutical products. $2.9 billion of Abbott's 2012 research
and development expenses related to Abbott's pharmaceutical products, of which
$2.2 billion was directly allocated to the Proprietary Pharmaceutical Products
segment. In 2012, research and development expenditures totaled $367 million for
the Vascular Products segment, $382 million for the Diagnostics Products
segment, $275 million for the Established Pharmaceutical Products segment and
$186 million for the Nutritional Products segment.
Selling, general and administrative expenses decreased 5.5 percent in 2012
and increased 22.9 percent in 2011 and 23.4 percent in 2010. 2012 includes
approximately $405 million related to the separation of AbbVie from Abbott and a
$100 million litigation charge related to the government investigation related
to Depakote while 2011 includes a litigation charge of $1.5 billion related to
the Depakote investigation. Excluding separation costs, litigation charges and
Solvay-related restructuring and integration costs, selling, general and
administrative expenses increased 4.6 percent in 2012 and 6.7 percent in 2011.
Excluding charges related to Solvay restructuring and integration projects,
selling, general and administrative expenses in 2010 increased 18.2 percent.
This increase, exclusive of the effects of the restructuring and integration
charges, reflects the acquisitions of Solvay's pharmaceuticals business in 2010
and Advanced Medical Optics, Inc. in 2009 and higher provisions for litigation
in 2010. The remaining increases in selling, general and administrative expenses
over the three year period were due primarily to increased selling and marketing
support for new and existing products, including continued spending for HUMIRA,
inflation, and in 2011, the impact of the pharmaceutical fee imposed by U.S.
healthcare reform legislation.
Restructurings
In 2012, Abbott management approved plans to streamline various commercial
operations in order to reduce costs and improve efficiencies in Abbott's core
diagnostics, established pharmaceutical and nutritionals businesses. Abbott
recorded employee related severance charges of approximately $167 million in
2012. Additional charges of approximately $22 million were also recorded in
2012, primarily for asset impairments. Approximately $70 million is recorded in
Cost of products sold and approximately $119 million as Selling, general and
administrative expense. As of December 31, 2012, no significant cash payments
have been made relating to these actions.
In 2011 and prior years, Abbott management approved plans to realign its
worldwide pharmaceutical and vascular manufacturing operations and selected
domestic and international commercial and research and development operations in
order to reduce costs. In 2011 and 2010, Abbott recorded charges of
approximately $194 million and $56 million, respectively, reflecting the
impairment of manufacturing facilities and other assets, employee severance and
other related charges. Approximately $76 million in 2011 is classified as Cost
of products sold, $69 million as Research and development and $49 million as
Selling, general and administrative. Approximately $56 million in 2010 is
classified as Cost of products sold. The following summarizes the activity for
these restructurings: (dollars in millions)
Accrued balance at January 1, 2010 $ 145
2010 restructuring charges 56
Payments, impairments and other adjustments (124 )
Accrued balance at December 31, 2010 77
2011 restructuring charges 194
Payments, impairments and other adjustments (94 )
Accrued balance at December 31, 2011 177
Payments and other adjustments (48 )
Accrued balance at December 31, 2012 $ 129
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An additional $110 million, $25 million and $13 million were recorded in
2012, 2011 and 2010, respectively, relating to these restructurings, primarily
for accelerated depreciation.
In 2012 and 2010, Abbott management approved restructuring plans primarily
related to the acquisition of Solvay's pharmaceuticals business. These plans
streamline operations, improve efficiencies and reduce costs in certain Solvay
sites and functions as well as in certain Abbott and Solvay commercial
organizations in various countries. In 2012, Abbott recorded a charge of
approximately $150 million for employee severance and contractual obligations,
primarily related to the exit from a research and development facility.
Approximately $142 million is recorded as Research and development and
$8 million as Selling, general and administrative. In 2010, Abbott recorded
charges to Cost of products sold, Research and development and Selling, general
and administrative of approximately $99 million, $152 million and $272 million,
respectively. The following summarizes the activity for these restructurings:
(dollars in millions)
2010 restructuring charge $ 523
Payments, impairments and other adjustments (113 )
Accrued balance at December 31, 2010 410
Payments and other adjustments (302 )
Accrued balance at December 31, 2011 108
Restructuring charges 150
Payments and other adjustments (143 )
Accrued balance at December 31, 2012 $ 115
An additional $38 million, $102 million and $12 million were recorded in
2012, 2011 and 2010, respectively, relating to these restructurings, primarily
for additional employee severance and accelerated depreciation.
In 2011 and 2008, Abbott management approved plans to streamline global
manufacturing operations, reduce overall costs, and improve efficiencies in
Abbott's core diagnostic business. In 2011, a charge of $28 million was recorded
in Cost of products sold. The following summarizes the activity for these
restructurings: (dollars in millions)
Accrued balance at January 1, 2010 $ 98
Payments and other adjustments (10 )
Accrued balance at December 31, 2010 88
2011 restructuring charge 28
Payments and other adjustments (37 )
Accrued balance at December 31, 2011 79
Payments and other adjustments (23 )
Accrued balance at December 31, 2012 $ 56
In addition, charges of approximately $16 million, $42 million and
$60 million were recorded in 2012, 2011 and 2010, primarily for accelerated
depreciation and product transfer costs.
