ABBOTT LABORATORIES 
By ABBOTT PARK, Ill., Jan. 25, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) today announced financial results for the fourth quarter ended Dec. 31, 2011.
-- Diluted earnings per share, excluding specified items, were $1.45, at
the high end of Abbott's previous guidance range, reflecting 11.5
percent growth. Diluted earnings per share under Generally Accepted
Accounting Principles (GAAP) were $1.02, including specified items.
-- Worldwide sales increased 4.1 percent to $10.4 billion, including a
favorable 0.2 percent effect of foreign exchange. Emerging markets sales
were $2.5 billion, representing nearly 25 percent of total sales, with
particularly strong growth in Nutritionals, Vascular and Diagnostics.
-- Fourth quarter results included an adjusted gross margin ratio of nearly
64 percent, driven by improved efficiencies across a number of operating
divisions, product mix, and the effect of foreign exchange.
-- In 2011, Abbott continued to advance its broad-based pipeline, and
launched several new products or indications across our Pharmaceuticals,
Medical Products, Nutritionals and Diagnostics businesses.
-- Abbott generated record operating cash flow of more than $9 billion in
2011. The company will resume share repurchase activity in 2012.
"Despite another challenging year for the global economy, Abbott again delivered leading performance, including strong sales and ongoing earnings-per-share growth," said Miles D. White, chairman and chief executive officer, Abbott. "2011 was a significant year for Abbott, with the announced plan to separate into two leading health care companies in research-based pharmaceuticals and diversified medical products, each offering shareholders distinct identities with unique investment opportunities. We remain on track to complete the separation by the end of 2012."
The following is a summary of fourth-quarter 2011 sales by major business category.
% Change vs. 4Q10
-----------------
Sales ($ in
millions) Int'l Total
------------ ----- -----
U.S. Int'l Total U.S. Operational Reported Operational Reported
---- ----- ----- ---- ----------- -------- ----------- --------
Total
Sales 4,471 5,906 10,377 4.3 3.7 4.0 3.9 4.1
----- ----- ------
Proprietary
Pharmaceuticals 2,806 1,974 4,780 5.7 7.4 8.3 6.3 6.7
Nutritionals 679 877 1,556 5.8 10.5 10.8 8.4 8.6
Established
Pharmaceuticals(a) -- 1,389 1,389 n/a (3.3) (4.6) (3.3) (4.6)
Core
Laboratory
Diagnostics 174 701 875 10.1 4.2 4.7 5.3 5.7
Molecular
Diagnostics 60 66 126 9.8 12.2 11.2 11.1 10.6
Point
of
Care
Diagnostics 60 19 79 8.3 5.1 6.5 7.5 7.8
Vascular 374 452 826 (6.3) 4.5 7.0 (0.7) 0.6
Diabetes
Care 136 215 351 7.1 1.5 2.2 3.5 4.0
Medical
Optics 99 187 286 (3.9) 3.3 5.7 0.7 2.2
Other
Sales(b) 83 26 109 (10.8) n/m n/m n/m n/m
The following is a summary of twelve-month 2011 sales by major business category.
% Change vs. 12M10
------------------
Sales ($ in
millions) Int'l Total
------------ ----- -----
U.S. Int'l Total U.S. Operational Reported Operational Reported
---- ----- ----- ---- ----------- -------- ----------- --------
Total
Sales 16,014 22,837 38,851 5.4 9.4 14.3 7.7 10.5
------ ------ ------
Proprietary
Pharmaceuticals 9,455 7,567 17,022 8.1 9.4 14.9 8.7 11.0
Nutritionals 2,653 3,353 6,006 2.5 10.1 13.9 6.6 8.6
Established
Pharmaceuticals(a) -- 5,413 5,413 n/a 15.5 19.8 15.5 19.8
Core
Laboratory
Diagnostics 638 2,745 3,383 6.0 3.7 8.4 4.1 7.9
Molecular
Diagnostics 206 236 442 8.5 16.1 20.7 12.4 14.7
Point
of
Care
Diagnostics 232 69 301 9.7 8.9 12.8 9.5 10.4
Vascular 1,547 1,786 3,333 (6.9) 10.0 16.6 1.2 4.4
Diabetes
Care 544 820 1,364 6.3 2.1 7.4 3.8 7.0
Medical
Optics 396 715 1,111 (2.5) 2.6 8.9 0.7 4.6
Other
Sales(b) 343 133 476 23.6 (27.6) (27.0) 3.4 3.6
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) Established Pharmaceuticals includes sales of branded generics outside
of the United States.
