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Abbott Reports Fourth-Quarter and Full-Year 2012 Results
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- Fourth-Quarter Ongoing EPS of $1.51 (GAAP EPS of $0.66) -
ABBOTT PARK, Ill., Jan. 23, 2013 /PRNewswire/ -- Abbott today announced
financial results for the fourth quarter ended Dec. 31, 2012.
* Fourth-quarter diluted earnings per share, excluding specified items, were
$1.51. Diluted earnings per share under Generally Accepted Accounting Principles
(GAAP) were $0.66, including specified items.
* Full-year diluted earnings per share, excluding specified items, were $5.07,
exceeding Abbott's initial guidance range. Diluted earnings per share under GAAP
were $3.72, including specified items.
* Excluding foreign exchange, worldwide sales increased 5.6 percent. Reported
sales increased 4.4 percent, including an unfavorable 1.2 percent effect of
foreign exchange.
* On Jan. 1, 2013, Abbott completed the launch of AbbVie, a new research-based
biopharmaceutical company.
* Abbott launched numerous new products across its diversified businesses in
2012, positioning the company well for future growth. Key pipeline innovations
include the launch of its Absorb™ bioresorbable vascular scaffold; the
next-generation drug-eluting stent, XIENCE Xpedition™; 80 launches across its
Nutrition business; new tests in Diagnostics; as well as several new product and
geographic expansion initiatives in Established Pharmaceuticals, Diabetes Care
and Vision Care.
"In 2012, we achieved a significant milestone in Abbott's 125-year history with
the creation of AbbVie while delivering another year of strong results," said
Miles D. White, chairman and chief executive officer, Abbott. "Abbott's mix of
diversified healthcare businesses and pipeline is favorably aligned with key
healthcare and emerging market trends, and well positioned to deliver top-tier
growth in 2013."
The following is a summary of Fourth-Quarter 2012 sales by major business
category.
% Change vs. 4Q11
Sales ($ in millions) 4Q12 Int'l Total
U.S. Int'l Total U.S. Operational Reported Operational Reported
Total Sales 4,669 6,168 10,837 4.4 6.6 4.4 5.6 4.4
Proprietary Pharmaceuticals 3,020 2,122 5,142 7.6 9.6 7.0 8.5 7.4
Nutritionals 743 972 1,715 9.4 10.5 10.8 10.0 10.2
Established Pharmaceuticals -- 1,346 1,346 n/a 0.6 (2.4) 0.6 (2.4)
Core Laboratory Diagnostics 174 734 908 (0.3) 7.2 4.8 5.7 3.8
Molecular Diagnostics 59 72 131 (3.3) 12.5 10.4 4.9 3.8
Point of Care Diagnostics 72 18 90 19.5 (1.0) (0.8) 14.7 14.7
Vasculara 282 478 760 (24.6)a 8.1 5.7 (6.8)a (8.1)a
Diabetes Care 150 212 362 9.8 0.6 (1.2) 4.2 3.1
Medical Optics 100 185 285 1.5 1.2 (1.3) 1.4 (0.3)
Other Sales 69 29 98 (14.7) 4.4 2.3 (9.9) (10.4)
The following is a summary of Twelve-Month 2012 sales by major business
category.