Interest expense and Interest (income)
In 2012, interest expense increased primarily due to bridge facility fees
related to the separation of AbbVie from Abbott. In 2011, interest expense
decreased due to lower debt levels. Interest income in 2012 and 2011 decreased
as a result of lower rates. In 2010, interest expense increased due primarily to
increased debt levels. Interest income decreased in 2010 due to lower investment
balances.
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Change in Accounting Principle and Other (income) expense, net
Prior to January 1, 2011, the accounts of foreign subsidiaries were
consolidated based on a fiscal year ended November 30 due to the time needed to
consolidate these subsidiaries. Effective January 1, 2011, the one month lag in
the consolidation of the accounts of foreign subsidiaries was eliminated and the
year-end of foreign subsidiaries was changed to December 31. Abbott believes
that the change in accounting principle related to the elimination of the one
month reporting lag is preferable because it results in more contemporaneous
reporting of the results of foreign subsidiaries. In accordance with applicable
accounting literature, a change in subsidiaries' year-end is treated as a change
in accounting principle and requires retrospective application. The cumulative
effect of the change was an increase in retained earnings of $289 million as of
January 1, 2009 and a corresponding decrease in other long-term liabilities. The
impact of the change was not material to the results of operations for the
previously reported annual and interim periods after January 1, 2009, and thus,
those results have not been revised. A charge of $137 million was recorded to
Other (income) expense, net in 2011 to recognize the cumulative immaterial
impacts to 2009 and 2010. Had the financial statements been revised, net sales,
operating earnings and net earnings in 2010 would have decreased by $21 million,
$195 million and $175 million, respectively.
Other (income) expense, net, for 2012 includes income of approximately
$60 million from the resolution of a contractual agreement and a loss of
approximately $62 million for the impairment of certain equity securities. Other
(income) expense, net, for 2011 includes $56 million of fair value adjustments
and accretion in the contingent consideration related to the acquisition of
Solvay's pharmaceutical business. Other (income) expense, net, for 2012, 2011
and 2010 also includes ongoing contractual payments from Takeda associated with
the conclusion of the TAP joint venture.
Net Loss on Extinguishment of Debt
In the fourth quarter of 2012, Abbott extinguished $7.7 billion of long-term
debt. Abbott incurred a cost of $1.35 billion to extinguish this debt, net of
gains from the unwinding of interest rate swaps related to the debt.
Taxes on Earnings
The income tax rates on earnings were 4.8 percent in 2012, 9.0 percent in
2011 and 19.0 percent in 2010. Taxes on earnings in 2012 reflect the
$493 million effect of the tax rate applied to Abbott's net debt extinguishment
loss as well as the recognition of $408 million of tax benefits as a result of
the favorable resolution of various tax positions pertaining to a prior year,
which also decreased the gross amount of unrecognized tax benefits by
approximately $560 million. Taxes on earnings in 2011 reflect the effect of the
tax rate applied to a litigation reserve and the recognition of $580 million of
tax benefits as a result of the favorable resolution of various tax positions
pertaining to prior years, which also decreased the gross amount of unrecognized
tax benefits by approximately $1.3 billion. Exclusive of these discrete items,
the effective rates are lower than the U.S. federal statutory rate of 35 percent
due primarily to the benefit of lower foreign tax rates and tax exemptions that
reduced the tax rates by 24.9, 22.9, and 19.4 percentage points in 2012, 2011
and 2010, respectively. The tax rate reductions are primarily derived from
operations in Puerto Rico, Switzerland, Ireland and Singapore where Abbott
benefits from a combination of favorable statutory tax rules, tax rulings,
grants, and exemptions. See Note 5 to the consolidated financial statements for
a full reconciliation of the effective tax rate to the U.S. federal statutory
rate.
As a result of the American Taxpayer Relief Act of 2012 signed into law in
January 2013, Abbott expects to record a tax benefit of approximately
$100 million in the first quarter of 2013 for the retroactive extension of the
research tax credit and the look-through rules of section 954(c)(6) of the
Internal Revenue Code to the beginning of 2012. Excluding this and any other
discrete items, Abbott expects to apply an annual effective rate of
approximately 21 percent.
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As a result of the Patient Protection and Affordable Care Act and the Health
Care and Education Reconciliation Act which were signed into law in 2010, Abbott
recorded a charge of approximately $60 million in 2010 to reduce deferred tax
assets associated with retiree health care liabilities related to the Medicare
Part D retiree drug subsidy.
In October 2010, Puerto Rico enacted legislation that assesses a tax
beginning in 2011 on certain products manufactured in Puerto Rico. The tax is
levied on gross intercompany purchases from Puerto Rican entities and is
included in inventory costs. In 2012 and 2011, cost of goods sold included
$187 million and $111 million, respectively, related to this tax. The tax is
creditable for U.S. income tax purposes.
Research and Development Programs
Abbott currently has numerous pharmaceutical, medical and nutritional
products in development.
Research and Development Process
In the Proprietary Pharmaceuticals segment, the research and development
process generally begins with discovery research which focuses on the
identification of a molecule that has a desired effect against a given disease.
