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| STJ > SEC Filings for STJ > Form 10-Q on 12-Aug-2009 | All Recent SEC Filings |
12-Aug-2009
Quarterly Report
OVERVIEW
Our business is focused on the development, manufacture and distribution of
cardiovascular medical devices for the global cardiac rhythm management,
cardiovascular and atrial fibrillation therapy areas and implantable
neurostimulation devices for the management of chronic pain and neurological
disorders. We sell our products in more than 100 countries around the world. Our
largest geographic markets are the United States, Europe, Japan and Asia
Pacific. Our four operating segments are Cardiac Rhythm Management (CRM),
Cardiovascular (CV), Atrial Fibrillation (AF) and Neuromodulation (NMD). Each
operating segment focuses on developing and manufacturing products for its
respective therapy area. Our principal products in each operating segment are as
follows: CRM - tachycardia implantable cardioverter defibrillator systems (ICDs)
and bradycardia pacemaker systems (pacemakers); CV - vascular closure devices,
heart valve replacement and repair products and pressure measurement guidewires;
AF - electrophysiology introducers and catheters, advanced cardiac mapping and
navigation systems and ablation systems; and NMD - neurostimulation devices.
References to "St. Jude Medical," "St. Jude," "the Company," "we," "us" and
"our" are to St. Jude Medical, Inc. and its subsidiaries.
Our industry has undergone significant consolidation in the last decade and is
highly competitive. Our strategy requires significant investment in research and
development in order to introduce new products. We are focused on improving our
operating margins through a variety of techniques, including the production of
high quality products, the development of leading edge technology, the
enhancement of our existing products and continuous improvement of our
manufacturing processes. We expect cost containment pressure on healthcare
systems as well as competitive pressures in the industry will continue to place
downward pressure on prices for our products.
We participate in several different medical device markets, each of which has
its own expected growth rate. A significant portion of our net sales relate to
CRM devices - ICDs and pacemakers. Management remains focused on increasing our
worldwide CRM market share, as we are one of three principal manufacturers and
suppliers in the global CRM market. In order to help accomplish this objective,
we have continued to expand our selling organizations and introduce new CRM
products. We are also investing in our other three major growth platforms -
atrial fibrillation, neuromodulation and cardiovascular - to increase our market
share.
Net sales in the second quarter and first six months of 2009 were
$1,184.4 million and $2,318.2 million, respectively, an increase of 4% and 8%
over the second quarter and first six months of 2008, respectively, led by sales
volume growth of our ICDs and pacemakers as well as products to treat atrial
fibrillation. Unfavorable foreign currency translation comparisons decreased our
2009 net sales in the second quarter and first six months by $68.9 million and
$119.8 million, respectively. Our ICD and pacemaker net sales both declined
approximately 1% in the second quarter of 2009, and grew nearly 4% and 2%,
respectively, during the first six months of 2009. Foreign currency translation
unfavorably impacted ICD and pacemaker net sales by $22.4 million and $19.2
million, respectively, in the second quarter of 2009, and $40.0 million and
$32.4 million, respectively, during the first six months of 2009. AF net sales
increased approximately 16% and 19% during the second quarter and first six
months of 2009, respectively, to $156.4 million and $301.6 million,
respectively. Unfavorable foreign currency translation comparisons decreased our
2009 AF net sales during the second quarter and first six months by
$10.2 million and $16.4 million, respectively. Refer to the Segment Performance
section below for a more detailed discussion of the results for the respective
segments.
Net earnings and diluted net earnings per share for the second quarter of 2009
were $219.4 million and $0.63 per diluted share, increases of 14% and 15%,
respectively, compared to the same prior year period. Net earnings and diluted
net earnings per share for the first six months of 2009 were $420.6 million and
$1.20 per diluted share, increases of 14% and 13%, respectively, over the first
six months of 2008. These increases for both the second quarter and first six
months of 2009 compared to the same prior year periods were primarily driven by
incremental profits resulting from higher sales volumes, led by our CRM and AF
operating segments. During the first quarter of 2009, we adopted a new
accounting standard, which required us to retrospectively adjust our historical
2008 financial statements. The adoption of this new accounting standard
decreased our 2008 net income and diluted earnings per share for the three and
six months ended June 28, 2008 by $8.1 million and $0.03 per share, and
$16.4 million and $0.04 per share, respectively. Refer to Note 3 of the
Condensed Consolidated Financial Statements in this Quarterly Report on Form
10-Q for further discussion of the new accounting standard.
