Abbott Laboratories (ABT), (founding name: Abbott Alkaloid Company) is a global pharmaceutical company with around 73,000 employees in 150 countries. Abbott was founded in 1888 by Wallace C. Abbott (1857-1921) and is headquartered in Abbott Park, a northern suburb of Chicago, Illinois.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 10-Q
(Mark One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2008
OR
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
For the transition period from to
Commission File No. 1-2189
ABBOTT LABORATORIES
An Illinois Corporation
I.R.S. Employer Identification No.
36-0698440
100 Abbott Park Road
Abbott Park, Illinois 60064-6400
Telephone: (847) 937-6l00
Indicate by check mark whether the registrant: (l) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of l934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer x
Accelerated filer o
Non-accelerated filer o
Smaller reporting company o
(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
As of June 30, 2008, Abbott Laboratories had 1,541,546,885 common shares without par value outstanding.
PART I. FINANCIAL INFORMATION
Abbott Laboratories and Subsidiaries
Condensed Consolidated Financial Statements
(Unaudited)
Condensed Consolidated Statement of Earnings
(dollars and shares in thousands except per share data)
Three Months Ended
Six Months Ended
June 30
2008
2007
Net Sales
$
7,314,021
6,370,620
14,079,624
12,316,181
Cost of products sold
3,119,700
2,804,326
6,080,772
5,396,337
Research and development
656,863
583,474
1,276,820
1,202,530
Acquired in-process research and development
78,556
97,256
Selling, general and administrative
2,052,317
1,796,456
4,070,350
3,583,325
Total Operating Cost and Expenses
5,907,436
5,184,256
11,525,198
10,182,192
Operating Earnings
1,406,585
1,186,364
2,554,426
2,133,989
Interest expense
137,769
153,349
280,303
300,891
Interest (income)
(54,448
)
(28,533
(103,804
(51,870
(Income) from TAP Pharmaceutical Products Inc. joint venture
(17,055
(115,726
(118,997
(262,358
Net foreign exchange loss (gain)
14,472
6,248
20,693
11,099
Other (income) expense, net
(310,471
(81,612
(320,813
42,924
Earnings Before Taxes
1,636,318
1,252,638
2,797,044
2,093,303
Taxes on Earnings
314,304
263,894
537,163
407,022
Net Earnings
1,322,014
988,744
2,259,881
1,686,281
Basic Earnings Per Common Share
0.86
0.64
1.47
1.09
Diluted Earnings Per Common Share
0.85
0.63
1.45
1.08
Cash Dividends Declared Per Common Share
0.36
0.325
0.72
0.65
Average Number of Common Shares Outstanding Used for Basic Earnings Per Common Share
1,539,786
1,541,717
1,541,909
1,541,339
Dilutive Common Stock Options and Awards
13,609
18,950
15,076
18,435
Average Number of Common Shares Outstanding Plus Dilutive Common Stock Options and Awards
1,553,395
1,560,667
1,556,985
1,559,774
Outstanding Common Stock Options Having No Dilutive Effect
48,423
4,639
6,399
The accompanying notes to condensed consolidated financial statements are an integral part of this statement.
2
Condensed Consolidated Statement of Cash Flows
(dollars in thousands)
Cash Flow From (Used in) Operating Activities:
Net earnings
Adjustments to reconcile earnings to net cash from operating activities
Depreciation
534,626
463,724
Amortization of intangible assets
383,088
404,201
Share-based compensation
219,793
250,198
Gain on dissolution of TAP Pharmaceutical Products Inc. Joint Venture
(94,656
Trade receivables
(53,079
38,724
Inventories
(35,087
1,001
Other, net
(248,196
(248,387
Net Cash From Operating Activities
3,063,626
2,595,742
Cash Flow From (Used in) Investing Activities:
Acquisitions of property and equipment
(703,327
(839,850
Proceeds from sales of Boston Scientific common stock
318,645
302,015
(Purchases of) proceeds from sales of other investment securities, net
(1,209,203
(14,377
Other
(87,322
2,573
Net Cash (Used in) Investing Activities
(1,681,207
(549,639
Cash Flow From (Used in) Financing Activities:
Proceeds from issuance of short-term debt and other
1,699,869
212,721
Payments of long-term debt
(200,000
(347,704
Purchases of common shares
(1,071,435
(863,470
Proceeds from stock options exercised, including tax benefit
463,169
914,134
Dividends paid
(1,060,186
(954,559
Net Cash (Used in) Financing Activities
(168,583
(1,038,878
Effect of exchange rate changes on cash and cash equivalents
126,366
10,514
Net Increase in Cash and Cash Equivalents
1,340,202
1,017,739
Cash and Cash Equivalents, Beginning of Year
2,456,384
521,192
Cash and Cash Equivalents, End of Period
3,796,586
1,538,931
3
Condensed Consolidated Balance Sheet
June 302008
December 312007
Assets
Current Assets:
Cash and cash equivalents
Investments, including $307,500 of investments measured at fair value at December 31, 2007
1,381,688
364,443
Trade receivables, less allowances of $276,637 in 2008 and $258,288 in 2007
5,189,052
4,946,876
Inventories:
Finished products
1,752,566
1,677,083
Work in process
790,956
681,634
Materials
617,682
592,725
Total inventories
3,161,204
2,951,442
Prepaid expenses, deferred income taxes, and other receivables
3,428,638
3,323,588
Total Current Assets
16,957,168
14,042,733
Investments
1,091,254
1,125,262
Property and Equipment, at Cost
16,299,707
15,597,801
Less: accumulated depreciation and amortization
8,507,823
8,079,652
Net Property and Equipment
7,791,884
7,518,149
Intangible Assets, net of amortization
6,009,853
5,720,478
Goodwill
10,791,052
10,128,841
Deferred Income Taxes and Other Assets
1,432,508
1,178,461
44,073,719
39,713,924
Liabilities and Shareholders Investment
Current Liabilities:
Short-term borrowings
3,706,123
1,827,361
Trade accounts payable
1,180,397
1,219,529
Salaries, dividends payable, and other accruals
5,252,853
5,077,428
Income taxes payable
156,177
80,406
Current portion of long-term debt
1,721,000
898,554
Total Current Liabilities
12,016,550
9,103,278
