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EX-99.2 - EX-99.2 - Merck & Co., Inc.a12-25094_1ex99d2.htm

Exhibit 99.1

 

News Release

 

 

Media Contacts:

Ron Rogers

 

Investor Contacts:

Carol Ferguson

 

(908) 423-6449

 

 

(908) 423-4465

 

 

 

 

 

 

Steve Cragle

 

 

Justin Holko

 

(908) 423-3461

 

 

(908) 423-5088

 

Merck Announces Third-Quarter 2012 Financial Results

 

·                  2012 Third-Quarter Non-GAAP EPS Increased to $0.95, Excluding Certain Items; GAAP EPS of $0.56

 

·                  Worldwide Sales of $11.5 Billion, a Decrease of 4 Percent; Comparable to Third-Quarter 2011 Sales, Excluding the Unfavorable Impact of Foreign Exchange

 

·                  Double-Digit Global Sales Growth for JANUVIA, JANUMET, GARDASIL, VICTRELIS, ZOSTAVAX and ISENTRESS; Offset by the Decline in SINGULAIR Sales Following Patent Expiry in the United States

 

·                  Anticipates Multiple New Product Submissions in 2012-2013, Including Suvorexant and Odanacatib

 

·                  Narrows 2012 Full-Year Non-GAAP EPS Target to $3.78 to $3.82, Excluding Certain Items; GAAP EPS Range of $2.08 to $2.24

 

WHITEHOUSE STATION, N.J., Oct. 26, 2012 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2012.

 

$ in millions, except EPS amounts

 

Third
Quarter
2012

 

Third
Quarter
2011

 

Sales

 

$11,488

 

$12,022

 

GAAP EPS

 

0.56

 

0.55

 

Non-GAAP EPS that excludes items listed below1 

 

0.95

 

0.94

 

GAAP Net Income2

 

1,729

 

1,692

 

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

 

2,932

 

2,908

 

 

Non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the third quarter of $0.95 exclude acquisition-related costs and restructuring costs.

 


1                   Merck is providing certain 2012 and 2011 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 Table 2a  including the related footnotes, attached to this release.

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

 



 

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables below. Year-to-date results can be found in the attached tables.

 

 

 

Third Quarter 2012

 

Third Quarter 2011

 

$ in millions, except EPS amounts

 

Net
Income
2

 

EPS

 

Net
Income
2

 

EPS

 

GAAP

 

$1,729

 

$0.56

 

$1,692

 

$0.55

 

Difference

 

1,203

 

0.39

3

1,216

 

0.39

3

Non-GAAP that excludes items listed below1

 

$2,932

 

$0.95

 

$2,908

 

$0.94

 

 

$ in millions

 

Third
Quarter
2012

 

Third
Quarter
2011

 

 

 

 

 

Acquisition-related costs4

 

$1,340

 

$1,363

 

 

 

 

 

Restructuring costs

 

163

 

277

 

 

 

 

 

Other5

 

 

(137

)

 

 

 

 

Net decrease (increase) in income before taxes

 

1,503

 

1,503

 

 

 

 

 

Estimated income tax (benefit) expense

 

(300

)

(287

)

 

 

 

 

Decrease (increase) in net income

 

$1,203

 

$1,216

 

 

 

 

 

 

“Our strong global sales this quarter offset the impact of the SINGULAIR patent expiry in the U.S.,” said Kenneth C. Frazier, chairman and chief executive officer of Merck.  “We will continue to drive value for our customers and shareholders through Merck’s four-part strategy of executing on our core business, expanding geographically in high-growth markets, extending our complementary businesses and excelling at managing our costs while investing for growth.  With our robust pipeline, we remain on target to submit multiple new products for marketing approval between now and the end of 2013, including suvorexant for insomnia, odanacatib for osteoporosis and TREDAPTIVE for multiple lipid parameters.”

 

Select Revenue Highlights

 

Worldwide sales were $11.5 billion for the third quarter of 2012, a decrease of 4 percent. Excluding the unfavorable impact of foreign exchange, sales were comparable with the third quarter of 2011.  Strong growth of key products offset the negative impact of the August 2012 loss of market exclusivity for SINGULAIR (montelukast sodium) in the United States.

