UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
January 21, 2009
Date of Report (Date of earliest event reported)
ABBOTT LABORATORIES
(Exact name of registrant as specified in its charter)
Illinois |
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1-2189 |
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36-0698440 |
(State or other Jurisdiction |
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(Commission File Number) |
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(IRS Employer |
of Incorporation) |
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Identification No.) |
100 Abbott Park Road
Abbott Park, Illinois 60064-6400
(Address of principal executive offices)(Zip Code)
Registrants telephone number, including area code: (847) 937-6100
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 |
Results of Operations and Financial Condition |
On January 21, 2009, Abbott Laboratories announced its results of operations for the fourth quarter and full year 2008.
Furnished as Exhibit 99.1, and incorporated herein by reference, is the news release issued by Abbott announcing those results. In that news release, Abbott uses various non-GAAP financial measures including, among others: net earnings excluding specified items and diluted earnings per common share excluding specified items. These non-GAAP financial measures adjust for factors that are unusual or unpredictable, such as acquisition-related costs, cost reduction initiatives, litigation settlements, acquired in-process research and development and gains and losses related to certain investments. Abbotts management believes the presentation of these non-GAAP financial measures provides useful information to investors regarding Abbotts results of operations as these non-GAAP financial measures allow investors to better evaluate ongoing business performance. Abbotts management also uses these non-GAAP financial measures internally to monitor performance of the businesses. Abbott, however, cautions investors to consider these non-GAAP financial measures in addition to, and not as a substitute for, financial measures prepared in accordance with GAAP.
Item 9.01 |
Financial Statements and Exhibits |
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Exhibit No. |
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Exhibit |
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99.1 |
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Press Release dated January 21, 2009 (furnished pursuant to Item 2.02). |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ABBOTT LABORATORIES |
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Date: |
January 21, 2009 |
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By: |
/s/ Thomas C. Freyman |
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Thomas C. Freyman |
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Executive Vice President, Finance |
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and Chief Financial Officer |
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EXHIBIT INDEX
Exhibit No. |
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Exhibit |
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99.1 |
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Press Release, dated January 21, 2009 (furnished pursuant to Item 2.02). |
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Exhibit 99.1 |
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Abbott Reports Double-Digit Sales and Earnings
Growth in |
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Worldwide Sales Increased 10.1 Percent |
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Adjusted EPS Growth of 14.0 Percent (GAAP EPS up 27.3 Percent) |
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Delivers Double-Digit Sales Growth in Each Major Global Business in 2008 |
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Concludes Successful 2008 with Nine New Major Regulatory Approvals |
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Confirms Double-Digit Earnings-Per-Share Growth in 2009 |
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ABBOTT PARK, III., Jan. 21, 2009 Abbott today announced financial results for the fourth quarter |
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Financial: |
ended Dec. 31, 2008. |
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John Thomas |
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(847) 938-2655
Larry Peepo |
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Diluted earnings per share, excluding specified items, were $1.06, reflecting 14.0 percent growth, in line with Abbotts previous forecast. Diluted earnings per share under Generally Accepted Accounting Principles (GAAP) were $0.98, up 27.3 percent. |
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(847) 935-6722 |
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Worldwide sales increased 10.1 percent to $8 billion, including an unfavorable 2.5 percent effect of exchange rates. Full-year 2008 sales were nearly $30 billion. |
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Tina Ventura |
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(847) 935-9390 |
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Worldwide pharmaceutical sales increased nearly 10 percent driven by double-digit growth in HUMIRA®, Niaspan®, and the TriCor®/TRILIPIX franchise. Global HUMIRA sales in the quarter exceeded $1.3 billion; full-year 2008 global HUMIRA sales were more than $4.5 billion. |
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Media: |
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Melissa Brotz |
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(847) 935-3456 |
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Worldwide medical products sales increased 15.6 percent; with 58.9 percent growth in global vascular sales driven by the continued success of the XIENCE V drug-eluting stent (DES), which became the market-leading DES in the U.S. during the fourth quarter. Last week, Abbott announced the acquisition of Advanced Medical Optics (AMO), strengthening and expanding Abbotts medical device business with a global market leader in ophthalmology. |
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Scott Stoffel |
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(847) 936-9502 |
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Global nutritional sales increased 11.0 percent, up more than 15 percent internationally and nearly 7 percent in the U.S. |
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Abbott is confirming previously issued earnings-per-share guidance for the full-year 2009 of $3.65 to $3.70 under both Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. The midpoint of this 2009 guidance range reflects double-digit growth over 2008 earnings per share. |
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2008 was another highly productive and successful year for Abbott, said Miles D. White, chairman and chief executive officer, Abbott. We significantly outperformed our original growth expectations for the year and added to our diverse portfolio with a significant number of major new product launches. The strategic actions weve taken and our ongoing business momentum position Abbott to deliver continued double-digit growth in 2009. |
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The following is a summary of fourth-quarter 2008 sales.
