EX-99.1 2 a14-4974_1ex99d1.htm EX-99.1

Exhibit 99.1

 

GRAPHIC

News Release

 

 

 

Media Contacts:

Kelley Dougherty

Investor Contacts:

Carol Ferguson

 

(908) 423-4291

 

(908) 423-4465

 

 

 

 

 

Steve Cragle

 

Joe Romanelli

 

(908) 423-3461

 

(908) 423-5185

 

Merck Announces Fourth-Quarter and Full-Year 2013 Financial Results

 

·                  Fourth-Quarter 2013 Non-GAAP EPS Increased by 6 Percent Over Prior Year to $0.88, Excluding Certain Items; GAAP EPS Decreased by 13 Percent to $0.26. Full-Year 2013 Non-GAAP EPS of $3.49, Excluding Certain Items; GAAP EPS of $1.47.

 

·                  Fourth-Quarter 2013 Worldwide Sales Were $11.3 Billion, a Decrease of 4 Percent Reflecting Unfavorable Impact of Patent Expiries and a 3 Percent Negative Impact from Foreign Exchange.

 

·                  Full-Year 2013 Worldwide Sales Were $44.0 Billion, a Decrease of 7 Percent Reflecting Unfavorable Impact of Patent Expiries and a 2 Percent Negative Impact from Foreign Exchange.

 

·                  Strong Full-Year Sales Growth for GARDASIL, REMICADE, SIMPONI, ISENTRESS, ZOSTAVAX and the Diabetes Franchise.

 

·                  Returned $11 Billion to Shareholders in 2013 Through Dividends and Share Repurchases.

 

·                  Accelerated Development Program for MK-3475, Including Announcement of Four Collaborations to Evaluate Novel Combination Regimens, Initiation of a Phase I Study in 20 New Cancer Types and Rolling Submission of a BLA to the FDA.

 

·                  2014 Full-Year Non-GAAP EPS Target of $3.35 to $3.53, Excluding Certain Items; GAAP EPS Range of $2.15 to $2.47.

 

WHITEHOUSE STATION, N.J., Feb. 5, 2014 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2013.

 

$ in millions, except EPS amounts

 

Fourth
Quarter
2013

 

Fourth
Quarter
2012

 

Year Ended
Dec. 31,
2013

 

Year Ended
Dec. 31,
2012

 

Sales

 

$11,319

 

$11,738

 

$44,033

 

$47,267

 

GAAP EPS

 

0.26

 

0.30

 

1.47

 

2.00

 

Non-GAAP EPS that excludes items listed below1

 

0.88

 

0.83

 

3.49

 

3.82

 

GAAP Net Income2

 

781

 

908

 

4,404

 

6,168

 

Non-GAAP Net Income that excludes items listed below1,2

 

2,599

 

2,540

 

10,443

 

11,743

 

 



 

Non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the fourth quarter of $0.88 and $3.49 for the full year of 2013 exclude acquisition-related costs, restructuring costs and certain other items.

 

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables that follow.

 

 

 

Fourth Quarter

 

Year Ended

 

$ in millions, except EPS amounts

 

2013

 

2012

 

Dec. 31,
2013

 

Dec. 31,
2012

 

EPS

 

 

 

 

 

 

 

 

 

GAAP EPS

 

$0.26

 

$0.30

 

$1.47

 

$2.00

 

Difference3

 

0.62

 

0.53

 

2.02

 

1.82

 

Non-GAAP EPS that excludes items listed below1

 

$0.88

 

$0.83

 

$3.49

 

$3.82

 

 

 

 

 

 

 

 

 

 

 

Net Income

 

 

 

 

 

 

 

 

 

GAAP net income2

 

$781

 

$908

 

$4,404

 

$6,168

 

Difference

 

1,818

 

1,632

 

6,039

 

5,575

 

Non-GAAP net income that excludes items listed below1,2

 

$2,599

 

$2,540

 

$10,443

 

$11,743

 

 

 

 

 

 

 

 

 

 

 

Decrease (Increase) in Net Income Due to Excluded Items:

 

 

 

 

 

 

 

 

 

Acquisition-related costs4

 

$1,348

 

$1,298

 

$5,549

 

$5,344

 

Restructuring costs

 

962

 

254

 

2,401

 

999

 

Other5

 

 

493

 

(13

)

493

 

Net decrease (increase) in income before taxes

 

2,310

 

2,045

 

7,937

 

6,836

 

Income tax (benefit) expense6

 

(492

)

(413

)

(1,898

)

(1,261

)

Decrease (increase) in net income

 

$1,818

 

$1,632

 

$6,039

 

$5,575

 

 

“In 2013 we took decisive action to sharpen our focus, reduce our cost structure and advance our innovative research and development,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “This year we are excited about the potential of our near- and

 


1     Merck is providing certain 2013 and 2012 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.  For a description of the items, see Tables 2a and 2b, including the related footnotes, attached to this release.

2     Net income attributable to Merck & Co., Inc.

3     Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS, which may be different than the amount calculated by dividing the impact of the excluded items by the weighted-average shares for the period.