(b) Includes sales primarily from Contract Pharmaceutical Manufacturing
and Animal Health.
n/a = Not applicable
n/m = Percent change is not meaningful.
The following is a summary of fourth-quarter 2011 sales for select products.
% Change vs. 4Q10
-----------------
Sales ($ in millions) Int'l Total
--------------------- ----- -----
U.S. Int'l Total U.S. Operational Reported Operational Reported
---- ----- ----- ---- ----------- -------- ----------- --------
HUMIRA 1,077 1,101 2,178 22.9 8.8 9.8 15.4 15.9
Pediatric
Nutritionals 338 505 843 11.2 14.9 15.3 13.4 13.6
Adult
Nutritionals 338 372 710 1.1 5.0 5.3 3.0 3.2
Coronary
Stents 234 274 508 (5.7) 0.1 3.0 (2.7) (1.2)
TRILIPIX/
TriCor
(fenofibrate) 409 74 483 (2.2) (14.3) (14.8) (4.2) (4.3)
Kaletra 100 188 288 (9.8) (17.9) (18.3) (15.3) (15.6)
Niaspan 258 -- 258 (10.0) n/a n/a (10.0) (10.0)
Lupron 139 69 208 6.9 (0.8) (1.5) 4.2 4.0
Synthroid 134 29 163 2.4 2.5 0.2 2.4 2.0
The following is a summary of twelve-month 2011 sales for select products.
% Change vs. 12M10
------------------
Sales ($ in millions) Int'l Total
--------------------- ----- -----
U.S. Int'l Total U.S. Operational Reported Operational Reported
---- ----- ----- ---- ----------- -------- ----------- --------
HUMIRA 3,427 4,505 7,932 19.3 16.0 22.6 17.4 21.1
Pediatric
Nutritionals 1,268 1,926 3,194 5.0 11.7 14.9 8.8 10.7
Adult
Nutritionals 1,368 1,427 2,795 1.7 8.0 12.6 4.8 7.0
Coronary
Stents 955 1,123 2,078 (8.8) 10.0 17.0 0.1 3.5
TRILIPIX/
TriCor
(fenofibrate) 1,372 320 1,692 1.2 23.6 28.8 4.7 5.5
Kaletra 326 844 1,170 (10.3) (8.9) (5.4) (9.3) (6.8)
Niaspan 976 -- 976 5.3 n/a n/a 5.3 5.3
Lupron 540 270 810 11.8 (3.0) 1.8 6.5 8.2
Synthroid 522 116 638 15.6 7.1 11.5 14.0 14.8
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.
n/a = Not applicable
Business Highlights
Announced Plans to Separate Abbott into Two Leading Health Care Companies
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 pharmaceutical, devices, diagnostic and nutritional businesses, and will retain the Abbott name. The research-based pharmaceutical company will include Abbott's current portfolio of proprietary pharmaceuticals and biologics and will be named later.
Received U.S. Approval for XIENCE PRIME Drug Eluting Stent
Received U.S. Food and Drug Administration (FDA) approval for XIENCE PRIME(TM) for the treatment of coronary artery disease. Abbott now offers an expanded range of drug eluting stents, including long lengths up to 38 mm. XIENCE PRIME features an enhanced stent design and delivery system.
Announced Expanded Collaboration with Reata Pharmaceuticals
Announced plans to jointly develop and commercialize Reata's portfolio of second-generation oral antioxidant inflammation modulators (AIMs). The collaboration includes molecules in a broad range of therapeutic areas, including pulmonary, central nervous system disorders and immunology.