 

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

 


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.

4              Includes expenses for the amortization of intangible assets and amortization of purchase accounting adjustments to inventories 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 2011 includes a gain on the divestiture of the company’s interest in the Johnson & Johnson°Merck Consumer Pharmaceuticals Company joint venture.

 

Page 2



 

$ in millions

 

Third Quarter
2012

 

Third Quarter
2011

 

Change

 

Total Sales

 

$11,488

 

$12,022

 

-4

%

Pharmaceutical

 

9,875

 

10,354

 

-5

%

JANUVIA

 

975

 

846

 

15

%

ZETIA

 

645

 

614

 

5

%

SINGULAIR

 

602

 

1,336

 

-55

%

GARDASIL

 

581

 

445

 

31

%

REMICADE

 

490

 

561

 

-13

%

VYTORIN

 

423

 

469

 

-10

%

JANUMET

 

405

 

350

 

16

%

ISENTRESS

 

399

 

343

 

16

%

PROQUAD, M-M-R II and VARIVAX

 

396

 

391

 

1

%

COZAAR/HYZAAR

 

295

 

404

 

-27

%

Animal Health

 

815

 

826

 

-1

%

Consumer Care

 

451

 

421

 

7

%

Other Revenues

 

347

 

421

 

-17

%

 

Pharmaceutical Revenue Performance

 

Third-quarter pharmaceutical sales declined 5 percent to $9.9 billion, including a 5 percent negative impact due to foreign exchange.  Strong sales growth for GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], JANUVIA (sitagliptin), VICTRELIS (boceprevir), ZOSTAVAX (zoster vaccine live), ISENTRESS (raltegravir), and JANUMET (sitagliptin/metformin hydrochloride) offset the expected declines in sales of SINGULAIR, COZAAR (losartan potassium) and HYZAAR (losartan potassium and hydrochlorothiazide).

 

Sales from emerging markets accounted for approximately 20 percent of pharmaceutical sales in the third quarter.  Sales growth in the emerging markets is being driven by primary care and women’s health, vaccines, hospital and specialty, and diversified brands.  China continues to be a key driver with 19 percent growth for the third quarter, including a 1 percent benefit from foreign exchange.

 

Worldwide sales of the combined diabetes franchise of JANUVIA/JANUMET, medicines that help lower blood sugar levels in adults with type 2 diabetes, grew 15 percent to $1.4 billion in the third quarter of 2012 primarily driven by growth in the United States and Japan.

 

Sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, declined 1 percent to $1.1 billion in the third quarter driven by lower sales of VYTORIN, partially offset by growth of ZETIA in the United States.

 

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 $734 million, or 55 percent, to $602 million in the third quarter of 2012.  The patent for SINGULAIR expired in the United States on Aug. 3, 2012 and will expire in major European markets in February 2013.  The company is experiencing a significant and rapid reduction in sales in the United States and expects a similar decline in Europe following patent expiry there.  SINGULAIR will retain marketing exclusivity in Japan until 2016.

 

Page 3



 

Sales recorded by Merck for GARDASIL, a vaccine to help prevent certain diseases caused by four types of human papillomavirus (HPV), increased 31 percent to $581 million for the quarter driven by greater uptake in males in the United States and favorable performance in the emerging markets.

 

Combined sales of REMICADE (infliximab) and SIMPONI (golimumab), treatments for inflammatory diseases, declined 9 percent to $576 million for the third quarter of 2012.  The combined sales grew 4 percent excluding foreign exchange.

 

ISENTRESS, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, grew 16 percent to $399 million in the third quarter driven by strong growth in the United States and the emerging markets.

 

Global sales of Merck’s antihypertensive medicines COZAAR and HYZAAR were down 27 percent to $295 million in the third quarter of 2012 due to the loss of market exclusivity in the United States and major European markets in 2010.

 

Sales of ZOSTAVAX, a vaccine for the prevention of herpes zoster, grew 87 percent to $202 million in the quarter.  Growth this quarter was due to a positive response to supply availability and increased promotional efforts in the United States.

