Abbott Laboratories : Abbott Reports Double-Digit Ongoing Earnings-Per-Share Growth in First Quarter; Raises Full-Year 2012 Outlook
04/19/2012| 06:16am US/Eastern
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Abbott Park, Illinois (NYSE:
ABT) - Abbott today announced financial results for the
first quarter ended March 31, 2012.
Diluted earnings per share, excluding specified items,
were $1.03, reflecting 13.2 percent growth and
exceeding Abbott's previous guidance range. Diluted
earnings per share under Generally Accepted Accounting
Principles (GAAP) were $0.78, including specified items,
reflecting 41.8 percent growth.
Excluding foreign exchange, worldwide sales increased
nearly 6 percent. Reported sales increased
4.6 percent, including an unfavorable 1.3 percent
effect of foreign exchange.
Abbott is raising its ongoing earnings-per-share guidance
for 2012 to $5.00 to $5.10 from $4.95 to $5.05,
reflecting another year of expected strong performance.
First-quarter results included an adjusted gross margin
ratio of 61.1 percent, an increase of 260 basis
points over 2011, driven by improved efficiencies across
a number of operating divisions and favorable product
mix.
The adjusted operating margin increased 150 basis points
over 2011, driven by improvement in the combined
diversified medical products businesses as well as the
research-based pharmaceutical business.
"Abbott is off to a strong start in 2012, delivering
double-digit ongoing earnings-per-share growth," said
Miles D. White, chairman and chief executive officer,
Abbott. "As a result, we're raising our outlook
for the full year. During the quarter, we also announced a
number of new product launches and strategic partnerships
to enhance the pipelines of each of our major businesses.
And, we remain focused on the process of separating Abbott
into two leading health care companies, which remains on
track to be completed by the end of the year.
The following is a summary of first-quarter 2012 sales by
major business category.
% Change vs. 1Q11
Sales ($ in millions)
Int'l
Total
U.S.
Int'l
Total
U.S.
Operational
Reported
Operational
Reported
Total Sales
3,722
5,735
9,457
5.8
5.9
3.8
5.9
4.6
Proprietary
Pharmaceuticals
2,053
2,019
4,072
6.6
10.2
7.7
8.3
7.1
Nutritionals
707
859
1,566
11.0
9.9
9.3
10.4
10.1
Established
Pharmaceuticals
…
1,257
1,257
n/a
1.9
(1.6)
1.9
(1.6)
Core Laboratory
Diagnostics
174
679
853
12.8
4.9
3.1
6.4
4.9
Molecular
Diagnostics
47
58
105
3.1
11.4
8.4
7.6
6.0
Point of Care
Diagnostics
64
20
84
16.7
28.4
28.2
19.3
19.3
Vasculara
342
461
803
(12.2)a
2.2
1.3
(4.4)
(4.9)a
Diabetes Care
139
179
318
7.3
(7.0)
(8.7)
(1.4)
(2.4)
Medical Optics
100
172
272
1.6
2.2
1.5
1.9
1.5
Other Salesb
96
31
127
17.7
(17.8)
(18.8)
6.8
6.5
The following is a summary of first-quarter 2012 sales for
select products.
% Change vs. 1Q11
Sales ($ in millions)
Int'l
Total
U.S.
Int'l
Total
U.S.
Operational
Reported
Operational
Reported
HUMIRA
773
1,161
1,934
22.7
17.4
14.2
19.4
17.4
TRILIPIX/TriCor
(fenofibrate)
254
75
329
(12.1)
(1.8)
(5.3)
(10.0)
(10.7)
AndroGel
232
9
241
23.5
28.9
26.2
23.7
23.6
Kaletra
55
166
221
(15.0)
(6.8)
(9.8)
(8.9)
(11.1)
Lupron
141
58
199
18.1
(8.6)
(10.5)
8.7
8.0
Niaspan
191
…
191
(15.4)
n/a
n/a
(15.4)
(15.4)
Synthroid
129
26
155
10.5
7.1
2.4
9.9
9.1
Creon
68
78
146
5.6
17.6
14.0
11.9
10.0
Pediatric Nutritionals
357
503
860
15.4
13.0
12.8
13.9
13.8
Adult Nutritionals
347
356
703
7.3
6.0
4.8
6.6
6.0
Xience Drug-Eluting
Stents
149
255
404
19.3
0.7
0.5
6.9
6.7
Other Coronary
Productsc
52
103
155
2.2
5.1
3.7
4.1
3.2
Endovasculard
62
52
114
5.2
5.9
4.0
5.6
4.7
Note:
1)
See "Consolidated Statement of Earnings" for
more information.