Sales Summary |
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4Q08 |
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% Change |
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Impact of Exchange |
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Total Sales |
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$ |
7,950 |
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10.1 |
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(2.5 |
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Total U.S. Sales |
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$ |
4,035 |
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12.4 |
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Total International Sales |
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$ |
3,915 |
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7.8 |
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(4.9 |
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Worldwide Pharmaceutical Sales |
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$ |
4,610 |
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9.8 |
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(2.6 |
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U.S. Pharmaceuticals |
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$ |
2,540 |
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10.2 |
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International Pharmaceuticals |
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$ |
2,070 |
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9.5 |
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(5.9 |
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Worldwide Nutritional Sales |
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$ |
1,317 |
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11.0 |
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(1.4 |
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U.S. Nutritionals |
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$ |
656 |
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6.6 |
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International Nutritionals |
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$ |
661 |
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15.6 |
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(2.9 |
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Worldwide Diagnostics Sales |
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$ |
896 |
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4.4 |
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(3.3 |
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U.S. Diagnostics |
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$ |
231 |
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8.8 |
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International Diagnostics |
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$ |
665 |
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2.9 |
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(4.3 |
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Worldwide Vascular Sales |
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$ |
663 |
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58.9 |
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(2.8 |
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U.S. Vascular |
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$ |
396 |
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102.3 |
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International Vascular |
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$ |
267 |
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20.5 |
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(5.2 |
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Other Sales |
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$ |
464 |
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(17.4 |
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(2.2 |
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Note: See Consolidated Statement of Earnings for more information.
2
The following is a summary of sales for the full-year 2008.
Sales Summary |
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FY08 |
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% Change |
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Impact of Exchange |
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Total Sales |
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$ |
29,528 |
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13.9 |
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3.2 |
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Total U.S. Sales |
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$ |
14,170 |
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10.1 |
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Total International Sales |
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$ |
15,358 |
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17.8 |
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6.3 |
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Worldwide Pharmaceutical Sales |
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$ |
16,708 |
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14.2 |
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3.2 |
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U.S. Pharmaceuticals |
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$ |
8,497 |
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8.9 |
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International Pharmaceuticals |
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$ |
8,211 |
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20.3 |
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6.9 |
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Worldwide Nutritional Sales |
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$ |
4,924 |
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12.2 |
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1.9 |
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U.S. Nutritionals |
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$ |
2,479 |
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5.6 |
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International Nutritionals |
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$ |
2,445 |
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19.8 |
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4.0 |
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Worldwide Diagnostics Sales |
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$ |
3,575 |
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13.2 |
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5.1 |
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U.S. Diagnostics |
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$ |
899 |
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9.6 |
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International Diagnostics |
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$ |
2,676 |
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14.5 |
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6.9 |
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Worldwide Vascular Sales |
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$ |
2,241 |
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34.7 |
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3.5 |
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U.S. Vascular |
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$ |
1,205 |
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39.6 |
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International Vascular |
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$ |
1,036 |
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29.4 |
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7.2 |
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Other Sales |
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$ |
2,080 |
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0.3 |
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2.6 |
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Note: See Consolidated Statement of Earnings for more information.
3
The following is a summary of Abbotts fourth-quarter 2008 sales for selected products.
Quarter Ended 12/31/08 |
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Percent |
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Percent |
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Global |
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Percent |
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Pharmaceutical Products |
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HUMIRA |
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$ |
751 |
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42.4 |
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$ |
600 |
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40.5 |
(a) |
$ |
1,351 |
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41.6 |
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TriCor/TRILIPIX |
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$ |
455 |
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16.0 |
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$ |
455 |
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16.0 |
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Kaletra |
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$ |
152 |
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(0.7 |
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$ |
226 |
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3.5 |
(b) |
$ |
378 |
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1.8 |
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Depakote |
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$ |
244 |
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(43.8 |
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$ |
24 |
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(9.1 |
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$ |
268 |
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(41.8 |
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Niaspan |
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$ |
221 |
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23.8 |
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$ |
221 |
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23.8 |
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Lupron |
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$ |
147 |
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n/m |
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$ |
66 |
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(9.6 |
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$ |
213 |
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n/m |
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Ultane/Sevorane |
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$ |
58 |
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15.7 |
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$ |
140 |
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(6.8 |
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$ |
198 |
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(1.2 |
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Biaxin (clarithromycin) |
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$ |
3 |
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n/m |
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$ |
151 |
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(17.8 |
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$ |
154 |
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(22.6 |
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Synthroid |
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$ |
120 |
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(9.4 |
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$ |
22 |
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7.4 |
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$ |
142 |
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(7.1 |
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Nutritional Products |
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Pediatric Nutritionals |
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$ |
333 |
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2.5 |
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$ |
390 |
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29.4 |
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$ |
723 |
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15.4 |
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Adult Nutritionals |
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$ |
295 |
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5.3 |
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$ |
270 |
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0.2 |
(g) |
$ |
565 |
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2.8 |
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Medical Products |
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Abbott Diabetes Care |
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$ |
144 |
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7.1 |
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$ |
193 |
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(3.5 |
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$ |
337 |
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0.7 |
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Coronary Stents |
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$ |
267 |
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245.9 |
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$ |
143 |
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35.5 |
(i) |
$ |
410 |
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124.5 |
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Other Coronary |
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$ |
72 |
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15.0 |
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$ |
83 |
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3.1 |
(j) |
$ |
155 |
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8.3 |
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Endovascular |
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$ |
57 |
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1.3 |
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$ |
41 |
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15.3 |
(k) |
$ |
98 |
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6.7 |
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(a) |
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Without the negative impact of exchange of 9.3 percent, HUMIRA sales increased 49.8 percent internationally. |
(b) |
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Without the negative impact of exchange of 4.9 percent, Kaletra sales increased 8.4 percent internationally. |
(c) |
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Without the negative impact of exchange of 7.5 percent, Lupron sales decreased 2.1 percent internationally. |
(d) |
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Without the negative impact of exchange of 6.2 percent, Sevorane sales decreased 0.6 percent internationally. |
(e) |
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Without the negative impact of exchange of 2.3 percent, clarithromycin sales decreased 15.5 percent internationally. |
(f) |
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Without the negative impact of exchange of 1.3 percent, Pediatric Nutritionals sales increased 30.7 percent internationally. |
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Without the negative impact of exchange of 4.6 percent, Adult Nutritionals sales increased 4.8 percent internationally. |
(h) |
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Without the negative impact of exchange of 5.9 percent, Abbott Diabetes Care sales increased 2.4 percent internationally. |
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Without the negative impact of exchange of 5.2 percent, Coronary Stents sales increased 40.7 percent internationally. |
(j) |
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Without the negative impact of exchange of 4.5 percent, Other Coronary sales increased 7.6 percent internationally. |
(k) |
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Without the negative impact of exchange of 6.7 percent, Endovascular sales increased 22.0 percent internationally. |
n/m = Not meaningful
4
The following is a summary of Abbotts full-year 2008 sales for selected products.