 

Sales of VICTRELIS, the company’s oral hepatitis C virus NS3/4A protease inhibitor, grew to $149 million in the quarter versus $31 million last year as the product continues to launch.  VICTRELIS is approved in 64 countries and has launched in 31 of those markets.

 

Animal Health Revenue Performance

 

Animal Health sales totaled $815 million for the third quarter of 2012, a 1 percent decrease compared with the third quarter of 2011, which includes an 8 percent negative impact due to foreign exchange.  Excluding the negative impact of foreign exchange, performance was driven by the cattle, poultry and companion animal segments.  The Animal Health division launched the ACTIVYL line of products in the United States, which is an important addition to the companion animal product line.

 

Consumer Care Revenue Performance

 

Third-quarter global sales of Consumer Care were $451 million, an increase of 7 percent compared to the third quarter of 2011, including a 3 percent negative impact due to foreign exchange.  The increase was primarily driven by the DR. SCHOLL’S footcare line and COPPERTONE suncare line.

 

Other Revenue Performance

 

Other revenues – primarily comprised of alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales – declined 17 percent to $347 million.  The

 

Page 4



 

change was driven largely by lower revenue from AstraZeneca LP (AZLP) recorded by Merck, which declined 15 percent to $255 million, as well as by lower third-party manufacturing sales.

 

Third-Quarter Expense and Other Information

 

The costs detailed below totaled $9.2 billion on a GAAP basis during the third quarter of 2012 and include $1.5 billion of acquisition-related costs and restructuring costs.

 

 

 

Included in expenses for the period

 

$ in millions

 

GAAP

 

Acquisition-
Related
Costs
4

 

Restructuring
Costs

 

Non-GAAP1

 

Third Quarter 2012

 

 

 

 

 

 

 

 

 

Materials and production

 

$4,137

 

$1,232

 

$60

 

$2,845

 

Marketing and administrative

 

3,063

 

68

 

25

 

2,970

 

Research and development

 

1,918

 

40

 

(32

)

1,910

 

Restructuring costs

 

110

 

 

110

 

 

 

 

 

 

 

 

 

 

 

 

Third Quarter 2011

 

 

 

 

 

 

 

 

 

Materials and production

 

$4,352

 

$1,284

 

$99

 

$2,969

 

Marketing and administrative

 

3,340

 

57

 

31

 

3,252

 

Research and development

 

1,954

 

22

 

28

 

1,904

 

Restructuring costs

 

119

 

 

119

 

 

 

The gross margin was 64.0 percent for the third quarter of 2012 and 63.8 percent for the third quarter of 2011, reflecting 11.2 and 11.5 percentage point unfavorable impacts, respectively, from the acquisition-related costs and restructuring costs noted above.

 

Marketing and administrative expenses, on a non-GAAP basis, were $3.0 billion in the third quarter of 2012, a decrease from $3.3 billion in the third quarter of 2011.  The decrease was primarily due to foreign exchange and productivity measures.

 

Research and development (R&D) expenses, on a non-GAAP basis, were $1.9 billion in the third quarter of 2012, which is in line with the third quarter of 2011.

 

Equity income from affiliates was $158 million for the third quarter of 2012, which primarily reflects the performance of AZLP and Sanofi Pasteur MSD.

 

Other (income) expense, net was $200 million of expense in the third quarter of 2012, compared to $66 million of expense in the third quarter of 2011.  The third quarter of 2011 reflects a $136 million gain on the divestiture of the company’s interest in the Johnson & Johnson°Merck Consumer Pharmaceuticals Company joint venture.

 

The GAAP effective tax rate of 20.5 percent for the third quarter of 2012 reflects the impact of acquisition-related costs and restructuring costs.  The non-GAAP effective tax rate, which excludes these items, was 20.3 percent for the quarter.  Both the GAAP and non-GAAP effective tax rates reflect the favorable impacts of a settlement with a foreign tax authority and the realization of foreign tax credits.

