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EX-99.2 - EX-99.2 - Merck & Co., Inc.a12-17045_1ex99d2.htm

Exhibit 99.1

 

News Release

 

 

 

Media Contacts:

Ron Rogers

 

Investor Contacts:

Carol Ferguson

 

(908) 423-6449

 

 

(908) 423-4465

 

 

 

 

 

 

Steve Cragle

 

 

Alex Kelly

 

(908) 423-3461

 

 

(908) 423-5185

 

Merck Announces Second-Quarter 2012 Financial Results

 

·                  2012 Second-Quarter Non-GAAP EPS Increased 11 Percent Over Prior Year to $1.05, Excluding Certain Items; GAAP EPS of $0.58

 

·                  Worldwide Sales Up One Percent to $12.3 Billion, Five Percent Excluding Foreign Exchange; Pharmaceuticals, Animal Health and Consumer Care All Contributed to Growth

 

·                  Double-Digit Global Growth for JANUVIA, JANUMET, VICTRELIS, ISENTRESS, GARDASIL and ZOSTAVAX

 

·                  On Track for Six Major Filings in 2012-2013, Including Suvorexant and Odanacatib

 

·                  Reaffirmed 2012 Full-Year Non-GAAP EPS Target of $3.75 to $3.85, Excluding Certain Items; GAAP EPS Range of $2.04 to $2.30

 

WHITEHOUSE STATION, N.J., July 27, 2012 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2012.

 

 

$ in millions, except EPS amounts

 

Second
Quarter
2012

 

Second
Quarter
2011

 

Sales

 

$12,311

 

$12,151

 

GAAP EPS

 

0.58

 

0.65

 

Non-GAAP EPS that excludes items listed below1

 

1.05

 

0.95

 

GAAP Net Income2

 

1,793

 

2,024

 

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

 

3,227

 

2,950

 

 

Non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the second quarter of $1.05 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.

 

 

 

Second Quarter 2012

 

Second Quarter 2011

 

$ in millions, except EPS amounts

 

Net
Income2

 

EPS

 

Net
Income2

 

EPS

 

GAAP

 

$1,793

 

$0.58

 

$2,024

 

$0.65

 

Difference

 

1,434

 

0.47

3

926

 

0.30

3

Non-GAAP that excludes items listed below1

 

$3,227

 

$1.05

 

$2,950

 

$0.95

 

 

 

 

 

 

 

 

 

 

 

$ in millions

 

Second
Quarter
2012

 

Second
Quarter
2011

 

 

 

 

 

Acquisition-related costs4

 

$1,417

 

$1,440

 

 

 

 

 

Restructuring costs

 

289

 

816

 

 

 

 

 

Other

 

 

7

 

 

 

 

 

Net decrease (increase) in income before taxes

 

1,706

 

2,263

 

 

 

 

 

Income tax (benefit) expense5

 

(272

)

(1,337

)

 

 

 

 

Decrease (increase) in net income

 

$1,434

 

$926

 

 

 

 

 

 

“This quarter we delivered strong operational performance by focusing on growth and execution.  We achieved top- and bottom-line growth by advancing our core strategy and maintaining momentum across our businesses,” said Kenneth C. Frazier, chairman and chief executive officer of Merck.  “The company remains focused on translating cutting-edge science into medically important products.  We’re seeing significant progress in the pipeline this year, and we expect six major filings over the next 18 months, including suvorexant for insomnia and odanacatib for osteoporosis.  This focus on innovation and execution will drive long-term shareholder value.”

 

Select Revenue Highlights

 

Worldwide sales were $12.3 billion for the second quarter of 2012, an increase of 1 percent, or 5 percent excluding foreign exchange, compared with the second quarter of 2011.  Sales also were unfavorably impacted by the arbitration settlement agreement with Johnson & Johnson discussed below.

 

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       Includes an estimated income tax (benefit) expense on the reconciling items.  The second quarter of 2011 also includes the net favorable impact of approximately $700 million relating to the settlement of a federal income tax audit, as well as the favorable impact of certain foreign and state tax rate changes that resulted in a net $230 million reduction of deferred tax liabilities on intangibles established in purchase accounting.