We generated $358.5 million of operating cash flows during the first six months
of 2009, compared to $380.3 million of operating cash flows during the first six
months of 2008. We ended the second quarter with $486.6 million of cash and cash
equivalents and $1,285.5 million of total debt. As of August 12, 2009, we had
strong short-term credit ratings of A1 from Standard & Poor's, P2 from Moody's
and F1 from Fitch; additionally, our long-term credit rating included an A
rating from Standard & Poor's, a Baa1 rating from Moody's and an A rating from
Fitch.
NEW ACCOUNTING PRONOUNCEMENTS
Information regarding new accounting pronouncements is included in Note 2 to the
Condensed Consolidated Financial Statements in this Quarterly Report on Form
10-Q.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
We have adopted various accounting policies in preparing the consolidated
financial statements in accordance with accounting principles generally accepted
in the United States. Our significant accounting policies are disclosed in Note
1 to the Consolidated Financial Statements included in our Annual Report on Form
10-K for the fiscal year ended January 3, 2009 (2008 Annual Report on Form
10-K).
Preparation of our consolidated financial statements in conformity with
accounting principles generally accepted in the United States requires us to
adopt various accounting policies and to make estimates and assumptions that
affect the reported amounts in the financial statements and accompanying notes.
On an ongoing basis, we evaluate our estimates and assumptions, including those
related to accounts receivable allowance for doubtful accounts; estimated useful
lives of diagnostic equipment; valuation of purchased in-process research and
development, other intangible assets and goodwill; income taxes; legal reserves
and insurance receivables; and stock-based compensation. We base our estimates
on historical experience and various other assumptions that are believed to be
reasonable under the circumstances, and the results form the basis for making
judgments about the reported values of assets, liabilities, revenues and
expenses. Actual results may differ from these estimates. There have been no
material changes to our critical accounting policies and estimates from the
information provided in Part II, Item 7, Management's Discussion and Analysis of
Financial Condition and Results of Operations included in our 2008 Annual Report
on Form 10-K.
SEGMENT PERFORMANCE
Our four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular
(CV), Atrial Fibrillation (AF) and Neuromodulation (NMD). The primary products
produced by each operating segment are: CRM - ICDs and pacemakers; CV - vascular
closure devices, heart valve replacement and repair products and pressure
measurement guidewires; AF - electrophysiology introducers and catheters,
advanced cardiac mapping and navigation systems and ablation systems; and NMD -
neurostimulation devices.
We aggregate our four operating segments into two reportable segments based upon their similar operational and economic characteristics: CRM/NMD and CV/AF. Net sales of our reportable segments include end-customer revenues from the sale of products they each develop and manufacture. The costs included in each of the reportable segments' operating results include the direct costs of the products sold to end-customers and operating expenses managed by each reportable segment. Certain operating expenses managed by our selling and corporate functions, including all stock-based compensation expense, are not included in our reportable segments' operating profit. As a result, reportable segment operating profit is not representative of the operating profit of the products in these reportable segments.
The following table presents net sales and operating profit by reportable segment (in thousands):
CRM/NMD CV/AF Other Total
Three Months ended July 4, 2009:
Net sales $ 784,913 $ 399,499 $ - $ 1,184,412
Operating profit 486,024 211,987 (393,364 ) 304,647
Three Months ended June 28, 2008:
Net sales $ 772,404 $ 363,356 $ - $ 1,135,760
Operating profit 479,399 194,379 (380,425 ) 293,353
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Six Months ended July 4, 2009: Net sales $ 1,533,681 $ 784,524 $ - $ 2,318,205 Operating profit 947,054 402,872 (763,007 ) 586,919 Six Months ended June 28, 2008: Net sales $ 1,455,716 $ 690,782 $ - $ 2,146,498 Operating profit 899,673 368,297 (715,117 ) 552,853 |
The following discussion of the changes in our net sales is provided by class of
similar products within our four operating segments, which is the primary focus
of our sales activities.
