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8-K - 8-K - ST JUDE MEDICAL, LLCa16-15166_18k.htm

Exhibit 99.1

 

 

 

St. Jude Medical, Inc.

 

Global Headquarters

 

One St. Jude Medical Drive

 

St. Paul, MN 55117-9913 USA

 

Tel   651 756 2000

 

sjm.com

 

News Release

 

MEDIA CONTACT:

INVESTOR CONTACT:

Candace Steele Flippin

J.C. Weigelt

csflippin@sjm.com

jweigelt@sjm.com

Tel 651 756 3029

Tel 651 756 4347

 

St. Jude Medical Reports Second Quarter 2016 Results

 

ST. PAUL, Minn. — July 20, 2016 — St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today reported sales and net earnings for the second quarter ended July 2, 2016.

 

Second quarter 2016 highlights:

 

·                  Net sales of $1.562 billion increased 11 percent as reported, or 2 percent on a comparable constant currency basis.

·                  International sales increased 10 percent as reported, or 7 percent on a comparable constant currency basis where a full portfolio of products is available.

·                  Neuromodulation sales increased 19 percent as reported, or 20 percent on a constant currency basis driven by the most comprehensive product portfolio on the market.

·                  Atrial fibrillation sales increased 13 percent as reported and on a constant currency basis driven by strong growth across the product portfolio.

·                  Diluted earnings per share of $0.83 decreased 19 percent as reported. Adjusted earnings per share of $1.06 increased 7 percent on a constant currency basis.

·                  Announced a definitive agreement on April 28 to be acquired by Abbott under which St. Jude Medical shareholders will receive $46.75 in cash and 0.8708 shares of Abbott common stock per share.

 

Second Quarter 2016 Sales

 

The company reported net sales of $1.562 billion in the second quarter of 2016, an 11 percent increase compared to net sales of $1.410 billion in the second quarter of 2015. On a comparable constant currency basis, net sales increased by approximately 2 percent compared to the second quarter of 2015.

 

Commenting on the company’s financial results, St. Jude Medical President and Chief Executive Officer Michael T. Rousseau said, “We continued to build momentum during the second quarter by bringing innovative products to our global markets. The strong performance in international sales gives us confidence that where we have a full portfolio, we can deliver top-tier growth. One of the major highlights of our quarter was the announcement of our pending merger with Abbott. We continue to be confident and excited about the potential of our combined organization and the powerful impact we can have on delivering industry leading innovation to physicians and patients around the world.”

 

As previously announced, St. Jude Medical has changed its sales reporting to more closely align with how the company manages the business in five key areas: atrial fibrillation, heart failure, neuromodulation, cardiovascular and traditional cardiac rhythm management. For additional information please see the Form 8-K provided by the company on January 13, 2016.

 



 

 

Atrial Fibrillation (AF)

 

AF product sales for the second quarter totaled $324 million, a 13 percent increase both on a reported and constant currency basis compared to the prior year quarter. Second quarter results were driven by strong global TactiCath™ and FlexAbility™ ablation catheter sales.

 

Heart Failure (HF)

 

HF product sales, which include cardiac resynchronization therapy (CRT) products, HeartMate™ ventricular assist devices and the CardioMEMS™ HF System, totaled $384 million for the second quarter, a 48 percent increase compared to the prior year quarter, primarily due to incremental net sales associated with ventricular assist devices, acquired through our Thoratec acquisition. On a comparable constant currency basis, HF product sales decreased 1 percent compared to the prior year quarter. Second quarter results reflect strong global growth in ventricular assist devices, offset by the impact of U.S. CRM sales weakness on our CRT products.

 

Neuromodulation

 

St. Jude Medical sales of neuromodulation products were $140 million in the second quarter of 2016, a 19 percent increase on a reported basis and a 20 percent increase on a constant currency basis compared to the prior year quarter. Neuromodulation growth was driven by the St. Jude Medical Burst technology offering in international markets, U.S. launch of the Axium™ system as well as the introduction of the Infinity™ DBS system and directional lead in Europe.

 

Cardiovascular

 

Total cardiovascular sales were $319 million for the second quarter of 2016, an increase of 1 percent compared to the prior year quarter. On a constant currency basis, cardiovascular sales increased 2 percent compared to the prior year quarter. Cardiovascular growth was driven by the continued strength of the Portico™ Transcatheter Aortic Valve Implantation System in Europe and our PCI optimization strategy, which includes products such as OPTIS™ optical coherence tomography products and PressureWire™ fractional flow reserve technology.