 

Page 2



 

$ in millions

 

Second Quarter
2012

 

Second Quarter
2011

 

Change

 

Total Sales

 

$12,311

 

$12,151

 

1

%

Pharmaceutical

 

10,560

 

10,360

 

2

%

SINGULAIR

 

1,431

 

1,354

 

6

%

JANUVIA

 

1,058

 

779

 

36

%

ZETIA

 

632

 

592

 

7

%

REMICADE

 

518

 

842

 

-38

%

VYTORIN

 

445

 

459

 

-3

%

JANUMET

 

411

 

321

 

28

%

ISENTRESS

 

398

 

337

 

18

%

COZAAR/HYZAAR

 

337

 

406

 

-17

%

GARDASIL

 

324

 

277

 

17

%

PROQUAD, M-M-R II and VARIVAX

 

316

 

291

 

9

%

Animal Health

 

865

 

802

 

8

%

Consumer Care

 

552

 

541

 

2

%

Other Revenues

 

333

 

448

 

-26

%

 

Pharmaceutical Revenue Performance

 

Second-quarter pharmaceutical sales grew 2 percent to $10.6 billion, including a 3 percent negative impact due to foreign exchange.  Adjusting pharmaceutical sales in the second quarter of 2011 to exclude sales of REMICADE (infliximab) and SIMPONI (golimumab) from the territories transferred to Johnson & Johnson through the settlement agreement, pharmaceutical sales would have increased 5 percent in the second quarter of 2012.6  The revenue increases largely reflect strong sales growth for JANUVIA (sitagliptin), VICTRELIS (boceprevir), JANUMET (sitagliptin/metformin hydrochloride), SINGULAIR (montelukast sodium), ISENTRESS (raltegravir) and GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant].  These increases were partially offset by expected declines in sales of COZAAR (losartan potassium) and HYZAAR (losartan potassium and hydrochlorothiazide) as well as European austerity measures.

 

Sales from emerging markets accounted for approximately 18 percent of pharmaceutical sales in the second quarter.  Growth in the emerging markets is being driven by diversified brands and core products like JANUVIA, JANUMET and ISENTRESS.  China continues to be a key driver with 27 percent growth for the second quarter, including a 4 percent benefit from foreign exchange.

 


6

$ in millions

 

Second
Quarter
2012

 

Second
Quarter
2011

 

Change

 

Pharmaceutical sales as reported

 

$10,560

 

$10,360

 

2

%

Sales of REMICADE and SIMPONI in the territories transferred

 

 

(306

)

 

 

Pharmaceutical sales as adjusted

 

$10,560

 

$10,054

 

5

%

 

Page 3



 

Worldwide sales of the combined diabetes franchise of JANUVIA/JANUMET, medicines that help lower blood sugar levels in adults with type 2 diabetes, grew 33 percent to $1.5 billion in the second quarter of 2012 driven by growth in all regions.

 

Worldwide sales of SINGULAIR, a once-a-day oral medicine for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, grew 6 percent to $1.4 billion in the second quarter of 2012.  The patent for SINGULAIR will expire in the U.S. in Aug. 2012 and in major European markets in Feb. 2013.  The company expects a significant and rapid reduction in sales thereafter in those markets.  SINGULAIR will retain marketing exclusivity in Japan until 2016.

 

Sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, grew 2 percent to $1.1 billion in the second quarter driven by growth of ZETIA in the United States and VYTORIN outside of the United States.

 

Combined sales of REMICADE and SIMPONI, treatments for inflammatory diseases, declined 35 percent to $594 million for the second quarter of 2012.  In Europe, Russia and Turkey, where Merck retained exclusive marketing rights, the combined sales of REMICADE and SIMPONI declined 3 percent for the second quarter of 2012, but excluding the impact of foreign exchange grew 6 percent.  In July 2011, the company transferred exclusive marketing rights for REMICADE and SIMPONI to Johnson & Johnson in Canada, Central and South America, the Middle East, Africa and Asia Pacific.

 

ISENTRESS, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, grew 18 percent to $398 million in the second quarter driven by strong growth in the emerging markets and the United States.

 

Global sales of Merck’s antihypertensive medicines COZAAR and HYZAAR were down 17 percent to $337 million in the second quarter of 2012 due to the loss of marketing exclusivity in the United States and major European markets in 2010.