Cardiac Rhythm Management
Three Months Ended Six Months Ended
July 4, June 28, % July 4, June 28, %
(in thousands) 2009 2008 Change 2009 2008 Change
ICD systems $ 400,477 $ 405,777 (1.3 )% $ 794,430 $ 766,729 3.6 %
Pacemaker systems 303,759 306,008 (0.7 )% 586,127 576,845 1.6 %
$ 704,236 $ 711,785 (1.1 )% $ 1,380,557 $ 1,343,574 2.8 %
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Cardiac Rhythm Management net sales were flat in the second quarter of 2009
compared to the second quarter of 2008 and increased 3% in the first six months
of 2009 over the same period one year ago. CRM net sales for both the second
quarter and first six months of 2009 were driven by sales volume growth;
however, unfavorable foreign currency translation comparisons decreased net
sales by $41.6 million and $72.4 million during the second quarter and first six
months of 2009, respectively, compared to the same periods in 2008.
ICD net sales were flat in the second quarter of 2009 compared to the second
quarter of 2008 and increased 4% in the first six months of 2009 compared to the
same period in 2008. Net sales growth was driven by volume growth across both
U.S. and international markets during the first six months of 2009, and our
international markets during the second quarter of 2009. In the United States,
second quarter 2009 ICD net sales of $255.2 million were flat over last year's
second quarter. Internationally, second quarter 2009 ICD net sales of
$145.3 million decreased 5% compared to the second quarter of 2008, due to the
impact of unfavorable foreign currency translation of $22.4 million. In the
United States, the first six months of 2009 ICD net sales of $512.8 million
increased 5% over the same period last year. Internationally, the first six
months of 2009 ICD net sales of $281.6 million remained relatively flat compared
to the first six months of 2008. Foreign currency translation had a
$40.0 million unfavorable impact on international ICD net sales during the first
six months of 2009 compared to the same period in 2008.
Pacemaker net sales remained flat in the second quarter of 2009 compared to the
second quarter of 2008 and increased approximately 2% in the first six months of
2009 compared to the same period in 2008, due to volume growth. In the second
quarter of 2009, pacemaker net sales in both the United States ($132.0 million)
and internationally ($171.8 million) were flat compared to the same prior year
period. Foreign currency translation had a $19.2 million unfavorable impact on
international pacemaker net sales in the second quarter of 2009 compared to the
same period last year. In the United States, the first six months of 2009
pacemaker net sales of $261.0 million increased 2% compared to the same period
last year. Internationally, the first six months of 2009 pacemaker net sales of
$325.1 million were flat compared to the first half of 2008.
Foreign currency translation had a $32.4 million unfavorable impact on
international pacemaker net sales during the first six months of 2009 compared
to the same period last year.
Cardiovascular
Three Months Ended Six Months Ended
July 4, June 28, % July 4, June 28, %
(in thousands) 2009 2008 Change 2009 2008 Change
Vascular closure
devices $ 98,884 $ 96,956 2.0 % $ 196,461 $ 187,043 5.0 %
Heart valve products 83,782 87,205 (3.9 )% 164,406 164,843 (0.3 )%
Other cardiovascular
products 60,463 43,814 38.0 % 122,049 84,622 44.2 %
$ 243,129 $ 227,975 6.6 % $ 482,916 $ 436,508 10.6 %
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Cardiovascular net sales increased approximately 7% and 11% during the second
quarter and first six months of 2009, respectively, compared to the same periods
in 2008. CV net sales were driven by volume growth but were unfavorably impacted
by foreign currency translation impacts of $14.8 million and $26.7 million
during the second quarter and first six months of 2009, respectively, compared
to the same periods last year.
Vascular closure device net sales increased 2% and 5% during the second quarter
and first six months of 2009, respectively, compared to the same periods last
year primarily driven by Angio-Seal™ volume growth and incremental sales
resulting from our acquisition of Radi Medical Systems AB in December 2008. Our
Angio-Seal™ device continues to be the market share leader in the vascular
closure device market. Heart valve net sales decreased 4% during the second
quarter of 2009 and were flat during the first six months of 2009 compared to
the same periods last year due to unfavorable foreign currency translation fully
offsetting increased sales volumes. Net sales of other cardiovascular products
increased $16.6 million and $37.4 million during the second quarter and first
six months of 2009, respectively, compared to the same periods last year due to
incremental sales of pressure measurement guidewires, a product line acquired
from Radi Medical System AB in December 2008, and increased sales volumes of
other cardiovascular products.
