0001193125-11-116837.txt : 20110429 0001193125-11-116837.hdr.sgml : 20110429 20110429073240 ACCESSION NUMBER: 0001193125-11-116837 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20110426 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110429 DATE AS OF CHANGE: 20110429 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Merck & Co. Inc. CENTRAL INDEX KEY: 0000310158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221918501 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-06571 FILM NUMBER: 11790923 BUSINESS ADDRESS: STREET 1: ONE MERCK DRIVE STREET 2: P.O. BOX 100 CITY: WHITEHOUSE STATION STATE: NJ ZIP: 08889-0100 BUSINESS PHONE: 908-423-4840 MAIL ADDRESS: STREET 1: ONE MERCK DRIVE STREET 2: P.O. BOX 100 CITY: WHITEHOUSE STATION STATE: NJ ZIP: 08889-0100 FORMER COMPANY: FORMER CONFORMED NAME: SCHERING PLOUGH CORP DATE OF NAME CHANGE: 19920703 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) April 26, 2011

 

 

Merck & Co., Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

 

New Jersey

(State or Other Jurisdiction of Incorporation)

 

1-6571   22-1918501

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

One Merck Drive, PO Box 100, Whitehouse Station, NJ   08889-0100
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code (908) 423-1000

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

The following information, including the exhibits hereto, is being furnished pursuant to this Item 2.02.

Incorporated by reference is a press release issued by the Registrant on April 29, 2011, regarding earnings for the first quarter of 2011, attached as Exhibit 99.1. Also incorporated by reference is certain supplemental information not included in the press release, attached as Exhibit 99.2.

Item 8.01. Other Events.

The following information, including the exhibit hereto, is being furnished pursuant to this Item 8.01.

Incorporated by reference is a press release issued by the Registrant on April 27, 2011, regarding Registrant’s announcement of the approval by its Board of Directors of a new $5 billion treasury stock purchase program. The press release is attached as Exhibit 99.3.

This information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and is not incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit 99.1    Press release issued April 29, 2011 regarding earnings for first quarter 2011
Exhibit 99.2    Certain supplemental information not included in the press release
Exhibit 99.3    Press release issued April 27, 2011 regarding a $5 billion share repurchase program


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

        Merck & Co., Inc.
Date: April 29, 2011     By:  

/s/ Katie E. Fedosz

      Katie E. Fedosz
      Senior Assistant Secretary


EXHIBIT INDEX

 

Exhibit

Number

  

Description

99.1    Press release issued April 29, 2011 regarding earnings for first quarter 2011
99.2    Certain supplemental information not included in the press release
99.3    Press release issued April 27, 2011 regarding a $5 billion share repurchase program
EX-99.1 2 dex991.htm PRESS RELEASE ISSUED APRIL 29, 2011 REGARDING EARNINGS FOR FIRST QUARTER 2011 Press release issued April 29, 2011 regarding earnings for first quarter 2011

Exhibit 99.1

 

LOGO

 

  

News Release

 

 

 

Media Contacts:    Steven Campanini    Investor Contacts:    Carol Ferguson
   (908) 423-4291       (908) 423-4465
   David Caouette       Joe Romanelli
   (908) 423-3461       (908) 423-5088

Merck Announces First Quarter 2011 Financial Results

 

   

Double-Digit EPS Growth in First Quarter 2011: Non-GAAP EPS of $0.92; GAAP EPS of $0.34

 

   

Double-Digit Global Growth for JANUVIA, JANUMET, SINGULAIR, REMICADE, NASONEX and ISENTRESS; Key Product Launches Underway

 

   

Pharmaceutical, Animal Health and Consumer Care Divisions All Contributed Solid Revenue Growth

 

   

Company Updates Full-Year 2011 EPS Targets: Non-GAAP EPS Range of $3.66 to $3.76; GAAP EPS Range of $2.04 to $2.39

WHITEHOUSE STATION, N.J., April 29, 2011 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2011.

 

$ in millions, except EPS amounts

   First
Quarter
2011
     First
Quarter
2010
 

Sales

   $ 11,580       $ 11,422   

GAAP EPS

     0.34         0.09   

Non-GAAP EPS that excludes items listed below 1

     0.92         0.83   

GAAP Net Income 2

     1,043         299   

Non-GAAP Net Income that excludes items listed below 1, 2

     2,861         2,608   

 

1 

Merck is providing certain 2011 and 2010 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.


Non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the first quarter of $0.92 excludes purchase accounting adjustments, restructuring costs, merger-related expenses, a $500 million charge related to the resolution of the arbitration proceeding with Johnson & Johnson, and certain other items.

