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

 

1-2189

 

36-0698440

(State or other Jurisdiction

 

(Commission File Number)

 

(IRS Employer

of Incorporation)

 

 

 

Identification No.)

 

100 Abbott Park Road

Abbott Park, Illinois 60064-6400

(Address of principal executive offices)(Zip Code)

 

Registrant’s 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:

 

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o

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.  Abbott’s management believes the presentation of these non-GAAP financial measures provides useful information to investors regarding Abbott’s results of operations as these non-GAAP financial measures allow investors to better evaluate ongoing business performance.  Abbott’s 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
 
 

 

Exhibit No.

 

Exhibit

 

 

 

 

 
99.1
 
Press Release dated January 21, 2009 (furnished pursuant to Item 2.02).

 

2



 

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.

 

 

 

 

ABBOTT LABORATORIES

 

 

 

 

 

 

 

 

 

 

Date:

January 21, 2009

 

By:

/s/ Thomas C. Freyman

 

 

 

 

Thomas C. Freyman

 

 

 

 

Executive Vice President, Finance

 

 

 

 

and Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Exhibit

 

 

 

99.1

 

Press Release, dated January 21, 2009 (furnished pursuant to Item 2.02).

 

4


Exhibit 99.1

 

Abbott Reports Double-Digit Sales and Earnings Growth in
Fourth Quarter; Confirms Strong Outlook for 2009 Earnings

 

 

 

 

 

 

Worldwide Sales Increased 10.1 Percent

 

– Adjusted EPS Growth of 14.0 Percent (GAAP EPS up 27.3 Percent)

 

Delivers Double-Digit Sales Growth in Each Major Global Business in 2008

 

Concludes Successful 2008 with Nine New Major Regulatory Approvals

 

Confirms Double-Digit Earnings-Per-Share Growth in 2009

 

 

 

 

 

 

ABBOTT PARK, III., Jan. 21, 2009 — Abbott today announced financial results for the fourth quarter

Financial:

ended Dec. 31, 2008.

John Thomas

 

 

 

(847) 938-2655

 

Larry Peepo

·

Diluted earnings per share, excluding specified items, were $1.06, reflecting 14.0 percent growth, in line with Abbott’s previous forecast. Diluted earnings per share under Generally Accepted Accounting Principles (GAAP) were $0.98, up 27.3 percent.

(847) 935-6722

 

 

 

·

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.

Tina Ventura

 

(847) 935-9390

 

 

 

·

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.

Media:

 

Melissa Brotz

 

(847) 935-3456

 

 

 

·

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 Abbott’s medical

device business with a global market leader in ophthalmology.

Scott Stoffel

 

(847) 936-9502

 

 

 

 

 

 

 

 

 

·

Global nutritional sales increased 11.0 percent, up more than 15 percent internationally and nearly 7

percent in the U.S.

 

 

 

 

 

 

·

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.

 

 

 

 

“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 we’ve taken and our ongoing business momentum position Abbott to deliver continued double-digit growth in 2009.

 



 

The following is a summary of fourth-quarter 2008 sales.

 

Sales Summary —
Quarter Ended 12/31/08

 

4Q08
($ millions)

 

% Change
vs. 4Q07

 

Impact of Exchange
on % Change

 

 

 

 

 

 

 

 

 

Total Sales

 

$

7,950

 

10.1

 

(2.5

)

 

 

 

 

 

 

 

 

Total U.S. Sales

 

$

4,035

 

12.4

 

 

 

 

 

 

 

 

 

 

Total International Sales

 

$

3,915

 

7.8

 

(4.9

)

 

 

 

 

 

 

 

 

Worldwide Pharmaceutical Sales

 

$

4,610

 

9.8

 

(2.6

)

 

 

 

 

 

 

 

 

U.S. Pharmaceuticals

 

$

2,540

 

10.2

 

 

 

 

 

 

 

 

 

 

International Pharmaceuticals

 

$

2,070

 

9.5

 

(5.9

)

 

 

 

 

 

 

 

 

Worldwide Nutritional Sales

 

$

1,317

 

11.0

 

(1.4

)

 

 

 

 

 

 

 

 

U.S. Nutritionals

 

$

656

 