Long-term Debt
8,458,584
9,487,789
Post-employment Obligations and Other Long-term Liabilities
3,523,801
3,344,317
Long-term Obligations in Connection With Conclusion of TAP Pharmaceutical Products Inc. Joint Venture
1,115,982
Commitments and Contingencies
Shareholders Investment:
Preferred shares, one dollar par valueAuthorized 1,000,000 shares, none issued
Common shares, without par value Authorized - 2,400,000,000 sharesIssued at stated capital amount -Shares: 2008: 1,590,469,383; 2007: 1,580,854,677
6,745,205
6,104,102
Common shares held in treasury, at cost -Shares: 2008: 48,922,498; 2007: 30,944,537
(2,250,693
(1,213,134
Earnings employed in the business
11,963,641
10,805,809
Accumulated other comprehensive income (loss)
2,500,649
2,081,763
Total Shareholders Investment
18,958,802
17,778,540
4
Notes to Condensed Consolidated Financial Statements
June 30, 2008
Note 1 Basis of Presentation
The accompanying unaudited, condensed consolidated financial statements have been prepared pursuant to rules and regulations of the Securities and Exchange Commission and, therefore, do not include all information and footnote disclosures normally included in audited financial statements. However, in the opinion of management, all adjustments (which include only normal adjustments) necessary to present fairly the results of operations, financial position and cash flows have been made. It is suggested that these statements be read in conjunction with the financial statements included in Abbotts Annual Report on Form 10-K for the year ended December 31, 2007.
Abbotts core laboratory diagnostics business, including Point of Care, was accounted for as discontinued operations for the six months ended June 30, 2007. Subsequently, a decision was made to retain the businesses. The results for the six months ended June 30, 2007 included depreciation and amortization through January 17, 2007. The amount of depreciation and amortization not recorded in the first six months of 2007 was $99 million, which was recorded in the third quarter of 2007.
Note 2 Supplemental Financial Information
In connection with the dissolution of the TAP Pharmaceutical Products Inc. joint venture, Abbott recorded a gain of approximately $95 million in the second quarter 2008, which is included in Other (income) expense, net. Other (income) expense, net for the second quarter and six months ended June 30, 2008 also includes a gain of approximately $52 million on the sale of an equity investment accounted for as an available-for-sale investment. The remainder of Other (income) expense, net in 2008 relates primarily to contractual payments based on specified development, approval and commercial events being achieved with respect to products retained by TAP and payments from TAP based on sales of products retained by TAP.
Other (income) expense, net for the second quarter of 2007 includes a $48 million fair market value gain adjustment to Abbotts investment in Boston Scientific stock and a realized gain of $37 million on the sales of Boston Scientific stock. Other (income) expense, net for the first six months of 2007 includes a $101 million fair market value loss adjustment to Abbotts investment in Boston Scientific common stock and a realized gain of $37 million on the sales of Boston Scientific stock.
Supplemental Cash Flow Information In connection with the dissolution of the TAP Pharmaceutical Products Inc. joint venture, Abbott recorded intangible assets of approximately $700 million, goodwill of approximately $350 million, net deferred tax assets of approximately $160 million and a contingent liability of approximately $1.1 billion and derecognized its investment in the TAP Pharmaceutical Products Inc. joint venture of approximately $280 million in the second quarter of 2008. Other, net in Net cash from operating activities for 2008 and 2007 includes the effects of contributions to the main domestic defined benefit plan of $200 million in each period and to the post-employment medical and dental plans of $65 million and $75 million, respectively. (Purchases of) proceeds from sales of other investment securities, net in 2008 reflects the acquisition of short-term investments with original maturities of over three months.
Investments at June 30, 2008 and December 31, 2007 consist of the following:
(dollars in millions)
December 31
Current Investments:
Time deposits and certificates of deposit
1,382
57
Boston Scientific common stock
307
Total
364
Long-term Investments:
Equity securities
163
229
Note receivable from Boston Scientific, 4% interest, due in 2011
857
851
71
45
1,091
1,125
5
(Unaudited), continued
Note 3 Conclusion of TAP Pharmaceutical Products Inc. Joint Venture
On April 30, 2008, Abbott and Takeda concluded their TAP Pharmaceutical Products Inc. (TAP) joint venture, evenly splitting the value and assets of the joint venture. Abbott exchanged its 50 percent equity interest in TAP for the assets, liabilities and employees related to TAPs Lupron business. The Internal Revenue Service has issued a private letter ruling that the transaction qualifies as tax-free for U.S. income tax purposes.
Beginning on May 1, 2008, Abbott began recording U.S. Lupronnet sales and costs in its operating results and no longer records income from the TAP joint venture. TAPs sales of Lupron were $182 million for the four months ended April 30, 2008 and $645 million for the full year 2007. Abbott will also receive payments based on specified development, approval and commercial events being achieved with respect to products retained by TAP and payments from TAP based on sales of products retained by TAP, which are recorded by Abbott as Other (income) expense, net as earned. Such payments, which will be subject to tax, are expected to approximate $1.5 billion over a five-year period.