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

 

     First
Quarter
2011
    First
Quarter
2010
 

$ in millions, except EPS amounts

   Net
Income 2
     EPS     Net
Income 2
     EPS  

GAAP

   $ 1,043       $ 0.34      $ 299       $ 0.09   

Difference

     1,818         0.58 3      2,309         0.74 3 

Non-GAAP that excludes items listed below

   $ 2,861       $ 0.92      $ 2,608       $ 0.83   

 

$ in millions

   First
Quarter
2011
    First
Quarter
2010
 

Purchase accounting adjustments 4

   $ 1,580      $ 2,374   

Costs related to restructuring programs

     126        351   

Merger-related costs

     77        87   

Arbitration settlement charge

     500        —     

Other 5

     (134     —     

Net decrease (increase) in income before taxes

     2,149        2,812   

Estimated income tax (benefit) expense 6

     (331     (503

Decrease (increase) in net income

   $ 1,818      $ 2,309   

“Merck’s first quarter performance underscores that we are successfully delivering on our intent to grow both the top line and the bottom line,” said Kenneth C. Frazier, president and chief executive officer. “Our strong results were largely driven by double-digit growth of key products combined with deliberate cost control measures across all areas of the company as we continue to create a more effective and efficient operating model.

“It is clear that Merck’s business momentum is building, and we continue to demonstrate the ongoing value of the merger. We’re making progress in our robust late-stage pipeline, and leveraging the benefits of our expanded pharmaceutical and vaccine, animal health and consumer portfolio.”

 

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 

Amounts for the first quarter of 2011 and 2010 reflect $302 million and $27 million, respectively, of in-process research and development impairment charges. The remaining amounts represent expenses for the amortization of intangible assets and amortization of purchase accounting adjustments to inventories recognized as a result of the merger.

5 

Represents a gain on the sale of certain manufacturing facilities and related assets reflected in other (income) expense, net.

6 

Includes an estimated income tax (benefit) expense on the reconciling items. In addition, amount for the first quarter of 2010 includes a $147 million tax charge related to U.S. healthcare reform legislation.

 

Page 2


Select Revenue Highlights

Worldwide sales were $11.6 billion for the first quarter of 2011, an increase of 1 percent compared with the first quarter of 2010. The revenue increase largely reflects strong sales of JANUVIA, JANUMET, SINGULAIR, REMICADE, NASONEX and ISENTRESS, partially offset by lower sales of COZAAR 7 and HYZAAR 7. In the first quarter of 2011, 18 percent of pharmaceutical sales were from emerging markets.

The table below reflects sales of the company’s top Pharmaceutical products, as well as total sales of Animal Health and Consumer Care products.

 

$ in millions

   First
Quarter
2011
     First
Quarter
2010
     Change  

Total Sales

   $ 11,580       $ 11,422         1
                          

Pharmaceutical 8

     9,820         9,665         2

SINGULAIR

     1,328         1,165         14

REMICADE

     753         674         12

JANUVIA

     739         511         45

ZETIA

     582         534         9

VYTORIN

     480         477         1

COZAAR/HYZAAR

     426         782         -46

NASONEX

     373         320         17

JANUMET

     305         201         52

ISENTRESS

     292         232         26

TEMODAR

     248         274         -10

GARDASIL

     214         233         -8

Animal Health

     758         709         7

Consumer Care 8

     517         489         6

Other Revenues 9

     486         559         -13

The combined diabetes franchise for JANUVIA (sitagliptin)/JANUMET (sitagliptin/metformin hydrochloride) continued its strong performance across all geographic regions during the first quarter of 2011, reaching quarterly combined sales of more than $1 billion for the first time – a 47 percent increase compared to the same period last year.

Worldwide sales of SINGULAIR (montelukast sodium), a once-a-day oral medicine indicated for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, grew 14 percent from the first quarter of 2010 to $1.3 billion, driven by gains in the United States, emerging markets and Japan.

 

7 

COZAAR and HYZAAR are registered trademarks of E.I. duPont de Nemours and Company, Wilmington, Del.

8 

In the first quarter of 2011, Merck changed the reporting for certain over-the-counter products. Sales of these products outside the United States were previously recorded in the Pharmaceutical business, and are now reported in the Consumer Care business. Prior period amounts have been recast on a comparative basis.

9 

Other revenues are primarily comprised of alliance revenue, miscellaneous corporate revenues and third party manufacturing sales. Revenue from AstraZeneca LP recorded by Merck was $322 million in the first quarter of 2011.

 

Page 3


Global sales grew in the quarter for REMICADE (infliximab), a treatment for inflammatory diseases, led by increases in gastrointestinal indications for the treatment of ulcerative colitis and Crohn’s disease as well as emerging market gains.

ISENTRESS (raltegravir), an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, continued strong growth in the quarter driven by demand in the United States and Europe.

As expected, global sales of Merck’s antihypertensive medicines COZAAR (losartan potassium) and HYZAAR (losartan potassium and hydrochlorothiazide) continue to decline following loss of marketing exclusivity for these products in the United States and in major European markets. Sales of TEMODAR (temozolomide), a treatment for certain types of brain tumors, declined due to generic competition in Europe.