 

Sales recorded by Merck for GARDASIL, a vaccine to help prevent certain diseases caused by four types of human papillomavirus (HPV), increased 17 percent to $324 million for the quarter driven by vaccinations of males in the United States and the launch in Japan.

 

Sales of ZOSTAVAX (zoster vaccine live), a vaccine for the prevention of herpes zoster, grew 22 percent to $148 million in the quarter.  The company continues to increase its promotional efforts for ZOSTAVAX in the United States.

 

Sales of VICTRELIS, the company’s oral hepatitis C virus NS3/4A protease inhibitor, were $126 million in the quarter.  VICTRELIS is approved in 43 countries and has launched in 23 of those markets.

 

Page 4



 

Animal Health Revenue Performance

 

Animal Health sales totaled $865 million for the second quarter of 2012, an 8 percent increase over the second quarter of 2011, including a 6 percent negative impact due to foreign exchange.  Animal Health had strong performance in the United States and Asia Pacific, with growth led by increased sales of cattle and swine products.  The division’s products include pharmaceutical and vaccine products for the prevention, treatment and control of disease in all major farm and companion animal species.

 

Consumer Care Revenue Performance

 

Second-quarter global sales of Consumer Care were $552 million, an increase of 2 percent compared to the second quarter of 2011, including a 1 percent negative impact due to foreign exchange.  The sales increase was primarily due to MiraLAX, CLARITIN and COPPERTONE.

 

Other Revenue Performance

 

Other revenues – primarily comprised of alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales – declined 26 percent to $333 million.  The change was driven largely by lower revenue from AstraZeneca LP (AZLP) recorded by Merck, which declined 27 percent to $223 million, as well as by lower third-party manufacturing sales.

 

Second-Quarter Expense and Other Information

 

The costs detailed below totaled $9.7 billion on a GAAP basis during the second quarter of 2012 and include $1.7 billion of acquisition-related costs and restructuring costs.

 

 

 

Included in expenses for the period

 

$ in millions

 

GAAP

 

Acquisition-Related
Costs4

 

Restructuring
Costs

 

Non-GAAP1

 

Second Quarter 2012

 

 

 

 

 

 

 

 

 

Materials and production

 

$4,112

 

$1,226

 

$83

 

$2,803

 

Marketing and administrative

 

3,249

 

64

 

21

 

3,164

 

Research and development

 

2,165

 

127

 

41

 

1,997

 

Restructuring costs

 

144

 

 

144

 

 

 

 

 

 

 

 

 

 

 

 

Second Quarter 2011

 

 

 

 

 

 

 

 

 

Materials and production

 

$4,284

 

$1,344

 

$109

 

$2,831

 

Marketing and administrative

 

3,525

 

77

 

23

 

3,425

 

Research and development

 

1,936

 

19

 

16

 

1,901

 

Restructuring costs

 

668

 

 

668

 

 

 

Page 5



 

The gross margin was 66.6 percent for the second quarter of 2012 and 64.7 percent for the second quarter of 2011, reflecting 10.6 and 12.0 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 $3.2 billion in the second quarter of 2012, a decrease from $3.4 billion in the second quarter of 2011.  The decrease was primarily due to ongoing productivity measures.

 

Research and development (R&D) expenses, on a non-GAAP basis, were $2.0 billion in the second quarter of 2012, an increase from $1.9 billion in the second quarter of 2011.  The increase primarily reflects the $120 million upfront payment as part of the Endocyte Inc. transaction.

 

Equity income from affiliates was $142 million for the second quarter, which primarily reflects the performance of AZLP and Sanofi Pasteur MSD.

 

Other (income) expense, net was $103 million of expense in the second quarter of 2012, compared to $121 million of expense in the second quarter of 2011.