The exchange transaction was accounted for as a sale of Abbotts equity interest in TAP and as an acquisition of TAPs Lupronbusiness under SFAS No. 141 Business Combinations. The sale of Abbotts equity interest in TAP resulted in the recording of net assets of approximately $225 million related to the Lupron business, primarily cash, receivables, inventory and other assets, net of accounts payable and other accrued liabilities, offset by a credit to Abbotts investment in TAP in the amount of approximately $280 million.
For the acquired Lupron business, Abbott recorded intangible assets, primarily Lupronproduct rights, of approximately $700 million, goodwill of approximately $350 million and deferred tax liabilities related to the intangible assets of approximately $250 million. The intangible assets are being amortized over 15 years. Abbott has also agreed to remit cash to TAP if certain research and development events are not achieved on the development assets retained by TAP. These amounts were recorded as a liability at closing in the amount of approximately $1.1 billion. Related deferred tax assets of approximately $410 million were also recorded, resulting in an after-tax liability of approximately $700 million. If these payments are not required, the liability would be reduced and a gain would be recorded.
The exchange of Abbotts investment in TAP for TAPs Lupronbusiness resulted in a gain at closing of approximately $95 million, which is in addition to the amounts discussed in the second paragraph above. The valuation of the assets and liabilities is preliminary and is expected to be finalized in the third quarter.
The 50 percent-owned joint venture was accounted for under the equity method of accounting. Summarized financial information for TAP follows below (in millions). The results for 2008 include results through April 30.
Three Months Ended June 30
Six Months Ended June 30
Net sales
141
767
853
1,516
Cost of sales
46
188
368
Income before taxes
35
365
356
826
34
232
238
525
Note 4 Acquired In-process Research and Development
In the first half of 2008, technology investments and acquired product rights resulted in charges to acquired in-process research and development of approximately $97 million.
Note 5 Taxes on Earnings
Taxes on earnings reflect the estimated annual effective rates and include charges for interest and penalties. The effective tax rates are less than the statutory U.S. federal income tax rate principally due to the domestic dividend exclusion in 2007 and the benefit of lower statutory tax rates and tax exemptions in several taxing jurisdictions. In the second quarter of 2008, Abbotts federal income tax returns for 2004 and 2005 were settled, resulting in a net reduction of income taxes of approximately $30 million.
6
Note 6 Litigation and Environmental Matters
Abbott has been identified as a potentially responsible party for investigation and cleanup costs at a number of locations in the United States and Puerto Rico under federal and state remediation laws and is investigating potential contamination at a number of company-owned locations. Abbott has recorded an estimated cleanup cost for each site for which management believes Abbott has a probable loss exposure. No individual site cleanup exposure is expected to exceed $3 million, and the aggregate cleanup exposure is not expected to exceed $15 million.
There are a number of patent disputes with third parties who claim Abbotts products infringe their patents. In one of those disputes, filed in April 2007, Abbott is unable to estimate a range of possible loss, if any, and no reserve has been recorded. Abbotts acquisition of Kos Pharmaceuticals Inc. resulted in the assumption of various cases and investigations and Abbott has recorded reserves related to several of those cases and investigations.
There are several civil actions pending brought by individuals or entities that allege generally that Abbott and numerous pharmaceutical companies reported false or misleading pricing information relating to the average wholesale price of certain pharmaceutical products in connection with federal, state and private reimbursement. Civil actions have also been brought against Abbott, and in some cases other members of the pharmaceutical industry, by state attorneys general seeking to recover alleged damages on behalf of state Medicaid programs. In May 2006, Abbott was notified that the U.S. Department of Justice intervened in a civil whistle-blower lawsuit alleging that Abbott inflated prices for Medicaid and Medicare reimbursable drugs. Abbott has recorded reserves for its estimated losses in a few of the cases, however, Abbott is unable to estimate the range or amount of possible loss for the majority of the cases, and no loss reserves have been recorded for them. Many of the products involved in these cases are Hospira products. Hospira, Abbotts former hospital products business, was spun off to Abbotts shareholders in 2004. Abbott retained liability for losses that result from these cases and investigations to the extent any such losses both relate to the sale of Hospiras products prior to the spin-off of Hospira and relate to allegations that were made in such pending and future cases and investigations that were the same as allegations existing at the date of the spin-off.
There are several civil actions pending brought by state attorneys general and private entities alleging antitrust and unfair competition claims in connection with the sales of TriCor. Abbott licenses TriCor from a third party and the licensor has also been named as a defendant. There are several civil actions pending brought by private payers and others alleging antitrust claims in connection with the pricing of Norvir. Abbott is unable to estimate a range of loss, if any, and no loss reserves have been recorded.
Within the next year, legal proceedings may occur that may result in a change in the estimated reserves recorded by Abbott. For its legal proceedings and environmental exposures, except as noted above, Abbott estimates the range of possible loss to be from approximately $155 million to $345 million. The recorded reserve balance at June 30, 2008 for these proceedings and exposures was approximately $195 million. These reserves represent managements best estimate of probable loss, as defined by Statement of Financial Accounting Standards No. 5, Accounting for Contingencies.
While it is not feasible to predict the outcome of all such proceedings and exposures with certainty, management believes that their ultimate disposition should not have a material adverse effect on Abbotts financial position, cash flows, or results of operations, except for the cases and investigations discussed in the third paragraph and the patent case discussed in the second paragraph of this footnote, the resolution of which could be material to cash flows or results of operations for a quarter.
7
Note 7 Post-Employment Benefits
Retirement plans consist of defined benefit, defined contribution, and medical and dental plans. Net cost for the three and six months ended June 30 for Abbotts major defined benefit plans and post-employment medical and dental benefit plans is as follows:
Defined Benefit Plans
Medical and Dental Plans
Three Months
Six Months
Ended June 30
Service cost benefits earned during the period
55
61
115
121
11
15
23
30
Interest cost on projected benefit obligations
84
76
170
151
22
25
48
49
Expected return on plans assets
(120
(103
(239
(205
(8
(6
(16
(13
Net amortization
18
44
1
8
17
Net Cost
24
56
64
111
26
42
83
Abbott funds its domestic defined benefit plans according to IRS funding limitations. In the first quarters of 2008 and 2007, $200 was contributed to the main domestic defined benefit plan and $65 and $75, respectively, was contributed to the post-employment medical and dental benefit plans.