Twelve Months Ended 12/31/08 |
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U.S. |
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Percent |
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Rest of |
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Percent |
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Global |
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Percent |
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Pharmaceutical Products |
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HUMIRA |
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$ |
2,255 |
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36.6 |
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$ |
2,266 |
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60.4 |
(a) |
$ |
4,521 |
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47.6 |
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Kaletra |
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$ |
513 |
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(4.7 |
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$ |
961 |
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22.1 |
(b) |
$ |
1,474 |
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11.2 |
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Depakote |
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$ |
1,262 |
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(14.8 |
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$ |
102 |
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7.4 |
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$ |
1,364 |
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(13.4 |
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TriCor/TRILIPIX |
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$ |
1,341 |
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10.1 |
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$ |
1,341 |
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10.1 |
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Ultane/Sevorane |
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$ |
193 |
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(3.4 |
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$ |
594 |
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6.2 |
(c) |
$ |
787 |
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3.7 |
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Niaspan |
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$ |
786 |
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19.4 |
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$ |
786 |
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19.4 |
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Biaxin (clarithromycin) |
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$ |
14 |
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n/m |
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$ |
637 |
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(7.4 |
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$ |
651 |
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(10.1 |
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Lupron |
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$ |
377 |
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n/m |
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$ |
274 |
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6.5 |
(e) |
$ |
651 |
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n/m |
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Synthroid |
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$ |
435 |
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(5.0 |
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$ |
89 |
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19.2 |
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$ |
524 |
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(1.6 |
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Nutritional Products |
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Pediatric Nutritionals |
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$ |
1,268 |
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2.8 |
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$ |
1,374 |
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25.7 |
(f) |
$ |
2,642 |
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13.6 |
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Adult Nutritionals |
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$ |
1,162 |
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7.8 |
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$ |
1,070 |
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13.0 |
(g) |
$ |
2,232 |
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10.3 |
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Medical Products |
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Abbott Diabetes Care |
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$ |
559 |
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1.1 |
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$ |
794 |
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14.2 |
(h) |
$ |
1,353 |
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8.4 |
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Coronary Stents |
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$ |
669 |
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118.5 |
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$ |
530 |
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44.8 |
(i) |
$ |
1,199 |
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78.4 |
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Other Coronary |
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$ |
298 |
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(0.5 |
) |
$ |
344 |
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13.4 |
(j) |
$ |
642 |
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6.5 |
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Endovascular |
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$ |
238 |
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(7.6 |
) |
$ |
162 |
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24.1 |
(k) |
$ |
400 |
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3.1 |
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(a) |
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Without the positive impact of exchange of 9.7 percent, HUMIRA sales increased 50.7 percent internationally. |
(b) |
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Without the positive impact of exchange of 6.7 percent, Kaletra sales increased 15.4 percent internationally. |
(c) |
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Without the positive impact of exchange of 5.0 percent, Sevorane sales increased 1.2 percent internationally. |
(d) |
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Without the positive impact of exchange of 6.2 percent, clarithromycin sales decreased 13.6 percent internationally. |
(e) |
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Without the positive impact of exchange of 6.1 percent, Lupron sales increased 0.4 percent internationally. |
(f) |
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Without the positive impact of exchange of 3.6 percent, Pediatric Nutritionals sales increased 22.1 percent internationally. |
(g) |
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Without the positive impact of exchange of 4.5 percent, Adult Nutritionals sales increased 8.5 percent internationally. |
(h) |
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Without the positive impact of exchange of 7.1 percent, Abbott Diabetes Care sales increased 7.1 percent internationally. |
(i) |
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Without the positive impact of exchange of 8.0 percent, Coronary Stents sales increased 36.8 percent internationally. |
(j) |
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Without the positive impact of exchange of 6.4 percent, Other Coronary sales increased 7.0 percent internationally. |
(k) |
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Without the positive impact of exchange of 7.0 percent, Endovascular sales increased 17.1 percent internationally. |
n/m = Not meaningful
5
Business Highlights
· Abbott to Acquire Advanced Medical Optics (AMO) Abbott announced an agreement to acquire AMO, an established global leader in the large and growing eye care market. This acquisition strengthens and expands Abbotts current medical device business, providing further diversification for the long term. AMO participates in three segments: cataract surgery, refractive surgery, or LASIK laser vision correction, and eye care products, such as contact lens solutions. AMO holds the number-one market position in LASIK, the number-two position in cataract surgery and the number-three position in eye care products. The ophthalmology market is supported by strong demographic trends, including a large population of people 60 years of age and older, and increased demand for advanced vision care procedures and products.