% Change vs. 12M11
Sales ($ in millions) 12M12 Int'l Total
U.S. Int'l Total U.S. Operational Reported Operational Reported
Total Sales 16,784 23,090 39,874 4.8 6.1 1.1 5.5 2.6
Proprietary Pharmaceuticals 10,158 7,854 18,012 7.4 8.9 3.0 8.2 5.5
Nutritionals 2,907 3,564 6,471 9.5 8.1 6.3 8.7 7.7
Established Pharmaceuticals -- 5,121 5,121 n/a 2.1 (4.4) 2.1 (4.4)
Core Laboratory Diagnostics 685 2,814 3,499 7.3 6.9 2.5 7.0 3.4
Molecular Diagnostics 201 244 445 (2.3) 8.3 3.0 3.3 0.5
Point of Care Diagnostics 274 74 348 18.1 8.9 7.6 16.0 15.7
Vascularb 1,226 1,845 3,071 (20.7)b 7.6 3.3 (5.6)b (7.9)b
Diabetes Care 568 759 1,327 4.4 (3.0) (7.5) (0.1) (2.8)
Medical Optics 399 698 1,097 0.7 0.8 (2.4) 0.8 (1.3)
Other Sales 366 117 483 6.7 (5.0) (11.3) 3.5 1.7
Notes: 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 In the fourth quarter, excluding the expected decline of certain royalty and supply arrangement revenues (including Promus), worldwide operational sales increased 0.7 percent, worldwide reported sales decreased 0.9 percent, and U.S. sales decreased 11.7 percent. This decline in U.S. Vascular sales primarily relates to a decrease in XIENCE sales due to market dynamics and the comparison to 4Q11 when XIENCE PRIME was launched.
b For the full year 2012, excluding the expected decline of certain royalty and supply arrangement revenues (including Promus), worldwide operational sales increased 3.4 percent, worldwide reported sales increased 0.7 percent, and U.S. Vascular sales decreased 3.9 percent.
n/a = Not applicable
The following is a summary of Fourth-Quarter 2012 sales for select products.
% Change vs. 4Q11
Sales ($ in millions) 4Q12 Int'l Total
U.S. Int'l Total U.S. Operational Reported Operational Reported
HUMIRA 1,413 1,268 2,681 31.1 17.9 15.2 24.5 23.1
TRILIPIX/TriCor (fenofibrate) 202 67 269 (50.7) (3.7) (5.2) (43.7) (43.9)
AndroGel 364 9 373 40.5 7.5 10.1 39.5 39.6
Kaletra 83 167 250 (17.0) (9.4) (11.4) (12.1) (13.4)
Lupron 155 56 211 11.3 (17.4) (18.1) 1.8 1.6
Niaspan 277 -- 277 7.4 n/a n/a 7.4 7.4
Synthroid 168 26 194 24.9 7.5 3.4 22.2 21.5
Creon 105 83 188 3.9 13.8 11.8 8.0 7.2
Pediatric Nutritionals 366 581 947 8.5 14.1 15.0 11.9 12.4
Adult Nutritionals 377 391 768 11.5 5.6 5.2 8.4 8.2
Xience Drug-Eluting Stentsc 128 272 400 (15.3) 12.6 10.3 2.0 0.5
Other Coronary Productsd 49 101 150 (2.7) 3.0 0.1 1.0 (0.9)
Endovasculare 59 55 114 (3.2) 11.6 9.6 3.5 2.6
The following is a summary of Twelve-Month 2012 sales for select products.
% Change vs. 12M11
Sales ($ in millions) 12M12 Int'l Total
U.S. Int'l Total U.S. Operational Reported Operational Reported
HUMIRA 4,376 4,889 9,265 27.7 15.4 8.5 20.7 16.8
TRILIPIX/TriCor (fenofibrate) 1,098 292 1,390 (19.9) 1.3 (5.2) (16.0) (17.2)
AndroGel 1,152 33 1,185 31.7 6.7 4.9 30.9 30.8
Kaletra 280 733 1,013 (14.1) (7.6) (13.2) (9.4) (13.4)
Lupron 569 231 800 5.4 (10.5) (14.4) 0.1 (1.2)
Niaspan 911 -- 911 (6.7) n/a n/a (6.7) (6.7)
Synthroid 551 105 656 5.7 10.0 1.5 6.4 5.0
Creon 353 306 659 6.5 10.6 3.5 8.4 5.1
Pediatric Nutritionals 1,445 2,080 3,525 14.0 9.1 8.0 11.1 10.4
Adult Nutritionals 1,452 1,484 2,936 6.1 6.6 4.0 6.3 5.0
Xience Drug-Eluting Stentsc 555 1,044 1,599 (1.1) 8.5 4.8 5.1 2.7
Other Coronary Productsd 196 402 598 (2.5) 4.1 (0.6) 1.9 (1.2)
Endovasculare 241 211 452 (1.9) 9.0 3.4 3.0 0.5
Notes: 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.