 

Page 5



 

Key Developments

 

The company noted the following developments:

·                  In October, entered into an exclusive worldwide licensing agreement for AiCuris’ late-stage antiviral candidate for the treatment and prevention of human cytomegalovirus infection in transplant recipients;

·                  Completed a study of sugammadex, a neuromuscular blocker reversal agent, to assess bleeding risk when co-administered with anticoagulants in a surgical setting.  The company remains on track to resubmit sugammadex to the FDA this year;

·                  Announced results from a Phase II trial for odanacatib, an investigational cathepsin K inhibitor in development for the treatment of osteoporosis in post-menopausal women.  In that Phase II trial, odanacatib significantly increased bone mineral density over a two-year period in patients previously treated with alendronate;

·                  Presented Phase IIb data for MK-3102, the company’s investigational once-weekly DPP-4 inhibitor in development for the treatment of type 2 diabetes. MK-3102 significantly lowered blood sugar in this 12-week study compared with placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo, in patients with type 2 diabetes.  The company has initiated the Phase III clinical program;

·                  Presented new clinical data for suvorexant that showed patients who had been taking suvorexant for 12 months and were then switched to placebo for two months saw their insomnia return, but clinically meaningful withdrawal symptoms and rebound insomnia did not emerge;

·                  Announced plans to file applications for vorapaxar, an investigational anti-thrombotic medicine, in the United States and Europe in 2013.  The company will seek an indication for the prevention of cardiovascular events in patients with a history of heart attack and no history of transient ischemic attack or stroke.

 

Financial Targets

 

Merck narrows the range of full-year 2012 non-GAAP EPS to be between $3.78 and $3.82 and the 2012 GAAP EPS range to be $2.08 to $2.24.  The 2012 non-GAAP range excludes acquisition-related costs and costs related to restructuring programs.

 

Merck continues to expect full-year 2012 revenues to be at or near 2011 levels on a constant currency basis.  At current exchange rates, sales would be affected unfavorably by approximately 1 percent for the fourth quarter and more than 2 percent for the full year.

 

In addition, the company expects full-year 2012 non-GAAP R&D expenses to be higher than the 2011 level.  The company continues to expect the full-year 2012 non-GAAP tax rate to be approximately 25 percent.

 

Page 6



 

A reconciliation of anticipated 2012 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 2012

 

GAAP EPS

 

$2.08 to $2.24

 

Difference3

 

1.70 to 1.58

 

Non-GAAP EPS that excludes items listed below

 

$3.78 to $3.82

 

 

 

 

 

Acquisition-related costs4

 

$5,300 to $5,100

 

Restructuring costs

 

1,100 to 800

 

Net decrease (increase) in income before taxes

 

6,400 to 5,900

 

Estimated income tax (benefit) expense

 

(1,160) to (1,050)

 

Decrease (increase) in net income

 

$5,240 to $4,850

 

 

Total Employees

 

As of Sept. 30, 2012, Merck had approximately 84,000 employees worldwide.

 

Earnings Conference Call

 

Investors are invited to a live audio webcast of Merck’s third-quarter earnings conference call today at 8 a.m. EDT by visiting Merck’s Internet site, 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.  Journalists are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917.  A replay of the call will be available starting at 11 a.m. EDT today for approximately one week.  To listen to the replay, dial (404) 537-3406 or (855) 859-2056 and enter ID No. 30586503.

 

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

 

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. Such statements may include, but are not limited to, statements about the benefits of the merger

 

Page 7



 

between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

 

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to 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 2011 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 8



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1

 

 

 

GAAP

 

 

 

GAAP

 

 

 

 

 

 

 

 

 

 

 

Sep YTD

 

Sep YTD

 

 

 

 

 

3Q12

 

3Q11

 

% Change

 

2012

 

2011

 

% Change

 

Sales

 

$11,488

 

 

$12,022

 

 

-4

%

 

$35,530

 

 

$35,753

 

 

-1

%

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production (1)

 

4,137

 

 

4,352

 

 

-5

%

 

12,286

 

 

12,695

 

 

-3

%

 

Marketing and administrative (1) 

 

3,063

 

 

3,340

 

 

-8

%

 

9,386

 

 

10,029

 

 

-6

%

 