If preclinical testing of an identified compound proves successful, the compound
moves into clinical development which generally includes the following phases:
º •
º Phase I - involves the first human tests in a small number of healthy
volunteers to assess tolerability and potential dosing.
º •
º Phase II - tests the molecule's efficacy against the disease in a
small group of patients.
º •
º Phase III - tests a molecule that demonstrates favorable results in
the earlier phases in a significantly larger patient population to
further demonstrate efficacy and safety based on regulatory criteria.
The clinical trials from all of the development phases provide the data
required to prepare and submit a New Drug Application (NDA), a Biological
License Application (BLA) or other submission for regulatory approval to the
U.S. Food and Drug Administration (FDA) or similar government agencies outside
the U.S. The specific requirements (e.g., scope of clinical trials) for
obtaining regulatory approval vary across different countries and geographic
regions.
The research and development process from discovery through a new drug
launch typically takes 8 - 12 years and can be even longer. There is a
significant amount of uncertainty inherent in the research and development of
new pharmaceutical products and there is no guarantee when, or if, a molecule
will receive the regulatory approval required to launch a new drug or
indication.
In addition to the development of new products and new formulations,
proprietary pharmaceutical research and development projects also may include
Phase IV trials, sometimes called post-marketing studies. For such projects,
clinical trials are designed and conducted to collect additional data regarding,
among other parameters, the benefits and risks of an approved drug.
In the Established Pharmaceuticals segment, the development process focuses
on the geographic expansion and continuous improvement of the segment's existing
products to provide benefits to patients and customers. As Established
Pharmaceuticals does not actively pursue primary research, development usually
begins with work on existing products or after the acquisition of an advanced
stage licensing opportunity.
Depending upon the product, the phases of development may include:
º •
º Drug product development
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º •
º Phase I bioequivalence studies to compare a future Established
Pharmaceutical's brand with an already marketed compound with the same
active pharmaceutical ingredient (API).
º •
º Phase II studies to test the efficacy of benefits in a small group of
patients.
º •
º Phase III studies to broaden the testing to a wider population that
reflects the actual medical use.
º •
º Phase IV and other post-marketing studies to obtain new clinical use
data on existing products within approved indications.
The specific requirements (e.g. scope of clinical trials) for obtaining
regulatory approval vary across different countries and geographic regions. The
process may range from one year for a bioequivalence study project to 6 or more
years for complex formulations, new indications, or geographic expansion in
specific countries such as China.
In the Diagnostics segment, the phases of the research and development
process include:
º •
º Discovery which focuses on identification of a product that will
address a specific therapeutic area, platform, or unmet clinical need,
º •
º Concept/Feasibility during which the materials and manufacturing
processes are evaluated, testing may include product characterization
and analysis is performed to confirm clinical utility, and
º •
º Development during which extensive testing is performed to demonstrate
that the product meets specified design requirements and that the
design specifications conform to user needs and intended uses.
As with pharmaceutical products, the regulatory requirements for diagnostic
products vary across different countries and geographic regions. In the U.S.,
the FDA classifies diagnostic products into classes (I, II, or III) and the
classification determines the regulatory process for approval. While the
Diagnostics segment has products in all three classes, the vast majority of its
products are categorized as Class I or Class II. Submission of a separate
regulatory filing is not required for Class I products. Class II devices
typically require pre-market notification to the FDA through a regulatory filing
known as a 510(k) submission. Most Class III products are subject to the FDA's
Pre-Marketing Approval (PMA) requirements. Other Class III products, such as
those used to screen blood, require the submission and approval of a BLA.
In the EU, diagnostic products are also categorized into different
categories and the regulatory process, which is governed by the European In
Vitro Diagnostic Medical Device Directive, depends upon the category. Certain
product categories require review and approval by an independent company, known
as a Notified Body, before the manufacturer can affix a CE mark to the product
to show compliance with the Directive. Other products only require a
self-certification process.
In the Vascular segment, the research and development process begins with
research on a specific technology that is evaluated for feasibility and
commercial viability. If the research program passes that hurdle, it moves
forward into development. The development process includes evaluation and
selection of a product design, completion of clinical trials to test the
product's safety and efficacy, and validation of the manufacturing process to
demonstrate its repeatability and ability to consistently meet pre-determined
specifications.
Similar to the diagnostic products discussed above, in the U.S., vascular
products are classified as Class I, II, or III. Most of Abbott's vascular
products are classified as Class II devices that follow the 510(k) regulatory
process or Class III devices that are subject to the PMA process.
In the EU, vascular products are also categorized into different classes and
the regulatory process, which is governed by the European Medical Device
Directive, varies by class. Each product must bear a CE mark to show compliance
with the Directive. Some products require submission of a design dossier to
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the appropriate regulatory authority for review and approval prior to CE marking
of the device. For other products, the company is required to prepare a
technical file which includes testing results and clinical evaluations but can
self-certify its ability to apply the CE mark to the product. Outside the U.S.
and the EU, the regulatory requirements vary across different countries and
regions.
After approval and commercial launch of some vascular products, post-market
trials may be conducted either due to a conditional requirement of the
regulatory market approval or with the objective of proving product superiority.