c International sales include Abbott's Absorb bioresorbable vascular scaffold (BVS).
d Includes guide wires, balloon catheters and other coronary products.
e Includes vessel closure, carotid stents and other peripheral products.
n/a = Not applicable
Diversified Healthcare Products Business Highlights
Initiated Clinical Trial of Absorb Bioresorbable Vascular Scaffold (BVS)in the
United States
Announced the initiation of the ABSORB III clinical trial in patients in the
U.S. The trial is designed to enroll approximately 2,250 patients and will
compare the performance of Abbott's Absorb BVS, a first-of-its kind device for
the treatment of coronary artery disease, to the company's XIENCE™ family of
drug eluting stents. Data from the ABSORB III trial will support U.S. regulatory
filings for Absorb.
Announced FDA Approval and U.S. Launch of XIENCE Xpedition
Announced the U.S. launch of the XIENCE Xpedition Drug Eluting Stent System,
providing physicians a next-generation technology with the largest size matrix
in the U.S. market. XIENCE Xpedition features a new stent delivery system
designed to optimize deliverability, particularly in challenging coronary
anatomies. XIENCE Xpedition is also available in Europe and other
international markets.
Received Approval for Two New Diagnostic Tests
Announced clearance from the U.S. Food and Drug Administration for ARCHITECT 2nd
Generation Testosterone Assay, a more sensitive, accurate and precise test, that
allows physicians to obtain more reliable measurements of testosterone in both
men and women. In addition, received CE Marking for the ARCHITECT STAT High
Sensitive Troponin-I Assay, which may help clinicians reduce time in diagnosing
heart attacks and assist in determining risk for those who may have future heart
attacks.
Introduced Ensure Complete Shakes for Adults
Introduced in the U.S. Ensure Complete™, a nutritional shake that provides
targeted muscle, heart, immune system, and bone support to help meet adults'
daily dietary needs. Ensure Complete shakes are suitable for gluten-free and
lactose intolerant diets. Ensure Complete shakes feature Abbott's proprietary
ingredient, Revigor®, and 13 grams of protein to help protect, preserve and
promote muscle health.
Received Approval for ALK Test as a Companion Diagnostic in Europe
Announced expansion of the current CE-IVD product labeling for Abbott's Vysis®
ALK Break Apart FISH Probe Kit, allowing the test to be marketed in the European
Union as a companion diagnostic. The test is designed to detect rearrangements
of the ALK gene in advanced non-small cell lung cancer patients who may be
eligible for treatment with XALKORI® (crizotinib), Pfizer's ALK inhibitor.
Proprietary Pharmaceuticals Business Highlights
Presented Data from the Phase 2b Aviator Study in Hepatitis C
Presented the full results from the Phase 2b Aviator study of AbbVie's
investigational all-oral interferon-free regimen for the treatment of hepatitis
C (HCV). Data showed sustained virological response at 12 weeks post treatment
(SVR12) in 98 percent of treatment-naive and 93 percent of null responders
(intent to treat) for genotype 1 (GT1) patients taking a combination of
ABT-450/r, ABT-267, ABT-333 and ribavirin.
Initiated Phase 3 Hepatitis C Registrational Program
Announced details of the Phase 3 clinical trials designed to evaluate safety and
efficacy of a 12-week regimen of three direct-acting antivirals, with and
without ribavirin, for the treatment of HCV in GT1 patients. The Phase 3
program, which is currently open for enrollment, will include more than 2,000
patients with HCV GT1, with trial sites in 29 countries.