Sales of ZOSTAVAX (zoster vaccine live) declined due to continued intermittent supply issues.

Product Performance – Animal Health

The company drove solid first-quarter performance in the Animal Health business across all regions, with a 7 percent sales increase over the same period last year. The growth was led by increased sales of cattle, swine and aquaculture 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. In addition, in March of 2011, Merck and sanofi-aventis announced the termination of their agreement to form a new animal health joint venture.

Product Performance – Consumer Care

Merck Consumer Care delivered a first-quarter sales increase of 6 percent compared to the first quarter of 2010, with strong performance across several key brands including CLARITIN and COPPERTONE. Consumer Care includes footcare and suncare consumer products, and a variety of over-the-counter medicines.

First Quarter Expense and Other Information

The costs detailed below on a GAAP basis during the first quarter of 2011 totaled $9.4 billion and include $1.8 billion of purchase accounting adjustments, restructuring costs and merger-related costs.

 

Page 4


           Included in expenses for the period         

$ in millions

 

First Quarter 2011

   GAAP     Purchase
Accounting
Adjustments4
     Restructuring
Costs
    Merger-
Related

Costs
     Non-GAAP1  

Materials and production

   $ 4,059      $ 1,278       $ 72      $ 19       $ 2,690   

Marketing and administrative

     3,164        —           23        58         3,083   

Research and development

     2,158        302         45        —           1,811   

Restructuring costs

     (14     —           (14     —           —     

First Quarter 2010

                                

Materials and production

   $ 5,216      $ 2,347       $ 57      $ —         $ 2,812   

Marketing and administrative

     3,222        —           —          80         3,142   

Research and development

     2,051        27         6        —           2,018   

Restructuring costs

     288        —           288        —           —     

The gross margin was 64.9 percent for the first quarter of 2011 and 54.3 percent for the first quarter of 2010, reflecting 11.9 and 21.1 percentage point unfavorable impacts, respectively, from the purchase accounting adjustments, restructuring and merger-related costs noted above.

Equity income from affiliates was $138 million in the first quarter. Equity income from affiliates primarily includes the AstraZeneca LP, Johnson & Johnson Merck Consumer Pharmaceuticals Company and Sanofi Pasteur MSD partnerships.

Other (income) expense, net was $622 million of expense in the first quarter of 2011 which includes a $500 million charge related to the resolution of the arbitration proceeding with Johnson & Johnson. Other (income) expense, net for the first quarter of 2010 was $167 million of expense.

The GAAP effective tax rate was 38.1 percent for the first quarter of 2011. The non-GAAP effective tax rate, which excludes the impact of purchase accounting adjustments, restructuring costs, merger-related expenses, a $500 million charge related to the resolution of the arbitration proceeding, and certain other items, was 25.5 percent for the quarter.

Key Developments

 

   

Merck reached an agreement with Johnson & Johnson that settles the arbitration proceeding about the distribution rights for REMICADE (infliximab) and SIMPONI (golimumab).

 

   

Merck now has five investigational medicines under regulatory review in the United States and European Union (EU), including two that were accepted for review in the first quarter of 2011.

 

Page 5


  - VICTRELIS (boceprevir), the company’s investigational oral hepatitis C protease inhibitor currently under Priority Review status by the U.S. Food and Drug Administration (FDA) and accelerated assessment status by the EU, was recommended for approval by unanimous vote by the FDA’s Antiviral Drugs Advisory Committee on April 27, 2011.

 

  - An investigational extended-release formulation of JANUMET (sitagliptin/metformin HCI) for Type 2 diabetes is under standard review by the FDA.

 

  - The FDA accepted for standard review during the first quarter of 2011 a combination of JANUVIA (sitagliptin) and ZOCOR (simvastatin) for the investigational treatment of diabetes and dyslipidemia.

 

  - Tafluprost, an investigational prostaglandin analogue ophthalmic solution, was accepted for standard review by the FDA in the first quarter of 2011.

 

  - NOMAC-E2 (acetate 2.5 mg /17ß-estradiol 1.5 mg), an investigational monophasic combined oral contraceptive tablet for the use by women to prevent pregnancy was recommended for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

 

   

Two medicines received regulatory approval for expanded indications.

 

  - In the United States, ZOSTAVAX (Zoster Vaccine Live) received an expanded age indication for the prevention of herpes zoster, commonly known as shingles, to include adults 50 to 59 years of age, and

 

  - In the EU, SIMPONI (golimumab) received approval for use in combination with methotrexate in certain adults with severe, active and progressive rheumatoid arthritis for the reduction in the rate of progression of joint damage as measured by X-ray.

 

   

In the United States, the FDA approved SYLATRON (peginterferon alfa-2b) for the adjuvant treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

 

   

The company formed a new joint venture with Sun Pharmaceutical Industries Ltd., a leading Indian multinational pharmaceutical company, to develop, manufacture and commercialize new combinations and formulations of innovative, branded generics for the emerging markets.