In the Nutritional segment, the research and development process generally
focuses on identifying and developing ingredients and products that address the
nutritional needs of particular populations (e.g., infants, athletes) or
patients (e.g., people with diabetes). Depending upon the country and/or region,
if claims regarding a product's efficacy will be made, clinical studies
typically must be conducted. Most other product development, such as a product
form change from liquid to powder, generally does not necessitate clinical
studies.
In the U.S., the FDA requires that it be notified of proposed new
formulations and formulation or packaging changes related to infant formula
products. Prior to the launch of an infant formula or product packaging change,
the company is required to obtain the FDA's confirmation that it has no
objections to the proposed product or packaging. For other nutrition products,
notification or pre-approval from the FDA is not required unless the product
includes a new food additive. In some countries, regulatory approval may be
required for certain nutritional products, including infant formula and medical
nutritional products.
Areas of Focus
In 2013 and beyond, Abbott's significant areas of therapeutic focus will
include the following:
Established Pharmaceuticals - Abbott is actively working on plans for about
20 - 30 key brands. Depending on the product, the development activities focus
on new data, markets, formulations, combinations, or indications. Abbott focuses
on building country-specific portfolios made up of global and local
pharmaceutical brands that best meet each local market's needs. Over the next
several years, Established Pharmaceuticals will work to expand the market for
many of its products through registrations across multiple geographies,
including key emerging markets.
Vascular - Ongoing projects in the pipeline include:
º •
º Xience Xpedition, our next-generation drug-eluting stent (DES) with
enhanced deliverability and an expanded size matrix. It utilizes the
Xience PRIME stent, everolimus and biocompatible coating technology
but incorporates new catheter technology for improved deliverability.
Xience Xpedition received U.S. regulatory approval in December 2012
and is also available in Europe and parts of Asia and Latin America.
Abbott expects to launch the product in additional markets in 2013.
º •
º Absorb, the world's first drug eluting bioresorbable vascular scaffold
(BVS) device for the treatment of coronary artery disease that is
gradually resorbed into the vessel wall. In January 2013 Abbott
initiated the ABSORB III clinical trial which is designed to enroll
approximately 2,250 patients of which the majority will be in the U.S.
The data from this trial will be used to support the U.S. regulatory
filing of Absorb. In 2011 Abbott released five-year data from its
ABSORB clinical trial, which showed efficacy and safety results
consistent with the four-year data. In 2011 after receiving CE Mark
approval for Absorb, Abbott initiated a randomized, controlled
clinical trial to further study the device in an expanded population
in Europe. In 2010, Abbott initiated the ABSORB EXTEND clinical trial
which will enroll up to 1,000 patients with more complex coronary
artery disease.
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º •
º MitraClip device for the treatment of mitral regurgitation - Abbott's
MitraClip system which is on the market in Europe and in parts of Asia
and Latin America is currently under review for approval by the FDA.
An amended filing to the FDA was submitted in December 2011. A FDA
panel is expected to review the filing in the first half of 2013.
º •
º Coronary and endovascular core product projects, including new
coronary and endovascular guide wires. The Absolute Pro and Omnilink
Elite stent systems, both for the treatment of iliac artery disease, a
form of peripheral artery disease that affects the lower extremities,
were launched in the U.S. in 2012.
Medical Optics - Abbott is developing a number of new products for patients
undergoing cataract surgery, which are designed to improve physician efficiency
and patient outcomes. Abbott has developed advanced intraocular lenses (IOLs)
that address astigmatism as well as presbyopia. The Tecnis brand monofocal Toric
IOL, which is sold in Europe, is currently undergoing U.S. regulatory review. A
multifocal version of the Toric IOL was launched in a number of international
markets in 2012. A preloaded IOL insertion system that is designed to improve
surgeon efficiency is also currently under regulatory review in the U.S.; the
product was launched in Europe in 2012. Abbott is continuing the development
activities required to obtain U.S. approval for an enhanced version of the
Synchrony IOL which is designed to mimic the eye's natural ability to change
focus and deliver improved vision at all distances; this product was launched in
Europe in late 2012. Abbott has also developed a new diagnostic instrument and
laser treatment planning software which is designed to improve visual outcomes.
After the receipt of CE Mark approval in November 2011, this instrument and
software were launched in Europe in 2012. A PMA filing for U.S. regulatory
approval of this product was submitted in 2012.
Molecular Diagnostics - Various new molecular in vitro diagnostic (IVD)
products, including oncology and infectious disease assays and a next generation
instrument system are in various stages of development and commercialization.
Abbott's companion diagnostic test for an ALK gene rearrangement test for
non-small-cell lung cancer has been approved in more than 40 countries around
the world. In 2012, companion diagnostic efforts were expanded to include
collaborative efforts with multiple major pharmaceutical companies. In the U.S.,
an assay to genotype HCV-infected patients to aid in the choice of an
appropriate therapy was submitted for regulatory approval. Additional assays for
infectious diseases including MTb and MTb drug resistance are in development.
Core Laboratory Diagnostics - Abbott is working on the development of assays in
various areas including infectious disease, cardiac care, fertility and
metabolics, and on next-generation blood screening, hematology, and
immunochemistry instrument systems. Abbott is also focusing on near-term
launches of automation solutions, such as its next-generation track system,
ACCELERATOR a3600 to increase efficiency in laboratories.