Received Approval for Ninth HUMIRA Indication in Europe
Announced approval of HUMIRA® in Europe for the treatment of pediatric
patients with severe active Crohn's disease. With this approval, HUMIRA becomes
the first biologic treatment approved for these patients in more than five
years.This marks the ninth indication for HUMIRA in the European Union.
Abbott issues ongoing earnings-per-share outlook for 2013
Abbott is issuing ongoing earnings-per-share guidance for the full-year 2013 of
$1.98 to $2.04.
Abbott forecasts net specified items for the full-year 2013 of approximately
$0.59 per share, primarily associated with intangible amortization expense,
separation costs and cost-reduction initiatives. Including these net specified
items, projected earnings per share under Generally Accepted Accounting
Principles (GAAP) would be $1.39 to $1.45 for the full-year 2013.
Abbott declares 356th quarterly dividend
On Dec. 14, 2012, the board of directors of Abbott declared the company's
quarterly common dividend of $0.14 per share. Abbott's cash dividend is
payable Feb. 15, 2013, to shareholders of record at the close of business on
Jan. 15, 2013. On Jan. 4, 2013, the board of directors of AbbVie declared the
company's quarterly cash dividend of $0.40 per share. AbbVie's cash dividend
is also payable on Feb. 15, 2013, to shareholders of record at the close of
business on Jan. 15, 2013.
Abbott's annualized cash dividend of $0.56 per share, combined with AbbVie's
annualized cash dividend of $1.60 per share, equals a total annualized cash
dividend of $2.16 per share, compared to the annualized cash dividend of
Abbott, prior to separation, of $2.04 per share. Future quarterly dividends
are subject to approval by each company's board of directors.
About Abbott
Abbott (NYSE: ABT) is a global healthcare company devoted to improving life
through the development of products and technologies that span the breadth of
healthcare. With a portfolio of leading, science-based offerings in diagnostics,
medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves
people in more than 150 countries and employs approximately 70,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.
Abbott will webcast its live fourth-quarter earnings conference call through its
Investor Relations website 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
Abbott's expected financial results after the separation of its research-based
pharmaceutical business. 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 in Item 1A, "Risk Factors," to our quarterly reports filed on
Securities and Exchange Commission Form 10-Q for the quarters ended September
30, 2012 and June 30, 2012, 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, except as required
by law.
Abbott Laboratories and Subsidiaries
Consolidated Statement of Earnings
Fourth Quarter Ended December 31, 2012 and 2011
(in millions, except per share data)
(unaudited)
2012 2011 % Change
Net Sales $10,837 $10,377 4.4
Cost of products sold 4,060 3,838 5.8
Research and development 1,141 1,152 (0.9)
Acquired in-process and collaborations research and development 28 400 n/m
Selling, general and administrative 3,193 2,905 9.9
Total Operating Cost and Expenses 8,422 8,295 1.5
Operating earnings 2,415 2,082 16.0
Net interest expense 163 102 59.6
Loss on extinguishment of debt 1,351 -- n/m 1)
Net foreign exchange (gain) loss (12) (2) n/m
Other (income) expense, net 39 28 38.7
Earnings before taxes 874 1,954 (55.3)
Taxes on earnings (179) 335 n/m
Net Earnings $1,053 $1,619 (34.9)
Net Earnings Excluding Specified Items, as described below $2,421 $2,295 5.5 2)
Diluted Earnings per Common Share $0.66 $1.02 (35.3)
Diluted Earnings per Common Share, Excluding Specified Items, $1.51 $1.45 4.1 2)
as described below
Average Number of Common Shares Outstanding Plus Dilutive 1,596 1,577
Common Stock Options and Awards
1) Loss on extinguishment of debt are expenses associated with the early payment of long-term debt as previously discussed.
2) 2012 Net Earnings Excluding Specified Items excludes after-tax charges of $858 million, or $0.54 per share, for loss on extinguishment of debt, $265 million, or $0.16 per share, for separation costs, $97 million, or $0.06 per share, for asset impairments, $122 million, or $0.07 per share, for restructuring, integration costs and other and $26 million, or $0.02 per share, for acquired in-process research and development.