Note 8 Comprehensive Income, net of tax
Foreign currency translation gain adjustments
242
247
433
263
Unrealized (losses) gains on marketable equity securities
(2
(27
Amortization of net actuarial losses and prior service cost and credits
20
16
40
Net adjustments for derivative instruments designated as cash flow hedges
(15
(4
(9
Other comprehensive income, net of tax
246
418
295
1,322
989
2,260
1,686
Comprehensive Income
1,568
1,235
2,678
1,981
Supplemental Comprehensive Income Information, net of tax:
Cumulative foreign currency translation (gain) adjustments
(3,381
(2,059
Net actuarial losses and prior service cost and credits
899
1,217
Cumulative unrealized (gains) on marketable equity securities
(39
(14
Cumulative losses (gains) on derivative instruments designated as cash flow hedges
21
(12
Note 9 Segment Information
Abbotts principal business is the discovery, development, manufacture and sale of a broad line of health care products. Abbotts products are generally sold directly to retailers, wholesalers, hospitals, health care facilities, laboratories, physicians offices and government agencies throughout the world. Abbotts reportable segments are as follows:
Pharmaceutical Products Worldwide sales of a broad line of pharmaceuticals. For segment reporting purposes, two pharmaceutical divisions are aggregated and reported as the Pharmaceutical Products segment.
Nutritional Products Worldwide sales of a broad line of adult and pediatric nutritional products.
Diagnostic Products Worldwide sales of diagnostic systems and tests for blood banks, hospitals, commercial laboratories and alternate-care testing sites. For segment reporting purposes, three diagnostic divisions are aggregated and reported as the Diagnostic Products segment.
VascularProducts Worldwide sales of coronary, endovascular, vessel closure and other products.
Abbotts underlying accounting records are maintained on a legal entity basis for government and public reporting requirements. Segment disclosures are on a performance basis consistent with internal management reporting. Intersegment transfers of inventory are recorded at standard cost and are not a measure of segment operating earnings. The cost of some corporate functions and the cost of certain employee benefits are charged to segments at predetermined rates that approximate cost. Remaining costs, if any, are not allocated to segments. For acquisitions prior to 2006, substantially all intangible assets and related amortization are not allocated to segments. The following segment information has been prepared in accordance with the internal accounting policies of Abbott, as described above, and are not presented in accordance with generally accepted accounting principles applied to the consolidated financial statements.
Net Sales to External Customers
Operating Earnings (Loss)
Pharmaceuticals
4,123
3,532
7,978
6,904
1,541
1,330
2,886
2,493
Nutritionals (a)
1,097
2,344
2,099
193
376
410
Diagnostics
936
799
1,768
1,509
102
68
155
94
Vascular
489
423
941
844
47
(29
(52
Total Reportable Segments
6,783
5,851
13,031
11,356
1,883
1,598
3,433
2,945
531
520
1,049
960
7,314
6,371
14,080
12,316
Corporate functions and benefit plans costs
(97
(137
(210
(226
Non-reportable segments
41
114
113
178
Net interest expense
(83
(125
(176
(249
(79
Income from TAP Pharmaceutical Products Inc. joint venture
116
119
262
Share-based compensation (b)
(68
(87
(220
(250
Other, net (c)
(165
(567
Consolidated Earnings Before Taxes
1,636
1,253
2,797
2,093
(a) Operating earnings in 2008 for the Nutritional Products segment were impacted by higher commodity costs.
(b) Approximately 40 to 45 percent of the annual cost of share-based awards will typically be recognized in the first quarter due to the timing of the granting of share-based awards.
(c) Other, net for the three months and six months ended June 30, 2008, includes the gain from the closing of the TAP joint venture and contractual payments from TAP associated with the closing of the TAP Pharmaceutical Products Inc. joint venture. Other, net for the three months and six months ended June 30, 2007, includes acquisition integration expenses related to the acquisitions of Guidants vascular intervention and endovascular solutions businesses and Kos Pharmaceuticals Inc. and the reversal of depreciation on property and equipment classified as held for sale that was recorded by the Diagnostics segment.
9
Note 10 Incentive Stock Programs
In the first six months of 2008, Abbott granted 20,069,002 stock options, 1,797,028 replacement stock options, 809,650 restricted stock awards and 541,874 restricted stock units under this program. At June 30, 2008, approximately 28 million shares were reserved for future grants. Information regarding the number of options outstanding and exercisable at June 30, 2008 is as follows:
Outstanding
Exercisable
Number of shares
141,007,220
99,290,665
Weighted average remaining life (years)
6.7
5.7
Weighted average exercise price
48.66
46.94
Aggregate intrinsic value (in millions)
709
640
The total unrecognized share-based compensation cost at June 30, 2008 amounted to approximately $329 million which is expected to be recognized over the next three years.
Note 11 Goodwill and Intangible Assets
In connection with the dissolution of the TAP Pharmaceutical Products Inc. joint venture, Abbott recorded approximately $350 of goodwill. Foreign currency translation adjustments and other adjustments increased goodwill in the first six months of 2008 and 2007 by approximately $312 and $129, respectively. There were no reductions of goodwill relating to impairments or disposal of all or a portion of a business. The amount of goodwill related to reportable segments at June 30, 2008 was $6,806 for the Pharmaceutical Products segment, $206 for the Nutritional Products segment, $262 for the Diagnostic Products segment and $2,166 for the Vascular Products segment.