Diabetes Care - In the first quarter of 2012, Abbott obtained U.S. regulatory
approval for its FreeStyle InsuLinx blood glucose monitoring system that
includes a touch-screen interface and other features designed to support the
insulin-using patient. After receiving CE Mark for this system in May 2011 and
Health Canada approval in October 2011, Abbott is continuing to provide R&D
support as the product is launched in additional markets. Development is also
continuing on an updated hospital blood glucose monitoring system for which a
filing for approval is projected to be submitted in the U.S. during the first
half of 2013. Abbott is also developing a next-generation monitoring system
under the Precision product platform and for which Abbott anticipates submitting
filings for approval in various markets in the second half of 2013.
Nutrition - Abbott is focusing its research and development spend on six benefit
platforms that span the pediatric, adult and performance nutrition areas:
immunity, cognition, lean body mass, inflammation, metabolism and tolerance.
Numerous new products that build on advances in these benefit platforms are
currently under development and are expected to be launched over the coming
years.
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Given the diversity of Abbott's business, its intention to remain a
broad-based healthcare company and the numerous sources for potential future
growth, no individual project is expected to be material to cash flows or
results of operations over the next five years. Factors considered included
research and development expenses projected to be incurred for the project over
the next year relative to Abbott's total research and development expenses as
well as qualitative factors, such as marketplace perceptions and impact of a new
product on Abbott's overall market position. There were no delays in Abbott's
2012 research and development activities that are expected to have a material
impact on operations.
While the aggregate cost to complete the numerous projects currently in
development is expected to be material, the total cost to complete will depend
upon Abbott's ability to successfully complete each project, the rate at which
each project advances, and the ultimate timing for completion. Given the
potential for significant delays and the high rate of failure inherent in the
research and development of new pharmaceutical and medical device products and
technologies, it is not possible to accurately estimate the total cost to
complete all projects currently in development. After the separation of AbbVie,
Abbott plans to manage its portfolio of projects to achieve research and
development spend equal to approximately 6 percent to 7 percent of sales each
year. Abbott does not regularly accumulate or make management decisions based on
the total expenses incurred for a particular development phase in a given
period.
Business Combinations, Technology Acquisitions and Related Transactions
On September 8, 2010, Abbott acquired Piramal Healthcare Limited's
Healthcare Solutions business, a leader in the Indian branded generics market,
for $2.2 billion, in cash, plus additional payments of $400 million annually in
2011, 2012, 2013 and 2014. Abbott recorded a $1.6 billion liability for the
present value of the additional payments at the acquisition date. The
acquisition was financed with cash. The allocation of the fair value of the
acquisition resulted in the recording of $2.7 billion of deductible acquired
intangible assets and $1.0 billion of deductible goodwill. Acquired intangible
assets consist primarily of trade names, customer relationships and associated
rights and are amortized over an average of 19 years.
In February 2010, Abbott acquired Solvay's pharmaceuticals business (Solvay
Pharmaceuticals) for approximately $6.1 billion, in cash, plus additional
payments of up to EUR 100 million per year if certain sales milestones are met
in 2011, 2012 and 2013. Contingent consideration of approximately $290 million
was recorded. The acquisition of Solvay Pharmaceuticals provided Abbott with a
large and complementary portfolio of pharmaceutical products and expands
Abbott's presence in key global emerging markets. Abbott acquired control of
this business on February 15, 2010 and the financial results of the acquired
operations are included in these financial statements beginning on that date.
Net sales for the acquired operations for 2010 were approximately $3.1 billion.
Pretax loss of the acquired operations, including acquisition, integration and
restructuring expenses, for 2010 was approximately $395 million. The acquisition
was funded with cash and short-term investments. The allocation of the fair
value of the acquisition resulted in the recording of $2.2 billion of
non-deductible goodwill, $4.1 billion of non-deductible intangible assets,
$500 million of non-deductible acquired in-process research and development
assets, net tangible assets of $700 million and deferred income taxes of
$1.1 billion. Acquired intangible assets consist primarily of product rights for
currently marketed products and are amortized over 2 to 14 years (average of
11 years). Acquired in-process research and development projects are accounted
for as indefinite lived intangible assets until regulatory approval or
discontinuation. The net tangible assets acquired consist primarily of trade
accounts receivable of approximately $675 million, inventory of approximately
$390 million, property and equipment of approximately $725 million, net of
assumed liabilities, primarily trade accounts payable, accrued compensation and
other liabilities.
Had the acquisition of Solvay Pharmaceuticals taken place on January 1,
2010, unaudited pro forma net sales, net earnings and diluted earnings per share
for 2010 would have been $35.8 billion, $4.6 billion and $2.96, respectively.
The pro forma information includes adjustments for amortization of intangible
assets and fair value adjustments to acquisition-date inventory as well as
acquisition, integration and restructuring expenses. The pro forma financial
information is not necessarily indicative of the results of operations as they
would have been had the transaction been effected on the assumed date.
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In March 2010, Abbott acquired STARLIMS Technologies for approximately
$100 million, in cash, net of cash held by STARLIMS, providing Abbott with
leading products and expertise to build its position in laboratory informatics.
