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Abbott Reports Fourth-Quarter and Full-Year 2012 Results
* Reuters is not responsible for the content in this press release.
- Fourth-Quarter Ongoing EPS of $1.51 (GAAP EPS of $0.66) -
- Full-Year Ongoing EPS of $5.07 (GAAP EPS of $3.72) -
- Completed Launch of AbbVie, a New Biopharmaceutical Company -
- Company Issues Strong Earnings Outlook for 2013 -
ABBOTT PARK, Illinois, 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 $3.72, including specified items.
-- Excluding foreign exchange, worldwide sales increased 5.6 percent.
Reported sales increased 4.4 percent, including an unfavorable 1.2
percent effect of foreign exchange.
-- On Jan. 1, 2013, Abbott completed the launch of AbbVie, a new
research-based biopharmaceutical company.
-- Abbott launched numerous new products across its diversified businesses
in 2012, positioning the company well for future growth. Key pipeline
innovations include the launch of its Absorb(TM) bioresorbable vascular
scaffold; the next-generation drug-eluting stent, XIENCE Xpedition(TM);
80 launches across its Nutrition business; new tests in Diagnostics; as
well as several new product and geographic expansion initiatives in
Established Pharmaceuticals, Diabetes Care and Vision Care.
"In 2012, we achieved a significant milestone in Abbott's 125-year history with the
creation of AbbVie while delivering another year of strong results," said Miles D.
White, chairman and chief executive officer, Abbott. "Abbott's mix of diversified
healthcare businesses and pipeline is favorably aligned with key healthcare and emerging
market trends, and well positioned to deliver top-tier growth in 2013."
The following is a summary of Fourth-Quarter 2012 sales by major business category.
Sales ($ in millions)
4Q12
---------------------
U.S. Int'l Total
---- ----- -----
Total Sales 4,669 6,168 10,837
----- ----- ------
Proprietary
Pharmaceuticals 3,020 2,122 5,142
Nutritionals 743 972 1,715
Established
Pharmaceuticals -- 1,346 1,346
Core Laboratory
Diagnostics 174 734 908
Molecular
Diagnostics 59 72 131
Point of Care
Diagnostics 72 18 90
Vascular(a) 282 478 760
Diabetes Care 150 212 362
Medical Optics 100 185 285
Other Sales 69 29 98
% Change vs. 4Q11
-----------------
Int'l
-----
U.S. Operational Reported
---- ----------- --------
Total Sales 4.4 6.6 4.4
Proprietary
Pharmaceuticals 7.6 9.6 7.0
Nutritionals 9.4 10.5 10.8
Established
Pharmaceuticals n/a 0.6 (2.4)
Core Laboratory
Diagnostics (0.3) 7.2 4.8
Molecular
Diagnostics (3.3) 12.5 10.4
Point of Care
Diagnostics 19.5 (1.0) (0.8)
Vascular(a) (24.6)(a) 8.1 5.7
Diabetes Care 9.8 0.6 (1.2)
Medical Optics 1.5 1.2 (1.3)
Other Sales (14.7) 4.4 2.3
% Change vs. 4Q11
-----------------
Total
-----
Operational Reported
----------- --------
Total Sales 5.6 4.4
Proprietary
Pharmaceuticals 8.5 7.4
Nutritionals 10.0 10.2
Established
Pharmaceuticals 0.6 (2.4)
Core Laboratory
Diagnostics 5.7 3.8
Molecular
Diagnostics 4.9 3.8
Point of Care
Diagnostics 14.7 14.7
Vascular(a) (6.8)(a) (8.1)(a)
Diabetes Care 4.2 3.1
Medical Optics 1.4 (0.3)
Other Sales (9.9) (10.4)
The following is a summary of Twelve-Month 2012 sales by major business category.