2)
"Operational" growth reflects percentage
change over the prior year excluding the impact of
exchange rates.
a
Excluding the expected decline of certain royalty and
supply arrangement revenues (including Promus), U.S.
Vascular sales increased 7.9 percent and worldwide
reported Vascular sales increased 3.8 percent.
b
Includes sales primarily from Contract Pharmaceutical
Manufacturing and Animal Health.
c
Includes guide wires, balloon catheters and other
coronary products.
d
Includes vessel closure, carotid stents and other
peripheral products.
n/a = Not applicable
Business Highlights
Released Strong Phase 2 Results from Abbott's Advancing
Hepatitis C Program
Released clinical trial results from two interferon-free,
Phase 2 studies for the treatment of hepatitis C,
PILOT and CO-PILOT. Additional data from the studies will
be presented later this week at the annual meeting of the
European Association for the Study of the Liver (EASL).
Announced Collaboration for Novel Oral Therapy to Treat
Autoimmune Diseases
Announced a global collaboration with Galapagos to develop
and commercialize an oral, next-generation JAK1 inhibitor
in Phase 2 development with the potential to treat
rheumatoid arthritis and other autoimmune diseases.
Received FDA Approval for Absolute Pro Vascular
Self-Expanding Stent for Iliac Artery Disease
Announced U.S. Food and Drug Administration (FDA) approval
of the Absolute Pro® Vascular Self-Expanding Stent System
for the treatment of iliac artery disease, a form of
peripheral artery disease that affects the lower
extremities.
Received European Approval for HUMIRA in Ulcerative
Colitis
Received approval from the European Committee for Medicinal
Products for Human Use (CHMP) for HUMIRA® in adults with
moderate to severely active ulcerative colitis (UC). HUMIRA
is the first and only self-injectable biologic therapy
available for UC patients in Europe.
Received CE Mark for PLEX-ID Molecular System and Tests
Received CE Mark in Europe for Abbott's rapid,
high-throughput PLEX-ID™ instrument, along with three
assays for use on the system. PLEX-ID addresses a
significant unmet need for rapid detection and
identification of a broad-range of infection-causing
microbes.
Announced New Nutrition Manufacturing Facility in the
United States
Announced plans to build a nutrition manufacturing facility
in Tipp City, Ohio, to produce three of the company's
fastest-growing adult brands, PediSure®, Ensure® and
Glucerna®, for the North American market. The plant is
expected to be operational in late 2013.
Received FDA Clearance for New FreeStyle InsuLinx Blood
Glucose Monitoring System
Announced FDA clearance for the FreeStyle InsuLinx Blood
Glucose Monitoring System, the first from Abbott to include
a touch-screen interface, automated logbook and several
personalization features designed to improve the diabetes
management experience for patients.
Announced Patient Enrollment in Two Phase 3 Studies of
HUMIRA for HS
Initiated two Phase 3 clinical trials designed to evaluate
the safety and efficacy of an investigational use of HUMIRA
in adult patients with moderate to severe hidradenitis
suppurativa (HS), a condition for which there are currently
no approved treatments.
Presented Data on Key Vascular Devices at ACC 2012
Presented new data on Abbott's leading Vascular
pipeline, including study results in patients at high
surgical risk treated with the investigational MitraClip®
system, and two-year clinical results on the
investigational Absorb™ bioresorbable vascular scaffold.
Announced Results from Phase 3 Clinical Trial Evaluating
LCIG
Announced positive results from a Phase 3 trial evaluating
Abbott's investigational treatment for advanced
Parkinson's disease, levodopa-carbidopa intestinal gel
(LCIG), which showed significant improvements over
levodopa-carbidopa immediate release tablets.