A substantial portion of the fair value of the acquisition has been allocated to
goodwill and amortizable intangible assets. In April 2010, Abbott acquired the
outstanding shares of Facet Biotech Corporation for approximately $430 million,
in cash, net of cash held by Facet. The acquisition enhanced Abbott's early- and
mid-stage pharmaceutical pipeline, including a biologic for multiple sclerosis
and compounds that complement Abbott's oncology program. A substantial portion
of the fair value of the acquisition was allocated to acquired in-process
research and development that is accounted for as an indefinite-lived intangible
asset until regulatory approval or discontinuation.
Except for the acquisition of Solvay Pharmaceuticals, had the above
acquisitions taken place on January 1 of the previous year, consolidated net
sales and income would not have been significantly different from reported
amounts.
Abbott's Proprietary Pharmaceutical Products segment has entered into
various collaboration research and development agreements. In 2012, Abbott
acquired AP214, a drug under development for the prevention of acute kidney
injury associated with major cardiac surgery in patients at increased risk, and
as a result of this transaction, Abbott recorded a charge to acquired in-process
and collaborations research and development of $110 million. In addition, in
2012, Abbott entered into a global collaboration to develop and commercialize an
oral, next-generation JAK1 inhibitor in Phase II development with the potential
to treat multiple autoimmune diseases, and as a result of this transaction
Abbott recorded a charge to acquired in-process and collaborations research and
development of $150 million. Additional payments of approximately $1.2 billion
could be required for the achievement of certain development, regulatory and
commercial milestones under this agreement. Under another collaboration, Abbott
was granted the rights in 2012 to utilize up to three antibody-drug conjugate
compounds and Abbott recorded a charge to acquired in-process and collaborations
research and development of $28 million. Additional payments of approximately
$220 million for each licensed compound could be required for the achievement of
certain development, regulatory and commercial milestones under this agreement.
In connection with the acquisition of Solvay Pharmaceuticals, the achievement of
a certain sales milestone resulted in a payment of approximately $134 million in
the first quarter of 2012 for which a liability was previously established.
During 2010 and 2011, Abbott entered into a series of transactions with
Reata Pharmaceuticals which included (1) a collaboration agreement for the joint
development and commercialization of second generation oral antioxidant
inflammation modulators resulting in a charge to acquired in-process and
collaborations research and development of $400 million in 2011, (2) an
agreement to acquire licensing rights outside the U.S., excluding certain Asian
markets, to bardoxolone methyl, a product in development for the treatment of
chronic kidney disease resulting in a charge to acquired in-process and
collaborations research and development of $238 million in 2010 and (3) the
acquisition of equity interests in Reata of $62 million each in 2011 and 2010.
In 2011, certain milestones were achieved in the development for the treatment
of chronic kidney disease and charges to acquired in-process and collaborations
research and development of $188 million were recorded. In the first quarter of
2012, $50 million of research and development expense was recorded related to
the achievement of a clinical development milestone under the license agreement.
The license agreement requires additional payments of up to $150 million if
certain development and regulatory milestones associated with the chronic kidney
disease compound are achieved.
On October 17, 2012 Reata informed Abbott that it is discontinuing the
Phase III clinical study for bardoxolone methyl for chronic kidney disease.
Reata and Abbott will closely examine the data from this study to determine
whether there is an appropriate path forward for the development of bardoxolone
methyl in chronic kidney disease or other indications. In the fourth quarter of
2012, Abbott recorded a charge of approximately $50 million for the impairment
of the equity investment in Reata.
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In 2011, Abbott entered into an agreement with Biotest AG to develop and
commercialize a treatment for rheumatoid arthritis and psoriasis resulting in a
charge to acquired in-process and collaborations research and development of
$85 million. Additional payments totaling up to $395 million based on projected
regulatory approval timelines could be required for the achievement of certain
development, regulatory and commercial milestones under this agreement. In 2010,
Abbott entered into an agreement with Neurocrine Biosciences to develop and
commercialize a product for the treatment of endometriosis resulting in a charge
to acquired in-process and collaborations research and development of
$75 million. Additional payments of approximately $500 million could be required
for the achievement of certain development, regulatory and commercial milestones
under this agreement.
Goodwill
At December 31, 2012, goodwill recorded as a result of business combinations
totaled $15.8 billion. Goodwill is reviewed for impairment annually or when an
event that could result in an impairment occurs. The results of the last
impairment test indicated that the fair value of each reporting unit was
substantially in excess of its carrying value except for the Medical Optics
unit. While the fair value of the Medical Optics business exceeds its carrying
value, extended economic pressure on government-reimbursed cataract procedures
in Europe and on the global LASIK surgery business as well as longer regulatory
approval timelines for products currently under development could result in a
valuation in the future where the fair value of the Medical Optics unit has
declined below its carrying value, thereby triggering the requirement to
estimate the implied fair value of the goodwill and measure for impairment.