Research and development (1) 

 

1,918

 

 

1,954

 

 

-2

%

 

5,944

 

 

6,048

 

 

-2

%

 

Restructuring costs (2) 

 

110

 

 

119

 

 

-8

%

 

473

 

 

773

 

 

-39

%

 

Equity income from affiliates (3)

 

(158

)

 

(161

)

 

-2

%

 

(410

)

 

(354

)

 

16

%

 

Other (income) expense, net (1)(4)

 

200

 

 

66

 

 

*

 

 

446

 

 

809

 

 

-45

%

 

Income Before Taxes

 

2,218

 

 

2,352

 

 

-6

%

 

7,405

 

 

5,753

 

 

29

%

 

Income Tax Provision

 

455

 

 

628

 

 

 

 

 

2,055

 

 

904

 

 

 

 

 

Net Income

 

1,763

 

 

1,724

 

 

2

%

 

5,350

 

 

4,849

 

 

10

%

 

Less: Net Income Attributable to Noncontrolling Interests

 

34

 

 

32

 

 

 

 

 

89

 

 

89

 

 

 

 

 

Net Income Attributable to Merck & Co., Inc.

 

$  1,729

 

 

$  1,692

 

 

2

%

 

$  5,261

 

 

$  4,760

 

 

11

%

 

Earnings per Common Share Assuming Dilution (5)

 

$    0.56

 

 

$    0.55

 

 

2

%

 

$    1.71

 

 

$    1.53

 

 

12

%

 

Average Shares Outstanding Assuming Dilution

 

3,079

 

 

3,091

 

 

 

 

 

3,077

 

 

3,102

 

 

 

 

 

Tax Rate (6)

 

20.5

%

 

26.7

%

 

 

 

 

27.8

%

 

15.7

%

 

 

 

 

 

*100% or greater

 

(1) Amounts include the impact of acquisition-related costs and restructuring costs. 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 third quarter and first nine months of 2011 includes a $136 million gain on the divestiture of the company’s interest in the Johnson & JohnsonºMerck Consumer Pharmaceuticals Company joint venture.  In addition, other (income) expense, net in the first nine months of 2011 includes a charge of $500 million related to the resolution of the arbitration proceeding with Johnson & Johnson and a $127 million gain on the sale of certain manufacturing facilities and related assets.

 

(5) The company calculates earnings per share pursuant to the two-class method which requires the allocation of net income between common shareholders and participating security holders.  Net income attributable to Merck & Co., Inc. common shareholders used to calculate earnings per common share assuming dilution was $1,729 million and $1,689 million for the third quarter of 2012 and 2011, respectively, and was $5,257 million and $4,748 million for the first nine months of 2012 and 2011, respectively.

 

(6) The GAAP effective tax rates for the third quarter and first nine months of 2012 were 20.5% and 27.8%, respectively.  Excluding the impact of the non-GAAP reconciling items detailed in the accompanying tables, the effective tax rates were 20.3% and 23.8% for the third quarter and first nine months of 2012, respectively.  Both the GAAP and non-GAAP effective tax rates for the third quarter and first nine months of 2012 reflect the favorable impacts of a settlement with a foreign tax authority and the realization of foreign tax credits.  The GAAP effective tax rates for the third quarter and first nine months of 2011 were 26.7% and 15.7%, respectively.  Excluding the impact of the non-GAAP reconciling items detailed in the accompanying tables, the effective tax rates were 23.7% and 24.5% for the third quarter and first nine months of 2011, respectively.