Sales ($ in millions)
12M12
---------------------
U.S. Int'l Total
---- ----- -----
Total Sales 16,784 23,090 39,874
------ ------ ------
Proprietary
Pharmaceuticals 10,158 7,854 18,012
Nutritionals 2,907 3,564 6,471
Established
Pharmaceuticals -- 5,121 5,121
Core Laboratory
Diagnostics 685 2,814 3,499
Molecular
Diagnostics 201 244 445
Point of Care
Diagnostics 274 74 348
Vascular(b) 1,226 1,845 3,071
Diabetes Care 568 759 1,327
Medical Optics 399 698 1,097
Other Sales 366 117 483
% Change vs. 12M11
------------------
Int'l
-----
U.S. Operational Reported
---- ----------- --------
Total Sales 4.8 6.1 1.1
Proprietary
Pharmaceuticals 7.4 8.9 3.0
Nutritionals 9.5 8.1 6.3
Established
Pharmaceuticals n/a 2.1 (4.4)
Core Laboratory
Diagnostics 7.3 6.9 2.5
Molecular
Diagnostics (2.3) 8.3 3.0
Point of Care
Diagnostics 18.1 8.9 7.6
Vascular(b) (20.7)(b) 7.6 3.3
Diabetes Care 4.4 (3.0) (7.5)
Medical Optics 0.7 0.8 (2.4)
Other Sales 6.7 (5.0) (11.3)
% Change vs. 12M11
------------------
Total
-----
Operational Reported
----------- --------
Total Sales 5.5 2.6
Proprietary
Pharmaceuticals 8.2 5.5
Nutritionals 8.7 7.7
Established
Pharmaceuticals 2.1 (4.4)
Core Laboratory
Diagnostics 7.0 3.4
Molecular
Diagnostics 3.3 0.5
Point of Care
Diagnostics 16.0 15.7
Vascular(b) (5.6)(b) (7.9)(b)
Diabetes Care (0.1) (2.8)
Medical Optics 0.8 (1.3)
Other Sales 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.
Sales ($ in millions)
4Q12
---------------------
U.S. Int'l Total
---- ----- -----
HUMIRA 1,413 1,268 2,681
TRILIPIX/
TriCor
(fenofibrate) 202 67 269
AndroGel 364 9 373
Kaletra 83 167 250
Lupron 155 56 211
Niaspan 277 -- 277
Synthroid 168 26 194
Creon 105 83 188
Pediatric
Nutritionals 366 581 947
Adult
Nutritionals 377 391 768
Xience
Drug-
Eluting
Stents(c) 128 272 400
Other
Coronary
Products(d) 49 101 150
Endovascular(e) 59 55 114
% Change vs. 4Q11
-----------------
Int'l
-----
U.S. Operational Reported
---- ----------- --------
HUMIRA 31.1 17.9 15.2
TRILIPIX/
TriCor
(fenofibrate) (50.7) (3.7) (5.2)
AndroGel 40.5 7.5 10.1
Kaletra (17.0) (9.4) (11.4)
Lupron 11.3 (17.4) (18.1)
Niaspan 7.4 n/a n/a
Synthroid 24.9 7.5 3.4
Creon 3.9 13.8 11.8
Pediatric
Nutritionals 8.5 14.1 15.0
Adult
Nutritionals 11.5 5.6 5.2
Xience
Drug-
Eluting
Stents(c) (15.3) 12.6 10.3
Other
Coronary
Products(d) (2.7) 3.0 0.1
Endovascular(e) (3.2) 11.6 9.6
% Change vs. 4Q11
-----------------
Total
-----
Operational Reported
----------- --------
HUMIRA 24.5 23.1
TRILIPIX/
TriCor
(fenofibrate) (43.7) (43.9)
AndroGel 39.5 39.6
Kaletra (12.1) (13.4)
Lupron 1.8 1.6
Niaspan 7.4 7.4
Synthroid 22.2 21.5
Creon 8.0 7.2
Pediatric
Nutritionals 11.9 12.4
Adult
Nutritionals 8.4 8.2
Xience
Drug-
Eluting
Stents(c) 2.0 0.5
Other
Coronary
Products(d) 1.0 (0.9)
Endovascular(e) 3.5 2.6
The following is a summary of Twelve-Month 2012 sales for select products.