 

Traditional Cardiac Rhythm Management (CRM)

 

Total CRM sales, which include single and dual chamber implantable cardioverter defibrillator (ICD) and pacemaker products, were $395 million for the second quarter of 2016, an 8 percent decline compared with the second quarter of 2015. After adjusting for the impact of foreign currency, traditional CRM sales decreased 7 percent. Global results continue to be impacted by lower sales in the United States, partially offset by continued adoption of our MRI conditional product portfolio in countries where they are offered.

 

Second Quarter Earnings Results

 

In the second quarter the company recognized net after-tax charges of $67 million, or $0.23 per diluted share, primarily related to amortization of intangible assets and acquisition-related costs. Including these items, reported net earnings for the second quarter of 2016 were $238 million or $0.83 per share, compared with reported net earnings for the second quarter of 2015 of $290 million or $1.02 per share. Excluding these items, adjusted net earnings for the second quarter of 2016 were $305 million or $1.06 per share, compared with adjusted net earnings for the second quarter of 2015 of $293 million or $1.03

 



 

 

per share. A reconciliation of the company’s non-GAAP adjusted results to the company’s GAAP reported results is provided in the schedules at the end of the press release.

 

Third Quarter and Full-Year 2016 Sales and Earnings Guidance

 

Due to the planned merger with Abbott, St. Jude Medical is withdrawing financial guidance for the fiscal year 2016.

 

Conference Call / Webcast

 

St. Jude Medical’s second quarter earnings call can be heard live via webcast today beginning at 7 a.m. CDT via the St. Jude Medical Investor Relations website (investors.sjm.com). Approximately one hour following the call (and archived for 90 days), a replay will be available on the Investor Events and Presentations webpage in the Investor Relations section of the St. Jude Medical website.

 

St. Jude Medical will also be tweeting live during the call on our Investor Relations Twitter account, @StJudeMedicalIR.

 

About St. Jude Medical

 

St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has five major areas of focus that include atrial fibrillation, heart failure, neuromodulation, cardiovascular and traditional cardiac rhythm management. For more information, please visit sjm.com or follow us on Twitter @StJudeMedicalIR.

 

Forward-Looking Statements

 

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company’s control and the risk factors and other cautionary statements described in the company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

 



 

 

Summary of 2Q16 Sales and Reconciliation to Constant Currency Sales Growth

(in millions)

(unaudited)

 

 

2Q16 Sales

2Q15 Sales

Reported %
Change vs.
2Q15

Constant
Currency %
Change vs.
2Q15

Reported
$ Change
vs. 2Q15

Constant
Currency
$ Change
vs. 2Q15

Foreign
Currency
Impact

Total Sales

$1,562

$1,410

11%

11%

$152

$158

-$6

Total International Sales

$767

$697

10%

11%

 

 

 

Total U.S. Sales

$795

$713

12%

 

Worldwide Atrial Fibrillation

$324

$286

13%

13%

$38

$37

$1

International Atrial Fibrillation

$189

$166

14%

13%

 

 

 

U.S. Atrial Fibrillation

$135

$120

13%

 

Worldwide Heart Failure

$384

$260

48%

48%

$124

$125

-$1

International Heart Failure

$128

$89

44%

45%

 

 

 

U.S. Heart Failure

$256

$171

49%

 

Worldwide Neuromodulation

$140

$118

19%

20%

$22

$23

-$1

International Neuromodulation

$43

$36

19%

22%

 

 

 

U.S. Neuromodulation

$97

$82

19%

 

Worldwide Cardiovascular Disease

$319

$316

1%

2%

$3

$4

-$1

International Cardiovascular Disease

$198

$194

2%

3%

 

 

 

U.S. Cardiovascular Disease

$121

$122

-1%

 

Worldwide Traditional Cardiac Rhythm Management

$395

$430

-8%

-7%

-$35

-$31

-$4

International Traditional Cardiac Rhythm Management

$209

$212

-2%

0%

 

 

 

U.S. Traditional Cardiac Rhythm Management

$186

$218

-15%

 

 

Note: Percentage changes are based on actual, non-rounded amounts and may not recalculate precisely.