 

   

Merck agreed to acquire Inspire Pharmaceuticals, Inc., a specialty pharmaceutical company, for approximately $430 million to expand and position its ophthalmology portfolio for future growth. The transaction is expected to close in the second quarter of 2011.

 

Page 6


Financial Targets

The company updated its 2011 non-GAAP EPS target range to $3.66 to $3.76 from the previous target range of $3.64 to $3.76. The target range excludes purchase accounting adjustments, restructuring costs, merger-related expenses, the $500 million charge related to the resolution of the arbitration proceeding with Johnson & Johnson, and certain other items. The 2011 GAAP EPS target range is $2.04 to $2.39.

In addition, the company lowered its non-GAAP R&D expense target to a range of $8.0 billion to $8.4 billion for the full year of 2011. This target excludes restructuring costs and in-process R&D impairment charges.

Merck continues to expect full year 2011 revenue to grow in the low- to mid-single digit percent range from a base of $46.0 billion in 2010.

Merck continues to estimate that its consolidated non-GAAP 2011 tax rate will be approximately 20 percent to 22 percent.

A reconciliation of anticipated 2011 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 2011

GAAP EPS

   $2.04 to $2.39

EPS difference 3

   1.62 to 1.37

Non-GAAP EPS that excludes items listed below

   $3.66 to $3.76

 

Purchase accounting adjustments 4

   $5,400 to $5,100

Costs related to restructuring programs

   900 to 700

Merger-related costs

   200 to 100

Arbitration settlement charge

   500

Other 5

   (134)

Net decrease (increase) in income before taxes

   6,866 to 6,266

Estimated income tax (benefit) expense 10

   (1,840) to (2,000)

Decrease (increase) in net income

   $5,026 to $4,266

Total Employees

As of March 31, 2011, Merck had approximately 93,000 employees worldwide.

Earnings Conference Call

Investors are invited to a live audio webcast of Merck’s first quarter earnings conference call today at 8:00 a.m. EDT by visiting Merck’s Web 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

 

10 

Includes an estimated income tax (benefit) expense on the reconciling items as well as a range of estimated tax benefits expected to be recorded in the second quarter as a result of the conclusion of federal tax audits.

 

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 (706) 645-9291 or (800) 642-1687 and enter ID No. 51049889.

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.

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 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; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally 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 2010 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     % Change  
     1Q11     1Q10    

Sales

   $ 11,580      $ 11,422        1

Costs, Expenses and Other

      

Materials and production (1)

     4,059        5,216        -22

Marketing and administrative (1) / (2)

     3,164        3,222        -2

Research and development (1) / (2)

     2,158        2,051        5

Restructuring costs (3)

     (14     288        *   

Equity income from affiliates (4)

     (138     (138     —     

Other (income) expense, net (1) / (5)

     622        167        *   

Income Before Taxes

     1,729        616        *   

Income Tax Provision

     658        286     

Net Income

     1,071        330        *   

Less: Net Income Attributable to Noncontrolling Interests

     28        31     

Net Income Attributable to Merck & Co., Inc.

   $ 1,043      $ 299        *   

Earnings per Common Share Assuming Dilution (6)

   $ 0.34      $ 0.09        *   

Average Shares Outstanding Assuming Dilution

     3,104        3,141     

Tax Rate (7)

     38.1     46.4  

*³ 100%

 

(1) Amounts include the impact of purchase accounting adjustments, restructuring costs, merger-related costs and certain other items. See accompanying tables for details.
(2) The first quarter of 2010 includes a $24 million reclassification of certain expenses from marketing and administrative to research and development.
(3) Represents separation and other related costs associated with restructuring activities.
(4) Primarily reflects equity income from AstraZeneca LP, Johnson & JohnsonºMerck Consumer Pharmaceuticals Company and Sanofi Pasteur MSD partnerships.
(5) Other (income) expense, net in the first quarter of 2011 includes a charge of $500 million related to the resolution of the arbitration proceeding with Johnson & Johnson and a $134 million gain on the sale of certain manufacturing facilities and related assets. Other (income) expense, net in the first quarter of 2010 includes $102 million of income on the settlement of certain disputed royalties and $80 million of exchange losses due to a Venezuelan currency devaluation.
(6) 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 $1,040 million and $298 million for the first quarter of 2011 and 2010, respectively.
(7) The GAAP effective tax rate for the first quarter of 2011 was 38.1%. Excluding the impact of the non-GAAP items detailed in the accompanying table, the effective tax rate was 25.5% for the first quarter of 2011. The GAAP effective tax rate for the first quarter of 2010 was 46.4%. Excluding the impact of the non-GAAP items detailed in the accompanying table, the effective tax rate was 23.0% for the first quarter of 2010.


MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS

GAAP TO NON-GAAP RECONCILIATION

FIRST QUARTER 2011

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2a

 

     GAAP     Purchase
Accounting  (1)
    Restructuring
Costs (2)
    Merger-Related
Costs (3)
    Certain Other
Items (4)
    Adjustment
Subtotal
    Non-GAAP  

Sales

   $ 11,580              $ —        $ 11,580   

Materials and production

     4,059        1,278        72        19          1,369        2,690   

Marketing and administrative

     3,164          23        58          81        3,083   

Research and development

     2,158        302        45            347        1,811   

Restructuring costs

     (14       (14         (14     —     

Equity income from affiliates

     (138             —          (138

Other (income) expense, net

     622              366        366        256   

Income Before Taxes

     1,729        (1,580     (126     (77     (366     (2,149     3,878   

Taxes on Income

     658                (331 (5)      989   

Net Income

     1,071                (1,818     2,889   

Less: Net Income Attributable to Noncontrolling Interests

     28                —          28   

Net Income Attributable to Merck & Co., Inc.

   $ 1,043              $ (1,818   $ 2,861   

Earnings per Common Share Assuming Dilution

   $ 0.34                $ 0.92  (6) 

Average Shares Outstanding Assuming Dilution

     3,104                  3,104   

Tax Rate

     38.1               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 for the amortization of intangible assets and the amortization of purchase accounting adjustments to inventories recognized as a result of the merger. 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.
(3) Merger-related costs include integration costs associated with the merger.
(4) Included in other (income) expense, net is a $500 million charge related to the resolution of the arbitration proceeding with Johnson & Johnson and a $134 million gain on the sale of certain manufacturing facilities and related assets.
(5) Represents the estimated tax impact on the reconciling items.
(6) 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 $2,853 million for the first quarter of 2011.


MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

FIRST QUARTER 2011

(AMOUNTS IN MILLIONS)

Table 3

 

     2011      2010      % Change  
     1Q      1Q      2Q      3Q      4Q      Full Year      1Q  

TOTAL SALES (1)

   $ 11,580       $ 11,422       $ 11,346       $ 11,125       $ 12,094       $ 45,987         1   
                                                              

PHARMACEUTICAL (2)

     9,820         9,665         9,638         9,523         10,441         39,267         2   

Cardiovascular

                    

Zetia

     582         534         564         571         629         2,297         9   

Vytorin

     480         477         490         485         562         2,014         1   

Integrilin

     64         70         70         63         63         266         -9   

Diabetes & Obesity

                    

Januvia

     739         511         600         600         675         2,385         45   

Janumet

     305         201         218         247         288         954         52   

Diversified Brands

                    

Cozaar / Hyzaar

     426         782         485         423         415         2,104         -46   

Zocor

     127         116         117         114         121         468         10   

Claritin Rx

     120         98         58         53         86         296         23   

Propecia

     106         100         113         109         124         447         7   

Proscar

     60         58         56         58         44         216         3   

Remeron

     60         51         59         50         62         223         18   

Vasotec / Vaseretic

     57         59         63         69         64         255         -4   

Infectious Disease

                    

Isentress

     292         232         267         278         313         1,090         26   

PegIntron

     166         186         185         168         198         737         -11   

Cancidas

     158         153         150         135         174         611         3   

Primaxin

     136         159         158         135         158         610         -14   

Avelox

     106         106         59         59         92         316         1   

Invanz

     87         75         83         91         113         362         16   

Noxafil

     55         49         50         52         48         198         12   

Rebetol

     53         56         55         55         54         221         -7   

Crixivan / Stocrin

     45         52         48         49         58         206         -13   

Neurosciences & Ophthalmology

                    

Maxalt

     173         135         133         133         149         550         29   

Cosopt / Trusopt

     114         115         123         114         131         484         -1   

Oncology

                    

Temodar

     248         274         271         254         266         1,065         -10   

Emend

     87         84         93         91         110         378         4   

Intron A

     49         54         51         50         54         209         -11   

Respiratory & Immunology

                    

Singulair

     1,328         1,165         1,258         1,215         1,349         4,987         14   

Remicade

     753         674         669         661         710         2,714         12   

Nasonex

     373         320         338         259         303         1,219         17   

Clarinex

     155         164         191         131         138         623         -5   

Arcoxia

     114         95         95         94         115         398         19   

Asmanex

     60         51         56         48         53         208         17   

Simponi

     54         10         18         27         42         97         *   

Proventil

     42         57         55         43         55         210         -26   

Dulera

     13         0         0         2         6         8         *   

Vaccines

                    

ProQuad, M-M-R II and Varivax

     244         319         340         434         285         1,378         -23   

Gardasil

     214         233         219         316         221         988         -8   

RotaTeq

     125         93         139         119         169         519         35   

Pneumovax

     79         51         59         110         156         376         55   

Zostavax

     24         95         18         23         107         243         -74   

Women’s Health & Endocrine

                    

Fosamax

     208         230         241         220         234         926         -10   

NuvaRing

     142         135         145         134         145         559         5   

Follistim AQ

     133         134         137         119         138         528         —     

Implanon

     60         51         51         64         71         236         18   

Cerazette

     59         55         49         56         49         209         7   

Other Pharmaceutical (3)

     745         946         941         942         1,044         3,879         -21   

ANIMAL HEALTH

     758         709         731         687         815         2,941         7   

CONSUMER CARE (2)

     517         489         544         409         381         1,823         6   

Claritin OTC

     167         136         167         120         103         526         22   

Other Revenues (4)

     486         559         433         506         457         1,956         -13   

Astra

     322         364         241         345         302         1,252         -11   

 

* 100% or over

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

 

(1)

Only select products are shown.