 

Key Developments

 

The company noted the following developments:

·                  Pivotal Phase III data were presented that showed suvorexant, an investigational treatment for insomnia, improved patients’ ability to fall asleep and stay asleep, achieving significance on 15 of 16 primary endpoints.  Merck anticipates filing regulatory applications for approval by the end of 2012;

·                  Primary efficacy outcomes were met in the Phase III trial of odanacatib, Merck’s investigational cathepsin-K inhibitor for osteoporosis, and Merck announced that the study is being concluded early.  Merck expects to file regulatory applications for approval in the United States and Europe in the first half of 2013 and Japan in the third quarter of 2013;

·                  Merck continued to advance plans for four additional major regulatory filings by end of 2013 including:  BRIDION (sugammadex), a neuromuscular blocker reversal agent; V503, a nine-valent vaccine for HPV; TREDAPTIVE (extended-release niacin/laropiprant), a novel candidate for multiple lipid parameters; and vintafolide, a small molecule drug conjugate for ovarian and other cancers (European Union filing);

·                  Merck previously announced in late March 2012 that the independent Data Safety Monitoring Board of the IMPROVE-IT study planned to review data from the study again in approximately nine months.  That review has been scheduled for March 2013, at which point nine months of additional data will have been adjudicated;

 

Page 6



 

·                  Five-year data were presented from the STARTMRK study, in which the regimen including ISENTRESS demonstrated better efficacy and long-term safety and tolerability versus the regimen including efavirenz; and

·                  Merck and AstraZeneca amended their option agreement related to AZLP.  As a result, AstraZeneca will not acquire Merck’s stake in AZLP in 2012 and has a new option to acquire Merck’s interest in June 2014.

 

Financial Targets

 

Merck continues to expect full-year 2012 non-GAAP EPS to be between $3.75 and $3.85 and the 2012 GAAP EPS range to be $2.04 to $2.30.  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 6 percent for the third quarter and more than 3 percent for the full year.

 

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

 

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

 

$2.04 to $2.30

 

Difference3

 

1.71 to 1.55

 

Non-GAAP EPS that excludes items listed below

 

$3.75 to $3.85

 

 

 

 

 

Acquisition-related costs4

 

$5,200 to $4,900

 

Restructuring costs

 

1,100 to 800

 

Net decrease (increase) in income before taxes

 

6,300 to 5,700

 

Estimated income tax (benefit) expense

 

(1,110) to (985)

 

Decrease (increase) in net income

 

$5,190 to $4,715

 

 

Total Employees

 

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

 

Earnings Conference Call

 

Investors are invited to a live audio webcast of Merck’s second-quarter earnings conference call today at 8:00 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

 

Page 7



 

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. 91089609.

 

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 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

 

 

 

 

 

2Q12

 

2Q11

 

% Change

 

YTD 2012

 

YTD 2011

 

% Change

 

Sales

 

 

$

12,311

 

 

 

$

12,151

 

 

1

%

 

 

$

24,041

 

 

 

$

23,732

 

 

1

%

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production (1)

 

 

4,112

 

 

 

4,284

 

 

-4

%

 

 

8,150

 

 

 

8,343

 

 

-2

%

 

Marketing and administrative (1) 

 

 

3,249

 

 

 

3,525

 

 

-8

%

 

 

6,322

 

 

 

6,689

 

 

-5

%

 

Research and development (1) 

 

 

2,165

 

 

 

1,936

 

 

12

%

 

 

4,026

 

 

 

4,094

 

 

-2

%

 

Restructuring costs (2) 

 

 

144

 

 

 

668

 

 

-78

%

 

 

363

 

 

 

654

 

 

-44

%

 

Equity income from affiliates (3)

 

 

(142

)

 

 

(55

)

 

*

 

 

 

(253

)

 

 

(193

)

 

31

%

 

Other (income) expense, net (1) / (4)

 

 

103

 

 

 

121

 

 

-15

%

 

 

247

 

 

 

744

 

 

-67

%

 

Income Before Taxes

 

 

2,680

 

 

 

1,672

 

 

60

%

 

 

5,186

 

 

 

3,401

 

 

52

%

 

Income Tax Provision (Benefit)

 

 

860

 

 

 

(382

)

 

 

 

 

 

1,599

 

 

 

276

 

 

 

 

 

Net Income

 

 

1,820

 

 

 

2,054

 

 

-11

%

 

 

3,587

 

 

 

3,125

 

 

15

%

 

Less: Net Income Attributable to Noncontrolling Interests

 

 

27

 

 

 

30

 

 

 

 

 

 

56

 

 

 

58

 

 

 

 

 

Net Income Attributable to Merck & Co., Inc.