 



 

 

Summary of 2Q16 Sales and Reconciliation to Comparable Constant Currency Sales Growth

(in millions)

(unaudited)

 

 

2Q16
Sales

2Q15
Comparable
Sales

Comparable
Constant
Currency %
Change vs.
2Q15

Comparable
Constant
Currency $
Change vs.
2Q15

Foreign
Currency
Impact

Total Sales

$1,562

$1,539

2%

$29

-$6

Total International Sales

$767

$722

7%

 

 

Total U.S. Sales

$795

$817

-3%

Worldwide Atrial Fibrillation

$324

$286

13%

$37

$1

International Atrial Fibrillation

$189

$166

13%

 

 

U.S. Atrial Fibrillation

$135

$120

13%

Worldwide Heart Failure

$384

$389

-1%

-$4

-$1

International Heart Failure

$128

$114

14%

 

 

U.S. Heart Failure

$256

$275

-7%

Worldwide Neuromodulation

$140

$118

20%

$23

-$1

International Neuromodulation

$43

$36

22%

 

 

U.S. Neuromodulation

$97

$82

19%

Worldwide Cardiovascular Disease

$319

$316

2%

$4

-$1

International Cardiovascular Disease

$198

$194

3%

 

 

U.S. Cardiovascular Disease

$121

$122

-1%

Worldwide Traditional Cardiac Rhythm Management

$395

$430

-7%

-$31

-$4

International Traditional Cardiac Rhythm Management

$209

$212

0%

 

 

U.S. Traditional Cardiac Rhythm Management

$186

$218

-15%

 

 

 

 

 

 

Total Thoratec Pre-Acquisition Sales

$0

$129

 

 

 

International Thoratec Pre-Acquisition Sales

$0

$25

 

 

 

U.S. Thoratec Pre-Acquisition Sales

$0

$104

 

 

 

 

 

 

 

 

Total Sales As Reported

$1,562

$1,410

11%

$158

-$6

Total International Sales As Reported

$767

$697

11%

 

 

Total U.S. Sales As Reported

$795

$713

 

 

Note: Dollar amounts and percentage changes are based on actual, non-rounded amounts and may not add or recalculate precisely.

 



 

 

St. Jude Medical, Inc.

Condensed Consolidated Balance Sheets

(in millions)

(Unaudited)

 

 

 

July 2, 2016

 

January 2, 2016

 

Cash and cash equivalents

 

$398

 

$667

 

Accounts receivable, net

 

1,330

 

1,237

 

Inventories

 

904

 

909

 

Other current assets

 

295

 

269

 

Property, plant & equipment, net

 

1,326

 

1,320

 

Goodwill

 

5,670

 

5,651

 

Intangible assets, net

 

2,146

 

2,226

 

Other assets

 

589

 

621

 

Total assets

 

$12,658

 

$12,900

 

 

 

 

 

 

 

Current debt obligations

 

$660

 

$1,163

 

Other current liabilities

 

1,053

 

1,303

 

Long-term debt

 

5,431

 

5,229

 

Long-term other liabilities

 

1,233

 

1,163

 

Total shareholders’ equity

 

4,281

 

4,042

 

Total liabilities & shareholders’ equity

 

$12,658

 

$12,900

 

 

St. Jude Medical, Inc.

Condensed Consolidated Statements of Earnings

(in millions, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

July 2, 2016

 

July 4, 2015

 

July 2, 2016

 

July 4, 2015

 

Net sales

 

$1,562

 

$1,410

 

$3,010

 

$2,755

 

Cost of sales:

 

 

 

 

 

 

 

 

 

Cost of sales before special charges

 

490

 

419

 

974

 

812

 

Special charges

 

6

 

5

 

9

 

7

 

Total cost of sales

 

496

 

424

 

983

 

819

 

Gross profit

 

1,066

 

986

 

2,027

 

1,936

 

 

 

 

 

 

 

 

 

 

 

Selling, general & administrative expense

 

502

 

447

 

993

 

877

 

Research & development expense

 

192

 

171

 

380

 

338

 

Amortization of intangible assets

 

46

 

24

 

92

 

48

 

Special charges

 

13

 

30

 

21

 

34

 

Operating profit

 

313

 

314

 

541

 

639

 

Other expense, net

 

43

 

20

 

135

 

37

 

Earnings before income taxes and noncontrolling interest

 

270

 

294

 

406

 

602

 

Income taxes

 

32

 

12

 

73

 

64

 

Net earnings before noncontrolling interest

 

238

 

282

 

333

 

538

 

Net loss attributable to noncontrolling interest

 

 

(8

)

 

(14

)

Net earnings attributable to St. Jude Medical, Inc.

 

$238

 

$290

 

$333

 

$552

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net earnings per share attributable to St. Jude Medical, Inc.