Financial Condition
Cash Flow
Net cash from operating activities amounted to $9.3 billion, $9.0 billion
and $8.7 billion in 2012, 2011 and 2010, respectively. Trade accounts payable
and other liabilities in Net cash from operating activities in 2012 includes the
payment of approximately $1.5 billion related to a litigation accrual recorded
in 2011. This was partially offset by increases in other liabilities, primarily
restructuring reserves. Income taxes payable in 2012 and 2011 includes
$408 million and $580 million, respectively, of tax benefits related to the
favorable resolution of various tax positions pertaining to prior years. While
substantially all cash and cash equivalents at December 31, 2012 that will be
retained by Abbott after the separation and all cash and cash equivalents at
December 31, 2011 and 2010 is considered reinvested indefinitely in foreign
subsidiaries, Abbott does not expect such reinvestment to affect its liquidity
and capital resources. If these funds were needed for operations in the U.S.,
Abbott would be required to accrue and pay U.S. income taxes to repatriate these
funds. Abbott believes that it has sufficient sources of liquidity to support
its assumption that the disclosed amount of undistributed earnings at
December 31, 2012 can be considered to be reinvested indefinitely. Abbott funded
$379 million in 2012, $394 million in 2011 and $525 million in 2010 to defined
pension plans. Abbott expects pension funding for its main domestic pension plan
of $170 million in 2013; the decrease primarily reflects the separation of
AbbVie and the transfer of certain plan assets and liabilities to AbbVie. Abbott
expects annual cash flow from operating activities to continue to exceed
Abbott's capital expenditures and cash dividends.
For 2010, the reductions in cash and cash equivalents due to the effect of
exchange rate changes was primarily driven by the impact of changes in the value
of the U.S. dollar compared to the euro on non-dollar denominated cash and cash
equivalents. While future fluctuations in the value of the U.S. dollar against
foreign currencies could have a substantial effect on the dollar value of
Abbott's cash and cash equivalents, such fluctuations are not expected to
materially impact Abbott's liquidity.
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Debt and Capital
At December 31, 2012, Abbott's long-term debt rating was A+ by Standard &
Poor's Corporation and A1 by Moody's Investors Service. In 2012, Abbott replaced
unused lines of credit of $3.0 billion and $3.7 billion that were to expire in
October 2012 and in 2013, respectively, with two five-year credit facilities
totaling $7.0 billion that support commercial paper borrowing arrangements. One
of the credit facilities totaling $2.0 billion will support AbbVie commercial
paper borrowings after separation and expired for Abbott at the separation of
AbbVie from Abbott on January 1, 2013.
In 2012, Abbott redeemed $7.7 billion of long-term notes in preparation for
the separation of AbbVie from Abbott and repaid $1 billion of long-term notes
that were due in 2012. In addition, AbbVie Inc., a wholly owned subsidiary of
Abbott, issued $14.7 billion of long-term notes that were guaranteed by Abbott
until AbbVie's separation from Abbott on January 1, 2013. In 2011, Abbott repaid
$2.0 billion of long-term notes using primarily short-term borrowings. Under a
registration statement filed with the Securities and Exchange Commission in
February 2009, Abbott issued $3.0 billion of long-term debt in the second
quarter of 2010 with maturity dates in 2015, 2020 and 2040 and interest rates of
2.7 percent, 4.125 percent and 5.3 percent, respectively. The debt due in 2015
was extinguished in 2012. Proceeds from this debt were used to pay down
short-term borrowings.
In October 2008, the board of directors authorized the purchase of up to
$5 billion of Abbott's common shares from time to time. Under this
authorization, 37.0 million and 14.8 million shares were purchased in 2012 and
2010 at a cost of approximately $2.2 billion and $800 million, respectively. No
shares were purchased under this authorization in 2011. Abbott plans to purchase
shares from time to time in 2013.
The judgment entered in 2009 by the U.S. District Court for the Eastern
District of Texas against Abbott in its litigation with New York University and
Centocor, Inc. required Abbott to secure the judgment in the event that its
appeal to the Federal Circuit court was unsuccessful in overturning the district
court's decision. In the first quarter of 2010, Abbott deposited $1.87 billion
with an escrow agent and considered these assets to be restricted. On
February 23, 2011, the Federal Circuit reversed the district court's final
judgment and found Centocor's patent invalid. On April 25, 2011, Centocor
petitioned the Federal Circuit to rehear and reconsider the decision. In June
2011 the Federal Circuit denied Centocor's petition and the restrictions on the
funds were lifted.
Working Capital
Working capital was $18.0 billion at December 31, 2012, $8.3 billion at
December 31, 2011 and $5.1 billion at December 31, 2010. The increase in working
capital in 2012 was due primarily to higher cash generated from operating
activities and higher cash and investments as a result of the net issuance of
long-term debt in connection with the separation of AbbVie from Abbott. The
increase in working capital in 2011 was due primarily to higher cash generated
from operating activities and lower debt levels. The decrease in working capital
in 2010 was due primarily to cash and investments used to acquire Solvay's
pharmaceuticals business and Piramal Healthcare Limited's Healthcare Solutions
business.