· Abbott Receives FDA Approval for TRILIPIX The U.S. FDA approved Abbotts TRILIPIX (fenofibric acid), the first fibrate to be approved for use in combination with a statin. The FDA approval of TRILIPIX was based on the largest clinical trial program designed to evaluate the efficacy and safety of a fibrate in combination with various statins.
· Abbott Begins U.S. Study of XIENCE V Designed for Small Vessels Abbott began SPIRIT Small Vessel, a clinical trial evaluating a 2.25 mm size of the XIENCE V Everolimus Eluting Coronary Stent System. The 2.25 mm stent system, to be called Xience Nano in the United States upon FDA approval, would offer physicians an option for treating coronary artery disease in narrower vessels that is based on the proven efficacy, safety and deliverability of XIENCE V. Last year, the XIENCE V 2.25 mm stent system received CE Mark approval and was launched in various countries in Europe, Asia and Latin America.
· HUMIRA® May Help Prevent Further Joint Damage For Up To Five Years Presented new HUMIRA data demonstrating half of patients with moderate to severe early rheumatoid arthritis (RA) showed no progression of joint damage at five years. These results were seen in patients who initially received HUMIRA in combination with methotrexate (MTX) for two years and continued on HUMIRA for an additional three years in an open-label extension study. Five-year results of the PREMIER study found that patients with early RA achieved the best results with an initial combination of HUMIRA and methotrexate.
· HUMIRA Demonstrates Fistula Healing for Up to Three Years in Crohns Patients Presented new HUMIRA data in the long-term treatment of fistulas, with more than half of patients with moderate to severe Crohns disease experiencing fistula healing at three years. Data also showed response to HUMIRA in difficult-to-treat patients those with fistulas who had failed to respond, lost response to, or were intolerant of infliximab.
· TCT Data Presentations Presented results from a new meta-analysis of XIENCE V drug-eluting stent clinical trials, SPIRIT II and SPIRIT III, which showed XIENCE V outperformed Boston Scientifics TAXUS® in key efficacy and safety endpoints out to two years. We also presented new two-year data from our ABSORB trial, which demonstrated that our bioabsorbable drug-eluting stent successfully treated coronary artery disease and absorbed within two years.
· Abbott Exercises Its Option to Acquire IBIS Biosciences Abbott completed the purchase of the remaining equity ownership in IBIS Biosciences, Inc.
6
Abbott confirms double-digit earnings-per-share growth outlook for 2009
Abbott is confirming previously issued earnings-per-share guidance for the full-year 2009 of $3.65 to $3.70 under both Generally Accepted Accounting Principles (GAAP) and on a non-GAAP, or adjusted basis. The midpoint of this 2009 guidance range reflects double-digit growth over 2008 earnings per share.
Abbott declares quarterly dividend; double-digit increase over prior year
On Dec. 12, 2008, the board of directors of Abbott declared the companys quarterly common dividend of 36 cents per share, a 10.8 percent increase over the prior year. The cash dividend is payable Feb. 15, 2009, to shareholders of record at the close of business on Jan. 15, 2009. This marks the 340th 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 more than 68,000 people and markets its products in more than 130 countries.