The gross amount of amortizable intangible assets, primarily product rights and technology was $9,713 as of June 30, 2008 and $9,043 as of December 31, 2007, and accumulated amortization was $3,703 as of June 30, 2008 and $3,323 as of December 31, 2007. The estimated annual amortization expense for intangible assets is approximately $775 in 2008, $785 in 2009 and approximately $770 in 2010, 2011 and 2012. Intangible assets are amortized over 4 to 25 years (average 11 years).
Note 12 Restructuring Plans
In 2007, 2006 and 2005, Abbott management approved plans to realign its worldwide pharmaceutical manufacturing operations and selected domestic and international commercial and research and development operations in order to reduce costs. Additional charges of $44 and $67 were subsequently recorded in the first six months of 2008 and 2007, respectively, relating to these restructurings, primarily for accelerated depreciation. In addition, Abbott implemented facilities restructuring plans in the second quarter of 2007 related to the acquired operations of Kos Pharmaceuticals Inc., which resulted in an increase to goodwill of approximately $52. The following summarizes the activity for restructurings:
Accrued balance at January 1
194
Restructuring charges
59
Payments and other adjustments
(59
(63
Accrued balance at June 30
146
189
10
Note 13 Fair Value Measures
The following table summarizes the bases used to measure certain assets and liabilities at fair value on a recurring basis in the balance sheet:
Basis of Fair Value Measurement
OutstandingBalances
QuotedPrices inActiveMarkets
SignificantOtherObservableInputs
SignificantUnobservableInputs
June 30, 2008:
Marketable available-for-sale securities
219
33
Foreign currency forward exchange contracts
Financial assets relating to TAP employees stock options
29
Total Assets
282
62
Fair value of hedged long-term debt
2,443
Interest rate swap financial instruments
Financial liabilities relating to TAP employees stock options
Total Liabilities
2,562
2,520
December 31, 2007:
Trading securities
308
501
1,475
1,545
In connection with the conclusion of the TAP Pharmaceutical Products Inc. joint venture, Abbott recorded derivative financial assets and liabilities related to stock options previously granted to TAPs employees. The amounts of these assets and liabilities were calculated using both the Black-Scholes optionpricing model and the intrinsic value of the options. From April 30, 2008 to June 30, 2008 both the assets and liabilities decreased by approximately $11 million. The effect of the changes in these assets and liabilities offset each other. In addition, Abbott received investments that are valued using significant unobservable inputs. The recorded value of these investments did not change significantly during the quarter.
FINANCIAL REVIEW
Results of Operations
The following table details sales by reportable segment for the three months and six months ended June 30. Percent changes are versus the prior year and are based on unrounded numbers.
PercentChange
Pharmaceutical Products
16.7
17.2
15.5
16.9
Nutritional Products
12.6
4.6
11.7
(4.2
Diagnostic Products
11.4
17.1
10.8
Vascular Products
15.7
63.3
11.6
146.6
15.9
16.1
14.8
2.2
12.2
9.1
8.8
15.8
14.3
15.3
Total U.S
3,410
3,225
17.7
6,452
4.8
6,158
13.8
Total International
3,904
24.1
3,146
13.9
7,628
23.9
16.8
Worldwide sales for the second quarter and six months 2008 compared to 2007 reflects unit growth and the positive effect of the relatively weaker U.S. dollar. The relatively weaker U.S. dollar increased second quarter 2008 consolidated net sales by 5.9 percent, Total International sales by 12.0 percent, Pharmaceutical Products segment sales by 6.0 percent, Diagnostic Products segment sales by 9.2 percent and Vascular Products segment sales by 6.4 percent over the second quarter of 2007. The relatively weaker U.S. dollar also increased the first six months 2008 consolidated net sales by 5.7 percent, Total International sales by 11.5 percent, Pharmaceutical Products segment sales by 6.0 percent, Diagnostic Products segment sales by 8.7 percent and Vascular Products segment sales by 5.6 percent over the first six months of 2007. The relatively weaker U.S. dollar increased second quarter 2007 consolidated net sales by 2.7 percent, Total International sales by 5.3 percent, Pharmaceutical Products segment sales by 2.7 percent, Diagnostic Products segment sales by 3.8 percent and Vascular Products segment sales by 2.2 percent over the second quarter of 2006. The relatively weaker U.S. dollar also increased the first six months 2007 consolidated net sales by 2.7 percent, Total International sales by 5.4 percent, Pharmaceutical Products segment sales by 2.7 percent, Diagnostic Products segment sales by 3.9 percent and Vascular Products segment sales by 2.3 percent over the first six months of 2006. Sales growth in 2007 for the Nutritional Products segment was unfavorably impacted by the completion of the co-promotion of Synagis in 2006.
12
(continued)
A comparison of significant product group sales for the six months ended June 30 is as follows. Percent changes are versus the prior year and are based on unrounded numbers.
