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8-K - 8-K - ST JUDE MEDICAL, LLCa14-22439_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:

Micki Sievwright

J.C. Weigelt

msievwright@sjm.com

jweigelt@sjm.com

Tel 651 756 4615

Tel 651 756 4347

 

St. Jude Medical Reports Third Quarter 2014 Results

 

ST. PAUL, Minn. – October 15, 2014 – St. Jude Medical, Inc. (NYSE: STJ) today reported sales and net earnings for the third quarter ended September 27, 2014.

 

Third quarter highlights:

·                  Net sales increased 3 percent and adjusted net earnings per share increased 8 percent compared with the third quarter in 2013

·                  The CardioMEMS™ HF System received approval from the Center for Medicare and Medicaid Services for New Technology Add-On Payment, helping to ensure that Medicare patients have access to this innovative monitoring technology

·                  With the completion of its acquisition of NeuroTherm, Inc., the company is now the only medical device manufacturer with a chronic pain product portfolio that offers both radiofrequency ablation and spinal cord stimulation

 

Third Quarter 2014 Sales

 

The company reported net sales of $1.372 billion in the third quarter of 2014, an increase of approximately 3 percent on a reported basis over net sales of $1.338 billion in the third quarter of 2013. Foreign currency translations were not significant to overall sales results in the quarter.

 

Commenting on the company’s financial results, St. Jude Medical Chairman, President and Chief Executive Officer Daniel J. Starks said, “During the third quarter, sales growth accelerated in the U.S. due to the strength of our innovation and new products such as our CardioMEMS heart failure monitoring system. However, sales growth in our international markets was slower than expected and we have adjusted our outlook for the fourth quarter accordingly. We remain firmly committed to delivering an innovation-based growth program that adds significant value to the health care system by improving patient care while reducing costs.”

 

Cardiac Rhythm Management (CRM)

 

Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $688 million for the third quarter of 2014, a 1 percent increase compared with the third quarter of 2013.

 

Of that total, ICD product sales were $422 million in the third quarter, a 1 percent increase compared with the third quarter of 2013.

 

Third quarter pacemaker sales were $266 million, a 1 percent increase compared with the third quarter of 2013.

 



 

 

 

Atrial Fibrillation (AF)

 

AF product sales for the third quarter totaled $253 million, an 8 percent increase over the third quarter of 2013.

 

Cardiovascular

 

Total Cardiovascular sales, which primarily include vascular and structural heart products, were $324 million for the third quarter of 2014, a 2 percent increase compared to the third quarter of 2013.

 

Total structural heart product sales for the third quarter of 2014 were $155 million, a 4 percent increase compared with the third quarter of 2013.

 

Sales of vascular products in the third quarter of 2014 were $169 million, a 1 percent increase over the third quarter of 2013.

 

Neuromodulation

 

Neuromodulation product sales were $107 million in the third quarter of 2014, a 3 percent increase compared with the third quarter of 2013.

 

Third Quarter Earnings Results

 

In the third quarter, the company recognized net after-tax charges of $39 million, or $0.14 per share, primarily related to product field actions, impairment charges and restructuring activities. Including these items, reported net earnings for the third quarter of 2014 were $238 million or $0.82 per share, compared with reported net earnings for the third quarter of 2013 of $262 million or $0.90 per share.

 

In accordance with GAAP, reported net earnings for the third quarter 2014 do not include any benefit from the research and development tax credit, which has yet to be extended for 2014. Including the benefit of this adjustment and excluding the third quarter charges, adjusted net earnings for the third quarter of 2014 were $281 million, or $0.97 per share, an 8 percent increase compared with adjusted net earnings for the third quarter of 2013 of $0.90 per share. A reconciliation of the company’s non-GAAP adjusted net earnings per share to the company’s GAAP net earnings per share is provided in the schedules at the end of the press release.

 

Fourth Quarter and Full-Year 2014 Sales and Earnings Guidance

 

For the fourth quarter, St. Jude Medical expects revenue to be in the range of $1.385 billion to $1.465 billion. For the full-year 2014, the company now expects total revenue to be in the range of $5.568 billion to $5.648 billion. During a conference call today, St. Jude Medical will provide its range for revenue expectations for the fourth quarter and full-year 2014 by product category.