Abbotts news releases and other information are available on the companys 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 the purposes of the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. Economic, competitive, governmental, technological and other factors that may affect Abbotts 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, 2007, Item 1A, Risk Factors, to Abbotts Quarterly Report on Securities and Exchange Commission Form 10-Q for the quarter ended June 30, 2008 and in Item 1A, Risk Factors, to Abbotts Quarterly Report on Securities and Exchange Commission Form 10-Q for the quarter ended September 30, 2008, 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
7
Abbott Laboratories and Subsidiaries
Consolidated Statement of Earnings
Fourth Quarter Ended December 31, 2008 and 2007
(unaudited)
|
|
2008 |
|
2007 |
|
Percent |
|
|
|
||
Net Sales |
|
$ |
7,950,268,000 |
|
$ |
7,221,351,000 |
|
10.1 |
|
|
|
Cost of products sold |
|
3,178,381,000 |
|
3,161,680,000 |
|
0.5 |
|
|
|
||
Research and development |
|
731,631,000 |
|
662,401,000 |
|
10.5 |
|
|
|
||
Selling, general and administrative |
|
2,297,360,000 |
|
1,879,269,000 |
|
22.2 |
|
|
|
||
Total Operating Cost and Expenses |
|
6,207,372,000 |
|
5,703,350,000 |
|
8.8 |
|
|
|
||
|
|
|
|
|
|
|
|
|
|
||
Operating earnings |
|
1,742,896,000 |
|
1,518,001,000 |
|
14.8 |
|
|
|
||
|
|
|
|
|
|
|
|
|
|
||
Net interest expense |
|
81,045,000 |
|
101,145,000 |
|
(19.9 |
) |
|
|
||
Net foreign exchange (gain) loss |
|
46,395,000 |
|
(1,061,000 |
) |
n/m |
|
|
|
||
(Income) from TAP Pharmaceutical Products Inc. joint venture |
|
|
|
(121,574,000 |
) |
n/m |
|
|
|
||
Other (income) expense, net |
|
(70,750,000 |
) |
56,566,000 |
|
n/m |
|
1 |
) |
||
Earnings from continuing operations before taxes |
|
1,686,206,000 |
|
1,482,925,000 |
|
13.7 |
|
|
|
||
Taxes on earnings from continuing operations |
|
296,483,000 |
|
279,898,000 |
|
5.9 |
|
|
|
||
Earnings from Continuing Operations |
|
$ |
1,389,723,000 |
|
$ |
1,203,027,000 |
|
15.5 |
|
|
|
Gain on sale of discontinued operations, net of tax |
|
146,503,000 |
|
|
|
n/m |
|
2 |
) |
||
|
|
|
|
|
|
|
|
|
|
||
Net Earnings |
|
$ |
1,536,226,000 |
|
$ |
1,203,027,000 |
|
27.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Net Earnings from Continuing Operations Excluding Specified Items, as described below |
|
$ |
1,654,756,000 |
|
$ |
1,452,565,000 |
|
13.9 |
|
3 |
) |
|
|
|
|
|
|
|
|
|
|
||
Diluted Earnings per Common Share from Continuing Operations |
|
$ |
0.89 |
|
$ |
0.77 |
|
15.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Diluted Earnings per Common Share from Gain on Sale of Discontinued Operations |
|
$ |
0.09 |
|
|
|
n/m |
|
2 |
) |
|
|
|
|
|
|
|
|
|
|
|
||
Diluted Earnings per Common Share |
|
$ |
0.98 |
|
$ |
0.77 |
|
27.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Diluted Earnings per Common Share from Continuing Operations Excluding Specified Items, as described below |
|
$ |
1.06 |
|
$ |
0.93 |
|
14.0 |
|
3 |
) |
|
|
|
|
|
|
|
|
|
|
||
Average Number of Common Shares Outstanding Plus Dilutive Common Stock Options and Awards |
|
1,564,235,000 |
|
1,562,664,000 |
|
|
|
|
|
1) Other (income) expense, net, in 2008 includes primarily ongoing contractual payments from Takeda associated with the conclusion of the TAP joint venture. Other (income) expense, net, in 2007 is primarily associated with Abbotts ownership of Boston Scientific stock.
2) Gain on sale of discontinued operations, net of tax, reflects the after-tax gain on the sale of the spine business, which closed during the quarter. This gain has been treated as a specified item and excluded from ongoing earnings as noted below.
3) 2008 Net Earnings Excluding Specified Items excludes after-tax charges of $183 million, or $0.12 per share, for previously announced litigation settlements related to TriCor and $83 million, or $0.05 per share, for cost reduction initiatives, acquisition integration and other, including actions to improve efficiencies in the core diagnostic business. These charges were partially offset by an after-tax gain of $147 million, or $0.09 per share, related to the sale of the spine business.
2007 Net Earnings Excluding Specified Items excludes after-tax charges of $42 million, or $0.03 per share, for acquisition integration, $34 million, or $0.02 per share, for fair-value loss adjustments related to Boston Scientific stock, $26 million, or $0.02, for write-down of Omnicef inventory and $148 million, or $0.09 per share, for cost reduction initiatives and other.
NOTE: See attached questions and answers section for further explanation of Consolidated Statement of Earnings line items.
n/m = Percent change is not meaningful.