Atrial Fibrillation
Three Months Ended Six Months Ended
July 4, June 28, % July 4, June 28, %
(in thousands) 2009 2008 Change 2009 2008 Change
Atrial fibrillation
products $ 156,370 $ 135,381 15.5 % $ 301,608 $ 254,274 18.6 %
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Atrial Fibrillation net sales increased approximately 16% and 19% during the second quarter and first six months of 2009, respectively, compared to the same periods last year. The increases in AF net sales were driven by volume growth from continued market acceptance of device-based ablation procedures to treat the symptoms of atrial fibrillation and our expanded product offerings. Our access, diagnosis, visualization and ablation products assist physicians in diagnosing and treating atrial fibrillation and other irregular heart rhythms. Foreign currency translation had an unfavorable impact on AF net sales of $10.2 million and $16.4 million during the second quarter and first six months of 2009, respectively, compared to the same periods in 2008.
Neuromodulation
Three Months Ended Six Months Ended
July 4, June 28, % July 4, June 28, %
(in thousands) 2009 2008 Change 2009 2008 Change
Neurostimulation devices $ 80,677 $ 60,619 33.1 % $ 153,124 $ 112,142 36.5 %
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Neuromodulation net sales increased 33% and 37% during the second quarter and first six months of 2009, respectively, compared to the same prior year periods. The increases in NMD net sales were driven by strong volume growth and continued growth in the neuromodulation market. Foreign currency translation had an unfavorable impact on NMD net sales of $2.3 million and $4.3 million during the second quarter and first six months of 2009, respectively, compared to the same periods in 2008.
RESULTS OF OPERATIONS
Net Sales
Three Months Ended Six Months Ended
July 4, June 28, % July 4, June 28, %
(in thousands) 2009 2008 Change 2009 2008 Change
Net sales $ 1,184,412 $ 1,135,760 4.3 % $ 2,318,205 $ 2,146,498 8.0 %
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Overall, net sales increased 4% and 8% in the second quarter and first six months of 2009, respectively, compared to the same prior year periods. Net sales growth was favorably impacted by strong volume growth, driven primarily by our CRM and AF product sales. Foreign currency translation had an unfavorable impact on net sales for the second quarter and first six months of 2009 of $68.9 million and $119.8 million, respectively, due primarily to the strengthening of the U.S. Dollar against the Euro. These amounts are not indicative of the net earnings impact of foreign currency translation for the second quarter and first six months of 2009 due to partially offsetting foreign currency translation impacts on cost of sales and operating expenses. Net sales by geographic location of the customer were as follows (in thousands):
Three Months Ended Six Months Ended
July 4, June 28, July 4, June 28,
Net Sales 2009 2008 2009 2008
United States $ 630,658 $ 582,548 $ 1,250,999 $ 1,120,010
International
Europe 299,552 316,733 584,320 586,878
Japan 118,756 99,485 230,908 185,289
Asia Pacific 65,027 63,153 118,601 116,193
Other (a) 70,419 73,841 133,377 138,128
553,754 553,212 1,067,206 1,026,488
$ 1,184,412 $ 1,135,760 $ 2,318,205 $ 2,146,498
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(a) No one geographic market is greater than 5% of consolidated net sales.