Abbott raises ongoing earnings-per-share outlook for
2012
Abbott is raising its ongoing earnings-per-share guidance
for the full-year 2012 to $5.00 to $5.10 from $4.95 to
$5.05, reflecting another year of expected strong
performance.
Abbott forecasts specified items for the full-year 2012 of
approximately $0.52 per share, primarily associated with
in-process R&D, acquisition integration and cost-reduction
initiatives. Including these specified items, projected
earnings per share under Generally Accepted Accounting
Principles (GAAP) would be $4.48 to $4.58 for the full-year
2012. This forecast of specified items excludes additional
future one-time separation and bond refinancing costs
related to the planned separation of Abbott into two
companies, which will be quantified at a later date.
Abbott declares 353rd quarterly dividend
On Feb. 17, 2012, the board of directors of Abbott declared
the company's quarterly common dividend of 51 cents per
share. The cash dividend is payable May 15, 2012, to
shareholders of record at the close of business on April
13, 2012. This marks the 353rd consecutive dividend paid by
Abbott since 1924. Abbott is a member of the S&P 500
Dividend Aristocrats Index, which tracks companies that
have annually increased their dividends for 25 consecutive
years.
About Abbott
Abbott (NYSE:
ABT) is a global, broad-based health care company
devoted to the discovery, development, manufacture and
marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics. The
company employs approximately 91,000 people and markets its
products in more than 130 countries.
Abbott will webcast its live first-quarter earnings
conference call through its Investor Relations Web site at
www.abbottinvestor.com
at 8 a.m. Central time today. An archived edition of the
call will be available after 11 a.m. Central time.
Private Securities Litigation Reform Act of 1995 - A
Caution Concerning Forward-Looking Statements
Some statements in this news release may be forward-looking
statements for purposes of the Private Securities
Litigation Reform Act of 1995, including the planned
separation of the research-based pharmaceutical company
from the diversified medical products company and the
expected financial results of the two companies after the
separation. Abbott cautions that these forward-looking
statements are subject to risks and uncertainties that may
cause actual results to differ materially from those
indicated in the forward-looking statements. Economic,
competitive, governmental, technological and other factors
that may affect Abbott's operations are discussed in
Item 1A, "Risk Factors," to our Annual
Report on Securities and Exchange Commission Form 10-K
for the year ended Dec. 31, 2011, and are incorporated
by reference. Abbott undertakes no obligation to release
publicly any revisions to forward-looking statements as a
result of subsequent events or developments.
Abbott Laboratories and Subsidiaries
Consolidated Statement of Earnings
First Quarter Ended March 31, 2012 and 2011
(in millions, except per share data)
(unaudited)
2012
2011
% Change
Net Sales
$9,457
$9,041
4.6
Cost of products sold
3,725
3,859
(3.5)
Research and development
1,006
930
8.1
Acquired in-process and collaborations research and
development
150
100
n/m
Selling, general and administrative
3,000
2,851
5.3
Total Operating Cost and Expenses
7,881
7,740
1.8
Operating earnings
1,576
1,301
21.1
Net interest expense
109
124
(11.7)
Net foreign exchange (gain) loss
25
(33)
n/m
Other (income) expense, net
(71)
141
n/m
Earnings before taxes
1,513
1,069
41.6
Taxes on earnings
271
205
32.2
Net Earnings
$1,242
$864
43.8
Net Earnings Excluding Specified Items,
as described below 1)
$1,648
$ 1,419
16.2
Diluted Earnings per Common Share
$0.78
$0.55
41.8
Diluted Earnings Per Common Share, Excluding Specified
Items,
as described below 1)
$1.03
$0.91
13.2
Average Number of Common Shares Outstanding Plus
Dilutive
Common Stock Options and Awards
1,590
1,559
1)
2012 Net Earnings Excluding Specified Items excludes
after-tax charges of $150 million, or $0.09
per share, for acquired in-process research and
development related to the Galapagos collaboration,
$50 million, or $0.03 per share, for a
milestone payment related to the Reata collaboration,
$107 million, or $0.07 per share, for
litigation reserves, $34 million, or
$0.02 per share, for separation costs, and
$65 million, or $0.04 per share, for restructuring
and integration charges.