6.6

 

 

 

 

 

 

 

 

 

 

International Nutritionals

 

$

661

 

15.6

 

(2.9

)

 

 

 

 

 

 

 

 

Worldwide Diagnostics Sales

 

$

896

 

4.4

 

(3.3

)

 

 

 

 

 

 

 

 

U.S. Diagnostics

 

$

231

 

8.8

 

 

 

 

 

 

 

 

 

 

International Diagnostics

 

$

665

 

2.9

 

(4.3

)

 

 

 

 

 

 

 

 

Worldwide Vascular Sales

 

$

663

 

58.9

 

(2.8

)

 

 

 

 

 

 

 

 

U.S. Vascular

 

$

396

 

102.3

 

 

 

 

 

 

 

 

 

 

International Vascular

 

$

267

 

20.5

 

(5.2

)

 

 

 

 

 

 

 

 

Other Sales

 

$

464

 

(17.4

)

(2.2

)

 

Note:  See “Consolidated Statement of Earnings” for more information.

 

2



 

The following is a summary of sales for the full-year 2008.

 

Sales Summary —
Twelve Months Ended 12/31/08

 

FY08
($ millions)

 

% Change
vs.
FY07

 

Impact of Exchange
on % Change

 

 

 

 

 

 

 

 

 

Total Sales

 

$

29,528

 

13.9

 

3.2

 

 

 

 

 

 

 

 

 

Total U.S. Sales

 

$

14,170

 

10.1

 

 

 

 

 

 

 

 

 

 

Total International Sales

 

$

15,358

 

17.8

 

6.3

 

 

 

 

 

 

 

 

 

Worldwide Pharmaceutical Sales

 

$

16,708

 

14.2

 

3.2

 

 

 

 

 

 

 

 

 

U.S. Pharmaceuticals

 

$

8,497

 

8.9

 

 

 

 

 

 

 

 

 

 

International Pharmaceuticals

 

$

8,211

 

20.3

 

6.9

 

 

 

 

 

 

 

 

 

Worldwide Nutritional Sales

 

$

4,924

 

12.2

 

1.9

 

 

 

 

 

 

 

 

 

U.S. Nutritionals

 

$

2,479

 

5.6

 

 

 

 

 

 

 

 

 

 

International Nutritionals

 

$

2,445

 

19.8

 

4.0

 

 

 

 

 

 

 

 

 

Worldwide Diagnostics Sales

 

$

3,575

 

13.2

 

5.1

 

 

 

 

 

 

 

 

 

U.S. Diagnostics

 

$

899

 

9.6

 

 

 

 

 

 

 

 

 

 

International Diagnostics

 

$

2,676

 

14.5

 

6.9

 

 

 

 

 

 

 

 

 

Worldwide Vascular Sales

 

$

2,241

 

34.7

 

3.5

 

 

 

 

 

 

 

 

 

U.S. Vascular

 

$

1,205

 

39.6

 

 

 

 

 

 

 

 

 

 

International Vascular

 

$

1,036

 

29.4

 

7.2

 

 

 

 

 

 

 

 

 

Other Sales

 

$

2,080

 

0.3

 

2.6

 

 

Note:  See “Consolidated Statement of Earnings” for more information.

 

3



 

The following is a summary of Abbott’s fourth-quarter 2008 sales for selected products.

 

Quarter Ended 12/31/08
(dollars in millions)

 


U.S.
Sales

 

Percent
Change
vs. 4Q07

 


Rest of
World

 

Percent
Change
vs. 4Q07

 

Global
Sales

 

Percent
Change
vs. 4Q07

 

Pharmaceutical Products

 

 

 

 

 

 

 

 

 

 

 

 

 

HUMIRA

 

$

751

 

42.4

 

$

600

 

40.5

(a)

$

1,351

 

41.6

 

TriCor/TRILIPIX

 

$

455

 

16.0

 

 

 

$

455

 

16.0

 

Kaletra

 

$

152

 

(0.7

)

$

226

 

3.5

(b)

$

378

 

1.8

 

Depakote

 

$

244

 

(43.8

)

$

24

 

(9.1

)

$

268

 

(41.8

)

Niaspan

 

$

221

 

23.8

 