 

The company expects its consolidated adjusted net earnings for the fourth quarter of 2014 to be in the range of $1.02 to $1.04 per share and for full-year 2014 consolidated adjusted net earnings to now be in the range of $3.97 to $3.99. A further reconciliation of the company’s quarterly and annual guidance is provided in the schedules below.

 



 

 

 

Non-GAAP Financial Measures

 

The company provides adjusted net earnings and adjusted net earnings per share because St. Jude Medical management believes that in order to properly understand the company’s short-term and long-term financial trends, investors may wish to consider the impact of certain adjustments (such as acquisition-related costs, restructuring charges, impairment charges, litigation charges & settlements or litigation reserve adjustments and income tax adjustments). These adjustments result from facts and circumstances (such as acquisitions, business development activities, restructuring activities, asset impairment events or developments, settlements and other developments relating to litigation, discrete income tax adjustments and resolution of audits by tax authorities) that vary in frequency and impact on the company’s results of operations. St. Jude Medical management uses adjusted net earnings and adjusted net earnings per share 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.

 

The company provides constant-currency sales growth and constant-currency adjusted net earnings per share growth because St. Jude Medical management believes that in order to properly 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 net earnings. St. Jude Medical management uses constant-currency growth measurements to forecast and evaluate the operational performance of the company as well as to compare results of current periods to prior periods.

 

To measure net sales growth in constant currency, the current period net sales are translated at the comparable prior period foreign currency exchange rates. To measure adjusted net earnings per share growth in constant currency, the current period adjusted net earnings per share is translated at the comparable prior period foreign currency exchange rates.

 

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.

 

Conference Call/Webcast

 

St. Jude Medical’s third quarter earnings call can be heard live via webcast today beginning at 7 a.m. CDT (also archived for 90 days) on the Investor Relations section of our website, investors.sjm.com.

 

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 global medical device manufacturer 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 four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

 



 

 

 

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, 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 December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

 

 

 

 

 

St. Jude Medical, Inc.

Condensed Consolidated Balance Sheets

(in millions)

(Unaudited)

 

 

 

September 27, 2014

 

December 28, 2013

 

Cash and cash equivalents

 

$1,294

 

$1,373

 

Accounts receivable, net

 

1,334

 

1,422

 

Inventories

 

813

 

708

 

Other current assets

 

385

 

407

 

Property, plant & equipment, net

 

1,360

 

1,410

 

Goodwill

 

3,577

 

3,524

 

Other intangible assets, net

 

906

 

911

 

Other assets

 

567

 

493

 

Total assets

 

$10,236

 

$10,248

 

 

 

 

 

 

 

Current debt obligations

 

$810

 

$62

 

Other current liabilities

 

1,178

 

1,318

 

Long-term debt

 

3,054

 

3,518

 

Deferred income taxes, net

 

263

 

240

 

Long-term other liabilities

 

786

 

706

 

Total equity

 

4,145

 

4,404

 

Total liabilities & equity

 

$10,236

 

$10,248

 

 



 

 

 

Summary of Third Quarter 2014 Sales and Reconciliation to Constant Currency Sales Growth

(in millions)

 

 

 

 

 

 

(unaudited)

3Q14 Sales

 

 

3Q13 Sales

 

 

Reported %
Change vs.
3Q13

Constant
Currency %
Change vs.
3Q13

Reported
$ Change
vs. 3Q13

Constant
Currency $
Change
vs. 3Q13

Total Sales

$1,372

$1,338

3%

2%

$34

$33

Total International Sales

$706

$692

2%

2%

 

 

Total U.S. Sales

$666

$646

3%

 

 

 

Worldwide Cardiac Rhythm Management

$688

$682

1%

1%

$6

$5

International Cardiac Rhythm Management

$315

$322

-2%

-2%

 

 

U.S. Cardiac Rhythm Management

$373

$360

4%

 