Presented Promising New Data on HCV Compounds
Presented interim results from two Phase 2 studies in Hepatitis C (HCV) patients treated with Abbott's ritonavir-boosted protease inhibitor ABT-450, a polymerase inhibitor and ribavirin for 12 weeks. Early results show very high cure rates were achieved in genotype 1a and 1b patients with only 12 weeks of interferon-free therapy. In addition, we initiated a Phase 2b interferon-free combination study.
Presented New Daclizumab Data at Multiple Sclerosis Congress
Announced with our partner company Biogen Idec additional results from the SELECT Phase 2b trial, the first of two registrational studies designed to evaluate daclizumab high-yield process (DAC HYP) in people with relapsing-remitting multiple sclerosis. Results showed that DAC HYP met the trial's primary endpoint by significantly reducing the annualized relapse rate by 54 percent in the 150 mg dose group and 50 percent in the 300 mg dose group compared to the placebo group at one year.
Secured FDA Clearance for Acute Myeloid Leukemia Test
Received 510(k) clearance from the U.S. FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML). Abbott's Vysis EGR1 FISH Probe Kit is the third Abbott FISH assay approved or cleared this year by the FDA for oncology applications.
Launched New Line of Glucerna Nutrition Products for People with Diabetes
Introduced new Glucerna® Hunger Smart(TM) nutrition shakes and bars for the more than 25 million Americans with diabetes.
Expanded Use of ARCHITECT Platform with Additional Assay Approvals
Received approval in the European Union to market a new diagnostic test for detection of hepatitis B surface antigen (HBsAg), performed on Abbott's ARCHITECT® laboratory testing platform. Additionally, Abbott received clearance from the U.S. FDA for a fully-automated 25-OH Vitamin D assay.
Initiated Clinical Trials to Evaluate Drug Eluting BVS
Announced the initiation of the ABSORB II trial to evaluate the safety, efficacy and performance of the Absorb(TM) bioresorbable vascular scaffold (BVS) compared to XIENCE PRIME. Absorb has CE Mark and is authorized for sale in Europe for the treatment of coronary artery disease. Additionally, we initiated a first-of-its-kind clinical trial in Europe evaluating our novel Esprit(TM) drug-eluting BVS in patients with peripheral artery disease.
Abbott issues ongoing earnings-per-share outlook for 2012
Abbott is issuing ongoing earnings-per-share guidance for the full-year 2012 of $4.95 to $5.05, reflecting another year of strong performance.
Abbott forecasts specified items for the full-year 2012 of approximately $0.35 per share, primarily associated with acquisition integration and cost reduction initiatives. This forecast of specified items excludes one-time costs related to the planned separation of Abbott into two companies, which will be quantified at a later date. Including these specified items, projected earnings per share under Generally Accepted Accounting Principles (GAAP) would be $4.60 to $4.70 for the full-year 2012.
Abbott declares 352nd quarterly dividend
On Dec. 9, 2011, the board of directors of Abbott declared the company's quarterly common dividend of 48 cents per share. The cash dividend is payable Feb. 15, 2012, to shareholders of record at the close of business on Jan. 13, 2012. This marks the 352nd consecutive dividend paid by Abbott since 1924.
About Abbott
Abbott 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's news releases and other information are available on the company's Web site at www.abbott.com. Abbott will webcast its live fourth-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, 2010, 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
Fourth Quarter Ended December 31, 2011 and 2010
(in millions, except per share data)
(unaudited)
2011 2010 % Change
---- ---- --------
Net Sales $10,377 $9,968 4.1
------- ------
Cost of products sold 3,838 4,045 (5.1) 1)
Research and development 1,152 1,058 8.9
Acquired in-process research and
development 400 238 n/m
Selling, general and
administrative 2,905 2,797 3.9
----- -----
Total Operating Cost and Expenses 8,295 8,138 1.9
----- -----
Operating earnings 2,082 1,830 13.8
Net interest expense 102 129 (20.8)
Net foreign exchange (gain) loss (2) (19) n/m
Other (income) expense, net 28 (48) n/m
--- ---
Earnings before taxes 1,954 1,768 10.5
Taxes on earnings 335 327 2.5
--- ---
Net Earnings $1,619 $1,441 12.3
====== ======
Net Earnings Excluding Specified
Items, as described below $2,295 $2,025 13.3 2)
====== ======
Diluted Earnings per Common Share $1.02 $0.92 10.9
===== =====
Diluted Earnings Per Common Share,
Excluding Specified Items,
as described below $1.45 $1.30 11.5 2)
===== =====
Average Number of Common Shares
Outstanding Plus Dilutive
Common Stock Options and Awards 1,577 1,556
Cost of products sold declined across all of Abbott's major
1) businesses as a result of continued efficiency initiatives.