Percent
Change
Pharmaceutical Products
U.S. Specialty
2,341
19.5
1,958
26.1
U.S. Primary Care
1,411
(8.1
1,535
38.9
International Pharmaceuticals
3,743
27.0
2,948
12.9
Nutritional Products
U.S. Pediatric Nutritionals
615
582
6.1
International Pediatric Nutritionals
634
22.9
516
18.6
U.S. Adult Nutritionals
562
3.3
544
(0.8
International Adult Nutritionals
18.9
437
12.3
Diagnostics
Immunochemistry
17.3
1,203
Increased sales of HUMIRA and Depakote and the addition of Lupron sales in 2008 accounted for the majority of the sales increases for U.S. Specialty products in both 2008 and 2007. U.S. sales of HUMIRA were $927 million, $696 million and $501 million for the six months ended June 30, 2008, 2007 and 2006, respectively. U.S. Primary Care sales in 2008 were impacted by a significant decrease in sales of Omnicefdue to generic competition, partially offset by increased sales of Niaspan and TriCor. U.S. Primary Care sales in 2007 were favorably impacted by sales of Niaspan, a new product from the acquisition of Kos Pharmaceuticals Inc. in the fourth quarter of 2006, and TriCor and were unfavorably impacted by decreased sales of Biaxin. Increased sales of HUMIRA favorably impacted International Pharmaceutical sales in both 2008 and 2007. International sales of HUMIRAwere $1.039 billion, $611 million and $382 million for the six months ended June 30, 2008, 2007 and 2006, respectively. International Pediatric Nutritionals sales increases in 2008 and 2007 were due primarily to volume growth in developing countries. The favorable effect of the relatively weaker U.S. dollar favorably impacted international product sales growth in both years.
The gross profit margin was 57.3 percent for the second quarter 2008, compared to 56.0 percent for the second quarter 2007. First six months 2008 gross profit margin was 56.8 percent, compared to 56.2 percent for the first six months 2007. The increases in the gross profit margins in 2008 were due primarily to favorable product and business mix.
Research and development expenses increased 12.6 percent in the second quarter 2008 and 6.2 percent for the first six months 2008 over comparable 2007 periods. These increases reflect increased spending to support pipeline programs, including oncology, immunology, hepatitis C, neuroscience and drug eluting stents. The majority of research and development expenditures is concentrated on pharmaceutical products.
Selling, general and administrative expenses for the second quarter and first six months 2008 increased 14.2 percent and 13.6 percent, respectively, over the comparable 2007 periods. These increases reflect increased selling and marketing support for new and existing products, including continued spending for HUMIRAand the U.S. launch of Xience V, as well as spending on other marketed pharmaceutical products.
13
Conclusion of TAP Pharmaceutical Products Inc. Joint Venture
Beginning on May 1, 2008, Abbott began recording U.S. Lupronnet sales and costs in its operating results and no longer records income from the TAP joint venture. TAPs sales of Lupron were $182 million for the four months ended April 30, 2008 and $645 million for the full year 2007. Abbott expects to record U.S. sales of Lupron of approximately $400 million in 2008. Abbott will also receive payments based on specified development, approval and commercial events being achieved with respect to products retained by TAP and payments from TAP based on sales of products retained by TAP, which are recorded by Abbott as Other (income) expense, net as earned. Such payments, which will be subject to tax, are expected to approximate $1.5 billion over a five-year period.
Restructurings
14
Basis of Presentation
Acquired In-process Research and Development
Interest (Income)
Interest income increased in the second quarter and first six months of 2008 over 2007 primarily as the result of higher investment balances.
Taxes on earnings reflect the estimated annual effective rates. The effective tax rates are less than the statutory U.S. federal income tax rate principally due to the domestic dividend exclusion in 2007 and the benefit of lower statutory tax rates and tax exemptions in several taxing jurisdictions. In the second quarter of 2008, Abbotts federal income tax returns for 2004 and 2005 were settled, resulting in a net reduction of income taxes of approximately $30 million.
Liquidity and Capital Resources at June 30, 2008 Compared with December 31, 2007
Net cash from operating activities for the first six months 2008 totaled approximately $3.1 billion. Abbott expects annual cash flow from operating activities to continue to exceed Abbotts capital expenditures and cash dividends. Subsequent to June 30, 2008, Abbott paid $250 million to Boston Scientific as a result of the FDAs approval to market the Xience Vdrug-eluting stent in the U.S. This payment will result in an increase in goodwill.
Working capital was $4.9 billion at June 30, 2008 and December 31, 2007.
For the acquired Lupron business, Abbott recorded intangible assets, primarily Lupronproduct rights, of approximately $700 million, goodwill of approximately $350 million and deferred tax liabilities related to the intangible assets of approximately $250 million. Abbott also recorded a liability of approximately $1.1 billion relating to an agreement to remit cash to TAP if certain research and development events are not achieved on the development assets retained by TAP. Related deferred tax assets of approximately $410 million were also recorded, resulting in an after-tax liability of approximately $700 million. If these payments are not required, the liability would be reduced and a gain would be recorded.
At June 30, 2008, Abbotts long-term debt rating was AA by Standard & Poors Corporation and A1 by Moodys Investors Service. Abbott has readily available financial resources, including unused lines of credit of $4.0 billion that support commercial paper borrowing arrangements.
In 2006, the board of directors authorized the purchase of $2.5 billion of Abbotts common shares from time to time. During the first six months of 2008 and 2007, Abbott purchased approximately 19.0 million and 15.4 million, respectively, of its common shares at a cost of approximately $1.1 billion and $827 million, respectively.
Under a registration statement filed with the Securities and Exchange Commission in February 2006, Abbott may offer and sell from time to time debt securities in one or more offerings through February 2009.
Legislative Issues
Abbotts primary markets are highly competitive and subject to substantial government regulation throughout the world. Abbott expects debate to continue over the availability, method of delivery, and payment for health care products and services. Abbott believes that if legislation is enacted, it could have the effect of reducing access to health care products and services, or reducing prices or the rate of price increases for health care products and services. It is not possible to predict the extent to which Abbott or the health care industry in general might be adversely affected by these factors in the future. A more complete discussion of these factors is contained in Item 1, Business, and Item 1A, Risk Factors on Form 10-K for the year ended December 31, 2007.
Private Securities Litigation Reform Act of 1995 A Caution Concerning Forward-Looking Statements
Under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Abbott cautions investors that any forward-looking statements or projections made by Abbott, including those made in this document, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Economic, competitive, governmental, technological and other factors that may affect Abbotts operations are discussed in Item 1A, Risk Factors to the Annual Report on Form 10-K for the year ended December 31, 2007.