8
Abbott Laboratories and Subsidiaries
Consolidated Statement of Earnings
Year Ended December 31, 2008 and 2007
(unaudited)
|
|
2008 |
|
2007 |
|
Percent Change |
|
|
|
||
Net Sales |
|
$ |
29,527,552,000 |
|
$ |
25,914,238,000 |
|
13.9 |
|
|
|
Cost of products sold |
|
12,612,022,000 |
|
11,422,046,000 |
|
10.4 |
|
|
|
||
Research and development |
|
2,688,811,000 |
|
2,505,649,000 |
|
7.3 |
|
|
|
||
Acquired in-process research and development |
|
97,256,000 |
|
|
|
n/m |
|
|
|
||
Selling, general and administrative |
|
8,435,624,000 |
|
7,407,998,000 |
|
13.9 |
|
|
|
||
Total Operating Cost and Expenses |
|
23,833,713,000 |
|
21,335,693,000 |
|
11.7 |
|
|
|
||
|
|
|
|
|
|
|
|
|
|
||
Operating earnings |
|
5,693,839,000 |
|
4,578,545,000 |
|
24.4 |
|
|
|
||
|
|
|
|
|
|
|
|
|
|
||
Net interest expense |
|
327,245,000 |
|
456,390,000 |
|
(28.3 |
) |
|
|
||
Net foreign exchange (gain) loss |
|
84,244,000 |
|
14,997,000 |
|
n/m |
|
|
|
||
(Income) from TAP Pharmaceutical Products Inc. joint venture |
|
(118,997,000 |
) |
(498,016,000 |
) |
(76.1 |
) |
|
|
||
Other (income) expense, net |
|
(454,939,000 |
) |
135,526,000 |
|
n/m |
|
1 |
) |
||
Earnings from continuing operations before taxes |
|
5,856,286,000 |
|
4,469,648,000 |
|
31.0 |
|
|
|
||
Taxes on earnings from continuing operations |
|
1,122,070,000 |
|
863,334,000 |
|
30.0 |
|
|
|
||
Earnings from Continuing Operations |
|
4,734,216,000 |
|
3,606,314,000 |
|
31.3 |
|
|
|
||
Gain on sale of discontinued operations, net of tax |
|
146,503,000 |
|
|
|
n/m |
|
2 |
) |
||
|
|
|
|
|
|
|
|
|
|
||
Net Earnings |
|
$ |
4,880,719,000 |
|
$ |
3,606,314,000 |
|
35.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Net Earnings from Continuing Operations Excluding Specified Items, as described below |
|
$ |
5,186,030,000 |
|
$ |
4,429,146,000 |
|
17.1 |
|
3 |
) |
|
|
|
|
|
|
|
|
|
|
||
Diluted Earnings per Common Share from Continuing Operations |
|
$ |
3.03 |
|
$ |
2.31 |
|
31.2 |
|
3 |
) |
|
|
|
|
|
|
|
|
|
|
||
Diluted Earnings per Common Share from Gain of Sale of Discontinued Operations |
|
$ |
0.09 |
|
|
|
n/m |
|
2 |
) |
|
|
|
|
|
|
|
|
|
|
|
||
Diluted Earnings per Common Share |
|
$ |
3.12 |
|
$ |
2.31 |
|
35.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Diluted Earnings per Common Share from Continuing Operations Excluding Specified Items, as described below |
|
$ |
3.32 |
|
$ |
2.84 |
|
16.9 |
|
3 |
) |
|
|
|
|
|
|
|
|
|
|
||
Average Number of Common Shares Outstanding Plus Dilutive Common Stock Options and Awards |
|
1,560,753,000 |
|
1,560,057,000 |
|
|
|
|
|
1) Other (income) expense, net, in 2008 includes a gain of $94 million in connection with the closing of the TAP Pharmaceutical Products Inc. joint venture transaction and gains of $63 million from the sale of equity investments in Millennium Pharmaceuticals and Boston Scientific. These items have been treated as specified items. The remainder of Other (income) expense, net, is primarily related to ongoing contractual payments from Takeda associated with the conclusion of the TAP joint venture. Other (income) expense, net, in 2007 is primarily associated with Abbotts ownership of Boston Scientific stock.
2) Gain on sale of discontinued operations, net of tax, reflects the after-tax gain on the sale of the spine business, which closed during the fourth quarter. This gain has been treated as a specified item and excluded from ongoing earnings as noted below.
3) 2008 Net Earnings Excluding Specified Items excludes a tax-free gain of $94 million, or $0.06 per share, recorded on the closing of the TAP joint venture transaction, a reduction in income taxes of $30 million, or $0.02 per share, relating to the settlement of an IRS audit, an after-tax gain of $49 million, or $0.03 per share, relating to sales of equity investments in Millennium Pharmaceuticals and Boston Scientific, and an after-tax gain of $147 million, or $0.09 per share, related to the sale of the spine business. These items were offset by after-tax charges of $76 million, or $0.05 per share, for acquired in-process research and development relating to technology investments, $283 million, or $0.18 per share, for cost reduction initiatives, $183 million, or $0.12 per share, for previously announced litigation settlements related to TriCor and $84 million, or $0.05 per share, for acquisition integration, TAP separation and other.
2007 Net Earnings Excluding Specified Items excludes after-tax charges of $206 million, or $0.13 per share, for acquisition integration, $92 million, or $0.06 per share, for a contract termination, $75 million, or $0.05 per share, for fair-value loss adjustments, net of realized gains, related to Boston Scientific stock, $60 million, or $0.04 per share, for write-down of Omnicef inventory, $17 million, or $0.01 per share, for transaction and separation costs relating to the terminated sale of the core laboratory diagnostics business, and $373 million, or $0.24 per share, for cost reduction initiatives and other.
NOTE: See attached questions and answers section for further explanation of Consolidated Statement of Earnings line items.
n/m = Percent change is not meaningful.
9
Questions & Answers
Q1) What drove the 9.8 percent increase in global pharmaceutical sales in the quarter?
A1) U.S. pharmaceutical sales increased 10.2 percent, reflecting double-digit growth for HUMIRA, Niaspan, Ultane and the TriCor/TRILIPIX franchise. U.S. HUMIRA sales increased more than 40 percent, as strong market demand continued across the three major market segments of rheumatology, gastroenterology and dermatology.
Also in the quarter, Abbotts lipid franchise performed well, with growth outpacing the overall cholesterol market as both Niaspan and the TriCor/TRILIPIX franchise achieved double-digit growth. Niaspan increased 23.8 percent with sales of $221 million. TriCor/TRILIPIX franchise sales increased 16.0 percent with sales of $455 million, including the launch of TRILIPIX.