2011 Net Earnings Excluding Specified Items excludes after-tax charges of $400 million, or $0.25 per share, relating to acquired in-process research and development related to the Reata collaboration, $124 million, or $0.08 per share, associated with the acquisition of Solvay Pharmaceuticals, and $152 million, or $0.10 per share, for other restructuring and integration charges.
NOTE: See attached questions and answers section for further explanation of Consolidated Statement of Earnings line items.
n/m = Percent change is not meaningful.
Abbott Laboratories and Subsidiaries
Consolidated Statement of Earnings
Twelve Months Ended December 31, 2012 and 2011
(in millions, except per share data)
(unaudited)
2012 2011 % Change
Net Sales $39,874 $38,851 2.6
Cost of products sold 15,120 15,541 (2.7) 1)
Research and development 4,322 4,129 4.7
Acquired in-process and collaborations research and development 288 673 n/m
Selling, general and administrative 12,059 12,756 (5.5) 2)
Total Operating Cost and Expenses 31,789 33,099 (4.0)
Operating earnings 8,085 5,752 40.6
Net interest expense 513 445 15.3
Loss on extinguishment of debt 1,351 -- n/m 3)
Net foreign exchange (gain) loss (8) (50) n/m
Other (income) expense, net (34) 158 n/m 4)
Earnings before taxes 6,263 5,199 20.5
Taxes on earnings 300 470 (36.3) 5)
Net Earnings $5,963 $4,729 26.1
Net Earnings Excluding Specified Items, as described below $8,119 $7,331 10.7 6)
Diluted Earnings per Common Share $3.72 $3.01 23.6
Diluted Earnings per Common Share, Excluding Specified Items, $5.07 $4.66 8.8 6)
as described below
Average Number of Common Shares Outstanding Plus Dilutive 1,592 1,567
Common Stock Options and Awards
1) 2012 Cost of products sold decline was due in part to foreign exchange rates.
2) 2011 Selling, general and administrative expense includes $1.5 billion of litigation reserves related to previously disclosed litigation.
3) Loss on extinguishment of debt are expenses associated with the early payment of long-term debt.
4) Other (income) expense, net for 2011 includes a charge of $137 million for the impact of Abbott's change to a calendar year end for the international operations that were previously reported on a November 30 year-end.
5) 2012 Taxes on earnings includes a favorable adjustment to tax expense of $408 million, or $0.26 per share, as a result of the resolution of various tax positions from a previous year. 2011 Taxes on earnings includes a favorable adjustment to tax expense of
$580 million, or $0.37 per share, as a result of the resolution of various international and U.S. tax positions from prior years. These favorable items are classified as specified items and excluded from ongoing results, as discussed below.
6) 2012 Net Earnings Excluding Specified Items excludes after-tax charges of $858 million, or $0.54 per share, for loss on extinguishment of debt, $573 million, or $0.36 per share, for restructuring, $485 million, or $0.30 per share, for separation costs,
$325 million, or $0.21 per share, for acquired in-process R&D and R&D milestone payments, $115 million, or $0.07 per share, related to litigation reserves, $112 million, or $0.07 per share, for integration-related expenses and $96 million, or $0.06 per
share, for asset impairments. These items were partially offset by a favorable adjustment from the resolution of a prior year's tax positions for $408 million, or $0.26 per share.
2011 Net Earnings Excluding Specified Items excludes after-tax charges of $1.454 billion, or $0.92 per share, related to litigation reserves, $673 million, or $0.43 per share, relating to acquired in-process research and development related to the Reata
and Biotest collaborations, $341 million, or $0.22 per share, associated with the acquisition of Solvay Pharmaceuticals, $76 million, or $0.05 per share, for the impairment of an R&D intangible asset, $137 million, or $0.09 per share, for the 2009 and 2010
impact of the change to a calendar year end for international operations, $110 million, or $0.07 per share, for restructuring in the pharmaceutical business, $311 million, or $0.19 per share, for cost reduction initiatives and other, and $80 million, or
$0.05 per share, for other litigation reserves. These items were partially offset by a favorable adjustment from the resolution of prior years' international and U.S. tax positions for $580 million, or $0.37 per share.
n/m = Percent change is not meaningful.