 

 

$

1,793

 

 

 

$

2,024

 

 

-11

%

 

 

$

3,531

 

 

 

$

3,067

 

 

15

%

 

Earnings per Common Share Assuming Dilution (5)

 

 

$

0.58

 

 

 

$

0.65

 

 

-11

%

 

 

$

1.15

 

 

 

$

0.98

 

 

17

%

 

Average Shares Outstanding Assuming Dilution

 

 

3,072

 

 

 

3,110

 

 

 

 

 

 

3,074

 

 

 

3,106

 

 

 

 

 

Tax Rate (6)

 

 

32.1

%

 

 

-22.8

%

 

 

 

 

 

30.8

%

 

 

8.1

%

 

 

 

 

 

*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 first six 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 $1,792 million and $2,020 million for the second quarter of 2012 and 2011, respectively, and was $3,528 million and $3,059 million for the first six months of 2012 and 2011, respectively.

 

(6) The GAAP effective tax rates for the second quarter and first six months of 2012 were 32.1% and 30.8%, respectively.  Excluding the impact of the non-GAAP reconciling items detailed in the accompanying tables, the effective tax rates were 25.8% and 25.3% for the second quarter and first six months of 2012, respectively.  The GAAP effective tax rates for the second quarter and first six months of 2011 were (22.8)% and 8.1%, respectively.  Excluding the impact of the non-GAAP reconciling items detailed in the accompanying tables, the effective tax rates were 24.3% and 24.9% for the second quarter and first six months of 2011, respectively.

 



 

 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS

GAAP TO NON-GAAP RECONCILIATION

SECOND 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

 

$

12,311

 

 

 

 

 

$

 

$

12,311

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

4,112

 

1,226

 

83

 

1,309

 

2,803

 

 

 

 

 

 

 

 

 

 

 

 

 

Marketing and administrative

 

3,249

 

64

 

21

 

85

 

3,164

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

2,165

 

127

 

41

 

168

 

1,997

 

 

 

 

 

 

 

 

 

 

 

 

 

Restructuring costs

 

144

 

 

 

144

 

144

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity income from affiliates

 

(142

)

 

 

 

 

 

(142

)

 

 

 

 

 

 

 

 

 

 

 

 

Other (income) expense, net

 

103

 

 

 

 

 

 

103

 

 

 

 

 

 

 

 

 

 

 

 

 

Income Before Taxes

 

2,680

 

(1,417

)

(289

)

(1,706

)

4,386

 

 

 

 

 

 

 

 

 

 

 

 

 

Taxes on Income

 

860

 

 

 

 

 

(272

)(3)

1,132

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income

 

1,820

 

 

 

 

 

(1,434

)

3,254

 

 

 

 

 

 

 

 

 

 

 

 

 

Less: Net Income Attributable to Noncontrolling Interests

 

27

 

 

 

 

 

 

27

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income Attributable to Merck & Co., Inc.

 

$

1,793

 

 

 

 

 

$

(1,434

)

$

3,227

 

 

 

 

 

 

 

 

 

 

 

 

 

Earnings per Common Share Assuming Dilution

 

$

0.58

 

 

 

 

 

 

 

$

1.05

(4)

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

3,072

 

 

 

 

 

 

 

3,072

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax Rate

 

32.1

%

 

 

 

 

 

 

25.8

%

 

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 $3,226 million for the second quarter of 2012.

 



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS

GAAP TO NON-GAAP RECONCILIATION

SIX MONTHS ENDED JUNE 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

 

$

24,041

 

 

 

 

 

$

 

$

24,041

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

8,150

 

2,455

 

88

 

2,543

 

5,607

 

 

 

 

 

 

 

 

 

 

 

 

 

Marketing and administrative

 

6,322

 

115

 

45

 

160

 

6,162

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

4,026

 

136

 

86

 

222

 

3,804

 

 

 

 

 

 

 

 

 

 

 

 

 

Restructuring costs

 

363

 

 

 

363

 

363

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity income from affiliates

 

(253

)

 

 

 

 

 

(253

)

 

 

 

 

 

 

 

 

 

 

 

 

Other (income) expense, net

 

247

 

 

 

 

 

 

247

 

 

 

 

 

 

 

 

 

 

 

 

 

Income Before Taxes

 

5,186

 

(2,706

)

(582

)

(3,288

)

8,474

 

 

 

 

 

 

 

 

 

 

 

 

 

Taxes on Income

 

1,599

 

 

 

 

 

(548

)(3)

2,147

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income

 

3,587

 

 

 

 

 

(2,740

)

6,327

 

 

 

 

 

 

 

 

 

 

 

 

 

Less: Net Income Attributable to Noncontrolling Interests

 

56

 

 

 

 

 

 

56

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income Attributable to Merck & Co., Inc.