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
2) restructuring and integration charges.
2010 Net Earnings Excluding Specified Items excludes after-
tax charges of $346 million, or $0.23 per share, related
primarily to the acquisitions of Solvay Pharmaceuticals and
Piramal Healthcare Solutions, as well as other cost
reduction initiatives, and $238 million, or $0.15 per share,
relating to acquired in-process research and development
related to the Reata collaboration.
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, 2011 and 2010
(in millions, except per share data)
(unaudited)
2011 2010 % Change
---- ---- --------
Net Sales $38,851 $35,167 10.5
------- -------
Cost of products sold 15,541 14,665 6.0
Research and development 4,129 3,725 10.9
Acquired in-process research and
development 673 313 n/m
Selling, general and
administrative 12,756 10,376 22.9 1)
------ ------
Total Operating Cost and Expenses 33,099 29,079 13.8
------ ------
Operating earnings 5,752 6,088 (5.5)
Net interest expense 445 448 (0.6)
Net foreign exchange (gain) loss (50) (11) n/m
--- ---
Other (income) expense, net 158 (62) n/m 2)
--- ---
Earnings before taxes 5,199 5,713 (9.0)
Taxes on earnings 470 1,087 n/m 3)
--- -----
Net Earnings $4,729 $4,626 2.2
====== ======
Net Earnings Excluding Specified
Items, as described below $7,331 $6,501 12.8 4)
====== ======
Diluted Earnings per Common Share $3.01 $2.96 1.7
===== =====
Diluted Earnings Per Common Share,
Excluding Specified Items,
as described below $4.66 $4.17 11.8 4)
===== =====
Average Number of Common Shares
Outstanding Plus Dilutive
Common Stock Options and Awards 1,567 1,556
2011 Selling, general and administrative expense includes $1.5
billion of litigation reserves related to ongoing settlement
discussions in the previously disclosed investigation by the
U.S. Department of Justice, through the U.S. Attorney for the
Western District of Virginia, related to Depakote. The
discussions are ongoing, and until concluded, there can be no
1) certainty about definitive resolution.
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. This is being treated as
2) a specified item as noted below.
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 prior years' international and U.S.
tax positions. This favorable item is classified as a
specified item and excluded from ongoing results, as
3) discussed below.
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 previously announced
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
4) and U.S. tax positions for $580 million, or $0.37 per share.
2010 Net Earnings Excluding Specified Items excludes after-tax
charges of $1.035 billion, or $0.67 per share, associated
primarily with the acquisitions of Solvay Pharmaceuticals and
Piramal Healthcare Solutions, including announced restructuring
plans, as well as other cost reduction initiatives, $313 million,
or $0.20 per share, relating to acquired in-process research and
development related to the Reata and the Neurocrine
collaborations, $115 million, or $0.07 per share, for the one-
time impact of the devaluation of the Venezuelan bolivar on
balance sheet translation, $106 million, or $0.07 per share, for a
litigation reserve, $60 million, or $0.04 per share, for specific
health care reform impact on deferred tax assets, $88 million, or
$0.06 per share, for costs of a nutritional product recall and the
withdrawal of sibutramine, and $158 million, or $0.10 per share,
for impairment of the intangible asset related to sibutramine.
n/m = Percent change is not meaningful.
Questions & Answers
Q1) What drove sales growth in the quarter?
A1) Worldwide sales increased 4.1 percent to $10.4 billion in the quarter, including a favorable 0.2 percent effect of foreign exchange. With the significant movements in a number of exchange rates during the quarter, the favorable impact from exchange was almost 1 percent lower than our previous forecast.