Questions & Answers
Q1) What were sources of sales growth in the quarter?
A1) Excluding foreign exchange, worldwide sales increased 5.6 percent. Reported
sales increased 4.4 percent, including an unfavorable 1.2 percent effect of
foreign exchange. In emerging markets, sales increased more than 10 percent,
excluding foreign exchange, with strong double-digit growth in many of the key
emerging markets across Abbott's businesses.
Worldwide Nutrition sales increased 10.0 percent in the quarter, excluding a
favorable 0.2 percent effect of foreign exchange. This was driven by strong
growth across the U.S. and International Nutrition businesses, increasing 9.4
percent and 10.5 percent (excluding foreign exchange), respectively, driven by
growth of key products, including Similac®, PediaSure®, Ensure® and Glucerna®,
as well as emerging market growth. Sales in emerging markets represent more than
40 percent of total Nutrition sales and increased double digits. Global sales of
Core Laboratory Diagnostics increased 5.7 percent, excluding an unfavorable 1.9
percent effect of foreign exchange, driven by 7.2 percent international growth,
excluding an unfavorable 2.4 percent effect of foreign exchange, with strong
growth in key emerging markets, such as China, Russia and Brazil. Point of
Care Diagnostics also contributed to strong sales growth, increasing double
digits in the quarter.
Worldwide Proprietary Pharmaceuticals sales increased 8.5 percent, excluding an
unfavorable 1.1 percent effect of foreign exchange, driven by strong growth in
key franchises including HUMIRA worldwide and AndroGel® in the U.S., partially
offset by the impact of Tricor® generic competition in the U.S.
Q2) How did specified items affect reported results?
A2) Specified items impacted fourth-quarter results as follows:
4Q12
(dollars in millions, except earnings-per-share) Earnings
Pre-tax After-tax EPS
As reported (GAAP) $874 $1,053 $0.66
Adjusted for specified items:
Loss on extinguishment of debt $1,351 $858 $0.54
Separation costs $282 $265 $0.16
Asset impairments $119 $97 $0.06
Acquired IPR&D $28 $26 $0.02
Restructuring/Integration/Other $171 $122 $0.07
As adjusted $2,825 $2,421 $1.51
Loss on extinguishment of debt relates to the payment of long-term debt as
discussed previously. Separation costs are expenses related to the separation of
AbbVie. Asset impairments relate to the write down of certain acquired research
and development assets and equity investments. Acquired IPR&D relates to a
previously announced Proprietary Pharmaceuticals collaboration.
Restructuring/Integration/Other is associated primarily with previously
announced restructuring actions across the businesses. The impact of the
specified items by line item is as follows (dollars in millions):
4Q12
Cost of Products Sold R&D Acquired IPR&D SG&A Net Interest Expense Loss on Other (Income)/
extinguishment
Expense
of Debt
As reported (GAAP) $4,060 $1,141 $28 $3,193 $163 $1,351 $39
Adjusted for specified items:
Loss on extinguishment of debt -- -- -- -- -- ($1,351) --
Separation costs ($6) ($8) -- ($212) ($56) -- --
Asset impairments -- ($58) -- -- -- -- ($61)
Acquired IPR&D -- -- ($28) -- -- -- --
Restructuring/Integration/Other ($75) ($45) -- ($47) -- -- ($4)
As adjusted $3,979 $1,030 -- $2,934 $107 -- ($26)
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):
4Q12
Cost of Gross Gross
Products
Margin
Margin
Sold
%
As reported (GAAP) $4,060 $6,777 62.5%
Adjusted for specified items:
Restructuring/Integration/Other ($81) $81 0.8%
As adjusted $3,979 $6,858 63.3%
The adjusted gross margin ratio was 63.3 percent in the fourth quarter, a
decrease of 50 basis points from the prior year quarter due to the negative
impact of foreign exchange of 130 basis points.