4     Includes expenses for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as intangible asset impairment charges.  Also includes integration and other costs associated with mergers and acquisitions.

5     Amount for 2012 represents a net charge related to the settlement of certain shareholder litigation.

6     Includes an estimated income tax (benefit) expense on the reconciling items.  In addition, the full year amount for 2013 includes net benefits of approximately $325 million related to the settlements of certain federal income tax issues.

 

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long-term pipeline, poised for long-term growth and committed to providing continued value to patients, customers and our shareholders.”

 

Select Revenue Highlights

 

Worldwide sales were $11.3 billion for the fourth quarter of 2013, a decrease of 4 percent, which includes a 3 percent negative impact from foreign exchange compared with the fourth quarter of 2012. Full-year 2013 worldwide sales were $44.0 billion, a decrease of 7 percent, which includes a 2 percent negative impact from foreign exchange, compared to full-year 2012.

 

The following table reflects sales of the company’s top human health pharmaceutical products, as well as total sales of animal health and consumer care products.

 

$ in millions

 

Fourth
Quarter
2013

 

Fourth
Quarter
2012

 

Change

 

Change
Ex-
Exchange

 

Year
Ended
Dec. 31,
2013

 

Year
Ended
Dec. 31,
2012

 

Change

 

Change
Ex-
Exchange

 

Total Sales

 

$11,319

 

$11,738

 

-4

%

-1

%

$44,033

 

$47,267

 

-7

%

-5

%

Pharmaceutical

 

9,760

 

10,085

 

-3

%

0

%

37,437

 

40,601

 

-8

%

-5

%

JANUVIA

 

1,121

 

1,134

 

-1

%

4

%

4,004

 

4,086

 

-2

%

3

%

ZETIA

 

716

 

676

 

6

%

9

%

2,658

 

2,567

 

4

%

6

%

REMICADE

 

620

 

549

 

13

%

9

%

2,271

 

2,076

 

9

%

7

%

GARDASIL

 

394

 

442

 

-11

%

-9

%

1,831

 

1,631

 

12

%

14

%

JANUMET

 

503

 

452

 

11

%

11

%

1,829

 

1,659

 

10

%

10

%

ISENTRESS

 

442

 

381

 

16

%

16

%

1,643

 

1,515

 

8

%

9

%

VYTORIN

 

436

 

435

 

0

%

-1

%

1,643

 

1,747

 

-6

%

-6

%

NASONEX

 

327

 

308

 

6

%

10

%

1,335

 

1,268

 

5

%

8

%

PROQUAD, M-M-R II and VARIVAX

 

273

 

306

 

-11

%

-10

%

1,306

 

1,273

 

3

%

3

%

SINGULAIR

 

298

 

480

 

-38

%

-31

%

1,196

 

3,853

 

-69

%

-66

%

Animal Health

 

871

 

898

 

-3

%

-1

%

3,362

 

3,399

 

-1

%

1

%

Consumer Care

 

390

 

395

 

-1

%

1

%

1,894

 

1,952

 

-3

%

-2

%

Other Revenues

 

298

 

360

 

-17

%

-19

%

1,340

 

1,315

 

2

%

-1

%

 

Pharmaceutical Revenue Performance

 

Fourth-quarter pharmaceutical sales declined 3 percent to $9.8 billion, including a 3 percent negative impact due to foreign exchange. Strong sales growth for REMICADE (infliximab), ISENTRESS (raltegravir), SIMPONI (golimumab), JANUMET (sitagliptin and metformin HCI) and ZOSTAVAX (zoster vaccine live) offset the expected declines in sales of SINGULAIR (montelukast sodium), MAXALT (rizatriptan benzoate) and TEMODAR (temozolomide) following loss of market exclusivity. Full-year pharmaceutical sales declined 8 percent to $37.4 billion, including a 3 percent negative impact due to foreign exchange.

 

Sales from emerging markets grew 2 percent, including a 6 percent negative impact due to foreign exchange, and accounted for approximately 21 percent of pharmaceutical sales in the

 

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fourth quarter. Sales growth in the emerging markets was driven by vaccines, acute care and diabetes products. Full-year sales from emerging markets grew 3 percent, including a 4 percent negative impact due to foreign exchange.

 

Worldwide sales of the combined diabetes franchise of JANUVIA (sitagliptin)/JANUMET, medicines that help lower blood sugar levels in adults with type-2 diabetes, were $1.6 billion in the fourth quarter of 2013, growing 2 percent compared to the prior year quarter, including a negative 4 percent impact from foreign exchange, primarily driven by growth in Europe and the emerging markets. The combined franchise had sales of $5.8 billion for the full year of 2013, an increase of 2 percent compared with the prior year, including a negative 3 percent impact from foreign exchange.

 

Sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, were $1.2 billion in the fourth quarter, growing 4 percent compared to the prior year quarter, including a 1 percent negative impact from foreign exchange. The combined ZETIA/VYTORIN franchise had sales of $4.3 billion for the full year of 2013, comparable to the prior year.