 

 

Worldwide ICD

$422

$418

1%

1%

$4

$3

International ICD

$160

$165

-3%

-4%

 

 

U.S. ICD

$262

$253

4%

 

 

 

Worldwide Pacemakers

$266

$264

1%

1%

$2

$2

International Pacemakers

$155

$157

-1%

-1%

 

 

U.S. Pacemakers

$111

$107

4%

 

 

 

Worldwide Atrial Fibrillation

$253

$235

8%

8%

$18

$18

International Atrial Fibrillation

$155

$139

12%

12%

 

 

U.S. Atrial Fibrillation

$98

$96

2%

 

 

 

Worldwide Cardiovascular

$324

$317

2%

2%

$7

$7

International Cardiovascular

$204

$203

0%

0%

 

 

U.S. Cardiovascular

$120

$114

5%

 

 

 

Worldwide Neuromodulation

$107

$104

3%

3%

$3

$3

International Neuromodulation

$32

$28

14%

14%

 

 

U.S. Neuromodulation

$75

$76

-1%

 

 

 

 



 

 

 

St. Jude Medical, Inc.

Condensed Consolidated Statements of Earnings

(in millions, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

 

 

 

 

 

 

 

 

 

 

September 27, 2014

 

September 28, 2013

 

September 27, 2014

 

September 28, 2013

 

Net sales

 

$1,372

 

$1,338

 

$4,183

 

$4,079

 

Cost of sales:

 

 

 

 

 

 

 

 

 

Cost of sales before special charges

 

388

 

383

 

1,177

 

1,123

 

Special charges

 

24

 

2

 

51

 

21

 

Total cost of sales

 

412

 

385

 

1,228

 

1,144

 

Gross profit

 

960

 

953

 

2,955

 

2,935

 

 

 

 

 

 

 

 

 

 

 

Selling, general & administrative expense

 

476

 

452

 

1,464

 

1,409

 

Research & development expense

 

169

 

172

 

517

 

505

 

Special charges

 

45

 

16

 

103

 

118

 

Operating profit

 

270

 

313

 

871

 

903

 

Other expense, net

 

20

 

17

 

61

 

248

 

Earnings before noncontrolling interest and income taxes

 

250

 

296

 

810

 

655

 

Income tax expense (benefit)

 

18

 

44

 

93

 

74

 

Net earnings before noncontrolling interest

 

232

 

252

 

717

 

581

 

Net loss attributable to noncontrolling interest

 

(6)

 

(10)

 

(40)

 

(19)

 

Net earnings attributable to St. Jude Medical, Inc.

 

$238

 

$262

 

$757

 

$600

 

 

 

 

 

 

 

 

 

 

 

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

 

$281

(1)

$262

(2)

$854

(3)

$800

(4)

 

 

 

 

 

 

 

 

 

 

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

 

$0.82

 

$0.90

 

$2.62

 

$2.08

 

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

 

$0.97

(1)

$0.90

(2)

$2.95

(3)

$2.77

(4)

 

 

 

 

 

 

 

 

 

 

Cash dividends declared per share

 

$0.27

 

$0.25

 

$0.81

 

$0.75

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding- diluted

 

290.0

 

292.0

 

289.4

 

288.7

 

 

(1)  Third quarter 2014 adjusted net earnings attributable to St. Jude Medical, Inc. and adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. exclude the following after-tax items totaling $39 or $0.14 per share:

- $12 charges, or $0.04 per share, primarily related to restructuring activities. The associated pre-tax amount of $16 was recorded as a Special Charge to Cost of sales ($1) and Special charges ($15).

- $13 charges, or $0.04 per share, of acquisition-related costs primarily related to contingent consideration fair value adjustments, acquired inventory step-up amortization expense and other transaction costs.

The associated pre-tax amount of $15 was recorded to Cost of sales before special charges ($2) and Selling, general & administrative expense ($13).

- $22 charges, or $0.08 per share, related to product field action costs and litigation costs. The associated pre-tax amount of $28 was recorded as a Special charge to Cost of sales ($23) and Special charges ($5).