Q4) What was the tax rate?
A4) The ongoing tax rate for the full year was 14.8 percent, in line with
previous guidance, as detailed below (dollars in millions):
12M12
Pre-Tax Taxes on Tax
Income Earnings Rate
As reported (GAAP) $6,263 $300 4.8%
Specified items $3,266 $1,110 34.0%
Excluding specified items $9,529 $1,410 14.8%
The ongoing tax rate for the fourth quarter was 14.3 percent, as detailed
below.
4Q12
Pre-Tax Taxes on Tax
Income Earnings Rate
As reported (GAAP) $874 ($179) (20.5%)
Specified items $1,951 $583 29.9%
Excluding specified items $2,825 $404 14.3%
Q5) What are the key areas of focus in Abbott's diversified medical products
pipeline?
A5) Abbott's diversified medical products pipeline includes revolutionary
medical technologies, next-generation diagnostic systems, new formulations, new
packaging, new flavors and other brand enhancements. Following are highlights:
* Vascular Devices
* Abbott has one of the industry's most robust vascular pipelines and is working
on well-staged incremental advances and transformational technologies that have
the potential to restate the market.
* Drug Eluting Stents (DES) - Abbott is the global leader in drug eluting
stents with several leading products on the market and next-generation platforms
in development. XIENCE Xpedition, our next-generation DES technology, features a
new stent delivery system for enhanced deliverability as well as a broader size
matrix. XIENCE Xpedition was launched in the U.S. earlier this month and also is
available in Europe and parts of Asia and Latin America. We expect to
launch XIENCE Xpedition in additional markets this year.
* Bioresorbable Vascular Scaffold (BVS) - Absorb is the world's first drug
eluting BVS for the treatment of coronary artery disease. It 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 that may
resume more natural function and movement because it is free of a permanent
metallic stent. Absorb is now launched in more than 30 countries across Europe
and parts of Latin America and Asia, including India. In January, Abbott
announced the initiation of its U.S. clinical trial, ABSORB III, which will be
used to support the U.S. regulatory filing of Absorb.
* Endovascular products - Abbott's endovascular business key product launches
in 2012 included the Absolute Pro® Vascular Self-Expanding Stent System and the
Omnilink Elite® Vascular Balloon-Expandable Stent System, both for the
treatment of iliac artery disease, a form of peripheral artery disease (PAD)
that affects the lower extremities. We continue to develop innovative products
to treat PAD and expand indications for stents and vessel closure systems.
* MitraClip - MitraClip® is a less invasive device for the treatment of select
patients with mitral regurgitation (MR), the most common valve disease in the
world. 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 available in Europe and parts of Asia and is currently under U.S. FDA
review.
* Nutrition
* Abbott is focused on six key areas through nutrition: immunity, cognition,
lean body mass, inflammation, metabolism and tolerance. Through these platforms,
we are helping to solve global health needs with nutrition science that matters
to our customers. Demographic shifts also shape our innovation pipeline, as we
focus on new and existing technologies to support the challenges of an aging
population, including malnutrition, increase in chronic disease and the targeted
needs of critical care. We have initiated more than 100 clinical trials over the
last three years.
* We have expanded our R&D capabilities, reduced innovation cycle times and
accelerated product introductions. In 2012 we launched 80 products in key
markets around the world. We're also expanding R&D infrastructure closer to our
customers to deliver relevant regional innovation, and building external
partnerships to expand on our core capabilities and identify emerging
technologies.
* Key highlights from the second half of 2012 include:
* Continued the global roll-out of Similac Total Comfort with four additional
launches in key markets: Hong Kong, Taiwan, Malaysia and Russia. With these
launches, Similac Total Comfort is now available in 19 key international
markets.