(2)

In the first quarter of 2011, Merck changed the reporting for certain over -the-counter products. Sales of these products outside the United States were previously recorded in the Pharmaceutical business, and are now reported in the Consumer Care business. Prior period amounts have been recast on a comparative basis.

(3) 

Includes pharmaceutical products not individually shown above. Other vaccines sales included in Other Pharmaceutical were $54 million for the first quarter of 2011. Other vaccines sales included in Other Pharmaceutical were $55 million, $57 million, $94 million and $75 million for the first, second, third and fourth quarters of 2010, respectively.

(4)

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

EX-99.2 3 dex992.htm CERTAIN SUPPLEMENTAL INFORMATION NOT INCLUDED IN THE PRESS RELEASE Certain supplemental information not included in the press release

Exhibit 99.2

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1a

 

     2011     2010     % Change  
     1Q     1Q     2Q     3Q     4Q     Full Year     1Q  

Sales

   $ 11,580      $ 11,422      $ 11,346      $ 11,125      $ 12,094      $ 45,987        1

Costs, Expenses and Other

              

Materials and production

     4,059        5,216        4,549        4,191        4,440        18,396        -22

Marketing and administrative (1)

     3,164        3,222        3,175        3,192        3,537        13,125        -2

Research and development (1)

     2,158        2,051        2,179        2,322        4,559        11,111        5

Restructuring costs

     (14     288        526        50        121        985        *   

Equity income from affiliates

     (138     (138     (43     (236     (171     (587     —     

Other (income) expense, net

     622        167        (281     1,108        309        1,304        *   

Income (Loss) Before Taxes

     1,729        616        1,241        498        (701     1,653        *   

Income Tax Provision (Benefit)

     658        286        461        126        (201     671     

Net Income (Loss)

     1,071        330        780        372        (500     982        *   

Less: Net Income Attributable to Noncontrolling Interests

     28        31        28        30        31        121     

Net Income (Loss) Attributable to Merck & Co., Inc.

   $ 1,043      $ 299      $ 752      $ 342      $ (531   $ 861        *   

Earnings (Loss) per Common Share Assuming Dilution

   $ 0.34      $ 0.09      $ 0.24      $ 0.11      $ (0.17   $ 0.28        *   

Average Shares Outstanding Assuming Dilution

     3,104        3,141        3,125        3,102        3,081        3,120     

Tax Rate

     38.1     46.4     37.1     25.3     28.7     40.6  

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

*³ 100%

 

(1) Amounts in 2010 include a reclassification of certain expenses from marketing and administrative to research and development of $24 million, $28 million, $26 million, $42 million and $120 million in 1Q, 2Q, 3Q, 4Q and full year, respectively.


MERCK & CO., INC.

CONSOLIDATED STATEMENT OF OPERATIONS

GAAP TO NON-GAAP RECONCILIATION

FIRST QUARTER 2010

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2b

 

     GAAP     Purchase
Accounting  (1)
    Restructuring
Costs  (2)
    Merger-Related
Costs  (3)
    Adjustment
Subtotal
    Non-GAAP  

Sales

   $ 11,422            $ —        $ 11,422   

Materials and production

     5,216        2,347        57          2,404        2,812   

Marketing and administrative

     3,222            80        80        3,142   

Research and development

     2,051        27        6          33        2,018   

Restructuring costs

     288          288          288        —     

Equity income from affiliates

     (138           —          (138

Other (income) expense, net

     167            7        7        160   

Income Before Taxes

     616        (2,374     (351     (87     (2,812     3,428   

Taxes on Income

     286              (503 (4)      789   

Net Income

     330              (2,309     2,639   

Less: Net Income Attributable to Noncontrolling Interests

     31              —          31   

Net Income Attributable to Merck & Co., Inc.

   $ 299            $ (2,309   $ 2,608   

Earnings per Common Share Assuming Dilution

   $ 0.09              $ 0.83  (5) 

Average Shares Outstanding Assuming Dilution

     3,141                3,141   

Tax Rate

     46.4             23.0

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 and the amortization of purchase accounting adjustments to inventories recognized as a result of the merger. 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.
(3) Merger-related costs include transaction and integration costs associated with the merger.
(4) Includes a charge of $147 million associated with a change in tax law enacted as part of U.S. health care reform legislation, as well as the estimated tax impact on the reconciling items.
(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 non-GAAP earnings per common share assuming dilution was $2,596 million for the first quarter of 2010.


MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

FIRST QUARTER 2011

(AMOUNTS IN MILLIONS)

Table 3a

 

 

     Global      U.S.      International  
     1Q11      1Q10      % Change      1Q11      1Q10      % Change      1Q11      1Q10      % Change  

TOTAL SALES (1)

   $ 11,580       $ 11,422         1       $ 4,848       $ 4,998         -3       $ 6,732       $ 6,424         5   
                                                                                

PHARMACEUTICAL (2)

     9,820         9,665         2         3,907         4,072         -4         5,912         5,593         6   

Cardiovascular

                          

Zetia

     582         534         9         298         281         6         284         253         12   

Vytorin

     480         477         1         247         254         -3         233         222         5   

Integrilin

     64         70         -9         59         65         -9         5         5         -4   

Diabetes & Obesity

                          

Januvia

     739         511         45         426         354         20         313         157         *   

Janumet

     305         201         52         163         125         30         142         76         88   

Diversified Brands

                          

Cozaar / Hyzaar

     426         782         -46         36         291         -87         389         490         -21   

Zocor

     127         116         10         8         10         -18         119         106         13   

Claritin Rx

     120         98         23                  120         98         23   

Propecia

     106         100         7         32         35         -9         74         64         16   

Proscar

     60         58         3         2         2         1         59         57         3   

Remeron

     60         51         18         2         1         58         58         49         17   

Vasotec / Vaseretic

     57         59         -4                  57         59         -4   

Infectious Disease

                          

Isentress

     292         232         26         150         111         34         143         121         18   

PegIntron

     166         186         -11         18         26         -31         148         161         -8   

Cancidas

     158         153         3         12         15         -19         146         138         6   

Primaxin

     136         159         -14         25         35         -29         111         124         -10   

Avelox

     106         106         1         97         101         -4         10         4         *   

Invanz

     87         75         16         44         38         16         42         37         16   

Noxafil

     55         49         12         16         12         28         39         37         6   

Rebetol

     53         56         -7                  53         56         -7   

Crixivan / Stocrin

     45         52         -13         2         3         -39         43         49         -12   

Neurosciences & Ophthalmology

                          

Maxalt

     173         135         29         132         83         59         41         52         -20   

Cosopt / Trusopt

     114         115         -1         4         5         -36         111         109         1   

Oncology

                          

Temodar

     248         274         -10         102         92         11         145         182         -20   

Emend

     87         84         4         51         51         -1         36         32         11   

Intron A

     49         54         -11         26         30         -16         23         24         -4   

Respiratory & Immunology

                          

Singulair

     1,328         1,165         14         810         728         11         518         437         19   

Remicade

     753         674         12                  753         674         12   

Nasonex

     373         320         17         156         155         1         216         164         32   

Clarinex

     155         164         -5         47         49         -5         109         114         -5   

Arcoxia

     114         95         19                  114         95         19   

Asmanex

     60         51         17         54         49         11         5         2         *   

Simponi

     54         10         *                  54         10         *   

Proventil

     42         57         -26         39         56         -29         3         1         *   

Dulera

     13            *         13            *            

Vaccines

                          

ProQuad, M-M-R II and Varivax

     244         319         -23         226         296         -24         19         23         -18   

Gardasil

     214         233         -8         151         156         -3         63         77         -18   

RotaTeq

     125         93         35         107         74         46         18         19         -8   

Pneumovax

     79         51         55         60         40         50         19         11         75   

Zostavax

     24         95         -74         22         95         -77         2            *   

Women’s Health & Endocrine

                          

Fosamax

     208         230         -10         13         25         -50         195         205         -5   

NuvaRing

     142         135         5         87         83         4         56         52         7   

Follistim AQ

     133         134            38         41         -7         95         93         3   

Implanon

     60         51         18         24         19         27         35         31         12   

Cerazette

     59         55         7                  59         55         7   

Other Pharmaceutical (3)

     745         946         -21         109         181         -40         637         765         -17   

ANIMAL HEALTH

     758         709         7         164         140         17         594         569         4   

CONSUMER CARE (2)

     517         489         6         357         338         6         161         151         6   

Claritin OTC

     167         136         22         132         102         29         34         34         1   

Other Revenues (4)

     486         559         -13         421         448         -6         65         111         -41   

Astra

     322         364         -11         322         364         -11            
* 

100% or over

(1) 

Only select products are shown.

(2) 

In the first quarter of 2011, Merck changed the reporting for certain over -the-counter products. Sales of these products outside the United States were previously recorded in the Pharmaceutical business, and are now reported in the Consumer Care business. Prior period amounts have been recast on a comparative basis.

(3)

Includes pharmaceutical products not individually shown above. Other Vaccines sales included in Other Pharmaceutical were $54 million and $55 million on a global basis for first quarter 2011 and 2010, respectively.