 

$

3,531

 

 

 

 

 

$

(2,740

)

$

6,271

 

 

 

 

 

 

 

 

 

 

 

 

 

Earnings per Common Share Assuming Dilution

 

$

1.15

 

 

 

 

 

 

 

$

2.04

(4)

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

3,074

 

 

 

 

 

 

 

3,074

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax Rate

 

30.8

%

 

 

 

 

 

 

25.3

%

 

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.

 

(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 $6,266 million for the first six months of 2012.

 



 

MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)

Table 3

 

 

 

2012

 

2011

 

% Change

 

% Change

 

 

 

1Q

 

2Q

 

Jun YTD

 

1Q

 

2Q

 

Jun YTD

 

3Q

 

4Q

 

Full Year

 

2Q

 

Jun YTD

 

TOTAL SALES (1)

 

$11,731

 

$12,311

 

$24,041

 

$11,580

 

$12,151

 

$23,732

 

$12,022

 

$12,294

 

$48,047

 

1

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PHARMACEUTICAL

 

10,082

 

10,560

 

20,642

 

9,820

 

10,360

 

20,179

 

10,354

 

10,755

 

41,289

 

2

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Primary Care and Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

614

 

632

 

1,246

 

582

 

592

 

1,174

 

614

 

640

 

2,428

 

7

 

6

 

Vytorin

 

444

 

445

 

889

 

480

 

459

 

939

 

469

 

475

 

1,882

 

-3

 

-5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diabetes & Obesity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Januvia

 

919

 

1,058

 

1,977

 

739

 

779

 

1,518

 

846

 

960

 

3,324

 

36

 

30

 

Janumet

 

392

 

411

 

802

 

305

 

321

 

626

 

350

 

386

 

1,363

 

28

 

28

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

1,340

 

1,431

 

2,771

 

1,328

 

1,354

 

2,682

 

1,336

 

1,461

 

5,479

 

6

 

3

 

Nasonex

 

375

 

293

 

668

 

373

 

323

 

696

 

266

 

325

 

1,286

 

-9

 

-4

 

Clarinex

 

134

 

140

 

273

 

155

 

209

 

364

 

128

 

129

 

621

 

-33

 

-25

 

Asmanex

 

48

 

51

 

99

 

60

 

47

 

107

 

42

 

57

 

206

 

8

 

-8

 

Dulera

 

39

 

50

 

89

 

13

 

25

 

37

 

22

 

37

 

96

 

*

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Women’s Health & Endocrine

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fosamax

 

184

 

186

 

370

 

208

 

221

 

429

 

215

 

211

 

855

 

-16

 

-14

 

NuvaRing

 

146

 

157

 

303

 

142

 

154

 

297

 

159

 

168

 

623

 

2

 

2

 

Follistim AQ

 

116

 

125

 

241

 

133

 

143

 

276

 

129

 

126

 

530

 

-12

 

-13

 

Implanon

 

76

 

85

 

161

 

60

 

81

 

141

 

80

 

74

 

294

 

5

 

14

 

Cerazette

 

67

 

72

 

139

 

59

 

66

 

125

 

74

 

69

 

268

 

9

 

11

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Maxalt

 

156

 

154

 

310

 

173

 

131

 

304

 

156

 

178

 

639

 

17

 

2

 

Arcoxia

 

112

 

117

 

229

 

114

 

100

 

214

 

108

 

110

 

431

 

17

 

7

 

Avelox

 

73

 

44

 

117

 

106

 

61

 

167

 

59

 

95

 

322

 

-28

 

-30

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hospital and Specialty

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Immunology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remicade

 

519

 

518

 

1,037

 

753

 

842

 

1,595

 

561

 

511

 

2,667

 

-38

 

-35

 

Simponi

 

74

 

76

 

150

 

54

 

75

 

129

 

74

 

61

 

264

 