Substantially all of Abbott's trade receivables in Italy, Spain, Portugal,
and Greece are with governmental health systems. Given the economic conditions
and sovereign debt issues in these countries, the time it takes to collect
outstanding receivables increased in 2011. In 2012, collection times improved
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relative to 2011 with the exception of Greece. Outstanding net governmental
receivables in these countries at December 31, 2012 were: (dollars in millions)
Net Percentage Over
Receivables One Year Past Due
Italy $ 564 16.2
Spain 431 0.8
Portugal 121 28.4
Greece 88 29.6
With the exception of Greece, Abbott historically has collected almost all
of the outstanding receivables in these countries. Abbott continues to monitor
the credit worthiness of customers located in these and other geographic areas
and establishes an allowance against a trade receivable when it is probable that
the balance will not be collected. In addition to closely monitoring economic
conditions and budgetary and other fiscal developments in these countries,
Abbott regularly communicates with its customers regarding the status of
receivable balances, including their payment plans and obtains positive
confirmation of the validity of the receivables. Abbott also monitors the
potential for and periodically has utilized factoring arrangements to mitigate
credit risk although the receivables included in such arrangements have
historically not been a material amount of total outstanding receivables. If
government funding were to become unavailable in these countries or if
significant adverse changes in their reimbursement practices were to occur,
Abbott may not be able to collect the entire balance.
Capital Expenditures
Capital expenditures of $1.8 billion in 2012, $1.5 billion in 2011 and
$1.0 billion in 2010 were principally for upgrading and expanding manufacturing,
research and development, and administrative support facilities in all segments,
investments in information technology, and laboratory instruments placed with
customers.
Contractual Obligations
The table below summarizes Abbott's estimated contractual obligations as of
December 31, 2012. The amounts do not reflect the separation of AbbVie from
Abbott on January 1, 2013. After the separation of AbbVie from Abbott on
January 1, 2013, principal payments required on long-term debt outstanding and
retained by Abbott are $309 million in 2013 and $3.3 billion in 2019 and
thereafter. Payments on long-term debt to be made by AbbVie, including interest,
total approximately $19.6 billion.
Payment Due By Period
2018 and
Total 2013 2014-2015 2016-2017 Thereafter
(dollars in millions)
Long-term debt, including
current maturities and future
interest payments $ 26,403 $ 839 $ 5,039 $ 4,929 $ 15,596
Operating lease obligations 795 146 234 170 245
Capitalized auto lease
obligations 92 31 61 - -
Purchase commitments (a) 3,154 3,048 88 1 17
Other long-term liabilities
reflected on the consolidated
balance sheet -
Benefit plan obligations 5,126 - 1,024 1,149 2,953
Other 3,869 - 3,682 32 155
Total (b) $ 39,439 $ 4,064 $ 10,128 $ 6,281 $ 18,966
º (a)
º Purchase commitments are for purchases made in the normal course of
business to meet operational and capital expenditure requirements.
º (b)
º Unrecognized tax benefits totaling $2.0 billion are excluded from the table
above as Abbott is unable to reasonably estimate the period of cash
settlement with the respective taxing authorities on such items.
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Contingent Obligations
Abbott has periodically entered into agreements in the ordinary course of
business, such as assignment of product rights, with other companies which has
resulted in Abbott becoming secondarily liable for obligations that Abbott was
previously primarily liable. Since Abbott no longer maintains a business
relationship with the other parties, Abbott is unable to develop an estimate of
the maximum potential amount of future payments, if any, under these
obligations. Based upon past experience, the likelihood of payments under these
agreements is remote. In addition, Abbott periodically acquires a business or
product rights in which Abbott agrees to pay contingent consideration based on
attaining certain thresholds or based on the occurrence of certain events.
Legislative Issues
In 2010, the Patient Protection and Affordable Care Act and the Health Care
and Education Reconciliation Act (collectively referred to herein as "health
care reform legislation") were signed into law in the U.S. Health care reform
legislation included an increase in the basic Medicaid rebate rate from
15.1 percent to 23.1 percent and extended the rebate to drugs provided through
Medicaid managed care organizations.
Beginning in 2013, health care reform legislation will eliminate the federal
income tax deduction for prescription drug expenses of retirees for which Abbott
receives reimbursement under the Medicare Part D retiree drug subsidy program.
As a result, Abbott recorded a charge of approximately $60 million in the first
quarter 2010 to reduce deferred tax assets associated with retiree health care
liabilities.
In 2011, Abbott began recording the annual fee imposed by health care reform
legislation on companies that sell branded prescription drugs to specified
government programs. The amount of the annual fee is based on the ratio of
certain of Abbott's sales as compared to the total such sales of all covered
entities multiplied by a fixed dollar amount specified in the legislation by
year. In 2011, additional rebates were incurred related to the Medicare Part D
coverage gap "donut hole." Beginning in 2013, Abbott will record the 2.3 percent
excise tax imposed by health care reform legislation on the sale of certain
medical devices in the U.S.
Abbott's primary markets are highly competitive and subject to substantial
government regulations throughout the world. Abbott expects debate to continue
over the availability, method of delivery, and payment for health care products
and services. It is not possible to predict the extent to which Abbott or the
health care industry in general might be adversely affected by these factors in
the future. A more complete discussion of these factors is contained in Item 1,
Business, and Item 1A, Risk Factors, to the Annual Report on Form 10-K.
Private Securities Litigation Reform Act of 1995 - A Caution Concerning
Forward-Looking Statements
Under the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, Abbott cautions investors that any forward-looking statements or
projections made by Abbott, including those made in this document, are subject
to risks and uncertainties that may cause actual results to differ materially
from those projected. Economic, competitive, governmental, technological and
other factors that may affect Abbott's operations are discussed in Item 1A, Risk
Factors, to the Annual Report on Form 10-K.
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