 



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS

GAAP TO NON-GAAP RECONCILIATION

THIRD QUARTER 2012

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2a

 

 

 

GAAP

 

Acquisition-
Related Costs 
(1)

 

Restructuring
Costs 
(2)

 

Adjustment
Subtotal

 

Non-GAAP

 

Sales

 

$

11,488

 

 

 

 

 

$

 

$

11,488

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

4,137

 

1,232

 

60

 

1,292

 

2,845

 

Marketing and administrative

 

3,063

 

68

 

25

 

93

 

2,970

 

Research and development

 

1,918

 

40

 

(32

)

8

 

1,910

 

Restructuring costs

 

110

 

 

 

110

 

110

 

 

Equity income from affiliates

 

(158

)

 

 

 

 

 

(158

)

Other (income) expense, net

 

200

 

 

 

 

 

 

200

 

Income Before Taxes

 

2,218

 

(1,340

)

(163

)

(1,503

)

3,721

 

Taxes on Income

 

455

 

 

 

 

 

(300

)(3)

755

 

Net Income

 

1,763

 

 

 

 

 

(1,203

)

2,966

 

Less: Net Income Attributable to Noncontrolling Interests

 

34

 

 

 

 

 

 

34

 

Net Income Attributable to Merck & Co., Inc.

 

$

1,729

 

 

 

 

 

$

(1,203

)

$

2,932

 

Earnings per Common Share Assuming Dilution

 

$

0.56

 

 

 

 

 

 

 

$

0.95

(4)

Average Shares Outstanding Assuming Dilution

 

3,079

 

 

 

 

 

 

 

3,079

 

Tax Rate

 

20.5

%

 

 

 

 

 

 

20.3

%

 

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 for the amortization of intangible assets recognized as a result of mergers and acquisitions.  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.  In the third quarter of 2012, the company recorded an adjustment to accelerated depreciation costs included in research and development expenses revising previously recorded amounts for certain facilities.

 

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

 

(4) The company calculates earnings per share pursuant to the two-class method which requires the allocation of net income between common shareholders and participating security holders.  Net income attributable to Merck & Co., Inc. common shareholders used to calculate non-GAAP earnings per common share assuming dilution was $2,932 million for the third quarter of 2012.

 


 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS

GAAP TO NON-GAAP RECONCILIATION

NINE MONTHS ENDED SEPTEMBER 30, 2012

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2b

 

 

 

GAAP

 

Acquisition-
Related Costs 
(1)

 

Restructuring
Costs 
(2)

 

Adjustment
Subtotal

 

Non-GAAP

 

Sales

 

$

35,530

 

 

 

 

 

$

 

$

35,530

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

12,286

 

3,687

 

148

 

3,835

 

8,451

 

Marketing and administrative

 

9,386

 

183

 

70

 

253

 

9,133

 

Research and development

 

5,944

 

176

 

54

 

230

 

5,714

 

Restructuring costs

 

473

 

 

 

473

 

473

 

 

Equity income from affiliates

 

(410

)

 

 

 

 

 

(410

)

Other (income) expense, net

 

446

 

 

 

 

 

 

446

 

Income Before Taxes

 

7,405

 

(4,046

)

(745

)

(4,791

)

12,196

 

Taxes on Income

 

2,055

 

 

 

 

 

(848

)(3)

2,903

 

Net Income

 

5,350

 

 

 

 

 

(3,943

)

9,293

 

Less: Net Income Attributable to Noncontrolling Interests

 

89

 

 

 

 

 

 

89

 

Net Income Attributable to Merck & Co., Inc.

 

$

5,261

 

 

 

 

 

$

(3,943

)

$

9,204

 

Earnings per Common Share Assuming Dilution

 

$

1.71

 

 

 

 

 

 

 

$

2.99

(4)

Average Shares Outstanding Assuming Dilution

 

3,077

 

 

 

 

 

 

 

3,077

 

Tax Rate

 

27.8

%

 

 

 

 

 

 

23.8

%

 

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 for the amortization of intangible assets recognized as a result of mergers and acquisitions.  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.

 

(4) The company calculates earnings per share pursuant to the two-class method which requires the allocation of net income between common shareholders and participating security holders.  Net income attributable to Merck & Co., Inc. common shareholders used to calculate non-GAAP earnings per common share assuming dilution was $9,198 million for the first nine months of 2012.