Gross Profit
Three Months Ended Six Months Ended
July 4, June 28, July 4, June 28,
(in thousands) 2009 2008 2009 2008
Gross profit $ 878,868 $ 848,069 $ 1,718,166 $ 1,598,320
Percentage of net sales 74.2 % 74.7 % 74.1 % 74.5 %
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Gross profit for the second quarter of 2009 totaled $878.9 million, or 74.2% of net sales, compared to $848.1 million, or 74.7% of net sales, for the second quarter of 2008. Gross profit for the first six months of 2009 totaled $1,718.2 million, or 74.1% of net sales, compared to $1,598.3 million, or 74.5% of net sales, for the first six months of 2008. The decrease in our gross profit percentage for both the second quarter and first six months of 2009 compared to the same periods in 2008 resulted from unfavorable foreign currency translation impacts partially offset by sales mix and productivity improvements. Selling, General and Administrative (SG&A) Expense
Three Months Ended Six Months Ended
July 4, June 28, July 4, June 28,
(in thousands) 2009 2008 2009 2008
Selling, general and administrative $ 431,169 $ 416,261 $ 848,844 $ 783,377
Percentage of net sales 36.4 % 36.7 % 36.6 % 36.5 %
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SG&A expense for the second quarter of 2009 totaled $431.2 million, or 36.4% of net sales, compared to $416.3 million, or 36.7% of net sales, for the second quarter of 2008. SG&A expense for the first six months of 2009 totaled $848.8 million, or 36.6% of net sales, compared to $783.4 million, or 36.5% of net sales, for the first six months of 2008. Overall, SG&A expense as a percentage of net sales has remained relatively flat year over year.
Research and Development (R&D) Expense
Three Months Ended Six Months Ended
July 4, June 28, July 4, June 28,
(in thousands) 2009 2008 2009 2008
Research and development expense $ 143,052 $ 138,455 $ 282,403 $ 262,090
Percentage of net sales 12.1 % 12.2 % 12.2 % 12.2 %
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R&D expense in the second quarter of 2009 totaled $143.1 million, or 12.1% of net sales, compared to $138.5 million, or 12.2% of net sales, for the second quarter of 2008. R&D expense in the first six months of 2009 totaled $282.4 million, or 12.2% of net sales, compared to $262.1 million, or 12.2% of net sales, for the first six months of 2008. While 2009 R&D expense as a percent of net sales was flat compared to 2008, total R&D expense increased 3% and 8% for the second quarter and first six months of 2009, respectively, compared to the same periods in 2008. These increases reflect our continuing commitment to fund future long-term growth opportunities. We continue to balance delivering short-term results with our investments in long-term growth drivers.
Other Income (Expense), net
Three Months Ended Six Months Ended
June 28, June 28,
July 4, 2008 July 4, 2008
2009 (As adjusted) 2009 (As adjusted)
Interest income $ 518 $ 3,091 $ 1,077 $ 7,347
Interest expense (5,619 ) (18,101 ) (12,570 ) (36,126 )
Other 140 (3,010 ) (780 ) 332
Total other income (expense), net $ (4,961 ) $ (18,020 ) $ (12,273 ) $ (28,447 )
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The Company's 2009 adoption of Financial Accounting Standards Board (FASB) Staff Position (FSP) Accounting Principles Board (APB) Opinion No. 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (FSP APB No. 14-1) required retrospective application to all prior periods presented (see Note 3 to the Condensed Consolidated Financial Statements). As a result, non-cash interest expense adjustments of $13.0 million and $26.0 million were recorded in the second quarter and first six months of 2008, respectively, increasing 2008 interest expense to conform to the new accounting treatment.
Income Taxes
Three Months Ended Six Months Ended
June 28, June 28,
July 4, 2008 July 4, 2008
(as a percent of pre-tax income) 2009 (As adjusted) 2009 (As adjusted)
Effective tax rate 26.8 % 29.9 % 26.8 % 29.5 %
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Our effective income tax rate was 26.8% and 29.9% for the second quarter of 2009 and 2008, respectively, and 26.8% and 29.5% for the first six months of 2009 and 2008, respectively. The effective tax rate for the first six months of 2008 was unfavorably impacted by 2.1 percentage points due to the expiration of the Federal Research and Development tax credit (R&D tax credit) at the end of 2007, which was not signed into law until October 2008. The R&D tax credit was made retroactively effective for all of 2008 through 2009. Accordingly, no 2008 benefit from the R&D tax credit was recognized until October 2008. The impact of retrospectively applying the change in accounting for our convertible debentures (see Note 3 to the Condensed Consolidated Financial Statements) decreased the previously reported second quarter 2008 effective tax rate from 30.3% to 29.9% and first six months of 2008 effective tax rate from 29.9% to 29.5%.
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