 

Combined sales of REMICADE and SIMPONI, treatments for inflammatory diseases, increased 19 percent to $766 million for the fourth quarter of 2013, including a 4 percent benefit from foreign exchange. Global combined sales for the full year increased to $2.8 billion, 15 percent over the prior year, including a 2 percent benefit from foreign exchange. These increases were driven by market growth trends and continued launch activities for SIMPONI. SIMPONI sales were $500 million for the full year of 2013.

 

Sales recorded by Merck for GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], a vaccine to help prevent certain diseases caused by four types of human papillomavirus (HPV), decreased 11 percent to $394 million for the fourth quarter, including a 2 percent negative impact from foreign exchange. This decrease was driven by lower sales in the United States as a result of the timing of public sector purchases and in Japan reflecting the government’s decision to suspend active promotion of HPV vaccines. These declines were partially offset by growth in the emerging markets. Worldwide sales of GARDASIL recorded by Merck for the full year were $1.8 billion, a 12 percent increase compared to the prior year, including a 2 percent unfavorable impact from foreign exchange.

 

Sales of ISENTRESS, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, increased 16 percent to $442 million in the fourth quarter driven by growth in most markets. Global sales of ISENTRESS for the full year of 2013 were $1.6 billion, an 8 percent increase compared to 2012.

 

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Worldwide sales of SINGULAIR, a once-a-day oral medicine for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, declined 38 percent to $298 million in the fourth quarter. Full-year 2013 worldwide sales for SINGULAIR were $1.2 billion, a 69 percent decrease compared to the prior year. The patent for SINGULAIR expired in the United States in August 2012 and in major European markets in February 2013.

 

Sales recorded by Merck for ZOSTAVAX, a vaccine for the prevention of herpes zoster, grew 18 percent to $264 million in the fourth quarter compared to the prior year quarter, driven by new launches, primarily in Asia. Global sales of ZOSTAVAX recorded by Merck for the full year of 2013 grew 16 percent to $758 million.

 

Animal Health Revenue Performance

 

Global sales of Animal Health products totaled $871 million for the fourth quarter of 2013, a 3 percent decline compared with the same period last year, including a 2 percent negative impact due to foreign exchange. Revenue performance in the quarter reflects lower sales of ruminant products, which were partially offset by growth in poultry and aqua products. Global sales for the full year of 2013 were $3.4 billion, a decline of 1 percent, including a 2 percent negative impact from foreign exchange, when compared with 2012. Lower sales of ruminant products were partially offset by growth in companion animal and poultry products. During the third quarter of 2013, Merck Animal Health voluntarily suspended the sale of ZILMAX (zilpaterol hydrochloride), a feed supplement for beef cattle, in the United States and Canada.

 

Consumer Care Revenue Performance

 

Fourth-quarter global sales of Consumer Care were $390 million, a decrease of 1 percent, including a 2 percent negative impact from foreign exchange, compared to the fourth quarter of 2012. Full-year 2013 global sales were $1.9 billion, a 3 percent decrease compared to full-year 2012, including a 1 percent negative impact due to foreign exchange.

 

Other Revenue Performance

 

Other revenues — primarily comprised of alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales — decreased 17 percent to $298 million in the fourth quarter driven by lower revenue from AstraZeneca (AZ) recorded by Merck as well as by lower third-party manufacturing sales. Other revenues increased 2 percent to $1.3 billion for the full year of 2013. Merck anticipates that AZ will exercise its option to buy Merck’s interest in a subsidiary and, through it, Merck’s interest in Nexium and Prilosec.  If AZ does so, as of July 1,

 

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2014, Merck will no longer record equity income from AZ and supply sales to AZ are expected to terminate. The company recorded $920 million of revenue and $352 million of equity income from AZ for the full year of 2013.

 

Fourth-Quarter and Full-Year Expense and Other Information

 

The costs detailed below totaled $10.0 billion on a GAAP basis for the fourth quarter of 2013 and include $2.3 billion of acquisition-related costs and restructuring costs.

 

$ in millions

 

GAAP

 

Acquisition-Related
Costs4

 

Restructuring
Costs

 

Non-GAAP1

 

Fourth Quarter 2013

 

 

 

 

 

 

 

 

 

Materials and production

 

$4,607

 

$1,301

 

$253

 

$3,053

 

Marketing and administrative

 

2,982

 

32

 

81

 

2,869

 

Research and development

 

1,836

 

15

 

63

 

1,758

 

Restructuring costs

 

565

 

 

565

 

 

Fourth Quarter 2012

 

 

 

 

 

 

 

 

 

Materials and production

 

$4,160

 

$1,185

 

$40

 

$2,935

 

Marketing and administrative

 

3,390

 

89

 

20

 

3,281

 

Research and development

 

2,224

 

24

 

3

 

2,197

 

Restructuring costs

 

191

 

 

191

 

 

 

The costs detailed below totaled $38.1 billion on a GAAP basis for full-year 2013 and include $8.0 billion of acquisition-related costs and restructuring costs.