(4)

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


MERCK & CO., INC.

PHARMACEUTICAL GEOGRAPHIC SALES

(AMOUNTS IN MILLIONS)

Table 3b

 

     1Q11     1Q10     2Q10     3Q10     4Q10     Full Year     %
Change

1Q
 

TOTAL PHARMACEUTICAL

   $ 9,820      $ 9,665      $ 9,638      $ 9,523      $ 10,441      $ 39,267        2   
                                                        

United States

     3,907        4,072        4,026        4,265        4,384        16,748        -4   

% Pharmaceutical Sales

     39.8     42.1     41.8     44.8     42.0     42.7  

Europe (1)

     2,587        2,810        2,631        2,342        2,677        10,459        -8   

% Pharmaceutical Sales

     26.3     29.1     27.3     24.6     25.6     26.6  

Japan

     1,164        811        902        855        1,077        3,645        44   

% Pharmaceutical Sales

     11.8     8.4     9.4     9.0     10.3     9.3  

Latin America

     700        659        696        699        778        2,832        6   

% Pharmaceutical Sales

     7.1     6.8     7.2     7.3     7.5     7.2  

Asia Pacific

     699        561        622        618        702        2,503        25   

% Pharmaceutical Sales

     7.1     5.8     6.5     6.5     6.7     6.4  

China

     187        133        159        145        173        611        40   

Eastern Europe/Middle East Africa

     358        375        395        353        393        1,516        -5   

% Pharmaceutical Sales

     3.6     3.9     4.1     3.7     3.8     3.9  

Canada

     360        337        328        374        364        1,403        7   

% Pharmaceutical Sales

     3.7     3.5     3.4     3.9     3.5     3.6  

Other

     45        40        37        17        67        161        13   

% Pharmaceutical Sales

     0.5     0.4     0.4     0.2     0.6     0.4  

 

(1) Europe primarily represents all European Union countries and the European Union accession markets.


MERCK & CO., INC.

EQUITY INCOME / JV SALES / OTHER (INCOME) EXPENSE - GAAP

FIRST QUARTER 2011

Table 4

 

 

EQUITY INCOME FROM AFFILIATES (millions of dollars)

     1Q11      1Q10  

ASTRAZENECA LP

   $ 133       $ 125   

Other (1)

     5         13   
                 

TOTAL

   $ 138       $ 138   
                 

 

(1)

Primarily reflects results for Sanofi Pasteur MSD and Johnson & JohnsonºMerck Consumer Pharmaceuticals.

 

 

 

SANOFI PASTEUR MSD JOINT VENTURE SALES DETAIL (millions of dollars)

All sales reported here are end-market JV sales, presented on a “NET” basis.

 

     1Q11      1Q10  

GARDASIL

   $ 58       $ 82   

OTHER VIRAL VACCINES

     19         23   

HEPATITIS VACCINES

     10         6   

ROTATEQ

     9         12   

FLU VACCINES

     2         10   

Other Vaccines

     89         118   
                 

TOTAL SANOFI PASTEUR MSD SALES

   $ 187       $ 251   
                 

 

 

 

OTHER (INCOME) EXPENSE, NET (millions of dollars)

 

     1Q11     1Q10  

INTEREST INCOME

   $ (41   $ (12

INTEREST EXPENSE

     186        181   

EXCHANGE LOSSES

     42        80   

Other, net (1)

     435        (82
                

TOTAL

   $ 622      $ 167   
                

 

(1) 

Other, net in the first quarter of 2011 includes a $500 million charge related to the resolution of the arbitration proceeding with Johnson & Johnson.

 

 

 

EX-99.3 4 dex993.htm PRESS RELEASE ISSUED APRIL 27, 2011 Press release issued April 27, 2011

Exhibit 99.3

 

LOGO    News Release

 

 

 

Media Contacts:    Steven Campanini    Investor Contacts:    Joe Romanelli
   (908) 423-4291       (908) 423-5088
   David Caouette       Carol Ferguson
   (908) 423-3461       (908) 423-4465

Merck Announces New $5 Billion Share Repurchase Program

WHITEHOUSE STATION, N.J., Wednesday, April 27, 2011 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that its Board of Directors has approved additional purchases of up to $5 billion of Merck’s common stock for its treasury. The treasury stock purchase has no time limit and will be made over time on the open market, in block transactions or in privately negotiated transactions.

“Merck has a history of leadership in returning cash to shareholders,” said Kenneth C. Frazier, Merck’s president and chief executive officer. “Together with our strong dividend, today’s action reflects our confidence in Merck’s strategy and demonstrates our commitment to delivering shareholder value.

“The company’s total current share repurchase program is now $6.4 billion, with today’s announcement and the $1.4 billion share repurchase authorization remaining under the program announced on November 24, 2009.

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.

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 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; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally 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 2010 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).

# # #

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