Worldwide Nutritionals sales increased 8.6 percent in the quarter. International Nutritionals increased 10.8 percent, including 0.3 percent from favorable foreign exchange and driven by continued strong growth in emerging markets. U.S. Nutritionals increased 5.8 percent, with continued double-digit growth in PediaSure® and Ensure®. We also saw steady growth in International Vascular, Diabetes Care, Point of Care Diagnostics and Core Laboratory Diagnostics with continued ARCHITECT system placements. Molecular Diagnostics sales increased double-digits with the launch of new tests and uptake of the Ibis PLEX-ID platform.
Proprietary Pharmaceuticals sales increased 6.7 percent, including 0.4 percent from favorable foreign exchange, driven by strong growth across a number of key franchises in the United States and internationally including HUMIRA®, Androgel®, Creon®, Lupron® and Synthroid®.
Emerging markets sales were $2.5 billion, representing nearly 25 percent of total sales, with particularly strong growth in Nutritionals, Vascular and Diagnostics. In our Established Pharmaceuticals business, we had strong performance in Russia, India and China. In Nutritionals, we saw particularly strong growth in Asia and Latin America, where we are expanding our presence and gaining share with the introduction of new products. In our Vascular business, we had strong growth across many of our key emerging markets, driven by procedure volume and Abbott market share gains. And, in our Diagnostics business, we continue to perform well in Russia and China, where we are placing new ARCHITECT systems and continuing to penetrate the market.
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 pharmaceutical, devices, diagnostic and nutritional businesses, and will retain the Abbott name. The research-based pharmaceutical company will include Abbott's current portfolio of proprietary pharmaceuticals and biologics and will be named later.
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.
The separation process is being led by a dedicated team. 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):
4Q11
----
Cost of Gross Gross
------- ----- -----
Products Margin Margin
-------- ------ ------
Sold %
---- ---
As reported (GAAP) $3,838 $6,539 63.0%
Adjusted for specified items:
Restructuring/integration/other ($83) $83 0.8%
As adjusted $3,755 $6,622 63.8%
------ ------ ----
The adjusted gross margin ratio was 63.8 percent in the fourth quarter, an increase of 320 basis points over the fourth-quarter 2010. This was above our previous outlook for the quarter and driven by efficiency initiatives, favorable product mix, and the effect of foreign exchange.
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 10.2 percent, reflecting continued investment in Abbott's broad-based 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 14.6 percent, in line with expectations.
4Q11
----
Pre-Tax Taxes on Tax
Income Earnings Rate
As reported $1,954 $335 17.1%
Specified items $732 $56 7.7%
---- --- ---
Excluding specified
items $2,686 $391 14.6%
Q6) How did specified items affect reported results?
A6) Specified items impacted fourth-quarter results as follows:
4Q11
----
(dollars in millions, except earnings-
per-share) Earnings
--------
Pre- After- EPS
---- ------ ---
tax tax
--- ---
As reported (GAAP) $1,954 $1,619 $1.02
Adjusted for specified items:
Acquired in-process research and
development $400 $400 $0.25
Restructuring/integration/other $332 $276 $0.18
As adjusted $2,686 $2,295 $1.45
Acquired in-process research and development is related to the agreement with Reata Pharmaceuticals to jointly develop and commercialize Reata's portfolio of second generation oral antioxidant inflammation modulators (AIMs).
Restructuring/integration/other is associated with restructuring and integration costs for the Solvay Pharmaceuticals acquisition. This item also includes previously announced cost reduction initiatives to improve efficiencies in the pharmaceutical, vascular, and core laboratory diagnostics businesses, along with certain new efficiency programs.
The impact of specified items by Consolidated Statement of Earnings line item is as follows (dollars in millions):
4Q11
----
Cost of R&D Acquired SG&A Other
------- --- -------- ---- -----
in-
Products process (Income)/
-------- --------
Sold R&D Expense
---- --- -------
As reported (GAAP) $3,838 $1,152 $400 $2,905 $28
Adjusted for specified
items:
Acquired in-process
research and development -- -- ($400) -- --
Restructuring/integration/
other ($83) ($92) -- ($120) ($37)
---- ---- --- ----- ----
As adjusted $3,755 $1,060 -- $2,785 ($9)
Q7) What are the key areas of focus in Abbott's broad-based pipeline?