2011 Net Earnings Excluding Specified Items excludes
after-tax charges of $81 million, or
$0.05 per share, associated with the
acquisition of Solvay Pharmaceuticals,
$103 million, or $0.07 per share, for
restructuring in the pharmaceutical business,
$58 million, or $0.04 per share, for
other cost reduction initiatives and other,
$137 million, or $0.09 per share, for
the 2009 and 2010 impact of the change to a calendar
year end for international operations,
$100 million, or $0.06 per share,
relating to acquired in-process research and
development related to the Reata collaboration, and
$76 million, or $0.05 per share, for litigation
reserves.
NOTE: See attached questions and answers section for
further explanation of Consolidated Statement of
Earnings line items.
n/m = Percent change is not meaningful.
Questions & Answers
Q1)
What drove sales growth in the quarter?
A1)
Excluding foreign exchange, worldwide sales increased
nearly 6 percent. Reported sales increased
4.6 percent, including an unfavorable
1.3 percent effect of foreign exchange. In
emerging markets, sales increased more than
10 percent, excluding the negative impact of
foreign exchange, with strong double-digit growth in
the key emerging markets across the businesses.
Worldwide Nutritionals sales increased
10.4 percent in the quarter, excluding an
unfavorable 0.3 percent effect of foreign
exchange. U.S. Nutritionals increased
11.0 percent, with U.S. Pediatric Nutritionals
sales growth of 15.4 percent on continued share
gains of our infant formula, Similac®, and continued
double-digit growth of PediaSure. U.S. Adult
Nutritionals grew 7.3 percent, driven by
double-digit growth of Ensure and Glucerna. In April,
we initiated construction of a new manufacturing
facility in Ohio to support the growth of these brands.
International Nutritionals increased 9.9 percent,
excluding an unfavorable 0.6 percent effect of
foreign exchange, driven by continued strong growth of
Pediatric Nutritionals in emerging markets.
Global sales of Core Laboratory Diagnostics increased
6.4 percent, excluding an unfavorable
1.5 percent effect of foreign exchange, driven by
12.8 percent growth in the U.S. due to continued
uptake of PRISM, and 4.9 percent international
growth, excluding an unfavorable 1.8 percent
effect of foreign exchange. Molecular Diagnostics and
Point of Care Diagnostics also drove global Diagnostics
sales growth in the quarter.
Worldwide Vascular sales increased nearly
4 percent, excluding certain royalty and supply
arrangement revenues, with strong growth of our XIENCE
drug-eluting stent. Endovascular and Other Coronary
Products also contributed to Vascular growth. Abbott
received approval for XIENCE PRIME™ in Japan in April,
which we expect to drive continued share gains over the
course of the year. On a reported basis, including the
expected reduction in certain royalty and supply
arrangement revenues (including Promus), worldwide
Vascular sales declined 4.9 percent.
Worldwide Proprietary Pharmaceuticals sales increased
8.3 percent, excluding an unfavorable
1.2 percent effect of foreign exchange, driven by
strong growth across a number of key franchises
including HUMIRA, AndroGel®, Creon®, Lupron® and
Synthroid®.
Q2)
What is the update on Abbott's planned separation
into two leading health care companies?
A2)
In October 2011, Abbott announced plans to separate
into two publicly traded companies, one in diversified
medical products and the other in research-based
pharmaceuticals. The diversified medical products
company will consist of Abbott's branded generic
pharmaceuticals, devices, diagnostics and nutritionals
businesses, and will retain the Abbott name. In March
2012, the research-based pharmaceutical company, which
will include Abbott's current portfolio of
proprietary pharmaceuticals and biologics, was named
AbbVie.
The transaction is intended to take the form of a
tax-free distribution to Abbott shareholders of a new
publicly traded stock for the new pharmaceutical
company. The expected stock distribution ratio will be
determined at a future date. It is expected that the
two companies will each pay a dividend that, when
combined, will equal the current Abbott dividend at the
time of separation.
We continue to expect the separation to be completed by
the end of this year.
Q3)
What was the gross margin ratio in the quarter?