 

$ in millions

 

GAAP

 

Acquisition-Related
Costs4

 

Restructuring
Costs

 

Non-GAAP1

 

Year Ended Dec. 31, 2013

 

 

 

 

 

 

 

 

 

Materials and production

 

$16,954

 

$5,176

 

$446

 

$11,332

 

Marketing and administrative

 

11,911

 

94

 

145

 

11,672

 

Research and development

 

7,503

 

279

 

101

 

7,123

 

Restructuring costs

 

1,709

 

 

1,709

 

 

Year Ended Dec. 31, 2012

 

 

 

 

 

 

 

 

 

Materials and production

 

$16,446

 

$4,872

 

$188

 

$11,386

 

Marketing and administrative

 

12,776

 

272

 

90

 

12,414

 

Research and development

 

8,168

 

200

 

57

 

7,911

 

Restructuring costs

 

664

 

 

664

 

 

 

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The gross margin was 59.3 percent for the fourth quarter of 2013 compared to 64.6 percent for last year’s fourth quarter, reflecting unfavorable impacts of 13.7 and 10.4 percentage points, respectively, from the acquisition-related and restructuring costs noted above. The gross margin was 61.5 percent for the full year of 2013 compared to 65.2 percent for the full year of 2012, reflecting unfavorable impacts of 12.8 and 10.7 percentage points, respectively, from the acquisition-related and restructuring costs noted above. The non-GAAP gross margin declines in the fourth quarter and full year of 2013 reflect the unfavorable impacts of recent patent expiries, product mix and continued pricing pressure in mature markets.

 

Marketing and administrative expenses, on a non-GAAP basis, were $2.9 billion in the fourth quarter of 2013, a decrease from $3.3 billion in last year’s fourth quarter.  Full-year marketing and administrative expenses in 2013, on a non-GAAP basis, were $11.7 billion, a decrease from $12.4 billion in 2012. The declines were primarily due to productivity measures and the beneficial impact of foreign exchange.

 

Research and development (R&D) expenses, on a non-GAAP basis, were $1.8 billion in the fourth quarter of 2013, a decrease from $2.2 billion in the fourth quarter of 2012. For full-year 2013, these expenses, on a non-GAAP basis, were $7.1 billion, a decrease from $7.9 billion in 2012. The declines reflect targeted reductions and lower clinical development spend as a result of portfolio prioritization and increased focus on the company’s key therapeutic opportunities, as well as lower payments for licensing activity.

 

Equity income from affiliates was $53 million for the fourth quarter and $404 million for the full year, which primarily reflects partnerships with AZ and Sanofi Pasteur.

 

Other (income) expense, net, was $157 million of expense in the fourth quarter of 2013 compared with $669 million of expense in last year’s fourth quarter, and for the full-year 2013 was $815 million of expense compared with $1.1 billion of expense in 2012. The fourth quarter of 2012 includes a $493 million net charge related to the settlement of certain shareholder litigation.

 

Key Developments

 

Clinical

 

·                  Accelerated development program for MK-3475, the company’s anti-PD-1 immunotherapy, including announcement of four collaborations to evaluate novel combination regimens and initiation of a Phase I study in 20 new cancer types;

 

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·                  Interim data for MK-5172/MK-8742, the company’s investigational oral combination regimen for treatment of chronic hepatitis C virus (HCV), presented at the 2013 American Association for the Study of Liver Diseases Annual Meeting showed sustained virologic response in 100 percent of patients reaching post-treatment follow-up week 12 in two of the three combination arms studied;

 

·                  MK-5172/MK-8742 advanced into Phase IIB in a diverse range of chronic HCV patients;

 

·                  Interim data for MK-3475, presented at the 10th International Congress of the Society for Melanoma Research, showed an estimated survival rate of 81 percent at one year in patients with advanced melanoma;

 

·                  Phase III data on V503, the company’s 9-valent HPV vaccine candidate, showed prevention of 97 percent of cervical, vaginal and vulvar pre-cancers caused by five additional HPV types;

 

·                  Phase III trials for MK-8931, the company’s investigational BACE inhibitor for Alzheimer’s disease, were initiated; and

 

·                  BACE inhibitor dosing in Phase III study of prodromal disease patients is planned.

 

Regulatory

 

·                  Breakthrough Therapy designation was granted by U.S. Food and Drug Administration (FDA) for MK-5172/MK-8742;

 

·                  FDA advisory committee recommended approval of vorapaxar, Merck’s investigational antiplatelet medicine; and

 

·                  FDA advisory committee discussed GRASTEK (Timothy Grass Pollen Allergen Extract) and RAGWITEK (Short Ragweed Pollen Allergen Extract), Merck’s investigational sublingual allergy immunotherapy tablets.

 

Business

 

·                  $11 billion returned to shareholders in 2013 through dividends and share repurchases;

 

·                  Divested a portion of the company’s U.S. ophthalmics business; and

 

·                  In January 2014, sold the U.S. marketing rights for SAPHRIS; announced plans to divest Sirna Therapeutics, Inc. to Alnylam Pharmaceuticals, Inc.