 



 

MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)

Table 3

 

 

 

2012

 

2011

 

% Change

 

% Change

 

 

 

1Q

 

2Q

 

3Q

 

Sep YTD

 

1Q

 

2Q

 

3Q

 

Sep YTD

 

4Q

 

Full Year

 

3Q

 

Sep YTD

 

TOTAL SALES (1)

 

$

11,731

 

$

12,311

 

$

11,488

 

$

35,530

 

$

11,580

 

$

12,151

 

$

12,022

 

$

35,753

 

$

12,294

 

$

48,047

 

-4

 

-1

 

PHARMACEUTICAL

 

10,082

 

10,560

 

9,875

 

30,517

 

9,820

 

10,360

 

10,354

 

30,534

 

10,755

 

41,289

 

-5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Primary Care and Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

614

 

632

 

645

 

1,891

 

582

 

592

 

614

 

1,788

 

640

 

2,428

 

5

 

6

 

Vytorin

 

444

 

445

 

423

 

1,312

 

480

 

459

 

469

 

1,407

 

475

 

1,882

 

-10

 

-7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diabetes & Obesity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Januvia

 

919

 

1,058

 

975

 

2,952

 

739

 

779

 

846

 

2,364

 

960

 

3,324

 

15

 

25

 

Janumet

 

392

 

411

 

405

 

1,207

 

305

 

321

 

350

 

977

 

386

 

1,363

 

16

 

24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

1,340

 

1,431

 

602

 

3,373

 

1,328

 

1,354

 

1,336

 

4,018

 

1,461

 

5,479

 

-55

 

-16

 

Nasonex

 

375

 

293

 

292

 

960

 

373

 

323

 

266

 

962

 

325

 

1,286

 

10

 

 

Clarinex

 

134

 

140

 

64

 

337

 

155

 

209

 

128

 

492

 

129

 

621

 

-50

 

-32

 

Asmanex

 

48

 

51

 

42

 

141

 

60

 

47

 

42

 

149

 

57

 

206

 

 

-6

 

Dulera

 

39

 

50

 

52

 

140

 

13

 

25

 

22

 

59

 

37

 

96

 

*

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Women’s Health & Endocrine

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fosamax

 

184

 

186

 

152

 

522

 

208

 

221

 

215

 

644

 

211

 

855

 

-29

 

-19

 

NuvaRing

 

146

 

157

 

156

 

459

 

142

 

154

 

159

 

455

 

168

 

623

 

-2

 

1

 

Follistim AQ

 

116

 

125

 

111

 

352

 

133

 

143

 

129

 

404

 

126

 

530

 

-14

 

-13

 

Implanon

 

76

 

85

 

93

 

254

 

60

 

81

 

80

 

220

 

74

 

294

 

16

 

15

 

Cerazette

 

67

 

72

 

64

 

202

 

59

 

66

 

74

 

199

 

69

 

268

 

-14

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Maxalt

 

156

 

154

 

166

 

476

 

173

 

131

 

156

 

460

 

178

 

639

 

7

 

3

 

Arcoxia

 

112

 

117

 

109

 

338

 

114

 

100

 

108

 

321

 

110

 

431

 

2

 

5

 

Avelox

 

73

 

44

 

30

 

146

 

106

 

61

 

59

 

227

 

95

 

322

 

-50

 

-35

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hospital and Specialty

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Immunology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remicade

 

519

 

518

 

490

 

1,527

 

753

 

842

 

561

 

2,156

 

511

 

2,667

 

-13

 

-29

 

Simponi

 

74

 

76

 

86

 

236

 

54

 

75

 

74

 

203

 

61

 

264

 

15

 

16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Infectious Disease

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Isentress

 

337

 

398

 

399

 

1,133

 

292

 

337

 

343

 

972

 

387

 

1,359

 

16

 

17

 

PegIntron

 

162

 

183

 

165

 

510

 

166

 

154

 

163

 

482

 

175

 

657

 

1

 

6

 

Cancidas

 

145

 

166

 

163

 

474

 

158

 

168

 

150

 

476

 

164

 

640

 

8

 

 

Victrelis

 

111

 

126

 

149

 

387

 

1

 

21

 

31

 

53

 

87

 

140

 

*

 

*

 

Invanz

 

101

 

110

 

118

 

329

 

87

 

103

 

107

 

296

 

110

 

406

 

10

 

11

 

Primaxin

 

88

 

104

 

109

 

301

 

136

 

136

 