A3)
The gross margin ratio before and after specified items
is shown below (dollars in millions):
1Q12
Cost of
Products
Sold
Gross
Margin
Gross
Margin %
As reported (GAAP)
$3,725
$5,732
60.6%
Adjusted for specified
items:Restructuring/integration/other
($46)
$46
0.5%
As adjusted
$3,679
$5,778
61.1%
The adjusted gross margin ratio was 61.1 percent in the
first quarter, an increase of 260 basis points from the prior
year quarter, driven by improved efficiencies across a number
of operating divisions and favorable product mix.
Q4)
What drove ongoing SG&A and R&D investment?
A4)
Both ongoing SG&A and R&D investment reflect
Abbott's continued investment in programs to drive
future growth. Ongoing R&D expense as a percentage
of sales was 10.0 percent, reflecting continued
investment in Abbott's pipeline, including programs
in vascular devices, diagnostics, nutritionals,
immunology, neuroscience, oncology and HCV.
Q5)
What was the tax rate?
A5)
The ongoing tax rate this quarter was
15.0 percent, in line with expectations.
1Q12
Pre-Tax
Income
Taxes on
Earnings
Tax
Rate
As reported
$1,513
$271
17.9%
Specified items
$426
$20
4.7%
Excluding specified items
$1,939
$291
15.0%
Q6)
How did specified items affect reported results?
A6)
Specified items impacted first-quarter results as
follows:
1Q12
(dollars in millions, except earnings-per-share)
Earnings
Pre-tax
After-tax
EPS
As reported (GAAP)
$1,513
$1,242
$0.78
Adjusted for specified items:Acquired IPR&D/R&D
milestone
$200
$200
$0.12
Litigation reserves
$108
$107
$0.07
Restructuring/integration/other
$76
$65
$0.04
Separation costs
$42
$34
$0.02
As adjusted
$1,939
$1,648
$1.03
Acquired in-process research and development (IPR&D) is
related to the agreement with Galapagos to develop and
commercialize an oral, next-generation JAK1 inhibitor. The
R&D milestone payment is related to the Reata Pharmaceuticals
collaboration. Litigation reserves is associated with
previously disclosed litigation.
Restructuring/integration/other is associated with previously
announced restructuring actions and acquisition-related
integration costs. Separation costs are expenses related to
the planned separation of Abbott into two companies.
The impact of specified items by Consolidated Statement of
Earnings line item is as follows (dollars in millions):
1Q12
Cost of
Products
Sold
R&D
Acquired
in-process
R&D
SG&A
Other
(Income)/
Expense
As reported (GAAP)
$3,725
$1,006
$150
$3,000
($71)
Adjusted for specified items:
Acquired IPR&D/R&D milestone
…
($50)
($150)
…
…
Litigation reserves
…
…
…
($108)
…
Restructuring/integration/other
($46)
($11)
…
($15)
($4)
Separation costs
…
…
…
($42)
…
As adjusted
$3,679
$945
…
$2,835
($75)
Q7)
What are the key areas of focus in Abbott's
pipeline?
A7)
In the first quarter of 2012, we made significant
progress in advancing both our pharmaceutical
pipeline, which currently includes more than 20
compounds or new indications in Phase 2 or
Phase 3 development, as well as our diversified
medical products pipeline. Following are highlights:
Hepatitis C
Abbott's antiviral program is focused on
developing treatments for hepatitis C (HCV), a
disease that affects more than 170 million
people worldwide, with approximately 3 to 4
million people newly infected each year.
Abbott's broad-based HCV program includes
three mechanisms of action in Phase 2b
clinical trials, including protease, polymerase
and NS5A inhibitors. Abbott is evaluating
combinations of these compounds, both with and
without the current standard of care, a
strategy that has the potential to markedly
transform current treatment practices by
shortening therapy duration, improving
tolerability and increasing cure rates.
We recently released positive Phase 2
results from two interferon-free studies for
the treatment of HCV. In the study known as
CO-PILOT, ABT-450/r, plus ABT-333 and ribavirin
administered for 12 weeks showed sustained
virological response at 12 weeks post treatment
(SVR12) in 93 percent and 95 percent of
treatment-naïve genotype 1 (GT1) patients. In a
separate study, known as PILOT, 91 percent of
GT1 infected, treatment-naïve patients taking
ABT-450/r and ABT-072 combined with ribavirin
administered for 12 weeks, achieved sustained
viral response at 24 weeks (SVR24). Larger
Phase 2 clinical trials are ongoing, and
we expect to present additional data later this
year.