Item 4. Controls and Procedures
(a) Evaluation of disclosure controls and procedures. The Chief Executive Officer, Miles D. White, and Chief Financial Officer, Thomas C. Freyman, evaluated the effectiveness of Abbott Laboratories disclosure controls and procedures as of the end of the period covered by this report, and concluded that Abbott Laboratories disclosure controls and procedures were effective to ensure that information Abbott is required to disclose in the reports that it files or submits with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (the Exchange Act) is recorded, processed, summarized and reported, within the time periods specified in the Commissions rules and forms, and to ensure that information required to be disclosed by Abbott in the reports that it files or submits under the Exchange Act is accumulated and communicated to Abbotts management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
(b) Changes in internal control over financial reporting. During the quarter ended June 30, 2008, there were no changes in Abbotts internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that have materially affected, or are reasonably likely to materially affect, Abbotts internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Abbott is involved in various claims, legal proceedings and investigations, including (as of June 30, 2008, except as otherwise indicated) those described below.
In April 2008, the case Patrick Warren Proffitt, et. al.was filed against Abbott in the Circuit Court for Cocke County, Tennessee alleging antitrust and consumer fraud claims in connection with the sale of fenofibrate formulations. The case has been brought as a purported class action on behalf of all Tennessee individuals who purchased Tricor® or a generic substitute during the period from 1998 through 2008. In May 2008, the case was removed to the United States District Court for the Eastern District of Tennessee.
In its 2007 Form 10-K, Abbott reported that a number of cases are pending that allege generally that Abbott and numerous other pharmaceutical companies reported false pricing information in connection with certain drugs that are reimbursable under Medicare and Medicaid and by private payors and that the federal cases have been consolidated in the United States District Court for the District of Massachusetts as In re: Pharmaceutical Industry Average Wholesale Price Litigation, MDL 1456. In June 2008, one of those consolidated cases, an action brought by the Utah Attorney General against Abbott and other manufacturers, was remanded to state court in Utah.
In its 2007 Form 10-K, Abbott reported that a purported derivative lawsuit was pending in the United States District Court for the Northern District of Illinois brought by Leonard Bronstein, an Abbott shareholder, on behalf of Abbott against Abbott and each member of its Board of Directors. In May 2008, the court dismissed this case.
In its 2007 Form 10-K, Abbott reported that litigation was pending in the United Kingdom in which Abbott was seeking a declaration that Abbotts original (as of 2006) and modified Multi-Link Vision® and Xience V coronary stent systems do not infringe Evysios three patents and that Evysios patents are invalid. Abbott also reported that Evysio had filed a counterclaim accusing Abbotts stents of infringement and seeking a declaration of validity. On April 21, 2008, the court in the United Kingdom issued a final judgment, not subject to appeal, holding that Abbotts modified design stents do not infringe any of the three Evysio patents, that two of the Evysio patents are invalid, and that Abbotts original design stents do not infringe Evysios only valid patent.
In its 2007 Form 10-K and Form 10-Q for the quarter ended March 31, 2008, Abbott reported that it had filed lawsuits against several companies seeking injunctive relief in connection with their proposed generic versions of extended release Depakote®. In the second quarter, Abbott entered into confidential settlement agreements resolving each of these cases, except for the cases filed against Banner Pharmacaps Inc. and Sun Pharmaceutical Industries Ltd. The remaining cases are not material to Abbott.
In June 2008, Abbott received a subpoena from the United States Department of Justice, through the United States Attorney for the District of Massachusetts. The government is investigating the sales and marketing activities of Abbotts biliary stent products. The government is seeking to determine whether any of these activities violated civil and/or criminal laws, including the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-Kickback Statute in connection with Medicare and/or Medicaid reimbursement paid to third parties.
While it is not feasible to predict with certainty the outcome of the pending claims, proceedings and investigations in which Abbott is involved, including those previously disclosed, management is of the opinion that their ultimate dispositions should not have a material adverse effect on Abbotts financial position, cash flows, or results of operations, except for the case filed in April 2007 referred to in the second paragraph of Note 6 to Abbotts financial statements above and the cases described in the third paragraph of such note.
19
Item 1A. Risk Factors
There have been no material changes in our risk factors from those disclosed in Abbotts 2007 Form 10-K, except for the following:
The manufacture of many of Abbotts products is a highly exacting and complex process, and if Abbott or one of its suppliers encounters problems manufacturing products, Abbotts business could suffer.
The manufacture of many of Abbotts products is a highly exacting and complex process, due in part to strict regulatory requirements. Problems may arise during manufacturing for a variety of reasons, including equipment malfunction, failure to follow specific protocols and procedures, problems with raw materials, natural disasters and environmental factors. In addition, single suppliers are currently used for certain products and materials. If problems arise during the production of a batch of product, that batch of product may have to be discarded. This could, among other things, lead to increased costs, lost revenue, damage to customer relations, time and expense spent investigating the cause and, depending on the cause, similar losses with respect to other batches or products. If problems are not discovered before the product is released to the market, recall and product liability costs may also be incurred. To the extent Abbott or one of its suppliers experiences significant manufacturing problems, this could have a material adverse effect on Abbotts revenues and profitability.
Other factors can have a material adverse effect on Abbotts future profitability and financial condition.
Many other factors can affect Abbotts profitability and its financial condition, including:
· Differences between the fair value measurement of assets and liabilities and their actual value, particularly for pensions, retiree health care, stock compensation, intangibles and goodwill; and for contingent liabilities such as litigation, the absence of a recorded amount, or an amount recorded at the minimum, compared to the actual amount.
· Changes in or interpretations of laws and regulations including changes in accounting standards, taxation requirements and environmental laws in domestic or foreign jurisdictions.