 

 

$

221

 

23.8

 

Lupron

 

$

147

 

n/m

 

$

66

 

(9.6

)(c)

$

213

 

n/m

 

Ultane/Sevorane

 

$

58

 

15.7

 

$

140

 

(6.8

)(d)

$

198

 

(1.2

)

Biaxin (clarithromycin)

 

$

3

 

n/m

 

$

151

 

(17.8

)(e)

$

154

 

(22.6

)

Synthroid

 

$

120

 

(9.4

)

$

22

 

7.4

 

$

142

 

(7.1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nutritional Products

 

 

 

 

 

 

 

 

 

 

 

 

 

Pediatric Nutritionals

 

$

333

 

2.5

 

$

390

 

29.4

(f)

$

723

 

15.4

 

Adult Nutritionals

 

$

295

 

5.3

 

$

270

 

0.2

(g)

$

565

 

2.8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medical Products

 

 

 

 

 

 

 

 

 

 

 

 

 

Abbott Diabetes Care

 

$

144

 

7.1

 

$

193

 

(3.5

)(h)

$

337

 

0.7

 

Coronary Stents

 

$

267

 

245.9

 

$

143

 

35.5

(i)

$

410

 

124.5

 

Other Coronary

 

$

72

 

15.0

 

$

83

 

3.1

(j)

$

155

 

8.3

 

Endovascular

 

$

57

 

1.3

 

$

41

 

15.3

(k)

$

98

 

6.7

 

 


(a)

 

Without the negative impact of exchange of 9.3 percent, HUMIRA sales increased 49.8 percent internationally.

(b)

 

Without the negative impact of exchange of 4.9 percent, Kaletra sales increased 8.4 percent internationally.

(c)

 

Without the negative impact of exchange of 7.5 percent, Lupron sales decreased 2.1 percent internationally.

(d)

 

Without the negative impact of exchange of 6.2 percent, Sevorane sales decreased 0.6 percent internationally.

(e)

 

Without the negative impact of exchange of 2.3 percent, clarithromycin sales decreased 15.5 percent internationally.

(f)

 

Without the negative impact of exchange of 1.3 percent, Pediatric Nutritionals sales increased 30.7 percent internationally.

(g)

 

Without the negative impact of exchange of 4.6 percent, Adult Nutritionals sales increased 4.8 percent internationally.

(h)

 

Without the negative impact of exchange of 5.9 percent, Abbott Diabetes Care sales increased 2.4 percent internationally.

(i)

 

Without the negative impact of exchange of 5.2 percent, Coronary Stents sales increased 40.7 percent internationally.

(j)

 

Without the negative impact of exchange of 4.5 percent, Other Coronary sales increased 7.6 percent internationally.

(k)

 

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 Abbott’s full-year 2008 sales for selected products.

 

Twelve Months Ended 12/31/08
(dollars in millions)

 

U.S.
Sales

 

Percent
Change
vs. FY07

 

Rest of
World

 

Percent
Change
vs. FY07

 

Global
Sales

 

Percent
Change
vs. FY07

 

Pharmaceutical Products

 

 

 

 

 

 

 

 

 

 

 

 

 

HUMIRA

 

$

2,255

 

36.6

 

$

2,266

 

60.4

(a)

$

4,521

 

47.6

 

Kaletra

 

$

513

 

(4.7

)

$

961

 

22.1

(b)

$

1,474

 

11.2

 

Depakote

 

$

1,262

 

(14.8

)

$

102

 

7.4

 

$

1,364

 

(13.4

)

TriCor/TRILIPIX

 

$

1,341

 

10.1

 

 

 

$

1,341

 

10.1

 

Ultane/Sevorane

 

$

193

 

(3.4

)

$

594

 

6.2

(c)

$

787

 

3.7

 

Niaspan

 

$

786

 

19.4

 

 

 

$

786

 

19.4

 

Biaxin (clarithromycin)

 

$

14

 

n/m

 

$

637

 

(7.4

)(d)

$

651

 

(10.1

)

Lupron

 

$

377

 

n/m

 

$

274

 

6.5

(e)

$

651

 

n/m

 

Synthroid

 

$

435

 

(5.0

)

$

89

 