- $16 charges, or $0.06 per share, related to intangible asset impairment charges. The associated pre-tax amount of $25 was recorded to Special charges.

- $24 income tax benefit, or $0.08 per share, related to discrete income tax adjustments.

Third quarter 2014 adjusted net earnings attributable to St. Jude Medical, Inc. and adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. include $4 of income tax benefit, or $0.01 per share, for the third quarter expected benefit from the federal research and development tax credit not yet extended for 2014.

 

(2)  Third quarter 2013 adjusted net earnings attributable to St. Jude Medical, Inc. and adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. exclude after-tax charges of $15 million, or $0.05 per share, primarily related to acquisition-related costs and continued actions associated with our previously announced restructuring activities. The associated pre-tax amount of $22 was recorded as Cost of sales before special charges ($3), a Special Charge to Cost of sales ($2), Selling, general & administrative expense ($1) and Special charges ($16).

Third quarter 2013 adjusted net earnings attributable to St. Jude Medical, Inc. and adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. also exclude an income tax benefit of $15 million, or $0.05 per share, related to the settlement of domestic tax audits.

 

(3)  First nine months 2014 adjusted net earnings attributable to St. Jude Medical, Inc. and adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. exclude the following after-tax items totaling $85 or $0.30 per share:

- $77 charges, or $0.26 per share, primarily related to restructuring activities. The associated pre-tax amount of $110 was recorded as a Special Charge to Cost of sales ($28) and Special charges ($82).

- $24 charges, or $0.08 per share, of acquisition-related costs primarily related to contingent consideration fair value adjustments, acquired inventory step-up amortization expense and other transaction costs.

The associated pre-tax amount of $48 was recorded to Cost of sales before special charges ($2) and Selling, general & administrative expense ($46).

- $33 charges, or $0.12 per share, related to product field action costs and litigation costs. The associated pre-tax amount of $46 was recorded as a Special charge to Cost of sales ($23) and Special charges ($23).

- $16 charges, or $0.06 per share, related to intangible asset impairment charges. The associated pre-tax amount of $25 was recorded to Special charges.

- $17 benefit, or $0.06 per share, related to a favorable judgment and resolution of a patent infringement case. The associated pre-tax amount of $27 was recorded as a benefit to Special charges.

- $48 income tax benefit, or $0.16 per share, related to discrete income tax adjustments.

First nine months 2014 adjusted net earnings attributable to St. Jude Medical, Inc. and adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. include $12 of income tax benefit, or $0.03 per share, for the first nine months expected benefit from the federal research and development tax credit not yet extended for 2014.

 

(4)  First nine months 2013 adjusted net earnings attributable to St. Jude Medical, Inc. and adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. exclude the following after-tax items totaling $200 or $0.69 per share:

- $113 charges, or $0.38 per share, primarily related to transaction costs, acquired inventory step-up amortization expense and other acquisition-related costs and continued actions associated with our previously announced restructuring activities. The associated pre-tax amount of $141 was recorded as Cost of sales before special charges ($4), a Special Charge to Cost of sales ($21), Selling, general & administrative expense ($4), Special charges ($83) and Other expense, net ($29).

- $14 charges, or $0.05 per share, related to a license dispute settlement charge. The associated pre-tax amount of $22 was recorded to Special charges.

- $8 charges, or $0.03 per share, related to intangible asset impairment charges. The associated pre-tax amount of $13 was recorded to Special charges.

- $101 charges, or $0.35 per share related to debt retirement costs primarily associated with the make-whole provisions of long-term notes retired in the second quarter of 2013 prior to their scheduled maturities.

The associated pre-tax amount of $161 was recorded to Other expense, net.

-$21 income tax benefit, or $0.07 per share, for the benefit relating to 2012 from the federal research and development tax credit extended in the first quarter of 2013, retroactive to the beginning of the 2012 tax year.

-$15 income tax benefit, or $0.05 per share, for the benefit related to the settlement of domestic tax audits.