 

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Looking Ahead

 

·                  Rolling submission for MK-3475 in patients with advanced melanoma who have previously been treated with ipilimumab to be completed in first half of 2014; and

 

·                  New Drug Applications anticipated to the FDA for odanacatib for osteoporosis, suvorexant for insomnia and sugammadex sodium injection for reversal of neuromuscular blockade induced by rocuronium or vecuronium.

 

·                  Anticipate regulatory actions for:

 

·                  V503 (submitted Biologics License Application to the FDA in 2013);

 

·                  Vintafolide in the European Union for use in platinum-resistant ovarian cancer;

 

·                  Vorapaxar for the reduction of atherothrombotic events when added to standard of care in patients with a history of heart attack and no history of stroke or transient ischemic attack;

 

·                  NOXAFIL IV for fungal infections;

 

·                  Vaniprevir in Japan for the treatment of chronic HCV;

 

·                  Allergy immunotherapies GRASTEK and RAGWITEK;

 

·                  Exploring strategic options for the company’s Animal Health and Consumer Care businesses to determine the most value-creating option for each and could reach different decisions about the two businesses.  The company expects to complete the process and take action, if any, in 2014; and

 

·                  Merck will hold an R&D event for investors and media scheduled for May 6, 2014.

 

Financial Targets

 

Merck expects full-year 2014 non-GAAP EPS to be between $3.35 and $3.53, and 2014 GAAP EPS to be between $2.15 and $2.47. The 2014 non-GAAP range excludes acquisition-related costs and costs related to restructuring programs, as well as potential gains associated with the expected termination of the AZ joint venture. The 2014 EPS targets (both non-GAAP and GAAP) include a potential devaluation of the Venezuelan Bolivar.

 

Merck expects full-year 2014 revenues to be between $42.4 billion and $43.2 billion at today’s currency rates. This includes the expectation that AZ will elect to end the partnership between the companies at mid-year, as well as lost revenue from patent expirations across multiple markets and recently announced product divestitures.

 

In addition, the company expects full-year 2014 non-GAAP marketing and administrative as well as R&D expenses to be below 2013 levels due to continuing prioritization and focused spending on core product lines and upcoming launches.

 

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The company expects its full-year 2014 non-GAAP tax rate to be in the range of 24 to 26 percent; the rate does not include a 2014 benefit of an R&D tax credit.

 

A reconciliation of anticipated 2014 EPS as reported in accordance with GAAP to non-GAAP EPS that excludes certain items is provided in the table below.

 

$ in millions, except EPS amounts

 

Full-Year 2014

 

GAAP EPS

 

$2.15 to $2.47

 

Difference3

 

1.20 to 1.06

 

Non-GAAP EPS that excludes items listed below

 

$3.35 to $3.53

 

 

 

 

 

Acquisition-related costs4

 

$4,600 to $4,350

 

Restructuring costs

 

1,300 to 1,000

 

Gain on AZ option exercise

 

(700) to (725)

 

Net decrease (increase) in income before taxes

 

5,200 to 4,625

 

Estimated income tax (benefit) expense

 

(1,675) to (1,535)

 

Decrease (increase) in net income

 

$3,525 to $3,090

 

 

Total Employees

 

As of Dec. 31, 2013, Merck had approximately 76,000 employees worldwide. In addition, the company’s joint ventures in China and Brazil, which are included in the consolidated results of Merck, had about 1,300 employees.

 

Earnings Conference Call

 

Investors are invited to a live audio webcast of Merck’s fourth-quarter earnings conference call today at 8:00 a.m. EST by visiting Merck’s website, www.merck.com/investors/events-and-presentations/home.html.  Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 26402847. Journalists are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 26402847. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

 

About Merck

 

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching

 

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policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

 

Merck Forward-Looking Statement

 

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

# # #

 

Page 11



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1

 

 

 

GAAP

 

 

 

GAAP

 

 

 

 

 

4Q13

 

4Q12

 

% Change

 

Full Year
2013

 

Full Year
2012

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales

 

$

11,319

 

$

11,738

 

-4

%

$

44,033

 

$

47,267

 

-7

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production (1)

 

4,607

 

4,160

 

11

%

16,954

 

16,446

 

3

%

Marketing and administrative (1)

 

2,982

 

3,390

 

-12

%

11,911

 

12,776

 

-7

%

Research and development (1)

 

1,836

 

2,224

 

-17

%

7,503

 

8,168

 

-8

%

Restructuring costs (2)

 

565

 

191

 

 

*

1,709

 

664

 

 

*

Equity income from affiliates (3)

 

(53

)

(231

)

-77

%

(404

)

(642

)

-37

%

Other (income) expense, net (1) (4)

 

157

 

669

 

-77

%

815

 

1,116

 

-27

%

Income Before Taxes

 

1,225

 

1,335

 

-8

%

5,545

 

8,739

 

-37

%

Income Tax Provision

 

410

 

385

 

 

 

1,028

 

2,440

 

 

 

Net Income

 

815

 

950

 

-14

%

4,517

 

6,299

 

-28

%

Less: Net Income Attributable to Noncontrolling Interests

 

34

 

42

 

 

 

113

 

131

 

 

 

Net Income Attributable to Merck & Co., Inc.