Chronic Kidney Disease
Bardoxolone, an investigational treatment for
chronic kidney disease (CKD), is a
first-in-class anti-oxidant inflammation
modulator that activates Nrf2, a pathway
involved in the progression of CKD. A global
Phase 3 trial is currently underway. Abbott's
agreement with Reata Pharmaceuticals includes
international rights to bardoxolone, excluding
the U.S. and certain Asian markets.
Also in development for the treatment of CKD is
atrasentan, a compound discovered by Abbott
scientists. A Phase 2b study in patients
with diabetic kidney disease is ongoing with
results expected later this year.
Neuroscience / Pain
Abbott is conducting innovative research in
neuroscience, where it has developed compounds
that target receptors in the brain that help
regulate mood, memory and other neurological
functions. Abbott has a number of compounds in
human studies for conditions such as
schizophrenia, pain, Alzheimer's disease,
Parkinson's disease and multiple sclerosis
(MS).
Abbott's partnership with Biogen Idec
includes development of a novel,
next-generation antibody, daclizumab, which is
currently in Phase 3 clinical trials for
MS.
Additionally, Abbott recently announced
positive results from a Phase 3 trial
evaluating levodopa-carbidopa intestinal gel
(LCIG) for advanced Parkinson's disease. We
expect to submit a U.S. regulatory application
for LCIG this year.
Oncology
Abbott's oncology pipeline includes
therapies that represent promising, unique
scientific approaches to treating cancer.
Abbott is focused on the development of
targeted treatments that inhibit tumor growth
and improve response to common cancer
therapies.
Elotuzumab, an anti-CD37 antibody, is currently
in Phase 3 development with a partner
company for multiple myeloma. Abbott is
evaluating a number of promising mechanisms,
including work on EGFR, Bcl2, PARP, aurora
kinase and cMET, among others.
Immunology
Abbott's scientific experience with HUMIRA
serves as a strong foundation for its
continuing research in immunology. We are
developing several additional indications for
HUMIRA and have a number of next generation
programs underway to address various
immune-mediated conditions, including five
programs in development for rheumatoid
arthritis (RA) alone.
Abbott recently received approval in Europe for
HUMIRA for the treatment of ulcerative colitis.
We also initiated two Phase 3 clinical
trials to evaluate HUMIRA in patients with
hidradenitis suppurativa, a dermatologic
condition for which there are currently no
approved treatments.
In the first quarter, we announced a global
collaboration with Galapagos to develop and
commercialize an oral, next-generation JAK1
inhibitor in Phase 2 development with the
potential to treat RA and other autoimmune
diseases. We are also evaluating a number of
other oral programs including an internal JAK1
candidate and a SYK inhibitor. Additionally, in
late 2011 we announced plans to jointly develop
and commercialize Reata's portfolio of
second-generation oral antioxidant inflammation
modulators, with potential in RA and other
conditions.
Abbott's proprietary DVD-Ig technology
represents an innovative approach that can
target multiple disease-causing antigens with a
single biologic agent. This technology could
lead to next-generation biologic treatments for
complex conditions such as cancer or RA, where
multiple pathways are involved in the disease.
In 2011, we advanced two DVD-Ig molecules into
Phase 1 clinical trials.
Abbott's anti-CD4 biologic, BT-061, in
development in partnership with Biotest, is
currently in Phase 2 clinical trials for
RA and psoriasis.
Women's Health
Elagolix, a novel, first-in-class oral
gonadotropin-releasing hormone (GnRH), is in
development for the treatment of
endometriosis-related pain and fibroids. Abbott
is working in partnership with Neurocrine to
finalize the Phase 3 study design in
endometriosis and a Phase 2 study in
uterine fibroids is underway.
Vascular Devices
Abbott has one of the industry's most robust
vascular pipelines and is working on
well-staged incremental advances and truly
game-changing technologies that have the
ability to restate the market.