 


 


 

 

 

2014 Earnings Guidance Reconciliation

 

 

 

Fourth Quarter 2014

 

 

 

Full Year 2014

 

 

 

 

 

 

 

 

 

 

 

Estimated 2014 diluted net earnings per share attributable to St. Jude Medical,Inc.

 

$ 0.93 - $ 0.95

 

 

 

$ 3.55 - $ 3.57

 

 

Restructuring charges

 

0.05

 

(5)

 

0.31 

 

(5)

Acquisition-related charges

 

0.06

 

(6)

 

0.14 

 

(6)

Product litigation costs and other legal matter adjustments

 

(0.04)

 

(7)

 

0.02 

 

(7)

Intangible asset impairment charges

 

-

 

 

 

0.06 

 

(8)

Discrete income tax adjustments

 

-

 

 

 

(0.16)

 

(9)

Federal R&D tax credit 2014 extension

 

0.02 

 

(10)

 

0.05 

 

(10)

Estimated 2014 adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. (Non-GAAP)

 

$ 1.02- $ 1.04

 

 

 

$ 3.97 - $ 3.99

 

 

 

(5)         The Company’s above estimated 2014 adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. (Non-GAAP) excludes the impact of after-tax charges expected to be recognized related to ongoing business restructuring activities.

(6)         The Company’s above estimated 2014 adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. (Non-GAAP) excludes the impact of after-tax charges expected to be recognized related to acquisition-related activities.

(7)         The Company’s above estimated 2014 adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. (Non-GAAP) excludes the impact of after-tax items expected to be recognized related to product field action costs, litigation costs and the favorable judgment and resolution of patent infringement matters.

(8)         The Company’s above estimated 2014 adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. (Non-GAAP) excludes the impact of after-tax items recognized in the third quarter of 2014 related to intangible asset impairment charges.

(9)         The Company’s above estimated 2014 adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. (Non-GAAP) excludes the impact of discrete income tax benefits recognized in the second and third quarters of 2014.

(10)  The federal research and development tax credit has not yet been extended for 2014.  The Company’s above estimated 2014 adjusted diluted net earnings per share attributable to St. Jude Medical, Inc. (non-GAAP) assumes that the tax credit will be enacted for the full year 2014.

 

Reconciliation to Constant Currency Sales Growth Guidance

(in millions)

 

(unaudited)

 

 

 

Estimated 4Q14

 

 

 

4Q13

 

 

Estimated
4Q14 %
Change vs.
4Q13

 

Estimated
Constant
Currency %
Change vs.
4Q13

 

 

Estimated
Net Sales
Change vs.
4Q13

 

Estimated
Constant
Currency Net
Sales Change
vs. 4Q13

Total Sales

$1,385 - $1,465

$1,422

(3)% - 3%

1% - 7%

($37) - $43

$13 - $103

 

Reconciliation to Constant Currency Sales Growth Guidance

(in millions)

 

(unaudited)

 

 

Estimated Full
Year 2014

 

 

 

Full Year 2013

 

 

Estimated
2014 %
Change vs.
2013

 

Estimated
Constant
Currency %
Change vs.
2013

 

 

Estimated
Net Sales
Change vs.
2013

 

Estimated
Constant
Currency Net
Sales Change
vs. 2013

Total Sales

$5,568 - $5,648

$5,501

1% - 3%

3% - 4%

$67 - $147

$137 - $227

 

Reconciliation to Constant Currency Adjusted Diluted Net Earnings per Share Growth Guidance

(unaudited)

 

 

 

 

 

Estimated
Full Year
2014

 

 

Full Year
2013

 

 

Estimated
2014 %
Change vs.
2013

 

Estimated
Constant
Currency %
Change vs.
2013

 

 

 

Estimated Adj
EPS Change
vs. 2013

 

Estimated
Constant
Currency Adj
EPS Change
vs. 2013

Adjusted Diluted Net Earnings per Share (EPS)

$3.97 - $3.99

$3.76

6%

7% - 8%

$0.21 - $0.23

$0.28 - $0.30