International pharmaceutical sales increased 9.5 percent, including a 5.9 percent negative impact from exchange. International growth was driven by HUMIRA, which increased more than 40 percent, and was up nearly 50 percent excluding the negative impact of foreign exchange, consistent with the performance in previous quarters. Kaletra sales also contributed to growth in the quarter, driven by continued success of the tablet launch in international markets.
Q2) What drove the 15.6 percent increase in global medical products sales and strong global nutritional products sales?
A2) Medical products sales increased 15.6 percent, reflecting 58.9 percent growth in worldwide vascular. In the diagnostic segment, the molecular business delivered continued double-digit sales growth.
Abbott Vascular achieved record sales of $663 million, driven by drug-eluting stent (DES) franchise sales of $332 million. The substantial increase in vascular sales was due to the U.S. approval and successful launch of XIENCE V that began in July 2008. XIENCE V is now the market-leading DES in the U.S. and Europe. We have seen continued steady improvement in the U.S. DES market, with DES penetration in the mid-70s, up more than 15 percentage points from late 2007.
10
Questions & Answers (continued)
Q3) How did specified items affect reported results?
A3) Specified items impacted fourth-quarter results as follows:
|
|
4Q08 |
|
|||||||
(dollars in millions, except earnings-per-share) |
|
Earnings |
|
|
|
|||||
|
|
Pre-tax |
|
After-tax |
|
EPS |
|
|||
As reported |
|
$ |
1,686 |
|
$ |
1,536 |
|
$ |
0.98 |
|
Adjusted for specified items: |
|
|
|
|
|
|
|
|||
Litigation settlements |
|
$ |
226 |
|
$ |
183 |
|
$ |
0.12 |
|
Cost reduction initiatives and other |
|
$ |
101 |
|
$ |
83 |
|
$ |
0.05 |
|
Gain on sale of spine business, net of tax |
|
|
|
$ |
(147 |
) |
$ |
(0.09 |
) |
|
As adjusted |
|
$ |
2,013 |
|
$ |
1,655 |
|
$ |
1.06 |
|
Litigation settlements relate to previously announced TriCor litigation that was resolved during the fourth quarter. Cost reduction initiatives includes previously announced actions to improve efficiencies, including efforts in the core diagnostic business. These charges were partially offset by a gain resulting from the sale of the spine business, which closed in the fourth quarter.
The pre-tax impact of specified items by Consolidated Statement of Earnings line item is as follows (dollars in millions):
|
|
4Q08 |
|
||||||||||
|
|
Cost of |
|
R&D |
|
SG&A |
|
Gain on Sale of |
|
||||
As reported |
|
$ |
3,178 |
|
$ |
732 |
|
$ |
2,297 |
|
$ |
147 |
|
Adjusted for specified items: |
|
|
|
|
|
|
|
|
|
||||
Litigation settlements |
|
|
|
|
|
$ |
(226 |
) |
|
|
|||
Cost reduction initiatives and other |
|
$ |
(69 |
) |
$ |
(13 |
) |
$ |
(19 |
) |
|
|
|
Gain on sale of spine business, net of tax |
|
|
|
|
|
|
|
$ |
(147 |
) |
|||
As adjusted |
|
$ |
3,109 |
|
$ |
719 |
|
$ |
2,052 |
|
|
|
Q4) What drove the investment spending in the quarter?
A4) Combined investment in R&D and SG&A was up 14.3 percent, excluding specified items, and 19.2 percent on a reported basis. Higher-than-expected growth in SG&A included new and ongoing promotional initiatives across multiple businesses, including spending to support the nine new product approvals in 2008. This accelerated level of investment will support continued growth in 2009. Growth in R&D expense reflected continued investment in our broad-based pipeline, including early-to mid-stage opportunities across a number of therapeutic areas, such as oncology, immunology, hepatitis C, neuroscience and vascular devices.
11
Questions & Answers (continued)
Q5) How does the fourth-quarter gross margin ratio compare to the companys guidance?
A5) The gross margin ratio before and after specified items is shown below (dollars in millions):
|
|
4Q08 |
|
||||||
|
|
Cost of Products |
|
Gross |
|
Gross |
|
||
As reported |
|
$ |
3,178 |
|
$ |
4,772 |
|
60.0 |
% |
Adjusted for specified items: |
|
|
|
|
|
|
|
||
Cost reduction initiatives and other |
|
$ |
(69 |
) |
$ |
69 |
|
0.9 |
% |
As adjusted |
|
$ |
3,109 |
|
$ |
4,841 |
|
60.9 |
% |
The adjusted gross margin ratio was 60.9 percent, above our previous forecast, reflecting improved product mix and a favorable impact of foreign exchange on the ratio.
Q6) What was the tax rate in the quarter?
A6) The tax rate this quarter, excluding specified items, was 17.8 percent. The tax rate for the full-year 2008, excluding specified items, was 20.0 percent, consistent with our previous guidance for the full year. As a reminder, the fourth-quarter tax rate included the full-year benefit of the U.S. R&D tax credit since it was enacted retroactively to the beginning of the year during the fourth quarter. The tax rate in the fourth quarter is expected to continue at approximately the same level into 2009. The reported tax rate is reconciled to the ongoing rate below:
|
|
4Q08 |
|
||||||
|
|
Pre-tax |
|
Income |
|
Tax |
|
||
|
|
Income |
|
Tax |
|
Rate |
|
||
From continuing operations, as reported |
|
$ |
1,686 |
|
$ |
296 |
|
17.6 |
% |
Specified items |
|
$ |
327 |
|
$ |
63 |
|
19.0 |
% |
From continuing operations, excluding specified items |
|
$ |
2,013 |
|
$ |
359 |
|
17.8 |
% |
12
Questions & Answers (continued)
Q7) What are some near-term opportunities from Abbotts broad-based pipeline?