 

$0.83

 

$1.02

 

$1.16

 

$1.93

 

Adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. (Non-GAAP) (1)

 

$1.06

 

$1.03

 

$1.96

 

$1.95

 

 

 

 

 

 

 

 

 

 

 

Cash dividends declared per share

 

$0.31

 

$0.29

 

$0.62

 

$0.58

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding- diluted

 

288.3

 

285.5

 

287.3

 

286.3

 

 


(1)  See accompanying reconciliation tables.

 



 

 

Non-GAAP Financial Measures Reconciliations (Unaudited)

 

 

 

Three Months Ended July 2, 2016

 

(in millions, except per share amounts)

 

Earnings before
noncontrolling
interest and income
taxes

 

Income taxes

 

Effective tax rate

 

Net earnings before
noncontrolling
interest

 

Net loss attributable
to noncontrolling
interest

 

Net earnings
attributable to St.
Jude Medical, Inc.

 

Diluted net earnings
per share attributable
to St. Jude Medical,
Inc.

 

Diluted EPS growth
rate

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As reported (GAAP)

 

$

270

 

$

32

 

11.9

%

$

238

 

$

 

$

238

 

$

0.83

 

-19

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Restructuring activities

 

15

 

5

 

 

 

10

 

 

10

 

0.03

 

 

 

Acquisition-related costs

 

25

 

6

 

 

 

19

 

 

19

 

0.07

 

 

 

Product field action costs and litigation costs

 

6

 

2

 

 

 

4

 

 

4

 

0.01

 

 

 

Legal settlements

 

(2

)

(1

)

 

 

(1

)

 

(1

)

(0.00

)

 

 

Amortization of intangible assets

 

46

 

16

 

 

 

30

 

 

30

 

0.10

 

 

 

Income tax adjustments

 

 

(5

)

 

 

5

 

 

5

 

0.02

 

 

 

As adjusted (Non-GAAP)

 

$

360

 

$

55

 

15.3

%

$

305

 

$

 

$

305

 

$

1.06

 

3

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unfavorable foreign currency impact vs. 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

0.04

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Constant currency as adjusted (non-GAAP)

 

 

 

 

 

 

 

 

 

 

 

 

 

$

1.10

 

7

%

 

 

 

Restructuring
activities

 

Acquisition-related
costs

 

Product field action
costs and litigation
costs

 

Legal settlements

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales before special charges

 

$

 

$

10

 

$

 

$

 

$

10

 

Special charges (cost of sales)

 

3

 

 

3

 

 

6

 

Selling, general & administrative expense

 

 

15

 

 

 

15

 

Special charges (operating expenses)

 

12

 

 

3

 

(2

)

13

 

 

 

$

15

 

$

25

 

$

6

 

$

(2

)

$

44

 

 

 

 

Three Months Ended July 4, 2015

 

 

 

(in millions, except per share amounts)

 

Earnings before
noncontrolling
interest and income
taxes

 

Income taxes

 

Effective tax rate

 

Net earnings before
noncontrolling
interest

 

Net loss attributable
to noncontrolling
interest

 

Net earnings
attributable to St.
Jude Medical, Inc.

 

Diluted net earnings
per share attributable
to St. Jude Medical,
Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As reported (GAAP)

 

$

294

 

$

12

 

4.1

%

$

282

 

$

(8

)

$

290

 

$

1.02

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Restructuring activities

 

36

 

11

 

 

 

25

 

 

25

 

0.09

 

 

 

Acquisition-related costs

 

(10

)

1

 

 

 

(11

)

4

 

(15

)

(0.05

)

 

 

Product field action costs and litigation costs

 

(1

)

 

 

 

(1

)

 

(1

)

0.00

 

 

 

Amortization of intangible assets

 

24

 

7

 

 

 

17

 

 

17

 

0.06

 

 

 

Income tax adjustments

 

 

29

 

 

 

(29

)

 

(29

)

(0.10

)

 

 

R&D credit

 

 

(6

)

 

 

6

 

 

6

 

0.02

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As adjusted (Non-GAAP)

 

$

343

 

$

54

 

15.7

%

$

289

 

$

(4

)

$

293

 

$

1.03

 

 

 

 

 

 

Restructuring
activities

 

Acquisition-related
costs

 

Product field action
costs and litigation
costs

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Special charges (cost of sales)

 

$

9

 

$

 

$

(4

)

$

5

 

 

 

Selling, general & administrative expense

 

 

(11

)

 

(11

)

 

 

Research & development expense

 

 

1

 

 

1

 

 

 

Special charges (operating expenses)

 

27

 

 

3

 

30

 

 

 

 

 

$

36

 

$

(10

)

$

(1

)

$

25

 

 

 

 



 

 

 

 

Six Months Ended July 2, 2016

 

(in millions, except per share amounts)

 

Earnings before
noncontrolling
interest and income
taxes

 

Income taxes

 

Effective tax rate

 

Net earnings before
noncontrolling
interest

 

Net loss attributable
to noncontrolling
interest

 

Net earnings
attributable to St.
Jude Medical, Inc.