Sales ($ in millions)
12M12
---------------------
U.S. Int'l Total
---- ----- -----
HUMIRA 4,376 4,889 9,265
TRILIPIX/
TriCor
(fenofibrate) 1,098 292 1,390
AndroGel 1,152 33 1,185
Kaletra 280 733 1,013
Lupron 569 231 800
Niaspan 911 -- 911
Synthroid 551 105 656
Creon 353 306 659
Pediatric
Nutritionals 1,445 2,080 3,525
Adult
Nutritionals 1,452 1,484 2,936
Xience
Drug-
Eluting
Stents(c) 555 1,044 1,599
Other
Coronary
Products(d) 196 402 598
Endovascular(e) 241 211 452
% Change vs. 12M11
------------------
Int'l
-----
U.S. Operational Reported
---- ----------- --------
HUMIRA 27.7 15.4 8.5
TRILIPIX/
TriCor
(fenofibrate) (19.9) 1.3 (5.2)
AndroGel 31.7 6.7 4.9
Kaletra (14.1) (7.6) (13.2)
Lupron 5.4 (10.5) (14.4)
Niaspan (6.7) n/a n/a
Synthroid 5.7 10.0 1.5
Creon 6.5 10.6 3.5
Pediatric
Nutritionals 14.0 9.1 8.0
Adult
Nutritionals 6.1 6.6 4.0
Xience
Drug-
Eluting
Stents(c) (1.1) 8.5 4.8
Other
Coronary
Products(d) (2.5) 4.1 (0.6)
Endovascular(e) (1.9) 9.0 3.4
% Change vs. 12M11
------------------
Total
-----
Operational Reported
----------- --------
HUMIRA 20.7 16.8
TRILIPIX/
TriCor
(fenofibrate) (16.0) (17.2)
AndroGel 30.9 30.8
Kaletra (9.4) (13.4)
Lupron 0.1 (1.2)
Niaspan (6.7) (6.7)
Synthroid 6.4 5.0
Creon 8.4 5.1
Pediatric
Nutritionals 11.1 10.4
Adult
Nutritionals 6.3 5.0
Xience
Drug-
Eluting
Stents(c) 5.1 2.7
Other
Coronary
Products(d) 1.9 (1.2)
Endovascular(e) 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(TM) 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(TM), 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 [http://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 [http://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 28 400 n/m
development
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 $1.51 $1.45 4.1
2)
Share, Excluding
Specified Items, ===== =====
as described below
Average Number of
Common Shares
Outstanding Plus
Dilutive 1,596 1,577
Common Stock Options and
Awards
Loss on extinguishment of debt are expenses associated
with the early payment of long-term debt as
1) previously discussed.
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
2) 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
2012 Cost of products sold decline was due in part
1) to foreign exchange rates.
2011 Selling, general and administrative expense
includes $1.5 billion of litigation reserves
2) related to previously disclosed litigation.
Loss on extinguishment of debt are expenses
associated with the early payment of long-term
3) debt.
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
4) November 30 year-end.
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
5) below.
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
6) 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 Acquired
Sold R&D IPR&D SG&A
-------- --- -------- ----
As reported (GAAP) $4,060 $1,141 $28 $3,193
Adjusted for specified
items:
Loss on extinguishment of
debt -- -- -- --
Separation costs ($6) ($8) -- ($212)
Asset impairments -- ($58) -- --
Acquired IPR&D -- -- ($28) --
Restructuring/Integration/
Other ($75) ($45) -- ($47)
As adjusted $3,979 $1,030 -- $2,934
4Q12
Net Loss on Other
Interest extinguishment (Income)/
Expense of Debt Expense
-------- -------------- ---------
As reported (GAAP) $163 $1,351 $39
Adjusted for specified
items:
Loss on extinguishment of
debt -- ($1,351) --
Separation costs ($56) -- --
Asset impairments -- -- ($61)
Acquired IPR&D -- -- --
Restructuring/Integration/
Other -- -- ($4)
As adjusted $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-UpRelief(TM) 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.
Abbott
CONTACT: 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
Web site: http://www.abbott.com/
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