* Initiated the global introduction of specialty tolerance products with first
market launches of Similac Alimentum® in Singapore and Similac Spit-Up
Relief™ in Saudi Arabia.
* Continued to build our portfolio in India with the launch of Similac Stage
2 and HQPro, a protein powder product.
* Completed the U.S. launch of Myoplex® Original and Lite Ready-To-Drink with
Revigor®, Similac Liquid Protein Fortifier, as well as a ZonePerfect® brand
redesign.
* Established Pharmaceuticals
* Abbott's large and growing portfolio of hundreds of established
pharmaceuticals consists of trusted, well-known brands that have broad use
throughout the world. Our strategy is focused on increasing access and being
closer to patients and other customers by operating locally in each market and
building country-specific portfolios made up of global and local pharmaceutical
brands that best meet each local market's needs.
* We continue to strengthen the depth and breadth of our established
pharmaceuticals portfolio across several therapeutic areas including
gastroenterology, women's health, cardiology, metabolic disorders and primary
care. This includes launching new and improved formulations of our current
trusted brands, such as Creon and Brufen, as well as launching new products,
such as Amitiza®, a prescription medicine for the treatment of chronic
constipation, which recently launched in Japan.
* Over the next several years, we expect to bring these medicines to broader
patient populations through registrations across multiple geographies, including
key emerging markets.
* Diagnostics
* Abbott is focusing on near-term launches of important automation solutions,
such as its next-generation track system called ACCELERATOR a3600, to help
improve efficiencies in the laboratory. These important innovations will play a
critical role in reducing the time it takes for a test result to be delivered to
the physician to aid in patient diagnosis. Recent launches include two new tests
for the ARCHITECT platform: an innovative, highly sensitive troponin assay
available outside the U.S. and a second-generation testosterone assay now
available worldwide. Additionally, Abbott expects to launch assays in the areas
of cardiac care, fertility, metabolics and infectious disease later this year,
which will further broaden and differentiate its industry-leading menu.
* Future growth for the Core Laboratory Diagnostics business will be driven by
its next-generation blood screening, hematology and immunochemistry analyzers,
as well as advanced automation and informatics solutions to provide high-quality
results and information, while enhancing laboratory productivity and reducing
costs.
* Abbott expects to launch more than 15 new molecular diagnostic products over
the next few years, including several novel oncology, infectious disease and
companion diagnostic assays.
* Vision Care
* Abbott expects numerous new products and technology advancements over the next
five years from its cataract, refractive and corneal business units. 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 cataract technologies which
includes intraocular lenses (IOLs), phacoemulsification systems and
viscoelastics.
* Key highlights of 2012 include:
* Completed the European launch of the TECNIS® Multifocal Toric 1-Piece IOL,
which is the latest advancement in the TECNIS portfolio of high-quality IOLs.
The TECNIS iTec Preloaded Delivery System, also launched in Europe, allows a
cataract surgeon to implant the TECNIS 1-Piece IOL safely into the eye through a
smaller incision.
* Received U.S. FDA clearance to use Abbott's iFS Advanced Femtosecond Laser in
cataract surgery, giving surgeons the ability to make precise, bladeless
bow-shaper or curved arcuate incisions during surgery and customize for each
individual patient.
* Received FDA approval of Healon® EndoCoat OVD, a device intended for use as a
surgical aid in cataract extraction and IOL implantation.
* Launched in Europe and Japan the iDesign Advanced WaveScan Studio
aberrometer, a next-generation diagnostic tool for mapping and analyzing corneal
aberrations in the eye.
SOURCE Abbott
Abbott, Financial, Brian Yoor, +1-847-937-6343, or Tina Ventura,
+1-847-935-9390, or Media, Melissa Brotz, +1-847-935-3456, or Scott Stoffel,
+1-847-936-9502, or AbbVie, Financial, Larry Peepo, +1-847-935-6722, or Media,
Adelle Infante, +1-847-938-8745
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