124

 

397

 

119

 

515

 

-12

 

-24

 

Noxafil

 

59

 

66

 

66

 

191

 

55

 

56

 

61

 

171

 

59

 

230

 

9

 

12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Temodar

 

237

 

225

 

227

 

688

 

248

 

234

 

223

 

704

 

230

 

935

 

2

 

-2

 

Emend

 

102

 

145

 

111

 

358

 

87

 

120

 

98

 

305

 

114

 

419

 

12

 

17

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cosopt / Trusopt

 

124

 

105

 

102

 

331

 

114

 

122

 

124

 

360

 

117

 

477

 

-18

 

-8

 

Bridion

 

58

 

60

 

68

 

186

 

41

 

47

 

52

 

141

 

60

 

201

 

29

 

32

 

Integrilin

 

53

 

60

 

48

 

160

 

64

 

56

 

53

 

172

 

57

 

230

 

-9

 

-7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diversified Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cozaar / Hyzaar

 

336

 

337

 

295

 

969

 

426

 

406

 

404

 

1,236

 

427

 

1,663

 

-27

 

-22

 

Propecia

 

108

 

100

 

104

 

312

 

106

 

112

 

112

 

330

 

117

 

447

 

-7

 

-5

 

Zocor

 

103

 

96

 

86

 

285

 

127

 

107

 

110

 

345

 

111

 

456

 

-22

 

-17

 

Claritin Rx

 

87

 

48

 

47

 

181

 

120

 

65

 

55

 

240

 

74

 

314

 

-14

 

-25

 

Remeron

 

57

 

66

 

52

 

175

 

60

 

57

 

65

 

181

 

59

 

241

 

-19

 

-3

 

Proscar

 

51

 

55

 

55

 

160

 

60

 

53

 

58

 

171

 

52

 

223

 

-6

 

-6

 

Vasotec / Vaseretic

 

53

 

49

 

42

 

144

 

57

 

59

 

57

 

173

 

58

 

231

 

-27

 

-17

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gardasil

 

284

 

324

 

581

 

1,189

 

214

 

277

 

445

 

935

 

274

 

1,209

 

31

 

27

 

ProQuad, M-M-R II and Varivax

 

255

 

316

 

396

 

967

 

244

 

291

 

391

 

927

 

276

 

1,202

 

1

 

4

 

RotaTeq

 

142

 

142

 

150

 

433

 

125

 

148

 

184

 

457

 

195

 

651

 

-19

 

-5

 

Zostavax

 

76

 

148

 

202

 

426

 

24

 

122

 

108

 

254

 

78

 

332

 

87

 

68

 

Pneumovax

 

112

 

101

 

160

 

372

 

79

 

64

 

133

 

276

 

222

 

498

 

20

 

35

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Pharmaceutical (2)

 

1,013

 

985

 

1,023

 

3,031

 

892

 

1,064

 

1,015

 

2,975

 

1,064

 

4,038

 

1

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANIMAL HEALTH

 

821

 

865

 

815

 

2,501

 

758

 

802

 

826

 

2,385

 

868

 

3,253

 

-1

 

5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONSUMER CARE

 

554

 

552

 

451

 

1,557

 

517

 

541

 

421

 

1,479

 

361

 

1,840

 

7

 

5

 

Claritin OTC

 

169

 

145

 

118

 

432

 

167

 

134

 

118

 

419

 

92

 

511

 

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Revenues (3)

 

274

 

333

 

347

 

955

 

486

 

448

 

421

 

1,355

 

310

 

1,666

 

-17

 

-30

 

Astra

 

186

 

223

 

255

 

664

 

322

 

306

 

299

 

928

 

256

 

1,184

 

-15

 

-28

 

 

* 100% or greater

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 $60 million, $75 million, and $116 million for the first, second, and third quarters of 2012, respectively.  Other Vaccines sales included in Other Pharmaceutical were $54 million, $67 million, $100 million and $62 million for the first, second, third and fourth quarters of 2011, respectively.

(3) Other revenues are primarily comprised of alliance revenue, miscellaneous corporate revenues and third party manufacturing sales.