A7) We continue to advance our broad-based pipeline. In 2011, we launched several new products or indications, including XIENCE PRIME, XIENCE nano(TM), TREK® Coronary Balloon System, the RX Herculink Elite Renal Stent System, our ALK gene molecular diagnostics test, the FreeStyle® InsuLinx Blood Glucose Monitoring System, Glucerna Hunger Smart shakes and bars, Androgel 1.62%, Creon infant-specific dosage and three new variations of Lupron Depot. We also advanced elotuzumab and bardoxolone into Phase 3 development, and we now have more than 20 compounds or new indications in Phase 2 or Phase 3 development.
Following are highlights from breakthrough research across our pharmaceuticals, medical products and nutritionals pipelines:
-- Hepatitis C
-- Abbott's antiviral program is focused on developing treatments for
hepatitis C (HCV), a disease that affects more than 180 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
expect additional data from our Phase 2b trials to be presented in
2012.
-- Chronic Kidney Disease
-- Bardoxolone, an investigational treatment for chronic kidney disease
(CKD), is a first-in-class anti-inflammatory and anti-oxidant 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 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 in 2012.
-- 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
11 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. Abbott is also continuing
development of an intestinal gel for advanced Parkinson's disease
and expects to submit a U.S. regulatory application in 2012.
-- 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 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 the anti-TNF biologic HUMIRA
serves as a strong foundation for its continuing research in
immunology. Abbott is developing a number of additional indications
for HUMIRA and is working to advance its early discovery programs,
including oral DMARD therapies, and other potential biologic
targets.
-- We recently announced plans to jointly develop and commercialize
Reata's portfolio of second-generation oral antioxidant inflammation
modulators. The global agreement includes a large number of
molecules in a broad range of therapeutic areas, including
pulmonary, central nervous system disorders and immunology.
-- Additionally, 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
combination biologics for complex conditions such as cancer or
rheumatoid arthritis, where multiple pathways are involved in the
disease. We recently advanced two DVD-Ig molecules into Phase 1
clinical trials.
-- 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 was recently
initiated.
-- 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 received CE Mark and is authorized for sale in Europe. In
2011, Abbott initiated several clinical trials, evaluating its BVS
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. With U.S. FDA approvals
in 2011, XIENCE PRIME and XIENCE nano for small vessels are now
available in Europe and in the United States. 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 U.S. 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 Abbott plans 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, the expanded indication for the RX
ACCULINK® Carotid Stent System, and R&D investments in peripheral
artery disease and vessel closure. In 2011, we launched the RX
Herculink Elite Renal Stent System in the U.S. for the treatment of
renal artery stenosis in patients with uncontrolled hypertension. In
2012, we expect to launch the Absolute Pro and Omnilink Elite stents
for iliac indications in the United States.
-- Molecular Diagnostics
-- In 2011, Abbott received U.S. FDA approval and CE Mark for an ALK
gene rearrangement test for non-small-cell lung cancer to be used in
combination with Pfizer's XALKORI (crizotinib), an oral
first-in-class anaplastic lymphoma kinase (ALK) inhibitor. Abbott
also recently received FDA clearance for the Vysis EGR1 FISH Probe
Kit to aid in determining the prognosis of patients with acute
myeloid leukemia. Additionally, Abbott received FDA approval for the
Abbott RealTimePCR HCV assay for measuring viral load, or the amount
of hepatitis C virus in a patient's blood, as well as CE Mark for a
new test to detect cytomegalovirus (CMV), a virus that can lead to
complications in transplant patients and people who are
immunocompromised.
-- 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 2011, Abbott introduced several new products,
including Ensure with Revigor(TM), PediaSure SideKicks(TM),
ZonePerfect® Sweet & Salty nutrition bars, Glucerna Hunger Smart
shakes and bars, and Similac Mom, a nutritional supplement for
pregnant and lactating women. We expect to launch a number of new
products and formulations to consumers in 2012 and are currently
conducting 30 well-controlled clinical trials to demonstrate proven
clinical outcomes with our nutrition innovation.
SOURCE Abbott