A7) Abbotts late-stage pipeline generated nine new regulatory approvals in 2008. Many of these products are in the early stages of launch. Highlights of the near-term opportunities include:
· HUMIRA
· Psoriasis Launched in Europe and the U.S. in 2008.
· RA Japan Launched in 2008.
· Psoriasis Japan Indication filed, under regulatory review.
· Ulcerative colitis Currently in Phase III development.
· TRILIPIX Received fourth-quarter approval of TRILIPIX, Abbotts next-generation fenofibrate. To support TRILIPIX, Abbott executed the largest clinical program to date to evaluate the efficacy and safety of a fibrate in combination with statins. Development continues on a fixed-dose combination of TRILIPIX and CRESTOR to address all three lipid parameters in a single pill. We plan to submit a New Drug Application for this fixed-dose combination in the second half of this year.
· Flutiform Flutiform, a combination asthma treatment in Phase III development, is targeted for an NDA filing in the first quarter of 2009.
· ABT-874 In Immunology, Abbotts anti-IL-12/23 biologic, ABT-874, has demonstrated promising results in early studies for psoriasis and is also being explored as a treatment for Crohns disease. ABT-874 is currently in Phase III development for psoriasis.
· Diabetes Care Pipeline The FreeStyle Freedom Lite no-calibration meter was launched in the United States in 2008. Abbotts FreeStyle Navigator Continuous Glucose Monitoring System was also approved and launched in the United States in the first quarter of 2008.
· XIENCE V In June 2008, Abbott submitted a marketing authorization license application in Japan to gain approval for XIENCE V to treat coronary artery disease. The application for XIENCE V consisted of safety and efficacy data from the SPIRIT III clinical trial, including data from a Japanese patient population. Abbott also expects to launch its next-generation XIENCE V DES in Europe in 2009.
· Core Laboratory Diagnostics In April 2008, Abbott introduced the ARCHITECT i1000SR immunochemistry analyzer in the United States, expanding its ARCHITECT family of diagnostic instrument systems for clinical laboratories. In 2009, we plan to introduce the ARCHITECT c4000, a clinical chemistry analyzer designed for small-to-medium-sized labs. The c4000 is compatible with the i1000, which will allow seamless integration of clinical chemistry and immunoassay testing on one platform.
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Questions & Answers (continued)
Q8) What are some early- and mid-stage opportunities in Abbotts broad-based pipeline?
A8) With the recent productivity of the late-stage pipeline, Abbott is now focused on advancing leading-edge scientific discoveries from its early-to mid-stage development pipeline across the company, where we continue to advance a number of compounds with breakthrough potential.
Our pharmaceutical pipeline has increased in size, novelty and number of phase transitions. In 2008, Phase I or Phase II trial initiations are nearly double 2007 levels. We continue to focus our investment to discover new treatments across a spectrum of therapeutic areas. Select highlights include:
· Oncology
· Abbotts oncology pipeline includes targeted therapies that represent promising, unique scientific approaches to treating cancer. Our collaboration with Genentech to develop two Abbott-discovered compounds continues to progress. These compounds include ABT-869, a multi-targeted kinase inhibitor and ABT-263, a Bcl-2 family protein antagonist.
· Abbotts oncology research also includes a PARP-inhibitor, which prevents DNA repair in cancer cells, enhancing the effectiveness of current cancer therapies.
· Neuroscience
· Abbott is conducting innovative research in neuroscience, where weve developed compounds that target receptors in the brain that help regulate mood, memory and other neurological functions to address conditions such as attention deficit hyperactivity disorder, Alzheimers disease and schizophrenia. Abbott is also working to advance compounds that have the potential to meet the market need for a non-opioid pain therapy. Our work in neuroscience is focused on several promising investigational platforms including NNRs, H3, Calpain and TRPV1, among others.
· Immunology
· Abbotts scientific experience with the anti-TNF biologic HUMIRA serves as a strong foundation for our continuing research in immunology. Products in development for the treatment of immune-mediated diseases are designed to selectively inhibit proteins that are responsible for inflammation. In addition to our work with IL-12/23, we are working to advance development of our early discovery programs, including oral therapies, as well as other potential biologic targets.
· Additionally, our proprietary DVD-ig technology represents an innovative approach that can target multiple disease-causing antigens with a single biologic agent.
· Hepatitis C
· Abbotts antiviral program is focused on the treatment of hepatitis C, a disease that affects more than 170 million people worldwide. Abbott has several active hepatitis C programs including our partnership with Enanta Pharmaceuticals to develop protease inhibitors as well as an internal polymerase program.
· Bioabsorbable Drug-Eluting Stent
· Abbott has presented encouraging two-year data from the worlds first clinical trial for a fully-bioabsorbable DES to treat coronary artery disease. The bioabsorbable DES is designed to be slowly metabolized by the body and completely absorbed over time.
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