· Changes in the rate of inflation (including the cost of raw materials, commodities and supplies), interest rates, market value of Abbotts equity investments, and the performance of investments held by Abbott or Abbotts employee benefit trusts.
· Changes in business and political conditions, including (i) war, political instability, terrorist attacks in the U.S. and other parts of the world, the threat of future terrorist activity in the U.S. and other parts of the world and related military action, (ii) natural disasters, (iii) the cost and availability of insurance due to any of the foregoing events, (iv) labor disputes, strikes, slow-downs or other forms of labor or union activity, and (v) pressure from third-party interest groups.
· Changes in Abbotts business units and investments and changes in the relative and absolute contribution of each to earnings and cash flow resulting from evolving business strategies, changing product mix, changes in tax rates both in the U.S. and abroad and opportunities existing now or in the future.
· Changes in the buying patterns of a major distributor, retailer, or wholesale customer resulting from buyer purchasing decisions, pricing, seasonality, or other factors, or other problems with licensors, suppliers, distributors and business partners.
· Difficulties related to Abbotts information technology systems, any of which could adversely affect business operations, including any significant breakdown, invasion, destruction or interruption of these systems.
· In connection with Abbotts acquisition of the vascular intervention and endovascular solutions businesses of Guidant Corporation, Abbott loaned BSC International Holding, Limited (a wholly-owned subsidiary of Boston Scientific) $900 million on a subordinated basis. As long as the loan is outstanding, Abbott will be a creditor of Boston Scientific with respect to the $900 million loan and, as such, is subject to credit risk.
· Legal difficulties, any of which could preclude or delay commercialization of products or adversely affect profitability, including claims asserting statutory or regulatory violations, adverse litigation decisions, and issues regarding compliance with any governmental consent decree or corporate integrity agreement.
(c) Issuer Purchases of Equity Securities
Period
(a) TotalNumber ofShares (orUnits)Purchased
(b) AveragePrice Paid perShare (or Unit)
(c) Total Numberof Shares (orUnits) Purchasedas Part ofPubliclyAnnounced Plansor Programs
(d) MaximumNumber (orApproximateDollar Value) ofShares (or Units)that May Yet BePurchasedUnder the Plansor Programs
April 1, 2008 April 30, 2008
5,026,816
(1)
50.620
4,942,800
430,351,656
(2)
May 1, 2008 May 31, 2008
342,062
54.486
0
June 1, 2008 June 30, 2008
189,534
54.199
5,558,412
50.980
1. These shares include:
(i)
the shares deemed surrendered to Abbott to pay the exercise price in connection with the exercise of employee stock options 70,016 in April, 328,062 in May, and 175,534 in June; and
(ii)
the shares purchased on the open market for the benefit of participants in the Abbott Canada Stock Retirement Plan 14,000 in April, 14,000 in May, and 14,000 in June.
These shares do not include the shares surrendered to Abbott to satisfy tax withholding obligations in connection with the vesting of restricted stock or restricted stock units.
2. On October 18, 2006, Abbott announced that its board of directors approved the purchase of up to $2.5 billion of its common shares.
Item 4. Submission of Matters to a Vote of Security Holders
Abbott Laboratories held its Annual Meeting of Shareholders on April 25, 2008. The following is a summary of the matters voted on at that meeting.
Name
Votes For
Votes Withheld
Roxanne S. Austin
1,339,585,799
22,401,501
William M. Daley
1,336,548,642
25,438,658
W. James Farrell
1,333,126,336
28,860,964
H. Laurance Fuller
1,328,698,246
33,289,054
William A. Osborn
1,327,779,120
34,208,180
The Rt. Hon. Lord Owen CH
1,330,196,285
31,791,015
Boone Powell Jr.
1,328,263,922
33,723,378
W. Ann Reynolds, Ph.D.
1,324,076,547
37,910,753
Roy S. Roberts
1,338,960,890
23,026,410
Samuel C. Scott III
1,275,653,145
86,334,155
William D. Smithburg
1,264,060,988
97,926,312
Glenn F. Tilton
1,335,624,305
26,362,995
Miles D. White
1,329,172,835
32,814,465
(b) The shareholders ratified the appointment of Deloitte & Touche LLP as Abbotts auditors. The number of shares cast in favor of the ratification of Deloitte & Touche LLP, the number against, and the number abstaining were as follows:
For
Against
Abstain
1,346,517,731
3,480,415
11,989,154
(c) The shareholders rejected a shareholder proposal on access to medicines. The number of shares cast in favor of the shareholder proposal, the number against, the number abstaining, and the number of broker non-votes were as follows:
Broker Non-Vote
43,283,767
979,028,778
177,639,726
162,035,029
(d) The shareholders rejected a shareholder proposal on advisory vote. The number of shares cast in favor of the shareholder proposal, the number against, the number abstaining, and the number of broker non-votes were as follows:
429,308,494
729,675,093
40,969,494
162,034,219
Item 6. Exhibits
Incorporated by reference to the Exhibit Index included herewith.
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 thereunto duly authorized.
By:
/s/ Thomas C. Freyman
Thomas C. Freyman,
Executive Vice President,
Finance and Chief Financial Officer
Date:
July 25, 2008
EXHIBIT INDEX
Exhibit No.
Exhibit
Statement re: computation of ratio of earnings to fixed charges.
31.1
Certification of Chief Executive Officer Required by Rule 13a-14(a) (17 CFR 240.13a-14(a)).
31.2
Certification of Chief Financial Officer Required by Rule 13a-14(a) (17 CFR 240.13a-14(a)).
Exhibits 32.1 and 32.2 are furnished herewith and should not be deemed to be filed under the Securities Exchange Act of 1934.
32.1
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.