 

$

781

 

$

908

 

-14

%

$

4,404

 

$

6,168

 

-29

%

Earnings per Common Share Assuming Dilution

 

$

0.26

 

$

0.30

 

-13

%

$

1.47

 

$

2.00

 

-27

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

2,959

 

3,074

 

 

 

2,996

 

3,076

 

 

 

Tax Rate (5)

 

33.5

%

28.8

%

 

 

18.5

%

27.9

%

 

 

 

* 100% or greater

 

(1) Amounts include the impact of acquisition-related costs, restructuring costs and certain other items. See accompanying tables for details.

 

(2) Represents separation and other related costs associated with restructuring activities under the company’s formal restructuring programs.

 

(3) Primarily reflects equity income from the AstraZeneca LP and Sanofi Pasteur MSD partnerships.

 

(4) Other (income) expense, net in the fourth quarter and full year of 2012 reflect a $493 million net charge related to the settlement of certain shareholder litigation.

 

(5) The effective tax rate for the full year of 2013 reflects net benefits from the settlements of certain federal income tax issues, reductions in tax reserves upon expiration of applicable statute of limitations and the favorable impact of tax legislation enacted in the first quarter of 2013. The effective tax rates for the fourth quarter and full year of 2012 reflect a favorable ruling on a state tax matter. In addition, the effective tax rate for the full year of 2012 reflects the favorable impacts of a settlement with a foreign tax authority and the realization of foreign tax credits.

 



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS

GAAP TO NON-GAAP RECONCILIATION

FOURTH QUARTER 2013

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2a

 

 

 

GAAP

 

Acquisition-
Related Costs 
(1)

 

Restructuring
Costs 
(2)

 

Adjustment
Subtotal

 

Non-GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales

 

$

11,319

 

 

 

 

 

 

 

$

11,319

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

4,607

 

1,301

 

253

 

1,554

 

3,053

 

Marketing and administrative

 

2,982

 

32

 

81

 

113

 

2,869

 

Research and development

 

1,836

 

15

 

63

 

78

 

1,758

 

Restructuring costs

 

565

 

 

 

565

 

565

 

 

Equity income from affiliates

 

(53

)

 

 

 

 

 

(53

)

Other (income) expense, net

 

157

 

 

 

 

 

 

157

 

Income Before Taxes

 

1,225

 

(1,348

)

(962

)

(2,310

)

3,535

 

Taxes on Income

 

410

 

 

 

 

 

(492

)(3)

902

 

Net Income

 

815

 

 

 

 

 

(1,818

)

2,633

 

Less: Net Income Attributable to Noncontrolling Interests

 

34

 

 

 

 

 

 

34

 

Net Income Attributable to Merck & Co., Inc.

 

$

781

 

 

 

 

 

$

(1,818

)

$

2,599

 

Earnings per Common Share Assuming Dilution

 

$

0.26

 

 

 

 

 

 

 

$

0.88

 

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

2,959

 

 

 

 

 

 

 

2,959

 

Tax Rate

 

33.5

%

 

 

 

 

 

 

25.5

%

 

Merck is providing non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance.  This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.

 

(1) Amounts included in materials and production costs reflect expenses of $1.1 billion for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as $156 million of impairment charges on product intangibles.  Amounts included in marketing and administrative expenses reflect merger integration costs. Amounts included in research and development expenses represent in-process research and development (“IPR&D”) impairment charges.

 

(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to actions under the company’s formal restructuring programs.

 

(3) Represents the estimated tax impact on the reconciling items.

 



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS

GAAP TO NON-GAAP RECONCILIATION

FULL YEAR 2013

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2b

 

 

 

GAAP

 

Acquisition-
Related Costs 
(1)

 

Restructuring
Costs 
(2)

 

Certain Other
Items

 

Adjustment
Subtotal

 

Non-GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales

 

$

44,033

 

 

 

 

 

 

 

 

 

$

44,033

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

16,954

 

5,176

 

446

 

 

 

5,622

 

11,332

 

Marketing and administrative

 

11,911

 

94

 

145

 

 

 

239

 

11,672

 

Research and development

 

7,503

 

279

 

101

 

 

 

380

 

7,123

 

Restructuring costs

 

1,709

 

 

 

1,709

 

 

 

1,709

 

 

Equity income from affiliates

 

(404

)

 

 

 

 

 

 

 

(404

)

Other (income) expense, net

 

815

 

 

 

 

 

(13

)

(13

)

828

 

Income Before Taxes

 

5,545

 

(5,549

)

(2,401

)

13

 

(7,937

)

13,482

 

Taxes on Income

 

1,028

 

 

 

 

 

 

 

(1,898

)(3)

2,926

 

Net Income

 

4,517

 

 

 

 

 

 

 

(6,039

)

10,556

 

Less: Net Income Attributable to Noncontrolling Interests

 

113

 

 

 

 

 

 

 

 

113

 

Net Income Attributable to Merck & Co., Inc.