 

Diluted net earnings
per share attributable
to St. Jude Medical,
Inc.

 

Diluted EPS growth
rate

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As reported (GAAP)

 

$

406

 

$

73

 

18.0

%

$

333

 

$

 

$

333

 

$

1.16

 

-40

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Restructuring activities

 

40

 

14

 

 

 

26

 

 

26

 

0.09

 

 

 

Acquisition-related costs

 

89

 

26

 

 

 

63

 

 

63

 

0.22

 

 

 

Product field action costs and litigation costs

 

9

 

3

 

 

 

6

 

 

6

 

0.02

 

 

 

Legal settlements

 

(19

)

(6

)

 

 

(13

)

 

(13

)

(0.05

)

 

 

Strategic investment impairments

 

51

 

19

 

 

 

32

 

 

32

 

0.11

 

 

 

Amortization of intangible assets

 

92

 

32

 

 

 

60

 

 

60

 

0.21

 

 

 

Income tax adjustments

 

 

(57

)

 

 

57

 

 

57

 

0.20

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As adjusted (Non-GAAP)

 

$

668

 

$

104

 

15.6

%

$

564

 

$

 

$

564

 

$

1.96

 

1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unfavorable foreign currency impact vs. 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

0.15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Constant currency as adjusted (non-GAAP)

 

 

 

 

 

 

 

 

 

 

 

 

 

$

2.11

 

8

%

 

 

 

Restructuring
activities

 

Acquisition-related
costs

 

Product field action
costs and litigation
costs

 

Legal settlements

 

Strategic investment
impairments

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales before special charges

 

$

 

$

41

 

$

 

$

 

$

 

$

41

 

Special charges (cost of sales)

 

6

 

 

3

 

 

 

9

 

Selling, general & administrative expense

 

 

48

 

 

 

 

48

 

Special charges (operating expenses)

 

34

 

 

6

 

(19

)

 

21

 

Other expense, net

 

 

 

 

 

 

51

 

51

 

 

 

$

40

 

$

89

 

$

9

 

$

(19

)

$

51

 

$

170

 

 

 

 

Six Months Ended July 4, 2015

 

 

 

(in millions, except per share amounts)

 

Earnings before
noncontrolling
interest and income
taxes

 

Income taxes

 

Effective tax rate

 

Net earnings before
noncontrolling
interest

 

Net loss attributable
to noncontrolling
interest

 

Net earnings
attributable to St.
Jude Medical, Inc.

 

Diluted net earnings
per share attributable
to St. Jude Medical,
Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As reported (GAAP)

 

$

602

 

$

64

 

10.6

%

$

538

 

$

(14

)

$

552

 

$

1.93

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Restructuring activities

 

49

 

14

 

 

 

35

 

 

35

 

0.12

 

 

 

Acquisition-related costs

 

(32

)

2

 

 

 

(34

)

4

 

(38

)

(0.13

)

 

 

Product field action costs and litigation costs

 

2

 

1

 

 

 

1

 

 

1

 

0.00

 

 

 

Legal settlements

 

(10

)

(4

)

 

 

(6

)

 

(6

)

(0.02

)

 

 

Amortization of intangible assets

 

48

 

15

 

 

 

33

 

 

33

 

0.12

 

 

 

Income tax adjustments

 

 

29

 

 

 

(29

)

 

(29

)

(0.10

)

 

 

R&D credit

 

 

(11

)

 

 

11

 

 

11

 

0.04

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As adjusted (Non-GAAP)

 

$

659

 

$

110

 

16.7

%

$

549

 

$

(10

)

$

559

 

$

1.95

 

 

 

 

 

 

Restructuring
activities

 

Acquisition-related
costs

 

Product field action
costs and litigation
costs

 

Legal settlements

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Special charges (cost of sales)

 

$

13

 

$

 

$

(6

)

$

 

$

7

 

 

 

Selling, general & administrative expense

 

 

(33

)

 

 

(33

)

 

 

Research & development expense

 

 

1

 

 

 

1

 

 

 

Special charges (operating expenses)

 

36

 

 

8

 

(10

)

34

 

 

 

 

 

$

49

 

$

(32

)

$

2

 

$

(10

)

$

9

 

 

 

 

The sum of the components may not equal the total due to rounding and quantities of shares outstanding in different periods.