Bioresorbable Vascular Scaffold (BVS) - Abbott
has the most advanced BVS clinical program in
the industry. Absorb, the world's first
drug-eluting BVS for the treatment of coronary
artery disease, restores blood flow to the
heart by opening a clogged vessel and providing
support to the vessel until the device
dissolves, leaving patients with a treated
vessel free of a permanent metallic implant.
Absorb is authorized for sale in Europe and is
an investigational device in a number of
countries around the world. We recently
presented two-year data demonstrating
impressive efficacy and safety results for
Absorb for the treatment of coronary and
peripheral artery disease.
MitraClip - MitraClip is a minimally invasive
device for the treatment of select patients
with mitral regurgitation (MR), the most common
valve disease in the world. Significant MR
affects more than 8 million people in the
United States and Europe, and is four times
more prevalent than aortic stenosis.
Abbott's MitraClip system is on the market
in Europe and a number of other countries and
is currently under U.S. FDA review.
Drug Eluting Stents (DES) - Abbott has several
next-generation DES platforms on the market and
in development. In April, XIENCE PRIME received
approval in Japan, and is now available in all
of the major markets worldwide. Also in
development is XIENCE Xpedition, our
next-generation DES that offers a new catheter
for enhanced deliverability, as well as a
broader size matrix. We expect Xpedition to
launch in Europe this year and in the United
States in 2013.
Core Coronary products - Abbott is continuing
to expand its position in the more-than- $2
billion core coronary market. Abbott's
next-generation balloon dilatation catheter,
TREK®, is available in the United States,
Europe and Japan, and we plan to introduce
additional balloon catheter products and
next-generation guide wires within the next few
years.
Endovascular products - Abbott's
endovascular business continues to grow, led by
recent launches of key products including the
Armada peripheral balloon line and the RX
Herculink Elite® Renal Stent System, the
expanded indication for the RX ACCULINK®
Carotid Stent System, and R&D investments in
peripheral artery disease and vessel closure.
Most recently, we announced U.S. FDA approval
of the Absolute Pro Vascular Self-Expanding
Stent System for the treatment of iliac artery
disease, a form of peripheral artery disease
that affects the lower extremities.
Molecular Diagnostics
In March, Abbott obtained CE Mark in Europe for
its rapid, high-throughput PLEX-ID instrument,
along with three assays for use on the system:
PLEX-ID Viral IC Spectrum, PLEX-ID BAC Spectrum
BC and PLEX-ID Flu. PLEX-ID, which is based on
molecular diagnostic technologies, addresses a
significant unmet need for rapid detection and
identification of a broad range of microbes
that cause infections in patients.
Abbott expects to launch more than 15 new
molecular diagnostic products over the next few
years, including several novel oncology and
infectious disease assays.
Core Laboratory Diagnostics
Abbott has launched a number of key assays on
its ARCHITECT® immunochemistry platform, which
will significantly broaden its industry-leading
menu. These tests include assays to assess
ovarian cancer, vitamin deficiencies, and the
first HIV combination assay approved for use in
the United States. Future growth for the Core
Laboratory Diagnostics business will be driven
by differentiated analyzers and comprehensive
automation and informatics solutions to provide
high-quality results and information, while
enhancing laboratory productivity and reducing
costs.
Vision Care
Abbott expects numerous new products and
technology advancements over the next five
years. In its market-leading LASIK business,
Abbott is expanding its proprietary laser
platform into new vision correction
applications, including cataract surgery.
Abbott also continues to expand its portfolio
of premium and standard intraocular lenses
(IOL).
Nutrition
Abbott is focused on improving six areas
through nutrition: immunity, cognition, lean
body mass, inflammation, metabolism and
tolerance. In the first quarter of 2012, Abbott
launched numerous new products in key markets
around the world, including Similac
Stage 1 in India, Similac Total Comfort in
Brazil and Hong Kong, Similac Mom in Taiwan,
Glucerna Triple Care in Vietnam, and Ensure
Clear and PediaSure SideKicks Clear in the
United States. We expect to continue to launch
a number of new products and formulations this
year and have more than 30 clinical studies
underway to demonstrate proven outcomes with
our nutrition innovation.
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