 

$

4,404

 

 

 

 

 

 

 

$

(6,039

)

$

10,443

 

Earnings per Common Share Assuming Dilution

 

$

1.47

 

 

 

 

 

 

 

 

 

$

3.49

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

2,996

 

 

 

 

 

 

 

 

 

2,996

 

Tax Rate

 

18.5

%

 

 

 

 

 

 

 

 

21.7

%

 

Merck is providing non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance.  This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.

 

(1) Amounts included in materials and production costs reflect expenses of $4.7 billion for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as $486 million of impairment charges on product intangibles.  Amounts included in marketing and administrative expenses reflect merger integration costs.  Amounts included in research and development expenses represent in-process research and development (“IPR&D”) impairment charges.

 

(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to actions under the company’s formal restructuring programs.

 

(3) Represents the estimated tax impact on the reconciling items, as well as net benefits of approximately $325 million related to the settlements of certain federal income tax issues.

 



 

MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)

Table 3

 

 

 

2013

 

2012

 

% Change

 

% Change

 

 

 

1Q

 

2Q

 

3Q

 

4Q

 

Full Year

 

1Q

 

2Q

 

3Q

 

4Q

 

Full Year

 

4Q

 

Full Year

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL SALES (1)

 

$

10,671

 

$

11,010

 

$

11,032

 

$

11,319

 

$

44,033

 

$

11,731

 

$

12,311

 

$

11,488

 

$

11,738

 

$

47,267

 

-4

 

-7

 

PHARMACEUTICAL

 

8,891

 

9,310

 

9,475

 

9,760

 

37,437

 

10,082

 

10,560

 

9,875

 

10,085

 

40,601

 

-3

 

-8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Primary Care and Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

629

 

650

 

662

 

716

 

2,658

 

614

 

632

 

645

 

676

 

2,567

 

6

 

4

 

Vytorin

 

394

 

417

 

396

 

436

 

1,643

 

444

 

445

 

423

 

435

 

1,747

 

 

 

-6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diabetes & Obesity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Januvia

 

884

 

1,072

 

927

 

1,121

 

4,004

 

919

 

1,058

 

975

 

1,134

 

4,086

 

-1

 

-2

 

Janumet

 

409

 

474

 

442

 

503

 

1,829

 

392

 

411

 

405

 

452

 

1,659

 

11

 

10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nasonex

 

385

 

325

 

297

 

327

 

1,335

 

375

 

293

 

292

 

308

 

1,268

 

6

 

5

 

Singulair

 

337

 

281

 

280

 

298

 

1,196

 

1,340

 

1,431

 

602

 

480

 

3,853

 

-38

 

-69

 

Dulera

 

68

 

79

 

82

 

95

 

324

 

39

 

50

 

52

 

67

 

207

 

42

 

56

 

Asmanex

 

40

 

49

 

43

 

51

 

184

 

48

 

51

 

42

 

44

 

185

 

17

 

-1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Women’s Health & Endocrine

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NuvaRing

 

151

 

171

 

170

 

193

 

686

 

146

 

157

 

156

 

164

 

623

 

17

 

10

 

Fosamax

 

137

 

144

 

140

 

139

 

560

 

184

 

186

 

152

 

154

 

676

 

-10

 

-17

 

Follistim AQ

 

122

 

134

 

124

 

101

 

481

 

116

 

125

 

111

 

116

 

468

 

-13

 

3

 

Implanon

 

84

 

102

 

96

 

120

 

403

 

76

 

85

 

93

 

94

 

348

 

28

 

16

 

Cerazette

 

61

 

48

 

51

 

50

 

208

 

67

 

72

 

64

 

68

 

271

 

-28

 

-23

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Arcoxia

 

121

 

121

 

112

 

131

 

484

 

112

 

117

 

109

 

115

 

453

 

13

 

7

 

Avelox

 

36

 

29

 

38

 

37

 

140

 

73

 

44

 

30

 

55

 

201

 

-32

 

-31

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hospital and Specialty

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Immunology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remicade

 

549

 

527

 

574

 

620

 

2,271

 

519

 

518

 

490

 

549

 

2,076

 

13

 

9

 

Simponi

 

108

 

120

 

126

 

146

 

500

 

74

 

76

 

86

 

95

 

331

 

53

 

51

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Infectious Disease

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Isentress

 

362

 

412

 

427

 

442

 

1,643

 

337

 

398

 

399

 

381

 

1,515

 

16

 

8

 

Cancidas

 

162

 

163

 

151

 

183

 

660

 

145

 

166

 

163

 

145

 

619

 

26

 

7

 

PegIntron

 

126

 

142

 

104

 

124

 

496

 

162

 

183

 

165

 

143

 

653

 

-13

 

-24

 

Invanz

 

110

 

120

 

130

 

128

 

488

 

101

 

110

 