 

Tax rates vary and are applied based on the item’s nature and tax jurisdiction where it is incurred.

 

Non-GAAP Financial Measures

 

The company provides the following non-GAAP financial measures that St. Jude Medical management believes are pertinent to ongoing business performance. St. Jude Medical management uses these non-GAAP financial measures to forecast and evaluate the operational performance of the company as well as to compare results of current periods to prior periods on a consolidated basis.

 

·                  Adjusted earnings before noncontrolling interest and income taxes

·                  Adjusted income taxes and adjusted effective tax rate

·                  Adjusted net earnings before noncontrolling interest

·                  Adjusted net loss attributable to noncontrolling interest

·                  Adjusted net earnings attributable to St. Jude Medical, Inc.

 



 

 

·                  Adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. and adjusted diluted EPS growth rate

·                  Adjusted constant currency diluted net earnings per share attributable to St. Jude Medical, Inc. and adjusted constant currency diluted EPS growth rate

 

The adjustments made to GAAP financial measures result from facts and circumstances that vary in frequency and impact on the company’s results of operations. The following is an explanation of each of the adjustments that management excludes in calculating its non-GAAP measures.

 

Restructuring activities — These amounts represent severance costs and other termination benefits, inventory write-offs primarily associated with discontinued product lines, fixed asset write-offs related to assets no longer expected to be utilized, other restructuring costs and restructuring-related costs.

 

Acquisition-related costs — These amounts consist of contingent consideration fair value adjustments, acquired inventory step-up amortization, other transaction costs, integration costs, financing commitment fees and stock-based compensation expense for accelerated and replacement equity awards.

 

Product field action costs and litigation costs — These amounts primarily relate to inventory write-off and disposal costs, additional warranty and patient monitoring costs, and estimated legal costs for outstanding legal matters associated with product field actions.

 

Legal settlements — These amounts consist of losses that are probable and reasonably estimable, gains related to favorable resolutions of litigation matters and probable insurance recoveries.

 

Strategic investment impairments — These amounts consist of other-than-temporary impairments of certain strategic investments in debt and equity securities.

 

Amortization of intangible assets — These amounts represent the non-cash amortization expenses St. Jude Medical recognized for definite-lived intangible assets.

 

Income tax adjustments — These amounts represent tax effects related to significant unusual or infrequent items not attributable to current-year ordinary income, such as settlement of tax positions and discrete tax adjustments to uncertain tax positions, and certain other tax adjustments.

 

R&D credit — These amounts represent the impact of the federal research and development tax credit to present comparative periods assuming that the tax credit had been applicable in all periods presented.

 

Foreign currency impact — These amounts represent the impact to net sales and adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. after translating net sales and the consolidated statement of earnings at comparable prior period foreign currency exchange rates.

 

The company provides comparable constant currency sales growth because St. Jude Medical management believes that in order to understand the company’s short-term and long-term financial trends, investors may wish to consider the impact of the Thoratec acquisition and foreign currency translation on net sales. St. Jude Medical management uses comparable constant currency sales growth to forecast and evaluate the operational performance of the company as well as to compare sales of current periods to prior periods.

 



 

 

In calculating comparable constant currency sales growth in its non-GAAP measures, the company a) excludes the impact to net sales after translating net sales at prior period foreign currency exchange rates and b) includes Thoratec sales amounts for periods prior to St. Jude Medical’s acquisition of Thoratec. Comparable constant currency sales amounts have not been adjusted to eliminate historical product sales between St. Jude Medical and Thoratec because management believes that such adjustments are not material.

 

The company also provides constant currency sales growth and constant currency adjusted EPS growth because St. Jude Medical management believes that in order to understand the company’s short-term and long-term financial trends, investors may wish to consider the impact of foreign currency translation on net sales and adjusted EPS. St. Jude Medical management uses constant currency sales growth and constant currency adjusted EPS growth to forecast and evaluate the operational performance of the company as well as to compare sales and adjusted EPS of current periods to prior periods.

 

Non-GAAP financial measures used by the company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. Investors should consider non-GAAP measures in addition to, and not as a substitute for, or superior to, financial performance measures prepared in accordance with GAAP.