1

 

16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Infectious Disease

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Isentress

 

337

 

398

 

735

 

292

 

337

 

629

 

343

 

387

 

1,359

 

18

 

17

 

PegIntron

 

162

 

183

 

345

 

166

 

154

 

319

 

163

 

175

 

657

 

19

 

8

 

Cancidas

 

145

 

166

 

311

 

158

 

168

 

326

 

150

 

164

 

640

 

-1

 

-4

 

Victrelis

 

111

 

126

 

238

 

1

 

21

 

22

 

31

 

87

 

140

 

*

 

*

 

Invanz

 

101

 

110

 

211

 

87

 

103

 

189

 

107

 

110

 

406

 

7

 

12

 

Primaxin

 

88

 

104

 

192

 

136

 

136

 

272

 

124

 

119

 

515

 

-24

 

-30

 

Noxafil

 

59

 

66

 

125

 

55

 

56

 

110

 

61

 

59

 

230

 

19

 

13

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Temodar

 

237

 

225

 

461

 

248

 

234

 

481

 

223

 

230

 

935

 

-4

 

-4

 

Emend

 

102

 

145

 

247

 

87

 

120

 

207

 

98

 

114

 

419

 

21

 

19

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cosopt / Trusopt

 

124

 

105

 

229

 

114

 

122

 

236

 

124

 

117

 

477

 

-14

 

-3

 

Bridion

 

58

 

60

 

118

 

41

 

47

 

89

 

52

 

60

 

201

 

27

 

33

 

Integrilin

 

53

 

60

 

113

 

64

 

56

 

120

 

53

 

57

 

230

 

7

 

-6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diversified Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cozaar / Hyzaar

 

336

 

337

 

674

 

426

 

406

 

832

 

404

 

427

 

1,663

 

-17

 

-19

 

Propecia

 

108

 

100

 

208

 

106

 

112

 

218

 

112

 

117

 

447

 

-11

 

-5

 

Zocor

 

103

 

96

 

199

 

127

 

107

 

234

 

110

 

111

 

456

 

-10

 

-15

 

Claritin Rx

 

87

 

48

 

134

 

120

 

65

 

186

 

55

 

74

 

314

 

-27

 

-28

 

Remeron

 

57

 

66

 

123

 

60

 

57

 

117

 

65

 

59

 

241

 

16

 

5

 

Proscar

 

51

 

55

 

106

 

60

 

53

 

113

 

58

 

52

 

223

 

4

 

-6

 

Vasotec / Vaseretic

 

53

 

49

 

102

 

57

 

59

 

116

 

57

 

58

 

231

 

-18

 

-12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gardasil

 

284

 

324

 

608

 

214

 

277

 

490

 

445

 

274

 

1,209

 

17

 

24

 

ProQuad, M-M-R II and Varivax

 

255

 

316

 

571

 

244

 

291

 

535

 

391

 

276

 

1,202

 

9

 

7

 

RotaTeq

 

142

 

142

 

284

 

125

 

148

 

272

 

184

 

195

 

651

 

-4

 

4

 

Zostavax

 

76

 

148

 

224

 

24

 

122

 

146

 

108

 

78

 

332

 

22

 

54

 

Pneumovax

 

112

 

101

 

213

 

79

 

64

 

143

 

133

 

222

 

498

 

57

 

49

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Pharmaceutical (2)

 

1,013

 

985

 

2,000

 

892

 

1,064

 

1,957

 

1,018

 

1,064

 

4,038

 

-7

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANIMAL HEALTH

 

821

 

865

 

1,686

 

758

 

802

 

1,560

 

826

 

868

 

3,253

 

8

 

8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONSUMER CARE

 

554

 

552

 

1,106

 

517

 

541

 

1,058

 

421

 

361

 

1,840

 

2

 

5

 

Claritin OTC

 

169

 

145

 

314

 

167

 

134

 

301

 

118

 

92

 

511

 

8

 

4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Revenues (3)

 

274

 

333

 

608

 

486

 

448

 

935

 

421

 

310

 

1,666

 

-26

 

-35

 

Astra

 

186

 

223

 

409

 

322

 

306

 

628

 

299

 

256

 

1,184

 

-27

 

-35

 

 

*

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 and $75 million for the first and second 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.