118

 

116

 

445

 

10

 

10

 

Victrelis

 

110

 

116

 

121

 

81

 

428

 

111

 

126

 

149

 

115

 

502

 

-29

 

-15

 

Noxafil

 

65

 

71

 

75

 

98

 

309

 

59

 

66

 

66

 

68

 

258

 

44

 

20

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Temodar

 

216

 

219

 

162

 

111

 

708

 

237

 

225

 

227

 

229

 

917

 

-51

 

-23

 

Emend

 

116

 

135

 

123

 

134

 

507

 

102

 

145

 

111

 

131

 

489

 

2

 

4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cosopt / Trusopt

 

105

 

103

 

104

 

103

 

416

 

124

 

105

 

102

 

113

 

444

 

-9

 

-6

 

Bridion

 

63

 

69

 

75

 

82

 

288

 

58

 

60

 

68

 

75

 

261

 

10

 

10

 

Integrilin

 

47

 

48

 

45

 

46

 

186

 

53

 

60

 

48

 

51

 

211

 

-9

 

-12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diversified Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cozaar / Hyzaar

 

267

 

255

 

238

 

246

 

1,006

 

336

 

337

 

295

 

315

 

1,284

 

-22

 

-22

 

Primaxin

 

84

 

85

 

88

 

79

 

335

 

88

 

104

 

109

 

83

 

384

 

-5

 

-13

 

Zocor

 

82

 

74

 

65

 

79

 

301

 

103

 

96

 

86

 

98

 

383

 

-19

 

-21

 

Propecia

 

68

 

67

 

71

 

77

 

283

 

108

 

100

 

104

 

112

 

424

 

-31

 

-33

 

Clarinex

 

61

 

64

 

54

 

55

 

235

 

134

 

140

 

64

 

56

 

393

 

-1

 

-40

 

Remeron

 

52

 

53

 

44

 

56

 

206

 

57

 

66

 

52

 

57

 

232

 

-1

 

-11

 

Claritin Rx

 

76

 

40

 

36

 

52

 

204

 

87

 

48

 

47

 

63

 

244

 

-16

 

-16

 

Proscar

 

39

 

58

 

38

 

48

 

183

 

51

 

55

 

55

 

56

 

217

 

-15

 

-15

 

Maxalt

 

40

 

43

 

40

 

25

 

149

 

156

 

154

 

166

 

162

 

638

 

-85

 

-77

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gardasil

 

390

 

383

 

665

 

394

 

1,831

 

284

 

324

 

581

 

442

 

1,631

 

-11

 

12

 

ProQuad, M-M-R II and Varivax

 

272

 

339

 

421

 

273

 

1,306

 

255

 

316

 

396

 

306

 

1,273

 

-11

 

3

 

Zostavax

 

168

 

141

 

185

 

264

 

758

 

76

 

148

 

202

 

225

 

651

 

18

 

16

 

Pneumovax 23

 

111

 

108

 

193

 

241

 

653

 

112

 

101

 

160

 

208

 

580

 

16

 

13

 

RotaTeq

 

162

 

144

 

201

 

129

 

636

 

142

 

142

 

150

 

168

 

601

 

-23

 

6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Pharmaceutical (2)

 

1,022

 

1,115

 

1,059

 

1,126

 

4,316

 

1,066

 

1,034

 

1,065

 

1,161

 

4,333

 

-3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANIMAL HEALTH

 

840

 

851

 

800

 

871

 

3,362

 

821

 

865

 

815

 

898

 

3,399

 

-3

 

-1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONSUMER CARE (3)

 

571

 

490

 

443

 

390

 

1,894

 

554

 

552

 

451

 

395

 

1,952

 

-1

 

-3

 

Claritin OTC

 

177

 

78

 

123

 

92

 

471

 

169

 

145

 

118

 

100

 

532

 

-8

 

-12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Revenues (4)

 

369

 

359

 

314

 

298

 

1,340

 

274

 

333

 

347

 

360

 

1,315

 

-17

 

2

 

Astra

 

262

 

245

 

220

 

193

 

920

 

186

 

223

 

255

 

251

 

915

 

-23

 

1

 

 

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.

(1) Only select products are shown.

(2) Includes Pharmaceutical products not individually shown above. Other Vaccines sales included in Other Pharmaceutical were $53 million, $86 million, $127 million, and $101 million for the first, second, third, and fourth quarters of 2013. Other Vaccines sales included in Other Pharmaceutical were $60 million, $75 million, $116 million, and $69 million for the first, second, third, and fourth quarters of 2012, respectively.

(3) The decrease in Consumer Care sales in the second quarter and full year of 2013 resulted from the ongoing termination in China of distribution arrangements and a reversal of sales previously made to those distributors, together with associated termination costs.

(4) Other revenues are comprised primarily of alliance revenue, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities. On October 1, 2013, the Company divested a substantial portion of its third-party manufacturing sales.   In addition, Other revenues in the fourth quarter and full year of 2013 reflect $50 million of revenue for the out-license of a pipeline compound.