19.2

 

$

524

 

(1.6

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nutritional Products

 

 

 

 

 

 

 

 

 

 

 

 

 

Pediatric Nutritionals

 

$

1,268

 

2.8

 

$

1,374

 

25.7

(f)

$

2,642

 

13.6

 

Adult Nutritionals

 

$

1,162

 

7.8

 

$

1,070

 

13.0

(g)

$

2,232

 

10.3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Medical Products

 

 

 

 

 

 

 

 

 

 

 

 

 

Abbott Diabetes Care

 

$

559

 

1.1

 

$

794

 

14.2

(h)

$

1,353

 

8.4

 

Coronary Stents

 

$

669

 

118.5

 

$

530

 

44.8

(i)

$

1,199

 

78.4

 

Other Coronary

 

$

298

 

(0.5

)

$

344

 

13.4

(j)

$

642

 

6.5

 

Endovascular

 

$

238

 

(7.6

)

$

162

 

24.1

(k)

$

400

 

3.1

 

 


(a)

 

Without the positive impact of exchange of 9.7 percent, HUMIRA sales increased 50.7 percent internationally.

(b)

 

Without the positive impact of exchange of 6.7 percent, Kaletra sales increased 15.4 percent internationally.

(c)

 

Without the positive impact of exchange of 5.0 percent, Sevorane sales increased 1.2 percent internationally.

(d)

 

Without the positive impact of exchange of 6.2 percent, clarithromycin sales decreased 13.6 percent internationally.

(e)

 

Without the positive impact of exchange of 6.1 percent, Lupron sales increased 0.4 percent internationally.

(f)

 

Without the positive impact of exchange of 3.6 percent, Pediatric Nutritionals sales increased 22.1 percent internationally.

(g)

 

Without the positive impact of exchange of 4.5 percent, Adult Nutritionals sales increased 8.5 percent internationally.

(h)

 

Without the positive impact of exchange of 7.1 percent, Abbott Diabetes Care sales increased 7.1 percent internationally.

(i)

 

Without the positive impact of exchange of 8.0 percent, Coronary Stents sales increased 36.8 percent internationally.

(j)

 

Without the positive impact of exchange of 6.4 percent, Other Coronary sales increased 7.0 percent internationally.

(k)

 

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 Abbott’s 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 Abbott’s 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 Crohn’s Patients — Presented new HUMIRA data in the long-term treatment of fistulas, with more than half of patients with moderate to severe Crohn’s 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 Scientific’s 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 company’s 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.

 

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 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 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, 2007, Item 1A, “Risk Factors,” to Abbott’s Quarterly Report on Securities and Exchange Commission Form 10-Q for the quarter ended June 30, 2008 and in Item 1A, “Risk Factors,” to Abbott’s 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
Change

 

 

 

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 Abbott’s 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 Abbott’s 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, Abbott’s 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.

 

Worldwide nutritional products sales increased 11 percent, led by 15.6 percent growth in international nutritionals, including a 2.9 percent negative impact from exchange. This reflects continued strong growth in key emerging markets, including Latin America and Asia, where Abbott is opening a new 500,000 square foot state-of-the-art nutritionals manufacturing facility in Singapore in the first quarter. U.S. nutritional sales increased nearly 7 percent, driven primarily by the successful launch of improved formulations of infant nutritionals.

 

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
Products
Sold

 

R&D

 

SG&A

 

Gain on Sale of
Discontinued
Operations

 

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 company’s guidance?

 

A5)                            The gross margin ratio before and after specified items is shown below (dollars in millions):

 

 

 

4Q08

 

 

 

Cost of Products
Sold

 

Gross
Margin

 

Gross
Margin %

 

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 Abbott’s broad-based pipeline?

 

A7)                            Abbott’s 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, Abbott’s 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, Abbott’s 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 Crohn’s 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. Abbott’s 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.

 

13



 

Questions & Answers (continued)

 

Q8)                           What are some early- and mid-stage opportunities in Abbott’s 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

·                  Abbott’s 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.

·                  Abbott’s 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 we’ve 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, Alzheimer’s 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

·                  Abbott’s 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

·                  Abbott’s 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 world’s 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.

 

 

###

 

14